SAM #36C25727Q0032

VA sterile compounding facility certification, testing, and staff qualification services

The Department of Veterans Affairs is seeking multi-year sterile compounding facility certification, environmental testing, and staff qualification services for its South Texas facilities. - Government buyer - Department of Veterans Affairs (VA), South Texas Veterans Health Care System; work is for the Audie L. Murphy Memorial VA Hospital Pharmacy Services. - Contracting office: NCO 17, Regional Procurement Office West. Stephanie Reeves is named as the contracting contact in the solicitation summary. - Scope of services - Certify hazardous-drug containment areas, storage rooms, biological safety cabinets (BSCs), and laminar airflow workbenches/cabinets (LAFWs/LFCBs); perform air-change and pressure testing where specified. - Conduct viable environmental sampling monthly across seven primary engineering controls, hazardous-drug residue sampling at six locations, and remedial testing after failed certification or sampling. - Qualify pharmacy personnel, including testing for up to 80 staff members involving gloved fingertip tests, media fills, and direct-compounding-area surface sampling; provide remedial and initial qualification testing as scheduled. - Provide required labor, equipment, testing documentation, travel, and maintenance part repair or replacement. An appendix also describes competency assessments for hazardous-drug handling, BSC use, cleaning, waste handling, PPE removal, and spill response. - Quantities and schedule - The performance work statement lists BSC certification (4), LFCB certification (10), monthly viable sampling (84), hazardous-drug residue sampling (6 locations), and personnel-related testing line items, including 160 personnel qualification tests and 20 remedial tests. - Other listed service quantities include two hazardous-drug containment-area certifications, two storage-room tests, one equipment remedial-testing line, 20 initial qualifications, 20 gloved fingertip test sets, and 12 media-fill retests. The solicitation schedule and performance work statement show some differing quantities for travel and certain retest items; verify against the current schedule before pricing. - The contract is structured as a 12-month base period with four 12-month options; a separate extension may add up to six months. - Key requirements - Work must meet applicable USP and requirements. Required qualifications include CETA CNBT sterile-compounding certification and NSF/ANSI 49 biosafety-cabinet field-certifier credentials; the performance work statement also specifies ISO/IEC 17025 laboratory accreditation. - The solicitation is a 100% set-aside for certified service-disabled veteran-owned small businesses (SDVOSBs). - OEMs and vendors - No product OEMs, equipment manufacturers, or commercial vendors are named in the opportunity. No product part numbers are provided.

Description

The South Texas Veterans Health Care System requires contractor services to perform testing and certification of sterile compounding facilities, including primary and secondary engineering controls as described in the attached Performance Work Statement (PWS), at the Audie L. Murphy Memorial VA Hospital Pharmacy Service. All work shall be performed in accordance with applicable standards and the related testing described in the attached PWS. The contractor shall provide all labor, equipment, and documentation needed to fulfill the requirements outlined in the PWS.

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