1. Session I: Web Based Reporting: What You Can Get From the Database Data Quality Report Quality Assurance Report I. Accessing Your Data Examining/Validating your data  Compliance Rates Electronic copies of your data II. Patient Management Tools Clinical timeline  Clinical measures across time  III. Patient Selection and Outcomes Quality Assurance Report Cohort (subset) report Benchmarking IV. Quality Initiatives Joint Commission Internal Initiatives V. Using Intermacs for Your Research Within your site  Across Intermacs Data Quality & Quality Assurance Reports Kathryn Hollifield, BSN RN Director of Clinical Affairs

2. Relevant Financial Relationship Disclosure Statement Data Quality and Quality Assurance Kathryn Hollifield, BSN RN Director of Clinical Affairs I will not discuss off label use and/or investigational use of the following devices: The following relevant financial relationships exist related to my role in this session:

3. Data Quality Report Session I: Web Based Reporting: What You Can Get From the Database

4. The Purpose of the Data Quality Report is to provide each hospital an up to date snapshot of key data they have entered into Intermacs and to provide lists of inconsistencies and improbable values that occur in the data. The data in this report are based on implants entered into the Intermacs web- based data application The Data Quality Report contains information from ALL INTERMACS patients at your institution. This includes patients receiving primary, subsequent, retrospective devices, and pediatric patients that were entered prior to the launch of Pedimacs. For patients who have transferred away from your institution, only information prior to the transfer is listed. Information from patients that have transferred to your institution are included in this report. Session I: Web Based Reporting: What You Can Get From the Database

5. Who receives the Data Quality Report? Site Administrators When do I receive the Data Quality report? Quarterly: Session I: Web Based Reporting: What You Can Get From the Database Calendar QuarterReport Coverage Stop Date Report Distribution Deadline Q1March 31stJune 30th Q2June 30thSeptember 30th Q3September 30thDecember 31st Q4December 31stMarch 31st

7. The DQ Report is available for you to download to your secure server or desktop. Please note this report contains PHI and should be handled following all HIPAA guidelines.

8. Where do I go to get this report? Session I: Web Based Reporting: What You Can Get From the Database Step 1:

9. Where do I go to get this report? Session I: Web Based Reporting: What You Can Get From the Database Step 2:

10. 10 Information Security Agreement when Downloading Intermacs data

11. Session I: Web Based Reporting: What You Can Get From the Database

12. Exhibit 1a. Implants by Year and Device Type The following table summarizes the number of all device types implanted at your site by year. This includes all primary, subsequent, retrospective devices, and pediatric patients that were entered prior to the launch of pediMACS. Exhibit 1b. Total Patients Receiving Implants and Implant Operations The following table lists the total number of patients enrolled at your site and the total number of implant operations. Information from patients that have transferred to your institution is not listed in this table. II. Data Quality Tables Session I: Web Based Reporting: What You Can Get From the Database

13. Exhibit 2b. Patients Missing or Incomplete Implant Form The following table contains a list of patients who have been entered into the Registry, but the implant form has not been completed. Please complete the implant form and any adverse events and follow-up forms as indicated Session I: Web Based Reporting: What You Can Get From the Database

14. Exhibit 5. Adverse Event Check The following table lists patients at your hospital that have been entered into INTERMACS and followed for more than a year with NO reported adverse events as of the end of this reporting period. Please review for accuracy. Session I: Web Based Reporting: What You Can Get From the Database

15. Quality Assurance Report Session I: Web Based Reporting: What You Can Get From the Database

16. The Purpose of the Quality Assurance Report is to facilitate the refinement of patient selection to maximize outcomes with current and new device options. Identify predictors of good outcomes as well as risk factors for adverse events after device implantation. Develop consensus best practice guidelines to improve clinical management by reducing short and long term complications of MCSD therapy. The Quality Assurance Report contains information from your site compared to the overall Intermacs experience. To facilitate this comparison only primary prospective patients are analyzed. Exclusion reasons from the QA report include; Retrospective patients (implanted prior to site activation), Patients whose first implant in Intermacs is not their primary implant, Patients only receiving an RVAD, or Pediatric patients entered into Intermacs prior to the launch of Pedimacs. Transfer patients and their subsequent experience are analyzed in the report for the site that implanted the primary implant. Session I: Web Based Reporting: What You Can Get From the Database

17. Who receives the Quality Assurance Report? Site Administrators When do I receive the Quality Assurance Report? Quarterly: Session I: Web Based Reporting: What You Can Get From the Database Calendar QuarterReport Coverage Stop Date Report Distribution Deadline Q1March 31stJune 30th Q2June 30thSeptember 30th Q3September 30thDecember 31st Q4December 31stMarch 31st

19. The QA Report is available for you to download to your secure server or desktop. Please note this report contains PHI and should be handled following all HIPAA guidelines.

20. Where do I go to get this report? Session I: Web Based Reporting: What You Can Get From the Database Step 1:

21. Where do I go to get this report? Session I: Web Based Reporting: What You Can Get From the Database Step 2:

22. 22 Information Security Agreement when Downloading Intermacs data

23. Session I: Web Based Reporting: What You Can Get From the Database

24. The list below are reasons why a patient from your site is excluded from the Quality Assurance Report (QA). Retrospective patients Patients with a prior history of MCS (LVAD,RVAD,TAH) Pediatric patients Patients that have transferred to your site Patients with missing implant dates. Session I: Web Based Reporting: What You Can Get From the Database

25. Exhibit 1: Primary and Subsequent Device Counts The following tables list the number of implants at your site and Intermacs overall by device sequence (primary, secondary, etc.) and time period. NOTE: Subsequent analysis in this report evaluate only primary devices unless specified otherwise. Session I: Web Based Reporting: What You Can Get From the Database

26. Quality Assurance Report: 6 Minute Walk Session I: Web Based Reporting: What You Can Get From the Database

27. Adverse Event Rates (INFECTION) Session I: Web Based Reporting: What You Can Get From the Database

28. For examples of the Data Quality and Quality Assurance, Visit our website at: http://www.uab.edu/medicine/intermacs/reports/statistical-reports http://www.uab.edu/medicine/intermacs/reports/statistical-reports Session I: Web Based Reporting: What You Can Get From the Database

29. Session I: Web Based Reporting: What You Can Get From the Database

30. Thank you Statistical Reporting Team! Ryan, Devin and Maceo Session I: Web Based Reporting: What You Can Get From the Database

31. Questions about accessing your reports: Questions about report access? mclegg@uab.edu Session I: Web Based Reporting: What You Can Get From the Database