Selection of Cord Blood Collection Sites for FACT Inspections
By Cathy Talmadge, FACT Accreditation Services Supervisor
Cord blood collection sites are selected for inspection based on specific variables in order to evaluate compliance with the NetCord-FACT Standards. Cord blood banks should be aware that sites they consider to be “non-fixed” may be inspected during the next FACT inspection depending on the site’s ongoing responsibilities and number of collections performed.
In order to prevent issues upon scheduling the inspection, FACT recommends that cord blood banks inform their non-fixed collection sites that an on-site FACT inspection may occur. The following information may be helpful to non-fixed collection sites who are unfamiliar with FACT accreditation and processes:
- The mission of FACT is to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients. WMDA-NetCord’s mission is to support, promote, and enhance safety, efficacy, and availability of international exchange of cord blood units and to harmonize global practice of cord blood banking and supply. Accreditation is achieved by demonstration of compliance with the current edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration (the “Standards”). The Standards have been developed to promote quality medical and laboratory practices throughout all phases of cord blood collection, banking, and release for administration to achieve consistent production of quality placental and umbilical cord blood units for administration. They are developed by world-renowned experts in the field including clinicians, collection professionals, laboratory scientists, technologists, and quality experts. The Standards are based on published medical literature, when available, and accepted scientific theory and expert consensus. The Standards define minimum requirements to reach a level of quality worthy of accreditation and allows flexibility in methods/processes to meet requirements.
- To be eligible for accreditation, a cord blood bank must have processes in place to meet all of the Standards, whether the activities are performed internally or by contract with another facility. The inspection and accreditation process is summarized on the FACT website and includes an on-site inspection of the bank, cord blood collection sites, and cord blood processing and storage facilities. Because they perform a critical step of the cord blood banking process, facilities that collect cord blood units for an applicant bank are inspected during the accreditation process. Collection sites are selected depending on a number of variables to allow verification of compliance of all processes used by the bank.
- At least one staff member of the cord blood bank pursuing accreditation accompanies the inspector during the on-site inspection of collection sites. The FACT inspectorate consists of experienced individuals active in the field who have a strong and vested interest in ensuring the availability of the highest quality cord blood units for administration. The inspectorate includes transplant physicians, cord blood bank directors and medical directors, cord blood collection directors, and cord blood processing facility directors. Inspectors complete an inspector training course, pass a written exam, participate in at least one inspection as a trainee inspector, and participate in ongoing education.
- The cord blood bank will work with the selected collection sites during the preparation for inspection, including document submission, compilation of evidence, and scheduling the inspection. Any deviations noted during the inspection will be reviewed by the FACT Accreditation Committee comprised of leaders in the field of cord blood banking. The cord blood bank will be provided with the committee findings and is responsible for correcting any deficiencies identified. FACT encourages collection sites to maintain close communication with the cord blood bank as they prepare for an inspection.