Article · Compliance & Audit Readiness
If a surveyor walked into your facility today and asked about your allograft tissue program, could your team answer these five questions?
If a surveyor walked into your facility today and asked about your allograft tissue program, could your team answer these five questions?
Most ASC administrators can answer some of them immediately. Almost none can answer all five without reaching for a binder — or making a call.
Here they are:
If your freezer failed tonight, who is financially responsible for the tissue inside it?
This one stops most people cold (no pun intended). The answer seems like it should be obvious — but in practice, the financial exposure for tissue loss due to equipment failure sits in different places depending on how your storage agreement is structured.
If your facility owns the freezer, you likely own the risk.
If you have a vendor-provided freezer, check your agreement carefully — indemnification language varies widely, and "we'll replace the freezer" is not the same as "we'll replace the tissue."
Knowing the answer before a failure occurs is significantly better than discovering it after.
Can you trace any graft from donor to patient in under five minutes?
This is the core of FDA compliance for allograft tissue under 21 CFR Part 1271. Not "could you eventually figure it out" — but within minutes, using your actual documentation system.
If the answer requires a spreadsheet search, a phone call to your rep, or locating a paper log from six months ago, that's the gap auditors find. The good news: it's also one of the most straightforward gaps to close with the right tracking system in place.
When were your freezer temperature probe and monitoring system last calibrated — and where is the certificate?
Accrediting bodies expect calibration certificates to be on file and current. Documentation deficiencies in this area are not uncommon during tissue-related audit reviews — not because facilities aren't maintaining their equipment, but because the paperwork isn't organized for rapid retrieval.
If you know the answer immediately, your program is in good shape on this one. If you're not sure, it's worth confirming before someone asks under pressure.
What happens to a scheduled case if the graft doesn't arrive or doesn't meet spec?
Surgeon preference doesn't always match donor availability. Graft specifications — particularly diameter, length, and donor age requirements — can create bottlenecks when availability is limited.
The highest-performing ASCs handle this before it becomes an emergency. They have pre-approved contingency options documented with each surgeon: if the preferred graft isn't available, what's the acceptable alternative? That conversation, had in advance, is the difference between a delayed case and a case that proceeds on schedule.
If your facility doesn't have documented contingency plans by surgeon, this is worth addressing — not because shortages are common, but because when they happen, you want the answer to already exist.
What did your tissue program actually cost your facility last year — not the invoice total, but the total cost?
Invoice price is the number everyone knows. Total cost of ownership is the number almost nobody has calculated.
Add up the freezer capital and maintenance, the temperature monitoring subscription, the restocking fees on returned grafts, the expedited shipping charges when a case comes in last-minute, and the staff hours spent managing it all. That number is frequently larger than the invoice total alone — sometimes by a meaningful margin.
You don't have to calculate it with perfect precision. But having a working estimate changes the conversation you're able to have about your tissue program — with your leadership, your vendors, and anyone who asks why you're evaluating alternatives.
None of these are trick questions. They're the operational foundations of a compliant, efficient, audit-ready tissue program.
The facilities that can answer all five immediately have built systems — for documentation, for traceability, for contingency planning, for cost visibility. Those systems take time to build, but once they're in place, they run largely on their own.
The facilities that can't answer them yet are carrying risks they may not have fully quantified. The good news is that each of these gaps has a practical solution — and identifying which ones apply to your facility is the first step toward closing them.
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