Skin substitute tissue log requirements

We use mostly Puraply and Epifix, and log the application number, lot number, and waste in the EMR. We also separately keep a paper log of the same information, in case of a JCAHO visit. Do you know what the CMS requirements are with regard to skin substitute logs? Is the above information in the patients EMR application sufficient, or is a daily tissue log needed? Also, is documentation of the cm2 tissue waste needed for each application?
Thanks

Jul 18, 2023 by Bill Khoury,

1 replies

Elaine Horibe Song
MD, PhD, MBA

Hi Dr Khoury,

Thank you for your message! For comprehensive guidance on CMS documentation requirements for CTPs, please refer to:
- Section 'Documentation requirements' in topic "Cellular and/or Tissue Based Products" at https://woundreference.com/app/topic?id=cellular-andor-tissue-products#coding,-coverage-and-reimbursement . More specifically, Table 3 in that section, which shows a checklist for Medicare documentation requirements to justify use of CTPs,
- Tool "Request for Cellular and/or Tissue Products" at https://woundreference.com/files/1559.pdf

Of note, documentation of amount of product unit discarded - wastage - and reason for the wastage are some of the items included the checklist of CMS documentation requirements.

The resources above list CMS requirements in an itemized format so that EMR templates can be created if desired.

Hope this helps!

Jul 19, 2023

* Information provided without clinical evaluation and is not intended as a replacement for in-person consultation with a medical professional. The information provided through Curbside Consult is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

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