NEW YORK (GenomeWeb) – Researchers based at Seattle Children's Hospital and the University of Washington have found that a laboratory utilization management program prevents genetic testing order errors, especially those made by clinicians without specialty training, from becoming reaching the patients and becoming diagnostic errors.
The study, published this month in the American Journal of Clinical Pathology, was a follow-up on work that the researchers published in 2014 that emphasized cost minimization for genetic testing with general utilization management (UM), Jane Dickerson, corresponding author and a clinical assistant professor of laboratory medicine at the University of Washington, told GenomeWeb. Dickerson is also an associate director of Reference Lab Services at Seattle Children's Hospital.
The genetic testing market is expanding rapidly. Since new tests are constantly coming on the market and the order systems aren't necessarily easy to navigate, errors can happen. But genetic tests "are relatively high cost and they have a lot of really important diagnostic implications" so it's important to try and catch order errors, said Patrick Mathias, assistant professor of laboratory medicine and associate director of informatics at UW, and first author on the new paper.
The laboratory UM program at Seattle Children's was established in 2012. It required that orders fulfilling certain criteria be reviewed by doctoral-level faculty or genetic counselors before sending out patient samples for testing. According to the paper these criteria include "orders with costs to the laboratory above a certain cost threshold, multiple genetic tests on a single order, orders requested to be sent out to a nonpreferred laboratory, orders requested to be sent out for tests performed in-house, orders requested to be sent out to an international laboratory, and orders for tests predefined as requiring review because they are known to be associated with errors or other problems during the order process."
All information about genetic test orders slated for review were stored in the laboratory UM program's system. This allowed Dickerson, Mathias, and their colleagues to do a retrospective study of order errors as determined by Seattle Children's laboratory UM across nearly 1,400 genetic test orders over a 30-month period between September 2012 and February 2015, in order to have more quantitative information about where the errors come from.
The biggest thing the researchers found was that about five percent of orders from non-geneticists that were slated for review had some kind of error, Mathias said. "The impact [of the error] is quite variable, but [the rate is] still pretty high," he added.
They also noted that the error rate was high when a test was recommended by a geneticist, but ordered by a non-geneticist, Mathias said. Additionally, the team observed that the inpatient order error rate (seven percent of total inpatient orders) was three times the rate observed in outpatient orders.
Most importantly though, the researchers were able to confirm that one-fourth of the orders with errors — approximately one percent of all genetic test orders — could have had diagnostic implications for the patient if the order was not corrected. Diagnostic errors are estimated to affect approximately 12 million outpatient care visits annually in the US, the researchers state in the paper. Limiting those mistakes is important for better patient outcomes.
In the previous publication they were able to show that the program lowered the cost of testing for patients through this review process. Cost saving measures have been particularly important in the laboratory in a post-Affordable Care Act medical world.
However, in the most recent publication Dickerson said that she and her colleagues were also able to emphasize the program's "value in a clinical realm" as a tool for increasing the accuracy of diagnostics.
The researchers did point out that while this study is exciting, it represents a very specialized pediatric setting that doesn't necessarily encompass the medical community at large.
Dickerson, who is also a co-founder of an organization called Pediatric Laboratory Utilization Guidance Services (PLUGS), has been working on taking what the researchers have learned through the laboratory UM program at Seattle Children's and translating that for different types of medical settings. "Even though the P [in PLUGS] stands for pediatrics, the group works with groups in mixed health care systems," she explained.
"We've been talking to other institutions about how we can collaborate and share data on this," added Mathias. "Although normalizing it is a little bit of a challenge."
Many hospitals and medical centers are interested in implementing a UM program, Dickerson said, and quite a few have already done so, including UW's Medical Center and the Cleveland Clinic. She added that there is lots of evidence of the need for this type of system in every patient population.