Apr 14, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement
Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal
Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.
In a letter to Theranos executives, CMS said it is prepared to:
• revoke the company’s CLIA certificate;
• impose a fine of $10,000 per day;
• suspend and cancel the lab’s approval to receive Medicare payments; and
• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.
Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (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…)
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…)
Sep 21, 2015 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Pathology, Laboratory Testing
This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology
Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In addition, some have published their critiques of the start-up medical laboratory company in well-respected medical journals.
One question these clinical pathologists and laboratory directors ask is why Theranos has so far been unwilling to provide more information about the lab testing technology it uses to deliver medical laboratory test results to patients and their referring physicians. Even as the company has declined to speak to the medical laboratory profession, Theranos has mounted a major public relations campaign designed to make a big impression on investors, business partners, and most recently on health insurers.
The clinical laboratory company in Palo Alto, Calif., gets plenty of attention because it claims to have disruptive technology that will allow it to perform medical laboratory tests equivalent to the current standard of care. Theranos says it can do this using a capillary specimen and return results in four hours, while charging a price that is just 50% of Medicare Part B lab test fees. Given these assertions, it is natural that pathologists and laboratory scientists who perform tests for patients, are curious about the scientific basis of Theranos’ proprietary diagnostic technology and what evidence Theranos has developed to support its claims of comparable accuracy and reproducibility. (more…)
Aug 17, 2015 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
By placing this low-cost, disposable device developed at the University of Wisconsin-Madison on their arms or abdomens, patients can collect their own blood at home in minutes
For more than two years, the nation’s media have been captivated by Theranos CEO Elizabeth Holmes’ vision of offering patients who need blood tests a finger stick collection instead of a venipuncture. Meanwhile, in research labs across the nation, there are credible efforts to develop ways to collect medical laboratory test specimens that require no needles at all.
On such effort may soon enter the market. It is an innovative, needleless blood-collection device called HemoLink developed by a research team at the University of Wisconsin-Madison. Users simply place a device with the diameter of a golf ball against their arms or abdomens for two minutes. During that time, the device draws blood from capillaries into a small container. Patients would then mail the tube of collected blood to a medical laboratory for analysis.
This non-threatening device is ideal for children. However, patients who require recurrent blood tests to monitor health conditions would also benefit, as it would save them frequent trips to clinical laboratories for blood draws using traditional needle-stick methods. (more…)
