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

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Clinical Laboratories and Pathology Groups

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Stanford Medicine Seroprevalence Study of Dialysis Patients Shows Fewer than One in 10 Adults Has Antibodies to COVID-19 Indicating Herd Immunity is Far Off

Researchers conducted antibody testing on ‘remainder plasma,’ which could inform strategies for ongoing SARS-CoV-2 clinical laboratory surveillance testing

In a clever use of stored clinical laboratory specimens, researchers in California conducted a nationwide seroprevalence survey—serology testing to determine the number of people in a population that carry a specific disease—that used “remainder plasma” from dialysis patients to look for antibodies to the COVID-19 infection. They found that—as of July—fewer than one in 10 adults tested had acquired antibodies to the SARS-CoV-2 coronavirus.

According to Julie Parsonnet, MD, Stanford Professor of Medicine and of Epidemiology and Population Health, and a study author, this indicates that the US population is a long way from herd immunity to COVID-19. “This is the largest study to date to confirm that we are nowhere near herd immunity,” she said in a Stanford Medicine press release.

Herd immunity is the point at which a large part of the population becomes immune to a specific disease. Scientists, according to the Stanford press release, estimate that 60%-70% of the population must have antibodies to the coronavirus before COVID-19 fades.

The study published in The Lancet, titled, “Prevalence of SARS-CoV-2 Antibodies in a Large Nationwide Sample of Patients on Dialysis in the USA: A Cross-Sectional Study,” was a collaboration between California’s Ascend Clinical Laboratories and Stanford University School of Medicine.

The graphic above taken from Stanford Medicine’s published study illustrates the “prevalence of SARS-CoV-2 antibodies in sampled population, by state
The graphic above taken from Stanford Medicine’s published study illustrates the “prevalence of SARS-CoV-2 antibodies in sampled population, by state. Bolded borders represent states with more than 100 patients in the sample. The median number of patients sampled by state was 176 (IQR 83–536). States in white were not sampled.” (Graphic copyright: Stanford University.)

Dense Urban Populations at Greater Risk for COVID-19

The Stanford researchers analyzed samples of remainder plasma from 28,503 randomly selected patients receiving dialysis in July at more than 1,300 dialysis facilities in 46 states. They found that 8% of people were positive for COVID-19 antibodies, which when standardized to the US adult population, equals 9.3% nationwide, the study notes.

However, they also found that people living in densely populated areas were 10 times more likely to show evidence of past COVID-19 infection, and that people living in predominantly black and Hispanic neighborhoods were two to three times more likely to be seropositive than those in white neighborhoods, the researchers wrote.

Of the use of remainder plasma for their study, the researchers wrote, “Testing remainder plasma from monthly samples obtained for routine care of patients on dialysis for SARS-CoV-2 antibodies therefore represents a practical approach to a population-representative surveillance strategy, informing risks faced by a susceptible population while ensuring representation from racial and ethnic minorities.

“In addition, seroprevalence surveys in patients receiving dialysis can be linked to patient-level and community-level data to enable evaluation and quantification of differences in SARS-CoV-2 prevalence by demographic and neighborhood strata, and thus facilitate effective mitigation strategies targeting the highest-risk individuals and communities,” added the researchers.

As reported in Physician’s Weekly, the study also found:

  • When standardized to the US dialysis population, seroprevalence ranged from 3.5% (95% CI, 3.1-3.9) in the West to 27.2% (95% CI, 25.9-28.5) in the Northeast.
  • Large variations in seroprevalence by state were seen, with early COVID-19 hot spots such as New York (33.6%), Louisiana (17.6%), and Illinois (17.5%) having higher rates than neighboring states—Pennsylvania (6.4%), Arkansas (1.9%), and Missouri (1.9%).
  • When compared with other measures of SARS-CoV-2 spread, seroprevalence correlated best with deaths per 100,000 population.
“With this survey, we were able to provide a very rich picture of the first wave of the COVID-19 outbreak in the U.S. that can hopefully help inform strategies to curb the epidemic moving forward by targeting vulnerable populations,” said Shuchi Anand, MD (above left, with fellow Nephrologists Colin Lenihan and Michelle O’Shaughnessy), Director of Stanford’s Center for Tubulointerstitial Kidney Disease and lead author of the study. (Photo copyright: Stanford Medicine.)

Nearly 10% of COVID-Positives Are Undiagnosed

In another important finding that compared seroprevalence and case counts per 100,000 population as of June 15, the study reports that only 9.2% of the COVID-19 seropositives had been diagnosed with the disease.

Because dialysis patients get monthly laboratory blood tests that generate leftover blood plasma samples, researchers believe this remainder plasma can serve an important role in tracking COVID-19’s prevalence in the general population.

“Not only is this patient population representative of the US population, but they are one of the few groups of people who can be repeatedly tested,” said Anand in the Stanford press release. “This is a potential strategy for ongoing SARS-CoV-2 antibody testing and surveillance.”

In an accompanying editorial in The Lancet, titled, “SARS-CoV-2 Antibody Seroprevalence in Patients Receiving Dialysis in the USA,” UK researchers Barnaby Flower, PhD, Department of Infectious Disease, Faculty of Medicine, Imperial College London, and Christina Atchison, PhD, Faculty of Medicine, School of Public Health, Imperial College London, praised the Stanford research.

“Questions remain around the longevity of the immune response and correlates of protection, but high-quality longitudinal serosurveillance with accompanying clinical data can help to provide the answers,” they wrote. “Anand and colleagues deserve credit for pioneering a scalable sampling strategy that offers a blueprint for standardized national serosurveillance in the USA and other countries with a large haemodialysing population.”

Pandemic Fatigue and the Vaccine

While the promised vaccine provides hope for an end to the pandemic, experts say the battle is far from won.

“We are still in the middle of the fight,” epidemiologist Eli Rosenberg, PhD, Associate Professor at the University at Albany in New York, who was not part of the Stanford study, told the Washington Post, “We’re all tired, and we’re all hoping for a vaccine. This shows us how it’s not over here, not even by a long shot.”

What is obvious is that clinical laboratories will continue to play a vital role in response to the COVID-19 pandemic. In fact, just as the management and scientific team at Ascend Clinical Laboratories recognized that remainder plasma from testing dialysis patients could be the foundation of a national seroprevalence survey for COVID-19, other clinical laboratories in different regions of the United States may have similar resources that can be adapted as tools to study and understand the SARS-CoV-2 pandemic. 

—Andrea Downing Peck

Related Information:

Fewer than 1 in 10 Americans Show Signs of Past Coronavirus Infection, Large National Study Shows

Prevalence of SARS-CoV-2 Antibodies in a Large Nationwide Sample of Patients on Dialysis in the USA: A Cross-Sectional Study

Fewer than 1 in 10 Americans Have Antibodies to Coronavirus, Study Finds

New Trump Pandemic Advisor Pushes Controversial ‘Herd Immunity’ Strategy, Worrying Public Health Officials

SARS-CoV-2 Antibody Seroprevalence in Patients Receiving Dialysis in the USA

COVID-19: Herd Immunity?–The U.S. Isn’t Even Close

Mount Sinai Health System Study Finds Use of AI-Enabled Monitoring System Improves Use of Blood During Childbirth

Study suggests AI-enabled technology can help clinical laboratories and hospital blood banks save thousands of dollars annually on expensive blood products

Artificial intelligence may prove to be a useful tool in helping hospitals better manage utilization of blood products. That’s one conclusion from a newly-published study done at New York’s Icahn School of Medicine at Mount Sinai. If so, this is a technology improvement that would be welcomed by blood bankers and clinical laboratory managers who must manage the cost and utilization of blood products.

There’s no way around it—blood is expensive. A typical 400- to 600-bed hospital likely budgets upwards of one million dollars annually just for blood products. Almost universally, in hospitals the medical laboratory manages the blood bank. This is where medical technologists trained in blood banking test patients and test blood to ensure whole blood units, or other blood products such as platelets, match and will not trigger a negative reaction when administered to the patient.

When left unmanaged, the cost and utilization of blood bank products can put the budgets of hospital medical laboratories in the red. Hospitals also invest a great deal of money training surgeons to accurately assess the procedure and order the correct amount of blood components prior to surgery.

Therefore, new artificial intelligence (AI) technology that helps pinpoint patients’ blood loss during childbirth will be of interest to blood bankers and hospital laboratory administrators.

Can AI Help Clinical Labs Improve Utilization of Blood Products in Hospitals?

Physicians at the Icahn School of Medicine at Mount Sinai recently investigated whether “Quantifying blood loss” would improve the use of blood during human childbirth. They published the results of their study in the International Journal of Obstetric Anesthesia.

Their research into 7,618 deliveries (vaginal and cesarean) involved “An observational study comparing blood loss, management, and outcomes between two historical cohorts (August 2016 to January 2017 and August 2017 to January 2018) at an academic tertiary care center. Patients in the intervention group (second period) had blood loss quantified compared with visual estimation for controls,” the research paper notes.

The researchers concluded that “Quantifying blood loss may result in increased vigilance for vaginal and cesarean delivery. We identified an association between quantifying blood loss and improved identification of postpartum hemorrhage, patient management steps, and cost savings.”

The researchers, according to a press release, employed the Triton AI-enabled platform from Gauss Surgical, a silicon valley-based health technology company, to “monitor blood loss in all deliveries (vaginal and cesarean, n=3807) at Mount Sinai Hospital from August 2017 through January 2018 to support the institution’s stage-based hemorrhage protocol.”

The researchers found that use of a monitoring system was associated with earlier postpartum hemorrhage intervention and annual cost savings of $172,614 in lab costs and $36,614 in blood bank costs.

Daniel Katz, MD (above), Director of Obstetric Anesthesia Research and Associate Professor Anesthesiology, Perioperative and Pain Medicine, at Mount Sinai Hospital in New York, said in the news release, “This study demonstrates that efficiently obtaining accurate, real-time blood loss information is critical to the successful implementation of a stage-based hemorrhage protocol.” Katz was the study’s lead author. (Photo copyright: Mount Sinai Hospital.)

Measuring Blood Loss: The Eye versus AI

Gauss has secured Food and Drug Administration (FDA) clearance for Triton and more than 50 US hospitals are using it. Triton provides, in real-time, images of blood-saturated surgical sponges and canisters and uses computer vision and machine learning to pinpoint blood loss, reported MD+DI.

Traditionally, physicians visually estimate blood loss during procedures. When they are off in their estimates of postpartum hemorrhage, harmful postpartum health complications and deaths can occur, the Mount Sinai researchers explained in their paper.

And although other vital signs—heart rate, rhythm, blood pressure, oxygen level, etc.— are monitored with equipment in the surgical suite, blood usage is not. 

“Blood loss in surgery has been an enigma for decades since the dawn of medicine,” Siddarth Satish, Founder and Chief Executive Officer of Gauss, told MD+DI. “We monitor many other vital signs in surgery, but ultimately there hasn’t been any direct indicator of a patient’s hemoglobin loss.”

Bleeding Better Recognized, Less Blood Transfusions

After the Mount Sinai researchers used the Triton system to monitor blood loss during 3,807 vaginal and cesarean deliveries from August 2017 to January 2018 at Mount Sinai Hospital, they compared their findings to 3,811 deliveries from August 2016 to January 2017, during which doctors relied solely on visual estimation of blood loss.

The study found the following, according to the news release:

  • Improved hemorrhage recognition in vaginal deliveries of 2.2% and cesarean sections of 12.6% compared to .5% and 6.4%, respectively;
  • Less blood transfusions needed (vaginal patients): 47% with Triton compared to 71%;
  • Reduced blood transfusion dose (cesarean section): 1.90 units with Triton compared to 2.52 units;
  • Cost savings: $209,228 a year (the total of aforementioned lab and blood bank costs).

“What we like about [Gauss] is that it somewhat embodies precision medicine in the sense that you’re using more precise tools of measurement in their first use case,” Garrett Vygantas, MD, MBA, Managing Director for OSF Ventures, the financing arm of OSF Healthcare, who also serves on Gauss Surgical’s board, told MD+DI.

Possible New Resource for Hospital Medical Laboratories

So, will AI quickly become an omnipresent overseer in surgical suites? Hardly. However, AI is in the early stages of finding places in healthcare where it can be useful.  “A lot of people are predicting that AI will play a huge role in healthcare … I think it’ll be ever-present. There will be a little bit of AI in everything you’re doing, but I think the actual practice of medicine in its truest form is going to carry forward,” Satish told Fierce Healthcare.

Hospital medical laboratories and blood blanks looking for new tools to manage blood use may want to look into AI-enabled systems like Triton. Saving money is not the only benefit. Less transfused blood is better for patient care as well. 

—Donna Marie Pocius

Related Information:

New Publication Concludes Gauss Surgical’s Triton System Associated with Earlier Postpartum Hemorrhage Intervention and Reduced Costs

The Association Between the Introduction of Quantitative Assessment of Postpartum Blood Loss and Institutional Changes in Clinical Practice: An Observational Study

Gauss Uses AI to Accurately Measure Blood Loss

Clinical Experience with the Implementation of Accurate Measurement of Blood Loss During Cesarean Delivery: Influences on Hemorrhage Recognition and Allogeneic Transfusion

Special Report: Gauss Surgical

Gauss Raises $20 Million in Series C from Northwell Health and Softbank Ventures Korea for AI-Enabled Platform for the Operating Room

Federal Investigations into Alleged Kickback Schemes between Hospitals and Physicians Increase in Number and Scope

Hospitals and other organizations are finding ways to pay physicians for referrals in ways that don’t always look like kickbacks

Hospitals nationwide are being scrutinized by the federal Office of the Inspector General (OIG) for allegedly violating federal anti-kickback statutes. This will be of interest to clinical pathology laboratories that have been under a similar spotlight for various referral-kickback schemes and arrangements in the last few years, which Dark Daily repeatedly covered.

Kaiser Health News (KHN) recently reported on investigations by the OIG into hospitals allegedly offering unusually high salaries and other perks to specialists because they attract highly profitable business.

In the KHN article, titled, “Hospitals Accused of Paying Doctors Large Kickbacks in Quest for Patients,” Senior Correspondent Jordan Rau describes one investigation of salaries that involved certain high-profile specialists at Wheeling Hospital, in Wheeling, W.Va.

Wheeling, KHN reported, paid one anesthesiologist $1.2 million per year, which, Rau notes, is higher than the salaries of 90% of the pain management specialists around the country. Rau went on to describe how Wheeling also paid one obstetrician-gynecologist $1.3 million per year, and a cardiothoracic surgeon $770,000 per year along with 12 weeks of vacation time.

In each of those cases, the whistleblower who prompted the qui tam investigation reported that the specialists’ various departments were frequently in the red, reported KHN.

“The problem, according to the government, is that the efforts run counter to federal self-referral bans and anti-kickback laws that are designed to prevent financial considerations from warping physicians’ clinical decisions,” wrote Rau.

Wheeling not only contests the lawsuits brought against it, but also has filed a countersuit against the whistleblower. KHN said the hospital claims “its generous salaries were not kickbacks but the only way it could provide specialized care to local residents who otherwise would have to travel to other cities for services such as labor and delivery that are best provided near home.”

“We are confident that, if this case goes to a trial, there will be no evidence of wrongdoing—only proof that Wheeling Hospital offers the Northern Panhandle Community access to superior care, [and] world class physicians and services,” KHN reported Gregg Warren (above), Vice President of Marketing and Public Relations at Wheeling Hospital, saying in a statement. (Photo copyright: LinkedIn.)

OIG’s Fraud and Abuse Laws: A Roadmap for Physicians

The KHN article mentions five laws the OIG lists on its website that are particularly important for physicians to be aware of. They include the:

  • False Claims Act: states that it’s illegal to file false Medicare or Medicaid claims.
  • Anti-Kickback Statute: states that paying for referrals is illegal, that physicians can’t provide free or discounted services to uninsured people, and that money and gifts from drug and device makers to physicians are prohibited.
  • Stark Law(physician self-referral): says that referrals to entities with whom the physician has a familial or financial relationship are off-limits.
  • Exclusion Statue: describes who cannot participate in federal programs, such as Medicare.
  • Civil Monetary Penalties Law: authorizes the Secretary of Health and Human Services, which operates the OIG, to impose penalties in cases of fraud and abuse that involve Medicare or Medicaid.

“Together, these rules are intended to remove financial incentives that can lead doctors to order up extraneous tests and treatments that increase costs to Medicare and other insurers and expose patients to unnecessary risks,” KHN said.

Other Hospitals Under Investigation

Wheeling Hospital is not the only healthcare institution facing investigation. The Dallas Morning News (DMN) reported on a case involving Forest Park Medical Center (FPMC) in Dallas that resulted in the conviction of seven defendants, including four doctors. Prosecutors outlined the scheme in court, saying that FPMC illegally paid for surgeries.

“Prosecutors said the surgeons agreed to refer patients to the Dallas hospital in exchange for money to market their practices,” DMN reported, adding “Patients were a valuable commodity sold to the highest bidder, according to the government.” 

One of the convicted physicians, Michael Rimlawi, MD, told DMN, “I’m in disbelief. I thought we had a good system, a fair system.” His statement may indicate the level to which some healthcare providers at FPMC did not clearly understand how anti-kickback laws work.

“The verdict in the Forest Park case is a reminder to healthcare practitioners across the district that patients—not payments—should guide decisions about how and where doctors administer treatment,” US Attorney Erin Nealy Cox told DMN.

Know What Is and Is Not a Kickback

Both the Wheeling Hospital investigation and the Forest Park Medical Center case make it clear that kickbacks don’t always look like kickbacks. Becker’s Hospital Review published an article titled “Four Biggest Anti-Kickback Settlements Involving Hospitals in 2018” that details cases in which hospitals chose to settle.

These four incidents involved hospitals in Tennessee, Montana, Pennsylvania, and New York. This demonstrates that kickback schemes take place nationwide. And they show that violations of the Stark Law, the False Claims Act, and the Anti-Kickback Statute can happen in numerous ways.

Whether in a clinical laboratory or an enterprisewide health network, violating laws written to prevent money—rather than appropriate patient care—from being the primary motivator in hiring decisions, may result in investigation, charges, fines, and even conviction.

“If we’re going to solve the healthcare pricing problem, these kinds of practices are going to have to go away,” Vikas Saini, MD, President of the Lown Institute, a Massachusetts nonprofit that advocates for affordable care, told KHN.

Though these recent OIG investigations target hospitals, clinical laboratory leaders know from past experience that they also must be vigilant and ensure their hiring practices do not run afoul of anti-kickback legislation.

—Dava Stewart

Related Information:

Hospitals Accused of Paying Doctors Large Kickbacks in Quest for Patients

A Roadmap for New Physicians: Fraud and Abuse Laws

Surgeons, hospital owner convicted in massive kickback scheme involving Forest Park Medical Center

Four Biggest Anti-Kickback Settlements Involving Hospitals in 2018

Clinical Laboratory Compliance Practices Under Pressure as Federal Spotlight Is Aimed at Common Fraud and Abuse Schemes; Penalties for Violations Surge

Biodiagnostic Laboratory Services Leaders Sentenced to Prison in $100-Million Lab Test Kickback Scheme That Also Led to Convictions of 38 Physicians Does New Opioid Law Require Clinical Laboratories to Change How They Pay Sales Employees?

Payer-Provider Partnerships Accelerating as Insurers and Healthcare Networks Look to Improve Care Quality and Reduce Costs

Shift from fee-for-service to value-based reimbursement is fueling increase in joint ventures and co-branded insurance products, creating opportunities for nimble clinical laboratories and anatomic pathology groups

As healthcare moves from fee-for-service to value-based reimbursement, health insurers and providers are joining forces at a steadily increasing rate, with nearly three-quarters of partnered products in early 2018 being joint ventures or fully co-branded insurance products. This trend presents an opportunity for clinical laboratories to help providers become more effective in their use of laboratory tests as they aim for better patient outcomes and lower treatment costs.

While health systems integrating with insurance services is not new, the roll out of the Affordable Care Act (ACA) in 2014 and its emphasis on value-based reimbursement helped create renewed interest in vertical integration, notes Becker’s Hospital Review.

According to consulting firm Oliver Wyman, the number of payer-provider partnerships has grown rapidly over the past six years, with 73% of the 22 insurance products launched in the first quarter of 2018 being joint ventures of co-branded offerings.

In comparison:

  • 22% of partnerships were joint ventures or co-branded in 2014:
  • 33% in 2015;
  • 57% in 2016; and,
  • 71% last year.

Of the 22 new payer-provider partnerships announced this year, 20 product announcements explicitly emphasized value-based compensation, while compensation was implied but not mentioned in the final two product-based partnerships.

“Payers and providers continue to be interested in forming product-based partnerships,” Oliver Wyman stated when releasing the new data. “Our analysis … continues to show a steady increase of trend toward deeper partnership, with more co-branding, greater levels of value-based financial alignment, and other forms of closer collaboration and joint ventures.”

Oliver Wyman cited several “notable” new entrants:

In addition, Oliver Wyman noted that national payers Aetna and Cigna added to their growing rosters of joint ventures in 2018.

Speaking with Healthcare Dive, Tom Robinson, Partner, Health and Life Sciences at Oliver Wyman, described this year’s new ventures as varying in type, size, location, and model. He noted that 50/50 joint ventures with co-branding have gained in popularity, however, accountable care organizations (ACOs), pay-for-performance, and bundled-payment models also are being formed. Robinson believes these vertical integrations offer opportunities for innovation.

“The point of these partnerships is to create something new, rather than just building the same old offerings with a narrow network,” Robinson said. “Successful partnerships will take the opportunity to innovate around the product and experience now that the incentives, insight, investment and integration are all for it.”

Oliver Wyman Health and Life Sciences Partner Tom Robinson discusses the emerging trend of payer-provider partnerships

In the video above, Oliver Wyman Health and Life Sciences Partner Tom Robinson discusses the emerging trend of payer-provider partnerships, and he highlights unique challenges and opportunities of these joint ventures. Click here to watch the video. (Photo and caption copyright: Oliver Wyman.)

Lower Costs, Improved Access, Through Payer-Provider Partnerships

In announcing Blue Cross Blue Shield of Rhode Island (BCBSRI), and Lifespan’s launch of coordinated healthcare plan BlueCHiP Direct Advance, BCBSRI President and Chief Executive Kim Keck pointed to the plan’s ability to drive down healthcare costs.

“We hear a consistent theme from our members—they want more affordable health plan options—and through our collaboration with Lifespan we are doing that,” Keck stated in a news release. “BlueCHiP Direct Advance is an innovative product that features Lifespan’s vast network of providers who are positioned to more effectively manage and coordinate a patient’s care. And, our partnership allows us to offer this new product at a cost that is 10% lower than our comparable plans.”

When Allina Health System of Minnesota and Aetna last year announced their partnership plans, Allina Chief Executive Penny Wheeler, MD, praised the ability of “payer-provider” partnerships to improve care coordination and increase access to preventive care.

Jim Schowalter, MPP, President and Chief of Executive of the Minnesota Council of Health Plans, told the Star Tribune the joint venture between the for-profit insurer and local health system would accelerate the shift within the state to value-based care.

“This is another effort in our state that moves us away from old fee-for-service systems,” Schowalter stated. “Working together, doctors and insurers can deliver better personal care and hold down medical expenses.”

While the future of the ACA and other healthcare reforms is uncertain, clinical laboratories and anatomic pathology groups should expect healthcare networks and insurers to continue to find ways of partnering. That means pathologists can expect to have an expanded role in helping providers improve patient outcomes and reduce healthcare spending.

—Andrea Downing Peck

Related Information:

Analysis: Payers and Providers Continue to Partner

Providers Becoming Payors: Should Hospitals Start Their Own Health Plans?

Payer-provider Partnerships on Record Pace

Blue Cross and Blue Shield of Rhode Island and Lifespan Partner to Bring Lower Cost Option to Rhode Island Residents in 2018

Security Health Plan Adds Mayo Clinic Health System to Provider Network

New Partnership Expands WellCare Members’ Access to UNC Health Alliance

Allina Health and Aetna to Launch Insurance Company in Minnesota

Helping Medical Laboratories Add Value to Health Systems, Providers, and Payers by Moving from Clinical Lab 1.0 to Clinical Lab 2.0

November workshop to teach Clinical Lab 2.0 to forward-thinkers among clinical laboratories, IVD manufacturers, and lab IT vendors offered many examples where clinical laboratory diagnostics can add value and improve patient outcomes

DATELINE: ALBUQUERQUE, New Mexico—Here in this mile-high city, a special Project Santa Fe Workshop devoted to teaching the principles of Clinical Lab 2.0 attracted an impressive roster of innovators and forward-thinkers in clinical laboratory medicine. In attendance were leaders from a select number of the nation’s first-rank health systems and hospitals, along with executives from In Vitro diagnostics (IVD) manufacturers, lab IT companies, other lab service companies, attendees from the Centers for Disease Control and Prevention, and from institutions in Canada, Germany, Israel, India, and the UK.

Their common goal was to learn more about the emerging clinical and business model for medical laboratories known as “Clinical Lab 2.0.” A key objective of the workshop was to help those lab leaders in attendance develop strategic action plans for their own lab organizations, so as to take advantage of the insights coming from the vast information streams generated by their clinical laboratories. These services would be in support the evolving needs of health systems, hospitals physicians, and health insurers to more effectively provide integrated patient-centered clinical care.

Medical Laboratories Can Use Clinical Lab 2.0 as a Path to Adding Value

Clinical Lab 2.0 is the clinical and business model of the future for medical laboratories, assert the developers of this concept. “Clinical Lab 2.0 describes the attributes needed by all medical laboratories that want to succeed in a healthcare system organized to provide precision medicine, keep people out of hospitals, and where providers—including labs—are reimbursed based on the value they provide,” stated Khosrow Shotorbani, CEO of TriCore Reference Laboratories, one of the organizers of the Project Santa Fe Clinical Lab 2.0 Workshop.

“Clinical Lab 2.0 is the path medical labs will need to follow if they are to continue providing relevant lab testing services and generate the reimbursement necessary for them to maintain a high level of clinical excellence and financial stability going forward,” he added. “This is the next generation of medical laboratory organization and operation.”

Lab 1.0 Was Lab Clinical/Business Model for 50 Years

For more than 50 years, Clinical Lab 1.0 was the model for labs,” noted James Crawford, MD, PhD, Executive Director and Senior Vice President of Laboratory Services at Northwell Health Laboratories and an organizer of the Project Santa Fe Clinical Lab 2.0 Workshop. “Lab 1.0 is transactional, focusing on generating high quality analytical data on specimens received, but without assembling these data into integrative clinical care programs. In the simplest sense, Clinical Lab 1.0 focused on generating ever-greater numbers of specimens to drive down average cost-per-test, while maximizing revenue in a fee-for-service system.

This chart shows the attributes of Clinical Lab 1.0 and compares those to the attributes of Clinical Lab 2.0. Lab 1.0 is transactional and based on increasing test volume to lower costs and maximize fee-for-service revenue. Clinical Lab 2.0 is integrative in ways that add value to lab testing services. (Graphic copyright Project Santa Fe.)

“But fee-for-service payment is going away,” he said. “Increasingly, clinical laboratories will be paid based on the value they provide. This payment can be in the form of bundled reimbursement, as a per-member-per-month payment, or as a share of the budgeted payment made to a health system, an accountable care organization (ACO), or a multispecialty provider network. As these alternative forms of provider payment become dominant, to earn a fair share of reimbursement, all medical laboratories will need a clinical strategy to deliver lab testing services that measurably contribute to improved patient outcomes while reducing the overall cost of care. This requires looking at medical laboratories’ contribution to effective delivery of the full dollar of the healthcare spend, not just the three-cents-on-the-dollar representing laboratory testing.”

Innovators in Clinical Laboratory Industry Identify New Ways to Add Value

There are already a handful of innovative clinical laboratory organizations that have clinical experience in moving past the Lab 1.0 paradigm of reporting an accurate test result within the accepted turnaround time. Leaders within these labs are collaborating with physicians and frontline care givers specifically to help them better utilize lab tests in ways that directly improve the speed and accuracy of the overall diagnostic sequence, as well as achieving therapeutic optimization as rapidly as possible. These collaborations are tracking the improvement in patient outcomes while demonstrating how better use of lab tests can lower the total cost per episode of care.

During the Clinical Lab 2.0 workshop, case studies were presented demonstrating how clinical laboratory leaders are taking the first steps to practice Clinical Lab 2.0 so as to achieve added value with medical laboratory tests. The case studies included:

·       A project to improve diagnosis and treatment of sepsis at Geisinger Health System.

·       A project at Henry Ford Health to collaborate with physicians to more appropriately utilize lab tests and build consensus in support of a new lab test formulary.

·       A multi-hospital initiative at Northwell Health to collaborate with physicians and nurses in the use of creating testing to make earlier, more accurate diagnoses of acute kidney injury during inpatient admissions, and better guide decisions to treat.

·       A partnership involving TriCore Reference Laboratory and certain health insurers in New Mexico where the laboratory—using lab test data (some generated by emergency room testing) and other clinical data—alerts the insurers to women who are pregnant, thus allowing the insurers to provide timely guidance to the women’s care teams with the goal of improving prenatal care.

The Project Santa Fe Clinical Lab 2.0 Workshop convened on November 13-14 in Albuquerque, N.M. A broad spectrum of innovative professionals from the five Project Santa Fe member laboratories (above) were there to teach the lessons learned from their first successful efforts to collaborate with physicians and create added value from medical laboratory diagnostics. Other attendees included progressive lab leaders from several of the nation’s most prominent health systems, along with thought leaders from the IVD, lab software, and lab association sectors. (Photo copyright Project Santa Fe.)

Project Santa Fe Workshop: A Well-Attended Lab ‘Think Tank’

Participants attending the Clinical Lab 2.0 workshop included hospital lab administrators, pathologists, and clinical laboratory industry executives. The importance of this workshop is reflected in the educational grants and financial support provided by leading in vitro diagnostics manufacturers, lab IT companies, and other lab industry vendors. The lab industry vendors included:

·       Abbott Laboratories

·       ARUP Laboratories

·       Beckman Coulter

·       DiaSorin

·       MedSpeed

·       Roche Diagnostics

·       Siemens Healthineers

·       Sysmex

Also providing educational grants and similar support were:

·       American Clinical Laboratory Association

·       CAP Today

·       Centers for Disease Control and Prevention

·       Mayo Medical Laboratories

·       The Dark Report

Project Santa Fe was launched in 2016 by clinical lab leaders from five of the nation’s most respected integrated health systems:

·       TriCore Reference Laboratories;

·       Henry Ford Health;

·       Geisinger Health;

·       Kaiser Permanente Northern California; and,

·       Northwell Health.

Described as a think-tank venture, the organizers are committed to implementing projects that demonstrate how lab tests can be used in ways that add value, and then publish the resulting projects, along with data about improved patient outcomes and reductions in healthcare costs, in peer-reviewed journals. Multi-institutional studies will be required to validate the findings and outcomes from the added-value clinical collaborations initiated at the different medical laboratory organizations participating in Project Santa Fe.

Another primary goal is to share the lessons learned from these innovative projects with other like-minded pathologists, lab administrators, and lab managers. In May, Project Santa Fe organizers led a one-day workshop to teach Clinical Lab 2.0 at the Executive War College on Laboratory and Pathology Management. The workshop in Albuquerque on November 13-14 was the second learning opportunity available to medical laboratory professionals. A November 2018 workshop is planned.

—Robert L. Michel

Related Information:

Project Santa Fe Workshop

Improving American Healthcare through “Clinical Lab 2.0”: A Project Santa Fe Report

Laboratory 2.0: Changing the Conversation

CEO Describes Characteristics of the Clinical Lab 2.0 Model: Five Health System Labs Using Project Santa Fe To Demonstrate Value

Moving to Clinical Lab 2.0: Deliver More Value! Get Paid More Dollars!

Lab Innovators Advocate Need for Clinical Lab 2.0: Lab 1.0 Is the Low-Paid Commodity Lab, While Lab 2.0 Gets Paid More for the Value It Contributes

Using the Laboratory Value Pyramid and Clinical Lab 2.0 to Position Your Lab to Add Value in the Era of Population Health, Precision Medicine, and Value-Based Payment

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