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Risk assessment, clear mitigation strategies are keys to avoiding IJ for ligature risk


February 1, 2018

Thorough risk assessments and clear plans to mitigate danger to patients will be critical to satisfying CMS concerns about ligature risk, say experts.

CMS issued a long-awaited survey-and-certification memo on December 8 to help guide its regional and state surveyors as the agency ramps up pressure on hospitals to minimize the chances patients identified as at-risk for self-harm have to injure themselves while in a behavioral health unit or psychiatric hospital.

The memo, S&C 18-06-Hospitals, “Clarification of Ligature Risk Policy,” identified ligature risk as “anything which could be used to attach a cord, rope, or other material for the purpose of hanging or strangulation. Ligature points include shower rails, coat hooks, pipes, and radiators, bedsteads, window and door frames, ceiling fittings, handles, hinges and closures.”

Accreditation consultants and other experts say the memo was helpful in identifying CMS concerns, especially when combined with a similar policy statement outlined by The Joint Commission (TJC) at its annual Executive Briefings in the fall and in its November Perspectives newsletter that may offer more compliance instruction.

Still, there are areas that could use more clarity, say the experts. While CMS memo uses both the phrase “ligature resistant” and “ligature free,” TJC officials emphasized they were switching to the use of “ligature resistant” and encouraging others to do the same, even requesting that the Facilities Guideline Institute update its language in its Design Guide for the Built Environment of Behavioral Health Facilities, which TJC recommends for hospitals (ECL 10/9/17).

The memo also talks at length about how hospitals may go about asking for more time to deal with renovations or repairs to correct ligature risk deficiencies, but also states that “unmitigated” risks will result in an immediate jeopardy finding, which can halt a hospital’s ability to bill Medicare if upheld.

In the memo, CMS promises even more guidance as it rewrites its interpretive guidelines for surveyors in the State Operations Manual, Appendix A (SOMA), which it expects to take about six months.

“I think a big part of the struggle from a regulatory perspective is that it is pretty much impossible to provide a risk-free environment (hence the switch from ligature-free to ligature-resistant in the TJC guidance) and it is very rarely a ‘one size fits all’ situation,” notes Steven A. MacArthur, senior consultant with The Greeley Company in Danvers, Mass., and the author of the blog “Mac’s Safety Space.”

Dealing with ligature problems begins with a thorough risk assessment, which hospitals struggle with, says MacArthur.

In reading the CMS memo and its accompanying interim Interpretive Guidelines, MacArthur and other experts focused in general on three areas: risk assessment, the possibility of a time extension to deal with problems and the mitigating strategies that would allow that time.

Risk assessment
The interim guidelines state that CMS expects an environmental assessment related to ligature risk, just as it expects patients to be assessed for self-harm or suicide risk.

“Environmental risk assessment strategies may not be the same in all hospitals or hospital units. The hospital must implement environmental risk assessment strategies appropriate to the specific care environment and patient population. That does not mean that a unit which does not typically care for patients with psychiatric conditions is not expected to conduct environmental risk assessments. It means that the risk assessment must be appropriate to the unit and should consider the possibility that the unit may sometimes care for patients at risk for harm to self or others,” state the interim guidelines.

“It is heartening to see the invocation of the risk assessment process as an important piece of the puzzle, particularly in the immediate future” observes MacArthur. But he noted that CMS is not pushing a particular assessment tool, probably to avoid potential liability or criticism in the future “if something they specified didn’t quite result in a sufficiently risk-reduced environment.”

The interim guidelines do point to what CMS expects an assessment to include. “While CMS does not require the use of an Environmental Risk Assessment Tool (e.g., the Veteran’s Administration Environmental Risk Assessment Tool), the use of such tools may be used as a way for the hospital to assess for safety risks in all patient care environments in order to minimize environmental risks and to document the assessment findings,” state the interim guidelines under Condition of Participation (CoP) Tag A-0144 on a patient’s right to care in a safe setting.

An environmental risk assessment tool, state the interim guidelines, “may include prompts for staff to assess items such as, but not limited to:

  • Ligature risks include but are not limited to, hand rails, door knobs, door hinges, shower cur-tains, exposed plumbing/pipes, soap and paper towel dispensers on walls, power cords on med-ical equipment or call bell cords, and light fixtures or projections from ceilings, etc.
  • Unattended items such as utility or housekeeping carts that contain hazardous items (mops, brooms, cleaning agents, hand sanitizer, etc.)
  • Unsafe items brought to patients by visitors in locked psychiatric units of hospitals and psychiatric hospitals.
  • Windows that can be opened or broken
  • Unprotected lighting fixtures
  • Inadequate staffing levels to provide appropriate patient observation and monitoring.

Do not rush the assessment
Conducting the risk assessment will not be easy or quick. It must be thorough, says MacArthur and others.

“Basically, they need to list everything in the room/space/etc. -- and I do mean everything, including walls, ceilings, floors, components of beds and so on -- and assess for the risk of each,” warns MacArthur.

“If a surveyor asks something like ‘Hey, what about the door frame -- that’s a very solid surface upon which someone could bash their head,’ and you haven’t included the door frame in the risk assessment with subsequent mitigation, then you’re looking at an IJ,” he says.

“We have been working on a risk assessment for our inpatient Behavioral Health Unit for a few years now,” says Tammy Owens, an accreditation officer with a hospital system in Texas. “On a regular basis, we do a walk-through of the whole unit and prioritize what would be the most important items to replace.”

It is important that a behavioral health expert from your hospital’s BH unit or from within your health system is part of that walk through, she notes. They are the subject experts and having their involvement is “an eye-opening experience. They identify ligature points that I wouldn’t have ever thought of,” she says.

“The latest one that I didn’t think of, for example, is a door handle that is sloped downward. I’m thinking it is a good handle since someone couldn’t hang themselves on it, but our behavioral health leaders stated that they have heard of patients tying a sheet to that handle and looping it over the door,” giving the patient a ligature point,” says Owens.

Carry a thin cord or cloth with you as you evaluate the inpatient space, suggests experts from Patton Healthcare Consulting (PHC) in Naperville, Ill. Use the cord or cloth to “test the safety of your fixtures, in particular your doors. Using this technique, we have identified doors and hinges that hospitals purchased in the belief that they were safer, but we find they still permit an easy tie or pinch point,” according to a recent PHC newsletter.

Mitigating strategies
The CMS memo hints, although does not clearly state, that a hospital may be able to avoid a ruling of immediate jeopardy if it can show it is actively removing the risk physically or otherwise mitigating the danger through what it terms “interim patient safety measures.”

The memo does state that “the presence of unmitigated ligature risks in a psychiatric hospital or psychiatric unit of a hospital is an immediate jeopardy situation.”

That mitigation strategies that will be considered acceptable are “perhaps clearer and easier in the CMS memo than in the earlier communication from TJC,” observes Kurt Patton, who founded PHC after a stint as TJC’s executive director of accreditation services.

Among strategies mentioned in the memo is “the concept of ‘continuous observation’ not just 1:1” observation, as has been emphasized in the past by TJC and others as a way of keeping at-risk patients safe. “It appears permissible to have one staff person observing two patients using continuous observation in a two-bedded room,” whereas TJC so far has only discussed one-on-one observation, says Patton.

“Another interim safety measure may include locking rooms in which ligature risks have been identified to prevent patient access,” notes the CMS interim guidelines.

CMS also includes removal of sharp objects from the room or area or removal of equipment that can be used as a weapon, notes Ernest E. Allen, a former TJC surveyor and now a patient safety account executive with The Doctors Company in Columbus, Ohio.

Locking off rooms or areas where a ligature or other risk has been identified or instituting one-on-one observation are not only good, but could be the only ones likely to pass survey, notes MacArthur. “Any strategy that removes the risk completely -- as in not using the room, for example -- then that probably buys you some time,” he adds.

He does warn that one-on-one observation “is rarely a perfect solution, just because of the human element. But if that’s the way you choose to go, there must be absolute certainty that it can be implemented -- not enough staff will not get you out of hot water if it should be identified during a survey.”

Be prepared -- and prepare your leadership -- to create a budget to pay for those mitigating strategies. Owens noted that her health system’s BH units sometimes also take medical patients. “They definitely require some specialized care items such as specialized ligature-resistant medical beds, which were very costly.”

Time extensions
Although warning that regulations call for any deficiencies to be corrected within 60 days, the CMS memo also acknowledges that can be problematic in BH areas because corrections may involve time- and budget-consuming repairs or renovations.

The memo lays out when and how a hospital may be granted more time, leaving it for now to the judgment of the surveyor from CMS or an accrediting organization who identifies the deficiency.

The memo also specifies that the survey organization must keep track of how the hospital is progressing in repairing or removing the risk, with monthly reviews and a list of information that CMS will require during that monthly check.

To facilitate that review, “CMS has included a two-page form for requesting additional time to comply with recommendations, which includes mitigation plans the hospital will implement until the deficiencies are corrected,” notes Allen. The form is an attachment to the memo.

The memo also says it is entirely up to CMS to grant the time extension sought by the hospital, whether it is on the recommendation of the CMS state or regional surveyor or the accrediting organization.

“If the hospital’s request is approved, the hospital must provide updates every 30 days to CMS until the item is corrected.  Documentation is also required with the update, such as invoices, receipts, communications with vendors, etc.,” notes Allen. “CMS now says they will respond within 10 days of a request for an extension, which is much quicker than they take for Life Safety extension requests.”

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

Patton Healthcare Consulting, November newsletter: https://pattonhc.com/patton-healthcare-consulting-newsletters/november-2017-phc-newsletter/

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