| The use of blood and marrow cells for transplantation has evolved since World War II and today approximately 70% of all hematopoietic transplants are autologous. This evolution shifted the majority of care from a lengthy inpatient procedure to outpatient treatment. Strict standards for transplant care and personnel training are essential to prevent higher than expected mortality rates for this vulnerable patient population receiving outpatient care. The Foundation for the Accreditation of Cellular Therapy (FACT) is a voluntary accreditation program with standards based upon new developments in the field of cellular therapy. Any collection, processing, or transplant center that voluntarily applies for accreditation consents to operate in accordance with the standards outlined by FACT. This report presents the results of a formal process-based program evaluation of an existing blood and marrow transplant program. The purpose of this evaluation was to (1) determine facility compliance with national accreditation standards stipulated by FACT; (2) recommend new or policies, procedures, and processes, necessary to successfully participate in future FACT accreditation review; and (3) promote the highest quality medical and laboratory practice in blood and marrow transplantation. The 1,181 item FACT Inspection Checklist was completed through documentation review, observation, informal interviews with key organizational participants, and site inspection of the facility. Evaluation identified 94 items not applicable to the program, 694 items that met FACT standards, 312 total adjusted deficiencies and 12 variances. Prior to actual FACT inspection, standard operating procedures will have to be written and some will require updating. Prior to the inspection new or updated policies and procedures with documentation validating compliance should be implemented, and documentation validating that all items reviewed on the checklist are in compliance with FACT standards. |
