Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Columbia Care and Rehabilitation Center
(CCN: 44-5465),

Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-10-176
Decision No. CR2212

Date: August 12, 2010

DECISION

Petitioner, Columbia Care and Rehabilitation Center (Petitioner or facility), is a long term
care facility located in Columbia, Tennessee, that participates in the Medicare program.
During a fire drill, conducted September 14, 2009, four of its six exits doors would not
unlock, and its smoke barrier doors failed to close. Based on these failings and other
cited deficiencies, the Centers for Medicare and Medicaid Services (CMS) determined
that the facility was not in substantial compliance with Medicare requirements. CMS
also determined that the facility’s fire safety deficiencies posed immediate jeopardy to
resident health and safety. CMS imposed civil money penalties (CMPs) of $6,800 for
one day of immediate jeopardy, and $200 per day for 44 days of noncompliance that was
not immediate jeopardy.

Petitioner here challenges only the deficiencies cited at the immediate jeopardy level.
CMS moves for summary judgment, which Petitioner opposes.

For the reasons set forth below, I find that CMS is entitled to summary judgment. The
undisputed evidence establishes that the facility was not in substantial compliance with
Medicare requirements and that its deficiencies pose immediate jeopardy to resident
health and safety.

I. Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in
the Medicare program and authorizes the Secretary of Health and Human Services to
promulgate regulations implementing those statutory provisions. Act §1819. The
Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the Medicare
program, a nursing facility must maintain substantial compliance with program
requirements. To be in substantial compliance, a facility’s deficiencies may pose no
greater risk to resident health and safety than “the potential for causing minimal harm.”
42 CFR. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a);
42 C.F.R. § 488.20. The regulations require that each facility be surveyed once every
twelve months and more often, if necessary, to ensure that identified deficiencies are
corrected. Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.

Here, following an annual re-certification survey, conducted from September 14-16,
2009, CMS determined, among other findings, that the facility was not in substantial
compliance with 42 C.F.R. §§ 483.25(h) (tag F323 — accident prevention and
supervision) and 483.75 (tag F490 — administration), as well as provisions of the Life
Safety Code of the National Fire Protection Association (LSC). CMS also determined
that these deficiencies posed immediate jeopardy to resident health and safety. CMS Exs.
1, 2; P. Ex. 3. Based on these deficiencies, CMS imposed a $6,800 per instance CMP. P.
Ex. 3.

Petitioner timely requested a hearing. CMS has filed a motion for summary judgment
with a brief in support (CMS Br.). Petitioner filed its opposition brief (P. Br.). CMS has
submitted 4 exhibits (CMS Exs. 1-4). Petitioner has submitted 5 exhibits (P. Exs. 1-5).

' Based on both the health and LSC survey findings, CMS cited additional deficiencies at
lower scope and severity levels. CMS Exs. 1, 2. CMS also determined that the facility
returned to substantial compliance on October 29, 2009. CMS Br. at 2. Petitioner does
not challenge these deficiencies, so they are final and binding and establish that the
facility was not in substantial compliance with program requirements. 42 C.F.R. §
498.20(b). They provide a sufficient basis for imposing a penalty. Act § 1819(h); 42
C.F.R. § 488.402.
IL. Issues
I consider whether summary judgment is appropriate.

On the merits, I consider: 1) whether the facility was in substantial compliance with 42
C.F.R. §§ 483.25(h), 483.75, and the LSC; and 2) if the facility was not in substantial
compliance with these requirements, whether its deficiencies pose immediate jeopardy to
resident health and safety.

Except to challenge the immediate jeopardy finding (which led to CMS’s imposing a
higher-range penalty), Petitioner does not claim that the amount of the CMP is
unreasonable, so that issue is not before me.

II. Discussion

A, CMS is entitled to summary judgment, because the
undisputed evidence establishes that the facility failed to
monitor and maintain the proper operation of its fire
alarm system. As a result: 1) the resident environment
was not as free of accident hazards as possible, as 42
CF.R. § 483.25(h) required; 2) the facility was not
administered in a manner that would effectively ensure
that its residents maintain their highest practicable well-
being and safety, as 42 C.F.R. § 483.75 required; and 3)
the facility did not meet applicable provisions of the
LSC.

Summary judgment. Summary judgment is appropriate here, because this case presents
no issue of material fact, and its resolution turns on questions of law. See Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986); Livingston Care Ctr. v. United States
Dep’t of Health and Human Servs., 388 F.3d 168, 173 (6th Cir. 2004). See also Illinois
Knights Templar Home, DAB No. 2274 at 3-4 (2009) (citing Kingsville Nursing Ctr.,
DAB No. 2234 at 3-4 (2009)). Although Petitioner opposes summary judgment, it has
not challenged a single material fact. Instead, it makes the wholly legal argument that the
immediate jeopardy determination, like the noncompliance finding, “must be supported
by substantial evidence on the administrative record as a whole.” P. Br. at 6. Not only
does this fail to raise a material fact, nothing in CMS’s submissions even suggests that
CMS disagrees with Petitioner’s statement of that legal standard.

Regulatory requirements. Under the statute and the “quality of care” regulation, each
resident must receive, and the facility must provide, the necessary care and services to
allow a resident to attain or maintain the highest practicable physical, mental, and

psychosocial well-being, in accordance with the resident’s comprehensive assessment
and plan of care. Act § 1819(b); 42 C.F.R. § 483.25. To achieve this goal, the facility
must “ensure” that the resident’s environment remains as free of accident hazards as
possible. Briarwood Nursing Ctr., DAB No. 2115, at 5 (2007); Guardian Health Care
Center, DAB No. 1943, at 18 (2004) (citing 42 C.F.R. § 483.25(h)(2)).

The facility must also be administered in a manner that enables it to use its resources
effectively and efficiently to attain or maintain the highest practicable physical, mental,
and psychosocial well-being of each resident. 42 C.F.R. § 483.75.

Finally, the facility must be designed, constructed, equipped, and maintained to protect
the health and safety of its residents, personnel, and the public. In this regard, it must
meet provisions of the LSC. Act § 1819(d)(2)(B); 42 C.F.R. § 483.70(a). The LSC is a
set of fire protection requirements designed to provide a reasonable degree of safety from
fires. Among other requirements, the LSC mandates that smoke barrier doors close
automatically when the facility’s alarm system is activated. CMS Ex. 2 at 2-3. Locked
exit doors must unlock during the activation of the alarm system. CMS Ex. 2 at 345-46.

Application of law to the undisputed facts. The parties agree that part of the LSC survey
included a fire drill, which was conducted on September 14, 2009. During the drill, the
facility’s two smoke barrier doors did not close, and four of six exit doors on the
facility’s main residential level did not unlock. CMS Ex. 1 at 10; CMS Br. at 2; P. Br. at
1. The facility thereafter called in the fire alarm company, and service workers came out
that same day to repair the equipment failure. P. Ex. 1 at 5.

Petitioner argues that it should not be held accountable for the system’s failure, because,
prior to the September 14 drill, it did not know, or have reason to know, that its system
was not working properly. In fact, the undisputed evidence establishes otherwise. As
Petitioner acknowledges, its system had been malfunctioning since at least July 3. A fire
alarm service order, dated July 3, 2009, describes problems with door locks not releasing
during a fire alarm. According to the order, the relay controlling the doors’ magnetic
locks did not work, or worked intermittently. CMS Ex. | at 13; see P. Ex. | at 5
(highlighting that the system required repairs on May 21, July 3, August 25, August 26,
and August 31, 2009).

> Neither party cited the relevant provisions of the LSC, but they agree that these are LSC
requirements.
The facility installed a new alarm panel on August 25-26, 2009. CMS Ex. | at 12-14;
CMS Ex. 3.°> However, that system soon required repair. On August 31, 2009, the alarm
company workers found “several wires connected incorrectly.” The system then required
additional repairs on September 15. CMS Ex. | at 14 (asserting that workers “made
corrections in panel and [junction] box cabinets to wiring and replaced relays to get
system operational again.”’). Notwithstanding the problems it had with the alarm system
after installing the new alarm panel, the facility did not test it by conducting a single fire
drill. CMS Ex. 1 at 12; P. Ex. 1 at 5; P. Ex. 4 at 4 (noting prior to survey, the last fire
drill was conducted on August 21, 2009).

Petitioner points to its having conducted an abundance of fire drills, but all were prior to
its (apparently incorrectly) installing the new alarm panel. Petitioner admits that the new
system did not function properly, requiring additional repairs on August 31. The facility
thus had ample reason to suspect that its alarm system might malfunction. After all,
repairs had been made before, with the system pronounced functional when it was not.
Yet, the facility conducted no drills to test it. In this regard, the facility fell short of its
regulatory obligations. As the Departmental Appeals Board (Board) explained in Sunset
Manor:

[The facility’s] responsibility was not merely to have an
alarm system installed and operational. That requirement is
just one element of a facility’s overarching obligation under
section 483.70 to equip and maintain its facility in a manner
that actually does “protect the health and safety of residents,”
as well as staff and the public. Hence, the facility must do
more than merely hook up its fire alarm system . . . and hope
for the best. It must take reasonable steps to ensure that its
alarm system and associated protocols operated to achieve
their intended purpose in the circumstances for which they
were designed.

Sunset Manor, DAB No. 2155, at 11 (2008).

> The facility failed to submit the new alarm panel for State Agency approval. Petitioner
concedes that the system must be approved; however, Petitioner questions whether that
approval must precede installation. Petitioner points out that it needed to make
immediate repairs, so it did not have time for advance approval. P. Br. at 4. This may
be, but weeks passed without the facility’s notifying the state. Following the survey, the
facility sent to the state agency the specifications for the replacement fire alarm panel,
which were subsequently approved. P. Ex. 1 at 1 (Miller Affidavit § 6). Of course, by
the time they submitted the information, the new system had failed and been repaired.
Because the facility did not take the “reasonable step” of conducting at least one fire drill
to ensure that its new alarm system operated properly, the facility did not ensure that the
resident environment was as free of accident hazards as possible (42 C.F.R. § 483.25(h)),
nor that all requirements of the LSC were met (see 42 C.F.R. § 483.70(a)). Further, these
deficiencies establish that the facility was not administered in a manner that enabled it to
use its resources effectively and efficiently to maintain the highest practicable well-being
of its residents (42 C.F.R. § 483.75). The facility was therefore not in substantial
compliance with Medicare requirements.

B. CMS’s immediate jeopardy finding is not clearly
erroneous.

Petitioner challenges the immediate jeopardy determination. It again argues that it could
not have foreseen the alarm system’s malfunction and points out that, after the alarm
system malfunctioned, it quickly corrected the problems. In Petitioner’s view, these
factors preclude my finding immediate jeopardy.

Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause
“serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.

CMS’s determination as to the level of a facility’s noncompliance (which would include
an immediate jeopardy finding) must be upheld, unless it is “clearly erroneous.” 42
C.F.R. § 498.60(c). The Board has observed repeatedly that the “clearly erroneous”
standard imposes on facilities a “heavy burden” to show no immediate jeopardy, and has
sustained determinations of immediate jeopardy where CMS presented evidence “from
which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” Daughters of
Miriam Ctr., DAB No. 2067 at 7, 9 (2007); Barbourville Nursing Home, DAB No. 1931
at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)).

Petitioner has not come close to meeting this standard. First, as the above discussion
shows, Petitioner had ample notice that its alarm system might not function properly
when needed, but did not once test its new system by conducting a fire drill. Second, that
it promptly brought in workers to correct the system’s problem may have justifiably
limited the period of immediate jeopardy to one day; however, it neither eliminated the
deficiency, nor decreased its scope and severity.

Indeed, Petitioner’s failure to ensure that its new alarm system worked properly created a
situation likely to cause serious injury, harm, impairment, or death to a resident.
Because the smoke barrier doors would remain open during a fire, the fire and its
accompanying smoke would have spread, unchecked, through the residences. And,
because the exit doors remained locked and could not be opened, facility residents and
staff could have been locked in a burning building. Because of this, I do not find clearly
erroneous CMS’s determination that the facility’s failure to ensure that its alarm system
worked properly posed immediate jeopardy to resident health and safety.

IV. Conclusion

For the reasons discussed above, | find that the facility was not in substantial compliance
with the Medicare requirements. Its deficiencies posed immediate jeopardy to resident
health and safety, and I affirm as reasonable the penalty imposed.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Troy Health & Rehabilitation Center
(CCN: 01-5213),

Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-08-615
Decision No. CR2209

Date: August 11, 2010

DECISION

I conclude that Petitioner, Troy Health & Rehabilitation Center, substantially complied
with the Medicare participation requirement governing quality of care under 42 C.F.R.
§ 483.25. Petitioner did not manifest any immediate jeopardy level failures to comply
with this participation requirement. Therefore, the Centers for Medicare and Medicaid
Services (CMS) had no basis for imposing a per instance civil money penalty (CMP) of
$6,000 against Petitioner.

I. Background

Petitioner is a long-term care facility located in Troy, Alabama. Petitioner is authorized
to participate in the federal Medicare program as a skilled nursing facility (SNF) and in
the Medicaid program as a nursing facility (NF). Transcript (Tr.) at 101. From April 30,
2008 to May 3, 2008, the Alabama Department of Public Health, Division of Health Care
Facilities (state survey agency) conducted a complaint survey of the facility. The state
survey agency determined that Petitioner was not in substantial compliance with the
Medicare participation requirement found at 42 C.F.R. § 483.25 (Tag F309) and cited the
alleged deficiency at the immediate jeopardy scope and severity level.
By letter dated May 14, 2008, the state survey agency notified Petitioner of the survey
results. P. Exhibit (Ex.) 2. The state survey agency informed Petitioner that it was found
not in substantial compliance with participation requirements and that past
noncompliance immediate jeopardy was found to exist. The state survey agency advised
Petitioner that it was recommending that CMS impose a per instance CMP of $5,000.

In a notice letter dated May 21, 2008, CMS advised Petitioner that, based on the findings
of the May 3, 2008 complaint survey, it was imposing a per instance CMP of $6,000 for
Tag F309, and loss of approval of a nurse aide training and competency evaluation
program. P. Ex. 3. CMS noted that Petitioner was currently in substantial compliance.

Ina letter dated July 15, 2008, Petitioner timely requested a hearing.

I conducted an in-person hearing in Montgomery, Alabama, on September 29-30, 2009.
CMS offered exhibits (CMS Exs.) 1 through 19, and Petitioner offered P. Exs. 1 through
42. I admitted all of the exhibits into evidence. Tr. at 8,9. CMS elicited testimony from
Sammy Bean, a state agency surveyor. Petitioner elicited testimony from: James Warren
Kelly, Petitioner’s Administrator; Patty Herndon, Petitioner’s Director of Nursing;
Margarette Calhoun, RN supervisor at Petitioner’s facility; Catherine Ward, a licensed
practical nurse (LPN) at Petitioner’s facility; Luvonne Jones, a certified nurse aide
(CNA) at Petitioner’s facility; Wanda Mote, an LPN at Petitioner’s facility; Richard
Duszak, Jr., M.D.; and Satinderjit Rick Gill, M.D.

Each party submitted a post-hearing brief (CMS Brief and P. Brief, respectively).
Petitioner submitted a post-hearing reply brief. By letter dated March 26, 2010, CMS
advised that it opted not to file a post-hearing reply brief. Each party received a copy of
the hearing transcript.

IL. Issues

The issues before me are:

(1) whether the facility was in substantial compliance with 42 C.F.R. § 483.25 at
the time of the May 3, 2008 survey; and

(2) ifthe facility was not in substantial compliance, whether the penalty imposed,
a $6,000 per instance CMP, was reasonable.
Ill. Applicable Law and Regulations

Petitioner is considered a long-term care facility under the Social Security Act (Act) and
regulations promulgated by the Secretary of Health and Human Services (Secretary).

The statutory requirements for a long-term care facility’s participation are found at
sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483. Sections 1819 and 1919 of
the Act vest the Secretary with authority to impose CMPs, and other remedies, against a
long-term care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS the authority to impose various
remedies against a long-term care facility that is not complying substantially with federal
participation requirements. Facilities that participate in Medicare may be surveyed on
behalf of CMS by State survey agencies to ascertain whether the facilities are complying
with participation requirements. 42 C.F.R. §§ 488.10-488.28; 42 C.F.R.

§§ 488.300-488.335. Under Part 488, CMS may impose a per instance or per day CMP
against a long-term care facility when a State survey agency ascertains that the facility is
not complying substantially with participation requirements. 42 C.F.R. §§ 488.406,
488.408, 488.430. The regulations in 42 C.F.R. Part 488 also give CMS a number of
other remedies that can be imposed if a facility is not in compliance with Medicare
requirements.

Pursuant to 42 C.F.R. Part 488, CMS may terminate a long-term care facility’s provider
agreement when a survey agency concludes that the facility is not complying
substantially with federal participation requirements. CMS may also impose a number of
alternative enforcement remedies in lieu of or in addition to termination. 42 C.F.R.

§§ 488.406, 488.408, 488.430. In addition to termination and the alternative remedies
CMS is authorized to impose, pursuant to section 1819(h)(2)(D) of the Act and 42 C.F.R.
§ 488.417(b), CMS must impose the “mandatory” or “statutory” denial of payment for
new admissions (DPNA). Section 1819(h)(2)(D) requires the Secretary to deny Medicare
payments for all new admissions to a SNF, beginning 3 months after the date on which
such facility is determined not to be in substantial compliance with program participation
requirements. The Secretary has codified this requirement at 42 C.F.R. § 488.417(b).

The regulations specify that a CMP imposed against a facility can be either a per day
CMP for each day the facility is not in substantial compliance or a per instance CMP for
each instance that a facility is not in substantial compliance. 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 broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The
upper range of CMP, from $3,050 per day to $10,000 per day, is reserved for deficiencies
that constitute 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). The lower range of CMP,
from $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). Only a single range of $1,000 to $10,000 exists for a per instance
CMP, which applies whether or not immediate jeopardy is present. 42 C.F.R.

§§ 488.408(d)(1)(iv), 488.438(a)(2).

The regulations define the term “substantial compliance” to mean “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. Noncompliance that is immediate jeopardy is defined as “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.”
Id. The Act and regulations make a hearing before an administrative law judge (ALJ)
available to a long-term care facility against whom CMS has determined to impose a
CMP. Act Section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). The hearing
before an ALJ is a de novo proceeding. 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.” See 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e),
498.3. However, CMS’s choice of remedies, or the factors CMS considered when
choosing remedies, are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may
only challenge the scope and severity level of noncompliance that CMS found, if a
successful challenge would affect the amount of the CMP that CMS could collect

or impact upon the facility’s nurse aide training program. 42 C.F.R. § 498.3(b)(14)(i),
(ii). CMS’s determination as to the level of noncompliance “must be upheld unless it is
clearly erroneous.” 42 C.F.R. § 498.60(c)(2). This includes CMS’s finding of immediate
jeopardy. Woodstock Care Ctr., DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care
Ctr. v. U.S. Dep’t. of Health & Human Servs., 363 F.3d 583 (6th Cir. 2003). The
Departmental Appeals Board (the Board or DAB) 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 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). Review of a CMP by an ALJ is governed by 42
CFR. § 488.438(e).

In a CMP case, CMS must make a prima facie case that the facility has failed to comply
substantially with participation requirements. To prevail, a long-term care facility must
overcome CMS’s showing by a preponderance of the evidence. Hillman Rehab. Ctr.,

DAB No. 1611 (1997); aff'd, No. 98-3789, 1999 WL 34813783 (D.N.J. May 13, 1999).

IV. Findings of Fact, Conclusions of Law, and Discussion

I make one finding of fact and conclusion of law to support this decision. I set it forth
below as a separate heading in bold type and then discuss it in detail.
The preponderance of the evidence establishes that Petitioner was complying
substantially with the requirements of 42 C.F.R. § 483.25 (Quality of Care,
Tag F309).

The regulation at 42 C.F.R. § 483.25 requires that “[e]ach resident must receive and the
facility must provide the necessary care and services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being, in accordance with the
comprehensive assessment and plan of care.”

CMS’s allegations of noncompliance with 42 C.F.R. § 483.25 pertain to the care
provided to Resident 1 (R1). With respect to this citation, the Statement of Deficiencies
(SOD) alleges that, based on interviews, medical record reviews, and the facility’s policy
and procedure for “Gastric Tube Insertion” dated June 1, 2004, Petitioner’s nurse
identified as RN #1 “failed to verify correct placement of a Gastrostomy tube (G-tube)
after re-inserting the G-tube on [R1] on the morning of 2/9/08. Also, RN #1 failed to
document the procedure (G-tube re-insertion) in [R1’s] medical [sic] according to the
facility’s policy.” The SOD alleges also that “the Staff Development Coordinator failed
to provide RNs employed by the facility educational training on proper G-Tube re-
insertions with demonstrated skill competency prior to allowing the RNs to re-insert G-
Tubes in the facility.” CMS Ex. 1, at 1-2; P. Ex. 1, at 1-2. Additionally, besides alleging
that Petitioner failed to properly insert R1’s G-tube and verify its placement, as well as
failed to document this, CMS alleges in its post-hearing brief that Petitioner’s
noncompliance necessitated surgical intervention to remove dead tissue (referred to as
necrotizing fasciitis) that developed as a result of the improper tube placement, placing
R1 in immediate jeopardy of physical harm.' CMS Brief at 9, 11.

With respect to the incident that occurred on February 9, 2008, the SOD states that
“Ta]ecording to the facility, the off-going shift [certified nursing assistant (CNA)] #2
observed [that R1’s] G-tube [was] in place around 5:00 a.m. on 2/9/08.” Around 7:15
a.m., CNA #1 found R1’s G-tube dislodged and lying in her bed. Following this
discovery, RN #1 re-inserted R1’s G-tube. The SOD alleges that RN #1 admitted that
she failed to verify the correct placement of the G-tube, after she re-inserted it, and failed
to document the re-insertion of the G-tube. CMS Ex. 1, at 2; P Ex. 1, at 2.

According to the SOD, three days later, on February 12, 2008, R1 complained of
abdominal pain and was transferred to a local hospital emergency room. The SOD
alleges that x-rays of her abdomen confirmed that the G-tube was in the subcutaneous
tissue of the abdomen and was not correctly placed in her stomach. CMS Ex. 1, at 2; P.
Ex. 1, at 2. The SOD alleges that Petitioner’s deficient practice posed an immediate
threat to the health and safety of R1. CMS Ex. 1, at 2; P. Ex. 1, at 2.

' According to Dr. Duszak, necrotizing fasciitis is a severe infection of the tissue. Tr. at
214-15.
R1, an 87-year old female at the time of the survey, was first admitted to Petitioner’s
facility on October 14, 2003, and was readmitted on November 8, 2007. P. Ex. 5, at 1;
CMS Ex. 9, at 1, 26, 28. As stated in the SOD, R1’s diagnoses included: pyelonephritis;
dehydration; renal and urethral disorder; nonpsychotic disorder; peripheral vascular
disease; bilateral amputation; arthropathy; and abnormal blood chemistry. CMS Ex. 1, at
3; P. Ex. 1, at 3. I note that R1’s minimum data set (MDS) assessment dated October 21,
2003, and other records, show that R1 was also diagnosed with anemia, dementia,
Alzheimer’s disease, hypertension, hypoalbuminemia, hypokalemia, and colon cancer. P.
Ex. 5, at 4.

The SOD states that R1’s MDS assessment, dated January 8, 2008, shows that R1 had
short and long term memory problems, as well as severely impaired cognitive skills for
daily decision making. CMS Ex. 1, at 3; P. Ex. 1, at 3; see CMS Ex. 9, at 28. R1 was
totally dependent on staff for all activities of daily living, and R1’s bowel and bladder
was incontinent. In the “Nutritional Approaches” section of the MDS, staff noted that R1
ad a feeding tube for nutritional support. CMS Ex. 1, at 3; P. Ex. 1, at 3.

According to the SOD, R1’s care plan, dated November 8, 2007, documented that she

ad a G-tube related to dysphasia and poor oral intake. The care plan listed as a goal that
R1 would have no risk of complications related to the G-tube. Among the care plan
interventions were: “[c]heck placement of G-tube before giving medications, water, or
feedings; . . . [I]isten to lung sounds as needed; . . . [c]hange tube per MD orders; . . .
c]heck residual per MD order; . . . [m]Jonitor/report irritation, redness of G-tube site; ...
f]lush tube with water as ordered. 60 cc after feedings; [f]lush tube with water post
medicine; . . . [c]heck residual Q [every] shift — if > 100 cc, hold feeding x 1 hr &
recheck after feeding.” CMS Ex. 1, at 3-4; P. Ex. 1, at 3-4; see CMS Ex. 9, at 31.

The SOD states that R1’s G-tube was found dislodged around 7:00 a.m. on February 9,
2008, which R1 re-inserted around 7:15 a.m. It is alleged that no documentation existed
in the nurse’s notes. The SOD states that the “[t]he only nurse entry for this date
[2/9/08]” indicated that R1’s G-tube was patent and intact, placement was verified, with
no residual noted, and that R1 was tolerating her bolus feedings well. CMS Ex. 1, at 4; P.
Ex. 1, at 4.

According to the SOD, a nurse’s note dated February 11, 2008 (shift 10-6), shows that R1
was “[rJesting in bed yelling out complaining [with] G tube site hurting & stomach
hurting.” The nurse’s note stated also that the placement of R1’s G-tube was checked,
and no residual was noted. R1 was medicated with Tylenol, and no nausea, vomiting, or
diarrhea was noted. CMS Ex. 1, at 4; P. Ex. 1, at 4.

A nurse’s note dated February 12, 2008, at 10:15 a.m., shows that staff was notified to
check R1’s G-tube site. The note states “[r]eport pulled out tube on Sat. Replaced. In to
see. Noted site large gaping. Foul smelling thin brownish drainage from site. Mod.
amt.” The note states that the nurse notified R1’s physician and received orders to send
R1 to the emergency room for evaluation. CMS Ex. 1, at 10; P. Ex. 1, at 10; see CMS
Ex. 9, at 65; P. Ex. 26, at 32; P. Ex. 28, at 2.

The SOD refers to R1’s hospital records from Troy Regional Medical Center, where R1
was transferred on February 12, 2008. The SOD notes that R1’s “History and Physical”
stated:

[R1] ... presented to the ER on 2/12/08 secondary to nursing
home personnel noting that the tube feedings were exuding
from the abdominal wall and apparently she had the PEG tube
replaced on Saturday, 2/9/08, and since than [sic] time she
has been getting the usual tube feedings. In the ER it is
evident that the tube feedings have been placed
subcutaneously. Dr. Gill was consulted to see the patient in
the ER and after evaluation determine [sic] that she needed
immediate abdominal wall debridement and surgery.

CMS Ex. 1, at 10; P. Ex. 1, at 10; see CMS Ex. 9, at 100.

The SOD also refers to the hospital consultation report for R1 (dictated by Dr. Gill, Tr. at
276) dated February 12, 2008, and notes that it states the following in the “History”
section:

I am being consulted in the ER for evaluation of cellulitis,
subcutaneous emphysema and leukocytosis and abdominal
pain in the ER. .. . Per the record she had a PEG tube placed
in the past and they changed out the tube on Saturday and
since that time she has been getting feedings but today they
noticed the tube feedings were coming out of the abdominal
wall so she was sent to the ER. In the ER they evaluated it
and found that she had the tube completely dislodged. They
ordered multiple studies . . . that showed the tubes to be in the
subcutaneous tissues and she also had a CT scan of abdomen
and pelvis done and this showed no intraabdominal free air or
fluid but a large collection of material in the subcutaneous
tissues . . . she does state that she hurts every time I press on
her abdominal cavity.

CMS Ex. 1, at 11; P. Ex. 1, at 11; see CMS Ex. 9, at 103.
The SOD also reflects that Surveyor Bean conducted interviews with Petitioner’s

employees CNA #1, LPN #1, and RN #1, and with the surgeon, Dr. Gill. CMS Ex. 1, at
6-9, 11-12; P. Ex. 1, at 6-9, 11-12. According to the record, CNA #1 is Luvonne Jones
(Tr. at 17, 41, 85, 175), LPN #1 is Catherine Ward (Tr. at 17, 154), and RN #1 is
Margarette Calhoun (Tr. at 48). As stated above, Ms. Jones, Ms. Ward, Ms. Calhoun,
and Dr. Gill were among the witnesses who testified at the hearing.

Petitioner argues that the evidence demonstrates that its nursing staff appropriately
reinserted and monitored R1’s G-tube. Petitioner argues that its staff had received
appropriate training and education regarding the reinsertion of G-tubes and verification of
its placement and is experienced in providing care to residents requiring G-tube feedings.
Further, Petitioner contends that no evidence exists that the necrotizing fasciitis, which
R1 developed, was caused by any action or inaction by its staff.

I find that, based on its fact contentions, CMS has made a prima facie case as to the
alleged deficiency cited under Tag F309 — but just barely. Petitioner, however, has
offered evidence to rebut CMS’s prima facie case that proves that it complied
substantially with participation requirements. Consequently, I do not sustain CMS’s
allegations of noncompliance.

There is no dispute that, between 7:00 and 7:30 a.m. on Saturday, February 9, 2008, R1
pulled out her G-tube, and CNA Jones discovered that it was out of her stomach. Tr. at
173. (Apparently, R1 had been combative while receiving a bath during her morning
care and had pulled out her G-tube. See P. Exs. 35, 36). CNA Jones saw LPN Ward in
the hall passing out medications and told LPN Ward that R1 had pulled out her G-tube.
Tr. at 149, 173, 177. LPN Ward then called her RN supervisor, RN Calhoun. Tr. at 141,
149. RN Calhoun reinserted R1’s G-tube in the presence of LPN Ward and CNA Jones.
Tr. at 137-38, 141, 149-50. RN Calhoun did not verify the placement of the G-tube
herself, apparently because she did not have a stethoscope with her. Tr. at 142, 164-65.
She told LPN Ward to verify the placement of the G-tube. Tr. at 138. RN Calhoun did
not document in the nurse’s notes that she reinserted the G-tube, because she believed
that LPN Ward would do this task. Tr. at 139. LPN Ward checked the placement of the
G-tube by injecting air into the tube as she listened with the stethoscope, a method called
auscultation.” Tr. at 150-51; see Tr. at 220-23. It appears that verification of placement
took place somewhere between 10 and 30 minutes after the reinsertion of the G-tube. Tr.
at 142-43, 153. LPN Ward did not document in the nurse’s notes that RN Calhoun

> In explaining how she checked the placement of R1’s G-tube, LPN Ward stated, “I had
a 60 cc feeding syringe and a stethoscope. I injected 30 ccs of air into the feeding tube as
I listened over the stomach, listening for the swishing sound, and then at that moment, I
pulled back on the syringe and checked for residual.” Tr. at 150-51. According to Dr.
Duszak, Petitioner’s expert witness, clinical providers routinely use auscultation to verify
placement of a G-tube. Tr. at 220. Dr. Duszak explained that the sound made when air is
injected into the stomach is “very, very distinctive” and stated that, if a G-tube was
improperly placed into the soft tissues, you would not be able to inject air easily because
of resistance, and you would not really hear any sound. Tr. at 220-23. Surveyor Bean
described the auscultation method as well in his testimony. Tr. at 45.
replaced R1’s G-tube, but she did document with her initials on R1’s Medication
Administration Record (MAR) that she verified placement of the G-tube. Tr. at 139, 152,
161-63; see P. Ex. 29; CMS Ex. 9, at 113, 114. On February 10 and 11, 2008,
Petitioner’s staff indicated in the nurse’s notes that the placement of R1’s G-tube was
checked, noted to be patent, and no residual was noted. P. Ex. 28. On February 12,
2008, at 10:15 a.m., a nurse noted that there was foul-smelling, thin brownish drainage
from the G-tube site. The nurse notified R1’s physician, who ordered R1 to be sent to the
emergency room for evaluation. P. Ex. 28, at 2. At the Troy Regional Medical Center
ER, it was observed that her G-tube had become dislodged. P. Ex. 30, at 1. R1 received
evaluations and various tests. Dr. Gill diagnosed, among other things, possible
necrotizing fasciitis of her left upper quadrant and performed surgery on R1, which
consisted of “debridement of skin, subcutaneous tissues, muscles and fascia.” P. Ex. 30,
at 2; P. Ex. 31, at 1.

Although CMS would have me find from the evidence it presented that Petitioner’s staff
improperly reinserted R1’s G-tube on February 9, 2008, I am unable to reach this
conclusion based on the record before me, especially in light of the testimony of Drs.
Duszak and Gill, which I discuss below. Moreover, I find no basis to conclude that RN
Calhoun and LPN Ward did not have the proper training regarding G-tubes to carry out
their respective RN and LPN duties.

The only witness CMS presented in support of its case was Surveyor Bean, who
conducted the survey of Petitioner’s facility. Surveyor Bean testified that he drafted the
allegations under Tag F309 in the SOD. Tr. at 94. He testified about his interviews with
CNA Jones, LPN Ward, RN Calhoun, and Dr. Gill.

According to Surveyor Bean, Petitioner’s staff failed “to ensure that [R1’s] gastrostomy
tube was properly placed and was checked for placement for verification so that she
could safely receive her nutritional support via the G-tube.” Tr. 77. Surveyor Bean
stated, moreover, that Petitioner failed “to ensure that the RN that was on staff had
competency skills” with respect to G-tubes. Tr. 77. When asked how R1’s life was
placed in immediate jeopardy, Surveyor Bean stated that the improper placement of the
G-tube “could cause complications” and “could cause what they actually found in the ER,
which was dead tissue, which could cause her to become septic, and she could go into
septic shock and die.” Tr. at 77-78.

Surveyor Bean testified that no documentation existed in the nurse’s notes that R1’s G-
tube had come out and was replaced on February 9, 2008. Tr. at 29, 35-36, 76. He
testified that RN Calhoun, who reinserted the G-tube, told him in their interview that she
did not document this information, because she thought LPN Ward would do it. Tr. at
53-54. Surveyor Bean noted that it is usually an RN who replaces the G-tube and that an
LPN can verify the insertion. Tr. at 46, 52. Surveyor Bean testified that LPN Ward told
him in an interview that she had verified placement of the G-tube and documented this on
the MAR. Tr. at 48, 52, 79-80.

10

Surveyor Bean also testified concerning two internal policies that were in effect in
February 2008 at Petitioner’s facility: one policy, entitled “Gastric Tube Insertion”
(CMS Ex. 9, at 81); and another policy, entitled “Documentation Guidelines for Skilled
Care -- Enteral Feeding: Nasogastric — Gastrostomy — Jejunostomy” (CMS Ex. 9, at 90).
According to Surveyor Bean, the first policy sets forth the steps to follow when inserting
a G-tube. Tr. at 70-71. With respect to the second policy, Surveyor Bean testified that it
sets forth documentation expectations for residents having G-tubes. Tr. at 73-74.
Surveyor Bean noted that documentation was required when, among other things: the
tube position was checked; verification of placement was done; and the tube was replaced
(noting reason, type of tube/size). Tr. at 74-75. According to Surveyor Bean,
Petitioner’s staff did not follow its own policies. Tr. at 71-72, 76.

When questioned about his interview with the surgeon, Dr. Gill, Surveyor Bean testified,
among other things, that Dr. Gill had opined that “the tube was probably forced into the
fascia.” Tr. at 67. Surveyor Bean acknowledged that, following their interview on May
1, 2008, a letter written by Dr. Gill dated May 2, 2008, came into his office while he was
writing the SOD and that it was inconsistent with his interview with Dr. Gill. Tr. at 68,
69, 94; see CMS Ex. 9, at 13.3 Surveyor Bean stated, “on the statement here, he’s saying
that he don’t know how the tube was displaced, but during the interview, he told me that
it was improperly done, that it was improperly forced in by the nurse.” Tr. at 69; see Tr.
at 86. Surveyor Bean said that Dr. Gill did not contact him to clarify his interview
statements, nor did he contact Dr. Gill regarding his letter. Tr. 69-70, 89. Despite being
confronted by Petitioner’s counsel with other alleged instances where he misquoted or
misrepresented what Dr. Gill said in their interview, Surveyor Bean stated that he stood
by all his statements in the SOD. Tr. at 89.

Petitioner attempted to show that Surveyor Bean was biased on the grounds that his aunt
is a resident at Petitioner’s facility and that his mother and R1 were “longtime neighbors
in Troy.” Tr. at 90. Surveyor Bean did not deny that his aunt resides at Petitioner’s
facility, nor did he deny that his mother and R1 were longtime neighbors. Tr. at 90-92.
Surveyor Bean stated that he went to the same high school as two of R1’s children.
When asked whether he had disclosed his family’s relationship to Petitioner’s facility at
the time of the survey, Surveyor Bean said he had not. Tr. at 91. Surveyor Bean stated
that his family “did not have a relationship” with R1 and took issue with Petitioner’s
counsel’s characterization. Tr. at 92. According to Surveyor Bean, “[his] mother knows
[R11]; I know her children, but I’m not friends, per se, that we go out and we hang out
together.” Jd. He stated that, prior to the survey, he had disclosed the information
concerning his aunt and his mother to his superiors at the state survey agency and had
asked whether another surveyor could perform the survey; however, his superiors
determined that no conflict of interest existed and approved him to conduct the survey.
Tr. at 91-93, 95. Surveyor Bean stated that it was not his first time surveying Petitioner’s
facility, and he had provided a written statement advising his office of the conflict of

> Dr. Gill addressed his letter to Dr. Peter DiChiara, Petitioner’s Medical Director.
11

interest. According to Surveyor Bean, although concerns had been raised in the past, he
was still sent out to survey Petitioner’s facility. Tr. at 92, 96.4 Surveyor Bean stated, “if
they [i.e. the state survey agency] deem that you can go do your job without being biased,
then you would be given that assignment. But they still like to know all facilities that you
ave a conflict of interests with.” Tr. at 98.

In examining Surveyor Bean’s testimony, I do not find that Petitioner was able to show
that he was biased. I find that, in accordance with his office policy, Surveyor Bean
appropriately disclosed to his superiors any potential conflicts of interest arising from any
amily ties to the facility, and, when they sent him to the facility to conduct the May 3,
2008 survey, he acted in a professional manner. While I ultimately conclude that
Surveyor Bean’s testimony was unpersuasive and not entitled to much weight, I do not
base that conclusion on any finding of bias on his part.

To rebut CMS’s arguments, Petitioner offered the expert medical testimony of Dr.
Richard Duszak, Jr., via telephone. Dr. Duszak is a dual board-certified radiologist with
a primary certification in diagnostic radiology and a subspecialty certification in vascular
and interventional radiology. Tr. at 199. Dr. Duszak is employed by Mid-South Imaging
and Therapeutics in Memphis, Tennessee. Tr. at 202. He testified that he routinely sees
patients in long-term care facilities and estimated that, over the course of a year, he
provides care to approximately 100 patients with G-tubes. Tr. at 202. I qualified Dr.
Duszak as an expert “in the areas of radiology and the areas of long-term care and
treatment of residents with G-tubes.” Tr. at 204.

Dr. Duszak testified that a G-tube goes through the anterior abdominal wall, through the
peritoneal cavity, directly into the stomach, and is “usually for long-term enteral . . .
eedings.” Tr. at 204, 206. He testified that “every patient with a gastrostomy tube is at
risk of complications related to the tube” and that this is why placement of a G-tube is
done after a discussion with the patient and family. Tr. at 210. Dr. Duszak stated that the
tube, by its very presence, puts a patient at risk for bleeding, malposition, bowel injury,
and infection. Dr. Duszak stated that these “are acceptable risks of complications if
maintained appropriately.” Tr. at 210-11.

Dr. Duszak opined that, based on his review of R1’s records and to a reasonable degree
of medical certainty, there was “no way that [he], as a practicing physician with
experience in this area, could ever in any way reasonably draw” the conclusion that,
based on R1’s condition when she went to the hospital, her G-tube was improperly
reinserted on February 9, 2008. Tr. at 217. As support for his opinion, Dr. Duszak
testified as follows:

* Surveyor Bean testified that, prior to conducting the May 2008 survey of Petitioner’s
facility, he had surveyed the facility twice before. Tr. at 22. He stated that if a surveyor
had previously been employed at a long-term care facility or had family members who
were residents at a facility, he or she is required to disclose the facility’s name “and put it
on the list and give it to your supervisor.” Tr. at 98.
12

[I]t’s my opinion that the evidence is quite strong to the
contrary. There are numerous instances between the time that
the gastrostomy tube was replaced on the 9" until the time of
hospital admission on the 12" where nurses documented
several times verification of the tube position. And in
addition, there is an overwhelming amount of evidence based
upon a several year period . . . in which this patient has
frequently pulled her tube out, and in fact, on another
occasion, had an infection -- fortunately at that time less
severe -- related to her displacing her tube. So it’s my
opinion that the overwhelming evidence is not that the tube
was misplaced, but that the tube was in fact displaced by the
resident herself probably a couple of days after it was
appropriately replaced, again, after she pulled it out at the
time of a bath or some other care the morning of the 9".

Tr. at 217-18.° Dr. Duszak testified further that, in his professional opinion and to a
reasonable degree of medical certainty, R1’s necrotizing fasciitis was not caused by an
improper placement of the G-tube by the RN on February 9, 2008. Tr. at 234.

On cross-examination, despite CMS counsel’s attempts to cast doubt on his opinions, Dr.
Duszak reiterated his earlier testimony:

[I]f you want a specific, you know, hour and second on the
clock as to when the nursing home resident dislodged her
tube, I can’t give you a specific time. But what I can state
with as much reasonable medical certainty as I possibly can
put forth is that the tube was replaced appropriately on the 9".
There’s documentation for the subsequent days that it was
confirmed to be in good position. Tube feeds were
administered through the tube for some period of time
without any untoward consequences, and then at some point
on the 12", things went bad. And the only explanation I have

* Dr. Duszak testified that R1’s chart indicated “at least five documentations over the
course of several years going back to 2003” where R1, because of her dementia, pulled at
her tube and, in fact, pulled it out. Tr. at 212. Dr. Duszak noted that, in 2005, R1 was
admitted to the hospital with a cellulitis infection around her G-tube after she had
displaced it and was treated with antibiotics. He stated that cellulitis is a less severe
infection than fasciitis. Tr. at 212-13.
13

for that is what I’ve already said, which is at some point, the
tube was dislodged, almost certainly as a result of what this
unfortunate patient has done numerous times in the past to
herself, which is dislodged it.

Tr. at 253-54.

Further, Dr. Duszak testified that there was no evidence that R1 was harmed as a result of
the RN’s delegating the task of checking placement of the tube to the LPN after the RN
had replaced it. Tr. at 230. Dr. Duszak testified that waiting 10 minutes or 30 minutes
after the RN reinserted R1’s G-tube for the LPN to check the placement did not put R1 at
any risk of harm, because the tube was documented to be in the correct position, and no
tube feedings were administered during the interval. Tr. at 232-33. Dr. Duszak stated
that “one could conceivably conjecture harm” if the tube were in the wrong position (Tr.
at 233); however, he opined also that, even if the tube were in the wrong position, there
would have been no harm to R1 as long as nothing was administered through it that
would have created an infection risk. Tr. at 232. Dr. Duszak noted that his review of the
records showed that nothing was administered at all through R1’s G-tube. Tr. at 232.

With respect to documentation, Dr. Duszak stated that RN Calhoun’s failure to document
that she had replaced R1’s G-tube in the nurse’s notes did not harm R1 or put her at risk
of harm. Tr. at 258. He noted that the information was available that the treating
physician in the ER on February 12, 2008, knew that R1’s tube had been replaced, and, as
such, there was no impact upon R1’s clinical care. Tr. at 258-59.

As further support for its contention that R1’s G-tube was not improperly reinserted by
RN Calhoun, Petitioner also offered the testimony of Dr. Satinderjit Rick Gill, who
performed R1’s surgery. Dr. Gill is a general surgeon who practices primarily at Troy
Regional Medical Center. Tr. at 261.

Dr. Gill testified that, as stated in the SOD, he had an interview with Surveyor Bean on
May 1, 2008. Tr. at 262-63. Dr. Gill testified that certain quotes in the SOD that are
attributed to him by Surveyor Bean are not accurate. According to Dr. Gill, he did not
tell Surveyor Bean in the interview that R1 “had a G-Tube, PEG tube, stomach tube that
was improperly placed.” See Tr. at 263; see also CMS Ex. 1, at 11; P. Ex. 1, at 11; P. Ex.
40. Referring to his affidavit, Dr. Gill testified that the statement he gave in that affidavit
— “the tube was dislodged and in the subcutaneous tissues instead of the stomach” — is
correct. Tr. at 263; P. Ex. 40. Dr. Gill testified that he did not express any opinion or
conclusion regarding how or when the G-tube migrated to the subcutaneous tissue of
R1’s abdomen when he spoke to Surveyor Bean. Tr. at 263-64; P. Ex. 40.

Dr. Gill testified that the SOD misquotes him again where it states that he said that R1
“had been receiving her tube feeding for a number of days. This lead [sic] to the
necrotizing of the abdominal wall.” Tr. at 264; P. Ex. 40; see CMS Ex. 1. Dr. Gill
14

testified that “the tube feeding system is not a high pressure system and therefore, . . . the
tube feeds would not have ran [sic] for two days. So with that in mind, ... I could not
determine how long the tube had actually been in the subcutaneous tissue.” Tr. at 265.
Dr. Gill testified, moreover, that he did not know what caused the necrotizing fasciitis.
Tr. at 265, 281-82; see P. Exs. 33, 40.

Another instance where he was inaccurately quoted by Surveyor Bean, according to Dr.
Gill, is where the SOD quotes him as having stated, “[w]hen the tube was replaced by the
nurse at the nursing home, that was improperly done. In my opinion, the tube was
probably forced into the fascia. As a surgeon that is my opinion.” Tr. at 268-69; CMS
Ex. 1, at 12; P .Ex. 1, at 12; P. Ex. 40. Dr. Gill testified that he could not conclude
whether or not R1’s G-tube was reinserted correctly by the nurse based on his
assessment. Tr. at 269; P. Ex. 40. Dr. Gill noted that, by the time he examined R1, the
ER physician had removed her G-tube. Tr. at 268.

As stated above, on May 2, 2008, the day after his interview with Surveyor Bean, Dr. Gill
wrote a letter to Dr. Peter DiChiara, Petitioner’s Medical Director, stating his opinion
with respect to R1’s medical status.° Tr. at 264-65, 278-79; P. Ex. 33. In his letter, Dr.
Gill stated, among other things, “I can in no way determine the length of time that the G-
Tube had come out nor can I determine the exact etiology of the necrotizing fasciitis that
she had.” P. Ex. 33. Dr. Gill’s letter also stated that the tube feedings could not have run
for two days if the G-tube had been in the subcutaneous tissues, and that, when he
performed surgery, “there was not two to three liters of tube feeds in there, there was
purulent material and necrotic muscle and debris.” P. Ex. 33.

Dr. Gill stated that he did not contact Surveyor Bean to discuss his letter. Tr. at 279; see
Tr. at 69-70. As previously stated, Surveyor Bean did not contact Dr. Gill either, after he
received the letter.

With respect to the subject of tube feedings, I note that both Dr. Duszak and Dr. Gill
testified along similar lines. As previously stated, Dr. Duszak testified that his review of
the records showed that nothing had been administered at all through R1’s G-tube. Tr. at
232. Dr. Duszak testified that, based upon his personal review of R1’s abdominal and
pelvic CT scan (Tr. at 227, 246-47), he saw air in the soft tissues (called “subcutaneous
emphysema” (Tr. at 227, 247)) and x-ray dye from the diagnostic study, but “there was
no non-x-ray dye liquid to in any way indicate that there was any feed at all within the
anterior abdominal wall or within the subcutaneous tissues.” Tr. at 228, 232-33, 247-48.
Dr. Duszak’s testimony is consistent with that of Dr. Gill, for Dr. Gill testified that, when
e performed surgery on R1, he did not find “copious amounts of tube feeds” in the
subcutaneous tissue or in the abdominal abscess; instead, when he opened the abscess,

° Dr. Gill was uncertain as to how his letter was provided to the state survey agency. Tr.
at 264-65. Dr. Gill stated that he gave the letter to Dr. DiChiara, and sent a copy to the
‘ospital. Tr. at 264-65. He said that he “didn’t personally mail it in the mail” himself.
Tr. at 265.

15

“there was more so abscessed material, which was necrotic muscle and debris.” Tr. at
266, 280-81. Dr. Gill testified that, based on a reasonable degree of medical certainty, R1
would not have been able to have received two or three days of tube feedings in the
subcutaneous tissue, because “‘you couldn’t put that much tube feeds into a subcutaneous
space. It just couldn’t happen.” Tr. at 266.

I find that both Dr. Duszak and Dr. Gill were credible witnesses and gave convincing
reasons for their medical opinions. Although counsel for CMS cross-examined both Dr.
Duszak and Dr. Gill, cross-examination was ineffective and did not undermine their
credibility. I note, moreover, that CMS did not offer any physician expert testimony to
rebut the expert opinion of Dr. Duszak, or the informed medical opinion of Dr. Gill, nor
did CMS address their testimony in its post-hearing brief. I thus give greater weight to
Dr. Duszak’s and Dr. Gill’s testimony than that of CMS’s only witness, Surveyor Bean.
Although Surveyor Bean is a registered nurse and has had experience with G-tubes and
providing care to patients with G-tubes (Tr. at 20-22), I find his opinions and conclusions
regarding R1’s medical status to be unpersuasive in light of the record before me.

As Dr. Duszak opined, there is “overwhelming evidence” that R1, as she had done
several times in the past, most likely dislodged the G-tube herself a couple of days after it
had been appropriately reinserted on February 9, 2008, after R1 had displaced it that
morning. No dispute exists that the record shows that R1 had a history of pulling out her
G-tube, due to her altered mental status caused by Alzheimer’s disease and dementia. In
October 2005, she displaced her G-tube and went to the hospital, where she was
diagnosed with cellulitis at the PEG site and treated with IV antibiotics. P. Exs. 19, 20.
A hospital consultation report dated October 19, 2006, indicates that R1, who had
apparently been admitted the day before for altered mental status and dehydration, again
pulled out her G-tube, and a physician was called to replace it. P. Ex. 22; see P. Ex. 23.
In November 2007, R1’s G-tube was found to be out, and it was replaced. P. Ex. 26, at
27; CMS Ex. 9, at 62; see Tr. at 50, 75.

Thus, I cannot conclude that RN Calhoun failed to appropriately reinsert R1’s G-tube on
February 9, 2008, as CMS has alleged. In her testimony, RN Calhoun stated that she did
not meet any resistance when she reinserted the G-tube and that R1 did not display any
signs or symptoms of discomfort during the reinsertion. Tr. at 14. LPN Ward and CNA
Jones also testified that R1 did not display any discomfort or signs of pain when Nurse
Calhoun reinserted the G-tube. Tr. 150, 173-74. Although RN Calhoun did not herself
verify placement of the G-tube, LPN Ward testified that she verified placement of the G-
tube through a method called auscultation and documented that she performed this task
on R1’s MAR. P. Ex. 29; CMS Ex. 9, at 113, 114. Also, no question exists that the
nurse’s notes contain documentation that Petitioner’s staff checked the placement of R1’s
G-tube on February 10 and 11, 2008, and indicated that R1’s G-tube was checked, noted
to be patent, and no residual was noted. P. Ex. 28. What the record also indicates, based
on the testimony of Dr. Duszak and Dr. Gill, is that R1 had “necrotic debris and dead
tissue” but did not have “copious amounts of tube feeds” within the subcutaneous tissue
16

or in her abdominal abscess at the time of her surgery. Tr. at 266, 281. This is further
proof that undermines CMS’s argument that R1 received tube feedings “via the ill placed
tube for three days” before she was admitted to the hospital. CMS Brief at 18.

I find that CMS misrepresents the facts when it states in its post-hearing brief that “[R1]
had to endure a life threatening surgery to remove the improperly placed G-tube, as well
as to remove the dead skin tissue caused by the improper placement.” CMS Brief at 18.
R1 did undergo emergency surgery; however, its purpose was not “to remove the
improperly placed G-tube.” As discussed above, Dr. Gill testified that the G-tube had
already been removed by the ER physician by the time he examined R1.

Moreover, CMS has produced no evidence to support its claim that improper G-tube
placement caused R1’s necrotizing fasciitis. Dr. Duszak testified that, in his professional
opinion and to a reasonable degree of medical certainty, R1’s necrotizing fasciitis was not
caused by an improper placement of the G-tube by the RN on February 9, 2008. Dr.
Duszak stated that R1’s diagnoses of peripheral vascular disease and diabetes
predisposed her to a much higher risk of infection than the general population.
According to Dr. Duszak, patients with these diagnoses have immune systems that are
“dramatically compromised,” and, with them, “one will not uncommonly see infections,
number one; more commonly, and number two, when they progress, those infections will
often progress in what is really almost a fulminant course . . . than somebody who has an
intact immune system.” Tr. at 211. Dr. Duszak also testified that, “at some point on the
12" [of February], things went bad.” Dr. Duszak went on to state that R1 most likely
dislodged her G-tube herself and that a “small amount of tube feeds probably got
administered into the anterior abdominal wall, contributed to the fulminant fasciitis,”
probably “just hours” before she went to the ER. Tr. at 254. R1’s surgeon, Dr. Gill,
testified that there was “no way” for him to determine what caused R1’s necrotizing
fasciitis. Dr. Gill testified that an abscess can develop anywhere, it can be “caused by a
multitude of things,” and that an infection can travel to a different place in the body. Tr.
at 281-82.

It is clear that Rl was much more susceptible to infections due to her highly
compromised immune system and that, once an infection appeared anywhere in her body,
there was a high probability that it would rapidly develop and worsen. Based on Dr.
Duszak’s and Dr. Gill’s credible testimony, I find that, whatever the cause of R1’s
necrotizing fasciitis, CMS has not shown that it resulted from any deficient care on the
part of Petitioner’s staff.

On the issue of staff training, CMS argues that Petitioner failed to provide proper training
to its nurses on the reinsertion of G-tubes. CMS Ex. 1, at 2; P. Ex. 1, at 2. In its post-
hearing brief, Petitioner asserts that 42 C.F.R. § 483.25 “makes no mention of how or
where the nursing staff should receive their training. The regulation only requires that
the nurses are trained and that they perform their duties appropriately.” P. Brief at 12. I
17

agree with Petitioner. The thrust of 42 C.F.R. § 483.25 is on whether a resident received
the necessary care and services from facility staff. It does not set forth any explicit
requirements regarding how or where nursing staff receive training.

I find that Petitioner has demonstrated that its nursing staff had the proper education and
training in G-tubes. At the hearing, RN Calhoun testified that, before becoming an RN,
she had been an LPN for 14 years. She testified that both her LPN and RN nursing
education included training on reinsertion of G-tubes. Tr. at 135-36. According to RN
Calhoun, as part of her LPN training, she had to perform the procedure for reinsertion of
a G-tube before a clinical instructor. Tr. at 135-36. RN Calhoun stated that, during her
RN training, she studied the anatomy and physiology of the stomach and learned about
G-tubes. She also demonstrated reinsertion of a G-tube before a clinical instructor. Tr. at
136. RN Calhoun stated that she received additional training regarding reinsertion of a
G-tube when she previously worked at another long-term facility. She again
demonstrated the skill in a clinical setting. Tr. at 136-37; P. Ex. 38. Further, RN
Calhoun testified that she has cared for residents with tube feedings on a regular basis,
and, during her RN career, she has inserted G-tubes on a regular basis. Tr. at 137.

I have no reason to doubt RN Calhoun’s training on the reinsertion of G-tubes. It is
evident that RN Calhoun has taken coursework and received clinical training in the
reinsertion of G-tubes and had experience performing this procedure in the long-term
care setting. While Petitioner may not have provided any “competency courses” on G-
tube insertion to its nurses, as the SOD alleged, I do not consider this to be a relevant
issue. I note that the record contains a document titled “Gastric Tube Insertion
Certification,” dated September 27, 2006, which indicates that RN Calhoun had
successfully demonstrated competence in the procedure of G-tube insertion. As such, she
was fully certified to perform this procedure at the Cullman Health and Rehab facility
(her former employer).’ P. Ex. 38; see Tr. at 136. RN Calhoun and her supervisor at the
time signed the document. P. Ex. 38. Furthermore, given the fact that I have concluded
that the evidence does not support a finding that RN Calhoun improperly reinserted R1’s
G-tube on February 9, 2008, this only reinforces a finding that RN Calhoun was qualified
to perform this procedure.

There is also little evidence in the record to suggest that LPNs Ward and Mote did not
have proper training on the verification of the placement of G-tubes. LPN Ward testified
that, at LPN school, she received training on verifying G-tube placement, which
consisted of academic studying and performing it in front of a clinical supervisor. Tr. at
151. She stated that she checks the placement of G-tubes on residents approximately 25
to 30 times a week and uses the auscultation method. Tr. at 150-52, 220-21. LPN Mote
testified that she had received training on the verification of G-tube placement “over the

7 The certification document lists the following three areas in which competency is
required: “Demonstrates understanding of G-tube placement . .. Demonstrates skill in
checking G-tube for correct placement ... Demonstrates knowledge of correct
calculation of diet and fluids.” P. Ex. 38.
18

years” and that, in LPN school, her training consisted of “[w]atching films and watching
one being put in and being watched” by a nursing instructor when she performed this
skill. Tr. 184. LPN Mote testified that she uses the auscultation technique and checks
the placement of G-tubes on residents at least 20 times a week. Tr. at 185.

As discussed above, on February 9, 2008, LPN Ward verified the placement of R1’s G-
tube using the auscultation method after RN Calhoun reinserted it and documented the
verification on R1’s MAR. In the days following the reinsertion, there is documentation
that Petitioner’s staff verified the placement of the G-tube. On February 10, 2008, in a
nurse’s note, LPN Mote stated that R1’s G-tube was “patent & intact. [No] residual
noted.” P. Ex. 26, at 31; P. Ex 28. In another nurse’s note dated February 11, 2008, LPN
Mote wrote that R1 was “complaining [with] G tube site hurting & stomach hurting.
Placement of G tube checked. [No] residual noted.” P. Ex. 26, at 32; P. Ex. 28, at 2.
LPN Mote testified that she verified placement using auscultation and documented this
on the MAR with her initials. Tr. at 188; P. Ex. 29; CMS Ex. 9, at 113, 114. I note that
CMS does not dispute that Ms. Ward and Ms. Mote initialed the MAR to indicate that
they had checked R1’s G-tube placement. Tr. at 161, 162, 189. Based on their education
and experience, it is reasonable to infer that both LPNs Ward and Mote were properly
trained to check the placement of R1’s G-tube.

V. Conclusion

For the reasons discussed above, I conclude that Petitioner established by a
preponderance of the evidence that it complied substantially with 42 C.F.R. § 483.25.
Further, Petitioner did not manifest any immediate jeopardy level failures to comply with
this participation requirement. CMS therefore had no basis for imposing a per instance
CMP of $6,000 against Petitioner.

/s/
Alfonso J. Montafio
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Life Care Center of Leominster
(CCN: 22-5038),

Petitioner
Vv.

Centers for Medicare and Medicaid Services.
Docket No. C-09-139
Decision No. CR2207
Date: August 10, 2010

DECISION

I find that Life Care Center of Leominster (Petitioner) failed to comply substantially with
42 C.F.R. § 483.25(h)(2) by failing to provide a cognitively-impaired, 89-year old
resident (Resident #1) with adequate supervision to prevent the choking accident that
occurred on August 11, 2008. I therefore sustain the Centers for Medicare and Medicaid
Services’ (CMS) imposition of a civil money penalty (CMP) of $300 for one day of non-

compliance.

I. Background

Petitioner participates in the Medicare and Medicaid programs pursuant to sections 1819,
1919, and 1866 of the Social Security Act (Act) and by its implementing regulations at 42
C.F.R. Parts 483 and 488. Its right to a hearing in this case is governed by regulations at

42 C.F.R. Part 498.

On August 20, 2008, the Massachusetts Department of Public Health, Division of Health
Care Quality (the state survey agency) conducted a complaint survey and found Petitioner
was not in substantial compliance with Tag F323 — accidents and supervision under the
quality of care regulation at 42 C.F.R. § 483.25(h)(2). CMS Ex. 1. Based on the survey
finding, CMS imposed a $300 CMP for one day of substantial noncompliance. October
30, 2008 Letter from CMS.

I was assigned this case for hearing and decision. I conducted a hearing on December 3,
2009, and the parties received a transcript (Tr.) of the proceeding. CMS offered, and I
admitted CMS Exhibits (CMS Exs.) 1-11. Tr. at 8 and 30. Petitioner offered, and I
admitted Petitioner Exhibits (P. Exs.) 1-29. Tr. at 9. The parties submitted posthearing
briefs and reply briefs.

II. Applicable Law

The regulatory requirements for long-term care facilities that participate in the Medicare
and Medicaid programs are set forth at 42 C.F.R. Part 483. Facility compliance with the
participation requirements is determined through a survey and certification process.
Sections 1819 and 1919 of the Act; 42 C.F.R. Parts 483, 488, and 498. This process is
performed on behalf of the Secretary of the Department of Health and Human Services
(HHS) and CMS by state survey agencies.

Under Part 488, CMS may impose a CMP against a facility that is not complying
substantially with participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430.
The penalty may start accruing as early as the date that the facility was first out of
compliance and runs until the date substantial compliance is achieved or the provider
agreement is terminated.

“Deficiency” is defined as a facility’s “failure to meet a participation requirement
specified in the Act” or in 42 C.F.R. Part 483. 42 C.F.R. § 488.301. The term
“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.” Jd. “Noncompliance” means
“any deficiency that causes a facility to not be in substantial compliance.” Jd.
“Immediate jeopardy” means “a situation in which the provider’s noncompliance . . . has
caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” Jd.

The regulations specify that a CMP that is imposed against a facility on a per-day basis
will fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The
upper range of CMP, of from $3,050 per day to $10,000 per day, is reserved for
deficiencies that constitute 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). The
lower range of CMP, from $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). There is only a single range of $1,000 to $10,000 for a per-instance
CMP that applies whether or not immediate jeopardy is present. 42 C.F.R.
§§ 488.408(d)(1)(iv), 488.438(a)(2).

The Act and regulations make a hearing before an administrative law judge (ALJ)
available to a long-term care facility against which CMS has determined to impose a
CMP. Act § 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). The hearing before an
ALJ is a de novo proceeding. Residence at Salem Woods, DAB No. 2052 (2006); Cal
Turner Extended Care Pavilion, DAB No. 2030 (2006); Emerald Oaks, DAB No. 1800,
at 11 (2001); Beechwood Sanitarium, DAB No. 1906 (2004); Anesthesiologists Affiliated,
et. al, 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); see also 42 C.F.R. §§ 488.330(e), 498.3. However, the choice of
remedies or the factors CMS considered when choosing remedies are not subject to
review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity
level of noncompliance that CMS found if a successful challenge would affect the
amount of the CMP that CMS could collect or impact the facility’s nurse aide training
program. 42 C.F.R. §§ 498.3(b)(14), (d)(10)(i). CMS’s determination as to the level of
noncompliance “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2).
This includes CMS’s findings of immediate jeopardy. Woodstock Care Ctr., DAB No.
1726, at 9, 39 (2000), aff'd, Woodstock Care Ctr v. U.S. Dept. of Health & Human Servs.,
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 governed by 42 C.F.R. § 488.438(e).

III. Issue, Findings of Fact, and Conclusions of Law

A. Issue
The sole issue in this case is whether Petitioner failed to comply substantially with the
requirements that the resident environment remain as free of accident hazards as is
possible and that each resident receives adequate supervision and assistance devices to

prevent accidents. 42 C.F.R. § 483.25(h)(2).

The only remedy imposed is a $300 per day CMP for one day of substantial
noncompliance. Petitioner has not argued that the CMP imposed is unreasonable.

' Such a challenge only applies where CMS has imposed a per-day CMP within the
upper range. No such challenge is available if a per instance CMP is imposed.
B. Findings of Fact and Conclusions of Law

I make the following findings of fact and conclusions of law (Findings), set forth below
as separate headings in bold and italics, to support my decision in this case.”

1. Petitioner was not in substantial compliance with the requirements of 42
CF.R. § 483.25(h)(2).

This case involves a single deficiency. Specifically, CMS maintains that Petitioner
violated section 483.25(h)(2) by failing to provide a cognitively-impaired, 89-year old
resident, Resident #1, with adequate supervision to prevent the choking accident that
resulted in Resident #1’s death.

Resident #1 was admitted to the facility in April 2007, suffering from various medical
and cognitive impairments, including swallowing disorders and dementia with delusions.
P. Br. at 4; CMS Br. at 2. Resident #1 had difficulty chewing and swallowing, and he
required a purced diet with thin liquids. His care plans further provided that he be
supervised at meals and monitored for signs and symptoms of choking or aspiration.
CMS Exs. 1, 2, 4. Indeed, a few weeks before the subject incident, Resident #1 was re-
assessed and again found to be at risk for choking and aspiration. The evaluation stated
that Resident #1 was extremely impulsive during the meal with an increased rate of
intake. Resident #1 took large bites of food and refused to open his mouth to be checked
for pocketing of the food. As a result, the evaluation concluded that Resident #1 should
remain on a puréed diet with thin liquids and with aspiration precautions taken. CMS Ex.
1; CMS Ex. 4.

There also is no dispute that Resident #1 was a food scavenger. CMS Ex. 11, at 8, 10; P.
Ex. 16, at 4, 5. Staff was aware that Resident #1 would grab solid food within his reach
from other people as he maneuvered his wheelchair through the facility. He would grab
food from the food carts or from other residents/ trays, both in the dining room and in the
hallways of the facility. CMS Ex. 1; CMS Ex. 11, at 8-10, 14; CMS Ex. 7 (The Health
Alliance Hospital Report, dated August 11, 2008, stated “[t]he staff told [ER] nurse here
by telephone later that the patient was known to take solid food from other people as he
maneuvered with his wheelchair, though he was required to be on a puréed diet

> Thave reviewed the entire record, including all the exhibits and testimony. As I am not
bound by the rules of evidence, I may admit evidence and determine later, upon a review
of the record as a whole, what weight, if any, I should accord that evidence or testimony.
To the extent that any contention, evidence, or testimony is not explicitly addressed or
mentioned, it is not because I have not considered the contentions. Rather, it is because I
find that the contentions were not supported by the weight of the evidence or by credible
evidence or testimony.
himself.”). Resident #1 was known to become agitated and impulsive when agitated.
When this occurred, he was likely to scavenge food and to engage in other behaviors that
were a danger to him and to others, as he self-propelled through the facility. Tr. at 112-
13, 130, 137-38, 173.

No dispute exists that previous to the incident on August 11, 2008, there were two
locumented instances on June 3 and June 4, 2008 of Resident #1 scavenging food. P. Ex.
16, at 4-5; CMS Ex. 2, at 16; Tr. at 131-35. There also were increasing episodes of
agitation. CMS Ex. 3, at 4-6. Asa result, on June 24, 2008, Petitioner revised Resident
#1’s care plan to address his increased agitation and to protect him from these episodes.
The care plan added a requirement for staff to “shadow resident as needed to prevent
resident from encountering hazards as he self propels in w/c.” > CMS Ex. 2, at 7; P. Ex.
12, at 5. Therefore, when Resident #1 became agitated, the nursing staff, which was
supposedly aware of the various hazards to Resident #1 and others, was to keep him in
their line of sight “until the agitation had gone” and until the staff knew he would not
cause harm to himself or anybody else. Tr. at 150, 151, 180. Petitioner does not dispute
this. P. Br. at 8.

On August 11, 2008, a short time before 5:30 p.m., Resident #1 and his wife were seated
in wheelchairs in the lobby area, adjacent to the main dining room, waiting for dinner. P.
Br. at 8; CMS Br. at 3; P. Ex. 26, CMS. Ex. 11, at 2; Tr. at 113. Resident #1 and his wife
argued, and Resident #1 became agitated. P. Br. at 8; CMS Br. at 3. When the meal
truck arrived at the dining room, CNA Peterson escorted the wife into the dining room.
Because he was agitated, the CNA that was supervising Resident #1 and his wife stated in
the Nurses Notes—

Prior to dinner in the main dining room [Resident #1] was agitated. So to avoid
anything further we aloud [sic] him to rome [sic].

Written statement of CNA S. Peterson, P. Ex. 27, at 3. She testified that usually when he
would become agitated, the staff would “just let him go propel and do his own thing until
he would calm down.” Tr. at 178. Although no documentation exists of this, CNA
Peterson claims that after she brought the wife into the dining room, she remained in the
doorway of the dining room and lobby for a few minutes until Resident #1 started to

> The revised care plan addressing Resident #1’s Mood/Behavior identified his
mood/behavior problems as “increased agitation, AEB, striking out at staff, yelling in
corridor, striking railings as he self propels in his w/c, attempting to grab [illegible] at
other residents.” P. Ex. 12, at 5. CMS Counsel asked the Director of Nursing (DON)
what AEB meant, but she did not know. Tr. 139, 140. I would expect a DON to be
familiar with abbreviations and terms used in the Care Plans developed by her staff, since
the DON is ultimately responsible for supervising and advising nursing staff in the
facility. 42 C.F.R. § 483.30 and 483.30(b)(2).
propel toward the A wing.’ Tr. at 184. Resident #1 then left the lobby around 5:30 p.m.,
self-propelling in his wheelchair. While Petitioner’s brief claims that CNA Peterson
stayed with Resident #1 until he calmed down, no direct evidence exists that this is true
or that she watched for more than a minute. She returned to the dining room where she
was occupied with serving the evening meal to the residents. CMS Ex. 11, at 9. It is also
undisputed that Resident #1 was last seen propelling himself in his wheelchair down
toward the A Wing and that his movements and activities for the next 10 to 15 minutes
are unknown.

During this period, two or three food carts were in the A wing corridor and at least one of
the carts had an open door within reach at wheelchair level. P. Exs. 25 and 26; CMS Ex.
1, at 6; CMS Ex. 3, at 13; Tr. at 54, 56, 85, 94, and 157. The next documented sighting
of Resident #1 occurred between 5:40 and 5:45 p.m. when Henry Hotin, the facility’s
physical therapist, who had been doing paperwork at the A wing nurses’ station, observed
Resident #1 coming towards the nurses’ station from the end of the A wing corridor
furthest away from the front lobby and the dining room. CMS Ex. 1, at 4; CMS Ex. 6, at
2; CMS Ex. 11, at 2; Tr. at 53. Mr. Hotin observed that Resident #1 had a chicken
sandwich in his hand. Mr. Hotin was unaware of Resident #1’s diet restrictions, and,
after nodding to the resident, he returned to his paperwork. CMS Ex. 6, at 2; Tr. at 191.
Shortly thereafter, an unidentified staff member parked the resident in his wheelchair up
against the wall across from the nurses’ station. CMS Ex. 6, at 2; CMS Ex. 11, at 12; P.
Ex. 26. Mr. Hotin stood up from where he was sitting, as he was getting tired. Tr. at

191. He then looked over and saw that Resident #1 looked distressed. Tr. at 191. He
was not sure what was wrong and asked “[a]re you alright?” Jd. When Resident #1 did
not respond, Mr. Hotin realized Resident #1 was choking and called out to Nurse Durrett,
an LPN who was behind the nurses’ station. Tr. at 192; CMS Ex. 6. Mr. Hotin
performed the Heimlich maneuver a couple of times with the resident in the wheelchair,
while Nurse Durrett brought over the crash cart and tried to suction the food out of his

* CNA Peterson mentioned during the hearing for the first time that she remained with
Resident #1 for a few minutes in the lobby area, “until she realized he had calmed down”
and then she went into the dining room. Tr. at 180-81. However, when Resident #1
propelled himself towards the A wing corridor, his back would have been facing CNA
Peterson, and it would be difficult for her to assess whether he had calmed down. CMS
Ex. 11, at 2; Tr. at 183. I do not find her testimony credible; first, she describes that she
stayed with Resident #1 for a “few minutes” and then she later claims she remained with

im for as long as five to seven minutes. Jd. She also indicated that keeping an eye on
Resident #1 did not require her to stop or leave her other duties. Tr. at 179. Iam not sure

ow she could attend to her other duties and still observe the resident. She also testified
that, if she knew Resident #1 was agitated, she would notify the other staff so they could
‘eep an eye on him. Tr. at 179. But no indication exists that she notified anyone on the
evening of August 11.

mouth and to perform first aid. /d. Nurse Durrett called a code blue and 911. While
some food was removed, Resident #1 still had minimal breath sounds. CMS Ex. 6. The
fire department responded within minutes, and Resident #1 was taken to the hospital
where he was pronounced dead due to fatal cardiopulmonary arrest associated with solid
food aspiration. CMS Ex. 7.

I find CMS’s arguments to be persuasive and supported by the weight of the evidence. I
am not persuaded by Petitioner’s arguments and assertions that it adequately protected
Resident #1. The applicable regulation has been the subject of much litigation.° It
requires a facility to take all reasonable measures to protect its residents from accident
hazards that are known or that are foreseeable. In determining whether the supervision
the facility provided was adequate, I must first look at whether Petitioner provided
supervision in accordance with the resident’s assessment and plan of care. My inquiry
need go no further. Petitioner recognized that Resident #1 was becoming increasingly
agitated and aggressive and that his agitation coupled with his dementia caused impulsive
behavior, which put him and others at risk. As a result, on June 24, 2008, Petitioner
amended Resident #1’s plan of care to respond to his agitation and to protect Resident #1
from the hazards resulting from this behavior. The care plan required that, when
Resident #1 became agitated, staff give him wide birth in his personal space (noting
specifically not to attempt to engage the resident by standing directly in from of him), but
to shadow the resident to prevent him from encountering hazards. Petitioner clearly did
not do that. The evidence establishes that Resident #1 became agitated, and, while CNA
Peterson stayed with him for a few minutes, she returned to the dining room when he
moved away from her in his wheelchair and he propelled down the corridor. Petitioner
claims Resident #1was “apparently calmer” when he wheeled himself away, but there is
no indication that she or anyone else performed any real assessment. Rather, she had
another pressing concern—she was needed in the dining room to assist with the dinner
hour—so she returned to the dining room. She did not shadow Resident #1; she did not

* See Koester Pavilion, DAB No. 1750, at 24 (noting the regulation does not impose
strict liability of unforeseeable mishaps, but requires a facility “to do everything in its
power to prevent accidents”); Windsor Health Care Ctr., DAB No. 1902, at 5 (2003)
(holding a facility may “choose the methods it uses to prevent accidents, but the chosen
methods must constitute an ‘adequate’ level of supervision under all the circumstances”);
Briarwood Nursing Ctr., DAB No. 2115, at 11 (2007) (finding the relevant inquiry is
“whether the facility took all reasonable steps to ensure that a resident receives
supervision and assistance devices that meet his or her assessed needs and mitigate
foreseeable risks of harm from accidents”); and Burton Health Care Ctr., DAB No. 2051,
at 14 (2006) (stating that in determining whether the supervision a facility provides was
adequate, the Board looks “first to whether the facility provided supervision in
accordance with the resident’s . . . plan of care,” and a facility’s failure to “provide the
type of supervision that it had determined was required to meet the resident’s needs”
supports the finding of a deficiency under section 483.25(h)(2)).
make any other staff aware of his agitation or ask that any other staff shadow him down
the hall. Her only statement immediately after the event was that Resident #1 “was
agitated so to avoid anything further we aloud [sic] him to rome [sic].”” CMS Ex. 3, at 14.
There is no dispute that from the time he began to propel down the corridor until some 10
to 15 minutes later, when Henry Hotin looked up from his paperwork at the nurses’
station, no one was supervising or shadowing this resident as his care plan required.
There is also no dispute that during the time Resident #1 was left to roam the hallway
unsupervised, the staff were busy as it was the dinner hour. P. Ex. 26. Giving Resident
#1 wide berth does not mean to not provide supervision. Petitioner knew this. Tr. at 152-
56. An intervention established to protect a resident from potential harm is useless,
unless it is implemented. That failure is precisely what occurred here. No one monitored
Resident #1 even from a reasonable distance. Ifa staff member had shadowed him, that
staff member would have seen him reach for and grab a sandwich from the food cart and
could have taken the sandwich from him. Given the previous incidents with this resident
and food, which prompted the new intervention in his care plan, a choking accident was
indeed foreseeable.

IV. Conclusion

Based on my review of all of the evidence and testimony in this case, I sustain CMS’s
finding of noncompliance and its imposition of a CMP of $300 for one day of substantial
noncompliance.

/s/
Alfonso J. Montafio
Administrative Law Judge