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

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Clinical Laboratories and Pathology Groups

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Researchers at University of British Columbia Use Human Gut Bacteria to Convert A/B Blood into Universal Type-O

If this technology proves viable on large scale, medical laboratories in hospitals that manage blood banks could have larger supplies of universal blood units

Once again, the amazing human microbiome is at the heart of a new scientific breakthrough that could offer new tools for clinical laboratories and provide much needed resources to emergency departments and hospitals.

Canadian researchers at the University of British Columbia (UBC) in Vancouver have discovered a microbe in the human gut they believe is capable of converting donor blood into “universal” type-O blood.

“We have been particularly interested in enzymes that allow us to remove the A or B antigens from red blood cells. If you can remove those antigens, which are just simple sugars, then you can convert A or B to O blood,” Stephen Withers, PhD, a professor and biochemist at UBC explained in an American Chemical Society (ACS) news release.

Such a breakthrough would be game-changing not only for emergency departments that rely on much-needed supplies of universal-donor blood, but also for the medical laboratories that run most hospital blood banks.

Uncovering a method to transform type A blood into type O would greatly enlarge the current blood supply because type-O blood can be donated to patients regardless of which of the four main blood groups they belong to—O, A, B, or AB.

This is yet another addition to a growing list of discoveries involving human gut bacteria that Dark Daily has reported on in past years.

Withers presented his research at the 256th National Meeting and Exposition of the American Chemical Society 2018 annual meeting in Boston. Click here to watch a video of his presentation.

Using Metagenomics to Convert A/B Blood to Type O

UBC scientists relied on metagenomics—a technique that enables researchers to study microbial communities using DNA sequencing—to investigate enzymes that potentially could destroy all the A and B antigens from red blood cells, thereby converting type A and B blood into Type O universal blood.

“With metagenomics, you take all of the organisms from an environment and extract the sum total DNA of those organisms all mixed up together,” Withers said in the ACS news release. 

Withers’ team considered sampling DNA from mosquitoes and leaches but ultimately turned to the human body, where they found successful candidate enzymes in the gut microbiota. They focused on glycosylated proteins called mucins that line the gut wall, providing sugars that serve as attachment points for gut bacteria, while also feeding them as they aid in digestion, the ACS report noted.

“By honing in on the bacteria feeding on those sugars, we isolated the enzymes the bacteria use to pluck off the sugar molecules,” Withers said in a UBC statement. “We then produced quantities of those enzymes through cloning and found that they were capable of performing a similar action on blood antigens.”

Although enzymes long have been considered a key to transforming donated blood to a common type, the gut enzymes the UBC team identified are 30 times more efficient at removing red blood cell antigens than previously studied enzymes, the ACS news release noted. Their findings demonstrate once again how the human microbiome is intertwined with many processes happening within the body, opening the possibility of future novel uses of enzymes.

“Researchers have been studying the use of enzymes to modify blood as far back as 1982. However, these new enzymes can do the job 30 times better,” Stephen Withers, PhD (above), Professor and biochemist at the University of British Columbia, noted in the UBC statement. Should his technique for converting A and B blood types to type O prove successful on a large scale, emergency departments and medical laboratories that manage blood banks could finally gain a dependable source of blood. (Photo copyright: University of British Columbia.)

Zuri Sullivan, an immunologist and PhD candidate at Yale University, believes the blood-converting enzymes discovered by the USB team may be the first of many discoveries revealed as researchers investigate the untapped potential of the gut microbiome to solve medical challenges.

“The premise here is really powerful. There’s an untapped genetic resource in the [genes] encoded by the gut microbiome,” she told Smithsonian Magazine.

Researchers Have High Hopes but More Testing Is Needed

According to the UBC statement, Withers and UBC colleagues microbiologist Steven Hallam, PhD, and pathologist Jay Kizhakkedathu, PhD, of the UBC Center for Blood Research, are applying for a patent on the new enzymes, while working to validate the enzymes and test them on a larger scale in preparation for clinical testing.

In addition, the ACS news release notes that the UBC team “plans to carry out directed evolution, a protein engineering technique that simulates natural evolution, with the goal of creating the most efficient sugar-removing enzyme.”

“I am optimistic that we have a very interesting candidate to adjust donated blood to a common type,” Withers said in the ACS statement. “Of course, it will have to go through lots of clinical trials to make sure that it doesn’t have any adverse consequences, but it is looking very promising.”

Fortune health journalist Sy Mukherjee praised the UBC discovery, but warned against “coming to any overhyped conclusions” until more testing is done.

“But if it’s a sustainable technique, the implications are multifold,” he noted. “Especially given the nature of the technique itself, which involves lopping off certain antigens (which are, in essence, simple sugars) from particular red blood cells. The question is whether it can be used on a wide-scale in a safe and efficient manner to create larger blood supplies in times of need.”

That certainly is the question. For decades, scientists have searched for the secret to creating universal blood and now it appears the answer may have been lurking inside our bodies all along. Clinical laboratories may soon see human microbiome become linked to even more discoveries that lead to new tests and diagnostic tools.

—Andrea Downing Peck

Related Information:

Gut Bacteria Provide Key to Making Universal Blood

Gut Enzymes Could Hold Key to Producing Universal Blood

What’s the Most Common Blood Type?

In the Quest for Universal Blood, Go with Your Gut

Brainstorm Health: Changing Blood Types, Exact Sciences Pfizer Deal, Israel Bans Juul

Does New Opioid Law Require Clinical Laboratories to Change How They Pay Sales Employees?

Recently enacted EKRA law prohibits payment activities that were legal under the previous Anti-Kickback Statute, confusing clinical laboratories and legal experts alike

There is a relatively new law on the books that impacts clinical laboratories, and lab leaders tasked with ensuring compliance with federal statutes need to fully understand it because getting it wrong could have dire consequences.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (HR 6: aka, the SUPPORT Act), became law effective Oct. 24, 2018, and is primarily intended to address the national opioid epidemic. However, tucked inside the SUPPORT Act is Section 8122: Eliminating Kickback in Recovery Act of 2018 (EKRA), which establishes “criminal penalties for unlawful payments for referrals to recovery homes and clinical treatment facilities.” But how does EKRA apply to clinical laboratories?

“It prohibits any kickback or payment or solicitation of a kickback in exchange for referring patients to clinical laboratories,” Danielle Holley, a health law attorney and shareholder at O’Connell and Aronowitz in Albany, N.Y., told the Dark Daily.

This new law, she says, differs from the previous federal Anti-kickback Statute 42 U.S.C. 1320a-7b(b) and employer safe harbor provisions built into the Patient Protection and Affordable Care Act (ACA), which allowed labs to pay commissions on variable rates to sales and marketing staff.

Thus, it is critical that clinical laboratories understand their requirements under EKRA. Misunderstandings could bring “criminal penalties” which would seriously threaten lab managers and stakeholders.

What Must Labs Do to Comply with EKRA?

Under EKRA, legal experts advise clinical laboratories to no longer pay sales staff on a commission basis.

“Labs are no longer safe by following past advice. They have to rethink payment to sales and marketing personnel,” Holley noted. She explained that labs can no longer pay commissions that vary by:

  • Number of people referred to the lab;
  • Number of lab tests performed; or,
  • Percentage of payment sent to the lab.

EKRA also applies to commercial payers, whereas the federal Anti-Kickback Statute did not, she added.

“Many labs are not coming to grips with what this means to them,” Jeffrey Sherrin, President of O’Connell and Aronowitz, told Dark Daily.

Clinical Laboratories Not Clear on EKRA and Its Implications

EKRA is an all-payer statue that prohibits medical laboratories, clinical treatment facilities, and recovery homes from soliciting payments for referrals, the National Law Review pointed out.

That seems clear enough, but it’s anything but to many legal experts and medical lab industry leaders who are unsure whether EKRA actually applies to clinical labs. It’s possible, some experts claim, that it applies only to toxicology labs, which would make sense given the SUPPORT Act’s original context.

“There is an open issue about whether the description of paying employees applies to toxicology labs or all labs. Even though the focus of this law is toxicology and relationship of labs, sober homes, and treatment centers, the language of the statute seems to cover all clinical laboratories—not just toxicology,” Sherrin said.

“If you want to be safe, you pay on straight salary. The problem is, that does not give an incentive to the salesperson to go out and beat the bushes and hustle to bring in new business (to the lab),” he added.

The SUPPORT Act and EKRA could negatively affect clinical laboratory business should sales and marketing employees choose to work for durable medical equipment companies or other industries that pay them on commission, Sherrin pointed out.

“Some [sales professionals] may find the lab is not lucrative enough. The lab could offer higher salaries, but then the risk is on the lab without assurance business is coming in. These are difficult business decisions,” Sherrin said.

ACLA Seeks Clarity on EKRA and Clinical Labs

The American Clinical Laboratory Association (ACLA) wants clarity on the issue as well. Sharon West, ACLA’s Vice President, Legal and Regulatory Affairs, told The Dark Report, Dark Daily’s sister publication, “We are seeking clarity as best we can from the administration and from Congress. But it’s just not here yet.”

In a letter to the US Department of Health and Human Services Office of Inspector General (OIG), West wrote, “The legislation adds a new section … that would authorize the imposition of criminal penalties for some conduct that currently is permissible under Anti-Kickback Statute safe harbors. As written, section 8122 (EKRA) of the legislation applies to all laboratories, not merely laboratories that perform testing for recovery homes and clinical treatment facilities, and to all services covered by all payers, rather than only items and services covered by the federal healthcare programs.”

Increased Scrutiny of Clinical Laboratories

Barring an act of Congress, it could take a prosecution to ultimately define the issue of whether authorities intended all labs to be covered by EKRA or not, Sherrin said.

“Clinical laboratories need to understand that the environment in which testing is occurring—in particular toxicology testing—is rapidly changing and increasingly sensitive. And, it’s going to be under increasing scrutiny. So, practices that may have passed muster in the past are probably history. Now, this is front-page importance,” Sherrin declared.

Key takeaways Sherrin and Holley will provide to EWC attendees include:

  • Understanding what EKRA is and its impact on clinical labs;
  • Acknowledging the importance of reviewing payment arrangements to bring labs into compliance;
  • Addressing EKRA as an all-payer statute that applies to commercial payers as well as federal healthcare programs.
  • Conducting a risk-assessment of your medical lab’s sales compensation program for compliance with EKRA and the federal Anti-Kickback Statute.

Their presentation at the Executive War College (EWC) takes place from 1:45 pm to 2:35 pm, April 30, at the Sheraton Hotel in New Orleans.

To learn more about this and other critical topics affecting clinical laboratories, register to attend EWC presentations by clicking here, or by placing this URL into your Internet browser (https://www.executivewarcollege.com/register/). Reserve your space today by visiting online or by calling 707/829-8495.

—Donna Marie Pocius

Related Information:

Why the Support Act and EKRA’s Prohibition on Paying Commissions to Sale Reps Was A Surprise and Conflicts with the Federal Anti-Kickback Statute: What Labs Must Know to Stay Compliant

Congress Expands Anti-Kickback Statue to Include All Payors for Laboratories, Clinical Treatment Facilities, and Recovery Homes

ACLA Letter on the Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducement New Opioid Law Hits Labs Paying Sales Commissions

PAMA Price Reporting Update: Insights to Help Prepare to Meet the Requirement

Prior (2018) price reporting cycle offers lessons that can help clinical laboratory benefit administrators and personnel take an informed approach to meeting the requirements of the Protecting Access to Medicare Act of 2014 (PAMA)

With the PAMA Private Payor Price Reporting period under way, some clinical laboratories may be grappling with questions about the new requirements.

Under PAMA, applicable labs must report private payer data on selected Clinical Diagnostic Laboratory Tests (CDLTs) to CMS every three years. For the current cycle, data must be collected from Jan. 1 through June 30.

A six-month review period follows so that laboratories can assess whether the applicable lab thresholds are met. Data must be reported to the Centers for Medicare & Medicaid Services (CMS) during a three-month window starting Jan. 1, 2020, with data due by March 31, 2020.

To help clinical laboratories meet PAMA’s new requirements, CMS defines an applicable laboratory as one that answers yes to the following questions:

1) Does the lab have CLIA certification?

2) Does the lab meet the majority of Medicare threshold, which is either greater than 50 percent of Medicare payments received on CLFS and PFS (Physician Fee Schedule) by National Provider Identifier (NPI) or a hospital lab with a shared NPI bills any Type of Bill (TOB) 14x to Medicare during the six-month reporting timeframe.

3) Does the lab have a minimum of $12,500 payments received from Medicare during the six-month reporting period.

Recent Changes Draw Hospital Outreach Labs

Changes in CMS reporting requirements now include hospital outreach labs, if they meet the other criteria.

Failure to file, or filing late, incomplete, or inaccurate data can result in federal fines for laboratories—up to $10,000 a day.

Sarah Simonson, Director of Laboratory Client Management for Change Healthcare, outlines ways labs can avoid those fines and best prepare for this cycle of private payer reporting.

“Begin with the end in mind,” Simonson said. “Understand what is required and prepare for data extraction.” Simonson is one of several pros who will offer insights during a special post-Executive War College workshop geared to private payer price data reporting under PAMA.

Labs should allow ample time to review extracted data, Simonson said, as well as evaluate the data for quality assurance. It’s also important to understand login requirements and the format required to deliver the data. That means getting your IT team involved.


Trish Hankila, Chief Financial Officer of South Bend Medical Foundation, will return to the Executive War College on Lab and Pathology Management, for a special post-conference workshop on the PAMA price reporting requirement. (Photo copyright: Dark Daily)

Having learned many lessons from the previous reporting cycle, Trish Hankila, Chief Financial Officer of the South Bend Medical Foundation, recommends talking with your internal IT or vendor to ensure that accounts receivable (A/R) reports capture the required data. Review available data to ensure accuracy and completeness of data, and review the A/R report that will be used to transmit that data, she says. 

Hankila, who will also speak at the 24th Annual Executive War College post-conference workshop encourages a visit to the CMS website to obtain documents regarding the data, registration, and submission requirements.

“The Center for Medicare Management, CLFS User Manual explains in detail how to log in to the CMS portal, register the data submitter and data certifier, and the process for submitting and certifying the data,” Hankila said.

CMS will use the data collected to calculate 2021 fees for each individual laboratory Current Procedural Terminology (CPT) code.

“CMS is trying to establish fees that reflect the market value of the tests being performed, using a weighted average of the various amounts paid per CPT code by third-party payers,” Hankila said.

How to structure your data when working with your internal IT team or third-party billing will be one focus of the PAMA workshop, in addition to how to avoid the pitfalls when gathering, analyzing, and reporting lab test price data. The post-conference workshop will benefit administrators and personnel responsible for reporting PAMA data.

“What Hospital and Health Network Labs Must Know to Comply with PAMA Private Payer Price Reporting,” will take place from 8 a.m. to 5 p.m., May 2, in New Orleans.

“The takeaways include understanding PAMA, lessons learned from the prior (2018) cycle, and how to structure your request to your IT/billing department,” Simonson said.

To help attendees prepare to participate in the PAMA workshop, Hankila previewed what South Bend Medical Foundation has learned:

  • Get started early with data gathering and the reconciliation process;
  • Reconcile the data by using other reports from your A/R system;
  • Ensure you have enough time to modify programs; and
  • Do not wait until the last minute to transmit the data.

“There may be issues with registration of the submitter and certifier in the CMS portal, the CMS website, or with your data file that you have prepared for submission,” Hankila said.

More Upcoming PAMA Workshop Highlights

Elizabeth Sullivan, JD, will cover “Compliance and Regulatory Issues Associated with the PAMA Statute and the CMS Final Rule for Reporting Private Payer Lab Test Prices: Risks, Consequences, and Often-Overlooked Requirements.”

Diana Voorhees, MA, CLS, MT, SH, CLCP, CPCO, will cover “Understanding the Requirements for Reporting PAMA Private Payer Lab Test Price Data: Who Reports, What Is Reported, How to Report, When Penalties Apply, and More.”

Kyle C. Fetter, MBA, BA, will present “Key Recommendations for Reporting Your Lab’s Private Payer Price Data: Identifying Data Sources, Using Informatics Tools, Understanding Where Data is Missing or Inaccurate, and Transmitting Your Data.”

Visit executivewarcollege.com for more information and to register.

—Tammy Leytham

Related Information

Useful Lessons for Labs That Report PAMA Data

CMS PAMA Regulations Home Page

Registration for Executive War College Post-Conference Workshop

Medicare-for-All Bill Has Little Chance of Passage in Congress, Even as Universal Healthcare Debate Gains Momentum Among Democratic Presidential Hopefuls

Massive government takeover of healthcare would create single-payer healthcare system, doing away with Medicare Advantage and individual choice

All clinical laboratories and anatomic pathology groups have a strong interest in how any reform of US healthcare at the federal level might be accomplished. In that spirit, Dark Daily is providing a quick overview of the Medicare for All Act of 2019 (HR 1384). The name is misleading. The bill would actually end Medicare and all private health insurance in America.

This element of the proposed bill has not gotten much attention in national media coverage. If Congress did pass the bill as proposed by newly elected US Rep. Pramila Jayapal (D-Wash.), it would eliminate all existing private health plans, as well as the existing Medicare program! That includes Medicare Advantage, which serves 20 million seniors. HR 1384 would replace all of these health programs with a national service-on-demand government-funded system.

Though it’s unlikely to advance through Congress, the fact that this massive federal program is even being considered reflects the thinking certain Congressional representatives have about single-payer health systems.

According to the Seattle Times, the proposed “Medicare for All” program would pay for:

  • Primary care;
  • Prescription drugs;
  • Dental and eye care;
  • Long-term care;
  • Reproductive health; and,
  • Mental-health and substance-abuse treatments.

Though patients would not be charged premiums, copays, or deductibles, no healthcare funding mechanism was actually included in the legislation.

Not All Democrats Are Onboard with Medicare for All

Though more than 100 democratic lawmakers in the House of Representatives are co-sponsoring HR 1384, the legislation has failed to win over key Democrats, including House Budget Committee Chairman John Yarmuth (D-Ky.), who criticized the bill for going beyond an expansion of the Medicare program.

“I don’t consider that to be Medicare for all. It’s universal healthcare, on demand, unlimited,” Yarmuth told The Hill. “It’s all single-payer, no private insurance. It’s a very different thing than Medicare.”

It’s no wonder some oppose HR 1384. The bill proposes to abolish the private health insurance industry, which employs upwards of a half a million people and covers 250 million Americans, noted The New York Times (NYT).

“[Health insurance] companies’ stocks are a staple of the mutual funds that make up millions of Americans’ retirement savings. Such a change would shake the entire healthcare system, which makes up a fifth of the United States economy, as hospitals, doctors, nursing homes, and pharmaceutical companies would have to adapt to a new set of rules,” the NYT added.

Shifting Attitudes Concerning National Healthcare Impact All Healthcare Providers

The legislation is unlikely to become law—especially since single-payer healthcare is not likely to gain traction in the Republican-controlled Senate. Nevertheless, HR 1384 has vaulted “Medicare for All” from a fringe policy proposal to a front-and-center national debate among 2020 Democratic presidential hopefuls.

Democracy for America (DFA)—a one-million-member political action committee—labeled the proposed legislation “the new gold standard” for healthcare transformation.

“Congresswoman Jayapal’s bill establishes a new gold standard in the fight for a practical, cost-efficient way to provide a single standard of quality healthcare to everyone,” DFA CEO Yvette Simpson stated in a press release.

Many health providers disagree. The concept of single-payer healthcare system faces strong opposition from hospitals and health insurers, which are likely to remain a formidable roadblock to universal healthcare.


“I’m disappointed any Democrats are going off on this tangent,” Charles Kahn III, President and CEO of the Federation of American Hospitals, which represents investor-owned and managed community hospitals, told the Washington Examiner. “They should be focusing on the advances that were made under the Affordable Care Act.” (Photo copyright: Federation of American Hospitals.)

A single-payer healthcare system also would result in a massive spending shift, according to a study conducted by the Mercatus Center at George Mason University. The study’s author, Charles Blahous, PhD, states that Medicare for All (M4A) “would place unprecedented strain on the federal budget.”

In “The Costs of a National Single-Payer Healthcare System,” Blahous notes that “by conservative estimates, this legislation would have the following effects:

  • “M4A would add approximately $32.6 trillion to federal budget commitments during the first 10 years of its implementation (2022–2031).
  • “This projected increase in federal healthcare commitments would equal approximately 10.7% of GDP in 2022. This amount would rise to nearly 12.7% of GDP in 2031 and continue to rise thereafter.

“These estimates are conservative because they assume the legislation achieves its sponsors’ goals of dramatically reducing payments to health providers, in addition to substantially reducing drug prices and administrative costs,” he continues.

“A doubling of all currently projected federal individual and corporate income tax collections would be insufficient to finance the added federal costs of the plan,” Blahous concluded.

Medicare for All does not appear primed for passage in Congress. However, clinical laboratory administrators and pathologists should note that single-payer healthcare is no longer a fringe idea within the Democratic party. The concept seems to be steadily moving into the mainstream of political debate. It is a debate with the potential to dramatically change how clinical laboratories and anatomic pathology groups get paid for their diagnostic testing services.

—Andrea Downing Peck

Related Information:

Medicare for All Would Abolish Private Insurance: ‘There’s No Precedent in American History’

Key Dem Chairman Voices Skepticism on ‘Medicaid for All’ Bill

DFA: Jayapal’s Medicare for All Act Sets ‘Gold Standard’ for Vital Healthcare Transformation

Jayapal to Introduce Medicare for All Bill That Overhauls Nation’s Healthcare System

Hospitals Present a Major Roadblock to Medicare for All Act

The Costs of a National Single-Payer Healthcare System

Mt. Sinai Hospital and Cactus Design Studio Create 8-Station Clinical/Research Laboratory to Assess Health and Prevent Disease

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.”

Stark is also Chief Medical Officer, Head of HR Data and Analytics, and Managing Director at Morgan Stanley, as well as being the former Medical Director and Assistant Professor of Health System Design and Global Health at the Institute for Next Generation Healthcare (INGH) at the Icahn School of Medicine at Mount Sinai.


“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.

—JP Schlingman

Related Information:

Later This Year you’ll be Able to Get a Futuristic Medical Check-up at Mount Sinai — We got an Early Peek

Mount Sinai Teamed Up with the Designers Who Created Projects for Nike and Beyonce to Build a Futuristic, New Clinic and it’s Reimagining How Healthcare is Delivered

VIDEO: Lab100 at Mount Sinai: Cactus Case Study

Clinical Lab Management Learning Demand Drives Addition of Sessions at 24th Annual Executive War College on Laboratory and Pathology Management

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.”

—Liz Carey

Related Information

Seminars, Training and Educational Opportunities Through Dark Daily

High-Deductible Health Insurance Plans are Turning Providers into Bill Collectors and They’re Not Happy About It

EHRs Still Cost Millions and Can Contribute to Physician Burnout; Hospital Laboratories Caught in the Middle

Facing Increasing Pressure from an Evolving Regulatory Environment, Clinical Laboratories Need to be ‘Inspection Ready’ in 2019Clinical Lab 2.0: A Project Santa Fe Foundation Initiative

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