|
Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
|
| IN THE CASE OF | |
|
Good Samaritan Center, |
DATE: March 21, 2002 |
|
- v - |
|
|
Centers for Medicare & Medicaid Services
|
Docket No.C-99-166
Decision No. CR884 |
| DECISION | |
|
DECISION I sustain the determination
of the Centers for Medicare & Medicaid Services (CMS)
(1) to impose a Civil Money Penalty (CMP) against Petitioner,
Good Samaritan Center, for failure to comply substantially with federal
requirements governing participation of long-term care facilities in Medicare
and State Medicaid programs. The CMP of $3,050.00 per day, from September
13, 1998 through September 19, 1998, is based on a finding of immediate
jeopardy. I. Background This case came before me pursuant to a request for hearing
filed by Petitioner, Good Samaritan Center, on November 25, 1998, in accordance
with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R.
�� 488.408(g), 498.40. On October 1, 1998, CMS informed Petitioner that, based
on a survey conducted on September 14 - 21, 1998, CMS was imposing selected
remedies against Petitioner due to its failure to be in substantial compliance
with the applicable federal requirements for nursing home participants.
CMS stated that it concurred with the State recommendation and was imposing
the following remedies:
The parties have agreed that there are no material issues
of fact in controversy and that this case may be disposed of by way of
summary judgment without the need for an in- person hearing. CMS proposed
12 exhibits (CMS Exs. 1A - 12A). These have
been admitted into the record without objection. Petitioner proffered
16 sixteen documentary exhibits (P. Exs. 1A - 16P). These exhibits were
admitted into the record without objection. Petitioner also proferred
a videotape exhibit, which I designate as P. Video Ex. 1. This exhibit
was offered and admitted into the record without objection. A written
transcript of the videotape appears in the record as P. Ex. 1A. Each party
submitted written briefs and response briefs in support of their respective
contentions. Based on the affidavits,
the documentary and demonstrative evidence, the written arguments of the
parties, and the applicable law and regulations, I find that, from September
13, 1998 through September 19, 1998, Petitioner was not in substantial
compliance with Medicare participation requirements and that this noncompliance
was at the immediate jeopardy level. II. Applicable Law
and Regulations Petitioner is considered
a long-term care facility under the Act and regulations promulgated by
the Secretary of the U.S. Department of Health and Human Services (HHS).
The statutory and regulatory requirements for participation by a long-term
care facility are found at sections 1819 and 1919 of the Act, and at 42
C.F.R. Part 483. Sections 1819 and 1919 of
the Act invest the Secretary of HHS with authority to impose remedies
of CMPs and denial of payment for new admissions against a long-term care
facility for failure to comply substantially with participation requirements. Pursuant to the Act, the
Secretary of HHS 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. The applicable
regulations at 42 C.F.R. Part 488 provide that facilities which participate
in Medicare may be surveyed on behalf of CMS by State survey agencies
in order to ascertain whether the facilities are complying with participation
requirements. 42 C.F.R �� 488.10 - 488.28. The regulations contain special
survey conditions for long-term care facilities. 42 C.F.R. �� 488.300
- 488.335. Under Part 488, a State or CMS may impose a CMP against a long-term
care facility where a State Survey Agency ascertains that the facility
is not complying substantially with participation requirements. 42 C.F.R.
�� 488.406, 488.408, and 488.430. The penalty may start accruing as early
as the date that the facility was first out of compliance until the date
substantial compliance is achieved or the provider agreement is terminated. The regulations specify
that a civil money penalty that is imposed against a facility will fall
into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438.
The upper range of civil money penalties, of from $3,050 per day to $10,000
per day, is reserved for deficiencies that constitute immediate jeopardy
to a facility's residents, and, in some circumstances, for repeated deficiencies.
42 C.F.R. � 488.438(a)(1) and (d)(2). The lower range of civil money penalties,
of from $50 per day to $3,000 per day, is reserved for deficiencies that
do not constitute immediate jeopardy, but either cause actual harm to
residents, or cause no actual harm, but have the potential for causing
more than minimal harm. 42 C.F.R. � 488.438(a)(2). The regulations define the
term "substantial compliance" to mean:
42 C.F.R. � 488.301. "Immediate jeopardy" is
defined to mean:
Id. In determining the amount
of the CMP, the following factors specified at 42 C.F.R. � 488.438(f)
must be considered:
In a CMP case, CMS must
make a prima facie case that the facility has failed to comply substantially
with participation requirements. To prevail, a long-term care facility
must overcome CMS's showing by a preponderance of the evidence. Hillman
Rehabilitation Center, DAB No. 1611 (1997). The Act and regulations
make a hearing available before an administrative law judge to a long-term
facility against whom CMS has determined to impose a CMP. Act, section
1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(12) and (13). The hearing
before an administrative law judge is a de novo proceeding. Anesthesiologists
Affiliated, et al, DAB CR65 (1990), aff'd 941 F2d. 678 (8th
Cir. 1991). III. Issues, findings of fact and conclusions of law
1. Whether the facility
was complying substantially with federal participation requirements on
the dates CMS determined to impose a CMP. 2. Whether CMS's determination
of immediate jeopardy is clearly erroneous. 3. Whether the amount of the penalty imposed by CMS is reasonable, if non-compliance is established.
I make findings of fact
and conclusions of law (Findings) to support my decision in this case.
I set forth each Finding below in italics as a separately numbered heading
followed by a discussion of these Findings.
The survey report listed an alleged deficiency at Tag 323 at the immediate jeopardy level, citing 42 C.F.R. � 483.25(h)(1). CMS Ex. 1A. That regulation, entitled "Quality of care," provides --
42 C.F.R. � 483.25(h)(1). The survey report stated
the findings as follows--
CMS Ex. 1A. A facility must ensure that the resident environment remains as free of accidents as is possible. 42 C.F.R. � 483.25(h)(1). Gaps between side rails and mattresses pose a real risk of harm, injury, or even death to residents in nursing homes. These risks are unequivocally real, and not merely imagined. In Wellington Specialty Care & Rehabilitation Center, DAB CR548 (1998), it was stated that--
Id. at 9. In the same decision, the
ALJ went on to say that--
Id. at 9. See also CMS Ex.
11A. Petitioner claims that it
purchased the beds from one manufacturer and the mattresses from a different
manufacturer. P. Renewed Motion at 2. When these two were used together
there was a 4.5 inch gap between the mattress and the side rail. Although
a 4.5 inch gap might not be large enough for an average person to fit
through, the yield of the mattress will allow a resident to slide more
easily between the mattress and side rail. In this particular case, the
situation was aggravated because of the soft, compressible nature of the
mattress being used by the facility. (4)
That is not to say that it was wrong to employ a soft, compressible mattress,
but that precautions should have been taken by the facility to reduce
the gap created by the bed and mattress configuration with the added gravamen
of the compressibility of the mattress. Petitioner argues that the
excerpt from the American Journal of Public Health submitted as P. Ex.
6F, contradicts the conclusions arrived at by CMS. Petitioner relies on
that portion of the journal that states, "Insufficient information was
available to evaluate the potential role in side-rail entrapment of decreased
motor control, cloth restraints, medication use, type of side rail and
poor mattress fit." Petitioner overlooks, however,
more significant aspects of that journal report. For example, it was noted
that the majority of side rail entrapment victims were 65 years or older,
and over half were 85 years or older. Females outnumbered males. Thus,
it was concluded that despite the limitations in the statistical factors
weighed, adverse events reports can suggest a profile of patients at risk
for side rail entrapment. These potential risk factors include advanced
age, female sex, low body weight, and cognitive impairment. Given this
risk profile, it is not surprising that the majority of entrapments occur
in nursing homes. P. Ex. 6F at 2. A final note of advice in the report
cited by Petitioner suggests that the number of adverse events due to
side-rail entrapment can be decreased if user facilities take the following
precautions:
Petitioner has not come
forward with documented evidence to show that they implemented any of
the suggested precautionary measures. Resident 1 is described
as a 90 year-old female with a history of seizures and coronary artery
disease, who was weak from a recent hospitalization. Her assessment revealed
that she was at risk for falls, and could not ambulate without assistance.
Additionally, the clinical record showed that her bed rails were to be
left in the down position, yet the one- fourth rails were left in the
up position at the head of the bed, at the resident's request, so that
she could position herself. CMS Ex. 6A at 15; P. Ex. 2B at 3. According
to the literature submitted by Petitioner, Resident 1 fit the profile
of those most at risk for entrapment. Nonetheless, the record is silent
as to interventions deployed to create a safe environment for this very
vulnerable elderly and frail resident. Inasmuch as Resident 1 wanted the
rails in the up position, the facility could have used protective barriers,
as suggested by the article it submitted from the American Journal of
Public Health. Because the facility failed
to eliminate the gap between the side-rail and the mattress, Resident
1 was able to slide through the existing gap and became entrapped. Petitioner
has provided forensic evidence that reveals that she died from pulmonary
embolism, not from asphyxiation. P. Ex. 2B. The Coroner's report, however,
does not attempt to explain how the entrapment may have contributed to
the resident's death. She was found with bruises on her back and neck,
and with a fractured rib, yet the Coroner did not address those findings
to a meaningful degree in his report. Petitioner, of course, places much
stock in the conclusion that Resident 1's death was due to embolism, and
not asphyxiation. However, that finding does not lay the matter of the
facility's deficient practice to rest. It is not essential to CMS's case
that a causal relationship be established between the resident's death
and the entrapment. It suffices to show that the deficiency poses a risk
that rises to the level of a likelihood that serious injury, harm, impairment
or death may occur. Fairfax Nursing Home, Inc., DAB No. 1794 (2001), at
13. Consequently, although the facts of this case reveal that the cause
of the resident's death was other than the entrapment, there is sufficient
evidence to show that the facility failed to develop and implement an
effective system to assure that the environment remained as free of hazards
as possible to prevent accidents. This failure constituted an immediate
jeopardy to the health and well being of Resident 1, in particular, and
other residents in the facility, in general. Specifically, on September
13, 1998, at 2:00 a.m., Tonya Fenwick, a nursing assistant, called Todd
Franklin, LPN supervisor, for help, because she had found that Resident
1 "was choking." Deposition of Todd Franklin, P. Ex. 1A at 1, 2. Mr. Franklin
stated in his deposition that the resident fell to the window side of
her bed and not the door side. Thus, Ms. Fenwick saw the back of the resident's
head at an angle that gave the appearance that she was choking. P. Ex.
1A at 4. From this, Petitioner concludes that the basis for the deficiency
is this mistaken impression by the nursing assistant. P. Renewed Motion
at 3. However, the information to the effect that Resident 1 was found
with her head between the mattress and side-rails was provided by facility
staff. Both LPN Christine Kennedy and LPN Supervisor Todd Franklin, furnished
reports contemporaneous with the incident reflecting that the resident's
neck was resting between the mattress and side-rails. CMS Exs. 2A, 3A
at 1. This same account of the incident was also documented by the facility
on September 13, 1998. CMS Ex. 4A at 1. Subsequently, in his deposition
of June 25, 1999, Mr. Franklin, testified that Resident 1 had a bruise
on her back as well as a bruise on her neck, which he described as a "small
indentation." Since the lesion on the resident's back was, in his opinion,
a blunt bruise, and not a scrape, he concluded that she must have been
standing, and fell backwards against the bed. I am not persuaded by such
creative reconstruction of the events. Mr. Franklin's theory does not
explain how the resident could fall backwards and wind up with her head
between the mattress and side-rail. Obviously, the resident's head could
not go through the rail, nor was there evidence of trauma to the back
of her head. Additionally, if the trauma to her back was in fact caused
by falling backwards against the side-rail, Mr. Franklin's theory does
not explain why there is no evidence of a scrape after Resident 1 hit
her back with the rail, rubbing against it on the way down to the floor.
Moreover, this theory would have me believe that the resident ricocheted
off the floor and, on the way up again, managed to fit her head between
the mattress and side-rail. Furthermore, I do not recognize Mr. Franklin
as an expert in reconstruction of traumatic injuries so as to be convinced
that the injury to the resident's back could not have occurred as a result
of falling through the gap between her bed and side-rail. Petitioner also relied on
the depositions of lead surveyor Daniel Dabney and LPN supervisor, Todd
Franklin, in support of its argument that even if a resident were caught
between the mattress and side-rail, entrapment would be unlikely. P. Renewed
Motion at 6. In this regard, Petitioner refers to Mr. Dabney's testimony
in which he stated that he, along with other surveyors and facility staff
ran a demonstration in order to test the entrapment potential of the side-rails
in question. Mr. Dabney specifically stated that his neck was the largest
in the group, and that he easily slid under the rail by scooting down.
P. Ex. 3C at 24, 28, 29, and 30. Mr. Franklin also demonstrated how he
could easily slide through the space between the mattress and side-rail.
He noted that, "[i]t's impossible to do, to get trapped. I mean, if you
slide you are not going to get trapped because you slide right through."
P. Ex. 1A at 8. Those demonstrations have
no probative value in my reaching a conclusion as to the risks posed by
the side-rail gaps in Petitioner's facility. For example, Mr. Dabney stated
that he did not get caught in the side-rail because he scooted down, that
is, he slid down swiftly to avoid entrapment. P. Ex. 3C at 24. Likewise,
Mr. Franklin avoided entrapment by his conscious effort to "slide through."
The ability of vigorous, able bodied, healthy individuals to avoid entrapment
is not to compare with the ability of frail, elderly individuals, whose
health is, physically and mentally, severely compromised. I cannot conceive
Resident 1 making a deliberate scooting effort or sliding maneuver to
avoid entrapment. Moreover, the demonstrations reinforced the finding
that a significant gap existed between the bed and side-rails in Petitioner's
facility. That gap posed a risk, likely to cause serious injury, harm,
impairment, or death to a resident. On September 14, 1998, the
day following the incident involving Resident 1, the surveyors made the
facility aware of the risks associated with potential entrapment in the
gaps between the mattress and side-rails. Nonetheless, the facility took
no steps to reduce the gap in order to protect other residents. CMS Ex.
6A at 4. As a result of the facility's failure to implement appropriate
interventions, Resident 2 became entrapped on September 18, 1998. The
interdisciplinary progress notes reveal that at 9:30 p.m. on September
18, 1998, Resident 2 called for help when he became caught between his
mattress and the side-rail. When asked by the nurse who went to his rescue
whether he could breath, he responded, "yes, for now." CMS Ex. 5A. Resident
2 continued to hold his head up with his hands while the nurse went for
more help to move him from his entrapped position. Id. When the nurse
returned she again asked Resident 2 whether he could still breath, and
he responded, "yes, but I can't hold myself up much longer." Id. With
the help of another staff member, the first nurse was able to free the
resident. Id. Afterwards Resident 2 complained of shoulder pain. Id. Petitioner argues that emphasis
should be laid, not on what the progress notes say, but, rather, on what
they do not say. In response to its own rhetoric, Petitioner fills the
blanks with a host of assertions that fail to address the fact that Resident
2 fell from his bed, and became entrapped in the side-rail. P. Renewed
Motion at 8. He was incapable of scooting or sliding
his body so as to avoid entrapment. Consequently, he was caught with his
head between the bed and side-rail. He was trapped because he could not
extricate himself, and had to call for help. He held his head up with
his hands to avoid airway compromise. When asked for a second time whether
he could still breathe, he answered that he could, for the time being,
but could not hold on much longer. CMS Ex. 5A. The message was clear;
if his arms were to give out and he could no longer hold his head up,
the rail would impede his breathing. I could infer no other conclusion.
It is simple. The resident fell from his bed and was caught between the
bed and side-rail. He could not free himself, so he cried for help. He
held his head up with his hands in order to be able to breathe. His responses
denote desperation, because he could hold on without compromising his
ability to breathe for a limited time only. The jeopardy to his health
and well-being at that moment was real and imminent, and is not to be
taken lightly or ignored. Petitioner contends that the resident used his
hands to hold himself up for fear of falling, and that his chin was not
touching the rail. P. Renewed Motion at 8. That interpretation does not
do justice to the dialogue between the nurse and the resident found in
the progress notes. His message was unequivocal; he was able to breathe
as long as he could continue to hold himself up. It is also obvious that
his chin was not touching the rail because he was holding himself up. I find that Petitioner's
noncompliance was likely to cause, serious injury, harm, impairment, or
death to Resident 2.
In view of the foregoing
discussion, it is my finding that CMS has established a prima facie case
that Petitioner was not in substantial compliance with federal requirements
for nursing homes participating in the Medicare and Medicaid programs.
Petitioner, on the other hand, has not overcome CMS's showing by a preponderance
of the evidence. Furthermore, I sustain CMS's finding that Petitioner's
level of non-compliance constitutes immediate jeopardy. Petitioner's contentions
that Resident 1's death is attributable to a cause, other than side-rail
entrapment, and that Resident 2 was never unable to breathe, are unavailing.
It is well settled that a finding of immediate jeopardy does not require
"a finding of present harm, but also encompasses a situation that is [likely
to cause] harm." Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002). Thus, it was not unreasonable
for CMS to conclude that in a facility of 84 beds of similar construction
to the ones that caused the entrapment of Residents 1 and 2, that others,
in addition to those two, were likely to suffer serious injury, harm,
impairment, or death. Resident 1 suffered a bruise
to the neck, which Mr. Franklin euphemistically described as a mere "indentation,"
such as one may experience when resting a hand or arm on the surface of
a desk, even without exerting pressure. P. Ex. 1A at 4, 5. However, others
described the mark as being a bruise on the center of the neck, that is,
closer to the throat, than Mr. Franklin would have us believe. CMS Ex.
2A; CMS Ex. 3A at 1. I infer that the indentation, with bruising to Resident
1's neck, was caused by the side-rail. It was not the slight, innocuous
indentation described by Mr. Franklin. Moreover, from the time of the
Resident's fall until she was found by the facility staff, the mark on
her neck did not disappear. Thus, CMS was justified in finding that Petitioner's
bed and side-rail configuration was very hazardous in-so-far as it was
likely that residents could fall through the gap and suffer serious harm,
including death. The 4.5 inch gap grew to 6 or 7 inches because of the
mattress's compressibility. That gap was large enough for a resident to
fall into, and small enough for residents to become entrapped. This safety
hazard placed Petitioner's residents in immediate danger. Such danger,
however, is not limited to asphyxiation, but could also result in fractures
or other injuries. CMS Ex. 6A at 3, 4. Not only was Petitioner
aware of the side-rail gaps and the risk they posed for its residents
before the entrapment incident of September 13, 1998, but it did nothing
to correct the dangerous situation until after a second resident was trapped
on September 18, 1998. Ms. Donna Demaree, Regional
Program Manager for the Kentucky Cabinet for Health Services (CHS), stated
in her affidavit that when the complaint survey began on September 14,
1998, the facility's staff was advised that Kentucky CHS was investigating
whether Resident 1 either asphyxiated or "could have asphyxiated" after
getting her neck caught between the mattress and side-rail. Additionally,
as early as September 14, 1998, the surveyors and facility staff conducted
demonstrations that showed it was physically possible for residents to
get their neck into the gaps between the bed and side-rail. CMS Ex. 6A
at 4. Petitioner has attempted
to play down the enormity of the danger to which it exposed its residents,
but has failed to come forward with persuasive evidence or reasons to
show that CMS's finding of immediate jeopardy is clearly erroneous. I, therefore, conclude that
Petitioner's residents were in immediate jeopardy from September 13, 1998
until September 19, 1998, when the facility's administrator, Bob Johnson,
ordered that all quarter length side rails be placed in the down position.
CMS Ex 6A at 8.
CMS imposed a $3,050.00
per day CMP for the period beginning September 13, 1998, and ending September
19, 1998. There is no issue as to the reasonableness of the daily amount
of the penalty, inasmuch as $3,050.00 is the minimum that may be imposed
by CMS where it is established that the participating facility has incurred
a deficiency that reaches the level of immediate jeopardy. 42 C.F.R. �
488.438(a)(i). IV. Conclusion
I conclude that CMS correctly determined that, beginning September 13, 1998 through September 19, 1998, Petitioner was not complying with federal participation requirements in the Medicare program at the immediate jeopardy level, and the imposition of a CMP of $3,050.00 per day is reasonable. |
|
| JUDGE | |
|
José A. Anglada Administrative Law Judge |
|
| FOOTNOTES | |
|
. The Health Care Financing Administration has been renamed the Centers for Medicare & Medicaid Services (CMS). Reference to either name shall apply to both names. 2. Petitioner returned to substantial compliance on September 20, 1998. Therefore, the termination was not effectuated. 3. See also Beverly Health & Rehabilitation-Springhill, DAB CR553 (1998). 4. The mattress employed by the facility allowed for a gap of approximately 6 to 7 inches. P. Ex. 1A at 5. |
|