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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Mt. Laurel Convalescent Center, |
DATE: December 6, 2001 |
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Centers for Medicare & Medicaid
Services
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Docket No.C-99-790
Decision No. CR841 |
| DECISION | |
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DECISION Petitioner, Mt. Laurel Convalescent Center (Petitioner
or facility), is a nursing facility 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 May 5 through May 16, 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 May 5 through May 16, 1999, the facility was not in substantial
compliance with program participation requirements, and that its conditions
posed immediate jeopardy to resident health and safety. Petitioner also
challenges the amount of the civil money penalty (CMP) imposed by CMS.
Inasmuch as CMS imposed the statutory minimum amount for facilities whose
conditions pose immediate jeopardy, the amount of the CMP must also be
sustained. BACKGROUND On October 27, 1998, Resident #1, an 85-year-old man with
a significant cardiac history, died after a short stay at the facility.
The facility did not report his death to the New Jersey Department of
Health and Senior Services (State Agency), although it terminated the
employment of Norma Mamoril, the charge nurse who was primarily responsible
for the resident's care on the night of his death. CMS Ex. 11. Months
later, the resident's family complained to the State Agency, requesting
an investigation into the circumstances surrounding his death. CMS Ex.
15. Responding to that complaint, the State Agency conducted a complaint
investigation survey of the facility on May 5, 1999. Following the survey,
the State Agency cited three areas of deficiency: Staff Treatment of Residents,
42 C.F.R. § 483.13(c)(1)(ii) (Tag F225); Resident Assessment, 42 C.F.R.
§§ 483.20(b)(4)(iv) , 483.20(d)(3)(i) (Tags F274 and F281); and Quality
of Care, 42 C.F.R. § 483.25 (Tag F309.) CMS Ex. 2. In a letter dated May 7, 1999, the State Agency advised
Petitioner that it was not in compliance with federal requirements and
that its conditions constituted immediate jeopardy to resident health
and safety. Among other remedies-termination and denial of payment for
new admissions (DPNA)-the State Agency recommended that CMS impose a CMP
of $3,050 per day until the immediate jeopardy was removed, or the facility
provider agreement terminated, whichever came first. CMS Ex. 1; Joint
Status Report, Stipulation 8. By letter dated May 10, 1999, CMS advised
the facility that it agreed that the facility was not in compliance with
federal requirements for participation in the Medicare and Medicaid programs,
and that its conditions constituted immediate jeopardy to resident health
and safety. CMS also concurred with the State Agency recommendation and
imposed a CMP of $3,050 per day. CMS Ex. 4; Joint Status Report Stipulation
8. The facility responded with a letter dated May 13, 1999,
and a plan of correction. CMS Exs. 5, 6. The State Agency then conducted
an unannounced follow-up survey on May 17, 1999, and, by letter dated
May 19, 1999, advised the facility that it had achieved and maintained
substantial compliance. CMS Ex. 7. In a letter dated June 24, 1999, CMS notified Petitioner that it would impose a CMP in the amount of $3,050 per day from May 5, 1999, through May 16, 1999, for the 12 days it determined the facility conditions constituted immediate jeopardy to resident health and safety (a total of $36,600), and that the facility was barred from conducting its own Nurse Aide Training and Competency Evaluation program for a period of two years. CMS Ex. 9; Joint Status Report Stipulation 9. Petitioner timely requested a hearing to challenge CMS' determination. In their Joint Status Report, the parties indicated that some or all of the factual disputes could be resolved through review of the documentary evidence. Therefore, in an order dated March 28, 2001, I set a briefing schedule. Among other matters, that order directed the parties to submit objections, request an in-person hearing, or (for Petitioner) ask leave to file a surreply by August 27, 2001. In a letter dated August 27, 2001, Petitioner asked leave to file a surreply, "to address the validity of the new evidence [CMS] has brought forth and its impact, if any, upon the alleged findings of noncompliance. Upon the filing of the Surreply, the record before this court shall then be complete so that the Court may make a final decision in this matter without having to resort to an in-person hearing." Petitioner's Objections at 3.(2) Petitioner filed its surreply on October 12, 2001. Petitioner's Exhibits 1 through 15 are admitted. CMS'
Exhibits 1 through 23 are admitted. The parties have fully briefed the issues, and generally
agree that these matters may be resolved on the written submissions, and
Petitioner has waived its right to an in-person hearing. ISSUES
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 attain or maintain the highest practicable physical,
mental, and psychological 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. 42 C.F.R. § 483.20(b)(4)(iv).(4) 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. The facility must not employ individuals who have been
found guilty of abusing, neglecting, or mistreating residents by a court
of law, or have had a finding entered into the State nurse aide registry
concerning abuse, neglect, mistreatment of residents or misappropriation
of their property. The facility must report, to the State nurse aide registry
or licensing authorities, any knowledge it has of actions by a court of
law against an employee which would indicate unfitness for service as
a nurse aide or other facility staff. 42 C.F.R. § 483.13(c). The facility must also ensure that all alleged violations
involving mistreatment, neglect, or abuse, including injuries of unknown
source and misappropriation of resident property are reported immediately
to the administrator of the facility and to other officials in accordance
with State law through established procedures, including to the State
survey and certification agency. The facility must have evidence that
all alleged violations are thoroughly investigated, and must prevent further
potential abuse while the investigation is in progress. The results of
all investigations must be reported to the administrator or his designated
representative, and to other officials in accordance with State law, including
to the State survey and certification agency, within five working days
of the incident, and, if the alleged violation is verified, appropriate
corrective action must be taken. 42 C.F.R. § 483.13(c). REMEDIES 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. 42 C.F.R. § 488.430(a). In situations where the deficiencies do not constitute
immediate jeopardy, but have caused actual harm or have the potential
for 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. 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) 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). 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. BURDEN OF PROOF In Hillman Rehabilitation Center, DAB No. 1611
(1997); aff'd, Hillman Rehabilitation Center v. HHS, No.
98-3789 (D.N.J. May 13, 1999), the Board set forth in considerable detail
the appropriate allocation of the burden of proof in these cases. Initially,
CMS must set forth the basis for its determination with sufficient specificity
for the provider to respond. The provider, in turn, must identify which
of the findings are material to the determination it disputes, and must
also identify any additional facts that it is asserting. At hearing, CMS has the initial burden of coming forward
with sufficient evidence to establish a prima facie case that it had a
legally sufficient basis for termination, and the Petitioner has the burden
of coming forward with evidence sufficient to establish the elements of
any affirmative arguments or defenses. Petitioner bears the ultimate burden
of persuasion. To prevail, Petitioner must prove by a preponderance of
the evidence on the record as a whole that it was in substantial compliance
with the relevant statutory and regulatory provisions. Id. at 8.
In Cross Creek Health Care Center, DAB No. 1665 (1998), and South
Valley Health Care Center, DAB No. 1691 (1999), the Board confirmed
that the Hillman standards apply to CMP determinations as well
as termination cases. DISCUSSION In reviewing CMS's determinations, 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 ("Findings") to support my decision in this case. I set forth each finding below, in italics, and as a separately numbered heading. I discuss each finding in detail.
Resident #1 was admitted to the facility on October 19,
1998, for rehabilitation. He was 85 years old, and had a history of cardiac
complications, coronary artery disease, hypertension, and peripheral vascular
disease, as well as chronic renal insufficiency. P. Ex. 12. According
to his transfer summary, at the time of admission he required 24-hour-care,
assistance with activities of daily living, and therapy for ambulation.
He was alert, but forgetful and confused. P. Ex. 12 at 7-8.
On the other hand, prior to his most recent hospitalization,
Resident #1 was living independently, and his care plan indicated a probable
length of stay in the facility of 1-3 months, with discharge to his home
and return to independent living. P. Ex. 12 at 11, 94. Until the evening
of October 27, his stay was uneventful, and he appears to have been making
progress with physical therapy. See P. Ex. 12 at 25. Except for
developing a skin rash (an allergic reaction to medication), and a problem
with the bottom of his foot, he had no complaints of pain or discomfort
and no shortness of breath. He consistently ate well. See, e.g.,
P. Ex. 12 at 25, 31-32 ("No complaints of pain or shortness of breath
at the present time"), ("Denies pain or discomfort"), ("Resps. not labored-Denies
any pain or discomfort"), ("no distress noted"), ("Appetite good"). In
fact, on October 27, 1998, nursing notes indicate that his respiration
was easy and unlabored. He had no shortness of breath or cough, and he
ate 75percent of his noon meal. P. Ex. 12 at 34. As late as 3:15 P.M.
that afternoon, he was up in the hallway, with no shortness of breath
and respiration unlabored. Id. On that same day, one of his physicians
also noted that he had no complaints of pain or shortness of breath, and
that he required a family meeting and home evaluation, presumably for
purposes of preparing a plan for discharge. P. Ex. 12 at 25. At 9:20 P.M. on the night of October 27, 1998, a nurse
declared Resident #1 dead. No effort was made to resuscitate him. Resident
#1 did not have advance directives. P. Ex. 12 at 87. Petitioner characterizes as "erroneous" CMS' conclusion
that Resident #1 experienced a significant and critical change. According
to Petitioner, the charge nurse "determined that there was not a critical
change in the Resident's condition at 6:00 P.M." In the next sentence,
Petitioner states: "At 9:20 P.M., the supervisor pronounced the resident
dead." P. Brief at 7. See also P. Surreply. I do not know
how an individual moves from basically stable to dead without undergoing
a significant and critical change in his condition, and I find puzzling
the suggestion that such change did not occur. In this regard CMS has
certainly satisfied its burden of establishing a prima facie case, and
Petitioner has not advanced evidence to refute CMS' contentions. I therefore
conclude that the uncontroverted evidence establishes a rapid and serious
deterioration in Resident #1's condition. I next consider whether the facility provided Resident #1 necessary care and services so that he could "attain or maintain the highest practicable physical, mental, and psychosocial well-being."
The record presents minimal reliable evidence explaining
what happened between 3:15 and 9:20 P.M.(5)
According to a handwritten statement from CNA Lisa Stephens, she worked
a double shift in Resident #1's unit on October 27, 1998. Dinner is served
at the facility at 5:30 P.M. Before dinner, Resident #1 was not feeling
well, and the wife of Resident #1's roommate asked the nurse to see what
was wrong. The nurse [Nurse Mamoril was charge nurse that night] instructed
CNA Stephens to put Resident #1 to bed. When CNA Stephens brought Resident
#1 his dinner tray at 5:30 P.M., he said he was not hungry and "he wasn't
feeling well enough to eat." She left the tray for him, and when she returned
at around 6:15 P.M., he had not eaten. She was back in the room at about
6:30 P.M. to assist Resident #1's roommate, but does not mention any contact
with Resident #1 at that time. She went to lunch at 7:00 P.M., worked
in other rooms, and the nurse later told her that Resident #1 was dead.
CMS Ex. 14 at 1. I note that this is the only statement in the record from
anyone who had contact with Resident #1 between 3:15 and 9:20 P.M. I find
it reliable so far as it goes. That is, Resident #1 became ill, his roommate's
wife asked the nurse "to see what was wrong," and the nurse instructed
CNA Stephens to put him to bed. It appears that CNA Stephens was the only
one who did anything for Resident #1, and all she did was put him to bed,
bring him a meal, which he did not eat, and then remove the meal tray. In a handwritten statement dated October 28, 1998, Alma
Hillwig, whose position is not identified, reports that on Tuesday, October
27, 1999, at an unspecified time, she was at the nurses' station when
an elderly white female (Mrs. P) approached and said that Resident #1
was having pain. Resident #1's nurse [Nurse Mamoril] had gone to get a
soda, so Ms. Hillwig checked to see what had been ordered for Resident
#1's pain. She saw that no pain medications had been ordered. Resident
#1's nurse subsequently returned, called the doctor, and went down the
hall toward room 105. Without explaining the basis for her belief, Ms.
Hillwig writes "I believe she assessed the [resident]." CMS Ex. 14 at
2. But Ms. Hillwig is not able even to say definitively that
the nurse entered Resident #1's room, only that she went down the hall
"toward the room." I do not consider this reliable evidence that Nurse
Mamoril provided an adequate assessment. Petitioner acknowledges that the facility did not provide
any specific treatment for Petitioner's deteriorating condition, but asserts
that its response was appropriate because "his complaints were reported
to the charge nurse who promptly went to the Resident's room to assess
the Resident and timely thereafter placed a telephone call to the Resident's
physician to obtain an order for pain medication and ensured that the
Resident was made comfortable." P. Brief at 4. The record does not support
this scenario. No reliable evidence establishes that any nurse or other
health professional assessed the resident's condition at any time over
the course of the evening until pronouncing him dead at 9:20 P.M. The
charge nurse wrote no treatment notes, and Resident #1's medical records
contain no evidence of an assessment. No blood pressure, temperature,
pulse or respiration are recorded. His medical record contains no contemporaneous
description of his condition written by anyone who had actual contact
with him. Instead, Petitioner relies on remote hearsay and speculation
to argue that the nurse performed some unspecified assessment. I do not
consider this reliable evidence. The only supported assertion Petitioner makes is that
Resident #1's complaints were reported to the charge nurse. CNA Stephen's
statement indicates that Nurse Mamoril sent her to put Resident #1 to
bed, but does not suggest that the nurse ever entered the room (although
the surveyor notes suggest that she probably did). Further, according
to the Hillwig statement, Nurse Mamoril called the physician before
she went down the hall toward Resident #1's room. Having not been to the
resident's room, Nurse Mamoril was not in a position to advise Resident
#1's physician of his condition. I note also that nothing in the record
suggests that she conveyed to his physician's office anything more than
a request for pain medication. See Pettinelli Certification at
2 ¶ 6, 7. Moreover, notwithstanding Petitioner's current assertions
as to the appropriateness of the care Nurse Mamoril provided, in a letter
dated December 28, 1998, Petitioner's Administrator, Florence Werlinsky,
advised the New Jersey Board of Nursing that it asked for Nurse Mamoril's
resignation for violating, on October 27, 1998, the facility policy and
procedure regarding notifying the physician of a change in the resident's
condition. The letter goes on to say:
(emphasis added) CMS Ex. 11. These are very harsh charges
to level against a professional, and presumably would not have been lightly
made. Petitioner has not explained the discrepancy between the contents
of this letter and its current position.(7) Based on the above evidence, which is the only evidence
in this record that I consider reliable, I conclude that CMS has met its
burden of setting forth a prima facie case of resident neglect, and the
Petitioner has not met its burden of establishing by a preponderance of
the evidence that it was in substantial compliance with federal requirements
for staff treatment of residents, resident assessment, and quality of
care. In reaching this conclusion, I emphasize that I do not
hold Petitioner to a strict liability standard. Petitioner correctly points
out that Resident #1 was elderly and infirm. He had a cardiac condition.
On the other hand, a vulnerable patient requires greater monitoring and
care than would a younger, more vigorous patient. Petitioner's evidence
simply does not establish that the facility provided Resident #1 with
that monitoring and care. I now discuss why I do not consider that Petitioner's
evidence establishes substantial compliance. I note first that, according
to Administrator Werlinsky's Certification, she assigned to the facility's
Director of Staff Development, Ms Jackie Nicholson, the responsibility
of conducting a thorough investigation of the care provided to Resident
#1. Werlinsky Certification at 2 ¶ 6. Administrator Werlinsky states that
she received the report of the investigation, which included statements
from the nurses, the certified nurse aide, the supervisor, and the visitor
(presumably Mrs. P, the wife of Resident #1's roommate). The charge nurse
declined to provide a statement. Id. at 3 ¶ 9. In her certification,
Director Nicholson indicates that, in November 1998, she provided both
interim and final reports to Administrator Werlinsky. Nicholson Cert.
at 3 ¶ 10. Significantly, Petitioner did not submit as evidence copies
of either report, and did not include among its exhibits the visitor's
statement.(8) Instead, Petitioner submits
Certifications from individuals who were removed from the events of October
27, but who reach general conclusions based on conversations and/or their
review of documents. In critical instances, the witness does not identify
with any degree of particularity the source of his/her assertion. Characteristic of this approach is the certification provided
by Ms. Gail Amor Rader, a consultant hired by the facility. Consultant
Rader echoes Petitioner's assertion that the charge nurse responded appropriately
to reports of Resident #1's complaints of pain by going to the resident's
bedside, assessing the resident's complaint, determining no significant
change in the resident's status, and telephoning the resident's physician
to obtain an order for pain medication, "in keeping with the standard
of practice for nursing." Rader Certification at 6 para. 19. The problem
with Consultant Rader's conclusion, of course, is that its factual underpinning
is inconsistent with the reliable evidence in the record, as discussed
above. And, Consultant Rader does not disclose the specific sources of
her information, but only alludes generally to her conclusions being "based
on my audit." Id. Consultant Rader later asserts that the resident was monitored
throughout the evening by various staff members, including a certified
nurse assistant, the charge nurse, and the supervisor. Id. at 7
¶ 24. Again, she cites no specific source except "based on my audit" which,
she says, included review of Resident #1's medical record. The total of
Resident #1's "medical record" for the evening of October 27, 1998 consists
of a cryptic note in the nursing notes written by the Nurse Supervisor,
Catherine Sharkey, after the resident's death.(9)
The note suggests that between 3:15 P.M. and 9:20 P.M. staff provided
minimal care. The note says that he was assisted to the bathroom, and
that he complained of leg pain, an assertion that is not wholly supported
by the statements from CNA Stephens and Ms. Hillwig, who refer only to
complaints of pain, not specifically to leg pain. The note then says that
the MD was called for pain medication, that the resident refused dinner
but drank some fluids (a fact not mentioned in the Stephens' affidavit),
that he asked to be put to bed, and that he ate no dinner. At 9:20 P.M.
Supervisor Sharkey was called into the resident's room and found him unresponsive.
P. Ex. 12 at 34. This entry simply does not support the assertion that
Resident #1 was "monitored" by staff "throughout the evening." Moreover, Supervisor Sharkey's assertions suffer the same
deficiencies as Consultant Rader's. They are based on unattributed hearsay.
Supervisor Sharkey admits she provided no care to Resident #1. She did
not observe him between 3:15 and 9:20 P.M. She did not observe care being
provided to him. Her statement does not suggest that she had any knowledge
of Resident #1 until sometime after 9:00 P.M. when she observed the charge
nurse leave his room. Curiously, the time of her note is set at 9:00 to
9:10 P.M., although its contents indicate that he had expired "at this
time 9:20 P.M." CMS Ex. 12. An expert opinion has value only to the extent that the
expert can support it. Consultant Rader has not supported her opinions
with any verifiable facts. I therefore reject her opinion. For the same reasons, I reject the unsupported opinions
offered in Petitioner's other certifications. For example, Assistant Director
of Nursing, Karen Thomas, was on vacation on October 27, and did not return
to the facility until November 7, 1998.(10)
Her claims of knowledge are at least as remote as Consultant Rader's:
participation in numerous meetings at the facility "which included the
topic of the care provided to Resident #1 the evening of October 27, 1998,"
"review of the care provided," "results of the investigation conducted,"
"review of the medical records," and "review of the investigative materials."
Thomas Certification at 3 ¶ 9, 5 ¶ 12, 7 ¶ 18. Thus, the conclusions contained in these and the certifications
from Petitioner's other witnesses lack foundation. They are inconsistent
with the facility's earlier statement and actions regarding Nurse Mamoril.
In addition, they are simply inconsistent with professionally recognized
standards of care. The broad requirements of 42 C.F.R. § 483.25 implicitly
include a requirement that the facility adhere to professionally recognized
standards of care in providing care and treatment to its residents. Lake
City, at 5. Under professionally recognized standards, assessments
and clinical notes must be written by the individual who administers the
care. See P. Ex. 21 ("having someone else chart for you can be
punishable/anything from a reprimand to actual suspension of your nursing
license.") Assessments must contain certain minimal information. For example,
in assessing pain, the provider should determine when it began, its location,
intensity (using an objective scale), quality, alleviating or aggravating
factors, and affect on quality of life. See CMS Exs. 20, 22, 23. In their
declarations, CMS's witnesses set forth acceptable practice with respect
to performing assessments, and charting clinical notes. Drake-Van Orden
Declaration, Johnson Declaration. Although Petitioner's witnesses assert
generally that its practices met professional standards, at least "at
a minimal level," (See Werlinsky Certification), not one of Petitioner's
witnesses specifically challenges those particular statements. I consider the facility's failure to assess and provide care to Resident #1 between 3:15 and 9:20 P.M. on the night of October 27, 1998, by itself, sufficient to justify a finding of substantial noncompliance.
CMS also cites deficiencies under 42 C.F.R. § 483.25 (Quality
of Care), 42 C.F.R. § 483.20 (Resident Assessment), and 42 C.F.R. § 483.13
(Staff Treatment of Residents) based on the staff's inaction after finding
Resident #1 unresponsive in his bed sometime after 9:00 P.M. Again, the
evidence in the record is minimal-a short entry in the clinical record
and Nurse Sharkey's statement. The clinical note, written by Nurse Sharkey
says that the charge nurse called her away from the nurses' station at
9:20 P.M. Resident #1 was in bed, lying on his right side, unresponsive
to name, negative respiration, negative carotid pulse, negative peripheral
pulse on examination, negative heart rate present. The note suggests that
staff took no further action except to call the physician to report the
death. P. Ex. 12 at 34. Nurse Sharkey's statement provides few additional details. It states that the charge nurse came out of Room 105 -
(emphasis in original) CMS Ex. 12. Thus the evidence suggests - although it does not establish
definitively - that the charge nurse went into Resident #1's room, and
some time after, left the room and summoned the supervisor. The record
is silent as to how long Nurse Mamoril was in the room, and what, if anything,
she did before she left and summoned the supervisor. We do not know how
long Resident #1 had been unresponsive before Nurse Mamoril found him,
nor when he was last observed in a more responsive condition. The record
establishes that staff made no effort to treat him, but apparently pronounced
him dead, although neither the clinical record nor Nurse Sharkey's statement
explicitly says that the formal pronouncement was made. Nor does the record
establish whether the staff knew that Resident #1 was "full code." In
the certifications, Petitioner's witnesses aver generally that staff were
aware of his full code status. But, the record contains no statement from
either of the two individuals who made the decision not to initiate CPR
that they were aware of his status. In her written statement, Nurse Sharkey
does not mention any knowledge of the resident's full code status, which
suggests that she may not have been aware of it. Based on the minimal evidence in the record, I do not
see how anyone can possibly know whether staff should appropriately have
initiated resuscitation efforts at 9:20 P.M. However, CMS has demonstrated
that Resident #1 had a fatal heart attack (CMS Ex. 18), and that he was
"full code," which means that if his heart or respiration stopped, his
instructions were that efforts be made to resuscitate him. P. Ex. 12 at
87. No efforts were made to resuscitate him. This meets the prima facie
standard. Petitioner presents certifications asserting that, because the supervisor pronounced him dead, the nurses were not required to attempt to resuscitate, but Nurse Sharkey's statements leave many critical questions unanswered, and, again, Petitioner has not submitted evidence from Nurse Mamoril, the individual in a position to answer those critical questions surrounding Resident #1's death.(12) Therefore, Petitioner has not met its burden of establishing substantial compliance.
That the facility failed to provide Resident #1 with the
"necessary care and services" so that he could "attain or maintain the
highest practicable physical, mental, and psychosocial well-being" is
amply demonstrated by the record in this case. Petitioner points out,
however, that by May 5, 1999, the time of the survey, Nurse Mamoril was
no longer employed by the facility, and, as of 9:20 P.M. October 27, "Resident
#1's care issues ceased to exist." P. Brief at 67. According to Petitioner,
since the deficiencies cited were isolated, revolving around the care
(or lack of care) provided to one resident over a three hour period more
than six months prior to the date of the survey, CMS should not have found
noncompliance at the time of the survey, and should not have imposed a
CMP over a period of 12 subsequent days. P. Brief at 2. With respect to the "isolated" nature of the deficiencies,
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, DAB No. 1658 at
14. Since I have found that the incident in question had the potential
for more than minimal harm, I must also find that the facility was out
of substantial 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 supplied) Id.
at 14-15. Further, 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, DAB No. 1658 at 15. I agree that the time lag between the incident and the complaint investigation was unfortunately long. However, as discussed above, Petitioner did not report to the State Agency the circumstances surrounding Resident #1's death, even though Resident #1's family complained to the facility on October 28, 1998, immediately after the death, and the facility purportedly launched an investigation. Way Certification at 3 ¶ 7.(13) Since it did not advise the State Agency of a potential
problem, the facility can hardly hold the State Agency responsible for
delay in conducting the complaint investigation. Moreover, the facility has not demonstrated that, at the
time of the survey, it had "implemented a plan of correction designed
to assure that no such incidents occur in the future." The facility has
not demonstrated that it conducted a thorough investigation. It has not
produced copies of the interim and final investigative reports. More troubling,
the investigation purportedly "did not yield concerns regarding Facility
policies and procedures or the existing systems established to ensure
substantial regulatory compliance and prevention of any potential resident
neglect." P. Brief at 45 (citing Werlinsky Certification). Such conclusion
gives lie to the claim that the facility had implemented a plan designed
to assure that no such incidents occurred in the future. Petitioner points out that both Nurse Mamoril and Nurse
Sharkey were long-time employees with good work records. Nurse Mamoril
"continually met the criteria to fulfill the role of charge nurse." She
"was qualified to provide care; she was licensed; passed competency tests
and was appropriately in-serviced on applicable policies." P. Brief at
67 citing Werlinsky Certification. At the time of the incident, the facility
may well (as it claims) have had in place adequate written policies and
procedures designed to prevent neglect. The facility may also have provided
staff training, and evaluation. Nevertheless, two of its long-standing
employees with good work records committed serious errors, and, by the
time of the May 5 survey, the facility had not demonstrated what went
wrong nor how. 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. Fairfax Nursing Home, Inc., DAB No. 1794 at
19 (2001). 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 May 5 survey.
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, DAB No. 1658 at 17. Petitioner suggests that CMS must prove a causal connection
between the deficiency and Resident #1's death. Resident #1 was elderly.
He had a significant cardiac condition. At this point it is impossible
to know whether appropriate assessment and care could have prevented his
death, although a reasonable case can be made that the facility's failure
to treat a cardiac patient complaining of significant pain necessarily
causes actual harm, even if intervention would not ultimately save a life.
At a minimum, some intervention might alleviate pain and allow for family
or other contact during the person's final hours. And I do conclude that
the facility's failure here caused actual harm. Moreover, the regulations
do not require any finding of actual harm to justify a determination that
immediate jeopardy to residents exists. Southridge Nursing and Rehabilitation
Center, DAB No. 1778 (2001); Woodstock Care Center, DAB No.
1726 at 9 (2000). The standard is whether the deficiency "has caused or
is likely to cause harm." Fairfax, DAB No. 1794 at 13-14. A facility's failure to assess a resident experiencing
a sudden onset of significant symptoms, along with its failure to provide
appropriate care, is likely to cause serious harm or death to a resident.
Indeed, such deficiency fits exactly within the examples of immediate
jeopardy cited in the State Operations Manual: "failure by staff to respond
to changes in physiologically monitored status." See SOM, Appendix
Q at Q-10, cited in Lake City, DAB at 19. For these reasons, I
conclude that the facility's level of noncompliance posed immediate jeopardy
to resident health and safety. Because the statute requires imposition of penalties in
the range of $3,050 to $10,000 per day for deficiencies constituting immediate
jeopardy, the amount of the penalty imposed here, $3,050 per day, must
be sustained. 42 C.F.R. § 488.438. CONCLUSION For all of the reasons discussed above, I uphold CMS's determinations that from May 5 through May 16, 1999, the facility was not in substantial compliance with the program participation requirements for Staff Treatment of Residents, Resident Assessment, and Quality of Care. The facility's deficiencies posed immediate jeopardy to resident health and safety, and the statute mandates imposition of a civil money penalty at least equal to the amount of the CMP imposed - $3,050 per day ($36,600 total). |
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| JUDGE | |
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Carolyn Cozad Hughes Administrative Law Judge
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| FOOTNOTES | |
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1. The Health Care Financing Administration has been renamed the Centers for Medicare and Medicaid Services (CMS). 2. Petitioner also argues that CMS' submission of additional exhibits violated Judge Clifton's February 8, 2000 order. In fact, Judge Clifton's order does not specifically preclude later submission of additional evidence. Rather, it seems to anticipate that the parties will supplement additional documents following the initial exchange. ("The parties are expected to coordinate with each other any supplementation or follow-up prompted by the initial exchanges.") The parties acknowledge in their Joint Status Report that they may submit additional documents ("Both parties reserve the right to further exchange, as necessary.") Joint Status Report at 5. In any event, Petitioner indicated that upon its filing a surreply, "all factual and legal issues would be adequately addressed by the parties and the record will be complete such that this Court will be able to make a final determination in this matter on the papers. No in-person hearing is necessary." Petitioner's August 27, 2001 Submission at 4. 3. The parties agree that the bar on Nurse Aide Training and Competency Evaluation is not reviewable here, although the regulation was subsequently amended to allow such review. See CMS Brief at 7, n.1, Joint Status Report at 4-5 (Feb. 5, 2001). 4. The resident assessment regulation has been amended several times since the incident in question. 62 Fed. Reg. 67211 (December 23, 1997); 63 Fed. Reg. 53307 (October 5, 1998); 64 Fed. Reg. 41543 (July 30, 1999). However, the cited provision was in effect on October 27, 1998, and the parties do not dispute its contents or applicability to this case.
5. Petitioner's witnesses declare that the facility conducted interim and final internal investigations of the circumstances surrounding Resident #1's death. Rader Certification; Werlinsky Certification; Nicholson Certification. However, Petitioner did not submit those investigative reports as evidence. 6. In fact, Nurse Mamoril's resignation letter is dated 11/2/98. P. Ex. 13. 7. Furthermore, the letter's assertion that she admitted the neglect suggests that the facility gathered additional evidence from Nurse Mamoril which it has not provided. 8. Both parties cite the surveyor notes, CMS Ex. 3, which refer to the surveyor's review of documents that are not in the record. Although the notes are far more specific than any of the certifications, the facts contained therein are also remote hearsay. Based generally on the surveyor's review of the written statements of others, these notes are certainly not as reliable as the documents referred to, which should be in the facility's control and possession, but which the facility did not submit. Accepting as true the facts contained in the notes, at dinner time, the visitor observed Resident #1 in distress. The visitor "went and got the nurse." Half an hour later, Resident #1 started to moan loudly, and the visitor again informed staff. The RN visited, and asked Resident #1 if he had pain. He first said "no," but then said "My whole body hurts." If accepted, the notes do not establish that an appropriate assessment or treatment were provided. In fact, they show the sudden onset of severe symptoms with no suggestion of an appropriate response. 9. According to the surveyor notes, Nurse Sharkey "doesn't remember anything." P. Ex. 15. 10. In a small discrepancy, Dr. Pettinelli asserts that he discussed Resident #1's care on the night of October 27 with ADON Thomas "during the month of October 1998." ADON Thomas did not return to the facility until November 7. 11. Again, the entry time indicated is 9:00 to 9:10 P.M.. 12. In his certification, Dr. Pettinelli suggests that Resident #1 could have been dead for as long as an hour and still felt "warm to the touch." I do not see how this furthers Petitioner's case. The longer Resident #1 lay dead without anyone's noticing, the stronger CMS' case that staff neglected him. 13. Petitioner claims that it was not required to report to the State Agency because its investigation yielded no finding of neglect. P. Brief at 28. The facility's finding that no neglect occurred is, of course, problematic. Moreover, the regulations require reporting "all alleged violations" and the results of investigations "within 5 working days of the incident." 42 C.F.R. § 483.13(c). | |