Reference Lab PWS 6 Feb 25 RFI.docx

PERFORMANCE WORK STATEMENT (PWS)

FY26 REFERENCE LABORATORY SERVICES

6 February 2025

Part 1 General Information

1. General: 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 Description of Services/Introduction: This is a non-personal service(s) contract to provide clinical reference laboratory testing services. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.2 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 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.

1.3 Scope: The Contractor shall provide non-personal service(s). The Contractor shall provide 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 U.S. Army, U.S. Navy, U.S. Air Force, U.S. Coast Guard, and the Defense Health Agency (DHA). Use of this contract will be limited to those agencies identified.

1.3.1 All tests shall be executed at the Contractor’s premises, or within the Contractor's network of laboratories [affiliate(s) or qualified subcontractor(s)].

1.3.2 The Defense Health Agency (DHA) Contracting Officer’s Representative (COR) is the focal point for this requirement. Each submitting activity will have their own Submitting Activity Contracting Officer’s Representative (SA COR).

1.3.3 Upon award of the contract, the Contractor will have a six-month transition period to comply with all requirements and achieve full testing performance.

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 I, across all the aforementioned disciplines. The contractor must possess sufficient infrastructure to fully support the timely receipt, transport, processing, testing, and reporting of results for the total projected annual requirements across all agencies. Order and results will be transmitted via the Contractor’s Laboratory Information System (LIS) and MHS Genesis.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): Quality Control: The Contractor shall implement and maintain, throughout the life of the contract, a Quality Management Plan (QMP) and Quality Control (QC) program to ensure services are performed in accordance with 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. The Contractor shall provide a copy of its existing QMP and QC program to the DHA COR within 15 days after contract award.

The Contractor’s Proposed QCP shall be submitted to DHA through the Contracting Officer’s Representative (COR) and to the Contracting Officer (KO) within 15 days after date of contract award (B.001).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 10 days. 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 may receive the Contracting Officer’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the Contracting Officer 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 must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team;

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of Defense (DoD) Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance;

(e) How the Contractor will ensure all keys issued will remain controlled items (Paragraph 1.7 Key Control);

(f) How the Contractor will inventory and track maintenance of all Government Provided Equipment / Materials;

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all Quality Control related documents for the life of the contract plus 5 years.

1.5.1.1 The Contractor shall provide, upon request, to the DHA COR, the following documentation:

· Quality assurance policies

· Quality control results for assays

· On-going calculations of quality control performance (coefficient of variation, mean and standard deviation)

· Monthly Levy-Jennings graphs

· Documentation of appropriate analyzer maintenance

· Verification results for assays of non-regulated analytes

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

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 12 clock hours of identifying those issues. Verbal reports shall be followed up by written reports within 7 days (B.002).

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

1.5.1.4 The Contractor shall perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor shall provide the DHA COR a listing of external proficiency surveys that the laboratory participates in accordance with (IAW) CLIA requirements (B.003). Survey results and statistical reviews for specific laboratory specialties shall be provided to DHA COR upon request.

1.5.1.5 All test methods shall be United States Food and Drug Administration (FDA) approved. Any non-FDA approved method being performed shall have a documented validation plan that as a minimum meets guidelines established by CLIA, CAP, Clinical Laboratory Standards Institute (CLSI), and any additional applicable portions of the Code of Federal Regulations (CFR) for the implementation of non-FDA approved (commonly referred to as Laboratory Developed Tests (LDT)) assays for use in human testing. Documentation will be provided to DHA COR upon request.

1.5.1.6 Upon DHA COR request, the Contractor shall provide CAP interim checklist reports and CAP inspection reports to include deficiencies and corrective actions within 10 calendar days of receiving the report. The Contractor shall submit to the DHA COR notification of completion of corrective action.

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do 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 acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

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

1.5.3.2 Host Nation Holidays: RESERVED

1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are 0800 to 1600 hours, Monday through Friday, except U.S. Holidays identified in paragraph 1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2 Government Facility Operating Hours: The Government facility hours of operation vary by location and facility type, e.g., clinic, hospital, medical center. Normal duty hours are typically 0730 to 1600 hours, with clinics operating Monday through Friday. Hospital and Medical Centers operate 24 hrs a day, 7 days a week and are open during the recognized U.S. Holidays identified in paragraph 1.5.3.1 above. The Government facility may close due to local or national emergencies, administrative closings, or similar Government directed facility closings and will be communicated by the Contracting Officer to the Contractor.

1.5.4.3 Contractor Support Hours: The Program manager should be available 0800 through 1700 hrs Monday through Friday. The contractor shall provide a contactor representative (CR) to resolve any, technical issues, and/or problem areas the customers may be experiencing in the field. They shall be able to contact the program manager at any time if something needs to be escalated to that level. The CR shall be available 24 hours 7 days a week via telephone, and be available in person by appointment, upon request by the KO or the SA COR. The CR shall be available to support each Submitting Activity (SA) within their assigned territory, for services that include but are not limited to, troubleshooting, servicing, and introducing new tests, within 72 hours. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.4.3.1 Contractor Work Plan: RESERVED

1.5.4.3.1.1 The Contractor shall provide all management services, planning, programming, administration, supervision, personnel, labor, materials, facilities, transportation, general and specialized equipment, supplies, and execution necessary to provide the specified services.

1.5.4.3.1.2 The Contractor shall ensure that decisions related to clinical operations, or any other overarching business related to this contract, are only discussed with the KO, DHA COR and the Center for Laboratory Medicine Services. Topics or items affecting this contract and/or Exhibit C (test menu/catalog) shall not be discussed at the site or local level.

1.5.4.3.1.3 The Contractor shall perform all work in accordance with this contract and all applicable Federal and state laws, regulations, and directives to include applicable publications and instructions listed in Exhibit X.

1.5.4.3.1.4 The Contractor shall accept orders for tests incorporated into the contract listed in Exhibit C (Contractor’s Pricelist). Orders not on the Contractors Pricelist, may be processed but require approval of the COR. The Contractor shall not increase prices on the Contractor’s Pricelist without prior written approval of the KO. Changes to the Pricelist to include an increase or decrease of prices, and/or addition of new tests, shall only be made via a bi-lateral modification between the Contractor and the KO.

1.5.4.3.1.5 The Contractor shall compile historical data, prepare required reports, and submit information as specified in this contract.

1.5.4.3.1.6 The Contractor shall ensure work meets quality and timeliness requirements specified in this contract, to include scheduling change(s) of processors, technicians, courier services and responding to critical requirements such as emergency contingencies.

1.5.4.3.1.7 The Contractor shall ensure all laboratory facilities used to perform the requirements of this contract meet and maintain all state, federal and occupational standards, certification(s), accreditation(s), license(s), etc., required when executing performance under this contract.

1.5.4.3.1.8 The Contractor shall ensure all Contract Service Providers (CSPs) are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate.

1.5.4.3.1.9 The Contractor shall ensure every contract laboratory, owned, affiliated or subcontracted, complies with the Clinical Laboratory Improvement Amendment of 1988 (CLIA), is accredited by the CAP, and complies with all applicable State laws and regulations.

1.5.4.3.1.10 The Contractor shall ensure all testing and supervisory personnel at every contract laboratory, owned, affiliated, or subcontracted assigned to work under this contract complies with the CLIA, the College of American Pathologists (CAP), and with applicable State laws and regulations.

1.5.4.3.1.11 The Contractor shall ensure every contract laboratory, owned, affiliated, or subcontracted performing drug abuse blood or urine testing under this contract shall be currently certified by the National Institutes of Drug Abuse (NIDA) or American Board of Forensic Toxicologists (ABFT). If the prime Contractor does not have NIDA or ABFT certification and proposes a subcontractor with NIDA or ABFT certification, the subcontractor shall meet all of the other required certifications and qualifications herein.

1.5.4.3.1.12 The Contractor shall submit a copy of the professional certification and/or licensure of the corporate Laboratory Director, and/or Medical Director, and Technical Supervisors of the Contractor’s primary laboratories to the DHA COR within 21 days after contract award (B.004).

1.5.4.3.1.13 The Contractor shall provide a copy of the certificate of accreditation within 21 days after award, to the DHA COR, for all Contractor-owned, affiliated, or subcontracted laboratories (B.005).

1.5.4.3.1.14 The Contractor shall notify the KO within 24 hours, in writing, upon its loss of any required certification, accreditation, or licensure (B.006).

1.5.4.3.1.15 The Contractor shall keep the DHA COR, all KOs and the SA COR as identified on each task order, informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests through periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations on a quarterly basis.

1.5.5 Training Holidays: Contractor personnel assigned to support MTFs are expected to work on training holidays and minimal manning days, if the facilities are operational.

1.5.6 Place of Performance: The work to be performed under this contract will be performed at the contractors facilities.

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: (If applicable) Contractor personnel performing work under this contract must have a (Insert the level of security required, if and as applicable) at time of the proposal submission, and must maintain the level of security required for the life of the contract. The security requirements are IAW with the DoD Contract Security Classification Specification (DD Form 254), which is currently accessible at the following link: http://www.dtic.mil/whs/directives/forms/eforms/dd0254.pdf (The RA's unit security monitor is responsible for initiating this form.)

1.6.2 Personnel Security Clearance Requirements: (If applicable) Contractor personnel performing work under this contract must have an active personnel security clearance at the (Insert the level of security clearance required, the highest level required, if applicable) level in the Defense Information System for Security (DISS) at time of the proposal submission, and must maintain the level of security required for the life of the contract. The security requirements are IAW the DoD Contract Security Classification Specification DD Form 254. (The RA's unit security monitor is responsible for initiating this form.) The Contractor shall ensure that Contractor employees and subcontractor employees performing services under this contract comply with FAR 52.204-2 Security Requirements when the employee has access to information classified “Confidential,” “Secret,” or “Top Secret.” The Contractor shall ensure the employee complies with the DoD Security Agreement (DD Form 441), and the NISPOM rule at 32 Code of Federal Regulation (CFR) Part 117, effective 24 Feb 2021. The NISPOM is the National Industrial Security Program Operating Manual to which contractors must implement and comply.

1.6.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized (if applicable include OCONUS wording “by Host Nation law to work in that country”). Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

1.6.3.1 Installation Pass Log: RESERVED

1.6.3.2 Individual Termination or Expiration of Employment: The Contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within ?? days (B.007).

1.6.3.3 Contract Termination or Cancellation: Upon termination or cancellation of this contract, the Contractor shall collect all outstanding installation access passes and return them to the issuing office within 7 days (B.007).

1.6.3.4 Common Access Cards (CAC) and CAC Log: The Contractor shall provide the following information: Last, First and Middle Names, government issued personal identifier (e.g. Social Security Number, Federal Identification Number, or Tax Identification Number), date of birth, primary email address (this email address will be used to contact the individual) and any other necessary information required to obtain a CAC or installation access card, to the COR with 14 days after award (B.008). The Contractor shall ensure safeguarding of Personally Identifiable Information (PII) and comply with requirements under 1.22.5.

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

The Contractor shall provide a CAC log within the 30 days of contract award and within 5 days after changes have been made (B.009) after contract award and within five (5) days after changes have been made (unless circumstances require otherwise and as directed by the Contracting Officer). The COR will provide format and content for the log during the post award meeting. Note - CACs are Government property and must be accounted for.

Security Clearances. Personnel to be assigned to an Automated Data Processing (ADP)/IT position must undergo a successful security screening before being provided access to DoD IT resources. Prior to an employee being granted interim access to DoD sensitive information, the COR must receive notification that the Office of Personnel Management (OPM) has scheduled the employee's investigation. This requirement shall be met by Contractors, subcontractors and other who have access to IS containing information protected by the Privacy Act of 1974 and protected health information under Health Insurance Portability and Accountability Act of 1996 (HIPAA). Background checks are required, and will be completed by the contractor, for all ADP/IT personnel who receive, store, display, or transit sensitive information. Employees shall have at a minimum an ADP Sensitivity Designation of Level II to access the DoD Network.

All Contractors that use the DoD gateways to access Government systems shall submit a System Authorization Access Request Form (DD 2875) or equivalent in accordance with COR guidance. The Contractor shall complete the applicable training, Form DD 2875 and submit to the DHA COR for processing.

All costs for the Contractors employee background investigations are the responsibility of the Contractor.

The terms and conditions of this clause must be completed no later than 30 days after contract award.

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

1.6.4 Background Checks: (Applicable to CONUS and OCONUS requirements, the RA shall consult with the responsible Security Office and Activity Manager applicable to location(s) associated with this PWS and identify the level of background check, supported by the applicable regulation(s).)

1.6.4.1 U.S. Citizen: Contractors that work with or teach youth under the age of 18 years are subject to U.S (and host nation if OCONUS) background checks. The Requiring Activity Manager will determine the extent of background checks required. The Contractor employee may begin performance of the contract after receiving a favorable local background check. The Contractor agrees to replace the employee should results of the background check, if required, be unfavorable as determined by the Requiring Activity Manager. The Contractor’s replacement of the employee with the unfavorable background check shall be within a timeframe provided by the Requiring Activity Manager. The Contractor shall also replace employees whose background check, during their tenure of employment, renders them with an unfavorable local or stateside background check, as determined by the Requiring Activity Manager. The Contractor shall forward a copy to the Contracting Officer via the COR and the Requiring Activity Manager of each favorable background check within (Insert number of days) of receipt by the Contractor, identifying such with the appropriate contract number ({Insert Deliverable #}). The Contractor shall forward a copy to the Contracting Officer via the COR and the Requiring Activity Manager of each unfavorable background check within (Insert number of hours or days) of receipt by the Contractor, identifying such with the appropriate contract number ({Insert Deliverable #}). When the Government awards a non-personal services contract directly to an individual, the failure of the individual to provide a favorable background check would be grounds for termination.

1.6.4.2 Local Nationals and Third Country Nationals: (For locations and work performed OCONUS, RA shall consult with the responsible Security Office and Activity Manager applicable to location(s) associated with this PWS.)Local national and third country national Contractors that work with or teach youths under the age of 18 years are subject to background checks as determined by the Requiring Activity Manager. As a minimum prior to beginning performance, Contractors employing local national and third country nationals shall furnish the Contracting Officer via the COR and the Requiring Activity Manager current documents required for working on a US installation, no later than (Insert number of days – for example, “no later than five (5) days after contract award … or … during the post-award meeting, etc”.) ({Insert Deliverable #}). Forwarding correspondence from the Contractors shall identify the associated contract number. (Sample OCONUS wording for work performed in Germany, edit as appropriate for applicable country/countries – “The Requiring Activity Manager will determine the favorability of the Polizeiliche Fuehrungszeugnis and notify the Contractor. The Contractor shall forward a copy of unfavorable Polizeiliche Fuehrungszeugnis to the Contracting Officer via the COR and the Requiring Activity Manager within (Insert number of hours or days) of receipt, identifying such with the appropriate contract number. Local nationals and third country nationals agree to the same employee termination provisions as stated for U.S. Citizens (see paragraph 1.6.4.1 above, in particular, same requirements to replace the employee (and within timeframe noted) when results of background check are unfavorable”).

1.6.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use. Access and General Protection/Security Policy and Procedures. Contractor and all associated subcontractor employees shall comply with applicable installation, facility, and area commander installation/facility access and local security policies and procedures (provided by Government representative). The Contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshall Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements as direct by DOD, HQDA, and or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes. No CSP shall be permitted on the installation when his/her presence would be detrimental to the security of the installation.

1.6.5.1 The Government reserves the right to require removal from the job site any CSP who endangers persons or property and whose continued employment is inconsistent with the interest of government security. In such cases, the KO will advise the Contractor of the reason for requesting a CSP’s removal or withdrawing his permit to enter the installation.

1.6.5.2 The Contractor shall remove from duty any CSP found to be incapacitated or under the influence of alcohol or drugs, or other incapacitating agents and shall not return such CSP to duty until such CSP is fully able to perform the normally assigned duties. Removal of CSP(s) for such causes does not relieve the Contractor of the requirement to provide sufficient personnel to adequately perform services specified under this contract.

1.6.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel. Government issued access badges shall not be worn outside designated facilities where visible to the general public.

1.6.6.1 Operational Security (OPSEC). Contractor shall practice OPSEC to protect critical information for specific government contracts and subcontracts. Neither the contractor, nor any of its CSPs, nor the family members of its employees shall disclose or cause to disseminate any information concerning operations of military activities. Such action(s) could result in violation of the contract and possible legal actions.

1.6.6.2 OPSEC Training. New contractor employees must complete the government’s Level I OPSEC training within 30 calendar days of reporting for duty. Contractor employees who will be physically located at a medical treatment facility must complete annual OPSEC awareness training and will provide certificates of completion to the SA COR (or contracting officer if a COR is not assigned). Contractor employees only access the electronic health records remotely will submit certificates of completion to the DHA COR. Certificates of completion will be submitted within 5 calendar days after completion of training (B.012)

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

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

1.6.6.5 Follow the DoD guidelines for submittal of ADP/IT background investigations and ensure all Contractor personnel are designated as ADP/IT-I, ADP/IT-II, or ADP/ITIII where their duties meet the criteria of the position sensitivity designations outlined in Department of Defense Directive (DoDD) 8140.01 and DoD 8570.01-M.

1.6.6.6 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to IS within the logical boundaries of the facility local area network (LAN).

1.6.6.7 Immediately report to the MTF’s security office and deny access to any Automated Information System (AIS), network, or information if a Contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate Government representative for any reason.

1.6.6.8 Ensure that all Contractor personnel receive IA training before being granted access to DoD AISs/networks and information.

1.6.6.11 The Contractor shall correct any deficiencies identified by the Government of the Contractor's physical security posture.

1.6.6.13 Cybersecurity. Applicable for those DHA acquisitions where a non-DoD information system (IS) or covered contractor IS are not part of a DoD IT Service or system operated on behalf of the Government . The covered contractor IS shall be subject to the security requirements in DoDI 8582.01, “Security of Unclassified DoD Information on non-DoD Information Systems”. The contractor shall be required to implement the security requirements prescribed in the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations” (available via the internet at https://doi.org/10.6028/NIST.SP.800-171r3)..

1.6.6.14 The Contractor shall have a current (i.e., not more than 3 years old) basic self-assessment summary-level score posted in the Supplier Performance Risk System (SPRS) at time of award and include results in its proposal.

1.6.6.15 The Contractor shall complete a Certification of Compliance Checklist (Exhibit D) and submit in accordance with delivery schedule (Exhibt B).

1.6.6.16 The Contractor shall have a current (i.e., not more than 3 years old) Cybersecurity Maturity Model Certification (CMMC) Level 2, issued by an authorized CMMC third-party assessor organization (C3PAO), posted in the SPRS and results in its proposal.

The contractor shall track and assess compliance of its subcontractrors with the NIST SP 800-171 requirements in accordance with DFARS clause 252.204-7020 flow-down requirements.1.6.6.18 DHA Business-to-Business (B2B). If there is a B2B connection requirement, the contractor shall procure a hardware-specific VPN/ISR to connect to the B2B gateway along with the Assess only review. The Contractor shall coordinate with the Government to support the B2B Gateway connectivity process.

1.7 Key Control: RESERVED

1.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall 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.

1.8.1 The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.8.2 The Contractor shall attend a monthly teleconference to discuss and provide a progress report on/around 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 8.16 “Task – Transition Period” for specific requirements.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter 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 order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. 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 Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: The following personnel are considered key personnel by the Government: Program/Contract Manager/Alternate Program/Contract Manager, Quality Control Manager. The Contractor shall provide a Program/Contract Manager who shall be responsible for the performance of the work. The name of this person and an Alternate Program/Contract Manager, who shall act for the Contractor when the Program/Contract Manager is absent, along with a Curriculum Vitae (CV) for each of these individuals, shall be provided in writing to the Contracting Officer during the postaward meeting, etc. Acceptance of the CV by the Contracting Officer is required before these individuals are permitted to perform any task on this contract. The Contract Manager and Alternate Contract Manager 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 Contract Manager shall be available between 0800 through 1700 hrs, Monday through Friday. Additionally, the CR should retain ability to contact contract manager as necessary. Qualifications for all key personnel are listed below:

a. Contract Manager and Alternate Contract Manager: The CV provided by the Contract Manager and Alternate Contract Manager must demonstrate a minimum of 5 years’ experience within the past 15, working as a Program Manager

b. Quality Manager or Quality Control Manager and Alternate must demonstrate a minimum of 2 years’ experience within the past 10, working in Quality Management.

c. The Contractor shall ensure that all Contractor personnel providing 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 12 funded health care programs. The list may be found at http://oig.hhs.gov/fraud/exclusions.asp.

• Contractor personnel shall be a U.S. citizen or otherwise meet the requirements of AR 25-2, Information Assurance.

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

• Contractor personnel shall successfully complete a criminal history background check in accordance with paragraph 1.6.4. of the PWS.

• 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.

• Contractor personnel shall possess sufficient initiative, interpersonal relationship skills and social sensitivity such that the Contractor personnel can relate to a variety of patients from diverse backgrounds.

• CSPs are required to meet Continuing Medical Education (CME) requirements as determined by their accrediting organization . The Government will not reimburse for these costs.

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

• Contractor and CSPs shall abide by all standards, rules, and procedures including requirements for licensure, credentialing, and quality assurance programs.

• 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.

• The CSP is not listed on the Health and Human Services (HHS) list of providers excluded from Federally funded health care programs. The list may be found at http://oig.hhs.gov/fraud/exclusions.asp.

• CSPs demonstrate ability to use microcomputers; ability of data processing operations and relational database software, spreadsheet software, word processing (e.g., Windows 07, Word).

d. Special Qualifications:

1.10.1 Project Manager. The contractor shall designate a full-time Project Manager and alternate(s). The PM (or alternate) shall be responsible for overall contract performance and shall have full authority to act for the contractors on all matters related to contract operations under their purview.

1.10.1.1 Contractor Representative (CR). The Contractor shall provide a CR to resolve any administrative, technical issues, and/or problem areas the customers may be experiencing in the field. The CR shall be available 24 hours 7 days a week via telephone, and be available in person by appointment, upon request by the KO or the SA COR. The CR shall be available to support each Submitting Activity (SA) within their assigned territory, for services that include but are not limited to, troubleshooting, servicing, and introducing new tests, within 72 hours.

1.10.1.2 Specimen Processing / Data Entry Technician(s). The Contractor shall provide a technician(s) to process (spin, aliquot), label, and package specimens in the proper shipping envelope and/or container for pickup and delivery to the Contractor’s laboratory testing site(s) using proper protective equipment and universal precautions. The technician(s) will ensure the specimens are checked and logged before leaving the SA laboratory shipping room as part of their certification of receipt procedures.

1.10.1.3 The technician(s) shall be responsible for transmitting laboratory test requests, retrieving laboratory results, obtaining test information, printing patient reports, and printing utilization reports from the Contractor’s LIS.

1.10.1.4 Technician(s) shall also maintain and order all necessary supplies to support this effort.

1.10.1.5 Technician(s) will assist with processing specimens and accurately entering laboratory results into Military Health System (MHS) Genesis when the interface between the Contractor’s Laboratory Information System (LIS) and MHS Genesis is not available.

1.10.1.6 Technician(s) must complete Department of Defense (DoD) Information Assurance, Operations Security (OPSEC) General User Training and successfully complete a security investigation, e.g., National Agency Check with Law Enforcement and Credit (NACLC), or equivalent within 30 calendar days after task order award. The technician(s) will need to complete the above tasks in order to obtain a common access card (CAC Card). Security investigation is the responsibility of the contractor.

1.10.1.7 Technicians must comply with required Common (Individual) mandatory training topics in accordance with DHA Procedural Instructions (See Exhibit ??) and the medical treatment facilities’ policy. This includes but is not limited to OPSEC, SHARP, Anti-Terrorism Level I, Threat Awareness & Response Program (TARP), Information Security, Information Assurance, Cybersecurity, and Combatting and Trafficking in Persons.

1.10.1.8 Customer Services. The Contractor shall provide customer service personnel who shall be accessible by a tollfree telephone service 24 hours per day, 7 days per week to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, requesting emergency courier service, using the provided computer system, and other applicable related issues/problems that may arise in the performance of work under this contract.

1.10.1.9 Courier Services. The Contractor shall provide courier service personnel (transportation) to pick up, ship, and deliver specimens from the SA site to the Contractor laboratory.

1.10.1.10 Couriers will need to be able to access to military installations. Access instructions are dependent upon each installation. All costs associated with obtaining access to military installations are the responsibility of the contractor.

1.10.1.11 The Contractor shall provide routine local courier pick-up services at each SA on a daily basis (Monday – Friday, excluding federal holidays) at a time mutually agreed upon by the SA COR and the Contractor.

1.10.1.12 Computer / IT Support Personnel. The Contractor shall provide computer support personnel to address MHS Genesis Test File support. Computer support personnel will assist sites with the modification and /or build of Lab Test files (LTF) to support the vendor’s electronic interfacing capabilities to MHS Genesis.

1.10.1.13 Computer Support Personnel must complete Department of Defense OPSEC, Antiterrorism Level I, and Cyber Awareness training, at a minimum, and must successfully complete a security investigation, e.g., National Agency Check with Law Enforcement and Credit (NACLC) or equivalent. The security investigation is the responsibility of the contractor. The Computer Support personnel will need to complete the above tasks to obtain a common access card (CAC Card).

1.10.1.14 Computer support personnel must meet Automated Data Processing (ADP)/ IT-II for access to MHS systems including MHS Genesis.

1.10.1.15 When a test is requested that is not already interfaced, Computer Support Personnel will build the LTF or work with MHS Genesis Test File support team to ensure test is interfaced within 5 working days.

1.11 Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12.1 Contractor workspace (staging site, on-site office, desk or work area, etc.) shall contain a sign signifying the space is occupied by Contractor employee(s) to ensure that Government employees and the public know that they are not Government employees. The proposed sign shall be submitted to the Contracting Officer via the COR for review and acceptance after contract award (B.013). Workspace sign location shall be coordinated with the COR. Contractor employees shall identify themselves by name and company affiliation when answering the telephone, presenting briefings, conducting or attending meetings, and seminars. All Contractor correspondence (written, facsimile, and email display) shall include their company name. Requirements for Contractor vehicles is addressed under Part 4 paragraph 4.4.

1.12.2 Contractor Identification Badges: Contractor…