Central Park Rehabilitation and Nursing Center, DAB CR5030 (2018)

DECISION

Petitioner, Central Park Rehabilitation and Nursing Center, is a long-term-care facility located in Syracuse, New York, that participates in the Medicare program. Its professional staff assessed one of its residents as an elopement risk and planned interventions to keep her safe. Two weeks later, she eloped from the facility with the assistance of unwitting staff members.

Not surprisingly, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety. CMS imposed civil money penalties (CMPs) of $5,000 per day for three days of immediate jeopardy (July 16 through 18, 2015) and $100 per day for 30 days of substantial noncompliance that was not immediate jeopardy (July 19 through August 17, 2015). Petitioner timely appealed CMS’s determinations. CMS now moves for summary judgment.

I grant CMS’s motion. The undisputed evidence establishes that, from July 16 through August 17, 2015, the facility was not in substantial compliance with Medicare program

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requirements; that, from July 16 through 18, 2015, its deficiencies posed immediate jeopardy to resident health and safety; and that the penalties imposed are reasonable.

Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions. Act § 1819. The Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.” 42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a); 42 C.F.R. § 488.20. Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys. Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a); 488.308. The state agency must also investigate all complaints. Act § 1819(g)(4).

Here, responding to a report that police had found a facility resident (identified as R1) wandering the streets of downtown Syracuse, surveyors from the New York State Health Department (state agency) visited the facility and, from July 14 through 20, 2015, conducted a complaint investigation survey. CMS Ex. 23 at 1-2 (Webster Decl. ¶¶ 3, 4); P. Ex. 4. Based on their findings, CMS determined that the facility was not in substantial compliance with two Medicare participation requirements. Specifically:

• 42 C.F.R. § 483.25(h) (Tag F323 – quality of care: accident prevention) at scope and severity level J (isolated instance of noncompliance that poses immediate jeopardy to resident health and safety); and

• 42 C.F.R. § 483.75 (Tag F490 – administration) at scope and severity level J.

CMS Exhibits (Exs.) 1, 2. CMS also determined that the facility’s deficiencies posed immediate jeopardy to resident health and safety.

Following a revisit survey, completed on August 19, 2015, CMS determined that the facility returned to substantial compliance on that date. CMS Ex. 2 at 2.

CMS has imposed against the facility CMPs of $5,000 per day for three days of immediate jeopardy (July 16-18, 2015) and $100 per day for 30 days of substantial

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noncompliance that was not immediate jeopardy (July 19-August 17, 2015), for a total penalty of $18,000 ($15,000 + $3,000 = $18,000). CMS Ex. 3 at 1.

The parties have filed pre-hearing briefs (CMS Br.; P.Br.). CMS filed a motion for summary judgment and memorandum in support (CMS MSJ). CMS submitted 23 exhibits (CMS Exs. 1-23). Petitioner submitted a pre-hearing brief (P. Br.) and a memorandum in opposition to summary disposition (P. Opp. Br.), along with 15 exhibits (P. Exs. 1-15).

Issues

As a threshold matter, I consider whether summary judgment is appropriate.

On the merits, the issues before me are:

• from July 16 through August 17, 2015, was the facility in substantial compliance with Medicare program requirements;

• if, from July 16 through 18, 2015, the facility was not in substantial compliance, did its deficiencies then pose immediate jeopardy to resident health and safety; and

• if the facility was not in substantial compliance, are the penalties imposed – $5,000 per day for the period of immediate jeopardy and $100 per day for the period of substantial noncompliance that was not immediate jeopardy – reasonable.

Discussion

1. CMS is entitled to summary judgment because the undisputed facts establish that, from July 16 through August 17, 2015, facility staff did not provide residents with the supervision they needed; the facility was therefore not in substantial compliance with 42 C.F.R. §§ 483.25(h) and 483.75.1

Summary judgment. Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law. Bartley Healthcare Nursing & Rehab., DAB No. 2539 at 3 (2013), citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986); Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009), and cases cited therein.

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The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.” Livingston Care Ctr. v. Dep’t of Health & Human Servs., 388 F.3d 168, 173 (6th Cir. 2004), quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); see also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing & Rehab. Ctr., DAB No. 1918 (2004). The non-moving party may not simply rely on denials, but must furnish admissible evidence of a dispute concerning a material fact. Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5 (2003).

In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non-moving party. Brightview Care Ctr., DAB No. 2132 at 2, 9 (2007); Livingston Care Ctr., 388 F.3d at 172; Guardian Health Care Ctr., DAB No. 1943 at 8 (2004); but see Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable). However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions. Cf. Guardian Health Care Ctr., DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”).

Program requirement: 42 C.F.R. § 483.25(h) (Tag F323). Under the statute and the “quality of care” regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care. Act § 1819(b); 42 C.F.R. § 483.25. To achieve this, the regulation mandates, among other requirements, that the facility “ensure” that each resident’s environment remains as free of accident hazards as possible and that each resident receives adequate supervision and assistive devices to prevent accidents. The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.” Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10 (2004), aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x. 900 (6th Cir. 2005); accord, Briarwood Nursing Ctr., DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”). A facility is permitted the flexibility to choose the

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methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances. Briarwood at 5; Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d, Windsor Health Care Ctr. v. Leavitt, No. 04-3018 (6th Cir. 2005).

Program requirement: 42 C.F.R. § 483.75 (Tag 490). The facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

Facility policy: elopement prevention.2  The facility had in place an elopement prevention policy, effective June 5, 2015. The policy defined “elopement” as “[w]hen a resident successfully leaves the nursing facility, undetected and unsupervised, and enters into harm’s way” or “when a resident leaves the nursing unit, undetected and unsupervised and enters into harm’s way within the facility.” CMS Ex. 13 at 2.

The policy required staff to assess the elopement risk of every resident – the “cognitively intact” as well as the “cognitively impaired.” It defined “cognitively impaired” as “confused, disoriented, or delusional” and noted that a cognitively-impaired resident could be alert, with memory loss. A cognitively-impaired resident has “impaired decision-making” and makes poor choices that “can have a negative outcome.” CMS Ex. 13 at 2. The policy defined “cognitively intact” as alert and oriented, with the ability to make decisions. CMS Ex. 13 at 2. According to the policy, a cognitively-impaired resident would be assessed for her elopement risk based on her unsafe wandering and need for supervision “to keep [her] out of harm’s way.” Residents who were cognitively intact and capable of making their own decisions would be assessed for their risk of leaving the facility against medical advice. CMS Ex. 13 at 1.

The policy mandated that, upon admission and periodically thereafter, a registered nurse (RN) assess every resident’s elopement risk. For any resident identified as at risk for elopement, the policy required the RN to initiate an individualized care plan and place the resident’s picture in the “[A]dventure [C]lub” binders. The policy directed staff to consider applying a secure care bracelet transmitter (Wanderguard)3  and implementing a

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“safety intervention,” such as periodic safety checks or diversional activities. CMS Ex. 13 at 2-3. The policy does not explain how staff should determine the frequency of the “periodic” checks.

Staff were to note in the resident’s care plan that she had been designated as at risk for elopement. For residents with Wanderguards, the assigned nurse aide was required to check the resident every shift and document (if applicable) that the resident’s Wanderguard was in place and in good repair. CMS Ex. 13 at 3.

Security personnel were required to add the newly-assessed resident to the Adventure Club list, to print out a photo of the resident, and to place copies of the photo in binders at the security desk and on each unit. The policy also directed security personnel to issue an email communication regarding the listing (presumably to the entire staff, although the policy does not say so explicitly). CMS Ex. 13 at 3.

Activity personnel were required to download a digital photo of the resident into the “shared folder,” and the social services department was supposed to complete a “safe to leave” assessment and obtain the required signatures. CMS Ex. 13 at 3.

The policy mandated that all departments and disciplines, including volunteers and agency staff, be in-serviced, at least annually, on, among other matters: elopement risk and identifying residents who are at risk; recognizing behavioral changes indicating potential risk; unsafe wandering; identifying residents who should not be alone in elevators or left unattended; and protecting the elevator code to minimize the resident’s learning it. CMS Ex. 13 at 4.

Missing resident drills were to be conducted at least annually. CMS Ex. 13 at 4.

Finally, the policy included specific procedures that had to be followed when residents, deemed “safe to leave unsupervised,” left the facility. To be eligible, the resident’s physician or nurse practitioner must have assessed her as medically stable, and the facility must have assessed her as “safe to leave.” The resident was required to sign out, specifying her destination, approximate time of return, and telephone number. Upon her return, the resident was required to sign in. CMS Ex. 13 at 6.

Facility policy: safety and supervision of residents. The facility also had a policy, effective May 19, 2015, addressing the safety and supervision of residents. The policy instructed staff to learn a resident’s risk factors by consulting her medical history, physical exam, assessments, and observations. It indicated that an interdisciplinary team would analyze information from assessments and observations to identify accident hazards or risks and to target interventions. Among the interventions: communicating the interventions to all relevant staff; assigning responsibility for carrying them out; providing necessary training; ensuring that the interventions were implemented; and

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documenting them. P. Ex. 8 at 1. Staff were required to monitor the effectiveness of the interventions by ensuring that they were implemented correctly and consistently, evaluating their effectiveness, modifying or replacing them, as necessary, and evaluating the new or revised interventions. P. Ex. 8 at 1-2.

The policy identified resident supervision as a “core component” of its “systems approach” to safety and noted that the type and frequency of supervision could vary based on changes in the environment or the resident’s condition. P. Ex. 8 at 2.

Resident 1 (R1). R1 was a 71-year-old woman, admitted to the facility on June 9, 2015, suffering from left hand cellulitis and abscesses, metabolic encephalopathy, new onset tonic clonic (formerly referred to as grand mal) seizures, and other disorders. CMS Ex. 9; P. Ex. 1 at 6. She had recently been hospitalized to treat the cellulitis. At the time of her hospital admission, on June 2, she was agitated and very confused, with paranoid ideation. P. Ex. 3 at 1. On June 5, while still hospitalized, she suffered a generalized tonic clonic seizure. P. Ex. 2 at 2; P. Ex. 3 at 1. Nevertheless, by June 8, she seemed to have improved. She was functional and oriented to time, place, and person and, according to her hospital records, was to be discharged to her home. P. Ex. 3 at 2. But she did not return home. Her facility admission records indicate that, before the hospital could discharge her, she “presented . . . with walking around and confused.” P. Ex. 2 at 1. She was therefore admitted to the facility, where her husband already resided, for short-term rehabilitation. P. Ex. 2 at 4.

According to her initial physical therapy assessment, R1 was referred for physical therapy because of increased weakness and because she required assistance with all activities of daily living and functional tasks. She was a fall risk. P. Ex. 1 at 6, 7.

At 3:06 p.m. on the day of her admission, a registered nurse completed an elopement risk assessment and determined that R1 was not at risk for elopement.4  CMS Ex. 9.

Several hours later, at about 7:10 p.m., nursing notes describe R1 as “pleasantly confused.” She was wandering about the unit, thinking she was in the hospital and looking for her husband, although he was in the same room. R1’s daughter told the nurse that her mother was confused; she expressed concern that R1 would wander off the unit and get lost. She told the nurse that another facility (where R1 had apparently resided) applied a Wanderguard in order to keep her safe. The nurse explained that a Wanderguard would not be available until the next day. In the meantime, she assured the daughter that all staff were informed, that R1’s picture was at the front desk, and that R1 was “on frequent visual checks.” CMS Ex. 11 at 2 (emphasis added); see CMS Ex. 12 at 2; CMS Ex. 22 at 1 (confirming interventions: unit staff educated; picture placed in

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adventure club book and sent to security to update all books as to R1’s status as an elopement risk; “periodic safety checks”; the frequency of such checks is not defined).

At about the same time as she entered the nurse’s note, the RN completed a new elopement risk assessment.5  Her assessment differed from the earlier one because she checked “yes” instead of “no” to a series of critical questions regarding the resident’s behavior and mental state: is she pacing, looking for relatives and expressing a need to perform outside tasks; is she wandering on the unit; is she cognitively impaired/demonstrates impaired decision making. The updated assessment concluded that R1 was at risk for elopement. CMS Ex. 10. The RN opted for two interventions: placing the resident’s picture at the reception desk; and periodic safety checks. CMS Ex. 10 at 2. The RN did not further define “periodic,” and Petitioner has not come forward with a written policy, care plan, or other documentation establishing how often staff were supposed to check on R1. (See discussion below).

Neither party submitted a copy of R1’s care plan, but I assume that the RN, in accordance with facility policy, noted in the care plan that R1 had been designated an elopement risk.

During the survey, the same RN confirmed that she had been “very concerned” about the resident’s confusion and history of wandering; she thought that R1 was at a moderate to high risk of elopement and needed a Wanderguard. But no Wanderguard was available, although the facility had expected a shipment on June 20 (the shipment did not arrive until June 24). CMS Ex. 22 at 2; CMS Ex. 23 at 2 (Webster Decl. ¶ 8). Petitioner has not come forward with evidence (e.g., a statement from the RN) suggesting any dispute about whether these were the RN’s concerns.

Thereafter, according to the undisputed evidence in R1’s medical record, her confusion and wandering continued. A nursing note dated June 15 describes R1 as “alert with periods of confusion.” She was not able to tell the nurse why she was there; she thought that she was visiting her husband and never went home. She also thought that she was at the hospital. She worried that her family didn’t know where she was and that she needed to call her neighbors to see if they could take care of her dogs. CMS Ex. 11 at 2. In the days that followed (June 16, 17, 18, 19, and 22), staff continued to describe R1 as alert, confused, and, on occasion, “anxious.” CMS Ex. 12 at 1, 2.

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A physician assessment, dated June 17, 2015, reported that R1 thought she had been rehabilitated, and she wanted to go home. P. Ex. 2 at 4. However, R1 continued to suffer from dementia, recent delirium, and new-onset epilepsy, which was being treated. P. Ex. 2 at 4. The physician’s plan included following her anti-seizure-medication levels for the “next few days” and providing her a safe environment until her potential discharge about eight days later. P. Ex. 2 at 4.

On June 19, R1 told staff that she wanted to go home.6  On the afternoon of June 22, staff reported that she “wanders the unit without difficulty.” CMS Ex. 11 at 1.

The elopement. By June 23, R1 still did not have a Wanderguard. CMS Ex. 23 at 2 (Webster Decl. ¶ 9). On that day, after finishing her lunch, she returned to her room, unaccompanied. Sometime thereafter, she left her room, apparently unobserved, and took the elevator to the first floor. CMS Ex. 12 at 1. A nurse aide on the first floor reported that R1 got off the elevator, approached her, and told her that she had been upstairs visiting her husband but was lost and trying to find her way out. The nursing staff scheduler was nearby, and the nurse aide asked her to assist R1. The scheduler escorted R1 to the front door and watched her leave. CMS Ex. 12 at 1-2; CMS Exs. 18, 19.

The facility administrator later confirmed that video surveillance showed R1 walking out the front door at about 1:00 p.m. CMS Ex. 22 at 2.

No one noticed that the resident was gone. At 1:49 p.m., Syracuse police called the facility to report that they had found her wandering around downtown and would return her to the facility. CMS Ex. 12 at 1; CMS Ex. 22 at 2; CMS Ex. 23 at 1, 3 (Webster Decl. ¶¶ 3, 14).

She was not injured, and, when the police brought her back, staff described her as alert “with confusion.” CMS Ex. 11 at 1. The facility placed a Wanderguard on her ankle and put her on “frequent visual checks,” although, again, nothing specifies what “frequent” meant. CMS Ex. 11 at 1; CMS Ex. 22 at 2.

Facility noncompliance: quality of care. Based on these undisputed facts – derived almost entirely from the facility’s own documents – the facility was not ensuring that R1 received adequate supervision. Nursing staff identified her as an elopement risk and proposed to keep her safe by maintaining her picture at the reception desk (so that security and other personnel would identify her and prevent her departure) and by directing assigned staff members to check on her “periodically.” The facility’s policy required security personnel to issue an email communication to staff alerting them that

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the resident had been listed as an elopement risk. Consistent with this requirement, the RN assured R1’s family that all staff were informed that R1 was an elopement risk. But, as Petitioner concedes, not all facility staff knew this (or even that R1 was a resident); and, when she departed, no one at the reception desk bothered to check the Adventure Club binder.

Moreover, unlike the individuals who allowed R1 to leave the facility, all the staff on her unit presumably knew that she was a resident and an elopement risk. Yet, she managed to enter the elevator and leave the unit, undetected, which, according to facility policy, is itself an elopement. CMS Ex. 13 at 2. This shows wholly inadequate supervision. And whoever was charged with performing “periodic safety checks” was not even aware that she was gone. Any one of these failures puts the facility out of substantial compliance with 42 C.F.R. § 483.25(h).

Petitioner’s defenses. Petitioner, however, justifies its staff’s actions by pointing out that one of the employees “held the subjective belief, based on her personal experience, that the woman was a visitor, not a resident.” P. Opp. Br. at 2. Petitioner claims that it had no way of knowing that R1 was an elopement risk because she was an “independent, capable individual” who, before she was admitted, regularly visited her husband in the facility. But R1’s most recent elopement assessment identified her as an elopement risk. That a resident assessed as at risk for elopement might attempt to elope is hardly the “unlikely scenario” that Petitioner describes. P. Br. at 2.

I accept that R1 had been an “independent, capable individual” who lived alone, drove a car, and visited her husband at the facility. But that was before her infection, hospitalization, seizure, and the accompanying decline in her mental faculties and behaviors. Indeed, she was institutionalized for her rehab largely because she had been confused and wandering. P. Ex. 1 at 21, 22 (indicating memory loss and a June 9 BIMS [brief interview for mental status] score of 8, putting her on the low end of moderately impaired); P. Ex. 2 at 4.

Petitioner has not produced evidence that R1’s condition improved in the two weeks following her admission. In fact, the opposite is true. Petitioner has come forward with additional medical evidence establishing that, notwithstanding periods of lucidity, R1’s dementia, delirium, and epilepsy continued. P. Ex. 1 at 5 (“Mild confusion and short-term memory deficits persist”). Petitioner’s unsupported claims and gratuitous conclusions that R1’s condition improved do not qualify as evidence of specific facts showing that a dispute exists. See Ill. Knights Templar, DAB No. 2274 at 4.

In any event, had R1’s condition improved, the facility had in place policies that would have allowed her to leave the facility unsupervised. CMS Ex. 13 at 6. But those policies required that her physician assess her as “medically stable” and that staff assess her as “safe to leave.” CMS Ex. 13 at 6. As outlined above, no physician or staff member who

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had contact with R1 ever suggested that she was medically stable or safe to leave. See, e.g., P. Ex. 2 at 4 (finding that she continued to suffer from dementia, delirium, and new-onset epilepsy and proposing to follow her medication levels and provide “a safe environment”).

Petitioner also defends its actions regarding “frequent checks.” It claims that the facility had in place “an extensive system, with redundancies [that] included frequent checkpoints during which staff interacted with and monitored their residents, in addition to specific documented monitoring for those residents assessed to require it.” P. Opp. Br. at 10. In support, Petitioner cites to policies and training that it implemented after R1’s elopement. P. Ex. 10 (sign-in sheets for in-service training sessions held June 23-July 3, 2015); P. Ex. 12 at 3 (Calli Decl. ¶ 10) (citing P. Ex. 7, policies effective June 24, 2015).7  Petitioner produced no written policy, in effect at the time of R1’s elopement, that explains what staff were required to do for a resident who needed “frequent monitoring.” Nor has Petitioner produced any instructions to staff specifying how frequently they should monitor R1. When the surveyors asked, staff were not able to explain what “frequent monitoring” meant. See CMS Ex. 15; CMS Ex. 22 at 3; CMS Ex. 23 at 3 (Webster Decl. ¶ 11). In the absence of such instructions, staff followed the policy instructions for monitoring a resident’s Wanderguard, which was not an acceptable level of supervision for R1, who had no Wanderguard. CMS Ex. 13 at 3.

Petitioner produces a document it identifies as R1’s electronic medication assistance record (eMAR). According to Facility Administrator Patrick Calli, this system prompts nursing staff to check on a resident requiring safety checks at scheduled times and to document the safety checks on each shift. P. Ex. 6; P. Ex. 13 at 3 (Calli Decl. ¶ 10). When staff are supposed to check on a resident, a banner flashes on a screen with that resident’s information. To reset the banner, the staff member clicks on a box indicating that the task has been performed. P. Ex. 11 at 1 (Calli Decl. ¶ 3).

Initially, the document presents three major problems. First, it does not seem to reflect the care provided to R1, at least not exclusively. All of the names have been blacked out, and the document includes multiple entries, dated June 12, 14, 16, 19, 20, 21, and 22, that refer to staff checking the resident’s Wanderguard; we know that R1 had no Wanderguard at that time. P. Ex. 6 at 1-2. Administrator Calli claims that these were likely inadvertent errors. The box labeled “visually checked resident” is close to the box for “Wanderguard in place” and “Wanderguard functioning.” Staff clicked on the wrong box, which caused an inaccurate entry into the eMAR, according to Administrator Calli. P. Ex. 11 at 1 (Calli Decl. ¶ 4).

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Second, Petitioner concedes that a “late entry” in the system means that the service was not provided at the time indicated. For example, an entry indicates “TAR” at 2:00 p.m. on June 23. But, as Petitioner explains, the interaction did not occur until later, 2:21 p.m. P. Opp. Br. at 11, citing P. Ex. 1 at 12 and P. Ex. 11 at 10-11 (Calli Decl. ¶ 32). Given the number of “late entries” in the system, it seems that the eMAR may not always reliably indicate when particular services were provided. See, e.g., P. Ex. 6 at 1, 8, 10, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 25, 26.

Third, some of the entries do not appear to have required staff interaction with R1. For example, “ADL Bed Mobility” says “Self-Performance: 0. Independent: Support 0. No setup or physical help from staff.” P. Ex. 6 at 3. There are similar entries for “Transfer” and “Toilet Use.” P. Ex. 6 at 3-9.

All of this raises some obvious questions: why accept as reliable any system for which 19% of the “Elopement Precaution” entries are admittedly erroneous;8  multiple other entries may not accurately reflect the times of the interaction; and other entries do not necessarily reflect actual staff-resident interaction. Putting these questions aside, however, and drawing all inferences in the light most favorable to Petitioner, I accept, for purposes of summary judgment, that this document roughly reflects the times staff implemented their interventions; that references to R1’s Wanderguard actually mean “visual checks”; and that all entries represent physical interactions between R1 and staff. Even accepting these premises, however, the document supports CMS’s assertion that “Elopement Precaution” checks were few and far between – just three a day. P. Ex. 6 at 1-2. On the day of her elopement, June 23, for example, a nurse aide checked on her at 3:44 a.m.; another nurse aide recorded (albeit a late entry) that she visually checked on R1 nine hours later, at 12:45 p.m. P. Ex. 6 at 1.9

The eMAR includes virtually every possible staff-resident interaction. Petitioner argues that I should consider all of these entries as part of its “plan” to monitor R1. First, this is hardly an effective system for ensuring adequate supervision of residents most at risk for elopement. The facility relies on its staff’s ordinary interactions with its residents, adding just three visual checks every 24 hours for the resident who requires frequent monitoring.

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Such a haphazard approach does not ensure that each resident receives the level of supervision that she requires in order to stay safe.

And review of R1’s eMAR confirms that the approach did not ensure that staff adequately supervised R1. According to the document, it was not unusual for several hours to elapse between staff interventions. For example, prior to her elopement on June 23, R1 had the following interactions with staff, leaving gaps in supervision ranging from an hour and a half to three hours, more than ample time for her to exit the facility:

June 23 eMAR
12:54 a.m.      toilet use/ADL bed mobility                     (P. Ex. 6 at 3)
3:44 a.m.        elopement precaution                             (P. Ex. 6 at 1)
5:27 a.m.        TAR                                                        (P. Ex. 6 at 10)
8:34 a.m.        MAR                                                       (P. Ex. 6 at 10)
10:00 a.m.      TAR [Late Entry]                                   (P. Ex. 6 at 10)
10:55 a.m.      skin check                                              (P. Ex. 6 at 23)
12:45 p.m.      elopement precaution [Late Entry]        (P. Ex. 6 at 1)

The day before her elopement was similar, with gaps in supervision of up to nearly four hours:

June 22 eMAR
3:24 a.m.                       elopement precaution                                  (P. Ex. 6 at 1)
4:16 a.m.                       TAR                                                             (P. Ex. 6 at 11)
5:47 a.m.                       toilet use/transfer/ADL bed mobility             (P. Ex. 6 at 3)
9:13 to 9:16 a.m.           TAR/MAR                                                    (P. Ex. 6 at 11)
1:12 p.m.                       TAR                                                             (P. Ex. 6 at 11)
1:51 p.m.                       elopement precaution [Wanderguard]        (P. Ex. 6 at 1)

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June 22 eMAR cont.
5:00 p.m.                       TAR [Late Entry]                                        (P. Ex. 6 at 11)
5:32 to 5:33 p.m.           eating/toilet use                                            (P. Ex. 6 at 3)
10:00 p.m.                     MAR/TAR                                                     (P. Ex. 6 at 10)
10:13 to 10:14 p.m.       elopement precaution/eating/toilet use          (P. Ex. 6 at 1, 3)10

Thus, because the facility had no reliable system in place to ensure adequate supervision, and, in fact, did not adequately supervise R1, it was not in substantial compliance with 42 C.F.R. § 483.25(h).

Facility noncompliance: administration. A finding of substantial noncompliance in the facility’s administration may derive from findings of substantial noncompliance in other areas.

[W]here a facility has been shown to be so out of compliance with program requirements that its residents have been placed in immediate jeopardy, the facility was not administered in a manner that used its resources effectively to attain the highest practicable physical, mental, and psychosocial well-being of each resident.

Asbury Ctr. at Johnson City, DAB No. 1815 at 11 (2002); Odd Fellow & Rebekah Health Care Facility, DAB No. 1839 at 7 (2002); Stone Cnty. Nursing & Rehab. Ctr., DAB No. 2276 at 15-16 (2009). As discussed below, I find that the facility’s deficiencies posed immediate jeopardy to resident health and safety, which, by itself, justifies the finding that the facility was not in substantial compliance with 42 C.F.R. § 483.75.

Moreover, the failures here were, in large part, directly attributable to the facility’s administration. Although the facility had policies in place to prevent elopements, those policies provided staff virtually no guidance on “frequent monitoring.” This could have been remedied had R1’s care plan included specific instructions, but no evidence presented here indicates that it did so. This also puts the facility out of substantial compliance with 42 C.F.R. § 483.75.

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2. CMS’s determination that the facility’s substantial noncompliance posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy. Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301. CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” Barbourville Nursing Home, DAB No. 1931 at 27-28 (2004), citing Koester Pavilion, DAB No. 1750 (2000); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).

It is well-settled that the unsupervised wandering and elopement of frail and demented individuals presents very real and serious dangers:

The likelihood of serious harm is weighed . . . by considering what the episode reveals about dangers to which residents in the facility were exposed by the identified problems and how likely such dangers were to result in serious harm. . . . [T]he fact that someone who was severely mentally impaired and unable to care for her own safety could wander off entirely unnoticed and not be sought until strangers rescued her presents significant likelihood that vulnerable residents might encounter the very dangers [that the facility] calls “the usual hazards of wandering away,” such as falls, traffic, etc.

Century Care of Crystal Coast, DAB 2076 at 24 (2007). Where, as here, a facility’s deficiencies allow a confused resident, suffering from dementia, episodes of delirium, and seizures, to leave the facility undetected, the Departmental Appeals Board has “no trouble finding a crisis situation” that poses immediate jeopardy to resident health and safety. Mississippi Care Ctr. of Greenville, DAB No. 2450 at 16 (2012); see also Glenoaks Nursing Ctr., DAB No. 2522 at 17 (2013).

Because the facility’s deficiencies were likely to cause serious harm to vulnerable residents, CMS’s determination that the deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.

3. CMS’s determinations as to the duration of the facility’s substantial noncompliance and immediate jeopardy are consistent with statutory and regulatory requirements.

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Once a facility has been found to be out of substantial compliance (as Petitioner was here), it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again. Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab Ctr., DAB No. 2146 at 3 (2008); Lake City Extended Care, DAB No. 1658 at 12-15 (1998). The burden is on the facility to prove that it is back in compliance, not on CMS to prove that deficiencies continued to exist. Asbury Care Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002).

The facility must show that the incidents of noncompliance have ceased and that it has implemented appropriate measures to ensure that similar incidents will not recur. Libertywood Nursing Ctr., DAB No. 2433 at 15 (2011), citing Life Care Ctr. of Elizabethton, DAB No. 2356 at 16 (2011); accord, 42 C.F.R. § 488.456(a) and (e); Hermina Traeye Mem’l Nursing Home, DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation “acceptable to CMS” showing that it was in substantial compliance and was capable of remaining in substantial compliance on the earlier date); Cross Creek Care Ctr., DAB No. 1665 (1998). A facility’s return to substantial compliance usually must be established through a resurvey. 42 C.F.R. § 488.454(a); Ridgecrest at 2-3.

Further, if CMS accepts a deficient facility’s plan of correction, the facility must then timely implement all of the steps that it identified in the plan as necessary to correct the cited problems. Cal Turner Extended Care Pavilion, DAB No. 2030 at 19 (2006); see also Meridian Nursing Ctr., DAB No. 2265 (2009); Lake Mary Health Care, DAB No. 2081 at 29 (2007).

Finally, CMS’s determination that a facility’s ongoing noncompliance remains at the level of immediate jeopardy during a given period “is subject to the clearly erroneous standard of review under [42 C.F.R. §] 498.60(c)(2).” Life Care of Elizabethton, DAB No. 2367 at 16, quoting Brian Ctr., DAB No. 2336 at 7-8 (2010).

Here, at least as early as June 2015, the facility’s practices put it out of substantial compliance with program requirements and posed immediate jeopardy to resident health and safety. Without explaining why, CMS opted to delay imposing penalties until July 16, when it imposed the $5,000 per day penalty. During the survey, it determined that the facility “employed corrective measures . . . that removed the immediate jeopardy.” CMS Exs. 2, 3, 5.

Immediately following R1’s elopement, the facility provided her with a Wanderguard. It also amended its elopement prevention policy, effective June 24, 2015, to require that staff direct to a visitor log sign-out any person requesting assistance in finding the exit. The sign-out would be kept at the reception desk. Security was charged with ensuring that people exiting the facility are signing out in the visitor log. P. Ex. 7 at 3. Staff

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attended in-service training sessions to learn of the policy changes, and the facility began to audit these changes. P. Ex. 10; see CMS Exs. 2, 3, 5.

While these changes may have solved the facility’s immediate (and most embarrassing) problem of facility staff’s having assisted a resident in her elopement, policy changes, in-service training, and promises of change, by themselves, are not sufficient to ensure that the cited deficiencies will not recur. As I noted in Premier Living and Rehab Ctr., the facility must follow up with staff to verify that they understand the training, have implemented the necessary changes, and that the changes, in fact, corrected the problem. DAB CR1602 (2007), aff’d, DAB No. 2146 (2008); see also Sandwich Rehab & Health Care Ctr., DAB CR4728 at 24 (2016). This cannot be accomplished in a few training sessions, as the facility implicitly acknowledged when, in its plan of correction, it set later completion dates.11

The facility ultimately promised to complete its corrections on August 18, 2015, and CMS has accepted that as the date the facility returned to substantial compliance. CMS Ex. 1 at 1, 9, 11.

The facility had earlier submitted a plan of corrections, which the state agency rejected as unacceptable. CMS Ex. 6. I have no authority to review the state agency’s determination to reject a provider’s plan of correction. That action is not listed as an initial determination and is therefore not reviewable. 42 C.F.R. §§ 498.3(b); 498.5; HRT Lab, Inc., DAB No. 2118 at 11 (2007); Hermina Traeye Mem’l Nursing Home, DAB No. 1810 at 13 (In affirming the termination of a provider, the administrative law judge “properly concluded that he lacked the authority to adjudicate the question of whether [CMS] abused its discretion in deciding to reject the [plan of correction].”).

The facility has thus not met its burden of establishing that it alleviated the immediate jeopardy nor that it returned to substantial compliance any earlier than the dates CMS has designated.

4. The penalties imposed are reasonable.

To determine whether a civil money penalty is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f): (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating factor. The factors in 42 C.F.R. § 488.404 include: (1) the scope and severity of the deficiency; (2) the

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relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors. I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion. Barn Hill Care Ctr., DAB No. 1848, at 21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

Here, CMS imposes a penalty of $5,000 per day for each day of immediate jeopardy, which is at the low end of the immediate jeopardy range ($3,050 to $10,000). 42 C.F.R. §§ 488.408(e)(1)(iii); 488.438(a)(1)(i). For the period of substantial noncompliance that was not immediate jeopardy, CMS imposes a penalty of just $100 per day, which is at the very low end of the applicable penalty range ($50 to $3,000). 42 C.F.R. §§ 488.408(d)(1)(iii); 488.438(a)(1)(ii). Considering the relevant factors, these penalties are reasonable.

The facility has a less-than-stellar history. It was consistently out of substantial compliance for the five annual surveys immediately preceding this complaint investigation. Notably:

• for the annual recertification survey completed March 2, 2015, the facility was not in substantial compliance with the quality of care regulation and the regulation that governs preventing pressure sores (42 C.F.R. §§ 483.25 and 483.25(c) – Tags F309 and F314) at scope and severity level G, which means that the deficiencies caused actual harm to resident health and safety. CMS Ex. 4 at 1.

• for the annual recertification survey completed July 17, 2014, the facility was not in substantial compliance with regulations governing housekeeping and maintenance (42 C.F.R. § 483.15(h)(2) – Tag F253) and dietary services/sanitary conditions (42 C.F.R. § 483.35(i) – Tag F371) at scope and severity level E, which means a pattern of deficiencies that presented the potential for more than minimal harm. CMS Ex. 4 at 1.

• for the annual recertification survey completed May 30, 2013, it was not in substantial compliance with the regulation governing emergency preparedness (42 C.F.R. § 483.75(m) – Tag F517) at scope and severity level F, which means that the deficiency was widespread and presented the potential for more than minimal harm. CMS Ex. 4 at 2.

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• for the annual recertification survey completed June 1, 2012, the facility was not in substantial compliance with multiple regulations: quality of life/dignity (42 C.F.R. § 483.15(a) – Tag F241); dietary services (42 C.F.R. §§ 483.35(c), 483.35(d), and 483.35(i) – Tags F363, F365, and F371); and infection control (42 C.F.R. § 483.65 – Tag F441), again at scope and severity level E. CMS Ex. 4 at 2.

• for the annual recertification survey completed April 6, 2011, the facility was not in substantial compliance with regulations governing resident rights (42 C.F.R. § 483.10(b)(1) – Tag F156) and dietary services (42 C.F.R. §§ 483.35(d) and 483.35(i) – Tags F365 and F371), at scope and severity level E. CMS Ex. 4 at 2.

The facility’s history alone justifies imposing CMPs that are greater than the minimum.

Petitioner does not claim that its financial condition affects its ability to pay the CMP.

With respect to the remaining factors, I consider that the deficiencies here were serious. For this elderly and infirm population, failing to prevent elopement can have severe, even fatal, consequences. Yet the facility did not have an effective system in place for supervising those at risk and, in fact, did not adequately supervise those residents. For this, the facility is culpable and the penalties imposed are reasonable.

Conclusion

For all of these reasons, I find that, from July 16 through August 17, 2015, the facility was not in substantial compliance with Medicare program requirements; from July 16 through 18, 2015, its deficiencies posed immediate jeopardy to resident health and safety; and the penalties imposed – $5,000 per day for three days of immediate jeopardy and $100 per day for 30 days of substantial noncompliance that was not immediate jeopardy – are reasonable.

1. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.
• back to note 1
2. Petitioner cites to a slightly different version of its elopement policy. P. Ex. 7. However, that policy was not effective until June 24, 2015, the day after R1’s elopement. I discuss below the new policy’s effect on the duration of the facility’s substantial noncompliance.
• back to note 2
3. A Wanderguard is a security alarm that normally attaches to a resident’s ankle. It alerts staff when the resident approaches an exit. If a resident enters an elevator, the Wanderguard locks the elevator and sounds an alarm. CMS Ex. 22 at 2-3; CMS Ex. 23 at 2, 3 (Webster Decl. ¶¶ 8, 12).
• back to note 3
4. Even though this assessment lists delirium and dementia among R1’s diagnoses, it also indicates that she has no mental illness that would make her unpredictable. CMS Ex. 9.
• back to note 4
5. Petitioner points out, accurately, that facility staff assessed R1 “not once, but twice” on the day of her admission. P. Opp. Br. at 2, 9. While this is true, it highlights the shortcomings of the first elopement assessment, which seems to have disregarded the facility’s own admission records, the family’s report, and the resident’s well-documented behaviors. See P. Ex. 8 at 1 (policy directing staff to consider the resident’s medical history, physical exam, assessments, and observations).
• back to note 5
6. According to the facility’s elopement assessment tool, R1’s verbalizing “I want to go home” put her at greater risk for elopement. CMS Ex. 10 at 2.
• back to note 6
7. Petitioner also cites CMS Ex. 12 at 2. P. Opp. Br. at 10. But that is a page from the facility’s elopement report to the state agency. It says nothing about the system the facility had in place to implement calls for “increased monitoring” or “frequent checks.”
• back to note 7
8. Of the 37 entries labeled “Elopement Precautions,” seven document that staff checked the resident’s Wanderguard and found it functioning. P. Ex. 6 at 1-2.
• back to note 8
9. The same nurse aide wrote separately, without mentioning the time, that the last time she saw R1, prior to her elopement, “was at the lunch table during lunch.” P. Ex. 5. Curiously, for June 23, the eMAR includes no entry for “Eating” prior to 4:05 p.m., raising additional questions (which I do not consider here) about how reliable the entries are.
• back to note 9
10. Petitioner emphasizes the multiple interactions that occurred on the day of her admission, June 9, and the following day. These early days, with their multiple assessments and orientations, are hardly representative of the level of supervision staff provided during the course of R1’s stay at the facility.
• back to note 10
11. I note that the facility ultimately amended its policy to require that staff apply Wanderguards to all residents at risk for elopement.
• back to note 11