H165--cap linearity survey

THIS REQUEST FOR INFORMATION (RFI)/ SOURCES SOUGHT IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION.

NOTICE

This RFI does not constitute a Request for Quotation (RFQ) or a promise to issue an RFQ in the future. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI. It is the responsibility of the responders to monitor this site for additional information pertaining to this requirement. Responses or questions concerning the composition and requirements to the RFI will not be returned.

All capable contractors are welcome to respond to this notice and shall provide a brief capability statement that covers the information in the performance work statement. The Capability Statement shall be limited to 10 pages and no more than 5MB. The Government will not review any other information or attachments included, that are more than the 10-page limit. The Government will not review generic marketing materials that do not address the information contained herein or the attached documents.

GENERAL

Your response must address capabilities specific to the services required in the performance work statement and must include the following:

Request Company information to include:

Company Name

SAM CAGE/ Unique Entity ID under which the company is registered in Sam.gov/VetBiz.gov

Company Address

Point of contact name

Telephone number

Email address

Socioeconomic data

Company Business Size Status and representations of your business

General pricing of your products/solution. Pricing will be used for the purpose of market research only.

Names and types of current federal contracts and/or contract vehicles that can be utilized for the scope of the requirements.

This is not a request for quotes or proposals. Department of Veterans Affairs anticipates the award of a one year Firm Fixed Price contract. Contract to begin date is on March 1, 2025. The NAICS code is 541380.

All interested parties shall respond no later than 1/08/2025 3:00PM EST. Submit responses to via email to charles.willis@va.gov. Telephone responses will not be accepted.

STATEMENT OF WORK

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:

ensure reliability of patient testing in the laboratory, and

meet accreditation requirements

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.

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 is available.

Continuing Education Programs: As an continuing education requirement, pathologist are required to obtain 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

The calibration verification and linearity program should provide specimen kits for all tests.

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

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