Inactive
Notice ID:W81K00-24-Q-0026
The Medical Regional Contracting Office, West (MRCO-W) is issuing this Sources Sought Notice for a Cost-Per-Test Arrangement for Tuberculosis Blood (QuantiFERON-TB Gold Plus (QFT-Plus) and Helicobacte...
The Medical Regional Contracting Office, West (MRCO-W) is issuing this Sources Sought Notice for a Cost-Per-Test Arrangement for Tuberculosis Blood (QuantiFERON-TB Gold Plus (QFT-Plus) and Helicobacter pylori (Stool antigen) Testing for the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services Microbiology Laboratory, Fort Sam Houston, Texas. A baseperiod of performance of twelve (12) months plus four (4) twelve (12) month option periods are contemplated. 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): 1. Company name, UEI number, 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. 2. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: Our customer, the Department of Pathology and Area Laboratory Service, Immunology and Molecular Diagnostics Department of Pathology at the main hospital located at BAMC and surrounding area clinics require the following instrumentation/equipment, reagents, supplies, calibrators, controls and materials: Basic Requirements: The system must contain random access technologies that improve workflow and be approved by, and include test methods approved by, the Food and Drug Administration (FDA). The system must fit in the current space available which is approximately 5’6” x 3’6” PER instrument. Test Menu and Special Requirements for Awarded Contractor: Vendor must meet, or improve, each Laboratory's existing turn-around times as a minimum, by any change in instrumentation. Listed testing requirements must be capable of completion in under 60 minutes from start time (time of loading onto instrument). Proposal should include automated pre-analytical specimen processing for: Tuberculosis Blood Testing (QuantiFERON-TB Gold Plus (QFT-Plus) Helicobacter pylori (Stool antigen) Method Performance/Comparison shall be at the expense of the Vendor, shall include linearity material and reagents, and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following: 1. Correlation studies for each analyte. A minimum of 20 samples, spanning the reportable range, shall be run by the present and the new contracted method. Vendor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI. 2. Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines. 3. Precision study shall be performed utilizing normal and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls. 4. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications. 5. Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances including blood container are evaluated for interfering substances for each method performed. 6. Reference Range: Determine a reference range for each test following CLSI guideline C-23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols should be used: a. If the suggested manufacturer's range is not appropriate for the patient population, a reference range must be established and may require additional reference individuals. b. If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test must be provided. 7. Analytical Measurement range validation studies must be performed by vendor for applicable analytes, 8. All technical procedures must be provided electronically by vendor in CLSI format, using software compatible with each Laboratory's computer system, for local modification (editable) to meet CAP requirements. 9. Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms. 10. Vendor must provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies). 11. Vendor must provide hands-on training to staff onsite prior to or during instrument integration at the facility. Expert/advanced user training should be offered at vendor/manufacturer site at a minimum of two (2) staff per instrument. Analytical Systems: a. Ability to manage testing workflow of hospital laboratory. Instruments must be able to perform testing for all three described testing requirements simultaneously. b. Analyzers must be capable of running short sample runs (smaller volumes) while also maintaining a minimum throughput of 100 samples per module per immunoassay. c. Vendor solution must be scalable and able to connect multiple modules together to increase efficiency and reduce space requirements in the laboratory. d. Integrated modules must only require one system control center (computer and screen) to simplify operations. e. Instruments must have load on the fly capabilities for reagents, samples, bulk solutions and consumables. Quantity of consumables and reagents must be monitored by the system software. f. Reagents must be provided in combined packaging (“ready-to-use” cartridge or packaging) for ease of loading onto instrument. Reagent packs must be able to maintain appropriate storage temperature, and the system must offer continuous monitoring of this requirement (to include lot number, usage volume, and expiration date) to aid in inventory management. g. Vendor instrument solution must provide a primary tube and aliquot sample loading capability to include automatic barcode reading. h. Analyzers must either utilize disposable pipette tips OR demonstrate clinically insignificant carryover. i. Analyzers must be able to perform “add-on” reflex testing on any previously run patient sample. j. Vendor must have commonality across all analyzer platforms for the following: a. Software b. Reagents c. Consumables d. Methodology k. Instruments must be available for full front loading of samples, reagents, consumables and bulk solutions on the fly and STATs must take priority over routine testing. l. Analyzers must have flexible STAT testing options to prioritize the most critical samples based on workflow. m. Analyzers must feature error-proof reagent and commodity design with built in safeguards to prevent reagent mix-ups, probe crashes and unnecessary downtime. n. Calibration of immunoassay analyzers must be easy and of minimal frequency. Immunoassay calibrations must only be required when QC is out of range or new lot numbers of reagent are put into use. Calibrators should be liquid and ready to use with no reconstitution or prep required prior to use. List any calibrators that require preparation and the required process. o. Analyzers must be capable of determining the quality of the sample, and be able to detect clots, low or insufficient volumes, aspiration issues such as bubbles, and other applicable liquid level sensing capabilities. Please describe how analyzer detects. p. Quality control frequency not to exceed once/24 hours/instrument platform. q. The analyzers must have a comprehensive QC Program for all tests which includes at minimum the following options: a. QC files may be edited or corrected for errors manually –. b. On-board quality control data storage and reporting capabilitiesc. c. Ability to view and print daily and monthly QC results – d. Ability to view and print Levy Jennings graphs – e. On-line documentation of out-of-range QC – f. Read barcoded QC. g. Westgard rules built in –. h. If QC fails, instrument will stop running samples – r. Chosen analyzers must have minimal daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, including washes and wait time, for daily, weekly and monthly maintenance. Please include any hands on, automated non-maintenance activities. s. Vendor to provide average number of service calls per year per analyzer, provide access to a 24/7 on-call support system, and perform preventive maintenance as required. t. Analyzer must accommodate multiple tube sizes simultaneously, to include requirements for stool antigen. u. Vendor must provide BTU output for both analytics and automation systems. v. Meet space limitations of 5’6” x 3’6” (approximate, PER instrument). Selected design must maintain walkways and clearances around track and instruments. w. LIS connectivity must be supported/available and should have approved use for Windows 10 or greater (more recent). Reagents and Supplies: 1. Vendor must provide multiple test kits sizes for immunoassays, as applicable. Please describe kit size options available for applicable tests. 2. Vendor reagents must be 99% liquid ready to use from storage, requiring no reconstitution or mixing. List all Reagents that are not liquid, ready to use. 3. Vendor calibrators must be at least 95% liquid ready to use from storage, requiring no reconstitution or mixing. List all assay calibrators that are not liquid, ready to use. 4. Quality of Reagents, Supplies and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission. In the event that the supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order. 5. Vendor must provide 5 years of FDA field action notifications.
