Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Price Hill Nursing Home, |
DATE: February 23, 2001 |
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Health Care Financing Administration
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Docket No.C-98-171
Decision No. CR745 |
DECISION | |
I decide that, during the time covered by the October
1997 survey, Petitioner, Price Hill Nursing Home (the provider), failed
to be in substantial compliance with every Medicare participation requirement
for which it was cited by the Health Care Financing Administration (HCFA).
Accordingly, HCFA had the authority to impose a civil money penalty (CMP).
I decide further that, on September 3, 1997, for one day only, the provider
was not in substantial compliance with the only requirement alleged to
be deficient at an immediate jeopardy level, Tag F-324, a quality of care
requirement concerning accidents pursuant to 42 C.F.R. � 483.25(h)(2).
HCFA's determination that the provider's noncompliance on September 3,
1997 was at an immediate jeopardy level was not clearly erroneous. Because
of the immediate jeopardy finding, I conclude that $6,950 is a reasonable
CMP, comprised of $3,050 for September 3, 1997, plus $50 per day for 78
additional days of noncompliance (September 4, 1997 through November 20,
1997). I. Background The provider is a skilled nursing facility located in
Cincinnati, Ohio. The Ohio Department of Health
(State survey agency)(1) conducted a survey
of the provider from September 23 - 26, 1997, and on October 3, 1997.
Those two surveys are referred to as the October 1997 survey. Based on
the October 1997 survey, HCFA found that the provider was not in substantial
compliance with Medicare participation requirements. HCFA Ex. 34. HCFA imposed a $66,950 CMP, comprised of $3,050 per day
for 21 days of immediate jeopardy (September 3, 1997 through September
23, 1997), plus $50 per day thereafter for 58 days of noncompliance (September
24, 1997 through November 20, 1997). HCFA found the provider to be in
substantial compliance with Medicare participation requirements beginning
November 21, 1997. HCFA Ex. 36. The provider timely requested a hearing, which was held
in Cincinnati, Ohio, from April 19 - 22, 1999. During the hearing, each
party called witnesses to testify. The transcript of the hearing is referred
to as Tr. HCFA Exhibits (HCFA Exs.) 1- 39 were admitted into evidence,
but HCFA Ex. 33 was withdrawn. Post-hearing, HCFA Exhibit 40 was admitted
into evidence. Petitioner Exhibits (P. Exs.) 1- 13 were admitted into
evidence. The parties' opening briefs, referred to as P. Br. and HCFA
Br., were filed in July 1999. The parties' reply briefs, referred to as
P. R. Br. and HCFA R. Br., were filed in August 1999. II. Applicable law Skilled nursing facilities, such as the provider, participate
in the Medicare program by entering into provider agreements with the
United States Department of Health and Human Services (DHHS). Requirements
of participation are imposed by statute and regulation. Social Security
Act (Act), section 1819 [42 U.S.C. � 1395i-3]; 42 C.F.R. Parts 483, 488,
and 489. The regulations define "substantial compliance" as follows:
"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. The regulations define "immediate jeopardy" as follows:
"Immediate jeopardy means a situation in which the provider's
noncompliance with one or more requirements of participation has caused,
or is likely to cause, serious injury, harm, impairment, or death to a
resident." Id. The regulations specify that a CMP that is imposed against
a provider will fall into one of two broad ranges of penalties. Per-day
CMPs in the lower range, from $50 per day to $3,000 per day, are imposed
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. Per-day CMPs in the upper
range, from $3,050 per day to $10,000 per day, are imposed for deficiencies
that constitute immediate jeopardy to one or more of a provider's residents.
42 C.F.R. �� 488.408, 488.438(a). The preponderance of the evidence standard is applied
to resolve disputed issues of fact, except as provided by 42 C.F.R. �
498.60(c)(2), which states that, in CMP cases, HCFA's determination as
to the level of noncompliance of a skilled nursing facility must be upheld
unless it is clearly erroneous. HCFA bears the burden of coming forward with evidence
sufficient to establish a prima facie case that the provider was not in
substantial compliance with the participation requirements at issue. Once
HCFA has established a prima facie case, the provider has the ultimate
burden of persuasion: to prevail, the provider must prove by a preponderance
of the evidence that it was in substantial compliance with each participation
requirement at issue. [See Hillman Rehabilitation Center, DAB No.
1611 (1997), aff'd, Hillman Rehabilitation Center v. United
States, Department of Health and Human Services, Health Care Financing
Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13,
1999).] III. Issues The principal issue is whether the provider was in substantial
compliance with Medicare participation requirements during the time covered
by the October 1997 survey. A more specific issue is whether the provider
was in substantial compliance with 42 C.F.R. � 483.25(h)(2),
a quality of care requirement concerning accidents [Tag F-324]. If not,
a further issue is whether
the non-compliance under Tag F-324 resulted in immediate jeopardy, and
if so, when the immediate jeopardy abated. IV. Findings of fact and conclusions of law Each finding of fact and conclusion of law (FFCL) identified here pertains to the time covered by the October 1997 survey. I discuss in detail only FFCLs 1 through 6 in the Discussion section, section V.
6. HCFA's determination that the
provider's noncompliance was at an immediate jeopardy level from September
4, 1997 through September 23, 1997, was clearly erroneous. 8. Quality of care: Activities of Daily Living. The provider proved that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. � 483.25(a)(2) [Tag F-311].
10. Resident rights: Privacy. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. � 483.10(d)(3) [Tag F-164]. 11. Physical Environment: Pest Control. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. � 483.70(h)(4) [Tag F-469]. 12. Physical Environment: Resident rooms. HCFA acknowledged that it would not be proceeding regarding 42 C.F.R. � 483.70(d)(1)(ii) [Tag F-458], which had been waived. Tr. 42. 13. Quality of life: Dignity. HCFA withdrew its allegations that the provider was not in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. � 483.15(a) [Tag F-241]. Tr. 12. 14. Quality of Life: Environment. HCFA failed to establish a prima facie case that the provider was out of substantial compliance with the Medicare participation requirements specified in 42 C.F.R. � 483.15(h)(2) [Tag F-253]. 15. Resident Assessment: Comprehensive care plans. HCFA failed to establish a prima facie case that the provider was out of compliance with the Medicare participation requirements specified in 42 C.F.R. � 483.20(d) [Tag F-279]. Tr. 474-475. 16. Life Safety Code. The provider did not prove that it was in substantial compliance with four life safety code requirements [Tag K-21, K-46, K-66, and K-68]. 17. HCFA had the authority to impose a CMP. 18. A CMP in the amount of $6,950 is reasonable. V. Discussion
Following the October 1997 survey, HCFA cited the provider
with numerous deficiencies ("F-Tags"), one of which, Tag F-324, was cited
at the immediate jeopardy level ("J" scope and severity). HCFA Ex. 3 at
12. The Statement of Deficiencies from the October 1997 survey, HCFA form
2567L, can be found as HCFA Exs. 2 and 3 (revised), and P. Ex. 1. Surveyor Patricia Buczkowski, the team coordinator (leader),
testified that the survey team members became concerned about the provider's
supervision of five residents who had "WanderGuard" bracelets. The team
questioned whether the provider was properly using and monitoring the
audible movement alarm system to prevent the residents from eloping from
the facility or exiting the facility without a staff member or supervision.
Tr. 43 - 45. Of particular concern to the surveyors was whether the audible
alarm bracelets were being tested. The surveyors articulated the theory
that the provider had no system in place to monitor each resident's audible
alarm bracelet to be sure that it was functional and the batteries were
operational. HCFA Ex. 3 at 14 - 15. Ms. Buczkowski testified that the
surveyors were trying to "tell if the facility was aware if the alarm
was working or not." Tr. 93. Mr. Wolfe testified that the surveyors thought that the
bracelet system failed and that the system was not checked to see that
everything was operational until September 26, 1997. Tr. 349. Tag F-324 is a quality of care deficiency under 42 C.F.R. � 483.25(h)(2), which states:
42 C.F.R. � 483.25(h)(2). Initially, to support the Tag F-324 citation, the situations
of two residents, Resident 49 and Resident 52, were identified on the
Statement of Deficiencies. HCFA Ex. 3 at 12 -17. The situation that was
of most concern to the surveyors was that of Resident 52, who died following
surgery after a fall from the front steps. Tr. 580 - 581, 588. The situation
of Resident 52, however, was deleted from consideration by informal dispute
resolution. Tr. 236, 499. At the hearing, I informed the parties that my initial reaction was to find no deficiency under Tag F-324. Tr. 600. HCFA objected and I indicated that I would honor that objection. Id. In light of Woodstock Care Center, DAB No. 1726 (2000), I reverse my position. Woodstock was issued by an appellate panel of the Departmental Appeals Board. The within case is distinguishable from Woodstock. Nevertheless, in reliance on Woodstock, I do find a deficiency under Tag F-324. HCFA urges me not to consider how difficult Resident 49 was to manage. HCFA states:
HCFA Br. at 6 - 7. I agree with HCFA that "Resident 49's difficult behavior
does not vitiate the Facility's responsibility to adequately supervise
him." While 42 C.F.R. � 483.25(h)(2) does not impose strict liability
upon a provider where a resident wanders unsupervised, the relevant inquiry
is whether there was supervision which was adequate for the resident's
situation. Heath Nursing and Convalescent Center, DAB CR610 at
6 (1999). This would involve consideration of a variety of measures designed
to keep staff reasonably apprised of the resident's needs. The adequacy
of measures which it takes to effectuate this requirement does place a
high expectation on the provider to achieve results, but it does not amount
to strict liability or require absolute success in an obviously difficult
task. Woodstock, DAB No. 1726, at 27. See also Lakeland
Continuing Care Center, DAB CR683 (2000). HCFA determined, with regard to Resident 49, that the provider was not in compliance with the requirement to ensure adequate supervision and assistive devices to prevent accidents. Ms. Buczkowski testified that the records showed a number of instances in which Resident 49 left or attempted to leave the facility unsupervised. Tr. 46. On September 3, 1997, Resident 49 was missing from the
facility at 7:00 a.m. No alarm had sounded. One-half hour earlier, at
6:30 a.m., he had been found in the facility lobby, having gotten out
of bed, and he was redirected back to his bed. At 7:45 [a.m.], a local
hospital called the provider, indicating that Resident 49 had been picked
up on Fairbanks Avenue by ambulance, after he had been found by the police.
Tr. 46, 492. HCFA Ex. 18 at 42 - 43. He stayed at the hospital overnight
for observation. The following discharge summary was dictated by Amador
Delamerced, M.D.:
HCFA Ex. 18 at 13. Sutures were required for a laceration at the tip of Resident
49's right ear and across his nose, which was fractured. His arms and
legs were severely bruised. On September 4, 1997, Resident 49 was readmitted
to the provider's facility. His skin assessment documented in the provider's
nurses' notes showed multiple bruises and abrasions. He had bruises on
his right shoulder, both elbows, both hands and knuckles, left hip, both
knees, left side of his face, bridge of his nose, and chin. He had abrasions
on the knuckles, knees, and chin. The source of his injuries remains unknown.
Id. at 16 - 17, 42 - 44; Tr. 49 - 50. He may have fallen, as the
provider postulates. His injuries were consistent with a fall. On September 3, 1997, when the provider staff found that Resident 49 was not in the facility and the alarm had not sounded, they called the company that had installed their audible alarm system that day. The brand name of their system was not actually "WanderGuard," but Cotag (for the bracelets) and Doorgard (for the keypads, placed at exit doors). The company assessed the whole system the same day, September 3, 1997, and found a malfunctioning key pad, which they replaced, that day. Tr. 486 - 489; P. Ex. 13. The provider supplied the surveyors with the invoice showing the work done on September 3, 1997. Tr. 490, 512 - 513, 518. The keypad had not actually failed, but was "by-passing," by discontinuing the alarm as soon as the exit door closed. Thus, the alarm was sounding only momentarily. The by-pass feature was removed totally, so that the alarm would no longer be discontinued prematurely. Tr. 490.The surveyors apparently did not have the written Cotag wrist tag information. P. Ex. 13, at 1- 2; HCFA Br. at 5. The Cotag information was given to the provider when it purchased the whole system [the audible alarm system]. Tr. 582. The surveyors may also not have had the Doorgard keypad information. Tr. 414 - 415, 553 - 561; P. Ex. 13 at 3 - 8. Nevertheless, those written materials, together with the testimony of Rhonda Sims, whom I found to be very credible, persuade me that only the provider's keypad was faulty, not any of the provider's audible alarm bracelets (wrist tags). Tr. 486 - 488. Ms. Sims' testimony was corroborated by the testimony of Sondra Dee Schoemaker. Tr. 587 - 590. At the time of the hearing, Ms. Schoemaker, a licensed practical nurse, had been employed at the provider's facility for 11 years. Ms. Schoemaker testified (on surrebuttal) that the first two pages of Exhibit 13 [the Cotag pages] had been offered to the surveyors during the survey. She testified that the provider had had that information "at the beginning, when our [audible alarm] system was placed." Tr. 587 - 588. In response to direct examination, Ms. Schoemaker testified: Q Was there, in your opinion, a problem with Resident 49's wrist tag? A No. Q Why not? A Cause it was very functional, worked very well on alarming. Tr. 589. Ms. Schoemaker described the gathering in the main nursing office during the survey. The provider staff that she identified as being present were Ms. Sims, Ms. Kersey, and herself. The surveyors she identified as being present were Patty [Patricia Buczkowski] and Ms. Thompson. In response to the question, "What was the discussion about?" Ms. Schoemaker replied, "Well, I know that we were trying to argue our case against the citation under Resident 52, at the time, and Resident [49]. . . . So, we were trying to discuss and argue out our points on that case." When asked, "What was the primary discussion about?" Ms. Schoemaker replied, "52." And then, at some point there became an issue about the alarm system?" Ms. Schoemaker replied, "Yes, the issue about the monitoring, the system we had put in place for monitoring on the alarms. We did not necessarily have a documented out system that they were looking for to address that." Tr. 589 - 590.
The surveyors acknowledged the repair of the key pad, with the following entry on the Statement of Deficiencies:
HCFA Ex. 3 at 14. It is unclear to me whether the surveyors understood that
the key pad was repaired on September 3, 1997. The surveyors wrote the following in the Statement of
Deficiencies:
HCFA Ex. 3 at 15. The evidence shows that the provider acted promptly and
effectively to determine why the system failed on September 3, 1997 and
to get the system repaired that day. The provider had had the system about
15 months prior to the October 1997 survey. Tr. 537.
In July 1996, documentation regarding Resident 49's behavior
included the following Reason for Care Plan Decision:
P. Ex. 8 at 136. I find that the provider's audible alarm system was only
one of at least nine different methods and approaches the provider used
to prevent Resident 49 from leaving the facility without supervision.
Tr. 422 - 427; HCFA Ex. 18 at 60 - 64. The provider and the treating psychiatrists
worked to minimize Resident 49's anxiety and agitation while avoiding
lethargy. There were frequent psychiatric consults in an attempt to balance
his medications. Restraints were contraindicated and none were applied.
The provider sought to improve any conditions, such as his impaired cognitive
status, his unsteady gait, and his urinary tract infection, which could
interfere with Resident 49 attaining his highest practicable physical,
mental, and psychosocial well-being. The interventions for such problems
would be expected also to help keep him from trying to leave the facility.
The provider staff frequently checked Resident 49. The provider's care
plan for Resident 49 could be described as holistic and compassionate
and effective. It is obvious that the provider and Resident 49's psychiatrists
had the objective of keeping Resident 49 as fully functioning as possible
while keeping him safe. In mid-September 1997, Resident 49 was found to have a "sub therapeutic valproic acid level," demonstrating the difficulty in balancing his medications. P. Ex. 8 at 9. Following the October 1997 survey, the provider staff attempted to find placement for Resident 49 in a locked facility, as shown by documentation dated October 28, 1997 and November 3, 1997. Resident 49's sister was contacted relative to a possible "lock unit." Two nursing facilities in the area assessed the resident, but were unable to take him due to being unable to provide more monitoring than he was receiving at the provider's facility. The licensed social worker also tried to find alternative placement for Resident 49, but was unable to locate placement that would provide better security monitoring than the provider's current system. HCFA Ex. 18 at 82 - 83; Tr. 455 - 456. In about March 1998, Resident 49 broke out a bathroom
window to climb out of the provider's facility. Based on that behavior,
treating psychiatrist Dr. Massoud determined to place Resident 49 in a
lock unit in a Veterans facility and discharge him from the provider's
facility. Tr. 532 - 534, 589 - 590. The relevance of that information
is that it confirms how very difficult it was to provide care and services
to Resident 49.
I find that it was not likely,
and there was not a high probability,
that any resident would suffer serious injury, harm, impairment, or death,
from the provider's failure until September 23, 1997 (actually, until
September 26, 1997) to have a system for testing in place. There is no
evidence to prove that any of the provider's five residents who wore the
wrist bracelets remained at risk for serious injury, once the key pad
was repaired. There is no evidence that any bracelet ever malfunctioned
or was likely to malfunction. The surveyors articulated that each wrist bracelet was
required to be tested periodically, relying on the WanderGuard manufacturer's
guidance. In response to the survey and the Statement of Deficiencies,
the provider started testing each resident's wrist bracelet periodically
and had in-service training, which is excellent preventive maintenance,
even though the facility was not using a WanderGuard product. The surveyors' conclusion that the five residents were
at risk of serious harm until such preventive precautions were in place
is clearly erroneous because it is not likely, and there was not a high
probability, that the bracelets, which were operating fine, were going
to stop functioning during the period beginning September 4, 1997 and
ending September 26, 1997 and contribute to the serious injury, harm,
impairment, or death of one of the residents. I am persuaded that, before I could find that the provider remained deficient in ensuring that each resident received adequate supervision and assistive devices to prevent accidents, I should be able to articulate what act or omission on the part of the provider caused it to fall short of meeting that requirement. I find the provider deficient for failure to keep Resident 49 from exiting the facility unwitnessed on September 3, 1997, between 6:30 a.m. and 7:00 a.m. The deficiency ended, in my view, when Resident 49 was located and adequately cared for, and the audible alarm system was functioning properly. That was also September 3, 1997. VI. ConclusionThe provider was not in substantial compliance with all Medicare participation requirements during the time covered by the October 1997 survey. HCFA had the authority to impose a CMP. There was immediate jeopardy for one day, September 3, 1997. A $6,950 CMP is reasonable. |
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JUDGE | |
Jill S. Clifton Administrative Law Judge
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FOOTNOTES | |
1. HCFA contracts with state health agencies to conduct surveys of skilled nursing facilities' compliance with Medicare participation requirements. Sections 1864 and 1819(a) of the Social Security Act; 42 U.S.C. � 1395aa; 42 U.S.C. �1395i-3(g); and 42 C.F.R. � 488.20. | |