Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Crestview Parke Care Center, |
DATE: February 4, 2002 |
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Centers for Medicare & Medicaid
Services
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Docket No.C-00-204
Decision No. CR867 |
DECISION | |
DECISION Petitioner, Crestview Parke Care Center (Petitioner or
Facility), is a long term care facility certified to participate in the
Medicare and Medicaid programs as a provider of services. Petitioner challenges
the Centers for Medicare & Medicaid Services' (CMS's) determination
that, from August 13 until October 21, 1999, it was not in substantial
compliance with program participation requirements. For the reasons set
forth below, I conclude that, from August 13 until October 21, 1999, the
facility was not in substantial compliance. Petitioner also challenges
the amount of the Civil Money Penalty (CMP) imposed, $400 per day. I conclude
that the amount of the CMP is reasonable. I. Background
As a condition for participation in the Medicare and Medicaid
programs, skilled nursing facilities (SNFs) (Medicare) and nursing facilities
(NFs) (Medicaid) periodically undergo surveys to determine whether they
are in substantial compliance with program requirements, and the Secretary
of the Department of Health and Human Services contracts with state survey
agencies to conduct those surveys. Social Security Act (Act), section
1864(a); 42 C.F.R. � 488.20. The regulations require that each facility
be surveyed at least once every 12 months, and more often, if necessary,
to ensure that identified deficiencies are corrected. 42 C.F.R. � 488.20(a). In this case, on August 12, 1999, the Ohio Department
of Health (hereafter, "State Agency") completed a Life Safety Code (LSC)
survey of the facility, and concluded that it did not satisfy LSC requirements
for emergency lighting. LSC �� 5-102, 10-1293, 10-1294, 10-2272 (incorporated
by reference in 42 C.F.R. � 483.70(a)). CMS Ex. 2. On the following day,
the State Agency completed a standard compliance survey, finding that
the facility did not meet requirements for Environment (42 C.F.R. � 483.15),
Quality of Care (42 C.F.R. � 483.25), Dietary Services (42 C.F.R. � 483.35),
and Administration (42 C.F.R. � 483.75). CMS Ex. 3. In a letter dated August 30, 1999, the State Agency advised
Petitioner that it was not in compliance with federal requirements for
nursing homes participating in the Medicare and Medicaid programs. In
addition to the remedies of termination and denial of payment for new
admissions (DPNA), the State Agency recommended that CMS impose a civil
money penalty of $400 per day, effective August 13, 1999. The State Agency
also advised that if, prior to October 2, 1999, the facility alleged compliance,
the State Agency would accept that allegation and would not recommend
imposition of the proposed remedies unless it subsequently determined
by follow-up survey that the substantial noncompliance continued. CMS
Ex. 1. Thereafter, the facility submitted a plan of correction,
alleging substantial compliance as of October 1, 1999. On October 5, 1999,
the State Agency conducted a follow-up survey to verify compliance, but
determined that the facility still did not meet requirements for Environment
(42 C.F.R. � 483.15). CMS Ex. 6. By letter dated October 8, 1999, the
State Agency advised the facility that, because of the deficiencies found
during the August 13, 1999 survey and the follow-up survey of October
5, it recommended that CMS 1) impose the DPNA; 2) impose a CMP of $400
per day from August 13, 1999, until the facility achieved substantial
compliance or its provider agreement terminated; and 3) terminate the
facility's provider agreement. CMS Ex. 4. By letter dated November 1, 1999, CMS advised the facility
that it agreed that the facility was not in substantial compliance with
federal requirements for participation in the Medicare and Medicaid programs;
that, at the time of the August 13, 1999 survey, the facility's most serious
deficiencies constituted actual harm that was not immediate jeopardy;
and that, at the time of the October 5, 1999 survey, its most serious
deficiencies constituted no actual harm with the potential for more than
minimal harm that was not immediate jeopardy. CMS also concurred with
the State Agency recommendations to impose a DPNA effective November 16,
1999, and to impose a CMP of $400 per day. CMS Ex.7. The State Agency subsequently conducted a second follow-up survey on October 21, 1999, and, by letter dated November 2, 1999, advised the facility that it had achieved substantial compliance as of October 21. CMS Ex. 8. By letter dated November 19, 1999, CMS advised Petitioner that neither the DPNA, nor termination would be imposed, and the CMP of $400 per day was discontinued as of October 21, 1999, the day the facility achieved substantial compliance. The CMP was thus imposed for 69 days, and totaled $27,600.00. CMS Ex. 10.
The facility timely appealed, and the case was assigned
to Administrative Law Judge Marc R. Hillson. At Petitioner's request,
and in the absence of objection, Judge Hillson stayed the matter to allow
the parties to pursue settlement negotiations. Apparently, settlement
efforts were not successful. Following Judge Hillson's departure from
the Civil Remedies Division, the case was re-assigned to Judge Marion
T. Silva. In June 2000, the parties filed readiness reports and, in an
order dated August 7, 2000, Judge Silva set deadlines for the parties'
initial and final exchanges of proposed exhibits, exhibit lists, witness
lists, and statements in lieu of testimony, to be completed by December
4, 2000. Thereafter, on December 6, 2000, this matter was re-assigned
to me. I directed the parties to indicate their availability for an in-person
hearing. Incredibly, the parties advised me that they would not be available
for hearing until at least September 2001, and so the case was scheduled
for hearing the week of September 18, 2001. On August 28, 2001, we notified
the parties of a prehearing telephone conference scheduled for September
10, 2001, at which they were expected to stipulate to uncontested factual
matters, to delineate the issues in controversy, to identify the evidence
and witnesses to be presented at hearing, and to voice any objections
to proposed witnesses or exhibits. See 42 C.F.R. � 498.47. At the September 10, 2001 prehearing conference, I admitted
into the record CMS Exhibits (Exs.) 1 through 48, and Petitioner's Exhibits
(P. Exs.) 1 through 6. The parties were not, however, prepared to stipulate
uncontested facts, nor to delineate with any degree of specificity the
issues in controversy. In an effort to learn the findings and conclusions
that Petitioner challenged, as well as the specific bases for its challenges,
I referred Petitioner to CMS Exs. 2 and 3, the Statements of Deficiencies
for the August 1999 surveys, and asked pointed questions about the deficiencies
cited, many of which the surveyors articulated with great specificity.(1)
However, with limited exception(2), Petitioner was unable to say whether it challenged any of the specific findings of fact contained in the survey report forms. I therefore continued the prehearing conference to the following day, directing the parties to stipulate to certain obvious facts, such as times and circumstances of surveys, the individuals present during the surveys, and, as possible, to qualifications of witnesses and other facts. I also directed that Petitioner review the survey report form for the October 1999 survey, and to be prepared to indicate whether it challenged as untrue the specific facts asserted, and to provide the specific reasons for challenging the findings. See Summary of Results of Prehearing Conference (Sept. 10, 2001). History intervened on September 11, 2001. The scheduled
telephone conference could not be held, and we were unable to convene
the scheduled in-person hearing on September 18, 2001. Instead, I scheduled
the continued prehearing conference call for September 19, 2001. However,
the parties had not complied with my September 10, 2001 instructions.
CMS had, on September 13, 2001, forwarded proposed stipulations to Petitioner,
but Petitioner had not responded. Moreover, Petitioner was still unable
(or unwilling) to disclose the specific survey findings it challenged
and the bases for those challenges. I therefore ordered the parties to
submit prehearing briefs for the purpose of delineating clearly the issues
in dispute. In a written order dated September 21, 2001, I directed the
parties to submit briefs, and to include 1) a statement of each of the
facts that the party intends to prove at hearing; 2) a discussion of the
relevant law and how it relates to the facts; 3) an explanation of how
the evidence that has been admitted into the record proves the facts that
the party alleges; and 4) an explanation of how the testimony the party
proposes to elicit from each witness proves the facts that are alleged.
I directed each party to include affidavits or declarations from its witnesses.
Summary of Results of Prehearing Conference and Order to Submit Briefing
(Sept. 21, 2001).
In objecting to cancellation of the in-person hearing, Petitioner argues that-
Petitioner's Notice of Objection to Cancellation of
Hearing (December 19, 2001). This echoes the position argued in its
brief, where Petitioner claims the "right to mandate that CMS carry its
burden of proof and persuasion under Gold Country, as well as its
right to cross-examine each of CMS' witnesses with respect to their observations
and interpretive application of the regulatory authority for which Crestview
was cited." Petitioner's Brief (hereafter, P. Brief) at 2.(6) In Gold Country, Judge Leahy set forth the evidentiary
process, articulated by the Board in Hillman Rehabilitation Center,
DAB No. 1611 (1997); aff'd, Hillman Rehabilitation Center v.
HHS, No. 98-3789 (D.N.J. May 13, 1999).(7)
However, nothing in Gold Country nor any other authority compels
an in-person hearing where material facts are not in dispute. As Judge
Leahy recognized, the evidentiary standards are separate from questions
of whether material facts are in dispute, compelling an in-person hearing.
That CMS has an initial burden does not in itself compel an in-person
hearing. Unless the parties have raised a genuine issue of material fact,
summary disposition is appropriate. Everett Rehabilitation and Medical
Center, DAB No. 1628, at 3 (1997); Carmel Convalescent Hospital,
DAB No. 1584, at 27 (1996). Thus, in Carmel Convalescent, where
the petitioner had the opportunity to present its case with briefs and
supporting documentation, but did not demonstrate a genuine dispute of
material fact, the Board affirmed summary disposition. Carmel Convalescent,
DAB No. 1584, at 22. See also Glenburn Home, DAB
No. 1806, at 17 (2002) ("[I]n reviewing a case where an ALJ failed to
either obtain a written waiver or hold an oral hearing, we may nonetheless
uphold the decision if the affected party either had conceded all of the
material facts or proffered testimonial evidence only on facts which,
even if proved, clearly would not make any substantive difference in the
result.") and Cherrywood Nursing and Living Center, DAB CR845 (2001)
("Where inferences made from facts which are averred to support a motion
must be made in a manner most favorable to the party that opposes the
motion, it is not sufficient for a party simply to state that it disputes
allegations of fact in order to avoid possible entry against it of summary
disposition. That party must describe the asserted facts credibly in order
to establish a dispute.") Thus, where facts are in dispute, a judge may, nevertheless,
issue a decision on the written record. If material facts are in dispute
(as in Glenburn Home), and the parties waive the in-person
hearing, then the judge resolves those disputes of fact based on the weight
of the evidence. This is not summary judgment. Where, as here, Petitioner
does not waive its in-person hearing, and has raised some factual disputes,
the judge determines whether those facts are material by resolving all
legitimate factual disputes in favor of the non-moving party, in this
case, Petitioner. If, after so resolving all factual disputes, CMS establishes
substantial noncompliance that justifies the penalties imposed, the disputed
facts are not material and CMS is entitled to summary judgment. Here, CMS has come forward with a detailed list of its findings(8) and has set forth its rationale for determining substantial noncompliance. Petitioner was afforded ample opportunity to show, through argument and supporting documentation, the bases for its challenges to these findings. Indeed, my September 21, 2001 order required each party to set forth the facts it intended to prove at hearing, and to explain how its evidence, the documents admitted and the declarations of its witnesses, prove the facts alleged.(9) And, as discussed in more detail below, with respect
to several critical issues, Petitioner has not raised a dispute of material
fact: namely, whether its back-up generator was in good working order
at the time of the survey; whether its documentation demonstrated that
required periodic testing of that generator had been performed; whether
specific environmental conditions existed at the facility at the time
of the surveys; whether it followed physician orders designed to protect
from skin break-down certain at-risk residents; whether its documentation
established adequate in-service training of nurses' aides. Whether these
undisputed facts amount to substantial noncompliance is a conclusion of
law, not an allegation of fact. In this regard, it is important to distinguish between
facts and conclusions. Conclusions and legal arguments do not establish
material facts in dispute. For example, Petitioner's claim that it "provided
each resident with necessary care and services to attain or maintain the
highest practicable physical, mental and psychosocial well-being, in accordance
with the comprehensive assessment and plan of care," is a conclusion.
The surveyor's observation that at 8:30, 9:15, and 11:30 A.M. on August
12, 1999, Resident #90 lacked elbow protectors or a hand splint is a fact
that Petitioner has not disputed. Similarly, that the facility maintained
a sanitary, orderly and comfortable interior is a legal conclusion. The
surveyors' findings of "brown, caked-on substances" on medication cart
drawer pulls and a big hole in the wall in Room 17 are facts; again, not
challenged by Petitioner. With respect to Petitioner's purported right to cross-examine
each of CMS' witnesses, no party has an absolute right to conduct cross-examination.
My inquiry is limited to matters at issue, and, like all other evidence,
I am directed to receive into the record only that testimony, including
cross-examination testimony, and those documents that are relevant and
material. 42 C.F.R. � 498.60(b). Moreover, with respect to denying the
ALJ the opportunity to assess credibility, witness credibility is plainly
not an issue where the facts to which those witnesses attest are not in
dispute. Having determined that Petitioner has not raised a genuine issue of material fact, I now address the merits of this case, based on the uncontroverted facts. II. Issues1. Whether, from August 13, 1999, until October 21, 1999,
the facility was in substantial compliance with program participation
requirements, specifically 42 C.F.R. � 483.15 (Environment), 42 C.F.R.
� 483.25 (Quality of Care), 42 C.F.R. � 483.35
(Dietary Services), 42 C.F.R. � 483.75 (Administration), and 42 C.F.R.
� 483.70(a) (Life Safety Code). 2. If the facility was not in substantial compliance,
is the amount of the Civil Money Penalty imposed, $400 per day from August
13 until October 21, 1999 (total of $27,600), reasonable? III. Statutory and Regulatory Background The Act sets forth requirements for nursing facility participation
in the Medicare and Medicaid programs, and authorizes the Secretary of
the Department 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 and Medicaid programs,
facilities periodically undergo surveys to determine whether they comply
with applicable statutory and regulatory requirements for Medicare (SNFs)
and/or Medicaid (NFs). They must maintain substantial compliance with
program requirements, and, 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. The facility must be designed, constructed, equipped,
and maintained to protect the health and safety of its residents, personnel,
and the public. 42 C.F.R. � 483.70. By statute and regulation, a skilled
nursing facility must meet the provisions of the Life Safety Code (LSC)
of the National Fire Protection Association, as applicable to nursing
homes, unless the Secretary determines that resident or personnel health
and safety will not be affected and waives the requirement. Act, section
1819(d)(2); 42 C.F.R. � 483.70(a). Both the 1967 and the 1981 versions
of the LSC require that the facility have the ability "automatically"
to provide emergency lighting in the event of an interruption in normal
lighting. 1981 LSC � 5-9.2.3; 1967 LSC � 5-10221. The "quality of life" regulation includes an environmental
requirement that the facility provide housekeeping and maintenance services
necessary to maintain a sanitary, orderly, and comfortable interior. 42
C.F.R. � 483.15(h)(2). The facility must also store, prepare, distribute, and
serve food under sanitary conditions. 42 C.F.R. � 483.35(h)(2). Under the statute and "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. Based on the comprehensive assessment,
the facility must ensure that a resident who enters the facility without
pressure sores does not develop them unless the individual's clinical
condition shows that they were unavoidable, and a resident having pressure
sores receives treatment and services necessary to promote healing, prevent
infection, and prevent new sores from developing. 42 C.F.R. � 483.25(c). The facility must also 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 psychological
well-being of each resident. 42 C.F.R. � 483.75. More specifically, with
respect to its nurse aides, the facility must provide regular in-service
education of no less than 12 hours per year that is sufficient to ensure
their continuing competence. Training must address areas of weakness as
determined by performance reviews, and may address special needs of residents.
42 C.F.R. � 483.75(e)(8). 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 Civil Money Penalty (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). 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. 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). The factors in section
488.404 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. Findings of Fact And Conclusions of Law(10)
As discussed above, by statute and regulation, provisions
of the Life Safety Code have been incorporated into the program participation
requirements. Act, section 1819(d)(2); 42 C.F.R. � 483.70(a). The 1967
Life Safety Code, applicable to two of the facility buildings, and the
1981 Code, applicable to the third building, both require that the facility
be able to provide emergency lighting in the event of a power failure.(11)
Emergency lighting must "be arranged as to provide the required illumination
automatically in the event of any interruption of normal lighting, such
as any failure of public utility or other outside electrical power supply,
opening of a circuit breaker or fuse, or any manual acts, including accidental
opening of a switch controlling normal lighting facilities." 1981 LSC
� 5-9.2.3; accord 1967 LSC � 5-10221. The system must "be either
continuously in operation or capable of repeated automatic operation without
manual intervention." 1981 LSC � 5-9.2.4. Surveyor Leann Slusher surveyed the facility's compliance
with the LSC. Her declaration and the survey documents set forth her specific
observations: On August 12, 1999, between 11:00 A.M. and 11:04 A.M., while
touring the building with the facility administrator, Michael Campbell,
and the Director of Maintenance, Mervon Hickson, the emergency generator
failed to start two out of two times when the test button was pushed in
the main panel in the upstairs courtyard. She then observed a facility
employee attempt, unsuccessfully, to start the emergency generator by
pushing a button on the generator itself. She reviewed the facility's
generator log, which did not show that, since January 1999, any weekly
tests had been performed on the emergency generator, nor that the emergency
generator had been run under a load monthly as required by the LSC. The
administrator and two maintenance employees verified her observation.
The facility subsequently called for repairs; a repair man came to the
facility; and at 2:07 P.M. they were able to start the emergency generator.
CMS Ex. 2 at 1-2; CMS Ex. 15 at 8, 20, 35; Slusher Declaration. Petitioner does not challenge any of these specific factual findings. With respect to the surveyor observation that the generator did not function when tested on the day of the survey, Petitioner characterizes that failure as "a serendipitous and unforeseen event which, practically speaking, would not present even a reasonable risk of minimal harm." P. Brief at 2. In her declaration, Julie Hrybiniak, Regional Administrator
for Regal Care,(12) the entity that operates
the facility, does not deny that the generator failed during the survey.
Rather, she asserts that after the survey, corporate maintenance was called,
and on "every test, both before and after the survey, the generator functioned
appropriately. Why it did not at that particular time is unknown and unexplained."
Hrybiniak Declaration at 1, para. 2. She also asserts, generally,
that the generator "does run, is tested routinely, and is documented as
such." In her second declaration she claims "per staff the generator did
function prior to survey." Second Hrybiniak Declaration at 1, para.
1. First, I find it noteworthy that Petitioner offered no
statements from the individuals who were in the best position to comment
on the surveyor finding, Facility Administrator Campbell and Director
of Maintenance Hickson.(13) More significant,
it has not produced the facility's generator log, nor any other documentation
establishing when, how often, and under what conditions the generator
was tested. In her second declaration, Regional Administrator Hrybiniak
asserts that the facility had recently changed ownership and concedes
that its new owners "did not have adequate time to implement our generator
test log." Second Hrybiniak Declaration, para. 1.(14) To say that the generator functioned appropriately on
"every test" before and after the survey says nothing about when it was
tested prior to the survey. Moreover, Regional Administrator Hrybiniak
does not directly dispute Surveyor Slusher's specific declaration as to
the contents of the generator log; Ms. Hrybiniak does not even claim to
have reviewed the prior owner's log book. Further, the Hrybiniak assertion
that the "generator does run, is tested routinely, and is documented as
such" does not establish how often tests have been performed (annually?
monthly?), nor what those tests involve, and does not establish program
compliance. I also note that her assertion is written in the present tense.
Inasmuch as CMS subsequently found the facility in substantial compliance,
it is hardly surprising - though not relevant to this inquiry - that the
generator does run, is tested, and the testing is
documented. The Hrybiniak declarations tell us nothing about what was
going on with the generator between January 1999 and the date of the survey,
August 12, 1999. See Price Hill Nursing Home, DAB No. 1781,
at 19 (2001) (where the facility was unable to document that it
inspected and tested its emergency generator on a regular basis, the Board
sustained the deficiency finding that the facility did not make adequate
provision for emergency lighting). Accepting Regional Administrator Hrybiniak's
general assertions as true thus does not undermine the survey findings. In its Surreply, Petitioner also asserts, for the first
time, that "the malfunctioning generator was only one of several generator's
(sic) at the facility. Other generators were available." However, nothing
in the record supports this assertion, or the apparent inference that
emergency power was therefore available at all times. Regional Administrator
Hrybiniak makes no such claim in either of her declarations. No exhibit
refers to any other generators. See e.g., CMS Ex. 2. Presumably,
Petitioner, in its plan of corrections, would have mentioned the availability
of an alternative source of power. Again, counsel's assertions about events
are not competent evidence and are properly disregarded. Community
Nursing Home, DAB No. 1807, at 13-14 n.5 (2002). I therefore disregard
counsel's gratuitous assertion. Finally, with respect to potential harm, which Petitioner
characterizes as not "even a reasonable risk of minimal harm," Regional
Administrator Hrybiniak notes that no residents were on respirators, and
those on oxygen concentrators had battery backups. Hrybiniak Declaration,
para. 2. The requirement for emergency power goes well beyond protecting
residents with special respiratory needs. Indeed, the rules here address
specifically the need for emergency lighting, and with good reason. Implicit
in these LSC requirements for emergency lighting is the recognition that
a nursing facility cannot safely be plunged into darkness without jeopardizing
resident health and safety. Thus, with respect to the facility's alleged failure to provide emergency lighting, CMS has presented uncontradicted evidence that on the day of the survey, the generator did not function, so that the facility could not provide emergency lighting or power, and that the facility's emergency generator log showed no indication that, since January 1999, the facility had run weekly tests, nor that the emergency generator had been run under a load. Although they purport to address the emergency lighting issue, neither the Hrybiniak declarations nor any other credible evidence or argument disputes these specific surveyor findings. I therefore conclude that CMS has satisfied its prima facie case, and that the facility has not met its burden of establishing by a preponderance of the evidence that it was in substantial compliance with federal LSC requirements for emergency lighting.
During the survey ending August 13, 1999, and again during
the October 5, 1999 revisit survey, the surveyors cited conditions inconsistent
with a sanitary, orderly, and comfortable interior. Specifically, in August:
CMS Ex. 3 at 3; Beuschlein Declaration at 2, para. 5. Surveyor Beuschlein explains that the plastic mattress cover was cracked open, and that the mattress and cover were stained. Review of Resident #93's records disclosed that he had diarrhea and bowel incontinence. Id.; CMS Ex. 28 at 1.
CMS Ex. 3 at 3; McClure Declaration at 2, para. 5.
CMS Ex. 3 at 3; Cobb Declaration at 2, para. 6.
CMS Ex. 3 at 3; McClure Declaration at 2, para. 6.
CMS Ex. 3 at 3; McClure Declaration at 2, para. 7.
CMS Ex. 3 at 4; McClure Declaration at 2, para. 8.
CMS Ex. 3 at 4; McClure Declaration at 2, para. 9.
CMS Ex. 3 at 4; McClure Declaration at 2, para. 10.
CMS Ex. 3 at 4; McClure Declaration at 3, para. 11.
CMS Ex. 3 at 4; McClure Declaration at 3, para. 12.
CMS Ex. 3 at 4; McClure Declaration at 3, para. 13.
CMS Ex. 3 at 4; McClure Declaration at 3, para. 14.
CMS Ex. 3 at 4; McClure Declaration at 3, para. 15.
CMS Ex. 3 at 4; McClure Declaration at 3, para. 16.
CMS Ex. 3 at 4; Cobb Declaration at 2, para. 7. When a survey team returned to the facility for the October 5, 1999 revisit, it listed the following specific observations:
CMS Ex. 4 at 7; Grimes Declaration at 6, para. 12.
CMS Ex. 4 at 7; Grimes Declaration at 6, para.
13.
CMS Ex. 4 at 7; Grimes Declaration at 7, para. 14.
CMS Ex. 4 at 7; Cobb Declaration at 8-9, para. 29.
CMS Ex. 4 at 7; Cobb Declaration at 9, para. 30.
CMS Ex. 4 at 7; Grimes Declaration at 7, para. 15.
CMS Ex. 4 at 7; Grimes Declaration at 7, para. 16.
CMS Ex. 4 at 8; Cobb Declaration at 9, para. 31.
CMS Ex. 4 at 8; Grimes Declaration at 7, para.
17.
CMS Ex. 4 at 8; Grimes Declaration at 8, para. 18.
CMS Ex. 4 at 8; Grimes Declaration at 8, para.
19.
CMS Ex. 4 at 8; Grimes Declaration at 8, para.
20. Petitioner does not challenge any of these specific findings,
nor, with one exception, argue that the findings do not constitute deficiencies.(16)
In her declaration, Regional Administrator Hrybiniak, who was present
for the August survey, does not challenge any of these surveyor observations.
Instead, Petitioner asserts that the facility provides full time housekeeping
staff who maintain a regular cleaning schedule of the facility; points
out that the rate of facility-generated infections is low; argues that
the August survey was conducted within two days after Petitioner began
operation of the facility, so it was cited for conditions over which it
had no control; and argues that, because the facility is used continuously,
"at any given time areas within the facility may be observed to be unclean."
P. Brief at 3; Hrybiniak Declaration at 2, para. 3. Petitioner offers no specific comment on the deficiencies
found during the October survey. Thus, in August, the surveyors found a facility layered
with dirt and grime, sorely in need of substantial cleaning and repairs.
And when the survey team returned for the October revisit, the facility
was still neither clean, nor in good repair. Throughout the facility,
floors around the baseboards were caked with thick black dirt, and handrails
had dirt and debris in the crevices. The surveyors described numerous
instances of stains and dried spills on walls, chairs, and floor, and
stained ceiling tiles. In both August and October, the survey findings
describe a facility interior that was not sanitary, orderly, and comfortable.
Such conditions do not satisfy regulatory requirements. 42 C.F.R. �
483.15. See Community Nursing Home, DAB No. 1807, at 18
(Surveyor observations, as recorded in the survey report form, found credible
in the absence of any evidence from the Petitioner that refuted the findings). That Petitioner may have had in place a full-time housekeeping
staff, as well as policies and procedures for cleaning and maintaining
the facility, does not satisfy the requirement that the facility actually
be kept clean and orderly. 42 C.F.R. � 483.15(h)(2). Community Nursing
Home, DAB No. 1807, at 18 ("Assertions that efforts are being made
to come into compliance or that Petitioner's staff is overworked do not
constitute a meaningful defense to the allegations of noncompliance.")
That, notwithstanding its conditions, the rate of facility-generated infection
might have been low is fortuitous, but that fact(17)
does not establish facility compliance and does not indicate the absence
of potential harm to residents. The potential dangers posed by an ill-maintained
environment are not limited to increased risk of infection: holes in the
floor tile, sharp edges, exposed wires, chipped and rusty metal all increase
the risk of injury. Moreover, even if I accept the suggestion that living
in an unsanitary and disorderly environment does not by itself represent
actual harm to residents, neither the statute nor regulation requires
that actual harm to residents be demonstrated as a prerequisite for imposing
a remedy on a provider who is not in substantial compliance with participation
requirements. The potential for more than minimal harm is sufficient
to demonstrate a failure of substantial compliance without a finding of
actual harm. Koester Pavilion, DAB No. 1750, at 37 (2000); CarePlex,
DAB 1627, at 10 (1997). Nor do I accept Petitioner's suggestion that these conditions are inevitable because the facility is "in constant use." The surveyors were not citing an occasional spill, speck of dust, or scrap of clutter; they described the kinds of conditions resulting from inadequate cleaning and repair over time. That the facility (like all other participating facilities) is "in constant use" does not excuse Petitioner from maintaining a sanitary, orderly, and comfortable interior.
Finally, Petitioner suggests that its environmental and
other deficiencies be excused because of its recent acquisition of the
facility.(18) However, in its CarePlex
decisions, CarePlex of Silver Spring, DAB No. 1683 (1999) and DAB
No. 1627 (1997), the Appellate Panel, relying on statutory and regulatory
construction, as well as sound policy reasoning, concluded that a new
owner does not enjoy immunity from compliance with participation requirements
simply because it acquired a deficient facility. In CarePlex, the
facility was surveyed the day after it changed ownership, and many of
its significant deficiencies were the result of long-standing conditions
that required significant time and effort to correct. As the Appellate Panel noted there, the statute provides
no "grace period" during which a new owner may operate in violation of
the participation requirements by showing good faith efforts to begin
to improve the facility. If anything, the Act suggests Congressional concern
that facilities undergoing changes in ownership might need additional
scrutiny. Thus, by statute, if a standard survey has not already been
conducted under normal time frames, a special survey may be conducted
within two months of a change in ownership to determine if the change
caused any decline in the quality of care. Act, section 1819(g)(2)(A)(iii)(II).
The Board observed that a survey conducted within two months or less of
a change in ownership "obviously" may pick up deficiencies caused by conditions
that began under a prior regime. Yet Congress made no special provision
to reduce the responsibility of new owners for deficiencies found during
these surveys. The regulations provide that, upon a change of ownership,
the existing provider agreement is automatically assigned to the new owner,
subject to all applicable statutes and regulations and to the terms and
conditions under which it was originally issued, including, but not limited
to (1) any existing plan of correction; and (2) compliance with applicable
health and safety standards. 42 C.F.R. � 489.18(c) and (d). The regulation
plainly holds new owners to compliance with all participation requirements
from the time of the assignment of the agreement and therefore supports
the conclusion that all providers are subject to the normal enforcement
authorities, regardless of how long they have owned or operated the facilities. The Appellate Panel also noted that CarePlex could have
declined assignment of the existing provider agreement, and instead applied
to participate in the program once it was able to meet the participation
requirements.
DAB No. 1627, at 7; DAB No. 1683, at 5. The Appellate Panel concluded that the legal basis for imposition of the CMP is not undercut by the uncontested evidence that the facility engaged in efforts to improve the operation and upgrade the facility during the period. The purpose of notifying a noncompliant provider that a CMP may be imposed until it achieves substantial compliance is to provide an incentive for prompt improvements and corrections. DAB No. 1683, at 5. See 42 C.F.R. � 488.402(a). The fact that such efforts were undertaken does not preclude the enforcement of a CMP for the period of noncompliance; to rule otherwise would render notice that a CMP may accrue until substantial compliance is achieved a toothless threat. DAB No. 1683, at 5.
DAB No. 1627, at 4. Petitioner here is thus responsible for the facility conditions, regardless of who initially created them.
Resident #44 was bedfast; she had severe muscle contractures, including in her arms, and the parties agree that she was at high risk for skin breakdown. Indeed, according to Petitioner, her diagnoses -- CVA, hypertension, osteoarthritis, dysphasia, congestive heart failure, and diabetes -- made skin breakdown unavoidable. P. Brief at 5, Hrybiniak Declaration at 2-3, para. 4a. See also McClure Declaration at 3-4, para. 18.(19) Resident #44's physician therefore ordered "heel protectors
on at all times (w/ankle rings)[and] bilateral elbow protectors on at
all times." P. Ex. 1 at 1. Resident #44's care plan, responding to her
risk for skin break-down, called for "heel protectors and elbow protectors
as ordered." P. Ex. 1 at 8. Similarly, Resident #90 had a history of skin breakdown,
and also had orders in place for bilateral heel protectors "at all times,"
bilateral elbow protectors "at all times for preventive measure," and
for a cone splint for his hand to be worn from 7 AM to 7 PM, then taken
off at bedtime. Resident #90 had paralysis on his right side as the result
of a stroke, and his right hand was severely contractured. The cone splint
was designed to hold his hand partially open to avoid worsening the contractures.
P. Ex. 2 at 2, 4, 6, 9; Cobb Declaration at 3, para. 8. Resident
#90's care plan acknowledged these problems, and, among other measures,
called for "heel protectors as ordered," "elbow protectors as ordered,"
and "cone splint as ordered." P. Ex. 2 at 16-17. Yet on three days of the survey, the surveyors observed
Resident #44 without elbow protectors. Specifically, at 2:00 P.M. on August
10, 1999, she was lying on her elbow on her right side without protectors.
Throughout the day on August 11, 1999, she was observed without the protectors.
On August 12, at 8:15 AM she had no protectors; and at 8:55 AM she was
observed lying on her elbow on her left side without the elbow protectors.
CMS Ex. 3 at 5-6; CMS Ex. 23; McClure Declaration at 4, para. 18. The surveyors observed Resident #90 on August 12 at 8:30
AM (awake and in bed), 9:15 AM (sleeping), and 11:30 AM (up in a chair
with his arms on the arm rest) without elbow protectors. They observed
him in a geri chair in the dining room at 1:50 PM without elbow protectors,
heel protectors, or hand splint. CMS Ex. 3 at 6, CMS Ex. 22 at 4. Petitioner does not deny the surveyor observations, but asserts that such observation "does not mean much," because
Hrybiniak Declaration at 2, para. 4a. Petitioner
also asserts that "there is no requirement for a physician's order for
elbow/heel protectors. It is nursing judgment whether or not these need
to be applied;" that residents can and do remove, shift, or displace the
protectors. They "are anticipated to be routinely moved, dislodged, or
out of place;" and that elbow/heel protectors are not needed when in bed
because the resident is on a pressure relief mattress. P. Brief at 5-6;
Hrybiniak Declaration at 2-3. Petitioner also points out that Resident
#90, a hospice patient who died in October 1999, was routinely agitated
and uncooperative, but was "nonetheless" on a pressure-relieving mattress,
"which obviates the need for heel and elbow protectors." P. Brief at 5-6. I accept, for purposes of this decision, that nursing staff made their rounds at 8 AM and 2 PM, but that fact does not mean, and Petitioner does not assert, that the surveyors just happened, consistently, to observe these residents during those limited moments that nursing staff had removed protectors in order to provide care. Indeed, the timing of the nursing rounds would not explain the absence of Resident #44's protectors throughout the day on August 11, nor as late as 8:15 and 8:55 AM on August 12, nor the absence of Resident #90's protectors at 8:30 AM, 9:15 AM, 11:30 AM, and 1:50 PM.(20) I note also that Petitioner has not challenged the surveyors'
specific observations -- that Resident #90 was awake and in bed at 8:30,
sleeping at 9:15, sitting up in a chair with arms on the arm rest at 11:30,
and that Resident #44 was twice observed lying on an elbow without protectors
-- and those observations are inconsistent with the suggestion that the
residents were being examined and treated at those times. Thus, the record
establishes that the protectors were not in place at all times, as ordered
by the treating physicians and dictated by the plans of care. Petitioner suggests, without citing actual support for
the suggestion, that nursing staff appropriately determined that the protectors
were not necessary. Again, counsel's assertions about events or standards
of medical care are not competent evidence and are properly disregarded.
Community Nursing Home, DAB No. 1807, at 13-14 n.5. Moreover, for
each of these individuals, the treating physician determined that the
resident required protectors and ordered them. The interdisciplinary team
agreed, and incorporated the physician orders into the resident's plan
of care. The regulations require that the facility provide care "in accordance
with the comprehensive assessment and plan of care." 42 C.F.R. � 483.25.
That Petitioner failed to do so violates the regulation, and creates a
risk for more than minimal harm to individuals who were at high risk for
developing pressure sores. Petitioner also suggests, again without support,
that the residents themselves might have removed the protectors. If, for
any reason, the facility is unable to keep the protectors in place, as
required by physician order and the care plan, that fact should be documented,
and then considered by the interdisciplinary team in developing the plan
of care. The resident medical records suggest no problems with keeping
the protectors in place, much less any consideration of such problem by
the interdisciplinary teams. P. Exs. 1 and 2.
Resident #68 was diagnosed with multiple sclerosis, dysphagia
(difficulty swallowing), iron deficient anemia, and dermatitis. P. Ex.
3 at 1. She had a gastrostomy tube for feeding, was bed-ridden, and had
multiple contractures, such that she was unable to reposition herself.
P. Ex. 3 at 12, 43, 84; CMS Ex. 21; Grimes Declaration at 2, para.
5. The parties agree that she was at high risk for developing pressure
sores, and, in August 1999, she had a stage II open sore on her left buttock,
and a stage II open sore on her left hip.(21)
P. Ex. 3 at 48-73, 81; Grimes Declaration at 2, para. 5. According
to treatment records, a pressure sore on her left elbow had healed, so
the facility stopped treatment for that on July 23, 1999. P. Ex. 3 at
60-61; Grimes Declaration at 2, para. 5. Resident #68's physician
ordered pillowed pressure relieving devices on both feet and both elbows
at all times. P. Ex. 3 at 18; Grimes Declaration at 2, para. 5. Yet at 1:00 PM and again at 2:00 PM on August 10, 1999,
the surveyor observed Resident #68 in bed, turned on her left side, with
pressure relieving devices on her right elbow and both feet, but none
on her left elbow, which was resting directly on the mattress. On August
11, 1999, at 10:30 AM, 3:00 PM, and 5:30 PM, the surveyor, with the nurse,
observed the resident's left hip had a 6 cm by 4 cm pressure sore with
thick yellow slough. The left buttock area had an 8 cm by 4 cm stage II
red and bloody pressure sore. The surveyor observed dried, yellow drainage
on the resident's gown directly under her left elbow, and the left elbow
had a 2 cm by 3 cm stage II pressure sore with yellow slough. CMS Ex.
3 at 7-8; P. Ex. 3 at 8, 13; Grimes Declaration at 2-3, para. 6;
see P. Ex. 3 at 10. Although Petitioner suggests in its brief that Resident
#68 "can still remove or protest the wearing of protective padding," (P.
Brief at 6), it offers no evidence to support this assertion. The medical
record does not mention her protesting or removing protective padding;
no evidence is proffered from any of the staff who cared for her; and
even the Hrybiniak Declaration makes no such claim.(22)
Regional Administrator Hrybiniak simply states that the sores were unavoidable
and that the provider did what was reasonable -- provided a pressure-relieving
mattress -- to prevent sores from developing. Hrybiniak Declaration
at 3, para. 6. Resident #93 had open pressure sores on his heels and
ankles, with physician orders for heel protectors while in bed, and a
history of pushing his heel/ankle bandages out of place. P. Exs. 4 at
3, 7, 14, 21, 31, 36, 37; CMS Ex. 3 at 8; CMS Ex. 28. At approximately
3:00 PM, August 11, 1999, a surveyor observed his return from the whirlpool
to his room. The surveyor watched as a nurse removed from his feet two
pillowed heel protectors, soiled with dried bloody drainage. These dirty
heel protectors had been applied directly against Resident #93's open
pressure sores on his ankles and heels following his whirlpool bath. According
to the surveyor, the nurse was upset that the dirty heel protectors had
been reapplied in this way. The nurse cleansed the areas on the ankles
and heels, and bandaged the open sores. She then reapplied the same dirty
heel protectors against the clean bandages. CMS Ex. 3 at 8; CMS Ex. 28.
Beuschlein Declaration at 2-3, para. 7, 8. Petitioner makes no effort to challenge or defend staff actions in applying the bloody heel protectors directly to Resident #93's open sores immediately following his whirlpool treatment. With respect to the nurse reapplying the protectors after bandaging the areas, Petitioner asserts in its brief that the soiled heel protectors were replaced with fresh protectors. But no evidence supports this claim. Only two people had first hand knowledge as to whether the dirty heel protectors were re-applied, the surveyor and the nurse. The facility provided no declaration from the nurse. Moreover, in her declaration, Regional Administrator Hrybiniak does not claim that the nurse applied clean protectors. Instead, she, whose background and training are in social work, asserts that applying the bloody heel protector to the bandaged foot "merely establishes that the heel protector had contact with the outside of the surface of a bandage." Hrybiniak Declaration at 3, para. 6. Although I do not doubt that, after dressing the pressure
sores, the nurse reapplied the soiled heel protectors, I make no finding
regarding the appropriateness of the application of the soiled heel protectors
to the bandaged sores. Petitioner offers no credible evidence to counter
the CMS declarations as to the dangers presented by applying contaminated
heel protectors to the dressed wounds; however, on cross examination,
Petitioner might have been able to undermine the surveyor opinions. Nor is it necessary to make such a finding in order to
conclude that the facility was out of compliance with 42 C.F.R. � 483.25.
The relevant question here is: did the facility "take all necessary precautions"
to promote healing, prevent infection, and to prevent new sores from developing.
If so, and the resident develops sores anyway, I could find no deficiency.
But, if the evidence establishes that the facility fell short of taking
all necessary precautions and the resident develops pressure sores, then
the regulation is violated. Koester, DAB No. 1750, at 32. Petitioner argues that it "did what was reasonable;" however, the Appellate Panel rejected that standard in Koester. The facility is obliged to go beyond what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed. Koester, DAB No. 1750, at 32. Allowing Resident #68, a high-risk individual to lie, unprotected, on vulnerable points, in contravention of physician orders, does not establish that the facility took "all necessary precautions." Similarly, applying soiled heel protectors directly on to Resident #93's open sores does not establish that the facility took "all necessary precautions" to prevent infection.
The surveyors cited a long list of deficiencies in dietary
services. Petitioner challenges some, but not all, of these, raising factual
disputes that, for these purposes, I resolve in Petitioner's favor. Specifically, first, at 9:55 AM on the morning of August
10, 1999, Surveyor Carole Cobb observed that the floors throughout the
kitchen and behind equipment were dirty with spills and debris. CMS Ex.
3 at 9; Cobb Declaration at 4, para. 11. Petitioner does not challenge
the observation, but, in his declaration, Food Service Manager Alejandro
Bayalan explains that the facility's practice is to clean the dishes first,
then the floor, so as to avoid having to clean areas twice. The surveyor
happened to observe the area after the morning meal, during the time that
the kitchen and the dishes were being cleaned. Bayalan Declaration
at 2, para. i. According to Petitioner's exhibits, breakfast is served
at between 7:15 and 8:15 (P. Ex. 6 at 1); the kitchen floor is mopped
between 1:15 to 2:30, (P. Ex. 6 at 2) and mopped again at 7 PM. P. Ex.
6 at 8. This raises some factual questions, which, for purposes of summary
judgment, must be resolved in Petitioner's favor. Second, Surveyor Cobb noted that, on August 10, 1999,
paper supplies were stored on the floor in the dry storage area, and were
still there on the following day. CMS Ex. 3 at 9; Cobb Declaration
at 4, para. 11. Again, Petitioner does not deny the observation, but questions
its significance. Food Service Manager Bayalan notes that Tuesday is delivery
day for the facility so if paper supplies were observed on the floor,
it was from the delivery. Of course this does not explain why the supplies
were still there on the following day. More significant, however, Manager
Bayalan also asserts that all such supplies were wrapped inside a cardboard
box, presenting no risk of contamination. This creates a genuine controversy,
so, for summary judgment purposes, I will accept that the supplies were
stored on the floor, but, because of the way they were packed, presented
no deficiency. Third, Surveyor Cobb describes a box of sugar cookies
open to the air and potential contamination. CMS Ex. 3 at 9-10; Cobb
Declaration at 5, para. 15. Manager Bayalan responds that the facility
purchases only individually wrapped cookies, so any cookies the surveyor
observed would have been individually wrapped and sealed. Bayalan Declaration
at 1, para. d. Again, this raises a genuine controversy which, for purposes
of summary judgment, must be resolved in the Petitioner's favor. I therefore
assume that these cookies were appropriately wrapped and sealed. Fourth, Surveyor Cobb reports that uncovered coffee filters
were stored in the area with unclean items and clutter. CMS Ex. 3 at 10;
Cobb Declaration at 7, para. 21. Food Service Manager Bayalan points
out that 190 degree water is poured over coffee filters, which essentially
sterilizes them at the time of use. Bayalan Declaration at 1, para.
e. For summary judgment purposes, I accept his claim. Fifth, Surveyor Cobb reports that the water faucets in
the hand wash sink in the dishroom were not working. CMS Ex. 3 at 10;
Cobb Declaration at 7, para. 22. Food Service Manager Bayalan denies
the charge, asserting that all faucets worked. Bayalan Declaration
at 2, para. k. This is a dispute of fact, and, for purposes of the summary
judgment, I accept his assertion. Sixth, Surveyor Cobb notes that three of four dishes inspected
at the tray line were stored wet and had specks of egg and food on them.
CMS Ex. 3 at 10; Cobb Declaration at 7-8, para. 25. Food Service
Manager Bayalan responds that, before racking, plates are washed in 120
degree plus water with a sterilizer/sanitizer and are rinsed in water
at not less than 140 degrees. According to Manager Bayalan, city codes
require the facility to air dry plates before use. Anything remaining
on the plates after the washing process has been sanitized. Bayalan
Declaration at 2, para. h. For purposes of summary judgment, I will
consider this in Petitioner's favor, and do not find this a deficiency. Finally, Surveyor Cobb observed two trays of cooked chicken
on the stove without heat. She reports staff statements that it was out
to cool so that it could be handled. CMS Ex. 3 at 11; Cobb Declaration
at 8, para. 26. According to Manager Bayalan, the chicken was on the table
"in the typical method of transfer from the oven to move to the steam
table container." Bayalan Declaration at 2, para. f. Again, this
appears to present a factual dispute, which I resolve in Petitioner's
favor for purposes of summary judgment. On the other hand, Petitioner does not challenge other
significant deficiencies cited by the survey team: Surveyor Cobb is a registered and licensed dietician of
long-standing. Cobb Declaration at 1, para. 2. She observed a previously
opened container of hot bacon dressing, dated March 19, 1999, stored in
the dry storage area. The container label instructed that it be refrigerated
after opening, and the top of the container was bulging. Surveyor Cobb
notes that the bulging container indicates likely contamination and the
growth of bacteria or mold, and that such improper storage of a perishable
product puts residents at risk for food poisoning, infection, or allergic
reactions. CMS Ex. 3 at 9; Cobb Declaration at 4-5, para. 13. Petitioner
does not challenge the observation, nor the dietician's opinion. Second, Surveyor Cobb observed, stored on a shelf in the
dry storage area, a container of previously opened soy sauce with a label
stating that it was to be refrigerated after opening. Again, she explains
that such manner of storage creates a risk of bacteria or mold growth,
that could cause food poisoning or other infection. CMS Ex. 3 at 9; Cobb
Declaration at 5, para. 14. Again, Petitioner does not challenge the
findings. Third, Surveyor Cobb reported that a measuring cup was
stored in a large container of sugar. She explains that the measuring
cup comes into direct contact with a kitchen worker's hands, which could
contaminate the cup with bacteria that would be transferred to the sugar.
CMS Ex. 3 at 10; Cobb Declaration at 5, para. 16. Petitioner does
not challenge these findings. Fourth, Surveyor Cobb observed that the microwave had
dried-on food spills inside, and noted that this creates a breeding ground
for bacteria that could contaminate food placed in the microwave, unless
the food is cooked for a long enough time at temperatures hot enough to
kill the bacteria. CMS Ex. 3 at 10; Cobb Declaration at 6, para.
17. Again, Petitioner does not challenge these findings. Fifth, the hand wash sink and the cover of the garbage
container below it were dirty with old food spills and debris. CMS Ex.
3 at 10. Petitioner does not challenge this observation, nor Surveyor
Cobb's assertion that this dirt and debris increases the risk of kitchen
workers contaminating their hands, and attracts insects and rodents. Cobb
Declaration at 6, para. 18. Sixth, potholders on the shelf next to the serving area
were dirty. CMS Ex. 3 at 10. Again, Petitioner does not challenge this
observation, nor Surveyor Cobb's opinion that they could be breeding grounds
for bacteria, which could contaminate dishes with which they come into
contact. Cobb Declaration at 6, para. 19. Seventh, the table on which the steamer was stored had
dried food spills and debris on it. Again, Petitioner does not challenge
this observation, nor Surveyor Cobb's opinion that this presents a potential
breeding ground for bacteria, which could contaminate plates, utensils,
or food placed on the table, and that such food spills can attract insects
and rodents that spread disease and contamination. Cobb Declaration
at 6, para. 20. Eighth, the facility had no ceiling in the dishwashing
area to protect clean dishes. As surveyor Cobb explains, this condition
creates the risk of contamination because the dust, grease, and other
grime, which builds up on the difficult-to-clean overhead pipes, can fall
on to the dishes or utensils below. CMS Ex. 3 at 10; Cobb Declaration
at 7, para. 23. Petitioner disputes neither the observation, nor Surveyor
Cobb's opinion. Ninth, the underside of the shelf over the steam table
had dried food splatters, which, according to Surveyor Cobb, provides
a breeding ground for bacteria that could contaminate utensils or food
placed on the table below, and could attract insects and rodents. CMS
Ex. 3 at 11; Cobb Declaration at 8, para. 27. Petitioner challenges
neither the observation, nor Surveyor Cobb's opinion. Finally, the meat slicer was covered with a black plastic
bag that was not identified to be safe for use on food contact surfaces.
CMS Ex. 3 at 10. Food Service Manager Bayalan admits that the meat slicer
was covered, but declares, irrelevantly, that the facility's failure to
cover it could be considered a deficiency as well. Bayalan Declaration
at 2, para. g. Petitioner, however, misses the point of the deficiency,
which was that the facility had not assured that the plastic used to cover
the slicer was safe for use on food contact surfaces. The slicer must
be covered, when not in use, but the facility must also ensure that the
covering itself is safe. As Surveyor Cobb explains, some plastics contain
harmful chemicals that can leech into foods and cause adverse reactions
in people consuming those foods. Cobb Declaration at 7, para. 24.
Even though Petitioner responds, it has not challenged the finding or
the deficiency. I therefore find no fact in dispute here. Thus, even after resolving all disputed facts in Petitioner's favor, the undisputed evidence establishes significant instances of unsanitary conditions that created the potential for causing more than minimal harm to facility residents. The facility was therefore not in substantial compliance with program participation requirements for dietary services. 42 C.F.R. � 483.35.
The regulations are explicit that the facility must provide
regular in-service education, of no less than 12 hours per year, to its
nurse aides. In reviewing the facility's in-service training records,
the surveyor, a registered nurse, determined that during calendar year
1998, 14 of the facility's 29 nurse aides had received fewer than the
required 12 hours of in-service training. All of these employees were
hired prior to January 1998. She verified this finding with the administrative
nursing staff. CMS Ex. 3 at 11-12; Pierce Declaration at 2, para.
5. Petitioner offers no evidence to counter the surveyor
finding,(23) except the declaration from
Regional Administrator Hrybiniak that, as new owners, Petitioner "cannot
therefore speak to what condition the facility's records may or may not
have been in nor the policies, procedures or practices of the prior operator."
Hrybiniak Declaration at 4, para. 7. As discussed at length above, a new owner does not enjoy
immunity from compliance with participation requirements simply because
it acquired a deficient facility. New owners are subject to the normal
enforcement authorities, regardless of how long they have owned and operated
the facility. CarePlex of Silver Spring, DAB No. 1683 and DAB No.
1627. Thus, the undisputed evidence establishes that the Petitioner
did not provide its nurse aides with the required in-service training. For all of these reasons, I conclude that from August
13, 1999, until October 21, 1999, the facility was not in substantial
compliance with program participation requirements, specifically 42 C.F.R.
�483.15 (Environment), 42 C.F.R. �483.25 (Quality of Care), 42 C.F.R.
� 483. 35 (Dietary Services), 42 C.F.R. � 483.75 (Administration), and
42 C.F.R. � 483.70(a) (Life Safety Code). I next consider whether the amount of the CMP, $400 per day, is reasonable.
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). My "inquiry should be 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." CarePlex
of Silver Spring, DAB No. 1683, at 8. Petitioner limits its argument to the facility's financial
condition, one of the factors set forth in 42 C.F.R. � 488.438(f). However,
evidence of the facility's financial condition are not appropriately before
me because Petitioner neither timely raised the issue, nor timely presented
its evidence relevant to the issue. If a facility contends that its financial condition or
some other factor makes a CMP unreasonable, the facility must raise that
contention on a timely basis before any question would arise as to
CMS's responsibility for producing evidence as to that factor. Community
Nursing Home, DAB No. 1807, at 22, et seq.; Emerald
Oaks, DAB No. 1800 (2001). Where either party fails to take advantage
of its opportunity to submit evidence of a facility's financial condition,
that opportunity is waived. Community Nursing Home, DAB No. 1807,
at 15-16. In Community Nursing Home, the Appellate Panel
affirmed an ALJ refusal to admit untimely evidence of a facility's financial
condition. The Appellate Panel noted that, while CMS must and the ALJ
may consider a facility's financial condition in determining whether the
amount of a CMP is within a reasonable range, the facility must initially
raise that issue as a basis for disputing the reasonableness of the amount
of the CMP. Where Petitioner did not raise the issue in its request for
hearing, its response to CMS's motion for summary disposition, or its
initial brief, the Board reasoned that the evidence of its financial condition
was not relevant to any timely-raised issue in dispute before the ALJ,
and the ALJ properly exercised his discretion by excluding it. Here, Petitioner's hearing request, filed December 30,
1999, does not raise the issue of the facility's financial condition affecting
the reasonableness of the CMP. I do not consider its general challenge
to the amount of the CMP sufficient to raise the issue under the Emerald
Oaks and Community Nursing Home analysis. Nor did Petitioner
attempt to add the issue when it submitted its readiness report, filed
June 27, 2000. Petitioner did not raise the issue until it filed its brief,
almost two years after filing its hearing request. Moreover, even if the issue had been properly raised,
Petitioner supports its claim with evidence that I decline to admit because
it is untimely. Petitioner bases its case on the declaration of Bert A.
Cummins, accompanied by a document that purports to be an income statement
report, which were submitted for the first time with Petitioner's brief
on November 29, 2001. The parties were expected to file their complete
prehearing exchanges by December 4, 2000, almost a full year earlier.
The matter was scheduled for hearing on September 18, 2001. We held a
prehearing conference on September 10, 2001, prior to which Petitioner
should reasonably have been expected to review its exhibits and witness
list. During the continuation of the conference call on September 19,
2001, I specifically advised the parties that no additional exhibits or
witnesses would be allowed without a showing of good cause. On September
21, 2001, Petitioner moved to amend and supplement its witness list, which
I denied in a ruling dated October 3, 2001, concluding that Petitioner
failed to show good cause for supplementing its witness lists, and even
that proposed supplement did not list Mr. Cummins as a proposed witness,
nor include this financial document. Now, without even asking leave, Petitioner attempts to
add an additional witness and an additional exhibit. The Civil Remedies
Division procedures provide for the exchange of exhibits and witness lists
in advance of hearing. Under those procedures, if a party attempts to
call a witness who was not listed or offer an exhibit that was not listed
or timely furnished, and the other party objects,
Civil Remedies Division Procedures, Section 4. I therefore decline to admit Petitioner's evidence or
testimony regarding its financial condition and strike the Cummins' Declaration
from this record. Of course, I also strike CMS's documents and declarations
responding to Petitioner's assertions regarding its financial condition.
Further, any argument or evidence submitted by CMS addressing the facility's
financial condition is irrelevant, as the issue was never properly raised.
I consider the record silent as to Petitioner's financial condition. I now consider the evidence properly before me. In reaching
a decision on the reasonableness of the CMP, I may not look into CMS's
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's factual assertions, nor free to make a wholly independent choice
of remedies without regard for CMS's discretion. Community Nursing
Home DAB No. 1807, at 22, et seq.; CarePlex,
DAB No. 1638, at 8. CMS has imposed a penalty of $400, which is at the lower
end of the mandatory range for non-immediate jeopardy situations. With
respect to the section 488.438(f) factors, the record shows a facility
history of failure to provide services to prevent the formation of pressure
sores, and to promote the healing of pressure sores. During the prior
survey cycle (1998), CMS found deficiencies in this area that resulted
in actual harm. CMS Ex. 13; Weidler Declaration at 4, para. 8.
Housekeeping and maintenance services, which were not corrected until
after the October revisit, had also been cited as deficient during the
prior year, as were dietary services and administration. Id. The deficiencies cited were not insignificant. They directly
affected resident comfort and safety. Because of these factors as well
as the facility history, I am not able to find CMS's determination unreasonable. V. Conclusion For all of the reasons discussed above, I uphold CMS' determination that from August 13, 1999, until October 21, 1999, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. �483.15 (Environment), 42 C.F.R.� 483.25 (Quality of Care), 42 C.F.R. � 483. 35 (Dietary Services), 42 C.F.R. � 483.75 (Administration), and 42 C.F.R. � 483.70(a) (Life Safety Code). The amount of the CMP imposed, $400 per day, is reasonable. |
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JUDGE | |
Carolyn Cozad Hughes Administrative Law Judge |
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FOOTNOTES | |
1. I note that Petitioner's hearing request, though technically satisfying the requirements of 42 C.F.R. � 498.40(b), as articulated by the Board in Fairview Nursing Plaza, DAB No. 1715 (2000), is very broad. The prehearing conference is the appropriate forum in which to narrow the issues and focus the inquiry. See 42 C.F.R. � 498.47; Fairview, DAB No. 1715, at 16 n.7. 2. As discussed below, with respect to Tag K-046, Petitioner conceded that it has no log book or other documentation demonstrating that its emergency generator had been tested or run under a load from January 1999 until the date of the survey. With respect to Tag F-314, Petitioner also indicated that it did not challenge the surveyor finding that Resident #68 did not have a protector on her left elbow. Responding to Tag F-497, Petitioner asserted that its documentation established that it provided in-service training to its nurse aides. I therefore directed Petitioner to identify where among its exhibits such documentation could be found. Summary of Results of Prehearing Conference (Sept. 10, 2001). As discussed below, Petitioner has not identified any documentation of nurse aide training. 3. In its Memorandum in Opposition to Respondent's Motion for Summary Judgment (hereafter, Petitioner's Surreply), filed January 16, 2002, Petitioner, citing my December 12, 2001 letter, characterizes CMS's submission as "untimely and unauthorized," and argues that it should be stricken. In fact, my September 21, 2001 order required CMS to file its prehearing brief and supporting documentation first. I gave Petitioner more than 30 days to respond with its own prehearing brief and supporting affidavits or declarations of witnesses. I then gave CMS three weeks in which to file a reply. We sent the December 12 letter before the due date for CMS' reply brief in order to give the parties maximum notice that the in-person hearing would be canceled. However, it was not intended to foreclose CMS's filing the already-scheduled reply brief. That CMS added a motion for summary judgment to its reply does not render the submission "untimely and unauthorized." In any event, I subsequently afforded Petitioner the opportunity to respond to CMS's Summary Judgment Motion/Reply Brief. I note also that, in reaching my decision here, I do not rely on any of the submissions that accompany CMS's Reply. 4. At the time, since Petitioner received CMS's motion by Federal Express on December 18, 2001, and sent its own Notice of Objections on December 19, 2001, it did not appear that Petitioner intended to file any additional response. 5. Petitioner's claim that the press of business precluded its responding before February rings hollow inasmuch as the week of January 7 was set aside for the in-person hearing in this case. Presumably, the time counsel would have spent preparing for and conducting the in-person hearing became available for responding to CMS's motion. I note also that, in its motion, CMS raised no new issues and made no new arguments aside from pointing out that in its submission Petitioner had raised no issues of material fact. 6. Although Petitioner's brief does not include a citation for Gold Country, we assume it refers to Gold Country Health Center, DAB CR533 (1998). 7. Initially, CMS must set forth the basis for its determination with sufficient specificity for the provider to respond. The provider must then identify which of the findings material to the determination it disputes, and any additional facts that it is asserting. At hearing, "whether or not in-person testimony is introduced as evidence," CMS has the burden of coming forward with evidence which, "when viewed together with any undisputed findings and relevant legal authority," is sufficient to establish a prima facie case that it had a legally sufficient basis for termination. Gold Country, DAB CR 533, at 2. The Petitioner has the burden of coming forward with evidence sufficient to establish the elements of any affirmative arguments or defenses, and 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. Hillman, DAB No. 1611, 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. 8. These findings, discussed in more detail below, are very specific: see, e.g., CMS Ex. 2 at 1-2 ("Between 11:00 and 11:04 AM, in the presence of two staff, the generator failed to start two of two times when the test button was pushed at the main panel in the upstairs courtyard."); CMS Ex. 3 at 3 ("A dirty, cracked regular size patient mattress was placed on the floor beside the bed of resident #93 on all days of the survey. The mattress had areas of dried brown substances and black marks.") 9. Given the plain language of this order, I find puzzling Petitioner's claim that its submissions were "designed to summarize the facts, witnesses, and exhibits" it intended to prove at hearing, but "not intended to be a motion for summary judgment or a complete dissertation of the facts that would be established at hearing." Petitioner's Surreply at 3. 10. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding as a separately numbered heading, and explain each Finding in detail. 11. Petitioner accurately points out that the presence of only one generator for three buildings is not a deficiency. On the other hand, Petitioner is incorrect in declaring "no point to the contention that 'only' one generator serving (sic) three buildings." P. Brief at 2. Inasmuch as one generator provided emergency power to all three buildings, each constructed at a different time, that power source had to comply with both the 1967 and 1981 versions of the LSC. Of course, to meet program requirements, the generator also had to be operational at all times. 12. Until Petitioner filed its Surreply, the record consistently identified Michael Campbell as the facility (Crestview) administrator at the times of the surveys. See CMS Exs. 1, 2, 3, 4, 6, 7, 8, 10, 40, 45. Each facility has only one "administrator," whose qualifications and responsibilities are defined by regulation. 42 C.F.R. � 483.75(d). In her declaration, Regional Administrator Hrybiniak identifies herself as the Regional Administrator for Regal Care. Hrybiniak Declaration at 1, para. 1. Yet, without any support, in its Surreply, Petitioner claims that Regional Administrator Hrybiniak "was Administrator of the facility at the time of the survey." Petitioner's Surreply at 5. Counsel's assertions are not competent evidence and, where unsupported, are properly disregarded. Community Nursing Home, DAB No. 1807, at 13-14 n.5 (2002).
13. Nor were these individuals ever included on Petitioner's witness lists. 14. I discuss below why the facility's change of ownership does not relieve Petitioner of its obligation to meet program participation requirements. 15. Petitioner admits to the white build-up along the black molding, but describes this as the cleaning solution used by the facility. For purposes of a summary judgment ruling, I accept Petitioner's representation. 16. During the August survey, the surveyors cited a rusty grate and white build-up along the black molding of an ice machine. Petitioner argues that the white build-up was the result of cleaning solution, suggesting that such was not a deficiency. For purposes of summary judgment, I accept Petitioner's position. 17. Petitioner offers no solid foundation for Regional Administrator Hrybiniak's assertion, but, for purposes of this decision, I will assume that Petitioner would have been able to lay one. 18. The Hrybiniak declarations are not wholly consistent as to when Petitioner began operating the facility. In her initial declaration, she maintains that the facility was surveyed "within two days after Petitioner started operating [the facility] after a previous owner." Hrybiniak Declaration at 2, para. 3. In her second declaration, she declares that the new owner "had just taken over operation on 8/01/1999," which would have been 11 days prior to the LSC survey. Second Hrybiniak Declaration at 1, para. 1. However, because the change of ownership does not relieve Petitioner of its obligation to demonstrate substantial compliance, the exact timing of that change is not significant. 19. Although Petitioner denies that Resident #44 had pressure sores, and claims instead that she had unavoidable diabetic foot ulcers, her medical records indicate the opposite. In listing the type of ulcer, the facility consistently lists "pressure ulcer" and specifically denies the presence of stasis ulcers (open lesions caused by poor circulation in the lower extremities). P. Ex. 1 at 9, 10, 11, 12, 13. In either case, the facility was bound to follow the plan of care to ensure that she maintained the highest practicable physical well-being. 20. These documented instances, along with the surveyor observations of Residents #68 and #93 (see discussion, infra), suggest a pattern rather than an isolated incident, but even an isolated incident, if serious enough, may indicate problems in the facility since a survey can only be a sample of facility conditions, especially given that this deficiency would not necessarily have been detectable in a record review. Koester, DAB No. 1750, at 37. 21. A stage II pressure sore is characterized by partial loss of skin thickness in the epidermis and/or dermis skin layers. It presents as an abrasion, blister or shallow crater. 22. Again, counsel's assertions about events or standards of medical care are not competent evidence and are properly disregarded. Community Nursing Home, DAB No. 1807 at 13-14 n.5 (2002). 23. In its brief, Petitioner also
gratuitously declares that-- at all times, Crestview provides regular in-services
and education training sufficient to ensure the continuing competence
of the nurse aides. The mandatory hours are met by Crestview, which also
audits all personal files as a check to assure compliance with the regulation. P. Brief at 9. As noted above, counsel's unsupported assertions are properly disregarded. Commuity Nursing Home, DAB No. 1807, at 13-14 n.5. Moreover, during the September 10, 2001 prehearing conference, I specifically advised counsel of the need for documentation to establish facility compliance with the in-service training requirement. See Summary of Results of Prehearing Conference (September 10, 2001). | |