News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Australia’s NSW Health Chooses Epic for its Statewide Patient EHR

Five clinical laboratory information systems are part of the transition that will create a single statewide EMR for all New South Wales patients

In a massive project, Australia’s New South Wales Ministry of Health (NSW Health) has selected health information system developer Epic to unify its five pathology laboratory information management systems (LIMS), nine electronic medical record systems (EMR), and six patient administration systems (PAS) into a statewide single digital patient record (SDPR).

According to ITnews, providers in New South Wales currently use LIMS systems by Citadel Health and Integrated Software Solutions OMNI-Lab, EMR systems by Oracle Cerner and Orion Health, and patient administration systems from Oracle Cerner and DXC.

“The SDPR will consolidate geographically fragmented EMR, PAS, and LIMS systems to create a detailed lifelong patient record and deliver cost savings,” NSW Health said in a news release.

NSW Health is the largest public health system in Australia with more than 220 public hospitals, 16 Local Health Districts, and three Specialty Networks. NSW Health Pathology operates more than 60 pathology laboratories (clinical laboratories in the US) and has 150 patient service centers.

Andrew Montague

“While this initiative will provide untold benefits to all the patients of NSW, we are excited about its potential for improving the health outcomes of our regional patients,” said Andrew Montague (above), former Chief Executive, Central Coast Local Health District in a press release. “By enabling greater collaboration across all local health districts and specialty health networks, the Single Digital Patient Record will provide clinicians with even better tools to keep the patient at the center of everything we do.” This project is more market evidence of the trend to bring clinical laboratory test results from multiple lab sites into a single data repository. (Photo copyright: Coast Community News.)

Cloud-based Realtime Access to Patient Records

Australia has a population of about 26 million and New South Wales, a state on the east coast, is home to more than eight million people. Though the scale of healthcare in Australia is much smaller than in the US, this is still a major project to pull patient data together from all the NSW hospitals, physicians’ offices, and other healthcare providers such as clinical laboratories and pathology practices.

With the change, NSW clinicians will benefit from a cloud–based system offering up real-time access to patients’ medical records, NSW Health Pathology Chief Executive Tracey McCosker told ITnews.

“Patients and our busy staff will benefit from clinical insights gained from the capture of important new data. Our work in pathology is vital to the diagnostic process and developing a statewide laboratory information management system will ensure we provide the best possible services,” McCosker told ITnews.

The KLAS Research report, “US Hospital Market Share 2022,” states that Epic, located in Verona, Wisconsin, has the largest US electronic health record (EHR) market share, Healthgrades noted. According to KLAS:

NSW Health’s decision to engage Epic came after a process involving 350 clinicians, scientists, and technical experts, Zoran Bolevich, MD, Chief Executive of eHealth NSW and NSW Health’s Chief Information Officer, told ITnews.  

NSW Health’s Goal for Statewide Digital Patient Record

It was in December 2020 when NSW Health announced its plan to create the SDPR. 

“Our vision is to be able to provide a single, holistic, statewide view of every patient—and for that information to be readily accessible to anyone involved in the patient’s care,” Bolevich said in the news release.

The SDPR, according to NSW Health, will address the following:    

Challenges:

  • Current systems not connected statewide.
  • Inaccessible patient data.
  • Duplicative data collection.
  • Gaps in decision-making.

Goals:

  • Improve health outcomes.
  • Create patient centricity.
  • Leverage insights.

NSW’s government has already invested more than $106 million in the SDPR, Healthcare IT News reported.

Other Large EHR Rollouts

NSW Health is not the only large organization to take on such an ambitious project of creating a large-scale digital patient record. And not always to a successful conclusion.

The US Department of Veterans Affairs (VA)—also intent on EHR modernization—recently announced it is suspending roll-out of the Oracle Cerner EHR at VA centers until June 2023 to address technical issues affecting appointments, referrals, and test results.

Four VA centers in Washington, Oregon, and Ohio already went live with the system in 2022.

“We are delaying all future deployments of the new EHR while we fully assess performance and address every concern. Veterans and clinicians deserve a seamless, modernized health record system, and we will not rest until they get it,” said Deputy Secretary of Veterans Affairs Donald Remy, JD, in a news release.

For its part, Oracle Cerner wrote federal lawmakers noting the importance of continuing the project, which will move the VA away from its former VistA health information system. 

“Modernization requires change and some short-term pain for the long-term benefits of a modern technology infrastructure,” noted Oracle Cerner Executive Vice President Ken Glueck in the letter, Becker’s Health IT reported. “A modernization project of this scale and scope necessarily involves time to untangle the decades of customized processes established in support of VistA, which inevitably involves challenges.”

NSW Health’s goal is to build a single repository of health information—including lab test results from multiple clinical laboratory sites. When finished NSW Health expects that sharing patient data will contribute to producing better healthcare outcomes.

However, the VA’s experience—and several other similar attempts at large-scale electronic patient record installations—suggest the work ahead will not be easy. But for NSW Health, it may be worth the effort.   

—Donna Marie Pocius

Related Information:

NSW Health Taps Epic for Statewide, Single Digital Patient Record

Single Digital Patient Record Set to Deliver Vastly Improved Patient Experience

NSW Health to Partner with Epic in the Next Step Towards its Digital Healthcare System

US Hospital Market Share 2022: Strong Purchasing Energy across Large, Small, and Standalone Hospitals

EHR Market Share 2021: 10 Things to Know About Major Players Epic, Cerner, Meditech and Allscripts

Single Digital Patient Record (SDPR)

New South Wales Invests $106 Million in Single EMR System

OIG Report Finds Management Deficiencies at VA Hospital Kept Alcohol-Impaired Pathologist on the Job

VA Office of Inspector General recommends changes in management processes after doctor is sentenced to long federal prison term

In a compelling report, the US Department of Veterans Affairs (VA) Office of Inspector General (OIG) found that a host of management failures and “deficiencies in the facility’s quality management processes” at an Arkansas VA hospital contributed to “thousands of diagnostic errors” throughout the tenure of the facility’s Chief of Pathology and Laboratory Medical Services Robert Morris Levy, MD.

Levy oversaw pathology and medical laboratory services at the Fayetteville VA Medical Center from 2005 until 2018. The hospital is part of the Veterans Health Care System of the Ozarks.

The OIG’s report, titled, “Pathology Oversight Failures at the Veterans Health Care System of the Ozarks in Fayetteville, Arkansas,” pointed to “deficiencies in quality management processes” and a “failure to foster a culture of accountability,” which allowed Levy to practice at the facility despite staff concerns that he appeared to be impaired by alcohol while on duty.

“Any one of these breakdowns could cause harmful results,” the report states. “Occurring together and over an extended period of time, the consequences were devastating, tragic, and deadly.”

The OIG report’s findings on how hospital and laboratory administrators dealt with Levy over the years of his employment at the Fayetteville VA Medical Center demonstrate why clinical and pathology lab leaders need to be constantly vigilant in how various quality and compliance procedures are administered in their laboratories. When people and processes are not meeting acceptable standards, it is patients who are at risk of being harmed.

In January, the federal court in Arkansas sentenced Levy to “240 months in federal prison, followed by three years of supervised release and ordered [him] to pay $497,745.70 in restitution for one count each of mail fraud and involuntary manslaughter,” according to court documents.

Robert Morris Levy, MD

In its coverage of the federal case against Robert Morris Levy, MD (above in a jailhouse photo), former Chief of Pathology and Laboratory Medical Services at the Fayetteville VA Medical Center, The Washington Post wrote, “Levy’s supervisors failed to heed early warnings that he was endangering patients and then were slow to act, according to internal VA documents, court filings, and interviews with 20 congressional officials, veterans and current and former VA employees.” Clinical laboratory managers and hospital pathologists would be well advised to study the VA’s conclusions in its recent report. (Photo copyright: The Washington Post.)

VA Pathologist Received Multiple Suspensions, then Termination

Following his removal in April 2018, the OIG assembled a team of pathologists to review nearly 34,000 cases interpreted by Levy since he began working at the VA hospital. They identified more than 3,000 errors, of which 589 were classified as “major diagnostic discrepancies” potentially having a negative impact on patient care.

Of the 589, 34 were deemed serious enough to require institutional disclosures, defined as a discussion with the patient or the patient’s representative revealing “that an adverse event has occurred during the patient’s care that resulted in or is reasonably expected to result in death or serious injury.”

The OIG report cited at least two deaths likely resulting from misdiagnoses.

Levy’s hospital privileges were initially suspended in March 2016 following a blood alcohol test indicating he was legally intoxicated while at work. He was reinstated about six months later after completing a treatment program and agreeing to submit to random drug testing.

His privileges were suspended again in October 2017 after he showed signs of impairment during a hospital committee meeting. He was terminated in April 2018 after he was arrested for allegedly driving while intoxicated (DWI) during work hours.

Federal Court Indicts Levy on Multiple Counts

Shortly after the OIG team began reviewing Levy’s cases, a separate OIG group launched a criminal investigation. Levy admitted to investigators that he had been an alcoholic for 30 years, the report stated, and that he had “purchased a substance, 2-methyl-2-butanol (2M2B), online that could be ingested, was similar to alcohol but more potent, and was not detectable using routine drug and alcohol testing methods.”

Citing the federal indictment, the OIG report noted that Levy passed 42 drug and alcohol tests following his reinstatement at the hospital in 2016.

In August 2019, federal authorities charged Levy with three counts of involuntary manslaughter along with multiple counts of wire fraud, mail fraud, and making false statements. The wire and mail fraud charges were related to his 2M2B purchases.

Levy pleaded guilty in June 2020 and was sentenced on January 22, 2021. In addition to the 20-year prison term, he was ordered to pay approximately $498,000 in restitution to VA. The OIG report noted that Levy has appealed the sentence.

In “Pathologist, Neurosurgeon, and Critical Care Specialist Face Criminal Charges in the Deaths of Dozens of Patients,” which covered the Levy case, Dark Daily asked, “At what point might criminal investigators hold medical laboratories accountable for not notifying authorities about lab test utilization patterns by physicians who could be reasonably understood to be putting their patients at risk of harm?”

And in “Arkansas Pathologist Faces Three Manslaughter Charges,” Dark Daily’s sister publication, The Dark Report, noted that “The outcome of [the Levy] case could be a precedent that gives other prosecutors the confidence that they can file criminal charges in cases where evidence shows that a pathologist’s actions contributed to diagnostic errors that directly contributed to the death of one or more patients.”

Michael J. Missal

“This sentence should send a strong message that those who abuse their positions of trust in caring for veterans will be held accountable,” said VA Inspector General Michael J. Missal in a federal Department of Justice (DOJ) press release. “Our thoughts are with all those harmed by Dr. Levy’s actions, and we hope they find some small measure of comfort from what happened here today.” (Photo copyright: Military Times.)

OIG Finds Numerous ‘Deficiencies in Quality Management’

In its report, OIG found deficiencies in quality management going back to Levy’s original appointment as Pathology and Laboratory Medical Services Chief.

He was initially hired in September 2005 as a locum tenens (temporary) provider and appointed as full-time service chief a month later. This was despite a DWI conviction from 1996 and a stay of only eight months with his previous employer.

Neither would have barred the doctor as a potential candidate; however, the OIG report states, “the OIG is concerned that a rigorous process was not in place to better evaluate his clinical competency at the time he was hired.”

And that was just the beginning.

In his role as service chief, Levy was responsible for the Path and Lab quality management program with assistance from a subordinate staff pathologist, “which made the process susceptible to subversion,” the report states.

The VHA requires a second pathologist to review certain findings, such as diagnosis of a new cancer malignancy. But in some cases, “it was determined that Dr. Levy was entering concurrence statements into some patients’ electronic health records (EHR) when a second pathologist had not agreed with the interpretation or diagnosis,” the OIG report states.

In addition, second reads sometimes “were communicated by sticky notes, which provided Dr. Levy the opportunity to alter or ignore the results,” the OIG reported.

Inherent Conflict of Interest, Fear of Reprisals, and OIG Recommendations

The periodic privileging process, which grants ongoing hospital privileges, was based in part on a “10% peer review” conducted by the staff pathologist. “The involvement of a subordinate in the peer review process of a supervisor creates an inherent conflict of interest,” the OIG report stated. And in some cases, appraisals of the doctor’s competence came from non-pathologists.

The OIG report suggested that the Veteran’s Health Administration (VHA) re-examine its guidance on the peer review, which requires cases to be randomly selected. Instead, the report suggests that targeting specific kinds of cases, such as those with higher risk of interpretation error, could be more effective in analyzing a pathologist’s performance.

The OIG report also noted failures in dealing with the doctor’s impairment and fostering a “culture of accountability.” Hospital staff, apparently, reported signs of impairment as early as 2014, including incidents when the doctor smelled of alcohol and displayed hand tremors. But hospital leadership failed to “vigorously address allegations of impairment,” the OIG report states. And in interviews with the OIG, some staffers expressed fear of reprisal if they reported what they saw.

The OIG report offers 10 recommendations to the VA, including practices related to hiring processes, the 10% peer review, and alcohol and drug testing. It makes two additional recommendations to the director of the Ozarks VA health system: one related to the credentialing processes and the other aimed at ensuring staff and patients can report concerns without fear of reprisal.

Clinical laboratory managers and hospital pathologists may want to review these recommendations and consider the value of applying them in their own practices.

—Stephen Beale

Related Information

Pathology Oversight Failures at the Veterans Health Care System of the Ozarks in Fayetteville, Arkansas

VA Hospital Allowed Alcoholic Pathologist to Go Unchallenged, Resulting in Patient Deaths: Watchdog

Convicted VA Pathologist Oversaw Himself, Federal Study Concludes

Fayetteville Doctor Sentenced to 20 Years in Federal Prison for Mail Fraud and Involuntary Manslaughter

Ex-VA Doctor Who Misdiagnosed Patient Sentenced to Prison

Fayetteville Doctor Arrested on Charges of Wire Fraud, Mail Fraud, Making False Statements, and Involuntary Manslaughter

Pathologist, Neurosurgeon, and Critical Care Specialist Face Criminal Charges in the Deaths of Dozens of Patients

Arkansas Pathologist Faces Three Manslaughter Charges

‘There’s an App for That’ is Becoming the Norm in Healthcare as Smartphones Provide Access to Patient Medical Records and Clinical Laboratory Test Results

Amazon’s app-based employee healthcare service could be first step toward retailer becoming a disruptive force in healthcare; federal VA develops its own mHealth apps

More consumers are using smartphone applications (apps) to manage different aspects of their healthcare. That fact should put clinical laboratories and anatomic pathology groups on the alert, because a passive “wait and see” strategy for making relevant services and lab test information available via mobile apps could cause patients to choose other labs that do offer such services.

Patient use of apps to manage healthcare is an important trend. In January, Dark Daily covered online retail giant Amazon’s move to position itself as a leader in smartphone app-based healthcare with its launch of Amazon Care, a virtual medical clinic and homecare services program. At that time, the program was being piloted for Seattle-based employees and their families only. Since then, it has been expanded to include eligible Amazon employees throughout Washington State.

Mobile health (mHealth) apps are giving healthcare providers rapid access to patient information. And healthcare consumers are increasingly turning to their mobile devices for 24/7 access to medical records, clinical laboratory test results, management of chronic conditions, and quick appointment scheduling and prescription refills.

Thus, hearing ‘There’s an app for that’ has become part of patients’ expectations for access to quality, affordable healthcare.

For clinical laboratory managers, this steady shift toward mHealth-based care means accommodating patients who want to use mobile apps to access lab test results and on-demand lab data to monitor their health or gain advice from providers about symptoms and health issues.

Amazon, VA, and EMS Develop Their Own mHealth Apps

The Amazon Care app can be freely downloaded from Apple’s App Store and Google Play. With it, eligible employees and family members can:

  • Communicate with an advice nurse;
  • Launch an in-app video visit with a doctor or nurse practitioner for advice, diagnoses, treatment, or referrals;
  • Request a mobile care nurse for in-home or in-office visits;
  • Receive prescriptions through courier delivery.

The combination telehealth, in-person care program, mobile medical service includes dispatching nurses to homes or workplaces who can provide “physical assessments, vaccines or common [clinical laboratory] tests.”

Glen Tullman, Executive Chairman of Livongo
“Amazon is a company that is experimenting a lot with a variety of opportunities in healthcare,” Glen Tullman (above), Executive Chairman of Livongo, a healthcare company specializing in treating diabetes, and an Amazon partner company, told CNBC. “It’s one to watch.” (Photo copyright: CNBC.)

However, the US federal Department of Veterans Affairs (VA) also is becoming a major player in the mHealth space with the development of its own mobile app—VA Launchpad—which serves as a portal to a range of medical services.

Veterans can access five categories of apps that allow them to manage their health, communicate with their healthcare team, share health information, and use mental health and personal improvement tools.

Neil C. Evans, MD, Chief Officer in the VA Office of Connected Care
“The VA was an early adopter of digital health tools and remains a leader within US healthcare in leveraging technology to enhance patient engagement,” Neil C. Evans, MD (above), Chief Officer in the VA Office of Connected Care, told Healthcare IT News. “These digital tools are allowing veterans to more actively understand their health data, to better communicate with VA clinical teams, and to engage more productively as they navigate their individual health journeys,” Evans added. (Photo copyright: Department of Veterans’ Affairs.)

mHealthIntelligence reported that mobile health tools also are enabling first responders to improve emergency patient care. At King’s Daughters Medical Center in Brookhaven, Miss., emergency medical technicians (EMTs) are using a group of mHealth apps from DrFirst called Backline to gain real-time access to patients’ HIPAA-compliant medication histories, share clinical data, and gain critical information about patients prior to arriving on the scene.

Using Backline, EMTs can scan the barcode on a patient’s driver’s license to access six months’ worth of medication history.

“In the past, we could only get information from [patients] who are awake or are willing to give us that information,” Lee Robbins, Director of Emergency Medical Services at King’s Daughters Medical Center in Brookhaven, Miss., told mHealthIntelligence. “Knowing this information gives us a much better chance at a good outcome.”

Smartphone App Detects Opioid Overdose

The opioid crisis remains one of the US’ greatest health challenges. The federal Centers for Disease Control and Prevention (CDC) reported 47,600 opioid-related deaths in 2017, and the problem has only gotten worse since then.

To curtail these tragic deaths, University of Washington (UW) researchers developed a smartphone app called Second Chance, that they believe can save lives by quickly diagnosing when an opioid overdose has occurred.

The app uses sonar to monitor an opioid user’s breathing rate and, according to a UW press release, can detect overdose-related symptoms about 90% of the time from up to three feet away. The app then contacts the user’s healthcare provider or emergency services.

The UW researchers are applying for US Food and Drug Administration (FDA) clearance. They published their findings in the journal Science Translational Medicine.

While Demand for mHealth Apps Grows, Concern over Privacy and Security also Increases  

According to mobile data and analytics company App Annie, global downloads of medical apps grew to more than 400 million in 2018, up 15% from two years earlier.

“As with mobile banking, consumers are showing they trust mobile apps with their most sensitive information and are willing to leverage them to replace tasks traditionally fulfilled in-person, such as going into a bank branch or, in the case of medical apps, to a doctor’s office,” App Annie’s website states.

However, the proliferation of mHealth apps has raised privacy and safety concerns as well. While the FDA does regulate some mobile health software functions, it does not ensure an mHealth app’s accuracy or reliability.

In his article, “Dangers of Defective Mobile Health Apps and Devices,” published on the Verywell Health website, Kevin Hwang, MD, MPH, physician, researcher, and Medical Director of UT Physicians General Internal Medicine Center in the Texas Medical Center at the University of Texas Medical School at Houston, points out that “most mHealth apps have not been tested in a rigorous manner.”

Fierce Healthcarereported that federal lawmakers are worried veterans who use the VA’s 47 mHealth apps could find their sensitive healthcare information shared or sold by third-party companies. In fiscal year 2018, veterans participated in more than one million video telehealth visits, a VA press release reported.

US Rep. Susie Lee, D-Nevada, Chairperson of the House Veterans’ Affairs Subcommittee on Technology Modernization, told Fierce Healthcare, “As we assess the data landscape at the VA and the larger health IT space, we need to look at where protections exist or don’t exist and whether we need more guardrails.”

What does all this mean for clinical laboratories? Well, lab managers will want to keep an eye on the growing demand from consumers who want direct access to laboratory test data and appointment scheduling through mHealth apps. And, also be aware of HIPAA regulations concerning the sharing of that information.

—Andrea Downing Peck

Related Information:

How Amazon is Using IoT to Care for Its Employees

Amazon Launches Amazon Care, a Virtual Medical Clinic for Employees

VA Seeing Substantial Growth in Telehealth, Key Patient Engagement Tools

VA Releases Launchpad App to Streamline Healthcare Access for Veterans and Caregivers

Drug Overdose Deaths

Smartphone App Can Detect Opioid Overdoes Using Sonar

VA Exceeds More than One Million Video Telehealth Visits in FY2018

Medical Apps Transform How Patients Receive Medical Care

Dangers of Defective Mobile Health Apps and Devices

mHealth Tools Help Providers Access Data When They Most Need it

Here’s How Amazon Employees Get Health Care Through a New App—A Glimpse of the Future of Medicine

VA Launches New mHealth App to Consolidate Vets’ Access to Resources

The VA Recommends Apps for PTSD and Pain Management. It’s Led to New Veteran Privacy Concerns

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