Oct 28, 2015 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
FDA details findings from visits by five federal inspectors at California clinical lab company over 10 days in late August and early September; heavily redacted reports outline 14 compliance deficiencies
Two reports released Tuesday by the Food and Drug Administration (FDA) brought more bad news to Theranos, of Palo Alto, California. The clinical laboratory company has been the subject of much unwanted press coverage since October 15. In the FDA inspection reports, Theranos is required to explain or correct each of 14 “inspectional observations.”
Pathologists, clinical laboratory scientists, and in vitro company executives who take the time to read both FDA reports about the federal agency’s inspection of Theranos will find insights into how FDA assessors view the lab company’s compliance with FDA regulations and requirements. There were 14 issues described in the two FDA reports.
FDA Said Theranos Nanotainer Blood-Collection Container Is Class II Medical Device (more…)
Oct 23, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
One new federal law forbids health IT vendors and providers from deliberately blocking information-sharing with competing EHR systems
Several years deep into its effort to get physicians and hospitals to use electronic health record (EHR) systems, the federal government has yet to come up with a way to improve interoperability—the ability of EHRs to interface and communicate with other systems.
Stage one and stage two Meaningful Use guidelines have failed to successfully address the barriers preventing interoperability. Of course, clinical laboratories and pathology groups encounter this problem daily. That’s because they must build interfaces between their laboratory information systems (LIS) and the EHRs of their client physicians. The cost of creating workable LIS-to-EHR interfaces continues to be a huge burden on medical laboratories and that is why they support improved interoperability. But labs also contribute to the lack of interoperability when they enact restrictions on how lab test data can be shared with other providers and competing labs who are serving the same physicians and patients. (more…)
Oct 21, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Implantable chips could change the way doctors monitor chronic conditions and administer medications, while providing pathologists with an opportunity to analyze a new stream of diagnostic data
Researchers continue to make progress on implantable diagnostic devices that are designed to monitor the same types of biomarkers used in some clinical laboratory tests. These devices are designed to provide continuous patient monitoring and can transmit data in real time to care providers and medical laboratories.
Miniature Laboratory on a Chip
Implantable medical devices have been around for quite some time. However one particular device developed by Sandro Carrara, PhD, and Giovanni De Micheli, PhD, at the Ecole Polytechnique Federale de Lausanne (EPFL), works more like a tiny laboratory than previous generations of implantable devices.
“This is the world’s first chip capable of measuring not just pH and temperature, but also metabolism-related molecules like glucose, lactate, and cholesterol, as well as drugs,” stated Carrara in R&D Magazine. (more…)
Oct 19, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Faster sequencing speed and accuracy could fuel growth of biomarkers and lead to development of new medical laboratory tests and therapeutic drugs
Trailblazing methods used to create a treasure trove of genetic data from 100,000 Californians could pay dividends for clinical laboratories and pathology groups if similar projects identify novel biomarkers and fuel the development of new clinical laboratory tests and therapeutic drugs.
In fact, California is once again in the forefront, this time with a major program to create a big database of genetic data. The program is called the Genetic Epidemiology Research on Adult Health and Aging (GERA). It is a collaboration between the Kaiser Permanente Northern California Research Program on Genes, Environment, and Health (RPGEH) and the Institute for Human Genetics at the University of California, San Francisco (UCSF) that began in 2009. (more…)
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 12, 2015 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
In special issue, The Dark Report explains the details of what may be the biggest case of Medicare fraud and abuse in the history of the clinical laboratory business
Many clinical laboratory executives and pathologists know about the settlement last March by the Department of Justice (DOJ) of a whistleblower case involving Health Diagnostic Laboratory and Singulex. But that settlement is just one part of this major fraud case that continues to move forward and in which federal prosecutors alleged that a group of plaintiffs defrauded the federal Medicare and Tricare program out of half a billion dollars, in just 60 months!
In a court filing last summer, federal attorneys described how the lab companies and lab executives were paid $500 million between 2010 and 2014 from lab test claims submitted to the Medicare and Tricare programs. This federal lawsuit named three medical laboratory companies and three individuals as defendants. They are: Health Diagnostic Laboratory, Singulex, Berkeley HeartLab (no longer in business), BlueWave Healthcare Consultants, Tonya Mallory, Floyd Calhoun Dent, III, and Robert Bradford Johnson. (more…)
