FAHCT accreditation: Common deficiencies during on-site inspections

P. I. Warkentin, L. Nick, E. J. Shpall

Research output: Contribution to journalArticle

14 Scopus citations

Abstract

Background: The Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) was established in 1996 to develop and implement the inspection and accreditation program of the parent organizations, the International Society for Hematotherapy and Graft Engineering (ISHAGE) and the American Society of Blood and Marrow Transplant (ASBMT). Training of inspectors began in September 1996 and the first on-site inspections were conducted in September 1997. Methods: The process of attaining FAHCT Accreditation includes the assessment of written application materials against uniform accreditation criteria and an on-site inspection of each of the sites in the applicant hematopoietic progenitor cell (HPC) transplantation program. Observations at each inspection are recorded by the inspector on a checklist, reviewed by the FAHCT Accreditation Chairman and/or Technical staff, and presented to the FAHCT Board of Directors for review. Each observation is determined to be in compliance with Standards, a deficiency, or a variance. The deficiencies observed in these inspections were tallied following Board review and entered into an electronic database. Those deficiencies occurring in > 25% of the transplant programs reviewed are described below. Results: Significant deficiencies in the clinical programs included inadequate data management; incomplete or inadequate Quality Management Plan; and incomplete or absent standard operating policies and procedures. In the collection facilities, the most common significant deficiencies were incomplete or absent standard operating procedures; inadequate management of the results of donor evaluation findings and test results; lack of documentation of adverse reactions to collection; and deficiencies in the label applied to the HPC at the end of collection. Deficiencies in HPC laboratory services included validation procedures and/or records missing; ABO/Rh testing of the HPC component and/or comparison of the results with prior test results not done or documented; labels in use did not meet Standards; incomplete quality control documentation; HPC infusion documents not available, or in use; HPC storage policies and procedures incomplete; adverse reactions to HPC infusion not documented, or tracked; and engraftment not tracked by the laboratory. Discussion: Although all programs had a few too many deficiencies noted initially at the on-site inspection, 23 have successfully completed full accreditation. A few specific standards give problems to many programs. Participants, in general, believe the changes made in preparation for FAHCT accreditation have improved their HPC transplantation programs.

Original languageEnglish (US)
Pages (from-to)213-220
Number of pages8
JournalCytotherapy
Volume2
Issue number3
DOIs
StatePublished - Jan 1 2000

Keywords

  • Accreditation
  • Deficiencies
  • FAHCT
  • Inspections

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Oncology
  • Genetics(clinical)
  • Cell Biology
  • Cancer Research
  • Transplantation

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