- Country: USA
- Summary: 36C249-27-AP-0005 - Sterile Compounding Certification - (TVHS Pharmacy)
- UST Ref No: 123319416
- Deadline: 01 Aug 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 36C24925Q0381
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- Description:
- Description
TVHS VAMC Pharmacy ServiceStatement of WorkSterile Compounding Bi-annual Certification, Monthly Viable Testing, and Personnel Gloved Fingertip and Media Fill TestingBACKGROUND: The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of Compounded Sterile Preparations (CSPs). The Joint Commission (TJC) established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. Additionally, the Food and Drug Administration (FDA) has the authority to inspect VA medical facilities. VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated November 1, 2023, defines organizational responsibility for USP standards for cleanroom design and engineering controls and environmental monitoring and biannual certification of these areas. It is VHA policy that each VA medical facility that provides CSPs have a pharmaceutical CSP program in place that conforms to the standards in USP Chapter Pharmaceutical Compounding Sterile Compounding Sterile Preparations USP Chapter standards require successful biannual certification of the areas and equipment and monthly environmental testing of the same and Chapter USP requires further testing of hazardous drug areas. In addition, USP Chapter requires biannual gloved fingertip and media fill testing of all compounding personnel. OBJECTIVE: VA Tennessee Valley Healthcare System (TVHS) seeks a contract for biannual certification, monthly viable surface and air testing, and personnel required testing. All testing must be in accordance with all applicable USP Chapter and USP Chapter standards, VHA Directive, medical center policies, standard operating procedures, and Controlled Environment Testing Association (CETA) guides. SCOPE OF WORKBi-annual Certification: All primary and secondary engineering controls (SEC... - Documents:
Sterilgard-BSC-Operating-Manual.pdf
Wage-Determination-No-2015-4647-Revision-29.docx
LIMITATIONS-ON-SUBCONTRACTING-CERTIFICATE-OF-COMPL.docx
Murfreesboro-Sterile-Compounding-Area.pdf
Nashville-Sterile-Compounding-Area.pdf
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CLICK HERE TO LOGIN36C249-27-AP-0005 - Sterile Compounding Certification - (TVHS Pharmacy) - USA Tender
The VETERANS AFFAIRS, DEPARTMENT OF, a Government sector organization in USA, has announced a new tender for 36C249-27-AP-0005 - Sterile Compounding Certification - (TVHS Pharmacy). This tender is published on USARFP under UST Ref No: 123319416 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-08-01.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
