PWS Drug Testing and MRO Services 2.docx

PERFORMANCE WORK STATEMENT

United States Space Force Deputy Chief of Space Operations for Personnel (SF/S1) Drug Testing and Medical Review Officer Support Services 25 August 2026

Part 1 General Information

1. GENERAL: This is a non-personnel services contract to provide pre-employment Civilian Drug Free Workplace Collections and Medical Review Officer (MRO) Support Services for the United States Space Force (USSF). 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 turnis responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform pre-employment Civilian Drug Free Workplace Collections and MRO Support Services as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall meet all standards in this contract.

1.2 Background: In the late 1980s, Federal Agencies were required to begin drug testing civilian employees in Testing Designated Positions (TDPs) in accordance with Department of Health and Human Services (HHS) guidelines. Under these guidelines, the DoD Civilian Employee Drug Testing Program—administered by the Office of the Under Secretary of Defense for Personnel and Readiness (OUSD (P&R))—was codified in DoD Instruction 1010.09, "DoD Civilian Employee Drug-Free Workplace Program" (June 22, 2012).

1.2.1 The requirement to conduct pre-employment civilian drug testing was placed on the Department of War (DoW) agencies and Military Services, which, in turn, developed separate programs governed by separate DoW Directives. In an effort to meet the need to conduct drug testing under HHS guidelines, the Department of Interior (established a drug testing services contract through its National Business Center. Subsequent contracts have been used to facilitate the specimen collection and medical review services, while laboratory analysis was conducted at a DoW laboratory certified by HHS.

1.2.2 Pre-employment Civilian Drug Testing Services include specimen collection, facilitation of specimen collection, and MRO support services. The support services under this contract will encompass the labor, materials and equipment necessary for the collection, documentation, medical review, and results reporting for specimens collected from USSF Guardians and applicants, per guidelines set forth by HHS as part of the pre-employment process. Conducting the final review of drug testing results is an essential component of any drug testing program. Under the HHS guidelines, all testing results shall be reviewed by a certified MRO which includes the functions of conducting these final reviews and donor interviews, as well as interpreting test results while providing sound reporting and documentation of results. This contract does not require urine testing services except as specified under PWS Section 5.5, MRO Testing Support Services. Specimens must be shipped to the designated DoW laboratory in accordance with HHS guidelines.

1.2.3 The pre-employment Drug Testing Services under this contract apply to both applicants and current Government employees employed by USSF. The projected annual testable TDP population is based upon a number of variables to include pre-employment civilian drug testing rates, number of applicants who require pre-employment drug testing, the potential addition of l TDPs, and Federal workforce expansion or decrements based on Congressional actions. All USSF pre-employment drug collections are contract supported collections conducted at a clinic. Specimen collection will include approximately 1,500 collections. Collection supplies, as identified in Technical Exhibit 6, and MRO support services will be required for approximately 1,500 specimen collections, regardless of whether these specimens are collected by the contractor or by Government. As needed, the Government can exercise a time and materials option for up to 1,500 additional MRO services, collection services, and/or collection supplies (identified in Technical Exhibit 6).

1.3 Objectives:

The overall objective(s) of this requirement is for the contractor to:

a. Provide access to worldwide system clinics with forensic urine collection capabilities consistent with HHS guidelines.

b. Provide collection supplies (e.g., HHS-approved forms (eScreen eCCF and CCFs), bottles and overnight shipping supplies) for all collection sites, even where the contractor does not conduct collections.

c. Partner with USSF, AFMEDCOM, and DoW to enhance compliance with the DoW Civilian Employee Drug-Free Workplace Program requirements (DoD Instruction 1010.09).

d. Develop and maintain an internal quality assurance review process to identify and correct deficiencies or discrepancies in the execution of this PWS consistent with HHS guidelines.

e. Provide MRO Services of urinalysis drug testing results for review reporting, and documentation consistent with DoW and HHS regulations.

f. Provide statistical reports detailing the Services provided.

1.4 Scope: The scope of this requirement provides for all required pre-employment civilian drug testing services of TDPs associated with the Unites States Space Force. The pre-employment civilian drug testing under this PWS includes support services associated with off-site clinic specimen collection using forensic procedures, providing collection supplies, and MRO support for all USSF Civilian TDPs and applicants requiring pre-employment drug tests. The MRO serves as the common point of contact between all parties involved in a pre-employment drug test (i.e., the donor, the collector, the laboratory, and the USSF designated representative). MRO support services include:

(1) reviewing lab test results and specimen custody and control forms (CCFs) to verify forensic and scientific reliability;

(2) conducting donor interviews;

(3) making determinations regarding test results;

(4) reporting verified test results to employer/USSF;

(5) maintaining records and confidentiality of drug testing information; and

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 12-month base period and one 12-month option.

1.6 General Information

1.6.1 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 all HHS requirements relating to the Drug Free Workplace program. 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 CO and COR within 30 days after contract award and within 5 working days when changes are made thereafter. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to the QC system.

1.6.2 Quality Assurance: The Government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. 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).

1.6.3 Recognized Holidays: The contractor may be required to perform service on holidays to include:

Independence Day

1.6.4 Hours of Operation: 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 contractor shall provide an answering service or a direct phone or cell phone contact for after-hours, weekend and holiday contact with response required within one hour. The PM shall maintain the ability to immediately communicate with the contractor’s workforce (MROs and collection staff) for situations requiring immediate response to requirements under this contract.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at the contractor’s primary office site location. The conduct of civilian employee and applicant urinalysis collections will occur at clinics and on-site worldwide locations in accordance with this PWS. Technical Exhibit 5 contains an example of locations where collections may occur. The locations cited do not imply that these are the only locations where collections may occur over the course of this contract.

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

1.6.7 Special Qualifications: Within five (5) days after award of this contract or 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. 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).

In addition, this section identifies responsibilities that the key personnel will be performing in support of this PWS. The responsibilities include the following:

a. Program Manager (PM): The PM possesses the skills, knowledge, training, and certification(s) required to satisfactorily perform all services required by the contract.

b. MRO (MRO): The MRO performs the forensic documentation review and interpretation. The MRO must be knowledgeable about the following:

i. Controlled substances abuse disorders, including knowledge of alternative medical explanations for laboratory confirmed drug test results.

ii. Issues relating to adulterated and substituted specimens as well as the possible medical causes of specimens having an invalid result.

iii. 82 FR Part 7920-7970 (October 1, 2017) Mandatory Guidelines for Federal Workplace Drug Testing Programs.

Note. The minimum qualifications needed for Key Personnel are listed in PWS section 1.6.11.

1.6.8 Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference 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.

1.6.9 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.

1.6.10 Key Personnel: The contractor shall provide qualified personnel for the key positions under this contract. The Key Personnel under this contract are as follows:

Minimum Qualifications:

· Must be currently licensed and MRO certified. Knowledge of substance use disorders, specimen tampering, and all applicable guidelines associated with the federal Drug-Free Workplace Program

Highly Preferred Qualifications:

· One (1) year MRO experience for the Federal Drug Free Workplace Program

1.6.10.1 During the first 90 calendar days of performance, the contractor shall make no substitutions of key personnel without the approval of the Contracting Officer and Contracting Officer Representative (COR), unless illness, death, or termination of employment necessitates the substitution. The contractor shall notify the Contracting Officer and COR within 48 hours after the occurrence of any of these events and provide the information required below.

1.6.10.2 After the initial 90 calendar day period, the contractor may propose a substitution. The Contractor produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.6.10.3 MRO Licensing and Professional Liability Insurance: The contractor shall provide evidence that all MROs maintain at least the minimum amount of malpractice/medical liability insurance required by state, commonwealth, district or territory licensing requirements for the specific MRO location in which they are providing contract support services. The contractor shall ensure and provide to the COR that all MROs performing services under this agreement have current licenses, registrations, and/or certifications according to industry standard and as required for the specific MRO location, state, commonwealth, district, or territory in which they are providing contract services. A copy of each MRO’s credentials will be forwarded to the COR annually, as identified in Technical Exhibit 2-Deliverable Schedule.

1.6.11 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 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.

1.6.13 Other Direct Costs: The contractor will be required to provide supplies as identified in Technical Exhibit 6, Collection Supplies. The contractor may incur costs associated with the procurement of the collection supplies required to meet the requirements of PWS Tasks 5.2 and 5.5 in accordance with the guidelines identified in Technical Exhibit 6, Collection Supplies. The Other Direct Costs for the collection supplies will be procured under a 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 any invoices or subcontract agreements substantiating material costs.

1.6.13.1 Cancellations and No-Shows: The Government will not provide payment for cancellations and no-shows.

1.6.14 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 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).

1.6.14.1 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. AFMEDCOM and MAJCOM DDRPM will extract data for USSF.

1.6.14.2 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 DoD Instruction 5400.16, “DoD Privacy Impact Assessment (PIA) Guidance,” February 12, 2009. Completed PIAs will be sent to the ASD (HA) Privacy Office.

1.6.14.3 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.

1.6.14.4 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.

1.6.14.5 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:

1.6.14.5.1 Health Insurance Portability and Accountability Act (HIPAA): The contractor shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (P.L. 104-191) requirements, specifically the administrative application of provisions of the law, as well as the Department of Defense (DoD) 6025.18-R, “DoD Health Information Privacy Regulation,” January 2003. This includes the Standards for Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information and the Security Standards. It is expected that the Contractor shall comply with all HIPAA related rules and regulations as they are published and other requirements are defined to include identifiers for providers, employers, health plans, and individuals, and standards for claims transactions.

1.6.14.5.2 Systems of Record: In order to meet the requirements of 5 U.S.C. 552a, the Privacy Act of 1974, contractors shall assist the ASD (HA) Privacy Office in completing or amending a Privacy Act System of Records Notice for collections of records where information in identifiable form is retrieved. The contractor will also comply with the requirements in Office of Management and Budget (OMB) Circular A-130, in the DoD Directive 5400.11, “DoD Privacy Program,” May 8, 2007, and in the DoD 5400.11-R, “Department of Defense Privacy Program,” May 14, 2007. The contactor shall work with the government point of contact to identify Privacy Act System of Records that are maintained or operated for ASD (HA) Privacy Office. Completed System of Records Notice formats for the applicable systems should be sent to the ASD (HA) Privacy Office.

1.6.14.5.3 Personnel Security: The contractor shall comply with DoD Directive 8500.01E, “Information Assurance (IA),” October 24, 2002; DoD Instruction 8500.2, “Information Assurance (IA) Implementation,” February 6, 2003; DoD Directive 5400.11, “DoD Privacy Program,” DoD 6025.18-R, “DoD Health Information Privacy Regulation,” (January 2003); DoD 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.

· Immediately report to the Executive Director, Force Resiliency (EDFR) 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.

1.6.14.5.4 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 accurately 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, CO, or DoW Policy. Files will be made available to the CO, or the COR upon request. The automated data files are the property of the Government and will be turned over to the CO 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.

1.6.15 Organizational 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. The contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI 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 OCI.

1.6.16 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 15 calendar days phase-in period and during 30 calendar days phase-out period. During the phase-in period, the contractor shall become familiar 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.

1.6.16.1 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.

1.6.16.2 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 not defer any requirements or transfer such responsibility to the succeeding contractor before the end of the last performance period. As part of the phase-out, the contractor shall:

· Maintain all records for a minimum of 2 years, as required by HHS guidelines. The confidentiality of the information must be maintained.

· The contractor must continue to support donor access to records (5.4.1) and litigation package requests (5.4.2) until the end of the last performance period. USSF is responsible for any associated costs.

1.6.17 Monthly Invoice Reports: The contractor shall provide electronic (PDF format) copies of invoices a monthly basis and to the COR for audit review of charges. A copy of the signed monthly invoices will be provided electronically to the COR. 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, the invoices and receiving report for payment. The contractor shall invoice in accordance with the Wide Area Workflow (WAWF) invoicing instructions.

1.6.18 Quarterly Reports: For all MRO reviews, the contractor will provide quarterly reports no later than 30 calendar days after the end of each quarter. The report shall include the scheduling turn- around-time (TAT) (i.e., the percent of orders shipped within one (customer schedules) and three (contractor schedules) business days, and the percent of scheduling/processing completed within 24 hours of test request), the percent of negative results reported within 2 business days of receipt from the lab, and the percent of positive results reported within 5 business days of receipt from the lab. In addition, each quarter the contractor shall provide to the COR an inventory of blind proficiency urine specimen samples previously submitted to the contractor’s laboratory and notation of any discrepancies noted. Note: the COR may request to receive these reports on a more frequent basis to include monthly.

1.6.19 Annual Reports: The contractor shall provide an annual report no later than 30 calendar days after the end of each fiscal year. The annual report shall be in tabular format with the following information: (1) the number of USSF TDP MRO reviews conducted, the number reported as cancelled/invalid/substituted and the number of TDPs reported as drug positive by drug; and, (2) the number of USSF pre-employment reviews conducted, the number reported as cancel/invalid/substituted and the number of pre-employment reviews reported as drug positive by drug. Note: the COR may request to receive these reports on a more frequent basis to include monthly or quarterly.

1.6.19.1 The contractor will provide no later than 60 days after the end of each fiscal year an annual summary of the data.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. 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.

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

2.1.3. 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.

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

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

2.1.6. 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 people that are listed in the proposal.

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

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

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

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

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

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

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

3.2 Facilities: The Government will provide basic facilities such as workspace that includes a desk and chair while working in Government facilities. The Government may provide approved facilities for collection.

3.3 Utilities: The Government will provide electricity and water. The contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions that preclude the waste of utilities, which include turning off the water faucets or valves after using the required amount to accomplish required tasks.

3.4 Equipment: Other property, materials, supplies, or equipment is not anticipated to be Government furnished.

3.5 Materials: In the context of this contract, Government Furnished Information (GFI) shall be accessible via the contractor-provided, central database for this program, as specified in Section 5.1- Web Portal Support Services. Access to the system shall be provided by the contractor to the Government (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. Records include donor identification information and TDP drug test results which must be reviewed by the MRO. Final report/documentation must be accurately entered into the Contractor’s database and made available to designated, required government personnel.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall provide secure restricted access to records of drug results and associative personnel identifiers. The Contractor shall establish processes consistent with the Privacy Act of 1974, Public Law 104-191 ‘The Health Insurance Portability and Accountability Act (HIPAA)’, 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.

4.2 Secret Facility Clearance: Not Applicable

4.4. Equipment. The Contractor shall provide laptop computer and cell/work phone, and any other items that’s needed to support the requirements listed in the PWS.

4.5. Training. The Contractor shall provide training to ensure that all of its employees have been properly trained and are qualified to perform assigned tasks associated with civilian drug urinalysis collection, specimen handling, shipment, storage, and disposal requirements under this PWS in accordance with HHS directives and guidelines. 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.

4.6. Off-site Clinic and Collection Site Facilities: The Contractor will ensure that all clinics used for USSF pre-employment specimen collections meet the requirements of the HHS Federal Agency program as described in the HHS Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs, (effective October 1, 2017) as well as any future revisions to the HHS guidelines. Providing off-site clinic facilities will be the responsibility of the contractor. Collection site facilities must meet the following minimum HHS guidelines:

· Provide for donor privacy while he or she provides the urine specimen. An observed collection must only be performed when required by HHS guidelines.

· Provide a source of water for washing hands. The water source should be external to the restroom where urination occurs. If the only source of water available is inside the restroom, then collector must secure the water source before the collection and then restore the water source after the collection to allow the donor to wash their hands. Moist towelettes are an acceptable alternative.

· Have a clean surface for the collector to use as a work area.

· Have procedures or restrictions to prevent unauthorized access to the site during collection, unauthorized access to collection materials/supplies, donor access to items that could be used to adulterate or dilute the specimen, unauthorized access to the specimen after it is collected and unauthorized access to collection site records.

· Collector must maintain line-of-sight custody or provide for the secure storage of specimens from the time the specimen is collected until it is sealed in a shipping container prior to transfer to an express carrier or courier for shipment to the laboratory.

· The contractor performing under this PWS must comply with collection procedures and requirements in the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs. It is the Contractor’s responsibility to ensure compliance with the HHS Mandatory Guidelines in the collection process.

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.0. Basic Services. The contractor shall provide pre-employment Civilian Drug Free Workplace Collections and MRO Support Services based on the following tasks listed below. Specimen collection will include approximately 1,500 collections and all collections onsite or in a clinic.

Collection supplies, as identified in Technical Exhibit 6, and MRO support services will be required for approximately 1,500 pre-employment specimen collections, regardless of whether these specimens are collected by the contractor or by Government. As needed, the Government can exercise a time and materials option for up to 1,500 additional MRO services, collection services, and/or collection supplies (identified in Technical Exhibit 6).

5.1. TASK 1 - WEB PORTAL SUPPORT SERVICES:

5.1.1 The Contractor shall provide a secure website for the placement of drug results and test requests, locate and assign collection clinics for the performance of specimen collections; notify donors of instructions when appropriate; and print (remotely or onsite, if not using eCCF) and ship (CCFs to the applicable clinics and/or collectors. All web portals using eCCFs must meet all HHS guidelines and have requisite HHS authorizations to include secure transmission of the eCCF from the collection site to the FTDTL and to the MRO.

5.1.1.1. The Contractor will be granted access to Forensic Toxicology Drug Testing Laboratory (FTDTL) results portal via Common Access Card (CAC) only.

5.1.2 The Contractor shall provide and maintain a web portal that is secure, and requires CAC authentication and shall:

· Provide the USSF with the capability to schedule pre-employment collections, order pre-employment drug tests, and request collection supplies (e.g., HHS-approved forms (CCFs), bottles, and overnight shipping supplies).

· Provide the USSF secure access to their specific account sites for reports retrieval.

· Provide the USSF access to the eScreen eCCFs. Fort Meade FTDTL is only certified by HHS to use the eScreen eCCFs.

· Be able to electronically transfer all data fields on the eScreen eCCF to Fort Meade FTDTL.

5.2. TASK 2 – COLLECTION SUPPORT SERVICES:

5.2.1 The Contractor shall provide collection support services for CONUS and worldwide OCONUS as identified in Technical Exhibit 5 for urine collection in accordance with HHS guidelines and applicable DAF requirements. The Contractor shall provide for onsite and clinic site collections required under HHS guidelines and applicable USSF requirements. Clinic collection sites shall be no more than 25 miles from the donor’s address.

5.2.2 The Contractor shall facilitate collections for sites where the Contractor provides collection services and sites where they do not collect specimens shall include the ability to provide collection kits, overnight shipping supplies, and Federal forms (CCFs and eCCFs, if applicable), as required under HHS guidelines, for all collections. Applicant specimen collections, whether collected by the Contractor or not, shall be shipped overnight at the Contractor’s expense to the Fort Meade FTDTL for analysis.

5.2.3 Scheduling: The Contractor shall provide electronic capability to USSF for scheduling a specimen collection, in accordance with PWS Task Section 5.1. The Contractor will allow USSF to dictate whether on-site or clinic-based pre-employment collections are preferred for each scheduling event. The contractor must schedule the pre-employment collection within 24 hours of a request placed by USSF.

5.2.4 Collection Site: The contractor will ensure that all clinics used for USSF pre-employment specimen collection meet the requirements for the HHS Federal Agency program as described in the HHS Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs, (effective October 1, 2017) as well as any future revisions to the HHS guidelines. The cost of providing off-site clinic facilities will be borne by the contractor. The contractor must secure the collection site to prevent unauthorized access to specimens, collection supplies, and collection site records. A permanent site that is used solely for specimen collections must be secured at all times. At facilities that are not dedicated specimen collection sites, the area of the site used for specimen collections must be secured during the time a specimen is collected.

5.2.5 Federal Drug Testing CCF: The contractor shall provide forms approved (current and any future versions) by the Office of Management and Budget (OMB) as the Federal CCF for collecting urine specimens for the workplace drug testing programs. This includes the electronic CCF (eScreen eCCF). The contractor is responsible for providing Federal CCF forms and collection kits to the collection sites, whether the contractor performs the collections or not. The contractor shall coordinate form content (e.g., address information, specimen sequence, etc.) with the testing lab (Fort Meade Forensic Toxicology Drug Testing Laboratory). The contractor must ensure that forms are completed as described in the HHS guidelines. Forms may be electronic (eScreen eCCFs) and generated at the point of collection, provided the forms meet all current and future HHS and OMB requirements and submission of the same is coordinated with the testing laboratory to ensure that the eCCF system is the same as the laboratory system approved by HHS.

5.3. TASK 3 – MRO REVIEW AND REPORTING: The contractor shall provide MRO Review and Reporting Services that are in accordance with the HHS MRO Guidance Manual for Federal Workplace Drug Testing Programs published in 2020 and any updates or more recent versions.

5.3.1 Result Reporting Support: The contractor shall send the certified laboratory results through the secure web portal that is provided and maintained by the contractor. The contractor shall post final result reports and documentation to the respective military services and USSF via the web portal.

5.3.2. The MRO Review and Reporting Process: The contractor will follow current HHS Guidelines and subsequent amendments when reviewing and reporting results for regulated testing.

5.5 TASK 5 – MRO TESTING SERVICES SUPPORT:

5.5.1 Bottle B Testing: Donors may, upon written request through the contractor, USSF, AFMEDCOM, and DoW, request testing of bottle B at another HHS-certified laboratory. In accordance with HHS guidelines, the MRO will facilitate the transfer of the donor’s bottle B from the FTDTL to another HHS-certified laboratory for testing and provide the results back to the USSF, AFMEDCOM, and DoW.

5.6. TASK 6 – PROGRAM MANAGEMENT SUPPORT SERVICES:

5.6.1. The contractor Program Manager will be the ultimate contractor point of contact to address and resolve issues, concerns, and problems related to contractor performance.

5.6.2 Program Management responsibilities include: (1) ensuring that collection, MRO, and all other tasks are managed consistently with overall contract requirements, and (2) ensure timely and accurate submission of invoices and reports.

5.7. TASK 7 – OPTIONAL SUPPLIES AND MRO SUPPORT

5.7.1 The Government reserves the right to not exercise any of the following optional tasks or task areas listed below (5.7.2-5.7.5).

5.7.2 Optional Time and Material Task: Additional COLLECTION SUPPORT SERVICES:

The Contractor shall perform additional effort required in accordance with Task 5.2 and subtasks listed above for 5.2.

5.7.3 Optional Time and Material Task – Additional MRO REVIEW AND REPORTING:

The Contractor shall perform additional effort required in accordance with Task 5.3 and subtasks listed above for 5.3.

5.7.5 Optional Time and Material Task – Additional MRO TESTING SERVICES SUPPORT:

The Contractor shall perform additional effort required in accordance with Task 5.5 and subtasks listed above for 5.5

Part 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor must abide by all statutes, applicable regulations, publications, manuals, and federal policies, procedures.

6.1.1. The primary documents related to this PWS are:

· Medical Review Officer Manual for Federal Agency Drug Testing Programs (Revised January

· 2020)

· Federal Register 7920 /Volume 82, No. 228 (January 23, 2017)

· Model Plan for a Comprehensive Drug-Free Workplace Program

· Executive Order 12564—Drug Free Workplace (September 15, 1986)

· HHS Urine Specimen Collection Handbook for Federal agency Workplace Drug Testing Programs, (effective October 1, 2017).

· HHS Oral Fluid Specimen…