Marquardt Memorial Manor, DAB CR6671 (2025)

DECISION

Petitioner, Marquardt Memorial Manor, was not in substantial compliance with program participation requirements from March 13 through May 19, 2021, due to a violation of 42 C.F.R. § 483.25(d)(2).1  There is a basis for the imposition of a per day civil money penalty (CMP) $7,570 from April 12 through 19, 2021, and $435 for the period of April 20 through May 19, 2021.

I. Background

Petitioner is in Watertown, Wisconsin, and participates in Medicare as a skilled nursing facility (SNF). On April 21 and 22, 2021, life safety code and recertification surveys of Petitioner were completed by the Wisconsin Department of Health Services (state

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agency), and the state agency found Petitioner was not in substantial compliance with program participation requirements. Joint Stipulation of Undisputed Facts (Jt. Stip.) ¶ 2; Centers for Medicare & Medicaid Services (CMS) Exhibits (Exs.) 1-3. The state agency cited four violations of the life safety code that allegedly posed a risk for more than minimal harm with no actual harm or immediate jeopardy. CMS Ex. 1. The state agency cited eight violations of the requirements for participation of 42 C.F.R. Part 483, seven of which allegedly posed a risk for more than minimal harm without actual harm or immediate jeopardy, and one that posed immediate jeopardy to Petitioner’s residents. CMS Ex. 2. The state agency determined, regarding the alleged violation of 42 C.F.R. § 483.25(d), that immediate jeopardy began on March 13, 2021, and was removed on April 20, 2021. However, noncompliance continued that posed a risk for more than minimal harm without actual harm or immediate jeopardy. Jt. Stip. ¶¶ 3-4; CMS Ex. 2 at 18-19; CMS Ex. 3 at 1. On June 9, 2021, the state agency conducted a revisit survey and determined that Petitioner returned to substantial compliance with participation requirements effective May 20, 2021. Jt. Stip. ¶ 6; CMS Ex. 34 at 2.

On March 2, 2022, CMS notified Petitioner that it was imposing a CMP of $7,570 per day for eight days of immediate jeopardy from April 12 through 19, 2021, and $435 per day for noncompliance that did not pose immediate jeopardy from April 20 through May 19, 2021. CMS Ex. 34 at 1-2.

Petitioner requested a hearing before an administrative law judge (ALJ) on April 18, 2022. This case was assigned to me for hearing and decision on April 18, 2022, and my Standing Order was issued.

On July 18, 2023, a hearing was convened by video teleconference, and a transcript (Tr.) of the proceedings was prepared. CMS offered CMS Exs. 1 through 38, which were all admitted as evidence. Tr. 36. Petitioner offered Petitioner’s exhibits (P. Exs.) 1 through 17, and P. Exs. 1 through 10 and 12 through 17 were admitted as evidence. Tr. 36, 46. CMS called Surveyor Amy Pagel, RN, to testify (Tr. 56-116). Petitioner called the following witnesses: Elizabeth Brunner, RN, as an expert witness (Tr. 207-61; P. Ex. 14); Melissa Tews, RN, Petitioner’s Director of Nursing (DON) (Tr. 118-169) and Jennifer Johnson, Petitioner’s Executive Director (Petitioner’s administrator) (Tr. 169‑206).

The parties filed post-hearing briefs (CMS Br. and P. Br., respectively) on January 10, 2024, and reply briefs (CMS Reply and P. Reply, respectively) on February 9, 2024.

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II. Discussion

A. Applicable Law

1. Statutory and Regulatory Medicare Program Enforcement

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act 2  (Act) and 42 C.F.R. Part 483. Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.3 The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance. Act § 1819(h)(2)(C). The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA). Act § 1819(h)(2)(D). The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance. The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction. Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements. 42 C.F.R. §§ 488.400, 488.402(b). “Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301 (emphasis in original). A deficiency is a violation of a

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participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. Part 483, subpart B. 42 C.F.R. § 488.301. The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm. 42 C.F.R. § 488.301. Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10‑.28, 488.300-.335. The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements. 42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements. The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. On March 2, 2022, when CMS made the initial determination in this case, CMS was authorized to impose a CMP in the upper range of $7,317 per day to $23,989 per day for deficiencies that posed immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.4 42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2022). “Immediate jeopardy means a situation in which 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 (emphasis in original). CMS could impose a CMP in the lower range of CMPs ($120 per day to $7,195 per day) for deficiencies that did not pose immediate jeopardy, but either caused actual harm to residents, or caused no actual harm but had the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2022).

Petitioner was notified in this case that it is ineligible to conduct a nurse aide training and competency evaluation program (NATCEP) until April 22, 2023. CMS Ex. 3 at 3-4; CMS Ex. 34 at 4. Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program. Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was

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tasked to develop requirements for approval of NATCEPs and the process for review of those programs. Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set. The Secretary promulgated regulations at 42 C.F.R. Part 483, subpart D. Pursuant to 42 C.F.R. § 483.151(b)(2)(iv) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been: (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $11,995 (45 C.F.R. § 102.3 (Table)) (2022); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management. Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements. “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. §§ 483.10, 483.12, 483.24, 483.25, 483.40, 483.45, 483.70 or 483.80, which are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm. 42 C.F.R. § 488.301. The extended survey triggered by the state agency finding of substandard quality of care based on violation of 42 C.F.R. § 483.25, and the total CMP proposed by CMS trigger the ineligibility to be approved to conduct a NATCEP in this case. Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose. 42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination). Petitioner informed me at hearing that it does not challenge the CMP based on the noncompliance that was not cited as posing immediate jeopardy and agreed that the total CMP imposed based on that noncompliance is large enough to cause Petitioner to be ineligible to conduct a NATCEP. Tr. 23-27. Accordingly, there is no issue that ineligibility to conduct a NATCEP is triggered in this case.

2. Limited Right to Review of a Determination to Impose an Enforcement Remedy

The Act and regulations give long-term care facilities against which CMS has imposed an enforcement remedy the right to a hearing before an ALJ. Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13). However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of

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the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training and competency evaluation program. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

3. Burden of Proof, Burden of Production, and Quantum of Evidence

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.” Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted).

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.5 Rather, the Board has

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long held that the petitioner, i.e., the nongovernmental party, bears the ultimate burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense. Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, 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); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).

The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance. If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense. Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007). The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing. The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.” Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904. “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8th ed. 2004). One might conclude that if a preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing; i.e., CMS must present evidence sufficient to establish a fact as more likely true and to raise a presumption, subject to being disproved or rebutted. However, the Board has never specifically ruled that CMS must support its prima facie case by preponderant evidence, or what happens if it has not, including whether the burden shifts to Petitioner or not. It is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.

I conclude that CMS made a prima facie showing of noncompliance in this case. Petitioner has not rebutted the CMS prima facie showing of noncompliance.

B. Issues

Whether there is a basis for the imposition of an enforcement remedy; and, if so,

Whether the remedy imposed is reasonable.

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis. I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision. I discuss the credible evidence given the greatest weight in my decision-making.6 I also discuss any evidence that I find is not credible or worthy of weight. The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ. There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so. Charles H. Koch, Jr., Admin. L. and Prac. §§ 5:64 (3d ed. 2013).

This case involves a recertification survey of Petitioner conducted by state agency surveyors from April 19 through April 22, 2021 (April 22, 2021 survey).7  CMS Ex. 2. The surveyors alleged that Petitioner violated 42 C.F.R. §§ 483.10(b)(3)-(7) (Tag F551,8

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scope and severity (s/s) D9 ); 483.12(c)(1), (4) (Tag F609, s/s D); 483.12(c)(2)-(4) (Tag F610, s/s D); 483.21(b)(1) (Tag F656, s/s D); 483.24(a)(2) (Tag F677, s/s D); 483.45(c)(3), (e)(1)-(5) (Tag F758, s/s D); and 483.80(a), (e), (f). CMS Ex. 2. All the foregoing Tags alleged violations that posed a risk for more than minimal harm without actual harm or immediate jeopardy, and for convenience they are referred to as the non-IJ Tags. The surveyors also alleged Petitioner violated 42 C.F.R. § 483.25(d) (Tag F689) and that the violation posed immediate jeopardy. CMS Ex. 2 at 18. In its March 2, 2022 initial determination, CMS imposed a CMP and did not state the CMP was based on only the alleged noncompliance under Tag F689. Rather, the initial determination is clear that the CMP imposed was based on all the alleged noncompliance cited by the April 22, 2021 survey. CMS Ex. 34 at 1-2; Tr. 23-25. Petitioner did not request a hearing related to any of the non-IJ Tags but limited its request for review to Tag F689 and the enhanced CMP authorized based on the citation of immediate jeopardy. RFH; Joint Statement of Issues Presented; Jt. Stip. ¶¶ 2, 9. Therefore, the non-IJ Tags are not disputed and may be considered bases for the lower range CMP imposed by CMS. Tr. 23-25.

Petitioner’s challenges before me are whether there was noncompliance under Tag F689 as alleged by the surveyors and CMS and whether the noncompliance posed immediate jeopardy to one of more of Petitioner’s residents. The surveyors and CMS allege that the immediate jeopardy began on March 13 and continued through April 19, 2021. CMS Ex. 2 at 18-19, CMS Ex. 3 at 1. However, CMS imposed a CMP in the higher range reserved for noncompliance that poses immediate jeopardy for only eight days, from April 12 through 19, 2021. CMS Ex. 34 at 2. Therefore, the issue is whether immediate jeopardy existed for at least eight days, not necessarily from April 12 through 19, 2021, or for the entire period alleged by the state agency. Petitioner advised me at hearing that

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if I did find there was immediate jeopardy, Petitioner does not challenge the reasonableness of the CMP, for either the immediate jeopardy noncompliance or the non-IJ noncompliance. Tr. 23-25.

1. Petitioner violated 42 C.F.R. § 483.25(d)(2) (Tag F689) in the case of Resident 12.
2. The violation of 42 C.F.R. § 483.25(d)(2) posed a risk for more than minimal harm.

a. Facts

The noncompliance at issue before me involves multiple elopements or attempts by Resident 12.

The terms “elope” and “elopement” are not defined in the Act or regulations governing long-term care facilities. A facility is required to provide adequate supervision for its residents to prevent accidents. 42 C.F.R. § 483.25(d). But how much supervision or the types or methods of supervision are not specified in the regulations. Therefore, these are issues of fact that must be determined based on the evidence of standards (local, national, or industry) in the record. CMS and Petitioner’s policies may be evidence of the standards to be applied in long-term care facilities. Perry County Nursing Ctr., DAB No. 2555 at 9 (2014) (presumption facility policies reflect professional standards and surveyor testimony may also be evidence of professional standards if surveyor has training, experience, and knowledge). The evidence before me reflecting a national or industry standard includes an extract from the SOM. According to CMS policy in the SOM an “[e]lopement occurs when a resident leaves the premises [of the SNF/NF] or a safe area without authorization (i.e., an order for discharge or leave of absence) and/or any necessary supervision to do so.” CMS Ex. 18 at 12.

CMS policy defines supervision or adequate supervision as follows:

“Supervision/Adequate Supervision” refers to an intervention and means of mitigating the risk of an accident. Facilities are obligated to provide adequate supervision to prevent accidents. Adequate supervision is determined by assessing the appropriate level and number of staff required, the competency and training of the staff, and the frequency of supervision needed. This determination is based on the individual resident's assessed needs and identified hazards in the resident environment. Adequate supervision may vary from resident to resident and from time to time for the same resident.

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CMS Ex. 38 at 3, 6.

Petitioner’s elopement prevention policy does not define elopement. The policy states interventions for residents prone to wander are to be implemented to maximize resident independence, safety, and well-being. Procedures include:

Interviews of knowledgeable parties about a resident’s history of wandering or elopement;

Completion of an elopement risk assessment at admission, quarterly, and when there is a change of condition;

Development and implementation of an interim plan of care if a resident is assessed at high risk for elopement;

Photographing an at risk resident and ensuring the photograph and identifying information are available to staff;

Development and implementation of a plan of care by the interdisciplinary team (IDT) addressing the risk for elopement for a high risk resident;

Sharing the care planned interventions with direct care staff;

Use of a WanderGuard® and monitoring if deemed necessary by the IDT;

The elopement care plan was to be reviewed whenever a risk assessment was performed; and

Staff were to be educated.

P. Ex. 17; Tr. 174-81. It has not been alleged by CMS that Petitioner’s policy is not consistent with national or industry standards related to elopement prevention or resident safety. Petitioner’s policy leaves the specific interventions to be implemented to protect residents from accidents related to elopements to the IDT.

Each resident has an IDT composed of the resident’s attending physician, a registered nurse responsible for the resident, a nurse aide responsible for the resident, a food and nutrition services staff member, and any other appropriate staff. The IDT prepares the resident’s comprehensive care plan and reviews and revises it as necessary after each assessment of the resident. The comprehensive care plan establishes the interventions the IDT considers necessary to meet a resident’s medical, nursing, and mental/psychosocial needs, consistent with resident rights including the right to refuse treatment. 42 C.F.R.

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§ 483.21(b). The IDT establishes the interventions, including measures for supervision and assistance devices, needed to protect a resident from accidental injury, including during an elopement.

The WanderGuard® device mentioned in Petitioner’s policy is a monitoring device that sounds an alarm if a resident approaches or tries to open a door with the WanderGuard® system installed. A WanderGuard® is arguably a form of supervision because even if staff may not have direct visual supervision of a resident, when the alarm sounds it helps staff identify that the resident is at an alarmed door so that staff may go there and give direct supervision. Tr. 246. There is no evidence that the alarm system in use at Petitioner had a delayed egress feature, i.e., that prevented or delayed a resident’s exit if the resident pushed on the door so that staff had a better chance of getting to the resident when the alarm was triggered.

Resident 12, a male, was 73 years old when he was admitted to Petitioner on January 22, 2021. Resident 12 was admitted to Petitioner after being hospitalized for three days due to a fall without injury but with complaints of neck and back pain. CMS Ex. 10 at 1; CMS Ex. 11 at 14; P. Ex. 8 at 14. On admission to Petitioner, Resident 12’s diagnoses included rhabdomyolysis (rapid breakdown of muscle with weakness), dementia without behavioral disturbance, chronic obstructive pulmonary disease, and a history of falls. He required limited assistance walking in his room and with transfers, was incontinent of bowl and bladder, had no teeth, had adequate hearing, and spoke clearly but his speech was nonsensical. CMS Ex. 11 at 1, 13; P. Ex. 8 at 1, 14. Nurse’s notes from January 22, 2021, at 12:52 p.m., reflect the results of an elopement evaluation, which is documented in CMS Ex. 4 and P. Ex. 2.

The elopement risk evaluation from January 22, 2021, does not contain scores reflecting Resident 12’s cognitive status. The evaluation indicates Resident had no history of elopement or attempted elopement from home or a facility. The form indicates Resident 12 “expressed the desire to go home, packed belongings to go home or stayed near an exit door.” CMS Ex. 4; P. Ex. 2. Petitioner’s Executive Director Johnson explained that Resident 12’s room was at the time of his admission near an exit door and that is what the January 22, 2021 nurse’s note and elopement risk evaluation reflected and not that Resident 12 had packed his bags and was ready to go. Tr. 191-92. The elopement evaluation shows that Resident 12 did wander, sometimes his wandering was goal directed and sometimes not. The evaluation also indicates that his wandering behavior was likely to affect his safety and well-being or the safety and well-being of others. It was determined that Resident 12’s wandering was not likely to affect the privacy of others. Finally, the question of whether Resident 12 was not accepting his situation was marked no. CMS Ex. 4; P. Ex. 2. The form notes a score of two and that Resident 12 was at risk to elope but the calculation of that score is not explained. CMS Ex. 4; P. Ex. 2. DON Tews testified that the score of two meant Resident 12 had the potential to wander but there was no or minimal elopement risk at the time of admission. She

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testified that if his score had been five, a WanderGuard® would have been placed on the resident. Tr. 120-21. She also explained that the numeric score was automatically calculated by Petitioner’s electronic records system, and she could not explain the calculation. Tr. 144-45, 147-50. It is concerning that neither DON Tews nor Executive Director Johnson could explain how the elopement risk assessment was calculated and expressed no concern that the calculation was done without apparent consideration of the resident’s cognitive status. Tr. 144-45, 147-50, 193-96. I cannot find that the elopement risk assessment was a reasonable assessment of Resident 12’s elopement risk without some evidence as to how the elopement risk score is calculated or that the impact of Resident 12’s dementia and level of cognitive functioning was considered. Petitioner’s expert witness, RN Brunner, conceded that the BIMS and CAM® scores could have impacted the elopement risk assessment. Tr. 257.

A fall risk evaluation shows that Resident 12 was always disoriented in three spheres, he had a history of one to three falls in the past three months, he was ambulatory and incontinent, he had balance problems while standing and walking and needed an assistive device. The form indicates a score of 14 and notes he was at risk for falls but the calculation of that score is not described. CMS Ex. 5; P. Ex. 3.

An undated document that CMS represents is from Resident 12’s Minimum Data Set (MDS) (CMS List of Proposed Exhibits) addresses Resident 12’s behavior. I infer that this document was extracted from Resident 12’s initial MDS done shortly after admission to Petitioner because it indicates that no prior MDS assessment had been done. CMS Ex. 6 at 3. The form shows that Resident 12 had wandering behaviors observed one to three days during the seven-day MDS assessment period. But the form indicates that the wandering during that period did not pose a risk to Resident 12 due to the presence of stairs or getting outside the facility. CMS Ex. 6 at 2-3.

Petitioner determined that physical therapy (PT) was necessary for Resident 12 due to deficits in bed mobility, ability to transfer, and gait. His deficits were caused by impaired strength, impaired balance, postural instability, decreased activity tolerance, and decreased safety awareness. He was assessed as at increased risk for falls. When he was admitted to Petitioner and assessed for PT, Resident 12 could walk 50 feet with a front wheeled walker. The PT goal at the end of therapy planned for March 4, 2021, was for Resident 12 to walk 150 feet with a front wheeled walker with standby assistance. CMS Ex. 10 at 1, 3-4. PT progress notes are not in evidence. A nurse’s note dated January 18, 2021, indicates that Resident 12 walked 15 feet with a two-wheeled walker and the assistance of one staff member. CMS Ex. 11 at 11; P. Ex. 8 at 11. A nurse’s note dated March 6, 2021, indicates Medicare coverage ended because Resident 12 met his rehabilitation goals. CMS Ex. 11 at 7-8; P. Ex. 8 at 7-8. The distance Resident 12 could walk with or without a walker and assistance in early March 2021, is not in evidence. But Resident 12’s original PT goal was for him to be able to walk 150 feet with a walker and assistance. Based on the fact he achieved his rehabilitation goal, I infer that at the

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end of PT in early March 2021, he could walk 150 feet with a walker and assistance. I also note that the evidence does show that when Resident 12 eloped on March 13, 2021, he was found approximately one-tenth of a mile (528 feet) from Petitioner’s facility. CMS Ex. 8; CMS Ex. 11 at 7; CMS Ex. 25; CMS Ex. 36; P. Ex. 8 at 7.

DON Tews reviewed Resident 12’s progress notes from January 22, 2021 through April 27, 2021. P. Ex. 8. She testified that she did not recall any exit seeking behavior of Resident 12 before his March 13, 2021 elopement. Tr. 123-24. But wandering behavior was noted and the impact of Resident 12’s dementia was apparent during the period.

A nurse’s note at 9:17 p.m. on January 22, 2021, records that Resident 12 had self‑transferred several times; he was found walking in the hallway without a walker; and he needed one-on-one monitoring. CMS Ex. 11 at 13; P. Ex. 8 at 13. Nurse notes from January 23 and 24, 2021, indicate that Resident tried to stand frequently and, when he did stand, he took off walking and had to be redirected. CMS Ex. 11 at 12-13; P. Ex. 8 at 12‑13.

A nurse’s note at 4:56 a.m. on January 31, 2021, show Resident 12’s whereabouts had to be monitored frequently because he was not using the call light. CMS Ex. 11 at 11; P. Ex. 8 at 11.

On February 25, 2021, just over a month after his admission to Petitioner, Resident 12’s ability to get around had improved. An MDS note was entered in his record that showed that Resident 12 was self-transferring and ambulating often. However, he remained a fall risk and was difficult to redirect at times. His cognitive deficit was noted to be severe to profound and he did not respond sensibly to simple questions. CMS Ex. 11 at 8; P. Ex. 8 at 8.

Resident 12’s Medicare coverage expired on March 5, 2021, because he met his rehabilitation goals. CMS Ex. 11 at 8; P. Ex. 8 at 8.

On March 13, 2021, at about 11:48 a.m., Resident 12 asked the certified nurse assistant (CNA) to cut his hair and trim his beard. Consent was obtained from Resident 12’s responsible party and he was given a haircut and beard trim. CMS Ex. 11 at 7; P. Ex. 8 at 7. Whether this was a sign Resident 12 was planning to leave Petitioner or whether he was able to plan his departure is not determinable.

On March 13, 2021, at 7:40 p.m., Licensed Practical Nurse (LPN) Rosenow was notified that Resident 12 was missing. CMS Ex. 11 at 7; CMS Ex. 36 at 1; P. Ex. 8 at 7. Petitioner’s staff completed a room-by-room search but was unable locate Resident 12 in the building. At 7:56 p.m., LPN Rosenow received a call from a citizen who informed her that Resident 12 was a block down the street from Petitioner’s facility. LPN Rosenow immediately went to the described location and found Resident 12 with two

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police officers. The police officers reported that they found Resident 12 on the ground complaining of hip and knee pain. Resident 12 was transported to the hospital for examination. P. Ex. 4 at 1; P. Ex. 8 at 7; CMS Ex. 11 at 7; CMS Ex. 36.

The incident report from the Watertown Police Department (WPD) indicates that an officer was dispatched at 7:36 p.m. on March 13, 2021, in response to a call from a citizen that she had found an elderly man (Resident 12) who had fallen on the side of the road. The WPD report indicates the officer arrived at the scene at 7:43 p.m. and found Resident 12 sitting in the citizen’s car. The citizen reported Resident 12 was complaining of hip and knee pain; he did not know where he was; but he knew his name. The fire department also responded to check Resident 12. The citizen called Petitioner and asked if they were missing a resident and LPN Rosenow arrived on scene shortly thereafter. Resident 12 was transported by ambulance to the hospital. The WPD report states that in the area that Resident 12 was found there were no uneven areas or potholes in the road. CMS Ex. 8. CMS placed in evidence without objection by Petitioner a document that shows the high temperature on March 13, 2021, was 57 degrees Fahrenheit and the low temperature was 20 degrees Fahrenheit. CMS Ex. 13 at 1. Surveyor Pagel alleged in the Statement of Deficiencies (SOD) that sunset was 5:59 p.m. on March 13, 2021. She also alleged, and it is not disputed, that she checked and Resident 12 was found about one-tenth of a mile from Petitioner’s facility, there is a river five blocks from the facility, and there is a highway three to four blocks from the facility. CMS Ex. 2 at 23; CMS Ex. 25.

Resident 12 was taken to the hospital on March 13, 2021, for further evaluation. Radiologic examination revealed that Resident 12 had an old ankle fracture. However, no injury related to his elopement was determined and he was returned to Petitioner. CMS Ex. 7 at 8; CMS Ex. 11 at 7; P. Ex. 5; P. Ex. 8 at 7. Counsel and DON Tews agreed at hearing that the evidence does not show that the ankle fracture identified by x-ray on March 13, 2021, was related to the elopement on that date. Tr. 161-62, 205.

Petitioner determined that Resident 12 was at “high risk” of elopement after his March 13 elopement. He was fitted with a WanderGuard® bracelet after his return to Petitioner’s facility from the hospital. CMS Ex. 11 at 7; CMS Ex. 15 at 2; P. Ex. 4 at 2; P. Ex. 7; P. Ex. 8 at 7; Tr. 126. A new care plan was created on March 14, 2021, addressing Resident 12’s risk for elopement. Interventions adopted included the WanderGuard®, providing reorientation, scheduling Resident 12 for regular walks and appropriate activity, and identifying if there was a time of day when wandering and elopement were most likely to occur. CMS Ex. 12 at 2, 15; Tr. 128.

DON Tews testified that nurse’s notes for Resident 12 showed that he exited the facility twice between March 13 and April 19, 2021, but he never got more than a few feet beyond the door. She opined that the WanderGuard® was protecting him adequately because the alarm sounded and staff responded. She testified that Resident 12 never managed to exit without the WanderGuard® sounding. Tr. 130-31.

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A nurse’s note dated March 14, 2021, at 9:34 a.m., shows that Resident 12 was sitting in his wheelchair at the nurse’s station for closer supervision. P. Ex. 8 at 6; CMS Ex. 11 at 6. This intervention was not listed in Resident 12’s care plan initiated on March 14, 2021, which include no intervention for one-on-one supervision at that time. CMS Ex. 12 at 2. A note on March 14, 2021, at 12:56 p.m., indicates that Resident 12 was also taken by wheelchair to the day room where he could be closely observed after a CNA saw him walking in his room without assistance. It was noted his WanderGuard® was in place. A nurse’s note at 8:45 p.m. indicates Resident 12 was wandering around the facility independently, his WanderGuard® was on his wrist but he frequently attempted to break it off. CMS Ex. 11 at 6; P. Ex. 8 at 6. Nurse’s notes between March 14 and 18, 2021, show that Resident 12 was up and walking at various times. CMS Ex. 11 at 5; P. Ex. 8 at 5. There are no nurse’s notes between March 17 and April 1, 2021. CMS Ex. 11 at 4-5; P. Ex. 8 at 4-5.

On April 5, 2021, Resident 12 attempted to exit the facility through the 300 Unit sunroom door at about 6:40 p.m. He did not get out but was between the doors according to the nurse’s note. The note does not indicate how Resident 12 was discovered and there is no mention of the WanderGuard®. CMS Ex. 11 at 4; P. Ex. 8 at 4.

On April 7, 2021, at about 10:44 a.m., Resident 12 was observed going out an exit door by the day room. His WanderGuard® did go off. Staff redirected Resident 12 back into the facility according to the nurse’s note. P. Ex. 8 at 4; CMS Ex. 11 at 4.

On April 12, 2021, at 2:34 p.m., a nurse’s note states that Resident 12 was noted to be exit seeking throughout the shift. When he went out the 100 Unit exit, staff was right behind him and brought him back into the building. CMS Ex. 11 at 4; P. Ex. 8 at 4.

On April 19, 2021, at 11:03 a.m., a nurse’s note indicates that a 100 Unit door alarm sounded (I infer the WanderGuard®) and in less than 10 seconds the speech therapist had Resident 12 back in the building. P. Ex. 8 at 3; CMS Ex. 11 at 3. DON Tews testified that this incident was separate from an elopement observed and recorded in the SOD by Surveyor Pagel. She testified the elopement observed by the surveyor was not added to the nurse’s notes because it would have been the subject of an incident report. Tr. 137‑39.

Surveyor Pagel states in the SOD that she observed Resident 12 leave the facility 100 Unit exit door later on April 19, 2021, at about 10:57 a.m. She states she saw Resident 12 push open the exit door, and the alarm sounded immediately. Resident 12 was wearing a short-sleeved shirt, pajama bottoms, and slippers. He was walking down the sidewalk in front of the facility, but no staff responded. Surveyor Pagel states in the SOD that at 11:00 a.m. she went to find staff to let them know. She met DON Tews who was

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responding to the alarm. Resident 12 was escorted back into the facility. The surveyor states that Resident 12 had gotten 122 feet from the exit door and just five feet from the nearest street. CMS Ex. 2 at 18, 25. The nurses’ notes in evidence do not mention this second elopement on April 19, 2021. CMS Ex. 11 at 3; P. Ex. 8 at 3. Surveyor Pagel testified consistently with her statements in the SOD that she observed Resident 12 elope on April 19, 2021. She testified that when the door alarm sounded it took DON Tews about three minutes to respond and then less than a minute, possibly 30 seconds, to get to Resident 12. She opined that it was 50 to 60 degrees that morning and Resident 12 should have been wearing a jacket or long sleeves and shoes other than slippers to go outdoors. She opined that staff should have responded immediately to the door alarm, which indicated that a resident was attempting to exit or had exited the facility where they could be subject to harm from falling or walking into the road. She testified that Resident 12 had dementia and was severely cognitively impaired with poor judgment and safety awareness. She opined that having eloped, Resident 12 was subject to falling, he might have been hit by a car when crossing the entrance to the parking lot, and he was subject to cold weather conditions. Tr. 59-79.

On cross-examination Surveyor Pagel explained that as a surveyor she could not intervene to aide Resident 12 and that she saw no other staff in the 100 Unit hall until she saw DON Tews. Tr. 82-83. Surveyor Pagel testified in response to my question that she drafted Tag F689 in the SOD, and that she intended to cite Petitioner for Resident 12’s elopement on March 13, 2021, and the subsequent elopements. She explained, regarding the March 13, 2021 elopement, that Resident 12 was assessed as at risk to elope, he had improved through rehabilitation, he had exit seeking behavior, and Petitioner’s interventions were inadequate. She opined that in January 2021 when Resident 12 was admitted to Petitioner, he was unable to elope but by his discharge from rehabilitation in March 2021, he had improved to the point that he could elope. She opined that Resident 12’s IDT should have developed an elopement care plan when Resident 12 became more mobile. Tr. 99-101. Surveyor Pagel agreed on cross-examination that it was not appropriate for the IDT to implement a WanderGuard® for Resident 12 before the elopement on March 13, 2021. Tr. 113-14.

DON Tews testified that on April 19, 2021, she was in her office with another surveyor and heard the alarm sounding. After about 30 seconds of the alarm sounding, she excused herself to assist staff or attend to the alarm. She met Surveyor Pagel in the hall who told her where Resident 12 had gone. She saw that Resident 12 was across the parking lot. She approached him slowly to avoid startling him. He was safe and walking on the facility sidewalk. Resident 12 walked with her back into the facility. She estimated that from the moment she heard the alarm only a minute or a minute and a half elapsed before she was with Resident 12. She admitted that the sidewalk on which Resident 12 was standing was next to the road that had a 15 mile per hour speed limit. She opined Resident 12 was not heading to the street, but rather he was following the sidewalk which would take him to another of Petitioner’s buildings. Resident 12 was not

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injured during the April 19, 2021 elopement. Petitioner implemented 15-minute checks following the April 19, 2021 elopement but the surveyors insisted on one-on-one supervision. She testified that one-on-one supervision can have and did have, in the case of Resident 12, negative effects such has hallucinations and paranoia. Tr. 131-35. DON Tews did not explain how she determined that Resident 12’s hallucinations and paranoia were attributable to one-on-one supervision rather than his dementia and that opinion is given little weight. It was also not established that DON Dews had the education, training, or experience to make the distinction.

DON Tews testified that Resident 12’s March 14, 2021 care plan included the intervention of supervised walks because he had a WanderGuard® in place and it was not safe for him to “ambulate independently outside the facility” due to his poor safety awareness. Tr. 154, 164-66. She testified, consistent with her prior written statement, that when Resident 12 eloped on April 19, 2021, it was 45 degrees and cloudy and Resident 12 was wearing a t-shirt. Tr. 166-67. DON Tews indicated in her statement dated April 19, 2021, that Resident 12 had been noted to be exit seeking and a service aide was monitoring him as he sat outside her office watching television. When she heard the WanderGuard® alarm off she went to look for Resident 12 and found him outside. DON Tews does not explain what happened to the service aide that was supposed to be monitoring Resident 12. She explained in her statement that Resident 12’s exit seeking was usually in the evening (referred to as sundowning) and it was not typical for him to exit seek in the morning, which is inconsistent with the fact the service aide had been assigned to monitor him. P. Ex. 16. Nurse’s notes for Resident 12 show that he eloped or attempted to elope in the morning, afternoon, and evening, and not as DON Tews testified, usually in the evening. To the extent DON Tews was suggesting that because Resident 12 usually attempted to elope in the evening it was not foreseeable he might try in the morning, her suggestion is not credible considering the contemporaneous nurse’s notes.

Petitioner’s Executive Director Johnson testified that when a resident is admitted the resident is assessed. If the resident is assessed as having exit-seeking behaviors a WanderGuard® is implemented. If there are no exit-seeking behaviors, no WanderGuard® is used. She testified that the goal is to use the least restrictive interventions in recognition of resident rights. Tr. 171-73. She opined that there was no change in Resident 12’s condition after admission on January 21, 2021, that required a new elopement assessment until his elopement on March 13, 2021. Tr. 175. To the extent Executive Director Johnson’s testimony may be construed to be that Resident 12’s IDT did not need to consider his improved ambulation in early March 2021 before the March 13, 2021 elopement, I reject that opinion. Resident 12 was known to wander, he was demented and had poor safety awareness, and when his walking improved it was foreseeable that he would eventually wander out the door. However, the IDT had to consider the evidence that existed prior to March 13, 2021, to gain the foresight necessary to develop interventions to minimize the risk for harm from Resident 12 eloping.

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Executive Director Johnson testified that Petitioner fulfilled all the requirements of its elopement prevention policy (CMS Ex. 17) and Petitioner was not cited because the policy was defective. Tr. 181-82. She testified that the surveyors required that Petitioner provide Resident 12 one-on-one supervision to abate the immediate jeopardy. Tr. 187‑88.

Petitioner’s care plan for Resident 12 in evidence lists 15-minute checks as an intervention that was initiated on April 19, 2021. CMS Ex. 12 at 15. The evidence shows that beginning about noon on April 19 through April 21, 2021, Petitioner’s staff was checking on Resident 12 every 15 minutes. CMS Ex. 14.

Despite 15-minute checks continuing, on April 20, 2021, at 6:22 p.m., a nurse’s note indicates that door alarms sounded on the 100 Unit. LPN Rosenow found Resident 12 standing on the sidewalk outside and brought him back into the facility. LPN Rosenow noted she used distraction and companionship to get Resident 12 back into the facility. The note indicates that 15-minute checks were in progress. The nurse’s note states that a bright yellow sign was put on the 100 Unit doors advising residents to stay inside. CMS Ex. 11 at 3; P. Ex. 8 at 3; Tr. 140. This elopement shows the minimal impact of the 15‑minute checks and supports the surveyor’s position that one-on-one supervision was appropriate. There is no evidence related to the effectiveness of the yellow sign.

Nurses’ notes on April 21 and 22, 2021, state that Resident 12 was observed on more than one occasion talking to the mirror in his bathroom with increasing agitation. When he was asked by the nurse if everything was okay, Resident 12 referred to the guy in the mirror and stated he was leaving. The nurse convinced Resident 12 to stay for dinner. The April 22, 2021 note states that 15-minute checks continued but not that Resident 12 was receiving one-on-one supervision. CMS Ex. 11 at 2-3; P. Ex. 8 at 2-3; Tr. 141-42.

Nurses’ notes from April 23, 2021, show that Petitioner’s staff was working on getting Resident 12 transferred to a geriatric psychiatric unit. CMS Ex. 11 at 2; P. Ex. 8 at 2. A nurses’ note dated April 27, 2021, indicated that Resident 12 was expected to return to Petitioner by the end of the week. CMS Ex. 11 at 1; P. Ex. 8 at 1.

A revisit of Petitioner’s facility was conducted on June 9, 2021. CMS Ex. 31. The state agency found that Petitioner was in substantial compliance as of May 20, 2021, because it implemented and completed its plan of correction. CMS Ex. 6; CMS Ex. 27.

Elizabeth Brunner, RN, testified as an expert witness on behalf of Petitioner. She is a registered nurse and licensed nursing home administrator who provides independent consulting services for long-term care facilities. She has experience teaching directors of nursing how to attain regulatory compliance. Tr. 208-11; P. Ex. 14. She opined that when Resident 1 was admitted to Petitioner on January 22, 2021, the score of 2 on his elopement assessment should not result in implementing the use of a WanderGuard® or

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one-on-one supervision. She explained that at admission Resident 12 could not walk more than about 15 feet and he did that with a wheeled walker. She opined that he did not have the ability to independently leave Petitioner when he was first admitted. Tr. 220-221. She opined it was not foreseeable that Resident 12 would elope on March 13, 2021. His Medicare rehabilitation care had expired, he learned he could not return to assisted living, and he seemed to have accepted he would remain at Petitioner. Given Resident 12’s cognitive functioning reflected in nurse’s notes, I find RN Brunner’s opinion that he accepted his situation is not credible as she testified to no basis for that opinion. RN Brunner testified she found nothing in the record indicating he would attempt to elope on March 13, 2021. Tr. 224-25. She opined Resident 12 suffered no actual harm on March 13, 2021. Tr. 226. She opined that the wandering care plan adopted for Resident 12 after the March 13, 2021 elopement was appropriate to keep him safe. Tr. 228. RN Brunner opined that the April 19, 2021 elopement was also unforeseeable. Tr. 230. She opined that the citation of immediate jeopardy was not appropriate because Resident 1 was on the therapeutic wandering sidewalk in front of Petitioner, and he was not at risk for serious harm, injury, or death. Tr. 236. I do not find credible RN Brunner’s opinions which are inconsistent with my finding and conclusions.

On cross-examination RN Brunner opined that Resident 12’s elopements on March 13 and April 19, 2021, were not foreseeable. Tr. 249. RN Brunner opined that when Resident 12 exited the facility unsupervised on April 5, 2021, he was wandering, and she would not call it an elopement because he did not seem to have a plan to elope. Tr. 250‑52. Despite her years of experience, I do not accept RN Brunner’s opinion that an elopement occurs only when a resident intends to elope. She cited no evidence of a national standard or standard of practice consistent with her opinion that a resident must intend to elope. Her opinion is also inconsistent with CMS policy, which I accept as some evidence of a national standard, that indicates an elopement occurs when a resident leaves a facility without authorization or necessary supervision and imposes no intent requirement. CMS Ex. 18 at 12. Furthermore, whether Resident 12 wandered or eloped out the facility doors on March 13 and April 19, 2021, or any of the days he exited the facility, is not an important distinction. In every instance, Resident 12 exited the facility building and he was unsupervised outside on March 13 and April 19, 2021. The lack of supervision in an environment Resident 12’s IDT considered unsafe is the critical fact.

My understanding of RN Brunner’s testimony on cross-examination is that when Resident 12’s ability to walk improved following rehabilitation which ended in early March 2021, he was still unable to verbalize who he was or where he was going when wandering. Therefore, when he could walk better, but was unable to understand he could not just leave the facility, the risk he would wander out the facility door increased and that was shown by the incident when he left the facility on March 13, 2021. Tr. 253. RN Brunner subsequently testified that when he was first admitted and assessed on January 22, 2021, Resident 12 had little incentive to want to leave Petitioner as he was there for rehabilitation followed, by return to his assisted living arrangement. She did not explain

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whether she thought Resident 12 was able to form the intent to elope prior to March 2021 but not after. Tr. 258-59. But I do not find the intent to leave and elope or leaving by wandering out the door is a distinction of any importance, except to the extent it could affect care planning and there is no evidence it did in this case. The real problem is Resident 12’s exiting Petitioner’s building without supervision as I advised the parties at the conclusion of the hearing. Tr. 267. I further note that RN Brunner did not explain how she determined Resident 12’s ability to comprehend or understand the plan for him at admission or later and I find the suggestion he did inconsistent with her testimony indicating he did not have the capacity.

RN Brunner attached significance to the fact that during the April 19, 2021 elopement Resident 12 was outside on a therapeutic walking path that would cause Resident 12 to return to a facility door. Tr. 214, 230, 236, 242-43, 260-61. Petitioner’s care plan recognized Resident 12 needed to walk outdoors but the care plan reflects that the IDT determined Resident 12 could walk outdoors only with supervision. The care plan did not provide Resident 12 could walk outside on the therapeutic sidewalk without staff supervision. CMS Ex. 12 at 2, 15. I do not second guess the IDT determination that Resident 12 needed supervision for safety when he left the building.

Based on the evidence before me, including the testimony of RN Brunner, I find that a WanderGuard® is a tool for supervision. If the WanderGuard® alarm is triggered, that intervention has served its limited purpose of notifying staff a resident is attempting to leave or has left the facility. The intervention that is required when the WanderGuard® alarm is triggered is for staff to respond and regain supervision of the resident. Tr. 246. It is the unsupervised period that poses the risk for harm with the risk for harm dependent upon the needs of the resident and environmental conditions outside the facility. I find Resident 12’s WanderGuard® worked and should have alerted staff during the elopement observed by Surveyor Pagel on April 19, 2021. However, staff failed to respond to the alarm until DON Tews responded. It was staff response to the WanderGuard® that was not effective to prevent Resident 12 from being unsupervised outside for as long as he was, whether that was a minute and 30 seconds or three to four minutes. The fact that staff did not respond may support an inference that all staff were busy. The fact that staff did not respond until DON Tews went to investigate, showed the limited effectiveness of the planned intervention of relying upon the WanderGuard® to summon supervision for Resident 12. When 15-minute checks were implemented on April 19, 2021, that intervention appeared to be effective. But on April 20, 2021, at 6:22 p.m. a nurse’s note indicates that door alarms sounded on the 100 Unit. LPN Rosenow responded promptly to the alarm and found Resident 12 standing on the sidewalk outside and brought him back into the facility. The nurse’s note indicates that 15-minute checks were in progress. CMS Ex. 11 at 3; P. Ex. 8 at 3; Tr. 140. The fact that 15-minute checks were in effect on April 20, 2021, may have ensured that staff was available to respond promptly to the alarm but had LPN Rosenow been busy with another resident or other work, Petitioner’s evidence does not show that other staff could or would have responded promptly to the

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alarm. Therefore, 15-minute checks and the WanderGuard® were potentially ineffective to ensure Resident 12 was not at risk for being unsupervised outdoors for a longer period absent clear direction to staff regarding who was to respond and how quickly. This problem was arguably resolved by the implementation of the very burdensome one-on-one supervision that DON Tews and Executive Director Johnson testified was required by the surveyors rather than the IDT.

Except as specifically noted, I find the testimony of Surveyor Pagel and Petitioner’s witnesses to be credible and entitled to weight.

b. Analysis

Surveyor Pagel alleged in the SOD that Petitioner violated 42 C.F.R. § 483.25(d)(2) because Petitioner failed to ensure that Resident 12 had adequate supervision to prevent accidents. CMS Ex. 2 at 18. More specifically, the surveyor alleged that Petitioner failed to ensure that Resident 12 did not repeatedly elope from Petitioner’s facility, which put Resident 12 at risk of accidental harm. The SOD alleged that immediate jeopardy began on March 13, 2021, and was removed on April 20, 2021. However, the deficiency continued to pose a risk for more than minimal harm without actual harm or immediate jeopardy while Petitioner was continuing to implement its action plan. CMS Ex. 2 at 18‑19.

The participation requirement at issue is established by 42 C.F.R. § 483.25(d) which provides:

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.

The Board has addressed the requirements of 42 C.F.R. § 483.25(d) in many decisions.

In Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation, DAB No. 3036 (2021), the Board provided a thorough summary of its interpretation and application of the regulation.

Section 483.25 obligates a facility to make “quality of care,” as described in the regulation, a fundamental principle applicable “to all treatment and care provided to facility residents.” “Based on the comprehensive assessment of a

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resident, the facility must ensure that residents receive treatment and care in accordance with . . . the comprehensive person-centered care plan” and “the resident’s choices.” Id. To that end, section 483.25(d)(1) (formerly section 483.25(h)(1)), . . . obligates a facility to provide a resident environment that is “as free of accident hazards as is possible.” This requirement “places a continuum of affirmative duties” on the facility. Maine Veterans’ Home - Scarborough, DAB No. 1975, at 6 (2005). A facility must identify and remove hazards, where possible, or where the hazard is unavoidable because of other resident needs, manage the hazards by reducing accident risks to the extent possible. Id. at 10; Meridian Nursing Ctr., DAB No. 2265, at 3 (2009), aff'd sub nom. Fal-Meridian, Inc. v. United States Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010). In accordance with, a facility must take “all reasonable steps to ensure that a resident receives supervision . . . that meet[s] his or her assessed needs and mitigate[s] foreseeable risks of harm from accidents.” Briarwood Nursing Ctr., DAB No. 2115, at 5 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)).

“[T]he federal requirements are based on an ‘outcome-oriented’ approach, in which the regulations establish outcomes facilities must achieve, but provide each facility with flexibility to select methods to achieve them that are appropriate to its own circumstances and needs.” Azalea Court, DAB No. 2352, at 9 (2010) (citing Virginia Highlands Health Rehab. Ctr., DAB No. 2339, at 5 (2010), citing Lake Mary Healthcare, DAB No. 2081, at 17 (2007)), aff’d, Azalea Court v. United States Dep’t of Health & Human Servs., 482 F. App’x 460 (11th Cir. 2012). Accordingly, the “failure to take measures that are reasonably necessary, under the circumstances, to achieve an outcome required by the regulation . . . to ensure that the resident environment remains as free of accident hazards as is possible and that residents receive supervision adequate to prevent accidents” may establish “noncompliance, even though the regulation does not specify the particular measures that the facility must or may take to achieve these outcomes.” Azalea Court at 9 (emphasis in original).

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To provide a resident “adequate supervision” consistent with section 483.25(d)(2), a facility has flexibility to choose how to supervise a resident “as appropriate to [its] circumstances and to employ reasonably necessary measures to comply with the regulation”; but, the measures chosen must be able to “reduce known or foreseeable accident risks to the highest practicable degree . . . .” Heritage Plaza Nursing Ctr., DAB No. 2829, at 6, 20 (2017) (quoting Century Care of Crystal Coast, DAB No. 2076, at 6-7 and Lifehouse of Riverside Healthcare Ctr., DAB No. 2774, at 15 (2017)); see also Windsor Health Care Ctr., DAB No. 1902, at 5 (2003) (supervision or other accident-prevention measures taken must be “adequate” “under all the circumstances”), aff’d Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005); Del Rosa Villa, DAB No. 2458, at 19 (2012) (whether a facility complied with section 483.25(h)(2) depends on whether it took all reasonable and practicable measures to identify, evaluate, and reduce or eliminate the foreseeable risk of an accident), aff’d, Del Rosa Villa v. Sebelius, 546 F. App’x 666 (9th Cir. 2013); Libertywood Nursing Ctr., DAB No. 2433, at 7 (2011) (“ensuring” adequate supervision involves identifying and minimizing safety risks), aff’d, Libertywood Nursing Ctr. v. Sebelius, 512 F. App’x 285 (4th Cir. 2013); Clermont Nursing & Convalescent Ctr., DAB No. 1923, at 21 (2004) (section 483.25(h)(2) requires a facility to eliminate or reduce a known or foreseeable “risk of accident to the greatest degree practicable”), aff’d,Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005).

A facility’s obligations under section 483.25 also includes [sic] furnishing the care and services set forth in its own resident care policies. Life Care Ctr. of Bardstown, DAB No. 2479, at 22 (2012) (citing cases), aff’d, 535 F. App’x 468 (6th Cir 2013); Life Care Ctr. of Tullahoma, DAB No. 2304, at 34 (2010) (the care and services required by section 483.25 include care and services called for by a facility’s resident care policy), aff’d, Life Care Ctr. Tullahoma v. Sec’y of United States Dept. of Health & Human Servs., 453 F. App’x 610 (6th Cir. 2011); Good Shepherd Home for the Aged, Inc., DAB No. 2858, at 12 (2018) (section 483.25 obligates a SNF to follow its own resident care

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policies). Indeed, “[o]nce 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 held to follow through on them.” Heritage Plaza, DAB No. 2829, at 20.

Logan Healthcare, DAB No. 3036 at 12-14 (footnote omitted and emphasis in original).

The Board has previously stated that 42 C.F.R. § 483.25(d) does not make a facility strictly liable for accidents that occur, but that the regulation does require that a facility take all reasonable steps to ensure that: (1) a resident receives supervision and assistance devices that meet his or her assessed needs; and (2) mitigate foreseeable risks of harm from accidents. Woodstock Care Ctr., DAB No. 1726 at 28-30. A facility is permitted the flexibility to choose the methods of supervision it uses to prevent accidents, but the chosen methods must be adequate under the circumstances. Whether supervision is “adequate” depends in part upon a resident’s ability to protect himself or herself from harm. Id. Based on the regulation and the cases in this area, CMS meets its burden to make a prima facie case if the evidence demonstrates that the facility failed to provide adequate supervision and assistance devices to prevent accidents given what was reasonably foreseeable. Alden Town Manor Rehab. & HCC, DAB No. 2054 at 5-12 (2006). An “accident” is an unexpected, unintended event that can result in injury of a resident. It does not include adverse outcomes that are a direct consequence of treatment or care provided in accordance with current standards of practice (e.g., drug side effects or reactions). Woodstock Care Ctr., DAB No. 1726 at 4.

Key points extracted from the Board decisions include:

• An accident is an unexpected, unintended event that can result in injury of a resident.
• 42 C.F.R. § 483.25(d)(1) requires that a facility ensure the resident environment is as free of accident hazards as possible by identifying and removing hazards when possible or, if an accident hazard is unavoidable, the facility must ensure accident risks are minimized to the extent possible.
• 42 C.F.R. § 483.25(d)(2) requires that a facility takes all reasonable steps to provide a resident supervision according to assessed needs to mitigate foreseeable risk of harm from accidents.
• A facility has flexibility to choose methods for supervising a resident consistent with facility needs and compliance with the regulations, but the

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methods chosen for supervision must reduce known or foreseeable accident risks to the highest degree practical.

• A facility’s failure to take measures reasonably necessary to ensure that the resident environment remains as free of accident hazards as is possible or to ensure residents receive supervision adequate to prevent accidents may be noncompliance though the regulation does not dictate actions a facility must or may take to satisfy the regulatory requirement.
• A facility is not strictly liable for accidents that occur, but a facility is required to show it took all reasonable steps to ensure a resident is given supervision adequate to meet assessed needs and mitigates a foreseeable risk for harm from an accident.
• Whether supervision is “adequate” requires consideration of a resident’s ability to protect himself or herself from harm.

The Board has recognized that compliance with and enforcement of 42 C.F.R. § 483.25(d) includes elements of foreseeability, flexibility, practicability, possibility, and reasonableness, consistent with the Board’s position that a facility is not strictly liable based on the occurrence of an accident.

As the Board explained in Logan Healthcare Leasing, a long-term care facility must assess a resident and then develop a care plan for the resident. The delivery of care and services to the resident is based on the care plan and any facility policies that direct the delivery of care and services to residents. Assessments, care plans, and policies must address identified risks for harm due to accidents that may be avoided and interventions to minimize the risk for harm by provision of adequate assistance devices and/or supervision. A facility’s failure to provide assistance devices or supervision identified by resident assessment, the resident care plan, or facility policy may be a violation of 42 C.F.R. § 483.25(d). And, if there is a risk for more than minimal harm, the violation is noncompliance for which an enforcement remedy may be imposed.

The Board’s prior decisions interpreting the regulatory requirements are persuasive and appropriately applied in this case. Based on the following, I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(d)(2) because the evidence shows that Petitioner failed to provide adequate supervision of Resident 12 when he eloped on March 13, 2021 and subsequently on April 19, 2021. I further conclude, based on the following, that CMS has made a prima facie showing that there was a risk for more than minimal harm to Resident 12.

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Petitioner knew when Resident 12 was admitted on January 22, 2021, that he wandered, sometimes goal-directed and sometimes not, and that behavior was likely to affect his safety. CMS Ex. 4; CMS Ex. 6 at 2-3; P. Ex. 2.

Petitioner knew that Resident 12 suffered from dementia, was disoriented, and had poor safety awareness. CMS Ex. 11 at 1, 12-13; P. Ex. 8 at 1, 12-14.

Resident 12’s IDT created no wandering or elopement care plan when he was admitted to Petitioner in January 2021.

Petitioner knew when Resident 12 was admitted that his mobility was limited, and he needed rehabilitation through PT to improve his mobility. A PT plan was developed to improve Resident 12’s mobility from walking 50 feet with a walker to walking 150 feet with a walker. CMS Ex. 10 at 1, 3-4.

Petitioner knew that Resident 12’s Medicare coverage ended on March 5, 2021, because he achieved his rehabilitation goals. CMS Ex. 11 at 8; P. Ex. 8 at 8. The evidence does not reflect how far Resident 12 could walk on March 5, 2021, but I infer based on the PT goal having been set at 150 feet with a walker, Resident 12 could walk at least that far. P. Br. at 13.10 Petitioner knew or should have known of Resident 12’s improved ability to walk.

Based on the evidence, it was foreseeable by about March 5, 2021, before Resident 12 eloped on March 13, 2021, that Resident 12, who liked to wander, who had poor safety awareness, and who was demented could wander out Petitioner’s door at some point. RN Brunner ignored the facts when she opined that she saw nothing in the record indicating Resident 12 would elope on March 13, 2021. She also opined that Resident 12 was happy or satisfied that he would be staying at Petitioner and had no reason to want to leave Petitioner. But she pointed to no evidence that supported that opinion and there is no evidence that she had or could have interviewed Resident 12. Tr. 224-25. RN Brunner’s opinions are supported only by her speculation and not accepted. Her opinion that the March 13, 2021 elopement was not foreseeable is rejected. P. Ex. 14 at 4 ¶ 17.

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Resident 12 eloped on March 13, 2021. CMS Ex. 8; CMS Ex. 11 at 7; CMS Ex. 36; P. Ex. 4 at 1; P. Ex. 8 at 7. Resident 12’s IDT developed a care plan to address Resident 12’s risk for wandering/elopement on March 14, 2021. The care plan provided for a WanderGuard®; scheduling a time for regular walks or appropriate activity; reorientation to surroundings; and identifying if there was a time of day when wandering or elopement was more likely. CMS Ex. 12 at 2, 15. DON Tews clarified at hearing that the scheduled walks or activities were, as a matter of policy, with staff supervision because Resident 12 had a WanderGuard® and it was not safe for him to walk outside the facility independently. Tr. 129, 153-54, 165. DON Tews identified as a possible risk that, if unsupervised, Resident 12 might not know how to get back in the facility. Tr. 164. She also agreed that he was unable to identify risks on his own. Tr. 165. The fact that Resident 12’s IDT required that his outdoor walks be supervised shows that Petitioner foresaw a risk for harm if Resident 12 was outside unsupervised. Considering the evidence of care planning for Resident 12, I reject as unsupported RN Brunner’s suggestion that it was acceptable for Resident 12 to be outside unsupervised due to the design of Petitioner’s campus. P. Ex. 14 at 4 ¶ 15.

DON Tews testified that Resident 12 exited the facility twice between March 13 and April 19, 2021, but he never got more than a few feet beyond the door. She opined that the WanderGuard® provide Resident 12 adequate protection because staff responded to each alarm. Tr. 130-31. Nurse’s notes in evidence are not entirely consistent with DON Tews testimony as three elopements or attempts are recorded. Resident 1 attempted to exit on April 5, 2021, about 6:40 p.m., but he was found between the doors. CMS Ex. 11 at 4; P. Ex. 8 at 4. On April 7, 2021, at about 10:44 a.m., Resident 12 was observed going out a door when the WanderGuard® alarm was triggered. CMS Ex. 11 at 4; P. Ex. 8 at 4. On April 12, 2021, at about 2:34 p.m., Resident 12 was noted to be exit seeking and when he went out the door, staff was right behind him and brought him back. CMS Ex. 11 at 4; P. Ex. 8 at 4. On April 19, 2021, I infer before the elopement witnessed by the surveyor (Tr. 137-39; CMS Ex. 2 at 24), the alarm sounded, Resident 12 was out the door, but the speech therapist brought him back in building. CMS Ex. 11 at 3; P. Ex. 8 at 3. The four incidents show that the interventions adopted by the IDT were not effective to determine when Resident 12 was most likely to elope; reorientation did not help Resident 12 know not to elope; and the WanderGuard® did not deter Resident wandering out a door. What was also clear from the incidents is that the WanderGuard® worked to alert staff, but preventing Resident 12 from getting outside unsupervised depended on staff responding quickly. Therefore, it was foreseeable that at some time, Resident 12 was going to get out, the alarm was going to sound, but staff would be unavailable to respond because they were working with other residents. I reject RN Brunner’s opinion that the April 19, 2021 elopement was not foreseeable. P. Ex. 14 at 4 ¶ 17.

On April 19, 2021, at about 10:57 a.m., the alarm sounded when Resident 12 left the building. Surveyor Pagel observed this elopement. The evidence shows that DON Tews

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responded to the alarm and there is no evidence of other staff responding. Tr. 82-83. Surveyor Pagel stated in the SOD that Resident 12 had gotten about 122 feet from the exit door and just five feet from the nearest street. CMS Ex. 2 at 18, 25; Tr. 59-79. The evidence shows that DON Tews may have left her office to respond to the alarm in about 30 seconds but according to Surveyor Pagel it took about 3 minutes and 30 seconds for Resident 12 to be under the supervision of DON Tews. Tr. 59-79. DON Tews testified that only about one minute to one and a half minutes elapsed between the alarm sounding and her providing Resident 12 supervision. Tr. 131-35. I need not resolve exactly how long it took as there is no dispute Resident 12 was outside the facility unsupervised and it took at least a minute and 30 seconds for DON Tews to respond and when she got to the door, she saw that Resident 12 was already across the parking lot. Tr. 131-35; P. Reply at 11. 15-minute checks were added to Resident 12’s wandering and elopement care plan and implemented on April 19, 2021. CMS Ex. 12 at 15; CMS Ex. 14. However, even with 15-minute checks Resident 12 exited the door again on April 20, 2021, at about 6:22 p.m. The alarm sounded and a nurse responded promptly and found him standing on the sidewalk outside the door. A bright yellow sign advising residents to stay inside was posted on the door but whether it had any effect is unknown. CMS Ex. 11 at 3; P. Ex. 8 at 3; Tr. 140.

The evidence does not show that Resident 12 suffered actual harm on account of any of the incidents. Surveyor Pagel indicated in the SOD that there was a risk for more than minimal harm and immediate jeopardy due to Resident 12’s elopements. She testified that during an elopement Resident 12 was subject to falling or being hit by a car and he was also exposed to cold weather conditions. Tr. 59-79; CMS Ex. 2 at 18-30. Surveyor Pagel’s testimony and the SOD are sufficient to satisfy the CMS prima facie showing of a risk for more than minimal harm.

CMS concluded that Petitioner removed or abated immediate jeopardy on April 21, 2021, when Petitioner implemented one-on-one monitoring for Resident 12 in addition to 15-minute checks. CMS Ex. 2 at 29.

The burden is upon Petitioner to rebut the CMS prima facie case or to establish an affirmative defense to excuse its noncompliance, by a preponderance of the evidence. Petitioner offers no affirmative defense but makes several arguments that CMS failed to make a prima facie showing. Petitioner fails to meet its burden to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. § 483.25(d)(2).

Petitioner’s two primary arguments are that: (1) Resident 12’s March 13, 2021 elopement was unforeseeable; and (2) it had implemented appropriate interventions to reduce the risks for harm associated with Resident 12’s April 19, 2021 elopement. P. Br. at 2. Petitioner’s arguments fail for the reasons already discussed, i.e., both elopements were foreseeable and the interventions may have been good but they were inadequate.

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Petitioner attempts to use Resident rights as a shield in this case. The gist of Petitioner’s argument is that it needed to implement the most minimally restrictive interventions to avoid violation of Resident 12’s rights. P. Br. at 15; P. Reply at 13. Resident rights are specified in 42 C.F.R. § 483.10. Petitioner also placed in evidence notices listing resident rights issued by the federal and state governments. P. Exs 12 and 13. There is no question that long-term care facilities face a difficult task in balancing resident rights against interventions necessary to ensure quality of life (42 C.F.R. § 483.24) and quality of care (42 C.F.R. § 483.25). Without doubt, the state agency and CMS take the position that Petitioner must achieve that balance. Indeed, the Act and the regulations require that Petitioner achieve the balance as it agreed to when enrolling in Medicare. In this case, the IDT failed to determine in early March 2021 whether Resident 12 required additional interventions to keep him safe considering his improved ambulation, dementia, lack of safety awareness, fall risk, and any other assessed risks. The IDT failed to create and implement interventions and Resident 12 eloped, arguably violating his rights to quality care and quality of life. On April 19, 2021, and on other days when Resident 12 got out unsupervised, he was unsafe and his right to quality of care and quality of life were also violated. The point is that Petitioner cannot be permitted to assert it failed to implement more effective interventions out of concern for not violating resident rights when failure to implement effective interventions is itself a violation of resident rights to quality care and quality of life.

I conclude that CMS made a prima facie showing of noncompliance under Tag F689 based on a violation of 42 C.F.R. § 483.25(d)(2) that posed a risk for more than minimal harm. Petitioner has not rebutted the CMS prima facie showing by a preponderance of the evidence that it was compliant with 42 C.F.R. § 483.25(d)(2), or that the violation of the regulation posed no risk for more than minimal harm. Petitioner has also not established an affirmative defense by a preponderance of the evidence.

3. The determination of immediate jeopardy related to the noncompliance based on violation of 42 C.F.R. § 483.25(d)(2) was not clearly erroneous.

The surveyors alleged that Petitioner’s noncompliance based on the violation of 42 C.F.R. § 483.25(d)(2) posed immediate jeopardy to Petitioner’s residents. CMS Ex. 2 at 18-30.

Petitioner argues that the declaration of immediate jeopardy was clearly erroneous. P. Br. at 17-29; Petitioner’s Proposed Findings of Fact and Conclusions of Law at 16-20. Petitioner argues there was no immediate jeopardy as there was no noncompliance with 42 C.F.R. § 483.25(d)(2). P. Br. at 18-25. I conclude this argument is without merit for the reasons already discussed. Petitioner is correct that Resident 12 did not suffer actual harm due to his elopements. But Petitioner concedes that actual harm is not necessary to

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support a declaration of immediate jeopardy. P. Br. at 19. Petitioner argues that it provided appropriate supervision for Resident 12 and there was no risk for serious harm to Resident 12. P. Br. at 18, 28-29. Prior to March 13 and 14, 2021, Petitioner had no care plan in place to address risks associated with Resident 12’s wandering and no plan that provided supervision that was necessary to mitigate risks for harm associated with Resident 12’s wandering. The use of a WanderGuard® for Resident 12 beginning March 14, 2021, was appropriate supervision but the WanderGuard® is not alone sufficient supervision. While the WanderGuard® might remind a more cognitively intact resident not to go out the door, Petitioner, who has the burden on this issue, has not shown the WanderGuard® had that effect with Resident 12. Petitioner has also failed to show that it had a plan for how to provide necessary staff supervision when staff was busy, and the alarm sounded. The IDT specified that when Resident 12 went outdoors to walk he required supervision. The testimony of DON Tews shows that supervision was necessary to provide for Resident 12’s safety. Therefore, Petitioner knew that it was unsafe for Resident 12 to be outside unsupervised. CMS does not have the burden to show that there were risks for harm that were serious. Rather, Petitioner must show that the risks for harm outdoors were not serious. For example, even if I accept that Petitioner’s therapeutic sidewalk presented no risk for serious harm, the proximity to the street and common knowledge that a human collision with a moving vehicle can cause serious injury, even at low speed, presents a serious evidentiary challenge for Petitioner. Petitioner acknowledges that being hit by a car at any speed poses a risk for harm. But Petitioner speculates that in broad daylight and at low speed, a car should be able to stop without hitting Resident 12 if he stepped into the street. P. Br. at 27. Petitioner’s speculation is no substitute for evidence. Even accepting the condition of broad day light and a 15 mile per hour speed limit, conditions of cars and drivers, sightlines, visibility of clothing, and many other factors would have to be considered to attempt to validate Petitioner’s speculation. Petitioner asserts that when Resident 12 eloped he remained in a safe area. P. Br. at 27. But Petitioner does not explain how that safe area was established or provided. Assuming drivers can avoid a collision in all circumstances, and assuming a demented resident will stay on a therapeutic sidewalk and not step into an adjacent street, are not reasonable assumptions. Indeed, the IDT did not make such assumptions when directing that when walking outside Resident 12 should be supervised. Similarly, on a fair day weather conditions may not pose a risk for serious harm, but if a demented resident is outdoors unsupervised during bad weather, the risk for serious harm may exist.

Petitioner bears a heavy burden under the regulations when challenging a determination of immediate jeopardy. Unlike the issue of whether there is noncompliance, the Secretary has by regulation imposed the burden of persuasion on Petitioner to show that the determination of immediate jeopardy was in error not by a preponderance of the evidence, but by a showing that the determination was clearly erroneous. The CMS determination of immediate jeopardy must be upheld unless Petitioner shows the determination of immediate jeopardy was clearly erroneous. 42 C.F.R. § 498.60(c)(2). CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has

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a heavy burden to demonstrate clear error in that determination. Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing 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)); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab Ctr. – Johnston, DAB No. 2031 at 18-19 (2006), aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnson v. Leavitt, 241 F. App’x 76 (4th Cir. 2007). “Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to show that that determination is clearly erroneous.” Cal Turner, DAB No. 2384 at 14-15 (citing Liberty Commons, 241 F. App’x 76, at 80-81).

“Immediate jeopardy” under the regulations refers to “a situation in which 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, 489.3 (emphasis in original). In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy. 42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d). The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management. 42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(ii).

Many appellate panels of the Board have addressed “immediate jeopardy.” 11 In Miss. Care Ctr. of Greenville, the Board commented:

CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous. 42 C.F.R. § 498.60(c)(2); Woodstock Care Center. The “clearly

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erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one. See, e.g.,Maysville Nursing & Rehabilitation Facility, DAB No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031, at 18 (2006), aff’d, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007). When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries.” 59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994). “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.” Daughters of Miriam Center, DAB No. 2067, at 15 (2007).

DAB No. 2450 at 15 (2012). The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations. In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however. As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries. Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior. Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which

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may vary from facility to facility. While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers. Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts. For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.

59 Fed. Reg. at 56,179 (emphasis added). It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration, by adopting the clearly erroneous standard of review. Thus, caution must be exercised to ensure that the Board’s decisions in Mississippi Care Center, Daughters of Miriam Center, and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard. Giving deference or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Center, that panel of the Board states that the clearly erroneous standard means that “the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.” DAB No. 2450 at 15. Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.” However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Center and other cases does not define the standard. The “clearly erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed. Black’s Law Dictionary 760 (8th ed. 2004). The United States Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedure Act (APA). The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more

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probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence. In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring); Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993). The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion. Consol. Edison Co. of New York v. NLRB, 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999). Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed. United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622. The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential. The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding. The Court also commented that the APA requires meaningful review.12  Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue. A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm. Dumas Nursing & Rehab., L.P., DAB No. 2347 at 19 (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58). The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define “likelihood” or establish any temporal parameters for potential harm. Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011). The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard. Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 7-8. There is a difference between “likelihood” as required by the definition of immediate jeopardy and a mere potential. The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential. Daughters of Miriam Ctr., DAB No. 2067 at 10. Jeopardy generally means danger, hazard, or peril. The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences may be. Woodstock Care Ctr., DAB No. 1726.

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What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301? How does serious injury, harm, or impairment compare with “actual harm?” On the first question, the Board recognized in Yakima Valley School, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy. DAB No. 2422 at 8. The Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.” Id. (citing Daughters of Miriam Ctr., DAB No. 2067 at 9). In Daughters of Miriam Center, the Board discussed that the ALJ attempted in that case to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening. The Board notes that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences. The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain. The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case. The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious. 13 Daughters of Miriam Ctr., DAB No. 2067 at 9-10.

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The Board has been consistent in its interpretation of the Act and regulations regarding immediate jeopardy. The declaration of immediate jeopardy is presumed to be correct. The burden is upon a facility to show that the declaration of immediate jeopardy is clearly erroneous. Therefore, the burden to show that there is no probability or that it is unlikely that there could be serious injury, harm, impairment, or death to a resident is Petitioner’s burden not CMS’ burden.

In this case, CMS determined that the noncompliance under Tag F689 based on violation of 42 C.F.R. § 483.25(d)(2) posed immediate jeopardy to Resident 12, and that immediate jeopardy began on March 13, 2021, and was ongoing until immediate jeopardy was removed on April 20, 2021. Based on my review of the record, I have not developed a definite and firm conviction that an error has been committed in the determination that there was immediate jeopardy. I conclude that Petitioner has not met its heavy burden to show the declaration of immediate jeopardy was clearly erroneous.

4. There is a basis for the imposition of an enforcement remedy.
5. A CMP of $7,570 per day for the period of April 12 through 19, 2021, and a CMP of $435 per day for the period April 20 through May 19, 2021, is reasonable.

If a facility is not in substantial compliance with program requirements, CMS is authorized to impose a CMP. CMS may impose a per day CMP for the number of days that the facility is not in substantial compliance. 42 C.F.R. §§ 488.408, 488.438. On March 2, 2022, when CMS made the initial determination in this case, CMS was authorized to impose a CMP in the upper range of $7,317 per day to $23,989 per day for deficiencies that posed 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); 45 C.F.R. § 102.3 (Table) (2022). CMS could impose a CMP in the lower range of CMPs ($120 per day to $7,195 per day) for deficiencies that did not pose immediate jeopardy, but either caused actual harm to residents, or caused no actual harm but had the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2022).

In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor. My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me. I am not bound to defer to the

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CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation as already explained. I am to determine whether the amount of any CMP proposed is within reasonable bounds, considering the purpose of the Act and regulations. Liberty Commons Nursing – Alamance, DAB No. 2070; Emerald Oaks, DAB No. 1800 at 10; CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

Petitioner had a history of noncompliance. Petitioner was cited for noncompliance by surveys in 2020, 2019, and 2018. Petitioner was also previously cited by two surveys with noncompliance under Tag F689 in 2019. The facts regarding the prior citations of noncompliance are not in evidence, however. CMS Ex. 35. Petitioner has not asserted that it is unable to pay the CMP proposed by CMS in this case. The noncompliance is serious. Resident 12 was unable to care for himself and being outdoors unsupervised posed a threat for serious harm, injury, or death. Resident 12 suffered no actual harm. Petitioner was culpable in that there is no evidence that the IDT considered whether Resident 12’s improved ambulation increased the risk that he would wander out the door without supervision. Petitioner also failed to plan for the circumstance when the WanderGuard® sounded and no one was available to respond promptly to ensure that Resident 12 had actual and direct supervision. Petitioner’s noncompliance had the potential to affect any current or future resident like Resident 12, i.e., a demented wanderer.

I also consider that the CMP of $7,570 per day is at the low end of the range for CMPs authorized for immediate jeopardy. The CMP of $435 per day is also at the low end of the range of CMPs authorized for non-IJ citations of noncompliance.

III. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. § 483.25(d)(2) and the violation amounted to noncompliance because it posed a risk for more than minimal harm. I further conclude that a CMP of $7,570 per day is reasonable for the period April 12 through 19, 2021, and a CMP of $435 per day is reasonable for the period April 20 through May 19, 2021.