SOURCES SOUGHT
L -- ""NEW REQUIREMENT"" V5 Pharmacy Sterile Clean Certification
- Notice Date
- 5/10/2023 6:15:28 AM
- Notice Type
- Sources Sought
- NAICS
- 333413
— Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing
- Contracting Office
- 245-NETWORK CONTRACT OFFICE 5 (36C245) LINTHICUM MD 21090 USA
- ZIP Code
- 21090
- Solicitation Number
- 36C24523Q0622
- Response Due
- 5/17/2023 12:00:00 PM
- Archive Date
- 06/16/2023
- Point of Contact
- mark.smith25@va.gov, Mark Smith, Phone: 410-642-2411
- E-Mail Address
-
Mark.Smith25@va.gov
(Mark.Smith25@va.gov)
- Awardee
- null
- Description
- Page 16 of 16 RFI SOURCES SOUGHT DISCLAIMER: This Sources Sought is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this Sources Sought. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the Sources Sought will not be returned. At this time, questions concerning the composition and requirements for a future Request for Quote will not be entertained. The Department of Veterans Affairs is conducting market research in order to provide Testing and Certifications VISN 5. The Government anticipates awarding a Firm Fixed Price type contract that will provide the Testing and Certifications listed within the below Draft Statement of Work. OBJECTIVE: See Draft SOW. RESPONSE INSTRUCTIONS: Name and Address of Company Any small business designation as certified by the Small Business Administration A through description of experience in managing support requirements of this nature. CONTACT INFORMATION: Any questions related to this Sources Sought shall be directed to Mark Smith at Mark.Smith25@va.gov. All information regarding Capabilities Statements or any other proprietary information relative to this Sources Sought shall be submitted via email to Mark.Smith25@va.gov no later than 3:00 PM EST on 05/17/2023. DESCRIPTION / SPECIFICATION / WORK STATEMENT STATEMENT OF WORK PART A GENERAL INFORMATION A.1 INTRODUCTION: This requirement is for testing and certification of all the VISN 5 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 5 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. 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 5 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 are identified during certification visit, and within contractor ability to resolve which may include, but are not limited to: PEC Chemo Decontamination LAFW filter or blower replacement BSC filter or blower replacement Repairs may include parts if agreed upon by facility prior to installation. A.3.5.8 Report Requirements All of the following information should be included in the report for clean room certification. Pass/Fail notifications (in addition to actual findings) should be included on a per-test basis where applicable. Executive summary or summary of findings Recommendations to resolve any identified discrepancies Room number and/or location Room type (e.g., oncology prep room) Date of testing Date of next required certification Standards used to test room Notes Room sketch (location of supply/exhaust diffusers, equipment, room dimensions) Total room area and volume Humidity and Temperature of each room assessed for certification Air changes per hour with assessment based both from USP standards as well as those referenced within the VHA HVAC Design Manual Pressure differential Particle Count Tests Nonviable particle counts Viable particle count analysis Picture of viable particle test location in room Number of personnel present in each PEC and SEC during total particle-count tests Environmental viable sample results Environmental Wipe Sampling for Hazardous Drug Residue results Dynamic Airflow Smoke-Pattern Test Results Smoke test video (either embedded in report, or a link to the video) Number of personnel present in each PEC and SEC Confirm/distinguish dynamic and static conditions if applicable Note: All PECs shall follow report requirements for a non-USP units but shall include viable and nonviable particle sampling. A.3.5.9 Report Distribution The contractor will immediately notify identified points of contact 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 days from certification evaluation. All completed reports will be provided via email tovisn5cspadvisorycommittee@va.gov. In addition, facility specific reports will be provided to the following points of contact: Baltimore VAMC: Christopher Maltese (Christopher.Maltese@va.gov) Shawnol Jemison (Shawnol.Jemison@va.gov) Eugene DeLara (Eugene.DeLara@va.gov) Ron Lilly (Ronald.Lilly@va.gov) Robert Johnson (Robert.Johnson5@va.gov) Bill Mytsak (Vasyl.Mytsak@va.gov) Perry Point VAMC: Christopher Maltese (Christopher.Maltese@va.gov) Eugene DeLara (Eugene.DeLara@va.gov) Ifeanyi Anadu (Ifeanyi.Anadu@va.gov) Robert Johnson (Robert.Johnson5@va.gov) Bill Mytsak (Vasyl.Mytsak@va.gov) Loch Raven VAMC: Christopher Maltese (Christopher.Maltese@va.gov) Eugene DeLara (Eugene.DeLara@va.gov) Frederick Soetje (Frederick.Soetje@va.gov) Robert Johnson (Robert.Johnson5@va.gov) Beckley VAMC: Jack Wright (Jack.Wright2@va.gov) Brianne Fairchild (Brianne.Fairchild@va.gov) Austin Lilly (Austin.Lilly@va.gov) Lawrence Woods (Lawrence.Woods@va.gov) Justin Greene (justin.greene@va.gov) John Montgomery (John.Montgomery3@va.gov) Louis A. Johnson (Clarksburg) VAMC: Carissa Bartlett (Carissa.Bartlett@va.gov) Angela Dawkins (Angela.Dawkins@va.gov) Barbie Covelli (Barbara.Covelli@va.gov) Dan Young (Daniel.Young@va.gov) Amy Gay (Amy.Gay@va.gov) Alyssa Green (Alyssa.Green@va.gov) Huntington VAMC: Joey Nash (William.Nash4@va.gov) Chris Waugh (Chris.Waugh@va.gov) Charles Alex Noble (Charles.Noble@va.gov) Dan Nicholson (Daniel.Nicholson@va.gov) Eli Gillespie (Eli.Gillispie@va.gov) Jamie Farley (Jamie.Farley@va.gov) John Klim (John.Klim2@va.gov) Martinsburg VAMC: David Everhart (David.Everhart@va.gov) Denise Canby (Denise.Canby@va.gov) Sarah Mickanis (Sarah.Mickanis@va.gov) Krista Bowen (Krista.Bowen@va.gov) Jeff Miller (Jeffrey.Miller6@va.gov) Andrew Faust (Andrew.Faust@va.gov) Washington DC VAMC: Isaac Buabeng (Isaac.Buabeng@va.gov) Ivan Cephas (Ivan.Cephas@va.gov) Mitiku Berhanu (Mitiku.Berhanu@va.gov) Berook Addisu (Berook.Addisu@va.gov) William T. Hagen (William.Hagen@va.gov) Contractor will be notified by facility of any updates to identified points of contact list on an as needed basis. Within the first 10 calendar days of each quarter, the contractor will provide via email to visn5cspadvisorycommittee@va.gov a schedule of pending visits for the quarter per site including scheduled dates and planned tests (i.e. semi-annual certification, re-certification, viable sampling, etc.) Testing Frequency: Certification procedures defined in CETA CAG-003 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. Environmental sampling (air and surface) will be completed quarterly (every 3 months), or more frequently if required to assess corrective actions associated with prior negative results. Government captured surface samples will be completed each month between contractor captured results. Recertification procedures may be required in between scheduled semi-annual certifications based upon certification findings which may include any applicable certification test or environmental sampling. Recertification visits will be scheduled and completed within 2 weeks of request from the facility. Environmental wipe sampling for hazardous drug residue will be performed every 6 months, or more frequently if required to verify containment. STATEMENT OF WORK PART C SUPPORTING INFORMATION C.1 Place of Performance: Facility Name Address Baltimore VAMC 10 North Greene Street, Baltimore, MD 21201 Perry Point VAMC VA Medical Center, Perry Point, MD 21902 Loch Raven VAMC 3900 Loch Raven Blvd, Baltimore, MD 21218 Beckley VAMC 200 Veterans Avenue, Beckley, WV 25801 Louis A. Johnson (Clarksburg) VAMC 1 Medical Center Drive, Clarksburg, WV 26301 Hershel Woody Williams (Huntington) VAMC 1540 Spring Valley Dr., Huntington, WV 25704 Martinsburg VAMC 510 Butler Avenue, Martinsburg, WV 25405 Washington DC VAMC 50 Irving St. NW Washington DC 20422 Specific PEC and Clean Room Information Per Site: Baltimore VAMC: Hood Baltimore VAMC 1 2 3 Physical Location (Building #) BA121K BA121K BA121L Manufacturer Baker NuAire Baker Model Number EG-6252 NU-407-400 SG400 Serial Number 90751 68736ADU 60541 Make LFU Class II Type A/B3 Class II Type A/B3 EE# EE81086 EE41397 EE46875 Clean Rooms: Cleanroom Suite: Anteroom (ISO 7) Non-Hazardous IV Prep (Buffer) Room (ISO 7) Hazardous IV Prep (Buffer) Room (ISO 7) HEPA Filter Information: Quantity: 8 Total HEPA Filters (7 Supply and 1 exhaust) Location(s) 7 Ceiling Supply Diffusers 1 Above Ceiling not in interstitial space Test Port Status: installed by Winergy circa 2018/2019 and are functional. Perry Point VAMC: Hood New hood purchased and enroute to site Perry Point VAMC CAI Physical Location (Building 361) GC108B Manufacturer Baker Model Number SS500 Serial Number Unknown currently Make Class 5 CAI EE# Not onsite yet Clean Rooms: Segregated Compounding Area CAI certification only. HEPA Filter Information: Quantity: N/A - SCA Location(s) N/A - SCA Test Port Status: N/A - SCA Loch Raven VAMC: (under construction with completion tentative for April 2023) Hood Hood Loch Raven VAMC CAI CACI Physical Location (Loch Raven Campus) TBD TBD Manufacturer Baker Baker Model Number SS500 CS600 Serial Number TBD TBD Make class 5 CAI Class 5 CAI EE# Not onsite yet Not onsite yet Clean Rooms: Segregated Compounding Area CAI certification only. Containment Segregated Compounding Area CACI certification only. HEPA Filter Information: Quantity: N/A - SCA Location(s) N/A - SCA Test Port Status: N/A - SCA Beckley VAMC Hood Beckley VAMC IVPB CHEMO LAFW BSC Cleanroom Pass Through Physical Location (Building #) 1AB-108B-B 1AB-108B-C Manufacturer LABCONO NUAIRE BAKER NuAire Terra Universal Model Number 36100000 NU-430-600 EG4320-19930 NU-543-410UB00 2634-80A Serial Number 08283192 P 123452052208 140856 212883040722 2634-80A-P173983 Make Class II Type A2 Class II Type A2 EE# EE13673 EE13921 Clean Rooms: Cleanroom Suite: Anteroom (ISO 8) Non-Hazardous IV Prep (Buffer) Room (ISO 7) Hazardous IV Prep (Buffer) Room (ISO 7) HEPA Filter Information: Quantity: Nine (9) 2x4 filters Location(s) 3 Diffusers in Room 4AB-110 Anteroom; 3 Diffusers in Room 4AB-110B IV Compounding; 3 Diffusers in Room 4AB-110C Chemo Compounding Test Port Status: Available Louis A. Johnson (Clarksburg) VAMC Hood Louis A. Johnson (Clarksburg) VAMC Chemo BSC 1 BSC 2 Physical Location (Building #) Clinical Addition B215G-1 Clinical Addition B215F-1 Clinical Addition B215F-1 Manufacturer LabConco LabConco LabConco Model Number 3441000 346100 346100 Serial Number 091118151B 091118140B 091118141B Make 4' purifier biosafety cabinet Class II Type B2 6' purifier biosafety cabinet Class II Type B2 6' purifier biosafety cabinet Class II Type B2 EE# EE17187 EE17188 EE17189 Clean Rooms: Cleanroom Suite: Non-Hazardous Anteroom (ISO 8) Non-Hazardous IV Prep (Buffer) Room (ISO 7) Hazardous Anteroom (ISO 7) Hazardous IV Prep (Buffer) Room (ISO 7) Hazardous Drug Storage HEPA Filter Information: Quantity: 13 HEPA Filters (ceiling supply) Location(s) 3 Anteroom 8 Non-HD Buffer Room 2 HD Buffer Room Test Port Status: Unknown Huntington VAMC Hood Huntington VAMC LAFW LAFW BSC CACI Physical Location (Building #) 1B101a 1B101a 1B101b Research Building Room 101 Manufacturer Baker Baker Nu-Aire Nu-Aire Model Number EG-4252 EG-6252 NU-430-600 NU-NR800-400 Serial Number 109952 107979 153119100912 206990071221 Make EdgeGARD EdgeGARD LabGard ES FlowGard EE# 37066 35809 35769 59777 Clean Rooms: Cleanroom Suite: (Pending Construction Completion-TBD) Non-Hazardous Anteroom (ISO 8) Non-Hazardous IV Prep (Buffer) Room (ISO 7) Hazardous Anteroom (ISO 7) Hazardous IV Prep (Buffer) Room (ISO 7) SCA Hazardous IV SCA Room HEPA Filter Information: Quantity: 3 HEPA Filters Location(s) 2 located in air handling above ceiling in ante room 1 filter located in air handler above break room table Test Port Status: Unknown Martinsburg VAMC Clean Rooms: Cleanroom Suite: Non-Hazardous Anteroom (ISO 8) Non-Hazardous IV Prep (Buffer) Room (ISO 7) Hazardous Anteroom (ISO 7) Hazardous IV Prep (Buffer) Room (ISO 7) HEPA Filter Information: Washington DC VAMC WASHINGTON DC VAMC HOOD INVENTORY LAFT LAFT BSC BSC IVPB ISOLATOR CHEMO ISOLATOR Physical Location 1E-141 1E-141 1E-144 1E-144 4E-122 4E-124 Manufacturer BAKER BAKER BAKER BAKER NUAIRE NUAIRE Model Number EG-6252 EG-6252 SG604 SG604 NU-PR797-600 NU-NR797-600 Serial Number 131988 131987 131989 131990 1.43161E+11 1.42613E+11 Make EdgeGARD® HF Clean Benches EdgeGARD® HF Clean Benches Class II, Type A2 Class II, Type A2 CAI CACI EE# NA NA NA NA EE1288022 EE1292025 Clean Rooms: Cleanroom Suite: Anteroom: ISO 7 Non-Hazardous IV Prep (Buffer) Room (ISO 7) Hazardous IV Prep (Buffer) Room (ISO 7) Segregated Compounding Area IVPB Isolator (CAI) Chemo Isolator (CACI) HEPA Filter Information: Quantity: 5 Total HEPA Filters Location(s) 5 filters within ceiling supply diffuser Test Port Status: 5 test ports Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit-based costs for services to allow for adjustments in equipment. C.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. C.3 Special Considerations: C.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. C.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. The Government will provide replacement HEPA filters, when applicable. May also provide desk phone service as needed. C.3.3 Qualifications of Key Personnel: VISN 5 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. 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. 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 viable sampling analysis. Certification must be attached with bid documentation. Provide copy of clean room certification report for evaluation. C.3.4 Security Requirements: There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return. C.3.5 Additional Considerations The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility ...
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