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Related Experiment Videos

FAHCT accreditation: common deficiencies during on-site inspections.

P I Warkentin1, L Nick, E J Shpall

  • 1Foundation for the Accreditation of Hematopoietic Cell Therapy, Department of Pathology, University of Nebraska Medical Center, 982168 Nebraska Medical Center, Omaha, NE 69198, USA.

Cytotherapy
|June 4, 2002
PubMed
Summary

The Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) identified common deficiencies in hematopoietic progenitor cell (HPC) transplantation programs, including issues with data management and standard operating procedures. Despite initial challenges, many programs improved and achieved FAHCT accreditation.

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Area of Science:

  • Hematopoietic Cell Therapy
  • Transplantation Medicine
  • Quality Management in Healthcare

Background:

  • The Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) was established in 1996 by ISHAGE and ASBMT.
  • FAHCT developed an inspection and accreditation program for hematopoietic progenitor cell (HPC) transplantation programs.
  • Inspector training commenced in 1996, with the first on-site inspections in 1997.

Purpose of the Study:

  • To assess the common deficiencies identified during FAHCT accreditation inspections.
  • To analyze areas needing improvement in hematopoietic progenitor cell (HPC) transplantation programs.
  • To evaluate the effectiveness of the FAHCT accreditation process in enhancing program quality.

Main Methods:

  • Accreditation involved assessing written materials against criteria and conducting on-site inspections of HPC transplantation programs.

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  • Inspector observations were recorded on checklists and reviewed by FAHCT leadership.
  • Deficiencies were categorized as compliance, deficiency, or variance, and tallied for programs with over 25% occurrence.

    • Main Results:

    • Clinical programs frequently showed deficiencies in data management, quality management plans, and standard operating procedures.
    • Collection facilities had common issues with SOPs, donor evaluation, adverse reaction documentation, and labeling.
    • HPC laboratory services often lacked validation, proper ABO/Rh testing, compliant labeling, quality control, infusion documentation, storage policies, and adverse reaction tracking.

    Conclusions:

    • While initial inspections revealed numerous deficiencies, 23 programs successfully achieved full accreditation.
    • Certain standards consistently presented challenges across multiple programs.
    • Participants generally reported improvements in their HPC transplantation programs due to FAHCT accreditation preparation.