Q301--Pharmacy Biannual Employee Competency Base+ 4 OY (Compounding Sterile Preparations)

INTENT TO SOLE SOURCE GENERAL INFORMATION Network Contracting Office (NCO) 22 Attn: Barry Bland Department of Veteran Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach, CA 90815 +1 (555) 000-0000 Intent to Sole Source: The Government intends to make a sole award firm-fixed-price contract in accordance with Federal Acquisition Regulations (FAR) 6.302-2 Only One Source in conjunction with FAR 13.5 Simplified Procedures for Certain Commercial Items. The requirement is for pharmacy biannual employee competency testing for compounding sterile preparations. VASDHCS at 3350 La Jolla Village Drive, San Diego, CA 92161 is a 296-bed hospital from the Desert Pacific Healthcare Network (VISN 22) that provides various medical services to our veteran population. During a patient s hospital stay, inpatient pharmacy service is responsible for preparing and delivering drugs for the patient s treatment. VASDHCS follows the USP 797 standards (a guideline established by the United States Pharmacopoeia (USP) for all facilities that compound to meet minimum practice and quality standards) when compounding sterile preparations. USP 797 requirements are followed to minimize harm or death to humans which could result from 1) microbial contamination, 2) excessive bacterial endotoxins, 3) variability from the intended strength of correct ingredients, 4) physical and chemical incompatibilities, 5) chemical and physical contaminants, and/or 6) use of ingredients of inappropriate quality. One of the requirements from USP 797 is employee competency to assess that all compounding personnel have proper aseptic technique (demonstrated through media fill test) and are competent in garbing and hand hygiene (demonstrated through gloved fingertip test). In the past, USP 797 only required annual employee competency with media fill test and gloved fingertip test. The updated USP 797 released in November 2022 now requires all compounding facilities to complete biannual employee competency with the added requirement of environmental testing post media fill and gloved fingertip test. Environmental testing involves surface sampling of the direct compounding area, incubation of the surface sample plates, and genus identification for any growth detected. Currently, all employee competency is conducted in house and collected samples are sent to the microbiology lab for processing at our facility. With this new USP 797 requirement in place, our microbiology lab is unable to take on this extra workload for multiple reasons. Our microbiology lab does not have the certifications required for environmental testing and do not have the space available to incubate extra media plates. Additionally, per USP 797, if any growth is detected in the surface sample, genus identification is required, which our facility s microbiology lab is also not equipped with machines needed for processing samples. Performing and completing biannual competency for all staff that is involved in compounding sterile preparations is imperative to hospital operations and patient care. This contract must be fulfilled for compliance to USP 797 requirements and the Joint Commission. The intended source is VA San Diego Healthcare Systems. In accordance with FAR Part 6, contracts awarded using this authority shall be supported by a written justification and approval described in FAR 6.303 and 6.304; as applicable, the justification will be posted within fourteen (14) days after contract award. The Government will consider all capability statements received by this synopsis's closing date. The Government's determination not to compete based on responses to this notice is solely within the Government's discretion. Information received will be considered strictly to determine whether to conduct a competitive procurement. The applicable North American Industrial Classification System Code (NAICS) code that this work falls under is 541380 - Testing Laboratories, with a size standard of $10 million. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. All capable sources must provide past performance experience in similar research services and be a licensed provider (whichever applies to the requirement). All vendors must be registered in Beta. SAM by the close of this notice, and if your firm is a Service-Disabled Veteran- Owned or Veteran-Owned Small Business, you must be CERTIFIED in VetCert (see internet site: Veteran Small Business Certification (sba.gov.)). Proof of licenses must be submitted with supporting evidence. All the above information should be included in the vendors' capability in response to this notice. All inquiries and submittals must be sent via email to contact@example.gov no later than 15:00 PM Pacific Time (PT), 11/24/2023. Please ensure that notice # 36C26224Q0251 is cited on all submitted documents to ensure that it is appropriately processed.