SAM #36C24126Q0421

VISN 1 Environmental Monitoring, Testing, and Incubation Services for VA Pharmacies

This opportunity seeks a contractor to provide comprehensive environmental monitoring, testing, incubation, and certification services for all pharmacy clean rooms and primary engineering controls (PECs) across Department of Veterans Affairs VISN 1 facilities. - Government Buyer: - Department of Veterans Affairs, 241-Network Contract Office 01 (VISN 1), Connecticut VAMC, NCO 1 Contracting Office - OEMs and Vendors: - Baker (biosafety cabinets, laminar airflow workstations, compounding isolators, clean rooms at Providence VAMC) - Products/Services Requested: - Semi-annual and as-needed certification of PECs (biological safety cabinets, laminar airflow workstations, compounding isolators, clean rooms) - Viable and non-viable particle sampling - HEPA filter testing and replacement - Fume hood certification - Surface and environmental wipe sampling for hazardous drug residue - Personnel competency assessments (fingertip and media fill for new and ongoing employees) - Monthly and biannual surface sampling (hazardous and non-hazardous areas) - Unique or Notable Requirements: - All work must comply with USP 797/800 and CETA standards - Personnel must be CETA National Board of Testing (CNBT) and NSF 49 certified - Laboratory analysis must be performed by AIHA accredited labs - 100% Small Business set-aside under NAICS 541380 - Place of Performance: - All VISN 1 pharmacy locations, including Providence VAMC, Togus VAMC, White River Junction VAMC, Bedford VAMC, Boston Healthcare System, Manchester VAMC, Northampton VAMC, and Connecticut Healthcare System

Description

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 <!-- Additional items omitted for brevity --> 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 <797> 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 a VISN-wide contract for standardizing testing criteria appropriate for all PECs used pursuant to USP Chapter <797> and Chapter <800> 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. <!-- Additional sections omitted for brevity --> 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. <!-- Additional scope details omitted for brevity --> 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. <!-- Additional scope details omitted for brevity --> 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. <!-- Additional scope details omitted for brevity --> 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 <797>. Refer to the description of these tests in the section A.3.5.3 and A.3.5.4 for details. <!-- Additional scope details omitted for brevity --> A.3.5 USP<797> 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, 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, and a written report. <!-- Additional scope details omitted for brevity --> 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 obtained during 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 <797> standards as well as those referenced within the VHA HVAC Design Manual, which are more stringent than USP <797>. <!-- Additional scope details omitted for brevity --> 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 <797>. All readings and acceptance criteria shall be documented to at least one thousandth of an inch water column (e.g., 0.020 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). <!-- Additional scope details omitted for brevity --> 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. Air sampling shall test a sufficient volume of air (1000 liters) at each location. 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. <!-- Additional scope details omitted for brevity --> A.3.5.4 Monthly Surface Sampling, Personnel Competency Assessment, and Gloved Fingertip (GFT) and Media Fill Test (MFT) Monthly Surface Sampling: Samples will be taken from specified areas and analyzed in accordance with USP <797> standards. Personnel Competency Assessment includes gowning/garbing observation, GFT and MFT, and post-test surface sampling. GFT and MFT samples will be analyzed for CFU counts, with results reported accordingly. <!-- Additional scope details omitted for brevity --> A.3.5.5 Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semiannually, testing for drugs such as Cyclophosphamide, Ifosfamide, Methotrexate, Fluorouracil, and platinum-containing drugs. Additional drugs may be requested as needed. A minimum of 6 surface samples will be completed per certification, covering specified areas. <!-- Additional scope details omitted for brevity --> A.3.5.6 Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually, using current electronic equipment. Results must meet specified particle counts for ISO Class 5, 7, and 8 areas. <!-- Additional scope details omitted for brevity --> A.3.5.7 HEPA Filter Replacement and Minor Repairs The contractor shall replace HEPA filters during certification visits if needed, and perform minor repairs such as PEC decontamination, filter or blower replacements, as identified during certification. <!-- Additional scope details omitted for brevity --> A.3.5.8 Report Requirements Reports shall include an executive summary, recommendations, room details, testing dates, standards used, environmental results, particle counts, smoke test videos, personnel presence, and other relevant data. Pass/fail notifications should be included per test. <!-- Additional scope details omitted for brevity --> A.3.5.9 Report Distribution The contractor will notify points of contact immediately of any failures. A formal report will be provided within 14 days of certification. Reports will be sent via email, and additional site-specific reports will be provided to designated contacts. A quarterly schedule of pending visits will also be provided. <!-- Additional details omitted for brevity --> Testing Frequency Certification procedures per CETA CAG-003: every 6 months or upon room relocation/alteration. Environmental sampling (air and surface): quarterly or more frequently as needed. Environmental wipe sampling for hazardous drug residue: every 6 months or more frequently. STATEMENT OF WORK PART C: SUPPORTING INFORMATION C.1 Place of Performance Facility Name and Address (details per site) Specific PEC and Clean Room Information Per Site <!-- Providence VAMC details omitted for brevity --> C.2 Period of Performance Contract period: 5 years, performance begins 15 days from award. C.3 Special Considerations C.3.1 Contractor Furnished Materials All materials and tools required; staff must wear non-shedding clothing. C.3.2 Government Furnished Materials and Services Government will provide PPE, oversight, and some facilities support. C.3.3 Qualifications of Key Personnel References, certifications (NSF 49, CETA CNBT), and laboratory certifications are required. C.3.4 Security Requirements No security requirements; samples are retrieved by vendor. C.3.5 Additional Considerations Scheduling, procedures, after-hours work, and communication details. C.3.6 Invoicing Monthly in arrears via Tungsten Network; includes invoice details and contact info. Quality Control and Assurance Contractor to provide a QC/QA program; government may incorporate into QASP. Applicable FAR Provisions and Clauses FAR 52.212-1: Instructions to Offerors FAR 52.212-2: Evaluation Criteria FAR 52.212-4: Contract Terms and Conditions Additional Instructions Details on submission, exceptions, late submissions, and other procedures. Responses due by April 22, 2026, at 12:00 p.m. EST to jerry.choinski@va.gov. Questions should be directed to the Contract Specialist at the same email.

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