Vallejo City Council
March 28, 2023

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A
1,000,000
GLD1313807
CLE-006828441-01
5,000,000
X
5,000,000
DEDUCTIBLE:

N
3 01/01/2022
01/01/2023
Professional Liability
2,000,000
1,000,000
A
X
X
01/06/2022
250,000
01/01/2022

SEE ATTACHED
For Bid or Proposal Purposes Only
X
Monrovia, CA 91016
Eurofins Eaton Analytical, LLC
A
CN134111012-ALL-GUPP-21-22
LIMITS:
10,000
CUD1314007
2,000,000
41343
1,000,000
01/01/2023
1717 Arch Street
Marsh USA Inc.

X
Philadelphia, PA 19103-2797
750 Royal Oaks Drive, Suite 100
Eurofins Eaton Analytical, Inc.

Monrovia, CA 91016
EOD1313907
750 Royal Oaks Drive, Suite 100,
01/01/2022
01/01/2023
HDI Global America Insurance Company
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Limits:

Aggregate - $1,000,000
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Pollution Liability:
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(b) $5,000,000 Policy Aggregate Limit
(a) $5,000,000 each Claim (or each series of Related Claims) (c) $2,500,000 sublimit each Claim and in the aggregate for Defense Expenses in respect of Patent Infringement Professional Liability:
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Policy # PEC0058168
Indian Harbor Insurance Company
Each Pollution Condition - $1,000,000
SIR - $100,000
Marsh USA Inc.
750 Royal Oaks Drive, Suite 100
Eurofins Eaton Analytical, Inc.

Monrovia, CA 91016
ÓÎ
01/01/2021 - 01/01/2024
Professional Services Agreement (Revised 01.2019) Page 1 of 11

PROFESSIONAL SERVICES AGREEMENT
This Professional Services Agreement ("Agreement") is made at Vallejo, California, dated for reference this 6
th day of March, 2023, by and between the City
of Vallejo, a municipal corporation ("City"), and Alpha Analytical Labs, Inc., a California Corporation, hereinafter referred to as “Service Provider”, who agree as follows:

1. Services. Subject to the terms and conditions set forth in this Agreement, Service Provider shall provide the City professional services as specified in Exhibit A, entitled “Scope of Work.”

2. Payment. City shall pay Service Provider for services rendered pursuant to this Agreement at the times and in the manner set forth in Exhibit B, entitled “Compensation.” The payments specified in Exhibit B shall be the only payments to be made to Service Provider for services rendered pursuant to this Agreement.

3. Facilities and Equipment. Service Provider shall, at its sole cost and expense, furnish all facilities and equipment which may be required for furnishing services pursuant to this Agreement.

4. Indemnification. Service Provider shall indemnify, hold harmless, and defend City, its officers, officials, directors, employees, agents, volunteers and affiliates and each of them from any and all claims, demands, causes of action, damages, costs, expenses, actual attorney’s fees, Service Provider’s fees, expert fees, losses or liability, in law or in equity, of every kind and nature whatsoever arising out of or in connection with Service Provider’s operations, or any subcontractor’s operations, to be performed under this agreement for Service Provider’s or subcontractor’s tort negligence including active or passive, or strict negligence, including but not limited to personal injury including, but not limited to bodily injury, emotional injury, sickness or disease, or death to persons and/or damage to property of anyone, including loss of use thereof, caused or alleged to be caused by any act or omission of Service Provider, or any subcontractor, or anyone directly or indirectly employed by any of them or anyone for the full period of time allowed by the law, regardless to any limitation by insurance, with the exception of the sole negligence or willful misconduct of the City.

The provisions of this section shall survive the expiration or termination of this Agreement.

5. Insurance Requirements. Service Provider agrees to comply with all of the Insurance Requirements set forth in Exhibit C, entitled “Insurance Requirements.” Failure to maintain required insurance at all times shall constitute a default and material breach.

Professional Services Agreement (Revised 01.2019) Page 2 of 11

6. Accident Reports. Service Provider shall immediately report (as soon as feasible, but not more than 24 hours) to the City Risk Manager any accident or other occurrence causing injury to persons or property during the performance of this Agreement. The report shall be made in writing and shall include, at a minimum: (a) the names, addresses, and telephone numbers of the persons involved, (b) the names, addresses, and telephone numbers of any known witnesses, (c) the date, time, and description of the accident or other occurrence.

7. Conflict of Interest. Service Provider warrants and represents that to the best of its knowledge, there exists no actual or potential conflict between Service Provider’s family, business, real property or financial interests and the services to be provided under this Agreement. Service Provider shall comply with the City of Vallejo Conflict of Interest Code and not enter into any contract or agreement during the performance of this Agreement which will create a conflict of interest with its duties to City under this Agreement. In the event of a change in Service Provider’s family, business, real property, or financial interests occurs during the term of this Agreement that creates an actual or potential conflict of interest, then Service Provider shall disclose such conflict in writing to City. Every individual who performs services on behalf of Service Provider pursuant to this Agreement must file a full Statement of Economic Interests (also known as Form 700) with the City Clerk if the work of the individual involves making a governmental decision whether to issue, deny, suspend, or revoke any permit, license, application, certificate, approval, order, or similar authorization or entitlement; authorizes the City to enter into, modify, or renew a contract; grants City approval of specifications for a contract; adopts or approves for the City any policy, standard or guideline; lobbies on behalf of the City, or performs the same or substantially all the same duties for the City that would otherwise be performed by an individual holding a position specified in the City’s Conflict of Interest Code.

8. Independent Contractor. Service Provider is an independent contractor.

Neither Service Provider nor any of Service Provider’s officers, employees, agents, or subcontractors, if any, is an employee of City by virtue of this Agreement or performance of any services pursuant to this Agreement. City shall have the right to control Service Provider only insofar as the results of Service Provider’s services rendered pursuant to this Agreement; however, City shall not have the right to control the means by which Service Provider accomplishes services pursuant to this Agreement.

9. Licenses, Permits, Etc. Service Provider represents and warrants to City that all Service Provider services shall be provided by a person or persons duly licensed by the State of California to provide the type of services to be performed under this Agreement and that Service Provider has all the permits, qualifications and approvals of whatsoever nature which are legally required for Service Provider to practice its profession. Service Provider represents and warrants to City that it shall, at its sole cost and expense, keep in effect at all times during the term of this Professional Services Agreement (Revised 01.2019) Page 3 of 11 Agreement any licenses, permits, and approvals which are legally required for Service Provider to practice its profession.

10. Business License. Service Provider, and its subcontractors, has obtained or agrees to apply prior to performing any services under this Agreement to City’s Finance Department for a business license, pay the applicable business license tax and maintain said business license during the term of this Agreement. The failure to obtain such license shall be a material breach of this Agreement and grounds for termination by City. No payments shall be made to Service Provider until such business license(s) has been obtained.

11. Standard of Performance. Service Provider shall provide products and perform all services required pursuant to this Agreement in accordance with generally accepted professional practices and principles and in a manner consistent with the level of care and skill ordinarily exercised under similar conditions by a member of Service Provider’s profession currently practicing in California.

Service Provider is responsible for making an independent evaluation and judgment of all conditions affecting performance of the work, including without limitation applicable federal, state, and local laws and regulations, and all other contingencies or considerations.

Service Provider’s responsibilities under this section shall not be delegated.

Service Provider shall be responsible to City for acts, errors, or omissions of Service Provider’s subcontractors.

Service Provider is responsible for making an independent evaluation and judgment of all conditions affecting performance of the work and shall prepare plans, reports, and/or other work products in such a way that additional costs will not be incurred beyond a project budget approved or amended by the City Manager or his or her designee.

Whenever the scope of work requires or permits review, approval, conditional approval or disapproval by City, it is understood that such review, approval, conditional approval or disapproval is solely for the purposes of administering this Agreement and determining whether the Service Provider is entitled to payment for such work, and not be construed as a waiver of any breach or acceptance by the City of any responsibility, professional or otherwise, for the work, and shall not relieve the Service Provider of responsibility for complying with the standard of performance or laws, regulations, industry standards, or from liability for damages caused by negligent acts, errors, omissions, noncompliance with industry standards, or the willful misconduct of Service Provider.

12. Force Majeure. Neither party shall be considered in default of this Agreement to the extent performances are prevented or delayed by causes or Professional Services Agreement (Revised 01.2019) Page 4 of 11 circumstances beyond either party’s reasonable control, such as war, riots, strikes, lockouts, work slowdown or stoppage, acts of God, such as floods or earthquakes, and electrical blackouts or brownouts.

In the event that the Service Provider is unable to meet the completion date or schedule of services, Service Provider shall immediately inform the City Representative of this in writing. If additional time is required to perform the work, the City Representative may adjust the schedule.

13. Time is of the Essence. Time is of the essence in this Agreement. Any reference to days means calendar days, unless otherwise specifically stated.

14. Personnel. Service Provider agrees to assign only competent personnel according to the reasonable and customary standards of training and experience in the relevant field to perform services under this Agreement. Failure to assign such competent personnel shall constitute grounds for termination of this Agreement.

The payment made to Service Provider pursuant to this Agreement shall be the full and complete compensation to which Service Provider and Service Provider’s officers, employees, agents, and subcontractors are entitled for performance of any work under this Agreement. Neither Service Provider nor Service Provider’s officers or employees are entitled to any salary or wages, or retirement, health, leave or other fringe benefits applicable to employees of the City. The City will not make any federal or state tax withholdings on behalf of Service Provider. The City shall not be required to pay any workers' compensation insurance on behalf of Service Provider.

Service Provider shall pay, when and as due, any and all taxes incurred as a result of Service Provider’s compensation hereunder, including estimated taxes, and shall provide City with proof of such payments upon request.

15. Service Provider Not Agent. Except as authorized under this Agreement or as City may authorize in a letter of authorization signed by the City Manager or his or her designee, Service Provider shall have no authority, express or implied to act on behalf of City in any capacity whatsoever as an agent. Service Provider shall have no authority, express or implied, under this Agreement, to bind City to any obligation whatsoever.

16. Term. The term of this Agreement shall commence on March 29, 2023 and shall continue in full force and effect until June 30, 2028.

If the term of this Agreement extends into fiscal years subsequent to that in which it is approved, such continuation of the Agreement is contingent on the appropriation of funds for such purpose by the City Council of the City of Vallejo.

If funds to effect such continued payment are not appropriated, Service Provider Professional Services Agreement (Revised 01.2019) Page 5 of 11 agrees to terminate any services supplied to City of Vallejo under this Agreement, and relieve City of any further obligation therefore.

17. Termination or Abandonment by City. The City has the right, at any time and in its sole discretion, to immediately terminate or abandon any portion or all of the services to be provided under this Agreement by giving notice to Service Provider. Upon receipt of a notice of termination, Service Provider shall perform no further work except as specified in the notice. Before the date of termination, Service Provider shall deliver to City all City records and documents, all work product, whether completed or not, as of the date of termination and not otherwise previously delivered.

The City shall pay Service Provider for services performed in accordance with this Agreement before the date of termination. If this contract provides for payment of a lump sum for all services or by task and termination occurs before completion of the work or any defined task which according to the performance schedule was commenced before the notice of termination, the fee for services performed shall be based on an amount mutually agreed to by City and Service Provider for the portion of work completed in conformance with this Agreement before the date of termination. In addition, the City will reimburse Service Provider for authorized expenses incurred and not previously reimbursed. The City shall not be liable for any fees or costs associated for the termination or abandonment except for the fees, and reimbursement of authorized expenses, payable pursuant to this section.

18. Products of Consulting Services. The work product, including without limitation, all writings, work sheets, reports, recordings, drawings, files, detailed calculations and other work products, whether complete or incomplete, of Service Provider resulting from services rendered pursuant to this Agreement, shall become the property of City. Service Provider agrees that all copyrights which arise from creation of the work under this Agreement shall be vested in the City and waives and relinquishes all claims to copyright or other intellectual property rights in favor of the City. City acknowledges that its use of the work product is limited to the purposes contemplated by the scope of work and that the Service Provider makes no representation of the suitability of the work product for use in or application to circumstances not contemplated by the scope of work.

Documents submitted to the City in electronic format shall be formatted according to specifications provided by the City, or if not otherwise specified, in Microsoft Word, Excel, PowerPoint or other Microsoft Office Suite (2002) format as appropriate for the particular work product or, if directed by the City Representative in Adobe Acrobat PDF format.

19. Cooperation by City. City shall, to the extent reasonable and practicable, assist and cooperate with Service Provider in the performance of Service Provider’s services hereunder.

Professional Services Agreement (Revised 01.2019) Page 6 of 11

20. Assignment and Subcontracting. Service Provider shall not subcontract, assign or transfer voluntarily or involuntarily any of its rights, duties or obligation under this Agreement without the express written consent of the City Manager or his or her designee in each instance. Any attempted or purported assignment of any right, duty or obligation under this Agreement without said consent shall be void and of no effect.

If subcontracting of work is permitted, Service Provider shall pay its subcontractor within ten (10) days of receipt of payment by City for work performed by a subcontractor and billed by the Service Provider. Use of the term subcontractor in any other provision of this contract shall not be construed to imply authorization for Service Provider to use subcontractors for performance of any service under this Agreement.

The City is an intended beneficiary of any work performed by Service Provider’s subcontractor for purposes of establishing a duty of care between the subcontractor and City.

Any subcontractor or assignee consented to by City shall be bound by all terms and conditions of this agreement and the same shall be incorporated into and made a part of any assignment or subcontractor agreement.

21. Successors and Assigns. All terms, conditions, and provisions of this Agreement shall apply to and bind the respective heirs, executors, administrators, successors, and assigns of the parties. Nothing in this section is intended to affect the limitation on assignment.

22. Non-Discrimination/Fair Employment Practices.
(a) Service Provider shall not, because of race, religious creed, color, sex, national original, ancestry, disability, medical condition, age, marital status or sexual orientation of any person, refuse to hire or employ, or to bar or discharge from employment, or to discriminate in compensation, or in terms, conditions or privileges any person, and every employee will receive equal opportunity for employment and shall be granted equal treatment with respect to compensation, terms, conditions or other privileges of employment, without regard to his race, religious creed, color, sex, national origin, ancestry, or disability, medical condition, age, marital status or sexual orientation.

Service Provider warrants and represents it is an equal opportunity employer and agrees it shall not discriminate on the basis of race, religious creed, color, sex, national origin, ancestry, disability, medical condition, age, marital status or sexual orientation in the selection and retention of employees, subcontractors or procurement of materials or equipment.

In all solicitations either by competitive bidding or negotiations made by Service Professional Services Agreement (Revised 01.2019) Page 7 of 11 Provider for work to be performed under any subcontract, including procurement of materials or equipment, each potential subcontractor or supplier shall be notified by Service Provider of Service Provider’s obligation under this Agreement relative to nondiscrimination and fair employment practices.

Service Provider shall include the above provisions of this section in every subcontract, including procurement of materials or equipment. (b) Service Provider agrees to comply with Title VII of the Civil Rights Act of 1964, as amended, the California Fair Employment Practices Act, the Americans with Disabilities Act of 1990, any other applicable federal and state laws and regulations and City ordinances and regulations hereinafter enacted.

23. Notices. All notices or instruments required to be given or delivered by law or this Agreement shall be in writing and shall be effective upon receipt thereof and shall be by personal service or delivered by depositing the same in any United States Post Office, registered or certified mail, postage prepaid, addressed to:

If to City:

Beth Schoenberger
Water Director
City of Vallejo – Water Department
202 Fleming Hill Road
Vallejo, CA 94589
If to Service Provider:

Robbie C. Phillips
President
Alpha Analytical Labs, Inc.
262 Rickenbacker Circle
Livermore, CA 94551
Any party may change its address for receiving notices by giving written notice of such change to the other party in accordance with this section.

Routine administrative communications shall be made pursuant to section 1 of Exhibit A.

24. Integration Clause. This Agreement, including all Exhibits, contains the entire agreement between the parties and supersedes whatever oral or written understanding they may have had prior to the execution of this Agreement. This Agreement shall not be amended or modified except by a written agreement Professional Services Agreement (Revised 01.2019) Page 8 of 11 executed by each of the parties hereto.

25. Severability Clause. Should any provision of this Agreement ever be deemed to be legally void or unenforceable, all remaining provisions shall survive and be enforceable.

26. Law Governing. This Agreement shall in all respects be governed by the law of the State of California without regard to its conflicts of law rules. Litigation arising out of or connected with this Agreement shall be instituted and maintained in the courts of Solano County in the State of California or in the United States District Court, Eastern District of California, Sacramento, California, and the parties consent to jurisdiction over their person and over the subject matter of any such litigation in such courts, and consent to service of process issued by such courts.

27. Waiver. Waiver by either party of any default, breach or condition precedent shall not be construed as a waiver of any other default, breach or condition precedent or any other right hereunder.

28. Ambiguity. The parties acknowledge that this is a negotiated agreement, that they have had the opportunity to have this Agreement reviewed by their respective legal counsel, and that the terms and conditions of this Agreement are not to be construed against any party on the basis of such party's draftsmanship thereof.

29. Gender. All pronouns and any variations thereof shall be deemed to refer to the masculine, feminine, neuter, singular or plural, as the identifications of the person or persons, firm or firms, corporation or corporations may require.

30. Headings. The section headings contained in this Agreement are inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement.

31. Compliance with Laws. Service Provider will comply with all statutes, regulations and ordinances in the performance of all services under this Agreement.

32. Confidentiality of City Information. During the performance of services under this Agreement, Service Provider may gain access to and use City information regarding, but not limited to, procedures, policies, training, operational practices, and other vital information (hereafter collectively referred to as "City Information") which are valuable, special and unique assets of the City. Service Provider agrees that it will not use any information obtained as a consequence of the performance of services under this Agreement for any purpose other than fulfillment of Service Provider’s scope of work , to protect all City Information and treat it as strictly confidential and proprietary to City, and that it will not at any time, either directly or indirectly, divulge, disclose or communicate in any manner any Professional Services Agreement (Revised 01.2019) Page 9 of 11 City Information to any third party, other than its own employees, agents or subcontractors who have a need for the City Information for the performance of services under this Agreement, without the prior written consent of City, or as required by law.

Service Provider shall treat all records and work product prepared or maintained by Service Provider in the performance of this Agreement as confidential.

A violation by Service Provider of this section shall be a material violation of this Agreement and will justify legal and/or equitable relief.

Service Provider’s obligations under this section shall survive the completion of services, expiration or termination of this Agreement.

33. News and Information Release. Service Provider agrees that it will not issue any news releases in connection with either the award of this Agreement, or any subsequent amendment of or efforts under this Agreement, without first obtaining review and approval of said news releases from City through the City Representative.

34. City Representative. The City Representative specified in Exhibit A, or the representative's designee, shall administer this Agreement for the City.

35. Counterparts. The parties may execute this Agreement in one or more counterparts, each of which shall be deemed an original, but all of which together shall be deemed one and the same instrument.

36. Facsimile Signature; Electronic Signature. This Agreement shall be binding upon the receipt of facsimile signatures or e-mailed by PDF or otherwise.

Any person transmitting his or her signature by facsimile or electronically shall promptly send an original signature to the other party pursuant to the notice provision of this Agreement. The failure to send an original shall not affect the binding nature of this Agreement.

37. Authority. The person signing this Agreement for Service Provider hereby represents and warrants that he/she is fully authorized to sign this Agreement on behalf of Service Provider.

38. Exhibits. The following exhibits are attached hereto and incorporated herein by reference:

Exhibit A, entitled “Scope of Work,” including any attachments Exhibit B, entitled “Compensation,” including any attachments Exhibit C, entitled “Insurance Requirements,” including attachments Professional Services Agreement (Revised 01.2019) Page 10 of 11 [SIGNATURES ON FOLLOWING PAGE]
Professional Services Agreement (Revised 01.2019) Page 11 of 11 IN WITNESS WHEREOF, the parties have executed this Agreement on the day and year shown below the name of each of the parties.

ALPHA ANALYTICAL LABS, INC.
a California corporation
By:

Robbie C. Phillips
President
DATE:
11700042
Vallejo Business License No.
(City Seal)

CITY OF VALLEJO,
a municipal corporation
By:

Mike Malone
City Manager
DATE:

ATTEST:

By:

Dawn Abrahamson
City Clerk

APPROVED AS TO CONTENT
By:

Beth Schoenberger
Water Director
APPROVED AS TO FORM:

By: For:

Veronica A.F. Nebb
City Attorney
APPROVED AS TO INSURANCE:

By:

Armond Sarkis
Risk Manager
Professional Services Agreement (Revised 01.2019) Page 1 of 4 Exhibit A – Scope of Work

EXHIBIT A

SCOPE OF WORK

1. Representatives. The City Representative for this Agreement is:

Vidia Gillula
Water Quality Manager
City of Vallejo - Water Department
202 Fleming Hill Road
Vallejo, CA 94589
707-649-3472
[email protected]
The Service Provider’s Representative for this Agreement is:

Robbie C. Phillips
President
Alpha Analytical Labs, Inc.
262 Rickenbacker Circle
Livermore, CA 94551
925-828-6226
[email protected]
All routine administrative communications between the parties will be between the above-named representatives and may be by personal delivery, mail, facsimile transmission, or electronic mail as agreed between the Service Provider Representative and City’s Representative.

2. Services to be Provided. The services provided shall be as follows:

1. The project includes furnishing all labor, materials, tools, transportation, equipment, all sample containers, equipment, and facilities required for sample analysis, and analysis report preparation and delivery to the City of Vallejo in accordance with the schedule and procedures described herein. The Service Provider will provide testing services on all waters (source, drinking, and surface), solid samples with parameter(s) to be determined by the City.

Samples to be tested will be collected by the City. Courier services to the analytical lab will be furnished by the Service Provider.

2. The work is to be performed by a Service Provider that is properly certified by NELAC / ELAP to perform the work required. In addition to specific State and USEPA requirements, all work shall comply with all applicable governmental regulations, project specific quality standards and industry-accepted good Professional Services Agreement (Revised 01.2019) Page 2 of 4 Exhibit A – Scope of Work
practices for the type of work being performed.

Project Coordination

1. The Service Provider shall coordinate with the City to ensure that all scheduling of sample pick up and analysis meets project-specific requirements and regulatory deadlines.

2. The Service Provider shall designate a primary point of contact and one alternate contact within the organization including emergency telephone numbers and email addresses.

3. Special samples may be provided by the City of Vallejo Laboratory at any time, and the Service Provider shall conduct testing and reporting on special samples on weekends, holidays, and after normal business hours as needed.

Sampling Materials (as Needed)

1. Service Provider must have the ability to supply sample bottles and materials for collection and handling of samples, including sample bottle kits and properly sized ice chests.

2. Service Provider must deliver the custom sample bottle kits to the City of Vallejo laboratory. Deliveries shall be made no later than the day before the scheduled sampling.

3. Service Provider must provide the City with disinfected sample coolers or blue-ice containers and preservatives for sample collection and transport, including blue-ice or wet ice for sample preservation.

Sample Pick-up/Shipping

1. Service Provider shall provide courier services for the pick-up and delivery of samples to the laboratory facility. Samples shall be picked up and delivered as requested, typically Monday-Friday 7:00 a.m.-5:00 p.m. Pacific Standard Time with additional sampling as needed on weekends and holidays.

2. Service Provider shall acknowledge receipt of samples by completing the chain-of-custody form for each set of samples and returning a copy of the completed chain-of-custody form with the corresponding analysis reports.

Analysis of Samples

1. Analysis shall be performed only within the procedures approved for the Service Provider under certification by NELAC / ELAP, and with appropriate quality Professional Services Agreement (Revised 01.2019) Page 3 of 4 Exhibit A – Scope of Work
assurance/quality control practices.

2. Methods shall be as described in accordance with 40 CFR Part 136 for the environmental programs, and water samples in accordance with Title 22 for the drinking water program.

3. The Service Provider must ensure that analysis performed shall have verifiable method detection levels (MDLs), Reporting Limits (RLs), Practical Quantitation limits (PQLs), instrument limits (ILs), and other limits consistent with USEPA and/or the City’s accepted standards.

4. The Service Provider shall provide the City with a list of all sub-contracting labs used for testing.

5. Standard turnaround time for analyses will be 2 weeks from sample receipt.

The Service Provider will also have personnel and facilities to complete expedited service upon request of the City.

Resampling/Analysis
If there is a need for the City to re-sample due to an error that is the fault of the contracted laboratory (i.e., requested analysis is not completed by the lab, sample is dropped, holding times are expired before analysis is complete, etc.), the analysis of the re-sample will be done at no additional charge to the City.

Reporting

1. The Service Provider shall prepare analysis reports to include the following information:
a. Sample identification and sample type
b. Sample preservation and container type
c. Analytical methodology used
d. Analytical results and corresponding method detection limits e. Names of individuals collecting or submitting the sample f. Date and time of sample collection
g. Laboratory performing the analysis for each parameter h. Quality control indices (metrics, RPD, spike, IPR, OPR, flags, etc.)

2. The Service Provider shall submit the analysis reports with the corresponding invoices for services.

3. The Service Provider must be able to provide reports in both electronic deliverable format (EDF) such that data can be integrated into LIMS, electronic data transfer (EDT) such that data can be reported to the state, and other electronic formats as requested by the City (CD, email, etc.).

Professional Services Agreement (Revised 01.2019) Page 4 of 4 Exhibit A – Scope of Work
Chain of Custody
The Service Provider shall complete the copy of the current Chain of Custody form initiated by the City and provide the Sample Receiving and Chain of Customer standard operating procedure.

Professional Services Agreement (Revised 01.2019) Page 1 of 3 Exhibit B - Compensation

EXHIBIT B

COMPENSATION

1. Service Provider’s Compensation.

A. Services: City agrees to pay Service Provider, at the rate(s) specified below, for those services set forth in Exhibit A of this Agreement and for all authorized reimbursable expenses, for a total not to exceed Seven Hundred Fifty Thousand Dollars and Zero Cents ($750,000.00).

Service Provider shall notify City in writing no later than thirty (30) days prior to the estimated date when Service Provider will have billed City the maximum payment amount permitted under this Agreement, and Service Provider shall provide City with an estimate of the additional compensation required to complete the project.

B. Additional Services:

1. Additional Services are those services related to the scope of Services of Service Provider as set forth in Exhibit A but not anticipated at the time of execution of this Agreement. Additional Services shall be provided only when a Supplemental Agreement authorizing such Additional Services is approved by the City Manager, or his or her designee. City reserves the right to perform any Additional Services with its own staff or to retain other Service Providers to perform said Additional Services.

2. Service Provider’s compensation for Additional Services shall be based on the total number of hours spent on Additional Services multiplied by the employees' appropriate billable hourly rate as established below. City, at its option, may negotiate a fixed fee for some or all Additional Services as the need arises.

Where a fixed fee for Additional Services is established by mutual Agreement between City and Service Provider, compensation to Service Provider shall not exceed the fixed fee amount.

2. Appropriate Rates for Services and Additional Services.

Service Provider’s rates shall be listed in Attachment 1 of Exhibit B, attached hereto and incorporated herein by this reference.

3. Service Provider’s Reimbursable Expenses. Reimbursable Expenses shall be limited to actual reasonable expenditures of Service Provider for expenses that are necessary for the proper completion of the Services and shall only be payable if specifically authorized in advance by City.

4. Payments to Service Provider.

Professional Services Agreement (Revised 01.2019) Page 2 of 3 Exhibit B - Compensation
A. Payments to Service Provider shall be made within a reasonable time after receipt of Service Provider’s invoice, said payments to be made in proportion to services performed. Service Provider may request payment on a monthly basis.

Service Provider shall be responsible for the cost of supplying all documentation necessary to verify the monthly billings to the satisfaction of City.

B. All invoices submitted by Service Provider shall contain the following information:

1. Description of services billed under this invoice

2. Date of Invoice Issuance

3. Sequential Invoice Number

4. City’s Purchase Order Number (if issued)

5. Social Security Number or Taxpayer Identification Number

6. Amount of this Invoice (Itemize all Reimbursable Expenses”)

7. Total Billed to Date
C. Items shall be separated into Services and Reimbursable Expenses.

Billings that do not conform to the format outlined above shall be returned to Service Provider for correction. City shall not be responsible for delays in payment to Service Provider resulting from Service Provider’s failure to comply with the invoice format described above.

D. Request for payment shall be sent to:

City of Vallejo Water Department
Accounting Clerk
Water Department
202 Fleming Hill Road
Vallejo, CA 94589
[email protected]

5. Accounting Records of Service Provider. Service Provider shall maintain for three (3) years after completion of all services hereunder, all records under this Agreement, including, but not limited to, records of Service Provider’s direct salary costs for all Services and Additional Services performed under this Agreement and records of Service Provider’s Reimbursable Expenses, in accordance with generally accepted accounting practices. Service Provider shall keep such records available for audit, inspection and copying by representatives of the City’s Finance Department or other government agencies during regular business hours upon twenty-four (24) hours’ notice.

The obligations of Service Provider under this section shall survive this Agreement.

6. Taxes. Service Provider shall pay, when and as due, any and all taxes Professional Services Agreement (Revised 01.2019) Page 3 of 3 Exhibit B - Compensation
incurred as a result of Service Provider’s compensation hereunder, including estimated taxes, and shall provide City with proof of such payments upon request.

7. Taxpayer Identification Number. Service Provider shall provide City with Service Provider’s complete Request for Taxpayer Identification Number and Certification, Form W-9, as issued by the Internal Revenue Service, and any other State or local tax identification number requested by City.

Professional Services Agreement (Revised 01.2019) Page 1 of 3 Exhibit C – Insurance Requirements

EXHIBIT C

INSURANCE REQUIREMENTS
Service Provider shall procure and maintain for the duration of this Agreement, including any extensions thereto, insurance against claims for injuries to persons or damages to property which may arise from or in connection with the performance of services hereunder by the Service Provider, their agents, representatives, or employees or subcontractors.

1. Minimum Scope of Insurance. Coverage shall be at least as broad as:

A. Insurance Services Office form number GL 0002 covering Comprehensive General Liability and Insurance Services Office form number GL 0404 covering Broad Form Comprehensive General Liability; or Insurance Services Office Commercial General Liability coverage (occurrence form CG 0001).

B. Insurance Services Office form number CA 0001 covering Automobile Liability, code 1 any auto and endorsement CA 0025.

C. Workers' Compensation insurance as required by the State of California and Employer's Liability Insurance.

D. Professional Liability insurance appropriate to the Service Provider’s profession (Errors and Omission).

2. Minimum Limits of Insurance. Service Provider shall maintain limits no less than:

A. General Liability: $5,000,000 per occurrence for bodily injury, personal injury, and property damage. If Commercial General Liability Insurance or other form with a general aggregate limit is used, either the general aggregate limit shall apply separately to this project/location or the general aggregate limit shall be twice the required occurrence limit.

B. Automobile Liability: $1,000,000 per accident for bodily injury and property damage.

C. Workers’ Compensation and Employer's Liability: $1,000,000 per accident for bodily injury or disease. If Service Provider is not subject to California Workers’ Compensation requirements, Service Provider shall file a completed certificate of exemption form which may be obtained from the City prior to commencing any activity authorized hereunder.

Professional Services Agreement (Revised 01.2019) Page 2 of 3 Exhibit C – Insurance Requirements
D. Professional Liability (Errors and Omission): $3,000,000 combined single limit per occurrence, and annual aggregate.

3. Deductible and Self-Insured Retention. Any deductibles or self-insured retention must be declared to and approved by the City. At the option of the City, either: the insurer shall reduce or eliminate such deductibles or self-insured retention as respects the City of Vallejo, its officers, officials, employees and volunteers; or the Service Provider shall procure a bond guaranteeing payment of losses and related investigations, claim administration and defense expenses.

4. Other Insurance Provisions. The general liability and automobile liability policies, as can be provided, are to contain, or be endorsed to contain, the following provisions:

A. The City of Vallejo, its officers, officials, employees, agents and volunteers are to be covered as additional insureds as respects; liability, including defense costs, arising out of activities performed by or on behalf of the Service Provider; products and completed operations of the Service Provider; premises owned, occupied or used by the Service Provider; or automobiles owned, leased hired or borrowed by the Service Provider. The coverage shall contain no special limitations on the scope of protection afforded to the City of Vallejo, its officers, officials, employees, agents or volunteers. The insurance is to be issued by companies licensed to do business in the State of California.

B. For any claims related to this project, the Service Provider's insurance coverage shall be primary insurance as respects the City of Vallejo, its officers, officials, employees, agents, and volunteers. Any insurance or self-insurance maintained by the City of Vallejo, its officers, officials, employees, agents, or volunteers shall be excess of the Service Provider's insurance and shall not contribute with it.

C. Any failure to comply with reporting or other provisions of the policies including breaches of warranties shall not affect coverage provided to the City, its officers, officials, employees, agents, or volunteers.

D. The Service Provider's insurance shall apply separately to each insured against whom claim is made or suit is brought, except with respect to the limits of the insurer's liability.

E. Each insurance policy required by this clause shall be endorsed to state that coverage shall not be suspended, voided, canceled by either party, reduced in coverage or in limits except after thirty (30) days' prior written notice by certified mail, return receipt requested, has been given to the City.

Professional Services Agreement (Revised 01.2019) Page 3 of 3 Exhibit C – Insurance Requirements
F. The workers’ compensation and employer’s liability policy required hereunder shall be endorsed to state that the workers' compensation carrier waives its right of subrogation against City, its officers, officials, employees, agents and volunteers, which might arise by reason of payment under such policy in connection with Service Provider’s performance under this Agreement.

5. Acceptability of Insurers. Insurance is to be placed with insurers with a current A.M. Best's rating of no less than A:VII.

6. Verification of Coverage. Service Provider shall furnish the City with certificates of insurance and original endorsements effecting general and automobile liability insurance coverage required by this clause. The certificates and endorsements are to be signed by a person authorized by that insurer to bind coverage on its behalf. All endorsements are to be received and approved by the City before work commences.

7. Subcontractors. Service Provider shall include all subcontractors as insureds under its policies or shall furnish separate certificates and endorsements for each subcontractor. All coverages for subcontractors shall be subject to all of the requirements stated herein.

8. Payment Withhold. City will withhold payments to Service Provider if the certificates of insurance and endorsements required in Paragraph F, above, are canceled or Service Provider otherwise ceases to be insured as required herein.

Alpha Labs, Inc. (Alpha) is a statewide laboratory network that specializes in supporting municipal operations for their regulatory compliance testing. More specifically, we’re setup to support the statewide drinking water program.

We have six locations across the state that are strategically located to assist with the analytical support of short hold time microbiology utilizing an extensive courier network to retrieve these samples and have them processed within the method hold time. Since we can offer microbiology support at a localized level, we then can facilitate the municipal operation’s chemistry needs for all their source water requirements.

We have been servicing the City of Vallejo drinking water operation for almost 10 years now. We understand their needs and make sure we’re always available to modify our service program to meet their ever changing regulatory compliance requirements.

We thank you for all your past business and hope we can continue servicing you and your team into the future.

Sincerely,
Robbie Phillips
President
RFP Questionnaire
a) Our laboratory operation started back in the mid-1970s and has since expanded throughout California over the years. We provide analytical services for small to very large public water distribution systems b) ELAP Certificates attached for both our Bay Area as well as our main chemistry facility in Ukiah. c) The City of Vallejo will be supported by our Bay Area facility location @ 262 Rickenbacker Circle, Livermore. We service the Vallejo area daily providing courier service support. d) We have six locations and we’re constantly under site audit schedules and are utilizing these audits to make corrections where needed and become stronger as a statewide compliance laboratory into the future. A copy of any of our 3rd party audits are available at anytime by request.

Laboratory Quality Assurance Plan
• Attached for review
Quality System Audits
• Attached for review
Statement of Qualifications
• Attached for review
Laboratory Experience
• City of Vallejo – 10 years of drinking water, ground water and sludge testing for regulatory compliance. The city’s water division is responsible for all potable water treatment and distribution for the City of Vallejo. • Sonoma County Water Agency – 25+ years of drinking water, wastewater and sludge testing for regulatory compliance. Sonoma County Water Agency is a water wholesaler while also managing and operating several NPDES treatment plants in the Sonoma County region.
• San Jose Water Company – 15 years of drinking water testing for regulatory compliance. The city provides treated drinking water to almost 1,000,000 residents.
• EBMUD – 10 years of drinking water , wastewater and sludge testing for regulatory compliance. They provide municipal services for several cities throughout the 580, 880 and 680 corridors. • City of Hayward – 15 years of wastewater, storm water and sludge testing for regulatory compliance. They have a large NPDES wastewater treatment plant along with a host of pre-treatment industrial dischargers that we continue to service as well.

Emergency Response
Robbie Phillips is the President of Alpha Labs, has almost 20 years of project management experience and will continue to be the City of Vallejo’s direct point of contact for all things related to this service contract. He has been the City of Vallejo’s project manager for the entire duration of our services to the city (10 years).

Title

QUALITY ASSURANCE PLAN
Alpha Analytical Laboratories, Inc.
208 Mason Street, Ukiah, CA 95482
Phone: 707-468-0401
Fax: 707-468-5267
www.alpha-labs.com
ELAP Certificate# 1551
Revised February 2019
Section 6 Revised October 2019
Approved by:

Name
Owner, President Robbie C. Phillips
Laboratory Director,
lnorganics Section Manager Martha Younger
Laboratory Director,
Organics Section Mana er
Wet Chemistry, Microbiology,
and Toxicity Section Mana er
Quality Manager
Nathan Holloway
Zee Hopper
Cheryl Watson
Date
lo-1?-19
t0-ff-l9
10· 1':1· I
This document for management system review only.

May not be used for any other purpose without written permission.

This page intentionally left blank
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019
Table of Contents
i

1. Introduction and Objectives ............................................................................................ 1

1.1 Specific Objectives................................................................................................ 1

1.2 QA/QC Components ............................................................................................. 1

2. Organization and Responsibilities.................................................................................. 2

2.1 Organization.......................................................................................................... 2

2.2 Responsibilities ..................................................................................................... 2

3. Sampling and Sample Management ............................................................................... 5

3.1 Collection of Samples ........................................................................................... 5

3.2 Handling of Samples ............................................................................................. 5

3.3 Sample Containers................................................................................................ 6

3.4 Preservation of Samples....................................................................................... 6

3.5 Sample Management............................................................................................ 6

4. Analysis and Calibration.................................................................................................. 8

4.1 Analytical Methods ................................................................................................ 8

4.2 Method Detection and Practical Quantitation Limits (MDLs and PQLs)............... 9

4.3 Calibration ............................................................................................................. 9

4.4 Confirmation........................................................................................................ 10

4.5 Preventive Maintenance...................................................................................... 10

5. Internal Quality Control.................................................................................................. 11

5.1 Blanks.................................................................................................................. 11

5.2 Laboratory Control Samples ............................................................................... 11

5.3 Matrix Spike/Matrix Spike Duplicates.................................................................. 11

5.3 Sample Duplicates .............................................................................................. 11

5.4 Surrogates........................................................................................................... 12

5.5 Control Limits ...................................................................................................... 12

5.6 Control Charts ..................................................................................................... 12

5.7 Corrective Action Procedures ............................................................................. 12

6. Data Reduction, Validation, and Reporting ................................................................. 14

6.1 Laboratory Notebooks......................................................................................... 14

6.2 Validation and Reporting of Data ........................................................................ 14

6.3 Backing Up and Archiving LIMS Data................................................................. 14

6.4 Quality Control Reports....................................................................................... 14

7. Safety ............................................................................................................................... 15

7.1 Policy Goals ........................................................................................................ 15

7.2 Organization........................................................................................................ 15

7.3 Chemical Hygiene Plan....................................................................................... 15

7.4 Emergency Action Plan....................................................................................... 15

7.5 Material Safety Data Sheets (MSDSs)................................................................15

7.6 Safety Training .................................................................................................... 15

8. Attachments .................................................................................................................... 16 This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019
Table of Contents
ii
A. Ethics and Integrity Policy and Data Integrity Agreement...................................16 B. Field Sheet .......................................................................................................... 18 C. Chain of Custody................................................................................................. 19 D. Sample Containers, Preservation, and Holding Times.......................................21 E Standard Operating Procedures (SOPs) ...........................................................32 F. Practical Quantitation Limits ............................................................................... 41 G. Major Instrumentation ......................................................................................... 54

7. Revisions......................................................................................................................... 56 This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

1. Introduction and Objectives

The purpose of the Alpha Analytical Quality Assurance/Quality Control (QA/QC) Plan is to establish and maintain laboratory practices that insure the scientific reliability and the legal defensibility of our data. This document is revised annually.

1.1 Specific Objectives

1. The primary objective of the QA/QC plan is to set a level of quality for each laboratory section and to insure that each section meets that level.

2. The QA/QC plan is designed to assist in the early recognition of deficiencies that might affect the quality of data submitted to clients.

1.2 QA/QC Components

1. Employee Training
Alpha Analytical Laboratory personnel are instructed by experienced Alpha employees under the direction of the section manager, or by the section manager directly. They are given copies of relevant methods and standard operating procedures (SOPs) with followup discussion of contents. Analysts must demonstrate method proficiency prior to unsupervised analysis of client samples and this proficiency documented.

2. Internal Quality Control
Quality control is practiced on all aspects of sampling, analytical systems, equipment, and data. In all cases, protocols for corrective action have been set up in case limits are not met. Specific measures are described in this document.

3. Performance Audits
Alpha Analytical participates in annual proficiency testing for drinking water, wastewater, and hazardous waste analyses as mandated by the State Water Resources Control Board Environmental Laboratory Accreditation Program.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

2. Organization and Responsibilties

Controller
Couriers Sample
Control
Personnel
Sample
Control
Manager
Field
Services
Personnel
Field
Services
Manager
Organics
Personnel
Organics
Section
Manager
Inorganics
Personnel
Inorganics
Section
Manager
Wet Chemistry
Microbiology
Toxicity
Personnel
Wet Chemistry
Microbiology
Toxicity
Section Manager
President Quality
Manager
Figure 1
QA/QC Organizational Chart for Alpha Analytical Laboratories

2.1 Organization
Figure 1 represents the QA/QC organizational structure of Alpha. The Sample Control Manager is assisted by eleven employees. In addition, the Sample Control Manager schedules a fleet of seven couriers. The field services department provides sampling and sample pick up. The department is staffed by three employees in addition to the manager. Field personnel and couriers maintain responsibility for samples in their custody until they are released to the laboratory. The analytical laboratory is divided into three sections: wet chemistry, inorganics, and organics. Each group has a manager who is responsible for the section's quality control. The organics section employs five analysts in addition to the manager, as well as six technicians. The inorganics manager oversees four analysts and three technicians. The wet chemistry section includes microbiology and toxicity. This section employs four analysts and thirteen technicians. QA/QC responsibilities of personnel are outlined below. In addition, employees are trained in and expected to perform their duties in accordance with Alpha’s ethics and data integrity policy. See Attachment A.

The Organics, Inorganics and Wet Chemistry/Microbiology/Toxicity Section Managers function as laboratory directors in that they are responsible for the analytical and operational activities of, supervision of personnel in, and the accuracy and quality of all data reported by the department each manages. If, for any reason, one of these managers leaves and is not replaced within 15 days by a person meeting the requirements specified in 22 CCR 64817 (a), a person or persons with lesser qualifications may serve as a temporary director for a period not to exceed ninety days, provided that the laboratory notifies the Department describing the qualifications of the temporary director and receives written confirmation from the Department. Records of notification and confirmation will be maintained.

2.2 Responsibilities
A. The President Will:

1. Provide support to Section Managers.

2. Approve resources necessary to do the work.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

2. Organization and Responsibilties

B. The Quality Manager Will:

1. Have general knowledge of the analytical tests the laboratory performs.

2. Report directly to management and put a hold on any data or analysis for which quality control measures are compromised.

3. Review and revise QA/QC procedures as necessary. This includes review and approval of changes or new procedures, and annual review of the QA plan.

4. Coordinate participation in annual performance evaluation studies required to maintain certification and review results with Section Managers and the Laboratory Director.

5. Review and approve initial demonstration of proficiency of new analyses and analysts.

6. Act as a liaison for exchange and release of QA/QC information.

7. Periodically review data packages for correctness and completeness of QA/QC.

8. Act as a liaison between client and lab in technical and QC issues.

9. Maintain an awareness of the laboratory and client feedback sufficient to continually improve quality.

C. The Section Managers Will:

1. Advise the QAQC Officer on quality assurance practices.

2. Provide direction to the analysts and technicians in the section.

3. Define experience, skills, and education requirements for positions in their department.

4. Review all data and quality control generated in his or her department.

5. Work with the QA/QC officer to insure the effective implementation of quality control.

6. Be responsible for resolving any out-of-control event in the section and assure that data generated while the system is out-of-control is flagged or reanalyzed.

7. Maintain an awareness of the entire section to detect any situation which could compromise the safety of any employee.

8. Be responsible for keeping instrumentation in working order, and for documenting instrument problems and corrective action taken.

9. Ensure that department personnel have completed demonstrations of capability.

10. Keep personnel training current.

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Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

2. Organization and Responsibilties

D. Field Sampling Personnel Will:

1. Be trained and certified in proper sampling, testing, and hazardous materials techniques.

2. Maintain, in ink, complete and accurate chain of custody records and field log books.

3. Insure that samples are properly preserved, packaged and transported.

E. Sample Control Personnel Will:

1. Check sample conditions and notify the client of any problems.

2. Accurately enter chain of custody information into the laboratory information management system (LIMS).

3. Properly label samples with LIMS sample numbers.

4. Be responsible for sending samples to proper subcontractor labs when necessary.

5. Release samples to the appropriate section for analysis.

6. Prepare and review client reports.

7. Upload client data as requested to meet regulatory and database requirements.

F. Technical Personnel will:

1. Be trained for all procedures and analyses they run.

2. Maintain a record of all work, including quality assurance data.

3. Know the criteria for out-of-control events, alert the Section Manager when they occur, and attempt to resolve them.

4. Reanalyze or flag data generated during an out-of control situation.

5. Perform and document routine preventive maintenance on the instruments he or she uses.

6. Inform the section manager of any instrument problem, and document the problem and any corrective action taken.

7. Work safely in accordance with the safety regulations specified in the laboratory Safety Policy.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

3. Sampling and Sample Management

Sample management QA/QC addresses sampling techniques, the maintenance of a secure chain of custody, and sample handling from collection to disposal. Alpha’s sampling and sample handling protocols are established using the specifications given in the method appropriate to each analysis. References for these methods are in Section 4.1.

3.1 Collection of Samples

1. The sampling objective is to obtain samples which represent the matrix being tested. Trace levels of contaminants from external sources must be eliminated through the use of good sampling techniques and clean sample containers.

2. Field samples are uniquely identified by client, site, date and time sampled, and identifications provided by site maps. Soil samples may be further identified by borehole depth. See Attachment B for sample field sheet.

3. Trip blanks for volatiles analysis sampling are determined to be free of contamination before leaving the lab.

4. The specific sampling procedures required by each method are described in Field Services SOPs.

The Field Services Manager instructs samplers in each sampling technique.

5. Samplers maintain a field log, in ink, of sampling date, time, location, sample type, and any unusual details with regard to the job. Sample containers are marked to indicate sampling date, time, and location. Samplers will also begin a chain of custody record for each sample. See Attachment C for sample chain of custody.

3.2 Handling of Samples

1. Samples received at the counter are checked for:

A. Temperature
B. Container labels matching chain of custody
C. Completeness of chain of custody
D. Proper containers
E. Proper preservation labels
F. No headspace in volatiles containers.

2. When samples are picked up by our couriers, the courier will:

A. Check that samples and chain of custody agree
B. Sign and date the chain of custody receiving the samples C. Check and record cooler temperature upon returning to Alpha D. Sign and date the chain of custody relinquishing the samples to Alpha E. If samples are received after hours, sign the chain of custody receiving the samples for Alpha

3. When samples are received from delivery services, shipping personnel will:

A. Check and record cooler temperature
B. Bring the cooler to the office to complete the chain of custody requirements This document for management system review only.

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Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

3. Sampling and Sample Management

4. The client is notified if samples do not meet acceptance criteria. Abnormalities are documented, as is all correspondence with the client. If the client decides to proceed with analysis, notes are made on the chain of custody which is included with the final report.

5. Samples sent for subcontracting will be:

A. Accompanied by a signed chain of custody
B. Carefully packed with adequate ice
C. Shipped overnight on Monday through Thursday only

3.3 Sample Containers

1. Sample containers and preparation of such containers will be in accordance with the specifications given in the appropriate analytical methods. Sample containers, preservation and holding times are listed in Attachment D.

2. VOA vials and coliform bottles are purchased pre-preserved in several case lots. Containers from each lot are analyzed for contamination before being distributed to clients. Records of these analyses are logged into the LIMS.

3. Precleaned containers are certified by the manufacturer to be free of contaminants

3.4 Preservation of Samples

1. To prevent or retard the degradation and modification of analytes in samples during transit and storage, the samples are preserved and stored as outlined in the appropriate analytical method or as promulgated in the Federal Register.

2. Sample preservatives are analyzed and determined to be free of contamination before use in samples.

3. Sample preservation requirements are posted in the LIMS, and in this document.

4. Samples are checked for proper preservation at the prep bench. Results are recorded and the client notified when requirements are not met.

3.5 Sample Management

1. Laboratory Numbers - Sample Control Personnel will assign LIMS generated internal laboratory identification numbers to all incoming samples. Unique laboratory numbers are assigned to each sample by date, chain of custody batch, and chain of custody order. For example, sample 19A0010-03 refers to the third listed sample on the tenth chain of custody logged in January 2019. 2 Sample Retention - Samples will be retained for 30 days from receipt unless other arrangements are made.

3. Sample Storage – When samples do not require refrigeration, they are shelved in the inorganics laboratory. Samples requiring refrigeration are stored in the laboratory walk-in or semivolatiles organics refrigerator until all analyses are complete, with the following exceptions.

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Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

3. Sampling and Sample Management

A. Drinking water samples for haloacetic acids, and volatiles analyses are stored in designated drinking water refrigerators.

B. Wastewater samples for volatiles analysis are stored in a designated wastewater refrigerator.

C. Solid samples for volatiles analysis are stored in a designated soils refrigerator.

Cold storage areas are monitored daily. Acceptable ranges are 0 - 6 deg C for refrigerators and ≤0 deg C for freezers. Once analyses are complete, any remaining sample is removed to ambient storage until disposal.

4. Sample Tracking - Sample tracking is accomplished through the LIMS. Sample status is checked throughout the day by appropriate personnel to determine hold times, due dates, and reportability of samples.

5. Sample and Hazardous Waste Disposal - Laboratory waste is collected and held in our hazardous waste storage facility. Hazardous waste is stored in DOT approved containers and commercially disposed of by a California certified waste disposal company as mandated by the California Code of Regulations Title 22.

6. Compliance With Local Regulations - Local city and county regulations pertaining to waste disposal and environmental pollution are strictly adhered to.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

4. Analysis and Calibration

4.1 Analytical Methods

1. An analytical method is a series of procedures or steps that must be performed to estimate the quantity of analyte in a sample

2. Standard and accepted methods are used for each analysis. The methods used are drawn from:

A. Federal Register 40 CFR Parts 136, 260, 423, 430, and 435: Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act; Analysis and Sampling Procedures; USEPA August 28, 2017
B. California Code of Regulations Title 22, Division 4.5, Chapter 11 C. Analytical Methods Approved for Drinking Water Compliance Monitoring of Organic Contaminants; USEPA, September 2016
D. Analytical Methods Approved for Drinking Water Compliance Monitoring of Inorganic Contaminants and Other Inorganic Constituents; USEPA, September 2016 E. Analytical Methods Approved for Drinking Water Compliance Monitoring of Radionuclides; USEPA, September 2016
F. Analytical Methods Approved for Drinking Water Compliance Monitoring Under the Revised Total Coliform Rule; USEPA, February 2017
G. Analytical Methods Approved for Drinking Water Compliance Monitoring Under the Disinfection Byproducts Rule; USEPA, September 2016
H. Analytical Methods Approved for Drinking Water Compliance Monitoring Under the Long Term 2 Enhanced Surface Water Treatment Rule; USEPA, February 2017 I. Leaking Underground Fuel Tank Field Manual: Guidelines for Site Assessment, Cleanup, and Underground Storage Tank Closure; October 1989
J. Analytical Methods Approved for Compliance Monitoring Under the Ground Water Rule; USEPA, February 2017
K. Analytical Methods Recommended for Drinking Water Compliance Monitoring of Secondary Contaminants; USEPA, September 2016
L. Analytical Methods Approved for Compliance Monitoring Under the Surface WAter Treatm3ent Coliform Rule; USEPA, February 2017

3. Standard Operating Procedures (SOP) - SOPs are a step by step listing of procedures used by Alpha for sample analysis. SOPs contain a summary of the method, interferences, instrument parameters, reagents, standards, preservation and special handling, procedure, quality control, calculations, method performance, general maintenance, safety and references. SOPs are continuously reviewed and modified as necessary. Attachment E is a list of current SOPs.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

4. Analysis and Calibration

4.2 Method Detection and Practical Quantitation Limits (MDLs and PQLs)

1. An MDL is defined as the minimum concentration of a substance that can be identified, measured, and reported with 99% confidence that the analyte concentration is greater than zero. MDLs are method and matrix specific. MDL studies are performed following the EPA procedure in 40 CFR Appendix B to Part 136 “Definition and Procedure for the Determination of the Method Detection Limit - Revision 2". This method consists of processing at least seven replicate method standards, generally spiked at three to five times the expected MDL, through the entire analytical method.

The MDL is calculated by multiplying the standard deviation by the applicable t value. MDLs must always be less than or equal to the laboratory PQL. MDL studies are on file for accredited analytes and methods.

2. MDLs are verified annually as described in 40 CFR Part 136 Appendix B.

3. A PQL is the lowest concentration that can be reliably achieved within specified limits of precision and accuracy during routine laboratory operating conditions. For methods employing a calibration curve, the PQL must be at or above the lowest calibration point. Sample PQLs are highly matrix dependent.

4. Nominal PQLs for analytes and methods are listed in Attachment F: Practical Quantitation Limits.

4.3 Calibration
All calibration standards and second source analytes are mixed from pure standard materials or obtained as certified solutions. Lot numbers, dates, and suppliers of analytical standards are recorded in the LIMS. Calibration procedures for specific instruments are described below. Major analytical instruments are listed in Attachment E.

1. Gas Chromatographs (GC) and GC Mass Spectrometers (GCMS) GC and GCMS analyses are performed using either internal or external standard calibration.

Calibration curves are generated at least three concentration levels of standards, with the lowest standard at or below the reporting limit. A second source calibration verification is prepared when required by the method. Calibration curves, second source calibration verification checks, daily calibration checks, and continuing calibration checks must be within method defined limits for analysis to proceed. GCs and GCMSs are recalibrated when the daily calibration check fails.

2. High Performance Liquid Chromatographs (HPLC)
The HPLC uses external or internal calibration with five standards, with the lowest standard at or below the reporting limit. Daily calibration checks must be within method defined limits. HPLCs are recalibrated when the daily calibration check fails.

3. Inductively Coupled Plasma (ICP)
The ICP atomic emission spectrometer is calibrated daily with a blank and two standards. The standard and blank are rerun immediately after calibration. The standard must be within 5% of the expected value and the blank below the PQL for analysis to proceed. A standard prepared from a separate source is analyzed. Response must be within 10% of the expected value for analysis to proceed. The calibration is verified every ten runs and must respond within 10% of the expected value. An ICP Interference Check Standard is run at the beginning and end of each day’s queue.

4. Inductively Coupled Plasma/Mass Spectrometer (ICPMS) This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

4. Analysis and Calibration

The ICPMS is calibrated daily. An initial calibration blank and verification (ICB and ICV) are analyzed immediately after calibration. The ICB must be ≤2.2 times the method detection limit and the ICV within 10% of the expected value for analysis to proceed. A continuing calibration blank and verification (CCB and CCV) are analyzed every ten runs and have the same requirements as the ICB and ICV.

5. Spectrophotometers
Spectrophotometers are calibrated daily, using a blank and two to five calibration standards.

Correlation coefficient must be 0.995 or higher. The calibration is verified every ten readings and at the end of each run with a blank and mid-level standard. Response must be ±10% of expected.

Spectrophotometer wavelengths are verified yearly against traceable standards.

6. pH Meters
pH meters are calibrated daily, using buffer solutions of pH 4, pH 7, and pH 10. A QC check at pH

6.86 is analyzed daily and must be within 0.06 pH units of the expected value. 7 Ion Chromatograph (IC)
A three to five point calibration curve with a correlation coefficient ≥0.995 and a second source calibration verification within method defined limits are needed to begin IC analysis. Analyte response in the initial and final calibration checks must be within method defined limits.

Continuing calibration checks and blanks are run every ten samples and at the end of the run.

Instrument response must be within method defined limits.

8. Miscellaneous Equipment
The Section Managers ensure the daily monitoring of temperatures of all refrigerators, freezers, incubators, and water baths. Daily calibration checks are performed on analytical balances using S1 weights, with yearly maintenance and calibration by Wine Country Balance. Thermometers are checked yearly against NIST-certified thermometers and correction factors affixed. Mechanical pipets are checked quarterly.

4.4 Confirmation
All single peak analytes detected by gas chromatography are confirmed on a second column.

4.5 Preventive Maintenance
Preventive maintenance schedules are maintained for all major instrumentation.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

5. Internal Quality Control

Internal quality control provides the guidelines to assess and ensure the quality of all data produced.

Background, accuracy, and precision limits are established by applying EPA method acceptance criteria and laboratory generated standards of acceptability. Where criteria are not available, EPA suggested control limits may be used until sufficient data is in place. In addition, internal quality control includes a program for corrective action when control limits are exceeded.

5.1 Blanks

1. A method blank is processed through the same preparation and analytical procedures as client samples. Method blanks are matrix specific: separate reagent blanks must be prepared for soil and water samples. Before processing any sample, the analyst will demonstrate through the analysis of a method blank that interferences from the system, glassware and reagents are under control. At least one method blank is analyzed per preparation batch, or as required by the analytical method. Method blanks are not applicable for some methods, such as pH and conductivity.

2. Trip blanks are provided at client request. A trip blank is a VOA sample vial filled in the volatiles laboratory with reagent water. It accompanies sample vials to the sampling site and is subjected to the same ambient conditions as the samples. Trip blanks are prepared only for volatiles analysis and are used to check for possible contamination during sampling, transport, and storage.

3. Field blanks can provide an indication of possible interferences introduced in the field. They are sampled and analyzed at client request.

5.2 Laboratory Control Samples

1. A laboratory control sample (LCS) is a representative, clean matrix spiked with the analytes of interest for the analysis. The LCS is spiked at a concentration within the system’s calibration range.

2. An LCS is prepared with each analytical batch of up to twenty samples, or as required by the method. If the LCS result for any analyte is not within established control limits, the system performance is unacceptable for that analyte, with the following exception: if the recovery exceeds the upper acceptance limits of the method, results for samples without detections may be qualified and reported. Otherwise, the source of contamination must be found and corrected and the associated samples reanalyzed or the results reported with a qualifier.

5.3 Matrix Spike/Matrix Spike Duplicates

1. Matrix spike and matrix spike duplicate (MS/MSD) are prepared from client samples representative of the matrix under analysis. The MS/MSD are spiked at a concentration within the system’s calibration range. If adequate client sample is unavailable, a sample duplicate or duplicate LCS may be prepared.

2. An MS/MSD is analyzed each twenty samples, or as required by the method. If the MS/MSD results are out of control, acceptable LCS results assure that the system is in control, and the former results are generally considered to be due to matrix effects and results qualified.

5.3 Sample Duplicates
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5. Internal Quality Control

1. Sample duplicate analyses are performed when a method is not amenable to spiking, or when a method specifically requires the analysis of unspiked duplicates. The former includes dissolved oxygen, alkalinity, pH, and turbidity analyses. Sample duplicates provide matrix specific information on sample homogeneity and laboratory precision.

5.4 Surrogates

1. Surrogates are chemicals similar to the compounds of interest in a particular analysis, but not usually found in samples. In methods which require their use, they are added to all blanks, calibration standards, samples, and spikes.

2. If method blank or LCS surrogate recovery is out of control, samples generally may not be analyzed until the source of the problem is determined and corrected. If sample surrogate recovery is out of control, the sample is re-prepared and reanalyzed if more is available. If the second analysis is also out of control, or if no more sample is available, the appropriate out-ofcontrol surrogate recovery flag is added to the data.

5.5 Control Limits

1. Accuracy is defined as the degree to which the analytical measurement reflects the true concentration of the analyte present in the sample. Unless accuracy requirements are provided by the method, control limits are established using the results from at least 20 spike recoveries. The mean and standard deviation (s) of the recoveries are calculated and control limits are given by the mean ± 3s. The same procedure is used to set control limits for surrogates.

2. Precision is defined as the degree of agreement between separate measurements of the same analyte in the same sample. Precision control limits are established using the results from at least 15 pairs of MS/MSD, sample duplicates, or duplicate LCSs. The average relative percent difference (RPD) and standard deviation (s) of the duplicates are calculated and a control limit given by the RPD ± 3s.

3. Until the analyst has run enough analyses to generate control limits based on spike recoveries and RPD, the limits used to determine whether or not an analytical system is in control are those given by the method. If no such limits are recommended, spike recovery of 70-130% and RPD between duplicate samples or spikes of 20% or less is generally expected.

4. When a control limit is exceeded, the LIMS red-flags the failed analyte. The problem must be addressed before data can be reviewed. See 5.7 Corrective Action Procedures below.

5.6 Control Charts
Control charts are created by the LIMS and used to monitor the variations in accuracy or precision of routine analyses and can detect trends in these variations. Accuracy control charts are constructed from spike recovery concentrations expressed as a percent of the spiked values. Precision control charts are constructed from the RPD between recovery values for duplicate samples or duplicate spiked samples.

5.7 Corrective Action Procedures
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5. Internal Quality Control

1. Whenever a system is determined to be out of control, corrective steps are taken to bring the system back under control. Corrective actions may involve preparation of fresh standards or reagents, instrument repair, re-analysis, re-extraction, matrix modifications, and dilutions.

2. Analyses will not continue until the system is determined to be under control.

3. Corrective actions can be initiated at several operational levels. First the situation is assessed and appropriate action is taken to correct the situation. The seriousness of the problem will dictate whether corrective actions will be taken at the laboratory personnel level, the department level, or involve the entire laboratory.

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Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.01
October 2019

6. Data Reduction, Validation, and Reporting

6.1 Laboratory Notebooks
When an instrument generated record is not created, data will be entered directly, in ink, into a permanently bound notebook or pre-printed worksheet. The date, method, QC, and sample results will be noted with each analysis, along with any calculations. Errors will be crossed out with a single line, initialed and dated.

6.2 Validation and Reporting of Data

1. The analyst will enter results into the LIMS in the appropriate units, either manually or directly from the analytical instrument, along with initials, instrument, and preparation and analysis dates.

Preparation data and, in some cases, analytical data is entered into the appropriate laboratory notebook.

2. The Section or Quality Managers will review all QC results and corrective action procedures prior to sending data to Sample Control for reporting. Such approval will be indicated by setting analytical results to "Reviewed" in the LIMS.

3. Sample Control Personnel will generate final written reports.

4. Validation of the final report by approved Laboratory Control Personnel will consist of seeing that the following requirements are met:
a) Sample receiving, extraction and holding times, and batch QA/QC requirements must be met or flagged.
b) Printed analytical reports will contain a unique lab number for each sample. Each target analyte prepared in the Alpha network will be associated with a result, concentration unit, method used, reporting limit, and ELAP certificate number of the analyzing lab. The report will also include the original of any report prepared by all other laboratories outside the Alpha network.
c) Final, validated analytical results shall be accompanied by the appropriate Chain-OfCustody documents, and a batch specific QA/QC report if requested.

6.3 Backing Up and Archiving LIMS Data
The file server containing all LIMS data is backed up at the end of every business day to a dedicated hard drive. A complete backup is created weekly and stored off-site. All written reports, lab sheets and other related paper are stored for at least five years.

6.4 Quality Control Reports
Quality control reports will be issued upon client request and will consist of a separate batch specific report with method blank, duplicate, laboratory control samples (blank spikes), and/or matrix spike results. The method blank is reported in the same units of concentration as the matrix or "ND". Spike results are reported in the same units of concentration as the matrix and as percent recoveries of the analytes. The relative percent difference (RPD) is reported to indicate precision in terms of the difference between percent recoveries of duplicates and duplicate spikes.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

7. Safety

Our company will, at all times and at every level of management and supervision, attempt to provide and maintain a safe working environment for all of our employees. In addition, all safety policies will be prevention oriented in the hope that all preventable accidents can and will be avoided. The company will also make every effort to stimulate employee participation in the program so that safety maintenance methods may be used most effectively. This should help eliminate any possible repetition of accidents.

7.1 Policy Goals

1. To provide and maintain an injury free working environment.

2. To solve safety problems through prevention and investigation.

3. To promote safety consciousness of both management and employees through education and mutual participation.

4. To reduce injury related absenteeism when the problem exists.

5. To establish the best line of communication between management and employees in all safety areas.

6. To use authority to decrease safety violations.

7.2 Organization
The Safety Committee meets quarterly to discuss safety concerns and policy and to make recommendations to management. The committee is comprised of non-supervisorial employees from each laboratory section. The committee will be co-chaired by the Chemical Hygiene Officer and one of the company owners.

7.3 Chemical Hygiene Plan
The complete Safety Policy and Chemical Hygiene Plan is on file with the Chemical Hygiene Officer.

7.4 Emergency Action Plan
The Emergency Action Plan - for an explosion, fire, or other emergency requiring immediate evacuation is on file with the Chemical Hygiene Officer.

7.5 Material Safety Data Sheets (MSDSs)
MSDSs for all chemicals used in the organics section are located in the GC room. Additional MSDSs are located in the Conference Room.

7.6 Safety Training
Safety training is provided to employees when hired and in yearly refresher courses.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment A
Ethics and Integrity Policy and Data Integrity Agreement

1.1 Alpha Analytical Laboratories Ethics and Data Integrity Agreement Introduction and Policy
This information is in support of our policy of data integrity and business ethics at Alpha Analytical Laboratories. This accompanies our Ethics and Integrity Agreement which all lab employees must understand and agree to as part of working at Alpha Analytical Laboratories.

Alpha Analytical Laboratories’ clients use our analyses for numerous purposes. Most of those purposes include some type of regulatory compliance. Some results are used to determine cleanup of various waste sites. It is therefore of utmost importance that we are ethical in all of our dealings with our clients and in carrying out and reporting the results of the analysis we perform. Unethical behavior includes falsifying records, reporting data values that are not the actual values obtained, reporting dates and times of analysis that are not correct, and any intentional misrepresentation of the data or reporting of the data. Lab fraud involves any of the above unethical behaviors, and is characterized by intent to deceive. We want to never authorize, approve, accept, or imply an acceptance of any behavior or practice that includes intent to deceive.

If a hold time is missed, record that accurately. If a laboratory control sample fails, record that accurately. Etc.

Violations of this standard are subject to corrective action up to and including termination from the company. If an act or series of actions are believed to be errors, or misunderstandings, further training and clarification will be provided, and communicated among the employees of the area. Employees convicted of laboratory fraud may be individually subject to criminal and civil penalties.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment A
Ethics and Integrity Policy and Data Integrity Agreement

1.1 Alpha Analytical Laboratories Ethics and Data Integrity Agreement (cont)

1.1.1 I understand the high standards of integrity required of me with regard to the duties I perform and the data I report in connection with my employment at Alpha Analytical Laboratories.

1.1.2 I agree that in the performance of my duties at Alpha Analytical Laboratories, I shall not intentionally report data values that are not the actual values obtained; a. I shall not intentionally report dates and times of data analyses that are not actual dates and times of analyses, and
b. I shall not intentionally represent another individual’s work as my own.

1.1.3 I agree to inform Alpha Analytical Laboratories of any accidental reporting of nonauthentic data by myself in a timely manner.

1.1.4 I agree to inform Alpha Analytical Laboratories of any accidental or intentional reporting of non-authentic reporting by other employees.

1.1.5 I agree to not promote, engage in, or condone any practice that is intended to deceive my co-workers or Alpha Analytical Laboratories’ clients with regard to the quality of data produced or reported.
(Printed Name)
(Signature)
(Date)
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Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment B
Field Sheet

This document for management system review only.

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February 2019

8. Attachments
Attachment C
Chain of Custody

This document for management system review only.

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Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment C
Chain of Custody

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Microbiological Analyses
Samples are collected in 100 ml sterile containers containing sodium thiosulfate (Na2S2O3) sufficient to neutralize at least 15 mg/L residual chlorine. Where preservation is “None”, EPA recommends but does not require <10 deg C. TC = total coliform, FC = fecal coliform, EC = e. coli.

Analysis Method Preservation Holding Time
Coliform: Presence/absence TCEC
Revised Total Coliform Rule
SM9221B,F
SM9223B None 30 hours
Coliform: Enumeration EC
LT2 Enhanced Surface Water Treatment Rule SM9223B Colilert 0-10 deg C 30 hours Coliform: Enumeration EC
Groundwater Rule SM9223B Colilert None 30 hours
Coliform: Enumeration TC
Surface Water Treatment Rule
SM9221A,B,C
SM9223B Colilert <10 deg C 8 hours
Coliform: Enumeration FC
Surface Water Treatment Rule SM9221B,C,E <10 deg C 8 hours Coliform: Enumeration TC
40 CFR Part 136 Table II SM9221B, <10 deg C 8 hours
Coliform: Enumeration FC
40 CFR Part 136 Table II SM9221C,E <10 deg C 8 hours
Coliform: Enumeration EC
40 CFR Part 136 Table II SM9223B Colilert <10 deg C 8 hours Enterococci Enterolert <10 deg C 8 hours
Heterotrophic Bacteria (Surface Water Treatment Rule) SM9215B Simplate <10 deg C 8 hours
Heterotrophic Bacteria (Not regulated) SM9215B
Simplate <4 deg C 24 hours
Whole Effluent Toxicity of Wastewater
Analysis Method Container1 Preservation Holding Time
Freshwater Static Acute: Rainbow Trout FISH 2 x 2.5gal Cubitainer ≤6 deg C 36 hours Toxicity Bioassay of Hazardous Waste
Analysis Method Container1 Preservation Holding Time
LC-50 Aqueous: Fathead Minnow CDFG Pint P, G ≤6 deg C Not specified LC-50 Solid Waste: Fathead Minnow CDFG 8 oz. jar ≤6 deg C Not specified Inorganic and Wet Chemistry: Aqueous Analyses
Analysis Method Container1 Preservation Holding Time
Alkalinity SM2320B Pint P,G ≤6 deg C 14 days
Ammonia SM4500-NH3 B,C Quart P,G Dechlorinate with 80mg/L Na2S2O3 if needed. ≤6 deg C, H2SO4 to pH <2 28 days
Bicarbonate SM2320B Pint P,G ≤6 degC 14 days
BOD and CBOD SM5210B Quart P,G ≤6 degC 48 hours
Bromate EPA300.1 Pint P,G 50 mg/L EDA 28 days
Bromide EPA300.1 Pint P,G None 28 days
This document for management system review only.

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Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Inorganic and Wet Chemistry: Aqueous Analyses (cont.)
Analysis Method Container1 Preservation Holding Time
Carbonate SM2320B Pint P,G ≤6 degC 14 days
Carbon Dioxide, Free SM4500-CO2 B See total dissolved solids; pH; and alkalinity Chloramines SM4500-Cl F Quart brown P,G None 15 minutes Chlorate EPA300.1 Pint P,G 50mg/L EDA 28 days
Chloride EPA300.0 Pint P,G ≤6 degC 28 days
Chlorine, residual SM4500-Cl F Quart brown P,G None 15 minutes Chlorite EPA300.1 1L brown poly ≤6 degC, 50mg/L EDA 14 days Chlorophyll SM10200H 1L brown poly ≤6 degC 48 hours until filtration
COD SM5220D Pint P,G ≤6 degC, H2SO4 to pH <2 28 days
Color SM2120B Pint P,G ≤6 degC 48 hours
Conductivity SM2510B Pint P,G ≤6 degC 28 days
Corrosivity: Langelier Index SM2330B See alkalinity, hardness, pH, and total dissolved solids.

Corrosivity: Aggressive Index AWWA See calcium, alkalinity, and pH.

Cyanide, amenable SM4500-CN G Quart brown P,G ≤6 degC, NaOH to pH >10 14 days Cyanide, reactive SW846 Ch.7, SW9014 Pint brown P,G Cool and dark Not specified Cyanide, total Lachat QuikChem Quart brown P,G
≤6 degC, NaOH to pH >10,
reducing agent if oxidizer is
present
14 days
Fluoride EPA300.0 Pint P,G None 28 days
Hardness SM2340B
EPA200.7 Pint P,G HNO3 to pH <2 6 months
MBAS (surfactants) SM5540C Quart. P,G ≤6 degC 48 hours
Nitrate (NO3
-
) EPA300.0
SM4500-NO3 E Pint P,G ≤6 degC 48 hours
Nitrate + nitrite SM4500-NO3 E Pint. P,G ≤6 degC, H2SO4 to pH <2 28 days Nitrite (NO2
-
) EPA300.0
SM4500-NO2 B Pint P,G ≤6 degC 48 hours
Nitrogen, inorganic See ammonia, nitrate, and nitrite nitrogen.

Nitrogen, Kjeldahl SM4500-NHorg B Quart P,G ≤6 degC, H2SO4 to pH <2 28 days Nitrogen, organic See ammonia and Kjeldahl nitrogen.

Nitrogen, total See nitrate, nitrite, and Kjeldahl nitrogen.

Odor EPA140.1 8oz, glass only ≤6 degC 24 hours
Oil and Grease EPA1664A 2 x 1L amber glass
w/ Teflon cap
≤6 degC, HCl or H2SO4 to
pH <2 28 days
Orthophosphate EPA300.0
SM4500-P E Pint P,G ≤6 degC, filter within 15 min 48 hours Oxygen, dissolved SM4500-O G BOD bottle, no
headspace None 15 minutes
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Inorganic and Wet Chemistry: Aqueous Analyses (cont.)
Analysis Method Container1 Preservation Holding Time
Perchlorate EPA314.0 Pint P,G None 28 days
pH SM4500-H+ B
SW9040 Pint P,G None 15 minutes
Phenolics EPA420.1 1L glass only ≤6deg C, H2SO4 to pH <2 28 days Phosphorus, total SM4500-P E Pint P,G ≤6 deg C, H2SO4 to pH <2 28 days Salinity SM2510B Pint P,G ≤6 deg C 28 days
Silica SM4500-SiO2 C Pint, P only ≤6 deg C 28 days
Sodium adsorption ratio
(SAR) See metals.

SAR, adjusted See metals, bicarbonate, and conductivity.

Solids, total dissolved (TDS) SM2540C 1L P,G ≤6 deg C 7 days Solids, total suspended (TSS) SM2540D 1L P,G ≤6 deg C 7 days Solids, settleable SM2540F 1L P,G ≤6 degC 48 hours
Solids, total SM2540B 1L P,G ≤6 degC 7 days
Solids, fixed and volatile SM2540E Pint P,G ≤6 deg C 7 days Sulfate EPA300.0 Pint P,G ≤6 deg C 28 days
Sulfide SM4500-S F Pint P,G ≤6 deg C, Zn acetate/NaOH
to pH >9 7 days
Sulfide, reactive SW846 Ch.7,
SW9034 1L poly Cool and dark Not specified
Sulfite EPA 300.1 Pint P None 15 minutes
Tannin and lignin SM5550B Pint P,G Not specified Not specified Total or dissolved organic
carbon (TOC/DOC) SM5310C 2 x 40ml amber VOA vial, no headspace ≤6 deg C, H3PO4 to pH <2 28 days Turbidity SM2130B Pint P,G ≤6 deg C 48 hours
UV254 SM5910B 250 ml amber glass ≤6 deg C 28 days
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Inorganic and Wet Chemistry: Soil and Solid Waste Analysis Samples are collected in 8oz jars and kept at ≤6 deg C. Samples for reactive cyanide or sulfide must be stored with no headspace and protected from light.

Analysis Method Holding Time
Ammonia SM4500-NH3 C Not specified
Chloride EPA300.0 Not specified
Cyanide, total SW9010B
SW9014 14 days
Cyanide, reactive SW846 Sect. 7.3 ASAP
Nitrate (NO3) EPA300.0 Not specified
Nitrite (NO2) EPA300.0 Not specified
Nitrogen, Kjeldahl SM4500-NHorg B Not specified
Oil & grease SW9071A Not specified
pH SW9045C ASAP
Solids, total, fixed and volatile SM2540G 7 days
Sulfate EPA300.0 Not specified
Sulfide, reactive SW846 Ch.7, SW9034 ASAP
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Metals: Aqueous Analysis
Analysis Method Container1 Preservation Holding Time
Metals, total
except Cr(VI) and Hg
EPA200 Series
EPA6010B Quart P HNO3 to pH <22 6 months
Metals, dissolved
except Cr(VI) and Hg
EPA200 Series
EPA6010B Quart P HNO3 to pH <2, after filtering2 6 months Hexavalent chromium (Cr(VI)) SW7196A Pint P,G ≤6° deg C 24 hours Hexavalent chromium (Cr(VI))
Drinking Water EPA 218.6 Pint P,G ≤6 deg C , ammonium sulfate buffer 14 days Hexavalent chromium (Cr(VI))
Waste Water
SM3500-Cr B
EPA 218.6 Pint P,G
≤6° deg C , ammonium sulfate
buffer, adjust pH to 9.3 -9.7 within
24 hrs
28 days
Mercury, total EPA245.1
EPA 7470A Pint P,G HNO3 to pH <2 28 days
Mercury, low level EPA 1631E Pint G ≤6° deg C 28 days3
Mercury, dissolved EPA245.1
EPA 7470A Pint P,G HNO3 to pH <2, after filtering 28 days Mercury, methyl EPA 1630 1L amber
glass ≤6 deg C, HCl to pH<2 within 48 hr 180 days
Metals: Soil and Solid Waste Analysis
Analysis Method Container Preservation Holding Time
Metals, except Cr(VI) and Hg SW6010B 8oz. jar None 6 months Mercury, total SW7471A 8oz. jar ≤6 deg C 28 days
TCLP Extractions SW1311
Analyses require an 8oz Teflon-capped jar, or a foil-capped brass or stainless steel cylinder of sample.

Analysis Holding time before leaching Holding time after leaching Metals, except Hg 180 days 180 days
Mercury 28 days 28 days
Volatile organics 14 days 14 days
Semi-volatile organics 14 days 7 days
Extraction Tests for Hazardous Waste
Analyses require an 8oz Teflon-capped jar, or a foil-capped brass or stainless steel cylinder of sample.

Extraction Holding time before extraction Holding time after extraction WET Extraction (Title 22) Not specified See appropriate aqueous analysis This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Organic Chemistry: Drinking Water Analyses
Samples with residual chlorine must be dechlorinated before preservation: 2 drops of 10% sodium thiosulfate solution (3mg sodium thiosulfate) per 40mL VOA vial for volatiles, 1mL (80mg)per liter for semivolatiles. All containers require Telfon lined caps or septa. Volatiles (VOA) vials must contain no headspace.

Analysis Method Container Preservation Holding Time
EDB/DBCP EPA504.1 3 x 40ml VOA vials ≤6 deg C 14 days
N-, P - pesticides EPA507 2 x 1L amber glass ≤6 deg C 14 days Chlorinated pesticides/PCBs EPA508 2 x 1L amber glass ≤6 deg C 7 days Chlorinated acids EPA515.3 2 x 1L amber glass ≤6 deg C. May be dechlorinated with 50mg/L sodium sulfite. 14 days
Trihalomethanes EPA524.2 4 x 40ml VOA vials ≤6°C 14 days Purgeable organic compounds EPA524.2 4 x 40ml VOA vials ≤6 deg C, HCl to pH <2 after dechlorination4 14 days
Benzo(a)pyrene, DEHA, DEHP EPA 525.3 2 x 1L amber glass L-ascorbic acid, EDTA, K
dihydrogen citrate to pH 3.8. ≤6
deg C
14 days
Carbamates EPA531.1 125ml amber glass ≤6 deg C, 3.6ml MCAA5 buffer 28 days Glyphosate EPA547 125ml amber glass ≤6 deg C 14 days
Endothall EPA548.1 250ml amber glass ≤6 deg C 7 days
Diquat, Paraquat EPA549.2 1L brown poly ≤6 degC 7 days
Haloacetic acids EPA552.2 250ml amber glass ≤6 deg C, 100mg/L ammonium chloride, no sodium thiosulfate 14 days
Organic Chemistry: Waste Water Analyses
Samples with residual chlorine must be dechlorinated before preservation, except as noted below: 2 drops of 10% sodium thiosulfate solution (10mg sodium thiosulfate)/ 40mL vial for volatiles, 1mL(80mg)/L for semivolatiles. All containers require Teflon lined caps or septa. Volatiles vials must contain no headspace.

Analysis Method Container Preservation Holding Time
Organochlorine pesticides EPA608 2 x 1L amber glass ≤6 deg C, pH to 5-9 if not extracted within 72 hours 7 days
PCBs EPA608 2 x 1L amber glass ≤6 deg C 1 year
Organophosphorus pesticides EPA614 2 x 1L amber glass ≤6 deg C 7 days Purgeable aromatic compounds EPA624 4 x 40ml VOA vials ≤6 deg C, HCl to pH <2 after dechlorination
14 days preserved,
7 days unpreserved
Purgeable halocarbons EPA624 4 x 40ml VOA vials ≤6 deg C, HCl to pH <2 after dechlorination
14 days preserved,
7 days unpreserved
Acrolein, acrylonitrile EPA624 4 x 40ml VOA vials ≤6 deg C 3 days7 2-Chloroethylvinyl ether EPA624 4 x 40ml VOA vials ≤6 deg C 14 days8 Phenols, benzidines, haloethers,
chlorinated hydrocarbons EPA625 2 x 1L amber glass ≤6 deg C 7 days Phthalate esters, chlorinated
hydrocarbons EPA625 2 x 1L amber glass ≤6 deg C, dechlorination not required 7 days Nitrosoamines, nitroamromates,
isophorone, PNA's EPA625 2 x 1L amber glass ≤6 deg C, store in dark 7 days Pharmaceutical Pollutants EPA 524.2
EPA1666 4 x 40ml VOA vials ≤6 deg C, HCl to pH <2 after dechlorination 14 days This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Organic Chemistry: Aqueous Waste Analyses
Samples with residual chlorine must be dechlorinated before preservation: 2 drops of 10% sodium thiosulfate (10mg sodium thiosulfate)/ 40mL vial for volatiles, 1mL(80mg)/L for semivolatiles. Samples to be analyzed for purgeable non-aromatics do not require acidification. All containers require Teflon lined caps or septa. Volatiles vials must contain no headspace.

Analysis Method Container Preservation Holding Time
TPH: diesel/motor oil range organics SW8015B 2 x 1L amber glass ≤6 deg C 7 days TPH: diesel/motor oil range organics LUFT 2 x 1L amber glass ≤6 deg C 14 days Organochlorine pesticides and PCBs SW8081A
SW8082 2 x 1L amber glass ≤6 deg C 7 days
Organophosphorus pesticides SW8141A 2 x 1L amber glass ≤6 deg C 7 days Phenoxy herbicides SW8151A 2 x 1L amber glass ≤6 deg C 7 days Trichlopyr (Garlon) SW8151A 2 x 1L amber glass ≤6 deg C 7 days TPH: gasoline range organics SW8260B 4 x 40ml VOA vials ≤6 deg C, HCl to pH <2 after dechlorination 14 days
Volatile organic compounds SW8260B 4 x 40ml VOA vials ≤6 deg C, HCl to pH <2 after dechlorination 14 days
Semivolatile organics SW8270C 2 x 1L amber glass ≤6 deg C 7 days Phenols SW8270C 2 x 1L amber glass ≤6 deg C 7 days
PNAs (PAHs) SW8270C 2 x 1L amber glass ≤6 deg C 7 days
Formaldehyde SW8315A 1L amber glass ≤6 deg C 3 days
Organic Chemistry: Soil and Waste Analyses
Analysis Method Container Preservation Holding Time
TPH gasoline range
organics
SW5030B
SW8015B
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar. No headspace.
≤6deg C 14 days
TPH gasoline range
organics
SW5035
SW8015B 3 x Encore samplers ≤6 deg C 48hr to preserve,14 days to analyze Volatile organics SW5030B SW8260B
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar. No headspace.
≤6 deg C 14 days
TPH: diesel range and
semivolatile organics by GC
or GCMS
SW8015M
SW8081A
SW8082
SW8270C
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar
≤6° deg C 14 days
PCBs in oil SW8082 20ml glass vial w/ Teflon cap Unpreserved 14 days This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Subcontracted Organic Drinking Water Analyses
Aqueous samples with residual chlorine must be dechlorinated before preservation: 2 drops of 10% sodium thiosulfate solution (3mg sodium thiosulfate) per 40mL VOA vial for volatiles, 1mL (80mg) per liter for semivolatiles. All containers (except PVC) require Telfon lined caps or septa. Volatiles (VOA) vials must contain no headspace.

Analysis Method Container Preservation Holding Time
Pesticides and PCB's EPA505 125 ml amber glass ≤6 deg C 14 days Perfluorinated alkyl acids EPA 537 500 ml amber poly ≤6 deg C, Trizma 14 days 1,2,3-Trichloropropane EPA524.2M 2 x 40ml VOA vials ≤6 deg C 14 days Nitrosamines EPA521 1L amber glass ≤6 deg C 14 days
Subcontracted Organic Wastewater and Aqueous Hazardous Waste Analyses Aqueous samples with residual chlorine must be dechlorinated before preservation: 2 drops 10% sodium thiosulfate solution (3mg sodium thiosulfate)/40mL vial for volatiles, 1mL (80mg)/Lfor semivolatiles. All containers require Telfon lined caps or septa. Volatiles vials must contain no headspace.

Analysis Method Container Preservation Holding Time
Carbamate and urea pesticides EPA632 1L amber glass ≤6 deg C 7 days Dioxins EPA1613 2 x 1L amber glass ≤6 deg C 1 year
Dioxins SW8290 2 x 1L amber glass ≤6 deg C 30 days
7 Oxygenates SW8260B 2 x 40ml VOA vials ≤6 deg C, 2 drops 1:1 HCl after dechlorination2 14 days
Pharmaceutical pollutants:

Amines, methyl cellosolve EPA1666 2 x 40ml VOA vials ≤6 deg C 7 days Polynuclear aromatics EPA610
SW8310 1L amber glass ≤6 deg C 7 days
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Subcontracted Organic Soil Analyses
Analysis Method Container Preservation Holding Time
Dioxins SW8290
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar. No headspace.
≤6 deg C 30 days
7 Oxygenates SW5030B
SW8260B
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar. No headspace.
≤6 deg C 14 days
7 Oxygenates SW5035
SW8260B 3 x Encore samplers ≤6 deg C 48hr to preserve,14 days to analyze Organophosphorus
pesticides SW8141A
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar. No headspace.
≤6 deg C 14 days
Phenoxy herbicides SW8151A
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar. No headspace.
≤6 deg C 14 days
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

Subcontracted Miscellaneous Analyses
Analysis Method Container Preservation Holding Time
Agricultural suitability Several 8 oz. jar ≤6°C Not specified Asbestos, aqueous EPA100.2 2 x 1L amber glass ≤6 deg C 48 hours9 Asbestos, bulk PLM 15g, double plastic bag Unpreserved Not specified Asbestos, soil CARB435 8 oz. jar Unpreserved 180 days
Gross Alpha
Gross Beta EPA900.0 Quart P HNO3 to pH <2 within 5 days of collection, then hold 16 hours 180 days
preserved
Hexavalent chromium
(Cr(VI)) SW7199 ≤6 deg C ≤6 deg C 30 days
Iron bacteria SM9240B Pint P,G Not specified Not specified Organic lead, aqueous DHS LUFT 3 x 40ml VOA vials, no
headspace ≤6 deg C 14 days
Organic lead, soil DHS LUFT
Foil capped brass or stainless
steel cylinder or 4 oz. Teflon
capped jar. No headspace.
≤6 deg C 14 days
Radium 226 adn 228 EPA903 Quart P HNO3 to pH <2 within 5 days of collection, then hold 16 hours 180 days
Radon SM7500Rn 40ml VOA Unpreserved 4 days
Strontium 90 EPA905 Quart P ≤6 deg C, HNO3 to pH <2 180 days Tributyltin Battelle 1L glass amber ≤6 deg C 7 days
Tritium EPA 906 1L glass amber ≤6 deg C 180 days
Uranium EPA 908
EPA 908.1 Quart P Unpreserved 180 days
1 Plastic (P) or glass (G)
2 Samples not preserved in the field must be acidified at least 24 hours prior to analysis. 3 Sample digested in container with bromine monochloride. 4 EPA recommends dechlorinating with 25mg ascorbic acid per 40ml VOA vial for the full 524.2 list. 5 Monochloroacetic acid.
6 May be analyzed from acidified vial.
7 Holding time is 14 days if pH adjusted to 4-5 at collection. 8 May not be analyzed from acidified vial. 9
Asbestos TEM Laboratory can treat asbestos samples with UV as described in Section 8.2 of EPA 100.2 to extend the hold time.

Method Sources and Abbreviations
Hold times specified in the Method Update Rule (Federal Register, 40 CFR Part 136, May 18, 2012) supercede times given in other sources where applicable.

AWWA “American Waterworks Association Standard for Asbestos-Cement Pipe, 4 inch through 16 inch (100mm through 400mm) NPS, for Water and Other Liquids.” AWWA C400-80, Revision of C400-77, AWWA, Denver Colorado; June 1980 CDFG Static Acute Bioassay Procedures for Hazardous Waste Samples, Polsini and Miller, California Department of Fish and Game; November 1988.

CPAR Effect of Pulp Chlorination Conditions on the Formation of Toxic Chlorinated Compounds, Pulp and Paper Research Institute of Canada, Final Report to March 31, 1979
Method Sources and Abbreviations (continued)
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment D
Sample Containers, Preservation, and Holding Times

FISH Methods for Measuring the Acute Toxicity of Effluents to Freshwater and Marine Organisms; Fifth Edition; EPA-821-R-02- 012; Washington, DC, October 2002
DHS LUFT Leaking Underground Fuel Tank Field Manual: Guidelines for Site Assessment, Cleanup, and Underground Storage Tank Closure; October 1989
RSK-175 Technical Guidance for the Natural Attenuation Indicators: Methane, Ethane, and Ethene, USEPA Region 1, February 21, 2002
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Administrative SOPs (ADMINSOP)
ADMINSOP1.00 EBackup 1.00 2017 Dec Backing Up of Electronic Records Field Services SOPs (FSOP)
FSOP2.00 Groundwater 1.04 2013 May Field Guide and SOP for Ground Water Monitoring FSOP2.01 CreekSampling 1.01 2016 Jul Field Guide and SOP for Spring or Creek Sampling FSOP2.02 PotBactiSamp 1.02 2017 Jan Potable Water Bacteriological Field Sampling FSOP4.00 TCpH 2.01 2017 Oct Calibration of Field Temperature/Conductivity/pH Meter FSOP4.01 DO 2.01 2017 Oct Field Measurement of Dissolved Oxygen FSOP4.02 FieldpH 1.01 2106 Jul Field pH instrument Calibration, Sample Collection, and Analysis FSOP4.04 FieldTurbidity 2.00 2017 Oct Measurement of Turbidity in the Field FSOP4.05 FieldTestCoC 1.00 2014 Aug Field Testing Chain of Custody FSOP5.00 VOADechlor 2.02 2016 Jun Dechlorinating and Preserving Samples for Volatiles Analysis FSOP5.02 AscorbicAcid 1.02 2016 Jun Collecting Chlorinated Samples for EPA 524.2 Analysis FSOP7.00 NonPotable 1.01 2017 May Non-Potable Field Sampling and Collection Guidelines This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Inorganics SOPs (ISOP)
ISOP1.02.01 01 Hg-Aq 4.03 2018 Nov Digestion and Analysis of Mercury in Water by EPA Method 245.1/7470 ISOP1.02.02 02 Hg-So 3.02 2018 Nov Digestion and Analysis of Mercury in Soils and Sludges by EPA Method 7471 ISOP1.03 ICP 3.00 2018 Jan Trace Metal Analysis by Inductively Coupled Plasma (ICP) ISOP1.04 TOC 4.00 2017 Nov Analysis of Total Organic Carbon (TOC) and Dissolved Organic Carbon (DOC) ISOP1.06 Cr6 2.00 2016 Jun Analysis of Hexavalent Chromium by EPA Method 7196A ISOP1.07 TKN 2.01 2018 Aug Analysis of Total Kjeldahl Nitrogen ISOP1.08 P&PO4 4.00 2019 Jan Analysis of Total Phosphorus, Total Phosphate, and Orthophosphate in Water ISOP1.09 Ign 2.00 2016 Jun Ignitability
ISOP1.10 Color 2.01 2018 Jul Determination of Color
ISOP1.11 AgIDX 2.00 2016 Jun Aggressive Index Calculation ISOP1.12 Lang 2.00 2013 Apr Langelier Index Calculation ISOP1.13 Salinity 3.00 2016 Apr Salinity in Water Calculation ISOP1.14 SAR 3.00 2018 Feb SAR and Adjusted SAR Calculation ISOP1.15 Hardness 1.02 2018 Jul Hardness: Total, Calcium, and Magnesium ISOP1.16 Cr3 2.00 2016 Jun Chromium (III) Calculation
ISOP1.17 Odor 2.04 2018 Jul Determination of Odor
ISOP1.18 HvyMtlCalc 2.00 2016 Jun Heavy Metals Calculation ISOP1.19 Cations 1.03 2018 Feb Total Cations
ISOP1.20 ACBalance 1.02 2018 Feb Anion/Cation Balance
ISOP1.21 ICPMS 4.00 2018 Nov Trace Metal Analysis by ICPMS ISOP2.01 AcidDigest 2.03 2018 Oct Acid Digestion for Metals ISOP2.03 3015 3.02 2018 Jan Microwave Digestion of Aqueous Samples by EPA Method 3015 ISOP2.04 3051 3.01 2018 Jan Microwave Digestion of Soil, Oil, and Solid Waste by EPA Method 3051 ISOP2.06 Diss 1.04 2018 Oct Dissolved Metals Prep
ISOP2.08 STLC 2.02 2018 Oct STLC WET Extraction
ISOP2.09 200.8 Prep 2.00 2018 Dec EPA Method 200.8 Sample Preparation ISOP2.10 Batching 2.01 2018 Dec Batching Samples for ICP, ICPMS, and GFAA ISOP2.11 Larson-Skold 2.00 2018 Feb Larson-Skold Index
ISOP2.12 Labware 1.02 2019 Jan Metals Glassware
ISOP2.13 7471M Digest 2.00 2018 Oct Sulfur Cake Digestion for Mercury by EPA 7471M ISOP2.14 TCLP 1.01 2018 Oct TCLP Extraction for Inorganic Analytes IDOP2.15 DI Tanks 1.00 2019 Jan Changing the DI Tanks
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Laboratory SOPs (LABSOP)
LABSOP1.01 Thermo 2.05 2017 May Thermometer Calibration LABSOP1.02 Pipet 3.00 2014 Jan Pipetter Calibration and Maintenance LABSOP1.03 Spectronic 2.01 2018 Fewb Spectrophotometer Wavelength Verification LABSOP1.04 Doc Control 2.00 2017May Document Control SOP LABSOP1.05 Balance 1.02 2016 Dec Analytical Balance
LABSOP1.06 LODLOQ 1.011 2016 Jun LOD and LOQ Verification LABSOP1.07 PTs 2.00 2017 May Analysis and Reporting of PT Samples LABSOP1.08 Data Pkg 1.00 2016 Aug Data Package for Initial Method Demonstration LABSOP1.09 MDL 1.00 2018 Aug Establishing Method Detection Limits LABSOP1.10 Training Doc 1.01 2017 Feb Training Documentation LABSOP1.11 NCCA 1.00 2017 Jan Documentation of Non-Compliance and Corrective Action LABSOP1.12 Data Review 1.00 2016 Dec Data Review Checklist LABSOP1.13 Purchasing 1.00 DRAFT Purchasing: Approvals and Records LABSOP1.14 Reagent Rec 1.00 2018 Aug Receiving Purchased Reagents LABSOP1.15 Reagent Lab 1.00 2017 Jul DRAFT Laboratory Logging of Purchased Reagents LABSOP1.16 Reagent Prep 1.00 2018 Aug Entering Prepared Reagents into Element LABSOP1.17 Std Login 1.00 2017 Aug DRAFT Logging of Standards LABSOP1.18 Pipetting 1.00 2017 Aug Pipetting Tips and Techniques LABSOP1.19 DR2800 1.00 2018 Feb DR 2800 Wavelength Verification LABSOP1.20 Calibration 1.00 2018 Mar DRAFT Initial Calibration (TNI) LABSOP1.21 Balance Check 1.00 2018 May Balance Checks
LABSOP1.22 Volume Check 1.00 2018 Sep Volume Checks
LABSOP1.23 Lab SOPs 1.00 2019 Feb Laboratory SOPs
LABSOP2.00 Data Monitoring 1.00 2017 Dec DRAFT Monitoring of Data Integrity LABSOP2.01 DII & R 1.00 2018 Aug Data Integrity Investigation and Recall Guidance LABSOP2.02 Calc Validation 1.00 2018 Feb Validating Spreadsheets This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Microbiology SOPs (MSOP)
MSOP1.00 Autoclave 2.00 2019 Jan Autoclave Sterility Test MSOP1.01 Coli Bottle 2.00 2018 Aug Coli Bottle Check
MSOP1.02 ColiWash 3.00 2018 Aug Coli Wash (Dilution Water) Preparation MSOP1.03 Controls 1.04 2018 Apr Preparation of Positive and Negative Coliform Controls MSOP1.04 TSB 1.02 2018 Aug Tryptic Soy Broth
MSOP1.05 MicroPrep 1.03 2018 Aug Preparing Aqueous Microbiological Samples MSOP1.06 MicroDisp 1.01 2018 Aug Disposal of Microbiological Samples MSOP1.07 Pipets 2.01 2018 Aug Micropipet and Dispenser Verification MSOP1.08 Quantitray Check 1.00 2018 May Quantitray Sterility Check MSOP2.00 PA 2.00 2017 Jun Presence/Absence of Total and E. coli in Drinking Water by SM9223 MSOP2.01 TCFC15 2.05 2017 Apr Total and Fecal Coliforms: Most Probable Number (MPN) 15 Tube by SM9221 MSOP2.02 TCFC10 1.05 2016 June Total and Fecal Coliforms: Most Probable Number (MPN) 10 Tube by SM9221 MSOP2.03 Media 1.05 2017 May Media Preparation for Microbiology MSOP2.04 QuantiTray 2.01 2017 Jun Total and Fecal Coliforms in Drinking Water by SM9223 QuantiTray MSOP2.05 Coli HiDil 2.03 2019 Jun High-Dilution Total and Fecal Coliforms by SM9221 MSOP2.10 HPC 2.00 2016 Jun Heterotrophic Plate Count by SM9215B MSOP2.12 TCR 3.00 2016 Jun Total Coliform Rule: Invalidation of Total Coliform Samples MSOP2.13 SimPlate 2.00 2017 Mar Heterotrophic Plate Count by SimPlate MSOP2.14 Colisure 1.02 2017 Mar Presence/Absence of Total Coliforms and E. coli in Drinking Water by Colisure MSOP2.15 Enterolert 1.04 2016 Jun Enterococci: Most Probable Number (MPN) by IDEXX Enterolert MSOP2.16 PA18 1.02 2016 May Presence/Absence of Total Coliforms and E. coli by IDEXX Colilert-18 MSOP2.19 PA Notification 2.00 2018 Apr PA Coliform Notification MSOP3.00 BQLW 2.00 2018 Aug Bacteriological Quality of Laboratory Water (BQLW) MSOP3.01 Inhibitory Res 2.00 2018 Aug Inhibitory Residues on Glassware or Plasticware This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Organics SOPs (OSOP)
OSOP1.03 ManInt 1.02 2016 Jul Manual Integration Policy OSOP1.04 TIC 1.00 2016 Feb Tentatively Identified Compounds (TICs) OSOP2.01 Glass 2.01 2016 Jul Glassware Cleaning Procedure OSOP2.02 HazMat 3.00 2013 July Disposition of Hazardous Materials OSOP2.08 AcidVials 1.01 2016 Jul Acid Rinsing Vials
OSOP2.09 AcetoneVials 2.00 2018 Mar Acetone Rinsing Vials OSOP2.01 NaCl Wash 1.00 2018 Mar Sodium Chloride Washed with Methylene Chloride OSOP3.01 TPHD 6.00 2018 Jan Analysis of Diesel and Motor Oil in Soil and Water by LUFT/EPA Method 8015 OSOP4.01 PCB 4.01 2014 Apr HP6890 Analysis of Polychlorinated Biphenyls (PCBs) by EPA Method 8082 OSOP4.02 Pests 7.00 2019 Jan Analysis of Chlorinated Pesticides and PCBs: EPA 608, 8080 and 8081 OSOP4.03 Herbs 6.00 2013 Nov Analysis of Chlorinated Acids in Water: EPA Methods 8151 and 515.1 OSOP4.04 HAA5 3.00 2019 Jan Analysis of Haloacetic Acids and Dalapon in Drinking Water by EPA 552.2 OSOP4.06 OPP 2.01 2014 Apr Analysis of Organophosphorus Compounds: EPA Method 8141A OSOP4.07 507 2.00 2013 Nov Analysis of Nitrogen and Phosphorus Pesticides: EPA Method 507 OSOP4.08 508 3.00 2013 Nov Analysis of Chlorinated Pesticides and PCBs: EPA Method 508 OSOP6.01 TCLP 2.06 2016 Jul TCLP for Volatiles (by ZHE) and Semi-volatiles by EPA Method 1311 OSOP6.02 DIWET 2.06 2013 Oct DIWET for Volatiles (by Zero Headspace Extractor (ZHE)) and Semi-volatiles OSOP6.03 STLC 2.05 2013 Oct STLC for Volatiles (by Zero Headspace Extractor (ZHE)) and Semi Volatiles OSOP9.02 624&8260 5.00 2015 Jul Analysis of Volatile Organic Compounds by GCMS OSOP9.03 TPHG8260 3.00 2016DRAFT Analysis of Gasoline Range Organics by EPA Method 8260 OSOP9.05 524.2 3.00 2018 Feb Analysis of Volatiles in Drinking Water by GCMS Using EPA 524.2 and 1666 OSOP9.06 1666 1.00 2014 May VOCs Specific to the Pharmaceutical Industry by Isotope Dilution GCMS OSOP10.01 8270/625 4.00 2013 Nov Analysis of Semi Volatile Organic Compounds in Water by GC/MS: EPA 8270C OSOP10.01B 8270/625 BNZI 1.00 2017 Jan Analysis of Benzidine and 3,3-Dichlorobenzidine by GCMS EPA Methods 8270C and 625
OSOP10.03 548.1 1.00 2013 Sep Determination of Endothall in Drinking Water by EPA Method 548.1 OSOP11.01 531.1 3.00 2017 Apr Carbamates in Water by EPA Method 531.1 OSOP11.02 547 2.01 2015 Oct Glyphosate in Drinking Water by HPLC with Fluorescence Detection: EPA 547 OSOP11.03 549 2.00 2015 Aug Diquat and Paraquat in Drinking Water by EPA Method 549 OSOP11.04 504 2.00 2017 Dec Analysis of EDB and DBCP in DW by Microextraction and GC by EPA 525.2 OSOP11.05 525.2 1.01 2015 Jan Determination of Organic Compounds in DW by LSE/GCMS by EPA 525.2 OSOP11.06 8315 1.00 2018 Dec Determination of Formaldehyde in Drinking Water by Liquid-liquid Extraction and HPLC with UV Detection by EPA Method 83115A
OSOP APP1 N2 Blowdown 1.00 2013 Oct Extraction, Concentration, and Solvent Transfer with Nitrogen Concentrator This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Sample Control SOPs (SCSOP)
SCSOP1.00 Samp Rec 5.00 2017 Mar Sample Receiving Log-in SCSOP1.02 Temp 1.03 2016 Jul Monitoring Refrigerator Temperature in the Office SCSOP1.03 Sample Pres 2.0 2016 Jul Bottle and Sample Preserving Procedures SCSOP1.04 Sample Flow 3.01 2016 Jul Sample Flow in the Walk-in Refrigerator SCSOP1.07 AfterHoursCOC 1.02 2016 Jul After Hours Chains of Custody SCSOP1.08 PresChart 1.06 2015 Nov Preserving Bottles
SCSOP1.09 SampRecBAL 2.00 2018 May Sample Receiving Dublin SCSOP1.11 Notification 1.05 2016 Jul Client Notification of Perchlorate and NItrate/Nitrite in Drinking Water SCSOP1.12 Alum 1.01 2016 Jun Alum Calculation
SCSOP1.13 Cl2 3.00 2018 Aug Dechlorination Requirements SCSOP1.14 EQuiS 2.00 2016 Oct EQuiS EDD
SCSOP1.15 EDF Upload 1.01 2017 Junr EDF (Geotracker) Upload SCSOP1.16 EPA Dechlor 1.00 2013 Jun Dechlorinated Bottles SCSOP1.17 Shipping 2.00 2018 Apr Sample Shipping
SCSOP1.18 Disposal 1.01 2017 Jun Sample Disposal
SCSOP1.19 Couriers 1.00 2013 Jun Courier Responsibilities SCSOP1.20 Report Review 2.00 2016 Dec Report Review
SCSOP1.21 SSFDataReview 1.00 2016 Dec SSF Data Review
SCSOP1.22 SCM Dropdown 1.00 2017 Jan SCM Dropdown
SCSOP1.23 LLNL Upload 1.00 2017 Jan Uploading LLNL EDDs SCSOP1.24 Daly Monthly 1.00 2017 Jan Creating Dal City's Monthly EDD SCSOP1.25 Field Data 1.00 2016 Dec Entering Field Data at Login SCSOP1.26 Login Auditing 2.01 2017 Mar Login Auditing
SCSOP1.27 Geotracker EDF 1.00 2017 Feb Creating Geotracker EDF SCSOP1.28 WaterTrax EDD 1.00 2017 Feb Creating and Uploading Watertrax EDD SCSOP1.29 LOCUS EDD 1.00 DRAFT Creating and Uploading SJWC LOCUS EDDs SCSOP1.30 Spool Check 1.00 2017 Apr Daily Check for Spooling Errors SCSOP1.31 Satellite Sub 1.00 2018 Apr Subcontracting to Alpha Satellite Laboratories SCSOP1.32 Subcontractors 1.00 2018 Apr Subcontracting Laboratories SCSOP1.33 SampRecCV 1.00 2017 Jun Sample Receiving Elk Grove This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Toxicity SOPs (TSOP)
TSOP1.00 QA 2.03 2016 Jun Fish Bioassay Quality Assurance TSOP1.02 Hardness 1.04 2018 Jun Total Hardness Using the Hach Total Hardness Test Kit TSOP2.00 Arrival 2.00 2016 Jun Standard Operating Procedure for Fish Arrival TSOP3.00 Holding 2.03 2016 Jun Standard Operating Procedure for Holding Tank Log TSOP4.00 FishRoom 2.03 2016 Jun Standard Operating Procedure for Fish Room Readiness TSOP4.01 ControlWater 1.03 2016 Jun Standard Operating Procedure for Preparing Dilution or Control Water TSOP5.00 HWScreen 2.09 2016 Jun Standard Operating Procedure for Hazardous Waste Screen Bioassay TSOP5.01 HWDef 2.02 2016 Jun Standard Operating Procedure for Hazardous Waste Definitive Bioassay TSOP5.03 HWDisposal 2.01 2016 Jun Standard Operating Procedure for Hazardous Waste Bioassay Disposal TSOP6.00 %Survival 3.02 2016 Jun SOP for Effluents: Percent Survival of Rainbow Trout (Fourth Edition) TSOP7.00 KCl 4.01 2016 Jun Standard Operating Procedure for Reference Toxicant KCl TSOP7.01 SDS 1.02 2016 Jul Standard Operating Procedure for Reference Toxicant SDS This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Wet Chemistry SOPs (WCSOP)
WCSOP1.00 Labware 2.00 2018 May Labware Cleaning Procedures WCSOP2.01 Alkalinity 5.00 2018 Oct Analysis of Alkalinity, Bicarbonate, Carbonate, and Hydroxide by SM2320B WCSOP2.02 NH3 3.04 2017 Mar Analysis of Ammonia and Ammonia-N by Standard Method 4500-NH3 B and C
WCSOP2.03 COD 4.00 2019 Feb Chemical Oxygen Demand (COD) by Standard Method 5220D WCSOP2.05 Cond 6.00 2018 Apr Conductivity Analysis by SM2510B WCSOP2.06 CN 5.01 2018 Oct Analysis of Total and Amenable Cyanide WCSOP2.06A WADCN 2.00 2014 Nov Distillation of Weak-acid Dissociable (WAD) Cyanide WCSOP2.06B CN EPASM 3.00 2014 Aug Analysis of Total Cyanide by EPA 9014 or SM4500-CN E WCSOP2.07 CNReactive 3.00 2019 Feb Analysis for Reactive Cyanide WCSOP2.08 O&G Water 5.02 2017 Apr Grease and Oil: Hexane Extractable Material (HEM) in Water WCSOP2.10 O&G Soil 3.00 2016 Jul Grease and Oil: Hexane Extractable Material (HEM) in Soil or Sludge WCSOP2.16 MBAS 3.00 2018 Oct Analysis for Methylene Blue Active Substances (MBAS) by SM5540C WCSOP2.17 NO3NO2 4.00 2017 Dec Analysis of NO3+NO2-N in Water by SM4500-NO3 B and NO3 by Calculation
WCSOP2.18 NO2 4.00 2018 Oct Spectrophotometric Analysis of Nitrite and Nitrite-N in Water by SM4500- NO2 B
WCSOP2.20 pH 7.00 2018 Apr Electrometric pH Measurement of Water and Wastes WCSOP2.22 Phenolics 4.00 2019 Feb Analysis of Total Recoverable Phenolics in Water by EPA Method 420.1 WCSOP2.24 Settleable 2.02 2018 Feb Settleable Matter in Water by SM2540F WCSOP2.25 Silica 4.00 2017 Dec Analysis of Silica in Water by Standard Method 4500-SiO2 D WCSOP2.28 S2 Reactive 2.00 2016 Jul Analysis for Reactive Sulfide in Water and Soils WCSOP2.30 T&L 2.00 2016 Jun Colorimetric Analysis of Tannin and Lignin by Standard Method 5550B WCSOP2.31 TSS 4.00 2018 Oct Total Suspended (TSS) AKA NFR (Non-filterable Residue) by SM2540D WCSOP2.32 Solids 2.01 2016 Jul Analysis of Total Solids in Water by SM2540B WCSOP2.33 FSSVSS 2.00 2016 Jun Analysis of Fixed Suspended and Volatile Solids (FSS and VSS) by WCSOP2.34 TDS 3.01 2016 May Analysis of Total Dissolved Solids (TDS) AKA Filterable Residue by SM2540C
WCSOP2.35 %Solids 3.00 2017 Mar Determining Percent Solids by SM2540G WCSOP2.36 TFSTVS 4.00 2016 Nov Determination of Total Fixed, and Volatile Solids in Sludges and Solids WCSOP2.39 Turbidity 5.03 2018 Apr Determination of Turbidity by SM2130B WCSOP2.40 BOD 5.00 2018 Jun 5 Day Biochemical Oxygen Demand (BOD) by SM5210B WCSOP2.41 IC 3.04 2017 Mar Analysis of Anions in Water by Ion Chromatography WCSOP2.44 Unionized NH3N 2.01 2018 Oct Unionized Ammonia as Nitrogen WCSOP2.45 Anions 2.00 2016 Jun Total Anions
WCSOP2.46 Chlorine 3.01 2016 Apr Analysis of Residual Chlorine and Chloramine by Standard Method 4500- Cl F
WCSOP2.47 FreeCO2 2.00 2016 Jun Free Carbon Dioxide (CO2) Calculation by by SM4500-CO2 B WCSOP2.48 DO 2.00 2015 Mar Dissolved Oxygen by SM4500-O G WCSOP2.49 Nitrogen 2.00 2016 Jun Nitrogen: Inorganic, Organic, and Total by SM4500-N WCSOP2.50 TDS Calc 2.00 2016 Jun Total Dissolved Solids (TDS) Estimation This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment E
Standard Operating Procedures (SOPs)
Revision
Number Code Number Date Title

Wet Chemistry SOPs (WCSOP)
WCSOP2.51 FDSVDS 2.00 2016 May Determination of Fixed and Total Volatile Solids WCSOP2.52 SpecificGrav 1.01 2016 Jun Specific Gravity
WCSOP2.53 NH4 2.00 2016 Jun Ammonium Calculation
WCSOP2.54 Chlorophyll 2.00 2018 May Standard Operating Procedure for Chlorophyll by SM10200H WCSOP2.55 Sulfide 3.03 2018 Mar Analysis of Sulfide in Water by Hach Method 8131 Methylene Blue WCSOP2.56 H2S 2.00 2017 Jun Calculation of Hydrogen Sulfide in Water WCSOP2.57 Perchlorate 4.00 2016 Nov Determination of Perchlorate by EPA Method 314.0 WCSOP2.58 Prep 1.07 2018 Aug Prep Bench Procedure
WCSOP2.59 218.6 1.03 2018 Aug Analysis of Hexavalent Chromium in Drinking Water by EPA 218.6 WCSOP2.60 300.1 1.02 2016 Aug Analysis of Anions by EPA 300.1 WCSOP2.61 COD FF 1.00 2015 Jun Flocculation and Filtration for COD Analysis WCSOP2.62 CN9014 1.00 2017 Jul Distillation and Analysis of Total, Dissolved and Amenable CN by EPA 9010 and 9014
WCSOP2.63 CN4500 1.00 2018 May Analysis of Total CN by SM4500-CN E This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Wet Chemistry Analyses
Aqueous Soil and Solid Waste
Analyte mg/L Analyte mg/kg
Alkalinity 5.0 Cyanide 2.0
BOD 5.0 Cyanide, reactive 250
Chloride 0.50 Ignitability (flash point) 40°F
Chlorine, residual 0.10 Nitrogen, ammonia 52.0
COD 50 Nitrogen, Kjeldahl 10
Color 5 CU Oil and grease 250
Conductivity 20µmhos/cm Solids, total 1000
Cyanide 0.0030 Solids, volatile 1.0
Cyanide, reactive 250
Fluoride 0.10
Hardness 5.0
Nitrogen, ammonia 0.20
Nitrogen, Kjeldahl 1.0
Nitrogen, nitrate 0.20
Nitrogen, nitrite 0.20
Odor 1 TON
Oil and grease 5.0
Orthophosphate-P 0.10
Perchlorate 0.0040
Phenolics 0.050
Phosphorus 0.040
Silica 1.0
Solids, settleable 0.10ml/L
Solids, total 10
Solids, dissolved 10
Solids, suspended 1.0
Solids, volatile 1.0
Sulfate 0.50
Sulfide 0.10
Surfactants (MBAS) 0.050
Total organic carbon 0.30
Turbidity 0.10
CU = color units
TON = threshold odor number
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Metals: ICP and ICPMS
Aqueous (ug/L) Soil (mg/kg)
Analyte ICP ICPMS ICP
Aluminum 50 10 20
Antimony 20 0.50 15
Arsenic 10 0.50 2.0
Barium 10 0.50 10
Beryllium 1.0 0.10 0.75
Boron 200 50 50
Cadmium 10 0.10 1.0
Calcium 1000 NA 100
Chromium 10 0.50 5.0
Cobalt 10 0.10 10
Copper 20 0.50 10
Iron 100 50 50
Lead 50 0.25 5.0
Magnesium 1000 NA 50
Manganese 20 5.0 5.0
Molybdenum 500 0.25 5.0
Nickel 10 0.50 10
Phosphorus 500 NA 50
Potassium 1000 NA 50
Selenium 20 2.0 2.0
Silver 10 0.10 5.0
Sodium 1000 500 50
Thallium 200 0.10 7.0
Vanadium 20 1.0 5.0
Zinc 20 5.0 10
ICP = Inductively coupled plasma
ICPMS = Inductively coupled plasma mass spectrometry
Metals: Hexavalent Chromium and Mercury
Analyte Method Aqueous (ug/L) Soil (mg/kg)
Hexavalent Chromium EPA 218.6 1.0 -
Hexavalent Chromium SM3500Cr-B 10 -
Mercury EPA 7470A - 0.20
Mercury EPA 245.1 0.20 -
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Drinking Water Analyses
Analyte Method ug/L
1,2-Dibromoethane (EDB) EPA 504.1 0.020
1,2-Dibromo-3-chloropropane (DBCP) EPA 504.1 0.010
Alachlor EPA 507 1.0
Atrazine EPA 507 0.50
Molinate EPA 507 2.0
Simazine EPA 507 1.0
Thiobencarb EPA 507 1.0
Endrin EPA 508 0.10
γ BHC(Lindane) EPA 508 0.20
Heptachlor EPA 508 0.010
Heptachlor epoxide EPA 508 0.010
Hexachlorobenzene EPA 508 0.50
Hexachlorocyclopentadiene EPA 508 1.0
Methoxychlor EPA 508 10
PCB 1016 EPA 508 0.50
PCB 1221 EPA 508 0.50
PCB 1232 EPA 508 0.50
PCB 1242 EPA 508 0.50
PCB 1248 EPA 508 0.50
PCB 1254 EPA 508 0.50
PCB 1260 EPA 508 0.50
Toxaphene EPA 508 1.0
Chlordane EPA 508 0.10
Bentazon EPA 515.1 2.0
2,4-D EPA 515.1 10
Dalapon EPA 515.1 10
Dinoseb EPA 515.1 2.0
Pentachlorophenol EPA 515.1 0.20
Picloram EPA 515.1 1.0
2,4,5-TP (Silvex) EPA 515.1 1.0
Benzo(a)pyrene EPA 525.2 0.10
Di(2-ethylhexyl) adipate EPA 525.2 5.0
Di(2-ethylhexyl) phthalate EPA 525.2 3.0
Carbofuran EPA 531.1 5.0
Oxamyl EPA 531.1 20
Glyphosate EPA 547 25
Endothall EPA 548.1 45
Diquat EPA 549.2 4.0
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Drinking Water Analysis (cont.)
Analyte Method ug/L
Benzene EPA 524.2 0.50
Bromodichloromethane EPA 524.2 1.0
Bromoform EPA 524.2 1.0
Carbon tetrachloride EPA 524.2 0.50
Chlorobenzene EPA 524.2 0.50
Chloroform EPA 524.2 1.0
Dibromochloromethane EPA 524.2 1.0
1,2-Dichlorobenzene EPA 524.2 0.50
1,4-Dichlorobenzene EPA 524.2 0.50
1,1-Dichloroethane EPA 524.2 0.50
1,2-Dichloroethane EPA 524.2 0.50
1,1-Dichloroethene EPA 524.2 0.30
cis-1,2-Dichloroethene EPA 524.2 0.50
trans-1,2-Dichloroethene EPA 524.2 0.50
1,2-Dichloropropane EPA 524.2 0.50
1,3-Dichloropropane EPA 524.2 0.50
Ethylbenzene EPA 524.2 0.50
Methylene chloride EPA 524.2 0.50
Methyl-tert-butyl ether EPA 524.2 3.0
Styrene EPA 524.2 0.50
1,1,2,2-Tetrachloroethane EPA 524.2 0.50
Tetrachloroethene EPA 524.2 0.50
Toluene EPA 524.2 0.50
1,2,4-Trichlorobenzene EPA 524.2 0.50
1,1,1-Trichloroethane EPA 524.2 0.50
1,1,2-Trichloroethane EPA 524.2 0.50
Trichloroethene EPA 524.2 0.50
Trichlorofluoromethane EPA 524.2 5.0
Trichlorotrifluoroethane EPA 524.2 10
Trihalomethanes (total) EPA 524.2 1.0
Vinyl chloride EPA 524.2 0.50
Xylenes (total) EPA 524.2 0.50
Monochlorobromoacetic Acid EPA 552.2 1.0
Monochloroacetic Acid EPA 552.2 2.0
Dibromoacetic Acid EPA 552.2 1.0
Dichloracetic Acid EPA 552.2 1.0
Trichloroacetic Acid EPA 552.2 1.0
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Wastewater Analyses
Analyte Method ug/L
Aldrin EPA 608 0.005
α-BHC EPA 608 0.010
β-BHC EPA 608 0.005
γ BHC(Lindane) EPA 608 0.010
δ-BHC EPA 608 0.005
Chlordane EPA 608 0.050
4,4’-DDD EPA 608 0.020
4,4’-DDE EPA 608 0.020
4,4’-DDT EPA 608 0.010
Dieldrin EPA 608 0.010
Endosulfan I EPA 608 0.010
Endosulfan II EPA 608 0.010
Endosulfan sulfate EPA 608 0.050
Endrin EPA 608 0.010
Endrin aldehyde EPA 608 0.050
Heptachlor EPA 608 0.010
Heptachlor epoxide EPA 608 0.010
Methoxychlor EPA 608 0.020
PCB 1016 EPA 608 0.50
PCB 1221 EPA 608 0.50
PCB 1232 EPA 608 0.50
PCB 1242 EPA 608 0.50
PCB 1248 EPA 608 0.50
PCB 1254 EPA 608 0.50
PCB 1260 EPA 608 0.50
Toxaphene EPA 608 0.50
Azinphos methyl EPA 614 2.0
Chlorpyrifos EPA 614 0.5
Demeton-o EPA 614 1.0
Demeton-s EPA 614 1.0
Diazinon EPA 614 0.50
Disulfoton EPA 614 0.50
Ethion EPA 614 0.50
Malathion EPA 614 0.50
Parathion EPA 614 0.50
Parathion-methyl EPA 614 0.50
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Wastewater Analyses (cont.)
Analyte Method ug/L
Acenaphthene EPA 625 1.0
Acenaphthylene EPA 625 2.0
Anthracene EPA 625 2.0
Benzidine EPA 625 5.0
Benzo(a)anthracene EPA 625 2.0
Benzo(a)pyrene EPA 625 2.0
Benzo(b)fluoranthene EPA 625 2.0
Benzo(g,h,i)perylene EPA 625 2.0
Benzo(k)fluoranthene EPA 625 2.0
Bis(2-chloroethoxy) Methane EPA 625 2.0
Bis(2-chloroethyl) Ether EPA 625 1.0
Bis(2-chloroisopropyl) Ether EPA 625 1.0
Bis(2-ethylhexyl) Adipate EPA 625 5.0
Bis(2-ethylhexyl) Phthalate EPA 625 5.0
4-Bromophenyl Phenyl Ether EPA 625 4.0
Butylbenzyl Phthalate EPA 625 5.0
4-Chloro-3-methylphenol EPA 625 1.0
2-Chloronaphthalene EPA 625 2.0
2-Chlorophenol EPA 625 2.0
4-Chlorophenyl Phenyl Ether EPA 625 4.0
Chrysene EPA 625 2.0
Dibenz(a,h)anthracene EPA 625 2.0
3,3’-Dichlorobenzidine EPA 625 5.0
2,4-Dichlorophenol EPA 625 2.0
Diethyl Phthalate EPA 625 2.0
2,4-Dimethylphenol EPA 625 2.0
Dimethyl Phthalate EPA 625 2.0
Di-n-butyl Phthalate EPA 625 5.0
4,6-Dinitro-2-methylphenol EPA 625 4.0
2,4-Dinitrophenol EPA 625 5.0
2,4-Dinitrotoluene EPA 625 2.0
2,6-Dinitrotoluene EPA 625 2.0
Di-n-octyl Phthalate EPA 625 10
1,2-Diphenylhydrazine EPA 625 1.0
Fluoranthene EPA 625 1.0
Fluorene EPA 625 2.0
Hexachlorobenzene EPA 625 1.0
Hexachlorobutadiene EPA 625 1.0
Hexachlorocyclopentadiene EPA 625 4.0
Hexachloroethane EPA 625 1.0
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Wastewater Analyses (cont.)
Analyte Method ug/L
Indeno(1,2,3-cd) pyrene EPA 625 2.0
Isophorone EPA 625 1.0
Naphthalene EPA 625 1.0
Nitrobenzene EPA 625 1.0
2-Nitrophenol EPA 625 10
4-Nitrophenol EPA 625 10
N-Nitrosodimethylamine EPA 625 2.0
N-Nitrosodi-n-propylamine EPA 625 2.0
N-Nitrosodiphenylamine EPA 625 1.0
Pentachlorophenol EPA 625 5.0
Phenanthrene EPA 625 2.0
Phenol EPA 625 1.0
Pyrene EPA 625 2.0
1,2,4-Trichlorobenzene EPA 625 5.0
2,4,6-Trichlorophenol EPA 625 10
Pharmaceutical Pollutants in Wastewater
Analyte Method ug/L
Ethyl acetate EPA 1666 100
Isobutylaldehyde EPA 1666 100
Isopropyl acetate EPA 1666 100
Methyl formate EPA 1666 500
n-Amyl acetate EPA 1666 100
n-Butyl acetate EPA 1666 100
n-Heptane EPA 1666 100
n-Hexane EPA 1666 500
Acetone EPA 524.2 5.0
Benzene EPA 524.2 0.50
Chlorobenzene EPA 524.2 0.50
Chloroform EPA 524.2 0.50
1,2-Dichlorobenzene EPA 524.2 0.50
1,2-Dichloroethane EPA 524.2 0.50
Isopropyl ether EPA 524.2 1.0
Methylene chloride EPA 524.2 0.50
Methyl isobutyl ketone EPA 524.2 1.0
Tetrahydrofuran EPA 524.2 5.0
Toluene EPA 524.2 0.50
m.p-Xylene EPA 524.2 0.50
o-Xylene EPA 524.2 0.50
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Hazardous Waste Analyses
EPA 8081A Aqueous Solid Waste
Analyte ug/L mg/kg
Aldrin 0.010 0.0050
α-BHC 0.010 0.0050
β-BHC 0.050 0.0050
γ BHC(Lindane) 0.010 0.0050
δ-BHC 0.050 0.0050
Chlordane 0.050 0.20
4,4’-DDD 0.020 0.0050
4,4’-DDE 0.020 0.0050
4,4’-DDT 0.020 0.0050
Dieldrin 0.010 0.0050
Endosulfan I 0.010 0.0050
Endosulfan II 0.020 0.0050
Endosulfan sulfate 0.050 0.0050
Endrin 0.010 0.0050
Endrin aldehyde 0.050 0.0050
Heptachlor 0.020 0.0050
Heptachlor epoxide 0.020 0.0050
Methoxychlor 0.020 0.0050
Toxaphene 0.50 0.20
EPA 8082 Aqueous Solid Waste Oil
Analyte ug/L mg/kg mg/kg
PCB 1016 0.20 0.20 1.0
PCB 1221 0.20 0.20 1.0
PCB 1232 0.20 0.20 1.0
PCB 1242 0.20 0.20 1.0
PCB 1248 0.20 0.20 1.0
PCB 1254 0.20 0.20 1.0
PCB 1260 0.20 0.20 1.0
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Hazardous Waste Analyses (cont.)
EPA 8141A Aqueous EPA 8151A Aqueous
Analyte ug/L Analyte ug/L
Atrazine 0.50 Trichloronate 1.0
Azinphos ethyl 2.0 2,4-D 1.0
Azinphos methyl 2.0 2,4-DB 5.0
Bolstar 1.0 2,4,5-T 0.50
Chlorpyrifos 0.50 2,4,5-TP (Silvex) 0.50
Coumaphos 2.0 Dalapon 6.0
Demeton-o 1.0 Dicamba 0.40
Demeton-s 1.0 Dichlorprop 1.0
Diazinon 0.50 Dinoseb 1.0
Dichlorvos 1.0 MCPA 300
Dimethoate 2.0 MCPP 300
Disulfoton 0.50 Pentachlorophenol 0.20
EPN 1.0 Picloram 1.0
Ethion 0.50
Ethoprop (Ethoprophos) 1.0
Famphur 0.50
Fensulfothion 2.0
Fenthion 0.50
Malathion 0.50
Mevinphos 1.0
Parathion 0.50
Parathion-methyl 0.50
Phorate 0.50
Ronnel 0.50
Simazine 0.50
Stirofos 0.50
Thionazin 1.0
Tokuthion (Prothiofos) 1.0
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Hazardous Waste Analyses (cont.)
EPA 8260B Aqueous Aqueous Solid Waste
Analyte ug/L mg/kg
Acetone 5.0 0.70
Benzene 0.30 0.17
Bromobenzene 0.50 0.17
Bromochloromethane 0.50 0.17
Bromodichloromethane 0.50 0.17
Bromoform 0.50 0.17
Bromomethane 0.50 0.17
n-Butylbenzene 0.50 0.17
sec-Butylbenzene 0.50 0.17
tert-Butylbenzene 0.50 0.17
Carbon disulfide 5.0 NA
Carbon tetrachloride 0.50 0.17
Chlorobenzene 0.50 0.17
Chloroethane 0.50 0.17
Chloroform 0.50 0.17
Chloromethane 0.50 0.17
2-Chlorotoluene 0.50 0.17
4-Chlorotoluene 0.50 0.17
Dibromochloromethane 0.50 0.17
1,2-Dibromo-3-chloropropane 2.0 0.17
1,2-Dibromoethane (EDB) 0.50 0.17
Dibromomethane 0.50 0.17
1,2-Dichlorobenzene 0.50 0.17
1,3-Dichlorobenzene 0.50 0.17
1,4-Dichlorobenzene 0.50 0.17
Dichlorodifluoromethane 0.50 0.17
1,1-Dichloroethane 0.50 0.17
1,2-Dichloroethane 0.50 0.17
1,1-Dichloroethene 0.50 0.17
cis-1,2-Dichloroethene 0.50 0.17
trans-1,2-Dichloroethene 0.50 0.17
1,2-Dichloropropane 0.50 0.17
1,3-Dichloropropane 0.50 0.17
2,2-Dichloropropane 0.50 0.17
1,1-Dichloropropene 0.50 0.17
cis-1,3-Dichloropropene 0.50 0.17
trans-1,3-Dichloropropene 0.50 0.17
Ethylbenzene 0.50 0.17
Hexachlorobutadiene 0.50 0.17
2-Hexanone 5.0 NA
Isopropylbenzene 0.50 0.17
p-Isopropyltoluene 0.50 0.17
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Hazardous Waste Analyses (cont.)
EPA 8260B Aqueous Aqueous Solid Waste
Analyte ug/L mg/kg
Methyl tert butyl ether 0.50 0.17
Methyl ethyl ketone 1.0 0.35
Methyl isobutyl ketone 1.0 0.35
Methylene chloride 0.50 0.17
Naphthalene 0.50 0.17
n-Propylbenzene 0.50 0.17
Styrene 0.50 0.17
1,1,1,2-Tetrachloroethane 0.50 0.17
1,1,2,2-Tetrachloroethane 0.50 0.17
Tetrachloroethene 0.50 0.17
Toluene 0.30 0.17
1,2,3-Trichlorobenzene 0.50 0.17
1,2,4-Trichlorobenzene 0.50 0.17
1,1,1-Trichloroethane 0.50 0.17
1,1,2-Trichloroethane 0.50 0.17
Trichloroethene 0.50 0.17
Trichlorofluoromethane 0.50 0.17
Trichlorotrifluoroethane 0.50 0.17
1,2,3-Trichloropropane 0.50 0.17
1,2,4-Trimethylbenzene 0.50 0.17
1,3,5-Trimethylbenzene 0.50 0.17
Vinyl acetate 1.0 NA
Vinyl chloride 0.50 0.17
m,p-Xylene 0.50 0.35
o-Xylene 0.50 0.17
Xylenes (total) 0.50 0.35
EPA 8260B Appendix II Aqueous Additional Analytes
Analyte ug/L Analyte ug/L
Acetonitrile 100 Ethyl tert butyl ether 0.50
Acrolein 5.0 Hexachloroethane 1.0
Acrylonitrile 5.0 Isobutanol 100
Allyl chloride 10 Methacrylonitrile 1.0
Chloroprene 1.0 Methyl iodide 2.0
trans-1,4-Dichloro-2-butene 5.0 Methyl methacrylate 1.0 Di-isopropyl ether 0.50 Proprionitrile 50
Ethanol 50 Tert amyl methyl ether 0.50
Ethyl methacrylate 1.0
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Hazardous Waste Analyses (cont.)
EPA 8270C Aqueous Aqueous Solid Waste
Analyte ug/L mg/kg
Acenaphthene 10 0.062
Acenaphthylene 10 0.062
Anthracene 10 0.062
Benzidine 5.0 NA
Benzo(a)anthracene 10 0.33
Benzo(a)pyrene 10 0.062
Benzo(b)fluoranthene 10 0.062
Benzo(g,h,i)perylene 10 0.062
Benzo(k)fluoranthene 10 0.062
Benzoic acid 50 1.6
Benzyl alcohol 20 0.66
Bis(2-chloroethoxy) methane 10 0.33
Bis(2-chloroethyl) ether 10 0.33
Bis(2-chloroisopropyl) ether 10 0.33
Bis(2-ethylhexyl) phthalate 10 0.33
4-Bromophenyl phenyl ether 10 0.33
Butylbenzyl phthalate 10 0.33
4-Chloro-3-methylphenol 10 0.33
4-Chloroaniline 20 0.66
2-Chloronaphthalene 10 0.33
2-Chlorophenol 10 0.33
4-Chlorophenyl phenyl ether 10 0.33
Chrysene 10 0.062
Di-n-butyl phthalate 10 0.33
Di-n-octyl phthalate 10 0.33
Dibenz(a,h)anthracene 10 0.062
Dibenzofuran 10 0.33
1,2-Dichlorobenzene 10 0.33
1,3-Dichlorobenzene 10 0.33
1,4-Dichlorobenzene 10 0.33
3,3’-Dichlorobenzidine 5.0 NA
2,4-Dichlorophenol 10 0.33
Diethyl phthalate 10 0.33
Dimethyl phthalate 10 0.33
2,4-Dimethylphenol 10 0.33
4,6-Dinitro-2-methylphenol 50 1.6
2,4-Dinitrophenol 50 1.6
2,4-Dinitrotoluene 10 0.33
2,6-Dinitrotoluene 10 0.33
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment F
Practical Quantitation Limits

Organic Hazardous Waste Analyses (cont.)
EPA 8270C Aqueous Solid Waste
Analyte ug/L mg/kg
1,2-Diphenylhydrazine 10 0.33
Fluoranthene 10 0.062
Fluorene 10 0.062
Hexachlorobenzene 10 0.33
Hexachlorobutadiene 10 0.33
Hexachlorocyclopentadiene 15 1.6
Hexachloroethane 10 0.33
Indeno(1,2,3-cd) pyrene 10 0.062
Isophorone 10 0.33
2-Methylnaphthalene 10 0.062
2-Methylphenol 10 0.33
3 and 4-Methylphenol 10 0.33
N-Nitrosodi-n-propylamine 10 0.33
N-Nitrosodimethylamine 5 0.66
N-Nitrosodiphenylamine 10 0.33
Naphthalene 10 0.062
2-Nitroaniline 50 1.6
3-Nitroaniline 50 1.6
4-Nitroaniline 50 1.6
Nitrobenzene 10 0.33
2-Nitrophenol 10 1.6
4-Nitrophenol 50 1.6
Pentachlorophenol 50 1.6
Phenanthrene 10 0.062
Phenol 10 0.33
Pyrene 10 0.062
Pyridine NA 500
1,2,4-Trichlorobenzene 10 0.33
2,4,5-Trichlorophenol 10 0.33
2,4,6-Trichlorophenol 10 0.33
Fuels
Analyte Method Aqueous (ug/L) Soil (mg/kg)
Diesel EPA 8015B 250 1.0
Motor Oil EPA 8015B 250 2.0
Gasoline EPA 8260B 50 -
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment G
Major Instrumentation

Organics
Instrument Description LIMS Code

GCMS-VOA
Agilent 6890N gas chromatograph with 5973 mass spectrometer and volatiles interface, OI Eclipse purge and trap, EST Centurion autosampler, and HP Chemstation chromatography data system.

GCMS1
GCMS-SVOA Agilent 6890N gas chromatograph with 5973 mass spectrometer, Agilent 7683 autosampler, and HP Chemstation chromatography data system. GCMS3

GCMS-VOA
Agilent 7890A gas chromatograph with 5975 mass spectrometer and volatiles interface, OI Eclipse 4660 purge and trap, EST Centurion autosampler, and HP Chemstation chromatography data system.

GCMS4
GCMS-SVOA Agilent 7890A gas chromatograph with 5975C mass spectrometer, Agilent 7693 autosampler, and HP Chemstation chromatography data system. GCMS5

GCMS-VOA
Agilent 7890A gas chromatograph with 5977A mass spectrometer, OI Eclipse 4660 purge and trap, EST Centurion autosampler, and HP Chemstation chromatography data system.

GCMS6
GCMS-SVOA Agilent 7890B gas chromatograph with 5977 mass spectrometer, Agilent 7693 autosampler, and HP Chemstation chromatography data system. GCMS7 GC-FID Agilent 7890A gas chromatograph with FID and cool-on-column injector, Agilent 7693 autosampler, and HP Chemstation chromatography data system. HPdiesel2 GC-ECD Agilent 6890N gas chromatograph with dual ECDs, Agilent 7683B autosampler, and HP Chemstation chromatography data system. HPdECD2 GC-ECD Agilent 7890A gas chromatograph with dual ECDs and inlets, Agilent 7693 autosampler, and HP Chemstation chromatography data system. HPdECD3 GC-ECD Agilent 7890A gas chromatograph with dual ECDs, Agilent 7693 autosampler, and HP Chemstation chromatography data system. HPdECD4
GC-NP Agilent 6890N gas chromatograph with dual nitrogen-phosphorus detectors, Agilent 7693 autosampler and HP Chemstation chromatography data system. HPdNPD1 HPLC
Agilent 1100 high performance liquid chromatograph with fluorescence and diode array detectors, Pickering Pinnacle post-column derivatization system, and HP Chemstation chromatography data system.

HPLC1
HPLC Agilent 1100 high performance liquid chromatograph with diode array detector and HP Chemstation chromatography data system HPLC2
GC-ECD: Gas chromatograph with electron capture detector GC-FID: Gas chromatograph with flame ionization detector GC-NP: Gas chromatograph with nitrogen-phosphorus detector GCMS-SVOA: Gas chromatograph with mass spectrometer for semi-volatile organics analysis GCMS-VOA: Gas chromatograph with mass spectrometer for volatile organics analysis HPLC: High-performance liquid chromatograph
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.00
February 2019

8. Attachments
Attachment G
Major Instrumentation

Inorganics
Instrument Description LIMS Code
Balance Precisa XT220A analytical balance. XT220A
Balance Precisa LS 220A analytical balance. UKAB2
CVAAS Leeman mercury analyzer, model M7600 M7600
DO Meter YSI oxygen meter, model 58. DOYSI58
DO Meter YSI oxygen meter, model 5000. DO5000
EC Meter YSI conductance meter, model 3200. ECYSI2
Fluorometer Sequoia-Turner model 450 fluorometer. ST450 IC Metrohm 821 ion chromatograph with autosampler and data system. IC820 IC Metrohm 880 ion chromatograph with UV/VIS detector, autosampler, and MagicNet data system.

IC881
IC Metrohm 930 ion chromatograph with autosampler and MagicNet data system IC930A IC Metrohm 930 ion chromatograph with autosampler and MagicNet data system IC930B ICPAES Perkin Elmer Optima 7300DV simultaneous ICP with Perkin-Elmer S10 autosampler, and WinLab32 data acquisition system.

PE7300
ICPMS Perkin Elmer Sciex ELAN DRCII ICPMS with Cetac ASX-520HS autosampler and ELAN 3.5 data acquisition software

ELANDRCB
ICPMS Perkin Elmer Sciex ELAN DRCII ICPMS with Cetac ASX-510HS autosampler and ELAN 3.4 data acquisition software

ELANDRC
pH Meter ThermoScientific Orion Star LogR pH meter (Serial# L00628) pHSTAR2 pH Meter ThermoScientific Orion Star LogR pH meter (Serial# L00777) pHSTAR3 pH Meter Thermo Orion pH/ISE 710A meter. pH710
SPEC Lachat QuikChem 8500 Series 2 autoanalyzer with ASX 520 Series autosampler, Lachat micro-distillation system, and Omnion3.0 data acquisition software.

Lachat
SPEC Genesys Spectronic 20 spectrophotometer. SPEC20
SPEC Hach DR2800 spectrophotometer. DR2800
SPEC Milton Roy Spectronic 20 spectrophotometer. MRSPEC Turbidimeter HF Scientific Micro 100 turbidity meter. HF100 UVIR Teledyne Tekmar Fusion TOC analyzer FUSION
CVAAS: Cold-vapor atomic absorption spectrometer
EC Meter: Electric conductivity meter
DO Meter: Dissolved oxygen meter
GFAAS: Graphite-furnace atomic absorption spectrometer
IC: Ion chromatograph
ICPAES: Inductively-coupled plasma atomic emission spectrometer ICPMS: Inductively-coupled plasma mass spectrometer
SPEC: Spectrophotometer
UVIR: Ultra-violet infra-red TOC analyzer
This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.01
October 2019

9. Revisions

Revisions from 16.01 to 17.00: Effective Date March 13, 2015 General: Add signatures to title page.

Change <6 deg C to ≤6 deg C throughout document.

Section 1: Change ELAP reference from CDPH to SWRCB
Section 2: Update number of employees
Update Lab Director reference in 2.2.A to President.

Section 4: Change method references from methods to regulatory sources.

Attachment C: Include new laboratory addresses on chain of custody.

Attachment D: Change references from volumes of preservatives to pH required.

Update preservation, filtration, and/or hold time requirements on fluoride, orthophosphate, dissolved oxygent, pH, PCBs by EPA 6098, PCBs in oil by EPA 8082, bromate, bromide, chlorate, chlorite, radon, sulfite, and subcontracted Pharmaceutical Pollutants.

Update hold time for tributyltin (7 days per Enviromatrix, unspecified per McCampbell Analytical).

Correct SW846 method versions.

Attachment E: Add, update, and remove SOPs as needed.

Attachment F: Update phenolics reporting limit.

Remove graphite furnace references.

Add arsenic and selenium by ICP, hexavalent chromium by EPA 218.6, mirex and kepone by EPA 8081A, and picloram by EPA 8151A.

Revisions from 17.00 to 18.00: Effective Date July 15, 2016 Section 1.2.1: Remove reference to MSDSs.

Section 2.1: Update organizational chart and numbers of employees.

Replace references to “Laboratory Directors” with “Section Managers” Section 2.2.C: Replace “Laboratory Directors” with “Section Managers” Add “technicians” (2.2.C.2)
Section 3.5.1: Update work order number and year.

Section 4.2.1: Update description of MDL spike levels.

Section 4.3.8: Replace “Laboratory Directors and Sample Control” with “Section” Section 5.4.2: Change “re-extracted” to “re-prepared and reanalyzed”.

Section 6.1: Add “or pre-printed worksheet”.

Section 6.2.2: Change “Laboratory Directors” to “Section Managers” and “QAQC Officer” to “Quality Manager”.

Section 7.5: Add location of organics MSDSs.

Attachment D: Update descriptions, preservation, container, or method requirements on coliform, chloramines, chlorine (residual), cyanide (total), oil and grease, perchlorate, silica, solids (fixed and volatile), sulfide, turbidity, aqueous metals (total and dissolved), 1,2,3- trichloropropane, dioxins, 7 oxygenates, asbestos (soil), and sulfite.

Move bromate, bromide, chlorate, and chlorite from subcontracted to wet chemistry.\ Move Cr(VI) in soil from metals to subcontracted.

Add formaldehyde to subcontracted.

Replace “extraction” with “leaching” in TCLP table.

Remove UCMR3 table.

Attachment E: Add, update, and remove SOPs as needed.

Revisions from 18.00 to 19.00: Effective Date April 11, 2018 Section 1.2.3: Delete underground storage tank reference This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.01
October 2019

9. Revisions

Section 2.1: Update numbers of employees. Add paragraph regarding notification of ELAP.

Section 3.2.1.A: Delete specific temperature
Section 3.2.5.C: Typo
Section 3.3.1: Delete reference to cleaning
Section 3.5.1: Update example
Section 3.5.3: Add reference to semivolatiles refrigerator and samples that do not require refrigeration.

Section 4.1.2.A: Update date
Section 4.1.2.C-I: Update dates
Section 4.1.2.F: Add "Revised"
Section 4.1.2.H: Add "Long Term 2"
Section 4.1.2.J: Add
Section 4.1.3: Editorial
Section 4.2.1: Remove specific t-value
Update Appendix B revision number
Section 4.2.5: Delete
Section 6.3: Clarify
Attachment C: Update Bay Area Laboratory address
Attachment D: Add letters to microbiology methods
Move sulfite and UV254 form Subcontracted to Aqueous analyses Attachment E: Add, update, and remove SOPs as needed
Attachment F: Add, update, and remove analytes as needed Attachment G: Add, update, and remove instruments as needed Revisions from 19.00 to 20.00: Effective Date: February 28, 2019 Add "Table of Contents" to table of contents pages
Section 2.1: Update numbers of employees
Section 3.1.5: Editorial
Section 3.5.1: Update example dates
Section 3.5.3: Delete reference to lock and key.

Clarify acceptable refrigerator range.

Section 3.5.3.A: Remove HPLC samples from list.

Section 4.1.2: Add 4.1.2.K and 4.1.2.L.

Section 4.2.2: Replace description of procedure with reference.

Section 4.3: Change Attachment E to Attachment G.

Section 4.3.1: Editorial
Section 4.3.2: Editorial
Section 4.3.3: Editorial
Section 4.3.7: Editorial
Section 4.3.8: Editorial
Section 4.3.6: Delete acceptance criteria.

Section 5.1.1: Delete reference to ignitability.

Section 5.3.1: Add reference to sample duplicate.

Section 6.3: Editorial
Attachment C: Update.

Attachment D: Re-format tables
Remove analyses we no longer run
Update pH range in Cr6 wastewater entry.

Update 515.3 and 525.3
Attachment E: Update SOP list as needed
Attachment F: Remove ignitability and total solids in soil to Wet Chemistry Analyses This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.01
October 2019

9. Revisions

Update ICP Ca in soil, add P to Metals table
Update EPA 608 and EPA 625 limits as needed
Remove Kepone and Mirex from EPA 8081A list
Add Atrazine to EPA 8141A Aqueous list
Add Pyridine to EPA 8270C Solid Waste list
Attachment G: Delete flash tester from Inorganics Major Instrumentation list Correct typo on IC820 description
Replace ELAN with ELANDRC2
New autosampler for ELANDRC
Revisions from 20.00 to 20.01: Effective Date: See Cover Page Section 6.2.4.b: Add reference to ELAP certificate number.

This document for management system review only.

May not be used for any other purpose without written permission.

Alpha Analytical Laboratories, Inc. Quality Assurance Plan Revision 20.01
October 2019

9. Revisions

This page intentionally left blank.

This document for management system review only.

May not be used for any other purpose without written permission.

October 27, 2022
Cheryl Watson
Alpha Analytical Laboratories
208 Mason Street
Ukiah, CA 95482
Re: Closure of Laboratory Assessment for CA ELAP Renewal and Amendment Application Cheryl:

Attached is a copy of the IAS review of the Corrective Action Request (CAR) associated with the July 18 and August 11, 2022 on-site assessment for renewal accreditation. The original response to the CARs were received on September 5, 2022 from the laboratory with the second response received September 27, 2022. The final closure for these responses being the date of this letter.

Overall, this CAR response was found to directly address the deficiencies cited during the assessment. Where required, root cause analyses were also submitted for these deficiencies and found to be satisfactory.

IAS has appreciated working with you and your staff and wish you all the best in the future.

Please do not hesitate to contact Dr. Tony Francis at (801) 999-8293 or [email protected] if we can provide any additional information or assistance.

Sincerely,
Tony Francis
IAS Contract Assessor
Enclosures
cc: Mr. Mohan Sabaratnam

Assessment Report
For
Alpha Analytical Laboratories
208 Mason Street
Ukiah, CA 95482
CA ELAP Certificate #: 1551
Designated Representative: Cheryl Watson
Performed:

July 18 and August 11, 2022
By Tony Francis, PhD, IAS
Michelle Berrett-Muir, IAS
On Behalf Of:

California Environmental Protection Agency
State Water Resources Control Board
California Environmental Laboratory Accreditation Program P. O. Box 100
Sacramento, CA 95812-0100
Submitted by: Tony Francis
Reviewed by: Heather Tohinaka
Issued on: August 21, 2022

ASSESSMENT REPORT
I. Introduction:

Alpha Analytical Laboratories – Ukiah was assessed on-site and remotely to verify compliance with California ELAP HSC § 100829 and § 100830, which incorporates by reference the 2016 Environmental Laboratory standards adopted at The NELAC Institute (National Environmental Laboratory Accreditation Conference) with some exceptions.

The assessment included a review of the laboratory’s quality system, technical processes, instrumentational operations, data review and reporting, and associated laboratory records. Laboratory operations were reviewed only as they applied to the analytes, matrices, and testing included on the scope of accreditation.

II. Scope:

The assessment involved laboratory areas producing data that pertain to ELAP’s programs. The assessment was based on the pertinent requirements appearing in:

California ELAP HSC § 100829 and 100830, the laboratory’s quality assurance documentation including its quality manual, standard operating procedures (SOPs), and related documents, methods published by Environmental Protection Agency (EPA) and Standard Methods, Title 40, Code of Federal Regulations, Part 141 (40 CFR 141), Title 40, Code of Federal Regulations, Part 136 (40 CFR 136), and other documents applicable to EPA and ELAP programs.

Alpha Analytical Laboratories – Ukiah is seeking accreditation with the California Environmental Laboratory Accreditation Program (ELAP) for laboratory analysis methods under the California Code of Regulations (CCR), Title 22, Division 4, Chapter 19, Certification of Environmental Laboratories.

The assessment was performed onsite July 18, 2022 by Tony Francis, and Michelle Berrett-Muir, Technical Specialist and remotely August 11, 2022 by Tony Francis. The purpose was the reassessment and scope expansion assessment for ELAP accreditation.

The following methods were reviewed during the on-site scope expansion assessment:

Analyte Method Matrix
1,2-Diphenylhydrazine EPA 625.1 Non-Potable Water
2-Methylphenol (o-Cresol) EPA 625.1 Non-Potable Water
3,4-Methylphenol (m,p-Cresol) EPA 625.1 Non-Potable Water t-Butyl alcohol (2-methyl 2-propanol)
EPA
8260B Hazardous Waste (Matrix Aqueous)
Diisopropyl ether (DIPE)
EPA
8260B Hazardous Waste (Matrix Aqueous)
Ethyl t-butyl ether (ETBE)
EPA
8260B Hazardous Waste (Matrix Aqueous)
t-Amyl methyl ether (TAME)
EPA
8260B Hazardous Waste (Matrix Aqueous)

III. Materials Selected for Review
This report and the attached tables represent the conditions observed in the facility at the time of the assessment and during review of laboratory documents and records.

Table 1 represents the Standard Operating Procedures (SOPs) that were reviewed as part of this assessment. Conditions identified in the course of the assessment that fail to satisfy the requirements of the CCR, Title 22, Division 4, Chapter 19 are described in the attached List of Findings. An electronic copy of the List of Findings, in MS Word format, is included, to be used by the laboratory to prepare their corrective action plan.

IV. Data Package Review
A list of the data packages or other records that were reviewed during the assessment is shown in Table 2.

V. Observations
The laboratory has been generating data from an existing scope of accreditation for many years. Laboratory staff includes administrative, management, and technical personnel. Nathan Holloway, Martha Younger, and Zee Hopper are the Technical Managers for organic chemistry, inorganic chemistry, and microbiology respectively.

Cheryl Watson is the QA Manager. The laboratory has been in the same facility as the previous assessment. All non-compatible methods have been suitably segregated. The laboratory had elected to be assessed to the 2016 TNI Standard (minus two) in addition to current CA ELAP regulations.

Table 1
Materials Selected for Review
Parameter Reference
Method Standard Operating Procedure
Quality Management System N/A EMRL Activity Level Quality Assurance Plan, Rev. 4.5
Thermometers N/A Thermometer Calibration, Rev 2.10
Pipettes N/A Pipetter Calibration and Maintenance,
Rev 4.01
Document Control N/A Document Control SOP, Rev 3.02
Balances N/A Analytical Balance, Rev 1.04
Proficiency Testing N/A Analysis and Reporting of PT
Samples, Rev 3.00
MDLs N/A Establishing Method Detection Limits,
Rev 2.01
Training N/A Training Documentation, Rev 2.02
Corrective Actions N/A Documentation of Non-Compliance
and Corrective Action, Rev 1.01
Purchasing N/A Purchasing: Approvals and Records,
Rev 1.01
Internal Audit N/A Internal Audit, Rev 1.01
Mercury EPA 245.1/7470
Digestion and Analysis of Mercury in
Water by EPA Method 245.1/7470,
Rev 4.07
Metals EPA 200.7 Trace Metal Analysis by Inductively
Coupled Plasma (ICP), Rev 4.00
TOC SM 5310 C
Analysis of Total Organic Carbon
(TOC) and Dissolved Organic Carbon
(DOC), Rev 6.04
Chromium VI EPA 7196 A Analysis of Hexavalent Chromium by EPA Method 7196A, Rev 2.04
Hardness SM 2340 B Hardness: Total, Calcium, and
Magnesium, Rev 1.04
Metals EPA 200.8 Trace Metal Analysis by ICPMS, Rev

5.03 Anions EPA 300.0 Analysis of Anions by Ion
Chromatography, Rev 1.01

Anions EPA 300.1 Analysis of Drinking Water Anions by
EPA 300.1, Rev 1.02
Chromium VI EPA 218.6 Analysis of Cr6 in Drinking Water and Wastewater by EPA 218.6, Rev 1.02
Orthophosphate SM 4500-P F Analysis of orthophosphate in Water by SM 4500-P F, Rev 1.01
Phosphorus SM 4500-P F
Analysis of Phosphorus and
Phosphate in Water by SM 4500-P F,
Rev 1.01
TKN EPA 351.2 Analysis of Total Kjeldahl Nitrogen by
EPA Method 351.2, Rev 1.02
Ammonia SM 4500-NH3 G Analysis of Ammonia-Nitrogen by SM 4500-NH3 G, Rev 1.01
WET
CCR Chapter11,
Article 5, Appendix
II
STLC WET Extraction, Rev 3.02
Total Coliforms and E. Coli SM 9223 B Colilert
Presence/Absence of Total and E.
coli in Drinking Water by SM9223,
Rev 2.02
Total and Fecal Coliforms SM 9221 B/C/E
Total and Fecal Coliforms: Most
Probable Number (MPN) 15 Tube by
SM9221, Rev 2.10
Total Coliforms and E. Coli SM 9223 B
Total Coliforms and E. Coli in
Drinking Water by SM9223
QuantiTray, Rev 2.04
HPC SM 9215 B Heterotrophic Plate Count by
SM9215B, Rev 2.02
HPC IDEXX SimPlate Heterotrophic Plate Count by
SimPlate, Rev 2.02
Enterococci IDEXX Enterolert
Enterococci: Most Probable Number
(MPN) by IDEXX Enterolert, Rev 1.07
PCBs EPA 8082
HP6890 Analysis of Polychlorinated
Biphenyls (PCBs) by EPA Method
8082, Rev 5.01
Pesticides and PCBs EPA 608.3/8081 A
Analysis of Chlorinated Pesticides
and PCBs: EPA 608.3 and 8081, Rev

8.00 HAAs EPA 552.2
Analysis of Haloacetic Acids in
Drinking Water by EPA 552.2, Rev

3.02

Organophosphorus Pesticides EPA 8141 A
Analysis of Organophosphorus
Compounds: EPA Method 8141A,
Rev 3.01
Pesticides EPA 507
Analysis of Nitrogen and Phosphorus
Pesticides: EPA Method 507, Rev

3.01 Pesticides and PCBs EPA 508
Analysis of Chlorinated Pesticides
and PCBs by GC and ECD: EPA
Method 508, Rev 4.01
Chlorinated Herbicides EPA 515.3/8151 A
Determination of Chlorinated
Herbicides in Water by GC with an
ECD: EPA Methods 515.3 and
8151A, Rev 3.00
VOC EPA 624.1/8260 B Analysis of Volatile Organic
Compounds by GCMS, Rev 6.01
VOC/Isopropyl Ether EPA 524.2
Analysis of Volatiles in Drinking
Water by GCMS Using EPA 524.2
and 1666, Rev 4.02
SVOC EPA 8270C/625.1
Analysis of Semi Volatile Organic
Compounds in Water by GC/MS:

EPA 8270C/625.1, Rev 7.00
Endothall EPA 548.1
Determination of Endothall in
Drinking Water by EPA Method
548.1, Rev 1.02
SVOC EPA 525.3
Determination of Semi-volatile
Organic Compounds in Drinking
Water by Capillary Column GCMS:

EPA 525.3, Rev 2.00
Carbamates EPA 531.1 Carbamates in Water by EPA Method
531.1, Rev 4.01
Glyphosate EPA 547
Glyphosate in Drinking Water by
HPLC with Fluorescence Detection:

EPA 547, Rev 3.01
Diquat EPA 549.2
Diquat and Paraquat in Drinking
Water by EPA Method 549.2, Rev

3.01 EDB/DBCP EPA 504.1
Analysis of EDB and DBCP in DW by
Microextraction and GC by EPA
525.2, Rev 2.02
Formaldehyde EPA 8315A Determination of Formaldehyde in Drinking Water by Liquid-liquid
Extraction and HPLC with UV

Detection by EPA Method 8315A,
Rev 1.01
Alkalinity SM 2320 B
Analysis of Alkalinity, Bicarbonate,
Carbonate, and Hydroxide by
SM2320B, Rev
Ammonia SM 4500-NH3 B
Analysis of Ammonia and AmmoniaN by Standard Method 4500-NH3 B and C, Rev 7.00
COD SM 5220 D Chemical Oxygen Demand (COD) by
Standard Method 5220D, Rev 3.05
Conductivity SM 2510 B Conductivity Analysis by SM2510B, Rev 6.02
Cyanide Quickchem 10-
204-00-1-X
Analysis of Total and Dissolved
Cyanide, Rev 7.01
HEM EPA 1664 A Grease and Oil: Hexane Extractable
Material (HEM) in Water, Rev 8.00
Surfactants SM 5540 C
Analysis for Methylene Blue Active
Substances (MBAS) by SM5540C,
Rev 4.00
Nitrate SM 4500-NO3 B
Analysis of NO3+NO2-N in Water by
SM4500-NO3 B and NO3 by
Calculation, Rev 4.01
Nitrite SM 4500-NO2 B
Spectrophotometric Analysis of Nitrite
and Nitrite-N in Water by SM4500-
NO2 B, Rev 4.02
pH SM 4500-H+ B Electrometric pH Measurement of
Water and Wastes, Rev 7.02
Phenols EPA 420.1
Analysis of Total Recoverable
Phenolics in Water by EPA Method
420.1, Rev 4.03
Settleable Residue SM 2540 F Settleable Matter in Water by SM2540F, Rev 2.04
Silica SM 4500-SiO2 D
Analysis of Silica in Water by
Standard Method 4500-SiO2 D, Rev

4.02 TSS SM 2540 D
Total Suspended (TSS) AKA NFR
(Non-filterable Residue) by
SM2540D, Rev 4.02
TS SM 2540 B Analysis of Total Solids in Water by
SM2540B, Rev 2.03

TDS SM 2540 C
Analysis of Total Dissolved Solids
(TDS) AKA Filterable Residue by
SM2540C, Rev 3.03
Volatile Solids SM 2540 E
Determination of Total Fixed, and
Volatile Solids by SM2540E, Rev

4.02 Turbidity SM 2130 B Determination of Turbidity by
SM2130B, Rev 5.05
BOD SM 5210 B 5 Day Biochemical Oxygen Demand
(BOD) by SM5210B, Rev 6.00
Chlorine SM 4500-Cl F
Analysis of Residual Chlorine and
Chloramine by Standard Method
4500-Cl F, Rev 4.01
DO SM 4500-O G Dissolved Oxygen by SM4500-O G,
Rev 3.00

Table 2
Review of Data Packages and Other Materials
Parameter
Data Package Identifier
(Sample #’s)
Corrective Actions Deficiency & Nonconformance Reporting System records, 2022
Performance and System Audits Pre-audit review, 2022
Proficiency Testing ERA PT Studies 2021 and 2022
Sample Receiving Log-In Record Sheets, 2021 and 2022
Sample Receiving Chains-of-Custody, 2021 and 2022
Reporting Case Summary, 2021 and 2022
Balances Rice Lake certificates dated 2/7/2022
Weight Sets Rice Lake certificate #3259703A and
#3259703B
Pipettes Rainin certificates dated 5/26/2021
Balances Balance Calibration Verification
Logsheets, 2021 and 2022
Sample Receiving Wastewater pH Logbook, LOG-EM-238
Microbiology Het PC SimPlate 24hr, 2022
Microbiology Bacteriology Quality of Lab Water, 2022
Microbiology Autoclave Log, 2022
Microbiology Autoclave Sterilization Check, 2022
Microbiology 2022 Refrigerator Temperature Log,
2022
Microbiology 2022 Incubator Temperature Log, 2022
Microbiology Microbiology Pipet Log, 2022
Microbiology Media Prep Log, 2022
Microbiology Tube Media Controls, 2022
Microbiology QuantiTray Sealer Check, 2018 to 2022
BOD BOD Worksheets, 2022
COD COD logbook #13
Conductivity Daily Conductivity Log, 2022

Turbidity Daily Turbidity Log, 2022
Organics Extraction Log, 2022
Organics Extraction Reagent worksheets, 2022
Instrument maintenance Maintenance logs, 2022
pH pH Meter Logs, 2022
Balance Precisa LS 220 A logbook, 2018 to 2022
Sample Receiving Sample Preservation Log, 2022
TDS TSS Oven Log, 2022
TSS TSS Oven Log, 2022
Alkalinity Alkalinity Worksheets, 2022
8141 data Batch #AF24069
Alkalinity data Batch #AF24337
Ammonia data Batch #AE24024
Anions (EPA 300.0) data Batch #AG23828
Anions (EPA 300.1) data Batch #AG23734
BOD data Batch #AG23357
Carbamates data Batch #AG23505
Chlorinated acids data Batch #AG23250
Chromium VI data Batch #AF24436
COD data Batch #AE23727
Conductivity data Batch #061222
Cyanide data Batch #AG23894
Diquat data Batch #AG23344
Dissolved Oxygen data Batch #AF23082
EDB/DBCP data Batch #AG23625
Endothall data Batch #AG23180
Enterococci data Batch #071322
Fecal coliforms data Batch #071322
Formaldehyde data Batch #AF23716
Glyphosate data Batch #AF23991
HAAs data Batch #AF23922
HEM data Batch #AF24166

Herbicides data Batch #AG23588
HPC data Batch #AE24547
Isopropyl ether data Batch #AG23334
MBAS data Batch #AA24032
Metals (EPA 200.7) Batch # AF24182
Metals (EPA 200.8) Batch # AF24207
Nitrate data Batch #AC2467
PCBs data Batch #AF23285
Pesticides (EPA 507) data Batch #AF24444
Pesticides (EPA 508) data Batch #AF23836
Pesticides (EPA 608.3) data Batch #AF24278
Pesticides (EPA 614) data Batch #AF23214
Pesticides (EPA 8081 A) data Batch #AF23184
pH data Batch #AE25057
Phosphorus data Batch #AF24574
Settleable residue data Batch #AE24031
SVOC (EPA 525.3) data Batch #AF24035
SVOC (EPA 625.1) data Batch #AF23956
SVOC (EPA 8270 C) data Batch #AF24373
TDS data Batch #AG23642
TKN data Batch #AF23819
TOC data Batch #AG23549
Total coliforms and E. coli SM 9223 B Colilert
data Batch #071222
Total coliforms by SM 9221 B/C data Batch #071222
TS data Batch #AF23059
TSS data Batch #AF23552
Turbidity data Batch #AE24489
VOCs (EPA 524.2) data Batch #AG23598
VOCs (EPA 624.1) data Batch #AG23691
VOCs (EPA 8260) data Batch #AG23600
Volatile residue data Batch #AF24125

Attachments
The report contains electronic copies of the attachments listed below.

Attachment 1. Scope (Including sign-off of Methods/Analytes/Matrices/Technologies Reviewed and any footnotes as required to identify changes and additions.) Attachment 2. Assessment Checklist(s)
Attachment 3. Facility Organizational Chart
Attachment 4. Attendance at Initial and Final Briefing
Attachment 5. Assessment Interviewee Form

LIST OF FINDINGS
Included in this report is a list of the findings (deficiencies) that were identified during the assessment and the review of the laboratory’s documents and records. Each numbered item identifies an individual finding and references the applicable Standard clause and/or section that establish the requirement that was not met.

The laboratory must submit a corrective action report (CAR) that addresses each of the cited findings.

The laboratory response must be concrete, detailed, and specific, and must describe how the corrective action will be implemented. Where changes to procedures are appropriate, the submitted CAR shall include the location and summary of the change and provisions for training and follow up to ensure effectiveness of the change. The response must include a proposed date of completion for each finding and the name of the person responsible for completing the corrective action.

CORRECTIVE ACTION REQUESTS (CARs)
CAR 1
2016 TNI Standard 2016 TNI Standard V1M2-4.13.2.1
Requirement
The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period.

Finding
Laboratory staff stated when manual integrations occurred during VOC analyses by EPA 524.2, the original raw data had not been retained.

Records of initial, automated integrations for manually integrated peaks could not be retrieved.

Laboratory Response
including Root cause
analysis
Initial, automated integrations are retrievable. SOPS for manual integration (Section 4.5) and EPA 524.2 (Section 9.4.1) have been updated to address storage of initial integrations. An example of retrieved initial and manually integrated data from batch AG23598 is attached. See CAR 1 Responses.

IAS 1st Response Laboratory response not acceptable. Changes to laboratory documents require evidence of staff training.

Laboratory 2nd Response Training of the appropriate personnel has been documented. See CAR1 2nd Response.

IAS 2nd Response Laboratory response likely to prevent recurrence.

CAR 2
2016 TNI Standard 2016 TNI Standard V1M2-4.13.3.f.v and vi Requirement
All information necessary for the historical reconstruction of data shall be maintained by the laboratory including:
1) instrumentation identification and instrument operating conditions/parameters (or reference to such data), and
2) time of analysis is required when time critical steps are included in the analysis (e.g., extractions and incubations).

Finding
1) Weekly temperature check records of autoclave ID AC02 did not identify the thermometer used.
2) The drying time for total dissolved solids had not been recorded. Although the laboratory recorded the drying start time, the end time had not been recorded.

Laboratory Response
including Root cause
analysis
1) Autoclave Log has been amended to include the thermometer ID used for weekly temperature checks. See CAR 2.1 Response. 2) TDS Oven Log have been amended to include fields for drying start and end times. TDS SOP has been amended to reference the requirement (Section 9.3.6). Analysts have had documented training. See CAR 2.2 Response
IAS 1st Response Laboratory response likely to prevent recurrence.

CAR 3
2016 TNI Standard 2016 TNI Standard V1M2-5.5.13.1.c
Requirement
On each day the equipment is used, balances, ovens, refrigerators, freezers, incubators and water baths shall be checked and documented. The acceptability for use or continued use shall be according to the needs of the analysis or application for which the equipment is being used.

Finding
Refrigerator ID WC05, where chemical standards are stored, had not been checked or temperature acceptability on weekends and holidays.

Other equipment with missing temperatures had also been observed including the sample storage refrigerator for solids.

Laboratory Response
including Root cause
analysis

1. Quality manager (Cheryl Watson) began monitoring all refrigerator and incubator logs weekly on 08/01/22.

2. Corrective action forms are completed by each employee who fails to record temperatures as required.

3. Quality manager will continue to monitor weekly until all temperatures are properly recorded for four consecutive weeks.

4. Quality manager will check logs again within sixty days from completion of (3).

5. If non-compliance recurs, the monitoring will resume from step (1).

6. See CAR 3 Response
IAS 1st Response Laboratory response likely to prevent recurrence.

CAR 4
2016 TNI Standard 2016 TNI Standard V1M4-1.7.1.1.j
Requirement Criteria for the acceptance of an initial calibration shall be established (e.g., correlation coefficient or relative standard deviation).

Finding Acceptance criteria for pH slope calibrations had not been established in the associated SOP.

Laboratory Response
including Root cause
analysis
The pH meter manufacturer’s slope acceptance range is 95-105%. The range has been added to the pH Meter Log and the SOP updated (Sections 9.2.10 and 10.3). Analysts have had documented training.

See CAR 4 Response.

IAS 1st Response Laboratory response likely to prevent recurrence.

CAR 5
2016 TNI Standard
1) 2016 TNI Standard V1M5-1.7.3.1.a,
2) 2016 TNI Standard V1M5-1.7.3.7.b.iii.b
3) 2016 TNI Standard V1M5-1.7.5.c
Requirement
1) All materials and supplies that are needed to process the sample and are required to be sterile prior to use (whether sterilized in the laboratory or purchased as sterilized) must be checked by the laboratory once per purchased or prepared lot using non-selective growth media as appropriate.
2) Equipment, such as filter funnels, bottles, non-Class A glassware, and other containers with volumetric markings (including sample analysis vessels), shall be verified once per lot prior to first use.
3) One container from each batch of laboratory-prepared containers or lot of purchased ready-to-use containers is checked to ensure efficacy of the sodium thiosulfate to 5 mg/L chlorine or 15 mg/L chlorine as appropriate and the check is documented;
Finding
1) Records of sterility verifications for sterile vessels used for microbiological testing could not be retrieved.
2) Records of volumetric verifications for sterile vessels used for microbiological testing could not be retrieved.
3) Records of sodium thiosulfate efficacy checks of sterile vessels used for microbiological testing could not be retrieved.

Laboratory Response
including Root cause
analysis
Each lot of sterile vessels received for microbiological testing in the Ukiah lab are now being verified for sterility, volume accuracy, and sodium thiosulfate efficacy in the Ukiah lab. Alpha’s retired SOP has been updated, the current lot of sterile vessels tested, and analyst training documented. See CAR 5 Response.

IAS 1st Response Laboratory response likely to prevent recurrence.

CAR 6
2016 TNI Standard 2016 TNI Standard V1M5-1.7.3.3
Requirement
If the laboratory has two (2) or more analysts, each analyst shall count typical results on the same sample. Counts shall be within ten percent (10%) difference to be acceptable.

Finding Laboratory management stated analyst duplicates had not been performed. Records of analyst duplicate counts could not be retrieved.

Laboratory Response
including Root cause
analysis
We have implemented a procedure for running monthly micro variability checks. The SOP and draft log of the check for August (after 08/20/22) included in CAR 6 Response.

IAS 1st Response Laboratory response not acceptable. Changes to laboratory documents require evidence of staff training.

Laboratory 2nd Response Training of the appropriate personnel has been documented. See CAR 6 2nd Response.

IAS 2nd Response Laboratory response likely to prevent recurrence.

CAR 7
Reference Method EPA 1664 A-7.3
Requirement Reagents and Standards; n-Hexane—85% minimum purity, 99.0% min. saturated C6 isomers, residue less than 1 mg/L.

Finding
The Certificate of Analysis for the n-Hexane used by the laboratory, ED837, indicated n-Hexane at 66.4%.

Laboratory Response
including Root cause
analysis
We have located a source for n-Hexane that meets EPA 1664A specs.

See CAR 7 Response for certificate of analysis. Estimated ship date is 11/01/22. When the solvent arrives, we will:
• Test to confirm <5 mg/L O&G (Zee Hopper)
• Update reagents section of SOP (Cheryl Watson)
Responsible party in parentheses
Proposed date of completion: 11/15//22
IAS 1st Response Laboratory response likely to prevent recurrence.

CAR 8
Reference Method Standard Method 2130 B-5 Table 1
Requirement
Report turbidity readings as follows:

Turbidity Range (NTU) Report to the Nearest (NTU)
0–1.0 0.05
1–10 0.1
10–40 1
40–100 5
100–400 10
400–1000 50
>1000 100
When comparing water treatment efficiencies, do not estimate turbidity more closely than specified above. Uncertainties and discrepancies in turbidity measurements make it unlikely that results can be duplicated to greater precision than specified.

Finding
Laboratory staff stated turbidity results had been reported as observed on the instrument, without rounding. Records indicated rounding had not been performed.

Laboratory Response
including Root cause
analysis
We have prepared a spreadsheet to calculate the result to report from raw turbidity readings. LIMS reporting algorithm has been updated to report as required. Our turbidity SOP has been updated (Sections 9.4.2 and 9.4.3) and analyst training documented. See CAR 8 Responses IAS 1st Response Laboratory response likely to prevent recurrence.

CAR 9
Reference Method Standard Method 2540 D-3.c
Requirement
Stir or mix the sample and use a pipet or graduated cylinder to transfer a measured volume onto a glass fiber filter with applied vacuum. Wash the filter with at least 3 successive volumes of 10 mL or more of reagent-grade water.

Finding Laboratory staff stated, when a sample is slow to filter, not all sample measured in the graduated cylinder is transferred to the filter. Note:

solids can settle in the graduated cylinder and bias the results low if not all used.

Laboratory Response
including Root cause
analysis
Our laboratory staff has been trained and SOP updated (Section

9.3.4.A) to ensure that all measured sample is transferred to the filter.

See CAR 9 Response.

IAS 1st Response Laboratory response likely to prevent recurrence.

CAR 10
Reference Method Standard Method 5210 B-5.c.1
Requirement
When a cylinder or flask contains more than 67% of the sample after dilution, nutrients may be limited in the diluted sample and subsequently may reduce biological activity. In these samples, add the nutrient, mineral, and buffer solutions directly to the diluted sample at a rate of 1 mL/L (0.30 mL/300-mL bottle), or use commercially prepared solutions designed to dose the appropriate container size.

Finding
Laboratory staff stated additional nutrients had not been added when more than 200mL of sample had been used (using 300mL bottles).

Records of additional nutrients could not be retrieved.

Laboratory Response
including Root cause
analysis
We have located a source for nutrients suitable for single sample use.

See CAR 10 Response. The estimated shipping date is 09/15/22.

When the nutrients arrive, we will:
• Test to ensure BOD <0.2 mg/L (Zee Hopper)
• Update SOP to include requirement to add nutrient when ≥200 ml sample is added to 300 ml bottle (Cheryl Watson)
• Update BOD Worksheet to include nutrient ID for traceability (Cheryl Watson)
• Document re-training of all BOD analysts (Zee Hopper and Cheryl Watson)
Responsible party in parentheses
Proposed date of completion: October 15, 2022
IAS 1st Response Laboratory response likely to prevent recurrence. ***END OF REPORT***

Laboratory Name: Alpha Analytical Laboratories - Ukiah
Location: 208 Mason Street, Ukiah, CA 95482
ELAP Certificate ID: 1551
Assessment Date(s): July 18 and August 11, 2022
Inspection Type: Renewal! Amendment! Initial # Other #
Assessor(s): Tony Francis and Michelle Barrett-Muir
Assessment Agency: IAS

ACRONYM
Acronyms Used

FULL NAME
2016 TNI The NELAC Institute’s 2016 Standard
CA-NV/AWWA California-Nevada Section - American Water Works Association CCR California Code of Regulations
CWEA California Water Environment Association
DDW Division of Drinking Water
ELAP Environmental Laboratory Accreditation Program
FOA Field of Accreditation
MCL/MRDL Maximum Contaminant Level/Maximum Residual Disinfectant Level OSA On-Site Assessment
PT Proficiency Testing
QM Quality Manual
SOP Standard Operating Procedure
V_M_ Volume _, Module _ of the 2016 TNI standard, revision 2.1 This is a guidance checklist and not a regulation. It does not change or substitute for any legal requirement. While ELAP has made every effort to ensure the accuracy of the items in the checklist, the obligations of the regulated community are determined by the relevant statutes and regulations.

CA ELAP OSA Checklist Approved: 01/07/2021
Version 1.0
California Laboratory Assessment Checklist
2016 TNI Addendum Checklist

DISCLAIMER
CA ELAP OSA Checklist
Version 1.0

Laboratory Changes and Corrections
Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations Previous OSA Review
§ 64802.20
(i)
Has the laboratory implemented corrective actions to
all findings made during the previous OSAs?
X
§ 64814.05 Has the ownership, technical manager, or quality manager changed since the last assessment?
X
If yes, has ELAP been notified of the change? X
Does the laboratory utilize sophisticated
technologies, defined in § 64801.00(v)?
X
§ 64812.05
(e)
If Yes, has the laboratory made a change to its
Sophisticated Technology?
X
If yes, has the laboratory: [(1) – (4)]
§ 64812.05
(e)(1)
Updated the Quality Manual necessitated by the
change of sophisticated technology?
X
§ 64812.05
(e)(2)
Updated or created SOP(s) necessitated by the
change of sophisticated technology?
X
§ 64812.05
(e)(3)
Submitted an amendment application package, if
the sophisticated technology is a new technology
to the laboratory?
X
§ 64812.05
(e)(4)
Retained all records necessary to determine
compliance?
X
CA ELAP OSA Checklist
Version 1.0

General Inspection, Equipment, and Personnel
Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations General
§ 64814.10
(a)
Has the laboratory identified information as a trade
secret?
X
§ 64810.00
(a)
Is the main laboratory a fixed, permanent facility or a fixed-in-place vehicle?
X
Does the laboratory operate a satellite or mobile
laboratory?
X
Multiple
references
If yes, do laboratory reports identify which laboratory performed the analysis?
X
Multiple
references
Were the satellite or mobile laboratory(s) inspected
during this inspection?
X
§ 64802.20
(a)(2)
Does the inspection cover all analytical methods
used for each FOA for which the laboratory seeks to
obtain or maintain accreditation?
X
§ 64802.20
(j)
Did the inspection occur within 6 months from the
initially scheduled assessment date?
X
§ 64802.20
(a)(4)
Has the laboratory violated any ELAP statute or
regulation not listed in this checklist?
X
§ 64812.05 Laboratory Facilities and Equipment
§ 64802.20
(a)(3)
Does the laboratory's instrumentation and equipment
meet the requirements of § 64812.05?
X
§ 64812.05
(a)(1)
Does the Laboratory Facility comply with 2016 TNI
V1M2 §§ 5.3, 5.5, and 5.6
X Fridge temps not recorded on
weekends
§ 64812.05
(c)
General review
only
Does the laboratory store and handle hazardous
materials in accordance with CCR, title 8, division 1,
chapter 4, subchapter 7, General Industry Safety
Orders?
X
§ 64812.05
(d)
General review
only
Does the laboratory dispose of chemical wastes and
maintain records of disposal in accordance with
Health and Safety Code § 25200.3.1, and CCR, title
22, division 4.5, chapter 12, Standards Applicable to
Generators of Hazardous Waste?
X
CA ELAP OSA Checklist
Version 1.0

Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations § 64812.00 Laboratory Personnel
§ 64812.00
(g)
Does the laboratory designate a Quality Manager? X
§ 64812.00
(g)
Does the Quality Manager meet the requirements
and responsibilities of 2016 TNI V1M2 §§ 4.1.5(i),

4.1.7.1, 4.2.6, 4.2.8.2 and 4.14.1?
X
§ 64812.00
(a)
Does the laboratory designate a Technical
Manager?
X
§ 64812.00
(a)(1)
Does the Technical Manager possess at least
baccalaureate degree in chemistry, biochemistry,
biology, microbiology, natural or physical science, or
environmental engineering, sanitary engineering or
chemical engineering?
X
§ 64812.00
(b)
EXCEPTION to
(a)(1)
Does the Technical Manager hold a valid CWEA
Laboratory Analyst certification or CA-NV/AWWA
Water Quality Analyst certification in accordance
with § 64812.00 (b) Table 3?
X
§ 64812.00
(a)(2)
Does the Technical Manager have at least three (3)
years’ experience in the analysis of chemical,
biological, or microbiological samples in an
environmental laboratory, prior to being designated
Technical Manager, subject to allowances in
(a)(2)(A) or (B)?
X
§ 64812.00
(c)(1)
EXCEPTION to
(a)(1) and
(a)(2)
Has the Technical Manager continuously held the
position at an environmental testing laboratory since
the laboratory was first accredited on or before
December 31, 1994?
X
§ 64812.00
(c)(2)
EXCEPTION to
(a)(1) and
(a)(2)
Is the Technical Manager a director of a public
health laboratory, pursuant to Health and Safety
Code §§ 101150 and 101160?
X
§ 64812.00
(d)(1)
Does the Technical Manager comply with 2016 TNI
V1M2 § 4.1.7.2 (except [f])?
X
Sophisticated Technologies
Does the laboratory utilize sophisticated
technologies, defined in § 64801.00(v)?
X
CA ELAP OSA Checklist
Version 1.0

Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations § 64812.00
(j)
Is sophisticated technology in the laboratory
operated by the Technical Manager or other
personnel designated by the Technical Manager?
X
CA ELAP OSA Checklist
Version 1.0

Quality Systems, Records, and Reports
Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations § 64802.20 Quality Systems
§ 64802.20
(b)(1)
Does the laboratory's quality assurance and quality
control procedures meet the requirements of
§ 64802.05?
X
§ 64802.05
(a)(1)
Does the Quality System employed by the laboratory
comply with 2016 TNI V1M2 except § 4.1.7.2(f) and

5.2.6?
X
§ 64802.05
(a)(2)
Does the Quality System employed by the laboratory
comply with 2016 TNI V1M3?
X
§ 64802.05
(a)(2)
Does the Quality System employed by the laboratory
comply with 2016 TNI V1M4?
X pH slope criteria not established
§ 64802.05
(a)(2)
Does the Quality System employed by the laboratory
comply with 2016 TNI V1M5?
X Sterility, volume, sodium thio
not checked. Analyst variability
counts not performed.
§ 64802.05
(a)(2)
Does the Quality System employed by the laboratory
comply with 2016 TNI V1M6?
X
§ 64802.05
(a)(2)
Does the Quality System employed by the laboratory
comply with 2016 TNI V1M7?
X
§ 64812.00
(f)
Does the Quality Manual, or referenced document,
reference that if a Technical Manager is absent
longer than:
(1) Fifteen (15) consecutive days, a person meeting
the qualifications of the Technical Manager shall be
designated to serve as a temporary Technical
Manager; or
(2) Thirty-five (35) consecutive days, ELAP must be
notified in writing.

X
§ 64814.00
(f)(1)
Does the Quality Manual, or referenced document,
contain requirements for subcontractors, compliant
with 2016 TNI V1M2 § 4.5?
X
§ 64802.15 Proficiency Testing Requirements
§ 64802.15
(b)(1)
Does the laboratory comply with 2016 TNI V1M1
except § 5.0 and 8.0?
X
CA ELAP OSA Checklist
Version 1.0

Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations § 64802.15
(n)
Does the Quality Manual, or referenced document,
identify a prohibition on maintaining a financial
interest, familial relationship, or contractual
agreement for consultation with the provider of a PT
study?
X
§ 64802.15
(h)
Does the Quality Manual, or referenced document,
identify after receipt of a “not acceptable” score,
within 45 days the laboratory must:
(1) Notify ELAP of the “Not Acceptable” score;
(2) Document the root cause of the failure;
(3) Take corrective action;
(4) Achieve an acceptable score in a subsequentPT;
(5) Notify ELAP of the “Acceptable” score; and
NOTE: (6) not listed
X
§ 64802.15
(j)
Does the Quality Manual, or referenced document,
identify the procedure upon receipt of a second,
subsequent “not acceptable” score, including:
(1) Notifying ELAP of the “Not Acceptable” result
within three (3) days;
(3) Cease reporting of results for regulatory
purposes for that corresponding FOA;
(4) Notify affected clients of second “Not Acceptable”
PT result by registered mail, email with return
receipt, or electronic signature document;
(5) Within thirty (30) days: investigate and document
the root cause of the failure and take corrective
action;
NOTE: (2) and (6) not listed
X
§ 64814.00 Notification and Reporting
§ 64814.00
(a)
Does the laboratory document any additional State
Regulatory Agencies or federal agencies reporting
requirements?
X
CA ELAP OSA Checklist
Version 1.0

Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations § 64814.00
(b)
Does the Quality Manual, or referenced document,
identify that if an analytical result warrants a client notification, then the notification shall occur after the Technical Manager, or designee, has approved of
the result?
X
§ 64814.00
(h)(1)
Does the laboratory report to its clients in
accordance with 2016 TNI V1M2 § 5.10?
X
§ 64814.00
(n)(1)
Does the laboratory’s record system comply with
2016 TNI V1M2 § 4.13?
X Manual integrations did not
keep original. Temp checks and
critical times not recorded
CA ELAP OSA Checklist
Version 1.0

Specific Requirements for Types of Testing
Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations Drinking Water Specific Requirements
§ 64814.00
(j)
For laboratories testing for bacteria in drinking water, does the laboratory report the results consistent with
DDW requirements?
[ref. 22 CCR § 64423.1(c)(2) & (c)(3)]
X
§ 64814.00
(k)
For laboratories performing chemical, radiological
and microbiological analyses on drinking water
samples, does the laboratory report the results
consistent with the DDW requirements?
[ref. 22 CCR § 64814.00(k)(1) & (2)]
X
§ 64814.00
(l)
Are drinking water results provided to the DDW
before the 10th of the month after completion of
analysis?
X
§ 64814.00
(c)
Does the Quality Manual, or referenced document,
detail procedures when client notification is
required?
X
§ 64814.00
(c)(1)(A)
Are clients notified in 24 hours when the presence of
total or fecal coliforms, or E. coli is confirmed?
X
§ 64814.00
(c)(1)(B)
Are clients notified in 24 hours when a bacterial
sample cannot be reported and must be invalidated
due to interference? [ref. 22 CCR § 64425(b)]
X
§ 64814.00
(c)(1)(C)
Are clients notified in 24 hours when a nitrate sample
exceeds the MCL?
X
§ 64814.00
(c)(1)(D)
Are clients notified in 24 hours when a chlorite
sample result collected at the entry point of a water
distribution system exceeds the MCL?
X
§ 64814.00
(c)(2)(A)
Are clients notified in 48 hours when a perchlorate
sample result exceeds the MCL?
X
§ 64814.00
(c)(2)(B)
Are clients notified in 48 hours when a chlorine
dioxide sample result exceeds the MRDL?
X
§ 64814.00
(c)(2)(C)
Are clients notified in 48 hours when a chlorite
sample result exceeds the MCL?
X
CA ELAP OSA Checklist
Version 1.0

Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations § 64814.00
(d)
Does the Quality Manual, or referenced document,
detail procedures to contact the DDW when clients
cannot be contacted directly within the required
timeframes?
X
§ 64814.00
(f)(2)(E)
When drinking water samples are subcontracted,
does the laboratory provide the required notification
for drinking water testing, unless there is an
arrangement in writing that the subcontractor will
provide the required notification?
X
§ 64814.00
(e)
Does the Quality Manual, or referenced document,
detail procedures when a water supplier requests
invalidation of samples, after reporting the results to the DDW, due to laboratory accident or error,
including: [(1) – (6)]
X
§ 64814.00
(e)(1)
A letter from the Technical Manager to the water
supplier confirming the laboratory accident or error
and agreeing to the invalidation request
X
§ 64814.00
(e)(2)
Complete sample identification, laboratory sample
log number (if used), date and time of collection,
date and time of receipt by the laboratory, date
and time of analysis for the sample(s) in question
X
§ 64814.00
(e)(3)
Complete description of the error alleged to have
invalidated the result(s)
X
§ 64814.00
(e)(4)
Copies of all analytical, operating, and quality
assurance records pertaining to the incident in
question
X
§ 64814.00
(e)(5)
Any observations noted by laboratory personnel
when receiving and analyzing the sample(s) in
question
X
§ 64814.00
(e)(6)
A corrective action plan that contains a root cause
analysis of the laboratory accident or error, the
corrective actions that will take place, and the date
the finding(s) will be corrected.

X
CA ELAP OSA Checklist
Version 1.0

Reference SOP or QM § Does the laboratory comply with this section? Yes No N/A Observations Bioassay Specific Requirements
§ 64802.15
(l)(1)
Does the laboratory achieve acceptable scores in a
PT study, where available, for each FOA for which
the laboratory is requesting accreditation?
X
§ 64802.15
(l)(2)
Does the laboratory Perform reference toxicant tests,
at a minimum, annually for each method, organism,
and endpoint?
X
§ 64802.15
(l)(3)
Does the laboratory plot and maintain control charts
of reference toxicant test results for each method,
organism, and endpoint?
X
1 of 3
TNI 2016 Standard Checklist: Volume 1 Module 2 - Quality System Requirements Citation
Volume 1 Module 2
(V1M2-QS)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 1
Summary of Quality System Requirements - Checklist
responses will determine whether or not these have been met.

You may use any of these items for assessment if you want.

N/A
Alpha Analytical - Ukiah
Reassessmennt and Scope
Expansion, July 18 and
August 11, 2022
V1M2 1 INTRODUCTION, SCOPE AND APPLICABILITY N/A
V1M2 1.1 Introduction N/A
V1M2 1.1
Each laboratory shall have a quality system. The laboratory’s quality system is the means by which an organization ensures the quality of the products or services it provides and includes a variety of management, technical, and administrative elements such as:

X
V1M2 1.1 a) policies and objectives, X
V1M2 1.1 b) procedures and practices, X
V1M2 1.1 c) organizational authority, X
V1M2 1.1 d) responsibilities, and X
V1M2 1.1 e) performance measures. X
V1M2 1.1
The quality system provides the framework for planning, implementing, assessing, and improving work performed by an organization so as to provide the client with data of known and documented quality, sufficient to evaluate the usability of the data to the clients needs. The quality system shall be documented in the laboratory’s quality manual and related quality documentation, and shall be referenced in the quality manual.

X
2 of 3
Citation
Volume 1 Module 2
(V1M2-QS)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 1.1
This Standard contains detailed quality system requirements for consistent and uniform implementation by the laboratories conducting testing and the consistent and uniform evaluation of those laboratories by accreditation bodies. Each laboratory seeking accreditation under this Standard shall ensure that they are implementing their quality system and that all Quality Control procedures specified in this module are being followed. The Quality Assurance policies, which establish quality control procedures, are applicable to environmental laboratories regardless of size and complexity.

X
V1M2 1.1
This Standard is consistent with ISO/IEC 17025:2005
requirements that are relevant to the scope of environmental testing services.

X
V1M2 1.1 All items identified in this document shall be available for an on-site assessment.

X
V1M2 1.2 Scope N/A
V1M2 1.2
The requirements in this document give the basis for a laboratory’s quality system in order to carry out environmental tests. It covers testing performed using reference methods, non-reference methods, and laboratory-developed methods. This document contains the essential elements required to establish a quality system that produces data of known and documented quality, and demonstrates proficiency through the use of proficiency testing and employee training.

X
V1M2 1.2
The general requirements of this document apply to all
organizations performing environmental tests, regardless of the number of personnel or the degree of environmental testing activities. When the use of the data requires compliance with the Standards, these Standards shall be followed.

X
3 of 3
Citation
Volume 1 Module 2
(V1M2-QS)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 1.2
This document is for use by laboratories, clients, regulatory authorities, and accreditation bodies to ensure the laboratory has appropriate management and technical quality systems to perform environmental testing. This document specifies technical, managerial, and documentation requirements needed for
assessment by organizations or accreditation bodies to grant approval.

X
V1M2 1.2
This document provides the requirements needed for laboratory accreditation. If the requirements of this document are met, the laboratory operates a quality system in conformance with the applicable clauses of ISO/IEC 17025:2005. The ISO/IEC
17025:2005 language is incorporated verbatim into this standard, and appears as italicized text.

X
V1M2 1.2
The notes given provide clarification of the text, examples andor guidance. They do not contain requirements and do not form an integral part of this Standard.

X
V1M2 3 Make sure you understand all these terms as they relate to the assessment. N/A
V1M2 3 TERMS AND DEFINITIONS N/A
TNI 2016 Standard Checklist: Volume 1 Module 2 - Management Requirements Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4 MANAGEMENT REQUIREMENTS N/A
V1M2 4.1 Organization (ISO/IEC 17025:2005, Clause 4.1) N/A V1M2 4.1.1 The laboratory or the organization of which it is part shall be an entity that can be held legally responsible. X
V1M2 4.1.2 It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as X
V1M2 4.1.2 to meet the requirements of this International Standard X V1M2 4.1.2 and to satisfy the needs of the customer, the regulatory authorities or organizations providing recognition. X
V1M2 4.1.3
The management system shall cover work carried out in the laboratory's permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities.

X
V1M2 4.1.4
If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.

X
V1M2 4.1.4 N1
NOTE 1: Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory's compliance with the requirements of this International Standard.

N/A
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.1.4 N2
NOTE 2: If the laboratory wishes to be recognized as a thirdparty laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgment. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgment and integrity in relation to its testing or calibration activities.

N/A
V1M2 4.1.5 The laboratory shall: N/A
V1M2 4.1.5 a)
have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including
X
V1M2 4.1.5 a)
have managerial and technical personnel who have the authority and resources needed to carry out the implementation,
maintenance and improvement of the management system,
X
V1M2 4.1.5 a)
have managerial and technical personnel who have the authority and resources needed to identify the occurrence of departures from the management system or from the procedures for
performing tests and/or calibrations
X
V1M2 4.1.5 a)
have managerial and technical personnel who have the authority and resources needed to initiate actions to prevent or minimize such departures (see also 5.2);
X
V1M2 4.1.5 b)
have arrangements to ensure that its management and
personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work;
X
V1M2 4.1.5 c)
have policies and procedures to ensure the protection of its customers' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results;
X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.1.5 d)
have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity;
X
V1M2 4.1.5 e)
define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services; (V1M2 4.2.8.4 e)
N/A
V1M2 4.1.5 f)
specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations;
(V1M2 4.2.8.4 e and 5.2.5)
N/A
V1M2 4.1.5 g)
provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results; (see V1M2 4.2.8.4 e and 5.2.1)
N/A
V1M2 4.1.5 h)
have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations; X
V1M2 4.1.5 i)
Comment: This is different from the actual qualifications of a Quality Manager. Can be determined from the organizational chart, the description of duties, and any documents relating to the selection qualifications and criteria for the position.

N/A
V1M2 4.1.5 i)
appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all ; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources;
X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.1.5 j) appoint deputies for key managerial personnel (see Note);X V1M2 4.1.5 k)
ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system.

X
V1M2 4.1.5 k) N NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. N/A V1M2 4.1.6
Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.

X
V1M2 4.1.7 Additional Requirements for Laboratories N/A V1M2 4.1.7.1 Where staffing is limited, the technical manager and the quality manager may be the same person. N/A
V1M2 4.1.7.1 The laboratory's quality manager and/or his/her designee(s) shall: N/A V1M2 4.1.7.1 See also 4.1.5 i), 4.2.8.2 and 4.14.1 N/A
V1M2 4.1.7.1 a) serve as the focal point for QA/QC and be responsible for the oversight and/or review of quality control data;
X
V1M2 4.1.7.1 b) have functions independent from laboratory operations for which they have quality assurance oversight;
X
V1M2 4.1.7.1 c) be able to evaluate data objectively and perform assessments without outside (e.g., managerial) influence;
X
V1M2 4.1.7.1 d) have documented training and/or experience in QA/QC procedures and the laboratory’s quality system;
X
V1M2 4.1.7.1 e) have a general knowledge of the analytical methods for which data review is performed;
X
V1M2 4.1.7.1 f) arrange for or conduct internal audits as per Section 4.14 annually;
X
V1M2 4.1.7.1 g) notify laboratory management of deficiencies in the quality system; and
X
V1M2 4.1.7.1 h) monitor corrective actions.X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.1.7.2 The laboratory's technical manager(s), however named, and/or his/her designee(s) shall: N/A
V1M2 4.1.7.2 a)
be a member of the staff of an environmental laboratory who exercises actual day-to-day supervision of laboratory operations for the appropriate fields of accreditation and reporting of results; X
V1M2 4.1.7.2 b) be experienced in the fields of accreditation for which the laboratory is seeking accreditation;
X
V1M2 4.1.7.2 c) The laboratory's technical manager(s), however named, and/or his/her designee(s) shall have duties that include: N/A V1M2 4.1.7.2 c) i
• monitoring standards of performance in quality control and quality assurance, and
X
V1M2 4.1.7.2 c) ii • monitoring the validity of the analyses performed and data generated in the laboratory to assure reliable data.

X
V1M2 4.1.7.2 d)
not be the technical manager(s) of more than one accredited environmental laboratory without authorization from the primary Accreditation Body. Circumstances to be considered in the decision to grant such authorization shall include:

X
V1M2 4.1.7.2 d) i • the extent to which operating hours of the laboratories to be directed overlap, N/A
V1M2 4.1.7.2 d) ii • adequacy of supervision in each laboratory, and N/A V1M2 4.1.7.2 d) iii • the availability of environmental laboratory services in the area served. N/A
V1M2 4.1.7.2 e)
if absent for a period of time exceeding fifteen (15) consecutive calendar days shall designate another staff member meeting the qualifications of the technical manager(s) to temporarily perform this function. If this absence exceeds thirty-five (35) consecutive calendar days, the primary accreditation body shall be notified in writing; and
X
V1M2 4.1.7.2 f) meet qualification requirements as specified in Section 5.2.6.1.X V1M2 4.2 Management (ISO/IEC 17025:2005, Clause 4.2) N/A Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.1 The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. X V1M2 4.2.1
The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results.

X
V1M2 4.2.1
The system's documentation shall be communicated to,
understood by, available to, and implemented by the appropriate personnel. (see also V1M2 4.1.6)
X
V1M2 4.2.2 (Quality Policy Elements to be included in the Quality Manual - see V1M2 Section 4.2.8.3 h) N/A
V1M2 4.2.2
The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and
X
V1M2 4.2.2
shall be reviewed during management review. The quality policy statement shall be issued under the authority of top
management. It shall include at least the following:

X
V1M2 4.2.2 a)
the laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its customers;
X
V1M2 4.2.2 b) the management's statement of the laboratory's standard of service; X
V1M2 4.2.2 c) the purpose of the management system related to quality; X V1M2 4.2.2 d)
The quality policy statement shall include a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the quality
documentation and implement the policies and procedures in their work;
X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.2 e)
The quality policy statement shall include the laboratory management's commitment to comply with this International Standard and to continually improve the effectiveness of the management system.

X
V1M2 4.2.2 e) N
NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents.

N/A
V1M2 4.2.3
Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.

X
V1M2 4.2.4
Top management shall communicate to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements.

X
V1M2 4.2.5
The quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the
management system.

X
V1M2 4.2.6
The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.

X
V1M2 4.2.7
Top management shall ensure that the integrity of the
management system is maintained when changes to the
management system are planned and implemented.

X
V1M2 4.2.8 Additional Management System Requirements N/A V1M2 4.2.8.1
The laboratory shall establish and maintain a documented data integrity system. There are four required elements within a data integrity system.

X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.8.1 These are, N/A
V1M2 4.2.8.1 1) Data Integrity training.(see 5.2.7) N/A V1M2 4.2.8.1 2) signed data integrity documentation for all laboratory employees,(see 5.2.7) N/A
V1M2 4.2.8.1 3) periodic in-depth data monitoring X
V1M2 4.2.8.1 4) data integrity procedure documentation (see remainder of

4.2.8.1) N/A
V1M2 4.2.8.1 The data integrity procedures shall be signed and dated by top management
X
V1M2 4.2.8.1
The requirements for data integrity investigation are listed in Section 4.16. The requirements for data integrity training and documentation are listed in Section 5.2.7.

N/A
V1M2 4.2.8.1 Management shall annually review data integrity procedures and update as needed. X
V1M2 4.2.8.1 a)
Laboratory management shall provide a procedure for
confidential reporting of data integrity issues in their laboratory. A primary element of the procedure is to assure confidentiality and a receptive environment in which all employees may privately discuss ethical issues or report items of ethical concern.

X
V1M2 4.2.8.1 b)
In instances of ethical concern, the procedure shall include a process whereby laboratory management is to be informed of the need for any further detailed investigation.

X
V1M2 4.2.8.2 The quality manager shall be responsible for maintaining the currency of the quality manual. X
V1M2 4.2.8.3 The quality manual shall contain: N/A
V1M2 4.2.8.3 a) document title; X
V1M2 4.2.8.3 b) laboratory's full name and address; X
V1M2 4.2.8.3 c) name, address (if different from above), and telephone number of individual(s) responsible for the laboratory; X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.8.3 d)
identification of all major organizational units which are to be covered by this quality manual and the effective date of the version;
X
V1M2 4.2.8.3 e) identification of the laboratory's approved signatories;X V1M2 4.2.8.3 f)
the signed and dated concurrence (with appropriate names and titles), of all responsible parties including the quality manager(s), technical manager(s), and the agent who is in charge of all laboratory activities, such as the laboratory director or laboratory manager;
X
V1M2 4.2.8.3 g) the objectives of the quality system and contain or reference the laboratory’s policies and procedures;
X
V1M2 4.2.8.3 h) See V1M2 4.2.2, 4.2.2 a), b) and c) for specifics to be included in quality policy
f N/A
V1M2 4.2.8.3 h)
the laboratory’s official quality policy statement, which shall include quality system objectives and management’s commitment to ethical laboratory practices and to upholding the requirements of this Standard; and
X
V1M2 4.2.8.3 i) a table of contents, and applicable lists of references, glossaries and appendices.

X
V1M2 4.2.8.4 The quality manual shall contain or reference: N/A V1M2 4.2.8.4 a) all maintenance, calibration and verification procedures used by the laboratory in conducting tests;
X
V1M2 4.2.8.4 b)
major equipment and reference measurement standards used as well as the facilities and services used by the laboratory in conducting tests;
X
V1M2 4.2.8.4 c)
verification practices, which may include inter-laboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes;
X
V1M2 4.2.8.4 d) procedures for reporting analytical results;X V1M2 4.2.8.4 e) See V1M2 4.1.5 e) , f) and g) for specific requirements to be discussed. N/A
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.8.4 e)
the organization and management structure of the laboratory, its place in any parent organization, and relevant organizational charts;
X
V1M2 4.2.8.4 f) See V1M2 4.13 for specifics information to be discussed N/A V1M2 4.2.8.4 f) procedures to ensure that all records required under this Standard are retained, X
V1M2 4.2.8.4 f)
procedures for control and maintenance of documentation through a document control system that ensures that all standard operating procedures (SOPs), manuals, or documents clearly indicate the time period during which the procedure or document was in force;
X
V1M2 4.2.8.4 g) See V1M2 4.1.5 e) for additional information N/A V1M2 4.2.8.4 g) job descriptions of key staff and reference to the job descriptions of other laboratory staff; X
V1M2 4.2.8.4 h) procedures for achieving traceability of measurements; X V1M2 4.2.8.4 i) a list of all methods under which the laboratory performs its accredited testing; X
V1M2 4.2.8.4 j)
procedures for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work;
X
V1M2 4.2.8.4 k) procedures for handling samples; X
V1M2 4.2.8.4 l)
procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur;
X
V1M2 4.2.8.4 m) policy for permitting departures from documented policies and procedures or from standard specifications; X
V1M2 4.2.8.4 n) procedures for dealing with complaints; X V1M2 4.2.8.4 o) procedures for protecting confidentiality (including national security concerns), and proprietary rights; X
V1M2 4.2.8.4 p) procedures for audits and data review; X Citation
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.8.4 q)
procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out and are receiving any needed training; and
X
V1M2 4.2.8.4 r) policy addressing the use of unique electronic signatures, where applicable. X
V1M2 4.2.8.5
Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities, such as assessing data integrity, corrective actions, handling customer complaints, and all methods.

X
V1M2 4.2.8.5 a) These documents, for example, may be equipment manuals provided by the manufacturer, or X
V1M2 4.2.8.5 a)
These documents may be internally written documents with adequate detail to allow someone similarly qualified, other than the analyst, to reproduce the procedures used to generate the test result.

X
V1M2 4.2.8.5 b) The relevant SOPs shall be readily accessible to all personnel. X V1M2 4.2.8.5 c)
Each SOP shall clearly indicate the effective date of the document, the revision number, and the signature(s) of the approving authority.

X
V1M2 4.2.8.5 d)
Documents that contain sufficient information to perform the tests, do not need to be supplemented or rewritten as internal procedures if the documents are written in a way that they can be used as written. Any changes, including the use of a selected option, shall be documented and included in the laboratory’s method records.

X
V1M2 4.2.8.5 e) The laboratory shall have and maintain an SOP for each accredited analyte or method. X
Citation
Volume 1 Module 2
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.8.5 f)
The SOP may be a copy of a published or referenced method or may be written by the laboratory. In cases where modifications to the published method have been made by the laboratory or where the referenced method is ambiguous or provides
insufficient detail, these changes or clarifications shall be clearly described. (4.2.8.5 d))
N/A
V1M2 4.2.8.5 f) Each method shall include or reference the following topics where applicable: N/A
V1M2 4.2.8.5 f) i) identification of the method X
V1M2 4.2.8.5 f) ii) applicable matrix or matrices; X
V1M2 4.2.8.5 f) iii) limits of detection and quantitation ; X V1M2 4.2.8.5 f) iv) scope and application, including analytes to be analyzed; X V1M2 4.2.8.5 f) v) summary of the method; X
V1M2 4.2.8.5 f) vi) definitions; X
V1M2 4.2.8.5 f) vii) interferences; X
V1M2 4.2.8.5 f) viii) safety; X
V1M2 4.2.8.5 f) ix) equipment and supplies; X
V1M2 4.2.8.5 f) x) reagents and standards; X
V1M2 4.2.8.5 f) xi) sample collection, preservation, shipment and storage; X V1M2 4.2.8.5 f) xii) quality control; X
V1M2 4.2.8.5 f) xiii) calibration and standardization; X V1M2 4.2.8.5 f) xiv) procedure; X
V1M2 4.2.8.5 f) xv) data analysis and calculations; X
V1M2 4.2.8.5 f) xvi) method performance; X
V1M2 4.2.8.5 f) xvii) pollution prevention; X
V1M2 4.2.8.5 f) xviii) data assessment and acceptance criteria for quality control measures;
X
V1M2 4.2.8.5 f) xix) corrective actions for out-of-control data; X V1M2 4.2.8.5 f) xx) contingencies for handling out-of-control or unacceptable data; X V1M2 4.2.8.5 f) xxi) waste management; X
V1M2 4.2.8.5 f) xxii) references; and X
Citation
Volume 1 Module 2
(V1M2 -
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.2.8.5 f) xxiii) any tables, diagrams, flowcharts and validation data. X V1M2 4.3 Document Control (ISO/IEC 17025:2005, Clause 4.3) N/A V1M2 4.3.1 General N/A
V1M2 4.3.1
The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.

X
V1M2 4.3.1 N1
NOTE 1: In this context "document" could be policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc.

These may be on various media, whether hard copy or electronic, and they may be digital, analog, photographic or written.

N/A
V1M2 4.3.1 N2 NOTE 2: The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.13. N/A V1M2 4.3.2 Document Approval and Issue N/A
V1M2 4.3.2.1
All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue.

X
V1M2 4.3.2.1
A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established and shall be readily available to preclude the use of invalid and/or obsolete documents.

X
V1M2 4.3.2.2 The document procedure(s) adopted shall ensure that: N/A V1M2 4.3.2.2 a)
authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;
X
Citation
Volume 1 Module 2
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.3.2.2 b)
documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements;
X
V1M2 4.3.2.2 c)
invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;
X
V1M2 4.3.2.2 d) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked. X
V1M2 4.3.2.3 Management system documents generated by the laboratory shall be uniquely identified. X
V1M2 4.3.2.3
Management system document identification shall include the date of issue and/or revision identification, page numbering, the total number of pages or a mark to signify the end of the document, and the issuing authority(ies).

X
V1M2 4.3.3 Document Changes N/A
V1M2 4.3.3.1
Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise.

X
V1M2 4.3.3.1
The designated personnel shall have access to pertinent background information upon which to base their review and approval.

X
V1M2 4.3.3.2 Where practicable, the altered or new text shall be identified in the document or the appropriate attachments. X
V1M2 4.3.3.3
If the laboratory's document control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined.

X
V1M2 4.3.3.3 Amendments shall be clearly marked, initialled and dated. X V1M2 4.3.3.3 A revised document shall be formally re-issued as soon as practicable. X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.3.3.4
Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled.

X
V1M2 4.4 Review of Requests, Tenders and Contracts (ISO/IEC 17025:2005, Clause 4.4) N/A
V1M2 4.4.1 The laboratory shall establish and maintain procedures for the review of requests, tenders and contracts. (4.4.1 a) through c) N/A V1M2 4.V1M2 4.1 a)
The policies and procedures for the review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that: the requirements, including the methods to be used, are adequately defined, documented and understood (see

5.4.2);
X
V1M2 4.V1M2 4.1 b)
The policies and procedures for the review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that: the laboratory has the capability and resources to meet the requirements;
X
V1M2 4.V1M2 4.1 c)
The policies and procedures for he review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that: the appropriate test and/or calibration method is selected and is capable of meeting the customers'
requirements (see 5.4.2).

X
V1M2 4.V1M2 4.1 c)
Any differences between the request or tender and the contract shall be resolved before any work commences. Each contract shall be acceptable both to the laboratory and the customer.

X
V1M2 4.V1M2 4.1 c)
N1
NOTE 1: The request, tender and contract review should be conducted in a practical and efficient manner, and the effect of financial, legal and time schedule aspects should be taken into account. For internal customers, reviews of requests, tenders and contracts can be performed in a simplified way.

N/A
Citation
Volume 1 Module 2
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.V1M2 4.1 c)
N2
NOTE 2: The review of capability should establish that the laboratory possesses the necessary physical, personnel and information resources, and that the laboratory's personnel have the skills and expertise necessary for the performance of the tests and/or calibrations in question. The review may also encompass results of earlier participation in interlaboratory comparisons or proficiency testing and/or the running of trial test or calibration programmes using samples or items of known value in order to determine uncertainties of measurement, limits of detection, confidence limits, etc.

N/A
V1M2 4.4.1 c) N3 NOTE 3: A contract may be any written or oral agreement to provide a customer with testing and/or calibration services. N/A V1M2 4.4.2 Records of the review of requests, tenders and contracts, including any significant changes, shall be maintained. X V1M2 4.4.2
Records shall also be maintained of pertinent discussions with a customer relating to the customer's requirements or the results of the work during the period of execution of the contract.

X
V1M2 4.4.2 N
NOTE: For review of routine and other simple tasks, the date and the identification (e.g. the initials) of the person in the laboratory responsible for carrying out the contracted work are considered adequate. For repetitive routine tasks, the review need be made only at the initial enquiry stage or on granting of the contract for on-going routine work performed under a general agreement with the customer, provided that the customer's requirements remain unchanged. For new, complex or advanced testing and/or
calibration tasks, a more comprehensive record should be maintained.

N/A
V1M2 4.4.3 The review of requests, tenders and contracts shall also cover any work that is subcontracted by the laboratory. X
Citation
Volume 1 Module 2
(V1M2 -
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.4.4 The customer shall be informed of any deviation from the contract. X
V1M2 4.4.5
If a contract needs to be amended after work has commenced, the same contract review process shall be repeated and any amendments shall be communicated to all affected personnel.

X
V1M2 4.5 Subcontracting of Environmental Tests (ISO/IEC 17025:2005, Clause 4.5) N/A
V1M2 4.5.1
When a laboratory subcontracts work, whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question.

N/A
V1M2 4.5.2
The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.

X
V1M2 4.5.3
The laboratory is responsible to the customer for the
subcontractor's work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used.

X
V1M2 4.5.4
The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question.

X
V1M2 4.5.5
When a laboratory subcontracts work, this work shall be placed with a laboratory accredited to this Standard for the tests to be performed or with a laboratory that meets applicable statutory and regulatory requirements for performing the tests and submitting the results of tests performed.

X
Citation
Volume 1 Module 2
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.5.5 The laboratory performing the subcontracted work shall be indicated in the final report.

X
V1M2 4.5.5 The laboratory shall make a copy of the subcontractor’s report available to the client when requested.

X
V1M2 4.6 Purchasing Services and Supplies (ISO/IEC 17025:2005, Clause

4.6) N/A
V1M2 4.6.1
The laboratory shall have a policy and procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations.

X
V1M2 4.6.1
Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations.

X
V1M2 4.6.2
The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned.

X
V1M2 4.6.2 These services and supplies used shall comply with specified requirements.

X
V1M2 4.6.2 Records of actions taken to check compliance of services and supplies shall be maintained.

X
V1M2 4.6.3
Purchasing documents for items affecting the quality of laboratory output shall contain data describing the services and supplies ordered.

X
V1M2 4.6.3 These purchasing documents shall be reviewed and approved for technical content prior to release.

X
Citation
Volume 1 Module 2
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.6.3 N
NOTE: The description may include type, class, grade, precise identification, specifications, drawings, inspection instructions, other technical data including approval of test results, the quality required and the management system standard under which they were made.

N/A
V1M2 4.6.4
The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration,
X
V1M2 4.6.4
The laboratory shall maintain records of the evaluation suppliers of critical consumables, supplies and services and list those approved.

X
V1M2 4.7 Service to the Client (ISO/IEC 17025:2005, Clause 4.7) N/A V1M2 4.7.1
The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer's request and in monitoring the laboratory's performance in relation to the work performed, provided that the laboratory ensures confidentiality to other customers.

X
V1M2 4.7.1 N1 NOTE 1: Such cooperation may include: N/A V1M2 4.7.1 N1 a)
providing the customer or the customer's representative reasonable access to relevant areas of the laboratory for the witnessing of tests and/or calibrations performed for the customer;
N/A
V1M2 4.7.1 N1 b) preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes. N/A V1M2 4.7.1 N2
NOTE 2: Customers value the maintenance of good
communication, advice and guidance in technical matters, and opinions and interpretations based on results. Communication with the customer, especially in large assignments, should be maintained throughout the work. The laboratory should inform the customer of any delays or major deviations in the
performance of the tests and/or calibrations.

N/A
Citation
Volume 1 Module 2
(V1M2 -
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.7.2 The laboratory shall seek feedback, both positive and negative, from its customers. X
V1M2 4.7.2
The feedback shall be used and analysed to improve the
management system, testing and calibration activities and customer service.

X
V1M2 4.7.2 N
NOTE: Examples of the types of feedback include customer satisfaction surveys and review of test or calibration reports with customers.

N/A
V1M2 4.8 Complaints (ISO/IEC 17025:2005, Clause 4.8) N/A V1M2 4.8 The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. X V1M2 4.8
Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11).

X
V1M2 4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005, Clause 4.9) N/A
V1M2 4.9.1
The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer.

X
V1M2 4.9.1 The policy and procedures shall ensure that: N/A V1M2 4.9.1 a)
the responsibilities and authorities for the management of nonconforming work are designated and actions (including halting of work and withholding of test reports and calibration certificates, as necessary) are defined and taken when
nonconforming work is identified;
X
V1M2 4.9.1 b) an evaluation of the significance of the nonconforming work is made; X
V1M2 4.9.1 c) correction is taken immediately, together with any decision about the acceptability of the nonconforming work; X
Citation
Volume 1 Module 2
(V1M2 -
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.9.1 d) where necessary, the customer is notified and work is recalled; X V1M2 4.9.1 e) the responsibility for authorizing the resumption of work is defined. X
V1M2 4.9.1 e) N
NOTE: Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits.

N/A
V1M2 4.9.2
Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 shall be promptly followed.

X
V1M2 4.1 Improvement (ISO/IEC 17025:2005, Clause 4.10) N/A V1M2 4.1
The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

X
V1M2 4.11 Corrective Action (ISO/IEC 17025:2005, Clause 4.11) N/A V1M2 4.11.1 General N/A
V1M2 4.11.1
The laboratory shall establish a policy and a procedure for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.

X
Citation
Volume 1 Module 2
(V1M2 -
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.11.1
The laboratory shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.

X
V1M2 4.11.1 N
NOTE: A problem with the management system or with the
technical operations of the laboratory may be identified through a variety of activities, such as control of nonconforming work, internal or external audits, management reviews, feedback from customers and from staff observations.

N/A
V1M2 4.11.2 Cause Analysis N/A
V1M2 4.11.2 The procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem. X V1M2 4.11.2 N
NOTE: Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include customer requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration.

N/A
V1M2 4.11.3 Selection and Implementation of Corrective Actions N/A V1M2 4.11.3 Where corrective action is needed, the laboratory shall identify potential corrective actions X
V1M2 4.11.3 It shall select and implement the action(s) most likely to eliminate the problem and to prevent recurrence. X
V1M2 4.11.3 Corrective actions shall be to a degree appropriate to the magnitude and the risk of the problem. X
V1M2 4.11.3 The laboratory shall document and implement any required changes resulting from corrective action investigations. X V1M2 4.11.4 Monitoring of Corrective Actions N/A
Citation
Volume 1 Module 2
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.11.4 The laboratory shall monitor the results to ensure that the corrective actions taken have been effective. X
V1M2 4.11.5 Additional Audits N/A
V1M2 4.11.5
Where the identification of nonconformities or departures casts doubts on the laboratory's compliance with its own policies and procedures, or on its compliance with this International Standard, the laboratory shall ensure that the appropriate areas of activity are audited in accordance with 4.14 as soon as possible.

X
V1M2 4.11.5 N
NOTE: Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness. An additional audit should be necessary only when a serious issue or risk to the business is identified.

N/A
V1M2 4.11.6 The laboratory shall have documented procedure(s) to address

4.11.1 (see 4.11.1) N/A
V1M2 4.11.6 The laboratory shall have documented procedure(s) to address

4.11.3 N/A
V1M2 4.11.6 The laboratory shall have documented procedure(s) to address

4.11.4 N/A
V1M2 4.11.6 The laboratory shall have documented procedure(s) to address

4.11.5 N/A
V1M2 4.11.6 a) These procedure(s) shall also include: which individual(s) or positions are responsible for assessing each QC data type; and X V1M2 4.11.6 b)
These procedure(s) shall also include: which individual(s) or positions are responsible for initiating and/or recommending corrective actions.

X
V1M2 4.11.7 Cause analysis described in 4.11.2 applies to failures that indicate a systematic error. X
V1M2 4.12 Preventive Action (ISO/IEC 17025:2005, Clause 4.12) N/A Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.12.1
Needed improvements and potential sources of nonconformities, either technical or concerning the management system, shall be identified.

X
V1M2 4.12.1
When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement.

X
V1M2 4.12.2
Procedures for preventive actions shall include the initiation of such actions and the application of controls to ensure that they are effective.

X
V1M2 4.12.2 N1
NOTE 1: Preventive action is a pro-active process to identify opportunities for improvement rather than a reaction to the identification of problems or complaints.

N/A
V1M2 4.12.2 N2
NOTE 2: Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results.

N/A
V1M2 4.13 Control of Records (ISO/IEC 17025:2005, Clause 4.13) N/A V1M2 4.13.1 General N/A
V1M2 4.13.1.1
The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records.

X
V1M2 4.13.1.1
Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions.

X
V1M2 4.13.1.2
All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or
deterioration and to prevent loss.

X
V1M2 4.13.1.2 Retention times of records shall be established. X Citation
Volume 1 Module 2
(V1M2 -
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.13.1.2 N NOTE: Records may be in any media, such as hard copy or electronic media. N/A
V1M2 4.13.1.3 All records shall be held secure and in confidence. X V1M2 4.13.1.4 The laboratory shall have procedures to protect and back-up records stored electronically X
V1M2 4.13.1.4 The laboratory shall have procedures to prevent unauthorized access to or amendment of these records. X
V1M2 4.13.2 Technical Records N/A
V1M2 4.13.2.1
The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period.

X Manual integrations did not
retain the original records
V1M2 4.13.2.1
The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original.(4.13.3 f)
X N/A
V1M2 4.13.2.1
The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.

X
V1M2 4.13.2.1 N1 NOTE 1: In certain fields it may be impossible or impractical to retain records of all original observations. N/A
V1M2 4.13.2.1 N2
NOTE 2: Technical records are accumulations of data (see 5.4.7) and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, customers' notes, papers and feedback.

N/A
Citation
Volume 1 Module 2
(V1M2 -
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Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.13.2.2 Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task. X V1M2 4.13.2.3
When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside.

X
V1M2 4.13.2.3 All such alterations to records shall be signed or initialled by the person making the correction. X
V1M2 4.13.2.3 In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data. X V1M2 4.13.3 Additional Requirements N/A
V1M2 4.13.3 a)
The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation.

X
V1M2 4.13.3 a)
This system shall produce unequivocal, accurate records that document all laboratory activities such as laboratory facilities, equipment, analytical methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification, and inter-laboratory transfers of samples and/or extracts.

X
V1M2 4.13.3 b) The laboratory shall retain all records for a minimum of five years from generation of the last entry in the records. X
V1M2 4.13.3 c) Records shall be available to the accreditation body. X V1M2 4.13.3 d)
Records that are stored only on electronic media shall be supported by the hardware and software necessary for their retrieval.

X
V1M2 4.13.3 e) Access to archived information shall be documented with an access log. X
V1M2 4.13.3 f) All information necessary for the historical reconstruction of data shall be maintained by the laboratory. X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.13.3 f) Historical reconstruction information shall include N/A V1M2 4.13.3 f) i
all raw data, whether hard copy or electronic, for calibrations, samples and quality control measures, including analysts’ worksheets and data output records (chromatograms, strip charts, and other instrument response readout records);
X
V1M2 4.13.3 f) ii
a written description or reference to the specific test method used, which includes a description of the specific computational steps used to translate parametric observations into a reportable analytical value;
X
V1M2 4.13.3 f) iii laboratory sample ID code; X
V1M2 4.13.3 f) iv date of analysis; X
V1M2 4.13.3 f) v time of analysis is required if the holding time is seventy-two hours or less X
V1M2 4.13.3 f) v time of analysis is required when time critical steps are included in the analysis (e.g., extractions and incubations); X solids time not recroded V1M2 4.13.3 f) vi instrumentation identification and instrument operating conditions/parameters (or reference to such data); X Thermometer not listed V1M2 4.13.3 f) vii all manual calculations; X
V1M2 4.13.3 f) viii analyst's or operator's initials/signature or electronic identification; X V1M2 4.13.3 f) ix
sample preparation, including cleanup, separation protocols, incubation periods or subculture, ID codes, volumes, weights, instrument printouts, meter readings, calculations, reagents; X
V1M2 4.13.3 f) x test results; X
V1M2 4.13.3 f) xi standard and reagent origin, receipt, preparation, and use; X V1M2 4.13.3 f) xii calibration criteria, frequency and acceptance criteria; X V1M2 4.13.3 f) xiii data and statistical calculations, review, confirmation, interpretation, assessment and reporting conventions; X V1M2 4.13.3 f) xiv quality control protocols and assessment; X Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.13.3 f) xv
electronic data security, software documentation and verification, software and hardware audits, backups, and records of any changes to automated data entries;
X
V1M2 4.13.3 f) xvi method performance criteria including expected quality control requirements; X
V1M2 4.13.3 f) xvii proficiency test results; X
V1M2 4.13.3 f) xviii records of demonstration of capability for each analyst; and X V1M2 4.13.3 f) xix a record of names, initials, and signatures for all individuals who are responsible for signing or initialing any laboratory record. X V1M2 4.13.3 g
All generated data, except those that are generated by
automated data collection systems, shall be recorded legibly in permanent ink.

X
V1M2 4.13.3 g i i. An individual making corrections to records shall date and initial the correction. X
V1M2 4.13.3 g ii ii. Corrections due to reasons other than transcription errors shall specify the reason for the correction. X
V1M2 4.13.3 h
The laboratory shall have a plan to ensure that the records are maintained or transferred according to the clients’ instructions in the event that a laboratory transfers ownership or goes out of business.

X
V1M2 4.13.3 h In addition, appropriate regulatory and state legal requirements concerning laboratory records shall be followed. X
V1M2 4.14 Internal Audits (ISO/IEC 17025:2005, Clause 4.14) N/A V1M2 4.14.1
The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and this
International Standard.

X
V1M2 4.14.1
The internal audit programme shall address all elements of the management system, including the testing and/or calibration activities.

X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.14.1
It is the responsibility of the quality manager to plan and organize audits as required by the schedule and requested by management.

X
V1M2 4.14.1
Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.

X
V1M2 4.14.1 N NOTE: The cycle for internal auditing should normally be completed in one year. N/A
V1M2 4.14.2
When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory shall take timely corrective action
X
V1M2 4.14.2
When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory notify customers in writing if investigations show that the laboratory results may have been affected.

X
V1M2 4.14.3 The area of activity audited, the audit findings and corrective actions that arise from them shall be recorded. X
V1M2 4.14.4 Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken. X V1M2 4.14.5 Additional Items N/A
V1M2 4.14.5 a)
The laboratory shall have a policy that specifies the time frame for notifying a client of events that cast doubt on the validity of the results.

X
V1M2 4.14.5 b) The laboratory management shall ensure that these actions are discharged within the agreed time frame. X
V1M2 4.14.5 c) The Internal audit schedule shall be completed annually, X V1M2 4.15 Management Reviews (ISO/IEC 17025:2005, Clause 4.15) N/A Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.15.1
In accordance with a predetermined schedule and procedure, the laboratory's top management shall periodically conduct a review of the laboratory's management system and testing and/or calibration activities to ensure their continuing suitability and effectiveness
X
V1M2 4.15.1
In accordance with a predetermined schedule and procedure, the laboratory's top management shall periodically conduct a review of the laboratory's management system and testing and/or calibration activities to introduce necessary changes or improvements.

X
V1M2 4.15.1 -The management review shall take account of: the suitability of policies and procedures;
X
V1M2 4.15.1 -The management review shall take account of: reports from managerial and supervisory personnel;
X
V1M2 4.15.1 -The management review shall take account of: the outcome of recent internal audits;
X
V1M2 4.15.1 -The management review shall take account of: corrective and preventive actions;
X
V1M2 4.15.1 -The management review shall take account of: assessments by external bodies;
X
V1M2 4.15.1 -The management review shall take account of: the results of interlaboratory comparisons or proficiency tests;
X
V1M2 4.15.1 -The review shall take account of: changes in the volume and type of the work;
X
V1M2 4.15.1 -The management review shall take account of: customer feedback;
X
V1M2 4.15.1 -The management review shall take account of: complaints;X V1M2 4.15.1 -The management review shall take account of:
recommendations for improvement;
X
Citation
Volume 1 Module 2
(V1M2 -
Management)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 4.15.1
-The management review shall take account of: other relevant factors, such as quality control activities, resources, and staff training.

X
V1M2 4.15.1 N1 NOTE 1: A typical period for conducting a management review is once every 12 months. N/A
V1M2 4.15.1 N2
NOTE 2: Results should feed into the laboratory planning system and should include the goals, objectives and action plans for the coming year.

N/A
V1M2 4.15.1 N3 NOTE 3: A management review includes consideration of related subjects at regular management meetings. N/A
V1M2 4.15.2 Findings from management reviews and the actions that arise from them shall be recorded.

X
V1M2 4.15.2 The management shall ensure that those actions are carried out within an appropriate and agreed timescale.

X
V1M2 4.15.3 Management review shall be completed on an annual basis.X V1M2 4.16 Data Integrity Investigations N/A
V1M2 4.16 All investigations resulting from data integrity issues should be conducted in a confidential manner until they are completed.

X
V1M2 4.16 These investigations shall be documented as well as any notifications made to clients receiving any affected data.

X
TNI 2016 Standard Checklist: Volume 1 Module 2 - Technical Requirements Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V!M2 5 TECHNICAL REQUIREMENTS N/A
V1M2 5.1.1 General (ISO/IEC 17025:2005, Clause 5.1) N/A V1M2 5.1.1
Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from:

N/A
V1M2 5.1.1 - human factors (5.2); N/A
V1M2 5.1.1 - accommodation and environmental conditions (5.3); N/A V1M2 5.1.1 - test and calibration methods and method validation (5.4); N/A V1M2 5.1.1 - equipment (5.5); N/A
V1M2 5.1.1 - measurement traceability (5.6); N/A
V1M2 5.1.1 - sampling (5.7); N/A
V1M2 5.1.1 - the handling of test and calibration items (5.8). N/A V1M2 5.1.2
The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests and between (types of) calibrations.

N/A
V1M2 5.1.2
The laboratory shall take account of these factors (V1M2 5.1.1) in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

X
V1M2 5.2 Personnel (ISO/IEC 17025:2005, Clause 5.2) N/A V1M2 5.2.1
The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. (See Section 1.6 of the technical modules)
N/A
V1M2 5.2.1 When using staff who are undergoing training, appropriate supervision shall be provided. X
V1M2 5.2.1
Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or
demonstrated skills, as required.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.1 N1
NOTE 1: In some technical areas (e.g. non-destructive testing) it may be required that the personnel performing certain tasks hold personnel certification. The laboratory is responsible for fulfilling specified personnel certification requirements. The requirements for personnel certification might be regulatory, included in the standards for the specific technical field, or required by the customer.

N/A
V1M2 5.2.1 N2
NOTE 2: The personnel responsible for the opinions and
interpretation included in test reports should, in addition to the appropriate qualifications, training, experience and satisfactory knowledge of the testing carried out, also have:

N/A
V1M2 5.2.1 N2
— relevant knowledge of the technology used for the
manufacturing of the items, materials, products, etc. tested, or the way they are used or intended to be used, and of the defects or degradations which may occur during or in service;
N/A
V1M2 5.2.1 N2 — knowledge of the general requirements expressed in the legislation and standards; and N/A
V1M2 5.2.1 N2
— an understanding of the significance of deviations found with regard to the normal use of the items, materials, products, etc. concerned.

N/A
V1M2 5.2.2
The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel.

X
V1M2 5.2.2 The laboratory shall have a policy and procedures for identifying training needs and providing training of personnel. X
V1M2 5.2.2 The training programme shall be relevant to the present and anticipated tasks of the laboratory. X
V1M2 5.2.2 The effectiveness of the training actions taken shall be evaluated. X V1M2 5.2.3 The laboratory shall use personnel who are employed by, or under contract to, the laboratory. X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.3
Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's management system.

X
V1M2 5.2.4
The laboratory shall maintain current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations.

X
V1M2 5.2.4 N NOTE: Job descriptions can be defined in many ways. As a minimum, the following should be defined: N/A
V1M2 5.2.4 N — the responsibilities with respect to performing tests and/or calibrations; N/A
V1M2 5.2.4 N — the responsibilities with respect to the planning of tests and/or calibrations and evaluation of results; N/A
V1M2 5.2.4 N — the responsibilities for reporting opinions and interpretations; N/A V1M2 5.2.4 N — the responsibilities with respect to method modification and development and validation of new methods; N/A
V1M2 5.2.4 N — expertise and experience required; N/A
V1M2 5.2.4 N — qualifications and training programmes; N/A V1M2 5.2.4 N — managerial duties. N/A
V1M2 5.2.5
The management shall authorize specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment.

X
V1M2 5.2.5
The laboratory shall maintain records of the relevant
authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel.

X
V1M2 5.2.5 This information shall be readily available and shall include the date on which authorization and/or competence is confirmed.

X
V1M2 5.2.5 All references to Calibration Certificates in ISO/IEC 17025:2005 are not applicable to environmental testing. N/A
V1M2 5.2.6 Additional Personnel Requirements N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.6.1 Technical Manager Qualifications N/A
V1M2 5.2.6.1 The applicable requirements for technical managers are given below. N/A
V1M2 5.2.6.1 a)
Any technical manager of an accredited environmental laboratory engaged in chemical analysis shall be a person with a bachelor’s degree in the chemical, environmental, biological sciences, physical sciences or engineering,
X
V1M2 5.2.6.1 a)
Any technical manager of an accredited environmental laboratory engaged in chemical analysis shall have at least twenty-four college (24) semester credit hours in chemistry
X
V1M2 5.2.6.1 a)
Any technical manager of an accredited environmental laboratory engaged in chemical analysis shall have at least two (2) years of experience in the environmental analysis of representative inorganic and organic analytes for which the laboratory seeks or maintains accreditation. A master’s or doctoral degree in one of the above disciplines may be substituted for one year of experience.

X
V1M2 5.2.6.1 b)
Any technical manager of an accredited environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall be a person with at least an earned associate's degree in the chemical, physical or environmental sciences, or two (2) years of equivalent and successful college education,
X
V1M2 5.2.6.1 b)
Any technical manager of an accredited environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall have a minimum of sixteen (16) college semester credit hours in chemistry.

X
V1M2 5.2.6.1 b)
Any technical manager of an accredited environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall have at least two (2) years of experience performing such analysis.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.6.1 c)
Any technical manager of an accredited environmental laboratory engaged in microbiological or biological analysis shall be a person with a bachelor’s degree in microbiology, biology, chemistry, environmental sciences, physical sciences or engineering X
V1M2 5.2.6.1 c)
Any technical manager of an accredited environmental laboratory engaged in microbiological or biological analysis shall have a minimum of sixteen college semester credit hours in general microbiology and biology
X
V1M2 5.2.6.1 c)
Any technical manager of an accredited environmental laboratory engaged in microbiological or biological analysis shall have at least two (2) years of experience in the environmental analysis of representative analytes for which the laboratory seeks or maintains accreditation. A master’s or doctoral degree in one of the above disciplines may be substituted for one (1) year of experience.

X
V1M2 5.2.6.1 c)
A person with an associate's degree in an appropriate field of the sciences or applied sciences, with a minimum of four (4) college semester credit hours in general microbiology may be the technical manager(s) of a laboratory engaged in microbiological analysis limited to fecal coliform, total coliform, E. coli, and standard plate count. Two (2) years of equivalent and successful college education, including the microbiology requirement, may be substituted for the associate's degree.

X
V1M2 5.2.6.1 c)
the technical manager(s) of a laboratory engaged in
microbiological analysis limited to fecal coliform, total coliform, E. coli, and standard plate count shall have one (1) year of experience in microbiological analyses.

X
V1M2 5.2.6.1 d)
Any technical manager of an accredited environmental laboratory engaged in radiological analysis shall be a person with a bachelor’s degree in chemistry, environmental, biological sciences, physical sciences or engineering
X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.6.1 d)
Any technical manager of an accredited environmental laboratory engaged in radiological analysis shall have twenty-four (24) college semester credit hours of chemistry
X
V1M2 5.2.6.1 d)
Any technical manager of an accredited environmental laboratory engaged in radiological analysis shall have two (2) or more years of experience in the radiological analysis of environmental samples. A master’s or doctoral degree in one of the above disciplines may be substituted for one (1) year experience.

X
V1M2 5.2.6.1 e)
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers shall meet the following requirements:

X
V1M2 5.2.6.1 e) i
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a transmission electron microscope shall have a bachelor's degree
X
V1M2 5.2.6.1 e) i
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a transmission electron microscope shall have successfully completed of courses in the use of the instrument
X
V1M2 5.2.6.1 e) i
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a transmission electron microscope shall have one (1) year of experience, under supervision, in the use of the instrument. Such experience shall include the identification of minerals.

X
V1M2 5.2.6.1 e) ii
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a polarized light microscope, shall have an associate's degree or two (2) years of college study X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.6.1 e) ii
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a polarized light microscope, shall have successfully completed formal coursework in polarized light microscopy
X
V1M2 5.2.6.1 e) ii
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a polarized light microscope, shall have one year of experience, under supervision, in the use of the instrument. Such experience shall include the identification of minerals.

X
V1M2 5.2.6.1 e) iii
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a phase contrast microscope, as in the determination of airborne fibers, shall have an associate's degree or two (2) years of college study
X
V1M2 5.2.6.1 e) iii
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a phase contrast microscope, as in the determination of airborne fibers, shall have
documentation of successful completion of formal coursework in phase contrast microscopy
X
V1M2 5.2.6.1 e) iii
The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a phase contrast microscope, as in the determination of airborne fibers, shall have one (1) year of experience, under supervision, in the use of the instrument.

X
V1M2 5.2.6.1 f)
Any technical manager of an accredited environmental laboratory engaged in the examination of radon in air shall have at least an associate’s degree or two (2) years of college
X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.6.1 f)
Any technical manager of an accredited environmental laboratory engaged in the examination of radon in air shall have at least one (1) year of experience in radiation measurements
X
V1M2 5.2.6.1 f)
Any technical manager of an accredited environmental laboratory engaged in the examination of radon in air shall have at least one (1) year of experience in the measurement of radon and/or radon progeny.

X
V1M2 5.2.6.2 Technical Manager Qualification Exceptions N/A V1M2 5.2.6.2 a)
Notwithstanding any other provision of this Section, a full-time employee of a drinking water or sewage treatment facility who holds a valid treatment plant operator's certificate appropriate to the nature and size of such facility shall be deemed to meet the educational requirements as the technical manager.

X
V1M2 5.2.6.2 a)
A technical manager shall have two (2) year testing experience devoted exclusively to the testing of environmental samples specified in the scope of the facility’s regulatory permit.

X
V1M2 5.2.6.2 a)
Such accreditation for a water treatment facility and/or a sewage treatment facility shall be limited to the scope of that facility’s regulatory permit.

X
V1M2 5.2.6.2 b)
A full-time employee of an industrial waste treatment facility with a minimum of two (2) years of experience under supervision in testing of environmental samples taken within such facility for the scope of that facility’s regulatory permit shall be deemed to meet the requirements for serving as the technical manager of an accredited laboratory.

X
V1M2 5.2.6.2 b) Such accreditation for an industrial waste treatment facility shall be limited to the scope of that facility’s regulatory permit. X V1M2 5.2.6.2 c)
Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall qualify as technical manager(s) subject to the following conditions.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.6.2 c) i
Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall qualify as technical manager(s) if the person shall be a technical manager of the laboratory on the date the laboratory applies for accreditation and/or becomes subject to accreditation under this Standard X
V1M2 5.2.6.2 c) i
Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall qualify as technical manager(s) if the person shall have been a technical manager in that laboratory continuously for the previous twelve (12) months or more.

X
V1M2 5.2.6.2 c) ii
Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall be approved as a technical manager for only those fields of accreditation for which he/she has been technical manager in that laboratory for the previous twelve (12) months or more.

X
V1M2 5.2.6.2 c) iii
A person who is admitted as a technical manager under these conditions, and leaves the laboratory, will be eligible for hire as a technical manager for the same fields of accreditation in another accredited laboratory.

X
V1M2 5.2.7 Data Integrity Training N/A
V1M2 5.2.7
Data integrity training shall be provided as a formal part of new employee orientation and shall also be provided on an annual basis for all current employees.

X
V1M2 5.2.7
Employees are required to understand that any infractions of the laboratory data integrity procedures shall result in a detailed investigation that could lead to very serious consequences including immediate termination, debarment or civil/criminal prosecution.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.2.7
The initial data integrity training and the annual refresher training shall have a signature attendance sheet or other form of documentation that demonstrates all staff have participated and understand their obligations related to data integrity.

X
V1M2 5.2.7
Data integrity training requires emphasis on the importance of proper written narration on the part of the analyst with respect to those cases where analytical data may be useful, but are in one sense or another partially deficient
X
V1M2 5.2.7 The topics covered in such training shall be documented in writing (such as an agenda) and provided to all trainees. X
V1M2 5.2.7 At a minimum, the following topics and activities shall be included: N/A V1M2 5.2.7.a
organizational mission and its relationship to the critical need for honesty and full disclosure in all analytical reporting, how and when to report data integrity issues, and record keeping; X
V1M2 5.2.7.b training, including discussion regarding all data integrity procedures; X
V1M2 5.2.7.c data integrity training documentation; X
V1M2 5.2.7.d in-depth data monitoring and data integrity procedure documentation; and X
V1M2 5.2.7.e
specific examples of breaches of ethical behavior such as improper data manipulations, adjustments of instrument time clocks, and inappropriate changes in concentrations of standards.

X
V1M2 5.2.7
The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees.

X
V1M2 5.3 Accommodation and Environmental Conditions (ISO/IEC 17025:2005, Clause 5.3) N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.3.1
Laboratory facilities for testing and/or calibration, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests and/or calibrations.

X
V1M2 5.3.1
The laboratory shall ensure that the environmental conditions do not invalidate the results or adversely affect the required quality of any measurement.

X
V1M2 5.3.1
Particular care shall be taken when sampling and tests and/or calibrations are undertaken at sites other than a permanent laboratory facility.

X
V1M2 5.3.1
The technical requirements for accommodation and environmental conditions that can affect the results of tests and calibrations shall be documented.

X
V1M2 5.3.2
The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results.

X
V1M2 5.3.2
Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned.

X
V1M2 5.3.2 Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations. X V1M2 5.3.3 There shall be effective separation between neighbouring areas in which there are incompatible activities. X
V1M2 5.3.3 Measures shall be taken to prevent cross-contamination. X V1M2 5.3.4 Access to and use of areas affecting the quality of the tests and/or calibrations shall be controlled. X
V1M2 5.3.4 The laboratory shall determine the extent of control based on its particular circumstances. X
V1M2 5.3.5 Measures shall be taken to ensure good housekeeping in the laboratory. X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.3.5 Special procedures shall be prepared where necessary. X V1M2 5.4 Environmental Test Methods and Method Validation N/A V1M2 5.4
All references to Calibration Laboratories and Calibration Methods in ISO/IEC 17025:2005 in these Clauses are not applicable to environmental testing.

N/A
V1M2 5.4.1 General (ISO/IEC 17025:2005, Clause 5.4.1) N/A V1M2 5.4.1 The laboratory shall use appropriate methods and procedures for all tests and/or calibrations within its scope. X
V1M2 5.4.1
These include sampling, handling, transport, storage and preparation of items to be tested and/or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test and/or calibration data.

X
V1M2 5.4.1
The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could jeopardize the results of tests and/or calibrations.

X
V1M2 5.4.1
All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel (see 4.3).

X
V1M2 5.4.1
Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.

X
V1M2 5.4.1 N
NOTE: International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the operating staff in a laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional details.

N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.4.2 Selection of Methods (ISO/IEC 17025:2005, Clause 5.4.2) N/A V1M2 5.4.2
The laboratory shall use test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes.

X
V1M2 5.4.2 Methods published in international, regional or national standards shall preferably be used. X
V1M2 5.4.2 The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. X V1M2 5.4.2 When necessary, the standard shall be supplemented with additional details to ensure consistent application. X
V1M2 5.4.2
When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment.

X
V1M2 5.4.2
Laboratory-developed methods or methods adopted by the
laboratory may also be used if they are appropriate for the intended use and if they are validated.

X
V1M2 5.4.2 The customer shall be informed as to the method chosen. X V1M2 5.4.2 The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations. X V1M2 5.4.2 If the standard method changes, the confirmation shall be repeated. X
V1M2 5.4.2
The laboratory shall inform the customer when the method proposed by the customer is considered to be inappropriate or out of date.

X
V1M2 5.4.3 Laboratory-Developed Methods (ISO/IEC 17025:2005, Clause

5.4.3) N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.4.3
The introduction of test and calibration methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate
resources.

X
V1M2 5.4.3 Plans shall be updated as development proceeds and effective communication amongst all personnel involved shall be ensured. X V1M2 5.4.4 Non-Standard Methods (ISO/IEC 17025:2005 Clause 5.4.4) N/A V1M2 5.4.4
When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer's requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use.

X
V1M2 5.4.4 N
Note: For new test and/or calibration methods, procedures should be developed prior to the tests and/or calibrations being performed and should contain at least the following information:

X
V1M2 5.4.4 N Though this is a Note in ISO language, Section 5.4.4.1 requires that this information be assessed. X
V1M2 5.4.4 a) appropriate identification; X
V1M2 5.4.4 b) scope; X
V1M2 5.4.4 c) description of the type of item to be tested or calibrated; X V1M2 5.4.4 d) parameters or quantities and ranges to be determined; X V1M2 5.4.4 e) apparatus and equipment, including technical performance requirements; X
V1M2 5.4.4 f) reference standards and reference materials required; X V1M2 5.4.4 g) environmental conditions required and any stabilization period needed; X
V1M2 5.4.4 h) description of the procedure, including X V1M2 5.4.4 h) affixing of identification marks, handling, transporting, storing and preparation of items, X
V1M2 5.4.4 h) checks to be made before the work is started, X Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.4.4 h)
checks that the equipment is working properly and, where required, calibration and adjustment of the equipment before each use,
X
V1M2 5.4.4 h) the method of recording the observations and results, X V1M2 5.4.4 h) any safety measures to be observed; X
V1M2 5.4.4 i) criteria and/or requirements for approval/rejection; X V1M2 5.4.4 j) data to be recorded and method of analysis and presentation; X V1M2 5.4.4 k) the uncertainty or the procedure for estimating uncertainty. X V1M2 5.4.4.1 The note in 5.4.4 above, which includes a – k, shall be considered during the development of the method. X
V1M2 5.4.4.2
The laboratory shall ensure that once the method has been developed, a Standard Operating Procedure as outlined in 4.2.8.5 f shall be written.

X
V1M2 5.4.5 Validation of Methods (ISO/IEC 17025:2005, Clause 5.4.5). N/A V1M2 5.4.5.1
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

N/A
V1M2 5.4.5.2
The laboratory shall validate non-standard methods, laboratorydesigned/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.

The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use.

X
V1M2 5.4.5.2 N1 NOTE 1: Validation may include procedures for sampling, handling and transportation. N/A
V1M2 5.4.5.2 N2
NOTE 2: The techniques used for the determination of the performance of a method should be one of, or a combination of, the following:

N/A
V1M2 5.4.5.2 N2a calibration using reference standards or reference materials; N/A Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.4.5.2 N2b comparison of results achieved with other methods; N/A V1M2 5.4.5.2 N2c interlaboratory comparisons; N/A
V1M2 5.4.5.2 N2d systematic assessment of the factors influencing the result; N/A V1M2 5.4.5.2 N2e
assessment of the uncertainty of the results based on scientific understanding of the theoretical principles of the method and practical experience.

N/A
V1M2 5.4.5.2 N3
NOTE 3: When some changes are made in the validated nonstandard methods, the influence of such changes should be documented and, if appropriate, a new validation should be carried out.

N/A
V1M2 5.4.5.3
The range and accuracy of the values obtainable from validated methods (e.g. the uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences and/or crosssensitivity against interference from the matrix of the sample/test object), as assessed for the intended use, shall be relevant to the customers' needs.

X
V1M2 5.4.5.3 N1
NOTE 1: Validation includes specification of the requirements, determination of the characteristics of the methods, a check that the requirements can be fulfilled by using the method, and a statement on the validity.

N/A
V1M2 5.4.5.3 N2
NOTE 2: As method-development proceeds, regular review should be carried out to verify that the needs of the customer are still being fulfilled. Any change in requirements requiring modifications to the development plan should be approved and authorized.

N/A
V1M2 5.4.5.3 N3
NOTE 3:Validation is always a balance between costs, risks and technical possibilities. There are many cases in which the range and uncertainty of the values (e.g. accuracy, detection limit, selectivity, linearity, repeatability, reproducibility, robustness and cross-sensitivity) can only be given in a simplified way due to lack of information.

N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.4.5.4
All methods used by the laboratory, whether non standard or standard (reference) methods shall be validated before use to ensure that the laboratory has the capability of using the method for its intended use. See section 1.5. of each of the technical modules (Volume 1 Modules 3 through 7) for specific validation requirements. Non-standard methods must comply with 5.4.5.1 –

5.4.5.3 above in addition to specific requirements in Section 1.5 of the technical modules.

X
V1M2 5.4.6 Estimation of Analytical Uncertainty N/A
V1M2 5.4.6
Clause 5.4.6 of the ISO/IEC/IEC 17025:2005 concerning
calibration testing does not apply. The following requirement replaces the ISO/IEC Clause . Environmental testing laboratories shall have a procedure(s) for estimating analytical uncertainty.

Quality control measurement data may be used to determine analytical uncertainty.

X
V1M2 5.4.6.1
A calibration laboratory, or a testing laboratory performing its own calibrations, shall have and shall apply a procedure to estimate the uncertainty of measurement for all calibrations and types of calibrations.

X
V1M2 5.4.6.2
Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement. In certain cases the nature of the test method may preclude rigorous, metrologically and statistically valid, calculation of uncertainty of measurement. In these cases the laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation, and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. Reasonable estimation shall be based on knowledge of the performance of the method and on the measurement scope and shall make use of, for example, previous experience and validation data.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.4.6.2 N1 NOTE 1: The degree of rigor needed in an estimation of uncertainty of measurement depends on factors such as: N/A V1M2 5.4.6.2 N1 the requirements of the test method; N/A V1M2 5.4.6.2 N1 the requirements of the customer; N/A
V1M2 5.4.6.2 N1 the existence of narrow limits on which decisions on conformity to a specification are based. N/A
V1M2 5.4.6.2 N2
NOTE 2: In those cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied this clause by following the test method and reporting instructions (see 5.10).

N/A
V1M2 5.4.6.3
When estimating the uncertainty of measurement, all uncertainty components which are of importance in the given situation shall be taken into account using appropriate methods of analysis.

X
V1M2 5.4.6.3 N1
NOTE 1: Sources contributing to the uncertainty include, but are not necessarily limited to, the reference standards and reference materials used, methods and equipment used, environmental conditions, properties and condition of the item being tested or calibrated, and the operator.

N/A
V1M2 5.4.6.3 N2
NOTE 2: The predicted long-term behaviour of the tested and/or calibrated item is not normally taken into account when estimating the measurement uncertainty.

N/A
V1M2 5.4.6.3 N3 NOTE 3: For further information, see ISO 5725 and the Guide to the Expression of Uncertainty in Measurement (see Bibliography). N/A V1M2 5.4.7 Control of Data (ISO/IEC 17025:2005, Clause 5.4.7) N/A V1M2 5.4.7.1 Calculations and data transfers shall be subject to appropriate checks in a systematic manner. X
V1M2 5.4.7.2
When computers or automated equipment are used for the
acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that:

N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.4.7.2.a computer software developed by the user is documented in sufficient detail X
V1M2 5.4.7.2.a computer software developed by the user is suitably validated as being adequate for use; X
V1M2 5.4.7.2.b procedures are established and implemented for protecting the data; X
V1M2 5.4.7.2.b
such procedures shall include, but not be limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing;
X
V1M2 5.4.7.2.c computers and automated equipment are maintained to ensure proper functioning X
V1M2 5.4.7.2.c
computers and automated equipment are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data.

X
V1M2 5.4.7.2 N
NOTE: Commercial off-the-shelf software (e.g. word processing, database and statistical programmes) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/modifications should be validated as in 5.4.7.2 a).

N/A
V1M2 5.5 Calibration Requirements (ISO/IEC 17025:2005, Clause 5.5) N/A V1M2 5.5 ISO/IEC Clauses 5.5.1 to 5.5.12 apply with respect to equipment in environmental testing laboratories N/A
V1M2 5.5.1
In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the requirements of this International Standard are met.

X
V1M2 5.5.2
Equipment and its software used for testing, calibration and sampling shall be capable of achieving the accuracy required and shall comply with specifications relevant to the tests and/or calibrations concerned.

X
V1M2 5.5.2
Calibration programmes shall be established for key quantities or values of the instruments where these properties have a significant effect on the results.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.5.2
Before being placed into service, equipment (including that used for sampling) shall be calibrated or checked to establish that it meets the laboratory's specification requirements and complies with the relevant standard specifications.

X
V1M2 5.5.2 It (equipment) shall be checked and/or calibrated before use (see

5.6). X
V1M2 5.5.3 Equipment shall be operated by authorized personnel. X V1M2 5.5.3
Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) shall be readily available for use by the appropriate laboratory personnel.

X
V1M2 5.5.4
Each item of equipment and its software used for testing and calibration and significant to the result shall, when practicable, be uniquely identified.

X
V1M2 5.5.5 Records shall be maintained of each item of equipment and its software significant to the tests and/or calibrations performed. X V1M2 5.5.5 The records shall include at least the following: X V1M2 5.5.5.a the identity of the item of equipment X
V1M2 5.5.5.a the identity of the software; X
V1M2 5.5.5.b the manufacturer's name X
V1M2 5.5.5.b type identification X
V1M2 5.5.5.b and serial number or other unique identification; X V1M2 5.5.5.c checks that equipment complies with the specification (see 5.5.2); X V1M2 5.5.5.d the current location, where appropriate; X V1M2 5.5.5.e the manufacturer's instructions, if available, or reference to their location; X
V1M2 5.5.5.f dates, results and copies of reports and certificates of all calibrations X
V1M2 5.5.5.f dates, results and copies of reports and certificates of all adjustments X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.5.5.f dates, results and copies of reports and certificates of all acceptance criteria X
V1M2 5.5.5.f the due date of next calibration; X
V1M2 5.5.5.g the maintenance plan, where appropriate X
V1M2 5.5.5.g and maintenance carried out to date; X
V1M2 5.5.5.h any damage, malfunction, modification or repair to the equipment. X V1M2 5.5.6
The laboratory shall have procedures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration.

X
V1M2 5.5.6 N
NOTE: Additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for tests, calibrations or sampling.

N/A
V1M2 5.5.7
Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service X
V1M2 5.5.7
It (equipment) shall be isolated to prevent its use or clearly labelled or marked as being out of service until it has been repaired and shown by calibration or test to perform correctly.

X
V1M2 5.5.7
The laboratory shall examine the effect of the defect or departure from specified limits on previous tests and/or calibrations and shall institute the "Control of nonconforming work" procedure (see 4.9).

X
V1M2 5.5.8
Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the status of calibration X
V1M2 5.5.8
Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the date when last calibrated X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.5.8
Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the date or expiration criteria when recalibration is due.

X
V1M2 5.5.9
When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory shall ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service.

X
V1M2 5.5.10
When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks shall be carried out according to a defined procedure.

X
V1M2 5.5.11
Where calibrations give rise to a set of correction factors, the laboratory shall have procedures to ensure that copies (e.g. in computer software) are correctly updated.

X
V1M2 5.5.12
Test and calibration equipment, including both hardware and software, shall be safeguarded from adjustments which would invalidate the test and/or calibration results.

X
V1M2 5.5.12 N NOTE: ISO/IEC Clauses 5.5.1 to 5.5.12 apply with respect to equipment in environmental testing laboratories. N/A
V1M2 5.5.13 Additional Requirements and Clarifications N/A V1M2 5.5.13
Calibration requirements for analytical support equipment are included in this Section while requirements for instrument (testing) calibration are included in technical modules (i.e., Asbestos, Chemistry, Microbiology, Radiochemistry and Toxicology).

N/A
V1M2 5.5.13.1 Support Equipment N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.5.13.1
This Standard applies to all devices that may not be the actual test instrument, but are necessary to support laboratory operations.

These include, but are not limited to: balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices (including thermometers and thermistors), thermal/pressure sample preparation devices and mechanical volumetric dispensing devices (such as Eppendorf® or automatic dilutor/dispensing devices).

N/A
V1M2 5.5.13.1 a)
The results of any calibration or verification shall be within the specifications required of the application for which this equipment is used. The laboratory shall define the specifications for acceptability if none exist in method or regulation. If any equipment fails to meet the specifications for acceptability:

X
V1M2 5.5.13.1 a) i) the equipment shall be removed from service until repaired; or X V1M2 5.5.13.1 a) ii) the laboratory shall maintain records of established correction factors to correct all measurements. X
V1M2 5.5.13.1 b)
The laboratory shall maintain all support equipment in proper working order. The records of all repair and maintenance activities, including service calls, shall be kept.

X
V1M2 5.5.13.1 c)
On each day the equipment is used, balances, ovens,
refrigerators, freezers, incubators and water baths shall be checked and documented. The acceptability for use or continued use shall be according to the needs of the analysis or application for which the equipment is being used.

X Refrigerator temps missing on
weekends
V1M2 5.5.13.1 d)
Temperature measuring devices shall be calibrated or verified at least annually. Calibration or verification shall be performed using a recognized National Metrology Institute traceable reference, such as NIST, when available.

X
V1M2 5.5.13.1 d) i)
If the temperature measuring device is used over a range of 10°C or less, then a single point verification within the range of use is acceptable;
X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.5.13.1 d) ii)
If the temperature measuring device is used over a range of greater than 10°C, then the verification must bracket the range of use.

X
V1M2 5.5.13.1 e)
If quantitative results are dependent on their accuracy, such as in standard preparation or dispensing or dilution into a specified volume, the laboratory shall verify volumetric measuring devices as follows:

X
V1M2 5.5.13.1 e) i)
Glass microliter syringes and Class A glassware are exempt from any verification requirements beyond what is stated in Section

4.6.2;
X
V1M2 5.5.13.1 e) ii) Disposable or single-use volumetric equipment shall be verified once per lot, prior to or in conjunction with its first use; X V1M2 5.5.13.1 e) iii)
Mechanical devices shall be verified prior to first use and on a quarterly basis. Mechanical devices used at more than one volume shall be verified at volumes bracketing the range of use, and at the mid-point of the volumes used by the device;
X
V1M2 5.5.13.1 e) iv) All other volumetric support equipment shall be checked for accuracy prior to or in conjunction with its first use. X V1M2 5.5.13.1 f)
All other support equipment shall be calibrated or verified at least annually, using a recognized National Metrology Institute, such as NIST, traceable reference when available, bracketing the range of use.

X
V1M2 5.5.13.1 g) Raw data records shall be retained to document equipment performance. X
V1M2 5.6 Measurement Traceability N/A
V1M2 5.6.1 General (ISO/IEC 17025:2005, Clause 5.6.1) N/A Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.6.1
All equipment used for tests and/or calibrations, including equipment for subsidiary measurements (e.g. for
environmental conditions) having a significant effect on the accuracy or validity of the result of the test,
calibration or sampling shall be calibrated before being put into service. The laboratory shall have an
established programme and procedure for the calibration of its equipment.

N/A
V1M2 5.6.1 N
NOTE Such a programme should include a system for selecting, using, calibrating, checking, controlling and
maintaining measurement standards, reference materials used as measurement standards, and measuring
and test equipment used to perform tests and calibrations.

N/A
V1M2 5.6.2 Specific Requirements (ISO/IEC 17025:2005, Clause 5.6.2) N/A V1M2 5.6.2.1 Calibration N/A
V1M2 5.6.2.1.1
For calibration laboratories, the programme for calibration of equipment shall be designed and operated so as to ensure that calibrations and measurements made by the laboratory are traceable to the International System of Units (SI) (Système international d'unités).

N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.6.2.1.1
A calibration laboratory establishes traceability of its own measurement standards and measuring instruments to the SI by means of an unbroken chain of calibrations or comparisons linking them to relevant primary standards of the SI units of
measurement. The link to SI units may be achieved by reference to national measurement standards. National measurement standards may be primary standards, which are primary
realizations of the SI units or agreed representations of SI units based on fundamental physical constants, or they may be secondary standards which are standards calibrated by another national metrology institute. When using external calibration services, traceability of measurement shall be assured by the use of calibration services from laboratories that can demonstrate competence, measurement capability and traceability. The calibration certificates issued by these laboratories shall contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification (see also 5.10.4.2).

N/A
V1M2 5.6.2.1.1 N1
NOTE 1: Calibration laboratories fulfilling the requirements of this International Standard are considered to be competent. A calibration certificate bearing an accreditation body logo from a calibration laboratory accredited to this International Standard, for the calibration concerned, is sufficient evidence of traceability of the calibration data reported.

N/A
V1M2 5.6.2.1.1 N2
NOTE 2: Traceability to SI units of measurement may be achieved by reference to an appropriate primary standard (see VIM:1993,

6.4) or by reference to a natural constant, the value of which in terms of the relevant SI unit is known and recommended by the General Conference of Weights and Measures (CGPM) and the International Committee for Weights and Measures (CIPM).

N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.6.2.1.1 N3
NOTE 3: Calibration laboratories that maintain their own primary standard or representation of SI units based on fundamental physical constants can claim traceability to the SI system only after these standards have been compared, directly or indirectly, with other similar standards of a national metrology institute.

N/A
V1M2 5.6.2.1.1 N4
NOTE 4: The term “identified metrological specification” means that it must be clear from the calibration certificate which specification the measurements have been compared with, by including the specification or by giving an unambiguous reference to the specification.

N/A
V1M2 5.6.2.1.1 N5
NOTE 5: When the terms “international standard” or “national standard” are used in connection with traceability, it is assumed that these standards fulfil the properties of primary standards for the realization of SI units.

N/A
V1M2 5.6.2.1.1 N6
NOTE 6: Traceability to national measurement standards does not necessarily require the use of the national metrology institute of the country in which the laboratory is located.

N/A
V1M2 5.6.2.1.1 N7
NOTE: 7: If a calibration laboratory wishes or needs to obtain traceability from a national metrology institute other than in its own country, this laboratory should select a national metrology institute that actively participates in the activities of BIPM either directly or through regional groups.

N/A
V1M2 5.6.2.1.1 N8
NOTE 8: The unbroken chain of calibrations or comparisons may be achieved in several steps carried out by different laboratories that can demonstrate traceability.

N/A
V1M2 5.6.2.1.2
There are certain calibrations that currently cannot be strictly made in SI units. In these cases calibration shall provide confidence in measurements by establishing traceability to appropriate measurement standards such as:

N/A
V1M2 5.6.2.1.2
the use of certified reference materials provided by a competent supplier to give a reliable physical or chemical characterization of a material
N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.6.2.1.2 the use of specified methods and/or consensus standards that are clearly described and agreed by all parties concerned N/A V1M2 5.6.2.1.2 Participation in a suitable programme of interlaboratory comparisons is required where possible N/A
V1M2 5.6.2.2 Testing N/A
V1M2 5.6.2.2.1
For testing laboratories, the requirements given in 5.6.2.1 apply for measuring and test equipment with measuring functions used, unless it has been established that the associated contribution from the calibration contributes little to the total uncertainty of the test result. When this situation arises, the laboratory shall ensure that the equipment used can provide the uncertainty of
measurement needed.

N/A
V1M2 5.6.2.2.1 N
NOTE: The extent to which the requirements in 5.6.2.1 should be followed depends on the relative contribution of the calibration uncertainty to the total uncertainty. If calibration is the dominant factor, the requirements should be strictly followed
N/A
V1M2 5.6.2.2.2
Where traceability of measurements to SI units is not possible and/or not relevant, the same requirements for traceability to, for example, certified reference materials, agreed methods and/or consensus standards, are required as for calibration laboratories (see 5.6.2.1.2).

N/A
V1M2 5.6.3 Reference Standards and Reference Materials (ISO/IEC 17025:2005, Clause 5.6.3) N/A
V1M2 5.6.3.1 Reference Standards N/A
V1M2 5.6.3.1 The laboratory shall have a programme and procedure for the calibration of its reference standards. X
V1M2 5.6.3.1 Reference standards shall be calibrated by a body that can provide traceability as described in 5.6.2.1. X
V1M2 5.6.3.1
Such reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.6.3.1 Reference standards shall be calibrated before and after any adjustment. X
V1M2 5.6.3.2 Reference Materials N/A
V1M2 5.6.3.2 Reference materials shall, where possible, be traceable to SI units of measurement, or to certified reference materials X
V1M2 5.6.3.2 Internal reference materials shall be checked as far as is technically and economically practicable. X
V1M2 5.6.3.3 Intermediate Checks N/A
V1M2 5.6.3.3
Checks needed to maintain confidence in the calibration status of reference, primary, transfer or working standards and reference materials shall be carried out according to defined procedures and schedules.

X
V1M2 5.6.3.4 Transport and Storage N/A
V1M2 5.6.3.4
The laboratory shall have procedures for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity.

X
V1M2 5.6.3.4 N
NOTE: Additional procedures may be necessary when reference standards and reference materials are used outside the
permanent laboratory for tests, calibrations or sampling.

N/A
V1M2 5.6.4 Additional Requirements and Clarifications N/A V1M2 5.6.4.1 Reference Standards and Reference Materials N/A V1M2 5.6.4.1
The laboratory shall provide satisfactory evidence of correlation of results, for example, by participation in a suitable program of interlaboratory comparisons, proficiency testing, or independent analysis.

X
V1M2 5.6.4.1.a Reference Standards N/A
V1M2 5.6.4.1.a Where commercially available, this traceability shall be to a national standard of measurement. X
V1M2 5.6.4.1.b Reference Materials N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.6.4.1.b
Where possible, traceability shall be to national or international standards of measurement or to national or international standard reference materials.

X
V1M2 5.6.4.1.b Internal reference materials shall be checked as far as is technically and economically practicable. X
V1M2 5.6.4.2 Documentation and Labeling of Standards, Reagents, and Reference Materials N/A
V1M2 5.6.4.2
Documented procedures shall exist for the purchase, receipt and storage of consumable materials used for the technical operations of the laboratory.

X
V1M2 5.6.4.2.a The laboratory shall retain records for all standards, reagents, reference materials, and media, including the manufacturer/vendor X V1M2 5.6.4.2.a
The laboratory shall retain records for all standards, reagents, reference materials, and media, including the manufacturer’s Certificate of Analysis or purity (if available)
X
V1M2 5.6.4.2.a The laboratory shall retain records for all standards, reagents, reference materials, and media, including the date of receipt X V1M2 5.6.4.2.a
The laboratory shall retain records for all standards, reagents, reference materials, and media, including recommended storage conditions.

X
V1M2 5.6.4.2.b
For original containers, if an expiration date is provided by the manufacturer or vendor it shall be recorded on the container. If an expiration date is not provided by the manufacturer or vendor it is not required.

X
V1M2 5.6.4.2.c
Records shall be maintained on standard, reference material, and reagent preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials
X
V1M2 5.6.4.2.d All containers of prepared standards, reference materials, and reagents shall bear a unique identifier X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.6.4.2.d All containers of prepared standards, reference materials, and reagents shall bear an expiration date. X
V1M2 5.6.4.2.e Procedures shall be in place to ensure prepared reagents meet the requirements of the method. X
V1M2 5.6.4.2.f
Standards, reference materials, and reagents shall not be used after their expiration dates unless their reliability is verified by the laboratory.

X
V1M2 5.7 Collection of Samples (ISO/IEC 17025:2005, Clause 5.7) N/A V1M2 5.7.1
The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing or calibration.

X
V1M2 5.7.1 The sampling plan as well as the sampling procedure shall be available at the location where sampling is undertaken. X V1M2 5.7.1 Sampling plans shall, whenever reasonable, be based on appropriate statistical methods. X
V1M2 5.7.1 The sampling process shall address the factors to be controlled to ensure the validity of the test and calibration results. X V1M2 5.7.1 N1
NOTE 1: Sampling is a defined procedure whereby a part of a substance, material or product is taken to provide for testing or calibration of a representative sample of the whole. Sampling may also be required by the appropriate specification for which the substance, material or product is to be tested or calibrated. In certain cases (e.g. forensic analysis), the sample may not be representative but is determined by availability.

N/A
V1M2 5.7.1 N2
NOTE 2: Sampling procedures should describe the selection, sampling plan, withdrawal and preparation of a sample or samples from a substance, material or product to yield the required information.

N/A
V1M2 5.7.2
Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be recorded in detail with the appropriate sampling data
X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.7.2
Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be included in all documents containing test and/or calibration results X
V1M2 5.7.2
Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be
communicated to the appropriate personnel.

X
V1M2 5.7.3
The laboratory shall have procedures for recording relevant data and operations relating to sampling that forms part of the testing or calibration that is undertaken.

X
V1M2 5.7.3
These records shall include the sampling procedure used, the identification of the sampler, environmental conditions (if relevant) and diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon.

X
V1M2 5.7.4 Additional Requirements N/A
V1M2 5.7.4.a Documentation shall include the date of sampling. X V1M2 5.7.4.a Documentation shall include the time of sampling. X V1M2 5.7.4.b Any deviations from sampling procedures shall be documented. X V1M2 5.8 Handling Samples and Test Items (ISO/IEC 17025:2005, Clause

5.8) N/A
V1M2 5.8.1
The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer.

X
V1M2 5.8.2 The laboratory shall have a system for identifying test and/or calibration items. X
V1M2 5.8.2 The identification shall be retained throughout the life of the item in the laboratory. X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.8.2
The system shall be designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents.

X
V1M2 5.8.2
The system shall, if appropriate, accommodate a sub-division of groups of items and the transfer of items within and from the laboratory.

X
V1M2 5.8.3
Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the test or calibration method, shall be recorded
X
V1M2 5.8.3
When there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, the laboratory shall consult the customer for further instructions before proceeding and shall record the discussion.

X
V1M2 5.8.4
The laboratory shall have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation.

X
V1M2 5.8.4 Handling instructions provided with the item shall be followed. X V1M2 5.8.4
When items have to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.

X
V1M2 5.8.4
Where a test or calibration item or a portion of an item is to be held secure, the laboratory shall have arrangements for storage and security that protect the condition and integrity of the secured items or portions concerned.

X
V1M2 5.8.4 N1
NOTE 1: Where test items are to be returned into service after testing, special care is required to ensure that they are not damaged or injured during the handling, testing or storing/waiting processes.

N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.8.4 N2
NOTE 2: A sampling procedure and information on storage and transport of samples, including information on sampling factors influencing the test or calibration result, should be provided to those responsible for taking and transporting the samples.

N/A
V1M2 5.8.4 N3
NOTE 3: Reasons for keeping a test or calibration item secure can be for reasons of record, safety or value, or to enable complementary tests and/or calibrations to be performed later.

N/A
V1M2 5.8.5 Additional Requirements - Documentation N/A
V1M2 5.8.5 The following are essential to ensure the validity of the laboratory’s data. N/A
V1M2 5.8.V1M2 5.a
The laboratory shall have a documented system for uniquely identifying the sample containers that hold samples to be tested, to ensure that there can be no confusion regarding the identity of such samples at any time.

X
V1M2 5.8.V1M2 5.a
This system shall include identification for all samples, subsamples, preservations, sample containers, tests, and subsequent extracts and/or digestates.

X
V1M2 5.8.V1M2 5.b This laboratory code shall maintain an unequivocal link with the unique field ID code assigned to each sample. X
V1M2 5.8.V1M2 5.c The laboratory ID code shall be placed as a durable mark on the sample container. X
V1M2 5.8.V1M2 5.d The laboratory ID code shall be entered into the laboratory records X V1M2 5.8.V1M2 5.d The laboratory ID code shall be the link that associates the sample with related laboratory activities such as sample preparation. X V1M2 5.8.V1M2 5.e
In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the laboratory ID code may be the same as the field ID code.

X
V1M2 5.8.6 Additional Requirements - Sample Acceptance Policy N/A Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.8.6 The laboratory shall have a written sample acceptance policy that includes the following: X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include sample identification X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include the location of collection X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include the date of collection X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include the time of collection X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include collector's name X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include preservation type X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include sample type X
V1M2 5.8.6.a proper, full, and complete documentation, which shall include any special remarks concerning the sample; X
V1M2 5.8.6.b proper sample labeling to include unique identification X V1M2 5.8.6.b
proper sample labeling to include a labeling system for the samples with requirements concerning the durability of the labels (water resistant) and the use of indelible ink;
X
V1M2 5.8.6.c use of appropriate sample containers; X
V1M2 5.8.6.d adherence to specified holding times; X
V1M2 5.8.6.e sufficient sample volume to perform the necessary tests; X V1M2 5.8.6.f procedures to be used when samples show signs of damage, contamination or inadequate preservation; and X
V1M2 5.8.6.g qualification of any data that do not meet the above requirements. X V1M2 5.8.7 Additional Requirements - Sample Receipt Protocols N/A V1M2 5.8.7.1 The laboratory shall implement procedures for verifying and documenting preservation. X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.8.7.2 If the sample does not meet the sample receipt acceptance criteria listed in this Standard, the laboratory shall either:

X
V1M2 5.8.7.2.a retain correspondence and/or records of conversations concerning the final disposition of rejected samples; or
X
V1M2 5.8.7.2.b fully document any decision to proceed with the analysis of samples not meeting acceptance criteria.

X
V1M2 5.8.7.2.i The condition of these samples shall be noted on the chain of custody or transmittal form and laboratory receipt documents.

X
V1M2 5.8.7.2.ii The analysis data shall be appropriately qualified on the final report.

X
V1M2 5.8.7.3
The laboratory shall utilize a permanent chronological record such as a logbook or electronic database to document receipt of all sample containers.

X
V1M2 5.8.7.3.a This sample receipt log shall record the following: N/A V1M2 5.8.7.3.a.i client/project name,X
V1M2 5.8.7.3.a.ii date and time of laboratory receipt,X V1M2 5.8.7.3.a.iii unique laboratory ID code (see Section 5.8.5 a), andX V1M2 5.8.7.3.a.iv signature or initials of the person making the entries.X V1M2 5.8.7.3.b
During the login process, the following information shall be unequivocally linked to the log record or included as a part of the log.

X
V1M2 5.8.7.3.b
If such information is recorded/documented elsewhere, the records shall be part of the laboratory's permanent records, easily retrievable upon request and readily available to individuals who will process the sample.

X
V1M2 5.8.7.3.b The placement of the laboratory ID number on the sample container is not considered a permanent record.

X
V1M2 5.8.7.3.b.i The field ID code, which identifies each sample, shall be linked to the laboratory ID code in the sample receipt log.

X
V1M2 5.8.7.3.b.ii The date and time of sample collection shall be linked to the sample and to the date and time of receipt in the laboratory.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.8.7.3.b.iii The requested analyses (including applicable approved method numbers) shall be linked to the laboratory ID code. X
V1M2 5.8.7.3.b.iv Any comments resulting from inspection for sample rejection shall be linked to the laboratory ID code. X
V1M2 5.8.7.4
All documentation, such as memos, chain of custody, or transmittal forms that are transmitted to the laboratory by the sample transmitter, shall be retained.

X
V1M2 5.8.7.5 A complete chain of custody record form, if utilized, shall be maintained. X
V1M2 5.8.8 Additional Requirements - Legal Chain of Custody Protocols N/A V1M2 5.8.8 Legal chain of custody procedures are used for evidentiary or legal purposes.

N/A
V1M2 5.8.8
If a client specifies that a sample is to be used for evidentiary purposes, then a laboratory shall have a written SOP for how that laboratory will carry out legal chain of custody.

X
V1M2 5.8.9 Additional Requirements - Sample Storage and Disposal N/A V1M2 5.8.9.a Samples shall be stored according to the conditions specified by preservation protocols. X
V1M2 5.8.9.a.i
Samples that require thermal preservation shall be stored under refrigeration that is +/-2°C of the specified preservation temperature unless regulatory or method specific criteria exist.

X
V1M2 5.8.9.a.i
For samples with a specified storage temperature of 4°C, storage at a temperature above the freezing point of water to 6°C shall be acceptable.

X
V1M2 5.8.9.a.ii
Samples shall be stored away from all standards, reagents, and food. Samples shall be stored in such a manner to prevent cross contamination.

X
V1M2 5.8.9.b
Sample fractions, extracts, leachates and other sample
preparation products shall be stored according to Section 5.8.9 a) above or according to specifications in the method.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.8.9.c
The laboratory shall have SOPs for the disposal of samples, digestates, leachates and extracts or other sample preparation products.

X
V1M2 5.9 Quality Assurance for Environmental Testing (ISO/IEC 17025:2005, Clause 5.9) N/A
V1M2 5.9.1 The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. X
V1M2 5.9.1
The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results.

X
V1M2 5.9.1 This monitoring shall be planned and reviewed and may include, but not be limited to, the following: X
V1M2 5.9.1.a regular use of certified reference materials and/or internal quality control using secondary reference materials; X
V1M2 5.9.1.b participation in interlaboratory comparison or proficiency-testing programmes;
X
V1M2 5.9.1.c replicate tests or calibrations using the same or different methods; X V1M2 5.9.1.d retesting or recalibration of retained items; X V1M2 5.9.1.e correlation of results for different characteristics of an item. X V1M2 5.9.1.e N NOTE: The selected methods should be appropriate for the type and volume of the work undertaken. N/A
V1M2 5.9.2
Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported.

X
V1M2 5.9.3 Essential Quality Control Procedures N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.9.3
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed:

N/A
V1M2 5.9.3.a All laboratories shall have detailed written protocols in place to monitor the following quality controls: X
i. through viii are specified for the technologies identified in the technical modules. These should be used if the laboratory is using a technology other than those specified in Modules 3 through 7
N/A
V1M2 5.9.3.a.i
positive and negative controls (see technical modules), chemical or microbiological as applicable to the test type, to monitor tests such as blanks, matrix spikes, reference toxicants;
N/A
V1M2 5.9.3.a.ii tests to define the variability and/or repeatability of the laboratory results such as replicates; N/A
V1M2 5.9.3.a.iii
measures to assure the accuracy of the method including calibration and/or continuing calibrations, use of certified reference materials, proficiency test samples, or other measures; N/A
V1M2 5.9.3.a.iv measures to evaluate method capability, such as limit of detection and limit of quantitation or range of applicability such as linearity; N/A V1M2 5.9.3.a.v
selection of appropriate formulae to reduce raw data to final results such as regression analysis, comparison to internal/external standard calculations, and statistical analyses;
N/A
V1M2 5.9.3.a.vi selection and use of reagents and standards of appropriate quality; N/A
V1M2 5.9.3.a.vii measures to assure the selectivity of the test for its intended purpose; and N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.9.3.a.viii
measures to assure constant and consistent test conditions (both instrumental and environmental) where required by the method such as temperature, humidity, light or specific instrument conditions.

N/A
V1M2 5.9.3.b
All quality control measures shall be assessed and evaluated on an on-going basis and quality control acceptance criteria shall be used.

X
V1M2 5.9.3.c
The laboratory shall have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exist.

X
V1M2 5.9.3.c The quality control protocols specified by the laboratory’s SOP shall be followed (see Section 4.2.8.5 in this Standard). X V1M2 5.9.3.c
The laboratory shall ensure that the essential standards outlined in Technical Modules or mandated methods or regulations (whichever are more stringent) are incorporated into their method manuals.

X
V1M2 5.9.3.c When it is not apparent which is more stringent, the QC in the mandated method or regulations is to be followed. X
V1M2 5.1 Reporting the Results N/A
V1M2 5.1 All references to Calibration Certificates in ISO/IEC 17025:2005 are not applicable to environmental testing. N/A
V1M2 5.10.1 General (ISO/IEC 17025:2005, Clause 5.10.1) N/A V1M2 5.10.1
The results of each test, calibration, or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods.

X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.10.1
The results shall be reported, usually in a test report or a calibration certificate (see Note 1), and shall include all the information requested by the customer and necessary for the interpretation of the test or calibration results and all information required by the method used. This information is normally that required by 5.10.2, and 5.10.3 or 5.10.4.

X
V1M2 5.10.1
In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified way.

X
V1M2 5.10.1
Any information listed in 5.10.2 to 5.10.4 which is not reported to the customer shall be readily available in the laboratory which carried out the tests and/or calibrations.

X
V1M2 5.10.1 N1 NOTE 1: Test reports and calibration certificates are sometimes called test certificates and calibration reports respectively. N/A V1M2 5.10.1 N2
NOTE 2: The test reports or calibration certificates may be issued as hard copy or by electronic data transfer provided that the requirements of this International Standard are met.

N/A
V1M2 5.10.2 Test Reports and Calibration Certificates (ISO/IEC 17025:2005, Clause 5.10.2) N/A
V1M2 5.10.2
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so:

N/A
V1M2 5.10.2.a a title (e.g. "Test Report" or "Calibration Certificate"); X V1M2 5.10.2.b
the name and address of the laboratory, and the location where the tests and/or calibrations were carried out, if different from the address of the laboratory;
X
V1M2 5.10.2.c
unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate;
X
V1M2 5.10.2.d the name and address of the customer; X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.10.2.e identification of the method used; X
V1M2 5.10.2.f a description of, the condition of, and unambiguous identification of the item(s) tested or calibrated; X
V1M2 5.10.2.g
the date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration;
X
V1M2 5.10.2.h
reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results;
X
V1M2 5.10.2.i the test or calibration results with, where appropriate, the units of measurement; X
V1M2 5.10.2.j
the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate;
X
V1M2 5.10.2.k where relevant, a statement to the effect that the results relate only to the items tested or calibrated. X
V1M2 5.10.2 N1 NOTE 1: Hard copies of test reports and calibration certificates should also include the page number and total number of pages. N/A V1M2 5.10.2 N2
NOTE 2: It is recommended that laboratories include a statement specifying that the test report or calibration certificate shall not be reproduced except in full, without written approval of the laboratory.

N/A
V1M2 5.10.3 Test Reports (ISO/IEC 17025:2005, Clause 5.10.3) N/A V1M2 5.10.3.1
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include the following:

N/A
V1M2 5.10.3.1.a
deviations from, additions to, or exclusions from the test method, and information on specific test conditions, such as environmental conditions;
X
V1M2 5.10.3.1.b where relevant, a statement of compliance/non-compliance with requirements and/or specifications; X
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.10.3.1.c
where applicable, a statement on the estimated uncertainty of measurement; information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a customer's instruction so requires, or when the uncertainty affects compliance to a specification limit;
X
V1M2 5.10.3.1.d where appropriate and needed, opinions and interpretations (see

5.10.5); X
V1M2 5.10.3.1.e additional information which may be required by specific methods, customers or groups of customers. X
V1M2 5.10.3.2
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results:

X
V1M2 5.10.3.2.a the date of sampling; X
V1M2 5.10.3.2.b
unambiguous identification of the substance, material or product sampled (including the name of the manufacturer, the model or type of designation and serial numbers as appropriate); X
V1M2 5.10.3.2.c the location of sampling, including any diagrams, sketches or photographs; X
V1M2 5.10.3.2.d a reference to the sampling plan and procedures used; X V1M2 5.10.3.2.e details of any environmental conditions during sampling that may affect the interpretation of the test results; X
V1M2 5.10.3.2.f
any standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions from the specification concerned.

X
V1M2 5.10.4 Calibration Certificates (ISO/IEC 17025:2005, Clause 5.10.4) X V1M2 5.10.4 Calibration Certificates (ISO/IEC 17025:2005, Clause 5.10.4) does not apply to environmental testing activities. N/A
V1M2 5.10.4.1
In addition to the requirements listed in 5.10.2, calibration certificates shall include the following, where necessary for the interpretation of calibration results:

N/A
V1M2 5.10.4.1 a) the conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results; N/A Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.10.4.1 b) the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses thereof; N/A V1M2 5.10.4.1 c) evidence that the measurements are traceable (see Note 2 in

5.6.2.1.1). N/A
V1M2 5.10.4.2
The calibration certificate shall relate only to quantities and the results of functional tests. If a statement of compliance with a specification is made, this shall identify which clauses of the specification are met or not met. When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, the laboratory shall record those results and maintain them for possible future reference. When statements of compliance are made, the uncertainty of measurement shall be taken into account.

N/A
V1M2 5.10.4.3
When an instrument for calibration has been adjusted or repaired, the calibration results before and after adjustment or repair, if available, shall be reported.

N/A
V1M2 5.10.4.4
A calibration certificate (or calibration label) shall not contain any recommendation on the calibration interval except where this has been agreed with the customer. This requirement may be
superseded by legal regulations.

N/A
V1M2 5.10.5 Opinions and interpretations N/A
V1M2 5.10.5
When opinions and interpretations are included, the laboratory shall document the basis upon which the opinions and
interpretations have been made. Opinions and interpretations shall be clearly marked as such in a test report.

V1M2 5.10.5 N1
NOTE 1: Opinions and interpretations should not be confused with inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65.

N/A
V1M2 5.10.5 N2 NOTE 2: Opinions and interpretations included in a test report may comprise, but not be limited to, the following: N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.10.5 N2 • an opinion on the statement of compliance/noncompliance of the results with requirements; N/A
V1M2 5.10.5 N2 • fulfilment of contractual requirements; N/A V1M2 5.10.5 N2 • recommendations on how to use the results; N/A V1M2 5.10.5 N2 • guidance to be used for improvements. N/A V1M2 5.10.5 N3
NOTE 3: In many cases it might be appropriate to communicate the opinions and interpretations by direct dialogue with the customer. Such dialogue should be written down.

N/A
V1M2 5.10.6 Testing and calibration results obtained from subcontractors N/A V1M2 5.10.6 When the test report contains results of tests performed by subcontractors, these results shall be clearly identified. X V1M2 5.10.6
The subcontractor shall report the results in writing or electronically. When a calibration has been subcontracted, the laboratory performing the work shall issue the calibration certificate to the contracting laboratory.

X
V1M2 5.10.7 Electronic transmission of results N/A
V1M2 5.10.7
In the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be met (see also 5.4.7).

X
V1M2 5.10.8 Format of reports and certificates N/A
V1M2 5.10.8
The format shall be designed to accommodate each type of test or calibration carried out and to minimize the possibility of misunderstanding or misuse.

X
V1M2 5.10.8 N1
NOTE 1: Attention should be given to the lay-out of the test report or calibration certificate, especially with regard to the presentation of the test or calibration data and ease of assimilation by the reader.

N/A
V1M2 5.10.8 N2 NOTE 2: The headings should be standardized as far as possible. N/A V1M2 5.10.9 Amendments to test reports and calibration certificates N/A Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.10.9
Material amendments to a test report or calibration certificate after issue shall be made only in the form of a further document, or data transfer, which includes the statement: “Supplement to Test Report [or Calibration Certificate], serial number... [or as otherwise identified]”, or an equivalent form of wording.

X
V1M2 5.10.9 Such amendments shall meet all the requirements of this International Standard. X
V1M2 5.10.9
When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces.

X
V1M2 5.10.10 Exceptions N/A
V1M2 5.10.10
Some regulatory reporting requirements or formats, such as monthly operating reports, may not require all items listed in 5.10.2 and 5.10.3 above; however, the laboratory shall provide all the required information to their client for use in preparing such regulatory reports.

X
V1M2 5.10.10
Laboratories operated solely to provide data for compliance purposes (in-house or captive laboratories) shall have all applicable information specified in Section 5.10 readily available for review by the accreditation body.

X
V1M2 5.10.10 However, formal reports detailing the information are not required if: N/A
V1M2 5.10.10.a the in-house laboratory is itself responsible for preparing the regulatory reports; or X
V1M2 5.10.10.b
the laboratory provides information to another individual within the organization for preparation of regulatory reports. The facility management shall ensure that the appropriate report items are in the report to the regulatory authority, if such information is required; or
X
V1M2 5.10.10.c see Section 5.10.1, paragraph 3. N/A
V1M2 5.10.11 Additional Requirements N/A
Citation
Volume 1 Module 2
(V1M2 - Technical)
Does the laboratory comply with this section? Yes No N/A Comments V1M2 5.10.11.a Time of sample preparation and/or analysis if the required holding time for either activity is less than or equal to seventy-two hours. X V1M2 5.10.11.b Results that are reported on a basis other than as received (e. g., dry weight). X
V1M2 5.10.11.c
Any non-accredited tests shall be clearly identified as such to the client when claims of accreditation to this Standard are made in the analytical report or in the supporting electronic or hardcopy deliverables.

X
V1M2 5.10.11.d Clear identification of numerical results with values outside the calibration range. X
TNI 2016 Standard Checklist: Volume 1 Module 4 - Chemical Testing Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1 CHEMICAL TESTING N/A
V1M4 1.1 Introduction N/A
V1M4 1.1
This document contains detailed quality control (QC) requirements for environmental testing activities involving chemical measurements. The evaluation of laboratories for this discipline is in conjunction with a quality system as specified in the general requirements module. Adherence to quality systems requirements will ensure that all QC procedures specified in this module are being followed.

N/A
V1M4 1.2 Scope N/A
V1M4 1.2
The essential QC procedures applicable to chemistry
measurements are included in this module. Additional QC requirements that are either specified by method, regulation or project shall be met by laboratories.

N/A
V1M4 1.3 Terms and Definitions N/A
V1M4 1.3
The relevant definitions from TNI, Volume 1, Module 2, Section 3.0 are the preferred references. Definitions related to this document, which are used differently or do not exist in the above references are defined below.

N/A
V1M4 1.3.1 Additional Terms and Definitions N/A
V1M4 1.3.1 Reserved N/A
V1M4 1.3.2 Exclusions and Exceptions N/A
V1M4 1.3.2 Reserved N/A
V1M4 1.4 Method Selection N/A
V1M4 1.4 Refer to Volume 1, Module 2, Sections 5.4.2, 5.4.3, and 5.4.4. N/A V1M4 1.4
When adding a new analyte to a reference method, the inclusion of the analyte in the method shall meet all required calibration requirements and the QC requirements of the method to which the analyte is being added.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.4
If no QC exists in the method, the laboratory shall adhere to the requirements outlined in a reference method of the same technology (when available). For example, when adding acetone to EPA Method 624, the calibration and QC requirements shall follow EPA Method 624.

X
V1M4 1.4
A method that meets the above requirement shall be identified in such a way so that there is no confusion that the method has been modified.

X
V1M4 1.5 Method Validation N/A
V1M4 1.5.1 Validation of Methods N/A
V1M4 1.5.1 Prior to acceptance and institution of any method for which data will be reported, all methods shall be validated. X
V1M4 1.5.1
The laboratory shall validate reference methods via the procedures specified in Sections 1.5.2 and 1.5.3. For reference methods, the procedures outlined in Section 1.6 can satisfy the requirements of Section 1.5.3.

X
V1M4 1.5.1
For all methods, except reference methods, the validation must comply with Volume 1, Module 2, Sections 5.4.5.1, 5.4.5.2, and

5.4.5.3. This validation must include the minimum requirements outlined in Sections 1.5.2, 1.5.3, and 1.5.4 of this module.

X
V1M4 1.5.1
For both reference and non-standard methods, laboratories shall participate in proficiency testing programs. The results of these analyses shall be used to evaluate the ability of the laboratory to produce acceptable data.

X
V1M4 1.5.2 Limit of Detection and Limit of Quantitation (However Named) N/A V1M4 1.5.2
Procedures used for determining limits of detection and quantitation shall be documented. Documentation shall include the quality system matrix type. All supporting data shall be retained.

X
V1M4 1.5.2.1 Dection Limit (DL) N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.5.2.1
If a mandated test method or applicable regulation includes protocols for determining detection limits, they shall be followed.

The laboratory shall document the procedure used for determining the DL. If the method or regulation does not contain specific directions for determination of the detection limit, the following requirements shall apply. DL determinations are not required for methods/analytes for which a detection limit is not applicable such as pH, color, odor, temperature, or dissolved oxygen. DL determinations based on spikes are not required for analytes for which no spiking solutions are available. If results are not reported below the limit of quantitation (LOQ), an initial DL determination is required, but ongoing verification is not.

X
V1M4 1.5.2.1.1 Initial Determination of the DL N/A
V1M4 1.5.2.1.1
The laboratory DL procedure, unless following a mandated test method or procedure, at a minimum, shall incorporate language addressing the following requirements:

X
V1M4 1.5.2.1.1 a) the DL shall reflect current operating conditions; X V1M4 1.5.2.1.1 b) the DL determination shall incorporate the entire analytical process;
X
V1M4 1.5.2.1.1 c)
the DL determination shall include data from low level spikes and routine method blanks prepared and analyzed over multiple days; at least one low level spike and routine method blank must be analyzed on each applicable instrument; a minimum of seven (7) replicates is required for both low level spikes and routine method blanks;
X
V1M4 1.5.2.1.1 d)
results from low level spikes used in the DL determination shall meet qualitative identification criteria in the method, and shall be above zero;
X
V1M4 1.5.2.1.1 e) the DL procedure shall include criteria for and evaluation of false positive rates in routine method blanks; X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.5.2.1.1 f)
the DL shall be determined for the analytes of interest in each test method in the quality system matrix of interest in which there are neither target analytes nor interferences at a concentration that would impact the results, or the DL shall be performed in the sample matrix of interest.

X
V1M4 1.5.2.1.1 f) N
NOTE: One option is to follow the United States Environmental Protection Agency Method Detection Limit (MDL) procedure, effective September 27, 2017.

X
V1M4 1.5.2.1.2 Ongoing Verification of the DL N/A
V1M4 1.5.2.1.2
At a minimum, ongoing verification of the DL shall include assessments of spikes at or below the LOQ and of method blanks.

A minimum of one (1) verification spike and one (1) blank shall be analyzed on each instrument during each quarter in which samples are being analyzed and results are being reported below the LOQ.

The criteria listed in Section 1.5.2.1.1 shall be met for ongoing verification over the course of a year.

X
V1M4 1.5.2.1.2
If the method is altered in a way other than routine maintenance and the change can be expected to elevate the detection limit, then a spike at or below the LOQ concentration and a blank shall be prepared and analyzed. If the spike at the LOQ concentration gives a result meeting qualitative identification criteria above zero, and the blank gives a result below the DL, then the DL is verified.

If not, the DL shall be re-determined.

X
V1M4 1.5.2.1.2 In the event that verification fails, the laboratory shall perform a new DL study within thirty (30) calendar days. X
V1M4 1.5.2.1.3
When a new DL is determined, the laboratory shall verify that the LOQ value is greater than the DL. If it is not, the laboratory shall raise the LOQ value to greater than the DL.

X
V1M4 1.5.2.2 Limit of Quantitation (LOQ) N/A
V1M4 1.5.2.2
If a mandated test method or applicable regulation includes protocols for determining quantitation limits, they shall be followed. N/A Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.5.2.2
The procedure used for determining the LOQ shall be documented by the laboratory. X
V1M4 1.5.2.2
The laboratory shall select an LOQ for each analyte, consistent with the needs of its clients, and greater than the DL. An LOQ is required for each quality system matrix of interest, technology, method, and analyte, except for any component or property for which spiking solutions are not available or a quantitation limit is not appropriate, such as pH, color, odor, temperature, dissolved oxygen, or turbidity.

X
V1M4 1.5.2.2 a)
Each selected LOQ shall be verified through analysis of initial verification samples. An initial verification sample consists of a spiked matrix blank at or below the selected LOQ.

X
V1M4 1.5.2.2 b) All sample processing and analysis steps performed for routine sample analysis shall be included in the LOQ verification testing. X V1M4 1.5.2.2 c)
The LOQ must be at or above the lowest corresponding calibration standard concentration with the exception of methods using a single point calibration.

X
V1M4 1.5.2.2 d) The laboratory shall establish acceptance criteria for accuracy for the LOQ verification spikes. X
V1M4 1.5.2.2.1 Initial verification of the LOQ N/A
V1M4 1.5.2.2.1
When first establishing an LOQ, or when an LOQ concentration has been selected that is lower than the concentration of the LOQ verification spikes previously performed, an initial verification shall be performed as follows:

N/A
V1M4 1.5.2.2.1 a)
A minimum of seven (7) low level spikes at or below the LOQ concentration shall be processed through all steps of the method.

Both preparation and analysis of these low level spikes shall include at least three (3) batches on three (3) separate days.

X
V1M4 1.5.2.2.1 a)
N1
NOTE 1: Spiking slightly below the LOQ may help ensure that the results are also suitable for DL determination. X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.5.2.2.1 a)
N2
NOTE 2: If low level spikes have been analyzed in order to generate a DL, the results may be used to perform the initial verification of the LOQ.

X
V1M4 1.5.2.2.1 a) i
If there are multiple instruments that will be assigned the same LOQ, then these low level spikes shall be distributed across all of the instruments.

X
V1M4 1.5.2.2.1 a) ii A minimum of two (2) low level spikes prepared and analyzed on different days shall be tested on each instrument. X
V1M4 1.5.2.2.1 b)
Existing data may be used if compliant with the requirements for at least three (3) batches, generated within the last two (2) years and representative of current operations.

X
V1M4 1.5.2.2.1 c) The LOQ is verified if the following criteria are met: N/A V1M4 1.5.2.2.1 c) i
All results are quantitative (above zero and meet the qualitative identification criteria of the method; e.g., recognizable spectra, signal to noise requirements, and presence of qualifier ions).

X
V1M4 1.5.2.2.1 c) i
If a result from an LOQ verification sample is not above zero and/or does not meet the qualitative identification criteria in the method, the problem shall be corrected and the verification repeated, or the LOQ verification shall be repeated at a higher concentration.

X
V1M4 1.5.2.2.1 c) ii Recovery of each analyte is within the laboratory established accuracy acceptance criteria. X
V1M4 1.5.2.2.1 c) iii The LOQ is greater than the established DL and at or above the spiking concentration. X
V1M4 1.5.2.2.1 c) iii If the LOQ is less than or equal to the DL, the LOQ shall be raised to greater than the DL. X
V1M4 1.5.2.2.1 c) iii
N
NOTE: It is not necessary to repeat the LOQ verification at a higher concentration when it is necessary to raise the LOQ to greater than the DL.

N/A
V1M4 1.5.2.2.1 d) The laboratory shall document the results of the initial LOQ verification as described in Section 1.5.2.4. X
V1M4 1.5.2.2.2 Ongoing verification of the LOQ N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.5.2.2.2
The laboratory shall prepare and analyze a minimum of one (1) LOQ verification sample spiked at the same concentration as the initial LOQ verification on each instrument during each quarter in which samples are being analyzed for each quality system matrix, method, and analyte.

X
V1M4 1.5.2.2.2 a)
Results of each LOQ verification sample analysis shall be evaluated at the time of the testing and shall meet the qualitative identification criteria in the method and laboratory Standard Operating Procedure (SOP) and the quantitated result shall be greater than the DL and meet the laboratory established accuracy criteria as established by Section 1.5.2.2 d).

X
V1M4 1.5.2.2.2 b)
If a continuing LOQ verification test does not meet this requirement, the laboratory shall take corrective action and document a technically valid reason for the corrective action.

X
V1M4 1.5.2.2.2 b)
Corrective action shall be one of the following: (i) correcting method or instrument performance and repeating the verification test; (ii) evaluating the laboratory established control limits to ensure they reflect current performance; or (iii) raising the spiking level (and the quantitation limit if the spiking level is above it) and repeating the initial verification study within thirty (30) calendar days of the initial failure.

X
V1M4 1.5.2.2.2 b) Any samples analyzed in a batch associated with a failing LOQ verification shall be reanalyzed or reported with qualifiers. X V1M4 1.5.2.3 Verification of DL/LOQ N/A
V1M4 1.5.2.3
If no analysis was performed in a given year, the verification of the DL/LOQ is not required, but a new initial DL/LOQ verification shall be performed prior to analysis of client samples
X
V1M4 1.5.2.4 Documentation N/A
V1M4 1.5.2.4
At least once per year, the laboratory shall tabulate all results of the ongoing verification sample testing. All data representative of the current operations shall be used, if generated within the last two (2) years. A minimum of seven (7) samples is required.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.5.2.4 a)
The laboratory shall record the analytical and preparation methods used, dates of preparation and testing, the batch identifiers, the testing instrument, quality system matrix, technology, analyte, concentration in the spiked sample with units, and the test result (if any) for each LOQ and/or DL verification test.

X
V1M4 1.5.2.4 b)
For each analyte, the laboratory shall record the percent recovery, the number of results (n), the mean and standard deviation of the percent recovery, and the spiking concentration of the spiked samples with units. These data shall be provided to clients upon request.

X
V1M4 1.5.3 Evaluation of Precision and Bias N/A
V1M4 1.5.3 a)
Reference Methods. The laboratory shall evaluate the precision and bias of a reference method for each analyte of concern for each quality system matrix according to Section 1.6 or alternate documented procedure when the analyte cannot be spiked into the sample matrix and QC samples are not commercially available.

X
V1M4 1.5.3 b)
Non-Reference Methods. For laboratory-developed methods or non-reference methods that were not in use by the laboratory before July 2003, the laboratory shall have a documented procedure to evaluate precision and bias. The laboratory shall also compare results of the precision and bias measurements with criteria established by the client, by criteria given in the reference method or criteria established by the laboratory.

X
V1M4 1.5.3 b)
Precision and bias measurements shall evaluate the method across the analytical calibration range of the method. The laboratory shall also evaluate precision and bias in the relevant quality system matrices and shall process the samples through the entire measurement system for each analyte of interest.

X
V1M4 1.5.3 b) Examples of a systematic approach to evaluate precision and bias could be the following: N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.5.3 b) i.

Analyze QC samples in triplicate containing the analytes of concern at or near the LOQ, at the upper-range of the calibration (upper 20%) and at a mid-range concentration. Process these samples on different days as three (3) sets of samples through the entire measurement system for each analyte of interest. Each day, one (1) QC sample at each concentration is analyzed. A separate method blank shall be subjected to the analytical method along with the QC samples on each of the three (3) days. (Note that the three (3) samples at the LOQ concentration can demonstrate sensitivity as well.) For each analyte, calculate the mean recovery for each day, for each level over each day, and for all nine (9) samples. Calculate the relative standard deviation for each of the separate means obtained. Compare the standard deviations for the different days and the standard deviations for the different concentrations. If the different standard deviations are all statistically insignificant (e.g., F-test), then compare the overall mean and standard deviation with the established criteria from above.

X
V1M4 1.5.3 b) ii.

A validation protocol, such as the Tier I, Tier II, and Tier III requirements in US EPA Office of Water’s Alternate Test Procedure (ATP) approval process.

X
V1M4 1.5.4 Evaluation of Selectivity N/A
V1M4 1.5.4
The laboratory shall evaluate selectivity by following the checks established within the method, which may include mass spectral tuning, second column confirmation, ICP inter-element interference checks, chromatography retention time windows, sample blanks, spectrochemical absorption or fluorescence profiles, coprecipitation evaluations, and electrode response factors.

X
V1M4 1.6 Demonstration of Capability (DOC) N/A
V1M4 1.6.1 General N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.6.1 a)
An individual who performs any activity involved with preparation and/or analysis of samples must have constant, close supervision (as defined in the laboratory's training procedure) until a satisfactory initial DOC is completed (see Section 1.6.2).

X
V1M4 1.6.1 b)
Thereafter, ongoing DOC (Section 1.6.3), as per the QC
requirements in Section 1.7.2 (such as laboratory control samples) is required.

X
V1M4 1.6.1 c)
In cases where an individual has prepared and/or analyzed samples using a method that has been in use by the laboratory for at least one (1) year prior to applying for accreditation, and there have been no significant changes in instrument type or method, the ongoing DOC shall be acceptable as an initial DOC.

X
V1M4 1.6.1 c) The laboratory shall have records on file to demonstrate that an initial DOC is not required. X
V1M4 1.6.1 All demonstrations shall be documented. . X
V1M4 1.6.1 All data applicable to the demonstration shall be retained and readily available at the laboratory. X
V1M4 1.6.2 Initial DOC N/A
V1M4 1.6.2
An individual must successfully perform an initial DOC prior to using any method (see Section 1.6.1.a above), and any time there is a change in instrument type, method, or any time that a method has not been performed by the analyst in a twelve (12) month period.

X
V1M4 1.6.2.1
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee:

X
V1M4 1.6.2.1 a) analyst(s) involved in preparation and/or analysis; X V1M4 1.6.2.1 b) matrix; X
V1M4 1.6.2.1 c) analyte(s), class of analyte(s); X
V1M4 1.6.2.1 d) identification of method(s) performed; X V1M4 1.6.2.1 e) identification of laboratory-specific SOP used for analysis, including revision number; X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.6.2.1 f) date(s) of analysis; and X
V1M4 1.6.2.1 g) summary of analyses, including information outlined in Section

1.6.2.2.c. X
V1M4 1.6.2.2
If the method or regulation does not specify an initial DOC, the following procedure is acceptable. It is the responsibility of the laboratory to document that other approaches to initial DOC are adequate.

X
V1M4 1.6.2.2 a)
The analyte(s) shall be diluted in a volume of clean quality system matrix (a sample in which no target analytes or interferences are present at concentrations that will impact the results of a specific method) sufficient to prepare four (4) aliquots at the concentration specified, or if unspecified, to a concentration of one (1) to four (4) times the limit of quantitation.

X
V1M4 1.6.2.2 b) At least four (4) aliquots shall be prepared and analyzed according to the method(s) either concurrently or over a period of days. X V1M4 1.6.2.2 c)
Using all of the results, calculate the mean recovery in the appropriate reporting units and the standard deviations of the sample (in the same units) for each analyte of interest. When it is not possible to determine mean and standard deviations, such as for presence/absence and logarithmic values, the laboratory shall assess performance against established and documented criteria.

X
V1M4 1.6.2.2 d)
Compare the information from (c) above to the corresponding acceptance criteria for precision and accuracy in the method (if applicable) or in laboratory-generated acceptance criteria (if there are not established mandatory criteria). If all analytes meet the acceptance criteria, the analysis of actual samples may begin. If any one of the analytes does not meet the acceptance criteria, the performance is unacceptable for that analyte.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.6.2.2 e)
When one or more of the tested analytes fail at least one (1) of the acceptance criteria, the analyst shall proceed according to i) or ii) below.

X
V1M4 1.6.2.2 e) i. Locate and correct the source of the problem and repeat the test for all analytes of interest beginning with b) above. X V1M4 1.6.2.2 e) ii. Beginning with b) above, repeat the test for all analytes that failed to meet criteria. X
V1M4 1.6.2.2 f)
Repeated failure, however, confirms a general problem with the measurement system. If this occurs, locate and correct the source of the problem and repeat the test for all analytes of interest beginning with b).

X
V1M4 1.6.2.2 g)
When an analyte not currently found on the laboratory’s list of accredited analytes is added to an existing accredited method, an initial demonstration shall be performed for that analyte.

X
V1M4 1.6.3 Ongoing DOC N/A
V1M4 1.6.3.1
The laboratory shall have a documented procedure describing ongoing DOC that includes procedures for how the laboratory will identify data associated with on-going DOCs. The analyst(s) shall demonstrate on-going capability by routinely meeting the QC requirements of the method, laboratory SOP, client specifications, and/or this Standard.

X
V1M4 1.6.3.1
If the method has not been performed by the analyst in a twelve (12) month period, an initial DOC (Section V1M4 1.6.2) shall be performed.

X
V1M4 1.6.3.1 It is the responsibility of the laboratory to document that other approaches to ongoing DOC are adequate. X
V1M4 1.6.3.2 This on-going demonstration may be one of the following: N/A Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.6.3.2 a)
acceptable performance of a blind sample (single blind to the analyst), or successful analysis of a blind performance sample on a similar method using the same technology (e.g., GC/MS volatiles by purge and trap for Methods 524.2, 624 or 5030/8260) would only require documentation for one of the tests.

X
V1M4 1.6.3.2 b) another initial DOC; X
V1M4 1.6.3.2 c)
at least four (4) consecutive laboratory control samples with acceptable levels of precision and accuracy. The laboratory shall determine the acceptable limits for precision and accuracy prior to analysis. The laboratory shall tabulate or be able to readily retrieve four (4) consecutive passing LCSs for each method for each analyst each year;
X
V1M4 1.6.3.2 d)
a documented process of reviewing QC samples performed by an analyst or groups of analysts relative to the QC requirements of the method, laboratory SOP, client specifications, and/or this Standard. This review can be used to identify patterns for individuals or groups of analysts and determine if corrective action or retraining is necessary;
X
V1M4 1.6.3.2 e)
if a) through d) are not technically feasible, then analysis of realworld samples with results within a predefined acceptance criterion (as defined by the laboratory or method) shall be performed.

X
V1M4 1.7 Technical Requirements N/A
V1M4 1.7.1 Calibration N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1
This module specifies the essential elements that shall define the procedures and documentation for initial calibration with second source verification and continuing calibration verification for methods that use calibration models including, but not limited to, average response factor or linear or quadratic regression, to ensure that the data shall be of known quality for the intended use. Calibration requirements for analytical support equipment are specified in Module 2. This Standard does not specify detailed procedural steps (“how to”) for calibration, but establishes the essential elements for selection of the appropriate technique(s).

This approach allows flexibility and permits the employment of a wide variety of analytical procedures and statistical approaches currently applicable for calibration.

N/A
V1M4 1.7.1
If more stringent standards or requirements are included in a mandated method or by regulation, the laboratory shall
demonstrate that such requirements are met. If it is not apparent which Standard is more stringent, then the requirements of the regulation or mandated method are to be followed.

X
V1M4 1.7.1.1 Initial Calibration N/A
V1M4 1.7.1.1
Samples shall be associated with an acceptable initial calibration.

If the initial calibration is not acceptable, corrective actions shall be performed and all associated samples re-analyzed. If re-analysis of the samples is not possible, data associated with an unacceptable initial calibration shall only be reported with appropriate data qualifiers.

X
V1M4 1.7.1.1 The following items are essential elements of initial instrument calibration: N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1.1 a)
the details of the initial calibration procedures including calculations, integrations, acceptance criteria, and associated statistics shall be included or referenced in the method SOP.

When initial calibration procedures are referenced in the test method, then the referenced material shall be retained by the laboratory and be available for review
X
V1M4 1.7.1.1 b)
sufficient raw data records shall be retained to permit reconstruction of the initial calibration (e.g., calibration date, method, instrument, analysis date, each analyte name, and analyst’s initials or signature; concentration and response, calibration curve or response factor; or unique equation or coefficient used to reduce instrument responses to concentration); X
V1M4 1.7.1.1 c)
the laboratory shall use the most recent initial calibration analyzed prior to the analytical batch, unless otherwise specified by the method
X
V1M4 1.7.1.1 d) standards used for calibration shall be traceable to a national standard, when commercially available X
V1M4 1.7.1.1 e)
the laboratory shall have a written procedure addressing removal and replacement of calibration standards. The procedure shall comply with the following requirements:

X
V1M4 1.7.1.1 e).i
The laboratory may remove individual analyte calibration levels from the lowest and/or highest levels of the curve. Multiple levels may be removed, but removal of interior levels is not permitted X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1.1 e).ii
The laboratory may remove an entire single standard calibration level from the interior of the calibration curve when the instrument response demonstrates that the standard was not properly introduced to the instrument, or an incorrect standard was analyzed. A laboratory that chooses to remove a calibration standard from the interior of the calibration shall remove that particular standard calibration level for all analytes. Removal of calibration points from the interior of the curve is not to be used to compensate for lack of maintenance or repair to the instrument X

1.7.1.1 e).iii
The laboratory shall adjust the LOQ/reporting limit and quantitation range of the calibration based on the concentration of the remaining high and low calibration standards
X
V1M4 1.7.1.1 e).iv
The laboratory shall ensure that the remaining initial calibration standards are sufficient to meet the minimum requirements for number of initial calibration points as mandated by this Standard, the method, or regulatory requirements
X
V1M4 1.7.1.1 e).v.a
The laboratory may replace a calibration standard provided that the laboratory analyzes the replacement standard within twentyfour (24) hours of the original calibration standard analysis for that particular calibration level
X
V1M4 1.7.1.1 e).v.b
The laboratory may replace a calibration standard provided that the laboratory replaces all analytes of the replacement calibration standard if a standard within the interior of the calibration is replaced
X
V1M4 1.7.1.1 e).v.c
The laboratory may replace a calibration standard provided that the laboratory limits the replacement of calibration standards to one calibration standard concentration
X
V1M4 1.7.1.1 e).vi The laboratory shall document a technically valid reason for either removal or replacement of any interior calibration point X Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1.1 f)
For regression or average response/calibration factor calibrations, the minimum number of non-zero calibration standards shall meet the following specifications: threshold testing, 1 standard; average response, 4 standards; linear fit, 5 standards; quadratic fit, 6 standards.

X
V1M4 1.7.1.1 f) The initial one-point calibration shall be at the project specified threshold level. X
V1M4 1.7.1.1 f)
Fewer calibration standards may be used only if equipment firmware or software cannot accommodate the specified number of standards. Documentation detailing that limitation shall be maintained by the laboratory.

X
V1M4 1.7.1.1 g)
The lowest calibration standard shall be at or below the lowest concentration for which quantitative data are to be reported without qualification.

X
V1M4 1.7.1.1 h)
The highest calibration standard shall be at or above the highest concentration for which quantitative data are to be reported without qualification.

X
V1M4 1.7.1.1 i)
Sample results shall be quantitated from the initial calibration and may not be quantitated from any continuing calibration verification unless otherwise required by regulation, method, or program X
V1M4 1.7.1.1 j)
Criteria for the acceptance of an initial calibration shall be established (e.g., correlation coefficient or relative standard deviation).

X pH slope did not have
acceptability
V1M4 1.7.1.1 k) The laboratory shall use and document a measure of relative error in the calibration. X
V1M4 1.7.1.1 k) i
For calibrations evaluated using an average response factor, the determination of the relative standard deviation (RSD) is the measure of the relative error. X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1.1 k) ii
For calibrations evaluated using correlation coefficient or coefficient of determination, the laboratory shall evaluate relative error by either: measurement of the Relative Error (%RE); or measurement of the relative Standard Error (%RSE).

X
V1M4 1.7.1.1 k) ii
The calculation of RE shall be performed for two (2) calibration levels: the standard at or near the mid-point of the initial calibration and the standard at the lowest level. The Relative Error at both of these levels shall meet the criteria specified in the method. If no criterion for the lowest calibration level is specified in the method, the criterion and the procedure for deriving the criterion shall be specified in the laboratory SOP.

X
V1M4 1.7.1.1 k) ii
The RSE shall meet the criterion specified in the method. If no criterion is specified in the method, the maximum allowable RSE shall be numerically identical to the requirement for RSD in the method. If there is no specification for RSE or RSD in the method, then the RSE shall be specified in the laboratory SOP.

X
V1M4 1.7.1.1 l)
When test procedures are employed that specify calibration with a single calibration standard and a zero point (blank or zero, however specified by the method), the zero point and single calibration standard within the linear range shall be analyzed at least daily and used to establish the slope of the calibration.

X
V1M4 1.7.1.1 l)
When test procedures are employed that specify calibration with a single calibration standard and a zero point (blank or zero, however specified by the method), to verify adequate sensitivity a standard shall be analyzed at or below the lowest concentration for which quantitative data are to be reported without qualification.

This standard shall be analyzed prior to sample analysis with each calibration and shall meet the quantitation limit criteria established by the method. If no criteria exist the laboratory shall specify criteria in the SOP;
X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments

1.7.1.1 m)
For analysis of Aroclors which use a linear through origin model (or average response factor) the minimum requirement is to perform an initial multi-point calibration for a subset of Aroclors (e.g., a mixture of 1016/1260) and to use a one-point initial calibration to determine the calibration factor and pattern recognition for the remaining Aroclors;
X
V1M4 1.7.1.1 n)
All initial calibrations shall be verified with a standard obtained from a second manufacturer or a separate lot prepared independently by the same manufacturer;
X
V1M4 1.7.1.1 o)
For those methods where reporting non-detected analytes based on successful completion of a sensitivity check is allowed (similar to threshold testing but only for non-detects) the requirements of this Standard shall not prohibit the practice.

X
V1M4 1.7.1.1 p)
For methods that allow data within the linear range of the instrument, but above the daily calibration, to be reported without qualification, the laboratory shall establish the upper reporting limit through analysis of a series of standards. The upper reporting limit is equal to the concentration of the highest standard meeting the method limits for accuracy. The laboratory shall establish linearity annually and check it at least quarterly with a standard at the top of the linear working range, or at the frequency defined by the method. The laboratory shall dilute samples with results above the linear calibration range, or qualify the over-range results as estimated values.

X
V1M4 1.7.1.2 Continuing Calibration Verification (CCV) N/A V1M4 1.7.1.2
The validity of the initial calibration shall be verified prior to sample analyses by a continuing calibration verification with each analytical batch. The following items are essential elements of continuing calibration verification.

X
V1M4 1.7.1.2 a)
The details of the continuing calibration procedure, calculations and associated statistics shall be included or referenced in the method SOP.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1.2 b)
Calibration shall be verified for each compound, element, or other discrete chemical species, except for multi-component analytes such as Aroclors, chlordane, total petroleum hydrocarbons, or toxaphene, where a representative chemical, related substance or mixture can be used.

X
V1M4 1.7.1.2 c) The concentration of the calibration verification standard shall be equal to or less than half the highest level in the calibration. X

1.7.1.2 d)
Instrument continuing calibration verification shall be performed at the beginning and end of each analytical batch, and at the frequency defined in the method except:
i. if an internal standard is used, calibration verification shall be performed at the beginning of each analytical batch, and at the frequency defined in the method;
ii. a second source initial calibration verification that passes the continuing calibration verification criteria may be used in place of a continuing calibration verification standard;
iii. a laboratory control sample (LCS) may be used in place of a continuing calibration verification (but not as a replacement for a failing CCV) for methods where the calibration goes through the same process as the LCS (using the continuing calibration verification acceptance criteria).

X
V1M4 1.7.1.2 e)
Sufficient raw data records shall be retained to permit reconstruction of the continuing instrument calibration verification (e.g., method, instrument, analysis date, each analyte name, concentration and response, calibration curve or response factor, or unique equations or coefficients used to convert instrument responses into concentrations). Continuing calibration verification records shall explicitly connect the continuing calibration verification data to the initial calibration.

X
V1M4 1.7.1.2 f) Criteria for the acceptance of a continuing instrument calibration verification shall be established. X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1.2 f)
If the continuing instrument calibration verification results obtained are outside the established acceptance criteria, the following steps shall be taken:

N/A
V1M4 1.7.1.2 f) i
if a cause for the calibration verification failure is identified that impacts only the calibration verification sample (e.g. a missed autosampler injection), then analysis may proceed if a second calibration verification sample is analyzed immediately and the result is within acceptance criteria. Samples analyzed previously shall be considered valid if bracketed by a passing calibration verification sample (refer to 1.7.1.2.d). The cause for the failure of the first calibration verification result shall be documented; X
V1M4 1.7.1.2 f) ii
if the cause for the calibration verification failure is not identifiable or has impacted other samples, then corrective action shall be performed and documented. Prior to analyzing samples, the laboratory shall demonstrate acceptable performance after corrective action with calibration verification or a new initial calibration shall be performed. Samples analyzed prior to the calibration verification failure shall be reanalyzed or the results qualified if calibration verification bracketing is required (refer to

1.7.1.2.d);
X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.1.2 f) iii
Data associated with an unacceptable calibration verification shall be qualified if reported, and shall not be reported if prohibited by the client, a regulatory program or regulation. Data associated with calibration verifications that fail under the following special conditions shall still be qualified, but may use a different qualifier:
a. when the acceptance criteria for the continuing calibration verification are exceeded high (i.e., high bias) and there are associated samples that are non-detects, then those non-detects may be reported. Otherwise, the samples affected by the unacceptable calibration verification shall be re-analyzed after a new calibration curve has been established, evaluated and accepted; or
b. when the acceptance criteria for the continuing calibration verification are exceeded low (i.e., low bias), those sample results may be reported if they exceed a maximum regulatory limit/decision level. Otherwise the samples affected by the unacceptable verification shall be re-analyzed after a new calibration curve has been established, evaluated and accepted.

X

1.7.2 Quality Control N/A

1.7.2 The laboratory shall have QC procedures for monitoring the validity of environmental tests undertaken as specified in this Section.(see requirements below)
N/A
V1M4 1.7.2.1 Negative Control – Method Performance: Method Blank N/A V1M4 1.7.2.1 a)
The method blank is used to assess the samples in the
preparation batch for possible contamination during the preparation and processing steps.

X
V1M4 1.7.2.1 a)
The method blank shall be processed along with and under the same conditions as the associated samples to include all steps of the analytical procedure.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.2.1 a) Procedures shall be in place to determine if a method blank is contaminated. X
V1M4 1.7.2.1 a)
Any affected samples associated with a contaminated method blank shall be reprocessed for analysis or the results reported with appropriate data qualifying codes.

X
V1M4 1.7.2.1 b) The method blank shall be analyzed at a minimum of one (1) per preparation batch. X
V1M4 1.7.2.1 b)
In those instances for which no separate preparation method is used (for example, volatiles in water), the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of twenty (20) environmental samples, not including method blanks, LCS, matrix spikes and matrix duplicates.

X
V1M4 1.7.2.1 c)
The method blank shall consist of a quality system matrix that is similar to the associated samples and is known to be free of the analytes of interest.

X
V1M4 1.7.2.1 d) Method blanks are not applicable for certain analyses, such as pH, Conductivity, Flash Point and Temperature. N/A
V1M4 1.7.2.2 Positive Control – Method Performance: Laboratory Control Sample (LCS) N/A
V1M4 1.7.2.2.1
The LCS is used to evaluate the performance of the total analytical system, including all preparation and analysis steps.

Results of the LCS are compared to established criteria and, if found to be outside of these criteria, indicates that the analytical system is “out of control.” Any affected samples associated with an out of control LCS shall be reprocessed for re-analysis or the results reported with appropriate data qualifying codes.

X
V1M4 1.7.2.2.2 The LCS shall be analyzed at a minimum of one (1) per preparation batch. X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.2.2.2
Exceptions would be for those analytes for which no spiking solutions are available, such as total suspended solids, total dissolved solids, total volatile solids, total solids, pH, color, odor, temperature, dissolved oxygen or turbidity.

X
V1M4 1.7.2.2.2
In those instances for which no separate preparation method is used (example: volatiles in water) the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of twenty (20) environmental samples, not including method blanks, LCS, matrix spikes and matrix duplicates.

X
V1M4 1.7.2.2.3 The LCS is a quality system matrix, known to be free of analytes of interest, spiked with known concentrations of analytes. X V1M4 1.7.2.2.3 N NOTE: The matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS. X V1M4 1.7.2.2.3
Alternatively, the LCS may consist of a media containing known and verified concentrations of analytes or as Certified Reference Material (CRM). All analyte concentrations shall be within the calibration range of the methods. The following shall be used in choosing components for the spike mixtures:

X
V1M4 1.7.2.2.3
The components to be spiked shall be as specified by the mandated method or regulation or as requested by the client. In the absence of specified spiking components, the laboratory shall spike per the following:

X
V1M4 1.7.2.2.3 a)
for those components that interfere with an accurate assessment, such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike shall be chosen that represents the chemistries and elution patterns of the components to be reported; and
X
V1M4 1.7.2.2.3 b)
for those methods that have extremely long lists of analytes, a representative number may be chosen. The analytes selected shall be representative of all analytes reported.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.2.2.3 b)
The following criteria shall be used for determining the minimum number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two (2) year period:

X
V1M4 1.7.2.2.3 b) i. For methods that include one (1) to ten (10) targets, spike all components.

X
V1M4 1.7.2.2.3 b) ii. For methods that include eleven (11) to twenty (20) targets, spike at least ten (10) or 80%, whichever is greater. X
V1M4 1.7.2.2.3 b) iii. For methods with more than twenty (20) targets, spike at least sixteen (16) components. X
V1M4 1.7.2.3 Sample Specific Controls N/A
V1M4 1.7.2.3
The laboratory shall document procedures for determining the effect of the sample matrix on method performance. These procedures relate to the analyses of quality system matrix specific QC samples and are designed as data quality indicators for a specific sample using the designated method. These controls alone are not used to judge laboratory performance.

X
V1M4 1.7.2.3
Examples of matrix-specific QC include: Matrix Spike (MS), Matrix Spike Duplicate (MSD), sample duplicates, and surrogate spikes.

The laboratory shall have procedures in place for tracking, managing, and handling matrix-specific QC criteria, including spiking appropriate components at appropriate concentrations, calculating recoveries and relative percent difference, and evaluating and reporting results based on performance of the QC samples.

X
V1M4 1.7.2.3.1 Matrix Spike; Matrix Spike Duplicates N/A V1M4 1.7.2.3.1 a)
Matrix-specific QC samples indicate the effect of the sample matrix on the precision and accuracy of the results generated using the selected method. The information from these controls is sample/matrix specific and would not normally be used to determine the validity of the entire batch.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.2.3.1 b)
The frequency of the analysis of matrix spikes are as specified by the method or may be determined as part of the contract review process.

X
V1M4 1.7.2.3.1 c)
The components to be spiked shall be as specified by the mandated method. Any permit specified analytes, as specified by regulation or client requested analytes, shall also be included. If there are no specified components, the laboratory shall spike per the following:

X
V1M4 1.7.2.3.1 c) i.

For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike shall be chosen that represents the chemistries and elution patterns of the components to be reported.

X
V1M4 1.7.2.3.1 c) ii.

For those methods that have extremely long lists of analytes, a representative number may be chosen using the following criteria for choosing the number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two (2) year period.

X
V1M4 1.7.2.3.1 c) i. For methods that include one (1) to ten (10) targets, spike all components.

X
V1M4 1.7.2.3.1 c) ii. For methods that include eleven (11) to twenty (20) targets, spike at least ten (10) or 80%, whichever is greater. X
V1M4 1.7.2.3.1 c) iii. For methods with more than twenty (20) targets, spike at least sixteen (16) components. X
V1M4 1.7.2.3.2 Matrix Duplicates N/A
V1M4 1.7.2.3.2 a)
Matrix duplicates are defined as replicate aliquots of the same sample taken through the entire analytical procedure. The results from this analysis indicate the precision of the results for the specific sample using the selected method. The matrix duplicate may provide a usable measure of sample homogeneity. It may also provide a measure of precision when target analytes are present.

N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.2.3.2 b)
The frequency of the analysis of matrix duplicates are as specified by the method or may be determined as part of the contract review process.

X
V1M4 1.7.2.3.2 c) Matrix duplicates are performed on replicate aliquots of actual samples. The composition is usually not known. X
V1M4 1.7.2.3.3 Surrogate Spikes N/A
V1M4 1.7.2.3.3 a)
Surrogates, when required, are chosen to reflect the chemistries of the targeted components of the method and are added prior to sample preparation/extraction.

X
V1M4 1.7.2.3.3 b)
Except where the matrix precludes its use or when not
commercially available, surrogate compounds shall be added to all samples, standards, and blanks for all appropriate methods.

X
V1M4 1.7.2.3.3 c)
Surrogate compounds are chosen to represent the various chemistries of the target analytes in the method. They are often specified by the mandated method and are deliberately chosen for their being unlikely to occur as an environmental contaminant.

Often this is accomplished by using deuterated analogs of select compounds.

X
V1M4 1.7.2.4 Data Reduction N/A
V1M4 1.7.2.4 The procedures for data reduction, such as use of linear regression, shall be documented. X
V1M4 1.7.2.5 Reagent Quality, Water Quality and Checks N/A V1M4 1.7.2.5 a)
In methods where the purity of reagents is not specified, analytical reagent grade shall be used. Reagents of lesser purity than those specified by the method shall not be used. Documentation of purity shall be available.

X
V1M4 1.7.2.5 b) The quality of water sources shall be monitored and documented and shall meet method specified requirements. X
V1M4 1.7.2.5 c) The laboratory shall verify the concentration of titrants in accordance with written laboratory procedures. X
V1M4 1.7.2.6 Selectivity N/A
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.2.6 The laboratory shall document selectivity by following the checks established within the method. X
V1M4 1.7.3 Data Acceptance/Rejection Criteria N/A
V1M4 1.7.3.1 Negative Control – Method Performance: Method Blank N/A V1M4 1.7.3.1
While the goal is to have no detectable contaminants, each method blank shall be critically evaluated as to the nature of the interference and the effect on the analysis of each sample within the batch.

X
V1M4 1.7.3.1
The source of contamination shall be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed or data shall be appropriately qualified if:

N/A
V1M4 1.7.3.1 a)
the concentration of a targeted analyte in the blank is at or above the reporting limit as established by the method or by regulation, AND is greater than 1/10 of the amount measured in the sample; X
V1M4 1.7.3.1 b)
the blank contamination otherwise affects the sample results as per the method requirements or the individual project data quality objectives;
X
V1M4 1.7.3.1 c)
and a blank is determined to be contaminated. The cause shall be investigated and measures taken to minimize or eliminate the problem. Samples associated with a contaminated blank shall be evaluated as to the best corrective action for the samples (e.g., reprocessing or data qualifying codes). In all cases the corrective action shall be documented.

X
V1M4 1.7.3.2 Positive Control – Method Performance: Laboratory Control Sample (LCS) N/A
V1M4 1.7.3.2 a)
The results of the individual batch LCS are calculated in percent recovery or other appropriate statistical technique that allows comparison to established acceptance criteria. The laboratory shall document the calculation.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.3.2 a)
The individual LCS is compared to the acceptance criteria as published in the mandated method. Where there are no
established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits or utilize client specified assessment criteria.

X
V1M4 1.7.3.2 a)
An LCS that is determined to be within the criteria effectively establishes that the analytical system is in control and validates system performance for the samples in the associated batch.

Samples analyzed along with an LCS determined to be “out of control” shall be considered suspect and the samples reprocessed and re-analyzed or the data reported with appropriate data qualifying codes. This includes any allowable marginal exceedance as described in b) below.

X
V1M4 1.7.3.2 a) i.
when the acceptance criteria for the positive control are exceeded high (i.e., high bias) and there are associated samples that are non-detects, then those non-detects may be reported with data qualifying codes; or
X
V1M4 1.7.3.2 a) ii.
when the acceptance criteria for the positive control are exceeded low (i.e., low bias), those sample results may be reported if they exceed a maximum regulatory limit/decision level with data qualifying codes.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.3.2 b)
Allowable Marginal Exceedances. If a large number of analytes are in the LCS, it becomes statistically likely that a few will be outside control limits. This may not indicate that the system is out of control, therefore corrective action may not be necessary. Upper and lower marginal exceedance (ME) limits can be established to determine when corrective action is necessary. A ME is defined as being beyond the LCS control limit (three standard deviations), but within the ME limits. ME limits are between three (3) and four (4) standard deviations around the mean. The number of allowable marginal exceedances is based on the number of analytes in the LCS. If more analytes exceed the LCS control limits than is allowed, or if any one analyte exceeds the ME limits, the LCS fails and corrective action is necessary. This marginal exceedance approach is relevant for methods with long lists of analytes. It will not apply to target analyte lists with fewer than eleven analytes.

X
V1M4 1.7.3.2 b) The number of allowable marginal exceedances is as follows: N/A V1M4 1.7.3.2 b) Number of Analytes in LCS >90 Number Allowed as Marginal Exceedances 5 X
V1M4 1.7.3.2 b) Number of Analytes in LCS 71-90 Number Allowed as Marginal Exceedances 4 X
V1M4 1.7.3.2 b) Number of Analytes in LCS 51-70 Number Allowed as Marginal Exceedances 3 X
V1M4 1.7.3.2 b) Number of Analytes in LCS 31-50 Number Allowed as Marginal Exceedances 2 X
V1M4 1.7.3.2 b) Number of Analytes in LCS 11-30 Number Allowed as Marginal Exceedances 1 X
V1M4 1.7.3.2 b) Number of Analytes in LCS <11 Number Allowed as Marginal Exceedances 0 X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.3.2 b)
If the same analyte exceeds the LCS control limit consecutively, it is an indication of a systemic problem. The source of the error shall be located and corrective action taken. Laboratories shall have a written procedure to monitor the application of marginal exceedance allowance to the LCS.

X
V1M4 1.7.3.3 Sample Specific Controls N/A
V1M4 1.7.3.3 a) Matrix Spike; Matrix Spike Duplicates N/A V1M4 1.7.3.3 a)
The results from matrix spike/matrix spike duplicate are primarily designed to assess the precision and accuracy of analytical results in a given matrix and are expressed as percent recovery (%R), relative percent difference (RPD), or other appropriate statistical technique that allows comparison to established acceptance criteria. The laboratory shall document the calculation for %R, RPD or other statistical treatment used.

X
V1M4 1.7.3.3 a)
The results are compared to the acceptance criteria as published in the mandated method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits. For matrix spike results outside established criteria, corrective action shall be documented or the data for that sample reported with appropriate data qualifying codes.

X
V1M4 1.7.3.3 b) Matrix Duplicates N/A
V1M4 1.7.3.3 b)
The results from matrix duplicates are primarily designed to assess the homogeneity of the particular sample chosen. If that sample is homogenous it may also describe the precision of analytical results in a given matrix.

N/A
V1M4 1.7.3.3 b)
These may be expressed as relative percent difference (RPD) or another statistical treatment (e.g., absolute differences). The laboratory shall document the calculation for relative percent difference or other statistical treatments.

X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.3.3 b)
Results are compared to the acceptance criteria as published in the mandated method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits. For matrix duplicates results outside established criteria, corrective action shall be documented or the data for that sample reported with appropriate data qualifying codes.

X
V1M4 1.7.3.3 c) Surrogate Spikes N/A
V1M4 1.7.3.3 c)
The results are compared to the acceptance criteria as published in the mandated method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits.

X
V1M4 1.7.3.3 c)
Surrogates outside the acceptance criteria shall be evaluated for the effect indicated for the individual sample results. The appropriate corrective action may be guided by the data quality objectives or other site-specific requirements.

X
V1M4 1.7.3.3 c) Results reported from analyses with surrogate recoveries outside the acceptance criteria shall include appropriate data qualifiers. X V1M4 1.7.4 Sample Handling N/A
V1M4 1.7.4 a)
All samples that require thermal preservation shall be considered acceptable if the arrival temperature of a representative sample container is either within 2°C of the required temperature or the method specified range. For samples with a specified temperature of 4°C, samples with a temperature ranging from just above the freezing temperature of water to 6°C shall be acceptable.

X
V1M4 1.7.4 a) i.

Samples that are delivered to the laboratory on the same day they are collected may not meet the requirements of Section 1.7.4.a. In these cases, the samples shall be considered acceptable if the samples were received on ice.

X
V1M4 1.7.4 a) ii. If sample analysis is begun within fifteen (15) minutes of collection, thermal preservation is not required. X
Citation
Volume 1 Module 4
(V1M4 - Chemistry)
Does the laboratory comply with this section? Yes No N/A Comments V1M4 1.7.4 a) iii.

Thermal preservation is not required in the field if the laboratory receives and refrigerates the sample within fifteen (15) minutes of collection.

X
V1M4 1.7.4 b)
The laboratory shall implement procedures for checking sample preservation using readily available techniques, such as pH or chlorine, prior to or during sample preparation or analysis.

X
V1M4 1.7.4 b) An exception is allowed for volatile organic compound analyses; chemical preservation may be checked after analysis. X
TNI 2016 Standard Checklist: Volume 1 Module 5 - Microbiological Testing Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1 MICROBIOLOGICAL TESTING N/A
V1M5 1.1 Introduction N/A
V1M5 1.1
This Standard applies to laboratories undertaking microbiological analysis of environmental samples. Microbiological testing refers to and includes the detection, isolation, enumeration, or identification of microorganisms (and/or their metabolites), or determination of the presence or absence of growth in materials and media. The evaluation of laboratories for this discipline is in conjunction with a quality system as specified in the general requirements module. Adherence to those quality system
requirements and all quality control (QC) procedures specified in this module will ensure that microbiological test results are fit for the intended use.

N/A
V1M5 1.2 Scope N/A
V1M5 1.2
The essential QC procedures applicable to microbiological analysis are included in this module. Additional QC or program requirements that are either specified by method, regulation or project shall be met by laboratories.

N/A
V1M5 1.3 Terms and Definitions N/A
V1M5 1.3
The relevant definitions from TNI, Volume 1, Module 2, Section

3.0 apply. Definitions related to this document, which are used differently or do not exist in the above references, are defined below.

N/A
V1M5 1.3.1 Additional Terms and Definitions N/A
V1M5 1.3.1
Source Water: When sampled for drinking water compliance, untreated water from streams, rivers, lakes, or underground aquifers which is used to supply private and public drinking water supplies.

N/A
V1M5 1.3.2 Exclusions and Exceptions- Reserved N/A
V1M5 1.4 Method Selection N/A
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.4 Refer to Volume 1, Module 2, Sections 5.4.2, 5.4.3, and 5.4.4. N/A V1M5 1.5 Method Validation N/A
V1M5 1.5.a)
For methods other than reference methods, validation must comply with Volume 1, Module 2. This validation must include the minimum requirements outlined in Sections 1.5.1, 1.5.2, and 1.5.3 of this module.

X
V1M5 1.5.b) For both reference and non-standard methods, laboratories shall participate in proficiency testing (PT) programs, where available X V1M5 1.5.c)
The laboratory shall maintain documentation of the validation procedure for as long as the method is in use, and for at least five (5) years past the date of last use.

X
V1M5 1.5.1
Accuracy – Use at least one (1) known pure positive reference culture at the anticipated environmental conditions and compare the method results to that of a reference method.

X
V1M5 1.5.2
Precision – Perform at least ten (10) replicate analyses with both the proposed and reference method, using a sample containing the target microorganisms of choice. The results shall show that the precision of the proposed method is statistically equivalent or better than that of the reference method.

X
V1M5 1.5.3
Selectivity (sensitivity) – Verify all responses in at least ten (10) samples using mixed cultures that include the target organism(s) and at varying concentrations (microbial identification testing or equivalent processes may be used). Calculate the number of false positive and false negative results.

X
V1M5 1.6 Demonstration of Capability (DOC) N/A
V1M5 1.6.1 General N/A
V1M5 1.6.1.1
An individual who performs any activity involved with preparation and/or analysis of samples must have constant, close supervision (as defined in the laboratory's training procedure) until a satisfactory initial DOC is completed (see Section 1.6.2).

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.6.1.2 Thereafter, ongoing DOC (Section 1.6.3), must be performed and documented at least every twelve (12) months. X
V1M5 1.6.1.3
In cases where an individual has prepared and/or analyzed samples using a method that has been in use by the laboratory for at least one (1) year prior to applying for accreditation and where there have been no significant changes in instrument type or method, the ongoing DOC shall be acceptable as an initial DOC. The laboratory shall have records on file to demonstrate that an initial DOC is not required.

X
V1M5 1.6.1.4
All demonstrations shall be documented. All data applicable to the demonstration shall be retained and readily available at the laboratory.

X
V1M5 1.6.2 Initial DOC N/A
V1M5 1.6.2 An initial DOC shall be made prior to using any method, X V1M5 1.6.2 An initial DOC shall be made at any time there is a change in instrument type, personnel or method X
V1M5 1.6.2
An initial DOC shall be made any time that a method has not been performed by the laboratory or analyst in a twelve (12) month period.

X
V1M5 1.6.2.1
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee:

N/A
V1M5 1.6.2.1 a) analyst(s) involved in preparation and/or analysis; X V1M5 1.6.2.1 b) matrix; X
V1M5 1.6.2.1 c) organism(s); X
V1M5 1.6.2.1 d) identification of method(s) performed; X V1M5 1.6.2.1 e) identification of laboratory-specific SOP used for analysis, including revision number; X
V1M5 1.6.2.1 f) date(s) of analysis; X
V1M5 1.6.2.1 g) summary of analyses, including information outlined in Section

1.6.2.2.c. X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.6.2.2
If the method or regulation does not specify an initial DOC, the following procedure is acceptable. It is the responsibility of the laboratory to document that other approaches to initial DOC are adequate.

N/A
V1M5 1.6.2.2 a)
The target organism(s) shall be diluted in a volume of sterile, quality system matrix (a sample in which no target organisms or interferences are present at concentrations that will impact the results of a specific method).

X
V1M5 1.6.2.2 a)
When required by method, the diluent shall be sterile buffered water and/or sterile peptone water unless specified by the manufacturer. Prepare at least four (4) aliquots at the concentration specified, or if unspecified, to the countable range for plate methods or working range for most probable number (MPN) type methods.

X
V1M5 1.6.2.2 b) At least four (4) aliquots shall be prepared and analyzed according to the method either concurrently. X
V1M5 1.6.2.2 c)
Using all of the results, convert these results to logarithmic values, then calculate the mean recovery and standard deviation of the log converted results in the appropriate reporting units for each organism of interest. When it is not possible to determine mean and standard deviations, such as for presence/absence, the laboratory shall assess performance against established and documented criteria.

X
V1M5 1.6.2.2 d)
For qualitative tests, acceptable performance in a blind study, either internally or externally generated, may be used to meet this Standard, provided that the study consists of a minimum of a blank, a negative culture, and a positive culture for each target organism.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.6.2.2 e)
Compare the information from c) above to the corresponding acceptance criteria for precision and accuracy in the method (if applicable or in laboratory-generated acceptance criteria (if there are not established mandatory criteria). If all parameters meet the acceptance criteria, the analysis of actual samples may begin. If any one of the parameters does not meet the acceptance criteria, the performance is unacceptable for that parameter.

X
V1M5 1.6.2.2 f)
When one or more of the tested parameters fail at least one of the acceptance criteria, the analyst shall proceed according to i) or ii) below.

N/A
V1M5 1.6.2.2 f) i. Locate and correct the source of the problem and repeat the initial DOC for all parameters of interest beginning with b) above.

X
V1M5 1.6.2.2 f) ii. Repeat the initial DOC for all parameters that failed to meet criteria.

X
V1M5 1.6.2.2 g)
Repeated failure, however, confirms a general problem with the measurement system. If this occurs, locate and correct the source of the problem and repeat the test for all organisms of interest beginning with b) above.

X
V1M5 1.6.3 Ongoing DOC N/A
V1M5 1.6.3.1
The laboratory shall have a documented procedure describing ongoing DOC that includes how the lab will identify data associated with ongoing DOCs.

X
V1M5 1.6.3.1
The analyst(s) shall demonstrate ongoing capability by routinely meeting the quality control requirements of the method, laboratory SOP, client specifications, and/or this Standard.

X
V1M5 1.6.3.1
If the method has not been performed by the analyst in a twelve (12) month period, an initial DOC (Section 1.6.2) shall be performed prior to performing analysis.

X
V1M5 1.6.3.1 It is the responsibility of the laboratory to document that other approaches to ongoing DOC are adequate. X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.6.3.2 This ongoing demonstration may include one of the following , or by performing another initial DOC. N/A
V1M5 1.6.3.2 a)
Analysis of one (1) sample o f clean matrix that is fortified with a known quantity of the target organism, with results meeting the laboratory acceptance criteria for accuracy and, where applicable to the testing technique, also meeting the observational details expected for the presumptive, confirmed and completed phases defined in the method.

X
V1M5 1.6.3.2 b)
Analysis of one (1) positive sample in duplicate for each target organism and test, with results meeting the laboratory acceptance criterion for precision.

X
V1M5 1.6.3.2 c)
Acceptable results for a blind proficiency test sample or sample set, as required by the program, for target organisms in each field of accreditation.

X
V1M5 1.6.3.2 d)
Performance of an alternate adequate procedure for the field of accreditation, the procedure and acceptance criteria being documented in the laboratory’s quality system.

X
V1M5 1.6.3.2 e)
A documented process of reviewing samples QC sample
performed by an analyst, or groups of analysts, relative to the QC requirements of the method, laboratory SOP client specifications, and/or this Standard. The review can be used to identify patterns for individuals or groups of analysts and determine if corrective action or retraining is necessary.

X
V1M5 1.6.3.2 f)
If a) through e) are not technically feasible, then analysis of realworld samples with results within predefined acceptance criteria (as defined by the laboratory or method) shall be performed.

X
V1M5 1.7 Technical Requirements N/A
V1M5 1.7.1 Calibration N/A
V1M5 1.7.1.1
The laboratory shall have documented procedures for calibration, verification, and QC of support equipment including conductivity meters, oxygen meters, pH meters, hygrometers, and other similar measurement instruments.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.1.1 These procedures shall refer to applicable reference methods. X V1M5 1.7.2 For instruments that are continuous monitors, such as in-line specific conductance meters: N/A
V1M5 1.7.V1M5 1.2
a)
The laboratory shall document acceptable calibration verification at least once a month. X
V1M5 1.7.V1M5 1.2
b)
an initial calibration shall be performed if a continuing calibration is unacceptable, or X
V1M5 1.7.V1M5 1.2
b)
when the instrument is being returned to service after having been taken off-line. X
V1M5 1.7.2 Continuing Calibration - Reserved for specific procedures. N/A V1M5 1.7.3 Quality Control N/A
V1M5 1.7.3.1 Quality and Sterility of Standards, Reagents, Materials, and Media N/A V1M5 1.7.3.1
The laboratory shall demonstrate and document that the quality of the reagents and media used is appropriate for the test concerned including, but not limited to, test conditions and incubation times
X
V1M5 1.7.3.1 a) Sterility Checks N/A
V1M5 1.7.3.1 a)
All materials and supplies that are needed to process the sample and are required to be sterile prior to use (whether sterilized in the laboratory or purchased as sterilized) must be checked by the laboratory once per purchased or prepared lot using non-selective growth media as appropriate.

X sterile vessels not checked
V1M5 1.7.3.1 a) Certificates of analysis provided by vendors shall be verified by the laboratory and retained in accordance with V1M2 5.6.4.2.a). X V1M5 1.7.3.1 a) These checks shall include, but are not limited to: N/A V1M5 1.7.3.1 a) i.

The laboratory shall perform a sterility check for each lot of prepared ready to use media and on each batch of media
prepared in the laboratory.

X
V1M5 1.7.3.1 a) i.a For chromo/fluorgenic media: add media to sterile deionized water and incubate at the appropriate temperature and time. X Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.1 a) i.b
For all other media, incubate uninocculated at the appropriate temperature and time. Where media are made as concentrates (e.g., double strength), then the medium shall be diluted to working strength with sterile deionized water before testing.

X
V1M5 1.7.3.1 a) ii.

The laboratory shall perform a sterility check on one (1) funnel per lot of pre-sterilized single use funnels using non-selective growth media.

X
V1M5 1.7.3.1 a) ii.

The laboratory shall perform a sterility check on one (1) funnel per batch of laboratory-sterilized funnels, using non-selective growth media.

X
V1M5 1.7.3.1 a) iii.

The laboratory shall perform a sterility check on at least one (1) container for each lot of purchased, pre-sterilized sample containers with non-selective growth media.

X
V1M5 1.7.3.1 a) iii.

The laboratory shall perform a sterility check on one (1) container/object per sterilization batch sterilized in the laboratory with nonselective growth media.

X
V1M5 1.7.3.1 a) iv.

The laboratory shall perform a sterility check on each batch of dilution water prepared in the laboratory and on each lot of preprepared, ready-to-use dilution water with non-selective growth media. The concentration of the non-selective growth media shall be single strength after the addition of dilution water.

X
V1M5 1.7.3.1 a) v.

The laboratory shall perform a sterility check on at least one (1) filter from each new lot of membrane filters with nonselective growth media.

X
V1M5 1.7.3.1 b) Media N/A
V1M5 1.7.3.1 b) Media – Culture media may be prepared from commercial dehydrated powders or may be purchased ready-to-use. N/A V1M5 1.7.3.1 b) i.

All media shall be tested for performance (e.g., for selectivity, sensitivity, sterility, growth promotion, and growth inhibition).

These tests shall be performed at a minimum with first use.

X
V1M5 1.7.3.1 b) ii. The laboratory shall use all media within the expiration date or shelf life provided by the manufacturer X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.1 b) iii. The laboratory shall use all laboratory-prepared media within the holding time limits specified in the accredited method. X V1M5 1.7.3.1 b) iv.

The laboratory shall have detailed testing criteria information defined in the laboratory’s methods, SOPs, or similar
documentation
X
V1M5 1.7.3.1 c) The laboratory shall use reagents, media and commercial dehydrated powders within the shelf life of the product, X V1M5 1.7.3.1 c) and shall maintain documentation as per Volume1, Module 2 Quality Systems: General Requirements, Section 5.6.4.2 X V1M5 1.7.3.1 d). Reagent Water N/A
V1M5 1.7.3.1 d) i.

The laboratory shall monitor the quality of the reagent water used in the laboratory, which will come into contact with test organisms and is used in preparation of media, solutions, and buffers, for bactericidal and inhibitory substances. This water shall be distilled water, deionized water, or reverse-osmosis-produced water.

X
V1M5 1.7.3.1 d) ii.

The laboratory shall monitor the quality of the water for disinfectant residual, specific conductance, total organic carbon, and heterotrophic bacteria plate count monthly (when in use), when maintenance is performed on the water treatment system, or at startup after a period of disuse longer than one month.

Analysis may be performed by another certified laboratory.

X
V1M5 1.7.3.1 d) iii.

The laboratory shall monitor the quality of the water for metals (Cd, Cr, Cu, Ni, Pb, and Zn) and the Bacteriological Water Quality Test (to determine presence of toxic agents or growth promoting substances) annually. Analysis may be performed by another certified laboratory.

X
V1M5 1.7.3.1 d) iii.

An exception to performing the Bacteriological Water Quality Test shall be given to laboratories that can supply documentation to show that their water source meets the criteria, as specified by the method, for High Quality (Type I) or Medium Quality (Type II) reagent water.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.1 d) iv.

Results of the above analyses shall meet the specifications of the required method. Records of analyses shall be maintained for five (5) years.

X
V1M5 1.7.3.1 d) v.

Reagent water purchased from an outside source and used for the preparations of media, solutions and buffers shall meet the criteria specified in items ii) and iii) above. The laboratory shall have documented records of this information.

X
V1M5 1.7.3.1 d) vi.

Reagent water that has been opened for longer than the testing intervals specified in items i) through iv), or in the accredited method, shall either be re-tested or discarded.

X
V1M5 1.7.3.1 e) Dilution water, however used, includes buffer water and/or peptone water. N/A
V1M5 1.7.3.1 e)
The laboratory shall monitor the quality of the dilution water for sterility, pH and volume once per lot or batch whether purchased or lab prepared.

X
V1M5 1.7.3.1 f).

Documentation for media and reagents prepared in the laboratory shall include date of preparation, preparer’s initials, type, manufacturer, lot number, final pH, expiration date, and the amount of reagents used. Records shall be retained by the laboratory in accordance with Volume 1, Module 2, Section

5.4.6.2. X
V1M5 1.7.3.1 f).

Documentation for media purchased pre-prepared, ready-to-use (including reagent water purchased from outside sources) shall include manufacturer, lot number, type of media received, date of receipt, expiration date of the media, and pH of the media.

Records shall be retained by the laboratory in accordance with Volume 1, Module 2, Section 5.4.6.2.

X
V1M5 1.7.3.2 Method Blanks N/A
V1M5 1.7.3.2
The laboratory shall demonstrate that the filtration equipment and filters, sample containers, media, and reagents have not been contaminated through improper handling or preparation, or environmental exposure.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.2 a)
For filtration technique, the laboratory shall conduct method blanks per the analytical method. At a minimum, the filtration series shall include a beginning and ending blank. The filtration series may include single or multiple filtration units, which have been sterilized prior to beginning the series.

X
V1M5 1.7.3.2 b)
The filtration series is considered ended when more than thirty (30) minutes elapses between successive filtrations. During a filtration series, filter funnels shall be rinsed with three (3) 20-30 ml portions of sterile rinse water after each sample filtration.

X
V1M5 1.7.3.2 b)
In addition, laboratories shall insert a method blank after every ten (10) samples or sanitize filtration units by UV light (254-nm) after sample filtration.

X
V1M5 1.7.3.2 c)
For pour plate technique, method blanks of the medium shall be made by pouring, at a minimum, one (1) uninoculated plate for each lot of pre-prepared, ready-to-use media and for each batch of medium prepared in the laboratory.

X
V1M5 1.7.3.3 Test Variablity/Reproducibility N/A
V1M5 1.7.3.3
For methods that specify counts (i.e. cfu/100mL or MPN/100mL) such as membrane filter, plated media or other methods which specify a quantitative result, duplicate counts shall be performed monthly on one (1) positive sample for each month that the test is performed.

X
V1M5 1.7.3.3
If the laboratory has two (2) or more analysts, each analyst shall count typical results on the same sample. Counts shall be within ten percent (10%) difference to be acceptable.

X No analyst duplicate counts
V1M5 1.7.3.3
In a laboratory with only one (1) microbiology analyst, the same sample shall be counted twice by the analyst, with no more than a five percent (5%) difference between the counts.

X
V1M5 1.7.3.4 Sample Specific Controls (where applicable) N/A V1M5 1.7.3.4 a) Matrix spikes shall be performed per method requirements. X V1M5 1.7.3.4 b) Sample matrix duplicates shall be performed per method requirements. X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.5 Data Reduction N/A
V1M5 1.7.3.5 The calculations, data reduction and statistical interpretations specified by each method shall be identified and followed. X V1M5 1.7.3.6 Selectivity N/A
V1M5 1.7.3.6 a)
All growth and recovery media shall be checked to assure that the target organism(s) respond in an acceptable and predictable manner once per lot or batch.

X
V1M5 1.7.3.6 b)
To ensure that analysis results are accurate, target organism identity shall be verified as specified in the method (e.g., by use of the completed test, or by use of secondary verification tests such as a catalase test, or by the use of a selective medium such as Brilliant Green Lactose Bile Broth (BGLB) or EC or EC + MUG broth.

X
V1M5 1.7.3.6 c)
In order to ensure identity and traceability, reference cultures used for positive and negative controls shall be obtained from a recognized national collection, organization, or manufacturer recognized by the accreditation body.

X
V1M5 1.7.3.6 c)
Microorganisms may be single use preparations or cultures maintained for their intended use by documented procedures that demonstrate the continued purity and viability of the organism.

X
V1M5 1.7.3.6 c) i. Reference cultures may be revived (if freeze-dried) or transferred from slants and sub-cultured once to provide reference stocks. X V1M5 1.7.3.6 c) i. The reference stocks shall be preserved by a technique that maintains the characteristics of the strains. X
V1M5 1.7.3.6 c) i. Reference stocks shall be used to prepare working stocks for routine work. X
V1M5 1.7.3.6 c) i. If reference stocks have been thawed, they shall not be refrozen and re-used. X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.6 c) ii.

Working stocks shall not be sequentially cultured more than five (5) times and shall not be sub-cultured to replace reference stocks.

X
V1M5 1.7.3.6 d) Culture Controls (i.e. working cultures) N/A V1M5 1.7.3.6 d) i. Negative Culture Controls N/A
V1M5 1.7.3.6 d) i. a.

Negative culture controls demonstrate that the medium does not support the growth of non-target organisms or does not exhibit the typical positive reaction of the target organism(s).

N/A
V1M5 1.7.3.6 d) i. b.

Each pre-prepared, ready-to-use lot of selective medium (including chromofluorogenic reagent) and each batch of selective medium prepared in the laboratory shall be analyzed with one or more known negative culture controls (i.e. non-target organisms), as appropriate to the method. This shall be done prior to first use of the medium.

X
V1M5 1.7.3.6 d) ii. Positive Culture Controls N/A
V1M5 1.7.3.6 d) ii. a.

Positive culture controls demonstrate that the medium can support the growth of the target organism(s), and that the medium produces the specified or expected reaction to the target organism(s).

N/A
V1M5 1.7.3.6 d) ii. b.

Each pre-prepared, ready-to-use lot of medium (including chromo/fluorogenic reagent) and each batch of medium prepared in the laboratory shall be tested with at least one (1) or more known pure positive culture controls (i.e. target organism) as appropriate to the method and that produce typical results based on the method. This shall be done prior to first use of the medium.

X
V1M5 1.7.3.7 Constant and Consistent Test Conditions N/A V1M5 1.7.3.7 a) Laboratory Facilities N/A
V1M5 1.7.3.7 a) Floors and work surfaces shall be non-absorbent and easy to clean and disinfect. X
V1M5 1.7.3.7 a) Work surfaces shall be adequately sealed. X Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.7 a) Laboratories shall provide sufficient storage space, and shall be clean and free from dust accumulation. X
V1M5 1.7.3.7 b) i Temperature Measuring Devices N/A
V1M5 1.7.3.7 b) i
The laboratory shall use temperature measuring devices such as liquid-in-glass thermometers, thermocouples, or platinum resistance thermometers to assess and document equipment temperatures.

X
V1M5 1.7.3.7 b) i The temperature measuring devices shall be appropriate quality to meet specification(s) in the method. X
V1M5 1.7.3.7 b) i
The graduation and range of the temperature measuring devices shall be appropriate for the required accuracy of the
measurement.

X
V1M5 1.7.3.7 b) i Temperature measuring devices shall be verified to national or international standards for temperature. X
V1M5 1.7.3.7 b) i
Verification shall be performed at least annually (see TNI Volume 1, Module 2, Section 5.5.13.1). This verification may be accomplished by a single point provided that it represents the method mandated temperature and use conditions.

X
V1M5 1.7.3.7 b) ii Sterilization Equipment N/A
V1M5 1.7.3.7 b) ii. a. Autoclaves N/A
V1M5 1.7.3.7 b) ii. a.
1 The laboratory shall evaluate the performance of each autoclave initially by establishing its functional properties and performance, for example, heat distribution characteristics with respect to typical uses. Autoclaves shall meet specified temperature tolerances.

Pressure cookers shall not be used for sterilization of growth media.

X
V1M5 1.7.3.7 b) ii. a.
2 The laboratory shall demonstrate proper sterilization temperature by use of a continuous temperature recording device or by use of a maximum registering thermometer with every cycle.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.7 b) ii. a. 2
The laboratory shall at least once during each month that the autoclave is used, demonstrate the effective sterilization through the use of appropriate biological indicators. The selected biological indicator shall be effective at the sterilization temperature and time needed to sterilize lactose-based media.

X
V1M5 1.7.3.7 b) ii. a. 2
The laboratory shall use temperature sensitive tape with the contents of each autoclave run to indicate that the autoclave contents have been processed.

X
V1M5 1.7.3.7 b) ii. a. 3The laboratory shall maintain records of autoclave operations for every cycle.

X
V1M5 1.7.3.7 b) ii. a. 3
Records shall include: date, contents, maximum temperature reached, pressure, time in sterilization mode, total run time (may be recorded as time in and time out), and analyst’s initials.

X
V1M5 1.7.3.7 b) ii. a. 4
Autoclave maintenance, internally or by service contract, shall be performed annually, and shall include a pressure check and verification of temperature device.

X
V1M5 1.7.3.7 b) ii. a. 4Records of the maintenance shall be maintained in equipment logs.

X
V1M5 1.7.3.7 b) ii. a. 4When it has been determined that the autoclave has no leaks, pressure checks can be documented using the formula PV = nRT. N/A V1M5 1.7.3.7 b) ii. a. 5
The laboratory shall check the autoclave mechanical timing device quarterly against a stopwatch and document the actual time elapsed.

X
V1M5 1.7.3.7 b) ii. b. Ovens N/A
V1M5 1.7.3.7 b) ii. b.

The laboratory shall check ovens used for sterilization for sterilization effectiveness monthly with appropriate biological indicators.

X
V1M5 1.7.3.7 b) ii. b. The laboratory shall maintain records for each cycle that include date, cycle time, temperature, contents, and analyst’s initials.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.7 b) ii. b.

The laboratory shall use temperature sensitive tape with the contents of each run to indicate that the contents have been processed.

X
V1M5 1.7.3.7 b) iii. Volumetric Equipment N/A
V1M5 1.7.3.7 b) iii. The laboratory shall verify equipment used for measuring volume as follows: N/A
V1M5 1.7.3.7 b) iii. a
Equipment with movable parts, such as automatic dispensers, dispensers/ diluters, and mechanical hand pipettes, shall be verified for accuracy quarterly.

X
V1M5 1.7.3.7 b) iii. b
Equipment, such as filter funnels, bottles, non-Class A glassware, and other containers with volumetric markings (including sample analysis vessels), shall be verified once per lot prior to first use.

X bottles not checked for
volume
V1M5 1.7.3.7 b) iii. c
The volume of the disposable volumetric equipment, such as sample bottles and disposable pipettes, shall be checked once per lot.

X
V1M5 1.7.3.7 b) iii. d
Verification of volume shall be considered acceptable if the accuracy is within 2.5% of expected volume. This verification can be volumetric as compared to Class A or gravimetric.

X
V1M5 1.7.3.7 b) iv. UV Instruments N/A
V1M5 1.7.3.7 b) iv.

The laboratory shall evaluate UV instruments used for sanitization quarterly for effectiveness with an appropriate UV light meter, by plate count, agar spread plates, or other methods providing equivalent results such as UV-cide strips.

X
V1M5 1.7.3.7 b) iv.

Replace bulbs if output is less than 70% of original for light tests or if count reduction is less than 99% for a plate containing 200 to 300 organisms.

X
V1M5 1.7.3.7 b) v. Incubators, Water Baths N/A
V1M5 1.7.3.7 b) v.a
The laboratory shall establish the uniformity of temperature distribution and equilibrium in incubators and water baths prior to first use after installation or service.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.7 b) v.a
The equilibrium check shall include time requried after test sample addition to re-establish equilibrium conditions under full capacity load appropriate for the intended use.

X
V1M5 1.7.3.7 b) v.b
During periods when samples are under test, the laboratory shall have a system in place to monitor and document the temperature of incubators and water baths twice daily, at least four hours apart.

X
V1M5 1.7.3.7 b) v.b "Under test' is defined as the time period that the sample is in the incubation phase of the method. N/A
V1M5 1.7.3.7 b) v.b
Data loggers, continuous temperature monitoring devices, or other temperature monioting equipment can be used as long as they can be calibrated in accordance with V1M2, Section 5.5.13.1 for Support Equipment.

X
V1M5 1.7.3.7 b) v.b Records shall be maintained in accordance with V1M2 Section

4.13: Records Maintenance. X
V1M5 1.7.3.7 b) v.b N NOTE: There is no intent to take the temperature of incubation units during periods when there are no samples under test N/A V1M5 1.7.3.7 b) vi. Labware (Glassware and Plasticware) N/A V1M5 1.7.3.7 b) vi.a The laboratory shall have a documented procedure for washing labware, if applicable. X
V1M5 1.7.3.7 b) vi.a Detergents designed for laboratory use shall be used. X V1M5 1.7.3.7 b) vi.b
Glassware shall be made of borosilicate or other non-corrosive material, free of chips and cracks, and shall have readable measurement marks.

X
V1M5 1.7.3.7 b) vi.c
Labware that is washed and reused shall be tested for possible presence of residues that may inhibit or promote growth of microorganisms by performing the Inhibitory Residue Test initially and each time the laboratory changes the detergent formulation or washing procedures.

X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.3.7 b) vi.d
Washed labware shall be tested at least once daily, each day of washing, for possible acid or alkaline residue by testing at least one (1) piece of labware with a suitable pH indicator such as bromothymol blue.

X
V1M5 1.7.3.7 b) vi.d Records of tests shall be maintained. X V1M5 1.7.4 Data Acceptance/Rejection Criteria N/A
V1M5 1.7.4 Method criteria and evaluation methods shall be used. X V1M5 1.7.5 Sample Handling N/A
V1M5 1.7.5 Receipt of samples must comply with V1M2 Sections 5.8.6 and

5.8.7 in addition to the Standard requirements below. N/A V1M5 1.7.5.1
Samples that require thermal preservation shall be considered acceptable if the arrival temperature of a representative sample container meets the method or mandated temperature
requirement.

X
V1M5 1.7.5.1
Samples that are delivered to the laboratory on the same day they are collected may not meet the requirements of Section

1.7.5 or the method or the regulatory requirements. In these cases, the samples may be considered acceptable if the samples were received on ice with evdience that the cooling process has begun.

X
V1M5 1.7.5.1 N NOTE: The intent is for the samples to be preserved immediately and analyzed as soon as possible. N/A
V1M5 1.7.5.2
Microbiological samples from known chlorinated sources (such as wastewater effluent), unknown sources where disinfectant (e.g. chlorine) usage is suspected (such a new client or a new source) and all potable water sources (including source water) shall be checked for absence of disinfectant residual in the laboratory unless all of the following conditions are met:

X
V1M5 1.7.5. a)
The laboratory can show that the received sample containers are from its laboratory or have been appropriately tested and documented;
X
Citation
Volume 1 Module 5
(V1M5 - Micro)
Does the laboratory comply with this section? Yes No N/A Comments V1M5 1.7.5. b)
Sufficient sodium thiosulfate was in each container before sample collection to neutralize at minimum 5 mg/L of chlorine for drinking water and 15 mg/L of chlorine for wastewater samples;
X
V1M5 1.7.5. c)
One container from each batch of laboratory-prepared containers or lot of purchased ready-to-use containers is checked to ensure efficacy of the sodium thiosulfate to 5 mg/L chlorine or 15 mg/L chlorine as appropriate and the check is documented;
X
V1M5 1.7.5.d) Disinfectant residual is checked in the field and actual concentration is documented with sample submission. X
TNI 2016 Standard Checklist: Volume 1 Module 1 - Proficiency Testing Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 1 PROFICIENCY TESTING N/A
V1M1 1 INTRODUCTION, SCOPE, AND APPLICABILITY N/A
V1M1 1.1 Introduction N/A
V1M1 1.1 Volume 1, Module 1 provides the requirements for laboratory participation in the TNI Proficiency Testing (PT) program. N/A V1M1 1.2 Scope N/A
V1M1 1.2
The purpose of the TNI PT program is to provide a means for an Accreditation Body (AB) to evaluate a laboratory’s performance, under specified conditions relative to a given set of criteria in a specific area of testing, through analysis of PT samples provided by an external source.

N/A
V1M1 1.3 Applicability N/A
V1M1 1.3.1
Volume 1, Module 1 is applicable to any laboratory attempting to gain or maintain accreditation from a Primary AB that uses this Standard as the basis for accreditation regardless of the number of personnel working in the laboratory or the scope of testing performed by the laboratory.

N/A
V1M1 1.3.2
This Standard applies only to fields of accreditation (FOA) that are also designated as fields of proficiency testing (FoPT) by the TNI Proficiency Testing Program Executive Committee (PTPEC).

N/A
2 NORMATIVE REFERENCES N/A
V1M1 2 Not Applicable N/A
V1M1 3 TERMS AND DEFINITIONS N/A
V1M1 3
For the purpose of this Standard, the relevant terms and definitions conform to ISO/IEC 17011:200V1M1 4 and ISO/IEC 17025:2005. Additional relevant terms are defined below.

N/A
V1M1 4 REQUIREMENTS FOR ACCREDITATION N/A
V1M1 4.1 General Requirements N/A
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 4.1.1
TNI publishes lists of FoPTs on the TNI website for which PT studies are required, called TNI FoPT Tables. These FoPT tables may be updated, as needed, by publishing revised FoPT tables on the TNI website.

N/A
V1M1 4.1.2
The laboratory shall participate in PT studies for each field of accreditation where corresponding FoPTs exist in the TNI FoPT tables and for which the laboratory seeks to obtain or maintain accreditation.

X
V1M1 4.1.3
The laboratory shall obtain scheduled PT studies or supplemental studies for the individual fields of proficiency testing from a PT Provider accredited to Volume 3 of this Standard by a TNIapproved PTPA.

X
V1M1 4.1.4
The laboratory shall analyze unique, single-blind, singleconcentration PT samples, when required as stated in the TNI FoPT tables described in Section 4.1.1, to determine compliance for each field of accreditation for which the laboratory seeks to obtain or maintain accreditation.

X
V1M1 4.1.4 N
NOTE: PT results are required by Federal Regulations, 40 CFR 141, per test method, rather than technology for potable water PTs.

N/A
V1M1 4.1.5 a)
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not send a PT study, or a portion of a PT study, in which it is participating, to another laboratory for the analysis of a field of accreditation for which it seeks accreditation or is accredited.

X
V1M1 4.1.5 b)
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not knowingly receive and analyze any PT sample or portion of a PT sample from another laboratory for which the results of the PT sample are intended for use for initial or continued accreditation of that laboratory.

X
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 4.1.5 c)
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not communicate with any individual at another laboratory, including other laboratories under common ownership, concerning the analysis of the PT sample.

X
V1M1 4.1.5 d)
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not attempt to obtain the assigned value of any portion of the PT study from the PT Provider.

X
V1M1 4.1.6 Participation in any of the above activities listed in 4.1.5 is cause for revocation of accreditation. N/A
V1M1 4.1.7
When a regulatory program has additional PT requirements for FoPTs not covered by this standard, then the laboratory shall follow those requirements.

X
V1M1 4.2 Sample Handling, Preparation and Analysis Requirements N/A V1M1 4.2.1 The laboratory shall handle and prepare the PT study samples in accordance with the instructions provided by the PT Provider. X V1M1 4.2.2
PT samples shall be analyzed in accordance with the laboratory’s routine standard operating procedures (SOPs) using the same quality control (QC) acceptance criteria and staff as used for the analysis of routine environmental samples.

X
V1M1 4.2.3
The laboratory shall evaluate the analytical result for each chemistry and radiochemistry field of accreditation to the PTRL as established by the TNI FoPT Tables.

X
V1M1 4.2.4
For chemistry analyses, if the laboratory’s Limit of Quantitation (LOQ) is below the PTRL, they may evaluate results to their normal LOQ.

N/A
V1M1 4.2.5 a)
For chemistry PT results where the concentrations are below the calibration range established by the initial calibration curve, the laboratory may re-scale its initial calibration curve to bracket the concentration of the PT sample result
N/A
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 4.2.5 b)
For chemistry PT results where the concentrations are below the calibration range established by the initial calibration curve, the laboratory may report the results, as measured with the initial calibration curve, without qualification to the PT Provider, provided the laboratory adheres to the requirements of section V1M1 4.3.7.

N/A
V1M1 4.3 Reporting Requirements N/A
V1M1 4.3.1
The laboratory shall report PT study results to the PT Provider on or before the closing date of the study using the reporting format offered by the PT Provider.

X
V1M1 4.3.2
The laboratory shall, on or before the closing date of the study, direct the PT Provider to report the PT study performance results directly to the AB(s) designated by the laboratory.

X
V1M1 4.3.2
For initial accreditation(s) the laboratory shall direct the PT Provider to provide all relevant PT study results to the AB to support their accreditation application.

X
V1M1 4.3.3
The laboratory shall report results in such a way that there is a specific match between the analytical result for the FoPT and the corresponding Field of Accreditation for which the PT sample was analyzed.

X
V1M1 4.3.4
Except for drinking water analytes referenced in 40 CFR 141, a laboratory may choose to analyze and report a single method to represent a technology in a single PT study for a particular analyte.

N/A
V1M1 4.3.4
If the laboratory analyzes and reports PT studies by “technology,” the score obtained for the reported method will be applied to all methods in that technology for which the laboratory seeks to obtain or maintain accreditation in that matrix.

N/A
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 4.3.4 N
NOTE: If a laboratory reports PT results for multiple methods using the same analytical technology, an evaluation of not acceptable for one method will be applied to all methods reported with that technology.

N/A
V1M1 4.3.5
The laboratory shall report chemistry PT study results to the PTRL as established by the TNI FoPT Tables, or if the laboratory LOQ is below the PTRL, the laboratory may report results down to their normal LOQ, and as specified in section 4.2.4.

X
V1M1 4.3.6
Radiochemistry results shall be reported as measured, including zero, negative, and positive results, and shall not be censored or reported as "less than" values.

X
V1M1 4.3.6 All radiochemistry PT study results shall be reported in association with the measurement uncertainty, as appropriate to the program. X V1M1 4.3.7 a)
The laboratory shall evaluate and report each chemistry FoPT result to the PT Provider as follows: a) If the analytical result is a numeric value above or equal to the PTRL, the lab shall report the value. If the PTRL is less than the laboratory’s LOQ, the laboratory shall report the result without the qualification of result required in Volume 1, Module 4 of this Standard.

X
V1M1 4.3.7 b)
The laboratory shall evaluate and report each chemistry FoPT result to the PT Provider as follows: b) If the analytical result is a numeric value below the PTRL, the laboratory shall report one of the following; i. < PTRL or, ii. the obtained analytical result, if the result is between the LOQ and the PTRL or, iii. < LOQ, if the analytical result is below the LOQ and the PTRL.

X
V1M1 4.3.7 c)
The laboratory shall evaluate and report each chemistry FoPT result to the PT Provider as follows: c) If the analytical result is a non-detect the laboratory shall report one of the following; i. <PTRL or, ii. < LOQ
X
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 4.3.7 N
NOTE: In the case where the laboratory LOQ is greater than the PTRL: If the laboratory chooses to report a value of < LOQ and the analyte is present above the PTRL, the result will be scored as “Not Acceptable” by the PT provider.

N/A
V1M1 4.3.8 The PTRL value shall not be adjusted for sample amount used or percent moisture. X
V1M1 4.4 Record Retention N/A
V1M1 4.V1M1 4.1
The laboratory shall retain all records necessary to facilitate reconstruction of the preparation, processing, and reporting of analytical results for PT samples for a minimum of five years.

X
V1M1 4.4.1
The laboratory shall make all records necessary to facilitate reconstruction of the preparation, processing, and reporting of analytical results for PT samples available for review upon request by the Primary AB.

X
V1M1 5 PT STUDY FREQUENCY REQUIREMENTS FOR ACCREDITATION N/A V1M1 5.1 Initial Accreditation N/A
V1M1 5.1.1 Chemical Testing, Radiochemical Testing, Asbestos and Microbiology N/A
V1M1 5.1.1 a)
The laboratory shall achieve a history of two (2) successful (acceptable scores) PT studies out of the most recent three (3) attempts for each field of accreditation specified in section V1M1

4.1.1 for which the laboratory seeks accreditation.

X
V1M1 5.1.1 a) N NOTE: If the laboratory has two consecutive acceptable PT scores, a third study is not needed. N/A
V1M1 5.1.1 b)
The two (2) PT studies identified in section 5.1.1 a) must be performed no more than eighteen (18) months prior to obtaining initial accreditation from an AB.

X
V1M1 5.1.1 c) The opening date of the second study must be at least seven (7) calendar days after the closing date of the first study. X Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 5.1.1 d)
The closing date of the most recent successful PT study for a FoPT must be no more than six (6) months prior to the application for initial accreditation and the laboratory shall continue to participate in PT studies at least semi-annually (no more than seven (7) months apart between consecutive attempts) from that point on.

X
V1M1 5.1.2
For Whole Effluent Toxicity (WET) testing, the laboratory shall demonstrate to the primary AB that it has received an acceptable evaluation for at least one (1) PT study to obtain initial accreditation.

X
V1M1 5.1.2
The study closing date of the most recent successful PT study shall be no more than twelve (12) months prior to obtaining initial accreditation from an AB, and the laboratory shall continue to participate in PT studies annually from that point on.

X
V1M1 5.1 N
NOTE: “Acceptable” PT study scores from a PT Provider do not automatically result in a successful evaluation of a PT study by an AB. For example, failure to report an analytical method or reporting of an incorrect method, failure to provide the PT Provider with a release of results to the AB before the close of the study, failure to report results to the PT Provider before the closing date, failure to handle PT study samples in the same manner as routine
environmental samples, etc. may be cause for an unsuccessful evaluation by an AB.

N/A
V1M1 5.2 Continued Accreditation N/A
V1M1 5.2.1 Chemical Testing, Radiochemical Testing, Asbestos and Microbiology N/A
V1M1 5.2.1.1
The laboratory shall maintain a history of two (2) successful (acceptable scores) PT studies out of the most recent three (3) attempts for each field of accreditation specified in Section 4.1.1 for which the laboratory holds accreditation.

X
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 5.2.1.1
Failure to maintain a history of two (2) successful (acceptable scores) PT studies out of the most recent three (3) attempts for each field of accreditation specified in Section 4.1.1 for which the laboratory holds accreditation may result in suspension of the affected field of accreditation.

N/A
V1M1 5.2.1.1
The laboratory’s accreditation for a field of accreditation may be revoked for failure of three (3) consecutive PT studies, either by failure to participate in the required PT study or due to failure to obtain acceptable results.

N/A
V1M1 5.2.1.2 a)
The laboratory shall analyze and report a PT study at least twice per year for each accreditation FoPT for which it seeks to maintain accreditation in accordance with the following criteria: a) The closing dates of subsequent PT study samples for a particular accreditation FoPT shall be no more than seven (7) months apart.

X
V1M1 5.2.1.2 b)
The laboratory shall analyze and report a PT study at least twice per year for each accreditation FoPT for which it seeks to maintain accreditation in accordance with the following criteria: b) The opening date of PT study samples for a particular field of accreditation must be at least seven (7) calendar days after the closing date of a PT study for the same field of accreditation.

X
V1M1 5.2.1.2 c)
A laboratory that analyzes and reports PT study results with an opening date of subsequent PT studies for the same field of accreditation that are closer than seven (7) days from the closing date of the previous PT study are invalid for the purposes of compliance with this Standard and are not counted toward the laboratory’s PT history of the most recent three (3) attempts.

N/A
V1M1 5.2.2
For Whole Effluent Toxicity Testing: To maintain accreditation the laboratory shall participate in one (1) WET PT study per calendar year for each accreditation FoPT that correspond to the fields of accreditation for which the laboratory is accredited.

X
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 5.2.2 a) This requirement can be met by annual participation in the EPA DMRQA studies for WET. N/A
V1M1 5.2.2 b)
If the laboratory is not participating in an EPA DMRQA study for WET, the closing dates of subsequent PT study samples for WET testing PT studies must be no more than fourteen (14) months apart.

X
V1M1 5.2.3
A laboratory that fails to analyze and report PT studies for a particular field of accreditation with the frequency specified in Sections 5.2.1 or 5.2.2 for which it seeks to maintain accreditation is charged with a failed PT study.

N/A
V1M1 5.2 N1
NOTE 1: A laboratory may withdraw from a PT study, but
withdrawal from a PT study does not exempt the laboratory from analyzing and reporting a PT study as specified in Sections 5.2.1 and 5.2.2.

N/A
V1M1 5.2 N2
NOTE 2: “Acceptable” PT study scores from a PT Provider do not automatically result in a successful evaluation of a PT study by an AB. For example, failure to report an analytical method or reporting of an incorrect method, failure to provide the PT Provider with a release of results to the AB before the close of the study, failure to report results to the PT Provider before the closing date, failure to handle PT study samples in the same manner as routine
environmental samples, etc. may be cause for an unsuccessful evaluation by an AB.

N/A
V1M1 6 REQUIREMENTS FOR CORRECTIVE ACTION N/A
V1M1 6.1
A laboratory that fails to successfully analyze a PT study for a particular FOA shall determine the root cause of the failure and take corrective action.

X
V1M1 6.2 The laboratory shall document the root cause investigation and subsequent corrective action. X
V1M1 6.2 N NOTE: The requirements for corrective action are described in Volume 1, Module 2 of this Standard. N/A
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 6.3
The laboratory shall provide the root cause investigation and corrective action documentation to the Primary AB within thirty (30) calendar days of a request from the AB.

X
V1M1 6.4
Failure to submit documentation of the root cause investigation or corrective action records, or both, to the AB within thirty (30) calendar days of the request from the primary AB is due cause for suspension of accreditation for a particular FOA.

N/A
V1M1 6.5 a) Documentation for WET corrective actions shall include a copy of the raw data used for the study; X
V1M1 6.5 b)
Documentation for WET corrective actions shall include a copy of the current Standard Reference Toxicant (SRT) control chart relevant to the PT study.

X
V1M1 7 REQUIREMENTS FOR COMPLAINT RESOLUTION N/A
V1M1 7.1
The laboratory shall submit questions about PT samples or performance evaluations made by the PT Provider to the PT Provider.

X
V1M1 7.1
If the PT Provider is not able or is unwilling to resolve the question to the satisfaction of the laboratory, the laboratory shall refer those questions to the PT Provider’s PTPA
X
V1M1 7.2 The laboratory shall submit questions to its AB in regards to the AB’s PT evaluation, if necessary. X
V1M1 8 REQUIREMENTS FOR REINSTATEMENT OF ACCREDITATION

AFTER SUSPENSION OR REVOCATION N/A
V1M1 8.1
A laboratory seeking to have its accreditation reinstated for an FoPT after suspension shall meet the requirements for continued accreditation as described in Section 5.2 of this module X
V1M1 8.2
A laboratory seeking to have its accreditation reinstated for an FoPT after revocation shall meet the requirements for initial accreditation as described in Section 5.1 of this module X
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments V1M1 8.3
A laboratory seeking to have its accreditation reinstated for an FoPT after suspension due to not supplying a requested corrective action report shall meet the requirements for continued accreditation as described in Section 5.2 of this module.

X
Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments Citation
Volume 1 Module 1
(V1M1 - PT)
Does the laboratory comply with this section? Yes No N/A Comments This document for management system review only. May not be used for any other purpose without written permission.

Quality Manual
Appendix B
Laboratory Organization Chart
I I
I President II Quality
Manager
I I
Controller Sample Field Organics
Control Services Section
Manager Manager Manager
I
I I I
Couriers Sample Field Organics
Control Services Personnel
Personnel Personnel
Fig. 1
Ukiah Organizational Chart
Property of Alpha Analytical Laboratories, Inc.

Appendix B - Rev 1. 00
Effective: 12/01/2020
Page App B-1 of App 8-1
I
Inorganics Wet Chemistry
Section Microbiology
Manager Toxicity
Section Manager
I I
Inorganics Wet Chemistry
Personnel Microbiology
Toxicity
Personnel