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

Golden Oaks Medical Care Facility,
(CCN: 23-5260),

Petitioner
v.
Centers for Medicare and Medicaid Services.
Docket No. C-10-272
Decision No. CR2468
Date: December 7, 2011
DECISION

Petitioner, Golden Oaks Medical Care Facility, was not in substantial compliance with
program participation requirements from October 8, 2009 through October 21, 2009.
There is a basis for the imposition of an enforcement remedy. A civil money penalty
(CMP) of $700 per day from October 8, 2009 through October 21, 2009, a total CMP of
$9,800, is a reasonable enforcement remedy.
I. Background
Petitioner, located in Pontiac, Michigan, participates in Medicare as a skilled nursing
facility (SNF) and the Michigan Medicaid program as a nursing facility (NF). On
October 8, 2009, the Michigan Department of Community Health (state agency)

conducted a complaint survey and determined that Petitioner was not in substantial
compliance due to a violation of 42 C.F.R. § 483.25(h)! that caused actual harm to a

' References are to the version of the Code of Federal Regulations (C.F.R.) in effect at
the time of the survey, unless otherwise indicated.
resident. On November 4, 2009, the state agency conducted a revisit survey and
determined that Petitioner returned to substantial compliance on October 22, 2009. The
Centers for Medicare and Medicaid Services (CMS) notified Petitioner by letter dated
January 6, 2010, that it was imposing a CMP of $700 per day for the period October 8,
2009 through October 21, 2009, totaling $9,800. CMS also advised Petitioner that
Petitioner was ineligible to conduct a Nurse Aide Training and Competency Evaluation
Program (NATCEP) for two years due to the amount of the CMP. Parties’ Joint
Stipulation of Undisputed Fact (Jt. Stip.) 4] 1-2, 10-11; CMS Exhibit (CMS Ex.) 1.

On December 14, 2009, Petitioner timely filed a request for hearing before an
administrative law judge (ALJ). On January 6, 2010, this case was assigned to me for
hearing and decision and an Acknowledgement and Prehearing Order was issued on
January 11, 2010. A hearing was scheduled for September 7, 2010, in Detroit, Michigan.
However, on August 19, 2010, Petitioner filed a waiver of oral hearing and requested that
l establish a schedule for briefing and submission of documentary evidence. On August
30, 2010, I accepted Petitioner’s waiver of oral hearing and set a briefing schedule. On
November 4, 2010, Petitioner filed its brief (P. Br.) and Petitioner exhibits (P. Exs.) 1
through 14. On November 5, 2010, CMS filed its brief (CMS Br.) and CMS Exs. 1
through 21. On December 6, 2010, the parties filed their reply briefs (CMS Reply and P.
Reply). CMS did not object to my consideration of P. Exs. 1 through 14 and they are
admitted. Petitioner filed an objection to CMS Ex. 20 on July 23, 2010, on grounds that
it was not timely exchanged and that it presented a danger of unfair prejudice and
confusion of the issues. Petitioner’s objection is overruled. Petitioner does not articulate
any specific prejudice that might occur if I consider the document. Furthermore, CMS
Ex. 20 is not confusing. Petitioner also had the opportunity to offer contrary evidence,
either in the form of documents or testimony. CMS Exs. | through 21 are admitted.

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

The Secretary has delegated to CMS and the states the authority to impose remedies
against a long-term care facility that is not complying substantially with federal
participation requirements. “Substantial compliance means a level of compliance with
the requirements of participation such that any identified deficiencies pose no greater risk
to resident health or safety than the potential for causing minimal harm.” 42 C.F.R.

§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, subpart B. 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.

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 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). “dmmediate jeopardy means a

> 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 the participation requirements established by sections 1919(b), (c), and (d) of the
Act.
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 aresident.” 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).

Petitioner was notified in this case that it was 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 training and competency evaluation program.
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. Part

483, subpart D. Pursuant to 42 C.F.R. §
approve and must withdraw any prior ap
that has been: (1) subject to an extended
1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of t

483.151(b)(2) and (e)(1), a state may not
proval of a NATCEP offered by a SNF or NF
or partial extended survey under sections

e 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 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. The Residence at Salem Woods, DAB No. 2052 (2006);
Cal Turner Extended Care, DAB No. 2030 (2006); Beechwood Sanitarium, DAB No.
1906 (2004); Emerald Oaks, DAB No. 1800, at 11 (2001); Anesthesiologists Affiliated,
DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991). A facility has a right to appeal a
“certification of noncompliance leading to an enforcement remedy.” 42 C.F.R.

§ 488.408(g)(1); 42 C.F.R. §§ 488.330(e), 498.3. However, the choice of remedies, or
the factors CMS considered when choosing remedies, are not subject to review. 42
C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of

noncompliance determined by CMS, if a successful challenge would affect the range of
the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.
42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of
noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is
clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726, at 9,
38 (2000), aff’d, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals Board (the
Board) has long held that the net effect of the regulations is that a provider has no right to
challenge the scope and severity level assigned to a noncompliance finding, except in the
situation where that finding was the basis for an immediate jeopardy determination. See,
e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).
ALJ Review of a CMP is subject to 42 C.F.R. § 488.438(e).

The standard of proof, or quantum of evidence required, is a preponderance of the
evidence. CMS has the burden of coming forward with evidence and making a prima
facie showing of a basis for imposition of an enforcement remedy. Petitioner bears the
burden of persuasion to show by a preponderance of the evidence that it was in
substantial compliance with participation requirements or any affirmative defense.
Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing &
Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v.
Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800; Cross
Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611
(1997), aff'd, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL
34813783 (D.N.J. May 13, 1999).

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

CMS alleges that Petitioner was not in substantial compliance with program participation
requirements from October 8 through 21, 2009, due to a violation of 42 C.F.R. §
483.25(h) (Tag F323), which resulted in an isolated incident of actual harm to a resident
but did not pose immediate jeopardy. The Statement of Deficiencies (SOD) for the
survey that ended on October 8, 2009, cited two examples as support for the deficiency
related to Resident 101 and Resident 102. The parties stipulated and agreed, however,
that CMS is not proceeding upon the example of Resident 101. Jt. Stip. § 4; CMS Br. at
2,n.1; P. Br. at 1-2.

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,
even though not all may be specifically discussed in this decision. I discuss the credible

6

evidence given the greatest weight in my decision-making.’ The fact that evidence is not
specifically discussed should not be considered sufficient to rebut the presumption that I
considered all the evidence and assigned such weight or probative value to the credible
evidence that I determined appropriate within my discretion as an ALJ. There is no
requirement for me to discuss the weight given every piece of evidence considered in this
case, nor would it be consistent with notions of judicial economy to do so.

1. Petitioner violated 42 C.F.R. § 483.25(h).
2. Petitioner’s violation of 42 C.F.R. § 483.25(h) caused actual harm.

3. Petitioner was not in substantial compliance due to its violation of
42 C.F.R. § 483.25(h) from October 8 through 21, 2009.

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

The parties stipulated to the following facts. Jt. Stip., (5-9. Resident 102 was an 83
year old male who was readmitted to the facility on June 13, 2009. On June 13, 2009,
Resident 102 was assessed to be at high risk for falls. CMS Ex. 13, at 57; P. Ex. 8, at 1.
Resident 102’s Minimum Data Set (MDS) completed in June 2009, shows that he had
fallen in the last 30 days and in the last 31 to 80 days. CMS Ex. 13, at 6, 9. Resident 102
was assessed as totally dependent on staff for all activities of daily living (ADLs),
including bed mobility (he required a one person assist) and transfers (he required a two
person assist). CMS Ex. 13, at 8. Resident 102 was assessed as being in unstable
condition and he suffered from cognitive loss, confusion or dementia, contractures, and
pain secondary to the contractures. CMS Ex. 13, at 9, 14-31. On June 16, 2009, at 10:30
a.m., Resident 102 rolled out of his bed and onto a floor mat. CMS Ex. 15, at 1; CMS
Ex. 3, at 4. On June 22, 2009 at 8:00 p.m., Resident 102’s bed alarm sounded and staff
found him on the floor with his head on the floor and his body on the floor mat. Resident
102 suffered a laceration on the back, right side of his head that required multiple
stitches. CMS Ex. 8, at 2-4; CMS Ex. 13, at 60; CMS Ex. 15, at 3-6.

> “Credible evidence” is evidence that is worthy of belief. Black's Law Dictionary 596
(18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Id. at 1625.
The following facts are gleaned from the clinical records for Resident 102 that are in
evidence. On June 15, 2009, two days after the resident’s readmission, a Rehabilitation
Screen was completed that identified the following devices as required or in use:

bilateral floor mats; bed sensor; a hi-low bed; a high-back, reclined wheelchair with anti-
tipper device; and a tab alarm. P. Ex. 9, at 1. A physician’s order for the interventions,
dated and signed on June 17, 2009, substituted a geriatric chair for the high-backed
wheelchair. CMS Ex. 13, at 51, 56. Resident 102’s care plan dated June 16, 2009, listed
as a problem Resident 102’s history of falls and that he was “always throwing [his] lower
extremities over the mattress of his bed due to poor safety awareness.” CMS Ex. 13, at
7; P. Ex. 11, at 1. The care plan cautioned staff to “be mindful that resident will throw
lower extremities over the mattress” and listed the following interventions: assist
resident with turns and repositioning every two hours; assess for orthostatic hypotension;
check for incontinence and change every two hours and as necessary; observe Foley
catheter for placement to avoid discomfort; mechanical lift for all transfers; floor mats on
both sides of bed; bilateral heel protectors while in bed; geriatric chair while up with a tab
alarm; hi-low bed with bed in lowest position except when giving care; and low air
mattress. CMS 13, at 17; P. Ex. 11, at 1. The bed sensor listed as recommended by the
Rehabilitation Screen on June 15, 2009 (P. Ex. 9, at 1), is not listed in the June 16 care
plan. Resident 1 fell from his bed on June 16. CMS Ex. 15, at 1; P. Ex. 10. The
evidence shows additional interventions following the fall from bed on June 16, 2009,
that were not added to the care plan, including: the facility tied down Resident 102’s
mattress more securely to the bed;* applied a bed sensor alarm to Resident 102’s bed, and
arranged for a physical therapy evaluation. CMS Ex. 13, at 51, 59; CMS Ex. 15, at 1; P.
Ex. 4, at 2; P. Ex. 10, at 1.

The Incident and Accident Report for the June 16, 2009 fall shows that the resident rolled
off the bed onto the floor mat. The report does not state that the resident was in a hi-low
bed prior to the fall and, if so, whether it was in the low position. The report also does
not state what other interventions were in use or in place at the time of the fall. CMS Ex.
15, at 1.

Resident 102 fell from his bed again on June 22, 2009, and suffered a laceration on the
back of his head that required stitches. Facility incident and accident reports and
progress notes for the June 22, 2009 fall indicate that staff responded to the resident’s bed
sensor alarm. The reports do not indicate whether the resident’s bed was in the high or
the low position when the fall occurred. The reports do not indicate the size of the floor

* Resident 102’s air mattress was a low air-loss mattress and was an intervention to help
prevent pressure sores. CMS Ex. 13, at 24.
mat or provide any description of the resident’s positioning on the floor mat other than
that his head was on the floor and his body was on the floor mat. P. Ex. 12; CMS Ex. 8,
at 2; CMS Ex. 13, at 60; CMS Ex. 15, at 3, 5-6. After the June 22, 2009 fall from bed,
the facility gave the resident a different mattress; added bolsters on both sides of the bed;
and conducted in-service training of staff regarding fall prevention equipment,
interventions, safety, and positioning. CMS Ex. 8, at 4; CMS Ex. 13, at 15, 22, 52; CMS
Ex. 15, at 3, 6; P. Ex. 4, at 3; P. Ex. 9, at 1; P. Ex. 12. Physician’s orders dated June 23,
2009, required bed bolsters, a low air mattress, and the discontinuation of the vinyl
mattress overlay wings that the facility implemented immediately after the June 22, 2009
fall. CMS Ex. 13, at 2, 5, 50, 52, 56, 60; P. Ex. 9, at 1; P. Ex. 12; P. Ex. 14. Undated
interventions on the care plan to perform neurologic checks and to check incision are
clearly related to the June 22, 2009 fall, as is the intervention to add bolsters on both
sides of the resident’s bed, which is dated June 23, 2009. CMS Ex. 13, at 17; P. Ex. 11,
at 1.

b. Analysis

The general quality of care regulation, 42 C.F.R. § 483.25, requires that a facility ensure
that each resident receives necessary care and services to attain or maintain the resident’s
highest practicable physical, mental, and psychosocial well-being, in accordance with the
resident’s comprehensive assessment and plan of care. The quality of care regulations
impose specific obligations upon a facility related to accident hazards and accidents.

The facility must ensure that —

(1) The resident environment remains as free of accident
hazards as is possible; and

(2) Each resident receives adequate supervision and
assistance devices to prevent accidents

42 C.F.R. § 483.25(h). CMS instructs its surveyors that the intent of 42 C.F.R. §
483.25(h)(1) and (2) is “to ensure the facility provides an environment that is free from
accident hazards over which the facility has control and provides supervision and
assistive devices to each resident to prevent avoidable accidents.” The facility is
expected to: identify, evaluate, and analyze hazards and risks; implement interventions to
reduce hazards and risks; and monitor the effectiveness of interventions and modify them
when necessary. State Operations Manual (SOM), CMS Pub. 100-07, app. PP, Guidance
to Surveyors Long Term Care Facilities, F323 (Rev. 27; eff. Aug. 17, 2007).

The Board has provided interpretative guidance for adjudicating alleged violations of 42
C.F.R. § 483.25(h)(1):
The standard in section 483.25(h)(1) itself - that a facility
“ensure that the environment is as free of accident hazards as
possible” in order to meet the quality of care goal in section
483.25 -- places a continuum of affirmative duties on a
facility. A facility must determine whether any condition
exists in the environment that could endanger a resident's
safety. If so, the facility must remove that condition if
possible, and, when not possible, it must take action to protect
residents from the danger posed by that condition. [Footnote
omitted.] Ifa facility has identified and planned for a
hazard and then failed to follow its own plan, that may be
sufficient to show a lack of compliance with [the]
regulatory requirement. In other cases, an ALJ may need to
consider the actions the facility took to identify, remove, or
protect residents from the hazard. Where a facility alleges (or
shows) that it did not know that a hazard existed, the facility
cannot prevail if it could have reasonably foreseen that an
endangering condition existed either generally or for a
particular resident or residents.

Maine Veterans’ Home — Scarborough, DAB No. 1975, at 6-7 (2005) (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 and
Rehab. - Alamance, DAB No. 2070 (2007); Golden Age Skilled Nursing & Rehab. Ctr.,
DAB No. 2026 (2006); Estes Nursing Facility Civic Ctr., DAB No. 2000 (2005);
Northeastern Ohio Alzheimer’s Research Ctr., DAB No. 1935 (2004); Woodstock Care
Ctr., DAB No. 1726 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th
Cir. 2003). 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 adequate under the circumstances.
Whether supervision is “adequate” depends in part upon the resident’s ability to protect
himself or herself from harm. /d. Based on the regulation and the cases in this area,
CMS meets its burden to show a prima facie case, if the evidence demonstrates that the
facility failed to provide adequate supervision and assistance devices to prevent
accidents, given what was reasonably foreseeable. Alden Town Manor Rehab. & HCC,
DAB No. 2054, at 5-6, 7-12 (2006). An “accident” is an unexpected, unintended event
that can cause a resident bodily injury, excluding adverse outcomes associated as a direct
consequence of treatment or care (e.g., drug side effects or reactions). SOM, app. PP,
Tag F323; Woodstock Care Ctr., DAB No. 1726, at 4.

CMS offered the declaration of Surveyor Denise Young-Bean, R.N., in which she
testifies that she conducted the complaint survey that ended on October 8, 2009, and that
she wrote the Statement of Deficiencies (SOD), which reflects her findings and
conclusions. CMS Ex. 21. Surveyor Bean alleges in the SOD, based on record review
and interviews, that Petitioner violated 42 C.F.R. § 483.25 because Petitioner failed to
provide Resident 102 adequate supervision to prevent accidents, one of which resulted in
actual harm. CMS Ex. 3, at 1-2; P. Ex. 1, at 1-2. Surveyor Bean alleges in her
declaration that Petitioner failed to provide Resident 102 adequate supervision and
assistance devices prior to the June 16 fall to prevent Resident 102 from falling from bed.
Surveyor Bean alleges that Petitioner’s interventions were also inadequate prior to the fall
from bed on June 22, 2009. CMS Ex. 21, at 4-6. Surveyor Bean opines that Petitioner
could have increased the resident’s supervision by implementing 15 or 30 minute checks,
moving him to a room closer to the nurse’s station or another more readily accessible
location, or implementing a sitter program. She also alleges that there is no evidence that
Petitioner assessed the cause for Resident 102 throwing his legs over the mattress, which
she apparently considered a contributing factor to both falls. Although not specifically
stated, Surveyor Bean’s allegations clearly suggest that she also considered that Petitioner
not only failed to assess the cause of the behavior, but also failed to implement
interventions to address the behavior prior to the fall on June 22. Surveyor Bean also
commented that the effectiveness of an alarm is dependent upon how quickly staff can
respond to prevent an accident. She alleged that Resident 102’s behavior of throwing his
legs over his mattress was known to Petitioner and it was foreseeable that the resident
would throw his legs out of bed and fall before staff could respond to a sounding alarm.
CMS Ex. 21, at 6.

There is no dispute that Petitioner assessed Resident | as at risk for falls on June 13,
2009, and implemented some interventions to address that risk. There is no dispute that
Resident 102 fell from bed on June 16, 2009 and again on June 22, 2009. There is no
dispute that Resident 102 suffered actual harm as a result of the June 22 fall when his
head hit the floor, in the form of a laceration on his head that required stitches. I
conclude that CMS has made a prima facie showing of noncompliance due to a violation
of 42 C.F.R. § 483.25(h) that resulted in actual harm to Resident 102. Thus, the burden
of proof and persuasion is upon Petitioner to rebut the prima facie case or to establish an
affirmative defense. I conclude, after consideration of all the evidence of record and the
arguments of the parties, that Petitioner has failed to rebut the prima facie showing or to
establish an affirmative defense.

The evidence shows that upon his readmission to the facility on June 13, 2009, Petitioner
assessed the resident as being at risk for falls. Thus, it was clearly foreseeable that the
resident could fall from bed or his wheelchair. The resident’s care planning team planned
multiple interventions to address the fall-risk. The evidence shows that the resident also
had the behavior of throwing his legs over the side of his mattress. The evidence shows
that the behavior was recognized as contributing to the risk of the resident falling from
bed. Petitioner has presented no evidence that there was an attempt to identify the cause
for the behavior or to control the behavior to reduce the risk for falls from bed.

On June 16, 2009, Resident 102 fell from his bed. Petitioner’s accident report shows that
it was determined the resident rolled off his bed. In response to the accident, Petitioner
tied down the resident’s mattress more securely to the bed, implemented a bed sensor
alarm to alert staff if the resident was exiting the bed, and ordered a physical therapy
evaluation. Petitioner argues that its interventions following the June 16 fall were
adequate. Petitioner’s Prehearing Brief (P. Ph. Br.) at 7; P. Br. at 11; P. Reply at 4-5.
Petitioner provides no evidence to explain why the mattress was not secured tightly to the
bed frame in accordance with manufacturer’s instructions prior to the June 16 fall.
Petitioner does not explain why no bed sensor alarm was in place prior to the June 16 fall.
Petitioner also submitted no evidence that the care planning team assessed the
effectiveness of any of the interventions in place at the time of the fall. Petitioner has not
shown that the resident was in the hi-low bed or that the bed was in the low position
when he fell. Petitioner presented no evidence that the care planning team considered
additional or different interventions, including more restrictive interventions such as side
rails or bolsters to prevent falls.

On June 22, 2009, Resident 102 fell again. Petitioner has presented no evidence that the
care planning team determined the cause of the fall, what interventions were in use at the
time of the fall, or whether the interventions were effective to reduce the risk for
accidental injury of the resident. The evidence does show the bed sensor alarm was
effective to alert staff that the resident was falling or had fallen. But clearly, the alarm
did not prevent the fall or the injury. There is no evidence that Petitioner assessed
whether the alarm might be more effective if the resident was in a different room where
staff could respond more quickly, or whether he required closer supervision to permit a
quicker response to prevent a fall from his bed or his wheelchair. There is no evidence
that the care planning team assessed whether the resident’s bed was in the low position at
the time of the fall or whether the floor mats were adequately sized and positioned to
prevent his head from striking the floor or furniture when he rolled or fell from bed.
There is no evidence that the care planning team assessed the effectiveness of alternative
interventions including restrictive interventions, other than the physician ordered bed
bolsters, a different mattress, and discontinuation of the use of the mattress wings.

Petitioner advances several arguments for why it should be found in compliance or why
its noncompliance should be excused.
Petitioner argues that the previous history of falls may not have all been from Resident
102’s bed and that Resident 102’s high risk for falls may not have been limited to falls
from his bed. P. Br. at 9-10; P. Reply at 3-4. This argument is no defense. Petitioner
clearly knew that Resident 102 was at risk to fall from his bed before the June 16 fall, as
Petitioner had planned interventions to address the risk for such falls. Petitioner fails,
however, to show: that the interventions were actually implemented; that their
effectiveness was evaluated, particularly after the fall on June 16; and that the care
planning team considered alternatives.

Petitioner argues that Resident 102 was totally dependent on staff for mobility and “was
not a resident who would be expected to move about or out of his bed quickly.”
Therefore, Petitioner asserts that the bed sensor alarm was a reasonable intervention and
adequate under the circumstances. Petitioner argues that its staff responded promptly to
the alarm. P. Br at 11-12; P. Reply at 5-7. The bed sensor alarm clearly alerted
Petitioner’s staff that Resident 102 was getting out of bed, and it was effective for that
purpose. A bed sensor alarm is not effective to prevent a fall or related injury when a
resident falls attempting to get out of bed, unless there is also some increased supervision
so that staff can get to the resident prior to the fall. Petitioner, however, did not increase
its supervision of Resident 102. Therefore, a bed sensor was not an adequate and
reasonable intervention, by itself, particularly given this resident’s leg throwing behavior.
The hi-low bed and floor mats are reasonable interventions to minimize or totally prevent
accidental injury from a fall, but only if properly implemented. Petitioner has not shown
that the interventions of a hi-low bed and floor mats were properly implemented at the
time of either fall.

Petitioner argues that it did not adopt the intervention of bed bolsters until after the June
22 fall because bed bolsters are a form of restraint like bed side rails, and Petitioner
wanted to try a less restrictive intervention first. Petitioner argues that a bed alarm is a
reasonable alternative to a restraint and that it balanced the amount of the restraint in light
of the potential risk of harm. Petitioner argues, inconsistently, that Resident 102 was
totally dependent on staff for bed mobility but also argues that it did not want to restrict
Resident 102’s freedom of movement by using bed bolsters. P. Ph. Br. at 7-10; P. Br. at
12-16; P. Reply at 7-11. Whether or not the bed bolster is a restraint is not the issue. The
issue is whether Petitioner has shown that it took all reasonable steps to protect the
resident from injury due to accidental falls from his bed. Even if a bed bolster is
considered a restraint, the use of restraints is clearly permissible under statutory and
regulatory participation requirements so long as criteria are met. Ensuring the physical
safety of the resident is an authorized purpose for the use of restraint. Act §§
1819(c)(1)(A)(ii), 1919(c)(1)(A)(ii); 42 C.F.R. § 483.13(a). Petitioner has not presented
any evidence that bolsters, side rails, or other restraints were considered by the care
planning team prior to either fall, despite the fact that Petitioner was clearly on notice that
Resident 102 threw his legs over the mattress and recognized that such behavior could
result in a fall.
I conclude that Petitioner has failed to show that it took all reasonable steps to ensure that
Resident 102 received supervision and assistance devices to meet his assessed need for
prevention of falls and to mitigate the foreseeable risks of harm to him secondary to
accidental falls from his bed or wheelchair. Accordingly, I conclude that Petitioner has
failed to rebut the CMS prima facie case or to establish an affirmative defense.

5. A CMP of $700 per day from October 8, 2009 through October 21,
2009 is reasonable.

Ihave concluded that Petitioner violated 42 C.F.R. § 483.25(h) and that the violation
caused actual harm to Resident 102. Thus, Petitioner was not in substantial compliance
with program participation requirements, and there is a basis to impose an enforcement
remedy. 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. 42 C.F.R. § 488.430(a). Petitioner has not argued or
shown that it returned to substantial compliance prior to October 21, 2009. Authorized
CMPs are divided into two ranges. The lower range is from $50 to $3,000 per day and is
authorized for noncompliance that does not pose immediate jeopardy but has the potential
for more than minimal harm. 42 C.F.R. §§ 488.408, .438(a)(1)(i), (d)(2). The lower
range is applicable in this case.

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;
(3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same
factors CMS and/or the state were to consider when setting the CMP amount; and (4) the
facility’s degree of culpability, including but not limited to the facilities neglect,
indifference, or disregard for resident care, comfort, and safety. 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 and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are

widespread. My review of the reasonableness of the CMP is de novo and based upon the
evidence in the record before me. I am not bound to defer to the CMS determination of
the reasonable amount of the CMP to impose but my authority is limited by regulation as
already explained. I am to determine whether the amount of any CMP proposed is within
reasonable bounds considering the purpose of the Act and regulations. Emerald Oaks,
DAB No. 1800, at 10; CarePlex of Silver Spring, DAB No. 1683, at 14-16 (1999);
Capitol Hill Cmty. Rehab. and Specialty Care Ctr., DAB No. 1629 (1997).

Petitioner was cited for noncompliance under Tag F323 in two survey cycles occurring
within the ten months prior to the survey at issue. A May 19, 2009 complaint and annual
survey cited Petitioner for noncompliance under Tag F323 that caused actual harm.
Petitioner was also cited for noncompliance under Tag F323 that resulted in actual harm
by a February 19, 2009 complaint survey. CMS Ex. 19, at 1. The noncompliance under
Tag F323 in the present survey was serious, as it caused actual harm to Resident 102,
which required a trip to the hospital and multiple sutures for his laceration. CMS Ex. 8,
at 4; CMS Ex. 13, at 60; CMS Ex. 15, at 3. Petitioner has not alleged an inability to pay
the CMP imposed or presented evidence to support such an allegation. The evidence
supports a conclusion that Petitioner was culpable because the evidence does not show
that the care planning team assessed the need for interventions, whether interventions
were implemented, and whether interventions implemented were effective. Petitioner
also failed to assess Resident 102’s leg throwing behavior and to adopt interventions to
limit or prevent the behavior, even though Petitioner was clearly aware of this behavior.
Lalso note that the CMP is at the low end of the range of authorized CMPs. I conclude,
based upon my consideration of the required factors, that a CMP of $700 per day from
October 8, 2009 through October 21, 2009, is a reasonable enforcement remedy.

II. Conclusion

For the foregoing reasons, Petitioner was not in substantial compliance with program
participation requirements from October 8, 2009 through October 21, 2009. A CMP of
$700 per day from October 8, 2009 through October 21, 2009, totaling $9,800, is a
reasonable enforcement remedy.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Autumn Ridge Rehabilitation Centre,
Petitioner
v.
Centers for Medicare and Medicaid Services.
Docket No. C-11-296
Decision No. CR2467

Date: November 23, 2011

DECISION

I sustain the determination of the Centers for Medicare and Medicaid Services (CMS) to
impose the following remedies against Petitioner, Autumn Ridge Rehabilitation Centre:

¢ Civil money penalties of $3,550 per day for each day of a period beginning on
November 4, 2010 and running through December 13, 2010;

¢ Civil money penalties of $100 per day for each day of a period beginning on
December 14, 2010 and continuing through January 6, 2011;

e Denial of payment for new admissions for each day of a period beginning on
December 23, 2010 and running through January 6, 2011;

e Loss of authority to conduct a nurse aide training and certification program
(NATCEP); and

e Directed in-service training.
I premise my decision on findings that Petitioner failed to comply substantially with
Medicare participation requirements throughout the periods of time during which
remedies are imposed. In particular, I find that Petitioner manifested immediate jeopardy
level noncompliance with the requirements of 42 C.F.R. § 483.25(k) from November 4,
2010 through December 13, 2010. This regulation requires, among other things, that a
facility assure that each resident who has a tracheostomy receive proper management and
care of that condition and that each resident in need of tracheal suctioning receives it.

I. Background

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

Petitioner requested hearings to challenge the remedy determinations that I describe in
the opening paragraph of this decision. The requests were consolidated at my direction.
The parties filed pre-hearing briefs and proposed exhibits that included the written direct
testimony of their proposed witnesses. CMS then moved for summary judgment. I
denied that motion, finding that there were disputed issues of material fact. I
subsequently held a hearing by video conference, on September 22, 2011, and by
telephone, on September 27, 2011. The parties filed post-hearing briefs.

I received into evidence from CMS exhibits consisting of: CMS Exhibits (Ex.) 1 — 18; 21
— 23; 30 — 32; 35 — 37; 39- 42; 46 and 47; 55 — 68; and 73 — 96. I received into evidence
from Petitioner exhibits consisting of P. Ex. 1 — 3. Petitioner attached two additional
documents that it styled “exhibits” to its post-hearing brief. Exhibit A consists of
excerpts from CMS’s State Operations Manual. It is part of the public record, and it is,
therefore, unnecessary that I decide whether to receive it into evidence. Exhibit B is a
notice letter that CMS sent to another skilled nursing facility in February 2011. This
exhibit is irrelevant, and, moreover, Petitioner filed it untimely if it is offering the exhibit
as evidence. I exclude it for these reasons.

IL. Issues, Findings of Fact, and Conclusions of Law
A. Issues
The issues in this case are whether:

1. Petitioner failed to comply substantially with Medicare participation
requirements;
2. CMS’s determination of immediate jeopardy noncompliance is clearly
erroneous; and

3. CMS’s remedy determinations are reasonable.

In addressing these issues, I note that there were multiple surveys of Petitioner’s facility
in the latter part of 2010 and the early part of 2011. These included surveys that were
completed on September 23, 2010 (September Survey), November 16, 2010 (November
Survey), December 14, 2010 (December Survey), and January 7, 2011 (January Survey).
Noncompliance findings were made at all of these surveys except at the January Survey,
at which Petitioner was found to have attained compliance with Medicare participation
requirements.

Petitioner opted not to offer evidence or argument challenging the noncompliance
findings made at the September and November Surveys and challenged only one of the
findings of noncompliance made at the December Survey, the finding of immediate
jeopardy level noncompliance with 42 C.F.R. § 483.25(k). The other findings of
noncompliance made at the September, November, and December surveys are, therefore,
administratively final.

I find it unnecessary to address these administratively final findings of noncompliance
except to the extent that they support the imposition of remedies by CMS. Moreover, the
immediate jeopardy level noncompliance with the requirements of 42 C.F.R. § 483.25(k)
found at the December Survey is, by itself, sufficient to justify all of the remedies that are
at issue here.

B. Findings of Fact and Conclusions of Law
I make the following findings of fact and conclusions of law (Findings).

1. Petitioner failed to comply substantially with the requirements of 42
CF.R. § 483.25(k).

The evidence unequivocally establishes that Petitioner failed to give three of its residents
— identified as Residents B, C, and D — necessary care to address problems related to the
residents’ tracheostomies. In particular, Petitioner’s staff failed to suction the residents’

tracheostomies to prevent them from becoming occluded or to remove mucus.

There was systemic noncompliance by Petitioner’s staff with requirements for basic
tracheostomy care. Each of the three residents whose care is at issue had tracheostomies.
At least two of these residents, Residents B and C, had serious and recurring
complications related to their tracheostomies. These residents suffered from occlusions
and mucus plugs that required suctioning to make it possible for the residents to breathe
freely. Petitioner’s staff failed consistently to provide these residents and Resident D, as
well, with the care and suctioning that they needed.

Resident B lived at Petitioner’s facility for a two-month period, from September 25, 2010
until November 25, 2010, when he was transferred to a hospital and then, to another
nursing facility. During these two months, the resident was hospitalized four times for
problems related to breathing and/or obstruction of his tracheostomy site. CMS Ex. 84,
CMS Ex. 96 at 5—9. This resident obviously had severe problems associated with his
tracheostomy, and these problems were clearly well known to Petitioner’s staff. But, the
staff never prepared a care plan to address the resident’s tracheostomy or to define
measures that the staff would take to make sure that the resident’s airway remained
patent. Thus, the resident’s care plan directed Petitioner’s staff to observe the resident’s
tracheostomy stoma site for possible congestion and to observe the resident for symptoms
of infection. CMS Ex. 84 at 73. But, it recited neither prophylactic treatments nor
interventions in the event that problems developed, except to say that that the resident
should receive medications and oxygen as ordered. Jd.

On more than one occasion, physicians outside of Petitioner’s facility ordered that the
resident receive suctioning to keep his air passage clear. On each of these occasions,
Petitioner’s medical director ordered that the suctioning order be discontinued. The
consequence was that Resident B almost never received suctioning, despite orders from
outside physicians that he receive it, and Petitioner never evaluated or addressed the
implications of this failure to provide care to the resident. Thus:

e In September 2010, as of his admission to Petitioner’s facility, Resident B had an
order for suctioning on a PRN basis. CMS Ex. 84 at 61. On September 29, 2010,
Petitioner’s staff suctioned the resident. Jd. at 62. Then, and without explanation,
the order for suctioning was discontinued. Id. at 61.!

e The resident was brought to the emergency room on October 7, 2010, suffering
from acute pneumonia and acute hypoxia (shortness of breath). CMS Ex. 84 at 1-
2. The treatments he received included suctioning of his trachea. Id. at 5.

¢ On October 31, 2010, Resident B was brought to the emergency room at a local
hospital suffering from shortness of breath. It was determined that his breathing
was impaired by a large mucus plug. CMS Ex. 84 at 3. The resident was later
discharged with orders that he be suctioned four times daily. Jd. at 37. On
November 1, 2010, just one day later, Petitioner’s medical director, James P.
McCann, M.D., ordered that the suctioning be discontinued. His order provides
no explanation for discontinuing the resident’s suctioning. /d. at 31.

' The order to discontinue suctioning is memorialized by the expression “D/C” in the
resident’s medication administration record. CMS Ex. 84 at 61.
e Resident B was again admitted to the hospital on November 7, 2011, suffering
from acute exacerbation of his chronic breathing problems. CMS Ex. 84 at 8-9.
He was treated and released back to Petitioner’s facility on November 10, 2011.
His discharge orders included a directive that he receive tracheal suction on a PRN
basis. Id. at 32. But, on that date, Dr. McCann ordered that suctioning be
discontinued “due to facility policy.” Jd. at 33. The next day, November 11,
2010, he wrote a progress note that contained this statement:

The nurses are restricted by nursing home policies and are not
allowed to suction . . . [Resident B’s] pharynx. He has a
tracheostomy. Unfortunately, they can’t directly clean it out.

Id. at 40.

So, Resident B’s orders for suctioning his tracheostomy were discontinued for
unarticulated policy reasons. A consequence was that the resident, despite being assessed
repeatedly as needing suctioning, never received it. No one at Petitioner’s facility,
neither Dr. McCann nor the staff, ever really explained the clinical reasons for
countermanding the orders issued by hospital based physicians for suctioning.
Petitioner’s records are devoid of any explanation for Petitioners’ policy not to provide
suctioning to residents who had been assessed outside of the facility as needing that
service.

This pattern of consistently failing to provide residents with suctioning or
countermanding orders that residents receive suctioning, and consistently failing to
explain why suctioning was not provided, repeats with Residents C and D. Resident C,
like Resident B, had a tracheostomy but had no plan of care that addressed how to assure
that the resident’s airway remain open and free of mucus. CMS Ex. 96 at 3-4. And, also
like Resident B, Resident C suffered from breathing problems related to congestion that
required her to be treated at a local hospital. She was discharged back to Petitioner’s
facility with orders that she receive routine tracheal care and suctioning. CMS Ex. 86 at
1-3, 26, 32, 36. Not only were these orders not complied with by Petitioner’s staff but
Dr. McCann countermanded an order that the resident receive suctioning. Jd. at 19. He
provided no explanation for countermanding the suctioning order, and, in fact,
Petitioner’s staff performed no assessment of Resident C showing that she did not need
suctioning.

Resident D also had a tracheostomy. The resident had an order in her records for
suctioning but, as with Residents B and C, had no care plan addressing her tracheostomy
or the means by which Petitioner’s staff would attempt to keep her airway open. CMS
Ex. 96 at 4-5. The resident’s record is devoid of any evidence showing either that she
ever received suctioning or that the staff assessed her and determined that suctioning was
not needed.

6

The picture presented of all three residents is of individuals with medical conditions that
demanded that Petitioner and its staff either provide specified medical care (tracheal
suctioning) or to explain, in the course of assessing these residents and planning for their
care, why such care was not necessary. Petitioner and its staff did neither. The
inescapable conclusion is that these residents’ needs were simply ignored by Petitioner
and its staff. Moreover, in revoking explicit physicians’ orders that residents receive
tracheal suctioning, Petitioner’s medical director, Dr. McCann, went beyond ignoring
these residents’ needs, he actively countermanded treatment that had been ordered for the
residents without offering a coherent explanation for doing so.

In addressing the issue of noncompliance Petitioner attempts to reduce this case to a
contest between Dr. McCann and Deann Mankell, R.N., the surveyor who was
responsible for reviewing Petitioner’s records and making on-site observations relevant to
the finding of noncompliance with the requirements of 42 C.F.R. § 483.25(k). Petitioner
asserts that Dr. McCann’s qualifications as a physician, and his personal knowledge of
the residents whose care is at issue, trump Ms. Mankell’s findings and observations.
Essentially, Petitioner contends that any opinion that Ms. Mankell might have about the
inadequacy of care that Petitioner gave to its residents with tracheostomies is
overwhelmed by Dr. McCann’s allegedly far more authoritative opinion.

But, this case is not a case that depends on the conclusions of dueling medical
professionals. There is a regulatory requirement stated in 42 C.F.R. § 483.25(k) that
residents of skilled nursing facilities who have tracheostomies receive necessary care to
address any problems that they might encounter. All three of these residents were
diagnosed as having tracheostomies that were susceptible to occlusion, and, in fact, two
of them had repeated problems that were at least in part related to occluded
tracheostomies. Under those circumstances, Petitioner had an absolute duty to these
residents to provide tracheostomy care including suctioning as was necessary. And,
Petitioner’s medical director and professional staff had a duty to explain and to justify
any decision on their part not to suction residents with tracheostomies.

Suctioning was presumptively necessary in the case of all three residents because each of
them came to the facility with a physician’s order that he or she receive suctioning, either
according to a schedule or as needed. Certainly, it is possible that, after careful
assessment and review of a resident’s condition, Dr. McCann and Petitioner’s staff could
decide that in an individual case suctioning was not needed, even if another physician
thought that suctioning was needed. But, there is no evidence here that Dr. McCann or
Petitioner’s professional staff did any — much less careful — assessment of these resident’s
conditions. The clinical records for these residents are devoid of such assessments. The
residents have no care plans addressing their tracheostomies. There is no commentary
concerning the problems that these residents were or might be encountering. And, Dr.
McCann provided no clinical analysis whatsoever for his orders countermanding other
physicians’ orders that the residents be suctioned.

Dr. McCann’s only contemporary explanation for countermanding orders that residents
be suctioned was that, “unfortunately,” Petitioner’s professional staff was not allowed to
perform suctioning due to some inchoate facility policy. CMS Ex. 84 at 40. That is
hardly a justification for countermanding orders issued by physicians outside of the
facility based on the clinical conditions of the residents in question.

Now, Dr. McCann contends that he erred in concluding that suctioning was prohibited by
facility policy. P. Ex. 1 at 3-4. He contends that he erred as a consequence of receiving
incorrect information from Petitioner’s former director of nursing. /d. But, Dr. McCann
has been Petitioner’s medical director for about 29 years. Tr. at 6-7 (Sept. 27, 2011). Dr.
McCann is personally responsible in his role of medical director for implementation of
resident care policies and the coordination of medical care for residents of the facility. 42
C.F.R. § 483.75(i). Dr. McCann also is personally responsible in his capacity as medical
director for assuring that each resident receives the medical care that he or she needs.
Moreover, he served as the treating physician for Residents B, C, and D. In that capacity,
he also bore personal responsibility for assuring that these residents received needed care.

Given that, I cannot comprehend why Dr. McCann simply would accept the statement of
a nurse on Petitioner’s staff that there was a facility policy barring suctioning of
residents. He was certainly derelict in performing his duties to these residents if he
simply accepted that statement and, based on his acceptance, countermanded orders that
these residents be suctioned.

More likely, however, there was a facility policy not to suction residents. That is the
inference that I draw. The existence of such a policy plausibly explains why: none of the
residents received suctioning, despite orders that they be suctioned; Dr. McCann
countermanded orders for suctioning from physicians from outside the facility almost as
soon as residents were admitted; and no analysis, assessment, or care planning was done
by Dr. McCann or Petitioner’s professional staff concerning whether these residents
needed suctioning. Above all, the existence of a policy barring suctioning explains why
at least one Resident, Resident B, was not suctioned despite experiencing multiple
incidences of congestion requiring hospital care, and despite receiving multiple
physicians’ orders that he be suctioned while at Petitioner’s facility. 7

* My conclusion that Petitioner’s policy was not to suction its residents also finds support
in the comments of clinicians who dealt with Petitioner. A hospital treatment note made
during Resident B’s hospital stay in the first week of October, during which suctioning
was performed at the hospital, reads:

He has had a tracheostomy for cancer of larynx in the past; occasionally
needed suctioning which the nursing home is not able to provide.

CMS Ex. 84 at 14 (emphasis added).
In fact, Petitioner was derelict whether or not there was a policy not to suction residents.
Petitioner owed a duty of care to each resident with a tracheostomy to assure that the
resident received necessary care. Failure to provide such care to Residents B, C, and D,
either as a consequence of facility policy, or as a consequence of neglect, is a regulatory
violation.

Dr. McCann also testified that none of the residents whose care is at issue actually needed
suctioning. For example, Dr. McCann asserts that Resident B would not have benefited
from suctioning. P. Ex. 1 at 2-3. His thesis is that the conditions that the resident
suffered from were not ameliorated by suctioning. Jd. He asserts also that Petitioner’s
then-director of nursing “deemed it unsafe — in her professional judgment — to continue
suctioning given . . . [Resident B’s] numerous complex diagnoses.” Jd. But, Dr. McCann
does not point to even one contemporaneous clinical assessment that would arguably
support these assertions. He references no assessments, no physicians’ orders, no plans
of care. He does not cite any written assessment by the former director of nursing
addressing the costs and benefits of suctioning Resident B. Nor does he point to any
record of communications between himself and the former director of nursing. So, Dr.
McCann’s testimony consists entirely of post hoc rationalizations and naked assertions
that are unsupported by clinical evidence. | find it to be not credible and obviously self-
serving.

I also find it to be not credible because it is belied by clinical evidence that does exist.
Resident B was treated at the hospital several times during his stay at Petitioner’s facility.
The treatments that Resident B received while at the hospital included suctioning. CMS
Ex. 84 at 5. There is, thus, credible clinical evidence that the resident not only needed
suctioning but that he benefited from it. And, consistent with that evidence are the
several orders from hospital-based physicians that the resident be suctioned after his
discharge from the hospital.

2. CMS’s determination of immediate jeopardy level noncompliance is
not clearly erroneous.

The term “immediate jeopardy” is defined to mean noncompliance that is so grave as to
cause, or to be likely to cause, serious injury, harm, impairment, or death to a resident.
42 C.F.R. § 488.301. Where there is noncompliance and a determination of immediate
jeopardy, the facility has the burden of proving that determination to be clearly
erroneous.

Here, there is overwhelming evidence to support CMS’s determination that Petitioner’s
noncompliance with the requirements of 42 C.F.R. § 483.25(k) was so egregious as to
constitute immediate jeopardy for Petitioner’s residents. And, even if that were not so,
Petitioner plainly did not prove CMS’s determination of immediate jeopardy to be clearly
erroneous.
Residents B, C, and D are individuals who were found by physicians who are
independent of Petitioner’s facility to need suctioning of their tracheostomies. Yet, none
of these residents had care plans that provided interventions for protecting them from
problems that might arise respecting their tracheostomies, or for treating any problems
that did arise. On numerous occasions, the orders for suctioning of these residents were
countermanded without any coherent explanation for doing so. As a consequence, these
residents were at risk for developing obstructions to their tracheostomies and for
compromised breathing. CMS Ex. 96 at 5. The likelihood of harm to these residents
from such complications and from lack of tracheostomy care was substantial. Indeed,
that is why regulations explicitly require a facility to provide tracheostomy care to any
resident who has a tracheostomy. 42 C.F.R. § 483.25(k).

Moreover, the evidence supports a conclusion that at least one Resident, Resident B, was
seriously harmed by Petitioner’s failure to provide prophylactic care and treatment of his
tracheostomy. Resident B was sent to the hospital to address respiratory issues four times
during his brief stay at Petitioner’s facility. On one occasion, hospital staff found it
necessary to suction the resident, performing the precise treatment that Petitioner refused
to perform. CMS Ex. 84 at 5.

Petitioner argues that the determination of immediate jeopardy ignores several critical
facts that mitigate in favor of a finding that the determination is clearly erroneous. First,
Petitioner argues that Resident B had frequently gone on leave from the facility without
receiving humidified oxygen while off-premises. It contends that the respiratory
problems that the resident experienced in October and November 2010 were not the
consequence of deficient care by Petitioner but, rather, were caused by the resident’s
frequent off-premises trips and his lack of access to humidified oxygen. Petitioner’s
Post-Hearing Brief at 5-6.

That argument is no defense. While it is certainly possible that the resident’s respiratory
problems were exacerbated by his off-premises trips, that does not relieve Petitioner of its
responsibility to provide care for him. Petitioner’s obligation to provide tracheostomy
care to the resident is undiminished by the possibility that the resident’s off-premises
trips were making his problems worse. The failure by Petitioner’s staff to suction the
resident meant that the adverse consequences of the resident’s trips, including increased
congestion, occlusion, and breathing difficulties, were not addressed. The likelihood of
harm, therefore, was exacerbated not only by the resident’s stays away from the premises
but Petitioner’s failure to address the consequences of those stays.

Petitioner also asserts that Resident B suffered from other conditions — such as gastric
reflux disease — that could have caused the resident to suffer from increased secretions
and resulting problems associated with his tracheostomy. Assuming that to be true, I can
identify no basis for this argument to refute CMS’s determination of immediate jeopardy.
Petitioner’s obligations to provide appropriate tracheostomy care to the resident were

only heightened by the resident’s medical conditions that put him at risk for
tracheostomy-associated complications. The failure of Petitioner to provide
tracheostomy care to Resident B in the face of complicating conditions does not mitigate
against a finding of immediate jeopardy; rather, it supports such a finding.

Petitioner next argues that Dr. McCann’s testimony stands unimpeached, in light of the
failure of CMS’s counsel to cross examine him extensively. Petitioner’s Post-Hearing
Brief at 7-9. I disagree. I have explained at Finding 1 why I find Dr. McCann’s
testimony to be self-serving and not credible.

Petitioner also attempts to rebut a survey finding that Petitioner had failed to provide
Resident D with access to suctioning equipment. | find it unnecessary to address this
issue. As I have stated, evidence showing immediate jeopardy level noncompliance is
very strong. Whether or not Resident D had access to suctioning equipment would not
change my finding as to the issue of immediate jeopardy.

Next, Petitioner attempts to attack the surveyor who conducted the December Survey for
relying too heavily on documents and facility records. It contends that the survey results
were flawed fatally because the surveyor did not attempt to interview or observe Resident
B. According to Petitioner, the surveyor relied too heavily “on hearsay evidence —
Resident B’s records — without observing the resident’s physical condition.” Petitioner’s
Post-Hearing Brief at 10-11.

I find this argument to be without merit. The clinical records relied on by the surveyor
and offered by CMS as evidence are more than sufficient proof, both of noncompliance
by Petitioner and of the likelihood of serious harm or worse that was caused by that
noncompliance. I have discussed that evidence in detail in this decision; it is more than
enough to shift the burden to Petitioner to rebut it with affirmative proof of its own. For
the reasons I have discussed, Petitioner failed to rebut that evidence. Furthermore, the
records that CMS offered were not, Petitioner’s contention notwithstanding, mere
“hearsay,” they were records generated by Petitioner’s own staff of the care that they
provided (or failed to provide) to its residents, including Resident B. Petitioner had it
within its power to explain those records, if there was any explanation for them other than
the one that CMS advocated. It failed to do so.

Finally, Petitioner has offered nothing to show that observation of Resident B would have
changed the outcome of this case in the slightest.

3. CMS’s remedy determinations are reasonable.
The remedies that CMS determined to impose consist of civil money penalties and other

remedies that are authorized for noncompliance with participation requirements. The
non-monetary remedies that CMS determined to impose include directed in-service
training of staff, denial of payment for new Medicare admissions, and loss of authority to
conduct NATCEP. Petitioner has challenged none of these non-monetary remedies.
Consequently, I find no need to address them here, except to find that Petitioner’s
noncompliance with the requirements at 42 C.F.R. § 483.25 at the immediate jeopardy
level beginning on November 4, 2010 and continuing through December 13, 2010, its
non-immediate jeopardy level noncompliance with that regulation from December 14,
2010 through January 6, 2011, and its non-immediate jeopardy level noncompliance with
other regulations beginning prior to November 4, 2010 and running through January 6,
2011 are grounds to sustain all of the non-monetary remedies that CMS imposed.

There is also ample basis to sustain the amount and duration of the civil money penalties.

a. Civil money penalties of $3,550 for each day of the November 4
through December 13, 2010 period are reasonable.

Daily civil money penalties to remedy immediate jeopardy level noncompliance must fall
within a range of from $3,000 to $10,000 per day. 42 C.F.R. § 488.438(a)(1)(i). Any
decision as to where within that range a penalty amount ought to fall depends on
evidence that relates to regulatory factors that are specified at 42 C.F.R. §§ 488.438(f)(1)
— (4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). These
factors may include: the seriousness of a facility’s noncompliance; its compliance
history; its culpability; and its financial condition.

The immediate jeopardy level civil money penalties of $3,550 per day that CMS
determined to impose are reasonable. The penalty amount lies close to the bottom of the
immediate jeopardy level civil money penalty range. That penalty amount is amply
justified by the seriousness of Petitioner’s noncompliance and also by its culpability. As
I have discussed, there was dereliction by Petitioner of its duty to provide tracheostomy
care to Residents B, C, and D, thereby creating a likelihood of serious harm for these
residents. That dereliction was either a consequence of Petitioner’s policy not to provide
such care or a consequence of Petitioner’s staff’s indifference to the needs of the
residents. In either case, Petitioner’s culpability for its noncompliance was high.

Petitioner has not challenged the duration of its immediate jeopardy level noncompliance
by offering proof that it abated that noncompliance on a date that is earlier than
December 13, 2010. Rather, it contends that CMS’s determination of duration of
immediate jeopardy is “arbitrary” and “capricious.” Petitioner’s Post-Hearing Brief at
14-15. To support this contention, Petitioner argues that there was no direct surveyor
observation of Petitioner’s facility during the 40-day period that CMS determined
immediate jeopardy to persist.

This argument is incorrect as a matter of law because it improperly attempts to shift the
burden of proof of correction of noncompliance from Petitioner to CMS. The burden is
not on CMS to prove that immediate jeopardy was ongoing during this 40-day period.
Rather, the burden lies entirely on Petitioner to prove that it abated its immediate
jeopardy level noncompliance at an earlier date than that which was determined by CMS.

Petitioner failed to offer any evidence proving that it abated immediate jeopardy prior to
December 13. It did not, for example, offer evidence showing that it had reformed its
care procedures for residents with tracheostomies during this period.

Petitioner argues that the civil money penalties are unreasonable because it has no history
of repeated deficiencies relating to tracheostomy care. That may be so, but, as I have
discussed, the seriousness of Petitioner’s noncompliance and its culpability, coupled with
the fact that the penalties are at the low end of the immediate jeopardy range, is sufficient
basis to sustain the penalties that CMS determined to impose. Petitioner argues also that
imposing civil money penalties of $3,550 per day against it for a 40 day period would
have a severe financial impact on it. Petitioner has offered no evidence to substantiate
this claim.

Petitioner also asserts that the immediate jeopardy level penalties are unreasonable
because, at an informal dispute resolution proceeding, the penalties were cut to one-half
of that which were originally determined to be imposed. That may be so, but it is no
basis for me to infer that the penalties of $3,550 per day are unreasonable.

Finally, Petitioner contends that CMS uses an “arbitrary, capricious, and unreasonable
double standard” in calculating civil money penalties. Petitioner’s Post-Hearing Brief at
14-16. Petitioner argues, essentially, that the penalties imposed against it are
disproportionately high when compared with penalties imposed against other, similarly
situated, facilities.

Nothing in the regulations governing civil money penalties suggests that a comparative
standard may or ought to be used in deciding civil money penalty amounts. Each case is
to be judged on its own merits, and my decision is made de novo, without regard to what
CMS may have determined to do in other cases. I have explained already why the civil
money penalty amount at issue here is reasonable based on the merits of this case, and it
is unnecessary for me to readdress those factors.

Moreover, Petitioner’s argument that the immediate jeopardy level penalties are
unreasonably high is premised, in large measure, on the fact that in some other cases the
total amount of civil money penalties (daily amount multiplied by the days of
noncompliance) was arguably lower than the total amount of penalties that are at issue
here. But, I may not reduce a daily penalty amount in consideration of the number of
days of a facility’s noncompliance. The regulations simply do not permit such
adjustments.
b. Civil money penalties of $100 per day for each day of the
December 14, 2010 — January 6, 2011 period, are reasonable.

Civil money penalties for non-immediate jeopardy level deficiencies must fall within a
range of from $50 to $3,000 per day. 42 C.F.R. § 488.438(a)(1)(ii). A decision of where
within that range a penalty amount should fall is based on the same regulatory criteria as
are used for deciding daily penalty amounts of immediate jeopardy level civil money
penalties.

The penalties of $100 per day that CMS imposed for each day of the December 14, 2010
— January 6, 2011 period are minimal, coming close to the bottom of the non-immediate
jeopardy range and consisting of only three percent of the maximum allowable daily
amount for non-immediate jeopardy level penalties. Petitioner has not offered evidence
or argument to challenge these penalties, and I find them to be reasonable.

/s/
Steven T. Kessel
Administrative Law Judge