I know a lot of you have heard already, but for those of you who haven’t, last week CMS ruled to amend CLIA regulations that will now allow laboratories to release test results directly to patients. Once you pick your jaw back up off the floor your mind will start processing a mile a minute what this means for individual laboratories. If you are a supervisor/manager such as me your mind is going exponentially faster thinking of all the ways that this now makes your life more difficult.
Right off the bat as a supervisor/manager you should be thinking about producing an SOP (standard operating procedure) that details how you will handle requests and what you are and are not responsible for when it comes to providing information to patients. You are going to need detailed information on how you will properly identify the patient, patient’s personal representative; or my personal favorite, a person designated by the patient. I can hear the phone ringing now.
“Laboratory this is Matt, How can I help you?”
“Yes, Hello, My name is Lenny Lipase and my neighbor Pete Potassium wanted me to call in to your laboratory and get some of his lab results.”
There is most definitely going to be some individual interpretation of this new amendment and each laboratory is going to have to determine how it wants to address requests. No matter which direction you go a solid policy/procedure for handling these new requests will be your best friend. When you receive complaints, and you know they will come, you will have something to fall back on that states a definite policy/procedure and that meets the new standard that has been set forth by CMS.
So let us address the 800lb. gorilla in the room. You have started taking requests for results and a patient comes to your lab, picks up the results, opens them, and then says, “Why is my glucose so high? Does eating a candy bar for breakfast affect this?” Your worst nightmare, right? A patient wanting counsel on results will be the biggest challenge for any laboratory and may have been a possible oversight by CMS on this ruling. One way to nip this right off the bat is to send hard copies of results in the mail. This assures that patients will not be wandering around your lab asking for counsel on their results. If you decide to be brave and let patients physically pick their results, I would either have a disclaimer page with every result handed/mailed out or written very clearly in your policy/procedure stating that patients only discuss their results with their physician. You must protect yourself from liability when it comes to discussing results with patients. I felt as though the previous ruling was a laboratory professional’s layer of protection against this. We could not directly give patients results so it forced them to speak with their physicians.
I have read that some laboratory professionals are happy with this saying that patients should take more of the responsibility of their own healthcare. I agree with this but I also have spoken to physicians who are not happy with this ruling because they want to go over results with their patients to properly explain what they mean. More than likely a physician will still have to release the results first before a patient can view them but if not you may have a panicked patient calling physician offices or even worse 911. This may seem extreme but you don’t know how patients will react seeing results they do not know anything about. We will now be another controller of patient information that has been deregulated a bit. It is for medical use only of course but how comfortable will you feel being a result dispensary?
–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.