Pharmacy Compounded Sterile Preparation (CSP) VISN 15

The Performance Risk Assessment Questionnaire is a critical tool for federal government RFPs, specifically for Compounding Services, requiring offerors to provide a minimum of three current/past performance references from the last three years. References must submit questionnaires directly to the Contract Specialist via email, not through the offeror, by the solicitation's due date. The questionnaire evaluates performance across several categories: quality of product or service, price control, timeliness/schedule, business relationships, and key personnel. Each category uses a six-point scale (Exceptional to Unknown) to assess performance and associated risk levels. Additionally, it asks if the contractor would be re-awarded a contract, if previous contracts were terminated for default, or if cure notices were issued. All ratings of Unsatisfactory, Marginal, Very Good, or Exceptional require supporting comments. This detailed assessment helps the government evaluate an offeror's past performance and predict future risk.

This document, "ATTACHMENT 2 (VHA PBM Guidance for Compounded Sterile Products (CSPs)", outlines the regulatory requirements for both outsourced compounding pharmacies and VAMC pharmacies concerning Compounded Sterile Preparations (CSPs). It details compliance standards across various areas including HIPAA, EPA regulations for waste disposal, accreditation for compounding, obtaining active pharmaceutical ingredients (APIs) from FDA/DEA-registered suppliers, pharmacy licensing, pharmacist-to-technician ratios, DEA registration for controlled substances, staff licensing/certification, adherence to USP <797> standards, and contingency plans. The document serves as an assessment guide, highlighting specific requirements for VAMCs, especially when preparing high-risk CSPs or purchasing APIs for compounding, and emphasizes the VAMC's responsibility to evaluate outsourced pharmacies' compliance with corrective actions for any regulatory violations.

The document provides a detailed list of oncology products and ancillary supplies, including their NDC/REF numbers and quantities across various facilities such as Columbia, Eastern Kansas, Kansas City, Marion, Poplar Bluff, St. Louis, and Wichita, culminating in an 'All Facilities' total. The oncology products range from ado-trastuzumab emtansine to zoledronic acid, with varying quantities reported for each. Ancillary products include items like bag adapters, empty EVA bags of different sizes, connectors, dispensing fees, extension sets, homepump C devices, sodium chloride injections, sterile water, syringes, and vial adapters. The final section presents 'Potential Contract Totals' for both oncology and ancillary products across all listed facilities, indicating a cumulative demand. This document appears to be part of a procurement or inventory assessment for medical supplies, likely for a healthcare system or government agency managing these facilities.

The Department of Veterans Affairs (VA) is soliciting proposals for a five-year Requirements Contract for Hazardous and Non-Hazardous Pharmacy Compounded Sterile Preparation Services for VISN 15 pharmacies. This firm-fixed-price contract will serve as a contingency plan during planned or unplanned downtime in VA pharmacy sterile compounding areas due to upgrades, construction, or other disruptions. The contractor will provide all necessary medications, diluents, fluids, IV tubing, and other compounding and administration supplies. Services must comply with FDA 503A regulations, state and federal laws, USP <797>, <800>, and <795> standards, and VHA Directive 1108.12. Deliveries are required by 9:00 AM CST the day after an order is placed by 2:00 PM CST. The contract includes specific requirements for prescription orders, delivery locations, compatibility needs for IV sets and devices, and quality assurance. The contractor must also provide and update a VHA Pharmacy Benefits Management (PBM) Assessment Guide annually and have a contingency backup plan for their compounding facility. The contract will serve multiple VA Medical Centers across Missouri, Kansas, Illinois, and Indiana.

The Department of Veterans Affairs (VA), Network Contracting Office 15 (NCO15), issued a pre-solicitation notice for an unrestricted, single-award, VISN-wide Indefinite Delivery/Requirements Contract. This contract will procure hazardous and non-hazardous compounded intravenous products and associated supplies, including medications, diluents, fluids, IV tubing, and other compounding and administration items. All sterile products must be aseptically compounded according to patient-specific orders and comply with USP 797, USP 800, the Drug Supply Chain Security Act (DSCSA), and all applicable federal, state, and local regulations. Vendors must ensure proper delivery, handling, and storage, including segregation and labeling for hazardous versus non-hazardous compounds. Additionally, the contractor will be required to provide and annually update the VHA Pharmacy Benefits Management (PBM) Assessment Guide for Compounded Sterile Preparations. The NAICS Code is 325412 (Pharmaceutical Preparation Manufacturing) with a size standard of 1300 employees, and the Product Service Code is Q517 (Pharmacy Services). All potential vendors must be registered and active in SAM. The solicitation, number 36C25526R0023, is expected to be issued around February 6, 2026, and will be available exclusively on www.sam.gov. The response deadline is January 29, 2026, at 1:00 PM Central Time. No phone, fax, or email inquiries will be accepted for this pre-solicitation notice.