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The Medical Readiness Contracting Office West (MRCO -W) is issuing this Sources Sought for a cost-per-reportable-result agreement to conduct hematology testing for the CBC, Reticulocyte counts, and Bo... The Medical Readiness Contracting Office West (MRCO -W) is issuing this Sources Sought for a cost-per-reportable-result agreement to conduct hematology testing for the CBC, Reticulocyte counts, and Body Fluid Count in support of the Core Laboratory in Fort Sam Houston, Texas. Required assays are listed below. A base period of performance from 01 October 2026 through 30 September 2031 will be required for this action. THIS IS NOT A SOLICITATION ANNOUNCEMENT – This is a Sources Sought Notice and is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement. The Government will use responses to this notice in formulating its acquisition strategy. If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole- source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. MRCO-W is seeking the following information (please answer paragraph below with your response): Company name, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small. Capability Statement (limited to ten pages), describing how your company meets the objectives below, providing additional proof (such as FDA approval) where appropriate: Our customer, the Department of Pathology Core Laboratory at BAMC requires the following reagents, consumables, calibrators, controls: Requirements of Services to be provided: Hematology analyzers – The contractor must provide individual analyzers that are fully automated discrete random-access analyzers capable of performing hematologic analysis of blood and body fluids, as indicated, as well as provide for linear integration of testing systems with slidemaking and staining, digital imagery analysis, and middleware. The analyzers must attach to existing total laboratory automation with bi-directional sample delivery/retraction, to leverage automation storage, or have sample archiving and storage. Bi-directional functionality is preferred. The analyzers shall be located in (3) three separate locations within Brooke Army Medical Center and Joint Base San Antonio: 1) BAMC Main Core Hematology Laboratory; 2) BAMC Aphersis/Cellular Therapy Clinic; 3) Akeroyd Blood Donor Center at Fort Sam Houston The analytical, Pre/Post analytical systems, and total number of analyzers shall be determined by the section’s annual volume, minimum throughput, required test parameters, and slidemaker/stainer, archive/storage, IT requirements, and operational hours. All instrumentation and reagents must be FDA approved. Salient Characteristics - Minimum throughput per location: Main Core Laboratory: 200 tests per hour; triple redundancy required (throughput includes primary and secondary systems) Aphersis/Cellular Therapy Clinic: 60 per hour (primary only) Akeroyd Blood Donor Center: 60 tests per hour (primary only) Salient Characteristics - Annual Volume Requirements (listed below in Tables 1 – 2): Annual volumes may fluctuate within +/- 5% of stated volumes in Tables 1 – 2. Salient Characteristics - Clinical Parameters: Main Core Hematology Laboratory: Measured Hematocrit required. Must achieve HCT linearity (Analytical Measurement Range) of 0.0 – 75.0% and a Reportable Range (Limit of Quantitation) of 0.1 – 75.0%. Ability to identify immature granulocytes per CBC differential analysis. Ability to identify nucleated RBCs per CBC analysis to include anemia management parameters, such as the reticulocyte hemoglobin to efficiently screen for anemia, and immature reticulocyte fraction. Ability to identify immature platelet fraction and provide fluorescent platelet count for low platelet counts. Instrument must provide platelet enumeration using a methodology that would reduce the number of platelet flags requiring manual confirmatory procedures. Dual platelet methodologies are preferable in order to reduce manual confirmations with extended platelet parameters for the determination of thrombopoiesis. Must achieve PLT linearity (Analytical Measurement Range) of 0 – 5000 x 10^3/µL and a Reportable Range (Limit of Quantitation) of 2 – 5000 x 10^3/µL. Additional Main Core Hematology Laboratory Requirement Only Instrument must provide body fluid cell enumeration with the large linear range with the following parameters: WBC, RBC, and Total nucleated count with a 2-part differential (polymorphonuclear %/# and mononuclear %/#) with each body fluid analysis for the following types: Serous Synovial Cerebrospinal Fluid System should have the lowest possible linearity on WBC-BF and Total Nucleated Count-BF linearity (Analytical Measurement Range) on all body fluids of 0.000 – 10.000 x 10^3/µL and a Reportable Range (Limit of Quantitation) of 0.003 – 10.000 x 10^3/µL. Must achieve RBC-BF linearity (Analytical Measurement Range) on all body fluids of 0.000 – 5.000 x 10^6/µL and a Reportable Range (Limit of Quantitation) of 0.002 – 5.000 x 10^6/µL. Instrumentation is required to be physically attached to existing, or future, total laboratory automation lines. Field engineers must assist in laboratory reorganization that requires movement of instruments. Clinical parameters – Apheresis/Cellular Therapy Clinic and Akeroyd Blood Donor Center Measured Hematocrit required. Must achieve HCT linearity (Analytical Measurement Range) of 0.0 – 75.0% and a Reportable Range (Limit of Quantitation) of 0.1 – 75.0%. Must achieve WBC linearity (Analytical Measurement Range) 0.0-440.0 x 10^3/µL and a Reportable Range (Limit of Quantitation) of 0.04 – 440.0 x 10^3/µL. Must achieve PLT linearity (Analytical Measurement Range) of 0 – 5000 x 10^3/µL and a Reportable Range (Limit of Quantitation) of 2 – 5000 x 10^3/µL. Akeroyd Blood Donor Center instrument must have blood bank software for donor testing and provide residual WBC count when analyzing red cell and platelet product in blood bank mode. Required test parameters for Apheresis and Cellular Therapy and Akeroyd Blood Donor Center listed below in Table 4. CBC Differential Instrument System requirements – Main Core Hematology Laboratory only: Integrated digital imaging device for automated digital cell morphology required for whole blood and body fluids; sufficient to automate the performance of manual differentials and cell counts; must connect directly to analytical instrument line. The system must provide automated slide evaluation using photomicroscopy with computerized image analysis of photomicrographs. The contractor must provide a minimum of (12) twelve remote review software packages for the system, providing for remote review of cell morphology by clinical staff not collocated within the main laboratory. Slidemaker/Stainer System requirements – Main Core Hematology Laboratory only: Must be physically connected to the total laboratory automation line to include direct connection to the CBC analyzer and digital imaging device. The slide-maker/stainer should be integrated with analyzer decision rules to reduce operator hands-on intervention and should act as part of line and independent from line as needed. Automated slidemaker and slidestainer for smears with minimum throughput of 75 tests per hour. System redundancy is required. Daily system maintenance should not exceed 20 minutes. Must have ability to differentiate stat from routine smears. Must have onboard decision-making capabilities which initiate preparation of smears based on specific analysis results and/or user-defined criteria. Positive sample identification prior to smear preparation required. Automated slide stainers must use a Wright-Giemsa or Wright stain. If the stains provided by the Contractor are deemed insufficient by the Medical Director, the Contractor must provide at no additional cost an alternative stain from a 3rd party source that is acceptable to the Medical Director. Pedestal(s) and/or carts capable of supporting each workcell system as appropriate, to include computer terminals or other automated instruments/peripherals as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance). Peripherals, to include Uninterruptable Power Sources (UPSs), electrical line conditioners as required, instrument-specific computer terminals/CPUs, printers to include toner for each as needed, and other equipment where required. Salient Characteristics – Reagents: The Contractor must provide all reagents/reagent packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section sufficient to maintain testing in each section. Reagents/consumables must meet the requirements of the 24/7 BAMC mission, workload, and test menu providing reagent packs containing a minimum of 500 tests and no less than 60-day open stability. Preferred system would offer a means to reduce reagent handling and inventory levels. A concentrated Reagent Delivery System is required. Should have reagent management technology, such as RFID reagent identification with on-board reagent inventory management and monitoring Reagents used for troubleshooting analytical systems must be reimbursed (or replaced) by the Contractor at no additional cost. Reagents identified as substandard by the manufacturer must be reimbursed or replaced by the Contractor at no additional cost to BAMC and Donor Center. The Contractor shall sequester lots of required test reagents, where possible, for all locations. In determining reagent requirements, the Contractor must consider requirements for routine quality control runs (as defined by the Laboratory Director), routine calibration, periodic calibration/calibration verification in accordance with departmental policy, and troubleshooting of out-of-control assays. The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any equipment, reagents, or materials. Deliveries of required items must be in monthly drop shipments or as called in by the COR or ACOR. Large items (e.g., 20 L and above), must be shipped in a split order to arrive 2 weeks apart. Orders must arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents and delivered in a timely manner, not to exceed seven (7) working days. In the instance a back- order exceeds seven (7) working days, the Contractor must provide testing services through local sub-contractor or alternate facility at their cost. Salient Characteristics - Quality Control: The Contractor must provide (3) levels of quality control materials acceptable to the section Medical Director, sufficient to perform daily testing on all testing parameters 365 days per year in each section. The Contractor shall sequester lots of required quality control materials. Open stability of quality control material must be a minimum of 7 days. QC peer group data must have real time, automatic electronic data upload capability to analyzer quality control. Must provide 24-hour, 7-days a week immediate access to internet-based QC peer review data (IQAP). Standing orders for reagents and controls to be set up in collaboration with section. Emergency orders will be delivered within 24 hours of placement. Provision for expedited shipments in contract expected. Salient Characteristics – Information Technology and Data Management System: All instruments and software will require an ATO, as they must be connected to the secure network. A data management system, to include middleware, not contained within the CBC analyzers (e.g., Data Innovations). Data management system requirements – Main Core Hematology Laboratory: The system must provide a central data management hub, to which the major systems included in this SOW connect. This must include a connection to the digital cell morphology analyzer in Core. The system must have the ability to manage critical values and delta checks. The system must have the ability to interface with slide maker/stainer to support differentiation of stat from routine smears. The system must not require remote communication to outside sources to be functional. The system must be capable of interfacing with MHS Genesis. The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors’ instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. The system must have a way to continue to process samples during LIS downtime and provide result printouts with patient demographics and appropriate age/sex specific reference intervals. The system must include at least (12) twelve remote review stations (e.g., Thin Clients) to allow access to the digital imagery system and at least (12) remote review stations for access to instrument and middleware from centralized and decentralized locations. Systems that provide the ability to control instrument software from remote locations are preferred. The middleware should include a decision logic software that can filter information from analysis and enable reflex and rerun testing, generation of manual differential smears, auto-verification, and body fluids using rule sets that have been prepared by the vendor in collaboration with sections. Pre-defined rule set must indicate International Society for Laboratory Hematology specific rules. To include Consulting Services that encompass the development and validation of auto-verification rules to include the use of delta checks, critical values, measuring ranges, and section specific rules. Army Cybersecurity/Risk Management Framework (RMF) Requirements. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data, to ensure the confidentiality, integrity, and availability of Government information. At a minimum, this shall include provisions for personnel security, electronic security and physical security. Vendors must ensure ability to conform to all standards set forth by the Department of Defense Risk Management Framework for DoD IT (DoDI 8500.01, Cybersecurity, and DoDI 8510.01, Risk Management Framework for DoD Information Technology) or to be actively pursuing within the DoD. If the latter, at minimum, a Certificate of Networthiness (CoN), indicating that the organization’s products meet or exceed the Army’s standards for security, integration and reliability, is required. New and additional requirements may be required by DHA Cybersecurity in order to attain Authority to Operate. Salient Characteristics – Pre and Post Analytics: BAMC Main Core Hematology Laboratory requires a fully automated system that includes pre-and-post analytic specimen processing with scalable, connected analytics to meet testing needs with highest efficiency with the following requirements: Pre and Post Analytic System requirements: Automated/semi-automated systems to support pre- and/or post-analytical processing of specimens (as appropriate) The instrument systems must interconnect with the major pre-analytical, analytical, and post-analytical components included in this SOW, providing for full walk-away automation (i.e., an automation/robotic line) and the ability to connect to the existing BAMC Core Laboratory Chemistry/ Immunoassay automation line in a configuration that meets the section-specific space requirements The systems must provide the vast majority of pre-analytical sample handling, transporting specimens from a start point to an appropriate instrument without manual intervention by a technician, as well as provide post-analytical computer-controlled sample archiving/storage/racking through connectivity to integrated tube sorter with archiving capabilities for post–analytic tube management Salient Characteristics - Service and Maintenance: The Contractor must meet the following service, and maintenance requirements for all testing locations at BAMC (except where specifically noted otherwise): Daily instrument maintenance should allow for system downtimes that do not exceed 20 minutes. The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair, to assist operators in correcting equipment problems. Onsite and online training required for all clinical staff at each location for each instrument system. Provide for evidence-based calibration and calibration verification methodology performance. Provide for manufacturer-assisted calibration verification onsite. Provide for minimal disruptions and waste during automation system installation. The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. This includes emergency repairs as well as routine Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment. The Contractor must provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level must be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. Completion of analyzer installation will establish time-zero for determining the time frame for performance of periodic services. Any service technician provided by the Contractor must adhere to all required reporting procedures for BAMC prior to reporting to the laboratory for work. Current procedures will be available through COR or ACOR. For equipment supporting the Core Laboratory, the service technician must be on-site to provide unlimited service within twenty-four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. Should all CBC analyzers become inoperable, the Contractor’s service technician must be on- site within four (4) hours of initial notification. The repair of at least one (1) analyzer must be completed within eight (8) hours of initial notification. If deemed necessary, after consultation with the COR, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the Contractor shall, where requested, arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory, with priority testing service provided for STAT/ASAP specimens. The Contractor shall pay all costs associated with the provision of this alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as all analyzers remain inoperable. For equipment supporting other locations, the service technician must be on-site to provide unlimited service (service requiring repair) within 24 hours establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. In all cases, the Contractor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot instrument failure. Replacement parts used, as necessary, claimed from local operator-level maintenance kits as well as any reagents that may have been used must be replaced at no cost by the Contractor. The response due date for this Sources Sought Notice is 01:00 PM CST, 29 December 2025. All questions and comments regarding this announcement shall be submitted via e-mail to medina.l.woodson.civ@health.mil and salameya.paulouskaya2.civ@health.mil