Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Springfield Nursing & Independent Living,
(CCN: 36-6099),
Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-23-601
Decision No. CR6760
DECISION
Petitioner, Springfield Nursing & Independent Living, is a long-term care facility, located in Springfield, Ohio, that participates in the Medicare program. When one of its wheel-chair-bound residents – at high-risk for elopement – was left unattended, he departed the facility through an unsecured and unmonitored door. He lost control of his wheelchair, fell down a steep set of concrete steps, and suffered massive injuries, from which he later died.
The Centers for Medicare & Medicaid Services (CMS) subsequently determined that the facility was not in substantial compliance with Medicare program requirements, including 42 C.F.R. § 483.25(d) (accident prevention), and that the deficiency cited under that regulation posed immediate jeopardy to resident health and safety. Based on this and other deficiencies, CMS imposed remedies: a $7,320 per-day civil money penalty (CMP) for 11 days of immediate jeopardy and a $245 per-day CMP for 20 days of substantial noncompliance that did not pose immediate jeopardy.
Petitioner limits this appeal to the deficiency cited under section 483.25(d), and the parties agree that this case may be decided based on the written record.
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For the reasons set forth below, I find that the facility was not in substantial compliance with Medicare program requirements 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).
In this case, a surveyor from the Ohio Department of Health (state agency) went to the facility to investigate a resident's elopement and fatal injury. See CMS Ex. 24; CMS Ex. 29 at 1-3. The surveyor completed her complaint investigation survey on January 13, 2023. CMS Ex. 2; CMS Ex. 30 at 1 (Sherman Decl. ¶ 2). Based on the survey findings, CMS determined that the facility was not in substantial compliance with the following Medicare participation requirements:
- 42 C.F.R. § 483.10(g) (Tag F580 – resident rights: notification of changes), cited at scope-and-severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
- 42 C.F.R. § 483.25(d) (Tag F689 – quality of care: accident prevention), cited at scope-and-severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety); and
- 42 C.F.R. § 483.50(a)(1)(iv) (Tag F772 – laboratory services), cited at scope-and-severity level D.
CMS Exs. 2, 4, 5, 7.
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Thereafter, CMS determined that the facility returned to substantial compliance on January 18, 2023. CMS Ex. 7 at 2.
CMS has imposed against the facility a CMP of $7,320 per day for 11 days of immediate jeopardy (December 18 through December 28, 2022) and $245 per day for 20 days of substantial noncompliance that did not pose immediate jeopardy (December 29, 2022, through January 17, 2023) (Total: $80,520 + $4,900 = $85,420). CMS Ex. 7 at 2.
Petitioner appeals. The parties agree that this case may be decided based on the written record. Joint Stipulation Regarding a Decision on the Written Record (DAB E-file # 14).1
CMS has filed a motion for summary judgment and pre-hearing brief (CMS Br.), along with 40 exhibits (CMS Exs. 1-40). Petitioner filed its own pre-hearing brief (P. Br.), with four exhibits (P. Exs. 1-4). In the absence of any objections, I admit into evidence CMS Exs. 1-40 and P. Exs. 1-4.
ISSUES
The parties have agreed to limit the issues. The issues before me are:
- From December 18, 2022, through January 17, 2023, was the facility in substantial compliance with 42 C.F.R. § 483.25(d);
- If, from December 18 through December 28, 2022, the facility was not in substantial compliance with section 483.25(d), did that deficiency then pose immediate jeopardy to resident health and safety; and
- Is the penalty imposed for the period of immediate jeopardy – $7,320 per day – reasonable?
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Joint Stipulation to Limit Issues (DAB E-file # 4).
Based on the deficiencies that Petitioner has not appealed, I find that, from December 18, 2022, through January 17, 2023, the facility was not in substantial compliance with Medicare program requirements and that the $245 per-day CMP – imposed for the 20 days of substantial noncompliance that did not pose immediate jeopardy – is reasonable.
DISCUSSION
- The facility was not in substantial compliance with 42 C.F.R. § 483.25(d) because the resident environment was not free of accident hazards and because the facility did not ensure that a vulnerable resident received adequate supervision and assistive devices to prevent accidents.2
Program requirement: 42 C.F.R. § 483.25(d) (Tag F689). Quality of care "is a fundamental principle that applies to all treatment and care provided to facility residents." 42 C.F.R. § 483.25.
The statute and regulation require that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the 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)(2); 42 C.F.R. § 483.25.
To this end, the "quality of care" regulation mandates, among other requirements, that the facility "ensure" that each resident's environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistive devices to prevent accidents. 42 C.F.R. § 483.25(d). The facility must 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 sub nom. 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 that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents."). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an "adequate" level of supervision under all the circumstances. 42 C.F.R. § 483.25(d); Liberty Commons Nursing & Rehab – Alamance, DAB No. 2070 at 3 (2007), aff'd sub nom. Liberty Commons Nursing & Rehab Ctr. – Alamance v. Leavitt, 285 F. App'x 37
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(4th Cir. 2008); 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). The issue is not whether the facility took "some steps" to mitigate an assessed risk; the issue is whether the facility took "all reasonable steps." Logan Healthcare Leasing, LLC, DAB No. 3036 at 15 (2021).
Where a facility policy requires staff to take specific measures in caring for a resident, those measures reflect the facility's own determination of what it must do to attain or maintain the resident's "‘highest practicable physical, mental, and psychosocial well-being' as required by the overarching quality-of-care requirement." Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017) (quoting Azalea Court, DAB No. 2352 at 9 (2010)); Emery Cnty. Care & Rehab. Ctr., DAB No. 3006 at 11 (2020). The facility is not in substantial compliance with section 483.25(d) if, without justifiable reason, it does not implement the accident precautions that its staff have determined are necessary to mitigate foreseeable accident risks. Heritage House of Marshall Health & Rehab., DAB No. 3035 at 10-11 (2021); Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 14 (2018); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013).
Facility Policy: Elopement/Unauthorized Absence. The facility had in place a policy to identify residents at risk for elopement and to protect those residents by developing and implementing safety interventions. The policy includes procedures for promptly locating a resident who has eloped. CMS Ex. 34 at 1.
According to the policy, elopement "occurs when a resident leaves the premises or a safe area without authorization (i.e., an order for discharge or leave of absence) and/or" necessary supervision. Id.
The policy requires that, at the time of admission, quarterly, and as needed, all residents be assessed for the risk of elopement, using the "Saber Elopement Assessment." If the elopement score is 4 or higher, the resident is identified as "at risk for elopement." For a resident identified as at risk for elopement, the facility must promptly implement interventions to reduce that risk. It will notify the resident's physician and inform the resident's responsible party of the risk and recommended interventions. At-risk residents' pictures and face sheets or demographic forms will be placed in a binder that is kept in an area accessible by staff. Id.
The policy outlines procedures for responding to an elopement, which include: announcing that a resident is missing (using a code); notifying the appropriate individuals (the Administrator, the Director of Nursing (DON), and the attending physician); searching the premises; expanding the search, as necessary; and notifying law enforcement, as necessary. When the resident is located, staff must: examine the resident and record the findings in the chart; notify family/legal representative and attending physician; administer any missed or late medications per physician order and as
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needed, based on the resident's physical assessment; and initiate prompt interventions to prevent further exit-seeking. CMS Ex. 34 at 1-2.
Facility Policy: Secured Resident Unit. The facility had a secured resident unit as the least restrictive environment for those residents "whose quality of life is improved by maintaining freedom of movement within a secure environment." CMS Ex. 35. A resident is not placed on a secure unit for the convenience of staff or as a means of involuntary seclusion. A resident may also choose to reside on the secure unit to be closer to a loved one. Id.
The policy requires that the resident or legal representative and the interdisciplinary team periodically discuss prospective and ongoing placement on a secure unit, taking into consideration:
- The wishes of the resident and/or representative.
- Alternatives, documenting the discussion.
- The reasonableness of placement on the secure unit, including the resident response and reaction to prospective or actual placement, documenting the discussion.
- Before placement on the secure unit, and at least quarterly after placement, staff will conduct an ongoing, periodic assessment/evaluation of the resident and the benefits and risks of the placement. The evaluation includes: whether less restrictive alternatives have been unsuccessful in preventing safety risks for the resident and others and whether the resident habitually wanders without the capacity to return, presenting a danger to self.
- The resident's comprehensive care plan is updated as to goals of placement, such as: preventing social isolation or socialization; enhancing safety; and maintaining or improving the resident's physical or emotional functioning.
- The resident/responsible party must sign consent prior to or upon admission to the secure unit.
- The facility will obtain a provider order for the resident to reside on the secure unit.
Id.
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The Facility's Layout. The facility had three floors of resident rooms plus a basement. CMS Ex. 30 at 3 (Sherman Decl. ¶ 8). An assisted-living unit was on the second floor, and the nursing facility was on the first. The first floor had two wings: East and West. The East Wing was unsecured; the West Wing was the secured unit. CMS Ex. 27; CMS Ex. 30 at 3 (Sherman Decl. ¶ 8); CMS Ex. 36 at 1. A nurses' station and a set of doors were at one end of the East Wing hallway. The doors consisted of an interior door, equipped with a magnet alarm, and an exterior door, placed very close to the interior door. The exterior door had no alarm. When closed, it locked automatically. To reenter the facility, individuals on the outside had to ring a doorbell and wait until someone on the inside let them in. CMS Ex. 27; CMS Ex. 29 at 8; CMS Ex. 30 at 3 (Sherman Decl. ¶ 8); CMS Ex. 36.
Outside the East Wing exit doors ("elopement door") was a concrete landing leading to a steep set of concrete steps (approximately 14 steps). CMS Ex. 27; CMS Ex. 30 at 2 (Sherman Decl. ¶ 8). Residents of the assisted-living unit on the second floor often used this door to leave and reenter the facility when they took smoking breaks. CMS Ex. 30 at 3 (Sherman Decl. ¶ 8); see CMS Ex. 29 at 9 (explaining that assisted-living residents would push open the exit door, setting off the alarm, in order to smoke on the outside deck).
A set of double doors – two doors within one framed opening – was at the other end of the first floor East Wing. The set of doors was equipped with a magnet alarm. Outside the doors was a porch area with five concrete steps. CMS Ex. 30 at 3 (Sherman Decl. ¶ 8); CMS Ex. 36 at 1.
The facility's front door was not alarmed and exited to another steep set of concrete steps containing approximately 12 steps. CMS Ex. 30 at 3 (Sherman Decl. ¶ 8).
Resident 60 (R60). R60 was a 73-year-old man, admitted to the facility on November 25, 2022. His legs had been amputated above the knees, and he was wheelchair-dependent. CMS Ex. 15 at 1; CMS Ex. 19 at 1.
He suffered from chronic obstructive pulmonary disease, hypertension, urinary incontinence, nicotine dependence, and visual loss. CMS Ex. 15; CMS Ex. 18 at 4, 5, 22; CMS Ex. 19 at 1. His hearing was impaired. CMS Ex. 18 at 9. His concentration was limited. CMS Ex. 18 at 15. He also suffered from moderately severe depression, and, prior to his admission, an examining physician described R60 as "angry and physically combative." CMS Ex. 14 at 4-5. His BIMS (Brief Interview of Mental Status) score was 4, indicating a severe cognitive impairment. CMS Ex. 19 at 1. Any leave of absence from the facility had to be supervised. CMS Ex. 18 at 16.
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R60 was placed in room 107, on the unsecured East Wing of the facility's first floor. CMS Ex. 15 at 1; CMS Ex. 27; CMS Ex. 30 at 3 (Sherman Decl. ¶ 9); CMS Ex. 36 at 1. He was able to propel his wheelchair on and off the unit. P. Ex. 4 at 3, 6.
R60 was at high risk for falls related to the bilateral amputations. CMS Ex. 18 at 10. And he fell many times:
- On November 27, 2022, he fell while trying to transfer himself from his wheelchair to his bed and suffered a mild abrasion to the back of his head. CMS Ex. 19 at 22; see CMS Ex. 29 at 3.
- A progress note, dated December 1, 2022, indicates that he had a "new onset hematoma" to the head and that his behaviors included disrobing and urinating on the floor and in bed. CMS Ex. 19 at 18.
- On December 11, 2022, a nurse responded to R60's yelling. She found him sitting on the floor beside his bed. His bed was wet, and his urinal was on the bed-side table at the foot of his bed. Staff cleaned him up and transferred him to his wheelchair. Staff were educated to keep his urinal at bedside, within his reach at all times. CMS Ex. 19 at 14. A short note, dated December 12, 2022, indicates that the interdisciplinary team reviewed the incident and that the intervention was to keep the resident's urinal at bedside. CMS Ex. 19 at 11.
- On December 15, 2022, a nurse aide discovered R60 seated on a floormat next to his bed, reaching for his wheelchair. He said that he had wanted to get out of bed. Staff (three-person assist) transferred him to his wheelchair. He was put on one-on-one supervision for the duration of the shift. CMS Ex. 19 at 5.
Exit-seeking behavior. At the time of his admission, R60 had no history of wandering and did not verbalize or exhibit exit-seeking behavior, so the facility identified him as low risk for elopement. CMS Ex. 16. However, that behavior soon changed.
- On December 8, 2022, R60's physician ordered 15-minute checks for exit-seeking. CMS Ex. 17 at 1, 5, 10, 11. Staff thereafter documented the 15-minute checks. CMS Ex. 20; P. Ex. 2. However, the facility did not reassess to determine R60's elopement risk; it did not amend his care plan to address the new behavior.
- In a progress note, entered on December 9, 2022, a nurse describes R60 as "ambulating in a wheelchair[,] exit-seeking." CMS Ex. 19 at 17 (emphasis added). He went to the East Wing door and pushed it open. Staff redirected him, and he "turned around before going out the exit." Id.
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- A progress note entered at 6:47 a.m. on December 10, 2022, describes R60 as "repeatedly exit seeking and disrobing." He urinated directly on the floor twice. CMS Ex. 19 at 16.
- A note entered at 9:28 a.m. that day (December 10) describes R60 opening the exit door by the nurses' station and trying to get out. He asked the nurse when he would be able to get out, and she told him that he had to stay inside and that his wife would visit. Id.
- At 6:03 p.m. on December 11, 2022, staff wrote that R60 is exit-seeking, pushing open doors. The nurse gave him the juice he requested, but he continued to wheel back and forth toward the doors. CMS Ex. 19 at 12-13.
- A progress note entered at 4:11 a.m. on December 12, 2022, describes R60 as "exit seeking X3." CMS Ex. 19 at 12.
A December 12, 2022 progress note from the interdisciplinary team describes a conversation with R60's wife. The facility's DON talked to her about R60's exit-seeking behavior and told her that he was an elopement risk. The DON told R60's wife that the behavior "usually occurs in the evening after [the] wife leaves." CMS Ex. 19 at 10.3 R60's wife said that she preferred the Wanderguard system to putting her husband in a secured unit and would like to transfer R60 to another facility that had the Wanderguard system in place. The note indicates that social services was "aware" and would send in a referral. In the meantime, R60 would remain on 15-minute checks. CMS Ex. 19 at 10.4
On December 12, 2022, staff added "risk of elopement" to R60's care plan. But the interventions listed in the plan are mostly limited to the actions that staff had been trying: 15-minute checks; redirect; divert attention and "relocate resident to a different area." CMS Ex. 18 at 19. "Relocate resident to a different area" is not explained, but if it means
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that R60 should move to a different section of the facility (like the secured unit), that relocation did not happen. CMS Ex. 18 at 19.
Not surprisingly, the listed interventions did not minimize or control R60's exit-seeking behavior. If anything, the behavior intensified, and staff soon recognized that the interventions were inadequate.
- A progress note, dated December 14, 2022, describes R60's exit-seeking behavior "early in the shift" and reports that continued redirection was needed throughout the shift for "disrobing behaviors." CMS Ex. 19 at 8.
- A progress note, dated December 15, 2022, at 10:31 a.m., describes the resident as yelling loudly and exit-seeking. He wheeled himself up to the East Unit exit and pushed the door open. Staff "redirected." CMS Ex. 19 at 6.
- At 5:15 p.m. that day (December 15), the nurse again reports R60's exit-seeking behavior and elopement attempt. He set off the alarm to the East Side door at the end of the hallway, and then set off the alarm to the door by the nurses' station. He then wheeled to the front door by the receptionist desk and attempted to open the door leading to the main steps to the building. During this time, he was yelling the word, "no," with profanities "loudly for the last 30 minutes." The nurse comments that he "is becoming difficult to redirect." CMS Ex. 19 at 5-6.
- A licensed practical nurse (LPN), identified as LPN107 (see CMS Ex. 13 at 2) reported that, on the afternoon of December 17, 2022, R60 went to the East Wing door and pushed it open. His wife, who was with him, told him to back away. When he did not, she pulled his wheelchair back and warned him, "You will fall over those steps and die." CMS Ex. 25 at 1; P. Ex. 4 at 7.
Staff reported that, throughout the day of December 18, 2022, R60 repeatedly tried to exit the facility. When staff attempted to redirect him, he would become upset and attempt to exit through a different door. CMS Ex. 25 at 2, 3, 8, 9.
- At 12:27 a.m. on December 18, 2022, R60 is again described as "exit-seeking." The nurse reported that staff were sitting with him, one-on-one, to prevent him from exiting. Nevertheless, his attempts continued throughout the shift, and redirection was ineffective. CMS Ex. 19 at 2.
- At 1:57 p.m. on December 18, 2022, R60 was exit-seeking and tried to leave through the double doors at the end of the East Unit. He made it through the first door and tried the second door. The nurse and the nurse aide redirected him back
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into the facility. The nurse reports that R60 "is exit seeking more and more daily." CMS Ex. 19 at 2.
- At 3:05 p.m. on December 18, 2022, R60 again tried to exit through the double door at the East end of the hallway. He was yelling, "They tricked me[;] they trapped me here." CMS Ex. 19 at 2.
The elopement and accident. A nurse aide (Nurse Aide 77) reported that R60 was with her at the nurses' station at 4:10 p.m. on December 18, 2022. He had been exit-seeking the entire shift. Nevertheless, she left him unsupervised when a nurse, working in a room down the hall, asked for her help pulling a resident up in bed. Nurse Aide 77 reported that she left R60 asleep in his chair. CMS Ex. 25 at 8. On the other hand, one of the assisted-living residents, Resident 401 (R401), who had been smoking on the concrete landing off the East Wing exit, told surveyor Rebekah Sherman that she observed R60 sitting at the nurses' station, and he was awake. CMS Ex. 29 at 9; see CMS Ex. 13 at 3.
In either case, R60 was awake almost immediately after Nurse Aide 77 left him unattended. R401 had been waiting to come back into the facility. She rang the doorbell; R60 opened the door and rolled past her "like he was on a mission." CMS Ex. 29 at 9; see CMS Ex. 13 at 3. She wrote that he "barreled through [the door] and hit the hill" (apparently an incline), which increased his speed in a way that R401 could not stop him. R401 went to look for a staff member. CMS Ex. 25 at 6.
A second assisted-living resident, R402, told Surveyor Sherman that she was also outside smoking when R60 opened the door and came outside. She stepped out of his way because she "did not want to get [run] over by a man in a wheelchair." CMS Ex. 29 at 9; see CMS Ex. 13 at 3.
R401 found a nurse aide (Nurse Aide 120) in the dining room. In her witness statement, Nurse Aide 120 writes that she was talking to another resident when R401 approached and told her that R60 had left the unit and was outside on the East Patio. Nurse Aide 120 ran to the unit and outside, but when she got to the patio, R60 had already fallen down the steps in his wheelchair. Nurse Aide 120 yelled for the nurse. CMS Ex. 25 at 4. Nurse Aide 120 describes what she saw:
[R60] was [lying,] face down on the step with his wheelchair on top of him. He was bleeding pretty badly when we got to him. He was wearing dark blue shorts and a dark blue T-shirt. He was alert [and] oriented. He told us his first [and] last name [and] where he was. He was awake the whole time waiting for the paramedics [and] while being transferred to the ambulance.
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CMS Ex. 25 at 5, 7; see CMS Ex. 19 at 1 (December 20, 2022 note from the interdisciplinary team, reporting the incident).
The nurse who responded reported that at about 4:15 p.m. Nurse Aide 120 yelled out, "He got out, he fell on the steps." CMS Ex. 25 at 7. The nurse found him on the ground (stairs) with the wheelchair upside down. The nurse started first aid and staff called 911. Paramedics arrived and took R60 to the regional medical center. Staff contacted R60's wife and the DON. CMS Ex. 19 at 2; CMS Ex. 25 at 7.
Staff – Nurse Aides 77 and 120 and LPN109 – told Surveyor Sherman that they had not heard the door alarm. CMS Ex. 29 at 7, 9; CMS Ex. 30 at 6 (Sherman Decl. ¶ 20). In the presence of the facility's Maintenance Supervisor and Administrator, Surveyor Sherman tested the alarm. She heard a "very low, barely audible sound." From the opposite end of the East Hallway, she did not hear any sound. CMS Ex. 30 at 6 (Sherman Decl. ¶ 21); see CMS Ex. 27.
R60's death. R60 was taken to Springfield Regional Medical Center. He had multiple fractures – rib, humerus (upper arm), "Le Fort III" (cranial fracture; the midface separates from the cranium). CMS Ex. 22 at 1, 11; CMS Ex. 30 at 6 (Sherman Decl. ¶ 19). On the night of December 18, 2022, he was transferred to Miami Valley Hospital via "CareFlight." CMS Ex. 22 at 4. He was admitted to Miami Valley at 11:09 p.m. CMS Ex. 22 at 7.
R60 died at 3:48 p.m. on December 26, 2022. The cause of death was "blunt force trauma of the head." CMS Ex. 23.
The facility's substantial noncompliance: accident hazards. Two factors underscore how dangerous it was to leave R60 unsupervised on the afternoon of December 18, 2022. First, as he demonstrated repeatedly, he was determined to leave the facility and was fully capable of opening an exit door. Second, his leaving the facility was exceptionally dangerous because of the concrete steps outside each of the exits. As staff must have recognized (and as R60's wife warned), if he got through the door, he would "fall [over the] steps and die." CMS Ex. 25 at 1; P. Ex. 4 at 7. Given the physical layout, the all-but-inaudible door alarm, and the absence of any other safeguards, the facility had not ensured that the resident's environment was free of accident hazards, which put the facility out of substantial compliance with the quality-of-care regulation.
Failure to assess. Nor did the facility otherwise reduce the known risks of accidents "to the greatest degree practicable" by ensuring that R60 received adequate supervision to prevent accidents. A facility has "a responsibility to evaluate those residents who seek to leave [the facility] in order to identify risks and offer alternatives to mitigate those risks." Van Duyn Home & Hosp., DAB No. 2368 at 12 (2011). The facility's policy mandated
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an elopement risk assessment at the time of admission and "as needed." CMS Ex. 34 at 1. But when R60 began exit-seeking, the facility did not reassess his elopement risk.
Even when staff recommended that he be placed in the secured unit, the facility did not assess his elopement risk. On December 12, the DON recommended that R60 be placed in the secured unit without first securing an assessment, as required by the facility's policies:
[B]efore placement [on the secure unit, staff will conduct an] . . . assessment/evaluation of the resident response to such placement and the benefits and risks of the . . . placement . . . . [The] [e]valuation will include: whether less restrictive alternatives have been unsuccessful in preventing safety risks for the resident and others and whether the resident habitually wanders without the capacity to return, presenting a danger to self.
CMS Ex. 35; see CMS Ex. 29 at 6 (DON confirming that no new elopement risk assessments were completed after R60's admission assessment, even though one should have been completed on December 12, 2022).
Inadequate care planning. As the DON recognized, the interventions in place – 15-minute checks and redirection – were obviously inadequate. R60's exit-seeking behavior was unremitting. The facility should have developed a "comprehensive, person-centered care plan" that was based on an assessment (which, unfortunately, did not exist) and that responded to his particular needs. 42 C.F.R. § 483.21(b)(1); CMS Ex. 34 at 1-2 (policy directing staff to "initiate prompt interventions to prevent further exit-seeking" when an incident occurs). An interdisciplinary team should have evaluated the interventions planned and considered why the goals were not being met by these interventions. Sheridan Health Care Ctr., DAB No. 2178 at 38-39 (2008). Because R60's care plan was inadequate, the facility was out of substantial compliance with the quality-of-care regulation. Sheridan, DAB No. 2178 at 37; Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 12 (2012) (finding that the facility was not in substantial compliance with the quality-of-care regulation because it did not have in place an adequate plan to supervise its elopement-prone resident).5
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Failure to investigate. The duty to provide adequate supervision to prevent accidents includes a duty to investigate incidents adequately in order to prevent future accidents. Owensboro Place & Rehab. Ctr., DAB No. 2397 at 14-15 (2011). Here, notwithstanding the multiple times R60 managed to open the exit doors, the facility did not investigate any of these incidents, which meant that it could not identify, understand, and correct its deficient practices. Dumas Nursing & Rehab., L.P., DAB No. 2347 at 15 (2010). This also put the facility out of substantial compliance with section 483.25(d). Beechwood Sanitarium, DAB No. 1906 at 106-107 (2004) (affirming a finding of noncompliance with (then) section 483.25(h) based on the facility's failure to investigate); see Pinecrest, DAB No. 2446 at 12 (finding that the facility "compounded [its] failures by not investigating prior elopements in order to pinpoint why the residents successfully circumvented the facility's security precautions . . . .").
Failure to notify physician. The facility's actions (or inaction) violated other policies. If a resident is at risk for elopement, the facility's policy mandated that staff notify his physician of the risk and recommended interventions. CMS Ex. 34 at 1. When R60's exit-seeking behaviors escalated (certainly by December 12), the facility should have notified his physician. The facility's DON confirmed that it had not done so. CMS Ex. 29 at 8.
R60 experienced a rapid and significant behavioral change. His physician could have examined him and ordered tests to determine if there was a medical reason for the sudden change, which would have been useful information in determining an appropriate response. CMS Ex. 30 at 5 (Sherman Decl. ¶ 16).
Petitioner's defense. Although its efforts to protect R60 from accidents were limited to 15-minute checks and redirection, Petitioner claims that "all . . . reasonable steps were taken with respect to" R60. P. Br. at 3.
Petitioner concedes that it did not complete the required elopement risk assessment but argues that such an assessment would not have made a significant difference. Because R60's wife would not agree to transfer him to the secured unit, Petitioner suggests that the facility's options were limited and completing the required elopement risk assessment was pointless. In short, according to Petitioner, the facility simply could not ensure the resident's safety. P. Br. at 4.6
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If a resident declines to comply with the facility's recommendations (generally presented in a care plan), the facility must "document the noncompliance and develop other interventions for the resident." Van Duyn, DAB No. 2368 at 7. It is not free to accept refusals of care without considering alternative interventions. Unless it modifies a resident's care plan to address the problem, a facility cannot avoid a deficiency citation by claiming to have been honoring the resident's wishes. White Sulphur Springs Ctr., DAB No. 2520 at 15-16 (2013).
Moreover, the facility, no doubt could have provided R60 with more supervision than leaving him alone near an exit door at a time when he had been trying relentlessly to elope. But, according to Petitioner, any more intense level of supervision beyond 15-minute checks was not reasonable "over an extended period." P. Br. at 5. Petitioner has not explained why a heightened level of supervision would necessarily have extended over a long period. Had an assessment established that R60 required the secured unit in order to be safe, the facility might have convinced R60's wife that, to remain in the facility, R60 had to be relocated to the secured unit. If she were still unwilling to agree to the relocation, the facility should have found him an alternative placement that was better equipped to meet his needs and the family's wishes. In the meantime, so long as R60 was in the facility's care, it was obliged to provide him with adequate supervision and an environment as free of accident hazards as possible.
A facility is not free to throw up its hands, decide that nothing more can be done, and leave a vulnerable resident's well-being to the Fates. As the Departmental Appeals Board has recognized, an "undoubtedly difficult" elopement situation "crie[s] out for a well-thought-through assessment and coordinated plan to ensure [the resident's] safety as much as possible." Van Duyn, DAB No. 2368 at 15. Here, the facility performed no assessment and developed no plan. It was therefore not in substantial compliance with section 483.25(d).
- The undisputed evidence establishes that CMS's determination that the facility's substantial noncompliance posed immediate jeopardy to resident health and safety is not clearly erroneous.
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). Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination. The burden is on the facility to show that CMS's determination is clearly erroneous. Woodland Oaks Healthcare Facility, DAB No. 2355 at 17-18 (2010); Grace Healthcare of Benton, DAB No. 2189 at 13 (2008) (citing Liberty Commons Nursing &
Page 16
Rehab Ctr. - Johnston, DAB No. 2031 at 17-18 (2006), aff'd, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App'x 76 (4th Cir. 2007)).
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. 1962 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007); see Yakima Valley Sch., DAB No. 2422 at 8 (2011) (holding that the "clearly erroneous" standard is highly deferential and "places a heavy burden on the facility to upset CMS's finding regarding the level of noncompliance.").
Except to argue that it was in substantial compliance with section 483.25(d), Petitioner offers no evidence or argument suggesting that its deficiency did not pose immediate jeopardy to resident health and safety. The facility did not reduce foreseeable risks of accidents to the greatest degree practicable, and it did not adequately supervise an exceptionally vulnerable resident. The resident was not properly assessed for his elopement risk; his care plan was not updated to address his unrelenting exit-seeking. Without a care-plan instruction to prevent it, staff left the aggressively exit-seeking resident alone and unsupervised near an exit door. Finding that these failures were likely to cause R60 serious injury is not clearly erroneous, particularly since the resident was seriously injured and died as a result.
- The CMP imposed – $7,320 per day for 11 days of immediate jeopardy – is not unreasonably high.
Determining whether the penalty is 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 section 488.404 factors 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.
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
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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).
I determine whether a penalty is reasonable based on the per-day penalty, not the total accrued penalty. Vibra Hosp. of Charleston - TCU, DAB No. 3094 at 30 (2023); Crawford Healthcare & Rehab., DAB No. 2738 at 20 (2016).
The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable. Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017) (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 26-27 (2011)). Here, Petitioner offers no evidence or argument except to claim no potential harm and to assert that the cited deficiencies should be deleted. P. Br. at 24.
Penalties are inflation-adjusted and change annually. The amount is determined as of the date the penalty is assessed, in this case, May 23, 2023. CMS Ex. 7; 87 Fed. Reg. 15,100, 15,111 (Mar. 17, 2022). Here, CMS imposed a per-day CMP of $7,320 per day, which is a scant $3.00 above the minimum CMP for instances of immediate jeopardy ($7,317 to $23,989). 42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 87 Fed. Reg. at 15,111 (Mar. 17, 2022).
CMS presents evidence showing that the facility had a less than stellar compliance history. In the surveys completed from February 2020 through September 2022, the facility was consistently found out of substantial compliance, with deficiencies cited at scope and severity levels D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm) and F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm). CMS Ex. 39. By itself, the facility's history justifies raising the CMP well above the minimum.7
With respect to the facility's financial condition, it is well-settled that the facility has the burden of proving, by a preponderance of the evidence, that paying the CMP would render it insolvent or would compromise the health and safety of its residents. Van Duyn, DAB No. 2368; Gillman Care Ctr., DAB No. 2357 (2010). Petitioner does not claim that it is unable to pay the penalty.
Applying the remaining factors, the additional two deficiencies, which Petitioner has not challenged, justify raising the CMP. I have also discussed in some detail the facility's significant failure to provide R60 with the supervision he needed to keep him safe.
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Indeed, the facility did not meet minimal requirements – to assess and develop a care plan that addressed the resident's significant needs. For these failures, the facility is culpable.
Petitioner has thus not established that this relatively low CMP is unreasonable.
Conclusion
From December 18, 2022, through January 17, 2023, the facility was not in substantial compliance with 42 C.F.R. § 483.25(d). From December 18 through 28, 2022, its deficiencies posed immediate jeopardy to resident health and safety. The penalty imposed – $7,320 per day for 11 days of immediate jeopardy – is reasonable.
Carolyn Cozad Hughes Administrative Law Judge
- 1
Deciding a case on the written record (or on summary judgment) does not mean that it is decided without a hearing. Courts that decide cases without an in-person hearing have been careful to avoid any suggestion that the case is decided without a hearing. Throughout their decisions, they refer to deciding the case without an "oral hearing" or without an "evidentiary hearing." Although a case may be decided based on the written record, an administrative law judge (ALJ), by considering the evidence and applying the law, has granted the petitioner a hearing, as required by sections 205(b) and 1866(h) of the Act. See 42 C.F.R. § 498.66(d) (on conducting a hearing without oral testimony); CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a "paper hearing" satisfies statutory requirements for "notice and opportunity for hearing.").
- 2
My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.
- 3
This assertion is not fully supported by the progress notes, which also describe the behavior occurring at 6:47 a.m., 9:28 a.m., and 4:11 a.m. CMS Ex. 19 at 12, 16.
- 4
Some evidence suggests that the alternative placement was not available, at least not at the specific institution that R60's wife named. The facility social worker told Surveyor Sherman that she did not follow-up on an alternative placement because the family decided to keep R60 at the facility. CMS Ex. 29 at 7. Petitioner has not denied that the social worker made this statement nor claimed that the statement is untrue. See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (2004) (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).
- 5
The long-term-care regulations were revised in October 2016, and the requirement that facilities minimize the risk of accidents was moved from 42 C.F.R. § 483.25(h) to 42 C.F.R. § 483.25(d). 81 Fed. Reg. 68,688, 68,828 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017). The substance of the requirements (which are statutory) did not change, and the cases decided prior to October 2016 remain valid.
- 6
The facility was, of course, free to choose its own methods, so long as they were adequate, but CMS has suggested a few options: one-on-one supervision, exit-door monitoring, upgrading the door alarm system. CMS Br. at 19; CMS Ex. 30 at 6-7 (Sherman Decl. ¶ 23).
- 7
The facility's history shows that CMS did not impose significant remedies. CMS Ex. 39. Given its history of repeated noncompliance, it appears that the low (or nonexistent) CMPs previously imposed were not sufficient to produce corrective action.