Responsible buyer
Target buyer Economic buyer: ASC Administrator / Executive Director / Managing Partner (physician-owner groups) Day-to-day: Designated Infection Preventionist / Infection Control Nurse; sometimes OR Director or Clinical Director who owns reprocessing documentation ICP beachhead: Independent Medicare-certified ASCs in FL / TX / CA / AZ with on-site steam sterilization and at least one implant-heavy specialty (ortho, spine, ophthalmology lenses/implants, ENT, plastics), 1–3 ORs, no full-time SPD manager Secondary: Small ASC management companies (5–25 centers) wanting a standardized documentation
Cost of the gap
Painful problem CMS surveyors use Exhibit 351 and score sterilization documentation including: chemical indicators in packs, biological indicators weekly and with every implantable load (as evidenced by log), mechanical monitoring, and up-to-date load documentation. ASCs with thin sterile-processing staffing commonly have: missing BI results, delayed entries, implant loads released without quarantine notes, IUSS rates that look like inventory shortages, and binders that do not reconcile to OR case volume.
Outcome
The outcome we sell Outcome sold: A specialist-released Implant BI-Load Completeness Pack for one named ASC site and one lookback period — including (1) load inventory extracted from sterilizer records, (2) implant-load identification against OR schedules / implant logs, (3) BI/CI/mechanical evidence matrix, (4) gap list mapped to Exhibit 351 sterilization items, (5) IUSS & early-release exception register, (6) remediation checklist the ASC IP can execute, and (7) survey-ready PDF binder section with audit trail. Never sterility certification. Never a customer-operated dashboard as the product.
Decision rule
Proceed only when the source record, service boundary, responsible reviewer, and release criteria can be named before work begins.