Inactive
Notice ID:36C24625Q0030
Sources Sought Only: This is not a request for bids, quotes, or proposals. This is a Sources Sought notice for the identification of potential vendors capable of performing United States Pharmacopeia ...
Sources Sought Only: This is not a request for bids, quotes, or proposals. This is a Sources Sought notice for the identification of potential vendors capable of performing United States Pharmacopeia (USP) chapter <797> mandatory competency/environmental testing for pharmacy sterile compounding services for the Durham VA Healthcare System (VAHCS) located at 508 Fulton Street, Durham, NC 27705 and Greenville HCC located at 401 Moye Blvd. Greenville, NC 27834 This request is solely for the purpose of conducting market research to enhance VHA s understanding of your company s offered services and capabilities. The Government will not pay any costs for responses submitted in response to this Source Sought Notice. This Sources Sought notice provides an opportunity for respondents to submit their capability and availability to provide the service requirement described below. Vendors are being invited to submit information relative to their potential to fulfill this requirement, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. Potential vendors should be capable of supplying the following: Performing United States Pharmacopeia (USP) chapter <797> mandatory competency/environmental testing for pharmacy sterile compounding services. The Durham VAHCS and Greenville HCC seeks an accredited clinical lab to perform the analysis, incubation and sending the results of compounding personnel competencies and environmental testing done in the sterile compounding areas. Those tests are required to comply with USP<797> 2022 version standards and VHA Directive 11108.12, Management and monitoring of pharmaceutical compounded sterile preparations dated November 5, 2018. Currently, Durham VAHCS and Greenville HCC clinical lab does not have International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certifications to perform those testing and 90% of VHA facilities send this testing to a certified lab external to their facility. General requirements: Incubation and analysis of the media plates used for monthly surface sampling in pharmacy sterile compounding areas. Incubation and analysis of media bags, media plates, media paddles used for initial and ongoing competency testing required for sterile compounding personnel. Sending the analysis results to the pharmacy in a timely manner. Special Requirements: Incubation Temperatures and Timeframes: Competency Media 1st Incubation 2nd Incubation Total Incubation Timeframe Gloved fingertip and surface samples TSA agar plate, paddle or slide with polysorbate 80 & lecithin (neutralizers) > 48 hours at 30°C - 35°C > 5 Days at 20°C - 25°C > 7 Days Media fill test final dose unit(s) Soybean casein digest (all components) 7 Days at 20°C - 25°C 7 Days at 30°C - 35°C 14 Days Contractor (Lab) requirements: Qualifications/Certifications: Per the Memorandum dated October 24th,2023 from the Assistant Under Secretary for Health for Clinical Services/Chief Medical Officer: The clinical lab must have an ISO/IEC 17025 certification from an external accrediting body (e.g., American Association for Laboratory Accreditation) to ensure quality and accuracy of the testing. The clinical lab must perform their analysis and incubation per USP<797> 2022 version standards. Interested and capable respondents are requested to provide the information below. Company name, address, point of contact, phone number, SAMs UEI number List of available products or services, and business size (small or large business concern). Failure to provide the above information may result in the potential offeror being considered incapable of meeting the VA s needs. Again, all respondents shall submit capability statement signifying that they meet the above-mentioned specifications. The capability statements received from this market research survey are for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research, and the Government will not entertain questions concerning this market research survey. The Government will not assume any costs incurred by the contractor in the preparation of responses. All responses shall be submitted in the form of email to Cherisse.Hall@va.gov Please reference 36C24625Q0030 United States Pharmacopeia in subject line. Telephone responses will not be accepted. Responses must be received in writing no later than 4:30pm EST on September 12, 2024. All contractors interested in doing business with the Government must be registered in the System for Award Management (SAM) database. The website for registration is www.sam.gov. Service-Disabled Veteran-Owned Small Businesses and Veteran-Owned Small Businesses should also indicate whether the company is verified by SBA on VetCert Database at Veteran Small Business Certification (sba.gov). Please do not include any quotes. This notice is to assist the VA in determining sources only.
