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

Golden Living Center — Rib Lake
(CCN: 52-5329),

Petitioner,
v.
Centers for Medicare and Medicaid Services.
Docket No. C-11-215
Decision No. CR2698
Date: January 25, 2013
DECISION

Petitioner, Golden Living Center — Rib Lake, was not in substantial compliance with
program participation requirements on November 9, 2010, due to a violation of 42 C.F.R.
§ 483.25.' There is a basis for the imposition of enforcement remedies. A per instance
civil money penalty (PICMP) of $5,500 is a reasonable enforcement remedy.
I. Background
Petitioner is located in Rib Lake, Wisconsin, and participates in Medicare as a skilled
nursing facility (SNF) and the state Medicaid program as a nursing facility (NF). On
November 9, 2010, Petitioner was surveyed by the Wisconsin Department of Health
Services (the state agency) and found not in substantial compliance with program

participation requirements. The Centers for Medicare and Medicaid Services (CMS)
notified Petitioner by letter dated November 16, 2010, that it was imposing the following

' 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.
enforcement remedies: a PICMP of $5,500; a discretionary denial of payment for new
admissions (DPNA) effective December 15, 2010, and termination effective May 9,
2011. CMS also notified Petitioner that its approval to conduct a Nurse Aide Training
and Competency Evaluation Program (NATCEP) would be withdrawn. A revisit survey
determined that Petitioner returned to substantial compliance with program participation
requirements on November 18, 2010, and the DPNA and termination were not
effectuated. Joint Stipulations of Undisputed Facts and Joint Statement of Issues
Presented for Hearing (Jt. Stip.), filed July 19, 2011.

Petitioner requested a hearing before an administrative law judge (ALJ) on January 12,
2011. The case was assigned to me for hearing and decision on January 20, 2011, and an
Acknowledgement and Prehearing Order was issued at my direction. On September 7
and 8, 2011, a hearing was convened in Madison, Wisconsin and a transcript (Tr.) of the
proceedings was prepared. CMS offered CMS exhibits (CMS Exs.) 1 through 13, which
were admitted as evidence. Tr. 23. Petitioner offered Petitioner exhibits (P. Exs.) 1
through 25, 25a, and 26 through 61, which were admitted as evidence. Tr. 25. CMS
called the following witnesses: Surveyor Jacquelyn M. Dalzell, RN and Surveyor
Yvonne M. Breeden, RN. Petitioner called the following witnesses: Joseph Boero, MD,
Petitioner’s Medical Director; Christie Grubbs, RN, Petitioner’s Director of Nursing
(DON) during the survey; Sandra Larson, Petitioner's Executive Director or
Administrator; Diane Hengst, RN; Grace Brehm, RN; and Bradley Robb, Occupational
Therapist. The parties filed post-hearing briefs and post-hearing reply briefs.

IL. Discussion
A. Issues

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

Whether the remedy imposed is reasonable.
B. Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are
found at section 1819 of the Social Security Act (Act) and at 42 C.F.R. Part 483. Section
1819(h)(2) of the Act authorizes the Secretary of Health and Human Services (Secretary)
to impose enforcement remedies against a SNF for failure to comply substantially with
the federal participation requirements established by sections 1819(b), (c), and (d) of the
Act.” The Act requires that the Secretary terminate the Medicare participation of any
SNF that does not return to substantial compliance with participation requirements within
six months of being found not to be in substantial compliance. Act § 1819(h)(2)(C). The
Act also requires that the Secretary deny payment of Medicare benefits for any
beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with
program participation requirements within three months of being found not to be in
substantial compliance — commonly referred to as the mandatory or statutory DPNA. Act
§ 1819(h)(2)(D). The Act grants the Secretary discretionary authority to terminate a
noncompliant SNF’s participation in Medicare, even if, there has been less than 180 days
of noncompliance. The Act also grants the Secretary authority to impose other
enforcement remedies, including a discretionary DPNA, CMPs, appointment of
temporary management, and other remedies such as a directed plan of correction. Act

§ 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies
against a long-term care facility that is not complying substantially with federal
participation requirements. “Substantial compliance means 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 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, subpart B. State survey agencies survey facilities that
participate in Medicare on behalf of CMS to determine whether the facilities are
complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-
.335. The regulations specify the enforcement remedies that CMS may impose if a
facility is not in substantial compliance with Medicare requirements. 42 C.F.R.

§ 488.406.

A CMP that is imposed against a facility on a per day basis will fall into one of two
ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050
per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a
facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R.

§§ 488.438(a)(1)(i), (d)(2). “Jmmediate jeopardy means 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.

> Participation of a NF in Medicaid is governed by section 1919 of the Act. Section
1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply
with their participation requirements established by sections 1919(b), (c), and (d) of the
Act.
§ 488.301 (emphasis in original). The lower range of a CMP, $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). CMS is authorized to impose a
PICMP from $1,000 to $10,000, whether or not immediate jeopardy is identified. 42
C.E.R. § 488.438(a)(2).

Petitioner was notified in this case that it was ineligible to conduct a NATCEP program
for two years. Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs
may only use nurse aides who have completed a training and competency evaluation
program. Sections 1819(e) and 1919(e) of the Act impose upon the states the
requirement to specify what NATCEPs they will approve that meet the requirements that
the Secretary established and a process for reviewing and re-approving those programs
using criteria the Secretary set. Pursuant to sections 1819(f)(2) and 1919(f)(2), the
Secretary was tasked to develop requirements for approval of NATCEPs and the process
for review of those programs. The Secretary promulgated regulations at 42 C.F.R. Part
483, subpart D. Pursuant to 42 C.F.R. § 483.151(b)(2) and (e)(1), a state may not
approve and must withdraw any prior approval of a NATCEP offered by a skilled nursing
or nursing facility that: (1) has been subject to an extended or partial extended survey
under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) has been assessed a
CMP of not less than $5,000; or (3) that has been subject to termination of its
participation agreement, a DPNA, or the appointment of temporary management.
Extended and partial extended surveys are triggered by a finding of “substandard quality
of care” during a standard or abbreviated standard survey and involve evaluating
additional participation requirements. “Substandard quality of care” is identified by the
situation where surveyors identify one or more deficiencies related to participation
requirements established by 42 C.F.R. § 483.13 (Resident Behavior and Facility
Practices), § 483.15 (Quality of Life), or § 483.25 (Quality of Care) that are found to
constitute either immediate jeopardy, a pattern of or widespread actual harm that does not
amount to immediate jeopardy, or a widespread potential for more than minimal harm
that does not amount to immediate jeopardy and there is no actual harm. 42 C.F.R.

§ 488.301.

The Act and regulations make a hearing before an ALJ available to a long-term care
facility against which CMS has determined to impose an enforcement remedy. Act

§§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A facility has a right to
appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R.
§ 488.408(g)(1); 42 C.F.R. §§ 488.330(e), 498.3. However, the choice of remedies 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 determined by CMS if a successful challenge would affect the range of
the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.
42 C.F.R. §§ 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of
noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is
clearly erroneous.” 42 C.F.R. § 498.60(c)(2). Woodstock Care Ctr., DAB No. 1726, at
9, 38 (2000), aff'd, 363 F.3d 583 (6th 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).
ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The hearing before an ALJ is a de novo proceeding. Residence at Salem Woods, DAB
No. 2052 (2006); Cal Turner Extended Care, DAB No. 2030 (2006); Beechwood
Sanitarium, DAB No. 1906 (2004); Emerald Oaks, DAB No. 1800, at 11 (2001);
Anesthesiologists Affiliated, DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991). The
standard of proof or quantum of evidence required is a preponderance of the evidence.
CMS has the burden of coming forward with the evidence and making a prima facie
showing of a basis for imposition of an enforcement remedy. Petitioner bears the burden
of persuasion to show by a preponderance of the evidence that it was in substantial
compliance with participation requirements or any affirmative defense. Batavia Nursing
& Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB
No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x
181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800; Cross Creek Health Care Ctr., DAB
No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997), aff'd, Hillman Rehab. Ctr.
v. U.S., No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).

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

CMS alleges, based upon the survey that ended November 9, 2010, that Petitioner was
not in substantial compliance with program participation requirements due to a violation
of 42 C.F.R. § 483.25 (Tag F323) that posed immediate jeopardy to its residents. The
only enforcement remedy in issue subject to my review is the $5,500 PICMP that CMS
proposes to impose.*

My conclusions of law are set forth in bold text followed by my findings of fact and
analysis. I have carefully considered all the evidence and the arguments of both parties,
although not all may be specifically discussed in this decision. I discuss the credible

> The ineligibility to conduct a NATCEP is by operation of law, triggered in this case by
the PICMP. It is not an enforcement remedy that CMS or the state has delegated
authority to impose and it is not subject to my review for reasonableness.
evidence given the greatest weight in my decision-making.’ I also discuss any evidence
that I find is not credible or worthy of weight. The fact that evidence is not specifically
discussed should not be considered sufficient to rebut the presumption that I considered
all the evidence and assigned such weight or probative value to the credible evidence that
I determined appropriate within my discretion as an ALJ. There is no requirement for me
to discuss the weight given every piece of evidence considered in this case, nor would it
be consistent with notions of judicial economy to do so.

1. Petitioner violated 42 C.F.R. § 483.25 (Tag F323).

2. Petitioner’s violation of 42 C.F.R. § 483.25 (Tag F323) posed a risk
for more than minimal harm.

3. There is a basis for the imposition of an enforcement remedy.

The surveyors allege in the Statement of Deficiencies (SOD) for the survey that ended on
November 9, 2010, that Petitioner violated 42 C.F.R. § 483.25(h) and that the violation
posed immediate jeopardy. CMS Ex. 3. Whether or not the declaration of immediate
jeopardy was clearly erroneous is not an issue in this case as neither the PICMP nor the
loss of NATCEP authority would be affected by a decision that the declaration of
immediate jeopardy was clearly erroneous. The surveyors originally cited examples
related to four of Petitioner’s residents. However, due to informal dispute resolution, the
SOD was revised and CMS proceeds only upon the examples cited in the SOD related to
Residents 2, 3, and 7. Jt. Stip. § 6; CMS Ex. 3, 12; P. Ex. 1-2.

The surveyors allege in the revised SOD that Petitioner did not ensure that its
environment was as free of accident hazards as possible based on examples related to
Residents 2, 3, and 7. The surveyors’ charge specifically regarding Resident 2 that he fell
on December 16, 2009° with injuries and had to be hospitalized; after his return to
Petitioner he had ten more falls; and after each fall Petitioner failed to critically analyze
the falls to identify and evaluate potential hazards and risks to determine if new
interventions to minimize the risk for falls were necessary. Regarding Resident 3, the
surveyors charge that the resident suffered eight falls after being admitted on August 18,

* “Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary 596
(18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Id. at 1625.

> The surveyors’ allegation is in error as the evidence shows that the fall actually
occurred around 6:45 p.m. on December 15, 2009. P. Ex. 19 at 1.
2010; and Petitioner failed to implement new interventions to meet the resident’s needs.
The surveyors’ charge regarding Resident 7 that she had several falls and Petitioner did
not critically analyze the falls to identify and evaluate the potential hazards or risks to
determine whether additional interventions were necessary to minimize the risk for falls
for the resident. CMS Ex. 3 at 2. The example of Resident 2 adequately establishes the
deficiency and it is, therefore, not necessary to discuss the examples of Resident 3 and
Resident 7.

a. Facts Related to Resident 2 — Example 1 in the SOD

It is not disputed that Resident 2 had falls on December 15, 2009, March 13, 2010, May
9, 2010, May 20, 2010, May 24, 2010, July 2, 2010, August 18, 2010, September 1, 2010,
October 18, 2010, and October 21, 2010. The surveyors allege generally that Petitioner
failed to analyze each fall to identify and evaluate potential hazards and risks to
determine if new interventions were necessary to minimize the risk for falls. CMS Ex. 3
at 3-12.

Petitioner’s contemporaneous clinical records for Resident 2 are considered the most
reliable source of information regarding Resident 2’s falls, care plan, and treatment,
except as specifically noted. The importance of complete, thorough, readable, and
understandable clinical documentation cannot be overstated. In this case the survey
occurred within weeks of the resident’s last fall, but the hearing did not occur until eleven
months after the last fall. It is well understood and accepted that the memories of
witnesses fade with the passage of time, therefore, contemporaneous clinical records will
typically be the most reliable evidence. Errors and omissions in clinical records may be
explained by witnesses, but the witness’s direct knowledge and recall will always be
subject to challenge. Witness testimony that is inconsistent with contemporaneous
clinical records will nearly always be viewed with suspicion. Omissions from clinical
records will invariably present the issue of whether the omission was a simple clerical
error or documentation error; or whether the omission is conclusive evidence that a care
or service was not delivered. This case is made more difficult for Petitioner as it is clear
that Petitioner did not keep up-to-date care plans that listed all interventions. Thus, it is
necessary for me, as it was for Petitioner’s staff, to review the entire clinical record to
identify the various interventions in effect at any given time.

Resident 2 was 91 when originally admitted to Petitioner in October 2008. P. Exs. 12,
13. His clinical records list diagnoses including Alzheimer’s disease with dementia and
agitated features, hypertension, depression, gout, aortic valve disorder, occlusion of the
carotid artery without cerebral infarction, arthritis, and renal failure. P. Exs. 12, 13 at 1.
Petitioner stipulated that the resident was at high risk for falls. Tr. 92.
Resident 2’s care plan with the “Original Date” of November 24, 2008,° shows that he
ad a fall resulting in a concussion without loss of consciousness, a nasal fracture, and an
odontid (protuberance of the second cervical vertebra (Tr. 222-23)) fracture. The care
plan placed in evidence by Petitioner is cause for confusion.’ The care plan is prepared
in a way that could cause one to infer that it was originally developed on November 24,
2008, based on the original date listed. However, the care plan lists diagnoses and
interventions that show that the resident had a nasal fracture, concussion, and a cervical
fracture requiring a cervical collar. P. Ex. 13 at 4-5. The clinical records do not show
that Resident 2 actually had the injuries or required the use of a cervical collar at
admission in October 2008 or in November 2008 when the care plan appears to have
been prepared. P. Ex. 16 at 1-2. Nurses’ notes from November 30, 2009 through
December 15, 2009, show that Resident 2 was often agitated, confused, oppositional, and
abusive of staff. But, the nursing notes do not refer to any neck injury, nose injury, or
any requirement for a cervical collar. P. Ex. 17 at 17. Medical records show that
Resident 2 suffered the cervical fracture requiring use of a cervical collar, the nasal
fracture, and the concussion as a result of a fall in Petitioner’s facility on December 15,
2009. P. Exs. 16 at 3; 17 at 19-20; 18; 19 at 1. I infer that the fall care plan placed in
evidence by Petitioner and the printed interventions listed on the plan were adopted after
the December 15, 2009 fall in Petitioner’s facility. The care plan shows that Resident 2
was assessed as at risk for injury due to falls, a fact not disputed by Petitioner. P. Ex. 13,
at 4-5. I infer that the fall risk interventions in effect after the fall on December 15, 2009,
are those mechanically printed on the residents care plan and include the following:

e Resident 2 was to wear a cervical collar at all times;
e Transfers were to be with assist of one as needed;
e Staff was to use a gait belt for all assisted transfers;

® Each page of the Plan of Care form also reflects a date of “July 2008” in a block near
the top center of the form. The relevance of the July 2008 date is unknown but I
conclude it is not important to my decision because each page near the bottom center also
reflects an “Admit Date” of October 10, 2008. P. Ex. 13.

7 Even the resident’s physician, Dr. Joseph Boero, was confused by the dates on the care
plan. Tr. 188-89.

® Petitioner objected to my consideration of the fall on December 15, 2009 as a basis for
the deficiency citation. Tr. 28, 89-90. CMS agreed that the December 15, 2009 fall was
not the basis for the deficiency citation. Tr. 89-90. I do not consider the December 15,
2009 fall as a basis for the deficiency citation.
e Resident 2’s call-light was to be within reach at all times and answered
promptly;

e A bed alarm was to be in place at night;

e Staff was to respond to the call-light promptly as able;

e Staff was to document any falls/injuries and inform the treating physician
and family promptly per facility protocol;

e Falls risk assessment were to be done quarterly and/or as needed;

e The resident was to be assessed for a nursing rehabilitation program if
indicated;

e Therapies were to be as ordered by the physician;

¢ Staff was to ensure the resident’s room was free from clutter to increase
safety with (independent) toileting;

e The resident’s medications were to be assessed for possible adverse
reactions or side effects related to falls and the physician was to be updated
if needed; and

e Grab bars on the bed were to be up when the resident was in bed to assist
his mobility and positioning.

CMS Ex. 5 at 85; P. Ex. 13 at 4-5.
Resident 2’s care plan placed in evidence by Petitioner also specified that:

e He ambulated with limited assistance of one. P. Ex. 13 at 1.
e He was to be monitored for side effects of medication, including unsteady
balance. P. Ex. 13 at 9, 21.

According to a nurse’s note dated December 16, 2009 at 12:16 a.m., Resident 2 fell at
6:45 p.m. on December 15, 2009. Resident 2 fell in the middle of the hall about 10 feet
from his room. The note states that he was not using his walker at the time. The note
also states that Resident 2 had been to see his spouse’s room so that he could find her in
the morning. The resident’s physician ordered that he be transferred to the emergency
room if the family agreed. He was sent to the emergency room at 9:25 p.m. P. Ex. 17 at
19; P. Ex. 19 at 1-4. A nursing note dated December 17, 2009 shows that the resident
returned to Petitioner at 3:45 p.m. on that date. P. Ex. 17 at 20. A January 7, 2010
physician’s note incorrectly states that the fall occurred on December 16, 2009. The note
indicates that Resident 2 fell forward while walking with the help of his walker, which is
also inconsistent with the nurse’s note that shows he was walking without his walker. P.
Ex. 18 at 1. Petitioner’s accident investigation shows that Resident 2 fell at 6:45 p.m. on
December 15, 2009, and records that the resident reported he tripped over his own feet.
The accident investigation recommended as interventions that: the resident be evaluated
by physical and occupational therapy (PT/OT) and receive treatment for activities of
daily living (ADLs), gait, and exercise to maintain independent ambulation with a

10

walker; and the resident was to have a bed alarm on and monitored at bed time and
during the night. The investigation stated that the resident used a wheeled walker but he
forgot it in his wife’s room, but no intervention was recommended in that regard. P. Ex.
19 at 1-4. The bed alarm is listed on Resident 2’s fall care plan but not the PT/OT
evaluation and training to maintain the resident’s walking independently with a walker.
CMS Ex. 5 at 85; P. Ex. 13 at 4-5. However, there is a record of physician orders dated
January 9 and January 11, 2010 for occupational therapy and gait training. P. Ex. 14 at 1.
There is also evidence of a nursing order dated June 25, 2009, that Resident 2 was to
have a bed alarm during hours of sleep with the alarm box at the head of the bed with
checks twice each day. This order was in effect through October 2010. P. Ex. 12 at 2, 5,
8, 11, 14; P. Ex. 15 at 1-7, 12, 14, 16, 18.

From December 17, 2009 to March 13, 2010, Resident 2’s behavior was better due to a
medication change. He would refuse to wear his cervical collar at times. After a brief
period of wheelchair use, he returned to walking independently with his wheeled walker
but there is no evidence of the rescission of the intervention that he was to have the
limited assistance of one for ambulation. P. Exs. 16 at 3-4; 17 at 20-50. Nurse notes
show that on December 19, 2009, his bed alarm sounded three times on one shift. P. Ex.
17 at 21. Resident 2’s wife passed on December 22, 2009 and he attended the funeral but
the nurse notes to March 13, 2010 show that he frequently could not recall her passing or
the funeral. Resident 2’s Minimum Data Set (MDS) with an assessment reference date of
December 24, 2009 after the December 15, 2009 fall, shows that he was severely
impaired cognitively and he had short and long term memory problems. His mental
functioning varied over the course of the day. He was easily distracted and sidetracked.
He was verbally abusive and resisted care. He was assessed as requiring limited
assistance of one person for bed mobility, transfers, walking in his room, walking along
the corridor, locomotion on and off the unit and for toilet use. The MDS does not show
that he had a toileting plan. The MDS shows that his balance while standing was
unsteady and he had an unsteady gait. CMS Ex. 5 at 113-18; P. Ex. 5 at 2-7. A nurse’s
note on December 25, 2009, shows that Resident 2 continued to walk out of his room
without his wheelchair or walker. P. Ex. 17 at 26. A January 13, 2010 Resident
Assessment Protocol (RAP) for falls based on the December 24, 2009 MDS, assessed the
resident at risk for falls based on his diagnoses; because he had a fall in the past 30 to 180
days; he received antidepressant and anti-anxiety medication regularly; and he had
declines in his ADLs and cognition. The RAP noted that Resident 2 was currently in
therapy. Social Services evaluated the resident on January 20, 2010 and assessed him as
being moderately cognitively impaired and not oriented but lucid. P. Ex. 17 at 39. A
Plan of Care form with an “Original Date” of January 15, 2010 for a problem with
incontinence imposed a toileting schedule under which the resident was to be offered
toileting upon arising, before and after meals, at bedtimes, and during nightly rounds. P.
Ex. 13 at 2. Dr. Joseph Boero, Resident 2’s physician and Petitioner’s Medical Director,
testified about the importance of a toileting schedule as an intervention to prevent falls.
Dr. Boero also testified that it was necessary to discontinue the resident’s physical
11

therapy around February 5, 2010, due to his impaired cognition. Tr. 199-203. Nurse
notes from February 24, 2010 show that he was having trouble getting along with his new
roommate, telling him to get out and threatening to kill him. P. Ex. 17 at 47.

A nurse’s note on March 14, 2010 at 1:27 a.m., records that Resident 2 suffered a
witnessed fall at 11:40 p.m. on March 13, 2010. The note indicates that a nurse heard his
alarm sounding and she arrived at the room in time to see him fall with his back to the
door of his room landing on his elbows and right hip, resulting in small skin tears at the
elbows and bruising. P. Ex. 17 at 51. Petitioner’s staff completed a “Change In
Condition Report — Post Fall/Trauma” on March 14, 2010, which is consistent with the
nurse’s note. P. Ex. 19 at 6. Interventions in place at the time of the fall are listed on the
report as: change in footwear; night light; bed/chair alarm; bed in low position; safety
cues, reinforcement, reminder, and call light within easy reach. P. Ex. 19 at 6. Petitioner
placed in evidence a document titled “Change in Condition Report—Post Fall
Investigation Summary Guidelines for Completion.” The guidelines specify that nurses
are to record interventions that were in place at the time of the fall. P. Ex. 56.
Petitioner’s former DON, Christie Grubbs, testified that the policy set forth in P. Ex. 56
was to be followed in the case of every fall. She also testified that the “Change In
Condition Report — Post Fall/Trauma” (P. Ex. 58) is a computer generated form to be
completed for every fall and the form is intended to capture the required information
regarding a fall input by a nurse. Tr. 454-58. Based upon DON Grubbs testimony and
the guidelines for reporting falls, I presume that when checking the list of interventions in
place prior to the fall on the “Change In Condition Report — Post Fall/Trauma”
Petitioner’s nurses complied with Petitioner’s policy and checked all the interventions in
use at the time of a fall when completing the report form. The post fall interventions
recommended by the report for the March 13 fall were to have the resident use different
footwear, to use a night light, use of a bed/chair alarm, place the resident’s bed in the low
position, use safety cues/reinforcement/reminders, and keep the call light in easy reach.
A PT screen was also recommended. The report also noted that the resident was known
to be noncompliant with the plan of care at times and that he suffered from agitation,
severe dementia, and delusions. P. Ex. 19 at 7. The March 13, 2010 fall is not listed as a
problem on Resident 2’s care plan. However, a hand-written entry near the date March
13, 2010, lists the intervention of encouraging the resident to wear shoes or gripper socks
at night. Another hand-written entry with no date near it provides that the bed alarm was
to be on when the resident was in bed to alert staff when he got up. Another entry near
the date March 13, 2010 states that the resident’s pain was to be monitored every shift,
but only for 72 hours. P. Ex. 13 at 4-5. The interventions to use safety
cues/reinforcement/reminders, use of a night light, placing the resident’s bed in the low
position, and use of a chair alarm as recommended by the fall investigation are not
recorded in the care plan. A physician’s note dated March 18, 2010, states that the
resident had both a bed and chair alarm. P. Ex. 16 at 5.

12

During the period between his falls on March 13, 2010 and May 9, 2010, it was noted by
staff that the resident occasionally was hostile to staff and confused about the death of his
wife. P. Ex. 17 at 51-59. A weekly nursing summary on April 4, 2010, noted that the
resident was ambulated to destinations of choice but there was some weakness with
ambulation. P. Ex. 17 at 55. Resident 2s MDS with a reference date of April 4, 2010,
shows that he continued to be assessed as severely cognitively impaired with a short-term
memory deficit. He continued to be easily distracted with his mental functioning varying
over the course of the day. He was assessed as being independent with bed mobility
requiring setup help only. However, transfers, walking in his room, walking in the
corridor and locomotion on the unit required supervision and set up help. Locomotion
off the unit required supervision of one person. He continued to be unsteady while
standing and to have an unsteady gait. P. Ex. 6.

On May 9, 2010, Resident 2 fell at about 6:00 p.m. CMS Ex. 5 at 38-39, 73; P. Ex. 17 at
59. A Certified Nursing Assistant (CNA) assisted Resident 2 to his room and to bed after
the evening meal. A nurse at the nurse’s station, heard a loud noise, went to investigate,
and found the resident in his room on his knees, and right elbow with the right-side of his
head against his bathroom door. His bedside table was overturned. A nickel-sized bruise
was on the resident’s right elbow. P. Ex. 15 at 59; CMS Ex. 5 at 73. The record does not
show that Resident 2’s alarm sounded when he got out of bed. Petitioner’s “Change In
Condition Report — Post Fall/Trauma” dated May 9, 2010, indicates that prior to the fall
the interventions established for Resident 2 included half bedrails, change in footwear,
night light, toileting schedule, assistive device within reach, bed/chair alarm, safety
cues/reinforcement/reminder, and call light within reach. P. Ex. 19 at 8. The nurse that
completed the report recommended the addition of one intervention listed as wheelchair
positioning. P. Ex. 19 at 9. Notes of the review of the accident by the interdisciplinary
team (IDT), which is responsible for care planning for the resident, state that the resident
is known to have significant cognitive impairment; he is known to be noncompliant at
times with the plan of care; his vital signs did not appear to contribute to his fall, but he
‘as agitation, impaired decision making ability, and he lacked safety awareness. The IDT
recommended a therapy screen. Resident 2’s fall care plan placed in evidence by
Petitioner, does not include the interventions to use half bedrails, to use a night light, to
eep his assistive device, presumably his roller walker, within reach, use of a chair alarm,
or use of safety cues/reinforcement/reminder. The care plan also does not address
wheelchair positioning. P. Ex. 13 at 4-5. Indeed, no new interventions were added to
Resident 2’s care plan due to his fall on May 9, 2010 or the IDT’s review of the fall.
Physician’s orders in Resident 2’s clinical record include an order dated May 17, 2010,
for a PT evaluation and treatment to improve strength with ambulation but that order has
a different resident’s name and is marked “wrong chart.” P. Ex. 14 at 2. The nurse’s
note from May 9, 2010 at 10:39 p.m. shows that the nurse placed the resident’s roller
walker next to his bed and she checked to ensure that his bed alarm was in place. P.

Ex. 17 at 59.

13

On May 20, 2010, Resident 2 fell twice. The first fall is reflected in a nurse’s note dated
May 20, 2010 at 1:43 p.m. The note states that Resident 2 had been confused much of
the shift stating that he left his wife with his brother-in-law who was going to die that
afternoon. He used his wheelchair to go to lunch and after lunch he was placed in the
chair in his room with the alarm set. He was subsequently found walking in the hall with
his walker. The nurse’s note does not mention whether or not the chair alarm was
sounding. Resident 2 lost his balance while walking near the nurses’ station and fell on
his buttocks. The records do not state whether or not staff was assisting Resident 2 while
he was walking with the walker. The nurse’s note states that the floor was dry and the
resident was wearing appropriate footwear. P. Ex. 17 at 62; CMS Ex. 5 at 76. Unlike the
other falls discussed here, Petitioner has produced no report of an investigation or IDT
review of this fall.

The second fall on May 20, 2010 is described by a nurse’s note dated May 20, 2010 at
10:38 p.m. At around 5:50 pm, the nurse and CNA heard a call for help and an alarm
sounding. They found Resident 2 sitting on the floor at the end of his bed with his back
leaning against the bed. His walker was tipped over and his shoes were on. He stated
that he was going to put the tissue box that was lying on the floor in the waste basket. He
was returned to bed with a sling lift. His bed was noted to be in the low position with the
bed alarm active. P. Ex. 17 at 63; CMS Ex. 5 at 77. The “Change In Condition Report —
Post Fall/Trauma” form dated May 20, 2010 lists the following interventions in use prior
to the fall: the night light; assistive device within reach; bed/chair alarm; pain
assessment; bed in low position; physical therapy; safety cues/reinforcement/reminder;
and call light within reach. The report does not show that half bed rails, appropriate
footwear, or a toileting schedule were in use as they were reported to be by the report
related to the May 9, 2010 fall. P. Ex. 19 at 8. The investigator recommended no new
interventions following the second fall on May 20. The IDT again noted the resident’s
significant cognitive impairment, his noncompliance with the care plan, the fact he took
psychotropic medications, the fact his vital signs did not reflect a cause for the fall; his
agitation; his impaired decision-making and safety awareness, among other things. The
IDT recommended only a therapy evaluation. P. Ex. 19 at 11. A note was added to
Resident 2’s care plan indicating that he fell, he had no injury, he was confused, and he
lacked sleep. No intervention appears to have been added to the care plan. No
interventions were added to the care plan requiring that resident’s bed be in the low
position or physical therapy. P. Ex. 13, at 4. According to Petitioner, Resident 2 was
sent for PT and OT screening, doctors completed a medication review, OT and PT began
between May 20 and June 6, 2010. PT and OT were discontinued on June 16, 2010 due
to the resident’s refusal to participate. CMS Ex. 5 at 134-35; Tr. 203.

On May 24, 2010, at 4:30 a.m., Resident 2 fell again. The nurse’s note states that the
nurse was called to the resident’s room but who called the nurse is not stated. The
resident was observed to be sitting on the floor with his legs crossed at the ankles and
leaning back against the recliner chair. He said he fell and hit his head on the floor, but

14

no bruising or raised areas were noted. P. Ex. 17 at 65; CMS Ex. 5 at 79. There was no
mention in the documentation as to whether an alarm sounded. The “Change In
Condition Report — Post Fall/Trauma” lists the following interventions as used prior to
the fall: half bedrails, recliner chair, bed/chair alarm, call light within easy reach. Post
fall recommendations list: half bedrails, toileting schedule, bed/chair alarm, wheelchair
positioning, safety cues/reinforcement/reminder, and call light within reach. The IDT
review and recommendations are similar to that of prior fall reports with mention of
psychotropic medications, his diagnoses, impaired cognitive ability, poor decision-
making ability, noncompliance, lack of safety awareness, and the conclusion that his vital
signs do not appear to have been a factor. The IDT’s only recommendation is related to
therapy. The post-fall report states that the care plan was updated but the care plan does
not reflect any updates or changes dated May 24, 2010. P. Ex. 19 at 12-13; P. Ex. 13 at
4. The following interventions listed on the fall investigation report are not listed on the
fall care plan: use of half bedrails, use of a reclining chair, use of a chair alarm, and
therapy. P. Ex. 13 at 4.

A nurse’s note dated May 26, 2010, states that staff were reminded that Resident 2’s
alarms should be answered, but the note does not specify which alarms were in use. The
note also states that he was not supposed to be alone. It is not clear from the note
whether or not the resident was to have constant one-on-one supervision and that
intervention is not documented on the care plan. P. Ex. 17 at 66. A second note dated
May 26, 2010, indicates that the resident was screened at staff request due to frequent
falls. It is noted that it was discussed with the resident’s daughters that the resident was
more weak and unsteady on his feet and, while he had not previously cooperated with
physical therapy, Petitioner was willing to try therapy again. The daughters apparently
requested that physical therapy be delayed one week. P. Ex. 17 at 67. Petitioner
concedes that on May 26, 2010, it was noted that Resident 2 could turn his bed alarm off
independently. CMS Ex. 5 at 159.

A nurse’s note dated May 28, 2010 at 3:46 a.m. states that Resident 2 turned off his alarm
and appeared at the nurse’s desk requesting his car keys. P. Ex. 17 at 67; CMS Ex. 5 at
81, 134. This incident clearly shows that Resident 2 had the ability to turn off his alarms,
but there is no evidence that this was reported to the IDT, the care planning team, and
there is no evidence offered by Petitioner of new interventions to address this problem.

P. Ex. 13 at 1-5; CMS Ex. 5 at 85, 134. Dr. Boero, Petitioner’s Medical Director and
Resident 2’s physician, testified regarding alarms that when a resident learns how to
defeat the alarm it is necessary to adapt by using a different alarm or attaching the alarm
in a way that prevents the resident from disabling the alarm. Tr. 194-96.

There is evidence that the physician issued an order on June 1, 2010 for physical therapy
and occupational therapy evaluation and treatment due to Resident 2’s decreased strength
and increased falls. P. Exs. 14 at 2, 20-24. On June 2, 2010, the physician ordered
physical therapy five times a week for three weeks and then two times a week for one
15

week for therapeutic exercises, balance and gait retraining to decrease Resident 2’s fall
risk. On June 3, 2010, the physician ordered occupational therapy treatment five times a
week for four weeks for therapeutic exercise and ADLs for Resident 2’s generalized
weakness. P. Ex. 14 at 2. Resident 2’s MDS with an assessment reference date of June
11, 2010, reflects a decline in his functioning. He continued to be assessed as severely
cognitively impaired, with a short-term memory deficit, he was easily distracted, and his
mental functioning varied over the course of the day. For bed mobility, Resident 2
required supervision and a one person assist. For transfers and walking in his room,
Resident 2 required limited assistance of one person. Somewhat inconsistently, Resident
2 was assessed as independent with walking in the hall but with the assistance of one
person. For locomotion on and off his unit, the resident was assessed as requiring the
extensive assistance of one person. Toilet use remained the same; limited assistance with
a one person physical assist. He was assessed as requiring partial physical support to
maintain his balance while standing and he continued to have an unsteady gait. P. Ex. 7;
CMS Ex. 5 at 120-23. A nurse’s note dated June 14, 2010, states that the resident had to
call for help as he could not get to a standing position from his low bed. P. Ex. 17 at 71.
A nurse’s weekly review note dated June 27, 2012 states that the resident was discharged
from therapies due to lack of participation (P. Ex. 17 at 74), which is consistent with
orders (P. Ex. 12 at 3). Dr. Boero testified that the physical therapy was discontinued due
the resident’s cognitive impairment and noncompliance. Tr. 202-03. A June 30, 2010
nurse’s note states that the resident set off an alarm when he got up to use the bathroom
and staff responded and assisted. P. Ex. 17 at 75.

A nurse’s note dated July 2, 2010 at 11:26 p.m. states that Resident 2 fell in his room and
suffered a laceration on the back of his head. The noted mentions the resident’s habit of
walking without assistance. There is no mention in the note if any alarm was sounding.
The resident was sent to the emergency room where he had eight staples to close the
laceration. P. Ex. 17 at 76; CMS Ex. 5 at 41-42, 52. A nurse’s note dated July 3, 2010 at
4:05 p.m., mentions that the resident had safety awareness problems and would forget to
use his walker. The note also states that after his return from the hospital he set off the
alarm getting up to go to the bathroom and he had an unsteady gait when staff assisted
him to the bathroom. The note states he set off the alarm a second and a third time on
July 3. A note at 9:58 p.m. on July 3, 2010, states that the resident’s bed alarm was on
and his bed was in the low position. However, the note also states that the resident was
up numerous times asking about his car and staff were giving him one-on-one
supervision. P. Ex. 17 at 76. The “Change In Condition Report — Post Fall/Trauma”
dated July 2, 2010, states that the resident fell in his room in front of the bathroom door.
The report also states that the resident was walking without assistance which was normal
for him and he told staff he was going to the bathroom. The report lists the following
interventions as in effect at the time of the fall: half bed rails, assistive device within
reach, bed/chair alarm, bed in low position, safety cues/reinforcement/reminder, and call
light within reach. The one additional intervention recommended by the investigator
was for a toileting schedule. The IDT review and recommendations section lists as

16

additional interventions a PT screen, gripper socks while in bed, and a repeat x-ray. The
IDT notes that the resident has a history of poor safety awareness; he has a bed alarm to
alert staff to attempts to self-transfer; his bed is in the lowest position; and his call light is
within reach. P. Ex. 19 at 14-15. According to Resident 2’s incontinence risk care plan
with the original date of January 15, 2010, the resident was supposed to be on a toileting
schedule that required that the resident be offered toileting upon arising, before and after
meals, at bedtimes, and when staff made nightly rounds. P. Ex. 13 at 2. I also note that
encouraging the resident to wear gripper socks at night was an intervention added after
the March 13, 2010 fall. P. Ex. 13 at 4-5. The fall care plan does not reflect the addition
of any new interventions based on the fall on July 2, 2010. There is evidence that the
physician issued an order on July 9, 2010 for the resident to ambulate with the standby
assistance of staff to and from the bathroom using the wheeled walker. This order was in
effect through October 2010. P. Ex. 12 at 6,9, 12, 14; P. Ex. 15 at 8; CMS Ex. 5 at 35;
Tr. 204. The physician order is odd in that it only addresses ambulation to and from the
bathroom and not ambulation in the room or the hall. Dr. Joseph Boero, Resident 2’s
physician and Petitioner’s Medical Director, could not explain the anomaly in testimony.
Tr. 204-11. The physician’s note dated July 15, 2010 adds little insight. The physician
notes incorrectly that Resident 2 fell on July 4, rather than July 2. The physician
correctly stated that the resident suffered a head laceration. The physician states that the
resident can no longer walk the distance to the dining room under his own power as he
as become more and more frail. The physician states the resident ambulates and
transfers on his own and that he had bed and chair alarms. The physician noted the
resident seemed tippy on standing. He discontinued one dose of the resident’s
Lorazepam due to the resident risk for falling and he noted that there was a major risk for
falling. P. Ex. 16 at 9-10. Dr. Boero testified that there is very little that can be done
about a resident like Resident 2 who has trouble walking and is supposed to use a walker
but forgets to do so. He testified that the resident needed to be reminded to use his
walker and that one-on-one supervision is very effective, but not practical. He also
opined that it was not standard of care to provide one-on-one supervision except
periodically. Tr. 185-86.

Nurse’s notes show that the resident set off his alarm going to the bathroom on July 4,
2010. P. Ex. 17 at 77. A note dated July 10 states that the resident is overall unsteady on
is feet and needs a walker to get around and sometimes he used a wheelchair. P. Ex. 17
at 81. A nurse’s note dated July 15, 2010 indicates that the resident ambulates
independently with a walker and occasionally he uses a wheelchair for long distances.
There is no mention of the physician’s July 9, 2010 order for standby assistance, even if it
applied only to going to the bathroom. The note also states that the resident has a bed
alarm in bed and a chair alarm in the chair. P. Ex. 17 at 82-83.

On August 18, 2010, at 4:00 a.m., Resident 2 fell. The bed alarm was turned on, but did
not sound. The pull alarm sounded and staff responded to this as Resident 2 yelled for
help. A CNA found Resident 2 lying on his left side in front of his closet. He had on the

17

proper footwear and he stated that he was going to the bathroom. Later that day the CNA
reported small scrapes on Resident 2’s knees, bruising on his left forearm with tiny
scrapes, and bruising on his left outer wrist. The resident was noted to be confused.

P. Ex. 17 at 91; CMS Ex. 5 at 43-45, 57. Petitioner’s “Change In Condition Report —
Post Fall/Trauma” dated August 18, 2010, lists interventions in use prior to the fall:
change in footwear, night light, OT, bed/chair alarm, pain assessment, safety
cues/reinforcement/reminder, call light within reach, and other. Recommended
interventions are the same with the exception that “other” is not checked on the form.

P. Ex. 19 at 16-17. A hand-written entry was made in the Problems/Strengths column of
the falls care plan that indicates the resident fell while ambulating in his rooms with no
injury. No new interventions dated around August 18, 2010 appear on the care plan.

P. Ex. 13 at 4-5.

On September 1, 2010, at 7:00 p.m., Resident 2 fell again. Resident 2 was ambulating
without assistance with his wheeled walker near the nurses’ station and a nurse observed
im fall and strike the back of his head. He suffered a small abrasion to his head and a
small blood blister on his left elbow. P. Ex. 17 at 96. He stated that he tripped over his
own feet. P. Ex. 17 at 96; CMS Ex. 5 at 46-47, 60, 136. Petitioner’s “Change In
Condition Report — Post Fall/Trauma” dated September 1, 2010 lists the following
interventions as being used prior to the fall: night light, bed/chair alarm, bed in low
position, safety cues/reinforcement/reminder, and call light within reach. Recommended
interventions are no different. There is no entry in the area for “IDT Review and
Recommendations.” P. Ex. 19 at 18-19.

Resident 2’s final MDS with an assessment reference date of September 5, 2010, reflects
a continued decline. He continued to be assessed as severely cognitively impaired, with a
short-term memory deficit, he was easily distracted, and his mental functioning varied
over the course of the day. He was also assessed as having altered perception or
awareness of his surroundings. His vision was assessed as being highly impaired.
Resident 2 was assessed as requiring a one person physical assist for all activities with
extensive assistance for locomotion on and off the unit. He was not observed to walk in
the corridor during the observation period for the assessment. He required partial
physical support to maintain balance while standing and he was assessed to have an
unsteady gait. P. Ex. 8; CMS Ex. 5 at 126-30. A physician’s note dated September 16,
2010, indicates that the consulting pharmacist suggested that Resident 2’s agitation and
falling could be due to medication and he recommended that the physician taper some
medication. The physician agreed and ordered a reduction in some medications noting
specifically that the resident sometimes had low blood pressure and risk for falling.

P. Ex. 16 at 11-12. Dr. Boero testified that Resident 2’s psychotropic medication
contributed to his risk for falls but was necessary to control his behaviors. He testified
that it was a matter of weighing risks verses benefits. He testified that he, the consulting
psychiatrist, or the consulting pharmacist initiated medication reviews monthly. Tr. 216-

18

20. The care plan does not reflect any entries related to the September 1, 2010 fall. P.
Ex. 13 at 4-5.

A nurse’s note on October 1, 2010 states that Resident 2 was in a restorative program that
consisted of ambulation to and from the bathroom. P. Ex. 17 at 103. A nurse’s note
dated October 13, 2010, states that the resident caused his bed alarm to sound two or
three times when he tried to get up. P. Ex. 17 at 105.

Resident 2 fell again on October 18, 2010, at 2:50 a.m. in his room. A nurse’s note dated
October 18, 2010 at 7:09 a.m. states that the nurse heard Resident 2 calling out “help me”
The nurse found Resident 2 on the floor, apparently in his room, lying under his
wheelchair on his back with his head raised under the wheelchair seat. He denied any
pain. The note does not state that there was any alarm sounding. P. Ex. 17 at 108; CMS
Ex. 5 at 48-49, 63, 137. Petitioner’s “Change In Condition Report — Post Fall/Trauma”
dated October 18, 2010, states that the fall was related to a transfer, but does not state the
basis for that conclusion. The report lists the following interventions as in use prior to
the fall: change in footwear, night light, OT, bed/chair alarm, pain assessment,
wheelchair positioning, PT, call light within reach. The one recommended intervention
after the fall was safety cues/reinforcement/reminder. The IDT recommendations were to
eep the room free of clutter and well lighted; therapy screen; continue bed and chair
alarm; appropriate footwear; educate the resident to request assistance with transfers; and
medication review. P. Ex. 19 at 21. The care plan did not provide for an alarm in the
wheelchair. There care plan reflects no changes dated about the time of the October 18,
fall. P. Ex. 13 at 1-5.

On October 21, 2010, at around 9:15 p.m., Resident 2 was found sitting on the floor
midway between the bed and the bathroom. There was a skin tear to his right elbow, a
bruise on his left shoulder and he complained of pain with movement of his left shoulder.
He said he got up from his bed and was going to the bathroom but could not recall how

e fell or tripped. There is no documentation that an alarm sounded. P. Ex. 17 at 111;
CMS Ex. 5 at 50-51, 66.; Tr. 114. Petitioner’s “Change In Condition Report — Post
Fall/Trauma” dated October 21, 2010, lists the following interventions as in use prior to
the fall: night light, assistive device within reach; bed/chair alarm; bed in low position;
safety cures/reinforcement/reminder; and call light within reach. The report
recommended that the additional intervention of using a recliner chair because the
resident had been sleeping in the chair in his room and the writer recommended using the
recliner to elevate his feet, apparently in part to prevent him from standing. The “IDT
Review and Recommendations” section of the report lists therapy; bed/chair alarm in
place; psychotropic medication review; and appropriate footwear in place. P. Ex. 19 at
22-23. The IDT review did not address whether the resident was in bed or in his chair
prior to the fall, whether the bed was in the low position; or whether the alarms worked.
The care plan reflects that on October 21, 2010 a notation was added under interventions
that states “alarms at all times — responding quickly.” P. Ex. 13 at 4-5. The evidence

19

includes a physician’s note dated October 21, 2010, in which the physician states that the
resident has not fallen or injured himself recently. P. Ex. 16 at 13. The physician’s note
does not indicate what time the physician saw Resident 2 on October 21. Apparently, the
physician forgot about the fall on October 18, 2010. A nurse’s note dated October 22,
2010 that references the fall on October 21 states that the resident was responding to
“urination urgency.” P. Ex. 17 at 111-12. A nurse’s note dated October 23, 2010, states
that the resident is most comfortable sitting up in his recliner. A nurse’s note dated
October 24, 2010, states that chair and bed alarms were in place because the resident
attempted to get up on his own, and that the resident had set off alarms once or twice
during the day shift. P. Ex. 17 at 113.

Resident 2 died on November 4, 2010 due to congestive heart failure. P. Ex. 17 at 127;
P. Ex. 21.

b. Analysis

The general quality of care regulation, 42 C.F.R. § 483.25, requires that a facility ensure
that each resident receives necessary care and services to attain or maintain the resident’s
highest practicable physical, mental, and psychosocial well-being, in accordance with the
resident’s comprehensive assessment and plan of care that the resident’s care planning
team, the IDT, developed in accordance with 42 C.F.R. § 483.20. The quality of care
regulations impose specific obligations upon a facility related to accident hazards and
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. § 483.25(h). CMS instructs its surveyors that the intent of 42 C.F.R.

§ 483.25(h)(1) and (2) is “to ensure the facility provides an environment that is free from
accident hazards over which the facility has control and provides supervision and
assistive devices to each resident to prevent avoidable accidents.” The facility is
expected to: identify, evaluate, and analyze hazards and risks; implement interventions to
reduce hazards and risks; and monitor the effectiveness of interventions and modify them
20

when necessary. State Operations Manual (SOM), CMS Pub. 100-07, app. PP, Guidance
to Surveyors Long Term Care Facilities, F323 (rev. 27; eff. Aug. 17, 2007).°

The Board has provided interpretative guidance for adjudicating alleged violations of 42
C.F.R. § 483.25(h)(1):

The standard in section 483.25(h)(1) itself —that a facility
“ensure that the 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. [Footnote
omitted.] Ifa facility has identified and planned for a hazard
and then failed to follow its own plan, that may be sufficient
to show a lack of compliance with [the] regulatory
requirement. In other cases, an ALJ may need to consider the
actions the facility took to identify, remove, or protect
residents from the hazard. Where a facility alleges (or shows)
that it did not know that a hazard existed, the facility cannot
prevail if it could have reasonably foreseen that an
endangering condition existed either generally or for a
particular resident or residents.

Maine Veterans’ Home — Scarborough, DAB No. 1975, at 6-7 (2005).

The Board has also explained the requirements of 42 C.F.R. § 483.25(h)(2) in numerous
decisions. Golden Living Ctr. — Riverchase, DAB No. 2314, at 7-8 (2010); Eastwood
Convalescent Ctr., DAB No. 2088 (2007); Century Care of Crystal Coast, DAB No.
2076 (2007), aff’d, Century Care of the Crystal Coast, 281 F. App’x 180 (4th Cir. 2008);
Liberty Commons Nursing and Rehab - Alamance, DAB No. 2070 (2007); Golden Age

° Although the SOM does not have the force and effect of law, the provisions of the Act
and regulations interpreted clearly do have such force and effect. State of Indiana by the
Indiana Department of Public Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991);
Northwest Tissue Center v. Shalala, 1 F.3d 522 (7th Cir. 1993). Thus, while the
Secretary may not seek to enforce the provisions of the SOM, she may seek to enforce
the provisions of the Act or regulations as interpreted by the SOM.
21

Skilled Nursing & Rehab. Ctr., DAB No. 2026 (2006); Estes Nursing Facility Civic Ctr.,
DAB No. 2000 (2005); Northeastern Ohio Alzheimer’s Research Ctr., DAB No. 1935
(2004); Woodstock Care Ctr., DAB No. 1726 (2000), aff’d, Woodstock Care Ctr. v.
Thompson, 363 F.3d 583 (6th Cir. 2003). A facility is not strictly liable for accidents that
occur, but 42 C.F.R. § 483.25(h) requires that a facility take all reasonable steps to ensure
that a resident receives supervision and assistance devices that meet his or her assessed
needs and mitigates foreseeable risks of harm from accidents. Woodstock Care Ctr. v.
Thompson, 363 F.3d at 589 (holding 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. Whether supervision is “adequate” depends in part upon the
resident’s ability to protect himself or herself from harm. Jd. 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 Rehab. & HCC, DAB No. 2054, at 5-6, 7-12 (2006). 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). SOM, App. PP, Tag F323; Woodstock Care Ctr., DAB No. 1726, at 4.

The surveyors charge a violation of 42 C.F.R. § 483.25(h) based on the example of
Resident 2 because he fell on December 15, 2009 with injuries and had to be
hospitalized; after his return to Petitioner he had ten more falls; and after each fall
Petitioner failed to critically analyze the falls to identify and evaluate potential hazards
and risks to determine if new interventions to minimize the risk for falls were necessary.
CMS Ex. 3 at 2. Based on the surveyors’ allegations and the evidence before me, I do
not conclude there was a violation of 42 C.F.R. § 483.25(h) based on the December 15,
2009 fall or the care planning prior to that fall. Rather, for purposes of this decision, I
treat the December 15 fall as establishing that Petitioner recognized that Resident 2 was
at risk for falls, that falls were foreseeable absent interventions to minimize his risk for
falls, and that the IDT had engaged in care planning and adopted certain interventions to
minimize the resident’s risk for accidental injury due to falls. To determine whether or
not there was a deficiency as alleged by the surveyors and CMS, I consider in detail the
facts of each of the other ten falls that occurred on March 13, 2010, May 9, 2010, two on
May 20, 2010, May 24, 2010, July 2, 2010, August 18, 2010, September 1, 2010, October
18, 2010, and October 21, 2010. I consider the evidence of the interventions in use and
not in use at the time of each fall; the evidence of the IDT’s evaluation of the
effectiveness or adequacy of the interventions in use or not at the time of each fall; and
the evidence showing that the IDT determined to implement new or modified
interventions and whether the interventions were actually implemented.

1 infer that the mechanically printed entries on the form titled “Plan of Care,” which was
admitted as evidence by Petitioner, are the interventions adopted by the IDT that were in
22

effect after the December 15, 2009 fall. The December 15 fall occurred in the hall when
Resident 2 was walking without his walker and he tripped on his own feet. I infer that
some of the interventions were adopted by the IDT specifically to address the risk for
falling when the resident attempted to walk or walked with or without his walker. P. Ex.
17 at 9; P. Ex. 19 at 1-4. The interventions listed on the plan of care addressing the risk
for falls were:

e Resident 2 was to wear a cervical collar at all times;

e Transfers were to be with assist of one as needed;

e Staff was to use a gait belt for all assisted transfers;

e Resident 2’s call-light was to be within reach at all times and answered

promptly;

e A bed alarm was to be in place at night;

e Staff was to respond to the call-light promptly as able;

e Staff was to document any falls/injuries and inform the treating physician

and family promptly per facility protocol;

e Falls risk assessment were to be done quarterly and/or as needed;

e The resident was to be assessed for a nursing rehabilitation program if
indicated;

e Therapies were to be as ordered by the physician;

¢ Staff was to ensure the resident’s room was free from clutter to increase
safety with (independent) toileting;

e The resident’s medications were to be assessed for possible adverse
reactions or side effects related to falls and the physician was to be updated
if needed; and

¢ Grab bars on the bed were to be up when the resident was in bed to assist
his mobility and positioning.

CMS Ex. 5 at 85; P. Ex. 13 at 4-5. Other pages of Resident 2’s care plan addressing
other problems also listed interventions that, arguably, would help minimize his risk for
injury due to falls, for example:

e He was to ambulate with limited assistance of one. P. Ex. 13 at 1.

e He was to be monitored for side effects of medication, including unsteady
balance. P. Ex. 13 at 9, 21.

There are physician orders dated January 9 and 11, 2010 for occupational therapy and
gait training that was terminated on February 5, 2010 due to the resident’s cognitive
decline. P. Ex. 14 at 1, Tr. 199-203. There is also evidence of a nursing order from June
25, 2009, that Resident 2 was to have a bed alarm during hours of sleep with the alarm
box at the head of the bed with checks twice each day. The evidence shows that this
order was in effect through October 2010. P. Ex. 12 at 2,5, 8, 11, 14; P. Ex. 15 at 1-7,
23

12, 14, 16, 18. Diane Hengst, RN, who cared for Resident 2, testified that she knew the
resident was supposed to use a walker; the walker was to be available to him at all times;
and he was to be reminded to use the walker. Tr. 575-76. Nurse Hengst did not identify
the source of these interventions, where they were documented, or when they were
implemented. It is surprising that the interventions reflected in the clinical evidence after
the December 15, 2009 fall do not include interventions as described by Nurse Hengst to
ensure that resident walked only with his walker. It is also surprising that the IDT did not
implement interventions related to use of a walker, even though for a time Resident 2 was
limited to a wheelchair. CMS Ex. 19 at 1-4. Resident 2’s MDS with a reference date of
December 24, 2009, shows that he was assessed as requiring limited assistance of one
person for bed mobility, transfers, walking in his room, walking along the corridor,
locomotion on and off the unit and for toilet use. The MDS also shows that his balance
while standing was unsteady and he had an unsteady gait. CMS Ex. 5 at 113-18; P. Ex. 5
at 2-7. The intervention of a toileting schedule was adopted on January 15, 2010. The
toileting schedule intervention required that the resident be offered toileting upon arising,
before and after meals, at bedtimes, and during nightly rounds. P. Ex. 13 at 2. Although
the intervention was listed on a care plan for incontinence, Dr. Boero testified that it was
also an important intervention to prevent falls. Tr. 199-203. DON Grubbs also testified
to the importance of a toileting schedule for a resident like Resident 2. Tr. 491-92.

Resident 2 fell on March 13, 2010, at 11:40 p.m. A nurse heard the resident’s alarm
sounding and she arrived in time to see him fall with resulting injuries. Petitioner’s
investigation report states that the resident fell responding to bladder or bowel urgency.
The report shows that the following interventions were in place at the time of the fall:
ange in footwear; night light; bed/chair alarm; bed in low position; safety cues,
reinforcement, reminder; and call light within easy reach. P. Ex. 19 at 6. The report does
not show that the toileting schedule that was adopted on January 15, 2010 had been
followed. The report does not indicate whether the floor of the resident’s room was clear
of clutter and trip hazards as required by his falls care plan, but does mention that the

oor was dry. The report does not mention the resident’s walker, an assistive device.
The report shows that the IDT did not recommend any new interventions except a
physical therapy screen. The report shows the IDT recognized that the resident had
severely impaired decision-making and was noncompliant with the plan of care at times,
but the IDT made no recommendation for interventions to address those problems. The
IDT review on the report does not reflect any analysis of the effectiveness of the
interventions in place or why the toileting plan may not have been followed. P. Ex. 19 at
6-7. The care plan was updated with three interventions that appear as hand-written
entries: to encourage the resident to wear shoes or gripper shocks at night; the bed alarm
was to be on when the resident was in bed; and his pain was to be monitored for 72 hours.
P. Ex. 13 at 4-5. It appears from Petitioner’s report of investigation of the fall that there
were already interventions regarding footwear and the bed alarm prior to the fall. In fact,
Petitioner’s records show the bed alarm was first ordered June of 2009 and some sort of
alarm alerted the nurse the resident was falling on March 13.

fe)

24

Resident 2 fell on May 9, 2010 at about 6:00 p.m. The resident had been placed in his
bed after the evening meal. A nurse at the nurse’s station heard a loud noise and found
the resident on the floor. His bedside table was overturned and he was injured. P. Ex. 15
at 59; CMS Ex. 5, at 73. Petitioner’s investigation report shows that the resident was
responding to bladder or bowel urgency. The report lists the following interventions as
being in place: half bedrails,'° change in footwear, night light, toileting schedule,
assistive device within reach, bed/chair alarm, safety cues/reinforcement/reminder, and
call light within reach. P. Ex. 19 at 8. The nurse that completed the report recommended
the addition of one intervention which is listed on the report form as wheelchair
positioning. P. Ex. 19 at 9. Notes of the review of the accident by the IDT, which is
responsible for care planning for the resident, state that the resident is known to have
significant cognitive impairment; he is known to be noncompliant at times with the plan
of care; his vital signs did not appear to contribute to his fall, but he has agitation,
impaired decision-making ability, and he lacked safety awareness. The IDT
recommended a therapy screen, but the type of screen is not specified. P. Ex. 19 at 9.
The IDT notes do not reflect an analysis of the effectiveness of the interventions in place
prior to the fall. The IDT notes do not show that the IDT determined whether or not an
alarm sounded. The report indicates that a toileting schedule was an intervention in
effect but the evidence does not reflect that the IDT determined whether or not Resident 2
had been taken to the toilet prior to being put to bed. The IDT notes show that the team
recognized his cognitive deficit, his noncompliance, and his lack of safety awareness; but
the notes do not show that the IDT considered any possible interventions to address those
problems. The notes also show that the IDT considered that he was taking psychotropic
medications but failed to request a pharmacist and physician review to determine whether
the medications may be contributing to the resident’s falls. There is no evidence that any
new interventions were ordered or implemented or that any existing interventions were
modified due to the May 9, 2010 fall.

On May 20, 2010, Resident 2 fell twice. The first fall is reflected in a nurse’s note dated
May 20, 2010 at 1:43 p.m. The note states that Resident 2 had been confused much of
the shift stating that he left his wife with his brother-in-law who was going to die that
afternoon. He used his wheelchair to go to lunch and after lunch he was placed in the
chair in his room with the alarm intact. He was subsequently found walking in the hall
with his walker. The nurse’s note does not mention whether or not the chair alarm was
sounding. Resident 2 lost his balance while walking near the nurses’ station and fell on
his buttocks. The records do not state whether or not staff was assisting Resident 2 while
he was walking with the walker. The nurse’s note states that the floor was dry and the

'° This entry conflicts with the testimony of RN Grace Brehm, who unequivocally
testified that Petitioner does not use side rails. Tr. 574.
25

resident was wearing appropriate footwear. P. Ex. 17 at 62; CMS Ex. 5 at 76. Unlike the
other falls discussed here, Petitioner has produced no report of an investigation or IDT
review of this fall. Accordingly, I conclude that the IDT did no analysis of the cause of
this fall, the effectiveness of interventions in place at the time of the fall, or whether new
interventions needed to be implemented or old interventions needed to be modified to
minimize the resident’s risk for accidental injuries.

Resident 2 fell a second time on May 20, 2010 at about 5:50 p.m. A nurse and CNA
heard a call for help and an alarm sounding and they found the resident on the floor in his
room. The resident’s walker was tipped over and he had his shoes on. His bed was in the
low position and the alarm was active. The resident told staff that he was going to put a
tissue box lying on the floor into the waste basket. P. Ex. 17 at 63; CMS Ex. 5 at 77.
Petitioner’s report of investigation of this fall lists the following interventions in use prior
to the fall: night light; assistive device within reach; bed/chair alarm; pain assessment;
bed in low position; physical therapy; safety cues/reinforcement/reminder; and call light
within reach. The report does not state that appropriate footwear was being used, but I
will infer that the shoes he was wearing were appropriate. The report also does not show
that the toileting schedule and half bedrails were interventions in use as shown on the
report related to the May 9, 2010 fall. The report does not indicate whether there was a
tissue box or other clutter on the floor. The report of investigation indicates that Resident
2 was confused more than normal due to being awake the night before with signs and
symptoms of an upper respiratory infection. No new interventions are recommended by
the person who did the investigation. The report shows that the resident was doing his
usual activities at the time of the fall. However, the report does not state what the
activities were. When the resident fell on May 9, 2010 at about 6:00 p.m. at about the
same time as the 5:50 p.m. fall on May 20, he had been put in bed. The nurse’s note
indicates that the resident had been toileted about 5:00 p.m. but does not state whether he
was put in the bed or his chair after. The note indicates that after the fall he was
“returned to bed.” The fact he had his shoes on is inconsistent with him having been in
bed. Neither the nurse’s note nor the report of investigation state whether the alarm that
sounded was on the resident’s bed or his chair. The IDT could not appropriately assess
the effectiveness of the alarm without knowing which alarm sounded. Even though the
evidence shows the alarm sounded and therefore worked as intended, if it was the chair
alarm the IDT may have considered, for example, whether a reclining chair or a more
reclined chair would be a better intervention to give staff more time to respond to the
alarm. Similarly, if the alarm was on the bed the IDT may have inquired as to why the
resident was wearing shoes in bed, potentially issues of resident’s rights, dignity, or
quality of care, and the IDT may also have considered whether a “concave” or “winged
mattress” may have been an appropriate intervention to delay the resident while staff
responded to an alarm. The IDT noted the resident’s significant cognitive impairment,
his noncompliance with the care plan, the fact he took psychotropic medications, the fact
his vital signs did not reflect a cause for the fall; his agitation; his impaired decision-
making and safety awareness, among other things. The IDT recommended only a

26

therapy evaluation. P. Ex. 19 at 11. The report does not show that the IDT considered
any interventions to address the resident’s behavior, the possible impact of psychotropic
medication, or his impaired cognition and safety awareness, other than the intervention
already in effect to use safety cues, reinforcement, and reminders — an intervention shown
by multiple falls to be mostly ineffective. A note was added to Resident 2’s care plan
indicating that he fell, he had no injury, he was confused, and he lacked sleep. No
intervention appears to have been added to the care plan based on the IDT evaluation of
this fall. P. Ex. 13 at 4. According to Petitioner, Resident 2 was sent for PT and OT
screening, doctors completed a medication review, and OT and PT began between May
20 and June 6, 2010. A nurse’s note dated May 26, 2010, indicates that the resident was
screened at staff request due to frequent falls. It is noted that it was discussed with the
resident’s daughters that the resident was more weak and unsteady on his feet and, while
he had not previously cooperated with therapy, Petitioner was willing to try therapy
again. The daughters apparently requested that therapy be delayed one week. P. Ex. 17
at 67. The physician issued an order on June 1, 2010 for a PT and OT evaluation and
treatment due to Resident 2’s decreased strength and increased falls. P. Exs. 14 at 2, 20-
24. On June 2, 2010, the physician ordered physical therapy five times a week for three
weeks and then two times a week for one week for therapeutic exercises, balance and gait
retraining to decrease Resident 2’s fall risk. On June 3, 2010, the physician ordered OT
treatment five times a week for four weeks for therapeutic exercise and activities of daily
living to address Resident 2’s generalized weakness. P. Ex. 14 at 2. PT and OT were
discontinued on June 16, 2010 due to the resident’s refusal to participate. CMS Ex. 5 at
134-35; P. Ex. 12 at 3; P. Ex. 17 at 74; Tr. 203. Dr. Boero testified that the physical
therapy was discontinued due the resident’s cognitive impairment and noncompliance.
Tr. 202-03. The evidence does not show that the IDT reconsidered the facts of the fall or
the appropriate interventions in light of the resident’s PT and OT failure, which should
have been no surprise to the IDT.

Resident 2 fell again on May 24, 2010 at about 4:30 a.m. The nurse’s note states that the
nurse was called to the resident’s room but who called the nurse is not stated. The
resident was observed to be sitting on the floor with his legs crossed at the ankles and
leaning back against the recliner chair. He said he fell and hit his head on the floor, but
no bruising or raised areas were noted. P. Ex. 17 at 65; CMS Ex. 5 at 79. There was no
mention in the nurse’s note as to whether an alarm sounded or whether the resident fell
from bed or the reclining chair. Petitioner’s report of the investigation of the fall
indicates that the following interventions were in use prior to the fall: half bedrails,
recliner chair, bed/chair alarm, call light within easy reach. The investigation report does
not state that the resident continued to be on a toileting schedule as implemented on
January 15, 2010, or if he was, that he had been toileted according to that schedule.
However, the report of investigation clearly shows that Resident was responding to
bladder or bowel urgency when he fell. P. Ex. 19 at 12. The investigation report does
not state that he was wearing appropriate footwear; that his bed was in the low position;
that his walker was in reach; or that the nightlight was on. The report also does not show

27

that the intervention of safety cues, reinforcement, and reminders was still in effect.
Whoever completed the report -- it is unsigned -- recommended additional interventions
of a toileting schedule and wheelchair positioning. The IDT review and
recommendations are similar to that of prior fall reports with mention of psychotropic
medications, his diagnoses, impaired cognitive ability, poor decision-making ability,
noncompliance, lack of safety awareness, and the conclusion that his vital signs do not
appear to have been a factor, with no evidence that interventions to deal with these
problems were considered by the IDT. The IDT’s only recommendation is related to
therapy. The post-fall investigation report states that the care plan was updated but the
care plan does not reflect any updates or changes dated May 24, 2010. P. Ex. 19 at 12-
13; P. Ex. 13 at 4. As noted in my discussion related to the second fall on May 20,
Resident 2 was sent for PT and OT screening, doctors completed a medication review,
OT and PT began but were discontinued on June 16, 2010 due to the resident’s refusal to
participate. CMS Ex. 5 at 134-35; Tr. 203. The evidence does not show that the IDT
reconsidered the facts of the fall or the appropriate interventions in light of the resident’s
PT and OT failure. The IDT notes on the investigation report form do not show that the
IDT considered that the resident fell while going to the bathroom, that the report does not
show that a toileting schedule was in effect or being followed, or that the person who
completed the report recommended a toileting schedule for the resident.

A nurse’s note dated May 26, 2010, states that staff was reminded that Resident 2’s
alarms should be answered. The note also states that the resident was not supposed to be
alone. It is not clear from the note whether or not the resident was to have constant one-
on-one supervision and that intervention is not documented on the care plan or any
physician order in evidence. P. Ex. 17 at 66. Petitioner concedes that on May 26, 2010,
it was noted that Resident 2 could turn his bed alarm off independently. CMS Ex. 5 at
159. A nurse’s note dated May 28, 2010 at 3:46 a.m. states that Resident 2 turned off his
alarm and appeared at the nurse’s desk requesting his car keys. P. Ex. 17 at 67; CMS Ex.
5 at 81, 134. This incident clearly shows that Resident 2 had the ability to turn off his
alarms, but there is no evidence that this was reported to the IDT and there is no evidence
offered by Petitioner of new interventions to address this problem. P. Ex. 13 at 1-5; CMS
Ex. 5 at 85, 134. Dr. Boero, Petitioner’s Medical Director and Resident 2’s physician,
testified that when a resident learns how to defeat the alarm it is necessary to adapt by
using a different alarm or attaching the alarm in a way that prevents the resident from
disabling the alarm. Tr. 194-96.

Resident 2’s MDS with an assessment reference date of June 11, 2010, reflects a decline
in his functioning and he required more assistance with activities of daily living. P. Ex.
7; CMS Ex. 5 at 120-23. A nurse’s note dated June 14, 2010, states that the resident had
to call for help as he could not get to a standing position from his low bed. P. Ex. 17 at
71.
28

Resident 2 fell in his room on July 2, 2010 at about 8:20 p.m. and suffered a laceration on
the back of his head that required a trip to the emergency room and eight staples. A
nurse’s note records the event mentioning the resident’s history of walking without
assistance but not recording details such as how staff was alerted or what the resident was
doing when he fell. P. Ex. 17 at 76; CMS Ex. 5 at 41-42, 52. The report of investigation
states that Resident 2 was again responding to bladder or bowel urgency and he fell in
front of his bathroom door. The report lists the following interventions as in effect at the
time of the fall: half bed rails, assistive device within reach, bed/chair alarm, bed in low
position, safety cues/reinforcement/reminder, and call light within reach. The report does
not indicate that a toileting schedule was in effect at the time of the fall and the one
additional intervention recommended by the investigator is that the resident have a
toileting schedule. The IDT review and recommendations section lists as additional
interventions a PT screen, gripper socks while in bed, and a repeat x-ray. The IDT notes
that the resident has a history of poor safety awareness; he has a bed alarm to alert staff to
attempts to self-transfer; his bed is in the lowest position; and his call light is within
reach. P. Ex. 19 at 14-15. The report does not indicate whether or not an alarm sounded
or whether staff heard and responded to the alarm. The report does not address why the
investigator did not state that there was a toileting plan that was being followed and felt it
necessary to implement such a plan even though a toileting plan had been implemented
on January 15, 2010. P. Ex. 13 at 2. The IDT adopted the intervention to have the
resident wear gripper socks following the March 13, 2010 fall. P. Ex. 13 at 4-5. Thus,
the IDT’s specification that gripper socks were to be used supports an inference that the
resident was not wearing gripper socks or other appropriate footwear when he fell. The
report also indicates that a night light was no longer an intervention in use for this
resident. Nurse’s notes show that after his return from the hospital, on July 3, 2010 he set
off his alarms multiple times getting up to go to the bathroom and staff on duty decided
to give him one-on-one supervision. P. Ex. 17 at 76. Nurse’s notes show he continued to
set-off his alarm going to the bathroom on July 4, 2010. P. Ex. 17 at 77. The clinical
record does not show that this problem was reviewed by the IDT for additional or
modified interventions. There is evidence that the physician issued an order on July 9,
2010 for the resident to ambulate with the standby assistance of staff to and from the
bathroom using the wheeled walker. This order was in effect through October 2010. P.
Ex. 12 at 6, 9, 12, 14; P. Ex. 15 at 8; CMS Ex. 5 at 35; Tr. 204. The physician order is
odd in that it only addresses ambulation to and from the bathroom and not ambulation in
the room or the hall. Dr. Joseph Boero, Resident 2’s physician and Petitioner’s Medical
Director, could not explain the anomaly in testimony. Tr. 204-11. On July 15, 2010, Dr.
Boero discontinued one dose of the resident’s Lorazepam, a psychotropic medication,
due to the resident’s risk for falls. P. Ex. 16 at 9-10. Dr. Boero testified that there is very
little that can be done about a resident like Resident 2 who has trouble walking and is
supposed to use a walker but forgets to do so. He testified that the resident needed to be
reminded to use his walker and that one-on-one supervision is very effective, but not
practical. He also opined that it was not standard of care to provide one-on-one
supervision except periodically. Tr. 185-86. Dr. Boero’s opinion seems to be at odds

29

with the interventions he implemented after the resident’s sixth fall. Ordering standby
assistance for bathroom trips, which is essentially one-on-one supervision, was clearly an
appropriate intervention. Reducing the resident’s Lorazepam which is well known to
increase the risk for falls due to side effects including increased confusion and light-
headedness or dizziness, was also clearly appropriate. Staff also found it necessary to
implement one-on-one supervision of the resident. Therefore, one-on-one supervision
was clearly possible, at least for limited periods, even with a combative and cognitively
impaired resident such as Resident 2. But it is not for me to say and the focus of my
review is not what interventions were possible and practicable, but whether or not the
IDT did its job of reviewing each fall, the interventions in effect to mitigate the risk for
injury due to falls, the effectiveness of those interventions, and whether the IDT took
action to implement new interventions or modify existing interventions to address the
risks the IDT identified by its investigation and review. Clearly, as of the July 2, 2010
fall, the IDT’s performance in this regard was wholly inadequate. An excellent example
of the IDT’s failure is shown by the fact that the IDT was not addressing that Resident 2
fell several times while attempting to go to the bathroom unassisted. The resident’s care
plan called for a toileting plan as early as January 15, 2010. However, the reports of
investigation already discussed show that the fall investigators were not aware that a
toileting plan was already in effect or being followed prompting the investigators to
recommend implementation of a toileting schedule. The evidence does not show that the
IDT considered the investigators recommendation to implement a toileting schedule. The
evidence also does not show that the IDT questioned why the intervention of using a
toileting schedule adopted January 15, 2010 may not have been followed by staff causing
the resident to need to use the bathroom at night. Other good examples of the IDT’s
failure to analyze falls and the effectiveness of interventions and the need for new or
modified interventions, is the failure of the IDT to address whether or not alarms were
being heard or responded to by staff and the failure of the IDT to specifically address the
resident’s ability to defeat or disable the alarms. The evidence shows that the IDT
performed no better for the falls in August, September, and October.

Resident 2 fell with injury again about 4:00 a.m. on August 18, 2010, while attempting to
go to the bathroom unassisted. The evidence shows that the pressure sensitive alarm in
the bed was on but did not sound, but the pull alarm that was also in use did sound and
staff responded as the resident was calling for help. A CNA found Resident 2 lying on

is left side in front of his closet. He had on the proper footwear and he stated that he
was going to the bathroom. Later that day the CNA reported small scrapes on Resident
2’s knees, bruising on his left forearm with tiny scrapes, and bruising on his left outer
wrist. The resident was noted to be confused. P. Ex. 17 at 91; CMS Ex. 5 at 43-45, 57.
The report of investigation for the fall indicates that the resident was responding to
bladder or bowel urgency when he fell. The report lists the following interventions in
effect at the time of the fall: change in footwear, night light, OT, bed/chair alarm, pain
assessment, safety cues/reinforcement/reminder, call light within reach, and “other” with
nothing written in the blank provided. A toileting schedule is not listed as an intervention

30

in effect. No new interventions are recommended by the unknown investigator. The IDT
review notes list the interventions in effect prior to the fall and list the same interventions
for after the fall, except for “other.” The evidence does not show that the IDT considered
any of the problems or risks that I have previously identified, the effectiveness of existing
interventions, or the need for new or modified intervention. No new interventions dated
around August 18, 2010 appear on the care plan. P. Ex. 13 at 4-5.

Resident 2 fell again on September 1, 2010 at about 7:00 p.m. Resident 2 was
ambulating without assistance with his wheeled walker near the nurses’ station and a
nurse observed him fall and strike the back of his head. He suffered a small abrasion to
his head and a small blood blister on his left elbow. P. Ex. 17 at 96. He stated that he
tripped over his own feet. P. Ex. 17 at 96; CMS Ex. 5 at 46-47, 60, 136. Petitioner’s
investigation of the fall lists the following interventions as being used prior to the fall:
night light, bed/chair alarm, bed in low position, safety cues/reinforcement/reminder, and
call light within reach. Recommended interventions are no different. There is no entry in
the area for “IDT Review and Recommendations” based on which I infer that the IDT did
not conduct a review of the fall or consider the effectiveness of interventions or the need
for new or modified interventions. P. Ex. 19 at 18-19. The care plan does not reflect any
entries related to the September 1, 2010 fall. P. Ex. 13 at 4-5.

Resident 2’s final MDS with an assessment reference date of September 5, 2010, reflects
a continued decline. He was assessed as having altered perception or awareness of his
surroundings. His vision was assessed as being highly impaired. Resident 2 was
assessed as requiring a one person physical assist for all activities, with extensive
assistance for locomotion on and off the unit. He was not observed to walk in the
corridor during the observation period for the assessment. He required partial physical
support to maintain balance while standing and he was assessed to have an unsteady gait.
P. Ex. 8; CMS Ex. 5 at 126-30. A physician’s note dated September 16, 2010, indicates
that the consulting pharmacist suggested that Resident 2’s agitation and falling could be
due to medication and he recommended that the physician taper some medication. The
physician agreed and ordered a reduction in some medications noting specifically that the
resident sometimes had low blood pressure that contributed to the risks for falling. P. Ex.
16 at 11-12. Dr. Boero testified that Resident 2’s psychotropic medication contributed to
his risk for falls but was necessary to control his behaviors. He testified that it was a
matter of weighing risks verses benefits. He testified that he, the consulting psychiatrist,
or the consulting pharmacist, initiated medication reviews monthly. Tr. 216-20.
Medication review seems to be appropriate particularly review of psychotropic
medication. In fact, Dr. Boero previously reduced the resident’s Lorazepam. The
pharmacist triggered the review in this case which demonstrates that Petitioner’s
consulting pharmacist was doing his job. However, there is no evidence that the IDT
considered medication review following the September 1, 2010 fall, which is another
example of the failure of the IDT.
31

A new intervention was implemented about October 1, 2010. A nurse’s note on October
1, 2010 states that Resident 2 was in a restorative program that consisted of ambulation to
and from the bathroom. P. Ex. 17 at 103. A nurse’s note dated October 13, 2010, states
that the resident caused his bed alarm to sound two or three times when he tried to get up.
P. Ex. 17 at 105. There is no evidence of action by the IDT related to the alarms.

On October 18, 2010, at 2:50 a.m. Resident 2 fell in his room. A nurse’s note dated
October 18, 2010 at 7:09 a.m. states that the nurse heard Resident 2 calling out “help me”
and that she found him on the floor, apparently in his room, lying under his wheelchair on
is back with his head raised under the wheelchair sea. The note does not state that there
was any alarm sounding. P. Ex. 17 at 108, CMS Ex. 5 at 48-49, 63, 137. Petitioner’s
report of investigation of the fall indicates the following interventions were in effect:
change in footwear, night light, OT, bed/chair alarm, pain assessment, wheelchair
positioning, PT, call light within reach. The one recommended intervention after the fall
was safety cues/reinforcement/reminder, though there is evidence that that was an
intervention that was supposed to be in effect since the December 2009 fall. The IDT
recommendations were to keep the room free of clutter and well lighted; therapy screen;
continue bed and chair alarm; appropriate footwear; educate the resident to request
assistance with transfers; and medication review, although the IDT notes reflect that the
medication review had already been done. P. Ex. 19 at 21. I doubt that the IDT intended
that the resident’s room be “well lighted” at 2:50 a.m. but the investigation shows that a
night light was once again an intervention that was in use. The report is not clear as to
the facts of this fall. The report states that the resident said his bed broke. The report
also states that the fall was due to an unassisted transfer, but whether from bed to
wheelchair or wheelchair to bed is not specified. The value or appropriateness of the
IDT’s new and modified interventions needs to be judged based upon the facts of the fall
— facts not recorded in the report of the investigation or the nurse’s notes. The report also
oes not reflect that the IDT investigated why previously ordered interventions such as
safety cues, reinforcement, and reminders, were either not being used by staff or were not
adequate. The care plan reflects no changes dated about the time of the October 18 fall.
P. Ex. 13 at 1-5.

The final fall to be considered occurred on October 21, 2010 at about 9:15 p.m. when the
resident again attempted to go to the bathroom unassisted. He suffered injuries due to the
fall. There is no documentation that any alarm sounded. P. Ex. 17 at 111; CMS Ex. 5 at
50-51, 66.; Tr. 114. Petitioner’s report of investigation of this fall indicates that the
following interventions were in effect at the time of the fall: night light, assistive device
within reach; bed/chair alarm; bed in low position; safety cures/reinforcement/reminder;
and call light within reach. The report recommended that the additional intervention of
using a recliner chair because the resident had been sleeping in the chair in his room and
the writer recommended using the recliner to elevate his feet, apparently to prevent him
from standing. I note that prior investigations indicated that a recliner chair was in use
but this inconsistency was not addressed by the IDT. The “IDT Review and

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Recommendations” section of the report lists therapy; bed/chair alarm in place;
psychotropic medication review; and appropriate footwear in place. P. Ex. 19 at 22-23.
The IDT review did not address whether the resident was in bed or in his chair prior to
the fall, whether the bed was in the low position; or whether the alarms worked. The IDT
did not address why the investigator did not indicate that a toileting plan was in effect or
that the plan was being followed. The IDT notes do not show that the IDT considered the
recommendation that the resident have a recliner. The care plan reflects that on October
21, 2010, a notation was added under interventions that states “alarms at all times —
responding quickly,” which was not a new intervention but I will treat it as a modified
intervention to the extent that staff was instructed it must respond quickly. P. Ex. 13 at 4-
5.

The evidence includes a physician’s note dated October 21, 2010, in which Dr. Boero
states that the resident has not fallen or injured himself recently. P. Ex. 16 at 13. The
physician’s note does not indicate what time the physician saw Resident 2 on October 21.
Possibly, the physician forgot about the fall on October 18, 2010.

A nurse’s note dated October 22, 2010, that references the fall states that the resident was
responding to a “urination urgency.” P. Ex. 17 at 111-12. A nurse’s note dated October
23, 2010, states that the resident is most comfortable sitting up in his recliner. A nurse’s
note dated October 24, 2010, states that chair and bed alarms were in place because the
resident attempted to get up on his own, and that the resident had set off alarms once or
twice during the day shift. P. Ex. 17 at 113.

I conclude, based upon the foregoing analysis of the facts, that Petitioner violated 42
C.F.R. § 483.25(h) based on the example of Resident 2, with Resident 2 suffering actual
harm from several of the ten falls he suffered between March and October 2010.

I agree with Petitioner that a facility is not strictly liable or subject to a conclusion that it
was negligent per se simply because an accident occurred. However, 42 C.F.R.

§ 483.25(h) requires that a facility take all reasonable steps to ensure that a resident
receives supervision and assistance devices that meet his or her assessed needs and to
mitigate foreseeable risks of harm from accidents. Woodstock Care Ctr. v. Thompson,
363 F.3d at 589. While a facility is permitted the flexibility to choose the methods of
supervision it uses to prevent accidents, the chosen methods must be adequate under the
circumstances. 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
Rehab. & HCC, DAB No. 2054, at 5-6, 7-12 (2006). In this case, the evidence showed
that Resident 2 was unable to conform his conduct to the wishes of Petitioner’s staff. He
was consistently noncompliant with instructions and often abusive of staff. He was not

33

physically strong throughout the period reviewed. The facts related to his fall in
December 2009 and his assessment by staff made it foreseeable that he would have future
falls and the risk for future falls became more certain with each fall after the March 2010
fall. There is no dispute that Petitioner attempted many interventions to mitigate the risk
for falls but the evidence CMS presented shows that those interventions were not
consistently applied, the facts related to falls were not investigated and reported to the
IDT, the effectiveness of interventions was not assessed, and new or modified
interventions were not implemented to address the resident’s risk for falls. Petitioner’s
evidence does not rebut the CMS prima facie showing, but in fact supports it by
providing a more clear picture of the failures of Resident 2’s IDT.

I conclude that Petitioner violated 42 C.F.R. § 483.25(h) based on the example of
Resident 2 and there was a risk for more than minimal harm. Accordingly, there is a
basis for the imposition of an enforcement remedy.

4. A PICMP of $5,500 is a reasonable enforcement remedy.

I have concluded that Petitioner violated 42 C.F.R. § 483.25 and the evidence shows that
the violation caused Resident 2 to suffer actual harm. 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 per day CMP for the number of days that the facility is not in compliance or a
PICMP for each instance that a facility is not in substantial compliance, whether or not
the deficiencies pose immediate jeopardy. 42 C.F.R. § 488.430(a). The minimum
amount for a PICMP is $1,000 and the maximum is $10,000. 42 C.F.R.

§ 488.438(a)(2). I conclude that there is a basis for the imposition of a PICMP in this
case. The PICMP proposed by CMS is slightly above the middle of the authorized range.

If I conclude, as I have in this case, that there is a basis for the imposition of an
enforcement remedy and the remedy proposed is a CMP, my authority to review the
reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e). The limitations are: (1)
I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of
discretion by CMS in selecting to impose a CMP; and (e) I may only consider the factors
specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP
amount. In determining whether the amount of a CMP is reasonable, 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 deficiencies as set forth at 42 C.F.R. § 488.404(b), the same
factors CMS and/or the state were to consider when setting the CMP amount; and (4) the
facility’s degree of culpability, including but not limited to the facilities neglect,
indifference, or disregard for resident care, comfort, and safety and the absence of
culpability is not a mitigating factor. The factors that CMS and the state were required to
consider when setting the CMP amount and that I am required to consider when assessing

34

the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b): (1) whether the
deficiencies caused no actual harm but had the potential for minimal harm, no actual
harm with the potential for more than minimal harm, but not immediate jeopardy, actual
harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety;
and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread. My
review of the reasonableness of the CMP is de novo and based upon the evidence in the
record before me. I am not bound to defer to the CMS determination of the reasonable
amount of the CMP to impose but my authority is limited by regulation as already
explained. I am to determine whether the amount of any CMP proposed is within
reasonable bounds considering the purpose of the Act and regulations. Emerald Oaks,
DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 14-16
(1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No.
1629 (1997).

I have reviewed the factors and the evidence presented by the parties. I have considered
Petitioner’s history of noncompliance, including one citation of a deficiency under Tag
F323 in 2008 that allegedly posed a risk for more than minimal harm. CMS Ex. 11.
Petitioner’s history does not weigh heavily against Petitioner. Petitioner has not
presented evidence to show that it is unable to pay the PICMP. I conclude that the
deficiency was serious based on the repeated actual harm suffered by Resident 2. I also
conclude that Petitioner was culpable in its failure to act as required by the regulations to
protect Resident 2 from very foreseeable risks of harm due to accidental falls.

I conclude that a PICMP of $5,500 is reasonable to ensure that Petitioner maintains its
compliance with program participation requirements. Petitioner was ineligible to be
approved to conduct a NATCEP for a period of two years by operation of law.

5. Other issues raised by Petitioner are without merit or are not within
my authority to decide.

Petitioner argues that the allocation of the burden of persuasion in this case, according to
the rationale of the Board in the prior decisions cited above, violates the Administrative
Procedures Act, 5 U.S.C. § 551 et. seg., specifically 5 U.S.C. § 556(d). Request for
Hearing. Pursuant to the scheme for the allocation of burdens adopted by the Board in its
prior cases, CMS bears the burden to come forward with the evidence and to establish a
prima facie showing of the alleged regulatory violations that posed a risk for more than
minimal harm in this case by a preponderance of the evidence. If CMS makes its prima
facie showing, Petitioner has the burden of coming forward with any evidence in rebuttal
and the burden of showing by a preponderance of the evidence that it was in substantial
compliance with program participation requirements. Petitioner bears the burden to
establish by a preponderance of the evidence any affirmative defense. The allocation of
burdens suggested by the Board is not inconsistent with the requirements of 5 U.S.C.
35

§ 556(d), as CMS is required to come forward with the evidence that establishes its prima
facie case. Furthermore, because the evidence is not in equipoise, the burden of
persuasion did not affect my decision, and Petitioner suffered no prejudice.

Petitioner also argues that the Medicare Act is violated and Petitioner is deprived of due
process if CMS is not required to submit evidence to prove it considered the regulatory
criteria established by 42 C.F.R. §§ 488.404 and 488.438(f). Request for Hearing;

P. Pre-hearing Brief at 25. I reviewed the evidence related to the regulatory factors de
novo and perceive no prejudice to Petitioner because I did not require CMS to submit
evidence related to its consideration of the regulatory factors.

III. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance
with program participation requirements on November 9, 2010. I also conclude that the
enforcement remedy proposed by CMS is reasonable.

/s/
Keith W. Sickendick
Administrative Law Judge