Summerhill Elderliving Home & Care, DAB CR5412 (2019)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a per-instance civil money penalty of $10,000 against Petitioner, Summerhill Elderliving Home & Care, a skilled nursing facility.

I. Background

I held a hearing on May 28, 2019. I received into evidence exhibits from CMS that are identified as CMS Exhibit (Ex.) 1-CMS Ex. 13 and exhibits from Petitioner that are identified as P. Ex. 1-P. Ex. 26. I heard the cross-examination testimony of two CMS witnesses, Ms. Teresa Barber and Ms. Jane Olmstead.

The parties filed pre- and post-hearing briefs. In addressing arguments made by Petitioner I refer to “Petitioner’s post-hearing brief.”

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II. Issues, Findings of Fact and Conclusions of Law

1. A. Issues

The issues are whether Petitioner failed to comply substantially with Medicare participation requirements and whether a per-instance civil money penalty is a reasonable remedy.

2. B. Findings of Fact and Conclusions of Law

CMS alleges that Petitioner failed to comply substantially with four Medicare participation requirements. However, the lion’s share of CMS’s allegations address Petitioner’s alleged failure to comply with the requirements of 42 C.F.R. § 483.21(b)(2) and (b)(3), and 42 C.F.R. § 483.25(d)(1) and (2). Pursuant to 42 C.F.R. § 483.21(b)(2) and (b)(3), a skilled nursing facility must develop and implement a comprehensive care plan for each of its residents, developed by an interdisciplinary team that includes an attending physician. That plan must be periodically reviewed and revised after each periodic assessment of the resident’s condition. Services provided or arranged based on the plan of care must meet professional standards of quality and must be provided by qualified personnel.

Pursuant to 42 C.F.R. § 483.25(d)(1) and (2), a skilled nursing facility must ensure that its premises are as free as possible of accident hazards. Each resident of a facility must receive adequate supervision and assistance devices in order to prevent him or her from sustaining an accident.

CMS’s allegations of noncompliance with these regulations primarily focus on the care that Petitioner gave to a resident who is identified as Resident 98. CMS contends that, for several years, Petitioner provided the resident with a bed equipped with side rails without making a meaningful determination whether the resident’s evolving clinical condition reasonably justified the continued use of side rails. CMS contends also that these side rails created an accident hazard that Petitioner neither accounted for nor protected the resident against.

Petitioner initially admitted Resident 98 into its facility in July 2014. P. Ex. 12 at 2; CMS Ex. 8 at 1. On her admission, either the resident or her representative requested that her bed be equipped with side rails. P. Ex. 12 at 133.

Side rails are, as their name implies, railings that are attached to the sides of a bed. Typically, they project upwards several inches from the mattress and in some instances may be manually raised or lowered. They function both as a barrier and as an assistance device. They are a barrier in the sense that they restrain an individual from rolling in or

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out of a bed. They are an assistance device in the sense that someone in a bed equipped with side rails may use the rails to facilitate positioning.

But, side rails are a mixed blessing at best and a hazard at worst. Among other problems associated with the use of side rails is the possibility of entrapment: a resident, especially one with compromised mobility or suffering from dementia, may inadvertently become entrapped between the metal bars of a side rail or between a side rail and his or her bed’s mattress. There are numerous instances of such accidents occurring, and there is a lengthy history of cases in which facilities have been found at fault for failing adequately to plan the care of or supervise residents whose beds were equipped with side rails. Meadowwood Nursing Ctr., DAB No. 2541 (2013) (resident’s head entrapped by side rail); Laurelwood Care Ctr., DAB No. 2229 (2009) (resident died when arm and head caught in side rail); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004) (resident found reaching through unpadded side rail and hanging legs over rail); North Ridge Care Ctr., DAB No. 1857 (2002) (possible resident death caused by entrapment in side rail); Good Samaritan Ctr., DAB No. 1844 (2002) (resident’s head entrapped between side rail and mattress).

The risks inherent in the use of side rails impose a duty on a skilled nursing facility utilizing these devices to take all necessary measures to protect its residents. Side rails should not be used unless there is some measurable positive benefit to a resident that outweighs the risks and hazards associated with using such devices. In order to determine whether that is the case, a facility must carefully assess each of its residents for the suitability of side rails. It must do more than assess: the facility must translate its assessments of need and benefit into a plan of care that explains precisely how and under what circumstances side rails will be used in an individual resident’s case. That plan of care must also explain how a resident will be protected against the hazards and risks posed by the use of side rails. A facility must carefully supervise and protect any resident for whom side rails have been prescribed.

The evidence overwhelmingly supports my conclusion that Petitioner failed to discharge these duties in providing care to Resident 98. Petitioner failed similarly with respect to two other residents, Residents 68 and 202. Petitioner’s derelictions comprise failures to comply substantially with the requirements of 42 C.F.R. §§ 483.21(b)(2) and (b)(3), and 483.25(d)(1) and (2).

Beginning in July 2014, Petitioner continuously supplied Resident 98 with a bed equipped with side rails. Throughout a period of more than three and one-half years, Petitioner maintained these rails without adequately considering the implications of significant changes in the resident’s clinical condition. Petitioner continued to supply the resident with side rails even after the resident’s arm became entrapped in a side rail on March 2, 2018. CMS Ex. 8 at 6, 17; P. Ex. 12 at 151. Despite that incident, Petitioner failed to review the resident’s plan of care for use of side rails and failed to make any

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modifications in the care plan addressing the hazards that side rails posed to the resident. P. Ex. 12 at 599-611; 613.

These failures violated Petitioner’s own policy for development of resident care plans. That policy – which essentially duplicates regulatory requirements – directs the staff to revise each resident’s care plan periodically based on ongoing assessments of that resident’s clinical condition. CMS Ex. 7 at 12. But, despite that policy, Petitioner failed to address significant changes in the resident’s clinical condition that even some of its staff members recognized as raising questions as to whether continuing to supply side rails to Resident 98 was appropriate.

Resident 98’s condition deteriorated markedly after July 2014. She manifested worsening dementia. By January 2018 the resident no longer could communicate her needs to Petitioner’s nursing staff. P. Ex. 12 at 289. Resident 98 exhibited increasing muscle weakness. She remained legally blind. Her mobility deteriorated to the point where she became totally dependent on Petitioner’s staff for transfers and other activities. Id. at 16. She became bedbound.

These significant changes in the resident’s condition should have signaled to Petitioner’s staff that it should reexamine the appropriateness of continuing to supply Resident 98 with side rails. The changes in the resident’s condition and the issue of continued utility of side rails should have been discussed in the resident’s plans of care. However, although staff continued to complete side rail usage assessments for Resident 98 and to note the changes in the resident’s condition in these assessments, it failed utterly to ask and answer the basic question of whether continued use of side rails was appropriate for Resident 98. See P. Ex. 12 at 136-159. Rather, Petitioner continued to supply the resident with side rails as if nothing had changed. The facility failed to amend the resident’s plan of care to address possible diminished utility and increased risks associated with using side rails.

Notably, Petitioner’s staff failed to address findings in assessments of Resident 98 that strongly suggested that the staff should cease equipping the resident’s bed with side rails. In an assessment performed on August 2, 2016, the staff found that side rails were no longer appropriate for Resident 98 because: “Resident is immobile and makes no attempt to exit or move in bed.” P. Ex. 12 at 140. There is no evidence that Petitioner’s staff discussed this finding or that it modified the resident’s plan of care to address it. In fact, the staff continued to provide the resident with side rails as if no finding of inappropriateness had been made.

In a subsequent assessment, made on September 9, 2016, the staff again found that the resident was immobile and found that she lacked the ability to turn or slide to one side. Id. at 142. It also found that the resident was confused or had a history of agitated behavior. Id. However, the staff recommended continuation of side rail use without

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attempting to reconcile its findings with the conclusion in the previous assessment that use of side rails was no longer appropriate or with the finding that the resident was immobile. Id. at 143. Subsequent assessments continued to note the resident’s immobility and her confused and agitated behavior, but recommended continued use of side rails without attempting to reconcile the clinical findings with the question of whether the side rails were appropriate. Id. at 145-158.

In sum, although Petitioner’s staff identified evidence on multiple occasions that strongly suggested that side rails were no longer appropriate – evidence establishing the resident’s immobility, her blindness, and her advanced dementia – it failed to make any meaningful use of that evidence. It failed to do so even after the resident’s arm became entrapped in side rails.

Petitioner’s failures to properly plan for and assess the use of side rails weren’t confined to the care it provided to Resident 98. Petitioner admitted Resident 68 to its facility in October 2013. Her care plan did not provide for the use of side rails. P. Ex. 15 at 2, 562, 566. Side rail assessments concluded that side rails were not appropriate because the resident was immobile and did not attempt to leave the bed unassisted. Id. at 96, 99, 102. The resident did not have a signed physician’s order for side rails, nor did she execute a consent agreement for side rail use. Notwithstanding, Petitioner’s staff placed the resident in a bed with side rails on her admission to the facility and continuously kept Resident 68 in such a bed up until the April 2018 survey that led to CMS’s noncompliance findings.

Resident 202 suffered from loss of mobility and inability to provide self-care. P. Ex. 18 at 14, 447, 527. The resident’s care plan stated that side rails would be used for safety purposes to assist the resident and staff when the resident was provided with care. Id. at 997. The plan did not suggest that side rails should be maintained at other times. However, Resident 202’s bed was equipped with side rails that were raised continuously, even at times when the resident was not receiving care. Petitioner’s staff made no analysis to determine whether continuously supplying Resident 202 with side rails created unacceptable risks or hazards for this resident.

Petitioner raises several arguments in opposition to my conclusion that it violated regulatory requirements. Primarily, Petitioner argues “no harm, no foul,” in providing care to Resident 98. The gravamen of its argument is that the resident did not become entrapped in her bed’s side rails and that the side rails did not cause her to suffer injury. Petitioner’s post-hearing brief at 4-5. Petitioner asserts that a fracture of the arm that the resident suffered on March 2, 2018, was not due to entrapment of her arm in side rails on that same date. Thus, Petitioner reasons, there is no basis for finding it to be noncompliant with participation requirements.

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This argument is without merit. While a side-rail-caused injury would not be irrelevant to the question of whether Petitioner was noncompliant, noncompliance exists even if Resident 98’s arm was not entrapped and even if the resident suffered no injury from entrapment in her bed’s side rails.1 Petitioner’s noncompliance lies in its failure to properly plan for the resident’s care and its failure to provide the resident with appropriate supervision and protection against accidents. As I have discussed, side rails are inherently hazardous and should only be utilized when the benefits of use outweigh the risks of hazards, and even then, under close supervision. There is at least a potential for harm to a resident any time a facility employs side rails. Thus, failure properly to plan for or utilize side rails always constitutes noncompliance with regulatory requirements.

Here, in providing side rails to Residents 68, 98, and 202, Petitioner failed to make the necessary analysis of whether the residents would benefit from side rails and whether the benefits to the residents, if any, outweighed the risks inherent with side rail use. Petitioner failed to plan how side rails would be used in a way that provided maximum benefit and minimum risk, and it failed adequately to protect its residents. That noncompliance exists even if no resident actually was harmed.

Petitioner argues next that it properly assessed the potential risks of side rails for its residents. Petitioner’s post-hearing brief at 5-10. To support its argument, Petitioner recounts the side rail assessments that its staff made of residents identified as Residents 17, 20, 68, 82, 83, 98, 118, 150, and 202. Id. The care that Petitioner provided to several of these residents – Residents 17, 20, 82, 83, 118, and 150 – is not a basis for CMS’s noncompliance findings.2

As respects the care that Petitioner provided to Residents 68, 98, and 202, the evidence clearly shows that Petitioner’s staff more or less regularly conducted side rail assessments for these residents. I have discussed previously those assessments that the staff performed for Resident 98. The fact that the staff performed assessments for any of these

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residents is not sufficient to prove that Petitioner complied with participation requirements. Performing assessments is a meaningless exercise if a facility’s staff doesn’t utilize the results of these assessments to determine what care to provide to its residents and also to determine how the staff will render that care.

As I have discussed, Petitioner’s staff essentially ignored the assessments that it made of Resident 98. In assessment after assessment the staff found the resident to be immobile. This was a fundamental change in the resident’s condition and should have prompted the staff, at the least, to consider ceasing the use of side rails or changing the way in which they were used. The staff did none of that. Rather, for three and one-half years, Resident 98 lay in a bed with the same side rails that she had received at the inception of her stay at Petitioner’s facility.

Similarly, Petitioner’s staff continued to supply Resident 68 with side rails even though it had assessed their use as unnecessary. In the case of Resident 202, the staff disregarded assessments concluding that side rails were to be utilized only as a positioning aid. Despite these assessments, the staff supplied the resident with side rails that were used continuously.

Next, Petitioner concedes that there may be risks attendant with the use of side rails but contends that its staff took adequate measures to protect its residents against potential harm. Petitioner’s post-hearing brief at 11-17. Petitioner supports this argument with the following assertions:

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I find these arguments to be without merit. The fact that Petitioner had a bed safety policy and that it complied with that policy begs the question of whether Petitioner complied with regulatory requirements in providing care to Residents 68, 98, and 202. CMS did not allege that Petitioner utilized defective side rails or that side rails were placed improperly on residents’ beds. The hazards that these residents encountered were inherent in the continuous use of side rails because the side rails presented an ongoing, constant risk of entrapment even if they were properly maintained. Accidents involving residents and side rails occur even when the side rails are in perfect operating condition. That is because, as Petitioner concedes, side rails are inherently dangerous.

I have discussed previously Petitioner’s argument concerning the assessments that its staff made of its residents. As I have explained, assessments are meaningless absent proof that staff utilizes them to make informed judgments about the benefits versus risks of side rails in a particular instance. Petitioner’s staff manifestly failed to do that in providing care to Residents 68, 98, and 202.

I do not find that Petitioner was absolved of its noncompliance by obtaining consent from Resident 98’s responsible person for continued use of side rails after the resident returned from the hospital in March 2018. That consent does not obviate the fact that the resident received side rails continuously for three and one-half years without the staff making a meaningful determination as to whether the resident would benefit from their use.

Finally, I am not convinced that Petitioner’s asserted compliance with its side rail policy and guidelines absolved it from its noncompliant care that it provided to Residents 68, 98, and 202. Petitioner’s compliance argument rests largely on the fact that it performed side rail assessments for these and other residents. But, and as I have stated, Petitioner has not shown that it actually utilized these assessments to make informed judgments about the utility of side rails for individual residents. Indeed, the evidence pertaining to Resident 98 proves the contrary: the staff disregarded evidence that called into question whether the resident was benefitting from the continued use of side rails.

CMS made two additional allegations of noncompliance. These allegations relate to two residents, identified as Residents 11 and 134. In the case of Resident 11, CMS contends that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.10(e)(1) and 483.12(a)(2). These sections govern the use of restraints by a skilled nursing facility. CMS contends that the resident was observed with a restraint known as a “lap buddy” but that there was no document on record establishing either a physician’s order or an informed consent by the resident or his responsible person for the use of this restraint.

In the case of Resident 134, CMS contends that a licensed practical nurse observed the resident’s spouse strike the resident on the arm. CMS characterizes this incident as an episode of abuse and argues that Petitioner failed to comply with the requirements of 42

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C.F.R. § 483.12(c)(1) and (4) because it did not report this episode to appropriate authorities.

I find it unnecessary to address the merits of either of these allegations. As I explain below, the noncompliance that I have found in this decision amply justifies the $10,000 civil money penalty that CMS determined to impose.

Per-instance civil money penalties are authorized by 42 C.F.R. § 488.438(a)(2). CMS has discretion to impose such a penalty for each instance of noncompliance. I find to be reasonable the $10,000 penalty that CMS determined to impose here.

In considering whether a penalty is reasonable, I may evaluate it pursuant to factors that include the seriousness of a facility’s noncompliance, its compliance history, its culpability, and its financial history. 42 C.F.R. §§ 488.438(f)(1)-(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). Here, the seriousness of Petitioner’s noncompliance is in and of itself sufficient to justify the penalty amount.

As I have explained, side rails are inherently dangerous and should be used only where careful analysis of a resident’s clinical condition establishes that the benefits of use outweigh the risks. Even then, a facility must thoroughly plan how those side rails are to be used and must closely supervise any resident whose bed is equipped with side rails in order to assure that the inherent risks associated with the device’s use do not result in a potentially serious or even lethal accident.

Petitioner failed to follow these requirements in providing care to three residents and therefore put these residents at risk of potentially serious injuries. Petitioner continuously supplied Resident 98 with side rails for a three and one-half year period even though its staff knew that there had been significant changes in the resident’s condition that suggested that supplying this resident with side rails would be of little or no benefit to the resident. Moreover, there was clear evidence that the resident’s condition exacerbated the risks inherent with the use of side rails, and Petitioner’s staff failed to take that evidence into consideration.

In the cases of Residents 68 and 202, Petitioner’s staff supplied these residents with side rails under circumstances where side rail use was not indicated. The staff failed to evaluate these residents and ignored evidence that plainly contraindicated side rails’ use for these residents.

Petitioner offered no evidence to show that the penalty is excessive. Rather, it argues only that no penalty should be imposed against it because it allegedly complied with regulatory requirements.

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I note, finally, that CMS had discretion in this case, as it has in most cases, to impose either a per-instance civil money penalty or a per-diem penalty amount. 42 C.F.R. § 488.438(a)(1). Had it opted to impose a per-diem penalty for the entire period of Petitioner’s noncompliance – which it had the right to do – the penalty amount would have totaled many times the amount of the penalty imposed here. Indeed, the penalty that CMS imposed in this case is minimal considering what CMS could have imposed.

• 1. In fact, the weight of the evidence shows that the resident’s arm was entrapped in a side rail on March 2, 2018. A nursing assistant personally observed the entrapment and freed the resident’s arm. CMS Ex. 8 at 6, 17, 19. Petitioner premises its assertion that the resident’s arm wasn’t entrapped on contentions from third parties who did not witness the incident. Petitioner’s post-hearing brief at 4-5. I find these claims to be less credible than the nursing assistant’s account.
• 2. I find noncompliance with 42 C.F.R. § 483.25(d)(1) and (2) based on the care that Petitioner gave to Residents 68, 98, and 202. I find it unnecessary to evaluate the care that Petitioner gave to other residents.