Q301 Cleveland Reference Laboratory Testing

THIS IS NOT A SOLICITATION, THIS IS A SOURCES SOUGHT NOTICE ONLY and is issued in accordance with Federal Acquisition Regulation (FAR) 10 Market Research, to conduct market research. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. This Sources Sought Notice is issued solely for information and planning purposes and does not constitute a solicitation or guarantee to issue a solicitation in the future. This Sources Sought Notice does not commit the Government to contract for any supply or service. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Not responding to this Sources Sought Notice does not preclude participation in any future solicitation, if issued. This announcement is based on the best information available at this time and is subject to future modification.

Purpose and Objectives

The Department of Veterans Affairs, Louis Stokes Cleveland VA Medical Center (VAMC), 10701 East Blvd., Cleveland, OH 44106 requires a contractor to provide reference laboratory testing services in accordance with the Performance Work Statement (PWS) and test list for a board range of tests for esoteric testing on clinical and anatomical specimens for disease, diagnosis, treatment monitoring, and in general support of clinicians to provide essential patient care. The Government intends to award an Indefinite Quantity Indefinite Delivery (IDIQ) contract with a base year, and four one-year option periods to be exercised at the Government's discretion.

This Sources Sought Notice is being issued by the Veterans Health Administration (VHA), Network Contracting Office (NCO) 10 located in Indianapolis, IN as part of market research for planning purposes.

A draft a copy of the PWS and required test list with estimated quantities are attached and is the only information available at this time.

The applicable NAICS Code is 621511 Medical Laboratories

Size Standard - $41.5 Million

Product Service Code is Q301 Medical Reference Laboratory Testing

Responses:

Please submit your response in accordance with the following instructions:

Responses are due by 6/25/2025 at 3:00 PM EST.

1. Responses shall be submitted via email to Thomas.Bellamy@va.gov.
   1. Subject line of the email shall include this Sources Sought Notice Number Cleveland Reference Laboratory Testing Firm Name
   2. Complete sections C-K and sign acknowledgement statement
   3. Submit this document with any relevant attachments
2. Contractor Point of Contact to include:
   1. Name:
   2. Title:
   3. Phone:
   4. Email:
3. Company Information to include:
   1. Name:
   2. Address:
   3. UEI:
   4. CAGE Code:
   5. Tax ID Number:
   6. Business Size:
4. Business Size/Type: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), 8(a), Hub Zone Small Business, Women Owned Small Business (WOSB), Small Disadvantaged Business (SDB), Small Business, or Large Business.
   1. All prospective Contractors are reminded that in accordance with FAR 4.11 they shall be registered in the System for Award Management (SAM) database and shall complete annual Representations and Certifications in SAM prior to any offer. SAM is located at http://www.sam.gov and consolidated the capabilities of CCR/FedReg, ORCA, and EPLS. There is no cost to use SAM.
   2. FOR SDVOSB/VOSB ONLY: Please note that if responding as an SDVOSB or VOSB, your company must be registered and certified in the VetCert database, which is available at: Veteran Small Business Certification (sba.gov)
   3. Please include a copy of your VetCert Certification with your response.
5. Contractors Federal Supply Schedule Contract that carries the desired services.
   1. If you do not have a Federal Supply Schedule contract, you shall state open market :
   2. Provide the Schedule:
   3. Provide your GSA/FSS/SAC Contract Number:
   4. Provide the SIN(s) for reference laboratory testing:
   5. If any of the items are not on your GSA/FSS contract you will mark which items are open market.
6. Contractor shall provide (3) past contracts for the same or similar services:

Include:

Name of Company:

Company POC:

Company POC phone:

Company POC email:

Dollar amount of contract:

Contract number:

Period of Performance:

Contractor shall respond to the following questions as part of the requirements in the PWS:

Y / N (check yes or no)

1. Are you able to comply with all the requirements listed in the PWS section C(a)?
2. Is your laboratory fully licensed/accredited and actively engaged in providing the specific services and laboratory testing outlined in the PWS section C(b)?
3. Is your laboratory licensed/ accredited by the College of American Pathologists (CAP), The Joint Commission (JTC), or any other licensing and/or accreditation as required by law in order to perform the required testing listed in the PWS?
4. Is your laboratory certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988?
5. Is your Laboratory Director an American Board of Pathology, certified Pathologist or American Board of Bioanalysis, certified Bio-analyst?
6. Do you have at least three years of experience providing laboratory services and at least one year experience in transporting biomedical materials?
7. Do you have all the CLIA certifications for the analyte specialties and sub-specialties listed in the PWS section C(b)(ii)(3)(a)?
8. Are you able to comply with the quality review requirements in the PWS section C(h)?
9. Are you able to provide on-site processing staff in accordance with the PWS section C(j)?
10. Are you able to provide the equipment, data management system, security, and connectivity requirements in accordance with the PWS section C(k)?
11. If awarded a future contract, do you plan to utilize a Sub-Contractor? If so, please provide the following information.
12. Company Name:
13. Address:
14. POC Email:
15. DUNs Number:
16. Business Size:
17. Describe work to be completed by the Sub-Contractor:
18. Describe work to be completed by Contractor:
19. Does the Sub-Contractor have all the appropriate licensure and accreditation mentioned above?

i) Contractor shall provide CLIA certificate of accreditation listing analyte specialties and sub-specialties listed in the PWS section C(b)(ii)(3)(a) for itself and for its Sub-Contractor.

j) Contractor shall provide a letter from the Sub-Contractor that demonstrates that the Sub-Contractor agrees to perform all tests not performed by the Contractor, to include those tests that the Contractor is not certified to provide itself.

k) Contractor shall include any relevant comments for any attachments, if applicable.

DISCLAIMER

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with 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 associated with responding to this RFI.

Background
The Department of Veterans Affairs, specifically the Louis Stokes Cleveland VA Medical Center (VAMC), is seeking a contractor to provide reference laboratory testing services. This initiative aims to support clinicians in delivering essential patient care through comprehensive testing for disease diagnosis, treatment monitoring, and other clinical needs.

The Veterans Health Administration (VHA), Network Contracting Office (NCO) 10 in Indianapolis, IN, is conducting this market research as part of its planning process. The contract will be structured as an Indefinite Quantity Indefinite Delivery (IDIQ) with a base year and four optional years.

Work Details
The contractor will be responsible for providing a wide range of esoteric laboratory tests on clinical and anatomical specimens. Key tasks include:
- Compliance with the Performance Work Statement (PWS) requirements.
- Provision of testing services that meet quality standards outlined in the PWS.
- Timely processing and reporting of test results to ensure effective patient care.
- Maintenance of laboratory accreditation and compliance with health regulations.
- Implementation of secure data management systems for handling patient information in accordance with HIPAA regulations.
- Coordination with VA staff for specimen collection, handling, and transportation.
- Regular communication with VAMC representatives regarding service delivery and quality assurance.

Place of Performance
Services will primarily be performed at the Louis Stokes Cleveland VA Medical Center located at 10701 East Blvd., Cleveland, OH 44106.