2021 FACT Inspection and Accreditation Virtual Workshop


FACT Inspection & Accreditation Workshop

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4 Feb 2021
7:30 am - 4:30 pm CT
13:30 - 20:30 GMT

Workshop Objectives: 
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.











Post-workshop Presentation








7:30 am CT



Coffee with Colleagues

We invite you to join your colleagues for coffee! Let’s face it, social distancing has us feeling disconnected and a bit exhausted. It is important to maintain relationships with co-workers and colleagues. Coming together in the morning for a virtual coffee break is a great way to brighten our day and start the workshop. So, grab your favorite mug and connect with your colleagues!

8:00 am CT




Dr. Dennis Gastineau and Dr. Jean Sanders welcome all participants to the FACT inspection and accreditation workshop. Drs. Gastineau and Dr. Sanders will introduce the workshop objectives and share tips to help make your virtual workshop experience flawless. They will also discuss the following:

  1. What FACT's key challenges have been during COVID
  2. How FACT has pivoted
  3. Where FACT is headed now, moving forward

8:15 am CT



Presentation: The Overview of FACT Accreditation

Description: This session features FACT Chief Medical Officer, Dr. Phyllis I. Warkentin. Dr. Warkentin will describe the accreditation process from application to accreditation.  Key areas will be addressed including the function of the accreditation coordinator, preparation for inspection, and the inspector role in the process of accreditation. 

9:00 am CT



Presentation: The Key to Compliance Success

Description: Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program, will review the entire compliance application process.  She will identify documents required for submission and give appropriate examples. 

9:30 am CT



Activity: Evaluating Compliance

Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program, will present three case studies. The audience will identify what challenges the program faces after each case. Dr. Bachier will poll the audience to determine what standards may not be in compliance. Ultimately, Dr. Bachier, with the help of the audience, will answer how the program can achieve compliance with FACT Standards and continue FACT accreditation.

10:00 am CT





10:15 am CT



Presentation: What to Expect During the Inspection

Activity: Practice a Guided Tour of Clinical Program

Description: Dr. Kimberly Kasow, Director, Pediatric Bone Marrow Transplant Program, Marrow Collections Medical Director at UNC Bone Marrow Transplant and Cellular Therapy Program, will review clinical program requirements during a FACT inspection.  She will also list tips and identify strategies to help clinical programs navigate a successful inspection process.

Dr. Kasow will also walk participants through guided tour of a clinical program unit.

11:00 am CT



Presentation: Correction of Deficiencies

Description: Dr. Joseph Schwartz, Director of Transfusion Medicine and Cellular Therapy at New York Presbyterian Hospital/Columbia University Medical Center - Blood and Marrow Transplant Program, will explain the most common challenges in clinical transplant and construct a plan to correct the deficiencies.

11:30 am CT



Activity: Dissecting Deficiencies

Description of session: Dr. Joseph Schwartz, Director of Transfusion Medicine and Cellular Therapy at New York Presbyterian Hospital/Columbia University Medical Center - Blood and Marrow Transplant Program, will practice evaluating deficiencies with the audience and recommend correction.

12:00 pm CT



Presentation: Maintaining FACT Readiness

Description: Dr. Leon Su of The Blood and Marrow Transplant Program at Mayo Clinic Arizona and Phoenix Children's Hospital, will discuss a plan to ensure continuous accreditation readiness. Dr. Su will explain the self-assessment process and how to manage turnover so accreditation readiness is maintained.

12:30 pm CT




Be sure to check out the featured sessions which include an interview with the Hospital Israelita Albert Einstein. The program discusses how FACT accreditation has benefited their program during the COVID-19 pandemic. Also, incoming FACT President, Cath Bollard, will share her vision for FACT as we move forward. 

1:00 pm CT 13:00 GMT 15'   JEOPARDY!  Watch Dr. Patrick Hanley, Director of GMP for Immunotherapy at Children's National Health System Blood and Marrow Transplant Program; Dr. Joseph Lynch, from the Center for Bone Marrow Transplantation at Geisinger Medical Center; and Michele Sugrue, MS, MT(ASCP)SBB, Coordinator, Research Programs at UF Health Shands Hospital, play a competitive game of JEOPARDY! 

1:15 pm CT

19:15 GMT



Presentation: How to prepare for a FACT Virtual Inspection

Description: Suzanne Birnley, MS, MBA, of the Foundation for the Accreditation of Cellular Therapy, will discuss FACT's virtual inspections process in response to COVID-19.

Dr. Phyllis Warkentin and Suzanne will answer questions after the presentation. 

2:15 pm CT

20:15 GMT



Presentation: Sneak Peek of the 8th Edition FACT-JACIE CT Standards

Description: Dr. Paul Eldridge, Research Professor at Levine Cancer Institute Transplant and Cellular Therapy Program, will discuss significant changes to the Eighth Edition FACT-JACIE Cellular Therapy Standards.

2:45 pm CT







3:00 pm CT

21:00 GMT



Data Management

Dr. Phyllis I. Warkentin, FACT Chief Medical Officer, will summarize the expectations of inspectors and applicants for data management.

3:45 pm CT


21:45 GTM



Outcome Analysis in Transplantation and Cellular Therapy

Dr. Dennis Gastineau, Medical Director, Human Cellular Therapy Lab at Mayo Clinic Arizona, will list FACT requirements for corrective actions plans to improve clinical outcomes.

4:30 pm CT

22:30 GMT




Drs. Gastineau and Sanders will recap the entire day, reflect on productive conversations, and invite participants to share a take-away, action step, or highlight from the workshop.

4:45 pm CT

22:45 GMT



Optional Session: FACT Accreditation Portal Training

Join FACT’s IT Business Analyst to learn more about the FACT Accreditation Portal.  This casual session will include information about upcoming changes to the portal, discussion about portal best practices, live instruction on issues pertaining to attendees, and an opportunity to provide portal feedback.  FACT is constantly seeking to improve the portal and develop new features to benefit the users.  What features would you like to see?