SITC Requests Feedback on Immune Effector Cell-Related Adverse Events Guideline

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

Comments due by September 11, 2020

The Society for Immunotherapy of Cancer (SITC) announced a public comment period on its upcoming clinical practice guideline, The Society for Immunotherapy of Cancer consensus statement on immune effector cell-related adverse events. Comments are due by the end of September 11, 2020.

This manuscript is part of the SITC Cancer Immunotherapy Guidelines program, which is a collection of clinical practice guidelines available in the open-access, peer-reviewed online journal, Journal for ImmunoTherapy of Cancer (JITC). It was written by an expert panel that included representatives from the American Society of Hematology (ASH), the American Society for Transplantation and Cellular Therapy (ASTCT), and the Foundation for the Accreditation of Cellular Therapy (FACT).

Instructions for accessing the draft manuscript


Upcoming Educational Events

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

FACT Immune Effector Cellular Therapy Inspection and Accreditation Workshop at SITC Annual Meeting
Thursday, November 9, 2017
National Harbor, MD
This training workshop is designed to educate participants on two key perspectives: building quality into their immune effector cell programs and performing peer-based inspections. FACT’s mission is to improve the quality of cellular therapy programs and depends on volunteer experts to visit programs and assess their compliance with the Standards. This peer-review approach keeps FACT accreditation credible, relevant, and useful. Attendees will learn about the mission of FACT, principles of FACT Standards, the accreditation process, and basic inspection techniques.

Registration is free for current inspectors and approved inspector trainees. Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements. To apply to become an inspector, submit an online application.

View meeting details and register online

WMDA-NetCord Webinar: Manual and Automated Methods for Thawing of Cord Blood
Wednesday, November 29, 2017
Webinar

This WMDA-NetCord webinar is November 29, 2017, at 11:00 ET. Cellular therapy departments must thaw cord blood units, and they often use very different processes from the procedures outlined by the cord blood bank providing the unit. These SOPs are sent by the cord blood bank and are not always adapted to the disposals and reagents used by the department who then thaw the units. Diane Fournier, PhD, of Héma-Québec, and Roger Horton, PhD, of The Anthony Nolan Cord Blood Bank, will discuss manual and automatic thawing methods used by different departments for thawing of these units, and what can be done to improve recovery of the cells. Also, a multi-center study for harmonization of post thaw analysis of CD34 and CD45 cells will be presented.

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FACT Immune Effector Cellular Therapy Inspection and Accreditation Workshop at ASH Annual Meeting
Friday, December 8, 2017
Atlanta, GA

This training workshop is designed to educate participants on two key perspectives: building quality into their immune effector cell programs and performing peer-based inspections. FACT’s mission is to improve the quality of cellular therapy programs and depends on volunteer experts to visit programs and assess their compliance with the Standards. This peer-review approach keeps FACT accreditation credible, relevant, and useful. Attendees will learn about the mission of FACT, principles of FACT Standards, the accreditation process, and basic inspection techniques.

Registration is free for current inspectors and approved inspector trainees. Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements. To apply to become an inspector, submit an online application.

View meeting details and register online

WMDA-NetCord Webinar: Cord Blood Outcome Data: How to Get it and How to Use it
Wednesday, December 13, 2017
Webinar

This webinar is December 13, 2017, at 10:00 ET. It is often difficult for cord blood banks to obtain outcome data following administration. Gesine Koegler, PhD, of the José Carreras Cord Blood Bank in Düsseldorf, and Andrea Darrow, Quality Manager at Cryo-Cell International, will discuss how to get and how to use cord blood outcome data. What have banks done that work well? And, once the information is received, how can it be used?

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QM Series 8: Staff Involvement in Document Control: Where do YOU fit in?
Wednesday, January 10, 2018
Webinar

This webinar is January 10, 2018, at 11:00 am ET. Mary Ann Kelley, DFCI, Associate Director of Quality Assurance CMCF at Dana Farber Cancer Institute / Cell Manipulation Core Facility, will discuss how staff is critical in the document control process, including developing, revising, reviewing, training, and accessing records. It will include information about protocols, and how to give staff access if programs rely on protocols instead of programmatic SOPs. This is the second webinar in the QM Series, Module 8.

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Applying the FACT Cord Blood Standards in Private Banking
Wednesday, January 17, 2018
Webinar

This webinar is January 17, 2018, at 9:00 AM ET. Elisabeth Semple, PhD, Cord Blood Bank Director at Cells for Life Cord Blood Institute Inc., Arvin Faundo, MD, Cord Blood Bank Director at Cordlife Group Limited, and Alexander Platz, MD, Cord Blood Bank Director at DKMS Cord Blood Bank, will discuss how family cord blood banks can comply with the NetCord-FACT 6th Edition Cord Blood Standards, methods to overcome challenges, and the benefits to achieving FACT accreditation.

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QM Series 8: The Digital Age: Controlling Documents within an Electronic System
Wednesday, January 24, 2018
Webinar

This presentation is Wednesday, January 24, 2018, at 11:00 am ET. Rebecca Maddox, Compliance Coordinator at Mayo Clinic Florida, will discuss the following:

  • The advantages and disadvantages of using a system,
  • How to incorporate an electronic system into your program,
  • Considerations to take into account when evaluating systems,
  • How to assess a system for compliance with the FACT Standards, and
  • What works well with her electronic system and what surprises she encountered.

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WMDA-NetCord Webinar: Informed Consent
Wednesday, February 7, 2018
Webinar

This presentation is Wednesday, February 7, at 11:00 am ET, 4:00 pm GMT. Daniel Gibson, Bsc (Hons), LIBMS, and Linda Moss, RM, of Anthony Nolan Cell Therapy Centre, will thoroughly review the different methods banks use to obtain informed consent, and the pros and cons of each method.

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FACT Cellular Therapy Inspection and Accreditation Workshop
BMT Tandem Meetings
Tuesday, February 20, 2018
Salt Lake City, UT

The blood and marrow transplant field has been a leader in voluntarily improving quality, and accredited Clinical Programs are currently adapting to several new FACT Standards and procedural changes to the accreditation process. This workshop will provide background on these changes. The morning workshop sessions include major topics such as how to effectively transition to the 7th Edition Hematopoietic Cellular Therapy Standards, CIBMTR data audits, clinical outcomes including center reported causes of low survival, and the accreditation of immune effector cellular therapy programs.

The afternoon session includes two different tracks: New Inspector Training Orientation and Common Citations. The Inspector Training track includes sessions on the FACT accreditation process, what documents to review before an inspection, the ins and outs of performing an onsite inspection, how to conduct an exit interview, and finally, how to make your case via the inspection report. The Common Citations track will review recent deficiencies and corrections related to commonly cited Standards in the areas of quality management, personnel, and donor information and consent to donate. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.

Note: Inspector trainees are required to attend the New Inspector Training Orientation Track.

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Cellular Therapy Leadership Course at BMT Tandem – 101
Tuesday, February 20, 2018, 8:00 am – 12:00 pm
Salt Lake City, UT

Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome.

In years past, participation in FACT’s leadership workshop has been by invitation. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.

The highly interactive and participatory curriculum teaches leadership principles including:

  • The leader as coach
  • Differences between managing and leading
  • Basic styles of leadership and how to recognize your own style
  • When each style of leadership may be appropriate
  • Running and participating in effective meetings
  • How to build consensus
  • Four proven ways to motivate people
  • Effective delegation skills
  • How to adapt to change, and even be a change agent
  • Understanding and exercising governance roles and responsibilities

Woven throughout the leadership course is an overview of FACT’s organizational structure, purpose, challenges, current programs and accomplishments.

Whatever you lead, this 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.

View meeting details and register online

Advanced Cellular Therapy Leadership Course at BMT Tandem – 201
Tuesday, February 20, 2018, 1:15 pm – 4:30 pm
Salt Lake City, UT

If you completed FACT’s Cell Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Topics include:

  • Characteristics of a healthy organization
  • Adapting an organization to a changing environment
  • Multiplying and diminishing the effectiveness of a team
  • Leading from where you are
  • Servant leadership
  • Effective governing boards
  • Legal implications of decision-making and liability and fiduciary responsibilities
  • Strategic planning with a focus on outcomes

Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.

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Cellular Therapy Collection Workshop at ASFA Annual Meeting
Wednesday, April 25, 2018
Chicago, IL

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities. FACT representatives will be in attendance to 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.

View meeting details and register online

 

Cellular Therapy Inspection and Accreditation Workshop at ISCT Annual Meeting
Tuesday, May 1, 2018
Montreal, Quebec, Canada

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to 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 afternoon session will include two different tracks (to be arranged). All sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.

View meeting details and register online