The Medical Readiness Contracting Office - West (MRCO-W) is issuing this Sources Sought Notice to find potential sources to provide a Cost-Per-Test (CPT) Agreement or Reagent Rental Agreement to include reagents, instrument/equipment, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct testing for four (4) pathogen panels: Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification for the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services - Bacteriology Laboratory, Fort Sam Houston, Texas. A base period of performance from 01 October 2025 through 30 September 2030 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):
1. Company name, CAGE code, Unique Identity ID (UEI) 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, Bacteriology Laboratory at BAMC requires the following instrument/equipment, reagents, supplies, and service:
Basic Requirements: The system must contain random access technologies that improve workflow and be approved by, and include molecular based test methods approved by, the Food and Drug Administration (FDA). The system must fit in the current space available which is approximately 5’ x 5’ per instrument.
Test Menu and Special Requirements: Listed testing requirements must be capable of completion in under 180 minutes from start time (time of loading onto instrument). All assays must be available on a single platform. Proposal should include automated, rapid, molecular based detection of all of most (>80%) of the following: Please see the information on the attachment document.
Instrument verification shall be at the expense of the Vendor, shall include materials and reagents, and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following:
1. Verification studies for each analyte. A minimum of 20 known samples per assay, shall be run by new contracted method to establish accuracy of each analyte.
2. 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.
3. 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.
4. 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.
5. 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).
6. 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:
1. Ability to manage testing workflow of hospital laboratory. Instruments must be able to perform testing for all four described testing requirements simultaneously.
2. Analyzers must be capable of running single specimens without batching requirement.
3. Integrated modules must only require one system control center (computer and screen) to simplify operations.
4. Instruments must have load on the fly capabilities for reagents, samples, bulk solutions, and consumables if required.
5. 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.
6. Vendor instrument solution must include automatic barcode reading.
7. Analyzers must either utilize single use cartridges, disposable pipette tips, OR demonstrate clinically insignificant carryover.
8. Vendor must have commonality across all analyzer platforms for the following:
a. Software
b. Reagents
c. Consumables
d. Methodology
9. Instruments must be available for full front loading of samples, reagents, consumables and bulk solutions on the fly and assay must be able to be started on demand to allow for prioritization of STAT specimens.
10. Analyzers must feature error-proof reagent and commodity design with built in safeguards to prevent reagent mix-ups and unnecessary downtime.
11. Analyzers must be capable of determining the quality of the sample and be able to detect low or insufficient volumes, aspiration issues such as bubbles, and other specimen quality issues. Please describe how analyzer detects.
12. Quality control frequency not to exceed once/24 hours/instrument platform.
13. The analyzers must have a comprehensive QC Program for all tests which includes at minimum: On-board quality control data storage and reporting capabilities and ability to view and print daily and monthly QC results.
14. Chosen analyzers must have minimal daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, including wait time, for daily, weekly, and monthly maintenance. Please include any hands on, automated non-maintenance activities.
15. 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.
16. Vendor must provide BTU output for both analytics and automation systems.
17. Meet space limitations of 5’ x 5’ per instrument. Selected design must maintain walkways and clearances around track and instruments.
18. LIS connectivity must be supported/available and should have approved use for Windows 10 or greater (more recent).
Reagents and Supplies:
1. Vendor reagents must be ready to use from storage.
2. Reagents (not including controls) would preferably be available for storage at room temperature (approximately 25°C).
3. 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. If 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.
4. Vendor must provide 5 years of FDA field action notifications.
TABLE 1. WORKLOAD DATA - Please see the included attachment.
