Alisha Loy; BS, CRCST: Quality & Lean Management Engineer
Sheila Ouverson; BS, MPA: Stem Cell Transplant & Cellular Therapy
Program Administrator
A Quality & Lean Foundation in Program Design:Cancer’s “Newest Miracle Cure”
What is CAR T Cell Therapy?Chimeric antigen receptor
Program Design: What Does That Look Like?
Waste identification: Use of “The Wall” & collaborative process discussions
Detailed Tasks
Executive Oversight CommitteeSheila Ouverson (BMT Administrator) Sabi Singh (UIHC Chief Operating Executive) JoEllen Browning (Operating Budget Director) Annette Schlueter (Blood Center Director) Ami Gaarde (Nursing Director) Yogesh Jethava (Oncology Physician)Umar Farooq (Oncology Physician) Cindy Dawson (UIHC Chief Nursing Executive) Kevin Doerschug (MICU Physician)Margarida Silverman (BMT Medical Director) Mike Brownlee (UIHC Chief Pharmacy Executive) Arunkumar Modi (Pediatric Oncology Physician)George Weiner (HCCC Division Director) Rose Meyer (Pathology Administrator) Yatin Vyas (Pediatric Physician)Tina Devery (HCCC Division Director) Mari Ehler (Revenue Cycle Assoc. Director) Gregory Schmidt (Internal Medicine Physician)Mark Granner (Neurology Physician) Joanne Becker (JOC Assoc. Director) Carlie Etscheidt (HCCC Research Administrator)Diane Cerven-Jenn (Pharmacy Finance Manager) Deanna Brennan(COC Director) Lindsay Dozeman (BMT Quality Engineer)Lisa Manesis (HCIS Assoc. Director) David Weetamn (Pharmacy Director) Amy O’Deen (SFCH Chief Operating Executive)Rebecca O’Rourke (UIHC Director) Katie Gaspar (Pharmacy Clinical Specialist) Kim Wilkerson (HCIS Manager)Amanda Reimann (Marketing Manager) Megan Threlkeld (Revenue Cycle Director) Amanda Oakland (Revenue Cycle Manager)Ann Showers (Finance & Accounting Officer) Trisha Smith (Pharmacy Director) Erica Gentry (Revenue Cycle Manager)Shannon Hunger (BMT Nurse Manager) Alisha Loy (OE Quality & Lean Engineer) Porsche Mulherin (PFS Coding)
Core TeamSheila Ouverson (BMT Administrator) Margarida Silverman (BMT Medical Director) Paula Mccue (HCCC Nurse Clinician)Lauren Ringe (Internal Med. Supervisor) Yogesh Jethava (Oncology Physician) Beth Alden (Pathology Lab Sup.)Jessie Alex (Internal Med. Nurse Practitioner) Porsche Mulherin (PFS Coding) Rose Meyer (Pathology Administrator)Keri Semrau (Ambulatory Care Director) Arunkumar Modi (Pediatric Oncology Physician) Teri Castor (Revenue Cycle Manager)Julie Landsteiner (Pediatric Oncology Nurse Manager) Annette Schlueter (Blood Center Director) Trisha Smith (Pharmacy Director)Cheryl Bombei (UIHC Staff Nurse) Julie Aschenbrenner (BMT Nurse Coordinator) Erica Gentry (Revenue Cycle Manager)Julie Wiebold (Rehabilitation Therapy Nursing Leader) Beth Kaufman (BMT Nurse Coordinator) Rhonda Evans (BMT Nurse Coordinator)Kristina Ehret (UIHC Assistant Nurse Manager) Annette Norland (BMT Nurse Coordinator) Denise Litwiller (HCIS Nurse Practice Leader)Tina Devery (HCCC Division Director) Stephanie Palmer (BMT Nurse Coordinator) Sherry Lang (HCIS Nurse Practice Leader)Umar Farooq (Oncology Physician) Shannon Hunger (BMT Nurse Manager) Darin Johnson (Pharmacy Beacon Team)Denise Baird (Pathology Qual. & Compliance Coord.) Ann Showers (Finance & Accounting Officer) David Weetman (Pharmacy Director)Karmen Dillion (HCIS Director) Megan Threlkeld (Revenue Cycle Director) Katie Gaspar (Pharmacy Clinical Specialist)Carlie Etscheidt (HCCC Research Administrator) Lindsay Dozeman (BMT Quality Engineer) Meredith Ginn (Pharmacy Pharmacist)Jim McCollough (BMT Nurse Coordinator) Barb Schuessler (Emergency Med. Admin.) Alisha Loy (OE Quality & Lean Engineer)Jodi Felderman (Finance & Accounting Director) Keri Fitch (Revenue Cycle Benefits Rep.) Kelli Trimpe (Revenue Cycle Coord.)
Key ResourcesBarb Schuessler (Emergency Med. Administrator)Kevin Doerschug (MICU Physician)Mark Granner (Neurology Physician)Amanda Reimann(Marketing Manager)Karen Parrott (Research Clinical Trial Specialist)Julie Kurt (Prior Authorization Supervisor)Ellen Chambers LawGeralyn Quinn (HCCC Clinic Nurse Manager)
Key StakeholdersPatty Hession (Internal Medicine Assistant Director)Mike Hartley (UIHC Emergency Manager)Degowin Blood CenterHolden Comprehensive Cancer CenterUIHC Research & Institutional Review BoardUIHC Physician’s GroupSabi Singh (UIHC Chief Operating Executive)
Vendor TeamDawn (Onsite Support/ Novartis Vendor)Pat (Onsite Support/ Kite Vendor)Jeff (Clinical Trial Support/ Kite Vendor
(Zuma-7))
Project Team Structure
Logic Model
Inputs FACT accreditation/ standards. Vendor Instructions for Use/ Standard Operating Procedures (SOP). Patient Volumes/ Demand—Current state & future increase. Collection of Cells/ CAR T Product. FDA approval for use (by cancer type). Resource identification & allocation(treatment teams, space,
equipment, materials, drugs)
Assumptions/ Key Partnerships Holden Comprehensive Cancer Center (HCCC) will provide CAR T Cell
Therapy for all available FDA approved therapies. UIHC will partner with Novartis & Kite in service provision for the
production of CAR T Cell Therapy. UIHC will maintain required accreditations & complete requirements
for service provision for CAR T Cell Therapy as outlined by the industry.
UIHC HCCC will partner with specialties needed in the creation of core CAR T Cell Therapy treatment teams.
Planning Activities Data analysis will be completed to create patient volume
predictions for each cancer type. Resource needs and allocations will be determined
considering short, mid and long range planning. Creation of Workflows in EPIC—IT resource allocation. Evaluation for service provision demands of current state
space and potential future state space will be completed. Evaluation of partner organization materials for process
completion will occur in effort to determine creation of one standard operating procedure.
Coordination of required trainings for all treatment team members with identified SME for CAR T in each area.
Gap Analysis & Risk Assessments completed for each treatment team area. Creation of containment strategies for each area completed.
Communication, Implementation & Follow Up Cycle
Desired Results (Outputs, Outcomes, & Impact)
Increase in durable responses and potentially in overall survival for patients receiving CAR T Cell Therapy.
Increase in referral base & partnership requests from external sources.
Satisfied patients, willing to referral others for services.
Involvement in providing generalized therapies as they are FDA approved.
CAR T Cell Therapy offered in Iowa and surrounding Midwest areas.
Increase in patient volumes, visits, and revenue for other HCCC services.
Recognized as an industry leader in CAR T Cell Therapy.
Creation of core CAR T Cell Therapy treatment teams.
New revenue stream for UIHC with increased future potential.
Obtain & Maintain Certification for CAR T Cell Therapy.
Implementation Activities Hire identified resources prior to training & service
demands. Creation & Implementation for administrative standard
operating procedure. UIHC representation on standards & quality committees
for CAR T Cell Therapy. Create & Implementation for administrative standard
related to clinical trials. Market ready for Pharma service promotion. Creation of EPIC workflows, TCT workflows, etc…
Influential Factors
FDA approval of CAR T Cell Therapy for two cancer types.
Predications of further use of CAR T Cell Therapy for multiple other cancer types.
UIHC available specialties and partnership capabilities under same roof.
Acuity & Mortality & Morbidity of patients and CAR T Cell Therapy service provision risks.
External Partnership (Vendors, Referring Physicians, & Community Supports).
Future of Cancer Medicine (Marketing, “sexiness factor”, staying competitive).
New Industry Service—Oversight structures, Quality & Outcomes demands.
Future ROI; increase clinical trials, referrals, physician recruitment, therapy generalizability.
Patient population (Rural State, % of out of state pts., age, etc..).
Proximity to other CAR T Cell Therapy providers.
Science & generalizability of CAR T Cell Therapy.
Evaluation & Reporting (Measurement of Outcomes/
Client Impact)
Key Performance Indicators/ Dashboard Metrics:
Trend survival rates & comparison to industry benchmarks.
External referral sources, community provider partnerships.
Press Ganey scores patient likeliness to recommend services.
FDA approved CAR T therapies vs. UIHC provided CAR T therapies & Future Predictions.
Patient demographics by state & county.
Increase in patient volumes, visits, and revenue for other HCCC & Institutional services.
Standards organization involvement, presentation requests, site visits, publications and benchmark results.
Open lines & Turnover in identified required treatment team roles:
o HPC o Nursing:
Inpatient/ ICU o Support Services
ICU, Neurology, Pharmacy, ER, Infectious Disease, Hospitalist, Cardiology
o Physicians o Data Management o Quality Engineer o Nurse Coordinator(s) o Inpatient Service Staffing
(APPS) o Administrative
Billing, Insurance, Accounts Payable ROI:
o Benefits/ costs ratio o ROI (%) o Payback period
Certification o REMS Training o Chain of Custody Training o Standardized Process
(Maps) o Chain of Identity o Vendor Agreements
Nimble Decision Making & Follow Up Structure Creation of an Executive Committee for decision making
& vision casting will be created. Executive Committee will remove barriers for planning,
implementation & service provision.
Feedback Loop
Project Timeline
2016 2018Feb May Aug Nov Feb May Aug Nov Feb May
UIHC Clinical Trial Patient Received Car T Cell Infusion2/19/2016
FDA Approval for CART T Cell Therapy (Kymriah) & FDA Approval for Actemra for CRS Treatment 8/30/2017
FDA Approval for CAR T Cell Therapy (Yescarta) 10/18/2017
UIHC CAR T Cell Therapy Executive Committee Meets
2/15/2018Ped & Adult Novartis/ Kymriah REMS Training3/22/2018
Ped & Adult Novartis/ Kymriah REMS Training4/4/2018Kite Pharma Yescarta REMS Training 4/12/2018
Marketing Communications Finalized 5/1/2018
Certification Process Completed 5/22/2018
Patient Ready6/1/2018
2/19/2018 - 2/23/2018UIHC Team Attend Conference for CAR T Cell Therapy COMPLETE
2/15/2018 - 2/20/2018UIHC Logic Model Draft Creation COMPLETE
2/15/2018 - 2/27/2018Data Source Identification COMPLETE
2/27/2018 - 3/2/2018Data Analysis for Predictive Volumes COMPLETE
2/5/2018 - 3/9/2018Evaluation & Determination of Staffing Resource Needs COMPLETE
2/15/2018 - 3/31/2018Swim Lane/ Process Map Creation 17 of 17 COMPLETE
2/15/2018 - 3/31/2018SOP Revision & Creation COMPLETE
2/15/2018 - 5/1/2018CAR T Cell Therapy Marketing Materials Creation COMPLETE
2/25/2018 - 4/30/2018CAR T Cell Therapy Order Sets & Visit Type Creation COMPLETE
2/25/2018 - 5/11/2018CAR T Cell Therapy Payment Structure Creation & Payor Negotiations ON GOING
1/1/2018 - 5/22/2018UIHC Certification Process COMPLETE
Action Registers
Value of Action Registers?
Action Registers for CAR T– MAP Agreement (Contract)
– Outcomes Agreement (Contract)
– Finance– IT Workflow– Resources– Follow Up & Risk Assessment
Predictive Analysis
Predictive Patient Volumes
Baseline data from last six years used to generate predictions
25 Total Predicted Patients
0 5 10 15 20 25
Adult
Pediatric
Adult
Pediatric
Authorized Treatment Centers
Complete Process/ Flow Discussions with creation of Maps
Complete primary & sub process maps for the full process cycle (sample of 1 out of 19 maps)
Consider Flow of Patient, Family, Care Team, Information & Money
Dashboard: Design Process/ Satisfaction/ Outcomes Measures
Dashboard: Process/ Satisfaction/ Outcomes Measures
Identify Risks & Plan: Clinical & Institutional
Brain storm possible barriers using mind maps and translate into action registers.
Identify Risks & Plan: Clinical & Institutional
Sample Hazard Vulnerability Assessment (HVA) for Risk Assessment (sample of 1 out of 12)
Create Standard Work by leveraging Technology & Standard Operation Procedures
Nursing Flowsheets
Procedure Flowsheets
MAR Documentation
Screen Sets/ ModulesRemove waste for
existing systems—don’t carry over bad processes
Communication & Implementation
Create Implementation Plan– Supports– Escalations– Containment– Follow Up
Create Communication Plans (Internal/ External)
– Marketing– Stakeholder– Process Team– Executive Team
Dashboard: Process/ Satisfaction/ Outcomes Measures
What is value add for:– Visualizing Areas of Risk– Decision Making– Marketing/ Media Hype– Future Consideration– Process Implementation– Continuous Improvement– Viability
What Can You Think Of?
Questions
First CAR T Patient
