Encouraging the next generation of clinical laboratorians could contribute to solving current staffing shortages in the nation’s medical laboratories
This holiday season brings an exciting new gift that will catch the attention of Dark Daily’s readers. It’s a children’s book that introduces young readers to working in clinical laboratories!
“This is a steppingstone into the career of laboratory science, so we should share what we do with the world. Any lab scientist who has a child, niece, nephew, or grandchild in their life should give this gift. It could open an entirely new world of possibilities for them. It could make them excited for science,” said the book’s author Kelli Garcia, microbiology supervisor at Saint Francis Hospital and Medical Center, part of Trinity Health of New England, in an exclusive interview with Dark Daily.
“Most children have a small idea or image of what options are available in medicine or science—usually a doctor or nurse. They never see the people that work behind the scenes or different areas,” Garcia noted.
She penned her book with hopes of calling attention to medical fields beyond those most commonly seen by children, as she also had only learned about the field when she was graduating from college.
“I Want to be a Laboratory Scientist,” is now available at many major retailers, including Amazon and Barnes and Noble. (Graphic copyright: Kelli Garcia.)
Opening Children’s Eyes
Garcia’s journey took about four years from the moment she began writing to finally finding a publisher for her 36-page book that’s geared toward 6-8 year-olds. “I spent many hours writing and rewriting so it wouldn’t be too specific but also not too minimal that the point and purpose would be missed,” she said, adding that her daughter was her muse.
Garcia’s own children have excitedly brought the book to their schools and shared them with their local library. Such steps could help a field that is working hard to keep up with demand.
“There are so many ways to engage children in different areas of science as long as we make those areas known to them. They don’t all wants to be a doctor or nurse, but some still want to help in another way. This book will show them you can be in medicine helping people but behind the scenes—the unsung hero,” microbiologist and children’s book author Kelli Garcia (above) told Dark Daily. She added, “It will also make them aware that laboratory science is a rewarding career and show that it’s not just doctors and nurses who are involved in treating patients.” (Photo copyright: Kelli Garcia.)
Those low numbers are not going unnoticed. The Medical Laboratory Personnel Shortage Relief Act of 2024, introduced in September by State Representative Deborah Ross (NC-02), was created to help bring a much-needed boost to the field. The Act brought in grants for clinical laboratory staff training in accredited institutions and added “medical laboratory professionals to the National Health Service Corps,” the ASCLS noted.
The ASCLS continues to encourage those working in clinical laboratories to make their voices heard on Capitol Hill to further support the field.
Hope is growing that more students will choose clinical laboratory work for their futures. Medical and clinical laboratory technologist was listed in Careers Fittest rankings of the top 14 careers to consider in 2024/2025. Careers Fittest cited an 11% job growth expected in the area by 2031.
It is a worthy objective to educate younger children about the career path of a clinical laboratory scientist and opportunities to work in microbiology laboratories. Perhaps Garcia’s new children’s book will help with that trend, and just in time for the holidays!
Incorrect results spanned exams from 2022-2024 with those students affected by this situation stunned by ABPath’s admission
There are always young anatomic pathologists who experience the heartache of failing board exams. Failing, after all, is part of the education process. But how disheartening would it be to learn years later that you actually passed those exams? For about 70 pathology students that’s exactly what happened.
On October 3, the American Board of Pathology (ABPath) announced that “a small percentage” of students were told they had failed an exam when they had not, MedPage Today reported. The test dates ranged from 2022 to 2024 and affected 76 students out of 4,059.
In its official statement, ABPath wrote that it had “recently conducted a reassessment and rescoring of the Primary and Subspecialty certification examinations. In doing so, ABPath identified that a small percentage of candidates (less than 2%) actually met the passing score requirements that were previously scored as slightly below the passing score threshold.”
The organization added, “The impacted candidates have all been notified. Those candidates received a passing score for their respective certification examination and will receive a refund of their application fee, as well as any fees paid toward subsequent examinations. Impacted training programs will be receiving notifications soon.”
According to MedPage Today, which received a copy of the email from a pathology student, “ABPath’s email to affected test takers was brief, explaining that a reassessment of the anatomic pathology certification examination ‘disclosed that your score exceeded the cut-score threshold for a passing score, rather than being slightly below it.’”
Many pathology students were stunned by ABPath’s admission and went to message boards to vent their frustration.
“Failing a major board hits you hard especially after so many years of training and so much time spend on studying. This situation was a shock, a disappointment, and a betrayal,” one former student identified as Idfcwytas wrote on Reddit concerning ABPath’s revelation, MedPage Today reported.
In its coverage of the ABPath announcement, MedPage Today wrote, “Bryan Carmody, MD (above), of Eastern Virginia Medical School in Norfolk, who blogs frequently about medical education issues, said that a situation like this decreases trust in the boards themselves, and that being mistakenly failed has financial and career impacts. For instance, he said, ‘many hospitals require board certification to get hospital privileges or to work there … so if you were applying to an academic job or something, I think it’s going to hurt your application.’” Anatomic pathologists understand clearly how lack of board certification affects their career goals. (Photo copyright: Eastern Virginia Medical School.)
ABPath’s Response and the Impact on Students
An ABPath spokesperson told MedPage Today, “We understand how significant this is to our candidates and diplomats and are committed to working closely with those impacted. ABPath has also implemented improvements to our processes to prevent this issue in the future.”
No details were disclosed on what changes would be made going forward, MedPage Today noted. As a result of the mistake, ABPath refunded exam fees and offered affected testers updated certificates and letters showing the proper results.
Some declared that response does not go far enough. Many claimed ABPath’s efforts lack adequate financial compensation as well as genuine compassion.
Reddit user walleyealx wrote, “The mistake definitely cost me LOTS of time, mental anguish, and money. Please note, there was no apology at all in these emails, which makes me even more angry,” MedPage Today reported.
Several days after the initial email, ABPath offered an apology “for the frustration this has caused,” according to MedPage Today.
No Recourse for Failing Grades
ABPath’s website notes that failed exams cannot be appealed. This means that any students doubting their scores during those years would not have been able to challenge the results.
“Even if the board offers a refund for the exams, it hardly makes up for the time, money, and lost career opportunities these individuals have had to deal with,” noted the Lento Law Firm in a blog post following ABPath’s announcement.
The firm added, “This incident only affected about 2% of exam takers from 2022 to 2024, but it’s a significant issue for these people. Not getting board certification can mean no hospital privileges, which can prevent you from obtaining certain jobs. Failing to get a certain specialty certification can also mean a $30,000 difference in your paycheck. Pathologists have only five years and 10 tries to pass the exam, which costs between $2,100 and $2,600 each time. Re-taking the exam after getting a failing score, therefore, represents a significant financial investment—not to mention the time spent studying.”
Implications of failure can be profound, but mistakes happen. ABPath appears to be taking steps to prevent similar mistakes in the future. Hopefully, the organization will also find a way to make whole those affected by its error.
Anatomic pathologists understand that, along with breast cancer, diagnostic testing for prostate cancer accounts for a high volume of clinical laboratory tests. Thus, a recent study indicating that a new artificial intelligence (AI)-based software tool can dramatically improve physicians’ ability to identify the extent of these cancers will be of interest.
“The study found that Unfold AI’s patient-specific encapsulation confidence score (ECS), which is generated based on multiple patient data points, including MRI scans, biopsy results, PSA [prostate-specific antigen] data, and Gleason scores, is critical for predicting treatment success,” an Avenda press release states. “These findings emphasize the importance of Unfold AI’s assessment of tumor margins in predicting treatment outcomes, surpassing the predictive capability of conventional parameters.”
“Unfold AI’s ability to identify tumor margins and provide the ECS will improve treatment recommendations and allow for less-invasive interventions,” said study co-author Wayne Brisbane, MD, a urologic oncologist and UCLA medical professor, in another press release. “This more comprehensive approach enhances our ability to predict treatment outcomes and tailor interventions effectively to individual patient needs.”
“This study is important because it shows the ability of AI to not only replicate expert physicians, but to go beyond human ability,” said study co-author Wayne Brisbane, MD (above), a urologic oncologist and UCLA medical professor, in a press release. “By increasing the accuracy of cancer identification in the prostate, more precise and effective treatment methods can be prescribed for patients.” Clinical laboratories that work with anatomic pathologists to diagnose prostate and other cancers may soon have a new AI testing tool. (Photo copyright: UCLA.)
How Unfold AI Works
To gauge the extent of prostate tumors, surgeons typically evaluate results from multiple diagnostic methods such as PSA tests and imaging scans such as MRIs, according to a UCLA press release. However some portions of a tumor may be invisible to an MRI, causing doctors to underestimate the size.
Unfold AI, originally known as iQuest, was designed to analyze data from PSA, MRI, fusion biopsy, and pathology testing, according to a company brochure. From there, it generates a 3D map of the cancer. Avenda’s website says the technology provides a more accurate representation of the tumor’s extent than conventional methods.
“Accurately determining the extent of prostate cancer is crucial for treatment planning, as different stages may require different approaches such as active surveillance, surgery, focal therapy, radiation therapy, hormone therapy, chemotherapy, or a combination of these treatments,” Brisbane said in the UCLA press release.
Putting AI to the Test
In the new study, the UCLA researchers enlisted seven urologists and three radiologists to review 50 prostate cancer cases. Each patient had undergone prostatectomy—surgical removal of all or part of the prostate—but might have been eligible for focal therapy, a less-aggressive approach that uses heat, cryotherapy, or electric shocks to attack cancer cells more selectively.
The physicians came from five hospitals and had a wide range of clinical experience from two to 23 years, the researchers noted in The Journal of Urology.
They reviewed clinical data and examined MRI scans of each patient, then “manually drew outlines around the suspected cancerous areas, aiming to encapsulate all significant disease,” the press release states. “Then, after waiting for at least four weeks, they reexamined the same cases, this time using AI software to assist them in identifying the cancerous areas.”
The researchers analyzed the physicians’ work, evaluating the accuracy of the cancer margins and the “negative margin rate,” indicating whether the clinicians had identified all of the cancerous tissue. Using conventional approaches, “doctors only achieved a negative margin 1.6% of the time,” the press release states. “When assisted by AI the number increased to 72.8%.”
The clinicians’ accuracy was 84.7% when assisted by AI versus 67.2% to 75.9% for conventional techniques.
They also found that clinicians who used the AI software were more likely to recommend focal therapy over more aggressive forms of treatment.
“We saw the use of AI assistance made doctors both more accurate and more consistent, meaning doctors tended to agree more when using AI assistance,” said Avenda Health co-founder and CEO Shyam Natarajan, PhD, who was senior author of the study.
“These results demonstrate a marked change in how physicians will be able to diagnose and recommend treatment for prostate cancer patients,” said Natarajan in a company press release. “By increasing the confidence in which we can predict a tumor’s margins, patients and their doctors will have increased certainty that their entire tumor is treated and with the appropriate intervention in correlation to the severity of their case.”
UCLA’s study found that AI can outperform doctors both in sensitivity (a higher detection rate of positive cancers) and specificity (correctly detecting the sample as negative). That’s relevant and worth watching for further developments.
Pathologists and clinical laboratory managers should consider this use of AI as one more example of how artificial intelligence can be incorporated into diagnostic tests in ways that allow medical laboratory professionals to diagnose disease earlier and more accurately. This will improve patient care because early intervention for most diseases leads to better outcomes.
Clinical laboratories and anatomic pathology groups should consider these cyberattacks on major healthcare entities as reminders that they should tighten their cybersecurity protections
Hackers continue to gain access to public health records—including clinical laboratory testing data—putting thousands of patients’ protected health information (PHI) at risk of being exposed. The latest important healthcare entity to become the victim of a ransomware attack is American Associated Pharmacies (AAP). According to The Register, AAP announced a ransomware operation called Embargo had stolen over 1.4 terabytes (TB) of data, encrypted those files, and demanded $1.3 million to decrypt the data.
Embargo claims that Scottsboro, Ala.-based AAP paid $1.3 million to have its systems restored. They are now demanding an additional $1.3 million to keep the stolen data private, the HIPAA Journal reported, adding, “The attack follows ransomware attacks on Memorial Hospital and Manor, an 80-bed community hospital and 107 long-term care facility in Georgia, and Weiser Memorial Hospital, a critical access hospital in Idaho.”
AAP has not publicly confirmed the ransomware attack, nor has it made an official statement regarding the breach. But it did post an “Important Notice” on its website reporting, “limited ordering capabilities for API Warehouse have been restored at APIRx.com.”
API Warehouse is a subsidiary of AAP that helps subscribers save on brand name and generic prescriptions via wholesale purchasing plans. It oversees more than 2,000 independent pharmacies across the US and has over 2,500 stock keeping units (SKUs) in its inventory.
The message further states “All user passwords associated with both APIRx.com and RxAAP.com have been reset, so existing credentials will no longer be valid to access the sites. Please click ‘forgot password’ on the log in screen and follow the prompts accordingly to reset your password.”
“Embargo seems to have international and multi-sector victims and is not focusing on a specific victim profile. They seem opportunistic,” Mike Hamilton (above), founder and chief information security officer (CISO) of cybersecurity firm Critical Insight, told HealthcareInfoSecurity. “However, as they do have multiple victims in healthcare, and their tooling to disable detection is sophisticated, they should not be discounted. If indeed they operate through affiliates, we can expect others to use their infrastructure and tools, and Embargo may emerge as a top threat to healthcare.” Since 80% of all medical records are made up of clinical laboratory testing data, laboratory patients are particularly vulnerable. (Photo copyright: Critical Insight.)
Embargo on the Hunt for PHI
Due to the large amount of data Embargo stole from the AAP servers, it’s likely the hackers were able to procure medical records and account details from all customers of the pharmacies involved in the attack.
Researchers at ESET, an internet security company, first noticed the ransomware organization known as Embargo in June of this year. In a news release, ESET stated that Embargo used an endpoint detection and response (EDR) killer toolkit to steal AAP’s data.
“Based on its modus operandi, Embargo seems to be a well-resourced group. It sets up its own infrastructure to communicate with victims. Moreover, the group pressures victims into paying by using double extortion: the operators exfiltrate victims’ sensitive data and threaten to publish it on a leak site, in addition to encrypting it,” ESET wrote in a news release.
Embargo recently attacked other organizations within the healthcare industry as well. In November, it claimed responsibility for breaching the security of Memorial Hospital and Manor in Bainbridge, Ga. The cyberattack affected Memorial’s email and electronic medical record (EHR) systems, which caused the facility to pivot to a paper-based system, The Cyber Express reported.
Embargo’s attack on Weiser Memorial Hospital in Weiser, Idaho, involved the theft of approximately 200 gigabytes (GB) of sensitive data and caused a four-week-long outage of its computer systems.
Other Cyberattacks on Healthcare Organizations
Dark Daily has covered many cyberattacks on hospital health systems in multiple ebriefs over the past few years.
Safeguarding patient data is critical, and more healthcare organizations are discovering the hard way that they are vulnerable to hackers. This situation serves as another reminder to clinical laboratory and pathology group managers that they need to be proactive and serious about protecting their information systems, and in upgrading their digital security at regular intervals.
Hackers are working hard to obtain access to protected health information, which puts patients at continuous risk of having their private records stolen.
Half of the people tested were unaware of their genetic risk for contracting the disease
Existing clinical laboratory genetic screening guidelines may be inadequate when it comes to finding people at risk of hereditary breast-ovarian cancer syndromes and Lynch syndrome (aka, hereditary nonpolyposis colorectal cancer). That’s according to a study conducted at the Mayo Clinic in Rochester, Minn., which found that about half of the study participants were unaware of their genetic predisposition to the diseases.
Mayo found that 550 people who participated in the study (1.24%) were “carriers of the hereditary mutations.” The researchers also determined that half of those people were unaware they had a genetic risk of cancer, and 40% did not meet genetic testing guidelines, according to a Mayo Clinic news story.
The discoveries were made following exome sequencing, which the Mayo Clinic news story described as the “protein-coding regions of genes” and the sites for most disease-causing mutations.
“Early detection of genetic markers for these conditions can lead to proactive screenings and targeted therapies, potentially saving lives of people and their family members,” said lead author Niloy Jewel Samadder, MD, gastroenterologist and cancer geneticist at Mayo Clinic’s Center for Individualized Medicine and Comprehensive Cancer Center.
“This study is a wake-up call, showing us that current national guidelines for genetic screenings are missing too many people at high risk of cancer,” said lead author Niloy Jewel Samadder, MD (above), gastroenterologist and cancer geneticist at Mayo Clinic’s Center for Individualized Medicine and Comprehensive Cancer Center. New screening guidelines may increase the role of clinical laboratories in helping physicians identify patients at risk of certain hereditary cancers. (Photo copyright: Mayo Clinic.)
Advancing Personalized Medicine
“The goals of this study were to determine whether germline genetic screening using exome sequencing could be used to efficiently identify carriers of HBOC (hereditary breast and ovarian cancer) and LS (Lynch syndrome),” the authors wrote in JCO Precision Oncology.
For the current study, Helix, a San Mateo, Calif. population genomics company, collaborated with Mayo Clinic to perform exome sequencing on the following genes:
BRCA1 and BRCA2 genes (hereditary breast and ovarian cancer).
Mayo/Helix researchers performed genetic screenings on more than 44,000 study participants. According to their published study, of the 550 people who were found to have hereditary breast cancer or Lynch syndrome:
387 had hereditary breast and ovarian cancer (27.2% BRCA1, 42.8% BRCA2).
163 had lynch syndrome (12.3% MSH6, 8.8% PMS2, 4.5% MLH1, 3.8% MSH2, and 0.2% EPCAM).
Participants recruited by researchers hailed from Rochester, Minn.; Phoenix, Ariz.; and Jacksonville, Fla.
Minorities were less likely to meet the NCCN criteria than those who reported as White (51.5% as compared to 37.5%).
“Our results emphasize the importance of expanding genetic screening to identify people at risk for these cancer predisposition syndromes,” Samadder said.
Exome Data in EHRs
Exomes of more than 100,000 Mayo Clinic patients have been sequenced and the results are being included in the patients’ electronic health records (EHR) as part of the Tapestry project. This gives clinicians access to patient information in the EHRs so that the right tests can be ordered at the right time, Mayo Clinic noted in its article.
“Embedding genomic data into the patient’s chart in a way that is easy to locate and access will assist doctors in making important decisions and advance the future of genomically informed medicine.” said Cherisse Marcou, PhD, co-director and vice chair of information technology and bioinformatics in Mayo’s Clinical Genomics laboratory.
While more research is needed, Mayo Clinic’s accomplishments suggest advancements in gene sequencing and technologies are making way for data-driven tools to aid physicians.
As the cost of gene sequencing continue to fall due to improvement in the technologies, more screenings for health risk factors in individuals will likely become economically feasible. This may increase the role medical laboratories play in helping doctors use exomes and whole genome sequencing to screen patients for risk of specific cancers and health conditions.
Although it is a non-specific procedure that does not identify specific health conditions, it could lead to new biomarkers that clinical laboratories could use for predictive healthcare
Researchers from the Mayo Clinic recently used artificial intelligence (AI) to develop a predictive computational tool that analyzes an individual’s gut microbiome to identify how a person may experience improvement or deterioration in health.
Dubbed the Gut Microbiome Wellness Index 2 (GMWI2), Mayo’s new tool does not identify the presence of specific health conditions but can detect even minor changes in overall gut health.
Built on an earlier prototype, GMWI2 “demonstrated at least 80% accuracy in differentiating healthy individuals from those with any disease,” according to a Mayo news release. “The researchers used bioinformatics and machine learning methods to analyze gut microbiome profiles in stool samples gathered from 54 published studies spanning 26 countries and six continents. This approach produced a diverse and comprehensive dataset.”
“Our tool is not intended to diagnose specific diseases but rather to serve as a proactive health indicator,” said senior study author Jaeyun Sung, PhD (above), a computational biologist at the Mayo Clinic Center for Individualized Medicine: Microbiomics Program in the news release ease. “By identifying adverse changes in gut health before serious symptoms arise, the tool could potentially inform dietary or lifestyle modifications to prevent mild issues from escalating into more severe health conditions, or prompt further diagnostic testing.” For microbiologists and clinical laboratory managers, this area of new knowledge about the human microbiome may lead to multiplex diagnostic assays. (Photo copyright: Mayo Clinic.)
Connecting Specific Diseases with Gut Microbiome
Gut bacteria that resides in the gastrointestinal tract consists of trillions of microbes that help regulate various bodily functions and may provide insights regarding the overall health of an individual. An imbalance in the gut microbiome is associated with an assortment of illnesses and chronic diseases, including cardiovascular issues, digestive problems, and some cancers and autoimmune diseases.
To develop GMWI2, the Mayo scientists provided the machine-learning algorithm with data on microbes found in stool samples from approximately 8,000 people collected from 54 published studies. They looked for the presence of 11 diseases, including colorectal cancer and inflammatory bowel disease (IBS). About 5,500 of the subjects had been previously diagnosed with one of the 11 diseases, and the remaining people did not have a diagnosis of the conditions.
The scientists then tested the efficacy of GMWI2 on an additional 1,140 stool samples from individuals who were diagnosed with conditions such as pancreatic cancer and Parkinson’s disease, compared with those who did not have those illnesses.
The algorithm gives subjects a score between -6 and +6. People with a higher GMWI2 score have a healthier microbiome that more closely resembles individuals who do not have certain diseases.
Likewise, a low GMWI2 score suggests the individual has a gut microbiome that is similar to those who have specific illnesses.
Highly Accurate Results
According to their study, the researchers determined that “GMWI2 achieves a cross-validation balanced accuracy of 80% in distinguishing healthy (no disease) from non-healthy (diseased) individuals and surpasses 90% accuracy for samples with higher confidence,” they wrote in Nature Communications.
Launched in 2020, the original GMWI (Gut Microbiome Wellness Index) was trained on a much smaller number of samples but still showed similar results.
The researchers tested the enhanced GMWI2 algorithm across various clinical schemes to determine if the results were similar. These scenarios included individuals who had previous fecal microbiota transplants and people who had made dietary changes or who had exposure to antibiotics. They found that their improved tool detected changes in gut health in those scenarios as well.
“By being able to answer whether a person’s gut is healthy or trending toward a diseased state, we ultimately aim to empower individuals to take proactive steps in managing their own health,” Sung said in the news release.
The Mayo Clinic team is developing the next version of their tool, which will be known as the Gut Microbiome Wellness Index 3. They plan to train it on at least 12,000 stool samples and use more sophisticated algorithms to decipher the data.
More research and studies are needed to determine the overall usefulness of Mayo’s Gut Microbiome Wellness Index and its marketability. Here is a world-class health institution disclosing a pathway/tool that analyzes the human microbiome to identify how an individual may be experiencing either an improvement in health or a deterioration in health.
The developers believe it will eventually help physicians determine how patients’ conditions are improving or worsening by comparing the patients’ microbiomes to the profiles of other healthy and unhealthy microbiomes. As this happens, it would create a new opportunity for clinical laboratories to perform the studies on the microbiomes of patients being assayed in this way by their physicians.
