Mac's Safety Space: Shoes are dropping—Effective management of ligature risks
Pretty much since 2017, I have been wishing, hoping, etc. for the ligature resistance pendulum to find itself in something close to a middle ground. The pendulum will always sway a bit, but I’m thinking that the swings will be somewhat less acute than when we started this journey and move from the identification of environmental “deficiencies” relating to ligature and other harm risks to the effective clinical management of at-risk patients in whatever environments they might find themselves.
Back in July, CMS made some modifications to the State Operations Manual (SOM). I recognize that there has been a delay in my discussion of the changes. While I can (at times) be a bit irreverent in my prose style, I always try to be respectful of the process and its participants. Back when the update was issued, it was not clear how the changes were going to be administered by the various accreditation organizations (AO). My experience with survey results so far this year indicated that at least one AO was still very much focused on generating findings relating to ligature risks, so again, there really was a bit of mystery as to how it would play out. In the update to the SOM (the pertinent section begins on page 108 of the document) the language has been modified to characterize efforts to manage these at-risk patients to what “should” be done as opposed to what “must” be done. I think part of this is the recognition that the SOM has to act as a “one size fits all” proposition which, if not appropriately configured, can become a “one size fits none,” so the process has become one of risk management—identify the risk, abate the risk to the extent possible, mitigate the remaining risks, and so on. But in the section on the Correction of Environmental Risks (page 110 of the updated SOM document), we find the following passage:
“Cited noncompliance that include ligature risks, which do not pose an immediate jeopardy situation or no longer pose an immediate jeopardy situation because the immediate threat to patient health and safety has been removed by the hospital, or has been mitigated through the implementation of appropriate interim patient safety measures, should be corrected as soon as possible, but within the timeframe noted by the CMS Location, the SA, or the AO. Interim patient safety measures are expected to be implemented as part of an acceptable plan of correction to mitigate patient safety risks, as appropriate. Interim patient safety measures to mitigate identified ligature or safety risks may include, without limitation, continuous visual observation or 1:1 observation based on the type of identified risk.”
The interesting (at least to me) part of this is “should be corrected as soon as possible, but within the timeframe noted by the CMS Location, the SA, or the AO,” because it seems to be a bit of a diversion from the hardline 60-day turnaround for corrective action plans or invocation of the Ligature Risk Extension Request [LRER] process for conditions that cannot be resolved within the 60-day window. But it is not clearly the case—or at least it wasn’t until recently.
In a communication dated October 30, 2023, DNV acknowledged that it has been in conversation with CMS and seems to have been able to clarify several considerations, including the termination of the LRER process, based on the removal of the LRER language from the SOM with the further indication/interpretation that ligature risks no longer have to be corrected within 60 days (again, based on the removal of language from the SOM specifying that timeframe). DNV is awaiting final approval from CMS on the standards they have updated in their own requirements, but there seems to be little indication that this won’t happen. Which leaves the bigger question of how other AOs will react to this announcement. The one caveat in all this (and it’s really not that much of a caveat, to be honest) is that the physical environment risk assessment can no longer be a “one and done” proposition, but rather should be part of a strategy for managing environmental risks, including the education (at orientation and at least every two years thereafter) and involvement of staff in the identification and management of risks. As I think about it, I have been “banging the drum” for the effective integration of line staff into the management of the care environment for a very (very, very) long time; no program can be truly effective without that element. It looks like the regulations are reflecting that in a more formal way—finally, everyone gets invited to the party!
At any rate, I’m hoping that this represents the start of a shift to a “whole body” strategy for managing the risks associated with the behavioral health environment, and moving the focus from safety rounding to providing proactively safe patient care. More updates as they become available!
About the Author: Steve MacArthur is a safety consultant with Chartis Clinical Quality Solutions (formerly known as The Greeley Company) in Danvers, Mass. He brings more than 30 years of healthcare management and consulting experience to his work with hospitals, physician offices, and ambulatory care facilities across the country. He is the author of HCPro's Hospital Safety Director's Handbook and is contributing editor for Healthcare Safety Leader. Contact Steve at stevemacsafetyspace@gmail.com.