By Heather Conway, FACT Quality Manager
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews each program’s most recent CIBMTR data audit results including implementation, adequacy, and effectiveness of the corrective action plan (CAP). The committee’s goal is to provide education and assistance to cellular therapy programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
Since its inception, the committee has provided extensive guidance and assistance to programs regarding data management, audit, and quality improvement principles. Using this experience, the committee created a Data Management resources area to assist programs. Programs are encouraged to review this information, which contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
The FACT-CIBMTR collaborative data audit process was formed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited transplant programs. The program intensifies support and improvement of data management and reporting processes, and these new resources support these efforts. In addition to the website, view previous newsletter articles about the program:
The FACT-JACIE Hematopoietic Cell Therapy Standards state, “If the intended recipient has received high-dose therapy, the cellular therapy product shall be transported.” (CM10.3.2, C10.3.2, D10.7) Some have asked what the purpose of this standard is because a product always needs to be distributed to the recipient.
The key word in this standard is “transported.” As stated by the FACT-JACIE definitions in Part A of the Standards, “transport” is the physical transfer of a cellular therapy product within or between facilities during which it does not leave the control of trained personnel at the transporting or receiving facility. In other words, someone who is trained to transfer a product must be with it at all times. This is in contrast to shipping, during which the product does leave the control of trained personnel (such as shipment on a commercial distributing company’s truck or airplane).
If a patient has undergone high-dose marrow ablative treatment in preparation for transplant, the cellular therapy product is essential for the patient’s survival since it may not be possible to obtain additional marrow or blood from the original donor or a second donor in time to prevent complications from aplasia. For this reason, it is important that the product be entrusted to a knowledgeable individual who accompanies it from the distributing facility to the receiving facility.
The Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA) surveyed cell processing facilities worldwide to elicit information about their training and competency assessment programs. Because these programs are critical to the safety of hematopoietic progenitor cell (HPC) products, the survey results are a resource to facilities to establish and maintain a competent workforce.
Results were published in Cytotherapy in Training practices of cell processing laboratory staff: analysis of a survey by the Alliance for Harmonization of Cellular Therapy Accreditation (Taylor, Slaper-Cortenbach, et al, Dec 2015, doi:10.1016/j.jcyt.2015.08.006). Respondents to the survey represented a diverse set of processing facilities and answered questions related to their facility type, location, activity, personnel, and methods used for training and competency.
Data from the survey illustrated a variety of training and competency methods, with some being more common than others. The results may help processing facilities with establishing or improving their training and competency programs.
The American Society for Apheresis (ASFA), in collaboration with the American Society for Clinical Pathology (ASCP), now offers a new credential in apheresis medicine.
The Qualification in Apheresis (QIA) is offered through ASCP and follows the Hemapheresis Practitioner (HP) and Apheresis Technician (AT) certifications. QIA certification expands credentialing for apheresis medicine professionals. There are specific eligibility routes that must be satisfied, including an eligibility route for international professionals.
The 50-question exam covers six areas: Basic Science; Clinical Applications; Donor/Patient Care; Instrumentation; Operational Considerations; and Standards, Guidelines, and Regulations. The qualification is valid for three years, and requalification requires participation in continuing education.
For more information on eligibility routes and available resources, visit the Qualification in Apheresis (QIA) page on the ASFA website.