Inactive

FUME HOOD TESTING AND CERTIFICATION SERVICE This is a Sources Sought Notice and not a solicitation announcement. The purpose of this Sources Sought Notice is to gain knowledge of qualified, potential ... FUME HOOD TESTING AND CERTIFICATION SERVICE This is a Sources Sought Notice and 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, Testing Laboratories. Responses will be used by the Government to make appropriate acquisition decisions. After a review of the responses to this Sources Sought Notice, a solicitation announcement may be posted. A response to this Sources Sought Notice is not an adequate reply to a potentially forthcoming solicitation. The Nebraska Western Iowa Health Care System (NWIHCS), Omaha NE, Grand Island NE, and Lincoln NE Medical Centers, located at 4101 Woolworth Ave, Omaha NE 68105 is seeking qualified potential contractors to provide Fume Hood Testing and Certification Services for all three medical center locations. The work consists of testing and certification of all the VA Nebraska Western Iowa (NWI) 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. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> and Chapter <800> guidelines. Standardizing testing criteria appropriate for all PECs will be pursuant to USP Chapter <797> and Chapter <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although USP <797> states that certification procedures such as those outlined CAG-003-2006 shall be performed, NWI will be requiring that CAG-003-2006 be used in lieu of any other such as procedures that may exist. 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 Draft Guidance on Insanitary Conditions at Compounding Facilities which was published in August 2016. Certification procedures defined in CETA CAG-003-2006 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. For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797>. Viable environmental (air and surface) sampling will be required every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. Service will include maintenance, recertification, and emergency repairs. Contract technicians shall be NSF Accredited Class II Biosafety Cabinet Field Certified. To respond to this Sources Sought Notice, please complete the attached form entitled Information and Capabilities and email the information requested to John Becker, Contracting Officer, at John.Becker3@va.gov. The closing date and time of this sources sought notice is March 5, 2020, 11:59 EST. Please complete the Attachment Information and Capabilities This is not a solicitation and in no way obligates the Government to award any contract. Additionally, a response to this Sources Sought Notice is not a request to be added to a prospective bidders list or to receive a copy of any forthcoming solicitation.