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# Azria Health Olathe, DAB CR6018 (2022)

----

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

## Azria Health Olathe(CCN: 175557),Petitioner,

## v.

## Centers for Medicare & Medicaid Services.

### Docket No. C-20-105Decision No. CR6018January 24, 2022

### DECISION

Petitioner, Azria Health Olathe (Azria or Petitioner), is a long-term care facility, located in Olathe, Kansas, that participates in the Medicare program.  Following a survey by the Kansas Department for Aging and Disability Services (KDADS) that was completed on July 23, 2019, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and imposed a per-instance civil money penalty (CMP) of $15,310.  CMS Exhibits (Exs.) 13 and 18.  Petitioner has appealed, and the parties filed cross-motions for summary judgment.

For the reasons set forth below, I grant CMS’s motion; Petitioner has not come forward with evidence that, if believed, would show that it did everything possible (within the meaning of the regulation) to minimize the risks of accidents.  Indeed, the undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements and that the penalty imposed is reasonable.

**Page 2**

### I.     BACKGROUND

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys.  Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

In this case, following a complaint, a surveyor from the KDADS went to the facility and completed an investigation on July 23, 2019.  CMS Ex. 13.  Based on those findings, CMS determined that “the conditions in the facility constituted past noncompliance immediate jeopardy to resident health and safety.”  *Id.*  A per-instance CMP in the amount of $15,310 was imposed for the incident on July 18, 2019, “described at the Federal citation, F0689-S/S: K - 483.25(d)(1)(2) [Facility was not in substantial compliance with one Medicare participation requirement:] Free of Accident Hazards/Supervision/Devices.”  *Id.*

On November 15, 2019, Petitioner filed a timely request for hearing.  On November 25, 2019, Judge Bill Thomas issued an Acknowledgment and Prehearing Order setting forth prehearing procedures.1  CMS filed a motion for summary judgment and brief in support (CMS Br.), along with 18 exhibits (CMS Exs. 1-18).  Petitioner filed its brief and cross-motion for summary judgment (P. Br.), with four exhibits (P. Exs. 1-4).  CMS filed a Reply Brief (CMS R. Br.).  There being no objections, CMS Exs. 1-18 and P. Exs. 1-4 are admitted into the record.

### II.    ISSUES

As a threshold matter, I consider whether summary judgment is appropriate.  On the merits, the issues are:

**Page 3**
                            - Was the facility in substantial compliance with 42 C.F.R. § 483.25(d)(1) and (2); and
                            - If the facility was not in substantial compliance, is the penalty imposed – $15,310 per-instance – reasonable?

I have no authority to review CMS’s immediate jeopardy determination in this case.  I may review CMS’s scope and severity findings (which include 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 program.  42 C.F.R. § 498.3(b)(14), (d)(10); *NMS Healthcare of Hagerstown*, DAB No. 2603 at 6-7 (2014); *Cedar Lake Nursing Home*, DAB No. 2344 at 9 (2010); *Heritage Park Rehab. & Nursing Ctr*., DAB No. 2231 at 15-16 (2009); *Evergreen Commons*, DAB No. 2175 (2008); *Aase Haugen Homes*, *Inc*., DAB No. 2013 (2006).

For a per-instance penalty, the regulations provide only one range ($ 2,140 to $21,393), so the level of noncompliance here does not affect the range of the CMP.2  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3; 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).  While there is no evidence of a nurse aide training program here, if I approve a penalty of $ 10,697 or more, which I do, CMS’s scope and severity finding will not affect approval of the facility’s nurse aide training program.  Under the statute and regulations, the state agency cannot approve the program if CMS imposes a penalty of $10,697 or more.  The facility would therefore lose its approval without regard to the immediate jeopardy finding.  Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 82 Fed. Reg. at 9188.  As a result, the immediate jeopardy determination is not subject to review in this adjudication.

### III.   DISCUSSION

**Summary judgment**.  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  *Bartley Healthcare Nursing & Rehab.*, DAB No. 2539 at 3 (2013) (citing*Celotex Corp. v. Catrett*, 477 U.S. 317, 322-25 (1986)); *Ill. Knights Templar Home*, DAB No. 2274 at 3-4 (2009) (and cases cited therein).

**Page 4**

The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non- moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  *Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs.*, 388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex*, 477 U.S. at 322).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  *Matsushita Elec. Indus. Co. v. Zenith Radio Corp.*, 475 U.S. 574, 586 n.11 (1986); *see also Vandalia Park*, DAB No. 1939 (2004); *Lebanon Nursing & Rehab. Ctr.*, DAB No. 1918 (2004).  The non-moving party may not simply rely on denials but must furnish admissible evidence of a dispute concerning a material fact.  *Ill. Knights Templar*, DAB No. 2274 at 4; *Livingston Care Ctr*., DAB No. 1871 at 5 (2003).  In doing so, the non-moving party must show more than “some metaphysical doubt as to the material facts.”  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6 (2015), *aff’d**sub nom. W. Tex. LTC Partners, Inc. v. U.S. Dep’t of Health & Human Servs.*, 843 F.3d 1043 (5th Cir. 2016); *1866ICPayday.com, L.L.C.*, DAB No. 2289 at 3 (2009) (quoting *Matsushita*, 475 U.S. at 587).

In examining the evidence for purposes of determining whether summary judgment is appropriate, I must draw all reasonable inferences in the light most favorable to the non- moving party.  *Brightview Care Ctr.*, DAB No. 2132 at 2, 9 (2007); *Livingston Care Ctr.*, 388 F.3d at 172; *Guardian Health Care Ctr.*, DAB No. 1943 at 8 (2004); *see also**Brightview*, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non- moving party’s legal conclusions.  *W. Tex. LTC Partners,*, DAB No. 2652 at 6-7; *cf. Guardian*, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”).

**Summary judgment applied to administrative review in Medicare cases**.  It is well-established that an administrative law judge is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  *Shah v. Azar*, 920 F.3d 987, 996 (5th Cir. 2019) (citing *Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 619 F.3d 453, 457 (5th Cir. 2010)); *see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs.*, 604 F.3d 445, 449 (7th Cir. 2010).  Nevertheless, there seems to be some confusion about applying such well-founded principles of civil litigation to these proceedings, with some suggesting that, to do so, denies a party a fundamental right.  In one succinct observation, Judge Posner of the Seventh Circuit Court of Appeals gave lie to such misapprehensions:  “All it means for a decision to be based on a grant of

**Page 5**

summary judgment is that there are *no issues that would benefit from being resolved in an evidentiary hearing*.”  *Fal-Meridian*, 604 F.3d at 449 (emphasis added).

In *Fal-Meridian*, the Seventh Circuit considered specifically the appropriateness of granting CMS summary judgment in a nursing home case involving (then) section 483.25(h) (now section 483.25(d)).3  The court sustained the administrative law judge’s granting summary judgment in CMS’s favor because the petitioner/nursing home did not tender “evidence that, if believed, would show that it had done everything possible (within the meaning of the regulation) to minimize the risks of an accident.”  *Fal- Meridian*, 604 F.3d at 451.  The court stated that the relevant questions were:  1) whether the facility’s “handling of [the resident’s] physical and mental infirmities was consistent with its duty to keep the [facility] as free as possible from hazards that might cause an accident,” and 2) if not consistent, whether the facility’s dereliction of its duty “was likely to cause . . . serious injury, harm, impairment, or death to a resident.”  *Fal- Meridian*, 604 F.3d at 447.

***1. CMS is entitled to summary judgment because the undisputed evidence demonstrates the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2).4  Petitioner’s motion for summary judgment is denied.***

Section 1819(b)(2) of the Act requires that a facility must ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2).  To this end, the “quality of care” regulation mandates, among other requirements, that the facility “ensure” that each resident’s environment remains as free of accident hazards as possible and that each resident receives adequate supervision and assistance devices to prevent accidents.  42 C.F.R. § 483.25(d)(1)(2)***. ***The question in this case is whether Petitioner provided adequate supervision and assistance devices to prevent the elopement that occurred on July 18, 2019.

These facts are not in dispute.  Resident #1 (R1), who was 86 years old, was admitted to Azria on July 2, 2019, with diagnoses including past myocardial infarction, cardiomyopathy, congestive heart failure, hypertension, and hypothyroidism.  CMS Ex. 3

**Page 6**

at 2.  According to the Minimum Data Set (MDS) assessment, R1’s cognition was severely impaired; he scored 6 out of 15 on the Brief Interview for Mental Status (BIMS), a tool that assesses cognitive function, when assessed on July 9, 2019.5  CMS Ex. 5 at 10, 57.  His functional abilities were impaired; his walking was not steady but he was able to stabilize without human assistance.  CMS Ex. 5 at 20.  In an assessment of wandering, behavior of that type was reported to have occurred on 1-3 days, and it placed him at significant risk of getting to a potentially dangerous place.  CMS Ex. 5 at 15-16.  Azria’s assessed elopement risk for R1 on July 2, 2019, was 6.0, noted to be a high risk of elopement.  CMS Ex. 6 at 1.  A General Progress Note dated July 3, 2019, indicated R1 seemed confused, wandering around with an unsteady gait, seeking an exit.  *Id.*  He was verbalizing to “call cops to let him out of here.”  *Id.*  He was placed in Azria’s secure memory care unit, which, according to Petitioner, had secured entry and exits that were regularly checked for proper functioning.  P. Br. at 5.

There is also no dispute that on July 18, 2019, R1 eloped from the facility and was found outside on facility grounds.  To be sure, there are some conflicts in the record as to the exact timing of R1’s elopement and the length of time he was out of the facility.6  When he was last seen prior to the elopement is not definitively established.  Stephanie Perkins, a CNA, provided two statements in which she indicated that she had seen R1 around the time they were setting up dinner trays, at approximately 5:00 pm.  She stated that when she got to the tray with his name on it, she realized he wasn’t in the dining room; she alerted others, and they began to look for him.  He was discovered outside the facility, and she helped return him to the facility at about 5:30 pm.  CMS Ex. 10; CMS Ex. 16 at 32.  A statement taken by the Administrator similarly indicated that Ms. Perkins last saw R1 at 5:00 pm or later as they were preparing for dinner service.  CMS Ex. 16 at 35.  A statement from another CNA on the unit, Hareg Endale, indicated R1 was last seen around dinnertime, but she did not know the exact time.  *Id.*  A resident of the facility provided a statement in which he reported that he saw R1 outside the facility at approximately 3:40 pm.  *Id.*  Another CNA/CMA stated he discovered an open window and they searched for the resident for 10 to 20 minutes.  CMS Ex. 16 at 28.  Based on these statements, R1 could have been outside the facility anywhere from 10 minutes to nearly two hours.

**Page 7**

For the purposes of summary judgment, however, I have utilized Petitioner’s characterization of the events of July 18, 2019:

At or around 5:30 pm on [July 18], staff and residents at Azria were beginning the dinner service and gathered residents to go to the dining room.  When it was [R1’s] turn to go to dinner, staff could not find him, despite having seen him very recently wandering through the hallways as they were taking other residents to dinner.  Staff immediately initiated the facility protocol for missing residents.  R1 was found outside in a grassy area at the rear of the facility, on facility property, within minutes.  [He] was not found near any roads[.]  

P. Br. at 5 (citations omitted).  R1 had no injuries other than some bruising, an injury to a finger on his left hand, and an abrasion on his chest and left knee.  Despite warm temperatures outside, he was not flushed, sweaty, or otherwise exhibiting symptoms of overheating.  *Id.*

Upon investigation by the facility, staff noted an unoccupied room with its window forced off its hinges, which resulted in breaking the window frame and bypassing the safety screws that were in place to prevent the window from opening more than a few inches.  The window was repaired, and additional protection was added to all windows.  *Id.* at 5-6.  According to the Declaration of the Director of Nursing (DON), an inspection of the window in question showed that there were safety screws in place that prevented the window from being opened vertically more than 11⁄2 to 2 inches, and “R1 was only able to exit through the window by physically breaking the window off of its frame.”  P. Ex. 3 at 4.  He stated that the window was hanging askew, and it had been pulled off of its hinges/track.  *Id.*  While it is somewhat questionable whether an 86-year-old individual, 5 feet 5 inches tall and weighing 122 pounds, who required staff assistance with transfers and was a fall risk because of unsteady gait (CMS Ex. 5 at 41, CMS Ex. 7 at 7-8), would be physically capable of performing such a feat, for the purposes of summary judgment, I accept Petitioner’s version of how the elopement occurred.

The issue for resolution here is whether Petitioner provided adequate supervision and assistance devices to prevent the elopement on July 18, 2019.  As noted above, the quality of care regulations, specifically 42 C.F.R. § 483.25(d)(1)(2), require the facility to “ensure” that each resident’s environment remain as free of accident hazards as is possible and that each resident receive adequate supervision and assistance devices to prevent accidents.  The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.”  *Del Rosa Villa*, DAB No. 2458 at 7 (2012); *Clermont Nursing & Convalescent Ctr.*, DAB No. 1923 at 9-10 (2004), *aff’d sub nom. Clermont Nursing & Convalescent Ctr. v. Leavitt*, 142 F. App’x 900 (6th Cir.

**Page 8**

2005); *accord**Briarwood**Nursing Ctr.*, DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”).  A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances.  42 C.F.R. § 483.25(d); *Briarwood*, DAB No. 2115 at 5; *Windsor Health Care Ctr.*, DAB No. 1902 at 5 (2003), *aff’d sub nom. Windsor Health Care Ctr. v. Leavitt*, 127 F. App’x 843 (6th Cir. 2005).

Petitioner makes several arguments as to why it was in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2).  It initially asserts that R1’s elopement was not foreseeable because “[a]s a matter of law, this Tribunal has found that an elopement is *not* foreseeable (and an IJ is clearly erroneous) when a resident elopes from a window by physically breaking the safety system in place to prevent elopement.”7  P. Br. at 7 (citing *Estes Nursing Facility Civic Ctr.,*DAB CR1370 (2005)) (emphasis in original).  In considering this argument, I find that it is first necessary to note that Administrative Law Judge decisions do not carry precedential weight and are not binding on the Board or other ALJs.  *Lopatcong Ctr.*, DAB No. 2443 at 12 (2012); *Universal Health Care – King*, DAB No. 2383 at 9 (2011);*Green Oaks Health & Rehab. Ctr.*, DAB No. 2567 at 9 (2014) (and cases cited therein).  Thus, the holding in *Estes*is not a “matter of law” since the cited decision was issued by an Administrative Law Judge.  Second, the present case is distinguishable from *Estes*regarding section 483.25(d) based on its facts.  Unlike the present case, the resident in *Estes* did not express any desire to leave the facility, had nothing in her record to denote elopement attempts or wandering behavior, and she was not in a locked ward.  Yet, the staff recognized the risk of elopement and noted that risk in the care plan.  It also inspected windows daily and performed an additional window check.  *Estes*,DAB CR1370 (citing *Estes Nursing Facility Civic Ctr.*, DAB CR1240 (2004)).  On the basis of those facts, the ALJ found that the facility fulfilled its obligation to protect its residents from hazards.8  That is not the case here.

**Page 9**

Moreover, Petitioner’s emphasis on whether an act is “foreseeable” is misplaced.  It is correct that the regulation does not impose strict liability on facilities.  However, it does require an “adequate” level of supervision under all the circumstances.  42 C.F.R. § 483.25(d); *Briarwood*, DAB No. 2115 at 5; *Windsor Health Care Ctr.*, DAB No. 1902 at 5, *aff’d sub nom. Windsor Health Care Ctr. v. Leavitt*, 127 F. App’x 843 (6th Cir. 2005).  As the Board stated:

The correct question, however, is not whether a facility avoided all “potential” risk nor whether it failed to mitigate risk below some “unavoidable” level.  The correct question is whether the facility did what it reasonably could to ensure that all residents received supervision needed to “mitigate foreseeable risks of harm” based on what it knew about the residents, their care needs, and the conditions in the facility.  *See Owensboro Place & Rehab. Ctr*., DAB No. 2397 at 8 (2011); 42 C.F.R § 483.25(h).  While specific resident needs, foreseeable risks, and reasonable preventive measures may vary in the multitude of situations presented in different long-term care facilities and are judged by the corresponding standards of care, the underlying regulatory responsibilities are defined no differently for secure or special units.

*The Bridge at Rockwood*, DAB No. 2954 at 10-11 (2019).

Thus, the question I must resolve is whether Azria provided adequate supervision to “mitigate foreseeable risks of harm” to R1.  As noted above, Petitioner did identify R1 as being at significant risk of getting to a potentially dangerous place because of wandering behavior.  CMS Ex. 5 at 15-16.  He had also displayed wandering behavior at the facility and had expressed the desire to get out of the facility.  CMS Ex. 6 at 1.  Petitioner was also aware that R1 had attempted to elope from a previous facility.  CMS Ex. 6 at 3.

Petitioner did have a policy for the “Wandering, Unsafe Resident,” which required the following:  

1.     The staff will identify residents who are at risk for harm because of unsafe wandering (including elopement).2.     The staff will assess at-risk individuals for potentially correctible risk factors related to unsafe wandering.3.     The resident’s care plan will indicate the resident is at risk for elopement or other safety issues4.     Interventions to try to maintain safety will be included in the resident’s care plan.

**Page 10**

5.     Nursing staff will document circumstances related to unsafe actions, including wandering, by a resident.6.     Staff will institute a detailed monitoring plan, as indicated for residents who are assessed to have a high risk of elopement or other unsafe behavior.7.     Staff will notify the Administrator and Director of Nursing immediately, and will institute appropriate measures (including searching) for any resident who is discovered to be missing from the unit or facility.

CMS Ex. 11 at 4.

Considering the evidence in the light most favorable to Petitioner, I find it is readily apparent that many of these provisions were not instituted prior to the elopement on July 18, 2019.  Clearly, as indicated above, Petitioner identified R1 as a resident at risk for harm because of unsafe wandering.  However, there is no evidence of any further implementation of the facility policy on wandering until *after* the elopement.  The risk of wandering and elopement and related interventions were not included in the care plan until July 19, 2019, and later.  CMS Ex. 7 at 1, 4, 7, and 8.  There is also no evidence of any “detailed monitoring plan” as required by facility policy.  CMS Ex. 11 at 4.  When elopement risk was finally added to the care plan after July 18, 2019, the care plan merely indicated that R1 “will be provided supervision and monitoring in a secured environment that allows for diagnostic related safe wandering.”  CMS Ex. 7 at 1.  However, the type and frequency of supervision and monitoring is not specified in the care plan or any other document in the record.  Thus, the record, viewed in the light most favorable to Petitioner, does not establish that it complied with its own policy regarding the level of care and supervision to be provided to R1 prior to his elopement.

In *Heritage Plaza Nursing Center,*DABNo. 2829 (2017*),* the Board stated that 42 C.F.R. § 483.25(d)

“does not prescribe any specific accident-prevention method.*”  Lifehouse of Riverside Healthcare Ctr.,*DAB No. 2774, at 15 (2017).  Rather, “facilities have flexibility to choose the specific methods as appropriate to their circumstances and to employ reasonably necessary measures to comply with the regulation.”  *Id.*(citations omitted).  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, however, the facility is held to follow through on them.  *Id. *Moreover, the Board has stated, “The fact that the regulations do not specify that a particular type of care is necessary to

**Page 11**

meet a requirement does not prevent a finding of noncompliance when the facility itself has determined that type of care is necessary.”  *Id.*, citing *Azalea Court*, DAB No. 2352 at 9.

*Heritage Plaza*, DAB No. 2829at 20.  Petitioner’s failure to provide the care specified in its internal policies is not consistent with providing adequate supervision to prevent accidents.

Petitioner does not directly address the supervision provided to R1 and instead focuses on the safety screws that were installed in the facility’s windows.  It asserts that Board decisions “have held that restricting the full opening of windows mitigates the potential elopement from a window.”  P. Br. at 10 (citing *Briarwood Nursing Ctr.,*DAB CR1551 at 6 (2007)).  While I would concur that installing safety screws could mitigate the potential elopement from a window, I cannot find that this alone constitutes adequate supervision to prevent accidents.  In fact, a full reading of *Briarwood*, a decision by an Administrative Law Judge, includes the holding that the facility’s inability to follow the facility policy on wandering showed that the facility failed to ensure that each resident received adequate supervision.  *Briarwood*, DAB CR1551at 9.  For purposes of summary judgment, I accept Petitioner’s description of the placement of the safety screws “to prevent the window’s vertical rise” and its assertion that R1 eloped by “physically breaking the window frame,” rather than somehow merely opening the window.  P. Br. at 10-11.  The problem in this case was that there was no specified supervision of R1, and the only apparent accident prevention protocols were the safety screws and placement on a secured unit.  The lack of specified supervision allowed R1 to enter an unsecured storage room on the secured unit and take whatever time was necessary, while unobserved and unmonitored, to apparently break the window frame in order to elope.9  But for the fact that it was dinnertime and his labeled tray called attention to the fact he was not in the dining room, the lack of monitoring and supervision could have resulted in R1 being out of the facility for a much longer period of time.  Given the photograph showing the 4-lane highway in front of the facility, the “risk for harm” to a confused elderly resident is readily apparent.  P. Ex. 4; CMS Ex. 11 at 4.

Petitioner does not directly address the apparent failure to follow facility policy on “wandering, unsafe” residents.  Instead, it asserts that because it was not cited for any

**Page 12**

alleged deficiency related to care planning, “it is improper to shoehorn those allegations onto tag F689 now.”  P. Br. at 14.  This position ignores the many Board decisions holding to the contrary.  In *Kenton Healthcare, LLC,*DAB No. 2186 (2008), the Board stated,

Kenton’s failure to include in those plans important information about a resident’s risk of wandering or elopement would clearly hinder the staff’s ability to provide the needed care and supervision required by the regulation.  The Board has confirmed that the measures that a facility adopts to care for its residents are evidence of the facility’s evaluation of what must be done to attain or maintain a resident’s highest practicable physical, mental, and psychosocial well-being, as required by section 483.25.  *Woodland Village Nursing Center*, DAB No. 2053, at 8-9, (2006), *aff’d, Woodland Village Nursing Ctr. v. U.S. Dep’t of Health & Human Servs.*, 239 Fed. Appx. 80 (5th Cir. 2007), citing *Spring Meadows Health Care Center* at 16-18 (addressing facility failures to observe their own policies for resident care).  Failure to fully employ those measures as intended may thus be, as it is here, evidence that the facility failed to provide residents with needed care and supervision as required by the regulation. 

*Kenton*at 22.

Similarly, the Board in *Pinecrest Nursing & Rehabilitation Center*held that failure to have adequate plans of supervision for residents prone to wandering was a sufficient reason to find the facility noncompliant with its obligation under § 483.25(h)(2) to adequately supervise its elopement-prone residents.  DAB No. 2446 at 12-13 (2012) (citing *St. Catherine’s Care Ctr. of Findlay, Inc.,*DAB No. 1964 at 13 n.9 (2005) (holding that a finding of noncompliance with section 483.25(h) is warranted if a facility identifies a risk of harm but fails to plan for it)).As a result, this argument by Petitioner is not persuasive.

The issue here is not whether Azria took *some* steps to mitigate elopement but whether the steps it took were “adequate”; that is, sufficient to meet R1’s assessed needs and reduce risks of accidental harm to the “highest practicable degree.”  *Century Care of Crystal Coast*, DAB No. 2076 at 7 (2007); *Northeastern Ohio Alzheimer’s Research Ctr.,*DAB No. 1935 at 9 (2004).  Azria’s supervision of R1 was plainly inadequate, given its awareness of his high risk of elopement and its failure to adopt a plan to prevent this risk.  As a result, I find that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2).

**Page 13**

***2. The undisputed evidence establishes that the penalty imposed is reasonable. ***

Petitioner initially argues that the CMP was imposed according to the level of the deficiency alleged, i.e.,  a “K” level (“a pattern of IJ to resident health or safety”), but the degree of potential harm is a question of fact to be considered in reviewing the reasonableness of the CMP.  P. Br. at 16 (citing *Innsbruck Healthcare Ctr.,*DAB No. 1948 (2004)).  It then argues that there was no potential harm to other residents and, as a result, the severity level “K” is “patently unreasonable and erroneous.”  P. Br. at 17. 

As discussed extensively above, an ALJ may review CMS’s scope and severity findings, which include a finding of immediate jeopardy, only if a successful challenge would affect the range of the CMP assessed or if CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide training program.  42 C.F.R. § 498.3(b)(14), (d)(10); *Evergreen*, DAB No. 2175 at 2; *Aase Haugen*, DAB No. 2013.  In fact, *Innsbruck*, the case cited by Petitioner as support for its position, involved the loss of approval of a nurse aide training program.  That is not the case here.  As a result, the severity level of the deficiency will not be addressed as part of the reasonableness analysis. 

Petitioner then argues that CMS has not properly assessed the statutorily required factors in determining the CMP.  P. Br. at 15.  It cites the lack of a repeated deficiency and an improper assessment of culpability as support for this argument, specifically noting there had been no showing of neglect, indifference, or disregard for resident care, comfort, or safety on the part of Azria.  P. Br. at 16-17. 

In deciding whether the CMP amount is reasonable, I may consider only the factors specified in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3); *Southpark Meadows Nursing & Rehab. Ctr.*, DAB No. 2703 at 12 (2016).  Those factors are:  “(1) The facility’s history of noncompliance. (2) The facility’s financial condition. (3) The factors specified in 42 C.F.R. § 488.404. (4) The facility’s degree of culpability. . . . [Culpability] includes . . . neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating circumstance.”  42 C.F.R. § 488.438(f).  The factors in 42 C.F.R. § 488.404, in turn, include:  (1) the scope and severity of the deficiency; (2) “[t]he relationship of the one deficiency to other deficiencies resulting in noncompliance”; and (3) “[t]he facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.”  In addition, the Board has held 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.”  *Coquina Ctr.*, DAB No. 1860 at 32 (2002); *Brenham Nursing & Rehab. Ctr.*, DAB No. 2619 at 18 (2015), *aff’d, Brenham Nursing & Rehab. Ctr. v. U.S. Dept. of Health & Human Servs.*, 637 F. App’x 820 (5th Cir. 2016).  “Accordingly, the burden is not on CMS to present evidence bearing on each regulatory factor, but on the SNF [skilled

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nursing facility] to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  *Oaks of Mid City Nursing & Rehab. Ctr.*, DAB No. 2375 at 26 (2011).

Petitioner states that this was not an instance of a repeated deficiency, there was no potential harm to other residents, there was no degree of culpability on its part because it had installed safeguards to prevent residents from eloping, and R1’s elopement was unforeseeable.  P. Br. at 16-17.  However, in considering the regulatory factors listed above, I do not find that Petitioner has met its burden of introducing evidence to demonstrate that a reduction in the penalty amount is necessary to make the CMP reasonable.  *Crawford Healthcare & Rehab.,*DAB No. 2738 at 19 (2016).

CMS has imposed a per-instance penalty of $15,310, which is in the mid- to upper-range for per-instance penalties ($ 2,140 to $21,393).  42 C.F.R. §§ 488.408(d)(1)(iv), 488.438(a)(2); 45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).  Petitioner does not claim that its financial condition affects its ability to pay this fairly modest amount.  Petitioner asserts that this was not an instance of a repeated deficiency, but it has not tendered any evidence relating to its history of compliance prior to the survey cycle presently at issue.

Petitioner’s culpability in this matter is quite high.  Knowing that R1 was at risk for wandering, the facility failed to follow its own internal policy and implemented no specific procedures for monitoring his whereabouts.  This failure resulted in a confused and vulnerable resident being able to enter an unsecured room, remove a window, and leave the facility undetected, exposing him to a significant risk of harm.  For this, the facility is culpable, and the penalty imposed is modest, considering the seriousness of the deficiency.  For these reasons, I find the imposed CMP of $15,310 to be reasonable.

### IV.    CONCLUSION

For all of these reasons, I grant CMS’s motion for summary judgment and deny Petitioner’s motion for summary judgment.  Even accepting Petitioner’s statements of fact, the undisputed evidence establishes that the facility did not ensure that R1 received adequate supervision and assistance devices to prevent accidents.  The facility was, therefore, not in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2).  The penalty imposed – $15,310 per-instance – is reasonable.

Mary M. KunzAdministrative Law Judge

                                              1. This case was assigned to me on December 3, 2021. 
                            - back to note 1
                                                  2. The cases cited by Petitioner for the argument that the finding of immediate jeopardy may be overturned when it is clearly erroneous either involve per-day penalties (Heritage Healthcare & Rehab. Ctr., DAB CR2116 (2010); Woodstock Care Ctr., DAB No. 1726 (2000), aff’d, Woodstock Care Ctr v. Thompson, 363 F.3d 583 (6th Cir. 2003)), or did not involve a CMP (Innsbruck Healthcare Ctr., DAB No. 1948 (2004)).  P. Br. at 3-4.  While Daughters of Miriam Center, DAB No. 2067 (2007), was a case involving a per-instance CMP, the Departmental Appeals Board (Board) in a footnote suggested that the immediate jeopardy determination was not appealable but declined to address the appealability issue because CMS had not raised it as an issue.  Id. at 6-7 n.3. 
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                                                  3. The regulations governing long-term care facilities have been revised since the Seventh Circuit issued its decision in Fal-Meridian; the requirement that facilities minimize the risk of accidents is now found at 42 C.F.R. § 483.25(d).  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017).  However, the substance of the “quality of care” requirements – which are also statutory – has not changed, so decisions that pre-date the regulatory changes remain valid. 
                            - back to note 3
                                                  4. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. 
                            - back to note 4
                                                  5. The Minimum Data Set 3.0 Cognitive Function Scale, US National Library of Medicine, National Institutes of Health, published in final edited form as Med Care. 2017 Sep;55(9):e68-e72. 
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                                                  6. There are also conflicts in the record regarding the exact air temperature while R1 was outdoors (P. Br. at 5), and whether or not the windows in the secured unit were missing screws.  P. Br. at 10.  I do not find these conflicts to be material facts in dispute and, as noted below, have accepted Petitioner’s version of these facts for the purposes of summary judgment. 
                            - back to note 6
                                                  7. Interestingly, in a case decided after Estes in whicha resident was able to elope from the locked dementia unit by opening and crawling out of a window and to break three windows by throwing chairs, the Board did not discuss the foreseeability of breaking windows with a chair and instead upheld a violation, focusing on the lack of supervision provided.  Britthaven, Inc., DAB No. 2018 at 20 (2006). 
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                                                  8. The Administrative Law Judge in Estes stated that “[h]ad Petitioner put stop screws in its windows and done nothing else to protect against resident elopement I would be inclined to hold that its action was insufficient in light of evidence showing that the screws could be defeated by sufficient use of force.”  Estes, DAB CR1370 at 5.  Given that the instant case involved only window safety screws in a secured unit, Estes does not offer great support for Petitioner’s position. 
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                                                  9. While the immediate jeopardy determination will not be reviewed for the reasons discussed above, I noted Petitioner’s argument about the lack of evidence of potential harm to R1 and all other residents.  Petitioner’s argument that there was no other resident on the secured unit that had the strength to open a window normally is accepted (P. Br. at 13), but that does not address the very real concern that other residents on the secured unit could have eloped through the window after it had been opened by R1 prior to the time that the means of elopement was discovered. 
                            - back to note 9