COMPLIANCE

Where’s your lab safety manual?

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio Laboratory leadership should be committed to providing a safe working environment, and they should believe their employees have a right to … [Read more...]

SAFETY

Diagnostic danger in the lab: Time to reform how we process orders

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

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

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

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

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

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

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

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

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...]


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