Clinical Outcomes Resource Center

FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. FACT requires programs to submit a corrective action plan when one-year survival does not at least meet expected outcomes as demonstrated in comparative data. Several resources are available to assist programs with identifying trends in cause of death, the root causes, and corrective and preventive actions.

Comparative Data Sources

The following are acceptable data sources for benchmarking one-year survival:

U.S. Allogeneic Programs
CIBMTR Transplant Center-Specific Survival Report

Autologous Programs and Non-U.S. Programs
Stem Cell Therapeutic Outcomes Database HCT Trends and Survival Data

Be the Match/NMDP Disease-Specific HCT Indications and Outcomes Data

Country or region-specific registries

Peer-reviewed Medical Literature

Educational Resources

FACT QM Series Module 7: Outcome Analysis

FACT Inspection & Accreditation Workshops

ASTCT Committee on Quality Outcomes

Guidelines for Corrective Action Plans

The FACT Clinical Outcomes Improvement Committee reviews corrective action plans using specific criteria.

CAPs must:

• Identify specific causes of death.
• State current 100-day and 1-year overall and treatment-related mortality based on internal outcome analyses.
• Provide quantitative data.
• Identify reasonable causes of the low one-year survival rate.
• Address the identified causes.

Updates to the CAP must be submitted at the time of inspection, at the time of annual reporting, or as otherwise directed by the committee. These subsequent submissions must:

• Update quantitative data provided in the initial CAP.
• Provide any additional information requested by the Clinical Outcomes Improvement Committee.
• Include a timeline of implementation of corrective actions.
• Include an assessment of the corrective actions' effectiveness. Demonstrate a measurable outcome improvement, or, if outcomes do not improve, a reassessment of root causes and appropriate corrective actions based on the reassessment.

Examples

Allogeneic Corrective Action Plans

• Allogeneic 1
• Allogeneic 2
• Allogeneic 3
• Allogeneic 4

Autologous Corrective Action Plan

• Autologous 1

Templates

• Risk and Non-Risk Adjusted Survival Data and Box Graph
• Survival Trending Tool