Hospital lawyers, whether in-house or outside counsel, have oversight over many facets of the hospital’s operations. One department they may not be focused on, but should be, is the hospital’s laboratory. In an article published this week in BNA’s Health Law Reporter, my colleague Hope Foster, Almeta Cooper of Morehouse School of Medicine, and I address compliance time bombs that may be lurking in hospital laboratories.
The article gives an overview of how hospital laboratories are regulated by state and federal law and by accrediting organizations. We address how the stringent penalties for noncompliance can have an enormous impact on a hospital’s operations, as laboratory testing is a key component of patient care. We then focus on one key compliance issue: ensuring that each hospital laboratory is appropriately performing proficiency testing. As we indicate in the article, even after CMS relaxed some of the most draconian regulations around the penalties for violations related to proficiency testing in 2014, proficiency testing remains an area in which there is no margin for error in a hospital laboratory.