Clinical Reference Laboratory Testing Services HT001526RE001

Title: DRAFT Request for Proposal (RFP) for Clinical Reference Laboratory Testing Services (CRLTS) - Request for Industry Comments and Questions NAICS Code: 621511 - Medical Laboratories Product Service Code (PSC): Q301 - Medical: Laboratory Testing Response Date: March 9, 2026 at 12:00 p.m. Central Time Point of Contact: Michael T. Bilicki, Contracting Officer, michael.t.bilicki.civ@health.mil Secondary POCs: Tamara Fenwick, tamara.k.fenwick.civ@health.mil; Melissa Hearst, melissa.l.hearst.ctr@health.mil Description: 1. PURPOSE This is a Special Notice issued by the Defense Health Agency (DHA) for market research purposes. The Government is posting a DRAFT Request for Proposal (RFP) to solicit feedback, comments, and questions from industry on the attached documents for the follow-on Clinical Reference Laboratory Testing Services (CRLTS) requirement. DISCLAIMER: This is NOT a formal solicitation or Request for Proposal (RFP), and no contract will be awarded from this notice. The Government will not pay for any information received in response to this notice, nor will it recognize any costs associated with the submission of a response. Participation is voluntary. The purpose of this draft RFP is to improve the clarity, quality, and feasibility of the final solicitation. 2. REQUIREMENT OVERVIEW The DHA requires a contractor to provide comprehensive, non-personal clinical reference laboratory testing services. The scope includes approximately 6,960 specialized medical tests that the Government cannot perform in-house. These services will support over 205 Military Treatment Facilities (MTFs) globally. A critical component of this requirement is the contractor's ability to establish and maintain a secure, bidirectional electronic interface between its commercial Laboratory Information System (LIS) and the Government's MHS Genesis electronic health record. The contractor must also meet stringent DoD cybersecurity requirements, including compliance with NIST SP 800-171 and CMMC 2.0. 3. PROPOSED ACQUISITION STRATEGY The following draft acquisition strategy is provided for industry feedback: Competition: Full and Open Competition Contract Vehicle: A single-award Indefinite Delivery/Indefinite Quantity (ID/IQ) contract Period of Performance: A five-year base ordering period and one five-year optional ordering period, for a total potential ordering period of ten (10) years. Source Selection Process: Performance Price Tradeoff (PPT), where non-price factors are significantly more important than price. 4. DRAFT DOCUMENTS FOR REVIEW Attached to this notice are the following DRAFT documents for industry review: Draft Request for Proposal (RFP) SF 1449 HT0015-26-R-E001 Exhibit A - Draft Price List_Schedule of Required Tests Exhibit B - Draft Clinical Reference Laboratory Testing Services QA Matrix Exhibit C -Draft Past Performance Summary Sheet Exhibit D - Draft Past Performance Questionnaire Exhibit E Draft Subcontractor Teaming Partner Letter and Table Attachment 1 Draft Performance Work Statement (PWS) Attachment 2 Draft Addendum to FAR 52.212-1 (Instructions to Offerors) Attachment 3 Draft Addendum to FAR 52.212-2 (Evaluation Criteria) PWS Attachment 1 Draft Summary of DoD sites PWS Attachment 2 Draft DD Form 1423-1 System Security Plan PWS Attachment 3 Draft B2B Gateway Implementation Plan and Questionnaire PWS Attachment 4 Draft DHA CAC Request Process PWS Attachment 5 Draft Request for Common Access Card PWS Attachment 6 Draft Example of DHA Common Training Requirements PWS Attachment 7 Draft DD Form 2875_System Authorization Access Request PWS Attachment 8 Draft Performance Requirements Summary PWS Attachment 9 Draft Deliverables 5. REQUEST FOR FEEDBACK The Government is seeking constructive feedback from industry to improve the final solicitation. Respondents are encouraged to provide comments and questions on all aspects of the draft documents, with a particular focus on: The clarity, feasibility, and completeness of the requirements in the Performance Work Statement (PWS). The clarity of the proposal submission instructions in the Addendum to FAR 52.212-1. The clarity and achievability of the evaluation criteria in the Addendum to FAR 52.212-2. Any requirements that may be ambiguous, overly restrictive, or inadvertently limit competition. Industry best practices that could improve the efficiency or effectiveness of the requirement. 6. INSTRUCTIONS FOR SUBMISSION All comments and questions must be submitted in writing via email to the primary and secondary POCs listed above no later than the Response Date in this Notice. To facilitate review, it is requested that respondents use the attached Exhibit B DRAFT Clinical Reference Laboratory Testing Services QA Matrix. The Government intends to review all comments and questions received. The Government may, at its discretion, publish a consolidated list of questions and answers at a later date. The Government's objective is to finalize a solicitation that is clear, equitable, and promotes robust competition. We thank you in advance for your time and valuable input. See attached documents.

Notice Type: Pre-solicitation Notice Title: Pre-solicitation Notice for Clinical Reference Laboratory Testing Services (CRLTS) Solicitation Number: TBD NAICS Code: 621511 - Medical Laboratories Product Service Code (PSC): Q301 - Medical: Laboratory Testing Point of Contact: Michael T. Bilicki, Contracting Officer, michael.t.bilicki.civ@health.mil Secondary POCs: Tamara Fenwick, tamara.k.fenwick.civ@health.mil; Melissa Hearst, melissa.l.hearst.ctr@health.mil Place of Performance: Global (CONUS and OCONUS) 1. SYNOPSIS AND INTRODUCTION The Defense Health Agency (DHA) is issuing this pre-solicitation notice to inform industry of an upcoming requirement to provide Clinical Reference Laboratory Testing Services (CRLTS). The purpose of this notice is to provide maximum advanced notification to industry to aid in proposal planning. This is a follow-on requirement to the services currently being performed under contract W81K04-21-D-0001, which is set to expire on June 30, 2026. 2. REQUIREMENT DESCRIPTION The Government requires a contractor to provide comprehensive, non-personal clinical reference laboratory testing services. The scope includes a menu of approximately 6,960 specialized medical tests that the Government cannot perform in-house due to a lack of capability, capacity, or specialized infrastructure. These services will support approximately 205 Military Treatment Facilities (MTFs) globally. A critical technical requirement of this effort is the contractor's ability to establish and maintain a secure, bidirectional electronic interface between its commercial Laboratory Information System (LIS) and the Government's MHS Genesis electronic health record. The contractor must also meet stringent DoD cybersecurity requirements, including compliance with NIST SP 800-171 and the CMMC 2.0 framework, as will be detailed in the solicitation. 3. PROPOSED ACQUISITION STRATEGY The Government s proposed acquisition strategy is as follows: Competition: Full and Open Competition. Contract Vehicle: A single-award Indefinite Delivery/Indefinite Quantity (ID/IQ) contract. Period of Performance: A five-year base ordering period and one five-year optional ordering period, for a total potential ordering period of ten (10) years. Contract Type: Firm-Fixed-Price (FFP) task orders. Source Selection Process: Performance Price Tradeoff (PPT), where non-price factors (e.g., Technical, Performance Risk, Small Business Subcontracting Participation), when combined, are significantly more important than price. 4. INCUMBENT INFORMATION The incumbent contractor for these services is LabCorp Inc., under contract W81K04-21-D-0001. 5. ANTICIPATED RELEASE This notice serves as a follow-on to the Draft Request for Proposal (RFP) that was previously posted for industry comment on 20 February 2026. The Government anticipates releasing the formal solicitation on or about 17 Mar 2026. Please note that while verbiage and/or format of the DRAFT RFP or its attachments/exhibits may change slightly due to industry comments, the Government is not anticipating widespread or major revisions at this time. All parties are advised to continue monitoring SAM.gov for the posting of the formal RFP and any subsequent announcements/notices associated with this requirement. 6. DISCLAIMER This pre-solicitation notice is for informational and planning purposes only and does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This notice does not commit the U.S. Government to contract for any supply or service whatsoever. The Government is not seeking proposals at this time and will not accept unsolicited proposals. Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this notice. All costs associated with responding to this notice will be solely at the interested party s expense. Not responding to this notice does not preclude participation in any future RFP, if any is issued.