6630--VISN 16 Lab A1C Ion-Exchange HPLC Hemoglobin A1C testing instrumentation and reagents

THIS IS A SOURCES SOUGHT (SS) NOTICE ONLY, NOT A SOLICITATION ANNOUNCEMENT AND SHOULD NOT BE CONSIDERED AS SUCH. The Government will not pay for any information received in response to this notice, nor will the Government compensate any respondent for any cost incurred in developing the information provided to the Government. This notice does not constitute a commitment by the Government. Any information provided in response to this market survey will be used for informational purpose only and will not be released. Vendor participation is not a promise of future business with the Government.

The purpose of this notice is to conduct market research and obtain information from current FSC Group 66 III Federal Supply Schedule (FSS) Contract holders under SIN 605-1a manufacturing instrumentation and reagents, providing training and performing service and repair for Ion-Exchange HPLC Hemoglobin A1C testing instrumentation and reagents under a cost per patient reportable result (CPRR) agreement at the time of this posting. Adequate information shall be provided for the Government to determine Contractors ability to provide the required instrumentation, reagents and service at the time of Contractor s response to this notice.

Network Contracting Office (NCO) 16 will be issuing a Request for Quotation (RFQ) for the South Central VA Health Care Network (SCVAHCN referred to as VISN 16) in the coming months to award a VISN wide CPRR Blanket Purchase Agreement (BPA). The BPA will include use of instrumentation, reagents, calibrators, controls, consumables, parts, contractor performed operator training, and contractor performed preventative maintenance, repair, and contractor hotline telephone troubleshooting. The BPA shall also provide connectivity through Data Innovations middleware to the VA VistA Lab Information System (LIS) and any future electronic health record LIS.

Potential sources shall submit:

Business name, address, point of contact and phone number.

Business size, any applicable socio-economic category, DUNS number and SAMS number.

Copy of Contractor s current FSS 66-III contract.

Brochures and literature detailing instrumentation and related capabilities.

Minimum Requirements:

The fully automated instrumentation shall be able to simultaneously perform the complete profile meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

Instrumentation shall be fully automated with closed primary tube aspiration.

Operating system software shall be currently sold and supported by software manufacturer

Testing Instrumentation and reagents shall be FDA approved and validated for use.

Methodology shall be ion-exchange High Performance Liquid Chromatography (HPLC).

Instrumentation shall be certified by the National Glycohemoglobin Standardization Program and traceable to Diabetes Control and Complications Trial (DCCT).

New equipment is required for each of the clinical laboratories located at the VISN facilities listed in Attachment A. Includes 7 medical center and 14 outpatient clinic laboratories.

Instrumentation shall have a current, approved VA Enterprise Risk Assessment (ERA).

Same manufacturer, methodology and reagent system for testing instrumentation across VISN 16 laboratories.

Reagents shall be liquid ready to use or require minimal to no operator preparation prior to use.

Ability to flag patient results requiring further operator review or additional testing.

Manufacturer shall have proprietary quality control material.

Ability to connect to an external printer for full page printing of results, to include demographics and the chromatogram.

A UPS with surge suppressor/line conditioner shall be provided for each instrument/piece of equipment.

All-inclusive CPRR pricing.

Basic and key operator training on testing instrumentation.

Telephone assistance center/hotline - available by telephone 24 hours per day, 7 days per week.

The above is not an all-inclusive list of technical requirements. The minimum technical requirements and technical evaluation factors will be included in the solicitation when posted. All instrumentation must be FDA approved, in current production at the time of response to this sources sought notice.

This is a sources sought notice only and is NOT the actual RFQ. The RFQ will be posted to GSA e-Buy at a later date.

All responsible sources may identify their interest to meet this requirement by responding to this notice by email to Tammie Chaney at tammie.chaney@va.gov by May 16, 2025, at 10:00 am CT. Include the following in the email subject line: VISN 16 A1C # 36C25625Q0885 . The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, and the small business size standard of 1000 Employees. Telephone requests will not be honored. No award will be made based on quotes or offers received in response to this notice.

The purpose of this notice is to assist in providing potential FSS FSC Group 66 III contractors minimally meeting the above requirements the opportunity to respond to the instrumentation available to potentially meet those requirements. Adequate information shall be provided for the Government to determine Contractors ability to provide the required instrumentation and related items at the time of Contractor s response to this notice. There is no solicitation currently available. There is no guarantee, expressed or implicit, that the market research for this acquisition will result in a particular set-aside, sole source award or any other guarantee of award strategy. All information is to be provided on a voluntary basis and at no charge to the Government.

The VISN 16 A1C Workbook contains 2 tabs. The first tab lists the address for VISN 16 laboratories. The second tab provides existing instrumentation for each lab as well as annual estimated testing volumes.