HRSA Schedules Tele-Hearings
on National Cord Blood Inventory Program
Two conference call hearings have been scheduled for public comment on the accreditation of cord blood banks within a National Cord Blood Inventory Program.
The Health Resources and Services Administration (HRSA) has scheduled the hearings for:
2:00 pm - 4:00 pm EDT on Tuesday May 9
2:00 pm - 4:00 pm EDT on Monday May 15
Logistics
Advance registration is required to participate in either of the conference call hearings. The number of participants will be limited, and registration is on a first-come basis. The deadline for registering is May 3.
Individuals wanting to participate can call Anita Wabeke at HRSA at (301) 443-4747.
Issues
HRSA has indicated its specific interests are:
- Approaches to accreditation to ensure quality cord blood bank operations
- Utilization of accreditation programs to ensure product quality and best practices
- Degree to which accreditation standards are evidence-based and supported by published literature
- Extent to which accreditation standards allow for variations in cord blood bank practices
- Criteria for the HHS Secretary to consider in recognizing one or more cord blood bank accreditation programs
Background
The Stem Cell Therapeutic Act of 2005 established the National Cord Blood Inventory and the C.W. Bill Young Cell Transplantation Program.
Cord blood banks that collect and maintain units for the national inventory must meet statutory requirements, which include HRSA-sanctioned accreditation.
FACT/NetCord Accreditation
Over the past several years, The Foundation for Accreditation of Cellular Therapy (FACT) has developed standards, trained inspectors and awarded accreditation to cord blood banks. Currently nine banks have achieved accreditation, and 34 others have registered or are in the process of seeking accreditation.
The FACT cord blood standards and acccreditation program have been developed in cooperation with The NetCord Foundation, a worldwide association of cord blood banks. FACT is a subsidiary of ASBMT and the International Society for Cellular Therapy.
FACT has applied to HRSA to be recognized as the accrediting agency for cord blood banks under the National Cord Blood Inventory Program. However, competition is expected from other agencies, including a proposal that there be multiple accrediting agencies.
The Case for FACT
FACT/NetCord leaders point to several advantages that their organization can offer:
- The standards are high, evidence-based and developed by transplant clinicians and banking industry peers.
- Inspections are conducted by experts in the field who spend typically two days on site reviewing processes and interviewing staff.
- Accredited facilities must have a quality management and improvement program for codifying processes, avoiding errors, enhancing internal and external communications and recording and reporting treatment outcomes.
- Inspection findings are submitted to an accreditation committee that ensures accuracy and consistency.
- Due process is available to resolve any questions or disagreements about accreditation decisions.
The HRSA notice of the two teleconference hearings is posted on the ASBMT Web site.