Maryland Masonic Homes, DAB CR5608 (2020)

DECISION

Maryland Masonic Homes (Petitioner or facility), challenges the Centers for Medicare & Medicaid Services' (CMS's) determination that the facility was not in substantial compliance with the Medicare program participation requirement at 42 C.F.R. § 483.25(h)1 and that the cited noncompliance posed immediate jeopardy to resident health and safety.  Petitioner also challenges the civil money penalty (CMP) CMS imposed based on that alleged noncompliance.  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(h); CMS did not clearly err in determining that Petitioner's noncompliance with 42 C.F.R. § 483.25(h) posed immediate jeopardy; and the CMP, $10,291 per day for 54 days for a total CMP of $555,714, is reasonable in amount and duration.

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I.  Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Cockeysville, Maryland, that participates in the Medicare program as a provider of services.  See CMS Exhibit (Ex.) 1 at 1.  The Maryland Office of Health Care Quality (state agency) completed a recertification survey of Petitioner's facility on September 6, 2016.  Id.  Based on this survey, CMS concluded that Petitioner was out of substantial compliance with Medicare participation requirements and that the noncompliance represented immediate jeopardy to resident health and safety.  CMS Ex. 3 at 1-2.  CMS determined that the immediate jeopardy existed from July 10, 2016, through September 1, 2016.  Id. at 2.  CMS concluded that the immediate jeopardy was removed on September 2, 2016.  Id.  However, CMS cited other deficiencies at the non-immediate jeopardy level.  Id.  CMS determined that Petitioner returned to substantial compliance effective October 17, 2016.2

Based on the finding of substantial noncompliance, CMS imposed a CMP of $10,291 per day for 54 days of immediate jeopardy (July 10, 2016, through September 1, 2016) for a total CMP of $555,714.  Id.  Petitioner timely appealed and the case was assigned to me for a hearing and decision.

I issued an Acknowledgment and Prehearing Order, dated January 27, 2017 (Pre-hearing Order).  Pursuant to the Pre-hearing 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 Pre-hearing Order notified the parties that they must note objections to exhibits and request to cross-examine witnesses in the course of their prehearing exchanges.  Pre-hearing Order ¶¶ 7, 9.  CMS offered 17 proposed exhibits (CMS Exs. 1-17), including the written direct testimony of three witnesses (CMS Exs. 15-17).  Petitioner offered 8 proposed exhibits (P. Exs. 1-8), including the written direct testimony of two witnesses (P. Exs. 1, 6).  On December 4, 2017, CMS filed a motion for summary disposition, contending that there were no genuine issues of material fact in dispute and that CMS was entitled to judgment as a matter of law (CMS MSJ).  Petitioner opposed the motion (P. Opp.).  In a ruling issued January 29, 2018, I denied the motion for summary judgment.

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On February 20, 2018, I convened a hearing at the offices of the Departmental Appeals Board (DAB) in Washington, D.C.  The parties and CMS's witnesses appeared in person.  At the hearing, Petitioner cross‑examined Mark Gabel, R.N., Jennifer Cole, R.N., and Margaret Crosby, R.N., each of whom was employed by the state agency as a Health Facilities Surveyor Nurse.  Transcript (Tr.) at 21, 117, 130.  CMS did not request to cross‑examine Petitioner's witnesses.  See id. at 8.  Neither party objected to the exhibits offered by the opposing party.  Id. at 7.  In the absence of objection, I admitted into evidence CMS Exs. 1-17 and P. Exs. 1-8.  Id. at 8, 21, 116, 130.  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(h) (Tag F323, relating to accident prevention and adequate supervision) from July 10, 2016, through September 1, 2016;

If Petitioner was not in substantial compliance, whether CMS's determination that immediate jeopardy existed at the facility from July 10, 2016, through September 1, 2016, was clearly erroneous; and

If Petitioner was not in substantial compliance with program requirements, whether the CMP imposed ($10,291 per day) 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).

IV.  Discussion

A. Statutory and Regulatory Background

The Act sets forth requirements for SNFs to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  See Act § 1819 (42 U.S.C. § 1395i‑3); 42 C.F.R. parts 483 and 488.  To participate in the Medicare program, a SNF

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must maintain substantial compliance with program participation requirements.  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), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)), or the Secretary's regulations at 42 C.F.R. pt. 483, subpt. B.  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 program participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The regulations specify the enforcement remedies that CMS may impose.  42 C.F.R. § 488.406.  Among other enforcement remedies, CMS may impose a per-day CMP for the number of days a SNF is not in substantial compliance.  42 C.F.R. § 488.430(a).  For CMPs assessed after August 1, 2016, relating to noncompliance occurring after November 2, 2015, per-day CMPs could range from $103 to $6,188 per day for less serious noncompliance, or from $6,291 to $20,628 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  42 C.F.R. § 488.438(a)(1) (as updated at 81 Fed. Reg. 61538, 61557 (Sept. 6, 2016)).  "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.

If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge to challenge the noncompliance finding and enforcement remedy.  Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

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

1.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h) because Petitioner did not take all reasonable steps to ensure that the resident environment was as free of accident hazards as possible and that residents who were assessed as elopement risks were provided with adequate supervision and assistive devices to prevent their elopement from the facility.3

The quality of care regulation, 42 C.F.R. § 483.25, states generally that "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care."  Subsection 483.25(h) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:

(h) Accidents.  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.

In a number of decisions, appellate panels of the DAB have explained that subsection 483.25(h) 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"), aff'g Woodstock Care Ctr., DAB No. 1726 (2000)).4  As another appellate panel observed, "Though a facility has the flexibility to choose the methods of supervision and assistance used to prevent accidents, it must also 'provide supervision and assistance devices that

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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 (citing Century Care of Crystal Coast, DAB No. 2076 at 6-7 (2007), aff'd, Century Care of Crystal Coast v. Leavitt, 281 F. App'x 180 (4th Cir. 2008)).

CMS alleges that Petitioner failed to comply with 42 C.F.R. § 483.25(h) because it failed to secure an unlocked employee entrance on its basement level through which two cognitively impaired residents were able to exit the facility unsupervised.  See, e.g., CMS Post‑hrg. Br. at 9-11.  CMS points out that, from the date on which the residents exited through the employee entrance (July 10, 2016) until the recertification survey (September 2, 2016), Petitioner had not installed a locking mechanism on the employee entrance that would prevent residents from exiting.  Id. at 12.  CMS argues that this unsecured exit created a violation of 42 C.F.R. § 483.25(h) and placed Petitioner's residents in immediate jeopardy.  Id.

Petitioner does not dispute that the employee entrance was accessible to residents and unlocked.  See, e.g., P. Opp. at 4.  However, Petitioner contends that it employed other devices and supervision sufficient to protect its residents from the risks posed by the unlocked employee entrance.  P. Post‑hrg. Br. at 3-5.  Further, Petitioner argues that the finding of immediate jeopardy from July 10, 2016, through September 1, 2016, is clearly erroneous.  Id. at 6-11.

The weight of the evidence establishes that Petitioner did not comply substantially with 42 C.F.R. § 483.25(h).  As I explain in greater detail below, I find that, by failing to install a locking mechanism on its employee entrance, Petitioner did not take "all reasonable measures" to protect residents at risk for elopement.  See Briarwood, DAB No. 2115 at 11.  As such, Petitioner failed to "provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice."  Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (internal quotation marks omitted).

a. Facts

I find the following facts by a preponderance of the evidence.5  At the time of the survey (August 31, through September 6, 2016), Petitioner had a census of 67 residents, of

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whom 19 were assessed as wanderers or at risk for elopement.  CMS Ex. 1 at 1, 11; see also CMS Ex. 2 at 68; CMS Ex. 15 at ¶ 13.  Among other approaches and devices, Petitioner used a Wander Guard system6 to monitor some residents who were at risk for elopement.  P. Ex. 1 at ¶ 5.  Petitioner had Wander Guard sensors installed on each care unit (which I take to mean the halls on which residents reside), at the lobby entrance, and at the employee entrance in the basement of the facility.  Id.  If a resident wearing a Wander Guard bracelet triggered a sensor by approaching an exit, the system sounded an audible alarm and also transmitted the resident's identity and the location of the alarm to the nurse's station in each residence hall and to the security office.  Id.  Petitioner also employs security cameras to monitor the facility.  See id. at ¶ 6.

On July 10, 2016, two of Petitioner's residents, Resident 70 and Resident 97,7 left their residence hall, took the elevator to the basement and exited the facility through the employee entrance.  See, e.g., CMS Ex. 4 at 1.  In July 2016, Resident 70 was 92 years old; Resident 97 was 94 years old.  Both residents were cognitively impaired, and had medical histories that included wandering, falls, and poor safety awareness.  CMS Ex. 1 at 8, 10; CMS Ex 6 at 7, 20, 23; CMS Ex. 7 at 9-11, 13.  Resident 70 ambulated using a rolling walker.  CMS Ex. 4 at 13, 15; CMS Ex. 6 at 14.  Resident 97 ambulated using a wheelchair.  CMS Ex. 4 at 13, 14; CMS Ex. 7 at 10.

Upon leaving the residence hall and approaching the elevator, the residents triggered the Wander Guard alarm.8  CMS Ex. 4 at 1.  Petitioner's staff began to search for the

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residents, but did not initially know which way the residents had gone.9  Petitioner's security staff stated they did not observe the residents on the security cameras.  Id. at 5.  Nursing staff first looked for the residents on the second floor, then on the terrace level.  Id. at 13.  Not finding the residents in either of these locations, staff then proceeded to the basement, where the residents were still visible outside the glass doors.  Id.  The residents did not get far.  Petitioner's witness estimated that the residents were only about 10-15 feet from the entrance when staff located them.  P. Ex. 1 at ¶ 6.

A video recording captured by Petitioner's security system on July 10, 2016, shows the residents exit the elevator and approach the employee entrance.  P. Ex. 2 at 1:20.10  The entrance has a double set of glass doors.  P. Ex. 8 at 3.  Outside the employee entrance, just beyond the sidewalk, is a parking lot.  P. Ex. 2; P. Ex. 8; Tr. at 34.  In the video, Resident 97 can be seen pushing a button to the left of the inner doors.  P. Ex. 2 at 1:55‑2:00.  Resident 70 opens the inner door.  Id. at 2:09.  Both residents then make their way through the vestibule and exit the outer doors.  Id. at 2:09-3:20.  They head along the sidewalk away from the facility.  Id. at 3:50.  Shortly after they exit the facility, Resident 97's wheelchair appears to become stuck, but it is not possible to visualize what stopped her forward momentum.  Id. at 4:00.  Resident 70 attempts to push Resident 97's wheelchair, but is unable to free it.  Id. at 4:20.  Shortly thereafter, a staff member exits the elevator and approaches the residents.  Id. at 4:45-4:55.  The staff member returns the residents to the facility.  Id. at 4:55-5:55.   The entire episode elapsed within about five minutes.  P. Ex. 1 at ¶ 6; see also P. Ex. 2.

On August 6, 2016, Resident 97 again attempted to leave the facility via the employee entrance.  See, e.g., P. Ex. 5 at 2.  On this occasion, she did not succeed in exiting the facility because an employee in Petitioner's dietary department noticed the resident and prevented her from leaving.  Id.  See also P. Ex. 1 at ¶ 14.  Petitioner's dietary department (i.e., the kitchen) is located in the basement of the facility, close to the employee entrance.  P. Ex. 1 at ¶ 15.

Following the July 10, 2016 incident, Petitioner conducted retraining of staff on elopement policies and procedures.  Id. at ¶ 8.  On July 29, 2016, Petitioner sent three of its managers to a "train the trainer" program on dementia care, sponsored by the Alzheimer's Association.  Id. at ¶ 9.  From August 10, through August 13, 2016, one of the managers who attended the training conducted mandatory training of the nursing staff

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covering the subject matter.  Id.  Petitioner also updated the care plans of Resident 70 and Resident 97 to reflect that they were at risk due to their wandering behavior.  Id. at ¶ 10.

Petitioner did not, however, modify the employee entrance to prevent residents from using it to exit the facility.  Petitioner's Executive Director, Tammie Houck, testified that the facility "immediately made the decision to install electronic card readers on the employee entrance doors in the basement, so that only employees with badges could unlock the doors to exit the building through the doors."  Id. at ¶ 11 (italic type added).  I read this statement to imply that "immediately" means in response to the July 10, 2016 incident.  Despite this implication, Ms. Houck admitted that Petitioner had not yet completed installing the card readers on the employee entrance as of September 2, 2016.  Id. at ¶ 13.  Ms. Houck additionally confirmed that she mistakenly believed the installation had been completed earlier.  Id. at ¶ 12.

b. Analysis

Petitioner urges me to conclude that it substantially complied with 42 C.F.R. § 483.25(h) because it had provided Resident 70 and Resident 97 with functioning Wander Guard bracelets and because Petitioner's staff responded when the Wander Guard alarms sounded.  P. Post‑hrg. Br. at 2.  I agree with Petitioner to this extent:  the Wander Guard system worked as it was designed to do.  It sounded an audible alarm when the residents left their residence hall and approached the elevators.  See, e.g., CMS Ex. 4 at 1. Petitioner's staff responded by searching for the residents.  Id.  However, the July 10 incident underscored, or should have, that the Wander Guard system alone was not sufficient to keep Petitioner's residents from eloping.  During the July 10 incident, staff did not immediately know where to look for the residents, although the Wander Guard system had the ability to transmit this information.  For this reason, Petitioner's reliance on Willow Creek Nursing Ctr., DAB No. 2040 (2006), aff'g DAB CR1351 (2005), is misplaced.  See P. Post‑hrg. Br. at 3-5.

In Willow Creek, the administrative law judge concluded that the facility adequately supervised a wandering resident because facility staff, at all times, kept the resident in sight, even when he briefly went outside the facility.  See DAB CR1351 at *4.11  Based on these facts, the administrative law judge concluded that the facility substantially complied with 42 C.F.R. § 483.25(h) and the appellate panel agreed.  In the present case, by contrast, for approximately four to five minutes on July 10, 2016, Petitioner's staff did not know where Resident 70 and Resident 97 had gone.  Had a resident more capable and mobile than either Resident 70 or Resident 97 accessed the elevator and the employee

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entrance, such a resident could have eluded the efforts of Petitioner's staff to locate him or her.

Petitioner essentially admits that the Wander Guard system alone was not sufficient to prevent residents from eloping through the employee entrance.  In the wake of the July 10, 2016 incident involving Resident 70 and Resident 97, Petitioner "immediately made the decision" to modify the employee exit by installing a locking device with a card reader.  P. Ex. 1 at ¶ 11.  Yet, on September 2, 2016, when the surveyors investigated the incident involving Resident 70 and Resident 97, the card reader was not yet fully functional.12  CMS Ex. 1 at 10; see also P. Ex. 1 at ¶ 13.

Based on the foregoing, I conclude that Petitioner did not take all reasonable measures to remove accident hazards and protect its residents from eloping and that this failure put Petitioner's residents at risk for more than minimal harm.  Thus, Petitioner was not in substantial compliance with the requirements of 42 C.F.R. § 483.25(h).13  I next consider whether CMS's finding that Petitioner's noncompliance placed the facility's residents in immediate jeopardy was clearly erroneous.

2.  CMS's immediate jeopardy determination was not clearly erroneous.

CMS concluded that Petitioner's violation of 42 C.F.R. § 483.25(h) constituted an isolated incidence of immediate jeopardy to resident health and safety (scope and severity "J"), from July 10 through September 1, 2016.  CMS Ex. 3 at 1-2.  Petitioner argues that the finding of immediate jeopardy is clearly erroneous.  P. Post‑hrg. Br. at 6-11. I disagree.

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Petitioner attacks CMS's finding of immediate jeopardy by attempting to undermine the state agency surveyors' determination that serious harm to residents was likely to occur as a result of the unlocked employee entrance.  In particular, Petitioner contends that the testimony of surveyor Mark Gabel is too speculative to establish that serious harm was likely as a result of Petitioner's noncompliance.  Id.  If Petitioner's point is that a finding of immediate jeopardy requires the decision-maker to conclude that serious harm is more than merely possible, I agree.  Appellate panels of the DAB have reasoned that the use of the term "likely" in the regulation means that an event must be more than just possible or "potential."  See, e.g., Franklin Care Ctr., DAB No. 2869 at 9 (2018) (an immediate jeopardy deficiency is one that creates more than a potential for or possibility of serious harm or death; it must have either caused actual serious harm, impairment, or death, or have been likely to cause that result); see also Daughters of Miriam Ctr., DAB No. 2067 at 10 (2007).  Nevertheless, Petitioner's arguments seeking to discredit surveyor Gabel's opinion misunderstand the place of a surveyor's testimony in nursing home enforcement proceedings.

The principal purpose of a surveyor's testimony is to establish the facts that existed at the facility at the time of the survey ‒ not to opine on the ultimate questions of law.14  Whatever may be in a surveyor's mind when he or she (and possibly others within the state agency) decides to cite a deficiency and decides what scope and severity to assign, that initial decision is merely a recommendation to CMS.  See, e.g., Britthaven of Chapel Hill, DAB No. 2284 at 6-7 (2009) (state agency merely recommends a finding of compliance or noncompliance; CMS ultimately determines whether the facility is in substantial compliance and whether immediate jeopardy exists).  Accordingly, "the quality of the surveyors' information gathering or thought processes is immaterial."  Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 33 (2011).  I therefore do not evaluate the quality of surveyor Gabel's thought processes during (or after) the survey.

Furthermore, when it comes to the level of noncompliance, I may not overturn a finding of immediate jeopardy unless I conclude the finding was clearly erroneous.  42 C.F.R. § 498.60(c)(2).  Appellate panels of the DAB have interpreted section 498.60(c)(2) as creating a presumption that CMS's finding of immediate jeopardy is correct:

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

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Daughters of Miriam Ctr., DAB No. 2067 at 7.  Thus, the clearly erroneous standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy.  Id.; see also Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff'd, Barbourville Nursing Home v. U.S. Dep't of Health & Human Servs., 174 F. App'x 932 (6th Cir. 2006).

Taken together, the authorities just discussed direct me to determine whether Petitioner has proved facts sufficient to overcome the presumption that CMS correctly cited Petitioner's noncompliance at the immediate jeopardy level.  Put another way, I may set aside the finding of immediate jeopardy only if, after reviewing all the evidence, I am "left with the definite and firm conviction that a mistake has been committed."  Easley v. Cromartie, 532 U.S. 234, 242 (2001).  Having reviewed the evidence, I am not left with the definite and firm conviction that the finding of immediate jeopardy was mistaken.  To the contrary, I conclude that the finding of immediate jeopardy must be sustained because it was not clearly erroneous.

The facts (as opposed to opinions) to which Petitioner directs my attention in support of its position that the immediate jeopardy determination was clearly erroneous are these:

• Resident 70 and Resident 97 were wearing Wander Guard bracelets that triggered an alarm when the residents approached the elevators on July 10, 2016;
• Petitioner's staff responded to the alarm and began searching for the residents;
• Staff located the residents within about five minutes.
• Resident 70 and Resident 97 were only 10-15 feet outside the employee entrance when staff located them and returned them to the facility;
• Resident 70 and Resident 97 were not injured when they left the facility;
• Resident 97 did not succeed in exiting the facility on August 6, 2016;
• No residents other than Resident 70 and Resident 97 eloped or attempted to elope through the unlocked employee entrance during the period July 10 through September 1, 2016;
• A road, a pond, and a steep hill, though located on Petitioner's property, are on the other side of the building from the unlocked employee entrance.

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See, e.g., P. Post‑hrg. Br. at 7-8; P. Post‑hrg. Reply at 8.  From these facts, Petitioner posits that serious harm to its residents was "extremely unlikely."15  P. Post‑hrg. Br. at 6 (emphasis in original).  I do not view these facts as so benign.

First, despite the fact that Resident 70 and Resident 97 were equipped with functioning Wander Guard bracelets and even though staff responded when the Wander Guard alarm sounded, it is undisputed that staff did not know the whereabouts of Resident 70 and Resident 97 for a period of time.  While staff were aware that the residents had entered the elevator, staff had no way of knowing whether the residents had gone up or down.  P. Br. at 9 n.10.  In Petitioner's view, the fact that staff located the residents within about five minutes demonstrates that the residents were never at risk.  This assumes that the residents could not encounter any risks of serious harm within a five-minute period or until they exited Petitioner's building.  However, upon learning the residents could not be located, at least one member of Petitioner's staff was concerned that the residents would risk injury if they accessed "the ramp."  CMS Ex. 4 at 16.  The record does not provide details on the location or purpose of the ramp in question.  Yet, this suggests that there were some environmental hazards within Petitioner's facility to which the residents could have gained access in a short time.16

Moreover, five minutes is enough time for a resident or residents to elude staff's search.  Even in the case of Resident 70 and Resident 97, it was merely fortuitous that they were still visible when staff responded to the employee entrance.  As the security video plainly shows, Resident 70 and Resident 97 ambulated very slowly.  P. Ex. 2.  Yet, even at their slow pace, they were able to exit the facility onto a sidewalk next to a parking lot before staff could intervene.  Moreover, had Resident 97's wheelchair not become stuck, the residents could have proceeded out of sight of the doors or into the parking lot itself before staff reached them.  In either instance, the residents would have been at serious risk.

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Cognitively impaired individuals with poor safety awareness might well wander into the path of a moving vehicle in the parking lot.  See Britthaven, Inc., d/b/a Britthaven of Smithfield, DAB No. 2018 at 21 (2006) (the fact that resident did not get far "does not mean she was not exposed to serious harm or even death" since she was exposed to danger from cars in the parking lot, among other risks).  Further, had the residents been out of sight when staff responded to the employee entrance, staff may have searched inside the basement level of the facility before searching outside.  Although Petitioner downplays the possibility, any additional delay in the search may have provided the residents time enough to access the environmental hazards on the other side of the building, such as the pond, the steep hill, and, ultimately, the road.  Had they done so, they would have encountered several risks of serious harm, such as falling on the hill or into the pond on Petitioner's property or to the risk of being struck by a car on the adjacent road.

Second, Petitioner fails to account for the fact that, if Resident 70 and Resident 97, with their limited mobility, were able to get as far as they did before being intercepted, it was likely that, had a wandering resident without their limitations accessed the employee entrance, he or she would almost certainly have been out of sight within the five minutes that elapsed.  Once out of staff's sight, such a resident would be exposed to the dangers of the parking lot, as well as the risks posed by the hill, the pond, and the road described above.  Facility records identified 17 other residents, in addition to Resident 70 and Resident 97, who were wanderers or at risk for elopement.  CMS Ex. 1 at 1, 11; see also CMS Ex. 2 at 68; CMS Ex. 15 at ¶ 13.  For all those residents, the unlocked employee entrance created a similar risk to that addressed in Brightview Care Ctr., DAB No. 2132 (2007).  In that case, a resident eloped through a monitored door, due to an employee's inattention.  The appellate panel observed that the facility's noncompliance not only affected the particular resident who eloped, but "the problem also placed at risk the other residents who had the potential to elope.  Until an effective system was in place, it was likely that other vulnerable residents might also leave the premises by similar means."  Id. at 20.  So too, in the present case, as long as Petitioner's employee entrance was unlocked and accessible, "it was likely that other vulnerable residents might also leave the premises by similar means."  Id.

The fact that no other resident succeeded in eloping following the July 16, 2016 incident does not compel a contrary conclusion.  Rather, the fact that Resident 97 again attempted to elope on August 6, 2016, underscored the risk posed by Petitioner's unlocked employee entrance.  Resident 97's second attempt to exit the facility made it more likely ‒ not less so ‒ that she or another wandering resident would eventually succeed in eloping through the employee entrance, if it remained unsecured.  See, e.g., Bigfork Valley Communities, DAB CR4942 (2017) (noncompliance at the immediate jeopardy level was present even though no resident had yet succeeded in eloping). As an appellate panel of the DAB has observed, "For a risk to be foreseeable, it need not have been made

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obvious by having already materialized."  Josephine Sunset Home, DAB No. 1908 at 14‑15 (2004).

For the reasons explained above, I find that CMS did not clearly err in concluding that Petitioner's noncompliance posed immediate jeopardy to its residents.

3.  A CMP of $10,291 per day for the period of immediate jeopardy from July 10, 2016, through September 1, 2016, is reasonable.

I evaluate whether a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f):  1) the facility's history of noncompliance; 2) the facility's financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  The factors listed in § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).

The regulations specify that a per-day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,291 to $20,628 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2).17  The lower range of a CMP, $103 to $6,188 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii).  In assessing the reasonableness of a CMP amount, an administrative law judge considers the per-day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC,DAB No. 2186 at 28 (2008).  The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place,DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC,DAB No. 2186 at 28-29.

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In this case, CMS imposed a CMP of $10,291 per day for 54 days of immediate jeopardy (July 10, 2016, through September 1, 2016).  CMS argues that the CMP amount is reasonable.  CMS Post‑hrg. Br. at 23-24.

Petitioner argues that the CMP is unreasonable because it is inconsistent with CMS policy guidance and with CMP amounts imposed in other cases.  On these bases, Petitioner argues that both the imposition of a CMP and the amount are arbitrary and capricious.  P. Post‑hrg. Br. at 11-12.

It is well-settled that administrative law judges and appellate panels of the DAB "properly presume[] that CMS considered the regulatory factors and that those factors support the amount imposed."  Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 23 (2012) (underscore in original).  Thus, CMS is not required to present evidence regarding the section 488.438(f) factors.  Instead, the burden is on Petitioner "'to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.'"  Id. (emphasis added) (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 26-27 (2011)).  Further, unless a facility presents evidence and argument that a particular regulatory factor does not support the CMP amount, an administrative law judge must sustain it.  Coquina Ctr., DAB No. 1860 at 32.

Here, Petitioner has offered neither argument nor evidence addressing the regulatory factors.  For example, Petitioner has not argued that the CMP is unreasonable based on its compliance history or financial condition.  To the contrary, the bases on which Petitioner challenges the CMP are not ones which I may consider in this proceeding.

First, Petitioner argues that the CMP amount is unreasonable because it is "orders of magnitude higher than what [CMS] has imposed in previous cases."  P. Post‑hrg. Br. at 11.  No regulatory factor in 42 C.F.R. § 488.438(f) or 42 C.F.R. § 488.404 authorizes me to consider what CMP amount CMS has imposed on other facilities, based on other facts, in evaluating the CMP imposed in this case.18

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Next, Petitioner argues that, based on CMS internal memoranda, CMS should have imposed a per‑instance CMP rather than a per‑day CMP.  P. Post‑hrg. Br. at 12.  Petitioner's argument that CMS should not have imposed a per‑day CMP is specifically foreclosed under the applicable regulations.  A finding by CMS of noncompliance leading to the imposition of a remedy is an initial determination subject to administrative review.  42 C.F.R. § 498.3(b)(13).  However, "the determination as to which sanction was imposed" is not such an initial determination.  Id.

Finally, Petitioner's contention that I may overturn the CMP in this case as "arbitrary and capricious" (P. Post‑hrg. Br. at 12) misunderstands my role as an administrative law judge in the administrative appeal process.  The arbitrary and capricious standard, codified in the Administrative Procedure Act (APA), is a standard for court review of final agency actions.  5 U.S.C. § 706.  My role differs from that of a federal court reviewing final agency actions.  In administrative proceedings governed by 42 C.F.R. Part 498, CMS's noncompliance findings and selection of remedy are not final agency actions.  Nor is my decision reviewing those determinations.  See 42 C.F.R. § 498.90 (providing that the appellate decision of the DAB is the final agency action that may be appealed to federal court).  As an appellate panel of the DAB held in Hanover Hill Health Care Ctr., "[n]othing in the APA . . . applies the 'arbitrary and capricious standard' to Board review of an [administrative law judge] decision on behalf of the Secretary . . . ."  DAB No. 2507 at 7 (2013); see also Cal Turner Extended Care Pavilion, DAB No. 2030 at 7 (2006) (discussing "the distinction between the oversight role of a federal court reviewing agency decisions to determine if an adequate basis is articulated and the internal agency appeals process for formulating final agency action").

My role in this administrative proceeding is to determine, based solely on the factors enumerated in the regulations, whether the CMP amount is reasonable.  Applying those factors, I find that Petitioner's noncompliance in this case was serious, and that Petitioner was culpable (i.e., responsible) for the noncompliance.  As discussed above, Petitioner failed to secure its employee entrance, even though Petitioner's management was aware residents could access the entrance and exit the facility.  Petitioner's management was aware of this potential because Resident 70 and Resident 97 in fact exited the facility through the employee entrance.  It is fortunate that these residents were located quickly and were unharmed.  However, had another, more mobile resident eloped through the employee entrance, that resident may not have been so fortunate.  This put all 19 of Petitioner's residents who were prone to wander or elope at serious risk of harm or death.

The $10,291 per-day CMP that CMS imposed is in the lower one-third of the CMP range for immediate jeopardy level deficiencies ($6,291 to $20,628 per day).  42 C.F.R. § 488.438(a)(1)(i), (d)(2).  I find that a CMP in the lower one-third of the immediate jeopardy range is reasonable, given the seriousness of the noncompliance.

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Petitioner has not argued (should I find immediate jeopardy existed) that it abated the immediate jeopardy earlier than September 2, 2016.  Accordingly, I find that the duration of the CMP, from July 10, 2016 through September 1, 2016, is reasonable.

4.  Other issues raised by Petitioner are not within my authority to decide.

Finally, in its Pre-hearing Brief, Petitioner raised several statutory and Constitutional challenges to the CMP imposed in this case.  P. Br. at 14.  Among other things, Petitioner argued that, by applying the inflation-adjusted CMP amounts retroactively and by publishing and enforcing those amounts without notice and comment, CMS violated the Administrative Procedures Act and the ex post facto clause of the Unites States Constitution, as well as depriving Petitioner of its right to due process of law under the Fifth and Fourteenth Amendments of the United States Constitution.  Id.  I do not have authority to adjudicate these claims.  CMS applied the inflation-adjusted CMP amounts prescribed by statute and regulation.  I must do the same.  Administrative law judges are required to follow the Act and regulations and have no authority to declare statutes or regulations invalid.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009) (administrative law judge "is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground, even a constitutional one.").

V.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h).  I further conclude that CMS's determination of immediate jeopardy for the period of July 10 through September 1, 2016, was not clearly erroneous.  The CMP of $10,291 per day effective July 10 through September 1, 2016, is reasonable in amount and duration.

• 1. Effective November 28, 2016, 42 C.F.R. § 483.25(h) was redesignated as 42 C.F.R. § 483.25(d).  81 Fed. Reg. 68,688, 68,860 (October 4, 2016).  I cite to the version of the regulation that was in effect at the time the findings of substantial noncompliance were issued.  See Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey).
• 2. CMS's notice imposing the CMP did not explicitly state that Petitioner achieved substantial compliance effective October 17, 2016.  CMS Ex. 3 at 1-2.  I infer Petitioner did so because the CMP stopped accruing as of October 16, 2016.  Id. at 2.  CMS imposed a CMP of $203 per day for 45 days of non-immediate jeopardy noncompliance (from September 2, 2016, through October 16, 2016) for a total CMP of $9,135.  Id.  Petitioner did not challenge the noncompliance findings at the non-immediate jeopardy level.  See Summary of Prehearing Conference and Notice of Hearing at 2 (Docket Entry # 14 in E‑File).  I therefore do not address these findings further.
• 3. My conclusions of law appear as headings in bold italic type.  My findings of fact appear in the accompanying text.
• 4. The appellate panel in Briarwood focused its discussion on whether the facility complied substantially with 42 C.F.R. § 483.25(h)(2).  The same reasoning would seem equally applicable to subsection 483.25(h)(1), however.  Moreover, at least one appellate panel has opined that the duty to take all reasonable steps applies to 42 C.F.R. § 483.25(h) as a whole.  See Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017).
• 5. The facts concerning the events of July 10, 2016 and August 6, 2016, are largely undisputed.  Nor is there any real dispute that the magnetic card locking mechanism for the employee entrance was not fully operational until after the survey in September 2016.  The only truly disputed facts relate to the question of whether Petitioner's unlocked employee entrance posed immediate jeopardy to Petitioner's residents.  In particular, Petitioner disputes that the unlocked entrance was "likely to cause, serious injury, harm, impairment, or death to a resident" of the facility.  I discuss this issue further in section IV.B.2, below.
• 6. Wander Guard is a security system that sounds an alarm when a resident wearing an electronic bracelet approaches or tries to exit through a door connected to the system.  Petitioner's records at times refer to the system as a "code alert."  See, e.g., CMS Ex. 6 at 14, 21.
• 7. To protect their privacy, I refer to the residents by the numerical identifiers assigned during the survey.  See CMS Ex. 2 at 4.
• 8. The Statement of Deficiencies suggests that Resident 70 did not have an order for a Wander Guard bracelet until after the July 10 incident.  CMS Ex. 1 at 10.  Petitioner's self-report of the incident states that both residents were wearing Wander Guard bracelets on July 10.  CMS Ex. 4 at 1-2.  I find it is more likely than not that Resident 70 was equipped with a Wander Guard or code alert bracelet on July 10, 2016.  Petitioner's treatment records for Resident 70 covering the month of July, 2016 show that staff checked the placement of a "code alert bracelet" on each day of the month, including July 10, 2016.  CMS Ex. 6 at 14.
• 9. As Petitioner explains, "The Baltimore Hall sensor was the sensor that the resident[s] triggered before getting on the elevator.  Nurse Nunamaker could not have known which direction on the elevator they were headed."  P. Br. at 9 n.10.
• 10. I cite to the elapsed time displayed on the video player.  It does not appear that the security surveillance video recorded contemporaneous time markings.
• 11. I cite to the page numbering as the decision appears in Westlaw (2005 WL 2470109).
• 12. Petitioner argues that it could not "immediately" complete the installation of the card reader because the fire department needed to verify that the door locks would release in the event of fire.  P. Br. at 4-5; P. Opp. at 7.  Petitioner does not explain, however, why this additional step could not have been completed closer in time to July 10, 2016, or why it was not completed until after the surveyors pointed out the problem.  Given management's mistaken impression that the repairs had already been completed, it is unclear when, if ever, the modification would have been completed if the survey had not intervened.
• 13. I need not decide whether Petitioner's noncompliance violated subsection 483.25(h)(1) or 483.25(h)(2), or both, because the deficiency, as cited, covers both subsections.  Petitioner's noncompliance encompassed elements of inadequate supervision as well as the failure to correct a known hazard (the unlocked employee entrance).  However, I note that, even if it could be argued that Petitioner's functioning Wander Guard system represented compliance with subsection 483.25(h)(2), this would not alter the noncompliance with subsection 483.25(h)(1).
• 14. A surveyor's role is not altered by qualifying him or her as an expert witness.  Even an expert witness' opinion does not extend to the ultimate questions of law to be decided by the judge.  See, e.g., Lake Park Nursing & Rehab. Ctr., DAB No. 2035 at 18 (2006).
• 15. Petitioner also contends that the July 10, 2016 incident does not meet the guidelines for citing immediate jeopardy that CMS has published in the State Operations Manual (SOM).  P. Post‑hrg. Br. at 6.  The SOM represents CMS guidance to its internal components and to the state agencies that conduct surveys on its behalf.  Such guidance does not have the force and effect of law and is not binding on me.  Foxwood Springs Living Ctr., DAB No. 2294 at 8-9 (2009).
• 16. In Asbury Ctr. at Johnson City, DAB No. 1815 (2002) a wheelchair-bound resident fell down a flight of stairs, sustaining injuries that ultimately led to her death.  Similarly, Resident 97, who used a wheelchair to ambulate, could have sustained a fall from the ramp, resulting in serious injury.
• 17. The CMP ranges listed in the regulations are adjusted annually for inflation under 45 C.F.R part 102.  The amounts I cite here were those in effect at the time CMS imposed the remedies at issue in the present case.  See 81 Fed. Reg. 61538, 61557 (Sept. 6, 2016).
• 18. While not a factor in my review, I note that the higher CMP amount in this case resulted, at least in part, because Congress passed the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Public Law 114–74, November 2, 2015).  Among other things, this legislation required federal agencies to adjust the level of CMPs with an initial "catch‑up" adjustment through an interim final rulemaking.  See 81 Fed. Reg. 61,538.  For CMPs within HHS jurisdiction, the interim final rule incorporating the "catch‑up" adjustment was made applicable to CMPs assessed after August 1, 2016, whose associated violations occurred after November 2, 2015.  Id.  Petitioner implicitly acknowledges that this inflation adjustment likely played a role in the CMP amount assessed.  P. Post-hrg. Br. at 11 n.15.