April 7, 2015 - April 8, 2015
NIH Conference Room
5635 Fisher’s Lane, Terrace Level
Rockville, MD 20852
Agenda
Tuesday, April 7, 2015
| Time | Agenda Item | Presenter |
|---|---|---|
| 07:30 (30 min) |
Doors Open | Open to the Public |
| 08:00 (10 min) |
Call to Order | Jay Menitove, MD Committee Chair |
| 08:10 (5 min) |
Roll Call | James Berger Executive Secretary |
Committee Business
| Time | Agenda Item | Presenter |
|---|---|---|
| 08:15 (10 min) |
Principal Deputy Assistant Secretary for Health’s Charge to the Committee | Wanda Jones, DrPH Principal Deputy Assistant Secretary for Health |
| 08:20 (5 min) |
Recognition of Retiring Members | Jay Menitove, MD Committee Chair |
Advisory and Subcommittee Committee Updates
| Time | Agenda Item | Presenter |
|---|---|---|
| 08:30 (15 min) |
ACOT Update | Melissa Greenwald, MD Medical Officer, Division of Transplantation HRSA |
| 08:45 (15 min) |
Update on the Establishment of a Transfusion Transmitted Infectious Disease Monitoring System | Alan E. Williams, Ph.D. Associate Director, Office of Blood Research and Review CBER, FDA |
| 09:00 (10 min) |
ACBTSA Subcommittee on Blood System Sustainability | Jay Menitove, MD Committee Chair |
Overview of Tissue
| Time | Agenda Item | Presenter |
|---|---|---|
| 09:10 (30 min) |
Overview of Tissue Tracking and Traceability | Laura St. Martin, MD, MPH CGTP Team Lead, Division of Human Tissues, FDA |
| 09:40 (20 min) |
Applications of Allograft Tissue for Children and Adults Undergoing Cardiac Surgery | Richard A. Jonas, MD Chief, Cardiac Surgery Co-Director, Children's National Heart Institute Children's National Health System |
| 10:00 (30 min) |
Informatics Standards for Track and Trace to the Patient Level | Gregory G. Zeller, DDS, MS Chair, ANSI-Accredited American Dental Association Standards Committee for Dental Informatics Associate Dean for Clinical Affairs University of Kentucky College of Dentistry |
| 10:30 | Break • 10 min |
Human Tissue Grafts: Recovery to Consignment
| Time | Agenda Item | Presenter |
|---|---|---|
| 10:40 (30min) |
FDA Tissue Tracking Regulations | Safa Karandish Division of Human Tissue, FDA |
| 11:10 (30 min) |
New York State Oversight of Tissue | Jeanne Linden, MD, MPH, FCAP Director, Blood and Tissue Resources New York State Department of Health |
| 11:40 (30 min) |
Florida’s Regulatory Role in Tissue Banking | Dayle D. Mooney Program Administrator Agency for Health Care Administration, State of Florida |
| 12:10 | Lunch Break • 45 min | |
| 12:55 (30 min) |
AATB Standards, Guidance, Policies and Relevant Data | Scott Brubaker, CTBS Sr. Vice President of Policy, AATB |
| 01:25 (30 min) |
EBAA Medical Standards: Tissue Tracking and Traceability | Marian Macsai, MD Past Chair, EBAA Board of Directors Chief, Division of Ophthalmology, NorthShore University HealthSystem |
| 01:55 (30 min) |
Tissue Management System from Donor Recovery to Consignment | Tim Maye Senior Director of Quality Systems LifeNet Health |
| 02:25 | Break • 10 min | |
| 02:35 (30 min) |
MTF Tissue Tracking and Traceability | Joe Yaccarino Executive Vice President, Operations Musculoskeletal Transplant Foundation |
| 03:05 (45 min) |
Committee Questions and Discussion | |
| 03:50 | Adjournment | Jay Menitove, MD Committee Chair |
Wednesday, April 8, 2015
| Time | Agenda Item | Presenter |
|---|---|---|
| 07:30 (30 min) |
Doors Open | Open to the Public |
| 08:00 (10 min) |
Call to Order | Jay Menitove, MD Committee Chair |
| 08:10 (5 min) |
Roll Call | James Berger Executive Secretary |
Human Tissue Grafts: Consignment to Final Disposition
| Time | Agenda Item | Presenter |
|---|---|---|
| 08:15 (15 min) |
Management of Tissue Grafts by End Users and the Role of Professional Associations | Scott Brubaker, CTBS Sr. Vice President of Policy, AATB |
| 08:30 (30 min) |
Joint Commission Accreditation Standards for Tissue Safety | Christina Cordero, PhD, MPH Associate Project Director Department of Standards and Survey Methods Division of Healthcare Quality Evaluation The Joint Commission |
| 09:00 (30 min) |
Role of EHR in Tissue Tracking | David R. Hunt, MD Medical Director, Health IT Adoption & Patient Safety Office of the National Coordinator for Health IT |
| 09:30 (30 min) |
Human Allograft Management within the Transfusion Service | Heather McGann, MS, MT(ASCP), SBB Manager, Transfusion Service and Tissue Bank Sinai Hospital of Baltimore |
| 10:00 | Break • 10 min | |
| 10:10 (50 min) |
System for Tissue Management and Tracking | Rajni Parmar, RN, MSN, PhD candidate Banner University Medical Center, Tucson, AZ |
| 11:00 (30 min) |
VA oversight of Biologics/Tissue | Michael S. Icardi, MD National Director of Pathology and Laboratory Medicine Services National Director of Biologics U.S. Department of Veterans Affairs |
| 11:30 (15 min) |
Open Public Hearing (all sessions/considerations) | |
| 11:45 | Lunch Break • 45 min |
Investigation of Potential Donor-derived Disease Transmissions
| Time | Agenda Item | Presenter |
|---|---|---|
| 12:25 (30 min) |
Investigations of Tissue-Transmitted Infection: Challenges for Patient Safety | Matthew J. Kuehnert, MD Director, Office of Blood, Organ, and Other Tissue Safety CDC |
| 1:00 (30 min) |
Notification Process of Suspected Donor-Derived Infection in Organ Recipient | Shandie Covington Policy Manager Ad Hoc Disease Transmission Advisory Committee Liaison United Network for Organ Sharing |
| 01:30 (30 min) |
Notification Process of Suspected Donor-Derived Infection in Tissue Recipient | Carrie Hartill Executive Vice President and Chief Scientific Officer RTI Surgical Inc. |
| 02:00 | Break • 10 min | |
| 02:10 (90 min) |
Committee Questions, Discussion, and Recommendations | |
| 3:40 | Adjournment | Jay Menitove, MD Committee Chair |
