Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Golden Living Center — Heber Springs
(CCN: 04-5158),

Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-08-560
Decision No. CR2280

Date: November 10, 2010

DECISION

Petitioner, Golden Living Center — Heber Springs, was not in substantial compliance with
program participation requirements on or about March 3, 2008, due to a violation of 42 C.F.R. §
483.25! as alleged by a survey of Petitioner’s facility completed on April 4, 2008. There is a
basis for the imposition of an enforcement remedy. A per instance civil money penalty (PICMP)
of $6,000 is not reasonable, but a $3,000 PICMP is reasonable.

I. Background

Petitioner is located in Heber Springs, Arkansas, and participates in Medicare as a skilled nursing
facility (SNF) and the state Medicaid program as a nursing facility (NF). On April 4, 2008,
Petitioner was surveyed by the Arkansas Department of Health and Human Services, Office of
Long-Term Care (state agency) and found not in compliance with program participation
requirements. The Centers for Medicare and Medicaid Services (CMS) notified Petitioner by
letter dated April 22, 2008, that it was imposing the following enforcement remedies: termination
of Petitioner’s provider agreement effective July 4, 2008, and a denial of payment for new

' All references to the Code of Federal Regulations (C.F.R.) are to the 2007 version in effect at
the time of the survey, unless otherwise indicated.
2
admissions (DPNA) effective May 7, 2008, if Petitioner did not return to substantial compliance
before those dates; a PICMP of $6,000, based upon an alleged violation of 42 C.F.R. § 483.25;
and withdrawal of approval to conduct a nurse aide training and competency evaluation program
(NATCEP) for two years from the date the survey ended.? CMS notified Petitioner by letter
dated June 11, 2008, that the state agency determined by a revisit survey that Petitioner had
returned to substantial compliance with program participation requirements, and the termination
and DPNA remedies were rescinded. The parties agreed at hearing that the revisit survey found
that Petitioner returned to substantial compliance on May 1, 2008. Tr. at 36.

Petitioner requested a hearing before an administrative law judge (ALJ) by letter dated June 17,
2008. The case was assigned to me for hearing and decision on July 22, 2008, and an
Acknowledgement and Prehearing Order was issued at my direction. On March 3 and 4, 2009, a
hearing was convened in Little Rock, Arkansas, and a transcript (Tr.) of the proceedings was
prepared. CMS offered CMS exhibits (CMS Exs.) | through 23 that were admitted as evidence.
Tr. at 19. Petitioner offered Petitioner exhibits (P. Exs.) 1 through 29 that were admitted as
evidence. Tr. at 22, 187. CMS called the following witnesses: Surveyor Linda Corbin, RN, and
Dorothy Beckley Doughty, RN, who was qualified as an expert witness. Petitioner called the
following witnesses: Terrie Coughlin, Licensed Practical Nurse (LPN); Sara Kilburn, RN,
Petitioner’s Director of Nurses (DON); and Charles Pound, M.D., who was called as an expert
witness. The parties filed post-hearing briefs and post-hearing reply briefs.

II. Discussion
A. Issues
The issues in this case are:

Whether there is a basis for the imposition of an enforcement remedy;
and
Whether the remedy imposed is reasonable.

B. Applicable Law

The statutory and regulatory requirements for participation by a long-term care facility are found
at sections 1819 (SNF) and 1919 (NF) of the Social Security Act (Act) and at 42 C.F.R. Part 483.
Section 1819(h)(2) of the Act vests the Secretary of Health and Human Services (Secretary) with
authority to impose enforcement remedies against a SNF for failure to comply substantially with

> Petitioner did not have a NATCEP. Tr. at 35. However, based upon the survey and
enforcement remedy in this case, the state agency would be unable to approve such a program to
be offered by Petitioner within a period of two years from the last date of the survey. 42 C.F.R. §
483.151(b)(2) and (e)(1).
3
the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.
Pursuant to 1819(h)(2)(C), the Secretary may continue Medicare payments to a SNF not longer
than six months after the date the facility is first found not in compliance with participation
requirements. Pursuant to 1819(h)(2)(D), if a SNF does not return to compliance with
participation requirements within three months, the Secretary must deny payments for all
individuals admitted to the facility after that date — commonly referred to as the mandatory or
statutory DPNA. In addition to the authority to terminate a noncompliant SNF’s participation in
Medicare, the Act grants the Secretary authority to impose other enforcement remedies, including
a discretionary DPNA, civil money penalties (CMP), appointment of temporary management, and
other remedies such as a directed plan of correction. Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a
long-term care facility that is not complying substantially with federal participation requirements.
“Substantial compliance means a level of compliance with the requirements of participation such
that any identified deficiencies pose no greater risk to resident health or safety than the potential
for causing minimal harm.” 42 C.F.R. § 488.301 (emphasis in original). A deficiency is a
violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or
the Secretary’s regulations at 42 C.F.R. Part 483, Subpart B. State survey agencies survey
facilities that participate in Medicare on behalf of CMS to determine whether the facilities are
complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-.335. The
regulations specify the enforcement remedies that CMS may impose if a facility is not in
substantial compliance with Medicare requirements. 42 C.F.R. § 488.406.

CMS may impose a per day CMP for the number of days a facility is not in substantial
compliance, or for each instance of noncompliance. 42 C.F.R. § 488.430(a). The regulations
specify that a CMP that is imposed against a facility on a per day basis will fall into one of two
ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050 per day
to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s
residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1)(i),
(d)(2). “Immediate jeopardy means a situation in which the provider’s noncompliance with one
or more requirements of participation has caused, or is likely to cause, serious injury, harm,
impairment, or death to a resident.” 42 C.F.R. § 488.301 (emphasis in original). The lower range
of a CMP, $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute
immediate jeopardy but either cause actual harm to residents, or cause no actual harm, but have
the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). A PICMP may
range from $1,000 to $10,000, and the range is not affected by the presence of immediate
jeopardy. 42 C.F.R. § 488.438(a)(2).

> Section 1919(h)(2) of the Act gives similar enforcement authority to the states to ensure that
NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of
the Act.
4

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

The standard of proof, or quantum of evidence required, is a preponderance of the evidence.

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

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.
CMS alleges based upon the survey that ended April 4, 2008, that Petitioner was not in
substantial compliance with program participation requirements, based upon a violation of 42
C.F.R. § 483.25 (Tag F309, scope and severity J). CMS proposes to impose a $6,000 PICMP
based upon the alleged violation. The alleged violation of 42 C.F.R. § 483.25 is the only
deficiency from the survey that is subject to my review, as it is the only deficiency for which
CMS imposed an enforcement remedy.
5
I have carefully considered all the evidence, including the documents and the testimony at
hearing, and the arguments of both parties, though not all may be specifically discussed in this
decision.’ I discuss the credible evidence given the greatest weight in my decision-making. The
fact that evidence is not specifically discussed should not be considered sufficient to rebut the
presumption that I considered all the evidence and assigned such weight or probative value to the
credible evidence that I determined appropriate within my discretion as an ALJ. There is no
requirement for me to discuss the weight given every piece of evidence considered in this case,
nor would it be consistent with notions of judicial economy to do so.

1. Petitioner violated 42 C.F.R. § 483.25 (Tag F309).

2. Petitioner’s violation of 42 C.F.R. § 483.25 did not cause actual harm or
pose immediate jeopardy but there was a risk for more than minimal harm,
and, therefore, Petitioner was not in substantial compliance due to the
violation.

a. Facts

Resident 14 was a 44-year-old man admitted to Petitioner’s facility on December 10, 2007.
Resident 14 had a history of spina bifida and lower limb full-thickness skin loss on the plantar
surface of his left foot. P. Exs. 5, 6, 19.° Following treatment in the hospital for his left foot
wound, Resident 14 was discharged to Petitioner for rehabilitation. P. Ex. 6, at 3-4. Resident
14’s Minimum Data Set (MDS) with an assessment reference date of December 17, 2007,
documented that the resident was independent in cognitive skills for daily decision-making, and
he was responsible for himself. In addition, he: was usually continent of bowel; was continent of
bladder; had an indwelling catheter; required extensive assistance with toileting; had moderate
pain less than daily and in the past fourteen days; and had received monitoring for an acute
medical condition. The MDS shows that the resident did not participate in his assessment, and he
had no family or significant other that participated. P. Ex. 9. Resident 14’s MDS with an
assessment reference date of February 5, 2008, documented, among other things, that the resident:
was independent in his cognitive skills; incontinent of bowel; continent of bladder; had an

* “Credible evidence” is evidence that is worthy of belief. Blacks Law Dictionary 596 (18" ed.
2004). The “weight of evidence” is the persuasiveness of some evidence compared to other
evidence. Jd. at 1625. Evidence that is not credible generally has no probative value or weight.
Evidence that is credible may or may not be given probative value or weight based upon its
comparison with other evidence of record.

> The record is conflicting as to the cause of the left foot wound, as the record shows it was either
a burn or caused by a splint he wore on that foot. P. Exs. 6, at 1; 19. A physician’s progress note
dated January 30, 2008, reflects wounds on both feet caused by braces. P. Ex. 17, at 1. The DON
testified that the wound was due to rubbing caused by a brace. Tr. at 233.
6
indwelling catheter; required limited assistance of one person with toileting; had mild pain less
than daily; and, in the past 14 days, had received monitoring for an acute medical condition.
CMS Ex. 10; P. Ex. 11.

Testimony at hearing was that Resident 14 had undergone a number of urologic procedures,
which included some sort of devices being implanted in the past. Tr. at 140; Tr. at 255-60; 262.
Neither the government expert, RN Doughty, nor the Petitioner’s expert, Dr. Pound, was certain
of the prior procedures or implants. There is a dearth of documentary evidence reflecting the
actual history of urologic procedures. However, Resident 14 reported to emergency room
personnel on March 6, 2008, that he had a history of placement of a penile sling. P. Ex. 22, at 2.
Resident 14’s urologist, Dr. Diaz, indicated that Resident had an AdVance male sling® placed in
2007 and that he had had multiple spinal surgeries. P. Ex. 22, at 6.

Resident 14 was assessed as requiring a care plan for his indwelling catheter. P. Ex. 10. His care
plan dated December 21, 2007, reflects an assessed risk for urinary tract infection (UTI) due to
the indwelling catheter that was required due to his spina bifida. Interventions required by the
care plan included observing the catheter and changing the catheter and tubing every 30 days,
and, as necessary: observing collected urine for sediment, cloudiness, odor, blood, and amount;
reporting any problems with urine or fever promptly to the physician; encouraging fluids;
monitoring laboratory reports as ordered; and perineal care every shift and as necessary. P. Ex.
12, at 1; CMS Ex. 5, at 1. The plan of care was reviewed on January 17, 2008, and the
determination was made that it would be continued for 90 days. CMS Ex. 5, at 1, 12; P. Ex. 12,
at 1. I have received no evidence that the interventions required by that care plan were changed
prior to Resident 14 departing the facility on March 6, 2008.” Tr. at 78.

The evidence shows that for most of his stay with Petitioner, Resident 14 had an indwelling or
Foley catheter. Physician orders support a finding that he had a Foley except February 4 or 5 to
February 9, 2008, and February 21 and 22, 2008. The nurse’s notes indicate that the resident was
also self-catheterizing on February 13, 2008. *

Physician Orders forms show that a Foley catheter was ordered December 12, 2007 (P. Ex. 15, at
2). An order dated February 4, 2008, required that the Foley be discontinued when in-out
catheters arrived at the facility (P. Ex. 15, at 3, 4). An order dated February 9, 2008 required that
a 14 French Foley catheter be placed and changed monthly and as necessary (P. Exs. 15, at 4; 16,
at 3). An order dated February 13, 2008, required a 16 French Foley catheter (P. Ex. 15, at 4).

® P. Ex. 23; CMS Ex. 21.

7 The SOD does not charge Petitioner for failing to update or follow Resident 14’s care plan, and
I do not find a violation or deficiency where none is charged.

* The resident used a device known as a straight catheter for self-catheterizing. A straight
catheter is also referred to as an in-out or in-and-out catheter. Tr. at 190-91.
7
An order dated February 19, 2008, required Foley care with soap and water every shift (P. Ex. 16,
at 3). An order dated February 20, 2008, required that the Foley be discontinued on February 21
(P. Exs. 15, at 4; 20, at 3), and orders dated February 22, 2008, required an 18 French Foley
catheter with a 30 cc bulb to be changed monthly or as necessary (P. Exs. 16, at 3; 21, at 3-4).
Resident 14 had a physician order dated December 11, 2007, for Hydrocodone every four hours
as needed for pain associated with the full-thickness skin loss on his lower limb. P. Exs. 15, at 3;
16, at 3; 20, at 5; 21, at 6; CMS Ex. 9, at 7-8. I have no evidence of an order for the
administration of Hydrocodone for bladder or scrotal pain.

Nurses’ notes from December 14, 2007 to February 5, 2008, indicate that Resident 14
consistently had a Foley catheter in place. P. Ex. 13. Nurse’s notes entries on February 5, 2008,
show that the resident’s Foley catheter was changed; however, subsequently, the resident
requested that the Foley catheter be removed, and it was discontinued at his request. There is no
indication the physician was consulted. P. Ex. 13, at 33. A nurse’s notes entry dated February 6,
2008 at 12:22 a.m. states that the resident self-catheterizes every two hours and as necessary. P.
Ex. 13, at 34. Nurse’s notes through February 8, 2008, indicate that the resident continued to
self-catheterize. P. Ex. 13, at 35. However, a nurse’s notes entry dated February 11, 2008 at
11:31 a.m. indicates that the resident has a Foley catheter again. An entry at 11:08 p.m. on
February 11, 2008, shows that the resident requested that the Foley catheter be discontinued. A
new order to discontinue the Foley was obtained from the physician, and the Foley was drained
and clamped. A nurse’s notes entry dated February 12, 2008 at 3:55 a.m. indicates that the
resident self-catheterizes every two hours and as necessary. However, a note dated February 12,
2008 at 10:53 p.m. indicates that the resident was undergoing bladder training and that the Foley
was being unclamped and drained every two hours. The notes indicate that the resident wanted to
continue bladder training throughout the night and have the Foley removed in the morning. A
nurse’s notes entry dated February 13, 2008 at 10:41 p.m. indicates that the resident complained
that he could not get enough urine out self-catheterizing. A new order for a Foley catheter was
obtained from the physician, and the Foley was placed. P. Ex. 13, at 37, 39. A nurse’s notes
entry on February 20, 2008, indicates that the resident continued with the Foley catheter in place.
P. Ex. 13, at 32. Notes show that the Foley was removed on February 21, 2008, per physician
order, and staff was to monitor output. A note dated February 22, 2008, shows that the Foley was
reinstated at the resident’s request after staff obtained a new physician’s order. P. Ex. 13, at 41.
A nurse’s notes entry on February 26, 2008, shows that the resident was out for an appointment
with the urologist, that he was upset in the van when returning from the appointment and crying
while speaking with someone on the phone, and that he told staff that he was upset because he did
not receive the answer he wanted.” P. Ex. 13, at 44. The nurse’s notes show that the resident

° A physician’s progress note dated February 27, 2008, states that the resident was back from his
appointment with his doctor in Little Rock (the appointment appears to have been with the
urologist) and that the resident would ultimately need to have an implant surgically removed after
his foot healed. P. Ex. 17, at 2-3. The type of implant was not specified, but this may have been
the cause for the resident’s emotional reaction following his appointment. Tr. at 263.
8
continued to have a Foley from February 22, 2008 to sometime on March 3, 2008. P. Ex. 13, at
41-46.

On March 3, 2008, Resident 14 underwent a cystoscopy, a minor surgical procedure that involved
direct visual examination of the interior of his bladder by means of a small, lighted telescope. P.
Ex. 18, at 2; Tr. at 263-64. Post-operative instructions indicate that a small amount of blood in
the urine would not be unusual and that the physician should be notified if the amount of blood
becomes excessive or there is difficulty voiding. P. Ex. 18, at 2. Additional instructions
following surgery were to observe the area for signs of excessive bleeding and signs of infection,
including increased pain, redness, swelling, and foul odor. Nursing personnel were to reinsert the
Foley catheter if the resident was unable to urinate. P. Ex. 18, at 1. It is apparent that the Foley
catheter would have been removed to perform the cystoscopy (Tr. at 263-64), and the post-
operative instruction form supports an inference that the resident was intended to be returned to
Petitioner without a Foley catheter in place. The evidence shows that the resident received
Hydrocodone at 9:00 p.m., but the location of his pain is not indicated. CMS Ex. 9, at 10. The
nurse’s notes from the morning of March 4, 2008, show that a Foley catheter was placed for the
resident. P. Ex. 13, at 47.

A nurse’s note dated March 4, 2008 at 3:44 a.m. indicates that the resident requested that a Foley
catheter be “replaced” but the nurse could not do so, because she did not have a Foley of the
correct size. P. Ex. 13, at 46. A nurse’s note dated March 5, 2008 at 3:03 p.m. states it is a late
entry for March 4, 2008 at 3:00 a.m. and that a nurse inserted a Foley catheter for Resident 14 at
is request, because he could not void sufficiently. Approximately three hours later, the resident
complained that he was having urine leakage and that he did not think the catheter bulb was in the
correct position. The nurse deflated and repositioned the bulb and then refilled the bulb, and the
resident said it felt better. P. Ex. 13, at47. The evidence shows that Resident 14 was given
Hydrocodone at 6:00 a.m. and 10:00 a.m. on March 4, 2008, and the 6:00 a.m. dose was for a
complaint of bladder pain. CMS Ex. 9, at 8, 10. He received another Hydrocodone for a
complaint of scrotal pain around 8:00 a.m. on March 5, 2008. He rated the pain as four, which is
mild pain on Petitioner’s scale. At 9:10 a.m., the resident rated the pain as two, which is still mild
pain. Resident 14 wanted his physician called. CMS Ex. 9, at 9, 10. He was given another
Hydrocodone at 1:00 p.m. on March 5, 2008. CMS Ex. 9, at 10. A nurse’s note dated March 5,
2008 at 3:10 p.m. indicates that the resident complained of swelling in his groin and that a nurse
ad repositioned the catheter the previous night. The resident said it felt better for a while. The
note indicates that the resident asked that his physician be called. The note shows that LPN
Terrie Coughlin called the physician and explained the resident’s complaint to the physician’s
nurse who said she would call back. The physician’s nurse called back with a new order for
Detrol, because the resident was probably having bladder spasms. The note indicates that LPN
Coughlin informed the resident of what the physician’s nurse said, and he understood. P. Ex. 13,
at 47. A nurse’s note dated March 5, 2008 at 9:32 p.m. indicates that a Foley was in place. P. Ex.
13, at 46.

Resident 14 was given a Hydrocodone at 6:30 a.m. on March 6, 2008, but the record before me
does not indicate the location of his complaint of pain that caused him to be given the pain
medication. CMS Ex. 9, at 10. A nurse’s note dated March 6, 2008 at 1:12 p.m. states that
9
Resident 14 had been up in the morning propelling around the facility
and talking with staff. He told LPN Coughlin that he continued to fee!
in his scrotal area. The note states that no visual edema was noted an
drain yellow urine. The note states that, at 10:45 a.m., LPN Coughlin

in his wheelchair, laughing
there was some swelling

that the Foley continued to
was called to Resident 14’s

room, and she immediately saw bright red blood in his Foley catheter tubing. Resident 14 stated

that he was swollen more, and LPN Coughlin records that she observe

d that the scrotal area was

very swollen. The note shows that Resident 14 was sent to the emergency room. P. Ex. 13, at 47.

There is no dispute that Resident 14 never returned to Petitioner’s faci

ity.'°

On March 6, 2008, Resident 14 was transported to the emergency room. The emergency room
report dated March 6, 2008, with a time of service of 11:50 a.m., shows that Resident 14 arrived
with complaints of severe scrotal pain, penile swelling with severe pain and blood visible in his

urine. It is reported that Resident 14 told emergency room personnel t
suddenly when he felt like “something dropped.” P. Ex. 22, at 2. The

hat his symptoms started
genitourinary examination

in the emergency room revealed that the Foley catheter was in place, t

ere was visible blood in

the catheter bag, and there was swelling with hematoma to the scrotum and penis with “exquisite
tenderness.” P. Ex. 22, at 3. The emergency room diagnoses were: torn urethra; scrotal

hematoma; and frank hematuria (visible blood in the urine). P. Ex. 22.
urologist was Edwin Diaz, MD. Dr. Diaz’s description of the resident
Resident 14’s emergency room admission, included the following:

This is a patient of mine. He is a 44-year-old patient wh
bifida and life-long urinary incontinence. He underwent
Avance (sic) male sling last year. He is completely dry.
admitted to rehab in November because of a left foot ule

, at 4. Resident 14’s
’s history, on the day of

0 has spina
and (sic)
He was

er. They put

in a catheter and it has been in there ever since with multi-changes.
When they tried to remove the catheter recently he was unable to
urinate. I did a cysto in the office. It showed no evidence of mesh

erosion. He had a catheter placed by the nursing home s

taff recently

and either the balloon is blown up in the urethra or the catheter was

pulled on and it damaged the urethra but at any rate he h

as a urethral

perforation causing the swelling of his scrotum and penis. A

suprapubic tube was placed by Dr. Ken Robins the urine

is clear and

yellow and when he did a cystogram it showed the Foley balloon to be

in the urethra.

P. Ex. 22, at 6. Dr. Diaz, as Resident 14’s treating urologist, was most familiar with the resident

and his history of urologic problems, and I find his opinions weightier

'° On March 11, 2008, five days after being admitted to the hospital, t

than those of the experts

he resident underwent

scrotal debridement and removal of his testes due to gangrene and necrotizing fasciitis. CMS Ex.

19, at 7.
10
called by the parties in this case who admitted that they did not have the resident’s complete
history and had no opportunity to examine the resident. Dr. Diaz’s report establishes that an x-ray
of the bladder (cystogram) showed that the Foley catheter balloon was in the urethra. Dr. Diaz
stated two possible causes, either the balloon was inflated in the urethra or the catheter was pulled
on, which pulled the balloon into the urethra. Surveyor Corbin testified that she interviewed the
resident’s urologist, Dr. Diaz, at the hospital during the survey, and he opined that the resident’s
injury was due to inflating the balloon in the urethra, causing trauma, or the tubing was dislodged,
causing trauma, but he did not know which occurred. Tr. at 88. The resident’s clinical record in
evidence before me shows that the catheter was placed on March 4, 2008, in the morning.
Between the insertion of the catheter on March 4 and the morning of March 6, 2008, the resident
complained of urine leakage that was resolved by repositioning the catheter, and he complained
of a feeling of swelling in his scrotum. On the morning of March 6, 2008, the nurse’s note shows
that he was laughing and talking with staff. However, about 10:45 a.m., Resident 14 complained
of more swelling, and there was visible blood in his catheter tubing. The emergency room record
shows that the resident was complaining of extreme pain. I find that this evidence is consistent
with Dr. Diaz’s opinion that the catheter tubing was pulled, and the bulb was pulled into and
ruptured the resident’s urethra around 10:45 a.m. on March 6, 2008, causing the sudden onset of
blood in the urine and pain. The evidence is not consistent with a finding that staff inflated the
bulb of the catheter in the resident’s urethra on either March 4 or 5.'' Resident 14’s treating
physician, Granville Vaughn, MD, opined in his affidavit dated March 3, 2009, that if the balloon
of the catheter was inflated in the urethra, the resident would have had a sudden onset of
excruciating pain, and he did not complain of pain on March 4 or 5, 2008. P. Ex. 29.

Petitioner called Terrie Coughlin, LPN, to testify. She testified that she worked for Petitioner on
the 6:00 a.m. to 2:00 p.m. shift and that she was Resident 14’s primary care-giver. She described
the resident as independent and well-groomed. She noted that he: did a lot of his own care; was
alert and oriented; could self-transfer; had a lot of upper body strength; and could state if he was
in pain or had discomfort. He used a straight catheter himself to urinate. He wanted privacy
when he used the catheter. If he felt he was not getting sufficient output using the straight
catheter, he requested a Foley catheter. Dr. Vaughn was his primary care physician. On March 4,
2008, LPN Stacy Hewitt called her just as she was clocking-in and asked for assistance to insert a
catheter into Resident 14. LPN Coughlin testified that the catheter was already in his penis, the
area was draped, and she washed and put on gloves. The resident told her he had just used the
straight catheter. LPN Coughlin completed inserting the Foley, and the resident reported no
discomfort. She inflated the bulb, and she finished gathering the equipment. The resident was
fine, and he dressed and went into the hall. LPN Coughlin testified that she had inserted Foley

'' An infectious disease consultation by Susan Delap, MD, dated March 8, 2008, suggests that

the placement of the catheter at Petitioner caused the torn urethra. However, she also states that
she was unsure of whether it was the insertion of a Foley catheter or an in-out catheter that caused
the tear, and she noted that Resident 14 was a fairly poor historian. CMS Ex. 19, at 1, 3. Dr.
Delap’s statements suggesting that the insertion of a catheter by Petitioner’s staff caused the
urethral tear are inconsistent with evidence of record before me and are not considered weighty.
11
catheters many times. She testified that she knew that the resident had several sizes of catheters
due to problems with leakage. She testified that a physician has to order the catheter to be used.
The resident could not urinate without a catheter. The resident’s normal practice was to
catheterize himself. LPN Coughlin identified the nurse’s note for March 5, 2008 at 3:03 p.m. (P.
Ex. 13, at 47) as her note that was a late entry for March 4, 2008, but that “3:00 a.m.” was a
typographical error, as she did not get to work until about 5:45 a.m. She testified that the note
referred to her placing the catheter on March 4 when LPN Hewitt requested her assistance. She
said that, as the note reflects, after about three hours, he complained that the bulb felt like it was
only 10 cc’s’” and that he was having leakage. She testified that she looked at his brief and there
was no wetness, and she looked at the genitals and saw no swelling, redness, or edema. She
testified that she went ahead and deflated the bulb, repositioned and re-inflated it, and the resident
said it felt better. The resident did not complain of any swelling or discomfort. LPN Coughlin
identified the nurse’s note dated March 5, 2008, at 3:10 p.m. as her note (P. Ex. 13, at 47) and
testified that the time was when she was writing the note at the end of her shift. She testified that
the resident came to the nurse’s station complaining and asking that his urologist be called. She
testified that she did not examine him, because he wanted the urologist called right away. She
testified she called, but the urologist was out. LPN Coughlin testified that she spoke with the
nurse and gave the resident the phone, and he spoke with the nurse and explained his symptoms.
She testified that, after the resident spoke with the nurse, she and the resident went back to the
resident’s room, and she examined him and found nothing that was not normal. The resident did
not complain of pain. The physician’s nurse subsequently called back with an order for Detrol.
The resident had had bladder spasms before and indicated understanding when LPN Coughlin
explained to him that the nurse had said spasms could make him feel like he had leakage or
swelling. He had also used Detrol before. LPN Coughlin testified that her note dated March 6,
2008, correctly states the resident was up that morning propelling around the facility in his
wheelchair, laughing and talking with staff. She testified that about 7:00 a.m., while she was
passing medication, the resident asked if his Detrol was in. He did not complain of pain.
However, he said that he still felt pressure, and he thought maybe it was a spasm and wanted to
get started with the medication. LPN Coughlin testified that the resident would periodically
empty his catheter bag himself, so she had to ask him about his urine output. She testified that, at
about 10:45 a.m., she was called to the resident’s room where she found him sitting in his
wheelchair, and there was a lot of bright red blood in his catheter tubing. She asked him what
happened, and he said he was transferring from the toilet to his wheelchair when he felt
something pop. He denied that he had pulled on the catheter. She testified that she visualized the
scrotum, saw the area was very swollen, and immediately went to call for orders to send the
resident to the hospital. Tr. at 189-208. I find that LPN Coughlin’s testimony is generally
credible. Her testimony suggesting that Resident 14 normally used an in-out or straight catheter
to catheterize himself is inconsistent with the clinical record that shows he had a Foley catheter
the majority of his stay with Petitioner. Otherwise, her testimony is unrebutted, consistent with
the clinical record in evidence, and credible.

"2 | do not interpret this complaint to be that the Foley catheter had a 10 cc bulb, but that
whatever size the Foley bulb was, Resident 14 felt as if its inflated size was only about 10 cc.
12

Petitioner also presented the testimony of DON Sara Kilburn, RN. DON Kilburn testified that
she did not provide direct care to Resident 14 but that she investigated his case, including
reviewing his chart after Petitioner was cited by the survey. She described the process for placing
a Foley catheter and testified that, if the bulb were inflated in the urethra, there would be
resistance, it would cause immediate excruciating pain, and most likely there would be bleeding.
She testified that Resident 14 would report anything unusual to the nurses. She testified that
bladder spasms may cause a pain like a cramp, a feeling of fullness, or a stabbing pain. DON
Kilburn testified that the resident’s foot wound caused him pain, and he had an order for the pain
medication Hydrocodone, which he received when necessary. She testified that, when the
resident returned from his cystoscopy on March 3, 2008, he had instructions for monitoring which
would be for complaints of pain, bleeding, inability to urinate, or a fever. She opined that
monitoring of the resident was adequate though the documentation of the monitoring was
inadequate. Tr. at 220-42.

b. Analysis

The general quality of care regulation requires that each resident receive care and services
necessary to attain and maintain the highest practicable physical, mental, and psychosocial well-
being. The care and services that must be delivered are based upon the resident’s comprehensive
assessment and the requirements of the resident’s plan of care. 42 C.F.R. § 483.25.

The Statement of Deficiencies (SOD), Tag F309, focuses upon treatment and services during the
period following the March 3, 2008 cystoscopy and the resident’s transport to the emergency
room on March 6, 2008. The SOD alleges that Petitioner violated the regulation, because
Petitioner failed to ensure that necessary care and services were provided to Resident 14 to ensure
that he did not have complications from the cystoscopy or his Foley catheter. The SOD alleges
specifically that Petitioner failed to: (1) provide accurate, complete nursing assessments
ollowing Resident 14’s return to the facility on March 3, 2008 after the cystoscopy; (2) monitor
or complications following the cystoscopy; (3) monitor for complications after a urinary catheter
insertion after the cystoscopy; (4) consistently and accurately assess pain symptoms to determine
the cause, location, severity, and response to treatment; (5) ensure symptoms, including pain,
swelling, and decreased urine output, were identified as potential post-operative complications or
post-catheter insertion complications and were immediately reported to the physician; and (6)
ensure the correct size urinary catheter was inserted in accordance with the physician’s order.

The SOD alleges that the deficiency posed immediate jeopardy to Resident 14, as he suffered a
urethral perforation that resulted in a scrotal abscess and surgical removal of his testes. The SOD
alleges that the deficiency also had the potential for causing more than minimal harm to nine
other residents who had indwelling catheters. CMS Ex. 2, at 3-4; P. Ex. 1, at 3-4. CMS argued at
hearing that Petitioner violated 42 C.F.R. § 483.25, because staff failed to follow Resident 14’s
plan of care, the physician’s orders, and the post-operative discharge instructions. Tr. at 27.
CMS clarified at hearing that it does not allege that Petitioner actually caused or contributed to
Resident 14’s urethral tear. Tr. at 42, 250-53. Surveyor Corbin testified that she participated as
the team leader of the survey of Petitioner that concluded on April 4, 2008, and that she prepared
the citation of deficiency under Tag F309. Her testimony was consistent with the allegations and
summary of the evidence that she set forth in the SOD. Tr. at 46-126, 179-85. She testified, that

13
during Petitioner’s annual recertification survey, she focused on Resident 14 due to a complaint
that he had suffered trauma from a catheter inserted at the facility. Surveyor Corbin testified that
she could not substantiate this complaint that Resident 14. Tr. at 78-86. She testified that she
became aware that the resident suffered some gruesome injuries, but she could not determine the
cause using the facility and hospital documentation. Tr. at 86-87.

CMS called Dorothy Beckley Doughty, RN, to testify, and she was qualified as a nurse with
expertise in wound, ostomy, and incontinence care. Tr. at 126, 136. She testified that she was
concerned because Resident 14 was at high risk, and Petitioner’s staff failed to do an appropriate
assessment on his return from a urologic procedure. She testified that his spina bifida caused
persistent problems with urinary continence and retention of urine. She testified that he was at
high risk due to his spina bifida and related urologic problems as well as his history of urologic
procedures. She testified that, after Resident 14 returned to Petitioner following his cystoscopy,
she found no documentation of assessment of his ability to void or for bladder distention. She

testified that she was concerned,
inconsistent. She testified that s!
Resident 14’s complaint of pain

because the documentation of care was incomplete and
e was also concerned that staff did not respond appropriately to
and swelling. Tr. at 140-48. On cross-examination she admitted

that there was no evidence that the resident suffered a urethral tear during the cystoscopy. She
opined, however, that she believed a urethral tear occurred sometime on March 4 or 5 as that
would explain the scrotal swelling due to urine leaking into the scrotal sac. She agreed that a
nurse’s note on March 6 at 1:12 p.m. indicates no visible edema but subsequently indicates
marked swelling. She testified that the complaints of scrotal pain and swelling on March 5 were
inconsistent with a traumatic injury on March 6. Tr. at 148-54. I do not find RN Doughty’s
opinion regarding the occurrence of a urethral tear prior to March 6, 2008, to be entitled to any
weight. RN Doughty was not qualified to provide testimony in the area of urology, and CMS
stated for the record that it was not seeking to prove that Petitioner caused the urethral tear.
Further, RN Doughty’s testimony is inconsistent with the credible evidence that a urethral tear
would result in extreme pain and observable blood in the urine, which did not occur in this case
until March 6, 2008. Her opinion that staff did not respond appropriately to Resident 14’s
complaint of pain and swelling is based on less than all the evidence and is also not weighty. The
clinical record as clarified by the testimony of LPN Coughlin shows that the resident’s complaints
on March 4, 2008, were addressed by a call to the resident’s physician and the receipt of the
prescription Detrol to address the diagnosis of possible bladder spasms. The testimony of LPN
Coughlin also shows that she did a more complete assessment of the resident following the call to
the physician.

Petitioner called Charles Pound, MD, to testify, and he was found qualified to opine as an expert
in the area of urology. Dr. Pound described the procedure for performing a cystoscopy. He
testified that the post-operative instructions (P. Ex. 18) following the cystoscopy in the case of
Resident 14 were typical. He testified that it is most important to monitor that a person can
urinate after the cystoscopy, and, if not, it would be necessary to place a Foley catheter. Dr.
Pound testified that, after a cystoscopy, nursing staff should be checking for blood in the urine
and signs of infection, such as swelling and fever. He testified that it would be most common for
problems to develop within the first 24 or 36 hours following the procedure. A patient such as
Resident 14 should have received prophylactic antibiotics. Dr. Pound opined that it was possible

14
that Resident 14 injured his urethra, which caused leakage over a period of time into his scrotum
that led to his severe complications. However, he also testified that what the resident described as
a popping sensation on March 6, is consistent with the bulb of the catheter being pulled from the
bladder into the urethra, causing immediate bleeding and pain. Dr. Pound also testified that the
most common circumstance for the catheter to get pulled is during a patient transfer, such as
Resident 14 indicated he had just done when the popping occurred. He opined that the resident’s
complaints of a feeling of swelling on March 4 and 5 were consistent with him having spasms,
and, absent other clinical signs or symptoms, the order for Detrol was the usual mode of
treatment. Tr. at 247-75. Dr. Pound’s testimony is unrebutted, and his testimony is credible. I
find his opinion that the incident on March 6, 2008, most likely involved the bulb on the catheter
being pulled into the resident’s urethra causing extreme pain and bleeding to be credible and
consistent with the other evidence and opinions.

CMS determined not to proceed on a theory that Petitioner caused or contributed to the injury that
caused the hospitalization of Resident 14 on March 6, 2008. Tr. at 42, 250-53. The CMS
decision is consistent with the evidence before me, including the opinions of Dr. Diaz, Resident
14’s treating urologist, and Dr. Pound. Thus, the issue of whether or not Petitioner violated 42
C.F.R. § 483.25 (Tag F309) turns upon whether Petitioner provided necessary care and services
to avoid or address any complications following Resident 14’s return to Petitioner on March 3,
2008, following his cystoscopy. Resident 14’s injury on the morning of March 6, 2008, is not
evidence that Petitioner failed to deliver necessary care and services. The SOD alleges that
Petitioner failed to deliver necessary care and services after the cystoscopy on March 3, 2008 in
six specific ways. The SOD alleges specifically that Petitioner failed to: (1) provide accurate,
complete nursing assessments; (2) monitor for complications following a surgical procedure; (3)
monitor for complications after a urinary catheter insertion; (4) consistently and accurately assess
pain symptoms to determine the cause, location, severity and response to treatment; (5) ensure
symptoms including pain, swelling and decreased urine output were identified as potential post-
operative complications or post-catheter insertion complications and were immediately reported
to the physician; and (6) ensure the correct size urinary catheter was inserted in accordance with
the physician’s order. I consider each alleged basis and conclude that Petitioner did fail to deliver
necessary care and services to Resident 14.

Petitioner failed to ensure an accurate and complete nursing assessment was done when the
resident returned from a cystoscopy and failed to monitor for complications from the cystoscopy.
On March 3, 2008, Resident 14 underwent the cystoscopy. P. Ex. 18; Tr. at 263. Post-operative
instructions indicate that a small amount of blood in the urine would not be unusual and that the
physician should be notified if the amount of blood becomes excessive or there is difficulty
voiding. P. Ex. 18, at 2. Additional instructions following surgery were to observe the area for
signs of excessive bleeding and signs of infection, including: increased pain, redness, swelling,
and foul odor. Additionally, nursing personnel were to reinsert the Foley catheter if the resident
was unable to urinate. P. Ex. 18, at 1. Dr. Pound testified that the post-operative instructions (P.
Ex. 18) following the cystoscopy in the case of Resident 14 were typical. He testified that it is
most important to monitor that a person can urinate after the cystoscopy, and, if not, it would be
necessary to place a Foley catheter. He testified that after a cystoscopy, nursing staff should be
checking for blood in the urine and signs of infection, such as swelling and fever. Dr. Pound also

15
testified that it would be most common for problems to develop within the first 24 or 36 hours
following the procedure, emphasizing the importance of assessment of the resident during that
period. I conclude that the post-operative instructions and Dr. Pound’s testimony reflect the
standard of care that was to be delivered for Resident 14 following the cystoscopy and upon his
return to Petitioner’s facility. DON Kilburn also testified that appropriate monitoring upon return
from the cystoscopy would have included monitoring urination, for fever, and complaints of pain
or bleeding. Tr. at 237.

The time that Resident 14 returned to Petitioner’s facility on March 3, 2008, is not reflected in the
evidence before me. The only nurse’s note dated March 3, 2008 at 6:47 p.m. does not show that
staff assessed the resident’s ability to urinate, whether he had blood in his urine, or whether he
had any swelling or fever. P. Ex. 13, at 46. The clinical record shows that the resident received
Hydrocodone at 9:00 p.m., but the location of his pain is not indicated, and there is no
information that indicates an assessment was done. CMS Ex. 9, at 10. A nurse’s note dated
March 4, 2008 at 3:44 a.m. shows that the resident was assessed as resting quietly, with closed
eyes. His respirations were even and regular, his skin was warm and dry to touch, and no adverse
reaction to either Tamiflu or the administered antibiotic was noted. The resident reportedly
requested that a Foley catheter be placed, but the nurse did not do so because she did not have the
right size. The note does not show that staff assessed the resident’s ability to urinate other than
his request for a Foley, whether he had blood in his urine, or whether he had any swelling or
fever. P. Ex. 13, at 46. The two nurses who made the above-described notes did not appear and
testify at hearing to clarify or elaborate upon their notes. DON Kilburn testified that she did not
provide direct care for Resident 14, but she did review his clinical record. Tr. at 224. She opined
that monitoring of the resident after his return from the cystoscopy was adequate, as the nurses
were able to answer all her questions about whether he had blood in his urine and whether there
was urine return when the catheter was placed. Tr. at 238. DON Kilburn’s opinion is not
credible to the extent that it was intended to include the afternoon and evening of March 3 and
early morning of March 4, 2008. DON Kilburn did not testify that she interviewed the two nurses
who wrote the nurse’s notes during that period. Further, the evidence shows that LPN Coughlin
placed the Foley later during the morning of March 4, 2008, after her arrival at work around 5:45
a.m. Based on these facts, I conclude that Petitioner has not shown that necessary care and
services were delivered to Resident 14 after his return from the cystoscopy on March 3 and prior
to 5:45 a.m. on March 4, as Petitioner has failed to show that Resident 14 received the necessary
assessment and monitoring.

However, the documentary evidence and the testimony of LPN Coughlin is sufficient to show
that, after she arrived at work at approximately 5:45 a.m. on March 4, 2008, the resident was
appropriately assessed when the Foley catheter was placed. The evidence shows further adequate
assessment on March 5, 2008, when the resident complained that he felt as if he had some
swelling in his groin.

CMS alleges that Petitioner failed to monitor for complications after a urinary catheter insertion.
I find this allegation unfounded. The evidence shows that, during the morning of March 4, 2008,
LPN Coughlin inserted a Foley catheter. Nurse’s notes reflect that the catheter was consistently

monitored on March 4, 5, and 6, with an adjustment of position required on March 5, 2008.

16
When the resident complained of discomfort on March 5, 2008, his physician was contacted, and
a new order was received. On March 6, 2008, Resident 14 was assessed, and, when he
subsequently developed new symptoms, his physician was consulted and he was sent to the
emergency room. P. Ex. 13, at 47. LPN Coughlin’s and DON Kilburn’s testimony is credible to
the extent it is consistent with the nurse’s notes. Their testimony provides some clarification of
the notes.

CMS alleges that Petitioner’s staff failed to consistently and accurately assess pain symptoms to
determine the cause, location, severity, and response to treatment. I agree that Petitioner’s staff
failed to adequately document pain assessments and the reason for administering pain medication.
The parties do not dispute that the standard of care or practice with respect to pain assessment is
to assess pain, including attempting to determine cause, location, severity, and response to
treatment. The evidence shows that the resident received Hydrocodone at 9:00 p.m. on March 3
(I infer this was after his return from the cystoscopy), but the location of his pain is not indicated.
CMS Ex. 9, at 10. The evidence shows that Resident 14 was given Hydrocodone at 6:00 a.m. and
10:00 a.m. on March 4, 2008, and the 6:00 a.m. dose was for a complaint of bladder pain.'> CMS
Ex. 9, at 8, 10. He received another Hydrocodone for a complaint of scrotal pain around 8:00
a.m. on March 5, 2008. He rated the pain as four, which is mild pain on Petitioner’s scale. At
9:10 a.m., the resident rated the pain as two, which is still mild pain. Resident 14 wanted his
physician called. CMS Ex. 9, at 9, 10. He was given another Hydrocodone at 1:00 p.m. on
March 5, 2008. CMS Ex. 9, at 10. The evidence also does not show why Resident 14 was given
a Hydrocodone at 6:30 a.m. on March 6, 2008, whether for a compliant of bladder pain or foot
pain. CMS Ex. 9, at 10. The administration of the drug at 6:00 a.m. on March 4 was noted to be
for bladder pain but there is no notation of the cause, severity, or response to the drug. The
administration of Hydrocodone at 8:00 a.m. on March 5, 2008, was accompanied by an
assessment of the location of the pain, the severity of the pain, and the response to the medication.
However, the cause of the pain is not addressed for that instance. I have no evidence,
documentary or testimonial, that assessments were done with the other administrations of
Hydrocodone between Resident 14’s return from the cystoscopy and his departure for the
emergency room.

CMS alleges that Petitioner’s staff failed to ensure symptoms, including pain, swelling, and
decreased urine output, were identified as potential post-operative complications or post-catheter
insertion complications and were immediately reported to the physician. The evidence does not
tell me when Resident 14 returned to Petitioner’s facility on March 3, 2008, following his
cystoscopy. The only nurse’s note dated March 3, 2008 at 6:47 p.m. does not show that staff
assessed the resident’s ability to urinate, whether he had blood in his urine, or whether he had any

13

I have no physician’s order in evidence prescribing Hydrocodone for bladder pain. DON
Kilburn testified consistent with my interpretation of the evidence that Hydrocodone was for the
resident’s foot pain, not bladder pain. Tr. at 234-35; P. Ex. 16. CMS does not allege that
Petitioner committed any regulatory violation in this regard, and I find none.
17
swelling or fever. However, no complaints of pain, swelling, or decreased urine output are noted.
P. Ex. 13, at 46. The clinical record shows that the resident received Hydrocodone at 9:00 p.m.
for pain, but the location of his pain is not indicated. CMS Ex. 9, at 10. A nurse’s note dated
March 4, 2008 at 3:44 a.m. shows that the resident was assessed as resting quietly, with closed
eyes, his respirations were even and regular, his skin was warm and dry to touch, and no adverse
reaction to either Tamiflu or the administered antibiotic was noted. The resident reportedly
requested that a Foley catheter be placed but the nurse did not do so, because she did not have the
right size. The note does not reflect any pain, swelling, or evidence of decreased urine output. P.
Ex. 13, at 46. Resident 14 was given Hydrocodone at 6:00 a.m. and 10:00 a.m. on March 4,
2008, and the 6:00 a.m. dose was for a complaint of bladder pain. CMS Ex. 9, at 8, 10. Resident
14 received another Hydrocodone for a complaint of scrotal pain around 8:00 a.m. on March 5,
2008. CMS Ex. 9, at 9, 10. When Resident 14 complained to LPN Coughlin on March 5, 2008,
that he felt as if he had swelling in his groin, the physician was consulted, and a new order was
received. P. Ex. 13, at 47. According to LPN Coughlin’s testimony, she did an assessment of the
resident at the time and found no signs or symptoms of complications. The evidence does not
show that the fact the resident was given Hydrocodone for scrotal pain was reported to the
physician, even though increased pain was one of the signs and symptoms staff was to monitor
that was listed among the additional instructions following the cystoscopy. P. Ex. 18, at 1.
Although LPN Coughlin did consult with the physician regarding the resident’s complaint of
swelling, the evidence does not show the physician was consulted regarding the resident’s
repeated complaints of pain for which he was given Hydrocodone.

CMS also alleges that Petitioner violated the regulation, because Petitioner failed to ensure the
correct size urinary catheter was inserted in accordance with the physician’s order. The last
physician order related to Foley catheter size in the evidence before me is the order of February
22, 2008, which required an 18 French Foley catheter with a 30 cc bulb. P. Exs. 16, at 3; 21, at 3.
The nurse’s note dated March 4, 2008 at 3:44 a.m. shows that LPN Hewitt could not insert a
Foley catheter for Resident 14 as he requested, because she had no Foley available in the correct
size. P. Ex. 13, at 46. The evidence does show that a Foley was inserted around 5:45 a.m. on
March 4, 2008, but the size is not reflected in LPN Coughlin’s nurse’s note (P. Ex. 13, at 47), and
she did not specify the size of the Foley in her testimony. Petitioner has not presented any
competent evidence to overcome the inference triggered by its clinical record that a Foley of an
incorrect size was inserted around 5:45 a.m. on March 4, 2008.

I conclude that Petitioner failed to deliver necessary care and services to Resident 14 on March 3
to 6, 2008, a violation of 42 C.F.R. § 483.25. Therefore, the issue is whether or not the violation
amounted to substantial noncompliance, i.e., whether it posed a risk for more than minimal harm
to Resident 14 or any other resident. The surveyors alleged in the SOD that there was immediate
jeopardy, because Resident 14 suffered a urethral perforation that resulted in a scrotal abscess and

18
surgical removal of his testes.'* P. Ex. 1, at 3-4. However, CMS does not advance that theory
before me. CMS correctly states that 42 C.F.R. § 498.60(c)(2) provides that the CMS
determination of the level of noncompliance must be upheld, unless it is clearly erroneous. CMS
Post-Hearing Brief (CMS Br.) at 3. CMS also correctly states that prior decisions of the Board
have found it appropriate to require CMS to make a prima facie showing that a facility is not in
substantial compliance with program participation requirements. CMS Br. at 4. To make a prima
facie showing that a facility is not in substantial compliance, CMS must show not only that a
facility violated a statutory or regulatory participation requirement but also that the violation had
the potential to cause more than minimal harm to one or more residents. 42 C.F.R. § 488.301.
CMS argues that it has presented evidence from which one could reasonably conclude that there
was immediate jeopardy. CMS Br. at 24. But CMS conceded at hearing that it does not proceed
upon a theory that Petitioner caused Resident 14’s urethral tear. CMS points to the speculation of
its expert that the urethral tear could have occurred during the cystoscopy or when the resident
attempted to self-catheterize on March 3. CMS Br. at 20. But I find that speculation not credible
given the expert’s lack of credentials in urology and the fact that a urethral tear at those times is
obviously inconsistent with the credible and weighty testimony that such a tear would cause
extreme pain and observable blood in the urine, neither of which was present on March 3, 2008.
CMS asserts that the various failings of Petitioner posed immediate jeopardy, but CMS fails to
point to any credible evidence that any of the failures of Petitioner posed a risk for serious injury,
harm, impairment, or death. CMS Br. at 25-28. CMS’s assertions are no substitute for competent
evidence, and CMS’s assertions are an inadequate basis to find immediate jeopardy. I conclude
that the determination of immediate jeopardy was clearly erroneous. However, I also conclude
that the evidence shows that Resident 14 and the other nine residents with indwelling catheters
were at risk for more than minimal harm as alleged by the surveyors in the SOD. P. Ex. 1, at 4.
The evidence does not support a conclusion that Resident 14 was subject to serious injury, harm,
impairment, or death based upon the specific violations that I have found. The evidence shows
that Resident 14 did receive medication for pain. The evidence also shows that Resident 14 did
receive a Foley catheter after a delay of a couple hours. While Resident 14 may have experienced

'* Petitioner argues that CMS is bound by the recommendation of the informal dispute resolution
(IDR) process that the scope and severity finding of the surveyors should be reduced from
immediate jeopardy to a potential for more than minimal harm. Petitioner’s Post-Hearing Brief
(P. Br.) at 4, 25-27; P. Ex. 4. CMS argues that the state never adopted the recommendation of the
impartial decision-maker, and CMS had no reason to specifically reject the decision. Immediate
jeopardy is not an issue because the amount of the PICMP is not affected by the immediate
jeopardy determination, and Petitioner has no right to review of a scope and severity
determination when a PICMP has been imposed. CMS Reply Brief (CMS Reply). Petitioner’s
argument is mooted by my decision. I agree with CMS that Petitioner is not entitled to review of
a scope and severity determination in this case. However, it is necessary to determine whether
there was a potential for more than minimal harm to determine whether or not Petitioner was in
substantial compliance with program participation requirements. It is also necessary for me to
make a determination as to the severity of any deficiency for purposes of fulfilling my regulatory
duty to make a de novo determination of the reasonableness of the proposed enforcement remedy.

19
discomfort while waiting for his pain medication to take effect or for his Foley to be inserted to
relieve his bladder, I do not conclude that the discomfort amounted to actual harm. However, I do
conclude, based upon the surveyor’s opinion as expressed in the SOD, that the failure to properly
assess a resident following return from a procedure, such as a cystoscopy, and to monitor for
signs and symptoms of complications poses the risk for more than minimal harm due to the
potential for complications, such as excessive bleeding or infection related to such a procedure.

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.25, and the violation posed a risk
for more than minimal harm to Resident 14 and nine other similarly situated residents.

3. There is a basis for the imposition of an enforcement remedy.
4. A $6,000 PICMP is not reasonable in this case.
5. A $3,000 PICMP is reasonable in this case.

I have concluded that Petitioner violated 42 C.F.R. § 483.25 and that the violation posed a risk for
more than minimal harm to one or more facility residents. Ifa facility is not in substantial
compliance with program requirements, CMS has the authority to impose one or more of the
enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP. CMS may impose a per
day CMP for the number of days that the facility is not in compliance or a PICMP for each
instance that a facility is not in substantial compliance, whether or not the deficiencies pose
immediate jeopardy. 42 C.F.R. § 488.430(a). The minimum amount for a PICMP is $1,000 and
the maximum is $10,000. 42 C.F.R. § 488.438(a)(2). I conclude that there is a basis to impose a
PICMP in this case.

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

20
is de novo and based upon the evidence in the record before me. I am not bound to defer to the
CMS determination of the amount of the CMP to impose, but my authority is limited by
regulation as already explained. I am to determine whether the amount of any CMP proposed is
within reasonable bounds considering the purpose of the Act and regulations. Emerald Oaks,
DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol
Hill Community Rehab. and Specialty Care Ctr., DAB No. 1629 (1997).

I have received no evidence that Petitioner had a history of noncompliance. I have also received
no evidence that Petitioner is unable to pay a PICMP. I do conclude that Petitioner’s violation
was serious and that Petitioner was culpable for disregarding the post-operative instructions of
Resident 14 for several hours after his return to the facility on March 3, 2008. The evidence
shows that Petitioner’s deficiency posed a risk for more than minimal harm to Resident 14 and
other residents. However, as already discussed, I do not find that Resident 14 or any other
resident suffered actual harm due to the deficiency. I also do not find, based on evidence before
me, that there was a risk for serious injury, harm, impairment, or the death of a resident due to the
deficiency. I further conclude that the evidence shows only one deficiency based upon the case of
Resident 14, and, therefore, it was an isolated occurrence. The state agency and CMS selected to
impose a CMP, a decision I have no authority to review. However, the reasonableness of the
amount of the CMP must be reviewed. The state agency and CMS determined that $6,000 was a
reasonable PICMP. However, pursuant to 42 C.F.R. § 488.404(b), CMS and the state were
required to consider that the deficiency posed immediate jeopardy, the severity determination at
the time. Upon my review, I have found that there was no immediate jeopardy or actual harm. I
conclude in this case, in the absence of actual harm or immediate jeopardy, that a $6,000 PICMP
is not reasonable based upon the evidence before me. Rather, considering the purpose for
imposing enforcement remedies under the Act and regulations, I conclude that a PICMP of
$3,000 is sufficient to encourage Petitioner’s prompt return to substantial compliance. '*

6. The burden of persuasion does not affect the outcome of this case.

7. Review of the reasonableness of the proposed enforcement remedy was de
novo and review of how CMS considered the regulatory factors when
proposing an enforcement remedy is not relevant to my review.

Petitioner attempts to preserve two additional issues for appeal in its June 17, 2008 request for
hearing. Petitioner argues that the allocation of the burden of persuasion in this case according to
the rationale of the Board in the prior decisions cited above violates the Administrative
Procedures Act, 5 U.S.C. § 551 et. seq., specifically 5 U.S.C.

'S Petitioner briefly discusses the CMS “Five Star Quality Rating System.” Petitioner’s Post-
Hearing Reply at 19. Petitioner does not argue that I have jurisdiction to review CMS decisions
under that system. Rather, it appears that Petitioner is simply attempting to preserve an issue for
any subsequent appeal.
21
§ 556(d). P. Br. at 15-17. Because the evidence is not in equipoise, the burden of persuasion did
not affect my decision, and Petitioner suffered no prejudice.

Petitioner also argues that the Medicare Act is violated, and Petitioner is deprived of due process
if CMS is not required to submit evidence to prove it considered the regulatory criteria
established by 42 C.F.R. §§ 488.404 and 488.438(f). Petitioner’s Hearing Request. As discussed
above, my review of the reasonableness of the enforcement remedy is a de novo review of the
evidence related to the regulatory factors. I am not permitted and have no authority to review the
choice of a PICMP, and I have no need to consider whether CMS properly evaluated the
regulatory factors. Petitioner does not clearly state what prejudice it may have suffered, and I
perceive none.

Il. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. § 483.25 and that a
PICMP of $3,000 is reasonable.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Kenneth Schrager
(OI File No.: 2-00-40651-9),

Petitioner
Vv.
The Inspector General.
Docket No. C-10-738
Decision No. CR2279

Date: November 9, 2010

DECISION

Petitioner, Kenneth Schrager, asks review of the Inspector General’s (I.G.’s) May 31,
2001 determination to exclude him, for a minimum period of twenty years, from
participation in the Medicare, Medicaid, and all federal health care programs, as provided
for in section 1128(a)(1) of the Social Security Act. The I.G. has moved to dismiss,
arguing that the appeal is untimely. I agree and dismiss Petitioner’s appeal.

Petitioner’s hearing request must be dismissed pursuant to
42 C.F.R. § 1005.2(e)(1), because it was not timely filed.’

Procedural history. In a letter dated May 31, 2001, the I.G. advised Petitioner that, based
on his conviction “of a criminal offense related to the delivery of an item or service under
the Medicare program,” he was excluded from participation in Medicare, Medicaid, and
all federal health care programs for a period of twenty years. I.G. Ex. 1. With the notice
letter, the I.G. sent Petitioner an explanation of his appeal rights: he was entitled to a
hearing before an administrative law judge (ALJ) if he filed a written request for review

' [make this one finding of fact/conclusion of law.
within sixty days after receipt of the notice. LG. Ex. 1, at 3. Petitioner filed his hearing
request nine years later, on May 27, 2010 (received in the Civil Remedies Division on
June 1, 2010).”

The appeal was initially assigned to ALJ Alfonso J. Montano, who held a prehearing
conference, at which the parties agreed to address initially the threshold issue of the
appeal’s timeliness. Judge Montano then set a briefing schedule. When Judge Montano
left the Civil Remedies Division, the matter was reassigned to me.

The I.G. filed his motion to dismiss (1.G. Br.), accompanied by four exhibits (I.G. Exs. 1-
4), and Petitioner filed a response (P. Br.) with seven exhibits (P. Exs. 1-7). The LG.
filed a reply brief (I.G. Reply) with two additional exhibits (I.G. Exs. 5-6). Petitioner
then filed a sur-reply (P. Sur-reply), and the LG. filed a response to the sur-reply (LG.
Response) with two additional exhibits (I.G. Exs. 7-8).

Discussion. An aggrieved party must request a hearing within sixty days after receiving
notice of the exclusion. 42 C.F.R. § 1001.2007(b). The date of receipt is presumed to be
five days after the date of the notice, unless there is a reasonable showing to the contrary.
42 C.F.R. § 1005.2(c). The regulations include no good-cause exceptions for untimely
filing, providing that the ALJ wil/ dismiss a hearing request that is not filed in a timely
manner. 42 C.F.R. § 1005.2(e)(1); John Maiorano, R. Ph., v. Thompson, Civil Action
No. 04-2279, 2008 WL 304899, at *6 (D. N.J. 2008).

Petitioner has admitted that he knew he would be excluded — his attorneys told him so —
but claims that he thought that the exclusion would be for five years rather than twenty.
P. Ex. 5 at 1. He does not dispute that, consistent with its policy and practice, the I.G.
mailed notice of the twenty-year exclusion to him on May 31, 2001. The I.G. sent the
notice to the Federal Correctional Institution (FCI) in Otisville, New York, where
Petitioner was incarcerated. I.G. Ex. 3, at 2 (Byer Decl. §§ 4, 7). So, based on the
regulatory presumption, we assume that Petitioner received it on June 5, 2001. Since the
sixtieth day thereafter fell on a Saturday, his hearing request was due on or before August
6, 2001. 42 C.F.R. § 1005.12(a). But he did not file his request until May 27, 20/0, nine
years after the date of the notice.

Petitioner, however, denies receiving the notice and claims that he first learned of his
exclusion in March 2010, after his medical license was reinstated. He then contacted the
1.G., who responded on April 9, 2010, sending him a copy of the notice letter.

> Prior to filing his hearing request, Petitioner sent the I.G. a letter, dated March 29, 2010,
asking him to reconsider the exclusion. P. Ex. 5. If timely, the document would likely
have been sufficient to preserve his appeal rights, but, obviously, it too was submitted
well after the filing deadline had passed.
By themselves, such assertions of non-receipt are insufficient to overcome the regulatory
presumption. To rebut that presumption, Petitioner must make a “reasonable showing”
that he did not receive the notice. Gary Grossman, DAB No. 2267 at 5-6 (2009). Here,
Petitioner initially claimed that he did not receive the notice because he was residing in a
alf-way house at the time the I.G. mailed it to his former prison residence. According to
Petitioner, the prison did not forward his mail. P. Ex. 5, at 1. In fact, the record
establishes that Petitioner resided at the Federal Correctional Institution (FCI) — Otisville
rom December 4, 2000 until September 4, 2001. He did not transfer to a half-way house
until September 4, 2001. 1.G. Ex. 4. After reviewing an affidavit from Arthur
Buchanan, Correctional Systems Officer in Otisville’s Inmate Records Department (I.G.
Ex. 4), Petitioner conceded that he was still in the Otisville prison when the L.G. sent his
notice letter there. P. Ex. 7, at 2-3 (Schrager Decl. § 11).

Petitioner nevertheless cites, as sufficient to establish the requisite “reasonable showing,”
two additional issues surrounding delivery of the notice.* First, although he concedes
that the letter was correctly sent to “FCI Otisville” and included Petitioner’s inmate
register number, he complains that the I.G. addressed it to “P.O. Box 600” — the delivery
address for staff mail — rather than “P.O. Box 1000” — the delivery address for inmate
mail. P. Ex. 1; P. Ex. 2, at 4; P. Ex. 3. Second, Petitioner claims that inmates, whom he
describes as “inherently unreliable,” were charged with the actual mail delivery.

I consider the minor address error insufficient to establish a reasonable showing of non-
delivery. According to Officer Buchanan, any inmate mail addressed to “P.O. Box 600”
would have been forwarded to the inmate, so long as the inmate was properly identified.
If the inmate were not properly identified, the mail would have been returned to the
sender. I.G. Ex. 6, at 2 (Buchanan Decl. §f 8, 9). Maureen R. Byer, Director of the
Exclusions Staff for the I.G.’s Office of Investigations, confirms that the notice was not
returned to the I.G. I.G. Ex. 3, at 2 (Byer Decl. § 7).

Petitioner’s complaints about the inherent unreliability of prison mail delivery also fail to
overcome the presumption of receipt. First, Petitioner’s position effectively turns on its
head the presumption of timely receipt, when applied to prison inmates, asking that I
presume non-delivery based on a prison’s internal systems for mail delivery. I am
unwilling to carve out such an exception to the regulation. Moreover, Petitioner’s

> Petitioner points to the evidentiary standards for summary judgment, and argues that I
should make no credibility determinations here and should draw all factual inferences in
his favor. Because a motion to dismiss is before me, I am not deciding the merits of this
case; instead, I am deciding whether Petitioner timely perfected his hearing rights.
Summary judgment standards therefore do not apply. Grossman, DAB 2267 at 6-7. In
any event, as the above discussion shows, Petitioner has not presented evidence sufficient
to establish a dispute over a material fact, so he would fail even under summary judgment
standards. See Illinois Knights Templar, DAB No. 2274 at 3-4 (2009).
assertion is not supported. According to the prison’s orientation materials, incoming mail
is delivered to the inmate population within twenty-four hours of receipt. P. Ex. 2, at 4.
Officer Buchanan explains the mail delivery system at Otisville — staff, not inmates: sort
the incoming mail; inspect it as necessary; transport it to the appropriate housing units;
and deliver it directly to the addressee. IG. Ex. 7, at 2 (Buchanan Decl. {ff 8, 9, 10).

Thus, Petitioner has not made a “reasonable showing” of non-delivery. I therefore have
no discretion and must dismiss his hearing request pursuant to 42 C.F.R. § 1005.2(e)(1).

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Paul R. Clark d/b/a Clark Orthopedics Company,
(PTAN: 0561800001),

Petitioner,
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-10-686
Decision No. CR2276

Date: October 27, 2010

DECISION DISMISSING REQUEST FOR HEARING
WITHOUT PREJUDICE

By letter dated April 30, 2010, Petitioner requested an ALJ hearing on the Medicare
contractor’s revocation of Petitioner’s durable medical equipment, prosthetics, orthotics
and supplies (DMEPOS) Medicare billing privileges and two-year bar on reenrollment as
a supplier. On May 12, 2010, I acknowledged receipt of Petitioner’s request and set up a
briefing schedule. In that Order, I emphasized that time is of the essence in this case.
See 42 C.F.R. § 498.79.

Subsequent communications from the parties indicated that the Centers for Medicare and
Medicaid Services (CMS) and the Medicare contractor were working with Petitioner to
waive the reenrollment bar and reinstate Petitioner upon filing of a reenrollment
application. In order to accommodate these efforts, I issued additional rulings providing
time for the parties to come to a resolution. See Order Granting Extension dated June 21,
2010; Ruling On Motion To Dismiss and Order Setting Further Proceedings dated July
22, 2010. CMS complied with my Order to file its exchange and Petitioner was directed
to file his exchange by August 26, 2010 but did not do so. On September 2, 2010, I
therefore issued an Order to Show Cause within 10 days as to why I should not dismiss
the request for abandonment. On September 13, 2010, Petitioner requested an extension
of time which | again granted, allowing Petitioner until September 30, 2010 to show
cause.

The parties then indicated that the contractor was processing Petitioner’s application but
had yet to make a final determination. On October 6, 2010, I stayed this case for two
weeks to allow the contractor to process Petitioner’s application. Finally, on October 20,
2010, I notified the parties that unless I heard good cause why I should not close this
case, I would dismiss without prejudice the following week.

CMS did not object to dismissal without prejudice. In an October 22, 2010 email
communication with my office, however, Petitioner stated that he preferred to keep his
appeal “still active and extended until a decision is made by the contractor.”

This case has languished for a significant period of time without active development.
The delays are not all attributable to one party and have, in the end, resulted in an agreed
process to resolve the dispute. I encourage the parties to continue with the agreed
reinstatement process, but I do not see that a purpose is served by maintaining
indefinitely on the docket an appeal that is not being actively pursued. I understand
Petitioner’s concerns that his position not be prejudiced in the event that the
reinstatement process breaks down or results in an unfavorable outcome. I conclude,
however, that those concerns can be effectively met by issuing this dismissal without
prejudice.

I am authorized to dismiss a request for a hearing that has been abandoned. I may
consider a request for hearing to be abandoned if the party requesting a hearing fails to
respond within 10 days to a “show cause” notice with a showing of good cause. 42
C.F.R. § 498.69(b)(2). Iam unable to find good cause to keep this appeal open at this
time when Petitioner is not seeking to go forward and develop the record for a final
decision.

I emphasize that I am dismissing this case without prejudice. The effect of a dismissal
without prejudice is that Petitioner may file to reopen the appeal at any time if the result
of the current reinstatement process is adverse. Therefore, if Petitioner’s reenrollment
application is denied, he can refile his request for an ALJ hearing. I may also vacate a
dismissal if either party so requests within 60 days after receipt of the dismissal and
shows good cause for vacating it. 42 C.F.R. § 498.72.

/s/
Leslie A. Sussan
Board Member


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Silverbrook Manor,
(CCN: 23-5361),
Petitioner,
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-10-706
Decision No. CR2275
Date: October 27, 2010
DECISION
l enter summary judgment against Petitioner, Silverbrook Manor, and in favor of the
Centers for Medicare and Medicaid Services (CMS) sustaining the following remedies:
¢ Acivil money penalty of $4,550 for one day, October 29, 2009;

¢ Civil money penalties of $600 per day for each day of a period beginning on
October 30, 2009 and running through December 21, 2009; and

e Denial of payment for new Medicare admissions for each day of a period
beginning on December 6, 2009 and running through December 21, 2009.

I. Background

Petitioner is a skilled nursing facility in the State of Michigan. It participates in the
Medicare program and its participation in Medicare is governed by sections 1819 and
1866 of the Social Security Act (Act) as well as by implementing regulations at 42 C.F.R.
Parts 483 and 488. Its hearing rights in this case are governed by regulations at 42 C.F.R.
Part 498.

Petitioner filed hearing requests to challenge the remedy determinations that I describe in
the opening paragraph of this decision. The case was assigned originally to another
administrative law judge who consolidated the requests into one case. The case was
reassigned to me after his departure from the Departmental Appeals Board.

CMS moved for summary judgment and Petitioner opposed the motion. I advised the
parties that the motion and opposition had raised an issue that neither of them had fully
briefed and I directed them to file supplemental briefs. The parties complied.

CMS filed a total of 56 proposed exhibits with its motion for summary judgment which it
identified as CMS Ex. 1 —- CMS Ex. 56. Petitioner filed a single exhibit in opposition to
the motion which it identified as P. Ex. 1. I receive these exhibits into the record.

IL. Issue, findings of fact and conclusions of law
A. Issue

The sole issue before me is whether CMS was, as a matter of law, authorized to continue
imposing civil money penalties of $600 per day and denial of payment for new Medicare
admissions against Petitioner for each day of the period beginning on November 25 2009
and continuing through December 21, 2009.

CMS based its determination to impose remedies against Petitioner on noncompliance
findings that were made at a complaint survey of Petitioner’s facility conducted on
November 5, 2009 (November Survey). Among the findings of noncompliance are three
on which CMS now bases its motion for summary judgment. These are findings that
Petitioner failed to comply substantially with the requirements of: 42 C.F.R.

§§ 483.25(h)(2); 483.25; and 483.20(k)(3)(i). The finding of noncompliance with 42
C.F.R. § 483.25(h)(2) included a determination that Petitioner’s noncompliance with that
regulation was so egregious as to constitute immediate jeopardy for Petitioner’s residents.
“Immediate jeopardy” is defined to mean noncompliance that causes, or is likely to
cause, serious injury, harm, impairment, or death to a resident or residents. 42 C.F.R.

§ 488.301.

Petitioner did not deny its noncompliance with any of these regulations nor did it contest
CMS’s finding of immediate jeopardy level noncompliance. Furthermore, Petitioner did
not challenge the reasonableness of the penalty amount determinations that I discuss at
the beginning of this decision. Instead, Petitioner argues that it attained compliance with
all participation requirements on November 25, 2009. It asserts that the remedies that
CMS determined to impose on or after that date are unauthorized. Thus, Petitioner
contends that no civil money penalties or denial of payment for new admissions may be
imposed against it beginning with November 25, 2009. Implicitly, Petitioner concedes
that the remedies imposed by CMS beginning on October 29, 2009 and continuing
through November 24, 2009 are authorized and reasonable.

B. Findings of fact and conclusions of law

I find that CMS was, as a matter of law, entitled to continue imposing against Petitioner
civil money penalties of $600 per day and denial of payment for new Medicare
admissions on each day of the November 25 — December 21, 2009 period.

Petitioner’s argument against continuation of remedies for the November 25 — December
21 period is that CMS’s determination of the duration of its noncompliance is incorrect.
It asserts that it attained compliance with participation requirements as of November 24,
2009 and that, consequently, CMS was not authorized to impose any remedies against it
after that date. In opposing CMS’s motion for summary judgment, it asserts that at the
least, there are disputed issues of fact concerning the date when it finally attained
compliance and that it is entitled to a hearing on the merits in order to be allowed to show
that it attained compliance on November 24, 2009.

The general rule governing duration of noncompliance is set forth at 42 C.F.R.
§ 488.454(a)(1). The regulation states that, where noncompliance is determined, a
remedy will remain in effect until:

The facility has achieved substantial compliance, as determined by CMS or
the State based on a revisit or after an examination of credible written
evidence that it can verify without an on-site visit... .

Id.; see 42 C.F.R. § 488.440(h)(1) (governing duration of civil money penalties); 42
C.F.R. § 488.417(d) (governing duration of denials of payment for new admissions).

The regulations make no explicit distinction between the circumstance in which
compliance may be verified solely based on documentary evidence and that which
requires an on-site visit in order to ascertain whether compliance has been attained. That
guidance is provided in the preamble to the Part 488 regulations:

There are other cases in which documentation cannot confirm the
correction of noncompliance, and in these cases an on-site revisit is
necessary. For example, one of the requirements for Infection Control is
that personnel must handle, store, process and transport linens so as to
prevent the spread of infection as specified in § 483.65. Ifa deficiency is
cited for a violation of this requirement and a civil monetary penalty is
imposed, submitting written documentation would not confirm the
correction of the violation. An on-site revisit to observe personnel behavior
is necessary in this case to confirm that the facility is, in fact, back in
substantial compliance with this regulatory provision.

59 Fed. Reg. 56116, 56207 (Nov. 10, 1994).

The distinction identified by the preamble is clear. Deficiencies that involve the actual
provision of care by facility staff may not be certified as having been corrected without
observation of personnel providing care. That is because the hands on provision of care
is an integral element of compliance. Thus, in the example cited — the handling, storing,
processing and transport of linens in a way intended to avoid the spread of pathogens — it
is not enough to attain compliance for a facility to provide documents which describe
corrective action measures. Rather, the surveyors must personally observe the staff
performing the necessary functions because staff performance in compliance with
applicable standards of care cannot be demonstrated solely with documentary evidence.

This is not to say that a facility may never establish compliance based on documentary
evidence of its efforts to correct a deficiency. There are some types of deficiencies for
which documentary evidence will suffice as proof of rectification. For example, a facility
may be found noncompliant with a Life Safety Code requirement because a particular
piece of equipment, such as a boiler or a water heater, is broken. In that circumstance
documents proving that repairs had been made to the equipment, that it had been tested,
and that it was now functional, would be sufficient evidence to prove that the facility had
attained compliance.

But, a wholly different situation presents where the deficiency involves a failure by staff
to provide care that is consistent with regulatory requirements. In that circumstance it is
human performance and not equipment that is the critical element of compliance. The
regulation, as interpreted by its preamble, requires observation of staff performance to
certify compliance in that circumstance.

Petitioner argues, correctly, that there is a series of decisions by the Departmental
Appeals Board which hold that a facility may attempt to prove that it corrected its
deficiencies at a date that is earlier than that which CMS certified compliance to have
been attained. But this general principal does not suggest that a facility may successfully
demonstrate compliance based on documentary evidence in those situations where
observation by surveyors is the only acceptable means by which compliance may be
established. Documentary evidence may be sufficient to prove compliance in the
instance where a failure of human performance is not a basis for the deficiency finding.
But, documentary evidence is on its face inadequate in the case where a failure of human
performance is the basis for the deficiency finding. None of the decisions relied on by
Petitioner is inconsistent with this distinction.
The three deficiencies that are at issue here all share the common feature that they
involve human performance and, for that reason, compliance may not be demonstrated
solely with documentary evidence. In the case of each of these deficiencies it was
necessary to observe the staff in order to assure that the staff was doing that which was
required of them. I find that, as a matter of law, documents showing that the staff had
been retrained and that systems had been put in place that are intended to monitor and
check on staff performance are inadequate to establish compliance. Thus, and as a matter
of law, the earliest date when any of these deficiencies could have been certified to have
been corrected was the date of the revisit survey — December 22, 2009 in this case — at
which the surveyors were assured that the staff were correctly discharging their
responsibilities.

Petitioner’s noncompliance with the requirements of 42 C.F.R. § 483.25(h)(2) relates to
the failure of Petitioner’s staff to provide appropriate supervision and assistance to
residents who were prone to eloping the facility. Petitioner relied on a system of alarms
connected to doorways to assure that residents who were prone to eloping did not exit the
acility unnoticed. However, there was more than one instance of elopement in which the
alarms did not function as intended. That reflected an overall failure on the part of
Petitioner and its staff to assure that the alarms were in working order.

The findings of noncompliance relate in large measure to the care that Petitioner gave to
a resident who is identified as R-100. This was a resident who had been identified by
Petitioner’s staff as having numerous physical and mental impairments including
delusional behavior. She wandered constantly and was a very high risk for eloping
Petitioner’s facility. In August 2009, the resident had 24 episodes of exit-seeking
behavior. Prior to September 6, 2009, the resident had eloped the facility three times.
CMS Ex. 29 at 12. On September 5, 2009, the resident was observed exiting the facility
through a door with a non-functioning alarm. CMS Ex. 28 at 3. On September 6, 2009,
the resident eloped the facility again, and was found walking down a neighbor’s
driveway. Jd.; CMS Ex. 30 at 20. As with a previous elopement the resident exited
through a doorway that was equipped with an alarm. However, the alarm did not
function.

Petitioner’s failure to assure that door alarms worked was a persistent problem. On

October 27, 2009, more than six weeks after the September 6 incident involving R-100, a
surveyor observed that the facility’s front door alarm was not functioning properly. CMS
Ex. | at 23.

The human element in this deficiency is the necessity that staff must check alarms
regularly and routinely to make sure that they operate as intended. Alarms are not like a
hot water heater that can be set and then ignored so long as it functions properly. They

6

must constantly be checked and calibrated. Failure by staff to perform this function on a
regular basis — as happened at Petitioner’s facility — is an invitation for malfunction and
that, in turn, provides a gateway to elopement.

Consequently, a facility may not provide sufficient assurance that it has corrected the
noncompliance by providing documentation that its staff have been trained in monitoring
and adjusting alarms. Rather, the staff must be observed performing these functions in
order to assure that they have been trained properly and that their training translates into
effective performance.

Petitioner’s noncompliance with the requirements of 42 C.F.R. § 483.25 is a failure by its
staff to provide residents with the necessary care and services to attain or maintain the
ighest practicable level of physical, mental, and psychosocial well being in accordance
with residents’ plans of care. The deficiency lies in the failure of the staff to provide a
resident, identified as R-104, with wound care treatments that are consistent with and in
compliance with a physician’s orders. This resident suffered from stasis ulcers on his
lower extremities. CMS Ex. 44. There were specific orders from a physician issued to
provide wound care to the resident. However, on several occasions the staff failed to
comply with those orders. CMS Ex. 45; CMS Ex. 46; CMS Ex. 50; CMS Ex. 51; CMS
Ex. 52; CMS Ex. 53. CMS documented a period of at least 48 hours beginning on
August 22, 2009 and continuing through August 24, 2009, during which the staff failed to
provide R-104 with prescribed care.

The compliance failure here clearly was human error. It consisted of a dereliction of duty
by Petitioner’s staff in that they failed to do what a physician had ordered them to do. As
with the previously discussed deficiency, documentation showing that the staff had been
retrained, or that protocols were in place for monitoring staff performance, is not
sufficient to assure that the relevant staff members actually did what was required of
them. Only observation could provide reasonable assurance that they had learned their
duties and were performing them correctly.

The third deficiency that I address is a quality of care deficiency involving failure by
Petitioner to comply with the requirements of 42 C.F.R. § 483.20(k)(3)(i), a regulation
that requires care to satisfy professionally recognized standards of quality. CMS’s
findings of noncompliance with this requirement again relate to the care that Petitioner
gave to R-104 and, specifically, are based on Petitioner’s staff’s failure to follow a
physician’s orders for wound care. As with the two other deficiencies that I discuss, the
errors that are involved are human errors directly implicating the staffs performance.
And also as with the two other deficiencies, this is a deficiency that cannot be certified to
have been corrected based solely on documentary evidence showing that the staff had
been retrained. As a matter of law observation of staff performance was necessary to
certify compliance.

/s/
Steven T. Kessel
Administrative Law Judge