Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Green Oaks Health and Rehabilitation Center
(CCN: 675424),

Petitioner,
v.
Centers for Medicare and Medicaid Services.
Docket No. C-11-810
Decision No. CR2861
Date: July 18, 2013
DECISION

Petitioner, Green Oaks Health and Rehabilitation Center, was not in substantial
compliance with program participation requirements from July 7 through 26, 2011 due to
violations of 42 C.F.R. §§ 483.13(c)(2) and 483.25(h).! There is a basis to impose
enforcement remedies. The declaration of immediate jeopardy related to the violation of
42 C.F.R. § 483.25(h) was not clearly erroneous. The following enforcement remedy is
reasonable: a civil money penalty (CMP) of $3,650 per day for July 7 and 8, 2011 and
$450 per day for the period July 9 through 26, 2011, a total CMP of $15,400. Petitioner

was ineligible to conduct a Nurse Aide Training and Competency Evaluation Program
(NATCEP) for two years.

' References are to the 2010 revision of the Code of Federal Regulations (C.F.R.) in
effect at the time of the survey, unless otherwise stated.
I. Background

Petitioner is located in Athens, Texas, and participates in Medicare as a skilled nursing
facility (SNF) and the state Medicaid program as a nursing facility (NF). From July 6
through 8, 2011, Petitioner was subject to an abbreviated survey to investigate a
complaint and a partial extended survey” by the Texas Department of Aging and
Disability Services (state agency) and found not in substantial compliance with program
participation requirements. CMS notified Petitioner by letter dated July 28, 2011, that it
was imposing the following enforcement remedies: a CMP of $5,650 per day for July 7
and 8, 2011, and a CMP of $1,000 per day beginning July 9, 2011 and continuing until
Petitioner returned to substantial compliance; a denial of payment for new admissions
(DPNA) effective August 12, 2011, if Petitioner did not return to substantial compliance
before that date; directed in-service training; and termination of Petitioner’s provider
agreement effective November 8, 2011, if Petitioner did not return to substantial
compliance prior to that date. Petitioner returned to substantial compliance on July 27,
2011. CMS notified Petitioner by letter dated August 23, 2011, that: Petitioner returned
to substantial compliance; the CMP would continue through July 26, 2011; and that the
termination of Petitioner’s provider agreement and the DPNA were rescinded. CMS
notified Petitioner by letter dated December 13, 2011, that it was reducing the CMP to
$3,650 per day for July 7 and 8, 2011 and to $450 per day for the period July 9 through
26, 2011. Joint Stipulation of Fact (Jt. Stip.); CMS Ex. 1; CMS Ex. 17; Tr. 45-46.

Petitioner requested a hearing before an administrative law judge (ALJ) on September 19,
2011. The case was assigned to me for hearing and decision on September 28, 2011, and
an Acknowledgement and Prehearing Order was issued at my direction. On June 4, 5,
and 6, 2012, a hearing was convened in Dallas, Texas. A transcript of the hearing was
prepared. CMS offered CMS Exs. | through 17. CMS Exs. | through 13, 16, and 17
were admitted as evidence. Tr. 20-42. Petitioner offered Petitioner exhibits (P. Ex.) 1
through 16 that were admitted as evidence. Tr. 42-44. CMS called the following
witnesses: Surveyor Clavion Hall and Surveyor Dee Ann Smith, Registered Nurse (RN).

> The Statement of Deficiencies (SOD) states that an abbreviated standard survey was
conducted to investigate a complaint against Petitioner. Centers for Medicare and
Medicaid Services (CMS) Exhibit (Ex.) 4 at 1. An abbreviated standard survey is
triggered by a complaint; a change of ownership, management, or director of nursing; or
other indicator for a specific concern about a facility’s compliance with participation
requirements. 42 C.F.R. § 488.301. A partial extended survey was also conducted in this
case based upon the surveyor’s finding that Petitioner’s noncompliance resulted in a
substandard quality of care. Social Security Act (Act) § 1819(g)(2), 42 C.F.R. § 488.301;
Transcript (Tr.) 178.
Petitioner called the following witnesses: Kellie Maddux, Certified Nurse Aide (CNA);°
Sandy McGlaun, Licensed Vocational Nurse (LVN); Katherine Dunlap, RN, Petitioner’s
Director of Nursing (DON); Lisa Ferguson, Petitioner’s Administrator; Pearl Merritt, RN,
MSN, Ed.D; Jackie Stephens, RN, corporate nurse for Petitioner’s owner and operator
Southwest Long Term Care; and Cheryl Lynn Morgan, RN. The parties filed post-
hearing briefs and post-hearing reply briefs (CMS Br., CMS Reply, P. Br., and P. Reply,
respectively).

II. 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 at
section 1819 of the Act and 42 C.F.R. pt. 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 denial of payments for new admissions (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

> The name “Maddox” appears in various documents in evidence but I find that those
references are to CNA Maddux who testified at the hearing. Tr. 463.

* 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.

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. pt. 483, subpt. B. Noncompliance refers to any deficiency that
causes a facility not to be in substantial compliance. 42 C.F.R. § 488.301. 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.

CMS is authorized to impose a CMP for the number of days of noncompliance — a per
day CMP - or for each instance of noncompliance — a per instance CMP. 42 C.F.R.

§ 488.430. The regulations specify that 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 CMPs, $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). “Immediate 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. § 488.301 (emphasis in original). The lower range of CMPs,
$50 per day to $3,000 per day, is reserved for deficiencies that do not pose immediate
jeopardy, but either cause actual harm to residents, or cause no actual harm but have the
potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). The only
range for a per instance CMP is $1,000 to $10,000. 42 C.F.R. §§ 488.408, 488.438(a)(2).

Petitioner was subject to a partial extended survey in this case and a proposed CMP of
more than $5,000, causing it to be ineligible to conduct a NATCEP 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 NATCEP. Pursuant to sections 1819(f)(2) and
1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of
NATCEPs and the process for review of those programs. 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. The
Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D. Pursuant to 42 C.F.R.

§ 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of
a NATCEP offered by a SNF or NF that has been: (1) 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)
assessed a CMP of not less than $5,000; or (3) 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
parties agree that Petitioner did not have an approved NATCEP at the time of the survey.
Tr. 52. Pursuant to 42 C.F.R. § 498.3(b)(14) and (16), only the withdrawal of a
previously granted approval to conduct a NATCEP triggers a right to review.

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). The hearing before an
ALJ is a de novo proceeding, i.e., “a fresh look by a neutral decision-maker at the legal
and factual basis for the deficiency findings underlying the remedies.” Life Care Ctr. of
Bardstown, DAB No. 2479 at 33 (2012) (citation omitted); The Residence at Salem
Woods, DAB No. 2052 (2006); Cal Turner Extended Care Pavilion, 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). A facility has a right to appeal a “certification of noncompliance leading to an
enforcement remedy.” 42 C.F.R. §§ 488.408(g)(1), 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 ability to
continue 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, Woodstock Care Ctr. v.
Thompson, 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 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, 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) (remand), DAB No. 1663 (1998) (afi.
remand), aff'd, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL
34813783 (D.N.J. May 13, 1999).

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

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 the evidence and arguments may be specifically discussed in this
ecision. I discuss the credible evidence given the greatest weight in my decision-
making.” I also discuss, as appropriate, the specific evidence I find not credible or that
as little or no probative value. 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
letermined 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.

The SOD for the survey completed on July 8, 2011, alleges that Petitioner violated the
following participation requirements: 42 C.F.R. § 483.13(c)(1)(ii)-(iii), (c)(2)-(4) (Tag
F225 at a scope and severity level (S/S) F, indicating no actual harm with the widespread
potential for more than minimal harm)°; 42 C.F.R. § 483.13(c) (Tag F226 also at S/S F);

> “Credible evidence” is evidence “worthy of belief.” Black’s Law Dictionary 596 (8th
ed. 2004). The “weight of evidence” is the persuasiveness of some evidence compared to
other evidence. Jd. at 1625.

° The SOD does not allege facts that would constitute a violation of 42 C.F.R.
§ 483.13(c)(1)(ii)-(iii) and the parties have stipulated that a violation of those regulatory

(Footnote continued next page.)
and 42 C.F.R. § 483.25(h) (Tag F323 at a S/S J,’ indicating an isolated instance of
immediate jeopardy to resident health and safety). CMS Ex. 4; CMS Ex. 17. CMS
alleges, based upon the survey that ended July 8, 2011, that Petitioner was not in
substantial compliance with program participation requirements from July 7 through 26,
2011, due to violations of 42 C.F.R. §§ 483.13(c) (Tags F225 and F226) and 483.25(h)
(Tag F323). CMS alleges that the violations of 42 C.F.R. § 483.13(c) were widespread
and posed a risk for more than minimal harm and that the violation of 42 C.F.R.

§ 483.25(h) posed immediate jeopardy for Petitioner’s residents.

I conclude that Petitioner did not violate 42 C.F.R. § 483.13(c) (Tag F226) based on
failure to develop and implement policies and procedures prohibiting mistreatment,
neglect, abuse, or misappropriation. However, Petitioner was not in substantial
compliance with Medicare requirements due to violations of 42 C.F.R. §§ 483.13(c)(2)
(Tag F225) for failure to report possible neglect or abuse, and 42 C.F.R. § 483.25(h) (Tag
F323) for failure to eliminate or mitigate the risk for accidental injury to residents. I
conclude that the declaration of immediate jeopardy related to the violation of 42 C.F.R.
§ 483.25(h) (Tag F323) was not clearly erroneous. I conclude that Petitioner’s violations
of 42 C.F.R. §§ 483.13(c)(2) and 483.25(h) provide a sufficient basis for CMS to impose
a CMP of $3,650 per day for July 7 and 8, 2011, and $450 per day from July 9 through
26, 2011.

1. Petitioner violated 42 C.F.R. § 483.13(c)(2) (Tag F225).

2. Petitioner’s violation of 42 C.F.R. § 483.13(c)(2) (Tag F225), posed a
risk for more than minimal harm.

3. Petitioner’s violation of 42 C.F.R. § 483.13(c)(2) (Tag F225), is a
basis for the imposition of an enforcement remedy.

4. Petitioner did not violate 42 C.F.R. § 483.13(c) (Tag F226).

(Footnote continued.)

provisions are not at issue before me. Jt. Stip. 9. Thus, no further consideration is
given to an alleged violation of 42 C.F.R. § 483.13(c)(1)(ii)-(iii).

7 The scope and severity of Tag F323 was lowered after informal dispute resolution
(IDR) from scope and severity K, a pattern of immediate jeopardy, to scope and severity
J.
a. Facts

The findings of fact set forth here apply to all three deficiency citations as all three arise
from the same facts surrounding the death of Resident 1.

Resident 1 was 90 years old when he expired on July 2, 2011. P. Ex. 16. Petitioner’s
report of the investigation of Resident 1’s death provides undisputed facts. CMS Ex. 8 at
1-3; P. Ex. 3. DON Dunlap testified that the investigation documented in an incident
report was started on July 2, 2011, because Resident | was found on the floor. Tr. at 696,
637-38. On July 2, 2011, CNA Kellie Maddux found Resident | on the floor in his room.
LVN Nikki Mills was summoned, responded to the scene, and determined that Resident 1
had no pulse or other vital signs; he had no apparent injury and there was no bleeding;
and he was warm to the touch. Resident 1 was pronounced dead at the scene at
approximately Noon on July 2, 2011. CMS Ex. 8 at 1-3; P. Ex. 3 at 1-2, 16.

Petitioner collected statements from several staff as part of the investigation. CNA
Christine Warden provided a statement dated July 6, 2011, in which she stated that she:
put Resident 1 in his room in his wheelchair; turned on the chair alarm; told CNA
Maddux where the resident was; assisted CNA Maddux with another resident; and then
returned to work in her own hall. She learned after lunch that Resident 1 had died. P.
Ex. 3 at 10. After learning of Resident 1’s death on July 2, 2011, CNA Warden left the
facility and did not return until July 6, 2011, when she gave her statement and her
employment with Petitioner was terminated. DON Dunlap testified that CNA Warden
was fired, in part, because she left Resident 1 unattended in his wheelchair in his room.
Tr. 699, 703, 730.

CNA Kellie Maddux’s statement dated July 2, 2011, is consistent with the statement of
CNA Warden that CNA Warden assisted her with Resident 1 and that CNA Warden told
her that Resident 1 was in his room unattended but with his alarm. CNA Maddux stated
that after being told by CNA Warden that the resident was in his room unattended, she
kept looking-in on him while providing care to other residents and he was sitting up. But
then she found him on the floor and realized he was dead. P. Ex. 3 at 12. CNA Kellie
Maddux testified at hearing that she regularly provided care for Resident 1 and he had a
pressure alarm on his bed and his wheelchair and he had a history of turning off his
alarms and also attempting to self-transfer. Tr. 468-69, 496-501. She recalled the in-
service training in January 2011, and understood that if a resident had an alarm and they
were taken to their room, they were to be placed in bed, unless they refused. Tr. 472,
503. She understood she was to follow the in-service to the best of her ability. Tr. 518-
19. She testified that if she deviated from in-service training she was to report to her
supervisor. Tr. 473, 507. She testified that Resident | had a high-low bed that could be
adjust from high to low position and bed-side mats. Tr. 491. She testified that Resident 1
was in her line-of-sight when he was in his room at the relevant times on July 2, 2011,

and that it was easier to keep an eye on him in his room than it would have been had he
been in the common areas of the facility. Tr. 482-83. However, she also testified that
she was not on Resident 1’s hall for an undetermined amount of time that morning and
that when she returned to Resident 1’s hall she found him on the floor. She admitted that
when she left her hall she did not ask anyone to watch Resident 1. Tr. 480, 512. She
testified that after finding Resident 1 on the floor, she checked his chair alarm and it was
not on. Tr. 513. It is undisputed that she did not see him fall.

LVN Tiffany Poff’s statement dated July 10, 2011 (eight days after Resident 1’s death)
indicates that CNA Maddux reported to her and LVN Simms that something was
seriously wrong with Resident 1. LVN Poff states that when she entered the resident’s
room the resident was on the floor in front of his wheelchair in a fetal position with a
sheet around the side of his head. LVN Poff observed that the pressure sensitive alarm in
the resident’s wheelchair was off. LVN Poff observed that Resident 1 had a hematoma
between his eyes. P. Ex. 3 at 5-8. LVN Simms states in her July 10, 2011 statement that
she accompanied LVN Poff to Resident 1’s room. She noted that the resident was lying
on the floor between his bed and his wheelchair. She noted that the tab alarm in his
wheelchair was not sounding. She observed a large hematoma between his eyes. P. Ex.
3 at 13. LVN Simms also records in her statement that LVN Poff confronted CNA
Warden about leaving Resident | in his room unattended in his wheelchair and that
Resident | fell, suffered a large hematoma, and died. LVN Simms states that CNA
Warden admitted that she did not test the alarm in the resident’s wheelchair to determine
if it was on. P. Ex. 3 at 13-14. CNA Sumpter’s statement dated July 9, 2011, indicates
that she also went to the resident’s room to assist and she reported seeing a knot on the
resident’s forehead that had not been there in the morning. P. Ex. 3 at 9. CNA Tiffany
Nix, who helped prepare Resident 1 for transport to the funeral home, reported in her
statement dated July 8, 2011 (six days after Resident 1’s death) that she had seen a small
bruise between Resident 1’s eyes. P. Ex. 3 at 3. RN Neal stated in her July 8, 2011
statement that she examined the resident prior to pronouncing him dead and saw no
bruising. P. Ex. 3 at 4.

Resident 1 suffered from Parkinson’s disease and was assessed as at risk for injury due to
tremors and involuntary muscle movement. P. Ex. 4 at 2. He suffered from atrial
fibrillation with chest pain and irregular pulse; anemia with weakness; dementia; macular
degeneration or glaucoma; and he required assistance from one or two staff for his
activities of daily living. CMS Ex. 7 at 1, 54; P. Ex. 4 at 3, 5, 6; P. Ex. 16. Resident 1

ad executed a do not resuscitate (DNR) order. Tr. 47. Resident 1 was assessed as
aving a history of falls and at high risk for falls. P. Ex. 10. The interventions listed on
is care plan dated October 2, 2010, included: encouraging to request staff assistance;
ensuring the call-light was in reach and answered promptly; therapy evaluation and
treatment; anticipating needs to provide prompt assistance; assuring lighting was
adequate and that his area was clutter free; and encouraging attendance of activities as

10

tolerated. CMS Ex. 7 at 55-56; P. Ex. 4 at 7-8. Resident 1 had unobserved falls on
January 25, January 30, and February 5, 2011. CMS Ex. 8, at 20-23, 24-25, 27, 28-29.

Five care plans dated August 3, 2010, August 17, 2010, January 25 and 30, 2011 and
February 5, 2011, all of which refer to falls the resident suffered in his room, are in
evidence. All five of the care plans list the same 12 interventions that primarily focus
upon what to do if the resident falls: notify the physician; assess for injuries; do not
move until assessment, including vital signs, is completed; treat as ordered by the
physician; complete a new fall assessment; monitor for the cause of the fall and eliminate
the cause if possible; assess need for safety equipment or change in footwear; initiate a
rehabilitation screen; assess for change in physical condition such as an infection; assess
for a bowel and bladder program; assess for changes in the environment; and notify the
family. CMS Ex. 7 at 68-70, 72-73; P. Ex. 4 at 9-11. Although not listed in any of the
fall care plans offered by Petitioner, Resident 1’s physician had ordered on September 1,
2010, that a chair alarm be used when he was up in his wheelchair to alert staff and to
remind Resident | to request assistance with transfers. P. Ex. 5 at 1. Orders dated
September 14 and December 30, 2010, required alarms for both the wheelchair and the
bed that were to be checked every shift. CMS Ex. 7 at 4; P. Ex. 5 at 2, 5-10. DON
Dunlop testified that Resident | had interventions to prevent falls or reduce the risk for
injury from falls that included: a high-low bed, bed-side mats, a toileting schedule,
therapy, and pressure alarms for his bed and chair. Tr. 565-66. None of the printed care
plans in evidence listed the interventions DON Dunlop testified were in use for Resident
1. However, she explained that the care plans in evidence as P. Ex. 4 at 9, 10, and 11, are
simply stock forms and interventions are also found in the physician orders and the
“AccuNurse” system, Petitioner’s digital records system. CMS Ex. 7 at 55-56, 68-70, 72-
73; P. Ex. 4 at 7-11; Tr. 568-73. The evidence does not show that new interventions were
adopted and implemented by the interdisciplinary team (IDT) to address Resident 1’s fall
risk, his ability to turn-off his alarm, or his attempts to self-transfer following the January
25, January 30, and February 5, 2011 falls, except the instruction from the January 31,
2011 in-service training, not to leave a resident with a chair alarm unattended in a
wheelchair in the resident’s room. It is undisputed that the resident had no falls between
February 5 and July 2, 2011.

The regulations at 42 C.F.R. pts. 483 and 488 and the State Operations Manual (SOM)
CMS pub. 100-07, app. PP, Guidance to Surveyors Long Term Care Facilities Tag F279
(rev. 70 eff. Jan. 7, 2011)* do not specify a format for a care plan. Accordingly, I review

® The SOM does not have the force and effect of law. However, the provisions of the
Act and regulations interpreted by the SOM clearly do have such force and effect. Ind.
Dept. of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest Tissue Ctr. v.
Shalala, | F.3d 522 (7th Cir. 1993). Thus, while the Secretary may not seek to enforce

(Footnote continued next page.)
11

all the clinical evidence in an attempt to identify all care planned interventions in effect at
a given time, including physician orders, records of instructions to staff for the delivery
of care and services, records of the delivery of care and services, and similar records. In
addition to the specific care and services planned for a resident as reflected in the
resident’s clinical records, I consider the policies and procedures that a SNF adopts that
control or affect the delivery of care and services. Petitioner’s policies, practices, and
procedures are additional evidence that defines or identifies the care plan adopted by the
IDT responsible for care planning as, logically, the IDT determines the specific care and
services necessary for a particular resident in the context of the facility’s generally
applicable policies, practices, and procedures. For example, if Petitioner announced a
policy that no resident with an alarm in his or her wheelchair will be left unattended in
their wheelchair in their room, the IDT could logically conclude that it is not necessary to
specifically order such an intervention for every resident with an order for an alarm in
their wheelchair because Petitioner had adopted the requirement as a policy. Petitioner
ad a policy dated January 1, 2007, that established a policy and procedure for fall risk
assessment and management (fall policy). CMS Ex. 11; P. Ex. 1. Although not specified
in its fall policy, Petitioner educated staff on June 1, 2010, that staff must stay with any
resident with a tab alarm while the resident is in the bathroom and/or uses the toilet. P.
Ex. 2 at 1. Further, on January 31, 2011, Petitioner advised staff that if a resident with an
alarm is taken to the resident’s room, the resident must be placed in bed and not left
unattended. The wording of the in-service training report can be interpreted to mean that
the resident must not be left unattended even after being placed in bed, but given the
context I construe the policy to be that if a resident with a chair alarm is to remain in his
or her room, he or she must be placed in bed and not left unattended in the chair. CMS
Ex. 12; P. Ex. 2 at 4. Resident 1’s physician ordered an alarm for Resident 1’s
wheelchair. Therefore, based on Petitioner’s policies announced in in-service trainings
on June 1, 2010 and January 31, 2011, Resident 1, who had a physician’s order for an
alarm in his chair, was not to be left unattended in the bathroom or while using the toilet
and he was not to be left unattended in his wheelchair in his room. DON Dunlap testified
that Resident 1 was known to turn off the alarm in his wheelchair. She agreed that the in-
service training announcement on January 31 was intended to address falls that Resident
1 experienced in January 2011. Tr. 594-97, 608, 624-25. She testified that the direction
that residents with a chair alarm must not be left unattended in their wheelchair in their
room, but instead must be put to bed, was not practical as staff cannot make a resident go
to bed; the instruction was a guideline; and staff was expected to follow the in-service
instruction but staff also had to use good judgment in applying the instruction. Tr. 602-

(Footnote continued.)

the provisions of the SOM, she may seek to enforce the provisions of the Act or
regulations as interpreted by the SOM.
12

04, 628-29, 704-05. She admitted, however, that the general practice was to put residents
with chair alarms in their bed rather than leave them unattended in their wheelchair. Tr.
607.

Petitioner had a policy that prohibited abuse, neglect, and misappropriation of resident
property. CMS Ex. 9; P. Ex. 12. Petitioner’s policy defines neglect as “failure to provide
goods and services necessary to avoid physical harm, mental anguish, or mental illness.”
CMS Ex. 9 at 3; P. Ex. 12 at 3. Petitioner’s policy requires that any employee who
becomes aware of an allegation of abuse, neglect, or misappropriation will report to a
supervisor, the DON, or the Administrator immediately. The policy requires that
Petitioner report to the state agency in accordance with state law. CMS Ex. 9 at 9; P. Ex.
12 at 9.

It is not disputed that Administrator Ferguson was informed by staff about the July 2,
2011 incident involving Resident 1, but she did not immediately report the incident to the
state agency. Administrator Ferguson testified that three nurses called her on July 2,
2011, about the incident. Administrator Ferguson testified that she did not immediately
notify the state agency about Resident 1 because she did not believe she had to. Tr. 743-
51, 755, 759, 771-72. Administrator Ferguson testified that the fact that Resident 1 was
left in his room unattended did not affect her decision about calling the state agency.
However, she testified that if she had been advised that Resident 1 had an injury, such as
the hematoma reported by some staff, she would have reported the incident to the state
agency. Tr. 786. Administrator Ferguson testified that DON Dunlap could also have
reported to the state agency (Tr. 806-07) but DON Dunlap did not do so as she was on
vacation at the time. Tr. 634, 710, 747. DON Dunlap testified that Administrator
Ferguson usually made the final decision regarding whether an incident was reported to
the state agency. Tr. 721.

b. Analysis Related to Tag F225

Section 1819(c)(1)(A)(ii) of the Act requires that a SNF protect its residents and promote
their “right to be free from physical or mental abuse, corporal punishment, involuntary
seclusion, and any physical or chemical restraints imposed for purposes of discipline or
convenience and not required to treat the resident’s medical symptoms.” The Secretary
has provided by regulation that a “resident has the right to be free from verbal, sexual,
physical, and mental abuse, corporal punishment, and involuntary seclusion.” 42 C.F.R.
§ 483.13(b). The regulations require that a facility develop and implement written
policies and procedures prohibiting mistreatment, neglect, and abuse of residents and the
misappropriation of residents’ property. 42 C.F.R. § 483.13(c). Under section 483.13(c),
the facility must “[n]Jot use verbal, mental, sexual, or physical abuse, corporal
punishment, or involuntary seclusion.” 42 C.F.R. § 483.13(c)(1)(i).

13

The surveyors allege generally that Petitioner violated 42 C.F.R. § 483.13(c)(2), (3), and
(4), because Petitioner failed to thoroughly investigate and report the death of Resident 1.
The surveyors allege specifically that Resident 1 had a history of falls; he was to have a
personal alarm in his wheelchair; he was not to be left unattended in his wheelchair in his
room; he was left unattended; he was found on the floor; his alarm was not sounding;
Petitioner did not report to the state or thoroughly investigate; and Petitioner’s failure
placed 55 residents at risk for abuse or neglect. CMS Ex. 4 at 1-3. The requirements of
42 CFR. § 483.13(c)(2), (3), and (4) are:

(2) The facility must ensure that all alleged violations
involving mistreatment, neglect, or abuse, including injuries
of unknown source, and misappropriation of resident property
are reported immediately to the administrator of the facility
and to other officials in accordance with State law through
established procedures (including to the State survey and
certification agency).

(3) The facility must have evidence that all alleged violations
are thoroughly investigated, and must prevent further
potential abuse while the investigation is in progress.

(4) The results of all investigations must be reported to the
administrator or his designated representative and to other
officials in accordance with State law (including to the State
survey and certification agency) within 5 working days of the
incident, and if the alleged violation is verified appropriate
corrective action must be taken.”

The evidence shows that Petitioner conducted a thorough investigation and maintained
the records of that investigation. There was no allegation of abuse, only neglect, and the
surveyors do not allege in the SOD that there was a failure to protect residents during the

° The SOD does not specifically allege that Petitioner violated 42 C.F.R. § 483.13(c)(4)
by failing to report the results of its investigation to the state agency within five working
days of the incident. CMS Ex. 4 at 2. To the extent that the allegations of the SOD may
be read broadly to include the allegation that Petitioner failed to timely report the results
of its investigation, I conclude it is unnecessary to address that allegation because I
conclude that there is a violation of 42 C.F.R. § 483.13(c)(2). Furthermore, by my
calculation, the time for filing the report of investigation did not expire until July 11,
2011, after the survey was completed. Tr. 154-57.
14

investigation. Even if the allegations of the SOD are construed broadly to include an
alleged failure to protect residents, the evidence shows that CNA Warden, who left
Resident | unattended, left the facility after the incident on July 2, 2011, and she only
returned to prepare her statement and be terminated. I find no violation of 42 C.F.R.

§ 483.13(c)(3). CMS Ex. 8 at 1-3; P. Ex. 3. While the investigation may not have met
the expectation of the surveyors, the regulation and the SOM provide no standard for
thoroughness, legal or otherwise, to which Petitioner was bound to comply. Petitioner’s
staff began the investigation almost immediately as reflected by P. Ex. 3. The
investigation shows that on July 2, 2011, CNA Warden left Resident | in his room, in his
wheelchair, and unattended, contrary to Petitioner’s policy and practice that residents
with alarms in their chair should not be left unattended. The statements collected during
the investigation show that staff recognized that there was a violation of Petitioner’s
policy and practice against leaving residents with alarms in wheelchairs unattended.
Whether or not CNA Warden turned on or off the resident’s alarm or whether or not it
malfunctioned are not questions that need be resolved. Leaving the resident unattended
in his room in his wheelchair violated his care plan as it was understood and applied in
light of Petitioner’s policy and practice. Leaving the resident alone in his room in his
wheelchair arguably amounted to neglect because there was failure to deliver services
necessary to prevent physical harm,"” i.e., appropriate supervision. Whether or not
Resident | died before he fell or after he hit the floor is also a fact issue that need not be
resolved, as there is no dispute he was alive when CNA Warden left him unattended in
his room in his chair. The investigation permitted the essential factual findings of who,
what, when, where, how, and why. The investigation that Petitioner’s staff conducted
was timely and thorough enough to identify necessary remedial action by Petitioner.
There is no allegation in the SOD that the report of the investigation was not delivered to
the state agency within five working days as required by state and federal law.
Accordingly, I find no violation of 42 C.F.R. § 483.13(c)(4).

I nevertheless conclude that there was a regulatory violation because it is undisputed that
Petitioner’s Administrator and DON failed to report the alleged incident of neglect
immediately to the state agency as required by 42 C.F.R. § 483.13(c)(2).'! I further
conclude that the violation posed a risk for more than minimal harm.

'° Neglect is defined by the regulations to be “failure to provide goods and services
necessary to avoid physical harm, mental anguish, or mental illness.” 42 C.F.R.
§ 488.301.

'' The regulation includes two reporting requirements: (1) immediately following the
allegation to the administrator and state; and (2) upon the completion of the investigation
within five days to the administrator and state. 42 C.F.R. § 483.13(c)(2) and (4). The

(Footnote continued next page.)
15

The federal regulation requires that all allegations of mistreatment, neglect, or abuse be
reported to officials in accordance with state law. 42 C.F.R. § 483.13(c)(2). The
pertinent Texas Administrative Code provisions applicable to the operation of long-term
care facilities require that all alleged violations involving mistreatment, neglect, or abuse
be reported immediately to the facility administrator and to other officials in accordance
with Texas law, specifically 40 Tex. Admin. Code § 19.602. 40 Tex. Admin. Code

§ 19.601(c)(2) (2006). A facility owner or employee “who has cause to believe that the
physical or mental health or welfare of a resident has been or may be adversely affected
by abuse, neglect, or exploitation caused by another must report the abuse, neglect, or
exploitation.” 40 Tex. Admin. Code § 19.602(a) (2004). “The person reporting must
make the telephone report immediately on learning of the alleged abuse, neglect,
exploitation, conduct, or condition.” 40 Tex. Admin. Code § 19.602(b)(1). The facility
is required to conduct an investigation and report the results no later than the “fifth
working day after the oral report.” 40 Tex. Admin. Code § 19.602(b)(2).

The Texas statute in effect at the time of the initial determination by CMS provided:

A person, including an owner or employee of an institution,
who has cause to believe that the physical or mental health or
welfare of a resident has been or may be adversely affected
by abuse or neglect caused by another person shall report the
abuse or neglect in accordance with this subchapter.

Tex. Health & Safety Code § 242.122(a) (1989). The statute required that a person
“make an oral report immediately on learning of the abuse or neglect” and “make a
written report to the same agency not later than the fifth day after the oral report is
made.””? Tex. Health & Safety Code § 242.122(c) (1989).

The Texas statute and regulation and 42 C.F.R. § 483.13(c)(2) require that a report of
neglect be made immediately. CMS has adopted as a matter of policy in the SOM, app.
PP, Tag F225 that “immediately” means as soon as possible but not more than 24 hours
after discovery of the allegation. The SOM also states the CMS policy that a state cannot

(Footnote continued.)

focus in this case is upon the requirement of 42 C.F.R. § 483.13(c)(2) to report
immediately following the allegation.

® Tex. Health & Safety § 242.122(a) and (c) were recodified at Tex. Health & Safety
Code § 260A.002(a) and (c), effective September 28, 2011, without substantive changes.
16

override the obligation of a SNF to fulfill the requirements of 42 C.F.R. § 483.13(c); the
state cannot alter the types of allegations that must be reported under 42 C.F.R.

§ 483.13(c); and any time frame for reporting by the state does not supersede the
immediate reporting requirement under 42 C.F.R. § 483.13(c). SOM, app. PP, Tag F225.

CMS made a prima facie showing of noncompliance due to a violation of 42 C.F.R.

§ 483.13(c)(2). Staff reported to Administrator Ferguson that CNA Warden left Resident
1 in his wheelchair unattended in his room, contrary to his care plan and facility policy
and practice not to leave residents with chair alarms unattended in their rooms. There is
no dispute that staff recognized CNA Warden’s error and notified the Administrator of
the alleged neglect by CNA Warden. Administrator Ferguson testified that she was
called by LVN Poff on July 2, 2011, following the discovery of Resident 1. She also
testified that she was aware of the July 2, 2011 statement of CNA Kellie Maddux (P. Ex.
3 at 12). Tr. 744-46, 750. The evidence shows that Administrator Ferguson failed to
recognize and treat the reports she received as allegations of neglect by CNA Warden.
There is no dispute that Administrator Ferguson failed to report to the state agency
immediately as required by both Texas and federal law the alleged neglect by CNA
Warden. I conclude that Administrator Ferguson’s failure to report to the state agency
immediately was a violation of 42 C.F.R. § 483.13(c)(2). I further conclude that
Administrator Ferguson’s failure to recognize an allegation of neglect and to notify the
state agency immediately posed a risk for more than minimal harm to other residents in
the facility subject to physical or mental harm due to neglect.

Petitioner has focused upon the narrow allegation in the SOD that it failed to report the
death of Resident 1 to the state (CMS Ex. 4 at 2) rather than the broader allegation of the
SOD under Tag F225 that Petitioner failed to report an incident of alleged neglect to the
state.'° P. Br. at 2-16. Petitioner cites the October 3, 2006 state agency letter with the
subject-line “Provider Letter #06-32 — Guidelines for Reporting Incidents”"* in support of

‘3 The surveyors did not allege in the SOD that Petitioner violated 42 C.F.R. § 483.13(c)
(Tag F224) due to neglect of Resident 1. The surveyors’ allegations under Tag F225 are
that Petitioner failed to report and investigate the incident involving Resident 1 on July 2,
2011, in violation of 42 C.F.R. § 483.13(c)(2), (3), and (4). CMS Ex. 4 at 1-7. The
surveyors’ allegations were clear enough to give Petitioner notice of what to defend in
this case. Petitioner’s focus upon the requirement to report a death is a tactical choice
rather than due to any confusion arising from the allegations of the SOD.

‘4 There was testimony that the Provider Letter has been updated, but no evidence that
the substantive provisions changed. Tr. 192. Neither party offered a copy of an updated
Provider Letter.
17

its argument that there was no obligation to report Resident 1’s death. P. Br. at 4.
Petitioner argues that there is no requirement under either Texas law or federal law to
report a death to the state agency. P. Br. at 5. Petitioner argues that under Provider
Letter #06-32, which both parties recognize is not the law, it is only required to report a
death if unusual circumstances cast doubt on whether or not the death was due to natural
causes. P. Br. at 6; P. Ex. 11 at 2. Petitioner argues that it complied with Provider Letter
#06-32 because there was no evidence that raised a question as to whether or not
Resident | died from natural causes and his death was not required to be reported to the
state agency. P. Br. at 6. Dr. Pearl Merritt testified as an expert on behalf of Petitioner.
She serves on the Texas Department of Aging and Disability Services Long-Term Care
Advisory Committee, which consults on the Provider Letter regarding reporting. Dr.
Merritt opined that the incident regarding Resident 1 was not reportable because it was
not suspicious. P. Reply Br. at 10; Tr. 819, 838, 840, 880, 886, 888. Another of
Petitioner’s expert witnesses, RN Cheryl Lynn Morgan, agreed with Dr. Merritt. She did
not find Resident 1’s death to be suspicious, and she did not think it was reportable under
Provider Letter #06-32, or that there is a basis for citing a violation. P. Reply Br. at 9-10;
Tr. 972, 984. None of Petitioner’s experts addressed the requirement to report an
allegation of neglect to the state agency.

l agree with Petitioner that the state agency Provider Letter #06-32 is not the law and not
enforceable in this proceeding against Petitioner. The law applicable in this case is found
in the Act; the federal regulations, and the state statute and regulations set forth in this
decision. The issue is whether or not Petitioner failed to report to the state agency in
violation of a requirement under the applicable law, not a policy letter issued by the state
agency. I also agree with Petitioner that CMS has cited no federal or state law that
requires reporting a death to the state agency that may be enforced against Petitioner.'°

5 U.S.C. §§ 551(4), 552(a)(1). But federal and state law clearly require immediate
reporting when there is a failure to deliver services necessary to prevent or avoid harm to
aresident. Petitioner does not rebut the CMS prima facie showing that Petitioner’s
administrator failed to report the allegation that CNA Warden left Resident 1 unattended
in his room, in his wheelchair, which is an allegation of neglect. Petitioner has also failed
to establish an affirmative defense to excuse its violation of 42 C.F.R. § 483.13(c)(2).

'S T do not mean to suggest that the reporting requirements established by 42 C.F.R.

§ 483.13(c)(2) do not encompass instances of maltreatment, neglect, or abuse, including
injuries of unknown source, when a death is involved. But this regulation requires
reporting based upon alleged acts or evidence of such acts, not only when there is
resulting injury or death.
18

Petitioner argues that the surveyors erred by citing the deficiency under Tag F225 at a
scope and severity of F, which indicates that the deficiency was widespread. 42 C.F.R.

§ 488.404(b); P. Br. at 16-17. The surveyors’ determination of scope and severity is not
subject to review in this case as that determination has no impact upon the remedy that
may be imposed or the withdrawal of approval of Petitioner to conduct a NATCEP. 42
C.F.R. § 498.3(b)(14); Tr. 48-55. Iam, however, required to consider the severity of a
deficiency when determining the reasonableness of a proposed enforcement remedy. 42
C.F.R. § 488.404. For the purpose of assessing whether the enforcement remedy is
reasonable, I accept Petitioner’s argument that the single violation related to Resident 1 is
an isolated deficiency and not a widespread deficiency.

c. Analysis Related to Tag F226

A SNF is required to “develop and implement written policies and procedures that
prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident
property.” 42 C.F.R. § 483.13(c) (Tag F226). There is no dispute that Petitioner had the
required policy. CMS Ex. 9; P. Ex. 12. There is no allegation that the policy failed to
satisfy the requirements of the regulation. In this case, the surveyors allege that
Petitioner failed to implement its written policy and that the failure to implement violated
42 C.F.R. § 483.13(c) (Tag F226). The surveyors’ conclusion is based upon the alleged
failure of Petitioner to investigate and report the death of Resident 1. CMS Ex. 4 at 7. I
ave concluded that there was no violation based on the adequacy of Petitioner’s
investigation. However, I have concluded that there was a deficiency due to Petitioner’s
failure to report the allegation of neglect related to Resident | that occurred at about the
time of his death on July 2, 2011. I conclude that the single incident of failure to report is
not a sufficient basis to conclude that Petitioner failed to implement its policy prohibiting
mistreatment, neglect, abuse, and misappropriation.

The Board has often held that “multiple or sufficient examples of neglect may support a
reasonable inference that a facility has failed to develop or implement policies and
procedures that prohibit neglect.” Dumas Nursing and Rehab., L.P., DAB No. 2347 at 15
(2010), citing Barn Hill Care Ctr., DAB No. 1848 at 10 (2002)); Emerald Oaks, DAB
No. 1800 at 18; Liberty Commons Nursing & Rehab Ctr. - Johnston, DAB No. 2031
(2006) (applying holding), aff'd, Liberty Commons Nursing & Rehab Ctr. - Johnston v.
Leavitt, 241 F. App’x 76 (4th Cir. 2007). The focus is not simply on the number or
nature of the instances of mistreatment, neglect, abuse, misappropriation, or failure to
follow the facility policy. Rather the focus is whether the facts related to such instances
demonstrate an underlying breakdown in the facility’s implementation of the provisions
of its anti-neglect policy. Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 8 (2012);
Oceanside Nursing & Rehab. Ctr., DAB No. 2382 at 11 (2011); Columbus Nursing &
Rehab. Ctr., DAB No. 2247 at 27 (2009) (holding that an issue under section 483.13(c) is
“whether the circumstances presented, viewed as a whole, demonstrate a systemic
problem in implementing policies and procedures” to prevent neglect).

19

The surveyors did not allege that neglect actually occurred in this case. However, it is
alleged and the evidence shows that the Administrator violated the facility policy because
she failed to report an allegation of neglect immediately. I conclude that the facts related
to the failure to report do not demonstrate an underlying or systemic problem with
implementation of the facility policy prohibiting neglect, abuse, mistreatment,
misappropriation and established procedures for reporting and investigating alleged
incidents. The facts related to the single incident, including the Administrator’s
testimony at hearing, show that she focused upon the death of Resident 1 not upon the
conduct of staff immediately preceding his death. Her focus was whether or not the death
of Resident 1 was unusual or unexpected and, having concluded it was not, she stopped
her examination of the facts. Administrator Ferguson simply failed to examine why
Resident | was in his room, in his wheelchair, unattended, and why his alarm was off or
malfunctioned. As a result, she failed to recognize the allegation of neglect and to timely
report it, even though the incident was thoroughly investigated. Given the facts of this
case and this single incident, I find no systemic failure or problem of implementation.
Accordingly, I conclude Petitioner did not violate 42 C.F.R. § 483.13(c) as alleged under
Tag F226.

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

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

7. Petitioner’s violation of 42 C.F.R. § 483.25(h) (Tag F323), is a basis
for the imposition of an enforcement remedy.

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. The quality of care regulation
imposes 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
20

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
when necessary. SOM, app. PP, Tag F323.

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) (emphasis added).

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 6-7 (2010); Eastwood
Convalescent Ctr., DAB No. 2088 (2007); Century Care of Crystal Coast, DAB No.
2076 (2007), aff'd, 281 F. App’x 180 (4th Cir. 2008); Liberty Commons Nursing &
Rehab - Alamance, DAB No. 2070 (2007); Golden Age Skilled Nursing & Rehab. Ctr.,
DAB No. 2026 (2006); Northeastern Ohio Alzheimer’s Research Ctr., DAB No. 1935
(2004); Woodstock Care Ctr., DAB No. 1726. The regulation does not make a facility
strictly liable for accidents that occur, but it does require that a facility take all reasonable
steps to ensure that a resident receives supervision and assistance devices that meet his or
her assessed needs and mitigates foreseeable risks of harm from accidents. Woodstock
Care Ctr. v. Thompson, 363 F.3d at 589 (noting 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
21

adequate under the circumstances. Whether supervision is “adequate” depends in part
upon the resident’s ability to protect himself or herself from harm. 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). CMS policy provides
that an “accident” is:

[A]ny unexpected or unintentional incident, which may result
in injury or illness to a resident. This does not include
adverse outcomes that are a direct consequence of treatment
or care that is provided in accordance with current standards
of practice (e.g. drug side effects or reaction).

SOM, app. PP (rev. 27 eff. Aug. 17, 2007).

The surveyors’ allege that Petitioner violated this regulation because Petitioner failed to
provide supervision to prevent Resident | from falling from his wheelchair. The
surveyors also allege that the deficiency posed immediate jeopardy on July 7 and 8, 2011,
though obviously not for Resident 1 who died on July 2. CMS Ex. 4 at 12-20. CMS
argues that Resident 1 was assessed as being at high risk for falls and the specific risk of
him falling from his wheelchair was foreseen; the IDT had adopted an alarm for use in
the resident’s wheelchair as an intervention to alert staff if the resident attempted to self-
transfer or was falling; and Petitioner had adopted as a general policy and practice the
intervention that residents with a chair alarm were not to be left unattended in their room
in their wheelchair. CMS alleges Petitioner violated the regulation because the
supervision provided by the alarm was ineffective as the alarm did not function and no
staff was present supervising Resident 1 when he toppled from his wheelchair. CMS Br.
at 7-13.

The pertinent facts are not in dispute. Resident 1 was assessed as having a history of falls
and at high risk for falls. P. Ex. 10. Several interventions were ordered by the IDT to
address his risk for falls. CMS Ex. 7 at 55-56, 68-70, 72-73; P. Ex. 4 at 7-11. None of
the printed care plans in evidence listed interventions such as alarms, a specialized bed,
mats, side-rails, non-slip footwear or other interventions typically found in care plans
intended to mitigate or eliminate the risk for falls or to mitigate the risk for injury due to a
fall. CMS Ex. 7 at 55-56, 68-70, 72-73; P. Ex. 4 at 7-11. But on September 1, 2010,
Resident 1’s physician had ordered that a chair alarm be used when the resident was up in
his wheelchair, in order to alert staff and remind the resident not to attempt to self-
transfer. CMS Ex. 7 at 4; P. Ex. 5 at 1-2, 5-10. Petitioner had also announced policies to
staff regarding the supervision required for residents with an order for an alarm in their
wheelchair and that policy was followed and a practice in the facility. CMS Ex. 12; P.
Ex. 2 at 1, 4. Based on Petitioner’s policies announced in in-service trainings on June 1,
22

2010 and January 31, 2011, Resident 1, who had a physician’s order for an alarm in his
chair, was not to be left unattended in the bathroom or while using the toilet and he was
not to be left unattended in his wheelchair in his room. On July 2, 2011, Resident 1 was
left in his room, in his wheelchair, unattended, and he fell from his wheelchair and the
alarm in his chair failed to sound. The facts establish a prima facie showing of a
violation of 42 C.F.R. § 483.25(h). Resident | was assessed as at risk for falls from his
wheelchair. Therefore, a fall by Resident 1 was foreseeable. The IDT adopted the
intervention of a chair alarm but the chair alarm was not effective on July 2, 2011,
because it did not sound. The fact that Resident 1 may have already been dead when the
alarm should have sounded is not relevant. The IDT had not specifically ordered a level
of supervision for Resident | that appeared in any care plan, physician order, or
instruction to staff, in evidence. However, | infer that the IDT knew of the policies of the
facility announced in in-service training of staff that a resident with a chair alarm was not
to be left unattended in the chair in either the bathroom or the resident’s room.
Petitioner’s staff failed to provide the level of supervision required by Petitioner’s policy
when Resident | was left unattended in his room and in his wheelchair on July 2, 2011.

I further conclude that Petitioner has failed to rebut the prima facie case or to establish an
affirmative defense.

Petitioner argues that an alarm does not prevent a fall. P. Br. at 22. However, as
Petitioner’s expert, RN Morgan, explained, the effectiveness of an alarm depends upon
the proximity of staff. Tr. 981. If staff is in a resident room, or close to the room, the
sounding of an alarm may permit staff enough time to stop the fall. The sounding of an
alarm may also remind a resident not to attempt to rise from the bed or the chair. Even if
an alarm does not prevent a fall, it may signal staff of a fall and permit a quicker first
response. A significant consideration here is that the physician, who is part of the IDT,
ordered the alarm. The physician order specifically stated that the purpose of the alarm
was to alert staff and to remind the resident to request assistance for transferring. P. Ex. 5
at 1. The fact that the alarm did not sound when Resident 1 fell from his chair shows that
the alarm was either not on or it malfunctioned, and in either case that intervention was
not effective at the time of the fall. Although Petitioner asserts that the alarm had been
checked and was working earlier on July 2, Petitioner has not presented evidence to show
why the alarm did not function when the resident fell or that alternative interventions
should have been adequate despite the failure of the alarm. Furthermore, Petitioner’s
witnesses agree that Resident | had the ability to turn off the alarm in the chair and that
he had done so on an unspecified number of occasions. Tr. 469, 595, 623. But Petitioner
points to no intervention to address the problem of Resident | disabling his alarm, which
would render the alarm an ineffective intervention. Contrary to Petitioner’s argument, it
is not sufficient for a facility to assess a resident and then care plan interventions. P. Br.
at 23. The facility is also obliged to assess the effectiveness of interventions to mitigate
or eliminate a perceived accident risk and to modify existing interventions or adopt new
interventions as necessary to protect its residents.

23

Petitioner also attempts to disavow the in-service trainings at which staff was instructed
not to leave residents with chair alarms unattended in the bathroom or their room. CMS
Ex. 12; P. Ex. 2 at 1, 4. Petitioner asserts that the training, specifically the training on
January 31, 2011, was not facility protocol or the standard to which Petitioner should be
held. P. Br. at 15, 23-24. Petitioner’s assertion before me is clearly inconsistent with the
evidence that shows staff was trained on June 1, 2010 and January 31, 2011, that
residents with an alarm were not to be left unattended in the bathroom and or in their
chair in their room. If this was not Petitioner’s policy and practice, why would staff be
instructed that it was? Petitioner elicited opinion testimony from Dr. Merritt, RN
Stephens, and RN Morgan to support an argument that the policy announced in the in-
service on January 31, 2011, was not practical. Tr. 827, 915-16, 974-75. However, those
opinions merit little weight given the fact that staff followed the policy for approximately
six months from January 31, 2011 until Resident 1 fell on July 2, 2011. According to the
evidence before me, the implementation of the policy was the only new intervention to
address Resident 1’s fall risk during the period January 31 to July 2, 2011. When staff
failed to comply with that intervention, Resident | fell. Therefore, the intervention
implemented by the January 31, 2011 in-service must be credited for effectively
preventing a fall by Resident | from February 5 to July 2, 2011. It is also important to
understand that Petitioner’s instruction to staff may have been relied upon by the IDT in
determining appropriate interventions for Resident 1. If the IDT understood the policy
and practice was as announced in the in-service trainings, the IDT may have relied upon
that general policy or practice rather than ordering a specific intervention of increased
supervision. Accordingly, I conclude that Petitioner must be bound by its announced
policy or protocols, even though not reduced to writing or issued in a formal fashion.

Petitioner asserts that there was nothing it could do to prevent Resident 1’s fall from his
chair and his death. Whether or not Resident 1 died due to his fall from his wheelchair or
before his fall is not an issue that I need to resolve. Petitioner assessed Resident | as at
risk for falls and the evidence shows it was foreseeable that he could fall from his
wheelchair. Petitioner had two interventions for supervision of Resident 1, the chair
alarm and the presence of staff when he was up in his chair in his room. The chair alarm
did not work and Petitioner has failed to show why. Also, no staff was present while he
was up in his chair in his room, thus, that intervention was not implemented.

Petitioner’s failure to ensure the interventions requiring supervision were effectively
implemented, supports the conclusion that Petitioner failed to take all reasonable steps to
prevent an accidental fall from the wheelchair, or to mitigate the risk for harm due to
such an accident. Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.25(h).
I also conclude that the violation posed a risk for more than minimal harm as there is no
dispute by Petitioner that a fall from a wheelchair to the floor poses a risk for physical
injury, particularly for an elderly resident with or without co-morbidities.
24

8. The declaration of immediate jeopardy related to the
noncompliance with 42 C.F.R. § 483.25(h) (Tag F323) was not clearly
erroneous.

The surveyors concluded that the violation of 42 C.F.R. § 483.25(h) posed immediate
jeopardy that began July 7, 2011, and was abated on July 8, 2011. CMS Ex. 4 at 13, 18-
20. CMS proposes to impose a CMP in the higher range of CMPs that may be imposed
for immediate jeopardy on July 7 and 8, 2011.

The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows
the declaration of immediate jeopardy to be clearly erroneous. 42 C.F.R. § 498.60(c)(2).
CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has
a heavy burden to demonstrate clear error in that determination. Yakima Valley Sch.,
DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14;
Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville
Nursing Home, DAB No. 1962 at 11 (2005), aff'd, Barbourville Nursing Home v. U.S.
Dep't of Health & Human Servs.,174 F. App’x 932 (6th Cir. 2006)); Maysville Nursing &
Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab Ctr. -
Johnston, DAB No. 2031 at 18-19. Once CMS presents evidence supporting a finding of
noncompliance, CMS does not need to offer evidence to support its determination that the
noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to
show that that determination is clearly erroneous. Cal Turner Extended Care Pavilion,
DAB No. 2384 at 14-15; Liberty Commons Nursing & Rehab Ctr. - Johnston, 241 F.
App’x 76 at 3-4.

“Immediate jeopardy” under the regulations refers to “a situation in which the provider’s
noncompliance with one or more requirements of participation has caused, or is likely to
cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. §§ 488.301,
489.3 (emphasis in original). In the context of survey, certification, and enforcement
related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS
that noncompliance with program participation requirements poses immediate jeopardy
to facility residents, triggers specific regulatory provisions that require enhanced
enforcement remedies, including authority for CMS to impose a larger CMP than may be
imposed when there is no declaration of immediate jeopardy. 42 C.F.R. §§ 488.408(e),
488.438(a)(1)(i), (c), and (d). The regulations also require termination of the facility’s
provider agreement on an expedited basis or the removal of the immediate jeopardy
through appointment of temporary management. 42 C.F.R. §§ 488.410, 488.440(g),
488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate
jeopardy to the health or safety of a facility’s residents is not an initial determination that
triggers a right to request a hearing by an ALJ or that is subject to review. Rather, a

finding of noncompliance that results in the imposition of an enforcement remedy, except
25

the remedy of monitoring by the state, does trigger a right to request a hearing and is
subject to review. 42 C.F.R. §§ 488.408(g); 498.3(b)(8) and (13). Furthermore, the level
of noncompliance, i.e., the scope and severity, is subject to review only if a successful
challenge would: (1) affect the amount of CMP that may be imposed, i.e. the higher
range of CMP authorized for immediate jeopardy; or (2) affect a finding of substandard
quality of care that rendered the facility ineligible to conduct a NATCEP. 42 C.F.R.

§ 498.3(b)(14) and (16). Pursuant to 42 C.F.R. § 498.60(c)(2), in reviewing a CMP, the
ALJ must uphold the CMS determination of the level of noncompliance unless it is
clearly erroneous. The phrase “clearly erroneous” is not defined by the Secretary.

Many appellate panels of the Board have addressed “immediate jeopardy.”'° In
Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented:

CMS’s determination that a deficiency constitutes immediate
jeopardy must be upheld unless the facility is able to prove
that the determination is clearly erroneous. 42 C.F.R.

§ 498.60(c)(2); Woodstock Care Center. The “clearly
erroneous” standard means that CMS’s immediate jeopardy
determination is presumed to be correct, and the burden of
proving the determination clearly erroneous is a heavy one.
See, e.g., Maysville Nursing & Rehabilitation Facility, DAB
No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab
Center — Johnston, DAB No. 2031, at 18 (2006), aff'd,
Liberty Commons Nursing and Rehab Ctr. — Johnston v.
Leavitt, 241 F. App’x 76 (4th Cir. 2007). When CMS issued
the nursing facility survey, certification, and enforcement
regulations, it acknowledged that “distinctions between
different levels of noncompliance . . . do not represent
mathematical judgments for which there are clear or
objectively measured boundaries.” 59 Fed. Reg. 56,116,
56,179 (Nov. 10, 1994). “This inherent imprecision is
precisely why CMS’s immediate jeopardy determination, a
matter of professional judgment and expertise, is entitled to

'© Decisions often cited include: Lakeport Skilled Nursing Ctr., DAB No. 2435 at 6
(2012); Liberty Health & Rehab of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011);
Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111
(2007); Daughters of Miriam Ctr., DAB No. 2067 (2007); Britthaven of Havelock, DAB
No. 2078 (2007); Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No.
1726.
26

deference.” Daughters of Miriam Center, DAB No. 2067, at
15 (2007).

The Board’s statement that the CMS immediate jeopardy determination is entitled to
deference is subject to being misunderstood to limit ALJ and Board review of immediate
jeopardy beyond what was intended by the drafters of the regulations. In the notice of
final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2),
discussing the merits of the reviewability of deficiency citations, selection of remedy, and
scope and severity, commented:

We believe that a provider’s burden of upsetting survey
findings relating to the level of noncompliance should be
high, however. As we indicated in the proposed rule,
distinctions between different levels of noncompliance,
whether measured in terms of their frequency or seriousness,
do not represent mathematical judgments for which there are
clear or objectively measured boundaries. Identifying failures
ina facility's obligation to provide the kind of high quality
care required by the Act and the implementing regulations
most often reflect judgments that will reflect a range of
noncompliant behavior. Thus, in civil money penalty cases,
whether deficiencies pose immediate jeopardy, or are
widespread and cause actual harm that is not immediate
jeopardy, or are widespread and have a potential for more
than minimal harm that is not immediate jeopardy does not
reflect that a precise point of noncompliance has occurred,
but rather that a range of noncompliance has occurred which
may vary from facility to facility. While we understand the
desire of those who seek the greatest possible consistency in
survey findings, an objective that we share, the answer does
not lie in designing yardsticks of compliance that can be
reduced to rigid and objectively calculated numbers. Survey
team members and their supervisors ought to have some
degree of flexibility, and deference, in applying their
expertise in working with these less than perfectly precise
concepts. For these reasons, we have revised the
regulations to require an administrative law judge or
appellate administrative review authority to uphold State
or HCFA findings on the seriousness of facility
deficiencies in civil money penalty cases unless they are
clearly erroneous.

27

59 Fed. Reg. at 56,179 (emphasis added). It is clear from this regulatory history that the
drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination
that there was immediate jeopardy would receive deferential consideration, by adopting
the clearly erroneous standard of review. Thus, caution must be exercised to ensure that
the Board’s decision in Mississippi Care Center of Greenville, Daughters of Miriam
Center, and other decisions that have mentioned deference relative to immediate jeopardy
not be read to require deference for the determination that there was immediate jeopardy
beyond that imposed by adoption of the clearly erroneous standard. Giving or requiring
that the immediate jeopardy determination be given deference in addition to applying the
“clearly erroneous standard” would be contrary to the intent of the drafters of the
regulation; would significantly limit the review of the determination by an ALJ and the
Board; and would impermissibly deny an affected party the due process right to review
intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Center of Greenville, that panel of the
Board states that the clearly erroneous standard means that the “immediate jeopardy
determination is presumed to be correct, and the burden of proving the determination
clearly erroneous is a heavy one.” DAB No. 2450 at 15. Similar formulations have been
used in other Board decisions when referring to the “clearly erroneous standard.”
However, the Board’s characterization of the “clearly erroneous standard” in Mississippi
Care Center and other cases does not define the standard. The “clearly-erroneous
standard” is described in Black’s Law Dictionary as a standard of appellate review
applied in judging the trial court’s treatment of factual issues, under which a factual
determination is upheld unless the appellate court has the firm conviction that an error
was committed. Black’s Law Dictionary 269 (18th ed. 2004). The Supreme Court has
addressed the “clearly erroneous standard” in the context of the Administrative
Procedures Act (APA). The Court described the preponderance of the evidence standard,
the most common standard, as requiring that the trier-of-fact believe that the existence of
a fact is more probable than not before finding in favor of the party that had the burden to
persuade the judge of the fact’s existence. In re Winship, 397 U.S. 358, 371-72 (1970);
Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993). The
“substantial evidence” standard considers whether a reasonable mind might accept a
particular evidentiary record as adequate to support a conclusion. Consolidated Edison,
305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999). Under the
“clearly erroneous” standard a finding is clearly erroneous even though there may be
some evidence to support it if, based on all the evidence, the reviewing judge or authority
as a definite and firm conviction that an error has been committed. United States v.
United States Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162;
Concrete Pipe, 508 U.S. at 622. The clearly erroneous standard has been characterized
by the Court as being stricter than the substantial evidence test and significantly
deferential. The Court stressed in discussing the clearly erroneous standard the
importance of not simply rubber-stamping agency fact-finding. The Court also

28

commented that the APA requires meaningful review.'’ Dickinson, 527 U.S. at 162
(citations omitted); Concrete Pipe, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of
the immediate jeopardy issue. A finding of immediate jeopardy does not require a
finding of actual harm, only a likelihood of serious harm. Dumas Nursing and Rehab.,
L.P., DAB No. 2347 at 19, (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58,
aff'd, Life Care Ctr. of Tullahoma v. Sebelius, 453 F. App’x 610 (2011)). The definition
of immediate jeopardy at 42 C.F.R. § 488.301, does not define “likelihood” or establish
any temporal parameters for potential harm. Agape Rehab. of Rock Hill, DAB No. 2411
at 18-19 (2011). The duration of the period of immediate jeopardy is also subject to the
clearly erroneous standard. Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 7-
8. There is a difference between “likelihood” as required by the definition of immediate
jeopardy and a mere potential. The synonym for likely is probable, which suggests a
greater degree of probability that an event will occur than suggested by such terms as
possible or potential. Daughters of Miriam Ctr., DAB No. 2067 at 10. Jeopardy
generally means danger, hazard, or peril. The focus of the immediate jeopardy
determination is how imminent the danger appears and how serious the potential
consequences. Woodstock Care Ctr., DAB No. 1726 at 39.

What is the meaning of serious injury, harm, or impairment as used in the definition of
immediate jeopardy found in 42 C.F.R. § 488.301? How does serious injury, harm, or
impairment compare with “actual harm?” On the first question the Board recognized in
Yakima Valley School, DAB No. 2422 at 8, that the regulations do not define or explain
the meaning of the term “serious” as used in the definition of immediate jeopardy.'* The

'7 The Board’s characterization of the clearly erroneous standard as being highly
deferential to the fact-finding by the state agency surveyor and CMS, and even triggering
a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization
of the standard. However, the Court’s cautions about ensuring meaningful review rather
than rubber-stamping agency decisions shows it is important for the ALJ and the Board
not to be tempted to simply defer to the surveyor, the state agency, or CMS on the
immediate jeopardy issue.

'S Appendix Q of the SOM also fails to provide surveyors a working definition of the
term “serious” that they can use to determine whether harm, injury, or impairment is
serious when deciding whether or not to declare immediate jeopardy. The Act does not
define the phrase “immediately jeopardize” and does not introduce the concept of serious
harm, injury, or impairment as the basis for finding immediate jeopardy. Thus, one is not
in error concluding that absent a definition of the term “serious” in the Act, the

regulations, the SOM, or decisions of the Board, it is essentially up to individual
(Footnote continued next page.)
29

Board suggested that the definitions may be unimportant because the Board has held that,
under the clearly erroneous standard, once the state agency or CMS declares immediate
jeopardy there is a presumption that the actual or threatened harm was serious and the
facility can only rebut the presumption of immediate jeopardy by showing that the harm
or threatened harm meets no reasonable definition of the term “serious.” Jd. (citing
Daugthers of Miriam Ctr., DAB No. 2067 at 9). In Daughters of Miriam Center, the
Board discussed that the ALJ attempted to define “serious” finding meanings such as
dangerous, grave, grievous, or life-threatening. The Board noted that the ALJ stated that
serious harm is outside the ordinary, requiring extraordinary care, or having lasting
consequences. The Board further noted that the ALJ stated that a serious injury may
require hospitalization, or result in long-term impairment, or cause severe pain, as
opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary
care, does not cause a period of incapacitation, heals without special medical
intervention, or does not cause severe pain. The Board did not endorse or adopt the
ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of
that case. The Board reasoned, as already noted, that the facility bore the burden to rebut
the presumption by showing that the actual or threatened harm met no reasonable
definition of serious. Daughters of Miriam Ctr., DAB No. 2067 at 9.

Applying the clearly erroneous standard to the record before me related to the
noncompliance I have found based on the violation of 42 C.F.R. § 483.25(h), I have no
definite and firm conviction that an error has been committed in the declaration of
immediate jeopardy. I conclude that Petitioner has failed to show that the declaration of
immediate jeopardy for the deficiency under 42 C.F.R. § 483.25(h) was clearly
erroneous.

Petitioner argues that CMS has failed to show that the surveyors strictly complied with
the procedures for declaring immediate jeopardy. P. Br. at 25. Petitioner’s argument is
without merit. The regulation is clear that Petitioner bears the burden of showing that the
declaration of immediate jeopardy is clearly erroneous. The procedures followed by the
surveyors are not at issue except to the extent deviation from procedures might reflect
upon the credibility of their testimony or their findings and conclusions reflected in the
SOD if placed in issue, but they are not in this case.

(Footnote continued.)

surveyors, and whatever unpublished guidance they receive from their superiors or CMS
officials, to exercise their individual discretion and judgment to decide that there was
immediate jeopardy, which subjects a facility to the maximum imposable CMPs.
30

Petitioner argues that Resident 1 was not in immediate jeopardy at the time of the survey
as he was already dead and there is no reference to other residents. P. Br. at 25. Contrary
to Petitioner’s argument, the surveyors alleged in the SOD that there were seven other
residents at risk for accidents and injury due to Petitioner’s noncompliance. CMS Ex. 4
at 13, 20. A fair reading of the allegations of the SOD are that at least seven of
Petitioner’s residents were at risk for likely serious harm, injury, impairment, or death
due to Petitioner’s noncompliance under Tag F323. The seven residents were identified
by the fact that all had personal alarms. CMS Ex. 4 at 20. Petitioner also acknowledged
at hearing that there were other residents in the facility at risk for falls. Tr. 38-39.
Petitioner has not shown that the declaration of immediate jeopardy was clearly
erroneous as to any of its residents who had personal alarms or were at risk for falls on
July 7 and 8, 2011. The range of serious injuries, harm, or impairment that residents
could suffer due to falls from their wheelchairs, beds, or toilets, absent effectively
implemented interventions, are obvious, and include contusions, fractures, head injuries,
and resulting death. The immediacy or likelihood that serious injury, harm, impairment,
or death will result in the near future is evident from the number of residents at risk and
the fact that Resident 1 fell from his chair when unsupervised. Whether or not Resident 1
died due to the fall or suffered no injury from the fall is not determinative as the potential
for serious harm, injury, impairment, or death is sufficient.

Petitioner asserts that for purposes of determining immediate jeopardy, it had no
culpability. P. Br. at 26. Petitioner is in error. The evidence shows that staff was trained
not to leave a resident with an alarm unattended in the bathroom or his or her room. The
evidence shows that CNA Maddux challenged CNA Warden for leaving Resident |
unattended and that other staff was aware that Resident 1 should not have been left
unattended. Petitioner has not shown that after Resident 1’s fall it took action to ensure
that its policy not to leave a resident unattended was enforced or that other effective
interventions were implemented for the other residents with alarms and at risk for falls.
Absent specific interventions listed in an identifiable care plan, physician orders, or some
other document accessible to staff, staff needs to rely upon Petitioner’s policies regarding
the delivery of care and services. Petitioner’s failure to clarify and enforce it policy not
to leave at risk residents unattended or to implement an equally effective intervention, left
staff without the guidance that they needed to ensure that at risk residents were not
subject to imminent risk to fall with serious injury, harm, impairment, or death.
Petitioner also failed to produce evidence that it determined why Resident 1’s alarm did
not sound when he fell from his chair. Petitioner’s failure to take remedial action related
to its policy and failure to investigate the lack of effectiveness of Resident 1’s alarm
shows an indifference which is culpability. The fact that staff responded promptly when
Resident 1 was found dead does not mitigate Petitioner’s culpability for failure to act to
ensure residents with similar risks were not in immediate jeopardy.

Petitioner also argues that it is inconsistent for the surveyors to declare immediate
jeopardy for the deficiency under Tag F323 when immediate jeopardy was not declared

3

1

for the deficiency under Tag F225. This argument does not address Petitioner’s burden
and is of no merit. I note, however, that there is no inconsistency. The deficiency under

Tag F225 was based on the Administrator’s

‘ailure to report the alleged neglect to the

state agency as specifically required by the regulation. The deficiency did not bear

directly upon the quality of care delivered to
F323. Furthermore, Petitioner did do the req
apparently satisfied that there was no citable
Although the surveyors could have viewed t

cited immediate jeopardy, they did not do so.

jeopardy for Tag F225 does not reflect adver:

residents as did the deficiency under Tag
uired investigation and the surveyors were
instance of actual neglect of Resident 1.

e facts related to Tag F225 differently and
The surveyors’ failure to cite immediate
sely upon their credibility or discretion.

Accordingly, I conclude that Petitioner failed to meet its burden to show that the

declaration of immediate jeopardy was clear!

y erroneous.

9. The enforcement remedies of $3,650 per day for July 7 and 8, 2011
and $450 per day for the period July 9 through 26, 2011 are
reasonable.

10. Petitioner was ineligible for two years to be approved to conduct a
NATCEP due to the imposition of a CMP in excess of $5,000 and the
extended survey, as a matter of law.

I have concluded that Petitioner violated 42 C.F.R. §§ 483.13(c)(2) (Tag F225) and
483.25(h) (Tag F323); that the violation of 42 C.F.R. § 483.13(c)(2) posed a risk for more
than minimal harm to one or more facility residents; and that the violation of 42 C.F.R.

§ 483.25(h) posed immediate jeopardy for two days. Ifa 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
per instance CMP 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); 42
C.F.R. § 488.438(a)(2). I conclude that there is a basis for the imposition of a per day
CMP in this case from July 7 through July 26, 2011.

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 (3) 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 non-compliance, including repeated deficiencies; (2) the facility’s financial condition;

32

(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 facility’s 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
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 or 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 12-13; CarePlex of Silver Spring, DAB No. 1683 at 14-18 (1999);
Capitol Hill Comm. Rehab. and Specialty Care Ctr., DAB No. 1629 (1997).

First considering the factors listed in 42 C.F.R. § 488.404(b), I conclude that the
violations of 42 C.F.R. §§ 483.13(c)(2) and 483.25(h) involved a single incident
involving a single resident and the deficiencies are, therefore, isolated. The violation of
42 C.F.R. § 483.13(c)(2) posed a risk for more than minimal harm with no actual harm or
immediate jeopardy, as already discussed. The violation of 42 C.F.R. § 483.25(h) posed
immediate jeopardy but the evidence does not show actual harm, only the likelihood of
serious injury, harm, impairment, or death. Pursuant to 42 C.F.R. § 488.438(f), I find that
both deficiencies were serious. CMS has presented evidence of prior instances of
noncompliance. Petitioner was cited for noncompliance under Tag F323 with no actual
arm or immediate jeopardy in July 2008. Petitioner was previously cited for
noncompliance under Tag F225 in November 2010. CMS Ex. 16 at 1, 10-11. Petitioner
‘as presented no evidence of its financial status or argued that it is unable to pay the
CMP. Petitioner is culpable, particularly regarding the noncompliance under Tag F323
for the reasons already discussed.

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). I conclude that the CMP of $3,650 per day proposed by CMS
for the two days of immediate jeopardy is reasonable. The lower range of CMPs, $50 per
day to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy,
but either cause actual harm to residents, or cause no actual harm but have the potential
for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). I conclude that the

33

$450 per day CMP proposed for the period of noncompliance from July 9 through 26,
2011, is reasonable. Both CMP amounts are at the low-end of the authorized ranges.

The CMP approved in this case exceeds $5,000 and Petitioner was subject to an extended
survey. Therefore, Petitioner was ineligible to be approved to conduct a NATCEP for
two years by operation of law. Because Petitioner had no approved NATCEP at the time
of the survey, no further review is authorized for reasons previously discussed.

III. Conclusion

For the foregoing reasons, I find Petitioner was not in substantial compliance with
program participation requirements from July 7 through 26, 2011, due to violations of 42
CFR. § 483.13(c)(2) and 483.25(h). A CMP of $3,650 per day for July 7 and 8, 2011
and $450 per day for the period July 9 through 26, 2011, a total CMP of $15,400, is a
reasonable enforcement remedy in this case. Petitioner was ineligible to be approved to
conduct a NATCEP for two years by operation of law.

/s/
Keith W. Sickendick
Administrative Law Judge