FACT Resources to Assist Your Program Throughout the Accreditation Process

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT aims to provide organizations with valuable resources to aid in achieving and maintaining their accreditation. Our website has useful documents for organizations in all phases of the accreditation process. However, we understand that finding the right information can become overwhelming at times especially for organizations completing their initial application or for personnel new to the accreditation process.

The following overview provides categories, definitions, and the location of important resources. We encourage you to share this information with all personnel involved in your organization’s FACT accreditation process:

FACT Standards

The FACT Standards webpage contains links to the most recent versions of the four sets of Standards published by FACT:

  • HCT StandardsFACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
  • Common StandardsCommon Standards for Cellular Therapies
  • Immune Effector StandardsStandards for Immune Effector Cells
  • Cord Blood Bank StandardsNetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration

The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:

  • FACT Standards and Accreditation Manuals
  • Summary of Changes, Compare, and Crosswalk documents to identify changes between the previous and current versions of FACT Standards, if applicable.
  • Forms used during the compliance application submission, including but not limited to Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.

 The above resources can also be found in the Cellular Therapy Library and Cord Blood Bank Library.

Accreditation Process Requirements

The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements provide a structured overview of the accreditation process, from completing the Compliance Application to requirements after the on-site inspection.

Self-Assessment Tools

The Self-Assessment Tools can be used to assess readiness for FACT accreditation. They are located in the Cellular Therapy (CT) and Cord Blood Bank (CB) Libraries, and you will find individual self-assessment tools for each current set of FACT Standards:

Educational Resources

FACT’s comprehensive, robust training and development program is responsive to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. With a focus on real-life examples and practical application, FACT educational sessions provide tools not only for achieving accreditation, but for ensuring quality patient care in accordance with the Standards. The Education and Resources page contains links to upcoming and previously recorded events:

FACT Accreditation Coordinator

FACT’s Accreditation Coordinators provide these and additional FACT resource links in an email sent to organizations at the beginning of the compliance application process. Your accreditation coordinator is available throughout the accreditation process to answer questions via email or phone. The coordinator’s contact information is available in the accreditation portal.

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. The Clinical Outcomes Resource Center includes comparative data sources, educational resources, guidelines for corrective action plans (CAP), as well as CAP examples.

Data Management Resource Center

The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. The Data Management Resource Center provides CIBMTR and educational resources, guidelines for data management submissions and examples, and audit report examples and templates.

Immune Effector Cells (IEC) Resource Center

FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for blood and marrow transplantation and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. The Immune Effector Cells (IEC) Resource Center includes resources to assist with understanding immune effector cells and implementing applicable FACT Standards.

Portal Resource Center

The Portal Resource Center provides access to all available resources and training materials for navigating and assisting organizations in completing applications in the portal.

FACT News

Use the links below to access recent news releases, as well as current and previous volumes of our newsletter:

We hope that you find this information useful as you prepare for your next accreditation cycle. If you have additional suggestions regarding how FACT can better inform organizations of the resources available, please email fact@unmc.edu.


Biology of Blood and Marrow Transplantation Publishes Article on FACT Clinical Outcome Review Process

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

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


Trending Clinical Outcomes

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

By: Kara Wacker, MBA,  FACT Strategic Planning Administrator

Clinical outcome analysis might have started gaining renewed attention in recent years, but FACT has required such analysis since its first Standards in 1996. This puts the HPC transplant field at an advantage as more stakeholders and patients are evaluating health care institutions in the context of actual clinical outcomes. Transplant programs that have voluntarily complied with FACT Standards over the years have outcome data that can be useful not just for retroactive investigations but for anticipating lower-than-expected outcomes in the future . . . and addressing them before undesirable outcome trends result.

When programs are required to submit a corrective action plan to address lower-than-expected one-year survival (per the FACT-JACIE Hematopoietic Cellular Therapy Standards), a common question asked of FACT is, “what time frame should my plan address?” The time frame should include current data, but should also go back in time far enough to detect any trends.

For example, autologous-only or non-U.S. programs often use the C.W. Bill Young Cell Transplantation Program’s U.S. Patient Survival Report or the Be the Match/NMDP Disease-Specific HCT Indications and Outcomes Data as comparative data sources. These reports are by year, but a single year is not long enough to adequately evaluate outcomes to detect problems.

Some allogeneic programs in the U.S. assume the time frame is limited to that used in the Transplant Center-Specific Survival Report published annually by the Center for International Blood and Marrow Transplant Research (CIBMTR). These time frames consist of three calendar years, with the last year being two years prior to report publication. The FACT Clinical Outcomes Improvement Committee does expect that these years be included; however, programs are not limited to this time frame. In fact, survival from before the time frame in the CIBMTR report will help programs detect when a declining trend began. Data from years following the CIBMTR report illustrate a complete picture of the current survival rates of the program, and can be used to determine effectiveness of corrective actions. Such data should readily be available from internal outcome analyses required by the Standards. They can also be obtained from CIBMTR’s Data Back to Centers (eDBtC) resource.

A FACT-accredited program shared a trending tool with FACT, and gave us permission to anonymously make it available to other programs on the FACT website. This Microsoft Excel-format Risk and Non-Risk Adjusted Survival Data and Box Graph has fields for entering figures from multiple CIBMTR reports over time (such as number of first-transplant patients, risk-adjusted survival, and endpoints of the expected range), plus non-risk adjusted one-year survival rates from internal data or eDBtC. After inputting this data, a graph on the second sheet is automatically populated.

An example is below. In this example, the program met clinical outcomes in both the 2013 and 2014 cohorts (2009-2011 and 2010-2012, respectively). However, the program’s survival rate declined. By the next report in 2015, the program did not meet expected one-year survival. As a program’s risk-adjusted actual survival declines and gets closer to the lower limit of the 95% confidence interval, it can begin evaluating causes of death of its patients and implementing corrective actions before one-year survival becomes lower than expected.

If survival rates are declining, questions a program may want to ask include:

  • Is there a difference in causes of death, or have any specific causes increased?
  • Did disease/patient case mix change?
  • Are protocols still being followed?
  • Are there any changes in psychosocial patterns?
  • Do records adequately follow patients?
  • Do protocols need updated to current science?

Programs often fall in and out of expected survival ranges, and they should monitor how close their survival rate is to the lower limit. Avoid complacency just because survival was within the expected range; make a genuine effort to robustly complete required internal outcome analyses to detect problems before the CIBMTR report does. After all, we all know the real goal isn’t a score of “0” on the report. It is improving patient survival.


Evaluating Causes of Death to Improve Survival

Posted in :: 2018 Volume 4 :: Tuesday, November 6th, 2018

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.


Resources Continuously Added to FACT Website

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

Topics include clinical outcomes, immune effector cellular therapy, patients and families, and more

To support FACT-accredited organizations and the FACT mission to improve cellular therapy, resources are continuously added to the FACT website. This article highlights just a few of the informational webpages that provide links to journal articles, instructions, examples, and more.

Clinical Outcomes

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. This page includes links to comparative data sources (especially helpful to autologous-only and non-U.S. programs), educational resources, and example corrective action plans. The page also lists the guidelines for corrective action plans for quick reference.

Immune Effector Cells

The main objective of FACT’s Immune Effector Cell Standards is to promote quality practice in immune effector cellular therapy. FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for bone marrow transplant and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. Resources include FACT Standards for Immune Effector Cells, educational on-demand webinars, frequently asked questions, and journal articles. Examples of guidelines and procedures used by organizations for managing immune effector cell programs and patients will soon be available.

Patients and Families

Education and assistance for cellular therapy patients and their families are key to promoting desirable clinical outcomes. Direct links to a variety of organizations and informational sources are listed for several topics, including donor registries, information and support, cord blood banking and donation, and clinical trials and access to cell therapies.

Quality Management

Although quality management is relatively new to cellular therapy programs and cord blood banks,  the principles of quality assurance and quality control have long been incorporated. For the FACT accreditation process, the real turning point for emphasis on quality management activities was with the release of the third editions of the Cellular Therapy Standards and Cord Blood Standards, which included greatly expanded Quality Management sections. Since that time, FACT has developed and introduced quality-based educational materials to assist your organization with developing and enhancing your Quality Management Program.


Establishing Efficiencies Between IND Requirements and FACT Standards

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

Many FACT-accredited cellular therapy programs participate in clinical trials, and awareness of such activities has become more pronounced with the advent of FACT’s new voluntary accreditation for immune effector cellular (IEC) therapy. Most IEC products are administered under Investigational New Drug, or IND, requirements.

There are some FACT requirements that are not typically required of INDs but could greatly enhance research, such as a quality management program, accessible procedures, and training.  Likewise, some typical IND requirements could be used to also satisfy FACT requirements, and documentation created to comply with IND requirements can be used.

Outcomes

FACT requires outcome analysis, which is also performed in accordance with IND requirements. The program does not need to gather and report its own independent data if this is already performed by the investigator and shared with the program.  This could be demonstrated through minutes from a quality meeting where outcomes were reviewed, or within signed outcome analysis reports. The key is that outcome information is reported back to the accredited center’s Quality Management (QM) program in some fashion to allow assessment of program performance (such as personnel training and competency or needed procedural improvements).

Product efficacy based on patient outcome may be difficult to document for novel cellular therapy products, and that assessment will differ for each product type. Predefined outcome criteria for investigational cellular therapy products (e.g., CAR T-cells, vaccines) may be found in the clinical research protocol and may include clinical outcomes or only safety endpoints, depending on the trial phase. Data from each investigational product does not need to be aggregated in total; for example, IECs vary widely in cell type, manipulation, protocol, and indication. However, data regarding similar products may shed important light on process improvements within the control and discretion of the program (protocols must be strictly followed per IND requirements).

Reporting of outcome data also advances the field. FACT Standards recommend that Clinical Programs collect each of the data elements contained in the applicable CIBMTR Cellular Therapy forms or EBMT forms. Use of the actual form and submission to CIBMTR or EBMT is not required unless dictated by applicable laws and regulations. FACT strongly recommends the publication of data and strongly encourages the submission of data to the CIBMTR. In the event that the Clinical Program does not submit data to these registries, it should provide reasonable explanations for not doing so. Examples of the forms currently utilized by the CIBMTR may be found on the organization’s website at http://www.cibmtr.org.

Audits

Similar to outcome analysis, audits are typically performed as directed by INDs and the results of those audits can satisfy FACT Standards if they are forwarded to the QM Program for review. If an IND does not require an audit, then an audit as required by the Standards must take place.

Policies and Procedures

Many programs utilize IND protocols to satisfy FACT requirements for SOPs.  At a minimum, programs should have a local, high-level SOP that describes the big picture of the activities to perform. Actual protocols could be referenced and made available to staff, or the detailed procedural steps could be outlined in job-specific SOPs. Some manufacturers have very specific SOPs and provide them to programs, and, in these cases, there is no need to copy the SOP over to the program’s format. However, protocols are not a no-fail way of meeting the intent of the standard.  Programs should ensure that the protocols include specific details for staff performance without being burdensomely long, that they are accessible to staff, and that training on the protocols has been performed.


Autologous and Non-U.S. Survival: Ideas for Comparative Data Sources

Posted in :: 2016 Volume 2 :: Wednesday, October 12th, 2016

Unlike allogeneic transplants in the U.S., there is no risk-adjusted report of one-year survival for autologous transplants. There are a variety of risk-adjusted survival registries around the globe, but not for every region. Yet Clinical Programs are expected to benchmark their survival to comparative data and take corrective action. One of the most common questions we receive from autologous-only or non-U.S. programs is, “Where do we find data on one-year survival for autologous transplants?”

The FACT-JACIE Hematopoietic Cell Therapy Standards do not prescribe any specific data source to use for autologous benchmarking. The following are ideas to consider:

C.W. Bill Young Cell Transplantation Program

  • S. Patient Survival Report: The U.S. Patient Survival Report displays an estimate of the number of patients who are alive after a bone marrow or umbilical cord blood transplant. The estimates are shown:
    • By disease and length of time after transplant (including one year)
    • By the type of donor who provided the cells for transplant:
      • Autologous (the patient’s cells)
      • Related allogeneic (a patient’s sibling or another family member’s cells)
      • Unrelated allogeneic (a volunteer donor’s cells)
    • The cells used for transplant (bone marrow, peripheral blood, or umbilical cord blood)

Be the Match/National Marrow Donor Program

  • Disease-Specific HCT Indications and Outcomes Data: The outcomes data presented here are based on more than 50,000 unrelated donor transplants NMDP facilitated, plus autologous and allogeneic transplant data reported to CIBMTR® (Center for International Blood and Marrow Transplant Research). This CIBMTR data and analysis are based on more than 330,000 patients from U.S. and global transplant programs.

Peer-reviewed Medical Literature

  • Scholarly articles examining multi-center one-year survival using relevant disease, donor type, and date range.

Understanding the CIBMTR Outcomes Reports

Posted in :: 2016 Volume 2 :: Wednesday, October 12th, 2016

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 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 explains the report methodology in the document titled, Methodology Employed for Annual Report on Hematopoietic Cell Transplant Center-Specific Survival Rates. The document provides technical information on statistics, but offers the following summary: “A 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/ethnicity; Karnofsky/Lansky score; coexisting disease (Sorror HCT-CI); recipient CMV status; disease/status; interval from diagnosis to transplant (ALL and AML only); NHL subtype; resistant disease (NHL and HL only); CLL and other chronic leukemia stage; prior autologous transplant; year of transplant; donor type/graft type/HLA matching; donor/recipient gender match (bone marrow or PBSC only); and donor age (unrelated donor bone marrow or PBSC only). The report on transplant center-specific survival rates helps to identify centers that may have performed above or below confidence limits compared to the overall network of transplant centers . . .”

CIBMTR also explains the report, and its tools and resources to help Clinical Programs use their data, in the 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 make 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 stated 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; 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. 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 range of expected outcomes.
  • 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 2012 that resulted in lower-than-expected one-year survival in the 2015 report. 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, include that information in the corrective action plan for consideration.
  • 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 low 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 reporting.

Guidelines for Corrective Action Plans to Improve Low One-Year Survival

Posted in :: 2016 Volume 2 :: Wednesday, October 12th, 2016

The FACT Clinical Outcomes Improvement Committee reviews corrective action plans submitted by Clinical Programs not meeting expected one-year survival. Development and review of these corrective action plans is new to Clinical Programs and to FACT. The emphasis of the committee is to help programs identify ways to improve their outcomes for patients, and it appreciates the programs who submitted the first plans and provided more information when requested. After several months of reviewing corrective action plans, the committee has articulated its expectations for these plans using six guidelines:

  • The corrective action plan must identify specific causes of death.
  • The corrective action plan must provide quantitative data.
  • The assessment must identify reasonable causes of the low one-year survival rate.
  • The corrective action plan must address the identified causes.
  • There must be a measurable outcome improvement.
  • The program must provide updates on corrective actions at the time of inspection, at the time of annual reporting, or as otherwise directed by the committee.

The essential point of these guidelines is to help Clinical Programs write corrective action plans that convey the thought process they employed to identify root causes and implement remedial measures. It is tempting to jump to conclusions and take actions assumed to be beneficial, but those actions will not be effective if incorrect conclusions are made. By providing quantitative data about causes of death, it will be clear to both the program and the FACT committee what the underlying issues are and where opportunities for improvement exist.

FACT will continue to provide advice and examples related to improving clinical outcomes. The next Quality Management Series module is dedicated to Outcome Analysis, and will consist of four webinars from November through February that focus on clinical outcomes. Example corrective action plans, used with permission from Clinical Programs, will also be posted on the FACT website this fall.