Draft Statement of Work.docx

SOW –Incubation & Analysis – VA Northern California Health Care System Incubation, Processing, Analyzing, and Reporting of Gloved Fingertip and Thumb Samples, Media Fill Test, Viable Active Air Samples, and Viable Surface Samples

Draft Performance Work Statement

1. SCOPE: The Contractor shall incubate, process, and analyze Gloved Fingertip and Thumb (GFT) Samples, Media-fill Test (MFT) Samples, Viable Active Air Sample, and Viable Surface Samples according to 2023 USP <797> standards. The Contractor shall also report results and details about the incubation process including the requirements outlined in the 2023 USP <797>. The media/plates/paddles will be provided by VANCHCS in coordination with the Contractor. The samples will be collected by qualified staff of the VANCHCS and will be shipped to the Contractor at the cost of the VANCHCS.

2. CONTRACT PERIOD: The contract period shall be one-year beginning __________________. The contract will also contain a provision for four fiscal-year renewals.

3. SERVICES TO BE PROVIDED:

· Gloved fingertip and thumb (GFT) sample incubation and sample analysis.

· Media-fill testing (MFT) sample incubation and sample analysis.

· Bacteria and fungi surface sample incubation and sample analysis.

· Bacteria and fungi active air sample incubation and sample analysis.

· Microbial identification to at least the genus level of viable surface samples and viable active air samples exceeding the cfu limits listed in 2023 USP <797>.

The Contractor shall incubate and process personnel related assessment GFT samples according to 2023 USP <797> standards. GFT results will be reported for each plate/paddle, with the amount of colony forming units (cfu) present on each plate reported. No growth present shall be indicated on the report as < 1 cfu.

The Contractor shall incubate and process personnel related assessment MFT samples according to 2023 USP <797> standards. MFT results will be reported as negative (pass) or positive (fail); failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container–closure unit(s) on or before 14 days.

The Contractor shall incubate and process viable surface samples according to 2023 USP <797> standards. Surface sample results will be reported in number of cfu. If cfu measured during viable sampling exceed USP <797> threshold levels, the report will at a minimum identify genus and, when possible, species of any microorganism recovered SOW –Incubation & Analysis – VA Northern California Health Care System on the report. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu. All samples will be processed as single media dual incubation.

The Contractor shall incubate and process viable active air samples according to 2023 USP <797> standards. Active air sample results will be reported in number of cfu. If cfu measured during viable sampling exceed USP <797> threshold levels, the report will at a minimum identify genus and, when possible, species of any microorganism recovered on the report. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu. All samples will be processed as single media dual incubation.

The Contractor shall report the incubation dates, time period, and incubation temperature for each sample. The report shall also contain the condition of the sample at receipt, the type of media, the Lot number, and the expiration date.

4. TERMS AND CONDITIONS:

Qualifications:

The contractor will provide proof of ISO 17025 accreditation.

Exclusions:

Service does not include the media/paddles/plates, the collection, and the shipping of the samples.

Information Security: The contractor will not access any computer system or protected health information at the VA Northern California Health Care System. The C&A requirements do not apply, and a Security Accreditation Package is not required.