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                              Wynwood Rehabilitation and Health Care Center, DAB CR6252 (2023)
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Wynwood Rehabilitation and Health Care Center, DAB CR6252 (2023)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Wynwood Rehabilitation and Health Care Center
(CCN: 31-5047),

v.

Centers for Medicare & Medicaid Services
Docket No. C-20-216Decision No. CR6252March 13, 2023

        
              
    

      DECISION

Wynwood Rehabilitation and Health Care Center (Petitioner or the facility) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with the Medicare program participation requirement at 42 C.F.R. § 483.25(d)(1), (2) (Tag F689) and that the cited noncompliance posed immediate jeopardy to resident health and safety.  Petitioner also challenges the imposition of remedies, including a per‐day civil money penalty (CMP) of $7,267 for 38 days and a $110 per-day CMP for seven days, for a total CMP of $276,916.  For the reasons discussed below, I find that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(d)(1), (2).  I also conclude that the per‐day CMPs imposed are reasonable.

I. Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Cinnaminson, New Jersey.  *See* CMS Exhibit (Ex.) 1 at 1.  The New Jersey State Department of Health, Office of Long Term Care (state agency) conducted a survey at Petitioner’s facility from July 24 to July 26, 2019.  *Id.*; *see also*CMS Ex. 2 at 1.**Based on the survey, CMS concluded Petitioner

**Page 2**

was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) (Tag F689 – Free of Accident Hazards/Supervision/Devices) at scope and severity level “K.”1  CMS Ex. 2 at 1.  CMS determined the noncompliance represented immediate jeopardy to resident health and safety.  *Id.*

By letter dated October 23, 2019, CMS notified Petitioner that it had imposed per‐day CMPs of $7,267 for 38 days of immediate jeopardy level noncompliance from June 16, 2019, through July 23, 2019, (a total of $276,146), and $110 for seven days of continued noncompliance from July 24, 2019, through July 30, 2019, (a total of $770), for a total CMP of $276,916.  *Id.*at 1-2. **In the same letter, CMS stated that, based on a September 9, 2019 revisit survey, the facility returned to substantial compliance on July 31, 2019.  *Id.*at 1.

Petitioner timely appealed CMS’s imposition of remedies and the case was assigned to me for a hearing and decision.  My office acknowledged receipt of Petitioner’s hearing request and provided a copy of my Standing Prehearing Order (Prehearing Order).  Pursuant to the Prehearing Order, CMS filed its Prehearing Brief and Motion for Partial Summary Judgment (CMS Br.).  CMS also filed 11 proposed exhibits, including the written direct testimony of one witness.  Petitioner filed a Prehearing Brief and Opposition to CMS’s Motion for Partial Summary Judgment (P. Br.).  Petitioner also filed six proposed exhibits, including the written direct testimony of two witnesses.  Petitioner requested to cross-examine CMS’s proposed witness, state agency surveyor Shawn Shields, RN.  CMS did not request to cross‐examine either of Petitioner’s proposed witnesses.

I denied CMS’s motion for partial summary judgment in a ruling issued March 16, 2021.  I convened a telephone prehearing conference to set a hearing date.  Because neither party had objected to the other party’s proposed exhibits, I informed the parties that I intended to summarily admit CMS Exs. 1‐8, 10, and 11, and P. Exs. 1‐6 at the beginning of the hearing.  I reserved ruling on the admissibility of CMS’s witness declaration (CMS Ex. 9) until the hearing.

**Page 3**

On September 13, 2021, I held a hearing by video teleconference and a transcript (Tr.) was made of the proceeding.  I presided remotely from my home office in the greater Washington, D.C. area.  Diane Schmitt, Esq. and Quinn Carlson, Esq., represented Petitioner and appeared from Baltimore, Maryland and Memphis, Tennessee, respectively.  Tr. at 1.2  David Rawson, Assistant Regional Counsel, represented CMS and appeared from Brooklyn, New York.  Id. at 1-2.  In the absence of objection, I admitted into evidence CMS Exs. 1 8, 10, and 11, and P. Exs. 1 6.  Id. at 4.  I admitted CMS Ex. 9 into the record after the witness authenticated his written direct testimony.  Tr. at 12.

Following the hearing, the parties filed post‐hearing briefs (CMS Post‐hrg. Br., P. Post‐hrg. Br.) and post‐hearing replies (CMS Reply, P. Reply).  Along with its post‐hearing brief, Petitioner filed two additional proposed exhibits (P. Exs. 7, 8).3  Absent objection, I admit P. Ex. 7 into the record.

CMS objected to P. Ex. 8, which consists of two in-service training sign-in sheets dated June 17, 2019.  CMS argues P. Ex. 8 is prejudicial because Petitioner did not offer testimony establishing a foundation for the exhibit.  CMS Reply at 9.  CMS therefore contends that the record fails to establish the relevance of the documents, when the documents were created, whether all staff attended the referenced in‐service trainings, and whether Petitioner provided the documents to the state agency surveyor during the survey.  *Id.*; *see also*Tr. at 25.  Petitioner appears to rely on P. Ex. 8 to support its assertion that, following Resident 1’s elopement, it retrained staff on the facility’s elopement procedures and door alarm function.  *See* P. Post-hrg. Br. at 11-12.  I admit P. Ex. 8 over CMS’s objection.  I accept P. Ex. 8 as evidence that Petitioner retrained staff after a resident eloped.  However, I afford little weight to the exhibit in determining whether Petitioner returned to substantial compliance prior to the survey.  As CMS points out, Petitioner did not offer any testimony or documentary evidence to prove what the training covered and whether all staff attended the training.

**Page 4**

II. Issues

The issues in this case are:

Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) (Tag F689);
	If Petitioner was not in substantial compliance, whether CMS’s determination that immediate jeopardy existed at the facility from June 16, 2019, through July 23, 2019, was clearly erroneous; and
	If Petitioner was not in substantial compliance with Medicare participation requirements, whether the per-day CMPs imposed are reasonable.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 Health & 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. part 483.

To participate in Medicare, a 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 or 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.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301.

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 and regulations require that facilities be surveyed on average every twelve months, and more

**Page 5**

often if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  When the results of a survey show that a SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies such as CMPs.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)); 42 C.F.R. § 488.406.

If CMS imposes a CMP based on a noncompliance determination, then the SNF may request a hearing before an administrative law judge to challenge CMS’s determination of noncompliance that led to the imposition of an enforcement remedy.  A SNF may challenge CMS’s finding as to the level of noncompliance only if a successful challenge would affect the range of CMP amounts imposed on the SNF.  Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (42 U.S.C. §§ 1320a‐7a(c)(2), 1395i‐3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 488.434(a)(2)(viii), 498.3(b)(13)-(14); *see also* 5 U.S.C. §§ 554, 556.  Further, where a challenge to the level of noncompliance is permitted, CMS’s determination as to the level of noncompliance must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

In a hearing before an administrative law judge, CMS must make a prima facie case that the SNF failed to comply substantially with federal participation requirements.  If CMS makes a prima facie case, the burden of persuasion shifts to the SNF, which must prove substantial compliance by a preponderance of the evidence.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff’d sub nom. Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs.*, No. Civ. A-98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d sub nom. Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998).

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

***1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) because it did not take all reasonable steps to ensure the resident environment was as free of accident hazards as possible and that residents who were assessed as elopement risks were provided with adequate supervision and assistive devices to prevent their elopement from the facility.***4

Section 483.25 of 42 C.F.R., which governs quality of care, provides generally that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the

**Page 6**

resident’s choices.”  Subsection 483.25(d) specifically obliges facilities to minimize accident hazards and prevent 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 decisions of the Departmental Appeals Board (DAB) have held that the regulations require facilities to address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.”  *Meadowwood Nursing Ctr.*, DAB No. 2541 at 2 (2013) (citing *Me. Veterans’ Home – Scarborough*, DAB No. 1975 at 10 (2005)) (internal quotation marks omitted).5  Subsection 483.25(d)(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”)).

Though facilities have “the flexibility to choose the methods of supervision and assistance used to prevent accidents,” they must “provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice.”  *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 6 (2017) (citing *Century Care of Crystal Coast*, DAB No. 2076 at 6-7 (2007), *aff’d*, *Century Care of Crystal Coast v. Leavitt*, 281 F. App’x 180 (4th Cir. 2008)).  The chosen methods must “constitute an ‘adequate’ level of supervision under all circumstances.”  *Windsor Health Care Ctr.*, DAB No. 1902 (2003) (2003 WL 23142160 at *3), *aff’d* *sub nom.* *Windsor Health Ctr. v. Leavitt*, 127 F. App’x 843 (6th Cir. 2005).

**Page 7**

CMS alleges Petitioner failed to comply substantially with 42 C.F.R. § 483.25(d)(1), (2) because it did not protect a severely cognitively impaired resident, who Petitioner identified as at risk from wandering behavior, from eloping from the facility through a door that failed to properly alarm.  *See, e.g.,*CMS Post‐hrg. Br. at 2-5.  CMS also alleges the facility’s elopement prevention methods remained deficient at the time of the survey because tests revealed the facility’s Wander Guard6 system did not function properly.  *See id.* at 5‐6.  CMS argues that the malfunctioning door alarm and Wander Guard system constituted a violation of 42 C.F.R. § 483.25(d)(1), (2) and placed Petitioner’s residents in immediate jeopardy.  *Id.* at 7-8.

Petitioner does not dispute Resident 1 eloped from the facility.  *See, e.g.,*P. Post-hrg. Br. at 10-11.  However, Petitioner contends Resident 1’s elopement was not related to the Wander Guard system.  *Id.*at 11.  Petitioner additionally argues that, once staff discovered Resident 1 was not in his bed, they quickly and accurately implemented the facility’s elopement procedures.  *Id.* at 12-13.  Petitioner also asserts the surveyor’s tests of the Wander Guard system were flawed.  *Id.* at 17-18.**Finally, Petitioner argues that the finding of immediate jeopardy from June 16, 2019, through July 23, 2019, is clearly erroneous.  *Id.*at 18-20.

The weight of the evidence establishes that Petitioner did not substantially comply with 42 C.F.R. § 483.25(d)(1), (2).  As I explain in greater detail below, I find that, by failing to ensure its door alarms and residents’ Wander Guards functioned properly, Petitioner did not take “all reasonable steps” to protect residents at risk for elopement.  *See Briarwood*, DAB No. 2115 at 11.  As such, Petitioner failed to “provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice.”  *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 6 (internal quotation marks omitted).

I find the following facts by a preponderance of the evidence.  Petitioner’s facility had nine exit doors.  CMS Ex. 8 at 11; Tr. at 14.  Of those nine doors, only two doors were connected to the Wander Guard system:  the front door and employee entrance door.  P. Ex. 1 ¶ 6; Tr. at 14, 27.  Pinchos Bak, an owner of the facility, testified that the facility’s Wander Guard system included a sensor that locked the door when someone wearing a Wander Guard bracelet pushed the exit button and an alarm that sounded when someone wearing a Wander Guard bracelet exited the door.  P. Ex. 1 ¶ 7.

The front door of the facility was always closed and could only be opened by pushing the exit button.  Tr. at 29.  A receptionist staffed the front desk from 8:00 a.m. to 8:00 p.m.

**Page 8**

daily.  P. Ex. 1 ¶ 11; P. Ex. 2 ¶ 9; Tr. at 33.  After 8:00 p.m., the front doors were locked and did not open even if someone who was not wearing a Wander Guard pushed the exit button.  P. Ex. 1 ¶ 11; P. Ex. 2 ¶ 9; Tr. at 47.  A binder at the front desk contained the picture and care sheet of every resident identified as a wander or elopement risk.  P. Ex. 2 ¶ 10.

The other seven doors operated with a turnkey alarm system that sounded an alarm only after someone pressed the exit button for approximately 15 seconds and the door opened.  P. Ex. 1 ¶ 8; Tr. at 14, 27*.*Maintenance staff checked all exit doors twice a day.  P. Ex. 1 ¶ 10.

At the time of the incident at issue, Resident 1 was a 70-year-old man who had resided at Petitioner’s facility since April 4, 2019.  CMS Ex. 4 at 4.  Resident 1’s diagnoses included unspecified sequelae of cerebral infarction and unspecified dementia with behavioral disturbance, among others.  *Id.* at 4-5.  Resident 1 had a Brief Interview for Mental Status (BIMS) score of “0,” indicating his cognition was severely impaired.7  CMS Ex. 1 at 13; CMS Ex. 4 at 3; CMS Ex. 9 ¶ 8.  Resident 1 could transfer and propel a wheelchair by himself.  CMS Ex. 4 at 14.  Resident 1’s care plan documented that he wandered and paced to the point of exhaustion and had periods of confusion related to cognitive impairment and dementia.  CMS Ex. 4 at 6, 8, 9.  Interventions included monitoring him closely during acute episodes of behavior to keep the resident and others safe and placing a Wander Guard bracelet on the resident’s left ankle.  CMS Ex. 4 at 6.

Resident 1’s care plan suggests that the Wander Guard was initiated June 18, 2019 (i.e., after the resident eloped on June 16).  *See*CMS Ex. 4 at 6.  However, I find it more likely than not that the Wander Guard was implemented between June 9-12, 2019.  An Active Orders report for Resident 1 documents a June 9 telephone order from Resident 1’s physician directing staff to check the placement of the Wander Guard at every shift.  P. Ex. 3 at 1.  Further, Petitioner’s Treatment Administration Records (TAR) for Resident 1 include entries documenting that staff began checking the placement and function of Resident 1’s Wander Guard beginning on June 12.  CMS Ex. 11 at 1-2.  Nevertheless, despite the physician’s order to check Resident 1’s Wander Guard every shift, the TAR shows that staff failed to make some of the required checks on June 16, 23, 24, and July 7, 19, 22, 23, and 24.  *Id.* at 1-3.

**Page 9**

On June 16, 2019, at approximately 3:05 a.m., a Certified Nursing Assistant (CNA) noticed Resident 1 was not in his bed.  CMS Ex. 4 at 13-14.  The CNA notified the charge nurse and supervisor, who began a room-to-room search of the unit.  *Id.* at 14, 17, 20, 21.  Staff were initially unable to find the resident; so, at approximately 3:15 a.m., the nursing supervisor initiated a “Code Gray,” which is the facility’s elopement response.  *Id.*at 20, 21; *see also*CMS Ex. 3 at 2.  The CNAs and supervisor continued searching inside the building and two Licensed Practical Nurses (LPNs) searched outside the building.  *Id.*at 14, 17, 20-22.  At around 3:30 a.m., an LPN found Resident 1, without his wheelchair, sitting across the street from the facility near a six‐lane highway and brought him back to the facility.  *Id.*at 14, 17, 20-22; Tr. at 9.  Upon returning to the facility, staff performed a complete head-to-toe assessment and determined Resident 1 did not have any injuries.  CMS Ex. 4 at 14, 16, 17, 20, 21, 24; CMS Ex. 9 ¶ 40; Tr. at 23.

In the immediate aftermath of Resident 1’s elopement, Petitioner’s staff tested his Wander Guard with a transmitter and found that it was functional.  CMS Ex. 4 at 17, 24; Tr. at 16.  However, Petitioner replaced the Wander Guard because the door alarm had not sounded when staff wheeled Resident 1 “to back door and front door.”  CMS Ex. 4 at 17, 24*.*  Also, the same day that Resident 1 eloped, staff completed an “Elopement Risk Evaluation” form.  *Id.*at 23.  According to the entries, Resident 1 was ambulatory, “disoriented at all times,” and demonstrated “purposeful exit seeking.”  *Id.* Resident 1’s elopement risk score was 20, where any score over 10 indicates a risk for elopement.  *Id.*As part of an elopement care plan, Petitioner monitored Resident 1 every 15 minutes for 24 hours for safety; placed him on 24-hour report for three days to monitor for exit-seeking behaviors; and referred him for a psychology consult.  *Id.*at 7, 10, 16, 17; Tr. at 16.

Petitioner investigated the incident and concluded that Resident 1 had eloped through the exit door nearest his room.  CMS Ex. 4 at 16.  The door through which Resident 1 exited is identified as #4 on a floorplan of the facility.  CMS Ex. 8 at 11; *see also*CMS Ex. 9 ¶ 38; Tr. at 21-22.  Exit door #4 was equipped with the turnkey alarm system, but the alarm did not sound when Resident 1 exited.  CMS Ex. 9 ¶¶ 38, 40; *see also*; Tr. at 14, 15, 27.  The facility was unable to determine whether the alarm did not sound because it malfunctioned or because an employee failed to reset the alarm.  CMS Ex. 4 at 16; Tr. at 22.  In response, the facility immediately changed the batteries for all door alarms.  CMS Ex. 4 at 16; *see also*Tr. at 21.

Following Resident 1’s elopement, Petitioner assessed the function of all alarmed doors, which all worked properly; re-educated supervisors on how to check the function of alarmed doors; and educated staff on alarming and functioning of doors and floor staff responsibility.  CMS Ex. 4 at 16; Tr. at 16, 22.  Petitioner also completed in‐service training on its elopement policy.  P. Ex. 8.  Petitioner last conducted an in‐service training on elopement policies and procedures on February 12, 2019.  P. Ex. 4; Tr. at 40.

**Page 10**

Petitioner reported to the state agency that Resident 1 had eloped.  CMS Ex. 4 at 13-16.  Based on the facility’s self-report, the state agency conducted a survey from July 24 through July 26, 2019.  CMS Ex. 1; CMS Ex. 9 ¶ 3; Tr. at 13.  Shawn Shields, RN (Surveyor Shields), was a member of the survey team for the July 26 survey.  CMS Ex. 9 ¶ 2; Tr. at 13.  While at the facility, Surveyor Shields made observations, conducted interviews, and reviewed records.  *See, e.g.,*CMS Ex. 9 ¶¶ 31, 35, 41.  He made notes during his investigation.  CMS Ex. 8.  Surveyor Shields drafted the statement of deficiencies.  CMS Ex. 9 ¶ 2.** Unless I explicitly state otherwise, I find it more likely than not that the statements and observations in the statement of deficiencies for the survey accurately record what Surveyor Shields observed during his review of Petitioner’s records and his interviews with Petitioner’s employees.

At the time of the survey, Resident 9 was 61 years old, Resident 10 was 84 years old, and Resident 11 was 69 years old.  CMS Ex. 5 at 4; CMS Ex. 6 at 4; CMS Ex. 7 at 4.  All three residents had moderate cognitive impairment and required assistance with activities of daily living.  CMS Ex. 9 ¶¶ 16, 21, 26.  The residents were elopement risks and required a Wander Guard due to confusion, wandering, and pacing.  CMS Ex. 5 at 9, 16; CMS Ex. 6 at 7-8, 14; CMS Ex. 7 at 7-8, 15.  Residents 10 and 11 also had a history of attempts to leave the facility unattended.  CMS Ex. 6 at 14; CMS Ex. 7 at 15.  A physician ordered staff to check the function and placement of the residents’ Wander Guards at every shift.  CMS Ex. 5 at 10; CMS Ex. 6 at 10; CMS Ex. 7 at 12.  Despite the physician orders, TARs for June and July showed staff failed to check the function of placement of the residents’ Wander Guards during some shifts.  CMS Ex. 5 at 14‐15; CMS Ex. 6 at 12-13; CMS Ex. 7 at 13-14.

At 10:00 a.m. on July 24, in the presence of a maintenance staff person, Surveyor Shields tested Resident 10’s and Resident 11’s Wander Guard devices.  CMS Ex. 9 ¶ 32.  The devices did not function properly.  *Id.*  The maintenance staff person replaced the nonfunctioning devices with new devices.  *Id.*

Surveyor Shields then conducted a test of the facility’s Wander Guard system in the presence of a maintenance staff person and Mr. Bak.  CMS Ex. 9 ¶ 33.  Resident 9, who wore a Wander Guard on his right ankle, walked side-by-side with a CNA as the CNA pushed the button to open the front door.  *Id.*  The door did not lock and the alarm did not sound, allowing Resident 9 to exit the facility.  *Id.* ¶ 34; *see also*CMS Ex. 8 at 4.  The maintenance staff member tested Resident 9’s Wander Guard bracelet with a transponder and found the device to be functioning properly.  CMS Ex. 9 ¶ 34; P. Ex. 1 ¶ 21*.*  The surveyor repeated the test five minutes later and the Wander Guard system again failed to activate, allowing Resident 9 to exit the facility.  CMS Ex. 9 ¶ 34.  Mr. Bak stated the sensor may have been too high to detect the resident’s device, which was on his ankle.  CMS Ex. 8 at 4; Tr. at 35, 46.  Later that day, Mr. Bak placed the Wander Guard on his own ankle and pushed the button for the front door, which did not open.  P. Ex. 1 ¶ 22; Tr. at 35; *see*Tr. at 47‐48.

**Page 11**

In the following sections of this decision, I explain why I conclude that the facts I have found above demonstrate that Petitioner failed to comply substantially with Medicare participation requirements.

***a. Petitioner did not take all reasonable measures to prevent a severely cognitively impaired resident, who had a history of wandering, from eloping from the facility unobserved because it failed to ensure that its exit door alarms functioned properly.***

CMS alleges Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) because Petitioner failed to prevent Resident 1 from eloping from the facility.  CMS Post‐hrg. Br. at 2‐3.  Petitioner urges me to conclude it substantially complied with 42 C.F.R. § 483.25(d)(1), (2) because it properly assessed Resident 1 as a wanderer and implemented appropriate interventions to reduce the risk of injury to Resident 1, including placing a Wander Guard on Resident 1’s left ankle.  P. Post‐hrg. Br. at 9-10; *see* CMS Ex. 4 at 6.  Petitioner contends Resident 1’s elopement is not sufficient to establish a prima facie case of noncompliance with 42 C.F.R. § 483.25(d)(1), (2).  P. Post‐hrg. Br. at 6.

As Petitioner correctly points out, the fact that a resident eloped does not by itself prove that a facility provided inadequate supervision and assistive devices to prevent accidents.  *Id.* at 7 (citing *Vandalia Park*,**DAB No. 1939 (2004); *Madison Health Care, Inc.*, DAB No. 1927 (2004)).  Petitioner contends that it implemented both facility-wide and tailored interventions to address the risk that Resident 1 would experience an accident due to his wandering.  P. Post-hrg. Br. at 9.  Petitioner implies that Resident 1 eloped due to circumstances beyond the facility’s control and, accordingly, that the elopement was unavoidable and unforeseeable.  *Id.*at 6.  I disagree.

While it is true that facilities have the flexibility to choose the methods used to prevent accidents, the chosen methods must still provide an adequate level of supervision under all circumstances.  *See**Heritage Plaza*, DAB No. 2829 at 6; *Windsor*, DAB No. 1902 (2003 WL 23142160 at *3).  Here, the evidence establishes Petitioner did not comply substantially with 42 C.F.R. § 483.25(d)(1), (2) because its supervision of Resident 1 and the assistive devices it employed were not adequate to mitigate the risks posed by the resident’s wandering and elopement.  Contrary to Petitioner’s arguments, several of the interventions Petitioner implemented were ineffective due to factors that were well within Petitioner’s ability to control.

First, Petitioner contends that the Wander Guard system “played no part” in Resident 1’s elopement.  P. Post‐hrg. Br. at 12.  According to Petitioner, I should disregard any issues with the Wander Guard because Resident 1 eloped through a door that is not connected to the Wander Guard system.  *Id.* It is accurate that the Wander Guard system could not have detected the resident exiting from a door that did not have a sensor connected to the

**Page 12**

system.  Nevertheless, I find the assertion that the Wander Guard played no role in Resident 1’s elopement inconsistent with Petitioner’s insistence that placing a Wander Guard device on Resident 1 was an effective intervention as part of its overall strategy for preventing elopements.  P. Post-hrg. Br. at 9-10, 12-13.

In any event, the regulation does not require facilities to utilize the Wander Guard system or any other specific accident‐prevention method.  *See* *Lifehouse of Riverside Healthcare Ctr.*, DAB No. 2774 at 15 (2017).  Rather, the regulation requires that, whatever methods the facility chooses, the methods are sufficient to ensure the safety of residents, particularly those who wander.  *See* 42 C.F.R. § 483.25(d)(1), (2).  Once a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents, the facility is required to follow through on them.  *Lifehouse*, DAB No. 2774 at 15*.*Petitioner chose to implement the Wander Guard system; therefore, it was required to ensure the Wander Guard was adequate to prevent elopements.  Yet, Petitioner’s implementation of the Wander Guard system left gaps that exposed its residents to the risk of elopement.

To address Resident 1’s tendency to wander, Petitioner placed a Wander Guard bracelet on his ankle.  CMS Ex. 4 at 6.  Based on the decision to implement the Wander Guard for Resident 1, I infer Petitioner’s staff perceived a risk that Resident 1 could elope from the facility.  Resident 1’s physician ordered staff to check the resident’s Wander Guard at every shift.  P. Ex. 3 at 1.  However, Resident 1’s TAR showed staff did not check his Wander Guard for placement on multiple occasions during June and July 2019.  CMS Ex. 11 at 1‐3.  For example, staff failed to document that they checked the Wander Guard during the 3-11 shift on June 16, 2019, the date on which Resident 1 had already eloped.  *Id.*at 1.  Further, and contrary to Petitioner’s assertion that the Wander Guard system was functioning properly on the night Resident 1 eloped (P. Post‐hrg. Br. at 12), a nursing note documented that when staff wheeled the resident “to back door and front door,” the Wander Guard alarm did not activate (CMS Ex. 4 at 24).  For these reasons, I conclude that inadequacies in the Wander Guard system were a factor supporting Petitioner’s noncompliance.

Additionally, staff did not monitor Resident 1 closely as directed by his care plan.  *See*CMS Ex. 4 at 6.  On the night Resident 1 eloped, staff did not notice the resident leaving his room and walking out of the facility.  A CNA completing rounds discovered Resident 1 missing from his room at approximately 3:05 a.m., but no staff member knew precisely when Resident 1 left his room or exited the building.  CMS Ex. 4 at 14, 17, 20‐22.  Petitioner also did not know what time Resident 1 exited the facility because the facility did not have security cameras on the south side of the building, where the door through which Resident 1 exited was located.  *See* CMS Ex. 9 ¶ 39; *see also*CMS Ex. 8 at 3.  Further, Petitioner’s records suggest that staff only began monitoring Resident 1 closely *after* he eloped.  *See, e.g.,*CMS Ex. 4 at 16 (monitoring Resident 1 every 15 minutes listed as an intervention implemented after the incident).  Presumably, if Petitioner had

**Page 13**

documentation that its staff performed such monitoring before Resident 1 eloped, Petitioner would have produced it for the record.

The facility-wide methods Petitioner implemented were also inadequate to protect Resident 1 from eloping.  Petitioner contends that its elopement prevention measures were robust.  *See, e.g.,*P. Post-hrg. Br. at 3-4.  In particular, Petitioner points out that it staffed the front desk from 8:00 a.m. to 8:00 p.m. every day, locked the front door after 8:00 p.m., and kept a binder of residents identified as elopement risks at the front desk.  P. Br. at 11; P. Ex. 1 ¶ 11; P. Ex. 2 ¶ 9; Tr. at 33-34, 47.  However, it is apparent that these measures were only effective to mitigate the risk a resident would elope through the front doors.  The measures were not designed to prevent a resident from exiting through one of Petitioner’s other eight exit doors.  As noted previously, the facility had nine total exit doors, only two of which were equipped with the Wander Guard system.  CMS Ex. 8 at 11; P. Ex. 1 ¶ 6; Tr. at 14, 26.  The remaining seven doors were equipped with turnkey alarms.  CMS Ex. 9 ¶ 31.  Anyone, including any resident, could exit any one of those doors by pressing on the door, after which the door would open and an audible alarm was supposed to sound.  CMS Ex. 8 at 6; CMS Ex. 9 ¶ 38.  Maintenance staff checked the door alarms twice daily.  P. Ex. 1 ¶ 10.

Despite the measures Petitioner cited, Resident 1 was able to elope undetected through exit #4.  It is undisputed that the turnkey alarm on that door did not sound when Resident 1 exited.  P. Post-hrg. Br. at 11; *see also*CMS Ex. 4 at 16.  Petitioner never determined why the turnkey alarm failed to sound when Resident 1 eloped, only surmising the alarm inadvertently had not been turned on.  P. Post-hrg. Br. at 11;*see also* CMS Ex. 4 at 16; Tr. at 21‐22; P. Ex. 1 ¶ 13.  Assuming a staff member failed to reset the alarm, this is an avoidable human error, for which Petitioner is responsible.  *See, e.g.,**Kindred Transitional Care and Rehab. - Greenfield*, DAB No. 2792 at 12 (2017) (citing*Ridge Terrace*, DAB No. 1834 at 7-8 (2002)) (“[F]acilities may indeed be held responsible for the actions of their employees in determining whether the facilities have complied with applicable regulations.”).

Petitioner also lists the actions it took when it discovered Resident 1 eloped and following the elopement, including locating the resident within 20 minutes, replacing the batteries in the door alarms and Resident 1’s Wander Guard device, and retraining staff on elopement procedures and checking the functionality of door alarms.  P. Post‐hrg. Br. at 13‐14.  However, these are corrective actions.  As such, they do not establish that Petitioner had measures in place at the time Resident 1 eloped that provided residents with adequate supervision and assistance devices to prevent elopements.

Finally, Petitioner notes Resident 1 did not suffer any injuries and staff returned him to the facility without incident.  P. Post‐hrg. Br. at 13.  However, Petitioner’s noncompliance exposed Resident 1 to the risk of more than minimal harm.  Resident 1 was a vulnerable individual who eloped while it was dark outside at 3:00 a.m.  CMS

**Page 14**

Ex. 4 at 14, 17, 20‐22.  Although he normally used a wheelchair, he did not use his wheelchair to elope from the facility.  *Id.* at 20; CMS Ex. 9 ¶ 40.  He walked out into an unfamiliar environment where he faced numerous hazards, such as tripping and falling due to impaired vision in the dark.  Further, because of his severe cognitive impairments, Resident 1 likely had poor safety awareness and diminished capacity to make sound decisions.  In fact, staff found Resident 1 across the street near a six‐lane highway, where he could have risked being struck by a car.  CMS Ex. 4**at 14, 17, 20‐22; CMS Ex. 8 at 3.  Petitioner also claims Resident 1 was missing for only about 20 minutes.  P. Post‐hrg. Br. at 13.  However, that estimate is unreliable because it is based on when staff discovered Resident 1 was not in his bed.  Moreover, even if Resident 1 was only outside the facility for approximately 20 minutes, the fact that he did not get far “does not mean [he] was not exposed to serious harm or even death.”  *Britthaven, Inc., d/b/a Britthaven of Smithfield*, DAB No. 2018 (2006) (2006 WL 786659 at *14).

While Resident 1 did not have a history of elopement, it is foreseeable that a cognitively impaired resident with a history of wandering could elope from the facility.  Therefore, Petitioner had an obligation to protect him from the risks of eloping from its facility.  *Josephine Sunset Home*, DAB No. 1908 (2004) (2004 WL 714959 at *10).  It is undisputed Resident 1 eloped from the facility unobserved, that the turnkey alarm did not trigger as it should have when Resident 1 exited the door, and that the Wander Guard alarm at the front entrance did not sound when staff brought Resident 1 to that entrance.  For these reasons, Petitioner failed to provide adequate supervision and assistance devices to mitigate Resident 1’s risk of elopement.  Further, that Resident 1 was outside the facility unsupervised and was able to cross a street posed the risk of more than minimal harm to Resident 1.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2).

***b. Petitioner did not provide adequate supervision and assistance devices to prevent elopements because it failed to ensure that its Wander Guard system functioned properly.***

Following Resident 1’s elopement, the facility replaced the batteries in the door alarms and retrained staff on elopement procedures and checking door alarm function.  CMS Ex. 4 at 16; P. Ex. 8; Tr. at 16, 22.  However, CMS alleges Petitioner remained out of substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) as of the survey because Petitioner failed to ensure the Wander Guard system functioned properly to prevent residents with a history of wandering and elopement attempts from eloping.  CMS Post‐hrg. Br. at 5‐7.

Petitioner asserts that its Wander Guard system was functioning as designed.  P. Post-hrg. Br. at 16-17.  According to Petitioner, the surveyor’s test of Resident 9’s Wander Guard device was flawed because the CNA accompanying Resident 9, not Resident 9, pushed the door button.  *Id.*at 16.  Petitioner contends that the CNA pressing the button

**Page 15**

prevented the Wander Guard system from sensing Resident 9’s Wander Guard and automatically locking the door.  *Id.* at 17.  Petitioner points out Resident 9’s Wander Guard worked when tested with the transponder and the door properly locked when Mr. Bak placed the Wander Guard on himself and pushed the door button.8  *Id.*; *see also*Tr. at 35‐36.  Petitioner also asserts that the surveyor was aware Wander Guard systems varied by facility, yet he incorrectly assumed the doors would not open if anyone wearing a Wander Guard was in the vicinity of the doors.  P. Post-hrg. Br.**at 16.

To the extent Petitioner contends I should disregard the deficiency findings because the survey was flawed, Petitioner’s argument lacks merit.  The regulations are clear that “inadequate survey performance does not . . . [i]nvalidate adequately documented deficiencies.”  42 C.F.R. § 488.318(b)(2).  As one DAB decision has explained:

[U]nder the governing administrative appeal regulations, the ultimate issue before an [Administrative Law Judge] is not how the state agency performed the survey or what process it followed to reach its conclusions, but “whether the *evidence* as it is *developed before the [Administrative Law Judge]* supports” CMS’s independent “finding of noncompliance” under the relevant participation requirements.

*Avon Nursing Home*, DAB No. 2830 at 11 (2017) (emphasis in original) (citing *Sunshine Haven of Lordsburg*, DAB No. 2456 at 21 (2012), *aff’d in part and transferred, Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs.*, 742 F.3d 1239 (10th Cir. 2014)).  The *Avon* decision also emphasized that “a state agency’s survey findings constitute *recommendations* to CMS.”  *Id*. at 14 (emphasis in original) (citing 42 C.F.R. §§ 488.11, 488.12).  The decision further explained that “CMS makes its own determination of noncompliance, and decides what enforcement action to take, based on the survey’s findings.”  *Id*.

Because CMS – not the surveyor or the state agency – decides whether to cite deficiencies and impose remedies, even if Petitioner were correct that the survey process was somehow inadequate (which I do not find), Petitioner’s attempt to discredit both the surveyor and his findings must fail.  Moreover, in this proceeding I have afforded Petitioner a de novo review.  A de novo review means that I decide the issues “without deference to CMS’s or the state survey agency’s factual findings or legal conclusions and based on [my] own evaluation of the credibility of the submitted evidence.”  *Avon*, DAB

**Page 16**

No. 2830 at 12 (citing *N.C. State Veterans Nursing Home, Salisbury*, DAB No. 2256 at 24 (2009)).

More importantly, my review of the evidence does not persuade me that CMS or Surveyor Shields erred by concluding that Petitioner’s Wander Guard system was not functioning properly on the day of the survey.  Although Resident 9’s personal Wander Guard device was transmitting when tested with a transponder, when Resident 9 approached the front entrance door, the door failed to lock, and the alarm failed to sound.  CMS Ex. 9 ¶ 34.  Since Resident 9 was near the door, the sensor should have sensed Resident 9’s Wander Guard bracelet and triggered the door lock and sounded the alarm.  Tr. at 45.

Petitioner does not dispute that the front entrance door failed to lock when Resident 9 approached.  However, as previously noted, Petitioner contends that the Wander Guard did not lock because Resident 9 did not push the exit button himself.  Nevertheless, as Surveyor Shields testified, Resident 9 and the CNA who pushed the exit button were “hip by hip.”  *Id.*  Surveyor Shields also pointed out to Petitioner’s owners that, if the Wander Guard only functioned when a resident equipped with a bracelet pushed the button, then a wandering resident could exit the facility when a visitor or another resident without a Wander Guard device pushed the button.  *Id.* at 33.  I agree with this observation.  There were likely many people entering and exiting the facility through the front door each day.  If the Wander Guard door sensor only worked when someone wearing a Wander Guard device pushed the button or if the sensor could be blocked by just one person walking by it, then the system was not an effective method to prevent residents from eloping.

Further, Mr. Bak testified that the Wander Guard system at the front entrance was programmed to both lock the door and sound an alarm.  P. Ex. 1 ¶ 7.  According to the testimony, the alarm sounds “when a Wander[ ]Guard device goes through the exit.”  *Id.* Petitioner has not contended that the Wander Guard sounded when Resident 9 was escorted through the front exit.  Therefore, even if I were to conclude that the failure of Petitioner’s Wander Guard system to lock the door when the CNA pushed the exit button was not a malfunction, I would nevertheless conclude that the system failed to sound the alarm when Resident 9 exited.  Significantly, the Wander Guard door alarms had also failed to sound on the night Resident 1 eloped.  *See*CMS Ex. 4 at 24.

Petitioner reiterates that, even if the alarm did not sound, a receptionist staffed the front desk from 8:00 a.m. to 8:00 p.m., the front door locked after 8:00 p.m., and there was a binder identifying residents at‐risk for eloping at the front desk.  P. Post‐hrg. Br. at 10, 17.  I do not find that these interventions fully compensated for the gaps in the Wander Guard system, however.  For example, the receptionist was likely not focused solely on watching for residents attempting to elope.  If the receptionist was otherwise occupied, such as with assisting a visitor, the receptionist may not have noticed an eloping resident.  Thus, the receptionist’s other duties may have interfered with the vigilance required to

**Page 17**

ensure residents did not elope.  *See Brightview Care Ctr.*, DAB No. 2132 at 19, 20 (2007); *Liberty Nursing & Rehab. Ctr. – Mecklenberg Cty.*, DAB No. 2095 at 17 (2007), *aff’d, Liberty Nursing & Rehabilitation Ctr. - Mecklenburg County v. Leavitt*, 294 F. App’x 803 (4th Cir. 2008).

Petitioner was also out of compliance with the regulation because it did not present any evidence to dispute that Wander Guard devices for Residents 10 and 11 did not function properly when Surveyor Shields tested the devices.  In fact, the record supports that Petitioner failed to ensure numerous residents’ personal Wander Guard devices operated correctly.  The June and July TARs for Residents 1, 9, 10, and 11 showed staff did not check the function or placement of the residents’ Wander Guards at every shift.  CMS Ex. 5 at 14‐15; CMS Ex. 6 at 12-13; CMS Ex. 7 at 13-14; CMS Ex. 11 at 1-3.  Petitioner’s failures exposed cognitively impaired residents, who had a history of wandering and elopement attempts, to the potential for more than minimal harm.

Finally, Petitioner argues CMS inappropriately combined Resident 1’s isolated elopement, which did not involve the Wander Guard system, with the flawed Wander Guard testing the surveyor conducted, to justify finding a pattern of noncompliance.  P. Post-hrg. Br. at 2; P. Reply at 2.  Petitioner contends the determination of whether it was in substantial compliance on June 16, 2019, the date Resident 1 eloped, should be distinct from whether a deficiency existed on July 24, 2019, the date of the survey.  *Id.*Further, Petitioner claims that because it took immediate corrective action following Resident 1’s elopement, any noncompliance that resulted from Resident 1’s elopement was past noncompliance.  P. Post‐hrg. Br. at 20; P. Reply at 4‐5.

As CMS points out, both Resident 1’s elopement and the issues with the Wander Guard system demonstrate flaws in Petitioner’s elopement prevention methods.  *See* CMS Post‐hrg. Br. at 4.  Petitioner’s Wander Guard alarm failed to sound on the night Resident 1 eloped and also failed to do so at the time of the survey.  Similarly, and contrary to the resident’s care plan, Petitioner’s staff failed to monitor the function and placement of Resident 1’s Wander Guard device during a shift on the date Resident 1 eloped.  The inconsistent monitoring of Wander Guard devices continued to affect Resident 1 and other residents up to the time of the survey.  Also, it is undisputed that two residents’ Wander Guard devices were not functioning during the survey.  I therefore disagree with Petitioner’s contention that Resident 1’s elopement was an isolated incident.

Having identified residents at risk for wandering and elopement, the facility was required to do all “it reasonably could” to ensure that those residents received supervision and assistance devices to prevent elopements based on what it knew about the residents’ care needs and the conditions in the facility.  *The Bridge at Rockwood*, DAB No. 2954 at 10‐11 (2019).  The weight of the evidence establishes Petitioner failed to provide each resident with adequate supervision and assistive devices to prevent accidents.  Due to a

**Page 18**

door alarm malfunction or employee error, Resident 1 eloped from the facility unobserved.  Petitioner remained out of compliance with the requirement to provide each resident with adequate supervision and assistive devices to mitigate elopement risks on July 24, 2019, because the front door’s Wander Guard alarm and two residents’ Wander Guard devices did not function properly.  As I have discussed above, Petitioner’s failure to take such reasonable steps posed the risk of more than minimal harm to any of its residents who might succeed in eloping unobserved.  For all these reasons, Petitioner did not comply substantially with 42 C.F.R. § 483.25(d)(1), (2).



***2. Petitioner failed to prove that CMS’s immediate jeopardy determination was clearly erroneous***

CMS determined that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d)(1), (2) posed immediate jeopardy to the health and safety of Petitioner’s residents.  *See, e.g.,*CMS Ex. 2 at 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.  The regulation does not require that a resident *actually*be harmed.  *Lakeport Skilled Nursing Ctr.,*DAB No. 2435 at 8 (2012).  I may not overturn a finding of immediate jeopardy unless I conclude the finding was clearly erroneous.  42 C.F.R. § 498.60(c)(2).

Appellate decisions of the DAB have interpreted section 498.60(c)(2) as creating a presumption that CMS’s finding of immediate jeopardy is correct:

[The clearly erroneous] standard of review requires the [administrative law judge] and the Board in effect to presume that CMS’s determination of immediate jeopardy is correct unless the [facility] demonstrates that the determination is clearly erroneous.

Daughters of Miriam Ctr., DAB No. 2067 at 7 (2007).  Thus, the clearly erroneous standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy.  *Id.; see also Barbourville Nursing Home*, DAB No. 1962 at 11 (2005), *aff’d*, *Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 174 F. App’x 932 (6th Cir. 2006).  Put another way, I may set aside the finding of immediate jeopardy only if, after reviewing all the evidence, I am “left with the definite and firm conviction that a mistake has been committed.”  *Easley v. Cromartie*, 532 U.S. 234, 242 (2001) (internal quotation marks omitted) (citing *United States v. U.S. Gypsum Co.*, 333 U.S. 364, 395 (1948)).  Having reviewed the evidence, I am not left with the definite and firm conviction that the finding of immediate jeopardy was mistaken.  To the contrary, I conclude that the finding of immediate jeopardy must be sustained because it was not clearly erroneous.

**Page 19**

Petitioner argues that CMS’s determination of immediate jeopardy is clearly erroneous because the alleged noncompliance did not create or even increase the likelihood that residents identified as elopement risks and wanderers would elope and suffer serious injury, harm, impairment, or death.  P. Post-hrg. Br. at 19; P. Reply at 4.  Petitioner further argues that no residents were at risk of eloping because the facility had numerous elopement prevention measures in place.  *Id.*

Again, a finding of immediate jeopardy does not require that a resident suffer actual harm.  *Lakeport,*DAB No. 2435 at 8.  Even though Resident 1 was equipped with a Wander Guard bracelet, it is undisputed staff did not know his whereabouts for a period of time.  Moreover, the record calls into question whether Resident 1’s Wander Guard device was working when he eloped.  It is merely fortuitous Resident 1 did not suffer any harm and staff found him as soon as they did.  He walked out of the facility without his wheelchair, which he normally used, into a dark unfamiliar environment at approximately 3:05 a.m., placing him at risk for falling and injuring himself.  He was also at risk of being struck by a vehicle, especially if he wandered onto the six-lane highway nearby.  Further, the likelihood of serious harm or death to Resident 1 was significant because of his cognitive impairment and dementia.

Resident 1 eloped undetected because the turnkey door alarm on the door closest to his room was either not activated or malfunctioned.  Petitioner’s failure to ensure that all door alarms were armed and functioning properly placed Resident 1 and all other residents with wandering and elopement behaviors at risk of injury or death if they eloped from the facility.  Following Resident 1’s elopement, Petitioner continued to be out of compliance at the immediate jeopardy level.  Despite Petitioner’s assertions that no residents were at risk of eloping during the July 24 survey, the record establishes otherwise.  Staff did not consistently check residents’ Wander Guard devices for function and placement.  The front door Wander Guard door lock and alarm did not trigger when tested with Resident 9’s Wander Guard.  Resident 10’s and Resident 11’s Wander Guard devices did not function properly when tested.  All three residents were moderately cognitively impaired and required assistance with activities of daily living, and Residents 10 and 11 had previously attempted to elope.  Had any of the residents successfully eloped from the facility, they were likely to suffer serious injury, harm, impairment, or death caused by the numerous environmental hazards outside the premises, including traffic from the nearby six‐lane highway.

Petitioner did not take all reasonable measures to provide adequate supervision and assistance devices to prevent elopements.  It failed to ensure its door alarm and Wander Guard systems operated properly and did not consistently check residents’ Wander Guard devices as ordered by the residents’ physicians.  These failures placed all residents with elopement and wandering tendencies at risk for eloping from the facility and exposed residents to the likelihood of serious harm, injury, impairment, or death.  Accordingly, I find that CMS did not clearly err in concluding Petitioner’s noncompliance with

**Page 20**

42 C.F.R. § 483.25(d)(1), (2) posed immediate jeopardy to the health and safety of Petitioner’s residents.

***3. The CMPs imposed, $7,267 per day for 38 days and $110 per day for seven days, are reasonable in amount and duration.***

I have concluded that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(d)(1), (2) and that CMS did not clearly err in determining Petitioner’s noncompliance posed immediate jeopardy.  I next explain why I conclude the CMPs imposed for Petitioner’s noncompliance are reasonable in amount and duration.

**Amount.**To determine whether the amount of a CMP is reasonable, I examine 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 imposed, the administrative law judge must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002) (2002 WL 31985890 at *18).

The regulations specify that a per-day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  CMS imposes a CMP in the upper range, $6,524 to $21,393 per day, 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).9  CMS imposes a CMP in the lower range, $107 to $6,418 per day, 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 considers the per day amount, rather than the total accrued CMP.  *See Kenton Healthcare, LLC*,**DAB No. 2186 at 28 (2008).  The regulations leave

**Page 21**

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 sections 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,*DAB No. 2186 at 28-29.

Petitioner urges me to conclude that the total amount of the CMPs imposed is overly punitive.  *See, e.g.,*P. Post-hrg. Br. at 2.  Petitioner implies that the CMP is excessive because CMS imposed a per-day CMP, rather than a per-instance CMP.  *Id.* Petitioner argues that, according to CMS CMP guidance, CMS should have imposed a per-instance CMP because Resident 1’s elopement occurred before the state agency survey.  P. Br. at 19.  However, Petitioner’s argument that CMS should not have imposed a per‐day CMP is specifically foreclosed under the applicable regulations.  A finding by CMS of noncompliance leading to the imposition of a remedy is an initial determination subject to administrative review.  42 C.F.R. § 498.3(b)(13).  By contrast, “the determination as to which sanction was imposed” is not such an initial determination.  *Id.*; *see*42 C.F.R. § 488.408(g)(2) (a facility may not appeal CMS’s “choice of remedy, including the factors considered by CMS . . . in selecting the remedy”); *see also Alexandria Place*,**DAB No. 2245 at 27; *Kenton Healthcare,*DAB No. 2186 at 28.

CMS decided to impose per-day CMPs in this case, and I have found that the declaration of immediate jeopardy was not clearly erroneous.  For the period of Petitioner’s immediate jeopardy level noncompliance (June 16 through July 23, 2019), CMS imposed a CMP of $7,267 per day, which is near the bottom of the range for immediate jeopardy level noncompliance.  For the period of Petitioner’s non-immediate jeopardy level noncompliance (July 24 through July 30, 2019), CMS imposed a CMP of $110 per day, which is almost the minimum amount for non-immediate jeopardy level noncompliance.  I next consider whether these CMP amounts are reasonable based on the regulatory factors.

Petitioner did not assert its financial condition justifies a reduction of the CMP amount.  Therefore, I need not consider this factor.  However, Petitioner argues that because it does not have a poor compliance history, I should reduce the CMP.  P. Post‐hrg. Br. at 20; P. Reply at 8‐9.

Petitioner points to a ProPublica page to support its assertion that it has not been cited with a Tag F689 deficiency or any other deficiencies above a scope and severity level of “F” since February 2017.  P. Post‐hrg. Br. at 20 (citing *Wynwood Rehabilitation and Healthcare Center*, ProPublica, https://projects.propublica.org/nursing-homes/homes/h-315047 (last visited March 6, 2023).  Petitioner’s own source supports that the facility has a prior history of noncompliance.  Further, even though Petitioner had not been cited with a deficiency at Tag F689 since February 2017, the regulations encompass *any* prior

**Page 22**

history of noncompliance and are not limited to repeated deficiencies or prior instances of specific cited deficiencies.  *See Alden Town Manor Rehab. & HCC*, DAB No. 2054 at 31 (2006) (citing 42 C.F.R. §§ 488.438(1), 488.404(c)(2)).  For these reasons, Petitioner has not met its burden of demonstrating that this factor supports a reduction of the CMP.  *See Brian Ctr. Health & Rehab./Goldsboro*, DAB No. 2336 at 12 (2010) (citing *The Windsor House*, DAB No. 1942 at 62 (2004)).

The scope and severity of the cited deficiencies supports the CMPs at issue.  The deficiency at Tag F689 was cited at scope and severity “K,” which represents a pattern of immediate jeopardy.  *See*CMS Ex. 1 at 11.  CMS argues that there was a pattern based in part on an undated Quality Assurance and Performance Improvement (QAPI) document titled “Elopement Prevention and Compliance.”  CMS Post‐hrg. Br. at 11 (citing CMS Ex. 3 at 1).  CMS contends this document demonstrates elopement is an ongoing issue at the facility and shows a pattern of elopements at the facility.  *Id*.  I do not find that CMS Ex. 3 proves that there is a pattern of elopements at Petitioner’s facility.  On the other hand, Petitioner acknowledges that the QAPI document reports two Wander Guard devices did not function when tested.  P. Reply at 8.  The QAPI document also identifies missing signatures on residents’ TARs as a concern.  CMS Ex. 3 at 1.  As I have described above, two more Wander Guard devices failed to function during the survey and the residents’ medical records reveal additional instances of missing signatures on the TARs.  I therefore find that CMS Ex. 3 is further evidence that Petitioner’s staff did not reliably check the function and placement of Wander Guard devices as ordered by the residents’ physicians and as prescribed in their care plans, and that these concerns had not been eliminated by the time of the survey.  I therefore find that Petitioner’s noncompliance was part of a pattern, which supports the amount of the CMPs.

Additionally, I find the severity of the deficiencies further supports the reasonableness of the CMPs.  As described above, Petitioner did not take reasonable and adequate measures to prevent elopements.  The facility acknowledged Resident 1 was at risk for wandering and elopement by placing a Wander Guard device on him.  Staff were also directed to monitor him closely.  Yet, Resident 1 was able to walk out of his room and the facility unbeknownst to staff.  Moreover, the record suggests Resident 1’s Wander Guard was not functioning properly on the night of his elopement.  Petitioner also failed to ensure the door alarm for the door through which Resident 1 exited was turned on.  It is apparent that an elderly, cognitively impaired resident, outdoors in an unfamiliar setting in the dark, would be exposed to risks of serious harm.  Resident 1 might have been struck by a car or fallen and injured himself, especially since he did not have his wheelchair.  Further, the non-functioning turnkey door alarm put any resident who might elope at risk for similar harm.  For these reasons, CMS appropriately cited the deficiencies as posing immediate jeopardy.  The fact that staff found Resident 1 unharmed does not diminish the seriousness of Petitioner’s noncompliance.

**Page 23**

Petitioner also failed to discover that two residents had nonfunctioning Wander Guard devices and failed to ensure the front door’s Wander Guard system operated properly.  Petitioner maintains that the Wander Guard system worked on the day of the survey.  P. Post‐hrg. Br. at 21; P. Reply at 8.  However, even accepting for purposes of argument that the front door lock operated as programmed, Petitioner has offered no plausible explanation for the fact that the door also failed to alarm when Resident 1 exited the facility.  Nor did Petitioner dispute that two residents’ personal Wander Guard devices did not work.  The inconsistencies in the Wander Guard system’s functioning placed all residents at risk for serious harm if they eloped from the facility unobserved.  Finally, even after Resident 1 had eloped, staff did not consistently check residents’ Wander Guards for function and placement.  Petitioner’s continued noncompliance shows neglect and disregard for resident safety.

Based on the factors discussed above, I find that CMPs near the very low end of the ranges for immediate and non‐immediate jeopardy noncompliance are more than reasonable.

**Duration:**  The parties’ arguments about the reasonableness of the CMPs focus on the amount of the CMPs; they make no specific arguments about the reasonableness of the proposed duration of the CMPs.  Petitioner does assert that any noncompliance is limited to the isolated elopement of Resident 1 and the Wander Guard system was functioning on the day of the survey.  P. Post‐hrg. Br. at 20‐21.  To the extent Petitioner intends to argue that the duration of the CMPs is unreasonable, the argument is without merit.

It is well-settled that once CMS has demonstrated a facility is not in substantial compliance with Medicare participation requirements, continuing noncompliance is presumed and the burden is on the facility to demonstrate it returned to substantial compliance earlier than the date alleged by CMS.  *Premier Living & Rehab. Ctr.*, DAB No. 2146 at 23 (2008) (“[O]nce a facility has been found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.”).

As I have already concluded, on the day of the survey, Petitioner remained out of compliance with the requirement to provide adequate supervision and assistance devices to prevent elopements.  Petitioner’s noncompliance constituted immediate jeopardy because it was likely that a resident who eloped would suffer serious harm, injury, or death.  Petitioner abated the immediate jeopardy on July 24, 2019; however, it was still out of compliance with Medicare participation requirements at the non-immediate jeopardy level.  CMS found that Petitioner returned to substantial compliance with Medicare participation requirements effective July 31, 2019.  CMS Ex. 2 at 1.  Petitioner presented no evidence that, should I find it noncompliant, it returned to substantial compliance prior to July 31, 2019.  Accordingly, I conclude that the duration of the proposed CMPs is reasonable.

**Page 24**

V. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2).  I further conclude that CMS’s determination of immediate jeopardy for the period of June 16 through July 23, 2019, was not clearly erroneous.  The $7,267 per‐day CMP from June 16 through July 23, 2019, and $110 per‐day CMP from July 24 through 30, 2019, are reasonable in amount and duration.

Endnotes

1  CMS and state survey agencies consider the scope and severity of deficiencies when selecting enforcement remedies. See 42 C.F.R. § 488.408. CMS summarizes the scope and severity levels in a matrix published in the State Operations Manual (SOM). CMS Internet Only Manual 100-07, chapter 7, section 7400.3.1, available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07pdf.pdf (last visited March 6, 2023). As relevant here, a scope and severity level of “K” indicates a pattern of immediate jeopardy to resident health and safety.

2  When citing the transcript, I refer to the page numbers printed at the upper right corner of the transcript pages and not to the PDF page numbers.

3  In what I assume to be a clerical error, both P. Ex. 7 and P. Ex. 8 are labeled as “P. Ex. 8” on each of the documents’ pages. I nevertheless refer to the exhibits as they are identified in the electronic file for this case. P. Ex. 7 appears at Docket Entry # 38a; P. Ex. 8 appears at Docket Entry # 38b.

4  My conclusions of law appear as headings in bold italic type. My findings of fact appear in the accompanying text.

5  In 2016, CMS issued a final rule that re-designated and revised the provisions of 42 C.F.R. Part 483. See Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688, 68,828 (Oct. 4, 2016). Prior to 2016, the content of subsections 483.25(d)(1) and (2) was codified at subsections 483.25(h)(1) and (2). The Meadowwood decision interpreted 42 C.F.R. § 483.25(h)(1) and (2), as did the other decisions cited in this paragraph. I find it appropriate to rely on the reasoning of these decisions in the present case because there was no substantive change to the language when 42 C.F.R. § 483.25(h)(1) and (2) were recodified as § 483.25(d)(1) and (2).

6  Wander Guard is a brand name for a security system that sounds an audible alarm when a resident wearing an electronic bracelet approaches or tries to exit through a door connected to the system. See Tr. at 26; see also Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 5 n.3 (2012).

7  BIMS scores are categorized into three levels: cognitively intact (13-15), moderately impaired (8-12), and severe impairment (0-7). See Long-Term Care Facility Resident Assessment Instrument 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score)), https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited February 21, 2023) (the cited material appears at page 168 of the PDF file).

8  Of note, Mr. Bak was present for the tests and originally suggested the sensor may not have been in the right position. CMS Ex. 8 at 4; Tr. at 33, 46, 47. He did not convey at that time that only a person wearing a Wander Guard could trigger the system.

9  The CMP ranges listed in the regulations are adjusted annually for inflation under 45 C.F.R part 102. The amounts I cite here were those in effect at the time CMS imposed the remedies at issue in the present case. See 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018). The inflation adjustment for 42 C.F.R. § 488.408(e)(1)(iii) lists the upper range of CMPs as $6,525 to $21,393, while the inflation adjustment for 42 C.F.R. § 488.438(a)(1)(i) lists the range as $6,524 to $21,393. Id. Similarly, there is a $1 discrepancy in the CMP amounts listed for the lower ranges. The drafters of the notice did not explain these discrepancies. In any event, the differences are not material to my decision.
  
          /s/
        Leslie A. Weyn

                      Administrative Law Judge Back to top
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