Lab100 is designed to be easily upgraded with the latest medical laboratory technologies for tracking patients’ health metrics and risk for chronic diseases
Mount Sinai Hospital
and Cactus, a New York City-based
design studio, are creating a hybrid clinical laboratory/research lab that uses
the latest diagnostic technologies to assess peoples’ health, provide them with
an overview of their current condition, and suggest lifestyle changes to
prevent future diseases.
Though still under development, Lab100 is an innovative approach to
modernizing annual physical/medical check-ups. It was created to empower
patients to track and understand their own health metrics and optimize their overall
health.
Lab100 looks at an individual’s medical history and measures
vital signs, blood analysis, anthropometrics, body
composition, cognition, dexterity, strength, and balance. It’s designed to be
more extensive than the traditional, annual physical, as well as to support the
implementation of preventative measures to avoid disease.
8-Station Clinical
Laboratory Built for Future Expansion
Lab100 consists of eight stations that are built on a
reconfigurable grid system that ensures the system can easily be upgraded with new
technology as it becomes available.
“By definition, no one knows what the future of healthcare
is, and neither do we. We made our best initial guess, recognizing that we’re
going to change based on the data we collect,” David Stark, MD, the
Director and founder of Lab100, told Business Insider. “It may turn out
that we jettison some of these stations and put in additional stations.”
“We’re trying to give patients more visibility, not only into their health, but into how healthcare happens with the hope that that visibility engages them as patients,” David Stark, MD, MS (above), Director and founder of Lab100, told Business Insider. Should Lab100 prove successful, it could become a model for future similar medical laboratories nationwide. [Photo copyright: Business Insider.]
Before visiting Lab100 patients complete a pre-visit
assessment consisting of standardized medical surveys including medical
history, nutritional habits, physical activity, mental health, and sleep
habits. With patients’ consent, individual data are shared with a select group
of researchers to potentially power new discoveries.
Lab100’s eight stations and their purposes are:
Station
One: A patient’s photograph is taken to put a face with the medical record.
The picture also allows researchers to perform more speculative work by
extracting facial features and correlating them with health metrics.
Station
Two: The patient’s vital signs (temperature, height, weight, blood
pressure, pulse, and oxygen levels) are taken.
Station
Three: A venous blood sample is extracted to measure electrolytes, nutrient,
and cholesterol levels. Patients do not need to fast for the blood draw. The
blood test is analyzed onsite and the results are available within 30
minutes.
Station
Four: The patient steps on a 3D full-body scanner where a depth-sensing
camera scans the body and creates a high-resolution 3D avatar of the
individual.
Station
Five: A body composition test is performed using bioelectrical
impedance analysis. A small electrical current is run through the body to
determine the distribution of water, fat, protein, and minerals in the body and
to measure how muscle and fat are distributed throughout the body.
Station
Six: Cognition is
analyzed using a traditional pegboard dexterity test. To perform this test, a
patient dons headphones and interacts with an Apple iPad to test vocabulary,
processing speed, flexibility, episodic memory, and attention.
Station
Seven: The patient’s overall strength is measured by utilizing virtual
reality to determine grip strength and push the patient to give their maximum
performance.
Station
Eight: The patient steps onto a balance pod to test their balance. An iPod
with an accelerometer
placed around the patient’s waist measures sway as the individual tries to stay
as still as possible.
The entire Lab100 process takes about 90 minutes and is one-on-one between patient and physician. Test results at each of the eight stations are held until the end of the visit where they are cumulatively displayed on a screen for the patient and physician to review. Blood analyses are included in patients’ work-ups. (Photos copyright: Lab100.)
Engaging Patients in
Their Own Healthcare
When patients complete their Lab100 experience, they should
have a better understanding of their current health and any changes they can make
in their lives to improve their health and possibly avoid future disease. The
results allow a patient to learn their risks for some diseases and whether
interventions—such as changes in diet and exercise—could alter those risks.
“The idea here is not to obsess over every number, but to
holistically look at what’s going well, what isn’t going well, and come away
with one to three domains that you as the patient want to focus on,” Stark
noted.
The initial Lab100 visit serves as a baseline for comparing
with future visits to measure improvements as a result of lifestyle changes. It
also allows patients to compare their health metrics to others in the same age
range.
Lab 100 is still in the testing stages and could be
available to the public later this year. It is not intended to be a replacement
for primary care and does not diagnose disease. It is intended to serve as a
complement to a traditional office visit and focuses on preventative measures
to avoid illness. The researchers involved in the Lab100 project hope the
environment can ultimately be used to produce new diagnostics, therapeutics, and
tools for measuring health.
Clinical laboratories could soon have new tests for determining how fast a patient’s digestive system is aging as part of a precision medicine treatment protocol
When it comes to assessing human age and longevity, much research has focused on telomeres in recent years. Now clinical laboratory managers and pathologists will be interested to learn that provocative new research demonstrates that the human microbiome may also contain useful information about aging. Microbes that can be diagnostic biomarkers may be one result of this research.
From preventing weight loss to improving cancer treatments to stopping aging, human microbiome—especially gut bacteria—are at the heart of many near miraculous discoveries that have greatly impacted clinical pathology and diagnostics development. Dark Daily has reported on so many recent studies and new diagnostic tools involving human gut bacteria it’s a wonder there’s anything left to be discovered. Apparently, however, there is!
Using artificial intelligence (AI) and deep-learning algorithms, researchers at Insilico Medicine in Rockville, Md., have developed a method involving gut bacteria that they say can predict the age of most people to within a few years. Located at Johns Hopkins University, Insilico develops “artificial intelligence for drug discovery, biomarker development, and aging research” notes the company’s website.
According to a paper published on bioRxiv, an online biomedical publications archive operated by Cold Spring Harbor Laboratory, the Insilico scientists have “developed a method of predicting [the] biological age of the host based on the microbiological profiles of gut microbiota” as well an “approach [that] has allowed us to define two lists of 95 intestinal biomarkers of human aging.”
“This microbiome aging clock could be used as a baseline to test how fast or slow a person’s gut is aging and whether things like alcohol, antibiotics, probiotics, or diet have any effect on longevity,” Alex Zhavoronkov, PhD (above), one of the study’s authors and founder of Insilico Medicine, told Science. (Photo copyright: Insilico Medicine.)
Clinical Laboratories
Might Be Able to Use AI and Gut Bacteria to Predict Age
To perform the study, the researchers collected 3,663 gut bacteria samples from 10 publicly available data sets containing age metadata and then analyzed the samples using a machine learning algorithm. The samples originated from 1,165 healthy individuals who were between the ages of 20 and 90. The individuals used for the study were from Austria, China, Denmark, France, Germany, Kazakhstan, Spain, Sweden, and the US.
The researchers divided the samples equally among three age
groups:
20 to 39 years old (young);
40 to 59 years old (middle aged); and,
60 to 90 years old (old).
The samples were then randomly separated into training and
validation sets with 90% of the samples being used for training and the
remaining 10% making up the validation set.
The scientists trained a deep neural network regressor to predict the age of the sample donors by looking at 95 different species of bacteria in the microbiome of the 90% training set. The algorithm was then asked to predict the ages of the remaining 10% of the donors by looking only at their gut bacteria.
They discovered that their computer program could accurately
predict an individual’s age within four years based on their microbiome. They also
were able to determine that 39 of the 95 species of bacteria examined were most
beneficial in predicting a person’s age.
In addition, the researchers found that certain bacteria in
the gut increase with age, while other bacteria decrease as people age. For
example, the bacterium Eubacterium
hallii, which is associated with metabolism in the intestines, was found to
increase with age. On the other hand, one of the most plentiful micro-organisms
in the gut, Bacteroides
vulgatus, which has been linked to ulcerative colitis,
decreases with age.
Understanding
Microbiome’s Link to Disease
The human microbiome consists of trillions of cells
including bacteria, viruses, and fungi, and its composition varies from
individual to individual. Scientific research, like that being conducted at
Insilico Medicine, expands our understanding of how gut bacteria affects human
health and how diseases such as inflammatory bowel disease, arthritis, autism, and obesity, are linked to the
microbiome.
This type of research could be used to determine how the
microbiomes of people living with certain illnesses deviate from the norm, and
possibly reveal unique and personalized ways to create healthier gut bacteria.
It also could help researchers and physicians determine the best interventions,
drugs, and treatments for individual patients dealing with diseases related to
aging. Such advancements would be a boon to precision medicine.
“Age is such an important parameter in all kinds of diseases.
Every second we change,” Zhavoronkov told Science. “You
don’t need to wait until people die to conduct longevity experiments.”
Further research is needed to develop these findings into
diagnostic tests acceptable for use in patient care. However, such tests could
provide microbiologists and clinical laboratories with innovative tools and
opportunities to help physicians diagnose patients and make optimal treatment
decisions.
Clinical laboratory and pathology leaders need strategies and solutions for reversing the negative market forces that are eroding the financial stability of many of the nation’s independent medical labs
While there are many national
conferences in the clinical and anatomic pathology laboratory industry, the Executive War College on Laboratory and
Pathology Management is the only conference laser-focused on lab management,
operations, and financial stability.
This year, the demand for knowledge has driven the addition of 25 sessions,
and post-conference workshops focused on PAMA and value-based Lab 2.0
innovation.
“Clinical laboratory management has grown in complexity, and the conference has grown in turn,” said Robert L. Michel, Editor-In-Chief of The Dark Report. “This year, we’ll present learning opportunities covering a wider range of lab management issues.”
The finalized Executive War College agenda highlights insightful programs from more than 120 speakers and experts from all sectors of clinical laboratory and pathology management, including expertise from Quest Diagnostics and LabCorp; Geisinger Health System, Mayo Clinic, Baylor College of Medicine, and Duke Health; the College of American Pathologists; McKesson Medical-Surgical; Humana and Aetna; and Change Healthcare, to name a few.
“The Executive War College is the only place in the United States where you can hear leaders of innovative labs share what’s working in their labs, particularly in the areas most important for leaders of clinical laboratories and anatomic pathology groups,” Michel said.
Federal laws, such as the Protecting Access to Medicare Act (PAMA) of 2014, and the SUPPORT Act (with anti-kickback-oriented EKRA), are putting pressure on medical labs, Michel said. A new post-conference workshop on PAMA, as well as a Day 1 Breakout Session on the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) will present the latest insights for compliance.
Michel said he also expects high interest in critical areas of clinical laboratory management, such as better managing and cutting costs, how to offset Medicare lab price cuts and shrinking lab budgets, and understanding precisely how Medicare fee cuts are taking money away from labs and causing erosion in the financial stability of many of the nation’s independent medical labs.
The 24th Annual Executive War College on Laboratory and Pathology Management will offer a wider range of educational opportunities. (Photo copyright: Dark Daily)
Popular sessions at Executive War College include the management master classes and the case study breakouts. Roundtable discussions will include the expertise of nationally and internationally recognized chief financial officers and informatics specialists. And Lab 2.0 represents the new healthcare business development strategy based on value rather than volume.
The 24th Annual Executive War College on Laboratory and Pathology Management will be held Tuesday and Wednesday, April 30-May 1, with two optional workshops, Thursday, May 2, at the Sheraton Hotel in New Orleans. Registration is still open, and scholarship opportunities are available.
This year’s benefactors include Beckman Coulter, Change Healthcare, ELLKAY,
LIFEPOINT Informatics, medspeed, NovoPath, Quadax, Roche, Siemens Healthineers,
Sunquest, TELCOR, and XIFIN.
“The value of networking here is immense,” Michel said. “The peer-to-peer
interaction and real-world medical laboratory mindshare are unmatched with any
other conference.”
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.
