STS Expands the Scope of the National Database

On January 17, 2008, the Society of Thoracic Surgeons (STS) sent out a blast e-mail explaining the expanded scope of the STS National Database:

Dear STS Database Participant:

We are writing to update you about STS plans to significantly expand the scope of the STS National Database and enhance the utility and capabilities of the Database with the incorporation of HIPAA Compliant Unique Patient, Surgeon, and Hospital Identifier (Identifier) Fields.  A blast e-mail announcing these plans was sent on April 24, 2007 and the Identifier Fields will be added to the STS Adult Cardiac Surgery Database beginning January 1, 2008. Similar fields will be added to the STS General Thoracic Surgery and Congenital Heart Surgery Databases during the next specification upgrades of these Databases. 

As discussed in that April 24, 2007 e-mail, the rationale for the incorporation of these Identifier Fields into the Database is to enhance its ability to function as a tool for longitudinal follow-up of patients, and specifically, to enable the Database to track the long-term survival and functional status of patients post-operatively. In order to achieve that goal, assigning patient identifiers to all patients within the Database is necessary.  This expansion will potentially allow the Database in the future to:

• Verify mortality data with statewide and national death registries, including the National Death Index and Social Security Death Index.
• No clinical information leaves the STS National Database.
• Link STS data with other subspecialty databases, including the American College of Cardiology National Cardiovascular Data Registry (NCDR) and the Virtual Pediatric Intensive Care Unit Database System (VPS Database) of the Pediatric Cardiac Intensive Care Society.
• Any data linking agreements will require strict adherence to HIPAA  privacy regulations.
•  Link and follow patients when they have multiple operations in different institutions - a common occurrence in congenital heart surgery, for example.
• Link and follow patients who have had operations in more than one of our three databases (Adult Cardiac Surgery, General Thoracic Surgery, and Congenital Heart Surgery).
• Perform long-term follow up and generate Kaplan Meier Survival curves from our data.

Duke Clinical Research Institute (DCRI) has obtained Duke Institutional Review Board (IRB) approval for the inclusion of identifiers in the Database.  This approval covers submissions of Identifier Fields by participants as well as the data aggregation and analyses performed using those data.  There is no need for individual participants to seek separate approval from their own institution's IRB.  Nevertheless, to assist those institutions wishing to do so, STS has prepared supporting documentation that clearly shows that our plans to incorporate Identifier Fields into the STS Database are compliant with both the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and "The Common Rule."  (The Common Rule is a subpart of the United States Department of Health and Human Services regulations, title 45 - Human Subjects Research.  The Common Rule is the standard of ethics to which any government-funded research in the US is held. At some institutions, the Common Rule governs IRBs for oversight of all human subjects research.)  STS Database Participants can request this supporting documentation via e-mail from the following address:  phi@sts.org.  The STS will send the following legal, technical, and bioethical documents:

(1) A memorandum from STS outside legal counsel that provides an informal HIPAA analysis related to STS National Database collection of protected health information (PHI).  (This document is available today.)

(2) A letter from the Chair of the Duke IRB confirming that the Duke IRB has approved the incorporation of identifier fields into the STS Database and outlining the operational strategy that DCRI will utilize to accomplish this task. (This document will be available in January 2008.)

(3) A document that addresses the applicability of HIPAA and the Common Rule to the STS Database and related Frequently Asked Questions (FAQ).  This document will describe the technical strategies implemented to assure safety of the data and compliance with HIPAA and The Common Rule.  (This document will be available in January 2008.)

(4) A summary of the bioethical arguments surrounding the STS approach.  (We anticipate that this document will be available in the first quarter of 2008.)

As you know, STS has a Business Associate/Data Use (BA/DU) Agreement with each Database Participant, which complies with HIPAA, thereby protecting the security and privacy of patient data.  This agreement also permits STS and its data warehouse and analysis center, DCRI, to incorporate fully-identified PHI into the Database for purposes of participants' health care operations, including data aggregation, quality improvement, outcomes evaluation, and development of clinical guidelines.  Up to now, STS has accepted only submissions of limited data set information into the Database, rather than fully-identified PHI.  The addition of identifiers to the submitted information will not change the purposes for which the information would be used, that is, to support healthcare quality improvement efforts.  Meanwhile, research may be performed using de-identified aggregated data derived from fully-identified PHI.

The collection of data using Patient Identifiers will simply permit STS to provide Database Participants with an enhanced range of information to support their health care operations.  Therefore, the assignment of Identifiers to data collected from Database Participants will be covered by existing BA/DU Agreements. The addition of the Identifiers will not add significantly to the amount of information submitted on each patient, and there will be no other requirement, at this time, for the acquisition of follow-up information.

We firmly believe that this new and enhanced capability for long-term follow-up will be a valuable addition to the functions of the STS Database.  We appreciate your continued participation in the Database and look forward to providing you with data analyses that will be of even greater value to your quality improvement efforts.

Sincerely,

For The Society of Thoracic Surgeons

John E. Mayer, Jr, MD
President, The Society of Thoracic Surgeons

Fred H. Edwards, MD
Chair, Workforce on National Databases

Jeffrey P. Jacobs, MD
Chair, Congenital Heart Surgery Database Task Force
Chair, STS Database Unique Patient Identifier & Longitudinal Follow-Up Subcommittee