ATT (8) - CNIC M-5090.1_Ch4_LaboratoryAccreditation.pdf

CNIC M-5090.1

29 Jun 2018

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CHAPTER 4

LABORATORIES

1. Applicability. This chapter applies to all laboratories analyzing drinking water samples for the Navy’s overseas drinking water (ODW) systems, regardless of the size or complexity of the laboratory. The requirements in this document do not obviate compliance with existing laboratory quality assurance/quality control (QA/QC) requirements as defined in host-nation Final Governing Standards (FGS), references (c) and (h), as applicable or more stringent contract specifications.

2. Laboratory Accreditation and Selection. All laboratories analyzing drinking water samples must either be U.S. Army Public Health Center (PHC) laboratories (paragraph 4c of this chapter), third party accredited (paragraphs 4d and 4e of this chapter) or approved by the Water Quality Oversight Council (WQOC) Laboratory Authority (Appendix J). The WQOC Chair will validate all laboratories used for conducting analysis of drinking water samples.

a. Overseas installations will first attempt to use U.S. Army PHC laboratories.

b. If use of U.S. Army PHC laboratories is not a viable option, then installations will use third party accredited laboratories in one of the categories listed below:

(1) Laboratories accredited to ISO/IEC 17025 by International Laboratory Accreditation Cooperation (ILAC) Signatories.

(2) Laboratories in the United States accredited by state Safe Drinking Water Act (SDWA) laboratory certification programs.

c. When third party accredited laboratories cannot be used or are not available, installations will have their local or on-site compliance laboratories approved for use by the WQOC Laboratory Authority. See Appendix I for assistance with choosing an appropriate ODW laboratory. All laboratories that choose to go through the ODW Laboratory Approval Process (Appendix J) instead of pursuing accepted third party accreditation credentials will adhere to the requirements listed below:

(1) Use U.S. Environmental Protection Agency (EPA) or WQOC approved methods.

(2) Maintain staff with qualified personnel.

(3) Maintain a quality management system.

(4) Analyze proficiency testing (PT) samples (at least annually) for all parameters within the scope of their testing.

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(5) Undergo a triennial on-site assessment by the WQOC Laboratory Authority.

(6) Participate in data calls as requested.

3. Enforcement Structure and Responsibilities

a. WQOC Laboratory Authority. The WQOC Laboratory Authority is responsible for developing and implementing the approval program for laboratories that analyze ODW samples.

These responsibilities include the actions specified below:

(1) Validate that overseas laboratory QA/QC requirements are equivalent for more stringent than, U.S. requirements and comply with the drinking water quality testing requirements of reference (c).

(2) Ensure, at a minimum, monthly reporting and communications to the WQOC Chair regarding overseas laboratory implementation.

(3) Define criteria for overseas laboratories to meet and establish laboratory QA/QC policies and guidance.

(4) Evaluate and review laboratory reports prepared at installations, PT results and any associated corrective actions submitted by approved laboratories. Monitor updates to PT protocols and disseminate updated PT requirements as appropriate.

(5) Provide technical support to the WQOC on water quality sampling and testing issues.

(6) Serve as technical expert to the WQOC on drinking water laboratory QA/QC process matters.

(7) Manage the ODW Laboratory Approval Process.

(8) Maintain a current inventory of all validated laboratories (i.e., U.S. Army PHC, third party accredited laboratories and WQOC approved laboratories), as well as their capabilities for sample analysis.

(9) Propose and issue laboratory-related updates to Commander, Navy Installations Command (CNIC) instructions.

(10) Respond to questions and comments on overseas laboratory QA/QC policy and develop written guidance as needed.

(11) Conduct triennial on-site assessment of overseas laboratories approved through the WQOC Laboratory Authority Approval Process (see Appendix J) for chemistry, microbiology, 4-3 radiochemistry and parasitology. This requirement does not apply to the U.S. Army PHC or validated third party accredited laboratories.

(12) Review international testing procedures to ensure they are equivalent for more stringent than, EPA-approved methods.

(13) Encourage Regions and installations to observe on-site assessments of their own laboratories as on-the-job training.

(14) Provide technical support on sampling for drinking water compliance samples.

b. Region Water Quality Board. The Region Water Quality Board (RWQB), with assistance from the WQOC Laboratory Authority, is responsible for working with installations to ensure that all laboratories meet the requirements of this chapter and notifying the WQOC Laboratory Authority of any issues that may arise. RWQB responsibilities include the actions specified below:

(1) Coordinate with installations and U.S. Army PHC for drinking water sampling and analysis work when practical.

(2) Assist installation laboratories with maintaining compliance with this chapter.

(3) Collaborate with installations to determine laboratory contracting needs, appropriate scope, parameters and template language for contracts and assist with contract award and administration to ensure laboratory contracts meet the requirements contained in this chapter.

(4) Assist with data calls and provide input to assist the WQOC.

(5) Participate in assessment of installation laboratories and other overseas laboratories as necessary.

(6) Communicate issues with sample collection, sample processing, data validation, failing PT samples or other issues with contracted laboratories to the WQOC Laboratory Authority.

c. Installation Water Quality Board. The Installation Water Quality Board (IWQB) is responsible for working with installations and notifying the RWQB of any issues that may arise.

IWQB responsibilities include the actions specified below:

(1) When a Region-wide laboratory contract is not in place, work with the RWQB in developing contracts with U.S. Army PHC, other accredited laboratories or laboratories approved by the WQOC Laboratory Authority and validated by the WQOC Chair.

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(2) Communicate issues with sample collection, sample processing, data validation, failing PT samples or other issues with contracted laboratories to the RWQB.

(3) Ensure that installation laboratories comply with this chapter and reference (c) through evaluation during internal environmental management system and environmental quality assurance audits.

(4) Assist with data calls and inform the RWQB of changes to the inventory of approved laboratories.

4. Use of U.S. Army PHC or Third Party Accredited Laboratories

a. Requirements. U.S. Army PHC and third party accredited laboratories listed in this section are NOT subject to the WQOC ODW Laboratory Approval Process in Appendix J.

However, each IWQB is responsible for ensuring third party accredited laboratories are meeting the requirements listed below:

(1) Submitting accreditation credentials to the WQOC Laboratory Authority for acceptance by the WQOC Chair.

(2) Responding to installation, Region or WQOC Laboratory Authority requests for accreditation documentation.

(3) Reporting any failures of their accreditation-required PT samples to the WQOC Laboratory Authority.

(4) Participating in WQOC Laboratory Authority assessments of the accredited laboratories and observation of on-site assessments by the accrediting authority if deemed necessary.

(5) Using the methods specified in chapter 2. The EPA Office of Water provides a list of all the analysis methods, which is available at www.epa.gov/dwanalyticalmethods. Use of equivalent methods will be evaluated by the WQOC Laboratory Authority on a case-by-case basis upon request from the RWQB. RWQB’s wishing to have equivalent methods from a laboratory approved should submit the methods in English to the WQOC Laboratory Authority for review.

(6) Ensuring that sampling personnel are appropriately trained as defined in the respective quality system.

b. Revocation of Validation Status. In addition to the requirements for third party accredited laboratories listed above in paragraphs 4a(1) through 4a(6) of this chapter, both U.S.

http://www.epa.gov/dwanalyticalmethods

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Army PHC and third party accredited laboratories can have their validation status revoked for any of the reasons listed below:

(1) Fail to maintain third party accreditation status.

(2) Fail to satisfy that the laboratory is maintaining the required standard of quality, based upon an on-site assessment.

(3) Fail to report compliance data to the ODW system in a timely manner, thereby preventing compliance with regulations and endangering public health. Data that indicates the potential to exceed a Maximum Contaminant Level (MCL), will be reported within five business days to allow preparation of mandated public notifications.

(4) Falsify data or engage in other deceptive practices (e.g., reporting PT data from another laboratory as its own).

(5) Fail to use the analytical methodology specified in chapter 2 or a WQOC-approved equivalent.

(6) Fail to analyze a PT sample for a particular contaminant within the acceptance limits specified per the accreditation authority’s requirements.

(7) Fail to verify that the laboratory has corrected deviations identified during an on-site assessment.

(8) Refuse to participate in an on-site assessment.

(9) Fail to adhere to contract or agreement performance measures.

c. U.S. Army Public Health Center. Overseas installations must first attempt to use U.S.

Army PHC laboratories if available. U.S. Army PHC has laboratories in the United States (Aberdeen, MD), Europe (Germany) and the Pacific (Japan). All U.S. Army PHC laboratories are accredited by the American Association for Laboratory Accreditation and participate in drinking water PT programs requiring validation of certified methods for analysis. However, installations selecting this option should confirm that the U.S. Army PHC laboratories meet host nation approval requirements if using them for additional sampling required by host nation FGS.

In addition to ensuring that the U.S. Army PHC laboratories can meet host nation approval requirements, installations need to ensure that use of the U.S. Army PHC laboratories is logistically possible (e.g., shipping availability and acceptable holding times and temperatures).

d. Overseas Laboratories. For instances when the U.S. Army PHC cannot be selected, contracted off-site laboratories must comply with reference (c) and be accredited in the relevant analytical methods referenced in chapter 2 of this manual, by accreditation bodies that are

4-6 signatories to the ILAC Mutual Recognition Arrangement. (A list of signatories is available at http://ilac.org/ilac-mra-and-signatories). Additional information on DoD policies for contracting with environmental laboratories can be found in reference (u).

e. Contracted Stateside Laboratories. The WQOC Laboratory Authority will allow overseas installations to use stateside laboratories certified by state SDWA laboratory certification programs. (This is a separate approval process from the one described in Appendix J for non-accredited laboratories.) Applications from installations requesting this option will be reviewed and approved on a case-by-case basis with consideration of the implications regarding holding times, security, cost and logistics. Split samples will be sent to local laboratories when required by host nations. To obtain approval, the laboratory must provide evidence of the stateside laboratory certification to the WQOC Laboratory Authority.

5. Installation Bench Laboratories. Installation laboratories meeting the definition of “Bench Laboratory” must comply with reference (c), complete annual PT samples for their target analytes and report the results to the WQOC Laboratory Authority. Bench Laboratories must also undergo annual assessments by the RWQB and be reviewed during Sanitary Surveys by the WQOC. However, Bench Laboratories do not have to be approved by the WQOC Laboratory Authority or validated by the WQOC Chair. A laboratory performing compliance sampling does not meet the definition of “Bench Laboratory” and would instead be classified as being an “Installation Compliance Laboratory” which would require compliance with the requirements of paragraph 4c of this chapter or Appendix J.

6. Records Management. The WQOC Laboratory Authority ensures that records for the ODW Laboratory Policy are uploaded to the Navy ODW Data Repository (see chapter 12). Records include a list of WQOC Chair-validated laboratories, on-site laboratory assessments and the annual report. Additionally, IWQBs should upload checklists, corrective action reports, final reports, certificates, PT study results and related documents. The Installation Compliance Laboratory, Bench Laboratory and water plant will also maintain copies of all records for a minimum of five years.

http://ilac.org/ilac-mra-and-signatories