H966--MFT&GFT Testing and Incubation Services

Statement of Work (SOW)

To procure Pharmacy Gloved Fingertip Testing and Media-Fill Testing (GFT – MFT) services for the VA Sierra Nevada Healthcare System (VASNHCS) Pharmacy, ensuring compliance with Environmental Microbiology Lab Accreditation Program (EMLAP) standards and USP <797>.

• Sampling Supplies and Preparation: Contractor to supply sampling kits and all materials necessary for sample preservation and transport, adhering to USP <797> standards. Contractor must provide special forms and handling procedures for chain-of-custody.

• Laboratory Services: An ISO/IEC 17025:2017 accredited laboratory will process microbiological surface samples, Gloved Fingertip and Thumb (GFT) samples, and Media-Fill Testing (MFT) samples. This includes incubation, analysis, recording, and reporting of results according to ISO/IEC 17025:2017 and 2023 USP <797>.

• Testing Procedures: Specific incubation temperatures and durations for GFT, MFT, and surface samples are detailed, along with reporting requirements for colony-forming units (cfu), microbial identification (to genus and species level if exceeding thresholds), and pass/fail results for MFT.

• Shipping: Collaboration with VA Medical facility Pharmacy Service for sample shipping. Contractor to report sample receipt within two days.

• GFT Testing: Action levels defined in USP <797> Table 1. Failure notification required within 1 business day for action level exceedances.

• MFT Testing: Failure indicated by visible turbidity or growth within 14 days. Failure notification required within 1 business day.

• Surface Sampling: Action levels defined in USP <797> Table 8. Failure notification required within 1 business day.

• Reporting: Final reports due within 3 business days of testing completion, including sample details, incubation parameters, and condition upon receipt. Urgent notifications for failures required within 1 business day.

• Base Year: March 26, 2026 – March 25, 2027

• Option Years: Four additional option years through March 25, 2031

• Place of Performance: Services to be performed by an ISO/IEC 17025:2017 accredited laboratory; samples submitted by VA Medical Centers in VISN 21.

• Non-personal services contract.

• Contractor must be ISO/IEC 17025:2017 accredited under EMLAP and shall not outsource services.

• Contractor personnel performing analysis must be licensed and qualified environmental microbiologists or technicians.

• Court testimony may be required from testing personnel at no additional expense to the Government.

• All data and documentation are property of the U.S. Government and subject to Federal records management obligations.

Sources Sought Notice

This is a Sources Sought Notice for market research regarding MFT and GFT Testing and Incubation Services at the VA Sierra Nevada Healthcare System. The government is seeking information to make acquisition decisions and is not soliciting proposals or quotes at this time. No costs incurred in responding will be reimbursed.

• Non-Personal Services Contract for Environmental Microbiology Lab services.

• Services include processing, incubating, analyzing, recording, and reporting results for microbiological surface samples, Gloved Fingertip and Thumb (GFT) samples, and Media Fill Testing (MFT).

• Sample plates will be provided by the contractor.

• Samples will be collected and submitted by VA Sierra Nevada Health Care System (VASNHCS) in Reno, Nevada.

• Processing must comply with International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 and 2023 United States Pharmacopeia (USP) <797> standards.

• This requirement is to meet new USP<797> standards.

• Period of Performance: March 26, 2026 – March 25, 2031 (Base Year + 4 Option Years).

Interested vendors are requested to provide the following:

1. Company Name, Point Contact, Email address
2. An Informal Quote
3. Authorized Distributor Letter (if applicable)
4. Capabilities Statement /Narrative
5. NAICS code and size standard
6. UEI Number
7. Vendor POC information
8. Information on existing contracts (GSA, NASA SEWP, DLA eCAT, VA SAC, VA NAC) for these items. Failure to provide items 1-8 will be considered nonresponsive.

Not specified in this notice.

• NAICS Code: 541380 (Testing Laboratories and Services)
• Product Service Code (PSC): H966 (Other Quality Control, Testing, and Inspection- Instruments and Laboratory Equipment)
• Point of Contact: John Waldrip (john.waldrip@va.gov, 702-791-9000)
• A draft Statement of Work (SOW) is attached.