Just the FACTs, Volume 10
Have you finished your holiday shopping yet? I cannot believe the year has gone by so quickly.
This month’s central theme of data management and its importance is crystalized by the potential penalty of poor CIBMTR audit outcomes and potential impact on accreditation. Why is “just data” so important to accreditation? Well, without correct data, no program or program director can know what is going on in the program beyond gut feel (and we know how that works out . . .). The correct data is not merely to ensure CIBMTR has good data for research, it is so each program can be performing effective ongoing self-analysis for continuous improvement of the care of patients and outcomes. Therefore, it is time to ensure that everyone in the program is participating in the quality of information, from the clinical note, to abstraction, to understanding the questions and categories for CIBMTR. That alone takes a teamwork of providers and data managers.
FACT continues to expand its Regenerative Medicine activities and note the article on Advanced Therapies Week in January.
A big thank you to all who performed their first inspections this year—keep recruiting your colleagues! We have some new programs for supporting and educating inspectors to ensure everyone feels comfortable going out for that first inspection, and resources to access before, during, and after the inspection. Keep it up!
Sincerely,
Dennis Gastineau
President of FACT
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.
FACT Announces Cord Blood Inspection and Accreditation Workshop at the 2020 ISCT Annual Meeting, Paris
FACT Cord Blood Inspection and Accreditation Workshop
Tuesday, May 26
8:00 am – 5:00 pm
This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. Inspector trainees have required assignments to complete before attending the workshop. In order to attend this track, you must be pre-approved as an inspector trainee.
Apply to train as a FACT inspector. If approved, you can attend the workshop FREE of charge! Eligible Cord Blood Bank personnel are encouraged to serve as a volunteer FACT inspector and enjoy the following value-added benefits:
Exposure to Exemplary Practices
As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas. Interaction with inspection team members also provides the opportunity to network and collaborate.
Professional Development
Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on a curriculum vitae.
Influence
Inspectors have influence over FACT policies and requirements. Input from FACT inspectors is sought in the process of developing new editions of Standards.
Free Access to FACT Educational Resources
As a volunteer, you will have free access to both in-person and online educational events with an annual value over$1,800.
Information about qualifications and how to apply to become a FACT inspector can be found on the FACT website. If you have any questions, please contact Mikaela VanMoorleghem or the FACT office.
Are you ready?
Publication of the NetCord-FACT International Cord Blood Standards, Seventh Edition
FACT is pleased to announce the publication of the Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration on October 15, 2019. The Standards will become effective on January 15, 2020. Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the NetCord-FACT Cord Blood Standards Committee on publishing the new edition of Cord Blood Standards.
Committee Overview
The Seventh Edition NetCord-FACT Cord Blood Standards Committee is comprised of one steering committee, three subcommittees, and a total of 30 representatives. The standards development process commenced in January 2018. The committee’s commitment, expertise, and experience is invaluable to the development of these Standards.
The Standards contain important additions and changes to requirements to reflect current processes typical in a cord blood bank. These changes maintain the relevance of the Standards in the cord blood field.
Accessing the Standards and Other Resources
To improve your experience on our website, the FACT Standards webpage was updated with the Cord Blood Standards, accompanying Accreditation Manual, and other associated documents. These are available to download for free at: http://www.factwebsite.org/cbstandards/. Printed copies can be purchased online at the FACT Store.
There is a new tool highlighting the changes. A redlined compare document highlighting edits from the 6th to 7th edition is now available.
Accreditation Services
FACT Accreditation Services notified cord blood banks affected by the new edition prior to publication to discuss the transition. We understand the effort required to complete the accreditation process and are ready to assist banks with timely submission of compliance applications in accordance with the new edition of Standards.
If you have additional questions, please contact your FACT Accreditation Coordinator.
FACT is a Proud Partner of Advanced Therapies Week
Advanced Therapies Week, which will take place January 20-24, 2020 in Miami, Florida, will raise public awareness and support innovation in advanced therapies. Its organizer, Phacilitate, initiated this global campaign in conjunction with the Regenerative Medicine Foundation to support three areas:
- Public engagement
- Technology innovation
- Workforce development
The week will begin with a public day on January 20 at the renowned Frost Science Museum, during which interactive “activation” tables will allow members of the public to immerse themselves in concepts related to advanced therapies.
From January 21-24, the Phacilitate Leaders World and World Stem Cell Summit conferences will offer a comprehensive program with diverse tracks that address many aspects of advanced therapies – from raising capital and streamlining manufacturing processes to clinical delivery to patients. As a partner of Advanced Therapies Week, FACT participated in the development of the agenda and encourages the cellular therapy community to attend. Phacilitate has generously extended a 15% discount off the registration fee to the FACT community. To take advantage of this offer, enter the discount code FACT15 when prompted by the online registration process.
FACT will host the second Regenerative Medicine InterCHANGE on January 24, the last day of Advanced Therapies Week. During this meeting, attendees nominated by and representing organizations involved in cellular therapies will discuss solutions to the challenges identified with the development, testing, and commercialization of novel cellular therapies. In 2018, 17 organizations with complementary missions discussed specific challenges and created a list of action items based on their related initiatives. This year, over 30 organizations with broad perspectives of novel cellular therapies are invited to discuss progress on those action items and form working groups for challenges not yet addressed.
Advanced Therapies Week will also include programming for women in advanced therapies, stem cell and regenerative medicine action awards, advanced therapies 101 for the nursing professional, and a yacht party to celebrate advances in the field. The International Society Cell & Gene Therapy (ISCT), one of FACT’s parent organizations, will also be hosting a Commercialization Signature Series event.
Learn more about Advanced Therapies Week
Register for the Phacilitate Leaders World and World Stem Cell Summit conferences
Remember to enter FACT15 for a 15% discount.
Congratulations to Our New Inspectors!
The following individuals completed their first active inspection between November 2018 through October 2019. Congratulations and thank you for volunteering your time and expertise to advance cellular therapy! Organizations with personnel who also serve as FACT inspectors typically perform better during on-site inspections than their counterparts without an inspector. If you are interested in serving as an inspector, submit an online application! For a complete list of active FACT inspectors, view the online list of FACT Inspectors.
Rona Weinberg, PhD
Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
New York Blood Center Clinical Apheresis and Cellular Therapy Laboratory, New York
Sandy Ward, MS, BSMT
Processing: minimal manipulation of HPC
Sarah Cannon Blood and Marrow Transplant Program
Suzanne Thibodeaux, MD, PhD
Apheresis Collection
Stem Cell Transplant Program at Barnes-Jewish Hospital and St. Louis Children’s Hospital at Washington University School of Medicine
Dunia Jawdat, PhD
Cord Blood Banking, Cord Blood Collection, Cord Blood Processing
King Abdullah International Medical Research Center Cord Blood Bank
Basem William, MD, MRCP, FACP
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, Marrow Collection
The Ohio State University Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Michael Sun, MS, SCYM(ASCP)
Processing: minimal manipulation of HPC
Thomas Jefferson University Hospitals – The Sidney Kimmel Cancer Center Blood & Marrow Transplant Program
Mary Ann Kelley, MT(ASCP)BBCM
Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
Dana-Farber Cancer Institute / Cell Manipulation Core Facility
Marco Garcia, MLS(ASCP), MS
Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
University Hospitals Seidman Cancer Stem Cell Transplant Program
Scott Koepsell, MD, PhD
Apheresis Collection, Processing: minimal manipulation of HPC, Processing: more than minimal manipulation of any cell type
University of Nebraska Medical Center/Nebraska Medicine Hematopoietic Cell Transplantation Program
Daniel Gibson, BSc (Hons) LIBMS
Cord Blood Collection, Cord Blood Processing
The Anthony Nolan Cord Blood Bank
Benjamin Tomlinson, MD
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy
University Hospitals Seidman Cancer Stem Cell Transplant Program
Sarita Joshi, MBBS, MD
Clinical Hematopoietic Cellular Therapy, Apheresis Collection
Seattle Cancer Care Alliance
FACT Education Events
FACT – Héma-Québec – Liège Cord Blood Bank Cord Blood Webinar in Support of World Cord Blood Day
November 14, 2019
10:00 am ET, 15:00 GMT, 16:00 CET
In anticipation of World Cord Blood Day, FACT, along with Héma-Québec and Liège Cord Blood Bank, invites you to attend a special Cord Blood webinar on Thursday, November 14, 2019 at 10:00 am ET, 15:00 GMT, and 16:00 CET. The purpose of this webinar is to better understand immunogenetic diversity in registries and cord blood banks, as well as cord blood transplantation and emerging pathogens. This webinar is free of charge and will be presented in French. Slides will be available in both English and French. Topics include:
• Immunogenetic Diversity in Registries and Cord Blood Banks: Dr. Eliane Gluckman
• Cord Blood Transplantation and Emerging Pathogens: Is there reason for concern? Dr. Gilles Delage
• Personal experience from a cord blood recipient
FACT also encourages you to join the Save the Cord Foundation on November 15 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.
Instructions for joining the FACT Webinar on November 14:
1. Log into webinar:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Enter your name and email. Click “Join Now.”
3. If requested, enter the event number: 666 195 982
4. Adjust computer audio to desired volume.
_____________________________________________
French Translation
En préparation de la Journée Mondiale du Sang de Cordon Ombilical, nous vous invitons à participer à un séminaire en ligne spécial qui aura lieu jeudi le 14 Novembre 2019 à 10:00 HNE, 15:00 GMT, and 16:00 CET. L’objectif de ce séminaire est de mieux comprendre la diversité immunogénétique dans les registres et les banques de sang de cordon, ainsi que les agents pathogènes émergents dans le cadre de transplantation. Ce séminaire est gratuit et sera présenté en Français. Les diapositives seront disponibles en français et en anglais.
Liste des sujets:
• Diversité immunogénétique dans les registres et banques de sang de cordon: Dr. Eliane Gluckman
• Transplantation de sang de cordon et pathogènes émergents: est-ce un sujet d’inquiétude? Dr. Gilles Delage
• Expérience personnelle du receveur d’une greffe de sang de cordon.
FACT vous encourage également à vous joindre à la Fondation Save the Cord le 15 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations pour le grand public ainsi que des présentations académiques par des chercheurs et des médecins transplanteurs réputés sur les récentes avancées et thérapies utilisant le sang de cordon ombilical.
1. Se connecter au séminaire:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Saisir votre nom et adresse email. Cliquer “Join Now.”
3. si demandé, entrer le numéro de l’événement: 666 195 982
4. Ajuster le volume de votre ordinateur au niveau désiré.
FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm
We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!
This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.
Register for the FACT workshop
FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm
Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.
Register for the FACT Leadership 101 course
FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm
If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.
Register for the FACT Advanced Leadership 201 course
FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm
Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.
Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.
Register for the FACT-ASTCT Quality Boot Camp
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm
The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, from 5:00 pm to 7:00 pm.
Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This 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.
Register for the FACT Global Affairs session
FACT Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.
Apply to train as a FACT inspector. If approved, you can attend the workshop FREE of charge!
Register for the FACT workshop
