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

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

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With Experienced Baby Boomers Retiring in Ever-Larger Numbers, Clinical Laboratories and Pathology Groups Use New Methods to Improve Productivity, Reduce Costs

All labs face the challenge of coping with shrinking budgets and staffing shortages, which is why coaching, management observation, and continuous improvement initiatives are proving helpful to medical laboratories

It’s the biggest generational shift since baby boomers began working in clinical laboratories and anatomic pathology groups. Across the nation, labs are watching their most experienced and knowledgeable medical technologists and other lab scientists retire. The need to train their replacements while maintaining peak productivity and controlling costs is motivating lab leaders to adopt powerful new management methods.

Innovative lab administrators and pathologists recognize that automation and the ability to leverage the increasing amounts of data produced by today’s innovative diagnostic technologies and assays can only go so far in helping to compensate for declining revenues.

This is why one trend is quietly gaining momentum. There are many medical laboratories, pathology groups, and other diagnostics providers working to help their lab staffs create a culture of continuous, meaningful improvement. The stakes are great. Not only is this essential for financial sustainability, it can be the source of competitive advantage with physicians, patients, and payers in today’s increasingly competitive diagnostic market.

This is why many medical laboratories are turning to continuous improvement systems such as Lean to increase personnel skills, reduce waste, and make the most out of shrinking budgets and margins. Yet, without a solid foundation of staff trained in these methods and a framework of processes to encourage improvement, lean laboratory managers often struggle to see consistent, significant improvements.

Optimizing Staff Performance and Developing Improvement Processes with Coaching and Management Observation

Performance Coaching and Management Observation offer powerful tools for laboratory managers to reinforce improvement efforts. They encourage the success of personnel, leverage existing personnel to meet growing demands while maintaining service levels, and establish an effective foundation for Lean execution.

Benefits of effective coaching and management observation sessions for laboratories include:

  • Enhancement of laboratory manager performance and skills;
  • Improved retention of skilled labor and consistent improvement of personnel skills through individualized assessment and improved communication;
  • Establishing a method of creating and maintaining a culture of continuous improvement, while empowering staff across all levels of lab operations; and,
  • Creating a competitive edge on laboratories struggling to implement Lean processes and other optimizations in response to increased workloads, reduced staff, and tighter budgets.

Stephen Stone (left), Managing Director, Argent Global Services, and, Rita D’Angelo, PhD (right), President and CEO, D’Angelo Advantage, spoke at Lab Quality Confab in 2018 on the benefits of coaching and management observation sessions for clinical laboratories and implementing continuous improvement systems using Lean Production Methods. (Photo copyright: Dark Daily.)

“While many laboratories are familiar with management observation because of competency testing, few laboratories use coaching and management observation as part of their Lean efforts.” Stephen Stone, Managing Director at Argent Global Services told Dark Daily. “Coaching and management observation offers laboratories an effective means to not only increase throughput using existing staffing and encourage sustainable growth, but also increase retention of existing skilled personnel and reduce hiring costs.”

Speaking at Lab Quality Confab in Oct. 2018, Stone highlighted why these later benefits are increasingly important to laboratories. Citing data from LabTestingMatters and the American Society for Clinical Pathology (ASCP), he reported that while the job market for medical technologist and laboratory technician openings should increase by roughly 11,300 openings in 2018, fewer than 5,000 individuals are graduating each year from accredited training programs.

Lab Supervisor Retirements Projected to Exceed Staff Retirements

Of possibly greater concern, he goes on to point out, is that projected retirement rates for supervisors are higher than those of staff. This means laboratories which fail to focus on staff development and retention could face further issues in both leadership and staffing shortages should trends continue.

“Investing in and empowering your staff will improve productivity, improve quality, improve safety, and help laboratories to work toward goals as a cohesive team,” Rita D’Angelo, PhD, President and CEO at D’Angelo Advantage, LLC, told Dark Daily. “As a result, costs and waste drop significantly. Coaching and management observation alongside a culture of continuous improvement can help labs to overcome many of the staffing and budget obstacles faced today.”

Preparing Your Lab for Continuous Improvement

To help labs prepare for these significant trends, D’Angelo and Stone will co-present a 90-minute webinar on Jan. 16th titled, “Performance Coaching and Management Observations to Improve Productivity and Efficiency: Strengthening the Skills of Management to Execute a Lean Lab Transformation.”

The webinar will include essential coaching skills to help laboratory managers pass on the skills to serve as Lean champions to personnel and establish the foundation and structure for a lasting culture of improvement within the laboratory.

C-Level laboratory leadership, laboratory directors, managers and supervisors, and key members of continuous improvement teams also can use the interactive Q/A session following the webinar to gain answers to questions and concerns directly facing their laboratories’ efforts to develop continuous improvement processes or implement Lean methodologies.

(To register for this critical Jan. 16th webinar, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/performance-coaching-and-management-observations-to-improve-productivity-and-efficiency-strengthening-the-skills-of-management-to-execute-a-lean-lab-transformation-2-2/.)

—Jon Stone

Related Information:

Performance Coaching and Management Observations to Improve Productivity and Efficiency: Strengthening the Skills of Management to Execute a Lean Lab Transformation

Performance Coaching and Management Observations in the Lab: Master this Proven Way to Develop Your Lab’s Managers, Supervisors, and Lab Staff

Secrets of Effective Culture Change in Hospital and Health System Labs: Engaging Staff to Continuously Improve, Sustain Quality, and Regularly Cut Unnecessary Costs

UnitedHealth Group to Launch Electronic Health Records Platform in 2019; Will It Guide Physicians to Preferred Clinical Laboratory Providers?

Leveraging the user base of its existing Rally mobile wellness platform, UnitedHealth Group plans to expand its new electronic health records system to 50 million benefited members and one million healthcare providers by the end of 2019

Before the end of 2019, UnitedHealth Group plans to introduce an electronic health records (EHR) system that it developed internally. It has a ready market for such a system because of its 50 million beneficiaries and one million providers. But this EHR may raise interesting questions for the clinical laboratory industry if it is designed to guide physicians to UnitedHealth’s preferred clinical laboratories when they use the EHR to order lab tests.

According to Healthcare Dive, UnitedHealth Group (NYSE:UNH) CEO David Wichmann announced plans to roll out a “fully individualized, fully portable” EHR platform in 2019 by leveraging Rally, their existing mobile wellness platform, during their third-quarter earnings call in October. With 20 million registered users already using Rally, this could encourage adoption and use of the new EHR among UnitedHealth Group’s 50 million fully benefited members.

UHC’s IHR Complements EHR Systems

Exact details of the platform’s capabilities are still unclear. However, additional information from a November 27 investors conference indicates that the new platform might function more like Apple’s approach to personal health records (PHRs) and less like a traditional EHR. (See Dark Daily,Apple’s Update of Its Mobile Health App Consolidates Data from Multiple EHRs and Makes It Easier to Push Clinical Laboratory Data to Patients,” March 21, 2018.)

“UnitedHealth executives offered a few more details on Tuesday, leaving the impression that the new IHR [individual health record] would complement, not replace, existing EHRs,” noted FierceHealthcare in their coverage of the conference.

Coverage from Forbes indicates the UnitedHealth IHR will be available to both patients and healthcare providers, with UnitedHealth Group predicting usage by one million medical care providers by the end of 2019.

“A traditional electronic medical record focuses largely on streamlining internal business processes for facilities and medical groups,” Steve Nelson, CEO of UnitedHealthcare (UHC), explained during the conference. “But the IHR connects numerous EMRs, creating a unified and secure source of truth for both consumers and care providers, and unlocking the value of data that is currently trapped in today’s fragmented healthcare system. That means consumers have a much more complete, personal picture of their health needs.” [Photo copyright: UnitedHealth Group/Business Insider.)

Connecting Data from Multiple EHRs to Provide a Big Picture Look at Care

Forbes quotes Nelson as saying, “[The new IHR] also empowers care providers with connected, credible information at the point of care by enabling them to see a patient’s interactions with other clinicians.”

According to Healthcare Dive, Wichmann noted that the UNH health record platform would be “deeply personal” and suggest “best actions” gleaned from medical data. This would allow UnitedHealth to utilize the strong points of Optum—a UnitedHealth Group venture focused on providing health services and innovations—to leverage analytics capabilities aimed at both encouraging patients to take an active role in managing their health and finding the best providers in their area.

LabCorp, Quest Could Benefit from UnitedHealth’s IHR

FierceHealthcare also outlines other acquisitions made by UnitedHealth and Optum over the past 10 years that might play a role in the new system, including:

• Axolotl: a health information exchange provider bought in 2010;

• Picis: a health IT and analytics company bought in 2010;

• Humedica: a Boston-based analytics company bought in 2013; and,

• CentriHealth: developer of an individual health record system acquired in 2017.

In the medical laboratory market, this might also give LabCorp and Quest Diagnostics an inside track given their in-network status with UnitedHealth. However, the larger trend is that the new IHR stands to position UnitedHealth as the central point between patients, doctors, and the overall care experience.

“You might imagine what that could ultimately lead to in terms of continuing to develop a transaction flow between physicians and us and the consumer and us,” Wichmann told investors in their October earnings call, according to Healthcare Informatics. “And us being the custodian to try to drive better health outcomes for people, but also ensure that the highest level of quality is adhered to.”

According to Becker’s Hospital Review, the IHR system is already in testing at three accountable care organizations (ACOs) as of November 2018.

Helping Patients Manage Their Care

The information released in November supports a prediction referenced in Fierce Healthcare by Matt Guldin, a senior analyst at Chilmark Research, that UnitedHealth is focusing on an “Apple-type strategy” with their new platform. However, unlike Apple, UnitedHealth stands to directly benefit from providing a centralized hub of personal health information for consumers looking for ways to manage their care experience while keeping costs affordable in the face of rising premiums and deductibles.

Whether UnitedHealth’s new offering works to replace or supplement existing EHR platforms, their attempt to use data-driven technologies to both shape the healthcare process of benefited members and optimize costs by positioning the company as a middleman between patients and doctors highlights the importance of communicating value for medical laboratory services.

Having a major health insurer develop and launch an electronic health records system with some number of useful functions is one more example of the potential upheavals happening in healthcare today. It is the latest reminder that clinical laboratories and anatomic pathology groups must have a strategy to stay relevant in a medical marketplace that is being transformed by such technologies as the Internet-of-Things, big data, real-time analytics, and artificial intelligence (AI).

For almost 20 years, innovative clinical lab executives and pathologists have pointed out their respective laboratory organizations are information factories. Yet, as of 2019, only a handful of such medical labs have developed services that leverage their lab test data to convert it into actionable intelligence for physicians, patients, and payers—intelligence for which these labs can be paid. UnitedHealth’s plans for its EHR is the latest warning that it is timely for labs to develop informatics strategies that deliver value to the stakeholders they serve.

—Jon Stone

Related Information:

UnitedHealth to Launch ‘Fully Integrated’ EHR Next Year

EHR, PHR or Something In Between? UnitedHealth’s Tech Venture Prompts Skepticism and Intrigue

UnitedHealth to Roll Out Individual Health Record, Predicts What It Will Look like in 10 Years

UnitedHealth to Launch New EHR Service by End of 2019

UnitedHealth Grows Q3 Revenue, Eyes 2019 Expansion

UnitedHealth Plans to Roll Out a New EHR Offering for Consumers and Providers by the End of 2019

UnitedHealth to Debut EHR in 2019: 8 Things to Know

UnitedHealth Group Plans to Unveil Health Record for Members, Providers in 2019

UnitedHealth’s EHR to Serve 50M Members in 2019

UnitedHealth Rolls Out Beta Individual Health Record to 3 ACOs, Touts Promising Early Results

UnitedHealth’s Individual EMR Tested at 3 ACOs, CEO Says

UnitedHealth Group: 50M to Access New Personal Health Record in 2019

Apple’s Update of Its Mobile Health App Consolidates Data from Multiple EHRs and Makes It Easier to Push Clinical Laboratory Data to Patients

Health Insurers Spending Big Dollars to Be Players in ‘Big Data’; Trend Has Implications for Clinical Pathology Laboratories

 

 

Becker’s Hospital Review Lists Top Challenges Facing Hospitals and Health Networks in 2019

Rising cost of prescription drugs tops Becker’s list of ‘headwinds’ facing healthcare industry, but no clinical laboratory issues make the list

Clinical laboratory managers and anatomic pathologists working in hospitals and health network systems will find their employers facing many familiar challenges in the coming year. And a report by Becker’s Hospital Review (Becker’s) predicts the top challenges it expects hospitals and health systems to encounter in 2019.

Topping the list is the rising price of prescription pharmaceuticals, which is a chronic strain on the wallets of hospitals, health networks, and patients. However, other items on Becker’s list may be equally challenging.

Readers of Dark Daily who are pathologists and clinical laboratory managers working in hospitals and health systems will find the list presented by Becker’s in “11 Headwinds Facing Hospitals and Health Systems” to be useful at bringing together the main challenges confronting their parent organizations today.

Drug Prices Spiraling Upward

The top challenges facing hospitals and health networks include:

  • “Pharmaceutical costs, particularly non-generic;
  • “Payers expanding into providers and combining with providers;
  • “Payer market share;
  • “Health IT and cybersecurity costs;
  • “Labor costs and a labor-intensive business;
  • “High costs of bricks and mortar;
  • “Medicare as a larger percentage of health system revenue and Medicare reimbursement softening now and over time as federal deficits rise;
  • “Slowing overall healthcare inflation as hospitals rise;
  • “Siphoning off of better paying commercial patients;
  • “Siphoning off of profitable ancillaries; and,
  • “Entry of big technology firms into healthcare.”

Since pharmacy operations consume an estimated 10% to 20% of the average U.S. hospital’s overall operating budget, persistent drug-price increases can be damaging to a hospital’s bottom line. According to PipelineRx, a medication management company, average inpatient drug spending increased 38.7% on a per admission basis (from $714 to $990) from fiscal year 2013-2015.

“Drug prices for both commonly and infrequently used drugs are spiraling up faster than bundled reimbursements can keep up with,” explained PipelineRx.

And the Vizient Drug Price Forecast estimates that in 2019 health systems can expect a 4.92% increase in the price of pharmaceutical purchases. The Vizient forecast for 2018 had projected a 7.61% boost in drug costs.

“While the projected increase for 2019 is less than 2018, it is still growing quickly,” said Dan Kistner, Senior Vice President, Pharmacy Solutions for Vizient, in a news release. “Two key themes we saw were the continued growth of specialty pharmacy products as a share of total spending and the critical importance of ongoing, robust generic and biosimilar competition on restraining overall price growth.”

In spite of pressure from the White House to lower drug prices, Pfizer is one of several large pharma companies that recently announced drug-price increases beginning January 1. The Wall Street Journal (WSJ) reported Pfizer is boosting the prices of 41 prescription drugs—10% of its portfolio. Elliot Wilbur (above), Senior Equity Research Analyst with Raymond James Financial, told the WSJ that drug companies have raised list prices on 263 drugs by an average of 7.8%. (Photo copyright: CNBC.)

While the 2019 increases are below the double-digit averages seen in 2014 and 2015, the American Hospital Association’s “Trends in Hospital Inpatient Drug Costs: Issues and Challenges” report explains the impact of rapidly rising hospital pharmacy costs.

“Hospitals bear a heavy financial burden when the cost of drugs increases and must make tough choices about how to allocate scarce resources. One hospital put the challenge starkly: last year, the price increases for just four common drugs, which ranged between 479% and 1,261%, cost the same amount as the salaries of 55 full-time nurses,” the report noted.

Meanwhile, many of the other items on Becker’s 2019 “headwinds” list will not surprise healthcare administrators, such as:

  • High cost of stand-alone hospitals;
  • Impact of softening Medicare reimbursements;
  • Health insurers’ changing business model; and,
  • The entry of Apple, Google, and other giant technology companies into the healthcare space.

Becker’s list could be a harbinger of tough times ahead. It should make pathologists and clinical laboratory mangers who work within health networks and hospitals mindful of the importance of adding value to their parent organizations while providing their patients with excellent service.

—Andrea Downing Peck

Related Information:

11 Headwinds Facing Hospitals and Health Systems

Vizient Drug Price Forecast Projects Lower Inflation in 2019 than 2018

Trends in Hospital Inpatient Drug Costs: Issues and Challenges

Vizient Forecasts Nearly 5 Percent Hike in Pharmaceutical Prices for 2019, But Also Potential Downward Trend in Spending

Pfizer to Rise Prices on 41 Drugs in January

 

 

Nebula Genomics Offers FREE Whole Genome Sequencing to Customers Willing to Allow Their Data Be Used by Researchers for Drug Development

Different model for medical laboratory testing has customers receiving compensation for the use of their genetic data while maintaining control over who receives it and how it is used

Clinical laboratory leaders and anatomic pathologists will agree that offering whole genome sequencing to customers for FREE is unique in the direct-to-consumer (DTC) genetics market. Nevertheless, Nebula Genomics (Nebula), a start-up genetics company in Massachusetts, has announced exactly that.

Founded by George Church, PhD, Harvard Medical School/MIT professor of genetics, health sciences and technology, and Harvard graduates Dennis Grishin, PhD, and Kamal Obbad, Nebula aims to connect customers with scientists to advance biomedical research, according to a news release.

Interested customers answer questions about their health history, physical activities, medications, and more. The information helps them earn Nebula credits toward free genetic information. Researchers then can review this biographic information and elect to subsidize the cost of sequencing specific customers in exchange for access to the resulting genomic data, which they use to develop pharmaceutical drugs and treatments.

Customers wishing to avoid answering questions can pay Nebula $99 for a personal genome sequencing, which delivers a basic analysis of their ancestry and inherited traits.

“Ninety-nine bucks will get you a little bit of genetic information. But to get the full thing, companies or researchers will have to be interested in either your traits or your genome or both,” Church told National Public Radio (NPR).

The “full thing,” as Church put it, is a full genome sequence using next-generation sequencing technology, which costs about $1,000. Nebula uses 30-times genetic coverage during the sequencing, BioSpace explained.

“We are using next-generation sequencing technology. This enables us to generate thousands of times more data from a genome than most of our competitors,” Dennis Grishin, PhD, Nebula’s co-founder and Chief Scientific Officer told Digital Trends.

Kamal-Obbad-George-Church-Dennis-Grishin-Nebula-Genomics-Harvard-MIT

Kamal Obbad (left), George Church, PhD (center), and Dennis Grishin, PhD (right) created Nebula Genomics “to bring the costs of personal genome sequencing down to zero and to address the issues of genomic data ownership and privacy,” Grishin told Digital Trends. “Our mission is to achieve mass adoption of personal genome sequencing, which would lead to a genomic revolution that would transform biomedical research and healthcare.” (Photo copyright: Nebula Genomics.)

Transparency, Blockchain, and Consumer Control of Data

Nebula says its process enables participants to control what genetic data researchers can access and how it is used. According to NPR, the process may begin with a researcher or pharmaceutical firm contacting Nebula expressing interest in studying a group of patients with a specific disease—such as diabetes—adding that Nebula follows up the request with an encrypted search of participants.

“Nebula will enable individuals to get sequenced at much lower cost through sequencing subsidies paid by the biopharma industry,” Church told BioSpace. “We need to bring the costs of personal genome sequencing close to zero to achieve mass adoption.”

According to a Ledger Insights (Enterprise Blockchain News) report, a blockchain platform enables customers to choose how they want their data used and by whom and be compensated for it. But the customers’ actual genomic data is stored on an Arvados storage platform at Veritas Genetics, a genome sequencing company Church also co-founded.

“I’m hopeful that this model (financial reward and control over data) will actually attract people where historically people have been very disinterested in participation in research,” Church told NPR.

Putting DNA Sequences Up for Sale

Nebula Genomics is not the only start-up attempting to match customers with DNA buyers. EncrypGen, a peer-to-peer genomic data marketplace founded in 2016, says that it enables DNA data to be bought and sold with DNA tokens.

EncrypGen’s Chief Executive Officer and co-founder David Koepsell, PhD, told The Scientist that the company has plans to soon offer whole genomic testing through a partner and users may be able to subsidize the $1,500 cost with tokens earned through the platform.

“We are the world’s first blockchain genomic marketplace serving as a benefit to science and the public,” EncrypGen claims on its Website.

Medical laboratory leaders may wonder what impact Nebula’s offer for free whole genome sequencing will have. It may result in many more people participating in whole genome sequencing and having a master blueprint for managing their health, which is a good thing. It’s also possible more studies about drugs to precisely prevent and treat disease will go forward as researchers and customers connect and act.

—Donna Marie Pocius

 

Related Information:

Nebula Genomics Launches Platform Offering Opportunity for Free DNA Sequencing and Control Over Personal Genomic Data: Individuals Can Contribute to Medical Breakthroughs and Get Rewards for Sharing Health and Genomic Data

Start-up Offers to Sequence Your Genome Free of Charge, Then Lets You Profit from It

Nebula Genomics Offers Free Whole Genome Sequencing

This Start-up Will Sequence Your Entire Genome for Free—But There’s a Catch

Nebula Launches DNA Blockchain Platform

Nebula Genomics is Among the First Blockchain-based Companies to Reward Users for Contributing Personal Data for Research

Nebula Genomics Wants to Sequence Your Entire Genome for Free … With One Little Catch

These 30 Under 30 Founders Want Your Genome

Blockchain Technology Could Impact How Clinical Laboratories and Pathology Groups Exchange Lab Test Data

Millennials Forge New Paths to Healthcare, Providing Opportunities for Clinical Laboratories

Time, cost, and technology are cited as reasons why Gen Y, or Millennials, choose non-traditional healthcare settings, such as urgent care centers, in greater numbers than other age groups

Younger Americans increasingly seek healthcare through non-traditional means, such as urgent care centers and retail health clinics. This trend among Millennials (AKA, Gen Y) to seek healthcare outside of traditional medical settings could present opportunities for clinical laboratories and anatomic pathology groups that service such providers.

In “For Millennials, a Regular Visit to the Doctor’s Office Is Not a Primary Concern,” the Washington Post (WP) notes that young adults—born between 1981 and 1996—make up the largest generational group in the United States, and that they prefer “convenience, fast service, connectivity, and price transparency.”

The proliferation of retail clinics and urgent care centers demonstrates that those preferences often are not met through a traditional primary care doctor’s office or hospital visit, which Dark Daily has reported on extensively in past years.

“The whole ‘going to the doctor’ phenomenon is something that’s fading away from our generation,” Calvin Brown, a 23-year old graduate of the University of San Diego, told the Washington Post. “It means getting in a car [and] going to a waiting room.”

The WP article is a reposting of a Kaiser Health News article titled, “Spurred by Convenience, Millennials Often Spurn the ‘Family Doctor’ Model.”

To PCP or Not to PCP? That Is the Question

Several polls and surveys in the last few years reveal how young adults are—and are not—choosing to receive care. For example:

  • Kaiser Family Foundation (KFF) polled 1,200 randomly selected people 18-years and older and found that 26% did not have a primary care provider (PCP). And KFF found clear generational differences: 45% of those between 18 and 29 did not have a PCP. But just 28% of those aged 30 to 49 did not have PCPs. KFF concluded that older adults were more likely to have a PCP.
  • The “2017 Consumer Engagement in Health Care Survey” conducted by the Employee Benefit Research Institute (EBRI) and Greenwald and Associates yielded similar results. It found that 33% of people classified as Millennials do not have a primary care doctor, but that only 15% of people aged 50-64 did not have a PCP.
  • The “2016 Health Care Cost and Utilization Report” by the Health Care Cost Institute notes that fewer people overall went to primary care offices from 2012 to 2016. Millennials may be discarding the traditional PCP model, but it seems other age groups also are accessing care in non-traditional ways, as well.
  • The RAND Corporation reported in “The Evolving Role of Retail Clinics” that “Retail clinics typically serve younger adults who do not have a primary care provider,” among other interesting trends about the steady growth of urgent care centers and care centers located in big box stores and pharmacies.

Convenience, Cost, and Connectivity Matter

There are clear reasons younger adults eschew primary care providers. One frequently cited reason is time. It typically takes days or even weeks to be seen by a PCP. Then, there’s the time spent in the waiting room.

Tara Carter, a 20-something young woman living in the Washington, DC, area told Healthline that going to a PCP isn’t an efficient use of her time, and that a retail-type clinic is “sufficient to get the help I need and get out the door and back in bed—without waiting days for an appointment that didn’t fit my schedule.”

Cost also is a factor. With high-deductible health plans becoming more common, especially among lower-income families, pricing transparency of retail clinics is appealing. Millennials report being more comfortable paying $40-90/visit at an urgent care center, than visiting a PCP and not knowing the cost until the bill arrives.

Technology—and their preference for using it—also contributes to Millennials’ choices in PCPs. Telemedicine, for example, is a popular option with young adults. About 40% of Millennials say telemedicine is an “extremely or very important” option, compared to 27% of those who are classified as Gen X, and just 19% of Baby Boomers, according to Healthcare IT News.

Mott-Blair-MD

Kaiser Health News notes that, Mott Blair, MD (above), in Wallace, N.C., adopted technologies in his family medical practice to accommodate millennials. “We do far more messaging and interaction through electronic interface,” he told KHN. “I think millennials expect that kind of connectivity.” He also implemented same-day appointments. (Photo copyright: American Academy of Family Physicians.)

What All This Means for Clinical Laboratories

Clinical labs have, traditionally, been aligned with the primary care provider model. And, as Lab Testing Matters notes, “customer service has historically been assessed by how well the laboratory communicated with the medical staff.”

With younger consumers taking a more active role in defining quality in healthcare, the definition of customer service is changing.

There are some things that labs can do to win the business of Millennials:

  • Provide patients access to their test results;
  • Accept requests from patients for interpretation of those results;
  • Allow patients to request tests without orders from a doctor;
  • Encourage interaction through patient portals;
  • Train lab personnel to communicate with patients;
  • Remain aware of the power of social media; and,
  • Recognize that millennials value price transparency, including lab test prices.

Price transparency is likely to continue gaining importance, as well as precision medicine. Clinical laboratories are, in many ways, well-positioned to serve Millennials. Establishing clear lines of communication, making it easy to access services, and adopting a wider definition of customer service are the paths forward for those pathology labs aiming to serve younger patients.

—Dava Stewart

Related Information:

For Millennials, a Regular visit to the Doctor’s Office Is Not a Primary Concern

Spurred by Convenience, Millennials Often Spurn the ‘Family Doctor’ Model

2016 Health Care Cost and Utilization Report

The (Family) Doctor Isn’t In: Millennials Are Rejecting Primary Care Physicians

The Evolving Role of Retail Clinics

Millennials Demand Telehealth in a Move Away from Traditional Primary Care Model

The Latest Thing Millennials Are Killing? The Primary Care Doctor

 

FDA Clears AI Device for Diagnosis of Diabetic Retinopathy; Is this Favorable for Use of AI in Digital Pathology?

FDA clearance of a cloud-based, AI system capable of diagnosing diabetic retinopathy using retinal images highlights the potential for deep learning and algorithmic analysis to assist and, in some cases, replace diagnosticians in medical tests

While clinical laboratories and anatomic pathologists have seen an increasing amount of research and concepts related to artificial intelligence (AI) for diagnostic purposes, few technologies have reached a point where they are ready for clinical applications.

However, the FDA’s recent clearance of the IDx-DR AI diagnostic system from IDx Technologies Inc. of Coralville, Iowa, through the De Novo premarket review pathway, illustrates how image-based AI systems might one day help clinicians, anatomic pathologists, and other care providers diagnose disease and guide therapy decisions.

Already in use at University of Iowa Hospitals and Clinics (UIHC), the device uses cloud computing and algorithms to “autonomously analyze images of the retina for signs of diabetic retinopathy,” according to the IDx website.

This allows IDx-DR to provide a screening decision roughly 20 seconds after image capture.

The IDx-DR system

The IDx-DR system (above) delivers a binary result. When signs of diabetic retinopathy are present, the system recommends a follow-up with an ophthalmologist. If it detects no signs of the condition, the system recommends a follow-up screening in one year. All of this happens without input from a clinician or the services of a medical laboratory. (Photo copyright: Modern Healthcare.)

In a clinical study involving 900 participants published in Nature, a similar AI system achieved 87.2% sensitivity and 90.7% specificity in the detection of diabetic retinopathy, exceeding pre-specified primary endpoint goals.

“AI tools can help physicians handle a lot more data a lot more quickly and help them prioritize,” Susan Etlinger, an industry analyst with the Altimeter Group, told Modern Healthcare. “Theoretically, that could give a family physician a lot more tools in [his/her] toolbox to be able to run an initial diagnostic on somebody and then refer that person for additional treatment.”

Full Integration Shows Promise for Streamlining AI and Diagnostics Workflows

The ability to reach a diagnosis without a clinician already holds potential to drastically impact the workflows and services of medical laboratories and other diagnosticians. However, IDx Technologies also showed how AI might influence data interfacing, while explaining to Modern Healthcare how they have integrated IDx-DR with the electronic health record (EHR) systems of UIHC.

“No one has ever integrated a diagnostic system where there’s no human involved,” noted Michael Abramoff, MD, PhD, Chief Executive Officer and founder of IDx. “We’re ramping up slowly because we want to make sure we work out all the kinks with the EHR and the workflow.”

Once the AI system analyzes images captured by a Topcon TRC-NW400 non-mydriatic retinal camera, results are then automatically communicated to an EHR using Health Level-7 (HL7) interfacing. The entire process is automated once the image is captured.

“The general advantages of AI include automation of certain tasks. This automation allows for increased scale, i.e. increased access, to a service. For systems like IDx-DR, it also allows talent to shift focus to other high priority areas.” Maia Hightower, MD, Chief Medical Information Officer and Chief Population Health Officer for University of Iowa Healthcare, told Digital Journal. “Healthcare is an industry where there is a critical shortage of key talent including medical assistants, nurses, and physicians. AI helps to detect both operational and clinical high-risk areas so that limited resources can be targeted to areas of highest need or greatest return.”

The process used by UIHC highlights potential benefits for medical laboratories as AI continues to impact diagnostic workflows and information processing. The ability to streamline workflows and offload repetitive tasks to automation or AI could allow skilled laboratory workers to further focus on diagnosing complex or difficult cases.

Ryan-Amelon-PhD-IDx

“Due to the highly robotic nature of the camera and the fully autonomous diagnosis, virtually anyone in a healthcare setting can be trained to operate IDx-DR,” Ryan Amelon, PhD, Director of Research and Development at IDx told Digital Journal. “The result is displayed to the user in under a minute or inserted directly into the EMR. The entire patient experience is roughly five minutes.” (Photo copyright: LinkedIn.)

Applying AI to More types of Medical Diagnoses

In an editorial published in NPJ Digital Medicine, Pearse Keane, MD, a clinician scientist at the National Institute for Health Research (NIHR) in the UK, and Eric J. Topol, MD, Director of the Scripps Translational Science Institute (STSI) and Executive Vice President at Scripps Research Institute, posted questions concerning the IDx-DR system and its FDA clearance.

According to Healthcare IT News, key concerns includes:

  • A relatively small sample size to determine diagnostic accuracy;
  • The ability of clinics to incorporate retinal screening into their practices; and,
  • The ability for IDx-DR to detect diabetic neuropathy when patients present other more severe retinal conditions.

Despite these concerns, Keane and Topol note, “While it is always easy to be critical of studies that forge new ground, it is important to applaud the authors for this pivotal work.”

For anatomic pathology laboratories, the IDx-DR system represents a proof of concept that AI and deep learning can analyze medical images—in this case, retinal photographs—and work alongside or in place of trained professionals to make decisions and guide the diagnosis process. How long before similar AI diagnostic systems find their way into clinical laboratories?

“Although deep learning will not be a panacea, it has huge potential in many clinical areas where high dimensional data is mapped to a simple classification and for which datasets are potentially stable over extended periods,” Keane and Topol concluded in their editorial. “As such, it will be incumbent on healthcare professionals to become more familiar with this and other AI technologies in the coming years to ensure that they are used appropriately.”

—Jon Stone

 

Related Information:

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New AI System That Tests for Diabetic Eye Disease

University of Iowa Healthcare Rolls Out First Autonomous AI Diagnostic System Cleared by the FDA

FDA Greenlights Tool for Automated Detection of Diabetic Retinopathy in Primary Care

The FDA Just Opened the Door to Let AI Make Medical Decisions on Its Own

AI Can Deliver Specialty-Level Diagnosis in Primary Care Setting

U.S. FDA Approves AI Device to Detect Diabetic Eye Disease

 

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