HIV_PWS_10172017.docx

PERFORMANCE WORK STATEMENT

Fourth Generation HIV Testing and Reporting

1. GENERAL. This is a non-personal services contract to provide testing services for the detection of antigen and antibodies of Human Immunodeficiency Virus(es) (HIV) in support of the United States (U.S.) Army and U.S. Military Entrance Processing Command (USMEPCOM). HIV testing services include, but are not limited to, the provision of collection supplies, specimen collection/preparation/shipment instructions and training, courier services, specimen testing (including required quality programs), result reporting, specimen storage/re-aliquot/final disposition services, required information management systems, and help desk customer support services. The Government will not exercise any supervision or control over the contractor or any subcontracted service provider(s) performing the services herein. Such subcontract service provider(s) shall be accountable solely to the contractor who, in turn, is responsible to the Government.

IT IS THE GOVERNMENT’S INTENT TO TRANSITION TO GOVERNMENT PERFORMED TESTING OVER THE COURSE OF THIS CONTRACT. TESTING WILL TRANSITION FROM CONTRACTOR PERFORMED TO GOVERNMENT PERFORMED TESTING IN A PHASED MANNER FOLLOWING THE BASE PERIOD OF PERFORMANCE. ANTICIPATED COMPLETION MAY BE AS EARLY AS THE THIRD YEAR OF PERFORMANCE. THE TRANSITION TIMELINE IS CONTINGENT UPON THE DEVELOPMENT OF GOVERNMENT CAPABILITIES AND CAPACITY.

1.1. BACKGROUND. The Assistant Secretary of Defense for Health Affairs (ASD (HA)) in coordination with the Under Secretary of Defense for Personnel and Readiness (USD (P&R), the General Counsel of the Department of Defense (DOD), and the ASD for Reserve Affairs are responsible for establishing policies, procedures, and standards for the identification, surveillance, and personnel management of military service members who have serologic or other evidence of HIV infection. The ASD (HA) and USD (P&R) also have purview over the screening and qualification policy for applicants into the Armed Forces.

1.2. SCOPE OF WORK. The contractor shall provide qualified personnel, services, materials, equipment supplies, information systems, and facilities, except as identified in Paragraph 3, Government-Furnished Equipment/Property, necessary to perform testing services for the detection of antibody against and/or antigens of HIV. The contractor shall employ Food and Drug Administration (FDA) approved tests, software, testing instruments, and methodologies. Approved testing protocols covered by this contract are established and updated by the HIV Diagnostics and Reference Laboratory (HDRL), Walter Reed Army Institute of Research (WRAIR), 9100 Brookville Rd., Bldg 508, Silver Spring, MD 20901. The contractor shall comply with all applicable laws, rules and regulations, including but not limited to those listed in paragraph 6 of the PWS.

1.2.1. The contractor shall perform initial HIV screening tests on serum and/or plasma specimens submitted by Army Military Treatment Facilities (MTFs) and/or other Submitting Activities (SA), (e.g., the U.S. Army Reserve (USAR) sites and U.S. Army National Guard (ARNG) sites (typically coordinated by the Reserve Health Readiness Program (RHRP)). The contractor shall also provide services as ordered to augment testing for the United States Military Entrance Processing Command (USMEPCOM). The contractor shall provide screening tests which employ state-of-art FDA-approved fourth generation technology for simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma. In the event that more sensitive and/or specific FDA approved screening tests become available, the contractor, upon the direction of the Government (HDRL) through the Contracting Officer (KO), shall employ the more sensitive/specific methodology.

1.3. WORKLOAD VOLUME. The contractor may receive approximately 60,000 specimens monthly from Army Active Duty MTF and USAR RHRP sites; and 13,800 specimens from ARNG. Submitting activities for the U.S. Army MTFs/other sites, USAR, and ARNG sites are stated in Exhibit A.

1.3.1. The contractor may receive samples from USMEPCOM SAs for contingency testing. For planning purposes USMEPCOM currently submits approximately 24,000 specimens monthly to HDRL for testing. Submitting activities for the USMEPCOM are stated in Exhibit A.

1.3.2. The contractor may also receive approximately 5,000 specimens per month from the U.S. Army Clinical Laboratories from outside the continental United States (OCONUS) (includes Alaska and Hawaii) locations as a contingency – Germany (3), Italy (1), Japan (1), Saudi Arabia (1), South Korea (2), Turkey (1), Iraq (5), Kuwait (1), and Afghanistan (1).

1.4. SAFETY REQUIREMENTS. The contractor shall maintain safety and health standards compliant with requirements of the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC) and state and local requirements, if any.

1.5. SECURITY REQUIREMENTS. The contractor shall be responsible for the security of all patient information, testing results, specimens, supplies, materials, and equipment and shall ensure compliance with all applicable security requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), DOD regulations/guidance (including but not limited to Military Health System Automated Information Security; Privacy Act and data at rest policies), and this PWS.

1.5.1. The contractor shall ensure the protection of all sensitive, private, protected, and patient/applicant/source health information. Additionally, neither the contractor nor any of the contract service providers (CSPs) shall disclose or cause to disseminate any information concerning operations of military activities. Such action(s) could result in violation of the contract and possible legal actions. If there is a loss or compromise of any protected data, the contractor shall indemnify the Government and ensure that the Government bears no cost.

1.5.2. All inquiries, comments, or complaints arising from any matter observed, experienced, or learned of as a result of or in connection with the performance of this contract, the resolution of which may require the dissemination of official information, shall be directed to the Contracting Officer’s Representative (COR) and the Contracting Officer (KO). The contractor shall not release such information, unless authorized by the KO.

1.5.3. The contractor shall only conduct business with designated Government personnel listed as points of contact (POCs). The COR (or KO) will provide the names of designated POCs within 30 calendar days of contract award and within 15 calendar days when any change occurs.

1.5.4. U.S. Government records, original results and reports and copies thereof, verified original data, corrected data, and corrected supporting final reports are maintained by the contractor, but remain the property of the U.S. Government. These records, data, files, results and reports must be surrendered to the COR and the KO upon termination or completion of this contract.

1.5.5. INFORMATION SECURITY.

1.5.5.1. TELECOMMUNICATION.

1.5.5.1.1. All contractor systems that communicate with DOD systems shall interconnect through the established Military Health System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway. For all Web applications, contractors shall connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ).

1.5.5.1.2. The contractor shall follow Army Regulation (AR) 25-1, “Army Knowledge Management and Information Technology, AR 25-2, “Information Assurance (IA)”, and DOD 6025.18-R, DOD Health Information Privacy Regulation.

1.5.5.1.3. In accordance with contract requirements, contractors shall connect to the B2B gateway via a contractor procured Internet Service Provider connection. The contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. This shall include acquiring and maintaining the circuit to the B2B gateway and acquiring a VPN device compatible with the MHS VPN device.

1.5.5.1.4. The contractor shall comply with DOD guidance regarding allowable ports, protocols and risk mitigation strategies and shall provide, maintain and configure VPN concentrator that complies with DOD security standards.

1.5.5.1.5. All costs for VPN hardware and software shall be incurred by the contractor.

1.5.5.2. DEPARTMENT OF DEFENSE ACCREDITATION REQUIREMENTS.

1.5.5.2.1. The contractor shall provide all required information to support and initiate the Laboratory Information Management System (LIMS) accreditation efforts to remain compliant with all current accreditation needs and efforts. This shall include system-specific information presented in the style designated by current DOD and Department of the Army (DA) regulations and policies.

1.5.5.2.2. The contractor shall provide information for the Risk Assessment to the COR for all networking IT applicability no later than three (3) months after contract award.

1.5.5.3. SECURITY CLEARANCES.

1.5.5.3.1. Personnel to be assigned to an Automated Data Processing (ADP)/IT position must undergo a successful security screening before being provided access to DOD information technology resources. Prior to an employee being granted interim access to DOD sensitive information, the COR must receive notification that the Office of Personnel Management has scheduled the employee's investigation. This requirement shall (must) be met by contractors, subcontractors and other who have access to information systems containing information protected by the Privacy Act of 1974 and protected health information under HIPAA. Background checks are required for all ADP/IT personnel who receive, store, display, or transit sensitive information. Employees shall (must) have at a minimum an ADP Sensitivity Designation of Level II to access the DOD Network.

1.5.5.3.2. The background check/investigation is completed by the Government, and will be at no cost to the contractor.

1.5.5.3.3. The contractor shall submit all documentation necessary for the background check to the COR not later than (NLT) 30 calendar days after contract award.

1.5.5.3.4. For CSPs Requiring a Common Access Card (CAC). The contractor shall coordinate with the MEDCOM COR for adjudication procedures for Tier 1 (T1) background investigations for each CSP. Before CAC issuance, the CSP requires, at a minimum, a favorably adjudicated T1 investigation in accordance with Army Directive 2014-05. The CSP will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the Federal Bureau of Investigations fingerprint check and a successfully scheduled T1 at the Office of Personnel Management (OPM).

1.5.5.3.4.1. Army Federal Investigative Standards (FIS). In accordance with FIS, OPM implemented T1 background investigations and discontinued the National Agency Check with Inquiries on 1 October 2014. A T1 represents the type of background investigation to be conducted for this effort. A T1 is required for each CSP to access the DoD computer network.

1.5.5.3.4.2. The preferred method for the submission of fingerprints is via digital fingerprint machine through the Defense Manpower Data Center (DMDC) Secure Web Fingerprint Transaction System. Digital fingerprints may be submitted at Army security offices. If digital fingerprints are not possible, a candidate must submit ink prints on the Standard Form 87 Finger Print Card. The use of hard copy fingerprint cards will delay the security review. The preparation and submission of the T1 shall be at the expense of the Government, upon commencement of services. The contractor shall advise their employees that a positive report is needed as a condition of employment under this contract. If the results of the T1 investigation result in derogatory findings, the Contractor shall be responsible for and pay all costs associated with the T1 investigation. The Government will not reimburse these costs.

1.5.5.4. BUSINESS TO BUSINESS (B2B) PARTNERS AND THIRD PARTY VENDORS.

1.5.5.4.1. General Security Requirements. 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. As a minimum, this shall include provisions for personnel security, electronic security and physical security as listed in the sections that follow.

1.5.5.4.2. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.5.5.4.2.1. Follow the DOD guidelines for submittal of ADP/IT background investigations and ensure all contractor personnel are designated as ADP/IT-I, ADP/IT-II, or ADP/ITIII where their duties meet the criteria of the position sensitivity designations outlined in AR25-2.

1.5.5.4.2.2. Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities.

1.5.5.4.2.3. Immediately report to the COR and deny access to any automated information system (AIS), network, or information if a CSP 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 any reason.

1.5.5.4.2.4. Ensure that all applicable CSPs, to include associated subcontractor employees, complete DOD IA training before issuance of network access to DOD AISs/networks and information, and annually thereafter. All CSPs working IA/IT functions must comply with DOD and Army training requirements in Department of Defense Directive (DODD) 8140.01, DOD 8570.01-M, and AR 25-2 within six months of appointment to IA/IT functions.

1.5.5.4.2.5. Army Training Certification Tracking System (ATCTS) registration for CSPs who require access to Government information systems. All CSPs with access to a Government info system must be registered in the ATCTS at commencement of services and must successfully complete the DOD IA Awareness prior to access to the information system and annually thereafter.

1.5.5.4.2.6. Access and General Protection/Security Policy and Procedures. All CSPs, to include associated subcontractor employees, shall comply with applicable installation, facility, and area commander installation/facility access and local security policies and procedures (provided by Government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshall Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements as direct by DoD, HQDA, and or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

1.5.5.4.2.7. HIPAA and Systems-Related Training. The contractor shall ensure that any CSPs who require access to the Government network and systems shall complete the initial DOD HIPAA training. Training may be accessed at http://jko.jfcom.mil. These CSPs shall complete all DOD systems and annual refresher training (e.g., Enterprise Mission Assurance Support Service (eMASS) training) in accordance with (IAW) current applicable DoD network accessibility requirements. CSPs shall complete all such required training within 30 calendar days after contract start date, or within 30 calendar days after on-boarding as a new CSP. The contractor shall submit all completed certificates to the COR or Alternate COR (ACOR) within five business days of certificate issuance.

1.5.5.5. ELECTRONIC SECURITY.

1.5.5.5.1. Contractor Information Systems (IS)/networks that are involved in the operation of systems in support of this contract shall operate IAW controlling laws, regulations, DOD, and local policy.

1.5.5.5.2. Accreditation efforts and risk management requirements apply to all DOD and contractor’s IS/networks that receive, process, store, display, or transmit DOD information. These technologies are broadly grouped as DOD IS, platform IT (PIT), IT services, and IT products. This includes IT supporting research, development, test and evaluation (T&E), and DOD-controlled IT operated by a contractor or other entity on behalf of the DOD. The contractor shall comply with appropriate processes for safeguarding IS. Certification is the determination of the appropriate level of protection required for IS/networks. Certification also includes a comprehensive evaluation of the technical and non-technical security features and countermeasures required for each system/network. IT products, services, and PIT are not authorized for operation through the full Risk Management Framework (RMF) process. These types of IT must be securely configured IAW applicable DOD policies and security controls and undergo special assessment of their functional and security-related capabilities and deficiencies.

1.5.5.5.3. The Assessment and Authorization effort occurs every three (3) years or if/when changes are made to the IS boundary. If the Authorizing Official (AO) does not accept the risk associated with an IS/Application, a Denial of Authorization to Operate will be issued and the IS/Application will not be allowed to operate or an “Authorization to Operate (ATO) with Conditions” will be issued. An ATO with conditions allows the IS to operate under certain conditions as established by the AO. Continuous monitoring efforts occur during this period and IT is reassessed annually as part of that effort.

1.5.5.5.4. The contractor shall comply with accreditation requirements, as specified by the Government that meet appropriate DOD IA requirements. IAW applicable current policy and regulations (e.g., DODI 8510.01). Information can also be found at http://iase.disa.mil/Pages/index.aspx Said requirements shall be met before the contractor’s system is authorized to access DOD data or interconnect with any DOD IS/network that receives, processes, stores, displays or transmits DOD data. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the Certification and Accreditation (C&A) process. They include, but are not limited to:

1.5.5.5.4.1. Attending and supporting C&A meetings with the Government

1.5.5.5.4.2. Supporting/conducting the vulnerability mitigation process

1.5.5.5.4.3. Supporting the C&A Team during system security testing

1.5.5.5.5. Information Assurance mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating system, routers, servers, development platforms and the application being delivered to the Government shall be in compliance with all known applicable DOD Computer Emergency Response Team Alert, Bulletin, and Technical Advisory Notices published during the past 36 months.

1.5.5.5.6. Disposing of Electronic Media. Contractor shall follow the DOD standards, procedures, and use approved products to dispose of unclassified hard drives and other electronic media, as appropriate, IAW DOD Memorandum "Disposition of Unclassified Computer Hard Drives," June 4, 2001. Contractor is required to also follow DOD guidance on sanitization of other internal and external media components in DODI 8500.2 "Information Assurance (IA) Implementation," 6 Feb 2003 (see PECS-1 in enclosure 4 Attachment 5) and DOD 5220.22-M "National Industrial Security Program Operating Manual (NISPOM)," (Chapter 8).

1.5.5.5.7. Information Assurance Vulnerability Management (IAVM). The contractor shall implement an IA vulnerability management program for all AIS and corresponding subnets that are connected to or intermittently connect to DOD networks. The program shall meet the scope and intent of AR 25-2 and Medical Command (MEDCOM) IA policies to provide protection against known threats and vulnerabilities. Compliance with DOD IAVM alerts and bulleting is required for these systems and shall be completed within the specified timeframe.

1.5.5.6. INFORMATION SYSTEMS (IS)/NETWORKS PHYSICAL SECURITY.

1.5.5.6.1. The contractor shall employ physical security safeguards for IS/Networks involved in processing or storage of Government Data to prevent the unauthorized access, disclosure, modification, destruction, use, etc., and to otherwise protect the confidentiality and ensure use conforms with DOD regulations. In addition, the contractor shall support a Physical Security Audit performed by the Government of the contractor's internal information management infrastructure, to be performed initially as required by applicable Government policy and regulations; and then to be re-performed annually as required..

1.5.5.6.2. The MHS Physical Security Audit information is available at:

http://iase.disa.mil/stigs/Pages/vendor-process.aspx

1.5.5.6.3. The contractor shall correct any deficiencies identified by the KO of the contractor's physical security posture, within timelines as specified by the KO with recommendation from the COR.

1.5.5.7. SPECIAL REQUIREMENTS FOR PROTECTED HEALTH INFORMATION.

1.5.5.7.1. Whenever a contract is awarded that requires the vendor to collect, use, copy, access or store Protected Health Information (PHI) in commercial office space, the contractor shall:

1.5.5.7.2. Notify the COR and MEDCOM HIPAA Security Manager.

1.5.5.7.3. Follow all Data At Rest and DOD requirements for secure disposal, destruction, and/or sanitization of all equipment that contained PHI.

1.6. The following is a list of legal Federal holidays as referred to in the contract:

New Year’s Day, January 1 Martin Luther King’s Birthday, third Monday in January President’s Day, third Monday in February Memorial Day, last Monday in May Independence Day, July 4 Labor Day, first Monday in September Columbus Day, second Monday in October Veteran’s Day, November 11 Thanksgiving Day, fourth Thursday in November Christmas Day

1.7. TESTING PHASE IN PERIOD. To ensure a smooth transition to contractor performance, minimize any decreases in productivity and to prevent possible negative impacts on additional services, the contractor shall have personnel on board during the 180-day phase in period. During the phase in period, the contractor shall become familiar with test and data transfer requirements, and make all necessary preparations to provide full contract services on 1 March 2018. Government personnel shall be authorized to visit the testing facility and assess the contractor's ability to meet contractual requirements. The contractor shall provide, within 10 calendar days of award of the contract, a detailed plan for the phase in period to include timeline to meet the electronic interface requirements of the contract. The contractor must provide a monthly status report, due the fifth business day of each month, on efforts to achieve the required electronic data transfer capability until it is complete.

1.8. SEXUAL HARASSMENT AND ASSAULT RESPONSE PROGRAM (SHARP).

1.8.1. The contractor shall comply with Office of The Surgeon General (OTSG)/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013 and with OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program, 29 Mar 2016. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

1.8.2. The contractor shall require all CSPs with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR. This reporting policy also applies to sexual assault incidents involving MEDCOM personnel that occur on the contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

1.8.3. The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR. This reporting policy also applies to sexual harassment incidents involving MEDCOM personnel that occur on the contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

1.9. KEY PERSONNEL. The contractor shall furnish the below listed qualified key personnel to assure satisfactory performance of the services required by the PWS. In addition to the position qualifications in Exhibit M, all CSPs shall have the ability to perform the applicable duties consistent with their license, certification, and this PWS. All CSPs shall comply with all federal requirements and any applicable state regulations regarding their license, certification, or registry.

Position

Project Manager

Laboratory Director

Clinical Consultant

Technical Supervisor

General Supervisor

1.9.1. Project Manager. The contractor shall designate a full-time Project Manager and alternate(s). The Project Manager (or alternate) shall be on site and responsible for overall contract performance, and shall have full authority to act for the contractor on all matters related to contract operations under their purview. The Project Manager (or alternate) shall be available by email and phone 24/7/365/366.

1.9.1.1. Notification. The contractor shall provide in writing to the KO and the COR, prior to contract start date, a list of the name and phone number of the Project Manager, along with the names and phone numbers of any alternates, if applicable. The contractor shall provide updates to this list, if the information changes, NLT 10 calendar days prior to the change.

1.9.1.2. The contractor shall submit to the COR and KO, within 15 calendar days of award date, information on how the Project Manager and alternate(s) may be contacted after regular duty hours.

1.9.1.3. The Project Manager (or alternates) shall meet, as necessary, with Government personnel designated by the COR or KO to discuss immediate administrative and technical issues and problem areas.

1.9.2. The contractor shall notify the KO and COR within three business days of any change in the designations of the other key personnel (Laboratory Director, Clinical Consultant, Technical Supervisor or General Supervisor).

1.10 Quality Control (QC). The contractor shall maintain an industry quality standard-compliant process for quality control, such as ISO 9000. The contractor shall maintain a complete Quality Control Plan (QCP), to include the use of performance metrics, that shall ensure the requirements of the contract are provided as specified in this PWS. The contractor shall provide copies of the QCP to the KO and COR/ACOR NLT 30 calendar days after contract award. The contractor shall update/revise the QCP as necessary, and submit the updated/ revised QCP to the KO and COR for review/comments NLT ten calendar days prior to implementation. The QCP shall be incorporated into the contract by reference as a compliance document.

1.11. GOVERNMENT-CONTRACTOR MEETINGS.

1.11.1. POST AWARD CONFERENCE. The contractor shall attend the post award conference convened by the contracting activity or contract administration office IAW Federal Acquisition Regulation Subpart 42.5. The KO, COR, and other Government personnel, as appropriate, may meet periodically (but not less than quarterly) with the contractor to review the contractor’s performance. At these meetings, the KO will apprise the contractor of how the Government views the contractor’s performance and the contractor shall apprise the Government of issues/concerns, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

1.11.2. PERFORMANCE EVALUATION MEETINGS. The Project Manager shall meet on-site or telephonically with the designated Government representatives (which may include the Contract Specialist, KO, COR, HDRL representative, and other Government-authorized representatives) quarterly, or more frequently at the request of the KO, to discuss the contract program and review the contractor’s performance. The written minutes of these meetings, prepared by the Project Manager, shall be signed by the contractor and forwarded to the COR and KO within fifteen (15) calendar days of the meeting. The COR shall notify the KO and the contractor of date, time and location of meetings at least one week in advance.

1.11.3. CONTRACT DISCREPANCY REPORT (CDR) MEETINGS. If a CDR is issued, the KO may require a meeting to discuss the issues. The written minutes of these meetings shall be prepared by the COR and distributed to the contractor, KO, and Contract Specialist within fifteen (15) calendar days of the meeting. The minutes shall be signed by the contractor, contractor's Project Manager, KO, and COR. Should the contractor not concur with the minutes, his company representative shall state so in writing within the time specified by the CDR and shall submit this notice to the COR and KO.

2. DEFINITIONS AND ACRONYMS.

2.1. DEFINITIONS.

BLIND QC PANEL SAMPLES. Routine serum samples of character known to the Government and of character and identity unknown to the contractor, provided by the Government for Quality Control purposes.

CERTIFYING OFFICIAL. The contractor's employee or agent who verifies that testing was accomplished by the methodology reflected in the contract and reports that results are in fact those obtained by that methodology.

CLINICAL AND LABORATORY STANDARDS INSTITUTE. Formerly National Committee for Clinical Laboratory Standards. Current standards are located at Clinical Laboratory Standards Institute website: www.clsi.org/

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) OF 1988 (CLIA 88). Current CLIA requirements are located at the Center for Medicare and Medicaid Services website: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html.

COMPOSITE HEALTH CARE SYSTEM (CHCS). The DOD's standard Hospital and Laboratory Information Management System.

CONFIRMATORY. To prove or establish the correct test results.

CONFIRMATORY TEST. Tests recommended by the CDC as confirmatory tests for HIV 1 and 2 screening tests.

DEFENSE HEALTH INFORMATION MANAGEMENT SYSTEM (DHIMS). The DOD Acquisition office for centrally managed MHS clinical information technology systems that support the delivery of health services throughout the MHS.

ETIOLOGIC AGENT. All blood, serum and/or plasma specimens with repeatedly reactive results, all redrawn specimens, and all proficiency testing panels/series.

FAMILY MEMBER PREFIX (FMP). A two-digit numeric code used as a prefix to the Social Security Number (SSN) that categorizes health care beneficiaries. (See Exhibit B.)

FORCE TESTING. Periodic or event-driven HIV testing of military personnel based upon administrative directives designed to preserve the deployability of forces.

GOVERNMENT ACTIVITY. Any of the Uniformed Services or RHRP coordinated facilities submitting samples for HIV testing.

IMMUNOASSAY (IA) CUTOFF. Determined by the manufacturer using the mean negative control absorbance value (NCx) and supplied formula.

INITIAL SUBMISSION SAMPLE. Serum samples that have had no HIV testing performed under this contract.

LOCAL REQUEST FORM. Form furnished by the Government to submit specimens to the contractor. Form(s) may be prepared via manual, computer, or typewritten methods.

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

QUALITY ASSURANCE. The Government procedures to verify that services being performed by the contractor are performed according to acceptable standards. In this PWS, Quality Assurance also refers to the contractor’s responsibility to ensure compliance with regulatory and accreditation standards.

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

SCREENING. To separate out non-reactive test results from reactive test results.

SPECIMEN. A quantity of human blood/serum and/or plasma provided for test purposes.

SUBCONTRACTOR. One that enters into a subcontract with and assumes some of the obligations of the primary contractor.

SUBMITTING ACTIVITY. Any activity submitting specimens for HIV testing.

TEST. Screening, repeat IA testing, confirmatory or supplemental testing for the detection of antibody and/or antigen to HIV in human serum or plasma.

TRANSFER TUBE. Defined as any tube used to collect, transport, transship, and store samples under terms of the PWS.

VERIFYING THE CONTENT OF THE CONTAINER. For the purpose of this contract, verifying shall consist of physically checking each package to make sure appropriate tubes are in the container to be picked up; verification does not consist of physically counting the tubes in each container.

WORK SHEET. An internal work performance report containing work product information related to screening test results to detect antibodies to HIV.

2.2. ACRONYMS.

3. GOVERNMENT FURNISHED ITEMS.

3.1 SPECIMENS FOR TESTING.

3.1.1. The Government will provide human serum specimens to the contractor via contractor-provided shipping as detailed in Section 4. The Government will provide centrifuged serum specimens in 16 x 100 mm size tubes with integral serum separation gel from the SAs listed in Exhibit A. Each DOD Government site has clinical centrifuges. If a more advanced centrifuge is required in order to comply with the test kit proposed by the contractor, the contractor shall be required to furnish them to all sites, including delivery, set-up, and maintenance, at the contractor’s expense.

3.1.2. Whenever the Government cannot have the specimens delivered to the contractor's testing facility within five (5) calendar days after sample collection, the Government will provide separated frozen serum specimens in screw-capped transfer tubes from the SAs listed in Exhibit A. In the event the contractor is required to perform contingency testing for USMEPCOM SAs MEPS staff are able to spin specimens, however pouring and freezing of specimens shall not be performed. In this instance, upon receipt of specimens, the contractor is responsible for ensuring that the specimens are tested and poured/frozen locally to meet the FDA-approved testing window specific to the test kits and/or Government protocols, whichever is stricter and including any confirmatory testing performed by the Government.

3.1.3. The Government will provide separated frozen plasma specimens for confirmation and/or verification samples required for Nucleic Acid Testing from SAs listed in Exhibit A. These specimens will be shipped directly to HDRL, WRAIR.

3.1.4. The Government will provide Proficiency Test panels to the contractor for testing and reporting on a quarterly basis. The Government will ship these panels to the contractor at Government expense.

3.2. MATERIALS.

3.2.1. The Government will apply contractor-provided CHCS barcode labels to the original blood collection tubes and/or transfer tubes at the SAs with CHCS as identified in Exhibit D.

3.2.2. The Government will provide guidelines for contractor computer program logic, contractor data entry requirements, contractor computer data verification systems, and master files and record structure for data file storage and reporting utilized by the contractor. (See Exhibit E.) If the Government deems necessary, it will provide additional program installation and instructions for specification use and data entry verification for contractor interface with Government facilities. The Government will not authorize alterations to Exhibit E guidelines without written consent of the KO. If the contractor needs alterations made, the contractor shall notify the COR and KO, in writing, describing in detail the modifications required; Government to approve any changes prior to implementation.

3.2.3. As necessary, the Government will provide corrected data to verify and update maintained files and logs to facilitate result reporting.

3.2.4. As necessary, the Government will provide information for security sticker specification to be used on CD-ROM or other media during transshipment from one site to another when sensitive Privacy Act or protected health data is contained within.

3.3. GOVERNMENT RESPONSIBILITIES.

3.3.1. The Government will provide the appropriate testing and resulting algorithms to the contractor.

3.3.2. The Government will provide repeat testing, confirmatory testing and final interpretation of HIV infection status of all Initially Reactive specimens.

3.3.3. The Government will provide configuration of the contractor’s VPN to Government specifications to insure compliance with Government requirements pertaining to external computers connecting to Government systems. The Government will electronically monitor and provide timely configuration maintenance of the VPN tunnel and will provide support to its submitting sites receiving laboratory testing services from the contractor.

3.3.3.1. For USMEPCOM, the Government will provide configuration of the contractor’s SOA to be handled by USMEPCOM’s SOA for internal and external connectivity for all data exchange under VPN to Government specifications to ensure compliance with Government requirements pertaining to external computers connecting to Government systems. The Government will electronically monitor and provide timely configuration maintenance of the SOA to be handled by USMEPCOM’s SOA for internal and external connectivity for all data exchange VPN tunnel and will provide systems support to its submitting sites receiving contingency laboratory testing service from the contractor.

3.3.4. The Government will correct demographic data errors detected during the verification process in the Government computer system. If the Government identifies a contractor performance issue(s) or system failure that results in error, the Government will notify the contractor. It will be the contractor’s responsibility to identify and correct errors that have been detected at no cost to the Government.

3.3.5. The Government will be responsible for the security and transmission accuracy of the patient data sent thought the VPN tunnel from the time such data leaves the contractor’s device and enters into the Government LIMS.

3.3.6. The COR, assisted by technical designees as necessary, will conduct quarterly Quality Assurance (QA) site visits to determine if the contractor is performing IAW the terms of the PWS. QA visits are typically announced; however the Government reserves the right to conduct unannounced QA visits. A copy of the site visit trip report will be provided to the contractor by the KO.

3.4. DESIGNATED GOVERNMENT PERSONNEL LIST. The COR will provide an initial list of individuals authorized to interact with the contractor regarding site-specific issues, and/or access LIMS and management reports. The Government will provide the initial list within 30 calendar days after award; thereafter, the contractor shall maintain this list based upon COR coordination.

3.5. GOVERNMENT QUALITY ASSURANCE (QA). The Government shall evaluate the contractor’s performance under this contract IAW the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government will do to assess whether the contractor has performed IAW the performance standards and contract quality requirements. The term “contract quality requirements” means the technical requirements in the contract relating to the quality of the service and those contract clauses prescribing inspection and other quality controls incumbent on the contractor to perform.

3.6. GOVERNMENT PROFICIENCY PANEL TESTING. The Army's HDRL at WRAIR shall provide Proficiency Test panels (see paragraph 3.1.4) to the contractor for processing and reporting based on the specifications below:

3.6.1. The contractor shall perform an HIV viral marker Proficiency Test panel each month for the initial 3 months after the transition to the new platform; and then quarterly (once every 3 months).

3.6.2. The Government reserves the right to increase panels up to monthly intervals if the contractor scores less than 90% (percent) on two consecutive panels tested during the contract period. Government reserves the right to require more frequent Proficiency Testing, as necessary.

3.6.3. The viral marker panels will consist of at least 1000 microliters of serum for each of 10 coded specimens. One complete panel will be provided by HDRL for each testing location.

3.6.3.1. If the contractor uses more than one testing location for performance of work under this contract, the additional testing locations (to include subcontract laboratories) will be identified to HDRL. Each performing laboratory will receive separate Proficiency panels (reference paragraph 3.1.4.). It is the contractor’s responsibility to ensure that all timelines and quality/proficiency standards are met by all labs.

3.6.3.2. The HDRL personnel will notify the contractor of the impending shipment 24 hours prior to shipment. The contractor shall perform an IA screen on each specimen and return copies of each panel member result and raw run data to include quantitative positive control OD values; quantitative negative control OD values; quantitative sample panel OD values; quantitative cutoff OD values; copies of associated worksheets, technician initials performing test; and the signatures of the Laboratory Director and Technical or General Supervisor to the HDRL within 3 working days after contractor receipt of the panels, and to the COR within 5 working days.

3.6.4. The contractor shall ensure that qualitative interpretations and final results are reported on each Proficiency Test sample presented.

3.7. SHARP TRAINING. The contractor shall ensure all CSPs receive SHARP training NLT 60 calendar days after contractor personnel begin performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by MEDCOM on an every other month basis by contacting the COR at (210) 221-3713 for class date/time and availability. If contract individuals have an Army Knowledge Online (AKO) account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp.

3.8. NON-GOVERNMENT UNIQUE TRAINING. To avoid competing with commercial sources that provide non-MEDCOM unique training, also known as commercially available training, non-MEDCOM unique training shall not be provided to contractor personnel under this contract. If the contractor arranges for non-MEDCOM unique training for its personnel from any Government source, all such training will occur in a non-paid status outside this contract, with the Government source providing the non-MEDCOM unique training being responsible for collecting all required costs associated with providing the non-MEDCOM unique training to the contractor's personnel.

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES. The contractor shall furnish all materials, supplies, equipment, facilities and services required to perform work under this contract that are not listed under section 3 of this PWS.

4.1. FACILITIES. The contractor shall provide and maintain the necessary facilities to maintain the safety and security of personnel, equipment, and data, and to perform services under the terms of this contract to include:

4.1.1. Facilities sufficient for inventory, collating, preparing, and storing of supplies for shipment to each SA.

4.1.2. Facilities sufficient to properly access, process, and store specimens obtained from all SAs for initial testing within a maximum of 24 hours after receipt.

4.1.3. Facilities sufficient for onsite, secured temperature controlled storage of negative samples until shipped to the DoDSR and secured temperature controlled storage of reactive serum samples and/or plasma samples pending shipment to HDRL.

4.1.4. Facilities sufficient to store reagents/kits utilized to test specimens.

4.1.5. Facilities sufficient to process, reproduce, collate, and store (under secure, limited-access conditions) required reports containing Privacy Act and protected health information.

4.1.6. Facilities sufficient to use, maintain, and monitor computer data processing equipment.

4.2. LABORATORY CERTIFICATION AND QUALITY MANAGEMENT PROGRAM. The contractor shall maintain a complete Quality Management System (QMS) and shall follow CLSI (formerly NCCLS) formats, e.g., CLSI QMS01-A4, Quality Management System: A Model for Laboratory Services, that shall ensure the requirements of the contract are provided, including but not limited to those as specified in Section 4 of the PWS. Within 15 calendar days of contract award the contractor shall submit to the COR an electronic, searchable copy (preferably in Microsoft Office format) of a comprehensive written QMS, and within 5 working days when changes are made thereafter.

4.2.1. As part of the Quality Management Program, the contractor shall ensure all internal lab work sheets, record copies, and copies of reports and transmitted results, required under the terms of this contract, are maintained throughout the contract period and in accordance with regulatory requirements.