The incident serves as a reminder that all clinical laboratories can be one mistake away from reporting erroneous results to a number of doctors and patients
In May, more than 400 patients who agreed to have the Galleri Early Multi-Cancer Detection (MCED) blood test by GRAIL, a California-based biotechnology company owned by gene technology developer Illumina, received letters falsely suggesting he has cancer, according to the Financial Times who broke the news.
Times reported that a software glitch had caused GRAIL telehealth provider PWNHealth, owned by Everly Health Solutions, to send an incorrect letter to 408 patients incorrectly informing them that they had a signal in their blood suggesting they might have cancer.
In a statement, GRAIL said the letters were in no way related to or caused by an erroneous Galleri lab test result, and that the letters were inadvertently triggered by a configuration problem with the PWNHealth software, which had now been disabled. Financial Times reported.
GRAIL, which said that more than half of the people who received the letters had not even had blood drawn for testing, also added that no patient health information has been disclosed or breached as a result of this issue, and no patient harm or adverse events were reported. reported, the Financial Times noticed.
However, it is not difficult to imagine the effect the letters had on these people. No clinical laboratory wants national titles as a result of an error that causes doctors and patients to report incorrect test results. How to prevent such events is a challenge for all clinical laboratory managers.
According to GRAIL, its Galleri early multitumor detection test can detect a signal shared by more than 50 cancer types and predict the tissue or organ type associated with the signal. At least 45 of these cancers do not have screening tests recommended in the United States today. The clinical laboratories that collect the blood sample for genetic testing ship the collection kit directly to the GRAIL laboratory for processing. (Photo copyright: GRAIL.)
What went wrong
PWNHealth said in a statement that the letters were sent due to a misconfiguration of our patient engagement platform used to send templated communications to individuals, CBS News reported.
Financial Times reported that letters were issued May 10-18, and on May 19, PWNHealth notified GRAIL of the issue. We addressed the underlying issue within an hour of becoming aware of it and have implemented additional processes to ensure it doesn’t happen again, PWNHealth said. In cooperation with GRAIL, we started contacting interested people within 36 hours.
The software misconfiguration was taken down by PWNHealth and GRAIL notified affected individuals by phone, email and snail mail until everyone was notified of the error, GRAIL said.
Although GRAIL reacted quickly, there were negative consequences caused by the letters. The trust of the insurer may have been damaged.
Second Financial Times, customers of life insurance company MassMutual and another unnamed insurer had been affected by the erroneous letters. As a result, MassMutual had suspended a pilot program and the anonymous insurer was reviewing its relationship with GRAIL.
About GRAIL and the Galleri liquid biopsy test
GRAIL was founded in 2015 in San Francisco, California with the goal of detecting early stage cancer. They developed the Galleri liquid biopsy test which requires only one blood sample and can detect a signal shared by over 50 cancer types with 99.5% specificity and predict the origin of the cancer signal with high accuracy to help guide the next steps, according to the company’s website.
The $949 test can only be obtained with a prescription. It is currently not covered by insurance, Health news reported.
According to a fact sheet from GRAIL Galleri, all cancer cells and healthy cells release DNA, called cell-free DNA (cfDNA), into the bloodstream. After a blood sample has been drawn at a healthcare providers office or a GRAIL partner laboratory, the Galleri test uses the power of next-generation sequencing and machine learning algorithms to analyze cfDNA methylation patterns.
The test uses these methylation patterns to determine if a cancer signal is present and, if so, predict the type of tissue or organ in which the cancer signal originated.
If a sign of cancer is found, a healthcare professional will determine the next steps for the diagnostic evaluation, which may include personal and family history, physical exam, and guideline-directed evaluation(s), including lab work and imaging.
Flashback to another notable lab error
This isn’t the first time inaccurate genetic test results have been sent to patients.
In 2017, Dark newspapers sister publication, The Dark Relationshipexplained how genetic testing developer Invitae Corporation reported inaccurate genetic test results for up to 50,000 patients over an 11-month period from September 2016 to July 2017.
In Invitae Genetics Lab to retest 50,000 patients after finding errors, The Dark Relationship noted that Invitae had failed to test a rare mutation specific to hereditary cancer and had to contact and retest many patients.
In a statement, Invitae said the error occurred due to the unique characteristics of how we were testing the Boland MSH2 inversion, our QC checks did not detect the omission of the test components. As soon as the omission was acknowledged and the relevant components were returned to testing, it worked correctly once again. We have added two separate quality checks to ensure this issue does not reoccur.
Negative online reviews hurt companies, including clinical laboratories
Negative information about a business can affect its overall success, especially if it’s online, digital risk consultancy Status Labs notes in The Real Impact of Negative News on Your Business.
In its article, Status Labs references a 2021 PEW Research survey that found that more than eight in 10 (86%) U.S. adults say they get news from a smartphone, computer or tablet often or sometimes, including 60 % who says they do it often. This is higher than the portion that gets news from television, although 68% get news from TV at least sometimes and 40% do so often. Americans turn to radio and print publications for news far less frequently, with half saying they turn to radio at least sometimes (16% do so often), and about a third (32%) say the same about print (10% receive news from the press often publications).
Status Labs also cited studies showing the impact of online negative press. A Trustpilot study showed that 90% of consumers said they won’t frequent a business with a bad reputation.
Another study from the University of Pennsylvania found that negative reviews, messages or rumors hurt product ratings and reduce purchase likelihood and sales.
Vigilance is the key
Clinical laboratory leaders are acutely aware that a laboratory’s reputation can make or break its business. This incident involving GRAIL and its telehealth provider PWNHealth is a reminder that providers who provide services to medical laboratories can be a source of problems ranging from protected health information (PHI) breaches to misrepresentations or miscommunication of clinical laboratory test results.
Therefore, it is necessary for laboratory managers to constantly monitor the information leaving the laboratory and to ensure that all test results sent to patients and physicians are valid and accurate.
Kristin Althea O’Connor
Related information:
More than 400 GRAIL patients have been incorrectly told they may have cancer
The company has wrongly told hundreds of people they might have cancer
400 GRAIL blood test users were wrongly told they may have cancer
The health care company has wrongly told hundreds of people they might have cancer
The true impact of negative news on your business
It invites Genetics Lab to repeat the test on 50,000 patients after finding errors
GRAAL Galleri card
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