Inability to access clinical laboratory test results forced hospitals to suspend critical procedures and surgeries causing major disruptions to healthcare
Cyberattacks continue to shut down the ability of hospitals to process orders for clinical laboratory tests, medical imaging, and prescriptions. One such cyberattack recently took place against Ascension, the largest nonprofit Catholic health system in the United States. It took more than a month for the health network’s electronic health record (EHR) system to be fully restored, according to a cybersecurity event press release.
Immediately following the event, Ascension announced it had hired a third party company to resolve the fallout from the cyberattack.
“On Wednesday, May 8, we detected unusual activity on select technology network systems, which we now believe is due to a cybersecurity event. … Access to some systems have been interrupted … We have engaged Mandiant, a third party expert, to assist in the investigation and remediation process, and we have notified the appropriate authorities,” a press release states.
Based in Reston, Va., Mandiant is an American cybersecurity firm and a subsidiary of Google.
Cyberattacks are happening more frequently and medical professionals need to be aware that patient care can be severely disrupted by such attacks. The Ascension attack locked its employees out of the healthcare provider’s computer databases, rendering medical personnel unable to track and coordinate patient care. The health network’s EHR, phones, and databases used to order certain clinical laboratory tests, imaging services, procedures, and medications were all affected.
Hospital employees, including two doctors and a registered nurse, spoke anonymously to the Detroit Free Press regarding the issues at their facilities resulting from the cyberattack.
“It’s so, so dangerous,” said the nurse, describing the immediate aftermath of the cyberattack. “We are waiting four hours for head CT [computed tomography scan] results on somebody having a stroke or a brain bleed. We are just waiting. I don’t know why they haven’t at least paused the ambulances and accepting transfers because we physically … don’t have the capacity to care for them right now.”
“In some cases, what are supposed to be unique medical record numbers assigned to patients when they register in the emergency department at Ascension St. John [Detroit, Mich.] have been given to more than one patient at a time,” Detroit Free Press reported. “Because of that, the nurse told the Free Press she couldn’t be confident that a patient’s blood test results actually were his own.”
“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” Jeff Tully, MD (above), Associate Clinical Professor, Anesthesiology, and co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego, told NPR. “These types of cybersecurity incidents should be thought of as a matter of when and not if,” he added. Inability to verify clinical laboratory test results or access patients’ electronic medical records endangers patients and undermines the confidence of critical healthcare workers. (Photo copyright: UC San Diego.)
Losing Track of Patients and Their Records
According to the HIPAA Journal’sH1, 2024 Healthcare Data Breach Report, “In H1 [first half of the fiscal year], 2024, 387 data breaches of 500 or more [healthcare] records were reported to OCR, which represents an 8.4% increase from H1, 2023, and a 9.3% increase from H1, 2022.”
After the Ascension cyberattack, the healthcare organization’s computer systems were inoperable, and its pharmacy services were temporarily closed. Medical orders for clinical laboratory testing, imaging tests, and prescriptions had to be handwritten on paper and faxed to appropriate departments, which led to long wait times for patients.
There were cases where singular medical record numbers were assigned to multiple patients. Staff resorted to Google documents, paper charting, and text messaging to communicate with one another. But they still lost track of some patients.
“For a lot of our nurses, they’ve never paper charted at all,” said Connie Smith, a charge capture coordinator and head of the Wisconsin Federation of Nurses and Health Professionals, in a ThinkStack blog post. “We were using forms that we pulled out of drawers that hadn’t seen the light of day in a long, long time.”
“They are texting me to find out where the patient went,” a St. John Hospital Emergency Room physician anonymously told the Free Press immediately following the Ascension cyberattack. “They don’t even know where the patient is going or if they’ve been admitted. People are getting lost.
“The pharmacy is getting requests for patient medications, and they have no idea where the patient is in the hospital,” the doctor continued. “Some of the attending physicians are putting in orders for medications, somewhat dangerous medications, and we have no idea if the medications are actually being administered. It’s a scary thing when your medical license is tied to this. If medication mistakes become lawsuits, they will follow us throughout our entire careers and that is not fair to us. It’s not fair to patients.”
According to online updates provided by Ascension, the cyberattack began when an employee downloaded a malicious file thinking it was a legitimate document. That allowed hackers to access seven of Ascension’s 25,000 servers. The resulting cyberattack stifled operations across the organization’s facilities and among its healthcare providers for weeks.
A June 12 update read, “we are pleased to announce that electronic health record (EHR) access has been restored across our ministries. This means that clinical workflow in our hospitals and clinics will function similarly to the way it did prior to the ransomware attack.” The updates did not mention how the attack was resolved or if a ransom was paid to restore the hospitals’ systems.
Preparing for System Disruptions
According to its website, St. Louis-based Ascension has 134,000 associates, 35,000 affiliated providers, and 140 hospitals serving communities in 18 states and the District of Columbia.
“Despite the challenges posed by the recent ransomware incident, patient safety continues to be our utmost priority. Our dedicated doctors, nurses, and care teams are demonstrating incredible thoughtfulness and resilience as we utilize manual and paper based systems during the ongoing disruption to normal systems,” Ascension noted in a Michigan Cybersecurity Event Update.
Clinical laboratory managers and anatomic pathology practice administrators may want to learn from Ascension’s experience and make advanced preparations that will secure patient information and enable their lab to continue functioning during a cyberattack. The Ascension cyberattack illustrates how easily computer systems containing critical information can be hacked and affect patient care.
Clinical laboratory scientists and microbiologists could play a role in helping doctors explain to patients the potential dangers of do-it-yourself medical treatments
Be careful what you wish for when you perform do-it-yourself (DIY) medical treatments. That’s the lesson learned by a woman who was seeking relief for irritable bowel syndrome (IBS). When college student Daniell Koepke did her own fecal transplant using poop from her brother and her boyfriend as donors her IBS symptoms improved, but she began to experience medical conditions that afflicted both fecal donors.
“It’s possible that the bacteria in the stool can influence inflammation in the recipient’s body, by affecting their metabolism and activating their immune response,” microbial ecologist Jack Gilbert, PhD, Professor and Associate Vice Chancellor at University of California San Diego (UC San Diego) told Business Insider. “This would cause shifts in their hormonal activity, which could promote the bacteria that can cause acne on the skin. We nearly all have this bacterium on skin, but it is often dormant,” he added.
A Fecal Microbiota Transplant (FMT) is a procedure where stool from a healthy donor is transplanted into the microbiome of a patient plagued by a certain medical condition.
Our guts are home to trillions of microorganisms (aka, microbes), known as the gut microbiota, that serve many important functions in the body. The microbiome is a delicate ecosystem which can be pushed out of balance when advantageous microbes are outnumbered by unfavorable ones. An FMT is an uncomplicated and powerful method of repopulating the microbiome with beneficial microbes.
“With fecal microbiome transplants there is really compelling evidence, but the science is still developing. We’re still working on if it actually has benefits for wider populations and if the benefit is long-lasting,” said Gilbert in a Netflix documentary titled, “Hack Your Health: The Secrets of Your Gut.”
“The microbial community inside our gut can have surprising influences on different parts of our body,” microbial ecologist Jack Gilbert, PhD (above), of the Gilbert Lab at University of California San Diego told Business Insider. “Stools are screened before clinical FMTs, and anything that could cause major problems, such as certain pathogens, would be detected. When you do this at home, you don’t get that kind of screening.” Doctors and clinical laboratories screening patients for IBS understand the dangers of DIY medical treatments. (Photo copyright: University of California San Diego.)
Changing Poop Donors
When Koepke began experiencing symptoms of IBS including indigestion, stabbing pains from trapped gas and severe constipation, she initially turned to physicians for help.
In the Netflix documentary, Koepke stated that she was being prescribed antibiotics “like candy.” Over the course of five years, she completed six rounds of antibiotics per year, but to no avail.
She also changed her diet, removing foods that were making her symptoms worse. This caused her to lose weight and she eventually reached a point where she could only eat 10 to 15 foods.
“It’s really hard for me to remember what it was like to eat food before it became associated with anxiety and pain and discomfort,” she said.
In an attempt to relieve her IBS symptoms, Koepke made her own homemade fecal transplant pills using donated stool from her brother. After taking them her IBS symptoms subsided and she slowly gained weight. But she developed hormonal acne just like her brother.
Koepke then changed donors, using her boyfriend’s poop to make new fecal transplant pills. After she took the new pills, her acne dissipated but she developed depression, just like her boyfriend.
“Over time, I realized my depression was worse than it’s ever been in my life,” Koepke stated in the documentary.
She believes the microbes that were contributing to her boyfriend’s depression were also transplanted into her via the fecal transplant pills. When she reverted to using her brother’s poop, her depression abated within a week.
Gilbert told Business Insider his research illustrates that people who suffer from depression are lacking certain bacteria in their gut microbiome.
“She may have had the ‘anti-depressant’ bacteria in her gut, but when she swapped her microbiome with his, her anti-depressant bacteria got wiped out,” he said.
FDA Approves FMT Therapy for Certain Conditions
Typically, the fecal material for an FMT procedure performed by a doctor comes from fecal donors who have been rigorously screened for infections and diseases. The donations are mixed with a sterile saline solution and filtered which produces a liquid solution. That solution is then administered to a recipient or frozen for later use.
On November 30, 2022, the US Food and Drug Administration (FDA) approved the first FMT therapy, called Rebyota, for the prevention of Clostridioides difficile (C. diff.) in adults whose symptoms do not respond to antibiotic therapies. Rebyota is a single-dose treatment that is administered rectally into the gut microbiome at a doctor’s office.
Then, in April of 2023, the FDA approved the use of a medicine called Vowst, which is the first oral FMT approved by the FDA.
According to the Cleveland Clinic, scientists are exploring the possibility that fecal transplants may be used as a possible treatment for many health conditions, including:
Doctors and clinical laboratories know that do-it-yourself medicine is typically not a good idea for obvious reasons. Patients seldom appreciate all the implications of the symptoms of an illness, nor do they fully understand the potentially dangerous consequences of self-treatment. Scientists are still researching the benefits of fecal microbiota transplants and hope to discover more uses for this treatment.
Cellular healthcare is an approach that goes beyond clinical laboratory testing to identify the location of specific cancer cells and aid in treatment decisions
Advances in synthetic biology and genetic engineering are leading to development of bacterial biosensors that could eventually aid pathologists and clinical laboratories in diagnosis of many types of cancers.
One recent example comes from researchers at the University of California San Diego (UCSD) who worked with colleagues in Australia to engineer bacteria that work as “capture agents” and bind to tumorous material.
The KRAS gene is associated with colorectal cancer. The researchers named their development the Cellular Assay for Targeted CRISPR-discriminated Horizontal gene transfer (CATCH).
CATCH successfully detected cancer in the colons of mice. The researchers believe it could be used to diagnose cancers, as well as infections and other diseases, in humans as well, according to a UCSD news release.
“If bacteria can take up DNA, and cancer is defined genetically by a change in its DNA, then, theoretically, bacteria could be engineered to detect cancer,” gastroenterologist Daniel Worthley, PhD, a cancer researcher at Colonoscopy Clinic in Brisbane, Australia, told MedicalResearch.com. This research could eventually provide clinical laboratories and anatomic pathologists with new tools to use in diagnosing certain types of cancer. (Photo copyright: Colonoscopy Clinic.)
Tapping Bacteria’s Natural Competence
In their Science paper, the researchers acknowledged other synthetic biology achievements in cellular biosensors aimed at human disease. But they noted that more can be done by leveraging the “natural competence” skill of bacteria.
“Biosensors have not yet been engineered to detect specific extracellular DNA sequences and mutations. Here, we engineered naturally competent Acinetobacter baylyi (A. baylyi) to detect donor DNA from the genomes of colorectal cancer cells, organoids, and tumors,” they wrote.
“Many bacteria can take up DNA from their environment, a skill known as natural competence,” said Rob Cooper, PhD, co-first author of the study and a scientist at US San Diego’s Synthetic Biology Institute, in the news release. A. baylyi is a type of bacteria renowned for success in doing just that, the NCI article pointed out.
This enabled them to explore “free-floating DNA sequences on a genomic level.”
Those sequences were compared to “known cancer DNA sequences.”
A. baylyi (genetically modified) was tested on its ability to detect “mutated and healthy KRAS DNA.”
Only bacteria that had “taken up mutated copies of KRAS … would survive treatment with a specific drug.”
“It was incredible when I saw the bacteria that had taken up the tumor DNA under the microscope. The mice with tumors grew green bacterial colonies that had acquired the ability to be grown on antibiotic plates,” said Josephine Wright, PhD, Senior Research Fellow, Gut Cancer Group, South Australian Health and Medical Research Institute (SAHMRI), in the news release.
Detecting DNA from Cancer Cells In Vitro and in Mice
Findings in vitro and in mice include the following:
The engineered bacteria enabled detection of DNA with KRAS G12D from colorectal cancer cells made in the lab, NCI reported.
When mice were injected with colorectal cancer cells, the researchers’ technology found tumor DNA, Engadget reported.
The study adds to existing knowledge of horizontal gene transfer from bacteria to bacteria, according to UCSD.
“We observed horizontal gene transfer from the tumor to the sensor bacteria in our mouse model of colorectal cancer. This cellular assay for targeted, CRISPR-discriminated horizontal gene transfer (CATCH) enables the biodetection of specific cell-free DNA,” the authors wrote in Science.
“Colorectal cancer seemed a logical proof of concept as the colorectal lumen is full of microbes and, in the setting of cancer, full of tumor DNA,” gastroenterologist Daniel Worthley, PhD, a cancer researcher at Colonoscopy Clinic in Brisbane, Australia, told MedicalResearch.com.
Finding More Cancers and Treatment
More research is needed before CATCH is used in clinical settings. The scientists are reportedly planning on adapting CATCH to multiple bacteria that can locate other cancers and infections.
“The most exciting aspect of cellular healthcare … is not in the mere detection of disease. A laboratory can do that,” wrote Worthley in The Conversation. “But what a laboratory cannot do is pair the detection of disease (a diagnosis) with the cells actually responding to the disease [and] with appropriate treatment.
“This means biosensors can be programmed so that a disease signal—in this case, a specific sequence of cell-free DNA—could trigger a specific biological therapy, directly at the spot where the disease is detected in real time,” he added.
Clinical laboratory scientists, pathologists, and microbiologists may want to stay abreast of how the team adapts CATCH, and how bacterial biosensors in general continue to develop to aid diagnosis of diseases and improve ways to target treatment.
These new insights might lead to a new line of clinical laboratory testing, particularly if the results could guide the patient to microbiome-based repellents that would remain effective for months once applied
Researchers are beginning to identify what compounds make individuals more attractive to mosquitos. That is a first step in the development of a biomarker that could be developed into a clinical laboratory test. Question is: would there be enough consumers wanting to do a lab test to determine if they were highly attractive to mosquitos, thus making this a revenue-generating test for labs?
The SA article reported on their study published in the journal Cell titled, “Differential Mosquito Attraction to Humans Is Associated with Skin-Derived Carboxylic Acid Levels.” The researchers, according to SA, found that individual humans have “a unique scent profile made up of different chemical compounds” and that “mosquitoes were most drawn to people whose skin produces high levels of carboxylic acids.” The researchers also found that “attractiveness to mosquitoes remained steady over time, regardless of changes in diet or grooming habits.”
At a minimum, there would be widespread consumer interest to at least understand why some individuals get more mosquito bites than others. What may be of particular interest to microbiologists is the statement by molecular biologist Omar Akbari, PhD, of the University of California, San Diego, who told Scientific American that by “taking human-colonizing skin bacteria … and engineering them in such a way that they can either express a repellent compound or be able to degrade something that’s attractive,” a mosquito repellant could be developed that would last for months once applied.
“This study clearly shows that these acids are important,” neurogeneticist Matthew DeGennaro, PhD (above), told CNN. “… how the mosquitoes perceive these carboxylic acids is interesting because these particular chemicals … are hard to smell at a distance. It could be that these chemicals are being altered by … the skin microbiome … if we understand why mosquitoes find a host, we can design new repellents that will block the mosquitoes from sensing those chemicals, and this could be used to improve our current repellents.” Clinical laboratory testing will be needed to produce biomarkers for developing such improved repellents. (Photo copyright: Laboratory of Tropical Genetics.)
Clinical Laboratory Testing Needed to Identify Levels of Carboxylic Acids
To complete their study, the researchers had 64 participants wear nylon stockings for six hours on their arms to get their unique scent into the fabric. The scent on the stockings was not discernible to the human nose, but it was to the mosquitos.
Two pieces of the nylon were then placed in a closed container with Aedes aegypti mosquitoes. The researchers found that certain samples were more popular with the mosquitos than others. Upon further analysis the researchers found that the most popular samples came from subjects with higher levels of carboxylic acids, and the least popular had the lowest levels. The scientists ran the test with the same participants several times over three years and the results remained largely the same.
Carboxylic acid is an organic compound found in humans in sebum, the oily layer protecting our skin. The level at which humans release carboxylic acid varies from person to person. And there is no discernible way the human nose can determine whether a person has the level of carboxylic acid on the skin that mosquitos find desirable. The answer would need to be determined by a diagnostic test performed in a clinical laboratory.
Although the development of a test to determine someone’s susceptibility to mosquitos may be far away, there could be significant consumer interest in developing such a test.
“The question of why some people are more attractive to mosquitoes than others—that’s the question that everybody asks,” Leslie B. Vosshall, PhD, Chief Scientific Officer, Howard Hughes Medical Institute, who led the research team to find out why some people are more attractive to mosquitos than others, told Scientific American. “My mother, my sister, people in the street, my colleagues—everybody wants to know.” She credits their interest as the inspiration for embarking on the study.
“Understanding what makes someone a ‘mosquito magnet’ will suggest ways to rationally design interventions such as skin microbiota manipulation to make people less attractive to mosquitoes. We propose that the ability to predict which individuals in a community are high attractors would allow for more effective deployment of resources to combat the spread of mosquito-borne pathogens,” the researchers wrote in their Cell paper.
Preventing Spread of Deadly Diseases
Although mosquitos are an annoyance, they also can be dangerous vectors of disease.
“Every bite of these mosquitoes puts people into public health danger. Aedes aegypti mosquitoes are vectors for dengue, yellow fever, and Zika,” Vosshall told CNN. “Those people who are magnets are going to be much more likely to be infected with viruses.”
Further research into these early findings may help develop diagnostic tests to protect against the spread of these diseases and identify individuals who are more attractive to the mosquitos, and therefore, more likely to contract and spread disease.
Being able to identify which individuals are mosquito magnets could help keep individuals safe from dangerous diseases, and development of a better repellent could also make outdoor summer events more bearable for the (unfortunately) popular among the pests. Medical laboratory tests associated with determining an individual’s susceptibility to mosquito bites could give clinical laboratories a new way to add value to consumers and patients.
Researchers surprised that process designed to detect SARS-CoV-2 also identifies monkeypox in wastewater
Early information about an outbreak in a geographical region can inform local clinical laboratories as to which infectious agents and variants they are likely to see when testing patients who have symptoms. To that end, wastewater testing has become a rich source of early clues as to where COVID-19 outbreaks are spreading and how new variants of the coronavirus are emerging.
Ongoing advances in genetic sequencing and digital technologies are making it feasible to test wastewater for infectious agents in ways that were once too time-consuming, too expensive, or simply impossible.
“Before wastewater sequencing, the only way to do this was through clinical testing, which is not feasible at large scale, especially in areas with limited resources, public participation, or the capacity to do sufficient testing and sequencing,” said Knight in a UCSD press release. “We’ve shown that wastewater sequencing can successfully track regional infection dynamics with fewer limitations and biases than clinical testing to the benefit of almost any community.” (Photo copyright: UC San Diego News.)
Same Process, Different Virus
Following August’s declaration of a state of emergency by California, San Diego County, and the federal government, UCSD researchers added monkeypox surveillance to UCSD’s existing wastewater surveillance program.
“It’s the same process as SARS-CoV-2 qPCR monitoring, except that we have been testing for a different virus. Monkeypox is a DNA virus, so it is a bit of a surprise that our process optimized for SARS-CoV-2, which is an RNA virus, works so well,” said Rob Knight, PhD, Professor of Pediatrics and Computer Science and Engineering at UCSD and one of the lead authors of the study in the press release.
According to the press release, RNA sequencing from wastewater has two specific benefits:
It avoids the potential of clinical testing biases, and
It can track changes in the prevalence of SARS-CoV-2 variants over time.
In 2020, at the height of the COVID-19 pandemic, scientists from the University of California San Diego and Scripps Research looked into genetic sequencing of wastewater. They wanted to see if it would provide insights into levels and variants of the SARS-CoV-2 within a specific community.
Individuals who have COVID-19 shed the virus in their stool.
The UCSD/Scripps researchers deployed commercial auto-sampling robots to collect wastewater samples at the main UCSD campus. They analyzed the samples for levels of SARS-CoV-2 RNA at the Expedited COVID-19 Identification Environment (EXCITE) lab at UCSD. After the success of the program on the campus, they extended their research to include other facilities and communities in the San Diego area.
“The coronavirus will continue to spread and evolve, which makes it imperative for public health that we detect new variants early enough to mitigate consequences,” said Knight in a July press release announcing the publication of their study in the journal Nature, titled, “Wastewater Sequencing Reveals Early Cryptic SARS-CoV-2 Variant Transmission.”
Detecting Pathogens Weeks Earlier than Traditional Clinical Laboratory Testing
In July, the scientists successfully determined the genetic mixture of SARS-CoV-2 variants present in wastewater samples by examining just two teaspoons of raw sewage. They found they could accurately identify new variants 14 days before traditional clinical laboratory testing. They detected the presence of the Omicron variant 11 days before it was first reported clinically in the community.
During the study, the team collected and analyzed 21,383 sewage samples, with most of those samples (19,944) being taken from the UCSD campus. They performed genomic sequencing on 600 of the samples and compared them to genomes obtained from clinical swabs. They also compared 31,149 genomes from clinical genomic surveillance to 837 wastewater samples taken from the community.
The scientists distinguished specific viral lineages present in the samples by sequencing the viruses’ complete set of genetic instructions. Mutational differences between the various SARS-CoV-2 variants can be minute and subtle, but also have notable biological deviations.
“Nothing like this had been done before. Sampling and detection efforts began modestly but grew steadily with increased research capacity and experience. Currently, we’re monitoring almost 350 buildings on campus,” said UCSD’s Chancellor Pradeep Khosla, PhD, in the July press release.
“The wastewater program was an essential element of UC San Diego Health’s response to the COVID pandemic,” said Robert Schooley, MD, Infectious Disease Specialist at UC San Diego Health, in the press release. Schooley is also a professor at UCSD School of Medicine, and one of the authors of the study.
“It provided us with real-time intelligence about locations on campus where virus activity was ongoing,” he added. “Wastewater sampling essentially allowed us to ‘swab the noses’ of every person upstream from the collector every day and to use that information to concentrate viral detection efforts at the individual level.”
Monkeypox Added to UCSD Wastewater Surveillance
In August, UCSD officially added the surveillance of the monkeypox virus to their ongoing wastewater surveillance program. A month earlier, the researchers had discerned 10,565.54 viral copies per liter of wastewater. They observed the levels fluctuating and increasing.
On August 2, the scientists detected 189,309.81 viral copies per liter of wastewater. However, it is not yet clear if the monitoring of monkeypox viral loads in wastewater will enable the researchers to accurately predict future infections or case rates.
“We don’t yet know if the data will anticipate case surges like with COVID,” Knight said in the August UCSD press release announcing the addition of monkeypox to the surveillance program. “It depends on when the virus is shed from the body relative to how bad the symptoms are that cause people to seek care. This is, in principle, different for each virus, although in practice wastewater seems to be predictive for multiple viruses.”
Utilization of genetic sequencing of wastewater sampling will continue to develop and improve. “It’s fairly easy to add new pathogens to the process,” said Smruthi Karthikeyan, PhD, an environmental engineer and postdoctoral researcher in Knight’s lab who has overseen wastewater monitoring at UC San Diego. “It’s doable on short notice. We can get more information in the same turnaround time.”
Thus, clinical laboratories engaged in testing programs for COVID-19 may soon see the addition of monkeypox to those processes.
