A23 Attch1 - Performance Work Statement - Draft 11-22-24.pdf

PERFORMANCE WORK STATEMENT (PWS)

Office of the Undersecretary of Defense for Personnel & Readiness (OUSD(P&R) Office of Drug Demand Reduction (ODDR)

Civilian Drug Free Workplace Collections and Medical Review Officer (MRO) Support Services

November 15, 2024

Part 1

General Information

1. GENERAL: This is a non-personnel services contract to provide Civilian Drug Free Workplace Collections and Medical Review Officer (MRO) Support Services. 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.

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 Civilian Drug Free Workplace Collections and Medical Review Officer 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.

1.2 Background: In the late 1980’s, Federal Agencies were required to begin drug testing their respective civilian workforce in Testing Designated Positions (TDPs) based on Department of Health and Human Services (HHS) guidelines. Pursuant to 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 under DoD Instruction 1010.09, “DoD Civilian Employee Drug-Free Workplace Program” (June 22, 2012).

1.2.1 The requirement to conduct civilian drug testing was placed on the DoD agencies and Military Services, which, in turn, developed separate programs governed by separate DoD Directives. In an effort to meet the need to conduct drug testing under HHS guidelines, the Department of Interior (DoI) 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 Department of Defense laboratory certified by HHS.

1.2.2 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 DoD Agencies and Military Services, per guidelines set forth by HHS. 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 DoD laboratory in accordance with HHS guidelines.

1.2.3 The Drug Testing Services under this contract extend to a growing population of Government employees employed by the DoD Agencies and Military Services. The projected annual testable TDP population is based upon a number of variables to include civilian testing rates, number of applicants to these positions (who also require pre-employment testing), additional TDP job titles, and Federal workforce expansion or decrements based on Congressional actions. Some DoD agencies have certified collectors and only require MRO support services and collection supplies. These services are termed self-collections and represent approximately 53% of total DoD collections. The remaining 47% of collections are contract-supported collections conducted on-site or at a clinic. Most random contract-supported collections are conducted on-site at the agency while pre-employment and remote workforce testing are typically accomplished at a clinic within 25 miles of the donor’s home address. Contract-supported collections also require MRO services support and collection supplies in addition to collection and scheduling support services. Based upon the most recent year metrics and current testing rates (random testing of 50% of TDPs annually and pre-employment testing for all TDPs), specimen collection will include approximately 180,000 collections, where: 85,000 of these collections are onsite or in a clinic. Self-collections or facilitation of collections by Government collectors will constitute approximately 95,000 collections.

Collection supplies, as identified in Technical Exhibit 6, and MRO support services will be required for approximately 180,000 specimen collections, regardless of whether these specimens are collected by the contractor or by Government. Numbers are estimates and based on historical data. As needed, the Government can exercise a time and materials option for up to 60,000 additional MRO services, collection services, and/or collection supplies (identified in Technical Exhibit 6). Less than 200 annual total collections are expected to be oral fluid.

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 (or oral fluid collection when indicated) capabilities consistent with HHS guidelines.

b. Provide on-site (i.e., in government facilities) forensic urine collection (or oral fluid collection when indicated) capabilities consistent with HHS guidelines.

c. Provide collection supplies (e.g., HHS-approved forms (eScreen eCCF and CCFs), bottles (or oral fluid collection devices when indicated), and overnight shipping supplies) for all collection sites, even where the contractor does not conduct collections.

d. Partner with DoD Agencies to enhance compliance with the DoD Civilian Employee Drug-Free Workplace Program requirements (DoD Instruction 1010.09).

e. 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.

f. Provide Medical Review Officer (MRO) Services of urinalysis (or oral fluid when indicated) drug testing results for review reporting, and documentation consistent with DoD and HHS regulations.

g. Provide statistical reports detailing the Services provided.

1.4 Scope: The scope of this requirement provides for all required civilian drug testing services of TDPs and civilian applicants, associated with the Military Services and DoD Agencies. The civilian drug testing under this PWS includes support services associated with off-site clinic and Federal Agency on-site specimen collection using forensic procedures, providing collection supplies, the preparation of litigation packages, litigation support services/, and Medical Review Officer (MRO) support for all DoD Civilian TDPs and applicants requiring drug tests. The MRO serves as the common point of contact between all parties involved in a drug test (i.e., the donor, the collector, the laboratory, and the Federal Agency's 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/Federal Agency;

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

(6) providing litigation support and testimony.

The contractor must demonstrate the 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 15 days, one (1) base period of 9 months and four (4) 12-month option periods.

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 KO 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 his 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:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day Inauguration Day (January 2025)

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 Standard Time (EST). 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.

1.6.4.1 For emergency requests for urinalysis collections worldwide (e.g., reasonable suspicion, probable cause, post-accident and unsafe practice testing, and any other reasons deemed necessary by the Service or Agency DPM) the contractor must be able to facilitate that collections shall be completed in accordance with HHS regulations. This service shall be available 24 hours per day, 7 days per week, and 365 days per year, to include leap year days.

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 occurred in FY 2023. 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 unexpected supplies and support.

1.6.7 Security Requirements: The contractor shall have a Secret facility clearance and maintain the level for the life of the contract. . Contractor personnel performing work under this contract must have a SECRET clearance level at and must maintain the level of security required for the life of the contract. The security requirements are in accordance with the attached DD254. On-site civilian collections conducted at several DoD Agencies will require the contractor’s compliance with DoD Agency’s personnel security regulations. Contractor personnel performing on-site collections must be able to obtain building/installation passes and meet any additional personnel security requirement for building/installation access.

1.6.8 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. Medical Review Officer (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.

c. Permanent Onsite Collector: A collector is the person who instructs and assists donors at a collection site and receives the specimen provided by the donor. The volume of collections at WHS necessitates Tra full-time onsite certified collector.

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

1.6.9 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.

1.6.10 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.

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

TASK KEY POSITION # OF FTES QUALIFICATIONS

5.1, 5.2, 5.6 Program Manager (PM) 1 FTE Security Requirement: Secret

Clearance

Education: Bachelor’s Degree

Minimum Qualifications:

One (1) year of executive level management experience leading multi-disciplined teams of technical developers, clinic network management personnel, compliance experts, account management teams, and various operational department.

Minimum of five (5) years of experience in the HHS and Department of Transportation (DOT) regulated environment including knowledge of policy regulations pertaining to federal employers, MRO services, laboratories, and collectors.

Minimum of five (5) years of operational experience with all aspects of the drug testing, resource and regulatory requirements including expertise in the management of clinic and onsite collector networks, laboratory testing and reporting procedures, compliance and medical review responsibilities, and software configuration to meet customer requirements.

Highly Preferred Qualifications:

Minimum of one (1) year of experience managing Federal Drug Free Workplace Programs to include collection, MRO, and reporting portal requirements and logistics.

5.1, 5.3, 5.4, 5.5

Medical Review Officer

1 FTE Security Requirement: Secret Clearance

Education: M.D. (Doctor of Medicine) or D.O. (Doctor of Osteopathic Medicine)

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

5.2 Permanent Onsite

Collector

1 FTE Security Requirement: Secret Clearance

Education: High school degree or higher

Minimum Qualifications:

Trained and certified for

Federal Workplace Drug Testing as a collector and observer.

Highly Preferred Qualifications:

One (1) year experience as a collector and observer for Federal Workplace Drug Testing

1.6.11.1 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.

1.6.11.2 After the initial 90 calendar day period, the contractor may propose a substitution. The Contractor shall notify the Contracting Officer and COR in writing of any proposed substitution at least thirty (30) days in advance of the proposed substitution. The contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer and COR. The contractor shall, prior to making any substitution permanent, demonstrate to the satisfaction of the Contracting Officer and COR, that the qualifications of the proposed substitute personnel is equal to or better than the qualifications of the personnel originally identified for the position. The Contracting officer will notify the contractor within 15 calendar days after receipt of all required information of the decision on proposed substitutions.

1.6.11.3 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.

1.6.12 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. Contractor personnel will be required to obtain, use, and display a Common Access Card (CAC) in the performance of this service.

1.6.13 Contractor Travel: All travel within the National Capital Region (NCR) and to/from sites specified in Technical Exhibit 5 is included in the price of this contract. The contractor shall NOT bill the Government for travel related expenses within the NCR or sites specified in Technical Exhibit 5 for any CLIN under this contract.

1.6.13.1 Travel Arrangements for Expert Witness testimony are not the responsibility of the contractor.

Costs of all associative travel, professional fees, transportation, meals, lodging, and incidentals are the responsibility of the Military Service or DoD Agency authority requesting Expert Witness testimony.

Telephonic testimony is encouraged in lieu of on-site Expert Witness testimony. Arrangements for Expert Witness support services, to include contingency fees, are the fiscal responsibility of requesting Military Service or DoD Agency and the contractor’s point of contact. Submission of travel vouchers for reimbursement of Expert Witness expenses is filed with the requesting Military Service or DoD Agency.

Costs for travel shall be billed and reimbursed in accordance with the Federal Travel Regulation (FTR), regulatory implementation of Public Law 99-234, and FAR 31.205-46 Travel Costs (subject to local policy & procedures; may reference FAR).

Travel arrangements for expert witness testimony will not be reimbursed under this contract.

1.6.14 Other Direct Costs: There are no other direct costs applicable to this contract. 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 Time and Material (T&M) CLIN.

1.6.14.1 Cancellations and No-Shows: It is not unusual for some government personnel scheduled for drug testing to fail to show up to the collection site. The Government estimates that during each period of performance, a total of 1,000 personnel will fail to show up for their scheduled drug test. This contract does not provide a mechanism for the contractor to bill the government for no-shows.

On occasion, the government will cancel a collection with less than twenty-four hours’ notice provided to the contractor. The Government estimates that during each period of performance there will be ten collection cancellations with less within twenty-four hours’ notice. This contract does not provide a mechanism for the contractor to bill the government for cancellations, including cancellations that occur with less than twenty-four hours’ notice.

Therefore, the Government will not provide payment for cancellations and no-shows.

1.6.15 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).

1.6.15.1 Data Use Agreement: A Data Use Agreement (DUA) is a contractual agreement between outside entities and the DOD 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-DoD-organization, or non-DoD 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 DoD 6025.18- R, “DoD 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.

1.6.15.2 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 DoD 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.

1.6.15.3 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.

1.6.15.4 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.

1.6.15.5 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:

1.6.15.5.1 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.

1.6.15.5.2 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.

1.6.15.5.3 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 DoD information and data as related to this requirement.

1.6.15.5.4 Files Security: All non-DoD (vendor) information systems that process, store, or transmit DoD 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 DoD 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 back up 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 in accordance with

1.6.16 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.

1.6.17 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.

1.6.17.1 The contractor shall submit a detailed phase-in plan to include start-up activities that may be required to transition to full operational capability upon conclusion of the transition period. The contractor 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;

• Provide a timeline for completion; and

• Identify associated risks and issues and risk mitigation strategies.

1.6.17.2 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 for avoiding responsibility 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) after the end of the last performance period. The requesting agency is responsible for any associated costs.

1.6.18 Monthly Invoice Reports: The contractor shall provide electronic (PDF format) copies of invoices by Military Service and DoD Agency on a monthly basis to each respective Military Service and DoD Agency and to the COR for audit review of charges. A copy of the Services and Agencies 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 Services’ and Agencies invoices and receiving report for payment. The contractor shall invoice in accordance with the Wide Area Workflow (WAWF) invoicing instructions.

1.6.19 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. The contractor will also provide the overall fatal flaw rate, the number of responses to legal authority’s request for expert witness testimony replied within 3 working days, the number of litigation packages delivered to the legal authority within 3 working days, and all retest related documentation delivered to the laboratory within 3 working days. 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 received these reports on a more frequent basis to include monthly.

1.6.20 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 by Military Service or DoD Agency: (1) the number of Military Service or DoD Agency 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 Military Service and DoD Agency 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.

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

1.6.20.2 In addition, the contractor shall provide to the COR an annual inventory of blind proficiency urine (or oral fluid when indicated) specimen samples previously submitted to the Contractor’s laboratory and notation of any discrepancies noted.

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. 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 persons 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:

AAMRO American Association of Medical Review Officers ACOR Alternate Contracting Officer's Representative AFARS Army Federal Acquisition Regulation Supplement 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 DASD(R) Deputy Assistant Secretary of Defense for Readiness 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 DMDC Defense Manpower Data Center DOD Department of Defense eCCF eScreen Electronic Custody and Control Form EDFR Executive Director, Force Resiliency 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 HHS Department of Health and Human Services KO Contracting Officer MD Doctor of Medicine MFR Memorandum for Record MRO Medical Review Officer MS Microsoft MSPB Merit System Protection Board NLCP National Laboratory Certification Program OCONUS Outside the Continental United States ODC Other Direct Costs 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 PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program PDF Portable Document Format PHI Protected Health Information PL Public Law PM Program Manager PWS Performance Work Statement QASP Quality Assurance Surveillance Plan QCP Quality Control Plan SSN Social Security Number TAT Turn-Around-Time TE Technical Exhibit TDP Testing Designated Position WAWF-RA Wide Area Work Flow – Receiving and Acceptance

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 DoD Directives or Instructions. Access to records and data files shall also be accessible to designated DoD Drug Demand Reduction Program (DDRP) management personnel.

4.2 Secret Facility Clearance: The contractor shall have a Secret facility clearance and maintain the level for the life of the contract. Contractor personnel performing work under this contract must have a SECRET clearance level at and must maintain the level of security required for the life of the contract. The security requirements are in accordance with the attached DD254. On-site civilian collections conducted at several DoD Agencies will require the contractor’s compliance with DoD Agency’s personnel security regulations.

Contractor personnel performing on-site collections must be able to obtain building/installation passes and meet any additional personnel security requirement for building/installation access. 4.3. Materials. The Contractor shall provide access to Government Furnished Information (GFI) 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 throughout the life of this contract. 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.

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. Supplies. The contractor shall provide collection supplies which will include a kit that consists of bottles, chains of custody forms, mailing supplies, and shipping costs, as identified in Technical Exhibit 6.

4.6. 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 DoD information assurance and security regulations.

4.7. Off-site Clinic and Collection Site Facilities: The Contractor will ensure that all clinics used for DoD 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.