January 2015—While no one would question the virtues of accurate laboratory results, a recently concluded Q-Probes study is a new reminder that alone they’re not enough.
Results should be reviewed before a lab goes live with a new interface that transmits results to the electronic health record, as well as when changes are made at the laboratory or EHR level that could alter test resulting. They also should be reviewed periodically, say the authors of the study, titled “Validating Laboratory Results in Electronic Health Records.”
That’s because accurate test results that are transmitted from an LIS to an EHR may do little good if, in the process, they lose crucial informational components or undergo puzzling format changes.
“I deal with this all the time in our own organization,” says study coauthor Donald Karcher, MD, professor and chair of pathology and director of laboratories at George Washington University Medical Center, Washington, DC. “We set up a new test and have to format it, and it looks great in the LIS, but then it crosses an interface and the formatting is all garbled, and we have to work with the IT department so they can reformat the results to make them more easily readable.”
How many laboratories take the time to examine the formatting of test results that have been transmitted to the EHR, and to work with IT staff to remedy problems, if any? And how often are these results distorted or made incomplete in the transmission process? That’s what the CAP study sought to determine.
Forty-five institutions enrolled in the study, which required the participation of laboratory supervisors and information technology staff. The participants retrospectively reviewed 1,064 normal and abnormal results of 16 individual laboratory tests by directly viewing results within the EHR. The study excluded preliminary, nonverified, and working results as well as results from point-of-care tests. Results included were inpatient and outpatient, in-house and send-out, manually entered and electronically transmitted, numeric and text, manually or automatically resulted, and within and outside reference ranges, including critical values. Anatomic pathology results were included if they were reported in the EHR.
“The reason we decided to do the study,” explains Dr. Karcher, a member of the CAP Quality Practices Committee, “was that the number of institutions that have gone totally to electronic records has risen. Many health care organizations are totally paperless now. The only time anything gets printed here,” he says, referring to George Washington, “is if a patient needs to bring pathology slides and a printed report to another institution for a second opinion. Aside from that, we generate zero paper, and we’re not atypical at all.”
Of the results the study looked at, 99 percent were found to have been accurately transmitted from the LIS to the EHR—an expected finding given that the majority of results are entered electronically. But those accurate results were transmitted completely only 70 percent of the time. That is, nearly a third of them, once transmitted to the EHR, were missing one or more items, most commonly the name and address of the performing laboratory and the date and time of the test result or report.
Institutions in which less than half of test orders were entered electronically had lower test result completeness rates. “This may be due to less developed electronic interfaces at these institutions,” the authors write in their analysis of the data.[hr]
Tests reviewed during the study
- Hemoglobin A1c
- Blood culture with sensitivity results
- Serum protein electrophoresis
- Blood bank antibody screen
- HIV-1 quantitative PCR assay
- Corrected platelet count
- Factor V Leiden mutational assay (PCR)
- AP routine surgical result with synoptic reporting
- EBV VCA IgG antibody, serum
- Breast pathology result with estrogen receptor studies
- Pap cytology report with HPV testing
- Second trimester maternal screen (quad)
- Heparin-dependent antibody
Only 91 percent of the test results examined in the study were formatted appropriately—that is, they were configured correctly in EHR screen views and EHR paper printouts and devoid of irrelevant or incorrect information. The chief problem participants found was that the results contained extraneous information on the EHR computer screen that should not have been reported and could impair the usability of the test data, the authors say.
Dr. Karcher explains: “Health information can be transmitted accurately and completely on a computer screen, but with the data not lined up properly. Maybe you have to look in the lower left corner to find what you’re really looking for, or maybe there’s garbled stuff. And that would technically qualify as an acceptable report for accreditation purposes, but it’s totally unacceptable in terms of the clinician. Information can be on the screen, but if the clinician doesn’t notice it or doesn’t realize it’s abnormal, bad things can happen.”
Tests that are more complex or performed in a reference laboratory are more likely to have problems such as missing elements or garbled formatting, says study coauthor and Quality Practices Committee member Peter L. Perrotta, MD, medical director of clinical laboratories at West Virginia University Hospital and professor of pathology at West Virginia University School of Medicine, Morgantown. “With some of the simpler tests, like sodiums or potassiums—tests that are performed in an individual laboratory and sent directly to the EHR—you’re usually not going to see many problems,” he says. “With more complex testing or reference laboratory testing, you may end up missing some of the required elements or may have formatting problems that make the results difficult to understand.” (The results examined in the study were from tests of varying degrees of complexity. See box, page 42.)
Finally, the study found that only 79.5 percent of laboratory directors review results on their institution’s EHR at the time of its implementation to expose potential problem areas such as those found in the study. Further, only 61.4 percent of directors perform such a review at least every two years, and 6.8 percent never perform these reviews.
“It should be 100 percent” of directors who review results on an EHR when it’s implemented, Dr. Karcher says.
In the Q-Probes analysis, he and his coauthors write: “In this study, a relatively low percentage of laboratories verify the transmission of data to the EHR at least once a year or every other year. The CAP Laboratory General Checklist (GEN.41067) requires that the CAP laboratory director review and approve the content and format of paper and electronic patient reports at least every two years.”
Eighteen percent of laboratories reported receiving more than three documented complaints monthly about the format of test results in the EHR. Seventy-seven percent said they rarely receive complaints (fewer than one per month); 4.5 percent said they do so “somewhat often” (one to three monthly).
Ideally, Dr. Perrotta says, laboratory directors should involve themselves in the very design of the laboratory test resulting modules in their EHRs. “The biggest problems seem to occur when the laboratory is not involved in that project,” he says. “Many institutions have gone to more centralized information technology services and may have pulled back on their specialized laboratory IT resources. Sometimes some of these things get lost when you don’t have dedicated laboratory IT personnel.”
Whether the Q-Probes study’s readers have the benefit of dedicated lab IT personnel or not, “We hope this study sensitizes them to the importance of doing appropriate validation,” Dr. Karcher says. He feels so strongly about the subject that, as president of the Association of Pathology Chairs, he has worked with the CAP and with the Association for Pathology Informatics to design a pathology informatics curriculum for pathology residents, “and one of the very important parts of this curriculum is pointing out the importance of ensuring proper electronic transmission of results,” he says. “This is a very, very important role of the laboratory director.”
Anne Ford is a writer in Evanston, Ill.