A03 PWS ODDR_QA.pdf

PERFORMANCE WORK STATEMENT (PWS)

Office of the Under Secretary of War for Personnel & Readiness (OUSW(P&R)) Office of Drug Demand Reduction (ODDR)

Drug Demand Reduction Program Quality Assurance Services

May 28, 2026

Part 1

GENERAL INFORMATION

1. INTRODUCTION: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Drug Demand Reduction Program (DDRP) Quality Assurance Support Services as defined in this Performance Work Statement except for those items specified as government furnished property and services. The Contractor shall perform to the standards in this contract.

1.1. BACKGROUND: The DoW mandates urine drug testing for all Service members. The program was established in December 1981, and the technical requirements are codified under DoW Instruction 1010.16, “Technical Procedures for the Military Personnel Drug Abuse Testing Program”. The program is administered by the Office of Drug Demand Reduction (ODDR) within the Office of the Under Secretary of War for Personnel and Readiness (OUSW(P&R)), herein termed the Government. Current drug testing operations include >25,000 worldwide collection sites; five accredited Forensic Toxicology Drug Testing Laboratories (FTDTL); one support lab, and >4 million urine specimens tested annually for a panel of >25 drugs, including fentanyl, LSD, psilocin, and synthetic cannabinoids.

1.2. DESCRIPTION OF SERVICES: The Contractor shall provide forensic toxicology quality assurance (QA) support services in support of the Department of War (DoW) military drug testing laboratories. These services shall ensure that DoWs drug testing program is forensically sound, scientifically supportable, and efficient. These services shall include proficiency testing, inspection and evaluations of the five joint service military drug testing laboratories, reference materials, and consultation services. The services provide by the Contractor are in the capacity of an Independent Contractor. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the government.

The ODDR is responsible for technical oversight and accreditation of all military drug testing laboratories.

This includes maintaining an external quality assurance program to monitor the quality and accuracy of the analysis performed at each FTDTL. The quality assurance program was historically an internally governed program; however, to reduce costs and better align with National Laboratory Standards, a contract is being established for independent, external QA services.

DDRP Quality Assurance Services includes the open and blind proficiency program, inspection and evaluation of five FTDTLs, inspection coordination, reference material services, and consultation services.

The support services under this contract will encompass the labor, materials, and equipment necessary to support the accreditation of the DoW FTDTLs per guidelines set forth by DoW Instruction 10101.6 and ODDR policies.

1.3. OBJECTIVES:

• Management of the blind proficiency testing program, which includes the manufacture and distribution of blind proficiency specimens to all five participant laboratories (100 blind specimens per laboratory) as well as compiling and analyzing submitted results and report generation in accordance with DoW requirements.

• Management of the open proficiency testing program, which includes the manufacture and distribution of open proficiency specimens to all participant laboratories as well as compiling and analyzing submitted results and report generation in accordance with DoW requirements.

• Accreditation inspections, which include inspecting, evaluation, and assessment of all laboratory processes for forensic soundness, scientific supportability, and compliance with DoW requirements.

• Coordination of accreditation inspections, which includes scheduling, document preparation, inspection checklist maintenance, and trend analysis of inspection findings in accordance with DoW requirements.

• Reference material services to include the manufacture, distribution, and analysis for quality control materials to support validation of new methods or challenges to existing methods in accordance with DoW requirements.

• Scientific consultation to support forensic requirements for new instrumentation, testing methodologies, interference testing requirements.

1.4. SCOPE: The scope of the external QA services requirements ensures that FTDTL laboratory results are accurate, and procedures meet the required forensic, scientific, and quality standards established by the Government. The services specified in this contract shall be performed in accordance with current DoW requirements and the principles and ethics of the forensic toxicology profession. The quality of services provides shall meet or exceed the current recognized standards established by applicable Federal laws, ANSI/ASB standard 153-23, by the American academy of Forensic Sciences (AAFS), American Board of Forensic Toxicologists, Inc (ABFT), DoW Drug Demand Reduction Program, and those other professional associations that specify standards of performance for forensic toxicology such as the Society of Forensic Toxicologists. The Government may evaluate the quality of both professional, technical, and administrative services for purposes of contract inspection and acceptance. All functions will be conducted in accordance with the following:

• DOW Instruction 1010.01, “Military Drug Abuse Testing Program” (latest revision) (Attachment 1).

• DOW Instruction 1010.16, “Technical Procedures for the Military Personnel Drug Abuse Testing Program” (latest revision) (Attachment 2).

• Placeholder: need an ODDR issued version of the DoWQA inspection SOP (Attachment 3)

• The Contractor must demonstrate flexibility to adjust and accommodate to a dynamic work environment such as schedule changes, or interruptions resulting from weather or government shutdown.

1.5. PERIOD OF PERFORMANCE: The period of performance shall be for a phase-in period of 60 days, one

(1) base period of 12 months and four (4) 12-month option periods.

1.6. CONTRACT TYPE: The Government will award a hybrid contract that includes Firm Fixed Price (FFP), Contract Line Items (CLINs) for daily supplies and support, and optional Time and Material (T&M) CLINs for additional supplies and support.

1.7.

1.8.

1.9.

PLACE OF PERFOMANCE: The work to be performed under this contract will be performed at the Contractor’s primary site location with the exception of 5.4 and 5.6, which require work to be performed at a Government facility. Operating hours for the Government facilities are 7:00 AM to 5:00 PM, Monday through Friday.

TELEWORK: The COR will determine whether the work to be performed can be successfully accomplished offsite. Teleworking must be accomplished at no additional cost to the Government and with no detrimental impacts to contract performance. Contractor personnel may be required to report on onsite to a government facility to perform services at any time as required by the KO or COR.

HOURS OF OPERATION: The Contractor is responsible for providing services, between the hours of 7:00 AM to 5:00 PM Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the Contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. To ensure accessibility by appropriate Government representatives, the Program Manager (PM) or a designated alternate PM will be available by telephone for same day response within the hours of 0730-1630 Eastern Time (ET). The PM shall maintain the ability to immediately communicate with the Contractor’s workforce (inspectors) for situations requiring immediate response to requirements under this contract.

1.10. RECOGNIZED HOLIDAYS: Government personnel observe the following holidays as governed by 5 U.S.C. § 6103. Government facilities will be closed and unavailable to Contractor personnel:

*If the date falls on a Saturday, the Government holiday is the preceding Friday. If the date falls on a Sunday, the Government holiday is the following Monday.

In addition to the days designated as holidays, the Government observes the following days:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Any other day designated by the President’s Proclamation

1.11. QUALITY CONTROL/ASSURANCE

1.11.1 Quality Control: The Contractor shall prepare and adhere to a Quality Control Plan (QCP). The QCP shall document how the Contractor will meet and comply with the quality standards specified in the PWS, Quality Assurance Surveillance Plan (QASP), and the DDRP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this solicitation. The QCP shall be submitted to the Contracting Officer (KO) and Contract Officer Representative (COR) within 30 days after contract award and within 5 working days when changes are

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday

Columbus Day Washington’s Birthday Veterans Day Memorial Day Thanksgiving Day Juneteenth Independence Day Christmas Day made thereafter. After acceptance of the QCP, the Contractor shall receive the contracting officer’s acceptance in writing of any proposed change to his QC system.

1.11.2 Quality Assurance: The Government shall evaluate the Contractor’s performance under this contract in accordance with the QASP. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.12. PERSONNEL MATTERS

1.12.1 Key Personnel: Before replacing any Contractor employee designated as key personnel, the Contractor shall notify the COR and KO in writing at least 30 calendar days in advance. The Contractor’s request shall include a written justification along with the resume of the proposed key personnel substitution. All proposed personnel substitutions shall possess qualifications that are equal to or exceed the minimum requirements of PWS. The Contractor shall not unilaterally change its key personnel without written approval from the KO.

1.12.2 The following personnel are considered key personnel by the government: Program Manager (PM) The PM possesses the skills, knowledge, training, and certification(s) required to satisfactorily perform all services required by the contract.

1.12.3 The Contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the Contractor when the manager is absent shall be designated in writing to the Contracting Officer. The contract manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 0730-1630 Eastern Time (ET), Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

TASK KEY POSITION # OF FTES QUALIFICATIONS

5.1, 5.2, 5.3, 5.4, 5.5

Program Manager (PM) 1 FTE Education: Bachelor’s Degree in a relevant scientific field

Security: Secret

Minimum Qualifications:

• Minimum of five (5) years of relevant experience as a forensic toxicologist.

• Minimum of five (5) years of experience in the DoW Joint-Service Biochemical Testing Program environment, including knowledge of policy regulations pertaining to military drug testing, laboratory inspections, and drug testing laboratories.

• Minimum of five (5) years of operational experience with all aspects of a

Quality Assurance Program for drug testing, laboratory testing and reporting procedures for drugs of abuse.

• Hold a current Fellow or Diplomate status from the American Board of Forensic Toxicology (F-ABFT or D-ABFT).

Highly Preferred Qualifications:

• Minimum of five (5) years of experience managing a Quality Assurance Program to include proficiency testing, laboratory inspections, and laboratory certification.

Minimum of five (5) years leading accreditation inspections for DDRP

1.12.4 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or that they are Government officials. They must also ensure that all documents or reports produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12.5 Special Qualifications: Within five (5) days after award of this contract or after new employment five days of employment, the Contractor shall ensure that all Contractor employees complete and sign a Non-disclosure Agreement (NDA), and Contractor Conflict of Interest Form as identified in Technical Exhibit 2- Deliverable Table. The non-disclosure agreement and Contractor Conflict of Interest Form shall be signed by all Contractor employees supporting this effort and forwarded to the Contracting Officer’s Representative (COR).

1.12.6 The following training is required for onsite Contractor personnel: The Contractor shall submit certificates of completion for each affected Contractor employee and Subcontractor employee, to the COR or to the Contracting Officer. This training shall be completed and reported to the COR within 30 calendar days of contract award and annual refresher training for the remaining contract duration.

1.13. SECURITY

1.13.1 The contractor is not required to have a Secret Facility Clearance from the Defense Counterintelligence and Security Agency (DCSA). No classified materials will be accessed, and no classified performance will occur at the contractor's facilities.

1.13.2 Key personnel and the alternate referenced in 1.12.3 performing work under this contract shall have a secret clearance at time of the end of the transition period and shall maintain the level of security required for the life of the contract. The security requirements are in accordance with the attached DD254 (The unit security monitor is responsible for initiating this form).

1.13.3 On-site FTDTL inspections will require the Contractor’s compliance with DoW Agency’s personnel security regulations identified in Part 6, Applicable Publications. Contractor personnel performing on-site inspections must be able to obtain building/installation passes and meet any additional personnel security requirements for building/installation access.

1.13.4 The Contractor shall be responsible for safeguarding all Government equipment, information and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of Government data. At a minimum, this shall include provisions (as applicable) for personnel security, electronic security and physical security as listed in the following sections:

• Personnel Security: The Contractor shall comply with DoW Directive 8500.01E, “Information

Assurance (IA),” October 24, 2002; DoW Instruction 8500.2, “Information Assurance (IA) Implementation,” February 6, 2003; DoW Directive 5400.11, “DoW Privacy Program,” DoW 6025.18-R; DoW 5200.2-R, “Personnel Security Program Requirements,” January 1987 with change 3 February 23, 1996. Contractor responsibilities for ensuring personnel security include meeting the following requirements:

• Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities to include the ability to acquire a Common Access Card (CAC).

• Immediately report to the OUSW (P&R) Privacy Office if a Contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate government representative for security reasons.

• Ensure that all Contractor personnel receive information assurance (IA) training before being granted access to DoW information and data as related to this requirement.

• Files Security: All non-DoW (vendor) information systems that process, store, or transmit DoW information, including PII and PHI must be safeguarded in accordance with all basic security and safeguarding requirements and cyber incident reporting in NIST SP 800-171” Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations” and DFARS 252.204-7012. These requirements extend to any external cloud service providers used by the Contractor. Contractors are required to complete Level II Cybersecurity Maturity Model Certification assessments annually. In addition to the abovementioned requirements, Contractor-owned IT software / IT Systems shall be maintained and updated to accurate reflect documentation of file records and reports as required under the terms of this contract (such as Chain of Custody forms) and HHS guidelines. The Contractor shall not allow access to the files by any Government agency, non-Government agency or individual unless specifically authorized by the COR, KO, or DoW Policy. Files will be made available to the KO, or the COR upon request. The automated data files are the property of the Government and will be turned over to the KO or the COR at the completion or termination of this contract. A daily backup of computer records and files shall be performed. Multifactor authentication procedures shall be used for all donor and research records. Information systems must provide adequate security for unclassified information not intended for public release, to include PII and PHI.

• Documentation: Documents, data files, reports, correspondence, and all other documents and writings, together with any charts, graphs, tables, illustrations, photographs, images, and other illustrative explanatory, historical documents related thereto or independent thereof, regardless of the medium (or media) by which they were produced, preserved, stored, or created in connection with or for purpose(s) of work performed under this PWS and contract, are property of the Government and shall be delivered to the COR promptly, upon request.

• The Contractor agrees to assume responsibility for protecting the confidentiality of

Government records, which is not considered public information. Each Contractor or employee of the Contractor to whom information may be made available or disclosed shall be notified in writing by the Contractor that such information may be disclosed only for purposes and to the extent authorized herein. The Contractor shall not release any information related to this contract to the public, media or other unauthorized persons or organizations unless the government has conducted the appropriate security review and granted written approval (e.g.

posting information to a public website). The Contractor shall not publish or disclose in any manner, without the Contracting Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government. To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of Government data, the Contractor shall afford the Government access to the Contractor’s facilities, installations, technical capabilities, operations, documentation, records, and databases pertaining to the requirements listed in this PWS. If either the Government or the Contractor discovers new or unanticipated threats or hazards, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.

• The Contractor shall retain all Government data acquired and produced in the normal course of business in accordance with DoWI 1010.16 and ODDR requirements according to the following schedule:

Document Length of Time Retained (years)

Blind Monthly Proficiency Reports 5 Operating Procedures 5 Results of Blind QCs (data provided by

ODDR) 1

Open Proficiency Reports 5 Certified Laboratories' Open data (data submitted by the labs) 1

Contractor Monthly Open Proficiency Testing Data 3

Certification and Challenge Sets Summarized Results & Data 5

Summary and Data of Special Testing Projects (Consultation services) 5

Control preparation and certification results & data 3

Inspection Reports 5 Inspection trend analysis 5

1.14. CONTRACT ADMINISTRATION

1.14.1 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference(s) convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the contracting officer will apprise the Contractor of how the government views the Contractor's performance and the Contractor will apprise the Government of problems, if any, being experienced.

Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.14.2 Phase-In/Phase-Out Period: To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the 60 calendar days phase-in period and during 90 calendar days phase-out period. During the phase-in period, the incoming Contractor shall become familiar and execute with performance requirements in order to commence full performance of services on the contract start date for the PWS task areas described in Section 5. The Contractor shall follow its transition plan submitted as part of their proposal and keep the Government fully informed of status throughout the transition period.

Throughout the phase-in, it is essential that attention be given to minimize interruptions or delays to work in progress that would impact the mission. The Contractor must plan for the transfer of work control, delineating the method for processing and assigning tasks during the phase-out period.

During the phase-out period, the exiting Contractor shall coordinate with incoming Contractor as necessary to ensure a smooth transition of performance.

• The Contractor is responsible for executing the phase-in plan previously submitted. The plan must be detailed and include start-up activities required to transition to full operational capability to successfully assume all duties under this PWS. The transition plan must be provided to the government at proposal submission, and at a minimum, the contract shall provide a detailed transition methodology in logical sequence to ensure a smooth transition of all tasks/subtasks of the contract without interruption or degradation of service levels; a timeline for completion; and identification of all associated risk, issues and risk mitigation strategies.

• The Contractor shall submit a phase-out plan to include the transfer of work control, delineating the method for processing and assigning tasks during the phase-out period. The succeeding Contractor must observe operations and performance methods of the Contractor.

The Contractor must allow the succeeding Contractor reasonable, finite access to the Contractor’s laboratory/site facility to the degree deemed necessary to ensure the orderly transfer of specimens, materials, and functions. The phase-out period shall not exceed 90 calendar days. The Contractor must not defer any requirements or transfer such responsibility to the succeeding Contractor before the end of the last performance period.

• Unless the COR specifies otherwise, during the phase-out period, the Contractor shall complete the testing and reporting of all samples on hand. A complete inventory of all records, specimens, and materials on hand and on order will be provided to the COR.

• All records supporting every proficiency specimen, certification set, challenge set, and inspection documentation belong to the government. The government may require all records be transferred to the succeeding Contractor.

1.14.3 Monthly Invoice Reports: The Contractor shall provide electronic (PDF format) copies of invoices on a monthly basis to the COR for audit review of charges. The COR may reject or require correction of any deficiencies found in the invoice or receiving report. In the event of a rejected invoice or receiving report, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor is responsible for properly preparing and forwarding to the appropriate Government official, invoices and receiving report for payment. The Contractor shall invoice in accordance with the Wide Area Workflow (WAWF) invoicing instructions.

1.14.4 Monthly and Periodic Reports: The Contractor will provide reports based on the schedule below. Note: the COR may request to receive these reports on a more frequent basis. All reports will be submitted electronically via email and the email address will be provided upon contract award.

Report Timeline Min. Elements

Monthly Blind PT Report 15 days after the end of the month See task 5.1

Quarterly Blind PT Report 45 days after the end of the quarter See task 5.1

Monthly Open PT Report 15 days after the result reporting deadline See task 5.2

Quarterly Instrument Performance Report 30 days after the end of the quarter See task 5.2

Inspection Reports 15 days after the last day of the inspection See task 5.4

Post-Inspection Cycle Trend Reports 30 days after the closing of each tri-annual inspection cycle See task 5.5

Special Reports 30 days See task 5.3 and 5.6

1.15. TRAVEL/TDY/DEPLOYMENT

1.15.1 Contractor Travel: All travel to/from sites specified in Technical Exhibit 5 is included in the price of this contract. The Contractor will be authorized travel expenses consistent with the substantive provisions of the Joint Travel Regulation (JTR) and the limitation of funds specified in this contract. Travel associated with inspection and evaluation of military drug testing labs and consultant services shall be conducted in accordance with Joint Travel Regulations (JTR) as prescribed by the General Services Administration (http://www.defensetravel.DoW.mil/site/travelreg.cfm). For the purposes of this contract, travel is defined as all inclusive of transportation, lodging, and per diem costs associated with inspection and evaluation of the sites and consultant services. Salaries are not included in travel. All travel requires prior Government approval/authorization and notification to the COR.

1.15.2 The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel costs incurred during performance of this effort in accordance with the FAR 31.205-46 "Travel Costs." Requests for approval of costs in excess of maximum per diem rates in accordance with the procedures contained in FAR 31.205-46(a)(3) must be submitted to the COR for final approval prior to commencement of travel.

1.15.3 All local travel in support of this contract (i.e., any travel within a 50-mile radius of the NCR) is included in the price of this contract and is not reimbursable. All local travel costs shall be borne by the Contractor, nor will the Government reimburse Contractor personnel commuting costs (i.e., parking expenses, public transportation fares such as Metro, Virginia Rail Express, vanpool or bus, and/or highway tolls, etc.).

1.15.4 Synchronized Pre-deployment Operational Tracker (SPOT): (USE ONLY WHEN APPLICABLE). PLEASE REMOVE THIS PARAGRAPH IF NOT APPLICABLE. If Outside Continental United States (OCONUS) travel is required, the Contractor shall register and maintain an account in the Synchronized Pre-deployment and Operational Tracker (SPOT) web-based system (https://spot.dmdc.mil/privacy.aspx). The Contractor shall identify a Company Administrator (CA).

The CA is an individual who works for the company and provides support under the contract. The CA is required to update and maintain personal information on all deployed Contractor personnel, including subcontractors, throughout their deployment or temporary duty travel (TDY). This includes maintaining Contractor personnel duty status, permanent duty location and closing out all deployments or TDYs. It is the CA’s duty to ensure that appropriate communication channels are established with deployed personnel to maintain this information in an accurate and timely manner.

The CA shall enter all required information before deployment/TDY and maintain data for all Contractor personnel to include subcontractors. The Contractor/CA shall use SPOT to enter and maintain the data.

1.15.5 If OCONUS travel is required, the COR shall advise the Contractor of any authorized Government services (which are identified in the table below) and complete the following information in SPOT.

CONTRACTOR STATUS

☐ CAAF ☐ NON-CAAF

AUTHORIZED GOVERNMENT SERVICES*

☐WEAPON** ☐MILITARY ISSUED CLOTHING

☐BILLETING ☐MILITARY ISSUED EQUIPMENT

☐CAC ☐MWR FACILITIES

☐LOCAL ACCESS BADGE ☐MILITARY EXCHANGE

☐DINING FACILITY (DFAC) ☐COMMISSARY

☐GOVT FURNISHED MEALS (GFM) ☐MILITARY BANKING

☐APO/FPO/POSTAL SERVICES ☐EXCESS BAGGAGE

☐DIPLOMATIC POST OFFICE (DPO) ☐MILAIR

☐PRIMARY CARE*** ☐TRANSPORTATION (other than MILAIR)

☐OTHER (SEE REMARKS FIELD) ☐NONE

Authorized Government Services does not necessarily mean that the Government provides these services to contractors on a non-reimbursable basis. For certain categories of authorized services, the contractor may be required to reimburse the government IAW applicable Federal, DOW or CCMD regulations/policies and/or the contract terms and conditions. The indicated Authorized Government Services on this LOA are only applicable for the designated countries to be visited during the deployment; however, if the services vary between countries, the contracting officer shall specify which services may be authorized in each country. If the country to be visited has a Status of Forces Agreement (SOFA) in place that governs the categories of services to be authorized, then the terms of the SOFA take precedence over the terms of this

LOA.

**Combatant Commander (CCDR) authorization is required IAW FAR Clause 52.225-26 for a contractor to be authorized to carry a weapon.

***Resuscitative/Emergency Care is the default level of care. Unless specifically negotiated in the contract, ALL medical care is reimbursable to the U.S. Government.

Contractors Authorized to Accompany the Force (CAAF) personnel are granted a Letter of Authorization (LOA) by the KO, authorizing them to accompany the military. Non-CAAF contractor personnel do not have this LOA. Contractor personnel shall receive authorized services based on CAAF or Non-CAAF status as defined in DFARS 252.225-7040, Contractor Personnel Supporting U.S. Armed Forces Deployed Outside the United States.

The Contractor is responsible to close out the deployment of personnel, including subcontractor employees, at the end of the contract completion period and to release the personnel in the SPOT database in accordance with DFARS 252.225-7040. The release of employee information must be accomplished no more than 30 calendar days after the end of the contract completion date.

Accountability of Prime and Subcontractor Personnel: The Contractor shall be responsible for ensuring that any Contractor personnel deployed or TDY for purposes of performing work under this contract, shall be returned to their point of origin/home once the deployment or TDY is completed. Failure by the Contractor to ensure its personnel, (including subcontractor personnel at any tier) return home after deployment or TDY could result in the Contractor being placed on the Excluded Parties List System (EPLS) and being barred from being awarded future contracts with the U.S. Government.

1.16. OTHER DIRECT COST (T&M and LH):

1.16.1 Other Direct Costs: The Contractor will be required to provide supplies as identified in Technical Exhibit 6, Collection and Laboratory Supplies. The Contractor may incur costs associated with the procurement of the collection and laboratory supplies required to meet the requirements of PWS Tasks 5.1, 5.2, and 5.3 in accordance with the guidelines identified in Technical Exhibit 6, Collection and Laboratory Supplies. The Other Direct Costs for collection and laboratory supplies will be procured under a Time and Material (T&M) CLIN. The Contractor shall comply with the FAR clause 52.212-4 Alt 1 requirements pertaining to materials, to include “obtaining materials at the most advantageous prices available with due regard to securing prompt delivery of satisfactory materials,” and the submission of “[a]ny invoices or subcontract agreements substantiating material costs.”

1.17. DATA RIGHTS:

1.17.1 Data Rights: Refer to FAR Clause 52.227-14 “Rights in Data – General” and Defense Federal Acquisition Regulation Supplement (DFARS) 252.227-7015 “Technical Data – Commercial Products and Commercial Services.” The Contractor agrees to assume responsibility for protecting the confidentiality of Government records, which are not considered public information. Each Contractor or employee of the Contractor to whom information may be made available or disclosed shall be notified in writing by the Contractor that such information may be disclosed only for purposes and to the extent authorized herein. The Contractor shall not release any information related to this contract to the public, media or other unauthorized persons or organizations unless the Government has conducted the appropriate security review and granted written approval (e.g., posting information to a public website).

1.17.2 Data and Artificial Intelligence: The use of public, non-enterprise AI tools (e.g. public ChatGPT, Gemini, Claude, Copilot) with any government data, reports, and documents is effectively prohibited per FAR 52.204-21, FAR 52.239-1.

1.17.3 Data Use Agreement: A Data Use Agreement (DUA) is a contractual agreement between outside entities and the DoW to ensure that Protected Health Information (PHI) or Personal Identifiable Information (PII) is used appropriately and is not disclosed to unauthorized individuals or organizations. Any Contractor, non-DoW-organization, or non-DoW Agency requesting a data extraction from systems belonging to the Military Health System (MHS) should formally request a DUA, which must be approved by the ASD (HA) in accordance with the requirements of the HIPAA Privacy Rule and the DoW 6025.18-R, “DoW Health Information Privacy Regulations”, January 24, 2003, Section C8- “Special Rules and Other Requirements Relating to Uses and Disclosures of Protected Health Information”. DUAs are active for one year, after which the Contractor must submit a renewal request or provide a Certificate of Data Destruction (CDD) to the ASD (HA) Office.

1.17.4 Privacy Impact Assessment: The Contractor shall provide for the completion of a Privacy Impact Assessment (PIA) for any applicable system that maintains Protected Health Information (PHI) or Personal Identifiable Information (PII) and systems that retrieve such PII through the use of personal identifiers. The PIA will be prepared according to the DoW PIA format, which is specified in DoW Instruction 5400.16, “DoW Privacy Impact Assessment (PIA) Guidance,” February 12, 2009. Completed PIAs will be sent to the ASD (HA) Privacy Office.

1.18. CONFLICT OF INTEREST

1.18.1 Organizational Conflict of Interest/Personal Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5 as well as Personal Conflicts of Interest. Using the Contractor OCI/COI Disclosure Form, the Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential conflict and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such conflict.

1.18.2 The Contractor’s mitigation plan will be reviewed and accepted/rejected solely at the discretion of the Government, and in the event the Government unilaterally determines that any such conflict cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the conflict.

1.18.3 In addition, Contractors shall conduct internal reviews as necessary to identify financial interests and determine if any personal conflicts of interest exist or may arise. The Contractor shall ensure that the organization has analyzed each financial disclosure to determine whether actual or potential conflicts exist. Information should be gathered and analyzed for all governing body members (e.g., board of directors, trustees, etc.) and principals of the organization as defined by FAR 52.203-13 and for each manager and key personnel who would be or are involved with the performance of the contract.

1.18.4 All Contractor and Subcontractor employees supporting this contract shall sign the WHS AD non-disclosure agreements.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1 DEFINITIONS

2.1.1. BUILDING. A permanent structure, with a roof, that is used for a variety of purposes, such as offices or manufacturing. Buildings are real property.

2.1.2. COMMANDER/COMMANDING OFFICER. The senior Officer who is responsible for the operation of the drug-testing laboratory.

2.1.3. CONTRACTING OFFICER. A person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.4. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

• Contracting Officer Representative (COR): The COR will be identified by separate letter. The

COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

2.1.5. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.6. CONTRACTOR PERSONNEL. A person employed by or under contract to the Contractor to provide services under this contract.

2.1.7. CREDENTIALS. Record of education, clinical experience, medical or professional licenses, professional performance and continuing education that confirms that an individual is professionally competent.

2.1.8. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.9. DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

2.1.10. INDEPENDENT CONTRACTOR. The services provided by the Contractor are rendered in the capacity as an independent, non-personal services Contractor. The Government may evaluate the quality of professional, technical, and administrative services for the purposes of contract inspection and acceptance.

The Government retains no direct control of the Contractor or their personnel and how they render services.

The Contractor shall be solely responsible for any and all liability caused by acts or omissions of its agents or personnel. The Contractor shall not in any manner represent or infer that it is an instrument or agency of the United States Government. The Contractor shall recognize that the Commanding Officer of the laboratory maintains administrative and operational responsibility for all activities at the laboratory. This includes taking such actions as necessary to preserve and maintain the integrity of the command, subject to the limitations prescribed by law and DoW regulations.

2.1.11.KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.12. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.13. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.14. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of Contractor performance.

2.1.15. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.16. SUBCONTRACTOR. One that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

2.1.17. TRAVEL. For the purposes of this contract, travel is defined as all-inclusive of transportation, lodging, and per diem costs associated with inspection and evaluation of the sites, and consultation services. Salaries are not included in travel.

2.1.18. WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.19 WORK WEEK. Monday through Friday, unless specified otherwise

2.2 ACRONYMS

ACOR Alternate Contracting Officer's Representative AFARS Army Federal Acquisition Regulation Supplement ANSI/ASB American National Standards Institute/Academy Standards Board AR Army Regulation CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DDRP Drug Demand Reduction Program DOI Department of the Interior DFARS Defense Federal Acquisition Regulation Supplement DOW Department of War FAR Federal Acquisition Regulation FTDTL Forensic Toxicology Drug Testing Laboratory GFE Government Furnished Equipment GFI Government Furnished Information GFP Government Furnished Property HIPAA Health Information Portability and Accountability Act ID Identification KO Contracting Officer LSD Lysergic acid diethylamide

MS Microsoft OSHA Occupational Safety and Health Administration OUSD (P&R) Office of the Under Secretary of Defense for Personnel and Readiness OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs PDF Portable Document Format PHI Protected Health Information PIPO Phase In/Phase Out PL Public Law PM Program Manager POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan

QC Quality Control QCP Quality Control Program QASP Quality Assurance Surveillance Plan SSN Social Security Number TE Technical Exhibit

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVIES:

3.1. Services: The Government will provide basic services, such as access to the restroom while working in Government facilities.

3.2. Facilities: The Government will provide basic facilities such as workspace that includes a desk/table and chair while working in Government facilities.

3.3. Utilities: The Government will provide electricity while working in Government facilities; however, wireless internet may not be available at all Government facilities.

3.4. Equipment: The Government will not provide laboratory equipment and instrumentation.

3.5. Materials: In the context of this contract, Government Furnished Information (GFI) shall be accessible via the government-provided, electronic platform(s) for the DoW’s drug testing program. Access to the system shall be provided by the government to the Contractor (under the terms of this contract) and throughout the performance of this effort. The Government may also provide information or records to fulfill the contract requirements.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNIHSED ITEMS AND RESPONSIBLITIES:

4.1. General: The Contractor shall ensure access to records of proficiency testing drug results, FTDTL inspection reports, and that associative personnel identifiers are secured. The Contractor shall establish processes consistent with the Privacy Act of 1974, and applicable DoW Directives or Instructions. Access to records and data files shall also be accessible to designated DoW Drug Demand Reduction Program (DDRP) management personnel.

4.1.2. Personnel: The Contractor shall furnish all personnel required to perform work under this contract, in addition to providing all necessary personal supplies (e.g. office supplies, etc.). The Contractor shall comply with the Workers Compensation Insurance Laws of the state in which they are incorporated.

4.1.3. Secret Facility Clearance: Not Applicable

4.1.4. Equipment: The Contractor must provide all necessary laboratory equipment, instrumentation, and supplies, which includes but is not limited to refractometers, immunoassay analyzers, liquid chromatography tandem mass spectrometry and other equipment utilized in forensic drug testing. All instrumentation must be validated and maintained by the original equipment manufacturer (OEM) or an OEM certified person.

4.1.5. Standard Operating Procedures: The Contractor must have established operating procedures for all tasks to include: preparation and certification of urine pools, calculations for drug spike volumes, negative blind, positive blind, and intentional discrepant blind preparation, pouring, and shipping, preparation of reference materials, analytical testing methods, instrument operation and maintenance, and conduct of accreditation inspections. Standard Operating Procedures (SOPs) must be version controlled, up-to-date, and provided to the government upon request.

4.1.6. Training: The Contractor shall provide training to ensure that all employees have been properly trained and are qualified to perform assigned tasks associated with laboratory instrumentation and equipment and urine specimen preparation under this PWS in accordance with DoWI 1010.01 and DoWI

1010.16. Contractor personnel will be trained annually in accordance with Federal privacy guidelines associated with the Health Insurance Portability and Accountability Act of 1996 (HIPPA), Privacy Act System of Records Notice, and DoW information assurance and security regulations.

4.1.7. On-site Facility: The Contractor will ensure that the laboratory facility is a well-designed, secure, highly organized, and equipped with instruments and…