FACT Updates its Clinical Outcomes Corrective Action Plan Policy for Transplant Programs

Posted in :: 2022 Volume 6 :: Tuesday, December 20th, 2022

Clinical transplant programs accredited under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration have always been expected to follow and evaluate clinical outcomes of transplantation, including both individual and aggregate data. Since the sixth edition in 2015, Standards have also required that clinical outcomes be assessed against national or international outcome data, that program outcomes should meet or exceed national or international benchmarks, and that programs not meeting the expected range of survival must submit to FACT a corrective action plan (CAP).

In the United States, all allogeneic hematopoietic transplants must be reported to the CIBMTR. Since 2016, the current FACT process for review of clinical outcomes requires that Clinical Programs performing allogeneic transplants must meet the expected range of one-year survival as published in the CIBMTR Transplant Center-Specific Survival Report. If the one-year survival for first allogeneic transplants falls below the risk-adjusted expected range, the program must submit a CAP that is reviewed by the FACT Clinical Outcomes Improvement Committee. The Committee advises the Clinical Program, monitors implementation of the elements of the CAP, and follows the program’s internal data assessing the effectiveness of the CAP and improvements in survival.

The CIBMTR report published in December 2021 included first allogeneic transplants for the years 2017-2019. This was the first report in which all included years were within a timeframe in which the Clinical Outcomes Improvement Committee had been requesting and reviewing CAPs. This report presented an opportunity to evaluate the effectiveness of the Committee’s processes. The Committee reviewed data collated from CIBMTR reports, internal data submitted by Clinical Programs, and Committee determinations on the appropriateness and effectiveness of CAPs. It determined that the likelihood that a CAP will successfully improve one-year survival can be predicted by the duration of time in which the program’s risk-adjusted one-year survival was below the expected range, trends in survival rates based on the program’s internal data, and the ability and effort demonstrated by the program.

Based on this analysis, the FACT Board of Directors approved additional steps added to the Clinical Outcomes Corrective Action Plan Policy which include:

  • If the risk-adjusted one-year survival remains lower than the expected range and does not improve for three consecutive reporting years, the Clinical Outcomes Improvement Committee will formally evaluate in more depth the Clinical Program’s ability and effort to improve survival.
  • The Committee may determine that ability and effort are sufficient, that more time is required to demonstrate the required improvement, and/or that other contingencies exist.
  • If the Committee determines that the program has not demonstrated sufficient ability or effort, the program’s accreditation will be placed on probation. Probation is defined as a period of time during which a program has not met specific defined criteria and is at risk of losing FACT accreditation if additional requirements are not met. This status is documented in the program’s FACT application report and internal FACT records but is confidential and will not be published or released.
  • Programs on probation for clinical outcomes remain accredited but may be required to complete a focused reinspection. The scope of the reinspection will be based on the program’s specific deficiencies in evaluating and improving one-year survival. It is our experience that the intensified support provided by the Committee during the reinspection process leads to sustained improvement in survival.
  • The timing of the focused reinspection will be determined by the Committee, independent of the program’s normal accreditation cycle.
  • If the program does not demonstrate satisfactory correction of the deficiencies, the program’s accreditation may be suspended in accordance with FACT’s policy on Suspension or Termination of Accreditation. The Committee will determine the timeframe in which deficiencies must be corrected and one-year survival must improve. Failure to demonstrate correction of the deficiencies within the established timeframe may result in termination of the accreditation.

We note that the potential for accreditation suspension has always been a possible consequence for low one-year survival as published in the current version of the Clinical Outcomes Corrective Action Plan Policy; however, these changes provide a framework based on data in which the Clinical Outcomes Improvement Committee can formally make such a decision. The ultimate goal of FACT and Clinical Programs throughout this process is to improve outcomes for patients. We believe this process will improve patient survival.

For more details about the CIBMTR Transplant Center-Specific Survival Report, see the article published in November 2022 at https://news.factglobal.org/from-the-archives-understanding-the-cibmtr-outcomes-reports/.