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

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

Hosted by Robert Michel
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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

Genomic Study Reveals Role of Human Papillomavirus in Cervical Cancer and Identifies Novel Therapeutic Targets for the Disease

Findings may help physicians tailor cervical cancer therapies to specific gene mutations and improve the accuracy of diagnostic screening tests for this disease

New scientific knowledge about the role of human papillomavirus (HPV) in the growth of cervical cancer is creating excitement within the medical community. Among other things, these findings could encourage more widespread vaccination against HPV. That in turn would lead to reduced Pap smear testing by pathology laboratories over time.

For these reasons, cytopathologists and cytotechnologists will be particularly interested in the research findings that were published as a first-ever, international genomic study of cervical cancer, which was published online December 25, 2013, at Nature.com. Researchers discovered that the location where HPV integrates itself into the human genome, is where it causes amplified gene expression that promotes and elevates mutated gene activity that may cause cervical cancer to develop. (more…)

Pathology Testing for Molecular Genetics “Not Ready for Prime Time”

Experts at National Comprehensive Cancer Network conference voice opinions

It may surprise many pathologists and clinical laboratory managers to learn that a number of prominent healthcare leaders recently voiced significant reservations about the current status of molecular genetics testing. In their view, clinical pathology laboratory testing that incorporates genetic and molecular technologies needs further refinement, improved billing codes, and additional regulation before it can fulfill its potential to be a precise diagnostic tool.

That was the conclusion reached by a panel of distinguished physicians representing healthcare organizations, pharmaceutical giants, insurance companies, and the government at this year’s annual National Comprehensive Cancer Network (NCCN) conference.
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Genentech Scientists Zero in on “Liquid Biopsies” as a Way to Replace Tissue Biopsies in Breast Cancer

Surgical pathologists could gain new tool to diagnose many types of cancers


It might soon be possible to determine the HER2 status of breast cancer patients from blood samples rather than tissue biopsies. If this new technology proves feasible, it would give surgical pathologists and medical laboratories a different, and possibly less complex, methodology to use when assessing a case of breast cancer.

In its report about the study, Medscape Medical News, wrote that “HER2 status derived from circulating tumor cells (CTCs) from breast cancer patients was generally concordant with that derived from tumor tissue” and that “CTCs could prove to be an alternative to biopsies for assessing tumor tissue for biomarker status.”

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Georgetown University Hospital Suspends Testing at One of Its Pathology Laboratories

Testing ceases following July 19 inspection by officials from CMS and CAP


Last Friday, The Washington Post broke the news that Georgetown University Hospital (GUH) had closed the pathology laboratory that performed certain breast cancer tests. The action—described as an “unprecedented” suspension by GUH Chief Medical Officer Stephen Evans, M.D.—was taken in response to an investigation of the pathology laboratory by federal officials.

The closure of the laboratory followed an inspection on July 19, 2010 by officials from the Centers for Medicare and Medicaid Services (CMS) and inspectors from the College of American Pathologists (CAP). Hospital officials say the molecular testing laboratory in question will be closed as long as four to eight weeks. During this time, specimens are being referred to outside laboratory testing sources.

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