$05:Civil Money Penalty
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
______________________________
In the Case of:
National Hospital for Kids in Crisis,
Petitioner,
- v.-
Health Care Financing Administration.
DATE: March 5, 1996
Docket No. C-94-333
Decision No. CR413
DECISION
In this decision I conclude that, on June 24, 1993, the Health Care
Financing Administration (HCFA) properly determined not to certify
Petitioner as a participant in the Medicare program based on its
finding that Petitioner was not complying with a condition of
participation in Medicare. The effect of my decision is to sustain
HCFA's later determination that Petitioner first became
eligible to participate in Medicare on October 25, 1993.
I. Background
The facts and law which I recite as background to this case are not
disputed by the parties. Petitioner is a nonprofit hospital that
provides care to children who are hospitalized for treatment of
mental disorders. Petitioner applied to participate in the
Medicare program as a psychiatric hospital.
An applicant for participation in Medicare may not participate in
the program until HCFA certifies that the applicant is complying
with all Medicare participation requirements. 42 C.F.R. 489.13.
HCFA directs that an applicant for participation in Medicare be
surveyed in order to ascertain whether the applicant is complying
with participation requirements. On May 24 - 25, 1993, Petitioner
was surveyed by two psychiatric consultants who had been retained
by HCFA. The surveyors evaluated Petitioner's operations pursuant
to regulations which govern Medicare participation of psychiatric
hospitals.
The regulations that govern Medicare participation of psychiatric
hospitals are contained in 42 C.F.R. Part 482. These regulations
describe three levels of requirements that a psychiatric hospital
must comply with in order to participate in Medicare. These three
levels of requirements are known as "conditions," "standards,"
and
"elements" of participation. Conditions of participation are
fundamental requirements of participation. For example, 42 C.F.R.
482.61, which prescribes the medical records that must be
maintained by a participating psychiatric hospital, states as a
condition of participation that the medical records maintained by
a psychiatric hospital must permit determination of the degree and
intensity of treatment provided to patients.
A standard of participation is a subpart of a condition of
participation. For example, a standard of the medical records
condition, contained in 42 C.F.R. 482.61(a), is that medical
records must stress the psychiatric component of the patient's
record. An element of participation is a subpart of a standard.
Thus, 42 C.F.R. 482.61(a)(1) provides, as an element of the
preceding standard, that identification data in a patient's medical
record must include that patient's legal status. 1/
HCFA will not permit an applicant to participate in Medicare until
the applicant corrects any deficiency identified during a survey.
42 C.F.R. 489.13. HCFA furnishes the applicant with a written
notice of any deficiency ascertained at a survey. See 42 C.F.R.
488.24, 488.26. 2/
An applicant who is found not to be in compliance with a standard
or element of certification may obtain HCFA's permission to
participate if it assures HCFA that it is making the correction.
The applicant may submit a plan of correction to HCFA. 42 C.F.R.
488.28(a). HCFA will permit an applicant who submits an
acceptable plan of correction to participate, as of the date that
the deficiency is corrected, or on the date of the plan of
correction, whichever is the earlier date. 42 C.F.R. 489.13(b).
HCFA does not provide an applicant who fails to comply with a
condition of participation the opportunity to submit a plan of
correction. See 42 C.F.R. 488.28(a). An applicant who fails to
comply with a condition of participation must submit a new
application for participation to HCFA, and HCFA will have the
applicant resurveyed. The applicant will be certified only after
the resurvey, assuming that the resurvey establishes that the
applicant is complying with all conditions of participation and
that no additional deficiencies are identified. The necessity for
a resurvey to establish compliance with a condition of
participation means that, often, substantial time will elapse
between identification of a condition-level deficiency at the first
survey and the eventual date of certification.
The consultants who surveyed Petitioner on May 24 - 25, 1993 found
that Petitioner was not in compliance with a Medicare condition of
participation stated in 42 C.F.R. 482.62, which describes
special staffing requirements for psychiatric hospitals. HCFA
accepted this finding, and, on June 24, 1993, it informed
Petitioner that Petitioner did not meet the special staffing
condition of participation in Medicare.
Consistent with HCFA's procedures, Petitioner was not afforded the
opportunity to submit a plan of correction to HCFA to show that the
condition-level deficiency had been corrected. HCFA advised
Petitioner that Petitioner had a right to request reconsideration
of HCFA's determination that Petitioner did not meet the special
staffing condition. Petitioner requested reconsideration. While
this request was pending with HCFA, Petitioner reapplied to HCFA to
be certified as a participating provider. On September 24, 1993,
Petitioner was resurveyed by consultants working on behalf of HCFA.
The surveyors concluded that, as of that date, Petitioner was
complying with all Medicare conditions of participation. However,
they concluded also that Petitioner was not complying with elements
of standards of participation contained in 42 C.F.R. 482.61(a),
the regulation which governs medical records maintained by
psychiatric hospitals.
HCFA afforded Petitioner the opportunity to submit a plan of
correction which addressed the deficiencies in elements of
participation that were identified at the September 24, 1993
resurvey of Petitioner. Petitioner submitted a plan of correction,
which HCFA received on October 25, 1993. On November 2, 1993, HCFA
advised Petitioner that HCFA had accepted the plan of correction.
Petitioner was certified to participate in Medicare effective
October 25, 1993.
Petitioner continued to request that HCFA reconsider its June 24,
1993 determination that Petitioner did not meet a condition of
participation in Medicare. On January 24, 1994, HCFA advised
Petitioner that HCFA was sustaining its June 24, 1993 determination
that Petitioner failed to meet a condition of participation. HCFA
restated that the effective date of Petitioner's participation in
Medicare was October 25, 1993.
Petitioner requested a hearing. In its request, Petitioner
disputed that the deficiencies that were found at the May 24 - 25,
1993 survey were so severe as to establish that Petitioner was not
in compliance with a condition of participation in Medicare.
Petitioner asserted that HCFA should have afforded Petitioner the
opportunity to submit a plan of correction to HCFA to address the
deficiencies that had been identified at the May 24 - 25, 1993
survey of Petitioner.
The case was assigned to me for a hearing and decision. On
September 26 - 27, 1995, I conducted a hearing in Philadelphia,
Pennsylvania. 3/ I base my decision in this case on the record of
that hearing, on the parties' arguments, and on the applicable law.
II. Issue, findings of fact, and conclusions of law
Petitioner concedes that, as of the May 24 - 25, 1993 survey, it
was not complying with all requirements of participation. However,
Petitioner argues that it was complying with all conditions of
participation as of May 24 - 25, 1993. It contends that any
deficiencies which existed as of that date were not so severe as to
be condition-level deficiencies.
Petitioner asserts that HCFA was required to afford Petitioner the
opportunity to submit a plan of correction to address the
deficiencies that were identified at the May 24 - 25, 1993 survey.
4/ Petitioner argues that, had HCFA permitted Petitioner to submit
a plan of correction, Petitioner would have established compliance
with HCFA's requirements of participation by no later than June 30,
1993. Much of the evidence that Petitioner introduced at the
September 26 - 27, 1995 hearing addressed its efforts prior to June
30, 1993 to correct the deficiencies that were identified by HCFA
at the May 24 - 25, 1993 survey of Petitioner.
The issue in this case is whether, based on the May 24 - 25, 1993
survey, HCFA properly determined that Petitioner was ineligible to
participate in Medicare due to a failure by Petitioner to comply
with a condition of participation in Medicare. If HCFA concluded
properly that, as of May 24 - 25, 1993, Petitioner failed to comply
with a condition of participation, then HCFA correctly determined
that Petitioner could not be certified until Petitioner was
resurveyed and found to be in compliance with all participation
requirements.
If Petitioner was not complying with a condition of participation
on May 24 - 25, 1993, then evidence that it offered to show that it
corrected deficiencies prior to June 30, 1993 is irrelevant. On
the other hand, if the deficiencies identified by HCFA as a result
of the May 24 - 25, 1993 survey were not so severe as to be
condition-level deficiencies, then HCFA would have been required
under its regulations to afford Petitioner the opportunity to
submit a plan of correction to HCFA. In that event, evidence
proving that Petitioner corrected the deficiencies prior to the
resurvey conducted on September 24, 1993 becomes relevant.
I make the following findings of fact and conclusions of law
(Findings) which support my decision that, based on the May 24 -
25, 1993 survey, HCFA properly determined that Petitioner was not
complying with a condition of participation. I discuss these
Findings, in detail, below.
1. An applicant for participation in Medicare does not comply
with a Medicare condition of participation where its failure to
satisfy requirements of participation substantially limits that
applicant's capacity to provide care or where that failure
adversely affects the health and safety of patients.
2. A condition-level deficiency exists where the deficiency
results in a potential for harm to patients.
3. It is a condition of participation in Medicare that a
psychiatric hospital have adequate numbers of qualified
professional staff, including nurses, to evaluate patients,
formulate written, individualized comprehensive treatment plans,
provide active treatment measures, and engage in discharge
planning.
4. HCFA's finding of a condition-level deficiency in this
case relies on the plain meaning of the regulation which governs
the professional staff which must be present at a psychiatric
hospital.
5. The facility for which Petitioner sought certification
treats children who are suffering from serious mental problems.
6. Nursing services provided by Petitioner include assessment
of patients' physical and mental status, secluding and restraining
patients when necessary, administering medications to patients, and
monitoring the effects of medications.
7. As of May 24 - 25, 1993, some of the nursing services that
Petitioner provided to its patients were being provided by child
care counselors who did not have the professional training of
nurses and who were not supervised by nurses.
8. As of May 24 - 25, 1993, Petitioner did not have an
adequate number of nurses on duty at its facility to perform all of
the services that should be provided by nurses.
9. As of May 24 - 25, 1993, Petitioner's failure to have an
adequate number of nurses to provide the services that should be
provided by nurses threatened the health and safety of Petitioner's
patients and substantially limited Petitioner's ability to provide
adequate care to patients.
10. As of May 24 - 25, 1993, Petitioner was not complying
with the condition of participation in Medicare governing staffing
in psychiatric hospitals.
III. Discussion
A. Applicable law (Findings 1 - 4)
Under regulations which govern participation in the Medicare
program, a provider or supplier fails to meet a condition of
participation where it manifests deficiencies that are:
. . . of such character as to substantially limit the
provider's or supplier's capacity to render adequate care or which
adversely affect the health and safety of patients; . . .
42 C.F.R. 488.24(a). 5/
In determining the level of a deficiency, it is necessary to
examine the actual or potential impact that the deficiency may have
on an entity's capacity to provide care or on the health and safety
of patients. An entity's failure to comply with the requirements
of a standard or element of a condition of participation also may
be a failure to comply with the overall condition if the failure
substantially compromises the entity's ability to provide care or
adversely affects the health and safety of patients.
Petitioner argues that, in order to show that an entity is not
complying with a condition of participation, HCFA must prove that
a deficiency in that entity's operations is not just potentially
harming, but is actually harming, patients. Petitioner Reply to
HCFA Posthearing Brief at 5 - 6. I do not agree with this
argument. It is not supported by either the language of 42 C.F.R.
488.24(a) or by logical application of that language.
I read the regulation as encompassing not only the circumstance
where demonstrable harm results from a deficiency, but also the
circumstance where the potential for harm results from a
deficiency. The regulation does not state that a condition-level
deficiency exists only where that deficiency is causing actual,
measurable harm to patients. The regulation explicitly provides
that a deficiency will be of a condition level of severity where
the deficiency impairs an entity's capacity to provide adequate
care. A finding of impairment of an entity's capacity to provide
adequate care encompasses both circumstances where the deficiency
causes actual harm to patients and where it creates the potential
for harm to patients. Also, the regulation specifically defines a
condition-level deficiency as being a circumstance that adversely
affects the health and safety of patients. A finding of a
deficiency that adversely affects the safety of patients plainly
would encompass a situation where the deficiency poses a potential
for harm to patients.
Furthermore, it would undermine the purpose of Medicare
certification to read the regulation as defining a condition-level
deficiency to exist only where there is proof of harm to patients.
The purpose of certification is to protect the health and safety of
program beneficiaries from acts and omissions that either cause
them harm or which might cause them harm. It would be contrary to
the purpose of certification to require HCFA to wait until there is
proof of actual harm to patients before taking action against a
deficiency that poses the potential for causing harm.
The condition which HCFA determined Petitioner not to be complying
with is in the regulation which governs the staffing of psychiatric
hospitals that participate i
Medicare. 42 C.F.R. 482.62. The regulation states that a
psychiatric hospital must have:
. . . adequate numbers of qualified professional and
supportive staff to evaluate patients, formulate written,
individualized comprehensive treatment plans, provide active
treatment measures, and engage in discharge planning.
Id. The regulation restates this general requirement as a standard
for hospital personnel. 42 C.F.R. 482.62(a). The regulation
contains a standard governing nursing staff, which requires a
psychiatric hospital to have adequate numbers of registered nurses,
licensed practical nurses, and mental health care workers to
provide necessary care to patients. 42 C.F.R. 482.62(d),
(d)(2).
The regulation does not quantify the numbers of professional staff
that must be on hand to provide services to patients. It states
only that the professional staff must be "adequate" to provide
necessary services.
Petitioner asserts that HCFA premises its determination that
Petitioner failed to comply with the condition in 42 C.F.R.
482.62 on an interpretation of the regulation that departs from the
regulation's plain meaning. Petitioner Posthearing Brief at 5. I
discuss in detail the surveyors' findings which are central to
HCFA's determination below, at Parts III.B. and III.C. However, I
recite the conclusions on which HCFA premises its determination and
the surveyors' findings here so that I may decide Petitioner's
argument concerning HCFA's asserted interpretation of the
regulation.
HCFA determined that Petitioner failed to comply with the standards
contained in 42 C.F.R. 482.62(a) and (d) because Petitioner
did not have an adequate number of nurses on hand to provide
necessary nursing care to patients. HCFA determined that this
failure was so egregious as to substantially limit Petitioner's
capacity to provide care to its patients. HCFA found also that the
deficiency jeopardized the health and safety of Petitioner's
patients. 6/
Central to HCFA's determination is the surveyors' finding that, as
of May 24 - 25, 1993, Petitioner did not have a sufficient number
of nurses on hand to provide all nursing services directly. Also
central is the surveyors' finding that some nursing services were
in fact being provided by child care counselors, who were not
nurses, who were not professionally qualified to provide nursing
services, and who were not supervised by nurses. In sum, the
surveyors found that Petitioner had an inadequate number of nurses
on hand to provide nursing services and that Petitioner was using
non-nursing personnel who were not under the supervision and
control of nurses to provide those services.
Petitioner contends that HCFA interprets 42 C.F.R. 482.62 to
mean that, where a psychiatric hospital employs child care
counselors, the counselors must be supervised by nurses.
Petitioner Posthearing Brief at 5. Petitioner asserts that the
deficiency identified by HCFA under HCFA's reading of the
regulation is that Petitioner did not have its child care
counselors supervised by nurses. Petitioner argues that the
regulation is silent as to the supervisory controls that a
psychiatric hospital must exercise over its child care counselors.
Petitioner thus argues that HCFA premises its determination as to
the adequacy of Petitioner's professional staff on an
interpretation of 42 C.F.R. 482.62 that departs from the plain
meaning of the regulation.
Petitioner argues additionally that, inasmuch as HCFA's
interpretation of the regulation is not within the regulation's
plain meaning, then HCFA cannot reasonably hold Petitioner
accountable to that interpretation. Petitioner Posthearing Brief
at 5. Alternatively, Petitioner argues that HCFA cannot reasonably
hold Petitioner accountable to HCFA's interpretation without first
providing Petitioner with notice of that interpretation. Id.
Petitioner mischaracterizes HCFA's determination that Petitioner
failed to comply with 42 C.F.R. 482.62. The gravamen of HCFA's
determination is that Petitioner failed to employ an adequate
number of nurses to provide necessary nursing services. HCFA's
determination is based on the plain meaning of 42 C.F.R. 482.62.
The plain meaning of the regulation is that a psychiatric hospital
must have adequate numbers of professionals on hand, including
nurses, to perform the duties that are within the province of the
professional staff. Contrary to Petitioner's characterization of
HCFA's determination, HCFA did not determine that, under 42 C.F.R.
482.62, child care counselors necessarily must be supervised by
nurses. HCFA did not determine that there exists any particular
supervisory requirement in the regulation applicable to child care
counselors. Where child care counselors perform duties that are
not nursing duties, there would be no need for them to be
supervised by nurses.
HCFA determined that Petitioner may not make up for a shortfall in
nursing personnel by assigning nursing duties to non-nurses who are
not under the supervision and control of nurses. Under HCFA's
analysis, child care counselors need to be supervised by nurses
only if they are being used to assist nurses in the performance of
nursing duties. That is entirely consistent with the regulation's
requirement that there be adequate professional staff, including
nurses, to perform the duties assigned to that staff.
Petitioner corrected its nursing staff deficiency by placing its
child care counselors under the direct supervision and control of
nurses. The child care counselors became assistants to the nurses
and were used to augment nurses providing services. Ultimately,
HCFA accepted this arrangement as an adequate way to meet the
nursing staff requirements of 42 C.F.R. 482.62. P. Ex. 19. The
fact that HCFA accepted this restructuring of Petitioner's
operations as a way to correct a deficiency in those operations
does not suggest that HCFA interpreted the staffing regulation to
require this arrangement. Petitioner could have corrected the
deficiency by hiring additional nurses and by assigning only
non-nursing duties to child care counselors.
It is unnecessary for me to decide Petitioner's argument that HCFA
failed to provide Petitioner with adequate notice of HCFA's
interpretation of 42 C.F.R. 482.62, given my conclusion that
HCFA's determination comports with the plain meaning of the
regulation. I would note however, that I am not persuaded that
HCFA was obligated in this case to provide Petitioner with advance
notice of its interpretation of the regulation, assuming the
interpretation to be reasonable.
I have concluded in other cases that HCFA is obliged to give a
provider notice of its interpretation of a regulation before using
that interpretation as grounds for finding a condition-level
deficiency and terminating the provider's participation in
Medicare, where the interpretation, albeit reasonable, is not
evident from the language of the regulation. Hospicio en el Hogar
de Utuado, DAB CR371 (1995). My rationale is that it would not be
reasonable for HCFA to terminate a provider who has an ongoing
relationship with HCFA, where HCFA's interpretation of a regulation
is not apparent from the face of the regulation, without HCFA first
giving the provider notice of that interpretation. Here, however,
Petitioner did not have an ongoing provider relationship with HCFA.
As of May 24 - 25, 1993, it was an applicant for provider status.
The regulations provide plainly that an applicant for participation
in Medicare may not be certified as a participating provider until
it complies with all participation requirements. 42 C.F.R.
489.13.
B. The facts supporting HCFA's determination
(Findings 5 - 9)
I ruled that HCFA had the burden of proving, by a preponderance of
the evidence, the facts on which it based its determination that
Petitioner was not complying with a Medicare condition of
participation. HCFA established the facts on which I base my
Findings 5 - 9 by a preponderance of the evidence.
The evidence offered by HCFA consists largely of the testimony of
the two surveyors who conducted the May 24 - 25, 1993 survey,
Chester A. Woffard, R.N. (Tr. at 67 - 176) and Raymond E. Ackerman,
M.D. (Tr. at 177 - 225). 7/ Dr. Ackerman testified additionally as
a rebuttal witness for HCFA (Tr. at 408 - 413). I find these
witnesses to be credible and their testimony to be persuasive.
The testimony of Mr. Woffard and Dr. Ackerman includes observations
that the surveyors made concerning the way in which Petitioner was
providing care to its patients. Their testimony includes also
opinions on the questions of whether Petitioner had an adequate
number of nurses on its staff to perform all nursing duties,
whether duties assigned to child care counselors were, in fact,
nursing duties and, whether Petitioner's staffing arrangements
potentially harmed patients.
Mr. Woffard is a registered nurse with a master's degree in
psychiatric nursing. P. Ex. 12 at 1. He has many years of
experience in the field of psychiatric nursing, including extensive
supervisory experience. Id. Mr. Woffard has performed
certification surveys on behalf of HCFA since 1983, and his
experience as a surveyor includes many surveys of psychiatric
hospitals for the purpose of determining whether the hospitals are
complying with Medicare staffing requirements. Id.
Dr. Ackerman has been board-certified as a psychiatrist since 1969.
HCFA Ex. 2 at 1. He has performed surveys on behalf of HCFA or its
predecessor since 1977. Tr. at 178. He has surveyed more than 125
hospitals for compliance with Medicare participation requirements,
including professional staffing requirements. Id. at 178 - 179.
Mr. Woffard is qualified to testify about the duties that fall
within the province of nurses and about the risks that are inherent
in assigning nursing duties to non-nurses. Both Mr. Woffard and
Dr. Ackerman are qualified to testify as to whether duties that
were assigned by Petitioner to child care counselors were in the
nature of nursing duties. Both of these witnesses are qualified to
opine as to the effect of Petitioner's professional staffing
arrangements of the welfare of patients.
Petitioner now argues that I should not accept the opinions of Mr.
Woffard and Dr. Ackerman as expert opinions. Petitioner Reply to
HCFA Posthearing Brief at 2. Petitioner premises this argument on
HCFA's failure at the September 26 - 27, 1995 hearing to announce
explicitly that it intended to offer the opinions of these two
witnesses as experts. I do not find that HCFA's failure at the
hearing to announce explicitly that it intended to offer the expert
opinions of Mr. Woffard and Dr. Ackerman bars me from considering
the expert opinions that were offered by these witnesses and
attaching to those opinions the weight that is due to them.
Petitioner cannot claim credibly that it was ambushed by HCFA. It
was obvious at the hearing that HCFA intended that these witnesses
be considered as experts in the way psychiatric hospitals provide
services to their patients. Petitioner had ample opportunity to
cross-examine these witnesses on their expertise and their opinions
and to impeach their testimony.
Mr. Woffard and Dr. Ackerman are qualified to opine whether
Petitioner's staffing arrangements were inadequate or whether they
created a potential for harm to patients. The witnesses are not
qualified to opine as to whether the inadequacies they attested to
prove a failure by Petitioner to comply with the requirements of 42
C.F.R. 482.62, or whether the potential for harm resulting from
those inadequacies meets the definition of a condition-level
deficiency contained in 42 C.F.R. 488.24(a). A finding as to
whether facts prove a failure to comply with the terms of a
regulation, or whether the facts prove a condition-level deficiency
requires an application of law to evidence which the witnesses are
not qualified to make.
In many respects, the findings made by Mr. Woffard and Dr. Ackerman
as to the way in which Petitioner organized its professional staff
are not challenged by Petitioner. As I discuss below, a central
finding by the surveyors is that nurses on duty for Petitioner did
not have supervisory authority over child care counselors. This
central finding is corroborated by Petitioner's own witnesses.
See, e.g., P. Ex. 17.
However, Petitioner denies that the effect of its organization of
staff was to pose a potential for harming Petitioner's patients.
In concluding that the potential for harm existed, I have
considered carefully the testimony of Petitioner's witnesses,
especially that of Petitioner's expert witness, Christine M.
Doleski, R.N. (Tr. at 377 - 404).
Ms. Doleski, like Mr. Woffard, is a registered nurse with a
master's degree in psychiatric nursing and substantial experience
in the field of psychiatric nursing. P. Ex. 13; Tr. at 379. I
find her well qualified to testify as an expert. Furthermore, I
find her testimony to be credible. However, I am not persuaded by
Ms. Doleski's testimony that Petitioner rebutted the key concern
raised by HCFA's surveyors, that the organization of Petitioner's
professional staff created a potential for harming patients. I
discuss my reasons for this conclusion at Part III.B.4. of this
decision.
1. Petitioner's facility and patients (Finding 5)
As of May 24 - 25, 1993, the facility for which Petitioner was
applying for certification as a psychiatric hospital consisted of
a building wing which was housing approximately 12 patients. P.
Ex. 18 at 1. At that time, the facility consisted of a nursing
station, eight bedrooms, some of which were occupied by one patient
and some of which were occupied by two patients, and two contiguous
rooms which were used for patient therapy and activities. Id.
Then, and now, Petitioner's facility treats children who range in
age from about six to about 18 years. Tr. at 246. The duration of
a typical patient stay, then, and now, is about three weeks. Tr.
at 249.
Petitioner's patients are seriously ill. Patient diagnoses include
major depressive disorders, personality disorders, schizophrenia,
or other psychotic disorders, including drug-induced disorders.
Tr. at 250. In a majority of cases, the patients pose threats,
either to themselves or to others. Tr. at 251. Some patients
require continuous, direct observation and supervision. See P. Ex.
17 at 3; Tr. at 137. At times, it is necessary to seclude
(isolate) a patient or to physically restrain a patient. See P.
Ex. 17 at 3; Tr. at 136. Most of the patients are on medication.
Tr. at 187. The medications administered to the patients may have
side effects which affect the patients' physical and mental
activities. Id. Some of the patients suffer from disorders,
including epilepsy, which may produce seizures, and organic brain
disorders. Tr. at 187 - 188.
2. Nursing services provided by Petitioner
(Finding 6)
Petitioner asserts that HCFA has not offered a definition of what
comprises nursing services. Petitioner Reply to HCFA Posthearing
Brief at 4. Petitioner argues that HCFA cannot hold Petitioner
accountable for failing to comply with the regulation governing a
psychiatric hospital's professional staff, because HCFA has never
defined what comprises nursing services. Id.
I disagree with this assertion. This case focuses on HCFA's
allegation that Petitioner lacked a sufficient number of nurses to
perform certain specific nursing services. HCFA identified what
nursing services are at issue and proved by a preponderance of the
evidence that these services fall within the generally accepted
understanding of what comprises nursing services at a psychiatric
hospital. Petitioner did not argue that any of these services are
not nursing services, nor did it offer evidence to rebut the
evidence that HCFA introduced to prove that the services are
nursing services.
It is true that the regulation which governs staffing at
psychiatric hospitals does not define nursing services. See 42
C.F.R. 482.62(d). Nor did HCFA attempt through the presentation
of evidence to offer a comprehensive definition of what comprises
nursing services. However, Mr. Woffard and Dr. Ackerman
persuasively defined the services which I describe in this section
to constitute nursing services which a psychiatric hospital should
assign to its nurses. Tr. at 88 - 89, 185 - 191.
Petitioner cannot now assert credibly that it could not have been
expected to know that these services should be provided by nurses.
The services fall within the scope of services that nurses are
licensed to provide. Tr. at 91. Additionally, they fall within
the scope of services that psychiatric hospitals commonly assign to
nurses. Id.
The nursing services which Petitioner provides to its patients
include the monitoring of patients' conditions, the assessment of
patients' mental and physical status, and secluding and restraining
patients when necessary. Tr. at 86, 88 - 91, 185 - 191. These
services fall within the unique professional training and licensure
of nurses.
It is necessary for people who are monitoring the status of
psychiatric patients to be trained and qualified to make informed
judgments about what they are monitoring. Tr. at 187 - 188. For
example, observed behaviors such as restlessness and agitation may
be the consequence of an illness or they may be the side effects of
medication. Id. It is important to be able to differentiate
between possible causes of an observed behavior in order to be able
to make an informed judgment and a recommendation about the
treatment that should be administered to the patient. Nurses
possess the necessary skills and training to make an informed
judgment about the cause or causes of observed behavior. Tr. at
186 - 191.
3. The manner in which Petitioner provided
nursing services (Findings 7 - 8)
As of May 24 - 25, 1993, Petitioner had a total of four registered
nurses providing nursing services to patients. P. Ex. 9 at 43; see
Tr. at 102 - 103. Each of the four nurses was assigned to work a
specific eight-hour shift. P. Ex. 9 at 43. One nurse was assigned
to work the day shift, one nurse was assigned to work the evening
shift, and two nurses were assigned to work the night shift. Id.
Thus, on two of the three shifts there was only one nurse on hand
to provide nursing services to the approximately 12 patients who
were hospitalized at Petitioner's facility.
As of May 24 - 25, 1993, Petitioner did not have an adequate number
of nurses on duty to provide all nursing services. Tr. at 102 -
103. It was not possible for the one nurse who was on duty most of
the time to directly observe all of Petitioner's patients and to
provide nursing services to all of them. Id. Petitioner relied on
child care counselors, who are not nurses, who are not qualified to
provide nursing services, and who were not supervised by nurses, to
provide nursing services.
Petitioner assigned child care counselors to work with the nurse or
nurses on duty on each shift. P. Ex. 9 at 51. Child care
counselors are individuals who are experienced in dealing with
children who suffer from mental illnesses but who lack the training
and licensure of nurses. See P. Ex. 20. Generally, three or four
child care counselors were assigned to the day shift, four or five
child care counselors were assigned to the evening shift, and two
child care counselors were assigned to the night shift. Id.; P.
Ex. 17 at 1.
As of May 24 - 25, 1993, the nurses who were on duty on a shift had
no supervisory authority over the child care counselors who were on
duty with them. P. Ex. 17 at 1; see Tr. at 83. There were no
articulated lines of reporting between the child care counselors
and the nurses. Tr. at 83 - 84. Petitioner organized its nursing
staff and its child care counselor staff under two separate lines
of authority, with each staff having its own supervisors. Tr. at
83 - 84.
That is not to say that there was an absence of communication
between nurses and child care counselors. Individuals on each
staff worked with each other as teams. P. Ex. 17 at 1. The teams
met frequently to discuss the treatments being given to patients
and to develop treatment goals. P. Ex. 17 at 3. Nurses and child
care counselors cooperated closely with each other. P. Ex. 20 at
2 - 3; Tr. at 395 - 396.
However, although the child care counselors may have worked closely
with nurses, and may even have deferred to them, the child care
counselors were not subordinate to nurses, nor were the child care
counselors required to obtain the permission of nurses before
initiating direct patient care. Tr. at 95 - 96; see P. Ex. 17 at
2 - 4. Crisis intervention activities were not under the
supervision of nurses. Tr. at 95. Child care counselors had
authority to initiate decisions to implement seclusion and
restraint of patients without first consulting with, or obtaining
the permission of, nurses. Tr. at 96.
Furthermore, the fact that on two of three shifts there was only
one nurse present meant that Petitioner used child care counselors
to provide one-to-one observation of patients without the
supervision of nurses. HCFA Ex. 4 at 4. One-to-one observation is
used in treating seriously disturbed patients, patients who are
aggressive, suicidal, or in danger of injuring themselves, and
patients who suffer from organic disturbances such as seizure
disorders. Id.
The training and experience possessed by child care counselors did
not qualify them to work unsupervised by nurses to assess a
patient's mental status, to differentiate between symptoms that
might be caused by a patient's conditions or which might be
produced by medications, or to initiate seclusion or restraint of
a patient. Tr. at 86, 88 - 92, 191 - 192. The fact that
Petitioner assigned nursing services, including one-to-one
observation of patients, to child care counselors who were not
supervised by nurses meant that nursing services were being
provided by individuals who were not qualified to provide such
services.
4. The consequences of Petitioner's staffing
arrangement (Finding 9)
There is no evidence that the manner in which Petitioner provided
nursing services to its patients harmed patients. For example,
there is no evidence to show that a child care counselor
inappropriately secluded or restrained a patient or that a child
care counselor misinterpreted the cause of a patient's symptoms,
with detrimental effect to the patient. However, the preponderance
of the evidence is that a potential for harm to patients existed in
the way in which Petitioner provided nursing services as of May 24
- 25, 1993. HCFA Ex. 4; Tr. at 196 - 197.
Petitioner's failure to have an adequate number of nurses to
provide nursing services, or to supervise nursing services provided
by child care counselors, substantially limited Petitioner's
ability to provide adequate care to its patients. Id.
Patients can experience harm from the failure to provide
psychiatric nursing services properly. For example, an incorrect
decision to seclude or restrain a patient can cause harm to that
patient. HCFA Ex. 4 at 3 - 4. Failure to have a nurse perform
one-to-one observation of a patient, or to supervise that
observation, can also cause harm to a patient. Id. at 5.
Petitioner argues that no potential for harm existed from its
delegation of nursing duties to child care counselors who were not
supervised by nurses. Petitioner bases this argument on the close
cooperation that existed between its nurses and child care
counselors as of May 24 - 25, 1993. According to Petitioner, the
close working relationship between the nursing and counseling
staffs assured that the staffs functioned in an integrated manner
and that there was an effective flow of information between child
care counselors and nurses.
I am not persuaded that the close cooperation and information flow
that existed between child care counselors and nurses eliminated
the risk caused by assigning nursing duties to child care
counselors who were not supervised by nurses. Close cooperation
between child care counselors and nurses is not an acceptable
substitute for supervision of child care counselors by nurses,
where such supervision is required. The fact is that child care
counselors were assigned duties that they were not qualified to
perform in the absence of supervision by nurses, and the child care
counselors were not supervised by nurses in performing these
duties. That arrangement created the potential for harm to
patients.
I have carefully considered Ms. Doleski's testimony in reaching my
conclusion that the staffing arrangement utilized by Petitioner as
of May 24 - 25, 1993 was potentially harmful to patients and
substantially limited Petitioner's capacity to provide adequate
care to patients. Ms. Doleski attested to the high degree of
cooperation and teamwork that existed between the child care
counselors and nurses. Tr. at 392 - 393, 395. She asserted that
the staffing arrangement at Petitioner's facility did not impede
the ability of nurses to direct the providing of care to patients.
Tr. at 395.
Ms. Doleski's testimony supports the conclusion that there existed
an excellent working relationship at Petitioner's facility between
child care counselors and nurses. It reinforces the testimony of
members of Petitioner's staff that they cooperated closely with
each other. P. Exs. 17, 20. However, it does not overcome the
conclusion that a potential for harm to patients existed in the way
Petitioner organized its staff. Despite the cooperation attested
to by Ms. Doleski, there remain the facts that child care
counselors were assigned duties that were beyond the scope of their
education and training, and that they were not supervised by nurses
in the performance of those duties. That created the possibility
that a child care counselor could make a decision that harmed a
patient, even if that possibility may have been ameliorated
somewhat by a high level of cooperation among Petitioner's staff.
C. The level of Petitioner's deficiency (Finding 10)
As of May 24 - 25, 1993, Petitioner was not complying with the
condition of participation contained in 42 C.F.R. 482.62.
Petitioner did not have an adequate number of nurses on duty to
provide nursing services to its patients. That failure created a
potential for harm to patients and substantially limited
Petitioner's ability to provide adequate care to its patients.
The consequence of this failure to comply with a condition of
participation is that HCFA was not obligated to accept a plan of
correction from Petitioner, or other assurances from Petitioner
that it had corrected the deficiency, prior to conducting a
resurvey of Petitioner to assure that the deficiency had been
corrected. 42 C.F.R. 488.28, 489.13. Evidence that
Petitioner offered to prove that it corrected the staffing
deficiency prior to the September 24, 1993 resurvey is thus
irrelevant.
As I describe in Part I of this decision, the surveyors found, on
September 24, 1993, that Petitioner had corrected its failure to
comply with the condition of participation contained in 42 C.F.R.
482.62. However, the surveyors found that, as of that date,
Petitioner was not complying with elements of another condition of
participation. Petitioner has not denied that, as of the date of
the resurvey, it was not complying with these elements. Therefore,
HCFA afforded Petitioner the opportunity to submit to HCFA a plan
of correction showing how it would correct the additional
deficiency. That plan was submitted on October 25, 1993, and HCFA
accepted the plan. Thus, HCFA certified Petitioner to participate
in Medicare effective October 25, 1993. That date was appropriate,
in light of HCFA's previous finding of a condition-level deficiency
and in light of the unchallenged findings made by the surveyors at
the September 24, 1993 resurvey of Petitioner.
IV. Conclusion
I conclude that HCFA correctly determined that, as of May 24 - 25,
1993, Petitioner was not complying with a condition of
participation in the Medicare program.
________________________
Steven T. Kessel
Administrative Law Judge
1. As I discuss below, at Part III.A, a failure to comply
with a standard or an element of participation may be so egregious
as to comprise a failure to comply with the condition of
participation of which the standard or element is a subpart.
2. The regulations governing survey, certification, and
enforcement procedures were revised, effective July 1995. 59 Fed.
Reg. 56116, 56237 (1994). My citations to regulations in this
decision are to regulations which were in effect prior to July
1995, inasmuch as the actions at issue occurred prior to that date.
However, the revised regulations would not appear to direct a
different outcome.
3. The parties made prehearing motions for disposition of
this case. On February 28, 1995, I denied those motions and ruled
that disputed issues of material fact existed which needed to be
heard. My ruling is contained in the transcript of oral argument
of those motions, which I cite to as "Tr. of oral argument and
ruling, February 28, 1995, at (page)."
The transcript of the hearing which I conducted on September 26 -
27, 1995 is a separate document. I cite to that transcript as "Tr.
at (page)."
4. Petitioner does not argue that HCFA would have been
obligated to afford Petitioner the opportunity to submit a plan of
correction to HCFA, if HCFA determined correctly that Petitioner
was failing to comply with a condition of participation as of the
May 24 - 25, 1993 survey.
5. In the revised regulations which became effective in
July 1995, this identical language is contained at 42 C.F.R.
488.24(b). 59 Fed. Reg. 56237 (1994).
6. In its prehearing motion for disposition, Petitioner
argued that HCFA's finding of a condition-level deficiency was
insufficient because the notice of that finding which HCFA sent to
Petitioner did not specifically recite that Petitioner manifested
a deficiency which substantially limited Petitioner's capacity to
provide care or which adversely affected the health and safety of
patients, as described in 42 C.F.R. 488.24(a). I did not agree
with this argument. I concluded that a finding of a
condition-level deficiency by HCFA incorporated the definition of
a condition-level deficiency stated in the regulation. Tr. of oral
argument and rulings Feb. 28, 1995, at 12. Petitioner has not
restated this argument again in its posthearing briefs. I conclude
that there is no need for me to address it again in detail.
7. The transcript refers to Mr. Woffard, inaccurately, as
Mr. "Wofford."