Clinical Reference Laboratory Testing Services

Amendment / Modification

This document is an addendum to FAR 52.212-1, Instructions to Offerors for Commercial Products and Commercial Services. It modifies the original solicitation for a single Indefinite Delivery/Indefinite Quantity (IDIQ) contract for Reference Laboratory Services.

Key changes and additions include:

• Period for Acceptance of Offers: Offerors must hold prices firm for 180 calendar days from the proposal receipt date.
• Debriefings: Unsuccessful offerors requesting information will receive a debriefing in accordance with FAR 15.206 and FAR 15.301.
• Proposal Instructions (New Paragraph FAR 52.212-1(g)):
  • Proposals must consist of five (5) separate volumes: Business, Technical, Performance Risk, Small Business Subcontracting, and Price.
  • Specific submission instructions are provided, including email submission (max 20MB per email), subject line format, and the requirement for delivery and read receipts. USB drives, CDs, DVDs, and floppy/zip discs are not acceptable.
  • Formatting requirements include 11-point font, 8.5x11 inch pages with 1-inch margins, and specific page limitations for the Technical Proposal (45 pages).
  • Each volume must be standalone, and information must be in the correct section to be evaluated.
  • Questions regarding the solicitation are due by Monday, May 18, 2026, 12:00 p.m. Central Time.
• Basis for Award and Negotiations Process: The Government intends to award a contract to the best value offeror based on initial proposals but reserves the right to conduct negotiations. A competitive range will be established if negotiations are necessary.
• Evaluation Factors: Proposals will be evaluated on four factors in descending order of importance: Technical, Performance Risk, Small Business Subcontracting Participation, and Price. Non-price factors combined are significantly more important than Price.
• CMMC Compliance: Offerors must demonstrate cybersecurity compliance. Evidence of current CMMC Final Level 2 (Self) assessment in SPRS or a narrative for future compliance is required for proposal evaluation. Active CMMC Final Level 2 (Self) in SPRS is a mandatory condition for award.
• Price Proposal: Offerors must propose flat, firm-fixed prices for all ten years, building in foreseeable market and inflation risks. The Government will calculate a Total Evaluated Price (TEP) including a 5% escalation ceiling for evaluation purposes.

This addendum modifies FAR 52.212-1, specifically paragraphs (b), (e), and adds paragraph (g). It also details proposal structure, submission requirements, evaluation factors, and pricing rules.

Proposal submission instructions, formatting, volume structure, and evaluation criteria have been significantly updated. Offerors must carefully review these changes to ensure compliance. The deadline for questions has also been specified.

Form / Attachment / Pricing Sheet

This document, "PWS ATTACHMENT 1 - SUMMARY OF DoD FACILITIES," serves as an attachment to a Performance Work Statement (PWS). It provides a comprehensive list of Department of Defense (DoD) facilities, categorized by branch (Air Force, Army, Coast Guard, Navy), along with their respective DMIS Facility Names and DMIS IDs.

• Branch: Identifies the military branch associated with the facility (e.g., Air Force, Army, Coast Guard, Navy).
• DMIS Facility Name: The specific name of the facility or medical group.
• DMISID: A unique identification number for each facility.
• Note on List Changes: A concluding statement indicates that the list of sites is subject to change, with sites potentially being removed or added during the contract's life.

This attachment is crucial for bidders responding to a PWS. It details the specific locations where services may be required, helping vendors understand the geographical scope and potential operational footprint of the contract. Bidders should review this list to assess their capability to support operations at these diverse DoD facilities and to accurately estimate resource allocation and logistical needs.

Form / Attachment / Pricing Sheet

This document, "PWS Attachment 6 - Example of DHA Common Training Requirements.pdf", appears to be an attachment to a larger solicitation or contract. Based on its content, it serves as a list of mandatory training requirements for personnel within the Defense Health Agency (DHA) for Fiscal Year 2025. It outlines various federal training courses, their frequency, delivery methods, regulatory guidance, and which personnel categories (DHA Civilian, DHA Contract Support, Air Force, Army, Navy, etc.) are required to complete them.

• Training Topics: Covers a wide range of subjects including Cyber Awareness, HIPAA, Security Awareness, Records Management, Combating Trafficking in Persons, Suicide Risk Care, and more.
• Audience: Specifies which personnel groups are required to complete each training (e.g., Supervisors, Managers, Healthcare Providers, Senior Leaders, all DHA personnel).
• Frequency and Time: Details how often training must be completed (e.g., annually, one-time, every 3 years) and the estimated time commitment for each course.
• Regulatory Guidance: Lists the governing regulations or policies for each training requirement.
• Alternative Training: Indicates whether alternative training options are acceptable for certain courses.
• Frequently Asked Questions (FAQs): Addresses common questions regarding enrollment, audience definitions, healthcare provider definitions, and tracking training completion.

Bidders responding to an opportunity that includes this attachment should understand that personnel supporting the contract may be required to complete these mandatory trainings. This could impact resource allocation, onboarding timelines, and overall contract performance. Bidders should review the list to identify any training requirements that may affect their proposed staffing plan or operational approach. The document also clarifies how training completion is tracked and managed within the DHA, which may be relevant for reporting or compliance aspects of the contract.

Solicitation / RFP / RFQ

This solicitation (HT001526RE001) is for Clinical Reference Laboratory Testing Services to support Medical Treatment Facilities (MTFs) worldwide and other federal agencies. The services include testing for which the Government does not possess current capacity or capability, ranging in complexity from minimal to high complexity, in accordance with 42 CFR Part 493.

• Provision of Clinical Reference Laboratory Testing Services.

• Services include testing for which the Government does not possess current capacity or capability.

• Testing ranges in complexity from minimal to high complexity.

• The contract is for non-personal services.

• Contract Type: Single Award, Indefinite Delivery Indefinite Quantity (IDIQ).

• Period of Performance: Base period from July 1, 2026, to June 30, 2031, with option periods extending to June 30, 2036. An optional transition period of up to six months may be exercised.

• Estimated Value: USD 41,500,000.00 (Size Standard).

• Pricing Arrangement: Firm Fixed Price for most CLINs.

• Offer Due Date: June 1, 2026, 12:00 PM.

• Evaluation Factors: The Government will award to the responsible Offeror whose offer is most advantageous, considering price and other factors. Refer to Attachment 3 for detailed evaluation criteria.

• Submission Instructions: Offers must be submitted by the due date and time specified. Refer to FAR 52.212-1 for detailed submission requirements.

• This acquisition is unrestricted.

• NAICS Code: 621511

• Size Standard: Not specified, but the estimated value is USD 41,500,000.00.

• The solicitation incorporates FAR clauses 52.212-1, 52.212-4, and 52.212-5 by reference.

• DFARS clauses are also incorporated by reference and in full text.

• Specific requirements for Cybersecurity Maturity Model Certification (CMMC) are detailed, requiring Final Level 2 (Self) or higher.

• Economic Price Adjustments (EPA) and Technology and Pricing Refresh (TPR) provisions are included, with a global 5% life-of-contract escalation cap.

• A list of attachments is provided, including the Performance Work Statement (PWS) and various exhibits and addenda.

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide comprehensive clinical reference laboratory testing services to the Defense Health Agency (DHA) and other Government agencies, supporting both CONUS and OCONUS locations. The goal is to provide tests not currently supported by in-house DoD capabilities due to cost or inefficiency, often involving complex or specialized testing.

• Provide personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other non-personal services for clinical reference laboratory testing.

• Services encompass a broad range of disciplines including chemistry, hematology, coagulation, urinalysis, transfusion medicine, microbiology, molecular, histology, cytology, and genetic testing.

• Support receipt, transport, processing, testing, and reporting of results for projected annual requirements.

• Order and results transmission via the Contractor's Laboratory Information System (LIS) and MHS Genesis.

• Provide specimen processors to DoD sites sending over 2,000 specimens/month or expending over $30,000/month.

• Contractor must comply with CLIA regulations, CAP standards, and applicable state laws and regulations.

• Quality Control (QC) program must be implemented and maintained.

• External proficiency testing surveys required by CLIA must be performed.

• Turnaround Time (TAT) reports must demonstrate actual TAT meets established standards at least 98% of the time.

• Period of Performance: Five-year base ordering period and a potential five-year optional period (total of ten years).

• Transition Period: Up to six months for non-incumbent contractors.

• Place of Performance: Contractor's facilities or affiliated laboratories, and at specified Military Treatment Facilities (MTFs) for specimen processing.

• Non-personal services contract.

• Contractor must be compliant with CMMC Final Level 2 (Self) certification.

• Personnel must meet specific qualifications, including background checks and training.

• Adherence to cybersecurity requirements, including NIST SP 800-171 and CMMC.

• Provide a Mission Essential Contractor Services Plan.

• Government-furnished services include specimen collection, ordering tests, and providing workspace, utilities, and equipment at certain sites.

Amendment / Modification

This document is an addendum to FAR 52.212-2, "Evaluation-Commercial Products and Commercial Services." It provides details regarding the evaluation and award process for the Defense Health Agency's procurement of Reference Laboratory Services.

Key aspects covered include:

• The acquisition is for a single Indefinite Delivery/Indefinite Quantity (IDIQ) contract for Reference Laboratory Services.

• The period of performance includes a five-year base ordering period and a five-year option.

• The Government is utilizing the new Federal Acquisition Regulation (FAR) Overhaul.

• A single award will be made on a best-value tradeoff basis.

• Proposals must meet minimum requirements, including:

  • Compliance with FAR 52.212-1 and other specified volumes (Business, Technical, Performance Risk, Small Business Subcontracting, Price).
  • An "Acceptable" rating for the Technical Factor (Factor 1), including all technical sub-factors.
  • A "Satisfactory Confidence" rating or higher for the Performance Risk Factor (Factor 2).
  • An "Acceptable" rating for the Small Business Subcontracting Participation Factor (Factor 3).
  • A fair, reasonable, and balanced price.
  • Determination as a responsible contractor.

1. Technical (Factor 1): Assessed based on four equal sub-factors: Transition Approach and LIS Interface, Technical Requirements, Quality Control/Assurance Approach, and Supply Chain Management Plan.
2. Performance Risk (Past and Present Performance) (Factor 2): Evaluated based on recency, relevancy, and quality of performance.
3. Small Business Subcontracting Participation (Factor 3): Assessed quantitatively (meeting goals) and qualitatively (demonstrating commitment).
4. Price (Factor 4): Evaluated for fairness, reasonableness, and balance. Price is the least important factor.

• Volume I (Business Proposal): Pass/fail basis.
• Volume II (Technical Proposal): Rated "Acceptable" or "Unacceptable" based on integrated assessment of sub-factors.
• Volume III (Performance Risk): Assessed for confidence level.
• Volume IV (Small Business Subcontracting): Rated "Acceptable" or "Unacceptable."
• Volume V (Price Proposal): Evaluated for fairness, reasonableness, and balance.

Form / Attachment / Pricing Sheet

This document, "Exhibit A - Price List_ Schedule of Required Tests FINAL.xlsx", is a pricing sheet that outlines the costs associated with various laboratory tests. It provides instructions for offerors on how to complete and verify pricing information.

• Instructions for Price Summary Sheet: Offerors must verify all auto-calculations and report any formula errors to the Contracting Officer before submission.
• Instructions for Transition Sheet: Offerors must propose a Firm-Fixed-Price (FFP) for transition activities (PWS Section 1.6.1). This CLIN (0001) is priced for evaluation purposes by all offerors, but will only be exercised if awarded to a non-incumbent.
• Instructions for Exhibit A - Test Pricing Sheets: Offerors must verify extended prices (Unit Price x Government's Estimated Quantity). Miscellaneous Tests (Pass Through) are located in specific columns of the "Base Period Misc Test Pricing" and "Option Period Misc Test Pricing" tabs.
• Test Pricing Sheet Columns: Detailed instructions are provided for each column (A-K), including Test Name, Methodology, FDA/LDT classification, CPT Codes (where applicable), Turnaround Time, Prime Vendor/Subcontractor, Proposed Price, Estimated Yearly Quantity, Total Price, and Comments.
• Limitations on Adjustments: A 5% life-of-contract ceiling for cumulative pricing modifications under TPR and EPA is noted.

This document is critical for bidders to accurately price their proposed services. It details the specific tests to be priced, the required format for pricing, and the methodology for calculating total costs for both base and option periods. Failure to comply with these pricing instructions can result in an incomplete submission, rendering the offer ineligible for award.

Form / Attachment / Pricing Sheet

This document, titled "Exhibit B - Clinical Reference Laboratory Testing Services QA Matrix FINAL.xlsx", is a template provided by the Defense Health Agency (DHA) for industry feedback on the DRAFT Request for Proposal (RFP) for Clinical Reference Laboratory Testing Services (CRLTS).

• Submission Deadline: All questions and comments must be submitted no later than May 18, 2026, at 12:00 p.m. Central Time.
• Format: Feedback must be submitted using this Excel form. Narrative emails or other formats will not be accepted.
• Submission Method: The completed Excel file should be emailed to tamara.k.fenwick.civ@health.mil and melissa.l.hearst.ctr@health.mil.
• File Labeling: The Excel file must be clearly labeled with the submitting organization's name (e.g., "Q&A Matrix - XYZ Company").
• Column Instructions:
  • Column A: Enter the question number.
  • Column B: Reference the relevant PWS section, Exhibit, or Attachment.
  • Column C: Enter the question, comment, or feedback (may include "see attached").
  • Column D: Provide a recommendation and/or rationale.
  • Column E: Do not enter any information.

This form is critical for potential bidders to provide specific feedback on the DRAFT RFP. The DHA states that specific comments contained in this matrix may be considered in revisions to the final CRLTS RFP. Bidders must use this template to submit any questions or comments regarding the draft solicitation by the specified deadline.

Form / Attachment / Pricing Sheet

This document, Exhibit C - Past Performance Summary Sheet, is a form provided to offerors to detail their past performance references. It is to be completed in accordance with RFP HT0015-26-R-E001 Instructions to Offerors for Volume II.

• Company Information: Name, CAGE, UEI, and whether the entity is a Prime or Subcontractor.
• Contract Details: Contract Number, Period of Performance, and Contract Type (note: IDIQ basic contract numbers should not be provided; Task Order numbers should be used instead).
• Point of Contact (POC): Current email addresses and phone numbers for two Government POCs (one from the contracting office, one from the customer).
• Description of Relevancy: Details on the scope, location, complexity, and magnitude of the effort.
• Contract or Task Order Award Amount: Breakdown of the base year and each option year amount.
• Status of the Project: Reporting on performance status, years completed, and any terminations or scope change modifications.
• Awarded Price and Final/Projected Final Price: Price at award and the final or projected final price.

Bidders must use this form to document their past performance. Each past performance reference requires one summary sheet, and offerors are limited to two pages per project. This information is crucial for the government's evaluation of the offeror's ability to perform the required work.

Form / Attachment / Pricing Sheet

This document is Exhibit D, a Past Performance Questionnaire, required to be completed by a past performance reference. It is used to gather information about an offeror's performance on previous contracts.

• Respondent Information: Details of the Contracting Activity/Customer and their Point of Contact.
• Offeror's Reference Information: Details of the contractor being referenced, including their Point of Contact.
• Contract Information: Specifics of the contract being referenced, such as Contract Number, Task Order Number, Type of Contract, and Performance Period.
• Magnitude and Complexity: Information on the Description of Services, Annual Contract Value, Total Contract Dollar Value, Geographic description, approximate number of laboratory tests performed annually, and whether STAT Courier Services were provided.
• Contractor Role: Whether the contractor performed as Prime, Subcontractor, Teaming Partner, or Joint Venture.
• Performance Assessment: Definitions for performance ratings (Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory, Not Applicable).
• Assessment Areas: Sections to evaluate performance in Quality of Service, Cost Control, Timeliness/Schedule, Business Relationships, and Key Personnel, with specific questions and rating options.
• Performance Summary: Questions regarding awarding another contract to the firm and if the contract was terminated for default or cause.
• Evaluator Information: Fields for the Evaluator's Signature, Name, Title, Telephone, Email, and Date.

Bidders must ensure their past performance references are aware of this questionnaire and can provide timely and accurate responses. The information collected will be used by the government to assess the offeror's past performance, which is a critical factor in the evaluation of proposals for Solicitation Number HT0015-26-R-E001.

Form / Attachment / Pricing Sheet

This document, Exhibit E, provides a sample Subcontractor/Teaming Partner Consent Letter and a template for a Subcontractor/Teaming Partner (S/TP) Table. It is intended for use by potential subcontractors or teaming partners who wish to participate in the solicitation for Clinical Reference Laboratory Testing Services (RFP HT0015-26-R-E001).

• Consent Letter: Requires confirmation of the subcontractor/teaming partner's role, consent to the release of past and present performance information to the prime offeror for the government's risk assessment, and a signature from an authorized individual. It also requests company name, address, CAGE code, and contact information.
• Teaming Partner Table: This section requires detailed information about the prime offeror and any subcontractors or teaming partners. Information requested includes company name, small business designation, address, point of contact, and percentage of contract workload for each entity.

Potential subcontractors and teaming partners must complete and submit the Consent Letter and the Teaming Partner Table as part of their proposal or teaming arrangement. This document is crucial for outlining the structure of the proposed team and ensuring compliance with requirements related to performance information release and team composition.

Form / Attachment / Pricing Sheet

This document is a Contract Data Requirements List (CDRL) detailing the requirements for a System Security Plan (SSP) and associated Plans of Action for a Contractor's Internal Unclassified Information System. It specifies the format, content, and submission requirements for this deliverable.

• Data Item Number: P170
• Title: System Security Plan and Associated Plans of Action for a Contractor's Internal Unclassified Information System
• Subtitle: Initial
• Contract Reference: See PWS paragraph
• Requiring Office: THP/HPOSS
• Submission Frequency: One-time for the first submission (within 30 days of contract award), and annually thereafter for subsequent submissions (30 days before the anniversary date of each option period).
• File Format: No specific file format required.
• Content Details: The SSP must describe system boundaries, environments of operation, implementation of NIST SP 800-171 security requirements, and relationships with other systems. Plans of action should detail how deficiencies will be corrected. The use of the CUI SSP template available at https://doi.org/10.6028/NIST.SP.800-171r3 is recommended.
• Assessment Objectives: Contractors may use NIST SP 800-171A for their assessment rigor.
• Submission Method: Submit to the KO via the DOD Safe website.

This document outlines a critical security deliverable required from the contractor. Bidders must understand these requirements to accurately estimate the effort and resources needed for developing and submitting the System Security Plan and associated Plans of Action, ensuring compliance with NIST SP 800-171 security standards.

Form / Attachment / Pricing Sheet

This document, titled "PWS Attachment 3- B2B Gateway Implementation Plan and Questionnaire," outlines the requirements and procedures for vendors to establish a B2B Gateway connection with the Defense Health Agency (DHA) managed enclave. It serves as a guide for implementing a Server to Server (S2S) dedicated platform solution for external access and management.

• B2B Gateway Questionnaire: Vendors must complete this questionnaire to identify required system communication infrastructure and access requirements for connecting to DHA systems.
• Connectivity Requirements: Details include requirements for Wide Area Network (WAN), LAN, VPN, Web DMZ, and B2B Gateway access.
• Implementation Plan: Provides an overview of the DHA's B2B connectivity requirements, including appendices covering:
  • Software and Settings/Hardware Requirements (e.g., Cisco device models, licenses)
  • System Performance Requirements (e.g., response time, uptime, bandwidth)
  • VPN Implementation Form
  • Network Boundary Information (IP addresses, interfaces)
  • Diagrams (As Is, Last Mile)
  • Device Package Slip for shipping.
• POC Information: Lists key points of contact for both the Government (DHA) and the Vendor Partner.
• Approvals: Includes sections for Site ISSM, Program Manager, and Vendor Partner Security Manager approvals.

This document is critical for bidders to understand the technical and procedural requirements for establishing secure connectivity with DHA systems. It details the necessary hardware, software, network configurations, and documentation required for a successful B2B Gateway implementation. Bidders must carefully review the questionnaire and appendices to ensure their proposed solution meets DHA's standards and to prepare the necessary information for submission.

Form / Attachment / Pricing Sheet

This document, the "Defense Health Agency (DHA) Contractor Common Access Card (CAC) Request Process Handbook," Version 3.0 (July 2024), outlines the procedures for obtaining a Common Access Card (CAC) for contractors and other mission partners requiring access to Department of Defense (DoD) systems and facilities. It details the use of the Mission Partner Identity Credential and Access Management (MP-ICAM) application for sponsorship and management of these credentials.

• MP-ICAM Application: A Microsoft Excel spreadsheet with 28 data entry fields per applicant.
• Sponsorship: The process involves Facility Security Officers (FSOs) or Contracting Officer Representatives (CORs) submitting applications.
• Eligibility: The handbook specifies eligible applicants, including DoD Contractors, Foreign Affiliates, Presidential Appointees, Non-Federal Agency Civilians/Contractors, OCONUS Hires, and Other Government Agency Civilians/Contractors.
• Process Flow: Requires initiation or current investigation status via NBIS, verification by DHA NBIS POC, completion of the Excel spreadsheet by the FSO/COR, and submission to the DHA MP-ICAM Mailbox.
• Data Fields: Provides detailed guidance on completing specific columns within the Excel spreadsheet, covering applicant identification, personal details, contact information, sponsoring agency, contract details, and work location.
• Timelines: Applicants must report to a RAPIDS Issuing Facility within 89 days of approval, or the process must be reinitiated.

This handbook is critical for any contractor or potential bidder who will require a CAC for performance under a DHA contract. It clarifies the exact steps, required documentation, and data entry specifications necessary to obtain the CAC, ensuring a smoother onboarding and access process. Understanding these requirements is essential for accurate proposal preparation and timely contract execution.

Form / Attachment / Pricing Sheet

This document, DHA Form 33, is a "Request for DoD Common Access Card (CAC) Trusted Associate Sponsorship System Registration." It is used to initiate the process for obtaining a CAC, which is required for access to DoD facilities, networks, and systems.

• Section I: Requires information about the contract, including Contract Order Number and Contract Expiration Date.
• Section II: Requires identification and signature of the DHA Approving Official (COR, Task Manager, or Technical Representative).
• Section III: Requires detailed personal information for each applicant, including Last Name, First Name, MI, SSN, Date of Birth (DOB), Place of Birth (POB) or Country, and Email Address.
• Section IV: For Authorized Mission Assurance Personnel only, to verify background investigation status.
• Instructions: Provide guidance on completing the form, including verification of applicant eligibility, contract details, and submission procedures.
• Privacy Act Statement: Informs individuals about the authority, purpose, routine uses, and disclosure of the collected personal information.

Bidders responding to opportunities requiring CAC access will need to use this form to register their personnel. The form outlines the specific information required for each applicant and the verification steps that must be completed by the contracting organization and the Trusted Agent. It also details the contract information that must be provided, which is crucial for linking the CAC request to the specific contract.

Form / Attachment / Pricing Sheet

This document is the DD Form 2875, System Authorization Access Request (SAAR). It is used to request, modify, or deactivate access to Department of Defense (DoD) systems and information. Bidders may need to complete this form if they are contractors requiring access to specific systems as part of the contract.

• Part I: Requester's personal and contact information, system name, justification for access, and type of access requested.
• Part II: Endorsement and verification by the Information Owner/OPR, Supervisor, and IAO (Information Assurance Officer).
• Part III: Security Manager validation of background investigation or clearance information.
• Part IV: Account information prepared by authorized staff.
• Instructions: Detailed guidance on completing each section of the form.

If this opportunity requires contractor personnel to access government systems, bidders may be required to submit this form as part of their proposal or upon contract award. It outlines the necessary information and approval process for obtaining system access.

Statement of Work (SOW) / Performance Work Statement (PWS)

This document outlines the Performance Requirement Summary (PRS) for contractor service requirements, detailing performance objectives and minimum acceptable service levels critical for mission success.

• Issue Reporting: Contractor must inform the DHA COR in writing of issues impacting testing or test results within 12 clock hours of identification.

• Technical Data: Provide necessary technical data for new test interfaces within 2 business days of request.

• Methodology Changes: Notify DHA COR, SA COs, and SA CORs of updated test changes at least 15 days prior to implementation.

• Supplies & Equipment: Contractor-furnished supplies must be available for use 95% of the time.

• Courier Services: Ensure all courier pick-ups are not missed and are on-time. Unscheduled/STAT courier pick-up time must be within 3 hours after notification by the SA, 95% of the time.

• Lab Information System: Ensure SA has access to the LIS direct interface 98% of the time.

• Critical Results: Telephonic notification of critical results directly to the SA within 30 minutes after confirmation, 95% of the time.

• Amended Reports: Telephonic notification within 30 minutes and electronic transmission within 1 day, 95% of the time.

• Testing Errors: Report non-conforming events or erroneous test results to the DHA COR within 24 hours of discovery, 95% of the time. Provide full investigation and corrective action summaries within 30 days of discovery, 100% of the time.

• AP Specimens: Return AP specimens within 7 calendar days after final diagnosis, 98% of the time.

• Turn Around Times (TATs): Ensure established test TATs are met 98% of the time.

• Mission Essential Services Plan: Provide the plan to the COR/Designee within 30 days of contract award.

• Specific Acceptable Quality Levels (AQLs) are defined for each performance objective (e.g., 90%, 95%, 98%, 99%, 100%).

• Methods of Surveillance include DHA COR / Designee Periodic Inspection, review of reports, or by exception.

• Not explicitly detailed in this document, but references PWS sections and Exhibit A.

• Contractor-furnished supplies and equipment must be routinely replenished.

• A Mission Essential Contractor Services Plan is required within 30 days of contract award.

Statement of Work (SOW) / Performance Work Statement (PWS)

This document outlines the deliverables schedule for a Performance Work Statement (PWS) related to laboratory testing services.

The PWS details various deliverables required from the contractor, including:

• Providing processors to DoD sites for reference lab testing, ensuring timely specimen processing.
• Furnishing phase-in, phase-out services for a period of up to 180 days after contract expiration.
• Providing existing Quality Management Program (QMP) and Quality Control (QC) program documentation.
• Submitting a Proposed Quality Control Program (QCP).
• Delivering Quality Assurance (QA) policies.
• Providing QC results for assays, including ongoing calculations of QC performance (coefficient of variation, mean, and standard deviation).
• Submitting monthly Levy-Jennings graphs.
• Documenting appropriate analyzer maintenance.
• Providing verification results for non-regulated assays and for analytes without current proficiency testing.
• Listing external proficiency surveys the laboratory participates in, along with survey results and statistical reviews.
• Ensuring all test methods are US Food and Drug Administration (FDA) approved or have documented validation plans meeting CLIA, CAP, and CLSI guidelines for non-FDA approved methods.
• Providing CAP interim checklist reports and CAP inspection reports, including deficiencies and corrective actions, upon DHA COR request.
• Submitting contact information for the Contractor representative and alternate.
• Providing a Monthly SA Report.
• Reporting on Tests not Performed.
• Submitting Critical Results Reports and Quarterly TAT reports.
• Completing a Basic Assessment using the NIST SP 800-171 DoD Assessment Scoring Template and entering results electronically in SPRS.
• Developing and submitting a Mission Essential Contractor Services Plan.

Deliverables are to be submitted in specified formats (Searchable PDF or Spreadsheet) within defined timeframes (e.g., quarterly, within 7, 10, 14, 21, or 180 days of request or contract award) to the Contracting Officer's Representative (COR) or other designated personnel.

Not explicitly detailed in this attachment, but phase-in/phase-out services are specified for up to 180 days after contract expires.

• All test methods must be FDA approved or validated according to specific guidelines.
• Compliance with CLIA, CAP, and CLSI standards is required.
• Specific reporting and documentation requirements are outlined for various aspects of laboratory operations and quality control.