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.
Technology like Apple’s VR/AR headsets may prove useful to clinical laboratories in accessioning and in pathology labs during biopsy grossing
In what has been billed as a first, medical teams in the US and UK used Apple’s Extended Reality (XR) Vision Pro headset system to assist in surgical procedures. The surgeons themselves did not wear the $3,500 headset. Instead, surgical nurses used the device for touch-free access to a software application that assisted them in setting up, organizing, and performing the operations. For pathologists and clinical laboratories, in the histology laboratory, such an arrangement involving XR headsets could be used when a biopsy is at the grossing station as well.
The headset software the team used during surgery was developed by eXpanded eXistence, Inc. (eXeX), a Florida-based company whose primary product is an iOS (Apple mobile operating system) application that provides similar functions for mobile devices. eXeX adapted the iOS app to work on Apple’s Extended Reality headset.
Extended Reality is an umbrella term for augmented reality (AR) and virtual reality (VR). Apple refers to the technology as “spatial” computing.
Within the clinical laboratory, XR headsets could be used in the accessioning process as the accessioner works through the steps to confirm all required information accompanies the test requisition and that the patient’s specimen is processed/aliquoted appropriately.
“The eXeX platform, enhanced by artificial intelligence, is designed not as a medical device but as an organizational and logistics tool. It aims to streamline the management of tens of thousands of items, including equipment, tools, technologies, consumables, implants, and surgical products,” said neurosurgeon Robert Masson, MD, eXeX’s founder and CEO, in a February news release.
Masson first deployed the software in his own surgical practice. Then in March, eXeX announced that a surgical team at Cromwell Hospital in London used the system in two microsurgical spine procedures, according to a March new release.
That news garnered media coverage in the UK as well as in US-based publications that follow Apple.
“We are in a new era of surgery, and for the first time, our surgical teams have the brilliance of visual holographic guidance and maps, improving visuospatial and temporal orientation for each surgical team and for each surgery in all specialties,” said neurosurgeon Robert Masson, MD (above), eXeX’s founder and CEO, in a press release. Clinical laboratories may one day use XR headsets in the histology lab at the grossing station. (Photo copyright: Masson Spine Institute.)
Surgical Process Not Glamorous, But Important
Despite being on a cutting-edge XR platform, the eXeX software addresses “the least glamorous part” of the surgical process, Masson told Gizmodo.
“People assume that surgical healthcare has got to be sophisticated and modern,” he said. “The reality is the way we organize it is probably the most archaic of all the major industries on the planet. It’s all memorization and guesswork with scribbles on pieces of paper.”
The advantage of an XR headset is that it allows use of the eXeX software in a sterile environment, he added. “The ability to interact with digital screens and holograms and lists and maps and products unlocks all kinds of possibilities. Suddenly, you’ve got an interactive digital tool that you can use without violating the sanctity of sterility.”
Does he foresee a future when the surgeons themselves use XR headsets in the operating room? Not necessarily, Masson told Gizmodo.
“There’s always a tendency to say, ‘look at this amazing tech, let’s put a screw in with it,’” he said. “Well, we’re already putting screws in without the headset, so it doesn’t really solve a problem. People tend to think of floating spines, floating heights, you know, an overlay that tells you where to put a catheter in the liver. Honestly, it’s all unnecessary because we already do that pretty well. What we don’t do really well is stay organized.”
Other XR Apps for Healthcare
In a news release, Apple showcased other healthcare apps for its Vision Pro platform.
Epic Systems, an electronic health record (EHR) system developer, has an app called Epic Spatial Computing Concept that allows clinicians “to easily complete charting, review labs, communicate using secure chat, and complete in-basket workflows through intuitive gestures, like simply tapping their fingers to select, flicking their wrist to scroll, or using a virtual keyboard or dictation to type,” Apple stated in the news release.
Stryker, manufacturer of Mako surgical robotic arms for joint-replacement procedures, has an Apple iOS app called myMako that “allows surgeons to visualize and review patients’ Mako surgical plans at any time in a brilliant, immersive visual experience,” Apple said.
Cinematic Reality, from Siemens Healthineers, is an Apple iOS app that “allows surgeons, medical students, and patients to view immersive, interactive holograms of the human body captured through medical scans in their real-world environment,” Apple said.
New Era in Technology
For the past 20 years, manufacturing companies have installed systems at workstations with audio and video that show each step in a work process and with written checklists on the computer screen. This allows workers to check off each required step as proof that each required work element was performed.
This is similar to professional pilots who use checklists at every step in a flight process. One pilot will read the checklist items, the other will perform the step and confirm it was complete.
These procedures are generally completed on computer displays, but with the advent of XR headset technology, these types of procedures are evolving toward mobility.
To prepare for the emergence of XR-based healthcare apps, the US Food and Drug Administration (FDA) has organized a research team to devise best practices for testing these headset devices, CNBC reported.
It will be some time before XR headset technology finds its way into histology laboratories, clinical laboratories, and pathology practices, but since the rate of technology adoption accelerates exponentially, it might not take very long.
Infection control teams and clinical laboratory managers may want to look at this new product designed to improve the diagnosis and treatment of sepsis
Accurate and fast diagnosis of sepsis for patients arriving in emergency departments is the goal of a new product that was just cleared by the federal Food and Drug Administration (FDA). It is also the newest example of how artificial intelligence (AI) continues to find its way into pathology and clinical laboratory medicine.
Sepsis is one of the deadliest killers in US hospitals. That is why there is interest in the recent action by the FDA to grant marketing authorization for an AI-powered sepsis detection software through the agency’s De Novo Classification Request. The DNCR “provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device,” the FDA’s website states.
Unlike a single analyte assay that is run in a clinical laboratory, Prenosis’ AI/ML software uses 22 diagnostic and predictive parameters, along with ML algorithms, to analyze data and produce a clinically actionable answer on sepsis.
It is important for clinical laboratory managers and pathologists to recognize that this diagnostic approach to sepsis brings together a number of data points commonly found in a patient’s electronic health record (EHR), some of which the lab generated and others the lab did not generate.
“Sepsis is a serious and sometimes deadly complication. Technologies developed to help prevent this condition have the potential to provide a significant benefit to patients,” said Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health, in a statement. “The FDA’s authorization of the Prenosis Sepsis ImmunoScore software establishes specific premarket and post-market requirements for this device type.” Clinical laboratory EHRs contain some of the data points Prenosis’ diagnostic software uses. (Photo copyright: US Food and Drug Administration.)
How it Works
To assist doctors diagnose sepsis, the ImmunoScore software is first integrated into the patient’s hospital EHR. From there, it leverages 22 parameters including:
White blood cell count to produce a score that informs caregivers of the patient’s risk for sepsis within 24 hours, MedTech Dive reported.
Instead of requiring a doctor or nurse to look at each parameter separately, the SaMD tool uses AI “to evaluate all those markers at once”, CNBC noted. It then produces a risk score and four discrete risk stratification categories (low, medium, high, and very high) which correlate to “a patient’s risk of deterioration” represented by:
By sharing these details—a number from one to 100 for each of the 22 diagnostic and predictive parameters—Sepsis ImmunoScore helps doctors determine which will likely contribute most to the patient’s risk for developing sepsis, MedTech Dive reported.
“A lot of clinicians don’t trust AI products for multiple reasons. We are trying very hard to counter that skepticism by making a tool that was validated by the FDA first, and then the second piece is we’re not trying to replace the clinician,” Bobby Reddy Jr., PhD, Prenosis co-founder and CEO, told MedTech Dive.
Big Biobank and Blood Sample Data
Prenosis, which says its goal is the “enabling [of] precision medicine in acute care” developed Sepsis ImmunoScore using the company’s own biobank and a dataset of more than 100,000 blood samples from more than 25,000 patients.
AI algorithms drew on this biological/clinical dataset—the largest in the world for acute care patients suspected of having serious infections, according to Prenosis—to “elucidate patterns in rapid immune response.”
“It does not work without data, and the data started at Carle,” said critical care specialist Karen White, MD, PhD, Carle Foundation Hospital, St. Louis, MO, in the news release. “The project involved a large number of physicians, research staff, and internal medicine residents at Carle who helped recruit patients, collect data, and samples,” she said.
Opportunity for Clinical Laboratories
Sepsis is a life-threatening condition based on an “extreme response to an infection” that affects nearly 1.7 million adults in the US each year and is responsible for 350,000 deaths, according to US Centers for Disease Control and Prevention (CDC) data.
A non-invasive diagnostic tool like Sepsis ImmunoScore will be a boon to emergency physicians and the patients they treat. Now that the FDA has authorized the SaMD diagnostic tool to go to market, it may not be long before physicians can use the information it produces to save lives.
Clinical laboratory managers inspired by the development of Sepsis ImmunoScore may want to look for similar ways they can take certain lab test results and combine them with other data in an EHR to create intelligence that physicians can use to better treat their patients. The way forward in laboratory medicine will be combining lab test results with other relevant sets of data to create clinically actionable intelligence for physicians, patients, and payers.
One goal of these new functions is to streamline physician workflows. However, these new EHRs may interface differently with clinical laboratory information systems
Artificial intelligence (AI) developers are making great contributions in clinical laboratory, pathology, radiology, and other areas of healthcare. Now, Electronic Health Record (EHR) developers are looking into ways to incorporate a new type of AI—called “Generative AI”—into their EHR products to assist physicians with time-consuming and repetitive administrative tasks and help them focus on patient-centered care.
Generative AI uses complex algorithms and statistical models to learn patterns from collected data. It then generates new content, including text, images, and audio/video information.
According to the federal Government Accountability Office (GAO), generative AI “has potential applications across a wide range of fields, including education, government, medicine, and law” and that “a research hospital is piloting a generative AI program to create responses to patient questions and reduce the administrative workload of healthcare providers.”
Reducing the workload on doctors and other medical personnel is a key goal of the EHR developers.
Generative AI uses deep learning neural networks modeled after the human brain comprised of layers of connected nodes that process data. It employs two neural networks: a generator [generative network] which creates new content, and a discriminator [discriminative network] which evaluates the quality of that content.
The collected information is entered into the network where each individual node processes the data and passes it on to the next layer. The last layer in the process produces the final output.
Many EHR companies are working toward adding generative AI into their platforms, including:
As our sister publication The Dark Report points out in its December 26 “Top 10 Biggest Lab Stories for 2023,” almost every product or service presented to a clinical laboratory or pathology group will soon include an AI-powered solution.
“We believe that generative AI has the potential of being a personal assistant for every doctor, and that’s what we’re working on,” Girish Navani (above), co-founder and CEO of eClinicalWorks, told EHRIntelligence. “It could save hours. You capture the essence of the entire conversation without touching a keyboard. It is transformational in how it works and how well it presents the information back to the provider.” Clinical laboratory information systems may also benefit from connecting with generative AI-based EHRs. (Photo copyright: eClinicalWorks.)
Generative AI Can Help with Physician Burnout
One of the beneficial features of generative AI is that it has the ability to “listen” to a doctor’s conversation with a patient while recording it and then produce clinical notes. The physician can then review, edit, and approve those notes to enter into the patient’s EHR record, thus streamlining administrative workflows.
“The clinician or support team essentially has to take all of the data points that they’ve got in their head and turn that into a narrative human response,” Phil Lindemann, Vice President of Data and Analytics at Epic, told EHRIntelligence. “Generative AI can draft a response that the clinician can then review, make changes as necessary, and then send to the patient.”
By streamlining and reducing workloads, EHRs that incorporate generative AI may help reduce physician burnout, which has been increasing since the COVID-19 pandemic.
“Language models have a huge potential in impacting almost every workflow,” Girish Navani, co-founder and CEO of eClinicalWorks, told EHRIntelligence. “Whether it’s reading information and summarizing it or creating the right type of contextual response, language models can help reduce cognitive load.”
Generative AI can also translate information into many different languages.
“Health systems spend a lot of time trying to make patient education and different things available in certain languages, but they’ll never have every language possible,” Lindemann said. “This technology can take human language, translate it at any reading level in any language, and have it understandable.”
MEDITECH is working on a generative AI project to simplify clinical documentation with an emphasis on hospital discharge summaries that can be very laborious and time-consuming for clinicians.
“Providers are asked to go in and review previous notes and results and try to bring that all together,” Helen Waters, Executive Vice President and COO of MEDITECH, told EHRIntelligence. “Generative AI can help auto-populate the discharge note by bringing in the discrete information that would be most relevant to substantiate that narrative and enable time savings for those clinicians.”
Many Applications for Generative AI in Healthcare
According to technology consulting and solutions firm XenonStack, generative AI has many potential applications in healthcare including:
The technology is currently in its early stages and does present challenges, such as lack of interpretability, the need for large datasets and more transparency, and ethical concerns, all of which will need to be addressed.
“We see it as a translation tool,” Lindemann told EHRIntelligence. “It’s not a panacea, but there’s going to be really valuable use cases, and the sooner the community can agree on that, the more useful the technology’s going to be.”
Since generative AI can be used to automate manual work processes, clinical laboratories and anatomic pathology groups should be alert to opportunities to interface their LISs with referring physicians’ EHRs. Such interfaces may enable the use of the generative AI functions to automate manual processes in both the doctors’ offices and the labs.
Research in the UK and US into how rapid WGS can prevent deaths and improve outcomes for kids with rare genetic diseases may lead to more genetic testing based in local clinical laboratories
Genetic scientists with the National Health Service (NHS) in England have embarked on an ambitious plan to offer rapid whole genome sequencing (rWGS) for children and babies with serious illnesses, as part of a larger initiative to embrace genomic medicine in the United Kingdom (UK).
The NHS estimates that the plan will benefit more than 1,000 children and babies each year, including newborns with rare diseases such as cancer, as well as kids placed in intensive care after being admitted to hospitals. Instead of waiting weeks for results from conventional tests, clinicians will be able to administer a simple blood test and get results within days, the NHS said in a press release.
The press release notes that about 75% of rare genetic diseases appear during childhood “and are responsible for almost a third of neonatal intensive care deaths.”
Here in the United States, pathologists and clinical laboratory managers should see this development as a progressive step toward expanding access to genetic tests and whole genome sequencing services. The UK is looking at this service as a nationwide service. By contrast, given the size of the population and geography of the United States, as this line of medical laboratory testing expands in the US, it will probably be centered in select regional centers of excellence.
“This strategy sets out how more people will be empowered to take preventative action following risk-based predictions, receive life-changing diagnoses, and get the support needed to live with genomically-informed diagnoses alongside improved access to cutting-edge precision [medicine] treatments. It also outlines how the NHS will accelerate future high-quality genomic innovation that can be adopted and spread across the country, leading to positive impacts for current and future generations,” the NHS wrote.
“This global first is an incredible moment for the NHS and will be revolutionary in helping us to rapidly diagnose the illnesses of thousands of seriously ill children and babies—saving countless lives in the years to come,” said NHS chief executive Amanda Pritchard (above) in a press release announcing the program. (Photo copyright: Hospital Times.)
New Rapid Whole Genome Sequencing Service
The NHS announced the plan following a series of trials last year. In one trial, a five-day old infant was admitted to a hospital in Cheltenham, Gloucester, with potentially deadly levels of ammonia in his blood. Whole genome sequencing revealed that changes in the CPS1 gene were preventing his body from breaking down nitrogen, which led to the spike in ammonia. He was given life-saving medication in advance of a liver transplant that doctors believed would cure the condition. Without the rapid genetic test, doctors likely would have performed an invasive liver biopsy.
Using a simple blood test, the new newborn genetic screening service in England is expected to benefit more than 1,000 critically ill infants each year, potentially saving their lives. “The rapid whole genome testing service will transform how rare genetic conditions are diagnosed,” explained Emma Baple, PhD, Professor of Genomic Medicine at University of Exeter Medical School and leader of the National Rapid Whole Genome Sequencing Service in the press release. “We know that with prompt and accurate diagnosis, conditions could be cured or better managed with the right clinical care, which would be life-altering—and potentially life-saving—for so many seriously unwell babies and children,” Precision Medicine Institute reported.
According to The Guardian, test results will be available in two to seven days.
Along with the new rWGS testing service, the NHS announced a five-year plan to implement genomic medicine more broadly. The provisions include establishment of an ethics advisory board, more training for NHS personnel, and an expansion of genomic testing within the existing NHS diagnostic infrastructure. The latter could include using NHS Community Diagnostics centers to collect blood samples from family members to test for inherited diseases.
UK’s Longtime Interest in Whole Genome Sequencing
The UK government has long been interested in the potential role of WGS for delivering better outcomes for patients with genetic diseases, The Guardian reported.
In 2013, the government launched the 100,000 Genomes Project to examine the usefulness of the technology. In November 2021, investigators with the project reported the results of a large pilot study in which they analyzed the genomes of 4,660 individuals with rare diseases. The study, published in the New England Journal of Medicine (NEJM) titled, “100,000 Genomes Pilot on Rare-Disease Diagnosis in Health Care—Preliminary Report,” found “a substantial increase in yield of genomic diagnoses made in patients with the use of genome sequencing across a broad spectrum of rare disease.”
The study’s findings suggest that use of WGS “could save the NHS millions of pounds,” The Guardian reported.
Whole Genome Sequencing System for Newborns in the US
“This NBS-rWGS [newborn screening by rapid whole genome sequencing] system is designed to complement the existing newborn screening process and has the potential to eliminate the diagnostic and therapeutic odyssey that many children and parents face,” Kingsmore said in a press release. “Currently, only 35 core genetic disorders are recommended for newborn screening in the United States, but there are more than 7,200 known genetic diseases. Outcomes remain poor for newborns with a genetic disease because of the limited number of recommended screenings. With NBS-rWGS, we can more quickly expand that number and therefore potentially improve outcomes through precision medicine.”
A more recent 2023 study which examined 112 infant deaths at Rady Children’s Hospital found that 40% of the babies had genetic diseases. In seven infants, genetic diseases were identified post-mortem, and in five of them “death might have been avoided had rapid, diagnostic WGS been performed at time of symptom onset or regional intensive care unit admission,” the authors wrote.
“Prior etiologic studies of infant mortality are generally retrospective, based on electronic health record and death certificate review, and without genome information, leading to underdiagnosis of genetic diseases,” said Christina Chambers, PhD, co-author of the study, in a press release. “In fact, prior studies show at least 30% of death certificates have inaccuracies. By implementing broad use of genome sequencing in newborns we might substantially reduce infant mortality.”
Pioneering work with whole genome sequencing for newborns, such as that being conducted by the clinical laboratory and genetic teams at Rady Children’s Hospital and the UK’s NHS, could allow doctors to make timely interventions for our most vulnerable patients.
