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…)
Mar 11, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Reviewing medical laboratory test results online is a popular resource among consumers, says a different study by Kaiser Permanente
More than half of patients and consumers have trouble understanding their health information, along with the steps needed to further improve their health, according to a recent study conducted by HealthMine. This gap in consumer understanding represents a great opportunity for clinical laboratories and pathology groups that want to forge stronger bonds with patients and consumers.
In its survey of more than 7,200 healthcare consumers about their health knowledge, HealthMine determined that about 52% of consumers find it difficult to understand their health information and/or what is required of them to maintain or improve their health.
Knowledge of one’s health, or the health of a loved one, is critical to the management of chronic diseases and other health conditions. In this Internet age of patient portals and mobile health devices, the assumption is that most folks would be comfortable using the new technologies. Apparently, this is not the case. At least not among those HealthMine polled. (more…)
Nov 30, 2015 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Researchers determined that as many as nine successive capillary blood drops must be collected and tested to achieve results that would be comparable to testing with venous blood
A new study is raising questions about the implications of using fingerprick blood samples for point-of-care tests. Done by researchers at Rice University’s Department of Bioengineering, the study suggests clinicians use measurements with caution when assessing patients’ conditions based on the results of clinical laboratory tests using a single drop of capillary blood collected by fingerstick.
Pathologists and clinical laboratory scientists were quick to call attention to the study, based on the press release Rice University issued. That’s because, for almost 30 years, medical laboratories have struggled to correlate the results for such biomarkers as glucose. It is common for capillary blood specimen collected by finger stick and tested on a point-of-care device to produce different results for the same patient when compared with that of a venous specimen tested on the automated, high-volume analyzes in a central laboratory. The Rice researchers offer useful insights about such variation. (more…)
Sep 23, 2015 | Instruments & Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Antibody validation standards would help ensure reproducibility of research studies and improve the consistency medical laboratory test results
As science and industry gets better at measuring things and assessing quality, the acceptable standard often comes into question. This seems to be happening with antibodies, the most common reagents used in diagnostics, clinical laboratory diagnostic tests, and medical research. In many cases, the end result is that companies and their suppliers must use new technologies and quality methods to revise the “old way” and create products that have measurable better quality.
The techniques currently used to validate antibodies is the topic of a recently-published scientific paper. The authors of a paper published in the March, 2010, issue of Biotechniques pointed out, antibody validation and standardization ensure study reproducibility, which is critical to accuracy. And yet, no standard guidelines define how these important biological tools should be validated prior to use.
Thus, researchers participating in a recent webinar, presented by The Scientist expressed concern that—without improved antibody validation and standardization—the accuracy of published research is in question and diagnostic test results, such as those produced by medical laboratories, will continue to be inconsistent. (more…)
Aug 12, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Among all medical specialties, pathologists have a high rate of participation in both Medicare reporting programs
Many pathologists are aware of Medicare’s Physician Quality Reporting System (PQRS) and Electronic-Prescribing Incentive (e-prescribing) Program. But what is less known is that up to 40% of eligible doctors nationwide are opting to not participate and thus get paid less money from the Medicare program.
That high rate of non-participation is not true for one group of practitioners, however. Pathologists had the highest participation rate (78.7%) among specialties in PQRS and recorded the fourth-highest participation rate (80.3%) in the e-prescribing program! Pathologists received an average incentive of $246 for the 2013 e-prescribing program and $384 for the 2013 PQRS program. (more…)
