By Oleg Bess, M.D. bio I don't know about you, but I was stunned by the findings from a recent report published by Coverys, a national liability insurer, which I feel should put the entire … [Read more...]
LAB SAFETY
FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings
April 3, 2018
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test—23andMe's genetic health risk report for detecting BRCA1 and BRCA2 genetic mutations most commonly … [Read more...]
LAB SAFETY
FDA Watch: Extra Time for Comments on CLIA IVD Waiver Proposals
February 27, 2018
Securing CLIA waivers for in vitro diagnostic (IVD) medical devices from the FDA is a time-consuming and cumbersome process So, the FDA won rare plaudits from the industry on Nov. 29, 2017, by setting … [Read more...]
LAB SAFETY
Emergency Staffing ABCs
January 22, 2018
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. … [Read more...]
LAB SAFETY
Fanning the Flames
October 16, 2017
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio Story #1: The fire started in the university chemistry laboratory when a research student used a flammable chemical too close to the open … [Read more...]
LAB SAFETY
By the Numbers: Lab Injury and Exposure Data
August 21, 2017
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. … [Read more...]
LAB SAFETY
Getting a new lab space? Design it for safety now and save thousands later
May 24, 2017
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio Let me tell you a story. Once upon a time, there was a laboratory manager who worked in a hospital that was designing a new stand-alone … [Read more...]
ENFORCEMENT
FDA Sends 14 Warning Letters Regarding Cancer Products
May 22, 2017
The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]
PATIENT SAFETY
Do No Harm: Diagnostic Errors and the Lab
May 2, 2017
By Jennifer (McMahon) Dawson, MHA, DLM (ASCP) bio "Do no harm" is the mantra that health care providers live by. Doctors, nurses and laboratory professionals alike enter into the business … [Read more...]
PATIENT SAFETY
List of Top 10 Patient Safety Concerns Implicates Lab-Related Issues
May 4, 2016
Four of the top 10 patient safety concerns, compiled from reports of more than 1.2 million safety events, literature review and expert opinion, have relevance for laboratories and diagnostics. ECRI … [Read more...]
