Oct 21, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
With record attendance of 300 Lean-Six Sigma experts, this week’s conference was a high-energy event that provided medical lab professionals and pathologists with case studies of how to improve lab operations and contribute to better patient care
DATELINE: NEW ORLEANS—Yesterday was the conclusion of the 10th Annual Lab Quality Confab, which showcased innovators in clinical laboratories and anatomic pathology groups. Attendees traveled here from six different countries.
One new trend that emerged from this year’s presentations is that progressive medical labs are beginning to direct their Lean-Six Sigma, and process improvement efforts toward projects designed to add value to client physicians and hospitals. These projects include added-value features of benefit to patients and health insurers.
How Clinical Laboratories Are Succeeding with Lean Projects
This is a shift from prior years. At earlier Lab Quality Confabs, most speakers were describing how their labs were using Lean and quality management methods to improve workflow within their labs, increase the productivity of automation and staff, reduce errors, and cut costs. This was an “inside-the-lab” mindset.
That was not the case here in New Orleans this week. Yes, there were plenty of sessions where workflow redesign, productivity improvement, and cost reduction were discussed. But, at the same time, a significant number of labs doing presentations were describing projects that took the lab team outside of their laboratory to engage with physicians and nurses specifically to help them use clinical laboratory test data in ways that would improve patient care, reduce length-of-stay for hospital patients, and trigger worthwhile reductions of the cost of care. This is an “outside-the-lab” mindset. (more…)
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…)
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…)
Apr 20, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Experts say that CLIA inspections are becoming more rigorous, with inspectors taking more interest in how medical labs comply in the areas of personnel, PT, and quality control
Recent reports indicate that regulatory inspections of clinical laboratories are getting tougher. Some pathologists and medical lab managers acknowledge that they’ve had to scramble in response to the unexpected deficiencies identified by Clinical Laboratory Improvement Amendments (CLIA) inspectors following inspections of their labs.
These developments make it more important than ever that clinical laboratories work to become “inspection ready.” At the same time, it is essential that every laboratory compliance officer stay up to date with changes in how CLIA and other regulatory inspections are conducted.
Unwelcome Publicity When Medical Lab Regulators Find Deficiencies
There’s another factor at play in this unfolding story. News headlines immediately follow when federal and state lab regulators discover a problem with a laboratory and the quality of the test results that it is reporting. This raises the stakes for every lab director, because even highly respected medical laboratory organizations can find themselves at the center of unwelcome attention when the public becomes aware of inspection deficiencies. (more…)
Sep 10, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label
Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.
UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)
