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REFLECTREFLECTREIMAGINEREIMAGINERECOMMITRECOMMITFACTFACTEVENTSEVENTSTANDEMTANDEM20252025prior to at the

Accreditation WorkshopFebruary 10, 2025 | 8: 00 AM | Kauai/Maui Ballroom $595Quality Boot CampFebruary 11, 2025 | 8: 00 AM | Kauai/Maui Ballroom $675Participants will hear expert presentationsand engage in roundtable activitiesfacilitated by experienced FACT Inspectorsand quality personnel. This year's bootcamp theme is Audits. FACT instructors willdiscuss the purpose of an audit, how anaudit schedule is created, the phases of anaudit cycle, and the required audits foraccreditation. Participants will developaudit schedules and prepare for externalaudits. Participants should be prepared fora highly interactive learning experience.This interactive workshop is designed todescribe FACT's Accreditation process in anengaging format. Experienced FACTinstructors will facilitate the workshop, whichwill include roundtables, case studies, andopportunities to discuss real-life scenarioswith your colleagues. Presenters will discussaccreditation requirements and expectations,how to position your organization to pursueaccreditation, methods for maintainingaccreditation, and tips for avoiding andcorrecting common citations. Additionaldiscussion areas include audits and correctiveaction plans to improve clinical outcomes anddata management.

February 11, 2025 | 8: 00 AM | Kohala/Kona Meeting RoomVisit the Booth!FACTInspector TrainingFebruary 12-15, 2025 | 9: 00 AM | Booth 134We invite you to APPLY to become anInspector and attend the FACT InspectorTraining Course. The FACT InspectorTraining Course is only for approvedinspector trainees and active inspectors.Trainees must complete all prerequisitesbefore attending. This course providestrainees with practical, hands-on sessionsfacilitated by experienced FACT inspectors.FACT inspector trainees learn abouttechnology tools, preparation essentials,common citations, the inspectionprocesses, and what to expect after theinspection. We invite you to visit the FACT Exhibit Booth #134 at Tandem.Learn more about accreditation, becoming a FACT inspector,FACT Consulting Services, and meet key FACT staff!Look for us in the Expo Center beginningFebruary 12th. Join us for games, giveaways,and more! If you are a FACT Inspector, stopby and grab your Inspector ribbon!Keep an eye out for special guests andtimes and more FACT Booth excitement!

RoundtableRoundtable Activity9:00 - 10:00 AMRoundtableRoundtable Activity11:00 - 12:00 PM8:00 - 8:15 AMQuality Systems IntegrationsThis session focuses on the interconnectedness ofquality management processes in cellular therapyprograms and strategies for their integration. 8:15 - 9:00 AMAudit OverviewParticipants will receive a comprehensive overview ofaudits in quality management systems. Throughinteractive discussions and practical exercises, they willgain the preliminary knowledge to implement a robustaudit process in their program.10:15 - 11:00 AMUsing Audit ResultsParticipants will focus on enhancing quality managementby leveraging audit results during this presentation.Through case studies and hands-on roundtable work,attendees will be equipped with practical skills totransform audit results into meaningful qualityimprovements.Overview of Outcome AnalysisThis session focuses on the criticalrole of outcome analysis.Participants will participate in casestudies and practical exercises andconclude with strategies forimplementing effective follow-upactions for corrective measuresleveraging outcome analysis forcontinuous improvement in theirprograms. 12:45 - 1:30 PMFebruary 10, 2025Quality Boot Camp12:00 - 12:45 PM LUNCH

RoundtableRoundtable Activity1:30 - 2:30 PMRoundtableRoundtable Activity3:30 - 4:30 PMClosing / Q&A4:45 - 5:00 PMWrap Up2:30 - 2:45 PM BREAKWhat Have We Learned?The hosts will comprehensively review andsynthesize the quality management approachesexplored throughout the day. Participants will betterunderstand best practices, enabling them to selectand implement the most effective approaches fortheir specific program needs. 4:30 - 4:45 PMFebruary 10, 2025 Quality Boot CampCredits2:45 - 3:30 PMOutcome Analysis-Setting Benchmarks Participants will engage in benchmarking techniquesto enhance cell therapy program performance.Roundtable exercises will enforce tools used toimplement effective benchmarking strategies.Participants will be equipped to design action plansthat address specific, measurable goals and timelines. This activity is approved by NAHQ® for 8.0 hours of CPHQ CE credits.This activity has been planned and implemented in accordance with the accreditationrequirements and policies of the Illinois State Medical Society (ISMS) through the JointProvidership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health isaccredited by the Illinois State Medical Society to provide continuing medical educationto physicians. This live activity is designated for a maximum of 8.0 AMA PRA Category 1Credits™. Physicians should claim only the credit commensurate with the extent of theirparticipation in the activity.

8:00 - 8:45 AMFACT Accreditation PreparationThis session begins by explaining the critical componentsof the FACT accreditation process. Participants will gain acomprehensive understanding of the accreditationprocess, develop practical strategies for preparation andcompliance, and learn how to create a comprehensiveaction plan for FACT accreditation preparation. The finalpart of the session will focus on the various roles of thekey players in the accreditation process.February 11, 2025Accreditation WorkshopCompliance Application SuccessThis session begins by explaining thecritical components of the FACTaccreditation process. Participants willgain a comprehensive understandingof the accreditation process, developpractical strategies for preparation andcompliance, and learn how to create acomprehensive action plan for FACTaccreditation preparation. The finalpart of the session will focus on thevarious roles of the key players in theaccreditation process.8:45 - 9:30 AM9:30 - 10:00 AMPortal Session for Accreditation ApplicationThis session provides participants with a comprehensiveexperience in navigating the FACT Accreditation Portaland completing the compliance application for cellulartherapy program accreditation. Attendees will gainpractical skills to demonstrate compliance with FACTStandards through effective documentation submission.Indicates an interactive activity with the session.

10:00 - 10:30 AMLeveraging FACT Accreditation Presenters will provide participants with a comprehensiveoverview of FACT, its role in the cellular therapy field, andits latest initiatives. In this session, participants willexplore the relationship between FACT accreditationrequirements and other regulatory standards and focuson FACT’s efforts to streamline the assessment process,reducing programaudit burdens.BREAK10:30 - 10:45 AMIncorporating a Quality Management Plan in theAccreditation ProcessParticipants will gain a comprehensive understanding ofQuality Management Plans (QMPs) in the context ofFACT Standards. The session will begin by explaining theessential elements of a QMP as outlined in FACTStandards. Throughout the session, participants willengage with real-world examples and case studiesdemonstrating the successful implementation of QMPsin cellular therapy programs and learn about commonchallenges and strategies to overcome those challenges.11:45 - 12:15 PMA Closer Look at FACT StandardsThis session begins by differentiatingbetween the critical components of FACTStandards and how these standardscollectively address quality managementacross the entire cellular therapy process.Participants will focus on practicalexamples of how programs havesuccessfully adapted their operations tomeet FACT accreditation requirements. 10:45 - 11:45 AMFebruary 11, 2025Accreditation Workshop

Preparing for an Effective FACT Inspection The session begins by outlining the expectations of aFACT inspection, including the critical componentsassessed and the roles of various participants during theon-site visit. Attendees will learn what inspectors look forduring inspections and how to engage with themeffectively. The session concludes with real-worldexamples of a comprehensive preparation strategy for aFACT inspection.12:45 - 1:15 PMFebruary 11, 2025Accreditation WorkshopLUNCH12:15 - 12:45 PMCorrection of DeficienciesThis session focuses on common challenges in compliancewith FACT standards. It begins by exploring the mostfrequent clinical deficiencies observed by FACT inspectors.Participants analyze patterns from previous FACTinspection reports, revealing programs' challenges. Thesession concludes by presenting evidence-basedstrategies to address these challenges. 1:30 - 2:30 PMWhat Happens After the InspectionPresenters will provide participants withan overview of the post-inspectionaccreditation process, availableresources, and timeline planning.Participants will learn about the roles andresponsibilities of key stakeholders, beintroduced to the various tools andresources available, and conclude with theconstruction of critical milestones tosuccessfully navigate the post-inspectionprocess. 1:15 - 1:30 PMBREAK2:30 - 2:45 PM

Accreditation Success Stories (LIVE)Real-world program participants focus on successfulapproaches to overcoming challenges in meeting andmaintaining FACT Standards compliance. The session willbegin by presenting success stories from differentcellular therapy programs that have achieved FACTaccreditation and comparing strategies that led tosuccessful compliance and accreditation. 2:45 - 3:15 PMCorrective Action Plans and Audits for Outcomesand Data ManagementParticipants will learn the components of effective auditsand corrective action plans for successful accreditationand improved outcomes. The session will begin byexplaining the rationale for conducting periodic internaland external audits of data and outcomes. Throughout thesession, real-world examples and case studies willillustrate the application of these concepts and equipparticipants with practical skills to perform effectiveaudits and develop effective CAPs, ensuring ongoingcompliance with FACT standards.3:15 - 3:45 PMFebruary 11, 2025Accreditation WorkshopStrategies for Maintaining FACT ReadinessThe session begins by exploring effective methods toprepare and support participants in maintaining FACTaccreditation. Participants will learn to design targetedtraining programs, establish clear communication channelsfor standards updates, and create systems for ongoingcompetency assessment and professional development.The session concludes with real-world examples and casestudies demonstrating the successful implementation ofthese strategies for continuous FACT accreditationreadiness.3:45 - 4:30 PM

Ask FACT Anything - Panel Discussion This panel discussion brings together experts fromdiverse programs to answer questions and sharestrategies for achieving and maintaining FACTaccreditation. The session features dynamic exchanges ofideas as panelists discuss their unique approaches toFACT compliance. Participants will have an opportunity toask questions in an open forum format. 4:30 - 4:55 PMClosing / Q & A4:55 - 5:00 PMCreditsFebruary 11, 2025Accreditation WorkshopThis activity has been planned and implemented in accordance with the accreditationrequirements and policies of the Illinois State Medical Society (ISMS) through the JointProvidership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accreditedby the Illinois State Medical Society to provide continuing medical education to physicians.This live activity is designated for a maximum of 8.0 AMA PRA Category 1 Credits™.Physicians should claim only the credit commensurate with the extent of their participationin the activity.

February 11, 2025 Inspector TrainingPreparation EssentialsInspector Trainees can expect a comprehensive andfocused session to enhance their understanding ofFACT inspections and improve their preparationstrategies. The session will begin with an in-depthanalysis of the Eighth Edition Inspector Test andKnowledge Check quiz results, providing a foundationfor subsequent discussion and strategy development. 8:00 - 9:00 AMPortal Session 1 - Reviewing the Compliance ApplicationThis session will focus on mastering the FACTAccreditation Portal and developing critical evaluationskills for reviewing compliance applications. InspectorTrainees can expect a comprehensive and hands-onexperience covering the locations of essential featuresand resources, tool reviews, and documentationmanagement within the system.9:00 - 9:30 AM9:30 - 9:45 AM BREAKInspection Process -Part 1Inspector Trainees will gain insights into the FACTinspection process, focusing on critical steps, inspectortools, and evaluation techniques. The session will alsofocus on developing essential evaluation skills for pre-inspection documents and comparing providedinformation against FACT requirements. Throughoutthe session, Inspector Trainees will engage in hands-onactivities with experienced FACT inspectors.9:45 - 10:15 AM10:15 - 11:45 AMHands-On Work withFacilitatorsInspector Trainees havean opportunity to practicewhat they have learnedand demonstrateproficiency.

Common Citations/Writing CitationsThis session begins by examining the most prevalentdeficiencies encountered in cellular therapy programs.Inspector Trainees will focus on understanding,identifying, and effectively communicating deficienciesin compliance with FACT Standards. Participants canexpect a comprehensive exploration of crafting clearand concise citations for common deficiencies,adhering to FACT citation guidelines, and developinganalytical skills to evaluate citation quality through caseexamples.12:15 - 1:00 PMInspection Process - Part 2Inspector Trainees will further their comprehensiveunderstanding of the FACT inspection processes byfocusing on evidence gathering, complianceassessment, and evaluating the physical locationthrough the on-site tour. The session will begin byexploring various inspection scenarios and strategiesfor gathering evidence of compliance ornoncompliance, demonstrating the proper use ofcompliance checklists, and evaluating the physicallocation through an effective on-site tour.1:00 - 1:30 PM11:45 - 12:15 PM LUNCHBREAK2:15 - 2:30 PM1:30 - 2:15 PMHands-On Work with FacilitatorsInspector Trainees have an opportunity to practicewhat they have learned and demonstrate proficiency.February 11, 2025 Inspector Training

Inspection Process - Part 3This session focuses on critically examining the on-sitedocuments to identify critical areas of compliance andpotential deficiencies. Inspector Trainees will practicedetermining which areas require further investigationduring the on-site inspection. By the end of the session,Inspector Trainees will have a thorough understandingof the FACT inspection processes and be equipped withthe necessary skills to conduct effective inspections. 2:30 - 2:45 PMPortal Session 2 – Entering Citations & Completing the ReportThe final portal session highlights the FACTAccreditation Portal’s essential features and functions.Inspector Trainees will gain insights into the portal'srole in streamlining the accreditation process andensuring inspection consistency. Inspector TraineesAttendees will learn the proper techniques for enteringcitations and marking checklist items within the portal.The session also includes practical exercises forentering citations and completing inspection reports.3:30 - 4:00 PM2:45 - 3:30 PMHands-On Work with FacilitatorsInspector Trainees have an opportunity to practicewhat they have learned and demonstrate proficiency.February 11, 2025 Inspector Training

CLOSING / Q & A4:45 - 5:00 PMFebruary 11, 2025 Inspector TrainingAccreditation Doesn’t End with the InspectionInspector Trainees will explore the crucialelements of a successful exit interview following aFACT inspection and engage in analyzing well-structured inspection reports and reviewcitations. The final part of the session will focus onevaluating the overall inspection process, learningbest practices for post-inspection activitiesenabling them to contribute more effectively tothe inspection process.4:00 - 4:30 PMAsk FACT Anything - Facilitator PanelThe final session will feature an engaging paneldiscussion, providing Inspector Trainees with aunique opportunity to interact directly with FACTinspectors in an open Q&A format.4:00 - 4:30 PMCreditsThis activity has been planned and implemented in accordance with the accreditationrequirements and policies of the Illinois State Medical Society (ISMS) through the JointProvidership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accreditedby the Illinois State Medical Society to provide continuing medical education to physicians.This live activity is designated for a maximum of 8.0 AMA PRA Category 1 Credits™.Physicians should claim only the credit commensurate with the extent of their participationin the activity.

Important ConsiderationsAll participants must be registered and paid no later than Friday, January 24, 2025. Wecannot accept on-site registrations.Participants may pick up badges and materials from 4 -5 pm the night preceding theconference as follows:Quality Boot Camp - Badges Only Pick-up 4:00 - 5:00 PM on Sunday, 2/9 at Kauai/Maui Ballroom FoyerAccreditation Workshop - Badge/Material Pick-up 4:00 - 5:00 PM on Monday, 2/10 at Kauai/Maui Ballroom FoyerAll participants must be registered and paid no later than Friday, January 24, 2025. Wecannot accept on-site registrations.Quality Boot Camp participants will have assigned seating to facilitate roundtablediscussion and facilitator involvement. While you may not be seated with your colleagues,you will have an opportunity to network during lunch and breaks.Participants will receive a confirmation notice within 24 hours of registration for any FACTevent. If you do not receive a confirmation notice, please check your spam or organization’semail firewall site. Contact us at factevents@factglobal.org so we can troubleshoot. Addfactevents@factglobal.org to your safe sender's list or ask your organization to add it to thewhitelist.For participants who would like a certificate for their CME/CE credits, be prepared toprovide your credentials and/or your NPI # so that we can report your credit to theappropriate crediting bodies.The event price does not include your hotel stay. For housing options, please visit theTandem registration site.Participants will be asked to complete an online evaluation of the event. For those thatwish to receive credit, the evaluation is required prior to receipt of their credit certificate.For the most up to date information visit our website at https://learn.factglobal.org/FACTatTandem2025