Attachment__6_Performance_Work_Statement.pdf

PERFORMANCE WORK STATEMENT (PWS)

Dated: 25 June 2019

Civilian Drug Free Workplace Collections and

Medical Review Officer Support Services

General Information

1. GENERAL: This is a non-personnel services contract to provide Civilian Drug Free Workplace

Collections and Medical Review Officer Support Services. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the

Government.

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 medical review (MRO) services. The 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.

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. Based upon the most recent year metrics and current testing rates (50% of TDPs), specimen collection will include approximately 67,000-108,000 collections: 45,000 – 53,000 on-site and 22,000 – 55,000 clinic. Facilitation of collections by non-contract collectors will constitute 67,000 – 108,000 collections. MRO services will include result evaluation of all

135,000-216,000 specimens, regardless of whether collected by the Contractor or not.

1.3 Objectives:

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

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

HHS guidelines.

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

c. Provide collection supplies (e.g., HHS-approved forms (CCFs), bottles, 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 drug testing results for review reporting, and documentation consistent with DoD and HHS regulations.

h. Provide statistical reports detailing the Services provided.

1.4 Scope: The scope of this requirement provides for all civilian drug testing services of TDPs and civilian applicants, as required, 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 urine collection using forensic procedures, providing collection supplies, the preparation of litigation packages, providing litigation support services/travel associated with expert witness testimony, and

Medical Review Officer (MRO) functions 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 services include:

(1) reviewing lab test results and specimen custody and control forms (CCFs) to verify forensic and scientific reliability; (2) conducting donor interviews (as required); (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 as needed.

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 one (1) Base Period of 12 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.

1.6.2 Quality Assurance: The Government intends to utilize a Quality Assurance Surveillance Plan

(QASP) to monitor the quality of the Contractor’s performance. Continuous contract oversight and the

QASP will ensure that the levels of services provided will be attained and maintained throughout the contract term. Further, the QASP provides the COR a documented set of standards to proactively address unacceptable or deficient performance, and provides verifiable input for the required Past Performance

Information Assessments. The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary. .

Inspection and acceptance of MRO reports, data input, deliverables and work performance shall be conducted in accordance with the criteria set forth in this contract. Government acceptance of satisfactory services provided by the Contractor is contingent upon meeting the terms and conditions of this contract.

The Government intends to conduct quarterly electronic program reviews on the progress, status and performance under this contract. However, the Contractor and its MROs are expected to meet all delivery and reporting deadlines or documentation turnaround times as specified within this PWS.

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

1.6.4 Hours of Operation: To ensure accessibility (when necessary) 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). An answering service or a direct phone or cell phone contact is acceptable 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.

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 PM will work 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 4-contains an example of locations where collections occurred in FY 2017. The locations cited does not imply that these are the only locations where collections may occur over the course of this contract.

Contractor personnel involved in on-site collections must be able to obtain, as required; building passes and meet any additional personnel security requirement for building access.

1.6.6 Type of Contract: The government will award a Firm Fixed Price with Time & Material Travel.

1.6.7 Security Requirements: On-site civilian collections conducted at several DoD Agencies may require the Contractor’s compliance with DoD Agency’s personnel security regulations.

1.6.8 Special Qualifications: All Contractor personnel are required to complete and sign a non-disclosure agreement that shall be submitted five (5) days after contract award. 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.

1.6.8.1 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. Non-disclosure agreement shall be signed by all contractor employees supporting this effort and forwarded to the Contracting Officer’s Representative (COR).

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 with regard to 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.

1.6.11.1 Program Manager (PM). The Contractor shall ensure that the PM possesses the skills, knowledge, training, and certification(s) required to satisfactorily perform all services required by the contract. The Program Manager must have a minimum of five (5) years’ experience in the HHS and DOT regulated environment, including strong working knowledge of policy regulations pertaining to employers, Medical Review Officers, laboratories, and collectors. The Program Manager must have 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.

1.6.11.1.1 The Program Manager must have executive-level management experience, leading multi-disciplined teams of technical developers, clinic network management personnel, compliance experts, account management teams, and various operational departments. The Program Manager must have senior level organizational project management experience, including requirement gathering, design, implementation, and ongoing program management. The PM will have overall authority for contract management, control and supervision of contract performance within the Contractors’ organization. This individual shall possess knowledge of applicable laws, codes, standards, directives, and criteria governing the operation of medical research, analysis, and reporting as related to Federal Drug Testing Programs and the role of MROs. In particular, the PM shall be an expert in a variety of organizations and requirements, including all applicable regulations promulgated by the HHS, DoD and applicable DoD Agency policies.

1.6.11.2 Medical Review Officer (MRO). The Contractor is responsible to ensure an adequate number of qualified MROs are on staff to provide the required level of forensic documentation review and interpretation. Each MRO shall be a licensed physician, M.D. (Doctor of Medicine) or D.O. (Doctor of

Osteopathic Medicine), who must pass an examination administered by an HHS-approved organization

(i.e., a nationally recognized entity that certifies MROs or a subspecialty board for physicians performing a review of Federal employee drug test results). HHS publishes an annual list of approved organizations in the Federal Register. The MRO must be knowledgeable about the following:

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

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

82 FR Part 7920-7970 (October 1, 2017) Mandatory Guidelines for Federal Workplace

Drug Testing Programs

1.6.11.2.1 The MRO shall be knowledgeable about what tests were used to generate the specimen results and should understand the general scientific principles of the technologies. 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). The following restrictions apply to an

MRO:

The MRO must not be an employee or agent of, or have any financial interest in, the laboratory for which the MRO is reviewing drug testing results, and

The MRO must not derive any financial benefit by having an agency use a specific drug testing laboratory or have any agreement with the laboratory that may be construed as a potential conflict of interest.

1.6.11.2.2 Licensure and Certifications

The Contractor shall ensure and provide to the COR proof that all MROs/providers maintain at least minimum amounts of malpractice/medical liability insurance as required by state, commonwealth, district or territory licensing requirements for the specific MRO location in which they are providing contract 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.

1.6.11.3 During the first 90 calendar days of performance, the Contractor shall make no substitutions of key personnel without the approval of the Contracting Officer, unless illness, death, or termination of employment necessitates the substitution. The Contractor shall notify the Contracting Officer as soon as possible after the occurrence of any of these events and provide the information required below.

1.6.11.3.1 After the initial 90 calendar day period, the Contractor may propose a substitution. The

Contractor shall notify the Contracting Officer 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. The Contractor shall, prior to making any substitution permanent, demonstrate to the satisfaction of the Contracting Officer, 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.

1.6.12 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 in the performance of this service.

1.6.13 Contractor Travel: In accordance with FAR 31.205-46, Travel, the contractor may be required to perform the services specified in the PWS. Travel within the NCR or in local areas in the CONUS and

OCONUS (i.e. See Technical Exhibit 4) to perform these services, as listed Part 5 – Specific Tasks, is not separately priced. Travel expenses may be incurred as related to collections at sites not specified in

Technical Exhibit 4, periodic training, and occasional administrative meetings. The Contractor shall provide a written request for travel to the COR prior to finalizing any travel arrangements only when travel is related to expert witness testimony, collections at sites not specified in Technical Exhibit 4, periodic training, and occasional administrative meetings. Requests for travel shall include the name of the person(s) traveling, travel destination, dates of travel, mode of transportation, and estimated costs for travel. All travel must be pre-approved in writing by the COR and prior to purchase of any tickets and commencement of travel. The Contractor shall be reimbursed for actual allowable, allocable, and reasonable travel cost incurred during performance efforts in accordance with FAR 31.205-46. Travel shall be addressed as a

Time & Materials item. The Government has established a Not-To-Exceed Cost for Traveling for the base period and each option period that the contractor will bill against once receiving approval from the COR under the Time and Material (T&M) CLIN. Local travel within the NCR and travel to/from sites specified in Technical Exhibit 4 shall not be reimbursed.

1.6.13.1 All travel within the National Capital Region (NCR) and to/from sites specified in Technical

Exhibit 4 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 4 for any CLIN or SUBCLIN under this contract, except as allowed by Section 1.6.13 for periodic training and occasional administrative meetings.

1.6.13.2 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. Whenever possible, 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).

1.6.14 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. (When preparing its proposal, the offeror may choose to build the expected costs resulting from no-shows into its proposed unit price for collections.)

1.6.14.1On 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. (When preparing its proposal, the offeror may choose to build the expected costs resulting from cancellations into its proposed unit price for collections.)

1.6.15 Data Use Agreement: A Data Use Agreement (DUA) is a contractual agreement between outside entities and the DOD to ensure that PHI or 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

1.6.16 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.

1.6.17. 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.

1.6.17.1 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).

1.6.17.2 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.

1.6.17.3 Quarterly Reports: For all MRO reviews, the Contractor will provide no later than 30 calendar days after the end each quarter a report of the scheduling turn- around-time (TAT), 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.

1.6.17.4 Annual Reports: The Contractor shall provide no later than 30 calendar days after the end of each fiscal year, in tabular format, 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.

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

1.6.17.4.2 In addition the contractor shall provide to the COR an annual inventory of blind proficiency urine specimen samples previously submitted to the Contractor’s laboratory and notation of any discrepancies noted.

1.6.18. Security: 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:

1.6.18.1 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.

1.6.18.2 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.

1.6.18.3 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 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.

1.6.18.4 Files Security

In accordance with HHS guidelines, the 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). 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. A password protection procedure shall be used for all donor and research records.

1.6.19 Training: The Contractor shall provide training, as necessary 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. As appropriate, contractor personnel will be trained 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 other information assurance and security regulations of the DoD.

1.6.20 Phase In 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 10 calendar days phase-in. 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.

1.6.20.1.Phase-in Plan: 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.

1.6.21 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 5.

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

ASD (HA) Assistant Secretary of Defense for Health Affairs

CFR Code of Federal Regulations

CONUS Continental United States

COR Contracting Officer Representative

CPARS Contractor Performance Assessment Reporting Plan

CCF Custody Control Form

DoD Department of Defense

DoDACC Department of Defense Activity Address Code HHS Department of Health and Human

Services DOI Department of the Interior

DASD(R) Deputy Assistant Secretary of Defense for Readiness

DDRP Drug Demand Reduction Program

FAR Federal Acquisition Regulations

FR Federal Regulations

FTDTL Forensic Toxicology Drug Testing Laboratory GFE Government Furnished Equipment

GFF Government Furnished Facilities

GFI Government Furnished Information

GFP Government Furnished Property

HIPAA Health Information Portability and Accountability Act

ID Identification

KO Contracting Officer

LPO Legal Process Outsourcing

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

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

HHS Substance Abuse and Mental Health Administration

SSN Social Security Number

TAT Turn-Around-Time

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 while working in Government facilities.

3.2 Facilities: Basic facilities such as work space will be provided while working in Government facilities.

3.3 Equipment: The Government may provide approved facilities for collection. Other property, materials, supplies, or equipment is not anticipated to be Government furnished. 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. 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 Collection Site Facilities: 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-site 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.

4.2.1 On-Site Collections: The Contractor shall provide on-site collections services in support of the DoD Federal agencies that require trained collectors to support their drug demand reduction program. The Federal agency will provide collection facilities to support the collection process as stated above (Collection Site Facilities). The agency is responsible for assuring that the facilities meet the minimum guidelines required by HHS. The Contractor is responsible for assuring that the collectors meet the requirements stated in section 3.2.2.

4.2.2 Worldwide Collection Capability: The Contractor shall have the capability to provide collection services at sites worldwide. Examples of sites where collections occurred in FY 2017 are specified in Technical Exhibit 4. The Contractor shall certify that all partnering clinics meet the minimum guidelines specified above.

4.3. Collector Qualifications:

All collectors 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.

4.4 Equipment: NA

PART 5

SPECIFIC TASKS

5. SPECIFIC TASKS:

5.0 The contractor shall provide Civilian Drug Free Workplace Collections and Medical Review Officer

Support Services based on the following tasks listed below. The following section specifies the

Performance Objectives and Performance Elements for the contract.

5.1. TASK 1 - WEB PORTAL SUPPORT SERVICES:

5.1.1 The objective for the Test Scheduling and Order Fulfillment Services task is to 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 and ship custody and control forms (CCFs) to the clinics and or collectors. The contractor-required performance standards consists of two categories: 1) Customer schedules (agency notifies the donor) orders shipped, on average, in less than one (1) business day and 2) Contractor schedules (Contractor notifies the donor) orders shipped, on average, in less than 3.0 days.

5.1.1.1. The Contractor may be granted access to Forensic Toxicology Drug Testing Laboratory (FTDTL) results portal via Common Access Card (CAC) only. The Contractor is permitted to login via a DOD

CAC Card to the portal, and download data files as needed. The Contractor is responsible for obtaining and maintaining CAC card(s). The government will assist the vendors with getting CAC card access.

5.1.2 The Contractor shall provide and maintain a web portal that is secure and password restricted. The web portal shall:

Provide the Military Services and DoD Agencies with the capability to schedule collections, order drug tests, and request collection supplies (e.g., HHS-approved forms (CCFs), bottles, and overnight shipping supplies).

Provide the Military Services and DoD Agencies secure access to their specific account sites for reports retrieval.

5.2. TASK 2 – COLLECTION SUPPORT SERVICES:

5.2.1 The Contractor shall provide collection capability for CONUS and worldwide OCONUS as identified in Technical Exhibit 4 for urine collection in accordance with HHS guidelines and applicable Agency requirements. The Contractor shall provide for onsite and clinic site collections as required under HHS guidelines and applicable Agency requirements.

5.2.2 The Contractor shall facilitate collections for sites where the Contractor provides collection services and sites where they do not. Facilitation of collections at sites where the contractor does not collect specimens shall include the ability to provide collection kits, overnight shipping supplies, and Federal forms (CCFs), as required under HHS guidelines, for all collections. All civilian TDP or applicant specimen collections, whether collected by the Contractor or not, shall be shipped overnight at the

Contractor’s expense to the Fort Meade Forensic Toxicology Drug Testing Laboratory (FTDTL) for analysis.

5.2.3 For continuity of service, the Contractor is required to assign a cadre of individuals to Federal

Agencies conducting frequent on-site collections (e.g. 20-24 collection events per month) throughout the course of the year. Each collection event may encompass a full 8 hour day. Consistency in the assignment of individuals as collectors to Agencies permits the collector familiarity with the Federal Agency on-site collection facilities. The Contractor is to assign on a part time or full time basis individual collectors to

Federal Agencies where weekly or bi-weekly collections encompass a full 8 hour day. The Agency where this requirement is anticipated is Washington Headquarters Service, Arlington, VA;.

5.2.4 Scheduling

The MRO shall provide electronic capability to the DoD Agencies for scheduling a specimen collection, per Section 5.1. DoD Agencies shall be allowed to dictate whether on-site or clinic-based collections are preferred for each scheduling event. Collection must be scheduled by the contractor within 24 hours of a request placed by the Government (i.e. Military Service or DoD Agencies)

5.2.5 Collection Site

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. 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.

5.2.6. Federal Drug Testing Custody and Control Form (CCF): The contractor shall provide forms approved (current and any future versions) by the Office of Management and Budget as the Federal CCF for collecting urine specimens for the workplace drug testing programs.