In response to oversight and regulation by the FDA and other regulatory agencies (CLIA, SART, ASRM, CAP, JCAHO, etc.) the American Association of Bioanalysts – College of Reproductive Biology has formed a task force to provide ART professionals with a forum for influencing current and future regulation of our field. The name of the task force is the College of Reproductive Biology Regulatory Task Force (CRB-RTF).
The goal of the CRB-RTF is to provide a forum for those in reproductive facilities to discuss regulatory issues, provide public comment on impending regulation, educate persons working in reproductive facilities concerning existing regulation and provide standards, policies, and procedures for use in meeting regulations.
Our first goal is to examine the FDA Current Good Tissue Practice regulation for HCT/Ps to determine how these regulations would impact our field should they be implemented for reproductive facilities. We are particularly interested in the section of this regulation concerning cryopreservation of tissues. The CRB-RTF is currently compiling a position paper on this issue as it relates to reproductive tissues. The position paper is to be followed by a CRB Policy and Procedure Standards manual that can easily be adopted throughout the ART industry. The first area of focus for the Standards will be storage of cryopreserved tissues, and is currently in development. This manual will be similar in format to the AAB manual already available for HCT/Ps.
Specific questions regarding compliance issues can be sent to the CRB-RTF e-mail address CRB_RTF@aab.org.
Board Members
| Chair | Members |
| Stan Harris, BS, TS/ELD(ABB) ART Laboratories General & Technical Supervisor Methodist Hospital |
Rita Basuray, Ph.D., HCLD(ABB) Joe Conaghan, Ph.D., HCLD/ELD(ABB) Director, ART Laboratories Pacific Fertility Center Kimball Pomeroy, Ph.D., HCLD(ABB) Laboratory Director Arizona Reproductive Medicine Specialists Grace M. Centola, Ph.D., HCLD(ABB) |
| Vice-Chair | |
| Margaret Papadakis, Ph.D., HCLD(ABB) ART Laboratory Director The Center for Reproduction Carolinas Medical Center |
|
| Secretary | Liaison |
| David Battaglia, Ph.D., HCLD/ELD(ABB) Director Andrology/Embryology Laboratory OHSU Fertility Consultants Oregon Health and Science University |
Tammie Schalue, PhD, HCLD/ELD(ABB) Associate Administrator AAB College of Reproductive Biology American Association of Bioanalysts |
The contents of the CRB website, including information regarding regulatory developments, responses to questions, and other information and materials are for informational purposes and to assist the user in understanding or complying with applicable laws or standards of practice. They are not intended to indicate approval or guidance by any regulatory agency, and are not intended as a substitute for professional legal advice. Always seek the advice of a qualified attorney with respect to any questions over compliance with federal or state laws.
