If you are among those frustrated by having to implement costly, time-consuming, and seemingly ever-changing requirements on ligature risk and suicide prevention, now is your chance to speak up.

CMS is asking for public comment on revisions to the sections of Medicare’s State Operations Manual, Appendix A (SOMA), for state hospital surveyors on determining a facility’s precautions against patient self-harm as well as a section of the manual describing the process of handling facility requests for a time extension to take corrective actions.

The requirements are intended to apply only to behavioral health (BH) or acute care facilities with locked psychiatric units, including, says the guidance, “locked emergency department psychiatric units.”

Often, corrective actions include extensive renovations that take time and require capital budget requests that cannot be done within the normal 60 days CMS mandates for correcting deficiencies related to the Conditions of Participation (CoP).

According to a recent report commissioned by the National Association for Behavioral Healthcare (NABH), The High Cost of Compliance, the average cost to implement ligature risk requirements for a 100-bed psychiatric hospital was $3,462 a day. Physical renovations and equipment purchases, meanwhile, were running an average of “more than $12,700 per psychiatric bed.”

Some new sections

While the revisions overall appear to tweak or attempt to clarify earlier interim guidance on ligature risk and patient self-harm released in December 2017, there are new sections that discuss such things as locked versus unlocked psychiatric units, and staff education and training on screening for patient risk of self-harm.

In a bit of good news for some hospitals, CMS says—just as The Joint Commission (TJC) announced two years ago at its Executive Briefing in Chicago—that toilet seats pose a minimal ligature risk and “surveyors are encouraged to review the patient care environment in its entirety (to include a thorough review of any risk assessments completed) and not consider this one item as non-compliance in the absence of other factors.”

The revisions also note, much as TJC has, that observation of at-risk patients who need 1:1 supervision during “toileting, bathing or other acts of personal hygiene” may be restricted by individual state laws. “Hospital staff as well as surveyors when assessing compliance with these requirements, must be aware of their State requirements and potential impact on the provision of care to patients in need of 1:1 visual observation,” say the proposed revisions.

The public has until June 17 to submit comments or questions to CMS at HospitalSCG@cms.hhs.gov, according to the Quality, Safety & Oversight Group memo, DRAFT-QSO-19-12-Hospitals, posted on CMS’ online site for policy memos in mid-April. CMS promises to review the comments before finalizing the revisions.

Comment while you can

Take this chance now to comment, advises Jennifer Cowel, RN, MHSA, CEO of Patton Healthcare Consulting, who is a former director of service operations at TJC and served many years as a nurse surveyor.

“We see hospital staff moved to tears when they are faced with hundreds of thousands of dollars’ worth of renovations in their BH units. Some leaders fear that the increased burden by these regulations may tip the scale on decisions about keeping a behavioral health unit open or closing it due to the financial burden of the renovations,” says Cowel.

The revisions are similar to guidance that TJC has released in the last 18 months, notes Kurt Patton, MS, RPH, who founded Patton Healthcare after serving as TJC’s executive director of accreditation services. “Having guidance that indicates that TJC and CMS are somewhat on the same wavelength is a good thing.”

However, there are some differences, note Cowel and Patton.

“The memo spells out more risk points than are spelled out in the TJC literature. The memo focuses on ligature, but when CMS outlines the risks that should be assessed and eliminated, they describe items like tamper-resistant screws,” points out Cowel.

“Issues like screws are not a ligature issue, and they do not come to the front of mind when staff assess the safety of their environment, but they are equally as important as the more obvious ligature issues. I would suggest that a hospital review and pull out all the examples provided in the memo and then re-review their space for those items,” advises Cowel.

“If necessary, update your risk assessment and date it. We find hospitals that have gone a long way to eliminate ligature points but still have risk points for self-harm or violence against others,” she notes.

Changes to requests for extension

Also review the section on requesting extensions for correcting deficiencies. “One minor change is TJC has written about this subject calling it an LFER, for ligature facility extension request,” says Patton, “and CMS has changed the acronym to LRER, for ligature risk extension request.” 

“From an operational planning perspective, hospitals need to think carefully about applying for this LRER, if they are cited by TJC for ligature risks,” warns Patton. TJC’s evidence of standards compliance (ESC) is normally due in 60 days, but the Medicare follow-up for condition-level findings is in 45 days. That means your timetable to decide on changes is much shorter, he says. And remember that such requests must go to the accrediting organization, which sends it to CMS for approval before that decision is communicated back to the facility.

“This just means you can’t delay concluding you will need an extension, as the LRER must go through the AO, then be to CMS before the 60 days is up,” says Patton.

Other changes are also significant, says Patton.

“I did note training requirements are very detailed on page 11, including training on the screening and assessment required, training on mitigation strategies, and training is required for staff not full time on the unit, but periodic, limited-duration assignments like dietary, security, maintenance, housekeeping, and others,” he says.

More importantly, CMS is focusing on more than just ligature risk.

“The most significant difference for me is that TJC has focused like a laser on suicide risk,” says Patton. “CMS takes a broader view, similar to what TJC used to do looking at suicide risk and violence risk. From an environmental perspective, this opens up criticism of light chairs and other furniture that can be used as a weapon.”

“In addition, page 10 of the draft says patients must be screened for risk of suicide or homicidal ideation, including intent or demonstrating violent or aggressive behaviors. This is something that hospitals do today somewhat informally as part of the admission assessment,” notes Patton. “Unfortunately, data about past experiences with this patient and history of violent behaviors and structured assessment tools are usually not available.” 

“The remaining point of major confusion to state surveyors is what environmental hazards are condition level and what hazards are immediate jeopardy level. Based on review of recent CMS reports, this does not seem to have any structure or consistency, nor does it appear that it is considering active LFERs previously approved by TJC and CMS,” observes Patton. 

The NABH also discussed surveyor inconsistency and offered up several recommendations. The organization, which changed its name last year from the National Association of Psychiatric Health Systems, has previously partnered with TJC on other mental health initiatives.

[Sidebar]

Ligature risk: NABH proposals for reform

The following is quoted from the National Association for Behavioral Healthcare, from page 17 of its recent report, The High Cost of Compliance.

“CMS should issue its promised guidance as soon as possible to minimize wasteful renovations. In that guidance, CMS should endeavor to standardize survey practices, both across surveying bodies and among individual surveyors. We recommend that CMS take the following steps:

Require surveyors to apply a more evidence-based approach to ligature-risk review. If the facility’s current equipment, design, or practice is widely used and has not been linked to any known patient self-harm attempts the facility’s approach should be presumed compliant; surveyors should be required to offer an empirical basis for requiring a modification. Absent a compelling empirical basis for demanding immediate, large-scale changes, surveyors should be limited to, if anything, recommending modifications.

Clarify that an inpatient psychiatric facility need not design highly ligature-resistant physical spaces in areas that are under constant supervision, such as nursing stations and cafeterias, unless there is a special need for such design.

Identify areas of design or categories of equipment that carry particularly acute ligature risk, thereby putting inpatient psychiatric facilities on notice that those areas are likely to be closely scrutinized during surveys. If CMS later identifies additional areas of acute concern, the agency should issue a public notice so providers have a reasonable opportunity to implement any necessary changes before their next review. This policy would allow facilities to plan ahead and budget for the changes. Emergency renovations undermine efficiencies, heighten the risk that clinicians will need to refocus attention away from care delivery, and can create financial hardship for the facility.

Minimize the risk of redundant renovations. After a surveyor accepts a particular design feature as ligature-resistant when approving a corrective action plan or during a validation survey, future surveyors should not be permitted to issue citations based on that approved feature for a prescribed period (e.g., three years), absent special circumstances.”