Ottr7 FACT Updates

1. Ottr7 FACT Updates Carrie Barnhart, RN, BSN, CHTC, BMTCN

2. Objectives • At the completion of this session you will: • Learn how FACT reports in OTTR7 can be used as quality tools to help support a clinical program’s quality assurance program with graphing features, the ability to stratify patients by audit types, by transplant type, or cellular therapy type and drill down directly into the patient’s record • Understand OTTR7’s audit workflow functionality as a quality tool to assist in the monitoring of critical data events within a program’s quality management plan • Become acquainted with updated terminology within HCT and our new Cellular Therapy Immune Effector Program

3. Audits - Concept Audits can assist a clinical program in the inspection, review, and documentation of quality management activities. Audits within OTTR7 are designed to verify, examine and evaluate the data within patients’ records. To drill down into the patient’s record

4. Audits: documentation • When using audit lists within OTTR7, users can: • Add an Audit Action – “flag” patients for audit • Add a text document – specific to the audit type • Populate the Audit list with results • Attach a completed program specific audit tool • Attach a copy of a lab report from the EMR

5. Audits: documentation • Data quality is important. Enter data once and use it often. • Clinical Programs will define the data fields to audit for the Pre-TED form audit. • Validate the Form’s data using the EMR (source of truth) • If necessary, correct the data field in OTTR7 and “Repopulate” the CIBMTR Form

6. FACT Reports – Basics and concept

7. FACT: Reports • The FACT Annual Audit History Report is a quality tool similar to an audit dashboard that tracks a clinical program’s audit numbers conducted within a defined year. • The results of all audits are displayed on this Audit Overview Report. Clinical programs may use this report as a tool to recognize problems, detect trends, and identify improvement opportunities in a timely manner.

8. Ottr7 FACT Updates Carrie Barnhart, RN, BSN, CHTC, BMTCN

9. Coming soon: updated or new terminology/nomenclature • “Transplant” “HCT” • Confirmatory Typing Verification Typing • Unrelated Donor (PBSC/Marrow) Workup Unrelated Donor HCT (HPC, Apheresis/Marrow) Workup • Stem Cell Product Window Product Window • Current “Stem” Cell Sources in OTTR Cell Sources • Peripheral Blood Stem Cells (PBSC) HPC, Apheresis • Bone Marrow HPC, Marrow • Donor Cellular Infusion (DCI) Donor Lymphocyte Infusion (DLI) • DCI – Peripheral Blood Stem Cells DLI, HPC, Apheresis

10. Coming soon: new cellular therapy program FACT Common Standards For Cellular Therapies (1st Ed) • Cellular Therapy: The administration of products with the intent of providing effector cells in the treatment of disease or support of other therapy. • Cellular Therapy Product (CTP): Somatic cell-based product (e.g., mobilized HPC, mononuclear cells, cord blood cells, mesenchymal stromal cells) that is procured from a donor and intended for processing and administration.

11. Coming soon: new cellular therapy program • Drop down menus for Cell Types and Tissue Types • Actions • Reports, lists, audits, calendars, documentation • Processing selections/shipping of product • Product Disposition window • Encounters (Cellular Therapy Admission) • CTP Infusion – including a Cytokine Release Syndrome tab • Clinical Trials section • Long term follow-up post CTP • Data fields to populate the CTED forms (4000, 4006 and 4100)

12. FACT: Document Submission Requirements

13. Ottr7 fact updates Questions?