S02 FINAL Notification of Intent to Sole Source 36C25625Q1367.pdf
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- Solicitation number
- 36C25625Q1367
About this file
This Special Notice describes the Gulf Coast Veterans Health Care System's intent to award a sole-source, firm-fixed price contract to the College of American Pathologists (CAP) for Clinical Laboratory Improvement Act (CLIA) Laboratory Proficiency Testing Services. The contract is valued at approximately $103,500.00, with an expected award date on or before October 1st, 2025. The procurement is for comprehensive laboratory proficiency testing across over 1,100 Veterans Health Administration (VHA) laboratory locations, covering specialties including Microbiology, Bacteriology, Virology, Immunology, Chemistry, Hematology, and Cytology.
The sole-source justification is based on CAP's unique capabilities and existing support of VA laboratory testing needs, with authorization under FAR 6.302-1 for "Only One Responsible Source". The contract requires compliance with multiple federal regulations, including 42 U.S.C. 263a and 42 C.F.R. Part 493, which mandate specific proficiency testing standards for clinical laboratories. CAP is deemed the only vendor meeting all necessary requirements, with a national contract through the Strategic Acquisition Center and previous facility-level agreements. The solicitation number is 36C25625Q1367, with a response date of September 9, 2025, at 1:00 PM Eastern Time.
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Special Notice
SUBJECT* Notification of Government Intent to Sole Source, Clinical Laboratory Improvement Act (CLIA) Laboratory Proficiency Testing Services, Gulf Coast Veterans Health Care System, Pathology and Laboratory, 400 Veterans Avenue, Biloxi, MS
GENERAL INFORMATION
CONTRACTING OFFICE’S ZIP CODE* 39531
SOLICITATION NUMBER* 36C25625Q1367
RESPONSE DATE/TIME/ZONE 09-09-2025 1300 EASTERN TIME, NEW YORK,
USA
ARCHIVE 15 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS N
PRODUCT SERVICE CODE* Q301
NAICS CODE* 621511
CONTRACTING OFFICE ADDRESS Department of Veterans Affairs
Gulf Coast Veterans Health Care System Network Contracting Office (NCO) 16 400 Veterans Avenue BLDG 10 Biloxi, MS 39531
POINT OF CONTACT*
Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office (NCO) 16 ATTN: C. Robert Oravetz 400 Veterans Avenue BLDG 10 Biloxi, MS 39531
ADDITIONAL INFORMATION
AGENCY’S URL https://www.va.gov/
URL DESCRIPTION VA
AGENCY CONTACT’S EMAIL ADDRESS christopher.oravetz@va.gov EMAIL DESCRIPTION CO e-mail address
Notice Type: Special Notice
Synopsis: The Gulf Coast Veterans Health Care System (GCVHCS). Pathology and Laboratory Department, 400 Veterans Avenue, Biloxi, MS 39531 intends to award a sole-source, firm fixed price contract to College of American Pathologists (CAP), UEI: C23QW5U7MQB6, 325 Waukegan Road, Northfield, IL 60093-2750 for the following services: Clinical Laboratory Improvement Act (CLIA) Laboratory Proficiency Testing Services. The authority for this action is FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The total estimated cost of the proposed contract is approximately $103,500.00. The North American Industry Classification System (NAICS) code is 621511-Medical Pathology Laboratories with a size standard of $41.5 million. The expected award date for this contract is on or before October 1st, 2025.
Clinical Laboratory Improvement Act (CLIA) Laboratory Proficiency Testing Services are unique, complex, highly specialized, and are from a niche market. The Veterans Health Administration (VHA) laboratory community comprises over 1,100 laboratory locations which require laboratory proficiency testing in some or more of the following areas/specialties: Microbiology, Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology, Diagnostic Immunology, Syphilis Serology, General Immunology, Chemistry, Routine Chemistry, Endocrinology, Toxicology, Hematology & Coagulation, Immunohematology, and Cytology. For these laboratory facilities to function/operate in support of the delivery of veteran patient care each individual site must have an established laboratory proficiency testing program in place which includes total compliance with the following while this program is in operation:
42 U.S.C. 263a Certification of laboratories (also known as Clinical Laboratory Improvement Amendments of 1988 (CLIA)) mandates Proficiency Testing be performed for Clinical Laboratories.
42 C.F.R. Part 493 Subpart H Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing mandates the use of Centers for Medicare and Medicaid Services (CMS) approved proficiency testing provider.
38 C.F.R. 17.3500 -- VA application of 42 CFR part 493 standards for clinical laboratory operations gives VA the authority to oversee the proficiency testing program for VHA laboratories.
42 C.F.R. Part 493 Subpart I Proficiency Testing Programs for Nonwaived Testing, mandates regulated analytes proficiency testing that laboratories must participate.
VHA Directive 1106 Pathology and Laboratory Medicine Service mandates nonregulated analytes proficiency testing that laboratories must also participate
On a national and local level College of American Pathologists (CAP) has been supporting the Department of Veterans Affairs with these services. Under definitive contract 36C10G25C0001, executed by the Strategic Acquisition Center (SAC), laboratory facilities across the Veterans Health Administration are being supported with a majority of their laboratory proficiency testing needs from this agreement. For unique proficiency testing requirements that are unique to the facility (and not specifically or totally covered under this national contract) small local agreements are executed in order to augment this national agreement (in support of local facility needs).
College of American Pathologists (CAP) has supported (and is currently supporting) the facility and the Department of Veterans Affairs with laboratory proficiency testing services. To be qualified to execute these exclusive services contractors must possess specific competencies and have intrinsic knowledge about the policies, directives, and regulations which govern the rendering of these services. College of American Pathologists (CAP) meets all necessary requirements and is an approved vendor having been awarded a national contract through the Strategic Acquisition Center (SAC) and previous agreements at the facility level for performance of these services. Due to the specific nature of these services competition is already restricted per 42 C.F.R. Part 493 Subpart H which requires that potential vendors be approved as authorized providers who are eligible to participate in the Proficiency Testing Program for CLIA (Clinical Laboratory Improvement Act). While College of American Pathologists (CAP) meets these (and other mandatory requirements) to perform these services other contractors (in any socioeconomic category) do not meet all of these requirements.
This notice is not a request for Expressions of Interest (EOI), offers, proposals, quotations, or bids, and no solicitation will be issued.
Contracting Office Address:
Gulf Coast Veterans Health Care System 400 Veterans Avenue BLDG 10 c/o Engineering Service Biloxi, MS 39531 United States
Place of Performance:
Gulf Coast Veterans Health Care System (GCVHCS) Pathology and Laboratory Service 400 Veterans Avenue Biloxi, MS 39531 United States
Point of Contact:
C. Robert Oravetz Contracting Officer christopher.oravetz@va.gov mailto:christopher.oravetz@va.gov
| 36C25625Q1367 |
| Special Notice Sole Source Clinical Laboratory Improvement Act Laboratory Proficiency Testing Services |
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