Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Columbus Nursing and Rehabilitation Center,
(CCN: 52-5445),

Petitioner,
v.

Centers for Medicare and Medicaid Services.
Docket No. C-11-571 (On Remand)
Decision No. CR2574
Date: July 27, 2012
DECISION ON REMAND

Petitioner, Columbus Nursing and Rehabilitation Center, was not in substantial
compliance with program participation requirements from June 4, 2007 through August
2, 2007, due to violations of 42 C.F.R. §§ 483.25, 483.25(c), and 483.25(i)(1) (2006). !
The following enforcement remedies are reasonable: a $3,050 per day civil money
penalty (CMP) from June 4 through June 13, 2007; a $200 per day CMP from June 14
through August 2, 2007; a denial of payment for new admissions (DPNA) effective from
July 20 through August 2, 2007; and withdrawal of authority to conduct a nurse aide
training and competency evaluation program (NATCEP) for two years from June 27,
2007 through June 26, 2009, based on substandard quality of care and imposition of a
CMP in excess of $5,000.

' References are to the revision of the Code of Federal Regulations (C.F.R.) in effect at
the time of the surveys, unless otherwise indicated.
My decision as set forth above, originally issued on September 13, 2010,” is unchanged
after my review on remand. The bases for my decision are also unchanged. My opinion
discussing the bases for my Conclusions of Law in the September 13, 2010 decision that
were affirmed by the Departmental Appeals Board (the Board) in its decision dated June
30, 2011,° are set forth in this opinion unchanged from my September 13, 2010 opinion
and are set forth here for the convenience of the Board and the reader. My opinion
discussing the Findings of Fact and Conclusions of Law contested by the Centers for
Medicare and Medicaid Services (CMS) and remanded by the Board are reorganized and
elaborated upon as necessary to permit meaningful review by the Board.

I. Procedural History

Petitioner, located in Columbus, Wisconsin, is authorized to participate in Medicare as a
skilled nursing facility (SNF) and in the Medicaid program as a nursing facility (NF).
Petitioner was subject to surveys by the Wisconsin Department of Health and Family
Services (the state agency) completed on June 27, 2007; July 5, 2007; August 14, 2007;
and September 14, 2007.

CMS notified Petitioner by letter dated July 10, 2007, that the June 27, 2007
recertification and complaint survey determined that Petitioner violated 42 C.F.R. §§
483.13(c), 483.25, 483.25(c), and 483.25(i)(1); and that the violations of these regulations
posed immediate jeopardy and amounted to substandard quality of care. CMS advised
Petitioner that immediate jeopardy lasted for ten days from June 4, 2007 through June 13,
2007 and was abated on June 14, 2007. CMS advised Petitioner that the survey
concluded that Petitioner had numerous continuing deficiencies, none of which posed
immediate jeopardy, and that Petitioner continued not to be in substantial compliance on
and after June 13, 2007. CMS advised Petitioner that it accepted the following state
agency recommendations: to impose a CMP of $8,800 per day for ten days from June 4,
2007 through June 13, 2007; a CMP of $200 per day beginning on June 14, 2007 and
continuing until Petitioner returned to substantial compliance; a discretionary DPNA
beginning on July 20, 2007 and continuing until Petitioner returned to substantial
compliance; a directed plan of correction effective July 20, 2007; termination of
Petitioner’s provider agreement on December 27, 2007, if Petitioner did not return to
substantial compliance before that date; and CMS advised Petitioner that its authority to
conduct a NATCEP was withdrawn. CMS Exhibit (CMS Ex.) 1.

> Columbus Nursing and Rehab. Ctr., DAB CR2241 (September 13, 2010).

> Columbus Nursing and Rehab. Ctr., DAB No. 2398 (June 30, 2011).
CMS notified Petitioner by letter dated July 25, 2007, that a complaint survey completed
on July 5, 2007 found that Petitioner violated 42 C.F.R. § 483.25(h)(1) and that the
violation posed immediate jeopardy from January 29, 2007 to June 14, 2007. However,
CMS advised that the remedies previously imposed continued unchanged. CMS Ex. 2.

CMS notified Petitioner by letter dated October 24, 2007, that a revisit survey completed
on August 14, 2007, found continuing noncompliance. CMS advised Petitioner that the
previously imposed enforcement remedies continued. CMS also advised Petitioner that a
revisit survey completed on September 14, 2007 concluded that Petitioner returned to
substantial compliance effective September 5, 2007; the $200 per day CMP stopped
accruing on September 4, 2007; the total CMP due was $104,600; the DPNA ended on
September 4, 2007; and termination of Petitioner’s provider agreement was rescinded.
CMS Ex. 3.

Petitioner requested a hearing by letters dated August 29, 2007; September 14, 2007;
October 22, 2007; and December 20, 2007. The requests for hearing were docketed as C-
07-682, C-07-729, C-08-56, and C-08-183, respectively, and assigned to Judge Jose
Anglada for hearing and decision. The cases were consolidated by orders dated
November 16, 2007, December 4, 2007, and February 5, 2008, under the docket number
C-07-682. The consolidated case was reassigned to me for hearing and decision on
January 28, 2009, due to Judge Anglada’s assignment to another agency.

A hearing was convened in Madison, Wisconsin on February 3 through 6, 2009, and a
1023-page transcript (Tr.) was prepared. CMS offered exhibits | through 6, 13 through
49, 60 through 72, and 75 through 80. CMS Exs. | through 6, 13 through 18, 22 through
34, 37, 39, 41, 45 through 49, 60 through 65, 67 through 72, and 75 through 80 were
admitted. Petitioner offered exhibits (P. Ex.) 1 through 37 and all were admitted. CMS
called the following witnesses: Surveyor Tina Lubick, RN; Surveyor Cheryl Bott, MSW;
Daniel Berlowitz, MD; and Surveyor Ann Angell, RN. Petitioner elicited testimony from
the following witnesses: Bruce Kraus, MD, Petitioner’s Medical Director; Donna Elford,
LPN; Kurt Hansen, MD; Janet Lutze, RN; Roberta Messer, Petitioner’s Administrator
during the surveys in issue; Martin Metten, Executive Vice-President and Chief
Operating Officer for Petitioner’s owner and operator, Heyde Health System Columbus,
LLC (Tr. at 877); Susan Cary; and Mary Widner, Vice-President for Clinical Services for
Petitioner’s owner and operator. The hearing adjourned sine die on February 6, 2009,
upon the agreement of the parties that Petitioner would file written direct examination for
its remaining witnesses. The parties were directed to file a joint status report after the
filing of Petitioner’s additional direct testimony to advise me whether CMS requested
cross-examination of Petitioner’s remaining witnesses and to propose dates to continue
the hearing, if necessary. Tr. at 1005-09. On March 25, 2009, Petitioner filed the
declarations of Brian Phillips, Barbara Yohn, and Stephanie Foxx, which I have marked
as P. Exs. 38, 39, and 40, respectively. On April 15, 2009, the parties filed their joint
status report in which CMS waived cross-examination of Brian Phillips, Barbara Yohn,
and Stephanie Foxx and the parties proposed three dates to reconvene the hearing to
receive testimony from one additional witness for Petitioner. Subsequently, Petitioner
waived further witness testimony and requested a decision based on the current record by
a letter dated April 24, 2009. P. Exs. 38, 39, and 40 were admitted into evidence.

The parties filed post-hearing briefs on June 15, 2009 (CMS Br. and P. Br., respectively)
and post-hearing reply briefs (CMS Reply and P. Reply, respectively) on July 31, 2009.

On September 13, 2010, I issued a decision in which I concluded as follows:

1. Petitioner did not violate 42 C.F.R. § 483.13(c), Tag F224, as alleged by the
survey completed on June 27, 2007.

2. The declaration of immediate jeopardy related to the alleged violation of
42 C.F.R. § 483.13(c), Tag F224, was clearly erroneous.

3. Petitioner violated 42 C.F.R. § 483.25, Tag F309, as alleged by the survey
completed on June 27, 2007.

4. The determination that Petitioner’s violation of 42 C.F.R. § 483.25 posed
immediate jeopardy was clearly erroneous.

5. Petitioner violated 42 C.F.R. § 483.25(c), Tag F314, as alleged by the
survey completed on June 27, 2007.

6. The determination that Petitioner’s violation of 42 C.F.R. § 483.25(c)
posed immediate jeopardy was not clearly erroneous.

7. Petitioner violated 42 C.F.R. § 483.25(i)(), Tag F325, as alleged by the
survey completed on June 27, 2007.

8. The determination that Petitioner’s violation of 42 C.F.R. § 483.25(i)(1)
posed immediate jeopardy was not clearly erroneous.

9. Petitioner returned to substantial compliance effective August 3, 2007.

10. Petitioner did not violate 42 C.F.R. § 483.10(b)(11), Tag F157, contrary
to the allegations of the August 14, 2007 revisit survey.

11. Petitioner did not violate 42 C.F.R. § 483.25, Tag F309, contrary to the
allegations of the August 14, 2007 revisit survey.

12. The remedies proposed by CMS are not reasonable.
13. Reasonable remedies are a $3,050 per day CMP from June 4 through
June 13, 2007; a $200 per day from June 14 through August 2, 2007; a DPNA
effective from July 20 through August 2, 2007, and withdrawal of approval to
conduct a NATCEP.

CMS requested review by the Appellate Division of the Board. Petitioner did not request
review.* On June 30, 2011, the Board remanded the case to me for clarification of my
factual findings, legal conclusions, and analysis regarding the findings of fact and
conclusions of law contested by CMS. Columbus Nursing and Rehab. Ctr., DAB No.
2398, at 1. The Board remanded for further findings, conclusion, and analysis on my
Conclusions of Law 1, 2, 4, 9, 10, 12, and 13, as listed above (the remanded Conclusions
of Law). The Board affirmed my Conclusions of Law 3, 5 through 8, and 11, and they
are treated as law of the case and not subject to change by me. /d., at 2, 19.

The parties were offered the opportunity to file additional briefing following the remand.
Both parties declined the offer.

IL. Discussion

A. Issues

Whether there is a basis for the imposition of an enforcement remedy; and,

Whether the remedy imposed is reasonable.

B. Applicable Law
The statutory and regulatory requirements for participation of a SNF in Medicare are
found at section 1819 of the Social Security Act (Act) and at 42 C.F.R. Part 483. Section
1819(h)(2) of the Act authorizes the Secretary of Health and Human Services (Secretary)
to impose enforcement remedies against a SNF for failure to comply substantially with

the federal participation requirements established by sections 1819(b), (c), and (d) of the
Act.° The Act requires that the Secretary terminate the Medicare participation of any

‘ Either party dissatisfied with an ALJ decision may request review by the Board. 42
C.F.R. §§ 498.80, 498.82(a)(1).

> Participation of a NF in Medicaid is governed by section 1919 of the Act. Section

1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply
(Continued next page.)
SNF that does not return to substantial compliance with participation requirements within
six months of being found not to be in substantial compliance. Act § 1819(h)(2)(C). The
Act also requires that the Secretary deny payment of Medicare benefits for any
beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with
program participation requirements within three months of being found not to be in
substantial compliance — commonly referred to as the mandatory or statutory denial of
payments for new admissions (DPNA). Act § 1819(h)(2)(D). The Act grants the
Secretary discretionary authority to terminate a noncompliant SNF’s participation in
Medicare, even if there has been less than 180 days of noncompliance. The Act also
grants the Secretary authority to impose other enforcement remedies, including a
discretionary DPNA, CMPs, appointment of temporary management, and other remedies
such as a directed plan of correction. Act § 1819(h)(2)(B).°

The Secretary has delegated to CMS and the states the authority to impose remedies
against a long-term care facility that is not complying substantially with federal
participation requirements. “Substantial compliance means a level of compliance with
the requirements of participation such that any identified deficiencies pose no greater risk
to resident health or safety than the potential for causing minimal harm.” 42 C.F.R.

§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, subpart B. Noncompliance refers to any deficiency

(Continued from preceding page.)

with the participation requirements established by sections 1919(b), (c), and (d) of the
Act.

° Congress granted the Secretary authority to impose enforcement remedies against a
SNF to ensure that a facility that fails to comply with the conditions for participation
promptly returns to and maintains substantial compliance, or its participation in Medicare
is terminated. Act § 1819(h)(2); 42 C.F.R. § 488.402(a); 59 Fed. Reg. 56,116, 56,175-
176 (Nov. 10, 1994); Carrington Place of Muscatine, DAB No. 2321, at 23 (2010);
Embassy Health Care Ctr., DAB No. 2299, at 11 (2010); Taos Living Ctr., DAB No.
2293 (2009). CMS has no more authority under the Act than the authority granted to the
Secretary that is delegated by the Secretary to CMS. The statutory purpose authorized
for imposition of enforcement remedies was satisfied in this case when Petitioner was
found by CMS to have returned to substantial compliance. Petitioner does not contest the
noncompliance at the level of immediate jeopardy found by me and affirmed by the
Board. Thus, it is not clear by what authority or why CMS continues to pursue the
greater enforcement remedies; what interest CMS seeks to vindicate; or why the parties
cannot come to some resolution without wasting further resources of the government and
Petitioner. Nevertheless, I am obliged to comply with the Board’s directions on remand.
that causes a facility not to be in substantial compliance. 42 C.F.R. § 488.301. State
survey agencies survey facilities that participate in Medicare on behalf of CMS to
determine whether the facilities are complying with federal participation requirements.
42 C.F.R. §§ 488.10-.28, 488.300-.335. The regulations specify the enforcement
remedies that CMS may impose if a facility is not in substantial compliance with
Medicare requirements. 42 C.F.R. § 488.406.

The regulations specify that a CMP that is imposed against a facility on a per day basis
will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper
range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose
immediate jeopardy to a facility’s residents and, in some circumstances, for repeated
deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). “dmmediate jeopardy means a
situation in which the provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm, impairment, or death
to a resident.” 42 C.F.R. § 488.301 (emphasis in original). The lower range of CMPs,
$50 per day to $3,000 per day, is reserved for deficiencies that do not pose immediate
jeopardy, but either cause actual harm to residents, or cause no actual harm but have the
potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).

Petitioner was notified in this case that it was ineligible to conduct a NATCEP for two
years. Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may
only use nurse aides who have completed a training and competency evaluation program.
Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to
develop requirements for approval of NATCEPs and the process for review of those
programs. Sections 1819(e) and 1919(e) of the Act impose upon the states the
requirement to specify what NATCEPs they will approve that meet the requirements that
the Secretary established and a process for reviewing and re-approving those programs
using criteria the Secretary set. The Secretary promulgated regulations at 42 C.F.R. Part
483, subpart D. Pursuant to 42 C.F.R. § 483.151(b)(2) and (e)(1), a state may not
approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF
that has been: (1) subject to an extended or partial extended survey under sections
1819(g)(2)(B)(i) or 1919(g)(2)(B)(@) of the Act; (2) assessed a CMP of not less than
$5,000; or (3) subject to termination of its participation agreement, a DPNA, or the
appointment of temporary management. Extended and partial extended surveys are
triggered by a finding of “substandard quality of care” during a standard or abbreviated
standard survey and involve evaluating additional participation requirements.
“Substandard quality of care” is identified by the situation where surveyors identify one
or more deficiencies related to participation requirements established by 42 C.F.R. §
483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or § 483.25
(Quality of Care) that are found to constitute either immediate jeopardy, a pattern of or
widespread actual harm that does not amount to immediate jeopardy, or a widespread
potential for more than minimal harm that does not amount to immediate jeopardy and
there is no actual harm. 42 C.F.R. § 488.301.

The Act and regulations make a hearing before an Administrative law Judge (ALJ)
available to a long-term care facility against which CMS has determined to impose an
enforcement remedy. Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g),
498.3(b)(13). The hearing before an ALJ is a de novo proceeding. The Residence at
Salem Woods, DAB No. 2052 (2006); Cal Turner Extended Care, DAB No. 2030 (2006);
Beechwood Sanitarium, DAB No. 1906 (2004); Emerald Oaks, DAB No. 1800, at 11
(2001); Anesthesiologists Affiliated, DAB CR65 (1990), aff’d, 941 F.2d 678 (8th Cir.
1991). A facility has a right to appeal a “certification of noncompliance leading to an
enforcement remedy.” 42 C.F.R. §§ 488.330(e), 488.408(g)(1), 498.3. However, the
choice of remedies, or the factors CMS considered when choosing remedies, are not
subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope
and severity level of noncompliance determined by CMS, if a successful challenge would
affect the range of the CMP that may be imposed or impact the facility’s authority to
conduct a NATCEP. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to
the level of noncompliance, including the finding of immediate jeopardy, “must be
upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr.,
DAB No. 1726, at 9, 38 (2000), aff'd, 363 F.3d 583 (6th Cir. 2003). The Board has long
eld that the net effect of the regulations is that a provider has no right to challenge the
scope and severity level assigned to a noncompliance finding, except in the situation
where that finding was the basis for an immediate jeopardy determination. See, e.g.,
Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). ALJ
Review of a CMP is subject to 42 C.F.R. § 488.438(e).

The standard of proof, or quantum of evidence required, is a preponderance of the
evidence. CMS has the burden of coming forward with evidence and making a prima
facie showing of a basis for imposition of an enforcement remedy. Petitioner bears the
burden of persuasion to show by a preponderance of the evidence that it was in
substantial compliance with participation requirements or any affirmative defense.
Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing &
Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v.
Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800; Cross
Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611
(1997), aff'd, Hillman Rehab. Ctr. y. United States, No. 98-3789 (GEB), 1999 WL
34813783 (D.N.J. May 13, 1999).

C. Findings of Fact, Conclusions of Law, and Analysis

The parties stipulated prior to hearing that no enforcement remedies were imposed based
on deficiencies cited by a Life Safety Code survey completed on June 13, 2007.
Therefore, no Life Safety Code deficiencies are at issue before me. Tr. at 10; Stipulation
to Limit Scope of Hearing dated May 9, 2008. CMS stated during the hearing that the
deficiency cited by a complaint survey that ended on July 5, 2007, was not the basis for
an enforcement remedy and that the deficiency cited is not at issue before me. Petitioner
agreed that no enforcement remedy was imposed based on the deficiency and that the
deficiency was not at issue before me.’ Tr. at 32-38. Therefore, only the deficiencies
cited by the June 27 and August 14 surveys have ever been at issue before me.

The Statement of Deficiencies, CMS-2567 (SOD) for the survey that ended on June 27,
2007 cites the following deficiencies at the scope and severity (s/s) indicated: 42 C.F.R.
§§ 483.10(b)(11), Tag F157,* s/s G;? 483.13(c), Tag F224, s/s J; 483.13(c)(1)(ii)-(iii),
(c)(2)-(4), Tag F225, s/s D; 483.15(3)(1), Tag F246, s/s D; 483.15(h)(2), Tag F253, s/s D;
483.20 and 483.20(b), Tag F272, s/s D; 483.20(b)(2)(ii), Tag F274, s/s D; 483.20(d) and

7 Petitioner did not disagree with my assertion that I have no jurisdiction to address
issues related to Petitioner being placed on a “special focus” list due, in part, to Petitioner
being cited for a deficiency by the survey completed on July 5, 2007. Tr. at 37.

® This is a “Tag” designation as used in CMS Publication 100-07, State Operations
Manual (SOM), Appendix PP — Guidance to Surveyors for Long Term Care Facilities
(http://www.cms.hhs.gov/Manuals/IOM/list.asp). The “Tag” refers to the specific
regulatory provision allegedly violated and CMS’s guidance to surveyors. Although the
SOM does not have the force and effect of law, the provisions of the Act and regulations
interpreted clearly do have such force and effect. State of Indiana by the Indiana Dep’t
of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest Tissue Ctr. v.
Shalala, | F.3d 522 (7th Cir. 1993). Thus, while the Secretary may not seek to enforce
the provisions of the SOM, she may seek to enforce the provisions of the Act or
regulations as interpreted by the SOM.

° Scope and severity levels are used by CMS and a state when selecting remedies. The
scope and severity level is designated by an alpha character, A through L, selected by
CMS or the state agency from the scope and severity matrix published in the SOM, Chap.
7, § TAO0E. A scope and severity level of A, B, or C indicates a deficiency that presents
no actual harm but has the potential for minimal harm, which is an insufficient basis for
imposing an enforcement remedy. Facilities with deficiencies of a level no greater than
C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of
D, E, or F indicates a deficiency that presents no actual harm but has the potential for
more than minimal harm that does not amount to immediate jeopardy. A scope and
severity level of G, H, or I indicates a deficiency that involves actual harm that does not
amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies
that constitute immediate jeopardy to resident health or safety. The matrix, which is
based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each
level based upon the frequency of the deficiency.
10

483.20(k)(1), Tag F 279, s/s E; 483.25, Tag F309, s/s J; 483.25(c), Tag F314, s/s J;
483.25(e)(2), Tag F318, s/s D; 483.25(i)(1), Tag F325, s/s J; 483.25(1), Tag F329, s/s D;
483.35(d)(1)-(2), Tag F364, s/s E; 483.40(b), Tag F386, s/s D; 483.75(e)(8), Tag F497,
s/s E; 483.75(j)(2)(i), Tag F504, s/s D; and 483.75(0)(1), Tag F520, s/s E. CMS Ex. 13.

A revisit survey was conducted on August 14, 2007, and the surveyors concluded that
Petitioner had corrected all the alleged deficiencies cited by the June 7 survey as of
August 14, 2007, except the deficiencies cited under 42 C.F.R. §§ 483.10(b)(11), Tag
F157, and 483.25, Tag F309. CMS Ex. 62. The revisit survey completed on August 14,
2007, cited Petitioner for the following deficiencies at the scope and severity indicated:
42 C.F.R. §§ 483.10(b)(11), Tag F157, s/s G; and 483.25, Tag F309, s/s G. CMS Ex. 63.
Petitioner disputes all the deficiencies from both surveys but argues, in the alternative,
that Petitioner corrected by August 3, 2007 any deficiency that I may find was correctly
cited by the June 27 survey. Tr. at 38-40.

The conclusions of law from my prior decision, Columbus Nursing and Rehab. Ctr.,
DAB CR2241 affirmed by the Board, establish that Petitioner was not in substantial
compliance with program participation requirements from June 4 through August 2,
2007. Therefore, based on the Board’s decision, it is now not subject to dispute that
Petitioner was not in substantial compliance with program participation requirements
from June 4 through August 2, 2007, due to violations of 42 C.F.R. §§ 483.25 (Tag
F309); 483.25(c) (Tag F314); and 483.25(i)(1) (Tag F325). It is also not subject to
dispute that the noncompliance based on the violations of 42 C.F.R. §§ 483.25(c) (Tag
F314) and 483.25(i)(1) (Tag F325) posed immediate jeopardy for Petitioner’s residents
from June 4 through June 13, 2007. Accordingly, there is a basis for the imposition of an
enforcement remedy based solely upon the affirmed conclusions of law, from at least
June 4 through August 2, 2007. The affirmed conclusions of law authorize a CMP in the
upper range from $3,050 to $10,000 per day for the period June 4 through June 13, 2007,
as proposed by CMS; a CMP in the lower range from $50 to $3,000 per day for the
period June 14 through August 2, 2007; and a DPNA from July 20 through August 2,
2007. Accordingly, it is not necessary to review any of the other deficiency citations
from the June 2007 survey, as I also concluded in my prior decision.

In my prior decision, I concluded that Petitioner returned to substantial compliance on
August 3, 2007, contrary to the CMS allegation that Petitioner continued to be
noncompliant based upon violations of 42 C.F.R. §§ 483.10(b)(11) (Tag F157) and
483.25 (Tag F309). CMS did not appeal and the Board affirmed my conclusion that
Petitioner did not continue to violate 42 C.F.R. § 483.25 (Tag F309) after August 2,

2007, and that deficiency citation is no longer before me. The Board did not affirm, but
remanded my Conclusion of Law 10 that Petitioner did not violate 42 C.F.R. §
483.10(b)(11) (Tag F157). Therefore, whether or not there is a basis for the imposition of
an enforcement remedy for the period August 3 through September 4, 2007, remains and
turns on the single remaining deficiency cited by the revisit survey on August 14, 2007,

11

i.e., whether or not Petitioner was in violation of 42 C.F.R. § 483.10(b)(11) (Tag F157)
during that period. Because the Board did not affirm my conclusions of law as to the
reasonable remedies for this case, the reasonableness of all the remedies also remains an
issue.

I have carefully considered all the evidence and the arguments of both parties, even
though not all may be specifically discussed in this decision. I discuss the credible
evidence given the greatest weight in my decision-making.'° I also discuss the evidence
that I find not credible and weighty and the reasons I find the evidence not credible or
weighty. The fact that evidence is not specifically discussed should not be considered
sufficient to rebut the presumption that I considered all the evidence and assigned such
weight or probative value to the credible evidence that I determined appropriate within
my discretion as an ALJ. The fact that a particular document or specific testimony is not
discussed in this decision indicates that evidence was not considered as probative as the
evidence discussed. There is no requirement for me to discuss the weight given every
piece of evidence offered and admitted in this case, nor would it be consistent with
notions of judicial economy to do so.

1. Petitioner did not violate 42 C.F.R. § 483.13(c), Tag F224, as alleged
by the survey completed on June 27, 2007 (On Remand).

2. The declaration of immediate jeopardy related to the alleged
violation of 42 C.F.R. § 483.13(c), Tag F224, was clearly erroneous (On
Remand).

The surveyors allege that Petitioner violated 42 C.F.R. § 483.13(c) because Petitioner
failed to ensure that Resident 3 “was free of neglect.” CMS Ex. 13, at 14. The regulation
requires that Petitioner develop and implement written policies and procedures that
prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident
property. 42 C.F.R. § 483.13(c). As discussed hereafter, Petitioner had the required
policy. The issue is whether or not the instances when Petitioner failed to deliver goods
and services to Resident 3, show that Petitioner failed to implement its policy. I conclude
that the instances of neglect identified do not show that Petitioner failed to implement its
policy prohibiting neglect.

'° “Credible evidence” is evidence that is worthy of belief. Black's Law Dictionary 596
(18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Id. at 1625.
12

a. Facts

There is no dispute that Petitioner had a policy entitled “Investigation and Reporting of
an Allegation of Misconduct (defined as Abuse, Neglect, or Misappropriation of a
Client’s Property) and Injuries of Unknown Source”, with an effective date of April 1,
1992, and revised through January 11, 2007. P. Ex. 9. I refer to this policy hereafter as
Petitioner’s neglect and abuse policy.

Resident 3 was the subject of all four alleged violations that allegedly posed immediate
jeopardy from the June 27, 2007 survey that are discussed in this decision. The facts
stated here are also pertinent to my discussion of Tags F309, F314, and F325.

On January 20, 2007, Resident 3 was admitted to Petitioner. Resident 3, a woman, was
86 when the survey was done. Her diagnoses included dementia and Alzheimer’s
disease, depression, hypertension, generalized anxiety disorder, psychological pain
disorder, myofascial pain, and osteoarthritis. CMS Ex. 27, at 1-2, 7; P. Ex. 1, at 1, 170.
According to her Minimum Data Set (MDS) with an assessment reference date of
January 29, 2007, Resident 3’s cognitive skills for daily decision-making were severely
impaired; at times she complained of excruciating pain that was assessed to be soft-tissue
pain; she was five feet and six inches tall and weighed 194 pounds; she had a pressure
ulcer and had pressure relieving devices for bed and chair and was on a turning schedule;
she was frequently incontinent of bowel and bladder; she had unsteady gait; had loss of
range of motion of her neck, one arm, and one leg; she used a wheelchair as her primary
mode of locomotion; and she required staff assistance with most activities of daily living
(ADLs). CMS Ex. 27, at 5-9.

A quarterly MDS with an assessment reference date of April 15, 2007, shows no
improvement in Resident 3’s cognition or her ability to engage in activities of daily
living. She remained severely cognitively impaired for daily decision-making; range of
motion had improved in her neck and arm; but she continued to require staff assistance
with ADLs; she remained frequently incontinent of bowel and bladder; she continued to
complain of periods of mild pain occurring less than daily; she had experienced weight
loss; and she was reported to have no pressure ulcers. CMS Ex. 27, at 14-16; P. Ex. 1, at
162-63. Resident 3 was assessed as at high risk for falls on January 21, 2007 and April
15, 2007. CMS Ex. 27, at 25.

Resident 3 died on July 10, 2007, 13 days after the survey that concluded on June 27,
2007, with a cause of death listed as end-stage dementia. P. Ex. 1, at 2-4.

From her admission on January 20 through June 5, 2007, Petitioner’s clinical records
show that Resident 3 received extensive care and services. Physician orders for the
period January 20, 2007 through June 5, 2007, include: treatment for a sore on Resident
3’s buttocks with changes in treatment; occupational therapy evaluation and treatment to
13

improve ADLs and eating skills; physical therapy evaluation and treatment; psychiatric
consults; changes in her medication; treatment for left knee pain and swelling; hip x-rays
twice; ointment and drops for her eyes; orders for laboratory testing for a possible urinary
tract infection (UTI); audiologist consult; authorization to catheterize due to urinary
incontinence; speech therapy consult for oral dysphagia; dental care; diet change to
mechanical soft with ground meat due to pocketing her food and decreased ability to
chew; and treatment for ulcers on her heels. CMS Ex. 27, at 42-82. Resident 3 was seen
for psychiatric consultations on January 25, 2007 (CMS Ex. 27, at 83) and May 3, 2007
(CMS Ex. 27, at 88). She received psychotropic medications for her mood. CMS Ex. 27,
at 249-64. Nursing assessments and nursing notes reflect the care and services Resident
3 received. CMS Ex. 27, at 98-132. The evidence includes Resident 3’s care plan. CMS
Ex. 27, at 146-61. The resident was assessed for pain and received pain medications.
CMS Ex. 27, at 164-232. Her sleep was assessed. CMS Ex. 27, at 233-48. Her risk for
pressure sores was assessed. CMS Ex. 27, at 269-73, 276-77, 283-85. Nurse’s notes
include entries for weekly wound assessments from February 6, 2007 through March 20,
2007 and April 28, 2007 through June 12, 2007. CMS Ex. 27, at 288-91. Her risks for
elopement and wandering were assessed. CMS Ex. 27, at 292. The care and services
Resident 3 received, including ADLs, continence care, and meals and snacks, were
regularly recorded. CMS Ex. 27, at 307-18. Resident 3 received physical, occupational,
and speech therapy. CMS Ex. 27, at 332-93.

Additional care and services received by Resident 3 are described in this decision under
Tags F309, F314, and F325. All the care and services received by Resident 3 that are
specifically mentioned in this decision and all the care and services reflected by the
contemporaneous clinical records in evidence even though not summarized in this
decision, are relevant and material to my conclusion that Petitioner did not fail to
implement its policy prohibiting neglect of its residents.

b. Analysis

The Act requires that long-term care facilities that participate in Medicare or Medicaid
“protect and promote the rights of each resident” including “[t]he right to be free from
physical or mental abuse, corporal punishment, involuntary seclusion, and any physical
or chemical restraints imposed for purposes of discipline or convenience and not required
to treat the resident’s medical symptoms.” Act §§ 1819(c)(1)(A)(ii) (SNFs) and
1919(c)(1)(A)(ii) (NFs). The Secretary has promulgated regulations to implement the
requirements of the Act including 42 C.F.R. § 483.13(c), which provides in pertinent
part:

(c) 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.
14

The term neglect as used in the Secretary’s regulations is the “failure to provide goods
and services necessary to avoid physical harm, mental anguish, or mental illness.” 42
C.F.R. § 488.301. The Board has concluded in several cases that “multiple or sufficient
examples of neglect, even if related to only one resident may support a reasonable
inference that a facility has failed to develop or implement policies and procedures that
prohibit neglect.” Woodland Oaks Healthcare Facility, DAB No. 2355, at 11 (2010)
(citations omitted); Dumas Nursing and Rehab., L.P., DAB No. 2347, at 14 (2010);
Columbus Nursing & Rehab. Ctr., DAB No. 2247, at 27 (2009); Emerald Shores Health
& Rehab. Ctr., DAB No. 2072 (2007); Liberty Commons Nursing and Rehab. Ctr. —
Johnston, DAB No. 2031, at 18 (2006), aff'd, Liberty Commons Nursing and Rehab Ctr.
— Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007); Barn Hill Care Ctr., DAB No.
1848, at 10 (2002); Emerald Oaks, DAB No. 1800, at 18 (2001).

There is no dispute that Petitioner had a policy, though as discussed hereafter, CMS
originally espoused a theory, abandoned on appeal, regarding the specific language of the
policy. The significant issue before me is whether there are examples of neglect of
Resident 3 of such quantity or quality to trigger a reasonable inference that Petitioner
failed to implement its policy prohibiting neglect. I conclude that the instances of neglect
are not sufficient in number or significance to trigger a reasonable inference that
Petitioner failed to implement its policy prohibiting neglect.

(i) Allegations by Surveyors

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.13(c) but the
surveyors make no specific reference to Petitioner’s neglect and abuse policy; they make
no allegations that the policy is insufficient; and they make no specific allegations that
the policy was not implemented. The surveyors do not specifically allege that the alleged
errors and omissions related to Resident 3 show that Petitioner failed to implement its
neglect and abuse policy. CMS Ex. 13, at 13-20.

The surveyors’ allegations are that Petitioner neglected Resident 3 because Petitioner
failed to “adequately or consistently”:

Coordinate and monitor Resident 3’s total health care needs.
Assess, plan, implement, evaluate and modify Resident 3’s
care needs using a multidisciplinary approach to include input
from the primary care provider, physical and occupational
therapies, nursing and the dietitian to minimize Resident 3’s
decline. Provide prompt interventions to prevent further
deterioration, e.g., acute/chronic pain, weight loss, range of
motion and skin integrity changes. Maintain her highest

15

practical level of physical, mental and psychosocial well
being.

CMS Ex. 13, at 14. The surveyors allege that Petitioner’s neglect of Resident 3 resulted
in “significant weight loss, frequent episodes of unresolved pain, decline in activities of
daily living and acquired pressure ulcers.” CMS Ex. 13, at 14-15. The surveyors further
allege that the failure of facility staff to provide necessary services to avoid physical harm
and mental anguish resulted in high levels of pain, the development of an eschar-covered
pressure ulcer, and an unplanned weight loss of 17 percent between January 2007 and
June 2007. CMS Ex. 13, at 15. The surveyors allege three examples of neglect under
Tag F224 in support of the general allegations of noncompliance. "!

(aa) First Example — June 13, 2007, 9:55 a.m. — Not
Neglect

The first example is based upon Surveyor Lubick’s observations on June 13, 2007 at 9:55
a.m. The CMS evidence is inconsistent and potentially misleading.

The SOD states that a surveyor was standing outside Resident 3’s room and heard
Resident 3 moaning loudly and continuously. The SOD alleges that the surveyor
observed five staff members walk by the room and none entered or offered assistance.
The SOD alleges that after about five minutes a therapy staff member entered the room;
offered Resident 3 food; and then left - whereupon Resident 3 began moaning loudly
again. Another staff member was observed to pass the room and not stop. The therapy
staff member returned and advised Resident 3 that a nurse would be in shortly. When the
therapy staff member left the room Resident 3 started yelling that she needed help and the
yelling continued for about three minutes until the nurse arrived. The nurse then left and
returned with juice and cookies. The SOD does not state that Resident 3 continued to
moan or yell after receiving the juice and cookies. CMS Ex. 13, at 16.

'' The Board expressed concern that in my original decision I discussed “neither the
number nor nature of any instances of neglect” or what circumstances surrounded the
instances I thought relevant. Columbus Nursing and Rehab. Ctr., DAB No. 2398, at 12.
I regret any lack of clarity that resulted in this remand. In my original decision, as in this
decision on remand, I considered all the instances of neglect alleged as such in the SOD.
All are relevant because they were alleged by CMS to be the basis for the imposition of
enforcement remedies, though not all are well-founded. In this decision I have attempted
to carefully flag or signal the failures to deliver care and services necessary to prevent
harm, physical or mental, i.e., neglect.
16

Surveyor Tina Lubick testified that she made the observations related to Resident 3 and
drafted the deficiency citation. Tr. at 44. Surveyor Lubick testified that at 9:55 a.m. on
June 13, 2007, she stood outside Resident 3’s room; Resident 3 was moaning very loud;
and during a five minute period she observed five different staff members walk by
without checking on Resident 3. After about five minutes a therapy staff member entered
Resident 3’s room and offered assistance and asked Resident 3 if she was hungry.
Surveyor Lubick did not testify that she entered the room or that she heard Resident 3’s
response. She testified the therapy staff member left and Resident 3 started moaning
again. The therapy staff member returned and told Resident 3 that the nurse would be in.
Surveyor Lubick did not testify as to whether she entered the room, whether the staff
member then left, or whether the resident continued to moan. When the nurse arrived she
asked Resident 3 if she was hungry, the nurse left, and then returned with cookies, juice,
and a banana. Surveyor Lubick did not testify that she entered the room but she testified
to additional information not contained in the SOD, specifically that the nurse gave the
resident cookies, but placed the juice and banana out of the resident’s reach. Surveyor
Lubick did not testify whether or not the resident ate the cookies, but she testified that
Resident 3 continued to moan, though on cross-examination she stated that the resident
was making noises but not loud noises (Tr. at 180). She testified that she did not see the
nurse assess the resident for the cause of her moaning or provide any pain medication but
she also failed to testify whether or not she was in a position to observe. She opined that
the nurse failed to properly assess the resident but a foundation for her opinion, including
her ability to observe is not specified in the SOD and was not developed during
examination. Tr. at 49-51.

The notes Surveyor Lubick made during the survey are also in evidence. Her notes
indicate that at 9:55 a.m. she heard Resident 3 moaning loudly. The notes do not indicate
whether Surveyor Lubick was inside or outside the room, but she records that she saw
five staff walk by the room. The surveyor’s notes show that a therapy staff member
entered Resident 3’s room and asked if the resident needed anything. The therapy staff
member offered to remove the breakfast tray or some other food that was in the room.
The resident started moaning loudly again when the therapy staff member departed,
which causes me to infer that the resident stopped moaning while the therapy staff
member was present. The notes indicate that another staff member passed the room
without stopping and then the therapy staff member returned and advised the resident that
the nurse would be in. According to Surveyor Lubick’s notes, when the therapy staff
member left the room the second time, the resident started yelling “I need help, I need
some help, I need help.” The note shows that at 10:00 a.m., five minutes into the
observation, a registered nurse entered the resident’s room and asked the resident what
she needed help with. The nurse asked if the resident was hungry and said she was going
to get the resident something to snack on and the nurse left. The surveyor notes do not
say that the resident continued to moan or yell at that point. The notes show that the
nurse returned with cookies and juice and put them in the room. The note then states that
the resident was feeding herself the cookies, that the juice was not accessible, and the

17

resident requested a banana. | infer that at some point the surveyor entered Resident 3’s
room to observe the resident eating cookies and the location of the juice, but when she
entered is not clear. The nurse fetched a banana but the surveyor recorded that it was not
left accessible to the resident. CMS Ex. 25, at 12-13. The surveyor notes do not reflect
that the resident was moaning or calling out after the interaction with the nurse and the
eating of cookies by the resident.

The surveyor’s testimony is inconsistent with her recording of her observations in both
the SOD and her surveyor notes. The surveyor notes and SOD are mostly consistent,
though the notes include additional details. I conclude that the surveyor’s recordings of
er observations at the time of the survey on June 13, 2007, are a more reliable source for
the facts than the surveyor’s recollection of events at the time of trial on February 3,
2009, more than 19 months after the events she observed — recollection that may have
been adversely impacted by her preparation for trial. I do not find credible her
recollection that the resident continued to moan after the nurse’s intervention. In fact, the
surveyor did not recall in her testimony that she recorded that the resident was actually
feeding herself cookies and asked for a banana, both facts that are inconsistent with pain
aving any significant impact upon the resident at the time. I infer, based upon the
observations of the surveyor recorded in the SOD and in her notes, that Resident 3’s
behavior was inconsistent with significant pain. I further infer that the resident’s yelling
and moaning were behavioral rather than due to pain because the yelling and moaning of
the resident was resolved by the intervention of the nurse with cookies, which the
resident ate without assistance according to the surveyor’s notes. The facts show that the
resident’s yelling and moaning were effectively remedied, without the need for her
prescribed pain medications, Tylenol and Vicodin. CMS Ex. 13, at 15-16; CMS Ex. 25,
at 12-13; Tr. at 180. I conclude that Surveyor Lubick’s conclusion that the resident was
manifesting symptoms of pain (Tr. at 52) between 9:55 a.m. and 10:00 a.m. on June 13,
2007, is simply incorrect and inconsistent with the evidence in the record. Indeed,

The SOD states that the surveyor interviewed Resident 3’s roommate who
characterized Resident 3 as behaving like a five-month old, describing the resident as
sleeping, mumbling, screaming when staff performed her hygiene and dressed her, and
screaming in the dining room. Even if I fully credit this hearsay evidence, it provides no
insight as to the cause of the resident’s conduct, i.e., whether it was related to pain or a
behavioral manifestation of the resident’s dementia. The roommate’s statement that
Resident 3 slept does show, however, that Resident 3’s pain was not always so severe and
unrelenting as to prevent sleep.
18

Surveyor Lubick pointed to no signs or symptoms of pain except moaning and yelling,
which are also signs and symptoms of a behavioral problem."

Surveyor Lubick does not specifically allege in the SOD which of the activities that she
observed on June 13, 2007, amounted to neglect. Thus, it is necessary to analyze each of
the activities she observed to decide whether or not there was neglect. The broad
regulatory definition of neglect includes two elements: (1) any “failure to provide goods
and services.” and (2) the goods and service are “necessary to avoid physical harm,
mental anguish, or mental illness.” 42 C.F.R. § 488.301. The definition of neglect does
not include an element of knowledge or notice, and the definition of neglect may be
satisfied whether or not staff was aware that the resident was in need of goods and
services to avoid physical harm, mental anguish, or mental illness. The definition of
neglect does not consider the intent of Petitioner’s staff. Neglect may occur even if the
failure to deliver necessary goods and services was unintended. Under a strict application
of the definition of neglect, neglect is complete the instant that staff fails to deliver care
or services necessary to avoid physical harm, mental anguish, or mental illness. The
definition of neglect does not specifically permit a period for a facility to assess and
intervene to meet the need for goods and services. However, it has been noted by the
Board in a number of different SNF enforcement cases that SNF’s are generally not
treated as being “strictly liable” for violations of statutory and regulatory requirements
for participation. See, e.g., Tri-County Extended Care Ctr., DAB No. 1936, at 7 (2004),
aff'd, Tri-County Extended Care Ctr. v. Leavitt, No. 04-04199 (6th Cir. Dec. 14, 2005);
Cherrywood Nursing and Living Ctr., DAB 1845 (2002). A limited number of defenses
have been recognized for specific noncompliance related to adequate showings of
unavoidability, foreseeability, reasonableness of action, and the like. The Board has
recognized, based mostly on interpretation of the regulations, that SNFs are not subject to

'8 For all deficiency citations for which Surveyor Lubick was responsible and about
which she testified, I accept her testimony as credible only to the extent that it is
corroborated by her recording of her observations. This limitation is appropriate as her
testimony to facts that are not recorded in either the SOD or her surveyor notes raises a
significant issue regarding the reliability of her recollection of her observations and the
facts and how her recollection was impacted by preparation for trial. I generally give
little weight to her conclusions or inferences expressed in the SOD, in her notes, and at
hearing, as her testimony related to her observations of Resident 3 between 9:55 a.m. and
10:00 a.m. on June 13, 2007, shows that she was willing to express conclusions or draw
inferences based upon an insufficient factual basis, without considering all the facts,
and/or without considering other possible conclusions or inferences based on the same
facts. The credibility of Surveyor Lubick’s conclusions is in doubt not due to any lack of
truth and veracity, but rather due to an apparent lack of objectivity.
19

enforcement remedies for unavoidable negative outcomes, or unforeseen or
unpreventable circumstances that produce a risk for or an actual negative outcome. Tri-
County Extended Care Ctr., DAB No. 1936, at 7; Woodstock Care Ctr., DAB No. 1726,
at 21, 25, 40 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583(6th Cir.
2003).

Furthermore, not all regulatory or statutory violations, including instances of neglect, are
subject to the imposition of enforcement remedies by CMS. Noncompliance occurs and
CMS is authorized to impose an enforcement remedy, only if a statutory or regulatory
violation poses a risk for more than minimal harm. 42 C.F.R. §§ 488.301, 488.402(b).

I conclude that Surveyor Lubick’s observation that multiple staff passed the resident’s
room without intervening during the first five minutes of the observation is not neglect
within the meaning of 42 C.F.R. § 483.13(c). Certainly the staff that passed without
intervening did not provide care and services to the resident, the first element of the
definition of neglect. However, according to the SOD and the CMS evidence, within the
next three minutes the care and services necessary to avoid any physical harm, mental
anguish, or mental illness were delivered by a therapy staff member and a nurse. The
therapy staff member entered the room, spoke to the resident, made an assessment of the
situation and then left, apparently to locate assistance. The nurse entered the room, made
some assessment of the situation, and decided that a snack was the appropriate
intervention, which proved to be correct. Surveyor Lubick alleges that Petitioner did not
thoroughly assess the Resident’s pain so that an appropriate intervention could be
implemented. I conclude that the surveyor’s conclusion is unsupported. The evidence
shows that at the beginning of the observation it is most likely that Surveyor Lubick was
outside the resident’s room. The evidence does not specifically show that Surveyor
Lubick ever moved into the room where she could have observed an assessment by the
nurse. Furthermore, the evidence shows that the nurse asked the resident at least one
question about what she needed help with. Surveyor Lubick did not record the answer by
the resident or other questions by the nurse. However, there is no dispute that after the
nurse entered the resident’s room and spoke to the resident the nurse determined to obtain
a snack for the resident. The nurse correctly determined that a snack would satisfy or
distract the resident as the chosen intervention, the cookies, were effective without the
need for pain medication or other interventions to address pain.

I further conclude that even if one concluded that neglect occurred in this example, the
evidence does not show a risk for more than minimal harm. As discussed above the facts
are more consistent with the resident’s moaning and yelling being behavioral rather than
due to pain. Further, the resident’s behavior was remedied within 10 minutes by giving
her cookies that she ate. If the event observed by Surveyor Lubick did not pose a risk for
more than minimal harm, then that event did not constitute noncompliance and no
enforcement remedy would be authorized based on that incident.
20

The surveyor alleges that facility staff administered and adjusted the resident’s
psychoactive medications on the theory that her behaviors were related to her dementia
rather than pain. The surveyor also alleges that staff failed to monitor the resident’s
behaviors. Clearly staff was aware of the resident’s behaviors in the circumstance
observed and cited by the surveyor and staff intervened successfully with cookies. I
construe the surveyor’s allegation to be that Petitioner did not have a behavioral care plan
for the resident that involved monitoring, tracking, and analyzing her behaviors and
devising, implementing, and adjusting interventions to address the behaviors. This
allegation, as I have construed it, is discussed in more detail under Conclusion of Law 3.
Conclusion of Law 3 is that Petitioner violated 42 C.F.R. § 483.25 (Tag F309) and the
violation posed a risk for more than minimal harm and amounted to noncompliance. The
noncompliance discussed under Tag F309, constitutes neglect as it is defined in 42 C.F.R.
§ 483.301 and within the meaning of 42 C.F.R. § 483.13(c).

(bb) Second Example — Right Foot Eschar Discovered
June 12, 2007 — Neglect

The second example cited by the surveyor related to the discovery of an eschar on the
plantar region of Resident 3’s right foot on June 12, 2007. The surveyor alleges that a
nurse admitted to her that she failed to check the bottom of Resident 3’s foot during a full
body skin assessment following a shower on June 11, 2007. The nurse also admitted that
she failed to call the resident’s physician prior to being questioned by the surveyor. CMS
Ex. 13, at 18. As discussed hereafter under Tag F314 (Conclusion of Law 5), I have
concluded that Petitioner was not in substantial compliance with the program
participation requirement at 42 C.F.R. § 423.25(c) due to the resident’s development of
bilateral mushy heels in April 2007 and the plantar eschar in June 2007. This failure to
deliver necessary care and services to prevent potential harm amounted to neglect within
the meaning of 42 C.F.R. § 483.13(c).

(cc) Third Example — Unplanned Weight Loss — Neglect
The third example cited by the surveyor is based upon Resident 3’s unplanned weight
loss. Under Tag F325 (Conclusion of Law 7), I discuss in detail that Petitioner was not in
substantial compliance with 42 C.F.R. § 483.25(i)(1) due to the care and services related
to the resident’s weight loss. This failure to deliver necessary care and services to
prevent potential harm amounted to neglect within the meaning of 42 C.F.R. § 483.13(c).

(ii) CMS Arguments
(aa) The Abandoned Theory

CMS argued two theories in its post-hearing brief for why Petitioner violated 42 C.F.R. §
483.13(c): (1) Petitioner failed to develop a sufficient policy to prohibit neglect; and/or
21

(2) the fact that many staff members failed to deliver necessary care and services to
Resident 3 on multiple occasions shows that Petitioner failed to implement its policy
prohibiting neglect. CMS Br. at 7. The surveyor did not allege that Petitioner did not
ave the policy required by the regulation, that the policy was inadequate, or that it was
not implemented. Rather, Surveyor Lubick testified that the deficiency was cited because
she concluded that Petitioner failed to deliver necessary care and services to Resident 3.
Tr. at 157-58. CMS did not allege either theory that it now advances in its prehearing
brief but rather cited only the allegations from the SOD. CMS Prehearing Brief at 12-15.
Petitioner objected to CMS arguing for the first time post hearing, new grounds for a
violation of 42 C.F.R. § 483.13(c). P. Reply at 5, 10-11. Petitioner’s objection is well
taken. Spring Meadows Health Care Ctr., DAB No. 1966 (2005); Livingston Care Ctr.,
DAB No. 1871 (2003). However, considering the substance of the CMS theories reveals
that they are without merit at any rate and no further remedy need be crafted for
Petitioner.

In its Request for Review filed with the Board on November 15, 2010 (Request for
Review) CMS abandoned its theory that Petitioner’s policy was inadequate in its
prohibition of neglect. Request for Review at 11 n.4. I include my analysis of this theory
from my prior decision only to avoid the need for the reader to refer to my prior decision.

CMS did not argue to me that Petitioner did not have a policy but that Petitioner’s policy
pertained only to the investigation and reporting of incidents of neglect and did not
specifically prohibit neglect. CMS Br. at 7. The argument is belied by the policy
document itself. The first sentence of the policy states that Heyde Health System,
Petitioner’s management company, will not tolerate misconduct by employees or

'4 The Board expressed concern that I discussed the merits of the CMS arguments, even
though, I recognized the merit in Petitioner’s position that CMS had potentially engaged
in sharp practice and violation of my Prehearing Order by not disclosing its theory of the
case in advance of trial. Columbus Nursing and Rehab. Ctr., DAB No. 2398, at 10.
Rather than inquire as to the reason why CMS did not raise the arguments prior to
hearing or attempt to fashion a remedy for Petitioner if I concluded there was prejudice
and that a remedy was necessary, I found it more consistent with judicial economy to
simply analyze the CMS theories, which I found to be without merit anyway. I further
recognized that in the case of review by the Board, the Board could disagree with my
conclusion regarding CMS’s conduct of its case finding an error of law, in which case the
Board would either act as the finder of fact or remand for further record development.
The cases cited clearly show that the Board has recognized that due process requires
adequate notice but inadequate notice is tested by the Board for prejudice. Petitioner
suffers no prejudice in this instance as CMS does not prevail on its fresh theory.
22

contractors. Misconduct is defined in the title of the policy as including abuse, neglect,
or misappropriation of client property. P. Ex. 9, at 1. Although it might have been stated
more clearly, the plain meaning of the language of the policy is that Petitioner will not
tolerate and thus prohibits neglect of its residents. CMS further argues that the definition
of neglect set forth in Petitioner’s policy is inconsistent with the regulatory definition.
CMS Br. at 7. “Neglect” is defined by the regulations as “failure to provide goods and
services necessary to avoid physical harm, mental anguish, or mental illness.” 42 C.F.R.
§ 488.301. Petitioner’s policy includes the definition from the regulations but expands
upon that definition. CMS complains that the policy excludes from the definition of
neglect “mere inefficiency, unsatisfactory conduct or failure in good performance as the
result of inability, incapacity, inadvertency or ordinary negligence in isolated instances,
or good faith errors in judgment or discretion.” P. Ex. 9, at 5; CMS Br. at 7-8. CMS did
not explain to me how this argument was pertinent to the case before me. Petitioner
clearly had a policy that prohibited neglect and included the regulatory definition of
neglect. The fact that Petitioner elaborated upon the definition of neglect in its policy is
not alleged to have caused a failure to deliver services to any resident or posed the
potential for more than minimal harm, i.e., no noncompliance is cited on such grounds.
Therefore, there is no issue before me related to the sufficiency of Petitioner’s definition
of neglect. I note however, that the regulatory definition of neglect is limited and neglect
exists under the regulatory definition only if a failure to deliver goods and services could
result in physical harm, mental anguish, or mental illness. A failure that would not
potentially result in such harm would not be neglect under the regulation. The regulatory
definition turns upon the impact of the failing, error, or omission, while Petitioner’s
expanded definition turns upon the cause. Therefore, depending upon the facts of any
given case, Petitioner’s policy may be inconsistent with the regulation. However, that
issue is not raised by the facts before me and it is not for me to give an advisory opinion.

CMS refers to a prior decision of the Board that specifically considered the very policy of
Petitioner at issue before me, Columbus Nursing & Rehab. Ctr., DAB No. 2247 (2009). 8

'S CMS also refers in it Request for Review to a prior “extensive history of
noncompliance” and the fact that the Board has twice upheld findings and remedies
imposed as a result of surveys conducted in the year immediately preceding the surveys
at issue before me in this case. Request for Review at 1. Counsel’s purpose for
emphasizing Petitioner’s history of noncompliance in its brief before me (CMS Br. at 7
n.1) and in the introduction to its request for review is not clear from the context. The
prior surveys and findings of noncompliance are not at issue before me. Presumably
CMS found that Petitioner corrected any noncompliance from the prior surveys to which
CMS refers or CMS would have complied with the Act and Petitioner would have been

terminated from participation in Medicare prior to the surveys that are at issue before me.
(Continued next page.)
23

In that case the Board affirmed the ALJ’s conclusions that Petitioner failed to adequately
investigate a possible incident of abuse (id. at 7); that Petitioner failed to adequately
document its investigation and conclusions (id. at 14); that Petitioner failed to implement
adequate measures to protect the resident in that case from further abuse (id. at 16); that
Petitioner failed to comply with requirements for reporting abuse (id. at 19); and that
Petitioner failed to implement its policy based on facts that multiple staff failed to follow
the policy and that one staff member alleged she never received training on the policy (id.
at 26-27). Contrary to the suggestion of CMS, the Board did not find Petitioner’s policy
defective or insufficient. Rather, the Board in Columbus (DAB No. 2247) upheld the
ALJ’s conclusions that Petitioner fell short of its own policy for investigating and
documenting investigations of suspected abuse or injuries of unknown origin and failed
to show that it otherwise met the requirements of the Act and regulations. Jd. at 12, 15-
16. In upholding the ALJ’s conclusion that Petitioner failed to implement its policy, the
Board commented that it has never required multiple examples of failure to follow a
policy to establish that the policy was not implemented. The Board stated that the issue
“is whether the circumstances presented, viewed as a whole, demonstrate a systemic
problem in implementing policies and procedures.” Jd. at 27 (citation omitted).

(bb) The Failure to Implement Theory

CMS’s second theory is that Petitioner violated 42 C.F.R. § 483.25(c) by failing to
implement its policy prohibiting neglect. CMS argues that the failure to implement the
policy is shown by many staff members failing on multiple occasions to provide Resident
3 with “services to meet her needs related to the prevention of pain, pressure sores, and
weight loss.” CMS Br. at 7, 8. CMS cited to the allegations in the SOD (CMS Ex. 13, at
13-20) in support of its arguments. CMS cites to no other examples from the evidence in
support of its argument. CMS Br. at 8-9.

On appeal to the Board CMS conceded that I recognized the legal standard applied by the
Board in Columbus Nursing & Rehab. Ctr., DAB No. 2247. But CMS argued to the
Board that I erred when I concluded that the noncompliance I concluded existed under
Tags F309, F314, and F325, did not trigger the reasonable inference that Petitioner failed
to implement its policy prohibiting neglect. Request for Review at 9-12.

CMS takes issue with the analytic approach in my decision. CMS recognized that in my
decision I listed some of the many instances where the clinical records show that the

(Continued from preceding page.)
Act § 1819(h)(2)(C). Petitioner’s history of noncompliance is only relevant in this case

to the issue of the reasonableness of the remedies to be imposed and my only
consideration of Petitioner’s history of noncompliance is related to that issue.
24

facility adequately delivered necessary care and services for Resident 3. CMS did not
acknowledge in its Request for Review that the summary of the evidence showing care
and services adequately delivered, clearly shows the complicated nature of Resident 3’s
many health issues. Request for Review at 10. CMS focuses upon my conclusions that
Petitioner was noncompliant with program participation requirements based on violations
of 42 C.F.R. §§ 483.25(Tag F309), 483.25(c) (F314), and 483.25(i)(1) (F325). CMS
argues I committed error by “balancing the evidence of the care that the resident did
receive against the evidence of care that she did not receive.” Request for Review at 10
(emphasis in original). CMS argues that I erred by considering the many instances when
the resident received care and treating those instances as cancelling-out the multiple
instances in which staff failed to provide necessary care and services. Request for
Review at 10.

CMS is correct that I considered all the treatment received by Resident 3 as reflected by
the contemporaneous clinical records in evidence, some of which is summarized
throughout my initial decision and this decision on remand. I also considered that
“neglect” as defined by the Secretary is any “failure to provide goods and services
necessary to avoid physical harm, mental anguish, or mental illness.” 42 C.F.R. §
488.301. I further considered that, as discussed under Conclusions of Law 3, 5, and 7,
Petitioner’s staff failed to provide Resident 3 services and that failure posed a risk for
physical harm, mental anguish, or mental illness. The Board stated in the prior case
involving this Petitioner, that the issue “is whether the circumstances presented, viewed
as a whole, demonstrate a systemic problem in implementing policies and procedures.”
Columbus Nursing & Rehab. Ctr., DAB No. 2247. at 27 (citation omitted). By
considering all the clinical evidence related to Resident 3 and considering both the
adequate delivery of care and services and Petitioner’s deficiencies, I viewed the
circumstances presented as a whole. Contrary to the assertion of CMS there is no simple
balancing. Rather, having viewed the circumstances as a whole, I conclude that
Petitioner’s deficiencies in delivering care and services to Resident 3 were not
symptomatic of a failure to prohibit neglect by a policy. Rather, I conclude that the
evidence, when viewed as a whole, showed that that an earnest and significant effort was
made to deliver necessary care and service to a resident who had an extremely
complicated clinical course that required much care and many services. The instances of
noncompliance discussed hereafter, clearly meet the definition of neglect in 42 C.F.R. §
488.301. However, I conclude that the instances of neglect discussed in this decision are
not sufficient to trigger a reasonable inference that Petitioner failed to implement its
policy prohibiting neglect.

Accordingly, I conclude that Petitioner did not violate 42 C.F.R. § 483.13(c) based upon
the facts related to Resident 3. Because there was no deficiency, the declaration of
immediate jeopardy related to the alleged violation was clearly erroneous.
25

3. Petitioner violated 42 C.F.R. § 483.25, Tag F309, as alleged by the
survey completed on June 27, 2007 (Affirmed).

4. The determination that Petitioner’s violation of 42 C.F.R. § 483.25
posed immediate jeopardy was clearly erroneous (On Remand).

The Board affirmed my Conclusion of Law that Petitioner violated 42 C.F.R. § 483.25
but remanded for clarification of my determination that the declaration of immediate
jeopardy was clearly erroneous. Columbus Nursing and Rehab. Ctr., DAB No. 2398, at
6-10. My factual findings and analysis from my original decision are set forth below
followed by my additional findings and analysis to clarify why the declaration of
immediate jeopardy was clearly erroneous.

a. Findings and Analysis from Original Decision
The regulation requires that:

Each resident must receive and the facility must provide the
necessary care and services to attain or maintain the highest
practicable physical, mental, and pyschosocial well-being, in
accordance with the comprehensive assessment and plan of
care.

42 C.F.R. § 483.25. The surveyors allege in the SOD that Petitioner violated the
regulation in the case of Resident 3 because Petitioner did not deliver care and services
necessary for Resident 3 to be as free of pain as possible. The surveyors allege more
specifically that Petitioner did not adequately or consistently: assess Resident 3 when she
moaned or cried out in pain; provide prescribed pain medication prior to transfers and
care; assess the effectiveness of its pain treatment; assess whether pain contributed to the
resident’s increased anxiety, behaviors, constipation, weight loss, and skin breakdown; or
review the frequency of the need for medication for breakthrough pain; all of which
resulted in Resident 3 suffering unresolved instances of pain. The surveyors allege that
the deficiency posed immediate jeopardy on June 14, 2007, that the immediate jeopardy
was abated on that date, and that the deficiency continued to pose a risk for more than
minimal harm. CMS Ex. 13, at 55.

Resident 3’s diagnoses on admission on January 20, 2007, included psychological pain
disorder, myofascial pain, and osteoarthritis. CMS Ex. 27, at 1-2, 7; P. Ex. 1, at 1, 170.
According to her admission MDS with an assessment reference date of January 29, 2007,
Resident 3’s cognitive skills for daily decision-making were severely impaired and at
times she complained of excruciating pain that was assessed to be soft-tissue pain. The
MDS indicates that she asked repetitive questions; voiced repetitive anxious complaints
or concerns; and displayed a sad, pained, worried facial expression on a daily basis. She
26

was also noted to withdraw from activities and to have reduced social interactions. CMS
Ex. 27, at 5-6; P. Ex. 1, at 168-69. The narrative to the January MDS indicates that
Resident 3 had repetitive anxious concerns about wanting to go home but she was easily
redirected. P. Ex. 1, at 177; CMS Ex. 27, at 19. A quarterly MDS with an assessment
reference date of April 15, 2007, shows she remained severely cognitively impaired for
daily decision-making and she continued to complain of periods of mild pain less than
daily. She was noted to withdraw from activities and to have reduced social interaction
but there was no indication of repetitive questions, anxious complaints or concerns, or a
sad and pained expression. CMS Ex. 27, at 14-16; P. Ex. 1, at 162-63.

A care plan dated February 1, 2007, addressed Resident 3’s diagnosis of arthritis with
approaches of assessing the resident’s pain every shift and as necessary; administering
Tylenol (Acetaminophen) as ordered; and observing her for non-verbal pain indicators,
with the goals of the resident being pain free or at an acceptable level of pain and able to
participate in ADLs without pain. The care plan was updated on June 6, 2007, with the
intervention to use Vicodin (Acetaminophen and the narcotic Hydrocodone) as necessary
if pain is severe. The care plan was further updated on June 15, 2007, with the
intervention to administer narcotics as ordered. CMS Ex. 27, at 153; P. Ex. 1, at 266. A
Care Conference Checklist dated April 24, 2007, indicates that the resident should be
repositioned as needed for pain and that the resident seemed more awake due to reduction
of her psychotropic medication. P. Ex. 1, at 256.

Resident 3 had care plans addressing depression and anxiety with agitated features and
her Alzheimer’s dementia, dated February 1, 2007. Interventions for the depression and
anxiety included daily assessment of mood, administering medication as ordered,
monitoring, and updating the physician with the goal that her mood remains stable until
May 2007, July 2007, and October 2007. Interventions for her dementia included
encouraging the resident to attend activities, maintaining a routine, one-on-one
intervention, and medication as ordered, with the goal of maintaining cognitive stability
through May, July, and October 2007. There is no indication that either care plan was
updated except by the addition of new goal dates. P. Ex. 1, at 266; CMS Ex. 27, at 153.
A care plan dated April 2007 with goal dates of July 2007 and October 2007, lists as
problems depression and anxiety that is not easily altered. Undated additions to the list of
problems on the preprinted plan include deterioration in mood, calling-out, and repetitive
physical movements. Interventions include monitoring, medication as ordered, including
the resident in activities, encouraging the family to visit, reminiscing with the resident,
allowing the resident to ventilate her feelings, and using validation. Listed goals were
keeping her mood stable for three months and keeping her free from side effects of
medication for 90 days. There are no dates written on the care plan to indicate that the
27

problem or interventions were updated after April 2007 and before the survey.'° P. Ex. 1,
at 261; CMS Ex. 27, at 155. Resident 3’s dementia care plan dated April 2007 with goal
dates of July and October 2007, lists problems that she is not easily altered, deterioration
in behavioral symptoms, socially inappropriate, and resists cares. The following
interventions are listed: distract, use validation, encourage participation in activities,
socialization, encourage family visits, administer medication as ordered, use a behavior
log, psychiatric consults as necessary, psychotropic medication as ordered, monitor for
side-effects, and approach at a later time as necessary. The plan appears to have been
updated on June 26, 2007, but the meaning of the entry “T.G. #2 added 6/26/07” is not
clear. P. Ex. 1, at 262; CMS Ex. 27, at 156.'” The resident’s psychosocial well-being
care plan is dated April 2007, and it indicates that the resident is adjusting to the nursing
home. Interventions include introducing the resident to other residents, including her in
activities, encouraging family visits, use of validation, and changing the subject. Goals
include adjustment to the facility and a new roommate with target dates of July 2007. P.
Ex. 1, at 262; CMS Ex. 27, at 156.

Petitioner’s pain assessment policy required that a pain assessment be completed on each
resident who had acute, chronic, or suspected pain, on admission, upon return from the
hospital, if there was a significant change, quarterly for each resident on analgesics, or on

'6 The copy of the document placed in evidence by Petitioner includes additional entries
that do not appear on the copy introduced by CMS that was obtained by the surveyor
during the survey. For example, the document obtained by the surveyor only listed
depression but the copy introduced by Petitioner includes the notation “[ with] anxiety”
with an unreadable date and initials next to the notation. Other additions are the entries
that there was deterioration in mood, calling out, and repetitive physical movements but
they are undated. I infer that the subsequent entries were added during or after and in
response to the survey. I do not consider subsequent remedial measures adversely to
Petitioner.

'T Comparison of Petitioner’s exhibit and the CMS exhibit reveals that this care plan was
also altered after CMS obtained its copy during the survey. Additions include reference
to additional problems of deterioration in behavioral symptoms, socially inappropriate
behavior, and resisting care. The intervention “T.B. #2 added 6/26/07” was clearly added
during the survey between two interventions that are on both copies. The intervention of
re-approaching also appears only on Petitioner’s copy and is undated. | infer that the
entries that are not present on the copy obtained by the surveyor were added during or
after and in response to the survey. I do not consider subsequent remedial measures
adversely to Petitioner.
28

order of the physician or clinical manager. The policy provided that a “Pain Management
Flow Sheet” could be used for follow-up until the pain was under control. The policy
also required that the interdisciplinary team address pain management on the care plan
and that pain management be addressed in the weekly summary. CMS Ex. 27, at 162.

Pain assessments by Petitioner’s staff show that the resident suffered pain. A pain
assessment form dated January 20, 2007, indicates that Resident 3 had generalized pain
characterized as a dull ache in all joints due to osteoarthritis and myofascial pain. The
severity of her pain is not indicated but an acceptable level of pain is marked as three on a
scale of one to ten with ten being worst. Medications indicated for pain are Celebrex (a
nonsteroidal anti-inflammatory drug (NSAID)) and Darvocet (Acetaminophen and a
narcotic). CMS Ex. 27, at 164; P. Ex. 1, at217. A pain assessment dated April 15, 2007,
describes Resident 3 as having chronic, generalized joint pain due to osteoarthritis, which
was worse in the morning. Non-verbal indicators that Resident 3 was experiencing pain
were guarding and grimacing. The form indicates that Resident 3 was unable to respond
to the question of what level of pain was acceptable, but a note indicates that the resident
denied discomfort or pain. APAP (Acetaminophen) 500 mg is listed as the medication
used. CMS Ex. 27, at 166; P. Ex. 1, at 215. A follow-up/quarterly assessment summary
dated June 12, 2007, indicates that Resident 3 had increased complaints of discomfort
and pain at different times in different areas. Resident 3 had prescriptions for Vicodin
and Tylenol to be used as necessary for facial grimacing and complaints of pain. The
note indicates that she had a recent reduction in her Clonazepam and that the “[t]eam is
wondering if yelling out/behaviors may be related to this.” CMS Ex. 27, at 167; P. Ex. 1,
at 216. Though this seems to be a pertinent question and important to Petitioner’s
defense in this case, I find no evidence that prior to the survey Petitioner developed a care
plan for addressing the behavior or for systematically assessing and tracking the behavior
to attempt to distinguish between behaviors due to pain and those due to dementia or
some other cause. A Pain Assessment form dated June 15, 2007 indicates that the
resident was unable to assess the severity of her pain but she was crying. The narrative
indicates that when the resident was approached she started crying out and when asked if
she hurt, she responded that she wished she did. The note indicates that Resident 3 calls
out with any interaction and sometimes when no one is present. The note states that both
staff and the physician are monitoring closely and that pain and psychotropic medications
are being adjusted to address progressing dementia and “failed dose reduction.” P. Ex. 1,
at 188-89.

The clinical record, though inconsistent in the reporting of instances of pain and
behaviors and incomplete in recording the effectiveness of interventions, shows that
Resident 3 obtained relief of pain from medication and non-pharmacological
interventions. Resident 3’s Medication Administration Form (MAR) for April and May
2007 show that she received a daily dose of Acetaminophen, two tablets of 500
milligrams once a day for arthritis. However, the order was discontinued on May 30,
2007. P. Ex. 1, at 328, 340, 356. Nurse’s Notes and 24-Hour Reports for April 2007
29

show that Resident 3 complained of a headache on April 6, leg pain on April 7, leg pain
on April 9, and leg pain and bilateral ankle pain on April 12, 2007. The report shows that
each complaint of pain in April 2007 was addressed with Tylenol with relief of the pain.
P. Ex. 6, at 1-6, 133-34. Nurse’s Notes and a 24-Hour Report dated April 14, 2007,
indicate that Resident 3’s family wanted her Clonazepam reduced and her Zoloft
increased. P. Ex. 6, at 5, 135. Nurse’s Notes record a complaint of bilateral foot pain on
April 30, 2007. P. Ex. 1, at 135. Nurse’s Medication Notes for April 2007, show that
Resident 3 was given Tylenol or Acetaminophen ten times on seven days, April 6, 9, 11,
18, 26, 29, and 30, 2007, for headache, leg, ankle, or foot pain. There is no indication of
whether or not the pain medication was effective in three instances but entries show it
was effective in six instances and ineffective in one instance with no indication other
interventions were attempted. P. Ex. 1, at 355. A MAR for April 2007 lists
Acetaminophen for pain as needed every four hours and shows administration on April 6,
7, 9, 11, 12, twice on 13, twice on 19, 28, and 30. P. Ex. 1, at 354. A pain assessment
ow sheet for May 2007, records complaints of pain on ten days (11 instances), eight
jays the pain was in her legs, one day she was unable to state where the pain was, and
one day just has a question mark. The indicators of pain are verbalization on one
occasion, verbalization and moaning on four occasions, moaning on two occasions,
moaning and yelling on two occasions, and moaning and crying on two occasions. She
was given Tylenol or the generic Acetaminophen seven times, Vicodin four times, and a
Tylenol and Vicodin on one occasion. Non-medication interventions listed are
repositioning, rest, one-on-one time, and fluid. I note that only repositioning is listed as
an intervention in the care plan. Six events are noted to have resulted in decreased
moaning, quiet, or the resident going to sleep after interventions. However, five events
lo not indicate whether the interventions were successful. CMS Ex. 27, at 222; P. Ex. 1,
at 136-38, 346. A Nurse’s Medication Notes form for May 2007 shows that
Acetaminophen was administered on May 1, 2, and 8 for moaning and complaints of leg
pain and that the medication was effective. Vicodin was administered on May 23, 27,
and 28 for moaning and yelling and complaints of leg pain, and the drug was noted to be
effective in one instance but there was no note for the other two instances. P. Ex. 1, at
349. A MAR for May 2007 shows Acetaminophen prescribed to be administered as
needed for pain was given on May 1, 2, 3, 21, 23, and 28 and Vicodin was given on May
23, 27, and 30. P. Ex. 1, at 348. A 24-Hour Report entry on May 21, 2007, contains the
request that something be ordered for Resident 3’s pain as she had only Tylenol 500 mg
and that was not enough. The report indicates that the morning nurse called but the
afternoon nurse noted that no call-back was received. P. Ex. 6, at 14. A 24-Hour Report
entry from the night-shift on May 22, 2007, reflects that Resident 3 was “crying out all
night” and there was no call back from the physician. CMS Ex. 6, at 15 (emphasis in
original). However, an entry from the day-shift indicates a new order for Vicodin, half-
tablet by mouth every six hours as needed for pain. CMS Ex. 6, at 15. Entries on the 24-
Hour Report on May 28 and June 3, 2007 show that she was given Tylenol and Vicodin
for complaints of leg pain and leg cramps. A note also suggests that Resident 3 be
monitored at night related to her calling out but I find no evidence that a plan for doing so

30

was developed or implemented prior to the survey. CMS Ex. 6, at 16-18. An entry on
June 4, 2007, indicates that the resident was crying out all night and she was given
Vicodin; a day-shift note indicates that she cried out with any movement and that her left
shoulder, arm, hip, and leg would be x-rayed to rule out fractures. A note from the
second-shift indicates that the left hip was x-rayed and that the power of attorney wanted
Resident 3’s Clonazepam increased. P. Ex. 6, at 19. Entries in the 24-Hour Report forms
continue to show that Resident 3 was moaning loudly and/or crying on June 5, 6, 7, and
14, 2007. The notes reflect that on June 7 she complained specifically of leg pain and
was holding her right inner thigh and that she was sent to the hospital for x-rays of the
right hip, which were negative. P. Ex. 6, at 20-25.

Nurse’s Notes are consistent with the 24-Hour Reports. P. Ex. 6, at 138-43. The Nurse’s
Notes record that on June 5, 2007, the physician increased Resident 3’s Clonazepam back
to its prior dose. On June 6, 2007, a new order for an increased dose of Vicodin was
obtained to address the resident’s increased moaning. A note dated June 14, 2007 records
that the physician was updated that Resident 3 continues to call-out despite increased
Vicodin, sometimes verbalizing pain and sometimes not. P. Ex. 1, at 139. An Analgesic
Record/Pain Flow Sheet for June 2007 reflects complaints of leg pain on June 1, 2, 4, and
6; a complaint of shoulder pain on June 10; complaints of pain on June 9 and 11, the
location of which could not be determined. The form shows that Resident 3 was given
her scheduled Hydrocodone or a half-tablet of Vicodin with evidence of pain relief in
four instances but no notation of whether the medication was effective in four instances.
CMS Ex. 27, at 231; P. Ex. 1, at 332. A Nurse’s Medication Notes form shows that
Hydrocodone was administered on June 1, 2, 3, 5, and 6 for moaning and/or crying rather
than pain; with the notation on June 3 and 6 that the medication was not helpful; but no
indication of effectiveness on June 1, 2, and 5. P. Ex. 1, at 331. Resident 3’s MAR for
June 2007 indicates that the Hydrocodone could be given every six hours as needed for
pain, with entries showing administration on June 1, 2, 3, 4, 5, 6, and 9, 2007. P. Ex. 1, at
330. Nurses’ Progress Note forms for April and May 2007 do not include any discussion
of Resident 3’s complaints of pain. The June 2007 Nurses’ Progress Note lists a new
order for Vicodin by mouth every six hours on a routine basis for pain and also notes that
staff was awaiting results of a second set of x-rays. P. Ex. 1, at 125-30.

A physician’s note by Bruce Kraus, MD, dated May 24, 2007, indicates that nursing staff
raised questions as to whether Resident 3 may have been having pain but he states that he
is not certain that there is significant pain; he notes that he gave her a prescription for
Vicodin; and that he would try to find a proper balance for pain medication, psychotropic
medication, and anti-anxiety medication. P. Ex. 1, at 106.

A psychiatric consultation was done on January 25, 2007. Resident 3 was reported to
have a history of senile dementia, generalized anxiety disorder, generalized myofascial
pain, osteoarthritis, and major depression. Her depression was evaluated as being under
relatively good control with Zoloft. P. Ex. 1, at 277-79; CMS Ex. 27, at 83-85. A
31

psychiatric consultation was also done on May 3, 2007, to consider her extreme lethargy.
She was noted to have partially treated depression. The psychiatrist recommended
tapering her dose of Seroquel as there was no evidence that she suffered psychosis or
bipolar disorder. She was noted to have a history of dementia, depression, generalized
anxiety, and myofascial pain. She was assessed as obviously demented with short and
long-term memory deficits, a low mood, insight diminished, possibly with thoughts of
hopelessness and helplessness, and poor judgment. Staff reported her to be extremely
lethargic and she told the examiner that she was very tired. P. Ex. 1, at 274-76; CMS Ex.
27, at 88-90. There is no indication in the psychiatrist’s notes that staff complained of
agitation or crying out. A third psychiatric consult was done by the same psychiatrist on
July 5, 2007, following the survey. The psychiatrist indicates in his report that he was
asked to consult as the state surveyors suggested regarding whether Resident 3’s
complaints of pain were being ignored. He concurred with Dr. Kraus that Resident 3 did
not appear to be in any pain at all, though he notes that she continues to seem tired and
lethargic. He opined that her discomfort was secondary to dementia rather than any
actual pain. The psychiatrist does not discuss the basis for his conclusion in this regard;
he does not mention any testing or specific evaluation that he did or how he overcame the
resident’s clear communication deficits; his report does not mention whether he assessed
the resident while she was under the influence of narcotic pain medication; and the record
contains no information regarding the psychiatrist’s qualification to develop a credible
opinion on this issue. I further note that the first two evaluations lasted 40 and 45
minutes respectively, while the post-survey evaluation lasted no more than 25 minutes.
His plan was to stop her Seroquel but continue her on the other psychotropic drugs. He
notes he discussed his plan with staff, though there is no evidence of a change to the care
plan. P. Ex. 1, at 271-72, 487.

On February 15, 2007, Resident 3 was assessed by Social Services as suffering severe
“anxiety, anxious expression, rumination, worring (sic)” and mild to intermittent
complaints of physical pain. P. Ex. 1, at 292. Behavior/Intervention Monthly Flow
Record forms for February through May 2007 show that the only behavior being
monitored was Resident 3’s making paranoid statements. P. Ex. 1, at 284-91. It was not
until June 25, 2007, that Petitioner began tracking Resident 3’s behavior of
“unredirectable,” repetitive, calling-out. The flow record for June 2007 records on three
days the interventions of redirection and one-on-one. P. Ex. 1, at 282.

Surveyor Tina Lubick testified that she made the observations of Resident 3 between
June 12 and 14, 2007. Tr. at 43-45. She testified that when she observed Resident 3 at
12:25 p.m. on June 12, 2007, the resident was yelling that she was cold, not that she was
in pain. A Certified Nursing Assistant (CNA) escorted the resident to her room and
helped her put on a sweater. The CNA asked Resident 3 if she was having pain and she
said she had back pain. The CNA told a licensed staff member that Resident 3 was
complaining of pain, but nothing was done. Surveyor Lubick testified that the nurse
should have assessed Resident 3 and offered pain medication or another intervention.
32

Surveyor Lubick opined that Resident 3 was suffering from unresolved pain. Tr. at 45-
47. Surveyor Lubick testified that she observed Resident 3 at 3:35 p.m. on June 12 and
the resident was moaning and calling out very loudly. Surveyor Lubick testified she
asked Resident 3 what was the matter and she replied that her “legs were breaking.” Tr.
at 47. Surveyor Lubick testified that she spoke with a staff member who explained that
the facility was not certain whether Resident 3 was suffering pain or whether her
complaining was just a behavior. The staff member also advised that Resident 3 was on a
scheduled pain medication and her medications were being adjusted. Surveyor Lubick
opined that the staff should have assessed Resident 3 and determined whether pain
medication or other intervention was appropriate. Surveyor Lubick testified based upon
Resident 3’s MAR (CMS Ex. 27, at 230-31) that as needed medication was available for
Resident 3 but none was administered at the time the surveyor made her observation. Tr.
at 47-49.

Surveyor Lubick observed Resident 3 again on June 13, 2007, at 9:55 a.m. when Resident
3 was moaning loudly. She observed five staff members pass the resident’s room and
none offered assistance. A therapy staff member did enter the room and ask the resident
if she was hungry and then left the room. A nurse came to the room with cookies, a
banana, and juice but she did not leave the banana and juice in reach of Resident 3. She
testified that the nurse never asked about the resident’s moaning or did any other
assessment of the resident. Tr. at 50-51.'"

Surveyor Lubick observed Resident 3 again on June 14, 2007 at 7:55 a.m. while a CNA
was present providing care and Resident 3 was yelling loudly that her legs hurt. The
CNA stopped and stated she would find a nurse but returned and indicated that she could
not find a nurse. When the CNA started providing care the resident again yelled out.

The CNA left again stating that she would find a nurse. The CNA returned and stated the
nurse told her that Resident 3 had Vicodin at 6:00 a.m. and that the nurse had instructed
her to get the resident up and that she would be in to speak to the resident. The surveyor
opined that the nurse should have assessed the resident. Tr. at 54-55.

Surveyor Lubick observed Resident 3 again at 8:20 a.m. on June 14, 2007. Petitioner’s
staff was using a mechanical lift to get the resident out of bed and Resident 3 was
screaming or yelling while staff moved her from bed to bathroom. The surveyor asked
her supervisor to observe too. Petitioner’s director of nursing (DON) also entered the
room and ordered staff to stop care stating that they could not allow the resident to be
uncomfortable. The DON went for pain medication and another nurse came and gave the
resident half of a Vicodin. The surveyor estimated that Resident 3 had been crying out

'S This is the event analyzed in detail under Conclusion of Law 1.
33

for a half-hour. Tr. at 55-56. Surveyor Lubick opined that Resident 3 was experiencing
pain due to the efforts of staff to move her despite the fact that she had received her
scheduled pain medication. She could not opine that the half-Vicodin was effective at
relieving the resident’s pain as she did not see her again until seven hours later. Tr. at 58-
60. However, the surveyor testified based upon the Nurse’s Notes for June 14 at 8:40
a.m. (CMS Ex. 27, at 131) that the Vicodin did not relieve the resident’s pain as she
continued to yell and her physician needed to be contacted for additional instructions. Tr.
at 60-61.

Surveyor Lubick testified that licensed staff did not assess Resident 3 for pain when
alerted by staff; licensed staff did not intervene when they walked by Resident 3’s room
and she was moaning; and licensed staff did not assess whether the resident’s pain
medication was effective. Tr. at 62-63. She also opined that the fact the facility was not
tracking as a behavior Resident 3’s moaning and crying out, was consistent with her
conclusion that the yelling out was due to pain and not a behavior. Tr. at 64. She opined
that the care plan for managing the resident’s pain was not adequate as it did not address
her discomfort with activity or address the use of Vicodin. Tr. at 65-66. She testified
regarding instances when pain medication was not effective that Petitioner’s staff needed
to assess the resident to see if the medication was effective and, if not, then other
interventions needed to be implemented. Tr. at 67. She cites as an example entries in
Nurse’s Notes for April 7, 2007, at 6:45 a.m. that show that Resident 3 was given one
500 milligram Tylenol at 4:30 a.m., at 5:15 a.m. the resident continued to complain of
pain and there was swelling of her left ankle; but there is no indication of the action taken
by the nurse. She testified that a Nurse’s Notes entry for April 12, 2007, shows the
resident complained of pain at 11:45 p.m. on April 11, a Tylenol was given, later at 12:15
a.m. the resident was checked and she continued to complain of pain, but another Tylenol
was not given until 5:15 a.m. when the resident was found to have an elevated
temperature. Tr. at 67-70; CMS Ex. 27, at 123. Surveyor Lubick testified to entries in
the Nurse’s Notes that showed that Resident 3 received Vicodin but that it was not
effective to stop her signs of possible pain; the physician was not advised or the
notification was delayed regarding the effectiveness of the pain medication; and the
physician continued to order the same medication and dosing. Tr. at 76-83; CMS Ex. 27,
at 127-29. She opined that Petitioner violated the regulation and that the violation caused
Resident 3 serious harm. Tr. at 83.

CMS called Daniel Berlowitz, MD who was accepted as an expert in geriatrics and
pressure sores. Tr. at 330-31. Doctor Berlowitz opined that Resident 3 did not receive
the necessary care and services to be as free of pain as possible. He testified that the
clinical record shows the resident had chronic pain that required narcotic therapy to
relieve the pain. He testified that the record shows that Resident 3 specifically stated that
she was in pain on numerous occasions. Her treatment was limited to Tylenol until May
and he opined that she should have been started on stronger medication sooner. He
testified that systematic monitoring of the pain and the effect of pain medication is not
34

reflected in the clinical record and that monitoring should have been done. He testified
that using Tylenol, then escalating to narcotics as needed, and then to scheduled narcotics
was fine, but there was an unduly long time in the transition to the stronger medication
which he attributed to the absence of adequate monitoring of the resident’s pain and the
effectiveness of the medication. He testified that pain has both physical and
psychological components and the fact that she was diagnosed with a chronic pain
syndrome does not mean she did not have real pain. The fact she had pain is reflected by
the fact that she had some relief from pain medication. He opined that pain is serious
arm and that there was no need for someone on comfort care measures such as Resident
3 to be in pain. He testified that Zoloft and Seroquel have no significant pain relieving
properties. He testified that Lorazepam is an anti-anxiety medication and while it has no
pain relieving effect it does have a sedating effect. Tr. at 350-57.

Petitioner called Bruce Kraus, MD, to testify. Dr. Kraus is board certified in internal
medicine. He is Petitioner’s Medical Director. He testified that he has 30 to 40 nursing
ome residents as patients in multiple facilities and he has been caring for long-term care
residents for 30 years. He was Resident 3’s treating physician. He testified that Resident
3 was a complicated case, particularly in the last couple months of her life. He testified
that he or his physician assistant called the facility on a daily basis to check on his
patients, including Resident 3. He testified that Resident 3 was in the late-stage of
Alzheimer’s, initially he could communicate with her, but subsequently she became
confused and did not respond appropriately to questioning. She also had increasing
agitation after about two or three months, the cause of which was the subject of
considerable discussion. Her ability to eat and her mobility also declined. Tr. at 435-41.
He testified that when the resident started falling asleep at meals it was determined to
reduce her anti-anxiety medication due to concern that she was over sedated. He testified
that when her medication was reduced there was an increase in agitation, anxiety, and
moaning at times. He testified that there was concern related to whether the agitation was
due to dementia or pain. The resident would call out but could not articulate whether she
was in pain or not. He testified that there was no change in condition such as trauma or a
broken bone, x-rays were done, but he was never able to determine that she was actually
experiencing a painful condition and he concluded she had no significant cause for pain.
Tr. at 459-63. He conceded however that osteoarthritis could be a cause for pain but it is
usually slow developing and he did not feel the resident had a significant pain problem
during the first couple months at the facility. Tr. at 464. He did not explain why he
discounted the psychological pain disorder and myofascial pain as possible causes of pain
related behavior. He opined that the care Resident 3 received at Petitioner for her
moaning and agitation was consistent with the standard of practice and in some cases
above and beyond. Tr. at 466. He testified that the care and services provided to the
resident were not likely to lead to serious injury, harm, or death. He opined that there
was no potential for more than minimal harm. Tr. at 470-71. Dr. Kraus testified that he
was reasonably certain that Resident 3 was suffering from agitation due to her dementia
rather than pain. Tr. at 501-02.

35

Kurt Hansen, MD, was called to testify by Petitioner and the parties agreed that he was
qualified to render opinions as an expert in the area of geriatric care. Tr. at 661. He
opined that the treatment of Resident 3’s pain was consistent with standards of practice.
He opined that her moaning was related to agitation and behavioral problems secondary
to dementia rather than pain. He testified that the resident’s primary care physician and a
consulting psychiatrist were addressing her symptoms, there were multiple medication
changes to address behavioral symptoms, x-rays were done, psychotropic medications
were used, and pain medication was increased. He opined that the fact increased pain
medication did not stop the resident’s moaning supports his conclusion that the moaning
was not the result of pain. He opined that the resident’s mild osteoarthritis would not
cause pain consistent with the resident’s behaviors rather the osteoarthritis would have
caused pain with movement but the resident would cry-out whether moving or not. He
opined that Petitioner’s care plan was appropriate and not likely to cause serious injury,
harm, death, or more than minimal harm. Tr. at 679-85. Dr. Hansen testified on cross-
examination that he did not know what problems the resident was having with pain prior
to her admission to Petitioner. Tr. at 734. He agreed that he could not rule out that the
resident’s moaning and crying out was due to pain rather than agitation. Tr. at 735-36.

Mary Widner, RN and Vice-President of Clinical Services for Heyde Health Systems,
testified that she was responsible for overseeing the clinical services provided by all the
company’s skilled nursing facilities, including regulatory compliance. Tr. at 928. During
the June and August 2007 surveys of Petitioner, she was the administrator of another
skilled nursing facility owned by Heyde but she collaborated on the plan of correction for
Petitioner. Tr. at 930-31. She testified that she reviewed Resident 3’s chart and she
opined that Petitioner did all it could consistent with the family’s wishes for treating the
resident. Tr. at 974. She testified that the resident was receiving narcotic pain
medication but her crying out was more likely due to her dementia than pain. Tr. at 975.
She testified that to the extent there was a deficiency it was not likely to cause serious
arm or death or more than minimal harm. Tr. at 975.

I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. §
483.25 that Petitioner has failed to rebut. I conclude that Petitioner has failed to establish
an affirmative defense to the violation. I further conclude that the evidence shows that
Resident 3 suffered actual harm” as a result of the violation.

'° This finding is consistent with evidence that Resident 3 suffered either pain or mental
distress. I make the finding not as a substitute for the surveyor’s scope and severity
determination but rather to reflect the seriousness of the deficiency, a finding that is

required when assessing the reasonableness of the enforcement remedies proposed. 42
(Continued next page.)
36

Resident 3’s clinical record that has been admitted as evidence shows that she had
diagnoses that included a psychological pain disorder, myofascial pain, and osteoarthritis.
Petitioner has not presented credible medical evidence that rules out either a
psychological pain disorder or myofascial pain syndrome as a basis for pain. °° Thus,
there was a medical basis for Resident 3 to complain of pain. The care plan dated
February 1, 2007, addressed Resident 3’s diagnosis of arthritis, required that the
resident’s pain be assessed every shift and as necessary; required that Tylenol
(Acetaminophen) be administered as ordered; required observation of the resident for
non-verbal pain indicators; and established the goals that the resident be pain free or at an
acceptable level of pain and able to participate in ADLs without pain. The care plan was
updated on June 6, 2007, with the intervention to use Vicodin as necessary if pain was
severe. The care plan was further updated on June 15, 2007, with the intervention to
administer narcotics as ordered. CMS Ex. 27, at 153; P. Ex. 1, at 266. The care plan did
not include non-pharmacological interventions for pain. However, a Care Conference
Checklist dated April 24, 2007, indicates that the resident should be repositioned as
needed for pain. P. Ex. 1, at 256. Thus, not only did Resident 3 have diagnoses that
established a medical basis for her pain, Petitioner had adopted and modified a care plan
to address the resident’s pain secondary to her arthritis. Surveyor Lubick’s unrebutted
testimony shows that during the survey there were instances when Resident 3 acted as
though she might be in pain, but staff did not respond as required by the care plan. The
Board has repeatedly concluded that a facility’s failure to follow its care plan is a
violation of 42 C.F.R. § 483.25. Venetian Gardens, DAB No. 2285, at 5 (2009).

Petitioner’s attempt to rebut the CMS prima facie case on the theory that the resident was
not suffering pain must fail as the evidence simply does not support such a finding. From
her admission to the time of the survey, Petitioner’s staff and the resident’s treating
physician treated the resident as if she had pain, including care planning to address pain

(Continued from preceding page.)

C.F.R. §§ 488.404(b), 488.438(e) - (f). The finding is made here rather than restating the
evidence and analysis in the part of the decision discussing the reasonableness of the
enforcement remedies to be imposed.

°° There is no evidence before me that Petitioner developed and implemented a care plan
to address the resident’s diagnoses of psychological pain disorder and myofascial pain.
While Petitioner’s failure to deliver care and services pursuant to a properly implemented
care plan for the resident’s psychological pain disorder and myofascial pain would be an
independent basis to find a violation of 42 C.F.R. § 483.25, the surveyors and CMS did
not give Petitioner notice of that deficiency and I do not find a violation for that reason.
37

due to arthritis. The clinical record shows that from the resident’s admission in January
2007 to the time of the survey, there were many instances when the resident complained
of pain or displayed behaviors consistent with pain, and the resident apparently received
relief from pain medications. The record shows that Dr. Kraus continued to treat the
resident as if she had pain, despite his testimony at hearing that he had come to believe
that the resident’s calling out and agitation were due to dementia rather than pain. The
documents show that prior to the survey he questioned whether the resident’s behavior
was due to pain or dementia, but he elected to attempt to find an appropriate mix of pain,
anti-anxiety, and psychotropic medication. P. Ex. 1, at 106. Thus, Dr. Kraus’s testimony
that the resident’s behaviors were due to dementia rather than pain, at least to the extent
that he suggested that that was his opinion during and before the survey, is not weighty or
persuasive.” Dr. Kraus’s testimony is also considered not weighty due to his admission
that he had not reviewed the resident’s clinical record prior to the hearing.

I find that the post-survey psychiatric opinion that the resident was behaving due to
dementia rather than pain (P. Ex. 1, at 271-72, 487) is not persuasive. Two prior
psychiatric consultations were done by the same psychiatrist, and neither addressed any
problem behavior the resident was having due to dementia. It was only after the survey
that the psychiatrist opined that the resident was not suffering pain and I have no
evidence that the psychiatrist did any evaluation or testing or was even qualified to render
such an opinion.

I find that the testimony of Petitioner’s expert, Dr. Hansen, is not weighty as he admitted
that he was not aware of the resident’s history of pain prior to her admission to Petitioner.
Furthermore, he failed to resolve the inconsistency between the fact that pain medication
had been effective in the past with his opinion that the resident was not in pain but was
behaving due to her dementia.

Mary Widner’s opinion that the resident was behaving due to her dementia is not given
weight as the basis for the opinion and her qualification to develop the opinion is not
established. Her opinion that the facility did all it could is simply not credible as it is
based on her review of the clinical record, which shows that the resident’s care plan for
pain only provided for monitoring and assessing pain and administering pain medication,

2! “Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary 596
(18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Jd. at 1625. Thus, while Dr. Kraus’s testimony may be
credible, particularly given his admission that he did not review the clinical record prior
to testifying, his opinions at hearing are simply not as persuasive as the contemporaneous
recordings in the clinical record because he did not review those records prior to hearing.
38

and a separate document that required repositioning. The clinical record does not show
that other possible interventions for pain were attempted and assessed for effectiveness.

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.25 in the case of
Resident 3.

b. Additional Findings and Analysis Related to Immediate
Jeopardy on Remand”

In my original opinion I stated the following regarding immediate jeopardy:

However, the violation does not support a determination of
immediate jeopardy and the determination is clearly
erroneous as it relates to this deficiency. Immediate jeopardy
is present if a provider’s noncompliance caused or is likely to
cause a resident serious injury, harm, or impairment, or death.
The evidence supports a conclusion that the resident, more
likely than not, suffered pain that was not promptly relieved.
Ihave no difficulty concluding that pain amounts to actual
harm. However, given the resident’s history of pain and the
treatment she did receive for pain, it was not “likely” that she
would suffer serious injury, harm, impairment, or death due
to Petitioner’s failure to assess, monitor, and treat her pain
given the facts of this case.

I mistakenly thought this conclusion was amply supported by the long recitation and
discussion of the evidence and the analysis related to the conclusion that CMS made a
prima facie showing of a violation of 42 C.F.R. § 483.25, which Petitioner failed to rebut
by attempting to show Resident 3 suffered no pain. Clearly, the Board perceived conflict
among my conclusions that:

= There was noncompliance because Petitioner’s staff failed to follow care
plans and policy in assessing Resident 3’s signs and symptoms of pain;

2 Tn post-hearing briefing, CMS did not address immediate jeopardy in detail related to
specific allegations of noncompliance, but asserted generally that the declaration of
immediate jeopardy had to be upheld unless Petitioner met the heavy burden of showing
the declaration was clearly erroneous. CMS Br. at 19-20; CMS Reply at 23-24.
39

= Resulting in actual harm to Resident 3 in the form of some unresolved or
unmitigated pain; but,

= The noncompliance that caused actual harm did not rise to the level of
immediate jeopardy as the noncompliance did not cause or was not likely to
cause serious injury, harm, impairment, or death.

The Board also expressed confusion about my analysis discussing the weight and
credibility accorded to the expert opinions relative to the existence of immediate
jeopardy. I discredited the experts’ opinions that Resident 3’s behaviors were not related
to pain but rather her dementia. None of the experts or the surveyor had adequate bases
to distinguish the cause of the resident’s behaviors that all agree could signal pain or
dementia related behaviors. I did not specifically credit or discredit their opinions
regarding the care and services delivered to address the resident’s signs and symptoms.
My error was the presumption that by stating the opinions of the experts without
specifically crediting them, the opinions would be understood to have been credited and
considered weighty unless specifically rejected or minimized. The purpose of this further
analysis is to explain that the expert opinions related to the treatment of the resident’s
signs and symptoms of pain and the effectiveness of that care and treatment (delete: and
other care and treatment), is sufficient to rebut the surveyor’s conclusion that there was
immediate jeopardy. The clinical evidence is consistent with and supports the opinions
of Petitioner’s experts in this regard. Further, while the CMS expert opined more should
have been done sooner and that pain is severe [serious] harm, his testimony does not
bolster the surveyor’s opinion that there was immediate jeopardy.

It is first necessary to consider the meaning of immediate jeopardy, what the Act and
regulations provide, and the principles adopted by various appellate panels of the Board.

The Act requires that if the state survey agency finds that a facility’s deficiencies
“immediately jeopardize the health or safety” of the facility’s residents, the state is to
recommend that the Secretary take action to remove jeopardy and correct the deficiencies
through the appointment of temporary management, or terminate the facility’s
participation. Act § 1819(h)(1)(A). Congress granted the Secretary authority and
required that, if a facility was found to no longer meet the conditions for participation and
the facility’s deficiencies “immediately jeopardized the health or safety of its residents”
the Secretary is to remove the jeopardy and correct the deficiencies through the
appointment of temporary management or terminate the facility’s participation. Act
§1819(h)(2)(A)(i) and (4); see also Act § 1919(h)(3)(B)(i) and (5) (enforcement
procedures for NFs are similar to those for SNFs). The phrase “immediately jeopardize”
is not defined in the statutes. However, the context suggests that Congress intended that
the phrase be given its plain meaning and apply if there was any potential of
instantaneous or proximate, hazard or risk for harm to the health or safety of a long-term
care facility resident.

40

The phrase “immediate jeopardy,” which seems to have derived from the statutory
“immediately jeopardize,” is given a specific and different effect or meaning by the
Secretary through regulation. “/mmediate jeopardy” under the regulations refers to a
situation in which the provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm, impairment, or death
to a resident.” 42 C.F.R. §§ 488.301, 489.3 (emphasis in original). Thus, “immediate
jeopardy” under the regulations refers only to serious injury, serious harm, serious
impairment, or death; whereas the statutory “immediately jeopardize” refers to any
imminent risk to a resident no matter how severe. In the context of survey, certification,
and enforcement related to SNFs and NFs under the regulations, a conclusion by the state
agency and CMS that noncompliance with program participation requirements poses
immediate jeopardy to a facility resident’s, triggers specific regulatory provisions that
require enhanced enforcement remedies, including authority for CMS to impose a larger
CMP than may be imposed when there is no declaration of immediate jeopardy. 42
C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d). The regulations also require
termination of the facility’s provider agreement on an expedited basis or the removal of
the immediate jeopardy through appointment of temporary management. 42 C.F.R. §§
488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10) a finding by CMS that deficiencies pose immediate
jeopardy to the health or safety of a facility’s residents is not an initial determination that
triggers a right to request a hearing by an ALJ or that is subject to review. A finding of
noncompliance that results in the imposition of an enforcement remedy, except the
remedy of monitoring by the state, does trigger a right to request a hearing and is subject
to review. 42 C.F.R. §§ 488.408(g); 498.3(b)(8) and (13). Furthermore, the level of
noncompliance, i.e. scope and severity, is subject to review only if a successful challenge
would: (1) affect the amount of CMP that may be imposed, i.e. the higher range of CMP
authorized for immediate jeopardy; or (2) affect a finding of substandard quality of care
that rendered the facility ineligible to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14) and
(15). Pursuant to 42 C.F.R. § 498.60(c)(2), in reviewing a CMP, the ALJ must uphold
the CMS determination of the level of noncompliance (i.e. scope and severity), unless it
is clearly erroneous. The phrase “clearly erroneous” is not defined by the Secretary.
Many appellate panels of the Board have addressed “immediate jeopardy.” Recently in
Mississippi Care Ctr. of Greenville, DAB No. 2450, at 14 (2012), the Board commented:

3 Some of the often cited decisions are: Lakeport Skilled Nursing Ctr., DAB No. 2435,
at 6 (2012); Liberty Health & Rehab. of Indianola, LLC, DAB No. 2434, at 12, 19
(2011); Yakima Valley School, DAB No. 2422, at 7 (2011); Lutheran Home at Trinity
Oaks, DAB No. 2111 (2007); Daughters of Miriam Ctr., DAB No. 2067 (2007);

(Continued next page.)
41

CMS’s determination that a deficiency constitutes immediate
jeopardy must be upheld unless the facility is able to prove
that the determination is clearly erroneous. 42 C.F.R. §
498.60(c)(2); Woodstock Care Center. The “clearly
erroneous” standard means that CMS’s immediate jeopardy
determination is presumed to be correct, and the burden of
proving the determination clearly erroneous is a heavy one.
See, e.g., Maysville Nursing & Rehabilitation Facility, DAB
No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab
Center — Johnston, DAB No. 2031, at 18 (2006), aff'd,
Liberty Commons Nursing and Rehab Ctr. — Johnston v.
Leavitt, 241 F. App’x 76 (4th Cir. 2007). When CMS issued
the nursing facility survey, certification, and enforcement
regulations, it acknowledged that “distinctions between
different levels of noncompliance . . . do not represent
mathematical judgments for which there are clear or
objectively measured boundaries.” 59 Fed. Reg. 56,116,
56,179 (Nov. 10, 1994). “This inherent imprecision is
precisely why CMS’s immediate jeopardy determination, a
matter of professional judgment and expertise, is entitled to
deference.” Daughters of Miriam Center, DAB No. 2067, at
15 (2007).

The Board’s statement that the CMS immediate jeopardy determination is entitled to
deference is subject to being misunderstood to limit ALJ and Board review of immediate
jeopardy beyond what was intended by the drafters of the regulations. In the notice of
final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2),
discussing the merits of the reviewability of deficiency citations, selection of remedy, and
scope and severity, commented:

We believe that a provider’s burden of upsetting survey
findings relating to the level of noncompliance should be
high, however. As we indicated in the proposed rule,
distinctions between different levels of noncompliance,
whether measured in terms of their frequency or seriousness,

(Continued from preceding page.)

Britthaven of Havelock, DAB No. 2078 (2007); Koester Pavilion, DAB No. 1750 (2000);
Woodstock Care Ctr. DAB No. 1726 (2000).
42

do not represent mathematical judgments for which there are
clear or objectively measured boundaries. Identifying failures
in a facility's obligation to provide the kind of high quality
care required by the Act and the implementing regulations
most often reflect judgments that will reflect a range of
noncompliant behavior. Thus, in civil money penalty cases,
whether deficiencies pose immediate jeopardy, or are
widespread and cause actual harm that is not immediate
jeopardy, or are widespread and have a potential for more
than minimal harm that is not immediate jeopardy does not
reflect that a precise point of noncompliance has occurred,
but rather that a range of noncompliance has occurred which
may vary from facility to facility. While we understand the
desire of those who seek the greatest possible consistency in
survey findings, an objective that we share, the answer does
not lie in designing yardsticks of compliance that can be
reduced to rigid and objectively calculated numbers. Survey

team members and their supervisors ought to have some
degree of flexibility, and deference, in applying their
expertise in working with these less than perfectly precise

concepts. For these reasons,

we have revised the

regulations to require an administrative law judge or
appellate administrative review authority to uphold State
or HCFA findings on the seriousness of facility
deficiencies in civil money penalty cases unless they are

clearly erroneous.

59 Fed. Reg. at 56,179 (emphasis added). It is clear from this regulatory history that the
drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination

the clearly erroneous standard of review. T!
and other decisions that have mentioned de

that imposed by adoption of the clearly erro:
immediate jeopardy determination be given

would significantly limit the review of the

the drafters of the regulation.

In the foregoing quotation from Mississippi

that there was immediate jeopardy would receive deferential consideration, by adopting

us, caution must be exercised to ensure that

the Board’s decision in Mississippi Care Ctr. of Greenville, Daughters of Miriam Ctr.,

erence relative to immediate jeopardy not be

read to require deference for the determination that there was immediate jeopardy beyond

neous standard. Giving or requiring that the
deference in addition to applying the “clearly

erroneous standard” would be contrary to the intent of the drafters of the regulation;

letermination by an ALJ and the Board; and

would impermissibly deny an affected party the due process right to review intended by

Care Ctr. of Greenville, that panel of the

Board states that the clearly erroneous standard means that “the immediate jeopardy
43

determination is presumed to be correct, and the burden of proving the determination
clearly erroneous is a heavy one.” Jd. at 14. Similar formulations have been used in
other Board decisions when referring to the “clearly erroneous standard.” However, the
Board’s characterization of the “clearly erroneous standard” in Mississippi Care Ctr. and
other cases does not define the standard. The “‘clearly-erroneous standard” is described in
Black’s Law Dictionary as a standard of appellate review applied in judging the trial
court’s treatment of factual issues, under which a factual determination is upheld unless
the appellate court has the firm conviction that an error was committed. Black’s Law
Dictionary 269 (18th ed. 2004). The Supreme Court has addressed the “clearly erroneous
standard” in the context of the Administrative Procedures Act (APA). The Court
described the preponderance of the evidence standard, the most common standard, as
requiring that the trier of fact believe that the existence of a fact is more probable than not
before finding in favor of the party that had the burden to persuade the judge of the fact’s
existence. In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe and Products of
California, Inc. v. Construction Laborers, 508 U.S. 602, 622 (1993). The “substantial
evidence” standard considers whether a reasonable mind might accept a particular
evidentiary record as adequate to support a conclusion. Consolidated Edison, 305 U.S.
197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999). Under the “clearly
erroneous” standard a finding is clearly erroneous even though there may be some
evidence to support it if, based on all the evidence, the reviewing judge or authority has a
definite and firm conviction that an error has been committed. United States v. United
States Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete
Pipe, 508 U.S. at 622. The clearly erroneous standard has been characterized by the
Court as being stricter than the substantial evidence test and significantly deferential.
The Court stressed in discussing the clearly erroneous standard the importance of not
simply rubber-stamping agency fact-finding. The Court also commented that the APA
requires meaningful review. Dickinson, 527 U.S. at 162 (citations omitted); Concrete
Pipe and Products of California, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of
the immediate jeopardy issue. A finding of immediate jeopardy does not require a
finding of actual harm, only a likelihood of serious harm. Dumas Nursing and

4 The Board’s characterization of the clearly erroneous standard as being highly
deferential to the fact finding by the state agency surveyor and CMS and even triggering
a rebuttal presumption is entirely consistent with the Supreme Court’s characterization of
the standard. However, the Court’s cautions about ensuring meaningful review rather
than rubber-stamping agency decisions shows it is important for the ALJ and the Board
not to be tempted to simply defer to the surveyor, the state agency, or CMS on the
immediate jeopardy issue.

44

Rehabilitation, L.P., DAB No. 2347, at 19 (2010), citing Life Care Center of Tullahoma,
DAB No. 2304, at 58 (2010), aff'd, Life Care Center of Tullahoma v. Sebelius, No. 10-
3465 (6th Cir., Dec. 16, 2011). The definition of immediate jeopardy at 42 C.F.R. §
488.301, does not define “likelihood” or establish any temporal parameters for potential
harm. Agape Rehabilitation of Rock Hill, DAB No. 2411, at 18-19 (2011). The duration
of the period of immediate jeopardy is also subject to the clearly erroneous standard.
Brian Ctr. Health and Rehab./Goldsboro, DAB No. 2336, at 7-8 (2010). There is a
difference between “likelihood” as required by the definition of immediate jeopardy and
a mere potential. The synonym for likely is probable, which suggest a greater degree of
probability that an event will occur than suggested by such terms as possible or potential.
Daughters of Miriam Ctr., DAB No. 2067 at 10. Jeopardy generally means danger,
hazard, or peril. The focus of the immediate jeopardy determination is how imminent the
danger appears and how serious the potential consequences. Woodstock Care Ctr., DAB
No. 1726 (2000).

What is the meaning of serious injury, harm, or impairment as used in the definition of
immediate jeopardy found in 42 C.F.R. § 488.301? How does serious injury, harm,
impairment compare with “actual harm?” On the first question the Board recognized in
Yakima Valley School, DAB No. 2422, at 7 (2011), that the regulations do not define or
explain the meaning of the term “serious” as used in the definition of immediate
jeopardy.” The Board suggested that the definitions may be unimportant as the Board
has held that under the clearly erroneous standard that once the state agency or CMS
declares immediate jeopardy, there is a presumption that the actual or threatened harm
was serious and the facility can only rebut the presumption of immediate jeopardy by
showing that the harm or threatened harm meets no reasonable definition of the term
“serious.” Id., citing Daughters of Miriam Ctr., DAB No. 2067, at 9. In Daughters of
Miriam Ctr, the Board discussed that the ALJ attempted to define “serious” finding
meanings such as dangerous grave, grievous, or life-threatening. The Board notes that

5 Appendix Q of the State Operations Manual (SOM) also fails to provide surveyors a
working definition of the term “serious” that they can use to determine whether harm,
injury, or impairment is serious when deciding whether or not to declare immediate
jeopardy. The Act does not define the phrase immediately jeopardize as previously
discussed in this decision and does not introduce the concept of serious harm, injury, or
impairment as the basis for finding immediate jeopardy. Thus, one is not in error
concluding that absent a definition of the term “serious” in the Act, the regulations, the
SOM, or decisions of the Board, it is essentially up to individual surveyors and whatever
unpublished guidance they receive from their superiors or CMS officials, to exercise their
individual discretion and judgment to decide that there was immediate jeopardy, which
subjects a facility to the maximum imposable CMPs.
45

the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or
having lasting consequences. The Board further noted that the ALJ stated that a serious
injury may require hospitalization, or result in long-term impairment, or cause severe
pain as opposed to harm, injury, or impairment that is temporary, easily reversible with
ordinary care, does not cause a period of incapacitation, heal without special medical
intervention, or does not cause severe pain. The Board did not endorse or adopt the
ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of
that case. The Board reasoned, as already noted, that the facility bore the burden to rebut
the presumption by showing that the actual or threatened harm met no reasonable
definition of serious. Daugthers of Miriam Ctr., DAB No. 2067, at 9.

Applying the clearly erroneous standard to the record before me related to the
noncompliance I have found based on the violation of 42 C.F.R. § 483.25 (Tag F309), I
have a definite and firm conviction that the declaration of immediate jeopardy was in
error. My conclusion is based on my finding that while the evidence does show actual
harm in the form of pain or mental distress, the evidence does not show actual serious
harm, injury, or impairment or death, or a likelihood of serious harm, injury, or
impairment or death.

Surveyor Lubick alleged in the SOD that:

Petitioner did not adequately or consistently:

e Assess Resident 3 when she repeatedly moaned and
cried out in pain during rest periods and activity
(transfers, eating)

e Provide prescribed medications prior to transfers and
cares to promote comfort;

e Assess the effectiveness of its pain treatment regimen;

e Assess if pain was a contributing factor for the
increased anxiety, behaviors, constipation, significant
weight loss and skin breakdown that Resident 3 was
experiencing;

e Review the frequency of the need of prn (as needed)
pain medications for breakthrough pain.

As a result, Resident 3 experienced frequent episodes of pain
that were unresolved by pain medications.

The above failures created an Immediate Jeopardy situation
which began on 6/4/07.

CMS Ex. 13, at 55. Resident 3’s diagnoses on admission on January 20, 2007, included
psychological pain disorder, myofascial pain, and osteoarthritis. CMS Ex. 27, at 1-2, 7;
46

P. Ex. 1, at 1, 170. On admission, Resident 3 was assessed as complaining of
excruciating pain that was assessed to be soft-tissue pain. CMS Ex. 27, at 5-9. The MDS
indicates that she asked repetitive questions; voiced repetitive anxious complaints or
concerns; and displayed a sad, pained, worried facial expression on a daily basis. She
was also noted to withdraw from activities and to have reduced social interactions. CMS
Ex. 27, at 5-6; P. Ex. 1, at 168-69. Pain assessments by Petitioner’s staff show that the
resident suffered pain. A pain assessment form dated January 20, 2007, indicates that
Resident 3 had generalized pain characterized as a dull ache in all joints due to
osteoarthritis and myofascial pain. The severity of her pain is not indicated but an
acceptable level of pain is marked as three on a scale of one to ten, with ten being worst.
Medications indicated for pain are Celebrex (a nonsteroidal anti-inflammatory drug
(NSAID)) and Darvocet (Acetaminophen and a narcotic). CMS Ex. 27, at 164; P. Ex. 1,
at 217. The resident was assessed for pain and received pain medications. CMS Ex. 27,
at 164-232. A care plan dated February 1, 2007, addressed Resident 3’s diagnosis of
arthritis with approaches of assessing the resident’s pain every shift and as necessary;
administering Tylenol (Acetaminophen) as ordered; and observing her for non-verbal
pain indicators, with the goals of the resident being pain free or at an acceptable level of
pain and able to participate in ADLs without pain. CMS Ex. 27, at 153; P. Ex. 1, at 266.

A pain assessment dated April 15, 2007, describes Resident 3 as having chronic,
generalized joint pain due to osteoarthritis, which was worse in the morning. Non-verbal
indicators that Resident 3 was experiencing pain were guarding and grimacing. The form
indicates that Resident 3 was unable to respond to the question of what level of pain was
acceptable, but a note indicates that the resident denied discomfort or pain. APAP
(Acetaminophen) 500 mg is listed as the medication used. CMS Ex. 27, at 166; P. Ex. 1,
at 215. The April 2007 MDS assessed Resident 3 as complaining of periods of mild pain
occurring less than daily. The April 2007 MDS shows that she continued to withdraw
from activities and to have reduced social interaction but there was no indication of
repetitive questions, anxious complaints or concerns, or a sad and pained expression.
CMS Ex. 27, at 14-16; P. Ex. 1, at 162-63. A Care Conference Checklist dated April 24,
2007, indicates that the resident should be repositioned as needed for pain and that the
resident seemed more awake due to reduction of her psychotropic medication. P. Ex. 1,
at 256. Thus, the evidence shows improvement of the resident’s pain and pain control as
of April 2007.

The clinical record, though inconsistent in the reporting of instances of pain and
behaviors and incomplete in recording the effectiveness of interventions, shows that
Resident 3 obtained relief of pain from medication and non-pharmacological
interventions. Resident 3’s MAR for April and May 2007 show that she received a daily
dose of Acetaminophen, two tablets of 500 milligrams once a day for arthritis, however
the order was discontinued on May 30, 2007. P. Ex. 1, at 328, 340, 356. Nurse’s Notes
and 24-Hour Reports for April 2007 show that Resident 3 complained of a headache on
April 6, leg pain on April 7, leg pain on April 9, and leg pain and bilateral ankle pain on
47

April 12, 2007. The report shows that each complaint of pain in April 2007 was
addressed with Tylenol with relief of the pain. P. Ex. 6, at 1-6, 133-34. Nurse’s Notes
record a complaint of bilateral foot pain on April 30, 2007. P. Ex. 1, at 135. Nurse’s
Medication Notes for April 2007, show that Resident 3 was given Tylenol or
Acetaminophen ten times on seven days, April 6, 9, 11, 18, 26, 29, and 30, 2007, for
headache, leg, ankle, or foot pain. There is no indication of whether or not the pain
medication was effective in three instances but entries show it was effective in six
instances and ineffective in one instance with no indication other interventions were
attempted. P. Ex. 1, at 355. A MAR for April 2007 lists Acetaminophen for pain as
needed every four hours and shows administration on April 6, 7, 9, 11, 12, twice on 13,
twice on 19, 28, and 30. P. Ex. 1, at 354. A pain assessment flow sheet for May 2007,
records complaints of pain on ten days (11 instances), eight days the pain was in her legs,
one day she was unable to state where the pain was, and one day just has a question mark.
The indicators of pain are verbalization on one occasion, verbalization and moaning on
four occasions, moaning on two occasions, moaning and yelling on two occasions, and
moaning and crying on two occasions. She was given Tylenol or the generic
Acetaminophen seven times, Vicodin four times, and a Tylenol and Vicodin on one
occasion. Non-medication interventions listed are repositioning, rest, one-on-one time,
and fluid. Six events are noted to have resulted in decreased moaning, quiet, or the
resident was asleep after interventions. However, five events do not indicate whether the
interventions were successful. CMS Ex. 27, at 222; P. Ex. 1, at 136-38, 346. A Nurse’s
Medication Notes form for May 2007 shows that Acetaminophen was administered on
May 1, 2, and 8 for moaning and complaints of leg pain and that the medication was
effective. Vicodin was administered on May 23, 27, and 28 for moaning and yelling and
complaints of leg pain, and the drug was noted to be effective in one instance but there
was no note for the other two instances. P. Ex. 1, at 349. A MAR for May 2007 shows
Acetaminophen prescribed to be administered as needed for pain was given on May 1, 2,
3, 21, 23, and 28 and Vicodin was given on May 23, 27, and 30. P. Ex. 1, at 348. A 24-
Hour Report entry on May 21, 2007, contains the request that something be ordered for
Resident 3’s pain as she had only Tylenol 500 mg and that was not enough. The report
indicates that the morning nurse called but the afternoon nurse noted that no call-back
was received. P. Ex. 6, at 14. A 24-Hour Report entry from the night-shift on May 22,
2007, reflects that Resident 3 was “crying out all night” and there was no call back from
the physician. CMS Ex. 6, at 15 (emphasis in original). However, an entry from the day-
shift indicates a new order for Vicodin, half-tablet by mouth every six hours as needed
for pain. CMS Ex. 6, at 15. Entries on the 24-Hour Report on May 28 and June 3, 2007
show that she was given Tylenol and Vicodin for complaints of leg pain and leg cramps.
An entry on June 4, 2007, indicates that the resident was crying out all night and she was
given Vicodin; a day-shift note indicates that she cried out with any movement and that
her left shoulder, arm, hip, and leg would be x-rayed to rule out fractures. A note from
the second-shift indicates that the left hip was x-rayed and that the power of attorney
wanted Resident 3’s Clonazepam increased. P. Ex. 6, at 19. Entries in the 24-Hour
Report forms continue to show that Resident 3 was moaning loudly and/or crying on June

48

5, 6, 7, and 14, 2007. The notes reflect that on June 7 she complained specifically of leg
pain and was holding her right inner thigh and she was sent to the hospital for x-rays of
the right hip, which were negative. P. Ex. 6, at 20-25.

Nurse’s Notes are consistent with the 24-Hour Reports. P. Ex. 6, at 138-43. The Nurse’s
Notes record that on June 5, 2007, the physician increased Resident 3’s Clonazepam back
to its prior dose. On June 6, 2007, a new order for an increased dose of Vicodin was
obtained to address the resident’s increased moaning. A note dated June 14, 2007 records
that the physician was updated that Resident 3 continues to call-out despite increased
Vicodin, sometimes verbalizing pain and sometimes not. P. Ex. 1, at 139. An Analgesic
Record/Pain Flow Sheet for June 2007 reflects complaints of leg pain on June 1, 2, 4, and
6; a complaint of shoulder pain on June 10; complaints of pain on June 9 and 11, the
location of which could not be determined. The form shows that Resident 3 was given

er scheduled Hydrocodone or a half-tablet of Vicodin with evidence of pain relief in

four instances but no notation of whether the medication was effective in four instances.
CMS Ex. 27, at 231; P. Ex. 1, at 332. A Nurse’s Medication Notes form shows that
Hydrocodone was administered on June 1, 2, 3, 5, and 6 for moaning and/or crying rather
than pain; with the notation on June 3 and 6 that the medication was not helpful; but no
indication of effectiveness on June 1, 2, and 5. P. Ex. 1, at 331. Resident 3’s MAR for
June 2007 indicates that the Hydrocodone could be given every six hours as needed for
pain, with entries showing administration on June 1, 2, 3, 4, 5, 6, and 9, 2007. P. Ex. 1, at
330. Nurses’ Progress Note forms for April and May 2007 do not include any discussion
of Resident 3’s complaints of pain. The June 2007 Nurses’ Progress Note lists a new
order for Vicodin by mouth every six hours on a routine basis for pain and also notes that
staff was awaiting results of a second set of x-rays. P. Ex. 1, at 125-30.

A follow-up/quarterly assessment summary dated June 12, 2007, indicates that Resident
3 had increased complaints of discomfort and pain at different times in different areas.
CMS Ex. 27, at 167; P. Ex. 1, at 216. Resident 3’s care plan was updated on June 6,
2007, with the intervention to use Vicodin (Acetaminophen and the narcotic
Hydrocodone) as necessary if pain is severe. A Pain Assessment form dated June 15,
2007 indicates that the resident was unable to assess the severity of her pain but she was
crying. The narrative indicates that when the resident was approached she started crying
out and when asked if she hurt, she responded that she wished she did. The note
indicates that Resident 3 calls out with any interaction and sometimes when no one is
present. The note states that both staff and the physician are monitoring closely and that
pain and psychotropic medications are being adjusted to address progressing dementia
and “failed dose reduction.” P. Ex. 1, at 188-89. The care plan was updated on June 15,
2007, with the intervention to administer narcotics as ordered. CMS Ex. 27, at 153; P.
Ex. 1, at 266.

The foregoing clinical evidence from January 2007 to the survey in June 2007 shows that
Petitioner’s care planning, assessment, and treatment of Resident 3’s pain was not

49

perfect. However, the clinical evidence shows that the resident was repeatedly assessed
for pain, alternative interventions including increasingly significant pain medications
were implemented, the effect of interventions was assessed and recorded, there was a
period of improved pain control, the resident’s treating physician was actively involved
in care planning and treatment, and psychiatric consults were ordered and performed.

Dr. Kraus testified that Resident 3’s case was complicated in the last few months and that
he or his physician assistant called facility staff daily to follow the resident’s case. Tr. at
435-41. He testified that due to the resident’s reduced ability to communicate it was
difficult to determine whether her agitation was due to pain or her dementia. Testing and
examination was done to attempt to determine a source for pain but there was no trauma
or change in physical condition that explained her increased complaints of pain. Tr. at
459-63. He opined that the resident was treated consistent with the standard of care and
there was no risk for serious harm or injury or death and there was no potential for more
than minimal harm. Tr. at 470-71. Dr. Kraus’s opinion that there was no risk for more
than minimal harm is consistent with his diagnosis that there was no cause for the
resident’s complaints of pain. I have discounted that opinion as the clinical evidence
shows that the resident complained of pain whether or not due to physical or
psychological causes. However, Dr. Kraus’s opinion that there was no risk for serious
harm, injury, or death is consistent with his knowledge of the resident’s condition, his
regular care of the resident, and the clinical evidence discussed above which shows that
there was care planning and interventions to minimize potential pain.

Surveyor Lubick testified to observing Resident 3 on June 12, 2007, when she was
yelling she was cold and when prompted by the CNA, the resident said she had back
pain. Surveyor Lubick testified to no other signs and symptoms of pain but concluded
that the resident was suffering from unresolved pain. Tr. at 45-47. I infer the resident
was not suffering from severe pain as she only complained when the CNA asked if she
had pain. Surveyor Lubick again observed the resident approximately three hours later
on June 12, and the resident was moaning and calling out very loudly. She testified she
asked Resident 3 what was the matter and the resident replied that her legs were breaking.
Tr. at 47. Survey Lubick testified she told a staff member who advised her that the
resident was on scheduled pain medication, which was being adjusted. Surveyor Lubick
opined that staff should have assessed the resident and used available pain medication or
other interventions. Tr. at 47-49. Surveyor Lubick is correct that the staff member
should have responded to Surveyor Lubick’s concern by assessing the resident and then
making an informed judgment about whether some intervention was appropriate rather
than dismissing the surveyor as she did. However, I recognize, as no doubt the staff
member did, that Resident 3’s complaint was exaggerated. Clearly, the resident’s legs
were not breaking and she was regularly being given pain medication for her complaints
of pain. Surveyor Lubick next saw the resident during the morning on June 13, this is the
incident discussed under Tag F224, which I inferred was behavioral and not related to
pain and which caused me to conclude that Surveyor Lubick’s opinion as to the existence

50

of pain and its severity was not weighty. On June 14, 2007, Surveyor Lubick observed
the resident yelling loudly that her legs hurt while staff was providing care. The staff
member consulted with a nurse and was told that the resident had been given a dose of
Vicodin approximately two hours before and the nurse instructed the staff member to get
the resident up and she would be in to speak to her. Surveyor Lubick did not dispute that
the resident received Vicodin two hours in advance of the incident or opine that the
Vicodin was inadequate for pain control in advance of care. Rather, Surveyor Lubick
opined that the nurse should have assessed the resident. Tr. at 54-55. Again I agree with
Surveyor Lubick that the nurse should have personally assessed the resident rather than
simply relying upon the report of the CNA, her knowledge that the resident had received
Vicodin, and her knowledge of the resident. Surveyor Lubick observed Resident 3
approximately 25 minutes later when staff was lifting the resident out of bed and moving
her to the bathroom with a mechanical lift. Resident 3 was screaming or yelling. The
DON ordered staff to stop and the resident was given another half Vicodin. Surveyor
Lubick opined that the resident had been crying out for half an hour. Tr. at 55-56. The
extra half of a Vicodin tablet was not effective to stop the resident’s yelling as a nurse’s
note for June 14, 2007, at 8:40 a.m. shows that the physician had to be contacted for
additional instructions and new orders.*° CMS Ex. 27, at 57, 131. The evidence does not
show that Surveyor Lubick did not observe the resident in pain. Rather, the evidence
shows that when the resident’s complaints of pain were not resolved, Petitioner’s staff
consulted with the treating physician to determine the appropriate treatment. Rather than
simply sedate the resident with higher doses of pain or psychotropic medications during a
time when staff and physician were working to assess the cause of the complaints, the
care planning team continued to work to find the best treatment modality. Selection of
the best treatment modality in this complicated case was a matter for the treating
physician and Petitioner’s staff, not the surveyor, the state agency, CMS, or me. While it
is more likely than not that the resident experienced some pain as Surveyor Lubick

°° The Nurse’s Notes entry for June 14, 2007 at 8:40 a.m. shows that Dr. Kraus was
advised that Resident 3 continued to call-out despite scheduled Vicodin; she called-out
when no one was around; and she called-out with any movement. Sometimes the
resident complained of pain and sometimes she denied pain. The note indicates that Dr.
Kraus gave new orders and that Petitioner’s staff was waiting for the psychiatric consult
notes to send to him. CMS Ex. 27, at 131. The new orders received on June 14, 2007 at
8:40 a.m. were for 10 milligrams of Oxycontin by mouth every 12 hours for pain; an
additional 5 milligrams of Oxycontin by mouth every six hours as needed for
breakthrough pain; and to increase the residents Seroquel to 50 milligrams to address her
agitation related to Alzheimer’s. CMS Ex. 27, at 57. This evidence supports Dr. Kraus
testimony regarding on-going efforts to evaluate the cause of the resident’s complaints
and behaviors and to adjust medication appropriately.
51

concluded, I have a firm conviction based upon the contemporaneous medical evidence
and the testimony of the treating physician, Dr. Kraus, that the resident’s pain was not
actual or potential harm that met any reasonable definition of serious harm, injury, or
impairment, or that was likely to cause her death. Common definitions, synonyms for
serious and related words found at oxforddictionaries.com, merriam-webster.com, and
dictionary.com, respectively, are: significant or worrying because of possible danger or
risk; having important or grave possible consequences, grave, severe; and dangerous,
grave, severe, life-threatening, grievous.

The CMS expert witness, Dr. Berlowitz, opined that Resident 3 did not receive the
necessary care and services to be as free of pain as possible. He testified that the clinical
record shows the resident had chronic pain that required narcotic therapy to relieve the
pain. He testified that the record shows that Resident 3 specifically stated that she was in
pain on numerous occasions. Her treatment was limited to Tylenol until May and he
opined that she should have been started on stronger medication sooner. He testified that
systematic monitoring of the pain and the effect of pain medication is not reflected in the
clinical record and that monitoring should have been done. He testified that using
Tylenol, then escalating to narcotics as needed, and then to scheduled narcotics was fine,
but there was an unduly long time in the transition to the stronger medication which he
attributed to the absence of adequate monitoring of the resident’s pain and the
effectiveness of the medication. He testified that pain has both physical and
psychological components and the fact that she was diagnosed with a chronic pain
syndrome does not mean she did not have real pain. The fact she had pain is reflected by
the fact that she had some relief from pain medication. Dr. Berlowitz opined that pain is
serious harm and that there was no need for someone on comfort care measures such as
Resident 3 to be in pain. Tr. at 350-58; CMS Ex. 80, at 2. Dr. Berlowitz is without a
doubt an expert in geriatric medicine. In weighing his opinions, however, it is important
to recognize that his knowledge of Resident 3 was based upon his review of the clinical
records and not upon any examination of the resident. His opinion that Resident 3 was
not as free of pain as possible is worthy of weight and consistent with my conclusion that
the resident did suffer actual harm in the form of pain. His opinion that the resident could
have been advanced to narcotic pain medication sooner is clearly correct. However, the
decision to increase medication is a medical decision that is best left to the judgment of
the treating physician who has been examining the resident and treating the resident and
is more familiar with the resident’s case, including the care plan and goals. The clinical
evidence shows improvement of the resident’s complaints of pain and pain symptoms in
April 2007. Tr. at 415. The clinical evidence shows that the resident continued to
receive relief from pain through the use of non-narcotics in the first half of May. The
evidence shows that the resident did not require medication on a daily basis. The
resident’s pain was clearly monitored and assessed as reflected by the clinical evidence,
though the documentation of assessment and monitoring was not perfect. Therefore, Dr.
Kraus’s judgment not to advance to narcotics earlier than he did has some support in the
clinical evidence. I do not find that Dr. Berlowitz’s opinion that Resident 3’s pain

52

amounted to serious harm merits any weight. Dr. Berlowitz was not asked to clarify and
did not offer any characterization, definition, or description for what he considered to be
“serious harm.” Rather, Dr. Berlowitz simply said that in his opinion there was no need
for a person on comfort care to experience any pain. He testified “based on the
surveyor’s notes” that the resident’s complaints of pain were often ignored. Tr. at 354,
415. The clinical evidence and even the surveyor’s testimony and notes do not support
is conclusion that the resident’s complaints of pain were often ignored or that she was
not given pain medications in advance of cares. The evidence shows that the resident’s
complaints were assessed and addressed in most instances and that she did receive pain
medication on a scheduled and as needed basis.

Dr. Kurt Hansen, Petitioner’s expert, opined that the treatment of Resident 3’s pain was
consistent with standards of practice. He opined that her moaning was related to
agitation and behavioral problems secondary to dementia rather than pain. He testified
that the resident’s primary care physician and a consulting psychiatrist were addressing
er symptoms, there were multiple medication changes to address behavioral symptoms,
x-rays were done, psychotropic medications were used, and pain medication was
increased. He opined that the fact increased pain medication did not stop the resident’s
moaning supports his conclusion that the moaning was not the result of pain. He opined
that the resident’s mild osteoarthritis would not cause pain consistent with the resident’s
behaviors rather the osteoarthritis would have caused pain with movement but the
resident would cry-out whether moving or not. He opined that Petitioner’s care plan was
appropriate and not likely to cause serious injury, harm, death, or more than minimal
arm. Tr. at 679-85. Dr. Hansen testified on cross-examination that he did not know
what problems the resident was having with pain prior to her admission to Petitioner. Tr.
at 734. He agreed that he could not rule out that the resident’s moaning and crying out
was due to pain rather than agitation. Tr. at 735-36. Dr. Hansen’s opinion that Resident
3 was receiving care consistent with the standard of practice is entitled to weight. His
opinion is consistent with and supported by the clinical evidence. His opinion that the
resident’s moaning was likely not caused by pain, at least in some instances, is consistent
with the fact that the moaning was not resolved by significant pain medication in some
instances. However, he also acknowledged that the resident’s osteoarthritis could cause
some pain with movement. Dr. Hansen was also not asked to elaborate upon his
understanding of the phrase “‘severe injury or harm” in the context of immediate jeopardy
and that opinion is no more or less weighty than Dr. Berlowitz’s opinion on the same
topic.

Weighing the opinions of the treating physician, Dr. Kraus, against those of the CMS
expert, Dr. Berlowitz, I conclude that the opinions of Dr. Kraus should be given greater
weight in determining the seriousness of the potential harm, injury, or impairment to
Resident 3. Dr. Berlowitz, never clearly articulated how he defined “serious harm”
though his testimony indicated that in his opinion any pain was both serious and
unnecessary in the case of Resident 3. Dr. Kraus was the treating physician for Resident
53

3 for approximately six months prior to the survey, the evidence shows he or his
physician’s assistant regularly saw her, that he was regularly updated by Petitioner’s staff
and that he was actively involved in the care and treatment of the resident. Based on his

nowledge of the resident it was not unreasonable for him to conclude that the resident’s

complaints of pain were exaggerated, possibly due to psychiatric causes such as dementia
rather than a physical cause. It was not unreasonable, given the clinical record, for the
physician to determine it was appropriate to permit some complaints of pain while
attempting to adjust interventions rather than to simply sedate the resident to prevent her

complaints. Dr. Kraus’s testimony supports my conclusion that Resident 3 was receiving
sufficient care and treatment that there was no probability or likelihood that unresolved
pain had the potential to cause serious harm, injury, impairment, or death.

Surveyor Lubick alleged in the SOD that Resident 3 experienced frequent episodes o
pain that were unresolved by pain medication, due to Petitioner’s failure to: assess the
resident when she moaned and cried out; provide prescribed medication prior to transfers
and cares; assess effectiveness of pain treatment regimen; and review the effectiveness of
medication for her breakthrough pain. Surveyor Lubick alleged that these failures posed
immediate jeopardy, i.e., a potential for serious harm, injury, impairment, or death. CMS
Ex. 13, at 55, 72. I have a definite and firm conviction that the declaration of immediate
jeopardy was in error in this case. My conclusion is based on my finding that while the
evidence does show actual harm in the form of pain or mental distress, the evidence does
not show actual serious harm, injury, or impairment or death or a likelihood of serious
arm, injury, or impairment or death. The clinical record and the testimony of Dr. Kraus
show that the resident received treatment for pain; was frequently assessed; and closely
monitored. The evidence shows that the resident’s complaints of pain likely involved
both a physical and a psychiatric cause. Based on the contemporaneous clinical records,
pain was not resolved in some instances by significant pain medication supporting an
inference that the complaints of pain were not due to a physical cause. The records show
that in other instances complaints of pain were resolved by more mild analgesics or even
distracters such as cookies, indicating that pain was physical but not as significant as the
surveyor and CMS argue. Most importantly, the clinical record shows that the care
planning team, including Dr. Kraus, was actively involved in the care of Resident 3. The
records are not perfect, the assessments not as frequent or thorough as Surveyor Lubick
and CMS might prefer, and narcotics were not implemented as early as Dr. Berlowitz
would have had Resident 3 been his patient. Nevertheless, I am convinced that it was not
likely or probable that Resident 3 was going to suffer serious harm, injury, impairment or

54

death.” Accordingly, I conclude that the declaration of immediate jeopardy was clearly
erroneous.

The Board expressed concern that I did not address whether the bases alleged for
immediate jeopardy under Tag F309 had the potential for causing serious injury, harm,
impairment, or death to any other resident. Columbus Nursing and Rehab. Ctr., DAB
No. 2398, at 9-10. Surveyor Lubick stated in the SOD that she considered five other
residents related to the delivery of care and services for pain. CMS Ex. 13, at 55.
Surveyor Lubick did not specifically allege that any of the other five residents were in
immediate jeopardy. She did not allege facts, specifically or generally, that suggest that
the declaration of immediate jeopardy extended to other residents in Petitioner’s facility.
CMS Ex. 13, at 54-72. Surveyor Lubick stated that immediate jeopardy was abated on
June 14, 2007, at which time Petitioner had reviewed the case of all residents with
scheduled pain medication using Petitioner’s current assessment tool; staff had been
instructed to call the nurse if a resident seemed to be experiencing significant pain; and
physicians would be adjusting pain management regimens as necessary. CMS Ex. 13, at
72. Surveyor Lubick does not indicted that any of the interventions implemented to abate
immediate jeopardy were new or not already standard practice in Petitioner’s facility.
Rather, the assessment of the residents using the current pain assessment tool was a
method for Surveyor Lubick to confirm that there were no deficiencies related to other

°7 The Board noted that on appeal CMS argued that Resident 3’s pain contributed to
other serious consequences. The Board specifically noted the argument related to
pressure sores and weight loss. The Board failed to mention that CMS advanced the
argument related to pressure sores and weight loss without the benefit of supporting
evidence. Columbus Nursing and Rehab. Ctr., DAB No. 2398, at 9 n.4. Not even
Surveyor Lubick alleged that unresolved pain caused or was a contributing factor to
weight loss or pressure sores. Rather, Surveyor Lubick alleged that Petitioner failed to
assess and attempt to determine whether the resident’s pain was a contributing factor.
The Board affirmed my Conclusions of Law 5 through 8 that there was noncompliance
related to pressure ulcers and weight loss that amounted to immediate jeopardy. I see no
legal need to engage in an analysis of whether the resident’s pain may have been a
contributing factor to weight loss or the development pressure ulcers, particularly where
there is no evidence urged by CMS as supporting the argument and given that I have
already concluded that there was immediate jeopardy related to the actual weight loss and
the development of pressure sores. I also conclude that it is not necessary given the
posture of this case to determine whether there was any colorable basis for the CMS
argument or whether it was frivolous. CMS made the argument to the Board and not to
me and I will not exercise my jurisdiction to inquire as to a potential offense to the Board
absent some specific direction by the Board to do so.

55

residents. The instruction to staff to call the nurse and the reminder that physicians
would adjust pain management approaches are simply reminders to staff. Even if
Surveyor Lubick had alleged that immediate jeopardy extended to other residents, I
would have a definite and firm conviction that the declaration of immediate jeopardy was
in error based upon Surveyor Lubick’s lack of objectivity demonstrated in the example of
Resident 3.”

5. Petitioner violated 42 C.F.R. § 483.25(c), Tag F314, as alleged by the
survey completed on June 27, 2007 (Affirmed).

6. The determination that Petitioner’s violation of 42 C.F.R. §
483.25(c) posed immediate jeopardy was not clearly erroneous
(Affirmed).

The quality of care regulation includes the requirement that a facility ensure that a
resident who enters the facility without a pressure sore does not develop one unless
clinically unavoidable, and that a resident entering with a pressure sore receives care and
services necessary for healing, to prevent infection, and to prevent other sores from
developing. 42 C.F.R. § 483.25(c). CMS has adopted definitions for terms related to the
regulation that are to be applied by surveyors in conducting surveys. A “pressure sore,”
often referred to as a “pressure ulcer,” is any lesion of the skin caused by unrelieved
pressure that damages the underlying tissue. “Friction” is the mechanical force exerted
on skin that is dragged across any surface. “Shearing” results when layers of the skin rub
against each other or the underlying tissue rubs against the skin resulting in tissue
damage. Friction and shearing are not primary causes of pressure ulcers but they are

°8 The Board directed that I address whether or not CMS gave timely and adequate
notice that it alleged that Resident 3 suffered “severe” pain. Columbus Nursing and
Rehab. Ctr., DAB No. 2398, at 9n 4. It is clear from the regulations and the prior
decisions of the Board that the fact issue to be resolved in addressing immediate jeopardy
is whether there is actual or a potential for “serious” harm, “serious” injury, or “serious”
impairment. Petitioner had sufficient notice based on the SOD that CMS alleged that
there was a potential for serious harm, injury, or impairment to Resident 3 or that
Resident 3 had suffered serious harm, injury, or impairment related to the noncompliance
alleged under Tag F309. The Board, CMS, and Petitioner do not state what legal
significance if any the term “severe” has in context of Tag F309 or the allegation of
immediate jeopardy related thereto. To the extent “severe” may be viewed as meaning
“serious,” Petitioner had adequate notice. Otherwise, the term “severe” has no legal
significance and there is no requirement that I have found that requires CMS to give
notice prior to using a legally insignificant term to describe Resident 3’s pain.
56

considered to be contributing factors. “Eschar” is a thick, leathery, black or brown
colored, necrotic or devitalized tissue that has lost its normal physical properties and
biological activity and it may be loose or firmly adhered to a wound. SOM, App. PP,
Tag F314.

The application of the regulation is well-established by decisions of various appellate
panels of the Board. Koester Pavilion, DAB No. 1750 and Cross Creek Health Care
Ctr., DAB No. 1665 are leading decisions in this area. The Board has noted that the
pressure sore regulation contains two prongs: (1) a facility must ensure a resident who
enters the facility without sores does not develop sores unless the resident’s clinical
condition demonstrates that pressure sores are unavoidable; and (2) a resident with
pressure sores must receive necessary treatment and services to promote healing, prevent
infection and prevent new sores. With respect to prevention and treatment of pressure
sores, the Board has concluded that a facility bears a duty to “go beyond merely 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 Pavilion,
DAB No. 1750, at 32; see also Meadow Wood Nursing Home, DAB No. 1841 (2002)
(loose dressing contaminated with fecal matter constitutes violation); Ridge Terrace,
DAB No. 1834, at 15-16 (a single observation by a surveyor of a nurse aide cleaning an
open sore area with a stool-stained washcloth was sufficient to sustain a deficiency
finding under this Tag). Once CMS establishes a prima facie case, the facility bears the
burden of showing that the development or deterioration of a pressure sore was clinically
unavoidable.

An appellate panel of the Board in Clermont Nursing and Convalescent Ctr., DAB No.
1923, at 9-10 (2004), aff'd, Clermont Nursing and Convalescent Ctr. v. Leavitt, 142 Fed.
Appx. 900 (6th Cir. 2005), provided the following analysis:

The standard of necessity is expressly articulated in the
regulation. The primary regulatory requirement is that
residents must receive, and facilities must provide, “the
necessary care and services” for attainment or maintenance of
the highest practicable resident well-being. 42 C.F.R.

§ 483.25 (emphasis supplied). The regulation then goes on to
provide that a resident with pressure sores must receive
“necessary treatment and services” for healing, prevention of
infection, and prevention of yet more pressure sores. 42
C.F.R. § 483.25(c)(2) (emphasis supplied). We therefore
reject Clermont’s contention that the standard is “nowhere in
the regulation.” That argument is belied by the plain
language of the regulation.
57

Moreover, as we explained in Koester Pavilion, in the
preamble to the final regulation, CMS expressly declined to
use “less demanding” language with respect to a facility’s
obligation to “ensure” outcome of treatment for pressure
sores. Koester Pavilion at 30, quoting 56 Fed. Reg. 48,826, at
48,850 (Sept. 26, 1991). CMS recognized that factors beyond
required treatment and services, such as disease process and
resident compliance, affect care outcome. Jd. However,
CMS also recognized that the regulation allows a facility to
put forward “available clinical evidence” to show that “a
negative resident care outcome was unavoidable.” Jd. The
preamble further provides that facilities “should always
furnish the necessary treatment and services” for pressure
sore prevention or healing. Jd. at 30-31(emphasis supplied).
Thus, a facility may provide necessary treatment and services
to ensure the prevention or healing of pressure sores, yet still
be confronted with a negative outcome. In that instance, the
facility may put forward clinical evidence to show that the
outcome was unavoidable.

See also Woodland Vill. Nursing Ctr., DAB No. 2172, at 12-14 (2008).

The surveyors and CMS contend that Petitioner failed to render necessary treatment and
services to Resident 3 to prevent the development of pressure sores on both of Resident
3’s heels that were discovered April 28, 2007 and the pressure sore on Resident 3’s right
foot that was discovered on June 12, 2007. CMS Ex. 13, at 73-91. It is alleged that the
violation posed immediate jeopardy beginning on June 12, 2007; that the jeopardy was
abated on June 14, 2007; but that the deficiency continued as Petitioner had not
implemented its complete action plan.

A Nursing Admission Assessment of Resident 3 was completed upon her admission on
January 20, 2007, and documents a small Stage II decubitus ulcer on her coccyx. CMS
Ex. 27, at 270. A Resident Assessment Protocol (RAP) form dated February 2, 2007
assessed the resident as at risk for pressure ulcers due to her current ulcer on her coccyx,
impaired bed mobility, and incontinence. It was noted on the form that she had diagnoses
of dementia and osteoarthritis; that she was working with therapy to increase strength and
mobility; that she was at low risk for nutritional depletion; and that she would benefit
from toileting every two hours. P. Ex. 1, at 177. A Weekly Pressure Ulcer Progress
Report shows that the ulcer was healed by February 28, 2007, the form notes that there
was a risk for the ulcer to return due to incontinence of urine and there was an instruction
to use a barrier cream to help prevent a new ulcer. CMS Ex. 27, at 278; P. Ex. 1, at 243,
246, 527.
58

Resident 3’s initial care plan dated January 21, 2007, required that she be repositioned
every two hours and that a weekly skin assessment be done and recorded. The plan for
incontinence required that she be toileted every two hours or as necessary, that her
perineal area be assessed, and that a protective cream be applied. P. Ex. 1, at 593.
Resident 3’s care plan dated February 6, 2007, listed as problems small sores on the
resident’s buttocks. There is no evidence that the care plan was changed when the sores
on her buttocks were reported to be healed on February 28, 2007, contrary to the
argument of Petitioner (P. Reply at 7-8). The care plan also listed a problem dated April
28, 2007,”? as blisters on both heels had hardened and were turning to eschar. A problem
dated June 12, 2007 indicates an eschar on the right, fifth plantar surface. The individual
interventions listed on the care plan are generally not dated. The interventions include:
pad, protect, and/or apply skin preparation to fragile skin; position body with
pillows/support devices and protect bony prominences; apply cream after each episode of
incontinence, keep skin clean and dry, and perform peri-care after each incontinent
episode; pressure reduction to be used for sitting and there was a direction that therapy
review current type of pressure reduction which was noted not to be effective; staff was
to inspect her skin daily; licensed staff was to perform weekly skin assessments; and
weekly wound progress assessments and documentation were to be done, with treatment
as ordered. The intervention of a dietary referral to review nutrition is dated February 13,
2007. The intervention of a physical therapy referral for ankle flexion therapy, I infer
was related to the blisters discovered on the heels on April 28, 2007, which is consistent
with the intervention dated May 1, 2007 that required placing Thera-Boots on both feet
for protection. | also infer that the intervention of placing sheep skin padding between
the Thera-Boot and the right foot by the little toe relates to the eschar discovered on the
plantar surface of the right foot near the little toe on June 12, 2007. Although the care
plan includes the intervention of elevating heels off the bed, it was never checked and, I
infer, never planned or ordered. CMS Ex. 27, at 160; P. Ex. 1, at 258. Another care plan
that appears to address eating, nutrition, hydration, oral and dental care, and skin
condition with dates from February | to July 2007, includes the following interventions:
a cushion in the wheel chair for pressure relief (undated); weekly assessment of the skin

> Petitioner asserts that the mushy heels were actually discovered on April 23, 2007, but
concedes that the handwriting on the facility’s records could be read as either April 23 or
28, 2007. P. Brief at 6-7 (citing P. Ex. 1, at 247, 412). Petitioner’s argument reveals a
preference for April 23 in support of Petitioner’s argument that staff did not fail to doa
weekly skin assessment. However, if April 23 was the correct date there is no
explanation for a five day delay in updating the resident’s care plan to address the mushy
heels. My reading of Petitioner’s clinical record is that the mushy heels were discovered
on April 28, 2007.
59

with a report of any redness to the RN (undated); updating the MD as necessary
(undated); providing Thera-Boots (noted to be discontinued on an unreadable date in June
2007); and the use of an air mattress (June 15, 2007). P. Ex. 1, at 264. Petitioner also
submitted as evidence a form for the period May 1, 2007 through May 31, 2007, on
which staff recorded their initials to indicate that certain interventions were performed
each shift with the following interventions that do not appear on another care plan
document: skin barrier twice each day to both heels dated April 28, 2007; Thera-Boots
on at all times with checks every two hours dated April 28, 2007; and the undated
intervention to cover the right heel with telfa and to wrap with cling if drainage was
present. P. Ex. 1, at 338.

Petitioner provided copies of weekly wound assessments for February 6, 13, 20, 28, and
March 6, 13 and 20, 2007. The assessments show that the resident’s buttocks ulcers
ealed as of February 28, 2007. The wound nurse recommended that due to the
resident’s ongoing urinary incontinence, a barrier cream be used following incontinence
episodes. P. Ex. 1, at 245-46, 529-30. The next weekly wound assessment is dated a
month later on April 28, 2007, when it was discovered during a shower assessment (P.
Ex. 1, at 412) that the resident had bilateral spongy heels, with intact skin. The
assessment indicates that a skin barrier was applied, the Thera-Boots were initiated, and
the nurse would continue to monitor on the weekly wound assessment. The May 1
assessment shows that there was a problem with the fitting on the left boot that was
adjusted to fit without discomfort. Nevertheless, the nurse had the physician agree to a
physical therapy consult to address the resident’s dorsal flexion. In the May 8, 2007
assessment the nurse notes that the right heel is draining, that the staff continued to apply
the Thera-Boot with skin barrier to the heels; and therapy had worked to improve the
resident’s ankle flexion so that the fit of the Thera-Boot was improved. Weekly wound
assessment notes for the period May 15 through July 3, 2007, show that the heel ulcers
ealed but that a new sore formed on the resident’s coccyx or buttocks. P. Ex. 1, at 245-
50, 526, 531-34.

Brian Phillips, Physical Therapist, testified that he was requested on about May 1, 2007
to assist with obtaining a better fit with the Thera-Boot and a program was initiated to
improve the range of motion in the resident’s ankles. Although the resident never
completely cooperated, the fit of the Thera-Boots was improved and the heel ulcers were
ealing. P. Ex. 38, at 3-4. Mr. Phillips also testified that in mid-June 2007, a nurse asked
im to check a small eschar on the plantar region of Resident 3’s right foot at the edge of
the boot. The nurse suggested that the sore was caused by rubbing of the skin against the
boot. Mr. Phillips testified that he checked the boot and determined that it still fit
properly but he added a piece of gauze between the boot and the eschar as added
protection. P. Ex. 38, at 5-7. Mr. Phillips Therapy Progress Notes dated June 14, 2007
show that the eschar on the plantar surface was discovered on June 11, 2007, that it
appeared to be from the edge of the foot plate on the boot, and that he placed extra
padding that he did not secure to the boot, but left loose. P. Ex. 1, at 524.

60

A pressure sore risk assessment, referred to as a “Braden Scale” was completed on April
15, 2007. The assessment scored the resident at mild risk for the development of new
sores, but the assessment form that Petitioner used with the Braden Scale shows that the
assessment did not consider the contributing diagnosis of Alzheimer’s dementia and her
history of having a pressure ulcer. The assessment also did not consider that the resident
was cognitively impaired, that she had contractures, that she required assistance with
ADLs, that she used psychotropic drugs, that she had repeatedly complained of lower
extremity pain when lying in bed (P. Ex. 1, at 256), or that she had edema in her feet and
ankles, a possible sign or symptom of venous insufficiency (P. Ex. 1, at 583). The
interventions listed on the assessment form included the following: to turn and reposition
the resident every two hours; to monitor laboratory findings and weight; to keep linen dry
and wrinkle free; to keep skin clean and dry; to do peri-care after each incontinent
episode; to apply barrier cream after each incontinent episode; to encourage mobility and
ambulation; to have a nurse conduct weekly skin assessments; to monitor for pain and to
administer pain medication as ordered. CMS Ex. 27, at 284-85. A care plan dated April
23, 2007 that listed the problem of potential skin breakdown, listed the following
interventions: (1) to assist the resident every two hours with repositioning, if needed
(which is significantly different than the intervention recommended by the assessment to
turn and reposition every two hours); (2) a weekly skin assessment; and (3) the
requirement to report any open areas to a nurse. CMS Ex. 27, at 159; P. Ex. 1, at 595.
An undated entry on the copy of the plan introduced as evidence by Petitioner indicates
that it was discontinued because it was carried over to a skin care plan. P. Ex. 1, at 595.
However, the care plan for alteration in skin integrity, a copy of which was introduced as
evidence by both parties, does not include an intervention to turn and reposition every
two hours or to assist the resident in doing so. The skin integrity care plan also does not
include several other interventions identified by the April 15, 2007 assessment, including
monitoring of laboratory findings and weight; keeping linen dry and wrinkle free;
encouraging mobility and ambulation; or to monitor for pain and to administer pain
medications as ordered. CMS Ex. 27, at 160; P. Ex. 1, at 258. There is also evidence that
before the survey concluded Petitioner added the interventions of an air mattress and
floating the heels. P. Ex. 1, at 259.

Resident 3’s MDS with an assessment reference date of January 29, 2007 indicated that
Resident 3 could walk with limited assistance and could reposition herself in bed with the
assistance of one person. P. Ex. 1, at 169-70. The April 15, 2007 MDS indicated that she
was no longer ambulatory and required extensive assistance to reposition herself in bed
and to transfer from a wheelchair or a bed. CMS Ex. 27, at 15; P. Ex. 1, at 162.

Surveyor Lubick testified that Resident 3 was admitted to Petitioner with a pressure ulcer
on her coccyx and she was assessed in January 2007 as at risk for pressure ulcers due to
her existing ulcer and her impaired bed mobility and incontinence. Tr. at 86; CMS Ex.
27, at 19. She testified that when the resident was next assessed in April 2007, she was
61

no longer ambulatory but she no longer had a pressure ulcer. She opined that the decline
in Resident 3’s ability to ambulate increased her risk for pressure sores. However, she
did not find evidence that Petitioner added interventions to address prevention of pressure
sores in light of the residents decline in ability to ambulate. Tr. at 87-88. She testified
that the initial care plan dated January 21, 2007 that addressed skin integrity was
inadequate, for while it provided for assessing and recording weekly, repositioning every
two hours, and treatment as ordered, the plan did not address nutritional needs, the
specific treatments to be provided for the existing ulcer, and it did not address therapy
needs to attempt to increase mobility. Tr. at 89-90; P. Ex. 1, at 593. I note that the
nutrition and hydration sections on the plan are not completed, however the mobility plan
indicates that the resident is to be evaluated for therapies and encouraged to participate. I
further note that the initial care plan included a plan to check the resident for
incontinence every two hours, to assess her perineal area, to apply protective cream, and
to toilet her every two hours. P. Ex. 1, at 593. Surveyor Lubick testified that Resident
3’s care plan dated April 23, 2007 also required that the resident be repositioned every
two hours but that she found no record that turning was actually done every two hours.
Tr. at 91-96; CMS Ex. 27, at 159. She testified that the interventions listed on the care
plan dated February 6, 2007 were insufficient as the plan did not list encouraging
mobility, pressure reduction for the bed, elevating heels, dietary interventions, monitoring
and medicating for pain, or a wound care consultant. Tr. at 97; CMS Ex. 27, at 150-51.
She opined that the discovery of such large spongy areas on the resident’s heels recorded
on April 28, 2007 (CMS Ex. 27, at 290) was inconsistent with daily skin checks having
been done. Tr. at 98. The care plan dated February 6, 2007, required daily skin
inspections. CMS Ex. 27, at 160. She also testified that there was no evidence that staff
was elevating the resident’s heels. Tr. at 99. I note that the intervention of elevating the
eels is not checked on the February 6, 2007 care plan. CMS Ex. 27, at 160. A Shower
Day Worksheet/BodyAudit shows no skin issues on April 14, 2007, but shows blisters or
sores on both heels and the coccyx on April 28, 2007. Tr. at 99-100; CMS Ex. 27, at 282.
She opined that the spongy heels would have developed due to the resident having her
eels on the bed and possibly due to friction from sliding the resident, and before
blistering the skin would have appeared to be red. Tr. at 103. On April 9, 2007, the
physician ordered that “skin barrier preps” be applied to both heels twice a day and for
Thera-Boots to be used for both legs. CMS Ex. 27, at 52. Surveyor Lubick testified that
Thera-Boots are a splinting device that keeps the heels elevated. Tr. at 103. A
Repositioning Assessment completed by a physical therapist on May 2, 2007 specified
that the Thera-Boots were to be on securely at all times and checked every two hours for
pressure. CMS Ex. 27, at 234; Tr. at 103-04. Surveyor Lubick testified that she was
concerned about a Nutritional Progress Notes entry dated April 28, 2007 that states that
the resident’s skin was intact when it is documented that the resident had spongy heels.
She also testified that she located no documents that indicated that the dietician was ever
notified that Resident 3 had heel ulcers. She opined that the dietician should have
reassessed the resident for nutritional needs. Tr. at 104-05; CMS Ex. 27, at 134. She
testified that on May 29, 2007, Resident 3 had bilateral heel eschar, which is necrotic

62

tissue. She testified that a wound covered with eschar is “unstageable.” Tr. at 106-07. A
Shower Day Worksheet/Body Audit dated June 11, 2007, did not indicate an area of
eschar on the plantar surface of the right foot, only the sores on both heels. P. Ex. 1, at
404. Surveyor Lubick testified that on June 12, 2007 she observed an area of eschar on
the plantar surface of the resident’s right foot, on the ball or pad of the foot where the
hard plastic edge of the Thera-Boot met the foot. She testified that Resident 3 had a
downward flexion on her right foot which increased the probability of a pressure sore
where the Thera-Boot met the foot. Surveyor Lubick testified that on June 13, 2007, she
observed the eschar on Resident 3’s heels. She testified that on June 13, 2007 the wound
treatment nurse told her that the physician had not yet been notified of the new area of
eschar on the plantar aspect of the right foot. A Nurse’s Notes entry shows that the
physician was notified at 1:20 p.m. on June 13, 2007. She opined that it was an error for
staff not to have notified the physician on June 12 when the eschar was discovered. She
also noted that staff had failed to document in the Nurse’s Notes the discovery of the new
eschar on June 12, 2007 (CMS Ex. 27, at 291). She opined that if staff had been
checking the Thera-Boots every two hours as ordered and planned, they would have
noticed that there was redness, irritation or other change before the new area of eschar
developed. She opined that the new eschar could have been avoided had staff done the
planned examinations and monitored the foot, particularly because Petitioner’s records
show that in May 2007, Resident 3 was assessed as having plantar flexion contractures of
the right foot and had received physical therapy to address that problem. Tr. at 108-16.
She opined that Petitioner violated 42 C.F.R. § 483.25(c) in the case of Resident 3 and
that the violation was likely to cause serious injury, harm, impairment, or death because
Resident 3 was at high risk for ulcer development. Tr. at 121-22.

CMS called Daniel Berlowitz, MD who opined that the pressure sores that developed on
Resident 3’s heels were avoidable. Tr. at 333. He testified that the pressure sore on the
resident’s buttock at admission indicated that she was at risk for the development of
pressure ulcers regardless of the score determined using an assessment instrument. He
opined that given her limited mobility he assessed Resident 3 at moderate risk for
developing other pressure ulcers. He opined that the pressure sore was avoidable as there
were interventions available that were not used by Petitioner, including elevating the
resident’s heels or using a boot to keep the heels off the mattress. He noted that the issue
of pressure on the heels was not addressed by the care plan in effect prior to development
of the mushy heels. Tr. at 334-35. He opined that the ulcer that was discovered on the
plantar surface of Resident 3’s foot on June 12, 2007 was also avoidable because there
was some success at resolving the plantar flexion through physical therapy but the
restorative program was not continued and the evidence does not show that the resident’s
skin was being monitored every two hours as directed. He testified that some evidence
of skin damage would have been evident before eschar developed. Tr. at 338-40. He
testified that the presence of eschar indicates that there is a stage three or four ulcer which
is a deep tissue injury but they are generally treated as being unstageable. Tr. at 341. He
opined that the deep tissue injury had the potential to cause serious harm, including

63

serious infection. Tr. at 342. He opined that Petitioner did not do what was necessary to
avoid pressure sores as the evidence does not show that turning and repositioning were
accomplished, that heels were elevated or otherwise kept off the mattress, and the care
plan was not changed to reflect the resident’s loss of mobility. Regarding the eschar on
the plantar surface of the right foot, he opined that Petitioner did not do what was
necessary to address the contracture of the foot and to ensure monitoring. Tr. at 343-44.
He testified that he saw no evidence of peripheral vascular disease that might have caused
the heel ulcers. He opined that the plantar ulcer was more likely caused by rubbing on
the boot than vascular disease. He opined that the ulcers on the feet were not Kennedy
Terminal Ulcers and they were not part of the normal progression of Alzheimer’s disease.
Tr. at 348-50. He testified on cross-examination that, while a low-pressure mattress is an
accepted intervention, the mattress alone is often not enough. Tr. at 379. He testified
that Resident 3 entered the facility with a pressure ulcer in January 2007 and that
Petitioner had done a good job healing that ulcer. He testified that after the pressure ulcer
ealed in March 2007, Resident 3 became progressively less mobile. Tr. at 387-88. He
testified on cross-examination that pressure ulcers do commonly occur in people with
advanced Alzheimer’s disease. However, the fact that a person with advanced
Alzheimer’s developed pressure ulcers does not mean the ulcers are attributable to the
disease rather than a failure to reposition, to relieve pressure, or to address incontinence
problems. Tr. at 401-02. He opined that if skin assessments were being done as planned
and the Thera-Boot was being removed every few hours as planned, skin changes would
ave been noted before the eschar formed on the plantar surface of the foot. Tr. at 422-
23. I find that Dr. Berlowitz’s testimony is fully credible and persuasive.

Resident 3’s physician, Dr. Krause, could not recall whether Resident 3 had a pressure
ulcer on her coccyx or buttock when she entered the facility in January 2007 or whether
she had a history of a healed ulcer. He testified that he had not had time to review the
details of the resident’s clinical record prior to being called to testify, which causes me to
find his testimony less weighty than the testimony of Dr. Berlowitz who did review the
clinical record. Dr. Krause acknowledged that at some time the resident developed
mushy heels. He testified that he believed that interventions were in place to prevent
pressure sores. He opined that despite the interventions the pressure sores on Resident
3’s heels occurred anyway. He opined that Resident 3’s care plan was adequate and
appropriate. Tr. at 442-45. He testified that he believed the interventions he ordered
were being followed, although he did not state how he knew and he was not always
present at the facility. Tr. at 447. He testified that he believed that the treatment for
Resident 3’s heel pressure sores was “adequate, appropriate, and consistent with good
standards of care.” Tr. at 448. He opined that Resident 3’s Alzheimer’s played a
significant role in the development of the pressure ulcers due to her increased confusion,
decreased ability to ambulate, and increasing difficulty eating, maintaining good
nutrition, and her weight loss. He testified that it is a known risk that conditions such as
those experienced by Resident 3, place a person at significant risk for skin problems
including ulcerations. Tr. at 448-49. He testified that Resident 3 developed a pressure

64

sore from her Thera-Boot and he opined that it was unavoidable because the boot was
necessary to prevent further damage to the heels. Tr. at 468. He testified that the care the
resident received was consistent with the standards of care and did not put the resident at
risk for serious harm or death. Tr. at 469. He testified that there was no potential for
more than minimal harm. Tr. at 472. He agreed on cross-examination that skin would
appear red before eschar formed. Tr. at 497. I do not find persuasive Dr. Krause’s
opinion that Resident 3’s pressure sores were unavoidable. He readily admitted that he
had not reviewed the resident’s records prior to the hearing, thus his recollection of the
various interventions recorded in multiple documents in the clinical records is suspect if
not incredible. Further, Dr. Krause’s awareness of whether interventions were being
performed by staff as ordered is also suspect given the facts that he was not always at the
facility and he had not reviewed the record prior to the hearing. He recognized that the
resident’s decreased ability to ambulate may have contributed to her heel ulcers, but he
did not explain why there were no new interventions added to the care plan to address the
decreased ambulation after the April MDS was done. His testimony that the ulcer caused
by the Thera-Boot was unavoidable is also not persuasive given the testimony of Mr.
Phillips that he remedied the problem by adding a loose piece of gauze and the notation
in the clinical record that a piece of lamb’s wool was added to relieve the pressure and
shearing or friction. His opinion that there was no risk for serious harm or death or even
minimal harm is not credible. Dr. Berlowitz’s testimony that deep tissue injuries pose the
risk for serious infections that can cause death or serious harm is more persuasive.

Dr. Hansen testified that the eschar on the plantar area of Resident 3’s right foot might
not have been caused by unrelieved pressure. He testified that he was no expert in the
type of boot used but he opined that the eschar may have been caused by rubbing or
scraping. He stated he did not consider the eschar significant as the resident had larger
pressure sores on her heels. He testified that it would not be a standard of care to elevate
the heels of a resident assessed as at low risk for pressure sores, otherwise virtually all
nursing home residents would have their heels elevated. He testified that a weekly skin
assessment would be the standard of care for a resident at low risk for pressure sores. He
opined that the eschar on the plantar surface of Resident 3’s foot likely developed as a
blister from friction that then broke and became eschar. He opined that when the eschar
was found, it was properly treated, that it was not likely to cause serious injury, harm, or
death, or that it would have posed more than minimal harm. He opined that the heel
ulcers were properly treated with the Thera-Boot, physical therapy, and weekly skin
assessments, and the heel ulcers were healing and improving. Tr. at 662-70. He opined
that the heel sores were unavoidable because staff was doing screening and they
developed anyway. He opined that the heels were appropriately treated and were not
more likely than not to cause serious harm, injury, or death, but they were likely to cause
more than minimal harm. Tr. at 673. He testified in response to my questions that there
is no doubt that the resident’s mushy heels were caused by pressure on her heels. He
agreed that it was foreseeable that a resident who was often in bed would develop
pressure sores on her heels. Tr. at 700-01. He also admitted in response to my question
65

that the contracture of the resident’s foot and contact with the edge of the Thera-Boot
may have been enough pressure to cause the eschar on the plantar surface of the
resident’s foot within a few days. Tr. at 709-11. Dr. Hansen testified on cross-
examination that he opined that Resident 3 was at low risk for pressure sores based upon
an assessment done by Petitioner. However, he admitted that because the resident had a
pressure sore before, she was at risk to develop another pressure sore. He testified
however that the fact the resident had a prior pressure sore on her coccyx would not cause
him to order elevation of her heels. Tr. at 714-17. He testified that rotating the resident
in the bed to protect her coccyx and weekly skin assessments would be appropriate
interventions. Tr. at 719. Regarding the eschar on the plantar surface, he explained that a
pressure sore is caused by squeezing the blood out of the tissue until the tissue dies which
is different from rubbing the skin and causing trauma, though both will have a similar
appearance and in either case the injury was caused by the Thera-Boot. He agreed that if
staff had been checking the skin under the boot, they would have noticed some type of
mark before the eschar formed. Tr. at 721-22. He agreed that padding the Thera-Boot
would have avoided the problem. Tr. at 726. Dr. Hansen’s testimony was credible and
persuasive and it supports my findings and conclusions set forth hereafter.

Janet Lutze, RN, a wound care specialist, testified that it would be unusual for the Thera-
Boot to cause a pressure ulcer on the plantar surface of the resident’s foot. She opined
that the development of the eschar was not foreseeable. She opined that the eschar on the
plantar surface could have developed quickly with little prior indication. Tr. at 748-50.
She opined that the heel ulcers likely would have led to serious injury, harm, or death but
they were treated with the Thera-Boots. She opined that the eschar on the plantar surface
did not have the potential for even minimal harm. She opined that inadequate nutrition
leads to skin breakdown. Tr. at 757-59. She testified on cross-examination that she saw
the eschar on the plantar surface of Resident 3’s foot on June 26, 2007, and she opined
that it was healing. She admitted that she was not aware that physical therapy had
difficulty fitting the Thera-Boot and agreed that pressure on the foot caused by the
resident’s flexion of the foot could cause a pressure sore. Tr. at 760-61. She testified that
the Thera-Boot should have come off so the skin could be checked every two hours if
ordered and at least every four hours if not ordered for more frequent checks. She agreed
that it would be surprising, if the Thera-Boot was being removed and the skin was
checked every two hours, that the first sign of injury to the plantar surface was the eschar.
Tr. at 765. Nurse Lutze agreed with me that development of a pressure sore is a
significant change that requires that the care planning team get together to reassess the
care plan. But she testified that a spongy heel is not necessarily a pressure ulcer, rather it
is an indication that something may develop. Tr. at 770-72. She testified that when she
saw the resident’s heels in June 2007, the sores were static. Tr. at 772.

Mary Widner opined that Resident 3’s care plan for pressure ulcers was adequate, that
staff followed the plan and that the resident’s mushy heels and the eschar on the plantar
aspect of the right foot were due to her medical condition and unavoidable. She testified

66

that the pressure sores were not likely to lead to serious injury, harm, or death as they
were treated. She agreed that the ulcers were actual harm. Tr. at 976-82. She agreed on
my examination that Thera-Boots are not intended to cause eschar so the Thera-Boot
used for Resident 3 was either used incorrectly or it was not an appropriate intervention.
Tr. at 990-91. On cross-examination she agreed that the deficiency cited under Tag F314
had the potential for more than minimal harm but she felt staff did all they could. Tr. at
997-98.

I conclude that Petitioner violated 42 C.F.R. § 483.25(c) (Tag F314) because it failed to
leliver necessary care and services to Resident 3 to prevent the development of new
pressure ulcers. I further conclude that the determination that the deficiency posed
immediate jeopardy is not clearly erroneous.

The gist of the deficiency citation in the SOD is that Petitioner failed to deliver necessary
care and services to ensure that Resident 3 did not develop new pressure sores, after the
pressure sore she had on admission was healed. CMS Ex. 13, at 73-74. There is no
ispute that when Resident 3 was admitted to the facility on January 20, 2007, she had at
least one Stage II pressure sore on her buttocks.*° There is no dispute that the pressure
sores on Resident 3’s buttocks healed by February 28, 2007. There is no dispute that
Resident 3 remained a resident in the facility. There is no dispute that on April 28, 2007,
staff discovered that Resident 3 had developed spongy or mushy spots on her heels and
that such spots are considered to be pressure ulcers. Thus, CMS has satisfied the burden
of coming forward with sufficient evidence to make a prima facie showing of a violation
of 42 C.F.R. § 483.25(c)(2).

°° Petitioner’s clinical records are not clear regarding whether the resident had one or
two pressure ulcers when she was admitted. The MDS with an assessment reference date
of January 29, 2007, appears to indicate two ulcers, one a Stage I and one a Stage II. P.
Ex. 1, 171. However, a Weekly Pressure Ulcer Progress Report dated February 6, 2007
only describes one Stage II ulcer. But, an entry on the same form dated February 13,
2007 indicates there were two Stage II ulcers. A diagram on the form also shows two
ulcers, one on each buttock. CMS Ex. 27, at 278; P. Ex. 1, at 243. Nurse’s Notes that
record the weekly wound assessment are similarly confusing. P. Ex. 1, at 245. An
undated assessment indicates a Stage II ulcer on the right gluteal cheek. P. Ex. 1, at 222.
The Skin Integrity care plan indicates an ulcer on the right gluteal area on February 6,
2007, and an ulcer on the left gluteal area on February 13, 2007. P. Ex. 1, at 258.
Whether or not the resident had one or two ulcers when she was admitted does not affect
this decision as it is clear that she had a least one on admission.
67

Petitioner argues that there is no violation of 42 C.F.R. § 483.25(c)(1) in this case
because the resident was admitted to Petitioner with a pressure sore. Petitioner also
argues that there can be no violation of 42 C.F.R. § 483.25(c)(2) because the resident did
not have a preexisting pressure sore when the mushy heels developed and, according to
Petitioner, a resident must have another sore already present for 42 C.F.R. § 483.25(c)(2)
to be triggered by the development of a new pressure ulcer. P. Reply at 5-6. Petitioner’s
interpretation of the regulation and the Board’s prior decisions addressing the regulations
is in error. A facility will generally not be found in violation of 42 C.F.R. § 483.25(c)(1)
for the development of a pressure sore prior to admission of a resident to a facility.
However, as the Board has addressed repeatedly, 42 C.F.R. § 483.25(c)(2) clearly
obligates a facility to deliver necessary treatment and services to promote healing and to
prevent infection of an existing pressure ulcer, and to prevent the development of new
sores. Petitioner cites no authority in support of its interpretation of 42 C.F.R. §
483.25(c)(2) that when a facility resolves a preexisting sore, the facility may not be found
in violation of the regulation based on the development of a new pressure ulcer. The only
sensible reading of the regulation and the clear intent of the regulation is that a facility
must provide treatment and services necessary to heal a pressure ulcer that existed when a
resident is admitted and to prevent the development of any new sore while the resident is
under the facility’s care. The regulation establishes one defense for a facility and that is
that the development of new sores was unavoidable. Clermont Nursing and
Convalescent Ctr., DAB No. 1923, at 10.

Petitioner argues that the “appearance of a pressure sore after admission is a deficiency
only if it is not demonstrated to be unavoidable.” P. Br. at 6. Petitioner’s statement
reflects understanding that when CMS has made a prima facie showing of a violation, the
burden to show unavoidability is upon Petitioner. Petitioner argues that the development
of the heel ulcers and the plantar ulcer was unavoidable. Petitioner argues that after the
buttocks sores healed staff continued to assess the resident; that the April 15 assessment
showed the resident at low risk for new sores; that the resident’s care plan continued to
provide for a turning schedule and weekly skin assessments; that the standard of care did
not require floating the resident’s heels; that the plantar eschar was not a pressure sore
because it was probably caused by friction; and that the plantar eschar was caused by the
Thera-Boots which were prescribed as an intervention of the heel ulcers and should thus
be considered unavoidable. P. Br. at 6-10. Based on my review of the clinical records
and Petitioner’s arguments, I conclude that Petitioner has failed to show that the
resident’s heel and plantar sores were unavoidable.

Petitioner cannot show that the heel ulcers were unavoidable in this case because
Petitioner’s evidence does not show that the care planned interventions were
implemented. Petitioner’s care plan for Resident 3 related to skin integrity and the
avoidance of pressure sores is not found in one consolidated care plan. Rather,
interventions are found in various documents executed during the approximate five
month period from the resident’s admission to the survey. Resident 3’s initial care plan

68

dated January 21, 2007, required that she be repositioned every two hours. Her care plan
dated February 6, 2007, required daily skin inspections and to position her body with
pillows/support devices and to protect bony prominences. The pressure sore assessment
on April 15, 2007, specified that the resident should be turned and repositioned every two
hours. The April 23, 2007 care plan required that the resident be assisted with
repositioning every two hours if needed. But it is not clear whether the as needed
language of the April 23 plan referred to a need for assistance with repositioning or the
need to reposition. The April 23 care plan is nonsensical given that the April 15, 2007
MDS reflected a significant decrease in mobility, including bed mobility with extensive
assistance needed for repositioning in bed (CMS Ex. 27, at 15; P. Ex. 1, at 162), and that
the April 15 pressure sore assessment identified the need to turn and reposition the
resident every two hours (CMS Ex. 27, at 284). In fact, the copy of the April 23, 2007
care plan introduced by Petitioner shows on its face that it was discontinued and that the
skin care plan controlled.

Petitioner has failed to show in this case that the resident was turned and repositioned
every two hours as required by her care plan. Petitioner has failed to show that daily skin
inspections were done. Petitioner has failed to show that staff protected bony
prominences, such as the resident’s heels, by elevating her heels or otherwise. Petitioner
argues regarding turning that the April 23 care plan eliminated the need to turn and
reposition the resident every two hours (P. Reply at 8), but I find that argument neither
meritorious nor credible for the reasons already noted. Petitioner points to no evidence
that staff took any action to protect Resident 3’s bony prominences. Petitioner’s
argument that elevating the heels in a case like that of Resident 3 is not standard of care is
belied by the fact that Resident 3’s care planning team, including presumably Dr. Kraus,
adopted the intervention to protect bony prominences which includes the heels.

Petitioner also fails to identify evidence that shows that daily skin inspections were
actually completed for the Resident.

Regarding the development of the plantar eschar, Petitioner suggests first that it was not a
pressure sore at all. P. Brief at 8-9. However, that theory is inconsistent with the
testimony of Petitioner’s witness Dr. Hansen who agreed that contracture of the
resident’s foot and contact with the edge of the Thera-Boot may have been enough
pressure to cause the eschar after a few days. Dr. Hansen also agreed that if staff had
been checking the skin under the boot they should have seen some evidence prior to
formation of the eschar. Finally, he agreed that simply padding the boot would have
avoided the problem. Nurse Lutze, another of Petitioner’s experts, agreed that pressure
caused by the flexion of the resident’s foot causing contact with the boot could result in
pressure that would cause an ulcer and that the Thera-Boot should have been removed
every two to four hours so that the skin could be inspected. Nurse Lutze was also
skeptical that skin inspections were being done every two hours as ordered given that the
first sign discovered by staff was the eschar. Petitioner’s argument that initials entered
on a form each shift support an inference that the skin under the Thera-Boot was checked

69

every two hours as ordered (P. Reply at 8-9) fails due to the testimony of its own experts
that if checks were done as ordered, staff would have seen some sign of skin trauma prior
to the discovery of the eschar. Furthermore, the testimony of the physical therapist and
the documents show that the pressure caused by the contact between the plantar surface
and the boot was easily addressed after the eschar was discovered by simply adding
gauze or lambs wool as additional padding.

Accordingly, I conclude that CMS made a prima facie showing of a violation of 42
C.F.R. § 483.25(c)(2) and that Petitioner has failed to show that the development of
pressure ulcers was unavoidable.

I further conclude that the declaration of immediate jeopardy was not clearly erroneous.
Dr. Berlowitz opined that the heel ulcers posed the risk for serious harm, including the
risk for serious infection. Nurse Lutze opined that the heel ulcers would likely lead to
serious injury, harm, or death if not treated. Mary Widner agreed that all ulcers are at
least actual harm. The evidence supports the conclusion that Petitioner’s violation of 42
C.F.R. § 483.25(c) posed immediate jeopardy and Petitioner has failed to meet the burden
of showing that the determination of immediate jeopardy was clearing erroneous.

7. Petitioner violated 42 C.F.R. § 483.25(i)(I), Tag F325, as alleged by
the survey completed on June 27, 2007 (Affirmed).

8. The determination that Petitioner’s violation of 42 C.F.R. §
483.25(i)(1) posed immediate jeopardy was not clearly erroneous
(Affirmed).

This regulation requires that, based on a resident’s comprehensive assessment, a facility
must ensure that a resident maintains acceptable parameters of nutritional status, such as
body weight and protein levels, unless the resident’s condition demonstrates that this is
not possible. 42 C.F.R. § 483.25(i)(1).

The SOM instructs surveyors that the intent of the regulation is that a resident maintain
acceptable nutrition, to the extent possible, and requires that the facility: provide
nutritional care and services consistent with the resident’s comprehensive assessment;
recognize, evaluate, and address residents’ needs for nutrition; and provide a therapeutic
diet considering the resident’s condition and preferences when there is an assessed need.
The SOM indicates that weight is a parameter of nutrition and that unplanned or
unintended weight loss may indicate a nutritional problem. The SOM cautions that ideal
body weight charts have not been validated for the institutionalized elderly and weight
loss is only a guide for determining nutritional status. The SOM provides some suggested
parameters for surveyors to consider when evaluating the significance of weight loss.
Significant loss is weight loss of five percent in one month, seven and one-half percent in
three months, or ten percent in six months. Severe weight loss is loss greater than five

70

percent in one month, seven and one-half percent in three months, or ten percent in six
months. SOM, App. PP, Tag F325.

The Board has stated that weight loss alone does not support a deficiency but weight loss
does trigger an inference of inadequate nutrition. Carehouse Convalescent Hosp., DAB
No. 1799, at 21-22 (2001). Ifa facility shows by a preponderance of the evidence that it
“provided the resident with adequate nutrition” or that the weight loss was due to non-
nutritive factors, it can rebut a prima facie case based on such an inference. Carehouse,
DAB No. 1799, at 22. The Board’s interpretation of the regulation is that a facility is not
strictly liable for a resident’s weight loss (Carehouse, DAB No. 1799, at 21) but a
“facility is responsible for taking all reasonable steps to ensure that the resident receives
nutrition adequate to his or her needs.” Windsor House, DAB No. 1942, at 18 (2004).
The “clinical condition exception” is narrow and applies only when a facility
demonstrates that it cannot provide nutrition adequate for the resident’s overall needs so
that weight loss is unavoidable. Carrington Place of Muscatine, DAB No. 2321, at 5
(2010); Carehouse, DAB No. 1799; Windsor House, DAB No. 1942. The Board has
indicated that the presence of a significant clinical condition alone does not prove that
maintaining acceptable nutrition is unavoidable. Windsor House, DAB No. 1942, at 18.
In Windsor House, the Board found that surveyor observations that a resident was not
properly assisted with eating or that the facility was slow to react to a resident’s weight
loss was sufficient evidence that the facility failed to provide the resident with adequate
nutrition. Jd.

The surveyors allege that Petitioner violated 42 C.F.R. § 483.25(i)(1) in the case of
Resident 3 and that the violation posed immediate jeopardy to the resident. CMS Ex. 13,
at 99-113. The surveyors allege that Resident 3 experienced a severe weight loss of 17 to
23 percent from January 2007 through June 14, 2007, with the note that the survey team
was unable to make an accurate determination of weight loss due to discrepancies in the
facility records regarding the resident’s weight. The surveyors allege that Petitioner
failed to notify the registered dietician and physician of the weight loss; failed to assess
the cause of the weight loss; and failed to update the care plan with interventions to
prevent weight loss. The surveyors allege that immediate jeopardy began on June 4,
2007 and continued until immediate jeopardy was removed on June 14, 2007, but that the
deficiency remained and continued to pose a risk for more than minimal harm without
actual harm or immediate jeopardy. CMS Ex. 13, at 100.

The evidence shows that Resident 3 was admitted to the facility on January 20, 2007.
Her MDS with an assessment reference date of January 29, 2007, shows that she was 66
inches tall and weighed 194 pounds. CMS Ex. 27, at 5-6. Surveyor Lubick testified that
Resident 3 had a 10.6 pound weight loss at the beginning of April 2007 based upon
Petitioner’s weight records. She testified that Resident 3 had lost 23 pounds as of June 4,
2007. CMS Ex. 27, at 141-43; Tr. at 125. Petitioner’s records reflect the following
71

weights for Resident 3 with the gains or losses I have calculated from one weighing to the
next:

Date Weight Gain (+)/Loss (-) % Change
1/21/2007 193.6 Admission
2/6/2007 194.0 +0.4
2/9/2007 199.3 +53
3/4/2007 200.6 +13
4/1/2007 190.5 -10.1 5.03%
4/1/2007 192.1 -8.5 4.24% Reweigh —
Compared to
200.6#
5/1/2007 193.6 +1.5
6/4/2007 170.6 -23.0 11.88%
6/13/2007 148.7 -21.9 12.84%
6/14/2007 168.4 -2.2 1.29% Reweigh —
Compared to
170.6#
Overall 1/21/2007 to -25.2 13.02%
Change 6/14/2007
CMS Ex. 27, at 134-44. Thus, depending upon which weight is used for the calculation,
Resident 3 lost either 10.1 pounds or 8.5 pounds between the March 4 and April 1
weighings. Petitioner’s records show that Resident 3 lost more than twenty pounds
between May 1, 2007 and June 13 or 14, 2007, a loss of more than eleven percent. The

evidence also shows that Resident 3 had lost more than thirteen percent of her body
weight in the five month period, January to mid-June 2007. Petitioner concedes that
Resident 3 experienced a 11.9 percent to a 13 percent weight loss between January and
June 2007. P. Br. at 3. Petitioner also concedes a twenty pound weight loss between the
May weighing and the June weights. P. Br. at 4. Although the evidence shows that
Resident 3 was overweight when admitted, the evidence does not show that the weight
loss between January and June 2007 was planned weight loss. Accordingly, the weight
loss of more than five percent between May and June 2007, or the ten percent weight loss
between January and June 2007 raises an inference and amounts to a prima facie showing
of a lack of adequate nutrition. Thus, Petitioner has the burden of showing that the
weight loss was not due to a failure to provide adequate nutrition or that the failure to
maintain adequate nutrition was unavoidable.

Petitioner argues that the April reweigh showed only a 4.2 percent weight loss, which is
not considered significant under the SOM. Petitioner argues that it nevertheless
intervened by ordering a swallow study, ordering an occupational therapy assessment,
adjusting the resident’s psychotropic medications to reduce her lethargy, changing her to
72

a mechanical soft diet, and moving her to a second feeding. P. Br. at 4; P. Ex. 1, at 96,
98, 444, 446-47, 449, 454-56. An Interdisciplinary Resident Screen form dated April 16,
2007, that reflects the results of the occupational therapy and speech-language therapy
screens, shows that Resident 3 had experienced the following changes in condition: she
formerly required supervision for eating but was assessed as requiring assistance with
eating; and she had been pocketing food. P. Ex. 1, at 440. Petitioner argues that the
resident had a small increase in weight between the April and May 2007 weighings and
that the significant loss occurred in May and June 2007. After the weight in June
confirmed a significant weight loss, Petitioner’s power of attorney declined to approve
tube feeding of the resident on two occasions. Petitioner argues that a supplement was
ordered but that the resident would have lost weight without tube feeding no matter what
other interventions were attempted due to her advanced Alzheimer’s disease. Petitioner
argues that it took all reasonable measures but that the resident’s weight loss was
clinically unavoidable. P. Br. at 4-5. Petitioner also argues that the change in Resident
3’s consumption was not sufficient to give staff notice of a nutrition problem for the
resident. Petitioner cites the testimony of its expert, Dr. Hansen, in support of its
position. Dr. Hansen testified that he had reviewed the resident’s intake records. He
testified that the records would not have alerted the staff that the resident was in the
process of losing twenty pounds because the oral intake was recorded and, while she was
not eating 100 percent of meals, she was recorded to eat fifty to seventy-five percent for
some meals. He opined that based on what the record showed she was eating, she should
have been experiencing a gradual weight loss of about ten pounds per month rather than a
twenty pound weight loss in one month. Tr. at 675-78. Dr. Hansen did not and could not
vouch for the accuracy of Petitioner’s intake records for the resident. The records show
that in March 2007, the resident consistently ate fifty to 100 percent of her meals with
only three or four instances when she ate twenty-five percent. P. Ex. 1, at 397; CMS Ex.
27, at 311. The record for April 2007 shows fewer instances of 100 percent meal
consumption and many more instances of only twenty-five percent consumption. P. Ex.
1, at 398; CMS Ex. 27, at 313. The record for May 2007 shows few instances of 100
percent consumption; many instances of twenty-five percent consumption, and many
instances of no consumption. P. Ex. 1, at 400; CMS Ex. 27, at 315. I do not require an
expert to determine that the intake records for March, April, and May 2007 show that
Resident 3 was experiencing a significant decline in her intake of nutrition at meals.
Furthermore, Dr. Hansen’s testimony supports an inference that Petitioner’s recording of
meal consumption, particularly in late April and May, was probably overstated since even
the reweigh on June 13, 2007 shows a weight loss of more than twenty pounds, which is
twice the loss Dr. Hansen testified is supportable by the amount recorded as consumed by
the resident. I find no evidence, and Petitioner points to none, of any assessment of the
effectiveness of the interventions implemented in April. Petitioner cites no evidence of
any additional interventions, such as supplements, encouragement from staff, or weekly
weighings, implemented in late April and May despite the obvious reduction in the
resident’s consumption.

73

After reviewing all the evidence, I conclude that Petitioner failed to show that it provided
Resident 3 adequate nutrition to meet her needs beginning in April 2007 or that the
resident’s weight loss was unavoidable.

Surveyor Lubick testified that she was told by a member of the dietary department that
interventions for weight loss implemented in April included moving Resident 3 to an
assisted table and changing the resident’s diet. Tr. at 126. A Nutrition Progress Notes
entry dated April 17, 2007, shows that the dietician concluded that the resident had less
than or equal to a five percent weight change; that the resident’s intake was seventy-five
percent; that medications should be reviewed; and that the physician was to be notified of
the weight change. CMS Ex. 27, at 134. Nutrition Recommendations dated April 17,
2007, lists a weight loss of 10.6 pounds, which would have been a 5.28 percent weight
loss from the March 4 weight; notes that Resident 3 is sleeping through some meals;
recommends evaluation of the resident’s psychotropic medications; and recommends
notification of the physician. CMS Ex. 27, at 135-37. Physicians orders for April 18,
2007 are for speech therapy to evaluate the resident for oral dysphagia (CMS Ex. 27, at
50), and dose reductions in her Seroquel and Clonazepam with a psychiatric consultative
examination (CMS Ex. 27, at 51). On April 19, 2007 the physician ordered a diet change
to mechanical soft with ground meat due to pocketing of food and decreased chewing at
times; an occupational therapy evaluation of ability to self-feed and training in feeding
skills (CMS Ex. 27, at 51, 157). The eating care plan dated February 1, 2007 (CMS Ex.

27, at 152) was not updated to include t
occupational therapy interventions inclu
exercises were included on a separate th

e interventions from April 2007, except the
ding self-feeding training and upper extremity
erapy plan (CMS Ex. 27, at 157). Tr. at 139-40.

Surveyor Lubick testified that staff did not notify Resident 3’s physician of weight loss

revealed by the weighing done in early

une until she inquired during the survey. Tr. at

128-29; P. Ex. 1, at 78. The Nutrition At Risk Summary dated June 14, 2007, reflects
that Resident 3 suffered significant weight loss and pressure ulcers. The form also

reflects that it was faxed on June 14 an
receipt on June 16, 2007. P. Ex. 1, at 78
that ten days elapsed between the identi:
notify the physician on June 14, 2007. 1
interviewed the resident’s physician, he
identified in early June. Tr. at 131. She

again on June 15 and that the physician noted
. Surveyor Lubick testified that she concluded
fication of the weight loss and the attempt to

[r. at 129. She further testified that when she
stated that he was not aware of the weight loss
testified that she interviewed the dietician who

told her that she was unaware of Resident 3’s weight loss in May and June 2007. Tr. at

136. Surveyor Lubick opined that when
identified on June 4, 2007, there should
nutritional assessment, and the use of suy
found no evidence that Resident 3 had b
She opined that staff did not timely noti

the twenty-three pound weight loss was

ave been notification of the physician, a
pplements. Tr. at 134. She testified that she
een placed on a weight loss plan. Tr. at 137-38.
y the physician in April 2007, when Resident 3

experienced an 8.5 to 10.1 pound weight loss. Tr. at 139. She opined that the

interventions record in April 2007 were

inadequate because they did not include

supplements, address hydration, or require that staff encourage eating. Tr. at 140. She
74

opined that the nutrition assessment done at admission (CMS Ex. 27, at 133) was
insufficient as it did not address hydration needs. Tr. at 140-41. Surveyor Lubick
testified that Petitioner’s records for Resident 3 record declining consumption of food at
meals during the period March through June 13, 2007. Tr. at 142-45; CMS Ex. 27, at
311, 313, 315, 317. She testified that she found no evidence that Resident 3’s physician
was notified of the decreased food intake. She testified she found no evidence that the
dietician was advised of the decreased food intake or a dietary assessment related to the
decreased intake. Tr. at 145. She testified that Resident 3 made progress with
occupational therapy but she found no evidence that a restorative program was continued
after May 14, 2007, as recommended by the May 14, 2007 occupational therapy
discharge summary. Tr. at 147-49; CMS Ex. 27, at 377. She opined that Petitioner was
in violation of 42 C.F.R. § 483.25(i) in the case of Resident 3 and that violation was
likely to cause serious injury, harm impairment, or death. Tr. at 149-50.

Dr. Berlowitz testified that Resident 3’s approximate twenty pound weight loss between
May and June 2007 and her nutrition were not adequately addressed. Her documented
decrease in intake beginning late April and early May should have been addressed right
away. A diet change in April 2007 was followed by continued inadequate intake without
intervention by Petitioner. Given the resident’s documented inadequate intake and her
weight loss, he testified that he would be concerned about the adequacy of the resident’s
nutrition. He testified that he could not testify as to what interventions might have been
successful as interventions were not done. He opined that an assessment should have
been done to discover why Resident 3 was not eating; and then interventions should have
been attempted to improve her eating, including different food preparations and
supplements. He opined that inadequate nutrition could adversely affect pressure ulcers
and psychosocial well-being. Tr. at 361-66. On cross-examination Dr. Berlowitz opined
that Petitioner took appropriate first steps by having a speech therapist evaluate her
swallowing, changing her to a ground diet, and changing her eating schedule so that she
would have more assistance. But Petitioner did not follow-up and there was no
documentation of the effect of the changed interventions or that interventions were
changed when they did not work. He agreed that when a resident will no longer swallow
and the resident’s family will not authorize tube feeding that there is little a facility can
do, but a facility needs to assess and try alternative interventions such as more liquid
foods and supplements and do so in a systematic way. The facility needs to communicate
with the physician to determine what further evaluations may be required. Tr. at 394-98.
Dr. Berlowitz testimony is based upon the clinical record, it is credible, and I consider his
testimony weighty.

Dr. Kraus, Resident 3’s treating physician, testified that the resident was obese on
admission; that she was known to enjoy eating goodies and sweets; that it was not
unexpected that when her access to goodies and sweets was limited she would lose
weight; and that her weight loss was not medically inappropriate at the rate of about a
pound per week. He did not testify that he had approved or ordered a weight reduction

75

program for the resident, however. He recalled being notified by staff regarding the
resident’s weight loss in April 2007. He testified he issued orders to reverse or slow the
weight loss, including changing the time for her seating in the dining area, supplements
between and with meals, a speech therapy evaluation of swallowing, occupational
therapy evaluation, and a change in diet to modify food texture. Tr. at 450-55. He
testified that her anti-anxiety medication was adjusted due to concern that the resident
was being over-sedated to the extent that she was even falling asleep at meals. I note that
Dr. Kraus did not specify which interventions were ordered in April 2007 and which
were ordered in June 2007. For example there is no evidence that supplements were
ordered prior to June 2007. He testified that he believed his orders were followed,
though it is undisputed that he was not at the facility all the time and he did not review
the clinical record prior to the hearing. Tr. at 455-56. He opined that it is very common
in late-stage Alzheimer’s disease for people to lose their ability to receive adequate
nutrition related to impaired ability to swallow. Death ultimately results absent artificial
nutrition and Resident 3’s daughter had decided that tube feeding should not occur. Tr. at
456-59. He opined that the weight loss was unavoidable. Tr. at 459. He testified that he
was aware of the resident’s weight loss but attributed it to her advancing dementia. Tr. at
467. He opined that the care provided for weight loss and nutrition was consistent with
the standard of care, did not place the resident at risk for serious harm or death, and did
not pose a risk for minimal harm. Tr. at 468-72. The physician’s opinion that those
suffering late-stage Alzheimer’s disease often have difficulty with nutrition is not
disputed, but it is also not the issue. The issue is whether or not Resident 3 was receiving
adequate nutrition. Dr. Kraus’s opinions that Petitioner was doing all it could to ensure
that the resident was receiving adequate nutrition, particularly in April and May 2007, is
not weighty. Dr. Kraus did not review the clinical record prior to the hearing. His
testimony reveals that he was not aware of when he ordered particular interventions. He
was not in a position to assess whether or not his interventions were implemented as
ordered. He did not explain how the effectiveness of the April interventions was assessed
by the care planning team. He also did not address why other interventions —

e.g., supplements, encouragement, and weekly weighings — were not attempted in April
and May when the resident’s consumption was documented to continue to decline.

Doctor Hansen testified that it is common for an Alzheimer’s patient to stop eating and,
unless they are properly supplemented, they pass away. He explained that pocketing
food is common for an Alzheimer’s patient. He testified that poor nutrition is a risk
factor for the development of pressure sores. Tr. at 671-72. He opined that Resident 3’s
weight loss was unavoidable because Petitioner did intervene with a speech therapy
evaluation, occupational therapy, and changing her feeding so that she could have more
assistance. He opined that the weight-loss was unavoidable as the resident continued to
lose weight after interventions were changed following the survey. However, he did not
comment upon Petitioner’s failure to offer supplements in April and May 2007, despite
his testimony regarding the importance of supplements. Tr. at 674. He opined that
Resident 3 was not end-stage until after the survey. He testified that he would have
76

considered her terminal in April 2007, when she started losing weight. Tr. at 694-95. He
testified on cross-examination that he did not believe that the weight records for Resident
3 accurately reflected her weight. He agreed that a twenty pound weight loss in one
month would be significant and the physician should be informed. He testified that he
believed that Resident 3 did suffer a twenty pound weight loss between April and June
2007. He agreed that prior to the survey, the resident was not receiving nutritional
supplements except with her medications. Tr. at 727-32. Dr. Hansen’s testimony is
credible and it supports my conclusion that Petitioner should have attempted additional
interventions such as supplements in April and May 2007.

Mary Widner testified that the weight loss was unavoidable as there was an adequate plan
to address nutrition and staff was attempting to feed the resident, her diet was modified,
and staff was attempting to address the resident’s nutritional needs. She opined that the
alleged deficiency was not likely to cause serious injury, harm, or death. Tr. at 981-83.
Ms. Widner did not specify whether she thought that the interventions in April 2007 were
adequate or whether her opinion was based upon the interventions finally implemented in
June and July 2007. Thus, her opinion is not helpful. Her opinion that a failure to ensure
a resident’s nutritional needs are met, is not likely to cause serious injury, harm, or death,
is not credible. Obviously, as a qualified nurse with long experience in the field of long-
term care, Ms. Widner was aware that resident’s can suffer serious harm or death due to
malnutrition. To the extent that Ms. Widner was opining that Resident 3 received the
care and services necessary to avoid serious harm, injury, or death, I do not find that
opinion weighty as to the period April and May 2007 when the resident’s intake
continued to decline but the evidence does not show that new interventions such as
supplements, more frequent weighing, or encouragement to eat were implemented.

Accordingly, I conclude that Petitioner has not shown by a preponderance of the evidence
that it provided the resident with adequate nutrition or that the weight loss was due to
non-nutritive factors, or that it did all it could reasonably do to prevent weight loss, which
I conclude was indicative of inadequate nutrition in this case. I further conclude that
Petitioner has not addressed and has not met its burden to show that the determination of
immediate jeopardy was clearly erroneous in this case. Indeed, it is not disputed that
failure to receive adequate nutrition may cause serious harm, injury, or death.

9. Petitioner returned to substantial compliance effective August 3,
2007.7!

3! The Board specified that I was to address this Conclusion of Law only if my
Conclusion of Law 10 changed on remand. Columbus Nursing and Rehab. Ctr., DAB

(Continued next page.)
77

Petitioner alleged in its plan of correction for the survey that ended on June 27, 2007, that
all elements of the plan would be implemented not later than August 3, 2007. CMS Ex.
15. The plan of correction was accepted by CMS on August 2, 2007. CMS Ex. 15, at 1,
2. A revisit survey on August 14, 2007, resulted in findings that all the deficiencies from
the June 27, 2007 survey were corrected except for Tags F157 and F309, as of the date of
the revisit, August 14, 2007. CMS Ex. 62. The evidence does not show that the
surveyors considered any earlier date for correction, such as August 3, 2007, the date
Petitioner alleges it completed all corrective action for all deficiencies cited by the June
27, 2007 survey and returned to substantial compliance. CMS argues that Petitioner
continued not to be in substantial compliance based upon continuing deficiencies under
Tags F157 (42 C.F.R. § 483.10(b)(11)) and F309 (42 C.F.R. § 483.25) and, therefore
Petitioner did not return to substantial compliance on August 3, 2007. The deficiencies
under Tags F157 and F309 as found by the survey completed on August 14, 2007, are
discussed hereafter. CMS did not discuss in briefing and does not appear to dispute
Petitioner’s assertion that it corrected all other deficiencies by August 3, 2007.

Roberta Messer, a licensed RN and nursing home administrator, was called to testify by
Petitioner. Ms. Messer testified that she was Petitioner’s interim nursing home
administrator from May to August 2007, and that she was involved in developing and
implementing the plans of correction. Tr. at 801-03. She testified that she was the
overall coordinator for the plans of correction and that the plans were accepted by CMS
and the state agency. She testified that the plans of correction for the survey completed
on June 27, 2007, were fully implemented on August 3, 2007. Tr. at 803-04.

Janet Lutze, RN, testified that she was hired by Petitioner as a wound care consultant to
help develop and implement the plan of correction related to wound care and she
completed training staff in July 2007. Tr. at 746-47.

The testimony of Ms. Messer and Nurse Lutze is unrebutted. I conclude that Petitioner
completed correction of the deficiencies cited by the June 27 survey as listed on CMS Ex.
62, not later than August 3, 2007. As discussed hereafter, I also conclude that there was
no continuing violation under Tags F157 or F309. Accordingly, I conclude that
Petitioner returned to substantial compliance with program participation requirements
effective August 3, 2007.

(Continued from preceding page.)

No. 2398, at 9 n.8. My Conclusion of Law 10 is unchanged though I have added
discussion to address the issues raised by the Board.
78

10. Petitioner did not violate 42 C.F.R. § 483.10(b)(11), Tag F157,
contrary to the allegations of the August 14, 2007 revisit survey (On
Remand).

a. Text From Original Decision

During the revisit survey of August 14, 2007, Petitioner was found to be in violation of
42 C.F.R. § 483.10(b)(11) and the surveyors alleged the violation caused actual harm.
Section 483.10(b)(11)(i) of 42 C.F.R. entitled, “Resident rights,” requires:

(11) Notification of changes. (i) A facility must immediately
inform the resident; consult with the resident’s physician; and
if known, notify the resident’s legal respresentative (sic) or an
interested family member when there is --

(A) An accident involving the resident which results in injury
and has the potential for requiring physician intervention;

(B) A significant change in the resident’s physical, mental, or
psychosocial status (i.e., a deterioration in health, mental, or
psychosocial status in either life-threatening conditions or
clinical complications);

(C) A need to alter treatment significantly (i.e., a need to
discontinue an existing form of treatment due to adverse
consequences, or to commence a new form of treatment); or

(D) A decision to transfer or discharge the resident from the
facility as specified in Sec. 483.12(a).

The regulatory requirements are clearly stated. The regulation requires that a facility
“must immediately .. . consult with the resident’s physician . . . when there is a
significant change in the resident’s physical, mental, or psychosocial status” (meaning a
deterioration in the resident’s condition). 42 C.F.R. § 483.10(b)(11) (emphasis added).
The requirement is not discretionary and it requires more than merely informing or
notifying the physician, which is evident from the plain language of the regulation. The
drafters chose the language carefully. The regulation is specific that the facility is
required to immediately “inform the resident; consult the physician; and . . . notify the
legal representative or an interested family member.” Jd. (emphasis added). The
preamble to the final rule indicates the drafters’ specific intention that the facility should
“inform” the resident of the changes that have occurred but should “consult with the
physician about actions that are needed.” 56 Fed. Reg. 48,826, 48,833 (Sept. 26, 1991).
Thus, it is clear from the language of the regulation and its history that the requirement of
79

the regulation to consult means more than to simply notify. Consultation requires a
dialogue with and a responsive directive from the resident’s physician as to what actions
are needed; it is not enough to merely notify the physician of the resident’s change in
condition. Nor is it enough to leave just a message for the physician. Also, the facility
must provide the physician with all the information necessary to properly assess any
changes to the resident’s condition and to determine what course of action is necessary.

The regulation also requires consultation “immediately” upon discernment of a
significant change in condition of the resident. The use of the term “immediately” in the
regulatory requirement indicates that consultation is expected to be done as soon as the
change is detected, without any intervening interval of time. It does not mean that the
facility can wait hours or days before consulting with the physician. The preamble to the
final rule indicates that originally the proposed rule granted the facility up to 24 hours in
which to notify the resident’s physician and the legal representative or family. However,
after the receipt of comments that time is of the essence in such circumstances, the final
rule amended that provision to require that the physician and legal representative or
family be consulted/notified immediately. 56 Fed. Reg. 48,833. The point of using the
word “immediately” was the recognition that in such situations a delay could result in a
situation where a resident is beyond recovery or dies. Furthermore, when we balance the
relative inconvenience to a physician and the facility staff to consult about a resident’s
change in condition with the possibility for dire consequences to the resident if the
physician is not consulted, it seems that any inconvenience certainly is inconsequential
and outweighed by the potential for significant harm if the facility fails to consult the
physician. It is better to err on the side of consulting a physician regarding a change in a
resident’s condition rather than not or debating about whether the change is significant,
particularly since nursing home staff may not be qualified or competent to identify the
significance of signs and symptoms. This regulatory requirement is included in the
regulation entitled “Resident rights” and the requirements of this specific regulation
provide that every resident has the right to a dignified existence and access to and
communication with persons and services inside and outside the facility. Therefore, the
regulatory requirements make inconsequential any inconvenience under the regulation to
the resident’s physician or to the facility staff when compared to the protection and
facilitation of the rights of the resident. See 56 Fed. Reg. 48,834.

[he SOM instructs surveyors as to the CMS policy related to this deficiency, as follows:

For purposes of § 483.10(b)(11)(i)(B), life-threatening
conditions are such things as a heart attack or stroke. Clinical
complications are such things as development of a stage II
pressure sore, onset or recurrent periods of delirium, recurrent
urinary tract infection, or onset of depression. A need to alter
treatment “significantly” means a need to stop a form of
treatment because of adverse consequences (e.g., an adverse
80

drug reaction), or commence a new form of treatment to deal
with a problem (e.g., the use of any medical procedure, or
therapy that has not been used on that resident before).

SOM, app. PP, Tag F157.

The August 14, 2007 revisit survey alleges that Petitioner violated 42 C.F.R. §
483.10(b)(11) (Tag F157) and that the violation caused actual harm to Resident 2.
Resident 2 had a diagnosis of Muscular Sclerosis (MS); she suffered from severe
contractures; she had a history of urosepsis; and a history of septic shock. CMS Ex. 63,
at 3. On August 9, 2007 at 12:30 p.m., nursing staff documented that Resident 2 had a
two by one centimeter hard, rough mass protruding one centimeter from the vaginal
opening that was “grey in color, painful [with] slight touch” and a white discharge was
noted. Resident 2’s vital signs were not recorded in the Nurse’s Note recording the
examination. CMS Ex. 68, at 4; Tr. at 542. Thirty five minutes later, at 1:05 p.m., the
staff called Resident 2’s physician and left a message with the physician’s nurse
regarding this mass. CMS Ex. 68, at 4. There was no evidence that Resident 2’s
physician returned the call. Tr. at 543. A Nurse’s Notes entry at 9:30 p.m. on August 9,
2007 shows that Resident 2 refused her evening meal despite being offered different
choices at different times; that she was taking minimal water with meals with minimal
urinary output; but she had no complaint of pain or discomfort. CMS Ex. 68, at 4. On
August 10, 2007 at 9:45 a.m., Resident 2 had a temperature of 100 degrees and
complained that she did not feel well, but she denied pain or discomfort. CMS Ex. 68, at
5. The physician on call was contacted and updated on the mass in the resident’s vagina,
the fact that she had a temperature, and the fact that she had refused food and fluids. The
on-call physician ordered that Resident 2 be sent to the emergency room. CMS Ex. 68, at
5. Approximately 20 hours elapsed from the first call to Resident 2’s physician at 1:05
p.m. on August 9 and 9:45 a.m. on August 10 when the on-call physician was notified.
Nurse’s Notes reflect that it was not uncommon for the resident to refuse meals and fluids
except for taking a little water. CMS Ex. 68, at 1-4.

Resident 2 arrived at the hospital awake and alert, in moderate distress, and with a
temperature of 100.7 degrees Fahrenheit. A vaginal examination was deferred due to
excruciating discomfort from trying to position her for the examination and it was
determined to do the examination under sedation. Urinalysis revealed the resident was
suffering from a urinary tract infection. CMS Ex. 68, at 13. After Resident 2 was
sedated, a large foreign mass was extracted from her vagina that appeared to be stool.
The physician speculated that the mass of stool had either built-up in her vagina or
entered her vagina through a fistula, but he did not determine a cause. The physician
observed ulcerations in the vagina but found no fistula or perforation of the rectum into
the vagina. The physician ordered intravenous antibiotics due to a severe urinary tract
infection and to “avoid septic complications” due to the mass with a 24-hour hospital stay
followed by a course of antibiotics on return to the nursing facility. CMS Ex. 68, at 15.
81

On August 11, 2007, Resident 2 was discharged from the hospital and returned to the
facility. Tr. at 549.

CMS alleges that at 1:05 p.m. on August 9, 2007, Petitioner obtained knowledge of a
significant change of condition that required immediate consultation with the physician
but the consultation did not occur. CMS also argues that the condition required a
significant change in treatment as evidenced by the fact that the order was given for the
resident to go to the emergency room. CMS Br. at 21-22; Tr. at 542.

Surveyor Ann Angell testified that Resident 2 was dependent upon staff for all cares
except that she could use an adaptive cup and obtain her own water. She testified that the
resident had severe contractures of her arms and legs and her care plan required the use of
splints for both upper and lower extremities. Tr. at 522; CMS Ex. 34, at 5, 25. Surveyor
Angell testified that she participated in the survey of Petitioner’s facility that ended on
August 14, 2007 and she made the findings under Tag F157 related to Resident 2.
Surveyor Angell testified that she was concerned that when the mass was found, the
resident’s vital signs were not recorded. She was also concerned because the resident had
a history of septicemia and the discharge could have been a sign of infection. She opined
that Resident 2 required immediate medical attention. She testified that the clinical
record showed that the resident had vague complaints of nausea and not feeling well and
she did not eat at times. She testified that the evidence shows the physician was called
and staff left a message but the physician did not return the call. Surveyor Angell

testified that she was concerned that the record showed that the resident did not eat the
evening meal on August 9, drank little water, and had little urine output, but there was no
assessment of the mass, no indication that the physician was called again, and no report
that vital signs were assessed. She testified that the resident was listed on the facility 24-
hour report for August 9, with the indication that the physician had been updated. She
testified that the record shows that the physician on call was contacted and updated on
August 10 and he ordered that the resident be sent to the emergency room. Tr. at 541-45.
She testified that on August 9, the physician should have been called again after a
reasonable time of an hour, if there was no contact with the treating physician the on-call
physician or the medical director should have been contacted, and the resident’s vital
signs should have been monitored for possible indication of infection. She opined that
the circumstances reflected a significant change in condition that required consultation
with the physician, because the mass was not supposed to be there, it was painful to light
touch, the discharge indicated a possible infection, and the resident’s history of sepsis.

She opined that the resident had a significant change of condition within the meaning of
Petitioner’s policy at P. Ex. 11 and there was a need for a significant change in the
resident’s treatment. She opined that staff failed to follow facility policy regarding the
ange in condition. She opined that the resident suffered actual harm due to the pain she
experienced and the delayed treatment. Tr. at 546-60. However, she admitted in
response to my questioning that she did not know whether the pain was secondary to the
mass or due to her contractures and her examination. Tr. at 576. She admitted on cross-

fe)
82

examination that throughout the day on August 9, 2007, there is no evidence of the
resident complaining of pain and when the resident was examined the next morning and
she was found to have an elevated temperature the physician was called immediately. Tr.
at 584. She testified that the mass in the vagina caused ulcerations that might have been
lessened had the mass been removed more promptly. Tr. at 585, 593.

Roberta Messer, Petitioner’s Administrator during the surveys, testified that there was no
significant change in the resident’s condition that required consultation with the
physician. She opined that the resident’s problem with her contractures was chronic and
that the pain was due to her contractures not the mass that was discovered. She also
opined that the resident was not exposed to a risk for significant harm due to the delay in
sending her to the hospital because she was being monitored. She further attributed the
fact that resident had a fever to the fact that she had a urinary tract infection, which was
not uncommon for her due to her neurogenic bladder and catheter. Tr. at 844-47.

Mary Widner opined that staff timely consulted with the physician for Resident 2 by
consulting him in less than 24 hours. She opined that there was no acute change in
condition that required immediate consultation. She opined that there was no emergency
as the mass had obviously been present for some time and there was no change in the
resident’s condition. She opined that the delay in consulting with the physician did not
pose a risk for even minimal harm. Tr. at 985-87.

I am convinced based upon the policy guidance of the SOM that the facts do not amount
to a violation of the regulation because there was no significant change in the condition
of the resident or need to significantly alter care within the meaning of the regulations on
August 9, 2007. When on August 10, 2007, Resident 2 manifested signs and symptoms
consistent with a possible infection, staff immediately consulted with the on-call
physician who ordered that the resident be sent to the emergency room for treatment.
Accordingly, I conclude that Petitioner did not violate 42 C.F.R. § 483.10(b)(11) and the
alleged violation is no basis for the imposition of an enforcement remedy.

b. Additional Analysis On Remand

The Board expressed concern in the remand decision that I did not conduct a complete
analysis. To the contrary, my analysis was complete and correct, but like the anxious
math student at the end of a long examination, I simply failed to show all my work to
arrive at the correct answer.
83

There is no dispute that on August 9, 2007 at 12:30 p.m., nursing staff discovered and
documented that Resident 2 had a two by one centimeter™ hard, rough mass protruding
one centimeter from the vaginal opening that was “grey in color, painful [with] slight
touch” and a white discharge was noted. Resident 2’s vital signs were not recorded in the
Nurse’s Note recording the examination. CMS Ex. 68, at 4; Tr. at 542. Staff called the
resident’s physician about 1:05 p.m., but had to leave a message with the physician’s
nurse. CMS Ex. 68, at 4. There was no evidence that Resident 2’s physician returned the
call. Tr. at 543. A Nurse’s Notes entry at 9:30 p.m. on August 9, 2007 shows that
Resident 2 refused her evening meal despite being offered different choices at different
times; that she was taking minimal water with meals with minimal urinary output; but she
had no complaint of pain or discomfort. CMS Ex. 68, at 4.

The first step in the analysis under the regulation is to determine whether or not the
foregoing facts describe:

e An accident with injury that has a potential to require physician
intervention:

e A significant change in physical, mental, or psychosocial status;

e A situation that requires significant alteration of treatment; or

e A situation where a decision is made to transfer or discharge the resident.

If any one or more of the conditions was met on August 9, 2007, the facility’s duty to
consult with the resident’s physician under 42 C.F.R. § 483.10(b)(11)(i) was triggered.
The surveyors and CMS do not allege that the facts described show that an accident
occurred or that a decision was made to transfer or discharge the resident.

The surveyor, Ann Angell, alleged in the SOD that the duty to consult was triggered by a
“significant change of condition” that was observed at approximately 12:30 p.m. on
August 9, 2007. CMS Ex. 63, at 2, 7. Surveyor Angell opined that the mass was a
significant change because it is not normal for such a mass to be in that location, it was
painful to touch, there was drainage which she felt might indicate an infection, and the
resident was at risk for infection. Tr. at 546, 549. I do not find Surveyor Angell’s
opinion to be weighty as it is not based upon either the regulatory definition or the SOM
explanation of the regulatory standard discussed hereafter. Furthermore, Surveyor Angell
also opined that the physician should be consulted for any change in condition. Tr. at
552. However, she agreed that not every call to a physician is related to a significant
change. Tr. at 582-83. Surveyor Angell’s testimony indicates that she did not understand

* The diameter of a U.S. penny is approximately two centimeters.
84

the regulatory standard or the SOM guidance when citing the deficiency, which further
undermines the weight of her opinions and conclusions.

CMS argued to me that there was a significant change in condition as alleged by the
surveyor. CMS also argued the additional ground that there was a need for significant
alteration of treatment evidenced by the fact the resident was sent to the emergency room
on August 10, 2007. * CMS’s position is that the change in physical status and need to
significantly alter treatment occurred at approximately 12:30 p.m. on August 9, 2007.
CMS Brief at 21-22; CMS Reply at 25-27.** The CMS arguments are not persuasive.

33 The Board directed that I address whether or not CMS timely raised the issue of
whether there was need for a significant change in treatment. Columbus Nursing and
Rehab. Ctr, DAB No. 2398, at 15 n.9. The surveyor alleged only that the facility failed
to consult with the physician when there was a significant change in condition. CMS Ex.
63, at 2, 7. CMS did not raise the issue of whether there was a need for a significant
change in treatment in its prehearing brief dated May 9, 2008. CMS Prehearing Brief at
41-42. CMS did not raise the issue in its opening statement at trial. Tr. at 32-34. CMS
first advanced the additional grounds for a violation of 42 C.F.R. § 483.10(b)(11)(i) in
post-hearing briefing. Although I gave the parties the opportunity to address the Boards
Remand decision, they declined to do so and CMS has waived the opportunity to
comment upon the issue. CMS did not timely raise the issue of whether or not there was
a need for a significant change of treatment; the government failed to give Petitioner
timely and sufficient notice of the alternate theory for liability; and the CMS allegation
could be rejected for that reason. However, out of an abundance of caution I addressed
the merits of the argument for the Board.

* CMS also argues that Petitioner’s staff failed to record the resident’s vital signs on
August 9, 2007. There is no dispute that vital signs are not recorded. However, the
surveyors did not allege any deficiencies based on a failure to properly assess Resident 2
or deliver necessary care and services on August 9, 2007. CMS also argues that
Petitioner failed to follow its own policy. However, there is no regulatory requirement
that Petitioner issue or implement a policy related to the identification and reaction to
significant changes. To the extent that CMS cites the facility policy as evidence of a
standard of care, Petitioner was not cited for failure to deliver professional services or to
deliver necessary care and services. The charge by the surveyor only alleges a violation
of 42 C.F.R. § 483.10(b)(11). CMS Ex. 63, at 1. CMS has the very low burden of
proceeding by showing a prima facie case of the noncompliance as alleged in the SOD.
However, CMS is responsible to ensure that its proof actually relates to the cited

noncompliance. If CMS was not satisfied with the citation of noncompliance in the SOD,
(Continued next page.)
85

The regulation describes a significant change as “deterioration in health, mental, or
psychosocial status in either life-threatening conditions or clinical complications.” 42
C.F.R. § 483.10(b)(11)(B).*° The regulation describes a need to alter treatment
significantly as “a need to discontinue an existing form of treatment due to adverse
consequences, or to commence a new form of treatment.” 42 C.F.R. § 483.10(b)(11)(C).
The same definitions appear in the SOM, App. PP, Tag F157. CMS further elaborates in
the SOM that “life-threatening conditions are such things as a heart attack or stroke;” and
“{c]linical complications are such things as development of a stage II pressure sore, onset
or recurrent periods of delirium, recurrent urinary tract infection, or onset of depression.”
CMS explains in the SOM that the need to alter treatment “significantly” means a need to
stop a form of treatment because of adverse consequences such as an adverse drug
reaction, or commence a new form of treatment to deal with a problem, such as the use of
any medical procedure, or therapy that has not been used on that resident before.

The evidence shows that on August 9, 2007 at 12:30 p.m., staff observed a two by one by
one centimeter mass protruding from the resident’s vaginal opening; it was very painful
with slight touch; a yellow-white discharge was noted; and a foul odor was noted. CMS
Ex. 68, at 4; P. Ex. 2, at 89. The contemporaneous medical record is the most credible
description of the mass and the resident’s clinical presentation. Comparing the
description of the mass and the resident’s signs and symptoms with the definitions of the
regulation and the further policy guidance of CMS in the SOM, I conclude that the mass
was not of the same significance as a heart attack or stroke, the development of a stage II
pressure sore, the onset or recurrence of periods of delirium, recurrent urinary tract
infection, or the onset of depression. I also conclude that on August 9, 2007, the mass
did not require, on an emergency or immediate basis, a new form of treatment, medical
procedure, or therapy that had not been used before within the meaning of the regulation.
Resident 2 was already being treated for major depression. P. Ex. 2, at 73-74. Resident 2
had also had a prior urinary tract infection diagnosed on about June 29, 2007, which
cleared after a ten day course of antibiotic. P. Ex. 2, at 76, 79-81, 265.

(Continued from preceding page.)

CMS certainly had authority to reopen and revise its determination at any time prior to
the hearing and give Petitioner proper notice thereof.

* The drafters of the regulation used the abbreviation “i.e.” which indicates that the
quoted language, which appears in parentheses in the regulation, was intended to clarify
the meaning of the provisions rather than simply provide examples, which would have
been indicated by use of the abbreviation “e.g.”
86

On August 10, 2007, the resident was transported to the hospital where the mass could be
removed under anesthesia to minimize the resident’s pain associated with the
contractures that limited access to the area without pain. Even if one concluded that the
removal of the mass constituted a new medical procedure or that the initiation of
antibiotics was a new form of treatment, the evidence does not show that the resident was
at risk for more than minimal harm due to the 20-hour delay to remove the mass or begin
antibiotics. The evidence shows that on August 9, 2007, the resident reported no
complaints of pain or discomfort other than the pain related to the attempt to examine the
mass. CMS Ex. 68, at 4-5; P. Ex. 2, at 89-90. The evidence shows that the resident
refused her evening meal on August 9 and was taking very little fluid, but that was not a
new problem for the resident as she had been refusing meals and had decreased fluid
intake and output for some time and interventions had been implemented to address the
problems. P. Ex. 2, at 78, 87-89, 106. On August 5, 2007, the resident had complained
of nausea which she associated with the protein powder being added to her juice. P. Ex.
2, at 89.

I will not infer from the fact that staff called the physician on August 9, 2007, that staff
believed there was a significant change that required consultation with the physician.

The Nurse’s Notes entry at 1:05 p.m. on August 9, 2007, states that the physician was
updated by a message left with his nurse regarding the mass in the vaginal area. CMS
Ex. 68, at 4. The note does not indicate that staff expressed a need for an urgent response
from the physician or otherwise indicated that immediate medical attention was required,
which would have been indicated by a request for new treatment or order to send the
resident to the hospital. As Ms. Angell testified on cross-examination physicians are
often contacted by staff when there is no significant change. Tr. at 582-83.

I also will not infer from the fact that the on-call physician directed that the resident be
sent to the hospital on August 10, 2007, that there was a significant change or need to
significantly alter treatment on August 9, 2007. On August 10, 2007 at 9:45 a.m.,
Resident 2 had a temperature of 100 degrees and complained that she did not feel well,
though she denied pain or discomfort. CMS Ex. 68, at 5. The physician on call was
contacted and updated on the mass in the resident’s vagina, the fact that she had a
temperature, and the fact that she had refused food and fluids. The on-call physician
ordered that Resident 2 be sent to the emergency room. CMS Ex. 68, at 5. All the
reasons the on-call physician elected to have the resident sent to the emergency room on
August 10, 2007, are likely not reflected in the evidence. However, an inference can be
drawn that the on-call physician was not the resident’s treating physician and he had only
the information provided by the staff by telephone, including that the resident was not
feeling well; she had a vaginal density or foreign object; a temperature; and though not
recorded in the notes, he probably believed that she was old based on the fact she was
from the nursing home. The Nurse’s Note clearly states however that the resident was
being sent to the hospital for evaluation. CMS Ex. 68, at 5. The examination notes from
the hospital show that vaginal examination had to be deferred due to excruciating

87

discomfort trying to position the resident and that the examination would be done under
anesthetic or sedative. CMS Ex. 68, at 13-14. Subsequent to the administration of
anesthetic, the mass was simply removed by forceps. CMS Ex. 68, at 15. After the
procedure, the only ongoing treatment was antibiotics for a urinary tract infection. CMS
Ex. 68, at 12. The records related to the procedure to remove the mass and the follow-up
with antibiotics to treat a urinary tract infection, do not describe a life threatening
situation or clinical complications similar in magnitude to the illustrations of those
phrases used by CMS in the SOM. While the addition of an antibiotic to treat the urinary
tract infection is a change in treatment, it is not a significant change as the treatment of
nursing home residents with antibiotics is common and the evidence shows Resident 2
was treated with antibiotics for a urinary tract infection the month before. The fact that
the resident was sent to the hospital is also not persuasive evidence that the on-call doctor
thought the resident required emergency care or that the resident was experiencing a
significant change. Clearly the resident did not have a prior appointment to see the on-
call doctor in his office, if he had an office outside the hospital. It is also not uncommon
for nursing home residents to be sent to the hospital for evaluation in the emergency
room rather than being directed to a physician’s office where there are fewer resources to
deal with the many possible complications the residents may have or develop during
treatment. If the physician was aware of the extent of the resident’s contractures and
secondary pain, it would certainly not be unreasonable for him to conclude that
examination and treatment under anesthesia could be necessary, which could be more
safely done in the hospital rather than a physician’s office. Based on all the evidence, I
conclude that the simple removal of a foreign object from the resident’s vagina was
complicated by her comorbidity which necessitated treatment at the hospital rather than
the facility or a physician’s office. However, the fact removal was required in the
hospital, does not elevate the simple removal of a foreign object to the level of a
significant change in the resident’s condition. The simple removal of the foreign object,
though complicated by the resident’s comorbidity, did not require a significant change in
her treatment. The resident had previously been treated for a urinary tract infection with
antibiotics and the fact that she was given antibiotics again for a urinary tract infection
related to the foreign object and its removal does not mark a significant change in
treatment or show the recurrence of an infection.

Accordingly, I conclude that the evidence does not show a significant change in the
resident's physical, mental, or psychosocial status or a need to alter treatment
significantly within the meaning of 42 C.F.R. § 483.10(b)(11)(i) and there was no
violation of that regulation on August 9, 2007.

11. Petitioner did not violate 42 C.F.R. § 483.25, Tag F309, contrary to
the allegation of the August 14, 2007 revisit survey (Affirmed).

The surveyors allege in the SOD for the survey completed on August 14, 2007, that
Petitioner violated 42 C.F.R. § 483.25 and that the violation caused actual harm to
88

Resident 22. More specifically, the surveyors allege that Petitioner failed to ensure that
pain management interventions were consistently applied to effectively address Resident
22’s pain. The surveyors allege that on August 7, 8, 10, and 12, 2007, staff did not
administer pain medication or implement any other interventions when they assessed
Resident 22 as suffering pain at a level of four on a scale of zero to five, with five being
the worst pain. The surveyor’s allegations are that scheduled pain medication was given,
but pain medication ordered to be administered as needed was not administered. CMS
Ex. 63, at 8-14.

The regulation requires that:

Each resident must receive and the facility must provide the
necessary care and services to attain or maintain the highest
practicable physical, mental, and pyschosocial well-being, in
accordance with the comprehensive assessment and plan of
care.

42 C.F.R. § 483.25.

Surveyor Cheryl Bott testified that she drafted the deficiency citation under Tag F309 for
the survey that concluded on August 14, 2007. Tr. at 233; CMS Ex. 60, at 7. She
testified that Resident 22 was admitted to Petitioner’s facility on June 20, 2007, following
removal of a brain tumor, which left him with partial paralysis on his right side. She
testified that a pain assessment at admission showed that he could not verbalize the
location or level of his pain but he did have nonverbal signs of pain including
restlessness, fidgeting, pulling on his feeding tube, and crying. She testified that his
MDS dated July 3, 2007, assessed him as having short and long-term memory deficits;
severe cognitive impairment; total dependence for ADLs; repetitive physical movement;
restlessness; resistance to cares; and mild pain less than daily. His care plan reflected that
ie was not ambulatory; his speech was mumbled at times; and he required extensive
assistance for all ADLs. His care plan required Tylenol for pain as needed, assessment of
pain level every shift, to update the physician, and to provide one-to-one staff
intervention as necessary. The goal of the care plan for pain was that the resident be free
of pain. A new MDS done on July 24, 2007, assessed the resident as having a decline in
is behaviors related to repetitive verbalizations in addition to the continuing repetitive
physical movements and his pain was assessed as daily and moderate. The MDS
reflected the addition of an anti-anxiety medication. Surveyor Bott testified that she
observed the resident on August 14, 2007 and when she approached him and asked a
question his speech was garbled and he began to cry. She testified that according to the
resident’s records he was to have a Lidoderm patch for pain during the day and he was
also to receive Oxycodone four times each day. She testified that the resident also had
orders for Zoloft, beginning August 13, 2007, Seroquel, and Lorazepam. Tr. at 235-45.
She testified that Resident 22 had orders for Acetaminophen and Acetaminophen with

89

Codeine as needed for pain or elevated temp
order for Lorazepam was for administration

erature. Tr. at 250. She testified that the
as necessary for anxiety. Tr. at 251-53. She

testified that she cited the deficiency because Resident 22 was assessed on four

occasions, August 7, 8, 10 and 12, 2007, as

aving pain at a level of four on a five point

scale, pain she characterized as significant, but there is no evidence that staff used an

available pain medication or other interventi

ons to address the pain, but rather, elected to

wait until the next scheduled pain medication one and one-half hours later. She testified

that she concluded that Resident 22 suffered
agreed on cross-examination that the clinica!

actual harm as a result. Tr. at 277-79. She
records show that on both August 7 and 8

the treating physician was called by a nurse and reportedly opined that Resident 22 was

likely displaying increased agitation rather t

an pain and he prescribed an increase in

Seroquel on August 8. Tr. at 287-89, 298-99. She also acknowledged that she did not
know whether the resident’s crying when she asked him a question evidenced pain or

some other circumstance. She agreed that p

ysical displays such as fidgeting, crying, and

grimacing could be signs of pain, depression, or agitation, and she stated that she could
not understand the resident’s response to her question of whether or not he was

experiencing pain. Tr. at 291-94.

Dr. Kraus was also the treating physician for Resident 22. He testified that the resident
had a stroke following brain surgery that caused paralysis of his right arm and leg. He
testified he saw the resident at least once a month. When he first arrived at Petitioner’s
facility, Resident 22 was somnolent, minimally alert, with minimal ability to vocalize,

and easily agitated. He required tube feeding and had

evidence of altered cognition. Over time he
waking to his environment, with eye contact.
leg. Later he regained the ability to talk and
August 2007 survey. Resident 22 was frequi
aware of his surroundings around August 20!

brain injury or pain caused the agitation. He knew of

caused pain. However, the resident said the

speculated that there might be pain in the shoulder. H
retrospect he believes that the resident became more agitated when he

oulder. He did
consultant assiste

could not move his arm or s!
medication. A psychiatric c
concluded that the agitation

with the loss of use of his limbs rather than pain. Tr. at 472-80. He oj

decision of a nurse to provide an “as needed’
nursing practice, as he had discussed with st
indicated agitation rather than pain. He testi

medication as he was trying to determine whether the signs and symptoms
or agitation. He testified that the failure of a nurse to administer pain
not have caused more than minimal harm. Tr. at 481. Dr. Kraus testi

severe neurological deficits, and
showed improvement, he seemed to be

, and he gained some movement in his arm or
interact, but he believed that was after the
ently agitated as he was becoming more

07. There was a question about whether the
no trauma or injury that would have
word arm or shoulder and Dr. Kraus

owever he testified that in

realized that he
order pain medication and sedating

d to adjust the medication. However, he

was really related to his organic brain injury and frustration

that the

”’ pain medication was within the standard of
aff his belief that the signs and symptoms
fied that he did not cancel the order for pain
indicated pain
cation would
at he was

pined

medi
fied tl

reasonably certain that Resident 20 was suffering from agitation due to his anxiety or
90

frustration related to his paralysis rather than pain. Tr. at 501-02. The testimony of Dr.
Kraus is unrebutted and I find it fully credible and weighty.

Donna Elford, LPN, testified that on the occasions she rated Resident 22 as having pain
of four on a scale of one to five, and she did not administer the as needed pain medication
because she spoke with Dr. Kraus and he indicated that he believed the problem was
agitation not pain and he adjusted the resident’s psychotropic medication. Tr. at 629-33.
She testified that she misunderstood the surveyors to be asking her when she charted her
pain assessment rather than when she did the pain assessment. She testified that she
assessed pain when coming on shift and throughout the shift, but she charted the score at
the end of the day when she usually did her charting. She did not intend to suggest to the
surveyors that she only did a pain assessment at the end of her shift. Tr. at 634-35. She
testified on cross-examination that it is a matter of nursing judgment whether or not to
give medication ordered to be administered as necessary. Tr. at 646-48. The testimony
of LPN Elford is unrebutted and I find it fully credible and weighty.

The gist of the deficiency citation is that Petitioner’s staff violated the regulation and
caused actual harm to Resident 22 in the form of unrelieved pain during the morning shift
on four days, August 7, 8, 10, and 12, when LPN Elford assessed the resident as having
pain but she failed to deliver pain medication ordered to be given as necessary. CMS Ex.
63, at 10-12; CMS Ex. 72, at 31. The allegations are based upon a record review rather
than the surveyor witnessing the resident in pain. CMS argues that the evidence shows
that LPN Elford assessed Resident 22 as having level-four pain at 2:30 p.m. on each of
the four days but she decided not to give Resident 22 pain medication authorized to be
administered on an as needed basis because the resident was scheduled for pain
medication at 4:00 p.m. CMS Br. at 23. The CMS analysis of the evidence is in error.
The CMS view of the evidence is based in part upon a misunderstanding of the response
of LPN Elford to a question posed by Surveyor Bott during the survey related to when
LPN Elford assessed and/or recorded pain. LPN Elford’s testimony at trial is credible
and clarifies that she assessed pain of residents throughout her shift, but that she recorded
the highest level of pain observed during the shift at the end of her shift. Thus, the CMS
argument that Resident 22 suffered level-four pain on each of the four days from 2:30
p.m. until 4:00 p.m. is erroneous. It is not disputed however, that on each of the four
days, LPN Elford observed signs and symptoms consistent with pain that she assessed to
be at level-four but she elected not to give pain medication in addition to the pain
medication that had already been administered as scheduled. Consideration of the
clinical evidence is necessary.

When he was admitted to Petitioner’s facility on June 20, 2007, Resident 22 had an order
for Acetaminophen elixir every four hours as needed for pain or elevated temperature. P.
Ex. 3, at 3. On June 29, 2007, an order was issued for Morphine as needed for pain but
the drug was discontinued on July 3, 2007, because it caused a rash. P. Ex. 3, at 9. Dr.
Kraus’s progress note dated July 19, 2007, shows that Resident 22 appeared to have
91

discomfort of unknown etiology, when moving his right arm so the doctor ordered
Acetaminophen with Codeine elixir as needed for pain. P. Ex. 3, at 4, 11, 187. On July
24, 2007, a Lidoderm patch was ordered to be applied during the day for pain. P. Ex. 3,
at 12. On July 27, 2007, Tylenol 3 was scheduled for three times per day for pain. P. Ex.
3, at 4, 12. On August 3, 2007, Dr. Kraus discontinued the Tylenol 3 and ordered
Oxycodone every six hours. He also ordered a psychiatric evaluation and an x-ray of the
right arm and shoulder. P. Ex. 3, at 14. An order dated August 8, 2007 shows Dr. Kraus
increased the dose of Seroquel, an antipsychotic used to reduce agitation. P. Ex. 13, at
15. Resident 22 also had orders for Zoloft (an anti-depressant) and Lorazepam (Ativan)
(an anti-anxiety medication). CMS Ex. 72, at 27, 31; P. Ex. 3, at 1, 3, 8, 11.

A Nurse’s Notes entry dated August 3, 2007, shows that the x-ray of the resident’s right
upper extremity showed no fracture but that the resident did have arthritis in the arm. P.
Ex. 3, at 68; CMS Ex. 72, at 3. A Nurse’s Note late-entry on August 8, 2007 for August
7, 2007, states that Nurse Elford updated Dr. Kraus on a pain audit and that Dr. Kraus felt
that Resident 22’s non-verbal symptoms were really related to agitation and not pain and
that Resident 22 was to be monitored for changes. The Nurse’s Notes entries for August
8, 2007 state that Nurse Elford updated Dr. Kraus on her concerns for Resident 22’s
comfort and the doctor changed the afternoon dose of Seroquel but kept the morning dose
the same. CMS Ex. 72, at 6; P. Ex. 3, at 71. Nurse’s Notes entries by LPN Elford for
August 10 at 7:30 a.m. show that the resident was out of bed and went to the dining room
for breakfast where he ate 75 percent of his meal. At 11:20 a.m. on August 10 he was
reported to be in bed, very agitated, constantly moving his legs, rolling his body back and
forth, and pushing staff away, and he was given Ativan. At 1:00 p.m. on August 10,
Resident 10 was out of bed for lunch and he received a new bed. At 1:45 p.m. he was
back in bed rolling back and forth and pillows were placed under his mattress to keep him
from rolling out. A Nurse’s Notes late-entry by LPN Elford on August 12, 2007 for
August 11 indicates that when the resident was rolling back and forth on August 11 at
8:15 a.m. he was asked if he was in pain and he was given Tylenol with Codeine which
calmed him in about 30 minutes. Nurse’s Notes entries for LPN Elford on August 12,
2007 show that the resident was restless, tearful and sobbing at 7:00 a.m. and when asked
he stated that he could not move his arm. He was given Ativan and was comforted by
staff. At 8:15 a.m. the resident was reported to be calmer and was out of bed to go to
breakfast. An order to increase the resident’s Zoloft due to his increased crying episodes
was received at 3:30 p.m. The remainder of the notes for August 12, 2007, show that the
resident was calm and resting if not up for meals. P. Ex. 3, at 71-73; CMS Ex. 72, at 6-8.
Review of the Nurse’s Notes entries prior to August 3, 2007, reveals many instances of
reported anxiety and agitation. P. Ex. 3, at 45-70.

A Nurses’ Progress Note continuation sheet with an entry dated August 9, 2007, states
that Resident 22’s analgesic schedule was changed and that there was an on-going
evaluation of effectiveness with the physician being updated on frequency of agitation,
92

type of body movement, and calling out. The note also records that the right shoulder x-
ray showed no fracture or dislocation. P. Ex. 3, at 43.

The Nurse’s Notes entries for August 7, 8, 10, and 12, do not reveal any instance of
possible increased pain or anxiety to which LPN Elford and staff did not respond. On
August 7 and 8 the evidence is consistent with the testimony of Dr. Kraus and LPN
Elford that Dr. Kraus ordered a change in psychotropic medication. The change in
psychotropic medication is consistent with Dr. Kraus’s testimony that he suspected the
resident’s agitation was due to anxiety rather than pain and it is also consistent with the
evidence that there was an on-going plan to evaluate the effectiveness of the resident’s
analgesic regime. The Nurse’s Notes show that on August 10, 11, and 12, LPN Elford
and staff intervened to address signs of increased agitation and the interventions appear to
have been successful. The evidence shows that LPN Elford acted under guidance of Dr.
Kraus when she decided to implement interventions other than the administration of pain
medication ordered on an as needed basis. However, the decision not to administer as
needed pain medication is well within the discretion of the nurse, which is the purpose of
authorizing medication to be administered as needed. I note that the case of Resident 22
is significantly different from that of Resident 3 who was the subject of the same
deficiency citation from the June 27, 2007 survey. There is no evidence for Resident 22
that he had preexisting diagnoses that could be a cause of pain, unlike Resident 3 who
had three diagnoses that were possible sources of pain.

The regulation requires that a facility deliver necessary care and services for each
resident to attain or maintain the highest practicable physical, mental, and pyschosocial
well-being in accordance with the comprehensive assessment and plan of care for the
resident. Delivery of necessary care and services not only includes treating and
minimizing suffering from pain, it also requires constant assessment of whether there is
pain and the development and implementation of interventions necessary to control the
pain without negatively impacting the resident’s quality of life. In this case, the evidence
does not indicate a failure to deliver necessary care and services. Rather, the evidence
indicates that the physician and staff were working to assess the effectiveness of
interventions to control pain and anxiety to ensure that Resident 22 attained the highest
practicable physical, mental, and psychosocial well-being. Accordingly, I conclude that
Petitioner did not violate 42 C.F.R. § 483.25 as alleged by the August 14, 2007 revisit
survey and there is no basis for the imposition of an enforcement remedy.

12. The remedies proposed by CMS are not reasonable (On Remand).

13. Reasonable remedies are a $3,050 per day CMP from June 4
through June 13, 2007; a $200 per day from June 14 through August 2,
2007; a DPNA effective from July 20 through August 2, 2007, and
withdrawal of approval to conduct a NATCEP (On Remand).
93

a. Discussion From Original Decision

I have concluded that Petitioner was not in substantial compliance with program
participation requirements from June 4 through August 2, 2007, due to violations of 42
C.F.R. §§ 483.25, 483.25(c), and 483.25(i)(1). I have concluded that the violations of 42
C.F.R. §§ 483.25(c) and 483.25(i)(1) posed immediate jeopardy from June 4 through
June 13, 2007, while the violation of 42 C.F.R. § 483.25 caused actual harm.*° My
conclusion that there was immediate jeopardy from June 4 through June 13, 2007,
requires that any CMP imposed for that period be in the upper range of authorized CMPs.
The continuing violation of these regulations after the immediate jeopardy was abated
and until Petitioner returned to substantial compliance with program participation
requirements on August 3, 2007, is a sufficient basis for imposition of a CMP in the
lower range in the amount of $200 as proposed by CMS. Therefore, for purposes of
assessing a reasonable remedy, I need not consider the non-immediate jeopardy
deficiencies cited by the June 27, 2007 survey.

In its letter dated July 10, 2007, CMS proposed a CMP of $8,800 per day for ten days
from June 4 through June 13, 2007. CMS based the proposed CMP on the understanding
that the state agency had cited four violations at an immediate jeopardy level. I have
concluded the determination of immediate jeopardy was clearly erroneous for Tag F309
and that there was no deficiency under Tag F224 and no associated immediate jeopardy.
Accordingly, I conclude that a CMP at a rate of $8,800 per day for the ten days from June
4 through June 13, 2007 is unreasonable and I must determine a reasonable CMP for the
period of June 4 through June 13, 2007.

I must determine a reasonable CMP by considering the factors listed in 42 C.F.R. §
488.438(f): (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. The factors in 42 C.F.R.
§ 488.404 include: (1) the 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. In reaching a decision on the reasonableness of the CMP, I consider

36 T did not make the finding as a substitute for the surveyor’s scope and severity
determination but rather to reflect the seriousness of the deficiency, a finding that is
required when assessing the reasonableness of the enforcement remedies proposed. 42
C.F.R. §§ 488.404(b), 488.438(e) - (f).
94

whether the evidence 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 above factors. 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. Barn Hill Care Ctr., DAB No. 1848, at 21 (2002);
Community Nursing Home, DAB No. 1807, at 22 (2002); Emerald Oaks, DAB No. 1800,
at 9; CarePlex of Silver Spring, DAB No. 1638, at 8 (1999).

Petitioner produced credible oral testimony from Martin Metten, executive vice president
and chief financial officer of Heyde Companies which owns and operates the facility.
The unrebutted evidence shows that Petitioner’s financial condition is poor and that the
imposition of a large CMP would likely put Petitioner out-of-business. Tr. at 878-86. I
consider Mr. Metten’s oral testimony in determining a reasonable CMP to impose against
Petitioner. I have considered evidence of Petitioner’s prior history of noncompliance. I
have considered Petitioner’s culpability regarding its deficiencies related to Resident 3.
Based on my consideration of all the required factors in the context of this case, I
conclude that reasonable remedies are: a $3,050 per day CMP from June 4 through June
13, 2007; a $200 per day CMP from June 14 through August 2, 2007; a DPNA effective
July 20 through August 2, 2007; and a withdrawal of authority to conduct a NATCEP for
two years from June 27, 2007 through June 26, 2009, based on substandard quality of
care and the fact that a CMP of over $5,000 has been assessed against Petitioner.

b. Additional Discussion Following Remand

The Board expressed concern in the remand decision that I had not sufficiently
articulated the basis for my reduction of the CMP for the period June 4 through June 13,
2007 from $8,800 per day to $3,050 per day, which is the least amount authorized when
there is immediate jeopardy. The reduction in the total amount of the CMP for the period
June 4 through June 13, 2007, due to the change from $8,800 to $3,050 per day, was
$57,500. I found the remaining enforcement remedies for the period of noncompliance
reasonable, including a $200 per day CMP for June 14 through August 2, 2007, a DPNA
effective July 20 through August 2, 2007, and ineligibility to conduct a NATCEP,
reasonable. My reading of the Board’s remand decision is that the remedies I found
reasonable with no change require no further analysis. Thus, my additional analysis is
limited to the CMP in the upper range for the period June 4 through 13, 2007.

The analysis in my original decision was intentionally brief and as comprehensive as I
believed necessary. Although I did not discuss all the relevant evidence, I certainly was
aware and considered Petitioner’s prior history of noncompliance to the extent it was

95

supported by evidence in the record or prior decisions of the Board*” and argued by
CMS. CMS Prehearing Brief at 46-49; CMS Brief at 24-29; CMS Reply at 28-30. I
clearly considered the severity of the noncompliance, the relationship of the instances of
noncompliance and the facts as they related to Resident 3, all of which is reflected under
the discussion of the various tags. I specifically mentioned in my original analysis that I
considered that I found the evidence proved fewer instances of noncompliance that posed
immediate jeopardy than CMS presumably considered when the decision was made to
impose an $8,800 per day CMP. | also stated that I specifically considered whether a
CMP of lesser amount fulfilled the Congressional purpose for authorizing the Secretary
to impose CMPs. I considered the evidence of potential financial hardship posed by the
additional penalty totaling $57,500 credible as it was unrebutted and I had no basis to
discount the sworn testimony of Mr. Metten.

My authority to review the reasonableness of the CMP is limited by 42 C.F.R. §
488.438(e). The limitations are: (1) I may not set the CMP at zero or reduce it to zero;
(2) I may not review the exercise of discretion by CMS in selecting to impose a CMP;
and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when
determining the reasonableness of the CMP amount. In determining whether the amount
of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be
considered: (1) the facility’s history of non-compliance, including repeated deficiencies;
(2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at
42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when
setting the CMP amount; and (4) the facility’s degree of culpability, including but not
limited to the facilities neglect, indifference, or disregard for resident care, comfort, and
safety and the absence of culpability is not a mitigating factor. The factors that CMS and
the state were required to consider when setting the CMP amount and that I am required
to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. §
488.404(b): (1) whether the deficiencies caused no actual harm but had the potential for
minimal harm, no actual harm with the potential for more than minimal harm, but not
immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy
to resident health and safety; and (2) whether the deficiencies are isolated, constitute a
pattern, or are widespread. My review of the reasonableness of the CMP is de novo and

37 Columbus Nursing and Rehab. Ctr., DAB No. 2273 (2009) (Board affirmed ALJ
decision that Petitioner was noncompliant with requirements for the prevention and care
of pressure sores and noncompliance posed immediate jeopardy); Columbus Nursing and
Rehab. Ctr., DAB No. 2247 (2009) (Board affirmed ALJ decision that Petitioner failed to
thoroughly investigate and report abuse or neglect; failed to protect residents during
investigation; and failed to implement its abuse and neglect policy and noncompliance
posed immediate jeopardy).
96

based upon the evidence in the record before me. I am not bound to defer to the CMS
determination of the reasonable amount of the CMP to impose but my authority is limited
by regulation as already explained. I am to determine whether the amount of any CMP
proposed is within reasonable bounds considering the purpose of the Act and regulations.
Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683,
at 14-16 (1999); Capitol Hill Community Rehab. and Specialty Care Ctr., DAB No. 1629
(1997). The regulations do not specify how the ALJ is to weigh each of the regulatory
factors but leave that determination to the discretion of the ALJ.

Before addressing the relative weighing of factors, I address issues raised by the Board
related to the evidence of financial condition in this case. There is no issue that Petitioner
bears the burden of persuasion by a preponderance of the evidence that its financial
condition impacts its ability to pay according to prior decisions of the Board. The
regulation requires that in determining the amount of the CMP, CMS and the state must
consider the facility’s financial condition. 42 C.F.R. § 488.438(f)(2). Iam also required
to consider financial condition when conducting my de novo review of the reasonableness
of the CMP. The requirement to consider financial condition is a requirement imposed
by section 1128A(d) of the Act. The Act and regulation do not specify a point in time
that is relevant and must be used for assessing the facility’s financial condition. The
drafters of the regulation stated:

Response: As stated above, it is a statutory requirement that a
facility's financial condition be considered as a factor to
determine the amount of the civil money penalty. We do not
specify in the regulation what we will examine in
determining the facility’s financial condition, because
these factors are unique for each facility. Therefore, it is
the responsibility of the facility to furnish the information it
believes appropriately represents its financial status. We
consider a facility's financial condition in conjunction with
the other factors specified in the rule when determining the
amount of a civil money penalty, because it is not our intent
to put facilities out of business, and the amount of the civil
money penalty is determined on a case by case basis.

59 Fed. Reg. 56,116, 56,205 (Nov. 10, 1994). Thus, the drafters of the regulation
intentionally did not specify that some evidence of financial condition may be more
relevant or probative than other evidence or specify that only evidence of financial
condition at the time of the CMS determination is relevant. A CMP may not be
collected until final administrative review is complete and it is only then that the
financial impact of the CMP will affect the facility. 42 C.F.R. § 488.442(a). Thus, it is
more consistent with the requirement to consider financial condition to consider
financial condition at each stage when the financial condition must be considered rather
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than only at the point in time when CMS determined to propose a CMP. I find no legal
basis to limit the review to which Petitioner is entitled under the section 1128A(d) of the
Act to only that evidence of financial condition at the time CMS determined to impose a
CMP. The Board requested that I address whether CMS gave adequate notice of its
objection to the relevance of testimony about Petitioner’s financial condition after the
date on which CMS proposed the CMP. Columbus Nursing and Rehab. Ctr., DAB No.
2398, at 18. The CMS objection was timely and could not be expected until such time
as Mr. Metten actually began to testify as to what CMS perceived to be objectionable
matters. The CMS objection was overruled at hearing and Mr. Metten was permitted to
testify but CMS was advised that it could raise the issue in post-hearing briefing where
the objection could be more fully addressed by both parties. If not already apparent, I
conclude that the CMS objection is without merit and was correctly overruled at hearing
for the reasons discussed above.

The Board comments that it has in prior cases permitted an ALJ to disregard testimony
regarding financial condition where the facility failed to also submit documentation in
support of the testimony. Columbus Nursing and Rehab. Ctr, DAB No. 2398, at 17. It
is not clear to me whether or not the Board is suggesting that it is unwilling to consider
testimonial evidence regarding financial condition absent documents to bolster the
testimony.** However, I conclude that it would be an abuse of my discretion in this case
to disregard the testimony offered regarding financial condition. The Act requires
consideration of financial condition before a CMP may be imposed and collected. The
regulation includes the same requirement. Neither the Act nor the regulations specify
the form of the evidence that must be considered or rule out consideration of testimonial
evidence as to financial condition. In this case, there is no dispute that CMS did not
attempt to rebut the testimony. The CMS cross-examination was ineffective in creating
any concern about the truth and veracity of Martin Metten or the credibility of the
evidence he provided. Petitioner listed Mr. Metten on its June 17, 2008 list of witnesses
and specifically stated that Mr. Metten would testify about Petitioner’s financial ability
to pay the proposed CMP. Despite the advance notice, CMS was not prepared at hearing
to question Mr. Metten with or introduce as rebuttal evidence any evidence related to
Petitioner’s financial condition at the time of hearing based on information available to
CMS (see e.g. SOM § 7516; Tr. at 889; CMS Ex. 5). Mr. Metten testified under oath
subject to cross-examination by the government. Mr. Metten was in a position to know

38 No adverse inference should be drawn from Petitioner’s failure to submit documents
as there was no motion for production of such documents by CMS, and no grounds to
sanction Petitioner by drawing such an inference. Act § 1128A(c)(4). Although CMS
may take the position that it is prohibited from requesting such production by its own
regulations, such a prohibition is clearly not consistent with section 1128A of the Act.
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and understand the financial condition of Petitioner’s owner and operator, Heyde Health
System Columbus, LLC, as its vice-president and chief operating officer. Tr. at 877-78.
Mr. Metten’s credible testimony was that in 2007 and 2008, Petitioner had a combined
net operating loss of approximately $830,000 (Tr. at 878), $670,000 in 2007 and
$160,000 in 2008 (Tr. at 883-84); Petitioner’s census of residents declined from an
average of 65 in 2006 to the mid-50s in 2007, and to the mid-40’s in 2008 (Tr. at 881-
82); Petitioner’s cash position was worse at the time of hearing than when CMS
proposed the CMP (Tr. at 884); Petitioner does not own the real estate on and in which it
operates (Tr. at 887); Petitioner did report a profit in 2005 and an insignificant loss in
2006 (Tr. at 889); average monthly gross revenues were $400,000 (Tr. at 890);
Petitioner’s total assets amounted to $700,000 to $800,000 (Tr. at 890); Petitioner had
no access to credit at the time (Tr. at 891); Petitioner had no cash available at the time of
hearing (Tr. at 897); Petitioner was having difficulty making its payroll and paying
vendors (Tr. at 897-98); Medicare revenue was insufficient to cover operating costs (Tr.
at 898); and Petitioner had a negative net worth at the time of hearing (Tr. at 900). The
gist of Mr. Metten’s testimony was that given the Petitioner’s financial condition at the
time of hearing, the payment of any CMP would have a significant negative financial
impact upon Petitioner. CMS Ex. 5 confirms that Petitioner reported a net loss of
approximately $185,000. CMS Ex. 5 also shows that in 2006 Petitioner reported total
assets of $706,890 and total liabilities of $706,890, of which $393,025 was owner equity
and current liabilities of $313,865, none of which is inconsistent with Mr. Metten’s
testimony. I conclude based on all the evidence that Mr. Metten’s testimony was
relevant, credible, and unrebutted by CMS. I conclude that the evidence shows that it is
more likely than not that the imposition and collection of any CMP, specifically a CMP
totaling $57,500 more than I found reasonable in my initial decision, would have a
significant adverse impact upon Petitioner’s ability to continue in business. Petitioner
has met its burden to show by a preponderance of the evidence its financial condition
and that its financial condition would be adversely impacted by a CMP.

I weighed and considered the factors the Board questioned as follows:
© Seriousness and Relationship of the Deficiencies

The noncompliance under Tag F314 and F325 was serious and posed immediate
jeopardy. The noncompliance under Tag F309 was also serious as it caused actual harm
to Resident 3. The three deficiencies all relate to the care and treatment of Resident 3 but
I do not consider the fact that the impact was upon one resident as a mitigating factor.
The authorized CMP must be in the upper range of authorized CMPs during the period
June 4 through 13, 2007, due to the existence of immediate jeopardy.

I also note that Petitioner was culpable for its noncompliance related to Resident 3.
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 Petitioner’s Financial Condition

The evidence of Petitioner’s financial condition supports my conclusion that imposing a
total CMP of $57,500 more than I found reasonable in my initial decision, would have
had a serious negative impact upon Petitioner’s ability to pay staff and vendors, to the
extent that Petitioner could no longer sustain business operations.

e History of Noncompliance and Other Factors

I have carefully considered the Board’s prior decisions in cases involving Petitioner and
the Boards prior affirmances of immediate jeopardy-level noncompliance and
substandard quality of care. The decisions are available on the Board’s website.
Columbus Nursing and Rehab. Ctr., DAB No. 2273 (2009) (Board affirmed ALJ decision
that Petitioner was noncompliant with requirements for the prevention and care of
pressure sores and the noncompliance posed immediate jeopardy); Columbus Nursing
and Rehab. Ctr., DAB No. 2247 (2009) (Board affirmed ALJ decision that Petitioner
failed to thoroughly investigate and report abuse or neglect; failed to protect residents
during investigation; and failed to implement its abuse and neglect policy and the
noncompliance posed immediate jeopardy). I conclude in this decision that Petitioner
was noncompliant with 42 C.F.R. § 483.25(c) related to prevention and treatment of
pressure sores and that the noncompliance posed immediate jeopardy. The Board
affirmed the same citation of noncompliance at the immediate jeopardy-level in DAB No.
2273, and I clearly recognize similarity between the two citations. I also recognize that
in the prior cases as in this case, Petitioner was not terminated but was determined by
CMS to have returned to substantial compliance with program participation requirements,
thereby satisfying the statutory purpose for enforcement remedies at the time. I have also
considered that the remedies imposed in the prior cases were insufficient to ensure that
Petitioner maintained compliance with program participation requirements. However, at
the time of the hearing in this case Petitioner had been found to have returned to
substantial compliance once again.

e Relative Weight of the Factors and Impact Upon the
Amount of the CMP Approved

The regulation sets a floor of $3,050 for a per day CMP for noncompliance that poses
immediate jeopardy. 42 C.F.R. § 488.438(a)(1)(i). I am not bound by the CMS proposed
CMP of $8,800 per day and may not inquire as to the CMS decision-making regarding
the imposition of a CMP or its amount. Rather, I must do a de novo review. Petitioner’s
culpability and history of noncompliance including the repeated noncompliance related to
pressure sores supports an increased amount above the $3,050 floor for immediate
jeopardy noncompliance. The noncompliance was serious but the fact that the
noncompliance posed immediate jeopardy compels a CMP in the upper range of
authorized CMPs and I decline to further escalate the amount of the CMP by considering
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seriousness twice in this case. The surveyors cited the immediate jeopardy
noncompliance as being isolated, a characterization with which I agree. The additional
factor for consideration in this case is evidence of Petitioner’s unfavorable financial
condition at the time of hearing.

There are no formulas provided by the regulation or the Act for weighing the factors.
Rather, the weighing of the factors is a matter left to the discretion of the ALJ, who is
bound to follow the Act and regulations and ensure the law is applied consistent with the
intent of Congress. In this case Petitioner returned to substantial compliance and the
purpose for imposing an enforcement remedy was achieved. Considering only
Petitioner’s history of noncompliance, the seriousness of the noncompliance in this case,
and Petitioner’s culpability, I would not hesitate to impose a daily CMP at the maximum
amount of $10,000 per day. However, given the evidence of Petitioner’s financial
condition, I conclude that a CMP of no more than $3,050 per day is reasonable for the
period of June 4 through 13, 2007.

III. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance
with program participation requirements from June 4, 2007 through August 2, 2007, due
to violations of 42 C.F.R. §§ 483.25, 483.25(c), and 483.25(i)(1). Reasonable
enforcement remedies are: a $3,050 per day CMP from June 4 through June 13, 2007, a
$200 per day CMP from June 14 through August 2, 2007, a DPNA to be imposed from
July 20 through August 2, 2007, and withdrawal of authority to conduct NATCEP for
two years.

/s/
Keith W. Sickendick
Administrative Law Judge