Guidance aims for safer use of lab data in EHRs

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Kevin B. O’Reilly

March 2014—A wide-ranging set of recommended health information technology safety practices recently issued by the Department of Health and Human Services is likely to accentuate the essential role that pathologists and laboratory leaders play in minimizing the adverse consequences of health IT.

Pathologists and lab experts involved with developing the guidance say it could serve as a North Star for how health care organizations can improve IT safety, especially with regard to better test tracking and results display. But some of the functionalities the recommendations call for are not yet widely available, and the recommended practices could represent a big implementation challenge for laboratories.

The recommendations, dubbed Safety Assurance Factors for Electronic Health Record Resilience, were released as nine separate self-assessment guides encompassing 158 best practices that are designed for health care organizations to complete in consultation with their IT vendors. These so-called SAFER guides were released in January by the HHS Office of the National Coordinator for Health Information Technology, or ONC.

Teresa Darcy, MD, served as a pre-release reviewer for the SAFER guide that focuses on test results reporting and followup. She is medical director for clinical laboratories at the University of Wisconsin Hospital and Clinics.

“The labs should look at this as a good roadmap, a kind of checklist to insist that patients are safer,” she says.

The guidance comes in response to rising concern over how the move from paper to electronic systems is leading to instances of IT-related patient harm. A November 2011 Institute of Medicine report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” called on the federal government to develop a system to monitor these IT hazards and work to prevent them. The SAFER guides represent one part of the ONC’s broader response, detailed in its July 2013 “Health IT Patient Safety Action and Surveillance Plan.” The guides are available as downloadable, interactive PDFs at www.healthit.gov/saferguide. They were beta-tested with a handful of inpatient and outpatient sites in Texas and California.

The SAFER guides are designed to inspire productive, multidisciplinary, interdepartmental collaborations on how to reduce IT-related hazards, says Hardeep Singh, MD, MPH, one of three experts who developed the checklists under contract from the ONC. He is associate professor of medicine at Baylor College of Medicine and chief of the Health Policy, Quality and Informatics Program at Michael E. DeBakey Veterans Affairs Medical Center.
“It’s not an us versus them situation,” he says. “It’s about people coming together, talking about EHR safety, and bringing whatever it takes to improve patient safety and make patient safety the priority. That means having meaningful conversations with my vendor, with my lab person, maybe with my quality officer, maybe my office manager and CEO to make sure that what we do is right. Now that we have this technology in medicine, we have to figure out how to make it work. We can’t go back to paper.”

The guides cover a sweeping set of areas relevant to a health care organization’s approach to IT safety issues, dealing with topics such as organizational responsibilities, contingency planning, system interfaces, system configuration, clinician communication, patient identification, and computerized physician order entry with clinical decision support. Each of these checklists includes guidance that touches upon the laboratory world.

For example, the patient identification guide recommends that the correct ID be verified at key points in the care process, including test order entry. The CPOE guide, meanwhile, calls for the EHR to allow cancellation and acknowledgment of receipt of laboratory tests and other orders. The CPOE checklist also says the IT systems should automatically suggest and group together corollary or followup tests so that changes are reflected when the original order is rescheduled, renewed, or discontinued. To help address alert fatigue, the CPOE guide also says pop-ups should be limited to laboratory and other orders related to high-risk, high-priority conditions.
The SAFER guide on test results reporting and followup includes 23 recommended practices that target how tests are ordered, stored, structured, reported, acknowledged, amended, flagged, tracked, and followed up on within the EHR. Among other things, the guide recommends that:

• Test names, values, and interpretations for laboratory results are stored in the EHR as structured data using standardized nomenclature.
• Predominantly text-based reports (e.g. radiology or pathology reports) have a coded (e.g. abnormal/normal, at a minimum) interpretation associated with them.
• Display of results (e.g. numeric, text, graphical, or image) should be easily accessible, clearly visible (and not easily overlooked), and understandable. For other recommendations, see the Box.

The need for this kind of organizational self-assessment of the test results reporting and followup process seems clear, as studies have found that health IT is not eliminating paper-related mixups and sometimes creates new problems. A study led by Dr. Singh found that office-based physicians using the EHR at a VA facility failed to acknowledge alerts about clinically meaningful abnormal imaging results 18 percent of the time.