Assigning roles across a care team
If purchasing, receiving, and documentation questions will be handled by different people, define each role in writing: who may authorize a purchase, who receives and logs a shipment, and who answers a referring provider's documentation question.
Give administrative staff clear access to the vendor documentation they need without extending purchasing authority beyond who the practice has authorized.
- Define who may authorize a purchase under the verified account
- Separate receiving and filing duties from purchasing authority, if useful
- Give administrative staff access to the documentation they need
- Define who responds to documentation questions from referring providers
Choosing documentation staff can file correctly
If staff without a clinical credentialing background will be filing paperwork, ask for documentation formats labeled clearly enough to match a certificate of analysis or lot release record to the right inventory entry without guesswork.
A short internal reference sheet translating vendor document names into your own filing categories can reduce misfiling when staff change.
- Ask for documentation formats labeled clearly for non-specialist filing
- Consider a reference sheet mapping vendor terms to filing categories
- Retrain staff on filing procedures when roles change
- Confirm lot numbers on paperwork match physical labeling on each vial
What to share with a referral network
If referring physicians ask about sourcing, a short, factual summary limited to verifiable facts, how lots are tested and tracked, is more defensible than any description of what a product does, which remains a determination for the treating physician and counsel.
Update that summary whenever vendor documentation changes, and make it available to referring providers on request rather than publishing it broadly.
- If asked, share a factual, documentation-based summary with referring providers
- Limit the summary to sourcing and testing facts, not use
- Update the summary when vendor documentation changes
- Make documentation available to referring providers on request
Keeping regulatory review current
Whether a specific intended use meets all applicable criteria in 21 CFR 1271.10 is a determination for the practice and its counsel. If staffing or product formats change, consider re-confirming that review rather than treating an initial check as permanent.
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.
- Schedule periodic regulatory review with counsel, not a one-time check
- Re-confirm documentation habits when new staff join
- Review intended use again when adding a new product format
- Keep a written record of each regulatory review date
Frequently asked questions
Who should hold purchasing authority for biologics in a PM&R practice?+
That is for the practice to decide and document. Many practices keep purchasing authority with the supervising physician while administrative staff handle receiving and filing, but the specific arrangement should be written down.
How should documentation be organized for staff without clinical training?+
Clearly labeled certificates of analysis and lot release records, paired with an internal reference sheet, can help staff file paperwork correctly and match it to physical inventory.
What should a PM&R practice tell referring physicians about sourcing?+
A short, factual summary limited to how lots are tested, tracked, and documented, without describing what any product does, since that determination belongs to the treating physician and counsel.