Since I’ve been left to figure out this quality thing for wound care pretty much on my own, I’ve had a lot of ups and downs. One of my goals (but not the only one) is to develop quality measures to help practitioners and patients survive the increasing pressure of Medicare audits. After months of targeted probes against the durable medical equipment companies (DMEs) directed at the use of collagen and alginate dressings,  I developed a quality measure focused on ensuring that orders for surgical dressings from a DME were appropriate to the needs of the wound and met CMS requirements. Unfortunately, CMS isn’t supportive of that measure because it’s not an “outcome” measure. Well, if by “outcome” you mean wound healing, we already have some wound healing measures. I was specifically trying to improve the surgical dressing DME order process since CMS has been running targeted probes directed at this PROCESS! I’m trying to keep patients from getting bills for thousands of dollars because payment for their DME order was retroactively denied for a stupid documentation reason (e.g. the number of units wasn’t on the order). But, it turns out that one part of CMS cares about process and the other part doesn’t.
If CMS thinks that process measures are so bad, why do we have to document a “time out” when it’s irrelevant? Last year my hospital got surveyed by the Joint Commission and our hospital-based outpatient wound center was visited by the surveyor. The JCAHO surveyor cited me for not including in my debridement procedure note that a “time out” was called prior to the start of the procedure. A “time out” is used in the inpatient operating room because a procedure (perhaps a major surgical procedure) is scheduled in advance and an inpatient is brought to a procedure area who is probably not known to any staff members present and may have been sedated. It is therefore necessary for the patient (who may be unable to identify themselves) to be properly identified before the procedure can be initiated.
What happens in the OUTPATIENT clinic is the opposite. A patient WHO WE IDENTIFIED AT THE FRONT DESK BY 2 METHODS INCLUDING A FACE PHOTO, is brought into an exam room where they are again identified by two methods including a facial photo. Their electronic chart is opened in the room, and I document in the chart at the point of care. In the course of the patient visit, I decide that a debridement is appropriate. I have been in the room with the patient this entire time. The question is not, “Who is the patient?” but “What procedure are we going to do?” There is absolutely no reason to document a “time out,” because, due to the process (dirty word) that we follow in the OUTPATIENT clinic, the identity of the patient is never in question.  The decision to perform a procedure happens AFTER we have identified the patient.
That’s why, in the 20 years I have worked in the outpatient clinic setting, I have never officially performed a “time out” the way it is done in the operating room. The purpose of the “time out” is to identify the patient and do the right procedure on the right patient. We have a different process to accomplish that in the outpatient setting simply due to the nature of our patient flow. If I were to suddenly (scalpel in hand) look around the room and say, “Can we confirm that this is the same patient I have been talking for the past 10 minutes and on whom I decided to perform a debridement only one minute ago?”, everyone (including the patient) would question my sanity. However, because the JCAHO cited me for not including “time out” language in a debridement procedure note, I am now required to include that language, EVEN THOUGH IT IS NOT APPLICABLE TO OUR SETTING AND EVEN THOUGH WE DO NOT USE A TIME OUT TO CONFIRM PATIENT IDENTITY IN THIS SETTING (we use 2-factor patient ID at check-in and in the room). By failing to understand our site of care, the JCAHO surveyor turned a genuine safety procedure into an annoying paper compliance game. This cheapens the safety culture. (This is also an excellent example of why inpatient JCAHO standards cannot be applied to outpatient clinics, which is a story for another day.)
“Time out” is a valid process in the operating room. There are processes which DO matter for safety, appropriate use and payment policy. That IS my point. If CMS doesn’t think that having practitioners follow  CMS documentation policies (for ordering cellular products, hyperbaric oxygen therapy, or surgical dressings, for example) are quality issues, then we need to spread that word among the auditors. There are a lot of hospitals and physicians paying money back to CMS over issues that can best be described as process issues.
I have been told by the JACHO that I have to include a statement in my procedure note saying that I performed  a “time out” regardless of whether it is necessary or relevant AND that CMS doesn’t believe in processes. (If CMS wants to follow outcomes instead of processes, perhaps they can follow the number of wrong patients or wrong body parts operated.) I’ve been told that outcome is all that matters in quality measure development BUT clinicians will have to pay back money to CMS if they don’t follow the process (e.g. wait 4 weeks to start HBOT for diabetic foot ulcers). It’s really hard for a simple girl to square these viewpoints. Can’t we agree that there are some processes that MATTER and make really good targets for quality measures? Why is that so freaking hard?

Caroline Fife, M.D.

Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos