Safety concerns took center stage at the HIT Policy Committee meeting today in Washington, D.C., as Certification and Adoption Workgroup Co-chairs Paul Egerman and Marc Probst reported their recommendations on those issues to the full committee.
The workgroup’s report was a refinement on an earlier presentation Egerman, a software entrepreneur, and Probst, CIO at Utah-based Intermountain Healthcare, gave after receiving testimony about HIT-related patient safety incidents on Feb. 25. First and foremost, they recommended creating a national transparent database or information system which could house all reports of incidents. But the technology architecture of such a database was barely discussed, as issues like privacy and liability took the lead. Only with those two issues well in hand would healthcare providers and others report incidents without fear of reprisals.
For example, the workgroup endorsed the concept of a “feedback button” built right into the user interface of HIT applications, so individuals wouldn’t have to search for the proper agency to contact with their concerns. Also, it was recommended that an environment which encouraged reporting of “near misses” — where a error could have caused major harm, but didn’t — be created.
In an extensive discussion, the committee debated what roles various entities and organizations could play in the project — from Patient Safety Organizations (PSOs) to the Food and Drug Administration —and the specific protections each agency afforded whistleblowers.
However Egerman and Probst made a point of saying that their workgroup decided to recommend outcomes, not the specific agencies which should construct the program. “We decided to just define what was needed, not how it must be implemented,” Egerman said. “We indicate we want a national information system with oversight, without specifying who and how.”
They recommended that components of the system should include:
- Confidential reporting with liability protection (e.g., whistle-blower protection)
- Ability to investigate serious incidents
- Provision of standardized data reporting formats that facilitate analysis and evaluation
- Receive reports from patients, clinicians, vendors, and healthcare organizations
- A reporting process to cover multiple factors including usability, processes, and training
- Receive reports about all health information technology (HIT) systems
- Receive reports from all Software Sources (vendors, self-developed, and open source)
- Ability to disseminate information about reported hazards
The Workgroup additionally recommend that ONC commission a formal study “to thoroughly evaluate HIT patient safety concerns, and to recommend additional actions and strategies to address those concerns.”
In a related discussion, the workgroup recommended that the industry be notified of Stage 2 and 3 Meaningful Use criteria at last 18 months before the eligibility period for those phases of the program began. However that point was quickly taken up by Director of the CMS Office of e-Health Standards and Services Tony Trenkle, who said that backing up the finalization of subsequent stages by that much time would leave little opportunity to hear about issues with Stage 1.
“Although this sounds good on paper, there will not be much time to get any feedback on 2011 responses and concerns that come up. That would be my major issue,” he said.
Probst quickly retorted, “But the other problem is that we then pass the buck to someone who has to implement on the back end if we don’t get the requirements out.”