Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Envoy of Stratford Hills
(CCN: 49-5223),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-15-3317
Decision No. CR4735

Date: November 10, 2016

AMENDED DECISION

Envoy of Stratford Hills (Envoy or Petitioner) challenges the Centers for Medicare &
Medicaid Services’ (CMS) determination that it was not in substantial compliance with
multiple Medicare program participation requirements on July 9, 2015, and for six
months prior to that date. Based on Envoy’s failure to be in substantial compliance, CMS
imposed a per-day civil money penalty (CMP) from June 11, 2015, through July 7, 2015,
and terminated Petitioner’s Medicare provider agreement on July 8, 2015. Envoy
challenges the CMS remedies. For the reasons discussed below, | affirm CMS’s
determination.

I. Background

The Social Security Act (Act) sets forth requirements for a skilled nursing facility’s
(SNF’s) participation in the Medicare program and authorizes the Secretary of Health and
Human Services (the Secretary) to promulgate regulations implementing those statutory
provisions. Act § 1819; 42 U.S.C. § 1395i-3. The Secretary’s regulations are found at
42 C.F.R. Parts 483 and 488. To participate in the Medicare program, an SNF must
maintain substantial compliance with program participation requirements. To be in
substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident
health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301.
“Noncompliance” means “any deficiency that causes a facility to not be in substantial
compliance.” Jd.

The Secretary contracts with state agencies to conduct periodic surveys to determine
whether SNFs are in substantial compliance. Act § 1864(a), 42 U.S.C. § 1395aa(a);

42 C.F.R. § 488.10. The Act also authorizes the Secretary to impose enforcement
remedies against SNFs that are not in substantial compliance with the program
participation requirements. Act § 1819(h), 42 U.S.C. § 1395i-3(h). An SNF found not to
be in substantial compliance is subject to one or more enforcement remedies, including
termination. Jd.; 42 C.F.R. §§ 488.402, 488.406, 488.408.

A per-day CMP may range from either $50 to $3,000 per-day for less serious
noncompliance, or $3,050 to $10,000 per-day for more serious noncompliance that poses
immediate jeopardy to the health and safety of residents. 42 C.F.R. § 488.438(a).
“Immediate jeopardy” exists when “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. The authorized range for a
per-instance CMP is $1,000 to $10,000. 42 C.F.R. § 488.438(a)(2).

The statute authorizes the Secretary to terminate a provider agreement if she finds
substantial noncompliance with program requirements whether or not CMS has
determined that the noncompliance poses immediate jeopardy. Act § 1819(h)(2),

42 U.S.C. § 1395i-3(h)(2); Act § 1866(b)(2)(A), 42 U.S.C. § 1395cc(b)(2)(A); 42 C.F.R.
§ 488.412; see also Shalala vy. Ill. Council on Long Term Care, Inc., 529 U.S. 1, 21
(2000). CMS must terminate the provider agreement of an SNF that has been out of
substantial compliance for more than six months, even if the noncompliance only
involves one Medicare participation requirement. See 42 C.F.R. § 488.412; see also Act
§ 1819(h)(2)(C), 42 U.S.C. § 1395i-3(h)(2)(C).

If CMS imposes a remedy, including termination, based on a noncompliance
determination, then the facility may request a hearing before an administrative law judge
(ALJ) to challenge the noncompliance finding and enforcement remedy. Act

§ 1128A(c)(2), 42 U.S.C. § 1320a-7a(c)(2); Act § 1819(h)(2)(B)(ii), 42 U.S.C.

§ 1395i(h)(2)(B)(ii)); Act § 1866(h)(1), 42 U.S.C. § 1395ce(h)(1); 42 C.F.R.

§§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13), 498.5(b). The hearing before an ALJ is
a de novo proceeding. CarePlex of Silver Spring, DAB No 1683 (1999) (holding that
ALJs hold de novo hearings based on issues permitted under the regulations and ALJ
review is not a quasi-appellate review); see also Claiborne-Hughes Health Ctr. v.
Sebelius, 609 F.3d 839, 843 (6th Cir. 2010) (The DAB “reviewed the finding under the
de novo standard that the ALJ would have applied.”). A facility has a right to appeal a
“certification of noncompliance leading to an enforcement remedy.” See 42 C.F.R.

§ 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e), 498.3. However, CMS’s choice of
remedies and the factors CMS considered when choosing remedies are not subject to
review. 42 C.F.R. § 488.408(g)(2).

In regard to the burden of proof, CMS must make a prima facie case that the SNF failed
to comply substantially with federal participation requirements and, if this occurs, an
SNF must, in order to prevail, prove substantial compliance by a preponderance of the
evidence. Hillman Rehab. Ctr., DAB No. 1611, at 8 (1997); see Batavia Nursing &
Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB
No. 1904 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr.,
DAB No. 1665 (1998).

Envoy was an SNF located in Richmond, Virginia, that participated in the Medicare
program. The Virginia Department of Health, Office of Licensure and Certification (state
agency) performed an annual standard survey of Envoy on January 8, 2015. Based on the
survey findings, CMS found Petitioner not in substantial compliance with Medicare
program requirements as of January 8, 2015. CMS Exhibits (Exs.) 1-9. The state agency
conducted a subsequent revisit survey on March 2, 2015; however, the state agency found
that Petitioner was still not in substantial compliance. CMS Ex. 10.

In a March 17, 2015 letter, CMS imposed on Petitioner a denial of payment for new
admissions (DPNA) beginning April 8, 2015, based on the January and March

surveys. CMS Ex. 29 at 2. In an April 6, 2015 letter, CMS imposed a CMP based on the
January and March surveys of $5,150 per-day beginning February 6, 2015, through
February 24, 2015, and $750 per-day thereafter. Petitioner (P.) Ex. 2 at 3. The state
agency conducted another revisit survey on April 30, 2015, which resulted in findings of
a continued failure to substantially comply with Medicare program requirements. CMS
Ex. 13.

The state agency later conducted two more subsequent revisit surveys on June 11, and

July 9, 2015, both of which found a failure to be in substantial compliance with Medicare
participation requirements. CMS Exs. 17,21. The deficiencies found during the June 11,
2015 survey were:

© 42 C.F.R. § 483.15(e)(1), (F246 — quality of life: accommodation of needs)
at the scope and severity (s/s) level D (isolated instance of noncompliance
that causes no actual harm with the potential for more than minimal harm);

e 42 C.F.R. § 483.25, (F309 — quality of care) at the s/s level D;

e 42C.F.R. § 483.25(e)(2), (F318 — quality of care: range of motion) at the
s/s level D;
CMS Ex. 17.

42 C.F.R. § 483.25(g)(2), (F322 — quality of care: naso-gastric tubes) at the
s/s level D;

42 C.F.R. § 483.25(k), (F328 — quality of care: special needs) at the s/s
level D;

42 C.F.R. § 483.25(m)(2), (F333 — quality of care: medication errors) at
the s/s level D; and

42 C.F.R. § 483.65, (F441 — infection control) at the s/s level D.

The deficiencies found during the July 9, 2015 survey were:

CMS Ex. 21.

is

2 C.F.R. § 483.10(b)(11), (F157 — resident rights: notice of rights and
services, notification of changes) at the s/s level D;

42 C.F.R. § 483.20(k)(3)(i), (F281 — resident assessment: comprehensive
care plans) at the s/s level E (pattern of noncompliance that causes no actual
harm with the potential for more than minimal harm);

is

2 C.F.R. § 483.25, (F309 — quality of care) at the s/s level D;

is

2 C.F.R. § 483.25(k), (F328— quality of care: special needs) at the s/s
level D;

42 C.F.R. § 483.25(/), (F329- quality of care: unnecessary drugs) at the s/s
level D;

is

2 C.F.R. § 483.40(b)(4), (F386— physician services: physician visits) at
the s/s level D;

is

2 C.F.R. § 483.65, (F441— infection control) at the s/s level D;

42 C.F.R. § 483.75(g), (F499- administration: staff qualifications) at the
/s level D; and

2

42 C.F.R. § 483.75(/)(1), (F514— administration: clinical records) at the s/s
level D.
Based on these surveys, CMS continued the $750 per-day CMP through July 7, 2015. P.
Ex. 5 at 1. CMS also terminated Petitioner’s participation in the Medicare program
effective July 8, 2015. P. Ex. 4 at 1-3.

Petitioner timely requested a hearing before an ALJ to dispute CMS’s findings.
Following receipt of Petitioner’s hearing request, I issued an Acknowledgment and Initial
Prehearing Order. In that order, I directed the parties to file written direct testimony for
all witnesses they wanted to present.

CMS filed a prehearing brief (CMS Br.) and 44 proposed exhibits (CMS Exs. 1-44),!
including the written direct testimony for 11 witnesses.” Petitioner filed a prehearing
brief (P. Br.) and 41 proposed exhibits (P. Exs. 1-40),° including the written direct
testimony for eight witnesses. Both parties asked to cross-examine all of the opposing
party’s witnesses. I admitted CMS Exhibits 1 through 44 and Petitioner’s Exhibits 1
through 40.

Petitioner stipulated that CMS’s determinations related to the January 8, 2015 and March
2, 2015 surveys are final, and Petitioner withdrew its appeal related to the April 30, 2015
survey. Petitioner’s Proposed Stipulations of Fact and Statements of Issues Presented for
Hearing fj 10, 20. Petitioner does not dispute the January, March, or April surveys, or
the remedies associated with this noncompliance, namely - $5,150 per-day beginning
February 6, 2015, through February 24, 2015, and $750 per-day from February 25, 2015,
through June 11, 2015. Accordingly, the determinations and associated remedies related

1 By Order dated November 4, 2015, I admitted CMS Exhibits 1 through 41 and 43, and
Petitioner’s Exhibits 1 through 40. Although CMS listed CMS Exhibit 42 (“Excerpt for
State Operations Manual, Appendix PP, Interpretive Guidelines Regarding F-333”) on its
final exhibit list, it did not submit the exhibit. However, on November 5, CMS submitted
CMS Ex. 42 and added a new exhibit, CMS Ex. 44. Furthermore, on November 6, CMS
filed a clean copy of CMS Ex. 22 part E. During the hearing on November 9, 2015, I
admitted CMS Exs. 42 and 44 and the clean copy of CMS Ex. 22 part E. Tr. 11/9 at 14.

2 CMS submitted CMS Ex. 43 on October 5, 2015. This exhibit is the written direct
testimony of Marilyn Dayton, RN. On October 28, 2015, CMS submitted a revised
version of CMS Ex. 43. In my November 4, 2015 Order, I admitted CMS Ex. 43 as
revised. However, during the hearing, Petitioner’s counsel questioned Ms. Dayton
concerning the October 5 version of CMS Ex. 43, which I then admitted in addition to the
revised version of that exhibit. Tr. 11/10 at 14. I note that the hearing transcript
incorrectly identified the October 5 version of CMS Ex. 43 as Petitioner Exhibit 43. All
references in the rest of this decision to CMS Ex. 43 are to the revised version of that
exhibit submitted on October 28 and admitted on November 4.

> Petitioner submitted exhibits marked 17 and 17A.
to the January 8, March 2, and April 30, 2015 surveys are administratively final and not
before me.

Petitioner asserts that it returned to substantial compliance by June 2, 2015, and disputes
all of the deficiencies found in the June 11, 2015 and July 9, 2015 surveys, the associated
CMP of $750 per-day from June 11, 2015, through July 7, 2015, the imposition of a
DPNA on April 8, 2015, and its termination effective July 8, 2015.

On November 9, 10, and 18, 2015, I held a video hearing.* I heard testimony on cross-
examination on behalf of CMS from: CMS nurse consultant, Linda Brown, R.N. (CMS
Ex. 41 at 15-18); CMS surveyor and nurse consultant, Gerald Hahn, R.N. (CMS Ex. 41 at
19-22); state agency surveyor, Celinda Lovett, R.N., M.P.A. (CMS Ex. 41 at 39-41); state
agency surveyor, Shyrn Nyarko, Ph.D., LCSW (CMS Ex. 41 at 30-34); state agency
surveyor supervisor, Elaine Cacciatore, R.N. (CMS Ex. 41 at 51-57); state agency
surveyor, Raymond R. Polakoski, R.N. (CMS Ex. 41 at 58-70); state agency surveyor,
Meghan Garret, R.D., M.S. (CMS Ex. 41 at 35-38); state agency surveyor, Marilyn
Dayton, R.N. (CMS Ex. 43); state agency surveyor, Joyce Wilburn, R.N. (CMS Ex. 41 at
42-50); state agency surveyor, Rose M. Trevilian, R.N. (by telephone) (CMS Ex. 41 at
23-29); and CMS medical expert, Jefferson Lesesne, M.D. (CMS Ex. 41 at 1-14). [heard
testimony on cross-examination on behalf of Petitioner from: Petitioner’s maintenance
Director, Johnny Wimmer (P. Ex. 35); Petitioner’s charge nurse, Tammy Springer,
L.P.N., (Ex. 37); Petitioner’s Medical Director, James Thompson, M.D. (P. Ex. 38);
Petitioner’s regional director of nutrition services, Diana Bruen, R.D., MLS., C.S.G. (P.
Ex. 36); Petitioner’s administrator, Stacie Shive, NHA, (P. Ex. 34); a nurse employed by
Petitioner, Kimberly Christian, L.P.N. (P. Ex. 40); Petitioner’s regional nurse consultant,
Melinda Hirn, R.N. (P. Ex. 33); and Petitioner’s corporate compliance nurse, Marilyn
Nalley, R.N., (P. Ex. 39).

After the hearing, CMS and Petitioner filed post hearing briefs (CMS Post-Hrg. Br. and
P. Post-Hrg. Br.) and post hearing reply briefs (CMS Reply and P. Reply). With its post
“Attachment 1,” and later as P. Ex. 42, which is a November 18, 2015 letter to Petitioner
from the state agency stating that after the Informal Dispute Resolution (IDR) review,*
CMS determined that all deficiencies would remain as originally written. Later,
Petitioner also filed a motion to supplement the record with a document marked as P. Ex.

* A transcript was prepared for each day of the hearing. The transcripts for November 10
and 18 were not marked with continuous pagination from the prior date’s hearing.
Accordingly, I will refer to the transcripts by the date of the hearing in which they
correspond: Tr. 11/09, Tr. 11/10, or Tr. 11/18.

> SNFs have the right to request informal dispute resolution regarding survey findings.
42 CFR. § 488.331.
41, an internal October 20, 2015 IDR recommendation from the state ALJ who held the
IDR conference. Petitioner asserted that I should enter into the record proposed P. Ex. 41
and P. Ex. 42. Petitioner argued the following for inclusion in the record: these
documents were not available prior to the hearing; the findings of the IDR undercut the
testimony of CMS’s witnesses; the IDR recommendations to delete deficiencies, which
CMS has not expressly rejected, may be considered dispositive as to those deficiencies;
and these documents are necessary for a complete and clear administrative record. P.
Motion to Supplement at 3. CMS objects to both P. Exs. 41 and 42 as untimely and
irrelevant, pointing out that P. Ex. 42 shows that CMS rejected the IDR recommendations
and that the state ALJ did not consider all of the evidence that is in the record in this
proceeding; CMS requested that I either exclude the proposed exhibits or give them no
weight. CMS Objection to P. Motion to Supplement. I agree with Petitioner that I
should admit P. Exs. 41 and 42 into the record to ensure a complete administrative
record; however, I view these documents as procedural and not substantive exhibits. I
interpret P. Ex. 42 as CMS’s rejection of all of the IDR recommendations (P. Ex. 42);
therefore, P. Ex. 41 does not affect my adjudication of this case, which is de novo.
Britthaven of Chapel Hill, DAB No. 2284 at 5-9 (2009).

IL. Issues
1. Whether CMS had a basis to terminate Envoy’s Medicare provider agreement
for failing to be in substantial compliance with Medicare program participation
requirements on July 9, 2015, and for six months before that date;
2. Whether CMS had a basis to impose a per-day CMP on Envoy from June 11,
2015, through July 7, 2015, due to Envoy’s failure to be in substantial

compliance with Medicare program participation requirements; and

3. IfCMS had a basis for imposing a per-day CMP on Envoy from June 11, 2015
through July 7, 2015, whether the amount of CMP imposed is reasonable.

Ill. Findings of Fact

June 11, 2015 survey:

1. Resident 312° (R312) is male and was born on September 14, 1964. P. Ex. 18 at
1.

2. Petitioner admitted R312 to its facility on June 3, 2014, with an admitting
diagnosis that included diabetes. P. Ex. 18 at 1-2.

® To ensure their privacy, I do not refer to the residents by their names. Instead, I refer to
the residents by the resident identifier number that they are assigned for each survey.
10.

11.

12.

By November 2014, R312 had an extensive regimen to treat his diabetes,
including: a rapid-acting insulin, Novolog, at 6:30 AM and 4:30 PM (units were
based on a sliding scale dependent on his blood glucose levels); 30 units of a
long-acting insulin, Levemir, at 9 AM; 30 units of an intermediate-acting insulin,
Novolin, at 9 AM and 20 units at9 PM. P. Ex. 18 at 5.

Before June 2, 2015, R312 experienced complications due to his diabetes,
including coronary artery disease, peripheral vascular disease, and left foot
osteomyelitis. CMS Ex. 18 Part D at 33-34; CMS Ex. 41 at 6; P. Ex. 18 at 1-3.

On June 2, 2015, Dr. Thompson, Petitioner’s medical director, determined that
R312’s type 2 Diabetes Mellitus was “poorly controlled” and changed R312’s
insulin regimen; he discontinued the Novolin, and increased the amount of
Levemir from 30 units once a day, to 40 units twice a day and his Novolog
sliding scale remained the same. CMS Ex. 18 Part D at 30, 31, 32, 33, 34, 39.

On June 2, 2015, staff discontinued the 30 units of Novolin at 9 AM, the 20 units
of Novolin at 9 PM, and the 30 units of Levemir. However, Petitioner failed to
initiate the 40 units of Levemir twice a day at 9 AM and 9 PM. CMS Ex. 17 at
5-8, 21-23; CMS Ex. 18 Part D at 30; CMS Ex. 41 at 37; see also P. Ex. 38 at 4.

Petitioner’s staff only administered Novolog at 6:30 AM and 4:30 PM, until June
7, 2015. CMS Ex. 18 Part D at 30; see also P. Ex. 38 at 4.

On June 3, 2015, staff documented R312’s blood sugar as 389. Doctor’s orders
required administration of five units of insulin with that blood sugar level;
however, staff administered seven units of insulin. CMS Ex. 17 at 5-8, 21-23;
CMS Ex. 18 Part D at 30; CMS Ex. 41 at 37; Tr. 11/9 at 359.

Resident 307 (R307) is male and was born on July 24, 1947. CMS Ex. 18 Part I
at 36; P. Ex. 20 at 1.

Petitioner admitted R307 to its facility on November 20, 2012, with an admitting
diagnosis that included multiple joint contractures. P. Ex. 20 at 1.

Commencing September 17, 2014, Petitioner’s staff applied splints to R307’s
left hand and left elbow. CMS Ex. 18 Part J at 5; CMS Ex. 41 at 48.

On April 17, 2015, R307’s physician ordered that he wear two splints, one on his
left hand and another for his left elbow, from 10:00 AM until 4:00 PM as
tolerated, as needed, due to the contractures. CMS Ex. 18 Part J at 7.
13.

14.

15.

20.

On June 9, 2015, at 2:10 PM, Surveyor Garrett observed that R307 was not
wearing a hand splint. Additionally, although R307 was wearing an elbow
splint, it was not secure and, when R307 lifted his arm, the elbow splint hung
below R307’s arm. CMS Ex. 41 at 37-38 (Garrett Decl.); CMS Ex. 17 at 8-11;
CMS Ex. 18 Part I at 33, 60; Tr. 11/9 at 367-369, 371-372, 376.

On June 10, 2015, at noon, Surveyor Wilburn observed R307 wearing the hand
splint, but noted that the elbow splint was located on R307’s arm midway
between his shoulder and elbow. CMS Ex. 41 at 48-49; CMS Ex. 18 Part I at 33
(drawing of elbow splint placement); CMS Ex. 41 at 37-38; CMS Ex. 17 at 10-
11; Tr. 11/10 227-28.

At 2:30 PM on June 10, Surveyors Garrett and Wilburn observed R307 with the
splints essentially unchanged from the noon observation. CMS Ex. 41 at 37-38,
48-49; CMS Ex. 17 at 10; Tr. 11/9 at 371-72, 374-76.

On June 11, 2015, at 10:00 AM, Surveyor Wilburn observed R307 wearing his
hand splint, but his elbow splint was loose and again placed mid-arm rather than
over the elbow joint. CMS Ex. 17 at 10-11; CMS Ex. 41 at 48-49.

Licensed Practical Nurse (LPN) A admitted to Surveyor Wilburn that on June
10, 2015, the Certified Nursing Assistant (CNA) failed to correctly apply R307’s
splints. CMS Ex. 17 at 11; CMS Ex. 41 at 49; see CMS Ex. 20 Part B at 13.

CNA A, who applied the splints, explained to Surveyor Wilburn that the
hand/wrist splint was too long to fit properly at the same time as the elbow
splint. CMS Ex. 17 at 11; CMS Ex. 20 Part B at 13; CMS Ex. 41 at 49; Tr.
11/10 at 218.

Petitioner’s staff did not care plan for R307’s splints. The only care plan that
referenced R307’s splints was his wound care plan showing left hand and elbow
splints were implemented on September 17, 2014. However, that care plan did
not contain application times, instructions on how to apply the splints,
instructions to clean, alternatives to the splints, or adjunct services such as
restorative nursing, massage, or how to prevent skin issues from wear. CMS Ex.
17 at 11; CMS Ex. 18 Part J at 5; CMS Ex. 41 at 49.

On June 11, 2015, Petitioner referred R307 for an occupational therapy
evaluation. An Occupational Therapist (OT) stated that R307’s splints were an
“incorrect fit” and discontinued them. P. Ex. 20 at 5, 11. The OT prescribed
two alternative models instead. P. Ex. 20 at 5, 8, 17.
21.

22.

10

On June 17, 2015, R307’s clinician established a new timeline for R307 to wear
the newly ordered splints as follows: splints on at midnight, off at 6 AM; splints
on at 8 AM, off at 2 PM; splints on at 4 PM, off at 10 PM. P. Ex. 20 at 8.

On June 19, 2015, and again on June 22, 2015, the OT provided in-service
training on the splints - specifically, how to apply the splints, techniques to
facilitate proper resident positioning prior to application of the splint, skin
integrity checks, laundering and schedules. P. Ex. 20 at 17-18.

July 9, 2015 survey:

23.

24.

25.

26.

27.

28.

29.

Resident 416 (R416) is a female born on January 24, 1965. P. Ex. 29 at 1.

Petitioner admitted R416 to the facility on November 10, 2014, principally due
to chronic airway obstruction; however, she also had numerous other diagnosed
maladies. P. Ex. 29 at 1-2.

On June 12, 2015, R416’s doctor prescribed for her Percocet (i.e., Oxycodone
with acetaminophen 5 mg/ 325 mg tablet) by mouth every 4 hours as needed.
CMS Ex. 22 Part A at 40; P. Ex. 29 at 17; see also CMS Ex. 21 at 14.

At approximately 2:15 PM on July 8, 2015, Surveyor Polakoski observed R416
request pain medication from LPN Pollard. LPN Pollard opened his medication
cart and gave R416 a Percocet tablet. R416 swallowed the Percocet and
immediately left the vicinity. Surveyor Polakoski observed LPN Pollard remain
at the nurses’ station until 3:00 PM and R416 did not return during this period.
CMS Ex. 21 at 14; CMS Ex. 41 at 63; Tr. 11/9 at 301-02, 328-29.

Petitioner’s policy and procedure for pain assessment requires nursing staff to
assess the resident and complete the pain flow record/sheet when a resident
identifies that he has pain. Petitioner’s policy and procedure requires nursing
staff to document the following information in the pain flow record/sheet: date
and time, site/location, type of pain, intensity, precipitating/ aggravating,
interventions — non-med/ medication, intensity of pain after intervention, side
effects, and the nurse’s initials. P. Ex. 29 at 30.

Petitioner’s policy and procedure for oral medication administration requires the
nurse to “Chart on nurse’s notes: Pertinent observations immediately after
administration.” CMS Ex. 22 Part A at 9.

Surveyor Polakoski reviewed and photocopied the “Pain Flow Sheet” for R416
at 3:00 PM on July 8, 2015. CMS Ex. 41 at 63.
30.

31.

32.

33.

34.

35.

36.

37.

38.

11

The pain flow sheet Surveyor Polakoski photocopied on July 8, 2015, contained
only seven entries for medication provided between July 2 and July 6, 2015 and
nothing thereafter. CMS Ex. 22 Part A at 33.

On July 9, the facility’s Director of Nursing and its Regional Director of Clinical
Services provided Surveyor Polakoski with a pain flow sheet for R416, but now

it contained new entries for July 8, 2015: at 10:30 AM, 2:30 PM, and 6:30 PM.
CMS Ex. 22 Part A at 43; CMS Ex. 21 at 14-15; CMS Ex. 41 at 63.

The narcotics inventory sheets used to document and track narcotics
administration of Percocet to R416 indicated that staff administered Percocet ten
times between July 6, 2015 at 10:00 AM and July 8, 2015 at 2:30 PM. CMS Ex.
22 Part A at 44, 45.

The narcotics inventory sheets are the most accurate record of Petitioner’s
Percocet administration to R416. Cf. P. Ex. 33 at 10.

Between July 1, 2015, at 6:00 AM and July 8, 2015, at 3:00 PM, the narcotics
inventory sheets showed that Petitioner administered Percocet 32 times to R416.
CMS Ex. 22 Part A at 44-45. However, Petitioner’s modified pain flow sheet
only reflected that Petitioner administered Percocet to R416 ten times during that
period. CMS Ex. 22 Part A at 43. Petitioner did not assess R416 for pain,
attempt interventions, assess for effectiveness, and document all on the pain flow
sheet as required by its policy 23 out of 32 times during an 8-day period.

“{S]pecial risk patients” for Percocet are individuals with severe respiratory
impairment, severe renal impairment, or hypothyroidism. CMS Ex. 39 Part A at
44-45. R416 had chronic obstructive pulmonary disease, chronic kidney disease,
and hypothyroidism. P. Ex. 29 at 1-2.

Resident 405 (R405) is a male born on May 22, 1957. P. Ex. 25 at 1.

Petitioner admitted R405 to the facility on April 15, 2014, and then readmitted
him after a hospitalization on February 19, 2015. His diagnoses included
Down’s syndrome, quadriplegia, acute respiratory failure, arthropathy, anxiety,
hypertension, hypotension, convulsions, sleep apnea, dementia, and senile
dementia with depressive features. He had a tracheotomy and a percutaneous
endoscopic gastrostomy (PEG) tube. P. Ex. 25 at 1-2, 70-71.

R405’s most recent MDS with an assessment reference date of June 12, 2015,
indicated that he was not capable of making himself understood or of

understanding others. He was not able to speak. Although he could make eye
contact, he was not able to follow commands. He expressed anxiety and pain
39.

40.

41.

42.

43.

44.

45.

46.

47.

12

through facial expressions, restlessness, and involuntary movements. He
received all of his nutrition and medication through a PEG tube and received
nothing by mouth. P. Ex. 25 at 70-71, 78-79; Tr. 11/18 at 175, 177-178.

As early as February 19, 2015, R405’s physician ordered that he receive nothing
by mouth - including medication. CMS Ex. 22 Part F at 6, 9; P. 25 at 71.

On April 9, 2015, R405’s doctor drafted a clarification order to administer one
tablet “Prednisone 40 mg PO [(by mouth)] daily” for five days. P. Ex. 25 at 10.
However, later that day the order was clarified to “via Peg.” P. Ex. 25 at 11.

On April 15, 205, R405’s nurse practitioner ordered Glycopyrrolate three times a
day “PO.” P. Ex. 25 at 14.

R405’s May and July physician’s order sheets reiterate the error that R405 is to
receive Glycopyrrolate “by mouth.” CMS Ex. 22 Part F at 6, 9.

On June 17, 2015, R405’s doctor ordered 0.5 mg Clonazepam to be administered
“by mouth” at bedtime for seizures. CMS Ex. 22 Part F at 6, 9.

R405’s July physician’s order sheet reiterates the error that R405 is to receive
Clonazepam “by mouth.” CMS Ex. 22 Part F at 6, 9.

In May, June and July, 2015, Petitioner’s nursing staff initialed that they
provided R405 with Glycopyrrolate “by mouth,” and in July, Clonazepam “by
mouth.” P. Ex. 25 at 44, 50, 58. Petitioner’s staff did not actually follow the
doctor’s orders and provided the medication to R405’s via his PEG tube.

Petitioner did not obtain a modified physician order for the medications to be
administered by PEG tube until after the surveyors brought the error to
Petitioner’s staff's attention. Tr. 11/10 at 139-40; P. Ex. 25 at 92.

Had Petitioner’s staff followed the doctor’s order to administer the medication
by mouth, R405 could have aspirated, resulting in harm. CMS Ex. 43 at 23.

IV. Conclusions of Law and Analysis’

My conclusions of law are in italics and bold.

7 Thave not discussed every deficiency appearing in the June and July Statements of
Deficiencies because the deficiencies I uphold below are more than sufficient to justify
the remedies CMS imposed. See Claiborne-Hughes Health Ctr., 609 F.3d 839, 847 (6th
Cir. 2010); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010).
13

I. The deficiencies cited at Petitioner’s facility in the surveys that concluded on
January 8, 2015, March 2, 2015, and April 30, 2015, are administratively
final because Petitioner did not contest them.

As previously noted, Petitioner does not contest the deficiencies cited in the surveys
concluding January 8, 2015, March 2, 2015, and April 30, 2015, and, therefore, the
deficiencies and related remedies are administratively final. Accordingly, it is not at
issue in this case that Petitioner was not in substantial compliance beginning on January
8, 2015, through the April 30, 2015 survey.

2. Petitioner failed to demonstrate that it returned to substantial compliance by
June 2, 2015.

Petitioner argues that, while it does not challenge the deficiencies identified in the April
30, 2015 survey, it corrected all of the deficiencies identified in that survey by June 2,
2015, several days before the revisit survey that concluded on June 11, 2015.

In asserting its return to substantial compliance by June 2, 2015, Petitioner relies on the
following: the state agency approved Petitioner’s plan of correction (P. Ex. 7) in which
Petitioner asserted it would correct all deficiencies by June 2, 2015; the state agency
concluded at the end of the June 11, 2015 revisit survey that Petitioner corrected a
number of the deficiencies identified in the April 30, 2015 survey by June 2, 2015 (P.
Ex. 8); CMS did not specifically find that all of the deficiencies from the April 30, 2015
survey were not corrected; and Petitioner submitted evidence in this proceeding of its
return to compliance by June 2, 2015. P. Post Hrg. Br. at 6-8.

I conclude that Petitioner’s arguments are not availing. “Under the regulations, the mere
submission of a [plan of correction] d[oes] not establish that any cited deficiencies had
been corrected.” Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002).
Although CMS had the option of accepting that Petitioner corrected all deficiencies under
a plan of correction without conducting an additional survey, CMS did not do this here.
42 C.F.R. §§ 488.454(a)(1), 488.401.

The April 30, 2015 survey identified the following deficiencies at the D level of scope
and severity or higher: 42 C.F.R. § 483.10(n) (F176); 42 C.F.R. § 483.15(h)(1) (F252);
42 C.F.R. §§ 483.20(d)(3), 483.10(k)(2) (F280); 42 C.F.R. § 483.20(k)(3)(i) (F281);

42 CFR. § 483.25 (F309); 42 C.F.R. § 483.25(a)(3) (F312); 42 C.F.R. § 483.25(c)
(F314); 42 C.F.R. § 483.25(g)(2) (F322); 42 C.F.R. § 483.25(h) (F323); 42 C.F.R.

§ 483.25(k) (F328); 42 C.F.R. § 483.25(m)(2) (F333); and 42 C.F.R. § 483.65 (F441).
CMS Ex. 13 Parts A, B. During the June 11, 2015 revisit survey, the state agency
determined that Petitioner corrected the following deficiencies as of June 2, 2015:

42 C.F.R. § 483.10(n) (F176); 42 C.F.R. § 483.15(h)(1) (F252); 42 C.F.R.

§§ 483.20(d)(3), 483.10(k)(2) (F280); 42 C.F.R. § 483.20(k)(3)(i) (F281); 42 C.F.R.
14

§ 483.25(a)(3) (F312); 42 C.F.R. § 483.25(c) (F314); and 42 C.F.R. § 483.25(h) (F323).
CMS Ex. 33 at 3. However, the state agency determined that five deficiencies from the
April 30, 2015 survey remained uncorrected: 42 C.F.R. § 483.25 (F309); 42 C.F.R.

§ 483.25(g)(2) (F322); 42 C.F.R. § 483.25(k) (F328); 42 C.F.R. § 483.25(m)(2) (F333);
and 42 C.F.R. § 483.65 (F441). CMS Ex. 17 at 1, 5-8, 12-27. Further, CMS expressly
adopted the state agency’s findings that Petitioner did not correct those five deficiencies.
P. Ex. 4 at 2. Therefore, it is clear that CMS concluded that Petitioner had not corrected
all of the deficiencies from the April 30, 2015 survey by June 2, 2015.

Petitioner also asserts that it submitted evidence (P. Exs. 9-16), including written
testimony (P. Ex. 33 at 2; P. Ex. 34 at 1-6), of the action that it took to correct the
deficiencies from the April 30 survey by June 2, 2015. P. Post Hrg. Br. at 7-8. However,
a review of Petitioner’s evidence reveals that it fails to demonstrate that Petitioner
returned to substantial compliance by June 2, 2015. Almost all of the evidence, including
the witness testimony, is directed at the efforts made to correct the deficiencies for which
the state agency found that Petitioner had returned to substantial compliance by June 2,
2015 (i.e., the corrected deficiencies listed in CMS Ex. 33 at 3). “[OJnce a facility has
been found to be out of substantial compliance, it remains so until it affirmatively
demonstrates that it has achieved substantial compliance once again.” Premier Living &
Rehab Ctr., DAB No. 2146, at 23 (2008). This, Petitioner plainly failed to do.

Therefore, I conclude Petitioner did not return to substantial compliance by June 2, 2015.

3. Petitioner was not in substantial compliance with Medicare program
participation requirements based on the survey concluding on June 11, 2015.

a. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25
(F309) and subsection (m)(2) (F333) because Envoy did not provide
R312 the necessary care and services to manage his diabetes when its
staff failed to administer the proper long-acting diabetes medication
for more than four days and, at the same time, failed to administer the
correct dose of the short-acting diabetes medication, constituting a
significant medication error.*

Petitioner admitted R312, a 50-year-old man, on June 3, 2014 for treatment of
uncontrolled diabetes, cerebrovascular disease with hemiplegia of his left side, an aortic
valve replacement, peripheral vascular disease, hypertension, depression, and pressure
ulcers, among other issues. He had osteomyelitis with gangrene of his left foot, which
required amputation at some point after admission. P. Ex. 18 at 1-3; P. Post-Hrg. Br. at
12; CMS Ex. 18 Part D at 33-34.

* Both F309 and F333 were repeated violations from the April 30, 2015 survey. CMS
Ex. 13 Part A at 40-49; CMS Ex. 13 Part B at 19-30. The F333 deficiency from that
survey also involved a failure to administer diabetic medication. CMS Ex. 20 Part A at 1.
15

By November 2014, R312 had an extensive regimen to treat his diabetes. He was
receiving rapid-acting insulin (Novolog), intermediate-acting insulin (Novolin N), and
long-acting insulin (Levemir). Specifically, his physician ordered:

e Novolog at 6:30 AM (rapid-acting) every morning, based on a sliding scale,
e 30 units of Levemir (long-acting) at 9 AM every morning,

e 30 units of Novolin (intermediate-acting) at 9 AM every morning,

e Novolog at 4:30 PM every evening based on a sliding scale, and

e 20 units of Novolin at 9 PM every evening.

CMS Ex. 18 Part D at 30-31, 41-42; P. Ex. 18 at 5. On June 2, 2015, Dr. Thompson
determined that Petitioner’s diabetes was “poorly controlled” and changed R312’s
regimen; he discontinued the Novolin, and increased the amount of Levemir from 30
units once a day, to 40 units twice a day and his Novolog sliding scale remained the
same. CMS Ex. 18 Part D at 30, 31, 32, 33, 34, 39. During the revisit survey that ended
on June 11, 2015, the surveyors found the following, as described in the Statement of
Deficiencies under violations of both 42 C.F.R. § 483.25 (F309) (“Provide Care/Services
for Highest Well Being”) and 42 C.F.R. § 483.25(m)(2) (F333) (“Resident Free of
Significant Med Errors”):

Resident #312’s clinical record was reviewed. Included was
a physician progress note dated 6/2/15. The “Assessment and
Plans” section read “1) DM2 (diabetes mellitus)-ongoing-
poorly controlled.” “Levemir 40 u (units) q12h (every 12
hours”. A telephone order dated 6/2/15 read “D/C
(discontinue) current Levemir” “start Levemir 40 u (units)
q12h (every 12 hours”).

A telephone order dated 6/2/15 read “D/C (discontinue)
current Levemir” “start Levemir 40 u (units) q12h (every 12
hours)”.

The June 2015 Medication Administration Record (MAR)
was reviewed. The current order for Levemir (30 units) was
discontinued on 6/2/15. The new order for Levemir (40 units)
was not started until 6/7/15. Resident #312 did not receive
Levemir for 4 days.

Resident #312 had a physician order dated 7/4/14 for
Novolog sliding scale insulin. The sliding scale read,
“Sliding scale blood sugar at 6:30 a.m. & 4:30 p.m. 200-299
give 3 units subq (subcutaneous): 300-399 give 5 units subq:
400 units or above give 7 units subq: And call MD”.
16

On 6/3/15, 4:30 p.m., Resident #312’s blood sugar was
documented as 389 on the June 2015 MAR. It was
documented that 7 units of insulin was administered at this
time. According to the sliding scale order, Resident #312
should have received 5 units of insulin. Resident #312
received 2 extra units of insulin.

On 6/10/15 at 2:30 p.m., the issue with the wrong amount of
sliding scale insulin was reviewed with 3rd Floor Assistant
Director of Clinical Services (RN A). She agreed that the
wrong amount was administered stating “I see what you
mean.”

CMS Ex. 17 at 6-7, 22-23.

In response to this, Petitioner stated that “CMS’ factual allegations basically are true” and
that “it is true that a nurse confused her transcription of [Dr. Thompson’s June 2, 2015]
order in a way that the Resident was not administered any Levemir for all four days (at
which point a Center audit found and corrected the error).” P. Post-Hrg. Br. at 12-13.
Petitioner does challenge the conclusion that its actions are substantial noncompliance.

Petitioner argues that its failure to give eight consecutive doses of long acting insulin
(Levemir) and its administration of the incorrect dose of short acting insulin (Novolog)
did not result in the potential for more than minimal harm. P. Post-Hrg. Br. at 12.
Petitioner asserts that its staff continued to make routine blood sugar checks on R312 and
that during the time Petitioner did not administer the Levemir, R312’s blood sugar levels
remained in the same general range of the preceding weeks. P. Post-Hrg Br. at 13. For
this argument, Petitioner relies primarily on the testimony of Dr. Thompson, Petitioner’s
medical director and the physician who ordered the June 2, 2015 changes. P. Ex. 38 at 4.
Dr. Thompson testified that the facility’s errors did not result in the potential for more
than minimal harm to R312 because facility staff was closely monitoring his blood sugar,
staff was still administering short-term insulin, and his blood sugar never rose to the point
that necessitated informing the doctor. P. Ex. 18 at 28-29; P. Ex. 38 at 4; Tr. 11/10 at
314, 318, 320. Dr. Thompson also thought it insignificant that Petitioner administered
too much Novolog to R312. P. Ex. 38 at 5.

The quality of care regulation requires that the facility provide the necessary care or
services to attain or maintain “the highest practicable physical, mental, and psychosocial
well-being, in accordance with the comprehensive assessment and plan of care.”

42 CFR. § 483.25; see also Act § 1819(b)(2), 42 U.S.C. § 1395i-3. The “quality-of-
care” regulation also requires that the facility “ensure” that its “r[e]sidents are free of any
significant medication errors.” 42 C.F.R. § 483.25(m)(2).
17

A “medication error may be significant if it ‘jeopardizes’ - that is, has the potential to
harm - the resident’s health.” Life Care Ctr. of Tullahoma, DAB No. 2304, at 44 (2010)
(emphasis in the original). No showing of actual harm to a resident is necessary to
conclude that an error is significant. Id.; Northern Montana Care Ctr., DAB No. 1930
(2004); Rosewood Care Ctr. of Peoria, DAB No. 1912 (2004).

CMS’s State Operations Manual (SOM) provides the following framework for
considering potential violations of 483.25(m)(2):

Resident Condition - The resident’s condition is an important
factor to take into consideration. For example, a fluid pill
erroneously administered to a dehydrated patient may have
serious consequences, but if administered to a resident with a
normal fluid balance may not. If the resident’s condition
requires rigid control, a single missed or wrong dose can be
ighly significant.

Drug Category - If the medication is from a category that
usually requires the patient to be titrated to a specific blood
level, a single medication error could alter that level and
precipitate a reoccurrence of symptoms or toxicity. This is
especially important with a medication that has a Narrow
Therapeutic Index (NTI) (i.e., a medication in which the
therapeutic dose is very close to the toxic dose) ....

Frequency of Error - If an error is occurring with any
frequency, there is more reason to classify the error as
significant. For example, if a resident’s medication was
omitted several times . . ., classifying that error as significant
would be in order. This conclusion should be considered in
concert with the resident’s condition and the drug category.

SOM, App. PP (tag 333).

Based on applying the law to the facts in this case, I conclude that Petitioner was not in
substantial compliance with 42 C.F.R. §§ 483.25 (F309) and 483.25(m)(2) (F333). As
indicated above, on June 2, 2015, Petitioner’s staff discontinued the administration of 30
units of Levemir, 30 units of Novolin at 9 AM and 20 units of Novolin at 9 PM to R312,
and failed to implement the order for 40 units of Levemir at 9 AM and 40 units of
Levemir at 9 PM until June 7, 2015. As such, Petitioner did not provide R312 with either
a morning or an evening dose of the increased dosage and frequency of the long-acting
18

insulin. Therefore, R312 was only receiving the short acting insulin twice a day:

e Novolog at 6:30 AM every morning based on a sliding scale, and
¢ Novolog at 4:30 PM every evening based on a sliding scale.

CMS Ex. 18 Part D at 30. Further, the evidence shows that during the period when
facility staff failed to treat R312’s diabetes properly, they also failed to administer the
correct dose of Novolog. See Tr. 11/9 at 359. On June 3, 2015, staff documented R312’s
blood sugar as 389. According to the doctor’s order, staff was to administer five units of
insulin. However, facility staff administered seven units of insulin. CMS Ex. 17 at 5-8,
21-23; CMS Ex. 18 Part D at 30; CMS Ex. 41 at 37.

CMS’s expert witness, Dr. Lesesne, provided specific testimony as to each of the SOM’s
three factors quoted above. Dr. Lesesne stated that R312’s condition involved poorly
controlled type 2 diabetes, which had already led to “serious complications due to the
iagnosis (coronary artery disease, peripheral vascular disease, left foot osteomyelitis)
which reflected the severity of his diabetes ... . As a result, it was extremely important
that Envoy nursing staff implement physician orders correctly regarding the management
of Resident 312’s diabetes.” CMS Ex. 41 at 6. As to the drug category involved, Dr.
Lesesne testified that both Levemir and Novolog are indicated for glycemic control and
that “the failure to administer these medications or the administration of the incorrect
losage may result in the failure to control the individual’s blood glucose levels.” CMS
Ex. 41 at 6. Finally, Dr. Lesesne testified that the frequency of the error of four straight
jays involving two medications (Levemir and Novolog), which were meant to act in
concert with each other, “increased the resident’s risk of out of control blood sugar levels
because it was not an isolated error.” CMS Ex. 41 at 6.

In regard to R312’s blood sugar level, Dr. Lesesne explained that monitoring a resident
oes not alleviate the risk of harm that can result from the failure to administer a long-
acting medication because it does nothing to prevent, manage, or control “wide swings”
in blood sugar levels. Tr. 11/18 at 364-365. Dr. Lesesne explained that monitoring a
resident would only alert the staff of these “wide swings” after they have already
occurred. Jd. at 365. Indeed, providing some treatment to R312 is better than providing
no treatment. However, as Dr. Lesesne explained: “[I]t’s like having a car going down
the road. There are guardrails to keep you out of a critical care situation, but it’s not
anywhere close to control.” Jd. at 366. Non-critical, but out of control blood sugar can
lead to severe consequences. Dr. Thompson conceded that an “extremely elevated blood
sugar level can cause in a patient lethargy and nausea, especially if the patient is not
accustomed to elevated blood sugar levels.” Tr. 11/10 at 322. However, in the context of
R312’s condition, Petitioner’s failure to administer the proper medication could have led
to hyperglycemia or hypoglycemia. Hyperglycemia, or elevated blood glucose levels,
can cause dehydration, low blood pressure, altered mental status and could exacerbate
R312’s complications from diabetes, including coronary artery disease and peripheral

19

vascular disease. CMS Ex. 41 at 6. Hypoglycemia, or low blood glucose levels, could
cause confusion, weakness, flushing/sweating, coma, and even death. CMS Ex. 41 at 6.
l accept Dr. Lesesne’s opinion and conclude that Petitioner’s medication errors regarding
R312 posed a potential for more than minimal harm to R312. Dr. Thompson’s
conclusion that Petitioner’s failure to administer both the long and short acting
medications did not cause the potential for minimal harm is not persuasive, especially
since Dr. Thompson thought R312’s condition required his intervention on June 2, 2015,
to change the administration of the Levemir and Novolog. Dr. Lesesne explained that Dr.
Thompson ordered both the short acting and the long acting medications to act in concert
to improve R312’s glycemic control. He notes that errors implementing both
medications reduced the medication’s effectiveness in controlling R312’s diabetes. CMS
Ex. 41 at 6. In the context of R312’s condition, Dr. Thompson himself termed R312’s
diabetes as “poorly controlled.” CMS Ex. 18 Part D at 34. I do not believe that Dr.
Thompson would note R312’s “poorly controlled” diabetes and change R312’s insulin
medication by increasing the long-acting medication substantially if it were not
necessary. | find it unlikely that a failure to provide 40 units of Levemir twice daily
would be negligible to a diabetic, let alone to R312. Therefore, I conclude that Petitioner
was not in substantial compliance with 42 C.F.R. §§ 483.25, 483.25(m).

b. Petitioner was not in substantial compliance with 42 C.F.R.
§ 483.25(e)(2) (F318) when it failed to provide properly fitting splints
to R307 to increase his range of motion or prevent further decrease in
range of motion, but instead left him with ill-fitting splints, and
painful and exacerbated contractures.

R307 was born on July 24, 1947, and was admitted to Petitioner’s facility on November
20, 2012. P. Ex. 20 at 1. R307 was at Petitioner’s facility for treatment of his medical
conditions including Parkinson’s disease, cerebrovascular accident, joint contractures,
paralysis agitans, seizure disorder, depression, and dementia. P. Ex. 20 at 1-2, 11; CMS
Ex. 18 Part I at 43.

A joint contracture is a serious condition. With a joint contracture, there “is a decrease in
angle in the joint. As the joint becomes contracted, the extremity or the body part will
move toward the midline and become frozen.” Tr. 11/10 at 211. Apparently in an effort
to combat this problem, on September 17, 2014, Petitioner’s staff commenced providing
R307 with braces for his left arm and left elbow. CMS Ex. 18 Part J at 5. However,
there was no other documentation about the splints from 2014. Tr. 11/10 at 211-12.
Further, when the surveyors reviewed R307’s care plan, it only mentioned splints with
regard to his wound care plan and the wound care plan only referenced that there were
“splints to left hand and left elbow,” but added no further information such as application
times when they were to apply them or even how to assure proper fitting to prevent
contractures and any related skin issues. CMS Ex. 18 Part J at 5; CMS Ex. 17 at 11.
Although there was an evaluation on April 14, 2015, the documentation of this evaluation
20

contained nothing about the elbow splint and only barely referenced R307’s hand splint.
However, on April 17, 2015, a physician ordered that splints for R307’s left hand and left
elbow be worn from 10:00 AM until 4:00 PM as tolerated and as needed. CMS Ex. 18
Part J at 5, 7; P. Ex. 20 at 3.

Upon request of Surveyor Wilburn, Petitioner’s administrator and DON provided the
manufacturer’s instructions for the wrist splint, but did not provide instructions for the
elbow splint. CMS Ex. 41 at 48. The hand splint manufacturer’s instructions stated the
splint was to treat contractures in the fingers, hand, and wrist, through progressive static
positioning. The device featured supportive positioning to prevent contractures of flaccid
ands and wrists. CMS Ex. 18 Part I at 35. The hand splint was physically extensive; it
encased R307’s entire forearm, extending from under his fingers to his antecubital space.
CMS Ex. 17 at 9; Tr. 11/9 at 375-376.

Both Surveyors Garrett and Wilburn testified that throughout the survey, they observed
R307 either not wearing both splints or wearing improperly applied splints. CMS Ex. 41
at 37-38 (Garrett Decl.), 47-50 (Wilburn Decl.); CMS Ex. 17 at 8-11; Tr. 11/9 at 367-
369, 371-372, 374-76; Tr. 11/10 227-28. On June 9 at 2:10 PM, Surveyor Garrett, a
Registered Dietitian, observed R307 without a hand splint. /d.; CMS Ex. 18 Part I at 60.
R307 was wearing an elbow splint but Surveyor Garrett described it as so loose that it
could essentially spin around his arm; she could fit the width of a hand between the splint
and the resident’s arm and there would still be room for the splint to rotate around his
arm freely. Jd.; CMS Ex. 18 Part I at 33.

On June 10, 2015, both Surveyors Garrett and Wilburn observed R307 wearing the hand
splint appropriately, but the elbow splint loose and unsupportive. At noon, Surveyor
Wilburn observed R307 wearing the hand splint, but described the elbow splint similarly
loose as Surveyor Garrett described the previous day. Namely, Surveyor Wilburn
testified that staff applied the Velcro straps “so loose that it could easily be moved in a
full circle around the resident’s arm and there was a space between the resident’s arm and
the splint that was so large the width of a hand could fit in the space.” CMS Ex. 41 at 49.
She explained that staff applied the splint so loose that it did not even stabilize R307’s
elbow. In addition, staff applied the elbow splint not to R307’s elbow, but midway
between R307’s shoulder and elbow joints, rendering the splint useless. Id.; CMS Ex. 18
Part I at 33 (surveyor’s drawing of elbow splint placement); CMS Ex. 41 at 37-38; CMS
Ex. 17 at 10-11. Later that day at 2:30 PM, both surveyors Garrett and Wilburn observed
R307 with the splints essentially unchanged from Surveyor Wilburn’s observation at
noon. CMS Ex. 41 at 37-38, 48-49; CMS Ex. 17 at 10; Tr. 11/9 at 371-372.

On June 10, Surveyor Wilburn interviewed facility staff about the observed problems
with the splints. When she asked LPN A about the issue, LPN A responded: “They are
not on right, the CNA’s put them on.” Surveyor Wilburn next interviewed CNA A, who
applied the splints. CNA A explained, “the wrist splint is so long that the elbow splint
21

doesn’t fit right over it.” CMS Ex. 17 at 11; CMS Ex. 20 Part B at 13; CMS Ex. 41 at 49;
Tr. 11/10 at 218. Both the LPN and CNA conceded that they had not notified the therapy
department to address the problem. /d. Significantly, Petitioner did not submit written
testimony from either LPN A or CNA A to dispute the surveyors documented statements
of these two individuals.

On June 11, Surveyor Wilburn observed a fourth incidence where Envoy’s staff failed to
apply R307’s splints properly. She testified that the splint was in the same position as the
prior to observations. CMS Ex. 17 at 10-11; CMS Ex. 41 at 48-49. These observations
form the factual basis for a deficiency under 42 C.F.R. § 483.25(e)(2) (F318) of the
quality of care regulation that requires that an SNF ensure that a “resident with a limited
range of motion receives appropriate treatment and services to increase range of motion
and/or to prevent further decrease in range of motion.” 42 C.F.R. § 483.25(e)(2).

Petitioner primarily argues in opposition to this deficiency that the observation of
Surveyor Garrett is unreliable because she is not a nurse. P. Post-Hrg Br. at 16-17.
However, Surveyor Garrett was the sole witness to only one of the four occurrences of
problems noted with R309’s splints. In any event, although she may not be an expert in
splint fitting, she can observe whether a resident is wearing a splint on his hand, which he
was not. Further, she can observe if an elbow splint is so loose that it is obviously
incorrect, even to an untrained eye. Importantly, Surveyor Wilburn, a registered nurse
with extensive experience, several times observed similar problems with R307’s splints
and, thus, validated Surveyor Garrett’s concerns.

Petitioner also asserts that its staff correctly applied the splints, but that R307 was
responsible for removing his splints, whether intentionally or just by moving his arm,

and that there was not a violation because the physician’s order was for R307 to wear the
splints “as tolerated” or “as needed.” P. Post-Hrg. Br. at 16-17; P. Reply at 8-9.
Petitioner’s witnesses, Ms. Springer and Ms. Hirn testified that R307 asked for the splints
to be removed because they were uncomfortable or removed them himself. P. Ex 37 at 1;
Tr. 11/18 at 240.

Although Ms. Springer and Ms. Hirn testified that Petitioner’s lack of compliance with a
physician’s order to wear the splints would be documented (Tr. 11/10 at 264; Tr. 11/18 at
239-40), Petitioner provides no such documentation to support its contention that
Petitioner regularly asked to have the splints removed or that he removed them himself.
Further, it is questionable that R307 had the fine motor control to remove the splints
imself. Tr. 11/10 at 241.

Petitioner’s staff admitted and the surveyors’ observations showed that not only did the
staff apply the elbow splint improperly, but that it was not even possible to apply it
properly because both splints could not be applied at the same time. CMS Ex. 17 at 11;
CMS Ex. 20 Part B at 13; CMS Ex. 41 at 49; Tr. 11/10 at 218. This is consistent with the

22

June 11, 2015 OT evaluation of R307. The OT determined that R307 presented with
“progression of flexor tone abnormality [related to the] disease processes of Parkinson[’s
Disease] and Cerebral Vascular Disease causing inability to tolerate and incorrect fit of
[left upper extremity] orthotics.” P. Ex. 20 at 11 (emphasis added). The OT evaluated
R307’s range of motion. P. Ex. 20 at 17. The OT discontinued the prior elbow and wrist
splints and prescribed two alternative models. P. Ex. 20 at 5, 8. The OT ordered staff to
apply the new splints three times a day. Therefore, even if Petitioner sought to remove
his splints, he did so because they did not fit him. If the movement of his arms caused
the splints to loosen, then Petitioner’s staff should have addressed this immediately.

When the splints were not fitting together correctly, the staff should have sought the
expertise of a therapist who could properly assess R307. Instead, they simply applied the
elbow splint so loose that it fit more like a “bracelet.” Tr. 11/10 at 218. By not
addressing R307’s contractures, the facility caused the potential for more than minimal
harm. Surveyor Wilburn stated that in her expert option, the facility’s failure to apply
R307’s splints correctly deprived R307 of the “therapeutic benefit of
treatment/intervention for [R307’s] contractures which could result in a decrease in range
of motion and the further development and progress of the contractures. Additionally,
the facility’s failure to properly address [R307’s] hand and elbow contractures may result
in an increased risk of pressure ulcers due to chafing of skin on the fingers from hand
contractures and the chafing of skin on the elbow/arm to body.” CMS Ex. 41 at 50. In
fact, after reading the therapy evaluation, Surveyor Wilburn went a step further stating
that she would have increased the scope and severity of the citation. Tr. 11/10 at 216.

Unfortunately, Petitioner waited until the surveyors brought it to their attention to address
the issue. The chart reflects that R307’s condition had declined. Once the OT conducted
a thorough assessment, the therapist changed to different wrist and elbow splints,
different application cycles, and noted decreased range of motion. The therapist noted
that his impairments were exacerbated, the splints did not fit correctly, and R307
experienced pain in his extremity which also needed to be addressed with not only new
splints but training in pain management techniques. P. Ex. 20 at 11. The appropriate
treatment was an altogether different set of splints, and to treat his now deteriorated
condition through a significant increase in the length of time R307 was to wear them —
from six to eighteen hours a day. P. Ex. 20 at 8. Petitioner did not provide the needed
care and services to treat R307’s contractures and to prevent them from worsening. It is
clear that Petitioner was not providing appropriate treatment and services to increase
R307’s range of motion and/or to prevent further decrease in his range of motion.

As stated above, section 483.25(e)(2) (F318) of the quality of care regulation requires
that an SNF ensure that a “resident with a limited range of motion receives appropriate
treatment and services to increase range of motion and/or to prevent further decrease in
range of motion.” 42 C.F.R. § 483.25(e)(2). Based on the evidence before me, I
conclude that Petitioner was not in substantial compliance with that regulation.
23

4. Petitioner was not in substantial compliance with Medicare program
participation requirements based on the survey concluding on July 9, 2015.

a. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25
(F309) when staff administered pain medication to R416 without first
assessing for pain and attempting non-pharmacological interventions
in accordance with Petitioner’s policy, and when Petitioner failed to
monitor the effectiveness of pain medication administered to R416
and to maintain adequate records of the amount of pain medication
administered to R416.

As previously explained, the quality-of-care regulation requires the facility to provide the
necessary care and services to residents to attain or maintain the highest practicable
physical, mental, and psychosocial well-being, in accordance with the resident’s
comprehensive plan of care. Act § 1819(b)(2), 42 U.S.C. § 1395i-3; 42 C.F.R. § 483.25.
The intent is for the facility to ensure that each resident obtains optimal improvement or
does not deteriorate within the limits of a resident’s right to refuse treatment, and within
the limits of recognized pathology and the normal aging process.

The quality of care legislative and regulatory requirements are “based on the premise that
the facility has (or can contract for) the expertise to first assess what each resident’s
needs are (in order to attain or maintain the resident’s highest practicable functional
level) and then to plan for and provide care and services to meet the goal.” Spring
Meadows Health Care Ctr., DAB No. 1966, at 16 (2005). The regulation thus “imposes
on facilities an affirmative duty designed to achieve favorable outcomes to the highest
practicable degree.” Windsor Health Care Ctr., DAB No. 1902, at 16-17 (2003), aff'd,
Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005). The facility must take
“reasonable steps” and “practicable measures to achieve that regulatory end.” Clermont
Nursing & Convalescent Ctr., DAB No. 1923, at 21 (2004), aff'd, Clermont Nursing &
Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005).

A failure to follow a resident’s plan of care that is based on the comprehensive resident
assessment is a clear case of failing to meet the requirements of 42 C.F.R. § 483.25.
Cedar Lake Nursing Home, DAB No. 2288, at 6-7, 10 (2009), aff'd, Cedar Lake Nursing
Home vy. U.S. Dep’t of Health & Human Servs., 619 F.3d 453 (5th Cir. 2010); Spring
Meadows Health Care Ctr., DAB No. 1966, at 17 (2005). Further, the language of

42 C.F.R. § 483.25 not only requires skilled nursing facilities to furnish the care and
services set forth in a resident’s care plan, but also to implement doctors’ orders, monitor
and document the resident’s condition, and follow its own policies. See, e.g., Alexandria
Place, DAB No. 2245 (2009) (upholding this deficiency when a petitioner did not
provide care in accordance with a doctor’s order); Oxford Manor, DAB No. 2167, at 5-6
(2008) (affirming an ALJ’s reliance on a facility’s policy as evidence of the standard of
care the facility expected its staff to provide, noting “if facility staff exercise professional
24

judgment in deciding not to follow facility policy with respect to a particular resident,
they document that judgment and give a reason why not. In the absence of such
contemporaneous documentation, it is certainly reasonable to infer, when staff do not
follow the policy, either they are not aware of it or that they are simply disregarding it.”);
Spring Meadows Health Care Ctr., DAB No. 1966, at 17 (“[T]he clearest case of failure
to meet [section 483.25] is failure to provide one of the specific services outlined in the
subsections or failure otherwise to follow the plan of care based on the comprehensive
resident assessment. . .”).

Petitioner admitted R416, a 50-year-old female, to the facility on November 10, 2014. P.
Ex. 29 at 1-2. Her diagnoses included past stroke, chronic obstructive pulmonary
disease, history of falls, chronic pain, coronary artery disease, psychosis, chronic kidney
disease, depression, diabetes, anemia, and hypothyroidism. P. Ex. 29 at 1-2. She had no
cognitive impairment, but was completely dependent on facility staff for activities of
daily living. CMS Ex. 22 Part A at 5-50. R416’s doctor prescribed her:
“Oxycodone/APAP [acetaminophen] 5 mg/ 325 mg Tablet . . . Percocet 1 [tablet] by
mouth[,] every 4 hours as needed... .” CMS Ex. 21 at 14; see CMS Ex. 22 Part A at 40;
P. Ex. 29 at 17, 18.

Surveyor Polakoski testified that at 2:15 PM on July 8, 2015, he observed R416, who was
in her wheelchair, approach LPN Pollard and request “pain medication.” LPN Pollard
responded by opening his medication cart and giving R416 a Percocet tablet. R416
swallowed the Percocet and immediately left the vicinity by taking the elevator to a
different floor of the facility. Surveyor Polakoski observed LPN Pollard remain at the
nurses’ station until 3:00 PM. Surveyor Polakoski did not observe further interaction
between R416 and LPN Pollard and R416 did not return to the area during this period.
CMS Ex. 21 at 13-20; CMS Ex. 41 at 63; Tr. 11/9 at 301-02, 328-29.

Petitioner’s policy and procedure for pain assessment is contained in the record. That
policy instructs the nursing staff to complete the pain flow record when a resident has
identified they have pain. Petitioner instructs its staff to include the following
information in the pain flow record (P. Ex. 29 at 30):

date and time,

site/location,

type of pain,

intensity,

precipitating/ aggravating,
interventions — non-med/ medication,
intensity of pain after intervention,
side effects, and

the nurse’s initials.
25

However, Petitioner did not follow its policy and procedure when treating R416.

Surveyor Polakoski further testified that at 3:00 PM, he reviewed and copied the “Pain
Flow Sheet” for R416. CMS Ex. 41 at 63. The facility’s policy and procedure explains
that the purpose of the pain flow record is to document nursing’s assessment of a
resident’s pain, non-pharmaceutical interventions attempted, and the effectiveness of both
pharmaceutical and non-pharmaceutical interventions. P. Ex. 29 at 30. In addition, it is
to assure non-pharmaceutical interventions are utilized and as a reference for past
successful or unsuccessful interventions. Jd. However, R416’s pain flow sheet did not
contain any entries regarding pain assessment, non-pharmaceutical interventions, their
effectiveness, or the administration of the Percocet at 2:15 PM or its effectiveness. In
fact, the last entry was from July 6, 2015 at 10:00 AM. CMS Ex. 22 Part A at 33.

On July 9, 2015 at 9:30AM Surveyor Polakoski interviewed Petitioner’s Director of
Nursing, Sherri Stith, and the Regional Director of Clinical Services, Melinda Hirn.
They provided the surveyor with the pain flow sheet for R416; however, the document
now contained three entries on July 8, 2015, which documented pain levels and
interventions. CMS Ex. 22 Part A at 43. Surveyor Polakoski showed them the original
pain flow sheet he copied the previous day, which did not contain any entries on July 8,
2015. Compare CMS Ex. 22 Part A at 33 (as of July 8) with 43(as of July 9). The staff
had no comment. CMS Ex. 21 at 14-15; CMS Ex. 41 at 63.

Surveyor Polakoski conducted a review of the narcotics inventory sheets used to
document and track narcotics administration of Percocet for R416. CMS Ex. 22 Part A at
44, 45. These forms indicated that staff administered R416 Percocet nine times between
July 6, 2015 at 10:00 AM and July 8, 2015 at 2:30 PM. Jd. Yet, the pain flow sheet did
not reflect that the facility conducted pain assessments during that period. CMS Ex. 22
Part A at 33 (pain flow sheet obtained on July 8, 2015).

LPN Pollard, who administered the medication in front of the surveyor, completed a
witness statement on July 9, 2015. P. Ex. 29 at 25. LPN Pollard states that R416 came to
him at approximately 12:45 PM “complaining of pain in her neck and various other
places” and requested pain medication. /d. “But due to the medication being
administered at 10:30 AM it was too soon for her to receive it.” Jd. LPN Pollard
explains, “The order for medication is [every four hours]. [R416] left and came back to
the cart at [2:30 PM] and requested . . . the medication once again. And the medication
was administered at [that] time.” /d. Except to the extent that the alleged administration
of pain medication at 10:30 AM was not documented, I find this contemporaneous
witness statement believable. LPN Pollard asserts that R416 requested medication, but
the LPN could not provide it to R416 until four hours had passed between doses. LPN
Pollard says nothing about assessing R416 or attempting alternative interventions either
at 12:45 PM or at 2:30 PM. I assume that had LPN Pollard conducted an assessment or
26

attempted alternative interventions, he would have included that information in his
witness statement.

Several days later, on July 13, 2015, LPN Pollard completed a formal statement that he
signed under penalty of perjury. P. Ex. 29 at 26-27. In this new statement, LPN Pollard
asserted that when R416 complained of pain at 12:45 PM, he physically assessed R416 in
her room where he “observed a boil under her arm.” P. Ex. 29 at 26. Also in this
statement, LPN Pollard asserts that he repositioned R416 as a non-pharmacological
intervention to manager her pain at that time. However, Petitioner does not provide any
contemporaneous nursing notes documenting his assessment, interventions, and
effectiveness, and there is nothing indicating that R416 even had a boil. Importantly,
Petitioner did not offer LPN Pollard as a witness and CMS did not have the opportunity
to cross-examine him on his purported statement. I find LPN Pollard’s July 13, 2015
statement to be unsupported by the record. Both statements do indicate that LPN Pollard
only attempted alternative interventions prior to 2:30 PM because, essentially, the
physician order did not allow him to administer another does until 2:30 PM.

R416’s clinical record likewise did not reveal documentation indicating that staff
regularly conducted pain assessments and or followed-up to see if interventions were
effective, even though Petitioner had a care plan to address R416’s chronic pain. P. Ex.
29 at 3-7, 9-10. The care plan identified a number of non-pharmaceutical interventions
including: “Identify previous pain history and management of that pain and impact on
function. Identify previous response to analgesia including pain relief, side effects and
impact on function.”; “Monitor & report to Nurse, resident complaints of pain or requests
for pain treatment.”; and “Observe and report changes in usual routine, sleep patterns,
decrease in functional abilities, decrease [range of motion], withdrawal or resistance to
care to (specify physician and/or hospice nurse).”” CMS Ex. 22 Part A at 12-13.

Additionally, R416’s care plans identified non-pharmacological interventions including

sitting in the porch in warm sun; participation in activities; and repositioning her. CMS

Ex. 22 Part A at 14, 19. Staff even documented other interventions that were successful
in the past. Specifically, participating in activities and sitting outside on the porch in the
warm sun was effective in relieving her pain or taking her mind off the pain. Id.

Although the facility had developed an extensive care plan for R416’s pain, there is no
evidence that they used it. Without completed pain management forms, nursing notes, or
other medical records, there is no evidence that Petitioner attempted any alternatives or
documented effectiveness of either pharmacological or non-pharmacological
interventions.

Petitioner provided a copy of its administration of oral medication policy and procedure.
P. Ex. 29 at 31-32. In the policy and procedure, it instructs the nurse to chart “on MAR
according to policy.” It further instructs to “Chart on nurse’s notes: Pertinent
27

observations immediately after administration.” Jd. Nevertheless, nurses document the
time and their initials on the front of the MAR when they administer a medication to a
resident. CMS Ex. 22 Part A at 32, 40; P. Ex. 29 at 17, 18. Nurses use the rear of the
MAR, titled “PRN, STAT AND MEDICATIONS NOT ADMINISTERED” to document
medication anomalies, including as needed or PRN medications. This form provides
columns to document the date and hour the nurse provided the medication, the name of
the medication, the reason, result, and the initials of the nurse administering. See CMS
Ex. 22 Part A at 32, 40; P. Ex. 29 at 17, 18.

However, facility staff failed to correctly document the pain medication it provided to
R416. For example, the MAR indicated that nursing staff administered R416 Percocet
ten times on July 4, 2015. CMS Ex. 22 Part A at 40. (Fortunately, Petitioner’s staff did
not actually administer R416 ten doses of Percocet on that date.) The PRN, STAT and
Medications Not Administered form reflects another picture of how nursing staff
managed R416’s pain. It indicates that facility staff administered Percocet to R416 only
five times on July 4,. CMS Ex. 22 Part A at 31, 41.

Petitioner provided the pharmacy Controlled Medication Utilization Record for R416’s
Percocet. CMS Ex. 22 Part A at 44, 45; P. Ex. 29 at 20, 21. The pharmacy Controlled
Medication Utilization Record for R416’s Percocet administration is most likely to
accurately reflect the pain medication that Petitioner’s staff provided to R416 because
licensed nurses are required to count and sign out every controlled substance and requires
additional protections to obtain the medication and is frequently reconciled. Tr. 11/9 at
342-345.” R416’s medical record presents an inconsistent picture of how the facility
treated R416’s chronic pain. The chart below shows the number of Percocet tablets
Petitioner’s staff documented it administered to R416 between July | at 6:00 AM and
July 8 at 3:00 PM.

° As Surveyor Polakoski testified, the Controlled Medication Utilization Record involves
significant protocols. However, Petitioner also failed to comply with standard protocol.
Usually, at least two nurses are involved in reconciling the medication, often every time a
nurse administers a pill, or at least every shift. The Controlled Medication Utilization
Record contains a column titled “checked by” for a second nurse to sign indicating that
the remaining amount of the controlled substance is correct. Tr. 11/9 at 343-344.
However, Petitioner ignored the second nurse “checked by” column for reconciliation.
Petitioner’s management of its Controlled Medication Utilization Record is yet another
example of Petitioner’s lackluster adherence to nursing standards.
28

DATE | Controlled | MAR™] PRN, STAT and] Pain Flow Pain Flow
Medication Medications Not | Sheet obtained | Sheet obtained
Utilization Administered July 8 at 3:00 | July 9 at 9:30
Record!° form (rear of PM"? AM"*

MAR)?”

July 1 4 0 0 0 0

July 2 4 3 4 2 2

July 3 4 iW 3 2 2

July 4 5 10° 5 2 2

July 5 4 Ey 2 0 0

July 6 4 Ey 4 1 I

July 7 4 3 I 0 0

July 8 3 iy 4 0 2

Total: 33 n/a 23 7 10

“Because the MARs are illegible, the entries are approximate.

It is clear that Petitioner did not follow its policy requiring nursing staff to document the
administration of controlled pain medication to R416 when she experienced pain.
However, the facility is required to do much more than document administration. As
discussed, it must assess, attempt non-pharmaceutical interventions before
pharmaceutical interventions, monitor the effectiveness of the non-pharmaceutical
interventions, and if staff eventually administers medication, the facility is required to
monitor the resident for the effectiveness of the medication. See P. Ex. 29 at 30. The
Controlled Medication Utilization Record does not provide that information, nor does the
MAR, even if legible. The PRN, STAT and Medications Not Administered form
provides slightly more information; however, Petitioner’s policy requires the use of the
pain flow sheet, which does provide a place to record necessary information. However,
as the chart above demonstrates, Petitioner’s staff utilized this document only a
percentage of the time. Petitioner has not provided corresponding nursing notes that

'° CMS Ex. 22 Part A at 44-45; P. Ex. 29 at 20-21.

"| OMS Ex. 22 Part A at 32, 40; see P. Ex. 29 at 17, 18 (the MARs at P. Ex. 29 at 17 and
18 are labeled “re-written” but provide little, if any, clarity on the issue).

CMS Ex. 22 Part A at 31, 41; P. Ex. 29 at 19.
'S CMS Ex. 22 Part A at 33.

‘4 CMS Ex. 22 Part A at 43.
29

document the assessments, interventions, and outcomes to treat R416’s pain. Moreover,
her physician would certainly have a difficult time determining whether her pain
medication was effective.

As stated in Oxford Manor, “if facility staff exercise professional judgment in deciding
not to follow facility policy with respect to a particular resident, they document that
judgment and give a reason why not. In the absence of such contemporaneous
documentation, it is certainly reasonable to infer, when staff do not follow the policy,
either they are not aware of it or that they are simply disregarding it.” DAB No. 2167, at
5-6. Here, Petitioner has failed to point to contemporaneous documentation that shows
why the staff chose to not follow facility policy.

From July 1 through July 8, Petitioner administered R416 controlled pain medication 33
times. Even if I accept the altered pain flow sheet Petitioner provided on July 9 as
accurate, Petitioner still falls short. Taking the July 8 additions into account, Petitioner
still only assesses R416’s pain, attempts non-pharmaceutical interventions, evaluates
their effectiveness, and if necessary medication intervention, and evaluates their
effectiveness on managing R416’s pain — what is required — less than one third of the
time. I do not find Petitioner’s later entries in the pain flow sheet convincing. If the
surveyor truly took the pain flow sheet away from the LPN before he could document his
work (which in itself is in contravention with Petitioner’s policy), I could understand a
late entry for the 2:15PM July 8, 2015 medication. However, when reviewed in light of
the number of times the facility failed to document in the pain flow sheet according to its
policy, I find that Petitioner did not properly follow its policy and procedure when
addressing R416’s pain, on July 8, or beginning July | through July 8.

Petitioner also did not follow professional standards of nursing practice in this case.
Surveyor Polakoski explained professional standards of nursing practice related to PRN
(as needed) order for pain medicine. CMS Ex. 41 at 64-65. Professional standards of
nursing require the nurse to perform a pain assessment before administering medication
to ensure that the nurse is not administering unnecessary medication. Professional
standards of nursing also require the nurse attempt non-pharmacological interventions
prior to administering as needed pain medication. Professional standards of nursing also
require the nurse monitor the effectiveness of the medication after the nurse administers
the medicine because it is important to know whether the pain medication was actually
effective to relieve the indicated pain, because the staff may need to address the
resident’s pain in another way. It is also important to monitor the effectiveness of the
medication. The staff also needs to monitor (and of course document) the effectiveness
of an as needed pain medication because staff may need to consult the resident’s
physician who may need to prescribe a different dosage, a different pain medication, or
address the resident’s pain in another way. CMS Ex. 41 at 64-65.

30

Here, R416 was asking for pain medication not long after she was administered
medication. According to LPN Pollard, R416 was administered Percocet at 10:30 AM
and R416 began experiencing pain again by 12:45 PM. So in this case, it was particularly
important to assess R416’s different kinds of pain (e.g., general body pain, neck pain,
back pain, foot pain, leg pain), and monitor the effectiveness of all interventions, as well
as to document episodes of breakthrough pain. P. Ex. 29 at 25; CMS Ex. 22 Part A at 43.
Dr. Lesesne explained that without information about the relative effectiveness of the
Percocet in relieving R416’s pain, her physician would not be in a position to determine
whether Percocet continued to be appropriate at that particular dosage or whether
Percocet continued to be appropriate at all. CMS Ex. 41 at 11.

Both Dr. Lesesne and Surveyor Polakoski testified that the facility’s non-compliance
resulted in the potential for more than minimal harm to R416 and I agree. CMS Ex. 41 at
11, 66-67. Percocet is an opioid analgesic that physicians prescribe to relieve moderate
to moderately severe pain. CMS Ex. 39 Part A at 42. Dr. Lesesne explained that
unnecessary narcotic pain medication to R416 was additionally important in this case
because R416 had diagnoses of depression and psychosis, both of which narcotic pain
medication could exacerbate. CMS Ex. 41 at 11. It was important to determine if R416
was experiencing moderate pain or if they could manage her pain with a less aggressive
medication.

The prescribing information for Percocet cautions physicians when prescribing to the
elderly because of danger of cardiac or respiratory depression. However, “special risk
patients” include individuals with severe respiratory impairment, severe renal
impairment, or hypothyroidism. CMS Ex. 39 Part A at 44-45. R416 had chronic
obstructive pulmonary disease, chronic kidney disease, and hypothyroidism. Because
R416 was a special risk patient, it was particularly important to ensure that the
medication was necessary and to monitor effectiveness.

Additionally, Petitioner’s witness, Ms. Hirn, testified, “. . . if one document happens to be
confusing, a nurse can reconcile it with other narcotics records.” P. Ex. 33 at 10.
Surveyor Polakoski, a RN, explained that if a resident is experiencing issues, it is
standard nursing practice to consult the MAR, and not to compare various documents to
determine (or guesstimate) what medications facility staff administered. Surveyor
Polakoski explained that had R416 experienced any respiratory issues around July 4, as a
nurse, he would have checked the MAR and seen that the facility provided R416 ten
doses of Percocet — an overdose. Even if he were unsure if staff administered R416 ten
doses of Percocet, he would still need to treat R416 with the overdose protocol. Tr. 11/9
at 293-294, 297, 299-300.

Accordingly, I conclude that Petitioner has failed to meet its burden of proving by a
preponderance of the evidence that it provided the necessary care and services to R416.
31

Petitioner did not demonstrate that it was in substantial compliance with Medicare and
Medicaid participation requirements, in this instance, 42 C.F.R. § 483.25.

b. Petitioner was not in substantial compliance with 42 C.F.R.
§ 483.75() (1) (F514) because Petitioner failed to ensure clinical
records were correct for R405 when the resident’s clinical record
contained two orders for medication to be administered by mouth to a
resident who could not ingest anything by mouth and should have
received medication only through his PEG-Tube.

R405 was a 58-year-old male who Petitioner admitted to the facility on April 15, 2014,
and then readmitted after a hospitalization on February 19, 2015. His diagnoses included
Down’s syndrome, quadriplegia, acute respiratory failure, arthropathy, anxiety,
hypertension, hypotension, convulsions, sleep apnea, dementia, and senile dementia with
depressive features. He had a tracheotomy and a PEG tube. P. Ex. 25 at 1-2, 70-71.

R405’s most recent MDS with an assessment reference date of June 12, 2015, indicated
that he was not capable of being understood or of understanding others. He was not able
to speak. Although he could make eye contact, he was not able to follow commands.
Staff administered pain medication if it concluded he was agitated, which they interpreted
as R405 not feeling well. Tr. 11/18 at 175, 177-178. He received all of his nutrition and
medication through a PEG tube and was not to receive anything by mouth. P. Ex. 25 at
70-71, 78-79.

As early as February 19, 2015, the date of R405’s return from the hospital, R405’s
physician ordered that he receive nothing by mouth - including medication. CMS Ex. 22
Part F at 6, 9; P. 25 at 71. Indeed, Petitioner’s staff manually modified R405’s
physician’s order sheet to indicate that R405 was to receive the drug Aricept “via peg”
rather than by mouth. P. Ex. 25 at 31. However, on April 15, 2015, R405’s nurse
practitioner ordered 2 mg tablet of Glycopyrrolate to be administered “PO” (by mouth)
three times a day- at 6 AM, 2 PM, and 9 PM. P. Ex. 25 at 14.

Although this order was inconsistent with the physician’s order that R405 not receive
anything by mouth, the staff did not obtain a clarification order for the correct route of
administration. Instead, the staff promulgated the error in R405’s medical record,
including in his physician’s order sheet and his MAR as well. The record contains
R405’s May and July physician’s order sheets, both of which specify that on April 16,
2016 the doctor ordered 2 mg tablet of Glycopyrrolate to be administered “by mouth” at 6
am, 2 pm, and 9 pm. CMS Ex. 22 Part F at 6, 9 (emphasis added). The same order sheet
also indicated that on June 17, 2015, R405’s doctor ordered 0.5 mg Clonazepam to be
administered “by mouth” at bedtime for seizures, even though in March, the order sheet
correctly limited Clonazepam to administration through the PEG tube. CMS Ex. 22 Part
F at 6, 9. Rather than catching the error on the order, or the physician order sheets,

32

numerous staff continued to complicate matters by indicating with their initials on R405’s
MAR that they had provided the Glycopyrrolate as ordered (by mouth) from May
through July 2015, and the Clonazepam as ordered (by mouth) in July 2015. P. Ex. 25 at
44, 50, 58. It was not until July 7, 2015, when the surveyors brought the error to the
staff’s attention that Petitioner obtained a clarification order for administration by PEG
tube rather than by mouth. P. Ex. 25 at 92.

Petitioner was responsible for administering the facility in a manner that enables it to use
its resources effectively and efficiently to attain or maintain the highest practicable
physical, mental, and psychosocial well-being of each resident. 42 C.F.R. § 483.75. This
administrative obligation includes the requirement that the facility maintain clinical
records on each resident in accordance with accepted professional standards and practices
that are complete, accurately documented, readily accessible, and systematically
organized. 42 C.F.R. § 483.75(/)(1). In this case, Petitioner failed to maintain a complete
and accurate clinical record for R405. Specifically, Petitioner failed to ensure that the
medication orders for Clonazepam and Glycopyrrolate were accurate for R405. CMS Ex.
21 at 41-44.

Petitioner argued that this deficiency was frivolous because it could not pose a plausible
potential for harm because R405 is unresponsive, has orders to receive nothing by mouth,
and is incapable of swallowing. P. Post-Hrg. Br. at 44. Petitioner further asserts that
R405’s brother, who visited daily, would not have allowed a nurse to provide any
medication by mouth. P. Post-Hrg. Br. at 44. Petitioner also argued that Petitioner made
certain that they only assigned experienced nurses and nursing assistants who were
familiar with R405 to his care, and Petitioner assured that they did not assign registry
staff to care for him. P. Post-Hrg. Br. at 32, 44-45; P. Ex. 33 at 7; Tr. 11/10 at 265; Tr.
11/18 at 175-179, 186, 214. Nurse Hirn testified that the nursing staff was “very familiar
with [R405’s] condition” so it was “extremely unlikely” that any nurse would have
administered the medication by mouth. P. Ex. 33 at 7.

CMS argued that Petitioner did not deny that its documentation showed that R405 was to
receive the Glycopyrrolate and Clonazepam by mouth, simply that oral administration of
those medications was not likely to happen because Petitioner’s staff knew of R405’s
condition. CMS asserts that Petitioner could not guarantee that R405 would always be
cared for by nurses who were familiar with his condition, given employee turnover,
illnesses, and vacations. Further, CMS posits that the order to administer the medication
by mouth was in place long enough to have potentially resulted in oral administration of
the medication. CMS Post-Hrg. Br. at 40-41.

l agree with CMS that although Petitioner believes that it was not likely that its staff
would administer medication orally, had it done so, there is no doubt more than minimal
harm would have resulted. Therefore, Petitioner’s failure to maintain accurate clinical
records for R405 had the potential to cause him more than minimal harm.

33

Surveyor Dayton testified that because the incorrect physician orders persisted for such
an extensive period (at least since April 16, 2015) that this increased the potential that
R405 was subject to harm. Tr. 11/10 at 139-140; see CMS Ex. 22 Part F at 6. Surveyor
Dayton testified that there is an increased risk of harm every time a nurse administers the
medication, and because nurses are required to implement physician orders as written,
that risk of harm is intensified. Tr. 11/10 at 60-61, 63. This, of course, placed
Petitioner’s staff in the position of having to disobey an order to ensure R405’s safety.

In addition, Petitioner’s assertion that R405’s family members would intercede and stop
Petitioner’s staff from orally administering medication is not sufficient to overcome the
potential of more than minimal harm here. Although R405’s family visited daily (CMS
Ex. 22 Part E at 44), Petitioner cannot rely on a resident’s family to ensure safe
administration of medication.

Further, Petitioner’s staff development coordinator explained that the physician’s order
sheets and MAR come from the pharmacy at the end of every month. Once Petitioner
receives these records, a facility staff member reviews the records for accuracy and then
an additional staff member double-checks them for accuracy. The staff development
coordinator said she was unaware of how the inaccurate “Physician’s order sheet” and
MAR were missed during the checking process. CMS Ex. 21 at 44; CMS Ex. 43 at 22.
This further indicates a more systemic problem; that the systems in place were not
sufficient to detect such glairing errors, by not one, but two of Petitioner’s staff members
~in addition to each nurse who documented providing the medication. Therefore,
Petitioner did not demonstrate that it was in substantial compliance with Medicare and
Medicaid participation requirements at 42 C.F.R. § 483.75(/)(1).

5. CMS was required to terminate Petitioner’s provider agreement for failing to
be in substantial compliance with Medicare program participation
requirements on July 9, 2015, and for six months preceding that date.

The Act only permits the Secretary to continue to provide Medicare program
reimbursements to an SNF for a maximum of six months when the SNF is not in
compliance with the Act’s requirements for SNFs. Act §1819(h)(2)(C), 42 U.S.C.

§ 1395i-3(h)(2)(C). Consistent with this, the regulations require CMS to terminate an
SNF’s participation in the Medicare program if they are not in substantial compliance for
a six-month period, even if the SNF’s deficiencies do not place residents in immediate
jeopardy. 42 C.F.R. § 488.412. Once CMS demonstrates that a facility is out of
substantial compliance, the burden shifts to the facility to demonstrate its return to
substantial compliance. Premier Living & Rehab. Ctr., DAB No. 2146 at 23 (2008).
Therefore, if CMS has shown, and Petitioner has failed to rebut, that Petitioner was not in
substantial compliance with even one program participation requirement with the
potential for more than minimal harm, (at the scope and severity of level “D” or above)
during a six month period, Petitioner must be found to have not been in substantial
34

compliance with the applicable requirement and CMS’s determination to terminate
Petitioner must be upheld. See Beverly Health & Rehab. Servs., Inc. v. Thompson, 223 F.
Supp. 2d 73, 111 (D. D.C. 2002).

As indicated above, Petitioner did not demonstrate that it returned to compliance at some
point prior to July 8, 2015. As concluded above, Petitioner had not fully returned to
substantial compliance following the April 30, 2015 survey by June 2, 2015, and
remained out of substantial compliance with at least one program requirement in both the
June 11, 2015 (42 C.F.R. §§ 483.25 and 483.25(e)(2)) and the July 9, 2015 (42 C.F.R.

§§ 483.25 and 483.75(1)(1)) surveys. Accordingly, CMS was required to terminate
Petitioner’s provider agreement effective July 8, 2015, and I must uphold that
termination.

6. CMS was required to impose a denial of payment for new admissions
(DPNA) not later than April 8, 2015, because Petitioner failed to return to
substantial compliance over the preceding three months.

CMS imposed a DPNA beginning April 8, 2015, based on the January and March
surveys. CMS Ex. 29 at 2. Although Petitioner now challenges the DPNA, that remedy
is administratively final. CMS may impose a DPNA any time there is a breach of
substantial compliance, 42 C.F.R. § 488.417(a), and must impose a DPNA if the facility
as not returned to substantial compliance within three months. Act § 1819(h)(2)(A)(ii),
(B), 42 U.S.C. § 1395i-3(h)(2)(A)(1i) (circumstances permitting DPNA), implemented at
42 CFR. § 488.417(a); Act § 1819(h)(2)(D), (E) 42 U.S.C. § 1395i-3(h)(2)(D), (E)
(circumstances requiring DPNA), implemented at 42 C.F.R. § 488.417(b).

Here, Petitioner did not challenge the January 8, 2015 survey findings of substantial
noncompliance; therefore, Petitioner was not in substantial compliance on January 8,
2015. The statute requires CMS to impose a DPNA if Petitioner cannot demonstrate that
it returned to substantial compliance within three months, specifically by April 8,

2015. But Petitioner also did not challenge the findings of substantial noncompliance
from the March 2, 2015 survey, which found continued compliance from the January
survey; nor did it challenge the April 30, 2015 survey, which again found continued
noncompliance. CMS Ex. 33. In fact, Petitioner did not substantially comply with the
participation requirements for a single day of this survey cycle, and remained out of
compliance with the quality of care requirement at 42 C.F.R. § 483.25 throughout the
survey cycle and its eventual termination. CMS Exs. 1, 10, 13. Accordingly, Petitioner
did not demonstrate that it returned to substantial compliance at any point between
January 8 and April 8. CMS Ex. 33; P. Ex. 8. Therefore, CMS lawfully was required to
impose a DPNA effective April 8, 2015.

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7. The CMP CMS imposed for the period between June 11, 2015, and July 7,
2015, is reasonable.

In determining whether the CMP amounts imposed against Petitioner are reasonable, I
apply the factors listed in 42 C.F.R. § 488.438(f). 42 C.F.R. § 488.438(e)(3). These
factors include: (1) the facility’s history of compliance; (2) the facility’s financial
condition; (3) the factors specified at 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 at 42 C.F.R.

§ 488.404 include: (1) the scope and severity of the deficiency; (2) the relationship of the
deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior
history of noncompliance in general and specifically with reference to the cited
deficiencies. Unless a facility contends that a particular regulatory factor does not
support the CMP amount, the ALJ must sustain it. Coquina Ctr., DAB No. 1860, at 32
(2002).

In the present case, CMS imposed a CMP based on the March 2 survey at $5,150 per-day
beginning February 6, 2015, through February 24, 2015, and $750 per-day thereafter.
CMS continued the CMP through July 7, 2015, based on its determinations that Petitioner
remained out of compliance with the Medicare participation requirements. Petitioner
does not dispute the January, March, or April surveys, or the remedies associated with
this noncompliance. Accordingly, the $5150 per-day CMP from February 6, 2015,
through February 24, 2015, and $750 per-day CMP from February 25, 2015, through
June 11, 2015 are administratively final. Although Petitioner generally contests the CMP
associated with the June and July surveys of $750 per-day from June 11, 2015, through
July 7, 2015, Petitioner provides no specific argument related to the amount of the CMP.

Petitioner has an extensive history of noncompliance. Petitioner has had many repeated
deficiencies. Nor does Petitioner appear to learn from prior deficits. In the January
survey, surveyors cited Petitioner for F441. Rather than correcting that deficiency, on
revisit, Petitioner again violated F441, this time at the immediate jeopardy level. Also,
during the January survey, surveyors cited Petitioner for F224 and F312 noncompliance
that did not amount to immediate jeopardy. Rather than resolve these issues, on the
revisit, surveyors found that Petitioner violated the same provisions; however, this time
they were at the level of actual harm. Petitioner’s compliance history includes a total of
four actual harm deficiencies, which were in addition to two immediate jeopardy
citations. In addition to many repeat deficiencies, Petitioner had two repeat deficiencies
cited in each of the four surveys in this survey cycle. CMS Exs. 1, 10, 13.

In regard to consideration of Petitioner’s financial condition, I cannot conclude that this is
a reason to reduce the penalty amount in this case. The record neither contains any
information about Petitioner’s financial condition nor has Petitioner even argued that I
should consider its financial condition as a basis to reduce the CMP.
36

I consider Petitioner to have a medium degree of culpability in this case. Although the
deficiencies in the June and July surveys were not at the immediate jeopardy level,
Petitioner’s violations were still significant. Petitioner’s facility did not provide the
necessary care and services to its residents, which is central to a facility’s participation in
the Medicare program. Medicare pays for placement in a SNF specifically so that
residents can receive the care they need. Petitioner repeatedly failed to provide that
needed care.

Since Petitioner provides no specific argument concerning the amount of the CMP, and
after considering the factors in the regulations, I conclude that the CMP amounts imposed
in this case are reasonable. A per-day CMP may range from $50 to $3,000 per-day for
noncompliance that does not amount to immediate jeopardy to the health and safety of
residents. 42 C.F.R. § 488.438(a). Here, CMS imposed a $750 per-day CMP, which is in
the lower end of available penalty. This penalty amount is reasonable.

V. Conclusion

I conclude that Petitioner was not in substantial compliance with program requirements at
42 CFR. §§ 483.25, 483.25(m)(2), 483.25(e)(2), and 483.75(/)(1), based on the surveys
concluding on June 11, 2015 and July 9, 2015, and I further conclude that Petitioner was
not in substantial compliance with Medicare program requirements for a six month
period. Accordingly, CMS was required to terminate Petitioner’s provider agreement as
a skilled nursing facility in the Medicare program and impose a DPNA. Finally, I
conclude that a $750 per-day CMP from June 11, 2015, through July 7, 2015, is
reasonable.

/s/
Scott Anderson
Administrative Law Judge