LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create

A couple of years ago, the lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory … [Read more...]


Medicare Reimbursement: How CMS Price Transparency Proposal Could Hurt Labs & Patient Relations

Last April, CMS issued a proposed rule to make Medicare rates more transparent. While designed to "empower patients and reduce administrative burden," the proposed changes would literally come at a … [Read more...]


AAB and NILA comments allege unlawful implementation of PAMA by CMS

The National Independent Laboratory Association (NILA) and the American Association of Bioanalysts (AAB) has formally commented to the Centers for Medicare and Medicaid Services (CMS) that the agency … [Read more...]


The Safety Interpretation

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio When hospitals were placed on OSHA's list of "high-risk" workplaces, no one had to ask why. OSHA adjusts that list based on the number of … [Read more...]


Case of the Month: Alabama Hospital Lab Settles Data Breach Class Action Suit

Class action lawsuits by patients victimized by data breaches have become increasingly common. And, more often than not, they prove unsuccessful. But a recent case involving Flowers Hospital in … [Read more...]


Cost Avoidance vs Cost Savings: What’s the Difference?

By Jennifer Dawson, MHA, DLM (ASCP)  bio As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to … [Read more...]


OIG Backs CMS on PAMA Market Rate Setting—and the Lab Industry Is None Too Pleased

CMS did it right and saved Medicare a boatload of money in the process, concludes a new OIG report examining the agency's work in carrying out its PAMA mandate of establishing market-based Medicare … [Read more...]


Cybersecurity: LabCorp Reports What Could Be a Major Data Breach

Cyberattacks and data breaches against health providers are a daily occurrence. But when the breach takes place at a firm as big and powerful as LabCorp and potentially affects the health records of … [Read more...]


Industry Report: Venture Capitalists Remain High on Healthcare

Healthcare startups remain highly attractive to venture capitalists drawing $10.6 billion in investments in the first half of 2018, the most of any industry sector other than internet companies and … [Read more...]


New Zika Blood Testing Guidance Effective Immediately

On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus. Summary After initially recommending universal nucleic acid testing of individual blood donation units, the … [Read more...]