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
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Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions

Test ordering and results interpretation can confuse the public says Dartmouth Institute, which is why some clinical laboratories limit the types of lab tests that people can request

Giving consumers direct access to medical laboratory testing continues to be a subject of some controversy. One factor in this debate is Theranos, which brought much attention to direct access testing, followed by extensive news coverage in recent months of its problems with reporting accurate clinical laboratory test results.

Concerns about allowing consumers to have direct access to lab testing were the subject of a recent National Public Radio (NPR) Shots Health News story. Several medical experts were interviewed and described why they had concerns about direct access testing (DAT).

One such expert is H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine at The Dartmouth Institute (Dartmouth). According to Welch, DAT could contribute to over-diagnosis and give people an inaccurate impression of what good health actually means. (more…)

More Clinical Laboratories and Genetic Testing Companies Are Sharing Gene Sequencing Data That Involve Variations

The National Institute of Health’s ClinVar public database of genetic variation is demonstrating good accuracy, and a handful of clinical labs are learning to share and review this relatively small genetic database

In the analysis of genomic variants, data sharing is proving to be an important tool for researchers, scientists, pathologists, and clinical laboratory scientists.

Accessible databases like ClinVar, which was launched by the National Institute of Health (NIH) in 2013, have emerged to aggregate genetic sequencing with acceptable results. ClinVar exists to meet the needs of the medical genetics community. It collaborates with organizations to make pertinent genetic information available.

ClinVar is an archive of compiled data relating to genotype and phenotype variations among humans. Through this database, individuals can present and peruse submissions regarding variants found in patient samples.

ClinVar is averaging about 6,000 submissions per month by both commercial laboratory companies and reference labs. Major contributors to the database include: (more…)

Era of Healthcare Big Data Analytics Poised for Rapid Growth; Clinical Pathology Laboratory Test Data Will Have Important Role

Tableau Software, IBM, Apple and others are building a future where analysis of clinical data guides personalized medicine, fuels research, and helps reduce healthcare costs

Use of big data in healthcare is poised to become a big business. That’s because new players in data analytics have begun to help providers and accountable care organizations (ACOs) effectively use data to improve their business operations, personalize care for patients, and/or discover new medical insights.

Because more than 70% of a typical patient’s permanent medical record consists of clinical laboratory laboratory test data, pathologists and medical laboratory scientists have a stake in the growth of big-data analytics, which are a core component in healthcare’s journey toward personalized medicine. (more…)

Clinical Pathology Laboratory Managers Use Lessons in the Best of Medical Laboratory Quality to Improve Lab Operations and Patient Safety

Nation’s largest gathering of clinical laboratory Lean, Six Sigma, and process improvement practitioners took place in New Orleans this week

DATELINE: NEW ORLEANS, LOUISIANA—More than 300 of the nation’s leading quality improvement practitioners in clinical laboratory operations came together this week to share, learn, and master the best approaches to improving the quality of medical laboratory operations in ways that improve performance and productivity even while delivering substantial reductions in cost.

The opening session of the Ninth Annual Laboratory Quality Confab featured three clinical laboratories that have aggressively used quality management methods, including Lean and Six Sigma. These are labs that are strategically committed to creating and sustaining a culture of quality and continuous process improvement. (more…)

NIST’s New Standard Genetic Reference Specimen Promises to Increase Accuracy of Clinical Pathology Laboratories Using Next-Generation Sequencing Technology

Sequencing this new DNA standard reference material enables medical laboratories to verify if their DNA test results are accurate

To reduce the variability in genetic test results that has been observed across different clinical laboratories and pathology groups, the National Institute for Standards and Technology (NIST) has introduced a new standard DNA reference. This is another step forward to improve transparency in the quality and accuracy of genetic test results produced by medical laboratories in the United States and abroad.

Even as scientists continue to identify genetic mutations that could cause various cancers and other diseases, such as Alzheimer’s and cystic fibrous, studies have demonstrated that DNA test results from the same specimen can vary depending on which medical laboratory performs the whole-genome sequencing analysis. This is partly due to variances in the technology, chemicals and processes used for the testing. Therefore, ensuring consistently reliable test results has been difficult, which could lead to inaccurate or missed diagnoses.

That is why a new standard DNA reference material developed by the National Institute for Standards and Technology has the potential to help DNA sequencing facilities to verify if their DNA test results are accurate. The new reference material, NIST RM 8398, was designed to improve the accuracy of diagnostic laboratories that analyze DNA using “next-generation sequencing” (NGS) technology. (more…)

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