Message to ONC

EHR Certification Methods Fail Physicians, Patients

January 27, 2015 01:25 pm News Staff

Many of America's physicians are unhappy with the performance of their electronic health record systems (EHRs), and the medical organizations that support those physicians recently expressed growing concern about the federal EHR certification process.

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In a Jan. 21 letter(9 page PDF) to Karen DeSalvo, M.D., M.P.H., director of the Office of the National Coordinator for Health Information Technology (ONC), the AAFP and many other prominent medical groups and other stakeholders noted that members often described their EHR systems as "cumbersome" and unable to meet workflow needs.

Rather than making their jobs easier, physicians reported that EHRs "decrease efficiency and have limited, if any, interoperability," said the letter.

"Most importantly, certified EHR technology can present safety concerns for patients. We believe there is an urgent need to change the current certification program to better align end-to-end testing to focus on EHR usability, interoperability and safety," the organizations told DeSalvo.

Outlining Necessary Changes

The letter, which was signed by 41 organizations representing hundreds of thousands of physicians nationwide, urged the ONC to consider seven changes to the current EHR certification process:

Story Highlights
  • The AAFP joined 40 other medical organizations in asking the Office of the National Coordinator for Health Information Technology (ONC) to change processes for electronic health record (EHR) certification.
  • In a letter to ONC head Karen DeSalvo, M.D., M.P.H., the groups asked for a renewed focus on EHR usability, interoperability and patient safety.
  • The letter put decoupling certification from the EHR meaningful use program at the top of a seven-point list.
  • decouple EHR certification from the EHR meaningful use program,
  • weigh alternative software testing methods,
  • create greater transparency and uniformity in user-centered design and process results,
  • incorporate "exception handling" and scenario-based testing,
  • develop "consolidated clinical document architecture" guidance and test to support the exchange of health information,
  • seek feedback from physicians and other stakeholders, and
  • increase educational opportunities on EHR implementation.

Delinking Meaningful Use, Certification

HHS' meaningful use program, designed to spur physician implementation and use of EHRs, drew particularly sharp remarks. "Unfortunately, we believe the meaningful use (MU) certification requirements are contributing to EHR system problems, and we are worried about the downstream effects on patient safety," said the letter.

The organizations pointed out that many meaningful use objectives place "excessive burdens on physicians and their practices" because they tie successful compliance to measures that require "specific patient participation, cumbersome data collection and complex exchange methods."

"We believe ONC should reconsider the role and composition of its certification program to address patient safety risks, usability and interoperability," said the letter. Physicians must have confidence in the usability and safety of their certified EHRs so they can focus on caring for their patients.

Prioritizing Testing, Transparency

Regarding transparency and changes to EHR certification testing, "We believe that certification should not only show that an EHR can meet MU objectives and measures but that tested systems can support interoperability and ensure patient safety," said the organizations.

Furthermore, "We believe the best way to ensure high-performing EHRs and to minimize errors is to rigorously test them against a multitude of clinical scenarios that represent the variety of workflows seen in acute and ambulatory care settings," they wrote.

Exception handling -- identifying exactly how software would handle human error such as entering inaccurate information -- should be used in tandem with testing in clinical scenarios, said the organizations.

"Currently, EHR certification testing is done in controlled environments that often do not mimic the flow of medical information in real-word clinical settings and is not capable of identifying safety-related issues," said the letter. Of equal importance is user-centered design -- or an EHR vendor's willingness to consider product effectiveness, efficiency and user satisfaction in a product's design.

"It is vital that proper UCD (user-centered design) techniques are adhered to so that EHR vendors incorporate both user interface and cognitive workflow design in the development of their products," said the letter. Likewise, scenario-based testing is tied to real-world testing and captures the way physicians need to use the product; it exposes design errors and verifies the flow of data through than EHR.

The organizations pointed out to DeSalvo that, "Although an ONC Federal Advisory Committee explored the use of this framework in the past, scenario-based testing was excluded as a requirement for 2014 EHR certification."

Ensuring Interoperability

"Ensuring electronic health information follows patients during the transition of care is one of the most sought after, yet the least successful, exchange paradigms in health care today," the organizations told DeSalvo.

The certification procedure for transition of care tests whether ambulatory and inpatient EHR technology can receive, display and incorporate summary of care records. However, EHR vendors have options when it comes to following the official consolidated clinical document architecture (C-CDA) clinical guidance.

"This variability in C-CDA construction causes a mismatch between the sending and receiving EHRs and limits the usefulness of information that is actually viewed by the physician and other medical professionals at the point of care," said letter.

Furthermore, the lack of consistent implementation guidance has "led to poor interoperability, placed patients at risk and created significant costs to our health care system."

Seeking Stakeholder Feedback, Education

The letter called on the ONC to convene a "software certification learning session" that would involve individuals from a variety of fields with experience in producing, testing and certifying software. The organizations urged DeSalvo to regularly convene such sessions to further the development and refinement of certification methods and scenarios.

The letter also asked for more education for physicians and other EHR users on how to get a system up and running. "ONC should routinely request implementation best practices from the field," and disseminate information back through a variety of channels including the ONC website, blogs and educational sessions, said the organizations.

The groups urged DeSalvo to consider a semi-annual roadshow to disseminate ideas about implementing and deploying EHRs. "As the very least, educational activities should be conducted after each new EHR certification version," the letter concluded.

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AAFP to ONC: Ease Burdens, Address Standing Goals


Q&A With Steven Waldren, M.D.
Quest for EHR Usability, Interoperability Fuels AAFP's Technology Team


Ask the Expert
Final Rule for Meaningful Use Adds Flexibility for 2014, but Implementation Still a Stretch


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