AristaCare at Cherry Hill, DAB CR5459 (2019)

DECISION

AristaCare at Cherry Hill (AristaCare or Petitioner) challenges the Centers for Medicare & Medicaid Services’ (CMS’s) determination that it was not in substantial compliance with the Medicare program participation requirements at 42 C.F.R. § 483.25(h).1 AristaCare also contends that CMS clearly erred in concluding that the facility’s alleged noncompliance posed immediate jeopardy to resident health and safety and that the remedy imposed, a $79,200.00 civil money penalty (CMP), is unreasonable. For the reasons discussed below, I conclude that: 1) Petitioner did not comply substantially with Medicare participation requirements; 2) CMS’s finding of immediate jeopardy was not clearly erroneous; and 3) the CMP imposed is reasonable.

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I. Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Cherry Hill, New Jersey. See, e.g., CMS Exhibit (Ex.) 1 at 1. Surveyors from the New Jersey Department of Health (state agency) completed a survey of Petitioner’s facility on March 12, 2015. Id.  The state agency found that the facility was not in substantial compliance with Medicare participation requirements and the conditions constituted immediate jeopardy to resident health and safety.2 Id. at 5-30. Based on the survey findings, CMS determined that the facility was not in substantial compliance with 42 C.F.R. § 483.25(h) (Tag F323) and the immediate jeopardy existed from March 3, 2015 through March 11, 2015. CMS Ex. 2 at 1-2. By letter dated May 27, 2016, CMS imposed a civil money penalty (CMP) of $8,800 per day for nine days of immediate jeopardy (March 3, 2015 through March 11, 2015), for a total CMP of $79,200. Id.

On July 22, 2016, Petitioner requested a hearing to dispute CMS’s findings that it was not in substantial compliance with 42 C.F.R. § 483.25(h) and that its noncompliance resulted in immediate jeopardy.3 On July 26, 2016, I issued an Acknowledgment and Pre-Hearing Order (Pre-Hearing Order) establishing a briefing schedule. In compliance with my Pre‑Hearing Order, CMS and Petitioner filed pre-hearing exchanges, including pre‑hearing briefs (CMS Pre-Hr’g Br. and P. Pre-Hr’g Br., respectively), exhibit and witness lists, and proposed exhibits. Within its pre-hearing brief, CMS moved for summary judgment, which Petitioner opposed in its pre-hearing brief.

Petitioner requested to cross-examine CMS’s witness. I held a hearing by video teleconference on July 20, 2017, at which Petitioner’s counsel cross-examined CMS’s witness (Pamela Lebak). See Transcript (Tr.) at 3. I admitted CMS Exs. 1-13 and P. Exs. 1-15 into the record. Tr. at 8.

After the hearing, CMS and Petitioner filed post-hearing briefs (CMS Post-Hr’g Br. and P. Post-Hr’g Br., respectively). In its post-hearing brief, CMS renewed its motion for summary judgment. Neither party filed a response brief.

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II. Issues

The issues in this case are:

III. Jurisdiction

I have jurisdiction to hear and decide this case. Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

IV. Discussion

A. Statutory and regulatory framework

The Act sets requirements for SNF participation in the Medicare program. The Act authorizes the Secretary of the United States Department of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions. Act § 1819 (42 U.S.C. § 1395i-3). The Secretary’s regulations are found at 42 C.F.R. parts 483 and 488.

A facility must maintain substantial compliance with program requirements in order to participate in the program. 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. A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B. Id. “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20. The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements. 42 U.S.C. § 1395i-3(h)(2). The regulations specify the enforcement remedies that CMS may impose. 42 C.F.R.

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§ 488.406. Among other enforcement remedies, CMS may impose a per-day CMP for the number of days a SNF is not in substantial compliance. 42 C.F.R. § 488.430(a). A per-day CMP may range from either $50 to $3,000 per day for less serious noncompliance, or $3,050 to $10,000 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 42 C.F.R. § 488.438(a)(1). “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.

B. Findings of Fact, Conclusions of Law, and Analysis

1. Summary judgment is not appropriate because Petitioner has raised a genuine dispute of material fact.4

Summary judgment is appropriate if there is “no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.” Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012) (citations omitted). In order to prevail on a motion for summary judgment, the moving party must show that there is no genuine dispute of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law. Id. If the moving party meets this initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial . . . .’” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact — a fact that, if proven, would affect the outcome of the case under governing law.” Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010).

In evaluating a motion for summary judgment, an administrative law judge does not address credibility or evaluate the weight of conflicting evidence. Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009). Rather, in examining the evidence to determine the appropriateness of summary judgment, an administrative law judge – or any judicial officer – must examine all pleadings in the light most favorable to the non‑moving party. Livingston Care Ctr. v. Dep’t. of Health & Human Servs., 388 F.3d 168, 172 (6th Cir. 2004). “[A]t the summary judgment stage the judge’s function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).

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After reviewing the evidence and drawing all reasonable inferences in the light most favorable to the non-moving party, I find that Petitioner has come forward with evidence that raises genuine issues of material fact in this case. Consequently, I deny CMS’s motion for summary judgment and decide this case based on the documentary and testimonial evidence in the record.

2. Petitioner was not in substantial compliance with Medicare participation requirements found at 42 C.F.R. § 483.25(h) (Tag F323).

Program requirement: 42 C.F.R. § 483.25(h) (Tag F323). Subsection 483.25(h) is part of the quality of care regulation at 42 C.F.R. § 483.25, which states that “[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.” Subsection 483.25(h) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:

The facility must ensure that —

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

Appellate panels of the Departmental Appeals Board (DAB) have held that subsection 483.25(h)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.” Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 589 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)). Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision under all the circumstances.” Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub nom, Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

Petitioner’s Policies:

Door Locking. Petitioner’s undated Door Locking policy had the stated purpose to “ensure the safety of our residents and staff.” CMS Ex. 11 at 1. The policy provided, “[A]ll doors [will] be locked at night.” Id.  The policy further states that, “[w]hen the receptionist leaves at night, she will let the nursing supervisor know so that she can lock

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the main entrance door or tell the receptionist to lock it. The supervisor will make sure all other doors are locked, as well. Once doors have been locked, all visitors and/or residents that need entry will be buzzed in by the supervisor.” Id.

Elopement. Petitioner’s undated Elopements policy provided that staff shall investigate and report all cases of missing residents. CMS Ex. 11 at 2. The policy further requires staff to “promptly report any resident who tries to leave the premises or is suspected of being missing to the Charge Nurse or Director of Nursing.” Id.

If an employee discovers that a resident is missing from the facility, he/she shall:

a. Determine if the resident is out on authorized leave or pass

b. If the resident was not authorized to leave, initiate a search of the building(s) and premises

c. If the resident is not located, notify the Administrator and the Director of Nursing Services, the resident’s legal representative (sponsor), the Attending Physician, law enforcement officials, and (as necessary) volunteer agencies (i.e., Emergency management, Rescue Squads, etc.)

d. Provide search teams with resident identification information

e. Initiate an extensive search of the surrounding area.

Id.

Smoking Program. Petitioner’s Smoking Program policy, effective January 2012 with a revision date of August 2013, had the stated purpose “to allow residents who smoke, to do so safely and without injury to themselves and others.” CMS Ex. 9 at 5. According to the policy, smoking was permitted only in designated smoking areas, and not in resident rooms or inside the facility. Id.  The policy provided that residents who smoke would be categorized into groups based on a smoking assessment.5 Id.  According to the policy, “[t]he Smoker Safety Assessment will be completed by the Unit Manager or Social Worker upon Admission and when a Significant Change in status has been determined.” Id. at 6. The policy further noted that “[t]he Interdisciplinary team will review the Smoker Safety Assessment and determine if the resident is safe to smoke without supervision.” Id. The form also states that “[t]he Interdisciplinary team will determine, based on the Smoker Safety Assessment, which residents will fall into which level and what safety requirements need to be in place at the time of smoking.” Id. As relevant

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here, the policy defined smoking group Level 3 as “Independent smoker with cigarettes to be lit by staff.” Id. at 5. However, the policy also provided that “[f]or those residents that are deemed to be supervised smokers (level 3), staff will assist to designated area at specific times designated for the resident.”6 Id.

Facts related to Resident 3:7

Medical History. I find the following facts by a preponderance of the evidence. At the time of the incidents at issue, Resident 3 was a 69-year-old male who had been admitted to Petitioner’s facility on August 19, 2011. CMS Ex. 5 at 1. On admission, Resident 3’s diagnoses included schizophrenia, bipolar disorder, hypertension (HTN), chronic obstructive pulmonary disease (COPD), low thyroid, seizure disorder, hyperglycemia, and senile dementia. P. Ex. 7 at 1. Similarly, a Care Area Assessment, with an assessment reference date of November 4, 2014, and signed by the Interdisciplinary Care team (IDCT) on November 13, 2014, documented that Resident 3’s diagnoses included bipolar disorder, schizophrenia, anxiety, seizures, dementia, hypothyroidism, hypertension, COPD, and depression. P. Ex. 7a at 103-04. The assessment further noted that Resident 3’s communication was “[h]ighly impaired due to [diagnosis] of dementia.” Id. at 103. With respect to activities of daily living (ADLs), Resident 3 was noted to be at risk for ADL decline related to diagnosis, cognitive impairment, behavioral issues, mood issues, history of fall, and medications. Id. Resident 3 was noted to “[a]mbulate [with] supervision.” Id.

Fall risk assessments for Resident 3, completed on February 3, 2014; May 6, 2014; August 14, 2014; and November 13, 2014, documented three high-risk scores of “12” and one borderline high risk score of “10.” P. Ex. 9 at 2 (“Total score above 10 represents HIGH RISK”). A fall risk assessment completed February 4, 2015, documented a total score of “8.” Id. at 1. Resident 3’s February 2015 fall risk score was lower than his previous scores, in part because the form recorded that he had had no falls in the past three months. Id. Resident 3’s fall risk assessment completed August 14, 2014, similarly

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noted no falls during the three months previous to that assessment. P. Ex. 9 at 2. However, the total score for August 14, 2014, was “10.” Id.

It appears that the February 2015 assessment resulted in the lower score of “8” because staff recorded that Resident 3 was “regularly continent” (score of “0”) while the August 2014 assessment recorded that he “regularly require[d] assistance with elimination” (score of “2”). Compare P. Ex. 9 at 1 with id. at 2. However, there is no indication elsewhere in Resident 3’s medical records that his elimination status had improved to the point that he was no longer occasionally incontinent. See, e.g., CMS Ex. 5 at 7 (Daily Sub-Acute Note for February 2, 2015, documents that Resident 3 is incontinent “at times”); see also CMS Ex. 5 at 33 (care plan for “occasional” incontinence recertified February 12, 2015); CMS Ex. 9 at 9 (Care Area Assessment dated February 4, 2015, indicating occasional incontinence of bladder and bowel). I therefore infer that Resident 3’s fall risk assessment score for February 4, 2015, should have been “10” as was the case with the August 2014 score. Because I interpret a score of “10” on the fall risk assessment as a borderline high risk score, I infer that Resident 3 remained at risk for falls during February 2015, even though he had not experienced a fall during the prior three months. My finding that Resident 3 remained at risk for falls through February 2015 is reinforced by the fact that Petitioner’s IDCT endorsed continuing with Resident 3’s Fall Risk Care Plan on February 12, 2015. CMS Ex. 5 at 24; CMS Ex. 9 at 11; see also Tr. at 164 (date on the care plan “shows that the care plan was revised and was reviewed at that time, . . . that the care plan team, had taken a look at this particular area and felt that the resident was still at risk for falls. So the care plan remained in place along with the interventions.”).

In addition to the Fall Risk Care Plan, Petitioner’s IDCT completed care plans for a number of other areas of concern for Resident 3. For example, Petitioner’s care plan for cognition/communication documents that Resident 3 experienced forgetfulness, depression, and anxiety related to his diagnoses of schizoaffective disorder and bipolar disorder. CMS Ex. 5 at 34. One approach Petitioner planned to meet Resident 3’s needs and keep him safe was to “[k]now [Resident 3’s] whereabouts at all times.” Id. As was true of the Fall Risk Care Plan, the IDCT reviewed and endorsed the care plan for cognition/communication on February 12, 2015. Id.  Similarly, Petitioner’s IDCT reviewed Resident 3’s Schizophrenia/Bipolar Care Plan on February 12, 2015. CMS Ex. 5 at 35. The Schizophrenia/Bipolar Care Plan documented that Resident 3 exhibited altered thought processes, as evidenced by increased anxiety and decreased safety awareness. Id.

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A Care Area Assessment8 with an assessment reference date of February 4, 2015, signed by the IDCT on February 12, 2015, indicates that Resident 3’s diagnoses included bipolar disorder, schizophrenia, anxiety, seizures, dementia, hypothyroidism, hypertension, chronic obstructive pulmonary disease, and depression. P. Ex. 7a at 105.9 Under cognition, Resident 3 was noted to be alert and oriented “x’s 2-3” with BIMS of 13.10 Id. The form further documents that Resident 3’s communication was “[h]ighly impaired due to [diagnosis] of dementia.” Id. With respect to his ADL functioning, Resident 3 was noted to be at risk for ADL decline related to diagnosis, cognitive impairment, behavioral issues, mood issues, history of fall, and medications. Id. Notably, a box for fall history (“Hx fall”) was checked off. Id.; see also Tr. at 162. Under assistive device, Resident 3 was noted to “[a]mbulate [with] supervision.”11 P. Ex. 7a at 105. Under falls, Resident 3 was noted to be at risk for falls related to poor mobility, diagnosis, medications, and unsteady balance. CMS Ex. 9 at 10. Under comments, Resident 3 was noted to have a

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short attention span and that Resident 3’s “major concern” was “when is he due for his next cigarette and who is going to light it for him.” CMS Ex. 9 at 11; P. Ex. 7a at 106.

Resident 3 was a chronic smoker. See, e.g., P. Ex. 11 at 23-25; P. Ex. 8 at 3. The November 2014 Care Area Assessment noted in the “Comments” section that Resident 3 was on a “smoking schedule [with] monitoring by staff.” P. Ex. 7a at 104. Petitioner’s IDCT completed a Smoking Care Plan for Resident 3. CMS Ex. 5 at 38. Resident 3’s Smoking Care Plan documented that Resident 3 had the potential to suffer injury as a result of smoking. Id.  Resident 3’s risk of injury is further underscored by an incident that occurred on November 4, 2014. CMS Ex. 5 at 12.12 At that time, a Licensed Practical Nurse (LPN) documented that Resident 3 “accidentally set pant leg on fire while smoking outside no injury noted.” Id. After the incident, Resident 3 was placed on supervised smoking.13 CMS Ex. 6 at 12.

A Social Service Progress Note, dated February 4, 2015, describes an IDCT discussion concerning Resident 3’s smoking privileges:

During behavioral rounds, [Social Worker] and IDCT discussed re-assessing resident smoking and smoking safety. Resident [3] has had 0 episodes of falling or safety issues since [incident of November 4, 2014]. [Social Worker] assisted him during smoking times to assess smoking safety. [Social Worker] asked [R]esident [3] to demonstrate how to safely hold cigarette, how to safely ash and how to safely put out cigarette. [Social Worker] proceeded to ask [R]esident [3] how to safely get up and walk back into building. Resident [3] demonstrated all tasks safely and several times. Smoking assessment completed and reviewed with [R]esident [3]. Resident [3] agreed and signed. Please see smoking assessment for details.

P. Ex. 11 at 10; CMS Ex. 5 at 13. Also on February 4, 2015, Resident 3 signed a Smoker Safety Assessment form which documented that Resident 3 was alert and oriented, would ask repetitive questions, and was ambulatory. CMS Ex. 9 at 1-2. Under the smoking history, the form indicates that Resident 3 smoked eight times per day, needed assistance

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to smoke, and could not light a cigarette. Id. at 1. In the area of special needs, Resident 3 required a smoking apron, and staff was to keep all supplies, and light all cigarettes. Id. The required level of supervision was indicated at “Level 3 – Independent after smoke lit by staff.” CMS Ex. 9 at 2. Also on February 4, 2015, Resident 3 signed a copy of Petitioner’s Smoking Program policy. CMS Ex. 9 at 5-6.14

On February 12, 2015, a mental health nurse practitioner evaluated Resident 3 and recommended “smoking safety checks by staff upon return from smoke breaks.” P. Ex. 6 at 1. Although the record does not show that Petitioner modified Resident 3’s Smoking Care Plan to reflect the nurse practitioner’s recommendation, her recommendation is consistent with the documented approach to “observe clothin[g] and skin for burns.” See CMS Ex. 5 at 38.

Events of March 3-4, 2015. At or about 8:30 p.m. on March 3, 2015, LPN 115 gave Resident 3 a cigarette. CMS Ex. 4 at 7, 12, 13. Certified Nursing Assistant (CNA) 7 took Resident 3 outside, lit the cigarette, and left Resident 3 outside alone, so he could smoke. Id.; see also CMS Ex. 1 at 12; CMS Ex. 3 ¶ 4. On March 3, 2015, at 8:30 p.m., the outside temperature was 33.1° Fahrenheit (F), the wind chill was 28.7° F, and precipitation of 0.54 inches rain/snow occurred. CMS Ex. 3 ¶ 17.

At or about 10:00 p.m. on March 3, 2015, LPN 1 noted Resident 3 to be missing and initiated a room search. CMS Ex. 4 at 7, 12. At or about 10:15 p.m., LPN 1 notified her supervisor, a Registered Nurse (RN 1), that Resident 3 was missing, and a search of the building and premises was initiated. CMS Ex. 4 at 7-8, 12, 15-23, 25.

As documented in an Accident/Incident Investigation report completed by Petitioner’s staff, two CNAs were directed to search outside, one of whom went to a nearby coffee shop to see if Resident 3 had gone there; Resident 3 was not found. CMS Ex. 4 at 11, 13.

At or about 10:45 p.m. on March 3, 2015, RN 1 notified the Director of Nursing (DON) that Resident 3 was missing; the Administrator was also notified. CMS Ex. 4 at 7-8.

At approximately 11:00 p.m. on March 3, 2015, Petitioner’s staff called police. Incident reports created by facility staff note that police were called at 10:50 p.m. Id. at 7, 11. On the other hand, the police report documents that the incident was reported at 11:01 p.m. (23:01:03). CMS Ex. 7 at 2. I do not find the difference between 10:50 p.m. and 11:01 p.m. material to my decision.

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Upon arriving at the facility, police officers initiated a room-to-room search of Petitioner’s building but did not locate Resident 3. CMS Ex. 7 at 4. The officers then conducted a perimeter search. Id.  At approximately 12:02 a.m., an officer located Resident 3 on the grounds of an abandoned firehouse across the street from the facility. Id.; see also CMS Ex. 4 at 7. In a telephone interview conducted as part of the survey, a police detective stated that officers located Resident 3 by following “tracks in the snow” to the abandoned firehouse. CMS Ex. 6 at 32; see also CMS Ex. 1 at 25. When found, Resident 3 “was laying face down on the ground without clothing” and “appeared to have shallow breathing and was making a groaning noise.” CMS Ex. 7 at 4. Resident 3 went into cardiac arrest at approximately 12:11 a.m. Id. Officers administered CPR and four AED (automatic external defibrillator) shocks before turning Resident 3’s care over to Emergency Medical Services and the fire department. Id. Paramedics arrived at approximately 12:20 a.m., and Resident 3 was transported to the hospital at approximately 12:33 a.m. Id.

In the hospital Emergency Department, Resident 3 was assessed as having ventricular fibrillation associated with hypothermia. CMS Ex. 8 at 11. Resident 3 died at the hospital at 2:45 a.m. on March 4, 2015. Id. at 6, 19, 21. The cause of death listed was cardiac arrest. Id. at 6.

As part of her investigation, the surveyor viewed video footage from Petitioner’s security system depicting the interior of Petitioner’s facility on the evening of March 3, 2015. See, e.g., CMS Ex. 6 at 22. The video confirmed that Resident 3 did not return inside the facility after 8:30 p.m. Id.; see also CMS Ex. 1 at 13-15. The video recording also revealed that the doors at Petitioner’s main entrance (Beechwood Avenue) remained unlocked from the time the receptionist left the building (time marker 20:3916 on the video recording) until after police officers entered the building (time marker 23:57 on the video recording). Id. at 15‑16; see also CMS Ex. 6 at 50.

The surveyor also observed the grounds surrounding Petitioner’s facility. See, e.g., CMS Ex. 6 at 9, 15. She noted that there was a winding concrete path or walkway from the smoking area outside Petitioner’s facility. Id. at 15. While following that walkway in the direction of the abandoned firehouse where Resident 3 was discovered, the surveyor noted a steep decline, filled with trees and branches to the left of the path. Id.  According to her observation, there was no fence around the low-lying area. Id.  The surveyor additionally noted that the perimeter of the property was fenced but the fence was “open by the fire house” and there was no gate. Id.

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Analysis:

As I explain in this section of my decision, I find, based on the record as a whole, that Petitioner did not take all reasonable steps to ensure that Resident 3 received adequate supervision to prevent accidents. Petitioner’s own assessments document that Resident 3 was cognitively impaired and at risk for falls and, for those reasons, required supervision, including a care-planned intervention that required staff to know his whereabouts at all times. See CMS Ex. 5 at 34. Nevertheless, beginning shortly after 8:30 p.m. on March 3, 2015, when a staff member lit Resident 3’s cigarette and left him outside to smoke, no member of Petitioner’s staff was aware of Resident 3’s whereabouts, in disregard of his care plan. Moreover, staff did not discover that Resident 3 was missing until about 10:00 p.m. – some 90 minutes later. It is therefore apparent that, on the evening of March 3, 2015, Petitioner did not provide the supervision Resident 3 required, because Petitioner’s staff demonstrably did not know Resident 3’s whereabouts for approximately 90 minutes, during which time he was able to elope from Petitioner’s premises.

Petitioner argues that it substantially complied with 42 C.F.R. § 483.25(h). P. Post-Hr’g Br. at 11. Petitioner relies on two main points to establish that its care of Resident 3 was not deficient. First, Petitioner contends that its staff appropriately assessed Resident 3 as capable of smoking independently. Id. at 4-6. Second, Petitioner argues that Resident 3 was not assessed as an elopement risk, nor did he have a history of wandering; thus, his eloping was unforeseeable. Id. at 6. Petitioner’s arguments miss the mark.

Petitioner devotes the majority of its brief to arguing that its staff acted appropriately in February 2015, when they changed Resident 3’s smoking status from “supervised” to “independent.” According to Petitioner, Resident 3 was having anxiety related to supervised smoking in the months leading up to his elopement, which resulted in his reassessment on February 4, 2015, reclassifying Resident 3 as an independent smoker with cigarette lit by staff. Id.

The issue of whether Resident 3 was independent with smoking or required supervision to smoke safely is tangential, at best. Even if I accept Petitioner’s argument that it was appropriate to classify Resident 3 as an independent smoker as of February 4, 2015, this does not alter the fact that Petitioner itself documented that Resident 3 required supervision in numerous other areas. For example, the February 4, 2015 Care Area Assessment provided that Resident 3 needed supervision while ambulating, had poor mobility, unsteady balance, a short attention span, and was at risk for ADL decline. P. Ex. 7a at 105. Moreover, Daily Sub-Acute Notes generated on February 2, 3, and 4, 2015, confirmed that Resident 3 needed supervision with all and assistance with some ADLs. CMS Ex. 5 at 6-11 (per check box in upper right corner of forms). Further, Resident 3’s care plans document that Resident 3 was at risk for falls, that Petitioner’s staff were required to know Resident 3’s whereabouts at all times (CMS Ex. 5 at 34) on account of his cognitive impairment (also decreased safety awareness (CMS Ex. 5

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at 35)), and that staff were to inspect his clothing and skin for burns (CMS Ex. 5 at 38), which was recommended to occur each time he returned from smoking (P. Ex. 6 at 1). I cannot conclude that Petitioner satisfied its duty to adequately supervise Resident 3 on March 3, 2015, when staff left him outside to smoke and no one verified that he had come inside or that he had not burned his clothing or skin while smoking. Had Petitioner’s staff attempted even this most basic level of supervision, they would have discovered, at a minimum, that Resident 3 was missing before 90 minutes had elapsed. Had Petitioner done so, there would perhaps have been time to locate Resident 3 before he suffered irreversible hypothermia.

Petitioner’s second argument – that Resident 3 had no history of wandering17 and had not been assessed as an elopement risk – fails for the same reasons just discussed. Even if Resident 3 had never attempted to elope prior to March 3, 2015, Petitioner did not implement even the level of supervision it had determined was appropriate for Resident 3’s needs, based on its assessment of the behaviors and diagnoses of which it was aware.

In summary, Petitioner did not take all reasonable steps to supervise Resident 3 and thereby protect him from accident hazards. Given the weather conditions, the longer Resident 3 remained outdoors, the greater his risk of becoming disoriented and hypothermic, as in fact occurred. In addition, once Resident 3 left the smoking area, he risked falling even before he left Petitioner’s property, based on the uneven ground the surveyor observed. See CMS Ex. 6 at 9, 15. Finally, Petitioner’s failure to follow its door-locking policy had the potential to affect any of its residents who may have been elopement risks. Petitioner’s noncompliance was substantial in that it resulted in more than minimal harm to Resident 3, who eloped from Petitioner’s facility and died as a result. In addition, had any other of Petitioner’s residents eloped through its unlocked entrance, they would similarly have been at risk of more than minimal harm on that cold March night. Therefore, I conclude that Petitioner was not in substantial compliance with section 483.25(h) (Tag F323) as of March 3, 2015.

3. CMS’s immediate jeopardy determination was not clearly erroneous.

CMS asserts that Petitioner’s noncompliance with 42 C.F.R. § 483.25(h) (Tag F323) posed immediate jeopardy to resident health and safety at the “L” scope and severity level from March 3, 2015 through March 11, 2015. CMS Pre-Hr’g Br. at 1, 3; CMS Post-Hr’g Br. at 18. Petitioner argues that the finding of immediate jeopardy was clearly erroneous. P. Pre-Hr’g Br. at 23-24; P. Post-Hr’g Br. at 12-14.

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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. I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The “clearly erroneous” standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy. Appellate panels of the DAB have sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)), aff’d, Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs., 174 F. App’x 932 (6th Cir. 2006).

In this case, CMS’s finding of immediate jeopardy is not clearly erroneous. There is no doubt that Resident 3 was at risk of serious injury, harm, impairment or death when Petitioner’s staff failed to discover that he had not returned from a smoke break shortly after 8:30 p.m. on March 3, 2015. Because of the freezing cold temperatures and the fact that Resident 3 was already missing for 90 minutes before he was noted missing at 10:00 p.m., Resident 3 faced a foreseeable risk of hypothermia and death. In addition, given his cognitive impairment, dementia, seizure disorder, bipolar disorder, schizophrenia, and fall history, Resident 3 faced other foreseeable risks of harm (such as injuries from various causes, anxiety from unfamiliar surroundings, etc.). Resident 3 also had poor safety awareness and diminished capacity to help himself if he was physically injured while away from the facility. Given all the risk factors involved, there was immediacy, because time was of the essence. Moreover, Petitioner’s failure to ensure that the main lobby door to the facility was consistently kept externally locked after 8:00 p.m., contributed to resident risk for serious harm or potential injury.18

Petitioner claims that Resident 3’s elopement was a “tragic and unforeseen event.” P. Post-Hr’g Br. at 6. I agree that Resident 3’s death was “tragic,” and it is clear, as a matter of fact, that Petitioner did not foresee it. This does not mean that Resident 3’s elopement was unforeseeable in the legal sense, however. To the contrary, it is certainly foreseeable that a cognitively impaired resident, left outdoors on a freezing cold night, might suffer injury, whether or not he left Petitioner’s premises. As I have concluded above, Petitioner did not take all reasonable steps to mitigate the risks of serious harm to Resident 3. Petitioner’s failure to provide Resident 3 adequate supervision on March 3, 2015, resulted in foreseeable, serious harm to Resident 3’s health and safety, which ultimately led to his death. I therefore conclude that CMS did not clearly err in finding that Petitioner’s noncompliance constituted immediate jeopardy.

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4. The remedy proposed is reasonable in amount and duration.

Regarding the amount of the CMP, I examine whether a CMP is reasonable by applying 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) the 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 listed in § 488.404 include: 1) the scope and severity of the deficiency; 2) the 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. Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it. Coquina Ctr., DAB No. 1860 at 32 (2002).

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of a CMP, $50 to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). In assessing the reasonableness of a CMP amount, an administrative law judge looks at the per-day amount, rather than the total accrued CMP. See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008). The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range. 42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29.

For March 3, 2015 through March 11, 2015, the period during which CMS alleges that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety, CMS proposed a CMP of $8,800 per day, which is in the middle-to-high range for immediate jeopardy level noncompliance. CMS argues generally that the proposed CMP is reasonable for the “immediate jeopardy deficiency with facility culpability and a resident death.” CMS Post-Hr’g Br. at 18; see also CMS Pre-Hr’g Br. at 21. Petitioner contends the CMP is clearly erroneous, because there is no evidence in the record supporting the immediate jeopardy finding. P. Pre-Hr’g Br. at 24. Petitioner also points out that Resident 3 “was subject to actual harm as a result of unforeseen circumstances resulting from an unforeseeable elopement.” P. Pre-Hr’g Br. at 24; see also Post-Hr’g Br. at 14. Petitioner simply contends the deficiency cited and the associated CMP should be removed. P. Post-Hr’g Br. at 14. I reject this argument. For the reasons discussed in the

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previous sections of this decision, I have determined that Petitioner did not comply substantially with Medicare participation requirements and that CMS did not clearly err in finding the deficiency represented immediate jeopardy to resident health and safety.

Petitioner does not specifically argue that any particular regulatory factor supports a reduction of the CMP amount proposed by CMS. For that reason alone, I could conclude the CMP is reasonable in amount and duration. See Coquina Ctr., DAB No. 1860 at 32. Even considering the factors de novo, however, I conclude that a CMP of $8,800 per day for the period of Petitioner’s immediate jeopardy noncompliance is reasonable. CMS did not argue that Petitioner had a history of noncompliance, nor did Petitioner submit evidence concerning its financial condition. Accordingly I do not consider factors (f)(1) and (f)(2). However, Petitioner’s immediate jeopardy noncompliance was very serious, implicating factor (f)(3), and Petitioner’s actions as a whole indicate, at a minimum, that it was neglectful or indifferent to Resident 3’s care and safety, implicating factor (f)(4).

Petitioner left Resident 3 outside to smoke on a freezing cold night, which resulted in the resident’s elopement and ultimate death. Petitioner failed to observe that Resident 3 did not return inside the facility after smoking, which enabled him to wander away undetected. Furthermore, Petitioner’s failure to lock its doors in accordance with its policy and New Jersey regulations could have allowed other residents to elope, leading to similar harm to those residents. Consequently, I agree with CMS that Petitioner’s culpability and the scope and severity of Petitioner’s noncompliance justify a CMP in the middle-to-high range for immediate jeopardy noncompliance. I therefore conclude that the $8,800 CMP is reasonable.

In regards to the duration of the imposed CMP, 42 C.F.R. § 488.454(a) provides in pertinent part that a CMP “continue[s] until . . . [t]he facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit.” Once CMS demonstrates that a facility is out of substantial compliance, the burden shifts to the facility to demonstrate its return to substantial compliance. Premier Living & Rehab. Ctr., DAB No. 2146 at 23 (2008). “Under the regulations, the mere submission of a [plan of removal] d[oes] not establish that any cited deficiencies had been corrected.” Hermina Traeye Mem’l Nursing Home, DAB No. 1810 at 13 (2002).

CMS determined that Petitioner was out of substantial compliance at the immediate jeopardy level for nine days, from March 3, 2015 through March 11, 2015. I have already concluded that Petitioner was not in substantial compliance with the regulation at 42 C.F.R. § 483.25(h) (Tag F323), and that noncompliance started as early as March 3, 2015. Petitioner therefore bears the burden of showing that it achieved substantial compliance prior to March 12, 2015, the date CMS determined Petitioner returned to substantial compliance. See Premier Living, DAB No. 2146 at 23. Petitioner failed to present any argument that it returned to substantial compliance prior to March 12, 2015.

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Consequently, I conclude that the CMP proposed by CMS is reasonable both in amount and in duration.

V. Conclusion

For the reasons set forth above, I conclude that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. § 483.25(h) (Tag F323). I further conclude that CMS did not clearly err in determining that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety. Finally, I conclude that a CMP of $8,800.00 per day for nine days of immediate jeopardy, from March 3, 2015 through March 11, 2015, a total CMP of $79,200, is reasonable.

• 1. In a final rule promulgated October 4, 2016, and effective November 28, 2016, CMS issued comprehensive revisions to the regulations governing Medicare participation requirements for long term care facilities.  81 Fed. Reg. 68,688 (Oct. 4, 2016).  As part of that revision, the former 42 C.F.R. § 483.25(h) was redesignated, without revision, as 42 C.F.R. § 483.25(d).  Based on the date of the survey in this case, which preceded the regulatory revisions, I refer to the regulations that were in effect at the time of the survey.  See Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey).
• 2. The surveyors also cited noncompliance at a level below immediate jeopardy with the Medicare program participation requirements at 42 C.F.R. § 483.20(g)-(j) (Tag F278).  CMS Ex. 1 at 1-2.  As explained in note 3, below, that deficiency is not at issue in this case.
• 3. Petitioner has not challenged the finding of substantial noncompliance with the regulation at 42 C.F.R. § 483.20(g)-(j) (Tag F278), cited at a level below immediate jeopardy.
• 4. My conclusions of law appear as numbered headings in bold italic type.  My findings of fact appear in the supporting text.
• 5. Although the Smoking Program policy states that “all patients and residents will be categorized into 1 of 3 different smoking groups,” 4 smoking groups are listed, from “Level 1” through “Level 4.”  CMS Ex. 9 at 5.
• 6. It is apparent that the Smoking Program policy was internally inconsistent.  The policy indicated that there were three smoking levels, but listed four.  CMS Ex. 9 at 5.  In addition, the policy described the Level 3 smoking group as both independent and supervised.  Id.  While the survey was in progress, on March 10, 2015, Petitioner’s Director of Nursing provided a “corrected copy” of the policy to the surveyor.  Tr. 113‑14, 156-58; see CMS Ex. 11 at 3-4.  The “corrected copy” provides that “supervised smokers” are those categorized as “level 4.”  CMS Ex. 11 at 3.  The statement that there are three smoking groups (rather than four) was not corrected.  Id.
• 7. To protect the resident’s privacy and that of his family, I refer to him by the numerical identifier assigned during the survey.
• 8. The survey concluded that a Minimum Data Set (MDS) dated February 4, 2015 (see CMS Ex. 10), was not properly reflective of the February 4, 2015 Care Area Assessment, resulting in a deficiency at 42 C.F.R. § 483.20(d) (Tag F278).  Tr. at 56-57, 160-62; see also CMS Ex. 1 at 1-5.  Petitioner did not appeal the deficiency finding at Tag F278.  Petitioner, therefore, has conceded that the February 4, 2015 MDS was inaccurate.  For that reason, I accord no weight to the assessments of Resident 3 reflected in the February 4, 2015 MDS.  For example, I do not find that Resident 3 was independent in ADLs or ambulation.  Ms. Lebak testified credibly at the hearing that the February 4, 2015 Care Area Assessment represented Resident 3’s “true abilities.”  Tr. at 99-100.
• 9. The February 4, 2015 Care Area Assessment is also in evidence as CMS Ex. 9 at 9-11.  However, in P. Ex. 7a, Resident 3’s name has been redacted.
• 10. BIMS” is an acronym for Brief Interview for Mental Status.  BIMS scores are categorized into 3 levels:  intact/borderline cognition (13–15), moderate cognitive impairment (8–12), and severe cognitive impairment (0–7).  See, e.g., Kali S. Thomas et al., The Minimum Data Set 3.0 Cognitive Function Scale, 55 Med. Care e68 (2017) (online article), available at https://insights.ovid.com/crossref?an=00005650-201709000-00011 (last visited Oct. 25, 2019).  Thus, Resident 3’s BIMS score of 13 as of February 2015 indicates borderline intact cognition.  However, I note that, in a Care Area Assessment with an assessment reference date of February 22, 2013 (P. Ex. 7 at 134), Resident 3 was assessed with a BIMS score of 9, which falls in the moderately impaired range.  I infer from this that Resident 3’s cognitive abilities fluctuated over time.
• 11. At the hearing, Ms. Lebak testified that the phrase “ambulate with supervision” means that “someone needs to be watching [Resident 3] 24/7.”  Tr. 122-23.
• 12. The document in evidence does not include the year.  However, based on the other evidence in the record, I find that the incident took place on November 4, 2014.
• 13. According to Petitioner’s Smoking Program policy, cigarettes for supervised smokers were held at the nurses’ station and staff escorted smokers outside to smoke at specific, predetermined times.  See CMS Ex. 9 at 5.
• 14. The version of the policy that Resident 3 signed does not include the language from the “corrected copy” of the policy described above at note 6.  See CMS Ex. 9 at 5.
• 15. I refer to Petitioner’s staff by the numerical identifiers assigned during the survey.
• 16. One of Petitioner’s employees told the surveyor that the time imprint on the video recording did not reflect the accurate time, but was approximately 48 minutes ahead of the correct time.  CMS Ex. 1 at 14; CMS Ex. 6 at 22.  Adjusting for this, the receptionist would have left the building a little before 8:00 p.m. and the officers would have entered at about 11:10 p.m.
• 17. It is not clear to me that Resident 3 had no history of wandering.  Surveyor notes of a staff interview record that RN 2 reported Resident 3 would wander into other residents’ rooms and take things.  CMS Ex. 6 at 20.  I agree, however, that the record before me does not include any evidence that Resident 3 had ever wandered away from Petitioner’s facility prior to March 3, 2015.
• 18. According to the New Jersey State Standards for Licensure of Long Term Care Facilities, N.J. Admin. Code § 8:39-31.8(b), “all exit doors to the facility shall be kept externally locked from 8:00 p.m. to 6:30 a.m.”  See also CMS Ex. 3 ¶ 5.