Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Aspen Grove Home Health, ) Date: January 7, 2009
(CCN: 13-7104), )
)
Petitioner, )
) Docket No. C-07-186
“Vee ) Decision No. CR1878
)
Centers for Medicare & Medicaid )
Services. )
)
DECISION

Petitioner, Aspen Grove Home Health, was not in substantial compliance with Medicare
conditions of participation for home health agencies and there was a basis for termination
of its provider agreement effective November 28, 2006.

I. Background

Petitioner, located in Twin Falls, Idaho, was a home health agency (HHA) authorized to
provide home health services to Medicare eligible beneficiaries and to receive
reimbursement for those services from Medicare. The Idaho Bureau of Facility Standards
(the state agency) completed a recertification survey of Petitioner on August 30, 2006,
and determined that Petitioner was not in substantial compliance with nine conditions of
participation. Joint Stipulation (Jt. Stip.); Centers for Medicare & Medicaid Services
(CMS) Exhibit (CMS Ex.) 38. On October 5, 2006, Petitioner submitted a plan of
correction and allegation of compliance to the state agency, which were rejected by the
state agency on October 10, 2006. Jt. Stip.; CMS Exs. 1, 39. On November 3, 2006,
CMS notified Petitioner that based on the findings of noncompliance, Petitioner’s
provider agreement would be terminated effective November 28, 2006. Jt. Stip.; CMS
Ex. |. CMS notified Petitioner by letter dated November 15, 2006, that Petitioner’s plan
of correction dated November 12, 2006 and its allegation of compliance dated November
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13, 2006, were accepted and that an unannounced revisit survey would be conducted
before the proposed termination date. Jt. Stip.; CMS Ex. 2. From November 20 through
22, 2006, CMS and state agency surveyors conducted a revisit survey and concluded that
Petitioner was not in substantial compliance based upon violation of three conditions of
participation. Jt. Stip.; CMS Exs. 3, 4. On December 7, 2006, CMS notified Petitioner of
its decision to continue the termination process originally described in its November 3,
2006 termination notice to Petitioner and that termination would occur effective
November 28, 2006. Jt. Stip.; CMS Ex. 3.

By letter dated January 3, 2007, Petitioner requested review by an administrative law
judge (ALJ) and the matter was assigned to me. The parties stipulated that only the
survey completed on November 22, 2006, and the deficiencies cited therein are at issue
before me. Jt. Stip.; Tr. 15-21. I convened a hearing in Boise, Idaho, September 5
through 7, 2007. CMS offered 48 exhibits, CMS Exs. | through 46 were admitted with
the exception of the following pages of CMS Ex. 46: pages 72-135, 162-168, 172-208,
215-220, 262-268 and 271-297.' Tr. 30-33. Petitioner offered 18 exhibits. Petitioner
Exhibits (P. Exs.) 2, 3, 4, 6, 12, 16, 17, and 18 were admitted in their entirety. P. Ex. 1
and P, Ex 15 were not admitted; P. Ex. 5, pp. 3-107 were admitted; P. Ex. 7, pp. 7-19
were admitted; P. Ex. 8, pp. 2-49 were admitted; P. Ex. 9, pp. 2-57 were admitted; P. Ex.
10, pp. 2-12 were admitted; P. Ex. 11, pp. 3-9 were admitted; P. Ex. 13, pp. 2-3 were
admitted; and P. Ex. 14, pp. 1-20 were admitted. Tr. 557-69, 678, 733. The parties
submitted post-hearing briefs and post-hearing reply briefs.

II. Discussion
A. Issue

Whether there was a basis for termination of Petitioner’s Medicare provider
agreement.

B. Applicable Law

The Social Security Act (Act) sets forth requirements for home health agencies
participating in the Medicare and Medicaid programs, and authorizes the Secretary of

' CMS withdrew CMS Exs. 47 and 48 and they were not admitted or considered.
? CMS moved to strike all or at least pages 31-56 of Petitioner’s response

(Petitioner’s post-hearing reply brief) to CMS’s post-hearing brief because Petitioner’s
brief exceeded the page limit set for post-hearing briefs. I deny the CMS motion.
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Health and Human Services to promulgate regulations implementing the statutory
provisions. Act, §§ 1861(m) & (0), and 1891 (42 U.S.C. §§ 1395x(m) & (0); § 1395bbb).
The Secretary's regulations governing HHA participation in the Medicare program are
found at 42 C.F.R. Part 484.

In order to participate in the Medicare program and obtain reimbursement for its services
a HHA must be in compliance with all applicable “conditions” as specified in 42 C.F.R.
Part 484. 42 C.F.R. § 488.3(a)(2). Periodic review of compliance with the conditions of
participation is required and such reviews or surveys are generally conducted by the state
agency. Based upon its survey, the state agency either certifies compliance or
noncompliance of the surveyed provider. 42 C.F.R. §§ 488.20, 488.24, 488.26.

The state agency certifies that a HHA is not in compliance with the conditions for
participation when “the deficiencies are of such character as to substantially limit the
provider’s . . . capacity to furnish adequate care or which adversely affect the health and
safety of patients.” 42 C.F.R. § 488.24(b). Whether or not there is compliance with a
condition of participation depends upon the “manner and degree to which the provider . . .
satisfies the various standards within each condition.” 42 C.F.R. § 488.26(b); CSM Home
Health Services, DAB No. 1622, at 6-7 (1997). The state agency is to assess the
provider’s performance against the appropriate standards to determine and document the
nature and extent of any deficiency and to assess the need for correction or improvement.
Surveyors are required to “directly observe the actual provision of care and services to
residents, and the effects of that care, to assess whether the care provided meets the needs
of individual residents. .. .” 42 C.F.R. § 488.26(c)(2). Furthermore, deficiencies that
might not amount to a violation of a condition of participation if considered individually,
should also be considered collectively with all other deficiencies to determine whether a
condition of participation has been violated. CSM Home Health Services, DAB No.
1622, at 7. CMS is authorized to terminate a provider agreement when the provider no
longer meets the requirements of the Act or fails to meet the conditions of participation,
among other grounds listed in the regulation. 42 C.F.R. § 489.53. The Departmental
Appeals Board (the Board) has interpreted 42 C.F.R. § 488.28 to permit CMS to
terminate a provider where there are repeated standard-level violations, none of which
rises to a condition-level violation either singly or collectively, if the provider does not
timely submit a plan of correction acceptable to CMS and implement the accepted plan
within a reasonable period. CSM Home Health Services, DAB No. 1622, at 19.
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A provider terminated for noncompliance by CMS has a right to have the determination
reviewed in accordance with the procedures of 42 C.F.R. Part 498. 42 C.F.R. §§ 488.24,
489.53(3), 498.3(b)(8). The ALJ reviewing the termination may review the
characterization of deficiencies as condition or standard-level violations. The ALJ may
also determine whether termination was appropriate given the deficiencies found on
teview. CSM Home Health Services, DAB No. 1622, at 6-7.

CMS bears the burden of producing evidence sufficient to establish a prima facie case.
CMS must set forth the basis for its determination with sufficient specificity for a
petitioner to respond and come forward with evidence related to the disputed findings.
The evidence set forth by CMS must be sufficient to establish a prima facie case that
CMS had a legally sufficient basis to terminate the petitioner’s provider agreement. In
order for a petitioner to prevail, the petitioner must prove by a preponderance of the
evidence that it was in substantial compliance with the relevant statutory and regulatory
provisions. Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), affd Hillman
Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB)
(D.N.J. May 13, 1999).

C. Findings of Fact, Conclusions of Law, and Analysis
My conclusions of law are in bold followed by factual findings and analysis.

The regulations at 42 C.F.R. Part 484 establish the conditions of participation and
standards by which HHA compliance with the Medicare program is determined. The
standards set forth in the regulations are essentially the yard sticks by which surveyors
measure the level of compliance of the HHA. If HHA performance does not measure-up
to the regulatory standard, a deficiency exists. If a deficiency is found the question is
whether that deficiency alone or considered in combination with another deficiency is “of
such character as to substantially limit the provider’s . . . capacity to furnish adequate care
or which adversely affect the health and safety of patients... .” 42 C.F.R. § 488.24(b). If
the provider’s capacity to furnish adequate care is substantially limited or if the health and
safety of patients is adversely affected then a condition-level deficiency exists and
termination must occur. If no condition-level deficiency exists, CMS may still consider
whether one or more standard-level deficiencies are repeated on survey and resurvey and,
if no correction has occurred, CMS may declare the provider agreement terminated on
that basis. CMS argues in this case that there were condition-level deficiencies and that
Petitioner failed to correct standard-level deficiencies and return to substantial
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compliance. However, if I determine that Petitioner failed to meet even one condition of
participation, I may conclude that there is a basis for termination of Petitioner’s provider
agreement. Therefore, it is not necessary for me to consider all the conditions of
participation or repeated standard-level deficiencies cited by CMS as a basis for
termination.

1. Petitioner violated the condition of participation at 42 C.F.R.
§ 484.30 (Tag G168).

2. Petitioner’s violation of 42 C.F.R. § 484.30(a) adversely affected the
health and safety of patients.

3. Petitioner’s violation of 42 C.F.R. § 484.30(a) shows that
Petitioner’s capacity to furnish adequate care was substantially limited.

4. There was a basis for termination of Petitioner’s provider
agreement effective November 28, 2006.

A HHA must meet the condition of participation that requires an HHA to furnish skilled
nursing services by or under the supervision of a registered nurse (R.N.) and in
accordance with a patient’s plan of care. The two standards set forth under this condition
of participation establish the specific duties of a registered nurse and a licensed practical
nurse (L.P.N.). 42 C.F.R. § 484.30.

The surveyors who conducted the survey that ended on November 22, 2006, the results of
which are reported in a Statement of Deficiencies (SOD) bearing that date, concluded that
Petitioner violated 42 C.F.R. § 484.30 (Tag G168).> CMS Ex. 4, at 24-61. The SOM lists
15 separate Tags, G168 through G183, under the condition of participation Tag G168. In
this case, the surveyors concluded that Petitioner violated both standards of participation
citing the violations under Tags G169, G170, G172 through G177, and G180. The
surveyors concluded that the violation of the standards amounted to a condition-level
violation of 42 C.F.R. § 484.30 (Tag G168). I conclude that the deficiencies cited by the
surveyors under Tags G172 through G174 amply demonstrate the standard-level violation

> The Tag designation is a reference to the applicable part of the guidance to
surveyors found in the State Operations Manual (SOM), App. B (Rev. 11, Aug. 12,
2005). Although the SOM is not promulgated as a regulation and is not binding as law, it
reflects the CMS interpretation of the survey regulations and conditions and standards of
participation in the Act and regulations, which are enforceable.
6

of 42 C.F.R. § 484.30(a). Furthermore, the three deficiencies I discuss are deficiencies
“which adversely affect the health and safety of patients” and they amount to

a condition-level violation of 42 C.F.R. § 484.30. I also conclude that the three
deficiencies discussed amply demonstrate that Petitioner’s capacity to furnish adequate
care was substantially limited by the failures of its R.N. staff, supporting my conclusion
that there was a condition-level violation of 42 C.F.R. § 484.30. Accordingly, I conclude
it unnecessary to discuss other alleged standard or condition-level deficiencies cited by
the survey that concluded on November 22, 2006.

(a) Tag G172

The standard at 42 C.F.R. § 484.30(a) requires that a R.N. regularly re-evaluate the
nursing needs of the patients. The surveyors found that Petitioner failed to ensure that a
R.N. regularly re-evaluated the nursing needs of seven of the patients whose clinical
records were fully reviewed. CMS. Ex. 4, at 31. CMS presented medical evidence for all
seven residents (CMS Exs. 24-28, 31-32), but I find it sufficient to discuss only the cases
of Patients 4, 9, and 14.

Patient 4 was 94 years old and lived in an assisted living facility. She began receiving
care from Aspen Grove Home Health on October 27, 2006. Her “Home Health
Certification and Plan of Care” (Plan of Care) for the period October 27, 2006 through
December 25, 2006, indicated that she was admitted for home health services for
management of a wound and hematoma on her right knee and monitoring for congestive
heart failure (CHF). CMS Ex. 4, at 34; CMS Ex. 25, at 7-8, 10-11. Her physician
ordered skilled nursing services | to 2 times a week for 60 days with an authorization for
three additional visits as necessary. The order directed that the skilled nurse cleanse the
area with sterile water, apply DuoDerm with skin prep and cover with tape. The dressing
was to be changed as needed and the nurse was to monitor for signs and symptoms of
infection. CMS Ex. 25, at 27.

The surveyors state in the SOD that a home visit note for November 13, 2006
documented that the dressing for the knee wound was in place and that there was no
increase in swelling or pain, but the document did not reflect that the wound was
examined or the dressing changed. The surveyors also state that the home visit note for
November 17, 2006 documented that the dressing was changed, there were no signs or
symptoms of infection, a tracing of the wound was done, but there was no documentation
of the actual status of the wound, such as wound bed, the presence or absence of drainage
or odor, the condition of surrounding skin, the presence of pain or increased temperature,
or comparison of the wound size to previous measurements. A surveyor visited the
patient with a R.N. on November 20, 2006. The surveyor noted a foul odor and dark red
7

drainage from the wound outside the dressing. The R.N. indicated that she would change
the dressing the next day, but the surveyor asked that the dressing be changed
immediately. When the dressing was removed there was a large amount of odorous
sanguineous drainage and the wound bed was covered with slough. The R.N. replaced
the dressing but did not measure the wound, touch the surrounding skin, or ask the patient
about local pain or tenderness. CMS Ex. 4, at 34-35. The surveyors’ allegations in the
SOD are consistent with Petitioner’s clinical record for Patient 4. CMS Ex. 25, at 9, 12,
14-16, and 18-19. The surveyors concluded that the R.N. had not regularly reevaluated
the patient’s nursing needs.

I conclude that the evidence is consistent with the conclusion that the R.N. did not
regularly reevaluate Patient 4’s nursing needs. Patient 4 was receiving home health
services from Petitioner because the assisted living facility contacted this patient’s doctor
to obtain assistance dressing Patient 4’s right knee wound. CMS Ex. 25, at 28. Witha
person of Patient 4’s age, it was of particular concern that someone be able to cleanse the
wound and properly apply a new dressing as well as monitor the wound for signs and
symptoms of infection, as neither Patient 4 nor the assisted living facility was able to do
the necessary treatment and monitoring.

The R.N. notes from the skilled nursing visits do not demonstrate that physician ordered
services, which required the R.N. to properly evaluate and assess Patient 4’s wound each
visit and cleanse and redress it as necessary, were in fact being done. CMS Ex. 25; P Ex.
13. The documentation from the November 11 and November 17, 2006 visits does not
reflect a thorough evaluation of the wound. The record for the November 13, 2006 visit
indicates that the DuoDerm dressing was not changed, yet the R.N. reported that she
assessed the wound to the right knee. CMS Ex. 25, at 18. It would be impossible to
thoroughly assess the wound without removing and changing the dressing, as the
DuoDerm dressing is not transparent. Moreover, the record of the November 13, 2006
home visit to Patient 4 does not contain, contrary to Petitioner’s argument, complete
evaluation of Patient 4’s wound. There is no wound assessment indicating the stage of
the wound, its length and width, its depth, whether it was open, whether there was
drainage and in what amount, nor was there a record of other similar types of assessments
that would ordinarily be done when assessing a serious wound in an elderly patient. CMS
Ex. 25, at 17-19. Petitioner argues that it provided the requisite care to Patient 4 on
November 17, 2006 because the R.N. checked off on the home visit form that she
changed the dressing and that there were no signs or symptoms of infection. CMS Ex. 25,
at 13-15; Tr. 390-91. While the documentation of the home visit for November 17
includes a Wound Measuring Guide with a sketch of the wound’s size, there is no
indication of the staging of the wound, its color, its depth, its drainage, the drainage type,
whether there is an odor, erythema, eschar, undermining and/or tunneling-the kinds of
8

assessments that, at the very least, should be made when assessing a wound. CMS Ex.
25, at 16. I also note that a comparison of the rough sketch done by the R.N. on
November 17, 2006 with the tracing of the wound made on November 9, 2006 indicates
that the open area of the wound had become bigger.’ CMS Ex. 25, at 16 and 29. The
increased open area should have triggered a comment in the home visit documentation or
perhaps a consult with Patient 4’s physician, but there is no comment in the documents
and there was no consultation.’ Just three days later, the surveyor accompanied the R.N.
to visit Patient 4. The surveyor immediately noticed dark red stains showing through the
non-transparent DuoDerm dressing and the surveyor detected an odor emanating from
Patient 4’s leg. CMS Ex. 25, at 22; Tr. 342-43. When the surveyor alerted the R.N. to
her observations, the R.N. indicated that she need not change the dressing or look at the
wound, but that it would be done the next day. It was only at the surveyor’s insistence
that the R.N. proceeded to change the dressing and look at the wound. When the old
dressing was removed, a large amount of sanguineous fluid drained from the wound and
the wound was covered with slough.© CMS Ex. 25, at 23; Tr. 344. The surveyor was
concemed that the wound may not have been adequately cleansed because it was done so
quickly she did not see it done. She was particularly concerned because the R.N. did not
examine the wound. The R.N. did not palpate the area to find out the status of the
surrounding skin, whether other materials came loose from the wound, whether there was
undermining indicating extension of the wound, and whether the local area of the wound
was warm, which might indicate inflammation or perhaps infection. Tr. 345.

* The R.N. wrote a “Patient Update” on November 21, 2006 after the unscheduled
visit with the surveyor to see Patient 4. The update was sent to Patient 4’s physician and
states that there was a decrease in the size of the wound since Patient 4 was first admitted
for HHA care on October 27 and that the change in the wound discovered on the
November 20 visit was a big change in Patient 4’s condition. However, a visual
comparison of the the Ez Graph wound assessment tracings done on November | to the
ones done on November 9 and November 17, 2006 do not indicate that the size of the
open wound was smaller and it appears that just the opposite was true. Compare CMS
Ex. 25, at 26 with CMS Ex. 25, at 16 and 29.

5 Arguably, one purpose of skilled nursing home health care services for the home
bound patient is to provide reliable information for the treating physician so that proper
care planning can be done and interventions implemented if necessary.

6 “Slough” was described as dead adherent tissue which can occur when there is
infection and it shows there is inflammation to the wound due to dead white blood cells.
Tr. at 344.
9

I conclude that Petitioner failed to ensure that its R.N. properly reevaluated Patient 4's
nursing needs each visit. There was an adverse effect upon the health of Patient 4.

Patient 9 was a 61-year-old male, admitted for home health services on October 8, 2006
with a primary diagnosis of inoperable lung cancer. He also had a diagnosis of chronic
obstructive pulmonary disease (COPD) for which he required continuous oxygen. He had
a poor prognosis with a life expectancy of six months or less. His plan of care for the
October 8 through December 6, 2006 certification period included an order for skilled
nursing to assess his pain level every visit and to teach him and his care-givers about
taking his pain medications when his pain exceeded a level four on a scale of one to ten
(ten being the highest level of pain) before his pain became too severe. The skilled nurse
was to notify his doctor if there were any concerns with this. CMS Ex. 28, at 49, 138,
142. The goal was to try to keep Patient 9’s pain level at a moderate but bearable level
(less than a level five on a scale of one to ten). CMS Ex. 28, at 50, 139, 142, 161.

The surveyors concluded that Petitioner’s nursing staff did not follow Petitioner’s policy
for assessment of pain. CMS Ex. 4, at 38. Petitioner’s pain assessment policy, revised
October 1, 2006 and effective November 7, 2006, requires that a comprehensive
assessment of a patient’s pain be done that includes the following elements: intensity,
location, frequency, character, current therapy, effectiveness of therapy, and influence of
pain on movement and activity. CMS Ex. 20. The surveyors concluded that assessment
of Patient 9’s medical and nursing needs related to pain was insufficient, consistent with
their conclusion that the R.N. had not regularly reevaluated Patient 9’s needs regarding
pain control. CMS Ex. 4, at 30, 38.

I conclude that the surveyors’ evaluation was correct. When Patient 9 was admitted for
home health services on October 8, 2006, he reported constant intractable pain at least
daily that affected his sleep, appetite, physical or emotional energy, concentration,
personal relationships, emotions, and physical activity. CMS Ex. 28, at 155. He
complained of a burning pain in his right upper chest at an intensity of eight on a scale of
one to ten with ten being the worst pain. CMS Ex. 28, at 142, 161. No other location for
pain was identified in his intake assessments. The certification and plan of care for the
period October 8 to December 6, 2006, did not identify locations for pain, but directed
skilled nursing to assess pain level every visit, to instruct the patient and care-giver on
taking pain medication before pain became severe with the goal of keeping the intensity
of pain less than five on a ten point scale, and the nurse was to contact Patient 9’s
physician with any concerns. CMS Ex. 28, at 138-39.

On November 5, 2006, the R.N. noted that Patient 9 reported no pain, he had pain
10

medication to take as necessary, but the R.N. also noted that Patient 9 complained of pain
daily but not constantly. There is no indication that the R.N. assessed the location of the
pain when it occurred daily or the effectiveness of Patient 9’s pain medication in relieving
the pain. The nurse noted that Patient 9 had a new pressure ulcer over the coccyx but
does not indicate if Patient 9 complained of pain associated with the ulcer. The R.N.
noted that she did teaching on dressing the ulcer, but no indication that she did teaching
on managing pain. CMS Ex. 28, at 107-12.

On November 7, 2006, a L.P.N. visited Patient 9. She recorded that she assessed Patient
9's pain level, but she made no entries indicating whether or not he had any pain nor did
she note any of the other assessment criteria specified in Petitioner’s pain policy that
became effective that day. The L.P.N. also indicated that pain management training was
done. CMS Ex. 28, at 102-06.

On November 14, 2006, Patient 9 was admitted to the hospital because he was more short
of breath than usual and his intravenous line had come out. He reported no chest or
abdominal pain and specifically no pain related to his lung cancer. He was diagnosed
with left-sided pneumonia and started on an antibiotic. CMS Ex. 28, at 92-93.

On November 15, 2006, Patient 9 received a resumption of care assessment by
Petitioner’s R.N., who noted that he complained of pain at level eight all the time, that the
pain affected sleep, appetite, physical or emotional energy, concentration, personal
relationships, emotions, and physical activity. CMS Ex. 28, at 56-57, 76-77. The R.N.
recorded that Patient 9’s “main pain is in the coccyx at 8.” CMS Ex. 28, at 65; CMS Ex.
28, at 61. The R.N. did not indicate that she assessed whether Patient 9 had pain in other
locations associated with his lung cancer or pneumonia or whether his present medication
was effective to keep his pain at an intensity level of less than five. CMS Ex. 28, at 64-
68, 73-85, 55-60. The R.N. circled the word “Done” on the list of interventions at the end
of the line that requires the nurse to assess pain and do teaching on pain control every
visit and to notify the M.D. if there are concerns. However, the evidence does not include
a document reflecting consultation with the physician or a physician’s order on November
15. A physician’s order dated November 17, 2006 does not address pain. CMS Ex. 28, at
120.

On November 16, 2006, Patient 9 was readmitted to the hospital with complaints of
shortness of breath. He was assessed as suffering pneumonia and anxiety, in addition to
terminal lung cancer and end-stage COPD. CMS Ex. 28, at 43-48. On November 17,
2006, someone allegedly broke into his house and stole approximately 40 pills of his
oxycodone, a powerful pain reliever. CMS Ex. 28, at 38, 115-17. On November 20,
2006, Petitioner’s R.N. did a resumption of care assessment. The R.N. noted Patient 9
1

complained of intractable pain at an intensity of ten, that was constant, not easily relieved,
and affected all functional areas. The R.N. did not specify the location of the pain or the
effectiveness of pain medication but, she did note that Patient 9’s oxycodone had been
stolen. CMS Ex. 28, at 16, 30-34

The records of the home visits by L.P.N.s on October 31, November 3, November 10, and
November 13, 2006, provide no better assessments than those already described.

Although Patient 9 was terminal, management of his pain, whether from his lung cancer
or coccyx wound, was clearly an important part of his plan of care. The skilled nurses,
L.P.N.s and R.N.s, did not perform assessments as prescribed by Petitioner’s policy.
Petitioner has presented no evidence that, if Patient 9’s complaint of severe coccyx pain
was ever reported to his physician, that the physician responded. Petitioner has presented
no evidence that any action was taken to replace the stolen oxycodone, although the
record indicates that Patient 9 did have other pain medication that he used. I conclude
that Petitioner’s R.N.s did not regularly reevaluate Patient 9’s nursing needs with respect
to pain control. The health of Patient 9 was adversely affected.

Patient 14 was an 81-year-old female whose start of care with Petitioner was April 6,
2006. Her diagnoses included a history of urinary tract infection, diabetes with a history
of hypoglycemia, and malaise and fatigue. Her blood glucose levels were documented as
chronically high, with the lowest level at 171 and the highest level at 585 for the period
between November 8 and November 15, 2006. She also had two blood glucose readings
in the 400’s and three in the 300’s. CMS Ex. 4, at 32; CMS Ex. 31, at 18-25, 105.

The R.N. visited Patient 14 on October 23, 2006. She noted that Patient 14’s son, who
was her care-giver, refused to get-up to give Patient 14 insulin so the nurse did. She also
noted that Patient 14 had been sitting in urine. CMS Ex. 31, 62-65. On November 8,
2006, the R.N. called Adult Protection. CMS Ex. 31, at 54. On November 8, 2006, a
home aide reported to the R.N. that Patient 14’s blood sugar was high twice and, the
second time, the care-giver refused to get up and give Patient 14 insulin. The R.N. noted
she was concerned about medical management and she called the social worker and the
two decided to call Adult Protection again. CMS Ex. 31, at 55. The R.N. noted on
November 13, 2006 that Patient 14’s main care-giver was incarcerated for six months and
the patient’s granddaughter was going to move the patient to her home and care for her.
The R.N. noted that she would notify Medicaid, the physician, and Adult Protection. The
R.N. noted she spoke with the granddaughter and arranged for her to meet with the social
worker, but there was no mention of the R.N. visiting. CMS Ex. 31, at 56, 113. The R.N.
notified the physician on November 14, 2006 indicating the social worker would visit
with the granddaughter and Patient 14, but no mention of the R.N. visiting. CMS Ex. 31,
12

at 43. The R.N. updated the doctor on November 17, 2006, indicating that she spoke with
the granddaughter, the new primary care-giver for Patient 14, and she requested education
about diabetes and appropriate diet, and the R.N. coordinated with the dietician. The
R.N. also reported that Patient 14 was having difficulty adjusting to the granddaughter’s
young children and had pushed the young son, that Patient 14 refused to permit the
granddaughter to help with care, and that Patient 14 was causing disharmony in the home.
The R.N. suggested a meeting with her, the social worker, and others, but no schedule for
the meeting was set. CMS Ex. 31, at 41. The record documents that a L.P.N. visited
Patient 14 twice a week for the period of October 25 through November 20, 2006. The
record does show that the R.N. reviewed the L.P.N.’s reports of the home visits and also
made a joint visit on November 3, 2006 for the purpose of assessing by direct observation
the performance of the L.P.N. However, there is no record of any further visits by the
R.N. at which the R.N. could have or did evaluate or reevaluate Patient 14 after the visit
inade by the R.N. on October 23, 2006. CMS Ex. 31, at 61-62; CMS Ex. 31, at 66-101; P
Ex. 8.

The surveyors concluded that the R.N. had not reevaluated Patient 14’s nursing needs
between October 23, 2006 and November 22, 2006, the last day of the survey. The
surveyors also concluded that the R.N. had not evaluated Patient 14’s current
environment and the new care-giver’s ability to meet Patient 14’s needs, particularly her
diet. CMS Ex. 4, at 33-34. Petitioner argues that the note by the R.N. dated November 7,
2006 indicates that teaching was done regarding diabetic issues; that if an R.N. visited
every two weeks the next visit would have been November 21; that there is evidence the
new care-giver received training from the L.P.N. regarding diet and diabetes; and that
blood glucose levels were better. P. Brief, Ex. A, at 19-20. However, Petitioner points to
no evidence that the R.N. actually reevaluated Patient 14’s nursing needs between
October 23 and November 22, 2006.

The L.P.N. visits are well documented and it is clear that Patient 14 was receiving nursing
services. However, the standard of participation requires that all assessments and
evaluations and reevaluations of a patient’s nursing needs be performed by the R.N.
Contrary to the suggestion of Petitioner, there is no 14-day period for reevaluation
specified by the regulation. Rather, the regulation specifies that reevaluation by the R.N.
is to be done regularly, without specifying frequency. However, in the case of Patient 14
I concur with the surveyors’ evaluation that a reevaluation of Patient 14 was required, but
not done. The need for the reevaluation was obvious based on the following: the care-
giver son had demonstrated his unreliability to get out of bed, to keep Patient 14 clean and
dry, and to administer insulin when needed; Patient 14’s blood glucose levels were clearly
out of control; the care-giver became the granddaughter upon incarceration of the son;
Patient 14 had to be moved to the new environment in the home of the care-giver who
13

had small children; and the care-giver specifically requested training in how to care for
Patient 14. To be sure, the R.N. did react to the circumstances of Patient 14 by calling
and notifying Adult Protection, the physician, the social worker, and the new care-giver.
But there is no explanation for why the R.N. did not go see for herself and reevaluate the
needs of Patient 14, despite the obvious signs that reevaluation was necessary. Petitioner
14’s uncontrolled blood glucose levels and the neglect of her care-giver son posed
significant potential for harm.

Based upon the examples of the three patients, I conclude that Petitioner violated 42
C.F.R. § 484.30(a) because it did not ensure that the needs of its patients were being
regularly reevaluated by an R.N. For each of the patients discussed, the failure of the
R.N. to regularly reevaluate adversely affected the health and safety of each patient and
either harmed or had the potential for harm to each patient. Petitioner’s failure to ensure
that its R.N. regularly reevaluated these patients’ needs also limited Petitioner’s capacity
to furnish adequate care.

(b) Tag G173

The regulation requires that a R.N. initiate the plan of care for each patient and any
necessary revisions to that plan based on the changing needs or changing condition of the
patient. 42 C.F.R. § 484.30(a). The surveyors cite the example of Patient 9 as the basis
for their conclusion that Petitioner violated the standard. The surveyors found that Patient
9 was hospitalized on November 1, 2006, suffering fecal impaction for which he was
given a potent sedative and manually disimpacted. However, despite the emergency room
visit for fecal impaction, Petitioner did not revise Patient 9’s plan of care related to bowel
management. CMS Ex. 4, at 41-45; Tr. 395-96.

The case of Patient 9 was discussed under Tag G172. In addition to his terminal lung
cancer and end-stage COPD, he had problems with constipation. His plan of care
provided for skilled nursing services one to three times a week for the 60-day certification
period October 8 through December 6, 2006, required that skilled nursing was to teach
Patient 9 and his care-giver regarding bowel routine, medication, and diet; to assess
bowel movements and concerms regarding constipation; and to notify the physician with
any concerns. CMS Ex. 28, at 140. Constipation was a significant issue for this patient
and his plan of care listed constipation as a secondary diagnosis. CMS Ex. 28, at 140.
The surveyors observed that Patient 9 was on two opiate analgesics, oxycodone and
morphine sulphate, which are known to cause constipation. CMS Ex. 4, at 42. The R.N.
reported to the physician on October 10, 2006, that Patient 9 had not had a bowel
movement in four to five days, he refused an enema by the R.N., the wife gave the enema
and reported no results, the nurse instructed the wife to give Patient 9 warm prune juice
14

and milk of magnesia, and the R.N. advised the doctor that she may need an order for
magnesium citrate. CMS Ex. 28, at 142. The physician issued an order for magnesium
citrate and sorbitol on October 13, 2006. CMS Ex. 28, at 137. Patient 9 was hospitalized
on November |, 2006, for fecal impaction. At the time of his hospitalization he indicated
he had not had a bowel movement in a week. P. Ex. 5, at 26; CMS Ex. 28, at 123. The
emergency room physician, upon Patient 9’s release after manual extraction, indicated
that Patient 9 should continue with laxatives and stool softeners and follow-up with his
physician or in the emergency room for further evaluation and treatment. P. Ex. 5, at 25;
€MS Ex. 28, at 124. On November 5, 2006, Patient 9 reported that he had several bowel
movements. CMS Ex. 28, at 107, 110. He also reported having a bowel movement on
November 7, 2006. CMS Ex. 28, at 104. On November 7, 2006, Petitioner’s R.N.
mentioned in a report to Patient 9’s physician that Patient 9 had been to the emergency
room for emergency disimpaction because he was uncomfortable due to severe
constipation and the Veterans Administration hospital’ had recommended that he go to
the emergency room. The R.N. did not recommend or request further orders to treat
Patient 9’s constipation. CMS Ex. 28, at 113. A L.P.N. noted on November 10 that
Patient 9 had not had a bowel movement in three days and he refused an enema. P. Ex. 5,
at 95. A report by the R.N. documenting a home visit with Patient 9 on November 15,
2006, shows he reported not having a bowel movement since November 13, 2006, but he
refused an enema. The report also indicates bowel sounds active and that if he needed an
enema later in the day his wife could do it. CMS Ex. 28, at 64-66.

Petitioner argues that Patient 9’s physician was aware and that there was nothing more
that could be done about Patient 9’s problem constipation. P. Brief, Ex. A at 35-36.
Petitioner misses the point. The requirement is that the R.N. initiate the plan of care and
any necessary revisions. The emergency room manual disimpaction on November 1,
2006, Patient 9’s refusal to have enemas administered by nursing staff, the reported
ineffectiveness of enemas administered by the wife, and repeated episodes of
constipation, all indicated that the R.N. needed to evaluate whether revision of the care
plan was necessary. However, after the emergency room procedure on November |, the
evidence reflects that the R.N. did not communicate with the physician about the event
for several days. Further, there is no evidence that the R.N. considered, with the
physician or on her own, whether different interventions might be appropriate revisions to
the plan of care. A plan of care signed by the R.N. on November 19 and the physician on
November 20, does not include new interventions for Patient 9’s constipation. CMS Ex.

7 Patient 9 received his medical care through the Veterans’ Administration
hospital. However, when he required emergency care he was seen at the regional medical
center hospital emergency room. CMS Ex. 28, at 123.
15

28, at 49-53. Further, contrary to Petitioner’s argument that nothing more could be done,
on November 24, 2006, Petitioner's R.N. and physician implemented new interventions
for Patient 9’s constipation, including changing medication and implementing a bowel
routine that required warm prune juice if Patient 9 had no bowel movement for two days,
use of milk of magnesia if no movement on the third day, enema on the fourth day if no
results, and contacting skilled nursing if the enema was ineffective. P. Ex. 5, at 77. Prior
to the new interventions on November 24, the evidence does not show that the R.N.
suggested or considered adjusting Patient 9’s plan of care subsequent to his emergency
disimpaction on November |. [ conclude that Petitioner’s R.N. failed to revise Patient 9’s
care plan as necessary, with adverse impact upon his health.

(c) Tag G174

The regulation requires that a R.N. furnish those services requiring substantial and
specialized nursing skill. 42 C.F.R. § 484.30(a). The surveyors concluded that
Petitioner’s R.N. failed to deliver services requiring substantial and specialized nursing
skills in the case of Patient 4, as discussed under Tag G172. CMS Ex. 4, at 45-49.
Patient 4 was referred for home health services because the assisted living facility where
Patient 4 lived could not provide the skilled nursing services needed for Patient 4’s knee
wound. CMS Ex. 25, at 28. Based upon the facts already discussed regarding Patient 4’s
knee wound, I find that Petitioner’s R.N. failed to deliver substantial and specialized
skilled nursing care. I find Petitioner’s arguments to the contrary to be meritless. P.
Brief, Ex. A at 9-10. The fact that the surveyor had to direct the R.N. to change the
dressing immediately, rather than the next day as the R.N. proposed, is a good example of
how the R.N. failed to provide the specialized nursing care required. [ conclude that
Petitioner violated 42 C.F.R. § 484.30(a) with adverse impact upon Patient 4’s health.

III. Conclusion
There was a condition-level violation of 42 C.F.R. § 484.30 and, therefore, a basis for

termination of Petitioner’s provider agreement and participation in Medicare effective
November 28, 2006.

/s/ Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Easley Living Center
(CCN: 42-5018),

Petitioner
Vv.

Centers for Medicare and Medicaid Services.
Docket No. C-09-87
Decision No. CR2301

Date: December 29, 2010

DECISION

Petitioner, Easley Living Center, was not in substantial compliance with program
participation requirements due to a violation of 42 C.F.R. § 483.25(c)' from August 30,
2008 through September 15, 2008. There is a basis for the imposition of an enforcement
remedy. The following enforcement remedies are reasonable: a civil money penalty
(CMP) of $3,550 per day effective August 30, 2008 through September 10, 2008; a CMP
of $100 per day effective September 11, 2008 through September 15, 2008; a denial of
payment for new admissions (DPNA) from September 14, 2008 through September 15,
2008; and withdrawal of the authority to conduct a nurse aide training and competency
evaluation program (NATCEP).

' References are to the 2007 version of the Code of Federal Regulations (C.F.R.) in
effect at the time of the survey, unless otherwise indicated.
I. Background

Petitioner, located in Easley, South Carolina, is authorized to participate in the Medicare
program as a skilled nursing facility (SNF) and in the Medicaid program as a nursing
facility (NF). Petitioner was subject to a complaint investigation and extended survey by
the South Carolina Department of Health and Environmental Control (the state agency)
on September 3, 2008. The state agency concluded, based on the findings of the
investigation and survey, that Petitioner was not in substantial compliance with program
participation requirements and that there was immediate jeopardy and substandard quality
of care. A September 22, 2008 revisit survey concluded that immediate jeopardy was
abated but that Petitioner continued not to be in substantial compliance. The Centers for
Medicare and Medicaid Services (CMS) notified Petitioner by letter dated October 30,
2008, that CMS was imposing: a CMP of $3,550 per day beginning on August 30, 2008;
a DPNA beginning on September 14, 2008; and discretionary termination of Petitioner’s
provider agreement on September 26, 2008, if the immediate jeopardy was not removed
by that date. In addition, CMS indicated in the letter that any previously granted
authority to conduct a NATCEP would be withdrawn. CMS advised Petitioner by letter
dated November 5, 2008, that the September 22, 2008 revisit survey found the immediate
jeopardy was abated, but Petitioner remained out of substantial compliance with
participation requirements. CMS advised Petitioner that: it was reducing the CMP to
$100 per day effective September 11, 2008; the DPNA remained in effect; and
discretionary termination on September 26, 2008 was changed to mandatory termination
on March 3, 2009, if Petitioner did not achieve substantial compliance prior to that date.
The state agency notified Petitioner by letter dated December 2, 2008, that a revisit
survey on October 20, 2008 concluded that Petitioner returned to substantial compliance
with participation requirements effective September 16, 2008. Joint Stipulations dated
March 4, 2009; CMS Exhibits (CMS Exs.) 1, 2, 9; Petitioner’s Exhibits (P. Exs.) 1, 2.

Petitioner requested a hearing by letter dated November 6, 2008. The case was assigned
to me for hearing and decision on November 19, 2008. On February 2, 2009, I set this
case for hearing on June 23 through 26, 2009, in Greenville, South Carolina. On June 8,
2009, the parties filed a joint, written waiver of an oral hearing and requested that I
establish a briefing schedule to develop the case for a decision on the documentary
evidence and the parties’ briefs. On June 11, 2009, I issued an order accepting the waiver
of oral hearing subject to 42 C.F.R. § 498.66(b)(1) and set a schedule for the parties to
brief the issues. CMS submitted a brief (CMS Br.) and CMS Exs. | through 13.
Petitioner submitted a brief (P. Br.) and P. Exs. 1 through 15. Petitioner filed its reply
brief (P. Reply) on August 28, 2009, and CMS waived its right to file a reply brief. No
objection has been made to my consideration of the proffered evidence and CMS Exs. |
through 13 and P. Exs. 1 through 15 are admitted as evidence.”

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

Whether there is a basis for the imposition of an enforcement
remedy; and,

Whether the remedies proposed are reasonable.
B. Applicable Law

The statutory and regulatory requirements for participation by a long-term care facility
are found at sections 1819 (SNF) and 1919 (NF) of the Act and at 42 C.F.R. Part 483.
Section 1819(h)(2) of the Act vests the Secretary of Health and Human Services
(Secretary) with authority to impose enforcement remedies against a SNF for failure to
comply substantially with the federal participation requirements that sections 1819(b),
(c), and (d) of the Act established.* Pursuant to section 1819(h)(2)(C), the Secretary may
continue Medicare payments to a SNF not longer than six months after the date the
facility is first found not in compliance with participation requirements. Pursuant to
section 1819(h)(2)(D), if a SNF does not return to compliance with participation
requirements within three months, the Secretary must deny payments for all individuals

> Petitioner argues that CMS inappropriately relies upon uncorroborated and self-serving
hearsay statements of a physician and nurse at the hospital. P. Reply at 5-6. Petitioner
does not advise me which document that CMS offered contains the objectionable hearsay
statements. Accordingly, Petitioner has waived its objection. Notice of Case Assignment
and Prehearing Case Development Order, § A.5.a (Nov. 19, 2009). Further, hearsay may
be admitted in this proceeding if it is relevant and authentic. I recognize the hearsay
nature of most all of the documentary evidence offered and admitted in this case. Iam
presumed to have the ability to determine the credibility of each piece of evidence and its
probative value, and I have carefully done so in this case.

> Section 1919(h)(2) of the Act gives similar enforcement authority to the states to
ensure that NFs comply with the participation requirements that sections 1919(b), (c), and
(d) of the Act established.
admitted to the facility after that date — commonly referred to as the mandatory or
statutory DPNA. In addition to the authority to terminate a noncompliant SNF’s
participation in Medicare, the Act grants the Secretary authority to impose other
enforcement remedies, including a discretionary DPNA, CMPs, appointment of
temporary management, and other remedies such as a directed plan of correction.
Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies
against a long-term care facility that is not complying substantially with federal
participation requirements. “Substantial compliance means a level of compliance with
the requirements of participation such that any identified deficiencies pose no greater risk
to resident health or safety than the potential for causing minimal harm.” 42 C.F.R.

§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, subpart B. State survey agencies survey facilities that
participate in Medicare on behalf of CMS to determine whether the facilities are
complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-
.335. The regulations specify the enforcement remedies that CMS may impose, if a
acility is not in substantial compliance with Medicare requirements. 42 C.F.R.

§ 488.406.

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

Petitioner was notified that the state agency could not approve Petitioner to conduct a
NATCEP and would be required to withdraw any prior approval to conduct a NATCEP
based upon the extended survey and remedies. CMS Ex. 2, at 7-8. Pursuant to sections
1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have
completed a training and competency evaluation program. Sections 1819(e) and 1919(e)
of the Act impose upon the states the requirement to specify what NATCEPs they will
approve that meet the requirements that the Secretary established and a process for
reviewing and re-approving those programs using criteria that the Secretary set. Pursuant
to sections 1819(f)(2) and 1919(f)(2), the Secretary was tasked to develop requirements
for approval of NATCEPs and the process for review of those programs. The Secretary
promulgated regulations at 42 C.F.R. Part 483, subpart D.

Pursuant to 42 C.F.R. § 483.151(b)(2) and (e)(1), a state may not approve and must
withdraw any prior approval of a NATCEP offered by a SNF or NF that has been: (1)
subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or
1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $5,000; or (3) subject to
termination of its participation agreement, a DPNA, or the appointment of temporary
management. Extended and partial extended surveys are triggered by a finding of
substandard quality of care during a standard or abbreviated standard survey and involve
evaluating additional participation requirements. “Substandard quality of care” is
identified by the situation where surveyors identify one or more deficiencies related to
participation requirements established by 42 C.F.R. § 483.13 (Resident Behavior and
Facility Practices), § 483.15 (Quality of Life), or § 483.25 (Quality of Care) that are
found to constitute either immediate jeopardy, a pattern of or widespread actual harm that
does not amount to immediate jeopardy, or a widespread potential for more than minimal
harm that does not amount to immediate jeopardy without actual harm. 42 C.F.R.

§ 488.301.

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

assigned to a noncompliance finding, except in the situation where that finding was the
basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834
(2002); Koester Pavilion, DAB No. 1750 (2000). ALJ Review of a CMP is subject to 42
C.F.R. § 488.438(e).

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

C. Analysis

My conclusions of law are set forth in bold followed by a statement of the pertinent facts
and my analysis. The surveyors allege in the statement of deficiencies (SOD) for the
survey that ended on September 3, 2009, that Petitioner violated 42 C.F.R. §§ 483.25(c)
(Tag F314, scope and severity (s/s) J, indicating isolated immediate jeopardy) and 483.75
(Tag F490, s/s yA CMS Ex. 1, at 5-13. The SOD for the revisit survey completed on
September 22, 2008, alleges the same deficiencies but at the scope and severity of D,
which means isolated instances of more than minimal harm, with no actual harm or
immediate jeopardy. The alleged violation of 42 C.F.R. § 483.75 (Tag F490) derives
from the alleged violation of 42 C.F.R. § 483.25(c) (Tag F314), and the same facts are
alleged as the basis for both deficiencies. I conclude that it is not necessary to address the
alleged violation of 42 C.F.R. § 483.75, as the deficiency cited under 42 C.F.R.

§ 483.25(c) provides a sufficient basis for the enforcement remedies imposed in this case.

I have carefully considered all the evidence and the arguments of both parties, though not
all may be specifically discussed in this decision. I discuss the credible evidence given
the greatest weight in my decision-making.* The fact that evidence is not specifically

4 An alleged violation of 42 C.F.R. § 483.10(b)(11) (Tag F157, s/s J) was deleted after
informal dispute resolution. CMS Ex. 1, at 2.

> “Credible evidence” is evidence that is worthy of belief. Blacks Law Dictionary 596
(18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Jd. at 1625.
discussed should not be considered sufficient to rebut the presumption that I considered
all the evidence and assigned such weight or probative value to the credible evidence that
I determined appropriate within my discretion as an ALJ. There is no requirement for me
to discuss the weight given every piece of evidence considered in this case, nor would it
be consistent with notions of judicial economy to do so.

1. Petitioner violated 42 C.F.R. § 483.25(c) (Tag F314).
2. There is a basis to impose an enforcement remedy.

3. Petitioner has not shown that the determination of immediate
jeopardy was clearly erroneous.

The quality of care regulation includes the requirement that a facility ensure that a
resident who enters the facility without a pressure sore does not develop one, unless
clinically unavoidable, and that a resident entering with a pressure sore receives treatment
and services necessary for healing, to prevent infection, and to prevent other sores from
leveloping. 42 C.F.R. § 483.25(c). CMS has adopted definitions for terms related to the
regulation that surveyors are to apply in conducting surveys. A “pressure sore,” often
referred to as a “pressure ulcer,” is any lesion of the skin caused by unrelieved pressure
that damages the underlying tissue. State Operations Manual, Interpretive Guidelines for
Long-Term Care Facilities, No. 100-07, appendix PP (SOM, app. PP), Tag F314.

The application of the regulation is well-established by decisions of various appellate
panels of the Board. Koester Pavilion, DAB No. 1750 and Cross Creek Health Care
Ctr., DAB No. 1665 are leading decisions in this area. The Board has noted that the
pressure sore regulation contains two prongs: (1) a facility must ensure a resident who
enters the facility without sores does not develop sores, unless the resident’s clinical
condition demonstrates that pressure sores are unavoidable; and (2) a resident with
pressure sores must receive necessary treatment and services to promote healing, prevent
infection and prevent new sores. With respect to prevention and treatment of pressure
sores, the Board has concluded that a facility bears a duty to “go beyond merely what
seems reasonable to, instead, always furnish what is necessary to prevent new sores
unless clinically unavoidable, and to treat existing ones as needed.” Koester Pavilion,
DAB No. 1750, at 32; Meadow Wood Nursing Home, DAB No. 1841 (2002) (holding
loose dressing contaminated with fecal matter constitutes violation); Ridge Terrace, DAB
No. 1834, at 15-16 (finding a single observation by a surveyor of a nurse aide cleaning an
open sore area with a stool-stained washcloth was sufficient to sustain a deficiency
finding under this Tag). Once CMS establishes a prima facie case, the facility bears the
burden of showing that the development, or deterioration, of a pressure sore was
clinically unavoidable.

In Clermont Nursing and Convalescent Ctr., DAB No. 1923, at 9-10 (2004), aff'd,
Clermont Nursing and Convalescent Ctr. v. Leavitt, 142 Fed. App’x 900 (6th Cir. 2005),
the Board provided the following analysis:

The standard of necessity is expressly articulated in the
regulation. The primary regulatory requirement is that
residents must receive, and facilities must provide, “the
necessary care and services” for attainment or maintenance of
the highest practicable resident well-being. 42 C.F.R.

§ 483.25 (emphasis supplied). The regulation then goes on to
provide that a resident with pressure sores must receive
“necessary treatment and services” for healing, prevention of
infection, and prevention of yet more pressure sores. 42
C.F.R. § 483.25(c)(2) (emphasis supplied). We therefore
reject Clermont’s contention that the standard is “nowhere in
the regulation.” That argument is belied by the plain
language of the regulation.

Moreover, as we explained in Koester Pavilion, in the
preamble to the final regulation, CMS expressly declined to
use “less demanding” language with respect to a facility’s
obligation to “ensure” outcome of treatment for pressure
sores. Koester Pavilion at 30, quoting 56 Fed. Reg. 48,826, at
48,850 (Sept. 26, 1991). CMS recognized that factors beyond
required treatment and services, such as disease process and
resident compliance, affect care outcome. Jd. However,
CMS also recognized that the regulation allows a facility to
put forward “available clinical evidence” to show that “a
negative resident care outcome was unavoidable.” Jd. The
preamble further provides that facilities “should always
furnish the necessary treatment and services” for pressure
sore prevention or healing. Jd. at 30-31 (emphasis supplied).
Thus, a facility may provide necessary treatment and services
to ensure the prevention or healing of pressure sores, yet still
be confronted with a negative outcome. In that instance, the
facility may put forward clinical evidence to show that the
outcome was unavoidable.

See also Woodland Vill. Nursing Ctr., DAB No. 2172, at 12-14 (2008).
The surveyors allege in the SOD for the September 3, 2008 survey that Petitioner

violated 42 C.F.R. § 483.25(c) based upon examples of Residents 1 and 4. The surveyors
specifically allege, based upon review of Petitioner’s records and staff interviews, that
Petitioner failed to ensure that the residents received necessary treatment and services to
promote the healing of their pressure ulcers and to prevent infections in their ulcers.
CMS Ex. 1, at 5-6. I find that the surveyor’s allegations are well-founded and I conclude
that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(c) that
Petitioner has failed to rebut.

a. Facts

Resident 1 was reported to be 78 years old when he was admitted to the Greenville
Hospital System on June 16, 2008. CMS Ex. 6, at 111; P. Ex. 9, at 4. His most recent
admission to Petitioner’s facility occurred on November 21, 2005. CMS Ex. 6, at 11.

His diagnoses included, inter alia: a history of cerebral vascular accident (CVA) with
residual left-sided facial weakness; congestive heart failure; diabetes mellitus;
ypertension; vascular dementia; peripheral vascular disease; diabetic heel ulcer; history
of partial right foot amputation; cellulitis; coronary artery disease; end stage renal disease
‘or which he was receiving hemodialysis; chronic anemia secondary to renal dialysis; and
glaucoma. CMS Ex. 6, at 11, 111, 134, 144-45; P. Ex. 6, at 1, 8.

Petitioner’s clinical records® for Resident 1 show that he developed a pressure ulcer on
his left lateral foot on August 20, 2007. The wound is described as a blister and rated as
a Stage II pressure sore’ that measured approximately four by two and one-half
centimeters with no depth, no odor, and no drainage. P. Ex. 6, at 38, 42; CMS Ex. 6, at
62, 106. As of October 11, 2007, the ulcer had worsened and was rated as a Stage III,
three by two centimeters and one centimeter deep, with some drainage but no odor. The
entry on December 27, 2007, shows that the ulcer had improved to a Stage II ulcer that
was one-half by one-half centimeter with no measurable depth, no odor, and no drainage.
The ulcer continued to be assessed as a Stage II, with increases and decreases in its
dimensions, but no odor or drainage, between December 27, 2007 and April 9, 2008.

° There are discrepancies between the residents’ wound care summary reports and their
pressure sore progress reports that are in evidence. I do not discuss the discrepancies as
Petitioner was not cited for a documentation deficiency and the existence of the
discrepancies does not affect my decision.

7 The SOM defines the four stages of pressure sores. A Stage II pressure sore is a
“[p]artial thickness skin loss involving epidermis, dermis, or both [that is]... .
superficial and presents clinically as an abrasion, blister, or shallow crater.” SOM, app.
PP, Tag F314, (citing the National Pressure Ulcer Advisory Panel (NPUAP)); CMS Ex.
6, at 185-88 (Petitioner’s policy contains definitions of ulcer stages similar to those in the
SOM).
10

On April 16, 2008, the wound had worsened. Although it continued to be staged as a
Stage II, one by one and one-half centimeters with no depth, it was reported to include
brown tissue, and there was a small amount of drainage with an odor. On May 7, 2008,
the wound had worsened and was assessed as a Stage III ulcer, two by two centimeters,
one and one-half centimeters deep, brown tissue, moderate drainage with an odor. A
physician’s note dated May 23, 2008, indicates concern about the resident’s low grade
temperature and the foul odor of the foot ulcer. CMS Ex. 6, at 134. A note dated May
30, 2008, states that Resident 1’s left heel ulcer did not look good, as: it was deeply
necrotic; dead skin, subcutaneous tissue and tendon were excised; bone was exposed; and
it could not be confirmed that he had the heel protectors previously ordered on May 16,
2008. CMS Ex. 6, at 116, 119; P. Ex. 6, at 11, 17. A bone scan of the left foot on June 9,
2008, indicated possible osteomyelitis, an infection of the bone. P. Ex. 6, at 3. On June
1, 2008, the wound was assessed as more severe at a Stage IV,* more than six by four
centimeters and three centimeters deep. The tissue was grey, and there was moderate
ischarge and an odor. P. Ex. 6, at 38-41, 42-84; CMS Ex. 6, at 62-105, 106-09.

A nurse’s note dated June 13, 2008, states that it was a late entry for June 13, 2008 at
6:00 a.m. The note states that the dressing was changed on Resident 1’s wound, which
was covered with grey slough, and that there was a moderate amount of foul smelling
rainage on the old dressing. The note states the wound was cleaned and redressed. P.
Ex. 6, at 114; CMS Ex. 6, at 43. A nurse’s notes entry, dated June 13, 2008 at 2:00 p.m.,
indicates that the family reported that Resident 1 was drifting in and out, and he seemed
to have passed out. The nurse checked and found that the resident was not responsive.
The physician was contacted, and he ordered that Resident | be sent to the emergency
room. Resident | was transported by ambulance at 2:20 p.m. P. Ex. 6, at 114; CMS Ex.
6, at 43. Petitioner admits that the 2:00 p.m. note was incorrectly dated June 13, 2008
and that it should have been dated June 15, 2008, the date Resident 1 was sent to the
hospital. Petitioner also concedes that no dressing change occurred during the morning
of June 15, 2008. P. Br. at 3-4; P. Reply at 2-4. Petitioner does not deny the erroneous
entry on its Treatment Record or Flow Sheet (P. Ex. 6, at 105; P. Ex. 1, at 9-10; CMS Ex.
1, at 9-10) that indicates a dressing change was done the morning of June 15, 2008.

A history and physical completed on June 15, 2008, at 6:52 p.m. indicates that Resident |
had an infected left diabetic foot ulcer with possible sepsis and an altered mental state
due to that problem. Resident 1’s left lower extremity was reported to be swollen with a

8 Stage IV is defined as “[f]ull thickness skin loss with extensive destruction, tissue
necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule).
Undermining and sinus tracts also may be associated with Stage IV pressure ulcers.
SOM, app. PP, Tag F314.
11

malodorous discharge from his wound and no sensation below the knee. P. Ex. 9, at 1-2,
7-8; CMS Ex. 6, at 140-41. A consultation on June 15, 2008, concluded that the resident
would most likely need an amputation, as there was no way to salvage the left lower leg
due to osteomyelitis and the necrotic ulceration. P. Ex. 9, at 11, 13; CMS Ex. 6, at 138.
On June 18, 2008, Resident 1 underwent a left above the knee amputation due to the
osteomyelitis of the left heel and the large ulcer on his foot that would not heal. CMS Ex.
6, at 114.

Resident 4, who was 69 at the time of the survey, was originally admitted to Petitioner’s
facility on April 28, 2008. CMS Ex. 7, at 69, 72. Resident 4’s diagnoses included, inter
alia, peripheral vascular disease with a history of a left below the knee amputation,
iabetes with diabetic neuropathy, coronary artery disease with a history of a coronary
artery bypass, hypertension, chronic obstructive pulmonary disease, and congestive heart
failure that was considered stable. CMS Ex. 7, at 56, 58, 60; CMS Ex. 12, at 5. Resident
4 was admitted with a Stage II ulcer on her right heel that measured four by three and
one-half centimeters with no depth measured, and it was red with a small amount of
rainage and no odor. Between April 28, 2008 and August 8, 2008, Petitioner’s clinical
records show that the resident continued to have a Stage II ulcer that varied in size and
varied in the amount of drainage from small to large amounts, but never with an odor.
On August 15, 2008, the size of the wound had increased to seven by more than five
centimeters by two tenths of a centimeter deep, with large serous drainage and an odor.
The wound was assessed as being unchanged on August 22 and 29, 2008. CMS Ex. 7, at
5-21, 89-90; P. Ex. 7, at 26-42. The heel ulcer was evaluated at the hospital, on August
30, 2008 at 3:46 p.m., as being very malodorous and down to the bone, with pus
emanating from it. CMS Ex. 12, at 6; P. Ex. 10, at 3. Resident 4 also had a smaller
vascular ulcer on her right lateral leg throughout the same period. CMS Ex. 7, at 23-32,
91-92; P. Ex. 7, at 15-16, 18-25. The ulcer on the right leg was also assessed at the
hospital on August 30, 2008, as being malodorous with visible pus. CMS Ex. 12, at 6-7;
P. Ex. 10, at 3.

On August 30, 2008, Resident 4 was confused with low blood oxygen saturation. She
was sent to the emergency room at 9:15 a.m. on August 30, and she was admitted to the
hospital at 2:00 p.m. CMS Ex. 7, at 55; P. Ex. 7, at 2-4. A final Surgical Routine report,
dated September 2, 2008, contains the examination of Resident 4’s leg and foot and
reflects gangrene with both necrotic tissue and bone visualized. P. Ex. 7, at 131-32. A
discharge summary, dated September 3, 2008, shows that Resident 4’s discharge
diagnoses were a urinary tract infection, a necrotic and possibly infected right foot,
diabetes mellitus, and that she underwent a right above the knee amputation on August
31, 2008. CMS Ex. 12, at 3-4; P. Ex. 7, at 134-35; P. Ex. 10.

12

b. Analysis

I have no difficulty concluding that CMS has made a prima facie showing of a violation
of 42 C.F.R. § 483.25(c), with more than minimal harm to both Residents 1 and 4, based
upon the undisputed evidence from Petitioner’s clinical records. Resident 1 developed a
pressure sore while at Petitioner’s facility, and the sore worsened. Resident 4 was
admitted with a pressure ulcer and the ulcer worsened. Above the knee amputations were
performed in each case. The evidence shows that Resident 1 was admitted to Petitioner
on November 21, 2005. On August 20, 2007, he developed a Stage II pressure sore on
his left lateral foot. By October 11, 2007, the ulcer had worsened to a Stage III ulcer with
drainage and odor. The ulcer had improved to a Stage II ulcer by December 27, 2007,
evidence that the ulcer could heal. The ulcer was worse on April 16, 2008. It was
evaluated as a Stage III ulcer on May 7, 2008, with drainage and odor. The ulcer was
characterized as deeply necrotic with exposed bone on May 30, 2008. On June 11, 2008,
the ulcer was assessed as Stage IV. On June 18, 2008, Resident 1’s left leg was
amputated above the knee. The evidence shows that Resident 4 was admitted to
Petitioner’s facility on April 28, 2008, with a Stage II ulcer on her right heel. The
evidence shows that the ulcer was stable until August 15, 2008, when the size of the
wound was increased, and there was drainage and an odor. On August 31, 2008,
Resident 4’s right leg was amputated above the knee because of gangrene and necrotic
bone associated with the ulcer. These facts are not disputed.

CMS has made a prima facie showing of a deficiency under 42 C.F.R. § 483.25(c) (Tag
F314) and that the deficiency constituted more than minimal harm to Petitioner’s
residents. Accordingly, the burden of persuasion is upon Petitioner to show by a
preponderance of the evidence that it was in substantial compliance or that it had an
affirmative defense, such as unavoidability. As already discussed, the Board has
recognized that a facility may provide necessary treatment and services to ensure the
prevention or healing of pressure sores, yet still be confronted with a negative outcome,
in which case the facility may put forward clinical evidence to show that the outcome
was unavoidable. Clermont Nursing and Convalescent Ctr., DAB No. 1923, at 9-10.
Petitioner fails to satisfy its burden in this case.

Petitioner argues that the CMS prima facie case relies upon the fact that maggots were
found in the wounds of both Resident 1 and Resident 4 “several hours” after they were
admitted to the hospital. P. Br. at 6. Petitioner argues that because CMS fails to identify
any specific acts or omissions on the part of Petitioner the CMS case must fail.
Petitioner’s theory is that the presence of maggots is not conclusive evidence of
wrongdoing by Petitioner because there are possible sources for the maggots other than
Petitioner’s facility. Petitioner asserts that CMS is attempting to impose strict liability
upon Petitioner, and the Board has previously found strict liability should not be applied
in these cases. P. Br. at 7. Petitioner’s arguments are wrong in several respects. The
CMS case is not based only upon the presence of maggots in the ulcers of the residents.
13

The worsening of the ulcers in each resident that Petitioner’s clinical records reflect, the
admitted documentation errors by Petitioner’s staff, the fact that Resident 1’s dressing
was not changed on June 15, 2008 before he went to the hospital, and the maggots in the
wound are each pieces of evidence that support the government’s prima facie showing.
The evidence cited in the SOD” and admitted as evidence by CMS is sufficient for a
prima facie showing of the deficiency, even without consideration of the maggots
discovered at the hospital. Further, CMS does not argue that Petitioner is strictly liable,
and I do not apply a strict liability standard. Rather, Petitioner is granted the opportunity
to present its defenses.

Petitioner argues regarding Resident | that: the pressure sore on his left foot was
unavoidable; Petitioner took all appropriate steps to heal the ulcer and prevent infection;
and wound changes reflected in the clinical record are consistent with appropriate
treatment. Petitioner relies upon the affidavit of Toni Silver, who has a Master of
Science in Nursing, is a board certified Advanced Practice Registered Nurse, and is a
Certified Wound Care Specialist. P. Br. at 2-3 (citing P. Ex. 14). Nurse Silver is not a
physician, and her affidavit does not reflect the special expertise or experience necessary
for her to opine credibly upon whether or not the development and worsening of pressure
ulcers is unavoidable. Her affidavit also fails to show how much experience she actually
has in wound care. I do accept her degree and certifications as evidence that she has
knowledge of wound care and is qualified to render opinions regarding appropriate
wound care and the prevention of infection. However, both her affidavit and the clinical
record show that Nurse Silver provided wound care for Residents | and 4, and it is not
surprising that Nurse Silver would opine that her treatment of the residents was
appropriate. Nurse Silver opines that, due to Resident 1’s significant circulatory
impairment, the ulcer on the left lateral foot was unavoidable. I do not find that Nurse
Silver has the credentials to render a credible or weighty opinion in this regard. Even if I
found Nurse Silver had sufficient experience to render an opinion regarding the
unavoidability of the development or worsening of a pressure sore, her opinion here is
unsupported by any citation to, or evaluation of, the clinical evidence to show how
severely the resident’s circulation was actually impaired, or the interventions that were
implemented to address the impaired circulation to avoid the development of an ulcer or
its worsening. Her opinion is also inconsistent with the evidence that Resident 1’s ulcer
actually improved for a time, reflecting that his circulation was not so impaired as to
prevent improvement.

° Additional factual findings in the SOD support the surveyor’s conclusion that a
deficiency existed. However, I find that discussion of those additional facts is not
necessary to conclude that there was a prima facie showing by CMS. CMS Ex. 1, at 5-
11.
14

Petitioner argues that the surveyor identified no failure or omission by Petitioner related
to Resident 1, other than the documentation error and the failure to change the dressing
on June 15, 2008. P. Br. at 4. Petitioner’s argument shows that Petitioner
misunderstands its burden. CMS has made a prima facie showing of a deficiency under
42 C.F.R. § 483.25(c), based on the worsening of Resident 1’s ulcer and the related
infection. Petitioner thus has the burden to show it did all that was necessary to prevent
and heal the resident’s ulcer. Petitioner does not meet its burden. Petitioner elected to
waive an oral hearing and present its defense based upon its clinical records and a few
affidavits. However, Petitioner admits before me that its clinical records are in error, and
that casts doubt upon the credibility of the remainder of Petitioner’s clinical records.
Petitioner argues that its records show that it performed all tasks related to the care and
treatment of Resident 1’s pressure sore appropriately. P. Br. at 4-5; P. Reply at 3-4. I
cannot agree with that conclusion, based upon the affidavit of Nurse Silver or the
admittedly erroneous clinical records. Even if I agreed with Petitioner that its records
show that Petitioner executed all tasks appropriately in the case of Resident 1, that does
not satisfy Petitioner’s burden to show that it did all that was necessary.

Regarding Resident 4, Petitioner asserts that staff appropriately treated the pressure ulcer
on her right heel to promote healing and prevent infection. Petitioner asserts that changes
in size and appearance were consistent with appropriate treatment. Petitioner cites the
affidavit of Nurse Silver in support of its assertions. Nurse Silver states that Resident 4
had compromised circulation of the lower extremities. Although not specifically stated,
as I read her affidavit, Nurse Silver’s opinion is that the development and worsening of
Resident 4’s heel ulcer was unavoidable. I do not find that opinion credible or weighty,
for the same reasons discussed above regarding her opinions related to Resident 1. Nurse
Silver states that the changes in the resident’s wound reflected in the clinical record may
be consistent with appropriate treatment. I accept, based upon her training, that Nurse
Silver may be correct that changes in the resident’s ulcer reflected in the clinical record at
any given time, including increased size of the ulcer or the presence of odor or drainage,
may be consistent with, or at least not inconsistent with, appropriate treatment. However,
Nurse Silver does not testify or even suggest that the state of the resident’s ulcer when it
was first seen in the emergency room on August 30, 2008, is consistent with an
appropriately treated pressure ulcer.

Petitioner asserts that the only wrongdoing identified in the SOD regarding its treatment
of Resident 4 was a documentation error that involved staff documenting treatment for
Resident 4 the day after she went to the hospital and was not present in the facility. P. Br.
at 6 (citing P. Ex. 1, at 11). Petitioner argues that the surveyors cited no other
wrongdoing related to Resident 4. Petitioner also argues that it performed all tasks
related to Resident 4’s care and treatment appropriately. P. Br. at 6. Neither argument is
persuasive for the same reasons they were not persuasive in the case of Resident 1.
15

Nurse Silver also opines that the signs and symptoms displayed by each of the residents
when they were sent to the emergency room were completely unrelated to their pressure
ulcers. I find that opinion is not credible or weighty. Nurse Silver does not have the
qualifications to credibly opine as to whether symptoms, such as those displayed by the
residents, may have been caused by gangrenous (dead or necrotic) tissue or bone or
infection associated with the ulcer or the bone. I conclude that Nurse Silver’s opinions
expressed in her affidavit are insufficiently credible or weighty to meet Petitioner’s
burden of persuasion.

Petitioner also relies upon the affidavit of Christopher J. Patterson, M.D., a Certified
Medical Director, who has been Petitioner’s Medical Director since 1999. P. Br. at 8, 12;
P. Ex. 15. Dr. Patterson attests that he reviewed the medical records for Resident | and
Resident 4. Based upon his review of the records, Dr. Patterson opined that both
residents suffered from vascular impairments that made development of pressure ulcers
clinically unavoidable. He further opined that Petitioner did not do, or fail to do,
anything that caused either resident to develop pressure ulcers or that caused their ulcers
to deteriorate. He opined that the wound care provided the residents was appropriate and
that nothing in the records indicates that the care provided by the facility caused, or was
likely to cause, serious injury, harm, impairment, or death. He opined that the facility
was not the source of the maggots in the residents’ wounds.

As a medical doctor, Dr. Patterson is certainly qualified to render medical opinions. He
does not attest that he was the treating physician for either resident or that he examined
either resident. I do not give significant weight to his conclusory opinion that the
residents’ vascular impairments were so significant as to make the development of ulcers
unavoidable. Dr. Patterson cites to no specific evidence upon which his opinion is based,
related to studies of the residents’ circulatory systems or the opinions of qualified
physicians who actually examined the residents and assessed their circulation. Dr.
Patterson’s opinion is also inconsistent with the fact that Resident 1’s ulcer improved for
a time and that Resident 4’s ulcer remained stable for roughly four months prior to its
significant worsening. I also do not consider weighty Dr. Patterson’s opinion that
Petitioner did not do, or fail to do, anything that caused either resident to develop
pressure ulcers or that caused the worsening of their ulcers. Dr. Patterson does not attest
that he evaluated alternative interventions that were not implemented, or not fully
implemented, that may have helped prevent ulcers or their exacerbation. Thus, Dr.
Patterson did not assess whether or not Petitioner did all that was necessary to prevent or
heal ulcers. I also do not find weighty Dr. Patterson’s opinion that no care provided
caused, or was likely to cause, serious injury, harm, impairment, or death, i.e., immediate
jeopardy. There is no dispute that the deterioration of the ulcers for both residents
16

necessitated above the knee amputations for both residents. Regarding his opinion that
Petitioner was not the source of the maggots, whether or not Petitioner was the source of
maggots in the residents’ wounds does not impact my conclusion that CMS made a prima
facie showing or my conclusion that Petitioner has failed to rebut the prima facie case. It
also does not establish an affirmative defense.

I conclude that Petitioner also failed to show that the CMS determination that there was
immediate jeopardy was clearly erroneous. The CMS determination about the level of
noncompliance must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c). The
CMS determination that there was immediate jeopardy is presumed correct, and the
facility has a heavy burden to overturn it. Stone County Nursing & Rehab. Ctr., DAB
No. 2276, at 17 (2009); Edgemont Healthcare, DAB No. 2202, at 20 (2008); Daughters
of Miriam Ctr., DAB No. 2067, at 7 (2007). Petitioner was not in substantial compliance,
because it did not show that it provided necessary care and services for Residents 1 and 4
to prevent worsening of their ulcers, to prevent infections, and to promote healing. The
evidence shows that the residents’ pressure sores deteriorated to such a degree that they
both needed above the knee amputations. The worsening of the residents’ ulcers and the
amputations they suffered are clearly serious harm, and the gangrene and infections they
suffered posed a serious threat such that the residents could have died. Based upon the
evidence in this case, CMS’s determination is not clearly erroneous.

4. The remedies proposed are reasonable.

I have concluded that Petitioner violated 42 C.F.R. § 483.25(c) and that the violation
posed immediate jeopardy to one or more facility residents. Ifa facility is not in
substantial compliance with program requirements, CMS has the authority to impose one
or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.
The regulations specify that a CMP that is imposed against a facility on a per day basis
will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper
range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose
immediate jeopardy to a facility’s residents and, in some circumstances, for repeated
deficiencies. 42 C.F.R. §§ 488.438(a)(1)(i), (d)(2). “Immediate jeopardy means a
situation in which the provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm, impairment, or death
to a resident.” 42 C.F.R. § 488.301 (emphasis in original). The lower range of a CMP,
$50 per day to $3,000 per day, is reserved for deficiencies that do not constitute
immediate jeopardy but either cause actual harm to residents, or cause no actual harm but
have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).

If I conclude, as I have in this case, that there is a basis for the imposition of an
enforcement remedy and the remedy proposed is a CMP, my authority to review the
reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e). The limitations are: (1)
I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of
17

discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors
specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP
amount. In determining whether the amount of a CMP is reasonable, the following
factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility’s history
of non-compliance, including repeated deficiencies; (2) the facility’s financial condition;
(3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same
factors CMS and/or the state were to consider when setting the CMP amount; and (4) the
facility’s degree of culpability, including, but not limited to, the facility’s neglect,
indifference, or disregard for resident care, comfort, and safety. The absence of
culpability is not a mitigating factor.

The factors that CMS and the state were required to consider when setting the CMP
amount and that I am required to consider when assessing the reasonableness of the
amount are set forth in 42 C.F.R. § 488.404(b): (1) whether the deficiencies caused no
actual harm but had the potential for minimal harm, no actual harm with the potential for
more than minimal harm, but not immediate jeopardy, actual harm that is not immediate
jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the
deficiencies are isolated, constitute a pattern, or are widespread. My review of the
reasonableness of the CMP is de novo and based upon the evidence in the record before
me. I am not bound to defer to the CMS determination of the reasonable amount of the
CMP to impose, but my authority is limited by regulation as already explained. I am to
determine whether the amount of any CMP proposed is within reasonable bounds,
considering the purpose of the Act and regulations. Emerald Oaks, DAB No. 1800, at 10
(2001); CarePlex of Silver Spring, DAB No. 1683, at 14-17 (1999); Capitol Hill Cmty.
Rehab. and Specialty Care Ctr., DAB No. 1629 (1997).

CMS proposed the following remedies: a CMP of $3,550 per day effective August 30,
2008 through September 10, 2008, the period of immediate jeopardy; a CMP of $100 per
day effective September 11, 2008 through September 15, 2008; a DPNA from September
14, 2008 through September 15, 2008; and withdrawal of the authority to conduct a
NATCEP. Petitioner asserts that the imposition of a CMP is erroneous or unreasonable.
P. Br. at 14; P. Reply at 7. Petitioner does not specifically state why the CMP is
unreasonable or dispute the date CMS determined that Petitioner returned to substantial
compliance, except to the extent that Petitioner’s position is that it remained in substantial
compliance.

I have concluded that Petitioner was not in substantial compliance from August 30, 2008
through September 10, 2008, and that the noncompliance posed immediate jeopardy.
Thus, a CMP in the upper range of $3,050 to $10,000 per day is authorized for each day
of immediate jeopardy. 42 C.F.R. § 488.438(a)(1)(i). I have received no evidence
regarding Petitioner’s financial condition or a history of noncompliance. I conclude
based on the evidence of record that Petitioner’s noncompliance was extremely serious
and resulted in serious harm to both residents. I further conclude that Petitioner was
18

culpable in its failure to deliver necessary care and services to prevent the significant
deterioration of the residents’ ulcers. The $3,550 per day CMP that CMS proposed is at
the low end of the upper range, and it is not unreasonable. I also conclude that the $100
per day CMP effective September 11, 2008 through September 15, 2008, is not
unreasonable given the seriousness of the deficiency after immediate jeopardy was
abated, the culpability of the facility, and the fact that the per day CMP is at the low end
of the lower range of authorized CMPs. 42 C.F.R. § 488.438(a)(1)(ii).

CMS had authority to impose the discretionary DPNA because Petitioner was not in
substantial compliance, and I have no authority to review the choice of that remedy. 42
C.F.R. § 498.3(b)(14); 42 C.F.R. §§ 488.406, 488.408(g)(2). Petitioner’s loss of
authority to conduct a NATCEP and its ineligibility to be approved to conduct a
NATCEP for two years following the survey are required by law due to the facts that an
extended survey was conducted, a DPNA was imposed, and the CMP was $5,000 or
more. Act § 1819(f)(2)(B).

II. Conclusion

For the forgoing reasons, I conclude that Petitioner was not in substantial compliance
with program participation requirements from August 30, 2008 through September 15,
2008. I further conclude that the following enforcement remedies are reasonable: a
CMP of $3,550 per day effective August 30, 2008 through September 10, 2008, the
period of immediate jeopardy; a CMP of $100 per day effective September 11, 2008
through September 15, 2008; a DPNA from September 14, 2008 through September 15,
2008; and withdrawal of the authority to conduct a NATCEP.

/s/
Keith W. Sickendick
Administrative Law Judge