#HHSN268201100025C
INTERMACS
Interagency Registry for Mechanically
Assisted Circulatory Support
INTERMACS Operating Instructions
Title:
Overview of Statistical Reporting: Public/Complete
Document Number:
IOI-10-101-V1
Document Storage Location:
M:\INTERMACS 2011-2015\10 Statistical Reports\2 IOI Public\IOI-10-101-V1 Overview Of Statistical
Reporting.Docx
Author:
Position:
Ryan Cantor
Statistical Reports Director
Approved by:
Position:
Ryan Cantor
Statistical Reports Director
Approved Date:
Effective Date:
Last Edited Date:
07/19/2013
07/19/2013
07/19/2013
Page 1 of 5
IOI-10-101-V1
Overview of Statistical Reporting
Overview of Statistical Reporting
1. PURPOSE AND SCOPE
The purpose of the DCC Statistical Reports Department is to provide descriptive summaries of
patients, devices, and outcomes on a routine basis to a variety of stakeholders.
Statistical Reporting from the DCC reaches a wide audience. There are several registries
(INTERMACS, pediMACS and MEDAMACS) and several audiences (Federal Partners, Industry, and
Sites) including other internal departments. Major efforts have been taken to streamline the
statistical reporting processes to run with parallel processes across registries and across reports.
These techniques encourage efficiency, accuracy, and ease of process maintenance.
2. PERSONNEL / RESPONSIBILITIES
The key roles and tasks for the Statistical Reports Department are:
Statistical Reports Director – manages the creation and distribution of all routine DCC statistical
reports. Tasks include the oversight of all statistical programming used in the process, training of
staff, documentation, and interfacing with other departments to ensure the most accurate and
timely reports are generated
Report Distribution Manager – organizes tasks involved with report validation and distribution and
directly communicates with sites regarding reporting questions
Programming Assistant / Report Support – supports the generation of reports through a variety of
tasks including process maintenance, documentation, and SAS job submission
Programming Assistant / Data Management Support – supports both the Data Management
Department and Statistical Reports Department in maintaining routine data processing duties
Medical Device Reporting (MDR) Manager and Support Staff – MDR processing and submission
duties to the FDA and industry
Page 2 of 5
IOI-10-101-V1
Overview of Statistical Reporting
3. PROCEDURE
The following tables list the INTERMACS Statistical Reports
INTERNAL REPORTS
Report
Registry Compliance Report
Industry Billing Report
Distribution
Quarterly
Quarterly
Audience
Nurses for Audits
Finance
INDIVIDUAL REPORTS
Report
Federal Partners Report
CMS Report
Industry Report – Thoratec
Industry Report – SynCardia
Industry Report – HeartWare
NHLBI Report
Distribution
Quarterly
Quarterly
Quarterly
Quarterly
Quarterly
Annually
Audience
Federal Partner, OSMB, Public
CMS
Thoratec
SynCardia
HeartWare
NHLBI
SITE REPORTS
Report
Site Reports
Quality Assurance (QA)
Data Quality (DQ)
Distribution
Quarterly
Audience
Sites
The following tables list the pediMACS Statistical Reports
INDIVIDUAL REPORTS
Report
Federal Partners Report
Distribution
Quarterly
Audience
Federal Partner, OSMB, Public
SITE REPORTS
Report
Site Reports
Distribution
Quarterly
Audience
Sites
Page 3 of 5
IOI-10-101-V1
Overview of Statistical Reporting
A general outline of the steps used to generate and distribute reports is provided in the figure
bellow.
Page 4 of 5
IOI-10-101-V1
Overview of Statistical Reporting
4. SCHEDULE
Reports are generated on a quarterly basis. After the end of a reports coverage date, an additional
month of data is collected to allow site coordinators to enter all forms that apply to the report. The
Data Management Department receives raw data and processes the analytical datasets used in the
reports. Reports are drafted and edits and new exhibits are implemented. Finally in the last week of
the quarter the reports are distributed.
Quarterly Report Schedule:
Calendar
Quarter
Report Coverage
Stop Date
Dataset* Report Distribution
Deadline
Q1
Q2
Q3
Q4
March 31st
June 30th
September 30th
December 31th
April
July
October
January
June 30th
September 30th
December 31th
March 31th
* Reports are generated from datasets one month after coverage stop date, to allow time for data
entry.
5. SUPPORTING DOCUMENTATION AND RESOURCES
Complete step by steps instructions for all DCC Statistical Reporting processes can be found in the
internal document IOI-10-001 Statistical Reporting.
Revision
01
Author
Ryan Cantor
Revisions Made
New IOI
Date
07/019/2013
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