Draft Performance Work Statement Viable Surface Sampling VA Central California FY27

PERFORMANCE WORK STATEMENT

Monthly Viable Surface Sampling

PURPOSE:

The contractor shall provide all labor, supplies, equipment, information technology, transportation, and supervision necessary to conduct a clean room monthly surface viable sampling of pharmacy sterile compounding suites in Building 1 and Building 24. This testing is to detect any microbial contamination and provide information on the environmental quality of the sterile compounding areas. The testing will help with the certification to ensure compliance with USP <797>, USP <800>, and Joint Commission standards for sterile compounding clean rooms.

PLACE OF PERFORMANCE:

VA Central California Healthcare System (VACCHCS), 2615 E. Clinton Ave, Buildings 1 & 24, Fresno, CA 93703.

PERIOD OF PERFORMANCE:

Base Year 1/1/2027-12/31/2027
Option Year 1 1/1/2028-12/31/2028
Option Year 2 1/1/2029-12/31/2029
Option Year 3 1/1/2030-12/31/2030
Option Year 4 1/1/2031-12/31/2031

Note: This facility is not subject to local or State requirements. Vendor will ensure compliance with Federal requirements only.

PERFORMANCE OF WORK:

The awarded contractor must provide CETA certified technician(s) to complete the following clean room testing monthly USP Chapter <797> & <800> compliance testing of the facility Sterile Compounding Suites. The suites consist of three areas: (1) chemotherapy IV compounding room(s), which contains biological safety cabinets, (2) non-hazardous IV compounding rooms which include laminar flow hoods, and (3) ante rooms. Surface viable sampling includes dual incubation for bacterial and fungal growth detection, count, and colony identification when warranted. Building 1: 14 locations, 1 control. Building 24: 26 locations, 1 control. The vendor’s technician shall provide copies of the all-field reports before departing VACCHCS. Any viable samples taken will have results sent within 10 business days upon receipt by the lab. If any organism identification is requested for the viable samples taken to the Genus or Species, there will be associated costs additional to the base price. If the ID is requested, the vendor will need to be notified as the lab that processes the samples only holds on to them for 30 days once the lab receives the samples. The vendor shall summarize all test results and send a Formal Report Summary that will have all test data, sampling diagrams, room and HEPA filter maps, copies of calibration certificates of all standards used, and applicable test criteria/standards. Standard turnaround should be within 60 days.