Telemedicine Provider for GRAIL Genetic Testing Laboratory Wrongly Alerts More than 400 Patients They May Have Cancer

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

UCSB Researchers Discover Superior Culture Medium for Bacterial Testing, along with New Insights into Antimicrobial Resistance

Study may also result in new clinical laboratory tools for determining antimicrobial resistance and efficacy of existing antibiotics

Researchers find it increasingly difficult to develop antibiotics that are effective against strains of bacteria that display antibiotic resistance—a subset of antimicrobial resistance (AMR). However, a new study provides a glimmer of hope and may spur clinical laboratories to look at this research in novel ways.

Conducted at the University of California Santa Barbara, the study looked at more than 500 antibiotic-bacteria combinations. The researchers discovered that several widely used, FDA-approved, antibiotics may be more useful than previously thought against a large range of bacterial infections, said infectious disease specialist Judy Stone, MD, in an article she penned for Forbes titled, “Why Antibiotics Fail—and How We Can Do Better.”

The researchers also discovered a common culture medium that enables a better assessment of the properties of various strains of bacteria to resist different antibiotics.

Clinical laboratories and microbiologists are tasked with plating and growing bugs to identify a specific bug, what strain of bug, and whether that strain has resistance to specific antibiotics. Thus, this research touches on what they do daily. It is something that may provide microbiologists with new approaches to detect AMR more accurately.

“We know there are a variety of reasons why antibiotics don’t work as predicted, from wrongly prescribed doses to infrequent administration, but another less noticeable reason is that lab testing can show a bacteria is susceptible to antibiotics when it’s actually not. You know, the whole in vitro (culture plate) versus in vivo (life) balance,” wrote Judy Stone, MD, infectious disease expert, in her Forbes article. Clinical laboratories may soon have a better way of identifying antibiotic resistance in deadly bacteria. (Photo: LinkedIn profile.)

UCSB Antimicrobial Study Details

Antibiotic-resistant infections are responsible for more than 32,000 deaths in the US and 1.27 million globally every year, Forbes reported. A study like this can have a far-reaching impact.

To conduct their study, Michael Mahan, PhD, Professor of Molecular, Cellular, and Developmental Biology at UCSB, and his team at the Mahan Lab on the UCSB campus, used Fisher Scientific’s Gibco Dulbecco’s Modified Eagle Medium (DMEM), a basal medium for supporting the growth of many different mammalian cells.

The DMEM predicted antibiotic effectiveness better than Mueller Hinton Broth (MHB), another growth medium from Thermo Fisher Scientific that has been used in clinical laboratories by World Health Organization (WHO) decree since 1968, Forbes reported.

Assays were run against 13 isolates from nine species of bacteria to determine the efficacy of 15 different antibiotics. Using DMEM, the team found different sensitivities in 15% of the bacterial isolates tested in vitro compared to MHB.

In Mahan’s follow-up tests, which looked at mice infected with different bacteria, MHB was accurate in 54% of test predictions while DMEM was accurate 77% of the time. Part of the reason, Mahan believes, is because DMEM is more physiologic and closer in conditions to people (in vivo), Forbes reported.

“People are not Petri plates—that is why antibiotics fail. Testing under conditions that mimic the body improves the accuracy by which lab tests predict drug potency,” said Mahan in a UCSB press release.

The Mahan Lab researchers published their findings in the journal Cell Reports Medicine, titled, “Re-evaluation of FDA-Approved Antibiotics with Increased Diagnostic Accuracy for Assessment of Antimicrobial Resistance.”

Results Look Promising

“I think it has merit. I think this study has been very well-designed … and showed that this makes clinical sense … If it bears out in humans, it will be clinically very significant,” pulmonologist Ken Yomer Yoneda, MD, Professor Emeritus, Department of Internal Medicine at UC Davis Health, told Forbes.

Though the major limitation of the study is that it was conducted on mice and not humans, Yoneda said it gives an indication of potential success with humans. “If it bears out in humans it will be clinically very significant,” he told Stone for her Forbes article.

Rodney Rohde, PhD, Professor and Chair of Clinical Lab Science Program at Texas State University also shared enthusiasm on the findings. According to Stone, “[Rohde] was ‘intrigued’ by the finding that using a physiologic media predicted ‘a change in susceptibility’ thresholds used to categorize patient isolates as susceptible or resistant.

“He was also ‘excited about the results of increasing diagnostic accuracy’ with especially difficult-to-treat organisms,” she noted.

“Rohde added that the issue of these clinical breakpoints—setting the level at which an organism is defined as ‘sensitive’ or ‘resistant’ to an antibiotic is a hot topic, undergoing considerable discussion in lab circles. Multiple agencies need to reach agreement for the standards that are used globally, both in the US and Europe,” Stone wrote.

Old Drug, New Tricks

According to the UCSB press release, “Physicians are aware of the flaws in the gold-standard test [MHB]. When recommended antibiotics do not work, they must rely on their experience to decide on the appropriate antibiotic(s) for their patients. This study provides a potential solution to address the disparity between antibiotics indicated by standard testing and actual patient outcomes.” 

Infectious disease physician Lynn Fitzgibbons, MD, remarked in the UCSB press release, “Re-evaluation of FDA-approved antibiotics may be of far greater benefit than the time and cost of developing new drugs to combat antimicrobial resistance, potentially leading to significant life-savings and cost-savings.”

In her Forbes article, Stone wrote, “Pharmaceutical companies are abandoning the acute infectious disease market and few new antibiotics are in sight. Pharma is profit driven and antibiotics are simply not as lucrative as life-style drugs (like Viagra/Cialis or Rogaine for hair loss) or those for chronic diseases. So, Mahan et al.’s findings are welcome news indeed.”

Once further studies validate the UCSB study findings and allow their use in clinical settings for patient care, clinical laboratories and microbiologists may have new tools for accurately determining a bacterium’s ability to resist existing antibiotics or its susceptibility to antibiotics not currently used to treat certain infections.

—Kristin Althea O’Connor

Related Information:

Why Antibiotics Fail and How We Can Do Better

Re-evaluation of FDA-Approved Antibiotics with Increased Diagnostic Accuracy for Assessment of Antimicrobial Resistance

New Test Reveals Existing Antibiotics, Hiding in Plain Sight on Pharmacy Shelves, Can Cure Superbugs

New $52 Million Biosafety Level 3 Laboratory to Be Constructed in Dallas County, Texas

Level 3 bio labs handle Ebola, smallpox and other deadly diseases, and may play a role in research into the human genome

Because of the COVID-19 pandemic, there is a concerted effort to improve public health laboratories and increase the growth of bioresearch. Clinical laboratories across the country are required by law to send specimens of certain infectious diseases to public health labs for testing and analysis. The results of those tests are then reported to the federal Centers for Disease Control and Prevention (CDC), which is working to foster robust connections and relationships between clinical labs and public health labs.

One such effort was recently announced in Dallas County, Texas. It will create the Dallas County Health and Human Services Public Health Laboratory. The 75,000 square-foot level 3 biological safety lab (BSL-3) will be built from the ground up and customized to meet the requirements and specifications of the county. It will be used to study potentially lethal infectious agents or toxins that can be transmitted through the air and will be located on the north end of the Southwestern Medical District, according to Dallas Innovates.

A land transaction for a 1.6-acre purchase between Dallas County and TXRE Properties closed in April. The development of the lab is expected to cost $52 million and should be completed by late 2025 with occupancy as early as January 2026.

Artist rendering of new health facility

The graphic above is an artist rendering of what the new Dallas County Health and Human Services Public Health Laboratory may look like. For some time now, Dallas County has been working to create a hub centered around infrastructure and buildings to be used for bio development and research, public health labs, and even clinical laboratories. (Graphic copyright: 5G Studio Collaborative.)

Continuing Support for HHS

“The large-scale response required for COVID-19 demonstrated the need for the acquisition that will permit the continued support of the HHS efforts in response to the ongoing safety, containment, incident response to emerging and high consequence diseases that could operate at the peak of a crisis without hindering or being hindered by other county operations,” states a Dallas County Commissioners Court Order, D Magazine reported.

Funding for the project is coming from the Coronavirus State and Local Fiscal Recovery Funds (SLRFR) program—part of the American Rescue Plan—which is designed to help local governments respond to and recover from the COVID-19 public health emergency.

“The county currently utilizes owned facilities to provide laboratory services, testing services, and other initiatives,” according to the court order. “These facilities have performance and design shortcomings and have required significant capital expenditure for their ongoing use.

“To avoid leasing space and avoid additional capital investment into deferred and ongoing maintenance, the county has been searching for a suitable location/acquisition to collocate uses/departments into a centralized, efficient, and suitable laboratory,” the court order continued.

Lab Will Conduct Research into Potentially Fatal Diseases

The facility will pursue becoming a Biological Safety Level-3 laboratory. BSL-3 labs typically conduct research or work on microbes that can cause serious and potentially fatal disease through inhalation. These labs are required to be easily decontaminated. They must also have additional safety measures, including interlocked doors, sealed windows, floors, and walls, and filtered ventilation systems.

“The core diagnostic functions are—along with safety—related to identification, containment, security, and incident response to emerging and high consequence diseases,” the court order notes.

According to the National Institutes of Health (NIH), the actual number of BSL-3 facilities in the US is currently unknown “because federal registration is required only if select agent (National SA Registry) or NIH-funded recombinant DNA (rDNA) (Institutional Biosafety Committee [IBC]) work is conducted,” according to an article published in the journal Biosecurity and Bioterrorism: Biodefense, Strategy, Practice, and Science, titled, “BSL-3 Laboratory Practices in the United States: Comparison of Select Agent and Non–Select Agent Facilities.”

A Georgetown University article published last year concluded there are 148 institutions with BSL-3 laboratories in the US. This number was established by identifying and totaling the number of BSL-3 facilities that published research between 2006 and 2021 using PubMed Central, a full-text archive of biomedical and life sciences journal literature at the US National Institutes of Health’s National Library of Medicine (NIH/NLM).

The creation of this new biosafety lab in Dallas is consistent with the trend of investment dollars being poured into research into the human genome. This type of research, along with the creation of new facilities, can directly lead to new biomarkers that can be utilized in clinical laboratory testing and disease prevention. 

—JP Schlingman

Related Information:

Dallas County Plans $52 Million Bio Lab Development Near Southwestern Medical District

Dallas County to Build New $52M Bio-Lab Facility

Dallas County to Build a $52M Bio Lab and Life Sciences Building Near the Southwestern Medical District

Coronavirus State and Local Fiscal Recovery Funds

Dallas Medical District Property Sells for New Laboratory Project

BSL-3 Laboratory Practices in the United States: Comparison of Select Agent and Non–Select Agent Facilities

Mapping Biosafety Level-3 Laboratories by Publications

What is a BSL-3 (Biological Safety Levels) Lab?

Institutional Biosafety Committee

Biosafety Level Requirements

Innovators Develop Multi-Analyte Pulse Oximeters That Accurately Read Oxygen Levels in People with Darker Skin Pigmentation

Multiple studies have shown that people with darker skin pigmentation run a higher risk of being misdiagnosed and undertreated than patients with lighter skin due to inaccurate oxygen level readings

Though pulse oximeters are not a standard clinical laboratory device, clinical laboratory scientists (aka, medical technologists) know of them and understand their function, particularly with hospital patients.

Now, scientists at multiple institutions are working to improve the basic pulse oximeter’s design by making it capable of measuring multiple biomarkers, as well as addressing long-standing inaccuracies in the device when used on people with darker skin pigmentation.

This ongoing research demonstrates how new technologies are enabling innovators to add useful functions to standard, well-accepted devices.

Valencia Koomson, PhD

Valencia Koomson, PhD (above), Associate Professor, Electrical and Computer Engineering, and head of the Advanced Integrated Circuits and Systems Lab at Tufts University, has developed a pulse oximeter that measures oxygenation in tissue, rather than in blood. Her approach could ensure patients with darker skin pigmentation will be accurately diagnosed at the point-of-care. Though generally not used in clinical laboratory settings, medical technologists will be interested to learn of these new innovations in pulse oximeters. (Photo copyright: Tufts University.)

Measuring Tissues Instead of Blood

The pulse oximeter—a device that attaches to a person’s finger—uses red and infrared light to measure blood oxygen saturation (SpO2) and display pulse rate.

Studies in 2022 that looked into how hospitals administered oxygen to different patients found that inconsistent pulse oximeter readings could cause caregivers to administer less oxygen than is actually needed to people with darker skin pigmentation.

This is because melanin in the skin can interfere with “absorption of light used to measure oxygenated blood in a person’s finger,” according to a National Science Foundation (NSF) news story. Such inaccurate pulse oximeter readings can lead to “inaccurate readings and poorer treatment outcomes” for people with dark skin tones, the NSF wrote.

“Addressing this problem will require innovation in pulse oximeter design and revised regulatory standards,” said Valencia Koomson, PhD, Associate Professor, Electrical and Computer Engineering, Tufts University, Medford, Massachusetts, in the NSF news story.

Koomson, who leads the Advance Integrated Circuit and Systems Lab at Tufts, has developed a prototype pulse oximeter device, which NSF explained, measures oxygenation in biological tissues instead of blood.

NSF supports her pulse oximeter research through the National Science Foundation Partnerships for Innovation (PFI) program.

“My lab’s work on pulse oximeter devices will provide an alternative technology to address many confounding factors that affect pulse oximeter accuracy, including skin pigmentation, motion artifact, and others,” Koomson said.

National Public Radio (NPR) said Koomson’s device has built-in “technology that can measure a person’s skin tone.”

“We can send more light if there’s a higher level of melanin present, so that melanin doesn’t become a confounding factor that obscures our results,” Koomson told NPR.

Another Pulse Oximeter Redesign

Another new approach to pulse oximetry was developed at Brown University in Providence, Rhode Island.

Rutendo Jakachira, Research Assistant, School of Engineering, and a PhD student in physics, turned to new optical techniques to address the challenge of oxygen saturation levels in dark skin tones, according to a Brown University news release.

Jakachira and Kimani Toussaint, PhD, Professor of Engineering and Senior Associate Dean in the School of Engineering, say they have created possibly the first LED-based light source to emit radially polarized light.

When the LED passes light through a person’s finger, the device calculates the amount of light the hemoglobin in the blood absorbed, NPR explained.

“We did a preliminary study on about five people, and although it was a small study, the results are promising,” said Jakachira, who plans a larger study and clinical trial. 

Study Suggests Patients with Darker Skin May Have Received Delayed COVID-19 Care

Meanwhile, a study published in the American Journal of Epidemiology (AJE) suggested pulse oximeter errors may have led to a 4.5-hour delay in COVID-19 treatment of patients with darker skin pigmentation, according to a news release from the University of California San Francisco.

The researchers analyzed electronic health record (EHR) data from 43,753 patients at Sutter Health in Sacramento, California, who had SpO2 measurements done between January 2020 and February 2022, and 8,735 patients seen for COVID-19 between July 2020 and February 2021 in the hospital’s emergency department.

In their AJE paper, they wrote, “We investigated whether or not pulse oximetry systematically underestimated oxygen saturation in patients who identified as NHB [non-Hispanic Black/African-American] as compared with NHW [non-Hispanic White] counterparts. We also assessed whether or not differences in oxygen saturation measurement affected hospital admission, care delivered, or return to the hospital post discharge among patients with COVID-19.

“We found evidence of differential pulse oximeter measurement error in NHB individuals, resulting in nonrandom overestimation of blood oxygenation as compared with NHW individuals. NHB individuals were also more likely to have hypoxemia [abnormally low oxygen levels in the blood] not detected by pulse oximetry.

“For NHB patients presenting in the ED with COVID-19, we found that overestimation of oxygen saturation was associated with underestimation of the need for admission and underestimation of the need for treatment with dexamethasone and supplemental oxygen. Additionally, we observed associated delays in dexamethasone initiation and initiation of oxygen supplementation.

“There are also broader implications beyond COVID-19, as differential pulse oximeter accuracy has the potential to exacerbate disparities for any condition that relies upon blood oxygenation measurement to inform clinical decision-making.”

Importance of Accurate Readings

Developing pulse oximeters that are accurate for all people, regardless of skin tone, is clearly an important breakthrough. Medical laboratory leaders and pathologists recognize that SpO2 data—along with clinical laboratory test results—are critical for successful diagnostics and treatment. Thus, new technologies that add useful functions to well-accepted devices are positive developments and worth watching.    

Donna Marie Pocius

Related Information:

Researcher Addresses Longstanding Problem with Pulse Oximeters and Dark-skinned Patients

When it Comes to Darker Skin, Pulse Oximeters Fall Short

Brown PhD Student Working to Correct Skin Color Bias in Pulse Oximeters

Pulse Oximeters Don’t Work as Well on Darker Skin, Leading to Flawed COVID-19 Care

Racial Disparities in Pulse Oximeter Device Inaccuracy and Estimated Clinical Impact on COVID-19 Treatment Course

City of Baltimore, University of Maryland Create Pilot Program to Train People to Work in Clinical Laboratories

Funded by the CDC, the program hopes to alleviate personnel shortages in Baltimore area clinical labs while also producing a knowledge base for lab managers nationwide

Clinical laboratory managers struggling to fill vacant phlebotomy and accessioning positions will be interested to learn about a pilot program being conducted by the City of Baltimore and the University of Maryland School of Medicine to train people “for employment in hospital laboratories, phlebotomy draw sites, and reference laboratory processing centers,” according to The Elm, a publication of the University of Maryland, Baltimore.

The 14-week “Mayor’s Workforce Development Program” began on April 19 and will continue through the end of July. Participants meet twice a week for lectures and experience working with specimens in actual medical laboratories or in a “hybrid learning environment,” The Elm reported.

“I came up with the idea of doing cross-training for laboratory people and public health people in case there is another pandemic,” explained Lorraine Doucette in an exclusive interview with Dark Daily. Doucette, who is managing the pilot program, is an Assistant Professor and Medical Laboratory Science Program Director, Department of Medical and Research Technology, University of Maryland School of Medicine.

“There is already a huge shortage of laboratory people, but an enormous amount left in droves during the pandemic because they got physically burned out. Some just could not do the work anymore because of things like carpal tunnel syndrome and repetitive stress injuries,” she added.

Lorraine Doucette

“I’m confident that all 15 or 16 students who complete this workforce program will be employed within weeks of finishing as accessioners,” said Lorraine Doucette (above), Assistant Professor and Medical Laboratory Science Program Director, Department of Medical and Research Technology, University of Maryland School of Medicine, in an exclusive interview with Dark Daily. “This has been so successful. This is making a difference in people’s lives. This is changing them from being unemployed to actually having a career in a clinical laboratory. They love it. They are so proud of themselves.” (Photo copyright: LinkedIn.)

CDC Funding Part of National Program to ‘Enhance’ Clinical Lab Workforce

Doucette and her team met with people from the Baltimore Mayor’s Office of Employment Development (MOED) to discuss a possible partnership. They were interested and Doucette eventually became a recipient of funding through a cooperative agreement with the federal Centers for Disease and Control Prevention (CDC).

The collaboration is part of a CDC project titled, “Enhancing US Clinical Workforce Capacity.’ Doucette will receive a total of one million dollars over the course of three years to facilitate the program in stages.

“It is not necessarily an old-fashioned grant where they just gave me a pile of money,” Doucette told Dark Daily. “The CDC works with me constantly via reports and Zoom meetings.”

This CDC project is designed to both cross train clinical laboratory professionals in public health, clinical chemistry, microbiology, and hematology, as well as to train individuals in the workforce development program to become laboratory accessioners.

“They are going to be qualified to work as an accessioner in any local hospital,” Doucette noted. “The people who pick up the lab samples out of the tube system are the accessioners and there is a huge shortage of them also. We’re teaching them the basics so the more advanced lab personnel can perform the higher-level work.”

Students in the program learn all about lab safety and the proper handling of lab samples as well as proper data entry, professionalism, and how to communicate with medical and laboratory personnel. They work with urine and blood samples and fabricated spinal fluid samples. 

“They are taught about the different tubes, what the anticoagulants are, what makes each tube unique, why you can’t mix samples, balancing a centrifuge, and how to properly put on and remove safety gear like lab coats, gloves, and goggles,” Doucette explained. 

The Mayor’s Workforce Development Program is free for Baltimore residents looking for employment via the workforce office. The only requirements for enrolling are having a high school education and being fully vaccinated.

Phlebotomy and Additional Cross-training to Be Added

Doucette would eventually like to add a phlebotomy segment to future training sessions. “We would like to develop an additional partnership with BCCC (Baltimore City Community College) for the phlebotomy piece. That would definitely increase the people and the program’s marketability,” she said. “They could not only draw the blood, but they could also process the sample.”

After assessing the success of the current program and determining what did and did not work, there will be an additional training session held in the fall. Next year, there will be more sessions held for individuals in the workforce program and cross-training classes for current clinical laboratory professionals.

The strategy for the third year of the grant includes sharing the specifics of the program with medical laboratory professionals via the CDC’s free OneLab REACH platform. This portion includes the online delivery of documentation such as training sheets, lab exercises, Microsoft PowerPoint presentations, and videos used in both the accessioning and cross-training coursework.

“We’re going to do the OneLab REACH,” Doucette said. “I’m going to be putting it all online and marketing it all around the country in stages and increments. I will be going to a lot of professional society meetings and talking to lab managers to help them understand the concept of how this all benefits them.”

This unique collaboration between the City of Baltimore and University of Maryland School of Medicine, funded by the CDC, should help alleviate some of the clinical laboratory worker shortages that exist in the Baltimore area. Hopefully, the effort will result in additional knowledge, resources, and tools to assist medical lab managers across the country to recruit and retain talented, highly-skilled workers.   

JP Schlingman

Related Information:

Enhancing US Clinical Laboratory Workforce Capacity

What Is an Accessioner and How to Become One

Enhancing US Clinical Laboratory Workforce Capacity

93.322: CSELS Partnership: Strengthening Public Health Laboratories

NOFO OE22-2202: Enhancing US Clinical Laboratory Workforce Capacity—Frequently Asked Questions

NOFO OE22-2202: Enhancing US Clinical Laboratory Workforce Capacity—Q/A Session Transcript

Forbes Senior Contributor Covers Reasons for Growing Staff Shortages at Medical Laboratories and Possible Solutions

Medical Technologist Demand Exceeds Supply by Large Margin Across the United States as Clinical Laboratories Scramble to Stay Fully Staffed

Former Theranos CEO Elizabeth Holmes Fights Prison Sentence While Claiming She Was ‘Not Being Authentic’ with Public Image

Founder of now defunct clinical laboratory testing company was supposed to report to prison April 27, but a last-minute legal challenge has delayed that judge’s order

Anatomic pathologists and clinical laboratory leaders who are following the continuing saga of Theranos and Elizabeth Holmes may be interested to learn that the former CEO’s attorneys are making last-minute legal moves to delay her prison sentence while she appeals her guilty verdict. At the same time, Holmes appears to be on a mission to revamp her public image.

Apparently, the twists and turns in Holmes’ never-ending story are not yet over when it comes to Theranos, its maligned clinical laboratory technology, and the company’s convicted founder.

On May 7, The New York Times (NYT) profiled Holmes in a massive, 5,000-word story that attempted to portray her as a flawed businessperson who now prefers a simpler life with her partner and two young children.

Elizabeth Holmes

“I made so many mistakes and there was so much I didn’t know and understand, and I feel like when you do it wrong, it’s like you really internalize it in a deep way,” disgraced Theranos founder Elizabeth Holmes recently told The New York Times. Anatomic pathologists and clinical laboratory directors impacted by the revelation that Theranos hide the fact that its blood testing technology was faulty may not sympathize with Holmes’ position. (Photo copyright: Stuart Isett/Fortune Global Forum.)

Legal Team Secures Last-Minute Delay in Holmes’ Surrender

Holmes admitted to the news outlet that the deep voice she used in public, along with her black turtleneck sweaters, were part of a character she created.

“I believed it would be how I would be good at business and taken seriously and not taken as a little girl or a girl who didn’t have good technical ideas,” Holmes told the NYT. “Maybe people picked up on that not being authentic, since it wasn’t.”

Holmes was scheduled to report to a federal prison in Texas on April 27 after several unsuccessful motions were filed to delay the start of her sentence for the fraud convictions. Dark Daily covered Holmes’ conviction in “Disgraced Theranos Founder Elizabeth Holmes to Serve 11 Years, Three Months in Prison, Ending the Latest Chapter in the Story of the Failed Clinical Laboratory Company.”

However, on April 26, the 9th Circuit Court of Appeals stayed her surrender date until that court rules on Holmes’ latest bid to stay free while she appeals her conviction, The Washington Post reported.

Just days earlier on April 10, a district court judge ruled that Holmes would not stay free while her appeal progresses. The 9th Circuit announcement curtailed the district court ruling. It is not known when the 9th Circuit will issue a decision in the matter.

In “Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations,” Dark Daily reported that Holmes was convicted in January 2022 of defrauding Theranos investors out of $121 million. Theranos marketed a blood-testing machine called Edison, although it was later uncovered that results attributable to the technology were actually produced on traditional clinical laboratory analyzers.

New York Times Reports on Holmes’ Change in Personality

The somewhat odd New York Times profile of Holmes varied between reflections on her past crimes and on her current personal life, where she is known as “Liz.”

“In case you’re wondering, Holmes speaks in a soft, slightly low, but totally unremarkable voice—no hint of the throaty contralto she used while running her blood-testing startup Theranos, now defunct,” the NYT reported.

Holmes still lives in California with her partner, Billy Evans (whose parents own a luxury hotel chain), and their two children: a son who is almost two years old and a daughter born in February. She works at home for a rape-crisis hotline.

Balwani’s Role in Theranos Again Publicly Debated

In the NYT interview, Holmes talked about being raped while a student at Stanford University and about alleged abuse from her Theranos business partner and former lover, Ramesh “Sunny” Balwani.

Balwani, Theranos’ former President and Chief Operating Officer, began his 12-year, 11-month prison sentence on April 20 in a Southern California facility for his role in defrauding Theranos investors, KTVU TV reported. Balwani has also appealed his conviction on the 12 fraud charges.

Holmes reiterated to the NYT past statements she made in court that Balwani allegedly exerted social and sexual control over her when they both worked at Theranos and were in a romantic relationship.

“She lived by entrepreneurial tenets that she said Balwani told her she needed to follow in order to succeed,” the NYT reported. “These included not sleeping for more than five hours, going vegan, getting to the office daily by 5 a.m., no alcohol.”

“[I] deferred to [Balwani] in the areas he oversaw because I believed he knew better than I did,” including on clinical lab activities at Theranos, Holmes said.

Balwani’s attorneys dismissed Holmes’ allegations, as they have in the past.

Clinical laboratory professionals can reasonably make two broad observations from the continuing saga of Theranos and Elizabeth Holmes:

  • Justice for healthcare crimes is often deferred for those who have influence and money.
  • Holmes’ image overhaul may be a last-ditch effort to sway public opinion about her, in the event that she receives a new jury trial as a result of her appeal.

Dark Daily will continue to keep you updated on further developments in this case.

Scott Wallask

Related Information:

Liz Holmes Wants You to Forget about Elizabeth

Hot Startup Theranos Has Struggled with Its Blood-Test Technology

Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations

Holmes, Balwani Get Lengthy Prison Terms for Theranos Fraud

Disgraced Theranos Founder Elizabeth Holmes to Serve 11 Years, Three Months in Prison, Ending the Latest Chapter in the Story of the Failed Clinical Laboratory Company

Federal Prosecutors Seek $878 Million Restitution from Former Theranos Founder/CEO Elizabeth Holmes