H966--PHARMACY USP 797 800 CERTIFICATION TESTING

SUBJECT* PHARMACY USP 797 800 CERTIFICATION TESTING GENERAL INFORMATION CONTRACTING OFFICE’S ZIP CODE* 95652 SOLICITATION NUMBER* 36C26126Q0754 RESPONSE DATE/TIME/ZONE 06-09-2026 10AM PACIFIC TIME, LOS ANGELES, USA ARCHIVE 30 DAYS AFTER THE RESPONSE DATE RECOVERY ACT FUNDS N SET-ASIDE PRODUCT SERVICE CODE* H966 NAICS CODE* 541380 CONTRACTING OFFICE ADDRESS Department of Veterans Affairs Network Contracting Office (NCO) 21 POINT OF CONTACT* Contracting Officer Cynthia Diezel cynthia.diezel@va.gov 916-923-4567 PLACE OF PERFORMANCE ADDRESS VA Central California Health Care System 2615 E Clinton Ave Fresno, CA 93703 POSTAL CODE COUNTRY ADDITIONAL INFORMATION AGENCY’S URL URL DESCRIPTION AGENCY CONTACT’S EMAIL ADDRESS EMAIL DESCRIPTION DESCRIPTION Performance Work Statement (PWS) Pharmacy USP 797 & 800 Certification Testing VA Central California Health Care System BACKGROUND: The VA Central California Healthcare System (VACCHCS), Fresno VA Medical Center requires 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>, International Organization for Standardization (ISO), and VHA Directive for sterile compounding clean rooms. The VA Central California Healthcare System is requesting a base year contract with up to four (4) option years to be included for this service. SCOPE OF WORK: The awarded vendor must provide CETA certified technician(s) to complete the facility’s clean room testing semi-annually, not to exceed 180 days between test dates. Currently, the active compounding suites are tested in August and February. The vendor shall adhere to the most current version of the reference codes as applicable to the clean suite being certified. USP<795> USP<797> USP<800> International Organization for Standardization (ISO): ISO 14644 The Joint Commission for Healthcare Accreditation VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounded Sterile Preparations VHA Directive 1108.06 Inpatient Pharmacy <USP>797 & 800 compliance testing of the facility Sterile Compounding Suites shall be performed. Building 1: The suite consists of four rooms: a Hazardous Drug Room, which contains a biological safety cabinet, a Non-Hazardous Drug Room which contains two laminar flow clean benches, and one Ante Room, and an adjacent Hazardous Storage Room. The Hazardous Drug Room is out of service and is not to be included in the testing requirements. Building 24: The suite consists of 5 rooms: a Hazardous Drug Room, which contains two biological safety cabinets, a Non-Hazardous Drug Room which contains two laminar flow clean benches, one Ante Room, one Entry Room and one Hazardous Storage Room. Comprehensive testing in accordance with <USP797>, <USP800>, and CETA Application Guides (CAGs) shall be implemented for all rooms, equipment and appetences therein. The following are minimum requirements, however CETA Application Guides (CAGs) shall govern the testing if more restrictive or comprehensive than the elements described below. Airflow volume and velocity measurements of ceiling High-Efficiency Particulate Air (HEPA) Terminal Air Filters (TAFs) to ensure both unidirectional and non-unidirectional flow areas are properly balanced, and unidirectional zones are maintaining proper air patterns. HEPA filter integrity leak testing of HEPA TAFs. Certification testing of (2) Biological Safety Cabinets. To include nonviable particle counts. Airflow visualization studies to determine the path(s) of the air flowing in and around the biological safety cabinets and the Laminar Flow Clean Benches. A video log must be provided to the agency to have smoke studies on record. Certification testing of (4) Laminar Flow Units (Clean Benches). To include nonviable particle counts. Particulate counting of cleanroom(s): Non-HD Rooms, HD Room, and Ante Rooms. Differential pressure measurements for all rooms. Determine the room air exchange rate (ACH), to confirm a proper ventilation rate is achieved. Testing of Pass-through boxes (Single Pass Boxes). Viable particle sampling: airborne and surface. To include count and identification to the genus level. TSA media dual incubated for bacterial and fungal growth detection, colony identification on samples that show growth. Note: This facility is not subject to local or State requirements. Vendor will assure compliance with Federal requirements only. Stickers indicating the condition, at the time of the testing, and indicating a pass or fail determination, shall be applied to all rooms and equipment prior to the technician departing the Fresno VA facility on the day of field testing. A preliminary report of findings should be provided digitally, via e-mail, to the contracting officer’s representative within 24-hours of the completion of the semi-annual service visit. An official/final report will be required to be provided to the contracting officer’s representative (COR) within 30 days of completed service. The official/final report shall be sent digitally. Modifications to room configurations or equipment configurations or failed tests may prompt the need for out- of-cycle certification testing. Supplemental testing may be incorporated through contract modification issued by the Contracting Officer when required by the government. CONTRACTOR QUALIFICATIONS: Contractor technicians assigned to certification testing at the Fresno VA must be CETA Certified. There must be a minimum of 3 CETA certified staff members on staff. Contractor must be located with- 250-mile geographical radius of the Fresno VA and be able to dispatch a certified technician to arrive at the Fresno VA within the same business day. Contractor personnel performing service on this contr…