H399--Hood & Cleanroom Cert Iowa City, IA VA Health Care System

REQUEST FOR INFORMATION/ SOURCES SOUGHT This is a sources sought notice only and it is not a solicitation announcement. The purpose of this sources sought notice is to gain knowledge of qualified potential contractors and their socio-economic size classification in accordance with NAICS code 541380. Responses will be used by the Government to make appropriate acquisition decisions. See the statement of work excerpt below; The Iowa City VA Health Care System, 601 Highway 6 W, Iowa City, IA 52246-2209 requires the following: Biosafety Cabinet, Hood, Pharmacy Cleanroom Certification that meet the following criteria; This requirement is for testing and certification of all the Iowa City VA Health Care System hoods either once a year (every 12 months +/- 30 days) or twice per year (every 6 months +/- 20 days) as described in the attached list. Hoods refers to all the following: Biosafety cabinets, chemical fume hoods, research animal housing units, research animal change stations and a HEPA unit for research animal allergen control during cage changes. A1.2 Certification of Primary Engineering Controls (PEC) and Secondary Engineering Controls (SEC) and/or Segregated Compounding areas (SCA) This requirement is also for testing and certification of all PECs, SECs and SCAs as described on the attached list. PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW), compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). All PECs, SECs and SCAs are certified twice a year (every 6 months +/_ 20 days) as described in the attached list. All PECs and SECs are certified twice a year (every 6 months +/_ 20 days) as described in the attached list. Testing and certification of all PECs, SECs and SCAs will be completed in accordance with the latest version of United States Pharmacopeia (USP) Chapter <797>, and USP Chapter <800> or current guidelines as delineated below A.2 BACKGROUND: The ICVAHCS is required to maintain all Hoods, PECs, SECs and SCAs that are in use for staff and product protection. This requirement will describe all testing and certification activities required for all Hoods, PECs, SECs, and SCAs All are considered engineering controls used for personnel protection and/or product protection and must be certified to industry standards to ensure they are providing the required protection. The ICVAHCS is pursuing a contract for standardizing testing criteria appropriate for all PECs, SECs, and SCAs used pursuant to current USP Chapter <797> and Chapter <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2022 or current guidelines. 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 United States Pharmacopeial Convention (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 Draft Guidance on Insanitary Conditions at Compounding Facilities which was published in August 2016. Certification procedures defined in CETA CAG-003-2022 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months (= or 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed. ICVAHCS is also pursuing contracting for the following tasks as outlined in current USP <797> and USP <800 >. Monthly surface sampling of described PECs, SECs and SCAs under dynamic operating conditions Semi-Annual viable air and surface sampling (Fungal and Microbial) of described PECs and SECs under dynamic operating conditions. Semi-annual Hazardous Drug (HD) Wipe Sampling of thirty pre-determined locations where HDs are handled. Locations will be determined by the COR in collaboration with Pharmacy. A semi-annual airflow Smoke Visualization Study of each PEC and SEC under dynamic operating conditions Replacement of cleanroom HVAC ceiling filters once every 5 years, including all room certification activities following the filter replacement(s) 2 hours of USP797/USP800 consulting A.3 SCOPE OF WORK: A.3.1 Hood and Primary Engineering Control Testing and Certification A3.1.1 Biological Safety Cabinets (BSCs), CACI, CAI, LAFW All certification of BSC, CAI, CACI and LFW shall comply with the latest version of NSF/ANSI Standard 49 Appendix F. A test report will be generated, and any comments or problems noted. The contractor will immediately notify the Contracting Officer s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR). Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the unit can be used. For each BSC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: - Company name, address, and phone number - Unit make, model and serial number - Report number reflecting the room certification - Location (room number) - Certification date - Recertification date - Technician signature A3.1.2 Chemical Fume Hoods All certification of Laboratory Chemical Fume hoods will comply with the latest version of ANSI/ASHRAE Standard 110. Face velocity testing and smoke visualization testing will be required; however, the tracer gas containment test using sulfur hexafluoride will not be required. The sash height achieving the required 100 fpm will be marked with a sticker designed for this purpose. A test report will be generated, and any comments or problems noted. Additionally, any fume hoods with face velocity monitors or controllers will be recalibrated to the correct velocity. The contractor will immediately notify the Contracting Officer s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR). Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the fume hood can be used. For each unit passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: - Company name, address, and phone number - Unit make, model and serial number - Report number reflecting the room certification - Location (room number) - Certification date - Recertification date - Sash height (only for fume hoods) - The average recorded face velocity - Technician signature A.3.2 CSP PEC Testing and Certification The contractor shall test and certify each PEC according to USP <797> and <800> using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2022), ANSI/NSF-49 and/or the CETA Applications Guide for the Use of Compounding Aseptic Isolators in Compounding Sterile Preparations in Healthcare Facilities (CAG-001-2005 Revised Dec. 8, 2008) and/or CETA Compounding Isolator Testing Guide (CAG-002-2006 Revised Dec. 8, 2008) or the equivalent. All PECs must: be certified to meet ISO Class 5 or better maintain unidirectional airflow be supplied by HEPA filtered air The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to: Viable and non-viable particle counts Airflow velocity testing HEPA filter leak test Induction leak/back-streaming test Cabinet leak test In-flow velocity test to include exhaust airflow volume rate Surface microbial and fungal sampling Air microbial and fungal sampling Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs). Airflow smoke pattern testing will be completed in accordance with CAG-003-2022 for each pharmacy PEC initially and when changes are made to the PEC or room configuration. The testing will be video recorded, and the contractor must have experience in collecting these videos. The facility will provide a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. The testing must show that first air conditions are achieved at the critical site during all compounding tasks within the respective PEC. This may mean that the contractor provides movement of the smoke source and/or multiple camera angles to ensure that each compounding task is effectively shown to be completed within an area receiving first air. It is important that the contractor recognize that this testing is beyond the typical scope of an equipment certification. These videos are to capture both the effective operation of the PEC and the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by CAG-003-2022. A3.2.1 Laminar Flow Hoods Biological Safety Cabinet (BSC)) must be tested and certified according to CETA CAG-003-2022 guidelines and to manufacturer s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices (to include Induction Leak/Back-streaming Test) and IEST-RP-CC034 HEPA Filter Leak Test. Certifications for Class II 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 contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POCs upon request. Confirmation of this calibration shall be listed in the final certification report. 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 back-streaming test. The contractor will immediately notify the Contracting Officer s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR). Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the fume hood can be used. A3.2.2 Restricted access barrier system (Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), and Isolators (i.e., PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006, Revised December 2008 and CAG-003-2022 guidelines and to manufacturer s specifications. The contractor will immediately notify the Contracting Officer s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR). Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the fume hood can be used. A.3.3 All CSP Facilities, SECs and SCAs, must be tested and certified in accordance with ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-03-2022 and CETA CAG-009-2020specifications. The contractor will provide comprehensive cleanroom testing and certification services with the frequency required by most current USP <797> standards and USP <800>. Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following: Non-Viable Particle Counting under dynamic operating conditions Viable / Microbial and Fungal Air Testing Viable / Microbial and Fungal Surface Testing Airflow Volume Measurements Air Velocity Profile Room Air Exchange Rates Room Pressure Measurement (in water columns) In-Place Leak Testing of HEPA Filters Temperature, Relative Humidity Measurements Smoke test under dynamic conditions A3.3.1 Viable and Non-viable Particle Counts for CSP Facilities For the PECs and SECs, 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> and <800>. If levels measured during surface and/or air sampling exceed the levels in the Table 1 below, an attempt must be made to identify any microorganism recovered to the genus level with the assistance of a microbiologist. Table 1. Action Levels for Viable Airborne Particle Air and Surface Sampling per USP <797> ISO Class Air Sampling Action Levels [cfu/cubic meter (1000 liters) of air/media device] Surface Sampling Action Levels (cfu/media device) 5 >1 >3 7 >10 >5 8 >100 >50 A.3.3.2 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, ante room, segregated compounding area (SCA) and HD storage room and include their findings in the report. If a room does not meet USP<797> or USP <800> requirements for ACPH the identified site POC(s) shall be informed immediately. A.3.3.3 Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas as well as the static pressure of the hazardous drug SCA and the hazardous drug storage room. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> (or USP <800> when applicable). The contractor shall report all pressures to an accuracy of 0.0001 water column (4 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s). A.3.3.4 Viable Environmental Sampling The contractor shall perform viable environmental (air) sampling every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. In addition, semi-annual viable environmental surface sampling of classified areas will be performed. This includes the hazardous and non-hazardous buffer rooms, the ante room, the HD storage room, and each segregated compounding area. When conducted, surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. Air and surface sampling shall be performed in the following areas: The interior of the PEC and the equipment contained in it Staging or work area(s) near the PEC Frequently touched surfaces Pass-through chamber(s) 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: The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) or Sab DEX contact plates for sampling of fungi. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. The lab chosen to analyze the samples must be verified prior to testing and be certifiedSpeciation requirements? . A.3.3.5 Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semi-annually (e.g., every 6 months). 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. Retesting, if required to mitigate any contamination found over a locally established action level, will be done by the ICVAHCS. The drugs required for testing includeIs this list still correct? : Cyclophosphamide Doxorubicin HCL Etoposide Irinotecan HCL Paclitaxel Cisplatin Carboplatin Oxaliplatin 5-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 total of 30 surface samples will be completed per certification. Surface sampling will include areas identified by Pharmacy staff, including but not exclusive to the following: Interior of PEC and equipment contained in it (i.e., camera). 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.3.3.6 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 per USP797, Section 4.1. A.3.3.7 Report Requirements: All of the following information should be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable. Reports to include at a minimum: Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown. The identification of highly pathogenic microorganisms will be highlighted in the report. Action level for ISO area tested Executive summary or summary of findings. Room number and/or location Room type (e.g., oncology prep room) Type of PEC certified Serial number of the equipment certified Bldg. Asset number of the equipment certified Date and time samples collected, and particle counts tested Name of Technician collecting the samples Date of next required certification Standards used to test room or equipment Comments indicating when dynamic operating conditions were used Notes Room sketch (location of supply/exhaust diffusers, equipment, room dimensions) Sketch identifying location of each sample obtained Total room area and volume Room humidity and temp Room air changes per hour Pressure differentials in water columns Nonviable particle counts (cfu s) Viable particle count analysis, action level for target ISO level Sketch of viable particle test location in room Certificates of analysis of media used Comments indicating when dynamic operating conditions were used A.3.3.8 Report Distribution The contractor will immediately notify the Contracting Officer s Representative (COR) with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 business days from certification evaluation. All completed reports will be provided via email to the COR. Contractor will be notified by the facility of any updates to identified points of contact list on an as needed basis. A3.3.9 Testing Frequency: Certification procedures for Pharmaceutical Compounding Areas defined in CETA CAG-003-2022 and other references CETA documents, shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months (+ or 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performedThis has been handled by using a trip fee from the contract and then PO for retesting work. . Environmental sampling (air and surface) will be completed semi-annually (every 6 months + or 20 days), or more frequently if required to assess corrective actions associated with prior negative results. An airflow smoke pattern test under dynamic operating conditions initially and every 6 months per USP 797. Environmental wipe sampling for hazardous drug residue will be performed every 6 months, Monthly surface sampling in areas where CSPs are prepared. Class II Biological Safety Cabinets will be certified semi-annually or annually per the equipment/task list. Replacement of cleanroom HVAC ceiling filters once every 5 years, including all room certification activities following the filter replacement(s) 2 hours of consulting time per year. A3.3.10 Additional trip charges Additional trip fees have been built into the contract to us if additional testing, troubleshooting, adjustment or repair is required. These additional site visits will only be utilized at the request of the COR. The additional site visit line item shall include all costs associated with travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay, or any other costs the contractor may incur in visiting the facility during and outside of the normal semi-annual visits. The cost must cover a site visit which may exceed a single workday (depending on the additional work required). A3.3.11 Test equipment and contractor standards All test equipment will be supplied by the contractor and must be calibrated within the last 12 months to an industry standard and manufacturer specifications. Calibration certification letters for equipment must be kept with the contractor technician for review by the VA COR at the time of inspection, if needed. All technicians performing the work must be qualified by education and experience. At least one technician performing the work in areas where CSPs are prepared must be CETA certified. Per VHA Directive 1108.12, all certification procedures defined in the applicable CETA Application Guides must be performed by a CETA National Board Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) individual or a vendor that employs at least one of these individuals initially and no less than every 6 months. Areas additionally must be recertified if there are any changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality. STATEMENT OF WORK PART B SUPPORTING INFORMATION B.1 Place of Performance and Logistics: The Iowa City VA Health Care System contains equipment and facilities for CSP at locations listed on the attached list. These locations are all in Iowa City on the hospital campus or nearby at the University of Iowa. The Contracting Officers Representative (COR) will be the primary contact for this contract. This person is the Facility Industrial Hygienist who is located in Bldg. 2, Room 203. They can be contacted at +1 (555) 000-0000 Extension 636805 to discuss certification/inspection inquiries. Inspections must be scheduled with the COR at least 2 weeks in advance. This is to notify all personnel using the equipment/facilities well in advance to allow their workflow to be adjusted and enable the equipment and/or rooms to be available for certification procedures. B.1.a Required Services and Equipment List. See attached excel spreadsheet for a detailed list of equipment and tasks included in this contract. This spreadsheet contains an overview of tasks with cost estimates, a detailed equipment/task list for Pharmacy/CSP areas, a detailed equipment list for non-pharmacy equipment, cost estimate for hazardous drug wipe sampling in all areas using or compounding hazardous drugs, a cost estimate and plan for monthly surface sampling for microbial and fungal contamination in CSP areas. Monthly surface sampling can be performed by in house pharmacy staff, but all supplies and lab services should be supplied by the contractor. Changes to facility equipment or tasks will be communicated in a timely manner to the contractor and facility costs will be adjusted accordingly based on these changes. The contractor is to provide unit-based costs for services to allow for adjustments in equipment and tasks. If the total quantity of any line item exceeds the cost allocated in the contract, a modification will be submitted. B.1.b Background check and badging requirements Language will be added to the contract that includes requirements for all personnel who come onsite to perform activities in this contract to complete background checks and receive a PIV badge. This badge must be worn at all times while on site. If the contractor works at multiple VA facilities, the background check and PIV badge issuance only needs to be done once. B.2 Period of Performance: Contract period is from date of award for five (5) years. Performance is to begin 15 calendar days from date of award. The contact is expected to start on November 1 to allow certification activities be done within the required time frame from the last certification. B.3 Special ConsiderationsWill language regarding badging be added to the contract so I don't have to include here? : B.3.1 Contractor Furnished Materials: All materials and tools to complete the work identified. Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments. B.3.2 Government Furnished Materials and Services: The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site. The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling. The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans. B.3.3 Qualifications/References: ICVAHCS is seeking a qualified contractor that meets the following specifications: Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center. Reference information is to include Hospital/Medical Center name, POC name, email address and phone number. All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility. All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. The CETA-certified technician must be onsite and working within the clean room areas while testing is being conducted. Supervision or oversight from a different location is not allowed. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility. Provide AIHA accredited laboratory certification for all USP<797> viable sampling analysis. Certification must be attached with bid documentation. Provide copy of clean room certification report for evaluation. Provide certification from accredited laboratory performing analysis of Hazardous Drug wipe samples. Contractor (employees performing services at the facility) will attain VA clearance and obtain a PIV identification card. After a review of the responses to this notice, a solicitation announcement may be posted to Contract Opportunities. A response to this notice is not an adequate reply to the forthcoming solicitation. Please fully complete each section of the survey below. Responses shall be emailed to Contract Specialist; Arielle Lifto, email address: contact@example.gov Company Name: _____________________________________________________________ Company Address: ___________________________________________________________ DUNS Number: _____________________________________________________________ Point of Contact: ____________________________________________________________ Phone Number: _____________________________________________________________ Email Address: _____________________________________________________________ Socio-economic Classification in Accordance with NAICS Code 541380: (check all that apply) Small Business Service Disabled Veteran Owned Small Business (SDVOSB) Verified SDVOSB by www.vip.vetbiz.gov Veteran Owned Small Business (VOSB) Verified VOSB by www.vip.vetbiz.gov Small Disadvantage Business Women-owned Small Business Economically Disadvantaged Small Business HUBZone 8(a) Certified Company s Capability Statement: __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. 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