6640--CPT - Triage Meter Pro Instrument B 4 (Toledo CBOC) - Ann (Toledo CBOC) - Ann Arbor

Notice of Intent to Sole Source Requirement:

The Department of Veterans Affairs, VA Healthcare System, Network Contracting Office (NCO) 10 intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 13.106-1(b)(1)(i), Only One Responsible Source for the following items listed below. The associated NAICS code for this is 334516 Analytical Laboratory Instrument Manufacturing, with a size standard of 1,000 employees. The Product Service Code for is procurement is 6640, Laboratory Equipment and Supplies.

Description of Items:

Description

Product Number

Tests Required Annually

Triage BNP Panel 25T

98000XR

700

Triage Total 5 Controls Level 1 - 5x .25mL

88753

6

Triage Total 5 Controls Level 2 - 4x .25mL

88754

6

Triage Total Calibration Verification

88755

6

The sole source contract will be awarded to:

QuidelOrtho, 9975 Summers Ridge Road San Diego, CA 92121

A firm fixed price contract with four (4) option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 12:00PM EST, Monday, May 12, 2025, by email only.

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-25-AP-1656

Contracting Activity: Department of Veterans Affairs, VISN 10, Richard L. Roudebush Medical Center, Indianapolis, Indiana 46202, is seeking to procure a Base Plus Four Option Year contract for supply items to support the Triage Meter Pro Instrument. This contract will be to support the VA Ann Arbor Medical Center, at the Toledo Community Based Outpatient Clinic in Laboratory Services.

Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Quidel Triage MeterPro is the only known capable instrument to perform rapid BNP Test, point-of-care fluorescence immunoassay. The Triage MeterPro is used to measure B-type natriuretic peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. The Quidel Triage BNP Test is the first rapid BNP immunoassay indicated for risk stratification for both acute coronary syndrome and heart failure.

Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Per the Program Office the current method for conducting Troponin and BNP testing is performed at the Ann Arbor laboratory on an immunoassay analyzer. As of this date there is no option for onsite testing to be performed at the Toledo Community Based Outpatient Clinic. The goal was to bring forward a rapid, cost-effective testing platform that will correlate well with the immunoassay performed in Ann Arbor Laboratory. This has been accomplished and the Quidel Triage BNP equipment is already on site. Immunoassay in Toledo is not justified, as their volume is too low. Going with another vendor at this point would not only be costly but would take a great amount of time to train and get the system fully operational.

Market research completed by the Program Office determined there is only one other instrument available on market comparable to the Quidel Triage MeterPro. The similar instrument is the iSTAT, but market research concluded the iSTAT has performance issues, such as: it uses cartridges it is very easy to not deliver the specimen into these correctly, known issues with updating the analyzers, and requires external printer.

Per the Program Office the Quidel Triage MeterPro is the only instrument capable of meeting all requested functions of the requirement at this time on the market.

Description of market research conducted and results or statement why it was not conducted: Market research was conducted, beginning with VetCert, which found a potential of 234 vendors. In addition, SCMC, GSA, FPDS, eCMS, SAM Contract Opportunities, were all searched during market research, which found all requested items not available through any other vendor that can provide these supply items on a Base Plus Four Option Year Bases.

The CO was unable to locate a secondary vendor capable of meeting the requirement on such a small scale. Contracting is not in a position to suggest alternate products and therefore determined the best value to Government is to award to the manufacturer Quidel Corporation.

Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

//signed//

LouAnn Gilliland

Contracting Officer