Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

)
In the Case of: )
)
Mitchell Village Care Center, ) Date: April 20, 2007

(CCN: 16-5264), )
)

Petitioner, ) Docket No. C-04-264

) Decision No. CR1589
v. )
)
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, Mitchell Village, violated 42 C.F.R. § 483.25(h)(2) on January 2, 2004. There
is a basis for the imposition of an enforcement remedy. A per-instance civil money
penalty (PICMP) of $3000 is a reasonable remedy.

I. Background

Mitchell Village Care Center, Petitioner, is a long-term care facility located in
Mitchellville, Iowa. Petitioner participates in the Medicare and Medicaid programs.
From January 5 through 7, 2004, the lowa Department of Inspections & Appeals (the
state agency) conducted a complaint survey of Petitioner and found that Petitioner was
not in substantial compliance with Medicare and Medicaid participation requirements.
The state agency cited Petitioner for violation of 42 C.F.R. § 483.25(h)(2) (Tag F 324)!
and alleged that the deficiency presented immediate jeopardy for Petitioner’s residents.

' All references are to the revision of the Code of Federal Regulations (C.F.R.) in
effect at the time of the survey, unless otherwise indicated. The “Tag” designation refers
to the part of the State Operations Manual (SOM), Appendix PP, “Survey Protocol for
Long Term Care Facilities,” “Guidance to Surveyors” that pertains to the specific
regulatory provision allegedly violated.
2

The Centers for Medicare and Medicaid Services (CMS) notified Petitioner by letter
dated January 28, 2004, that it concurred with the state agency finding that Petitioner was
not in substantial compliance and that that condition posed immediate jeopardy for
Petitioner’s residents. Request for Hearing, Exhibit A. CMS acknowledged in its
January 28 letter that the state agency found that Petitioner had removed immediate
jeopardy before the state agency exited the facility. However, CMS indicates that
Petitioner continued to be out of substantial compliance and the continued noncompliance
posed the possibility of actual harm to residents. CMS advised Petitioner that it was
imposing a $3000 PICMP, as recommended by the state agency. CMS advised Petitioner
that if substantial compliance was not achieved by April 16, 2004, a denial of payments
for new admissions would also be imposed and that its provider agreement would be
terminated if substantial compliance was not achieved by July 16, 2004. The denial of
payment and termination remedies were not imposed as Petitioner returned to substantial
compliance.

Petitioner filed a request for a hearing on March 26, 2004. The case was assigned to me
for hearing and decision. I conducted a two-day hearing in this case on February 28 and
March 1, 2005 and a transcript (Tr.) of the proceeding has been prepared. CMS offered
and J admitted CMS exhibits (CMS Exs.) 1 through 4. Petitioner offered and I admitted
Petitioner Exhibits (P. Exs.) 1 through 6. Petitioner filed a post-hearing brief (P. Br.) and
reply ( P. Reply). CMS filed its post-hearing brief (CMS Br.) and reply (CMS Reply).

II. Discussion
A. Findings of Fact

The following findings of fact are based upon the exhibits admitted. Citations to exhibit
numbers related to each finding of fact may be found in the analysis section of this
decision if not indicated here.

1. Resident | is an 83-year-old, five-foot, one-inch, 105-pound female with diagnoses
of dementia, progressive Alzheimer’s disease, delusional behavior and chronic
anxiety. Joint Statement of Undisputed Facts (Jt. Statement); CMS Ex. 2, at 67-68,
88-107; P. Ex. 3.

2. Resident | was not to be outside Petitioner’s facility, unless accompanied by staff
or family. Jt. Statement.
10.

3

Resident 1’s records reflect that she could ambulate independently in her room and
required limited assistance outside her room, on and off the unit. Jt. Statement;
CMS Ex. 2, at 104-05.

Resident | had verbalized an intention to leave the facility prior to being
discovered alone outside the facility on January 2, 2004. Jt. Statement; CMS Ex.
2, at 58-59.

On December 31, 2003, two days prior to eloping on January 2, 2004, Resident 1
attempted to leave the facility by opening an exit door but an alarm sounded and
she was immediately redirected by staff. Jt. Statement; CMS Ex. 2, at 59.

On January 2, 2004, at approximately 7:00 a.m., Resident | was discovered on the
front lawn of a neighboring house by a neighbor, who notified Petitioner. CMS
Ex. 2, at 59-60; Jt. Statement.

An ambulance was summoned and when the crew arrived at 7:12 a.m. on January
2, 2004, they noted that Resident 1: had pale skin, shallow breathing, was cold to
the touch, and shaking; she was wearing shirt, pants, shoes, socks, and a coat had
been placed over her by a bystander; she had abrasions on her left and right knees;
the heat in the ambulance was turned-up to warm the resident; oxygen was
administered by nasal cannula due to the resident’s shallow breathing; and the
crew started a warm saline drip. CMS Ex. 2, at 114, 116, 118, 141-49; Jt.
Statement.

Resident | was taken by ambulance to the local hospital and treated for moderate
hypothermia. CMS Ex. 2, at 71-80, 118; Tr. 47.

Prior to being discovered outside the facility at approximately 7:00 a.m. on January
2, 2004, Petitioner’s staff last observed Resident 1 at approximately 5:30 a.m. in
the facility dining room not far from the front door. P. Ex. | at 2; CMS Ex. 2, at
12, 18.

Until a neighbor entered the facility and indicated that Resident 1 was “down the
road on the ground,” no one in the facility was aware that Resident 1 was missing.
P. Ex. 2, at 15.
Il.

12.

13.

4

The doors of Petitioner’s facility had alarms: the front door had an alarm that
sounded if the door was open from the outside without pushing a button or from
the inside without entering a code on a key-pad and, if the exterior button was
pushed or the code entered, the alarm would not sound for ten seconds to permit
entry or exit; the front door also had a WanderGuard™ alarm system that was
triggered whenever a resident wearing a WanderGuard™ bracelet approached the
door too closely; and the emergency exit doors at the end of each of three corridors
had an alarm that immediately sounded when the door was opened; and all the
alarms except the WanderGuard™ were controlled by a reset button and on and off
switches on a panel at the nurses’ station near the front door. Tr. 25-27, 139-42.

There was no report in facility records of an alarm sounding the morning of
January 2, 2004, between the time Resident 1 was observed at 5:30 a.m. and 7:00
a.m. when she was found outside. Jt. Statement.

Petitioner investigated but never determined how Resident 1 eloped from the
facility without notice; Petitioner could not determine whether the alarm was
turned off; the alarm failed; or whether Resident 1 eloped during the alarm delay
which occurred when employees were arriving or leaving the morning of January
2, 2004.

B. Conclusions of Law

Petitioner’s request for hearing was timely and I have jurisdiction.

Petitioner violated 42 C.F.R. § 483.25(h)(2) (Tag F 324) on January 2, 2004.

Petitioner has failed to rebut the CMS prima facie showing of a violation of 42
C.F.R. § 483.25(h)(2) on January 2, 2004.

There is a basis for the imposition of a PICMP.

A PICMP of $3000 is reasonable considering the regulatory factors at 42 C.F.R. §
488.438(e).
C. Issues
The general issues are:

1, Whether there is a basis for the imposition of an enforcement remedy;
and,

2. Whether the remedy imposed is reasonable.
D. Applicable Law

Petitioner is a long-term care facility participating in the federal Medicare program as a
skilled nursing facility (SNF) and in the state Medicaid program as a nursing facility
(NF). The statutory and regulatory requirements for participation by a long-term care
facility are found at sections 1819 and 1919 of the Social Security Act (Act) and at 42
C.F.R. Part 483. Sections 1819 and 1919 of the Act vest the Secretary of Health and
Human Services with authority to impose civil money penalties against a long-term care
facility for failure to comply substantially with federal participation requirements.

Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey
agencies in order to determine whether the facilities are complying with federal
participation requirements. 42 C.F.R. §§ 488.10-488.28, 488.300-488.335. Pursuant to
42 C.F.R. Part 488, CMS may impose a per-instance or per day CMP against a long-term
care facility when a state survey agency concludes that the facility is not complying
substantially with federal 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.

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 CMP, from $3050 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 $3000 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 $1000 to $10,000 for a PICMP that
applies whether or not immediate jeopardy is present. 42 C.F.R. §§ 488.408(d)(1)(iv);
488.438(a)(2).
6

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, et al, DAB CR65 (1990), aff'd, 941 F.2d 678
(8" Cir. 1991); Emerald Oaks, DAB No. 1800, at 11 (2001); Beechwood Sanitarium,
DAB No. 1906 (2004); Cal Turner Extended Care, DAB No. 2030 (2006); The Residence
at Salem Woods, DAB No. 2052, (2006). 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
also 42 C.F.R. §§ 488.330(e) and 498.3. However, the choice of remedies by CMS or the
factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. §
488.408(g)(2). A facility may only challenge the scope and severity level of
noncompliance found by CMS if a successful challenge would affect the amount of the
CMP that could be collected by CMS or impact upon the facility’s nurse aide training
program. 42 C.F.R. §§ 498.3(b)(14) and (d)(10)(i). 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
Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363
F.3d 583 (6" Cir. 2003). The Departmental Appeals Board (the 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 in the situation 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). Review of a CMP by
an ALJ is governed by 42 C.F.R. § 488.438(e).

When a penalty is proposed and appealed, CMS must make a prima facie case that the
facility has failed to comply substantially with federal participation requirements. “‘Prima
facie” means that the evidence is “(s)ufficient to establish a fact or raise a presumption
unless disproved or rebutted. Black’s Law Dictionary 1228 (8" ed. 2004), see also,
Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd Hillman Rehabilitation
Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999).
To prevail, a long-term care facility must overcome CMS’s showing by a preponderance
of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004);
Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No.
1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Evergreene
Nursing Care Center, DAB No. 2069, at 7-8 (2007).
E. Analysis

1. Petitioner violated 42 C.F.R. § 483.25(h)(2) (Tag F 324) and there is
a basis for imposing a CMP.

A facility must ensure that “[e]ach resident receives adequate supervision and assistance
devices to prevent accidents.” 42 C.F.R. § 483.25(h)(2). The Board has explained the
requirements of 42 C.F.R. § 483.25(h)(2) in numerous decisions. Golden Age Skilled
Nursing & Rehabilitation Center, DAB No. 2026 (2006); Estes Nursing Facility Civic
Center, DAB No. 2000 (2005); Northeastern Ohio Alzheimer's Research Center, DAB
No. 1935 (2004); Woodstock Care Center, DAB No. 1726, at 28 (2000), aff'd, Woodstock
Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). Section 483.25(h)(2) does not
make a facility strictly liable for accidents that occur, but it does require 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. Woodstock Care Center v. Thompson, 363 F.3d at 590 (a SNF must take “all
reasonable precautions against residents’ accidents”). A facility is permitted the
flexibility to choose the methods of supervision it uses to prevent accidents, but the
chosen methods must be adequate under the circumstances. Jd. Whether supervision is’
“adequate” depends in part upon the resident’s ability to protect himself or herself from
harm. /d. Based on the regulation and the cases in this area, CMS meets its burden to
show a prima facie case if the evidence demonstrates that the facility failed to provide
adequate supervision and assistance devices to prevent accidents, given what was
reasonably foreseeable. Alden Town Manor Rehabilitation & HCC, DAB No. 2054
(2006), at 5-6, 7-12. An "accident" is "an unexpected, unintended event that can cause a
resident bodily injury," excluding "adverse outcomes associated as a direct consequence
of treatment or care (e.g., drug side effects or reactions)." State Operations Manual
(SOM), App. P, page PP-105, Guidance to Surveyors for Long Term Care Facilities, Part
2, F324, Quality of Care (Rev. 274, June 1995), Woodstock Care Center, DAB No. 1726,
at 4 (2000).

Resident | was an 83-year old female resident at Petitioner’s facility. Her Minimum Data
Set Quarterly Assessment (MDS), assessment reference date of October 10, 2003, reflects
that she was moderately impaired for daily decision-making, i.e., she made poor decisions
and required cues and/or supervision; she had short and long-term memory deficits; she
had indicators of delirium or periodic disordered thinking and/or awareness; a depressed
mood that was not easily altered; she had a history of falls within the past 180 days; and
she received both antipsychotic and antidepressant medication. Resident 1 was
independent for ambulation in her room but needed limited assistance with ambulation
outside her room, on and off the unit. CMS Ex. 2, at 104-06. Resident | was assessed at
“high risk for injury related to impaired cognition manifested by need for assistance at
8

times with ambulation/locomotion” and her care plan dated October 14, 2003, specified
“utilize door alarms.” CMS Ex. 2, at 98. According to the resident’s clinical record, she
suffered from progressive Alzheimer’s disease, chronic anxiety, delusional behavior, and
depression, among other things. CMS Ex. 2, at 67, 88-107; P. Ex. 3.

The parties stipulated that at approximately 7:04 a.m. on Friday, January 2, 2004,
Resident | was discovered by a neighbor outside the facility lying on the front lawn of a
nearby residence. Emergency medical services personnel were called and the resident
was transported to the hospital where she was treated for hypothermia and abrasions to
her knees and subsequently returned to Petitioner on January 4, 2004. CMS Ex. 2, at 60,
71-80. The parties agree that Resident 1 was not supposed to be outside Petitioner’s
facility unless accompanied by facility staff or a family member. Jt. Statement. The
parties also stipulated that prior to the elopement that caused the deficiency citation,
Resident 1 had verbalized an intention to the leave the facility and, late on December 31,
2003, she opened a door with an alarm that sounded alerting staff to redirect her before
she escaped. Jt. Statement; CMS Ex. 2, at 59. On January 2, 2004, Resident | was last
seen by staff around 5:30 a.m. in the dining room of the facility near the front door. The
parties agree that no facility record reflects that a door alarm sounded between 5:30 a.m.
when Resident | was last seen by staff and roughly 7:00 a.m. when the neighbor triggered
the front door alarm when he entered the building to report he found Resident 1 on the
ground outside. Staff did report that the front door alarm sounded three times between
midnight and 7:00 a.m. on January 2, 2004. The first two instances of the alarm sounding
occurred between 4:40 a.m. and 4:45 a.m. when the paper boy arrived and then exited the
building.” The third alarm sounded when the neighbor entered around 7:00 a.m. to report
finding Resident 1. P. Ex. 1, at 2; Petitioner’s Proposed Findings of Fact No. 22; CMS’s
Proposed Findings of Fact.Nos. 41 and 54. The facility report of investigation related to
Resident |’s elopement reflects that several staff entered and exited the front door
between 5:40 a.m. and 6:20 a.m. on January 2, 2004. Staff entered and exited the front
door without triggering the door alarm, apparently, by pushing the outside button or
entering the correct code on the inside door keypad. When either the exterior button is

? LPN Janita Lansman testified that she had worked for Petitioner for over a year
and during that time the newspaper boy regularly set off the alarm around 4:40 a.m. _ Tr.
246, 255. Ms. Lansman agreed with my conclusion that, given earlier testimony
regarding the purported volume of the alarms, the alarm sounding at 4:40 a.m. must be
disturbing for the residents. Although this evidence supports Petitioner’s theory that its
alarms worked, it also suggests that the alarms may not have been particularly effective,
ie., if after a year no one came up with a solution for the paper boy triggering the alarm
nearly every morning how loud or bothersome were the alarms. Also, if the alarms were
being constantly triggered, one must question how effective they were to provoke an
appropriate staff response.
9

pushed or the code is correctly entered on the interior keypad, there is a 10 second delay
before the alarm resets and is active. P. Ex. 1, at 2-3; Tr. 25-27, 139-42, 225-28. During
its investigation, Petitioner’s staff was able to show that a person could slip out of the
facility from the dining room during the ten second delay without being seen. P. Ex. 1, at
3; Tr. 225-28.

The evidence establishes a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2)
in this case, i.e, CMS has produced sufficient evidence that, absent conflicting evidence,
shows a violation occurred. Meadow Wood Nursing Home, DAB No. 1841, at 7 (2002);
Emerald Oaks, DAB No. 1800, at 16 (2001). Resident 1 was outside the facility without
knowledge of the staff and without supervision. Thus, the burden is upon Petitioner to
either rebut the prima facie case or to show affirmatively, that more likely than not, it was
in substantial compliance. Emerald Oaks, at 16.

Petitioner argues that it appropriately assessed Resident | and that reliance upon its door
alarms was a reasonable intervention to address the foreseeable risk to the resident.
Petitioner asserts that it provided appropriate and adequate supervision to Resident 1.
Petitioner further contends that the fact that Resident 1 exited the building undetected
does not mean that it did not provide adequate supervision. P. Br. at 18-19; P. Reply at 9-
11. I conclude, however, that Petitioner has not rebutted the prima facie showing by
CMS or shown that it took all reasonable steps to ensure that Resident 1 received
supervision and assistance devices necessary to meet her assessed needs and mitigate
foreseeable risks of harm from accidents.

The evidence shows that Resident 1 left Petitioner’s facility without supervision
sometime between 5:30 a.m. and 7:00 a.m. on January 2, 2004. There is no question that
as a result of eloping, Resident 1 suffered abrasions and hypothermia, which is actual
harm. There is no question that Petitioner’s staff was unaware that Resident | left the
facility until a Good Samaritan found her and reported the discovery. Petitioner could not
determine through its investigation how Resident | exited the building; whether she left
through the front door or another door is unclear. P. Ex. 1. Petitioner contends that since
no unaccounted for door alarms were heard and all systems were in operating order and
not deactivated, it did all that it was required to do to ensure that Resident | remained
inside. Petitioner also argues that it was not foreseeable that any resident could elope
given its alarm system, the maintenance and inspections of that system, and the fact that
no other resident had ever exited unsupervised by staff. P. Reply at 9. Petitioner’s
significant reliance on one mechanical means of supervising its residents who might seek
to exit its facility is troubling, even though I accept as fact Petitioner’s assertion that no
resident escaped in many years. No system, mechanical, electrical, or human is fool proof
and Resident | proved that point. It is not reasonable for a facility to rely upon a single
system or intervention to provide necessary supervision for its residents. Rather the
10

facility should be able to show that there are redundancies of protection or multiple
interventions that take into consideration the possibility of failure of a single intervention
or system and that also take into consideration the unique condition and needs of its
residents.

It was clearly foreseeable that Resident 1 was an elopement risk who required some
intervention in addition to reliance upon the door alarms to address that risk and the
related risk of accidental injury. On December 31, 2003, Resident 1 attempted to elope
but was caught when a door alarm sounded. There is no question that the resident also
verbalized an intent to leave the facility. Jt. Statement. The evidence does not show that
Petitioner took any action or made any intervention based upon the December 31, 2003
attempted elopement and the resident’s verbalization. A nursing noted related to that
incident shows Resident | was redirected, a facsimile was sent to her physician, but no
other interventions are noted. CMS Ex. 2, at 59. Testimony at hearing by Tina Steffen,
Petitioner’s Administrator, shows that only one staff member made the decision not to
make other interventions after the attempted elopement on December 31, 2003. Tr. 138,
236-37.

Petitioner points to the intervention on Resident 1’s care plan to “utilize door alarms”
(CMS Ex. 2 at 98), however Petitioner acknowledges that that intervention was based
upon an October 2003 assessment related to a goal for the resident to be free of injuries
from falls. P. Brief at 3. Petitioner has relied upon door alarms for years (P. Reply at 9)
apparently with success. However, Petitioner cannot argue that the intervention to use
door alarms was tailored particularly to provide necessary care and services to Resident 1.
Rather, it was the policy of Petitioner that doors be locked and/or alarmed. It is clear, that
the intervention on Resident 1’s care plan was not intended to address her attempted
elopement on December 31. Petitioner does not point to any intervention that was
adopted following the December 31 elopement attempt or the resident’s verbalizations.
Petitioner only added a WanderGuard® to the resident’s care plan after the January 2,
2004 elopement (CMS Ex. 2, at 97; P. Ex. 1, at 1). Following the December 31 attempted
elopement, no intervention was added to Resident 1’s care plan that required staff to do
regular or intermittent checks on her whereabouts despite her prior exit seeking behavior
barely two days earlier, her verbalizations, and the fact she normally liked to sit in the
dining area not far from the front door in the early morning (which is exactly where she
was last observed at 5:30 a.m. on January 2, 2004) (P. Ex. 1, at 2-3). Petitioner has not
produced evidence that its front door and dining area were subject to regular or constant
direct observation by staff in the early morning when this elopement apparently occurred,
despite the fact that the evidence shows much traffic through that door in the early
morning. Petitioner takes the unreasonable position that it is “unreasonable” to have
some member of its staff monitor who is coming and going from its facility. P. Brief at 8.
11

Petitioner’s theory that if CMS or the state agency cannot explain how Resident 1 exited
the building, then CMS cannot find that Petitioner was deficient, is ill-founded. P. Brief
at 12-18, P. Reply at 4-7. Petitioner cannot so easily avoid its obligation and its burden as
a provider to show it did all it reasonably could to protect Resident 1 from accidents. The.
exact means or route by which Resident 1 exited the facility undetected is not a necessary
element of the CMS prima facie case. Rather, the burden is on Petitioner to rebut the
CMS showing that Resident 1 was outside the facility and unsupervised or that it did all it
reasonably could to prevent that accident.

I conclude that Petitioner failed to do all it reasonably could to provide adequate
supervision to this resident: she was able to leave the facility undetected, no staff were
even aware that she was missing, and, as a consequence of this lack of supervision, she
suffered actual harm. To prevail, Petitioner must show that it took reasonable measures
to protect Resident 1 from accidents. Whatever system Petitioner chooses to use —
whether it is an alarm, one-to-one supervision, or someone stationed at the front door to
supervise entry and exit — must be adequate and appropriate to supervise the residents so
to minimize or prevent risks of accidents. Here Petitioner has not rebutted CMS’s prima
facie showing or shown affirmatively that it was in substantial compliance with the
regulatory requirement to provide adequate supervision and assistance devices. Petitioner
has not shown that it did all that it reasonably could do to protect Resident 1 from being
outside alone and unsupervised.

2. A PICMP of $3000 is reasonable on the facts of this case.

If a facility is not in substantial compliance with program requirements, CMS has the
authority to impose one or more of the enforcement remedies listed in 42 C.F.R. §
488.406, including a CMP. CMS may impose a CMP for the number of days that the
facility is not in compliance or for each instance that a facility is not in substantial
compliance. 42 C.F.R. § 488.430(a). The minimum amount for a PICMP is $1000 and
the maximum is $10,000. CMS imposed a per instance penalty here of $3000 — the low
end of the range. I must consider whether the proposed PICMP is reasonable.

In determining whether the amount of the per instance CMP is reasonable, the following
factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility’s history
of non-compliance, including repeated deficiencies; (2) the facility’s financial condition;
(3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404; and (4) the
facility’s degree of culpability.
12

Petitioner has not argued that the proposed PICMP is unreasonable but focused upon
whether or not there is a basis for imposing such a remedy. The PICMP amount is at the
low-end of the range. Petitioner has not argued or submitted any evidence that it is
unable to pay the PICMP. CMS has offered no evidence of past noncompliance for me to
consider. The deficiency is serious and supports the PICMP proposed. It was merely
fortuitous that the resident was discovered before she suffered more significant injury or
death. Respondent 1 did suffer actual harm, hypothermia and abrasions, and she was
hospitalized. Petitioner is culpable in this case for failure to assess and intervene to
address Resident 1’s attempted elopement and verbalizations and to adequately monitor
ingress and egress from its facility. Therefore, I conclude that given all the factors, a
PICMP of $3000 is reasonable.

III. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. § 483.25(h)(2)
and that a PICMP of $3000.00 is reasonable.

/s/

Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Decision No. CR1588
Centers for Medicare & Medicaid
Services.

In the Case of: )
)

Knox County Nursing Home, ) Date: April 19, 2007
(CCN: 145679/0010561), )
Petitioner, )
)

-V.- ) Docket No. C-06-500

)
)
)
)

RULING GRANTING CMS’S MOTION TO DISMISS

The Center for Medicare and Medicaid Services (CMS) moved to dismiss Petitioner’s
June 8, 2006 hearing request for untimeliness.' CMS filed a motion dated December 14,
2006, seeking dismissal of Petitioner’s hearing request, accompanied by a Memorandum
of Law (CMS Br.) and 12 proposed exhibits. I have admitted these into evidence as CMS
Exhibits 1-12 (CMS Exs. 1-12). Petitioner filed a memorandum in opposition (P. Br.)
and two proposed exhibits on February 12, 2007. I have admitted these into evidence as
Petitioner’s Exhibits 1-2 (P. Exs. 1-2).2 CMS submitted a reply brief (CMS Rep. Br.)
dated March 5, 2007.

' Although Petitioner’s request for hearing appears to lack the content and
specificity required by the applicable regulations, CMS seeks dismissal on grounds of
untimeliness. 42 C.F.R. § 498.40(b).

? Petitioner marked its two exhibits as Exhibits A and B. However, in order to
conform the identification of those documents to Civil Remedies Procedures, I have
redesignated them as P. Exs. | and 2.
Ww

1. Background of the case

This case is before me pursuant to Petitioner’s hearing request filed on June 8, 2006.
Petitioner is a skilled nursing facility in Knoxville, Illinois, participating in the Medicare
and Medicaid programs. As a result of a survey completed on December 7, 2005, the
Illinois Department of Public Health (IDPH) notified Petitioner that, based on findings of
immediate jeopardy, it was recommending that CMS impose a per instance civil money
penalty (PICMP) in the sum of $5,000.

On April 3, 2006, CMS notified Petitioner that it concurred with the recommendations of
the state survey agency and was imposing a PICMP. CMS further informed Petitioner
that if it disagreed with that determination, a hearing was available before an
administrative law judge (ALJ), and that the procedures governing this process are set out
at 42 C.F.R. § 498.40, et seq. CMS Ex. 8,.at 4. Petitioner reccived the notice on April 7,
2006. CMS Ex. II, at 6.

After consideration of the written arguments and documentary evidence submitted by the
parties, | grant CMS’s motion to dismiss. In doing so, I find that the hearing request was
untimely filed and the time for filing a request for hearing has not been extended as
Petitioner has not shown good cause for its failure to file a timely hearing request.

Il. Issues
The issues in this case are:
. Whether Petitioner filed a timely request for hearing; and,

. Whether Petitioner has shown good cause for extending the time to file a
request for hearing.

III. Applicable law and regulations

In cases involving CMS, a party is entitled to a hearing only if that party files its request
within the time limits established by 42 C.F.R. § 498.40(a)(2), unless the period for filing
is extended. In order to be entitled to a hearing, a party must file its request within 60 days
from receipt of a notice of a determination by CMS to impose a remedy. The date of
receipt of a notice is presumed to be five days after the date on the notice, unless there is a
showing of actual receipt on an earlier or later date. 42 C.F.R. § 498.22(b)(3). An ALJ
may extend the time within which a hearing request may be filed based on a showing of
good cause to justify an extension of time. 42 C.F.R. § 498.40(c)(2). An ALJ may
dismiss a request for hearing which is not timely filed. 42 C.F.R. § 498.70(c).
IV. Findings and Discussion

| make findings of fact and conclusions of law (Findings) to support my decision to
dismiss the request for hearing. Each finding is noted below in bold, italic face, followed
by a discussion of each Finding.

A. Petitioner did not file a timely request for hearing.

CMS sent Petitioner the notice of deficiencies by certified mail on April 3, 2006. CMS
Ex. I 1. Petitioner does not dispute that it received CMS’s notice on April 7, 2006. P. Br.
at 1, para. 6. It was not until June 8, 2006, 62 days after Petitioner’s receipt of CMS’s
determination, that Petitioner filed a request for a hearing before an ALJ.

42 C.F.R. § 498.40(a)(2) expressly provides that:

{an] affected party or its legal representative or other authorized official must file
the request for hearing in writing within 60 days from the receipt of the notice of
initial, reconsidered, or revised determination unless that period is extended... .

The filing of Petitioner’s request was clearly beyond the 60 days stipulated in the
regulations. Also, 42 C.F.R. § 498.22(b)(3) provides that “the receipt of the notice of [an]
initial determination . . . will be presumed to be 5 days after the date of the notice unless
there is a showing that it was, in fact, received earlier or later.” The five-day presumption
set forth at 42 C.F.R. § 498.22(b)(3) does not apply here, since Petitioner received CMS’s
notice 4 days after the date of the notice. CMS Ex. 11, at 6. Thus, the time for seeking a
hearing before an ALJ expired on June 6, 2006.

B. Petitioner is not entitled to an extension of time to file a request for hearing.

Petitioner has not filed a request for an extension of time for filing its request for hearing
pursuant to 42 C.F.R. § 498.40(c)(1). Notwithstanding, I will consider its memorandum in
opposition to CMS’s motion for dismissal as an application for leave to file untimely,
which I may grant only upon a showing of good cause. 42 C.F.R. § 498.40(c)(2).

1. Petitioner’s arguments.

Petitioner contends that in a telephone conversation on April 17, 2006, Ms. Marianne
Wiesen, the facility administrator, was told by Ms. Ellen B. Greif, Principal Program
Representative/Acting Branch Manager, CMS (Region V), that the facility had until June
10, 2006, for filing a request for hearing. Consequently, the facility relied on the
assertion of the CMS representative in filing the request on June 8, 2006. Thus, Ms.
4

Wiesen’s trust of the advice given to her by Ms. Greif is the basis for which the facility
filed its request on June 8, 2006, two days after the 60 day period had ended. P. Br. at 1;
PL Ex. 1.

Petitioner claims that because it relied on erroncous information provided by CMS as to
the expiration of the time to file a request for hearing, the interests of justice and the
discretion of the Departmental Appeals Board should permit this case to go forward.
Furthermore, Petitioner posits that the present situation calls for equitable exercise of the
ALJ's powers to insure that the facility be given an opportunity to be heard on its request
for hearing. P. Br. at 2. Petitioner cites United States v. Morton Salt Co., 338 U.S. 632
(1950) in support of his contention. This case has to do with a controversy as to the
power of the Federal Trade Commission to require corporations to file reports showing
how they have complied with a decree of the Court of Appeals enforcing the
Commission’s cease and desist order, in addition to those reports required by the decree
itself. Petitioner merely mentions the case but fails to explain how it is relevant to the
issue before me.

2. CMS's arguments.

CMS, on the other hand, contends that Petitioner has failed to preserve its right to contest
the finding of noncompliance cited during the December 7, 2005-survey because its
hearing request was not timely filed. CMS maintains that Petitioner had 60 days from the
date of receipt of the April 3, 2006-notice to appeal the finding of noncompliance as well
as the imposition of the $5,000 PICMP. CMS adds that because the facility did not file
its request for hearing until June 8, 2006, the 62" day, and has offered no good cause for
extending the time period to appeal, the finding of noncompliance at Tag F323, cited
during the December 7, 2005-survey, has become final and not subject to review. CMS
also alleges that Petitioner has failed to preserve its right to appeal the findings of
noncompliance cited during the August 10, 2005 and September 27, 2005 surveys. The
deficiencies in those surveys provide a basis for the denial of payment for new admissions
(DPNA) imposed by the State of Illinois effective November 10, 2005 through December
24, 2005. The IDPH notified Petitioner that it had 60 days from the date of receipt of the
October 5, 2005 imposition of remedies to file an appeal of the DPNA; that is, December
9, 2005. Thus, it is CMS’s position that inasmuch as Petitioner did not file its hearing
request until June 8, 2006, approximately six months later, and has offered no good cause
for extending the time period to appeal, the findings regarding imposition of the DPNA
are also final and not subject to review. CMS Br. at 7, 8; CMS Exs. 3, 5.
5

Finally, CMS posits that even if an official of the agency informed the facility
administrator during a telephone conversation that an appeal did not have to be filed until
June 10, 2006, it had no reasonable basis to rely on that oral advice to the detriment of
what it had already learned from the written notice, which required that a hearing request
be filed by June 6, 2006. CMS Rep. Br. at 5.

3. Discussion.

The fundamental issue to be decided here is whether Petitioner has shown good cause to
extend the time to file a request for hearing beyond the 60 days provided in the
regulations. 42 C.F.R. §§ 498.40(c)(1), (c)(2). Inasmuch as what constitutes good cause
is not defined in the regulations, | must look to case law for guidance in pursuit of a
definition. The Departmental Appeals Board has held that “good cause” means
circumstances beyond an entity’s ability to control which prevented it from making a
timely request for hearing. Hospicio San Martin, DAB No. 1554, at 5 (1996).

In view of the foregoing, I examine the facts of this case to determine what
circumstances, if any, beyond Petitioner's control, prevented it from filing a timely
hearing request. The thrust of Petitioner's argument in addressing this issue is two-
pronged:

. The facility filed the request for hearing late because it relied on the
assertion of the CMS representative that it had until June 10, 2006 to do so.

. Because the facility relied on erroneous information provided by CMS as to
the expiration of the time to file a request for hearing, | should exercise
equitable powers to permit this vase to go forward.

The notices of imposition of sanctions dated October 5, 2005 and April 3, 2006, under a
heading titled “Appeal Rights,” advised Petitioner that its facility had a right to contest
the findings of noncompliance that resulted in the imposition of remedies, by filing a
written request within 60 days of receipt of such notices. CMS Exs. 3, 11.5

Where pertinent, 42 C. F. R. § 498.40 provides as follows:

(a) Manner and timing of request. (1) An affected party entitled to a hearing
under § 498.5 may file a request for hearing with CMS .....

* Petitioner has not advanced reasons for failing to appeal the DPNA imposed
pursuant to the August 10, 2005and September 27, 2005 surveys. See CMS Ex. 3.
6

(2) The affected party or its legal representative or other authorized official must
tile the request in writing within 60 days from receipt of the notice . . . unless that
period is extended... .

lhe inference that | draw from the cited portion of the notice letter, and the regulatory
language regarding Petitioner's appeal rights, is that it did not read the information
carefully enough. The notice letter of sanction unequivocally makes reference to the
specific section of the regulation that establishes that Petitioner has 60 days from the
receipt of the notice to appeal the agency action. Had Petitioner read the regulation and
counted 60 days from April 3, 2006, it would not have filed the request for hearing on
June 8, 2006.

Petitioner has to show that it was prevented from filing a timely request for hearing due to
circumstances beyond its control. Hospicio San Martin, supra, at 2. Petitioner has not
come forward with a persuasive argument as to why it did not follow the admonition in
the notice letters regarding its right to a hearing. It was within Petitioner's control to read
and count 60 days from the date of reccipt of the notices; but it cither failed to do so, or
ignored the regulatory dircctive. Instead of coming forward with an explanation for not
paying attention to the language of the regulation, Petitioner centers attention on the
alleged misinformation provided to its administrator by a CMS official. That
misinformation, it argues, is the circumstance that made it file untimely. | disagree.

n her affidavit, Ms. Marianne Wiesen states that during a telephone conference that took
place on April 17, 2006, Ms. Ellen Greif, a CMS representative, told her that the facility
had until June 10, 2006, to request a hearing. P. Ex. |. She adds that had she been
informed of a prior filing date, she would have filed the request prior to June 6, 2006. In
other words, there were no circumstances other than the alleged erroneous information
received from CMS that resulted in the late submission of a request for hearing. Thus, |
find that nothing prevented Petitioner from filing a timely request for hearing.

Nothing that CMS’s representative may have told Petitioner regarding the appeal deadline
could have the effect of relieving it of the responsibility to act according to the April 3,
2006-notice letter. That notice unequivocally told Petitioner that a request for hearing
had to be filed in conformity with the procedures set out in section 498.40. Those
procedures require the filing of a request for hearing within 60 days of receipt of the
notice of sanctions. Thus, even if Petitioner was told that an appeal did not have to be
filed until June 10, 2006, it had no reasonable basis to rely on that to the detriment of
what it had already been told in the notice.

Furthermore, Petitioner did not file an untimely pro se request for hearing through the
facility administrator. It was filed by the facility’s legal representative. CMS Ex. 12, at
2. Consequently, it was Petitioner’s attorney who relied on a third hand conversation

7

between Ms. Wiesen and Ms. Greif, rather than comply with the duty to carefully read the
notice and apply the regulatory requirements. In fact, the record reflects that as early as
December 29, 2005, Petitioner’s legal counsel was involved in the survey events and was
communicating with the state survey agency. See CMS Ex. 12, at 3-4. It is unacceptable
tor that legal counsel to claim now that Petitioner filed an untimely request for hearing
because the facility administrator was given incorrect information as to when that request
was due.

As to the October 5, 2005-notice of imposition of remedies, Petitioner has not refuted
CMS’s showing that appeal of the DPNA sanction was not filed until approximately six
months after the expiration of the time permitted by the regulations.

Finally, whereas | am empowered to decide legal and factual issues, I cannot provide
equitable relief.

V. Conclusion

Based on the applicable law and undisputed facts, | conclude that Petitioner’s hearing
request was untimely filed, and good cause does not exist to extend the time for filing.
CMS’s motion to dismiss is granted.

/s/

Jose A. Anglada
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)

Perry Green Valley, ) Date: April 18, 2007
(CCN: 37-5373) )
)
Petitioner, )
)

“Vie ) Docket No. C-06-380

) Decision No. CR1587
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, Perry Green Valley (Petitioner or facility), is a long-term care facility located
in Perry, Oklahoma and certified to participate in the Medicare program as a provider of
services. Here, Petitioner appeals the Center for Medicare and Medicaid Services’
(CMS’s) determinations that, from September 7 through 29, 2005, it was not in
substantial compliance with Medicare program requirements, including 42 C.F.R.

§ 483.25(h)(2), and that, on September 7, 2005, its conditions posed immediate jeopardy
to resident health and safety. The parties have agreed that this matter may be decided on
the written record, without an in-person hearing. For the reasons set forth below, I find
that the facility was not in substantial compliance for the period in question, and that, on
September 7, 2005, its deficiencies posed immediate jeopardy to resident health and
safety. I also sustain the $4,150 penalty imposed.
I. Background

Following a survey completed September 8, 2005, surveyors from the Oklahoma State
Department of Health (State Agency) concluded that the facility was not in substantial
compliance with federal requirements for nursing homes participating in the Medicare
program. Specifically, they found that the facility did not meet federal requirements
under:

. 42 CFR. § 483.25(h)(2) (Tag F-324 — Quality of Care: Failure to Prevent
Accidents) at a “J” level of scope and severity (isolated instance of immediate
jeopardy to resident health and safety);

. 42 C.F.R. § 483.20(b)(2)(ii) (Tag F-274 — Resident Assessment) at a “D” level of
scope and severity (isolated deficiency that caused no actual harm with the
potential for more than minimal harm);

. 42 C.F.R. §§ 483.20(d) and 483.20(k)(1) (Tag F-279 — Comprehensive Care
Plans) at scope and severity level “D”;

7 42 C.F.R. § 483.25(d) (Tag F-315 — Quality of Care: Urinary Incontinence) at an
“E” level of scope and severity (pattern of noncompliance that caused no actual
harm with the potential for more than minimal harm);

. 42 C.F.R. § 483.35(i)(2) (Tag F-371 — Dietary Services: Sanitary Conditions) at
scope and severity level “E”;' and

. 42 C.F.R. § 483.60(a) (Tag F-426 — Pharmacy Services: Procedures) at scope and
severity level “D.”

CMS Ex. 4; P. Ex. 31.

' Although neither party mentions it, the statement of deficiencies incorrectly cites 42
C.F.R. § 483.35(h)(2) for deficiencies that instead violate § 483.25(i)(2). CMS Ex. 3, at
25. Nevertheless, the survey report quotes the text of the correct sub-section, and lays out
in sufficient detail the bases for its findings. Jd. at 25-26. I consider this sufficient notice
of violations. Cedar View Good Samaritan, DAB No. 1897, at 7-9 (2003) (quoting the
text of the regulation held sufficient notice of violations, without actual citation to the
regulation). Moreover, as discussed below, the deficiencies cited under 42 C.F.R.

§ 483.25, by themselves, justify the penalties imposed, without considering the
deficiencies cited under dietary services.
3

CMS agreed with the surveyors’ conclusions, and has imposed a Civil Money Penalty
(CMP) of $3,500 for the one day of immediate jeopardy (September 7), plus $50 per day
from September 8 through 29, 2005, for a total CMP of $4,150. P. Ex. 21.

Petitioner timely appealed and the matter was assigned to me as Docket No. C-06-12. In
that case, I issued an initial order on October 19, 2005, directing CMS to file its
prehearing exchanges on or before February 21, 2006. Unfortunately, the attorney who
was then representing CMS, Mr. Kermit Williams, simply ignored my order. CMS filed
no submission and no request for an extension of time in which to file. In an email sent
March 8, 2006, we directed the parties to provide a status report no later than close of
business that day. Petitioner promptly responded; CMS did not. In an Order to Show
Cause dated March 10, 2006, I directed CMS to show cause why, in light of CMS’s
failure to proceed, I should not remand the matter to CMS. On March 21, 2006, Mr.
Williams finally responded, indicating that he was not prepared to comply with my order
and asking for additional time. I considered this response inadequate, and, on March 22,
2006, remanded the case to CMS to determine whether it was interested in pursuing the
matter.

On March 31, 2006, CMS issued a new initial determination, which Petitioner again
appealed. The case was then reassigned to me as Docket No. C-06-380. The parties filed
their initial briefs (CMS Pre-hearing Br. and P. Pre-hearing Br.) and submissions.
Petitioner also moved for summary judgment, which CMS opposed, suggesting (without
filing its own motion) that CMS was instead entitled to summary judgment. In a ruling
dated August 24, 2006, I denied summary judgment. Although the parties agreed that one
of the facility residents (R4) was at significant risk for falls, that she had suffered multiple
falls and some injuries, and that the facility had taken some steps to prevent falls and
injury, they disputed the adequacy of the facility’s actions. Under the Departmental
Appeals Board’s reasoning in Lebanon Nursing and Rehabilitation Center, DAB No.
1918 (2004), summary judgment is generally not appropriate where the parties dispute the
degree of resident risk or the appropriateness of a facility’s plan to address that risk.

The parties subsequently agreed that the case could be decided on their written
submissions, without an in-person hearing. See Agreed Motion to Supplement Testimony
(September 11, 2006); Amended Order and Schedule for Briefing (September 11, 2006);
42 C.F.R. § 498.66 (waiver of right to appear and present evidence). The parties have
filed closing briefs (CMS Br. and P. Br.) and reply briefs (CMS Reply and P. Reply).
CMS has filed 14 exhibits (CMS Exs. 1-14). Petitioner has filed 32 exhibits (P. Exs. 1-
32).? In the absence of any objection, I admit CMS Exs. 1-14 and P. Exs. 1-32.

> P. Exhibit (Ex.) 1 consists of six sub-parts, Exs. la through If.
II. Issues
This case presents the following questions:

. Whether from September 7 through 29, 2005, the facility was in substantial
compliance with requirements for facilities participating in the Medicare
program. I consider specifically the facility’s compliance with 42 C.F.R.

§ 483.25(h)(2).3

. If the facility was not in substantial compliance on September 7, 2005, did
its conditions pose immediate jeopardy to resident health and safety?

. Since CMS has imposed the statutory minimum penalty amounts ($3,050
for one day of immediate jeopardy, and $50 per day for each day of
substantial noncompliance), the question of whether those penalties
imposed are reasonable is not before me. See, e.g. Hermina Traeye
Memorial Nursing Home, DAB No. 1810, at 16 (2002). Nor do I consider
the duration of the $50.00 per day CMP, since Petitioner has not raised that
issue.*

> Although CMS cited additional deficiencies, the parties have focused exclusively on the
immediate jeopardy finding, 42 C.F.R. § 483.25(h)(2). Inasmuch as this deficiency, by
itself, justifies the penalties imposed, I need not review the remaining citations. Batavia
Nursing and Convalescent Center, DAB No. 1904, at 23 (2004); Beechwood Sanitarium,
DAB No. 1824, at 19 (2002).

* In an event, where (as here) the facility’s deficiencies have the potential for more than
minimal harm, the facility is generally considered out of compliance “from the date of the
completion of the survey in which these deficiencies were cited until the date of the
resurvey in which substantial compliance is established.” Lake City Extended Care, DAB
No. 1658, at 14-15 (1998). And the burden is on the facility to prove that it has resumed
complying with program requirements, not on CMS to prove that the deficiencies
continued to exist after they were discovered. Hermina Traeye Memorial Nursing Home,
DAB No. 1810, at 10 (2002).
III. Discussion

A, The facility did not provide Resident 4 (R4) with adequate
supervision to prevent accidents and was therefore not in
substantial compliance with the program participation
requirement set forth at 42 C.F.R. § 483.25(h)(2).

Under the statute and “quality of care” regulation, each resident must receive and the
facility must provide the necessary care and services to attain or maintain the highest
practicable physical, mental, and psychological well-being, in accordance with the
resident’s comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R.

§ 483.25. The regulation imposes on facilities an affirmative duty designed to achieve
favorable outcomes “to the highest practicable degree.” Windsor Health Care Center,
DAB No. 1902, at 16 - 17 (2003); Woodstock Care Center, DAB No. 1726, at 25 - 30
(2002). Among other specific requirements, the facility is required to “take reasonable
steps to ensure that a resident receives supervision and assistance devices designed to
meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents.”
42 C.F.R. § 483.25(h)(2); Windsor, DAB No. 1902, at 5 (2003); Asbury Center at
Johnson City, DAB No. 1815, at 12 (2002); Koester Pavilion, DAB No. 1750, at 25 - 26
(2000); Woodstock, DAB No. 1726, at 25 (2002). The regulation requires the facility to
anticipate what accidents might befall a resident and to take steps — increased supervision
or the use of assistance devices — to prevent them. Guardian Health Care Center, DAB
No. 1943, at 18 (2004).

A facility is permitted the flexibility to choose the methods it
uses to prevent accidents, but the chosen methods must
constitute an “adequate” level of supervision under all the
circumstances.

Windsor, DAB No. 1902, at 5 (2003).

In this case, R4 was a 55-year-old woman with diagnoses of malignant brain cancer,
obsessive-compulsive disorder, and dementia. She suffered significant long and short-
term memory loss. ““Verbal reminders seem to fall on deaf ears at times.” CMS Ex. 7, at
6. She was unable to walk and required total assistance with all transfers. She spent her
days up in a wheelchair, wandering the halls, asking for cigarettes and Pepsi. Id.

R4 was admitted to the facility on May 4, 2004. She was at high risk for falls, and, to
prevent accidents, the facility provided her with a Wanderguard bracelet, as well as bed
and chair alarms, and kept her mattress at a low level. P. Ex. le, at 1-5. However, as the
record shows, these interventions were not particularly effective in preventing accidents.
6

On May 6, 2004, at 4:15 a.m., an aide responded to the sound of R4’s bed/chair
alarm, and found her lying on the floor of her room. R4 said that she “sat up on
the side of bed and tried to stand up and ended up on the floor.” No additional
precautions seem to have been taken to prevent recurrence, except “frequent bed
checks” and to continue with the bed alarm and low bed.

. Ib, at 2; P. Ex. 17, at 2.

On May 17, 2004, a nurse observed R4’s attempt to enter her room. R4 was
unable to get her wheelchair over the threshold and fell forward out of the chair.
Initially, no injuries were reported, although a subsequent entry in the nursing
notes mentions a red hematoma on her right forearm. Staff apparently took no
action to prevent a recurrence except to remind R4 to ask for assistance if she
needed it.

. Ib, at 3; P. Ex. 17, at 3.

On May 23, 2004, at 3:15 p.m., R4 (who was incontinent and required diapers)
“was found” on the floor near the toilet in the Hall 6 bathroom. She said that she
fell trying to sit on the toilet. Again, no steps were taken to prevent recurrence
except to instruct R4 to ask staff for assistance.

. lb, at 4; P. Ex. 17, at 4.

But on May 26 at 11:30 a.m., a nurse again found R4 on the bathroom floor in
front of the toilet. Her wheelchair alarm was turned on but was not going off.
Staff replaced the batteries in her chair alarm, and reminded her to ask for
assistance.

. 1b, at 5; P. Ex. 17, at 6.

At 2:45 p.m. the same day, a nurse found R4 sitting on the floor at the side of her
bed. The nurse reminded R4 to use her call light, and the resident agreed to do so.
Either no incident report was generated following this incident, or Petitioner
decided not to produce it.

. 1b, at 5.
P. Ex.

7

On May 31, 2004, at 9:30 p.m., a nurse aide found R4 sitting on the floor facing
her bed. She told the aide that she had needed to go to the bathroom. The
facility’s response was to remind the resident to leave her alarms on, and to call for
help. Staff also placed a mat beside her bed.

1b, at 6; P. Ex. 17, at 7.

On June 19, 2004, R4 was in the dining room, attempting to wheel her wheelchair
away from the table, when she “scooted out” of the wheel chair. According to the
incident report, a pressure sensitive chair matt was ordered for R4’s wheelchair.
Subsequent notes refer to the incident as a “fall.”

. 1b, at 7; P. Ex. 17, at 8.

On July 4, 2004, R4 was again “found on floor,” with the chair alarm beeping.
She said that she had slipped. Again, Petitioner provides no evidence that an
incident report was generated following the July 4, 2005 incident.

. 1b, at 8.

An incident report indicates that at 9:00 p.m. on July 14, 2004, R4 went into her
room and shut the door. The alarm sounded. When the nurse arrived and found
her on the floor, she said that she had slipped. Nurses notes do not mention the
incident.

. 17, at 10; See P. Ex. 1b, at 34.

On July 25, 2004, at 10:20 a.m., R4 was found outside her bathroom, sitting on the
floor in front of her wheelchair with her feet extended in front of her. She said that
she tried to go to the bathroom. Again, the facility responded by encouraging her
to ask for assistance in transferring. The CNA was also encouraged to toilet R4
every two hours and as needed.

. lb, at 8; P. Ex. 17, at 9.

On August 15, 2004, at 2:30 p.m. a nurse found R4 lying on her back on the floor
of her room. She said that she had attempted to put herself to bed and fell. To
prevent recurrence, the incident report mentions bed/chair alarms, and wheelchair
8

pad, and suggests offering to lay her down before a shift change. The following
day, R4 attempted to rise from her chair, the alarm went off, but a nurse caught
her.

. 1b, at 9; P. Ex. 17, at 12.

On August 27, 2004, however, at 9:05 a.m., R4 was again found in a bathroom on
Hall 3, wedged between the toilet and the wall; she was sitting up with her back
against the wall and legs out in front of her. She said that she was just trying to get
to the bathroom. The chair alarm is described as in place and working properly.
R4 was reminded to call for assistance, but “is very forgetful.” According to the
incident report, staff was also encouraged to monitor her frequently.

. Ib, at 10; P. Ex. 17, at 11.

On September 3, 2004, at 6:45 p.m., R4 again attempted to put herself from
wheelchair to bed, and fell on the floor. She apparently suffered scratches down
her back. To prevent recurrence, the incident report says “assist to bed quickly
when she asks” and refers to the wheelchair pad.

. 1b, at 11; P. Ex. 17, at 14.

On October 5, 2004, R4 was found sitting on the floor. Staff again instructed her
to use the call system.

. lb, at 11; P. Ex. 17, at 15.

On October 7, 2004, at 10:45 a.m., a housekeeper found R4 sitting on the floor in
front of her bed, her feet out in front of her. The chair alarm was sounding “upon
entering the room.” R4 said that she slid off the bed trying to “a” herself. Again,
she was encouraged to call for assistance, but “is very forgetful.” Staff were again
encouraged to check her frequently.

. Ib, at 12; P. Ex. 17, at 16.

On October 16, 2004, at 9:20 a.m., an aide found R4 lying on the floor by the head
of her bed. She was lying on her left side with a large body pillow under her
armpit and was reading a book. She said that she had tried to get up and go to bed.
Staff again write that her chair alarm is in place and working, that the resident is
encouraged to call for assistance, and that staff is encouraged to monitor her
frequently.
las)

P. Ex.

. Ex.

1b, at 13-14; P. Ex. 17, at 17.

On November 18, 2004, at 10:00 p.m., R4 was found on the floor in the smoking
room.

. 1b, at 15; P. Ex. 17, at 18.

On December 2, 2004, R4 was found sitting on the floor in front of her wheelchair,
next to her bed. Her feet were folded under her. She said that she had been trying
to get out of bed. The facility’s response was to encourage her to use the call light
for assistance and encourage staff to check her more frequently.

. lb, at 16, P. Ex. 17, at 19.

On December 28, 2004, at 9:55 a.m., the resident was escorted out to the patio to
smoke a cigarette. She was apparently left there, because five minutes later, she
“was found” lying on her left side, with “bright red bleeding” from her left nostril.
She had abrasions on the right side of her face and around her right eye. She had
abrasions on her left elbow and knee. She was unable to say how she fell, but
another resident said that she leaned forward and fell from the wheelchair,
scraping the right side of her face and hitting her nose on the ground. Remarkably,
given the seriousness of this accident, the facility either failed to generate an
incident report or Petitioner decided not to produce it.

. 1b, at 17.

On February 14, 2005, at 1:30 p.m., R4 was found on the floor in front of her
wheelchair. She said that she tried to get into bed and fell. In response, the
incident report indicates that the CNAs should lay her down for a nap after lunch.

. 1b, at 18; P. Ex. 17, at 20.

A February 24, 2005 nursing assessment notes R4’s unsteady gait, inability to ask
for assistance in transferring, and history of frequent falls. The assessment notes
that her brain cancer affects her memory and her ability to understand.

1b, at 19.
P. Ex.

10

On March 3, 2005, at 6:00 p.m., R4 was again found on the floor of her room; she
reported that she had “‘scooted out” of her wheelchair. The incident report
indicates that the resident should lie down for a nap mid-afternoon.

. 1b, at 19; CMS Ex. 8, at 1; P. Ex. 17, at 21; CMS Ex. 9, at 1.

A March 18, 2005 nursing assessment again notes R4’s history of falls, and use of
a chair alarm for safety, but says nothing more about the effectiveness (or lack
thereof) of these interventions.

. Ib, at 20.

On April 4, 2005, at 6:15 p.m., R4 was again found on the floor of the Hall 3
bathroom, wedged between the wall and the toilet. She said that she had been
trying to use the bathroom. Staff assisted her back into her wheelchair and
encouraged her not to attempt to get out of it without assistance, but the nurse
notes “unsure if she understood.”

. 1b, at 20; CMS Ex. 8, at 2; P. Ex. 17, at 22; CMS Ex. 9, at 2.

At 11:00 a.m. on April 10, 2005, R4 was reaching for something on the floor, and
“toppled” onto the floor. She hit the side of her right eye on the bedside table, and
the area was “blue in color.” The incident report acknowledges that because of her
cognitive impairment, R4 does not remember verbal cautioning.

1b, at 21, 22 (small purple bruise to right eye); CMS Ex. 8, at 3; P. Ex. 17, at 23;

CMS Ex. 9, at 3.

P. Ex.

On April 19, 2005, at 1:35 p.m. she was found lying on the floor, face down on her
right side. Her nose was bleeding; she had a bruise and bump on the left side of
her forehead. She said that she had been reaching forward to reach a book on her
bedside table, and had fallen forward, hitting her head. A bruise subsequently
appeared on her left forearm, and she complained of pain. Again, the incident
report says that she is encouraged to call for assistance. Staff were also
encouraged to leave items within her reach.

1b, at 22, 23; CMS Ex. 8, at 4, 5; P. Ex. 17, at 24; CMS Ex. 9, at 4.
P. Ex.

P. Ex.

P. Ex.

11

A nursing entry dated April 20, 2005, notes that staff are “encouraged” to
anticipate and meet her needs to prevent a recurrence.

1b, at 23.

But at 6:15 a.m. on April 25, 2005, a nurse aide found R4 lying on the floor on her
left side “with a large (one foot in diameter) pool of blood from her nose on the
floor, coagulated blood streaming from both [nostrils].” The nursing entry
indicates that she was unable to explain what happened, but had been in her
wheelchair prior to the fall. She was taken to the emergency room via ambulance.
She returned at 9:00 a.m., her face bruised and swollen. The incident report
suggests no new interventions to prevent recurrence (“keep bed/chair alarm on
resident [at] all times”), but nursing notes indicate that her family asked that she be
given a safety belt to prevent falls, and staff suggested a lap buddy. Her physician
ordered a lap buddy on April 25, 2005.5

. 1b, at 23, 24; CMS Ex. 7, at 5; CMS Ex. 8, at 5, 6; P. Ex. 17, at 25; CMS Ex. 9, at

But at 7:30 - 7:45 p.m. on April 26, 2005, she was again “found” on the floor of
her room. She said that she “just fell/slid out of my chair.” The incident report
indicates that a lap buddy had been ordered.

1b, at 25; CMS Ex. 8, at 7; P. Ex. 17, at 26; CMS Ex. 9, at 6.

At 7:00 a.m. the following morning, R4 was wheeling herself into the dining room
for breakfast when she fell forward out of her wheelchair, hitting her right
forehead to the floor. A mechanical lift was used to return her to her wheelchair.
She suffered a bloody nose and additional bruising to her face. According to a
CNA witness, she had been leaning forward in the chair at the time of the fall.
Nursing notes report that during the afternoon R4 became lethargic and her right
pupil was “sluggish.” Upon examination, she was minimally responsive. She was
eventually taken to the emergency room by ambulance.

1b, at 25-27; CMS Ex. 8, at 7-9; P. Ex. 17, at 26-27; CMS Ex. 9, at 7.

* A lap buddy is a laptop cushion that should fit snugly between the resident and the
wheelchair frame to facilitate upper body positioning and reduce falls. CMS suggests that
R4’s lap buddy did not fit snugly; it was too small for the chair.
12

. When she returned to the facility that day, staff put a “landing strip” next to her
bed, and instructed her not to get out of bed “for any reason” unless staff is there to

help.
P. Ex. 1b, at 28.
. On May 1, 2005, at 6:00 a.m., R4 was found on the floor of her room, abrasions on

both knees. She said that she had been leaning forward when she fell. An
incident report describing the accident says that she is in a low bed with a safety
mattress on the floor, and that she uses a lap buddy. A 1:00 p.m. note says “lap
buddy in place when in [wheelchair],” although I don’t know if this means it was
in place prior to her fall, or was subsequently put in place.

P. Ex. 1b, at 30; CMS Ex. 8, at 12; P. Ex. 17, at 30; CMS Ex. 9, at 10.

. In a separate incident, at 8:00 p.m. the same day, the CNA again found R4 on the
floor of her room. The nursing notes and incident report are not wholly consistent
as to the circumstances of this incident. The nursing note says that the nurse
instructed her to leave the lap buddy on at all times, and told the CNA to lay her
down immediately after dinner, suggesting that she fell from her chair. But the
incident report indicates that she “slid out” of bed. It also indicates that she was in
a low bed, with a safety mattress on the floor.

Compare P. Ex. 1b, at 30 with P. Ex. 17, at 28. Notes thereafter include complaints of
headache and facial pain from her bruises. See P. Ex. 1b, at 31.

. At 9:30 p.m. on May 2, 2005, the nurse was called to the resident’s room where R4
was lying on the mat on the floor, a bleeding abrasion on her forehead. The

incident report indicates that she rolled out of bed onto the safety
mat, and that her mattress is in a low position.

P. Ex. 1b, at 31; P. Ex. 17, at 29.

. A May 4, 2005 entry indicates that R4 removed the lap buddy four times on that
shift, and “is able to remove [it] herself.” She was encouraged to leave it in place.

P. Ex. 1b, at 32.
13

. An assessment dated May 5, 2005, reports R4’s increased incidence of falls, and
notes that, even though a lap buddy was put on her chair, she is able to remove it
and continues to fall. Staff were still to keep her bed low with a safety mattress on
the floor; remind her to use her call light; evaluate causes of falls; gather and
assess information on her falls.

CMS Ex. 7, at 6-9.

. On July 21, 2005, a CNA found R4 on the floor in her room. She had removed the
lap buddy, tried to get up, but fell. She said that she had wanted to get into bed.
She also complained that she hurt “all over,” but a head-to-toe assessment found
no injuries. The facility’s response was to encourage her to use her call light, to
request assistance, and not to remove the lap buddy herself.

P. Ex. 1b, at 34; P. Ex. 17, at 31.

. Finally, at 7:00 p.m. (per nursing notes) or 7:30 p.m. (per incident report) on
September 1, 2005, R4 was found on the floor of her room with the lap buddy
underneath her. She said that she was trying to get up and into bed. One nurse
writes that “this lady should be put to bed by 7:00 p.m. as she is up all day [and] is
ready by that time.° This might avoid incidents of this nature.” But under steps
taken to prevent recurrence, the facility’s response, once more, is “instructed
resident to not remove lap buddy [and] use call light when needing assist[ance].”

P. Ex. 1b, at 36; P. Ex. 17, at 32.

Overwhelming evidence thus establishes that, from the time of R4’s admission, her high
risk of injury from falls was plainly foreseeable. To establish its substantial compliance
with § 483.25(h)(2), the facility must show that it took “reasonable steps to ensure” that
she receive the level of supervision and assistive devices she needed in order to be safe.

Petitioner acknowledges R4’s propensity to fall, attributes it to her deteriorating
condition, and argues that it “successfully implemented interventions after each fall that
reduced the likelihood of that particular type of fall recurring.” P. Br. at 1-2. But the
evidence before me does not establish that the facility was adequately responding to R4’s
alarming rate of accidents. In fact, after implementing its initial efforts (bed/chair alarms
and low level mattress) — which did not effectively prevent accidents — about the only

° That R4 was “up all day” suggests that staff did not “lay her down before shift change”
(P. Ex. 17, at 12) and did not “lay her down for a nap after lunch” (P. Ex. 17, at 20) as
recommended in the earlier incident reports.
14

additional step the facility took was to provide R4 a lap buddy. It did so at the family’s
request sometime in April 2005, after almost a full year of R4’s experiencing frequent
and dangerous accidents. P. Ex. 1b, at 23; P. Ex. 17, at 25, 26. But the lap buddy was
plainly ineffective since R4 was able to remove it, and, in fact, she removed it repeatedly.
P. Ex. 1b, at 32, 34, 36; CMS Ex. 7, at 6, 7. The two falls that most immediately
preceded the survey (July 21 and September 1, 2005) involved her removing the lap
buddy. P. Ex. 1b, at 34, 36.

The incident reports mention a number of other potential interventions: “frequent bed
checks” (P. Ex. 17, at 2); “encourage CNA to toilet every 2 hrs. and as needed” (P. Ex.
17, at 9); “lay her down before shift change” (P. Ex. 17, at 12); “lay her down for a nap
after lunch” (P. Ex. 17, at 20); “encourage staff to monitor frequently” (P. Ex. 17, at 11,
16, 17, 19); “staff encouraged to leave items w/in her reach” (P. Ex. 17, at 24); staff
“encouraged to anticipate and meet her needs” (P. Ex. 1b, at 23); “this lady should be put
to bed by 7:00 p.m.” (P. Ex. 1b, at 36). But not one shred of evidence suggests that the
facility ever implemented any of these suggestions in any systematic, reliable way. I see
no evidence that these interventions were incorporated into R4’s care plan. CMS Ex. 7, at
8. Petitioner does not even define “frequent” checks, much less offer evidence that staff
was monitoring R4 at regular intervals.

Most often, the facility responded to R4’s accidents by “reminding” or “encouraging” her
to ask for assistance. P. Ex. 17, at 3, 4, 6, 7, 14, 15, 16, 17, 19, 22, 24, 31,32. But, as
facility staff well understood, this response was useless. R4 simply could not remember
such cautions. See, e.g., CMS Ex. 7, at 6, 7; P. Ex. 1b, at 19, 20, 23 (because of her
cognitive impairment, does not remember verbal cautioning).

Petitioner’s expert witness, former nurse surveyor Linda Wilkerson, claims that the
facility took some additional intervening steps to prevent accidents because staff took
R4’s blood pressure every week; and periodically checked her medication levels. P. Ex.
32, at 2, 9-10. I do not see a lot of evidence linking these practices to accident
prevention, although that may be attributable to the absence of specific citations to the
clinical records in Petitioner’s argument.’ R4’s blood pressure was normal, and nothing
in the record suggests that her propensity to fall was related to either blood pressure or
medication issues. According to her assessments, she was at risk because she was unable
to walk or transfer without total assistance. CMS Ex. 7, at 6. But she could not
remember that she was unable to walk; she also tended to lean too far forward in her

7 Throughout their briefs, both parties make many broad assertions without specific
reference to the record, which makes it much more difficult to credit their arguments.
15

wheelchair and fell out. In any event, even assuming that it was necessary to eliminate
blood pressure and medication as factors contributing to R4’s risk, doing so did not
substitute for providing her adequate supervision and assistive devices to prevent
accidents.

Nurse Wilkerson also points to the bed and chair alarms as devices that allow for staff's
“rapid response,” so they can intervene quickly and prevent further injury. P. Ex. 32, at 4.
Bed and chair alarms can do that, and, the record here includes one occasion where
responding to an alarm likely prevented an accident. P. Ex. 1b, at 9. More often,
however, staff either did not hear an alarm, or were unable or unwilling to respond
quickly enough to prevent accidents. A bed or chair alarm is not an adequate substitute
for supervision, and the record is striking for how often R4 is “found” lying on the floor.
P. Ex. Ib, at 2, 4, 5, 6, 8, 9, 10, 11, 12, 13-14, 15, 16, 17, 18, 19, 20, 22, 23, 25-27, 30, 31,
34, 36; P. Ex. 17, at 10.

Pointing to an entry in the nurses’ notes, Nurse Wilkerson also claims that the facility
moved R4 to a room nearer the nurses’ station. P. Ex. 32, at 8; P. Br. at 5. A May 6,
2005 entry says that, after a discussion with R4’s mother, the facility intended to move R4
from Room 34 to Room 12, a room “closer to the center of the building.” P. Ex. 1b, at
33. As with so many of the facility’s purported interventions, however, no evidence
establishes that this was ever implemented. To the contrary, the record entries
consistently show that R4 remained in Room 34. The incident reports put her in Room 34
prior to May 6, 2005, when the entry was written (P. Ex. 17, at 2, 3, 7, 10,12, 14, 15, 16,
17, 19, 23, 24, 25, 26, 28, 29). She was there on May 6, 2005 (P. Ex. 17, at 30), and, she
was still there at the time of her most recent falls, July 21, and September 1, 2005. P. Ex.
17, at 31,32. See also P. Ex. la, at 2 - 10 (medication records throughout her stay show
that she is in Room 34); P. Ex. 1b (from time of her admission through September 20,
2005, virtually every page of the nurses’ notes places her in Room 34).®

Finally, Petitioner complains that the immediate jeopardy penalty was imposed for one
day in September, pointing out that, as of the time of the survey, R4 had fallen only twice
since May (on July 21, 2005 and again on September 1, 2005). Indeed, even though the
facility failed to prevent accidents for a 16-month period, CMS has only imposed a
penalty effective September 7, 2005. Certainly, CMS might have determined that the

5 Facility staff obviously know whether R4’s room was changed, and no staff person has
suggested that it was. That Nurse Wilkerson would make this claim without regard to the
overwhelming evidence to the contrary, suggests that she did not verify her factual
assertions, and raises serious questions about the credibility of her statements and
opinions.
16

facility’s failure to supervise began well before then, and could justifiably have imposed
penalties from an earlier date. However, CMS’s disinclination to do so does not mean
that the facility was in substantial compliance on September 7, 2005. The evidence
establishes on September 7 and thereafter, R4 was at high risk for falls, the facility
recognized that risk, but was not providing her the “necessary care and services to attain
or maintain the highest practicable physical, mental, and psychosocial well-being,” as
required by the regulation.? I must therefore sustain CMS’s determination that the facility
was not in substantial compliance.

B. The facility conditions posed immediate jeopardy to resident health
and safety.

I next consider whether CMS’s immediate jeopardy finding was “clearly erroneous.” 42
C.F.R. § 498.60(c)(2). The Board has observed repeatedly that the “clearly erroneous”
standard imposes on facilities a “heavy burden” to show no immediate jeopardy, and has
sustained determinations of immediate jeopardy where CMS presented evidence “from
which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” Barbourville
Nursing Home, DAB No. 1962, at 11 (2005); Florence Park Care Center, DAB No.
1931, at 27-28 (2004), citing Koester Pavilion, DAB No. 1750 (2000).

Immediate jeopardy exists if the facility’s noncompliance has caused or is likely to cause
“serious injury, harm, impairment or death to a resident.” 42 C.F.R. § 488.301. Here, R4
suffered some serious injuries as a result of falls. P. Ex. 1b, at 17, 22, 23. Her falling —
particularly falling head-first out of her wheelchair — created the likelihood of more
serious injury. CMS’s immediate jeopardy determination is therefore not clearly
erroneous, and must be affirmed.

C. The facility’s per day CMP for the day of noncompliance at the
immediate jeopardy level must be at least $3,050, and the CMP for each
day of noncompliance that is not immediate jeopardy must be at least $50.

The statute and regulations limit my authority to review the amount of the CMP. In
situations such as this, where the deficiencies constitute immediate jeopardy, CMS may
impose a CMP in the range of $3,050 to $10,000 per day. 42 C.F.R. § 488.438. Where a

° Following the survey, the facility initially provided one-on-one supervision, during
which time the resident attempted to remove the lap buddy, but the nurse prevented her
from doing so. P. Ex. 1b, at 36,41. The facility ordered a drop seat for her wheelchair to
discourage her from standing. The lap buddy, bed and chair alarms, were continued. She
was also supposed to lie down after meals. P. Ex. If, at 1; see also, CMS Ex. 5.
17

CMP of $3,050 per day is imposed, the daily amount must be sustained unless the nursing
home establishes that the determination of immediate jeopardy is clearly erroneous.
Hermina Traeye Memorial Nursing Home, DAB No. 1810, at 16 (2002).

With respect to the days of substantial noncompliance that was not immediate jeopardy,
the minimum penalty must be at least $50 per day. 42 C.F.R. § 488.438.

IV. Conclusion

For all of these reasons, I uphold CMS’s determination that, from September 7 through
29, 2005, the facility was not in substantial compliance with program participation
requirements, specifically 42 C.F.R. § 483.25(h)(2), and on September 7, 2005, its
deficiencies posed immediate jeopardy to resident health and safety. I therefore sustain
the $4,150 CMP.

/s/

Carolyn Cozad Hughes
Administrative Law Judge