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CMS memo to clarify ligature risk policy sets stage for more guidance later


February 1, 2018

Assess all patient care areas in behavioral health units and psychiatric hospitals for possible ligature points and be prepared to do what it takes to correct problems or have an interim safety measure in place to avoid a finding of immediate jeopardy (IJ) by CMS.

Hospitals that can remove the problem causing the IJ or otherwise implement interim patient safety measures that allay the problem may be able to negotiate more than the 60-day deadline for a permanent solution before losing your status to bill Medicare, according to a new Survey-and-Certification (S&C) memo from CMS on ligature risk.

However, whether a delay is granted is being left to the judgment of the surveyor and CMS is setting significant documentation and other requirements for the time waiver to be approved.

The memo, published online December 8 and effective immediately, outlined for state and regional CMS surveyors the concerns of the national office that hospitals were not doing enough to protect vulnerable behavioral health (BH) patients from risk of suicide or other self harm.

While the S&C 18-06-Hospitals memo carries the title “Clarification of Ligature Risk Policy,” consultants and accreditation officers were quick to note contradictions. CMS itself said that the guidelines presented were interim while it “is in the process of drafting comprehensive ligature risk interpretive guidance to provide direction and clarity for Regional offices (RO), State Survey Agencies (SAs), and accrediting organizations (AOs).”

That more comprehensive guidance is expected to take at least six months, CMS noted. The memo comes on the heels of guidance on extensive ligature risk expectations from The Joint Commission (TJC) at its fall Executive Briefings sessions and in the November issue of Perspectives.

In the meantime, the best action is to err on the side of the most stringent expectations, including being prepared to make substantive physical or operational changes within the 60-day window in case the surveyor on site decides the hospital is not doing enough to solve the deficiency, say experts.

That means warning your leadership that resources are necessary to either solve problems now, as soon as you identify them, or face an even bigger bill if a CMS surveyor finds immediate jeopardy.

Tammy Owens, an accreditation officer with a hospital system in Texas, says she has been working with her leadership for months to get buy-in on changes needed on their behavioral health units, at least one of which is housed in one of the older buildings within the health system.

Concerns about ligature risks have been expressed all year and the new S&C memo “obviously showed that CMS was very serious about decreasing these risks. I think it’s important to share information like this with leadership with a sense of urgency so they aren’t blindsided and they remain informed of issues that have been identified in the organization,” says Owens.

After taking this most recent memo to leadership, Owens noted that officials were quick to agree to more resources, in part because they were already familiar with the concerns, what was at stake for the facility and why the request was likely to happen soon.

What does the memo say?

“The good news is the memo has a fair degree of consistency with what TJC has already published, and a process for those organizations that cannot renovate in 60 days or less has been developed. That said, there are some peculiarities to this memo,” observes Kurt Patton, a former TJC executive director of accreditation services and founder of Patton Healthcare Consulting, now based in Naperville, Ill.

The CMS memo notes that under Condition of Participation §482.13(c)(2) on Patient Rights, patients have the right to care in a safe setting, and that ligature risk in the physical environment would compromise patient safety — and particularly so for “a patient with suicidal ideation.”

The guidance primarily targets patient care areas in psychiatric hospitals and BH units, but also notes that BH patients in other settings must also be protected.

“The focus of this memo and the forthcoming guidance is care delivered in psychiatric units/hospitals and does not apply to other healthcare settings such as acute care hospitals. Psychiatric patients requiring medical care in a non-psychiatric setting (medical inpatient units, ED, ICU, etc.) must be protected when demonstrating suicidal ideation,” states the memo. “The protection would be that of utilizing safety measures such as 1:1 monitoring with continuous visual observation, removal of sharp objects from the room/area, or removal of equipment that can be used as a weapon.”

However, while the title points only to ligature risk, the memo also notes that safety risks in a psychiatric setting can include “breakable windows; access to medications; access to harmful medications; accessible light fixtures; non-tamper proof screws; etc.”

The memo states that ligature points can include such items as “shower rails, coat hooks, pipes, and radiators, bedsteads, window and door frames, ceiling fittings, handles, hinges and closures,” but also notes that more “direction, clarity and guidance” is needed. As that guidance is being drafted over the next few months, it leaves the specifics and severity of risk to surveyors.

“In the interim, the SAs and AOs may use their judgment as to the identification of ligature and safety risk deficiencies, the level of severity for those deficiencies, as well as the approval of the facility’s corrective action and mitigation plans to remedy the identified deficiencies in collaboration with CMS.”

CMS also emphasizes that under Medicare regulations, deficiencies identified by surveyors that must be addressed in a formal Plan of Correction (PoC) must be corrected within “60 days from receipt of the deficiency report.”

Time extensions possible

But it also acknowledges that the “ability of facilities to comply with the limited number of days allotted for the correction of ligature risks has proven to be burdensome based on a number of variables, such as the severity and scope of the deficiencies, the need to obtain governing body approval, capital budget funding requirements, engage in competitive bidding, availability of the required materials, time for completion of repairs, and access to the unit/hospital areas.”

It lays out a procedure that allows for ligature risks “that 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,” might be corrected within an “allotted number of days accorded by the CMS RO, SA or AO.”

And “in cases where the SA or AO determine that it is not reasonable to expect compliance within the specified number of days, SA or AO may recommend additional time be granted by CMS in accordance with the regulations,” according to the memo. The additional time can only be granted by CMS, however.

And the hospital’s request for a time extension must include:

  • The hospital’s plan of correction, or PoC, as accepted by CMS.
  • A mitigation plan and an evaluation of the effectiveness of that mitigation plan.
  • A rationale for why it is not reasonable to meet the defined correction timeframe.
  • And regular updates on the status of the PoC.

In an appendix to the memo with what appears to be at least the beginning of draft interpretive guidelines to be used by CMS surveyors, the time extension requirements are further outlined to include, among other things, electronic progress reports on a monthly basis that should contain but “are not limited to, copies of invoices, receipts, communications with vendors, etc. detailing ongoing progress correcting the ligature risks and other safety deficiencies. The facility is also required to provide ongoing electronic routine status updates on the effectiveness of mitigation strategies utilizing outcome and process measures to demonstrate the effectiveness of the plan.”

Under CoP Tag A-0144, the Patient Rights requirement for care in a safe setting, the interim interpretive guidelines reiterate the language in the memo that ligature risks that “do not pose an immediate jeopardy situation or no longer pose an immediate jeopardy situation” because the threat has been removed or mitigated by interim patient safety measures can be part of the plan of correction and may be eligible for a time extension, as outlined.

However, further into the appendix, under CoP Tag A-0701, requiring hospitals to maintain the physical plant and overall hospital environment “in such a manner that the safety and well-being of patients are assured,” CMS notes a variety of possible safety risks for surveyors to look for, including ligature points.

“The presence of unmitigated ligature risks in a psychiatric hospital or psychiatric unit of a hospital is an immediate jeopardy situation. Additionally, this also includes any location where patients at risk of suicide are identified. Ligature risk findings must be referred to the health and safety surveyors for further evaluation and possible citation under Patients’ Rights.”

Mitigated vs. unmitigated risk

The difference between whether a hospital has extended time to implement a plan of correction and being under immediate jeopardy with a threat to accreditation may depend on the surveyor.

“At least at the moment, it appears that the key word is ‘mitigated,’ and the devil will live in the interpretation of the surveyor as to whether or not the mitigation strategy provides the same level of safety as the permanent resolution of the issue/condition,” notes Steven A. MacArthur, senior consultant with The Greeley Company in Danvers, Mass., and the author of the blog “Mac’s Safety Space.”

“That said, at this point (particularly in behavioral health facilities), I’m not certain how many unmitigated ligature risks are actually out there, but I can say that folks are not as all-encompassing in their risk assessments as would serve them well during survey,” says MacArthur.

Patton says that in his view, the CMS memo means if CMS sees an unmitigated risk, the surveyor will have to score it as an immediate jeopardy and the hospital will have to clear that IJ ruling before it can implement a renovation plan.

The CMS memo did offer some clarity on such things as how to mitigate a ligature and other self-harm risks.

“The good news is that CMS now allows one-on-one staffing for ligature risks in the ED [emergency department] (or other units outside of the behavioral health unit) in helping to protect the patient who is ‘demonstrating suicidal ideation or harm to others.’ CMS also includes removal of sharp objects from the room/area or removal of equipment that can be used as a weapon,” observes Ernest E. Allen, a former TJC surveyor and now a patient safety account executive with The Doctors Company in Columbus, Ohio.

Still, after reading the CMS memo, Allen says, “I felt the Joint Commission article released in November offered more advice on compliance.”

When faced with contradictions, Owens advises, “I feel it’s safer and more prudent to make sure we try to meet the strictest regulations as much as possible and make educated decisions as to what each AHJ [authority having jurisdiction] would look for during survey.”


CMS S&C 18-06-Hospitals: https://tinyurl.com/CMS-ligature-risk-memo-2017

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