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SAMDAILY.US - ISSUE OF JANUARY 09, 2020 SAM #6615
SOLICITATION NOTICE

H -- SOLICITATION | 618-20-1-109-0213 | Certification of sterile IV compounding hoods/rooms - Mpls

Notice Date
1/7/2020 11:35:38 AM
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
621511 — Medical Laboratories
 
Contracting Office
263-NETWORK CONTRACT OFFICE 23 (36C263) MINNEAPOLIS MN 55417 USA
 
ZIP Code
55417
 
Solicitation Number
36C26320Q0156
 
Response Due
1/8/2020 8:59:59 PM
 
Archive Date
02/07/2020
 
Point of Contact
David A RaadContract Specialist605-347-2511 x6851
 
E-Mail Address
David.Raad@va.gov
(David.Raad@va.gov)
 
Small Business Set-Aside
SBA Total Small Business Set-Aside (FAR 19.5)
 
Awardee
null
 
Description
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 and 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 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 Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although USP 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 The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the Draft Guidance on Insanitary Conditions at Compounding Facilities which was published in August 2016.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.
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/108c7ce4a8934d46967868219569aa20/view)
 
Record
SN05527955-F 20200109/200107230129 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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