Data-driven proof supports decision-making that optimizes efficiency and boosts bottom lines in the face of shrinking margins and increased competition
Molecular and esoteric
testing developers continue to make advanced assays and diagnostic
technologies available to medical
laboratories. However, some laboratory senior management and stakeholders
may be reluctant to invest in them even though the market for such testing is
poised for significant growth.
That’s because lab shareholders might view these tests/services
as high-risk and it might not be immediately clear how—with proper
implementation—these services have the potential to improve lab financials and provide
higher-margin services to offset the shrinking margins of common high-volume
tests.
That’s where analytics can help lab managers, who’ve been tasked
with expanding their lab’s menu to include esoteric or molecular testing, justify
the expansion of services or answer questions regarding the lab’s financial
viability to do so.
Being able to answer those questions—such as whether to perform
anatomic
pathology, cytology,
and other advanced testing in-house or outsource, particularly in terms that c-suite
members, shareholders, and other lab decision makers will understand—is
critical to managing expectations and ensuring successful installation of the
new testing.
The approach Michigan-based Spectrum Health took to implement
analytics in their decision-making chain may be instructive.
Spectrum’s experience—through a partnership with LTS Health based in Chicago, IL., and by making use of PinpointBPS, a laboratory performance management system—showcases how laboratories can leverage analytics to not only increase key lab metrics, but do so with minimal risk. All while generating data that will inform critical members of the decision-making chain.
Data Modelling as
Tool for Laboratory Growth
Global Market Insights predicts an 8.5% compound
annual growth rate (CAGR) in molecular diagnostics alone between 2018 to
2024. Clinical laboratories that see automation and staffing as their primary
means for increasing throughput, reducing turnaround times, and optimizing lab
operations, will find Spectrum’s results useful.
Spectrum Health wanted to improve staff performance and
morale while also insourcing specialist testing without adding to the cost base
in their Advanced
Technology Laboratories (ATLs). These labs include—molecular diagnostics, flow cytometry, and cytogenetics—and require
a significant skilled staff investment. As such, Spectrum had questions about latent
capacity and potential costs in relation to their ability to expand service
offerings while maintaining optimal service levels.
They initially implemented PinpointBPS to reinforce the
ideas under consideration:
Optimizing staff schedules to match typical
order flows; and,
Implementation of automated liquid handlers.
Using
analytics, the lab staff was able to both simulate the proposed changes and
obtain quantitative data on how these changes would impact lab financials,
staff efficiency, latent lab capacity, and other key metrics. They could
accomplish all of this without making a single change to existing operations,
staff levels, or lab technologies.
Using analytics and data modelling, Spectrum discovered that
implementing a new staffing model would allow them to achieve several key
objectives—including:
Accounting for workload increases related to next-generation
sequencing (NGS)—using their existing staff.
More importantly, they were able to do so without the
significant hardware investment which they were previously considering.
“Analytics help to highlight areas of improvement through data comparisons and provide an empirical source of truth for determining the best course of action to reach laboratory goals and achieve sustainable, dependable results,” Kim Collison (above), Directory of Laboratory Services at Spectrum Health in Grand Rapids, Mich., told Dark Daily. “These systems also create a monitoring system to further iterate on or adjust improvements. This is accomplished while also gathering data ideal for presenting to the c-suite, shareholders, and other key members of the decision-making chain.” (Photo copyright: LTS Health.)
Much like modeling or
visualization might help to display complex medical data to aid diagnosis,
these systems can model and simulate data related to laboratory operations, integrate
with laboratory
information management systems (LIMS), and simulate
ideas to create quantified data about a range of important aspects including:
Assessment of staffing needs;
Highlighting potential workflow bottlenecks;
Determining latent laboratory capacity; and,
Assessing the value of advanced technology
laboratory investments.
“Everyone is vying for capital dollars,” Linda Flynn, Executive
Consultant at LS Flynn and Associates told Dark Daily. “Good data collected and
organized through data analytics can generate trust and understanding to help
position your proposals to c-suite members for greater success.”
Opportunity to Gain
Critical Knowledge for Your Clinical Laboratories
The webinar will include essential information for clinical laboratories
looking to increase certainty in the decision-making process using facts and
data and provide a solid understanding
for engagement in investment opportunities, c-suite members, and other senior
management and decision makers.
Attendees will also learn from a case study on how Spectrum
Health implemented PinpointBPS to develop an actionable, effective plan to
improve their operations, reduce turnaround times, and improve the value of
their laboratory operations based on facts and data generated within the lab.
Laboratory management, administrative directors, staff, and business
and financial managers of laboratories will want to attend this webinar and the
following Q/A session to obtain information on the impact BI analytics could
hold for their laboratories and how to best implement these new systems for optimal
results.
(To register for this
critical March 27th webinar, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/product/webinar-using-data-analytics-to-optimize-your-investment/.)
Researchers stress the importance of preparing hospital and clinical laboratory information systems before a ‘major failure’ occurs
Medical laboratory information systems (LIS) and similar devices are vulnerable to hacking, according to physicians and computer scientists from the University of California San Diego (UCSD) and the University of California Davis (UCD). They recently completed a study that exposed the vulnerabilities of these systems and revealed how clinical laboratory test results can be manipulated and exploited to put patient lives at risk.
Clinical laboratories hold large volumes of patient protected health information (PHI) in their electronic health record (EHR) systems. And it’s widely understood that medical laboratory test data comprises as much as 80% of patients’ permanent medical records. Therefore, medical laboratory stakeholders and managers could be held accountable should those medical records and databases be violated by computer hackers.
Researchers at the University of California San Diego (UCSD) used a man-in-the-middle attack (illustrated above) to intercept and modify data transmitted from a laboratory information system to an electronic medical record system. Clinical laboratories could be held responsible for such intrusion into patients’ protected health information (PHI) should it be determined that adequate safeguards were not implemented. (Caption and image copyrights: UCSD.)
To demonstrate their findings, the researchers hacked a test system made up of medical laboratory computers, servers, and testing devices. They then performed blood and urinalysis testing, intercepted and altered the normal blood test results to make it appear that the patient suffered from diabetic ketoacidosis (DKA), and then forwarded the modified results to the patient’s electronic medical records.
Such
misdiagnoses could lead physicians to prescribe incorrect medicines and
procedures that could injure or even kill patients.
“As a physician, I aim to educate my colleagues that the implicit trust we place in the technologies and infrastructure we use to care for our patients may be misplaced, and that an awareness of and vigilance for these threat models is critical for the practice of medicine in the 21st century,” Jeffrey Tully, MD (left), stated in the UCSD news release. Christian Dameff, MD (right), agreed, saying, “We are talking about this because we are trying to secure healthcare devices and infrastructure before medical systems experience a major failure. We need to fix this now.” (Photo copyright: University of Arizona News.)
In their paper, the researchers proposed “three viable strategies to ensure increased security and integrity of data in clinical environments, which we hope will be taken into consideration by the healthcare community:
“Secure network deployment: network segmentation, VLANs, and firewall controls: This is the most viable option for legacy systems and healthcare providers with budgetary and operational constraints. By restricting the attack surface of vulnerable devices to Ethernet networks inaccessible to outside influence, the potential for attack is largely mitigated. This, however, requires the intervention and trust of an experienced IT professional. When legacy devices that lack security controls exist in the network environment, isolation of these devices into network segments to minimize exposure is key.
“Proper configuration: In situations where the hospital network cannot be made completely secure through use of network segmentation, the alternative is proper configuration of servers and devices that support encryption. This would mean, for example, ensuring that the interface client, such as Mirth connect, is updated to its most recent version and the communication channels are set up to use encryption.
“Security conscious protocols and ecosystems: Moving forward, device manufacturers, care providers, standards organizations, and policy makers must push to incorporate newer protocols and ecosystems where strong security guarantees are built in, and actively look for these guarantees. One such example is the Fast Healthcare Interoperability Resources (FHIR), a replacement for HL7 which has greater potential for encryption. Without the development of a security conscious culture, healthcare infrastructure will remain vulnerable to malefaction.”
Cyberhacking of patient medical records is a critical issue. According to American Nurse Today, more than 16 million patient records were stolen from US healthcare organizations in 2016. In addition, more than 150 million individuals have had their medical records stolen since 2010. The majority of these thefts were the result of attacks against electronic health records (EHRs).
As
security breaches become more prevalent, it’s imperative that medical
laboratories and anatomic pathology groups take steps to secure their
information systems, testing devices, and patients’ records from cyberhacking. All
healthcare providers should familiarize themselves with cybersecurity methods
and protocols to defend their systems from remote attacks.
A digital camera or smartphone visualizes bioluminescent characteristics of test sample to display levels of Phe in blood, potentially giving medical laboratories a way to support home-based or point of care metabolite tests
Clinical laboratories may soon have a new paper-based finger prick assay that can quickly measure metabolites in blood samples and enable patients who need to monitor certain conditions, such as congenital phenylketonuria, to do so at home.
The test also could be used at the point of care and in remote regions where larger, medical laboratory technology for monitoring metabolites in blood is limited.
Molecular Biosensor
Measures Multiple Metabolites in Blood
“We introduce a fundamentally new mechanism to measure metabolites for blood analysis. Instead of miniaturizing available technology for point-of-care applications, we developed a new molecular tool,” said Qiuliyang Yu, PhD, first author of the paper and scientist at the Department of Chemical Biology at the Max Planck Institute in Heidelberg, in the news release.
In their study, the scientists primarily measured concentration of phenylalanine (Phe) in blood. However, their technology also could be used to monitor glucose and glutamate quantities as well, Medgadetreported.
“The sensor system successfully generated point-of-care
measurements of phenylalanine, glucose, and glutamate. The approach makes any
metabolite that can be oxidized by the cofactor a candidate for quantitative
point of care assays,” the authors wrote in Science.
As shown above, a mixture of the patient’s blood and the reaction buffer is applied onto a paper covered with the immobilized biosensor. The following reaction is detected with a digital camera and analyzed. (Photo and caption copyrights: Max Planck Institute for Medical Research.)
Red is a sign of high Phe concentration and blue low Phe;
The assay takes 15 minutes to perform.
“We have developed light-emitting sensor proteins to report
the concentration of the cofactor NADPH through which many medical metabolites
can be quantified. Because of the bioluminescent nature of the paper, we can
capture the signal—even in blood,” Yu states in the video.
This video demonstrates how the new biosensor works. The process the researchers developed for detecting and measure quantities of Phe in blood involves light-emitting engineered protein and the use of a digital camera or smartphone. During the process a color shift takes place that can be measured to determine the amount of Phe in the blood, Engineering 360 explained. Click here to watch the video. (Video copyright: Max Planck Society/YouTube.)
People Need Faster Test
Answers
More studies are needed before patients use can use the
assay do their own metabolite measurement blood tests. And the scientists say
they plan to simplify and automatize the test.
However, the researchers feel such fast measurements are
needed since many diseases cause changes in blood metabolites. Conventional clinical
laboratory blood tests do help patients to stay on top of their conditions. But
the sooner they can get results, the quicker patients can make necessary
changes in diet and more, the authors note.
“Monitoring metabolites at the point of care could improve
the diagnosis and management of numerous diseases. Yet for most metabolites,
such assays are not available. We introduce semisynthetic, light-emitting
sensor proteins for use in paper-based metabolic assays,” the researchers wrote
in Science.
Medical laboratory leaders may find it interesting to see a POC test with performance similar to tests using sophisticated medical laboratory technology. In fact, Yu makes that point as he stands in front of liquid chromatography-mass spectrometry (LC-MS) equipment in the aforementioned video.
Could the paper-based biosensor one day be preferred by doctors
and patients who need to monitor metabolites? People residing in remote or
rural areas where patient care centers are not so plentiful may appreciate and
need such a tool. And patients may prefer the convenience of doing it themselves
and getting fast answers, rather than visiting a clinical laboratory and
waiting days for results. Either way, these developments are worth following.
Popularity of Medicare Advantage Plans fuels influx of new companies into the marketplace with anticipated enrollment of more than 22.6 million beneficiaries, or more than one-third of Medicare-eligible consumers
Provide care or pursue payment. Until recently those two common healthcare activities were mutually exclusive. But not anymore. Thanks to high-deductible health plans (HDHPs), healthcare providers today—including clinical laboratories and anatomic pathology groups—increasingly must collect full payments rather than deductibles, and directly from patients rather than from insurance companies.
This
trend is forcing doctors to become bill collectors and they’re not happy about
it. Splitting focus between caring for patients and pursuing payments is
causing stress and frustration for those in the medical community.
Collecting Full
Payments from the Insured
Physicians
and hospitals have long had processes for collecting payments from the uninsured.
However, providers must now be prepared to pursue payment from insured patients as well. This includes
clinical laboratories and pathology groups.
“Even
large medical companies with national operations are facing the problem,” Bloomberg notes. “Quest Diagnostics
Inc., the lab-testing giant, said 20% of services billed to patients in the
third quarter of this year went unpaid, costing the company about $80 million
in lost revenue.”
Helping Patients Pay
“It’s harder to collect from the patient than it is from the insurance,” Amy Derick, MD, a dermatologist who owns Derick Dermatology in the Chicago area, told Bloomberg. “If the plans change to a higher deductible, it’s harder to get the patients to pay.”
To assist her patients, Derick has implemented a procedure that
enables them to review cost estimates from their insurance providers in advance.
She finds, though, that collection rates are still slow, especially at the
beginning of the year when health plans renew and deductibles are at their
highest.
Gerald “Ray” Callas, MD, an anesthesiologist in Beaumont, TX, is President of the Texas Society of Anesthesiologists. He has introduced payment options for patients that allow them to pay a portion of their bills upfront or make monthly payments until the bill is paid in full. Nevertheless, he finds that patients still avoid his calls and collection attempts. “If they have to decide if they’re going to pay their rent or the rest of our bill, they’re definitely paying their rent,” he told Bloomberg. “We try to work with the patient, but on the other hand, we can’t do it for free because we still maintain a small business.” (Photo copyright: Texas Medical Association.)
Tarek Fakhouri, MD, a Texas surgeon specializing in skin cancer, said about 10% of his patients request payment plans, delay necessary surgeries until they’ve met their deductibles, or choose alternative treatments. He had to hire an additional staff member to work with patients and their insurers for reimbursement of services.
“It’s
an unnecessary added cost to the healthcare system to have to hire staff just
to sit there on hold with insurance companies to find out what a patient’s
deductible status
is,” he told Bloomberg.
Clinical Laboratories
Also Struggle to Get Paid
It’s not only independent physicians who are
dealing with the consequences of high-deductible health plans. Medical
laboratory companies have been impacted as well.
A 2017 Kaiser Health Tracking Poll found that 43% of insured adults said they have difficulty affording their deductibles, and 29% reported having problems paying their medical bills.
Even more alarming was the number of people who said they
delayed or skipped medical care altogether due to financial concerns. The KFF
poll reported that 27% of surveyed adults admitted they had postponed getting
healthcare due to costs, while 23% said they skipped a recommended medical test
or treatment altogether. Additionally, 21% said they did not fill a
prescription due to the expense. This would apply to blood draws and other
medical laboratory visits as well.
“We certainly have a high bad-debt rate for the uninsured,” Mark Guinan, Chief
Financial Officer at Quest, told Bloomberg.
“But really the biggest driver is people with insurance. It’s their coinsurance
and their high deductibles, and they don’t always pay their bills.”
The rising costs of healthcare and health insurance in the
US continues to be a burden for everyone involved. When people allocate money
for their monthly expenses, it is clear that many are postponing making payments
for medical services.
As more Americans opt for high-deductible health plans,
healthcare professionals, as well as clinical laboratories and anatomic
pathology groups, will need new strategies for receiving payment for their
services.
The paper’s authors stand by their research and claim “requested corrections” were to protect reputations and not correct inaccuracies
Private equity companies have invested in and acquired clinical laboratories and anatomic pathology groups for the past 25 years. It’s not unusual to find private equity firms buying other medical specialty practices as well. But questioning the reasons behind such acquisitions by private corporations, or physicians’ participation in such practices is, apparently, a no go.
At least that’s what the Journal of the American Academy of Dermatology (JAAD) experienced when it published a peer-reviewed article authored by four dermatologists who wrote, “…junior dermatologists are increasingly seeking employment without ownership in private equity-backed corporate groups whose primary fiscal responsibility lies with their investors.” The authors further suggested that, “Dermatologists should be aware of this history, given the ability of corporations and private equity groups to shape the present and future of our field.”
The paper has since been restored and is available for
download from multiple scientific publication sites, as well as the JAAD site.
It should be noted that Hruza was not the only person who
expressed concerns over the voracity of the claims made by the paper’s authors.
Conversely, some dermatologists openly supported the authors’ claims on
Facebook and condemned the JAAD’s
removal of the paper, the NYT
reported.
The NYT described
outlier practices as “those that perform an unusually high number of often
rare, well-reimbursed medical procedures, and bill high amounts to Medicare.” NYT also noted that “many practices
backed by private equity firms have opened or acquired labs to process
pathology specimens, potentially another source of profit.”
The paper hypothesized that the increasing number of
equity-owned businesses in the field of dermatology is disruptive to that
profession. The authors provided evidence that the trend has emerged due to the
availability of equity funds, high student debt, and the desire for work/life
balance in younger dermatologists.
“It was interesting when we ran the numbers and we were counting how many practices with billing outliers were being acquired by private equity,” co-author Joseph Francis, MD, a dermatologist and Adjunct Clinical Professor of Dermatology, Department of Dermatology, University of Florida College of Medicine, told the NYT. “With every revision of the paper, that number kept increasing. So, it didn’t seem like an anomaly.
“It
wasn’t clear whether these investors realized that the high billing might point
to anything irregular,” Francis added. “They might have just seen that this was
a practice with booming business.”
Sailesh Konda, MD, co-author of the paper, a board-certified dermatologist and Assistant Clinical Professor of Dermatology in the Department of Dermatology, University of Florida College of Medicine, stated that he and his co-authors spent a year researching and writing the paper. After the article was submitted for review, they received constructive feedback, mostly suggesting they maintain a neutral tone.
“We strived to not use any polemic words, which could be
interpreted as bias,” Konda told the NYT.
“We decided to just deal with the facts, which would speak for themselves.”
Two of the authors of the paper, Sailesh Konda, MD (above left), and Joseph Francis, MD (above right), were informed by the editor of the JAAD that they could either correct the “factual errors” contained in the paper or retract the article. However, according to the NYT, the authors stood by their facts and “claimed the requested corrections had to do solely with protecting the reputation of the dermatology profession and certain individuals within the American Academy of Dermatology, the association that publishes the journal.” (Photo copyright: The New York Times.)
The Complainers
The complaints, which primarily came from private equity
executives and dermatologists associated with private equity firms, included
legal threats, the NYT noted. Hruza,
MD, was among those individuals who had reservations about the article. He
specifically objected to the conclusion that “influential dermatology leaders
are being recruited to work for and promote dermatology practices backed by
private-equity firms” and stressed that “implying motivation is a stretch,” the
NYT reported.
Hruza also felt that, even though he was not specifically
named in the paper, he was easily identifiable by references made by the
authors within the article. One of the revisions requested by the journal
editor was to remove any indirect references to influential dermatologists,
including Hruza.
Research Continues
Konda said he intends to continue his research into private
equity and how it is affecting the field of dermatology. “I am passionate about
this topic,” he stated. “I realize we live in a capitalist society and money is
a driving force behind many decisions regardless of the industry. However, I
believe there has to be a balance between profit and patient care.”
The fact that the paper was removed from the journal’s
website is a notable development in the field of peer-reviewed medical
journals. Such journals are widely considered to be an important tool for
researchers and scientists to receive feedback regarding their work. In this
case, an article that was unflattering to private equity and dermatology was
removed from public view and access.
The
experience of the dermatology profession with private equity is compelling; one
those in pathology and clinical laboratory medicine should study. Private
equity companies have been investing in and acquiring clinical laboratory
companies and anatomic pathology groups for decades and will likely continue to
do so.
As hospitals and health networks struggle to implement EHRs and comply with federal regulations, medical laboratories have their own struggles fulfilling orders while dealing with physician burnout
Ever since 2009, when the federal government’s electronic health record (EHR) adoption initiatives first became law, hospital medical laboratory managers have watched their parent healthcare organizations struggle to implement behemoth information systems and comply with new federal adoption and data reporting regulations. In most instances, not entirely successfully.
Ten years and billions of dollars in incentives later, not much has improved. EHRs still lack a common interoperability protocol. And health networks still struggle to comply with federal information exchange requirements, while simultaneously engaging with Medicare data reporting schemes that treat patient data as a form of currency.
However, during that same ten years, clinical
laboratories and anatomic
pathology groups have been successful in implementing interfaces with
physicians’ EHRs to support lab test orders and results reporting.
EHR Costs and
Physician Burnout Increasing
In the current climate of acquisitions and mergers in the
healthcare industry, health networks often find themselves patching together a
mix of disparate, incompatible EHRs. All while the cost of implementing EHR
systems is increasing.
And medical laboratories that must maintain APIs
(application programming interfaces) for data exchange with these changing
systems are finding themselves between two front lines: hospitals and EHR
developers.
Tragically, there’s also growing evidence that EHRs
contribute to physician burnout, a well-known industry problem that Dark Daily reported on in multiple
e-briefings.
For example, a 2017 study published in the Annals of Family Medicine (AFM) found that primary care
physicians spend more than 50% of their time working on tasks associated with EHRs
instead of caring directly for patients.
A similar 2016 study published in the Annals of Internal Medicine (AIM)
found that “For every hour physicians provide direct clinical face time to
patients, nearly two additional hours are spent on EHR and desk work within the
clinic day. Outside office hours, physicians spend another one to two hours of
personal time each night doing additional computer and other clerical work.”
“In addition to the cost of procurement and deployment,
we’re also seeing subsequent increases in higher IT operating costs, higher
departmental operating costs. We’re also seeing lower productivity and lower
employee satisfaction,” Scott
Kolesar, Americas Health Technology
Innovation and Digital Leader for multinational professional services firm Ernst and Young, told Modern Healthcare.
This may be an understatement.
“Where the debate about EHRs still comes in is doctors changing the way they practice and spending an awful lot of time doing data entry type of things,” Michael Burger, a senior healthcare information technology consultant specializing in both clinical and administrative systems and processes at health IT management consultants Point-of-Care Partners, told Modern Healthcare. “They push back to say, ‘We’ve made this enormous investment, and in the end, I’m not sure the care I’m providing is any better or less expensive than if I were doing it on paper.’” (Photo copyright: Point-of-Care-Partners.)
Massive Amounts of
Money
The news, however, isn’t all negative. Some health systems
are reporting efficiency gains—particularly in areas of billing—and perhaps
surprisingly, in faster clinical laboratory test turnaround times.
A recent report from Allied Market Research (AMR) seems to predict future growth in the EHR industry. “The global EHR market was valued at $23.6 billion in 2016, and is expected to reach $33.3 billion by 2023, growing at a CAGR of 5.0% from 2017 to 2023,” noted an AMR press release.
Nevertheless, the lack of true interoperability could be
responsible for a possible reduction in EHR sales as well.
“However, high cost of EHR and increase in concerns
regarding the patient data safety and security are expected to impede market
growth,” the press release also stated.
So, that’s confusing. One thing is certain, EHRs are not
going away.
Indeed, some experts suggest health networks and hospitals
view EHR implementation, maintenance, and upgrades as they would any other
investment. “If you think of EHRs like any other capital system—a phone system,
for instance—they are indispensable, so you have to just put them in your
capital plan,” Jon
Ivins, Vice President, Partner, and attorney at Hirschler Fleischer who specializes in
healthcare disputes, litigation, and regulation, told Modern Healthcare.
For better or for worse, EHRs are here to stay. Hospital and
independent clinical laboratory managers and stakeholders will want to note
this fact and become even better prepared as the EHR industry continues to
develop.
