10 States with Special Tissue Vendor Standards

April 14, 2011 at 6:53 pm Leave a comment

While at Health Care Compliance Association (HCCA) 2011 Compliance Institute in Orlando earlier this week, we met with a number of compliance officers who were concerned about vendors that weren’t in their vendor compliance/credentialing records.

One of the top concerns was tissue vendors. Tissue vendors are easy to overlook. But hospitals should be aware of the special documentation requirements related to these suppliers.

First, the FDA requires all human cells / tissues establishments to register with them annually.  The FDA then issues a form to the company.

Second, 10 states require annual licenses or registrations for tissue vendors:  California, Delaware, District of Columbia, Florida, Georgia, Illinois, Maryland, Mississippi, New York, Oklahoma, and Oregon.  (See more detail at AATB.)

Why does this matter to you?

Because, the Joint Commission reiterates these requirements. It doesn’t create any requirements for implanting and transplanting organizations, only to keep a record of the source’s FDA and state status.

The Joint Commission standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file.

Consider adding the annual FDA registration form and any state documents to your vendor information management system. In Vendormate’s case, it would work just like any other document with an expiration date and a requirement to update annually.

Entry filed under: vendor credentialing, vendor credentials. Tags: , , .

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