Vista Hills Health Care Center, CR6637 (2025)

DECISION

This case stems from an incident in which a resident, with a medical history including Alzheimer’s disease, and a known elopement risk, was able to walk out of Petitioner’s facility.  The resident, who required a walker to ambulate, opened both an exit door and an exterior gate prior to eloping from the facility undetected.  The resident was only found after falling in the facility’s parking lot and sustaining significant injuries.

Vista Hills Health Care Center (Petitioner or facility) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with Medicare program participation requirements at 42 C.F.R. § 483.25(d)(1)-(2) (free of accident hazards and adequate supervision/devices) and 42 C.F.R. § 483.90(d)(2) (safe operating condition of essential equipment).  Petitioner also challenges the imposition of a per-day civil money penalty (CMP) of $9,675 from May 15, 2022, to May 22, 2022, and a per-day civil money penalty of $245 from May 23, 2022, to May 25, 2022.

For the reasons discussed below, I affirm CMS’s determination.

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I.      Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at a SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, a SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because a SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements related to how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”1  42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.2

When a SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301.  To maintain “substantial compliance,” a SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

Broadly, noncompliance that subjects a SNF to enforcement remedies is divided into two levels.  One level is composed of deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C.

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§ 1395i-3(h)(1).  “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that a SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.3  See 42 C.F.R. § 488.404(a)-(b).

One such remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days a SNF is not in substantial compliance.  42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after March 17, 2022, for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,400 to $23,989 for per-instance CMPs; $120 to $7,195 per day for less serious noncompliance; or $7,317 to $23,989 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,111 (Mar. 17, 2022); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

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If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If a SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see 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).  If a SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on a SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

Either the SNF or CMS may request Departmental Appeals Board (DAB) review of an ALJ’s decision.  42 C.F.R. § 498.80.

II.      Background and Procedural History

Petitioner is a SNF that operates in El Paso, Texas.  On May 23, 2022, surveyors from the Texas Health and Human Services Commission (state agency) completed a complaint investigation.  CMS Ex. 2.  The state agency subsequently issued a Statement of Deficiencies (SOD).  Id.  The SOD concluded that the investigation into the complaint yielded evidence of substantial noncompliance with 42 C.F.R. § 483.25(d)(1),(2) (Tag F689) (i.e., free of accident hazards/supervision and assistive devices to prevent accidents) at a scope and severity level “J” (i.e., isolated deficiency constituting an immediate jeopardy to a health and safety) and 42 C.F.R. § 483.90(d)(2) (Tag F908) (i.e., requirement that the SNF maintain all mechanical, electrical, and patient care equipment in safe operating condition) at a scope and severity level of “K” (i.e., a pattern of deficiencies constituting immediate jeopardy to health and safety).  CMS Ex. 2.  The state agency also found noncompliance with 42 C.F.R. §§ 483.80(a)(1),(2),(4),(e),(f) (Tag F880) (i.e., requirement that facility maintain an effective infection prevention and

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control program) at a scope and severity level of “D” (i.e., isolated deficiency with no actual harm with the potential for more than minimal harm).4  Id.

On June 22, 2022, CMS imposed a CMP of $9,675 per day from May 15, 2022, to May 22, 2022, and a $245 per-day penalty from May 23, 2022, until further notice.  CMS Ex. 2 at 3-7.  CMS also advised that it was imposing a denial of payment for new admissions (DPNA), effective June 21, 2022; and termination of Petitioner’s Medicare provider agreement, effective November 23, 2022.  Id.  On September 8, 2022, CMS notified Petitioner that it had corrected its deficiencies and was in substantial compliance with Medicare requirements as of May 26, 2022.  Id. at 1-2.  Therefore, CMS imposed a civil money penalty of $9,675 per day from May 15, 2022, to May 22, 2022, and a $245 per-day penalty from May 23, 2022, until May 25, 2022.  Id.  CMS also rescinded the termination and DPNA.  Id.

On August 22, 2022, Petitioner timely requested a hearing before an ALJ.  On August 23, 2022, ALJ Bill Thomas issued an acknowledgment and Standing Prehearing Order (SPO) which directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.5  In compliance with the SPO, CMS filed an exchange, including a combined motion for summary judgment and prehearing brief (CMS Br.) and nine proposed exhibits (CMS Exs. 1-9), which included written direct testimony from two proposed witness.  Petitioner filed an exchange consisting of a prehearing brief and response to CMS’s motion for summary judgment (P. Br.), and objections to CMS’s exhibits (P. Objections).  Petitioner did not file any proposed exhibits, nor did it submit any direct testimony.

The SPO explained that a hearing would be necessary only if a party requested an opportunity to cross-examine a witness or witnesses for whom the opposing party submitted written direct testimony.  SPO §§ 11-13.  Neither party has requested an opportunity to cross-examine witnesses.6  Therefore, a hearing is unnecessary for the cross-examination of any witnesses, and the matter is ready for a decision on the merits.

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III.    Admission of Exhibits into the Record

Petitioner objected to CMS’s Exhibits 2, 6, 7, and 8.  P. Objections at 1-3.  As explained below, I overrule all objections and admit all of CMS’s proposed exhibits into the record.

Petitioner objects to the following proposed exhibits:  CMS Exhibit 2, CMS Form 2567, the Statement of Deficiencies (SOD) by the state agency; CMS Exhibit 6, surveyor notes; CMS Exhibit 7, the declaration of Silvia Aranda; and CMS Exhibit 8, the declaration of Rosa Maria Hinojos.  DAB E-File Doc. No. 7b at 1-3.

Petitioner objected to these documents, in whole or in part, on the basis that these documents contain hearsay and should be excluded.  Id.  Petitioner’s objections regarding hearsay evidence, however, are misplaced.  I am permitted to admit and consider hearsay statements in these administrative proceedings even if they would be inadmissible under the rules of evidence applicable to court proceedings.  See 42 C.F.R. § 498.61; Florence Park Care Ctr., DAB No. 1931 (2004).  The Board has recognized that hearsay statements “may be accorded appropriate weight, if supported by adequate indicia of reliability.”  Omni Manor Nursing Home, DAB No. 1920 at 16 (2004).  The weight an ALJ accords hearsay is “determined by the degree of reliability, based on relevant indicia of reliability and whether the hearsay is corroborated by other evidence in the record as a whole.”  Id. at 17.

Petitioner further objects to CMS Exhibit 2 on the basis that it is incomplete and to CMS Exhibit 6 as irrelevant, in part.  P. Objections at 1-3.  In these proceedings, I am to receive into evidence any testimony and documents that are relevant and material.  42 C.F.R. § 498.60(b)(1).  I may also receive evidence even if it is inadmissible under the rules of evidence applicable to the courts.  42 C.F.R. § 498.61.  Additionally, the Administrative Procedure Act provides: 

Any oral or documentary evidence may be received, but the agency as a matter of policy shall provide for the exclusion of irrelevant, immaterial, or unduly repetitious evidence.  A sanction may not be imposed or rule or order issued except on consideration of the whole record or those parts thereof cited by a party and supported by and in accordance with the reliable, probative, and substantial evidence.

5 U.S.C. § 556(d).  Therefore, the primary test for the admission of evidence is whether it is relevant and material to an issue in the case.  Both the SOD and surveyor notes are relevant and material to these proceedings as they form the basis and support for CMS’s findings of noncompliance.  The documents are therefore admitted and I will fully evaluate the evidence of record in this case when rendering a decision.

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Petitioner also objects to CMS Exhibit 7, on the basis that the declarant lacked clinical qualifications to conduct the survey as she is a licensed vocational nurse (LVN) rather than a registered nurse.  P. Objections at 2-3.  Contrary to Petitioner’s position, the survey at issue here, a complaint investigation, was not governed by the survey composition requirements at 42 U.S.C. § 1395i-3(g)(2).  Avon Nursing and Rehabilitation v. Becerra, 119 F.4th 286 (2d Cir. 2024); Avon Nursing Home, DAB No. 2830 (2017).  As the survey composition requirements do not apply here, I find no reason to exclude CMS Exhibit 7 on the basis that it was drafted by an LVN.

Therefore, I overrule Petitioner’s objections and admit all of CMS’s proposed exhibits into the record. 

IV.     Jurisdiction

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

V.       Issues

The following issues will be addressed in this decision: 

1)  Whether Petitioner failed to be in substantial compliance with the Medicare program participation requirements at 42 C.F.R. § 483.25(d)(1)-(2) and 42 C.F.R. § 483.90(d)(2);

2)  If the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) and 42 C.F.R. § 483.90(d)(2), whether CMS’s determination that the noncompliance immediately jeopardized the health and safety of the facility’s residents was clearly erroneous; and

3)  If Petitioner was not in substantial compliance, whether the amount of the CMP imposed on Petitioner is reasonable under the factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f). 

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VI.     Discussion

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) because it did not take all reasonable steps to ensure that Resident 1’s environment was as free of accident hazards as possible and that Resident 1, who was assessed as an elopement risk, was provided with adequate supervision and assistive devices to prevent her elopement from the facility. 7

Section 483.25, which governs quality of care, provides generally that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.”  Subsection 483.25(d) imposes specific obligations upon a facility to minimize accident hazards and prevent accidents, as follows: 

The facility must ensure that –

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

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

A number of appellate decisions of the DAB hold that the regulations require a facility to address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.”  Meadowwood Nursing Ctr., DAB No. 2541 at 2 (2013) (citing Me. Veterans’ Home – Scarborough, DAB No. 1975 at 10 (2005)).8  Subsection 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and

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assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”)).  Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision under all the circumstances.”  Windsor Health Care Ctr., DAB No. 1902 at 4 (2003), aff’d sub nom. Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

CMS alleges that Petitioner did not comply with 42 C.F.R. § 483.25(d) based on an incident in which a resident of Petitioner’s facility, identified as Resident 1,9 eloped from Petitioner’s facility and was injured.  CMS Br. at 14-16.  Because Resident 1 eloped undetected and was injured in a fall while outside of Petitioner’s facility, CMS determined that Petitioner failed to ensure that Resident 1’s environment remained as free of accident hazards as possible, and that Resident 1 received inadequate supervision and assistance devices to prevent accidents.  Id.  CMS further determined that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) posed immediate jeopardy to resident health and safety.  Id.at 18.

Petitioner does not dispute that Resident 1 eloped from its facility.  P. Br. at 6-7.  However, Petitioner argues that the facility appropriately assessed Resident 1’s risk of elopement and developed a care plan to address the risk.  Id. at 7.  Petitioner further states that it “correctly and consistently implemented” the care plan.  Id.

The weight of the evidence establishes that Petitioner did not comply substantially with 42 C.F.R. § 483.25(d).  Although Petitioner assessed Resident 1 as at risk of eloping and planned several interventions to prevent her from doing so, I find that Petitioner did not implement these interventions consistently and completely.  As I explain below, I find that, by failing to ensure its exterior gate and door alarms functioned properly, Petitioner did not take “all reasonable steps” to protect residents at risk for elopement.  See Briarwood, DAB No. 2115 at 11.  As such, Petitioner failed to “provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice.”  Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017) (internal quotation marks omitted).

1. Facts

I find the following facts by a preponderance of the evidence, based on my review of the entire record in this case.

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Resident 1.  At the time of the events at issue, Resident 1 was a 92-year-old woman with diagnoses of, among other things, Alzheimer’s disease, muscle wasting and atrophy, history of falling, schizophrenia, and anxiety disorder.  CMS Ex. 4 at 1-2, 7-10.  Resident 1 was initially admitted to Petitioner’s facility on September 11, 2019.  Id. at 1.  In relevant part, Resident 1’s care plan noted that Resident 1 had a cognitive impairment and was “at risk for a further decline in cognitive and functional abilities.”  Id. at 20.  The care plan also indicated that Resident 1 had impaired visual function and was “at risk for falls, injury, and a decline in functional ability.”  Id. at 22, 35-36.

On March 22, 2022, Petitioner’s staff completed an AHS-Elopement Assessment for Resident 1.  CMS Ex. 4 at 5-6.  Resident 1 received a score of 6, which indicated a “possible elopement risk.”  Id. at 5-6.10  The assessment indicated that Resident 1 had “reported/documented episodes of elopement and/or attempts to elope” and “signs of compromised decisional and substantially impaired judgement and/or physical status limitations that would place the resident at risk in the community.”  Id.  The assessment made the following behavioral observations regarding Resident 1:  “spends time on the first floor or wanders between floors or units;” “‘hangs around’ facility exits and/or stairways;” “verbalizes a serious/strong intent to leave the facility in the absence of an appropriate discharge plan;” “has the physical ability to leave the building;” “becomes agitated, confused and/or disoriented or displays consistently poor judgement (i.e., would not be able to safely care for him/herself outside of the facility);” and “engages in theme behavior (i.e., leaving for work, seeking his/her car, searching for children, seeking people/places from days/years gone by).”  Id.  The assessment concluded that Resident 1 was “[a]t risk to elope and should be placed on the Elopement Risk Protocol.”  Id.

Based on this assessment, Resident 1’s care plan was updated to include an entry for wandering and exit seeking.  CMS Ex. 4 at 32.  The care plan added language noting that Resident 1 “wanders related to cognitive impairment and is at risk for injury.”  Id.  The care plan included interventions such as “verbal cues for redirection to dissuade exit seeking behaviors,” and “check for proper functioning of the [Wander Guard11] audible alarm system and PRN as ordered.” Id. at 31.  Resident 1’s physician orders were also updated on March 23, 2022 (with a start date of April 15, 2022), to include an order to

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check her Wander Guard to left wrist and wheelchair “for placement and function every shift.”  Id. at 12.

Events of May 15, 2022.  The evidence establishes the following timeline of events related to Resident 1’s elopement.  Around 11:30pm, Resident 1 exited Petitioner’s facility while ambulating with a walker.  CMS Ex. 2 at 5-6.  Resident 1 walked out of the facility’s exit door in the A Hall and then walked out of a gate door in an enclosed area by the A Hall.  Id.  Upon exiting the facility, Resident 1 fell and struck her head and neck on the concrete parking lot.  Id. at 3.  Resident 1 was initially attended to by a passing motorist who had spotted her, stopped his vehicle, called emergency services, and sought assistance from the nursing staff.  CMS Ex. 6 at 33; see CMS Ex. 2 at 3, 22.

Resident 1 was thereafter transported by emergency medical services (EMS) to the emergency department at Del Sol Medical Center.  CMS Ex. 4. at 47-51.  Resident 1 arrived at the hospital at 11:56pm.  Id. at 47.  The medical report states that Resident 1 “[w]as found outside [Petitioner’s facility] by a pedestrian.  [Resident 1] fell and hit right side of forehead.  Nursing staff stated they did not know how she got out.”  Id.  The report further noted that Resident 1 had active head and neck injuries due to sustaining a fall on a concrete surface.  Id. at 19.  Following an evaluation, Resident 1 was admitted as an inpatient to the intensive care unit.  Id. at 52.  Diagnostic imaging of the head and neck showed a type 2 dens fracture of the cervical spine, fracture of the posterior C1 ring bilaterally, and a right front scalp laceration and hematoma.  Id. at 107-108.  Resident 1’s forehead laceration required approximately 20 sutures.  CMS Ex. 6 at 33.  A neurosurgical consultation recommended that the dens fracture be treated with a soft cervical collar and “no emergency neurosurgical intervention” was required.  CMS Ex. 4 at 99.  Resident 1 was also found to be COVID-19 positive upon arrival.  Id. at 94.

Survey Interviews.  Following a complaint, the state agency investigated the events involving Resident 1.  See generally CMS Exs. 2, 6.  The investigation revealed the following.  On the evening of May 15, 2022, Certified Nurse Assistant (CNA) A was working the night shift and assigned to Resident 1.  CMS Ex. 6 at 39; see CMS Ex. 2 at 5.  At approximately 10:40pm, Resident 1 was sleeping when CNA A entered her room to check her vital signs.  Id.  Around 11:15pm, LVN B observed that Resident 1, having been awaken by CNA A, “walked to the nurse’s station and asked for a snack.”  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  LVN B then walked Resident 1 “back to her room and stood by the door until she went back to bed.”  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.

LVN B left Resident 1 unattended and was in the restroom at approximately 11:30pm, when she heard an alarm ringing.  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  At that time, LVN B walked to Resident 1’s bed and realized she was not in the bed or in the room.  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  LVN B thereafter saw that the exit door in the A Hall of the facility was open but that its alarm was not ringing.  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  LVN B stated the alarm went off again after she pushed the door open.

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CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  Once she opened the door, she saw Resident 1 in the driveway near the facility’s sign.  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  By the time LVN B saw Resident 1 outside the facility, Resident 1 had fallen in the parking lot and struck the ground.  Id.  Resident 1 was being attended to by a passing motorist who had spotted her and called emergency services.  CMS Ex. 6 at 33; see CMS Ex. 2 at 3, 22.  Resident 1 had a cut that was actively bleeding when Petitioner’s staff arrived.  CMS Ex. 6 at 33.

The director of nursing (DON) stated that she was alerted of the elopement at approximately 11:30PM.  CMS Ex. 6 at 33.  The Administrator indicated that she was notified by the DON at approximately 11:49pm.  Id. at 46.  As soon as the DON and the Administrator arrived, they instructed the staff to perform a head count and to check all exits, emergency doors and gates.  Id.  The Administrator specifically stated that upon arrival to the facility we “[w]ent towards end of the hallway, checked the door to make sure it rang, when door was pushed it did ring, checked to see if it closed and make sure it locked.  Exited the building turned left towards gate, checked the gate was locked and was not opened.  DON put in code, exited then started looking through the path checking for a walker or any marks.”  Id. at 33.  The Administrator added that when they walked outside, they saw one of Resident 1’s shoes on a “second ramp [where] the pavement went down” before finding where she fell in front of the facility’s sign.  Id.  The Administrator also advised that Resident 1 “did have a w[a]nder guard, was easily redirected.  Would stand next to the door, because she had the wander guard when getting close to the door the wander guard ring which would scare her and would turn around.”  Id.  However, the Administrator also stated that only the entrance and dining room doors are equipped with wander guard alarms.  Id. at 48.

Aside from LVN B, no other members of Petitioner’s staff heard an alarm.  CNA A stated that at the time of the elopement, she was with another resident and did not hear any alarms.  CMS Ex. 6 at 39; see CMS Ex. 2 at 5.  LVN C was also working on the night of May 15, 2022.  CMS Ex. 6 at 40-41; see CMS Ex. 2 at 8.  LVN C worked in the D, E, and F halls of the facility.  CMS Ex. 6 at 40-41.  On the night of May 15, 2022, she did not hear any alarms going off indicating that an exit door was opened.  CMS Ex. 6 at 40-41; see CMS Ex. 2 at 7-8.  She first learned of Resident 1’s elopement when LVN B called seeking assistance.  CMS Ex. 2 at 7; CMS Ex. 6 at 40-41.  CNA P, CNA D, and CNA E all stated they did not hear any door alarms go off on the night of May 15, 2022.  CMS Ex. 6 at 40-41, 47; CMS Ex. 2 at 8, 10.  They all added that they were trained to immediately respond if a door alarm sounded.  Id.

On May 18, 2022, the state surveyor, along with the Administrator and Maintenance Director, inspected the facility.  CMS Ex. 6 at 42; CMS Ex. 2 at 9.  During the observation, they viewed the gate door which Resident 1 opened before falling in the parking lot.  Id.  The surveyor pulled and opened the door and “noted that [the] magnetic lock had not latched[,] and the gate door had opened without entering a code in the

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keypad.  The exit door was tested 3 more times and the Maintenance Director, and the surveyor [were] able to open the door without entering a code in the keypad.”  Id.  The Maintenance Director advised that “you must forcefully close the gate door so the magnet latches.”  Id.  The Maintenance Director further confirmed that only two doors in the facility have Wander Guard alarms, the front and exit door in the dining room, and that he checked the alarms weekly to ensure they were working.  Id.

The state surveyor also conducted an interview with the alarm technician.  CMS Ex. 6 at 49.  At the outset, the alarm technician advised that “I lied to you on Wednesday when I told you that when I had checked the door alarms/magnetic lock and keypad on the gated area on Hall A were all working properly.”  Id.  The alarm technician said he initially “wanted to protect [his] clients” but wanted to tell the truth after learning of Resident 1’s injuries.  Id.  The alarm technician advised that on Monday, May 16, 2022, he checked all the battery-operated exit door alarms/keypads and “found that the battery-operated door alarms on the resident halls were not being maintained according to manufacturer’s specifications.”  Id.  More specifically, he noted the products specify that the battery be changed two times per year.  Id.  However, upon inspection the batteries in the keypads were all dated July 2020.  Id.  The alarm technician also found “that the magnetic lock and keypad (on A Hall) had not been correctly installed and that was why the magnetic lock was not latching when the door was closed, and the door alarm was not ringing when the door was opened on May 15, 2022.”  Id.  Finally, the alarm technician showed the Administrator that the “door on the chain link fence outside by A Hall would open by pushing on the door without entering a code and the magnetic lock was not latching because they had not been installed correctly by the maintenance director.”  Id.  The alarm technician reattached the magnetic lock and installed two new keypads, one for the exit door in A Hall and the other for the gate door in the enclosed area by A hall.  Id.

2. Analysis      

As I explain below, I conclude, based on the facts I have found above, that Petitioner did not take all reasonable steps to ensure that Resident 1 received adequate supervision and assistance devices to mitigate the foreseeable risks of harm she faced when she eloped unobserved.

Petitioner contends that its care of Resident 1 substantially complied with 42 C.F.R. § 483.25(d).  Petitioner argues that it had appropriate protocols in place prior to the elopement, and properly assessed, care planned, and implemented appropriate interventions prior to Resident 1’s elopement.  P. Br. at 5.  Notwithstanding Resident 1’s actual elopement, Petitioner maintains that there is no evidence that its interventions were not properly and correctly implemented.  Id.

The issue here is not whether the facility took some steps to mitigate an assessed risk.  Rather, the issue is whether the facility took all reasonable steps to mitigate an assessed

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risk.  See Briarwood Nursing Ctr., DAB No. 2115 at 5.  The evidence establishes that the facility failed to “ensure” that Resident 1’s environment remained as free of accident hazards as possible, and that Resident 1 received adequate supervision and assistive devices to prevent accidents.  42 C.F.R. § 483.25(d).

While it is true that facilities have the flexibility to choose the methods used to prevent accidents, the chosen methods must still provide an adequate level of supervision under all circumstances.  See Heritage Plaza, DAB No. 2829 at 6; Windsor, DAB No. 1902 at 4.  Here, the evidence establishes Petitioner did not comply substantially with 42 C.F.R. § 483.25(d) because its supervision of Resident 1 and the assistive devices it employed were not adequate to mitigate the risks posed by Resident 1’s wandering and elopement behaviors.  Contrary to Petitioner’s arguments, several of the interventions Petitioner implemented were ineffective due to factors that were well within Petitioner’s ability to control.

The regulation does not require facilities to utilize the Wander Guard system or any other specific accident‑prevention method.  See Lifehouse of Riverside Healthcare Ctr., DAB No. 2774 at 15 (2017).  Rather, the regulation requires that, whatever methods the facility chooses, the methods are sufficient to ensure the safety of residents, particularly those who wander.  See 42 C.F.R. § 483.25(d)(1), (2).  Once a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents, the facility is required to follow through on them.  Lifehouse, DAB No. 2774 at 15. 

To address Resident 1’s risk of elopement, Petitioner’s care plan for Resident 1 included verbal cueing to redirect and dissuade exit-seeking behaviors and the use of a Wander Guard.  CMS Ex. 4 at 32.  In addition, Resident 1’s physician orders required that the Wander Guard on her left wrist and wheelchair be checked for functionality “every shift.”  CMS Ex. 4 at 12.  Petitioner also used a series of door alarms and battery-operated keypads.  CMS Ex. 6 at 48-49.  Petitioner therefore was required to ensure its system was adequate to prevent elopements.

At the outset, I note that Petitioner has not submitted any evidence, either documentary or testimonial, to support its position that its system was adequate.  Nor, has Petitioner provided any documentation showing that the care plan was followed.  More specifically, Petitioner has not submitted any evidence that its staff complied with the physician’s orders to check the functionality of Resident 1’s Wander Guard on every shift.

Additionally, Petitioner does not dispute that its Wander Guard system was only deployed on two doors in its facility.  Specifically, only the front entrance door and cafeteria exit door were setup to trigger an alarm if someone with a Wander Guard tried to elope.  CMS Ex. 6 at 42; CMS Ex. 2 at 9.  Thus, even though Resident 1 was provided with a Wander Guard device on her left wrist and wheelchair, the Wander Guard alarm

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would not be triggered if Petitioner attempted to exit from a different door in the facility.  Thus, it is apparent that these measures using the Wander Guard were only effective to mitigate the risk that a resident would elope through the front door and cafeteria door.  As such, the Wander Guard system was inadequate to prevent elopements from any of the facility’s other doors.

The other measures taken by Petitioner were likewise inadequate.  For the doors not equipped with the Wander Guard system, Petitioner relied on alarms and locks that did not work and failed to prevent Resident 1’s elopement from the facility.  In this case, Resident 1 was able to walk out of Petitioner’s facility undetected, while using a walker, and open two doors.  First, Resident 1 was able to walk outside of the facility after opening the side door in the A Hall.  CMS Ex. 2 at 4.  While the door was equipped with an alarm, the alarm’s length and sound failed to alert most of the staff.  In fact, numerous staff members including CNA A, LVN C, CNA P, CNA D and CNA E stated they did not hear any door alarms go off on the night of May 15, 2022, and were therefore not alerted to Resident 1’s elopement.  CMS Ex. 6 at 39-41; see CMS Ex. 2 at 5, 7-8, 10.  The only staff member who heard the alarm that evening was LVN B.  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  However, LVN B acknowledged that by the time she checked the door in the A Hall, the alarm was no longer sounding even though the door was still open.  CMS Ex. 6 at 40; see CMS Ex. 2 at 6.  Second, after exiting the facility through the A Hall door, Resident 1 was able to open another door in a gated area outside the building.  CMS Ex. 2 at 4.  While the facility door used a battery-operated keypad and magnetic lock, these too did not prevent Resident 1 from leaving Petitioner’s facility.  CMS Ex. 6 at 42; CMS Ex. 2 at 9.  Moreover, and as discussed below, they also failed to work properly.

As such, Petitioner failed to have adequate measures in place that provided Resident 1 with adequate supervision and assistance devices to prevent her elopement.  Here, Resident 1 was able to exit the facility and walk into the parking lot unsupervised.  Left to wander outside, Resident 1 fell onto the concrete and sustained injuries including a cervical fracture.  Significantly, Resident 1 was first noticed outside the facility, not by Petitioner’s staff, but by a passing motorist who called emergency services, and sought help from Petitioner’s nursing staff.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2).

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.90(d)(2) because it failed to maintain essential equipment in a safe operating manner to prevent the elopement of Resident 1.

42 C.F.R. § 483.90, which governs physical environment of SNFs, provides generally that “[t]he facility must be designed, constructed, equipped, and maintained to protect the health and safety of residents, personnel and the public.”  The regulation requires that, with respect to space and equipment, the facility must “[m]aintain all essential

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mechanical, electrical, and patient care equipment in safe operating condition.”  42 C.F.R. § 483.90(d)(2).  

Here, the state agency alleged in the SOD that Petitioner was not in compliance with this requirement because it failed to maintain exit door alarms and a gate alarm which were used to prevent the elopement of Resident 1.  CMS Ex. 2 at 20-21.  More specifically, the state agency found that Petitioner failed to ensure “the safe operating condition for 6 of 6 exit door alarms on resident hall[s] [and] 1 of 1 gate alarm in [the] enclosed area by A Hall.”  Id. at 21.

In reaching this conclusion, the state agency made a number of findings based on its interviews and observations of the facility.  See generally CMS Ex. 2.  These findings included that Petitioner failed to follow manufacturer’s specifications on the battery-operated door alarms in the A, B, C, D, E, and F Halls by not changing the batteries every six months.  CMS 5 at 49.  Notably at the time of the May 23, 2022 inspection, the batteries in the keypads were dated July 2020.  Id.  In addition, Petitioner failed to properly maintain the keypad lock on the gated fence outside of the A Hall.  CMS Ex. 2 at 29.  This failure was evidenced by Resident 1’s ability to leave the facility through this door as well as this door failing to properly lock during the state agency’s inspection.  Id.

Petitioner does not deny that the batteries were not updated or that the keypad lock failed to function properly on the gated fence.  See generally P. Br.  However, Petitioner argues that it substantially complied with the regulations because it “reasonably relied on the alarm technician [that it contracted with] to monitor and maintain the door alarms.”  Id. at 5.

Petitioner attempts to pass the blame on to the alarm technician are not persuasive.  At the outset, I note that Petitioner does not dispute that it hired the alarm technician and relied upon its services.  Additionally, the regulation squarely places the requirement on the facility.  42 C.F.R. § 483.90(d)(2).  While the facility has a right to determine how it complies with the regulations, it is the facility’s obligation to “[m]aintain all essential mechanical, electrical, and patient care equipment in safe operating condition.”  42 C.F.R. § 483.90(d)(2).  See also Fort Madison Health Ctr., DAB No. 2403 at 8-9 (2011) (“Whether a facility employs its own staff and equipment or contracts for services and equipment to provide care and services, the regulatory obligation to ensure safety remains with the facility.”); Springhill Senior Residence, DAB No. 2513 at 14 (2013) (observing that a “facility acts through its staff and cannot dissociate itself from the consequences of its employees’ actions”). 

Given that Petitioner does not challenge the underlying factual findings nor dispute that its systems were not in a “safe operating condition,” I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.90(d)(2) and that Petitioner has

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failed to show by a preponderance of the evidence that it maintained substantial compliance.

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

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

Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the facility to show that CMS’s determination is clearly erroneous.  Grace Healthcare of Benton, DAB No. 2189 at 13 (2008) (citing Liberty Commons Nursing & Rehab Ctr.-Johnston, DAB No. 2031 at 17-18 (2006), aff’d sub nom. Liberty Commons Nursing & Rehab Ctr. - Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007)).  The harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.”’  Maysville Nursing and Rehab., DAB No. 2874 at 21 (2018) (quoting Libertywood Nursing Ctr., DAB No. 2433 at 18 (2011), aff’d sub nom. Libertywood Nursing Ctr. v. Sebelius, 512 Fed. App’x 285 (4th Cir. 2013)).

As discussed in detail above, the evidence in this case establishes that Resident 1 eloped undetected from Petitioner’s facility.  CMS Ex. 2 at 5-6.  Following her exit from two of the facility’s doors, Resident 1 fell in the parking lot of Petitioner’s facility and sustained serious injuries.  Id. at 3.  Emergency personnel arrived at the scene and brought Resident 1 immediately to the emergency room (ER).  CMS Ex. 4. at 47-51.  Following examination and diagnostic testing in the ER, Resident 1 was diagnosed with a type 2 dens fracture of the cervical spine, fracture of the posterior C1 ring bilaterally, and a right front scalp laceration and hematoma.  Id. at 107-108.  Petitioner’s forehead laceration required approximately 20 sutures.  CMS Ex. 6 at 33.

Petitioner, however, argues that CMS’s determination of immediate jeopardy is clearly erroneous.  P. Br. at 7.  Petitioner states that:  1) “immediate action was not necessary to prevent the occurrence or recurrence of serious injury, harm, impairment or death to anyone;” 2) Resident # 1 was immediately located after she exited from the facility and

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provided emergency medical attention; and 3) “Petitioner had no reason to know or believe that the alarm technician would lie about the operational status of the door and gate alarms.” Id.

Having reviewed the evidence, I conclude that the finding of immediate jeopardy must be sustained because it was not clearly erroneous.  The evidence shows that there was actual serious injury and harm.  Resident 1 suffered a type 2 dens fracture of the cervical spine, fracture of the posterior C1 ring bilaterally, and a right front scalp laceration and hematoma which I consider to be serious injury, particularly given her age and medical history.  Moreover, even though the facility took some steps to address Resident 1’s elopement risk, the record calls into question whether the facility’s systems were working properly when she eloped.

As discussed above, Petitioner did not take all reasonable measures to provide adequate supervision and assistance devices to prevent elopements.  It failed to ensure its door alarms, magnetic locks, and Wander Guard systems operated properly and did not provide any documentation that it consistently checked Resident 1’s Wander Guard devices as ordered by the physicians.  These failures placed Resident 1 in a situation that caused serious harm.  Finally, while I acknowledge some internal inconsistencies in the alarm technician’s statements, Petitioner’s arguments are ultimately irrelevant because the regulatory obligation remains with the facility notwithstanding its decision to contract these services to another party.  See Fort Madison Health Ctr., DAB No. 2403 at 8-9.  See also Springhill Senior Residence, DAB No. 2513 at 14.

Accordingly, I find that CMS did not clearly err in concluding that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d)(1)-(2) and 42 C.F.R. § 483.90(d)(2) posed immediate jeopardy to the health and safety of Resident 1.

4. The penalties imposed are reasonable in amount and duration. 

In determining whether the CMP amount is reasonable, I must apply the following factors which are listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance, including repeated deficiencies; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

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The regulations leave the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2),498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2), (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  The Board has explained that “there is a presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS.  Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.”  Coquina Ctr., DAB No. 1860 at 32 (2002).  The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable.  Heritage Plaza Nursing Ctr., DAB No. 2829 at 22.

In assessing the reasonableness of a CMP amount, an ALJ considers the per-day amount, rather than the total accrued CMP.  See Kenton, DAB No. 2186 at 28 (2008).  Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404.  See, e.g., Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 19-20 (2010).  Because I sustained the finding of noncompliance at the immediate jeopardy level, the penalty amount for the first eight days of the period of noncompliance must be from the higher range of penalties.  42 C.F.R. § 488.438(a)(1)(i).  For the year in question, that range is $7,317 to $23,989 per day.  45 C.F.R. § 102.3 (2022); 87 Fed. Reg. at 15,100, 15,112 (March 17, 2022).  The lower per-day CMP range of $120 to $7,195, as adjusted annually, is also applicable to this case, because this range applies to deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or have 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); 87 Fed. Reg. at 15,100, 15,111.

Here, CMS imposed per-day CMPs of $9,675 from May 15, 2022, to May 22, 2022, and $245 from May 23, 2022, to May 25, 2022, which are reasonable.  The $9,675 amount, as well as the $245 amount, are at the lower end of the penalty ranges.  The evidence shows that CMS “considered [Petitioner’s] history, including any repeated deficiencies, its financial condition, and the factors specified in . . . 42 C.F.R. § 488.404.”  Id.

Petitioner argues that the total amount of the CMP is unreasonable because the facts fail to demonstrate any noncompliance.  P. Br. at 16.  However, I have determined that the facts before me support a finding of substantial noncompliance.  Thus, the issue before me is whether the regulatory factors were considered in setting the CMP amount and whether those factors support the CMP amount.  42 C.F.R. §§ 488.438(f), 488.404. Petitioner does not allege that a particular regulatory factor does not support the CMP amount.  See P. Br.

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Considering the factors, Petitioner’s noncompliance was very serious.  Petitioner’s failure to adequately supervise Resident 1 resulted in a serious injury, for which Petitioner is culpable.  Petitioner’s culpability is also significant because it failed to maintain essential equipment which ultimately failed to prevent Resident 1 from eloping and led to a serious injury.

Petitioner has not offered any argument or rebuttal to CMS’s evidence showing its history of noncompliance, nor has it made any argument that it cannot pay the per-day CMP.  I thus find no basis to reduce the CMP.  As a result, considering the regulatory factors here, I conclude that the CMP amounts imposed are reasonable.

VII.    Conclusion

For the reasons set forth above, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) and 42 C.F.R. § 483.90(d)(2) and that a per-day CMP of $9,675 from May 15, 2022, to May 22, 2022, and a per-day CMP of $245 from May 23, 2022, to May 25, 2022, are fully supported by the relevant statutory and regulatory factors in this case.