Integrating biologics into central supply systems
If central supply already tracks implants and other regulated items by lot, ask whether a new vendor's lot numbering, certificate format, and shipping documentation can integrate into that existing system rather than running a separate process.
Assign central supply staff to review documentation fit before the first order, since a second, incompatible documentation system adds administrative burden.
- Confirm vendor documentation can integrate with existing central supply systems
- Avoid running a separate documentation process for one vendor, if avoidable
- Check lot numbering format compatibility before committing
- Assign central supply staff to review documentation fit
Setting credentialing policy for ordering and use
If multiple physicians are credentialed at your facility, decide at the facility level who can authorize a biologics purchase and keep a credentialing record linking each physician's privileges to the product categories they may use there.
Review that credentialing record when a physician's privileges change.
- Set a facility-level policy for who can authorize biologics purchases
- Link physician credentialing records to permitted product categories
- Decide whether individual vendor relationships are appropriate for visiting physicians
- Review credentialing records when privileges change
Preparing documentation for surveys
If your facility operates under Medicare certification or accreditation standards, confirm whether periodic surveys review how regulated inventory, including biologics, is sourced, tracked, and stored.
Keep certificates of analysis, donor eligibility summaries, and lot release records organized ahead of any scheduled survey rather than assembling them when asked.
- Confirm whether your accreditation standard addresses biologics inventory
- Keep documentation organized ahead of scheduled surveys
- Assign a specific role to respond to surveyor documentation requests
- Review documentation organization periodically, not only before a survey
Separating facility accreditation from regulatory classification
Facility accreditation and Medicare certification address operational and safety standards. Whether a specific product and intended use meet all applicable criteria in 21 CFR 1271.10 is a separate determination for the facility's and physicians' own counsel.
These products are not FDA approved or licensed for any disease or condition. Information here is for licensed healthcare professionals and is not medical or legal advice.
- Treat facility accreditation and HCT/P classification as separate reviews
- Confirm regulatory classification with counsel independent of survey results
- Revisit regulatory review if a new product or format is added
- Document both reviews separately in facility compliance records
Frequently asked questions
Does an ASC evaluate biologics vendors at the facility or physician level?+
That depends on how the facility is structured. Many multi-specialty centers evaluate at the facility level so inventory integrates with central supply, but confirm and document the approach your facility uses.
How should a multi-specialty ASC manage credentialing for biologics purchasing?+
By linking each physician's credentialing record to the product categories they are permitted to order or use at that facility, rather than leaving purchasing access open.
Does passing an accreditation survey confirm a product's regulatory classification?+
No. Accreditation and Medicare certification address facility operations and safety. Regulatory classification under 21 CFR 1271.10 is a separate determination for counsel.