Time

Mins

Title

Description

7:30 am CT

12:30 GMT

30'

Networking with Colleagues

Description: We invite you to join workshop hosts and your colleagues for pre-workshop networking.  Even though we can’t meet in person, that doesn’t mean business — or the need to build relationships — stops.  During this session, we will provide you with all of the meeting ins and outs and have a little fun together while preparing for a fabulous day! 

8:00 am CT

13:00 GMT

15’

Welcome

Description: Apheresis workshop hosts Dr. Leon Su and Dr. Nicole Aqui, and Processing workshop hosts Brian Jones and Sara Murray, welcome all participants to the FACT Apheresis and Processing Inspection & Accreditation workshop. Workshop hosts will share tips to help make your virtual workshop experience flawless. 

8:15 am CT

13:15 GMT

60’

Both Tracks:

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. 

9:15 am CT

14:15 GMT

30’

Processing Presentation:

The Key to Compliance Success

Description: Federico Rodriguez Quezada, SBB, MLS(ASCP), Stem Cell Lab Coordinator at UF Health Shands Hospital, will review the entire compliance application process.  He will identify documents required for submission and give appropriate examples. 

9:15 am CT

14:15 GMT

35’

Apheresis Presentation:

The Key to Compliance Success

Description: Renee Smilee, BSMT(ASCP), CQIA (ASQ), Performance Improvement Lead at H. Lee Moffitt Cancer Center, will review the entire compliance application process.  She will identify documents required for submission and give appropriate examples. 

.

9:50 am CT

14:50 GMT

15’

Both Tracks:

Break

10:05 am CT

15:05 GMT

30’

Processing Activity: 

Evaluting Compliance

Description:  Federico Rodriguez Quezada, Stem Cell Lab Coordinator at UF Health Shands Hospital, will present case studies. The audience will identify what challenges the program faces after each case. Federico will poll the audience to determine what standards may not be in compliance.  Ultimately, Federico, with the help of the audience, will answer how the program can achieve compliance with FACT Standards and continue FACT accreditation.

10:05  am CT

15:05 GMT

30’

Apheresis Activity: 

Evaluating Compliance 

Description: Renee Smilee, Performance Improvement Lead at H. Lee Moffitt Cancer Center, will present case studies. The audience will identify what challenges the program faces after each case. Renee will poll the audience to determine what standards may not be in compliance.  Ultimately, Renee, with the help of the audience, will answer how the program can achieve compliance with FACT Standards and continue FACT accreditation.

10:35 am CT

15:35 GMT

55’

Processing Presentation:

What to Expect During the Inspection: Inspection Strategies from the Applicant's Point of View

Practice a Guided Tour of a Processing Program
 

Description of session: Charlie Branson, MS, Manager of the Biologics Production Facility at Nebraska Medicine, will review program expectations during a FACT inspection.  Charlie will list tips and identify strategies to help programs navigate a successful inspection process. He will also discuss what it is really like during the onsite inspection from an applicant point of view.

10:35 pm CT

15:35 GMT

55’

Apheresis Presentation: 

What to Expect During the Inspection: Inspection Strategies from the Applicant's Point of View

Activity: Practice a Guided Tour

Description: Elizabeth Ferraro, Quality Management Coordinator at Biologics Production Facility at Nebraska Medicine, will review apheresis program requirements during a FACT inspection.  Elizabeth will list tips and identify strategies to help apheresis programs navigate a successful inspection process. She will also discuss what it is really like during the onsite inspection from an applicant point of view.
 

11:30 pm CT

16:30 GMT

30’

Processing Presentation:

Correction of Deficiencies

Description: Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic health center, will explain the most common challenges in processing, and construct a plan to correct the deficiencies. 

 

11:30 pm CT

16:30 GMT

Processing Presentation: 

Correction of Deficiencies

12:00 pm CT

17:00 GMT

30’

Processing
Activity:

Dissecting Deficiencies

Description: Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic health center, will practice evaluating deficiencies with the audience and recommend correction.

12:00 pm CT

17:00 GMT

30’

Apheresis
Activity:

Dissecting Deficiencies

Description: Joan M. Sevcik RN, BSN, Director of HPC Apheresis Clinical Operation at Vitalant, will practice evaluating deficiencies with the audience and recommend correction

12:30 pm CT

17:30 GMT

45’

Both Tracks:

Lunch

1:15 pm CT

18:15 GMT
 

15’

Jeopardy!

18:30 GTM

60’

Both Tracks:

How to prepare for a FACT Virtual Inspection

Description: Suzanne Birnley, MS, MBA, FACT Accreditation Manager, will discuss FACT's virtual inspections process in response to COVID-19.

2:30 pm CT

19:30 GMT

45’

Both Tracks:

Navigating the 8th Edition FACT-JACIE Cellular Therapy Standards

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

3:15 pm CT

20:15 GMT

15’

Both Tracks:

Break

3:30 pm CT

20:30 GMT

40'

Both Tracks:

When Things Don’t Go as Planned . . . How Chain of Identity and Chain of Custody Can Help

Description: Chain of identity (COI) and chain of custody (COC) allow cellular therapy professionals to verify that the right product is safely given to the right patient. These documents assist with the investigation, resolution, and prevention of occurrences. Using a mock inspection format, this featured session of  the FACT Accreditation and Inspection Workshop will illustrate  how  (COI) and (COC) can be used to track and trace cellular therapy products and demonstrate how (COI) and (COC) assist with occurrence management and provide evidence of compliance with FACT requirements.

4:30 pm CT

21:30 GMT

30'

Both Tracks:

Panel Discussion

5:00 pm CT

22:00 GMT

15'

Both Tracks:

Closing

Description: Workshop hosts will recap the entire day, reflect on productive conversations, and invite participants to share a take-away, action step, or highlight from the workshop.

5:00 pm CT

22:00

Both Tracks:

FACT Virtual Lounge

Description: Remember when we used to be able to meet at the end of the workshop day to network, laugh, and share stories? Well, in an effort to keep some sort of normalcy, we invite you to join us in the FACT Virtual Lounge for happy hour!  When you enter the lounge, you are able to see who's in the various lounge video rooms, join the room of your choice, and pop in and out of the lounge rooms at your leisure. Relax with your favorite drink, connect with your colleagues, talk shop, or just be social! A FACT representative will be in each room.

5:15 pm CT

22:15 GMT

30'

Optional Session:

FACT Accreditation Portal Training