As hospitals are forced to innovate, anatomic pathologists and medical laboratories will need to adapt to new healthcare delivery locations and billing systems
As new challenges threaten the survival of many hospitals worldwide, medical laboratories may be compelled to adapt to the needs of those transforming organizations. Those challenges confronting hospitals are spelled out in a recent report from management consulting firm McKinsey and Company with the provocative title, “The Hospital Is Dead, Long Live the Hospital!”
A team of analysts led by McKinsey senior partner Penny
Dash, MB BS, MSc, looked at nine trends affecting hospitals in North America,
Europe, Asia, and other regions. These trends, the authors contend, will force
hospitals to adopt innovations in how they are structured and how they deliver
healthcare.
Here are nine challenges hospitals face that have
implications for medical laboratories:
1. Aging Patient Populations
“Patient populations are getting older, and their needs are becoming more complex,” McKinsey reports, and this is imposing higher cost burdens. The US Census Bureau projects that by 2030 approximately 20% of the US population will be 65 or older compared with about 15% in 2016.
The federal Centers for Medicare and Medicaid Services (CMS) reports that this age group accounts for a disproportionate share of healthcare costs. In 2014, CMS states, per-capita healthcare spending was $19,098 for people 65 or older compared with $7,153 for younger adults.
The Census Bureau graphic above illustrates how the age of the US population is changing. People are living longer, and as Dark Daily reported in May, this could present opportunities for medical laboratories and anatomic pathologists, as early detection of chronic diseases affecting older patients could ultimately reduce treatment costs. (Photo copyright: US Census Bureau.)
2. Patients Are Behaving More Like Consumers
“Patients—along with their families and caregivers—expect to
receive more information about their conditions and care, access to the newest
treatments, and better amenities,” McKinsey reports.
Clinical advances are increasing the range of treatments that can be performed in outpatient settings, McKinsey reports. The authors point to multiple studies suggesting that patients can receive better outcomes when more care is delivered outside the hospital. Dark Daily has often reported on the impact of this trend, which has reduced demand for in-hospital laboratory testing while increasing opportunities for outpatient services.
4. Move Toward High-Volume Specialist Providers
Compared with general hospitals, specialized, high-volume “centers
of excellence” can deliver better and more cost-effective care in many
specialties, McKinsey suggests. As evidence, the report points to research
published over the past 12 years in specialist journals.
Some US employers are steering patients to top-ranked providers as part of their efforts to reduce healthcare costs. For example, Walmart (NYSE:WMT) pays travel costs for patients to undergo evaluation and treatment at out-of-state hospitals recognized as centers of excellence, which Dark Daily reported on in July.
UnitedHealthcare’s new preferred lab network also appears to be a nod toward this trend. As The Dark Report revealed in April, the insurer has designated seven laboratories to be part of this network. These labs will offer shorter wait times, lower costs, and higher quality of care compared with UnitedHealthcare’s larger network of legacy labs, the insurer says.
5. Impact of Clinical Advances
Better treatments and greater understanding of disease
causes have led to significantly lower mortality rates for many conditions,
McKinsey reports. But the authors add that high costs for new therapies are
forcing payers to contend with questions about whether to fund them.
As Dark Daily has often reported, new genetic therapies often require companion tests to determine whether patients can benefit from the treatments. And these also face scrutiny from payers. For example, in January 2018, Dark Daily reported that some insurers have refused to cover tests associated with larotrectinib (LOXO-101), a new cancer treatment.
6. Impact of Disruptive Digital Technologies
The McKinsey report identifies five ways in which digital
technologies are having an impact on hospitals:
Automation of manual tasks;
More patient interaction with providers;
Real-time management of resources, such as use of hospital beds;
Real-time clinical decision support to enable more consistency and timeliness of care; and
Use of telemedicine applications to enable care for patients in remote locations.
All have potential consequences for medical laboratories, as Dark Daily has reported. For example, telepathology offers opportunities for pathologists to provide remote interpretation of blood tests from a distance.
7. Workforce Challenges
Many countries are contending with shortages of physicians,
nurses, and allied health professionals, McKinsey reports. The authors add that
the situation is likely to get worse in the coming decades because much of the current
healthcare workforce consists of baby boomers.
An investigation published in JAMA in May indicated that, in the US, the number of active pathologists decreased from 15,568 to 12,839 between 2007 and 2017. In January, Dark Daily reported that clinical laboratories are also dealing with a generational shift involving medical technologists and lab managers, as experienced baby boomers who work in clinical laboratories are retiring.
8. Financial Challenges
In the United States and other countries, growth in
healthcare spending will outpace the gross domestic product, the McKinsey
report states, placing pressure on hospitals to operate more efficiently.
9. More Reliance on Quality Metrics
McKinsey cites regulations in Canada, Scandinavia, and the UK that require hospitals to publish quality measurements such as mortality, readmittance, and infection rates. These metrics are sometimes linked to pay-for-performance programs, the report states. In the United States, Medicare regularly uses quality-of-care metrics to determine reimbursement, and as Dark Daily reported in July, a new Humana program for oncology care includes measurements for medical laboratories and anatomic pathology groups.
The McKinsey report reveals that several trends in
healthcare are forcing healthcare leaders to adopt new strategies for success.
The report’s authors state that their “results show that contemporary
healthcare providers around the world are facing several urgent imperatives: to
strengthen clinical quality; increase the delivery of personalized,
patient-centered care; improve the patient experience; and enhance their
efficiency and productivity.”
These pressures on hospitals typically also require
appropriate responses from clinical laboratories and anatomic pathology groups
as well.
Panel of experts in healthcare and the clinical laboratory market identify key trends and discuss how innovative medical laboratories are adding value—and getting paid for that value
Effective clinical laboratory leadership in today’s value-based healthcare system means demonstrating value within an integrated delivery network. After all, as fee-for-service payment for clinical lab tests gives way to value-added reimbursement arrangements, all medical laboratories will need to justify their share of a value-based payment.
But how can clinical
laboratories alert physicians and their parent hospitals to the real value they
offer to improve patient outcomes and reduce healthcare costs? Though lab leaders
may understand their medical lab’s complexity, accessibility, and impact, the
question is how to direct the effort. The answer lies in a risk that some laboratory
directors may not have considered.
Value-based healthcare systems include hospital-based medical laboratories as an essential part of their integrated health system. And, to lower the cost of care, healthcare systems involved in value-based care know they must become better at coordinating care and offering precision medicine services to their patients.
Year-by-year, more integrated health systems are learning how to eliminate gaps in care and become more proactive in delivering care that helps keep patients healthy. However, the task of leveraging the clinical laboratory in a strategic approach to demonstrating value in those health systems remains daunting. One of the goals of the Clinical Lab 2.0 model developed by the Project Santa Fe Foundation clinical laboratory organization is to demonstrate how labs can achieve two goals:
Create added-value services that improve patient care; and
Have health insurers, accountable care organizations (ACOs), and health networks pay remuneration to the clinical labs for those added-value services.
Pathologists,
Clinical Chemists, and MTs Leave Thy Medical Labs
Expert panelists of a recent webinar hosted by Dark Daily and sponsored by Sunquest Information Systems suggested ways that clinical laboratories could better position themselves to be an asset for their organizations. One way to do this is to get their clinical pathologists, PhDs, and medical technologists out of the lab and engaged with physicians, nurses, and other clinical staff in specific ways that influence the healthcare organization’s overall performance in delivering better patient outcomes at less cost.
“Our labs have
to be equal partners instead of recipients of where things are going,” he stressed.
“We need to be, if not in the driver’s seat, at least in the front seat.”
Mark Dixon (above), President of the Mark Dixon Group LLC, moderated the webinar, which was sponsored by Sunquest Information Systems and The Dark Report, sister publication of Dark Daily. Dixon has more than 30-years’ experience as a health system CEO and COO. He said TriCore and other labs are succeeding at value-based healthcare using methods that are well-defined and available for all clinical laboratories to learn. For example: TriCore has found that certain health insurers are willing to not only pay their laboratory differently, but also meet with the lab’s pathologists and leaders to negotiate value-based care arrangements. (Photo copyright: Mark Dixon Group.)
Fundamental
Changes That Will Impact All Clinical Laboratories
The panel
speakers discussed how clinical laboratories can strategically position
themselves to be successful in today’s evolving healthcare industry. They
predicted several fundamental changes would take place or continue. These
changes include:
A
continued shift away from pure fee-for-service payment (volume) to value-based
reimbursement that rewards improved patient outcomes;
More
discussion regarding prevention of illnesses, chronic diseases, and personal
responsibility;
More
focus on primary care and proactive care;
Rapid
advances in science and technology that will spark development of new healthcare
applications;
Continued
trend toward consumerism, as more patients pay a larger portion of their
healthcare expenses and shop for hospitals, doctors, and labs; and
Intense
cost pressure on healthcare organizations and their medical laboratories.
It was noted
during the panel discussion that, even as the US spends more than any other
country in the world on healthcare, it has some of the worst overall outcomes.
Customers Rapidly
Becoming Stakeholders
“I always think in terms of stakeholders and the number one
stakeholder for any clinical laboratory or healthcare system is always the
customer,” said Peters. “The lab’s customer is the ordering physician. So, it’s
important that labs ‘speak their language’ and understand that the physician’s
customer is the patient.”
Clinical laboratories also must be aware of what a
particular healthcare system is trying to accomplish. “Lab leaders should stay
in constant touch with where the market is, where the system is, and where
reform is,” said Oravetz. “And realize there are things that can be done today
to set up for what’s coming tomorrow.”
Terese said that
for a clinical laboratory to survive during this rapid transformation of
the US healthcare system—or at least continue to thrive—it needs to engage with
the strategic and clinical initiatives guiding every health system around the
country. “There is tremendous opportunity for clinical laboratories to not only
support that transition, but to actually help drive it,” he said. “There’s
nothing wrong with thinking of your medical laboratory as a leader of these
initiatives, versus just as a follower of what the organization is doing.”
Key elements of
the webinar that will be of interest to clinical laboratories include:
Examples
of clinical laboratories navigating the transition from volume to value-based
care;
Discussion
and update on fundamental changes coming to the US healthcare industry that
impact clinical laboratories;
The
case for demonstrating the value of clinical labs to healthcare organizations;
and
Eight
ways to elevate the value of clinical labs within an integrated healthcare network.
The experts on this special discussion panel agree that US
healthcare and the clinical laboratory marketplace is in a time of transition.
Pathologists and medical laboratory scientists have an opportunity to position
themselves as leaders and changemakers to the benefit of patients, as well as their
parent hospitals and health networks.
This free webinar can be a critical tool for leadership
training within every clinical laboratory. It can be used to give lab managers
and lab staff fresh insights into the changes happening in healthcare. Insights
that can guide strategic planning and inspire laboratory-led projects to
collaborate with physicians and improve patient care.
Download this webinar for free by clicking here. (Or, copy and paste this URL into your browser: https://darkintelligenceprogramsondemand.uscreen.io/programs/listen-learn-lead-uncover-ways-you-can-position-your-lab-as-a-strategic-pillar-of-the-healthcare-organization.)
First used to track cryptocurrencies such as Bitcoin, blockchain is finding its way into tracking and quality control systems in healthcare, including clinical laboratories and big pharma
Four companies were selected by the US Food and Drug Administration (FDA) to participate in a pilot program that will utilize blockchain technology to create a real-time monitoring network for pharmaceutical products. The companies selected by the FDA include: IBM (NYSE:IBM), Merck (NYSE:MRK), Walmart (NYSE:WMT), and KPMG, an international accounting firm. Each company will bring its own distinct expertise to the venture.
This important project to utilize blockchain technologies in
the pharmaceutical distribution chain is another example of prominent
healthcare organizations looking to benefit from blockchain technology.
Clinical laboratories and health insurers also are collaborating on blockchain projects. A recent intelligence briefing from The Dark Report, the sister publication of Dark Daily, describes collaborations between multiple health insurers and Quest Diagnostics to improve their provider directories using blockchain. (See, “Four Insurers, Quest Developing Blockchain,” July 1, 2019.)
Improving Traceability and Security in Healthcare
Blockchain continues to intrigue federal officials, health network administrators, and health information technology (HIT) developers looking for ways to accurately and efficiently track inventory, improve information access and retrieval, and increase the accuracy of collected and stored patient data.
In the FDA’s February press release announcing the pilot program, Scott Gottlieb, MD, who resigned as the FDA’s Commissioner in April, stated, “We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain.”
Congress created this latest program, which is part of the federal US Drug Supply Chain Security Act (DSCSA) enacted in 2013, to identify and track certain prescription medications as they are disseminated nationwide. However, once fully tested, similar blockchain systems could be employed in all aspects of healthcare, including clinical laboratories, where critical supplies, fragile specimens, timing, and quality control are all present.
The FDA hopes the electronic framework being tested during
the pilot will help protect consumers from counterfeit, stolen, contaminated, or
harmful drugs, as well as:
reduce the time needed to track and trace
product inventory;
enable timely retrieval of accurate distribution
information;
increase the accuracy of data shared among the
network members; and
help maintain the integrity of products in the
distribution chain, including ensuring products are stored at the correct
temperature.
In the FDA’s February announcement, Scott Gottlieb, MD (above), the FDA Commissioner at that time, said, “For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it, [and] establish a more robust product verification to ensure that a drug product is legitimate and unaltered.” It’s not hard to imagine how such a tracking system would be equally beneficial in clinical laboratories and hospital pathology departments. (Photo copyright: FDA.)
Companies in the FDA’s Blockchain Pilot
IBM, a leading blockchain provider, will serve as the
technology partner on the project. The tech giant has implemented and provided
blockchain applications to clients for years. Its cloud-based platform provides
customers with end-to-end capabilities that enable them to develop, maintain,
and secure their networks.
“Blockchain could provide an important new approach to further improving trust in the biopharmaceutical supply chain,” said Mark Treshock, Global Blockchain Solutions Leader for Healthcare and Life Sciences at IBM, in a news release. “We believe this is an ideal use for the technology because it can not only provide an audit trail that tracks drugs within the supply chain; it can track who has shared data and with whom, without revealing the data itself. Blockchain has the potential to transform how pharmaceutical data is controlled, managed, shared and acted upon throughout the lifetime history of a drug.”
Merck, known as MSD outside of the US and Canada, is
a global pharmaceutical company that researches and develops medications and
vaccines for both human and animal diseases. Merck delivers health solutions to
customers in more than 140 countries across the globe.
“Our supply chain strategy, planning and logistics are built around the customers and patients we serve,” said Craig Kennedy, Senior Vice President, Global Supply Chain Management at Merck, in the IBM news release. “Reliable and verifiable supply helps improve confidence among all the stakeholders—especially patients—while also strengthening the foundation of our business.”
Kennedy added that transparency is one of Merck’s primary
goals in participating in this blockchain project. “If you evaluate today’s
pharmaceutical supply chain system in the US, it’s really a series of handoffs
that are opaque to each other and owned by an individual party,” he said,
adding, “There is no transparency that provides end-to-end capabilities. This
hampers the ability for tracking and tracing within the supply chain.”
Walmart, the world’s largest company by revenue, will
be distributing drugs through their pharmacies and care clinics for the
project. Walmart has successfully experimented using blockchain technology with
other products. It hopes this new collaboration will benefit their customers,
as well.
“With successful blockchain pilots in pork, mangoes, and leafy greens that provide enhanced traceability, we are looking forward to the same success and transparency in the biopharmaceutical supply chain,” said Karim Bennis, Vice President of Strategic Planning of Health and Wellness at Walmart, in the IBM news release. “We believe we have to go further than offering great products that help our customers live better at everyday low prices. Our customers also need to know they can trust us to help ensure products are safe. This pilot, and US Drug Supply Chain Security Act requirements, will help us do just that.”
KPMG, a multi-national professional services network
based in the Netherlands, will be providing knowledge regarding compliance
issues to the venture.
“Blockchain’s innate ability within a private, permissioned
network to provide an ‘immutable record’ makes it a logical tool to deploy to
help address DSCSA compliance requirements,” said Arun Ghosh, US Blockchain
Leader at KPMG, in the IBM news release. “The ability to leverage existing
cloud infrastructure is making enterprise blockchain increasingly affordable
and adaptable, helping drug manufacturers, distributors, and dispensers meet
their patient safety and supply chain integrity goals.”
The FDA’s blockchain project is scheduled to be completed in
the fourth quarter of 2019, with the end results being published in a DSCSA
report. The participating organizations will evaluate the need for and plan any
future steps at that time.
Blockchain is a new and relatively untested technology
within the healthcare industry. However, projects like those supported by the
FDA may bring this technology to the forefront for healthcare organizations,
including clinical laboratories and pathology groups. Once proven, blockchain
technology could have significant benefits for patient data accuracy and
security.
Though the field of oncology has some AI-driven tools, overall, physicians report the reality isn’t living up to the hype
Artificial intelligence (AI) has been heavily touted as the next big thing in healthcare for nearly a decade. Much ink has been devoted to the belief that AI would revolutionize how doctors treat patients. That it would bring about a new age of point-of-care clinical decision support tools and clinical laboratory diagnostic tests. And it would enable remote telemedicine to render distance between provider and patient inconsequential.
But nearly 10 years after IBM’s Watson defeated two human contestants on the game show Jeopardy, some experts believe AI has under-delivered on the promise of a brave new world in medicine, noted IEEE Spectrum, a website and magazine dedicated to applied sciences and engineering.
In the years since Watson’s victory on Jeopardy, IBM (NYSE:IBM) has announced
almost 50 partnerships, collaborations, and projects intended to develop
AI-enabled tools for medical purposes. Most of these projects did not bear
fruit.
However, IBM’s most publicized medical partnerships revolved
around the field of oncology and the expectation that Watson could analyze data
and patients’ records and help oncologists devise personalized and effective
cancer treatment plans. Success in helping physicians more accurately diagnosis
different types of cancer would require anatomic pathologists to understand
this new role for Watson and how the pathology profession should respond to it,
strategically and tactically.
But Watson and other AI systems often struggled to
understand the finer points of medical text. “The information that physicians
extract from an article, that they use to change their care, may not be the
major point of the study,” Mark
Kris, MD, Medical Oncologist at Memorial
Sloan Kettering Cancer Center, told IEEE Spectrum. “Watson’s
thinking is based on statistics, so all it can do is gather statistics about
main outcomes. But doctors don’t work that way.”
Ultimately, IEEE Spectrum reported, “even today’s
best AI struggles to make sense of complex medical information.”
“Reputationally, I think they’re in some trouble,” Robert Wachter, MD, Professor and Chair, Department of Medicine, University of California, San Francisco, told IEEE Spectrum. “They came in with marketing first, product second, and got everybody excited. Then the rubber hit the road. This is an incredibly hard set of problems, and IBM, by being first out, has demonstrated that for everyone else.”
“It’s a difficult task to inject AI into healthcare, and it’s a challenge. But we’re doing it,” John Kelly III, PhD, (above), Executive Vice President, IBM, who previously oversaw IBM’s Watson platform as Senior Vice President, Cognitive Solutions and IBM Research, told IEEE Spectrum. “We’re continuing to learn, so our offerings change as we learn.” (Photo copyright: IBM.)
Over Promises and Under Deliveries
In 2016, MD Anderson Cancer Center canceled a project with IBM Watson after spending $62 million on it, Becker’s Hospital Review reported. That project was supposed to use natural language processing (NLP) to develop personalized treatment plans for cancer patients by comparing databases of treatment options with patients’ electronic health records.
“We’re doing incredibly better with NLP than we were five
years ago, yet we’re still incredibly worse than humans,” Yoshua Bengio, PhD,
Professor of Computer Science at the University
of Montreal, told IEEE Spectrum.
The researchers hoped that Watson would be able to examine
variables in patient records and keep current on new information by scanning
and interpreting articles about new discoveries and clinical trials. But Watson
was unable to interpret the data as humans can.
IEEE Spectrum reported that “The realization that
Watson couldn’t independently extract insights from breaking news in the
medical literature was just the first strike. Researchers also found that it
couldn’t mine information from patients’ electronic health records as they’d
expected.”
Researchers Lack Confidence in Watson’s Results
In 2018, the team at MD Anderson published a paper in The
Oncologist outlining their experiences with Watson and cancer
care. They found that their Watson-powered tool, called Oncology
Expert Advisor, had “variable success in extracting information from
text documents in medical records. It had accuracy scores ranging from 90% to
96% when dealing with clear concepts like diagnosis, but scores of only 63% to
65% for time-dependent information like therapy timelines.”
A team of researchers at the University of Nebraska Medical Center (UNMC) have experimented with Watson for genomic analytics and breast cancer patients. After treating the patients, scientists identify mutations using their own tools, then enter that data into Watson, which can quickly pick out some of the mutations that have drug treatments available.
“But the unknown thing here is how good are the results,” Babu Guda, PhD, Professor and Chief Bioinformatics and Research Computing Officer at UNMC, told Gizmodo. “There is no way to validate what we’re getting from IBM is accurate unless we test the real patients in an experiment.”
Guda added that IBM needs to publish the results of studies
and tests performed on thousands of patients if they want scientists to have
confidence in Watson tools.
“Otherwise it’s very difficult for researchers,” he said.
“Without publications, we can’t trust anything.”
Computer Technology Evolving Faster than AI Can Utilize
It
The inability of Watson to produce results for medical uses
may be exacerbated by the fact that the cognitive computing technologies that
were cutting edge back in 2011 aren’t as advanced today.
IEEE Spectrum noted that professionals in both
computer science and medicine believe that AI has massive potential for
improving and enhancing the field of medicine. To date, however, most of AI’s
successes have occurred in controlled experiments with only a few AI-based
medical tools being approved by regulators. IBM’s Watson has only had a few
successful ventures and more research and testing is needed for Watson to prove
its value to medical professionals.
“As a tool, Watson has extraordinary potential,” Kris told IEEE
Spectrum. “I do hope that the people who have the brainpower and computer
power stick with it. It’s a long haul, but it’s worth it.”
Meanwhile, the team at IBM Watson Health continues to forge ahead. In February 2019, Healthcare IT News interviewed Kyu Rhee, MD, Vice President and Chief Health Officer at IBM Corp. and IBM Watson Health. He outlined the directions IBM Watson Health would emphasize at the upcoming annual meeting of the Healthcare Information and Management Systems Society (HIMSS).
IBM Watson Health is “using our presence at HIMSS19 this
year to formally unveil the work we’ve been doing over the past year to
integrate AI technology and smart, user-friendly analytics into the provider
workflow, with a particular focus on real-world solutions for providers to start
tackling these types of challenges head-on,” stated Rhee. “We will tackle these
challenges by focusing our offerings in three core areas. First, is management
decision support. These are the back-office capabilities that improve
operational decisions.”
Clinical laboratory leaders and anatomic pathologists may or
may not agree about how Watson is able to support clinical care initiatives.
But it’s important to note that, though AI’s progress toward its predicted
potential has been slow, it continues nonetheless and is worth watching.
Especially for busy hospital emergency departments, avoiding blood culture contamination is a constant challenge for those tasked with collecting blood culture specimens
Better, faster diagnosis and treatment of sepsis continues to be a major
goal at hospitals, health networks, and other medical facilities throughout the
United States. Yet microbiologists
and clinical
laboratory managers continue to be frustrated with how frequently
contaminated blood culture specimens show up in the laboratory.
A recent poll of more than 200 healthcare professionals who
attended a
sponsored webinar hosted by Dark Daily, showed that nearly 10% of
those who responded reported an overall blood culture contamination rate in
their hospitals at above 4%.
However, the arrival of new technology may provide hospital
staff with a way to reduce contamination rates in blood culture specimens, in
ways that improve patient outcomes.
The effectiveness of a new tool, the Steripath Initial Specimen Diversion
Device (ISDD), is being demonstrated in a growing number of prominent
hospitals in different regions of the United States. What will be particularly
intriguing to clinical laboratory professionals is that the ISDD is capable of
collecting blood while minimizing the problems caused by human factors, micro-organisms,
and skin plugs or fragments. This device was developed by Magnolia Medical Technologies
of Seattle, Wash.
The ISDD isolates the initial 1.5
to 2.0 mL aliquot of the blood culture sample, which is most likely to be
contaminated with microscopic skin fragments colonized with bacteria. The device diverts this initial aliquot into a sequestration
chamber, mechanically isolating it from the rest of the sample, and then
automatically opens an independent sterile pathway into blood culture collection
bottles.
Such technology may be welcomed by medical laboratory
professionals based in hospitals and other healthcare facilities. That’s
because it is the lab staff that typically identifies a contaminated blood
culture specimen and must go back to the nurses, staffers, and physicians on
the wards to have them redraw an acceptable specimen that will produce an
accurate, reliable result. Patients under these circumstances generally
continue on unnecessary broad-spectrum antibiotics, and their length of stays
have been reported to increase by two days on average.
Problem of Decentralized Phlebotomy
One problem contributing to high blood culture rates is
that, in many hospitals and health networks, phlebotomy has been decentralized
and is no longer managed by the clinical laboratory.
“I’ve seen the havoc decentralized phlebotomy wreaks on contamination rates of blood culture rates,” stated Dennis Ernst, Director of the Center for Phlebotomy Education based in Mio, Mich. “That staffing model, which swept through the hospital industry in the late 1990s, may have looked good on paper, but I can count the number of facilities that have successfully decentralized on the fingers of one hand. And I don’t know of any decentralized setting that has an acceptable blood culture contamination rate.”
Dennis Ernst, MT(ASCP), NCPT(NCCT) (above), Director of the Center for Phlebotomy Education, shared his expertise during a recent webinar hosted by Dark Daily. Ernst considers blood culture contamination to be among the “low-hanging fruit” in every medical laboratory that can be easily and permanently corrected with the proper approach. (Photo copyright: Dennis Ernst.)
Ernst, a medical
technologist and educator, has seen the
difficulty in lowering contamination rates in a decentralized,
multidisciplinary workforce. He has worked for more than 20 years advocating
for best practices in the diagnostic blood collection industry and has helped clinical
laboratory facilities achieve a 90% reduction in their contamination rates. Ernst considers blood
culture contamination to be among the “low-hanging fruit” in every laboratory
that can be easily and permanently corrected with the proper approach.
“One statistic we’ve heard over and over again is that the American Society of Microbiology established the ‘threshold’ for blood culture contamination to be 3%,” Ernst said. “I believe strongly that a 1% contamination rate or less is what should be required and that it’s not only achievable, but sustainable.”
Regardless of
staffing mix, blood culture contamination is a common problem in the emergency
department, Ernst explained during his presentation, “Evidence-Based
Technology to Reduce Blood Culture Contamination, Improve Patient Care, and
Reduce Costs in Your Clinical Lab or Hospital,” which is available
free for streaming.
Improving Patient Care and Reducing Avoidable Costs
With unnecessary
antibiotic use, increased length of stay, and the cost of unnecessary
laboratory testing at issue, hospitals are tracking blood culture collection
results and exploring ways to reduce episodes of blood culture contamination. On these and other healthcare quality
improvement aims, providers are publishing study results on contamination
reduction and potential direct and indirect hospital cost savings. For example:
At the University of Nebraska, a
prospective, controlled, matched-pair clinical study showed an 88% reduction in
blood culture contamination with a 12-month sustained rate of 0.2% when
Steripath was used by phlebotomists in the ED. The author estimated the institution
would save approximately $1.8 million if the technology was adopted
hospitalwide, reported an article in Clinical
Infectious Diseases in July 2017.
Florida-based Lee
Health system’s microbiology laboratory reported an 83% reduction in
contamination rates comparing their standard method to ISDD for a seven-month
trial period. Their systemwide potential cost avoidance estimates ranged from
$4.35 million to nearly $11 million, reported an article in the Journal of Emergency
Nursing in November 2018.
Researchers from Massachusetts General reported that
ISDD is the single most effective intervention so far explored for reducing
costs related to false-positive blood cultures, potentially saving the typical
250- to 400-bed hospital $1.9 million or $186 per blood culture and preventing
34 hospital-acquired conditions (including three C.
difficile cases). The recent article “Model to Evaluate the Impact of
Hospital-based Interventions Targeting False-Positive Blood Cultures on
Economic and Clinical Outcomes” in the Journal
of Hospital Infection explains more.
Blood Facilities Should be Tracking Their Contamination
Rate
One of the biggest challenges faced during blood sample
collection is making sure an organism is not inadvertently introduced into the
blood. Therefore, importance has been placed on clinical laboratories and other healthcare providers
developing policies and procedures to limit the introduction of likely
contaminants.
“I believe most places monitor blood culture contamination,
but they are not doing much that is effective to reduce it,” Ernst said.
“That’s a real problem.”
To assist healthcare providers in blood culture quality
improvement, the free webinar, “Evidence-Based Technology to Reduce Blood
Culture Contamination, Improve Patient Care, and Reduce Costs in Your Clinical
Lab or Hospital,” available on-demand through Dark Daily, can be
downloaded by clicking here,
or by pasting the URL “https://darkintelligenceprogramsondemand.uscreen.io/programs/evidence-based-technology-to-reduce-blood-culture-contamination-improve-patient-care-and-reduce-costs-in-your-clinical-lab-or-hospital”
into a web browser.
This program, which polled more than 200 healthcare
professionals, explores the clinical and economic significance of blood culture
contamination, the downstream impact of false-positive blood cultures, and case-study
evidence of sustained reductions in contamination.
Using animal blood, the researchers hope to improve the accuracy of AI driven diagnostic technology
What does a cheetah, a tortoise, and a Humboldt penguin have
in common? They are zoo animals helping scientists at Saarland University in
Saarbrücken, Germany, find biomarkers that can help computer-assisted diagnoses
of diseases in humans at early stages. And they are not the only animals
lending a paw or claw.
In their initial research, the scientists used blood samples
that had been collected during routine examinations of 21 zoo animals between
2016 and 2018, said a news
release. The team of bioinformatics
and human genetics experts
worked with German zoos Saarbrücken and Neunkircher for the study. The project
progresses, and thus far, they’ve studied the blood of 40 zoo animals, the
release states.
This research work may eventually add useful biomarkers and
assays that clinical
laboratories can use to support physicians as they diagnose patients,
select appropriate therapies, and monitor the progress of their patients. As medical
laboratory scientists know, for many decades, the animal kingdom has been
the source of useful insights and biological materials that have been
incorporated into laboratory assays.
“Measuring the molecular blood profiles of animals has never
been done before this way,” said Andreas
Keller, PhD, Saarland University Bioinformatics Professor and Chair for
Clinical Bioinformatics, in the news release. The Saarland researchers published
their findings in Nucleic Acids
Research, an Oxford
Academic journal.
“Studies on sncRNAs [small non-coding RNAs] are often largely based on homology-based information, relying on genomic sequence similarity and excluding actual expression data. To obtain information on sncRNA expression (including miRNAs, snoRNAs, YRNAs and tRNAs), we performed low-input-volume next-generation sequencing of 500 pg of RNA from 21 animals at two German zoological gardens,” the article states.
Can Animals Improve the Accuracy of AI to Detect Disease
in Humans?
However, the researchers perceived an inability for AI and machine learning to
discern real biomarker patterns from those that just seemed to fit.
“The machine learning methods recognize the typical
patterns, for example for a lung tumor or Alzheimer’s disease. However, it is
difficult for artificial intelligence to learn which biomarker patterns are
real and which only seem to fit the respective clinical picture. This is where
the blood samples of the animals come into play,” Keller states in the news
release.
“If a biomarker is evolutionarily conserved, i.e. also
occurs in other species in similar form and function, it is much more likely
that it is a resilient biomarker,” Keller explained. “The new findings are now
being incorporated into our computer models and will help us to identify the
correct biomarkers even more precisely in the future.”
Andreas Keller, PhD (left), and zoo director Richard Francke (right), hold a pair of radiated tortoises that participated in the Saarland University study. (Photo copyright: Oliver Dietze/Saarland University.)
“Because blood can be obtained in a standardized manner and
miRNA expression patterns are technically very stable, it is easy to accurately
compare expression between different animal species. In particular, dried blood
spots or microsampling devices appear to be well suited as containers for
miRNAs,” the researchers wrote in Nucleic Acids Research.
Animal species that participated in the study include:
Additionally, human volunteers contributed blood specimens
for a total of 19 species studied. The scientists reported success in capturing
data from all of the species. They are integrating the information into their
computer models and have developed a public database of their
findings for future research.
“With our study, we provide a large collection of small RNA
NGS expression data of species that have not been analyzed before in great
detail. We created a comprehensive publicly available online resource for
researchers in the field to facilitate the assessment of evolutionarily
conserved small RNA sequences,” the researchers wrote in their paper.
Clinical Laboratory Research and Zoos: A Future
Partnership?
This novel involvement of zoo animals in research aimed at improving
the ability of AI driven diagnostics to isolate and identify human disease is
notable and worth watching. It is obviously pioneering work and needs much
additional research. At the same time, these findings give evidence that there
is useful information to be extracted from a wide range of unlikely sources—in
this case, zoo animals.
Also, the use of artificial intelligence to search for
useful patterns in the data is a notable part of what these researchers
discovered. It is also notable that this research is focused on sequencing DNA
and RNA of the animals involved with the goal of identifying sequences that are
common across several species, thus demonstrating the common, important
functions they serve.
In coming years, those clinical laboratories doing genetic
testing in support of patient care may be incorporating some of this research
group’s findings into their interpretation of certain gene sequences.
