Oct 16, 2015 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
A related issue is the growing use of contract sales representatives to sell clinical laboratory and pathology testing services and whether such arrangements violate federal compliance requirements
More and tougher payer audits are hitting an expanding number of clinical laboratories and anatomic pathology groups in recent months. Across the nation, experts in medical laboratory billing and collections are reporting that health insurers are auditing for a host of issues, several of them unexpected and without precedent.
Three types of clinical lab companies seem to be the highest-profile targets for these intense payer audits. Reports identify lab companies offering toxicology and pain management testing as undergoing rigorous audits. Medical lab companies with proprietary molecular diagnostic assays and genetic tests are known to have been audited in this manner. Some anatomic pathology groups are believed to have also experienced such audits. (more…)
Oct 9, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Houston newspaper breaks story about failure of many medical laboratories to report certain test results to public health laboratories, thus delaying investigations of disease outbreaks
Once again, problems with the existing system of medical laboratory testing made national news. This time, the key players were a maker of ice cream, clinical laboratories, and public health laboratories.
It was a Houston newspaper that first reported a pattern of failures in how clinical laboratories and public health laboratories communicate as clinical labs identify patients who tested positive for listeriosis, a bacterial infection most commonly caused by Listeria monocytogenes. These test results were associated with the recent listeriosis outbreak that was connected to Blue Bell ice cream.
Blue Bell, Listeria, and Lab Failures
On July 18, 2015, the Houston Chronicle reported on David Philip Shockley. He is a retirement community administrator who believes he contracted listeriosis by eating Blue Bell ice cream. (more…)
Oct 7, 2015 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
In a poll of 2,300 physicians, more than 66% responded that they would not support giving patients access to their full medical records
In recent years, a new federal law made it mandatory that medical laboratories provide patients with access to view their lab test results. However, many healthcare providers continue to resist the concept of allowing patients to have access to their full clinical record.
SERMO Poll Receives Mixed Results
This fact is supported by a recent poll of 2,300 doctors. More than two-thirds of physicians (66%) participating in the survey said that they are reluctant or opposed to giving patients access to their complete medical records, according to a Forbes report.
The poll was conducted by SERMO, a global online social network for doctors. SERMO has 305,000 U.S. members, as well as about 38,000 U.K. members. The poll asked: “Should patients have access to their entire medical record—including MD notes, any audio recordings, etcetera?” The results were mixed: (more…)
Oct 5, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
This breakthrough in technology miniaturization holds great promise for improving public health, but portends a disruptive future ahead for the medical labs
Is the medical laboratory industry ready for a handheld device that can do immunoassay testing without requiring any stored energy? The secret of this device, already undergoing field trials in Rwanda, is that it uses a smartphone accessory, or “dongle,” to capture and transmit the results of the lab tests.
This innovative smartphone device accurately diagnoses HIV and syphilis with a finger prick of blood and displays the results on the smartphone screen within 15 minutes, according to a Columbia Engineering News Service report.
An Ideal Device for Field Work in Resource Poor Areas
It’s mobile and inexpensive, making it an ideal diagnostic tool for use in poor, remote regions of the world. According to World Health Organization (WHO) statistics, the highest percentages of all sexually transmitted disease (STD) cases occur in developing and underdeveloped nations. (more…)
Sep 25, 2015 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
Researchers are concerned about the lesser-known genes included in the test and also point out that little published research exists to support use of these genes for clinical laboratory testing
Gene-panel tests for inherited cancers were scrutinized by a group of 17 prominent international genetic researchers in a study published by the New England Journal of Medicine (NEJM) this summer titled “Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk.” These experts pointed out that, for many of the genes included in these test panels, there remains much uncertainty about their role in various cancers and other diseases.
What will be of greatest interest to pathologist, Ph.D.s, and medical laboratory professionals currently performing molecular diagnostics assays and genetics is that these experts proposed greater regulation of unvalidated gene-panel tests for inherited cancers. In the NEJM, the authors provided some examples of genetic tests, such as those offered by Myriad Genetics, Inc. (NASDAQ:MYGN), Ambry Genetics, Invitae (NYSE:NVTA), and Illumina, Inc. (NASDAQ:ILMN) and noted that risks posed by many mutations occurring on these panels are unknown.
These panel tests can include more than 100 genes, 21 of which are an indication of breast cancer, including BRCA1 and BRCA2, stated the paper. (more…)
Sep 16, 2015 | Coding, Billing, and Collections, Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Experts believe compressive sensing could find wide application in medical laboratory and pathology testing, particularly where large amounts of data are generated
Pathologists and medical laboratory managers may soon be working with a new tool in their labs. It is called “Compressive Sensing” (CS) and it is an innovative mathematical approach that quickly and efficiently gets an answer by sampling large volumes of a data.
Currently compressive sensing is used in medical imaging technology. CS reduces radiation and speeds up imaging diagnostics. Some experts familiar with this technology believe that it can be used in those clinical laboratories that are working with new diagnostic technologies that generate large volumes of data. CS could dramatically reduce times to analyze results and lower the cost of expensive tests like whole-genome sequencing. (more…)
