36C26320Q0156-000.docx

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice H SOLICITATION | 618-20-1-109-0213 | Certification of sterile IV compounding hoods/rooms - Mpls 57741 36C26320Q0156 01-08-2020 N

SBA

621511 Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 113 Comanche Rd.

Fort Meade SD 57741

STATEMENT OF WORK PART A – GENERAL INFORMATION

A.1 INTRODUCTION: This requirement is for testing and certification of the Minneapolis VAHCS facility’s primary engineering controls (PECs) and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs) and laminar airflow workstations (LAFWs) hoods., Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> and <800> guidelines. Maintenance and repair services of BSCS and LAFWs are required by this contract.

A.2 BACKGROUND: The Minneapolis VA Healthcare System is pursuing a contract for standardizing testing criteria appropriate for all PECs used 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, the Minneapolis VA 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 The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the Draft Guidance on “Insanitary Conditions at Compounding Facilities” which was published in August 2016.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 Pharmacy PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.