By: Cassie Kennedy, BS, FACT Accreditation Coordinator
All editions of FACT-JACIE International Standards for Hematopoietic Cellular Therapy, NetCord-FACT Standards for Cord Blood Banking, FACT Common Standards, and FACT Immune Effector Cell Therapies require that there be Directors and Medical Directors of the program, bank, and participating facilities. Standards define specific qualifications and responsibilities, but are silent on residency requirements and on the distances among accredited programs or facilities for which one individual serves as director.
Remote Directors and Medical Directors are those directors with professional responsibilities in more than one metropolitan geographic area, or those whose residence is outside of the metropolitan geographic area of the accredited facility. The FACT Accreditation Committees have increasingly noted instances of remote directors who purportedly are responsible for two or more accredited facilities outside of a single metropolitan area, hundreds of miles apart, or in another country. Most commonly, these facilities are apheresis centers, processing facilities, or cord blood banks; however, clinical program directors also have raised similar questions. The concern is whether or not the Collection and Processing Facility Directors who oversee multiple sites in various states or regions, or who live in states or countries distant from the accredited facilities they oversee, are present enough to fulfill the role as intended in the Standards.
The Remote Directors Task Force
The Task Force was constituted in July 2017 to develop recommendations regarding minimal on-site requirements, or suitable alternative arrangements, for Directors and Medical Directors of FACT-Accredited Apheresis Collection Facilities, Processing Facilities, and Cord Blood Banks.
The Task Force membership was diverse, including directors, medical directors, and non-directors in Cellular Therapy Programs (Clinical, Collection, and Processing) and Cord Blood Banks.
The Task Force reviewed the Director and Medical Director responsibilities as detailed in the Standards. They considered examples of facilities wherein citations were generated at the on-site inspection due to questionable level of director involvement or known location of the director in another state. They also considered the various infrastructures that exist in accredited facilities; the presence or absence of supporting, ancillary, or professional personnel in the facility, including cross-coverage of various functions among the clinical, collection, and processing staff members; and the impact of technology. The Task Force was not able to come to a consensus minimum number of hours or days that any director or medical director must physically be present in a facility to meet the standard.
Guidance for Remote Directors and Medical Directors
Responsibilities for remote directors do not differ from the responsibilities of any director, however, there may be more challenges in completion and documentation of these responsibilities. The following are requirements for remote directors:
- A director must be fluent in the language of the facility and must meet the minimum credentials, training, experience, competency, and continuing education requirements as defined in the current edition of Standards.
- A director is responsible to lead the accredited program, facility, or bank and to provide oversight of the services, personnel, products, and procedures.
- A director is expected to be actively engaged in the decision-making process, policy and procedure development, and quality management activities. This involvement must be documented.
- When a director is physically not present at the facility site, there must be a qualified designee named and documented to manage those responsibilities that require immediate or in-person attention. Further, all critical director functions must be covered.
- A qualified designee must meet minimum director qualifications for the delegated function, and have a defined scope of authority and activity.
- Specific responsibilities of each director and medical director type are defined in the applicable set of Standards and are summarized in the table below. Documentation of director involvement in these responsibilities must be available on-site for review.
Documentary evidence of the remote director’s specific involvement in leadership and oversight of the program, in addition to performance of designated responsibilities, must be available on-site for review by the inspector. Examples of documentation include, but are not limited to:
- Meeting minutes
- Record review
- Personnel review
- SOP review and approval
- Donor or recipient management
- Investigation report review
- Qualification/validation studies: plan and final report review and approval
- Planned deviation pre-approval
- Product release authorization
|Cellular Therapy Director Type||Applicable Standards (7th Edition)|
|Clinical Program Director||B3.1.3, B3.1.4, B3.1.5, B184.108.40.206, B4.1.1, B4.2.1, B220.127.116.11, B18.104.22.168, B4.13.3, B22.214.171.124, B4.17, B4.18, B5.3.8, B5.3.9, B5.7|
|Marrow Collection Facility Medical Director||CM126.96.36.199-CM188.8.131.52, CM5.3.8, CM5.3.9, CM5.7, CM7.2.2, CM7.2.3|
|Apheresis Collection Facility Director||C3.1.2, C4.1.1, C4.2.1, C184.108.40.206, C4.13.3, C220.127.116.11, C4.17, C4.18, C5.3.8, C5.3.9, C5.7, C7.2.2, C7.2.3|
|Apheresis Collection Facility Medical Director||C3.2.2, C18.104.22.168, C5.3.8, C5.3.9, C5.7|
|Processing Facility Director||D3.1.2, D4.1.1, D4.2.1, D22.214.171.124, D4.13.3, D126.96.36.199, D4.17, D4.18, D5.3.7, D5.3.8, D5.7, D7.2.2, D7.2.3, D8.1.1, D188.8.131.52, D8.7.1, D8.9, D11.1.1, D184.108.40.206, D220.127.116.11, D11.3.6, D18.104.22.168|
|Processing Facility Medical Director||D3.2.2, D4.9.4, D22.214.171.124, D5.3.7, D5.3.8, D5.7, D8.1.7, D8.10, D126.96.36.199, D188.8.131.52, D12.1.4|
|Cord Blood Director Type||Applicable Standards (6th Edition)|
|Cord Blood Bank Director||Appendix I, B2.11.5, B184.108.40.206, B220.127.116.11, B18.104.22.168, B22.214.171.124, B126.96.36.199, B2.13.1, B2.14.1, B188.8.131.52, B2.19, B3.2.3, B184.108.40.206, B6.2.5, B12.2, D6.4.2|
|Cord Blood Bank Medical Director||Appendix I, B2.11.5, B220.127.116.11, B18.104.22.168, B22.214.171.124, B126.96.36.199, B5.5.5, E4.2, E4.3.1|
|Cord Blood Collection Director||Cord Blood Collection Director|
|Cord Blood Processing Facility Director||Appendix I, B2.11.5, B188.8.131.52, D9.2.7|