DRAFT - Attachment 1 - Performance Work Statement (PWS) CRLTS - FINAL 20260419.pdf

Department of Defense Health Agency Performance Work Statement

Clinical Reference Laboratory Testing Services

Date: 19 April 2026

PART 1

1.0 GENERAL INFORMATION: This is a non-personal service(s) contract under which the personnel rendering the service(s) 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.

1.1 This is a non-personal services contract to provide Clinical Reference Laboratory Testing Services.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform clinical reference laboratory testing services as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: Clinical reference laboratory testing includes comprehensive support generally encompassing the American Medical Association’s Current Procedural Terminology (CPT) coding within the ranges of 80047- 89398, 90281-99607, 99091-99499, 0002M-0020M, 0042T-0900T, and 0001U-0520U. They include, but are not limited to, support across multiple clinical and anatomic pathology disciplines to include chemistry, hematology and coagulation, urinalysis, transfusion medicine, microbiology, molecular, histology, cytology, and genetic testing. Physicians use laboratory results to provide information about an individual’s medical condition, and confirmation or exclusion of possible illnesses or disorders. The Government requires performance of commercial reference laboratory testing services for tests currently not supported by in-house DoD testing capabilities or capacity. Requested testing is typically for low volume, high complexity, high cost and/or specialized esoteric testing. Generally, this type of testing has not been brought in-house as it would be cost-prohibitive or inefficient in most cases. Additionally, a significant portion of these are categorized by the United States Food and Drug Administration (FDA) as Laboratory Developed Tests (LDT), i.e., not FDA approved; and are therefore not commercially available outside of the laboratory that developed/validated the assay.

1.4 Objectives: The contractor must be capable of providing comprehensive reference laboratory support which includes all unique, individually orderable tests and panels listed in Exhibit A, Price List and Required Schedule of Tests, across all the aforementioned disciplines. The contractor must possess an infrastructure to fully support the receipt, transport, processing, testing, and reporting of results for the total projected annual requirements across all agencies as defined in PWS Attachment 8 – Performance Requirements Summary. Order and results will be transmitted via the Contractor’s Laboratory Information System (LIS) and MHS Genesis.

1.5 Scope: The Contractor shall provide non-personal service(s). Services include clinical reference laboratory testing services to the government at Contiguous/Continental United States (CONUS) and Outside the Contiguous/Continental United States (OCONUS). Clinical reference laboratory testing services will support the Defense Health Agency (DHA) and other Government agencies.

1.5.1 All tests shall be executed at the Contractor’s premises, or within the Contractor's network of approved laboratories.

1.5.2 The DHA Contracting Officer’s Representative (COR) is the focal point for this requirement. Each submitting activity will have their own Alternate Contracting Officer’s Representative (ACOR). In the event of conflicting guidance, the direction provided by the DHA COR shall take precedence.

1.5.3 At a minimum, the contractor will provide specimen processor(s) to DoD sites sending more than 2,000 specimens and expending more than $30,000 per month for reference lab testing. The current number of sites that fall within these criteria is approximately 16 MTFs, CONUS, and OCONUS, but may increase or decrease over the life of the contract. The current locations that meet this criteria are listed below:

1.5.4 The contractor will determine a staffing formula for those sites ensuring that specimens are sent out the same day or the next business day. (Required for those sites that send out numerous specimens or requiring manual processing i.e., miscellaneous testing).

1.5.5 The Contractor will have a phase-in period to comply with all requirements and achieve full testing performance. Contractor will provide a phase in plan detailing high-level timelines and major milestones and how requirements will be met, within 14 days of award. This plan will be expanded into a comprehensive Integrated Master Schedule that governs all activities during the six-month transition period defined in PWS 1.6.1. Contractor must be compliant with the current Cyber Security Model Maturity Certification (CMMC) Final Level 2 (Self) as a condition of this contract award.

1.6 Period of Performance (PoP): The period of performance for the base single-award indefinite delivery/indefinite quantity contract consists of a five-year base ordering period and a potential five-year optional period for a total of ten years.

1.6.1 Transition: Transition-in/transition-out period. If award is made to a non-incumbent contractor, a transition-in period of up to six-months will be required at the start of the contract. In this scenario, the five-year base ordering period shall commence immediately following the successful completion of the transition. If award is made to the incumbent contractor, no transition-in period will be required. In this scenario, the five-year ordering period shall commence on the contract start date specified in the notice of award.

1.6.1.1 Transition-in period: T he Contractor will have up to a six-month transition period to comply with all requirements to accomplish full performance by the start date specified in the Task Order schedule. During the transition-in period, the contractor shall prepare to meet all contract requirements and tasks within this PWS to include:

1.6.1.2 achieve full testing performance, to include completion of their Laboratory Information System (LIS)

MTF Location Average Tests Per Month

Naval Hospital Camp Pendleton Camp Pendleton, CA 92055 (San Diego) 7,334

Naval Base San Diego San Diego, CA 92136 18,325 Brian D. Allgood Army Community Hospital

Camp Humphreys, South Korea 2,573

Walter Reed National Military Medical Center

Bethesda, MD 20889 9,668

Brooke Army Medical Center Ft Sam Houston, TX 78234 (San Antonio) 4,025 Naval Medical Center Portsmouth Portsmouth, VA 23708 10,024 Tripler Army Medical Center Tripler AMC, HI 96859 (Honolulu) 5,812 Womack Army Medical Center Ft Bragg, NC 28310 (Fayetteville) 5,352

Madigan Army Medical Center Joint Base Lewis-Mchord, WA (Lakewood) 98431 2,527 Alexander T. Augusta Military Medical Center

Ft. Belvoir, VA 22060 (Washington D.C.) 5,615

Carl R. Darnall Army Medical Center Ft. Hood, TX 76544 (Killeen) 7,744 William Beaumont Army Medical Center Ft. Bliss, TX 79906 (El Paso) 2,859 Landstuhl Regional Medical Center Landstuhl / Kirchberg, Rhineland-Pfalz, 66849 (Germany) 2,477 Evans Army Community Hospital Ft. Carson, CO 80913 (Colorado Springs) 3,767 Naval Hospital Jacksonville Jacksonville, FL 32214 2,455 Naval Hospital Camp Lejune Jacksonville, North Carolina 28547 4,937 and interface

1.6.1.3 complete a build of laboratory test file and tables

1.6.1.4 complete onboarding and functional training of all qualified specimen processing personnel

1.6.1.5 ensure remaining personnel are trained and qualified within 14 days of their start date.

1.6.1.6 ensure all cybersecurity requirements are fully adhered to during transition and full performance periods.

1.6.2 Transition-out period

1.6.2.1 The contractor shall continue full performance for up to six months

1.6.2.2 Cooperate with the incoming contractor to transfer data, processes, and knowledge to facilitate a smooth transition for staff by allowing them to interview with the successor contractor.

1.6.2.3 Outgoing contractor will remove contractor items, and clean the area they utilized within the MTF to process specimens being sent to the contractor In Accordance With (IAW) established safety requirements

1.6.2.4 Develop a clear plan for managing any samples that are in transit at the time of the handover to ensure they are received and processed correctly by the incoming contractor.

1.7 Administrative specifications

1.7.1 Place of performance: Testing shall be performed at the contractor’s facilities and/or contractor’s affiliated laboratories.

1.7.2 Recognized Federal holidays: Work shall not be performed by contractor provided specimen processors on U.S federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer (CO). 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 Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business 24 hours a day, 7 days a week, 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 must always maintain an adequate workforce for the uninterrupted performance of all tasks defined in this PWS when the Government facility is not closed. Contractor is required to support an activation or exercise of contingency plans outside the normal duty hours. Support during contingency plans is limited to providing unscheduled STAT courier services and prioritizing the testing of designated specimens IAW the procedures outlined in section 5.3.5.2.

1.7.4 Emergency Services:

1.7.4.1 The contractor program manager shall be available Monday through Friday 0800 through 1700 hrs in their respective region. The contractor representative (CR) shall be able to contact the program manager at any time if an issue needs to be escalated to that level.

1.7.4.2 The contractor shall provide a CR to resolve any technical issues and/or problem areas the customers experience in the field. Refer to paragraph 5.4.3 of this PWS for CR responsibilities.

1.8 Contractor Travel: RESERVED

1.9 Other Direct Costs (ODC): RESERVED

1.10 Quality

1.10.1 Quality Control (QC): The Contractor shall provide a copy of its existing Quality Management Plan (QMP) and QC program to the DHA COR within 15 days after contract award. The contractor shall develop and maintain an effective QC program to ensure services are performed IAW this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is how the work complies with stated requirements.

1.10.1.1 The contractor shall implement and maintain, throughout the life of the contract, a Quality Management Plan (QMP) and QC program to ensure services are performed IAW this PWS and to ensure compliance with the Clinical Laboratory Improvement Amendment of 1988 (CLIA) and College of American Pathologists (CAP).

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 .

1.10.1.2 The Contractor’s Proposed Quality Control Program (QCP) shall be submitted to DHA through the Contracting Officer’s Representative (COR) for approval within 15 days after date of contract award.

1.10.1.3 The government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor. If the Government has provided comments, the Contractor shall then have 10 days to submit a Final QCP. After receipt of the Final QCP, the Contractor must receive acceptance by the COR in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the CO no later than 15 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP shall address the following:

1.10.1.3.1 A chart showing the organizational structure and lines of authority, the names, contact information, and job title of each member of the Contractor’s QC Team.

1.10.1.3.2 How the Contractor will monitor work to ensure performance complies with all deliverables (etc.

timelines, deadlines, and goals);

1.10.1.3.3 How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses.

1.10.1.3.4 How the Contractor will monitor and ensure staff qualifications remain current and valid including DoD Contractor Personnel Office processes/approvals throughout contract performance.

1.10.1.3.5 How the contractor will inventory and track maintenance of all Government Provided Equipment/Materials.

1.10.1.3.6 How the contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

1.10.1.4 How the contractor shall provide, upon request, to the DHA COR, the following documentation:

1.10.1.4.1 Quality Assurance (QA) policies.

1.10.1.4.2 QC results for assays.

1.10.1.4.3 On-going calculations of QC performance (coefficient of variation, mean and standard deviation).

1.10.1.4.4 Monthly Levy-Jennings graphs.

1.10.1.4.5 Documentation of appropriate analyzer maintenance.

1.10.1.4.6 Verification results for assays of non-regulated analytes.

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html

1.10.1.4.7 Verification results for analytes for which proficiency testing does not currently exist.

1.10.1.5 The contractor shall inform the COR in writing on issues or potential issues that might affect the performance within 12 clock hours of identifying those issues.

1.10.1.6 The contractors shall implement and sustain a QMP and QC Program with records that are complete and accurate throughout the life of the contract.

1.10.1.7 The Contractor shall perform external proficiency testing surveys required by CLIA for all regulated analytes. The Contractor shall provide the DHA COR a listing of external proficiency surveys that the laboratory participates IAW CLIA requirements. Survey results and statistical reviews for specific laboratory specialties shall be provided to DHA COR upon request.

1.10.1.8 Commercial test methods shall be United States FDA approved. LDTs and other non-FDA approved methods require a documented validation plan that complies with all relevant guidelines from CLIA, CAP, the Clinical and Laboratory Standards Institute (CLSI), and the Code of Federal Regulations (CFR). All validation documentation must be made available to the DHA Contracting Officer's Representative (COR) upon request.

1.10.1.9 Upon DHA COR request, the Contractor shall provide CAP interim checklist reports and CAP inspection reports to include deficiencies and corrective actions within 14 days of receiving the report. The Contractor shall submit to the DHA COR notification of completion of corrective action.

1.10.1.10 After acceptance of the QCP the contractor shall receive the COR’s acceptance in writing on any proposed change to the QC system

1.10.2 Quality assurance: The government will evaluate the contractor’s performance under this contract IAW 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 IAW 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 personnel

1.11.1 CAC requirements: A Common Access Card (CAC) is the standard identification for eligible DoD contractor personnel. For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA Form 33 Request for Common Access Card, current version (PWS Attachment 5).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements: Refer to PWS Attachment 6.

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property provided for contractor use.

1.11.4 Key control: Reserved.

1.11.5 Lock combinations: Reserved.

1.12 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 am to 5:00 pm Monday through Friday local time of the primary supported region except Federal holidays or when the government facility is closed for administrative reasons.

Qualifications for all key personnel are listed below:

1.12.1 Contract Manager and Alternate Contract Manager: The contractor shall provide the CV of the Contract

Manager and Alternate Contract Manager. To minimize Government involvement with contract management, experience with laboratory contracts is preferred but not required.

1.12.2 Quality Manager or Quality Control Manager and Alternate must demonstrate a minimum of the current CLIA qualifications as a General Supervisor within the past ten (10) years, working in Quality Management.

1.12.3 The Contractor shall ensure that all Contractor personnel providing testing services meet the following requirements: The Contractor shall not employ any individual to provide direct health care services who is listed on the Health and Human Services (HHS) list of providers excluded from Federally funded health care programs. The list is found at http://oig.hhs.gov/fraud/exclusions.asp.

1.12.3.1 Contractor personnel shall not have been convicted of a felony.

1.12.3.2 Contractor personnel shall successfully complete a criminal history background check IAW paragraph 1.15 of the PWS.

1.12.3.3 Contractor personnel shall be able to read, write, and speak English well enough and enunciate with sufficient clarity to effectively communicate with patients and other providers.

1.12.3.4 CSPs are required to meet Continuing Medical Education requirements as determined by their accrediting organization and/or state.

1.12.3.5 CSP shall have skills, knowledge and experience to perform the specific tasks (see Paragraph 5 of this PWS) listed for their specialty.

1.12.3.6 Contractor and CSPs shall abide by all standards, rules, and procedures including requirements for licensure, credentialing, and QA programs IAW CLIA and credentialing agency.

1.12.3.7 CSP shall be required to take and maintain in a current status, any on-going training as required by regulation, command directive, state law and/or any other inspecting entity.

1.12.3.8 CSPs exhibit competency in the application of microcomputers, data processing operations, relational database software, spreadsheet software, word processing applications, and current operating systems.

1.13 The Government has rights to all deliverables, such as reports and documents, that are created at the Government expense under this contract. For software, this applies only to custom software, scripts, or code newly developed exclusively for the Government under this contract. It does not apply to the contractor's pre-existing or commercially available software, including its proprietary LIS and any modifications or interfaces thereto. All materials supplied to the Government shall be the sole property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government and will not be used for any other purpose. These documents and materials will not be used or sold by the Contractor without written permission from the CO.

1.14 Reporting:

1.14.1 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance;

maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

http://oig.hhs.gov/fraud/exclusions.asp

1.14.2 Post award conference/periodic progress meetings: The contractor agrees to attend a post award conference requested by the contracting office. The CO and COR shall meet periodically with the contractor to review the contractor's performance. At these meetings the COR 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.

1.14.2.1 During the Transition In period, the Contractor shall attend a monthly teleconference to discuss and provide a progress report on the 5th of each month with DHA COR. The report and discussion will include progress and issues on the efforts to achieve the required electronic interfaces to ensure secure electronic data transfer capability until it is complete. The Contractor must have the ability to electronically transfer data correctly upon commencement of full performance. Refer to paragraph 1.6.1 of this PWS.

1.15 Contractor Access to Health Affairs (HA)/DHA Network(s):

1.15.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system. Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation. These forms can be found at https://www.opm.gov/forms/pdf_fill/sf85.pdf and https://www.opm.gov/forms/pdf_fill/sf86.pdf respectively.

1.15.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

1.16 Personnel Security:

1.16.1 The contractor shall comply with the following: DoDM “Cyberspace Workforce Qualification and Management Program, dated 15 Feb 2023, DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM 5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020.

1.16.1.1 Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements: Follow the DHA Personnel Security Office guidelines for the submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.16.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.16.1.3 DHA Personnel Security Office does not deny any access to any automated information system, network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

https://www.opm.gov/forms/pdf_fill/sf85.pdf https://www.opm.gov/forms/pdf_fill/sf86.pdf

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

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

2.1.2 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), 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.

2.1.3 Nonpersonal 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.

2.1.4 Quality Assurance Surveillance Plan: An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government will require the offerors to submit a proposed QASP for the Government’s consideration in development of the Government’s plan.

2.1.5 Day: means, unless otherwise specified, a calendar day.

2.1.6 Defective Service: means a service output that does not meet the standard of performance associated with the

PWS.

2.1.7 Deliverable: means anything that can be physically delivered but includes non-manufactured things such as meeting minutes or reports.

2.1.8 Physical Security: means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

2.1.9 Quality Assurance: (or Government contract QA) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

2.1.10 Quality Control: means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11 Statement: means the specific results-based activities required to satisfy High Level Objectives. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however, they are not prescriptive in describing “how” the outcome is to be achieved. HLO’s have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

2.1.12 Subcontractor: means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

2.1.13 Work Day: The number of hours per day the Contractor provides services IAW the contract.

2.1.14 Work Week: Monday through Friday, unless otherwise specified.

2.1.15 Accreditation: The formal approval by the DHA to operate the contractor's IS/networks in a particular security mode using a prescribed set of safeguards at an acceptable level of risk. In addition, accreditation allows IS/networks to operate within the given operational environment with stated interconnections, and with appropriate level of protection for the specified period.

2.1.16 Certification: 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 counter measures required for each system/network.

2.1.17 Contract Service Personnel/Provider (CSP): An employee of the Contractor, subcontractor and/or subcontractor personnel or providers. (i.e., Contractor representative, customer service personnel, data entry/specimen processing technician, and courier)

2.1.18 Current Procedure Terminology (CPT): A listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians.

2.1.19 Etiological Agent: Infectious agents as defined by 42 CFR Part 72.

2.1.20 Laboratory Developed Test (LDT): An in vitro diagnostic test that is manufactured by and used within a single laboratory.

2.1.21 Logical Observation Identifier Names and Codes (LOINC): The LOINC Laboratory terms set provides a standard set of universal names and codes for identifying individual laboratory and clinical results. LOINC Codes allow users to merge clinical results from many sources into one database for patient care, clinical research, or management.

2.1.22 Medical Expense and Reporting System (MEPRS) Code: An ordering code (three to four alpha-numeric characters) that identify the sub-specialty within the hospital to charge expenses. As an example, code AAAA, is charged to Inpatient Internal Medicine Services.

2.1.23 MHS Genesis: The electronic health record (EHR) for the Military Health System (MHS), provides enhanced, secure technology to manage your health information. MHS GENESIS integrates inpatient and outpatient solutions that will connect medical and dental information across the continuum of care, from point of injury to the MTF. This includes garrison, operational, and enroute care, increasing efficiencies for beneficiaries and healthcare professionals.

2.1.24 Medico-Legal: of or relating to both medicine and law.

2.1.25 Quality Assurance Program (QAP): All necessary measures taken to assure that the quality of an end product or service shall meet contract requirements.

2.1.26 Shipping Form: Form(s) used to initiate shipping actions.

2.1.27 Specimen: A quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes.

2.1.28 STAT: Immediately

2.1.29 Submitting Activity (SA): Any Government activity submitting specimens under this contract.

2.1.30 Submitting Activity Contracting Officer (SA CO): Contracting Officer who issues an individual task order against the ID/IQ contract, other than the CHCC/CO

2.1.31 Transfer Tube: Any tube used to collect, transport, transship, and store samples under terms of the PWS.

2.1.32 Trusted Associate Sponsorship System: Web-based system which replaces the Contractor Verification System (CVS)

2.1.33 Turn Around Time: The time from when a testing facility receives a specimen to the time the specimen is resulted in the IS.

2.2 Acronyms:

B2B Business-2-Business CAC Common Access Card CAP College of American Pathologists CDRL Contract Data Requirement List CFR Code of Federal Regulations CLIA Clinical Laboratory Improvement Amendments of 1988 CLMS Center for Laboratory Medicine Services CLSI Clinical Laboratory Standards Institute CMMC Cybersecurity Maturity Model Certification CNSSI Committee on National Security Systems Instruction CO Contracting Officer(s) CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative CPT Current Procedure Terminology CSP Contract Service Personnel CUI Controlled Unclassified Information DD Form 254 Department of Defense Contract Security Requirement List (if applicable) DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DSAA Data Sharing Agreement Application DMDC Defense Manpower Data Center DoDM Department of Defense Manual DPCLO DHA Privacy and Civil Liberties Office eMSM Enhanced Multi-Service Markets FDA [United States] Food and Drug Administration FRCS Facility Related Control Systems FSO Facilities Security Officer GFP Government Furnished Property HIPAA Health Insurance Portability and Accountability Act HHS Health and Human Services IA Information Assurance

IATA International Air Transport Association IAW In Accordance With ID Identification IT Information Technology LDT Laboratory Developed Test LIS Laboratory Information System LOINC Logical Observation Identifier Names and Codes MHS Military Health System MTFs Military Treatment Facilities NIST National Institute of Standards and Technology OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPM Office of Personnel Management OPSEC Operations Security PHI Protected Health Information PII Personally Identifiable Information POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan SF Standard Form SPRS Supplier Performance Risk System MEPRS Medical Expense and Reporting System NACLC National Agency Check with Law Enforcement and Credit SA Submitting Activity SA COR Submitting Activity Contracting Officer Representative SHARP Sexual Harassment/Assault Response and Prevention TARP Threat Awareness & Response Program TAT Turn Around Time

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

2.3.1 Department Of Defense Contract Security Classification Specification (DD Form 254)

2.3.2 Department of Defense Security Agreement (DD Form 441)

2.3.3 National Industrial Security Program Operating Manual (DoD 5220.22-M)

2.3.4 Information Assurance Workforce Improvement Program (DoD 8570-M)

2.3.5 Information Assurance Training Certification and Workforce Management Directive (DoDD 8570.01)

2.3.6 Committee on National Security Systems (CNSS) Glossary”, 6 April 2015

2.3.7 CNSSI No. 1253 “Committee on National Security Systems (CNSS) Instruction No. 1253, Security Categorization and Control Selection for National Security Systems, 27 March 2014

2.3.8 DoD Manual 5200.2, DoD Personnel Security Program (PSP)

2.3.9 DoD 6025.18-R, “DoD Health Information Privacy Regulation”

2.3.10 DoD Instruction 8520.02, Public Key Infrastructure and Public Key Enabling\DoD

Instruction 8551.1, Ports, Protocols, and Services Management

2.3.11 DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs

2.3.12 DoD Instruction 6025.18, Privacy of Individually Identifiable Health Information in DoD Health Care Programs

2.3.13 DoD Directive 5400.11, DoD Privacy Program

2.3.14 DHA Memorandum “Update-Risk Management Framework for Medical Community of Interest Migration”, 2 May 2017

2.3.15 DHA Administrative Instruction 77, “Security Categorization (SC) and Control Selection for Information Technology (IT)”, 28 May 2015

2.3.16 Federal Information Processing Standard (FIPS) Publication 199, “Standards for Security Categorization of Federal Information and Information Systems”, February 2004

2.3.17 FIPS Publication 200, “Minimum Security Requirements for Federal Information and Information Systems”, March 2006

2.3.18 FIPS Publication (FIPS PUB) 140-2, Security Requirements for Cryptographic Modules

2.3.19 FIPS PUB 201-2, Personal Identity Verification of Federal Employees and Contractors

2.3.20 NIST SP 800-30, “Guide for Conducting Risk Assessments”, Revision 1. September 2012

2.3.21 NIST SP 800-37 Revision 1, “Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach”, February 2010

2.3.22 NIST SP 800-39, “Managing Information Security Risk: Organization, Mission, and Information System View”, March 2011

2.3.23 NIST SP 800-53 “Security and Privacy Controls for Federal Information Systems and Organizations”, Rev 4, April 2013

2.3.24 NIST SP 800-53A Revision 4, “Assessing Security and Privacy Controls in Federal Information Systems and Organizations”, December 2014

2.3.25 NIST SP 800-60 Volume 1 Revision 1, “Guide for Mapping Types of Information and Information Systems to Security Categories”, August 2008

2.3.26 DODI 1400.25, “Civilian Personnel Management”

2.3.27 DODI 2000.16 “DoD Antiterrorism Program”, 8 May 2017

2.3.28 DODI 8582, “Security of Non-DoD Information Systems Processing Unclassified

2.3.29 Nonpublic DoD Information”, 09 December 2019.

2.3.30 Local regulations as deemed appropriate by the Information Assurance (IA) Officer specified at the task order level.

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government: Provide biologic specimens that have been collected and processed (centrifuged, separated, labeled, and preserved) per the Contractor’s published specimen collection requirements, and IAW standard quality procedures.

☒ WILL provide Government Furnished Services required in support of this contract/task orders these services are described below:

3.1.1 Perform specimen collection.

3.1.1.1 Order required tests in MHS Genesis or other LIS, when available, and provide the Contractor with test requests, lists, or work documents with required patient demographics and ordering information. Once the lab test file is interfaced, the Government will not complete additional Contractor forms, data entry, or test requisitions in the Contractor’s automated laboratory system. For each test requisition, Government personnel will provide:

• Patient’s full name.

• Department of Defense Identification (DoDID) Number or Unique Patient Identifier.

• Submitting Activity’s Name and Accession Number.

• Date of Specimen Collection.

• Date Specimen Shipped.

• Test(s) Requested/Code and Name.

• Specimen Type.

• Ordering Physician’s Name.

• Ordering Remarks/Comments (if clinically appropriate).

• Patient’s Age or Date of Birth.

• Patient’s Sex.

• Submitting Activity Site.

• Submitting Activity Site Account Number.

3.1.1.2 Specimens for testing

3.1.1.3 If onsite CSPs are provided, The Government will provide workspace sufficient to accommodate the required on-site contractor personnel, including desk space, storage for supplies, and access to required utilities.

3.2 Facilities: The Government

☒ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below:

3.2.1 The Government will provide sufficient workspace, to include desk space, storage space, for CSPs to conduct their work as outlined in the PWS.

Utilities: The Government:

☒ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

3.2.2 Government will provide all utilities necessary for CSPs to conduct their work IAW PWS. The Contractor shall instruct employees in utilities conservation practices. The Contractor shall operate under conditions that preclude the waste of utilities, which include turning off the water faucets or valves, light switches, etc. after using the required amount to accomplish tasks requiring the use of the utilities.

3.3 Equipment: The Government:

☒WILL provide Equipment in support of this contract/task orders. The Government will provide equipment necessary for CSPs to perform their duties IAW PWS.

3.4 Procurement Integrated Enterprise (PIEE), GFP Module Application: Reserved.

3.5 Materials: The Government:

☒ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

3.5.1 The Government will provide all pertinent SOPs, policies, and procedures necessary for CSPs to perform work in the facility, ensuring compliance with facility directives.

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below:

4.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Part 5 of this PWS.

4.3 Equipment: The contractor shall provide their own vehicles and equipment to perform the work described in this PWS. Contractor's vehicles and equipment used in the performance of this contract shall meet all local and Host Nation traffic, safety, and environmental requirements.

4.4 Facilities: Reserved

PART 5

5.0 SPECIFIC TASKS

5.1. Contractor Furnished Property and Services

5.1.1. The contractor shall be responsible for completing the following:

5.1.1.1. General:

• Test specific specimen collection and preservation requirements for each test or an analyte.

• Test specific method and interpretation for each test or analyte.

• Test specific method reference ranges, adjusted for age, sex, or race, when applicable.

• Test specific method sensitivity, specificity, and interferences, when required.

• Test specific schedule of performance.

• Average turnaround time for each.

• Test Order Code

• CPT Code(s)

• Result Code

• Testing Location

5.1.1.1.1. Updated Information on Test Changes (i.e. changes in normal ranges, methods, and reporting units, etc.,). In the event of any methodology change, the contractor must have an effective notification system to provide the DHA COR, SA COs, and CO for each task order and each SA COR within 15 calendar days prior to the Contractor implementing said change. This will allow time for updating MHS Genesis test files and informing Medical Staff.

5.1.1.1.2. Contract Evolution and Technology Insertion: The services required under this contract are expected to evolve with advancements in medical technology and diagnostic practices. Accordingly, this contract contemplates the on-going insertion of new technology and the refreshment of existing equipment and services.

The Government, at its sole discretion, may incorporate such advancements at any time during the period of performance in accordance with the terms and conditions of this contract. The mechanisms for proposing, evaluating, and integrating these advancements are defined in the Special Contract Requirements Section of this resulting contract.

5.1.1.1.3. Product Information. The Contractor shall provide product information on new test(s) offered by the Contractor to the DHA COR.

5.2. Basic Services: The Contractor is providing necessary services required to perform clinical reference laboratory testing services including, supplies, labor, customer services, courier services, software, equipment, computers, IT, reporting/interpreting, result reporting, and management reports (refer to 5.3.16.3 – 5.3.16.9). The Contractor shall provide electronic interfaces between the Contractor's LIS and MHS Genesis for order entry and result retrieval. In emergency / contingency situations the Contractor shall use a secure web-based system. In case the web-based system is inoperable, courier services will be used for order entry and result retrieval. These services will be provided to Military Treatment Facilities (MTFs) via task order issued by each ordering activity.

The Contractor shall comply with all provisions of the Privacy Act of 1974 (Public Law 93-579) and HIPAA when providing Reference Laboratory Services.

5.2.1. The Contractor shall ensure accurate and timely performance of laboratory testing services in biologic specimens provided by Submitting Activities (SAs). The services provided must comply with and conform to all best practices as outlined by CLIA regulations, CAP standards, and all applicable state laws and regulations, and where applicable, New York State Department of Health licenses. Prime vendor (primary contract holder) must have and maintain accreditation with the College of American Pathologists (CAP). Subcontractors utilized by the prime vendor to perform clinical laboratory testing must have and maintain accreditation with a Health and Human Services (HHS) approved laboratory accreditation agency.

5.2.2. Laboratory directors shall be American Board of Pathology certified.

5.3. Tasks: Tasks consist of the following:

5.3.1. TASK - Materials: The contractor shall provide initial stock upon award. The Contractor shall provide an initial 8-week stock of materials, supplies and testing kits, to be used by the SAs identified in each task order, in preparation for the collection and shipment of specimens. The Contractor shall meet with SA COR during the transition phase to determine the quantity required for each site.

5.3.1.1. Sustainment/Ongoing stock:

5.3.1.1.1. The Contractor shall be responsible for providing test-specific collection kits and supplies needed for the shipment of specimens from SA to Contractor. Shipping and packaging containers and materials shall be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory under the terms of this contract.

5.3.1.1.2. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, are IAW appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

5.3.1.1.3. Test request forms, preprinted with the appropriate Shipping Section and account information for the tests offered. Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.). Forms and special handling procedures for medico-legal specimens when required by the Government.

5.3.1.1.4. Impervious bags for specimen pick-up. Bags shall have at least two sections, one for specimen(s) and one for paperwork.

5.3.1.1.5. Printer supplies including paper and labels, laser printer consumable supplies such as toner and cartridges in sufficient quantities to perform work under this contract.

5.3.1.1.6. Barcode labels for identification on each sample transfer tube, or specimen container if requested.

(Labels furnished by printing with the Contractor-provided LIS).

5.3.1.1.7. Written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and shipping or transport of containers.

5.3.1.1.8. The Contractor shall furnish materials, supplies, equipment, and reagents necessary to meet the requirements for the provision of services established under the terms of this contract.

5.3.1.1.9. The Contractor shall provide maintenance and replacement of furnished items to the Government for the entire contract period. The Contractor shall repair and/or replace equipment within 24 hours of notification by the Government of equipment failures.

5.3.1.1.10. The Contractor shall provide a 24-hour toll-free customer service/Help Desk telecommunication lines (including installation and maintenance service charges) to support incoming Government personnel calls for assistance.

5.3.1.1.11. Submitting Activities with on-site contracted Specimen Processor(s) will maintain stock of required supplies needed to collect and ship specimens. Maintenance of the stock is the responsibility of the Contractor.

5.3.1.1.12. Submitting Activities without an on-site contracted Specimen Processor(s) will be provided ordering instructions on how to request test-specific collection kits and supplies needed for the shipment of specimens from SA to Contractor.

5.3.1.1.13. The cost of the kits and shipping and collection supplies are the responsibility of the Contractor.

5.3.1.1.14. Supplies shall be replenished by the Contractor to allow for performance of all contract requirements without interruption.

5.3.1.1.15. On a case-by-case basis, emergency supplies will be requested by each SA POC and shall be provided by the Contractor. Emergency supply requests will be shipped via overnight delivery at the contractor's expense for receipt on the next business day.

5.3.2. Task - Testing. The Contractor shall provide the full range of clinical reference laboratory testing capabilities to execute required tests defined in the Contractor’s Price List/Required Schedule of Tests (Exhibit A). All tests shall be uniquely identified with a single test number that is standardized throughout the Contractor’s network of laboratories. All clinical reference laboratory testing, and anatomic pathology specimens, shall be executed IAW CLIA regulations, CAP, and all applicable state laws and regulations.

5.3.2.1. The Contractor shall not charge any set-up fees for cytogenetic tests showing no growth.

5.3.2.2. If a medico-legal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain valid “chain-of-custody possession” and develop the formal documentation necessary for that purpose. The Contractor’s testing personnel that performed the analysis can be required to provide Court testimony. Contractor testimony shall be provided as required to the Government. The costs associated with providing medico-legal testimony, including travel and labor hours, are not included in the fixed price of this contract.