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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US

Some experts in medical community question value of health screenings of older patients with shortened life expectancies, though many aging adults are skeptical of calls to skip tests

What does it mean when a credible health organization makes the assertion that there is an “epidemic” of clinical laboratory testing being ordered on the nation’s elderly? Clinical laboratory leaders and anatomic pathologists know that lab tests are a critical part of screening patients.

Health screenings, particularly those for chronic diseases, such as cancer, can save lives by detecting diseases in their early stages. However, as consumers become more engaged with the quality of their care, one trend is for healthcare policymakers to point out that many medical procedures and care protocols may not bring benefit—and may, instead, bring harm.

No less an authority than Kaiser Health News (KHN) also is questioning what it calls an “epidemic” of testing in geriatric patients. Since medical laboratory tests are part of many screening programs, a rethinking of what tests are necessary in older patients would likely impact clinical laboratories and pathology groups going forward.

Treatment Overkill or Necessary Clinical Laboratory Tests?

“In patients well into their 80s, with other chronic conditions, it’s highly unlikely that they will receive any benefit from screening, and [it is] more likely that the harms will outweigh the benefits,” Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at the Yale School of Medicine, told KHN as part of an investigative series called “Treatment Overkill.”

That opinion is supported by a 2014 study published in the Journal of the American Medical Association (JAMA) Internal Medicine. The researchers concluded, “A substantial proportion of the US population with limited life expectancy received prostate, breast, cervical, and colorectal cancer screening that is unlikely to provide net benefit. These results raise concerns about over screening in these individuals, which not only increases healthcare expenditure but can lead to patient harm.”

Yet, seniors and their family members often request health screenings for themselves or their elderly parents, even those with dementia, if they perceive doing so will improve their quality of life, KHN noted.

Cary Gross, MD

Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at Yale University, told Kaiser Health News patients “well into their 80s, with other health conditions” are unlikely candidates for the many routine health screening tests administered to elderly patients. Were this to become a trend, medical laboratories could see a drop in physician-ordered screening tests. (Photo copyright: Yale University.)

Meanwhile, an earlier study in JAMA Internal Medicine found older adults perceived screening tests as “morally obligatory” and were skeptical of stopping routine screenings.

In its series, KHN noted two studies that outlined the frequency of screening tests in seniors with limited life expectancies due to dementia or other diseases:

  1. According to the American Journal of Public Health, nearly one in five women with severe cognitive impairment are still getting regular mammograms;
  2. Likewise, 55% of older men with a high risk of death over the next decade still receive PSA tests for prostate cancer, the 2014 JAMA Internal Medicine study found.

“Screening tests are often done in elderly patients as a knee-jerk reaction,” Damon Raskin, MD, a board-certified internist in Pacific Palisades, Calif., who also serves as Medical Director for two skilled nursing facilities, told AgingCare.com.

Correct Age or Correct Test?

While a movement may be afoot to reduce screening tests in older patients, a one-size-fits-all answer to who should continue to be tested may not be possible.

“You can have an 80-year-old who’s really like a 60-year-old in terms of [his or her] health,” Raskin noted. “In these instances, screening tests such as mammograms and colonoscopies, can be extremely valuable. However, I’ve seen 55-year-olds who have end-stage Parkinson’s or Alzheimer’s disease. For those individuals, I probably wouldn’t recommend screenings, for quality of life reasons.”

However, for the general population, researchers have emphasized that the focus should not be on whether physicians are ordering “unnecessary” lab tests, but whether they are ordering the “correct” tests.

A 2013 study published in the online journal PLOS ONE analyzed 1.6 million results from 46 of medicine’s 50 most commonly ordered lab tests. Researchers found, on average, the number of unnecessary tests ordered (30%) was offset by an equal number of necessary tests that went unordered.

“It’s not ordering more tests or fewer tests that we should be aiming for. It’s ordering the right tests, however few or many that is,” senior author Ramy Arnaout, MD, Harvard Medical School, Assistant Professor of Pathology and Associate Director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center in Boston, stated in a news release. “Remember, lab tests are inexpensive. Ordering one more test or one less test isn’t going to ‘bend the curve,’ even if we do it across the board. It’s everything that happens next—the downstream visits, the surgeries, the hospital stays—that matters to patients and to the economy and should matter to us.”

Since the elderly are the fastest growing population in America, and since diagnosing and treating chronic diseases is a multi-billion-dollar industry, it seems unlikely that such a trend to move away from medical laboratory health screenings for the very old will gain much traction. Still, with increasing focus on healthcare costs, the federal government may pressure doctors to do just that.

—Andrea Downing Peck

Related Information:

Cancer Screening Rates in Individuals with Different Life Expectancies

Doing More Harm Than Good? Epidemic of Screening Burdens Nation’s Older Patients

Large-Scale Analysis Describes Inappropriate Lab Testing Throughout Medicine

Preventive Screening for Seniors: Is that Test Really Necessary?

Impact of Cognitive Impairment on Screening Mammography Use in Older US Women

Cancer Screening Rates in Individuals with Different Life Expectancies

The Landscape of Inappropriate Laboratory Testing

Older Adults and Forgoing Cancer Screening: ‘Think it would be Strange’

New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories

Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools

Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools could have important implications for anatomic pathology groups and clinical laboratories.

Physician decision-support software utilizes medical laboratory test data as a significant part of a full dataset used to guide caregivers. Thus, if the FDA makes it easier for developers to get regulatory clearance for these types of products, that could positively impact medical labs’ ability to service their client physicians.

Additionally, clinical pathologists have unique training in diagnosing diseases and understanding the capabilities and limitations of medical laboratory tests in supporting how physicians diagnose disease and make treatment decisions. Thus, actions by the FDA to make it easier for developers of software algorithms that can incorporate clinical laboratory data and anatomic pathology images with the goal of improving diagnoses, decisions to treat, and monitoring of patients have the potential to bring great benefit to the nation’s medical laboratories.

FDA Clarifies Role in Regulating CDS/PDS Applications

The new guidelines clarified items specified in the 21st Century Cures Act, which was enacted by Congress in December of 2016. This Act authorized $6.3 billion in funding for the discovery, development, and delivery of advanced, state-of-the art medical cures.

“Today, we’re announcing three new guidances—two draft and one final—that address, in part, important provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement,” FDA commissioner Scott Gottlieb, MD, Commissioner of Food and Drugs, noted in a statement. “We’ve taken the instructions Congress gave us under the Cures Act and [we] are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.”

Helping Doctors’ Decision-Making

The first guideline concerns clinical decision support systems that are designed to help doctors make data-driven decisions about patient care. The new guidelines make it easier for software developers to get regulatory clearance, which, the FDA hopes, will spark innovation and makes regulation more efficient.

“CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition,” Gottlieb said in the FDA’s statement. “For example, such software can include programs that compare patient-specific signs, symptoms, or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy.

“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making,” Gottlieb continued. “We want to encourage developers to create, adapt, and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”

Identifying Digital Health Applications That Receive/Don’t Receive FDA Oversight

The second guideline discusses and delineates which digital health applications are considered low risk and, thus, will not fall under FDA regulations.

Products that are not intended to be used for the diagnosis, cure, mitigation, prevention, or treatment of a condition will not be regulated by the FDA. These technologies are not considered medical devices and may include gadgets such as weight management and mindfulness tools. They can provide value to consumers and the healthcare industry while posing a low risk to patients.

“Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk decision support software that’s intended to be used by patients or caregivers—known as patient-decision-support software (PDS)—when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation,” Gottlieb noted in the statement.

 

Scott Gottlieb

Scott Gottlieb, MD (above), FDA Commissioner of Food and Drugs, noted in a statement, “We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation. Clinical laboratories may find opportunities to work with CDS/PDS developers and support their client physicians. (Photo copyright: FDA.)

However, products that are intended to be used for the diagnosis, cure, mitigation, prevention, or treatment of a condition are considered medical devices and will fall under FDA regulations.

“The FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices, or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act,” noted Gottlieb.

Items such as mobile apps that are utilized to maintain and encourage a healthy lifestyle are not deemed to be medical devices and will fall outside FDA regulations. The guidelines also defined that Office of the National Coordinator for Health Information Technology (ONC)-certified electronic health record (EHR) systems are not medical devices and, thus, will not be regulated by the FDA.

Software-as-a-Medical Device Gets FDA Oversight

The third guidance document deals with the assessment of the safety, performance, and effectiveness of Software as a Medical Device (SaMD).

“This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight and is another important piece in our overarching policy framework for digital health,” Gottlieb noted in the statement.

SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

Gottlieb noted that the three important guidance documents being issued would continue to expand the FDA’s efforts to encourage innovation in the ever-changing field of digital health. “Our aim is to provide more clarity on, and innovative changes to, our risk-based approach to digital health products, so that innovators know where they stand relative to the FDA’s regulatory framework. Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review,” he concluded.

What remains to be seen is how the new FDA regulations will impact clinical laboratories and anatomic pathology groups. With the expanding interest in artificial intelligence (AI) and self-learning software systems, healthcare futurists are predicting a rosy future for informatics products that incorporate these technologies. Hopefully, with these new guidelines in place, innovative clinical laboratories will have the opportunity to develop new digital products for their clients.

—JP Schlingman

Related Information:

FDA Softens Stance on Clinical-decision Support Software

Clinical and Patient Decision Support Software

FDA Issues New Guidance for Clinical and Patient Decision Support Software

Statement from FDA Commissioner Scott Gottlieb, M.D., on Advancing New Digital Health Policies to Encourage Innovation, Bring Efficiency and Modernization to Regulation

FDA Issues Three Guidances, Including Long-awaited CDS Guidelines

The Feds Just Cleared a Major Roadblock for Digital Health

FDA Unveils Clinical Decision Support, Medical Device Guidance

 

International Pilot Program Tests Whether People Would Be Willing to Exchange Clinical Laboratory Test Results and Photos of Their Bodies for Cryptocurrency

Developers believe participants will be interested in controlling how their private health data is provided to medical laboratories, drug companies, research organizations, and the federal government, while also earning an income

Bitcoins for blood tests, anyone? A new venture is examining the idea of exchanging cryptocurrency, a digital asset, for the results of weekly clinical laboratory tests and photographs of body parts from healthcare consumers. If successful, in a couple of years, people might be able to earn a “basic income” from selling their private health data to pharmaceutical companies, medical laboratories, research organizations, the federal government, and more.

Insilico Medicine, a Baltimore developer of artificial intelligence (AI) solutions for research and pharmaceutical companies, and the Bitfury Group, a blockchain technology company based in Amsterdam, Holland, are working together on the project they call Longenesis, a blockchain-based platform that uses AI to collect, store, manage, and trade data, such as medical records and health data.

Marketing Human Life Data

The two participants presented their novel idea this past November in Taipei, Taiwan, at the TaiwanChain Blockchain Summit. They published their report in Oncotarget, an open-access biomedical journal that covers oncology research. The authors of the paper believe blockchain and AI technologies could support patients and physicians in working with medical data.

“There are many companies engaged in the marketplaces of human life data with billions of dollars in turnover. However, the advances in AI and blockchain allow returning the control of this data back to the individual and make this data useful in the many new ways,” Alex Zhavoronkov, PhD, founder of Insilico Medicine, told Cryptovest.

“I would love to live in a world where I’m motivated to regularly take all kinds of medical tests for free, I get the data back, and I will be able to sell this data to the marketplace, and I earn all kinds of goods and services—primarily health related,” Zhavoronkov told Motherboard.

Alex-Zhavoronkov-PhD

Alexander Zhavoronkov, PhD, Founder and CEO of Insilico Medicine, told Motherboard, “Right now, it’s difficult to predict. But I think that if [users] submit blood tests, pictures, transcriptomes let’s say on a weekly basis, you probably will be able to earn a good universal basic income.” Zhavoronkov is describing a new business model involving clinical laboratory testing. (Photo copyright: Insilico Medicine.)

Exchanging Human Biomarkers for Digital Coin

Combining blockchain and AI technologies is one of the many emerging technological advances emerging to enhance the medical and pharmaceutical industries.

“Recent advances in machine intelligence turned almost every data into health data. The many data types can now be combined in the new ways: one data type can be inferred from another data type and systems learning to optimize the lifestyle for the desired health trajectory can now be developed using the very basic and abundant data,” noted Polina Mamoshina, research scientist at Pharma AI, a division of Insilico Medicine, during the company’s presentation at TaiwanChain. “Pollen, weather, and other data about the environment can now be combined with the human biomarkers to uncover and minimize the allergic response among the myriad of examples. People should be able to take control over this data.”

Because pharmaceutical companies rely on data mining to obtain individual demographic information and medical records, the growth potential for this type of product is huge.

Clinical Laboratory Test Results Earn LifePound Tokens

Longenesis is still being tested, but Zhavoronkov hopes it will be ready for the public within the next two years. The plan is to utilize blockchain technology to collect and store patient medical data in exchange for their cryptocurrency, known as LifePound.

According to the Longenesis website, “Longenesis is a marketplace, which uses personal health data, transformed into a LifePound token. LifePound is used inside a marketplace as a monetary system, powered by Exonum blockchain technology to keep data secure and transparent. Tokens are distributed between Longenesis marketplace members and are used for transactions between the following elements:

  • Developers;
  • Users;
  • Data providers;
  • Customers; and the,
  • Stock cryptocurrency market.

The developers believe the “Longenesis Data Marketplace will be able to provide new insights in the fields of healthcare research and development. It will provide analysis and recommendations to pharmaceutical companies to help develop new drugs.”

It’s too early to predict whether Longenesis will be successful and catch on with the public. However, the popularity of cryptocurrency, and the opportunity to earn an income from one’s clinical laboratory data, could encourage individuals to participate in this type of endeavor.

In addition, this is a highly unusual and unexpected approach to encourage consumers to undergo regular medical laboratory testing in order to earn payment by a digital currency. It is a reminder of how rapid advances in a myriad of technologies are going to make it possible for entrepreneurs to create new business models that involve clinical laboratory tests and the data produced by such tests.

—JP Schlingman

Related Information:

This Biotech Company Wants You to Give It Selfies and Blood Tests in Exchange for Cryptocurrency

A Decentralized Medical Record Marketplace Powered by Human Data

Blockchain, AI Could Spur Biomedical Research, Insilico Medicine Says

Converging Blockchain and Next-generation Artificial Intelligence Technologies to Decentralize and Accelerate Biomedical Research and Healthcare

Blockchain, Explained

Clinical Laboratory Accuracy and Quality Is under Increased Scrutiny as Precision Medicine Puts Diagnostics in the Spotlight

As the public gains awareness of the role clinical laboratories play in modern healthcare, increased engagement and understanding of the technology underlying many of these advances could create risk for labs without transparent reporting protocols to both patients and the public

In recent years, consumers have continually raised the bar in their expectation of quality when they interact with the healthcare system. Not only do patients expect providers—including clinical laboratories and anatomic pathology groups—to improve regularly over time, but the public has even less tolerance for medical errors of any type. Thus, a recent NPR story is one more warning to the medical laboratory profession that it should be devoting resources and effort to improving quality.

Today’s healthcare consumers and patients are more educated about and involved in the care process than ever before. While the exact science and skills may not interest the general public, the technologies underpinning much of the shift toward personalized medicine (AKA, precision medicine) are the same technologies that created the always-connected, digital lifestyles seen around the world.

With this, comes a level of scrutiny and questioning from the public that clinical laboratories or anatomic pathology groups would not have experienced even just a decade ago.

Mounting Scrutiny of Medical Laboratories and Healthcare Professionals

A recent segment on NPR’sAll Things Considered” highlighted this trend and questioned the quality control standards behind many of the procedures powering current testing. The segment also questioned the impact quality control has on the quality of biobanks used to research and create future technologies and tests.

Pathologist Richard Friedberg, PhD, Medical Director of Baystate Reference Laboratories and former president of the College of American Pathologists, told NPR, “We need to be sure that the stuff [doctors and researchers are] looking at is valid, accurate, reliable, and reproducible … If it’s garbage in, it’s garbage out.”

The story highlights improved standards and guidelines surrounding immunohistochemical (IHC) HER2 tests in the early 2000s. In 2007, The New York Times questioned the reliability of the tests, based on studies presented to the American Society of Clinical Oncology the week prior.

In response, the American Society of Clinical Oncology and the College of American Pathologists released guideline recommendations outlining the exact standards required to reduce assay variation and ensure that data produced is accurate and reproducible. NPR’s coverage claims this is the only test with such strict guidelines.

“I don’t think physicians think this way about their entire medical system,” Carolyn Compton, PhD, CMO of the National Biomarker Development Alliance, CMO of the Complex Adaptive Systems Initiative, and professor of Life Sciences at Arizona State University, told NPR. “I don’t see how we’re going to get precision medicine at the end of the day when everything under the hood is so imprecise.”

Atul-Butte-PhD

Atul Butte, PhD (above), Director of the Institute of Computation Health Sciences at the University of California-San Francisco, presents an alternate side to Compton and Friedberg’s views in the NPR article. “I am not a believer in garbage-in, garbage out at all,” he said. “I know that no one scientist, no one clinician or pathologist is perfect … But, I’d rather take 10 or 100 so-called mediocre data sets and find out what’s in common, then to take one who says they’re perfect at doing this kind of measurement.” (Photo copyright: Santiago Mejia/San Francisco Chronicle.)

 

When data and previous research powers much of the innovation taking place across the modern healthcare landscape, the accuracy of said data would seem critical. Yet, without standards in place, there’s not always safeties by which to verify sample integrity and other critical concerns.

Late last year, Dark Daily reported on a study published in PLOS ONE from Radboud University in the Netherlands questioning the accuracy of more than 30,000 published scientific studies that contained misidentified or contaminated cell lines. Guidelines, such as those created for IHR and FISH HER2 testing, provide standards intended to prevent such issues from occurring or detecting them when they do occur.

Quality versus Quantity: A Gamble Worth Taking?

Apart from challenges with healthcare reform and the regulatory landscape surrounding precision medicine, medical laboratories also must struggle with the challenges of gleaning and maintaining useful, accurate information from an ever-growing trove of data produced by analyzers and assays.

Yet, these mediocre datasets include the results of tests that carried a potentially significant impact on patient lives. In the first two weeks of February alone, both the St. Louis Post-Dispatch and The Telegraph published stories related to erroneous testing related to cancer and the potential impact on the clinical laboratories involved and the patients tested.

Increased coverage shows that the world is watching what goes on in medical laboratories, hospitals, and data centers as healthcare continues to evolve. Clinical laboratories must move forward with this in mind or risk pushback and questioning from the public. Transparency regarding standards, and reporting information to patients surrounding testing or concerns, might effectively address this rising trend.

“We are moving faster and faster and faster as this whole precision medicine train is moving down the track,” Tim Allen, MD, Laboratory Director at the University of Texas Medical Branch Department of Laboratory Services, told NPR. “I suspect standardization of these things is going to become a reality much quicker than I would have expected even a few years ago.”

That quality control issues in anatomic pathology are considered newsworthy by no less than NPR is a sign of increased public attention to the quality of lab testing. The story was written to educate the public about the gap that exists in the quality control of anatomic pathology testing. All of this is consistent with the trend for providers to be transparent and report their quality metrics to the public, including patients.

—Jon Stone

Related Information:

Hormone Receptor Testing Volume 1: Investigation and Findings Commission of Inquiry on Hormone Receptor Testing

Precision Medical Treatments Have a Quality Control Problem

HER2 TESTS: How Do We Choose?

Cancer Drug May Elude Many Women Who Need It

American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer

Impact of Electronic Health Record Systems on Information Integrity: Quality and Safety Implications

His Doctor Said It Was Cancer. It Wasn’t. But the Lab Mix-Up News Came Too Late.

Up to 60,000 Cancer Test Results May Have to Be Reviewed After Women Wrongly Given the All-Clear

Over 30,000 Published Studies Could Be Wrong Due to Contaminated Cells

Netherlands University Researchers Question Validity of More Than 30,000 Published Scientific Studies; Findings Have Implications for Medical Laboratories

Anatomic Pathologists Who Work in Independent Reference Laboratories Can Now Provide Diagnostic Services for CLIA-Approved Hospitals without Need for Additional Credentialing and Privileging

The Joint Commission’s recent alteration to the Introduction to Leadership (LD) Standard LD.04.03.09 makes it easier for off-site and independent reference laboratories to service CLIA-hospitals and other CLIA-approved healthcare facilities

Anatomic pathologists working for reference laboratories can now provide diagnostic services to hospitals, critical-access hospitals, and ambulatory care facilities in the US based on the organization’s Clinical Laboratory Improvement Amendments (CLIA) status, rather than the usual credentialing and privileging. The Joint Commission (TJC) made the change effective January 2018.

According to a TJC press release, “Clinical Laboratory Improvement Amendments (CLIA) regulations 42 CFR 493.1351 through 493.1495 outline specific and rigorous competency requirements for laboratory personnel, including requirements for pathology services and its subspecialties. But because pathologists practicing in the US are required to comply with these requirements, Joint Commission-accredited organizations that seek the services of pathologists within independent reference laboratories (that comply with CLIA regulations) can safely presume that the pathologists are qualified and competent to perform all diagnostic services within their pathology practice—thus making an additional credentialing and privileging process unnecessary.”

In an interview with Dark Daily, Heather Hurley, Executive Director, The Joint Commission, and Ron Quicho, Associate Project Director and Standards Development Director at TJC, explained the reasons behind this change. “With the current CLIA requirements, the previous standard was adding unnecessary burdens and regulatory overhead to hospitals and ambulatory care organizations—especially as outsourcing continues to increase within the testing market. This update helps to reduce these burdens and streamline testing,” Hurley noted.

Quicho added, “The Joint Commission continually evaluates its standards and survey process to ensure that we are providing an accreditation service that is of the highest quality and value. That said, we made the decision to update the standards based on feedback from stakeholders and customers.”

Ron-Quicho-Heather-Hurley-Joint-Commission

Ron Quicho, Associate Project Director and Standards Development Director (left), and Heather Hurley, Executive Director (right), The Joint Commission, believe these updated standards will benefit clinical laboratories and hospitals alike. But they note, “Anytime the pathologist provides professional services and consultation in the same laboratory where the specimen was collected or prepared, credentialing and privileging would be required. The exception for credentialing and privileging only applies when pathology services are provided off-site, such as at a reference laboratory.” (Photo copyrights: LinkedIn/The Joint Commission.)

Joint Commission Reduces ‘Unnecessary Burden’ on Hospitals, Ambulatory Care Facilities

Reference testing and CLIA have been a common part of the diagnostics and medical laboratory landscape for decades. According to Quicho, the key components of The Joint Commission’s decision include:

  • Increasing numbers of independent practitioners and consultants;
  • Reference laboratories often seek pathology services from another laboratory for certain testing and screening. As such, it is unclear if the credentialing and privileging requirements extend to these secondary pathology services, since they may also be providing the interpretation;
  • It would be virtually impossible to credential and privilege all pathologists at a reference laboratory whose services result in patient care decisions, since interpretations are made not only in anatomical (surgical) pathology but in many areas of clinical pathology; and,
  • Reference laboratories employ hundreds of pathologists and healthcare facilities and cannot be sure of who provides interpretation on specimens that are sent out.

It is important to understand that the exclusions in this latest TJC update only apply when testing is performed offsite of the ordering facility. In their press release, TJC stated, “A reference laboratory is a laboratory contracted for testing that is owned and operated by an organization other than the organization referring the testing … When the pathologist provides his or her professional service, including consultation in the same laboratory or organization where the specimen was collected or prepared, credentialing and privileging is required.”

TJC Change Helps Clinical Laboratories and Hospitals Alike

Hurley points out that the January 2018 edition of TJC’s “Comprehensive Accreditation Manuals” already includes the updated standard and that participating ambulatory care, critical access hospitals, and hospitals were updated regarding the changes. The 2018 print editions will also include this change.

She also points out that exclusion from the standard’s requirements does not prevent hospitals from still requiring credentialing or privileging for their internal compliance processes or regulations. Quicho also emphasizes the importance of continuing to meet all CLIA requirements surrounding competencies, training, and personnel qualifications.

The TJC update should result in less action required by both clinical laboratories and hospitals alike—a welcome change for a market in a state of near-constant flux due to healthcare reform and increased regulation. The reasoning behind the decision also highlights current trends amongst pathology groups and clinical laboratories concerning scaling through consolidation and outsourcing among hospitals, ambulatory care organizations, and critical care providers.

—Jon Stone

Related Information:

Now in Effect: Change to Requirements for Credentialing, Privileging of Independent Pathologists

Credentialing and Privileging of Independent Pathologists

The Joint Commission No Longer Requires Credentialing and Privileging of Independent Pathologists—Four Things to Know

Former Hershey Medical Technologist Floyd Benko Sentenced to 15 Months in Prison for Failing to Follow Procedures when Performing Clinical Laboratory Tests

The indicted medical laboratory technician will also be required to pay back more than $69,000 to Hershey Medical Center

It what may be a unique first for the clinical laboratory industry, a medical technologist in Pennsylvania has been found guilty of a criminal felony for failing to perform certain cancer genetic tests according to approved protocols. The judge has sentenced the medical technologist to 15 months in prison and repayment of almost $70,000 in restitution.

Dark Daily reported on earlier developments in this case in 2017. Medical technologist Floyd Benko was indicted in 2015 after pleading guilty to false statement charges stemming from his work with genetic testing at Hershey Medical Center (HMC) between November 2014 and April 2015. Now, Benko has been sentenced to nearly 15 months in prison after pleading guilty to false statement charges.

US Middle District Judge Yvette Kane sentenced Benko to 15 months in prison with three years of supervised release following his prison term. He must also make restitution to HMC in the amount of $69,742 related to retesting of the gene mutation tests he previously performed in which the results were found to be inaccurate.

The sentence required Benko to report to the Pennsylvania Bureau of Prisons on January 22, 2018.

Failure to Follow Protocols Leads to Faulty Results and Eventual Sentencing

The charges levied against Benko relate to DNA gene mutation tests performed by him on behalf of HMC for 124 advanced-stage cancer patients. According to a Department of Justice press release, the genetic testing included:

“Benko failed to perform the assays in the manner called for by Hershey’s standard operating procedures,” the press release states. “Subsequent retesting of the patients during summer 2014, revealed that 60 of the 124 patients had assay results discordant with results obtained by two outside medical laboratories.”

Unusual Application of Federal Fraud Statute

Dark Daily’s previous coverage provides a detailed timeline of events leading up to Benko’s guilty plea.

Court filings state that in late 2013, a treating physician at HMC noted discordant results for tests when compared to a patient’s clinical profile. The physician resubmitted the test to an outside lab and received results that differed from those of Benko’s test.

This led to a request from HMC supervisors for Benko to repeat the test. Again, results differed from the outside laboratory. When supervisors asked for access to the tissue samples used for the test, Benko could not provide them.

Penn State Milton S. Hershey Medical Center (above) where in 2013 to 2014 Floyd Benko, a 60-year-old research technologist, improperly conducted 124 gene mutation clinical laboratory tests and then lied about it to cover up his lack of following standard operating procedures. (Photo copyright: PennLive/Paul Chaplin.)

Standard operating procedures (SOPs) for the tests in question—procedures Benko himself helped to create in conjunction with HMC—required preservation of all tissue samples. They also required the use of a Thermo Scientific NanoDrop 2000 spectrophotometer—a piece of equipment that Benko did not acknowledge using.

With Benko unable to provide samples, HMC triggered an FBI investigation into testing practices by Benko. The investigation yielded 125 tests for which samples were not preserved. Repeat testing by two outside medical laboratories—at HMC’s expense—resulted in 60 assay results returned that were discordant with Benko’s original findings.

Benko eventually resigned from HMC. He later attempted to explain the discordant results in two separate letters to HMC supervisors. However, in July 2015, a federal grand jury returned an indictment: one count of healthcare fraud and two counts of making false statements in healthcare matters to HMC.

Copies of court filings available at Leagle show that Benko initially disputed the charges using four primary arguments and requested case dismissal. These arguments were eventually denied by Kane. “In refusing to dismiss the charges against Benko, Kane rejected his arguments that his alleged actions don’t constitute a crime, especially since he didn’t profit financially,” noted PennLive. “The judge did, however, characterize the Benko case as an ‘unusual application of the federal healthcare fraud statute.’”

After denial of his dismissal, Benko entered a guilty plea to false statement charges in July 2017. Follow-up coverage from PennLive explained that Benko’s plea agreement included a stipulation that advised a sentence of up to 18 months—of which he received 15 months. At the time of sentencing, the final charge appears to be one count of making false statements.

Establishing Protocols and Ensuring Accuracy in Medical Laboratory Testing

Anatomic pathology and medical laboratory testing is an increasingly important part of the modern healthcare system. Both value-based care models and personalized medicine rely on lab results to help improve outcomes and tailor treatments to the individual patient profile.

By failing to follow SOPs when performing these clinical laboratory tests, Benko potentially jeopardized the treatment outcomes and health of more than 100 patients and also created liability concerns for the laboratory in which he was employed.

As highlighted by Benko’s sentence, the impact from this case was not limited to the lives of more than 100 patients. It also affected both the reputation of HMC and their financials—requiring nearly $70,000 in additional spending for the flawed assays—and to confirm the results of suspect tests performed by Benko. And, this does not account for the time and monetary costs related to the investigation and prosecution of the case, or public relations work surrounding the case.

As test volumes continue to increase and lab liability continues to take the spotlight, it is essential that clinical laboratories, anatomical pathology groups, and other diagnostic service providers maintain effective protocols and procedures to ensure the accuracy of test results. And they must establish comprehensive documentation and compliance programs that create accountability and highlight concerns quickly to ensure both patient and laboratory safety.

—Jon Stone

Related Information:

U.S. v. BENKO No. 1:15-cr-00159

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