Who Regulates Laboratory Developed Tests?

A laboratory developed test (LDT) is any test that has been developed by an individual laboratory, often using instruments and/or reagents that have not been approved by the FDA for use as/in an in vitro diagnostic test. For example, measuring pH using a pH meter and pH calibrators from a scientific supply company is an LDT. So is performing a spun hematocrit,  measuring acylcarnitines by tandem mass spectrometry, or performing newborn screening on dried blood spots. Even using an FDA-approved assay for samples or in a manner not specified by the manufacturer makes that assay an LDT. If you look around your lab, you may find that you’re performing an LDT without really thinking about it.

Who regulates these tests? The FDA regulates in vitro diagnostic testing, and LDTs fall under their purview. Until recently the FDA has used “enforcement discretion” and has essentially allowed CLIA regulations and CLIA oversight to ensure proper validation and monitoring of LDTs. CLIA regulation Subpart K, Section 493.1253 gives the specific parameters that must be properly validated in any non-FDA-approved assay. CLIA also regulates the proper usage and control of LDTs, just like any test performed in the laboratory. Is it necessary for LDTs to be regulated more highly than this?

In June of 2010 the FDA announced its intention of taking a more active role in LDT regulation in the future. They also held a public meeting to discuss their increased oversight. All laboratories which perform LDTs will do well to monitor developments in this newly intended enforcement of the FDA’s role, and keep abreast of changes coming out in the regulatory environment for these tests.

-Patti Jones

The Leadership Tightrope

When a physician describes what they do they will often say, “I practice medicine.” The reason for this is because each patient, even if they are in similar disease states, usually requires a somewhat unique treatment regimen.  The same can be said of leadership. We as leaders are constantly refining our leadership styles, and to a degree practicing what we learn and observe. Just like the patients, each employee we lead is slightly different and it is up to us to adjust to them and not vice-versa. I have been a leader for three short years but my leadership style has already gone through many changes and modifications as I learn and interact with my employees.

I have also been confronted with the challenge of the leader versus manager mentality. The natural tendency when an employee is struggling is to jump in and save the day. However, did you really help them? Perhaps the better approach is to discuss the problem with the employee, give them the tools they need, whether it be knowledge or physical items, and then observe the employee working out the problem themselves. This is the tightrope leaders walk, and it can sometimes feel like the most daunting of tasks.

I start this blog with the hopes of putting together the leadership puzzle by first analyzing the pieces and then taking a step back and viewing the big picture. I just finished my 6th year as a laboratory professional and celebrated by re-certifying with ASCP. I gain my experience through being a blood bank supervisor as well as a general supervisor in a mid-sized community hospital that is part of the larger conglomerate Cleveland Clinic. Working here has given me insight into the entire gambit of the lab as well as how we interact with the rest of the medical profession. I will often refer back to issues and how they relate “outside the four walls.” This is especially important to leadership and how we keep our employees engaged.

-Matthew Herasuta