S02 NOISS 36C24526Q0189.docx

Special Notice Special Notice

GENERAL INFORMATION

VAMC (688)

50 Irving Street NW Washington DC 20422

POINT OF CONTACT*

Contract Specialist Naana Owusu-Ansah naana.owusu-ansah@va.gov

ADDITIONAL INFORMATION

DESCRIPTION

Department of Veterans Affairs (VA), Network Contracting Office 5, is issuing this Notice of Intent to Sole Source in order to identify any potential sources that have the resources and capabilities to provide the services described in the Statement of Work below.

The government is contemplating a one-year, Firm Fixed Price contract to satisfy this requirement and meet the needs of Washington DC VA Medical Center.

INTERESTED & CAPABLE RESPONSES

NCO 5 is seeking responses from businesses that are interested in this procurement and consider themselves to have the resources, rights, and capabilities necessary to provide these services.

Please respond with your:

· Business name

· Business type

· Socio-economic status (e.g., Veteran-Owned, Woman-Owned, Disadvantaged Small Business, 8(a), etc.)

· Point of contact (including name, telephone number & email address)

· GSA Contract number if applicable

· SAM UEI number

· Capability statement

· Authorized Distributor Letter

Responses must be submitted by 3:00 PM (EDT) Wednesday, December 24, 2025. Responses to the information requested above may be submitted via email to naana.owusu-ansah@va.gov. No telephone calls will be accepted.

DISCLAIMERS

This Notice of Intent to Sole Source does not constitute a solicitation. All information received in response to this notice that is marked proprietary will be handled accordingly in accordance with (IAW) Federal Acquisition Regulation (FAR) 15.201(e). Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses incurred associated with responding to this RFI.

This Special Notice of Intent to Sole Source is for planning purposes ONLY. The results of this notice will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., small business set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice.

STATEMENT OF WORK

A. Background

All Department of Veterans Affairs (VA)’s Pathology and Laboratory Medicine Service laboratories that perform testing on patients must meet the Clinical Laboratory Improvement Act 1988 and amendments (CLIA)1988 requirements to:

a) ensure reliability of patient testing in the laboratory, and

b) meet accreditation requirements

1. Both the regulations in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and all laboratory accreditation agencies require clinical laboratories to verify performance characteristics of quantitative test systems. Laboratories must verify performance claims when introducing an unmodified, US Food and Drug Administration–cleared or approved test system, and they must comply with requirements for periodic calibration and calibration verification for existing test systems. They must also periodically verify the analytical measurement range of many quantitative test systems.

2. External linearity and calibration verification program: As an enhancement to the internal Quality Control Program, to ensure reliability of patient testing in the laboratory, and to maintain accreditation requirements, the laboratory must subscribe to an external linearity and calibration program that meets CLIA’88 requirements for all analytes for which linearity and calibration verifications are available.

3. Continuing Education Programs: As a continuing education requirement, pathologists are required to obtain and maintain continuing medical education hours per year.

B. Scope The overall purpose of this requirement is to obtain a contractor to provide a linearity and calibration verification program for the Washington DC VA Medical Center’s Pathology and Laboratory Medicine Service to meet its accreditation requirements. This contractor must also be able to provide continuing education programs to meet the required medication education hours for Pathologist.

C. Requirements

1. The calibration verification and linearity program should provide specimen kits for all tests listed in Appendix A.

2. The contractor to provide an established event calendar and/or shipping table that identifies the dates of each shipment.

3. The contractor to provide a formal evaluation report for all tests submitted.

D. Delivery Location 50 Irving ST NW Washington DC, 20422

APPENDIX A

Special Notice