Compilation shows US Veterans Administration spent the most at $16B
Clinical laboratory leaders and pathologists will be interested in which hospital systems are making the largest investments in electronic health record (EHR) technologies. Especially considering laboratory information systems (LIS) must interface with these platforms and require extensive reworking when hospitals change their EHRs. For example, hospitals moving to the Epic Systems EHR often require their laboratories to implement the Epic Beaker LIS as well.
According to information sourced by Becker’s Hospital Review, the top 16 hospital systems each spent $500 million or more on EHRs, adding, however, that the information is “not an exhaustive list.”
Number three on the list is Kaiser Permanente which operates multiple hospitals within its nine healthcare networks across the United States serving 12.5 million members. For that reason, its total investment in EHR technology represents a much larger number of hospitals than the other health systems on the list.
Of the 16 providers on the list, 12 installed EHRs provided by Epic Systems of Verona, Wis. Four of the providers implemented EHRs from Oracle Health (formerly Cerner), North Kansas City, Mo., and Meditech of Westwood, Mass.
“Looking forward, there are many advantages in terms of investing in the future and how we will be aligned with technologies including digital and AI applications,” said pathologist Angelique W. Levi, MD (above), vice chair and director of pathology reference services at Yale School of Medicine, in a news release following a site visit to Geisinger Diagnostic Medicine Institute in Danville, Pa., to see Epic Beaker in operation at Geisinger’s clinical laboratory. “But what we gain immediately—having all the patient information accessible in one place in a linked and integrated fashion—is very important.” (Photo copyright: Yale School of Medicine.)
Provider, EHR, Investment
Becker’s list below shows the total amount invested by the 16 healthcare systems was approximately $38.32 billion. The average EHR implementation cost is $2.39 billion for a large healthcare provider.
Becker’s stated they assembled this list from public sources and that there may be other EHR/hospital contracts with a total cost that also would make the list. It is not common to see a list of what hospitals actually spend to acquire and deploy a new EHR.
Epic added 153 hospitals to its client base in 2023. Epic’s EHR competitors—Oracle and Meditech—both experienced declines in client retention rate, Healthcare IT News reported based on the KLAS data.
“Both current and prospective large organization customers are drawn to Epic because they see the vendor as a consistently high performer that provides strong healthcare IT [information technology], quality relationships, and the opportunity to streamline workflows and improve clinicians’ satisfaction,” Healthcare IT News said of the KLAS report’s findings.
In a blog post, authors of the KLAS report explained that in 2023 Oracle added specialty hospital clients and Meditech “saw several new sales” which included healthcare systems and independent providers.
In the next few years, the industry is “ripe for disruption. Another vendor could come in and turn everything on its head,” the KLAS blog article concluded. “Even those who choose Epic want to have more competitive options to choose from.”
Preparing for an LIS Change
Clinical laboratory leaders who may be transitioning their LIS during a new EHR installation may learn from colleagues who completed such an implementation.
Angelique Levi, MD, vice chair and director of pathology reference services at Yale School of Medicine, who was part of the pathology team, noted that one challenge for labs is addressing “information that’s from many different places when we’re talking about cancer care, prognostic testing, and diagnostics.
“It’s become much more complicated to manage all those data points,” she continued. “Without being on an integrated and aligned system, you’re getting pieces of information from different places, but not the ability to have linked and integrated reports in one spot.”
EHR implementations are among the most labor-intensive, expensive projects undertaken by hospitals. Therefore, it is crucial that clinical laboratory and pathology leaders research and learn why an EHR (and possibly LIS) change is needed, what is expected, and when results will be received.
Clinical laboratories and anatomic pathology groups should consider these cyberattacks on major healthcare entities as reminders that they should tighten their cybersecurity protections
Hackers continue to gain access to public health records—including clinical laboratory testing data—putting thousands of patients’ protected health information (PHI) at risk of being exposed. The latest important healthcare entity to become the victim of a ransomware attack is American Associated Pharmacies (AAP). According to The Register, AAP announced a ransomware operation called Embargo had stolen over 1.4 terabytes (TB) of data, encrypted those files, and demanded $1.3 million to decrypt the data.
Embargo claims that Scottsboro, Ala.-based AAP paid $1.3 million to have its systems restored. They are now demanding an additional $1.3 million to keep the stolen data private, the HIPAA Journal reported, adding, “The attack follows ransomware attacks on Memorial Hospital and Manor, an 80-bed community hospital and 107 long-term care facility in Georgia, and Weiser Memorial Hospital, a critical access hospital in Idaho.”
AAP has not publicly confirmed the ransomware attack, nor has it made an official statement regarding the breach. But it did post an “Important Notice” on its website reporting, “limited ordering capabilities for API Warehouse have been restored at APIRx.com.”
API Warehouse is a subsidiary of AAP that helps subscribers save on brand name and generic prescriptions via wholesale purchasing plans. It oversees more than 2,000 independent pharmacies across the US and has over 2,500 stock keeping units (SKUs) in its inventory.
The message further states “All user passwords associated with both APIRx.com and RxAAP.com have been reset, so existing credentials will no longer be valid to access the sites. Please click ‘forgot password’ on the log in screen and follow the prompts accordingly to reset your password.”
“Embargo seems to have international and multi-sector victims and is not focusing on a specific victim profile. They seem opportunistic,” Mike Hamilton (above), founder and chief information security officer (CISO) of cybersecurity firm Critical Insight, told HealthcareInfoSecurity. “However, as they do have multiple victims in healthcare, and their tooling to disable detection is sophisticated, they should not be discounted. If indeed they operate through affiliates, we can expect others to use their infrastructure and tools, and Embargo may emerge as a top threat to healthcare.” Since 80% of all medical records are made up of clinical laboratory testing data, laboratory patients are particularly vulnerable. (Photo copyright: Critical Insight.)
Embargo on the Hunt for PHI
Due to the large amount of data Embargo stole from the AAP servers, it’s likely the hackers were able to procure medical records and account details from all customers of the pharmacies involved in the attack.
Researchers at ESET, an internet security company, first noticed the ransomware organization known as Embargo in June of this year. In a news release, ESET stated that Embargo used an endpoint detection and response (EDR) killer toolkit to steal AAP’s data.
“Based on its modus operandi, Embargo seems to be a well-resourced group. It sets up its own infrastructure to communicate with victims. Moreover, the group pressures victims into paying by using double extortion: the operators exfiltrate victims’ sensitive data and threaten to publish it on a leak site, in addition to encrypting it,” ESET wrote in a news release.
Embargo recently attacked other organizations within the healthcare industry as well. In November, it claimed responsibility for breaching the security of Memorial Hospital and Manor in Bainbridge, Ga. The cyberattack affected Memorial’s email and electronic medical record (EHR) systems, which caused the facility to pivot to a paper-based system, The Cyber Express reported.
Embargo’s attack on Weiser Memorial Hospital in Weiser, Idaho, involved the theft of approximately 200 gigabytes (GB) of sensitive data and caused a four-week-long outage of its computer systems.
Other Cyberattacks on Healthcare Organizations
Dark Daily has covered many cyberattacks on hospital health systems in multiple ebriefs over the past few years.
Safeguarding patient data is critical, and more healthcare organizations are discovering the hard way that they are vulnerable to hackers. This situation serves as another reminder to clinical laboratory and pathology group managers that they need to be proactive and serious about protecting their information systems, and in upgrading their digital security at regular intervals.
Hackers are working hard to obtain access to protected health information, which puts patients at continuous risk of having their private records stolen.
Clinical laboratories could play a key role in helping users collect their samples correctly, interpret results, and transfer flu test data to their health records
Clinical laboratories may have another opportunity to provide service to their clients and the physicians who treat them. With the success of at-home COVID-19 testing, consumer demand for self-tests is changing and advances in diagnostic technology now make it feasible to make more influenza (flu) tests available for consumers to buy and use at home.
At-home tests for SARS-CoV-2 can be found at pharmacies all across America. But that’s not the case with tests for influenza.
Should self-test flu kits eventually become available and common, clinical laboratories could offer the service of helping consumers understand:
that the test was conducted correctly (specimen collection and analysis),
“Home flu testing would ensure that those who do need and receive antiviral medication for influenza are the ones who need it the most,” and that “we are making our treatment decisions based on data,” infectious disease specialist Christina Yen, MD (above), University of Texas Southwestern Medical Center, told STAT News. At-home flu self-tests could also bring opportunities for clinical laboratories to provide service to healthcare consumers and the physicians who treat them. (Photo copyright: UT Southwestern Medical Center.)
Pros and Cons of Consumers Doing At-home Influenza Testing
According to the federal Centers for Disease Control and Prevention (CDC), COVID-19 and influenza are both upper respiratory illnesses with similar symptoms. So, why don’t we have more at-home flu tests available? Partly because at-home testing is a relatively new phenomenon in modern healthcare.
“It’s really rare, and it’s really new that people are allowed to know about what’s happening inside their body without a physician in the middle,” Harvard epidemiologist Michael Mina, MD, PhD, told STAT News. The article uses the example of at-home pregnancy tests. Despite a prototype for an at-home pregnancy test being created in 1967, it took another decade before an over-the-counter pregnancy test became available to the public.
“The general thinking was, ‘How could a woman possibly know what to do if she found out she was pregnant on her own without a doctor in the room?’ That is a ridiculous concern because women have been doing that for millions of years,” Mina added.
So, why be cautious when it comes to giving patients the option of at-home flu testing?
There are some cons to at-home influenza tests. Average citizens are not clinical laboratory professionals. They might obtain too little sample for an accurate reading or read the results incorrectly. Then, there is the possibility for false-negatives or false-positives.
An at-home test user is not likely to consider the possibility of a false result, however clinicians look at the situation with more nuance. If the patient was still symptomatic or in a high-risk community, the provider could administer a more sensitive medical laboratory test to confirm the previous test results.
“In a Facebook post from mid-November with hundreds of responses, concertgoers compared symptoms and positive test results, many of those from tests taken at home. But those data weren’t added to state public health tallies of COVID’s spread,” STAT News noted.
The larger concern is that samples obtained by at-home self-test users are not submitted for genomic sequencing. This could lead to incomplete data and delay identifying new variants of the coronavirus in communities.
Another barrier to at-home flu testing is that rapid influenza diagnostic testing can be unreliable. In 2009, the rapid influenza tests could only detect the H1N1 influenza virus in a mere 11% of samples, STAT News reported. Because of this, the FDA now requires manufacturers to test their rapid tests against eight different strains that change every year depending upon which strains are prevalent. This could present a problem if individuals use leftover tests from the previous flu season.
Do Pros of At-home Testing Outweigh the Cons?
At-home testing is convenient and makes testing more accessible to patients who may not be able to get to a clinic. Being able to test at home also encourages individuals to take precautions necessary to stop the spread of whichever illness they may have. Given the similarities in symptoms between influenza and COVID-19, people could benefit from having tools at home that correctly identify their illness.
At-home COVID-19 tests are here to stay, and at-home influenza tests may be on the way soon. Clinical laboratories could play an important role in educating the public on the correct handling of these tests.
There was cautious optimism about the ability of Canada’s medical laboratories to innovate in ways that advance patient care, while recognizing the ongoing challenge of adequate lab staffing and budget constraints
TORONTO, ONTARIO, CANADA—This week, more than 150 leaders representing clinical laboratories, anatomic pathology labs, in vitro diagnostics (IVD) companies, and provincial health officials gathered for the first “Canadian Diagnostic Executive Forum” (CDEF) since 2019. It would be apt to say that the speakers objectively addressed all the good, the bad, and the ugly of Canada’s healthcare system and its utilization of medical laboratory testing services.
Over the two days of the conference, speakers and attendees alike concurred that the two biggest issues confronting clinical laboratories in Canada were inadequate staffing and an unpredictable supply chain. There also was agreement that the steady increase in prices, fueled by inflation, is exacerbating continuing cost increases in both lab salaries and lab supplies.
Canada’s Health System Has Several Unique Attributes
Canada’s healthcare system has two unique attributes that differentiate it from those of other nations. First, healthcare is mandated by a federal law, but generally each of Canada’s 13 provinces and territories operates its own health plan. Thus, the health system in each province and territory may cover a different mix of clinical services, therapeutic drugs, and medical procedures. The federal government typically pays 40% of a province’s health costs and the province funds the balance.
Second, it is a fact that 90% of the Canadian population lives within 150 miles of the United States border. Yet there are provinces with large populations that have geography that ranges from the US border to north of the Arctic Circle. These provinces have a major challenge to ensure equal access to healthcare regardless of where their citizens live.
During day one of the conference, several presentations addressed innovations that supported those labs’ efforts to deliver value and timely insights during the COVID-19 pandemic. For example, a lab team in Alberta launched a research study involving SARS-CoV-2 virus surveillance from the earliest days of the outbreak. This study was presented by Mathew Diggle, PhD, FRCPath, Associate Professor and Program Lead for the Public Health Laboratory (ProvLab) Medical-Scientific Staff at Alberta Precision Laboratories in Edmonton, Alberta.
Study Designed to Identify Coinfections with COVID-19
While performing tens of thousands of COVID-19 tests from the onset of the pandemic, and identifying the emergence of variants, the ProvLab team also tracked co-infection involving other respiratory viruses.
“This is one of the largest eCoV [endemic coronavirus] studies performed during the COVID-19 pandemic,” Diggle said. “This broad testing approach helped to address a pivotal diagnostic gap amidst the emergence of a novel pathogen: cross-reactivity with other human coronaviruses that can cause similar clinical presentations. This broad surveillance enabled an investigation of cross-reactivity of a novel pathogen with other respiratory pathogens that can cause similar clinical presentations.
“Fewer than 0.01% of specimens tested positive for both SARS-CoV-2 and an eCoV,” he explained. “This suggested no significant cross-reactivity between SARS-CoV-2 and eCoVs on either test and provided a SARS-CoV-2 negative predictive value over 99% from an eCoV-positive specimen … The data we collected was highly compelling and the conclusion was that there was no coinfection.”
Chairing the two days of presentations at this weeks’ Canadian Diagnostic Executive Forum was Kevin D. Orr (above), Senior Director of Hospital Business at In-Common Laboratories. He also served on the program for this national conference serving clinical laboratories, anatomic pathology labs, and in vitro diagnostics (IVD) companies throughout Canada. This was the first gathering of this conference since 2019. Attendees were enthusiastic about the future of medical laboratory services in Canada, despite lab staffing shortages and rising costs due to inflation. (Photo copyright The Dark Report.)
Clinical Laboratory Regionalization in Quebec
One of Canada’s largest projects to regionalize and harmonize clinical laboratory services is proceeding in Quebec. Leading this effort is Ralph Dadoun, PhD, Project Director for OPTILAB Montreal, which is part of the Ministry of Health and Social Services in Quebec. The ambitious goal for this project is to move the 123 clinical laboratories within the province into 12 clusters. Initial planning was begun in 2013, so this project is in its ninth year of implementation.
During his presentation, Dadoun explained that the work underway in the 12 clusters involves creating common factors in these categories:
Implementation consistent with and respecting ISO-15189 criteria.
Another notable achievement in Quebec is the progress made to implement a common laboratory information system (LIS) within all 12 clusters. The first three laboratory clusters are undergoing their LIS conversions to the same platform during the next 180 days. The expectation is that use of a common LIS across all clinical laboratory sites in Quebec will unlock benefits in a wide spectrum of lab activities and work processes.
The 2022 CDEF featured speakers from most of the provinces. The common themes in these presentations were the shortage of lab personnel across all technical positions, disruptions in lab supplies, and the need to support the usual spectrum of lab testing services even as lab budgets are getting squeezed.
At the same time, there was plenty of optimism. Presentations involving adoption of digital pathology, advances in early disease detection made possible by new diagnostic technologies, and the expansion of precision medicine showed that clinical laboratories in Canada are gaining tools that will allow them to contribute to better patient care while helping reduce the downstream costs of care.
The Canadian Diagnostics Executive Forum is organized by a team from In-Common Laboratories in North York, Toronto, Ontario. Founded in 1967, it is a private, not-for-profit company that works with public hospitals and laboratory medicine providers. Information about CDEF can be found at its website, where several of this year’s presentations will be available for viewing.
Government prosecutors allege destruction of LIS database and point to Holmes’ extravagant lifestyle as evidence of fraud motive
There is a new twist in the federal criminal fraud trial of Elizabeth Holmes, co-founder and former CEO of now defunct clinical laboratory testing company Theranos. Once again, the trial has been delayed. In the meantime, however, dueling court filings between prosecutors and defense lawyers have shed additional light on the allegations against Holmes and co-defendant Ramesh Balwani, the company’s chief operating officer. The revelations will be of interest to medical laboratory leaders.
According to The Mercury News, United States District Judge Edward J. Davila cited the ongoing COVID-19 pandemic in his December 18 ruling that postponed the start of Holmes’ trial to July 13, 2021.
In his ruling, Judge Davila wrote, “The court notes sadly, the impact on our lives is grim. California is in the midst of an unprecedented surge in cases and hospitalizations.”
The judge also noted the prospects for widespread public vaccination in the coming months. “All of this supports continuing the trial [of Holmes] to a time when our community is safer,” he added. “The court recognizes that a continuance of the trial will cause great inconvenience to victims who would like their day in court, as well as Defendant, who wishes a speedy opportunity to defend against the charges. All of these rights are important, but paramount to the court is the safety and health of the community.”
On February 9, Law360 reported that Balwani’s trial was delayed even further, with jury selection now set to begin on January 11, 2022.
Wall Street Journal Exposé of Theranos and its Flawed Clinical Lab Testing
In “Elizabeth Holmes: The Breakthrough of Instant Diagnosis,” the Wall Street Journal (WSJ) put Holmes squarely in the public eye. It could be credibly asserted that the paper’s fawning coverage helped boost her credibility when no one knew who she was. Thus, it is ironic that just two years later it was the WSJ that, in a series of articles, exposed the alleged misrepresentation and fraud committed by Holmes, Balwani, and Theranos.
By 2015, the company had a stock valuation of $9 billion, but it all came crashing down after WSJ investigative journalist John Carreyrou revealed serious problems with the company’s management and technology.
In a public notification from the US Attorney’s Office Northern District of California, the government alleged that Holmes and former Theranos president Balwani promoted the company’s blood-testing technology despite knowing that it was likely to produce unreliable results.
The defendants now face 12 federal felony counts related to wire fraud. They have pleaded not guilty. According to The Mercury News, if found guilty of all charges, “Holmes faces a potential 20-year prison sentence, up to $2.75 million in fines, and possible restitution to investors the government alleges lost more than $700 million.”
Elizabeth Holmes (above), former CEO of now defunct clinical laboratory testing company Theranos, will now stand trial starting in July. Due to risk of infection from the SARS-CoV-2 coronavirus, jurors will be required to wear masks and to socially distance during the trial, CNBC reported. What will be of great interest to clinical laboratories are statements by federal prosecutors that testing data stored on the company’s laboratory information system was destroyed before it could be accessed by investigators, even though it had been subpoenaed months earlier by a federal grand jury. (Photo copyright: Forbes/Yichuan Cao/NurPhoto via Getty Images.)
Missing Clinical Laboratory Data
Though the trial has been delayed, attorneys on both sides have been busy. Last November, after failing to have the charges dismissed, defense attorneys filed a flurry of motions seeking to exclude much of the government’s evidence, The Mercury News reported. This included expert witnesses, testimony about inaccurate test results, and numerous news articles about the company and its tests.
Prosecutors responded to the motions in January, further illuminating their case while providing more fodder for media coverage.
In a January 11 filing [doc-682], the government alleged that a Theranos laboratory information system (LIS) containing patient test results and quality control data was destroyed “on or about August 31, 2018—three months after a federal grand jury issued a subpoena requesting a working copy of this database.” News of the allegation was first reported by The Register, a UK-based IT publication.
Previously, the prosecutors alleged, Theranos, with assistance from an IT contractor, had provided a backup copy of the database to the government but without a password needed for decryption. “All subsequent efforts by the government to access the data on this hard drive have failed,” even with assistance from a computer forensics expert, they wrote.
Then, the original database was permanently destroyed in August when Theranos moved out of its facility in Newark, Calif., the government alleged in its filing. “On or about August 31, 2018—three months after a federal grand jury issued a subpoena requesting a working copy of this database—the LIS was destroyed. The government has never been provided with the complete records contained in the LIS, nor been given the tools, which were available within the database, to search for such critical evidence as all Theranos blood tests with validation errors,” the filing read.
The January 11 filing was in response to a Theranos motion [doc-563] seeking to exclude evidence of “anecdotal test results.”
“The data disappeared. Defendant should be barred from arguing the government’s case is anecdotal when Theranos (and others) destroyed this data,” the prosecutors argued.
Furthermore, prosecutors wrote, “the government’s case is hardly ‘anecdotal.’ The reliability and accuracy problems in Theranos’ clinical lab were well-documented when the Centers for Medicare and Medicaid Services (CMS) investigated the lab, discovered the accuracy and reliability problems, and determined Theranos could not safely administer its tests on patients. Whistleblowers will also testify about Theranos’ accuracy and reliability problems. And patients themselves experienced these problems, receiving incorrect results that affected their treatment and deprived them of the benefit of the purportedly reliable blood tests for which they had paid.”
And Then There’s Her Lifestyle
Prosecutors also claimed in their filing that Holmes’ activities—which included “travel on private jets, stays in luxury hotels, and access to multiple assistants … [who] handled a range of non-business tasks for Defendant, including personal clothes and jewelry shopping, home decorating, food and grocery buying, and other items”—shows that Holmes was “funding an extravagant lifestyle … through company money,” CNBC reported.
And so, the saga of Theranos continues. Will Elizabeth Holmes succeed in her defense? Could a clinical laboratory phoenix bird rise from the ashes of this failed lab test company? Who knows? Probably not. But until there is a resolution, we will keep reporting on the case.
