Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Premier Living and Rehab Center, ) Date: May 29, 2007

(CCN: 34-5185) )
)
Petitioner, )
)

-V.- ) Docket No. C-06-199

) Decision No. CR1602
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Premier Living and Rehab Center (Petitioner or facility) is a nursing facility located in
Raleigh, North Carolina, that is certified to participate in the Medicare program as a
provider of services. On multiple occasions, members of Petitioner’s nursing staff
administered to one of its residents (R1) excessive doses of morphine sulphate. Staff
subsequently misrepresented the incidents, and the facility inadequately investigated.
Based on these findings, the Centers for Medicare & Medicaid Services (CMS) charges
that, from September 24 through December 15, 2005, the facility was not in substantial
compliance with program participation requirements; specifically, its services did not
meet professional standards of quality (42 C.F.R. § 483.20(k)(3)(i)) and R1 was not free
from unnecessary drugs (42 C.F.R. § 483.25(1)(1)). CMS also claims that, from
September 24 through November 20, 2005, the facility’s deficiencies posed immediate
jeopardy to resident health and safety. CMS has imposed a civil money penalty (CMP) of
$178,150 ($3,050/day for 58 days of immediate jeopardy plus $50/day for 25 days of
substantial noncompliance).
2

For the reasons set forth below, I sustain CMS’s determinations.
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
(Secretary) to promulgate regulations implementing the statutory provisions. Act, section
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 C.F.R. § 488.301. Immediate jeopardy exists if the facility’s noncompliance has
caused or is likely to cause “serious injury, harm, impairment, or death to a resident.” 42
C.F.R. § 488.301.

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

Here, responding to a complaint, the North Carolina Department of Health and Human
Services (State Agency) surveyed the facility on November 14 - 15 and November 21,
2005. CMS Exhibit (Ex.) 2; CMS Ex. 36, at 2 (Benson Decl. { 4). The surveyors
concluded that the facility was not in substantial compliance with two Medicare
requirements: 42 C.F.R. § 483.20(k)(3)(i) (services must meet professional standards of
quality) and 42 C.F.R. § 483.25(1)(1) (residents must be free from unnecessary drugs).
They also concluded that, from September 24, 2005, through November 21, 2005, the
facility’s deficiencies posed immediate jeopardy to resident health and safety. CMS Exs.
1, 2.

Thereafter, following a January 9, 2006 survey, the State Agency determined that the
facility achieved substantial compliance as of December 16, 2005, the date it identified in
its plan of corrections as the date it would achieve substantial compliance. P. Ex. 3.
3

CMS has concurred with the State Agency, and imposes a CMP of $3,050 per day for 58
days of immediate jeopardy (September 24 through November 20, 2005) ($176,900), and
$50 per day for 25 days of substantial noncompliance that was not immediate jeopardy
($1,250). The total CMP is $178,150. CMS Ex. 28; P. Exs. 2, 3.

Petitioner timely requested a hearing. The hearing convened on October 25, 2006, in
Raleigh, North Carolina. Mr. Joseph Bianculli appeared on behalf of Petitioner, and Ms.
Leslie A. Connery appeared on behalf of CMS. In the absence of objection, I admitted
into evidence CMS Exhibits 1- 36 and Petitioner Exhibits (P. Exs.) 1- 44. Hearing
Transcript (Tr.) 1.

II. Issues
The issues before me are:

1. Whether, from September 24 through December 15, 2005, the facility was
in substantial compliance with program participation requirements,
specifically, 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25(I)(1);

and

2. If the facility was not in substantial compliance from September 24 through
November 20, 2005, did its deficiencies then pose immediate jeopardy to
resident health and safety?

With respect to the amount of the penalty imposed, if I find immediate jeopardy from
September 24 through November 20, 2005, I must sustain the $3,050 per day CMP,
because that is the statutory and regulatory minimum for deficiencies that pose immediate
jeopardy. 42 C.F.R. § 488.438. Similarly, ifI find that the facility was not in substantial
compliance from November 21, 2005, through December 15, 2005, I must sustain the $50
per day CMP because that is the statutory and regulatory minimum. 42 C.F.R.

§ 488.438(a)(1)(ii).
III. Discussion

A, From September 24 through December 15, 2005, Petitioner was not in
substantial compliance with 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25()(1)
because: 1) its nursing staff repeatedly administered excessive doses of
morphine to a vulnerable resident; 2) its staff repeatedly misrepresented their
actions; and 3) the facility inadequately investigated the incidents.’

Services provided or arranged by the facility must meet professional standards of quality.
42 CFR. § 483.20(k)(3)(i).

Under the statute and the “quality of care” regulation, each resident must receive, and the
facility must provide, the necessary care and services to allow a resident to attain or
maintain the highest practicable physical, mental, and psychosocial well-being, in
accordance with the resident’s comprehensive assessment and plan of care. Act, section
1819(b)(2); 42 C.F.R. § 483.25. Among other quality of care requirements, each
resident’s drug regimen must be free from unnecessary drugs. Unnecessary drugs include
any drug used: i) “in excessive dose (including duplicate drug therapy)”; ii) for excessive
duration; iii) without adequate monitoring; iv) without adequate indications for its use; v)
in the presence of adverse consequences indicating the dose should be reduced or
discontinued; or vi) any combination of the reasons above. 42 C.F.R. § 483.25(1)(1).

Nearing the end of her life, R1 was an 82-year old hospice patient admitted to the facility
on September 21, 2005. She was recovering from sepsis, and had diagnoses of metastatic
colon cancer, Alzheimer’s disease, and diabetes. CMS Ex. 6, at 32, 61; CMS Ex. 36, at 3
(Benson Decl. 6). Among other medications, her physician prescribed morphine
sulphate, 2 milligrams by mouth every two hours. P. Ex. 24, at 1; CMS Ex. 36, at 3
(Benson Decl. { 6). Morphine sulphate is a potentially dangerous and closely-regulated
narcotic, used primarily for pain control and/or to induce sedation. It can be lethal,
especially if used improperly in an excessive dose. CMS Ex. 35, at 3-4, 6 (Guay Decl. 4
6, 9); CMS Ex. 36, at 3, 4 (Benson Decl. 7, 9).

1 [ make findings of fact and conclusions of law to support my decision in this
case. I set forth each finding below, in italics and bold, as a separate heading.
5

The hospice supplied R1’s morphine. It came in a highly concentrated form: 20
milligrams per milliliter. At this concentration, the physician order of 2 milligrams was
equivalent to 0.1 milliliter (or one cubic centimeter) of morphine sulphate, which, the
parties agree, is a very small amount. CMS Ex. 24, at 1; CMS Ex. 36, at 4, 7 (Benson
Decl. {{ 8, 14). The morphine came in a 30-milliliter bottle that had a clear strip down
the side, marked at intervals, so, after administering a dose, staff could determine the
amount of liquid remaining in the bottle. CMS Ex. 24, at 1; CMS Ex. 36, at 7 (Benson
Decl. { 14). With the bottle was a small syringe capable of holding just one milliliter of
liquid, and divided into very small increments of measurement. P. Ex. 42, at 2 (Morlan
Decl.); CMS Ex. 36, at 7 (Benson Decl. { 14).

Federal and state law require that facilities closely monitor their narcotics. Facilities that
dispense morphine are required to keep it under double lock and key, and to maintain
accurate, contemporaneous records of the amount of medication received, administered,
and remaining. CMS Ex. 35, at 6 (Guay Decl. ¢ 9). Accordingly, facilities maintain a
log, called the individual narcotic record (INR), which is separate from the individual
patient’s medication administration record (MAR). The INR lists the patient’s name, the
strength and ordered dosage of his/her medication, the amount of medication initially
provided, and the amount remaining after each administration. CMS Ex. 35, at 8 n.6
(Guay Decl.); CMS Ex. 36, at 4 (Benson Decl. { 9). The administering nurse consults the
INR for the patient’s name, medication, route of administration and dosage. The nurse
notes the amount of medication before the dose is given. After administering the ordered
dose, the nurse measures and records the amount remaining. P. Ex. 35; Tr. 32.

Standards of nursing practice also require that licensed nurses perform a narcotic count at
each shift change, when the narcotic keys change hands. The facility policy reflected this
standard, requiring that the nurse coming on duty and the nurse going off duty make the
count together, and document and report to the Director of Nursing (DON) any
discrepancies. CMS Ex. 36, at 4 (Benson Decl. § 9); CMS Ex. 19; Tr. 105. The DON
was then responsible for investigating the discrepancy to determine its cause, and
providing the facility administrator with a written report of her findings. CMS Ex. 19, at
2.

R1’s Individual Narcotic Record. According to R1’s INR, on ten separate occasions,
nurses gave her ten times more morphine sulfate than ordered by her physician. P. Ex.
35; CMS Ex. 36, at 7-8 (Benson Decl. ¥ 15). The document shows:
6

. At 6:30 p.m. on September 24, 2005 (a Saturday), Registered Nurse (RN) Barbara
Godwin administered a 7.0 milliliter dose instead of a 0.1 milliliter dose, as
ordered by R1’s physician. RN Godwin recorded that 25 milliliters remained in
the bottle after she had administered the dose (down from 26 milliliters in the
bottle before she administered the 6:30 p.m. dose).

. At 10:00 p.m., RN Godwin administered a second 1.0 milliliter dose and recorded
that 24 milliliters remained in the bottle.

. On September 25, a second nurse (Nurse 2) administered three consecutive 1.0
milliliter doses, and indicated that 23, 22, and 21 milliliters, respectively,
remained.

P. Ex. 35, at 1; CMS Ex. 6, at 27.

7 During the late afternoon and evening of September 25, a third nurse administered
three consecutive 1.0 milliliter doses. This nurse recorded that 20, 19, and then 18
milliliters remained in the bottle.

. The following morning, September 26, Nurse 2 again administered two 1.0
milliliter doses and recorded that 17 and then 16 milliliters remained.

. At 8:30 p.m. that evening, a different nurse, LeeAnn Harrelson, administered the
correct dosage, 0.1 milliliter. She recorded that 15.9 milliliters remained.

P. Ex. 35, at 2; CMS Ex. 6, at 28. In all, the INR shows that three nurses administered a
total of ten consecutive drug overdoses to R1.

By itself, the INR evidence should be sufficient to establish that the nurses’ actions did
not meet professional standards of quality and that R1’s drug regime was not free from
unnecessary drugs. Ten times the ordered amount must be considered an “excessive
dose,” and administering the excessive dose on multiple occasions must be considered
“for excessive duration.” Thus, on its face, the documentary evidence shows that the
facility was not in substantial compliance with 42 C.F.R. § 483.25(I)(1) .

If, as the record shows, nursing staff were administering ten times the ordered dosage,
they were obviously not following the physician’s order, and failure to follow a
physician’s order in administering medication violates professional nursing standards.
CMS Ex. 36, at 8 (Benson Decl. § 16). Professional standards also require that nurses
follow specific procedures to insure that residents receive the correct dosage of the
7

correct medication. In addition to the requirements for the administration of narcotics,
discussed above, nursing standards require that, prior to administering any medication, a
nurse must verify that the dosage he/she intends to administer is consistent with the
dosage on the medication’s packaging, the dosage on the MAR and the dosage on the
physician’s order. If any doubt remains as to the appropriate dosage, the nurse should not
administer it, but should consult others, including supervisory nursing staff and/or the
treating physician, to resolve those questions. CMS Ex. 36, at 6 (Benson Decl. { 12).
The glaring errors documented in the INR suggest that these procedures were not
followed. Indeed, as discussed below, Petitioner admits that its nursing staff did not
follow them. The facility was therefore not in substantial compliance with 42 C.F.R.

§ 483.20(k)(3)(i).

Petitioner nevertheless asks that I disregard the INR, claiming that, with one exception,
the INR record entries are in error.” I decline to do so. First, as CMS correctly points out,
federal regulations require that medical records be “complete” and “accurately
documented,” so “it does not help [the facility]’s case to impugn its own medical
recordkeeping practice.” Britthaven of Goldsboro, DAB No. 1960, at 10 n.8 (2005).
Moreover, corroborating evidence confirms that the INR accurately reflects that three
nurses administered the excessive doses of morphine, and that they failed to follow
standard nursing practices designed to prevent the mis-administration of narcotics.

The Facility’s Investigations. At the time of these incidents, Registered Nurse Crystal
Coleman was the Unit Manager on R1’s unit. On September 26, 2005 (Monday), RN
Coleman told the facility’s DON, Lia Morlan, that the count of R1’s narcotic medication
appeared to be “off.” P. Ex. 42, at 2 (Morlan Decl.). Apparently unaware of the
September 24 — 26 entries in R1’s INR, DON Morlan claims that “a nurse apparently had
administered a dose of ‘1.0’ rather than ‘0.1’ ml; but the Resident suffered no adverse
effects.”? P. Ex. 42, at 2 (Morlan Decl.) According to DON Morlan, no one suggested to
her that more than one nurse was involved in over-medicating the resident. DON Morlan
determined (by a means she does not explain) that R1 had not been harmed, and

* If agreed that nursing staff were recording wildly inaccurate medication entries,
I would find that such practice violated professional standards of quality.

3 As discussed infra, contrary to DON Morlan’s assertion of no harm, staff
contemporaneously reported to R1’s physician that R1 suffered decreased respirations
and became extremely lethargic as a result of the medication errors. P. Ex. 34.
8

instructed RN Coleman “to conduct a further investigation, to reconcile the Resident’s
narcotic record, and to complete the medication error report initiated by [Nurse] M.
McAllister.” P. Ex. 42, at 2-3 (Morlan Decl.) DON Morlan also claims that, when she
subsequently followed up, all was in order:

A day or two later, I asked Nurse Coleman whether she had completed her
investigation, and she said that she had, and that everything was OK. Nurse
Godwin apparently had been unaware of her error, and was not scheduled
back in the building (being PRN staff) until Oct. Sth, so plans were made to
bring it to her attention at that time and inservice/counsel her regarding it.
So far as I was concerned, that was the typical, and appropriate, way to deal
with a medication error that caused no harm, and was the end of the matter.

P. Ex. 42, at 3 (Morlan Decl.). DON Morlan now says that, in fact, RN Coleman did not
reconcile the medication count, as she had claimed. P. Ex. 42, at 4 (Morlan Decl.) RN
Coleman supposedly completed a medication error report, but that document has been
destroyed. CMS Ex. 36, at 10 n.4 (Benson Decl.); Tr. 82, 83; but see 42 C.F.R.

§ 483.75(1) (Clinical records must be retained, and the facility must safeguard their
contents against loss or destruction); Tr. 105 (destroying a medication error report is not
in accordance with the standard of care).

About a week after the over-dosing, on October 4, 2005, R1’s son filed a written
complaint, alleging that staff failed to give his mother sufficient pain medication.
Specifically, he alleged that a nurse had signed out his mother’s pain medication, but
went to lunch “and may not have administered it.” P. Ex. 42, at 3 (Morlan Decl.). Under
standards of practice, nurses should not pre-sign for narcotics or any other medications.
Tr. 106. DON Morlan claims that she had already addressed the problem when the
complaint was filed; she instructed the weekend supervisor to counsel the errant nurse not
to sign out meds unless ready to administer them.* Nevertheless, according to DON
Morlan, because R1’s son had sent a copy of his complaint to the state, the facility’s
administrator, Linda Parnell, “was eager to ensure that all of our narcotic records were in
order, if, in fact, a complaint team came in to investigate his allegation.” P. Ex. 42, at 3

* This medication irregularity, like R1’s overdosing, occurred on the weekend,
which suggests that the facility might have been well-advised to examine more carefully
the practices of its weekend staff. But it seems that the facility did not make that
connection, possibly because it was not aware that the earlier R1 medication errors
spanned an entire weekend.
9

(Morlan Decl.); see also P. Ex. 43, at 2 (Parnell Decl.).° To that end, Administrator
Parnell directed a team of registered nurses to audit R1’s narcotic record, as well as the
narcotic records of other residents. P. Ex. 42, at 3-4.

The nurses completed their purported audit on October 4, 2005, and RN Coleman
reported to DON Morlan that R1’s morphine sulfate count was not accurate: the
reconciliation was off by 0.9 milliliter. According to DON Morlan, who had never,
apparently, looked at the INR, “[t]his made sense to me at the time, believing that only
one med error had actually been made.” P. Ex. 42, at 4. DON Morlan goes on to assert
that, by October 6,

the audits had been conducted by 5 registered nurses, the nurses making the
med error and documentation errors had been counseled by the
administrative nurse on call (Becky Hewitt, RN, MDS Coordinator), and the
inservices had been scheduled. The entire investigation had been
completed under the direction of the administrator with the
assistance/advice of the corporate nurse consultant. I felt sure that all was
in order, and [turned my attention] to many pressing issues that took
precedence over a med error that had caused no injury and had been
investigated thoroughly.

P. Ex. 42, at 4-5 (Morlan Decl.) (emphasis added).

But the medication errors had not been “investigated thoroughly” or even adequately.
The nurses’ conclusions were plainly wrong, as shown by review of the INR and some
simple arithmetic. After the 123" dose had been administered, the nurse auditors
measured the remaining morphine sulfate and discovered a discrepancy.® According to
the INR entry for the dose administered at 6:30 a.m. on October 4, 2005 (which was the

° Administrator Parnell has a slightly different recollection. She says that DON
Morlan expressed the concern that the state probably would investigate, and DON Morlan
wanted to be sure that all narcotic administration records were complete and accurate. P.
Ex. 43, at 2 (Parnell Decl.)

® The individual doses are not all numbered consecutively on the INR. The 40
doses listed on the first page of the INR (P. Ex. 35, at 1) are not numbered at all. The
next page contains 60 doses (the 41" through 100 doses administered to R1), numbered
60 down to 1. P. Ex. 35, at 2. The next 36 doses administered to R1 are on the third page
of the INR, and are numbered 120 down to 83. (At space 96, no dose was given; in that
space, staff wrote that they found a 0.9 milliliter discrepancy). P. Ex. 35, at 3.
10

123" dose administered from the bottle) 8.3 milliliters remained. But, at 7:20 a.m. staff
measured only 7.4 milliliters remaining in the bottle. They concluded that the dosage was
off by 0.9 milliliter.’ P. Ex. 35, at 3.

In fact, the discrepancy was far more significant than 0.9 milliliter. Staff began to
administer the medication on September 21, 2005, starting with 30 milliliters.* Had they
consistently administered the medication properly, by the 123! dose, staff would have
administered about 12.3 milliliters of morphine. (123 x 0.1 = 12.3). 17.7 milliliters
should have been left in the bottle. (30 - 12.3 = 17.7). The discrepancy was 9.4
milliliters, not 0.9, as the DON has claimed. (17.7 — 8.3 = 9.4). That’s almost a third of
the bottle. This count is absolutely consistent with the finding that ten excessive doses
had been given. Accord CMS Ex. 35, at 15 (Guay Decl. { 20); Tr. 146; CMS Ex. 36, at
11 (Benson Decl. 22).

The facility’s medication error report indicates that staff advised R1’s physician (and the
facility medical director), Ray Thigpen, M.D., that from September 24, 2005 through
September 26, 2005, three different nurses administered nine excessive doses (“1 cc
instead of 0.1 cc”) of morphine sulfate to R1. P. Ex. 34; CMS Ex. 8. The facility
administrator signed the report on October 6. The pharmacist signed it on November 20,

’ Ina written statement she provided to the surveyors at the time of the survey,
DON Morlan claimed that the nurse auditors inaccurately subtracted and the discrepancy
was 0.7 rather than 0.9. She does not explain how she came up with that figure. CMS
Ex. 13, at 1.

® Petitioner posits, without any supporting documentation, that the vial may not
have contained 30 milliliters of morphine. Citing rules for drug labeling (21 C.F.R.
§ 201.51(g)) for the proposition that liquid drugs must state on their labels the minimum
volume contained therein and may otherwise vary as much as 10%, Petitioner suggests
that the vial may have contained as few as 27 milliliters. P. Posthearing Br. at 13 et seq.
But this does not follow. Assuming the hospice complied with federal labeling
regulations — and no evidence suggests that it did not — the vial contained at least 30
milliliters, and as many as 33 milliliters, of morphine sulphate. That up to three
additional milliliters might be unaccounted for hardly furthers Petitioner’s case. In any
event, since all of the records that mention an initial amount of morphine sulfate say that
the facility received 30 milliliters, and no record suggests any other amount, I can
reasonably conclude that the facility received 30 milliliters of morphine sulfate. See P.
Exs. 5, 35; CMS Ex. 6, at 26, 27. Ultimately, the facility nurses are responsible for
verifying the amount of medication received (Tr. 104), and they consistently recorded
receipt of 30 milliliters. P. Exs. 5,35; CMS Ex. 6, at 26.
11

2005. P. Ex. 34. Although she was the individual charged with overseeing the
investigation, DON Morlan did not sign the report at all, which suggests that she did not
review it and is consistent with her apparent ignorance as to its contents.

In a separate note dated September 26, 2005, at 11:25 p.m., Matresse McAllister, the
nurse who “initiated” the medication error report (P. Ex. 42, at 3 (Morlan Decl.)), wrote:

[indecipherable] Dr. Thigpen in regards to medication error
found on [R1]. Morphine Sulfate 2 mg po q 2° for pain
(terminal cancer) was given at | cc instead of 0.1 cc as
ordered starting on 9/24/05 ending on 9/26/05 at 4:30 am X 9
[indecipherable].

Weekend supervisor aware. Med error report filled out left
[with] DON.

CMS Ex. 8, at 2.°

Notwithstanding this compelling documentary evidence — generated contemporaneously
by its own staff — Petitioner concedes only that one nurse administered one overdose. On
November 14, 2005, both the facility’s DON and its MDS coordinator (Becky Hewitt)
told Surveyor Benson that, notwithstanding the documentation of ten errors, only one
dosage error occurred (“I know it looks like nine errors to you, but it was really only
one.”). CMS Ex. 36, at 12 (Benson Decl. § 23). In support, Petitioner points out that
only RN Godwin admitted making a medication error.'° The other two nurses insisted

° The contemporaneous documents thus show that staff reported to Dr. Thigpen
multiple instances of overdosing throughout the weekend of September 24 — 26. I
therefore find unconvincing Dr. Thigpen’s declaration that:

As I understood it, a nurse reconciling the patient’s narcotic
count on Monday morning September 26 discovered a
discrepancy, and determined that a weekend nurse apparently
had administered 1.0 rather than 0.1 milliliters of morphine.

P. Ex. 44, at 3 (Thigpen Decl.).

© RN Godwin complained that she had difficulty reading the label on the box of
morphine sulfate because it was “smeared” and she thought that it read “2 mg/ml” —a
much less concentrated formulation (CMS Ex. 35, at 5 (Guay Decl. 4 8)) — rather than “20
12

that they gave the correct dosage, but, in recording the dosage, put the decimal point in
the wrong place, and, according to DON Morlan, “I had no way at that time to determine
whether they were telling the truth or not.” P. Ex. 42, at 5; CMS Ex. 13, at 2.

Had the DON followed up on her staff’s denials, she would have realized how
inconsistent their claims were with all of the other evidence. As the above discussion
shows, the amount of morphine remaining on October 4 is consistent with the finding of
ten overdoses. DON Morlan overlooks the October 4 count, and argues that, by the time
she learned the extent of the problem — which was not until the time of the survey — it
was “impossible” to determine how much medication was administered in excess of the
ordered amount since, “we were unable physically to measure the amount of medication
remaining in the vial, because the vial was used up on October 5, and discarded at that
time.” P. Ex. 42, at 5 (Morlan Decl.). But this assertion is also wrong. It would have
been very easy to “measure” and reconcile at any time, with or without the vial. Facility
staff knew how much medication they started with; they knew the number of doses given;
and they knew the amount of medication left in the vial as of October 5 — none. On that
day it was “used up.”"!

Another obvious problem with the nurses’ claims that their sole errors were in misplacing
a decimal point: how to account for their entries under the amount remaining, which they
invariably recorded as 1.0 milliliter less than the amount they started with. P. Ex. 35, at 1,
2; CMS Ex. 6, at 26, 27. Petitioner now concedes that staff made no effort to measure
independently the amount of medication remaining in the vial, and that they simply

mg/ml.” CMS Ex. 10; CMS Ex. 36, at 8 (Benson Decl. { 17). Of course, inability to read
the label does not justify administering the wrong dosage, and I agree with CMS’s expert
pharmacologist, Dr. David Guay, that for a nurse to administer a medication without
verifying the correct dosage deviates from the most basic standards for medication
administration. CMS Ex. 35, at 10 (Guay Decl. ¢ 14).

11 DON Morlan asserts in her declaration that the morphine was “used up” on
October 5, which I accept. I note, however, that the final entries on the INR show that at
6:30 a.m. a nurse administered 0.5 milliliter (in accordance with an October 4 physician’s
order), leaving 2.2 milliliters of morphine sulfate. At 8:30 p.m., another nurse
administered 0.5 milliliters, although the “amount left” entry has been crossed out. The
INR contains no other entries. Presumably, 1.7 milliliters, or approximately 3 more doses
would have remained, which, following the physician’s order, would have depleted the
morphine that day. P. Ex. 35, at 3. On October 7, two days after the vial of morphine
was “used up,” R1’s physician discontinued the morphine and ordered the Fentanyl. P.
Ex. 23, at 4.
13

subtracted the “incorrectly recorded” (1.0 milliliter) dosage from the amount previously
recorded. P. Pre-hearing Br. at 13-14. This certainly explains how the narcotic
medication count could be off by 9.4 milliliters without the staff’s noticing. But it is no
defense. The practice is wholly inconsistent with standards of quality for dispensing and
tracking narcotics, and therefore violative of 42 C.F.R. § 483.20(k)(3)(i).

Further, if these nurses were telling the truth, which I find highly unlikely, then the
facility still had a significant and uninvestigated problem — almost a third of R1’s
morphine disappeared. Where did it go?

I reject Petitioner’s poorly supported suggestion that the “viscosity” of the drug rendered
it impossible to measure (thus justifying staff’s failure to measure the amount remaining
after they administered a dose), and explains the 9.4 milliliter discrepancy. I note that no
one who was actually charged with administering the medication testified. I see no
complaints from staff that they could not measure the amounts remaining in the vial. The
only support for Petitioner’s argument is DON Morlan’s description of the medication as
“a thick syrup, similar to common children’s medicines.” P. Ex. 42, at 2 (Morlan Decl.).
On the other hand, Dr. Guay, who would know, testified that the morphine sulphate is not
a thick, viscous liquid. “[I]t’s a thin, aqueous — that is, water-based liquid — this is not
difficult to draw up. It doesn’t cling exceedingly to glass or to syringes.” Tr. 149.

I recognize that the ordered dosage was small, and staff might have difficulty
distinguishing 0.1 milliliter increments. However, this difficulty does not entitle staff to
ignore the requirement that they independently verify and record the amount remaining.
As Dr. Guay points out, had any nurse done so from September 24 through 26, 2005,
(s)he would have noticed a very perceptible change in the level of liquid in the bottle,
which should have alerted him/her to the excessive dosing. CMS Ex. 35, at 11 (Guay
Decl. § 16). Further, even if the individual nurses failed to verify the amount remaining
after they administered the medication, staff responsible for counting narcotics at each
shift change should have done so, leading to earlier detection of the overdosing.

Dr. Guay acknowledged, and I accept, that some waste is inevitable, but it would be
small. Tr. 151-152. See, e.g., P. Ex. 35, at 1. For example, at 10:30 p.m. on September
23, a nurse administered 0.1 milliliter, but recorded that the amount decreased from 27.3
to 27.1. This was likely a reasonable adjustment based on the loss of 0.1 milliliter after
27 doses had been administered. That reasonable degree of “waste” is a far cry from
almost ten milliliters. It strains credulity to conclude that one-third of this powerful
narcotic was lost because it clung to the syringe or to the sides of the vial.
14

Thus, compelling evidence establishes that three nurses administered to R1 ten
consecutive morphine overdoses. Because staff were not adequately monitoring the
remaining amount of the narcotic, the errors went undetected. When confronted, the
nurses denied responsibility, and the facility did not follow up. Ironically, DON Morlan
asserts that ““owning up to our mistakes is one of the most important facets of nursing.”
CMS Ex. 13, at 2. I agree that owning up to mistakes is critically important, but conclude
that the facility’s nursing staff did not do so.

In other respects, the facility’s investigation fell short of standards of quality. Facility
policies made DON Morlan responsible for investigating and reporting medication errors.
When the error was initially brought to her attention on September 26, 2005, she
delegated that task to the Unit Manager, “which is my usual practice.” P. Ex. 42, at 7
(Morlan Decl.). It seems that RN Coleman conducted no real investigation. She may
have asked the responsible nurses whether they had given the correct dosages, but she
made no effort to reconcile the amount of medication left in the bottle with the amount
listed on the INR at that time. DON Morlan concedes the inadequacy of the investigation,
but characterizes it as “inconsequential”:

As it happens, the nurse reported to me that she had
conducted a complete investigation when she really had not,
but I had no reason to doubt her report to me at the time.
While it obviously would have been better for the nurse to
have completed her investigation, even in retrospect, her
failure to do so seems inconsequential, since my nursing staff
did promptly identify and address the cause of the error, and
we promptly took appropriate corrective action.

P. Ex. 42, at 7 (Morlan Decl.).

The facility’s failure to investigate was hardly “inconsequential.” Given the serious risks
posed by a narcotic overdose, and the number of nurses involved, standards of practice
dictate an immediate narcotic medication count. CMS Ex. 36, at 11 (Benson Decl. §§ 21,
22); Tr. 98. (“[W]ith a narcotic like morphine and overdosing at that level, there should
have been an immediate response.”) That she delegated this responsibility does not
absolve the DON, or the facility, from its obligation to ensure that the action was taken.
See Emerald Oaks, DAB No. 1800, at 7 n.3 (2001) (The facility “cannot disown the
consequences” of inadequate care by the simple expedient of pointing the finger at staff,
who are agents of the facility, “empowered to make and carry out daily care decisions.”)
15

Additional findings. Although the most serious, R1’s overdosing was not the only
problem the surveyors found with respect to narcotics administration. The incident that
led to R1’s son complaining about staff’s failure to administer medication to his mother
was not isolated. On October 1, 2005, facility auditors found that a nurse had “pre-signed
for all narcotics for the shift.” CMS Ex. 26, at 3.

The surveyors found another overdosing incident of which the facility seemed unaware.
R4’s physician ordered Lorazepam (Ativan), a controlled substance, one tablet, twice a
day, at 8:00 a.m. and 8:00 p.m. CMS Ex. 14, at 5. R4’s INR shows that on October 28,
2005, staff administered to her at least three tablets, at 7:30 a.m., 2:00 p.m., and 8:00 p.m.
Id. at 6."

While Petitioner concedes that its staff made mistakes, it argues that the facility should
not be held accountable for those errors. Petitioner points out that “every nurse is trained
and drilled to record medications properly, and it is not clear how Petitioner, or any
nursing facility, could prevent this sort of error.” P. Posthearing Br. at 38. In Petitioner’s
view, the problem was “the result of human error” rather than some systemic breakdown.
P. Br. at 2. As pointed out in Barn Hill Care Center, DAB No. 1848, at 18 (2002), the
regulatory requirements offer no “human error” exception:

Indeed, it is difficult to imagine any deficiency that is not, at
its core, attributable to “human error.” A facility, therefore,
puts in place systems that minimize the chance for “human
error.”

Id. at 18, citing DAB CR902, at 10 (2002).

Here, those systems failed. The individual nurses administering the medication did not
follow appropriate protocols, and administered narcotics overdoses. Narcotic counts at
shift change should have picked up the errors, but did not. When someone finally
noticed, the person charged with investigating conducted no real investigation, but
represented that she had. Staff’s purported eventual reconciliation of the narcotics was
inadequate; they did not consider how much medication should have been administered

12 Tn fact, the INR contains four entries dated October 28. The first (found on line
2) says that a tablet was given at 8:00 p.m. Staff probably made a mistake in entering the
date, since the next entry shows that a tablet was administered at 7:30 a.m. on October 27.
CMS Ex. 14, at 6.
16

and how much should have remained. These shortcomings mean that the facility was not
in substantial compliance with program requirements, specifically 42 C.F.R.
§§ 483.20(k)(3)(i) and 483.25(1)(1).

B. CMS’s determination that the facility’s deficiencies posed immediate
jeopardy to resident health and safety is not clearly erroneous.

I next consider whether CMS’s immediate jeopardy finding was “clearly erroneous.”

CMS’s determination as to the level of a facility’s noncompliance — which includes its
immediate jeopardy finding - must be upheld unless it is “clearly erroneous.” 42 C.F.R. §
498.60(c). The Departmental Appeals Board has observed repeatedly that the “clearly
erroneous” standard imposes on facilities a “heavy burden” to show no immediate
jeopardy, and has sustained determinations of immediate jeopardy where CMS presented
evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”
Barbourville Nursing Home, DAB No. 1962, at 11 (2005); Florence Park Care Center,
DAB No. 1931, at 27-28, citing Koester Pavilion, DAB No. 1750 (2000).

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

The parties have debated at some length whether the morphine overdoses caused R1
actual harm. CMS points to evidence of her reduced respiratory rate, periods of sleep
apnea, and episodes of Cheyne-Stokes breathing, to establish serious harm attributable to
the overdosing. CMS Ex. 35, at 6-7, 12 (Guay Decl. {9 10, 11, 17); CMS Ex. 36, at 5, 13
(Benson Decl. ff 10, 24); P. Ex. 26, at 4; Tr. 66, 75. Petitioner argues that these
problems were instead attributable to R1’s underlying conditions, and that the overdosing
caused her no harm. P. Ex. 42, at 2, 3, 6, 7 (Morlan Decl.); P. Ex. 44, at 3 (Thigpen
Decl.). I note that Petitioner’s position is inconsistent with the surviving medication error
report. That document indicates that, as a result of the excessive dosing, R1 suffered
decreased respirations and became “extremely lethargic.” According to the report, her
morphine was subsequently withheld (likely subjecting her to increased discomfort) until
these problems resolved. P. Ex. 34.

In any event, the regulation does not require that a resident suffer actual harm; the
likelihood of serious injury or harm creates immediate jeopardy. Morphine is widely
known to have life-threatening side effects if administered in excessive amounts. CMS
Ex. 36, at 13 (Benson Decl. § 24). Even Dr. Thigpen agrees that an overdose of a
narcotic medication potentially can be a serious matter. P. Ex. 44, at 3 (Thigpen Decl.)
Here, on multiple occasions, facility nurses administered to a vulnerable resident
17

massively excessive doses of that narcotic. Their errors “related to some of the most
basic concepts of nursing practice.” CMS Ex. 36, at 13 (Benson Decl. 4 24). The facility
then failed to investigate adequately. Indeed, facility administration was not even aware
of the seriousness of the overdosage until the time of the survey.

In light of these significant facts, I do not find “clearly erroneous” CMS’s immediate
jeopardy determination.

C. The duration of the penalty is consistent with statutory and regulatory
requirements.

The Board has repeatedly explained that, under the regulatory scheme, any deficiency that
has a potential for more than minimal harm is necessarily indicative of problems in the
facility that need to be corrected. Barn Hill Care Center at 12-18; Lake City Extended
Care Center, DAB No. 1658, at 14 (1998). Since I found that the deficiencies cited have
the potential for more than minimal harm, I must also find that the facility was out of
compliance “from the date of the completion of the survey in which [these deficiencies]
were cited until the date of the resurvey in which substantial compliance was
established.” Lake City at 14-15. Substantial compliance means not only that the specific
cited instances of substandard care were corrected, and that no other instances have
occurred, but also that the facility has implemented a plan of correction designed to assure
that no such incidents occur in the future. No findings that the facility violated the
standard of care between these dates are required in order to find the facility out of
substantial compliance, nor can evidence of other incidents in which the facility met the
standard of care change the fact that it was out of substantial compliance. Barn Hill Care
Center; Lake City at 15; see also Hermina Traeye Memorial Nursing Home, DAB No.
1810, at 19 (2002) (“The burden is on the facility to prove that it has resumed complying
with program requirements, not on CMS to prove that deficiencies continued to exist after
they were discovered.”); Asbury Center at Johnson City, DAB No. 1815, at 20 (2002)
(‘[A] facility’s return to substantial compliance must usually be established through a
resurvey, and in a situation involving inadequate supervision, requiring such a resurvey
appears wise.”); Cross Creek Care Center, DAB No. 1665 (1998).

Petitioner has not established that an effective plan of correction had been implemented
any earlier than CMS has found. In fact, additional violations of the standards of care
occurred. The surveyors found that on October 28, 2005, R4 had received an additional
dose of Lorazepam, an error that was never noted or investigated. CMS Ex. 14, at 5. In
Dr. Guay’s opinion:
18

[T]he situation involving [R4] reflects many of the same
problems with medication administration that were evident in
the facility’s administration of morphine sulphate to [R1].
The fact that [R4] received a dose of Lorazepam that was not
ordered by her physician strongly suggests that the nurse
providing the medication failed to review the MAR, INR, and
physician order prior to giving the medication. Moreover, it
is my understanding that facility staff were not aware of the
extra dose until the surveyors brought it to their attention. In
my opinion, the nursing staff should have identified this error
at the next scheduled medication time through review of the
MAR, INR, and physician’s order. The fact that the situation
occurred approximately one month after staff administered
excessive doses of morphine sulfate to [R1] suggests that this
facility continued to evidence significant problems with
fundamental aspects of medication administration.

CMS Ex. 35, at 16 (Guay Decl. § 22).

At the time of the survey, no effective investigation of R1’s overdosing had occurred.
Administrative staff were not even aware of the extent of the facility’s problem. In its
plan of correction, the facility promised closer DON oversight in the administration of
liquid narcotics. But on November 16, 2005, the DON learned for the first time of a
November 11 order for a liquid narcotic. She later learned that the bottle created
difficulty for staff in counting the drug, and returned it to the pharmacy, asking that it be
repackaged in a container “that allowed for easier visualization.” CMS Ex. 36, at 14
(Benson Decl. { 25); Tr. 56-57.

On November 21, 2005, the facility’s risk manager finally trained the nurses and the
Administrator on the proper procedures for investigating medication errors. I agree that
such training was “a necessary predicate to the removal of immediate jeopardy because
the facility’s handling of the events involving Resident # 1 demonstrated that
administrative staff did not understand the importance of conducting a thorough
investigation.” CMS Ex. 36, at 15 (Benson Decl. 26). However, training alone does
not ensure that the cited deficiencies will not recur. The facility must then follow-up with
staff to verify that they have understood and implemented the practices taught.
19

D. The facility’s per day CMP for the period of noncompliance at the
immediate jeopardy level must be at least $3,050, and the CMP for each
day of noncompliance that is not immediate jeopardy must be at least $50.

The statute and regulations limit my authority to review the amount of the CMP. In
situations such as this, where the deficiencies constitute immediate jeopardy, CMS may
impose a CMP in the range of $3,050 to $10,000 per day. 42 C.F.R. § 488.438. Where a
CMP of $3,050 per day is imposed, the daily amount must be sustained unless the nursing
home establishes that the determination of immediate jeopardy is clearly erroneous.
Hermina Traeye Memorial Nursing Home, DAB No. 1810, at 16 (2002).

With respect to the days of substantial noncompliance that was not immediate jeopardy,
the minimum penalty must be at least $50 per day. 42 C.F.R. § 488.438.

IV. Conclusion

For all of the reasons discussed above, I uphold CMS’s determination that from
September 24 through December 15, 2005, the facility was not in substantial compliance
with program participation requirements, specifically 42 C.F.R. §§ 483.20(k)(3)(i)
(services must meet professional standards of care) and 483.25(1)(1) (residents must be
free from unnecessary drugs). I uphold CMS’s determination that, from September 24
through November 20, 2005, the facility’s deficiencies posed immediate jeopardy to
resident health and safety.

The CMP imposed is the statutory minimum and is therefore reasonable as a matter of
law.

/s/

Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

)
In the Case of: )
) Date: May 25, 2007

Twin Pines Nursing and )
Rehabilitation Center, )
(CCN: 67-5638) )

) Docket Nos. C-07-13 & C-07-122

Petitioner, ) Decision No. CR1601
)
-v.- )
)
Centers for Medicare & Medicaid )
Services. )
)
DECISION

The requests for hearing are dismissed pursuant to 42 C.F.R. § 498.70(b).
1. Background

Petitioner is a skilled nursing facility located in Victoria, Texas, licensed by the State of
Texas and authorized to participate in the federal Medicare program and the state
Medicaid program. On September 15, 2006, the Texas Department of Aging and
Disability Services (the state agency) completed a survey of Petitioner’s facility. The
state agency alleged, based on the survey, that Petitioner was in violation of 42 C.F.R.

§ 483.25(h)(2). The Centers for Medicare & Medicaid Services (CMS) subsequently
notified Petitioner that it was imposing a per instance civil money penalty (PICMP) of
$1500 for the alleged violation 42 C.F.R. § 483.25(h)(2) and the remedies of termination
and denial of payment for new admissions (DPNA). Joint Stipulation of Fact filed
February 16, 2007 (Jt. Stip.).
2

Petitioner requested a hearing by letter dated October 10, 2006. The case was docketed as
C-07-13 and assigned to me for hearing and decision. Petitioner filed a second request
for hearing on November 27, 2006, which was docketed as C-07-122 and assigned to me
for hearing and decision. By Order dated December 18, 2006, the two cases were
consolidated for hearing and decision. The case is presently set for hearing on May 31,
2007.

CMS advised Petitioner by letter dated December 27, 2006, that it rescinded the
termination and DPNA remedies but that the PICMP remained in effect. CMS Prehearing
Brief at 2.

On May 15, 2007, CMS filed a motion to dismiss Petitioner’s request for hearing with a
supporting memorandum (CMS Brief) and exhibits (CMS Exs.) 1 through 3. On May 17,
2007, Petitioner filed its response in opposition to the CMS motion to dismiss (P. Brief).

II. Discussion

CMS notified Petitioner by letter dated December 27, 2006, that it rescinded the remedies
of termination and DPNA it previously proposed. CMS Ex. 2. CMS notified Petitioner
by letter dated May 11, 2007, that it rescinded the $1500 PICMP it previously proposed.
CMS Ex. 3. CMS argues that because Petitioner is no longer subject to enforcement
remedies, it has no right to a hearing. CMS Brief at 2-3. Petitioner acknowledges that all
remedies have been rescinded in this case and that rescission of all enforcement remedies
resulted in dismissal in prior cases. Petitioner nevertheless argues that the request for
hearing should not be dismissed in this case because it is necessary to have an
adjudication of the allegation of deficiency to correct potentially erroneous information
regarding the deficiency finding that has been publicly released. P. Brief at 3-4.

A provider does not have a right to a hearing to challenge every action by CMS with
which it disagrees. Only certain actions create hearing rights. In general, a participating
long-term care facility will have a right to a hearing if CMS makes an initial
determination to impose a remedy against that facility. 42 C.F.R. § 498.3(b)(13). The
possible remedies that CMS might impose against a facility are specified at 42 C.F.R.

§ 488.406(a). No right to a hearing exists pursuant to 42 C.F.R. § 498.3(b)(13), unless
CMS determines to impose — and actually imposes — one of the specified remedies.
Lutheran Home — Caledonia, DAB CR674 (2000), aff'd, DAB No. 1753 (2000);
Schowalter Villa, DAB CR568 (1999), aff'd, DAB No. 1688 (1999); Arcadia Acres, Inc.,
DAB CR424 (1996), aff'd, DAB No. 1607 (1997). Indeed, the Secretary of Health and
Human Services (Secretary) specifically rejected a proposal to grant hearing rights for
deficiency findings that were made without the imposition of remedies. 59 Fed. Reg.
56116, 56158 (Nov. 10, 1994).
3

It is the imposition or proposed imposition of an enforcement remedy and not the citation
of a deficiency, that triggers the right to a hearing under 42 C.F.R. Part 498. See
Eaglecare, Inc., d/b/a Beech Grove Meadows, DAB CR923 (2002); Schowalter Villa,
DAB No. 1688 (1999); Arcadia Acres, Inc., DAB No. 1607 (1997). See also, The
Lutheran Home-Caledonia, DAB No. 1753 (2000), Walker Methodist Health Center,
DAB CR869 (2002), Charlesgate Nursing Center, DAB CR868 (2002), D.C. Association
for Retarded Citizens, DAB CR776 (2001), Alpine Inn Care, Inc., DAB CR728 (2000),
Woodland Care Center, DAB CR659 (2000), and Fort Tryon Nursing Home, DAB
CR425 (1996). In each of these cases, the failure or inability of the petitioner to
demonstrate that the appealed survey findings and deficiency determinations had resulted
in a remedy was fatal to its appeal. In each of these cases, the appeal was dismissed. The
appellate panels of the Departmental Appeals Board and the administrative law judges
who decided these cases have uniformly concluded that a citation of deficiency that is not
the basis for an enforcement remedy or that results in the imposition of a remedy that is
later rescinded or reduced to zero, does not trigger the right to a hearing under Part 498.

Petitioner does not have a right to a hearing in this case. The undisputed facts establish
that while CMS initially determined that Petitioner was deficient and imposed a PICMP
against Petitioner, CMS has now rescinded all enforcement remedies. Petitioner no
longer suffers any injury that I am authorized to redress and Petitioner no longer has a
right to hearing pursuant to 42 C.F.R. Part 498.

II. Conclusion

Based upon the foregoing reasons, Petitioner’s requests for hearing are dismissed
pursuant to 42 C.F.R. § 498.70(b) and the hearing scheduled for May 31, 2007, is
cancelled.

/s/

Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of:
Social Security Administration,
Date: May 22, 2007
Petitioner,
“Vee Docket No. C-07-196

Decision No. CR1600
Karen Kay Parham,

Respondent.

DECISION AND ORDER DISMISSING CASE

This matter is before me on the Office of the Inspector General, Social Security
Administration’s (1.G.’s) Motion to Dismiss the Request for Hearing filed January 11,
2007, by Respondent pro se Karen Kay Parham. The I.G.’s Motion asserts that the
Request for Hearing is untimely filed, and the Motion is based on the terms of 20 C.F.R.
§§ 498.202(c)(2) and 498.202(f)(1). As I explain below, I find that the Request for
Hearing was not timely filed, and for that reason, I grant the I.G.’s Motion to Dismiss.

I. Procedural Background

Karen Kay Parham, Respondent pro se, was a recipient of Supplemental Security Income
disability benefits under Title XVI of the Social Security Act (Act). The I.G. received
information suggesting that she had given false statements in maintaining her eligibility
for those benefits, and on May 10, 2006, wrote to Respondent announcing that the I.G.
was considering the imposition of civil monetary penalties and assessments against her.
The I.G.’s action was based on section 1129 of the Act, 42 U.S.C. § 1320a-8.
2

Respondent engaged counsel in late June 2006, and some discussions of a negotiated
resolution of the matter began. Those discussions were unproductive, however, and on
August 9, 2006, the I.G. sent Respondent notice that a civil monetary penalty of
$10,000.00 and an assessment in lieu of damages of $7356.00 were to be imposed.

Respondent filed her Request for Hearing pro se, in a letter dated January 4, 2007. The
letter was mailed January 11, 2007. I scheduled a telephonic prehearing conference for
February 7, 2007, but before that conference could be convened, the I.G. filed a Motion to
Dismiss on February 1, 2007. The I.G.’s Motion was based on the apparent untimeliness
of Respondent’s Request for Hearing, and contained both argument and authorities in
support of the Motion.

The prehearing conference was held as scheduled, and its results are set out in the Order
of February 8, 2007. The cycle of briefing established in that order has concluded, and
the record in this case closed on April 16, 2007. The evidentiary record before me is
made up of eight exhibits: the I.G. has proffered I.G. Exhibits 1-8 (1.G. Exs. 1-8), and in
the absence of Respondent’s objection, they are admitted. Respondent has proffered no
exhibits of her own.

It will be noted that I have described Respondent as appearing here pro se. Her Request
for Hearing was signed by her in propria persona, but all subsequent pleadings on her
behalf have been signed by a male relative at Respondent’s mailing address, one Peter E.
Parham, who styles himself as “representing Karen Kay Parham.” He has never filed an
entry of appearance, but I have treated his participation as substantially compliant with 20
CFR. § 498.211(a)(3).

IL. Issue

The issue before me is whether Respondent’s Request for Hearing was timely filed, in
compliance with 20 C.F.R. § 498.202(c)(2). If the Request was not filed in a timely
manner, and if Respondent has not demonstrated good cause for filing her Request
untimely, | am required by the mandatory language of 20 C.F.R § 498.202(f)(1) to
dismiss it.

This issue must be resolved against Respondent. Her Request for Hearing was filed
untimely, almost three months later than the deadline established by regulation. She has
failed here to demonstrate good cause for her untimeliness. In the absence of such a
showing, her Request for Hearing must be dismissed.
ILI. Controlling Statutes and Regulations

Section 1129(a) of the Act, 42 U.S.C. § 1320a-8(a), provides in general terms that any
person who makes or causes to be made false, misleading, or incomplete statements of
material fact for use in determining initial or continuing eligibility for benefits under
certain programs created by the Act shall be subject to civil monetary penalties and
assessments in licu of any damages sustained by the programs as a result of those
statements. One of the programs included in section 1129(a)’s protection is Title XVI of
the Act, the disability benefits program called Supplemental Security Income. The
statutory language appears in substantially similar form at 20 C.F.R. §§ 498.102(a) and
498.103(a), and the specific steps by which the I.G. must proceed are set out at 20 C.F.R.
§ 498.109.

Section 1129(b) of the Act, 42 U.S.C. § 1320a-8(b), creates a right to appeal the
imposition of civil monetary penalties and assessments. The procedures governing such
appeals appear at 20 C.F.R. Part 498, and the 60-day deadline for filing a hearing request
is established at 20 C.F.R. §§ 498.109(a)(5)(ii), 498.110, and 498.202(c)(2). 20 C.F.R.

§ 498.202(f) provides:

(f) The ALJ shall dismiss a hearing request where:

(1) The respondent’s hearing request is not filed in a timely manner
and the respondent fails to demonstrate good cause for such failure;

20 C.F.R. § 498.202(H)(1).

Documents filed in appeals governed by 20 C.F.R. Part 498 are considered filed when
they are mailed. 20 C.F.R. § 498.211(a)(4).

IV. Findings and Conclusions

I find and conclude as follows:

1. By letter dated August 9, 2006, the I.G. notified Respondent that she was subject to a
civil monetary penalty and assessment in the sum of $17,356.00. The I.G. relied on the

terms of section 1129 of the Social Security Act (Act), 42 U.S.C. § 1320a-8. LG. Ex. 3,
at 1-4.
4

2. Respondent received the I.G.’s notice letter on August 15, 2006. I.G. Ex. 3, at 5.

3. Respondent, through counsel, was aware that the last date on which Respondent’s
Request for Hearing would have been timely filed was October 16, 2006. I.G. Ex. 6.

4. Respondent filed her untimely Request for Hearing, dated January 4, 2007, by United
States Postal Service, Certified Mail No. 7006 0810 0001 9405 2696, on or about January
11, 2007. Respondent’s Request for Hearing; 20 C.F.R. § 498.211(a)(4).

5. Respondent has not shown good cause for her failure to file her Request for Hearing
timely.

6. Because Respondent’s Request for Hearing was not timely filed and because no good
cause has been shown for her failure to file it timely, her Request for Hearing must be
dismissed. 20 C.F.R. §§ 498.202(c)(2) and 498.202(f)(1).

V. Discussion

In the months before the I.G.’s final actions to impose the civil monetary penalty and
assessment, Respondent was represented by counsel, and that counsel actively sought to
prevent or mitigate the I.G.’s proposed action. On May 10, 2006, the I.G. notified
Respondent that her statements in support of her eligibility to receive Social Security
disability benefits were being investigated, and that she might be liable to sanctions in the
form of civil monetary penalties and assessments. I.G. Ex. 1, at 1-3. She was offered an
opportunity to submit financial statements or other documents in response. /d.
Respondent’s counsel replied by letter of June 5, 2006: the attorney’s letter denied the
factual bases of the I.G.’s allegations, attached an affidavit dated June 6, 2006, supporting
that denial, and included a financial disclosure statement signed by Respondent and dated
June 5, 2006. 1L.G. Ex. 2. Three weeks later, Respondent’s attorney submitted to the I.G.
a Form SSA-1696-UA, the “Appointment of Representative” form by which claimants’
representatives enter their appearances in Social Security Administration administrative
itigation. 1.G. Ex. 4.

Respondent’s efforts to deflect the I.G.’s proposed action were unsuccessful. On August
9, 2006, the I.G. wrote to Respondent announcing the imposition of a civil monetary
penalty and assessment totaling $17,356.00 I.G. Ex. 1, at 1-3. On September 26, 2006,
the I.G. reminded Respondent’s attorney that the deadline for appeal of the I.G.’s action
was October 16, 2006, although it appears that some negotiations were still open. I.G.
Ex. 6.

5

There is no real debate about most of the chronology in this appeal. Respondent does not
contest her receipt of the I.G.’s letter of August 9, 2006, although she does not directly
admit here the date or approximate date of her receipt. Postal records confirm that she
personally received it on August 15, 2006. I.G. Ex. 3, at 5.

The I.G.’s letter of August 9, 2006 could not have been clearer in informing Respondent
about the steps required and the deadlines to be met in appealing the action: the last two
paragraphs on the letter’s third page explain those steps in detail, and include the
warning: “If you do not request a hearing within the 60-day period, the proposed civil
monetary penalty and assessment will be imposed upon you. You will have no right to
an administrative appeal after that time.” I.G. Ex. 3, at 3 (emphasis in original). And
although Respondent has never candidly conceded her awareness of the October 16, 2006
deadline for filing her Request for Hearing, as noted above, it is shown to have been
brought to her attorney’s attention explicitly on September 26, 2006. I.G. Ex. 6.

Nevertheless, the October 16, 2006 deadline for appeal came and went, and when
Respondent mailed her Request for Hearing on January 11, 2007, it was untimely by
nearly three months. Unless she could show good cause for her dilatory filing,
Respondent’s Request for Hearing was subject to mandatory dismissal: the regulation
provides that “[t]he ALJ shall dismiss a hearing request . . .” when good cause is not
shown for late filing. 20 C.F.R. § 498.202(f)(1) (emphasis added).

Respondent’s position here is that the untimely filing is simply not her fault: she
complains of her attorney’s inaction, but cannot explain her own. She asserts, in
increasingly florid language, that her attorney’s conduct “demonstrated poor lawyer
ethics” (Respondent’s Response Brief at 1), that his actions amounted to “gross
negligence” (Respondent’s Answer Brief at 2), and that “[t]here are no lawyers in this
county or the surrounding counties that want to proceed with this case.” Res. Ans. Br. at
1. At an early point in this litigation she added this observation: “The argument of only
proceeding with a late hearing request due to the fact of ‘Good Cause’ is ridiculous in this
case.” Id.

Now, the concept of “good cause” has not been extensively debated in the context of 20
C.F.R. Part 498. See Peoples Benefit Services, Inc., DAB CR1525 (2006). Nevertheless,
the concept has never been defined in this forum or before the Board — no matter what
the jurisdictional context — as anything other than circumstances beyond the ability of
the party-litigant to control. Hillcrest Healthcare, L.L.C., DAB No. 1879 (2003); Glen
Rose Medical Center Nursing Home, DAB No. 1852 (2002); Hospicio San Martin, DAB
No. 1554 (1996); The Heritage Center, DAB CR1219 (2004); Hillcrest Healthcare, LLC,
DAB CR976 (2002). I apply that definition here.
6

Was the alleged inaction of retained counsel a circumstance beyond Respondent’s ability
to control? The unadorned answer is “No.” The facts asserted here by Respondent have
been offered before as a showing of good cause, but they have been firmly rejected as
inconsistent with orderly litigation. Nelson Ramirez-Gonzalez, DAB CR175 (1992);
accord, Bruce Franklin, R.Ph., DAB CR1198 (2004). A particularly cogent exposition of
the rule appears in Community Care Center of Seymour, DAB CR758 (2001): “[T]he
avoidable failure of counsel to discharge responsibilities on a [party’s] behalf or the
miscommunication between a [party] and its counsel have been found to constitute
avoidable human error, rather than circumstances beyond the [party’s] ability to control.”
Sedgewick Health Care Center, DAB CR596 (1998); Jackson Manor Health Care, Inc.,
DAB CRS545 (1998). On the plain terms of Respondent’s claim to having good cause for
filing late, I can find nothing to distinguish those cases and no reason to depart from the
precedent thereby established. But I note two additional and perhaps telling points. First,
Respondent’s Request for Hearing was back-dated to fully a week before it was mailed,
and I would find — if it were necessary to make such a finding — that her credibility on
the subject of her intentions and actions during the last four months of 2006 is subject to a
corresponding discount. Second, once the appeal period had run out and the sanctions
had become final, the I.G. sent Respondent a letter pursuant to 20 C.F.R. § 498.110
confirming that finality. LG. Ex. 7. The letter was dated October 30, 2006, and was
received by Respondent on November 7, 2006. I.G. Ex 7, at 3. Yet Respondent took no
action whatsoever toward requesting a hearing until January 11, 2007, an additional 65
days. Respondent has not shown good cause for her late filing, and the mandatory
language of 20 C.F.R. § 498.202(f)(1) controls.

VI. Conclusion

For the reasons set forth above, I grant the I.G.’s Motion to Dismiss. The hearing request
filed by Respondent Karen Kay Parham on or about January 11, 2007, must be, and it is,
DISMISSED.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In re CMS LCD Complaint:
Date: May 22, 2007
Progressive Supranuclear Palsy
Docket No. C-07-264
Decision No. CR1599

NN

DECISION DISMISSING CASE

The February 8, 2007 complaint in this matter was filed by the Medicare beneficiary’s
wife and representative. The Medicare beneficiary’s representative provided
documentation showing that she had been given general power of attorney for her
husband. In her complaint, the Medicare beneficiary’s representative appeals the Local
Coverage Determination (LCD) denial of a motorized lift chair recliner for her husband
who has progressive supranuclear palsy.

On February 28, 2007, I directed that an Order be sent to the Medicare beneficiary’s
representative explaining that her letter of February 8, 2007 was not an “acceptable”
complaint challenging a LCD. The February 8, 2007 letter was not acceptable because
the Medicare beneficiary’s representative does not identify the LCD being challenged and
does not provide acceptable clinical or scientific evidence upon which I can rely to show
that the challenged LCD is not valid. I informed the Medicare beneficiary’s
representative that she must identify the LCD by: 1) naming the contractor using the
LCD; 2) the title of the LCD being challenged; and 3) specifying the specific provision
(or provisions) of the LCD adversely affecting the aggrieved party. I informed the
Medicare beneficiary’s representative that this information was necessary, as well as a
Health Insurance Claim number, if any, for her husband to be an aggrieved party, as
defined by the regulations. Also, the February 8, 2007 letter did not meet the criteria set
out at 42 C.F.R. §§ 426.410(b)(1) and (2), which sections in turn adopt detailed content
and timeliness requirements for complaints set out in 42 C.F.R. §§ 426.400(c)(1)(v) and

(vi), (©)(2)(iv), (€)(4), and ()(6).
2

For the reasons explained below, I find that the complaint is not acceptable as a complaint
challenging a LCD. In my February 28, 2007 Order, I directed the Medicare beneficiary’s
representative that the February 8, 2007 letter would have to be amended. My February
28, 2007 Order informed the Medicare beneficiary’s representative what information was
required in order to file an acceptable complaint to challenge an LCD. The Order also
stated that, if there was no response within a reasonable time-frame, which I defined as 30
days from February 28, 2007, the regulations require that I issue a mandatory dismissal of
any complaint not successfully amended. The Order stated that “. . . the ALJ
[Administrative Law Judge] must issue a decision dismissing the unacceptable
complaint.” 42 C.F.R. § 426.410(c)(2) (emphasis added). I informed the Medicare
beneficiary’s representative that she may request one extension of time not to exceed an
additional 30 days. By letter dated March 22, 2007, the Medicare beneficiary’s
representative requested an additional 30 days in which to amend the LCD complaint
before me. I granted the extension of time. By Order dated March 29, 2007, I gave the
Medicare beneficiary’s representative until April 30, 2007 to submit an amended
complaint in this matter. As of the date of this decision, I have received no response from
the Medicare beneficiary’s representative or any other person that meets the definition of

an aggrieved party.

Assuming the February 8, 2007 letter intended to be an LCD complaint, it is unacceptable
because the Medicare beneficiary’s representative did not provide the information
necessary to show that her husband qualified as an aggrieved party. Further, the February
8, 2007 letter did not contain the information specified at 42 C.F.R. §§ 426.400(c)(1)(v)
and (vi), (c)(2)(iv), (c)(4), and (c)(6). I have afforded the Medicare beneficiary’s
representative the opportunity to amend the complaint, as required by 42 C.F.R. §
426.410(c)(1). I also granted the Medicare beneficiary’s representative additional time to
amend her complaint. The Medicare beneficiary’s representative failed to submit an
acceptable complaint within the time-frame I have established. Therefore, pursuant to 42
C.F.R. § 426.410(c)(2), I must issue a decision dismissing the complaint.

The regulations require that an ALJ’s decision contain certain provisions. 42 C.F.R. §
426.450. Pursuant to 42 C.F.R. § 426.450(a), my decision must include findings.
Therefore, as required by 42 C.F.R. § 426.450(a)(3), I find that the aggrieved party or his
representative has failed to file an acceptable complaint challenging an LCD.
Accordingly, for the reasons set forth above, I decide that this case must be dismissed.

The regulations, at 42 C.F.R. § 426.450(b), require that an ALJ’s decision contain certain
other information. This decision contains the information required by 42 C.F.R.

§ 426.450(b)(1), (2), and (6). Because I am dismissing this case for failure to file an
acceptable complaint, the information required by 42 C.F.R. § 426.450(b)(3), (4), and (5)
3

is not a part of the record before me and is not included for that reason.

The aggrieved party or his representative has 30 days from the date of this Decision to file
an appeal with the Departmental Appeals Board, in accordance with 42 C.F.R. § 426.465.

/s/
Alfonso J. Montano
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Beverly Healthcare - Ingram, ) Date: May 10, 2007

(CCN No.: 01-5189), )
)
Petitioner, )
)

“vee ) Docket No. C-06-356

) Decision No. CR1597
Centers for Medicare & Medicaid )
Services. )
)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to
impose civil money penalties against Petitioner, Beverly Healthcare - Ingram, in amounts
of $200 per day, for a period that began on January 20, 2006 and which ended on March
9, 2006.

I. Background

Petitioner is a skilled nursing facility located in Pell City, Alabama. It participates in the
Medicare program. Its participation in Medicare is governed by sections 1819 and 1866
of the Social Security Act and by federal regulations at 42 C.F.R. Parts 483 and 488.

Petitioner was surveyed for compliance with Medicare participation requirements in a
survey that ended on January 20, 2006 (January survey). The surveyors found that
Petitioner was not complying with several requirements. CMS concurred with the
surveyors’ findings to the extent that it determined that Petitioner was not complying with
four participation requirements. It concluded that Petitioner was out of compliance for a
period that began on January 20, 2006 and which ended on March 9, 2006. CMS
determined to impose remedies against Petitioner consisting of civil money penalties of
$200 per day for each day of Petitioner’s noncompliance.
2

Petitioner requested a hearing and the case was assigned to me for a hearing and a
decision. I scheduled a hearing to be held in Birmingham, Alabama on February 26,
2007. However, shortly prior to the hearing the parties informed me that they agreed that
the case could be decided based on written submissions. Consequently, I established a
briefing schedule for the parties. In addition to briefing the issues the parties offered
proposed exhibits. CMS offered a total of 26 proposed exhibits (CMS Exs.) consisting of
CMS Ex. | - CMS Ex. 26. Petitioner offered 41 proposed exhibits (P. Exs.) consisting of
P. Ex. 1 - P. Ex. 41. The parties’ exhibits include the written direct testimony of several
witnesses. I receive all of the parties’ exhibits into evidence.

IL. Issues, findings of fact and conclusions of law
A. Issues
The issues in this case are whether:

1. Petitioner failed to comply with one or more Medicare participation
requirements during the January 20 - March 9, 2006 period; and

2. Civil money penalties of $200 per day are a reasonable remedy for
whatever noncompliance that may have existed during the January 20 -
March 9, 2006 period.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this
case. I set forth each Finding below as a separate heading. I discuss each Finding in
detail.

1. Petitioner failed to comply substantially with Medicare participation
requirements during the January 20 - March 9, 2006 period.

As I discuss above, CMS determined, based on findings made by the surveyors at the
January survey, that Petitioner failed to comply substantially with four distinct Medicare
participation requirements. I sustain CMS’s determinations as follows:
3

a. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.25(c).

The regulation that is at issue here governs the prevention and treatment of pressure sores.
At subpart (1) the regulation provides that a resident who enters a facility does not
develop pressure sores unless his or her clinical condition makes the development
unavoidable. It imposes on a facility the duty to take all reasonable measures to ensure
that a resident does not develop a pressure sore. The regulation is not a strict liability
regulation but it presumes that pressure sores are avoidable. Where a resident develops a
pressure sore the burden falls on the facility to explain why the sore was unavoidable.

CMS’s case for noncompliance centers around the care that Petitioner gave to a resident
who is identified as Resident #9. This resident suffered a fracture of her right femur on
or about December 7, 2005 and was hospitalized briefly for treatment. The fracture was
treated at first with a temporary immobilizer. Some time shortly after sustaining the
injury, and prior to the resident’s discharge from the hospital, the temporary immobilizer
was replaced with a custom-fit, long-leg, hinged, removable immobilizer. CMS Ex. 14, at
20; P. Ex. 6, at 3, 5,6. The immobilizer was held together by velcro. The resident wore a
cotton stocking under the device in order to protect her skin.

The physician who put the temporary immobilizer on the resident’s leg ordered that the
resident wear it at all times but noted that it could be removed for bathing only. CMS Ex.
14, at 17. The orthopedic physician who subsequently ordered the placement of a
custom-fit immobilizer on the resident ordered that the device be worn at all times. Jd. at
19.

The resident was assessed prior to her injury as being at high risk for the development of
pressure sores. Petitioner’s staff performed an additional assessment of the resident’s
pressure sore risk on December 9, 2005, immediately after the resident returned to the
facility from the hospital. That assessment noted the fracture and listed as an
intervention: “Daily skin inspection during care/bathing by the Beverly Care Specialist
with a report to the nurse of any areas of skin breakdown or redness.” CMS Ex. 14, at 16.
The assessment also specifically referenced the resident’s fracture and the resident’s use
of an immobilizer, stating as an intervention:

Monitor skin under splint with bath[.] Notify nurse of any skin breakdown
(Velcro Immobilizer).

Id.
4

Notwithstanding these instructions there is no dispute that the resident’s immobilizer was
not removed by Petitioner’s staff at any time from December 9, 2005 until January 17,
2006. On that date the staff removed it so that the resident’s family could wash the
underlying stocking. The stocking had become soiled with feces and urine. It was then
discovered that the resident had developed two Stage II pressure ulcers and a Stage I
ulcer. CMS Ex. 4, at 6; CMS Ex. 14, at 5, 63 - 64.

The evidence that I have just summarized is strong support for a finding that Petitioner’s
staff failed to take necessary and reasonable steps to protect Resident # 9 against
developing pressure sores. Petitioner’s staff knew that the resident’s age and general
condition put her at a very high risk for developing pressure sores. The staff knew also
that the risk was enhanced by virtue of the resident’s fracture and her resulting immobility
as well as by her need to wear an immobilizer to allow healing of her fractured leg. For
that reason the staff planned to monitor the resident’s skin under the immobilizer. I find
it reasonable to infer from the resident’s care plan that the staff envisioned bathing the
resident from time to time and, in the course of doing that, removing the immobilizer and
stocking and checking the condition of the resident’s skin.

However, the staff failed to follow through on this plan. The staff never removed the
immobilizer. They left the resident’s skin essentially unattended for a period of a month
and the resident developed three pressure sores. I make no finding that the sores which
the resident developed were the direct consequence of the staff's failure to follow through
on the resident’s care plan. But, it is evident that Petitioner’s staff failed to take the steps
that were designed to protect the resident from developing sores. The staffs inaction was
a prima facie violation of 42 C.F.R. § 483.25(c) because it constituted a failure to take
necessary and reasonable measures — developed by the staff itself — to protect the resident
against developing pressure sores.

I find Petitioner’s explanations for the staff’s failure to check the resident’s skin condition
not to be persuasive. Petitioner’s primary argument is that the orthopedic physician who
placed the custom-fit immobilizer on the resident’s leg intended that the device never be
removed by Petitioner’s staff. Thus, according to Petitioner, the staff could not inspect
the resident’s skin under the immobilizer and would have no way of knowing whether the
resident was developing pressure sores. As support for this argument Petitioner relies on
the orthopedist’s order and a March 27, 2006-letter by him, in which he stated that the
resident was to wear the immobilizer at “all times” until her scheduled visit at an
outpatient clinic on January 19, 2006. CMS Ex. 14, at 19; P. Ex. 33, at 1. Additionally, it
relies on the testimony of its medical director, who averred that:
5

When a physician has given an order for a brace not to be removed, even
for bathing, nurses ordinarily should not try to remove or change the
stocking under the brace in order to avoid moving the bone.

P. Ex. 41, at 2.

However, I do not read the physician’s order as directing Petitioner’s staff absolutely
never to remove the immobilizer, “even for bathing.” More to the point, neither did
Petitioner’s staff.

The immobilizer, which was closed by velcro, was designed to be removed from time to
time. It is evident from the staff’s assessment and plans for the resident that the staff
contemplated periodic removal of the immobilizer and the underlying stocking in order to
bathe the resident and check her skin for the possible development of pressure sores.
CMS Ex. 14, at 16. That is exactly what the treatment plan for Resident # 9 stated.

Petitioner’s plan for the resident would conflict explicitly with the orthopedist’s order if,
in fact, the order was that the immobilizer never be removed. Petitioner has not explained
why its staff would write a treatment plan that would conflict with a physician’s order.
The explanation, however, is not obscure or complicated. The orthopedist’s order meant
only that the immobilizer should be left undisturbed at all times when Petitioner’s staff
was not providing care to the resident. It gave the staff leeway to remove the immobilizer
on those occasions when direct attention — such as bathing and inspecting the skin —
needed to be paid to the resident’s leg.

In fact, the staff removed the immobilizer and stocking on January 17, 2006 — two days
before the scheduled return visit to the orthopedist — so that the stocking could be
cleaned. Obviously, the staff knew that doing so would not violate the orthopedist’s
order. Otherwise it would not have removed the immobilizer.

Petitioner relies also on the testimony of the staff nurse who was responsible for skin
care. She asserted that, in a case such as that of Resident # 9, where the resident’s leg is
covered by an immobilizer, her technique for checking on a resident’s skin condition is
to:
6

... look at the areas I can see, especially where the Resident’s skin might
touch or rub against the edge of the brace. In addition, I check pedal pulses
to assure that there is adequate blood flow throughout the leg; monitor for
drainage or foul odor; consider resident complaints of pain; and the like, to
determine whether the skin may be compromised or require special
protection. I used all of these techniques in the case of Resident #9 and did
not find any potential problems.

P. Ex. 40, at 2.

However, what the nurse did with Resident # 9 expressly contradicted the staff’s skin care
plan for the resident. The plan for the resident was to monitor the resident’s skin under
the brace by checking it when the resident was bathed. CMS Ex. 14, at 16. Petitioner’s
staff clearly failed to do that and Petitioner offers no credible explanation of why it failed
to do so.

Moreover, I am not satisfied that Petitioner’s staff did even what its nurse claimed to have
done for Resident #9. The staff appeared not to have noticed that the stocking under the
immobilizer had become contaminated with feces and urine because it was the resident’s
daughter who requested that the stocking be removed so that it could be cleaned. CMS
Ex. 14, at 49. I find it hard to believe that the staff could have failed to notice the
contamination if staff members were diligently checking the resident for foul odors.
Also, the resident at times complained of pain in her right leg. Jd. at 47. Although a
complaint of pain was identified by Petitioner’s nurse as something that the staff looked
out for in assessing the condition of the resident’s skin, it is apparent that Petitioner’s
staff did not react to the resident’s complaints as signs of potential skin problems prior to
January 17, 2006.

b. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.15(e)(1).

The relevant regulation requires a facility to provide its residents with reasonable
accommodations of their individual needs and preferences except where a resident’s or
other residents’ health and safety would be endangered. CMS alleges that Petitioner
failed to comply with this requirement in that it failed, in several instances, to place call
bells within residents’ reach. CMS offered as proof the observations of the surveyors
who conducted the January survey. CMS Exs. 13; 16; 17; 18. Their observations
included the following findings:
7

+ A resident identified as Resident # 7 complained to the surveyors that the staff
frequently failed to put the call light bell with her reach. CMS Ex. 13, at 3, 5 - 6,7
-8.

+ Resident # 22 suffered from left side paralysis. However, Petitioner's staff was
observed to have placed the call bell on the left side of the resident’s pillow,
making it impossible for the resident to utilize the call bell. CMS Ex. 4, at 1; CMS
Ex. 16, at 4.

+ In the cases of several other residents Petitioner’s staff were observed to have
placed call bells in inconvenient positions or out of the residents’ reach. CMS Ex.
18, at 25 - 26. Two residents were observed to be looking for call bells but were
unable to find them due to the locations in which Petitioner’s staff placed them.
Id. at 25; CMS Ex. 17, at 4.

The evidence offered by CMS is strong prima facie proof that Petitioner failed to
accommodate the needs of several of its residents. The obvious purpose of a call bell is
to enable a resident to summon staff for assistance. Placing the bell in an inaccessible
position renders the bell useless to the resident.

Petitioner’s defense to these allegations is to argue that they offer no prima facie proof of
a potential for more than minimal harm to residents.' According to Petitioner, there is no
evidence that any resident complained that a call bell was not answered or, that residents
were unkempt or poorly cared for. I find that this argument begs the question. The issue
is not whether failure to provide residents with access to call bells caused the residents to
suffer adverse consequences. Rather, it is whether failure to provide the residents with
access to call bells put these residents, potentially, at risk for harm. The answer to that
question is evident. The whole point of having call bells in a nursing facility is to give
the residents, many of whom are severely handicapped, a way of quickly bringing
problems and needs to the staff’s attention. These problems obviously can include
problems that are health or even life-affecting. Not giving residents access to call bells
defeats the purpose of having the bells.

' Petitioner suggests, with respect to this deficiency and with respect to those
others that are based on surveyors’ observations, that it has no way of knowing whether
the surveyors’ observations were accurate. But, Petitioner did not challenge these
observations and offered no affirmative proof to show that they were inaccurate.
8

c. Petitioner failed to comply substantially with the requirements
of 42 CFR. § 483.25(a)(3).

The regulation at issue here requires a facility to ensure that a resident who is unable to
carry out the activities of daily living receives the necessary services to maintain good
nutrition, grooming, and personal and oral hygiene. CMS alleges that Petitioner failed to
comply with the requirements of this regulation because, in several instances, it failed to
provide residents with incontinence care in a manner least likely to lead to skin
breakdown. CMS offered evidence with respect to four residents, identified as

Resident #s 5, 7, 20, and 23. CMS Exs. 12; 13; 15; 17. Each of these residents was
identified by Petitioner’s staff as needing extensive or total care with respect to their
activities of daily living. These residents had continence problems. CMS offered
evidence about Petitioner’s care of these residents, consisting of surveyors’ observations
of the care that the staff provided to them:

* The staff failed to dry the legs and lower back of Resident # 5, after providing
continence care to the resident. CMS Ex. 4, at 4; CMS Ex. 12, at 5 - 6. The staff
was also observed putting a dry sheet over a visibly wet mattress. CMS Ex. 12, at
5.

* The staff failed to clean the pubic and genital areas of Resident # 7, a paraplegic
individual, after an episode of incontinence. CMS Ex. 4, at 4; CMS Ex. 26, at 2.

+ The staff applied a clean incontinence brief to Resident # 20, a demented
individual, after an episode of incontinence, without first completely washing and
drying the resident’s skin. CMS Ex. 4, at 5; CMS Ex. 15, at 8, 9 - 10.

* The staff failed to dry the skin of Resident # 23 before applying a moisture
barrier to the skin. CMS Ex. 4, at 3; CMS Ex. 17, at 4.

Petitioner’s only response to these allegations is to assert that there was no evidence cited
by the surveyors to the effect that residents remained wet or unattended for unreasonably
long periods of time. I find that not to be a defense. The issue, as stated by CMS, is
whether these residents received necessary services to maintain hygiene. Extended
periods of wetness or lengthy periods of lack of attention are not an element of CMS’s
case against Petitioner. Failure to provide continence care, as described in CMS’s prima
facie evidence, is clear proof of a failure by Petitioner’s staff to satisfy the regulatory
standard. The potential for harm here is clear. Residents who do not receive appropriate
9

continence care are, at a minimum, at risk for chafing and skin irritation. Other problems,
such as infections, are foreseeable. Petitioner has not denied that such failures of care, as
described by the surveyors, occurred nor has it offered any affirmative proof to challenge
the surveyors’ observations.

d. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.65(b)(3).

The regulation at issue here requires facility staff members to wash their hands after each
direct resident contact for which hand washing is indicated by accepted professional
practice. The evident purpose of this regulation is to prevent the spread of disease or
infection in a facility. The surveyors who conducted the January survey observed that
Petitioner’s staff failed to wash their hands or change gloves after providing incontinence
care to Resident #s 5, 7, 20, and 23. CMS Ex. 12, at 6; CMS Ex. 13, at 6; CMS Ex. 15, at
6; CMS Ex. 17, at 4; CMS Ex. 26, at 3 - 4.

Petitioner argues that these incidents, which it characterizes as “isolated,” fail to
demonstrate the potential for more than minimal harm to residents in the absence of any
evidence of residents remaining wet, complaining, or of proof that infections were
spreading as a consequence of poor staff hygiene. I find this argument to be without
merit. Petitioner seems to be saying that a deficiency cannot exist unless CMS provides
evidence of a causal relationship between poor hygiene and the actual spread of infection
at Petitioner’s facility or other adverse consequences. But, actual harm is not a necessary
element of CMS’s case. The issue here is whether the failure by the staff to wash their
hands after providing incontinence care posed the potential for more than minimal harm
to residents. I find such potential to be obvious. As CMS asserts, citing the Centers for
Disease Control:

Handwashing is the single most important procedure for preventing
nosocomial infections.

CMS Ex. 21, at 7.

2. Civil money penalties of $200 per day for each day of the January 20 -
March 9, 2006-period are reasonable.

Petitioner did not offer argument or evidence concerning the duration of its
noncompliance. It did not assert, for example that, if any deficiency was present at its
facility as of January 20, 2006 it corrected that deficiency prior to March 9.
Consequently, I find that CMS’s determination as to the duration of Petitioner’s
noncompliance is administratively final.
10

The remaining issue is whether civil money penalties of $200 for each day of the
noncompliance period are reasonable. I find that they are.

The penalties that CMS determined to impose against Petitioner fall within the range of
civil money penalties that are reserved to remedy deficiencies that do not put residents of
a facility in a state of immediate jeopardy. The range for such penalties is between $50
and $3,000 per day. 42 C.F.R. § 488.438(a)(1)(ii). I note at the beginning of this
discussion that the penalties that CMS determined to impose are extremely modest,
falling at the bottom end of the non-immediate jeopardy range and, comprising less than
seven percent of the maximum permissible non-immediate jeopardy penalty amount.

Regulations establish criteria for evaluating penalty amounts. The criteria include: the
seriousness of the noncompliance; the facility’s noncompliance history; the facility’s
culpability; and, the facility’s financial condition. 42 C.F.R. §§ 488.438(f)(1) - (4);
488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). Here, neither CMS
nor Petitioner presented evidence or argument relating to any of the regulatory criteria
other than the seriousness of Petitioner’s noncompliance.

I conclude that Petitioner’s noncompliance was relatively serious. The potential for harm
resulting from the deficiencies that I discuss above was palpable. The potential harm
included the risk that Petitioner’s failure to look after its residents’ skin condition might
lead to the development of pressure sores by residents. It also included the probability
that residents in distress would be unable to communicate their needs. It included the risk
that incontinent residents might develop skin problems. And, finally, it included the
heightened possibility that infections might be spread by Petitioner’s staff.

Those risks were evident. Any one of the deficiencies that I have found that Petitioner
manifested was, in and of itself, of sufficient gravity to justify the very modest penalties
that CMS determined to impose. Collectively these deficiencies were more than
sufficient to justify the penalties of $200 per day.

Petitioner argues that CMS failed to prove that residents were actually harmed by its
noncompliance and, for that reason, it asserts that civil money penalties should not be
imposed against it. It argues that the surveyors originally found deficiencies other than
those that were the basis for CMS’s final remedy determination and that these
deficiencies were ultimately deleted. It contends that I should not sustain penalties
against it because the aggregate level of noncompliance, minus the deleted deficiencies, is
lower than that which was originally determined. Also, Petitioner argues that CMS did
not prove prima facie that the failure to provide planned skin care for Resident # 9
actually harmed the resident, as alleged, and it argues that it should benefit from this
asserted failure of proof.
11

I find these arguments to be unpersuasive. My conclusion that civil money penalties of
$200 per day are reasonable is not based on findings that residents were harmed by
Petitioner’s noncompliance. In this case it is the potential for harm that justifies the
penalty amounts. I make no findings here that Petitioner’s noncompliance actually
harmed residents because it is unnecessary that I do so in order to conclude that the
penalty amount is reasonable.

Moreover, the fact that there may have, at one time, been more serious findings of
noncompliance than those that are the basis for my decision is irrelevant. Implicit in
Petitioner’s arguments is the assumption that my review of penalty determinations is
some type of appellate review in which I measure the reasonableness of the penalties
against the evidence that CMS had before it at the time it made its determinations.
Petitioner’s logic evidently is that I am obligated to reduce a penalty amount where I find
fewer, or less serious, deficiencies than those upon which CMS originally based its
remedy determination. That is incorrect. I conduct a de novo review of the evidence
relating to penalty amount. Here, my decision that penalties of $200 per day are
reasonable is based solely on the evidence before me and without regard to how CMS
might have reviewed the same or different evidence.

/s/

Steven T. Kessel
Administrative Law Judge