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Comments to FDA on Draft Guidance for Industry: "Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception"

December 22, 2014

Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No. FDA-2014-D-1584 “Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.”


Dear Dockets Manager:

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

AABB appreciates the opportunity to provide comments on the draft guidance titled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” In developing these comments, AABB collected feedback from members with cellular therapy expertise. In general, we commend FDA on developing this guidance document which, when finalized, will be a useful resource for clarifying the scope of exception set forth in 21 CFR 1271.15(b). Listed below is one specific area that we feel would benefit from wording modification.

Section – II. BACKGROUND. Para 1, page 3, lines 87-92. In reaching this conclusion, we note that hospitals that store autologous cells or tissues for subsequent application in the same patient must follow the guidelines of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for tissue storage, monitoring of storage devices, and tracking in order to obtain or maintain accreditation (66 FR 5447 at 5460).

Recommendation – We recommend revising to the following: “In reaching this conclusion, we note that hospitals that store autologous cells or tissues for subsequent application in the same patient must follow the guidelines of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or those of a CMS-approved accreditation organization for tissue storage, monitoring of storage devices, and tracking in order to obtain or maintain accreditation (66 FR 5447 at 5460).”

Rationale: Not all US hospitals are accredited by JCAHO. There are also other accrediting organizations that are CMS-approved accreditation organizations.1  Examples include:

- Accreditation Association for Ambulatory Surgery Facilities (AAAASF)
- American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP)
- Center for Improvement in Healthcare Quality (CIHQ)
- Det Norske Veritas Healthcare (DNV Healthcare)

It is quite likely that a hospital accredited by one of the CMS-approved accreditation organizations may store tissue/cells for autologous use. These facilities should be held to the same storage monitoring and tracking requirements as JCAHO facilities, assuring the quality of the tissues/cells.

AABB and the Regulatory Affairs Subsection of the AABB Center for Cellular Therapies appreciate the opportunity to comment on the draft guidance. Should you have any questions regarding these comments or would like additional information, please contact Dr. Naynesh Kamani by email (nkamani@aabb.org) or telephone (301.215.6580).


Respectfully Submitted,

Naynesh Kamani, MD
Division Director, Cellular Therapies

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1Retrieved from the World Wide Web December 16, 2014: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/AOContactInformation.pdf. CMS-Approved Accreditation Organizations.