H266--Attention Jerry Choinski NC01 - Environmental Monitoring, Testing and Incubation VISN1 (VA-26-00020314)

COMBINED SYNOPSIS_ Environmental testing, incubation and certification of all the VISN 1 pharmacy locations_100% SB SET-ASIDE Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06 effective 10-01-2025. This solicitation is designated as a 100% Small Business (SB) set-aside. The associated North American Industrial Classification System (NAICS) code for this procurement is 541380, with a small business size standard of $19.0 million. The FSC/PSC is H266. The Department of Veterans Affairs is seeking a 5-year VISN 1 BPA requiring testing, incubation and certification of all the VISN 1 facility s primary engineering controls (PECs), and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). All specifications are required by VA pharmacy policy and USP 797/800 clean room regulations. All interested companies shall provide quotations for the following: ITEM NUMBER DESCRIPTION QUANTITY UNIT OF MEASURE COST 0001 Every 6 month room certification (Non-Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc. 1 Each 0002 Every 6 month room certification (Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc. 1 Each 0003 Every 6 month room certification (Ante/buffer)- including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc. 1 Each 0004 Every 6 month HOOD (Primary Engineering) certification (Non-Hazardous), including HEPA filter leak testing 1 Each 0005 Every 6 month HOOD (Primary Engineering) certification (Hazardous), including HEPA filter leak testing 1 Each 0006 Every 6 month Surface sampling (Non-Hazarous) 1 Each 0007 Every 6 month Surface sampling (Hazarous) 1 Each 0008 Monthly Surface Sampling (non-hazardous) 1 Each 0009 Monthly Surface Sampling (Hazardous) 1 Each 0010 Competency Testing (fingertip and media fill) - New Employee 1 Each 0011 Competency (fingertip and media fill) - Ongoing Employees 1 Each 0012 As needed room certification (Non-Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc. 1 Each 0013 As needed room certification (Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc. 1 Each 0014 As needed room certification (Ante/Buffer room) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc. 1 Each 0015 As needed HOOD (Primary Engineering) certification (Non-Hazardous), including HEPA filter leak testing 1 Each 0016 As needed HOOD (Primary Engineering) certification (Hazardous), including HEPA filter leak testing 1 Each Place of Performance Address: Department of Veterans Affairs All VISN 1 locations as listed below Country: UNITED STATES STATEMENT OF WORK PART A GENERAL INFORMATION A.1 INTRODUCTION: This requirement is for testing, incubation and certification of all the VISN 1 facility s primary engineering controls (PECs), and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstations (LAFWs) hoods, compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter 2022 (or most recent) guidelines and Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003). A.2 BACKGROUND: VISN 1 is pursuing VISN-wide contract for standardizing testing criteria appropriate for all PECs used pursuant to USP Chapter and Chapter standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent PEC certification procedures using the CETA Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003) 2022 (or current) version). The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the FD&C Act and applying the Insanitary Conditions at Compounding Facilities Guidance for Industry, November 2020 (or current version). Certification procedures defined in CETA CAG including, but not limited to, 003 (CETA Certification Guide for Sterile Compounding Facilities for USP Compliance), 014 (Airflow Visualization Study), and 009 (Viable Environmental Monitoring for Sterile Compounding Facilities) shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed. Documentation of competency and training related to the certification of primary and secondary engineering control for technician(s) who conduct on-site certification will be provided by the contractor. A.3 SCOPE OF WORK: A.3.1 NSF 49 Field Testing Requirements for Biological Safety Cabinets The contractor shall certify all Class II biosafety cabinets to the current version of NSF/ANSI 49-2020 (or higher) specifications as well as CETA CAG 003. All equipment used to certify biological safety cabinets shall have ISO/IEC 17025 accredited calibration certification. Any unit that fails to meet specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: Company name and address Unit make, model and serial number Report number Location (room number) Certification date Recertification date Technician signature A.3.2 Fume Hood/Testing and Certification The contractor shall test and certify each fume hood to the manufacturer s specifications. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the fume hood has an air flow monitor (AFM) or controller (AFC), the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: Company name and address Certification date Recertification date Average face velocity Sash height (only for fume hoods) Technician name and signature A.3.3 PEC Testing and Certification The contractor shall test and certify each PEC to the most current version of The Institute of Environmental Sciences (IEST) RP CC002 (Unidirectional-flow, clean-air devices), CETA CAG -003, and to the manufacturer s specifications. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to perform all testing. The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and backstreaming test. Any failures shall be reported directly to the identified site point of contact(s) as soon as practicable. Horizontal laminar flow cabinets shall be certified according to IEST RP-CC-002 Testing Laminar Air Flow Devices and in accordance with CETA CAG -003. All annual and semi-annual on-site certifications for Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The list of tests includes, but is not limited to: HEPA filter leak test Cabinet leak test Inflow velocity test to include exhaust airflow volume rate Airflow Smoke pattern test Electrical leakage and ground circuit resistance and polarity tests Lighting intensity test Vibration test Noise level test Ultraviolet (UV) lamp test Laminar Flow Hoods certifications must be accomplished in accordance with the most current version of the National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II Biosafety Cabinetry, Annex F, test method A-D, 1992 or most current issue. Fume hoods certifications must be accomplished in accordance with the most current version of the ANSI/ASHRAE 110-2016. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: Company name and address Unit make, model and serial number Report number Location (room number) Certification date Recertification date Technician name and signature A.3.4 Viable and Non-viable Particle Counts For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP . Refer to the description of these tests in the section A.3.5.3 and A.3.5.4 for details. A.3.5 USP Testing for Pharmacy Clean Rooms The contractor will provide comprehensive cleanroom testing and certification services every 6 months for required semi-annual certifications to include: HEPA filter integrity testing Airflow testing: Airflow testing is performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. Total particle count testing Room pressurization monitoring Temperature and Humidity monitoring Air pattern analysis Microbiological air and surface monitoring Dynamic airflow smoke pattern test for each PEC (contractor to leave video of smoke test on site prior to completion of certification process). Written Report Based upon findings noted in semi-annual certifications, or as necessary after an environmental excursion or physical change to the spaces or PECs occurs, additional applicable re-certification tests will be completed to reassess applicable areas and are included within this contract. A.3.5.1 Air Changes per Hour The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. Comparison of ACPH will be completed both for USP standards as well as those referenced VHA HVAC Design Manual, which are more stringent than USP . In the event that a room does not meet USP or VHA HVAC Design Manual requirements for ACPH the identified site POC(s) shall be informed immediately. A.3.5.2 Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP . All readings and acceptance criteria shall be documented to at least one thousandths of an inch water column (e.g., 0.020 w.g. and not 0.02 w.g.) or one tenth of a pascal (e.g., 2.5 Pa). Pressure differentials will be reflected on a report showing the sketch of the room(s). A.3.5.3 Viable Environmental Sampling The contractor shall perform viable environmental (air and surface) sampling every 3 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. While it is acceptable per USP standards to utilize Tryptic Soy Agar (TSA) media for bacteria, and another media specific to fungal VISN 1 requires all air samples to utilize TSA media which supports growth of both bacteria and fungi. Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location to maximize sensitivity. Samples of less than 1000 liters will not be acceptable. Surface Sampling: Surface samples will be collected in each room, the interior of each ISO Class 5 PEC, pass through chambers connecting to classified areas, and frequently touched surfaces. Surface sampling will be performed at the end of the largest CSP batch of the day. Any laboratory results equal to or greater than the action level will require notification of the POC(s) immediately upon receipt of results. Reports to include at a minimum: Date and time sampling was taken. All Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown to the genus level. Medial lots used for samples Comments indicating when dynamic conditions were used Certificates of analysis of media used Sketch identifying location of each sample obtained A.3.5.4 Monthly Surface Sampling, Personnel Competency Assessment, and Gloved Fingertip (GFT) and Media Fill Test (MFT) Monthly Surface Sampling: For those months without a scheduled semi-annual certification or quarterly environmental sampling collection, the contractor shall collect surface samples for the assessment of ongoing compliance. Surface samples will be taken from each of the following classified areas: Class 5 PEC Pass through chambers connecting to classified areas. Equipment contained within PEC Staging or work area(s) near the PEC Frequently touched surfaces Surface sample locations and quantity will be reviewed with and verified by local points of contact for each location by contractor. Surface samples will be collected, sent through the same laboratory used for viable environmental sampling, incubated with appropriate temperature and storage time, and analyzed all in accordance with 2022 USP (or more recent) requirements. Personnel Competency Assessment Contractor shall offer service to complete and document assessment of competency of compounding personnel including gowning/garbing observation, GFT and MFT, and post-test surface sample. Facilities will have the option to utilize contractor to complete competency assessment during scheduled monthly contractor onsite visits. If facilities elect to utilize this service, they will clearly communicate with the contractor at the time of visit scheduling of this need, as well as the number of staff requiring competency assessment. Gloved Fingertip (GFT) and Media Fill Test (MFT) If facility elects for contractor to complete competency assessment, contractor will include materials and assessment of GFT/MFT results in accordance with 2022 USP (or more recent) requirements. If facility elects to complete competency assessment internally, facility will capture GFT/MFT samples. Facility collected samples will be sent through contractor to same laboratory used for environmental sampling for consistency. Contractor and laboratory will ensure incubation temperatures, and storage times comply with 2022 USP (or more recent) requirements: Report: Through either contractor or facility captured GFT/MFT, contractor will utilize the same laboratory used for viable environmental sampling to incubate and analyze samples. Results will be reported as number of cfu per hand with notation of whether cfu action level is exceeded through reporting total number of cfu from both hands. Competency assessment and documentation will be in accordance with 2022 USP (or more recent) requirements. A.3.5.5 Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semiannually (e.g., every 6 months), or more frequently as needed to verify containment. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs. The drugs required for testing include: Cyclophosphamide Ifosfamide Methotrexate Fluorouracil Platinum-containing drugs Additional Drugs Additional drugs may be requested based upon identified need per site. Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing. A minimum of 6 surface samples will be completed per certification. Facilities can elect to work with contractor to expand beyond the minimum as they see fit but will be coordinated and communicated with contractor prior to certification visit. Surface sampling will include the following minimum areas: Interior of PEC and equipment contained in it. Pass-through chambers Surfaces in staging or work areas near PEC Areas adjacent to PECs (e.g., floors directly under C-PEC, staging, and dispensing area) Areas immediately outside the hazardous drug buffer room or C-SCA Patient administration areas A.3.5.6 Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually (e.g., every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following: ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW). ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room. ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room. A.3.5.7 HEPA Filter Replacement and Minor Repairs The contractor shall complete any identified HEPA filter replacement during certification visit in instances where a need is identified, and replacement is available on site. If HEPA filter changes must be postponed until a filter can be supplied, the contractor will install the new HEPA filter and conduct leak testing at an agreed upon time with the facility. The contractor shall complete additional minor repairs associated with clean room certification and operations that a…