RFQ - Biological Safety Cabinets Inspect/Certification Laboratory Hoods & Pharmacy Clean/Ante Room

Inspection & Certification of Biological Safety Cabinets, Laboratory Hoods & Pharmacy Clean/Ante Rooms and Specialized Room Ventilation Systems Oklahoma City VA Medical Center BRIEF SCOPE OF WORK (This is for information only) 1. PURPOSE 1.1 The contractor shall provide testing and certification of specialized room ventilation systems, chemical hoods, Laminar Flow Workstations (LFWs) and Biological Safety Cabinets (BSCs) to provide a safe environment for laboratory personnel at Oklahoma City VA Health Care System. in accordance with this PWS, in an efficient and cost-effective manner, supporting the VA mission. This is a non-personal services contract. The Contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose of fulfilling the PWS and shall be considered employees of the Contractor. Contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, insurances, licenses, certifications and supervision necessary to provide services in accordance with this Performance Work Statement (PWS). 2. SCOPE 2.1 Contractor shall furnish service as specified below to ensure that the equipment functions in accordance with: A. NCI Specification General Purpose, Clean Air, Biological Safety Cabinet, revised August 19, 1975 , A. NIH specification NIH-03-11ZC dated Sept 17, 1974. A. National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49 [NSF 49]. A. Federal Standard No. 209E-April 24, 1973, Clean Room and Workstation Requirements, Controlled Environment . A. SAMA Standard LF10-1980 Laboratory Fume Hoods and USP 797/USP 795 A. USP General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings 2017 A. CAG-002-2006 A. CAG-003-2006 A. CAG-007-2010 A. CAG-008-2010 A. IEST RP-CC-034 A. CETA Compounding Testing Guide 2006 A. FDA Insanitary conditions for Compounding A. CETA Viable Sampling SOP A. CETA Certification Guide May 2015 2.2 Furnish all labor, equipment, tools, materials, and travel necessary to test, certify and measure Government owned Biological Safety Cabinets (BSCs), Laminar Flow Work Stations (LFWs), and Pharmacy clean rooms 2.3 Equipment and locations are identified on the Schedule of Items. 2.4 The annual/semi-annual certifications shall be performed in sufficient time to ensure that none shall lapse (contractor will schedule testing that builds in time for repairs should that be necessary to ensure certifications never lapse). With two lab hoods in Chemo and two hoods in IV mixing areas. Lab hoods are to be staggered for certification with two hoods certified in the months of December/June and the other two hoods certified during the months of March and September each year. Research provides backup bariatric hoods for mixing chemo and IV s and these hoods are certified during the months of March/September. 2.5 The Contractor shall provide certification reports upon completion of semi-annual and annual testing/certification. Report will include training/certifications of technicians performing the work and calibration certificates of the equipment used during the testing/certification. 2.6 Contractor will immediately notify COR in writing (letter) or by email, in the event any/all regulatory guidance governing the certifications of any subject equipment changes. Written advisement will include any issues which will impact testing/certification. Contractor will also advise Oklahoma City VA Medical Center of recommendations to resolve any issues related to the regulatory changes. 2.7 When testing/servicing/certifying equipment, the Contractor will provide on-site consultation to Oklahoma City VA staff (answer questions, make recommendations to maintain at optimum level) that use the Pharmacy cleanroom, the biosafety cabinets, and the laminar flow workstations. Technicians knowledgeable about certification requirements will converse with staff/COR to inform them of recommended adjustments to behaviors used in daily use, cleaning of area, maintenance of equipment, and any structural/HVAC/electrical/engineering issues related to the equipment or rooms encompassing equipment. Technicians will brief COR of any issues/questions raised by staff upon checking out post-certification. 2.8 Contractor shall have the capability to respond within 24 hours of contact for emergency repair. Contractor shall furnish the Contracting Officer Representative (COR) with written estimate of cost to make necessary repairs and receive COR approval prior to initiating repairs. 2.9 All of the following information should be included in the report for clean room certification. 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, Room sketch, Total room area and volume, Room humidity and temperature, Air changes per hour, Pressure differential, non-viable particle counts, and viable particle count analysis. Pass/Fail notifications should be included on a per test basis where applicable. 3. CERTIFICATION AND TESTING REQUIREMENTS 3.1. Biological Safety Cabinets (BSC): The Pharmacy biosafety cabinet shall be certified semi-annually. All other Biosafety cabinets will be certified annually. Certification shall consist of the following: A. Down flow velocity test A. Inflow velocity test A. Airflow smoke pattern test (videotaping must be included for Pharmacy hoods only) A. HEPA filter leak test A. Alarm function test A. Blower interlock test (Class II, type B cabinets) A. Electrical leakage on the main cabinet (those that aren t UL listed) A. Ground Fault Circuit Interrupter (GFCI) outlet trip test. A. A visual inspection to identify defects, damage, misuse or missing parts A. Documentation of the certification and inspection results A. A decal or label affixed to the cabinet in a visible location that indicates the results and date of the certification A. Posting an Out of Service sign on cabinets that fail certification. A. Notifying the cabinet user and the COR of cabinets that fail certification. 3.2 Laminar Airflow Workstations (LAFW): All LAFWs will be certified annually. Certification shall consist of the following: A. Measurement of sash face velocity according to the current version of ASHRAE 110. A. Comparison of the sash face velocity to the current ACGIH recommendation. A. Airflow smoke pattern test. A. GFCI outlet trip test. A. A visual inspection to identify defects, damage, misuse or missing parts. A. Documentation of the certification and inspection results (e.g., a decal or label affixed in a visible location that indicates the sash certification height, the face velocity and the date of certification). A. Posting an Out of Service sign on lab fume hoods that fail certification. A. Notifying the lab fume hood user and the COR of lab fume hoods that fail certification. 3.3 Pharmacy Cleanroom(s) Testing and Certification: Testing and certification (under CAG-003-2006-11 and to USP797 Standards and 800 Hazardous Drugs Handling in Healthcare Settings.) of the Pharmacy: Ante Room, Hazardous Buffer (IV) Room and Non-Hazardous Buffer (Chemo) Room as well as viable air and surface sampling for mold and bacteria will be semi-annually. Certification and testing shall consist of the following: A. Test and validate the number of air changes per hour (ACH) through the rooms Heating Ventilation and Air Conditioning (HVAC) equipment and exhaust hood. A. Pressure Requirements: The contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas A. Non-viable Particle Testing: The contractor shall perform environmental nonviable particle testing semiannually A. Test and validate that the hood and room exhaust provide a unidirectional/laminar flow of air. A. Inspect HVAC filter assembly for air bypass issues. A. Test and calibrate the existing air balancing monitors (Chemo and Ante Rooms). A. Take viable air samples for mold and bacteria (1 location in each PEC: LFWs, BSC, Pass Thru, and 1 location in the room Ante, and 2 locations Chemo and IV Room. Colony forming units (CFU) results from the cultures shall be calculated in cfu per cubic meter (m3) of air. A. Take viable surface samples for bacteria (1 each in LFWs, BSC, Pass Thru, Ante, Chemo and IV Room. 4. PERSONNEL ACCREDITATION REQUIREMENTS 4.1 Contractor services personnel must be NSF accredited and submit their NSF accreditation certificates with their bid proposal. 4.2 Technician performing on-site testing for Pharmacy must be CETA certified. 5. PERIOD OF PERFORMANCE AND WORK HOURS 5.1 The period of performance shall be for one base year with four possible one-year option periods (as outlined with the schedule / line items). 5.2 The Contractor (or Representative) shall contact the COR, Contracting Officer s Representative, to schedule work and prior to the beginning of work. 5.3 Services are to be performed during our business hours between 7:30 a.m. and 4:00 p.m. central time, excluding federal holidays. Because of the workload of the pharmacy during business hours, the contractor may need to work after 4:00 p.m. in order to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00 p.m. this service must be included within the bid pricing as no extra charge will be allowed. The ability to perform work after hours is not required. however, preference will be given to contractors that offer flexible work hours. 6. INSPECTION AND ACCEPTANCE: 6.1 The Contractor shall conduct a joint inspection with the COR upon certification and testing of equipment. 7. DELIVERABLES 7.1 After work is completed, the contractor is to submit in writing, a complete report of services performed for each item of equipment and must include a listing of replacement parts, when applicable. Within one week of obtaining sampling results, the vendor will electronically report ventilation and sampling data semiannually to Oklahoma City VA Medical Center Safety Management has a means of evaluating the overall control of the compounding environment. The report should have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination. 7.2 The contractor shall supply every unit that passes required certification specifications with a certification sticker. 8. TRAINING 8.1 No training is required from the contractor. 9. Transportation Visits = 6 visits a year (4 required and 2 additional trips for troubleshooting/retesting etc.) 10. Facility Information Security Officer (FISO) SECURITY LANGUAGE: 10.1 GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Pharmacy Testing BioSafety/Laminair hood/cabinet testing/inspection/certification BSC Cabinets 5 BSC cabinets 4 rooms Semi-annual testing Laminar hoods 4 hoods 2 rooms Semi-annual testing Research GR-102 1 hood 1 room Semi-annual testing Path lab Testing 4F115 Microbiology Nuaire 1 hood annual testing 4F115C1 Microbiology Nuaire 1 hood annual testing 4F115 B Microbiology Nuaire 1 hood annual testing 4F133 Cytology Nuaire 1 hood annual testing 4F137 Molecular Nuaire 1 hood annual testing 4F105 Hematology Nuaire 2 hoods annual testing Sputum Booth 1A105J Aero med 1 booth annual testing Isolation Rooms (Ceiling HEPA filter) 5F116 annual inspection/testing 5F144 annual inspection/testing BF132 annual inspection/testing BF133 annual inspection/testing IMPORTANTR NOTE: This Sources Sought is for information only (to determine the socioeconomic status of interested companies). No award will be made off of this posting. LIMITATIONS OF SUBCONTRACTING: The Limitations of Subcontracting may or may not apply to a resulting solicitation from this Market Research. Vendors are advised to familiarize themselves with Federal Acquisition Regulation parts 19.505(a)(2) and 19.505(b)(1) as it pertains to subcontracting limitations. Vendors are also advised to familiarize themselves with 13 CFR 125.6 and the penalties described in this regulation. Please communicate via e-mail to jeffery.eller@va.gov by COB 11/23/2022 as to your company s interest and ability to perform service per this brief Scope of Work. If interested, please provide the following: Please state your company s business size as related to NAICS code XXXXXX As per the Limitations of Subcontracting: (see FAR 19.505) As Primary Contractor: what % of Total Contract Value will you retain If using a Subcontractor: what % of Total Contract Value will go to them Please provide SAMs Unique Entity Identifier number If you have an FSS/GSA contract that includes this service Provide FSS/GSA contract number if applicable *****NOTE*****According to 2022 North American Industry Classification System 811219 is being replaced with 811210. Please update this information in SAM.gov. The method of contractor selection has not been determined at this time.

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