CMHS - Roche Chemistry Analyzer Tests BPA Notice of Intent

Notice of Intent to Limit Sources  

This is a special notice prepared in accordance with Federal Acquisition Regulation (FAR) subpart 5.2 - Synopses of Proposed Contract Actions.  The 10th Contracting Squadron, Operational Contracting Office, United States Air Force Academy (USAFA) Colorado, intends to award a Firm-Fixed Price single source award to Roche Diagnostics Corporation, a large business headquartered at 9115 Hague RD Indianapolis, Indiana 46256-1025, United States. This acquisition is for a Blanket Purchase Agreement that supplies blood tests and reagents for a Chemistry Analyzer and will be awarded off of Veterans Affairs (VA) Federal Supply Schedule (FSS) V797P-7347A. This procurement is for the acquisition of commercial items using simplified procedures in accordance with (IAW) FAR parts 8 and 12. The authorities for this noncompetitive award are FAR 8.405-6(a)(1)(i)(B) and (C), only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized and in the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures.

The North American Industrial Classification System (NAICS) code for this acquisition is 334516 and the business size standard is 1,000 employees. This synopsis is for informational purposes only and does not constitute a solicitation for bids or proposals. DO NOT submit a bid/quote at this time. The anticipated award date is unknown.  The Chemistry Analyzer, tests, and reagents shall meet the following capabilities:

- Anticipated Period of Performance: 1 Jul 2025 to 30 Jun 2026.

- Roche chemistry analyzers capable of performing on-board standard chemistry and/or immunoassay chemistry, either as separate standalone units or integrated units. Each Roche analyzer must be adapted for and must meet the specific cost per reportable result (CPRR) testing workload and workflow for the 10th Medical Group (10 MDG) at USAFA, the 21st Medical Group (21 MDG) at Peterson Space Force Base, and Evans Army Community Hospital (EACH) on Ft. Carson. They must include basic training and technical support services for equipment and operating systems.

- The Roche analyzers shall be capable of performing testing with minimal to no manual preparation of samples by technicians and shall perform automated dilutions (reagents) from original sample tubes. Automatic repeat and reflex testing from original sample tube is required. The Roche analyzers must be capable of bar code reading and sample level sensing, to include clot detection. Analyzers will accommodate a variety of sample tubes to include primary collection tubes and micro sample tubes. Systems will utilize random access sampling to allow for STAT (60 minutes maximum turnaround) or ASAP (120 minutes maximum turnaround) sample loading. 

- The Roche analyzers must not require any uncommon power, waste or water requirements. Roche analyzers operating system must include the capability to track and store, at a minimum, 90 days of calibration, quality control (QC) and patient result data and provide for visual display of graphs and curves for QC data. The operating system shall interface with the laboratory information system (LIS) via RS 232C bidirectional interface and accommodate ASCII query capability to process specimen identification, work orders from the LIS. This interface should also accommodate HL7 interface when the LIS conducts upgrades. Note: the LIS is not a network connection, it refers to the information residing in the chemistry analyzer and produces reports related to the devices use, calibration, maintenance data, number of test etc.

The College of American Pathologists (CAP) in conjunction with the U.S. Food and Drug Administration (FDA), mandate that all medical treatment facilities are accredited and remain in compliance with standards to operate. To maintain this accreditation, each medical treatment device must perform "Test Method Validation and Verification - Nonwaived Tests." Prior to clinical use of each unmodified FDA-cleared or approved test, the laboratory must perform a verification study and prepare a written assessment of specific method performance specifications, as applicable, using a sufficient number of characterized samples. Examples of the verification/validation testing standards include:

1. Analytical accuracy
2. Analytical precision
3. Analytical sensitivity
4. Analytical specificity
5. Reportable range

Each medical device has a different amount of time needed to fully execute all validation/verification standards needed to pass. The chemistry analyzers require a period of approximately 6 months to run all tests. The incumbent chemistry analyzer and the successor chemistry analyzer for a future BPA need to run concurrently to execute these tests. If a new BPA was awarded to a different vendor, there would be a break in chemistry analyzer tests at 10 MDG, 21 MDG, and EACH for approximately 6 months. Patients rely on these tests and are essential to giving the standard of care required to Tricare beneficiaries.

THIS NOTICE OF INTENT IS NOT A SOLICITATION, REQUEST FOR PROPOSAL OR A REQUEST FOR QUOTATION. A solicitation package will not be issued. Requests for copies of a solicitation in response to this notice will not be honored or acknowledged. Information received in response to this notice will be considered solely for the purpose of determining whether conducting a competitive procurement in the future is in the best interest of the Government. All information submitted should support the vendor's capability to provide the supplies required and shall be furnished at no cost or obligation to the Government.  Responses must be in writing and must provide clear and concise documentation indicating any vendor's capability to provide these supplies. All communication must include Notice ID:  CMHSRoche2025NOI. Verbal responses are not acceptable and will not be considered. Responses and questions shall be received via email by kenneth.jackson.30@us.af.mil NLT 17 Apr 2025 at 1400 MDT.