Guidance aims for safer use of lab data in EHRs

Nearly eight percent of the time, the ordering doctors failed to take action on the results within a month. More than a quarter of the tests that initially were overlooked resulted in the diagnosis of a new disease, with 42 percent of those being cancer diagnoses (Arch Intern Med. 2009; 169(17): 1578–1586).

Many of the SAFER guide recommendations are aimed at using computing power to help prevent ordering physicians from overlooking results, Dr. Singh says.

“We want to separate the signal from the noise,” he says. “We need to figure out how to code that signal so the computer knows what’s the signal versus what’s noise.”

Then there are the cases where seemingly simple formatting issues lead to big problems, says Megan E. Sawchuk, MT(ASCP), a health scientist in the Centers for Disease Control and Prevention’s Division of Laboratory Program, Standards, and Services. Sawchuk and her colleagues on the LabHIT Team reviewed the SAFER guides before they were released for use. Through their work, Sawchuk is familiar with a case in which the EHR truncated the text in a report. Instead of saying “No cancerous cells seen,” as was intended, the “no” was truncated so that the text read, “Cancerous cells seen.”

At one major academic medical center, the IT vendor used an exclamation point as a flag for critical values. This was placed in front of a glucose result that was abnormally low. But that exclamation point was mistakenly read as a 1 preceding the abnormally low number, making the result appear to be above normal. The patient received insulin and had an adverse outcome, Sawchuk says.

“That’s a great example of a very small formatting issue that probably made a lot of sense to the people who programmed the system, but when it was implemented it was not really usable in the clinical setting,” Sawchuk says.

“The majority of the recommended practices in the SAFER guides are elements that laboratory professionals would already expect to see on their test reports,” she adds. “The laboratory has gone to great effort and pain over numerous decades to format lab reports in ways that are highly readable and interpretable by the clinician. But now we’re converting to an almost 100 percent electronic environment and the lab is no longer really in charge of the format that’s getting transmitted downstream. The SAFER guides empower the laboratory professionals to step out of the lab and see how things are actually being implemented, and also to be able to identify the issues and communicate them to their internal leadership, their CIO, and EHR vendor.”

Dr. Darcy, from the University of Wisconsin labs, also notes the difficulty with properly transmitting results from the laboratory information system to the EHR.

“Laboratorians have to be in the electronic record looking at lots and lots of results when building it into the test environment, and after production,” she says. “So when we get a call from the clinician that they didn’t get a result, we have to see what they saw. Something that works well in the lab system doesn’t necessarily translate well into the electronic record.”

In a recent medical journal article she co-wrote, Dr. Darcy noted several other examples of problems with displaying lab results. For example, many EHRs do not allow commas and don’t justify columns of data at the decimal point. This makes it hard to interpret numeric data. “A tumor marker of a result of 2220 may be misinterpreted as 22220 and vice versa,” the authors write (Walz SE, et al. Clin Lab Med. 2013; 33(1):183–194).

Noah Hoffman, MD, PhD, says many of the ONC recommendations will pose a challenge to labs because they are items that are outside their direct control and sometimes not yet technically possible. Dr. Hoffman is assistant professor in the Department of Laboratory Medicine at the University of Washington Medical Center and associate director of its informatics division.

“Many of these imperatives really force coordination between the lab, and providers, and other users of the EHR system, which is probably the intent,” he says. “Assessing the feasibility of these things will depend on who your partner is and whether you’re working toward the same ends.”

Addressing the problem of too many test result alerts is one example where collaboration will be essential, Dr. Hoffman says.

“The directive to reduce alert fatigue is important, but it’s not a trivial undertaking to work with the providers who will be receiving the results to arrive at mutually agreeable criteria for sending notifications,” he says.

“Many labs have the concern that providers do err on the side of only looking at results that are flagged as positive or abnormal,” Dr. Hoffman adds. “That’s a very crude measure of whether something is worth looking at. I think our lab has the concern that important negative results might not be reviewed.”

Another significant challenge is the recommendation to use coded names for all send-out tests, which are often now categorized as miscellaneous reference tests. “To have a coded test name—that implies you’ve created a battery with the coded test names and corresponding entries. Creating a defined test is a process. The overhead of doing that for one-off tests is pretty high,” he adds. “Right now, it’s just too tall an order.”

Dr. Hoffman notes that the separate recommendation to send more than 40 percent of results as structured data is already a core requirement for stage one of meaningful use under the Centers for Medicare and Medicaid Services’ EHR incentive program. Despite the requirement, a February ONC data brief found that one-third of about 5,000 randomly sampled labs surveyed in May 2013 lacked the capability to electronically send results in structured format to an EHR.

In extensive comments, the Electronic Health Records Association—which represents EHR vendors—expressed concern that some recommendations were not technically feasible. For example, the ONC says that all critical result details should be displayed on one screen without scrolling to allow for easier interpretation. But, the EHRA notes, “This is device dependent and not all form factors will support a full display.”

Sarah Corley, MD, chairs the association’s patient safety workgroup and is chief medical officer at IT vendor NextGen Healthcare. She says the SAFER guides should evolve in consultation with EHR vendors and as technology changes.

“We think this is a great idea,” she says of the ONC guidance. “But some of the recommendations include functionality that isn’t widely available right now. For the most part, the recommendations are what vendors have been recommending for our clients. We applaud having a neutral party recommend these items to have safe, effective implementation of IT use.”

In response, Dr. Singh says he is aware that some of the recommendations may depend on IT functionalities that are not yet available.

“That’s the point. The systems have to get better and we have to have innovations,” he says.

Better IT systems should dovetail with laboratory professionals’ efforts to improve quality assurance, says Kim Futrell, MT(ASCP), products marketing manager at LIS vendor Orchard Software.

“The lab down in the basement is doing QA on everything they can think of, but it rarely reaches beyond the lab. Having QA processes in place can only make EHR usage better and increase patient safety,” she says. “For example, followup on items such as clinician use of results in the EHR, and results sent to the wrong clinician, absolutely needs to be reviewed and acted upon. How can you fix these errors and processes if you aren’t tracking them?”

Laboratory leaders have an imperative to take a greater, hands-on role in how the EHR is chosen, implemented, and monitored for its impact on lab quality, safety, test utilization, and more, says Walter H. Henricks, MD. He is medical director of the Cleveland Clinic’s Center for Pathology Informatics and vice chair of the CAP’s Diagnostic Intelligence and Health Information Technology Committee.

“We have to accept that EHR issues as they relate to laboratory data are part of running the lab,” he says. “Laboratories need to allocate resources to this activity. Someone has to pay attention to the orders coming in and how the results are displayed. That’s the bread-and-butter stuff.

“This should be part of lab management, like a quality management plan, or an accreditation plan, is,” Dr. Henricks adds. “It’s an important role in patient care, just as validating a new assay or validating a new instrument is.”
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Kevin B. O’Reilly is CAP TODAY senior editor.