Break
FACT Inspection & Accreditation Workshop
6 May 2021
7:30 am - 5:15 pm CT
12:30 - 22:15 GMT
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: |
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: |
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: |
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 |
30' |
Processing Presentation: |
Description: Joan M. Sevcik RN, BSN, Director of HPC Apheresis Clinical Operation at Vitalant, will explain the most common challenges in apheresis and construct a plan to correct the deficiencies. | ||
12:00 pm CT 17:00 GMT |
30’ |
|
Processing
|
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 |
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! |
|
|
1:30 pm CT
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 |
Description: Join panel facilitator Joseph Schwartz, MD, MPH, Division Director of Transfusion Medicine and Cellular Therapy at New York Presbyterian Hospital/Weill Cornell Medical Center, and workshop panelists and get all of your burning questions answered! | ||
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 |
'60 |
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 |
Description: 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? |