Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Hanover Hill Health Care Center
(CCN: 30-5009),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-13-671 (on remand)
Decision No. CR3745

Date: March 31, 2015

DECISION

Petitioner, Hanover Hill Health Care Center (Petitioner or facility), is a long-term care
facility located in Manchester, New Hampshire, that participates in the Medicare
program. Following a survey completed on February 11, 2011, the New Hampshire
Department of Health and Human Services (state agency) determined that the facility was
not in substantial compliance with Medicare participation requirements, and that the
facility’s noncompliance posed immediate jeopardy to the health and safety of facility
residents. Specifically, even though staff recognized that one of its demented residents
tended to “shovel peanut butter” into his mouth and had recently exhibited difficulties
swallowing, they left him alone and unsupervised with crackers covered in peanut butter.
He choked to death, with “large amounts” of the peanut butter lodged in his throat.

Based on the state agency’s findings, the Centers for Medicare & Medicaid Services
(CMS) imposed a per-instance civil money penalty (CMP) of $7,500. Petitioner
appealed, and, in a decision dated September 20, 2012, I found that the facility was not in
substantial compliance with Medicare participation requirements and that the penalty
imposed was reasonable. Hanover Hill Health Care Ctr., DAB CR2617 (2012).
The matter is back before me on remand from an appellate panel of the Departmental
Appeals Board. Hanover Hill Health Care Ctr., DAB No. 2507 (2013). The Board
instructed me “to consider or explain evidence not fully addressed” in my initial decision.
Id. at 23.

Having reviewed the record in this case in light of the Board’s comments, | find that
Petitioner was not in substantial compliance with Medicare participation requirements
and that the penalty imposed is reasonable.

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 annually, with
no more than fifteen months elapsing between surveys. Facilities must be surveyed 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.

The state agency surveyed the facility between February 9 and 11, 2011, and cited
deficiencies related to the care provided to a resident referred to as “Resident 17” (R17).
Among other deficiencies, the state agency cited two at the immediate jeopardy level,
concluding that the facility did not address sufficiently R17’s demonstrated swallowing
difficulties nor adequately protect him from harm:

© 42 CFR. § 483.13(c) (Tag F-224) (prohibit neglect), for failing to ensure that the
facility implemented policies and procedures to prohibit neglect of R17; and

e 42C.F.R. § 483.25 (Tag F-309) (quality of care), for failing to provide a
comprehensive assessment to determine the appropriate interventions for R17’s
swallowing difficulties.’

' The state agency cited the facility for five related deficiencies that did not cause actual
harm, with the potential for more than minimal harm: 42 C.F.R. §§ 483.13(c)(1)(ii)-(iii),
(c)(2)-(4) (failing to report the results of an allegation of neglect within five days);
The state agency also determined that the immediate jeopardy had abated at the time of
the survey, and that the facility achieved substantial compliance as of March 9, 2011.
CMS adopted the state agency’s findings and imposed a $7,500 per-instance CMP.

In the original proceedings in this case, I admitted into evidence CMS Exs. 1-14 and P.
Exs. 1-28. I convened a hearing by video teleconference on January 23, 2012. Ms. Jill
Steinberg appeared on behalf of CMS, and Mr. Joseph Bianculli appeared on behalf of
Petitioner.

IL. Issues
This case presents the following issues:

1. Was the facility in substantial compliance with 42 C.F.R. § 483.13(c) (Tag F-224
— staff treatment of residents, abuse/neglect policies) and 42 C.F.R. § 483.25 (Tag
F-309 — quality of care); and

2. Ifthe facility was not in substantial compliance, is the penalty imposed — $7,500
per-instance — reasonable.

I am not authorized to review CMS’s immediate jeopardy determination. An
administrative law judge may review CMS’s scope and severity findings (which include a
finding of immediate jeopardy) only if a successful challenge would affect the range of
the CMP or if CMS has made a finding of substandard quality of care that results in the
loss of approval of a facility’s nurse aide training program. 42 C.F.R. § 498.3(b)(14);

42 C.F.R. §§ 498.3(b)(14), 498.3(d)(10); Cedar Lake Nursing Home, DAB No. 2344 at 9
(2010); Evergreen Commons, DAB No. 2175 (2008); Aase Haugen Homes, DAB No.
2013 (2006). For a per-instance penalty, the regulations provide only one range ($1,000
to $10,000), so the level of noncompliance here does not affect the range of the CMP.

42 C.F.R. § 488.438(a)(2).

The facility apparently does not operate a nurse aide training program. CMS Ex. 14 at 1.
Even if it did, CMS’s scope and severity finding would not affect approval of such a
program. By statute and regulation, if, as here, CMS imposes a penalty of $5,000 or

483.13(c) (failing to report its investigation results within five days); 483.20(d)(3)
(failing to update R17’s comprehensive care plan); 483.75 (failing to administer the
facility in a manner that enabled it to provide residents with their highest practicable
well-being); and 483.75(i) (medical director’s failing to ensure adequate care and services
be provided to R17, who had a history of choking). CMS did not impose any remedies
for these deficiencies, however, expressly limiting the penalty to those deficiencies cited
at the immediate jeopardy level.
more, the state agency cannot approve the program, so the facility would lose its approval
without regard to the immediate jeopardy finding. Act § 1819(f)(2)(B); 42 C.F.R.
§ 483.151(b)(2)(iv).

Thus, because the immediate jeopardy finding here does not affect the range of the CMP
or cause the facility to lose approval of its nurse aide training program (if it has one), the
finding is not reviewable.

III. Discussion

A. Petitioner was not in substantial compliance with 42 C.F.R § 483.13(c) and
42 C.F.R. § 483.25 because the facility did not implement its policy
prohibiting resident neglect and did not provide the necessary assessment,
care, and services to R17 to address his exhibited swallowing difficulties
and to keep him safe and free from neglect.”

The deficiencies cited under sections 483.13(c) and 483.25 stem from a common set of
facts. Compare, e.g., CMS Ex. | at 2-6 with CMS Ex. | at 12-18. This is neither
surprising nor uncommon. After all, if a facility does not “provide goods and services
necessary” for a resident to avoid harm (42 C.F.R. §§ 483.13(c), 488.301), it necessarily
fails to provide the “care and services” necessary to allow the resident “to attain or
maintain the highest practicable physical, mental, and psychosocial well-being.” 42
C.F.R. § 483.25. For this reason, and to avoid an unnecessarily lengthy and redundant
decision, I do not repeat the facts for each of the deficiencies cited, but, as appropriate, I
discuss how those facts put the facility out of substantial compliance with each of the
cited regulations. See, e.g., Liberty Health & Rehab of Indianola, LLC, DAB No. 2434
at 12 (2011) (“Although Liberty objects that the ALJ relied on the same analysis to
support his conclusion on noncompliance with all three cited requirements, the Board has
held that, in appropriate circumstances, a finding of noncompliance with section 483.75
may be derived from findings of noncompliance with other participation requirements.”);
Van Dunn Home & Hosp., DAB No. 2368 at 17 n.5 (2011) (“We also uphold the ALJ’s
conclusion that the same facts demonstrate noncompliance with 42 C.F.R. § 483.74
(administration) and 42 C.F.R. § 483.75(i) (medical director), given the fundamental
responsibilities of the administration and the medical director to ensure systems and
policies protect residents’ safety from foreseeable risks.”); Jennifer Matthew Nursing

& Rehab. Ctr., DAB No. 2192 at 50 (2008) (“Jennifer Matthew can demonstrate no
prejudice since the ALJ determined after [a] hearing (and we agree) that, based on its care
of R17 and of other residents during the heat wave, Jennifer Matthew was not in
substantial compliance with sections 483.13(c), 483.25, and 483.75.”).

> My findings of fact and conclusions of law are set forth, in bold and italics, as captions
in the discussion section of this decision.
In reaching my conclusions here, I have considered the evidence and arguments that
Petitioner raised — essentially, that it was not required to address R17’s risk of choking,
because he was not at risk; rather, his problems stemmed from behavioral issues, and, to
the extent that staff changed his care plan, they did so to address his behaviors, not his
ability to swallow. In accordance with the Board’s instructions, I have also considered
arguments that Petitioner did not raise — that some evidence (not relied on by Petitioner
and not “fully discussed” in my decision) might (or might not) suggest that the facility
addressed the swallowing issue.

Program Requirements. Facilities must develop and implement written policies and
procedures that prohibit resident neglect. 42 C.F.R. § 483.13(c). “Neglect” means the
failure to provide goods and services necessary to avoid physical harm, mental anguish,
or mental illness. 42 C.F.R. § 488.301.

Section 483.13(c) “addresses a deficiency related to lack of an effective policy as
opposed to one directed at the occurrence of neglect itself.” Emerald Oaks, DAB No.
1800 at 12 (2001). However, the drafters of the regulation characterized as “inherent in
[section] 483.13(c)” the requirement that “each resident should be free from neglect as
well as other forms of mistreatment,” 59 Fed. Reg. 56,130 (Nov. 10, 1994). The
regulation requires that the facility “implement” its anti-neglect policies. 42 C.F.R.

§ 483.13(c). Implementing a policy requires more than drafting and maintaining
documents. Staff must carry out and follow the policy. The Board has recognized that
examples of neglect can demonstrate that the facility has not implemented its policies.
Barn Hill Care Ctr., DAB No. 1848 at 9-12 (2002); Emerald Oaks, DAB No. 1800 at 18;
59 Fed. Reg. 56,130; see also The Cottage Extended Care Ctr., DAB No. 2145 at 4n.4
(2008); Liberty Commons Nursing & Rehab. Ctr.-Johnston, DAB No. 2031 at 7-17
(2006), aff'd, Liberty Nursing & Rehab. Ctr.-Johnston v. Leavitt, 241 F. App’x 76 (4th
Cir. 2007).

In addition, under the Act and “‘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 this end, the facility must eliminate or reduce a known
or foreseeable risk of accident “to the greatest degree practicable.” De/ Rosa Villa, DAB
No. 2458 at 7 (2012) (quoting Clermont Nursing & Convalescent Ctr., DAB No. 1923 at
9-10 (2004)), aff'd, Clermont Nursing & Convalescent Ctr., 142 F. App’x 900 (6th Cir.
2005)).

The Facility’s Policies and Procedures. The facility’s “Abuse Prohibition” policy
provides that the facility would “make every effort to prevent patient/resident . . . neglect
... by employing the seven components of prevention: screening, training, prevention,
identification, investigation, protection and reporting/response.” CMS Ex. 5 at 19. In the

“prevention” component, the policy says that the facility would, among other things,
“identify, correct, and intervene in situations in which . . . neglect . . . is more likely to
occur” and “[a]ssess, care plan for and monitor residents with needs and behaviors which
may lead to... neglect... .” CMS Ex. 5 at 19-20.

The facility’s “Monitoring Residents/Patients as Having Significant or Health Altering
Nutritional Issues” policy says that the facility will identify to the “Nutrition-at-Risk
Committee” residents with “significant, health altering nutritional issues.” CMS Ex. 5
at 2. The Nutrition-at-Risk Committee will review residents “who meet at least on[e] of
the following criteria: . . . (5) Score of 10 or above on malnutrition risk assessment.”
CMS Ex. 5 at 2. The Committee must discuss the resident’s nutritional issues, including
“current weight, variances in weight, current diet order and supplements, heath status
review, changes in cognitive/behavior status, and identification of co-founding factors.”
CMS Ex. 5 at 2.

R17’s Swallowing Difficulties. R17 was a 69-year-old man who suffered from a
multitude of conditions, including chronic venous insufficiency, dementia, diabetes, and
heart disease. P. Ex. 2 at 3. Over a three-week period — from an August 9, 2010 choking
incident until his August 29, 2010 death — R17 experienced five documented occasions of
choking or difficulty swallowing:

¢ On August 9, the facility’s nursing staff found R17 in his room, “red in face,”
choking on his lunch. CMS Ex. 6 at 41. A nurse performed “[two] pumps of the
[H]eimlich maneuver,” which dislodged the food and opened R17’s airway. CMS
Ex. 6 at 47; P. Ex. 18 at 3 (Bumford Decl.).

¢ On August 12, a nurse observed R17 “reddened in the face, attempting to cough
with difficulty” while eating apple slices, which he was “able to clear with thick
sputum and apple peels present in vomited remnants.” CMS Ex. 6 at 48.

¢ On August 14, R17 took his oral medication “with much difficulty.” CMS Ex. 6
at 50. The administering nurse reported that R17 “took a couple minutes to
swallow each individual pill,” and he “[r]efused to try taking pills with applesauce
or anything to aid with swallowing.” CMS Ex. 6 at 50.

e¢ On August 15, R17 “took a significant time to swallow each individual pill with
difficulty.” CMS Ex. 6 at 50. The nurse explained that R17 “tossed pills around
in his mouth and talk[ed] during swallowing.” She directed him to “focus on
swallowing during med[ication] administration to prevent choking, but [R17 is]
forgetful.” CMS Ex. 6 at 50. He again “refused to take pills crushed or with
applesauce to assist with swallowing.” CMS Ex. 6 at 50.
e On August 21, R17 had “difficulty swallowing pills,” and was “
inside of [his] cheek.” CMS Ex. 6 at 52. The nurse “[a]dded ap;

pills,” which was “helpful in assisting with swallowing.” CMS

August 9, 2010 Choking Episode. Nursing staff reported the August 9
to the facility’s speech and language pathologist (SLP), Heather Martti
R17’s swallowing functions and “observed [R17] consuming a regular
liquids.” CMS Ex. 6
without overt signs [or] symptoms of aspiration [or] choking,” and “no
clearing or change in
the “[c]hoking episode appears to be an isolated event” but recommend
staff monitor R17 over the “next few shifts.” CMS Ex. 6 at 47.

Nursing staff notified Physician’s Assistant (PA) Enieda Islamovic (co
primary care physician, Dr. Howard Suls), who issued no new orders.

Staff also notified R17’s daughter of the incident, and “reviewed and up

pocketing them
plesauce to whole
Ex. 6 at 52.

choking episode
la, who assessed.
texture with thin

at 47. SLP Marttila reported that R17 was “tolerating [food]

coughing, throat

subsequent vocal quality.” CMS Ex. 6 at 47. She concluded that

ed that the nursing

vering for R17’s
CMS Ex. 6 at 47.
dated” R17’s

plan of care to include allowing “ample time for resident to swallow medication” which,

it noted, was “secon

lary to possible swallowing issues.” CMS Ex. 6 at 41; P. Ex. 5 at 23.

The facility’s response to the August 9 choking incident presents no significant problems.
Staff identified signs of changes in swallowing function and timely notified the
appropriate personnel (SLP Marttila). SLP Marttila assessed R17’s swallowing function

and concluded that t
supervision for the “

Islamovic. Both SLP

meals for “a few shi
hours. CMS Ex. 6 at

CMS questioned the
and did not meet the
Hr’g Br. at 5 n.4. TI

e incident was likely “isolated,” although she recommended
next few shifts.” CMS Ex. 6 at 41, 47. Staff also notified PA
Marttila and PA Islamovic directed staff to monitor R17 during
fts,” and check his vital signs and lung sounds every shift for 72
it 42, 47.

adequacy of SLP Marttila’s assessment, suggesting it was a “screen”
assessment standards described in medical literature. CMS Post-
is case does not turn on the facility’s response to the August 9

incident, however. As the evidence establishes, in the three weeks following that

incident, facility sta’
swallowing difficult

isolated choking inci

not keep him safe.

ff made little effort to identify and address the causes of R17’s
ies despite growing evidence that those difficulties went beyond one
ident. Most important, knowing how vulnerable R17 was, they did

August 12, 2010 Incident. On August 12, staff found R17 “reddened in the face,

attempting to cough

with difficulty” while eating apple slices. CMS Ex. 6 at 48.°

> Why staff gave him apples is a mystery. An April 7, 2010 entry in his care plan

directed “NO APPLE

Ex. 5 at 16.

S per speech therapy recommendations.” (emphasis in original). P.
Petitioner offers no testimony from anyone who witnessed the entire episode, and it
appears that no one did.*

Petitioner now denies that R17 choked on or had difficulty swallowing the food, but
argues that he experienced a benign coughing episode, which did not merit further
attention. P. Post-Hr’g Br. at 13. I reject Petitioner’s position for two reasons: first,
coughing while eating (including before swallowing) is itself a sign of dysphagia that
merits further attention. See CMS Ex. 9 at 2 (Jeanie Kayser-Jones and Kathryn Pengilly,
Dysphagia Among Nursing Home Residents, 20 Geriatric Nursing 77, 78 (No. 2 1999));
CMS Ex. 10 at 5-7 (Carol Smith-Hammond and Larry Goldstein, Cough and Aspiration
of Food and Liquids Due to Oral-Pharyngeal Dysphagia: ACCP Evidence-Based
Clinical Practice Guidelines, Chest Journal (No. 129, 2006), describing “reflexive
cough” in response to presence of liquid or food in laryngeal area as a sign of possible
aspiration or dysphagia).

Second, the staff’s contemporaneous notes and reports consistently characterize the event
as “choking” or otherwise related to R17’s difficulty swallowing. Nurse Melissa
O’Donnell, who witnessed at least part of the incident, left a message with PA Islamovic
“regarding recent med[ication] change of [O]xycontin and any relation to swallowing
issues.” CMS Ex. 6 at 48 (emphasis added). The facility’s Registered Dietician (RD),
Amy Goulas, wrote that staff supervised R17 at meals due to “recent choking episodes on
apples.” CMS Ex. 6 at 37. RD Goulas now says “I should have been clearer in my note,
and written that the resident had started coughing while eating apple slices, and that in an
exercise of caution . . . | recommended replacement of that snack on his meal tray
ticket.”° I find this claim not credible. I find it more likely that RD Goulas, who was in
the facility but did not witness the incident, wrote “choking episodes” because staff
reported that R17 had choked on his food. See P. Ex. 19 at 3 (Goulas Decl.); CMS Ex. 6,
at 38. See Jennifer Matthew Nursing & Rehab. Ctr., DAB No. 2192 at 52 (2008) (finding
that the ALJ may reasonably give more weight to contemporaneous notes than to witness
testimony). Indeed, RD Goulas not only wrote that R17 is supervised at meals because of
“recent choking episodes on apples,” she emphasized that fact by writing an addendum:

* As discussed below, the Nutrition-at-Risk Committee apparently thought that staff
supervised R17 as he ate. CMS Ex. 6 at 37; see also CMS Ex. 7 at 3 (July 2010
assessment indicating that R17 needed a one-person physical assist with eating); but see
CMS Ex. 7 at 9 (May 2010 assessment indicating that R17 needed set-up help only for
eating). But the evidence establishes that staff did not supervise him. P. Ex. 18 at 5
(Bumford Decl.).

> RD Goulas admits that she ordered kitchen staff to stop providing apple slices to R17
because apple slices “can be a difficult food for some people to chew and swallow” (P.
Ex. 25 at 1). CMS Ex. 6, at 37, 48.
staff were “watching resident while in room [with] meals” on all three shifts. CMS Ex. 6
at 37.

This second incident cast sufficient doubt on SLP Marttila’s initial impression of a single
isolated incident to compel the facility to: 1) provide R17 with additional care and
services to keep him free from neglect (42 C.F.R. § 483.13(c)); and 2) identify the
underlying cause and, as possible, treat his swallowing issues so that he could attain his
highest practicable physical, mental, and psychosocial well-being (42 C.F.R. § 483.25).
The evidence establishes that the facility fell short on both counts.

Difficulty Swallowing Medication. On August 14, August 15, and August 21, nurses
documented that R17 had difficulty swallowing his medication. P. Ex. 7 at 31-33; CMS
Ex. 6 at 50, 52. Petitioner dismisses these incidents as attributable to R17’s behavior
problems. P. Post-Hr’g Br. at 9; P. Ex. 18 at 2 (Bumford Decl.) (describing R17 as
“manipulative,” and claiming that “sometimes” he refused medications from certain
nurses); accord P. Ex. 20 at 2 (Ballentine Decl.); P. Ex. 21 at 2 (Ouellette Decl.); P. Ex.
23 at 1 (Turgeon Decl.); P. Ex. 24 at 3 (Foster Decl.).

I have no doubt that R17, who suffered from dementia likely caused by organic brain
syndrome (see CMS Ex. 6 at 1-2), was often sarcastic, rude, and socially inappropriate.
CMS Ex. 6 at 11. That R17 exhibited these behaviors, however, does not preclude the
very real possibility that he was developing a problem swallowing and that he had
difficulty swallowing his medications. Indeed, refusing to swallow may itself signal
swallowing problems; and it is not uncommon for staff to mistake genuine swallowing
problems as the resident’s “deliberately being difficult.” See CMS Ex. 9 at 3 (Kayser-
Jones and Pengilly, 20 Geriatric Nursing at 79). According to R17’s care plan, he may
ave resisted taking oral medications because of his problems with swallowing. The care
plan entry, dated August 9, 2010, says “Resident often takes a long time to swallow pills
secondary to possible swallowing difficulties.” CMS Ex. 6 at 24 (emphasis added); P.
Ex. 5 at 23.

Even more compelling, the nurses’ notes that document R17’s difficulties taking oral
medication describe swallowing difficulties, not behavioral issues.° He did not refuse to
take his medication on August 14, for example. According to the note written by Nurse
Kimberly Jacobson, R17 took his pills “with much difficulty,” but refused to take the

® For this reason I finding unconvincing, at best, and deeply disturbing, at worst, Director
of Nursing (DON) Heather Foster’s claim that not one of her staff members ever reported
that R17 had a physical problem swallowing medication. P. Ex. 24 at 3 (Foster Decl.).
Moreover, none of the testimony from Petitioner’s nursing staff that describes R17’s
behavior problems is from the nurses who documented R17’s trouble swallowing
medication between August 9 and August 29, 2010.
10

pills with applesauce or anything else “to aid with swallowing.” CMS Ex. 6 at 50
(emphasis added). From this, I can reasonably infer that he was having trouble
swallowing his pills.

On August 15, Nurse Jacobson again reported that R17 “took a significant time to
swallow each individual pill with difficulty.” CMS Ex. 6 at 50. She directed him to
“focus on swallowing,” but noted that he was “forgetful” and, again, would not allow the
pills to be crushed or taken with applesauce “to assist with swallowing.” CMS Ex. 6 at
50. The progress note plainly describes another instance — the second in two days — of
R17 having “difficulty” swallowing his medication. The nurse wrote that staff would
“continue to monitor for comfort and safety.” CMS Ex. 6 at 50.

Less than one week later, on August 21, Nurse O’Donnell reported that R17 was having
“difficulty swallowing pills, pocketing them inside of cheek.” CMS Ex. 6, at 52. This
time he allowed her to add the whole pills to applesauce, which she described as “helpful
in assisting with swallowing.” CMS Ex. 6 at 52 (emphasis added); P. Ex. 7 at 33. Again,
nothing in the progress note suggests that he was refusing to take the pills or exhibiting
any other behavioral problem. The nurse wrote that staff would “continue to monitor.”

Petitioner also questions whether difficulty swallowing pills bears any relationship to
difficulty swallowing food. First, at least one nurse suggested that R17 had problems
with his pills because he was forgetting how to swallow, which would evidence a very
serious problem and require further assessment. CMS Ex. 6 at 50. Second, an adequate
assessment could have shown whether his difficulties were as limited as Petitioner now
suggests. Finally, R17’s inability to swallow apple slices on August 12, by itself, should
immediately have alerted staff to his potentially serious swallowing problems and
triggered a serious reassessment pursuant to the facility’s abuse prohibition policy.

I recognize that nursing staff checked and recorded R17’s vital signs at least once
following the August 12 incident. I also recognize that some of his nurses gave him
additional time to swallow his medications. P. Ex. 7 at 30-33. I do not consider these
acceptable substitutes for a qualified therapist assessing thoroughly the degree of his
impairment and proposing appropriate treatment. Nor do I consider these “interventions”
acceptable substitutes for proper monitoring in order to keep him safe while he ate.

The facility’s limited — and inadequate — response to R17’s swallowing problems: 1)
medication change. As noted above, following the August 12 choking incident, Nurse
O’Donnell left a message with PA Islamovic, who subsequently adjusted R17’s
medications. Whether the physician’s assistant communicated directly with anyone from
the facility is far from clear, but, in a telephone order, she reduced the resident’s
Oxycontin dosage. CMS Ex. 6 at 49. According to the medical literature, overusing
medications that affect a resident’s alertness may exacerbate swallowing difficulties, so
the medication change made some sense. See, e.g., CMS Ex. 10 at 3-5; CMS Ex. 11 at

11

14; CMS Ex. 12 at 2-4; P. Ex. 18 at 4. But no evidence suggests that SLP Marttila or any
qualified person subsequently assessed R17’s abilities to swallow. Indeed, no one even
told SLP Marttila about the August 12 incident, which staff certainly should have done.
Unless competent staff assessed and monitored the resident’s swallowing following the
medication change, the facility would not learn whether his swallowing difficulties were
related to his medications. More important, staff knew that R17 had experienced two
significant swallowing incidents and that he continued to have problems swallowing his
medications. They did not know why, and, without carefully monitoring R17 while he
ate, they could not guarantee his safety.

2) Nutrition-at-Risk Committee. For reasons unrelated to swallowing (abnormal lab
values and pressure ulcers), R17 had been referred to the Nutrition-at-Risk Committee.
The committee reviewed his status bi-weekly. CMS Ex. 6 at 37, 65, 66; P. Ex. 19 at 2
(Goulas Decl.).

On August 16, 2010, the committee, made up of RD Goulas and a nurse, completed a
one-page document, titled “Nutrition-At-Risk Communication Form.” The document
focuses on other issues (wounds, weight gain possibly related to edema), but mentions
that the resident “is supervised at meals” secondary to “recent choking episodes on
apples.” An undated addendum reiterates: “watching resident while in room” with meals
every shift. CMS Ex. 6 at 37. However, R17’s care plan does not include any instruction
that staff supervise him during his meals, and the record does not reflect when the facility
implemented that supervision or the means by which it instructed staff to supervise him.
See P. Ex. 5. Indeed, RN Shauna Bumford testified that staff did not supervise R17 while
he ate. P. Ex. 18 at 5 (Bumford Decl.). As evidenced by the August 12 incident, R17’s
choking death on August 29 (see discussion below), and the absence of evidence that
staff ever remained with him while he ate, I conclude that they were not supervising him.
He choked on his food three times (August 9, August 12, and August 29), and, each time,
no one was with him when he started to choke.

The form includes a checklist of recommendations for follow-up. Only one box is
checked — that the resident be weighed weekly. CMS Ex. 6 at 37. Other boxes, including
medical evaluation and speech pathology consult, are left blank. The Board has
suggested that the absence of a check mark “might be read as indicating that each of the
listed actions was considered and only the checked ones were chosen to be
implemented.” Hanover Hill Health Care Ctr., DAB No. 2507 at 16.

An unchecked box seems a tenuous thread by which to hang a finding of substantial
compliance. Indeed, in Brenham Nursing and Rehabilitation Center, DAB No. 2619
(2015), a box was checked, but the Board recognized — correctly — that checking, or not
checking, a box has little significance in the absence of underlying evidence:
12

The report’s bare statement that there was an “evaluation for
possible cause,” absent more information about the content
and extent of that evaluation, is not evidence of an
investigation at all, much less a thorough one. Moreover, the
ALJ reasonably concluded Brenham did not rule out the
possibility of abuse or neglect, notwithstanding someone’s
having put a check mark in the “No” box.

DAB No. 2619 at 11.

Significantly, Petitioner did not suggest that the absence of a check mark on this form
was significant in any way. Petitioner argues that RD Goulas and PA Islamovic
exercised their “professional judgment” by not assessing R17 or asking that R17 be re-
assessed. P. Post-Hr’g Br. at 14. Certainly, the record shows that no one performed a
meaningful assessment of R17’s swallowing ability following the August 12 incident or
any time thereafter. Beyond that, no reliable evidence suggests that the committee, or
anyone else, seriously considered or discussed whether they should refer R17 for another
assessment in light of the August 12 choking incident and his ongoing difficulties
swallowing his medications. To the contrary, RD Goulas concedes that she did not
consider referring R17 for an assessment. She justifies that failure by denying that R17
choked on the apple slices in the first place, claiming that she “saw no evidence of
dysphagia or swallowing difficulty.” P. Ex. 19 at 2, 3 (Goulas Decl.). In light the
written record and RD Goulas’s contemporaneous notes, I have found this claim not
credible (see discussion above). Moreover, inasmuch as coughing while eating can be a
sign of dysphagia, she should have recognized evidence of dysphagia.

From this, I conclude that, notwithstanding the existence of an unchecked box on a
standard form, the Nutrition-at-Risk Committee did not seriously consider R17’s need for
a swallowing assessment.

3) Malnutrition Risk Assessment. On August 24, 2010, Nurse O’Donnell completed a
document titled “Malnutrition Risk Assessment.” CMS Ex. 6 at 43. The document
reflects three notable changes: 1) R17’s “assessment score,” which is used to determine a
resident’s level of risk for malnutrition, nearly doubled, from 7 on July 8 to 13 on August
24; 2) R17’s mental status deteriorated from “alert-oriented x 3” (i.e., oriented to person,
place, and time) to “lethargic-disoriented x 2”; and 3) R17 had an additional risk factor,
“difficulty swallowing/frequent choking.” Compare CMS Ex. 6 at 65 with CMS Ex. 6 at
43. According to the facility’s policies, the Nutrition-at-Risk Committee should have
discussed these specific issues. CMS Ex. 5 at 2 (directing the committee to discuss
changes in status for any resident who scores 10 or above on the malnutrition risk

13

assessment). But, as noted above, the committee effectively disregarded the
deterioration.’

Petitioner has not claimed that the designated committee addressed these new issues, but
instead it attacks the validity of the August 24 document. In remarkable testimony, the
facility’s administrator, Lori McIntire, and Director of Nursing (DON) Heather Foster
claim that R17’s “malnutrition risk assessment” inaccurately describes R17’s “difficulty
swallowing/frequent choking.” P. Ex. 24 at 3 (Foster Decl.); CMS Ex. 6 at 43.
According to DON Foster, “the software that generates this form automatically enters
that language when the nurse completing the assessment enters any episode of choking
....” P. Ex. 24 at 3 (Foster Decl.).

These claims are belied by the medical record, with its documented incidents of
swallowing problems and choking. Even the August 16 Nutrition-at-Risk
Communication Form refers to “recent choking episodes,” and that reference is hand-
written, not computer-generated. CMS Ex. 6 at 37. Moreover, a resident’s assessment is
supposed to be individualized and, it should go without saying, must accurately reflect
the resident’s actual condition. 42 C.F.R. § 483.20(b)(2)(ii). An inaccurate assessment
compromises the integrity of the resident’s care plan, because the care plan — which is
supposed to describe the “services to be furnished to attain or maintain the resident’s
highest practicable physical, mental, and psychosocial well-being as required under
[section] 483.25” — is based on the assessment. Basing a care plan on an inaccurate
assessment obviously puts the facility out of substantial compliance with the quality of
care regulation, 42 C.F.R. § 483.25, and would evidence a very serious deficiency.
Conversely, disregarding the assessment would also put the facility out of substantial
compliance and would evidence a very serious deficiency.

In accordance with its abuse/neglect prohibition policy and the regulatory standards, the
facility should have re-assessed R17’s ability to swallow to determine the care and
services he required and then to provide that care and those services. The policy does not
require a specific type of assessment, but instructs staff to “assess, care plan for, and
monitor” the resident when there is a situation that may lead to neglect. CMS Ex. 5 at
19-20.8 Not assessing the scope of a potential swallowing problem is likely to lead to

7 The assessment also indicates that the resident required verbal cues to feed himself.
That he was left alone with his food suggests that staff could not have been providing the
necessary cues.

® SLP Marttila testified that “elaborate swallowing studies” are not done after the
“occasional occurrence” of swallowing problems, and the policy does not require a
specific type of assessment. P. Ex. 25, at 2. However, the swallowing difficulties
exhibited here — at least five documented incidents in three weeks, and two in a matter of
three days — exceeded an “occasional occurrence.” Moreover, the problem is not that the
14

neglect because, without an accurate assessment, the facility could not know how to
address the potentially life-threatening medical problem.

Even more critical, because staff knew or should have known of R17’s vulnerability, they
were charged with keeping him safe. The Nutrition-at-Risk Committee may have
recognized as much, claiming that he was supervised while eating. In fact, he was not.

P. Ex. 18 at 5 (Bumford Decl.).

R17’s Death on August 29, 2010. On August 29, R17 died while eating crackers covered
in peanut butter. CMS Ex. 6 at 57; CMS Ex. 8 at 7. The contemporaneous nursing notes,
reports from the emergency responders, as well as the resident’s death certificate all
describe his choking to death on peanut butter and crackers. We know that he had been
left alone because LPN Judith Ballentine writes that he called as she was passing his
room. He was coughing, had difficulty speaking, and “appeared to be choking.” She
attempted the Heimlich maneuver, removing a piece of peanut butter, and he started
coughing again. He spoke but “appeared to have difficulty catching his breath.” She
attempted the Heimlich a second time, “with no effect.” He became unresponsive, “no
breath noted.” CMS Ex. 6 at 57.

Staff told the responding paramedics that the resident liked peanut butter and had a
history of “shoveling peanut butter in his mouth.” The paramedics reported that he
“started choking” while eating it. His airway was obstructed by peanut butter, and they
removed a large amount of it but were unable to suction successfully because of the
“thickness of the peanut butter.” CMS Ex. 6 at 122. According to the death certificate,
R17 died from “asphyxia” and “upper airway obstruction by food.” CMS Ex. 8, at 1; see
CMS Ex. 6 at 29 (‘Pt. was stuffing peanut butter in his mouth when he started to
choke.”).

Citing the testimony of Howard Suls, M.D., who was R17’s physician and the facility’s
medical director, the facility maintains that R17 died, not from choking on peanut butter,
but from a cardiac event that just happened to coincide with his eating (but not
swallowing) a lot of peanut butter on crackers. P. Ex. 28 at 3-4. I find this highly
unlikely based on all of the contemporaneous evidence. Nevertheless, this case does not
rest on whether R17 choked to death on peanut butter and crackers. The facility was not
in substantial compliance because, contrary to the requirements of the regulations and its
own policies, it failed to assess properly and care-plan appropriately for R17 after he
demonstrated repeatedly that he was experiencing difficulties swallowing. To the extent
that they had a plan, it required that staff supervise him while he ate. But see P. Ex. 18 at

facility failed to provide an “elaborate swallowing study,” but that it did not assess R17’s
swallowing in any meaningful way after August 9, 2010, despite additional occurrences
of swallowing difficulty.
15

5 (Bumford Decl.) (denying that staff supervised R17 while he ate). Instead, they left
him alone with his food.

August 17 Review by Dr. Suls. Petitioner argues that Dr. Suls assessed R17 on August
17 and determined that the resident did not have swallowing issues that called for further
assessment or intervention. I found Dr. Suls’ testimony overall to be equivocal and not
credible. He testified that he decided no intervention was necessary, based on the
information he had, but he could not recall what information he had. Transcript (Tr.) 23.

e When asked, on cross-examination, whether he reviewed the progress note about
the August 14 instance of difficulty swallowing medication, Dr. Suls stated that “I
don’t recall if I did, but I won’t say that I didn’t either.” Tr. 17.

e When asked whether he was aware of either the August 15 or August 21 instance
of swallowing problems, Dr. Suls testified that “I can’t say that I was, but I can’t
say that I wasn’t.” Tr. 18.

e When asked whether he reviewed the relevant medical records pertaining to R17’s
swallowing difficulty, he replied “I cannot specifically recall.” Tr. 23.

On redirect examination, he testified that he made his decision based on SLP Marttila’s
August 9 assessment.

Q: [D]o you have a recollection that you, in fact, did make a
professional judgment at some point that no intervention for that [the
August 9 choking incident] was necessary?

A: 1-1 made the decision, as you said, that no intervention was
necessary, based on the information I had.

Q: All right. And what caused you to draw that conclusion or
make that professional judgment?

A: The fact that [R17] had been seen essentially immediately by
the speech therapist in the building and felt it had no clinical
evidence of any kind of swallowing disorder.

Q: And is that a professional judgment that, in your ordinary
course of medical practice you would rely upon in making your own
conclusions and judgments?

A: Yes it is. These are — this — these consultants are my experts
and I rely on them.
16

Q: And did you do so in this case?
A: I did so.

Tr. 23-24. I find two significant problems with Dr. Suls’ testimony. First, he
mischaracterizes SLP Marttila’s assessment. As he later conceded, she performed a
quick evaluation, thought the choking was probably an isolated event, which is what she
reported, but also said that staff should keep an eye on the resident and (presumably) let
er know if additional problems arose. Tr. 28; CMS Ex. 6 at 47. Second, Dr. Suls could
not say that, in reaching his conclusion, he considered any of the post-August 9 incidents
of R17’s trouble swallowing, from which I conclude that he did not. At best, he based his
decision on incomplete information.

Based on all of this, I conclude that the facility was not in substantial compliance with 42
C.F.R. § 483.13(c), the regulation aimed at prohibiting abuse and neglect. As I have
already said, the regulation is couched in terms of the facility’s having effective policies
to prevent neglect, but its drafters left no doubt that “inherent” in the regulation is the
requirement that residents be free from neglect and other forms of mistreatment. 59 Fed.
Reg. 56,130 (Nov. 10, 1994). A facility with acceptable written policies violates the
regulation if its staff does not carry out those policies. The Board has concluded that
examples of staff neglect can demonstrate that the facility has not implemented its
policies and is therefore out of substantial compliance with 42 C.F.R. § 483.13(c). See
discussion above for case citations. Here, as the above discussion illustrates, the
evidence establishes multiple examples of staff ignoring R17’s serious medical problem,
which led to neglect. Most important, they knew, or should have known, that his ability
to swallow was deteriorating and that he was at risk of choking. According to the
Nutrition-at-Risk Committee report, because of the choking episodes staff supervised him
at meals (although I could find no instructions to staff as to the specifics of that
supervision). Certainly, to keep him safe and free from neglect, staff should have been
supervising him when he ate. But no one was supervising him on August 12, when he
choked on apples. No one was supervising him on August 29, when he was left alone
with peanut butter and crackers. I consider this neglect.

That the facility amended his care plan to give him extra time to swallow his pills (P. Ex.
7 at 31) may have addressed his risk of choking on or not being able to take his pills, but
it did nothing to keep him safe while he was eating.

Also as noted above, the August 12 choking incident — particularly when coupled with
the mounting evidence that R17 could no longer swallow his medications easily — cast
significant doubt on SLP Marttila’s initial impression that his inability to swallow his
food on August 9 represented a single isolated incident. Yet, the facility continued to
rely on that outdated assessment. See, e.g., Tr. 23-24; P. Ex. 18 at 4 (testimony of Nurse
17

Bumford, stating “I personally did not consider another such assessment necessary [on
August 12] since the [SLP] had assessed [R17] only a few days earlier and found no
swallowing problem.”).

Facility policies compelled staff to “make every effort” to prevent resident neglect. They
were instructed to “identify, correct and intervene in situations in which... neglect...
was] more likely to occur” and to assess, care plan for, and monitor residents with needs
and behaviors that could lead to neglect. CMS Ex. 5 at 19-20. Yet, following the August
12 incident, no therapist or other qualified person assessed the degree of R17’s
swallowing impairment, much less proposed treatment based on that updated assessment.
Although one nurse speculated that his swallowing problems might have been caused by
is medication, which was subsequently decreased, no evidence suggests any follow-up
assessments to determine whether the medication change affected his ability to swallow.

Facility policy also dictated that members of the Nutrition-at-Risk Committee address the
changes in his swallowing abilities, which neither member of that committee claims to
ave done. CMS Ex. 5 at 2. In fact, RD Goulas has maintained that she did not have to
address R17’s swallowing issues because she “saw no evidence of dysphagia or
swallowing difficulty.” P. Ex. 19 at 2,3. But the record is replete with examples of R17
displaying symptoms of dysphagia: choking while eating or drinking, as R17 did on
August 9, 2010, is a sign of dysphagia; coughing before, during, or after swallowing, as
R17 did on August 12, is a sign of dysphagia; difficulty swallowing, as R17 displayed on
August 14 and August 15, is a sign of dysphagia. Retention of food or medication in the
mouth, as R17 did on August 21, is a sign of dysphagia. See CMS Ex. 9 at 2 (Kayser-
Jones and Pengilly, 20 Geriatric Nursing at 79, Tbl. 2, listing the “signs and symptoms of
dysphagia”). Because staff did not follow the facility’s policies for preventing neglect,
the facility was not in substantial compliance with 42 C.F.R. § 483.13(c).

For similar reasons the facility was not in substantial compliance with 42 C.F.R.

§ 483.25, the quality-of-care regulation. To be safe and achieve the highest practicable
well-being, R17 needed to be supervised while eating. He was not. When mounting
evidence established that his swallowing problems were more serious than a single,
isolated occurrence, he needed a professional assessment and treatment plan so that he
could attain his highest practicable level of well-being. The facility did not provide that
assessment or adequately plan for his care based on an up-to-date and accurate
assessment. Instead, the facility continued to rely on the out-of-date August 9 assessment
to justify its failure to identify and provide the care and services he needed. For this
reason, the facility was not in substantial compliance with 42 C.F.R. § 483.25. See
Spring Meadows, DAB No. 1966 at 16 (“The statute and the regulations as a whole are
based on the premise that the facility has (or can contract for) the expertise to first assess
what each resident’s needs are (in order to attain or maintain the resident’s highest
practicable functional level) and then to plan for and provide care and services to meet
the goal.”).

18

B. The penalty imposed is reasonable.

To determine whether a CMP is reasonable, I apply the factors listed in 42 C.F.R.

§ 488.438(f): (1) the facility’s history of noncompliance; (2) the facility’s financial
condition; (3) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of
culpability, which includes neglect, indifference, or disregard for resident care, comfort
or safety. The absence of culpability is not a mitigating factor. The factors in 42 C.F.R.
§ 488.404 include: (1) the scope and severity of the deficiency; (2) the relationship of the
deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior
istory of noncompliance in general and specifically with reference to the cited
deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a
level reasonably related to an effort to produce corrective action by a provider with the
ind of deficiencies found, and in light of the section 488.438(f) factors. I am neither
bound to defer to CMS’s factual assertions nor free to make a wholly independent choice
of remedies without regard for CMS’s discretion. Barn Hill Care Ctr., DAB No. 1848, at
21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22 et seg. (2002); Emerald Oaks,
DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

Here, CMS imposed a penalty of $7,500 per-instance, which is in the middle-to-higher
range for a per-instance CMP ($1,000-$10,000) and is modest considering what CMS
might have imposed. 42 C.F.R. § 488.408(e)(1)(iv); see Plum City Care Ctr., DAB No.
2272 at 18-19 (2009) (observing that even a $10,000 per-instance CMP can be “‘a modest
penalty when compared to what CMS might have imposed”).

Petitioner does not claim that its financial condition affects its ability to pay this
relatively small CMP.

The facility has a significant history of substantial noncompliance. In 9 out of 10 surveys
since 2001, CMS has found substantial noncompliance. “Quality of care” (42 C.F.R.
§ 483.25) deficiencies have been cited repeatedly. CMS Ex. 4. For example:

e In 2001, the facility was not in substantial compliance with “resident assessment”
(Tags F-282 and F-279) and “quality of care” requirements (Tag F-316); the
deficiencies were isolated but with a potential for more than minimal harm;

e In 2003, the facility was not in substantial compliance with “quality of care”
requirements (Tags F-309 and F-324), and its deficiencies caused actual harm; it
was not in substantial compliance with “resident assessment” requirements (Tag
F-281), and those deficiencies were widespread with a potential for more than
minimal harm;
19

e In 2004, the facility was not in substantial compliance with “quality of care”
requirements (Tag F-316); the deficiencies were isolated with the potential for
more than minimal harm;

e In 2006, the facility was not in substantial compliance with the requirements

governing “staff treatment of residents” (Tags F-225 and F-226); CMS found a
pattern of noncompliance with the potential for more than minimal harm; the
facility was not in substantial compliance with “quality of care” requirements (Tag
F-309); those deficiencies were isolated but caused actual harm;

e In 2007, the facility was not in substantial compliance with the requirements for
“comprehensive assessments” (Tag F-272), and those deficiencies were isolated
but with the potential for more than minimal harm; and

e In 2008, the facility was not in substantial compliance requirements governing
“staff treatment of residents” (Tag F-226); those deficiencies were isolated with a
potential for more than minimal harm. CMS Ex. 4, at 2-5.

The facility history alone justifies the relatively low penalty.

With respect to the remaining factors, multiple staff did not recognize or chose to ignore
symptoms of a potentially serious condition — the inability to swallow — which put the
resident in immediate jeopardy. The facility is culpable for their inaction.

For these reasons, | find that the $7,500 per-instance CMP is reasonable.
IV. Conclusion
For the reasons set forth above, Petitioner was not in substantial compliance with

Medicare participation requirements, 42 C.F.R. §§ 483.13(c) and 483.25. The relatively
small penalty imposed — $7,500 per-instance — is reasonable.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of H:

ealth and Human Services

DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,

(FDA No.

FDA-2015-H-0378)

Complainant

Vv.

Citi Deli L-L.C. / Ahmed Hassaballa

d/b/a Citi

Deli and Grocery,

Respondent.

Docket No. C-15-1210

Decision No. CR3744

Date:

April 7, 2015

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP)

began this matter by serving an administrative

complaint on Respondent, Citi Deli L.L.C./Ahmed Hassaballa d/b/a Citi Deli and
Grocery, at 1528 Monroe Avenue, Neptune, New Jersey 07753, and by filing a copy of

the complaint with the Food and Drug A
Management. The complaint alleges tha
cigarettes to minors and failed to verify,

dministration’s (FDA) Division of Dockets
t Citi Deli and Grocery impermissibly sold
by means of photo identification containing a

date of birth, that the purchasers were 18 years of age or older, 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 $500 civil money

penalty against Respondent Citi Deli and

Grocery.

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on February 11, 2015, CTP served the
complaint on Respondent Citi Deli and Grocery by United Parcel Service. In the
complaint and accompanying cover letter, CTP explained that, within 30 days,
Respondent should pay the penalty, file an answer, or request an extension of time in
which to file an answer. CTP warned Respondent that, if it failed to take one of these
actions within 30 days, the Administrative Law Judge could, pursuant to 21 C.F.R.
§ 17.11, issue an initial decision ordering it to pay the full amount of the proposed

penalty.

Respondent Citi Deli and Grocery has neither filed an answer within the time prescribed,
nor requested an extension of time within which to file an answer. Pursuant to 21 C.F.R.
§ 17.11, Lassume that the facts alleged in the complaint (but not its conclusory

statements) are true. Specifically:

At approximately 11:05 a.m. on June 20, 2013, at Respondent’s business
establishment, 1528 Monroe Avenue, Neptune, New Jersey 07753, an FDA-
commissioned inspector observed Respondent’s staff selling a package of
Marlboro cigarettes to a person younger than 18 years of age. The inspector also
observed that staff failed to verify, by means of photographic identification
containing a date of birth, that the purchaser was 18 years of age or older;

In a warning letter dated July 18, 2013, CTP informed Respondent of the
inspector’s June 20, 2013 observations, and that such actions violate federal law,
21 C.F.R. § 1140.14(a) and (b)(1). The letter further warned that Respondent’s
failure to correct its violations could result in a civil money penalty or other
regulatory action;

At approximately 12:24 p.m. on August 28, 2014, at Respondent’s business
establishment, 1528 Monroe Avenue, Neptune, New Jersey 07753, FDA-
commissioned inspectors documented Respondent’s staff selling a package of
Newport Box 100s cigarettes to a person younger than 18 years of age. The
inspectors also documented that staff failed to verify, by means of photographic
identification containing a date of birth, that the purchaser was 18 years of age or
older.

These facts establish Respondent Citi Deli and Grocery’s liability under the Act. The Act
prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is
misbranded if sold or distributed in violation of regulations issued under section 906(d)
of the Act. 21 U.S.C. § 387f(d); see 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. § 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010). Under 21
C.F.R. § 1140.14(a), no retailer may sell cigarettes to any person younger than 18 years
of age.
Under 21 C.F.R. § 1140.14(b)(1), retailers must verify, by means of photographic
identification containing a purchaser’s date of birth, that no cigarette purchasers are
younger than 18 years of age.

A $500 civil money penalty is permissible under 21 C.F.R. § 17.2.
Order

For these reasons, I enter default judgment in the amount of $500 against Respondent Citi
Deli L.L.C./Ahmed Hassaballa d/b/a Citi Deli and Grocery. Pursuant to 21 C.F.R.

§ 17.11(b), this order becomes final and binding upon both parties after 30 days of the
date of its issuance.

/s/
Catherine Ravinski
Administrative Law Judge


The Center fo’
complaint on

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,

(FDA No. FDA-2015-H-0433)
Complainant
v.

Mantaj Petroleum Inc. / Maria Singh
d/b/a Fast Break Marathon,

Respondent.
Docket No. C-15-1267
Decision No. CR3743

Date: April 15, 2015

INITIAL DECISION AND DEFAULT JUDGMENT

r Tobacco Products (CTP) began this matter by serving an administrative
Respondent, Mantaj Petroleum Inc. / Maria Singh d/b/a Fast Break

Marathon, at 616 West Maumee Street, Angola, Indiana 46703, and by filing a copy of

the complaint
Management.

with the Food and Drug Administration’s (FDA) Division of Dockets
The complaint alleges that Fast Break Marathon impermissibly sold

smokeless tobacco to minors and failed to verify, by means of photo identification
containing a date of birth, that the purchasers were 18 years of age or older, thereby

violating the
its implement:

Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and
ing regulations, 21 C.F.R. pt. 1140. CTP seeks to impose a $500 civil

money penalty against Respondent Fast Break Marathon.

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on February 19, 2015, CTP served the

complaint on

Respondent Fast Break Marathon by United Parcel Service. In the

complaint and accompanying cover letter, CTP explained that, within 30 days,

Respondent s!

ould pay the penalty, file an answer, or request an extension of time in
which to file an answer. CTP warned Respondent that, if it failed to take one of these
actions within 30 days, the Administrative Law Judge could, pursuant to 21 C.F.R.

§ 17.11, issue an initial decision ordering it to pay the full amount of the proposed
penalty.

Respondent Fast Break Marathon has neither filed an answer within the time prescribed,
nor requested an extension of time within which to file an answer. Pursuant to 21 C.F.R.
§ 17.11, Lassume that the facts alleged in the complaint (but not its conclusory
statements) are true. Specifically:

e At approximately 1:56 p.m. on March 29, 2014, at Respondent’s business
establishment, 616 West Maumee Street, Angola, Indiana 46703, an
FDA-commissioned inspector observed Respondent’s staff selling a package of
Grizzly Long Cut Premium Wintergreen smokeless tobacco to a person younger
than 18 years of age. The inspector also observed that staff failed to verify, by
means of photographic identification containing a date of birth, that the purchaser
was 18 years of age or older;

e Ina warning letter dated May 29, 2014, CTP informed Respondent of the
inspector’s March 29, 2014 observations, and that such actions violate federal law,
21 C.F.R. § 1140.14(a) and (b)(1). The letter further warned that Respondent’s
failure to correct its violations could result in a civil money penalty or other
regulatory action;

e At approximately 6:55 p.m. on September 17, 2014, at Respondent’s business
establishment, 616 West Maumee Street, Angola, Indiana 46703,
FDA-commissioned inspectors documented Respondent’s staff selling a package
of Grizzly Long Cut Premium Wintergreen smokeless tobacco to a person younger
than 18 years of age. The inspectors also documented that staff failed to verify, by
means of photographic identification containing a date of birth, that the purchaser
was 18 years of age or older.

These facts establish Respondent Fast Break Marathon’s liability under the Act. The Act
prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is
misbranded if sold or distributed in violation of regulations issued under section 906(d)
of the Act. 21 U.S.C. § 387f(d); see 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. § 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010).
Under 21 C.F.R. § 1140.14(a), no retailer may sell smokeless tobacco to any person
younger than 18 years of age. Under 21 C.F.R. § 1140.14(b)(1), retailers must verify, by
means of photographic identification containing a purchaser’s date of birth, that no
smokeless tobacco purchasers are younger than 18 years of age.

A $500 civil money penalty is permissible under 21 C.F.R. § 17.2.
Order

For these reasons, I enter default judgment in the amount of $500 against Respondent
Mantaj Petroleum Inc. / Maria Singh d/b/a Fast Break Marathon. Pursuant to 21 C.F.R.
§ 17.11(b), this order becomes final and binding upon both parties after 30 days of the
date of its issuance.

/s/
Catherine Ravinski
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
AR Testing Corp.,
(PTAN: A300001784),
Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-15-54
Decision No. CR3741

Date: March 30, 2015

DECISION

Petitioner, AR Testing Corp., is an independent diagnostic testing facility (IDTF) located
in Deer Park, New York, that, until recently, was enrolled in the Medicare program. The
Centers for Medicare & Medicaid Services (CMS) found that Petitioner is no longer
operational and revoked its Medicare supplier number. Petitioner challenged the
revocation, and, in a reconsidered determination dated August 8, 2014, the Medicare
contractor upheld the revocation. Petitioner appeals and CMS have moved for summary
judgment.

For the reasons set forth below, I find that this case presents no genuine dispute of
material fact and that CMS is entitled to judgment as a matter of law. I agree that
Petitioner did not meet the requirements for an IDTF and was not operational. I therefore
grant CMS’s motion for summary judgment.
Background

Until February 12, 2014, Petitioner was enrolled in the Medicare program as an IDTF.
See 42 C.F.R. § 410.33. Ina letter dated March 19, 2014, the Medicare contractor,
National Government Services, notified Petitioner that its Medicare privileges were
revoked and its provider agreement terminated, effective February 12, 2014. According
to the letter, the contractor took this action pursuant to 42 C.F.R. § 424.535(a)(5)
because, based on a February 12, 2014 site visit, the business was no longer operational.
The letter also claims that the supplier failed to report its change in practice location
within 30 days, as required by 42 C.F.R. § 424.535(a)(9).' CMS Ex. 2.

Petitioner sought reconsideration. In a reconsidered determination, dated August 8, 2014,
the contractor upheld the revocation, concluding that the IDTF was no longer operational
and had failed to report, within 30 days, any change of location.” CMS Ex. 5. Petitioner
now appeals that determination pursuant to 42 C.F.R. § 424.545.

CMS moved for summary judgment. With its memorandum in support (CMS Br.), it
submits 5 exhibits (CMS Exs. 1-5). Petitioner submits it brief (P. Br.) and 12 exhibits (P.
Exs. 1-12).

Discussion

CMS is entitled to summary judgment because undisputed evidence
establishes that the Petitioner was not operational at its registered
practice location, and CMS therefore properly revoked its Medicare
enrollment.

Summary Judgment. To grant summary judgment, I must draw all reasonable inferences
in the light most favorable to the non-moving party and find that the case presents no
genuine issues of material fact and that the moving party is entitled to judgment as a
matter of law. 1866/CPayday.com, L.L.C., DAB No. 2289, at 2-3 (2009); I/inois
Knights Templar Home, DAB No. 2274, at 3-4 (2009), and cases cited therein.

' Apparently in error, the letter refers to 42 C.F.R. § 424.516(d)(ii), which governs the
obligation of a physician, nonphysician practitioner, and their organizations to report any
adverse legal action. The reporting obligations for IDTFs are set forth at 42 C.F.R.

§ 410.33(g)(2).

> The reconsidered determination also cited the wrong reporting regulation, citing 42
C.F.R. § 424.516(d)(ii) rather than 42 C.F.R. § 410.33(g)(2).

> T make this one finding of fact/conclusion of law.
Program requirements. Medicare will pay for diagnostic procedures performed by
an IDTF. An IDTF may be a fixed location, a mobile entity, or an individual
nonphysician practitioner. 42 C.F.R. § 410.33(a)(1). Petitioner here is a mobile
IDTF. An IDTF, including a mobile IDTF, must maintain a physical facility on an
appropriate site and must permit CMS, including its agents or contractors, to
conduct unannounced, on-site inspections to confirm its compliance with IDTF
standards. It must be accessible during regular business hours to CMS and
beneficiaries and maintain a visible sign posting its normal business hours. 42
C.F.R. §§ 410.33(g)(3), (14). If the IDTF does not meet these (and other)
standards, CMS will revoke its billing privileges. 42 C.F.R. §§ 410.33(h),
424.535(a)(5).

CMS may also revoke the IDTF’s Medicare enrollment if it finds that the facility is no
longer operational to furnish Medicare-covered items or services. 42 C.F.R.

§ 424.535(a)(5). A supplier is “operational” if it has a qualified physical practice
location, is open to the public for the purpose of providing health care related services, is
prepared to submit valid Medicare claims, and is properly staffed, equipped, and stocked
to furnish those items or services. 42 C.F.R. § 424.502.

On February 12, 2014, Petitioner’s practice location was 1640 Deer Park Avenue, Deer
Park, New York. P. Ex. 12 at 1 (Sokol Decl. §2).* On that day, Anthony V. Campo, an
inspector for the Medicare contractor, went to the 1640 Deer Park address to inspect the
facility, arriving at 9:35 a.m. CMS Ex. | at 2 (Campo Decl. f§ 1, 2). According to
Inspector Campo, he was unable to find a sign identifying the facility and, in fact, was
not able to locate the facility at all, even after checking every office in the building. After
questioning someone from another office, he obtained the name and telephone number
for Scott Sokol, owner of AR Testing. CMS Ex. | at 2-3 (Campo Decl. ¥ 3). Later that
day, Inspector Campo and Owner Sokol spoke by telephone. CMS Ex. | at 3 (Campo
Decl. ] 6); P. Ex. 12 at 2 (Sokol Decl. 5-7) .

Petitioner concedes that no one was in the facility at 9:35 a.m. on February 12, 2014.
According to Owner Sokol, he stopped by 1640 Deer Park Avenue at 7:30 that morning
to pick up equipment, but left to go to a medical office in Queens, New York. P. Ex. 12
at 2 (Sokol Decl. § 4-5); Hearing Request at 4 § 19 (conceding “no person was available
to see walk-in patients at the time that the unannounced site visit occurred”). Petitioner
argues that the business was nevertheless “accessible” during regular business hours
because he and his technicians could be contacted by telephone, and the applicable
telephone numbers were posted on the facility’s sign. P. Ex. 12 at 11 (Sokol Decl. § 44).

* Although the facility was planning a move on March 31, 2014, according to Owner
Sokol, the Deer Park location was its practice location at the time Inspector Campo
visited. P. Ex. 12 at 5, 6 (Sokol Decl. J 22, 26).
Without citation to any authority, Petitioner maintains that a mobile IDTF need not have
its location attended and accessible to the general public. P. Br. at 8.

Petitioner’s position is not compatible with the regulations. An IDTF must be accessible
to CMS and beneficiaries during regular business hours. 42 C.F.R. § 410.33(g)(14). It is
not operational if it is not open to the public and properly staffed. 42 C.F.R. § 424.502.
Posting a telephone number does not satisfy the requirements that a supplier be open and
accessible. See Complete Home Care, DAB No. 2525, at 5-6 (2013). Moreover, CMS
must be able to conduct unannounced on-site inspections (42 C.F.R. § 410.33(g)(14)),
which it could not do if required to call facility staff in order to arrange access. See 76
Fed. Reg. 5862, 5869 (Feb. 2, 2011) (explaining that unannounced site visits to IDTFs
are important to protect against fraud and to ensure that the enrolled supplier remains
viable).

CMS also complains that no visible sign was posted, as required by 42 C.F.R.

§ 410.33(g)(14)(1i). In its request for hearing, Petitioner conceded that “at the time of the
visit,” construction workers “had very recently taken down AR Testing’s sign, and it had
not yet been replaced.” Hearing Request at 4 § 17. Now, however, Petitioner is less
definitive. Without declaring outright that a visible sign was posted, it maintains that
“AR Testing had signage on site.” P. Br. at 8. It submits undated photographs showing
what appear to be temporary signs. One sign, on an exterior door, has the facility name
on it. A second sign, next to the door, says that the office hours are Monday through
Friday, 9 a.m. to 5 p.m. and “By Appointment.”® P. Ex. 11 at 1, 2,3, 8. Owner Sokol
alludes to the signage, without specifically saying that any sign was posted on February
12: “As indicated on AR Testing’s signage, AR Testing was available by appointment
and could be contacted during regular business hours. Copies of photographs showing a
fair and accurate likeness of AR Testing’s entrance . . . are annexed as Exhibit 11.” P.
Ex. 12 at 11 (Sokol Decl. § 44).

Because I must draw all reasonable inferences in the light most favorable to the
nonmoving party, I accept, for summary judgment purposes, that the signs submitted as
P. Ex. 11 have been posted consistently at the facility’s entrance, including on February
12, but I find this not material. The undisputed evidence establishes that the facility was
not accessible for inspection during regular business hours and was not operational.
These undisputed findings are sufficient to justify revoking its Medicare supplier number.
See Centro Radiologico Rolon, Inc., DAB No. 2579, at 7 (2014) (Each violation
independently constitutes a basis upon which to sustain revocation).

> T note that the investigator’s photograph, taken on February 12, shows a significant
amount of snow on the ground, the shrubbery, and the building’s roof. CMS Ex. | at 8.
The snow seems to be missing from Petitioner’s photographs. P. Ex. 11 at 1, 2, 3.
Conclusion

Because the undisputed evidence establishes that Petitioner did not meet the requirements
for an IDTF and was not operational, CMS properly revoked its Medicare supplier
number. I therefore grant CMS’s motion for summary judgment.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
(FDA No. FDA-2015-H-0231)

Complainant
v.

Wellston Food Market, Inc. / Warrad A. Warrad
d/b/a Wellston Food Market,

Respondent.
Docket No. C-15-1055
Decision No. CR3737

Date: March 27, 2015

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) began this matter by serving an administrative
complaint on Respondent, Wellston Food Market, Inc. / Warrad A. Warrad d/b/a
Wellston Food Market, at 6250 Page Avenue, St. Louis, Missouri 63133, and by filing a
copy of the complaint with the Food and Drug Administration’s (FDA) Division of
Dockets Management. The complaint alleges that Wellston Food Market impermissibly
sold cigarettes to minors and failed to verify, by means of photo identification containing
a date of birth, that the purchasers were 18 years of age or older, 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 $500 civil money
penalty against Respondent Wellston Food Market.

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on January 29, 2015, CTP served the
complaint on Respondent Wellston Food Market by United Parcel Service. In the
complaint and accompanying cover letter, CTP explained that, within 30 days,
Respondent should pay the penalty, file an answer, or request an extension of time in

which to file an answer. CTP warned Respondent that, if it failed to take one of these
actions within 30 days, the Administrative Law Judge could, pursuant to 21 C.F.R.

§ 17.11, issue an initial decision ordering it to pay the full amount of the proposed
penalty.

Respondent Wellston Food Market has neither filed an answer within the time prescribed,
nor requested an extension of time within which to file an answer. Pursuant to 21 C.F.R.
§ 17.11, L assume that the facts alleged in the complaint (but not its conclusory
statements) are true. Specifically:

e At approximately 6:31 p.m. on June 6, 2013, at Respondent’s business
establishment, 6250 Page Avenue, St. Louis, Missouri 63133, an FDA-
commissioned inspector documented Respondent’s staff selling a package of
Newport Box cigarettes to a person younger than 18 years of age. The inspector
also documented that staff failed to verify, by means of photographic identification
containing a date of birth, that the purchaser was 18 years of age or older;

e Ina warning letter dated June 27, 2013, CTP informed Respondent of the
inspector’s June 6, 2013 observations, and that such actions violate federal law, 21
C.F.R. § 1140.14(a) and (b)(1). The letter further warned that Respondent’s
failure to correct its violations could result in a civil money penalty or other
regulatory action;

e At approximately 10:22 a.m. on June 11, 2014, at Respondent’s business
establishment, 6250 Page Avenue, St. Louis, Missouri 63133, FDA-commissioned
inspectors documented Respondent’s staff selling a package of Grizzly Long Cut
Premium Wintergreen smokeless tobacco to a person younger than 18 years of
age. The inspector also documented that staff failed to verify, by means of
photographic identification containing a date of birth, that the purchaser was 18
years of age or older.

These facts establish Respondent Wellston Food Market’s liability under the Act. The
Act prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product
is misbranded if sold or distributed in violation of regulations issued under section 906(d)
of the Act. 21 U.S.C. § 387f(d); see 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. § 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010). Under 21
C.F.R. § 1140.14(a), no retailer may sell cigarettes to any person younger than 18 years
of age.
Under 21 C.F.R. § 1140.14(b)(1), retailers must verify, by means of photographic
identification containing a purchaser’s date of birth, that no cigarette purchasers are
younger than 18 years of age.

A $500 civil money penalty is permissible under 21 C.F.R. § 17.2.
Order
For these reasons, I enter default judgment in the amount of $500 against Respondent

Wellston Food Market. Pursuant to 21 C.F.R. § 17.11(b), this order becomes final and
binding upon both parties after 30 days of the date of its issuance.

/s/
Catherine Ravinski
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
(FDA No. FDA-2015-H-0247)

Complainant
v.

Paola, LLC
d/b/a Smoker’s Stop Convenience,

Respondent.
Docket No. C-15-1072
Decision No. CR3736

Date: April 1, 2015

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) began this matter by serving an administrative
complaint on Respondent, Paola, LLC d/b/a Smoker’s Stop Convenience, at 206A
Dixwell Avenue, New Haven, Connecticut 06511, and by filing a copy of the complaint
with the Food and Drug Administration’s (FDA) Division of Dockets Management. The
complaint alleges that Smoker’s Stop Convenience impermissibly sold cigarettes to
minors and failed to verify, by means of photo identification containing a date of birth,
that the purchasers were 18 years of age or older, thereby violating the Federal Food,
Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seg., and its implementing regulations,
21 C.F.R. pt. 1140. CTP seeks to impose a $500 civil money penalty against Respondent
Smoker’s Stop Convenience.

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on January 29, 2015, CTP served the
complaint on Respondent Smoker’s Stop Convenience by United Parcel Service. In the
complaint and accompanying cover letter, CTP explained that, within 30 days,
Respondent should pay the penalty, file an answer, or request an extension of time in

which to file an answer. CTP warned Respondent that, if it failed to take one of these
actions within 30 days, the Administrative Law Judge could, pursuant to 21 C.F.R.

§ 17.11, issue an initial decision ordering it to pay the full amount of the proposed
penalty.

Respondent Smoker’s Stop Convenience has neither filed an answer within the time
prescribed, nor requested an extension of time within which to file an answer. Pursuant
to 21 C.F.R. § 17.11, Il assume that the facts alleged in the complaint (but not its
conclusory statements) are true. Specifically:

e At approximately 12:16 p.m. on February 28, 2014, at Respondent’s business
establishment, 206A Dixwell Avenue, New Haven, Connecticut 06511, an
FDA-commissioned inspector observed Respondent’s staff selling a package of
Camel Menthol Silver cigarettes to a person younger than 18 years of age. The
inspector also observed that staff failed to verify, by means of photographic
identification containing a date of birth, that the purchaser was 18 years of age or
older;

e Ina warning letter dated June 19, 2014, CTP informed Respondent of the
inspector’s February 28, 2014 observations, and that such actions violate federal
law, 21 C.F.R. § 1140.14(a) and (b)(1). The letter further warned that
Respondent’s failure to correct its violations could result in a civil money penalty
or other regulatory action;

e At approximately 11:21 a.m. on September 5, 2014, at Respondent’s business
establishment, 206A Dixwell Avenue, New Haven, Connecticut 06511,
FDA-commissioned inspectors documented Respondent’s staff selling a package
of Newport Box cigarettes to a person younger than 18 years of age. The
inspectors also documented that staff failed to verify, by means of photographic
identification containing a date of birth, that the purchaser was 18 years of age or
older.

These facts establish Respondent Smoker’s Stop Convenience’s liability under the Act.
The Act prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco
product is misbranded if sold or distributed in violation of regulations issued under
section 906(d) of the Act. 21 U.S.C. § 387f(d); see 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. § 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010). Under 21
C.F.R. § 1140.14(a), no retailer may sell cigarettes to any person younger than 18 years
of age.
Under 21 C.F.R. § 1140.14(b)(1), retailers must verify, by means of photographic
identification containing a purchaser’s date of birth, that no cigarette purchasers are
younger than 18 years of age.

A $500 civil money penalty is permissible under 21 C.F.R. § 17.2.
Order

For these reasons, I enter default judgment in the amount of $500 against Respondent
Paola, LLC d/b/a Smoker’s Stop Convenience. Pursuant to 21 C.F.R. § 17.11(b), this
order becomes final and binding upon both parties after 30 days of the date of its
issuance.

/s/
Catherine Ravinski
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
Complainant
v.

PSD Holdings, Inc. / Pavitter Dhaliwal
d/b/a Edmonds Liquor and Gas,

Respondent.

Docket No. C-15-1076
FDA Docket No. FDA-2015-H-0252

Decision No. CR3735

Date: March 27, 2015

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint)
against Respondent, PSD Holdings, Inc. / Pavitter Dhaliwal d/b/a Edmonds Liquor and
Gas, that alleges facts and legal authority sufficient to justify the imposition of a civil
money penalty of $500. Respondent did not answer the Complaint, nor did Respondent
request an extension of time within which to file an answer. Therefore, I enter a default
judgment against Respondent and assess a civil money penalty of $500.

CTP began this case by serving the Complaint on Respondent and filing a copy of the
Complaint with the Food and Drug Administration’s (FDA) Division of Dockets
Management. The Complaint alleges that Respondent impermissibly sold tobacco
products to minors and failed to verify that the tobacco purchasers were 18 years of age
or older, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.
§ 301 et seq., and its implementing regulations, Cigarettes and Smokeless Tobacco,

21 C.F.R. pt. 1140 (2013). CTP seeks a civil money penalty of $500.

On January 29, 2015, CTP served the Complaint on Respondent by United Parcel
Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7. In the Complaint and accompanying
cover letter, CTP explained that within 30 days, Respondent should pay the proposed
penalty, file an answer, or request an extension of time within which to file an answer.
CTP warned Respondent that if it failed to take one of these actions within 30 days, an
Administrative Law Judge could, pursuant to 21 C.F.R. § 17.11, issue an initial decision
ordering Respondent to pay the full amount of the proposed penalty.

Respondent has not filed an answer within the time provided by regulation, nor has it
requested an extension. Pursuant to 21 C.F.R. § 17.11(a), 1 am required to “assume the
facts alleged in the [C]omplaint to be true” and, if those facts establish liability under the
Act, issue a default judgment and impose a civil money penalty. Accordingly, I must
determine whether the allegations in the Complaint establish violations of the Act.

Specifically, CTP alleges the following facts in its Complaint:

e Respondent owns Edmonds Liquor and Gas, an establishment that sells tobacco
products and is located at 23726 100" Avenue West, Edmonds, Washington
98020. Complaint 3.

e During an inspection of Respondent’s establishment on March 20, 2014, at
approximately 3:41 PM, an FDA-commissioned inspector observed that “‘a person
younger than 18 years of age was able to purchase a package of Marlboro
cigarettes .. . [.]” The inspector also observed that “the minor’s identification was
not verified before the sale... .”” Complaint § 10.

e On May 22, 2014, CTP issued a Warning Letter to Respondent regarding the
inspector’s observations from March 20, 2014. The letter explained that the
observations constituted violations of regulations found at 21 C.F.R. § 1140.14(a)
and (b)(1), and that the named violations were 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 violations, 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 According to UPS records the Warning Letter was received on May 23, 2014, but
CTP did not receive a response to the Warning Letter. Complaint § 11.

e During a subsequent inspection of Respondent’s establishment on July 29, 2014,
at approximately 11:21 AM, FDA-commissioned inspectors documented that “a
person younger than 18 years of age was able to purchase a package of TOP
Superoll cigarette tobacco . . . [.]” The inspectors also documented that “the
minor’s identification was not verified before the sale... .” 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.

§ 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010). The regulations prohibit the
sale of cigarettes or smokeless tobacco to any person younger than 18 years of age.

21 C.F.R. § 1140.14(a). The regulations also require retailers to verify, by means of
photo identification containing a purchaser’s date of birth, that no cigarette or smokeless
tobacco purchasers are younger than 18 years of age. 21 C.F.R. § 1140.14(b)(1).

Taking the above alleged facts as true, Respondent violated the prohibition against selling
cigarettes or smokeless tobacco to persons younger than 18 years of age, 21 C.F.R.

§ 1140.14(a), on March 20, 2014, and July 29, 2014. On those same dates, Respondent
also violated the requirement that retailers verify, by means of photo identification
containing a purchaser’s date of birth, that no cigarette or smokeless tobacco purchasers
are younger than 18 years of age. 21 C.F.R. § 1140.14(b)(1). Therefore, Respondent’s
actions constitute violations of law that merit a civil money penalty.

CTP has requested a fine of $500, which is a permissible fine under the regulations.
21 C.F.R. § 17.2. Therefore, I find that a civil money penalty of $500 is warranted and so
order one imposed.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
(FDA No. FDA-2015-H-0222)

Complainant
v.

Grewal Corporation
d/b/a 7-Eleven 22398,

Respondent.
Docket No. C-15-1034
Decision No. CR3733

Date: March 30, 2015

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) began this matter by serving an administrative
complaint on Respondent, Grewal Corporation d/b/a 7-Eleven 22398, at 539 Pleasant
Street, Holyoke, Massachusetts 01040, and by filing a copy of the complaint with the
Food and Drug Administration’s (FDA) Division of Dockets Management. The
complaint alleges that 7-Eleven 22398 impermissibly sold cigarettes to minors and failed
to verify, by means of photo identification containing a date of birth, that the purchasers
were 18 years of age or older, thereby violating the Federal Food, Drug, and Cosmetic
Act (Act), 21 U.S.C. § 301 et seg., and its implementing regulations, 21 C.F.R. pt. 1140.
CTP seeks to impose a $5,000 civil money penalty against Respondent 7-Eleven 22398.

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on January 28, 2015, CTP served the
complaint on Respondent 7-Eleven 22398 by United Parcel Service. In the complaint
and accompanying cover letter, CTP explained that, within 30 days, Respondent should
pay the penalty, file an answer, or request an extension of time in which to file an answer.
CTP warned Respondent that, if it failed to take one of these actions within 30 days, the

Administrative Law Judge could, pursuant to 21 C.F.R. § 17.11, issue an initial decision
ordering it to pay the full amount of the proposed penalty.

Respondent 7-Eleven 22398 has neither filed an answer within the time prescribed, nor
requested an extension of time within which to file an answer. Pursuant to 21 C.F.R.

§ 17.11, Lassume that the facts alleged in the complaint (but not its conclusory
statements) are true. Specifically:

e CTP previously issued a warning letter to 7-Eleven 22398 on January 3, 2013,
citing a violation of 21 C.F.R. pt. 1140 on December 5, 2012, at Respondent’s
business establishment, 539 Pleasant Street, Holyoke, Massachusetts 01040.

e¢ On March 28, 2013, CTP initiated a previous civil money penalty action, CRD
Docket Number C-14-834, FDA Docket Number FDA-2014-H-0360, against
Respondent for three violations of 21 C.F.R. pt. 1140 within a twenty-four month
period. CTP alleged those violations to have occurred on December 5, 2012, and
October 22, 2013.

e The previous action concluded when Ms. Mohinder, Respondent’s authorized
representative, settled the claims on Respondent’s behalf. On April 25, 2014, Ms.
Mohinder signed an Acknowledgment Form in which she “admitted that the
violations. ..occurred, waiv[ed] her ability to contest the violations in the future,
and stat[ed] that she understood that the violations may be counted in determining
the total number of violations for purposes of future enforcement actions.” The
Administrative Law Judge closed the case on May 5, 2014.

e At approximately 1:56 PM on July 29, 2014, at Respondent’s business
establishment, 539 Pleasant Street, Holyoke, Massachusetts 01040, an
FDA-commissioned inspector observed Respondent’s staff selling a package of
Marlboro Gold Pack 100’s cigarettes to a person younger than 18 years of age.
The inspector also observed that staff failed to verify, by means of photographic
identification containing a date of birth, that the purchaser was 18 years of age or
older;

These facts establish Respondent 7-Eleven 22398’s liability under the Act. The Act
prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is
misbranded if sold or distributed in violation of regulations issued under section 906(d)
of the Act. 21 U.S.C. § 387f(d); see 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. § 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010). The
regulations prohibit the sale of tobacco products to any person younger than 18 years of
age. 21 C.F.R. § 1140.14(a).
The regulations also require retailers to verify, by means of photo identification
containing a purchaser’s date of birth, that no tobacco purchasers are younger than
18 years of age. 21 C.F.R. § 1140.14(b)(1).

A $5,000 civil money penalty is permissible under 21 C.F.R. § 17.2.
Order
For these reasons, | enter default judgment in the amount of $5,000 against Respondent

Grewal Corporation d/b/a 7-Eleven 22398. Pursuant to 21 C.F.R. § 17.11(b), this order
becomes final and binding upon both parties after 30 days of the date of its issuance.

/s/
Catherine Ravinski
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
(FDA No. FDA-2015-H-0220)

Complainant,
v.

Zu Rong Zou
d/b/a Grace Garden,

Respondent.
Docket No. C-15-1031
Decision No. CR3730

Date: March 27, 2015

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) began this matter by serving an administrative
complaint on Respondent, Zu Rong Zou d/b/a Grace Garden, at 5025 Germantown
Avenue, Philadelphia, Pennsylvania 19144, and by filing a copy of the complaint with the
Food and Drug Administration’s (FDA) Division of Dockets Management. The
complaint alleges that Grace Garden unlawfully sold tobacco products to minors and
failed to verify that a purchaser was 18 years of age or older, thereby violating the
Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its
implementing regulations, Cigarettes and Smokeless Tobacco, 21 C.F.R. pt. 1140. The
complaint likewise alleges that Respondent Grace Garden previously admitted to three
violations of regulations found at 21 C.F.R. pt. 1140 and, therefore, CTP seeks to impose
a $2,000 civil money penalty against Respondent Grace Garden.

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on January 28, 2015, CTP served the
complaint on Respondent Grace Garden by United Parcel Service. In the complaint and
accompanying cover letter, CTP explained that, within 30 days, Respondent should pay

the penalty, file an answer, or request an extension of time in which to file an answer.
CTP warned Respondent that, if it failed to take one of these actions within 30 days, the
Administrative Law Judge could, pursuant to 21 C.F.R.§ 17.11, issue an initial decision
ordering it to pay the full amount of the proposed penalty.

Respondent Grace Garden has neither filed an answer within the time prescribed, nor
requested an extension of time within which to file an answer. Pursuant to 21 C.F.R.
§ 17.11, Lassume that the facts alleged in the complaint (but not its conclusory
statements) are true. Specifically:

e CTP previously issued a warning letter to Respondent Grace Garden on September
15, 2011, citing violations of 21 C.F.R. pt. 1140 on June 6, 2011, at Respondent’s
business establishment, 5025 Germantown Avenue, Philadelphia, Pennsylvania
19144;

e On July 5, 2013, CTP initiated a previous civil money penalty action, CRD Docket
Number C-13-955, FDA Docket Number FDA-2013-H-1452, against Respondent
for three violations of 21 C.F.R. pt. 1140 within a twenty-four month period. CTP
alleged two of those violations to have occurred on December 31, 2012;

e The previous action concluded when Zu Rong Zou, Respondent’s authorized
representative, settled the claims on Respondent’s behalf. On September 16,
2013, Mr. Zou signed an Acknowledgment Form in which he “admitt[ed] that the
violations . . . occurred, waiv[ed] his ability to contest the violations in the future,
and stat[ed] that he understood that that violations may be counted in determining
the total number of violations for purposes of future enforcement actions.” The
Administrative Law Judge closed the case on October 18, 2013;

e At approximately 1:43 p.m. on August 11, 2014, at Respondent’s business
establishment, 5025 Germantown Avenue, Philadelphia, Pennsylvania 19144,
FDA-commissioned inspectors observed that a person younger than 18 years of
age was able to purchase a package of Newport Box 100s cigarettes. The
inspector also documented that staff failed to verify, by means of photographic
identification containing a date of birth, that the purchaser was 18 years of age or
older.

These facts establish Respondent Grace Garden’s liability under the Act. The Act
prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is
misbranded if sold or distributed in violation of regulations issued under section 906(d)
of the Act. 21 U.S.C. § 387f(d); see 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. § 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010).
The regulations prohibit the sale of tobacco products to any person younger than 18 years
of age. 21 C.F.R. § 1140.14(a). The regulations also require retailers to verify, by means
of photo identification containing a purchaser’s date of birth, that no tobacco purchasers
are younger than 18 years of age. 21 C.F.R. § 1140.14(b)(1).

A $2,000 civil money penalty is permissible under 21 C.F.R. § 17.2.

Order

For these reasons, | enter default judgment in the amount of $2,000 against Respondent
Zu Rong Zou d/b/a Grace Garden. Pursuant to 21 C.F.R. § 17.11(b), this order becomes
final and binding upon both parties after 30 days of the date of its issuance.

/s/
Catherine Ravinski
Administrative Law Judge