Pharmacy USP 797 & 800 Certification Testing.
Closed Pre-Solicitation Posted
- Solicitation number
- 36C26125Q0947
- Agency
-
Veterans Integrated Service Network 21
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- Service-Disabled Veteran-Owned Small Business Sole Source
Opportunity facts
- NAICS code
- 541380 Testing Laboratories and Services
- Place of performance
- Fresno, California 93703, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Network Contracting Office (NCO 21) is conducting a Sources Sought announcement to identify contractors capable of providing semi-annual certification testing for sterile compounding clean rooms at the VA Central California Healthcare System. The required services include comprehensive testing performed by Controlled Environment Testing Association (CETA) certified technicians in compliance with United States Pharmacopeia (USP) 797 & 800 standards, ISO requirements, and VHA Directives. Key contractor qualifications include maintaining at least three CETA-certified staff members, being located within a 250-mile radius of the Fresno VA facility, and having the capability to dispatch technicians on the same business day when needed. Testing must cover airflow measurements, HEPA filter integrity testing, particulate counting, differential pressure measurements, viable particle sampling, and comprehensive documentation. Interested contractors must submit capability statements to John Waldrip at john.waldrip@va.gov by 4:00 PM PST on September 12, 2025, including their socioeconomic status, company details, experience with USP 797 & 800 certification testing, and proposed approach to meeting requirements.
This opportunity is designated as a Service-Disabled Veteran-Owned Small Business (SDVOSB) sole source procurement under NAICS code 541380 (Testing Laboratories) with a small business size standard of $19 million. The contract structure includes a base year with four one-year option periods, spanning from February 1, 2026, through January 31, 2031, covering certification testing for two buildings with multiple pharmacy compounding suites. Testing must be performed semi-annually during August and February each year, with contractors required to provide preliminary digital reports within 24 hours and official final reports within 30 days of service completion. The solicitation documents indicate this is currently in the market research phase only, with no current solicitation available, and all information is preliminary and subject to modification. No incumbent contractor or specific budget range has been disclosed in the announcement, though the multi-year structure with semi-annual testing requirements suggests a substantial ongoing service commitment for sterile compounding facility compliance.
Notice text
THIS IS A SOURCES SOUGHT ANNOUNCEMENT ONLY.
No Solicitation is currently available.
All information contained in this Sources Sought Announcement is preliminary, as well as subject to modification, and is in no way binding on the Government. The Government will not pay for any information submitted in response to this request. The information requested will be used solely within the Department of Veterans Affairs to facilitate decision making and will not be disclosed outside of the Government. The determination of a procurement strategy, based upon the comments submitted in response to this Sources Sought Announcement, is solely within the discretion of the Government.
The applicable North American Industry Classification System (NAICS) Code is 541380, Testing Laboratories and the small business size standard is $19 Million.
The Department of Veterans Affairs (VA) Network Contracting Office (NCO 21) is soliciting information from contractors that can provide semi-annual certification testing to be performed by a Controlled Environment Testing Association (CETA) certified technician in compliance with United States Pharmacopeia USP<795>, USP<797>, USP<800>, ISO, and VHA Directive for sterile compounding clean rooms for the VA Central California Healthcare System. A draft copy of the Statement of Work (SOW) is attached.
Brief Description of Services
See attached Draft SOW.
Capability Statement
All interested contractors must respond by email to John Waldrip at john.waldrip@va.gov before 4:00PM. PST on September 12, 2025.
Please answer the following questions when responding:
- What is your company’s Socioeconomic Status? (ex: small business, large business, SDVOSB, etc.)
a. If SDVOSB or VOSB, are you registered with the Small Business Administration?
https://search.certifications.sba.gov/
- Provide Company’s legal name along with Unique Entity ID (SAM) number.
- Primary point of contact, including phone number and e-mail address.
- Capabilities Statement.
- Describe experience in Pharmacy USP 797 & 800 Certification Testing.
- List other Projects (Government and Commercial) that are similar in scope and size.
- As this is a service acquisition, the Small Business Administration and the Federal Acquisition Regulation have a Limitations on Subcontracting Requirements. For all small businesses, to include SDVOSB and VOSB, “At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.” See FAR 52.219-14 and FAR 52.219-27 available in full text at https://www.acquisition.gov/far/html/52_217_221.html
7a. Of the service actions listed above, which one(s) will your company perform as the prime contractor using its own personnel without subcontracting?
7b. With respect to the service actions listed above, which action(s) do you intend on subcontracting or using other than your company’s own personnel?
7c. Of those services that will be performed, approximately what percentage will be paid to the subcontractor(s)?
- GSA Contract Number, if applicable.
- Fill out the price estimate (5 Option Years) below.
*Failure to provide the information requested above (items 1-9) will be considered non-responsive and will not be considered a viable source.
RFQ number 36C26125Q0947 has been assigned and should be referenced on all correspondence regarding this announcement.
The Government will use this information when determining its business type decision.
This synopsis is not to be construed as a commitment by the Government and no contract will be awarded as a direct result of this Sources Sought announcement.
Notes: Contractors must have a current registration in the System for Award Management (SAM) at https://sam.gov/SAM/
SDVOSB and VOSB firms should be registered at the time of submission and verified at Veteran Small Business Certification (sba.gov)
CLIN
Description
Quantity
Unit
Unit Price
Total Price
0001
BASE YEAR FOR USP 797/800 TESTING AND CERTIFICATION SERVICES IN BUILDING 24.
PERIOD OF PERFORMANCE: 10/1/2025 TO 9/30/2025
1
YR
$
$
0002
BASE YEAR FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 1.
PERIOD OF PERFORMANCE: 10/1/2025 TO 9/30/2026
1
YR
$
$
1001
OPTION YEAR 1 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 24.
PERIOD OF PERFORMANCE: 10/1/2026 TO 9/30/2027
1
YR
$
$
1002
OPTION YEAR 1 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 1.
PERIOD OF PERFORMANCE: 10/1/2026 TO 9/30/2027
1
Y
$
$
2001
OPTION YEAR 2 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 24.
PERIOD OF PERFORMANCE: 10/1/2027 TO 9/30/2028
YR
$
$
2002
OPTION YEAR 2 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 1.
PERIOD OF PERFORMANCE: 10/1/2027 TO 9/30/2028
YR
$
$
3001
OPTION YEAR 3 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 24.
PERIOD OF PERFORMANCE: 10/1/2028 TO 9/30/2029
1
YR
$
$
3002
OPTION YEAR 3 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 1.
PERIOD OF PERFORMANCE: 10/1/2028 TO 9/30/2029
1
YR
$
$
4001
OPTION YEAR 4 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 24.
PERIOD OF PERFORMANCE: 10/1/2029 TO 9/30/2030
1
YR
$
$
4002
OPTION YEAR 4 FOR USP 797 TESTING AND CERTIFICATION SERVICES IN BUILDING 1.
PERIOD OF PERFORMANCE: 10/1/2029 TO 9/30/2030
1
YR
$
$
Total Estimated Price
$
Files
| File | Type | Posted |
|---|---|---|
| P09-Pharmacy USP 797 800 Certification PWS 7-11-2025.docx | DOCX document | |
| 36C26125Q0947 Sources Sought Pharmacy Certification Testing and Service.docx | DOCX document |
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