Every inspection cycle we receive our checklists from the regulatory organizations and that is usually when the latent lawyer in me breaks out like the Hulk and I start interpreting the meaning of every word contained within the document. CAP has said on multiple occasions that some of the checklist items are open to interpretation and that there can be several ways to satisfy them. CLIA has their 6 elements of competency and when I first read them my eyes started to turn green and my clothes started to get a little snug. The element that I think is open to the most discussion is the first: “Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing.” Some of my colleagues have interpreted this as once a year directly observing a technologist/technician perform each test and then signing them off. When I read this element I can’t help but think that once a year is not enough to verify that an employee is correctly performing each test. The question I always ask is how do we know that an employee does it correctly when we are watching but then does it a different way when we aren’t?
I am a very hands off leader. The reason I can do this is because when I train a new employee it is rigorous and I make sure that they can handle pretty much anything that comes their way. When I read that first CLIA element I feel as if they want us to babysit our employees. I understand the importance of direct observation but where is the line drawn that says so much observation is enough? If you ask me once a year is not enough; however, the more we observe the less time we have to do our countless other tasks as supervisors/managers.
When I thought about it, I came up with a couple methods or ways to “directly observe” my employees. The first obviously is to stand behind them and watch them perform a test. Then the question of how do we observe the off shifts without actually being there? We all have smart phones with cameras so could employees could set up their phones to record a procedure and then we could watch it back later. In blood bank I can have each employee save their gel cards so that I can read them at a later time and make sure the volumes in each well look ok. That would qualify as direct observation of their results and process since if the volumes are incorrect I would be able to tell. As supervisors we are also called to consult with other technologist/technicians frequently. Troubleshooting with your employees usually involves something test related and that to me would count as direct observation as well. Finally, we have students almost year round and our employees usually take on the role of teacher when they are in that spot for the day. When I observe them teaching the students how to perform tests this is a great way to confirm that the employee is competent.
My favorite way to observe is when my employees don’t know I’m watching. I have an office that is not directly in the blood bank so I have to wander in and out fairly often. Sometimes I will sit down or file papers all the while observing my employees and their technique and processes. There are many ways to “directly observe” and using all of them ensures that you are meeting the guidelines enforced by CMS. When inspection time comes you can show the signature that says you directly observed but also have a list of answers when they ask how you did it. When I need some practice I grab my binoculars and do a little bird watching.
–Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.