FY26 Lab Consolidation for Coagulation CPRR Effort

Amendment / Modification

This amendment (0001) revises the Combined Synopsis Solicitation (CSS) HT941026Q2004.

Specifically, it:

• Posts "CSS Coagulation Attachment 3 Quote Sheet Amendment 0002" for feedback.

• Sets the feedback due date to Wednesday, June 3, 2026, at 1300 PST.

• The "CSS Coagulation Attachment 3 Quote Sheet" has been amended.

• Vendors must submit any amended quotations using the revised "CSS Coagulation Attachment 3 Quote Sheet".

• All other provisions and conditions of the original CSS remain unchanged.

Form / Attachment / Pricing Sheet

This document, "CSS Coagulation - Attachment 3 Quote Sheet Amendment 0002.xlsx", serves as a quote sheet and acknowledgment of amendments for the "DHA HCD-W Coagulation CPRR" requirement. It is intended for bidders to provide their pricing and confirm receipt of solicitation amendments.

• RFQ Number: HT941026Q2004
• Requirement: DHA HCD-W Coagulation CPRR
• Contracting Office: DHA Healthcare Contracting Division - West
• Offeror Information: Fields for Quoter Name, Address, UEI, CAGE Code, POC, Phone, and Email.
• Amendment Acknowledgment: Section to list received amendments.
• Pricing Tables: Detailed breakdown of estimated annual test counts and costs per reportable result for various coagulation tests (e.g., PT, APTT, Fibrinogen, D-Dimer) across different networks and locations. This includes Base Period, and four Option Periods (1-4), plus an "Option IAW RFO 52.217-6".
• Price Firmness: Offerors must agree to hold prices firm for 60 calendar days.
• Signature Block: For authorized personnel to sign.

This attachment is critical for bidders to understand the estimated volume of tests required by location and period, and to submit their pricing accordingly. It also requires bidders to acknowledge all amendments issued to the solicitation. The pricing provided in this sheet will be a key component of the proposal evaluation.

Solicitation / RFP / RFQ

This document is a combined synopsis/solicitation (RFQ) for a cost per reportable result (CPRR) contract for coagulation analyzers. The contract will support multiple military treatment facilities (MTFs) across various networks (Pacific Rim, Indo Pacific, Continental, Central, West). This is an unrestricted procurement, not set-aside for small businesses.

• Procurement of coagulation analyzers to support military treatment facilities.

• The contract will be for a cost per reportable result (CPRR) basis.

• Specific test types required include PT, aPTT, D-Dimer, Fibrinogen, Heparin, Factor VIII, Lupus Anticoagulant, DIC Panel, Antithrombin III, Von Willebrand Factor Antigen, Factor II Assay, and INR.

• The document lists the estimated annual workload (total tests/year) for each MTF.

• Contract type: Firm-Fixed-Price (FFP).

• Period of performance: Not explicitly stated, but the offer period is 60 calendar days.

• Estimated value: Not stated.

• Quotes must be submitted electronically by 1:00 p.m. Pacific on Tuesday, June 9, 2026.

• Evaluation factors include: Technical, Past Performance, Information Assurance, and Price.

• Technical and Past Performance are considered approximately equal in importance and combined, more important than Information Assurance. Non-price factors combined are more important than Price.

• Award will be made on a "Best Value Tradeoff" basis.

• Key submission requirements include:

  • Attachment 2: Technical Submission Form
  • Completed CyberLOG-ICS Medical Device and Equipment Risk Assessment (MDERA) Questionnaire (SOW Enclosure B)
  • Attachment 3: Quote Sheet (signed, with pricing list)

• Questions regarding the RFQ must be submitted by email no later than 1300 p.m. Pacific on Thursday, May 28, 2026.

• This acquisition is not set-aside for small business concerns. It is an unrestricted procurement.

• Quoters must be an original equipment manufacturer (OEM), authorized dealer, distributor, reseller, or authorized service provider, verified by the OEM.

• The solicitation incorporates provisions and clauses by reference, accessible electronically at www.acquisition.gov.

• Defense Biometric Identification System (DBIDS) is required for access control.

• Specific cybersecurity and Information Assurance requirements are detailed, including RMF authorization processes and adherence to DHA Cybersecurity Requirements.

Amendment / Modification

This amendment (0001) revises the Combined Synopsis Solicitation (HT941026Q2004) for the FY26 HCD-W Coagulation Analyzer Cost Per Reportable Results.

Specifically, the following due dates have been revised:

• Questions due date

• Quotations due date

• The amendment directly impacts the due dates for questions and quotations.

• Bidders must acknowledge this amendment.

• Any amended quotation must be submitted utilizing the CSS Coagulation Attachment 3 Quote Sheet.

• All other paragraphs, provisions, and conditions of the original Combined Synopsis and Solicitation remain unchanged.

Solicitation / RFP / RFQ

This document is a combined synopsis and solicitation (RFQ) for a Cost Per Reportable Result (CPRR) contract for coagulation analyzers. The contract will support multiple military treatment facilities (MTFs) across various networks (Pacific Rim, Indo Pacific, Continental, Central, West). The acquisition is unrestricted and open to full and open competition. The North American Industry Classification System (NAICS) Code is 334516 – Analytical Laboratory Instrument Manufacturing, with a size standard of 1000 employees. The Product and Service Code (PSC) is 6550 – In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets.

• Provision of coagulation analyzers on a CPRR basis.

• Support for specific test types (e.g., PT, PTT, D-Dimer, Fibrinogen, Heparin, Factor VIII, etc.) at various MTFs.

• Detailed workloads (Total Tests/Year) are provided for each MTF.

• The contract requires adherence to Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS) provisions and clauses.

• Specific cybersecurity requirements (RMF, ATO, etc.) are detailed, including those for third-party components.

• The contract type will be Firm-Fixed-Price (FFP).

• The period of performance is not explicitly stated but implied by the RFQ issuance date and submission deadline.

• Estimated value is not stated.

• Submission Deadline: Quotations must be received no later than 1:00 p.m. Pacific on Tuesday, June 2, 2026.

• Submission Method: Electronic submission via email to bobbie.s.dobberstein.ctr@health.mil and cc cha-on.p.gordon2.civ@health.mil.

• Evaluation Factors: Award will be made on a "Best Value Tradeoff" basis, considering the following factors:

  1. Technical (Factor 1)
  2. Past Performance (Factor 2)
  3. Information Assurance (Factor 3)
  4. Price (Factor 4)

• Non-price factors (Technical, Past Performance, Information Assurance) combined are more important than Price.

• Quoters rated Unacceptable for Technical or Information Assurance, or Limited Confidence/No Confidence in Past Performance, will not be considered for award.

• Period for Acceptance of Offers: Offerors agree to hold prices firm for 60 calendar days from the date specified for receipt of offers.

• This acquisition is not set-aside for small business concerns; it is an unrestricted procurement.

• Quoters must be an original equipment manufacturer (OEM), authorized dealer, distributor, reseller, or authorized service provider, verified by the OEM.

• The document includes extensive lists of FAR and DFARS provisions and clauses incorporated by reference.

• DBIDS (Defense Biometric Identification System) is required for access control.

• Several attachments are referenced, including a Technical Submission Form, Quote Sheet, and SOW Enclosures (Site Specific Information, CyberLOG-ICS).

• Questions regarding the RFQ must be submitted electronically by email no later than 1300 p.m. Pacific on Thursday, May 15, 2026.

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

This Statement of Work (SOW) outlines the requirements for a Cost-Per-Reportable Result (CPRR) contract for Coagulation analyzers, reagents, and consumables to support military treatment facilities (MTFs).

• The contract will cover one base year and four option years.

• The CPRR price must include all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories, and maintenance necessary for the analyzers to generate reportable results.

• This includes costs for dilutions, repeats, confirmatory testing, quality control, calibration, and correlation studies.

• All necessary maintenance to keep equipment in good operating condition (preventive and repair) is required.

• Training for Government personnel (user-level and advanced super-user) is included.

• Delivery, installation, and removal of laboratory analyzers and peripheral equipment (printers, UPS) are required.

• Analyzers must be new, FDA-approved, and capable of performing tests without third-party reagents.

• Equipment must interface bidirectionally with the electronic health record (EHR) and the Laboratory Information Management System (LIMS).

• The solution must automatically recover from interface downtime without manual intervention.

• The contractor must provide analyzers capable of handling potential volume surges of up to 50%.

• Analyzer systems must use the same reagents, calibrators, and controls.

• The contractor must provide an analyzer grade water system and UPS units for vulnerable instruments.

• The contractor must address hazardous waste characteristics and provide disposal guides.

• Onboard environmental sensors are required to mitigate fire and electrical hazards.

• Data captured by the analyzer software must be accessible for external analysis in an ODBC-compliant format.

• A continuously stocked inventory of consumable supplies is required.

• Emergency supply delivery within 24 hours is required if supplies are defective or delivery fails.

• Equipment's "Procedure Manual" must be provided, formatted per CLSI guidelines.

• Automated analyzers must allow random access and continuous testing.

• Specific features for coagulation analyzers are preferred, including benchtop models, automatic dilutions, on-board reagent storage, and cap piercing.

• The contractor must maintain an overall uptime rate of 95% or better for all analyzers at each MTF.

• Equipment must meet a standard of performance for 30 consecutive calendar days at an effectiveness level of 95% or more for acceptance.

• Downtime for each incident starts when the Government attempts to contact the contractor until the system is operational.

• A minimum of 100 hours of operational use time is required for performance testing.

• The contract includes one base year and four option years.

• The contract supports multiple military treatment facilities (MTFs) listed in the document.

• Installation and transition must be completed within 60 days of award.

• All equipment and reagent kits must be Food and Drug Administration (FDA) approved.

• Contractor personnel must follow MTF security procedures.

• The contractor is responsible for obtaining all permits and approvals.

• The contractor must provide OEM-trained, experienced, English-speaking personnel for service and maintenance.

• A 24-hour technical assistance center with a maximum call-back response time of 2 hours is required.

• Routine equipment repair response time is 24 hours, with on-site service within 24 hours and repair within 48 hours.

• Preventive maintenance calls must align with manufacturer's specifications.

• All test equipment must be calibrated and compliant with relevant standards (JC, CAP, FDA, NIST).

• The contractor must provide service manuals, specifications, schematic diagrams, and parts lists.

• The contractor must comply with applicable DoD Cybersecurity/Risk Management Framework (RMF) requirements.

• Title to the equipment remains with the Contractor.

• The contractor is responsible for removal of equipment at contract expiration at their expense.

• The contractor shall not remove equipment containing personally identifiable information or patient health information from the Government site.

• The contractor must immediately notify BIOMED of any defects or required repairs outside the scope of the contract and provide a cost estimate.

Form / Attachment / Pricing Sheet

This document is a technical submission form for vendors to complete as part of their bid for the Coagulation analyzers contract. It requires vendors to detail how they meet minimum technical requirements and provide supporting information.

• Technical Requirements: Details minimum requirements for coagulation analyzers, including reagents, maintenance, training, delivery, installation, equipment specifications (new, FDA approved, EHR/LIMS interface), data accessibility, reporting capabilities, reagent supply, and disposal of hazardous waste.
• Vendor Submission: Vendors must indicate if they meet each minimum requirement (YES/NO), provide a justification narrative, specify the location of supporting information in their offer (page numbers), and explain any reasons why a minimum requirement cannot be met.
• Installation & Transition: Outlines requirements for installation, site preparation, personnel access, security procedures, cleanup, and validation studies.
• Replacement Parts/Upgrades: Specifies requirements for replacement parts, software revisions, and upgrades.
• Reagent Supply & Delivery: Details requirements for reagent expiration dates, labeling, and delivery timelines.
• Service/Maintenance: Defines requirements for preventive maintenance, corrective maintenance, response times, and technician qualifications.
• Performance Requirements: Includes acceptance testing criteria, such as a 30-day performance standard and a 95% uptime requirement.

This form is critical for bidders to understand the specific technical capabilities and operational requirements for the coagulation analyzers. Completing this form accurately demonstrates compliance with the solicitation's technical specifications and is essential for proposal evaluation.

Form / Attachment / Pricing Sheet

This document, the Medical Device and Equipment Risk Assessment (MDERA) Questionnaire Version 6.4.1, is a required component for vendors as part of the Request for Offer (RFO)/Risk Management Framework (RMF) Change Control Board (CCB) review process. It is used to ascertain security compliance with US Federal Government, Department of Defense (DoD), and Defense Health Agency (DHA) policies and directives. The information gathered serves as a pre-procurement selection tool to support RMF Authorization.

• Vendor Information: Primary and Technical Points of Contact (POC) details.
• System Identification: Technical and regulatory information including device title, description, model, FDA certifications, contract details, and DoD/DHA authorization status.
• Technical Information: Details on system hardware/firmware, operating systems, installed applications, migration paths, user accounts, architecture diagrams, endpoint protection, vulnerability scanning policies, remote access, wireless capabilities, and mass storage.
• Data Processing Capabilities: Information on data processing functions, handling of Electronic Protected Health Information (ePHI)/Personally Identifiable Information (PII), data persistence, input methods, data workflow, and encryption capabilities.

Vendors must complete this questionnaire in its entirety. Failure to disclose all required information or misrepresentation of capabilities will result in the system being ineligible for purchase or a breach of contract. The information provided will identify technical characteristics and determine the level of effort and potential actions required for RMF Assessment from a cybersecurity standpoint. References to external documents or product literature are not acceptable; all fields must be addressed directly within the questionnaire.

Form / Attachment / Pricing Sheet

This document, "CSS Coagulation - Attachment 3 Quote Sheet.xlsx", is a pricing sheet intended for bidders to submit their quotes for coagulation testing services. It outlines the specific tests, quantities, and locations for which pricing is required.

• RFQ Number: HT941026Q2004
• Requirement: DHA HCD-W Coagulation CPRR
• Contracting Office: DHA Healthcare Contracting Division - West
• Quote Sheet Structure: The sheet details required coagulation tests (e.g., Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, D-Dimer) for various Military Treatment Facilities across different networks (Pacific Rim, Indo Pacific, Continental, Central, West).
• Performance Periods: Pricing is requested for the Base period (10/01/2026 - 09/30/2027) and four subsequent Option periods (10/01/2027 - 09/30/2031), plus a final period (10/01/2031 - 03/31/2032).
• Bidder Information: Fields are provided for Quoter Name, Address, Unique Entity ID, CAGE Code, Point of Contact, and payment terms.
• Acknowledgement of Amendments: Space is included to acknowledge receipt of any amendments to the solicitation.
• Price Firmness: Offerors agree to hold prices firm for 60 calendar days.

Bidders must use this sheet to provide detailed pricing for each specified test and location across all performance periods. Accurate completion and submission of this quote sheet are essential for proposal evaluation. It also requires bidders to acknowledge receipt of amendments and agree to hold prices for a specified duration.

Form / Attachment / Pricing Sheet

This document provides site-specific information for various Medical Treatment Facilities (MTFs) related to laboratory equipment, likely for a coagulation testing contract. It details anticipated start dates, equipment requirements, space and power constraints, operational hours, and specific testing needs for each location.

• MTF Locations: Lists numerous military medical facilities across different regions (Indo Pacific, Pacific Rim, Central, Continental, West).
• Equipment Needs: Specifies analyzer quantity, maximum dimensions, and power requirements for each site.
• Site Constraints: Notes available space for new equipment, laboratory hours, and specific site requirements (e.g., no external water source needed, automated benchtop capability).
• Testing Information: Includes details on anticipated tests (PT, aPPT, Fibrinogen, D-Dimer, etc.), how DIC panels are billed, and Quality Control (QC) frequencies.
• Vendor Support: Indicates requirements for onsite vendor support and lot-to-lot assistance.
• Delivery Dates: Provides anticipated start dates for deliveries, with some TBD based on option exercise.

This attachment is crucial for bidders to understand the specific operational environments, technical requirements, and logistical considerations at each potential performance site. It directly informs equipment sizing, power provisioning, installation planning, and service support strategies. The workload data in the second sheet provides an estimate of testing volumes, which is essential for resource planning and pricing.

Questions & Answers / Clarifications

This document provides pre-solicitation questions and answers related to the HT941026Q2004 opportunity, clarifying various aspects of the solicitation, attachments, and requirements.

• Proposal Due Date: Extended to a later date and time (specifics in amendment).
• Option Period Dates: Attachment 3 (Quote Sheet) has been updated with corrected dates for option periods, including Option Period 4.
• Site Transition Goal: The objective is to transition all MTFs by October 1, 2027. Attachment 3 has been updated with "0" quantities for tests for MTFs transitioning after the base period.
• Quality Control (QC) Testing: Specific assays (PT, PTT, Fibrinogen, D-Dimer, Xa) are run every 8 hours. Factor Assay, LAC, and mixing studies are run weekly. LMWH QC is performed as needed.
• Pricing Strategy: Vendors are encouraged to assess site-specific operations to optimize "By the Box" pricing, particularly for lower-volume tests. Billing is based on maximum monthly budget per CLIN.
• Mandatory vs. Preferred Requirements: Vendors should refer to the updated SOW and Site Specific Information spreadsheet for clarity.
• Aptio Line Compatibility: Connection compatibility with the Aptio Line at Nellis AFB is not mandatory and can be adjusted per awardee.
• Technical Submission Scoring: Narrative strength and technical discrimination will be considered in the Technical rating, not just pass/fail.
• Surge Capacity: The requirement for up to 50% surge capacity applies to the aggregate contract volume across all MTFs.
• Country-of-Origin (CoO) Reporting: Detailed CoO reporting is required for hardware, firmware, operating systems, and third-party software components, driven by cybersecurity concerns.
• Information Assurance: An "Unacceptable" Information Assurance rating will make a quote ineligible.
• Award Basis: Contract award will be made on a "Best Value Tradeoff" basis.
• Site-Specific Information: References to specific analyzer makes/models have been removed from the Coagulation SOW – Enclosure A Site Specific Information to prevent vendor preference perception.

Several attachments and documents (Attachment 3 Quote Sheet, Coagulation SOW, Enclosure A Site Specific Information) have been updated based on these clarifications. Vendors should review these updated documents for accurate requirements, dates, and pricing information. The proposal due date has also been extended via amendment.

Other / Unclassified

This document is a "Determination and Findings" (D&F) report justifying the consolidation of coagulation analyzer requirements for twenty-four (24) military treatment facilities (MTFs) within the Defense Health Agency (DHA) Healthcare Contracting Division - West (HCD-W) area of responsibility into a single award contract. Currently, these requirements are managed through eleven (11) separate contract actions, leading to administrative inefficiencies and complex oversight.

• Consolidation Rationale: The DHA seeks to consolidate these requirements to achieve cost savings through volume discounts, improve quality and performance via standardization, and reduce acquisition cycle times.
• Procurement Strategy: The proposed strategy involves a single award contract utilizing a "reagent rental" approach under a cost per reportable result (CPRR) pricing arrangement. This means the analyzer equipment, maintenance, and related services are included at no additional cost as part of the CPRR pricing.
• Market Research Findings: Extensive market research, including industry meetings and Requests for Information (RFIs), indicated that the coagulation analyzer market is dominated by large businesses. No small businesses responded to the RFIs for this requirement.
• Contract Details: The consolidated contract is planned for award by the end of Fiscal Year 2026, with a total delivery period of up to five (5) years and six (6) months (12-month base plus four 12-month option periods).
• Alternatives Considered: The D&F evaluated alternatives such as maintaining the status quo, using multiple-award IDIQs, and consolidated single-award delivery orders under VA FSS, concluding that a single consolidated contract award is the optimal solution.
• Small Business Impact: The DHA has determined that this acquisition is unlikely to involve small business participation due to the nature of the requirement and market research findings.

Form / Attachment / Pricing Sheet

This document, "Attachment 3 Quote Sheet.xlsx", is a pricing sheet for the "DHA HCD-W Coagulation CPRR" requirement under RFQ # HT941026Q2004. It requires bidders to provide pricing for coagulation tests over a base period and four option periods, plus a 6-month extension.

• RFQ Number: HT941026Q2004
• Requirement: DHA HCD-W Coagulation CPRR
• Contracting Office: DHA Healthcare Contracting Division - West
• Pricing Structure: Bidders must provide a "Cost Per Reportable Result" for each listed test.
• Periods of Performance: Pricing is required for:
  • Base Period: 10/01/2026 - 09/30/2027
  • Option Period One: 10/01/2027 - 09/30/2028
  • Option Period Two: 10/01/2028 - 09/30/2029
  • Option Period Three: 10/01/2029 - 09/30/2030
  • Option Period Four: 10/01/2030 - 09/30/2031
  • Option Period 6-Mo Extension: 10/01/2031 - 03/31/2032
• Quoter Information: Fields are provided for Quoter Name, Address, UEI, CAGE Code, POC, Phone, and Email.
• Amendment Acknowledgment: A section to acknowledge receipt of amendments.
• Offeror Agreement: Statements confirming agreement with solicitation terms and holding prices firm for 60 calendar days.

This attachment is critical for bidders to accurately price their proposed services for the coagulation testing requirement. Bidders must complete all relevant fields, including estimated annual test counts (if not provided), cost per result for each test, and ensure their pricing covers the specified base and option periods. The completed quote sheet will form a key part of the proposal submission.

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

This Statement of Work (SOW) outlines the requirements for a Cost-Per-Reportable Result (CPRR) contract for Coagulation analyzers and associated reagents and consumables to support multiple military treatment facilities (MTFs).

• The contract will cover the supply of reagents, standards, quality controls, supplies, and all necessary parts and accessories for the operation of coagulation analyzers.

• It includes all maintenance (preventive and repair) to keep equipment in good operating condition.

• Training for Government personnel (user-level and advanced super-user) is required.

• Delivery, installation, and removal of laboratory analyzers and peripheral equipment (e.g., UPS units) are included.

• The contractor must provide new, FDA-approved equipment and reagents.

• The system must interface bidirectionally with the existing electronic health record (EHR) and Laboratory Information Management System (LIMS).

• The contractor must provide a UPS for instruments vulnerable to power fluctuations.

• Hazardous waste produced by the instruments must be described and managed according to CFR regulations.

• A written guide for proper disposal and care of reagents, consumables, and equipment is required.

• Onboard environmental sensors to mitigate fire and electrical hazards are needed.

• Data captured by the analyzer software must be accessible for external analysis and downloads.

• A continuously stocked inventory of consumable supplies is required.

• Emergency repair service and preventative maintenance are required.

• The contractor must maintain an overall uptime rate of 95% or better for all analyzers at each MTF.

• Equipment must meet a standard of performance for 30 consecutive calendar days at an effectiveness level of 95% or more during an acceptance period.

• Routine maintenance and cleaning are the Government's responsibility.

• The contract includes one base year and four option years.

• The contract covers multiple MTFs, with specific site information to be detailed in an attachment.

• Analyzers must be functioning to provide testing at all locations by 10/01/2027.

• All equipment and reagent kits must be new and FDA-approved.

• The solution must support a surge of up to 50% in volume.

• The contractor must provide a detailed plan for restoration of services and scheduled corrective action/maintenance within 48 hours of initial on-site service.

• The contractor must comply with applicable DoD Cybersecurity/Risk Management Framework (RMF) requirements.

Form / Attachment / Pricing Sheet

This document is a technical submission form for vendors to complete regarding coagulation analyzers. It outlines the minimum requirements for the contract and requires vendors to provide justifications, supporting information locations, and explanations for any unmet requirements.

• General Technical Requirements: Covers reagents, standards, quality controls, supplies, consumables, parts, accessories, and all items necessary for proper operation and reportable results. Includes costs for dilutions, repeats, confirmatory testing, QC, calibration, and correlation studies. Requires maintenance (preventive and repair), training for government personnel, delivery, installation, and removal of equipment. Equipment must be new, FDA-approved, and capable of bidirectional interface with the current electronic health record (EHR) and Military Healthcare System (MHS) Genesis Coding and Compliance Editor (CCE) module. Requires automatic recovery from interface downtime without manual intervention.
• Analyzer Specifications: Details requirements for base equipment, multi-analyzer solutions (same reagents, calibrators, controls), surge capacity (up to 50% increase), and annual volume reviews for potential price adjustments. Includes requirements for analyzer-grade water systems and Uninterrupted Power Supply (UPS) units.
• Environmental and Safety: Addresses minimal exposure to bio-hazardous and chemical materials, waste disposal (compliance with 40 CFR Part 261), proper disposal guides, effluent studies, and onboard environmental sensors.
• Data Accessibility: Mandates open access to all processing data, including timestamps, reagent inventories, patient information, audit trails, and personnel scans. Requires data to be available for full downloads in an Open Database Connectivity (ODBC)-compliant, unencrypted format. A full data dictionary is required.
• Reporting and Supplies: Requires robust reporting capabilities (throughput, transaction times, user metrics, reagent utilization) and a continuously stocked inventory of consumable supplies. Outlines procedures for emergency supply delivery (within 24 hours) and reagent usage tracking.
• Coagulation Analyzer Specifics: Preference for benchtop models, automatic dilutions, on-board reagent storage, shelf-life management, cap piercing, self-contained waste, QC lockout, and reagent sequester. Requires specific performance metrics for reagents and QC.
• Installation and Transition: Covers contractor responsibilities for setup, installation, permits, site preparation, personnel access, security procedures, work area cleanliness, and material storage. Requires validation studies per CLIA/NCCLS standards.
• Training: Comprehensive training for laboratory personnel, including user-level and super-user training. Diagnostics Systems Specialists and Technical Specialists will be available on-site.
• Replacement Parts/Upgrades: Requires ready access to unique/high-mortality replacement parts, OEM certification, and provision of software revisions, updates, and upgrades at no additional cost.
• Reagent Supply and Delivery: Reagents must have expiration dates of at least 6 months (preferably 12 months) from delivery and be certified for use with the provided equipment. Special handling requirements must be clearly labeled.
• Service/Maintenance: Details requirements for Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance. Includes 24-hour telephone availability with a 2-hour callback response time and on-site service within 24 hours for routine repairs, with equipment repair within 48 hours.
• Performance Requirements: Acceptance period begins upon installation, ending after 30 consecutive days of operation meeting technical specifications with at least 95% effectiveness. Instruments must maintain 95% uptime monthly.

This form is critical for bidders to understand the detailed technical specifications and performance requirements for the coagulation analyzers. Vendors must meticulously complete this form to demonstrate their compliance with all minimum requirements, providing specific details on how their proposed solution meets each criterion. Failure to adequately address any section may impact proposal evaluation and award.

Solicitation / RFP / RFQ

This document is a combined synopsis/solicitation (RFQ) for a cost per reportable result (CPRR) contract to provide coagulation analyzers and associated testing services to various military treatment facilities (MTFs). The acquisition is unrestricted and open to full and open competition. The North American Industry Classification System (NAICS) Code is 334516 – Analytical Laboratory Instrument Manufacturing, with a size standard of 1000 employees. The Product and Service Code (PSC) is 6550 – In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets.

• Provision of coagulation analyzers and associated reagents, controls, and consumables.

• Support for a specified list of coagulation tests at multiple MTFs, with varying annual test volumes.

• Compliance with Defense Health Agency (DHA) cybersecurity requirements, including Risk Management Framework (RMF) processes, and potential for full Assess and Authorize (A&A), Assess and Incorporate (A&I), or Assess and Use (A&U) certifications.

• Maintenance of Information Assurance (IA) for all offered systems and components.

• Contract Type: Firm-Fixed-Price (FFP).

• Period of Performance: Not explicitly stated, but includes options for increased quantity.

• Estimated Value: Not stated.

• Submission Deadline: Quotations must be received no later than 1:00 p.m. Pacific on Monday, April 30, 2026.

• Submission Method: Electronic submission via email to bobbie.s.dobberstein.ctr@health.mil and cc cha-on.p.gordon2.civ@health.mil.

• Evaluation Factors: Award will be made on a "Best Value Tradeoff" basis, considering the following factors:

  1. Technical (Factor 1)
  2. Past Performance (Factor 2)
  3. Information Assurance (Factor 3)
  4. Price (Factor 4)

• Evaluation Criteria: Factors 1 and 2 are considered approximately equal in importance and combined are more important than Factor 3. Factors 1, 2, and 3 combined are more important than Factor 4 (Price). Quoters rated Unacceptable for Technical or Information Assurance, or Limited/No Confidence in Past Performance, will not be considered for award.

• This acquisition is not set-aside for small business concerns.

• Quoters must be an original equipment manufacturer (OEM), authorized dealer, distributor, reseller, or service provider, verified by the OEM.

• Questions Deadline: Questions must be submitted via email by 1300 p.m. Pacific on Wednesday, April 8, 2026.

• Attachments:

  • Attachment 1 – SOW (including Enclosures A & B for Site Specific Information and CyberLOG-ICS)
  • Attachment 2 - Technical Submission Form
  • Attachment 3 – Quote Sheet

• DBIDS: Vendors will need to comply with the Defense Biometric Identification System (DBIDS) for access control.

Form / Attachment / Pricing Sheet

This document, "Coagulation SOW - Enclosure A Site Specific information.xlsx", provides detailed site-specific information for various Medical Treatment Facilities (MTFs) related to a potential coagulation testing equipment procurement. It outlines requirements and conditions for each location to assist bidders in understanding the operational environment and specific needs.

• MTF Name and Location: Identifies each facility.
• Network: Categorizes facilities by region (e.g., Indo Pacific, Pacific Rim, Continental).
• Anticipated Start Date of Deliveries: Provides estimated timelines for equipment delivery.
• Analyzer Quantity: Specifies the number of analyzers required per site.
• Space Dimensions: Details the maximum physical space available for analyzer equipment.
• Power Requirements: Outlines the available power supply at each site.
• Site-Specific Requirements: Lists any unique needs, such as automation, clot detection, sample identification, or specific reporting.
• Room for New Equipment: Indicates if there is sufficient space to accommodate new equipment alongside existing systems.
• Laboratory Hours of Operation: Specifies the operating hours of the laboratories.
• DIC Panel Information: Details anticipated tests for DIC panels and billing practices.
• Reagent Grade Rinse Water Access: Confirms availability of necessary water supply.
• Onsite Vendor Support: Specifies requirements for vendor support, including lot-to-lot assistance and reporting.

This attachment is crucial for bidders to assess the feasibility and specific requirements for each potential installation site. It highlights critical logistical, technical, and operational considerations, including space, power, existing infrastructure, and support needs, which will directly impact proposal development, equipment design, and pricing.

Form / Attachment / Pricing Sheet

This document, the Medical Device and Equipment Risk Assessment (MDERA) Questionnaire, Version 6.4.1, is a required component for vendors submitting offers as part of the Request for Offer (RFO) process. It is used to assess security compliance with US Federal Government, Department of Defense (DoD), and Defense Health Agency (DHA) policies and directives, specifically for the Risk Management Framework (RMF) Change Control Board (CCB) review.

• Vendor Information: Requires primary and technical points of contact.
• System Identification: Details about the medical device/equipment, including title, version, description, model, alternate names, category, software release/EOL dates, FDA/regulatory certifications, contract information, DoD/DHA authorization status, and physical testing location.
• Technical Information: Covers system hardware/firmware, operating systems (including proprietary OS and underlying technology), installed applications, migration plans, user accounts, and system architecture diagrams.
• Security Features: Addresses endpoint protection (anti-virus, HBSS, HIPS), vulnerability scanning policies, remote access capabilities, wireless capabilities (IEEE 802.11, Bluetooth), mass storage (USB flash drives), and data processing capabilities (including ePHI/PII handling).

Completion of this questionnaire is mandatory for all medical systems/devices to meet DoD cybersecurity and NIST standards. Failure to provide complete and accurate information, or misrepresentation of capabilities, will result in the system being ineligible for purchase or could lead to contract breach and cancellation. The information gathered helps identify technical characteristics, assess cybersecurity posture, and determine the level of effort required for RMF Authorization. This document is crucial for vendors to understand the detailed technical and security requirements for medical devices and equipment intended for use within the DHA environment.

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

This SOW outlines the requirements for a Cost-Per-Reportable Result (CPRR) contract for reagents and consumables for laboratory coagulation analyzers across multiple military treatment facilities (MTFs).

• Services: Provision of all reagents, standards, quality controls, supplies, and consumables necessary for the operation of contractor-provided equipment to generate reportable results. This includes costs for dilutions, repeats, confirmatory testing, and quality control.

• Equipment: Delivery, installation, and removal of new laboratory analyzers and necessary peripheral equipment (e.g., printers, UPS). All equipment must be FDA-approved and capable of interfacing bidirectionally with the existing electronic health record (EHR) and Military Healthcare System (MHS) Genesis.

• Maintenance: Comprehensive maintenance, including preventive maintenance and repairs, to keep equipment in good operating condition.

• Training: User-level and advanced super-user training for government personnel.

• Reporting: Monthly reports for invoicing, detailing actual test quantities performed by each site. Data must be accessible for external analysis and download in an ODBC-compliant format.

• Surge Capacity: Contractor must provide capacity for up to a 50% surge in volume.

• Hazardous Waste: Description of hazardous waste characteristics and disposal procedures according to CFR Title 40.

• Uptime: A minimum uptime rate of 95% for all analyzers at each MTF, calculated on a rolling 6-month basis.

• Acceptance Testing: Equipment must meet a standard of performance for 30 consecutive calendar days with an effectiveness level of 95% or more after installation.

• Response Times: 2-hour callback response for technical assistance, 24-hour on-site service for routine repairs, and equipment repair within 48 hours.

• Reagent Dating: Reagents should have expiration dates of at least 6 months (preferably 12 months) from delivery.

• Period: One base year with four option years.

• Locations: Naval Hospital Bremerton, Naval Hospital Camp Pendleton, 673rd Medical Group (JBER), 56th Medical Group (Luke AFB), Madigan Army Medical Center, Naval Medical Center San Diego, 99th Medical Group (Nellis AFB), 60th Medical Group (Travis AFB), Tripler Army Medical Center, Robert E. Bush Naval Hospital Twentynine Palms, Weed Army Community Hospital. The government reserves the right to add additional MTFs.

• Installation Deadline: All analyzers must be functioning and live by 10/01/2027.

• All equipment must be new.

• Analyzers must be capable of performing tests without third-party reagents.

• Interface with MHS Genesis must be validated within 30 days of installation.

• Contractor must provide continuously stocked inventory of consumable supplies.

• Compliance with DoD Cybersecurity/Risk Management Framework (RMF) requirements.

• Title to equipment remains with the Contractor.

Form / Attachment / Pricing Sheet

This document provides site-specific information for multiple Medical Treatment Facilities (MTFs) related to analyzer equipment, including network, anticipated start dates, equipment dimensions, power requirements, and site-specific needs. It is intended to help bidders understand the logistical and technical requirements for each location.

• Madigan Army Medical Center, JBLM, WA: Indo Pacific network, start dates 10/1/2026 or 10/1/2027, 1 analyzer, specific dimensions for STA R Max and STA Compact Max, 100-240V power, space available for STA Compact Max only.
• Naval Hospital Camp Pendleton, CA: Pacific Rim network, start date 2/1/2027, 2 analyzers, 39.2x99.6x43.3 dimensions, 120V/60Hz power, space available.
• Naval Hospital Bremerton, WA: Pacific Rim network, start date 10/1/2026, 1 analyzer, 20.5 x 44.5 x 19.5 in dimensions, 120V/60Hz power, specific requirements for automation, clot detection, etc., space available.
• Robert E. Bush Naval Hospital, Twentynine Palms, CA: Pacific Rim network, start date 10/1/2026, 2 analyzers, 40in x 96in x 30in dimensions, 120V/60Hz power, no external water source required, space available.
• 99th Medical Group, Mike O'Callaghan MMC, Nellis AFB, NV: Continental network, start dates 11/17/2026 or 11/17/2027, 1 CS 2500 and 1 CS 5100 analyzers, specific dimensions for each, 120V/60Hz power, connection compatibility with Aptio Line, space available.
• 60th Medical Group, David Grant MC, Travis AFB, CA: Central network, start date 9/1/2027, 2 analyzers, 6ft x 4ft table area per unit, facility can supply max power, space may be insufficient if multiple contracts awarded.
• Weed Army Community Hospital, Fort Irwin, CA: West network, start date 12/30/2026, 1 analyzer, 32x33x29 dimensions, 110V power, space available.
• Naval Medical Center San Diego, CA: Pacific Rim network, start dates 10/1/2026 TBD, 2 analyzers, 6ft x 3ft table area per unit, facility can supply max power, specific requirements for automation, clot detection, onboard QC/patient databases, space available.
• Tripler Army Medical Center, HI: Indo Pacific network, start dates 10/1/2026 TBD, 2 analyzers, STA Compact Max dimensions, 95V/115V/230V power, space available.
• 56th Medical Group, Luke AFB, AZ: Central network, start date 9/11/2027, 1 analyzer, 27.4"H x 21.1"W x 25.5"D dimensions, 120V/60Hz power, space available.
• 673rd Medical Group, JBER, AK: Central network, start date 8/1/2027, 1 analyzer, 39.2x99.6x43.3 dimensions, 120V/60Hz power, space available.

This attachment is crucial for bidders to assess the feasibility of providing equipment and services at each specified MTF. It details physical space constraints, power availability, and specific operational requirements that may influence equipment selection, installation planning, and overall proposal strategy. The "Estimated Workload" sheet (though not detailed here) likely provides volume data critical for understanding the scale of services required at each location.

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

This Statement of Work (SOW) outlines the requirements for a Cost-Per-Reportable Result (CPRR) contract for Coagulation analyzers, including reagents and consumables, to support multiple military treatment facilities (MTFs).

• The contract will provide Coagulation analyzers and associated supplies to 12 specified MTFs, with the potential to add more.

• The CPRR price must include reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories, maintenance, training, installation, and peripheral equipment (printers, UPS).

• Equipment must be new, FDA-approved, and capable of performing tests without third-party reagents.

• Analyzers must interface bidirectionally with the existing military Laboratory Information Management System (LIMS) and Electronic Health Record (EHR).

• The contractor must provide solutions capable of handling potential future surges in volume (up to 50%).

• Hazardous waste produced by the instruments must be described, including toxicity, ignitability, corrosiveness, and reactivity.

• The contractor must provide a written guide for proper disposal and care of reagents, consumables, and equipment, along with effluent study reports.

• Access to all processing data from lab analyzers is required for external analysis and downloads.

• A continuously stocked inventory of consumable supplies is required to ensure uninterrupted equipment operation.

• Emergency supply delivery within 24 hours is required if supplies are defective or routine delivery fails.

• The contractor must provide a means of tracking reagent usage and level detection.

• Equipment must be maintained in good operating condition, including preventive maintenance and repairs.

• User-level and advanced training for government personnel is required.

• Analyzers must meet specific technical requirements, including random access, continuous testing, and flagging capability.

• Equipment must achieve an overall uptime rate of 95% or better for all analyzers at each MTF.

• Performance testing requires a minimum of 100 hours of operational use time.

• Equipment must meet a standard of performance for 30 consecutive calendar days with an effectiveness level of 95% or more.

• The contract includes one base year and four option years.

• Performance will occur at multiple specified military treatment facilities (MTFs).

• Deliveries of analyzer equipment and supplies are anticipated to begin and end off the current existing contract for each MTF.

• All analyzers must be functioning by 10/01/2027.

• All equipment and reagent kits must be Food and Drug Administration (FDA) approved.

• Equipment must be capable of interfacing with the current EHR bidirectionally.

• The contractor must provide onboard environmental sensors to mitigate fire and electrical hazards.

• The contractor must provide a UPS for instruments vulnerable to power fluctuations.

• The contractor must ensure minimal exposure to bio-hazardous and chemical material.

• The contractor must provide a written guide describing proper disposal and care of all reagents, consumables, and equipment.

• Installation and transition services are required, including setup, installation, and maintainability.

• The contractor is responsible for obtaining all permits and approvals.

• Contractor personnel must follow MTF security procedures.

• The contractor must provide upgrades to hardware and software at no additional charge.

• Ancillary support equipment must be provided, installed, and maintained.

• The contractor is responsible for repair or replacement of damaged Government-owned property due to negligence.

• Service/Maintenance includes PM, CAL, ST, and corrective maintenance.

• A technical assistance center must be available 24 hours per day.

• Routine equipment repair service must be provided during laboratory operational hours.

• Emergency equipment repair must be provided within 24 hours of receipt of an order.

• The contractor must comply with DoD Cybersecurity/Risk Management Framework (RMF) requirements.