FY26 Lab Consolidation for Coagulation CPRR Effort

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.

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, "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.

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.

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.

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.