How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Decoding Quality Terminology
There is a lot of talk about quality these days, but there is often confusion around quality terminology
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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OIG Work Plan Monthly Review: August 2017
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Compliance Perspectives: Private Sector Joins the Battle against Lab Fraud
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Lean Six Sigma is Not Quality
By Jennifer Dawson, MHA, LSSBB, DLM(ASCP) bio
Now before the entire industry lynches me for the sacrilege of the title of this article, let me explain what I mean. I have known Lean Six Sigma skeptics and outright haters and trust me…
Consortium Releases New Interoperability Standard for Lab IT Systems
From - G2 Compliance Advisor
With the release of a new information technology (IT) standard, the dream of true interoperability of electronic health care information has gotten…
OIG Switches from Semi-Annual to Monthly Work Plan Strategy
From - G2 Compliance Advisor
New OIG Work Plans every six months are a thing of the past. In June, the agency announced plans to update its Work Plan website monthly. The self-proclaimed…
By the Numbers: Lab Injury and Exposure Data
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Finding information about the number of Laboratory Acquired Infections (LAIs) and other laboratory injuries in the United States is difficult…
Theranos and Walgreens Bury the Hatchet—For Now
From - G2 Compliance Advisor
It all looked so promising back in 2015. Privately-held Theranos was poised to usher in a new era of diagnostics with its revolutionary fingerprick technology for…
Employment Law Update for August 2017
By Mike O'Brien bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…