QA Report Exhibit 26
Please disregard Exhibit 26 in the 2020 Q4 Quality Assurance Report. Reports will be rerun and uploaded by April 30th.

Intermacs Version 5.1

On August 13, 2018, version 5.1 of the Intermacs Web Based Data Entry system was released. It contains major upgrades to the cosmetic look of the system as well as a re-design of the background processing of devices, which will facilitate faster corrections to data entry errors. This is purely a functional upgrade to the system, and does not modify the data collection elements or usage of the system in any way, and therefore no re-training is required. A brief list of changes is as follows:
  • New cosmetic look for the entire site, including more consistent navigation elements, buttons, and layout.
  • More user information, such as current role, last login date & time, etc., which is viewable from all pages in the system.
  • Redesigned report menu, to assist new and experienced users in downloading reports and easily seeing what features are available.
  • New layout of the Patient Summary, to more clearly indicate status of each form and allow for future additions.
  • Devices details are stored in a more flexible format, which does not affect entry, but allows for greater ease of changes.

New Dashboard View
Intermacs 5 1 Dashboard Screenshot

New Patient Summary
Intermacs 5 1 PTSummary Screenshot

New Form View
Intermacs 5 1 Form Screenshot

Feedback from users of the WBDE is highly encouraged, and all comments and questions will be reviewed and evaluated.  Additionally, the new system will allow faster turnaround time for system changes, so any issues should be reported immediately and will be corrected as soon as possible.
Heartmate 3 is now available as a device brand option in Intermacs.

Please enter commercial Heartmate 3 implants into Intermacs (i.e., those patients not currently being enrolled into the MOMENTUM 3 CAP study).
Patient Clinical Summary

Intermacs is happy to announce the addition of a new feature to the Web-Based Data Entry system, Patient Management. The Patient Management tool provides an easy to read summary of clinical characteristics on a single patient. The Patient Management tool is also accessible from the patient summary screen. The patient management report will include key data that has been entered into the Web-Based Data Entry:
  1. Demographics
  2. Pre-Implant
  3. Primary Implant in Intermacs
  4. Events (Rehospitalization, Infection, Bleeding, Device Malfunction, Neurological Dysfunction, Other Serious AE, Explant, Death)
  5. Quality of Life
  6. Laboratory Values
  7. Medications
  8. Zoning variables (Right Heart Failure, Hemolysis, Hypertension)
Click here for more info.
Transfer Process

If a patient transfers his/her care, the last date of medical contact should be used as the transfer date. This could be either a date of the last clinic visit, hospitalization or phone call.

Guidelines for the Publication and Presentation of Data for Intermacs

Accessing Intermacs Data by Industry for FDA Post Market Studies
Right Heart Failure

Right Heart Failure is a complex condition in the Intermacs population. The Registry’s Right Heart Failure Task Force would like to capture peripheral edema, ascites and NYHA Class on the pre-implant form for these patients. Intermacs Centers are able to download a list of their patients directly from the web based data entry system to confirm peripheral edema, ascites or NYHA Class.

Protocol 5.0 Release - October 17, 2016.

  • Centers that are exempt from Institutional Review Board/Ethics Board (IRB/EB) review should follow their own institution’s policies for implementing Protocol 5.0.
  • Centers that require Institutional Review Board or Ethics Board approvalmust provide documentation of IRB/EB approval notice prior to Monday, October 17, 2016 in order to access the web based data entry system.

New documents include:
  • Protocol 5.0
  • Manual of Operations and Procedures 5.0
  • Record of Revisions
  • List of New Elements Added with the Implementation of Protocol 5.0
  • Stroke Scale Instructions
  • National Institutes of Health Stroke Scale Questionnaire

The Intermacs Regulatory Team is available to assist with any questions you may have.

Intermacs / Pedimacs Quarterly Center Reports and Datasets

The 2016 Quarter 1 Intermacs / Pedimacs Quarterly Center Reports will be uploaded to the Intermacs / Pedimacs Web Based Data Entry Systems (WBDE) the week of June 27, 2016. Site Administrators at centers with an “Active” status will be able to download these materials directly from the WBDE by clicking on the “File Delivery” page. Please share these reports with your site PI and VAD teams.

New Reports:
  • Intermacs “Recent Year” Quality Assurance Report – In addition to the standard quarterly quality assurance report Intermacs has added a new report limited to patients implanted since the beginning of the last complete calendar year (January 1st, 2015). We hope this comparison using a contemporary cohort will facilitate tracking changes in patient population and outcomes at your site.

  • Pedimacs Federal Partners Report - Intermacs is posting the new Pedimacs Federal Partners Report on the Intermacs website (www.intermacs.org/reports/public-statistical-reports). This report contains an overview of Pedimacs patient characteristics and outcomes for the entire registry.

For questions regarding reports please contact Maceo Cleggett (INTERMACS-Reports@uabmc.edu). For questions regarding site datasets please contact John Pennington (johnpennington@uabmc.edu).
A trio of new Pedimacs articles are currently available online at The Journal of Heart and Lung Transplantation.

http://www.jhltonline.org/, May-2016 (Volume 35, Issue 5)

FDA Safety Announcements

SynCardia TAH-t Companion 2 Driver System

Serious Adverse Events with LVADS

Information Security Update for the Web Based Data Entry System

Due to the changes from Microsoft support for older versions of Internet Explorer (IE), the Intermacs Web Based Data Entry (WBDE) will no longer be supporting older versions of IE (Ver. 8, 9, 10).

Microsoft has stated that as of January 12, 2016 they will no longer provide security updates or technical support for older versions of Internet Explorer. Because of this, the Information Security Department is requiring that connecting browsers will need to be upgraded to the latest version of browser of IE or the latest version of Google Chrome, or Mozilla Firefox.

These changes will require that our customers will need to either update their systems IE browser to either the latest version of Microsoft IE 11, or install an alternate browser, such as the latest version of Google Chrome, or Mozilla Firefox.

While we at Intermacs understand that this may cause some issues with your IT department, these changes are being put into effect to protect the sensitive data being entered by your site and systems from possible vulnerabilities that may be exploited by malware written for unsupported browser versions.

Please note that these changes will take effect on February 29, 2016, after that date, older versions of IE will be blocked from entering data into the WBDE.

To eliminate any delays in entering data due to browser incompatibilities please contact your specific IT department as soon as possible for assistance in upgrading your web browser.
Are Blood Clots in Patients with Heart-Assist Pumps Decreasing or on the Rise in 2015?

A Difficult Question to Answer, According to Studies Published in The Journal of Heart and Lung Transplantation

MDR Notice

The Food and Drug Administration (FDA) has withdrawn the Single Reporter Exemption granted to Intermacs in 2007 and Intermacs has terminated all Medical Device Reporting (MDR) related activities.  Requirements for reporting MDRs can be found on the FDA website, www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.  Participating centers should continue to enter data in the Intermacs web based data entry system as usual.

Site Specific Datasets Are Ready for Download

Since 2011, Intermacs has provided participating centers with datasets of their own data via a request form downloaded from the Intermacs website. Due to significant increase in the number of requests, we have designed a method to more efficiently distribute these datasets. Our programmers and regulatory staff have completed the process for generating quarterly SAS (Statistical Analysis System) site specific datasets automatically for our participating centers for their adult patients. Site Administrators will have the option to download their site’s SAS datasets each quarter in the same manner they obtain the current Intermacs Quarterly Site Reports.
New Web Based Data Entry System!

On June 2, 2014, a new, totally revamped version of the INTERMACS (adults) web based data entry system went live (please see below for a complete description of the details of the new system). During this initial “burn in” phase of the new system, many of you have identified issues (bugs) with both the new log-in system and the data entry system itself. We greatly appreciate your patience during this initial period and we sincerely want to minimize your frustrations. If you have any issues with any aspect of the new log-in process, please contact Chase Lenderman (205-975-3902, chaseter@uab.edu) or Maceo Cleggett (205-975-3901, mclegg@uab.edu). If you have any issues with the data entry system, please continue to contact your INTERMACS nurse monitor. We will answer phone calls as soon as possible and we will respond to emails the same day or early the next day. Our goal is to provide the most useful INTERMACS system possible while quickly responding and resolving identified issues. Thank you.
Protocol 4.0 Release - June 1, 2014.

Intermacs/Pedimacs has undergone several changes recently which will be implemented June 1, 2014. The primary change reflects the transition of Intermacs from a research registry to a Quality Improvement registry which we believe will no longer require Informed Consent. Below is a list of changes, new documents and suggestions for a smooth transition. Please contact the Intermacs Data Coordinating Center if you have any questions.

New Protocol
The new Protocol 4.0 is to be used for both Intermacs and Pedimacs. New Users' Guides
The Users' Guide has been updated and separated into two Guides, one for Intermacs and one for Pedimacs.

Waiver of Informed Consent and Authorization
Intermacs has provided a Justification letter describing why we believe a waiver of consent and authorization is appropriate for the registry.

List of Changes
A list of Additions and Deletions describing the changes is available.

Revised Data Collection Forms
New Intermacs Data Collection Forms are available. Pedimacs Data Collection Forms will be available in July.

New security measures
A two-factor authentication application which uses a phone or hardware token will be used to verify the user’s identity. Instructions will be provided to Intermacs members.