A01_SOW_V9.docx

Statement of Work: For the ISO/IEC 17025:2005, TNI Standards:2009, EPA National Lead Lab Accreditation Program, Clinical Lab Improvement Amendments, ISO 15189 for Medical Labs Laboratory Accreditation Within the United States Army Public Health Enterprise:

Army Public Health Center (Provisional) (Aberdeen Proving Ground, MD), Regional Health Command – Pacific (Washington State), Public Health Command-Atlantic (Ft Meade, MD) Regional Health Command-Europe (Germany), Regional Health Command-Pacific (Japan), Regional Health Command DOD Food Analysis And Diagnostic Laboratory (FADL) – (San Antonio, TX)

BACKGROUND: The United States Army Public Health Enterprise (PHE) is seeking to renew its laboratory accreditations that must comply with a comprehensive list of standards and requirements as specified under natioanally and internationally accepted criteria for competence. They are ISO/IEC 17025:2005, AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmceuticals (dtd April 2015), The NELAC Institute (TNI) Standards:2009 for Chemical, Radiochemistry and Microbiology Testing, The EPA National Lead Laboratory Accreditation Program (NLLAP), Clinical Lab Improvement Amendments (CLIA), Clinical Laboratory Improvement Program (CLIP) and ISO/IEC 15189 for Medical Laboratories. This Contract will cover the PHE consisting of Army Public Health Center (Provisional) (Aberdeen Proving Ground, MD), Regional Health Command – Pacific: Public Health Command – Pacific (RHC-P: PHC-P) (Camp Zama, Japan); Regional Health Command – Pacific: Public Health Command – Pacific (RHC-P: PHC-P) (Joint Base Lewis McCord, Washington), Regional Health Command – Atlantic: Public Health Command - Atlantic (RHC-A: PHC-A) (Ft Meade, MD), Regional Health Command – Europe: Public Health Command - Europe (RHC-E: PHC-E) (Lanstuhl, Germany), and Regional Health Command – Central: Public Health Command – Central (RHC-C: PHC-C) (Joint Base San Antonio Fort Sam Houston, TX).

REQUIREMENTS: The Accrediting Body (AB) must be able to accredit various matrices to include air, drinking water, non-potable water, tissue, arthropods, soil, sediment, food, and clinical and veterinary specimens. The AB must be able to certify not only published methods, but also laboratory developed methods that meet validation and strict quality control requirements of the accrediting body. The AB must be internationally recognized by the International Laboratory Accreditation Cooperation (ILAC) and Regional Accrediation Groups according to ISO/IEC 17011 requirements. The AB must provide proof of a current existing scope that confirms that the AB accredits to the ISO/IEC 17025:2005, AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmceuticals (dtd April 2015), The NELAC Institute (TNI) Standards:2009 for Chemical, Radiochemistry and Microbiology Testing, The EPA National Lead Laboratory Accreditation Program (NLLAP), Clinical Lab Improvement Amendments (CLIA), Clinical Laboratory Improvement Program (CLIP) and ISO/IEC 15189 for Medical Laboratories. AB must be approved by the EPA for accrediting NLLAP laboratories and must have Deemed Status by the Centers for Medicare and Medicaid Services (CMS) under CLIA for clinical testing. PHE does not require state specific NELAC accreditation. The AB must have a reciprocity agreement as a third party accredition with the Washington State Department of Ecology and Georgia Department of Natural Resources to allow PHE to use this accredition for third party accredition in drinking water methods in those states. AB must have assessors possessing technical knowledge and experienced in chemical and biological analyses of food and veterinary medical specimens The following schedule details the current locations of individual laboratories, Field of Testing, Expiration of the accreditation, last onsite aseesment, and next required assessment. Individual laboratories posses a distinct accreditation and scope. The AB must be prepared to perform onsite assessments at each laboratory location and receive separate applications from each laboratory.

SCOPES: The scopes of accreditation being requested are found in the attachments that follows:

ATTACHMENT 1 – The Army Public Health Center (Provisional) scope of accreditation ATTACHMENT 2 – The (RHC-P: PHC-P) (Joint Base Lewis McChord, Washington) scope of Accreditation ATTACHMENT 3- The (RHC-A: PHC-A) (Ft Meade, MD) Scope of Accreditation ATTACHMENT 4 – The (RHC-E: PHC-E) (Landstuhl, Germany) Scopes of Accreditation ATTACHMENT 5 – The (RHC-P: PHC-P) (Camp Zama, Japan) Scope of Accreditation ATTACHMENT 6 – The (RHC-C: PHC-C) DOD FADL (JBSA Fort Sam Houston, TX) Scope of Accreditation In the near future,The PHE via the individual laboratory directors will be labs periodicially seeking to accredit published methods and internally developed methods on additional clinical, food, and environmental scope. PHE requires that the AB allow PHE to seek information regarding such accreditation for these methods to be added to the respective laboratory’s scope at any time during the year. AB agrees to add new testing methods/ matrices to scope within 14 calendar days of receiving complete and accurate verification/validation packets from the government for additions to scope. Comment by Nason, Seth B MIL: This section is ambiguous and suggests a scope change during contract execution for specified “To Be Determined” accreditations. Please clarify if there are specific scope changes to individual lab accreditations or remove this section from the statement of work. Comment by Taylor, Heidi L CIV USARMY MEDCOM PHC (US): Understood and agree. I would recommend 1 of 2 approaches The PHE does require the addition of additional methods throughout any given year. I would like to propose that we add a CLIN for additional methods be added to the scope when a quote is reviewed and approved by the COR with sufficient remaining funds on that CLIN.

The PHE loses the ability to add the methods to the scop within a timely manner since we would have to either have an additional contract or GPC purchase once a method is identified.

I have edited the document with option 1 in mind but would be happy to change it if you need me to go with option 2.

The AB must provide a fee structure and process that outlines the addition of new methods (both published and internally developed). This process must detail if the technology of the requested method is currently on the scope for a different method, whether an onsite audit would be required and any associated costs (acknowledging that travel may vary given the home location of the assessor)

The AB must provide a cost (if applicable) for an addition to the scope (ex. Hourly rate of the assessor) and any additional charges from the AB (ex. Processing or service fee).

The AB will forward a quote to the government COR for this requested addition for evaluation and approval. Once approved by the COR, the AB agrees to add new testing methods/ matrices to scope within 14 calendar days of receiving complete and accurate verification/validation packets from the government for additions to scope.

The following schedule details the current locations, Field of Testing, Expiration of the accreditation, last onsite sudit and next required audit. Each location is a distinct accreditation and scope. The AB must be prepared to perform onsite audits at each location and receive separate applications from each location.

AUDIT SCHEDULE & SPECIFIC REQUIREMENTS:

Location

Field of Testing

Expiration

Last Onsite Audit

Next Audit Required

August 2014

August 2016

(RHC-C: PHC-C) (JBSA FSH, TX)

Chemical

3/31/2016

March 2014

February 2016

(RHC-C: PHC-C) (JBSA FSH, TX)

Biological/ Veterinary Diagnostics

3/31/2016

February 2016

(RHC-C: PHC-C) (San Antonio, TX)

Clinical

1/6/2016

August 2016

APHC (Prov)

APHC (Prov)

APHC (Prov)

NOTE - Any audit that is required within 6 weeks of contract award must be given an extension from the AB of the current accreditation to ensure a lapse in accreditation is not experienced.

Laboratories will be assessed by Subject Matter Experts for the laboratory’s particular field of testing using appropriate comprehensive checklists. The assessors will review documentation, observe performance of each test procedure on the scope, and interview laboratory personnel to determine compliance and deficiencies. The assessor will provide a final outbrief at the onsite assessment. AB will forward a final detailed written report to the respective laboratory director and Contracting Officer’s representative (COR).

Accounting of Contract Services Cost for Providing Accounting for Contract Services – APG 5152.237-4900, Contractor is required to provide data on contractor manpower (including subcontractor manpower) for performance of this contract. The cost, if any, for providing this data shall be entered into the space provided at the appropriate CLIN. If no direct cost is associated with providing the data, enter “No Cost”.

Instructions, including the Contractor and Subcontractor User Guides, are available at the CMRA (Contractor Manpower Reporting Application) website at: https://cmra.army.mil For further assistance, email the CMRA Help Desk at contractormanpower@hqda.army.mil Reporting period will be the period of performance not to exceed 12 months ending 30 September of each government fiscal year and must be reported by 31 October of each calendar year

For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.