Sep 30, 2016 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
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…)
May 4, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency
National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups.
Over the past 30 months, Theranos has regularly asserted that its laboratory-developed tests (LDTs) were under review by the Food and Drug Administration (FDA). For example, in an interview published in the December 14, 2014, issue of The New Yorker, Theranos Founder and CEO Elizabeth Holmes stated, “We believe that to realize our vision we must operate at the highest levels of excellence… And the FDA’s stamp of approval is seen as an indicator of the quality of a product.”
Thus, it would be ironic if the problems in the quality of clinical laboratory tests uncovered by federal CLIA inspectors at the Theranos lab facility in Newark was used by the FDA to justify their intent to regulate LDTs. The FDA has already released a report to the public that identified instances where laboratories running LDTs were alleged to have reported inaccurate lab test results to patients and their physicians. (more…)
Aug 19, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Testing, Management & Operations
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…)
Feb 9, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Three out of five NIPT laboratories returned normal or negative test results for samples taken from non-pregnant women in undercover test performance assessment
Clinical laboratory companies that offer genetic tests may want to be on the alert. Secret shoppers are submitting specimens for the purpose of assessing the quality, the accuracy, and the clinical relevance of the proprietary medical laboratory tests they perform.
One such report was published in GenomeWeb under the title “Undercover Assessment of Five Commercial NIPT Labs Points to Need for Better Quality Control.” The goal of the report was to emphasize the need for standards to ensure quality and accuracy of molecular assays and genetic tests.
This report discussed results from an undercover performance assessment of five commercial laboratories, each of which offers Non-Invasive Prenatal Tests (NIPTs). GenomeWeb reported that three test results reported normal or negative test results for a female fetus, despite the fact that the samples submitted had been taken from non-pregnant women. (more…)
Jan 5, 2015 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Health plan sets no new date for BeaconLBS claims-payment decisions but promises 30-days’ notice before making decisions on claims payment
Physicians, pathologists, and clinical laboratories in Florida got a late Christmas present last week. UnitedHealthcare (UHC) (NYSE:UNH) postponed the date when its medical laboratory benefit-management pilot program in Florida, administered by BeaconLBS, would affect claims payments.
This was welcome news, because, beginning January 1, if physicians serving UHC patients had failed to use the BeaconLBS system to obtain pre-notification or pre-authorization for 82 medical laboratory tests, the physicians or labs performing the tests would not be paid by UHC—nor could clinical labs and pathology groups in the UHC provider network bill patients for these tests. (more…)
