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                              Maryville Nursing Home, DAB CR6207 (2022)
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Maryville Nursing Home, DAB CR6207 (2022)








  
  
    

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





Maryville Nursing Home,
(CCN: 385166),
Petitioner,

v.

Centers For Medicare & Medicaid Services.
Docket No. C-20-147Decision No. CR6207December 21, 2022

        
              
    

      DECISION

Maryville Nursing Home (Petitioner or the 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).  Petitioner also challenges the imposition of a per-instance civil money penalty (CMP) of $18,370 and that the cited noncompliance posed immediate jeopardy to resident health and safety.  For the reasons discussed below, I affirm CMS’s determination.  I conclude that Petitioner did not substantially comply with 42 C.F.R. § 483.25(d); that CMS’s finding of immediate jeopardy is not subject to review; and that the per-instance CMP imposed is reasonable.

I. Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Beaverton, Oregon, that participates in the Medicare program as a provider of services.  *See*CMS Exhibit (Ex.) 1 at 1.  Surveyors from the Oregon Department of Human Services (state agency) completed a survey of Petitioner’s facility on June 11, 2019.  *Id.*; *see also*CMS Ex. 2 at 1.  In a letter dated October 3, 2019, CMS informed Petitioner that, based on the state

**Page 2**

agency’s survey findings, CMS determined that Petitioner was not in substantial compliance with Medicare participation requirements and that the noncompliance represented an isolated episode of immediate jeopardy to resident health and safety (scope and severity level J).1  CMS Ex. 2.  CMS imposed a per-instance civil money penalty (CMP) of $18,370 based on its finding that Petitioner failed to comply with 42 C.F.R. § 483.25(d)(1), (2) (also identified as Tag F689), which requires facilities to be free of accident hazards and to ensure that residents receive adequate supervision and assistance devices to prevent accidents.  *Id.* at 1.  CMS also determined that, following a revisit survey, Petitioner returned to substantial compliance effective July 26, 2019.  *Id.*  Petitioner timely appealed and the case was assigned to me for a hearing and decision.

On December 13, 2019, my office acknowledged receipt of Petitioner’s hearing request and provided a copy of my Standing Prehearing Order (Prehearing Order).  Pursuant to the Prehearing Order, the parties submitted prehearing exchanges consisting of briefs (CMS Br. and P. Br.) and proposed exhibits, including the written direct testimony of proposed witnesses.  The Prehearing Order notified the parties that they must note objections to exhibits and request to cross-examine witnesses in the course of their prehearing exchanges.  Prehearing Order ¶¶ 7, 9.  CMS offered 13 proposed exhibits (CMS Exs. 1-13), including the written direct testimony of one witness (CMS Ex. 12).  Petitioner offered nine proposed exhibits (P. Exs. 1-9), including the written direct testimony of two witnesses (P. Exs. 8, 9).

CMS did not request to cross examine Petitioner’s witnesses.  Petitioner objected to CMS’s witness and requested to cross-examine in the alternative.  In an order dated

**Page 3**

March 16, 2021, I overruled Petitioner’s objection and granted Petitioner’s alternative request to cross-examine CMS’s witness.

On May 11, 2021, I convened a telephone prehearing conference with the parties, the substance of which is summarized in an order and notice of hearing issued May 18, 2021.  At the prehearing conference, the parties agreed to confer to resolve Petitioner’s objections to CMS’s Exs. 1-11.  Because I had overruled Petitioner’s objection to CMS Ex. 12, the written direct testimony of CMS’s witness, I scheduled the matter for a hearing to permit Petitioner to cross-examine the witness.

On August 24, 2021, I held a hearing via video-teleconference (VTC), and a transcript (Tr.) was made of the proceeding.  I presided from my office in the Washington, D.C. metropolitan area.  Counsel for each party and the witness appeared remotely from their respective offices.  Jeff Duncan, Esq., represented Petitioner.  Aaron Brown, Assistant Regional Counsel, represented CMS.  I admitted CMS Exs. 1-13 and P. Exs. 1-9.  Tr. at 9, 21.  During the hearing, counsel for Petitioner cross-examined Adrienne Binam who, at the time of the survey at issue, was a state agency surveyor.  Tr. at 21-65.  Following the hearing, the parties filed post-hearing briefs (CMS Post-hrg. Br.; P. Post-hrg. Br.) and post‐hearing replies (CMS Post-hrg. Reply; P. Post-hrg. Reply).

II. Issues

The issues in this case are:

Whether Petitioner was in substantial compliance with the requirements of 42 C.F.R. § 483.25(d)(1), (2) (Tag F689, relating to accident prevention and adequate supervision);

If Petitioner was not in substantial compliance, whether CMS’s determination that immediate jeopardy existed is subject to review and, if so, whether that determination is clearly erroneous; and

If Petitioner was not in substantial compliance with program requirements, whether the CMP imposed ($18,370) is reasonable.

III.  Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‐3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13), (b)(14)(i).

**Page 4**

IV. Discussion

**A. Statutory and Regulatory Background**

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

A facility must maintain substantial compliance with program requirements in order to participate in Medicare.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by sections 1819(b)-(d) of the Act (42 U.S.C. § 1395i-3(b)-(d)) or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  *Id.*  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  *Id.*

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  Among other enforcement remedies, CMS may impose a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.438(a)(2).  “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.  At the time of the June 2019 survey at issue in this case, the range for a per-instance CMP was $2,140 to $21,393. 42 C.F.R. § 488.438(a)(2) (as adjusted 83 Fed. Reg. 51,369, 51,380 (October 11, 2018)).2

If CMS imposes a remedy, such as a CMP, based on a noncompliance determination, then the facility may request a hearing before an administrative law judge to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy.  Act §§ 1128A(c)(2) (42 C.F.R. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 C.F.R. § 1395i-3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

**Page 5**

However, the facility may not appeal CMS’s choice of remedies.  42 C.F.R. § 488.408(g)(2).

CMS must make a prima facie showing that Petitioner failed to comply substantially with federal participation requirements.  If this occurs, Petitioner must prove substantial compliance by a preponderance of the evidence in order to rebut CMS’s showing and to prevail.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs.*, No. Civ. A 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998).

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

***Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) (Tag F689) because Petitioner did not take all reasonable steps to ensure that a resident who was assessed as an elopement risk was provided with adequate supervision to prevent accidents, namely her elopement from the facility.3***Section 483.25 of 42 C.F.R., which governs quality of care, provides generally that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the 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 Departmental Appeals Board (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.*

**Page 6**

*Veterans’ Home – Scarborough*, DAB No. 1975 at 10 (2005)).4  Subsection 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”  *Briarwood Nursing Ctr.*, DAB No. 2115 at 11 (2007) (citing *Woodstock Care Ctr. v. Thompson*, 363 F.3d 583, 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 (2003) (2003 WL 23142160 at *3), *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 3,5 eloped from Petitioner’s facility and was injured.  CMS Post-hrg. Br. at 1-2.  Because Resident 3 eloped undetected and was injured in a fall while off Petitioner’s premises, CMS determined that Petitioner failed to ensure that Resident 3’s environment remained as free of accident hazards as possible, and that Resident 3 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 12.

Petitioner does not dispute that Resident 3 eloped from its facility.  P. Post-hrg. Br. at 1.  However, Petitioner argues that that its interventions were adequate and compliant with the regulations.  *Id.*at 1-2.  Petitioner points out that there were appropriate protocols in place prior to the elopement, and that Resident 3 eloped despite those protocols.  *Id.*at 2.  Further, Petitioner argues that the finding of immediate jeopardy is clearly erroneous.  *Id.*at 10-11.

**Page 7**

The weight of the evidence establishes that Petitioner did not comply substantially with 42 C.F.R. § 483.25(d).  Although Petitioner assessed Resident 3 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 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 and citations omitted).

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

**Resident 3.**At the time of the events at issue, Resident 3 was an 82-year-old woman with diagnoses of, among other things, Alzheimer’s disease, dementia with behavioral disturbances, memory loss, and anxiety disorder.  CMS Ex. 5 at 3, 5; CMS Ex. 1 at 6-7.  Resident 3 had a language barrier, in that she spoke only Korean.  CMS Ex. 9 at 6.  The resident was admitted to Petitioner’s Memory Care Unit6 from her son’s home on January 3, 2019.  *Id.*  Resident 3’s family reported that the resident eloped from the home seven times in the past year.  *Id.*; *see also*CMS Ex. 5 at 3.  On one occasion, the family had to call police to help locate the resident.  CMS Ex. 9 at 6.

On January 3, 2019, one of Petitioner’s nurses completed a “Code Green Documentation Tool” containing Resident 3’s picture along with a description of her behavior.  CMS Ex. 3.  Petitioner refers to this document as the “Code Green sheet” for short.  *See, e.g.*P. Post-hrg. Br. at 4.  It is Petitioner’s policy to place the Code Green sheet at the front desk, to assist staff to recognize elopement-prone residents and prevent unsupervised departures.  P. Ex. 5 at 4; P. Ex. 8 at 4 (¶ 8).  The Code Green sheet described Resident 3’s known behaviors:

[Resident 3] [w]ill try to follow her family out after their visits.  Has paranoia and hallucinations which can trigger her to try to go out. . . . [Resident 3] heads for the exit doors, even when family is not present.  *May accidently follow staff or visitors out of the door*. . . . Has history of elopement from home [seven] times. . . . [Resident 3] has a Wanderguard on her right ankle, resident needs to be visually supervised when she decides to sit by the exit doors. . . .  Resident walks independently and can be very quick.

**Page 8**

CMS Ex. 3 (emphasis added).

Petitioner’s staff completed elopement risk assessments for Resident 3 on January 17 and 31, 2019.  *See* P. Exs. 2, 3.  In particular, the elopement risk assessments noted that Resident 3 exhibited restlessness, wandering, and exit-seeking behaviors.  P. Ex. 2 at 1-2; P. Ex. 3 at 1-2.  Similarly, as early as January 3, 2019, Resident 3’s care plan documented the following under the heading “Focus”:  “The resident is an elopement risk/wanderer [as evidenced by] [d]isoriented to place, [h]istory of elopement from home unattended, [i]mpaired safety awareness, Resident wanders looking for an exit.”  CMS Ex. 6 at 8, 9.  The care plan also documented that Resident 3 “[w]ill attempt to follow staff and visitors out the doors.”  *Id.*

Petitioner argues that the care plan entry warning that Resident 3 looked for exits and would follow staff and visitors out the door was added *after* the resident successfully eloped on February 10, 2019.  P. Post-hrg. Br. at 4-5; *see also*P. Ex. 8 at 4-5 (¶ 11).  Many of the entries in the care plan have multiple dates, including “Date Initiated,” “Created on,” and in some cases, “Revision on.”  As I read the care plan, the dates follow the entry to which they refer.  I therefore accept Petitioner’s argument about the timing of care plan entries, in part.  In the care plan, the phrase “Will attempt to follow staff and visitors out the door” is followed by an entry for “Revision on: 02/11/2019.”  CMS Ex. 6 at 9.  However, the phrase “Resident wanders looking for an exit” is followed by an entry for “Revision on: 01/10/2019.”  *Id.*  Moreover, as I have described above, on the date Resident 3 was admitted, Petitioner’s staff noted on the Code Green sheet that the resident may follow staff or visitors out the door.  *See*CMS Ex. 3.  I therefore find, by a preponderance of the evidence that, prior to Resident 3’s elopement on February 10, Petitioner’s staff were aware that the resident’s exit seeking behavior might include following staff or visitors out of the facility.

Resident 3’s care plan listed the following interventions to address her wandering behavior:  “Distract the resident from wandering by offering pleasant diversions, structured activities, food, conversation, television, book”; “Identify pattern of wandering: Is wandering purposeful, aimless, or escapist? Is resident looking for something? Does it indicate the need for more exercise? Intervene as appropriate.”  CMS Ex. 6 at 9.  These entries are dated as having been initiated and created on 01/03/2019.  *Id.* Additionally, effective the same date, the care plan listed the following intervention:  “Monitor [Resident 3’s] location every (Specify 15/30/60) min (Freq).  Document wandering behavior and attempted diversional interventions in behavior log.”  *Id.* at 10.  That care plan entry failed to specify whether staff should monitor Resident 3’s location at 15-, 30-, or 60-minute intervals, however.  *Id.*

**Page 9**

Petitioner also placed a Wanderguard7 device on Resident 3’s ankle on January 3, 2019.  *Id.* at 11; *see also*CMS Ex. 5 at 3.  Wanderguard is a security system that sounds an audible alarm when a resident wearing an electronic bracelet approaches or tries to exit through a door connected to the system.  *See*Tr. at 62.  In addition to the audible alarm, the system also transmits the location of the alarm to the nurse’s station in each unit.  CMS Ex. 5 at 9.  The doors to and from the Memory Care Unit are not programmed to the Wanderguard.  Tr. at 63.  The only doors that are equipped to trigger the Wanderguard are the exit doors of the main facility.8  *Id.*; *see also*P. Ex. 8 at 5 (¶ 13).

**Events of February 10, 2019.**  As Petitioner acknowledges, Resident 3 was able to exit its facility undetected on February 10, 2019.  P. Post-hrg Br. at 1.  The evidence establishes the following timeline of events related to Resident 3’s elopement.  At around 1:15 pm, one of Petitioner’s nurses (Y.K.) sent an email to maintenance that the Memory Care Unit door by the piano room was taking 15 to 20 seconds to latch, according to a visiting family member.  CMS Ex. 9 at 5.  Nurse Y.K.  directed the Certified Nursing Assistants (CNAs) on duty to watch Resident 3 and the door to the piano room since the lock was not latching.9  *Id*. At 1:35 pm, an activity staff member saw Resident 3 walking around the unit.  *Id.*  At 1:45 pm, a CNA saw Resident 3 standing around the common area.  *Id.*At 1:50 pm, Nurse Y.K. returned from lunch and saw Resident 3 walking around the unit.  *Id.*  The resident was last seen by staff “pacing around as usual” between 1:50 pm and 2:00 pm.  CMS Ex. 8 at 23; CMS Ex. 9 at 1.  At 2:00 pm, the Wanderguard alarm sounded at the exit door in the West Annex.10  CMS Ex. 9 at 5.  Nurse T.B. responded and checked the immediate area outside the door.  *Id.* She didn’t see anyone, so she turned off the alarm.  CMS Ex. 5 at 9.

At 2:45 pm, Nurse Y.K. stopped by Resident 3’s room to say goodbye to the resident before leaving work.  CMS Ex. 9 at 1.  Resident 3 was not in her room and Y.K. was unable to locate the resident anywhere in the Memory Care Unit.  *Id.* Nurse Y.K. reported to the front desk as well as the weekend manager that the resident was missing.  *Id*.  At 3:15 pm, the weekend manager notified police, Petitioner’s administrator, and the director of nursing.  *Id.*At 3:30 pm, police arrived at the facility and were given the

**Page 10**

resident’s information.  *Id.*  While the family and police were notified, staff checked the vicinity of the facility and volunteers initiated a search in the local area.  *Id.* at 5.  At around 4:00 pm, police found Resident 3 near the intersection of Murray Boulevard and Weir Road, which is at least two miles from the facility.  *Id.*at 6; *see also*CMS Ex. 5 at  5.  The weather in Beaverton, Oregon on the afternoon of February 10, 2019, was cold (around 37 degrees Fahrenheit) with snow showers.  CMS Ex. 13.

After police located Resident 3, they arranged her transport to the hospital by ambulance.  CMS Ex. 11 at 3.  The resident was seen in the emergency room at around 5:20 pm.  *Id.*at 1.  Records from the emergency room describe Resident 3 as having “injuries to her face . . . Left periorbital bruising . . . also bruising and tenderness of the right hand worrisome for fracture.”  *Id.* at 3.  An emergency room physician diagnosed the following:  1) closed displaced fracture of neck of fifth metacarpal bone of right hand; 2) closed displaced fracture of phalanx of finger of right hand; 3) traumatic injury of head; 4) facial contusion; and 5) injuries sustained as a result of a fall.  *Id.* The resident was discharged from the hospital back to Petitioner’s facility at or about 7:50 pm.  *Id.*at 4.

Resident 3 arrived back at the facility from the hospital at around 8:20 pm accompanied by family.  CMS Ex. 8 at 23.  A nurse documented that the resident had swelling and purple bruising around her right eye, an abrasion to the lateral side of her face, and a splint on her right hand.  *Id.*

**Petitioner’s investigation and subsequent actions.**  Data from the alarm panel showed that Resident 3 exited the building through a side door on the facility’s west corridor.  CMS Ex. 9 at 1.  Based on the facility’s investigation findings, Petitioner hypothesized that Resident 3 may have exited the Memory Care Unit through the door by the piano room.  *See* CMS Ex. 4 (floorplan); CMS Ex. 9 at 1.  Petitioner also theorized that the resident was able to elope by blending with visitors exiting the facility because she was well dressed, wearing a thick warm coat, and did not use any assistive devices while walking.  P. Ex. 8 at 2-3 (¶ 5); CMS Ex. 9 at 1.

After Resident 3 eloped, Petitioner’s staff revised the resident’s care plan to reflect that the resident “had an actual elopement from the facility” and that she “[w]ill attempt to follow staff and visitors out the doors.”  CMS Ex. 6 at 8.  Staff added several interventions, one of which specified that staff were to monitor Resident 3’s location every 15 minutes.  *Id.*at 9.  The care plan also directed staff to document wandering behavior and attempted diversional interventions in the behavior log.  *Id.*at 10.  Petitioner also initiated a 1:1 sitter for activities and close supervision.  *Id*at 11.  Petitioner also took action regarding its doors.  It hired a contractor to evaluate the door to the Memory Care Unit to ensure that it was functioning properly.  CMS Ex. 9 at 2.  Petitioner also decided to designate the doors outside the Memory Care Unit as fire exit doors (i.e. they are alarmed and are no longer used for routine entry and exit).  *See*P. Ex. 8 at 6 (¶ 14); P. Ex. 9 at 8 (¶ 15)).  Finally, Petitioner revised its elopement policy and

**Page 11**

trained its nurses on the alarm panels and how to respond when an alarm sounds.  CMS Ex. 9 at 2.

As I explain in the next section of this decision, I conclude, based on the facts I have found above, that Petitioner did not take all reasonable steps to ensure that Resident 3 received adequate supervision and assistance devices to mitigate the foreseeable risks of harm she faced when she eloped unobserved.

**Analysis**Petitioner contends that its care of Resident 3 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 3’s elopement.  P. Post-hrg. Br. at 2.  Petitioner points out that it correctly assessed Resident 3 as a wanderer and at risk for elopement, equipped her with a Wanderguard bracelet, and placed her in the locked Memory Care Unit.  *Id.*at 3.  Petitioner also provided activities for Resident 3 to distract her from wandering and keep her busy.  *Id.*  In addition, Petitioner asserts that its January 31, 2019 risk assessment showed that Resident 3 was “adjusting well” and had stated “[she] does not want to go out anymore.”  *Id.* at 4; *see also* CMS Ex. 9 at 6.  Furthermore, Petitioner mentions its use of the Code Green sheet, which contained a photo of the resident, as well as specific information to help mitigate elopement risks.  P. Post-hrg. Br. at 4.  Petitioner maintains that Resident 3 eloped, despite its compliance.  *Id.* at 2.11

I am not persuaded by Petitioner’s arguments.  The evidence shows that Petitioner failed to take all reasonable measures to protect Resident 3 from accidents and mitigate her foreseeable risk of elopement.  Although Petitioner makes much of its efforts to prevent Resident 3’s elopement, its arguments ignore or minimize the fact that its staff failed to implement effectively the measures Petitioner itself had determined were necessary to prevent Resident 3’s elopement.  As a result, Resident 3 eloped from the facility undetected at around 2:00 pm on February 10, 2019.

Petitioner attempts to minimize Resident 3’s elopement risk by suggesting that, as of the elopement assessment dated January 31, 2019, Resident 3 was “adjusting well” and “does not want to go out any more.”  P. Post-hrg. Br. at 3-4 (citing P. Ex. 8 [at 4] ¶ 7; P. Ex. 9 [at 5] ¶¶ 5, 9).  The January 31 elopement assessment does not include any such observation, however.  *See*P. Ex. 3.  Instead, the source of this assertion appears to be a

**Page 12**

comment in Petitioner’s investigation report compiled after Resident 3 eloped.  The investigation report documents that Resident 3 told Nurse Y.K., who speaks Korean, that she was happy at the facility and did not want to leave. 12  *See*CMS Ex. 9 at 6.  However, the same report goes on to state, “Although [resident] says she is happy here, she continues to wander around the unit and would head to the exit doors.”  *Id.*  The observation that Resident 3 continued her exit seeking behavior is consistent with the content of the January 31 elopement assessment, on which Petitioner’s staff checked boxes to indicate that Resident 3 displayed the following behaviors:  wandering, restlessness, hovering around exits, and seeking behaviors (looking for car, home, people).  P. Ex. 3 at 2.  These behaviors were unchanged from those identified in the elopement assessment of January 17, 2021.  *See*P. Ex. 2 at 2.

Similarly, Petitioner implies that Resident 3’s successful elopement by wearing a warm coat “to effectively blend in” with departing visitors was a new development.  P. Post-hrg. Br. at 4.  Petitioner’s own records undercut this assertion.  First of all, it appears Resident 3 often wore a padded jacket as part of her daily attire.  CMS Ex. 5 at 3, 6.  Second, and more importantly, it is clear that, from the time the resident was admitted to the facility, Petitioner’s staff were aware that she might attempt to exit by following family or visitors out.  *See*CMS Ex. 3; *see also*CMS Ex. 5 at 3 (Resident 3 “hovers around near exit and vocalizes to leave”).  Further, although there are relatively few chart notations regarding Resident 3’s wandering prior to her elopement, those that are in the record support the conclusion that her wandering and exit seeking were a consistent feature of her behavior.  *See e.g.,*CMS Ex. 5 at 4 (1/12/19 note stating, “resident is still seeking exit”; 1/14/19 note stating Resident 3 was “up wandering around unit . . . exit seeking, needed re-directed from the piano area . . . .”).  That is precisely what happened on February 10.  I am therefore not persuaded by Petitioner’s implication that Resident 3’s exit seeking diminished or that Petitioner’s interventions lessened those behaviors prior to February 10.

Moreover, contrary to Petitioner’s contention that its interventions were “thorough and compliant” (P. Post-hrg. Reply at 3), Resident 3’s care plan did not establish an effective monitoring schedule until after the resident successfully eloped.  The Code Green sheet documented that the resident needed visual supervision whenever she was near the exits.  CMS Ex. 3.  Similarly, Resident 3’s care plan listed the following intervention, dated January 3, 2019:  “Monitor location every (Specify 15/30/60) min (Freq).  Document wandering behavior and attempted diversional interventions in behavior log.”  CMS Ex. 6 at 10.  However, the care plan entry from January 3 did not specify how often staff

**Page 13**

should monitor Resident 3’s location, making this intervention hard to follow.  *Id.* Perhaps as a consequence, there is little evidence that staff consistently monitored Resident 3’s movements prior to the February 10 incident.  Isolated “Alert Charting Notes” from January 4, 8, 12, and 14, document that Resident 3 was wandering, exit seeking, going out to the courtyard, and also needed to be redirected from the piano area.  CMS Ex. 5 at 3-4.  Only the January 12 note at 11:38 pm indicates that “frequent checks” were done that shift.13  *Id.*at 4.

Following a note from January 17 describing the elopement risk assessment, there are no documented observations concerning Resident 3 until February.  *Id.*; *see also*CMS Ex. 8 at 23.  Between February 3 and February 10, 2019, there are no progress notes documenting Resident 3’s behavior.  CMS Ex. 8 at 23.  It was not until February 11, 2019, the day *after*Resident 3 eloped, that Petitioner revised the care plan, specifying that staff should monitor Resident 3’s location “every 15 minutes.”  CMS Ex. 6 at 9.  Similarly, Petitioner’s staff did not begin documenting the required visual checks until February 11, 2019, the day following Resident 3’s elopement.  *See e.g.,*CMS Ex. 7; CMS Ex. 8 at 23; *see also*Tr. at 71 (surveyor found no documentation of 15, 30, or 60 minute checks of the resident anywhere in Petitioner’s records).  Had Petitioner implemented consistent visual checks of Resident 3 prior to February 10, she may not have succeeded in eloping.

Petitioner relies on the written direct testimony of its administrator and its expert witness to support the premise that it adequately managed Resident 3’s wandering prior to her successful elopement.  P. Post-hrg. Br. at 3-4.  I do not fully credit this testimony because it is inconsistent with Petitioner’s own documentation, as described above.  I accord more weight to the documents, i.e., the Code Green sheet, the elopement assessments, the nursing notes, and the elopement investigation report, than to the written direct testimony of Petitioner’s witnesses.  The assessments, notes, and investigation report were created close in time to the events in question and as part of Petitioner’s usual course of business.  By contrast, the written testimony of Petitioner’s witnesses was prepared later in time and in response to the present litigation.

Petitioner determined, based on its own assessment of Resident 3, that she required monitoring and documentation of her behaviors to keep her safe.  *See*CMS Ex. 3, CMS Ex. 6 at 10.  Petitioner made this determination *before*the resident eloped on February 10.  *Id.*; *see also*Tr. at 58 (surveyor testified that “[t]here should have been some documentation of the Resident’s wandering behavior per [the facility’s] own care plan

**Page 14**

developed on 1/3.”)  That Petitioner failed to implement these interventions supports a deficiency finding.  The quality of care regulations require SNFs to furnish the care and services prescribed in the resident’s care plan.  *Life Care Ctr. of Bardstown*, DAB No. 2479, at 22 (2012) (citing cases), *aff’d, Life Care Ctr. of Bardstown v. Sec’y of Health & Human Servs.*, 535 F. App’x 468 (6th Cir 2013); *see also Good Shepherd Home for the Aged, Inc.*, DAB No. 2858 at 12 (2018) (a resident care policy may reflect the facility’s own judgment about how best to achieve compliance; thus, failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard) (citing *Bivins Memorial Nursing Home*, DAB No. 2771 at 9 (2017)); *Sheridan Health Care Ctr.,* DAB No. 2178 at 32 (2008) (holding that a SNF’s failure to follow its own meal-monitoring policies “constituted a deficiency under section 483.25” and stating that a facility’s adoption of a resident care policy supports an inference that the policy was “necessary to attain or maintain resident well-being”).

Petitioner’s failure to fully implement the interventions prescribed in Resident 3’s care plan likely contributed to the resident’s successful elopement.  On February 10, one of Petitioner’s nurses directed the CNAs to watch Resident 3 near the door to the memory care unit because it was not latching.  CMS Ex. 9 at 5.  Nevertheless, Petitioner’s documentation (or lack thereof) suggests that no one was monitoring Resident 3 for around 45 minutes on the day she eloped.  According to Petitioner’s own timeline of the incident, from around 2:00 pm to around 2:45 pm, no member of Petitioner’s staff was aware of Resident 3’s whereabouts.  CMS Ex. 9 at 1.  Moreover, the fact that one of the Memory Care Unit doors was not latching properly on February 10, 2019 is additional evidence of a deficiency under 42 C.F.R. § 483.25(d).

Petitioner’s investigation report concluded that Resident 3 “may have exited the locked unit . . . via the door by the piano room . . . [which] had been found not to latch properly previously.”  CMS Ex. 9 at 1.  The investigation report further noted that, on the day of the incident, “the resident was able to find the unlatched door and exited.”  *Id.*  The same report includes notes documenting that one of Petitioner’s nurses sent an email requesting maintenance to check on the door because visitors discovered it was not latching properly (it was taking 15-20 seconds to latch).14  *Id*at 5*.* Petitioner’s investigation report persuades me, by a preponderance of the evidence, that Resident 3 exited the Memory Care Unit through the door near the piano room.  Once the resident left the locked unit,

**Page 15**

the Wanderguard system (and staff’s response to the Wanderguard alarm) became the last line of defense to protect the resident from eloping.

Petitioner recognizes that both the Wanderguard system and the locked Memory Care Unit were necessary to prevent Resident 3 from eloping, providing a “double layer of security.”  P. Post-hrg. Br. at 3, 9-10.  Petitioner does not dispute that the alarm to the West Annex building exit sounded at 2:00 pm and that Resident 3 left the building at that time.  *See*CMS Ex. 9 at 1.  However, the parties disagree as to whether Petitioner’s staff responded adequately when the alarm sounded.  Petitioner maintains that staff’s response to the Wanderguard was appropriate.  P. Post-hrg. Br. at 5.  Administrator Perry and Nurse Diaz testified that the nurse on duty “immediately responded to the alarm” and “checked the immediate area outside the door per Maryville policy in place at that time.”  P. Ex. 8 at 5 (¶ 12); P. Ex. 9 at 7 (¶ 14).  According to Petitioner, at the time Resident 3 eloped, the nurse’s actions were “reasonable under the circumstances, as from time to time the door alarm would sound when a non-eloping resident with an alarm device simply got too close to the door – which was initially what appeared to have occurred in this instance.”15  P. Post-hrg. Br. at 5.

Contrary to Petitioner’s arguments and witness testimony, the record does not establish that staff adequately responded to the alarm at the time Resident 3 eloped.  Petitioner’s own elopement policy requires staff to report immediately to the charge nurse if a resident is suspected of being missing.  P. Ex. 5 at 10.  While in this instance Nurse T.B. promptly responded to the door alarm, she did not take all reasonable steps to determine whether a resident had eloped or was missing thereafter.  In particular, the responding nurse disengaged the alarm, apparently in the mistaken belief that it was a false alarm.  As a result, it took roughly 45 minutes for someone to discover that Resident 3 was missing.  This was more than enough time for Resident 3 to elude the efforts of staff to locate her.  Ultimately, Petitioner alerted police, who were able to locate the resident, but only after two hours had elapsed and the resident had suffered a fall in which she fractured her hand and bruised her face.

In an effort to downplay its responsibility for Resident 3’s elopement, Petitioner seems to suggest that the resident herself was to blame for eloping undetected, stating that she was

**Page 16**

a “fast walker,” “had quickly moved outdoors and out of the vicinity of where Resident 3 could be seen, which prevented [Petitioner’s] nurse from spotting Resident 3 immediately,” and Resident 3 “wore a warm coat to effectively blend in with visitors who also wore coats that day.”  *See, e.g.*, P. Post-hrg. Reply at 6.  Regardless of how fast Resident 3 walked, or whether or not she blended in with visitors, the behaviors Resident 3 exhibited on February 10, 2019, were well-known to Petitioner *before*the resident successfully eloped.  The behaviors Petitioner references are consistent with Resident 3’s Code Green sheet, her progress notes, and her elopement risk assessment.16  It was therefore incumbent upon Petitioner to implement interventions that would effectively protect Resident 3 from the risk of elopement, *taking into consideration her known behaviors.*The regulations impose on facilities, such as Petitioner, the responsibility to “provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice.”  *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 6 (internal quotation marks omitted).

The failures by Petitioner’s staff plainly undermined the effectiveness of the very interventions put in place to protect Resident 3 from eloping and directly led to her elopement.  On February 10, 2019, the door to the locked Memory Care Unit was not latching which, according to Petitioner’s investigation report, allowed Resident 3 to exit the unit.  At around 2:00 pm, no member of Petitioner’s staff was aware of Resident 3’s whereabouts, in contravention of her care plan and nurses’ orders.  Staff did not discover that Resident 3 was missing until around 2:45 pm – approximately 45-55 minutes after staff last saw her.  Resident 3 was not found until 4:00 pm – approximately two hours

**Page 17**

after she exited.17  When found miles from the facility and in inclement weather conditions, the resident had sustained injuries from a fall.  In any event, it was entirely foreseeable that Resident 3 would take advantage of the now-accessible exit path and elope.  *See* CMS Ex. 4; CMS Ex. 9 at 1.  Even if Resident 3 never attempted to elope prior to February 10, 2019, Petitioner did not implement even the level of supervision it had determined was appropriate for Resident 3’s needs, based on its assessment of the behaviors and diagnoses of which it was aware.  Further, once outside the facility the resident was at risk of injury, such as frostbite or hypothermia, given the inclement weather conditions.  And, although those particular risks did not materialize, the resident experienced a fall, resulting in fractures and bruising.

Based on the foregoing, I find by a preponderance of the evidence that Petitioner did not comply with the requirements of 42 C.F.R. § 483.25(d).  Resident 3 suffered actual harm and was at risk for more serious harm as a result of Petitioner’s noncompliance.  Accordingly, Petitioner’s noncompliance was substantial and CMS was authorized to impose remedies as a result.  In the following sections of this decision, I explain why I conclude that CMS’s determination of immediate jeopardy is not subject to review and why the CMP imposed is reasonable.

***CMS’s finding of immediate jeopardy is not subject to review.***Petitioner argues that even if it failed to meet the requirements of 42 C.F.R. § 483.25(d), the situation does not rise to the level of immediate jeopardy.  P. Br. at 12.  In Petitioner’s view, SOM guidance forbids an immediate jeopardy citation because the “threat must be present when the surveyors are onsite and must be of such magnitude as to seriously jeopardize a patient’s health and safety.”  P. Post-Hearing Br. at 11 (citing SOM, ch. 3 at 31-3218).  Petitioner mis-identifies the applicable guidance.

**Page 18**

Petitioner’s brief quotes from SOM chapter 3, section 3010A, a subsection of section 3010, which governs “Termination Procedures – Immediate Jeopardy to Patient Health and Safety (Medicare).”  Since CMS did not propose to terminate Petitioner from participating in Medicare, these provisions are inapplicable to the present case.  Instead, the applicable guidance appears in Appendix Q to the SOM, which governs immediate jeopardy more generally.  Appendix Q states unequivocally, “It is not necessary for noncompliance to be present and ongoing at the time of the . . . survey in order for the . . . surveyor to cite [immediate jeopardy].”  SOM, Appendix Q at 13.  Chapter 7 of the SOM further provides that “[p]ast noncompliance may be identified during any survey.”  SOM, ch. 7, § 7510.  That same section “strongly urges States to recommend the imposition of a CMP for past noncompliance cited at the level of immediate jeopardy.”  *Id.* The provisions of Chapter 7 and Appendix Q demonstrate that the surveyor could properly cite a deficiency for past noncompliance at the immediate jeopardy level.19

The point is essentially moot, however, because the regulations do not permit me to review the finding of immediate jeopardy in this case.  An administrative law judge may review CMS’s scope and severity findings (including a finding of immediate jeopardy) only if:  (1) a successful challenge would affect the range of the CMP; or (2) CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s Nurse Aide Training and Competency Evaluation Program (NATCEP).  42 C.F.R. § 498.3(b)(14), (d)(10); *see also Cedar Lake Nursing Home*, DAB No. 2344 at 9 (2010); *Evergreen Commons*, DAB No. 2175 at 2 (2008), *aff’g*DAB CR1684 (2007); *Aase Haugen* *Homes, Inc.*, DAB No. 2013 (2006).

In the case of a per-instance CMP, the regulations provide for a single penalty range ($2,140 to $21,393) without regard to the level of noncompliance.  42 C.F.R. § 488.438(a)(2).  Here, CMS imposed a per-instance CMP of $18,370.  Thus, the finding of immediate jeopardy does not affect the range of the CMP.  *See NMS Healthcare of Hagerstown*, DAB No. 2603 at 6-7 (2014); *see also* *Oaks of Mid City Nursing & Rehab. Ctr.*, DAB No. 2375 at 24 (2011).  Similarly, CMS’s scope and severity finding does not affect approval of the facility’s NATCEP.20  Under the statute and regulations, the state

**Page 19**

agency cannot approve the program if CMS imposes a penalty of $10,69721 or more; the facility loses its approval without regard to the immediate jeopardy finding, even if that finding constitutes substandard quality of care.  Act § 1819(f)(2)(B) (42 U.S.C. § 1395i‐3(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); *see Sunshine Haven Lordsburg*, DAB No. 2456 at 3 (2012), *aff’d in part, Sunshine Haven Nursing Operations, LLC v. U.S. Dep’t of Health & Human Servs.*, 742 F.3d 1239 (10th Cir. 2014).  Under the statute and regulations, it is the dollar amount of the CMP, and not the level of noncompliance, that results in the loss of the facility’s NATCEP.  Because the dollar amount of the CMP is above the threshold that triggers loss of NATCEP approval (and I affirm the amount of the CMP below), the absence of substandard quality of care would not restore Petitioner’s NATCEP.  For these reasons, I have no basis to review CMS’s determination that Petitioner’s deficiencies posed immediate jeopardy to its residents.

***A per-instance CMP of $18,370 for the incident that occurred on February 10, 2019, is reasonable.***My authority to review the reasonableness of a CMP imposed by CMS is limited by 42 C.F.R. § 488.438(e).  The limitations are:  (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review CMS’s exercise of discretion to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  The factors in section 488.438(f) include:  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) the factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  The factors listed in § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

Unless a facility contends that a particular regulatory factor does not support the CMP amount, the administrative law judge must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).  My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not required to defer to CMS’s determination of the reasonable amount of the CMP to impose, but I may only consider the regulatory factors described above.  My role is to determine whether the amount of any CMP imposed is “within reasonable bounds” considering the purpose of the Act and regulations.  *Emerald Oaks*, DAB No. 1800 at 12; *see also CarePlex of Silver Spring*, DAB No. 1683 at 17 (1999).

**Page 20**

In this case, CMS imposed an $18,370 per-instance CMP, which falls near the top of the CMP range in effect at the time CMS imposed the remedy.22  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2018).  However, considering that CMS might instead have imposed a comparable per-day penalty for multiple days of substantial noncompliance, this penalty is modest.  *See Plum City Care Ctr.*, DAB No. 2272 at 18-19 (2009) (agreeing with the administrative law judge’s observation that even the maximum per-instance CMP can be a “modest penalty when compared to what CMS might have imposed.”).

CMS argues that the proposed CMP is reasonable for Petitioner’s violation of 42 C.F.R. § 483.25(d) based on consideration of the relevant regulatory factors at 42 C.F.R. § 488.438(f).  CMS Br. at 9-10.  CMS points out that Petitioner is culpable because the lack of supervising Resident 3 wandering near the exit doors suggests neglect, indifference and disregard for Resident 3’s safety.  CMS Post-hrg. Br. at 14-15.  Petitioner argues that the regulatory factors related to imposition of the CMP do not support the amount imposed, and instead show that the CMP was unreasonably high and should be withdrawn entirely or substantially reduced.  P. Post-hrg. Br. at 12.

For the reasons explained in the earlier sections of this decision, I have rejected Petitioner’s contention that it complied substantially with 42 C.F.R. § 483.25(d).  I reject Petitioner’s contention that the CMP is unreasonable for similar reasons.  First, I conclude that Petitioner’s noncompliance was serious.  Despite being aware of Resident 3’s elopement history, impaired cognition, and tendency to wander around exit doors, Petitioner failed to adequately monitor and supervise Resident 3, which allowed her to elope from the facility undetected.  While Petitioner denies that the elopement caused actual harm, Resident 3 *did* suffer actual harm, sustaining injuries to her head, face, and hands – injuries that required treatment at the emergency room.  Furthermore, the amount of time during which Resident 3 was unaccounted for exposed her to the risk of more serious injury or even death, particularly given the cold weather conditions.  The temperature that day was around 37 degrees with snow showers.  CMS Ex. 13.  Furthermore, the facts demonstrate that Petitioner was culpable (in the sense that it was responsible) for failing to protect Resident 3 from her foreseeable accident.  Finally, Petitioner’s failure to supervise Resident 3 suggests that other vulnerable residents prone to wandering could have been at similar risk of eloping from the facility undetected.

With regard to Petitioner’s prior history of noncompliance, a Life Safety Code survey that concluded on June 5, 2019, found Petitioner out of compliance with Tag K222 at the immediate jeopardy level (scope and severity level “K”).  CMS Ex. 2 at 6.  Petitioner offered no evidence that its financial condition affects its ability to pay the CMP.  Unless

**Page 21**

a facility contends that a particular regulatory factor does not support the CMP amount, an administrative law judge must sustain it.  *Coquina Ctr.*, DAB No. 1860.

Based on the seriousness of Petitioner’s noncompliance, Petitioner’s past history of noncompliance, and culpability, I conclude that the $18,370 per-instance CMP is reasonable.

V. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d).  I further conclude that the per-instance CMP of $18,370 is reasonable.

1  CMS and state survey agencies consider the scope and severity of deficiencies when selecting enforcement remedies.  CMS summarizes the scope and severity levels in a matrix published in the State Operations Manual (SOM).  SOM, CMS Pub. 100-07, ch. 7, § 7400.3.1 (Rev. 185, effective November 16, 2018) available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07pdf.pdf (last visited Dec. 13, 2022).  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each scope and severity level.  “Scope” describes how many residents are potentially affected by a particular deficiency.  Deficiencies may be “isolated,” “pattern,” or “widespread” in scope.  “Severity” describes the possible harm that a deficiency may cause.  A scope and severity level of A, B, or C describes a deficiency that causes no actual harm with the potential for minimal harm.  Facilities cited with deficiencies at level C or lower remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F describes a deficiency that has caused no actual harm but has the potential to cause more than minimal harm that is not immediate jeopardy.  A scope and severity level of G, H, or I describes a deficiency that has caused actual harm that is not immediate jeopardy.  Scope and severity levels J, K, and L describe deficiencies that pose immediate jeopardy to resident health or safety.

2  CMS increases the CMP amounts annually to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  *See*81 Fed. Reg. 61,538 (Sept. 6, 2016).

3  My conclusions of law appear as headings and subheadings in bold italic type.  My findings of fact appear in the supporting text.

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

5  To protect her privacy, I refer to the resident by the numerical identifier assigned during the survey.  *See*CMS Ex. 1.

6  The Memory Care Unit is a locked unit within Petitioner’s facility.  *See*P. Ex. 8 at 5 (¶ 13).  The floorplan for the facility identifies the Memory Care Unit by the initials “HKC.”  *See*CMS Ex. 4 at 1.

7  Resident 3’s care plan describes the device as a “Wander Alert.”  CMS Ex. 6 at 11.

8  Before exiting the facility, Resident 3 left the Memory Care Unit without setting off any door alarms.

9  Petitioner’s investigation report states that maintenance staff came to the West Annex to check on the door at an unspecified time but did not discover any issues with the lock.  CMS Ex. 9 at 1.

10  Based on Petitioner’s floor plan, the Memory Care Unit and Piano room are located in the West Annex of the property.  *See* CMS Ex. 4 at 1.

11  Petitioner’s Administrator and its Nurse Consultant both provided written testimony in which they opine that Petitioner’s care of Resident 3 was not deficient.  P. Ex. 8 at 2 (¶¶ 4, 5); P. Ex. 9 at 5 (¶ 8).  I accord little weight to those portions of the witnesses’ testimony, because whether Petitioner substantially complied with the regulations is a question of law reserved for my decision.

12  The investigation report does not document the date on which Resident 3 made this statement.  Further, even accepting that the resident made such a statement, given her diagnoses of Alzheimer’s disease and dementia with behavioral disturbances, it is unlikely her desire to remain at the facility (or to leave) would remain consistent from day to day, or even hour to hour.

13  At the hearing, counsel for Petitioner made a point of inquiring about the general practice of nursing facilities documenting “by exception.”  Tr. at 52.  The surveyor agreed that the term means noting something that deviates from the baseline.  *Id.* Using this definition, I infer that prior to February 10, documenting frequent visual checks of Resident 3 were the exception rather than the rule.

14  As Petitioner’s investigation report makes clear, it was Petitioner’s own staff who concluded that there was a problem with the door latching.  CMS Ex. 9 at 4, 5.  Thus, the assertion that the state agency surveyor “falsely” concluded that the locks to the Memory Care Unit door were defective rings hollow.  *See*P. Post-hrg. Reply at 9.  Further, even if the door latched properly when maintenance staff checked it, this does not disprove that the door failed to latch earlier that day.

15  This assertion weakens Petitioner’s argument that the facility’s use of the Wanderguard was effective at the time Resident 3 eloped.  As CMS correctly states, if the system was generating false-positive alerts, Petitioner should have conducted a system review, including reconsideration of the alarm locations and staff response protocols.  CMS Post-hrg. Br. at 10.  Tolerating false positive alerts is also inconsistent with the facility’s elopement policy, which requires maintenance staff to regularly inspect and maintain locking mechanisms and door alarms of the Wanderguard system, including doors to the Memory Care Unit, and report any defects.  P. Ex. 5 at 7.

16  CMS argues that Petitioner could have taken the additional precaution of placing the Code Green sheet at other exits in addition to the front desk.  CMS Post-hrg. Br. at 7.  At the hearing, the state agency surveyor testified that it would have been “prudent” for the facility to place the Code Green sheet near the exit in the West Annex, the area from which Resident 3 eloped.  Tr. at 44-45.  That particular exit door is not visible from the front desk, so it was easier for Resident 3 to exit the facility undetected.  *See* CMS Ex. 4; *see also*CMS Ex. 9 at 6 (the doors adjacent to the Memory Care Unit “are low visibility doors.”).  The evidence before me is unclear as to whether there is a nursing station near the door through which the resident eloped.  The notation that the door is “low visibility” may mean that staff are not routinely near enough to monitor the exit reliably.  *See*CMS Ex. 5 at 9 (Nurse TB told surveyor she did not see anyone near the door “by the time she got down to the exit.”).  Perhaps this is why Petitioner decided to stop allowing staff and visitors to enter and exit through this door.  *See*P. Ex. 8 at 6 (¶ 14); P. Ex. 9 at 8 (¶ 15) (door is now solely a fire exit).  Because I cannot find by a preponderance of the evidence that placing the Code Green sheet near the West Annex door would have aided in preventing Resident 3 from eloping, I do not rely on the distribution of the Code Green sheet in concluding that the facility failed to comply with 42 C.F.R. § 483.25(d).

17  Petitioner challenges CMS’s assertion that Resident 3 was missing “for nearly three hours.”  P. Post-hrg. Reply at 11.  I infer, based on the record, that Petitioner was unable to locate Resident 3 for approximately two hours (from between 1:50 and 2:00 pm until approximately 4:00 pm).  However, the difference between three hours and two hours is not material to my analysis.  Decisions of the DAB have upheld findings of immediate jeopardy in cases where the resident eloped undetected and was unsupervised for as few as 10 to 15 minutes*.  See Golden Age Skilled Nursing & Rehab. Ctr.*, DAB No. 2026 (2006).

18  Page citations are to the PDF page numbers as displayed on the CMS website.  Chapter 3 of the SOM is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c03pdf.pdf (last visited December 14, 2022).

19  In light of the Supreme Court’s decision in *Azar v. Allina Health Services*, 139 S. Ct. 1804 (2019), it is unclear what weight, if any, to give sub-regulatory guidance such as CMS manuals when adjudicating an administrative appeal.  Certainly, such guidance does not have the force and effect of regulations, which, on their face, authorize CMS to impose CMPs for past noncompliance.  42 C.F.R. § 488.430(b); *see also Donelson Place Care and Rehab. Ctr.*, DAB No. 3046 at 23 (2021) (“past noncompliance” is a term of art meaning “a period of noncompliance which not only began but also was corrected by the facility itself before the survey.”).

20  The record does not reveal whether Petitioner maintained a NATCEP during the period in question.

21  The CMP dollar amount that triggers disapproval of a NATCEP was adjusted upward for 2018.  83 Fed. Reg. at 51,388.

22  As previously explained, with inflation adjustment, the CMP range at the time of the June 2019 survey was $2,140 to $21,393.  83 Fed. Reg. at 51,380.
  
          /s/
        Leslie A. Weyn

                      Administrative Law Judge Back to top
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