Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Barn Hill Care Center, |
DATE: May 10, 2002 |
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Centers for Medicare & Medicaid
Services
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Docket No.C-00-107
Decision No. CR902 |
DECISION | |
DECISION Barn Hill Care
Center (Petitioner or Facility) is a nursing facility, located in New
Jersey, that is certified to participate in the Medicare and Medicaid
programs as a provider of services. Petitioner challenges the Centers
for Medicare and Medicaid Services' (CMS) determinations that, from August
2, 1999 through August 11, 1999, it was not in substantial compliance
with Medicare requirements, and that its deficiencies posed immediate
jeopardy to resident health and safety. For the reasons set forth below,
I conclude that from August 2, 1999 through August 11, 1999, the facility
was out of compliance with the program participation requirements for
Staff Treatment of Residents, Resident Assessment, Quality of Care, and
Administration. The facility's deficiencies posed immediate jeopardy to
resident health and safety, and the amount of the civil money penalty
imposed - $5,000 per day for 10 days ($50,000 total) - is reasonable. I.
Background On July 28,
1999, Petitioner's temporary employee, who did not have a valid New Jersey
nursing license, administered overdoses of insulin to four facility residents.
They became ill, and one was hospitalized. Stipulations 1, 2, 6, 7; see
Discussion, infra.
The facility reported the incident to the New Jersey Department of Health
and Senior Services (State Agency), which conducted a complaint investigation
survey at the facility on August 2, 1999. CMS Ex. 8. Following the survey,
the State Agency concluded that the conditions at the facility posed immediate
jeopardy to resident health and safety, citing four areas of deficiency:
Staff Treatment of Residents, 42 C.F.R. � 483.13 (Tag 224); Resident Assessment,
42 C.F.R. � 483.20 (Tag 281); Quality of Care, 42 C.F.R. � 483.25 (Tag
333); and Administration, 42 C.F.R.� 483.75 (Tag 499). CMS Exs. 3, 4,
and 5. CMS reviewed
the state findings and, by letter dated August 13, 1999, advised the facility
that its conditions constituted immediate jeopardy to resident health
and safety, and, therefore, its provider agreement would be terminated
on August 25, 1999, if the immediate jeopardy were not removed. CMS also
imposed a denial of payment for new admissions, effective August 21, 1999,
and a Civil Money Penalty (CMP) of $5,000 per day, effective August 2,
1999, to remain in effect until the facility achieved substantial compliance
with program requirements or was terminated. CMS Ex. 2. The facility
submitted a plan of correction, dated August 6, 1999, and, following a
revisit survey on August 12, 1999, the State Agency concluded that the
facility had achieved substantial compliance. CMS Ex. 6. CMS reviewed
the state findings, and, by letter dated September 24, 1999, advised the
facility that because it had achieved substantial compliance, CMS was
rescinding the denial of payment for new admissions. However, CMS was
imposing the $5,000 per day CMP, from August 2, 1999 through August 11,
1999, for a total of $50,000, and the facility was prohibited from conducting
its own nurse aide training and competency evaluation for a period of
two years. CMS Ex. 1. Petitioner timely requested a hearing. A hearing was
held before me on July 24, 2001, in Trenton, New Jersey. Mr. Joseph L.
Bianculli appeared on behalf of Petitioner, and Mr. David A. Rawson appeared
on behalf of CMS. CMS Exhibits (Exs.) 1 through 15 and Petitioner's Exhibits
(P. Exs.) 1 through 44 were admitted into evidence. II.
Issues 1. Whether,
from August 2, 1999 through August 11, 1999, the facility was in substantial
compliance with program participation requirements, specifically 42 C.F.R.
� 483.13 (Staff Treatment of Residents), 42 C.F.R. � 483.20 (Resident
Assessment), 42 C.F.R � 483.25 (Quality of Care) and 42 C.F.R. � 483.75
(Administration). 2. If the facility
was not in substantial compliance, did its conditions pose immediate jeopardy
to resident health and safety? 3. If the facility
was not in substantial compliance, is the amount of the Civil Money Penalty
imposed, $5,000 per day, reasonable? III.
Statutory and regulatory background The Social
Security Act (Act) sets forth requirements for nursing facility participation
in the Medicare and Medicaid programs, and authorizes the Secretary of
Health and Human Services to promulgate regulations implementing the statutory
provisions. Act, sections 1819 and 1919. The Secretary's regulations governing
nursing facility participation in the Medicare program are found at 42
C.F.R. Part 483. To participate
in the Medicare program, a nursing facility must maintain substantial
compliance with program requirements. To be in substantial compliance,
a facility's deficiencies may pose no greater risk to resident health
and safety than "the potential for causing minimal harm." 42 C.F.R. �
488.301. A facility's noncompliance constitutes immediate jeopardy if
it has caused or is likely to cause "serious injury, harm, impairment,
or death to a resident." Id.
Immediate jeopardy can exist regardless of the scope and severity of the
deficiency, so long as the deficiency involves a potential for more than
minimal harm. Lake City Extended
Care Center, DAB No. 1658, at 17 (1998). Under the statute and the "quality of care" regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. � 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity. The assessment must be comprehensive, accurate, standardized, and reproducible. 42 C.F.R. �� 483.20, 483.25. The facility
is required to make a comprehensive assessment of a resident's needs promptly
after a significant change in the resident's physical or mental condition.
The services provided must meet professional standards of quality and
be provided by qualified persons. 42 C.F.R. � 483.20(k)(3). Also, as part
of the quality of care requirements, the facility must insure that residents
are free of any significant medication errors. 42 C.F.R. � 483.25(m)(2). Similarly,
under the "administration" requirement, the facility must be administered
in a manner that enables it to use its resources effectively and efficiently
to attain or maintain the highest practicable physical, mental, and psycho-social
well-being of each resident. 42 C.F.R. �483.75. Specifically, the facility
must employ, on a full-time, part-time, or consultant basis, those professionals
necessary to carry out the regulatory requirements. Professional staff
must be licensed, certified, or registered in accordance with applicable
State laws. 42 C.F.R. � 483.75(g). With respect
to staff treatment of residents, the facility must develop and implement
written policies and procedures that prohibit mistreatment, neglect, and
abuse of residents and misappropriation of resident property. 42 C.F.R.
� 483.13(c). If a facility
is not in substantial compliance with program requirements, CMS has the
authority to impose one or more of the enforcement remedies listed in
42 C.F.R. � 488.406, which include imposing a CMP. See
Act, section 1819(h). CMS may impose a CMP for the number of days that
the facility is not in substantial compliance with one or more program
requirements or for each instance that a facility is not in substantial
compliance. 42 C.F.R. �� 488.430(a); 488.440. In situations
where the deficiencies do not constitute immediate jeopardy, but have
caused actual harm or have the potential for causing more than minimal
harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day.
Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies
constituting immediate jeopardy. When penalties are imposed for an instance
of noncompliance, the penalties will be in the range of $1,000 to $10,000
per instance. CMS increases the per day penalty amount for any repeated
deficiencies for which a lower level penalty amount was previously imposed.
42 C.F.R. � 488.438. In setting
the amount of the CMP, CMS considers: 1) the facility's history of noncompliance;
2) the facility's financial condition; 3) the factors specified in 42
C.F.R. � 488.404; and 4) the facility's degree of culpability, which includes
neglect, indifference, or disregard for resident care, comfort, or safety.
The absence of culpability is not a mitigating factor. 42 C.F.R. � 488.438(f).
The section 488.404 factors include: 1) the scope and severity of the
deficiency; 2) the relationship of the deficiency to other deficiencies
resulting in noncompliance; and 3) the facility's prior history of noncompliance
in general and specifically with reference to the cited deficiencies. IV.
Burden of proof The facility
must prove, by a preponderance of evidence, substantial compliance with
program participation requirements, once CMS has established a prima facie
case that the facility was not in substantial compliance. Emerald
Oaks, DAB No. 1800, at 4 (2001); Cross
Creek Health Care Center, DAB No. 1665 (1998), applying Hillman
Rehabilitation Center, DAB No. 1611 (1997), aff'd,
Hillman Rehabilitation Center
v. HHS, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999). V.
Findings of fact, conclusions
of law and discussion In reviewing
CMS' determination here, I must answer two questions: 1) Was the
facility in substantial compliance with the cited regulatory provisions?
CMS must present a prima facie case with evidence that, if credible and
unrebutted, would constitute proof that the facility was not in substantial
compliance. The facility then has the ultimate burden of showing, by a
preponderance of the evidence, its substantial compliance with each cited
provision. Koester Pavilion,
DAB No. 1750 (2000). 2) If I conclude
that the facility was not in substantial compliance, I next consider whether
the level of non-compliance posed immediate jeopardy to resident health
and safety. CMS' determination as to immediate jeopardy must be upheld
unless clearly erroneous, 42 C.F.R. � 498.60(c)(2), and the level of noncompliance
is subject to review only if a successful challenge would affect the range
of the CMP amounts that CMS could impose. I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding below, in italics and bold, as a separate hearing.
The parties may quarrel about the inferences to be drawn from them, but the basic and dispositive facts in this case are not in dispute. Petitioner employed temporarily Dawn Keady as a licensed practical nurse (LPN). Stipulation 1. Nurse Keady did not have a valid New Jersey LPN license. Stipulation 2; Tr.at 38 . She worked in the facility six times without producing evidence of her license. On July 28, 1999, she was assigned to the Newtonian Unit of the facility, where four insulin-dependent diabetic individuals resided. That morning, she used the wrong type of syringes to administer insulin, and, as a result, administered overdoses of insulin to the four diabetic residents. Stipulations 3 - 6. At least three of the four experienced adverse effects. Stipulation 7. Shortly after receiving her overdose of insulin, Resident 3 (1) became acutely ill and went into respiratory distress, which Nurse Keady observed. Nurse Keady called the resident's treating physician, but Resident 3 was essentially left untreated from 9:00 AM until 11:30 AM when staff happened upon her, near death. (2)
That Nurse
Keady was unlicensed in New Jersey, and Petitioner should not have allowed
her to work as an LPN is beyond dispute. (3)
Allowing an unlicensed person to pass medications plainly violates federal
requirements. See 42 C.F.R.
�� 483.20(k)(3); 483.75(b), (g), and (h). Nor was this a one-time aberration.
From July 2 through July 28, 1999, Nurse Keady worked as an LPN at the
facility six times (Tr.at 75) without demonstrating that she was licensed.
Tr.at 41. Petitioner apparently only learned that she was not licensed
after the fact, during its investigation into the insulin overdoses. CMS
Ex. 10. Petitioner
admits the deficiency, but downplays its significance, characterizing
its error as simply "allowing someone to work without producing a license."
Citing only to its own witness' testimony, Petitioner claims "no dispute
that Keady's licensure status was immaterial to the errors she made."
P. Brief at 30. I find the opposite to be true; in fact, Nurse Keady's
licensure status is inextricably intertwined with her performance, and
the fact that she was unlicensed is cited throughout the statement of
deficiencies in discussing the deficiencies that posed immediate jeopardy
to resident health and safety. Under 42 C.F.R. � 483.13 (staff treatment
of residents), CMS states: "The insulin was provided by an LPN who is
not licensed in the State of New Jersey." Under � 483.20 (Resident Assessment),
the statement reiterates "The LPN . . . who had no license to practice,
administered Insulin . . . ." CMS Ex. 3, at 3; emphasis added. This was not
a situation in which a licensed employee simply failed to produce evidence
of licensure, but otherwise comported herself in an exemplary manner.
Nurse Keady did not produce a license because she did not have one; she
was unqualified to perform the duties assigned; and her inadequacy had
consequences, all factors that remove this deficiency from the merely
technical category. Nor is it surprising that this unlicensed nurse's
performance did not otherwise meet professional standards of quality,
since a relationship exists between licensing and competence. Licensing
protects the public from incompetent practitioners. As a matter of law,
an unlicensed nurse is not qualified to provide professional nursing services,
and may not administer medications. And this case well illustrates the
logic of that requirement. Nor am I persuaded
that Nurse Keady's New York license somehow excuses Petitioner's error
in allowing her to work. The New Jersey facility's allowing her to provide
services without requiring that she could legally do so in New Jersey
per se violates the regulations. 42 C.F.R. �� 483.20(k)(3); 483.75(g).
To hold otherwise would absolve parties from compliance with state law,
which I am not authorized to do. Besides, Petitioner has not claimed that
Nurse Keady was otherwise competent, and admits that her performance was
abysmal. As the uncontroverted
evidence shows, the absence of a valid license was only part of the problem.
Not only was Nurse Keady legally unqualified to perform LPN duties, she
was not capable of performing those duties, and the fact that she may
have held a license from another state did not make her qualified -- either
legally or otherwise -- to work as a nurse at the facility.
(4) From her first day, staff questioned whether she was up
to the job. In unchallenged testimony, Surveyor Bennett recounted her
conversation with Nurse Witt, a registered nurse who was the facility's
development and in-service coordinator. Nurse Witt was responsible for
orienting new employees, including Nurse Keady, to the facility. She told
the surveyor that Nurse Keady was new to the profession, having worked
for her agency as a home health aide until June 1, 1999, when she changed
her status to LPN. Tr. at 41. She described Nurse Keady as "overwhelmed"
by the demands of the job, complaining on her first day that the medication
pass was heavy. Tr.at 42. Even though it was her first day, and even though
she complained, no one assisted her or observed her performing the medication
pass. Tr. at 44. Nurse Keady
next returned to work at the facility on July 6. After she left that day,
staff noted blanks on the medication administration record where she failed
to sign, which suggests that the ordered medication had not been given.
When staff called the agency to inquire, Nurse Keady claimed that she
had given all medications, but simply failed to sign the record as required.
Surveyor Bennet, who is herself a registered nurse, explained that such
failure to sign presents dangers because it indicates that the medication
was not given, which could prompt someone else to administer the medication
a second time. Tr. at 44 - 45. (5) The
record is virtually silent as to Nurse Keady's performance on the three
subsequent days she worked at the facility. She was not assigned to the
Newtonian Unit on those days, but the record does not reflect the nature
of her assignment, the demands placed on her, nor the quality of her performance.
(6) Although Petitioner willingly concedes Nurse Keady's inadequacies, it admits little direct culpability in having allowed her to work. Petitioner excuses itself by placing the blame instead on the agency that supplied Nurse Keady, arguing that the facility justifiably relied on that agency to provide qualified nurses. Becky Mengel, who works for Petitioner's corporate offices as Director of Clinical Services for part of the mid-Atlantic region in Pennsylvania, testified that she expects any agency nurse to be able to perform independently. Tr. at 141, 155. The regulations, however, place responsibility for the adequacy of staff squarely on the facility and do not allow it to transfer that responsibility to an outside entity:
42 C.F. R.
� 483.75(h)(2) (emphasis added). I note that, consistent with this requirement,
Petitioner's agreement is silent as to the staffing agency's responsibility
for the adequacy of its staff, but holds the facility responsible for
orientation and supervision of personnel "while the personnel are performing
services." P. Ex. 44, at 2. Further, the agreement effectively incorporates
the provisions of the regulation. Id.
at 3. ("[A]ny provision . . . deemed to be in violation of any Federal
or State law or regulation governing the subject matter of this agreement
. . . shall be amended in accordance with said law or regulation.") Petitioner
was thus accountable for the performance of all facility staff, including
the agency nurses. Petitioner also suggests that it should not be held accountable for problems that stem from "human error," rather than from any systemic weakness in the facility's administration. Tr. at 143. Conceding that it is not appropriate for a nurse who is unlicensed in New Jersey to be passing medications in a New Jersey facility, and that the facility repeatedly allowed Nurse Keady to perform duties that can only be performed by a licensed nurse, Director Mengel nevertheless insisted that the facility processes were sufficient, placing the blame on facility staff:
Tr. at 156 - 157. I am not aware of any "human error" exception to the regulatory requirements. Indeed, it is difficult to imagine any deficiency that is not, at its core, attributable to "human error." A facility, therefore, puts in place systems that minimize the chance for human error. Here, notwithstanding Petitioner's protestations, this facility simply did not have the necessary systems in place to protect its residents from unlicensed and unqualified staff. Director Mengel claimed that she reviewed the facility policies and procedures, including the orientation for agency nurses and the license verification process, and that she found nothing inadequate. Tr. at 136. However, when asked whether the facility had submitted such documents as exhibits, she subsequently admitted that those policies or procedures were not "reduced to writing," but were "processes that were in place at the center." Tr. at 138. Petitioner's performance demonstrates that it lacked adequate safeguards to ensure that only licensed and qualified persons provided the necessary professional services, in contravention of 42 C.F.R �� 483.25 (quality of care), and 483.75 (administration). See Emerald Oaks, DAB No. 1800, at 7 n.3 (2001)(discussed supra).
That significant
medication errors occurred is undisputed. Not only were four residents
given dangerous overdoses of insulin, but for one-third of the residents
on the Newtonian Unit, medications were not timely administered according
to acceptable standards of practice. In uncontroverted
testimony, Surveyor Bennett explained that standards of practice require
that medications be administered within one hour of the time ordered.
So, the 9:00 AM medication pass could begin as early as 8:00 AM, and should
be completed by 10:00 AM. Nurse Keady, however, was not able to finish
administering the medications within a reasonable time. By 11:30 AM, she
had still not administered the ordered medications to 10 of 29 residents.
CMS Ex. 3 at 3. Indeed, according to Nurse Witt, who was eventually assigned
to help with the 9:00 AM medication pass, she and Nurse Keady did not
complete the task until 2:00 PM. CMS Ex. 15 at 4. Contrary to Petitioner's
claim that "CMS offered no evidence that any resident actually was injured
by Nurse Keady's delay," (P. Brief at 7), the record suggests that at
least one resident desperately needed her 9:00 AM medication. Resident 3
was among those who had not received their 9:00 AM medication by 11:30
AM. She suffered from congestive heart failure and was on oxygen. Her
routine 9:00 AM medications included Prednisone, Theodur, and a Nebulizer
treatment, which are intended to alleviate respiratory problems. Tr. at
50 . At 9:00 AM, Nurse Keady noted that Resident 3 was weak and had difficulty
breathing, so that she subsequently called Resident 3's attending physician
to advise him of the respiratory distress; yet, she did not administer
the medication that had been ordered to alleviate Resident 3's respiratory
symptoms. Failure to
administer medication timely was not the only significant medication error
of the morning. Insulin is routinely administered at the start of the
morning medication pass because those dependent on insulin need to have
it before breakfast. Tr. at 154. Between 7:30 AM and 8:00 AM on the morning
of July 28, 1999, Nurse Keady, apparently using the wrong type of syringes,
administered overdoses of insulin to the four insulin-dependent residents
on the Newtonian Unit who suffered significant, adverse reactions. CMS
Exs. 3, at 3, 13 at 7; P. Exs. 2, 3. Resident 1 (7)
was found unresponsive and foaming at the mouth at 12:45 PM. P. Ex. 8,
at 2. A blood sugar finger stick did not register on the glucometer because
her level was too low. P. Ex. 8 at 2. At 1:00 PM, her level was 34. IV
Dextrose was administered and at 1:45 PM her blood sugar was 83. CMS Ex.
3, at 4; P. Exs. 21, 22, 23, 24. According to a facility statement, Resident
1 also exhibited signs of low blood sugar on the 3:00 - 11:00 PM shift.
P. Exs. 2, 8, at 2. Resident 2 (8) was found slumped in her chair sometime between noon and 12:30 PM. Her blood sugar was 31. She was treated, and at 5:00 PM, her blood sugar was 38. CMS Ex. 3, at 5; P. Ex. 8, at 2; P. Ex 10; see P. Ex. 2.
Resident 3 was admitted to the hospital with profound
hypoglycemia, among other diagnoses. P. Ex. 16. Resident 4 (9) was found
unresponsive in bed at 5:00 PM, with a large skin tear on her right arm
caused by a fall against a door. Her blood sugar was 40. She was given
orange juice and sugar, and then dinner. P. Exs. 9, 34. At 7:00 PM her
blood sugar was 66. P. Ex. 34. Thus, the facility failed to administer medications according to accepted standards of practice. It did not insure that residents were free of significant medication errors. Further, residents were not provided care and services in accordance with physician's orders, assessments, and medication orders. On this basis, CMS appropriately determined that the facility did not meet regulatory requirements under 42 C.F.R. �� 483.25 (quality of care) and 483.20 (resident assessment), and that its failures constituted substantial noncompliance.
CMS also concluded
that, in contravention of 42 C.F.R. � 483.13(c), the facility had not
developed and implemented written policies and procedures that prohibited
the neglect of its residents. In addressing this issue, I consider whether
the facility actions (or inaction) constituted neglect, and, if so, whether
such neglect constitutes a deficiency under 42 C.F.R. � 483.13(c).
(10)
Neglect means
failure to provide goods and services necessary to avoid physical harm,
mental anguish, or mental illness. 42 C.F.R. � 488.301. Based on 1) the
facility's failure to administer, within acceptable time parameters, medications
to 10 residents out of 29; 2) the administration of insulin overdoses
to 4 residents; and 3) the facility's treatment of Resident 3 when she
became acutely ill on the morning of July 28, CMS concluded that the facility
had not prevented the neglect of its residents. CMS Ex. 3, at 1-3. About
the timeliness of the drug administration, and the insulin overdoses,
there is no serious factual dispute. Petitioner seems to overlook those
two bases for CMS' neglect finding, confining its argument to the treatment
provided to Resident 3 when she became acutely ill. However, the failures
and errors in the administration of medication also constitute neglect. In considering
the treatment (or lack of treatment) provided to Resident 3, I note first
that, in defending its practices, Petitioner did not call as witnesses
any staff who were working in the facility at the time, who might have
had first hand knowledge of the care provided. Throughout the record are
references to staff, in addition to Nurse Keady, who were present in the
Newtonian Unit throughout the day. See
P. Exs. 8, 9, 10, 21. However, instead of calling them, Petitioner submitted
documentation, mostly staff statements generated after the fact, that
is inconsistent, incomplete, confusing, and, in some instances, illegible.
Petitioner then goes through the staff statements and through Resident
3's sketchy medical record, drawing inferences in the light most favorable
to the facility, sometimes in very unreasonable, even fanciful, ways. The record establishes that Resident 3 was seriously ill. Among other ailments, she had a significant history of chronic obstructive pulmonary disease (COPD), congestive heart failure, and insulin dependent diabetes. P. Ex. 16. In addition to insulin, her medication orders included Lasix, Theodur, Prednisone, and a nebulizer treatment, to be administered at 9:00 AM. According to July 28 treatment notes, at 6:00 AM, staff observed "some effort needed to breathe," although the resident claimed that it was "no harder than normal." The nurse then noted that she would "continue to observe." P. Ex. 13, at 2. The record does not reflect whether this information was conveyed to Nurse Keady or to anyone else at the 7:00 AM staff change. In their statements, no staff member suggests that she had advance notice that Resident 3 had been experiencing breathing problems. At approximately 8:00 AM, Nurse Keady administered the insulin overdose. P. Ex. 8. In a statement drafted the following day, she indicates that, as early as 8:00 AM, Resident 3 was "pale, weak, weezing [sic], with R upper lobe crackles." P. Ex. 8. (11) However, the treatment notes say nothing about the resident's condition at 8:00 AM, instead stating that at 9:00 AM, Resident 3 was "weak" with "difficulty breathing." P. Ex. 13, at 2. Based on this, Petitioner infers "it seems clear that Nurse Keady did assess the Resident at least twice before 9:00 or 9:30." P. Brief at 9. I can draw no such inference. It appears to me that both notes were written after the fact -- as Petitioner admits (see P. Brief at 11 ) -- and Nurse Keady was not particularly careful in noting the specific times of any of the events of the day. In neither the treatment record nor her statement did she claim to have observed Resident 3's breathing difficulties on more than one occasion. Moreover, if Resident 3 had been assessed twice, I would have expected two sets of vital signs recorded in her treatment records. Neither the treatment records themselves, nor the statements from staff indicate that staff provided assessments or treatment between9:00 AM and 11:30 AM. The absence of any recorded observations
does not support the claim that staff were keeping the resident under
close observation. See
Emerald Oaks at 24. Sometime after 9:00 AM, Nurse Keady called Resident 3's
primary care physician, Dr. Grote, who subsequently ordered a complete
blood count (CBC), chest x-ray, and sputum culture, and an IM injection
of Rocephen, an antibiotic, to be administered after the blood culture.
Nurse Keady's July 29 statement indicates that Dr. Grote called in his
orders at 10:00 AM (P. Ex. 8), although the physician order sheet indicates
that he called in at 10:30 AM. P. Ex. 14. Based on the muddled record before me, it is difficult
to determine the timing of the events of July 28. However, this much is
plain: the record contains no reliable evidence that staff adequately
monitored Resident 3's condition, or provided her with care (not even
her routine respiratory medications) from at least the time of Nurse Keady's
observation at 8:00 or 9:00 AM until sometime after 11:30 AM, when Nurse
Witt found her unresponsive, in acute respiratory distress. Tr. at 50,
65; P. Ex. 13, at 2. Petitioner submits only a partial treatment record for
Resident 3, which consists of three pages, with some pages obviously missing.
Page one of the document includes notes from July 22 through 27, 1999,
which are of limited relevance to this case. Page two contains additional
treatment notes for July 27, and notes for July 28, including Nurse Keady's
notes, which on their face, appear to have been written at 8:00 AM, 9:00
AM, noon, and 1:00 PM, although Petitioner maintains, and I have no reason
to doubt, that Nurse Keady drafted them all at the same time, after the
fact. P. Ex. 13 at 2. A third page of treatment notes, obviously written
by someone other than Nurse Keady, follows. The page begins mid-sentence,
with the notation "Nsg. cont." This first partial entry describes Resident
3's breathing (respirations 50 shallow, labored) but does not indicate
the time of that observation, information likely contained on a page that
Petitioner did not submit. (12)
Looking to the other evidence, a statement from LPN Sandy
Osborne describes a conversation she had with Nurse Keady "after lunch
trays were delivered to Newtonian Hall," (13)
when she brought to Nurse Keady's attention the crisis with Resident 2.
"Dawn said 'I cant [sic] handle this. I have to give [Resident 3] this
Rocephen.'" P. Ex. 10. Nurse Osborne relates that she herself immediately
attended to Resident 2, which, according to Resident 2's treatment records,
occurred at noon. P. Ex. 28. Nurse Osborne subsequently called DON Callahan
to tell her that Nurse Keady needed help "because she couldn't handle
the hall between dealing with [Resident 3] and what was happening with
[Resident 2]." Id. This
suggests that, by as late as noon the Rocephen had not been administered,
and that Nurse Osborne contacted DON Callahan at about noon. After making
the call, Nurse Osborne relates that she performed Accuchecks on another
unit, and returned to check on Resident 2, and then went to report to
Nurse Keady, who asked for help in administering the Rocephen. After demonstrating
how to draw up the Rocephen, Nurse Osborne returned to her desk, but approximately
two minutes later, the aides called her to go to room 20, where she found
Resident 1 "frothing from the mouth and unresponsive." P. Ex. 10. According
to Resident 1's treatment records, this occurred at 12:45 PM. P. Ex. 21,
24. Then, as Nurse Osborne was going to her desk, Nurse Witt came on the
hall, which suggests that Nurse Witt appeared on the scene some time after
12:45. P. Ex. 10. (14) On the other hand, in her statement, the Director of Nursing,
Denise Callahan RN, says that she first learned of a potential problem
at 11:30 AM when Nurse Osborne told her that Nurse Keady needed help with
the medication pass. She sent Nurse Witt to assist. According to Nurse
Callahan, at about 11:45 AM, Nurse Witt called, asking her to check Resident
3 to see if she needed to be sent to the hospital. Nurse Callahan found
Resident 3 "unresponsive, face flushed, diaphaetic [sic?], with respirations
rapid," and instructed Nurse Witt to transfer her immediately. P. Ex.
9. According to Nurse Witt's statement, at 11:30 AM, DON
Callahan asked her to assist with the morning medication pass because
Nurse Keady was having difficulty administering medications on a timely
basis. CMS Ex. 15. Resident 3 had not received her 9:00 AM medications
and Nurse Witt found her in respiratory distress, with fluctuating consciousness,
unresponsive to verbal stimuli. Nurse Witt took her vital signs, gave
her the 9:00 AM nebulizer treatment, and increased her oxygen. She called
Nurse Keady who told her that she had called the doctor at 9:30 and received
orders at 10:30 AM for stat lab work, chest x-rays, and Rocephen, which
she claimed she had given. At about 11:45 AM, according to Nurse Witt's
statement, she saw Dr. Casella and asked him to check Resident 3, while
she called the attending physician. At the same time, Resident 1 was found
unconscious, her blood sugar level not registering,
(15) and Resident 2 was having symptoms of low blood sugar.
Dr. Casella gave orders for Lasix and "to insert a heparin loc." Nurse
Witt administered the IM Lasix, and Dr. Casella told her to arrange for
transportation to the emergency room. According to Nurse Witt, Resident
3 was transferred at 12:45. CMS Ex. 15, at 1 - 3. Other records indicate that staff placed a call to Dr.
Grote for an order to transport Resident 3 to the emergency room. While
the call was being placed, Dr. Casella, a facility doctor, arrived and
was directed to the resident room to assess her condition. He described
her as "critical, death probable." P. Ex. 14. He wrote orders for an injection
of Lasix, for oxygen, for IV Lasix, and for an IM injection of Decadron
stat (to be administered immediately). Tr. at 53. According to the transfer
form, the IM Lasix was administered at 12:30 PM. P. Ex. 15. Neither the
IV Lasix, nor the IM Decadron were provided. In an addendum to her statement,
Nurse Witt indicates that she had not inserted the "hep-loc" because of
the decision to transport Resident 3 to the hospital, and that she was
not aware of the written orders for IV Lasix and Decadron. CMS Ex. 15
at 8. The physician's order to transfer indicates that it was received
at 12:55 PM, but the record does not reliably establish the time Resident
3 was transferred. Assuming the transfer order is correct (P. Ex. 14),
Nurse Witt's assertion that Resident 3 was transferred at 12:45 PM is
likely incorrect. Resident 3 arrived at the hospital with a blood sugar
level of 19 and was diagnosed with profound hypoglycemia and exacerbation
of congestive heart failure. CMS Ex. 3, at 3; P. Ex. 16. She nevertheless
survived and returned to the facility, a readmission note indicating,
among other diagnoses, "insulin induced diabetic coma." P. Ex. 13, at
3. Contrary to Petitioner's suggestions, the statements from
Nurses Keady and Witt were not taken independently. See
P. Brief at 11. According to Administrator Brown's statement, on July
29, the same day they wrote their statements, the three met and discussed
the events of July 28. P. Ex. 7; see
CMS Ex. 15, at 6. The record is silent as to whether DON Callahan or Nurse
Osborne discussed with anyone the events of the day prior to writing their
statements. So, on the one hand, we have the time sequence suggested by
Nurse Osborne's statement and the treatment notes of Residents 1 and 2,
which are not inconsistent with the physician's order sheet; on the other
hand, we have the time table suggested by Nurses Keady, Callahan, and
Witt. Inasmuch as Nurses Keady and Witt discussed the incidents before
preparing their statements, I do not find them inherently more reliable
than Nurse Osborne's and the treatment records. Petitioner also claims,
based on the thinnest of evidence, that between 9:00 AM and 11:30 AM someone
drew Resident 3's blood. CMS challenges the reasonableness of that inference.
However, I need not resolve these conflicts since, under all scenarios,
staff did not give Resident 3 her 9:00 AM medications, did not follow
Dr. Casella's orders for IV Lasix and Decadron, and allowed her condition
to deteriorate to the point of "critical, death probable" before considering
a life-saving transfer to a hospital. In addition, CMS has demonstrated
that the facility failed to administer, within acceptable time parameters,
medications to 9 other residents and that it administered insulin overdoses
to 4 residents. Such failures constitute neglect.
(16) I next consider whether these findings of neglect constitute
a deficiency under 42 C.F.R. � 483.13(c).
42 C.F.R. �
483.13(c) requires that the facility develop and implement written policies
and procedures prohibiting resident neglect. It "addresses a deficiency
related to lack of an effective policy as opposed to one directed at the
occurrence of neglect itself." Emerald
Oaks at 17. Petitioner criticizes what it characterizes as CMS'
"expansive" reading and application of the regulation to this case:
P. Brief at
22 - 23. That Nurse Keady may have been "trying" to provide appropriate
services hardly furthers Petitioner's case. In fact, it suggests that
her numerous errors were attributable to the facility's systemic failure
to provide the kind of support and training she needed to perform her
job adequately. As the appellate panel pointed out in Emerald
Oaks, responsibility for the neglect of a resident, and for implementation
of a policy to forestall such neglect, does not stem solely from the actions
of a single nurse. The Board there specifically rejected a facility's
similar effort to evade its own responsibility by placing blame on the
unquestionably inadequate performance of one employee. There, the facility
claimed that its deficiencies stemmed from the actions of one nurse, who
had not been trained properly and who acted "so far outside her duties
that she lost her license." Id.
at 7. Rejecting this notion, the Board pointed out that the nurse was
acting within the scope of her employment responsibilities, which were
to provide care for the residents.
Id.
at 7 n.3. Nor do I find
any support in the text of the regulation or elsewhere for the proposition
that deficiencies cited under the quality of care or other regulation
may not also constitute deficiencies under 42 C.F.R. � 483.13(c). Just
the opposite is true: if the facility has not implemented a policy to
prevent neglect, and its residents are neglected, it is unlikely that
they have been provided care and services sufficient to attain or maintain
the "highest practicable physical, mental, and psychosocial well-being."
One would therefore expect to see deficiencies cited under other regulations
in addition to section 483.13. As here, the question might be academic
since those deficiencies cited under other regulations could well sustain
the penalties imposed. However, that fact does not mean that the facility
satisfies the requirements of section 483.13. There has been
little appellate discussion of � 483.13. The Emerald
Oaks panel considered the issue before them one of first impression.
There, CMS cited the facility under � 483.13 because one resident was
not adequately monitored to prevent injury, and his physician was not
notified of significant changes in his condition. Petitioner made arguments
similar to those raised by Petitioner in this case: that the regulation
does not prohibit neglect per
se, but addresses a requirement
to develop and implement a policy, and that a finding of neglect cannot
be supported by taking isolated events out of context. The Board noted
that implementing policies "clearly means something more than maintaining
a paper file of documents without actually regulating staff actions,"
and found that the ALJ made no error of law in drawing the inference that
"sufficient examples of neglect can demonstrate lack of implementation
of an anti-neglect policy." Emerald
Oaks at 18. As set forth
above, the deficiencies here go beyond "isolated events taken out of context."
CMS has demonstrated significant instances of neglect, involving multiple
residents. Reasonably interpreted, those facts evidence Petitioner's failure
to implement an effective anti-neglect policy. Petitioner offered virtually
no evidence, and certainly no reliable evidence, showing what systems
it had in place to prevent neglect. It did not point to evidence of written
policies nor explain how such policies were implemented, the same types
of evidentiary shortcomings criticized by the Emerald
Oaks panel when it affirmed the ALJ finding of substantial noncompliance
with � 483.13(c). Id. Thus, CMS has met its burden of setting forth a prima facie case that Petitioner failed to implement anti-neglect policies. Petitioner has not come forward with evidence to refute that case. (17) I therefore conclude that the facility was out of compliance with 42 C.F.R. � 483.13(c).
I next consider
whether CMS' immediate jeopardy finding is "clearly erroneous." 42 C.F.R.
� 498.60(c)(2). Immediate jeopardy exists if the facility's noncompliance
has caused or is likely to cause "serious injury, harm, impairment, or
death to a resident." 42 C.F.R. � 488.301. As noted above, immediate jeopardy
can exist regardless of the scope and severity of the deficiency, so long
as the deficiency involves a potential for more than minimal harm. Lake
City Extended Care Center, DAB No. 1658, at 17 (1998). Although Petitioner makes some attempt to minimize the seriousness of the harm caused by the overdoses ("no evidence that the resident's respiratory problems were caused or exacerbated by her insulin overdose and subsequent hypoglycemia" P. Brief at 15), it is pointless to argue that the significant nursing errors described above did not cause the affected residents serious harm, and did not have the potential for causing even greater harm. (18) Among other injuries, the residents suffered significant adverse reactions to the insulin overdoses. Resident 1 was found unresponsive and foaming at the mouth. Resident 2 was found slumped in her chair with blood sugar level of 31. Resident 3 was admitted to the hospital, with profound hypoglycemia. Resident 4 was found unresponsive in bed with a large skin tear caused by a fall against a door. Moreover, a finding of immediate jeopardy is not contingent on a finding of actual harm, but encompasses situations where there is a likelihood of serious harm. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001). Failure to administer medications as prescribed, along with the other nursing deficiencies, unquestionably creates the likelihood of serious harm. Thus, inasmuch as the facility's deficiencies caused actual harm, and had the potential to cause even more serious harm, I do not consider erroneous CMS' finding of immediate jeopardy.
Petitioner concedes that one of its staff members, who was not licensed , "made significant professional errors that caused injury to as many as four residents on July 28, 1999," but characterizes the problem as a "single error or series of errors by a single nurse on a single occasion." From this, Petitioner argues that, since the deficiencies revolved around the errors of one employee who did not return to the facility after July 28, CMS may not find noncompliance at the time of the survey (August 2, 1999) and should not have imposed a CMP for that day nor any of the 10 subsequent days. (19) I do not accept the proposition that CMS' failure to impose the penalty at the earlier time precluded it from imposing any remedy at all. First, the facility's problems went well beyond a single nursing error. As Petitioner acknowledges, its regular use of agency nurses poses considerable risk:
P. Reply Brief
at 14 n.9. For this reason, if using an agency nurse, the facility needs
adequate systems in place to monitor qualifications, and to provide orientation
and supervision. None of these systems were in place on July 28, and the
facility has not demonstrated adequate correction prior to August 12.
See Fairfax Nursing Home, Inc., DAB No. 1794, at 19 (2001). (Adopting
a protocol without taking sufficient steps that it will be followed is
inadequate to meet the regulatory requirement that the facility ensure
that residents attain and maintain the highest practicable physical well-being). Moreover, under
the regulatory scheme, any deficiency that has a potential for more than
minimal harm is necessarily indicative of problems in the facility that
need to be corrected. Lake City Extended Care Center, DAB No. 1658, at
14 (1998). Since I found that the incidents in question have the potential
for more than minimal harm, I must also find that the facility was out
of compliance "from the date of the completion of the survey in which
this incident was cited until the date of the resurvey in which substantial
compliance was established." Emphasis added; id. at 14 - 15. Substantial
compliance means not only that the surveyors found no other incidents,
but also that the facility has implemented a plan of correction designed
to assure that no such incidents occur in the future. No findings that
the facility violated the standard of care between these dates are required
in order to find the facility out of substantial compliance, nor can evidence
of other incidents in which the facility met the standard of care change
the fact that it was out of substantial compliance. Lake City, at 15.
See also Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002) ( The
burden is on the facility to prove that it has resumed complying with
program requirements, not on CMS to prove that the deficiencies continued
to exist after they were discovered.); Asbury Center at Johnson City,
DAB No. 1815, at 19 - 20 (2002) ("[A] facility's return to substantial
compliance must usually be established through a resurvey, and in a situation
involving inadequate supervision, requiring such a resurvey seems wise.");
Cross Creek Health Care Center, DAB No. 1665 (1998). I therefore conclude that because the facility had not implemented a plan of correction designed to assure that no such incidents occur in the future, CMS appropriately found it out of substantial compliance at the time of the survey and thereafter.
Having found
a basis for imposing a CMP, I now consider whether the amount imposed
is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f).
Emerald Oaks at 10; CarePlex of Silver Spring, DAB No. 1683, at 13 - 17
(1999). In its main brief, Petitioner argues that I lack the authority
to make such finding "de novo" where CMS has not offered evidence that
it considered those regulatory factors. Petitioner suggests that not assessing
the manner in which CMS applied the � 488.438 criteria means that CMS
has "unbridled discretion to impose any CMP (i.e. seize any amount of
the nursing facility's property) it chooses, rendering 42 C.F.R. � 488.438(f)
a nullity." P. Brief at 34. Petitioner acknowledges the ALJ's contrary
decision in Emerald Oaks, DAB CR801 (July 26, 2001), but asserts that
the judge "fundamentally misread" the Medicare statute and DAB precedent. Petitioner's
position was fully addressed and rejected by the appellate panel in Emerald
Oaks. Citing a line of cases, the Board there reaffirmed its rejection
of the notion that the ALJ must review CMS' internal process in setting
a CMP amount. Emerald Oaks at 11; see also Capitol Hill Community Rehabilitation
and Specialty Care Center, DAB No.1629 (1997); South Valley Health Care
Center, DAB No. 1691 (1999) .
Emerald Oaks at 13. So, in reaching a decision on the reasonableness of the CMP, I may not look into CMS' internal decision-making processes. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS' factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS' discretion. Community Nursing Home, DAB No. 1807, at 22, et seq. (2002); CarePlex, DAB No. 1638, at 8.
CMS imposed a penalty of $5,000, which is at the lower end of the mandatory range ($3,050 to $10,000) for immediate jeopardy situations. With respect to the � 488.438(f) factors, the record is silent as to the facility's compliance history and financial condition. However, the seriousness of the deficiencies and the facility culpability justify the imposition of a penalty above the minimum, and I am, therefore, not able to find CMS' determination unreasonable. CONCLUSION For the reasons discussed above, I uphold CMS' determination that from August 2, 1999, through August 11, 1999, the facility was not in substantial compliance with program participation requirements for Staff Treatment of Residents, Resident Assessment, Quality of Care, and Administration. The facility's deficiencies posed immediate jeopardy to resident health and safety, and the amount of the civil money penalty imposed - $5,000 per day for 10 days ($50,000 total) - is reasonable.
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JUDGE | |
Carolyn Cozad Hughes Administrative Law Judge
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FOOTNOTES | |
1. Resident 3 is sometimes referred to as C.J. See P. Ex. 1. 2. The parties disagree as to whether and to what degree Nurse Keady monitored Resident 3's condition; however, as discussed below, no reliable evidence in the record indicates that she or any other staff provided adequate treatment until after 11:30 AM. 3. Petitioner, without citation to the record, asserts certain peripheral "facts" regarding Nurse Keady's background and experience that are simply not supported. Aside from the limited hearsay information supplied by Surveyor Bennett (whose trainee spoke to someone from the employment agency), the record says little about Nurse Keady's actual qualifications or how she was authorized to practice as an LPN in New York. Tr. at 77. The evidence in this record establishes only that Petitioner regularly employed temporary staff, which it obtained from an agency, and that Nurse Keady was an agency employee who had been a home health aide until about one month before she first worked at the facility, when she changed her status to LPN. Tr. at 41, 77. The record is silent as to how or why this change in status occurred. Contrary to Petitioner's inferences, nothing in the record suggests that Nurse Keady worked at St. Clare's Hospital in any capacity. Petitioner has produced an agreement between the facility and an organization called St. Clare's Home Care, the agency that apparently supplied the facility with temporary staff, including Nurse Keady. P. Ex. 44. 4. I discuss at length below how evident this was on July 28 , 1999. 5. It also possible that failure to sign that the medication has been given may in fact indicate that the medication was not given, and the nurse may not accurately remember whether she has given it or not. 6. Based on this silence, Petitioner suggests, without providing any supporting evidence, that Nurse Keady performed competently on those days. In fact, the record simply does not tell us what went on on those days, and no inferences may be drawn. Moreover, even if her performance were adequate on those specific days, she was still unlicensed, and had already demonstrated significant difficulty in coping with the demands of the job. Nor am I convinced that a facility is entitled to notice of staff incompetence before it can be held accountable for their errors. Although not necessary to reach that issue here, it seems that a reasonable distinction could be drawn between situations involving resident accidents, where the facility is not required to "be a guarantor against unforeseeable occurrence (Koester, DAB No. 1750, at 25 - 26; Woodstock Care Center, DAB No. 1726, at 25 (2000)) and those involving instances of staff misconduct or error. A provider is simply responsible for the adequacy of its staff. 7. Resident 1 is also referred to as A.K. See P. Ex 1 8. Resident 2 is also referred to as S.B. See P. Ex 1. 9. Resident 4 is also referred to as M.L. See P. Ex 1. 10. Inasmuch as I conclude that the facility's deficiencies constitute substantial noncompliance under 42 C.F.R.�� 483.20 and 483.25, without regard to 483.13(c), this determination is somewhat academic. 11. In her written statement, Interim Administrator, Janice Brown, indicates that on July 29, she and Nurse Witt discussed with Nurse Keady the events of July 28. After their discussion, she instructed Nurse Keady to write "a statement of the events of her shift the previous day." P. Ex. 7. This statement is apparently found at Petitioner's Exhibit 8, the date on that document referring to the date of the incidents described, not the date that it was drafted. 12. In any event, the language of the third page entries is repeated in the survey report form, so the surveyors likely reviewed the complete document. See CMS Ex. 3, at 2 (indicating the observation was made at 11:30 AM by the RN called to assist in providing medications. Also indicating that the ordered Decadron was not administered). 13. Petitioner offered no evidence as to the time that lunch trays are delivered, which could have been useful in pinpointing the times in Nurse Osborne's statement. 14. Nurse Osborne's statement refers to numerous staff who witnessed these events, but Petitioner produced no statements from them as to the timing, and, of course, none of these individuals were called as witnesses. 15. Again, Resident 1's treatment record indicates she was found unconscious at 12:45 PM. P. Exs. 21, 24. 16. Nor am I convinced that the facility subsequently identified its problems in a timely fashion. Diana Matthews, the LPN who reported to the Newtonian Unit for the 3:00 PM to 11:00 PM shift, writes that she was not aware that Resident 2 had become hypoglycemic during the day shift because she had not been given a report on her condition. She only became aware of the episode when she began charting at midnight. P. Ex. 4. Further, even though f acility policy dictated that the outgoing and incoming nurse count the syringes at every shift (Tr. at 54), the syringes were not counted between the day and evening shifts, so evening staff did not know why the residents were so ill until about midnight when the outgoing evening and the incoming night nurse counted syringes. Tr. at 54; P. Ex. 4. 17. Petitioner correctly asserts that CMS did not complain specifically about its written policies and procedures. However, this fact does not establish compliance with section 483.13, and by suggesting that it does, Petitioner has reversed the parties' respective burdens. The fact of neglect satisfies CMS' prima facie burden. Petitioner must then demonstrate its compliance. Hillman Rehabilitation Center, DAB No. 1665 (1998); see Emerald Oaks at 9, et seq., for a thorough discussion of the correct analytical framework for ALJ hearings on disputed issues of fact. 18. I also find pointless any effort to determine, based on the record before me, the relative contributions to Resident 3's rapid decline played by 1) her receipt of the insulin overdose, 2) the facility's failure to administer her 9:00 AM respiratory medications, and 3) other causes. Whether the nursing failures, individually or in combination, were directly responsible, each had the potential for causing irreparable harm, so the standard is met. 19. Indeed, CMS might have imposed a CMP starting July 28, when the actual harm occurred, or even as early as July 2, when the facility first allowed an unlicensed and unqualified person to perform the duties of an LPN. | |