Corrective Action Strategies to Improve Care Dennis Gastineau, MD Mayo Clinic FACT President

FACT Benchmarking Requirement The Clinical Program should achieve one-year survival outcome within or above the expected range when compared to national or international outcome data. U.S. allogeneic programs: SCTOD report If expected one-year survival outcome is not met, the Clinical Program shall submit a corrective action plan. 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. Allogeneic programs in the U.S. must use the results from the transplant center-specific outcomes report published by CIBMTR for the SCTOD. If one year-survival expectations are not met, the program must submit a corrective action plan to FACT. At this point, accreditation will not be taken away if expected one-year survival is not met, but those programs undergo increased scrutiny regarding the actions they are taking to improve.

Clinical Outcomes Improvement Committee Michael Lill, MD (Chair) Cedars-Sinai Medical Center, Los Angeles, CA Fred LeMaistre, MD (Vice-Chair) Sarah Cannon, Nashville, TN Luke Akard, MD Indiana Blood and Marrow Transplantation Program, Indianapolis, IND Ahmad Samer Al-Homsi, MD Spectrum Health, Grand Rapids, MI Dennis Gastineau, MD Mayo Clinic, Rochester, MN George Selby, MD OU Medical Center, Oklahoma City, OK Amir Steinberg, MD Mount Sinai, New York City, NY Phyllis Warkentin, MD University of Nebraska, Omaha, NE The FACT Clinical Outcomes Committee is charged with assisting hematopoietic progenitor cell transplant programs with improving patient outcomes by providing resources, creating tools, and reviewing corrective action plans. It is geographically and academically diverse, and the members have many years of experience in BMT. Most, and possibly all, of the committee’s decisions have been unanimous.

Assistance to Transplant Centers Education has shown to be key Several workshops and webinars are offered Examples of corrective action plans to be displayed on website FACT, ASBMT, NMDP Education Consortium to consolidate resources Individualized attention appears to be necessary FACT Outcomes Committee identifies weaknesses in corrective actions, offers advice, monitors progress Staff frequently fields questions directly from programs FACT Consulting is a separate option Does not guarantee accreditation or improved outcomes, but can provide more intensive support The ultimate goal of FACT’s outcomes initiative is to improve clinical outcomes and patient safety. Assisting transplant centers is a major priority, and significant effort has been dedicated to do this. Education has shown to be key in this process. There is a lot that programs do not understand about the CIBMTR report, root cause analysis, or how to start. We have presented on this topic in workshops and webinars, and have several more educational events planned in the coming year. We are de-identifying plans we found to be excellent and will be posting them on the FACT website with those program’s permission. We are working with ASBMT and NMDP to consolidate educational resources targeted toward our different audiences, such as pharmacists, social workers, and referring physicians. Individualized attention appears to be an important component of outcomes improvement. FACT’s outcomes committee provides that attention by carefully reviewing submitted corrective action plans, identifying weaknesses and requesting additional information, offering high-level advice, and monitoring progress. One-on-one discussions between program representatives and FACT staff also helps. Although not required, FACT Consulting is an option for programs needing more intensive support. This does not guarantee accreditation or improved outcomes, but it is worth noting as an additional means to help programs identify areas needing improvement.

FACT Guidelines for Corrective Action Plans Must identify specific causes of death Must provide quantitative data Must identify reasonable causes of the low one-year survival rate Must address the identified causes. Must be a measurable outcome improvement. Must provide updates at time of inspection, annual reporting, and as otherwise directed by committee The FACT Clinical Outcomes Improvement Committee reviews corrective action plans submitted by Clinical Programs not meeting expected one-year survival. Creation and review of these corrective action plans is new to programs and new to FACT. One of the most common weaknesses initially seen was the tendency to jump to conclusions without really looking at actual causes of deaths. Initial inadequate plans did not provide us any data or evidence of what had been considered. After several months of reviewing corrective action plans, the committee articulated its expectations using six guidelines. Since providing these guidelines to programs this summer, submitted plans have shown improvement. [Explain guidelines]

Perceived roadblocks to corrective actions Needed clarifications Getting Past the Myths Perceived roadblocks to corrective actions Needed clarifications High-risk patients High risk is not a cause of death; look at the specifics Small programs Good-faith effort will provide insight into cause of death Confidence interval Each program has its own interval; all can succeed Delay in reporting Upward trajectories in survival over time considered Broad endpoint Only overall one-year survival is provided, but programs are responsible for drilling down into data Data errors Corrective actions related to data management and reporting expected if this is a problem High-risk patients: Some plans stated the root cause of death to be transplants for high-risk patients. The CIBMTR report is risk adjusted and high-risk patients are accounted for within the report. FACT expects corrective actions that specifically addresses the causes of death. Broad refusal to transplant patients with high risk is not the intent of FACT requirements. For example, some programs have determined that myeloablative therapy was not necessary or beneficial for a group of frail patients; another adjusted its protocol for preparative regimens. Small programs: It is difficult to identify trends among a small number of transplants, but FACT will look for a good-faith effort of the program to review data and determine if a trend can be found. One small program found that its patients had a high rate of CNS disease, and is educating its network of referring physicians. Confidence interval: A common worry is that Clinical Programs will have one-year survival lower than the expected range, through no fault of their own, because of the 95% confidence interval. However, each program has its own confidence interval. A defined number does not have to drop out of the curve. Therefore, it is possible for each program to meet expected one-year survival. Small programs typically have a wider range of expected outcomes. Delay in reporting: Since the CIBMTR report is delayed by two years and uses three years’ worth of data, programs think the opportunity to improve has been lost. However, it is still necessary to review the causes of death and their root causes for the timeframe of the report. If survival is showing an upward trajectory since that year, that information can be included in the corrective action plan for consideration. Overall one-year survival: The CIBMTR report provides overall one-year survival; however, drilling down into specific diseases will help Clinical Programs determine root causes and which corrective actions may help. This is the same for treatment-related mortality or disease relapse. Data errors: Some programs noted errors in data submitted to the CIBMTR that were the true root of one-year survival. Indeed, this can affect the results of the algorithm. If data errors are a problem, FACT wants to see corrective actions related to accurate data management and reporting. A good example of this will be posted on our website, and FACT and CIBMTR are collaborating on a data improvement initiative.

Example Corrective Actions Decrease time from diagnosis to transplantation Education of referring physicians Physician-specific dashboards Use of HCT-CI Increase in and training of data management staff Modifications to treatment algorithms and donor selection strategies Use of haploidentical transplants Allogeneic patient clinic staffed by NP and pharmacist Patient education program Psychosocial assessments This slide lists a few examples we’ve seen in corrective action plans. There is a wide variety of ideas, and we are finding that is appropriate given the unique situations of each program. The FACT committee accepts corrective action plans if the plans reasonably address the specific causes of death identified through root cause analysis. We will soon be receiving updates from programs on the effectiveness of these plans.

4 of these first had to submit improvements to FACT 16 programs have corrective action plans considered satisfactory for proceeding 4 of these first had to submit improvements to FACT 5 programs must provide FACT additional information to confirm adequacy of plan Expecting to see updates on effectiveness of corrective actions beginning in November 2016 This chart shows the current status of corrective action plans we’ve received. There have been a total of 21 programs that have submitted corrective action plans, and three-quarters of those plans have been found satisfactory at this point. Some of those plans first had to be resubmitted with additional data or more description of corrective actions planned. There are five programs that are currently working to improve their plans, and this improvement must be seen before renewal accreditation will be awarded. Once a plan is considered satisfactory, programs are instructed to provide FACT an update on the corrective actions that were implemented and the effectiveness of those actions. If not effective, we will expect new ideas to be put forth in the plans. We should be receiving our first updates in November and look forward to seeing the progress programs have made.

Conclusions Programs need continued education about what the one-year survival data means and the importance of identifying specific causes of death. The FACT process is encouraging programs to take specific steps to improve and is providing guidance on how to do so. Updates over the next six months will inform us of the effectiveness of the corrective action plans.