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

Hosted by Robert Michel

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

Hosted by Robert Michel
Sign In

Florida Hospital Utilizes Machine Learning Artificial Intelligence Platform to Reduce Clinical Variation in Its Healthcare, with Implications for Medical Laboratories

Pathologists and clinical laboratory scientists may find one hospital’s use of a machine-learning platform to help improve utilization of lab tests both an opportunity and a threat

Variation in how individual physicians order, interpret, and act upon clinical laboratory test results is regularly shown by studies in peer-reviewed medical journals to be one reason why some patients get great outcomes and other patients get less-than-desirable outcomes. That is why many healthcare providers are initiating efforts to improve how physicians utilize clinical laboratory tests and other diagnostic procedures.

At Flagler Hospital, a 335-bed not-for-profit healthcare facility in St. Augustine, Fla., a new tool is being used to address variability in clinical care. It is a machine learning platform called Symphony AyasdiAI for Clinical Variation Management (AyasdiAI) from Silicon Valley-based SymphonyAI Group. Flagler is using this system to develop its own clinical order set built from clinical data contained within the hospital’s electronic health record (EHR) and financial systems.

This effort came about after clinical and administrative leadership at Flagler Hospital realized that only about one-third of its physicians regularly followed certain medical decision-making guidelines or clinical order sets. Armed with these insights, staff members decided to find a solution that reduced or removed variability from their healthcare delivery.

Reducing Variability Improves Care, Lowers Cost

Variability in physician care has been linked to increased healthcare costs and lower quality outcomes, as studies published in JAMA and JAMA Internal Medicine indicate. Such results do not bode well for healthcare providers in today’s value-based reimbursement system, which rewards increased performance and lowered costs.

“Fundamentally, what these technologies do is help us recognize important patterns in the data,” Douglas Fridsma, PhD, an expert in health informatics, standards, interoperability, and health IT strategy, and CEO of the American Medical Informatics Association (AMIA), told Modern Healthcare.

Clinical order sets are designed to be used as part of clinical decision support systems (CDSS) installed by hospitals for physicians to standardize care and support sound clinical decision making and patient safety.

However, when doctors don’t adhere to those pre-defined standards, the results can be disadvantageous, ranging from unnecessary services and tests being performed to preventable complications for patients, which may increase treatment costs.

“Over the past few decades we’ve come to realize clinical variation plays an important part in the overuse of medical care and the waste that occurs in healthcare, making it more expensive than it should be,” Michael Sanders, MD (above) Flagler’s Chief Medical Information Officer, told Modern Healthcare. “Every time we’re adding something that adds cost, we have to make sure that we’re adding value.” (Photo copyright: Modern Healthcare.)

Flagler’s AI project involved uploading clinical, demographic, billing, and surgical information to the AyasdiAI platform, which then employed machine learning to analyze the data and identify trends. Flagler’s physicians are now provided with a fuller picture of their patients’ conditions, which helps identify patients at highest risk, ensuring timely interventions that produce positive outcomes and lower costs.

How Symphony AyasdiAI Works

The AyasdiAI application utilizes a category of mathematics called topological data analysis (TDA) to cluster similar patients together and locate parallels between those groups. “We then have the AI tools generate a carepath from this group, showing all events which should occur in the emergency department, at admission, and throughout the hospital stay,” Sanders told Healthcare IT News. “These events include all medications, diagnostic tests, vital signs, IVs, procedures and meals, and the ideal timing for the occurrence of each so as to replicate the results of this group.”

Caregivers then examine the data to determine the optimal plan of care for each patient. Cost savings are figured into the overall equation when choosing a treatment plan. 

Flagler first used the AI program to examine trends among their pneumonia patients. They determined that nebulizer treatments should be started as soon as possible with pneumonia patients who also have chronic obstructive pulmonary disease (COPD).

“Once we have the data loaded, we use [an] unsupervised learning AI algorithm to generate treatment groups,” Sanders told Healthcare IT News. “In the case of our pneumonia patient data, Ayasdi produced nine treatments groups. Each group was treated similarly, and statistics were given to us to understand that group and how it differed from the other groups.”

Armed with this information, the hospital achieved an 80% greater physician adherence to order sets for pneumonia patients. This resulted in a savings of $1,350 per patient and reduced the readmission rates for pneumonia patients from 2.9% to 0.4%, reported Modern Healthcare.

The development of a machine-learning platform designed to reduce variation in care (by helping physicians become more consistent at following accepted clinical care guidelines) can be considered a warning shot across the bow of the pathology profession.

This is a system that has the potential to become interposed between the pathologist in the medical laboratory and the physicians who refer specimens to the lab. Were that to happen, the deep experience and knowledge that have long made pathologists the “doctor’s doctor” will be bypassed. Physicians will stop making that first call to their pathologists, clinical chemists, and laboratory scientists to discuss a patient’s condition and consult on which test to order, how to interpret the results, and get guidance on selecting therapies and monitoring the patient’s progress.

Instead, a “smart software solution” will be inserted into the clinical workflow of physicians. This solution will automatically guide the physician to follow the established care protocol. In turn, this will give the medical laboratory the simple role of accepting a lab test order, performing the analysis, and reporting the results.

If this were true, then it could be argued that a laboratory test is a commodity and hospitals, physicians, and payers would argue that they should buy these commodity lab tests at the cheapest price.

—JP Schlingman

Related Information:

Flagler Hospital Combines AI, Physician Committee to Minimize Clinical Variation

Flagler Hospital Uses AI to Create Clinical Pathways That Enhance Care and Slash Costs

Case Study: Flagler Hospital, How One of America’s Oldest Cities Became Home to One of America’s Most Innovative Hospitals

How Using Artificial Intelligence Enabled Flagler Hospital to Reduce Clinical Variation

Florida Hospital to Save $20M Through AI-enabled Clinical Variation

The Journey from Volume to Value-Based Care Starts Here

The Science of Clinical Carepaths

New Value-Based Payment Model for Oncology Care Could Affect How Pathologists and Medical Laboratories Get Paid for Their Services

Centers for Medicare and Medicaid Innovation is considering adding clinical laboratory services to bundled payments in its proposed Oncology Care First model

Anatomic pathologists, surgical pathologists, and medical laboratories could find some of their services shifted to a bundled payment scheme as the Center for Medicare and Medicaid Innovation (CMMI) considers a new value-based alternative payment model (APM) for providers of cancer care.

CMMI, an organization within the Centers for Medicare and Medicaid Services (CMS), is charged with developing and testing new healthcare delivery and payment models as alternatives to the traditional fee-for-service (FFS) model. On November 1, 2019, CMMI released an informal Request for Information (RFI) seeking comments for the proposed Oncology Care First (OCF) model, which would be the successor to the Oncology Care Model (OCM) launched in 2016.

“The inefficiency and variation in oncology care in the United States is well documented, with avoidable hospitalizations and emergency department visits occurring frequently, high service utilization at the end of life, and use of high-cost drugs and biologicals when lower-cost, clinically equivalent options exist,” the CMMI RFI states.

With the proposed new model, “the Innovation Center aims to build on the lessons learned to date in OCM and incorporate feedback from stakeholders,” the RFI notes.

How the Oncology Care First Model Works

The OCF program, which is voluntary, will be open to physician groups and hospital outpatient departments. CMMI anticipates that testing of the model will run from January 2021 through December 2025.

It will offer two payment mechanisms for providers that choose to participate:

  • A Monthly Population Payment (MPP) would apply to a provider’s Medicare beneficiaries with “cancer or a cancer-related diagnosis,” the RFI states. It would cover Evaluation and Management (EM) services as well as drug administration services and a set of “Enhanced Services,” including 24/7 access to medical records.

Of particular interest to medical laboratories, the RFI also states that “we are considering the inclusion of additional services in the monthly population payment, such as imaging or medical laboratory services, and seek feedback on adding these or other services.”

  • In addition, providers could receive a Performance-Based Payment (PBP) if they reduce expenditures for patients receiving chemotherapy below a “target amount” determined by past Medicare payments. If providers don’t meet the threshold, they could be required to repay CMS.

CMMI initially announced the public listening session and set a Nov. 25 deadline for written feedback, then extended it to Dec. 13, 2019. The feedback period is now closed.

Practices that wish to participate in the OCF model must go through an application process. It is also open to participation by private payers. CMS reports that 175 practices and 10 payers are currently participating in the 2016 Oncology Care Model (OCM).

“We want better quality care for patients,” explained Lara Strawbridge, MPH (above), Director of the CMMI Division of Ambulatory Payment Models, during a US Department of Health and Human Services public listening session on Nov. 8. “We hope that at the same time, costs are maintained or reduced.” The new OCF payment model will feature a Monthly Population Payment mechanism that could include reimbursements for medical laboratory services, which has some medical laboratory organizations concerned. (Photo copyright: Center for Medicare and Medicaid Innovation.)

Medical Lab Leaders Concerned about the CMMI OCF Model

One group raising concerns about the inclusion of medical laboratory service reimbursements in the Monthly Population Payment scheme is the Personalized Medicine Coalition. “Laboratory services are crucial to the diagnosis and management of many cancers and are an essential component of personalized medicine,” wrote Cynthia A. Bens, the organization’s senior VP for public policy, in an open letter to CMMI Acting Director Amy Bassano. “We are concerned that adding laboratory service fees to the MPP may cause providers to view them as expenses that are part of the total cost of delivering care, rather than an integral part of the solution to attain high-value care,” Bens wrote.

She advised CMMI to “seek further input from the laboratory and provider communities on how best to contain costs within the OCF model, while ensuring the proper deployment of diagnostics and other laboratory services.”

Members of the coalition include biopharma companies, diagnostic companies, patient advocacy groups, and clinical laboratory testing services. Lab testing heavyweights Quest Diagnostics (NYSE:DGX) and Laboratory Corporation of America (NYSE:LH) are both members.

CMS ‘Doubles Down’ on OCM

The proposal received criticism from other quarters as well. “While private- and public-sector payers would be well served to adopt and support a VBP [value-based payment] program for cancer care, we need to better understand some of the shortcomings of the original OCM design and adopt lessons learned from other successful VBP models to ensure uptake by providers and ultimately better oncology care for patients,” wrote members of the Oncology Care Model Work Group in a Health Affairs blog post. They added that with the new model, “CMS seems to double down on the same design as the OCM.”

Separately, CMMI has proposed a controversial Radiation Oncology (RO) alternative payment model (APM) that would be mandatory for practices in randomly-selected metro areas. The agency estimates that it would apply to approximately 40% of the radiotherapy practices in the US.

The RO APM was originally set to take effect this year, but after pushback from industry groups, CMS delayed implementation until July 18, 2022, Healthleaders Media reported.

These recent actions should serve to remind pathologists and clinical laboratories that CMS continues to move away from fee-for-service and toward value-based care payment models, and that it is critical to plan for changing reimbursement strategies.

—Stephen Beale

Related Information:

Oncology Care First: What You Need to Know about the Proposed Oncology Care First

Redesigning Oncology Care: A Look at CMS’ Proposed Oncology First Model

CMS, CMMI Seek Feedback on Oncology Care First, Successor to OCM

We Need Better Quality Measures for Oncology Care First

What You Should Know about the Proposed Oncology Care First Model

Oncology Care First Resource Hub

ACR Expresses Concerns about Potential Oncology Care First Payment Model

Redesigning the Oncology Care Model

ACR Wants CMS Radiation Oncology Model Delayed

ASTRO Calls for Voluntary Start, Scaling Back Excessive Cuts in CMS’ Proposed Radiation Oncology Model

Mandatory CMS Radiation Oncology Model Goes on the Backburner

Machine Learning System Catches Two-Thirds More Prescription Medication Errors than Existing Clinical Decision Support Systems at Two Major Hospitals

Researchers find a savings of more than one million dollars and prevention of hundreds, if not thousands, of adverse drug events could have been had with machine learning system

Support for artificial intelligence (AI) and machine learning (ML) in healthcare has been mixed among anatomic pathologists and clinical laboratory leaders. Nevertheless, there’s increasing evidence that diagnostic systems based on AI and ML can be as accurate or more accurate at detecting disease than systems without them.

Dark Daily has covered the development of artificial intelligence and machine learning systems and their ability to accurately detect disease in many e-briefings over the years. Now, a recent study conducted at Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) suggests machine learning can be more accurate than existing clinical decision support (CDS) systems at detecting prescription medication errors as well.

The researchers published their findings in the Joint Commission Journal on Quality and Patient Safety, titled, “Using a Machine Learning System to Identify and Prevent Medication Prescribing Errors: A Clinical and Cost Analysis Evaluation.”

A Retrospective Study

The study was partially retrospective in that the researchers compiled past alerts generated by the CDS systems at BWH and MGH between 2009-2011 and added them to alerts generated during the active part of the study, which took place from January 1, 2012 to December 31, 2013, for a total of five years’ worth of CDS alerts.

They then sent the same patient-encounter data that generated those CDS alerts to a machine learning platform called MedAware, an AI-enabled software system developed in Ra’anana, Israel.

MedAware was created for the “identification and prevention of prescription errors and adverse drug effects,” notes the study, which goes on to state, “This system identifies medication issues based on machine learning using a set of algorithms with different complexity levels, ranging from statistical analysis to deep learning with neural networks. Different algorithms are used for different types of medication errors. The data elements used by the algorithms include demographics, encounters, lab test results, vital signs, medications, diagnosis, and procedures.”

The researchers then compared the alerts produced by MedAware to the existing CDS alerts from that 5-year period. The results were astonishing.

According to the study:

  • “68.2% of the alerts generated were unique to the MedAware system and not generated by the institutions’ CDS alerting system.
  • “Clinical outlier alerts were the type least likely to be generated by the institutions’ CDS—99.2% of these alerts were unique to the MedAware system.
  • “The largest overlap was with dosage alerts, with only 10.6% unique to the MedAware system.
  • “68% of the time-dependent alerts were unique to the MedAware system.”

Perhaps even more important was the results of the cost analysis, which found:

  • “The average cost of an adverse event potentially prevented by an alert was $60.67 (range: $5.95–$115.40).
  • “The average adverse event cost per type of alert varied from $14.58 (range: $2.99–$26.18) for dosage outliers to $19.14 (range: $1.86–$36.41) for clinical outliers and $66.47 (range: $6.47–$126.47) for time-dependent alerts.”

The researchers concluded that, “Potential savings of $60.67 per alert was mainly derived from the prevention of ADEs [adverse drug events]. The prevention of ADEs could result in savings of $60.63 per alert, representing 99.93% of the total potential savings. Potential savings related to averted calls between pharmacists and clinicians could save an average of $0.047 per alert, representing 0.08% of the total potential savings.

“Extrapolating the results of the analysis to the 747,985 BWH and MGH patients who had at least one outpatient encounter during the two-year study period from 2012 to 2013, the alerts that would have been fired over five years of their clinical care by the machine learning medication errors identification system could have resulted in potential savings of $1,294,457.”

Savings of more than one million dollars plus the prevention of potential patient harm or deaths caused by thousands of adverse drug events is a strong argument for machine learning platforms in diagnostics and prescription drug monitoring.

“There’s huge promise for machine learning in healthcare. If clinicians use the technology on the front lines, it could lead to improved clinical decision support and new information at the point of care,” said Raj Ratwani, PhD (above), Vice President of Scientific Affairs at MedStar Health Research Institute (MHRI), Director of MedStar Health’s National Center for Human Factors in Healthcare, and Associate Professor of Emergency Medicine at Georgetown University School of Medicine, told HealthITAnalytics. [Photo copyright: MedStar Institute for Innovation.)

Researchers Say Current Clinical Decision Support Systems are Limited

Machine learning is not the same as artificial intelligence. ML is a “discipline of AI” which aims for “enhancing accuracy,” while AI’s objective is “increasing probability of success,” explained Tech Differences.

Healthcare needs the help. Prescription medication errors cause patient harm or deaths that cost more than $20 billion annually, states a Joint Commission news release.

CDS alerting systems are widely used to improve patient safety and quality of care. However, the BWH-MGH researchers say the current CDS systems “have a variety of limitations.” According to the study:

  • “One limitation is that current CDS systems are rule-based and can thus identify only the medication errors that have been previously identified and programmed into their alerting logic.
  • “Further, most have high alerting rates with many false positives, resulting in alert fatigue.”

Alert fatigue leads to physician burnout, which is a big problem in large healthcare systems using multiple health information technology (HIT) systems that generate large amounts of alerts, such as: electronic health record (EHR) systems, hospital information systems (HIS), laboratory information systems (LIS), and others.

Commenting on the value of adding machine learning medication alerts software to existing CDS hospital systems, the BWH-MGH researchers wrote, “This kind of approach can complement traditional rule-based decision support, because it is likely to find additional errors that would not be identified by usual rule-based approaches.”

However, they concluded, “The true value of such alerts is highly contingent on whether and how clinicians respond to such alerts and their potential to prevent actual patient harm.”

Future research based on real-time data is needed before machine learning systems will be ready for use in clinical settings, HealthITAnalytics noted. 

However, medical laboratory leaders and pathologists will want to keep an eye on developments in machine learning and artificial intelligence that help physicians reduce medication errors and adverse drug events. Implementation of AI-ML systems in healthcare will certainly affect clinical laboratory workflows.

—Donna Marie Pocius

Related Information:

AI and Healthcare: A Giant Opportunity

Using a Machine Learning System to Identify and Prevent Medication Prescribing Errors:  A Clinical and Cost Analysis Evaluation

Machine Learning System Accurately Identifies Medication Errors

Journal Study Evaluates Success of Automated Machine Learning System to Prevent Medication Prescribing Errors

Differences Between Machine Learning and Artificial Intelligence

Machining a New Layer of Drug Safety

Harvard and Beth Israel Deaconess Researchers Use Machine Learning Software Plus Human Intelligence to Improve Accuracy and Speed of Cancer Diagnoses

XPRIZE Founder Diamandis Predicts Tech Giants Amazon, Apple, and Google Will Be Doctors of The Future

Hospitals Worldwide Are Deploying Artificial Intelligence and Predictive Analytics Systems for Early Detection of Sepsis in a Trend That Could Help Clinical Laboratories, Microbiologists

Employers Can Save Money by Adopting Self-funded Healthcare Models, and Clinical Laboratories Have Opportunities to Support These Plans

By negotiating directly with healthcare providers, employers cut health insurers out of the loop, at least for certain specified healthcare conditions and surgeries

It’s a new trend in how employers provide healthcare benefits for their employees. In order to save money, a growing number of employers are going to low-cost hospitals, physicians, and other providers to contract directly for their services. This may be the opening that allows some clinical laboratories to approach larger employers in their region and negotiate pricing and contract terms without the need to involve a health insurer.

What’s motivating more employers to reach out and contract directly with low-cost healthcare providers is the realization that their health insurance plan typically pays much more than Medicare to hospitals, physicians, clinical laboratories, and other ancillary providers. This fact is supported by a study conducted by the Rand Corporation that found “large employers generally lack useful information about the prices they are paying for healthcare services,” and that of the 1,600 hospitals in 25 states that Rand surveyed, “employer-sponsored health plans paid hospitals an average of 241% of what Medicare would have paid for the same inpatient and outpatient services in 2017,” which is up from 236% of Medicare in 2015, Modern Healthcare reported.

Thus, to better control the skyrocketing cost of healthcare, and the health benefits plan they offer their employees, employers are increasingly turning to self-coverage and implementing company benefits plans that reward employees for price shopping and for selecting the lowest costs healthcare services.

This trend is another reason why clinical laboratory leaders should be tracking changes in federal price transparency requirements, along with the increased consumer interest in accessing healthcare prices in advance of service.

Employers Negotiate Directly for Healthcare Services

Over the past decade, Dark Daily has repeatedly covered expanding federal price transparency legislation and the trend among large employers to self-insure and negotiate with hospital networks for discounted healthcare services for their employees. Most recently in, “Ohio Healthcare Network Serving Amish and Anabaptist Communities Could Provide Blueprint for Hospital Price Transparency,” and “Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing.”

Innovative employer plans to decrease healthcare costs include:

  • Contracting directly with medical providers,
  • Opening primary care clinics within their corporate facilities,
  • Referring employees to contracted providers for certain procedures, and
  • Creating bundled-payment deals with select providers.

Modern Healthcare reports that both public and private employers in five states (Colorado, Connecticut, Michigan, Montana, Texas, and Wisconsin) are “considering or launching group purchasing initiatives with narrow- or tiered-network plans, onsite primary-care clinics, and contracts with advanced primary-care providers,” as well as “direct-contracting with providers, such as referring employees to designated centers of excellence for some procedures and conditions under bundled-payment deals with warrantied results.”

Cheryl DeMars, CEO of The Alliance, a Wisconsin healthcare purchasing cooperative, says there is a movement afoot. “I’m seeing a level of boldness on the part of our members that I haven’t seen before in my 27 years here,” she told Modern Healthcare.

“Almost 100 million employees covered through self-insured plans not only represents a staggeringly large market for healthcare cost containment, it is an extraordinary opportunity for America to meaningfully reduce our national healthcare bill,” Kirk Fallbacher (above), President and CEO of Advanced Medical Pricing Solutions (AMPS) told Healthcare Finance News. (Photo copyright: NextGenRBP.com)

Self-insured Employers can Reduce the Nation’s Healthcare Bill, says KFF

A 2018 US Census Bureau report states that more than 181 million people in the US were enrolled in employer-sponsored health plans in 2017, and that the estimated average premium for employer-sponsored family coverage increased at an annual rate of 4.5% from 2008 to 2019.

That increase was approximately twice the rate of overall inflation and growth in average hourly earnings during the same time period, according to the report, which also states that the surge in premiums was driven by price increases for medical services and that use of most healthcare services among employees has actually been declining.

For US employers, “the steep increase in their healthcare cost crowds out financial resources that could be used for employee wage increases, capital investments, and other spending priorities, such as retirement plans,” the report notes.

However, an estimated 94 million of the 156 million workers in the US—approximately 61%—are currently covered under a self-insured medical plan through their employer, the KFF Employer Health Benefits 2019 Annual Survey states.

Healthcare.gov defines the self-insured health insurance plan as a “type of plan usually present in larger companies where the employer itself collects premiums from enrollees and takes on the responsibility of paying employees’ and dependents’ medical claims. These employers can contract for insurance services such as enrollment, claims processing, and provider networks with a third-party administrator, or they can be self-administered.”

Kirk Fallbacher, President and CEO of Advanced Medical Pricing Solutions (AMPS), told Healthcare Finance News (HFN) that the self-insured approach to employee medical coverage saves employers between 20% and 30% over a traditional Preferred Provider Organization (PPO), and that the savings total about $2,800 per person annually. 

“It doesn’t signal the end of the insurance industry,” he said. “On the cost side of the equation, the PPO approach is beginning to come to an end. The costs are outstripping inflation and wages.”

Moving to self-insurance is another part of the current trend for price transparency in the healthcare industry and may offer opportunities for clinical laboratories to increase profits. Clinical laboratories and anatomic pathology groups might want to contact the Human Resources Departments of local major employers to educate them on the costs and quality value of their labs. Such a proactive and innovative move could encourage employers to include those labs in the provider networks of their self-insured health benefit plans.   

—JP Schlingman

Related Information:

Self-insured Employers Go Looking for Value-based Deals

Self-insured Employers Are Playing An Increasing Role in Taking on The Status Quo to Lower Costs

Self-insured Employers Have More Leverage than They Think

Health Insurance Coverage in The United States: 2017

The Kaiser Family Foundation Employer Health Benefits 2019 Annual Survey

Ohio Healthcare Network Serving Amish and Anabaptist Communities Could Provide Blueprint for Hospital Price Transparency

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing

Medical Laboratories Need to Prepare as Public Health Officials Deal with Latest Coronavirus Outbreak

The CDC has developed a test kit, but deployment to public health laboratories has been delayed by a manufacturing defect

Medical laboratories are on the diagnostic front lines of efforts in the US to contain the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for the disease COVID-19, which was first reported in Wuhan City, China. SARS-CoV-2 differs from severe acute respiratory syndrome coronavirus (SARS-CoV), which caused an outbreak of severe acute respiratory syndrome (SARS) in 2003.

Currently, all testing for SARS-CoV-2 in the US is performed by the Centers for Disease Control and Prevention (CDC), using a CDC-developed rapid test known as the 2019-nCoV Real-Time RT-PCR Diagnostic Panel. But soon, testing will be performed by city and state public health (reference) laboratories as well.

At present, medical laboratories are collecting blood specimens for testing by authorized public health labs. However, clinical laboratories should prepare for the likelihood they will be called on to perform the testing using the CDC test or other tests under development.

“We need to be vigilant and understand everything related to the testing and the virus,” said Bodhraj Acharya, PhD, Manager of Chemistry and Referral Testing at the Laboratory Alliance of Central New York, in an exclusive interview with Dark Daily. “If the situation comes that you have to do the testing, you have to be ready for it.”

The CDC has set up a website with information about SARS-CoV-2 (COVID-19) including a section specifically for laboratory professionals. The “Information for Health Departments on Reporting a Person Under Investigation (PUI) or Laboratory-Confirmed Case for COVID-19” section includes guidelines for collecting, handling, and shipping specimens. It also has laboratory biosafety guidelines.

The current criteria for determining PUIs include clinical features, such as fever or signs of lower respiratory illness, combined with epidemiological risks, such as recent travel to China or close contact with a laboratory-confirmed COVID-19 patient. The CDC notes that “criteria are subject to change as additional information becomes available” and advises healthcare providers to consult with state or local health departments if they believe a patient meets the criteria.

Bodhraj Acharya, PhD (above), is Manager of Chemistry and Referral Testing at the Laboratory Alliance of Central New York. In an exclusive interview with Dark Daily, he stressed the importance that medical laboratories be prepared. “We need to be vigilant and be active and understand everything related to this virus and the testing. That’s the role of clinical laboratory scientists, to be ready because this can become a pandemic anytime. It can spread and tomorrow the CDC could announce it is disseminating the test to designated laboratories.” (Photo copyright: Laboratory Alliance of Central New York.)

Test Kit Problems Delay Diagnoses

On Feb. 4, the FDA issued a Novel Coronavirus Emergency Use Authorization (EUA) allowing state and city public health laboratories, as well as Department of Defense (DoD) labs, to perform presumptive qualitative testing using the Real-Time Reverse Transcriptase PCR (RT-PCR) diagnostic panel developed by the CDC. Two days later, the CDC began distributing the test kits, a CDC statement announced. Each kit could test 700 to 800 patients, the CDC said, and could provide results from respiratory specimens in four hours.

However, on Feb. 12, the agency revealed in a telebriefing that manufacturing problems with one of the reagents had caused state laboratories to get “inconclusive laboratory results” when performing the test.

“When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories,” said Nancy Messonnier, MD, Director of the CDC National Center for Immunization and Respiratory Diseases (NCIRD), during the telebriefing. “Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct.”

During a follow-up telebriefing on Feb. 14, Messonnier said that the CDC “is reformulating those reagents, and we are moving quickly to get those back out to our labs at the state and local public health labs.”

Above is a picture of CDC’s laboratory test kit for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). CDC is shipping the test kits to laboratories CDC has designated as qualified, including US state and local public health laboratories, Department of Defense (DOD) laboratories, and select international laboratories. The test kits are bolstering global laboratory capacity for detecting SARS-CoV-2. (Photo and caption copyright: Centers for Disease Control and Prevention.)

Serologic Test Under Development

The current test has to be performed after a patient shows symptoms. The “outer bound” of the virus’ incubation period is 14 days, meaning “we expect someone who is infected to have symptoms some time during those 14 days,” Messonnier said. Testing too early could “produce a negative result,” she continued, because “the virus hasn’t established itself sufficiently in the system to be detected.”

Messonnier added that the agency plans to develop a serologic test that will identify people who were exposed to the virus and developed an immune response without getting sick. This will help determine how widespread it is and whether people are “seroconverting,” she said. To formulate this test, “we need to wait to draw specimens from US patients over a period of time. Once they have all of the appropriate specimens collected, I understand that it’s a matter of several weeks” before the serologic test will be ready, she concluded.

“Based on what we know now, we believe this virus spreads mainly from person to person among close contacts, which is defined [as] about six feet,” Messonnier said at the follow-up telebriefing. Transmission is primarily “through respiratory droplets produced when an infected person coughs or sneezes. People are thought to be the most contagious when they’re most symptomatic. That’s when they’re the sickest.” However, “some spread may happen before people show symptoms,” she said.

The virus can also spread when people touch contaminated surfaces and then touch their eyes, nose, or mouth. But it “does not last long on surfaces,” she said.

Where the Infection Began

SARS-CoV-2 was first identified during an outbreak in Wuhan, China, in December 2019. Soon thereafter, hospitals in the region “were overwhelmed” with cases of pneumonia, Dr. Acharya explained, but authorities could not trace the disease to a known pathogen. “Every time a new pathogen originates, or a current pathogen mutates into a new form, there are no molecular tests available to diagnose it,” he said.

So, genetic laboratories used next-generation sequencing, specifically unbiased nontargeted metagenomic RNA sequencing (UMERS), followed by phylogenetic analysis of nucleic acids derived from the hosts. “This approach does not require a prior knowledge of the expected pathogen,” Dr. Acharya explained. Instead, by understanding the virus’ genetic makeup, pathology laboratories could see how closely it was related to other known pathogens. They were able to identify it as a Betacoronavirus (Beta-CoVs), the family that also includes the viruses that cause SARS and Middle East Respiratory Syndrome (MERS).

This is a fast-moving story and medical laboratory leaders are advised to monitor the CDC website for continuing updates, as well as a website set up by WHO to provide technical guidance for labs.

—Stephen Beale

Related Information:

CDC Tests for COVID-19

CDC: Information for Laboratories

About Coronavirus Disease 2019 (COVID-19)

Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus

Coronavirus Disease (COVID-19) Outbreak

Coronavirus Disease (COVID-19) Technical Guidance: Laboratory Testing for 2019-nCoV in Humans

Novel Coronavirus Lab Protocols and Responses: Next Steps

WHO: China Leaders Discuss Next Steps in Battle Against Coronavirus Outbreak

Transcript for CDC Telebriefing: CDC Update on Novel Coronavirus February 12

Transcript for CDC Media Telebriefing: Update on COVID-19 February 14

Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins

Nominations Now Open for 5th Annual National Clinical Laboratory Sales Excellence Awards

This is an opportunity for top-producing sales reps from medical laboratories, anatomic pathology groups, and lab vendors to achieve national recognition at the upcoming Executive War College

Nominations are now open for The Dark Report’s 5th Annual National Lab Sales Excellence Awards. This awards program recognizes those laboratory sales professionals who exceed sales goals and successfully help their lab organization win new clients and expand market share.

Nominating applications are available at Executive War College/5th Annual National Lab Sales Excellence Awards and should be submitted by the sales professional’s sales manager based on the sales rep’s 2019 performance. Winners will receive an all-expense paid trip to New Orleans for the 25th Annual Executive War College on Lab and Pathology Management on April 28-29.

Each winner will also receive a check for $2,000!

“This is the fifth year for this first and only national recognition program in the United States for sales professionals involved in the clinical laboratory profession,” stated Robert L. Michel, Editor-in-Chief of The Dark Report. “It’s important for our industry because it shows the leaders and pathologists in other labs that, despite negative trends in the lab marketplace, there are sales professionals who continue to generate substantial volumes of new clients, new specimens, and new revenue for the clinical labs and pathology groups they represent.

“Moreover, as the sales team in your lab learns what some of their top-performing peers have accomplished, it raises the bar and motivates them to achieve more and reach for stretch goals that benefit them personally and contribute to the success of the lab that they represent,” emphasized Michel.

“Each year, the winners of the National Lab Sales Excellence Award tell us that this recognition was not only important for them, but that their hospital CEO and senior administrators took notice and it raised the profile of the lab throughout the entire hospital because of the national recognition for the accomplishments of the lab’s top sales producer. In some cases, the local newspapers picked up the story and reported it—another positive benefit for the lab in the community. Some award winners report that just the news coverage of the award led to new accounts from physicians who wanted the top service these lab sales professionals deliver.”

Winners are selected in each of three categories that represent the major sectors of the lab testing marketplace. The sectors are:

  • Hospital Laboratory Outreach;
  • Independent Clinical/Anatomic Pathology Laboratory (including molecular and genetic testing); and
  • Laboratory Supply Company/In Vitro Diagnostics Equipment Company.
Robert L. Michel, Editor-in-Chief of The Dark Report, is shown above with Tammy W. Mullen, Sales Representative with HealthLab in Aurora, Ill., a full-service, pathologist-directed clinical laboratory that is part of Northwestern Medicine. Mullen received her award during the 2019 Executive War College on Laboratory and Pathology Management in New Orleans. Each year, Laboratory Sales professionals are recognized for their achievements with the National Lab Sales Excellence Award. (Photo copyright: The Dark Report.)

Nominations for National Lab Sales Excellence Awards

“We are asking that the sales managers and sales VPs of these sales reps nominate their top candidates. Nominations of these high-achieving medical lab industry sales professionals for the National Lab Sales Excellence Award are being accepted now. Details and the nominating form are available by clicking here or by copy and pasting this URL into your web browser: https://www.executivewarcollege.com/lab-sales-excellence-award-contest/.

To be considered, nominee applications should encompass actual sales results, feedback from nominating managers, and references from clients. Lab sales professionals will also be judged on other variables, such as:

  • The competitive environment;
  • Compliance with all state and federal regulations; and
  • Ethical behavior.

“A panel of judges will evaluate each nomination,” noted Michel. “These are individuals with their own impressive track record in sales and marketing. They understand the techniques of ethical selling, the unique aspects of marketing laboratory tests, and how much effort is required to build the number of clients, specimen volume, and revenue from assigned territories.”

It’s the medical laboratory industry’s first and only National Laboratory Sales Award program. Sales representatives employed by clinical laboratories, anatomic pathology groups, specialty molecular and genetic testing lab companies, in vitro diagnostics companies, and laboratory information technology companies will be competing for national recognition as The Dark Report announces the winners of its 5th annual National Lab Sales Excellence Awards during the Executive War College on Laboratory and Pathology Management, which takes place April 28-29, 2020, in New Orleans. (Image copyright: The Dark Report.)

2020 Lab Sales Awards to Be Announced on April 29 in New Orleans

Nominations for the National Lab Sales Achievement Award are to be submitted to the offices of The Dark Report by Friday, March 20, 2020. Winners in each of the three categories will be notified by April 3 to allow them time to make arrangements to travel to New Orleans to be at the Executive War College for the award ceremony.

“Lab CEOs and hospital/health network lab administrators should recognize how having a winner from their sales team can turbo-charge their entire clinical laboratory sales program,” observed Michel. “By their nature, the 20% of the sales reps in your marketing program who do 80% of the business are highly competitive. We’ve had the sales vice presidents who nominated their top sales producer tell us, a year later, that having a National Lab Sales Excellence Award winner motivated the entire sales team, and that their lab saw substantial increases in specimen volume and revenue because other sales reps wanted to step up to the plate and show what they could produce.”

Michel also took the time to address the long-standing popular wisdom in the clinical laboratory industry that every lab wants to keep its top sales producers under wraps, because if competitors knew how much new lab business they were generating, competitors would recruit them away.

“This is one of those clinical lab industry widely-held beliefs that needs to disappear,” he explained. “The reality is that, in every community, competing labs (and competing sales reps) always know who the top producers are. Good lab leaders know how to retain their top performers and one way to do that is to boost their reputations and recognize their sales achievements by nominating these high-energy, result-driven producers for the unique recognition that comes from the National Lab Sales Excellence Award.”

Lab CEOs, administrators, Sales VPs, and Sales Managers—you can click here to get the nominating form for the 5th Annual National Lab Sales Excellence Awards (or by pasting this URL into your browser: http://www.executivewarcollege.com/wp-content/uploads/National-Lab-Sales-2020-Nomination-Form_02-13-2020.pdf).

—Michael McBride

Related Information:

To learn about The Dark Report’s National Lab Sales Excellence Award program

To access the nomination form for the National Lab Sales Excellence Award

Why Clinical Labs and Anatomic Pathology Are at Risk Because of No Formal Succession Plan to Develop Their Next Generation of Management Leaders

Speakers from UCLA, Alverno Clinical Laboratories, and TriCore Reference Labs Discuss the Creation of Value-Added Lab Services at 20th Annual Executive War College

;