Plaintiffs claim state is criminalizing speaking the truth about their earned advanced degrees
Doctorate of Nursing Practice (DNP) is the highest degree that can be acquired by a nurse practitioner (NP). But can NPs who achieve this degrees call themselves doctors? What about others who hold doctorates, such as PhDs in clinical laboratories?
According to the State of California—which has enacted a law restricting the use of the word “doctor” or the prefix “Dr.” in titles, online, or in business communications solely to physicians and surgeons—the answer is no.
They are seeking to block enforcement of the law, according to The Washington Post.
“The word ‘doctor’ doesn’t belong to physicians,” Jacqueline Palmer, DNP, one of the three NPs suing over California’s law restricting non-physician medical providers from using that word, told The Washington Post. Palmer argues that NPs should be able to use the word “doctor” or the prefix “Dr.” when describing themselves much like PhDs and other non-physicians do who hold doctorates. (Photo copyright: Jacqueline Palmer, DNP.)
Section 2054 of the statute states, “Any person who uses in any sign, business card, or letterhead, or, in an advertisement, the words doctor or physician, the letters or prefix Dr., the initials M.D., or any other terms or letters indicating or implying that he or she is a physician and surgeon, physician, surgeon, or practitioner under the terms of this or any other law, or that he or she is entitled to practice hereunder, or who represents or holds himself or herself out as a physician and surgeon, physician, surgeon, or practitioner under the terms of this or any other law, without having at the time of so doing a valid, unrevoked, and unsuspended certificate as a physician and surgeon under this chapter, is guilty of a misdemeanor.”
In their complaint, the three lawsuit plaintiffs state, “Defendants are California state officials charged with enforcing a law that criminalizes the truthful use of the title ‘Dr.’ by any healthcare professional who is not a licensed physician or surgeon. That means veterinarians, dentists, pharmacists, physical therapists, and nurse practitioners are subject to severe penalties if they truthfully refer to themselves as ‘doctor.’ This is true even where the doctor specifies the specific profession in which he or she has obtained his or her doctorate degree. The statute that mandates this regime goes far beyond patient protection and violates the First Amendment rights of doctors to truthfully describe themselves and their credentials.”
California is not the only state that restricts the use of the word “doctor” or “Dr.” but it is the strictest, according to Donna Matias, JD, Pacific Legal Foundation, the attorney representing the three plaintiffs.
“If you read the law literally, it appears to prohibit even PhDs and university professors from using the title,” she told the Post.
Previous Case Led to Stiff Penalties for Nurse Practitioner
In November of 2022, California Nurse Practitioner Sarah Erny, DNP, was fined a total of $22,500 by both the State of California and the State Medical Association for describing herself as a doctor on several professional online platforms without also including that she was a nurse, not a physician.
“While in most instances Ms. Erny indicated that she was a nurse practitioner, she failed to advise the public that she was not a medical doctor and failed to identify her supervising physician. Adding to the lack of clarity caused by referring to herself as ‘Dr. Sarah,’ online search results would list ‘Dr. Sarah Erny,’ without any mention of Ms. Erny’s nurse status,” wrote County of San Luis Obispo District Attorney Dan Dow, JD, in a statement.
Dow went on to say, “All forms of professional medical services advertising, including websites and social media accounts, must be free of deceptive or misleading information and must clearly identify the professional license held by the advertiser. Providing patients upfront with the proper title of our healthcare professionals aids consumers in making a more informed decision about their healthcare.”
Along with the financial penalties, Erny was ordered to “refrain from referring to herself as ‘doctor’ in her role of providing medical treatment to the public. [The judgement] also requires Ms. Erny to identify and make reasonable efforts to correct information on internet sites referring to her as ‘doctor’ or ‘Dr.’” the statement noted.
Speaking Truthfully about Advanced Degrees
Palmer spent 14 years in school pursuing her degrees. She feels her patients are smart enough to know the difference between her and a physician. “It’s not an ego trip; it’s not a power trip,” Palmer told the Post, “It’s just validation that I worked hard to get where I am today.”
The Pacific Legal Foundation argues in favor of the nurses by virtue of their advanced and in-depth training: “[After] years earning their advanced degrees and qualifications … they should be able to speak truthfully about them in their workplaces, on their business cards, the internet, and social media, so long as they clarify that they are nurse practitioners.”
Until the dust settles, NPs in California are taking precautions. Palmer said she has asked her patients to stop calling her “doctor” out of fear of being fined like Erny, a move she also claimed her patients protested against. “They all have said that they know that I worked hard for it,” she told the Post.
Clinical laboratory PhDs and others with advanced degrees may want to investigate their state’s requirements as to how they can legally refer to themselves.
Technology enables sampling of an individual’s microbiome over time to observe changes associated with different illnesses or different diets
There is now a pill-sized device that can non-invasively collect and deliver a sample of gut bacteria taken directly from specific areas of a person’s gastrointestinal (GI) tract. One benefit of this new technology is that it can collect samples from the upper digestive system. Although not ready for clinical use, this is the kind of technology that would enable microbiologists and clinical laboratory scientists to add more microbiome assays to their test menu.
Researchers at Stanford University, Envivo Bio, and the University of California, Davis (UC Davis) have developed a vitamin capsule-sized device—dubbed CapScan—that can measure the microbial, viral, and bile acid profiles contained in the human intestines as it passes through on its way to being expelled.
Currently, scientists rely on stool samples to collect similar data as they are easy to gather and readily available. However, stool samples may not provide the most accurate analysis of the various microorganisms that reside in the human gut.
“Measuring gut metabolites in stool is like studying an elephant by examining its tail,” said Dari Shalon, PhD, Founder and CEO at Envivo Bio, one of the authors of the study, in a UC Davis news release. “Most metabolites are made, transformed, and utilized higher up in the intestines and don’t even make it into the stool. CapScan gives us a fuller picture of the gut metabolome and its interactions with the gut microbiome for the first time.” Shalon is the inventor of the CapScan device.
This demonstrates how technological advancements are giving scientists new diagnostic tools to guide selection of therapies and to monitor a patient’s progress.
Microbiologists will take a special interest in this published study because, once confirmed by further studies, it would provide microbiology laboratories and clinical labs with a new way to collect samples. In clinical laboratories throughout the country, handling fecal specimens is considered an unpleasant task. Once cleared for clinical use, devices like CapScan would be welcomed because the actual specimen would be contained within the capsule, making it a cleaner, less smelly specimen to handle than conventional fecal samples.
“This capsule and reports are the first of their kind,” said Oliver Fiehn, PhD, Professor of Molecular and Cell Biology at UC Davis, in a news release. “All other studies on human gut microbiota focused on stool as a surrogate for colon metabolism. However, of course, the fact is that 90% of human digestion happens in the upper intestine, not the colon.” Clinical laboratories have long worked with stool samples to perform certain tests. If CapScan proves clinically viable, labs may soon have a new diagnostic tool. (Photo copyright: UC Davis.)
Collecting Small Intestine Microbiota
Human digestion occurs mostly in the small intestine where enzymes break down food particles so they can later be absorbed through the gut wall and processed in the body. Stool samples, however, only sample the lower colon and not the small intestine. This leaves out vital information about a patient.
“The small intestine has so far only been accessible in sedated people who have fasted, and that’s not very helpful,” Oliver Fiehn, PhD, Professor of Molecular and Cell Biology at UC Davis and one of the study authors, said in the news release.
According to their Nature paper, to perform their research the team recruited 15 healthy adults to participate in the study. Each participant swallowed four CapScan “pills,” either twice daily or on two consecutive days. The pills were designed to respond to different pH (potential of hydrogen) levels.
Each pill’s pH-sensitive outer coating enables scientists to select which area of the intestinal tract to sample. The outer coating dissolves at a certain point as it travels from the upper intestine to the colon. When this happens, a one-way valve gathers miniscule amounts of biofluids into a tiny, inflatable bladder. Once full, the bladder seals shut and the CapScan continues its journey until it is recovered in the stool. The researchers then genetically sequenced the RNA from the collected samples.
The scientists discovered that the microbiome varied substantially at distinctive sections of the GI tract. When compared to collected stool samples, the researchers determined that traditional stool sampling could not capture that variability.
“There’s enormous potential as you think about how the environment is changing as you go down the intestinal tract,” Kerwyn Huang, PhD, Professor of Bioengineering and of Microbiology and Immunology at Stanford, one of the authors of the study, told Drug Discovery News. “Identifying how something like diet or disease affects the variation in the individual microbiome may even provide the potential to start discovering these important health associations.”
The genetic sequencing also revealed which participants had taken antibiotics within one to five months before the study because their data was so incongruous with the other participants. Those individuals had distinctive differences in their microbiome and bile acid composition, which illustrates that antibiotics can potentially affect gut bacteria even months after being taken.
Researchers Use Multiple ‘Omics’ Approach
The researchers used “multiomics” to analyze the samples. They identified the presence of 2,000 metabolites and found associations between metabolites and diet.
According to the Envivo Bio website, the CapScan allows for the regional measurement of:
“Overall, this device can help elucidate the roles of the gut microbiome and metabolome in human physiology and disease,” Fiehn said in the press release.
Future of Collecting Gut Bacteria
Using CapScan is a non-invasive procedure that makes it possible to sample an individual’s microbiome once, or to monitor it over time to observe changes associated with different illnesses or diets. Since it takes time for the device to pass through the digestive system, it is not a rapid test, but initial studies show it could be more accurate than traditional clinical laboratory testing.
“This technology makes it natural to think about sampling from many places and many times from one person, and it makes that straightforward and inexpensive,” Huang said.
Advancements in technology continue to provide microbiology and clinical laboratories with new, innovative tools for diagnosing and monitoring diseases, as well as guiding therapy selection by medical professionals. Though more research and clinical studies are needed before a device like the CapScan can be commonly used by medical professionals, it may someday provide a cutting-edge method for collecting microbiome samples.
Sales of SARS-CoV-2 tests at other IVD companies, including Roche Diagnostics and Danaher’s lab businesses also report declines in COVID-19 test revenue
Clinical laboratory leaders and pathologists seeking a marker that the COVID-19 pandemic has passed may have it in the plunge in SARS-CoV-2 test revenue during the second quarter at Abbott Laboratories, Abbott Park, Illinois.
COVID-19 test sales in Q2 2023 at Abbott fell a “whopping” 89% as people try to “move on” from the SARS-CoV-2 outbreak, the Chicago Tribune reported.
Developer of the BinaxNOW rapid COVID-19 antigen self-test, Abbott saw its COVID-19 sales revenue decline from $2.3 billion in Q2 2022 to $263 million in the quarter ending June 30, the Chicago Tribune noted.
The decline was expected by Abbott. Nonetheless, the company will likely sell more than $1 billion in COVID-19 tests by the end of this year—business it did not have in 2019.
Abbott lowered its forecast for COVID-19 sales in 2023 to $1.3 billion, down from $1.5 billion, MedTech Dive reported.
“We decided to bring our COVID-19 number down a couple of hundred million dollars, because we’re seeing—as the public health emergency ended—a little bit of a decline in testing,” said Abbott’s Chairman and CEO Robert Ford during an earnings call transcribed by Motley Fool. “So, we’ll see how that’s going to play out in Q4 (2023), the first quarter we will see an endemic respiratory season.” Clinical laboratories that performed high numbers of SARS-CoV-2 test during the pandemic will likely experience similar declines in test volumes. [Photo copyright: Abbott Laboratories.)
Overall, Abbott Has ‘Good Recovery’
COVID-19-related diagnostics was just part of the financial report by Abbott, which also develops other clinical laboratory tests, clinical laboratory analyzers and automation, medical devices, pharmaceuticals, and nutritional products such as infant formula.
Abbott said in a news release that its sales—driven by base business performance—were $10 billion in Q2.
“We have had a really, really good recovery here as the health systems are opening up, and are seeing routine testing come back,” said Abbott’s Chairman and CEO Robert Ford during the earnings call.
Here are diagnostics financial results for Q2 2023 as compared to Q2 2022, according to the news release:
Diagnostic sales fell to $2.3 billion from $4.2 billion.
Core laboratory sales were flat at $1.2 billion.
Molecular sales plunged to $141 million from $212 million.
Rapid diagnostics plummeted to $741 million from $2.7 billion.
As need for COVID-19 testing contracts, Abbott is focusing on research and development of assays that may be “missing on the menus,” Ford said during the earnings call.
“We’ve been working on expanding the menu in molecular and point-of-care. One of the most exciting assays that the team has developed for point-of-care is a rapid test for traumatic brain injury,” he added.
COVID-19 Revenue Falls at Roche, Danaher
Abbott is not the only in vitro diagnostics (IVD) manufacturer to report a recent significant decline in demand for COVID-19 products.
Another sign the major wave of the pandemic has passed is the dramatic fall in COVID-19 product revenue at Roche to 0.4 billion Swiss Francs (CHF) (US$460 million) from 3.1 billion CHF (US$3.5 billion) in the first half of 2022, according to a Roche news release.
The Basel, Switzerland company—reporting on six months of financial results—said its Roche Group base business increased 8% and Diagnostics Division base business rose 6% in 2023, as compared to the first six months last year.
Diagnostics Division sales overall fell 23% to 7 billion CHF (US$8 billion) from 9.9 billion CHF (US$11.3 billion), Roche said.
Here are more first-half of 2023 financial results at Roche as compared to the same period in 2022:
Core lab: 3.9 billion CHF ($US 4.4 billion), up 10% from 3.8 billion CHF (US$4.3 billion).
Molecular lab: 1.1 billion CHF (US$1.2 billion), down 40% from 1.9 billion CHF (US$2.1 billion).
Diabetes care: 723 million CHF (US$831.7 million), down 5% from 832 million CHF (US$957 million).
Pathology lab: 687 million CHF (US$790 million), up 12% from 652 million CHF (US$750 million).
Point of care: 635 million CHF (US$730.6 million), plummeted 74% from 2.6 billion CHF (US$2.9 billion).
“In the first half of 2023, sales in the base business of both of our divisions (diagnostics and pharmaceuticals) grew strongly, largely offsetting the impact of declining demand for COVID-19 products,” said Roche CEO Thomas Schinecker, PhD, in the news release.
COVID-19 May Linger as IVD Companies Refresh Menus
As the COVID-19 pandemic wanes, healthcare providers will continue to test patients for the SARS-CoV-2 coronavirus.
But it also appears that IVD companies are aiming to keep their instruments—which ran full tilt performing COVID-19 testing during the pandemic—of high value to clinical laboratories by developing new tests for possible inclusion on labs’ testing menus.
Advances in genome sequencing give virologists and microbiologists new tools for tracking SARS-CoV-2 variants to their sources
Wastewater surveillance has emerged as an essential tool in the detection and tracking of the SARS-CoV-2 coronavirus within communities. Though COVID-19 infections are decreasing in the United States—and clinical laboratories are performing fewer diagnostic tests for the disease—researchers continue to monitor populations for the presence of the coronavirus and its variants to be prepared for the next outbreak.
Genetic sequencing of samples extracted from sewer systems throughout the country have revealed dozens of strains of the coronavirus containing multiple mutations in unusual combinations called cryptic genetic variants (CVG), also known as cryptic lineages. A recent study has indicated that wastewater may also provide answers to questions about long COVID as these mutations can be traced back to individuals who are living with chronic COVID-19 infections.
“Because increases in wastewater [viruses] generally occur before corresponding increases in clinical cases, wastewater surveillance serves as an early warning system for the emergence of COVID-19 in a community,” said Amy Kirby, PhD (above), CDC program lead for the National Wastewater Surveillance System, during a media telebriefing. Wastewater testing for viruses and bacteria may eventually lead to the implementation of systems to alert clinical laboratories in a region whenever infectious agents are detected in wastewater. (Photo copyright: Center for Global Safe Water, Sanitation, and Hygiene.)
Humans Found to Be Primary Source of Cryptic Lineages
To conduct their study, scientist at the University of Wisconsin-Madison and the University of Missouri School of Medicine examined the evolution of a SARS-CoV-2 Omicron subvariant found in wastewater coming from a single facility in Wisconsin that employed about 30 people. The researchers discovered the mutation had been present in the wastewater for more than a year.
Dark Daily originally covered their findings in “New, Cryptic COVID-19 Lineage Found in Ohio Wastewater by Molecular Virologist Tracking Spread of SARS-CoV-2 Variants.” We reported how scientists had tracked the lineage of the cryptic strain to Ohio, where it appeared to have originated from one individual who travels regularly between the cities of Columbus and Washington Court House. They believed the person had a form of long COVID and was unaware that he or she was infected with the coronavirus.
According to Marc Johnson, PhD, Professor of Microbiology and Immunology at the University of Missouri and one of the authors of the study, the individual who shed the mutations had been shedding at least a thousand times more COVID-19 virus than an average infected person sheds. The scientists examined other wastewater monitoring data and identified 37 related cases in the US. They concluded that humans are the main source of the cryptic lineages.
“The fact that someone can have this kind of infection—and there’s every indication that they are still an active member of society and not just lying in the hospital—it’s just amazing,” Johnson told CNN.
Wastewater Surveillance Not an Exact Science, CDC Says
Although not directly involved in this study, through its National Wastewater Surveillance System (NWSS) the US Centers for Disease Control and Prevention (CDC) has been tracking wastewater surveillance programs. The federal agency believes cryptic lineages do not pose a threat to public health.
“The signal we really look for is specific variants increasing in frequency in a community, because that’s what happens at the beginning of a variant surge,” Amy Kirby, PhD, Health Scientist, National Wastewater Surveillance System Lead for the CDC, told CNN. “And it’s not what we’re seeing with these cryptic lineages.”
Kirby also noted that wastewater surveillance is not an exact science and that many factors can impede the interpretation of the data. The mutations observed for this study could be from people with long COVID or even from an infected animal. To be certain of the results, she said, researchers would have to directly link the genetic sequence from a clinical test to a specific wastewater sample.
“Best-case scenario is you find the person, they have long COVID but had no idea they had this infection, and you get them with a doctor who can get them on medicines that will actually give their immune system a bit of an upper hand, and they get better,” Johnson told CNN. “But we only know about the ones we can find, and we don’t know what the implications are, because we still don’t know who those people are.”
Public health messaging in local communities is needed to raise awareness. But though tracking down specific infected individuals could help them receive medical attention, it may not be the most desirable course of action.
“Part of the power of wastewater surveillance is that it is inherently anonymous. It’s a community-level surveillance method,” Kirby said. “And so, tracking back through the wastewater system to identify a person is not what the system is intended for.”
Clinical Laboratories Play Key Role in Public Health
The cryptic lineage that Johnson and his team identified was a mutation that appeared in two watersheds in Ohio—one located in southern Columbus and one in the town of Washington Court House, which is about 40 miles south of Columbus. The researchers hypothesized that an individual living in that area had COVID for more than two years and did not know it, was most likely asymptomatic, and lives in one area and spends a lot of time (perhaps working) in the other area.
“There is almost zero chance the patient in Ohio knew about their infection. There is almost zero chance their doctor would figure it out. It is very likely the infection is causing long term damage,” Johnson wrote in a Twitter tweet. “I’m glad that there is a chance now that they might get appropriate care.”
Wastewater surveillance has materialized as a common method of identifying and monitoring strains of COVID-19 and other infectious diseases. And clinical laboratories play a key role in that process. With genetic sequencing technologies becoming more advanced, lower in cost, faster and more accurate, it’s feasible that those technologies will be utilized more to direct public health initiatives.
Genetic scientists show how rapid WGS is helping doctors determine best treatments for patients with life-threatening conditions
Clinical laboratory scientists will recall that last year, Dark Daily covered how researchers at Stanford University School of Medicine had developed a method for performing rapid whole genomic sequencing (WGS) in as little as five hours. We predicted that their new ultra-rapid genome sequencing approach could lead to significantly faster diagnostics and improved clinical laboratory treatments for cancer and other diseases. And it has.
The research scientist responsible for that breakthrough is cardiologist and Associate Dean of Stanford University School of Medicine, Euan Ashley, MD, PhD. Ashley is also a professor of genomics and precision health, cardiovascular medicine, genetics, and biomedical data science and pathology.
Ashley’s success demonstrates that the drive to reduce the diagnostic time to answer is a market dynamic encouraging research companies to continue finding ways to make WGS faster to accomplish, cheaper to perform, and the DNA sequences generated more accurate.
It is precisely these developments that will provide clinical laboratories and anatomic pathology groups with new means for improving diagnosis and the identification of the most appropriate therapies for individual patients—a core element of precision medicine.
Ashley’s team is now looking at how faster genetic sequencing results could help physicians make life-and-death treatment decisions, STAT reported.
“There’s just never been a better time to be doing genomics,” cardiologist Euan Ashley, MD, PhD, Associate Dean of the Stanford University School of Medicine, told STAT. “Now there are lots of choices. If you’re a genome center and you need to do half a million genomes, you’re going to be extremely price-sensitive. If you’re a clinical lab, where you get a few exomes and a few genomes every day, and what really matters to you is the highest possible accuracy for diagnosis, then you’re definitely going to make a different choice,” he added. (Photo copyright: euanangusashley.com.)
Getting Crucial Genetic Information Faster
Ashley believes that if doctors who work with rare and deadly diseases get crucial genetic information faster, they can more precisely determine which surgical procedures are best for their patients during life-or-death situations.
Already, his work is proving highly successful. In a letter his team published in the New England Journal of Medicine (NEJM), the researchers reported 12 cases of sequencing seriously ill patients, five of whom were diagnosed in seven hours and 18 minutes. Every single case resulted in tangible changes in treatments given to the patients.
“We continue to be interested in sequencing genomes faster and more accurately, for a broader range of clinical applications. We’re recruiting from intensive care units similar kinds of patients to the ones we did before, but with every aspect of the pipeline upgraded, which helps both from a speed but also from an accuracy perspective,” he told STAT.
Ashley and his team continue to delve into the patient care aspects, striving to continue to make a big impact. In addition, the group is being sought out by cancer doctors who need faster diagnoses.
“We also have a lot of interest from cancer doctors saying it’s really important to make a cancer diagnosis quickly. And of course, there is no person who’s ever had the specter of cancer hanging over them for a moment that didn’t want some kind of an answer faster. If you can have it in the next minute, you would take it rather than waiting several weeks,” he noted.
As a result, the group has initiated pilot studies “to look at returning results faster in the same way that we were speeding up the intensive care unit with whole genome sequencing,” Ashley told STAT.
Though the work is in the early stages, the team has a few scenarios where access to genetic data changes medical decision making. For instance, when genetic test results showing a positive BRCA variant alter a doctor’s surgical plan.
“We don’t wait for a cardiac enzyme [test] if somebody’s having a heart attack. That comes back within 10 minutes to a few hours from the lab. I don’t see why you should have to wait for a test to tell you if you’re positive for BRCA variant,” he told STAT.
“Another very obvious place is acute leukemia. And there’s a number of actionable conditions where if they can be detected rapidly, then treatment can be started faster,” he added.
Improving Genetic Sequencing Accuracy while Lowering Costs
STAT asked Ashley about a claim that his team could cut their Guinness World Record sequencing time in half.
“It’s easy to throw that number around, harder to deliver on it. But I think we’re definitely on track to knock hours, not minutes, off that record,” he said.
Additionally, the team continues to work on decreasing cost per genome. In just the time since the record was set, there has already been great strides in this area. The market is filled with new companies and the competition has lowered costs.
“It has definitely come down,” Ashely noted. “In fact, by the time we ended up publishing the [NEJM] paper—as opposed to when we first did this calculation—the cost was already lower. And that was actually before the entry of these new companies to the market, which added downward pressure on costs of sequencing,” he added.
Getting Payers to Reimburse for Genetic Sequencing
Even though costs for WGS is dropping, getting health plans to reimburse for genetic testing remains difficult.
“The challenge now is persuading payers to the very obvious fact that this technology makes patients’ lives better and saves them money,” Ashley told STAT. “And that’s the amazing part. There are so many cost-effectiveness studies now for this technology and yet we are still paying people to sit on the phone all day long and debate with insurance companies.
“And in a world where we pay a very large amount of money for therapeutics, these diagnostics can be cost-saving and lifesaving. At some level, it’s hard to understand why it hasn’t been deployed much more readily,” he concluded.
Clinical laboratory leaders, pathologists, and research scientists should continue to monitor the development of rapid genetic sequencing for diagnostic purposes.
Australian government rules lab employee’s rogue actions jeopardized patient care
In an example of “if something can go wrong in the lab, it will,” a senior histology laboratory worker at Royal North Shore Hospital in Sydney, Australia, has been banned for life from providing health services for allegedly swapping patient tissue samples in an attempt to harm a lab co-worker, according to The Sydney Morning Herald.
Dianne Reader, 61, was a “a senior technical officer at the Anatomical Pathology Laboratory with more than 40 years’ experience,” the Herald noted, adding that Reader “had swapped 20 patient tissue samples, leading to the misdiagnosis of at least one patient.”
Her motivation, the Herald reported, was to “target and discredit her colleague.”
“Ms. Reader repeatedly engaged in conduct that demonstrated a flagrant disregard for patient health and safety” that may have “serious adverse consequences for the patients involved,” Tony Kofkin at Australia’s Health Care Complaints Commission told The Sydney Morning Herald. This is a lesson that clinical laboratory managers can never be too diligent because something unexpected can happen at any moment—and these events have the potential to cause serious patient harm. (Photo copyright: LinkedIn.)
Lab Staff Suspicions Raised
The sample mixups began in 2020, when the targeted employee (employee A) was working specimen “cut-up” duty. After two incidents of sample mixups being found in her work, she was removed from the duty for three weeks. The Herald reported that the employee told a co-worker she believed she was being “framed.” When she returned to cut-up duty, she took photographs of her work as a precautionary measure.
The employee’s photos served as evidence when that day’s work again showed errors, now the third incident of sample mixups. Upon further research, a total of four occasions of swapping samples were discovered between March and June of 2020.
Laboratory records showed that Reader was responsible for unpacking the tissue processor on each of those occasions, the Herald noted.
Lab workers noted a strained working relationship between Reader and the targeted employee. “One co-worker, a hospital scientist, told the [Health Care Complaints Commission] the working relationship between Reader and ‘Employee A’ could be ‘frosty,’” the Herald reported.
Lab staff apparently grew suspicious when a co-worker discovered that Reader “was only looking up gall bladder and appendices samples on the mornings Employee A had been ‘cutting up’ (dissecting and describing samples before placing them into cassettes for processing).” Lab staff also confirmed to the Health Care Complaints Commission that Reader had improperly accessed 43 patient records, adding that “there was no reason for her to have accessed the records when she did,” The Sydney Morning Herald reported.
Reader, according to the Herald, “denied she had ever interchanged specimens or improperly accessed patient files in two recorded interviews in July 2020, and maintains her innocence.”
Nevertheless, Tony Kofkin, the Commission’s complaint operations Executive Director, found that Reader “posed a risk to the health and safety of the public because she was prepared to risk patient safety in order to discredit her colleague.
“Ms. Reader repeatedly engaged in conduct that demonstrated a flagrant disregard for patient health and safety,” he wrote in the Commission’s findings, adding that Reader “had shown no remorse or insight into her conduct ‘despite the overwhelming evidence’ and as such posed a permanent risk to the health and safety of the public,” the Herald reported.
The Health Care Complaints Commission determined that Reader’s actions were “motivated by a desire to target and discredit her colleague.” The Commission’s decision prevents Reader from forever providing healthcare services, including medical, hospital, pharmaceutical, forensic pathology, or health education services, according to the Herald.
Who Was Harmed by the Swapped Samples?
Reader’s alleged actions had significant consequences. One patient’s swapped sample nearly led her to having a hysteroscopy for a glandular polyp, when in fact she was suffering with endometrial hyperplasia. Thankfully, the histology laboratory staff discovered the mistake and quickly contacted the patient’s doctor to ensure the proper surgery was performed, the Herald noted.
Things could have gone much worse for that patient and for others. Clinical laboratory managers should look upon this as a cautionary tale and consider how to ensure similar—and very rare—occurrences do not happen in their own laboratories.
