MRO_PWS_Final.pdf

MRO Attachment 2

PERFORMANCE WORK STATEMENT

MEDICAL REVIEW OFFICER (MRO) AND URINE COLLECTION SUPPORT SERVICES

INTRODUCTION

1.1. BACKGROUND

In the late 1980’s, DOD Agencies were required to begin drug testing their respective civilian workforce based on Department of Health and Human Services (DHHS) 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)

The requirement to conduct specimen collection, laboratory analysis and Medical Review Officer (MRO) support was placed on the DoD agencies. The Military Services and DoD Agencies developed separate programs governed by separate DoD Directives. In an effort to meet the needs of the DoD Agencies to conduct drug testing under Department of Health and Human Services (DHHS) guidelines, the Department of Interior (DoI) established a drug testing services contract through its National Business Center. Drug Testing Services include:

Specimen Collection, Laboratory Analysis, and Medical Review Services.

In 2001, the Fort Meade Forensic Toxicology Drug Testing Laboratory (FTDTL) completed the DHHS National Laboratory Certification Program (NLCP). The FTDTL incrementally accepted DOD civilian testing designated position (TDP) specimen submissions; and, as of October 2007, the transition from civilian contract laboratories to a single DOD laboratory with centralized civilian specimen data tracking was completed. Subsequently, the centralization of these services resulted in: (1) better control and improved oversight of the civilian testing program, (2) lower laboratory costs, and (3) the exploration of other measures to reduce cost and enhance oversight such as centralizing MRO services.

The MRO services under this contract would extend to a growing population of Government employees consisting of approximately 185,000 DoD TDP personnel 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, additional TDP job titles, and Federal workforce expansion or decrements based on Congressional actions. Based upon the most recent year metrics, the collection services would approximate 45,000 – 53,000 On-site collections, 22,000 – 55,000 Clinic collections, and 145,000 – 185,000 MRO drug test result evaluations. The variance is due to potential addition of new TDP hires or increases in requested services due to additional Agency and Military Service participation in the contract.

Conducting the final review of drug testing results is an essential component of any drug testing program. Under the DHHS 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. OBJECTIVES

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

• Provide access to a worldwide system of clinics with forensic urine collection capabilities consistent with SAMHSA guidelines.

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

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

• Provide Medical Review Officer (MRO) Services of urinalysis drug testing results for review reporting, and documentation consistent with DOD and SAMHSA regulations.

1.3. SCOPE

The scope of this requirement provides for all civilian drug testing services of TDP positions and civilian applicants, as required, associated with the Military Services and DOD Agencies.

The civilian drug testing under this PWS include support services associated with off-site and Federal Agency on-site clinic urine collection using forensic procedures, the preparation of litigation packages, provide litigation support services/travel associated with expert witness testimony, and Medical Review Officer (MRO) functions for all DoD Civilian TDPs. 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 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 a dynamic work environment such as schedule changes, or interruptions resulting from weather or government shutdown.

GENERAL REQUIREMENTS

This section describes the general requirements for this effort. The following sub-sections provide details of various considerations.

1.4. NON-PERSONAL SERVICES

The services and performance required under this contract are determined to be not inherently governmental. The contractor shall not perform or give the appearance of performing inherently governmental functions as described in FAR Part 2 and Subpart 7.5, defined by Far Section

37.101 and further described at FAR Subpart 37.4, ‘Non-personal Health Care Services’, and all applicable DoD policy. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. All contractor personnel shall identify themselves as contracted support personnel in all forms of communication with all entities with whom Department of Defense (DOD) Civilian Employee

Drug Testing Program, Office of Deputy Assistant Secretary of Defense for Readiness (DASD(R)) has business dealings. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer immediately.

1.5. BUSINESS RELATIONS

The contractor shall successfully integrate and coordinate all activity needed to execute the requirements specified herein. The contractor shall manage the timeliness, completeness, and quality of the contract deliverables. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of all contractor personnel (including subcontractors). The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

1.6. CONTRACT MANAGEMENT

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to this PWS. The contractor must maintain effective communication between the contractor's corporate offices and the Director, Drug Testing and Program Policy and the respective Federal Agencies and Military Services Drug Program Offices.

The contractor shall establish processes and assign appropriate resources to effectively administer this contract. The Contracting Agent will not dictate how the contractor will efficiently and effectively execute the requirements of the solicitation. It is the responsibility of the contractor to consider establishment of subcontractor relationships necessary to execute the program; and, as necessary establish contacts with the DoD Agencies, U.S. Military Commands, U.S. Embassies or Consulates throughout the world to provide for secure collection of specimens at remote site locations or on an emergency basis. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and Contractor personnel assigned to support this contract. The contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on this requirement.

The Contractor shall provide contract administration to ensure that tasks are performed efficiently, accurately, on-time, and in compliance with the requirements of this contract. Specifically, the Contractor shall designate a single Program Manager (PM) to oversee this contract. The PM ensures that MRO personnel and resources are fully integrated into the performance of required tasks, reporting and documentation of MRO evaluations into the contractor’s central database. The Contractor shall also designate an alternate PM who is capable of handling all contract management tasks and responsibilities in the PM’s absence.

The Government will identify a Contracting Officer’s Representative (COR) who will be delegated by the Contracting Officer (KO) to manage specific task-related technical, functional, and oversight responsibilities. In the COR capacity, the individual will serve as the Government’s primary technical point of contact for all task-related activities and issues. The COR will review contractor performance and deliverables, and will receive and accept all Service and Agency approved contractor invoices.

1.7. SUBCONTRACT MANAGEMENT

The contractor shall be responsible for any subcontract management necessary to integrate work performed on this PWS and shall be responsible and accountable for subcontractor performance on this PWS. The prime contractor will manage work distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations. Contractors may add subcontractors to their team after notification to the Contracting Officer and Contracting Officer Representative (COR).

1.8. CONTRACTOR PERSONNEL, DISCIPLINES, AND SPECIALTIES

An integral part of successful performance under this contract is not only the production of quality products described in Section 3.0, but the responsiveness of contractor personnel in the day-to-day output of work products. While the end product or deliverable is vital to successful performance, day-to-day oversight also includes client interaction and responsiveness.

Accordingly, the contractor is required to proactively maintain assigned tasks, and be responsive to all entities with professional business dealings related to the assigned tasks.

The Contractor must at all times maintain an adequate work force for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

The work to be performed herein is considered bona fide professional labor and is exempt from the Fair Labor Standards Act (FLSA).

The Contractor shall successfully integrate and coordinate all activities needed to execute the requirements specified in this PWS. The Contractor shall manage the timeliness, completeness, and quality of problem identification. The Contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The Contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

The Government expects the Contractor to provide knowledgeable SAMHSA certified MRO personnel who maintain familiarity with current and emergent drug trends and journal publications applicable to the performance of services in the final review, interpretation and documentation of all TDP and applicant test results as required under the Federal Workplace Drug Testing Program and SAMHSA guidelines. Additionally, personnel should be dedicated to the goals of prevention, detection and control of drug abuse by Federal employed TDP personnel and applicants for Federal Agency employment.

The Contractor shall not employ any potential employee whose background indicates an unacceptable threat to life, health and safety of staff, and/or Government information.

Contractor employees shall have all required qualifications and, if applicable, shall have the professional certifications and be licensed and insured as required by the federal, state, or local Government agencies needed to meet and maintain appropriate federal, state, and local medical, research, OSHA, environmental requirements or laws and standards. On-site civilian collections conducted at several DOD Agencies may require the Contractor’s compliance with DOD Agency’s personnel security regulations.

1.9. 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 and shipment under this PWS in accordance with DHHS and SAMHSA 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.

1.10. TRAVEL

Travel may be required to perform the services specified in the PWS. Travel expenses may be incurred as related to expert witness testimony, periodic training, and occasional administrative meetings.

Arrangements for Expert Witness testimony and 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 Joint Travel Regulation (JTR), regulatory implementation of Public Law 99-234, and FAR 31.205-46 Travel Costs (subject to local policy & procedures; may reference FAR).

1.11. LOCATION

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. Attachment 1 contains an example of locations where collections occurred in FY 2012. The site 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.

1.12. HOURS OF WORK AND COMMUNICATION

To ensure accessibility (when necessary) by appropriate Government representatives, the 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, reasonable 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 SAMHSA regulations. This service shall be available 24 hours per day, 7 days per week, and 365 days per year, to include leap year days.

2. PERFORMANCE REQUIREMENTS

This section of the PWS outlines the tasks the Contractor shall perform under this contract. The following section specifies the Performance Objectives and Performance Elements for the contract.

The tasks include:

2.1. TASK 1 – The Contractor shall maintain a functional and accessible web portal as described in the PWS.

2.2. TASK 2 - The Contractor shall provide services related to civilian urinalysis specimen collection in accordance with DHHS and SAMHSA guidelines and regulations as described in the PWS.

2.3. TASK 3 – The Contractor shall conduct MRO review, reporting and file management of drug laboratory results in accordance with DHHS and SAMHSA guidelines and regulations as described in the PWS.

2.4. TASK 4 - The Contractor shall provide services related to litigation support and expert witness testimony, as needed, as described in the PWS.

TASK 1 - WEB PORTAL

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 to the clinics. 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.

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 clinic collections and order drug tests.

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

• Be compatible, from both a technical and security perspective, with the Government’s lab results portal at Fort Meade that allows the Contractor to obtain relevant civilian test results for MRO review. Fort Meade utilizes the DoD Laboratory Information Management System (LIMS) for data management (i.e. tracking specimen receipts, testing status, etc), and reports drug test results via a lab results portal. The Contractor may be granted access to Fort Meade’s lab results portal via one of the following secure mechanisms:

i. The only rout of access for the web portal is through a CAC card access. 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.

TASK 2 - COLLECTION SERVICES

The Contractor shall provide clinic collection capability for CONUS and worldwide OCONUS urine collection in accordance with SAMHSA guidelines and applicable Agency requirements. The Contractor shall provide for on-site and remote site collections as required under SAMHSA guidelines and applicable Agency requirements. The Contractor shall use collection kits and Federal forms as required under SAMHSA guidelines and all civilian TDP or applicant specimen collections shall be forwarded to the Forensic Toxicology Drug Testing Laboratory, 2490 Wilson Street, Fort George G. Meade, and Maryland 20755. The Fort Meade Laboratory will provide the contractor with collection forms and pre-paid mailers for submission of specimens to the Laboratory.

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 encouraged 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 Agencies where this requirement is anticipated are Washington Headquarters Service, Arlington, VA; Defense Security Services, Alexandria, VA; and the Defense Information Systems Agency, Fort Meade, MD.

2.2.1 Scheduling

The MRO shall provide electronic capability to the DOD Agencies for scheduling a specimen collection. The MRO will ensure that all clinics used for DOD specimen collection meet the requirements for the DHHS Federal Agency program as described in the SAMHSA Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs, (effective October 1, 2010) as well as any future revisions to the SAMHSA guidelines.

2.2.2 Collector Qualifications

All collectors under this PWS must comply with collection procedures and requirements in the DHHS Mandatory Guidelines for Federal Workplace Drug Testing Programs. It is the Contractor’s responsibility to ensure compliance with the DHHS Mandatory Guidelines in the collection process.

2.2. 3 Collection Site Security

The collection site must be secure 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.

2.2.4 Federal Drug Testing Custody and Control Form (CCF)

The personnel assigned for collections at clinic and on-site facilities shall use the Office of Management and Budget approved Federal CCF when collecting urine specimens for the workplace drug testing programs. Federal CCF forms will be provided along with the collection kit by the Fort Meade FTDTL. Forms are to be completed as described in the SAMHSA guidelines.

2.2.5 Blind Proficiency Urine Specimen Submissions

The contractor will provide blind positive and negative Quality Control proficiency specimens on a continuous basis in accordance with SAMHSA guidelines. The contractor will create dummy CCF forms, pour the QC samples into standard collection vials, seal and initial those vials, and submit the specimens to the Fort Meade laboratory in a manner consistent with actual collection submissions.

The MRO copy of each CCF specimen submission is labeled with a sticker identifying whether the specimen is a QC negative or QC positive by drug type(s) as prepared by the contractor’s QC sector.

When laboratory results are entered into the vendor’s data files, the laboratory results are compared with the expected drug results for accuracy in drug testing. In the event of a discrepancy, the contractor shall notify the COR within 2 business days.

TASK 3 - MRO REVIEW AND REPORTING

2.3.1 Result Reporting

Certified laboratory results shall be/are forwarded through a secure web portal that is provided and maintained by the Contractor. The MRO shall post final result reports and documentation to the respective Military Services and DOD Agency via the web portal.

2.3.2. The MRO Review and Reporting Process

The MRO shall review all non-negative test results (i.e., positive, adulterated, substituted, invalid) and all negative and dilute specimens before reporting the results to the Federal Agency's designated representative. Negative specimen results may be reviewed and reported by staff under the direct, personal supervision of the MRO.

The MRO process consists of (a) Administrative review of documents, (b) Interview with the donor (as required), (c) Handling retest requests (as required), (d) Result interpretation and verification, and

(e) Reporting of results to the Federal Agency's designated representative.

2.2.3 Administrative Review of Documents:

The collector is required to send the MRO Copy of the Federal Custody and Control Form (CCF) (Copy 2) to the MRO within 24 hours or one business day after the collection. If the MRO receives a laboratory test report for a specimen without having received the MRO copy of the Federal CCF, the MRO shall contact the collector. If the MRO copy is not available, the MRO shall obtain another legible copy of the Federal CCF (e.g., collector or employer copy) that has been signed by the donor and has the donor's name and telephone number(s).

Laboratory Report - Federal CCF (Copy 1) and/or Computer-Generated Electronic Report: Certified laboratories report drug test results only to the MRO. The laboratory and the MRO shall have procedures in place to ensure the consistency and confidentiality of the reports (i.e., hardcopy and electronic). The laboratory will send drug test reports by secure electronic transmission.

The MRO shall verify laboratory reports for a specimen and that the CCF has been completed correctly.

DHHS Required Information: The computer-generated electronic report contains the DHHS-required information as follows:

• Laboratory name and address

• Federal Agency name

• MRO name

• Specimen identification number

• Donor identification from the Federal CCF (e.g., SSN, employee ID number)

• Collector name and telephone number

• Reason for test (if provided)

• Date of collection

• Date received at laboratory

• Certifying scientist's name

• Date certifying scientist released the results

• Test results

• Additional comments concerning the specimen's testing and processing, as listed in the "Remarks" line of the Federal CCF

Federal CCF or Specimen Errors: A laboratory or an MRO may identify errors made on a Federal CCF, or a laboratory may identify a problem with a specimen during processing. The various types of errors are outlined below:

a) Uncorrectable errors that result in specimen rejection by the laboratory and test cancellation by the MRO:

− Specimen ID number on the Federal CCF and bottle label/seal do not match or the number is missing on either the Federal CCF or the specimen bottle label/seal, − Specimen bottle label/seal is missing or broken on the specimen from a single specimen collection or on a primary specimen (Bottle A) of a split specimen collection and the split specimen (Bottle B) cannot be re-designated as the primary specimen, − The collector's signature and printed name are omitted from the CCF

− There is insufficient specimen volume for testing.

b) Correctable errors that result in specimen rejection and/or cancellation unless corrected by a memorandum for the record (MFR) from the collector:

− The collector failed to sign the CCF (but the printed name is present)

− The collector used a non-Federal form or an expired version of the Federal CCF.

c) Federal CCF omissions and discrepancies that are considered insignificant when they are infrequent (i.e., when a collector does not make the error more than once a month). Examples include, but are not limited to:

− No collection date/time, − No courier entry, − No specific delivery service name

− Donor name included on the laboratory copy of the CCF.

d) Administrative errors made by laboratory staff that is judged by the MRO to have a significant impact on the forensic defensibility of the results unless corrected by an MFR. Examples include, but are not limited to:

− No signature on the CCF, − No documentation of bottle seal condition on the CCF

− No certifying scientist signature on the CCF.

Federal CCF Remarks: Collectors are required to include comments on the "Remarks" line in Step 4 (the collector's section) of the Federal CCF to document any unusual donor behavior or incidents occurring during the collection. Laboratory staff are required to include comments on the "Remarks" line in Step 5a of the Federal CCF to document any issues concerning the specimen (e.g., re-designation of the A and B Bottles), as well as explanatory reporting comments required by the program (e.g., the basis for reporting a specimen as adulterated, the basis for reporting an "invalid result," reason for rejection).

The MRO evaluates whether information provided on the Federal CCF "Remarks" lines have a significant impact on the forensic defensibility of the drug test results. If the MRO believes the forensic defensibility of the results is affected, he or she either attempts to obtain an MFR or cancels the test.

2.2.4. Interview with the Donor (as required):

The MRO shall contact and interview the donor when the donor's specimen is reported by the laboratory as non-negative (i.e., positive, adulterated, substituted, invalid).

The MRO shall attempt contact as soon as possible after receiving the report (within 48 hours). The MRO copy of the Federal CCF will contain daytime and evening telephone numbers for the donor.

The MRO should establish guidelines as to what constitutes a reasonable effort to contact a donor. All attempts made to contact the donor shall be documented.

If the MRO, after making all reasonable efforts, has been unable to contact the donor within 14 days after the date on which the MRO received the test result from the laboratory:

a) The MRO shall inform the Federal agency of his or her inability to contact the donor.

1) The MRO shall not reveal the test result or any information about the drug test.

2) The Federal agency must:

o Confidentially direct the donor to contact the MRO within 5 days, and;

o Inform the MRO once the donor has been directed to contact the MRO or if the Federal agency was unable to contact the donor.

b) The MRO may verify a test result without having communicated directly with the donor (i.e., a non-contact determination) for the following reasons:

1) The donor expressly declines the opportunity to discuss the test result, or

2) The Federal agency has contacted the donor and instructed the donor to contact the MRO, but the donor has not contacted the MRO within 5 days after being contacted by the Federal agency.

The Interview Process: The MRO shall:

• Request the donor to provide information that will verify the donor's identity (e.g., employee identification number, SSN) to ensure that it agrees with the information documented on the Federal

CCF.

• Inform the donor, prior to obtaining any information, that medical information provided during the review process may be disclosed to the Federal agency.

• Inform the donor of the laboratory reported test result(s).

• Take action based on the donor's response:

1) If the donor admits use of an illegal drug consistent with the test results or admits that he or she tampered with the specimen, advise the donor that the test result will be reported to the Federal agency.

2) If the donor does not admit use of an illegal drug or specimen tampering, ask the donor if there is any possible medical explanation for the test result:

3) If the donor provides a possible medical explanation (e.g., claims that a positive result was due to a legally prescribed medication or that the drug use was associated with a valid medical procedure), require the donor to provide appropriate supporting documentation within a specified time.

4) If the donor has no valid medical explanation for the result, advise the donor that the test result will be reported to the Federal agency.

• For positive, substituted, or adulterated results: MRO informs the donor that he or she may have the specimen retested at a second certified laboratory. The retest request shall be made within 72 hours of the interview with the MRO.

2.1.4. Handling retest requests (as required)

The following are rules for handling retest requests for positive, adulterated, or substituted specimens:

a) The donor has 72 hours from the time the MRO notified the donor that his or her specimen was reported positive, adulterated, or substituted to request the retest.

b) The MRO shall request the retest of the split (Bottle B) specimen in writing (i.e., a memorandum or letter format). However, for retests, the written request may be mailed, faxed, or electronically sent to the laboratory where the primary specimen was tested and shall contain the following information:

− MRO name and address (use MRO letterhead), − Laboratory name and address (i.e., Laboratory A) where original analysis was performed, − Specimen ID Number on the Federal CCF, − Laboratory Accession Number (i.e., the number assigned by Laboratory A to the specimen when it was accessioned), − Request for confirmatory retest for the drug/metabolite, adulterant, or substitution reported by Laboratory A − Name and address of the DHHS-certified laboratory (i.e., Laboratory B) selected to retest the split (Bottle B) specimen.

c) A Laboratory B retest may be requested by the MRO, the Federal agency, or the donor. In most instances where retesting is requested, the first laboratory will have blanket purchase agreements with another certified laboratory to make the billing and payment process easier.

d) If the specimen cannot be tested by a second laboratory (e.g., insufficient volume, lost in transit, Bottle B not available, no other certified laboratory tests for the specific adulterant), the MRO shall direct the Federal agency to immediately collect another specimen using a direct observed collection procedure. If the test is cancelled because no other certified laboratory tests for the specific adulterant, the MRO notifies the appropriate regulatory office.

e) The second DHHS-certified laboratory reports retest results directly to the MRO using Copy 1 of the Federal CCF.

f) The MRO reports the result to the Federal agency and the donor.

2.2.5. Result Interpretation and Verification

The MRO interprets drug test results based on:

a) The laboratory results,

b) The donor's explanation and supporting documentation

c) The MRO's medical assessment of the donor's behavior and physical symptoms during the donor interview The MRO shall report only verified results to the Federal agency. The MRO shall inform the Federal agency when a positive, adulterated, or substituted result was verified as negative.

No regulatory requirements exist that require MROs to use specific procedures to review drug tests;

however, using a standard procedure better ensures that the MRO review for each specimen is complete and thorough. A simple checklist outlining required tasks may be created to aid in assuring consistency and completeness of the process.

A. Privacy and Security

The Contractor shall ensure that all findings from performing MRO functions are clearly recorded and documented into the web portal database, and, as necessary, are protected by Privacy Act of 1974 and Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated safeguards to ensure confidentiality of health information.

B. 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.

TASK 4 – ACCESS TO RECORDS AND LITIGATION SUPPORT

2.4.1. Access to Records:

Donors may, upon written request through the MRO and the agency, have access to: records relating to his or her drug test; any records relating to the results of any relevant certification, review or revocation of certification proceedings; and other relevant documents.

2.4.2. Litigation Packages:

The MRO must provide a litigation package to the agency upon request. The MRO serves as a liaison by forwarding requests from the agency to the laboratory, and then forwarding the completed litigation package from the laboratory back to the agency. The litigation package will contain, at a minimum, all the information as described in Chapter 6, Section D of the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention, Medical Review Officer Manual (October 1, 2010). This includes, but is not limited to:

a) A cover sheet that provides a brief description of the drug testing procedures and specimen validity tests performed on the donor’s specimen;

b) A table of contents page that lists by page number all documents and materials in the package;

c) A copy of the Federal Custody and Control form (CCF) with any attachments, internal chain of custody documents for the specimen, memoranda (if any), a copy of the electronic report (if any) generated by the instrumented initial test facility (IITF) or laboratory;

d) A brief description of the initial drug tests and specimen validity tests procedures, instrumentation, batch quality control requirements, and copies of the test data for all internal chain of custody documents related to these tests;

e) From the laboratory: a brief description of confirmatory drug tests and confirmatory validity test procedures, instrumentation, batch quality control requirements and copies of the test data for all internal chain of custody documents related to these tests;

f) A list containing the names, business addresses, telephone numbers and e-mail addresses of each individual who was involved in the specimen collection and testing;

g) A copy of the resume or curriculum vitae for the certifying technician or certifying scientist that certified the test result;

h) A copy of the resume or curriculum vitae for each of the IITF Responsible Technicians or each of the laboratory’s Responsible Persons; and

i) A copy of the resume or curriculum vitae for the MRO and any other witness who may provide testimony.

2.4.2. Witnesses:

In support of litigation, the Contractor will make witnesses available by e-mail, telephone and in person. MROs with first-hand knowledge of the specific donor and specimen at issue will be the most common witnesses, but other technicians and/or scientists may be needed as will. Witnesses may participate in litigation preparation, testify at depositions, and testify at hearing. Testimony may be telephonic, via video-teleconference, or in person. When appropriate, witnesses may be called as experts, rather than as a fact witness. Witnesses who are required to provide expert testimony may be required to produce additional information, including a written report in accordance with Federal Rule of Civil Procedure 26(a)(2). The specific witness(es) who will testify, the form of testimony, and the location of the proceeding is determined by the parties to the litigation and by the presiding official, typically a judge or arbitrator.

3. SPECIAL REQUIREMENTS

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

3.1. KEY PERSONNEL

The Contractor shall provide qualified personnel for the key positions under this contract.

Among the key positions is the 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 SAMHSA 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 but not limited to 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. 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 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 but not limited to, all applicable regulations promulgated by the DHHS and SAMHSA, DOD and applicable DOD Agency policies. This person designated as PM will be the ultimate point of contact to address and resolve issues, concerns, and problems related to contractor performance. Additionally, the PM shall fulfill project management responsibilities to ensure that all MRO tasks are performed efficiently, accurately, on-time, and in compliance with the requirements.

Project/Task Management responsibilities include: (1) ensuring that MRO tasks are managed consistently with overall contract requirements, and (2) ensure timely and accurate submission of invoices.

Other key personnel are the MROs. 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

• 69 FR Part 19644 (April 13, 2004) DHHS Mandatory Guidelines for Laboratory Requirements for Specimen Testing & Reporting Criteria

• 49 CFR Part 40 Department of Transportation Mandatory Guidelines for Federal Workplace Drug Testing

The MRO shall be knowledgeable about what tests were used to generate the specimen results that he/she reviews 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 MRO may be an employee, or a contractor, for a Federal agency; however, the following restrictions apply:

• 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.

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.

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.

3.2. GOVERNMENT FURNISHED MATERIALS

When available, 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. 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.

3.3. FACILITY REQUIREMENTS:

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.

Collection Site Facilities: Collection site facilities must meet the following minimum SAMHSA guidelines:

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

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 SAMHSA. The Contractor is responsible for assuring that the collectors meet the requirements stated in section 3.2.2.

Worldwide Collection Capability: The Contractor shall, at a minimum, have the capability to provide collection services at the worldwide sites specified, but not limited to the sites, in

Attachment1. The Contractor shall certify that all partnering clinics meet the minimum guidelines specified above.

3.4 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:

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.

Systems of Record

In order to meet the requirements of 5 U.S.C.