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Sources Sought Notice – Cost-Per-Reportable Result Coagulation Reagents for Analyzer The Regional Health Contracting Office - Central is issuing this Sources Sought Notice on behalf of San Antonio Mil... Sources Sought Notice – Cost-Per-Reportable Result Coagulation Reagents for Analyzer The Regional Health Contracting Office - Central is issuing this Sources Sought Notice on behalf of San Antonio Military Medical Center, JBSA - Fort Sam Houston, Texas. Any responses to this Sources Sought Notice will be used for planning purposes only. This notice is not a solicitation of binding offers, nor is it a notice to proceed. The San Antonio Military Medical Center (SAMMC) has a requirement for a Cost-Per-Reportable Agreement (CPRR) to include reagents instrument/equipment, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct coagulation testing to include: PT, PTT, Fibrinogen, D-Dimer and Anti-Xa testing for the Hematology Core laboratory Department at Brooke Army Medical Center (BAMC), Fort Sam Houston TX for FY23 through FY27. The Coagulation testing is performed to determine if the patient has a clotting disorder. The tests measure the number of proteins and how each protein is functioning. Clinicians frequently order coagulation tests such as the prothrombin time (PT) and activated partial thromboplastin time (aPTT) to assess blood clotting function in patients. Fibrinogen Level tests how much of the protein called fibrinogen is in the blood. Placental abruption, fibrinolysis, or hemorrhages can be detected with this test. D-Dimer test is used to determine if there is a blood clotting condition such as deep vein thrombosis, disseminated intravascular coagulation (DIC), pulmonary embolism or stroke. Anti-Xa assays are used to monitor Heparin therapy in order to achieve a therapeutic target. Vendors that consider themselves capable of providing the required testing are invited to submit a capability statement for the Government to consider via email to the Point of Contact listed herein. This capability statement shall include the following information. If the capability statement does not address ALL of the points below, the vendor will not be considered as capable of providing the required testing: Vendor name (to include CAGE code and DUNS number); Point of Contact (to include email address and phone number); business size. Documentation that demonstrates its ability to provide and conduct coagulation testing to include: PT, PTT, Fibrinogen, D-Dimer and Anti-Xa Reagents. Food and Drug Administration (FDA) approval if applicable. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: Basic Requirements: The system must contain random access technologies that improve workflow. The system must be scalable on site to accommodate anticipated increases in workload and to acquire improved technology. The system must fit in the current space available. The analyzer and its components to include the workstation should not exceed the following dimensions for the primary floor size analyzers that will be in the main Core lab (6 ft. wide, 4.5 feet deep, 4’3’’ ft. high). For the table top analyzer going in the Emergency Department lab the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5 ft. long, 2.5 ft. deep, and 2’3 high). Coagulation Instrumentation: Individual analyzers must have fully automated, discrete random access capabilities. There must be a procedure to allow priority analysis of STAT specimens. Each analyzer must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes after loss of power. Further, electrical line conditioners must be provided to support each analyzer if determined necessary upon evaluation of the local facilities. The primary computer for each coagulation analyzer must be supplied with a printer. Damaged or worn printers must be maintained and/or replaced by the Contractor at no additional cost to the Government with the exception where damage was caused by willful acts or negligence on the part of the Government. Toner or ink cartridges (as appropriate) must be provided for each printer to maintain operations thorough the contract at no additional cost to the Government. Analyzer must have a display with touchscreen capabilities as well as an audible alarm for issues with the analyzer or sample. A data management system, to include middleware, unless similar capability can be supported within the analyzer systems. Middleware must be capable of monitoring QC. Capability to repeat testing on samples deemed necessary by rules written in middleware. The analyzers will have an interface that is compatible to the government system MHS Genesis and will be able to recognize MHS Genesis generated bar-code labels on primary sample tubes. Pedestal (floor stand) capable of supporting each coagulation analyzer system (as appropriate), computer terminal or other automated instrument/peripheral as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance). Each analyzer must be capable of handling multiple tube sizes, with the most common being 13 x 75mm standard or Hemaguard (or equivalent) test tubes, to include pediatrics and microcontainers. Positive barcode identification for samples. Positive barcode identification of reagents. Management of reagents to include name, lot number, volume, stability and expiration date: The system must continually monitor volumes and expiration for all on-board reagents, providing a warning and testing lockout for reagents that are expired The analyzer must have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1. Comprehensive QC program: Each analyzer will come equipped to perform continuous, random statistical analysis capable of internal, real-time statistical Quality Control (QC). Each analyzer must include comprehensive, fully integrated QC program that uses common statistical control rules (e.g., Westgard Rules). In addition, the QC program must be able to present data in a graphical format useful to detect shifts and/or trends in the QC system (e.g., Levy-Jennings charts). The system must be able to participate in additional QC assessments using peer-group comparisons available on at least a monthly basis, with statistical comparisons including the mean, standard deviation and % coefficient of variation by QC lot number at a minimum. Traceability of patients results Cap piercing option. The analyzer must provide results for PT, aPTT, Fibrinogen, D-Dimer and Anti-Xa within 15 minutes of sample introduction to the system. The system must provide a minimum test throughput of at least 150 tests per hour for PT and aPTT respectively. Each system must have a maximum sample size less than 200 µL in all modes with a maximum dead volume of 250 µL. The systems must provide the capability to perform reflex testing without the need to retrieve/replace specimens on the analyzer. The system must provide basic clot-detection capability. Analyzer routine manual maintenance will be minimized; no manual maintenance is preferred. The PTT reagent must be appropriately sensitive and responsive to Heparin. Each analyzer must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytical measurement range. Analyzer initial startup from the shutdown state must not exceed 30 minutes. Each analyzer and all associated reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time. The D-Dimer assay must be FDA approved for the exclusion Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). The system must be open, allowing use of 3rd party vendor reagents. Reagents used for troubleshooting analytical systems must be reimbursed (or replaced) by the contractor at no additional cost. The Contractor shall be able to sequester lots of required quality control materials and test reagents where possible. The Contractor will provide a Technical Support Specialist on site to perform lot conversions. The Technical Support Specialist will run the test collect data, perform data analysis and provide electronic data presentation. The Technical Support Specialist will be also be on site at the hospital to perform method validation studies for all analyzers to include Core lab primary and backup analyzer and the Emergency Department laboratory analyzers. All supplies and reagents necessary for these studies will be provided by the contractor at no additional cost to the Government. The analyzer and its components to include the workstation should not exceed the following dimensions for the primary floor size analyzers that will be in the main Core lab (6 ft wide, 4.5 feet deep, 4’3’’ ft high). For the table top analyzer going in the Emergency Department lab the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5 ft long, 2.5 ft deep 2’3’’high). All computer systems connecting to the network and MHS Genesis must be RMF compliant, have an authority to operate (ATO) and be Health Insurance Portability and Accountability Act (HIPAA) compliant. Government requires delivery of the analyzer/ instrumentation within 30 days and correlated, validated and connected to the DHA system before or on 1 October 2022 Please see attachment with the mandatory tests.