Researchers note that many sources of errors associated with diagnostic testing involve how providers order tests and how specimens are handled
ECRI (Emergency Care Research Institute), a non-profit organization that focuses on healthcare quality and patient safety, has released results from a study which lays blame for most diagnostic errors on systemic issues that arise during clinical laboratory, radiology, and other diagnostic testing processes. These issues relate to “ordering, collecting, processing, obtaining results, or communicating results,” the organization stated in a news release.
“It’s a common misconception that if a patient has a missed or incorrect diagnosis, their doctor came up with the wrong hypothesis after having all the facts,” said ECRI President and CEO Marcus Schabacker MD, PhD, in the news release. “That does happen occasionally, but we found that was tied to less than 3% of diagnostic errors. What’s more likely to break the diagnostic process are technical, administrative, and communication-related issues. These represent system failures, where many small mistakes lead to one big mistake.”
The researchers based their analysis on reports of adverse patient safety events and “near-misses” submitted to ECRI and the Institute for Safe Medication Practices (ISMP) in 2023. Healthcare providers submitted the data from across the US, ECRI noted.
From a total of 3,014 patient safety events, ECRI determined that 1,011 were related to diagnostic errors. Then, it sorted the events based on “the appropriate step in the diagnostic process where the breakdown occurred,” according to the news release.
ECRI did not reveal how many errors were related to clinical laboratory testing as opposed to radiological or ultrasound imaging.
“The problem of diagnostic safety comes down to the lack of a systems-based approach,” said ECRI President and CEO Marcus Schabacker MD, PhD (above), in a news release. “Since there are multiple potential failure points, a single intervention is insufficient.” Diagnostic errors can also include imaging/radiology and other types of diagnostic procedures—not just clinical laboratory tests. (Photo copyright: ECRI.)
Where Errors Occur
According to ECRI’s analysis, the largest number of errors by far (nearly 70%) happened during the clinical laboratory testing process. Among these, “more than 23% were a result of a technical or processing error, like the misuse of testing equipment, a poorly processed specimen, or a clinician lacking the proper skill to conduct the test,” ECRI stated. “Another 20% of testing errors were a result of mixed-up samples, mislabeled specimens, and tests performed on the wrong patient.”
Outside the testing process, other errors occurred during monitoring and follow-up (12%) and during referral and consultation (9%).
One major factor behind diagnostic errors, ECRI noted, was miscommunication among providers and between providers and patients.
The organization also cited “productivity pressures that prevent providers from exploring all investigative options or from consulting other providers” as leading to diagnostic errors.
In some cases, providers who ordered lab tests delayed reviewing the results or the patients were not notified of the results.
“Referrals to specialists or requests for additional consultations can complicate the process, presenting more potential failure points,” ECRI noted.
Troubling Imaging Anecdotes, Previous Studies
The ECRI news release cites two de-identified patient stories, both related to imaging. One case involved a woman who “experienced abdominal pain and abnormal vaginal bleeding,” but a diagnosis of uterine cancer was delayed nearly a year. “MRIs were ordered, but not all the results were reviewed, as her symptoms worsened. Despite masses being detected on an ultrasound, a missed appointment and communication barriers delayed her diagnosis. She was finally diagnosed after severe pain led to hospitalization.”
In one “near-miss” incident, a patient did not receive an essential carotid ultrasound procedure prior to being scheduled for open-heart surgery. Staff caught the omission and canceled the surgery. A later ultrasound “revealed he would have had a catastrophic surgical outcome if the surgery had proceeded as scheduled,” ECRI stated.
Two earlier studies noted in the news release highlight the impact of diagnostic errors.
A 2017 study, published in the journal BMJ Quality Safety, estimated that diagnostic errors affect approximately 5% of US adults—a total of 12 million—each year. In that paper, the authors combined estimates from three observational studies that defined diagnostic error in similar ways.
“Based upon previous work, we estimate that about half of these errors could potentially be harmful,” the authors wrote.
And a 2024 study published in the same journal estimated that 795,000 Americans die or become permanently disabled each year due to misdiagnosis of dangerous diseases. “Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined,” the authors wrote.
Recommendations for Providers, Labs
ECRI advised that healthcare providers should adopt a “total systems safety approach and human-factors engineering” to reduce diagnostic errors. This is good advice for clinical laboratories as well.
Specific steps should include “integrating EHR workflows, optimizing testing processes, tracking results, and establishing multidisciplinary diagnostic management teams to analyze safety events,” the news release states.
Schabacker also advised patients to “ask questions to understand why their doctor is ordering tests, and are those tests urgent,” he said. “Schedule your appointments and tests quickly and follow up with your provider if you’re awaiting results. If possible, ask a family member or friend to join you in important appointments, to help ask questions and take notes.”
Clinical laboratory managers have been alerted to the involvement of lab testing in incidents of medical errors. This report by ECRI is more evidence of the gaps in care delivery that often contribute to medical error. Medical lab professionals may want to review the ECRI report to learn more about what the authors identify as the specific breakdowns in care processes that contribute to medical errors.
Group’s report also suggests that at-home clinical laboratory tests for COVID-19 that are difficult to use may lead to inaccurate results
At-home clinical laboratory tests for COVID-19 have become quite popular. But how accurate are they? Now, an independent safety organization has investigated COVID-19 rapid antigen tests to find out how easy—or not—they are to use and what that means for the accuracy of the tests’ results.
ECRI (Emergency Care Research Institute) of Plymouth Meeting, Penn., “conducted a usability evaluation to determine if there were any differences in ease of use for the rapid COVID-19 tests,” according to the company’s website.The nonprofit was founded in the 1960s by surgeon and inventor Joel J. Nobel to evaluate medical devices that have been approved by the U.S. Food and Drug Administration (FDA).
“Because of the urgency in providing useful information to consumers as quickly as possible, ECRI selected the seven test kits based on retail availability,” ECRI noted.
ECRI ranked the seven over-the-counter (OTC) at-home rapid antigen tests according to their SUS usability ratings. The System Usability Scale (SUS), invented by John Brooke in 1986, “rates products on a scale of 0 to 100 with 100 being the easiest to use. More than 30 points separated the top and bottom tests analyzed,” according to Managed Healthcare Executive.
Of the seven rapid antigen test kits for COVID-19, ECRI found “noteworthy usability concerns” and “significant differences in ease of use.” None of the tests achieved a SUS rating of “excellent,” ECRI stated in a press release.
“Our evaluation shows that some rapid [COVID-19] tests are much easier to use than others. If given options, consumers should choose tests that are the easiest to use because when a [COVID-19] test is difficult for a consumer to use, it may lead to an inaccurate result,” said ECRI President and CEO Marcus Schabacker, MD, PhD, in a news release. Marcus “is a board-certified anesthesiologist and intensive care specialist with more than 35 years of healthcare experience in complex global environments, and more than 20 years of senior leadership responsibilities serving the medical device and pharmaceutical industries across the healthcare value chain,” states ECRI. (Photo copyright: Biz Journals.)
Seven Rapid Antigen Tests for SARS-CoV-2 Evaluated
As clinical laboratory scientists and pathologists know, it’s possible for different test methodologies for the same biomarker to produce dissimilar results. Another factor affecting medical laboratory test accuracy is the variability from one manufacturing batch or lot to another. And, as the ECRI report suggests, how a specimen is collected and handled can affect accuracy, reliability, and reproducibility of the test results generated by that specimen.
These are the OTC COVID-19 rapid antigen tests ECRI evaluated and their SUS ratings:
Some tests, the ECRI analysts found, required “fine motor control” or were packed with written instructions ECRI determined were too small for older adults to read.
How ECRI Evaluated the COVID-19 Rapid Antigen Tests
SUS reviewers took each rapid test and completed questionnaires specifying their level of agreement (on a range of one to five) with these statements. (Edited by Dark Daily for space):
Desire to use
Perception of unnecessary complexity
Easy to use
Support of a technical person needed
Functions well-integrated
Too much system inconsistency
Easy to learn for most people
A very cumbersome system to use
Feeling of confidence in use
A need to learn before getting going
ECRI then used an algorithm to derive an aggregate score (from 0 to 100) for each test, the report noted.
“Based on the aggregate SUS scores, none of the COVID-19 test kits would be judged to have ‘excellent’ usability. The On/Go, CareStart, Flowflex test kits we rate as ‘very good’ as the usability score for these kits falls just short of ‘excellent,’” the report said.
Some of the positive responses ECRI received from the SUS participants included:
“One of the simpler tests to use with good, printed instructions,” (On/Go and CareStart).
“Cassette makes handling without touching test strip easy,” (CareStart and Flowflex).
“The QR (quick-response) code-linked instructional video is helpful, but probably not needed,” (QuickVue).
“Once the swab is inserted into the test card, the test seems less likely to be spilled or disturbed than other test kits,” (BinaxNOW).
Is it Time for Rapid COVID-19 Antigen Tests?
Unlike RT-PCR tests that can take hours or days to return results, rapid antigen tests provide a quick result that’s used for screening worldwide. And with the COVID-19 Omicron variant spreading rapidly around the world, speed is much needed, according to Stephen Kissler, PhD, Research Fellow in the department of immunology and infectious diseases at Harvard’s T.H. Chan School of Public Health.
“I think the rapid tests provide some of the best protection we have against the spread of disease, especially as we now have a variant on hand that’s going to be able to cause an awful lot of breakthrough infections,” Kissler told The Atlantic-Journal Constitution.
One way clinical laboratory leaders can help is to reach out in their local markets and provide information on the importance of appropriate sampling and collection for accurate results from rapid COVID-19 antigen testing.
Clinical laboratories can play a role in two of these ten cost-cutting opportunities
Everyone in healthcare expects significant across-the-board cuts to reimbursement as healthcare reform moves forward. High profile targets for cost-cutting are imaging technologies and physician preference items (PPIs), which include expensive supplies and implant products, including stents, wires, pacemakers, and knee/hip replacement prosthetics.
Hospitals and health systems, in recognition of this major shift in national health policy, are scrambling to stay ahead of these economic and regulatory pressures. It is causing them to closely scrutinize operational costs and implement cost-cutting measures.
