Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Pigeon Forge Care and Rehab Center
(CCN: 44-5382),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-13-294
Decision Number. CR3909

Date: May 28, 2015

DECISION

Pigeon Forge Care & Rehab Center (Petitioner or facility) is a long-term care facility
located in Pigeon Forge, Tennessee, which participates in the Medicare program. Based
on findings of a survey completed by the East Tennessee Regional Office of Health Care
Facilities (state agency) on November 8, 2012, the Centers for Medicare & Medicaid
Services (CMS) determined that Petitioner was not in substantial compliance with
Medicare participation requirements. Due to this noncompliance, CMS imposed on
Petitioner a civil money penalty (CMP) of $3,550 per day from July 18 through October
30, 2012, and a CMP of $200 per day from October 31 through December 1, 2012, the
date the state agency determined that Petitioner returned to substantial compliance.
Based on the record as a whole, I conclude that Petitioner has shown that it was in
substantial compliance with Medicare participation requirements on the dates for which
CMS imposed the CMP. Therefore, I reverse CMS’s determination to impose a CMP.

I. Background and Procedural History

The Social Security Act (Act) sets forth requirements that nursing facilities must meet to
participate in the Medicare program and authorizes the Secretary of the United States
Department of Health and Human Services (Secretary) to promulgate regulations
implementing those statutory provisions. Act § 1819 (42 U.S.C. § 1395i-3). The
Secretary’s regulations are found at 42 C.F.R. Parts 483 and 488. To participate in the
Medicare program, a 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 or safety than the potential for causing minimal harm.”
42 CFR. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine
whether skilled nursing facilities are in substantial compliance. Act § 1864(a) (42 U.S.C.
§ 1395aa(a)); 42 C.F.R. § 488.10. Each facility must be surveyed once every 15 months,
or more often if necessary, to ensure that it corrects identified deficiencies. Act

§ 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.

The Act also authorizes the Secretary to impose enforcement remedies against a long-
term care facility that does not comply with the federal participation requirements. Act
§ 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). 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. Among other enforcement remedies, CMS
may impose a per-day CMP for the number of days a facility is not in substantial
compliance or a per-instance CMP for each instance of the facility’s noncompliance.

42 C.F.R. § 488.430(a). A per day CMP, which CMS imposed in this case, may range
from either $50 to $3,000 per day for less serious noncompliance, or $3,050 to $10,000
per day for more serious noncompliance that poses immediate jeopardy to the health and
safety of residents. 42 C.F.R. § 488.438(a)(2). “Immediate jeopardy” exists when “the
provider’s noncompliance with one or more requirements of participation has caused, or
is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R.

§ 488.301.

If CMS imposes a CMP based on a noncompliance determination, then the facility may
request a hearing before an administrative law judge to challenge the noncompliance
finding and enforcement remedy. Act §§ 1128(c)(2) (42 U.S.C. § 1320a-7a(c)(2)),
1819(h)(2)(B)(ii) (42 U.S.C. § 1395i(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g),
488.434(a)(2)(viii), 498.3(b)(13).

On November 8, 2012, surveyors from the state agency completed an abbreviated/partial
extended survey at the facility. On November 16, 2012, CMS notified Petitioner that
CMS found Petitioner out of substantial compliance with the following five participation
requirements based on the state agency’s survey results as documented on Form CMS-
2567 Statement of Deficiencies (CMS Exhibit (Ex.) 1):
42 C.F.R. § 483.10(b)(11) (Tag F157, Physician Notification) at a
scope and severity level of D (no actual harm with the potential for
more than minimal harm);

42 C.F.R. § 483.20(b)(1) (Tag F272, Comprehensive Assessments)
at a scope and severity level of J (immediate jeopardy);

42 C.F.R. § 483.25(h) (Tag F323, Accidents) at a scope and severity
level of J;

42 C.F.R. § 483.75 (Tag F490, Administration) at a scope and
severity level of J; and

42 C.F.R. § 483.75(0)(1) (Tag F520, Quality Assurance) at a scope
and severity level of J.

CMS Exs. 1, 2. CMS also notified Petitioner that it was imposing a CMP of
$3,550 per day from July 18 through October 30, 2012, and $200 per day effective
October 31, 2012 until Petitioner achieved substantial compliance or CMS
terminated its Medicare participation. CMS Ex. 2 at 2. On December 4, 2012, the
state agency conducted a revisit which found Petitioner in substantial compliance
as of December 1, 2012. CMS Ex. 5. The total CMP imposed is $378,950. CMS
Ex. 8 at 1.

On January 14, 2013, Petitioner timely requested a hearing to contest CMS’s findings of
noncompliance and CMP. The case was assigned to me for hearing and decision. On
January 18, 2013, I issued an Acknowledgment and Initial Pre-Hearing Order
establishing a briefing schedule.

In accordance with that schedule, on May 2, 2013, CMS submitted a pre-hearing brief
(CMS Br.), accompanied by 21 exhibits (CMS Exs. 1 — 21). CMS offered the written
direct testimony of one proposed witness, state agency surveyor Cindy Wilson, RN
(Surveyor Wilson), which was marked as CMS Ex. 21.

On June 6, 2012, Petitioner submitted a pre-hearing brief (P. Br.), accompanied by 16
exhibits (P. Exs. 1 — 16). Petitioner offered the written direct testimony of seven
proposed witnesses: Keith Boyce, NHA (P. Ex. 1), Petitioner’s Administrator (NHA
Boyce); Zhanna Efflandt, RN (P. Ex. 2), an RN employed by Petitioner (RN Efflandt);
Vicki Chambers Freshour, RN (P. Ex. 3), an RN employed by Petitioner as a restorative
nurse (RN Freshour); Robin Jones, RN (P. Ex. 4), Petitioner’s Director of Nursing (DON
Jones); Melinda Little, LPN (P. Ex. 5), an LPN employed by Petitioner (LPN Little);
Annette Wenzler, RN (P. Ex. 6), the Chief Nurse Executive for Signature Healthcare,
LLC, Petitioner’s owner (RN Wenzler); and Michael L. Williams, LPTA (CMS Ex. 7), a
licensed physical therapist assistant performing physical therapy services at Petitioner
(LPTA Williams).'

Following the pre-hearing exchanges, I directed my staff attorney to contact the parties to
determine whether they intended to cross-examine the opposing party’s witnesses and to
ask whether they objected to the other party’s exhibits. She did so, and a series of
electronic mail communications began on June 12, 2014 and culminated on June 23,
2014. On June 13, 2014, CMS stated that it did not intend to cross-examine Petitioner’s
witnesses, but that it objected to P. Ex. 12, described as “Photographs of Resident 2 and
Side Rail” and to parts of P. Exs. 1 and 6 that referenced the photographs.” Petitioner
responded on June 16, 2014, stating that it intended to cross-examine CMS’s proposed
witness, Surveyor Wilson, who it noted was now employed by a facility owned by
Petitioner’s parent company. Petitioner also stated that it did not object to CMS’s
exhibits and it offered a response to CMS’s objection to its exhibits, which I discuss
below.

Apparently in light of Surveyor Wilson’s employment with a facility owned by
Petitioner’s parent company, on June 23, 2014, CMS informed me that it had decided to
withdraw her testimony, stating: “CMS will not reference Ms. Wilson’s written
testimony as evidence in future pleadings in this case.” On June 23, 2014, I directed my
staff attorney to advise the parties that, as CMS had withdrawn the only witness who
would be subject to cross-examination, I would not hold an oral hearing and would
instead decide the case on the written record. I offered the parties the opportunity to file
final briefs. CMS and Petitioner both filed final briefs (CMS Final Br. and P. Final Br.,
respectively).

II. Evidentiary Rulings and Decision on the Record

In the absence of objection, I admit CMS Exs. | — 20.3 As noted above, CMS withdrew
CMS Ex. 21.

' Petitioner filed a motion for partial summary judgment regarding the duration of the
CMP in this case. CMS responded to the motion for partial summary judgment. Because
this decision is favorable to Petitioner, Petitioner’s motion is moot.

> CMS also asked for clarification that the person providing physical therapy services to
Resident 2 in July 2012, described in RN Jones’ testimony (P. Ex. 4 at 2) as “Joe
Williams,” was the “Michael L. Williams” whose written direct testimony Petitioner
offered as P. Ex. 7. On June 16, 2014, Petitioner’s counsel clarified that Joe Williams
and Michael L. Williams are the same individual.

* In its briefing, CMS references Surveyor Wilson’s surveyor notes (CMS Ex. 16). I rely
on CMS Ex. 16 only to the extent the notes are supported by other evidence of record
CMS objects to P. Ex. 12, a two-page exhibit that Petitioner offers as “[p]hotographs of
Resident 2 and side rail.” The photographs depict, at page 1, a woman sitting on the side
of a bed with her left forearm coming through the upper middle of a side rail, and another
individual who is helping to support her (P. Ex. 12 at 1), and a photograph of her arm
only (P. Ex. 12 at 2). CMS asserts that: 1) the photographs were not taken at the time of
the July 18, 2012 incident which is the subject of this appeal; 2) the individuals depicted
are not identified; and 3) the position of the elderly woman is inconsistent with the
descriptions of the incident contained in other evidence (P. Ex. 3 at 3; P. Ex. 5 at 2) that
state the resident was “half out of the bed.” CMS argues that it does not believe the
photographs are “true and accurate” images of the circumstances as they existed at the
time of the incident involving Resident 2 on July 18, 2012. CMS also objects to P. Ex. 1
(the testimony of NHA Boyce) which references P. Ex. 12 as a “true and accurate
depiction[].” CMS states that NHA Boyce was not present at the time of the incident and
did not witness it. CMS also objects to RN Wenzler’s testimony referencing P. Ex. 12.

Petitioner responds that NHA Boyce’s testimony clearly identifies the resident on the bed
as Resident 2. Petitioner states that the purpose of offering the photograph is to show that
Resident 2’s arm could not possibly have been entrapped in her bed rail, as Surveyor
Wilson claimed, and that the bed rail is appropriate for the purpose for which it was used.
Petitioner argues that any differences between the photographs and the survey report
should go to the photographs’ evidentiary weight, not their admissibility. Petitioner also
asserts that CMS misstates NHA Boyce’s testimony, which is that Resident 2’s arm looks
in the two photographs the way it did in July 2012, and that the bed rail in the second
photograph is like the one Resident 2 used in July 2012. NHA Boyce’s testimony in this
regard is found at P. Ex. | at 1 § 8 and is that:

The photographs that are included as exhibits to Pigeon
Forge’s Prehearing Brief in this case are true and accurate
depictions of (1) Resident 2’s left arm as it was in July of
2012, (2) her left arm inside the quarter rail that was in place
in July of 2012, and (3) the halo ring that was used to replace
the quarter rail in August 2012.

I note that the picture of the halo ring he references is found at P. Ex. 14. CMS did not
object to admission of the photograph of the halo ring.

because CMS withdrew Surveyor Wilson as a witness and Petitioner was precluded from
cross-examining her. I note also that there is now no witness testimony authenticating
the findings of the November 8, 2012 survey set forth in the November 8, 2012 Statement
of Deficiencies (CMS Ex. 1). I rely on the Statement of Deficiencies, but only to the
extent its findings are not rebutted by other evidence of record.
I agree with Petitioner that CMS’s objections go to the evidentiary weight of P. Ex. 12
and NHA Boyce’s and RN Wenzler’s testimony, and not to the admissibility of the
exhibit itself. Accordingly, I overrule CMS’s objection.

In the absence of any other objection, I admit P. Exs. 1 — 16.

My Order advised the parties that they must submit written direct testimony for each
proposed witness and that I would only schedule an in-person hearing if a party requested
an opportunity to cross-examine a proposed witness. As noted above, CMS did not ask
to cross-examine any of Petitioner’s witness. CMS withdrew the written direct testimony
of its only proposed witness. Thus, there are no witnesses subject to cross-examination
and nothing for me to hear. Accordingly, I issue this decision on the written record. The
written record in this case includes the parties’ briefs and the admitted exhibits, which
include the written direct testimony of Petitioner’s seven witnesses (P. Exs. 1-7).4 See
Order § 10.

II. Issue

The issue in this case is whether Petitioner was in substantial compliance with
participation requirements from July 18, 2012 to December 1, 2012. Because, as
explained below, I conclude that Petitioner was in substantial compliance on the relevant
dates, I do not need to consider whether CMS’s immediate jeopardy findings are clearly
erroneous or the CMPs that CMS imposed are reasonable.

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

This case involves the care Petitioner provided to two residents, Residents 1 and 2. CMS
alleges Petitioner continued to use assistive devices with Residents | and 2 after the
residents had accidents, without assessing their safety, leading to the regulatory citations
noted above and justifying the imposition of the CMPs at issue. As discussed below, I
find that at all relevant times Petitioner was in substantial compliance with participation
requirements. I first discuss the facts relating to the two residents and then discuss why
the facts do not support a conclusion that Petitioner was out of substantial compliance
with the participation requirements at issue. My findings of fact and conclusions of law
in this case are set forth in italics and bold font.”

* Below I rely on the testimony of Petitioner’s seven witnesses regarding the facts of the
case and, in the absence of other evidence, for their opinions consistent with their
education and training. As indicated below, I find that their testimony is consistent with
the documentary evidence.

> Petitioner noted in its final brief (P. Final Br. at 22-23) that CMS’s citation to the
record in its final brief was often either incorrect (i.e., citing to the medical record or
I. On July 18, 2012, facility staff found Resident 2 on the edge of her bed with her
flaccid left hand through an open area in the bed’s partial bed rail, following
which facility staff: assisted Resident 2 back into her bed, determined Resident
2 was unharmed; assessed and concluded that it was still appropriate and
necessary for Resident 2 to have partial bed rails on her bed; and immediately
implemented additional interventions for Resident 2, including additional
physical therapy related to the use of the bed rails, adding a bed pressure alarm,
ensuring safety mats were on the floor by the bed, moving the bed to a lower
position, and placing bed controls out of Resident 2’s reach.

Resident 2 was a 68-year-old woman who was admitted to the facility on June 20, 2012
(and readmitted on August 25, 2012 after a hospital stay) with diagnoses that included
cerebral vascular accident (CVA), left sided hemiparesis secondary to the CVA,
dysphagia, and multiple pressure ulcers. CMS Ex. 4 at 2; CMS Ex. 18 at 7, 8, 10; P. Ex.
3 at 2 4 15; P. Ex. 4 at 2416. RN Freshour, a restorative nurse at Petitioner’s facility,
testified that due to Petitioner’s “flaccid” left arm she could not independently move the
arm and had to use her right hand to reposition her left arm. P. Ex. 3 at 3925. DON
Jones testified that Resident 2’s left arm was “completely non-functional” and like a
“noodle.” P. Ex. 4 at 2 26. While Petitioner assessed Resident 2 as having physical
problems as a result of her CVA, Resident 2 was not assessed as having problems with
cognitive or mental status. CMS Ex. | at 6; CMS Ex. 18 at 28-29, 54, 68-69, 94, 124,
125; P. Ex. 6 at 4.38.

On the day of her admission, June 20, 2012, the facility completed a side rail evaluation
for Resident 2. The evaluation showed that the resident was not noted to have an
alteration in safety awareness due to a cognitive decline. It noted that the resident had a
history of falls; demonstrated poor bed mobility; had difficulty moving to a sitting
position on the side of the bed; had difficulty with balance or poor trunk control; and was
currently using side rails for position or support. The side rail evaluation recommended
that: side rails were indicated to serve as an enabler to promote independence; the
resident expressed a desire to have side rails raised while in bed; and that half rails were
necessary to assist with repositioning. The side rail evaluation also called for Resident 2
to be assessed by physical therapy regarding her current functional ability. CMS Ex. 18
at 5; P. Ex. 3 at 2 ¥ 16-17; P. Ex. 4 at 2 § 18-20. On June 20, 2012, Resident 2, who was

other exhibit for Resident 1 when referring to Resident 2) or overbroad (i.e., citing to the
entire medical record of a resident (a 129 page exhibit for Resident 2 (CMS Ex. 18) anda
274 page exhibit for Resident 1 (CMS Ex. 17)) when making a specific point. See, e.g.,
CMS Final Br. at 1-2. Moreover, although CMS withdrew the exhibit, its final brief still
references and relies on CMS Ex. 21, Surveyor Wilson’s written direct testimony. CMS
Final Br. at 2. CMS’s citation in this regard has made it difficult to credit CMS’s
arguments in support of its initial determination.

mentally competent, signed an “Informed Consent for Use of Side Rails.” CMS Ex. 18 at
14. Bilateral quarter rails were fitted to her bed.° P. Ex. 4 at 2421.

The informed consent that Resident 2 signed on June 20, 2012 reflects her
acknowledgment that she understood the risks of side rails (which include getting caught
in the rails, between the rails and mattress, strangulation, hitting against the rails causing
skin tears and/or bruising, and crawling over the top of the rail risking a fall and injury or
death). She also acknowledged that she understood that alternative methods of treatment
were available to her, including positioning, placing her mattress on the floor, placing a
mat on the floor next to her bed, and use of a new specialty bed. Despite these
alternatives, Resident 2 decided to use rails for safety and mobility. CMS Ex. 18 at 14.

LPTA Williams testified that he provided physical therapy services to Resident 2 in July
2012. He testified that they “work[ed] on bed mobility skills, including the safe use of
alf rails that were on both sides of her bed for rolling to help with hygiene and for
transferring from a supine to a sitting position for functional independence.” He also
“instructed Resident 2 to use her unaffected upper extremity to reach over and grab onto
the side rail in order to use her own strength in that arm to pull so that she could roll over
onto her side, slide her legs over the edge of the bed, and push herself up into a sitting
position on the side of the bed.” P. Ex. 7 at 1; P. Ex. 8.

On July 18, 2012, at around 8:40 a.m., LPN Little testified that she heard someone call
for assistance. She entered Resident 2’s room and saw that a certified nursing assistant
(CNA), Courtney Clark, was assisting Resident 2. LPN Little testified she saw Resident
2 “partially sitting on the bed with her feet on the floor and her left arm through the
opening in her quarter rail. She was very calm and did not appear to be in any distress.”
P. Ex. 5 at 1-2 §§ 13-15. LPN Little’s testimony is consistent with a nursing note that she
made contemporaneous with the incident, stating that she observed Resident 2 with her
“lower half of body, from thighs down off of [the left] side of [the] bed when entering
room. Assisted back onto bed per staff.” CMS Ex. 11 at 32. On November 9, 2012,
CNA Clark described the incident in a written statement, stating that when she observed
Resident 2 she was:

halfway out of her bed . . . left arm was in the bedside rail.
Her waist down was off the bed. I asked her what she was
doing and she said nothing. I got her legs and put them back
in the bed. I then removed her arm from the bedside rail.
There were no marks on her arm. I asked her if she was ok
and she said yes. There were mats on the floor by her bed. I

° T note that the side rail evaluation references half rails. But it appears bilateral quarter
rails were fitted to her bed. There is no indication in the parties’ submissions that there is
a material difference between the two types of rails for the purposes of this case.

have witnessed [Resident 2] use her bed side rail to pull
herself over while she is being changed.

P. Ex. 9. Another LPN, Rose Holman, stated in a written statement that she entered
Resident 2’s room and “saw [Resident 2] with her arm through the upper left bed rail and
er feet were on the floor mat. [Resident 2] never hit the floor that I witnessed.

Resident 2’s] back was still on bed.” P. Ex. 11.

DON Jones testified that Resident 2 had no history of trying to get out of bed without

assistance, her room was only two doors from the nurse’s station, and she was able to ask
for help when she needed it. DON Jones testified that she spoke to Resident 2 following
the incident. Resident 2 explained to DON Jones that she got up because she thought she
eard someone. DON Jones counseled her to ask for help the next time she needed
assistance and the resident responded: “Okay.” P. Ex. 4 at 3 9§ 35-37.

LPN Little completed an “Incident/Occurrence Report” regarding this incident. She
described the incident as “Resident in bed. Observed by staff sliding off side of bed
with] left arm through quarter side rail.” She stated that a complete body assessment
was done, and a red area was noted on her left cheek and left upper arm, but there were
no “open areas.”® At the time of the incident, the resident’s bed was in a high position,
the foot of the bed was elevated, and the resident could change the position of the bed (up
or down) at will. The Incident/Occurrence Report noted that interventions suggested to
address the incident were to: have physical therapy continue working with the resident;
have a bed alarm placed; have floor mats put beside the bed; keep the bed in a low
position; keep the bed control out of the resident’s reach; and have a side rail assessment
done. Handwritten notes appearing at the bottom of the first page of the report indicate
that Petitioner’s interdisciplinary team (IDT) reviewed the incident on July 19, 20, 23,
and 24, 2012. CMS Ex. 18 at 15-16.

Resident 2 was assessed by Nurse Practitioner Wanda Lancaster (NP Lancaster), at
around 9:00 a.m. on July 18, 2012. NP Lancaster made no recommendations for changes

7 Inconsistently, LPN Little stated in a Fall/Observed-on-Floor Incident Report
Worksheet and Fall/Change in Functional Status Report concerning the incident that
Resident 2 was sitting on the floor. CMS Ex. 18 at 17. However, the record otherwise
contradicts this statement and I find that the weight of evidence in the record supports
that Resident 2 received assistance while still partially on the bed and that Resident 2 did
not actually sit on the floor.

5 LPN Little testified, however, that the red areas on her cheek and ear were present on
admission, and that she did not know what caused a minor abrasion on Resident 2’s left
arm. P. Ex. 5 at 2 {fj 22-25.
10

in treatment. P. Ex. 3 at 4931; P. Ex. 4 at 3 § 38. DON Jones testified also that RN
Freshour interviewed and assessed Resident 2 and had her demonstrate how she used the
quarter rails to turn and reposition in her bed. P. Ex. 4 at 4 §§j 47-49.

RN Freshour testified that she interviewed and assessed Resident 2 as part of her normal
follow-up of residents involved in incidents.” She asked Resident 2 to perform a “return
demonstration” to show how she used the rails to move, turn, and reposition herself.
Resident 2 showed RN Freshour that she could use the rails appropriately and stated she
had a “strong desire” to keep them. P. Ex. 3 at 5 §§ 41, 42. Nursing notes prepared by
RN Freshour on July 20, 2012 support her testimony, stating “[r]esident
interviewed/assessed concerning using side rails. Resident states she uses both side rails
for turning [and] repositioning. Resident displayed how side rails were necessary for
this.” CMS Ex. 11 at 30.

DON Jones, who conducts clinical meetings with the facility’s IDT each morning during
the work week, testified that the IDT discussed Resident 2’s incident “at length” at its
morning meeting on July 18, 2012. P. Ex. 4 at 1,3 § 7, 40. They determined that the
factors identified in the June 20, 2012 side rail assessment (CMS Ex. 18 at 5) remained
the same. Resident 2 still had a history of falls, poor bed mobility, and difficulty with
balance and body control, and was still using a side rail for positioning in bed. They saw
no reason to change the “still-accurate” side rail assessment in her chart. P. Ex. 4 at 3-4
§§ 40, 41, 43, 46. RN Freshour also testified that the factors identified in Resident 2’s
June 20, 2012 side rail assessment were still accurate following the July 18 incident. P.
Ex. 3 at 4 4 33.

DON Jones testified that both RN Freshour and LPTA Williams told her that Resident 2
continued to need side rails in her bed for positioning, because she could not turn over
without them. P. Ex. 4 at 449. RN Freshour testified that, without the side rails,

° RN Freshour, the facility restorative nurse, testified that she works with a staff of
restorative aides to evaluate and assist residents completing physical therapy in order to
help them maintain their level of functioning. She conducts monthly, quarterly and
annual assessments of all the facility’s residents and she regularly reviews side rail, fall
risk, restraint and other assessments. She reviews and logs incident reports with the
facility’s IDT and keeps the incident reports in her office. When changes are made to a
care plan in response to an incident she routinely conducts in-service sessions with the
nurses responsible for the patient to ensure changes are communicated to the care staff.
She also observes the patient for a few days to confirm that the interventions are an
appropriate and effective response. The restorative aides she supervises check daily to
see all safety alarms are in place and working and that batteries are changed, and they
document these activities. RN Freshour served as a nursing home surveyor for the state
of Tennessee from 2004 to 2009. P. Ex. 3 at 1-2 4§ 1-14.
11

Resident 2 would have been at risk for falling, unable to engage in the turning and
repositioning necessary to keep pressure off existing and potential areas of skin
breakdown, and that the rails were necessary for her mental and psychosocial well-being.
P. Ex. 3 at 2-3 §§ 20-22.

Although Resident 2’s assessment did not change, the facility immediately implemented
the interventions documented in the incident report, which included having physical
therapy work with the resident, putting in place a bed pressure alarm, ensuring safety
mats were placed on the floor by the bed, moving the bed to a low position, placing the
bed controls out of reach, and having a side rail assessment done. P. Ex. 3 at 4 9§ 34, 35;
P. Ex. 4 at 4.9 44; P. Ex. 6 at 5 9 53, 54. DON Jones testified that the bed alarm was
particularly important because it helped notify staff of any attempt by the resident to get
out of bed without assistance. P. Ex. 4 at 4745. RN Freshour, LPN Little, and RN
Wenzler testified that a daily alarm report was begun on July 19, 2012, to confirm that
Resident 2’s alarm was in place and Petitioner’s staff monitored the alarm daily
thereafter. P. Ex. 3 at 4 36; P. Ex. 5 at 3 30; P. Ex. 6 at 5 9 58; P. Ex. 13. The facility
also changed the resident’s care plan to note that she could have bilateral side rails in the
up position while in bed. CMS Ex. 18 at 115.

Resident 2 was discharged to the hospital on August 14, 2012, and readmitted to
Petitioner on August 25, 2012. DON Jones testified that upon readmission her side rails
were replaced with halo rings; halo rings can be a safer assistive device because they
present less risk of skin tears. The halo rings were on Resident 2’s bed during the survey.
P. Ex. 4 at 4-5 50-55.

2. On October 18, 2012, after facility staff found Resident 1 sitting on the floor in
Sront of her wheelchair with the wheelchair’s releasable seat belt around
Resident 1’s chest, facility staff: assisted Resident 1 into her bed and determined
Resident 1 was unharmed; concluded that Resident 1 slipped from the
wheelchair when Resident 1 tried to remove a blanket from underneath her;
informed Resident 1’s physician of the incident the next morning; assessed and
concluded that Resident 1 should not have a seat belt on her wheelchair any
longer and that Resident I needed a new cushion in the wheelchair; removed
the seat belt from the wheelchair and added a new cushion to the wheelchair;
and, at Resident 1’s request, added a new releasable seat belt to Resident 1’s
wheelchair after Resident 1 and her family protested the removal of the seat belt.

Resident | was admitted to the facility on August 12, 2009. CMS Ex. 17 at 6. Resident 1
still resides at the facility. P. Ex. 4 at 556. Resident 1 had diagnoses including CVA,
left-sided hemiplegia, muscle weakness, a history of drug abuse, and bipolar disorder.
CMS Ex. 17 at 1; P. Ex. 3 at 5 949; P. Ex. 4 at 5 § 56; P. Ex. 6. at 6971. She was
admitted from another nursing home with a physician’s order in place for a self-releasing
seat belt. P. Ex. 3 at 5 449; P. Ex. 16 at 1. Resident 1’s care plan for fall related injury
12

notes that the seat belt should be checked every 30 minutes and released for 10 minutes
every two hours. It also notes that the resident can self-release and prefers and requests a
seat belt and that the seat belt was to be marked for the area to be fastened for comfort.
CMS Ex. 17 at 158. Because Resident 1 could release her seat belt on command, it was
not viewed as a restraint and no restraint assessment was done. P. Ex. 3 at 5-6 {§ 49, 50;
P. Ex. 4 at 5 9] 56, 57; P. Ex. 16. DON Jones testified that based on her observations of
Resident 1, the seat belt was used less as an assistive device to keep her from falling out
of her chair and more to address her psychological and emotional needs. P. Ex. 4 at 5
58.

RN Freshour testified that Resident 1’s use of the seat belt was monitored and assessed as
an assistive device on a regular and ongoing basis and her use of the seat belt was
frequently discussed by Petitioner’s staff. RN Freshour testified that Resident 1 engaged
routinely in attention-getting behaviors: going down the hall in her wheelchair crying
and screaming to get attention; and accusing staff and other residents of calling her
names, stealing her belongings, and going into her room in her absence. She also
complained that the self-releasing seat belt was too tight, and she loosened it and slid
forward in her wheelchair. RN Freshour testified further that to prevent these behaviors
she brought in white fingernail polish and drew a line on Resident 1’s self-releasing seat
belt to mark the safest and most comfortable setting. However, Resident | still continued
to loosen her seat belt as an attention getting behavior. Resident 1’s behavior of
loosening her seat belt was a regular topic of conversation at morning meetings and her
chart was discussed almost daily. Resident 1 was sent to a psychiatric hospital numerous
times for counseling and review of her medication regimen and was regularly seen by a
psychologist. P. Ex. 3 at 6 Jf] 51-56.

Despite her conduct, however, Resident 1’s mental status was assessed as alert and
oriented to year and month. See, e.g., CMS Ex. 17 at 28, 196. As RN Wenzler testified,
the resident is “mentally cognizant.” P. Ex. 6 at 6 § 73; see also CMS Ex. | at 9.

DON Jones also testified that Resident | had a history of attention-getting behaviors, one
of her most common being to complain that her seat belt was too tight, and she would
then loosen the belt and slide forward in her wheelchair to the edge of the seat. DON
Jones noted that to combat this behavior a white line was marked on the seat belt, at a
safe and comfortable setting, in an effort to keep the belt at that setting. However,
Resident 1 still complained about the belt being too tight and loosened it. Petitioner’s
IDT reviewed this behavior regularly at morning meetings. P. Ex. 4 at 5 §§ 59-61.

RN Efflandt, a charge nurse on the wing where Resident | resided at the time relevant to
this case, testified that Resident 1 spent most of her time in a wheelchair and had a self-
releasing seat belt in the wheelchair. RN Efflandt testified she observed Resident 1
loosen her seat belt and slide to the front of her chair to get attention, create drama, and
get staff to pay attention to her, especially after an incident where she had physically or
13

verbally abused a staff member or other resident “so that she would look like the victim
and get sympathy.” Resident | used her right hand to loosen her seat belt because she
had left-sided hemiplegia, which left her unable to use her left arm. Resident 1 had
contractures on her left hand that made her unable to use it. Resident 1 could not lift her
left arm away from her body enough to get the seat belt over it, so RN Efflandt did not
view the seat belt as a choking risk. P. Ex. 2 at 1 §§ 6-17.

On October 18, 2012, RN Efflandt was working the 6:00 p.m. to 6:00 a.m. shift. See P.
Ex. 2 at 2 429. RN Efflandt wrote in Resident 1’s nurse’s notes that at 7:00 p.m.:

CNA walked to the resident’ room and found resident sitting
on the floor in front of her chair. Resident states “I slid from
the chair because I was sitting on the blanket.” Prior to
incident, CNA Charles tightened resident’s waist belt after
she used the bathroom. Resident has no injury or bruises.

CMS Ex. 11 at 26.

RN Efflandt testified that on the evening of October 18, 2012, CNA Charles Saylor
(CNA Saylor) called her to Resident 1’s room. CNA Saylor told RN Efflandt that he had
taken Resident | to the bathroom and left her, for a few minutes, with her seat belt tight
in her wheelchair. He came “back a short time later to find her out of the seat of her
wheelchair with her seat belt still around her.” RN Efflandt does not recall whether CNA
Saylor told her whether Resident 1 was on the floor or on the footrests of her wheelchair.
When RN Efflandt saw Resident 1, the resident was seated on the floor and her seat belt
had been unfastened. RN Efflandt testified that Resident 1 did not appear to be agitated,
scared, or upset. Resident | told RN Efflandt that she slipped from her chair because she
was sitting on a blanket. RN Efflandt and CNA Saylor put Resident | back in bed,
checked her vital signs, and performed an assessment. Based on her observation and
assessment, RN Efflandt testified that Resident | did not suffer any injury as a result of
sliding from her wheelchair. P. Ex. 2 at 1-2 J 18-24, 26; see CMS Ex. 17 at 18.

During the course of her shift that night, RN Efflandt completed a change of condition
form, an incident report, and a nursing note regarding the incident. P. Ex. 2 at 2 4 28;
CMS Ex. 11 at 26; CMS Ex. 17 at 16. RN Efflandt noted in an “‘incident/occurrence”
report that:

CNA walked in the resident’s room and found the resident
sitting on a floor in front of her chair. Resident states: “I slid
from the chair because I was sitting on the blanket.” CNA
Charles tightened resident’s wheelchair waist belt after she
used the bathroom prior to incident. When the resident was
observed on a floor the waist belt was loose.

14

CMS Ex. 17 at 16. RN Efflandt noted that the contributing factor/root cause of the
incident was that the resident had a blanket on her wheelchair which caused her to slide
to the floor. As interventions, she noted the facility would: remove the blanket from the
wheelchair; order a wheel chair cushion; and remove the resident’s seat belt. CMS Ex.
17 at 17.

DON Jones testified that she entered Resident 1’s room while RN Efflandt was
performing the assessment of the resident. DON Jones testified “I asked Resident 1 what
ad happened and she said that she had been sitting on a blanket and was trying to get it
out from under her.” DON Jones instructed that Resident 1 be put to bed. P. Ex. 4 at 6
q9 64, 65.

RN Efflandt faxed Petitioner’s physician at the end of her shift, 6:00 a.m. on October 19,
2012, to notify him of the incident. RN Efflandt testified that she did not believe it was
necessary to notify him earlier because Resident 1 was not injured and her behavior did
not change from “what it had always been.” RN Efflandt testified that she did not see a
significant change in condition requiring physician notification outside of normal
business hours. Her expectation, based on past experience, was that the physician would
not see the FAX until he came in to work at 8:00 or 9:00 a.m. on the morning of October
19, 2012. P. Ex. 2 at 2 J] 29-32. DON Jones testified that this notification was timely
per Petitioner’s policy. Because Resident | suffered no injury and the incident occurred
after normal business hours, physician notification could wait until the end of the
reporting nurse’s shift. P. Ex. 4 at 6 J 66.

RN Efflandt testified that after the incident, the blanket was removed from Resident 1’s
chair and a new cushion was placed in the chair. P. Ex. 2 at 2 433. Resident 1’s care
plan reflects the blanket was removed from her chair and a new cushion ordered. CMS
Ex. 17 at 267, 272. RN Efflandt testified that at some point Resident 1 got a new
adjustable self-releasing seat belt. Resident | still loosens the belt and complains that it is
too tight. RN Efflandt testified that, based on her observations, Resident 1’s functional
status for use of a self-releasing seat belt in her wheelchair has not changed since the
October 18, 2012 incident. P. Ex. 2 at 2-3 §§ 34-36.

DON Jones testified that the IDT, after reviewing RN Efflandt’s October 18, 2012
incident report, recommended removing Resident 1’s blanket, which she used as a seat
cushion and getting her a new wheelchair cushion, which was done. In addition,
Resident 1 was counseled not to adjust her seat belt and was referred for psychiatric
consultation. P. Ex. 4 at 6 §§ 67, 68; CMS Ex. 17 at 272.

DON Jones testified that around the time of the October 18, 2012 incident, Resident 1’s
Lexapro, an anti-depressant medication, was discontinued. DON Jones testified that the
IDT initially considered removing Resident 1’s self-releasing seat belt, but it was not

immediately done.

15

The IDT believed that removing the seat belt would have been

extremely upsetting to Resident 1 and the IDT wanted to see what her reaction to the

levice for transfers

October 30, 2012, t
i
lemanded her seat
also asked for reins

was adamant that s!
am afraid I will fall

iscontinuation of t
very upset due to fa:

Lexapro would be before taking that step. Resident 1 was already
mily issues and the fact she had been placed on a sit-to-stand lift
on October 15, 2012, something she strongly disliked. DON Jones

testified that Resident 1 made it “crystal clear” that she needed her self-releasing belt to
protect herself from injury and that she would not willingly give it up. However, on

e facility removed Resident 1’s self-releasing seat belt and discarded

it for hygienic reasons. Resident 1 became hysterical, screamed at DON Jones, and

belt be put back at once. Resident 1’s former husband and two sons
tatement of the seat belt. DON Jones explained to Resident | and her

family that she would re-evaluate the situation in consultation with the IDT. Resident 1

e have a seat belt. DON Jones testified that Resident | asserted: “I
.” DON Jones testified that in January 2012, Resident | suffered a

fall after releasing
part led to her

DON Jones testifie
DON Jones testifie

she was critical of t!

DON Jones testifie

situation. Petit
seat belt picked ou
she attended a meet
Wenzler and RN Je:
benefits of the new
consent form for it,

>

CMS Ex. 17 at 269

promise to Resident

er son both stated t

er seat belt and fractured her shoulder, which DON Jones believes in

ear of falling. P. Ex. 4 at 6 {J 69-76, 82.

that the state surveyors entered Petitioner on November 1, 2012.
that Surveyor Wilson “questioned me intensively on why Resident

1’s seat belt had been removed. From the tone of her questioning, it was clear to me that

hat decision.” P. Ex. 4 at 7 9977, 78.

that she met with the IDT over several days and, consistent with her
1 and Resident 1’s family, Petitioner re-evaluated the seat belt

ioner determined to replace the belt with a self-releasing and adjustable

by Resident 1. Before deciding to do so, DON Jones testified that
ing with two corporate nurses from Signature Healthcare, LLC, RN
anne A. Boschert, and also NHA Boyce, to weigh the risks and

seat belt. Once they agreed on the new seat belt, they prepared a
which Resident | signed. DON Jones testified that Resident 1 and
ey were glad the seat belt was back. P. Ex. 4 at 7 4 79-81, 83-84;
(nurse’s notes reflecting November 4, 2012 meeting attended by

DON Jones, RN Wenzler, RN Boschert and NHA Boyce).

The consent form Resident | signed on November 4, 2012, reads:

I [Resident 1] want to express my desire to continue to be
allowed to wear my lap belt. I am fearful that without the belt

I will

fall and hurt myself like I did in January. When I fell in

January I had removed the belt myself and I then fell. Since

that ti

me the seat belt has been used. I did have an incident

on the 18" in which I was attempting to get my blanket out
from under me and I slid forward in my chair and the belt
16

actually caught me under my arms and possibly prevented
another more serious injury or break if I had not had it
present.

The staff has discussed with me in detail the possible risks of
this belt and I continue to choose to wear it for my emotional
comfort as well as my physical safety.

I expressed to [RN Boschert] on 11-3-12 at 5pm that the fall
on the 18" to me was “not a big deal” because I could have
released the belt if I felt that I was in any danger. | also told
her that I had a much greater fear of falling and possibly
breaking something than of encountering an injury with the
belt.

The staff has given me choices regarding my belt and has
asked that I demonstrate my ability to release it. I also
understand that if I become unable to release the belt or my
condition changes, then I will be reassessed and alternative
actions may be recommended.

CMS Ex. 17, at 274.!° DON Jones testified that since the new seat belt was put in use,
staff has documented twice daily that Resident 1 can release it on her own. P. Ex. 4 at 7
q 85.

DON Jones testified that the IDT found no feasible alternatives to the self-releasing seat
belt and ultimately concluded that honoring Resident 1’s wish to keep the device in place
was their best option. A non-releasing belt would have constituted a physical restraint
that could have impaired Resident 1’s mental and physical well-being, and could have
resulted in serious injury were she to slide out of it. The IDT decided that removing her
seat belt altogether might unnecessarily put her at risk of falling out of her wheelchair
while causing her great mental and emotional distress. P. Ex. 4 at 7-8 $j 87-88, 90.

'° CMS suggests that, despite Petitioner’s statement that Resident 1 continued to use a
seat belt as an exercise of her rights under 42 C.F.R. § 483.10, the consent form Resident
1 signed during the survey to continued use of a seat belt (CMS Ex. 17 at 274) was
simply an “attempt to absolve itself of responsibility for its noncompliance.” CMS Br. at
3-4. CMS has not shown, however, that Resident 1 was not competent to give such
consent, and the evidence of record shows that she (and her family) strongly desired that
a seat belt be used in her wheelchair.
with the new

RN Wenzler

wish to keep

risk for cho!
seat belt out
Resident 1’s

17

DON Jones testified that she does not believe Resident 1 was at risk of a choking injury
from the seat belt, since her hemiplegia prevented her from sliding in such a way as to get
er immobile left arm out from under the seat belt. P. Ex. 4 at 8 J 89.

DON Jones testified that the state surveyors had the opportunity to observe Resident 1

self-releasing seat belt during the survey and had no complaint about its use.

P. Ex. 4 at 7 § 86.

testified that the IDT found that none of the alternatives to a self-releasing

seat belt were feasible, and that the best option was to honor Resident | and her family’s

the seat belt in place. Also, to put the resident in a non-self-releasing seat

belt would have constituted a restraint and required a physician’s order, and her physician
never suggested such a restraint was appropriate. Restraining her against her will could
violate her rights and harm her mental and psychosocial well-being. A non-self-releasing
belt could have put the resident at an increased risk of harm. Resident 1 was not at great

ing if she slid from the front of her wheelchair because she could not get the
from underneath her armpits, given her left-sided hemiplegia. Taking away
seat belt on a permanent basis could place her at risk of physical harm

because, instead of sliding forward in her wheelchair she could have toppled forward to
the ground and sustained a fracture or potential fatal head injury. Because she was
terrified of being without the self-releasing seat belt, and desperately wanted it to be in
place, taking it away permanently could have been harmful to her mental and
psychosocial well-being. P. Ex. 6 at 8-9 fj 103-111.

3. Petitioner did not fail to provide adequate monitoring, supervision and
assistive devices to prevent accidents and thus was not out of substantial
compliance with the regulatory requirement at 42 C.F.R. § 483.25(h).

CMS asserts that Petitioner failed to be in substantial compliance with the

requirement

for participation at 42 C.F.R. § 483.25(h) with regard to both Resident

1 and Resident 2. This regulation requires that:

§ 483.25 Quality of care.

Each 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.

(h) Accidents. The facility must ensure that —
18

(1) The resident environment remains as free of accident
hazards as possible; and

(2) Each resident receives adequate supervision and
assistance devices to prevent accidents.

The Statement of Deficiencies alleges that Petitioner contravened this requirement when
it failed to immediately assess for appropriate and safe use Resident 2’s bed rails and
Resident 1’s seat belt after falls with entrapment from the devices. CMS Ex. | at 11-12.

The Departmental Appeals Board (DAB) has explained that this section of the
regulations:

places a continuum of affirmative duties on a facility. A
facility must determine whether any condition exists in the
environment that could endanger a resident’s safety. If so,
the facility must remove that condition if possible, and, when
not possible, it must take action to protect residents from the
danger posed by that condition. Ifa facility has identified and
planned for a hazard and then failed to follow its own plan,
that may be sufficient to show a lack of compliance with
regulatory requirement[s]. In other cases, an ALJ may need
to consider the actions the facility took to identify, remove, or
protect residents from the hazard. Where a facility alleges (or
shows) that it did not know that a hazard existed, the facility
cannot prevail if it could have reasonably foreseen that an
endangering condition existed either generally or for a
particular resident or residents.

Maine Veterans’ Home — Scarborough, DAB No. 1975, at 6-7 (2005).

With regard to Resident 2, CMS alleges specifically that the resident could not use her
flaccid left arm to grasp the quarter bed rail in order to break her fall from the bed. Yet,
after entangling her left arm in the rail, Petitioner “took no steps” to free her environment
from this known hazard. Petitioner’s failure to remove the accident hazard placed
Resident 2 at risk for another accident, likely with injury given her frail physical
condition, history of falls, poor bed mobility, and difficulty with balance and body
control. CMS Final Br. at 4.

While a side rail not used in accordance with a manufacturer’s directions or one that is
defective or poorly maintained may be considered ipso facto an accident hazard, CMS
does not allege that was the case here. Nor does CMS allege that Resident 2’s initial
assessment or the initial placement of the side rail constituted a hazard. Instead, CMS
alleges that Petitioner’s response to finding Resident 2 with her arm through the side rail
19

contravened this regulatory requirement because, after the incident, Petitioner took no

steps to reassess the resident and remove the side rails CMS alleges were newly shown to
be hazardous.

I make no conclusion whether or not the incident actually constituted a fall, although I
note that the preponderance of the evidence shows that Resident 2 was not found on the
floor, but instead partially on the bed with her feet on the floor. Further, I note that
LPTA Williams was teaching Resident 2 to transfer from a supine to a sitting position on
the side of the bed. P. Ex. 7 at 1. I conclude that whether or not the incident constitutes a
fall, Petitioner had properly assessed and determined that Resident 2 needed the bed rails
that were in place on July 18, 2012. Further, after the incident, Petitioner took the
necessary steps to assess the resident, evaluate the risks of continuing to use side rails,
and institute interventions to keep her safe while at the same time maintaining her
mobility. CMS Ex. 18 at 15-16; P. Ex. 3 at 2-3 9§ 20, 21; P. Ex. 4 at 49/49. Although
Petitioner did not complete a new side rail evaluation form, I accept DON Jones’
testimony that Petitioner assessed Resident 2 following the incident and determined that
the side rail evaluation form itself did not have to be re-written because Resident 2’s

functional status was the same and the form was still “complete and accurate.” P. Ex. 4
at 4 99 42, 43.

Petitioner has shown that it completed an assessment that bed rails were needed for
Resident 2 and provided physical therapy to Resident 2 related to the use of the bed rails.
P. Ex. 3 at 2-3 9916-22; P. Ex. 4 at 2 § 18-23; P. Ex. 6 at 3-4 9q 34-39; P. Ex. 7; P. Ex.
8; CMS Ex. 18 at 5. Therefore, I conclude that the bed rails placed on Resident 2’s bed

did not create an environment that failed to be as free from accident hazards as possible
under 42 C.F.R. § 483.25(h)(1).

Further, the preponderance of the evidence in the record shows that following the July 18
incident, Petitioner quickly and carefully assessed the resident, evaluated use of the side
rails, and implemented new interventions to protect the resident. Resident 2 was assessed
by NP Lancaster immediately after the incident and NP Lancaster did not suggest any
changes in the resident’s treatment, including removal of the side rails. P. Ex. 3 at 4 9 31;
P. Ex. 4 at 3 38. RN Freshour later assessed the resident and asked her to show how
she used the rails to move, turn, and reposition herself, and Resident 2 showed RN
Freshour that she could use the rails appropriately and stated she wanted to keep them. P.
Ex. 3 at 5 9 41, 42; CMS Ex. 11 at 30. The incident was reviewed by Petitioner’s IDT at
the morning meeting on the day of the incident, July 18, 2012, and for several days
thereafter. P. Ex. 4 at 3 99 40, 41; CMS Ex. 18 at 15. Petitioner’s staff prepared an
incident report containing several interventions designed to protect the resident while still
maintaining the benefit of the side rails, including re-evaluating the use of the rails,

aving physical therapy continue to work with the resident, placing a bed pressure alarm,
placing safety mats on the floor, moving the bed to a low position, and placing the bed
controls out of reach. CMS Ex. 18 at 16; P. Ex. 3 at 4 J 32, 34; P. Ex. 4 at 4.9 44; P. Ex.

20

6 at 5.53. DON Jones testified that the bed alarm was particularly important as it would
notify staff if the resident attempted to get out of bed. P. Ex. 4 at 4945. These
interventions were implemented immediately. P. Ex. 3 at 4 35; P. Ex. 6 at5 954. CMS
does not explain why these interventions were an ineffective response to the incident,
especially given that Resident 2 was mentally cognizant and told DON Jones that she
would ask for help getting up in future. P. Ex. 4 at 3 § 36.

Petitioner also concluded that removing the rails would be detrimental to Resident 2.
Specifically, Petitioner’s care staff concluded that the resident’s side rails should not be
removed or replaced after the incident because without them there was no way she could
turn herself over. DON Jones testified that both RN Freshour and LPTA Williams found
after assessing Resident 2 that she needed the side rails in her bed for positioning because
she could not turn herself over without them. P. Ex. 4 at 449. RN Freshour testified
that without the rails on her bed Resident 2 would be at risk of falling with resultant
injury and would be unable to engage in the turning and repositioning necessary to keep
pressure off of existing and potential areas of skin breakdown. Moreover, RN Freshour
testified that not keeping the rails in place might be harmful to Resident 2’s mental and
psychosocial well-being, because it could contribute “to a feeling of being helpless and
trapped in her bed.” P. Ex. 3 at 2-4 J 20-22, 33, 34, 37-42.

Following the incident and the interventions implemented by Petitioner, Resident 2 had
no more problems with the side rails. Resident 2’s bed was later fitted with halo rings
instead of side rails, and the halo rings were on her bed during the state survey. DON
Jones testified that halo rings can be a safer assistive device than quarter rails because the
halo rings present less risk of skin tears. P. Ex. 4 at 4-5 99 51-55; P. Ex. 14. Placement
of the halo rings shows me not that Petitioner was noncompliant due to continued use of
the side rails, but instead illustrates Petitioner’s ongoing effort to address and evaluate
Resident 2’s safety while attempting to maintain her mobility in bed.

With regard to Resident 1, CMS references the decision in Briarwood Nursing Ctr., DAB
No. 2115, at 11 (2007), in asserting that “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.” The DAB has
held that although a facility is not to be held strictly liable for accidents that occur in the
facility, the facility is required to take reasonable steps to ensure that a resident receives
supervision and assistance devices designed to meet their needs and to mitigate
foreseeable risks of harm. While the facility may choose its own methods to prevent
accidents, the methods must be adequate under the circumstances. The adequacy of the
supervision and assistance devices depends on a resident’s ability to protect him or
herself from harm. Guardian Health Care Ctr., DAB No. 1943, at 17-18 (2004).

CMS alleges that Petitioner knew that Resident 1 frequently loosened her seat belt and
slid to the front of her wheelchair. CMS notes that Resident | fell out of her wheelchair
21

and injured her shoulder before the October 18 incident. Thus, the possibility of another
accident, which could result in serious injury, was apparent. Yet, Petitioner’s staff did
not discuss the risks associated with loosening the seat belt or consider interventions to
reduce the risk of injury. CMS argues that Petitioner’s failure to take reasonable steps to
supervise Resident 1 or to provide her with safe assistance devices placed her at risk for a
range of serious injuries, including death, fractures, cuts and abrasions. CMS Final Br. at
4-5. The record shows, however, that Petitioner’s staff did consider interventions to
reduce Resident 1’s risk of injury and did discuss with her the risk of loosening the
seatbelt during her time at the facility, including after the October 18 incident. However,
this mentally cognizant resident and her family insisted that she continue to use a self-
releasing seat belt.

Resident | began residing at the facility in 2009. From that time through to the incident
in question she used a self-releasing seat belt in her wheelchair. Her falls care plan
specifically noted the use of the seat belt and included instructions for staff to check and
release the seat belt and to mark the seat belt to show Resident 1 where she should fasten
it for her comfort. CMS Ex. 17 at 158. During this time also, Resident 1 would loosen
the seat belt and slide forward in her wheelchair as an attention seeking device.
Petitioner’s witnesses testified that Petitioner addressed those behaviors almost daily at
IDT meetings and had Resident 1 counseled about her attention seeking behaviors at a
psychiatric hospital and by a psychologist. Her medication regimen was also reviewed.
A white line was marked on her seat belt to show her where a safe and comfortable
setting was. P. Ex. 3 at 6 §§ 51-56; P. Ex. 4 at 5 §§ 59-61; P. Ex. 6 at 7 4§ 78-80.

Resident 1 stated, and Petitioner determined, that she slid out of her wheelchair on
October 18, 2012 due to her attempt to remove a blanket that she was sitting on. To
address the fall itself, Petitioner determined to remove the blanket and order a new wheel
chair cushion. Petitioner also instructed Resident 1 not to adjust her seat belt and referred
er for psychiatric evaluation. CMS Ex. 17 at 267, 272; P. Ex. 4 at 6 J] 67, 68. DON
Jones testified that the IDT considered removing Resident 1’s self-releasing belt entirely,
but determined to hold off doing so because removal of the belt would have been
upsetting to the resident. However, on October 30, 2012, they did remove her seat belt.
But they replaced it on November 4, 2012, given the strong desire of Resident | and her
family that she have a seat belt. In a consent form signed on November 4, 2012, Resident
1 indicated that staff discussed with her in detail the possible risks of the belt, but
Resident 1 indicated that she chose to wear it. This new seat belt could be loosened by
Resident 1 and was self-releasing as was her former seat belt. P. Ex. 6 at 8998. As RN
Wenzler testified, “[t]he state surveyors had the opportunity to observe Resident 1 with
the new self-releasing seat belt in place and had no complaint about it, as indicated by the
fact that they found no immediate jeopardy to be present after the removal of the original
self-releasing seat belt on October 30, 2012.” P. Ex. 6 at 94 102. The evidence shows
that the new self-releasing seat belt was functionally identical to the original seat belt.
Thus, it appears that the state surveyors found the facility in compliance with regard to

22

this resident exactly as she was on the day of the incident; using a wheelchair, although
now with a chair cushion, and with the same type of self-releasing seatbelt and no
additional interventions.

Therefore, I do not sustain a violation of 42 C.F.R. § 483.25(h) in this case.

4. Petitioner did not fail to assess the safety of devices that its residents
required for mobility and positioning and thus was not out of substantial
compliance with the requirement for participation at 42 C.F.R.

§ 483.20(b)(1) .

CMS asserts that Petitioner was out of substantial compliance with the regulation at
42 C.F.R. § 483.20(b)(1) with regard to both Resident | and Resident 2. This regulation
requires the following:

§ 483.20 Resident Assessment

The facility must conduct initially and periodically a
comprehensive, accurate, standardized, _ reproducible
assessment of each resident’s functional capacity. . . .

(b) Comprehensive assessments — (1) Resident assessment
instrument. A facility must make a comprehensive
ssment of a resident’s needs, using the resident
assessment instrument (RAI) specified by the State. The
assessment must include at least the following:

(i) Identification and demographic information.

(ii) Customary routine.

(iii) Cognitive patterns.

(iv) Communication.

(v) Vision.

(vi) Mood and behavior patterns.

(vii) Psychosocial well-being.

(viii) Physical functioning and structural problems.

(ix) Continence.

(x) Disease diagnoses and health conditions.

(xi) Dental and nutritional status.

(xii) Skin condition.

(xiii) Activity pursuit.

(xiv) Medications.

(xv) Special treatments and procedures.

(xvi) Discharge potential.

23

(xvii) Documentation of summary information regarding the
additional assessment performed on the care areas triggered
by the completion of the Minimum Data Set (MDS).

(xviii) Documentation of participation in assessment.

The assessment process must include direct observation and
communication with the resident, as well as communication
with licensed and nonlicensed direct care staff members on all
shifts.

CMS asserts that under this regulation, Petitioner is required to assess the safety of any
intervention or assistive device put in place for resident use. The DAB has indicated that
a facility’s use of an assistive device without a risk safety assessment is the basis for
finding a facility noncompliant with the regulation. Maine Veterans Home —
Scarborough, DAB No. 1975, at 10-14 (a safety assessment includes an analysis of the
risks and benefits of a particular assistive device initiated by a facility); Laurelwood Care
Ctr., DAB No. 2229, at 9 (2009).

CMS argues that although the regulation does not dictate when a facility must perform a
safety assessment, the comprehensive assessment requirement is broad because the need
to perform a safety assessment varies by resident and facility. Thus, it may be necessary
for a facility to assess a resident’s needs at a time not explicitly set forth in the regulation.
Here, CMS argues, “a consistent and systematic approach to the timing of safety
assessments was needed.” CMS Final Br. at 7.

Specifically, CMS alleges that Petitioner did not perform a safety assessment of Resident
2’s use of quarter rails and Resident 1’s use of an adjustable seat belt after their accidents.
CMS acknowledges that Petitioner evaluated Resident 2’s use of the rails on June 20,
2012, but asserts that it should have reassessed the Resident’s ability to continue to use
the rails after the July 18, 2012 incident to ensure that the evaluation was accurate. The
June 20 evaluation did not include a description of her physical condition on July 18 and
detail the reasons she slid from the bed. CMS indicates that without this information the
June 20 evaluation was incomplete and Petitioner did not have all the information
necessary to assess the safety of Resident 1’s continued use of side rails. CMS alleges
with regard to Resident 1 that Respondent did not perform a safety assessment prior to
her fall from her wheelchair and it did not assess her ability to continue to safely use the
seat belt after her accident. CMS Final Br. at 6.

However, CMS has not shown that Petitioner was required to use a specific form to
document that it assessed a resident for side rail safety after an incident with a side rail.
A facility is required to assess a resident after an incident and implement interventions to
protect that resident. Here, I conclude that Petitioner has shown through testimony and
documents that it assessed Resident 2 (a mentally cognizant resident), determined the
cause of the incident, assessed the resident’s use of side rails, and implemented

24

interventions to further protect the resident. CMS Ex. 18 at 15-16; P. Ex. 3 at 4-5 4§ 31-
42; P. Ex. 4 at 3-4 9¥ 35-49; P. Ex. 5 at 2-3 FJ 22-30; P. Ex. 6 at 5 9 51-62.

With regard to Resident 1, Resident 1 was admitted to the facility with a physician’s
order for a self-releasing seat belt and the facility had a care plan for its use. Because it
was not to be used as a restraint, no restraint assessment was done. Following the
incident, the facility assessed the root cause of the incident, determined that it was due to
the resident having a blanket under her, and the blanket was removed and a seat cushion
placed. The facility then assessed whether or not Resident | should continue to have a
self-releasing seat belt in her wheelchair and ultimately concluded that she should.
Resident 1’s consent form notes that Petitioner discussed with her the risks of a seat belt
and documents her intention to continue to use a seat belt. There is no evidence that
shows that the replacement self-releasing seat belt was any different in function from the
prior seat belt or that Petitioner performed any safety assessments or evaluations other
than what is in the record before me. CMS apparently concluded that this was sufficient
and found Petitioner in substantial compliance.

Therefore, I do not sustain a violation of 42 C.F.R. § 483.20(b)(1) in this case.

5. Petitioner did not have an ineffective quality assessment and quality
assurance committee and thus was not out of substantial compliance with
the requirement for participation at 42 C.F.R. § 483.75(o).

CMS asserts that Petitioner was out of substantial compliance with the regulation at 42
C.F.R. § 483.75(0) with regard to both Resident | and Resident 2. This regulation
requires that:

§ 483.75(0)

(0) Quality assessment and assurance.

(1) A facility must maintain a quality assessment and
assurance committee consisting of —

(i) The director of nursing services;

(ii) A physician designated by the facility; and

(iii) At least 3 other members of the facility’s staff.

(2) The quality assessment and assurance committee-

(i) Meets at least quarterly to identify issues with respect to
which quality assessment and assurance activities are
necessary; and

(ii) Develops and implements appropriate plans of action to
correct identified quality deficiencies.

(3) A state or the Secretary may not require disclosure of the
records of such committee except in so far as such disclosure
25

is related to the compliance of such committee with the
requirements of this section.

(4) Good faith attempts by the committee to identify and
correct quality deficiencies will not be used as a basis for
sanctions.

CMS does not assert that the IDT was not functioning as Petitioner’s quality assessment
and assurance committee, only that, if it was, it was not addressing problems identified
by these two incidents. CMS argues that the appropriate role for the IDT, assuming it
was intended to function as the quality assurance committee, was to identify systemic
causes of resident falls, recommend changes in policy or practice to prevent them, and
ensure that the recommendations it made were implemented. CMS alleges that the IDT
did not carry out this role here. Specifically, the IDT was not alerted by the developing
pattern of accidents and falls with assistive devices to a problem that needed attention.
Jewish Home of Eastern Pennsylvania, DAB No. 2380, at 9, 13 (2011) (petitioner failed
to implement a corrective action plan to prevent the recurrence of falls). CMS asserts
that the IDT was familiar with Resident 1’s use of a seat belt and tendency to loosen the
belt, but did not implement a plan to monitor her behavior, even after she fell out of her
wheelchair. Given that Petitioner was aware of the dangers associated with seat belts and
quarter bed rails (strangulation, entrapment, serious injury or death), the IDT was obliged
to review facility records and information and identify potential and actual quality
deficiencies that were systemic in nature and then develop a corrective action plan for
those deficiencies. Thus it is reasonable to conclude, CMS avers, that Petitioner did not
have a functioning quality assessment and assurance committee or that the IDT simply
failed to do what it was required to do under this section. Jewish Home of Eastern
Pennsylvania, DAB No. 2380, at 14. CMS Final Br. at 9-10.

These two isolated incidents, however, do not show the continuous pattern of falls found
in Jewish Home. There is unrebutted testimony that Petitioner’s IDT discussed the
incident regarding Resident 2 at length and addressed it several other times. CMS Ex. 18
at 15; P. Ex. 4 at 3-4 Jf 40-41, 43, 46; P. Ex. 6 at 5 99.55, 57. Interventions were
identified and implemented. P. Ex. 3 at 4-5 Jj 33-40; P. Ex. 4 at 3-4 9§ 40-48; P. Ex. 5 at
3 Gf 28-30; P. Ex. 6 at 5 Jf] 52-60; P. Ex. 13. With regard to Resident 1, there is
unrebutted testimony that the IDT was regularly reviewing Resident 1’s behavior and
weighing the risks and benefits of using a seat belt for the very specific behaviors of this
resident. Therefore, I do not sustain a violation of 42 C.F.R. § 483.75(0) in this case.
26

6. Petitioner did not fail to administer the facility effectively and thus was
not out of substantial compliance with the requirement for participation
at 42 C.F.R. § 483.75.

CMS asserts that Petitioner was out of substantial compliance with the regulation at
42 C.F.R. § 483.75 with regard to both Resident | and Resident 2. This regulation
requires that:

§ 483.75 Administration

A facility must 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.

CMS notes first that a deficiency citation alleging noncompliance with this requirement
may be derived from findings of noncompliance with other participation requirements.
Stone County Nursing & Rehab. Ctr., DAB No. 2276, at 15-16 (2009); Odd Fellow and
Rebekah Health Care Facility, DAB No. 1839, at 16-17 (2002); Asbury Ctr. at Johnson
City, DAB No. 1815, at 11 (2002). CMS asserts that the facts underlying the accident
prevention deficiency and the quality assurance systems deficiency provide “ample basis”
to find noncompliance under this regulation. CMS argues that the deficiencies show that
Petitioner’s resources were not being used effectively to protect its residents from
accidents or to ensure that they attained their “highest practicable well-being.” Stone
County Nursing & Rehab. Ctr., DAB No. 2276, at 16; see also Magnolia Estates Skilled
Care, DAB No. 2228, at 22-23 (2009); CMS Final Br. at 7-8.

CMS alleges specifically that Petitioner failed to perform individualized safety
assessments to fully investigate and address the root causes of the two residents’
accidents. Sunbridge Care and Rehab. for Pembroke, DAB No. 2170, at 31 (2008)
(management failed to ascertain whether staff was properly using equipment or analyze
why certain accidents occurred). Petitioner had a duty to determine if the side rails and
wheelchair seat belt were effective and safe assistive devices, particularly because the
side rail was on Resident 2’s left side, where she had no strength and Resident 1 had a
tendency to loosen her seat belt on an ongoing basis. Sunbridge Care and Rehab. for
Pembroke, DAB No. 2170, at 30 (facility failed to acknowledge that residents were using
assistive devices in an unsafe manner). CMS Final Br. at 7-8.

As noted above, however, the record shows that Petitioner did investigate the root causes
of the incidents, assess resident safety, and implement measures to address the incidents
while, as Petitioner asserts, it “labored continuously to find interventions for Residents |
and 2 that struck a proper balance between the safety needs and the psychological needs
27

of those residents.” P. Final Br. at 18. Therefore, I do not sustain a violation of 42
C.F.R. § 483.75 in this case.

7. Petitioner did not fail to timely notify Resident’ 1’s physician of a
change in the resident’s condition and thus was not out of substantial
compliance with the regulatory requirement at 42 C.F.R.

§ 483.10(b)(11).

CMS asserts that Petitioner was out of substantial compliance with the regulation at
42 C.F.R. § 483.10(b)(11) with regard to Resident 1. This regulation requires that:

§ 483.10

The resident has a right to a dignified existence, self-
determination, and communication with and access to persons
and services inside and outside the facility. A facility must
protect and promote the rights of each resident, including
each of the following rights: . . .

(b)(11) Notification of changes. (i) A facility must
immediately inform the resident; consult with the resident’s
physician; and if known, notify the resident’s legal
representative or an interested family member when there is —
(A) An accident involving the resident which results in injury
and has the potential for requiring physician intervention;

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

C) A need to alter treatment significantly (i.e., a need to
iscontinue an existing form of treatment due to adverse
consequences, or to commence a new form of treatment); or
D) A decision to transfer or discharge the resident from the
facility as specified in § 483.12(a).

apse

fe)

CMS states that Petitioner’s staff noted in the Incident/Occurrence Report that Resident
1’s physician was notified of the resident’s accident on October 18, 2012. CMS Ex. 17 at
16. However, Petitioner did not actually notify the resident’s physician until the next
day, October 19. CMS notes that the incident was reported at the end of the reporting
nurse’s shift because she believed the physician could only receive notice during regular
business hours. P. Ex. 2 at 2 §§ 29, 30. However, CMS alleges that the reporting
requirement does not contain a limitation to reporting a resident’s change in status only
during regular business hours. CMS notes Petitioner’s argument that it was unlikely
another fall would occur that night because the resident was put to bed. P. Br. at 22.

28

CMS alleges that Petitioner is unclear about its requirement to immediately report a fall.
Reporting a fall the day after it occurs is inconsistent with “immediately” reporting the
fall. CMS Final Br. at 10-11.

The question here is whether it is sufficient that Resident 1’s physician was notified of
the incident at the conclusion of RN Efflandt’s shift to comport with the immediacy
requirement in the regulation.

RN Efflandt faxed Petitioner’s physician at the end of her shift, 6:00 a.m. on October 19,
2012, to notify him of the incident. RN Efflandt testified that she did not believe it was
necessary to notify him earlier because Resident 1 was not injured and her behavior did
not change from “what it had always been.” RN Efflandt testified that she did not see a
significant change in condition requiring physician notification outside of normal
business hours. Her expectation, based on past experience, was that the physician would
not see the FAX until he came in to work at 8:00 or 9:00 a.m. on the morning of October
19, 2012. P. Ex. 2 at 2 JJ 28-32. DON Jones testified that this notification was timely
per Petitioner’s policy. Because Resident | suffered no injury and the incident occurred
after normal business hours, physician notification could wait until the end of the
reporting nurse’s shift. P. Ex. 4 at 6 § 66. CMS has not explained why this does not
comport with the applicable regulation.

While certainly there are situations where a resident’s physician must be notified more
quickly than at the end of a nursing shift, here, the resident was assessed, was uninjured,
and the facility understood how it was she slid from the wheelchair. The resident was
also placed in bed after the incident and not back in the wheelchair, giving Petitioner time
to implement its interventions. The record does not support that there was a significant
change in Resident 1’s condition warranting immediate consultation with a physician, nor
was there an accident that meets the requirement in the regulations. Therefore, I do not
sustain a violation of 42 C.F.R. § 483.10 in this case.

V. Conclusion

I reverse CMS’s imposition of a CMP on Petitioner because Petitioner has shown that it
was in substantial compliance with Medicare participation requirements in relation to
Resident | and Resident 2.

/s/
Scott Anderson
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
(FDA No. FDA-2014-H-2179)

Complainant
v.

Guirey, Inc. / Amy Guirey
d/b/a Village Pub,

Respondent.
Docket No. C-15-659
Decision No. CR3892
Date: May 26, 2015
INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) began this matter by serving an administrative
complaint on Respondent, Guirey, Inc. / Amy Guirey, d/b/a Village Pub, at 411 Mill
Street, Ortonville, Michigan 48462, and by filing a copy of the Complaint with the Food
and Drug Administration’s (FDA) Division of Dockets Management. The complaint
alleges that Village Pub impermissibly used a vending machine in a non-exempt facility,
thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.

§ 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140. CTP seeks to impose
a $250 civil money penalty against Respondent Village Pub. Respondent has failed to
comply with judicial directions to comply with discovery requests. I therefore strike
Respondent’s answer and issue this decision of default judgment.

I. Procedural History
The Respondent timely filed an answer to CTP’s complaint on January 16, 2015. I issued

an Acknowledgement and Prehearing Order (APHO) on February 2, 2015, that set
deadlines for parties’ submissions, including the March 2, 2015 deadline to request that
the opposing party provide copies of documents relevant to this case. The APHO further
stated that a party receiving such a request must provide the requested documents no later
than 30 days after the request. Also, item #16 “Sanctions for failure to comply with
orders,” stated that these included but were not limited to the dismissal of the complaint
or answer if a party failed to comply with any order.

CTP served Respondent with its request for documents on March 2, 2015. On April 14,
2015, CTP filed a Motion to Compel Discovery, requesting "that an order be entered

to require Respondent to comply with the Request for Production of Documents in its
entirety." CTP also moved to hold deadlines in abeyance, citing the need for “sufficient
time to review the requested documents.”

On April 24, 2015, I advised both parties that the Respondent had until May 1, 2015 to
either comply with discovery requests or file a Motion for Protective Order. I further
advised that failure to do so could result in sanctions, including the issuance of an Initial
Decision and Default Judgment finding Respondent liable for the violations listed in the
Complaint and imposing a civil money penalty.

On May 8, 2015, I ordered Respondent to either comply with CTP's Request for
Production of Documents, or provide satisfactory explanation showing good cause for its
failure to comply with the request, by May 15, 2015. I also reiterated that noncompliance
may result in sanctions, including dismissal of Respondent's request for hearing and the
issuance of an Initial Decision and Default Judgment finding Respondent liable for the
violations listed in the Complaint and imposing a civil money penalty. To date,
Respondent has failed to comply with discovery requests.

IL. Striking Respondent’s Answer

Respondent has neither complied with discovery requests, nor provided any explanation
for noncompliance, despite being ordered to do so. On April 24, 2015, I directed
Respondent to either comply with discovery requests or file a Motion for Protective
Order. Then on May 8, 2015, I ordered Respondent to either comply with discovery
requests, or provide satisfactory explanation for its noncompliance. Along with both of
these judicial directions, I informed Respondent that noncompliance could result in an
effective dismissal of this case.

The harshness of the sanctions I impose upon either party must relate to the nature and
severity of the misconduct or noncompliance, and I find Respondent’s failure to comply
with discovery requests sufficient to warrant striking the answer and issuing a decision.
21 C.F.R. § 17.35. [hereby strike Respondent’s answer, and assume the facts alleged in
CTP’s complaint to be true. See 21 C.F.R. §§ 17.35(c) (3), 17.11(a).
Ill. Default Decision

Striking Respondent’s answer leaves the complaint unanswered. Therefore, I am
required to issue an initial decision by default if the complaint is sufficient to justify a
penalty. 21 C.F.R. § 17.11. Accordingly, I must determine whether the allegations in the
complaint establish violations of the Act.

For purposes of this decision, I assume the facts alleged in the complaint are true and
conclude that default judgment is merited based on the allegations of the complaint.
21 C.F.R. § 17.11. Specifically:

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on December 17, 2014, CTP served the
complaint on Respondent Village Pub by United Parcel Service.

e Respondent owns Village Pub, an establishment that sells tobacco products and is
located at 411 Mill Street, Ortonville, Michigan 48462. Complaint 2.

e During an inspection of Respondent’s establishment on April 3, 2014, an FDA-
commissioned inspector observed “‘a cigarette vending machine in the
establishment and was told by the bartender on duty that minors are allowed to
enter until 9:00 PM or with a parent or guardian.” Complaint 4 10.

e On May 8, 2014, CTP issued a Warning Letter to Respondent regarding the
inspector’s observation from April 3, 2014. The letter explained that the
observation constituted a violation of the regulation found at 21 C.F.R.

§ 1140.14(c), and that the named violation was not necessarily intended to be an
exhaustive list of all violations at the establishment. The Warning Letter went on
to state that if Respondent failed to correct the violation, regulatory action by the
FDA or a civil money penalty action could occur and that Respondent is
responsible for complying with the law. Complaint ¥ 10.

e Amy Guirey responded to the Warning Letter in a May 22, 2014 email. “Ms.
Guirey stated that the vending machine ‘was equipped with a device that must be
activated by staff after a request is made and proper identification shown.’ On
June 11, 2014, by telephone, upon learning that the lockout device described in her
response letter was insufficient to satisfy the requirements of the Act, Ms. Guirey
indicated that the vending machine would be removed from Village Pub.”
Complaint § 11.

e During a subsequent inspection of Respondent’s establishment on July 21 and 30,
2014, an FDA-commissioned inspector observed “a cigarette vending machine in
the establishment and was told by an employee that minors are permitted to enter
when accompanied by an adult.” Complaint § 1.
These facts establish that Respondent is liable under the Act. The Act prohibits
misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is misbranded
if distributed or offered for sale in any state in violation of regulations issued under
section 906(d) of the Act. 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). The
Secretary of the U.S. Department of Health and Human Services issued the regulations at
21 C.F.R. pt. 1140 under section 906(d) of the Act. 21 U.S.C. § 387a-1; see 21 U.S.C.

§ 387£(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010). The regulations provide that
a retailer may sell cigarettes or smokeless tobacco only in direct, face-to-face exchange
without the assistance of any electronic or mechanical device (such as a vending
machine), 21 C.F.R. § 1140.14(c), except where no person younger than 18 years of age
is present in or allowed to enter the establishment at any time, 21 C.F.R.

§ 1140.16(c)(2)(ii).

Taking the above alleged facts as true, Respondent violated the prohibition against using
a vending machine in a non-exempt facility, 21 C.F.R. § 1140.14(c), on April 3, 2014,
and July 21 and 30, 2014. Therefore, Respondent’s actions constitute violations of law
that merit a civil money penalty.

CTP has requested a fine of $250, which is a permissible fine under the regulations.
21 C.F.R. § 17.2. Therefore, I find that a civil money penalty of $250 is warranted and so
order one imposed.

/s/
Steven T. Kessel
Administrative Law Judge