VACCHCS Pharmacy Certification

This document is a U.S. Department of Labor Service Contract Act (SCA) Wage Determination (No. 2015-5609, Revision 29, dated May 13, 2026) for federal contracting in Fresno County, California. It establishes mandatory minimum hourly wage rates and fringe benefit requirements for various labor categories across administrative, healthcare, maintenance, technical, and service occupations. Key requirements and compliance provisions include: • Health & Welfare Benefits: Mandatory contractor contributions of $5.55 per hour (up to 40 hours weekly), or $5.09 per hour for contracts subject to Executive Order 13706 paid sick leave requirements. • Paid Leave: Minimum of 11 paid federal holidays annually and 2 to 4 weeks of paid vacation based on length of service. • Executive Orders: Outlines contractor obligations under EO 13706 (accruing up to 56 hours of paid sick leave annually) and EO 13658 (minimum wage rates for covered federal contracts). • Differentials & Allowances: Defines rules for hazardous duty pay differentials (4% or 8%), night/Sunday pay premiums for specific occupations, and required uniform provisioning or laundering allowances ($3.35 per week). • Exemptions & Conformance: Specifies FLSA exemptions for professional computer employees and outlines the Standard Form 1444 (SF-1444) conformance process for adding unlisted job classifications.

Attachment 1 outlines the Quality Assurance Surveillance Plan (QASP) for a federal contract requirement, establishing critical performance objectives, standards, and surveillance methods. The document sets a zero-tolerance policy for non-compliance, stating that failure to meet the minimum acceptable service thresholds will lead to contract termination for default. The plan mandates 100% inspection across three core operational areas: 1. Inspection Service Frequency/Interval: Certification testing must adhere strictly to PWS Section 2 and achieve 100% compliance with VA Directives and regulations, allowing zero deviation. 2. Reports: All required documentation must be accurate, complete, and submitted on time 100% of the time, with no discrepancies permitted. 3. Qualified Personnel: All assigned staff must meet specified CETA certification requirements 100% of the time without exception. Overall, this QASP enforces rigorous oversight to ensure complete compliance with Performance Work Statement (PWS) standards and maintain mission success.

This document comprises a series of semi-annual certification and testing reports performed by Technical Safety Services (TSS) in August 2026 for the VA Fresno facility (Building 1/2615). The certification evaluates the Inpatient Pharmacy IV Room, Ante Room, and Hazardous Storage Room to verify compliance with USP <797>, USP <800>, CETA CAG-003, and ISO 14644-1:2015 standards. Key findings and certified areas include: - Primary Engineering Controls (PECs): Two Baker Clean Benches (Model EG4252, Serial Nos. 86796 and 86809) in the Inpatient Pharmacy IV room passed all physical airflow, HEPA filter leak, ISO Class 5 airborne nonviable particle count, and dynamic smoke visualization tests. - Secondary Engineering Controls (SECs): The Ante Room (ISO-8 design), IV Room (ISO-7 design), and Hazardous Storage Room met all required specifications for supply/exhaust airflow volumes, HEPA filter integrity, room air exchange rates (AC/H), differential pressure isolation, and nonviable particle cleanliness. - Environmental Monitoring: Active air and surface viable sampling were executed across ISO-5, ISO-7, ISO-8, and controlled non-classified (CNC) zones to assess microbial contamination levels. All tested equipment and room environments passed their respective inspection criteria, maintaining valid certification status through February 2027. All testing utilized NIST-traceable instrumentation.

Technical Safety Services (TSS) performed preliminary pharmacy testing and certification services at the VA Fresno facility (Building 24) on September 10, 2026, in compliance with USP <797>, CETA, and ISO standards. The evaluation encompassed primary engineering controls, cleanrooms, and environmental controls within the facility's sterile compounding suite, including hazardous and non-hazardous sterile buffer rooms, an anteroom, and a storage room. Key findings confirmed that all tested equipment and cleanroom areas passed critical performance criteria. Four Nuaire primary engineering controls—comprising two Class II, Type A2 Biological Safety Cabinets and two horizontal laminar flow clean benches—achieved full certification. Tests for inflow and outflow velocity, HEPA filter integrity, airborne non-viable particle counts (ISO Class 5), and dynamic airflow visualization studies were completed successfully. Additionally, secondary engineering controls met all operational requirements for differential pressure, room air exchange rates, HEPA leak testing, and ISO Class 7 non-viable particle thresholds. A total of 35 environmental air and surface viable samples were collected across the suite, with laboratory incubation and enumeration results pending separate delivery to facility contacts. All test equipment utilized was certified and NIST-traceable. Retesting and re-certification are scheduled for March 2027.

This document is a preliminary Pharmacy Summary Report and technical certification record submitted by Technical Safety Services (TSS) for the VA Fresno facility (Building 1). Conducted on August 3, 2026, the testing verifies that the inpatient pharmacy's controlled environment equipment and sterile compounding areas comply with USP <797>, USP <800>, CETA CAG-003, and ISO standards. Key testing performed and results include: - Unidirectional Flow Workstations: Two Baker clean benches (Serial Nos. 86796 and 86809) in the IV room passed airflow velocity, HEPA filter leak tests, non-viable particle counts (ISO Class 5), and dynamic airflow visualization studies. - Sterile Compounding Cleanrooms: The ISO Class 8 Ante Room and ISO Class 7 IV Room met all requirements for room air exchange rates, HEPA leak testing, non-viable particle counts, and positive differential pressure. - Hazardous Storage Room: Passed room air exchange rate and negative differential pressure criteria. - Environmental Monitoring: Viable active air and surface samples (28 total) were collected across cleanroom zones, with laboratory incubation results pending separate delivery. All tested primary and secondary engineering controls were certified as compliant, with a scheduled retest date set for February 2027.

This certification report documents environmental and equipment performance testing conducted at the VA Fresno facility (Building 24 Pharmacy) in September 2026 under Project ID NC-VFR2627401A-1. Field service technician Daniel Velazquez inspected and certified several biological safety cabinets (Class II, Type A2), unidirectional clean benches, and pharmacy compounding spaces to ensure compliance with federal and industry standards, including USP <797>, USP <800>, CETA CAG-003, ISO 14644-1:2015, OSHA, and ANSI/NSF 49. The scope of testing encompassed calculated inflow and supply air velocities, HEPA filter leak integrity, airflow visualization studies (smoke pattern tests), airborne nonviable particle counts, and viable air/surface environmental sampling across hazardous and non-hazardous sterile buffer rooms and ante-rooms. All tested units—including Nuaire biological safety cabinets and clean benches—passed their respective performance criteria, demonstrating proper unidirectional airflow, ISO Class 5 air cleanliness standards, and functional system alarms. Standard NIST-traceable calibrated equipment was utilized for all measurements. Re-certification and re-testing for the certified containment devices and sterile compounding environment are scheduled for March 2027.

This document provides room designations for pharmacy or cleanroom facilities located in Building 1 and Building 24. For Building 1, it identifies the Ante Room (1B06C), Non-HD Room (1B06C.1), out-of-service HD Room (1B06C.2), and HD storage room (1B06F). For Building 24, it outlines the locations for the HD storage Room (3A14E), Ante Room (3A14D), HD Room (3A14C), and Non-HD Room (3A14B).

This document is Amendment 0001 to Solicitation 36C26127Q0099, issued by the Department of Veterans Affairs (VA) Network Contracting Office (NCO) 21 for VACCHCS Pharmacy Certification services. The primary purpose of this amendment is to address vendor questions and provide formal answers, along with supplemental technical attachments. Key clarifications provided in the amendment include: • Confirmation that floor plans, current asset lists, and recent certification reports are provided as attachments. • Requirement that offerors include all testing elements—such as particle counts and airflow visualization studies—within their certification testing pricing. • Clarification on out-of-cycle testing, specifying one test event per building location annually, following the same testing parameters as routine semi-annual testing unless specified otherwise by the Contracting Officer's Representative (COR). • Identification of specific Building 1 rooms required for differential pressure and air-change measurements (HD Storage Room, Ante Room, and Non-HD Room). The amendment also attaches supporting technical files, including floor plans and recent USP testing certification reports for Buildings 1 and 24. All other terms and conditions of the original solicitation remain unchanged.

This Request for Quotations (RFQ 36C26127Q0099), issued by the Department of Veterans Affairs Network Contracting Office (NCO) 21, solicits commercial pharmacy testing services for the VA Central California Healthcare System. The required services encompass United States Pharmacopeia (USP) 795, 797, and 800 certification testing across primary facilities (Buildings 1 and 24). Specific tasks include biological safety cabinet and laminar flow clean bench certifications, particle counts, airflow video studies, terminal air filter testing, room differential pressure and air exchange measurements, as well as viable air and surface sampling. The procurement is unrestricted under NAICS code 541380 (Testing Laboratories and Services) with a $19 million size standard. The contract features a five-year period of performance, consisting of a one-year base period running from February 5, 2027, through February 4, 2028, and four subsequent one-year option periods extending through February 4, 2032. Quotes are due by November 2, 2026, at 10:00 AM PDT to Contracting Officer Cynthia Diezel. Invoices will be submitted monthly in arrears via the Tungsten Network electronic invoicing portal.