Inactive Total Small Business Set-Aside (FAR 19.5)

Page 1 of 2 The following is a Sources Sought/Request for Information notice. This posted notice is not Pre- Solicitation or Solicitation document. The government is not currently soliciting bids, quo... Page 1 of 2 The following is a Sources Sought/Request for Information notice. This posted notice is not Pre- Solicitation or Solicitation document. The government is not currently soliciting bids, quotes or proposals at this time; however, reserves the right to do so at a later date. The VA Healthcare System is seeking potential sources for Controlled Environment Testing Association (CETA) Certifications. There is nine VA hospitals located in the state of Pennsylvanian. As a result, two separate solicitations for West - Altoona, Butler, Erie and Pittsburgh; and East Coatesville, Lebanon, Philadelphia, Wilkes-Barre, and Wilmington will be posted on SAM. Interested parties will be able to provide quotes for one or both East and West locations. See last page for all locations. STATEMENT OF WORK VISN 4 East Pharmacy Controlled Environment Testing Association (CETA)Certifications Department of Veterans Affairs (VA) Veterans Integrated Service Network (VISN) 4 PURPOSE VISN 4 is pursuing a VISN contract for comprehensive testing, certification, preventive maintenance, repair, and filter replacement services for chemical hoods, HEPA filtration systems, and other critical containment and ventilation equipment, standardizing testing criteria appropriate for all primary engineering controls (PECs), Secondary Engineering Controls (SECs), and Segregated Compounding areas (SCAs) used pursuant to United Staes Pharmacopeia (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 (CETA Application Guide, CAG-003) 2022 (or current version). Although USP <797> states that certification procedures such as those outlined CAG-003-2022 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2022 be used in lieu of any other such as procedures that may exist. Testing procedures shall be maintained in compliance with all current applicable standards. CAG 001-2005 CETA Guide for the use of Compounding Aseptic Isolators in Healthcare Facilities, Revised December 8, 2008 and CAG-002-2006 CETA Compounding Isolator Testing Guide Revised December 8, 2008, or current guidelines, will also be used as the applicable standard for their respective PEC. The requested services shall include certification of Primary and Secondary Engineering Controls (PECs/SECs), Biological Safety Cabinets (BSCs), Laminar Airflow Workstations (LAFWs), Compounding Aseptic Containment Isolators (CACI), Compounding Aseptic Isolators (CAI), Restricted Access Barriers (RABs), cleanroom environments, and air handling systems for VISN 4Pharmacy Services. Testing shall include smoke pattern testing (with video), viable and non-viable microbial sampling, total particle count testing, airflow and pressure testing, and HEPA filter integrity testing. BACKGROUND The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of Compounded Sterile Preparations (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 -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. VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated February 14, 2024, defines organizational responsibility for USP <797> and USP <800> standards for cleanroom design and engineering controls, environmental monitoring and cleaning of primary and secondary engineering controls, and the core competencies for personnel involved in the processes of compounding sterile preparations including Hazardous Drugs (HDs) (both sterile and nonsterile dosage form preparations). 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 and USP <800> Hazardous Drugs Handling in Healthcare Settings. PERIOD OF PERFORMANCE The contract type is a Firm-Fixed Price, Indefinite Delivery, Indefinite Quantity (IDIQ) with a five-year period of performance. Ordering Period One: February 24, 2026 February 23, 2027 Ordering Period Two: February 24, 2027 February 23, 2028 Ordering Period Three: February 24, 2028 February 23, 2029 Ordering Period Four: February 24, 2029 February 23, 2030 Ordering Period Five: February 24, 2030 February 23, 2031 CONTRACTOR REQUIREMENTS Prime contractor must be CETA certified and currently registered with CETA. A current Controlled Environment Testing Association (CETA) certification to perform the necessary testing on the equipment specified for each technician performing contract work on the Pharmacy Compounding Engineering Controls. Provide proof of certification and CETA registration with solicitation. Adherence with the most current versions of the following reference standards: CAG-001: CETA Applications Guide for the use of Compounding Aseptic Isolators in Compounding Sterile Preparations in Healthcare facilities (Revised 2008) CAG-002: CETA Compounding Isolator Testing Guide (Revised 2006) CAG-003: Certification Guide for Sterile Compounding Facilities for USP Compliance (Revised 2022) CAG-004: Biological Decontamination and Disinfection of Accessible Surfaces in Biosafety Cabinets (Revised 2020) CAG-005: Servicing Hazardous Drug Compounding Primary Engineering Controls (Revised 2025) CAG-006: Procurement, Utilization, and Disposal of HEPA and ULPA Filters (Revised 2023) CAG-007: Exhaust System Requirements of Class II Biosafety Cabinets (Revised 2020) CAG-008: Certification Matrix for Sterile & Nonsterile USP Compounding Facilities (Revised 2022) CAG-009: Viable Environmental Monitoring for Sterile Compounding Facilities (Revised 2023) CAG-014: Airflow Visualization Study (New 2022) CAG-015: Testing of Pass-Throughs (New 2025) ISO (International Organization for Standardization) 14644-1:2015 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration ISO 14644-2:2015 - Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration ISO 14644-3:2005 Cleanrooms and associated controlled environments -- Part 3: Test methods ISO 14644-9:2012 Cleanrooms and associated controlled environments -- Part 9: Classification of surface cleanliness by particle concentration ISO 14698-2:2003 - Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data Manufacturer performance requirements.-NSF (National Sanitation Foundation International)/American National Standards Institute (ANSI) 49-2016 Biosafety Cabinetry: Design, Construction, Performance and Field Certification USP (United States Pharmacopeia Convention) Chapter <797> Pharmaceutical Compounding Sterile Preparations (Revised 2023) USP Chapter <800> Hazardous Drugs Handling in Healthcare Settings (Revised 2023) OSHA (Occupational Safety and Health Administration) EPA (Environmental Protection Agency) Adherence to VHA Directives Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated February 14, 2024; VHA Directive 1108.07 General Pharmacy Service Requirements, dated November 28, 2022; VA Medical Center policies and procedures, including donning the required PPE provided by VA Pharmacy which include: Gloves Gowns Eye Protection Face Mask, Respiratory Protection Head, Hair Covers, and Shoe Covers. The contractor is responsible for following all site-specific requirements to gain access to the buildings, which will be relayed to the contractor by the Technical Point of Contact TPOC. The contractor must provide a designated point of contact for VA Pharmacies to correspond with as needed. GENERAL PERFORMANCE REQUIREMENTS The contractor shall provide all labor, materials, tools, and test instruments required to inspect, test, certify, maintain, and repair the compounding engineering controls per the established standards. All parts and materials shall be of the original manufacturer s design and specification, or equal thereto. The replacement of HEPA filters and pre-filters will be included in the respective certification where necessary. Each VA Medical Center will provide the required replacement filter. For a list of the relevant items, see Attachment A. The number of items in service may change throughout the contract period. The numbers and types of devices in Attachment A are the Government's best estimate of the number and type expected to be serviced by the contract. The Government reserves the right to delete or add units as required. If units are added or deleted, a bilateral modification (an agreement in price by both the CO and contractor) will be issued by the Contracting Officer. If an agreement cannot be reached, the Contracting Officer reserves the right to award a contract for the additional equipment to another contractor. All travel costs associated with the performance of this contract are the responsibility of the Contractor and are provided at no additional cost to the Government. Travel costs are defined as, but are not limited to, time and vehicle costs for personnel in travel to and from job site for all duties, normal shipping charges on any parts or materials covered, costs associated with the normal shipping of parts or equipment out for repair that are covered. The contractor is responsible for ensuring surface and air microbial samples collected during the certification process are received by an independent laboratory with ISO 17025 certification no later than the end of the following business day. Collection media used must support microbial and fungal growth as specified in the Certificate of Analysis for each lot. Certificates of analysis must accompany each Certification Report. The laboratory should process samples in accordance with CAG-009, Viable Environmental Monitoring for Sterile Compounding Facilities. It is the expectation of the VISN 4 Pharmacy to be notified of any microbial growth immediately after it is identified. The Contractor must notify the VISN 4 Pharmacy of results no later than 48 hours after the report is received from the laboratory. It is the expectation of the VISN 4 Pharmacy that the final report is received within 10 to 14 days after certification. SPECIFIC REQUIREMENTS Frequency of certification Certification required every 6 months. Certification schedules for certain Primary and Secondary engineering controls at each facility must be staggered in order to ensure continuity of operations in the case of failure. The alternating certification schedule is denoted by the blue/green color in Attachment A. Additional certification is required after microbial failures, maintenance work, major construction, and equipment movement or repair. The contractor must perform additional certification within 7 days of any event that requires it. The contractor shall maintain a database of the equipment contained in this contract and initiate the coordination for testing 45 days prior to the due date to ensure timely certification. Equipment and areas to be Certified: A list for each facility s configurations is in Attachment A. The specific model and serial number of PECs included in Attachment A are subject to change when replacement is needed. The contractor s quote shall include pricing for the current configuration of each VISN 4 Pharmacy s Engineering Controls and itemized options for addition or replacement of PECs, SECs, or Containment-Segregated Compounding Areas (C-SCAs) as needed. Certification requirements All testing to be performed in a Dynamic Operating Conditions. Testing to the specifications listed in the current version of the CETA Guides, International Organization of Standardization (ISO) document Cleanrooms and associated controlled environments, Institute of Environmental Sciences and Technology Recommended Practice Unidirectional Flow Clean Air Devices, IEST-RP-CC-002.4, The United States Pharmacopeia General Chapters 797 and 800, VHA Directive 1108.12, and equipment manufacturers specifications and operating procedures. Each PEC testing requirements include: HEPA filter leak test Surface microbial and fungal sample collection from the work surface Air microbial and fungal sample collection from inside each PEC Non-viable particle counting inside each PEC to calculate the ISO rating Smoke pattern test during dynamic operating conditions HEPA diffuser cleaning according to manufacturer specifications Pre-filter check/vacuum if required by manufacturer specifications Each SEC testing requirements include: HEPA filter leak test for in ceiling and pass-through HEPA filters Airflow measurement for each SEC including total supply from the room and total supply from the PECs to calculate Air Exchanges Per Hour (ACPH). Surface microbial and fungal sample collection from at least one high-touch area of each SEC and each pass-through. Air microbial and fungal sample collection from each SEC. Non-viable particle counting to calculate the room ISO rating. Pressure differential between each pair of SECs and between the Ante rooms and the general pharmacy area Temperature and humidity Each C-SCA testing requirements include: Pressure differential between C-SCA and general area Airflow measurement for each SEC including total supply from the room and total supply from the PECs to calculate Air Exchanges Per Hour (ACPH) Temperature and humidity. Cleanroom Pass-Thru System Certification / HEPA Filter Change HEPA filter leak test Surface microbial and fungal sample collection from the work surface. Air microbial and fungal sample collection from each. Non-viable particle counting to calculate the ISO rating. Reports and Documentation The contractor will immediately notify the Medical Center Point of Contact with any results indicating failure. A final formalized written report including all required aspects specified in this Statement of Work must be sent via email to the address specified in Attachment A for each site, no more than 14 business days from certification evaluation. Immediately upon completion of a certification a preliminary service report must be issued with all findings from the testing performed on-site. This report should contain: Name of the CETA-certified technician performing testing List of equipment used for the testing, manufacturer, model, serial number, and calibration due date Each PEC and SEC nonviable particulate counts and ISO classification Each SEC ACPH Pressure differentials between each SEC and the Ante room/pharmacy Temperature and Humidity Results of HEPA leak tests for all filters tested The certification tag must be updated on each of the PECs that passes the certification. The final certification report includes the information in the preliminary report in addition to: Video recording of all the smoke pattern tests delivered via mail on a CD-ROM or be made available for download on a secure website. A diagram of the areas tested, noting the approximate location of surface, air, and particle counts, the pressure differentials between spaces and the direction of airflow. Trending data of major findings including ACPH, Pressure differentials, temperature, humidity, HEPA lifespan. Specific recommendations for next HEPA filter replacement to provide adequate time to obtain the filter (if VA provided) and minimize downtime/failures. All PEC reports must contain at minimum: Type, make, model and serial number Airborne particle counts for each location tested, sample volume, sample time and ISO classification. Measured air velocity data CFM, Average and standard deviation of air velocity measurements and acceptance criteria PEC dimensions, calculated volume Calculated ACPH and pass/fail rating Blower setting and pressure gauge reading (if any) Supply HEPA filter size/area and estimated lifespan remaining Supply HEPA filter leak test method, result, whether penetration was detected If leaks were detected and sealed, a diagram showing the approximate location of the sealed leaks. Prefilter type, size, and condition. Results of the smoke pattern tests (airflow and dynamic). Alarm test results (if any) Site installation assessment test results Certification results and performance standard used Additional report requirements for specific PEC types: Biological Safety Cabinet PEC reports must contain: Measured downflow air velocity data, acceptance criteria and pass/fail result Measured exhaust damper acceptance criteria and pass/fail result Inflow velocity test method, measurements and results Sash height Exhaust HEPA filter size and estimated lifespan remaining Exhaust HEPA filter leak test method, result, whether penetration was detected. If leaks were detected and sealed, a diagram showing the approximate location of the sealed leaks. If no leaks, statement that no leaks in excess of the maximum allowable 0.01% were detected. Results of smoke air flow pattern tests for downflow, view screen retention, opening edge retention, and sash seal (if sliding sash). Electrical safety test results Alarm test Compounding Aseptic Isolator and Containment-Compounding Aseptic Isolator PEC reports must contain: Door interlock verification test Chamber pressure test results View retention latch integrity Mag gauge readings Measured air velocity data for both chambers, acceptance criteria and pass/fail result Site installation assessment: alarms, interlock operations, canopy connection and performance Preparations Ingress and Egress Test Particle count at both static and dynamic operating conditions in the main chamber and static conditions in the ante chamber CACI reports must also contain: Exhaust HEPA filter size/area and estimated lifespan remaining Exhaust HEPA filter leak test method, result, whether penetration was detected If leaks were detected and sealed, a diagram showing the approximate location of the sealed leaks. Particle Containment Integrity and Enclosure Leak Test Fume Hood reports must contain: Inflow velocity Airflow smoke patterns Cabinet integrity test Room air interference test Exhaust and Exhaust alarm test. SEC reports must contain: Air flow supplied from each in-celling HEPA filter Room dimensions Total ACPH Static pressure and direction between adjacent rooms Number of people present during testing Air pattern analysis to confirm pressure direction at all points around openings (doorways, passthroughs) Particle counts at each location tested and resultant ISO classification Temperature and humidity readings HEPA filter make/model, size/area and estimated lifespan remaining for each in-ceiling and passthrough HEPA filter HEPA filter leak test method, result, whether penetration was detected, and the type of instrument used for testing. If leaks were detected and sealed, a diagram showing the approximate location of the sealed leaks. If no leaks, statement that no leaks in excess of the maximum allowable 0.01% were detected. Alarm test results (if any) Certification results and performance standard used C-SCA reports must contain at minimum ACPH Pressure differential between C-SCA and adjacent space Temperature and Humidity Microbiology reports must contain at minimum Incubation temperature and duration of incubation Certificate of Activity/Quality for each media lot Positive and negative controls Results of surface and air samples indicating the sampling location and identified to the genus level. Monograph for each genus identified Determination of whether findings are actionable and action levels for each area sampled. Chain of custody for samples. RETESTING Equipment that needs to be retested due to repairs or filter change out shall be covered under this contract at the contract rate. REPAIRS Contractor shall provide on-site support within twenty-four (24) hours of notification for emergency repair and on-site support within seventy-two (72) hours for routine service requests outside of the scheduled services. Contractor shall furnish the VA POC with written estimate of cost to make necessary repairs and receive Contracting Officer (CO) approval prior to initiating repairs. A separate task order will need to be issued by the CO for repairs. No work shall be completed until the task order is issued and pricing is found fair and reasonable by the CO. CACI/CAI Sleeve Replacement may be requested during certification. The Sleeve Kit will be provided by the Government. ALL WORK TO BE COMPLETED AT THE FOLLOWING LOCATIONS: EAST Coatesville VA Medical Center1400 Blackhorse Hill Road, Coatesville, PA 19320 Lebanon VA Medical Center1700 South Lincoln Ave., Lebanon, PA 17042 Corporal Michael J. Crescenz VA Medical Center3900 Woodland Avenue, Philadelphia, PA 19104 Wilkes Barre VA Medical Center1111 East End Blvd., Wilkes-Barre, PA 18711 Wilmington VA Medical Center1601 Kirkwood Highway, Wilmington, DE 19805 WEST James E. Van Zandt VA Medical Center2907 Pleasant Valley Blvd., Altoona, PA 16602 VA Butler Health Care System353 North Duffy Road, Butler, PA 16001 Erie VA Medical Center135 East 38th Street, Erie, PA 16504 VA Pittsburgh Healthcare System Pittsburgh VA Medical Center - University Drive4100 Allequippa St., Pittsburgh, PA 15219 VA Pittsburgh Healthcare System H. John Heinz III VA Medical Center1010 Delafield Rd., Pittsburgh, PA 15215 ALL INTERESTED PARTIES MUST ALSO HAVE AN ACTIVE REGISTRATION IN THE SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE. TO REGISTER, PLEASE VISIT WWW.SAM.GOV. Responses to this notice shall include: Company Name Address Point of Contact Phone Number Email Address CAGE Code Unique Entity ID ** Note: Service-Disabled Veteran Owned (SDVOSB) and Veteran Owned (VOSB), who are interested in this procurement and consider themselves to have the resources and capabilities necessary to provide these services shall be verified with the U.S. Small Business Administration (SBA) https://www.sba.gov/federal-contracting. Process in 38 U.S.C. 8127(d) whereby a contracting officer of the Department shall award contracts on the basis of competition restricted to small business concerns owned and controlled by veterans, if the contracting officer has a reasonable expectation that two or more small business concerns owned and controlled by veterans will submit offers, and that the award can be made at a fair and reasonable price that offers the best value to the United States. For purposes of this VA specific rule, a service-disabled veteran-owned small business (SDVOSB) or a veteran-owned small business (VOSB), must meet the eligibility requirements in 38 U.S.C. 8127(e), (f) and VAAR subpart 819.7003. Please provide answers to all questions below regarding your firm s Socio-Economic status pursuant to North American Industrial Classification Code (NAICS) 541380: 1. Is your business a small business under NAICS 541380? YES ______ NO ______ 2. Is your firm a Veteran-Owned Small Business? YES ______ NO ______ 3. Is your firm a Service-Disabled Veteran-Owned Small Business? YES ______ NO ______ 4. Is you firm a certified HUB Zone firm? YES ______ NO ______ 5. Is your firm a Woman Owned business? YES ______ NO ______ 6. Is your firm a Large Business? YES ______ NO ______ 7. Do you have a GSA/FSS schedule for these items? YES______ NO______ Schedule Number: ___________________ Expiration Date: _____________________ Please provide a capability statement as well as any relevant literature addressing your organizations ability to supply the required items. Also, please include a point of contact name, phone number and email address. Note: Questions regarding this notice should be addressed to Loretta Payne via email only. NO PHONE CALLS WILL BE ACCEPTED REGARDING THIS REQUIREMENT. Please submit all responses to this notice via e-mail to: Loretta Payne Contracting Officer loretta.payne@va.gov Responses to this Sources Sought Notice are required by no later than Wednesday December 11, 2025, by 10:00 am EST. End of Document