Q301--36C249-27-AP-0005 - Sterile Compounding Certification - (TVHS Pharmacy)

ion (FDA) has the authority to inspect VA medical facilities. VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated November 1, 2023, defines organizational responsibility for USP <797> standards for cleanroom design and engineering controls and environmental monitoring and biannual certification of these areas. It is VHA policy that each VA medical facility that provides CSPs have a pharmaceutical CSP program in place that conforms to the standards in USP Chapter <797> Pharmaceutical Compounding Sterile Compounding Sterile Preparations USP Chapter <797> standards require successful biannual certification of the areas and equipment and monthly environmental testing of the same and Chapter USP<800> requires further testing of hazardous drug areas. In addition, USP Chapter <797> requires biannual gloved fingertip and media fill testing of all compounding personnel. OBJECTIVE: VA Tennessee Valley Healthcare System (TVHS) seeks a contract for biannual certification, monthly viable surface and air testing, and personnel required testing. All testing must be in accordance with all applicable USP Chapter <797> and USP Chapter <800> standards, VHA Directive, medical center policies, standard operating procedures, and Controlled Environment Testing Association (CETA) guides. SCOPE OF WORK Bi-annual Certification: All primary and secondary engineering controls (SECs) must be tested to the most current CETA Certification and USP <797>, USP<800> guidelines every 6 months. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found Primary engineering control certifications for biologic safety cabinets and laminar airflow workstations to include (if applicable) Non-viable particle count Downflow Velocity test HEPA filter integrity leak test (and patching if needed) Low airflow alarm test Video airflow smoke studies Secondary engineering control certifications to include: Air changes Pressure differentials Non-viable particle counts Temperature and pressure monitor verification (note on report measured matches/does not match within 10%) HEPA filter integrity leak test (and patching if needed) Hazardous drug storage room testing to include: Air exchanges Pressure differential Temperature and pressure monitor verification. Monthly Viable Testing: All primary and secondary engineering controls must be tested for viable growth to the most current CETA Certification and USP797/USP800 guidelines monthly at both campuses. The Contractor will perform testing within the first 10 days of each month. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found Provide a viable sampling results report no later than 12 business days after testing completed. Provide retesting within the same month/prior to next scheduled time if there is a failure or other issue if requested by TVHS. Retesting should occur within 5 business days upon request by TVHS. Personnel Testing: Contractor will provide testing supplies for gloved fingertip and media fill testing for employees. Media must be in compliance with USP Chapter<797> TVHS designated employees will oversee the testing of compounders but utilizing supplies and lab services provided by the contractor. Contractor will provide Certified Environmental Microbiology Laboratory - ISO/IEC 17025:2005 Accreditation to incubate and report. Incubation, processing and reporting must be in accordance with USP Chapter <797>. Billing: All above services and other items (ie. per diem, travel etc.) billed in an itemized fashion and separately for each campus. Period of Performance Ordering Period 1: 10/01/2025-09/30/2026 Ordering Period 2: 10/01/2026-09/30/2027 Ordering Period 3: 10/01/2027-09/30/2028 Ordering Period 4: 10/01/2028-09/30/2029 Locations: Department of Veterans Affairs Tennessee Valley Healthcare System 1310 24th Avenue South Nashville, TN 37212-2637 Alvin C. York VAMC 3400 Lebanon Pike Murfreesboro, TN 37129-1237 REPORTING REQUIREMENTS: The Contractor must provide a preliminary report at the time of certification testing completion, viable sampling results reports no later than 12 business days after testing completed, and a comprehensive biannual certification electronic report no later than 45 business days after testing is completed, unless greater time is agreed upon in advance by the COR. Personnel testing reports must be received no later than 12 business days. All reports must include all items required by USP<797>, USP <800> and CETA testing. If the contractor cannot report within the specified timeline, an extension must be requested and agreed upon by TVHS. CONTRACTOR QUALIFICATIONS: The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work listed in Section 3. All testing and observations must be performed by properly trained and appropriately accredited on-site field certification technicians. These certified technicians must be trained on all the types of equipment listed in this SOW. All training and competency must be recent and in-date. Documentation shall be provided to the VA certifying that each field certification technician has been trained and certified in the work required by this SOW as follows: Contractor must have a working knowledge of most recent publications of USP<797> Pharmaceutical Compounding-Sterile Preparations Contractor must have a working knowledge of NSF/ANSI 49-2016 Biosafety Cabinetry: Design, Construction, Performance and Field Certification. Contractor must be able to provide a technician with current certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities by the CNBT for cleanroom certification. Proof of current CETA-accredited certification for a specific individual must be provided to facility s POC for the technician performing the work and/or the person who reviews and signs and reviews the reports. Contractor must follow all TVHS facility SOPs for the sterile compounding area at all times. Note: A Certified Industrial Hygienist (CIH) credential does not waive any of the above certification requirements. Technicians must successfully demonstrate competency in garbing and hand hygiene when performing work in classified areas. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will always maintain a clean work area by wearing appropriate personal protective equipment (set forth by USP <797> standards) and cleaning any equipment with at least 70% sterile isopropyl alcohol. Contractor must have working knowledge of current ISO standards. Contractor must have technicians available in a reasonable proximity to the facilities to eliminate/minimize travel expenses, to meet the time frames for testing and to accommodate possible multiple dates for testing each month if there is a failur