USP-797 Cleanroom Certifications and Equipment Maintenance

The Indian Health Service Lawton Service Unit is soliciting for USP-797 cleanroom certifications and equipment maintenance services, with a pre-solicitation due date of September 1, 2026. This procurement is set aside for Indian Small Business Economic Enterprises under the Buy Indian Act.

Work is performed at Lawton Indian Hospital, 1515 Lawrie Tatum Road, Lawton, Oklahoma. The contractor shall provide biannual re-certifications of the ante room, buffer room, and hazardous drug buffer room, along with certifications for biological safety cabinets and laminar airflow workstations. Services include HEPA filter integrity testing, airborne non-viable particle counting, microbiology sampling, equipment maintenance, ceiling HEPA filter changes, and diagnostic and repair services for cleanroom equipment with minimal downtime expectations. All testing must comply with manufacturer specifications, USP Chapter standards, and ISO standards 14644-1:2015 and 14644-3:2019(E), as well as CETA CAG standards CAG-008-2010, CAG-009-2011v3, and 003-2022.

The contractor must furnish all personnel, materials, supplies, and equipment including certification testing equipment, tryptic soy agar plates, and air sampling equipment. The base contract period is 12 months from date of award with four optional 12-month renewal years. The contractor shall designate a point of contact, maintain a toll-free service line answered 8:00 am to 4:30 pm Monday through Friday, and respond to urgent equipment service requests on a timely basis. Deliverables include reports with findings and recommendations, certificates of analysis, microbiology sampling maps, and trending reports. Contractor employees must comply with security clearance guidance, tobacco and smoke-free environment policies, and facility access and confidentiality requirements.

Offerors must complete the Buy Indian Compliant Form certifying Indian Economic Enterprise status and maintain eligibility at offer submission, award, and throughout contract performance.