Performance Work Statement - Clinical Blood Processing Blanket Purchase Agreement.docx

Department of Defense (DoD) Defense Health Agency (DHA) Performance Work Statement (PWS)

Blanket Purchase Agreement (BPA) for Laboratory Sample Processing for the Walter Reed Army Institute of Research (WRAIR), Center for Military Psychiatry and Neurosciences Research (CMPN)

Contract Number: To be determined (TBD)

PART 1 GENERAL INFORMATION

1.1 Introduction: This contract shall provide non-personal laboratory sample processing support for the Walter Reed Army Institute of Research (WRAIR), Center for Military Psychiatry and Neurosciences Research (CMPN).

1.2 Description of Requirement: The contractor shall provide the personnel, transportation, supervision, non-personal services, facilities, and other items necessary to perform laboratory sample processing support services as defined in this Performance Work Statement (PWS) except for those items specified as Government Furnished Property (GFP) and services. The contractor shall perform to the standards in this PWS.

1.3 Background: Since 1893, WRAIR has been a leader in solving the most significant threats to soldier readiness and lethality such as disease and battle injury. WRAIR’s broad research capabilities afford soldiers the best medical protection and support possible before, during, and after deployment by addressing both longstanding and emerging threats. Though WRAIR’s research is focused on soldier health, its products have important civilian applications responsible for saving countless lives around the world.

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense (DoD) requirements and to deliver life-saving products including knowledge, technology, and medical material that sustain the combat effectiveness of the warfighter. WRAIR headquarters is in Silver Spring, MD, and is the largest biomedical research facility currently serving the DoD. The WRAIR’s Research and Development (R&D) activities reach around the world to include forward laboratories in locations such as the Republic of Georgia, Thailand, and Kenya.

CUI//PROCURE

DHA PWS Template V13 November 16, 2021

CUI//PROCURE

The WRAIR’s vision is to be the premier DoD biomedical research organization that executes constantly relevant, integrated basic research and advanced technology that protects, projects, and sustains the warfighter today, invents global medical solutions for the future, and keeps the warfighter on point for the Nation. The WRAIR hosts three Centers: The Center for Military Psychiatry and Neuroscience (CMPN), the Center for Infectious Disease Research (CIDR), and the Center for Enabling Capabilities (CEC) with efforts ranging from blast induced neurotrauma to infectious disease vaccine development.

Standing at the forefront of safeguarding and enhancing Soldier health, WRAIR created the Division of Neuropsychiatry and Neurophysiology in 1950. In the ensuing decades, that effort grew to become today’s Center for Military Psychiatry and Neuroscience (CMPN).

CMPN is a translational and expeditionary effort to identify and eliminate brain health threats to Soldiers. CMPN investigates and manipulates the relationship between sleep and performance, performs mental health assessments to inform unit Commanders on Soldier mental health needs, and develops and implements resilience trainings. On a parallel track are efforts to identify and treat traumatic brain injury as well as understand the impact of repeated blast exposure.

With more than 3,000 publications, numerous patents, and many products, CMPN is an internationally recognized leader in brain health and mental health, developing evidence-based strategies to diagnose, prevent, and mitigate the psychological demands of war, continuous operations, and brain trauma associated with military service.

1.4 Objectives: The objective of this contract is to establish a Blanket Purchase Agreement (BPA) for clinical laboratory sample processing service with an ordering period of five years.

1.5 Scope: The contractor shall provide non-personal clinical laboratory sample processing services, which includes sample pick-up, sample processing (as specified), provide electronic sample results, and provide access to a digital portal platform for simplified requests and results processing.

1.6 Period of Performance (PoP): The PoP for this contract is as follows:

1.7 Administrative Specifications:

1.7.1 Place of Performance: The majority of work shall be performed off site at the contracted vendor’s certified laboratory facility. The laboratory sample pick-up site is the Government facilities located at 503 Robert Grant Avenue, Silver Spring, MD 20910.

1.7.2 Recognized Federal Holidays: The contractor is not required to perform duties on days designated as Federal holidays by Federal Status, Executive Order, Presidential Proclamation, or Installation Commander. Federal holidays are an exception to regular duty hours. Holidays falling on a Saturday will be observed on the preceding Friday; holidays falling 1.7.3 on a Sunday will be observed on the following Monday. The following is a list of Federal holidays upon which duties are not required to be performed:

· New Year’s Day, January 1st

· Martin Luther King Jr. Day, 3rd Monday in January

· President’s Day, 3rd Monday in February

· Memorial Day, last Monday in May

· Juneteenth Day, June 19th

· Independence Day, July 4th

· Labor Day, 1st Monday in September

· Indigenous Peoples Day, 2nd Monday in October

· Veteran’s Day, November 11th

· Thanksgiving Day, 4th Thursday in November

· Christmas Day, December 25th

1.7.4 Hours of Operation: The contractor is responsible for conducting business Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor shall always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.4.1 Generally, the contractor shall provide coverage Monday through Friday during normal duty hours, which are defined as 0800 – 1800 Eastern Standard Time (EST) with the ability to flex hours on a situational basis to accommodate mission activities that may occur before or after official duty hours.

1.7.5 Emergency Services: RESERVED.

1.8 Contractor Travel: RESERVED.

1.9 Other Direct Costs (ODCs): RESERVED.

1.10 Quality:

1.10.1 Quality Control (QC): The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective performance. The contractor will develop and maintain an effective Quality Control Plan (QCP) to ensure tasks are performed in accordance with this PWS. The QCP, at a minimum, must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction. The comprehensive written QCP shall be submitted to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR) within 15 days after contract award. After initial acceptance of the QCP, the contractor shall re-submit any revised or updated QCP for the CO’s acceptance in writing prior to implementing any proposed changes to the QCP. (A.001 - QCP) 1.10.2

1.10.3 Quality Assurance (QA): The Government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Contractor Onboarding and Safeguarding: RESERVED.

1.12 Contractor Personnel: RESERVED.

1.13 Data Rights: Rights to all technical data (including, but not limited to, documents and materials) and computer software (including, but not limited to, source code) produced under this contract are governed by Defense Federal Acquisition Regulation Supplement (DFARS) clauses 252.227-7013, 252.227-7014, 252.227-7015, and 252.227-7019. Documents and materials produced under this contract may not be used or sold by the contractor without written permission from the CO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.14 Reporting: RESERVED

1.14.1 Non-Disclosure Agreement (NDA): RESERVED.

1.14.2 Government’s Contracting Officer’s Representative (COR): The COR will serve as the primary POC for all activities and issues that arise under this contract. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, and specifications; monitor contractor's performance and notify both the CO and contractor of any deficiencies; coordinate availability of GFP; and provide site entry of contractor personnel. The COR for this contract will be appointed by the CO and a letter of designation issued to the COR, a copy of which is sent to the contractor, stating the responsibilities and limitations of the COR, especially regarding changes in cost/price, estimates, 1.14.3 or delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract. Only the CO has the authority to enact changes to this award.

1.14.3.1 The COR is delegated oversight of specific technical and functional responsibilities to include inspection and acceptance of incoming shipments, documents, and deliverables. Certification by the Government of satisfactory performance is contingent upon the contractor performing in accordance with the performance standards contained in this PWS and all terms and conditions of this contract, including all modifications.

1.14.3.2 Contractor Performance Assessment Reporting System (CPARS): RESERVED

1.14.4 Post Award Conference and Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) subpart 42.5. Additionally, the CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the CO will apprise the contractor of how the Government views the contractor's performance, and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.14.5

1.15 Contractor Identification: RESERVED.

1.16 Contractor Access to Defense Health Agency (DHA) Network(s): RESERVED.

1.17 Personnel Security: RESERVED.

1.18 Organizational Conflict of Interest (OCI):

1.18.1 WRAIR has categorized its requirements into two broad categories, global support and isolated support, for purposes of identifying, avoiding, or mitigating against OCIs in accordance with FAR Subpart 9.5. The categories are defined as follows:

A. Global support: Support which, by its very nature, gives the contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. The support is identified as having a direct impact on the operations of the greater WRAIR enterprise. Support would be characterized by having access to Command-wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands. Mitigation strategies may include avoidance (non-participation) or firewalls between existing personnel and the new requirement.

B. Isolated support: Support with a focused impact on a specific branch, department, or program of WRAIR rather than the WRAIR enterprise. Support can be characterized as having little or no access to procurement sensitive information, other than the immediate requirement, and little chance of follow-on work that can be influenced by the immediate requirement. The contractor shall provide a mitigation plan within five days of identifying actual or potential OCI. (A.003 – OCI Mitigation Plan)

Each WRAIR support solicitation will be designated as falling within one of these defined categories. The applicable OCI category shall be set forth in each award. This requirement is categorized as isolated support.

1.18.2 The purpose of this categorization is to accomplish the following three objectives:

A. To inform prospective offerors that WRAIR presumes that award of a contract in the subject category will give rise to real or apparent OCIs with respect to requirements in the other category or may give rise to an OCI in the same category.

B. To assist current contractors and prospective offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoid or mitigate against OCIs.

C.

D. To ensure that all current contractors and prospective offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

1.18.3 For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all of its support requirements and acquisitions regardless of the cognizant contracting activity (e.g., DHA Contracting Activity (DHACA), General Services Administration (GSA), other agency multiple award schedules, etc.) or the type of contract vehicle used (e.g., Federal Supply Schedule (FSS) order, fair opportunity competitive order under multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) contracts, competitively negotiated awards under FAR Part 15, etc.).

1.18.4 Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive, or proprietary information. Furthermore, contractor participation in more than one area may give rise to a real or apparent loss of contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

1.19 Workplace Safety:

Contractor employees must be able to maintain a safe workplace and comply with occupational health and safety rules and regulations. Contractor employees are required to complete safety (e.g., biosafety, human use) training(s) related to their position and report any infractions of safety procedures to the COR immediately.

1.19.1 The contractor shall ensure compliance with occupational health physicals, examinations, tests (e.g., serologic), or vaccinations required to conduct work in laboratories in support of this PWS.

1.19.2 Occupational Safety and Health Administration (OSHA) 300A log: The contractor shall maintain an OSHA 300A log for all reportable incidents greater than first aid, lost time, lost days, or transfer. The contractor shall provide a quarterly report of all mishaps, regardless of class or reportability. To comply with OSHA Standard Number 1904.32, the contractor shall provide an annual 300A (summary) report to the COR and CO. (A.004 – OSHA 300A Log)

1.19.3 Safety Laws and Regulations: The contractor shall comply with FAR 52.236-13, Accident Prevention (November 1991). This shall include, but is not limited to, the following:

1.19.3.1 Before initiation of work at the job site, an Accident Prevention Plan, written by the contractor for the specific work and hazards of the contract, will be reviewed for acceptance by Government personnel. (A.005 – Accident Prevention Plan)

1.19.3.2 Before beginning each activity involving a type of work presenting hazards not experienced in previous project operations or where a new work crew or subcontractor is to 1.19.3.3 perform work, an Activity Hazard Analysis (AHA) shall be prepared by the contractor performing the work activity. (A.006 - AHA)

1.19.3.4 In addition to other requirements for accident prevention specified in this contract, the contractor shall comply with all Federal and State requirements governing safety and health protection on construction sites and other applicable occupational safety codes.

The contractor shall indicate its plan for compliance considering conditions of the work described by the design, technical proposal, operational activities of the Government or others in the area of the work, identification of the coordinator, and implementation of all other accident prevention provisions of this contract.

1.19.3.5 The contractor shall complete and provide safety notifications required by authorities and provide documented proof to the CO via the COR, no later than five business days from the time such notifications were made. (A.007 – Safety Notification)

1.20 Required Training: RESERVED.

1.21 Compliance with Relevant Department of Defense (DoD), Service, and Institutional Policy Regulations: RESERVED.

1.22 Public Key Infrastructure (PKI) Authentication and Encryption: RESERVED.

1.23 Information Technology (IT) Requirements: RESERVED.

1.24

PART 2

DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: IT and telecommunications services (called D-Services).

2.1.2 Category R: Support (professional/administrative/management) services (called R-Services).

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does not have authority to change the terms and conditions of the contract.

2.1.5 Non-personal services contract: A contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.2 Acronyms:

2.3 Applicable Publications and Instructions:

2.3.1 Where applicable, the contractor’s attention is called to the availability of industry, Federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract. The following is a list of applicable publications and references. This list is not all-inclusive.

a. Public Law 99-234

b. DoDM 6025.18, Implementation of the HIPAA Privacy Rule in DoD Health Care Programs

c. DoDI 6025.18, HIPAA Privacy Rule Compliance in DoD Health Care Programs

d. OSHA Standard Number 1904.32, Annual Summary e.

f. HIPPA of 1996

g. Privacy Act of 1974

h. AR 525-13, Antiterrorism

i. DHA-AI 110, Safeguarding Procurement Sensitive Information

j. DHA PGI 224.90, Personally Identifiable Information (PII), Protected Health Information (PHI), and Federal Information Requirement

k. DoDI 5400.11, DoD Privacy and Civil Liberties Programs

l. AR 530-1, OPSEC

m. 21 Code of Federal Regulations (CFR) 11, Food and Drugs, Electronic Records;

Electronic Signatures

n. 21 CFR 50, Food and Drugs, Protection of Human Subjects

o. 21 CFR 54, Financial Disclosure by Clinical Investigators

p. 21 CFR 56, Food and Drugs, Institutional Review Boards

q. 29 CFR 1910.1030, Labor, Bloodborne Pathogens

r. 29 CFR 1910.1200, Labor, Hazard Communication

s. 29 CFR 1910.132, Labor, General Requirements, Protective Equipment

t. 32 CFR 219, National Defense, Protection of Human Subjects

u. 42 CFR 73.16 Public Health, Select Agents and Toxins, Transfers

v. 42 CFR 493, Public Health, Laboratory Requirements

w. 45 CFR 46, Public Welfare, Protection of Human Subjects, “The Common Rule”

x. 49 CFR 173.199, Transportation, Category B Infectious Substances

y. 49 CFR 171-178, Transportation Requirements

z. 5 United States Code (U.S.C.) 552a, Records Maintained on Individuals

aa. 10 U.S.C. 980, Limitation on Use of Humans as Experimental Subjects

ab. The International Council for Harmonizations (ICH) Guidelines for Good Clinical Practice (GCP) Standards (https://www.ich.org/page/search-index-ich-guidelines)

ac. Dangerous Goods Regulations of the International Air Transport Association (http://www.iata.org/Pages/default.aspx)

ad. DoD 6025.18-R, DoD Health Information Privacy Regulation

ae. DoDI 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and -Supported Research

af. DoDI 6440.02, Clinical Laboratory Improvement Program (CLIP)

ag. AR 70-25, Use of Volunteers as Subjects of Research

ah. DHA-AI 3216.01, Protecting Human Subjects in Research

ai. College of American Pathologists, Guide to CAP Accreditation, November 2025

ii. Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 USC 263a) and its associated federal regulations (42 CFR Part 493)

jj. Code of Maryland Regulations (COMAR) Title 10.10

2.4 Research and Development (R&D) Supplemental Information: RESERVED.

2.5

PART 3

GOVERNMENT FURNISHED PROPERTY (GFP), EQUIPMENT, AND SERVICES

The requiring activity authority has assessed the need for GFP, equipment, and services and determined:

3.1 Services: The Government:

☒ Will NOT provide Government furnished services in support of this contract. As a result, this paragraph is not applicable.

· WILL provide Government furnished services required in support of this contract. These services are described below:

3.2 Facilities: The Government:

☒ Will NOT provide facilities in support of this contract. As a result, this paragraph is not applicable.

· WILL provide facilities in support of this contract. The Government provided facilities are described below:

3.3 Utilities: The Government:

☒ Will NOT provide utilities in support of this contract. As a result, this paragraph is not applicable.

· WILL provide utilities in support of this contract. The Government provided utilities are described below:

3.4 Equipment: The Government:

☒ Will NOT provide equipment in support of this contract. As a result, this paragraph is not applicable.

· WILL provide equipment in support of this contract. The Government provided equipment is described below:

3.4.1 Procurement Integrated Enterprise (PIEE), Government Furnished Property (GFP) Module Application: RESERVED.

3.5 Materials: The Government:

· Will NOT provide materials in support of this contract. As a result, this paragraph is not applicable.

☒ WILL provide materials in support of this contract. The Government provided materials are described below:

The Government will provide collected specimen samples to be collected and processed by the contracted vendor.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The contractor:

· Will NOT provide contractor furnished services in support of this contract. As a result, this paragraph is not applicable.

☒ WILL provide contractor furnished services required in support of this contract. These services are described below:

The contractor shall provide the personnel, transportation, supervision, non-personal services, laboratory facilities, laboratory equipment, and other items necessary to perform laboratory sample pick-up and processing services as defined in this PWS except for those items specified as GFP.

4.2 General: The contractor shall furnish the personnel, transportation, supervision, and other items necessary to perform work listed under Section 5 of this PWS.

4.3 Security Clearance: The contractor does not require personnel security clearance based on currently anticipated projects.

4.4 Materials: The contractor shall furnish the necessary materials and supplies to meet requirements under this PWS, except for those items specified as GFP.

4.5 Equipment: The contractor shall furnish the necessary transportation, laboratory, and workspace equipment required to conduct the requirements of this PWS.

4.6 Facilities: The contractor shall utilize their own facility, laboratory, and workspace to conduct the requirements of this PWS.

The work to be performed under this contract shall be performed off-site at contractor facilities that may be located anywhere in the CONUS.

PART 5 SPECIFIED TASKS

5.1 General: The contractor shall provide laboratory sample pick-up and processing services in support of the WRAIR, CMPN. The contractor shall hold current and maintain the following certificates and credentials. The contractor shall provide proof of specified certificates and credentials within 24 hours of request. (A.008 - Credentials) (PRS – 1)

A. College of American Pathologists (CAP) accreditation certification.

B. Clinical Laboratory Improvement Amendments (CLIA) certificate of accreditation.

C. Medical Laboratory permit.

D. Laboratory Medical Directors Curriculum Vitae (CV).

E. Medical License.

5.1.1. Laboratory Sample Pick-up: The contractor shall pick up laboratory samples upon request from Walter Reed Army Institute of Research, 503 Robert Grant Ave. Silver Spring, MD. Samples shall be picked up during WRAIR business hours as provided in Part 1 of this PWS. Samples shall be picked up the same day as requested. Ensure transport is in accordance with 49 CFR Parts 171-178. Samples shall be stored, transported, and maintained under controlled conditions by the contractor to maintain the integrity, safety, and accountability of the samples during transit. (PRS – 2)

5.1.2. Laboratory Sample Processing: The contractor shall process the laboratory samples as requested. The contractor shall provide a menu of laboratory tests to choose from that the research investigators will add to meet their research objectives. These sample tests may include: (PRS – 2)

5.1.2.1. Required Tests:

A. Complete Metabolic Panel (CMP)

B. Complete Blood Count (CBC) (includes differential and platelets)

C. Gamma Glutamyl Transferase (GGT)

D. Thyroid Stimulating Hormone (TSH) with Reflex to T4, Free

5.1.2.2. Optional Tests:

A. Vitamin D, 25-hydroxy, total, immunoassay B.

C. Calcium D. 25-Hydroxyvitamin D (D2, D3) E. Vitamin D 1,25 Dihydroxy (Calcitriol) F. Parathyroid Hormone (PTH), Intact without calcium

5.1.2.3. Optional Retests: If a sample is damaged, results are out of range, or participant participation is out of the eligibility window any of the tests in sections 5.1.2.1 or 5.1.2.2 may need to be redone and additional results returned.

5.1.3. Laboratory Test Results: Test results shall be provided electronically within 72 hours from sample pick-up. Results shall be uploaded to a secure portal for WRAIR authorized research team members to access. (PRS – 2)

5.1.4. Laboratory Digital Online Portal Access: The contractor shall provide WRAIR, CMPN COR and authorized research team members digital online portal access. The portal shall be capable of placing laboratory requests/orders, looking up the status of submitted samples, and pulling test results. The contractor shall ensure cybersecurity and data security measures are in place to maintain information integrity. The samples shall be listed with the following information:

A. Participant Identification (ID)

B. Date of Birth (DOB)

C. Date of sample collection

D. Sex

E. Clinical site

5.2. Reporting and Billing Management:

5.2.1. The Contractor shall ensure that a Monthly Status Report (MSR) is submitted outlining the laboratory samples processed, billing statement, and any problems/issues encountered in the performance of this task. The MSR shall include but not be limited to: (A.009 – MSR)

A. Activities completed in reporting period.

B. Billing statement.

C. New and ongoing issues/problems.

D. Identified risks and mitigation.

E.

F. Any government action needed.

G. Monthly Performance Metrics.

H. Lessons learned.

5.2.2. The billing shall be processed on a cost basis authorizing Government Purchase Card (GPC) as the standard form of payment.

5.2.3.

PART 6

INFORMATION TECHNOLOGY (IT) AND SECURITY

6.1 All work under this contract is unclassified; however, CUI may be used or generated for projects.

6.2 The level and position sensitivity designation for positions under this contract is TIER II – non-critical sensitive position.

TIER II: Non-critical sensitive position - A position where an individual is responsible for systems design, operation, testing, maintenance, and/or monitoring that is carried out.

6.3 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal Information Requirements: RESERVED.

6.4 Training: RESERVED.

6.5 Cybersecurity Requirements for Non-DoD Information Technology (IT) or Covered Contractor Information System (IS): RESERVED.

6.6 Risk Management Framework (RMF) for DoD Information Technology (IT):

RESERVED.

6.7. Facility Related Control Systems (FRCS): RESERVED.

6.8. System Communications: RESERVED.

6.9 Military Health System (MHS) Demilitarized Zone (DMZ) Medical Community of Interest (MedCOI) Business-to-Business (B2B) gateway: RESERVED.

6.10 Contractor Provided Information Technology (IT) Infrastructure: RESERVED.

6.11 System Authorization Access Request (SAAR) (DD Form 2875): RESERVED.

6.12 Military Health System (MHS) Systems Telecommunications: RESERVED.

6.13 Establishment of Telecommunications: RESERVED.

6.14 Contractors Located on Military Installations: RESERVED.

6.15 Anti-Terrorism (AT)/Operations Security (OPSEC) Requirements:

6.15.1 Anti-Terrorism (AT) Level I Training: RESERVED.

6.15.2

6.15.3 Access and General Protection, Security Policy and Procedures, and Background Checks: RESERVED.

6.15.3.1 Common Access Cards (CAC) and CAC Log: RESERVED.

6.15.3.2 Contractors Requiring a Common Access Card (CAC): RESERVED.

6.15.3.3 Contractors that do not Require a Common Access Card (CAC), but Require Access to a Department of Defense (DoD) Facility or Installation: The contractor and all associated subcontractor 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 a Government representative); or, at OCONUS locations, in accordance with Status of Forces Agreement (SOFAs) and other theater regulations.

6.15.4 Anti-Terrorism (AT) Awareness Training for Contractor Personnel Traveling Overseas: RESERVED.

6.15.5 iWATCH / Suspicious Activity Reporting Training: RESERVED.

6.15.6 Service Training Certification Tracking System (STCTS) Registration for Contractor Employees who Require Access to Government Information Systems (IS): RESERVED.

6.15.7 Operations Security (OPSEC) Program Requirements: RESERVED.

6.15.8 Operations Security (OPSEC) Training: RESERVED.

6.15.9 Cyber Awareness (Information Assurance (IA)/Information Technology (IT)) Training: RESERVED.

6.15.10 Cyber (Information Assurance (IA)/Information Technology (IT)) Certification:

RESERVED.

6.15.11 Contractors Authorized to Accompany the Force: RESERVED.

6.15.12 Anti-Terrorism (AT) / Force Protection for Defense Contractors Outside the United States (U.S.): RESERVED.

6.15.13 Handling of or Access to Classified Information: RESERVED.

6.15.14 Controlled Unclassified Information (CUI): RESERVED.

6.15.15 Threat Awareness Reporting Program (TARP): Per DHA-AI 097, Insider Threat Program, contractor employees with security clearances must receive annual insider threat 6.15.16 awareness training within 30 days of initial employment, and refresher training annually either through instructor-led or computer-based. (A.010 - Training Certificates)

PART 7 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

7.1 Technical Exhibits:

7.1.1 DHA’s Contractor Training Instructions:

DHA FY22 Annual Training List_Oct 2021

7.2 Attachments

7.2.1 Attachment 1: Performance Requirements Summary (PRS)

7.2.2 Attachment 2: Deliverables Schedule

7.2.3

PART 7, ATTACHMENT 1 PERFORMANCE REQUIREMENTS SUMMARY (PRS)

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the performance objectives and Acceptable Quality Levels (AQLs) outlined below.

Reference

PRS - 1

Responsive Customer Support (Business Acumen)

The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

shall be provided within five days of identification of deficiency.

PRS - 2

Pick up and processing of samples.

Paragraph

5.1.1 - 5.1.3 95 percent compliance with the following:

-Samples shall be picked up the same day requested during WRAIR business hours as provided in Part 1 of this PWS.

-Results shall be provided electronically within 72 hours from sample pick-up.

PRS - 3

Quality Deliverables

within five days. of identification of deficiency.

PART 7, ATTACHMENT 2 DELIVERABLES SCHEDULE

All documentation shall be prepared in accordance with standard industry practices with electronically produced documents that reflect logical flow of material, tables of contents, indexes, and page numbering. (PRS – 3)

A.003 – OCI Mitigation Plan Submitted within five days of identifying actual or potential OCI Electronic document (e.g., Word, Excel, PowerPoint, PDF)

A.004 – OSHA 300A

Log

prior to initiation of work at the job site Electronic document (e.g., Word, Excel, PowerPoint, PDF)

subcontractor is to perform the work activity

1.19.3.2

credentials within 24 hours.

thereafter

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