FACT, ASTCT, CIBMTR, ISCT, and EBMT Publish Joint Statement Against Racism

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

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

Posted in :: 2019 Volume 11 :: Monday, November 25th, 2019

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

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

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

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


New Volunteer Committee Members

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

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.

    • 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.

    • 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

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

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

Posted in :: 2019 Volume 2 :: Tuesday, February 12th, 2019

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

Posted in :: 2018 Volume 4 :: Tuesday, November 13th, 2018

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

Posted in :: 2018 Volume 4 :: Thursday, November 8th, 2018

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

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.


Data Management Resources Serve as Gateway to Improving Reporting

Posted in :: 2018 Volume 3 :: Tuesday, August 21st, 2018

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

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

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.