B.01. DRAFT SOW- Serological_Automated_Analyzers.pdf

DRAFT

STATEMENT OF WORK

Contents

1. INTRODUCTION

2. BACKGROUND AND PURPOSE

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. COMPLIANCE DOCUMENTS

9. OTHER TERMS, CONDITIONS, AND PROVISIONS

10. ATTACHMENTS

DRAFT STATEMENT OF WORK (SOW)

Title: Serological Automated Analyzers Indefinite Delivery, Indefinite Quantity (IDIQ) Contract

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Diagnostics and Countermeasures Branch (DCB)

1. INTRODUCTION:

The Walter Reed Army Institute of Research (WRAIR) provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. service members, along with threats anticipated during future operations.

Through both times of peace and war, infectious diseases have killed, sickened, and disabled far more service members than bombs and bullets. WRAIR has created a model of vaccine and therapeutic development that is unique, nimble, and responsive to dynamically evolving infectious disease threats of military importance. WRAIR, with its unparalleled expertise, facilities, and international network, has developed many vaccines and drugs in use today by military and civilian medicine around the globe.

In addition to protecting against infectious disease threats, WRAIR conducts basic and applied research that promotes psychological resilience, enhances neurological functioning, and improves operational readiness among U.S. service members. By using a continuum of research from basic science to applied field studies, WRAIR creates innovative solutions to enhance service members’ resilience and recovery.

Research in military psychiatry and neuroscience has been an integral part of WRAIR's portfolio for more than 70 years. WRAIR researchers are recognized leaders in operational medical research for the military in a number of fields, including brain trauma, blast exposure, deployment stressors, and sleep management.

2. BACKGROUND AND PURPOSE:

The primary mission of the Diagnostics and Countermeasures Branch (DCB) is to provide human immunodeficiency virus (HIV) screening and supplemental confirmatory testing for U.S. Army and U.S. Military Entrance Processing Command (MEPCOM) accession candidates, U.S. Army Soldiers and their beneficiaries, and sister services;

the U.S. Navy and U.S. Air Force including Dover Air Force Base, Armed Medical Examiner System, upon request. A second mission is to provide molecular testing services for detection of the HIV for confirmation of the diagnosis of HIV-1 and for monitoring of HIV-1 viral load, hepatitis C virus (HCV) viral load, and HIV-1 Genotype Resistance in HIV-1 infected U.S. Army Soldiers and beneficiaries to allow clinicians to provide appropriate treatment decisions.

The purpose of this requirement is to provide the leasing, installation, and validation of serological automated analyzers with uninterrupted power supply (UPS) backup systems to include all applicable maintenance and repair services. This requirement shall include all applicable reagents, consumables, and instrument preventive maintenance, repair, and re-calibration.

3. SCOPE:

The objective of this requirement is to establish an Indefinite Delivery, Indefinite Quantity (IDIQ) contract upon which orders can be issued for the lease, installation, validation, and user training for serological automated analyzers with UPS backup systems. The Contractor shall also provide all reagents, consumables, and instrument preventive maintenance, repair, and re-calibration of laboratory equipment. In addition, should equipment require relocation from Silver Spring, MD to Fort Detrick, MD, the contractor shall provide services to remove, relocate, install, and calibrate all Bio-Rad equipment supported under this contract.

4. PERIOD OF PERFORMANCE:

Ordering Period 30SEP2025 – 29SEP2030

5. WORK SCHEDULE AND LOCATION:

5.1 Government Facility Office Hours: The Government facility office hours occur between the hours of 0800 and 1800 eastern standard time (EST), Monday through Friday, except U.S. holidays identified in paragraph 5.2 below or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

5.2 U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer (KO). When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

New Year’s Day – January 1st M. L. King Memorial Day – 3rd Monday in January Presidents’ Day – 3rd Monday in February Memorial Day – Last Monday in May Juneteenth – June 19th Independence Day – July 4th Labor Day – 1st Monday in September Columbus Day – 2nd Monday in October Veteran’s Day – November 11th Thanksgiving Day – 4th Thursday in November Christmas Day – December 25th

5.3 Location: 9100 Brookville Road, BLDG 508, Silver Spring, MD 20910. If laboratory equipment relocation is required to Fort Detrick the exact address shall be provided by the Contracting Officer’s Representative (COR) to the Contractor service representative.

6. PERFORMANCE REQUIREMENTS:

The objective of this requirement is to provide the leased serological automated analyzers, installation, and validation with UPS backup systems. The Contractor shall provide all reagents, consumables, instrument preventive maintenance, and re-calibration of leased systems.

6.1 Tasks:

6.1.1 The Contractor shall provide the following leased equipment: (PRS-1)

A. Quantity of 11 - BioRad EVOLIS analyzers, Catalog Number 1314 B. Quantity up to 6 - Geenius confirmatory analyzers, Catalog Number 92052 C. Quantity up to 17 – UPS backup systems

The equipment provided shall meet the Minimum Essential Characteristics as specified in section 6.5 below.

6.1.2 Preventive maintenance and repair, the Contractor shall provide the following support: (PRS-2)

A. Validate all systems to ensure proper operation, upon delivery.

B. Complete Medical Equipment Verification Certification DD Form 2163, with the assistance of the COR, and display form in a prominent place on the equipment.

This form shall be completed annually and replaced as needed. (A.001)

C. Provide on-site training to a minimum of four key operators within DCB.

D. Be prepared to relocate equipment and shift all operations from the WRAIR Forest Glen Annex to Fort Detrick, MD, within 45 days of notification. The Contractor shall provide support for removal, transportation, re-installation, and re-calibration of the instruments in the event of a required change in the instruments’ location.

E. The Contractor shall provide Field Service Engineers (FSE) that are technically trained to repair and maintain the equipment.

F. The Contractor’s representative shall report to or telephonically notify the COR prior to commencing maintenance services during normal operating hours.

G. The Contractor shall provide the Government with a designated point of contact for service inquiries, technical support, and scheduling preventive maintenance or repairs. The Contractor representative shall be available via telephone Monday through Saturday from 0800 to 2300 hours.

H. Preventive Maintenance: The Contractor shall provide semi-annual inspections as recommended by the manufacturer of the equipment. Preventive maintenance shall consist of cleaning, adjusting, lubricating, installing parts and keeping the machine in full mechanical working condition. Preventive maintenance shall be coordinated and scheduled with the COR post award.

I. Emergency Maintenance: The Contractor shall be required to report within 24 hours of initial telephone notification or the next military duty day when unscheduled service is required. If repairs cannot be completed at that time, Contractor shall promptly notify the KO and the COR.

J. The Contractor’s services shall include the cost of consumable parts required for routine maintenance or repairs. The Contractor is not liable for repairs necessitated by fire, water, or the fault/negligence of the Government, nor labor for replacing motors caused by changes in power line specifications.

K. Disposal of Trash and Defective Parts: The Contractor shall be responsible for leaving the work area in a clean and orderly fashion. All defective parts and trash created by the Contractor shall be disposed of appropriately. Contractor shall be responsible for the disposal of all parts.

6.1.3 The Contractor shall provide all reagents and consumables required to perform Combo HIV-1/HIV-2 screening and confirmation testing. (PRS-3)

A. Upon contract award, the Contractor shall include a list of any necessary consumables that is vital to the maintenance and operation of the leased equipment. This list shall include all cost and non-cost items and shall be organized into a list of items provided by the system manufacturer and a list of items not provided by the system manufacturer. This list shall be updated on an as needed basis. (A.002)

B. The Contractor shall provide the required kits to perform Combo HIV-

1/HIV-2 screening tests to cover a total of 480,000 tests per year. The numbers of confirmation tests for HIV are estimated to be 4,000 per year.

All reagents delivered to the Government shall have at least a 90-day shelf life and utilize the same case lot number to the highest extent possible.

C. The Contactor shall sequester the same lot number of reagents for as long a period of time as possible to ensure continuity of reagents and decrease the lot-to-lot conversion.

D. The Contractor shall ship reagents within 24 hours of order and provide overnight shipment upon request. Shipments shall include the contract number on all packages, packing slips, and invoices.

E. The Contractor shall use a shipping method that maintains stability of reagents, if not; replacement of reagents will be provided at no additional cost to the Government.

6.2 On-site Repairs:

6.2.1 Contracted services are to be performed throughout the period of performance of this contract. The Contractor is required to respond within 24 hours of initial telephone notification or the next military duty day when unscheduled service is required.

6.2.2 Prior to reporting to a service call, the Contractor’s service representative shall notify medical maintenance via email (usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil) and shall report in person or telephonically notify the maintenance manager, with building and room number as well as telephone number, prior to commencing services during normal duty operating hours. During other than normal operating hours, the contractor's service representative shall report to the Administrative Officer of the Day (AOD) and notify medical maintenance via email.

(A.003)

6.2.3 The Government and the Contractor's service representative shall exchange hazard communication information before the commencement of any repair.

6.2.4 When required, the Contractor's service representative shall comply with the Occupational Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance on Medical Devices (MDs)/Medical Device Systems (MDSs).

6.2.5 Upon completion of services by the Contractor's service representative, a service report shall be provided to the COR or the AOD and submit an electronic copy of the service report to medical maintenance at usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil. The service report shall provide detailed information regarding the cause of the MD/MDS malfunction and corrective action taken. It shall include, at a minimum, the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with part numbers and prices for each part prior to leaving the facility. Successful performance shall equate to all maintenance tasks are complete, the equipment is operational within manufacturer’s standard and COR/DCB personnel accept the repair and all field service reports and invoices have been received by COR. (A.004)

6.2.6 In the event all information is not available to the Contractor's service representative when services are performed, the initial service report/invoice shall include all available information to close work order within five days. The Contractor shall provide the balance of the required information to the clinical engineering manager no later than ten days after services are completed. (A.004)

6.2.7 The Contractor's service representative shall be factory trained and have a minimum of two years of experience working on the contracted MD/MDS. In addition, services shall be performed by a FSE that is certified by the manufacturer of the equipment. No other FSEs are authorized to work on these instruments.

6.2.8 The Contractor shall furnish all software updates/patches issued by the MD/MDS manufacturer.

6.2.9 The Contractor shall have access to all necessary diagnostic software (if applicable). The Contractor shall use only Original Equipment Manufacturer (OEM) new or OEM refurbished repair parts.

6.2.10 For all contracts that require calibration of systems, the Contractor shall complete DD Form 2163 or DD Form 2164 (Verification/Certification Worksheet) in accordance with the instructions provided in AR 40-61. Additionally, continuation sheet shall be attached to the DD Form 2164 indicating the manufacturer, model, serial number, and date of calibration expiration of all items of test, measurement, and diagnostic equipment (TMDE) used to perform the calibration. Submit an electronic copy of the completed Verification/Certification Worksheet to medical maintenance at usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil and provide a copy to the COR within five days of work completion. (A.001)

6.3 IT Requirements:

6.3.1 Maintain all equipment/product versions provided pursuant to the construction or other procurement contract, to include the supported operating system, by issuing patches/updates to mitigate vulnerabilities [e.g., Information Assurance Vulnerability Alert (IAVA) or Information Assurance Vulnerability Bulletins (IAVB)] and network security configurations [e.g., Defense Information System Agency (DISA) Security Technical Implementation Guides (STIGs)]. The Contractor shall adhere to Defense Health Agency (DHA) guidance for remediation or mitigation of vulnerabilities associated with the equipment/product.

6.3.2 Test all IAVAs, patches, updates, and upgrades in the test/laboratory environment before implementing in a production environment. All production environment IAVAs, patches, updates, and upgrades shall be approved by the WRAIR Change Control Board prior to Contractor implementation. Approved changes shall be implemented on a quarterly basis.

6.4 Consumables List:

Part Number Description Unit 32508 Western Blot 40 tests per kit 12009860 HIV Combo Ag/Ab EIA 960 per kit 72461 Geenius, HIV1-2 20 tests per kit 90433 Evolis Sample Rack Each 72339 Geenius HIV 1-2 Controls 1Pos and 1Neg per unit 933040 Ortho HCV, 4N Sulfuric Acid Solution Each 32594 HBs Ag Confirmation Testing Each 32574 Western Blot Buffer Each 12009911 GS HIV Combo Ag/Ab EIA 4800 Each 26186 MONOLISA Anti-HBc EIA 192 tests per box

25220 MONOLISA Anti-HBs EIA 192 tests per box 32591 GS HBs Ag EIA 3.0 480 tests per box 6195566 Ortho HCV EIA v 3.0 480 tests per box 933730 Ortho HCV Wash Solution Each 32588 GS HIV-1/HIV-2 Plus O EIA 480 tests per box 26179 Extra Waste Container - Evolis Each 25102 Wash + DI Containers – Evolis Each 25260 Stopping Sol HIV 1 per kit 25261 Wash Sol HIV Each 25099 Microcide Disinfectant Each 25115 GSC HBs AG 3.0 Barcode Kit Each 26190 Anti HAV IgM, Monolisa Barcode Kit Each 26225 Conjugate 1, GS HIV Combo Ag/A Each 26227 Conjugate 2 (40 mL) GS HIV Combo Each 31108 GSC HIV-2 Barcode Kit Each 31113 ODS Ortho HCV 3.0 Barcode Kit Each 89611 Tips, Conductive, 300ul, Evolis Case 89612 Tips, Conductive, 1100ul, Evolis Case 89799 Waste Bag, Evolis 10 bags per pack 0210-00 Plate Sealers 40 per pack, 25 per pad 25064A BC Kit, HIV Combo Ag/Ab BV SW5 Each 25278 Barcode Kit, ELITE User Control Each 25221B Vial Microtube 2mL PP 500 per bag 0900-05 Null Strips 5 plates per package 26234 Combo barcodes pack for Elite/Evolis Each 25163 GSC HBs AG 3.0 Confirmatory Barcode Kit Each 25199 Bio-Rad HSV IgG Test Barcode Kit Each 25219 Monolisa Anti-HBs Calibrator Kit Each 89897 Evolis Performance Evaluation Kit Each 12013142 Sarstedt V-Vials with Caps 500 per case 25280 Anti-HBs EIA Barcode Kit Each 26184 Monolisa Anti-HBc Barcode Kit Each 26189 Anti-HAV, Monolisa Barcode Kit Each 89935 Evolis Wash Container (w/o cap) No Tube Assembly Each 89649 Evolis System Fluid Container Each 89780 Evolis Reagent Rack 2, CTRL Each 89679 Evolis Assy, Plate Carrier A1 Each 93262 Evolis Plate Holder, Alu Tape x4 Each 89935 EVOETP Bottle 2L, Wash Buffer w/o Cap Each

6.5 Minimum Essential Characteristics (MEC):

6.5.1 Serological Automated Analyzers:

A. Specimen and reagent mechanisms that involve the use of a single independent processing system for each unique specimen and reagent;

thus, preventing cross contamination between specimens and/or reagent reservoirs. The mechanism may include a multiple channel but shall be an independent process system.

B. Sampling system which auto-detects specimen volume integrity as well as loss of integrity of the pressure gradient for any independent processing unit.

C. Shall be capable of performing high-volume testing with minimal personnel intervention (staffing must be able to load analyzer, then walk away). To enable workflow efficiency and minimal processor staffing initial run set-up must be equal to or greater than 700 samples per analyzer with the ability to continuously load specimens and walk away. Shall have capability to perform up to 1,600 samples within an 8 hour period, 6 days per week.

D. Shall have the capability to perform testing from an 8.5 mL 16x100 mm serum separation tube (SST).

E. Shall have the capability of performing testing on grade 4+ (gross) hemolytic specimens.

F. Shall employ fully automated, robotic processing from addition of diluents, samples, incubation, wash steps, and calculation of results with limited operator interaction.

G. Shall have the capability to interface with a variety of Laboratory Information Systems (LIS) such as Labware, and Laboratory Information Management System (LIMS).

H. Power supply shall include conditioner power source which will help to eliminate the fluctuation in power going to the instrument especially during a power failure which could affect the operation of the instrument.

I. Shall not require plumbing or a drainage system or external ventilation of analyzers.

J. Shall be a U.S. Food and Drug Administration (FDA) approved as Class III in vitro diagnostic device or instrument for conduct of an FDA approved 4th Generation HIV-1/HIV-2 screening test.

6.5.2 Confirmation Analyzers:

A. Human immunodeficiency virus (HIV) confirmation analyzer shall be compatible with the Western Blot test system.

B. HIV confirmation analyzer shall have the ability to detect the separate bands of the HIV-1 and HIV-2 virus.

C. Shall be FDA approved for use in confirmation testing for the presence of the HIV virus.

6.5.3 Reagents:

A. Reagents (assay) shall be capable of being run as comparator, anti-HIV-1 antibody assay in a manual test format, or on an open analyzer system.

B. Combo HIV-1/HIV-2 reagents shall have the ability to detect HIV p24 antigen as well at the presence of HIV antibodies.

C. Combo HIV-1/HIV-2 reagent sensitivity shall have the ability to detect the presence of HIV antigen/antibodies within 7-10 days of infection.

D. Shall be capable of shipping reagents on minimum purchase order to cover 10,000 screening test and maximum purchase order of 48,000 screening tests. The kit test size shall be the most appropriate size in order to decrease the storage space required.

6.5.3.1 HIV Confirmation Reagents:

A. Shall have the ability to differentiate between HIV-1 and HIV-2.

B. Shall be compatible with the Western Blot System.

C. Shall be capable of detecting the separate bands of the HIV Virus.

D. Shall have capability to meet the maximum purchase order to cover 500 HIV confirmation tests and minimum purchase order of 200 HIV confirmation tests. The kit test size will be left to the discretion of the vendor.

7. DELIVERABLES:

The Contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the SOW within the description of the deliverable, all deliverables will be made to the COR electronically. (PRS-4)

Deliverables Table:

Number SOW Ref. Title/Description Due A.001 6.1.2,

6.2.10 Medical Equipment Verification/Certification Worksheet DD Form 2163

Annually and replaced as needed.

Send electronic copy to Medical Maintenance and COR within five days of work completion.

A.002 6.1.3 Consumables List At time of award and as requested thereafter.

A.003 6.2.2 Medical Maintenance Notification

Prior to reporting to a service/repair call and email.

A.004 6.2.5, 6.2.6 Service Report Initial service report due prior to leaving facility or no later than five days after service is completed if additional information is needed; final report no later than 10 days after service is completed.

A.005 9.5, 9.6, 9.7, 9.8, 9.9

Training Report Due 30 days following contract award, or per combatant command guidance, and annually thereafter.

7.1 Inspection and Acceptance:

The COR is delegated to provide oversight of specific technical, functional and oversight responsiblities, is responsible for inspection and acceptance of all services, incoming shipments, and documents.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the SOW and all terms and conditions of this order, including all modifications.

8. COMPLIANCE DOCUMENTS:

8.1 General Compliance

8.1.1 Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, DoD, Department of the Army (DA), U.S. Army Medical Research and Development Command (USAMRDC), and DHA laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

8.1.2 DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A. Installation Access Control (AE Reg 190-16) B. The Army Physical Security Program (AR 190-13) C. Contractor Identification (AE Reg 27-715) D. U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM

385-1-1) E. Information Assurance (AR 25-2) F. Electromagnetic Compatibility Directive (2004/108/EC) G. Policies and Procedures for Property Accountability (AR 735-5) H. Personal Identity Verification of Contract Personnel (CFR clause 52.204-9) I. Privacy Act of 1974 (Public Law 93-579, as codified at 5 U.S.C. Section 552a) J. Defense Federal Acquisition Regulation K. Medical Logistics Policies (AR 40-61) L. Medical Equipment Verification/Certification (DD Form 2163) M. X-ray Verification/Certification Worksheet (DD Form 2164) N. Occupational Safety and Health Standards, The Control of Hazardous Energy

Lockout/Tagout (1910.147)

9. OTHER TERMS, CONDITIONS, AND PROVISIONS:

9.1 Invoices: Reserved.

9.2 Anti-Terrorism and Operational Security: Reserved.

9.3 Compliance with Relevant DoD, Service, and Institutional Policy Regulations:

The Contractor shall comply with Health Insurance Portability and Accountability Act (HIPAA) and all relevant DoD and U.S. Government regulations for collection, storage, and transfer of sensitive data and protected health information (PHI). In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g., Public Affairs clearance and Operational Security clearance for dissemination).

9.4 Personally Identifiable Information (PII) and Protected Health Information:

The Contractor shall comply with the DHA Procedures, Guidance, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 27 October 2020. The Contractor may access personally identifiable information (PII) in the course of task response to the requirements of this contract, as such the Contractor shall comply with the document entitled “Personally Identifiable Information (PII), PHI, and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with the Defense Federal Acquisition Regulation (DFAR) Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The Contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of HIPAA (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11 (Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C. (Reference (ae)).

9.5 iWATCH/Suspicious Activity Reporting Training:

The Contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training program (training standards provided by the requiring activity antiterrorism officer (ATO)). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within five calendar days of new employees commencing performance, with the results reported to the COR no later than 30 calendar days after contract award. (A.005)

9.6 For Contractors Authorized to Accompany the Force:

The Contractor shall comply with DFARS Clause 252.225‐7040, which applies to Contractor personnel authorized to accompany U.S. Armed Forces deployed outside the U.S. in contingency operations; humanitarian or peacekeeping operations; or other military operations or exercises, when designated by the combatant commander.

The Contractor shall follow antiterrorism/operational security (AT/OPSEC) guidance, and comply with all applicable laws and regulations, pre‐deployment requirements, required training (per combatant command guidance), and personnel data required.

(A.005)

9.7 Threat Awareness Reporting Program (TARP):

Per Defense Health Agency-Administrative Instruction (DHA-AI) 097, Insider Threat Program, Contractor employees with security clearances must receive annual Insider Threat Awareness training within 30 days of initial employment, and refresher training annually either through instructor-led or computer-based training. (A.005)

9.8 For Contractors that do not require CAC, but require access to a DoD facility or installation:

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB), applicable installation, facility, and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

(A.005)

9.9 Anti-terrorism (AT) Awareness Training for Contractor Personnel Traveling Overseas:

U.S. based Contractor employees and associated sub-contractor employees shall receive Government provided area of responsibility (AOR) specific AT awareness training as directed by DHA-AI 078. Specific AOR training content is directed by the combatant commander, with the unit Anti-terrorism Officer (ATO) being the local point of contact. (A.005)

10. ATTACHMENTS:

Attachment 1 - Acronyms List

Attachment 2 – Performance Requirements Summary Matrix

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition AI Administrative Instruction AOD Administrative Officer of the Day AOR Area of Responsibility ATO Anti-terrorism Officer AT/OPSEC Anti-terrorism and Operational Security CFR Code of Federal Regulations COR Contracting Officer Representative DA Department of the Army DCB Diagnostics and Countermeasures Branch DD Department of Defense DFAR Defense Federal Acquisition Regulation DHA Department of Health Agency DISA Defense Information System Agency DoD Department of Defense EST Eastern Standard Time FAR Federal Acquisition Regulation FBI Federal Bureau of Information FDA U.S. Food and Drug Administration FPCON Force Protection Condition FSC Federal Supply Code FSE Field Service Engineer GFE Government Furnished Equipment HCV Hepatitis C Virus HDRL HIV Diagnostics and Reference Laboratory HIPAA Health Insurance Portability and Accountability Act HIV Human Immunodeficiency Virus IA Information Assurance IAVA Information Assurance Vulnerability Alert IAVB Information Assurance Vulnerability Bulletins ID Identification IDIQ Indefinite Delivery, Indefinite Quantity IPT Integrated Product/Process Team IPV Instrument Performance Verification IT Information Technology KO Contracting Officer LIMS Laboratory Information Management System LIS Laboratory Information System MD Medical Device MDS Medical Device System MEC Minimum Essential Characteristics

MEPCOM Military Entrance Processing Command MHS Military Health System MTF Medical Treatment Facility NAC National Agency Check NACI National Agency Check with Inquiries NCIC-III National Crime Information Center Interstate Identification Index OCI Organizational Conflict of Interest OEM Original Equipment Manufacturer OPSEC Operational Security OSHA Occupational Safety and Health Administration PGI Procedures, Guidance, and Information PHI Protected Health Information PII Personally Identifiable Information PM Preventative Maintenance SOP Standing Operating Procedure SOW Statement of Work SST Serum Separation Tube STIG Security Technical Implementation Guides TARP Threat Awareness and Reporting Program TMDE Test, Measurement, and Diagnostic Equipment TSBD Terrorist Screening Database UPS Uninterrupted Power Supply U.S. United States USAMRDC United States Army Medical Research and Development Command U.S.C. United States Code USG United States Government WRAIR Walter Reed Army Institute of Research

ATTACHMENT 2 – PERFORMANCE REQUIREMENTS SUMMARY MATRIX

# SOW Ref. Performance Objective

Acceptable Quality Level

Method of Surveillance

1 6.1.1 The Contractor shall provide the following leased equipment:

A. Quantity of 11 - BioRad

EVOLIS Analyzers, Catalog Number 1314

B. Quantity up to 6 - Geenius Confirmatory Analyzers, Catalog Number 92052

C. Quantity up to 17 – UPS backup systems

98% compliance with SOW requirements. The Government shall receive no more than three Corrective Action Reports (CARs) or similar deficiency reports during the Contractor’s performance of the entire contract. A get-well plan shall be submitted within five business days of identification of deficiency.

Direct COR observation and Corrective Action Reports

2 6.1.2 Preventive Maintenance, Emergency Repair, and Technical Support Service:

For the duration of the lease, the Contractor shall provide service, to include technical support via telephone, unscheduled emergency repairs, and preventive maintenance when required for all leased equipment.

98% compliance with SOW requirements. The Government shall receive no more than three Corrective Action Reports (CARs) or similar deficiency reports during the Contractor’s performance of the entire contract. A get-well plan shall be submitted within five business days of identification of deficiency.

Direct COR observation and Corrective Action Reports

3 6.1.3 Consumable Products:

The Contractor shall provide consumables necessary for the proper functioning of the serological automated analyzers.

98% compliance with SOW requirements. The Government shall receive no more than three Corrective Action Reports (CARs) or similar deficiency reports during the Contractor’s performance of the entire contract. A get-well plan shall be submitted within five business days of identification of deficiency.

Direct COR observation and Corrective Action Reports

4 Paragraph 7 Quality Deliverables

98% compliance with deliverable requirements. The Contractor shall submit all deliverables as instructed per the established schedule (due date) with no need for substantive changes. A revised deliverable shall be submitted within five business days of identification of deficiency.

Direct COR observation

5 Paragraphs 3 - 9

Responsive Customer Service (Business Acumen)

The Government will perform random service sampling (reviews) to gauge the Contractor’s customer service responsiveness and professionalism. The Government will receive no more than three complaints or negative reviews denoting a customer service or business acumen deficiency during the Contractor’s performance of the entire contract. A get-well plan shall be provided within five business days of identification of deficiency.

Random Service Reviews or Receipt of Complaints