Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Asheville Health Care Center
(CCN: 34-5418),

Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-08-429
Decision No. CR2214

Date: August 13, 2010

DECISION

Petitioner, Asheville Health Care Center (Asheville), challenges the decision of the
Centers for Medicare and Medicaid Services (CMS) that it was not in substantial
compliance with program participation requirements. Petitioner also challenges CMS’s
imposition of remedies, which includes: a civil money penalty (CMP) totaling $266,600;
and loss of Petitioner’s ability to operate a nurse aide training and competency evaluation
program (NATCEP) for two years. For the reasons discussed below, I find that Petitioner
was out of substantial compliance with participation requirements during the relevant
period. In addition, I find that Petitioner’s noncompliance with 42 C.F.R. § 483.25(h)
posed immediate jeopardy, and the remedies imposed are reasonable.

I. Background

Asheville is a skilled nursing facility (SNF) in Swannanoa, North Carolina. On February
4-7, 2008, the North Carolina State Survey Agency (State Agency) completed a
recertification and complaint investigation survey at Petitioner’s facility to determine if
Asheville was in compliance with Federal participation requirements for nursing homes
participating in the Medicare and Medicaid programs.
By letter dated March 5, 2008, CMS notified Petitioner that it was out of substantial
compliance with participation requirements of the Medicare and Medicaid programs, and
that conditions in the facility constituted immediate jeopardy to resident health and safety,
as well as substandard quality of care. The survey also found that corrective action was
taken, and the immediate jeopardy was abated. Accordingly, CMS imposed remedies
that included: a CMP of $3,550 per day effective November 24, 2007 through February
6, 2008, the period in which immediate jeopardy conditions were present; a CMP of $100
per day effective February 7, 2008, which was to continue until substantial compliance
was achieved or Petitioner was terminated; a denial of payment for new admissions
(DPNA) effective March 20, 2008, if Petitioner was still out of substantial compliance on
that date; loss of NATCEP; and mandatory termination on August 7, 2008, in accordance
with 42 C.F.R. § 489.53. CMS Exhibit (Ex.) 2, at 2-3.

Following a revisit survey and a complaint investigation on March 11-12, 2008, CMS
notified Petitioner by letter, dated March 28, 2008, that Petitioner remained out of
substantial compliance at a non-immediate jeopardy level. CMS Ex. 2, at 5-6. Asa
result, the CMP of $100 per day effective February 7, 2008 would continue until
substantial compliance was achieved or the provider agreement was terminated. In
addition, the DPNA remained in effect March 20, 2008, and mandatory termination of the
provider agreements was effective August 7, 2008, if the facility remained out of
substantial compliance on that date. Jd. at 6-7.

The State Agency conducted a revisit on March 27, 2008 and found Petitioner in
substantial compliance, effective March 17, 2008. Jd. at 9. As a result, CMS cancelled
the DPNA and termination action. Jd. Thus, the CMP of $3,550 per day was in effect for
74 days, and the CMP of $100 per day was in effect for 39 days, for a total CMP of
$266,600.

Petitioner first used the Informal Dispute Resolution Process (IDR) to dispute the
deficiency of Tag F 323. CMS Ex. 4, at 1. By letter dated April 9, 2008, the IDR panel
decision upheld the F 323 deficiency and stated, in pertinent part:

Based on review of the statement of deficiency dated 2/7/08 and
information provided by the facility, the following facts are not disputed:

The resident exited the building unsupervised on 10/19/07 and 11/24/07.
Nursing documentation of 10/19/07 prior to exit noted escalation of
paranoia and confusion.

The resident became an elopement risk when she exited the building
10/19/07.

No evidence of acute monitoring following the 10/19/07 elopement was
noted by nursing.

No evidence of acute monitoring following the 10/19/07 elopement was
made available.
No assessment of elopement risk was completed until 11/20/07 after the
second exit.

Nursing staff failed to communicate occurrences to administrative staff.
Resident Council members voiced concerns related to security due to
residents who had gotten out of the facility unsupervised.

The time the resident was out of the building for each exit was
undetermined.

The resident was a compromised individual with variable cognition who
voiced intent to go home on 10/19/07, and to go across the road 11/24/07.
The facility provided a statement that acute monitoring occurred after the
10/19/07 elopement. However, evidence of monitoring was not provided to
the survey team or to the IDR panel members in the supporting
documentation submitted by the facility and received on 03/05/08. No
additional information refuting the 2567 [Statement of Deficiencies] was
presented to the IDR panel for review.

CMS Ex. 5, at 2.

Petitioner requested a hearing by letter dated May 5, 2008. This case was initially
assigned to Administrative Law Judge (ALJ) Jose A. Anglada on May 8, 2008. In
accordance with the briefing schedule of ALJ Anglada’s initial order, CMS filed an
exhibit list, pre-hearing brief, and exhibits on September 11, 2008. Petitioner filed the
same on October 10, 2008. On February 19, 2009, this case was transferred to me for
earing and decision. On April 24, 2009, I set a hearing date of August 31 — September
4, 2009, which was held in Asheville, North Carolina. A 1,136-page transcript (Tr.) of
the hearing was prepared. Both parties submitted briefs and reply briefs (CMS and P.
Reply). I admitted P. Exs. 1-9 and CMS Exs. 1-37. Testifying for CMS were State
Agency surveyors Deborah Robinson, Janet Spivey, and Karen Roquemore. Testifying
or Petitioner were: Ronald Allen, Petitioner’s Environment Service Director (supervisor
or housekeeping and laundry); Jill Dixon, licensed practical nurse (L.P.N.); Cynthia
Brantley, Geriatric Nurse Practitioner; Blair Holl, M.D., Petitioner’s Medical Director;
Maureen Davis, Petitioner’s Administrator; and Connie Cheren, R.N., MS.w.,!

Petitioner presented Ms. Cheren as an expert witness for the survey and certification
processes for nursing homes participating in the Medicare and Medicaid programs. Tr. at
821. CMS did not object at the hearing. Tr. at 823. However, CMS argues in its post-
hearing reply brief that no weight should be given to Ms. Cheren’s testimony because it
was irrelevant and not credible. CMS Reply Br. at 9. I agree. I did not find Ms.
Cheren’s testimony to constitute an expert opinion. For example, Ms. Cheren asserted
that R6 did not leave a safe area or the facility premises, because R6 was not harmed or
injured during the elopement. Tr. at 837-38, 1084. Whether harm or injury occurred is
irrelevant to a violation of 42 C.F.R. § 483.25(h). See supra Part IV. As another

(...Continued)
President and Owner of Quality Care Assurance, a company that provides consultative
services to nursing homes.

II. Issues

1. Whether Petitioner was out of substantial compliance with Medicare participation
requirements; and

2. If Petitioner was out of substantial compliance with 42 C.F.R. § 483.25(h) (Tag
F323), whether CMS’s determination that Petitioner’s noncompliance posed
immediate jeopardy to the health and safety of the residents was clearly erroneous;
and

3. If Petitioner was out of substantial compliance with participation requirements,
whether the remedies imposed are reasonable.

Ill. Applicable Law

Petitioner is considered a long-term care facility under the Social Security Act (Act) and
regulations promulgated by the Secretary of the Department of Health and Human
Services (Secretary). The statutory requirements for participation by a long-term care
facility are found at section 1819 and 1919 of the Act, and at 42 C.F.R. Part 483.
Sections 1819 and 1919 of the Act vest the Secretary with authority to impose CMPs and
other remedies against a long-term care facility for failure to comply substantially with
participation requirements.

(Continued...)

example, Ms. Cheren defined the term “premises” to determine elopement as an area
within property lines. Tr. at 837-38. She stated that she based that definition on both her
experience regulating nursing homes and being involved in nursing home cases, as well
as on definitions found in Webster’s Dictionary. Tr. at 835, 1078. That definition is
contrary to the facts of numerous cases where elopements were found based on a
resident’s undetected exit from the facility itself. Further, the purpose of the regulation is
not whether an accident (or elopement) occurs, as Ms. Cheren emphasized. Rather, it is
whether the facility has provided supervision and assistance devices adequate to prevent
an accident. Kenton Healthcare, LLC, DAB No. 2186, at 12 (2008) (refusing to
determine whether all of the exits were “elopements,” because the issue is not the exits
per se, or whether the resident was found on or off facility property, but the lack of
supervision that resulted in the exits). Ms. Cheren did not provide testimony that I
consider expert opinion, and I do not give her testimony the weight of an expert opinion.
Pursuant to the Act, the Secretary has delegated to CMS the authority to impose various
remedies against a long-term care facility that is not complying substantially with federal
participation requirements. State survey agencies, on behalf of CMS, may survey
facilities that participate in Medicare to ascertain whether the facilities are complying
with participation requirements. 42 C.F.R. §§ 488.10 —.28, 488.300 — .335. Under Part
488, CMS may impose a per instance, or per day, CMP against a long-term care facility,
when a State survey agency ascertains that the facility is not complying substantially with
participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430. The regulations in
42 C.F.R. Part 488 also give CMS a number of other remedies that can be imposed if a
facility is not in compliance with Medicare requirements.

Pursuant to 42 C.F.R. Part 488, CMS may terminate a long-term care facility’s provider
agreement, when a survey agency concludes that the facility is not complying
substantially with federal participation requirements. CMS may also impose a number of
alternative enforcement remedies in lieu of, or in addition to, termination. 42 C.F.R.

§§ 488.406, 488.408, 488.430. In addition to termination and the alternative remedies
that CMS is authorized to impose, pursuant to section 1819(h)(2)(D) of the Act and 42
C.F.R. § 488.417(b), CMS must impose the “mandatory” or “statutory” DPNA. Section
1819(h)(2)(D) requires the Secretary to deny Medicare payments for all new admissions
to a SNF, beginning three months after the date on which such facility is determined not
to be in substantial compliance with program participation requirements. The Secretary
has codified this requirement at 42 C.F.R. § 488.417(b).

The regulations specify that a CMP that is imposed against a facility on a per-day basis
will fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The
upper range of the CMP, from $3,050 per day to $10,000 per day, is reserved for
deficiencies that constitute 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). The lower
range of CMP, from $50 per day to $3,000 per day, is reserved for deficiencies that do
not constitute 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). There is only a single range of $1,000 to $10,000 for a per instance
CMP, which applies whether or not immediate jeopardy is present. 42 C.F.R.

§§ 488.408(d)(1)(iv); 488.438(a)(2).

The regulations define the term “substantial compliance” to mean “a level of compliance
with the requirements of participation, such that any identified deficiencies pose no
greater risk to resident health or safety than the potential for causing minimal harm.” 42
C.F.R. § 488.301. Immediate jeopardy is defined as “a situation in which the provider’s
noncompliance with one or more requirements of participation has caused, or is likely to
cause, serious injury, harm, impairment, or death to a resident.” Jd. The Act and
regulations make a hearing before an ALJ available to a long-term care facility against
which CMS has determined to impose a CMP. Act Section 1128A(c)(2); 42 C.F.R. §§
488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding.
Anesthesiologists Affiliated, DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991).
A facility has a right to appeal a “certification of noncompliance leading to an
enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see 42 C.F.R. §§ 488.330(e), 498.3.
However, CMS’s choice of remedies, or the factors CMS considered when choosing
remedies, is not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only
challenge the scope and severity level of noncompliance that CMS found if a successful
challenge would affect the amount of the CMP that CMS could collect or impact upon
the facility’s NATCEP. 42 C.F.R. § 498.3(b)(14)(i), (ii). CMS’s determination as to the
level of noncompliance “must be upheld unless it is clearly erroneous.” 42 C.F.R. §
498.60(c)(2). This includes CMS’s finding of immediate jeopardy. Woodstock Care
Ctr., DAB No. 1726, at 9, 38 (2000), aff'd, 363 F.3d 583 (6th Cir. 2003). The
Departmental Appeals Board (Board) has long held that the net effect of the regulations is
that a provider has no right to challenge the scope and severity level assigned to a
noncompliance finding, except where that finding was the basis for an immediate
jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester
Pavilion, DAB No. 1750 (2000). ALJ Review of a CMP is governed by 42 C.F.R.

§ 488.438(e).

In a CMP case, CMS must make a prima facie case that the facility has failed to comply
substantially with participation requirements. To prevail, a long-term care facility must
overcome CMS’s showing by a preponderance of the evidence. Hillman Rehab. Ctr.,
DAB No. 1611 (1997), aff'd, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human
Servs., No. 98-3789, 1999 WL 34813783 (D.N.J. May 13, 1999).

IV. Findings of Fact, Conclusions of Law, and Discussion

My findings of fact and conclusions of law are set forth in bold and are followed by my
analysis.

During the February 2008 survey, Petitioner was found out of substantial compliance
with the following participation requirements: 42 C.F.R. § 483.25(h) (F Tag” 323, at a
scope and severity level (SS)* J); 42 C.F.R. § 483.35(i)(2) (F Tag 371, SS E); 42 C.F.R.

> An F Tag designation refers to the part of the State Operations Manual (SOM) that

pertains to the specific regulatory provision allegedly violated, as set out in the statement

of deficiencies (SOD).

> CMS and a state use scope and severity levels when selecting remedies. The scope

and severity level is designated by an alpha character, A through L, which CMS or the

state agency selects from the scope and severity matrix published in the SOM, section

TAOOE. See 42 C.F.R. § 488.408. A scope and severity level of A, B, or C indicates a

deficiency that presents no actual harm but has the potential for minimum harm.

Facilities with deficiencies of a level no greater than C remain in substantial compliance.
(...Continued)
§ 483.15(e)(1) (F Tag 246, SS D); 42 C.F.R. § 483.25(a)(3) (F Tag 312, SS D); 42 C.F.R.
§ 483.25(k) (F Tag 328, SS D); and 42 C.F.R. § 483.75(I)(1) (F Tag 514, SS D). CMS
Ex. 1.

In this decision, I discuss the immediate jeopardy Tag at F 323, and only the non-
immediate jeopardy Tags at F 246, F 312, and F 328. I am not required to make findings
of fact and conclusions of law on deficiencies that are not necessary to support the
remedies imposed, as is the case here where the CMPs imposed are at almost the
minimum for per-day CMPs at both the immediate and non-immediate jeopardy levels.
Batavia Nursing & Convalescent Ctr., DAB No. 1904, at 21-22 (2004); Cmty. Skilled
Nursing Ctr., DAB No. 1987 (2005); Golden Living Ctr. — Frankfort, DAB No. 2296, at
3 n.2 (2009). Thus, I do not address all five of the non-immediate jeopardy deficiencies
that the surveyors cited.

1. Petitioner was out of substantial compliance with the participation
requirement at 42 C.F.R. § 483.25(h) (F Tag 323, SS J).

Pursuant to 42 C.F.R. § 483.25, in pertinent part,

Each 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.
oR ROR
(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.
42 C.F.R. Ch. IV (10-1-07 Edition). The requirements of this regulation have been
explained in numerous Board decisions. See, e.g., Golden Age Skilled Nursing & Rehab.

(Continued...)

A scope and severity level of D, E, or F indicates a deficiency that presents no actual
harm but has the potential for more than minimal harm that does not amount to
immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that
involves actual harm that does not amount to immediate jeopardy. Scope and severity
levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or
safety. The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are
required and optional at each level based upon the frequency of the deficiency, i.e.,
whether a deficiency is isolated, part of a pattern, or widespread. 42 C.F.R. § 488.301.
Ctr., DAB No. 2026 (2006); Woodstock Care Ctr., DAB No. 1726 (2000), aff'd,
Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).

The Board has stated with regard to subsection (h)(1),

The standard in section 483.25(h)(1) itself — that a facility “ensure that the
resident environment is as free of accident hazards as possible” in order to
meet the quality of care goal in section 483.25 — places a continuum of
affirmative duties on a facility. A facility must determine whether any
condition exists in the environment that could endanger a resident’s safety.
If so, the facility must remove that condition if possible, and, when not
possible, it must take action to protect residents from the danger posed by
that condition.

Laurelwood Care Ctr., DAB No. 2229, at 8 (2009) (quoting Me. Veterans’ Home —
Scarborough, DAB No. 1975, at 5 (2005)). The Board states further that section
483.25(h)(1) clearly informs facilities that they must ensure that the resident environment
remains as free of accident hazards as possible. The Board cites 42 C.F.R. § 483.20(b) in
noting that other program requirements in the regulations require nursing home facilities
to engage in a comprehensive assessment of a resident’s needs.

Although section 483.25(h) does not make a facility strictly liable for accidents that
occur, it does, under subsection (h)(2), require the facility to 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. Woodstock Care
Ctr. v. Thompson, 363 F.3d at 590 (holding a skilled nursing facility must take “all
reasonable precautions against residents’ accidents”). Facilities have the “flexibility to
choose the methods of supervision” to prevent accidents so long as the methods chosen
constitute an adequate level of supervision under all circumstances. Golden Age, DAB
No. 2026, at 11 (citing Woodstock, 363 F.3d at 590).

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 Ctr., DAB No. 2053, at 8-9 (2006), aff'd, Woodland Village
Nursing Ctr. v. U.S. Dep’t of Health & Human Servs., 239 Fed. App’x 80
(5th Cir. 2007), citing Spring Meadows Health Care Center, [DAB No.
1966,] at 16-18 [(2005)] (addressing facility failures to observe their own
policies for resident care). Failure to fully employ those measures as
intended may thus be . . . evidence that the facility failed to provide
residents with needed care and supervision as required by the regulation.
Cedar Lake Nursing Home, DAB No. 2288, at 6-7 (2009).

The February 7, 2008 statement of deficiencies reflects that Petitioner:
[F]ailed to assess, identify, develop and implement a plan of care, and
failed to monitor to prevent one (1) of six (6) sampled residents, with
wandering behaviors, from exiting the building unsupervised. On two
occasions Resident # 6 propelled her wheelchair through the two sets of
double doors at the front/main entrance and exited the facility unnoticed
and unsupervised. *

CMS Ex. 1, at 9.
Resident 6

Resident 6 (R6) was first admitted to the facility on September 17, 1998, at the age of 64.
P. Ex. 1, at 1; CMS Ex. 9, at 13. R6’s admitting diagnosis included: subdural hematoma
with memory loss and fall; seizures; depression; hypertension; emphysema; panic
disorder; and accidental benzodiazepine overdose. P. Ex. 1, at 1. R6’s updated diagnosis
through the end of 2001 included: paranoid ideation; transient ischemic attack; dementia;
ypothyroidism; and pneumonia. /d. In December of 2003, R6 was readmitted after
ospitalization with an admitting diagnosis that included, inter alia: major depression
with severe psychosis; mild dementia; abnormal EEG; seizure disorder; vitamin B-12
deficiency; and hypertension. Jd. at 2.

According to R6’s plan of care, during the period from April 2006 to January 2008, R6:
ad potential for drug related side effects from the use of psychotropic medication; was at
risk for bleeding due to use of anti-coagulation therapy; had potential for falls due to
istory of seizures, CVA with left hemiparesis, dementia, psychosis, and psychotropic
medications usage; was unable to complete ADL tasks independently related to
emphysema, COPD, history of CVA with left hemiparesis, depression with psychosis,
seizures, and dementia; had cognitive loss due to dementia; had impaired respiratory
status; and history of seizures was noted. Jd. At 10-19. From January 2007 to January
2008, R6 also had pain “c/o leg pain tingeling [sic].” /d. at 21. And from September
2007 to January 2008, R6 had mood and behaviors requiring Depakote for paranoid
behaviors and Klonopin for diagnosis of anxiety, psychotic disorder. Jd., at 22.

4+ Petitioner argues that “[iJn the SOD, CMS did not differentiate between its grounds

for asserting noncompliance with subsection (1) and subsection (2) of § 483.25(h),”
which is ‘a material due process violation because it deprives the provider of adequate
notice, forcing it to guess the basis for the government’s conclusions under each
subsection.” P. Br. at 14. I find no merit to this argument. The SOD clearly state both
the failure to provide an environment free of hazards under subsection (1), and the failure
to provide adequate supervision to mitigate foreseeable risks of harm under subsection

(2).
10

The Facility

Asheville is a 106-bed facility. Tr. at 668. It is located in a rural area, east of Asheville.
Id. The facility is located off a five-lane highway. P. Ex. 3, at 22. The front entrance to
the facility has two sets of glass doors, which can only be opened manually using a push
bar. Tr. at 95, 676; P. Ex. 3, at 2. In between the two sets of doors is a little breezeway.
Tr. at 95. Outside the doors is an overhang with a drive directly in front of the door, and
to the left is a parking lot. Tr. at 95; P. Ex. 3, at 5. Three parking spaces line the
sidewalk along the front of the facility, two of which are marked for handicap use. P. Ex.
3, at 19. Beyond the three parking spaces is a grassy area and then the rest of the parking
lot. Tr. at 96. To the left of the three parking spaces, at an angle in front of them, is the
entrance into the facility from the highway. Jd.

The facility is not a locked facility in that two of the doors, the main entrance to the
facility and a back door that is used as an employee entrance, remain unlocked with no
alarm during the day from 7:00 AM to 11:00 PM, seven days a week. Tr. at 636, 677,
775. All other doors to the facility are locked and alarmed. Tr. at 710-13. The facility
employs a receptionist at a desk in the front of the facility from 10:30 AM to 7:00 PM,
Monday through Friday, but not on weekends. Tr. at 383, 720, 722, 774.

The facility screens patients and only admits those who would be safe in such an
environment. Tr. at 639, 678. In the event a resident’s condition changes and is no
longer safe in such an environment, the facility transfers the resident to a more
appropriate facility. Tr. at 678-79.

The Elopements

On October 19, 2007, a Friday, the first elopement occurred. Tr. at 476. The receptionist
on duty that day was the first to spot R6 outside, and he returned her to the facility.> Tr.
at 730. The receptionist did not testify at the hearing. No one is certain how long R6 was
outside before the receptionist saw her, or how R6 got through the front doors. Tr. at
780-81, 785-86. A nurse’s note reporting R6’s elopement was entered at 3:11 PM. Tr. at
786; CMS Ex. 9, at 96. The prior nurse’s note for that day was entered at 2:28 PM,
noting R6’s increased confusion. It also noted how R6 had grabbed the nurse who was
distributing medications, as well as a resident who was being propelled in a wheelchair
by another resident. CMS Ex. 9, at 96. At the time of the survey, the surveyors never
received clarification from the staff as to where R6 was found outside of the facility. Tr.
at 256. Based on interviews, the surveyors believed R6 was found on the sidewalk
outside the front door of the facility. Jd. Testimony during the hearing, and a diagram of

> Until conducting an investigation in preparation for this hearing, the facility believed

that a CNA found R6. Tr. at 730. After interviewing every CNA, none of whom had
found R6, it was determined that the receptionist was the first to find R6. Id.
11

the facility grounds that was submitted to the IDR panel, indicate that R6 was found in
the parking lot in one of the parking spaces just off the sidewalk aligning the front of the
building.° Tr. at 507; CMS Ex. 4, at 57. However, at the hearing, Petitioner pointed to a
progress note for R6 summarizing the elopement, which reads that R6 was found “outside
front door in [wheelchair] on sidewalk [without] supervision.” Tr. at 505; CMS Ex. 9, at
96.

On November 24, 2007, a Saturday, the second elopement occurred. The testimony of
both the surveyors and staff indicate that no incident report was filled out. Tr. at 78-79,
458-60, 694. It was never established how long R6 was outside the facility, and, because
it was a weekend, the receptionist was not there. Tr. at 79, 92-93, 453, 785. Nobody saw
or knew how R6 exited the building that day. Tr. at 450, 785. Ronnie Allen, the
Environmental Service Director who supervises housekeeping and laundry, testified that
e had just clocked out of work and was driving from the back of the building, where he
was parked, to the exit at the front of the building, when he saw R6 sitting in the third
parking space, furthest away from the front door with her cordless telephone. Tr. at 409,
414-16. Mr. Allen got out of his car to talk to R6 and tried to get her to return to the
acility. Tr. at 415-16. At that time, Todd Brown, who was reporting to work, entered
the parking lot, and he told Mr. Allen that he would go inside to get help. Tr. at 416.
Within a few minutes, a nurse’ who saw Mr. Allen and R6 through the front window,
came out and returned R6 inside the facility. Tr. at 416. Mr. Allen believes he was
outside with R6 a total of 6-7 minutes, at most. Tr. at 417. The nurse’s progress note
summarizing this elopement reads:

Resident found outside (out front) by family member visiting. Res[ident]
stated, “I know whats going on and I’m going across the street to use the
phone.” Brought resident in immediately and nurse notified the POA
[power of attorney]. Resident very anxious carrying her telephone in the
[wheelchair]. Medicated [with] prn Ativan for the anxiety. Will monitor
closely for inappropriate behaviors. Supervisor and D.O.N. notified of the
situation.

° The administrator testified that the map is mismarked due to her mistake. She

explained that she delegated the duty of making the map and did not verify it
appropriately before submitting it to the IDR panel. Tr. at 733-34. At the hearing, she
testified that she is now certain R6 was found directly outside the front doors of the
facility. Tr. at 734.

7 Conflicting testimony exists as to which nurse retrieved R6. Mr. Allen testified that
Frankie Beaver retrieved R6. Tr. at 417. Ms. Dixon, R6’s nurse, testified that she
retrieved R6. Tr. at 441. According to Petitioner’s brief, they both retrieved R6. P. Br.
at 10.
12

CMS Ex. 9, at 94. The nurse’s note immediately preceding this one indicates R6 was
exhibiting signs of paranoia and was very concerned that her medications were going to
kill her. Jd. The day before, R6 had fallen out of bed, and she was still being monitored
for latent injuries at the time of the elopement. Jd.

No documentation exists that R6 signed herself out of the facility before exiting the
facility on either occasion. Tr. at 267.

CMS’s summarized its arguments as follows:

On October 19, 2007, R6 exited Asheville Health Care Center unnoticed
and unsupervised for an unknown period of time and was found outside in
the front parking lot of the facility. Asheville did not take any corrective
measures to prevent further elopement. On November 27, 2007, R6 exited
to the front parking lot again, and was found by a visitor as R6 was
propelling her wheelchair toward a five lane highway running in front of
the facility.’ Again, Asheville did not take any corrective measures until
the time of the February 2008 survey. R6 had myriads of mental and
physical health problems such as dementia of Alzheimer’s type,
allucination, paranoia, confusion, anxiety, seizure disorder, neuropathy,
restless leg syndrom[e], tremor, congestive heart failure[], COPD,
polypharmacy, and history of falls. Asheville failed to provide an
environment that is free of accident hazards over which it had control,
because two of its exit doors had no alarms and no supervision to prevent
unauthorized access. Asheville also failed to provide adequate supervision
and assistance devices to prevent R6 from eloping and being exposed to the
ikelihood of suffering serious harm. As such, Asheville failed to be in
substantial compliance with 42 C.F.R. § 483.25(h).

CMS Br. at 1.

There are no nurse’s or doctor’s notes or other indications before October 19, 2007, the
date of R6’s first elopement from the facility, that R6 was an elopement risk. At that
time, R6 had been a resident at the facility for nine years. As indicated by CMS’s
decision to impose a CMP effective November 24, 2007, as opposed to October 19, 2007,
the effective date recommended by the State Agency, it is reasonable to conclude that it is
undisputed that it was not foreseeable that R6 was an elopement risk prior to October 19,
2007.

® Whether R6 was propelling her wheelchair toward the highway or sitting stationary is in
dispute. P. Br. at 15.
13

Petitioner argues that R6’s second elopement from the facility was also unforeseeable. P.
Br. at 1 (“Neither exit was reasonably foreseeable.”); P. Reply Br. at 3 (“Both exits were
isolated occurrences.”). On October 19, 2007, however, the facility was now on notice
that R6 was able to elope from Petitioner’s facility undetected. That knowledge placed
Petitioner on notice and obligated Petitioner to take steps necessary to adequately
supervise R6 to prevent further elopements. Liberty Commons Nursing & Rehab Ctr. —
Alamance vy. Leavitt, 285 F. App’x 37, 42 (2008).

Petitioner argues that it was in substantial compliance with 42 C.F.R. § 483.25(h),
because CMS did not make a prima facie case of noncompliance. P. Br. at 13-15.
Specifically, Petitioner argues: (1) there was no accident; (2) there was not an
elopement; (3) the absence of particular documentation expressly referencing exit-
seeking behavior does not demonstrate the facility did not intervene to prevent it, and
thus does not demonstrate noncompliance; and (4) CMS’s conclusions are not entitled to
deference. P. Br. at 15-22. I will discuss each of Petitioner’s four arguments in turn
below.

First, Petitioner argues that R6’s exits were the direct result of her medication, and thus
they are not properly considered an “accident” for purposes of determining compliance
with section 483.25(h). P. Br. at 16-17. Petitioner relies on Transmittal 27, which states
that an “accident” for purposes of section 483.25(h) “does not include adverse outcomes
that are a direct consequence of treatment or care that is provided in accordance with
current standards of practice (e.g., drug side effects or reaction).” P. Br. at 16.
Moreover, Petitioner argues that R6’s exiting behavior was a consequence of R6’s
medication or a possible urinary tract infection, which caused anxiety and confusion. Id.
Cynthia Brantley, the geriatric nurse practitioner who worked closely with R6’s doctor,
testified that ordering a urinalysis the day of the October exit was the intervention for the
elopement. Tr. at 513.

This argument misses the point that, regardless of what other care R6 needed at this time,
the facility also needed to take reasonable steps necessary to prevent future undetected
elopements that put R6 at risk of harm and accidents. An elopement is not an “adverse
outcome” of the treatment of care; rather, the increased confusion and paranoia was
thought to be the adverse outcome from R6’s medications. Tr. at 477-78 (testimony of
Cynthia Brantley, geriatric nurse practitioner, on whether the increased confusion and
paranoia was due to R6’s drugs or to a urinary tract infection); Tr. at 624 (testimony of
Dr. Holl stating that changes in anxiety medication instigated the November elopement
by making R6 more anxious with increased energy). Upon review of R6’s plan of care,
these symptoms of confusion and paranoia do not appear to be new to R6 such that
elopement could be determined to be the direct consequence of these side effects or
reactions. P. Ex. 1, at 16 (noting increased confusion and paranoia on April 8, 2007); P.
Ex. 1, at 1 (listing admitting diagnoses and updated diagnoses through 2001, which
include seizures, depression, panic disorder, paranoid ideation, and dementia); CMS Ex.
4, at 15 (noting diagnosis of Alzheimer’s dementia with mild short and long term
14

memory deficits on August 2, 2006). There is no allegation that the facility did not take
proper steps to treat R6’s confusion and paranoia. The allegation is that the facility did
not perform its affirmative duty to protect R6 from the danger that undetected elopements
posed.

Second, Petitioner argues that there was not an elopement. P. Br. at 17. Petitioner relies
on a definition of elopement that extends the definition of “premises” to include the
facility grounds.’ P. Br. at 17; P. Ex. 10 (SOM, app. PP, defining elopement). The
Petitioner argues that, because R6 never left the grounds of the facility and never left a
safe area, no elopement occurred. Id.

Petitioner also argues that the “mere fact that [R6] was outside did not make her unsafe or
put her at risk.” Jd. Petitioner relies on the fact that R6 was “only [outside] for a few
minutes” and the fact that no harm occurred. /d. at 17-18. Petitioner maintains that
CMS’s focus is grounded solely in strict liability, since CMS argues that a violation of
section 483.25(h) occurred when the resident exited the facility. Jd. at 19.

Those arguments also miss the point in that the issue here is that the resident, who is
cognitively impaired and not capable of protecting herself, left the facility undetected,
without nursing staff supervision. The purpose of the regulation is to keep residents safe,
regardless of whether the resident leaves the facility grounds or simply wanders into an
unsafe area, such as a kitchen, undetected and unsupervised. An elopement in and of
itself is not the reason Petitioner was found out of compliance with section 483.25(h);
rather, it was the fact that Petitioner did not plan or implement adequate interventions to
address the elopement, and, as a consequence, R6 was not well-supervised and was at
risk of accident. Compare Pinehurst Healthcare & Rehab. Ctr., DAB No. 2246, at 25
(2009) (Petitioner was out of compliance with 42 C.F.R. § 483.25(h) because it failed to
establish that its monitoring of elopement-prone residents was adequate) with Willow
Creek Nursing Ctr., DAB. No. 2040 (2006) (Facility was in compliance with 42 C.F.R.
§ 483.25(h) despite R4’s elopement, because it planned and implemented effective
interventions to address the elopement risk, and R4 was found to be well supervised.).
Here, Petitioner failed to establish that its monitoring of R6 was adequate, as further
addressed in the discussion of Petitioner’s third argument below.

Petitioner’s third argument is that the absence of particular documentation expressly
referencing exit-seeking behavior does not mean that the facility did not intervene to
prevent it and, thus, does not demonstrate noncompliance. P. Br. at 19.

° “Elopement,” as defined in the SOM, “occurs when a resident leaves the premises or a
safe area without authorization (i.e., an order for discharge or leave of absence) and/or
any necessary supervision to do so.” SOM, app. PP.
15

The problem with this argument is that Petitioner has presented no credible evidence that
the facility intervened to address R6’s elopement risk such that adequate supervision of
R6 was provided. The facility did take the step of attempting to transfer R6 to another
facility. P. Ex. 1, at 253, 306; CMS Ex. 9, at 38. However, no beds were available at
either of the two facilities to which a transfer was attempted. P. Ex. 1, at 306; CMS Ex.
9, at 38. No further attempts to transfer R6 were made, and no documentation exists
beyond that of any plans or interventions to address R6’s elopement risk, even though
R6’s elopement risk is in the doctor notes dated November 30, 2007. Jd. That inaction
was despite the fact that those same doctor notes indicate that R6 has “[a]ctive range of
motion all extremities. She is propelling her wheelchair in the hallway today.” Jd. Dr.
Holl testified that he did not believe R6 was an exit seeker, because he did not believe R6
had the strength to push the front doors to exit the facility. As such, he did not perform
an elopement evaluation for R6 after the October exit. Tr. at 606, 636-38, 662. Dr. Holl
later clarified that he did believe R6 to be an elopement risk after the second exit, and he
attempted to transfer R6 to another facility. Tr. at 639-40. As noted above, however, that
attempt failed. Petitioner has not come forward with any evidence sufficient to
demonstrate that it planned or implemented effective interventions to address R6’s
elopement risk prior to February 6, 2008.

As stated in Liberty Commons, the two factors used to determine whether Petitioner’s
response was reasonable are whether: a risk of an “accident” was foreseeable; and the
facility’s response was adequate under the circumstances. Liberty Commons, 285 F.
App’x at 44 (citing Woodstock Care Ctr., DAB No. 1726). As noted above, the second
elopement on November 24, 2007 was foreseeable, because Petitioner was put on notice
of R6’s elopement risk after the first elopement on October 19, 2007. Petitioner’s
response to R6’s behavior was not adequate. Petitioner’s attempt to transfer R6 to
another facility failed. Petitioner has not demonstrated any further action it took to
specifically address R6’s elopement risk.

Petitioner maintains that “[t]he record is clear that between October 19 and the November
24 exit, the facility placed the resident on acute monitoring for increased paranoia and
wandering, wrote progress notes reporting on the resident, evaluated the resident’s
behavior and documented multiple interactions with the residents’ physicians.” P. Br. at
26.

Progress notes on the resident, evaluation of the resident’s behavior, and documentation
of interactions with the resident’s physicians are all steps that would be performed
regardless of whether the patient was an elopement risk. In other words, these are not
additional steps that the facility took to ensure the resident was properly monitored for
her wandering and exit seeking behavior. See Tr. at 688, 769-72. There is no evidence
that these tasks occurred more frequently or in a heightened manner to consider R6’s
elopement risk.
16

In regard to the acute monitoring for increased paranoia and wandering, the acute
monitoring charts'° were not presented to the surveyors at the time of the February
survey. Tr. at 177. Upon review of the documentation presented during the survey, no
documents indicate the monitoring of R6’s whereabouts and safety in terms of exit
seeking behavior and wandering. Tr. at 194. During the relevant time, there is only
documentation of monitoring for adverse reactions to medications, particularly the
antibiotics for a urinary tract infection. Id.

The acute monitoring charts were found after the survey. Only the first two of the six
pages of P. Ex. 4, which set forth the acute monitoring charts, indicate a frequency of
“acutely” monitor!’ for, inter alia, “paranoia, wandering behavior.” Jd. at 1-2. The next
two pages are for the monitoring of “VS latent injury, (L) shoulder bruising c/o pain” at a
frequency of “Q [(every)] shift x 3 days.” Jd. at 3-4. The last two pages are for the
monitoring of “Neg. statements, effectiveness” at a frequency of “Q shift x 14 days.” Id.
at 5-6.

The acute monitoring charts list “paranoia, wandering behavior” under the “points to
chart” heading; however, “paranoia, wandering behavior” is handwritten on the chart,
whereas “refusing meds, anxiety,” which is also listed in that same section of the chart, is
typed as with most other entries on the relevant pages. P. Ex. 4, at 1-2; Tr. at 702-05. At
hearing, Petitioner submitted a replacement copy of this exhibit, because three of the
pages were not originally submitted. Tr. at 12. CMS objected to the admission of the
additional three pages stating that, although the documents are very relevant in that they
go to the monitoring of the resident who had eloped during the relevant time period, the
charts were not provided to the surveyor at the time of the survey, and they were not
submitted to the state office during the time of IDR. Tr. at 14, 699. In addition, CMS
questioned the authenticity of the documents. Tr. at 14. CMS points out that these charts
present a lot of inconsistencies, such as: Petitioner indicating that six pages were faxed to
the facility’s attorney, when the fax information at the top of the page indicates only five
pages were faxed; and the Petitioner’s pre-hearing brief states that acute monitoring

' The staff indicated that the acute monitoring charts are used as an internal

communication tool at the facility. Tr. at 802. The nurses refer to these charts, which are
located at the nurses’ stations, to learn what they should look for with the residents. Id.
The nurses then document the behaviors they are to look for in their progress notes. If
that specific behavior does not occur, the nurse does not have to write anything in the
progress report. Tr. at 769; 772.

"According to the testimony of Jill Dixon, a L.P.N. at the facility, “acutely” under the

“frequency” category of the acute monitoring charts means whenever that patient for
whom the entry is written exhibits the behavior indicated, such as paranoia, wandering
behavior, then the nurse is to document that in the nurse’s notes. Tr. at 456-57.
17

started on October 20, 2007 and stopped after three days, but, on the substituted exhibit, a
page dated October 30, 2007, which is more than three days after when the acute
monitoring was alleged to have begun, it states that acute monitoring is still occurring.
Tr. at 15, 704-05 (noting that unit managers update acute monitoring charts on a daily
basis, or every couple of days).

The direction to monitor R6 for paranoia, wandering behavior is handwritten even on the
acute monitoring chart dated October 30, 2007, ten days after the instruction was given.
Petitioner had plenty of time to update the chart in the computer system so that the
monitoring directions would also be computer generated. I am concerned that the records
were not provided to the surveyors, or as part of the exchange process, in these
proceedings prior to trial. Furthermore, no corroboration exists in the nurse’s notes of
any monitoring for paranoia, wandering behavior. The facility states that no
documentation means that no wandering behavior is observed, because the nurses do not
have to note anything that did not occur. Tr. at 707, 806-07. Because there is no notation
regarding wandering behavior during the time period in which acute monitoring took
place, there is no way of knowing if in fact the nurses performed such monitoring, and
there is no evidence illustrating how this monitoring was actually performed to ensure
R6’s safety.”

Instead, the testimony and Petitioner’s brief, which argues no elopement occurred,
indicates that staff did not even find R6 to be an elopement risk, much less indicate that
they had concern for preventing such behavior. Tr. at 497, 509, 623; P. Br. at 17-19, 23.
The director of nursing (DON) at the time of the elopements and the administrator
indicated to surveyors that they were not even aware of R6’s elopements until their
interviews with surveyors.'? Tr. at 393, 809.

The current DON testified that there are no procedures at the nursing home, or under the
parent company, to follow when a resident has left the facility. She indicated that they
have a policy on a missing resident, but the DON testified that R6 was never missing. Tr.
at 811. None of the systems described to be in place to ensure that communication

The only corroboration that was indicated was oral communication among the nurses

between shifts. Tr. at 448; 688-90.
‘3 Contradictory evidence exists that the DON and administrator knew of the elopement.
The Resident Council minutes indicate that council members told the administrator about
their concern for residents leaving the facility undetected. The nurse’s progress notes
indicate the DON was notified. CMS Ex. 24, at 34; Tr. at 460; CMS Ex. 9, at 94. In
addition, the administrator testified that Asheville ordered a Wanderguard system (an
electronic monitoring system) the last week of December, had it installed in January, but
it was not yet operational at the February survey because of a computer chip defect. T. at
723.
18

occurs to prevent accidents indicate R6’s safety was adequately monitored to prevent
undetected exiting from the facility. See Tr. at 688 (listing the following systems to
facilitate communication to prevent accidents: lots of oral communication during shift
changes; handwritten shift reports by nurses; progress notes that can be flagged to attach
to a resident’s medical record; and acute monitoring sheets).

Petitioner argues that “[t]here is no requirement that a resident be within eye view at all
times.” P. Br. at 26. Although this is true, two doors of the facility were not locked, or
alarmed, and were not monitored at all times. There was systematic failure to supervise
or alarm the doors. Petitioner lists as systematic measures and safeguards to ensure
safety the following: its closed unit staffing model; and the structural elements of the
facility and premises, such as the large windows on the front of the facility and the design
of the parking lot and doors. P. Reply Br. at 2. Petitioner also points to the fact that it
had ordered and installed an electronic monitoring system and hired a staff person to
monitor the front door on weekends. P. Reply Br. at 4. But, the electronic monitoring
system was not operational at the time of the survey, and there were still times when the
front door was unlocked and not monitored. T. at 94, 723.

To provide adequate supervision of R6 under these circumstances, a plan for monitoring
R6 or for some type of successful and effective intervention is required. While a facility
has discretion to determine the specific manner by which to achieve adequate
supervision, it must implement some form of supervision to meet the regulatory
requirement of adequate supervision. Petitioner points to no reason why I should assume
that its level of supervision provided to R6 increased after her elopement. Petitioner has
not identified any such measures that were in fact adopted to specifically address R6’s
elopement risk. Instead, Petitioner lost an opportunity to analyze and correct the problem
that led to the elopement by failing to have an effective system for staff to even report
and investigate such episodes.'* This is illustrated in Petitioner’s presentation of
different events at hearing than were presented to the state, as well as Petitioner’s
presentation of new evidence, the acute monitoring charts, in the course of litigation.

Petitioner’s fourth argument is that CMS is not entitled to deference. P. Br. at 20-22.
However, CMS has presented a prima facie case that Petitioner is out of compliance with
42 C.F.R. § 483.25(h). As stated above, Petitioner was on notice that R6 was an

‘4 No incident report was given to the surveyors or produced as evidence at the hearing.

The testimony regarding whether one was filled out was ambiguous. Tr. at 457-59.
However, Ms. Dixon, R6’s nurse, concluded in her testimony that she does not recall if
one was filled out but that she would have recalled this fact at the time of the survey in
February 2008. Tr. at 458-60. The administrator also indicated that no incident report
was filled out for the elopements. Tr. at 694.
19

elopement risk after successfully exiting the facility undetected, and the facility’s
response was insufficient to ensure R6’s safety. It is now Petitioner’s burden to prove
beyond a preponderance of the evidence that it was in substantial compliance. Hillman
Rehab. Ctr., DAB No. For the reasons set forth above, Petitioner has not met this burden.

2. Petitioner was out of compliance with the participation requirement at 42
C.F.R. § 483.15(e)(1) (F Tag 246, SS D).

Pursuant to 42 C.F.R. § 483.15, which reads, in pertinent part:

A facility must care for its residents in a manner and in an environment that
promotes maintenance or enhancement of each resident's quality of life.

oR RK

(e) Accommodation of needs. A resident has the right to—

(1) Reside and receive services in the facility with reasonable
accommodation of individual needs and preferences, except when the
health or safety of the individual or other residents would be endangered;

The February 7, 2008 SOD reflects that Petitioner:

[F]ailed to ensure a call bell was within reach for one (1) of twenty (20)
sampled residents who use a call bell to request assistance. (Resident #7)

CMS Ex. 1, at 1. Petitioner’s care plan for resident 7 (R7) reads, “[c]all bell within
reach.” CMS Ex. 11, at 19. That intervention is listed to address R7’s history of
falls, dizziness, psychotropic medications, and bilateral knee osteoarthritis. Id.

Petitioner argues CMS presented insufficient evidence to establish that the facility failed
to provide a resident with reasonable accommodations. P. Br. at 34. Specifically,
Petitioner argues that R7 could always access assistance: “(i) when she was in bed, she
could access a call bell that allowed her to call staff for assistance; and (ii) when the
resident was in her wheelchair, she could maneuver her chair to the hallway and ask for
assistance.” Id.

The surveyor testified:

I had observations on each day of the survey when the Resident was out of
bed, in her wheelchair that the call bell was not within her reach. It was
attached to the top side rail of her bed. She was in bed B, which is the bed
closest to the window. And the call bell was wrapped around the left side
rail which would have put it on the side rail that is closest to the other bed.
20

And there was not enough room for her to move her wheelchair to reach the
call bell.
OK Kk

[W]hat my assessment was and what the [survey] team talked about is the
fact that [R7] had a history of falls and that she did have some injury from
that -- from at least one of those falls. And that the facility had assessed and
care planned for her to have a call bell within reach. And I had consistent
observations throughout the survey of when she was in her wheelchair the
call bell was not within her reach. So because she had a history of falls if
she attempted to get that call bell when it was not in reach, there’s a
potential for her to have another fall. And therefore, other . . . injury. So
there’s potential for more than minimal harm, the D level that we placed the
deficiency at.

T. at 338, 346-47. During the surveyor’s interview with the resident, R7 stated that she
could not reach the call bell, unless she gets up and walks to get it. T. at 341; CMS Ex. 1,
at 3. I find the surveyors observations and interview findings are sufficient evidence to
constitute a deficiency under the applicable regulation. R7 was care planned to have a
call bell within reach, and it was not.

3. Petitioner was out of compliance with the participation requirements at 42
C.F.R. §§ 483.25(a)(3) (F Tag 312, SS D) and 483.25(k) (F Tag 328, SS D).

Pursuant to 42 C.F.R. § 483.25(a)(3), (k),

(a) Activities of daily living. Based on the comprehensive assessment of a
resident, the facility must ensure that—

oR ROR
(3) A resident who is unable to carry out activities of daily living receives
the necessary services to maintain good nutrition, grooming, and personal
and oral hygiene.

oR ROR
(k) Special needs. The facility must ensure that residents receive proper
treatment and care for the following special services:

oR ROR

(7) Foot care
The February 7, 2008 SOD reflects that Petitioner:

[F]ailed to provide toe nail care to three (3) of twenty (20) sampled
residents in need of extensive assistance with personal hygiene. (Resident
#14, 15, & 19)

oR RK
21

[F]ailed to provide toe nail care to two (2) of two (2) sampled diabetic
residents who required nail and foot care by a podiatrist. (Resident # 7 and
#22)

CMS Ex. 1, at 3, 29.

Petitioner has not adduced evidence or presented argument to rebut the allegations.
Petitioner’s only argument with regard to these deficiencies is that “Surveyor Robinson
admitted that at least one resident, Resident 19, suffered no actual harm from any alleged
deficiencies.” P. Br. at 35. Regardless of whether actual harm occurred, the regulation
requires that the facility ensure the residents receive proper treatment and care. Petitioner
neglected to provide this care for five residents. The allegations in the SOD in this case
are sufficient to establish a prima facie case, unless disproved or rebutted. Accordingly, I
sustain these deficiencies.

4. Petitioner’s noncompliance with the participation requirement at 42 C.F.R.
§ 483.25(h) (F Tag 323, SS J) constituted immediate jeopardy to its residents.

The regulations define “immediate jeopardy” as “‘a situation in which the provider’s
noncompliance with one or more requirements of participation has caused, or is likely to
cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.
CMS’s determination about the level of noncompliance must be upheld, unless it is
clearly erroneous. 42 C.F.R. § 498.60(c).

The surveyors concluded:

Immediate Jeopardy began on 10/19/07 when Resident # 6 exited the
building unsupervised and was removed 2/7/08 at 11:45 AM. The facility
remained out of compliance at a lower scope/severity of (D), isolated with
potential for more that [sic] minimum harm while monitoring the
implementation of their corrective actions stated on the credible allegation.

CMS Ex. 1, at 9. As noted above, CMS instead determined that an immediate jeopardy
situation existed on November 24, 2007 through February 7, 2008, as a result of
Petitioner’s noncompliance with section 483.25(h) (Tag F 323). CMS Ex. 2, at 2.
Petitioner argues that immediate jeopardy is reserved for “crisis situations in which the
health and safety of individuals are at risk,” relying on the language in the State
Operations Manual (SOM), Appendix Q, Guidelines for Determining Immediate
Jeopardy (Rev. 1, May 21, 2004). P. Br. at 28.

The SOM also lists immediate jeopardy triggers, which are situations that most likely
create jeopardy to an individual’s psychological and/or physical health and safety, and
describe situations that will cause the surveyor to consider if further investigation is
needed to determine the presence of immediate jeopardy. SOM, app. Q, at 4. The
22

following is listed as a trigger, “[l]ack of supervision of cognitively impaired individuals
with known elopement risk.” Jd. at 5. Upon observing or identifying a trigger, the
surveyors are instructed to investigate the situation further to determine whether
immediate jeopardy is present, which is a very fact-specific analysis. SOM, app. Q.

In this case, the surveyors determined that R6’s ability to elope undetected resulting in
unsupervised exposure to areas beyond the confines of the facility walls constituted
immediate jeopardy. CMS agreed with the surveyors’ finding, as do I. R6 is of advanced
age, has a history of falls and seizures, is being care-planned for confusion and dementia,
which includes paranoia and delusions, and is on psychotropic medication with noted
interventions for side affects that include behavior problems requiring a psych consult. P.
Ex. 1, at 10-19. Thus the finding of immediate jeopardy is not clearly erroneous, because
patients suffering from conditions similar to R6’s have wandered from their facility and
been involved in accidents. Liberty Commons, 285 Fed. App’x at 43 (including cases
cited therein). In this case, the crisis situation is R6’s undetected elopement outside of
the facility walls for an unknown period of time during which she was unsupervised and
at risk of accident.

Petitioner argues that “the fact that the resident was quickly seen [and] brought back
inside each time was evidence that the facility systems, including its emphasis on staff
training, worked.” P. Br. at 28. Petitioner further argues that there was not a “risk of
[R6] being hit by a car or anything like that in the parking lot” and focuses on the fact
that R6 was not injured. P. Br. at 28-29.

According to the plain language of the regulation, a finding of immediate jeopardy only
requires that a nursing facility’s noncompliance is likely to cause harm to a resident. 42
C.F.R. § 488.301 (emphasis added). The purpose of the regulation, 42 C.F.R. §
483.25(h)(2), is to prevent not only actual harm, but also likely harm to a resident.
Liberty Commons, 258 Fed. App’x at 44 (citing Woodstock, 363 F.3d at 589). Thus, it is
irrelevant that R6 was not injured. Here, R6 exited the facility undetected on two
occasions, and the staff was uncertain as to how long R6 had been outside the facility.
Tr. at 453. The fact that R6 eloped on more than one occasion increased the possibility
that she would suffer an injury, especially given her medical condition.

Petitioner’s assertion that R6 was quickly seen and brought back inside is speculative.
As noted above, the staff was unsure how long R6 had been outside the facility. Further,
it is not evidence that the facility had an effective system in place to prevent elopements,
but instead merely a fortuitous sequence of events. No one at Asheville claimed to have
been aware of R6’s absence or to have been looking for her before the receptionist
luckily spotted R6 outside the front door after the first elopement, or an off-duty staff
member luckily spotted R6 in the parking lot as he was leaving work after the second

23

elopement.'> R6’s recovery from outside, if prompt (which, is hard to prove, because no
one knows the point at which R6 left the facility), was merely fortuitous and lends no
confidence that eloping residents would generally be promptly rescued.

The likelihood of serious harm is weighed not merely by the fortuitous sequence of
events that actually resulted from lack of supervision in the instances discovered by the
surveyor, but by considering what the episode reveals about dangers to which residents in
the facility were exposed by the identified problems and how likely such dangers were to
result in serious harm. The fact that a resident, who was care planned for maintaining a
safe environment (CMS Ex. 9, at 70) and who had a history of seizures, falls, and
dementia, could wander off entirely unnoticed and not be sought until off-duty staff
members spotted her, presents significant likelihood that vulnerable residents might
encounter the dangers involved with wandering away, such as falls, traffic, and so forth.'°
See P. Ex. 2, at 10-19.

Petitioner maintains that “[b]alanced against the resident’s need for protection is the right
to be maintained in the least restrictive manner.” P. Br. at 29. Petitioner provides no
authority to support a conclusion that safeguarding a resident’s dignity or independence is
preferred to protecting a resident from accidents. Accordingly, I find no merit in
Petitioner’s position.

Petitioner argues that the resident’s family requested that R6 be permitted to stay at
Asheville and that it is reasonable to conclude that the resident’s family would have
moved her to another facility “had they believed that continued stay at Asheville posed a
danger.” P. Br. at 30. The facility is not simply absolved of responsibility for providing
the care needed by the family’s wishes. Koester Pavilion, DAB No. 1750, at 34.

5. The remedies imposed are reasonable.

a. The imposed CMP of $3,550 per day from November 24, 2007 through
February 6, 2008 is reasonable.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. §
488.438(f) must be considered: (1) the facility’s history of noncompliance, including
repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the

'S The parties are not in agreement as to who in fact spotted R6 in the parking lot first

after the second elopement. See P. Br. at 10 n.9.

‘6 Although Asheville screens residents before admitting them to ensure they are not
elopement risks, residents do change over time, as occurred with R6. Upon assessment
of all residents, Asheville identified other elopement-risk residents. Tr. at 736-37.
24

deficiencies as set forth at 42 C.F.R. § 488.404; and (4) the facility’s degree of
culpability.

The upper range of CMP, from $3,050 per day to $10,000 per day, is reserved for
deficiencies that constitute 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).

CMS seeks to impose an upper-range CMP of $3,550 per day from November 24, 2007
through February 6, 2008, for a total upper-range CMP of $262,700.

With respect to the facility history, CMS asserts that Petitioner was repeatedly out of
compliance with Tag F 323, a total of six times since 2003, one of which was an
immediate jeopardy level deficiency cited at the January 18, 2007 complaint survey.
CMS Br. at 29.

Petitioner explains that the other Tag F 323 citations had nothing to do with elopement.
P. Br. at 31. The immediate jeopardy citation that occurred in 2007 was related to a
motor vehicle accident. /d.; P. Ex. 35. Two citations in 2004 and 2005 were related to
the hot water heater and water being too hot. Jd.

With respect to the facility’s financial condition, Petitioner asserts that “the facility itself
is not making a profit and lost money in 2008.” P. Br. at 32. Petitioner also asserts that
“{a]ecording to the administrator, the facility would have closed, but for its parent
[company].” Jd. However, Petitioner has not provided any evidence to show that this
would preclude it from paying the proposed CMP.

With regard to the seriousness of the deficiency, Petitioner argues: this was an isolated
deficiency; no elopement occurred; and there has never been an elopement at the facility.
P. Br. at 32. As to culpability, Petitioner argues that the two exits were unforeseeable,
and no evidence exists that the facility was neglectful, indifferent, or disregarded the
resident’s comfort or safety. P. Br. at 33.

CMS asserts that given the absence of any security system or methodical monitoring in
the facility to protect elopement-risk residents, the CMP is reasonable. I agree. As
established above, the second exit was foreseeable, and the fact that the facility does not
view R6 as an elopement risk further illustrates their culpability and disregard for
resident’s safety. Ms. Brantley testified that, even if they had a Wanderguard system in
place, she would not have ordered a bracelet for R6, which would trigger an alarm when
R6 attempted to exit the facility. Tr. at 497. Petitioner presented no evidence that any
methodical monitoring or intervention of any type was put into place for R6’s safety in
regard to R6’s elopement risk. Thus, I find Petitioner culpable.

At $3,550 per day, the imposed penalty is at the low end of the range for an immediate
jeopardy level penalty. The seriousness of Petitioner’s noncompliance and Petitioner’s
25

culpability for failing to provide R6 with adequate supervision to mitigate foreseeable
risks of harm from accidents justify the penalty imposed.

b. The imposed CMP of $100 per day from February 7, 2008 through
March 17, 2008 is reasonable.

The lower range of CMP, from $50 per day to $3,000 per day, is reserved for deficiencies
that do not constitute 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
CFR. § 488.438(a)(1)(ii).

CMS seeks to impose a lower-range CMP of $100 per day from February 7, 2008
through March 17, 2008, for a total lower-range CMP of $3,900.

Petitioner does not argue that the duration of the penalty is incorrect. Jd. Petitioner does
not discuss the non-immediate jeopardy deficiencies in its assertion that the CMP was
unreasonable but instead limits its discussion to the immediate jeopardy finding. P. Br. at
31-33. All of Petitioner’s arguments relate to the Tag F 323 and whether an elopement
occurred. Jd.

The Tag F 323 continued after the immediate jeopardy was abated, as a lower level
deficiency. For the same reasons stated for the immediate jeopardy penalty, I find that
deficiency alone is sufficient to uphold a CMP of $100 per day.

As noted above in my discussion of three of the five lower level deficiencies, I also find
Petitioner culpable for these deficiencies, which are also sufficient to uphold the CMP.
At $100 per day, this imposed penalty is at the low end of the range for a non-immediate
jeopardy level penalty. I find it to be reasonable.

V. Conclusion

Based on my review of all of the evidence in this case, I find Petitioner out of substantial
compliance with the participation requirements of 42 C.F.R. § 483.25(h) at a level of
immediate jeopardy. I also find Petitioner out of compliance with participation
requirements at a non-immediate jeopardy level. I further sustain, and I find reasonable
the remedies that CMS imposed, including CMPs totaling $266,600, and the loss of
NATCEP.

/s/
Alfonso J. Montafio
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Omni Manor Nursing Home,
(CCN: 36-5433),
Petitioner,
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-08-760
Decision No. CR2213
Date: August 12, 2010

DECISION GRANTING SUMMARY JUDGMENT TO
CENTERS FOR MEDICARE AND MEDICAID SERVICES

I grant summary judgment to the Centers for Medicare and Medicaid Services (CMS)
sustaining CMS’s determination to impose civil money penalties against Petitioner, Omni
Manor Nursing Home, of $550 per day for each day of a period beginning on April 24,
2008 and running through May 21, 2008.

I. Background

Petitioner is a skilled nursing facility in Youngstown, Ohio. It participates in the
Medicare program. Its participation in Medicare is governed by sections 1819 and 1866
of the Social Security Act and by implementing regulations at 42 C.F.R. Parts 483 and
488. Its hearing rights are governed by regulations at 42 C.F.R. Part 498.

A compliance survey of Petitioner’s facility was conducted on April 24, 2008 (April
Survey). The surveyors who conducted this survey found that Petitioner had failed to
comply substantially with several Medicare participation requirements.' CMS concurred
with these findings and imposed the civil money penalties that I describe in the opening
paragraph of this decision.

Petitioner requested a hearing and the case was assigned to Alfonso J. Montano, an
administrative law judge of the Departmental Appeals Board Civil Remedies Division.
The case was developed extensively before Judge Montano. CMS filed 24 proposed
exhibits that it identified as CMS Ex. 1 - CMS Ex. 24. Petitioner filed 47 proposed
exhibits that it identified as P. Ex. 1 — P. Ex. 47.

During the course of pre-hearing development the case was narrowed to a single issue,
that being the date when Petitioner attained substantial compliance with Medicare
participation requirements. In other words, Petitioner does not challenge the
noncompliance findings made by the surveyors at the April Survey and concurred in by
CMS, nor does it assert that the $550 daily civil money penalty amount that CMS
determined to impose is unreasonable. It argues only that it attained substantial
compliance with participation requirements on a date that is earlier than that which CMS
found to be the date of compliance (April 29, 2008 versus May 22, 2008).

CMS moved for summary judgment on the issue of duration of noncompliance and
Petitioner opposed the motion. With its opposition Petitioner filed two additional
exhibits that it identified as P. Ex. 48 (Trexler Declaration) and P. Ex. 49. Judge
Montano permitted the parties a second round of briefing on the merits of CMS’s motion.
On June 21, 2010, he issued a ruling denying the motion.

The case was then transferred to me for a hearing and a decision. On August 3, 2010, I
vacated Judge Montano’s ruling denying the motion for summary judgment and advised
the parties that I would reconsider the motion.

I receive into the record of this case CMS Ex. 1 — CMS Ex. 24 and P. Ex. 1 — P. Ex. 49.

' There was also a Life Safety Code survey that found noncompliance. The
noncompliance that was found at this survey is no longer at issue and I do not address it
in this decision.

> Additionally, and by virtue of CMS’s noncompliance findings, Petitioner lost the
authority to conduct nurse aide training, certification, and education (NATCEP). The
loss of authority to conduct NATCEP is not challenged.
IL. Issues, findings of fact and conclusions of law
A. Issue

The issue in this case is the duration of Petitioner’s noncompliance with Medicare
participation requirements.

B. Findings of fact and conclusions of law

In deciding a motion for summary judgment, I apply the principles of Rule 56 of the
Federal Rules of Civil Procedure. Summary judgment is appropriate where a case rests
on issues of law or on application of law to undisputed facts. I may not enter summary
judgment where there are disputed issues of material fact. A “material fact” is one which
may affect the outcome of a case. In deciding whether a dispute exists as to a material
fact, I must draw all reasonable inferences in favor of the party opposing the motion for
summary judgment.

In this case I find that CMS is entitled to summary judgment as a matter of law. There is
no dispute that, as of April 24, 2008, Petitioner failed to comply substantially with
several Medicare participation requirements. Nor is there any dispute that CMS
determined that Petitioner attained compliance with these requirements effective May 22,
2008. Petitioner contends that there are facts showing that it actually attained compliance
on April 29, 2008. However, and as I explain in detail, the facts offered by Petitioner
would not establish compliance on a date that is earlier than May 22, 2008 because they
are legally insufficient to prove compliance. Consequently, I sustain CMS’s
determination.

I make the following findings of fact and conclusions of law (Findings).

I. As a matter of law and given the nature of Petitioner’s
noncompliance, Petitioner may not establish compliance at a date that
is earlier than the date of an on-site revisit survey of Petitioner’s

facility.

It is undisputed that Petitioner’s noncompliance as of April 24, 2008 included several
instances in which the manner in which the quality of care that Petitioner’s staff provided
residents was inadequate. These deficiencies included Petitioner’s failure to comply
substantially with the requirements of 42 C.F.R. §§ 483.25; 483.25(d); 483.25(g)(2);
483.25(h); 483.25(m)(1); and 483.65(a). Specifically, Petitioner’s staff failed to:
e Provide one of its residents with necessary care and services in order to maintain
the highest practicable physical, mental, and psychosocial well-being, in
accordance with that resident’s comprehensive assessment and plan of care. CMS
Ex. 5 at 5-8. Petitioner’s staff delayed providing the resident with treatment for
the resident’s respiratory problems even as the resident’s medical condition
rapidly deteriorated and failed to improve. Jd.;

e Provide proper urinary incontinence care to a resident by failing to remove a
resident’s Foley catheter timely. CMS Ex. 5 at 10-15;

e Ensure that a resident who was being fed by a gastrostomy tube received
medications administered using the correct technique. CMS Ex. 5 at 15-16;

e Ensure that the facility was free of accident hazards in that they failed to secure
potentially dangerous items (spray disinfectant and razors) in a shower room that
was accessible to independently mobile, but cognitively impaired residents. CMS
Ex. 5 at 16-18;

e Ensure that Petitioner had a medication administration error rate of less than five
percent. CMS Ex. 5 at 18-21; and

e Establish and maintain an infection control program designed to provide a safe,
sanitary, and comfortable environment and to prevent the development and
transmission of disease and infection, by failing to provide proper incontinence
care to a resident.

The undisputed facts establish that these deficiencies share a feature in that each involved
a failure by Petitioner’s nursing staff to comply with recognized standards of nursing
care. The noncompliance thus was, in every single instance, one of human error in
providing care.

Where CMS imposes a remedy to address a deficiency or deficiencies that remedy will
continue in effect until:

The facility has achieved substantial compliance, as determined by CMS or
the State based upon a revisit or after an examination of credible written
evidence that it can verify without an on-site visit; ....

42 C.F.R. § 488.454(a)(1). The regulation does not specify the circumstances where a
revisit is necessary or where CMS might be able to verify written evidence of compliance
without revisiting a facility. That issue was addressed in the Secretary’s comments in the
preamble to the Part 488 regulations:
There are other cases in which documentation cannot confirm the
correction of noncompliance, and in these cases an on-site revisit is
necessary. For example, one of the requirements for Infection Control is
that personnel must handle, store, process and transport linens so as to
prevent the spread of infection as specified in § 483.65. Ifa deficiency is
cited for a violation of this requirement and a civil monetary penalty is
imposed, submitting written documentation would not confirm the
correction of the violation. An on-site revisit to observe personnel behavior
is necessary in this case to confirm that the facility is, in fact, back in
substantial compliance with this regulatory provision.

59 Fed. Reg. 56207 (November 10, 1994). The preamble clarifies the regulation by
defining the circumstances in which documentation alone will not serve to establish
compliance. Deficiencies that involve staff members’ providing care to residents are not
deficiencies that normally can be certified as corrected based solely on a review of
documents because documents alone cannot prove that staff is actually providing care
according to professionally recognized standards of care. For such deficiencies,
observation of performance is a critical element of certifying compliance.?

The deficiencies that I describe above all fall into the category of deficiencies that cannot
be certified as having been corrected based solely on documents. Each of these
deficiencies is, at bottom, a failure by Petitioner’s staff to provide care to residents in
accord with professionally recognized standards of care. For example, Petitioner’s staff
was found to have failed to provide a resident with proper incontinence care. Retraining
the staff in the correct performance of incontinence care certainly is a critical part of
correcting this deficiency. But, retraining alone is not sufficient. There must be proof
that the staff absorbed the information provided by the retraining and that they are
applying it in practice. That aspect of compliance cannot be established simply by
documents but requires observation.

Thus, and as a matter of law, Petitioner could not establish compliance with the
deficiencies that I describe in this Finding based solely on documents representing that its
staff had been retrained or even that they were performing according to professionally
recognized standards of care. What was minimally necessary to establishing compliance
was that the staff be observed actually providing the care implicated in the deficiencies
and providing it according to professionally recognized standards of care. Certification

* There are some deficiencies where correction can be certified based on documents. For
example, a Life Safety Code deficiency might be based on the failure of a specific piece
of equipment at a facility. In that circumstance, a facility might be able to prove
compliance by offering written proof that the faulty piece of equipment had been repaired
or replaced.
of that required a revisit to the facility. In this case the revisit occurred on May 22, 2008
and that date is as a matter of law the earliest date on which CMS could have certified
Petitioner as compliant.

Petitioner makes several arguments in opposition to CMS’s motion and to the analysis
that I have just given. I find them to be without merit.

Petitioner argues that it “corrected each deficiency through a variety of in-service
training, counseling, education and investigation,” citing as support for this contention
the affidavit of Paulette Trexler, Petitioner’s quality assurance director. Petitioner’s
Memorandum in Opposition to CMS’s Motion for Summary Judgment (Petitioner’s brief
in opposition) at 2; P. Ex. 48. However, and as is evident from Ms. Trexler’s affidavit,
all of the evidence cited by Petitioner is in the form of documents that it or its staff
generated. In other words, Petitioner relies precisely on documentary evidence that is as
a matter of law insufficient to prove compliance. Indeed, on close examination it
becomes obvious that Petitioner’s contention that it attained compliance earlier than the
May 22, 2008 revisit rests entirely on documents which Petitioner offers to show that
staff members were retrained or that policies were written and implemented. P. Ex. 49.*

Petitioner contends that “there is no evidence submitted by CMS to support that it
actually conducted the types of investigatory and monitoring activities supposedly
underpinning the ‘comments’ made by the Secretary to the ‘Preamble to 42 CFR Part
488.’” Petitioner’s brief in opposition at 3. In effect, Petitioner argues that the surveyors
did a poor job at the revisit and, therefore, their findings should not control. This
argument misses the point. Whether the surveyors did a good job or a bad job on May
22, 2008 is not an issue in this case. As a matter of law, CMS is entitled to rely on the
revisit findings and to assume that, if the surveyors conclude that compliance has been
attained, that the surveyors performed the revisit correctly. Thus, a survey’s finding may
not be invalidated by the argument that the surveyors did not follow survey protocol or
that they did a poor job. 42 C.F.R. § 488.318(b).

Moreover, if Petitioner’s argument were followed to its logical conclusion it would mean
only that there is insufficient evidence to prove that Petitioner attained compliance as of
the revisit. That conclusion benefits Petitioner not at all because it does not permit me to
infer that Petitioner attained compliance prior to the revisit.

* It would have been insufficient as a matter of law even if Petitioner had provided
affidavits of individuals certifying that they had observed personally staff providing care
consistent with regulatory requirements because the regulations make it plain that CMS
or its delegate, a State survey agency, must make that observation in order for it to have
meaning. 42 C.F.R. § 488.454(a)(1).
Petitioner then attacks CMS’s argument that the preamble to the Part 488 regulations
provides guidance as to the regulations’ interpretation. “Necessarily, a Preamble is not
law. It is, by its nature and definition, something preliminary, not interpretative, and
nothing which constitutes enforcement.” Petitioner’s brief in opposition at 3. I agree that
the preamble to the regulations does not have the legal effect of the regulations
themselves. But, Petitioner is incorrect in arguing that the preamble has no value as an
interpretive document. It is, in fact, the Secretary’s guidance as to how she wants the
regulations to be interpreted and applied and is, therefore, a highly influential policy
statement.

But, according to Petitioner, even if the preamble has some interpretive value it gives no
meaningful guidance in this case. That is so, Petitioner contends, because: “The
Preamble mentioned by CMS says nothing about any tag at issue. Not one.” Petitioner’s
brief in opposition at 3-4. That assertion is incorrect inasmuch as the example cited in
the preamble is 42 C.F.R. § 483.65, governing infection control, and Petitioner
contravened this regulation. More to the point, however, Petitioner’s argument distorts
the meaning of the preamble and the guidance that it gives.

The preamble language that I have cited in this decision is not — as Petitioner seems to
assert — intended to list those regulatory sections for which onsite surveys must be held in
order to verify compliance. Rather, and using 42 C.F.R. § 483.65 as an example, it lays
out a principled basis for deciding when a resurvey is necessary in order to verify
compliance. It explains that a resurvey is always necessary when noncompliance
involves failure by facility staff to provide care in accordance with accepted standards of
care. As I discuss above, all of the deficiencies that I address in this decision are
deficiencies that involve precisely the types of human error that necessitate a resurvey in
order to verify compliance with participation requirements.

Petitioner also asserts that its plan of correction establishes that compliance with
participation requirements was attained by April 29, 2008, five days after the April
Survey. Petitioner’s brief in opposition at 4. I have explained already why Petitioner’s
documents cannot establish compliance with participation requirements. Furthermore, a
plan of correction, by definition, is not evidence that a facility has attained compliance. It
is merely a promise by a facility to attain compliance. It does not document what a
facility has done to attain compliance; rather, it documents what a facility pledges to do.

In this case, Petitioner’s plan of correction does not even promise that compliance will be
attained by April 29, 2008. Although it lists “4/29/08” as the completion date of
proposed corrective actions, the plan actually describes corrective actions that would
require as much as a month to complete. CMS Ex. 5 at 5-6, 14, 15, 17, 21, 24. For
example, in pledging to correct its noncompliance with the requirements of 42 C.F.R.

§ 483.25, Petitioner asserts that corrective actions:
will be monitored through chart audits on residents exhibiting a change in
condition by Assistant DON [director of nursing], Clinical Director, QA
[quality assurance] Nurse 5 x week x 2 weeks then 3 x week x 2 weeks then
randomly thereafter.

CMS Ex. 5 at 5. In addressing the same deficiency, Petitioner avers that discharge
records would be reviewed for one month. Id. at 6.

Petitioner avers that State survey agency staff told Petitioner that they would certify that
compliance was attained by April 29, 2008. Petitioner’s brief in opposition at 4. That
assertion is irrelevant. It is not a State survey agency or its employees, but CMS that
determines when compliance is attained.

Finally, Petitioner argues that it is unfair to make compliance contingent on a revisit. It
raises the question of the situation in which CMS or a State survey agency unreasonably
delays conducting the revisit, thereby causing penalties to accrue by virtue of the delay
even though the facility’s staff is providing care consistent with applicable standards of
care. I do not need to consider that issue here because, in this case, the State survey
agency actually revisited Petitioner prior to the dates when Petitioner represented that it
would attain compliance with participation requirements. See CMS Ex. 5 at 5-6, 14, 15,
17, 21, 24.

2. Petitioner attained compliance with participation requirements
effective May 22, 2008. Therefore, CMS may impose a civil money
penalty of $550 per day for each day of a period that began on April
24, 2008 and ran through May 21, 2008.

As a matter of law Petitioner could not attain compliance prior to the revisit of May 22,
2008. Consequently, CMS is authorized to impose a civil money penalty of $550 a day
for each day of the period that began on April 24, 2008 and ran through May 21, 2008.

/s/
Steven T. Kessel
Administrative Law Judge