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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Incident serves as a reminder that all clinical laboratories can be just one mistake away from reporting erroneous results to a number of doctors and patients

In May, more than 400 patients who agreed to take the Galleri multi-cancer early detection (MCED) blood test from GRAIL—a California-based biotechnology company that is owned by genetic technology developer Illumina—received letters falsely suggesting they had cancer, according to the Financial Times which broke the news.

The Times reported that a software error had caused GRAIL’s telemedicine provider PWNHealth, which is owned by Everly Health Solutions, to send an erroneous letter to 408 patients misinforming them that “they had a signal in their blood suggesting they could have cancer.”

In a statement, GRAIL said the letters were “in no way related to or caused by an incorrect Galleri laboratory test result” and that “the letters were inadvertently triggered by a PWNHealth software configuration issue, which had now been disabled,” Financial Times reported.

GRAIL, which stated that more than half of the people who received the letters hadn’t even had blood drawn for the test, also added that “no patient health information has been disclosed or breached due to this issue, and no patient harm or adverse events have been reported,” the Financial Times noted.

Nevertheless, it’s not hard to imagine the effect the letters had on those people. No clinical laboratory wants national headlines as a consequence of an error that causes incorrect test results to be reported to doctors and patients. How to prevent such occurrences is a challenge to all clinical laboratory managers.

According to GRAIL, its Galleri multicancer early detection test “can detect a signal shared by more than 50 cancer types and predict the tissue type or organ associated with the signal. At least 45 of these cancers lack recommended screening tests in the US today.” Clinical laboratories that draw the blood sample for the genetic test ship the collection kit directly to GRAIL’s 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 the letters were issued from May 10-18, and on May 19 PWNHealth informed GRAIL of the problem. “We addressed the underlying problem within an hour of becoming aware of it and have implemented additional processes to ensure it does not happen again,” PWNHealth said. “In partnership with GRAIL, we started contacting impacted individuals within 36 hours.”

The software configuration fault was deactivated by PWNHealth, and GRAIL notified affected individuals via phone, email, and regular mail until all had been informed of the error, GRAIL said.

Though GRAIL reacted quickly, there has been fallout caused by the letters. Insurer confidence may have been damaged.

According to 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 unnamed 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 types of cancer with 99.5% specificity and predict the cancer signal origin with high accuracy to help guide next steps,” according to the company’s website.

The $949 test can only be obtained by a doctor’s prescription. At this time it is not covered by insurance, Healthnews reported.

According to a GRAIL Galleri fact sheet, “All cells—cancer and healthy ones—shed DNA, which is called cell-free DNA (cfDNA), into the bloodstream. … After a blood sample is taken at a healthcare provider’s office or at 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 tissue type or organ where the cancer signal originated.

“If a cancer signal is detected, a healthcare provider will determine next steps for diagnostic evaluation, which may include personal and family health history, physical examination, and guideline directed evaluation(s) including lab work and imaging.”

Flashback to Another Notable Lab Error

This is not the first time inaccurate genetic test results have been sent out to patients.

In 2017, Dark Daily’s sister publication, The Dark Report, covered how genetic test developer Invitae Corporation had reported inaccurate genetic test results for up to 50,000 patients over a period of 11 months from September 2016 to July 2017.

In “Invitae Genetics Lab to Retest 50,000 Patients after Finding Errors,” The Dark Report noted that Invitae had failed to test for a specific rare mutation for hereditary cancer, and had to contact and retest many patients.

In a statement, Invitae said the error occurred “because of the unique characteristics of how we we’re testing for the MSH2 Boland inversion, our quality control checks did not catch omission of the components of the assay. … As soon as the omission was recognized and relevant components returned to the assay, it once again performed properly. We have added two separate quality controls to ensure this issue will not reoccur.”

Negative Online Reviews Hurt Businesses including Clinical Laboratories

Negative information about a business can impact its overall success, especially if it is online, digital risk advisory company, Status Labs, notes in “The Real Impact of Negative News on Your Business.”

In its article, Status Labs references a 2021 PEW Research survey which found that “More than eight-in-10 US adults (86%) say they get news from a smartphone, computer, or tablet ‘often’ or ‘sometimes,’ including 60% who say they do so often. This is higher than the portion who get news from television, though 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%) saying the same of print (10% get news from print publications often).”

Status Labs also cited studies showing the impact of negative press online. One study by Trustpilot showed that 90% of consumers said they will not frequent a business that has a bad reputation.

Another study by the University of Pennsylvania found that “negative reviews, messages, or rumors hurt product evaluations and reduce purchase likelihood and sales.”

Vigilance Is the Key

Clinical laboratory leaders are keenly aware that a lab’s reputation can make or break its business. This incident involving GRAIL and its telemedicine provider PWNHealth is a reminder that vendors providing services to medical laboratories can be a source of problems ranging from breaches of protected health information (PHI) to misstatements or misreporting of clinical laboratory test results.

Thus, it behooves lab managers to constantly monitor information leaving the lab, and to ensure all test results sent to patients and doctors are valid and accurate.

—Kristin Althea O’Connor

Related Information:

More than 400 GRAIL Patients Incorrectly Told They May Have Cancer

Company Erroneously Told Hundreds They Might Have Cancer

400 GRAIL Blood Test Users Were Incorrectly Told They May Have Cancer

Health Firm Wrongly Told Hundreds of People They May Have Cancer

The Real Impact of Negative News on Your Business

Invitae Genetics Lab to Retest 50,000 Patients after Finding Errors

GRAIL Galleri Fact Sheet