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

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Clinical Laboratories and Pathology Groups

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Covenant Medical Center Creates Pilot Program to Help Alleviate its Nursing Shortage

New care model uses a ‘virtual nurse’ to interact with the patient in ways appropriate to the level of care

Clinical laboratories and pathology groups aren’t the only healthcare organizations currently experiencing critical industrywide shortages. A chronic nursing shortage is prompting hospitals like Covenant Medical Center in Lubbock, Texas, to invent unique ways to circumvent this issue while still managing to provide exemplary patient care.

Covenant, an affiliate of Providence—a 51 hospital/1,000 clinic healthcare network spanning Alaska, California, Montana, New Mexico, Oregon, Texas and Washington—piloted a hybrid nursing model called “Co-Caring.”

The model “uses virtual nursing to care for patients and support the bedside team through two-way audio and video telehealth technology,” according to a Providence news release. This allows nurses to focus on more vital roles, such as administering medication and assessing patients’ conditions, while day-to-day tasks are performed by assistants and virtual nurses.

After operating successfully for one year at a 30-bed unit within the 381-bed Covenant, the Co-Caring model was expanded to 10 other units in hospitals operated by Providence where it reduced the workload for bedside nurses, increased caregiver collaboration, and resulting in financial benefits for the facility.

“This pilot is not about one unit in one hospital,” Julie Wright, RN (above), who at the time was a Nurse Manager at Covenant, in a Providence news release. “It is about taking the first steps to changing how we care for our patients. We are working on creating an environment where burnout is the exception and not the rule, and where joy is the expectation.” Clinical laboratories might use a similar approach to enable pathologists and clinical laboratory scientists to dedicate their time to higher-value tasks. (Photo copyright: LinkedIn.)

Elevating the Practice of Nurses

“The past three years dramatically transformed our industry and workforce in ways that accelerated the modernization of care,” said Providence SVP and System Chief Nursing Officer Sylvain Trepanier, RN, in the news release. “Co-Caring represents an innovative solution to one of healthcare’s most pressing issues—the increased need for nurses, which for the United States is currently estimated at more than 200,000 new nurses required each year to account for population growth.”

The roots of the Co-Caring model were created by nurses for nurses. Under the Co-Caring initiative, a support team of certified nursing assistants (CNAs), patient care technicians (PCTs) and nurse technicians (NTs) perform routine functions, reducing demand on nurses.

“By creating a new team that would share responsibility and accountability with a nurse that would be working virtually, we have people showing up every day doing the work that they love to do and removing some of the barriers that they had in doing it the old traditional way,” Trepanier told the Catholic Health Association of the United States (CHAUSA).

“Quite frankly, when we embraced this, even if we could cover our costs and it would be cost neutral, it would be a great proposition,” he continued. “The pleasant surprise of this is that we’re elevating the practice of nurses, the technicians feel a part of the team, and the patients are having a good experience. We’re having great operational outcomes and decreasing the total cost of care.”

Virtual Nurses

Virtual nurses are utilized through a bi-directional audio/video telehealth platform to support the bedside team in caring for patients. These virtual nurses assist with tasks like admission processes, discharge preparation, pre-procedural checklists, and medication reconciliation. Interdisciplinary Team Meetings, which include the virtual nurses alongside charge nurses, physicians, and case managers, are held daily to ensure the best patient care.  

The Co-Caring model increased patient and caregiver satisfaction while simultaneously having positive financial significance. The first-year turnover rate (FYTO) among registered nurses decreased by 73% and by 55% for all staff involved in the program. Covenant was also able to decrease the amount of travel nurses it needed, which enabled it to hire more nurses, CNAs, and PCTs.

“On a 30-bed unit, we ended up having a return on our investment of roughly $450,000,” Trepanier told CHAUSA. “Our patients are happier, our nurses are happier, and we’re decreasing our total cost of care, which is what everyone should be after.

“If we don’t do this, we are going to run out of time in healthcare,” he continued. “I recognize that not everyone has the resources and not everyone has the capability of pulling something off like that. I also am very cognizant that the status quo is not an option. For the sake of our patients and for the sake of the health of the communities that we serve, we all need to lean in and figure out how to approach the work differently.”

Lessons for Clinical Laboratories

This innovative approach identifies which tasks need to be performed by skilled individuals and which can be done by lesser qualified personnel. Tasks are then assigned accordingly. Clinical laboratories may be able to take advantage of similar types of opportunities.

By reorganizing workflows, pathologists and clinical laboratory scientists could devote their time to higher value tasks, while the lesser tasks could be performed by pathology assistants. At a time when the number of laboratory professionals appears to be decreasing, it is imperative that lab managers develop ways to operate labs more efficiently.               

—JP Schlingman

Related Information:

Covenant Medical Center, a Providence Affiliate, Revolutionizes the Way Nurses Deliver Care

Co-Caring Uses Virtual Nurses to Help Caregivers and Patients

Hybrid Nursing Model Expands Following Successful Pilot

Providence to Expand Co-Caring Model That Adds Virtual Nurses to the Team

Federal Centers for Disease Control and Prevention Advises Hospital Medical Laboratories to Increase Bird Flu Testing

HHS urges clinical laboratories and public health labs to prepare for an increase in avian influenza A test orders during this year’s flu season

On January 16, the federal Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory urging physicians and clinical laboratories to adhere to a shortened timeline for performing analysis and subtyping on all influenza A (H1N1) specimens during the current flu season. This is due to a marked increase in avian influenza A (H5N1, aka, bird flu) infections among humans.

The CDC suggests that hospitals treating patients for flu symptoms perform clinical laboratory tests for avian influenza A within 24 hours. This additional testing will pinpoint the specific type of flu infecting an individual patient and help prevent further spread of the bird flu virus.

“It’s the subtyping that takes us from knowing that a virus is in the general bucket of ‘influenza A’ to knowing more specifically whether it’s a garden-variety seasonal version of influenza A or, more rarely, a novel version of influenza A like H5N1,” CDC Principal Deputy Director Nirav Shah, MD, JD, told CNN.

According to the CDC, a panzootic of pathogenic avian H5N1 flu virus is currently affecting wild birds, poultry, dairy cows, and other animals throughout the country. There have been 67 total cases of bird flu identified in humans in the US since 2022, with 66 of those cases occurring in 2024.

The risk of humans contracting bird flu are low but is elevated among those who work closely with wild birds, poultry, and dairy cattle. The incidences of the flu virus in animals continues to increase, so CDC says it is important to identify potential bird flu cases in humans in a timely manner.

This demonstrates recognition by the CDC and the clinical laboratory profession that advances in molecular diagnostics and genetic testing now make it feasible for many hospital labs to perform these tests in-house on relevant patients. Such molecular testing is less expensive and produces a faster answer today, compared to just a few years ago.

This call for more lab tests in hospitals is also recognition of the value near-patient testing has from a public health perspective. Historically, it was regional and local public health labs that were sent specimens for testing from patients identified as having an infection that were a public health concern.

The good news is that this expands the role of hospital laboratories for all the right reasons. The downside is that hospital labs will probably see many test claims for these assays not be paid promptly by payers—or paid after unnecessary delays.

“The system right now tells us what has already happened. What we need is to shift to a system that tells us what’s happening in the moment. That is what we are doing today,” Nirav Shah, MD, JD (above), CDC principal deputy told CNN. Hospital and clinical laboratories will likely see an increase in orders for molecular and genetic testing for influenza A. (Photo copyright: Centers for Disease Control and Prevention.)

CDC Recommendations to Clinical Laboratories

The CDC alert also acknowledges that most individuals infected with avian flu were exposed to the virus via the handling of infected dairy cows or poultry in unprotected workplaces. There are no known cases of human-to-human transmission of the disease.

Most cases of avian flu in humans have been clinically mild and the patients quickly recover. However, on January 6, the CDC announced that an elderly patient with underlying health conditions in Louisiana who was previously hospitalized with severe avian influenza A illness had passed away. This case was the first confirmed death in the US attributed to the illness.

The CDC’s Health Advisory makes the following recommendations to clinical laboratories:

  • Subtype respiratory specimens that are positive for influenza A, but negative for seasonal influenza A virus subtypes, and forward those specimens to a public health laboratory within 24 hours.
  • Refrain from batching specimens for consolidated or bulk shipment to public health laboratories if that process could result in shipping delays.
  • Notify public health officials if a hospital or clinical lab does not have access to influenza A virus subtyping and arrange for a public health or commercial lab with this testing capability to perform the analysis.
  • Clearly link specimens to clinical information from the patient to ensure the prioritization of severely ill and ICU patients.
  • Immediately contact local public health authority if a positive result for influenza A (H5) virus is obtained using a laboratory developed test (LDT) or another A (H5) subtyping test to initiate time-critical actions.

The CDC’s Health Advisory also states public health laboratories should complete influenza A subtyping assays within 24 hours of receipt and report those results to the CDC, as required.

“One of the motivators of accelerating testing [is] so that we are, again, able to faster see difference between signal and noise, given that the volume of hospitalizations is going up as expected in a rather routine flu season,” Demetre Daskalakis, MD, MPH, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), told CNN

Preparing for more Bird Flu in Humans

According to the CDC, approximately 100,000 Americans have been hospitalized with type-A flu this season. The agency expects another 100,000 hospitalizations due to the virus before the end of this year. CDC is tracking flu infections on a weekly basis. Data can be reviewed on its website.

Other government organizations also are developing methods intended to curb the spread of the influenza virus. The federal Department of Agriculture recently launched a national program to test for bird flu in untreated milk. And the US Department of Health and Human Services (HHS) allocated $211 million in new funding to address emerging infectious diseases.

On January 17, the HHS announced it would give $590 million to Moderna to “accelerate the development of mRNA-based pandemic influenza vaccines and enhance mRNA platform capabilities so that the US is better prepared to respond to other emerging infectious diseases.”

“The funding will allow us to bring the benefits of mRNA vaccine technology to bear against a wider array of emerging threats,” said HHS Assistant Secretary for Preparedness and Response Dawn O’Connell, JD, in the announcement. “mRNA technology can be faster to develop and easier to update than other vaccines making it a helpful tool to have against viruses that move fast and mutate quickly.

Hospital laboratories and public health labs should prepare for a spike in test orders for avian influenza A as this year’s flu season progresses. As bird flu increases in animals, it increases the possibility that the disease might infect humans.  

—JP Schlingman

Related Information:

Accelerated Subtyping of Influenza A in Hospitalized Patients

CDC Urges Doctors to Speed Subtyping of Patients Hospitalized with the Flu to Better Track H5N1 Infections

CDC Urges Faster Testing to Find Human Bird Flu Cases

Weekly US Influenza Surveillance Report: Key Updates for Week 2, Ending January 11, 2025

HHS Intends to Provide $211 Million to Accelerate, Enhance Platform Capability for Emerging Infectious Diseases

CDC Urges Hospitals to Fast-track Bird Flu Testing

First H5 Bird Flu Death Reported in United States

Top CDC Officials Warns US Needs ‘More Tests’ in Face of Bird Flu Fears

HHS Provides $590 Million to Accelerate Pandemic Influenza mRNA-based Vaccine Development, Enhance Platform Capability for Other Emerging Infectious Disease

Genetic Tests Are Detecting Prevalence of Bird Flu Virus in US Wastewater and Allowing Officials to Track its Spread

CDC Enlists Five Commercial Medical Laboratories to Bolster Avian Flu Testing Capacity in the United States

Federal Judge Dismisses Antitrust Lawsuit Brought by Four Pathologists against Iowa Pathology Practice

Judge decides injuries claimed by pathologists are not antitrust injuries and that plaintiffs have no standing to bring antitrust lawsuit

Four pathologists who filed an antitrust lawsuit alleging their former employer “engaged in a series of unfair and deceptive practices” in an effort to maintain a monopoly on clinical pathology services in central Iowa had their lawsuit dismissed by a federal judge. The plaintiffs appealed the decision. Two related state lawsuits are still pending, one in which the plaintiffs are the defendants.

The four pathologists—Tiffani Milless MD, Caitlin Halverson MD, Renee Ellerbroek MD, and Jared Abbott MD—were employed by Iowa Pathology Associates PC (IPA) and an affiliated company, Regional Laboratory Consultants PC (RLC), both based in Des Moines.

It is common for pathologists in a community to leave one pathology practice and either establish a new practice or join a nearby practice. What is less common is litigation that involves the original group practice and the departed pathologists.

Thus, this example of lawsuits and counter lawsuits is interesting because it creates court rulings about the strengths and weaknesses of the arguments asserted by both plaintiffs and defendants in situations where pathologists leave their employer but continue to practice in the same community.

The court decisions in these cases demonstrate how judges are handling these issues involving antitrust allegations, market share, and non-compete agreements.

“As a result of Defendants’ alleged conduct, Goldfinch asserts its ability to compete has been severely undermined and ‘has the potential to harm patients,’” wrote federal judge Rebecca Goodgame Ebinger, JD (above), in her order granting defendants’ motion to dismiss. “These injuries are not antitrust injuries because they do not stem from conduct affecting competition in the pathology and dermatopathology markets generally.” Clinical laboratories and anatomic pathology practices can learn from the decisions handed down in this court case. (Photo copyright: Wikipedia.)

Pathologists Accuse Defendants of Suppressing Competition

In their original complaint, which was filed May 13, 2024, in the US District Court for the Southern District of Iowa, the plaintiffs said that, beginning in 2021, IPA “strongly pressured” them to sign an employment agreement that would have prevented them from launching a competing practice in the Des Moines area. They refused to comply, but “the administrator of these corporations told these pathologists that the Agreement was in effect even though they had not signed it,” the complaint states.

On October 2022, they informed IPA that they intended to leave to form their own pathology practice, according to the complaint.

The new practice, Goldfinch Laboratory in Urbandale, Iowa, began offering pathology services in February 2023.

“Prior to the formation of Goldfinch, IPA was the only independent pathology practice in central Iowa that was not exclusively tied to one source of referrals,” the complaint states. In addition, “it was the only independent pathology practice in central Iowa that offered dermatopathology services.”

After they notified IPA and RLC of their intention to leave, the plaintiffs alleged that the employer engaged in a series of efforts to “suppress competition” and monopolize the local market for pathology and dermatopathology services.

Plaintiffs Allege Defendants’ Behavior Could Have Harmed Patients

The pathologists were barred from entering IPA’s offices, leaving potential referring physicians with the impression that “these pathologists were no longer practicing,” the complaint states, and preventing them from “maintaining on-going relations with potential referral sources.”

IPA, the complaint alleges, “refused to share biopsy slides with Goldfinch pathologists when those slides were required for continuity of care of the patient—even though this practice was contrary to the standard of care and could well have caused harm to patients.” The complaint characterized this as “an effort to induce referral sources not to make referrals to Goldfinch.”

The plaintiffs also alleged that IPA and RLC made “false and deceptive statements to dissuade referral sources from making referrals to Goldfinch,” for example by claiming that legal problems would force the practice to close.

Given their “monopoly power” in the local market, the plaintiffs argued, IPA and RLC “were able to charge supracompetitive prices for their services.” A $1.4 million contract with one hospital corporation was “in the top 5% of Part A contracts in the United States,” the complaint alleges, and rural hospitals paid “at least 400% of the actual Medicare fee schedule amount for the technical component of pathology services for Medicare patients.”

Defendants’ Response to Allegations

In their motion to dismiss the suit, the defendants argued that Goldfinch was “a classic ‘disgruntled competitor’” that had not demonstrated an “antitrust injury” as defined by federal and state law.

“Goldfinch’s owners used to work for IPA and RLC, voluntarily left, and now seek to litigate their personal financial losses under the guise of federal and state antitrust claims,” the motion states.

The defendants also argued that Goldfinch lacked standing to file an antitrust claim.

Goldfinch “alleges the ‘antitrust practices’ of IPA and RLC are harmful to patients and other payers for pathology and dermatopathology services,” the motion states. “But patients and payers are quite capable of noticing and seeking redress for the alleged harms and Goldfinch need not do so on their behalf.”

In addition, the defendants argued, Goldfinch failed to adequately define a “plausible” product market or geographic market that was subject to the alleged monopoly power.

“Goldfinch’s alleged geographic market is vaguely ill-defined as ‘central Iowa,’” the motion states. “But there is a difference between the service area and a geographic market.” The motion cited an earlier decision in which the US Court of Appeals for the Seventh Circuit “deemed a relevant market for a pathology practice to be nationwide.”

Judge’s Decision

Federal judge Rebecca Goodgame Ebinger, JD, sided with the defendants in a decision handed down on Dec. 13.

“As a result of Defendants’ alleged conduct, Goldfinch asserts its ability to compete has been severely undermined and ‘has the potential to harm patients,’” she wrote. “These injuries are not antitrust injuries because they do not stem from conduct affecting competition in the pathology and dermatopathology markets generally. These injuries, instead, are a result of Defendants’ alleged actions targeting Goldfinch and demonstrate an injury to Goldfinch as a competitor—the loss of some patients and referral sources.”

She also agreed with the defendants that Goldfinch lacked sufficient standing to bring an antitrust claim, and that the plaintiffs had failed “to adequately allege a relevant market for pathology and dermatopathology services.”

Goldfinch filed a Notice of Appeal on Jan. 10.

State Lawsuits Pending

Meanwhile, both parties are awaiting a decision in a state court lawsuit in which the Goldfinch partners are the defendants, according to the Iowa Capital Dispatch.

IPA filed the suit late in 2022, shortly after learning that the four pathologists planned to leave and start their own practice. It alleged “breach of contract, breach of the common law duty of loyalty, civil conspiracy and tortious interference,” Iowa Capital Dispatch reported at the time, claiming that the pathologists were improperly attempting to lure clients away.

In a related case, Goldfinch pathologists Milless and Halverson have filed a state discrimination lawsuit against their former employer, “alleging they were paid $200,000 to $350,000 annually, which they claim was far less than what some of the less qualified male doctors were paid,” Iowa Capital Dispatch reported. That case goes to trial in August.  

This is a plethora of lawsuits involving pathologists and the pathology practices in the communities where they formally practiced. Pathologists and group pathology managers may find useful insights from a study of the legal arguments made by the two parties, as well as the decisions laid down by judges in these court cases.               

—Stephen Beale

Related Information:

Lawsuit Claiming Pathology ‘Monopoly’ Is Dismissed by Court

Legal Battle Escalates over Pathologists’ ‘Monopoly’ and Its Impact on Patients

Des Moines Pathologists Sue Their Partners in a Battle over Market Share

Tracking 20 Years of Rising Health Insurance Costs and Their Impact on Patients and Employees

Clinical laboratories are being squeezed on both sides as rising healthcare costs affect their patients while increasing health plan costs impact their employees’ health coverage

When UnitedHealthcare CEO Brian Thompson was murdered on Dec. 4, the nation’s attention focused on the negative impact ever-increasing costs of healthcare coverage is having on the average American. Clinical laboratories and anatomic pathology groups experience this trend firsthand as annual increases in the cost of health plans affect their employees.

To understand just how raw the public is feeling about health insurance, consider that in a recent Emerson College poll, 41% of respondents ages 18-29 stated that Thompson’s murder was “completely” or “somewhat” acceptable.

While the majority of the country believes that such violence is not an acceptable way to solve one’s problems, the message is clear that Americans’ waning trust in health insurance companies has reached unhealthy levels.

“Health insurance costs are far outpacing inflation, leaving more consumers on the hook each year for thousands of dollars in out-of-pocket expenses. At the same time, some insurers are rejecting nearly one in five claims. That double whammy is leaving Americans paying more for coverage yet sometimes feeling like they’re getting less in return,” CBS News reported.

Twenty-five years of increases from the insurance industry make it clear why the relationships between healthcare consumers and insurance companies has soured.

“Employers are shelling out the equivalent of buying an economy car for every worker every year to pay for family coverage,” said Kaiser Family Foundation President and CEO Drew Altman (above) in a news release. “In the tight labor market in recent years, they have not been able to continue offloading costs onto workers who are already struggling with healthcare bills.” Clinical laboratories and pathology groups are among those employers struggling to provide affordable health coverage for their employees. (Photo copyright. Kaiser Family Foundation.)

People Are Frustrated

The cost of living in America has risen dramatically in the past decade. So much so that people are increasingly becoming frustrated and lashing out against companies that appear to be making record profits while their customers struggle to pay for their products and services.

A recent Kaiser Family Foundation (KFF) Health Tracking Poll found that “About one in five adults (19%) say they have difficulty affording their bills each month and about four in 10 (37%) say they are just able to afford their bills each month, while a little over four in 10 (44%) say they are both able to pay their bills and have some money left over.”

Simultaneously, according to KFF, “Employees’ share of their [health insurance] premiums are also on the rise, with a worker with family coverage typically paying premiums of $5,700 per year in 2017, the most recent year for that data, up from about $1,600 in 2000. … The average family deductible—the amount paid out-of-pocket before insurance kicks in—has increased from $2,500 in 2013 to $3,700 in 2023.”

This double-whammy in costs has a growing number of American’s worrying about unexpected healthcare bills and the overall cost of keeping their families adequately covered for the future.

“We’ve gotten to a point where healthcare is so inaccessible and unaffordable, people are justified in their frustrations,” said Céline Gounder, MD, a CBS News medical contributor and editor-at-large for public health at KFF Health News.

The chart above taken from a KFF Health Tracking Poll (Jan. 30-Feb. 7, 2024) shows participants’ answers when asked, “How worried, if at all, are you about being able to afford each of the following for you and your family?” Results indicate, according to KFF, that three in four people polled are worried about paying future healthcare bills and covering increasing insurance costs. (Graphic copyright: KFF.)

AI and Coverage Denials

Coverage denials is another sore spot for many people, impacting nearly one in five claims in nongroup qualified health plans in 2021, KFF found. This ranged from 2% to 49% depending on the company.

“When you are paying for something, they don’t give it to you, and they keep raising prices … you will be frustrated by that,” Holden Karau, a software engineer and creator of Fight Health Insurance, a free online service that helps people appeal their denials, told CBS News. Karau’s company uses artificial intelligence (AI) to help customers create appeal letters.

But the use of AI in healthcare coverage has also drawn criticism. Insurance companies are increasingly using AI to review claims and issue denials, and the lack of transparency has led to lawsuits. Last year, CBS News covered lawsuits brought by the families of two deceased individuals who accused UnitedHealthcare of “knowingly” using a “faulty” AI algorithm to deny the patients medically necessary treatments.

Karau noted, “With AI tools on the insurance side, they have very little negative consequences for denying procedures,” CBS News reported. “We are seeing really high denial rates triggered by AI. And on the patient and provider side, they don’t have the tools to fight back,” she added.

“Unhappiness with insurers stems from two things: ‘I’m sick and I’m getting hassled,’ and the second is very much cost—‘I’m paying more than I used to, and I’m paying more than my wages went up,’” Rob Andrews, CEO of Health Transformation Alliance, a company that helps healthcare providers and other self-insured companies improve coverage for their employees, told CBS News. “A lot of people think they are getting less,” he added.

Effects on Clinical Laboratories

Even as individuals and families pay more money each year in healthcare premiums, deductibles, and out-of-pocket expenses, clinical laboratories have seen payers cut reimbursement for many lab tests. Thus, labs are dealing with a double-squeeze on their finances. On the income side, reimbursement for tests is under pressure, while on the cost side, the cost of health benefits for employees climbs annually.

Clinical lab and pathology managers will want to stay aware of these trends and take advantage of any opportunity to lower costs and pass on those savings to their patients.

—Kristin Althea O’Connor

Related Information:

As Anger at UnitedHealthcare Boils Over, Americans Pay More than Ever for Health Insurance

December 2024 National Poll: Young Voters Diverge from Majority on Crypto, TikTok, and CEO Assassination

Why Americans Are Outraged Over Health Insurance—and What Could Change

International Researchers Draft Consensus Document That Establishes Framework for Microbiome Testing

Microbiologists and clinical laboratory professionals should play a key role in the ordering and use of microbiome testing

International experts in the field of microbiome testing recently published a consensus document that establishes guidelines for the use and distribution of microbiota diagnostics they claim are long overdue. Companies offering direct-to-consumer (DTC) microbiome test kits continue to increase in number and popularity. But some experts in the human microbiome field—including microbiologists and clinical laboratory professionals—remain apprehensive regarding the science behind this type of home testing.

In their paper, the team, led by microbiota researchers Antonio Gasbarrini, MD, Giovanni Cammarota, MD, and Gianluca Ianiro, MD, professors at the Agostino Gemelli University Polyclinic Foundation IRCCS and Catholic University of the Sacred Heart, wrote, “We aimed to establish a framework to regulate the provision of microbiome testing and minimize the use of inappropriate tests and pave the way for the evidence-based development and use of human microbiome diagnostics in clinical medicine.”

A Gemelli University news release states, “The intestinal microbiota could perhaps one day become a routine tool for the early diagnosis of many diseases and treatment guidance, but at the moment there is a lack of solid scientific evidence to support these indications. Yet, day by day, the offers of commercial kits are multiplying to carry out do-it-yourself tests, at the moment completely devoid of scientific significance and solidity.”

It continues, “To put a stop to this drift, a panel of international experts, coordinated by Dr. Gianluca Ianiro, has drafted the ‘instructions for use’ for best practices related to microbiota testing and recommendations for its indications, analysis methods, presentation of results and potential clinical applications.”

The experts published their paper, “International Consensus Statement on Microbiome Testing in Clinical Practice,” in the journal Lancet Gastroenterology and Hepatology.

“This document marks a decisive step towards a standardization that has become indispensable making the microbiota an increasingly integrated element in personalized medicine,” said gastroenterologist Antonio Gasbarrini, MD (above), dean of the faculty of medicine and surgery and full professor of internal medicine at Catholic University of the Sacred Heart. “In the clinical context, these guidelines will be essential to translate research progress into concrete applications, improving the management of many gastroenterological and systemic diseases related to the microbiota,” he added. Microbiologists and clinical laboratory managers may want to follow efforts to promote these guidelines, both within healthcare and as they relate to consumers ordering their own microbiome tests. (Photo copyright: Agostino Gemelli University.)

Our Second Brain

The gut microbiome consists of the microorganisms that reside in the human gut and the small and large intestines. This ecosystem plays a major role in an individual’s health as it aids in digestion and metabolism. It also helps control inflammation and can strengthen the immune system.

“[The gut microbiome] contains all the microbes that reside within our intestinal tract. And those microbes are comprised of bacteria, fungi, yeast and viruses,” said Gail Cresci, PhD, RD, Director, Nutrition Research Center for Human Nutrition at the Cleveland Clinic in a Health Essentials article.

“What we’ve learned over the years is that there’s a lot of crosstalk between your gut microbiome and your body,” she added. 

A healthy gut microbiome is imperative for good human health. An unhealthy gut microbiome can lead to certain diseases and even have a negative effect on mental health and mood.

“Your gut health is so important because studies really do indicate that our gut health plays a huge role in our overall health,” stated Kristin Kirkpatrick, MS, RDN, a dietician at the Cleveland Clinic Department of Wellness and Preventative Medicine, in the article. “It impacts our risk of chronic conditions, our ability to manage our weight, even our immune system. … There is so much attention and research on the microbiome and gut health now that experts often refer to it as the ‘second brain.’”

Future of Microbiome Testing

In their consensus document, the scientists wrote, “We convened an international multidisciplinary expert panel to standardize best practices of microbiome testing for clinical implementation, including recommendations on general principles and minimum requirements for their provision, indications, pre-testing protocols, method of analyses, reporting of results, and potential clinical value. We also evaluated current knowledge gaps and future directions in this field.”

The team’s intent is to provide guidelines and define quality standards and accuracy for microbiome testing to ensure consumers are receiving factual information.

“In recent years, the intestinal microbiota has taken on a key role as a diagnostic, prognostic and therapeutic tool,” said gastroenterology surgeon Serena Porcari, MD, of Gemelli University Hospital in Italy, in the Gemelli news release. “From this point of view, the first step, for a targeted modulation of the microbiota itself, is to obtain a standardization of its analysis, regulated according to the definition of minimum criteria for performing the test.”

The team also evaluated disparities between various tests and anticipated what lies ahead for the future of microbiome testing. In addition, they assessed ways to minimize inappropriate testing and established a framework for the development of evidence-based testing and the use of human microbiota diagnostics in clinical medicine.

“This consensus document represents a crucial step towards bringing order to the current panorama of diagnostic tests on the intestinal microbiota,” said Maurizio Sanguinetti, MD, director of the department of laboratory and hematological sciences at Gemelli Polyclinic Foundation, in the news release. “The diagnostic characterization of the intestinal microbiota must be based on rigorous standards, in order to guarantee reliable and clinically useful results. It is not a simple laboratory test, but a complex tool that requires a deep understanding of microbial dynamics and their impact on human health.

“This is why these analyses must be conducted by highly qualified personnel with specific expertise in clinical microbiology and bioinformatics,” he emphasized. “In our microbiology laboratory at the Fondazione Policlinico Gemelli, we already apply diagnostic tests on the intestinal microbiota following the principles and best practices outlined in the document.

“It is essential to invest in the training of future physicians and microbiologists so that they acquire the necessary skills to correctly interpret the results of these tests and apply them effectively in clinical practice. This document provides a valuable basis to guide not only the current use of the tests, but also their future development, always with a view to evidence-based and personalized medicine,” Sanguinetti concluded.

With popularity of microbiome testing on the rise, it’s important that microbiologists and clinical laboratory professionals stay informed on the latest developments in the field of microbiome diagnostics to protect healthcare consumers and their patients.

—JP Schlingman

Related Information:

International Experts Set Framework for Microbiota Diagnostics

Gut Microbiota: A Consensus Document Brings Order to Diagnostic Testing

International Consensus Statement on Microbiome Testing in Clinical Practice

How Your Gut Microbiome Impacts Your Health

Mayo Clinic Scientists Develop AI Tool That Can Determine If Gut Microbiome is Healthy

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