PWS - DDRP PED Testing.docx

Performance Work Statement (PWS)

1.1. The contractor shall provide to the Government all labor, materials, facilities, and equipment necessary to analyze the human urine specimens for anabolic steroids as defined in the Designer Anabolic Steroid Control Act of 2014 including subsequent amendments and all performance enhancing substances listed on the Office of the Under Secretary of Defense Memorandum “Department of Defense Special Drug Testing Panel,” April 24, 2024. All testing is under the regulations, directives, policies, and guidelines set forth by the current versions of the Department of Defense (DOD) Drug Demand Reduction Program (DDRP), DOD Instructions 1010.01 (Refer to Attachment 3: Military Personnel Drug Abuse Testing Program) and 1010.16 (Refer to Attachment 4: Technical Procedures for the Military Personnel Drug Abuse Testing Program), the World Anti-Doping Agency Code (WADAC), Article 6, Analysis of Samples (Refer to Attachment 5: World Anti-Doping Agency Code 2021 ) and subsequent revisions. The Contractor shall comply with all current guidelines and procedures and updates as published and distributed by the DOD, WADA, and the Contracting Officer’s Representative (COR).

1.2. Unless otherwise specifically provided for in this contract, the quality of all services rendered here under shall conform to the highest standards in the relevant profession, trade or field of endeavor. Individuals fully qualified in the relevant profession, trade, or field and holding any licenses required by law or regulation shall directly supervise all services rendered.

2. Subcontractors or Alternate Testing Sites or Laboratories

2.1. None of the services required by this contract shall be subcontracted to, or performed by, persons other than the contractor or the contractor’s employees without advance prior written consent of the contracting officer in advance of services.

2.2. All laboratories proposed for subcontracting that will be performing testing shall hold WADA accreditation, and the contracting officer shall approve all subcontractors.

2.3. The subcontracted laboratory shall agree to the terms and conditions of this contract.

2.4. The contractor shall incur any additional expenses in utilizing the subcontracted laboratory.

3. Scope of Work

3.1. The laboratory performing the testing shall reside in the continental United States (CONUS), furnish all labor, equipment, materials, and facilities to perform anabolic steroid and other Performance Enhancing Drugs (PEDs) explicitly listed in Classes S1, S2 and S4 of the World Anti-Doping Code Prohibited List testing on human urine specimens under the forensic and scientific specifications of the WADAC and the DOD DDRP Instructions.

3.1.1 Additional prevalence testing: the laboratory shall be able to perform analysis when requested by the Government on PEDs Classes S3, S5, S6 and S9 of the World Anti-Doping Code Prohibited List on human urine specimens or previously collected data. Prevalence analysis of erythropoietin (EPO) shall be provided upon request by the Government,

3.2. Certification Requirements: The laboratory performing the testing shall be a WADA accredited laboratory certified to perform anabolic steroid and other PED testing.

3.3. Proficiency Testing Requirements: The contractor shall participate in an independent proficiency program under WADA for PED testing throughout the term of the contract and demonstrate acceptable performance on blind and known positive and negative specimens. If a failure occurs within the proficiency program, the contractor is required to inform the Contracting Officer and COR of the failure and course of action taken.

3.4. Records and Manuals Review: The laboratory performing the testing shall make all records available to the Government for review within 30 days of request, to include, but not limited to, procedure manuals, reagent, calibrator, and control data, and instrument maintenance and service records.

3.5. Shipping and Receiving: The Government will ship specimens by commercial express courier under Chain of Custody to the contractor. The laboratory performing the testing shall receive specimens under Chain of Custody, maintain proper Chain of Custody and applicable records, and initiate testing upon receipt. The laboratory performing the testing shall confirm the information for the specimen and annotate any discrepancies. Any discrepancies shall be annotated and sent with the results when testing is completed.

3.6. Under circumstances when specialty command packages are used for priority specimens, the contractor shall be willing to ship packaging back to the command.

4. Performance Enhancing Drug Testing Procedures

4.1. Testing shall begin immediately upon receipt of the specimens. The laboratory performing the testing shall complete testing and report results for priority specimen testing, the laboratory performing the testing shall be able to complete testing and report results within 7 business days on average, but not to exceed 10 business days.

4.2. The laboratory performing the testing shall maintain specimen identity and integrity.

4.3. The laboratory performing the testing shall maintain all specimens in a secure area with limited and controlled access throughout all phases of processing, testing, and storage from receipt to destruction.

4.4. The laboratory performing the testing shall ensure that all aspects of the specimen accessioning, testing, and storage are under strict chain of custody with all signatures of involved individuals present.

4.5. The laboratory performing the testing shall ensure that all testing procedures are forensically and scientifically valid and that they meet the WADA standards and comply with their guidelines.

4.6. The laboratory performing the testing shall enlist testing procedures capable of detecting the substances listed in the WADA Prohibited List and the Anabolic Steroid Control Act of 2004, and any subsequent amendments/revisions.

4.7. The laboratory shall report elevated Testosterone (T) to Epitestosterone (E) (T/E) ratio (indicative of testosterone use) as "atypical findings", which is consistent with the WADA Code. The contractor shall identify additional markers if there is suspected Testosterone use, such as high concentrations of Testosterone, Androsterone, and other steroids.

4.8. Isotope ratio mass spectrometry (IRMS) testing shall be performed to determine if an atypical steroid profile is due to administration of an endogenous steroid. A urine sample in which any one of the following criteria is met during the screening procedure shall be submitted for IRMS analysis:

- T/E value equal or greater than 4;

- Concentration of testosterone or epitestosterone (equivalent to the glucuronide) greater than 200 ng/mL;

- Concentration of androsterone or etiocholanolone (equivalent to the glucuronide) greater than 10,000 ng/mL;

- Concentration of dehydroepiandrosterone (DHEA) (equivalent to the glucuronide) greater than 100 ng/mL.

4.9. The submitting laboratories shall be notified by email the same day IRMS testing is found to be required by the criteria stated in Section 4.8. Testing shall be initiated immediately after the order is funded (and in no case later than within 1 business day of funding notification).

4.9.1 Additional prevalence testing: Upon request by the Government, the laboratory shall perform IRMS confirmation testing on previously screened negative specimens.

4.10. The laboratory shall also test for anti-estrogenic drugs at no additional cost.

4.11. The laboratory shall test all specimens for human Growth Hormone Releasing Factors (GHRFs).

4.12. The laboratory performing the testing shall screen specimens by a reliable analytical method and confirm by a procedure accredited by WADA.

4.13. The laboratory performing the testing shall place all positive specimens in long-term, secure frozen storage for 365 days from the reporting date. This period shall be extended for an additional 365 days from the date when any request for litigation support is received by the laboratory or the laboratory is contacted to extend retention. Positive samples shall be discarded after 365 days from the reporting date. Negative samples shall be discarded after testing and prevalence testing is complete. The laboratory shall insure de-identification of Personally Identifiable Information (PII) is part of the specimen discard process.

4.14. The laboratory performing the testing shall maintain all records for positive and negative specimens to include test results, training records, quality control data, and instrument data for 3 years. The laboratory performing the testing shall comply with all Privacy Act regulations and policies in destruction of records. This period shall be extended by one-year increments, in cases where litigation support and or retention extension has been requested.

4.15. The contractor shall return all records and specimens that are still in storage within 45 days to the Government at the expiration or termination of the contract. The return of the records and specimens will be paid for by the Government. The return of records shall be in an expeditious manner that maintains the integrity of the PII contained therein. Similarly, specimens shall be returned frozen and in a manner that maintains the integrity of the specimens and any PII contained thereon.

4.16 The Contractor shall be able to process batches, not to exceed three hundred and fifty (350) service member specimens.

4.17 The Contractor shall be able to process up to twelve hundred (1200) service member specimens monthly.

5. Test Results and Reports

5.1. The contractor shall report test results for priority specimen testing, the laboratory performing the testing shall be able to complete testing and report results within 7 business days on average, but not to exceed 10 business days. Test results, reports, and associated documents shall be sent to the submitting laboratory via electronic mail as defined in the task order and shall contain sufficient detail to clearly decipher which tests were performed and the results of the same.

5.1.1. The laboratory performing the testing shall be able to provide results for batched specimens in a .CSV or similar format to include the laboratory accessioning number (LAN) and whether the specimen contained an adverse analytical finding (AAF) or no prohibited substance (NPS).

5.2 The laboratory performing the testing shall be able to report negative results separately within 24 hours of negative screen tests.

5.3. The laboratory performing the testing shall run a confirmatory test on all positive screen tests. (Pricing shall be inclusive of initial testing and possible confirmatory testing.)

5.4. The laboratory performing the testing shall not conduct research on specimens unless approved by the Government.

5.5. The contractor shall provide a monthly report to the COR via electronic mail no later than the 10th day of the month. This monthly report shall include a summary of orders placed that month by providing the following information:

- Contract Number,

- Date of Order,

- Date Received,

- Order Number,

- Contract Item Number,

- Description,

- Quantity,

- Unit Price,

- Total Amount,

- Submitting Laboratory, and

- Payment Method.

5.6. IRMS testing results for priority testing will be reported within 10 business days of notification.

5.7. The submitting laboratories shall be notified by email the same day IRMS testing is found to be required. Each order must be funded prior to testing.

6. Laboratory Management and Operations

6.1. The laboratory shall have a qualified individual to assume professional, organizational, educational, and administrative responsibility for the facility. This individual shall ensure that the contracted facility has current procedure manuals, a quality assurance program, a quality control program and a training and certification program. This person also ensures compliance with all regulations, guidelines, directives, and policies.

6.2. The laboratory performing the testing shall have laboratory certifying scientists who review and release results.

6.3. The contractor shall ensure customer service through designated points of contact.

7. Telephonic Consultation

7.1. The laboratory performing the testing shall have an expert available for telephonic consultation during normal business hours with the senior staff of the submitting agency.

7.2. The expert shall be able to discuss the scientific and forensic procedures of the laboratory. They shall be subject matter experts in the area of anabolic steroids.

7.3. The expert shall be able to interpret data and provide a meaningful synopsis to the submitting agency.

8. Inspections and Tours

8.1.The laboratory performing the testing shall allow the DOD DDRP to perform an inspection of services at the vendor/laboratory site in accordance with FAR 52.212-4 up to two (2) times per year.