Register for the 2023 AcCELLerate Forum: Join in Person or Virtually
ASTCT™, CIBMTR® and the National Marrow Donor Program®(NMDP)/Be The Match® are excited to announce that registration is now open for the 2023 AcCELLerate Forum!
Participate in person or virtually in impactful conversations regarding patient needs, therapies, and access to cell and gene therapy with advocates, industry representatives, researchers, and providers. Together we will identify needs and opportunities in the field for advocacy and sustainability.
Preliminary agenda topics include:
- 80/20 Updates
- Access and Care Disparities in Cellular Therapy
- Cost-Mitigating Approaches in Cellular Therapy
- Future Directions in Cellular Therapy
- Histocompatibility Impact on Safety and Efficacy
- Logistics for Cell Therapy Delivery in Different Settings
- Point-of-Care Manufacturing and Production
- Regulatory Process for Approving New Products
View the up-to-date agenda (subject to change)
Follow #accellerate23 for updates
From the Archives: Understanding the CIBMTR Outcomes Reports
The publication of the 2022 CIBMTR Transplant Center-Specific Survival Report is expected in December 2022. To help Clinical Program Directors prepare to evaluate their programs’ results, this volume’s From the Archives feature is, “Understanding the CIBMTR Outcomes Report,” published in October 2016.
Many of the concerns outlined in this article are still presented to FACT today, and we added more information and updated references to address recent questions. Our hope is that increased understanding of the CIBMTR report will transform its reputation as an anxiety-inducing evaluation into a reputation for what it is meant to be: one of many resources available to transplantation programs to understand and improve one-year survival.
There are many great Just the FACTs newsletter articles related to clinical outcomes, and it was difficult to choose! To see more helpful articles about clinical outcomes, click here.
Happy reading!
Understanding the CIBMTR Outcomes Reports
Allogeneic transplant programs in the U.S. are required to submit corrective action plans to FACT when they do not meet the expected range of one-year survival in the annual CIBMTR Transplant Center-Specific Survival Report. To adequately assess lower-than-expected one-year survival, it is necessary to fully understand how the report is generated.
CIBMTR reviews its methodology for the Center-Specific Survival Report every other year at the Center Outcomes Forum. This forum includes a variety of stakeholders, including transplant physicians, and is intended to also increase transparency and understanding. The agendas and summaries of each meeting can be found on the CIBMTR website. CIBMTR also explains the report methodology in the document titled, Methodology Employed for Annual Report on Hematopoietic Cell Transplant Center-Specific Survival Rates, which was last updated in December 2021. The document provides technical information on statistics, but offers the following summary:
“A fixed effects censored data logistic regression model is fitted to survival data for first unrelated and related donor hematopoietic cell transplants at U.S. centers. The model is adjusted for recipient age, recipient race, Karnofsky/Lansky score, Sorror HCT-CI, adult BMI group, pediatric BMI group, recipient CMV status, history of mechanical ventilation, history of invasive fungal infection, prior autologous transplant, disease/stage, AML ELN risk group, AML transformed from MDS or MPN, AML therapy related, number of induction cycles for AML in CR1, interval from diagnosis to transplant in ALL and AML in CR2 and CR3+/relapse, ALL cytogenetic risk group, Philadelphia positive-status in ALL, number of induction cycles for ALL in CR1, MDS IPSS-R risk score at HCT, MDS predisposing condition, CLL and other chronic leukemia disease status, NHL subtype, sensitivity to chemotherapy in NHL and HL, MM ISS stage at diagnosis, plasma cell disorder disease status, year of transplant, donor type/graft type/HLA matching, BM or PBSC donor/recipient sex match, unrelated BM or PBSC donor age at transplant, and recipient median household income. The report on transplant center-specific survival rates helps to identify centers that may have under-performed or over-performed compared to the overall network of transplant centers during this specified time period.”
Each year, CIBMTR provides a comprehensive version of the Center-Specific Survival Report directly to programs prior to publishing the results on the Be the Match website. The report is usually provided to programs annually in mid-December. In each of these reports, CIBMTR outlines in detail the risk factors that are considered and ultimately included in the final multivariate model used to produce the report that year. Each report includes sections on methods, statistical analysis, and results that describe how the model is formulated. Not only does this provide context for individual programs’ results, but it also provides information that any program can use regarding factors that have had a statistically significant impact on one-year survival.
CIBMTR also explains the report, and its tools and resources to help Clinical Programs use their data, during a 2016 FACT webinar recording titled, Using CIBMTR Data to Determine and Evaluate Clinical Outcomes, presented by Stephen Spellman, MBS. This recording gives an overview of how CIBMTR data is used to determine outcomes and how Clinical Programs can use additional data to further evaluate outcomes and improve.
The following are common points Clinical Programs question about the CIBMTR report, and how they can be evaluated in the context of creating corrective action plans to address lower-than-expected one-year survival:
- High-risk patients: Some corrective action plans state the root cause of death to be transplants for high-risk patients. As outlined above, the CIBMTR report is risk-adjusted. High-risk patients should be accounted for within the report. The FACT committee expects corrective actions that specifically address the causes of death. Broad refusal to transplant patients with high risk is not the intent of FACT requirements. As transplants are often the last hope for patients, careful attention to trends in causes of death is particularly important for these patients to improve their outcomes. For example, some programs have determined myeloablative therapy was not necessary or beneficial for a group of frail patients; others adjusted their protocol for preparative regimens.
- Socioeconomic factors: Some programs are located in regions in which their patients have a low socioeconomic status. Social factors do have an impact on a patient’s survival, and FACT understands that these factors are difficult to include in a risk-adjusted methodology. In these cases, FACT would expect to see a corrective action plan that targets social issues identified to be a root cause of patient deaths. Programs have implemented methods to successfully address low resources and lack of caregivers, such as pre-discharge dispensing of prescription medications, bus passes, and expanded clinic hours.
- 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 educated 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. It is important to realize that 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 expected survival range.
- Delay in reporting: Due to the inherent timeframe of “one-year” survival, the CIBMTR report is delayed by two years because the transplant has to have occurred a year prior, and an additional year is needed to analyze the data. Furthermore, the report uses three years’ worth of data. For example, data analysis may show that a Clinical Program had a particularly bad year in 2019 that resulted in lower-than-expected one-year survival in the 2021 report. That year will affect one-year survival in the next two reports for 2022 and 2023. However, it is still necessary to review the causes of death and their root causes for the timeframe of the report. Programs must submit current internal survival data as part of their corrective action plans. Upward trajectories of internal data are taken into account.
- Overall one-year survival: The CIBMTR report only 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. This type of drill-down has helped programs identify root causes.
- Data errors: Some Clinical Programs have noted that errors in the data submitted to the CIBMTR were the true root of lower than expected one-year survival. Indeed, this can affect results of the algorithm. If data errors are a problem, FACT will want to see corrective actions related to accurate data management and evidence that these corrections have had an impact on the risk-adjusted survival.
Transforming Data into Knowledge: How Sarah Cannon Analyzes Risk-Adjusted and Unadjusted Survival Outcome Trends and Projections
By Therese Dodd, BA, MBA, RN, CPHQ, FNAHQ
Quality and Accreditation/Regulatory Compliance Specialist
Transplant & Cellular Therapy Network
Sarah Cannon
1100 Dr. Martin L. King, Jr. Blvd, Suite 800, Nashville, TN 37203
The centers of Sarah Cannon Transplant & Cellular Therapy Network (SCTCTN) are not alone in their need to understand clinical outcomes, the definitive outcome being patient survival. It falls to the centers to transform an abundance of data into knowledge for performance improvement.
The Center for International Blood & Marrow Transplant Research (CIBMTR®) Transplant Center-Specific Survival Report provides survival data to eligible hematopoietic cell therapy (HCT) centers for first allogeneic transplants for a three-year period to at the end of each calendar year. The report displays a “–1” in the performance status column for centers whose actual survival is lower than the 95% confidence limits for predicted survival, a “1” if performing above the confidence limit, and a “0” if performing as predicted. The SCTCTN centers recognized that reading the report is just a first step. One challenge to understanding the survival results is that these reports only display the information from preceding years as a table (see example in Figure 1). Supplying information to centers in this manner may provide them a false sense of confidence if they do not trend the specific outcomes results. In the figure 1 example, the “-1” assigned in the 2015 report may have been an unpleasant surprise if the center wasn’t rigorously analyzing its clinical outcomes internally.
The SCTCTN centers have created box graphs, similar to the Excel template available on the FACT website in the Clinical Outcomes Resource Center, to track the clinical outcomes from the CIBMTR® Transplant Center-Specific Survival Report . As can be seen in Figure 2, there was a decline in actual % 1 year survival for transplants performed during 2010-12, dropping from greater than the % predicted survival in the previous report to lower than % predicted survival and approaching the lower limit of the 95% confidence interval.
With the 2011-13 report, the 95% confidence interval increased, which indicates lower-risk patients were transplanted. Since the report is risk-adjusted, there was an expectation that patient survival would increase; however, the % actual survival was worse than the lower limit of the 95% confidence interval. Fortunately, the center had already started root cause analysis and identified several opportunities for improvement including, but not limited to, increasing data abstraction and entry accuracy, strengthening survivorship programs, and expanding caregiver support services. The center was able to improve its clinical outcomes by the time of the subsequent report.
Figure 2.
In addition to tracking data from the CIBMTR® Transplant Center-Specific Survival Report, the SCTCTN have overlaid a trend line to the box graphs (see black dotted line in Figure 2) of actual % survival using data from the CIBMTR® enhanced data back to centers (eDBtC). Based on experience, and not surprisingly, SCTCTN centers determined that the eDBtC % actual survival for first allogeneic transplants tracked closely to the CIBMTR® report data year over year. Because of this, the centers can determine an estimate that is prognostic for the actual % survival in the upcoming report by finding the % survival at 12 months using the CIBMTR® eDBtC “Survival Probability – HCT” functionality (see Figure 3).
Figure 3
In addition to annual analysis of the CIBMTR® Transplant Center-Specific Survival Report, the SCTCTN centers monitor actual autologous and allogeneic hematopoietic cell transplant (HCT) % 30-day, 100-day, and 1-year survival and treatment-related mortality in smaller timeframe cohorts on a quarterly basis and more concurrently. Tracking these data (as well as many other quality and outcome metrics) supports rigorous quality management programs that improve the experience for SCTCTN patients.
FACT, ASTCT, CIBMTR, ISCT, and EBMT Publish Joint Statement Against Racism
Racism has no place in our society and profession. The American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), Foundation for the Accreditation of Cellular Therapy (FACT), the International Society for Cell & Gene Therapy (ISCT), and the European Society for Blood and Marrow Transplantation (EBMT) all find these acts of racism reprehensible and inexcusable. This cannot be ignored any longer by the global community and our respective organizations.
We stand for the advancement of innovative, life-saving medicine. We know the importance of moving the needle forward in order to enact positive, powerful change. When it comes to issues of racism and violence, we realize the need for change, too.
We recognize that racism is an institutional problem in health care, and we are committed to doing our part to bridge that gap. We stand behind those who promote equality, diversity and inclusion. As a health care community, we have to do better—for not only the patients we serve, but the communities they live in as well.
As we work toward improving diversity and denouncing racism in health care and cities around the world, we commit to having the important conversations and supporting critical initiatives within our community that move us toward equality both in the transplantation, cellular and gene therapy workforce and in access to lifesaving therapies.
Please use this resource from the National Museum of African American History & Culture to educate yourself on the importance of talking about race and to find tools on combating racism in your own communities. We ask that you stand with us in denouncing racism and violence.
CIBMTR Infection and Immune Reconstitution Working Committee Outlines Challenges and Progress
FACT and the Center for International Blood and Marrow Transplant Research (CIBMTR) collaborate in a variety of ways to use the power of data to improve patient care within individual transplant programs and the field as a whole. The FACT-CIBMTR Data Audit Committee evaluates corrective action plans (CAPs) for data management in the context of CIBMTR data audit results. The FACT Clinical Outcomes Improvement Committee evaluates CAPs for clinical outcomes, including when risk-adjusted one-year survival does not meet the expected range of the CIBMTR Transplant Center-Specific Survival Report.
Infection data are an important part of both of these efforts. Cause of death is a critical field within CIBMTR’s on-site data audits. Infection is one of the most commonly reported causes of death reported to FACT in clinical outcome CAPs.1 This data is a complex field to report but could hold the key to many ideas to improve patient survival following transplantation.
Fortunately, there is a committee for that. According to the website, cibmtr.org, “The CIBMTR Infection and Immune Reconstitution Working Committee provides scientific oversight for studies about prevention and treatment of post-transplant infections and issues related to recovery of immune function.”
This working committee recently published an update of its challenges and progress in the CIBMTR newsletter. This update provides statistics about infection-related deaths and issues that make the collection of infection data complicated and demanding. The CIBMTR committee also extended its appreciation to data managers for providing the committee with the high-quality data it needs to do its important work. (Please send their thanks to your data management team!) Finally, the committee closed its article with a list of manuscripts that may help your program improve patient survival. We encourage you to take advantage of the knowledge gleaned from the work of this expert committee of physicians and statisticians, made possible by the data you all submit.
1LeMaistre, C.F., Wacker, K.K., Akard, L.P., Al-Homsi, A.S., Gastineau, D.A., Godder, K., Lill, M., Warkentin, P.I. (2019). Integration of Publicly Reported Center Outcomes into Standards and Accreditation: The FACT Model. Biology of Blood and Marrow Transplantation, 25, 2243-2250. https://doi.org/10.1016/j.bbmt.2019.06.035
Data Audit Policy Update
FACT-JACIE Standards for Hematopoietic Cellular Therapy require that accredited clinical programs keep complete and accurate data, including all data necessary to complete the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A forms of EBMT.
In August 2016, FACT and CIBMTR announced their collaborative program of data auditing, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited programs. Over the past three years, the FACT-CIBMTR Data Audit Committee has reviewed corrective action plans related to data accuracy and has provided individual assistance to programs for performing data audits and for reporting and submitting audit results. In addition, the Committee developed the Data Management Resource Center to assist all programs and to ensure that education offered by FACT and CIBMTR is readily available.
Recently, FACT announced a revision to its Data Audit Policy to link CIBMTR Data Audit results to FACT accreditation. To be compliant with Standard B9, a clinical program will be expected to meet the CIBMTR passing benchmark of ≤ 3.0% critical field error rate at its on-site CIBMTR Data Audit.
- Programs with >3.0% critical field error rate will have failed the CIBMTR Data Audit and be required to submit corrective action plans and follow up reports to the FACT-CIBMTR Data Audit Committee to maintain their FACT Accreditation.
- Following a second consecutive CIBMTR Data Audit failure, the program’s FACT accreditation may be suspended. Reaccreditation will require a passing CIBMTR Data Audit and may require a reinspection by FACT.
- No program’s accreditation will be immediately impacted. The FACT Accreditation Data Audit Consequences Policy began October 1, 2019. Results from CIBMTR data audits performed after October 1, 2016 apply to this policy.
- Each FACT-accredited Clinical Program has been individually notified of its current status, including guidance for required actions.
- Refer to the FACT Data Audit Policy for additional details.
This change coincides with the CIBMTR Audit Policy, and aligns FACT and CIBMTR consequences according to the same timeline. The CIBMTR processes for submission of corrective action plans addressing systemic errors, milestone report requirements, and management of informed consent issues will not change.
Complete and accurate data are critical for self-assessment in individual cellular therapy programs, for research and outcomes reporting, and for compliance with FACT-JACIE Standards. Improvements in data accuracy will enhance the quality of clinical care and laboratory services for the benefit of patients. FACT and CIBMTR are committed to working with programs to improve data accuracy through internal audits and corrective action plans as appropriate to successfully complete CIBMTR audits and maintain continuous FACT accreditation.
Biology of Blood and Marrow Transplantation Publishes Article on FACT Clinical Outcome Review Process
The journal Biology of Blood and Marrow Transplantation (BBMT) has electronically published the article, Integration of Publicly Reported Center Outcomes into Standards and Accreditation: The FACT Model (LeMaistre et al, 2019). Combining historical information with aggregate data collated from corrective action plans (CAPs) submitted to FACT, the article provides an overview of FACT’s process for evaluating one-year survival and preliminary themes found in CAPs.
The full abstract states:
“The rapid evolution of Blood and Marrow Transplant (BMT), coupled with diverse outcomes associated with heterogeneous groups of patients, led to the formation of two important organizations early in the development of the field: the Center for International Blood and Marrow Transplant Research (CIBMTR) and the Foundation for the Accreditation of Cellular Therapy (FACT). These organizations have addressed two of the nine elements identified by the National Quality Strategy (NQS) [1] for achieving better health care, more affordable care, and healthy people and communities: first, a registry that promotes improvement of care and, second, accreditation based on quality standards. More recently, a federally-mandated database in the United States addresses the third element of the NQS: public reporting of treatment results.
This paper describes the current process by which FACT incorporates patient outcomes reported by the CIBMTR into standards for accreditation, the requirements for accredited programs whose performance is below expected outcomes to maintain accreditation, and preliminary findings in assessing corrective action plans intended to improve outcomes.”
The paper is a useful reference for understanding FACT requirements for evaluating one-year survival, generating ideas for outcome analyses within transplant programs, and understanding the value of setting expectations for patient outcomes within the context of voluntary accreditation programs.
LeMaistre, C.F., Wacker, K., Akard, L., et al. (in press). Integration of publicly reported center outcomes into standards and accreditation: The FACT model. Biology of Blood and Marrow Transplantation. doi: 10.1016/j.bbmt.2019.06.035
New Volunteer Committee Members
Annually, FACT distributes a Call for Volunteers to solicit new committee members for its Standing and Special Committees.
The FACT Board of Director strives to have a 20% turnover each year in committee membership to provide new opportunities for those interested in becoming more involved with FACT as well as to interject fresh and innovative perspectives in working groups.
It is always moving to see the numbers of volunteers willing to devote their personal time in light of increasingly busy schedules. Although there are typically not enough positions available to place all volunteers on a committee, we retain the information of volunteers to appoint to committees in subsequent years.
Following are the FACT Committees that had vacancies this year and their new members:
Education Committee
Purpose: To develop education and training programs for inspectors and for personnel at applicant and accredited facilities to promote knowledge and understanding of current standards, create awareness of commonly cited deficiencies, and promote quality in cellular therapy.
- Nicole Acqui, MD
- Alex Babic, MD, PhD
- Guy Klamer, PhD
- Yogesh Jethava, MBBS
- Premal Lulla, MD
- Joseph Lynch, MD
- Huy Pham, MD, MPH
- Priti Tewari, MD
Quality Management Committee
Purpose: Develop and administer programs that maintain high quality in FACT’s organizational operations and in accredited programs.
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- Sylvia Dulan, RN, MSN, MBA, PMP –
- Kris Michael Mahadeo, MD, MPH
- Omotayo Fasan, MBBS, MRCP
- Krista Holcomb
FACT-CIBMTR Data Audit Committee
Purpose: Coordinate the evaluation of transplant center data audits performed by FACT and CIBMTR.
-
- Jaskiran Kaur, CQA(ASQ)
- Linh Sellers, CCRP
- Hemant Murthy, MD
Technology Committee
Purpose: Enhance, refine, streamline, and improve the efficiency of the accreditation process and educational programs through the continued improvement of Technology and FACT’s online presence.
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- Leon Su, MBA, FCAP, FASCP
- Shanlong Jian, BS, MS
- Federerico Rodriguez Quezada BSMT, SBB(ASCP)
The contributions of our volunteer committee members has been invaluable and has resulted in the tremendous success of FACT. Thank you to all our volunteers for your dedication and support of FACT to ensure quality patient care, improve treatment outcomes, and foster continue development in the field of cellular therapy.
FACT Events at the 2019 TCT Meetings Were a Success
FACT hosted several popular events at the 2019 TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR in Houston, Texas. Over 150 people joined FACT on February 19 for the Cellular Therapy Inspection and Accreditation Workshop, which included topics such as building quality into clinical immune effector cell programs, risk evaluation and mitigation strategies, using the Tracer Methodology to assess compliance with standards, common citations, reviewing clinical outcomes, and improving data management through follow-up. Also on February 19, FACT hosted two cellular therapy leadership courses for anyone who has, or aspires to, a leadership position in cell therapy.
On February 20, FACT teamed up with ASBMT to host the 4th annual Quality Boot Camp. Over 130 people participated in the boot camp. This year’s agenda focused on topics such as dashboards and scorecards, record retention, risk assessment, integrating IECs into your HCT program, and evaluating the quality of your program through auditing. Quality experts presented core concepts, led roundtables, and answered questions to help others reach their quality management goals.
Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 21. The FACT Global Affairs: International Accreditation session provided attendees information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.
On February 21, in the session titled, Quality in HCT: Center-Specific Outcomes, Dr. Dennis Gastineau, FACT President and member of the FACT Clinical Outcomes Improvement Committee, shared guidelines for corrective action plans, and trends noted in the plans reviewed, including causes of death, challenges in root cause analysis, and ideas for improving one-year survival.
On February 22, FACT hosted a social hour for all FACT inspectors and inspector trainees in honor of their dedication and service provided to the cell therapy community. FACT relies on volunteer inspectors and appreciates their superior service, time, and expertise.
In addition to these events, FACT welcomed visitors to its exhibit booth to provide information about accreditation and educational activities.
All events were successful and FACT looks forward to the 2020 Transplantation and Cellular Therapy Meetings in Orlando, Florida!
FACT welcomed 150 attendees to the Cellular Therapy Inspection and Accreditation Workshop at the 2019 TCT Meetings.
Call for FACT Volunteers
Dear FACT Colleague:
The Foundation for the Accreditation of Cellular Therapy has several committees to help FACT achieve its vision of being the premiere organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.
In light of your experience and important involvement with the FACT inspection and accreditation process, we invite you to review the charges for the committees with current vacancies and either nominate yourself or a colleague to serve as a committee member.
Education Committee
Purpose: To develop education and training programs for inspectors and for personnel at applicant and accredited facilities to promote knowledge and understanding of current standards, create awareness of commonly cited deficiencies, and promote quality in cellular therapy.
Responsibilities:
– Attend monthly one-hour teleconference
– Develop content for workshop and webinar presentations
– Assess effectiveness of training events and recommend improvements
– Serve as a FACT workshop presenter at various meetings
– Develop content for inspector continuing education
Quality Management Committee
Purpose: Develop and administer programs that maintain high quality in FACT’s organizational operations and in accredited programs.
Responsibilities:
– Attend monthly one-hour teleconference
– Maintain and update the FACT Quality Management Handbook
– Offer a comprehensive schedule of webinars related to quality management activities
– Develop content for quality “boot camps”
– Develop quality metrics for gauging the performance of the FACT inspection and accreditation process, including effectiveness, efficiency, and customer satisfaction
FACT-CIBMTR Data Audit Committee
Purpose: Coordinate the evaluation of transplant center data audits performed by FACT and CIBMTR.
Responsibilities:
– Attend monthly one-hour teleconference
– Develop mechanisms by which CIBMTR and FACT can coordinate audits and inspections of data management processes within transplant centers
– Develop a collaborative approach to evaluate the results of FACT inspections with CIBMTR’s data audit findings to ensure a coordinated response to the transplant center
– Participate in the joint FACT-CIBMTR data review process by assessing programs’ progress on implementing corrective action plans
– Develop education and provide assistance to programs throughout the accreditation cycle to achieve quality improvement in data management
Technology Committee
Purpose: Enhance, refine, streamline, and improve the efficiency of the accreditation process and educational programs through the continued improvement of technology and FACT’s online presence.
Responsibilities:
– Attend quarterly one-hour teleconference
– Suggest ideas to enhance user’s experience using the Accreditation Portal
– Evaluate and review new portal features
– Evaluate new technologies to improve business processes
– Interface with other committees to identify data needs to develop and publish reports
– Evaluate a mobile app option for FACT’s resources such as Standards, announcements, newsletter, and education
Please submit your interest in serving as a committee member along with a description of your qualifications to Linda Miller at lmiller1@unmc.edu by March 1, 2019.
The contributions of our volunteer FACT inspectors and committee members have been invaluable and have resulted in the tremendous success of FACT. Thank you for your dedication and support of this important effort to ensure quality patient care, improve treatment outcomes, and foster continue development in the field of cellular therapy.
Sincerely,
Dennis Gastineau, MD
President
Linda Miller, MPA
Chief Executive Officer
President’s Letter
FACT committees have advocated for cellular therapy organizations on several fronts this past quarter, and we are seeing results.
The Technology Committee, with the hard work of FACT’s IT Business Analyst, Alisa Forsythe, launched the new FACT Accreditation Portal on October 1st. Organizations and inspectors were candid with their feedback on the online accreditation process, and the committee and Alisa listened and were responsive to those needs. We are pleased to deliver a faster, more streamlined portal that better serves our stakeholders.
Rapid development and recent commercialization of novel cellular therapies have brought new protocols and processes to accredited organizations. The FACT Immune Effector Cell Task Force is advocating for clear, manageable, and sustainable expectations of programs that have begun providing immune effector cell therapies. The FACT Regenerative Medicine Task Force has been sharing related lessons learned with organizations working to advance regenerative medicine in order to address challenges upfront. We also continue to facilitate open communication via the Professional Relations Committee, comprised of several related organizations.
Our work with the Center for International Blood and Marrow Transplant Research (CIBMTR) and one of our parent organizations, the American Society for Blood and Marrow Transplantation (ASBMT), continues on important issues, especially data management and clinical outcomes. The FACT-CIBMTR Data Audit Committee and the Clinical Outcomes Improvement Committee have been focusing on clear articulation of expectations of accredited programs, while also working to promote quality data and outcomes improvement in a manner that is least burdensome and most effective for those programs.
The Global Affairs Committee has been traveling the globe and continues to do so in an effort to bring quality hematopoietic progenitor cell transplants to more patients. In addition to accreditation workshops in conjunction with several international meetings, FACT recently formalized a joint accreditation program in Brazil.
The Standards, Education, and Quality Committees have been busy updating Standards and continuing educational programming to assist accredited organizations with staying current in developments in the field. These efforts are integral to the practical implementation of FACT requirements.
Finally, we are immensely appreciative of the Cellular Therapy and Cord Blood Accreditation Committees, chaired by Phyllis Warkentin, MD, FACT Chief Medical Officer. As all of the committees above continue their good work, growth in the accreditation program follows. The number of cellular therapy programs seeking voluntary accreditation continues to grow, giving the Accreditation Committee more reports to review, discuss, and assess. These reports are also growing in complexity as programs provide more diverse services to their patients, and the committee has been prudent with considering these complexities and maintaining consistency in its reviews. Members of the Cellular Therapy Accreditation Committee have committed to additional time to accommodate the increasing number of reports, demonstrating their commitment to FACT’s mission of quality cellular therapy.
We welcome your participation in FACT’s peer review and accreditation, as an inspector and as a committee member.
Sincerely,
Dennis A. Gastineau, MD
FACT President
Data Management Resource Center Available on FACT Website
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews a program’s most recent CIBMTR data audit results including implementation of the corrective action plan (CAP), adequacy of the CAP, and effectiveness of CAP. The committee’s goal is to provide education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
To assist programs, the FACT-CIBMTR Data Audit Committee developed a Data Management Resources Center. This center contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
Evaluating Causes of Death to Improve Survival
Evaluating one-year survival, and the impact of efforts to improve survival, are challenging tasks for both FACT and accredited Clinical Programs. Hematopoietic progenitor cell (HPC) transplantation itself is complex before considering the confounding variables and unique patient characteristics required for outcome analysis. Many programs’ corrective action plans hint at a common struggle – where to start?
Risk-adjusted measures will always have weaknesses. Data definitions are necessary but can be rigid. Socioeconomic and geographic characteristics often have an impact but are difficult to measure. The sickest of patients needed alternatives, too. It is easy to feel that a program’s performance against comparative, risk-adjusted data is somewhat out of its control.
The FACT Clinical Outcomes Improvement Committee suggests programs start with cause of death, in a very literal sense. Identification of specific causes of death serves as a starting point for investigation. A quantitative, data-driven approach prevents inaccurate assumptions, especially in emotionally-charged situations. For example, high-risk patients need alternatives and programs may choose to approve them for transplant. By looking at causes of death, programs can focus on improvements within their control, such as risk-stratified approaches to choosing preparative regimens to address deaths caused by transplant-related mortality.
For U.S. allogeneic transplant programs, cause of death reporting is subject to rules set by the Center for International Blood and Marrow Transplant Research (CIBMTR). CIBMTR provides an easily accessible Forms Instruction Manual at http://www.cibmtr.org/manuals/fim. Among many subjects in this online manual, the CIBMTR lists rules for cause of death codes. There are several training and educational resources, also, and can be found on CIBMTR’s Training and References webpage. (For resources on the broader topic of the CIBMTR and FACT joint data audit program, visit FACT’s Data Management Resource Center.)
Clinical Programs are also encouraged to use internal data for outcome analysis. Internal cause of death data is not just helpful, but important. There are often contributory, secondary causes of death in addition to the primary cause. For example, a pediatric program may have a high rate of deaths caused by multi-organ failure, contributed by infection related to a high proportion of patients transplanted for an immunodeficiency. Programs may seek not only improvements in infection control, but also take actions to shorten the time to transplant or use granulocyte transfusion protocols.
Cause of death data can make the path toward outcome analysis and improvement clearer. Such data prevent incorrect assumptions, are available to both large and small programs, and provide a starting point for the complex process of evaluating one-year survival. Thank you for your efforts to improve survival of transplant recipients, and we will continue to share lessons learned via the FACT accreditation process.
Data Management Resources Serve as Gateway to Improving Reporting
By Heather Conway, FACT Quality Manager
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews each program’s most recent CIBMTR data audit results including implementation, adequacy, and effectiveness of the corrective action plan (CAP). The committee’s goal is to provide education and assistance to cellular therapy programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
Since its inception, the committee has provided extensive guidance and assistance to programs regarding data management, audit, and quality improvement principles. Using this experience, the committee created a Data Management resources area to assist programs. Programs are encouraged to review this information, which contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
The FACT-CIBMTR collaborative data audit process was formed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited transplant programs. The program intensifies support and improvement of data management and reporting processes, and these new resources support these efforts. In addition to the website, view previous newsletter articles about the program:
FACT and CIBMTR Announce Joint Data Audit Program
The Role of Medical Records During On-Site Clinical Program Inspections
The Role of Medical Records During On-Site Clinical Program Inspections
Last year, FACT and CIBMTR announced their collaborative data assessment program, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited Clinical Programs. Not only has this program intensified support and improvement of Clinical Programs’ data management and reporting processes, it saves time for programs audited by CIBMTR by reducing the need to make Transplant Essential Data (TED) forms and source documentation available to FACT inspectors during the on-site inspection.
Despite the reduction in records to produce for the data audit, there is still a critical need for access to medical records during on-site inspections. Compliance with many standards can be verified through medical records including:
- Donor and recipient informed consent;
- Donor eligibility evaluation and determination;
- Compliance with established policies, procedures, and guidelines;
- Verification of preparative regimens and recipient identity against protocols;
- Detection, evaluation, reporting, correction, and prevention of adverse events and other occurrences; and
- Verification of corrective action plan implementation.
Pre-selected and organized medical records facilitate inspector review. Pre-select records that represent a variety of situations applicable to your program, including:
- Allogeneic, autologous, and haploidentical transplants;
- Transplants using cells derived from peripheral blood, bone marrow, and cord blood;
- Cellular therapy using novel products such as immune effector cells (IECs);
- Adult and pediatric patients; and
- Adverse events, positive microbial cultures, and ineligible donors. (Yes! Showing inspectors medical records that represent less than ideal, but inevitable, circumstances will improve the results of your inspection by allowing inspectors to verify compliance with all standards.)
(A note about electronic medical records (EMR): Because it takes time to navigate electronic systems, it will also take time for the inspector to become familiar with your EMR. Create printed shadow charts and/or plan to navigate the system for your inspector. It is a good idea to communicate with your inspector in advance regarding his/her preferences.)
With the time saved by eliminating the need to produce accessible copies of TED forms, spend time selecting medical records from a variety of situations, evaluate your processes and make improvements where necessary. Use this opportunity to show your inspector how you continuously improve your program. That is, after all, the real purpose of FACT accreditation.
