The Medical Readiness Contracting Office West (MRCO -W) is issuing this Combined Synopsis/ Solicitation for a cost-per-reportable-result agreement to conduct Hematology Testing for the CBC, Reticulocyte Counts, and Body Fluid Count in support of the BAMC.

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

To provide Hematology instrumentation and reagents for the Hematology mission at Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network.

• Provide Hematology testing under a Cost Per Reportable Result (CPRR) agreement.

• Includes equipment, reagents, tools, materials, training, peripherals, UPS, Robotic Automation System integration, Automated Integrated Track System, and Automated Post-analytical system.

• Analyzers to be located in three separate locations: Main Core Hematology Laboratory, BAMC Apheresis/Cell Therapy Clinic, and Akeroyd Blood Donor Center.

• Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials.

• Solution must provide redundancy in the Main Core Laboratory, training, supplies, unscheduled maintenance, and preventive maintenance.

• Initial Method Validations required per CLIA/NCCLS/DPALS QM guidelines.

• Contractor responsible for maintenance service, on-site repair, and parts to maintain a minimum 98% uptime.

• All testing materials must be FDA approved.

• Specific requirements for Core Laboratory (e.g., CBC analyzers, pre/post-analytic processing, automation line integration) and Ancillary Sites (Apheresis/Cell Therapy Clinic, Akeroyd Blood Donor Center).

• Detailed specifications for CBC analyzers, including throughput, linearity, and required test parameters (Table 1 & 2).

• Requirements for CBC Differential Instrument System, Slidemaker/Stainer System, and Information Technology and Data Management System in the Main Core Laboratory.

• Includes IT services, contract management, and various IT support scopes (Service Desk, Database/Application/Web Development, Identity Management, Data Center Operations, Information Assurance, Network Operations, Telecommunications, Clinical Informatics, Information Business Operations).

• Detailed security requirements including personnel investigations, facility clearance levels, and cybersecurity compliance (NIST SP 800-171, RMF).

• Reagents must support 24/7 BAMC mission, have minimum 500 tests per pack, and 60-day open stability. Concentrated Reagent Delivery System and reagent management technology required.

• Quality Control materials must be 3-level, sufficient for daily testing, with minimum 7-day open stability and real-time QC peer group data upload.

• Minimum 98% uptime for all instrumentation.

• Daily instrument maintenance downtime not to exceed 20 minutes.

• Service technician on-site within 24 hours for routine repairs, 4 hours for critical Core Lab CBC analyzer failures.

• Equipment repaired within 48 hours of on-site response (4 hours for Core Lab CBC analyzers).

• Monthly Contractor Performance Reports (CPR) required.

• Period of Performance not explicitly stated, but implies ongoing service.

• Place of Performance: Brooke Army Medical Center (BAMC) / Joint Base San Antonio (JBSA), TX and its outlying clinics/healthcare network.

• Delivery locations specified for BAMC and Akeroyd Blood Donor Center.

• Contractor personnel require Tier 1 investigation or higher; SECRET facility clearance may be required.

• Compliance with DoD 8140.01 for baseline certifications.

• Adherence to DHA IT enterprise processes, procedures, standards, and tools.

• No cross-teaming at prime or subcontractor level.

• Training for clinical staff and two primary operators per major analyzer.

• Method validation/verification in accordance with CLIA, NCCLS, DPALS QM, and Department of Pathology policies.

• Monthly invoices and quarterly itemized summaries required.

• MSDSs for reagents must be provided.

Form / Attachment / Pricing Sheet

This document is a "Risk Management Cybersecurity Assessment Questionnaire" required by Defense Logistics Agency Troop Support (DLA-TS) for all Medical Systems/Devices. Its purpose is to ascertain security compliance with Federal, DoD, and DHA directives and policies, and to support stakeholders in achieving an Authorization Certificate. Failure to meet cybersecurity requirements or timelines may result in denial of an Authority to Operate (DATO).

The questionnaire collects detailed information about the medical device, including:

• Preparer and System Identification (name, acronym, FDA number, functionality, mode of operation).
• Electronic Protected Health Information (ePHI) handling and Social Security number processing.
• Department of Defense (DoD)/Defense Health Agency (DHA) Authorization status.
• Data Processing Capabilities (Receive, Process, Store, Route, Display, Transmit).
• Data Transmitting Mechanisms (e.g., generating reports, recording data, wired/wireless transmission).
• Operating System (OS) details (Microsoft, Linux/UNIX, proprietary, etc.).
• Relational Database Management System (RDBMS) information.
• Ports & Protocols used.
• Antimalware support.
• Public Internet connectivity.
• OS Lifecycle Support.
• IPv6 Capability.
• Automatic Logoff and DoD Warning Banner features.
• Medical Device Architecture Diagrams (simple and complex topology).
• System Identification Questions covering Confidentiality, Integrity, Availability, Non-Repudiation, Data at Rest (DAR), and Data in Transit (DIT).
• Test Environment instances.
• Operating System Inventory and Primary Application details (software, virtualization, web server, browsers, backward compatibility, licensing, network protocols, database engine, DNS integration, automation support, compilers).
• Administrator Account, Default Passwords, Shared User IDs, Unused Accounts, User Interface Protection, User Privilege Levels, Unrestricted Administrative Account, Software Installation, Other Platforms Supported, Mobile Code, OS/DB/WEB Server/Application separation.
• Cryptographic and Hash Algorithm support (SHA-256, etc.).
• Security Capability Reconfiguration.
• Application Development Environment details.
• Hardware/Firmware and Software Inventory.
• Physical/Logical Topology Diagrams with external interfaces and data flow.
• Essential Services, Ports/Protocols, Processes, and File System interfaces.
• Group Policy Objects (GPO) compliance for Microsoft Windows.
• Intelligent Platform Management Interfaces (IPMI) support.
• Authentication and Auditing capabilities.
• BIOS Firmware details.
• Remote Access capabilities.
• Vulnerability Management plan.
• Antivirus/Antimalware practices.
• Data at Rest (DAR) and Data in Transit (DIT) encryption details.
• Availability and IPv6 compliance documentation.
• Host-Based Intrusion Prevention System (HIPS) and Host Based Security System (McAfee HBSS) support.
• Intrusion Detection/Prevention System false positives.
• Medical System/Device Recovery/Loss, System Back-up, System Recovery, and Secure Shutdown procedures.
• Medical System/Device Standards Conformance Statements.
• Wireless communication details (IEEE 802.11, Bluetooth, ZigBee, etc.).
• Physical Safeguards and System/Application Hardening.
• Commercial Point of Contact (POC) information.

Vendors must complete this questionnaire thoroughly and accurately. The information provided is critical for the government's assessment of the medical device's cybersecurity posture and its ability to meet required standards. This directly impacts the vendor's ability to achieve an Authorization to Operate (ATO) and participate in the opportunity. The detailed technical information required will inform proposal development, particularly regarding security features and compliance.

Statement of Work (SOW)

To provide Hematology instrumentation and reagents for the Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network under a Cost Per Reportable Result (CPRR) agreement.

• Instrumentation & Reagents: Provide hematology analyzers, reagents, consumables, tools, materials, training, peripherals, UPS, robotic automation integration, automated track systems, and post-analytical systems.

• Locations: Instrumentation required at three locations: Main Core Hematology Laboratory (BAMC), BAMC Apheresis/Cell Therapy Clinic, and Akeroyd Blood Donor Center.

• Services: Includes delivery, installation, calibrators/standards, reagents/reagent packs, quality control materials, training, supplies, unscheduled maintenance, and preventive maintenance.

• Method Validation: Initial method validations per CLIA/NCCLS/DPALS QM guidelines, including correlation, linearity, precision, carry-over, reference range validation, tube conversion, and blood/body fluid validations.

• System Requirements: Analyzers must be fully automated, discrete, random-access with STAT capabilities. Core Laboratory requires system redundancy and a fully automated pre- and post-analytical system. Ancillary sites require specific throughput and parameters.

• IT & Data Management: Requires a data management system (middleware) compatible with MHS Genesis, capable of managing critical values, delta checks, and supporting remote review stations.

• Other Requirements: Includes waste disposal confirmation, analyzer decontamination, instrument removal, and FDA-approved testing materials.

• Minimum 98% uptime for all instrumentation.

• Delivery within 90 calendar days of contract award.

• On-site service technician within 24 hours for Core Laboratory equipment, with repairs completed within 48 hours.

• Emergency repair for Core Laboratory CBC analyzers within 4 hours, with at least one analyzer operational within 8 hours.

• Reagent open stability: minimum 500 tests per pack, 60-day open stability.

• Quality control material open stability: minimum 7 days.

• Period: Not explicitly stated, but implies ongoing service.

• Place: Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX.

• Contract Type: Cost Per Reportable Result (CPRR).

• IT Security: Contractor personnel require Tier 1 investigation or higher, and may require SECRET clearance depending on Task Orders (TOs).

• Training: On-site and online operator training for clinical staff, plus training for two primary operators at the contractor's training site.

• Reporting: Monthly invoices, itemized charges, quarterly billing summaries, and monthly Contractor Performance Reports (CPRs).

• Cross-teaming: Not permitted at prime or subcontractor level.

Solicitation / RFP / RFQ

This solicitation seeks a cost-per-reportable-result agreement for hematology testing services. The services include reagents, instrument/equipment, consumables, controls, and maintenance for hematology testing at the DPALS Core Laboratory, Apheresis Cellular Therapy Clinic, and Akeroyd Blood Donor Center within Brooke Army Medical Center (BAMC), Fort Sam Houston, TX.

• Provision of reagents, instrument/equipment, consumables, and controls for hematology testing.

• Maintenance of furnished equipment with a minimum 98% uptime.

• Provision of necessary new equipment, replacing obsolete items at no additional cost.

• Operator training slots for major analyzers and automated systems.

• Testing includes CBC, Reticulocyte, Residual Leukocyte, and Body Fluid Counts.

• FDA-approved testing materials.

• Specific analytical measurement for leukoreduction in blood establishments.

• RMF Compliance and integration with MHS Genesis.

• Contract Type: Firm Fixed Price.

• Period of Performance: 1 October 2026 through 30 September 2031 (with potential for option periods extending through 30 September 2031).

• NAICS Code: 325413.

• The contract may include options, extending the total duration up to 60 months.

• Offer Due Date: 15 April 2026, 1:00 PM, Central Standard Time.

• Offers to be submitted via email to medina.l.woodson.civ@health.mil and salameya.paulouskaya2.civ@health.mil.

• Questions Deadline: 7 April 2026, 4:00 PM, Central Standard Time, submitted in writing.

• Evaluation Process: Lowest Price Technically Acceptable (LPTA).

• Award Basis: Responsible offeror with the lowest evaluated price meeting acceptability standards.

• Evaluation Factors: Technical Capability, Risk Management Framework (RMF) Compliance, Military Health System (MHS) Capability, and Price.

• Technical Capability will be evaluated across four subfactors: Instruments/Equipment and Reagents/Consumables, Service and Maintenance, Training, and Delivery/Installation.

• Award will be made on an all or none basis.

• The acquisition is currently listed as Unrestricted.

• Offerors must be registered in the System for Award Management (SAM).

• Attachments include Statement of Work (Attachment A), Pricing Matrix (Attachment B), and RMF-related documents (Attachments C1, C2, C3).

• Unique Item Identification (UII) is required for items with a Government unit acquisition cost of $5,000 or more, and for specific items less than $5,000 as identified in the schedule.

• Payment and invoicing will be processed through Wide Area WorkFlow (WAWF).

Form / Attachment / Pricing Sheet

This document, Exhibit 1, outlines the Risk Management Framework (RMF) Assessment Timeframes. It details the required actions and their associated timelines for both the vendor and the Government, following contract or order issuance. The document specifies that if the Government experiences delays, the vendor would be granted additional time for future actions equivalent to the Government's delay.

Vendor Requirements & Timeframes:

• Contact Gov POC: 10 business days post award
• Hardware/Software/Architecture Documents: 15 business days post award (Initial Draft), 20 business days post award (Final)
• RMF Documentation Production: 6 weeks post award
• Technical Nessus Scans: 1 month post award
• Technical STIG Checklists: 1 month post award
• Technical SCAP: 1 month post award

Government Requirements & Timeframes:

• Kickoff Meeting: 15 business days post award
• Security Assessment Plan Generation: 20 business days post award (Initial Draft), 30 days post award (Final)
• RMF Templates sent to Vendor: 5 business days post vendor initial contact
• Copies of Applicable STIGs sent to Vendor: 17 business days post award (Initial Draft), 30 days post award (Final)
• Authorization to Operate (ATO-C) Recommendation: Submitted to 3rd party validator 2 weeks after final documentation/technical scans received.
• Independent Verification and Validation (IV&V) Scheduling: Scheduling request to 3rd party validator 3 weeks after final documentation/technical scans received.

This attachment is crucial for bidders as it clearly defines the expected timelines for critical RMF assessment activities. Understanding these timeframes is essential for project planning, resource allocation, and ensuring compliance with the contract requirements. It highlights the vendor's responsibilities and the government's role in the RMF process, impacting the overall project schedule and execution.

Form / Attachment / Pricing Sheet

This document is Attachment B, a Pricing Worksheet for Hematology Testing, associated with solicitation W81K00-26-Q-A080. Bidders are expected to use this worksheet to provide their pricing for the services outlined.

• CLINs (Contract Line Item Numbers): The worksheet details various services under specific CLINs, including Hematology Testing (CPRR), CORE Laboratory, Apheresis Cell Therapy, Akeroyd Blood Donor Center, RMF Compliance, and MHS Genesis.
• Ordering Periods: Pricing is requested for a Base Year and four Option Years.
• Quantities and Unit Price: Columns are provided for Maximum Quantities (specified as 12 Months for all CLINs) and Unit Price, which bidders must complete.
• Total Calculation: The worksheet includes fields for calculating the Total cost per CLIN and for each ordering period, as well as a grand total.

This pricing worksheet is critical for bidders to accurately and competitively price their proposed services. Bidders must complete all relevant fields, including unit prices, to enable the government to calculate the total cost for the Base Year and all Option Years. Failure to provide complete and accurate pricing may impact proposal evaluation.

Form / Attachment / Pricing Sheet

This document outlines the Defense Health Agency (DHA) Cyber Logistics (CyberLOG) Cybersecurity/Risk Management Framework (RMF) Requirements. It details the cybersecurity standards and processes that vendors must adhere to when providing equipment, systems, and software to the DHA.

• General Overview of DHA Cybersecurity Requirements: Covers new equipment/product systems, pricing for cybersecurity, and maintenance/upgrades.
• DHA Cybersecurity/Risk Management Framework (RMF) Requirements: Details system security requirements, RMF assessment timeframes, Assessment and Authorization (A&A) processes, and privileged user training/certification requirements.
• Cybersecurity Regulations and Guidance: Lists applicable US Laws, OMB publications, NIST publications, FIPS, and DoD instructions relevant to cybersecurity.
• Warranty and Post-Warranty Service Maintenance Agreement Cybersecurity Requirements: Outlines ongoing cybersecurity maintenance, monitoring, and risk management obligations.

This document is critical for bidders as it defines the cybersecurity compliance and RMF processes that must be integrated into their product offerings and service delivery. It specifies requirements for:

• Patching and updating systems.
• Cybersecurity maintenance for a minimum of six years.
• Vulnerability scanning and reporting (NESSUS, SCAP, STIGs).
• Obtaining Authority to Operate (ATO) or Approval to Operate (APL).
• Personnel training and certification (e.g., IAT Level I, Cyber Awareness Training, PII, HIPAA).
• Adherence to specific DoD and NIST cybersecurity standards.

Bidders must understand and plan to meet these requirements to successfully bid on and perform contracts involving DHA systems and equipment.