Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Manor Care of Largo, Inc., |
DATE: February 23, 2001 |
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Health Care Financing Administration
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Docket No.C-00-127
Decision No. CR746 |
DECISION | |
I decide that Manor Care of Largo, Inc. (Petitioner)
was not in substantial compliance with Medicare participation requirements
at the time of the February, June, and August 1999 surveys. Further, I find
that the Health Care Financing Administration's (HCFA) failure to provide
Petitioner with a Statement of Deficiencies within 10 days of the completion
of each of the aforementioned surveys does not invalidate the survey findings
or the termination and I have no authority to grant Petitioner any relief.
Finally, I decide that HCFA was authorized to terminate Petitioner's Medicare
provider agreement. I. Applicable law Medicare, a federally subsidized health insurance program for the elderly and disabled, was established under Title XVIII of the Social Security Act (Act). Medicare provides reimbursement for certain services rendered by providers, such as a skilled nursing facility (SNF) like Petitioner, who participate in the Medicare program under "provider agreements" with the United States Department of Health and Human Services (DHHS). In order to enter into such an agreement, SNFs must meet certain requirements imposed by applicable statute and regulations. Section 1819 of the Act [42 U.S.C. � 1395i - 3]; 42 C.F.R. Parts 483, 488, and 489. The requirements for participation in Medicare by SNFs are set forth at 42 C.F.R. Part 483. A SNF is subject to the survey, certification, and remedies provisions of 42 C.F.R. Part 488, and to the provisions governing provider agreements at 42 C.F.R. Part 489.
4. Petitioner was not in substantial compliance with Medicare participation requirements at the time of the August 1999 survey. Section C of Discussion below.
V. Discussion
Following the February 1999 survey, HCFA cited Petitioner
with a deficiency, specifically the subsection of the regulations concerning
Quality of Care - Pressure Sores, 42 C.F.R. � 483.25(c), which requires
that with respect to pressure sores:
42 C.F.R. � 483.25(i)(1). To support the allegations that the provider failed to comply with these requirements, the situation of Resident 1 is detailed at F Tag 314, and the situations of Residents 1, 2, and 3 are detailed at F Tag 325 on the HCFA 2567. HCFA Ex. F-3 at 7. The specific allegations are that Petitioner failed to provide the necessary treatment for the avoidance of pressure sores in Resident 1, and Petitioner failed to adequately monitor in a timely manner the weights of three residents who experienced unplanned weight loss. Id. at 2, 5.
Resident 1 Resident 1 was a 93-year-old female, who had diagnoses
of senile dementia, hypertension (HTN), congestive heart failure (CHF),
sick sinus syndrome, status post pacemaker, leg edema secondary to venous
insufficiency and congestive heart failure, osteoporosis, arteriosclerotic
cardiovascular disease (ASCVD), a history of cellulitis in the left hand
and glaucoma. P. Ex. 2 at 1; HCFA Ex. F-5 at 7. Prior to her transfer to Petitioner's facility, Resident
1 was a resident at a facility in Greenbelt, Maryland, from November 26,
1997 through January 12, 1999. HCFA Ex. 11 at 8; P. Ex. 2 at 1. On January
13, 1999, Resident 1 was transferred to Petitioner's facility. Id.
The diagnosis of Resident 1's medical condition was the same in both facilities.
HCFA Ex. 11 at 8; HCFA Ex. F-5 at 7. According to the resident's medical
file, at the time of her admission to Petitioner's facility, there were
no indications of pressure sores or open skin areas. Id. at 10,
41; Tr. at 732. HCFA alleges that Petitioner could have avoided the development
of pressure sores by providing timely preventative care and that the lack
of timely care resulted in the development of pressure sores. This condition
ultimately resulted in the hospitalization of the resident for surgical
debridement of a Stage IV decubitus ulcer. HCFA Br. at 9. In response to the allegations, Petitioner argues that
the HCFA 2567 fails to specify what portions of the participation requirement
were not met. They further argue that the standard encompassed by F Tag
314, which dictates that "a facility is deficient under the regulations
if a resident develops a pressure sore within 23 days of admission" is
an inaccurate standard. P. Br. at 31. Petitioner goes on to assert that
42 C.F.R. � 483.25(c) requires HCFA to prove how and why a pressure sore
is avoidable based upon the resident's clinical status, and therefore,
based upon this standard, a deficiency occurs only in the presence of
such evidence. Id. at 6. I do not agree with Petitioner's interpretation of the
applicable standard. It has previously been determined that where a resident
is admitted into a facility without pressure sores and such sores develop
while the resident is in the care of the facility, the burden is on the
provider to "prove by a preponderance of the evidence [that it is more
likely than not] that the resident's clinical condition made the pressure
sores unavoidable." Koester Pavilion, DAB CR650 (2000), aff'd,
DAB No. 1750 (2000). For the sake of clarity, HCFA erred in its assessment
that, prior to Resident 1's admission to Petitioner's facility, she had
no pressure sores. HCFA Br. at 11. To be accurate, the record reflects
that Resident 1 had, in fact, had skin tears while a resident at the Greenbelt
facility. HCFA Ex. F-5 at 3, 4. However, at the time of her transfer to
Petitioner's facility, those pressure sores were non-existent. Id.
at 41. With this information contained in her record, it was Petitioner's
obligation to take preventative measures to ensure that new pressure sores
would not develop. Preventative measures would include, among other things,
rotation and repositioning of an immobile resident. Based upon the evidence and testimony presented at hearing,
I am not convinced by Petitioner's contention that Resident 1's pressure
sores were the result of her clinical condition, thereby making their
development unavoidable. On January 13, 1999, a treatment order was entered
directing the nursing staff to, among other things, "turn and rotate Q2;
document each shift." HCFA Ex. F-5 at 11. Terry Lawrence, Director of
Nursing during the relevant period, testified that notations in the nurse's
notes reflecting rotation and repositioning would be indicated by the
notation "q. shift." Tr. at 741, 812. The order for turning and repositioning
of residents every two hours is in accordance with the Clinical Practice
Guidelines. HCFA Ex. O-13 at 13. There is no evidence in the record which would indicate
that the treatment orders regarding repositioning of the resident were
implemented prior to January 19, 1999. A nurse's note on the resident's
day of admission indicates that Resident 1 "picks at diaper." HCFA Ex.
F-5 at 41. Another notation on January 14th reads "Pt noted
to have picked her diaper apart." Id. at 42. These would be common
sense indications of some type of irritation in the diaper area. A subsequent
nurse's note indicates that the resident, while sitting in her wheel chair,
repeatedly slid from an upright position. Id. at 43. The note further
states that the resident's niece, who was visiting that particular day
and witnessed the incident, suggested that a wedge be placed in the wheelchair
to hold the resident upright. Id. The first notation of any "q
shift" is dated January 19, 1999. Id. at 44. So, according to the
nurse's notes, the routine rotation procedure was not implemented until
five days after Resident 1's admission. On January 22nd, scratches
to the resident's right hip in the sacral area was noted. Id. at
45. It is at this time that a second "q shift" is noted for itching and
diaper rash, and a treatment ointment was ordered and applied. Id.
Two days later, on January 24th, an open sacral area on the
resident's right hip is noted. Id. at 46. A nurse's note is entered
instructing a position change every two hours to prevent further skin
breakdown. Id. Petitioner argues, and I agree, that Resident 1 received
nutritional and mineral supplements beyond those ordinarily administered.
The record is resplendent with such documentation. Tr. at 327, 339-40;
HCFA Ex. F-5 at 6, 11. It is evident that Petitioner took reasonable measures
to ensure the sufficiency of Resident 1's nutritional levels. However,
the same cannot be said for the other preventative measures Petitioner
failed to initiate. It is apparent from the evidence that Petitioner failed
to implement the rotation order in a timely and effective manner. Petitioner
asserts that the testimony of the surveyor, Joyce Battle, concedes that
the resident was in fact rotated every two hours. P. Br. at 34-35. The
line of questioning on this issue was as follows:
Tr. at 322. This line of questioning is somewhat misleading. "Exhibit
2, page 21," which was referenced in the testimony, refers to Petitioner's
Exhibit 2 at page 21. This is the medication/treatment order dated January
13, 1999, the date of Resident 1's admission to Petitioner facility. That
document merely shows that the order was made for the resident to be repositioned
every 2 hours. This document does not validate the conclusion that these
measures were in fact implemented. The next document relied upon by Petitioner
to support the assertion that Petitioner followed the reposition orders
is Petitioner's treatment record. See P. Ex. 2 at 66. Based upon
the notations in the treatment record, it was conceded and concluded that
Petitioner followed preventative measures as to the pressure sores. What
was omitted from the testimony was that this treatment record is reflective
only for the month of February. There is nothing in the records which
purports to be a treatment record for the month of January. In fact, as
previously discussed, there is nothing in any document which shows the
reposition and rotation being implemented prior to January 19th.
By this time, notations relating to the resident's apparent discomfort
from the diapers had been noted. Within 48 hours of the first rotation
note, scratches in Resident 1's right hip sacral area had been noted. Petitioner did not take sufficient preventative measures
to ensure that Resident 1 did not develop pressure sores. According to
the record, there was a six-day lag time between the resident's admission
and the implementation of the rotation process. This lag-time was strictly
contrary to the orders of the attending physician dated January 13, 1999.
Petitioner has not met its burden of proving by a preponderance of the
evidence that it was in substantial compliance with the requirements of
42 C.F.R. � 483.25(c) insofar as Resident 1 is concerned.
With regard to F Tag 325, Petitioner asserts that the
surveyor identified three of the oldest, sickest residents in the facility
for review, and without consideration of their clinical conditions, cited
Petitioner for unintended weight loss. P. Br. at 37.
Resident 1 The surveyor alleged that the facility failed to follow
its own policy for weight loss, which provided that a resident should
be re-weighed immediately in the event of a change in weight. HCFA Ex.
F-3 at 5. HCFA asserted that Petitioner's failure to stringently
monitor Resident 1's weight loss contributed to the development of the
pressure sores discussed at F Tag 314. See Section A(1) of Discussion
above; HCFA Ex. F-3 at 5-6. Petitioner contests HCFA's attempt to argue, at the hearing,
alternative bases for this deficiency citation which were not alleged
in the HCFA 2567. P. Br. at 39. Petitioner argues that the deficiency
cited was for its failure to follow the facility's internal policy regarding
weight monitoring. Petitioner avers that the evidence presented at the
hearing was to prove that Resident 1's weight loss was due to circumstances
other than the lack of consistent monitoring (i.e., the administration
of Lasix and not being sufficiently fed). Id. at 39, 40. On this point, I agree with Petitioner's argument. I find
that the only question at issue is whether, by failure to implement their
own internal policy with respect to weight monitoring, Petitioner failed
to maintain acceptable parameters for, among other things, body weight. HCFA makes some valid assertions with regard to the standard
of care Petitioner should have utilized with regard to monitoring the
weight of Resident 1. Knowing that the resident had difficulty maintaining
her weight (HCFA Ex. F-5 at 1), and having assessed through their own
examination that the resident had poor oral intake (Id. at 7),
Petitioner should have weighed Resident 1 more than just the three times
that it actually did. Unfortunately, HCFA has not cited to any rule or
regulation which dictates that failure of a facility to comply with internal
policy and procedure is basis for a deficiency citation under F Tag 325. An analogous case, Lake City Extended Care Center, DAB CR494 (1997), addresses this point. This case involved deficiency citations for, among other things, failure to adequately monitor and report changes or variations in a resident's temperature. The ALJ determined that:
DAB CR494 at 16. I agree with Petitioner's assertion that the regulations
do not require a facility to weigh residents at specific intervals. Petitioner's
internal policy mandated that residents would be weighed once a month
on the same day. HCFA Ex. F-4 at 4. The policy further stipulates that
in the event of a noted weight change (gain or loss), the resident will
be reweighed immediately and only the reweight documented. Id.
The Vital Statistic Flow Sheet shows that Resident 1 weighed in on January
13th at 92 pounds; then on February 10th at 74.75
pounds, and on February 18th at 83.3 pounds. P. Ex. 2 at 32.
Based upon the record, it is apparent that Petitioner did follow its policy
with regard to the schedule for weight monitoring. However, it fell short
in the reweight process. An 18 pound weight loss should have been visually
obvious. Therefore, Petitioner should have reweighed Resident 1 prior
to February 10th. As previously stated, this failure to adhere
to internal policy is not, in itself, a failure to comply with federal
participation requirements. In the language of the regulation, it must
be shown that, due to a resident's clinical condition, the maintenance
of her weight is not possible. In this instance, the facts demonstrate
that, even in spite of an 18 pound weight loss, Resident 1 was able to
gain 9 pounds in 8 days. P. Ex. 2 at 32. On February 10th and
again on February 15th, the dietician revised Resident 1's nutritional
regimen presumably in response to the changes in the resident's physical
condition. P. Ex. 2 at 44-45, 46. Apparently, the revision of Resident
1's nutritional regimen added in the resulting weight gain. The basis for the surveyor's deficiency citation on the
HCFA 2567 was that Petitioner failed to comply with its internal policy
regarding resident weight management. Had the surveyor determined that
the cite was predicated on Petitioner's failure to monitor and maintain
the resident's weight, then I would find that Petitioner was not in substantial
compliance in this particular instance. However, this was not the basis
for the deficiency under F Tag 325. Therefore, based on the arguments
and evidence advanced, I find that Petitioner was in substantial compliance
with the federal participation requirements of 42 C.F.R. � 483.25(i)(1)
as it pertains to Resident 1.
Residents 2 and 3 Like Resident 1 discussed in detail above, Residents 2
and 3 experienced unplanned weight loss while in the care of Petitioner's
facility. Petitioner was cited with a violation of F Tag 325 with regard
to these two residents as well as Resident 1. HCFA Ex. F-3 at 6-7. Both
parties assert the same arguments presented for Resident 1. In addition,
Petitioner contends that HCFA presented no evidence at the hearing to
support their allegations with regard to Residents 2 and 3. P. Br. at
41, 42. It should also be noted that HCFA failed to even argue the F Tag
325 citation or the rationale behind the citation in its post-hearing
brief. Therefore, for the reasons set forth as to Resident 1,
I find that Petitioner was in substantial compliance with the requirements
of 42 C.F.R. � 483.25(i)(1) as it pertains to Residents 2 and 3.
Following the June 1999 survey, HCFA cited Petitioner with one deficiency, specifically the section of the regulations concerning Quality of Care, 42 C.F.R. � 483.25, which states:
42 C.F.R. � 483.25; HCFA Ex. 15. To support the allegation that the provider failed to
comply with this requirement, the situation of Resident 19 is detailed
at F Tag 309 on the HCFA 2567. HCFA Ex. J-2 at 3-8. The preponderance
of the evidence shows that Petitioner failed to provide the care and services
necessary to treat/circumvent Resident 19's dehydrated state, thereby
manifesting Petitioner's noncompliance with participation requirements
in respect to F Tag 309.
Resident 19 From March 4, 1999 through May 6, 1999, Resident 19, a
95-year-old female, was hospitalized for extensive surgical treatment
of a large infected sacral decubitus ulcer. HCFA Ex. J-8 at 13, 16. On
May 6, 1999, Resident 19 was transferred to Petitioner. Id. at
16. At the time of the resident's transfer to Petitioner's facility, the
sacral decubitus ulcer was determined to be healed. Id. at 17.
Resident 19 resided at Petitioner's facility from May 6, 1999 to May 19,
1999. At the time of admission to Petitioner's facility, the nurse's assessment
report indicated, among other things, that Resident 19 weighed 132 lbs.,
was alert, unable to speak, regular respiratory functions, showed no signs
of edema, skin turgor was good, and the report did not make any notations
regarding the presence of pressure sores. Id. at 26-27. See
also, id. at 32. Petitioner's Plan of Care notes that, among
other medications, 40 mg of Lasix was prescribed, and the resident's diet
would consist of a pureed diet with Ensure supplements. Id. at
24. Lasix, a diuretic, is a drug which is prescribed for the treatment
of high blood pressure. A diuretic, when administered, will reduce the
fluid volume in a patient. Tr. at 121. When a diuretic is administered
to a patient who is experiencing dehydration, that patient will become
more dehydrated. Id. When dehydration occurs in elderly patients,
there is an increased risk of skin breakdown and low blood pressure which,
in extreme cases, may cause a patient to go into shock and eventually
death. Id. at 121-122. Laboratory findings which are indicative
of dehydration are tests of the blood uria nitrogen (BUN) and the creatinine.
Id. at 118. The numeric range for a normal BUN level is between
8 and 28. Anything finding over 28 is a clear indicator of dehydration.
However, in rare instances, a low reading of 8 can indicate dehydration
as well. Id. at 121. At the time of admission, a Nursing Physical
Assessment report was conducted for Resident 19. In that assessment, the
attending nurse noted that Resident 19 had a clear urine output and that
she had moist mucous membranes, both indicators of good hydration. Tr.
at 124; HCFA Ex. J-8 at 26-27. Additionally, the nursing notes for May
6, 1999 indicated that Resident 19's blood pressure was 118 over 66. HCFA
Ex. J-8 at 32. A laboratory work-up of the resident's body chemistry was
ordered and conducted on May 10, 1999, which was four days after her admission
to Petitioner facility. The results of the lab tests indicated that, since
admission, Resident 19's BUN level increased to 50 and her creatinine
level was 1.4. Tr. at 126; HCFA Ex. J-7 at 12. Petitioner contends that the surveyor's reason for the
deficiency cite was inappropriate. Specifically, Petitioner argues that
they were cited with the Quality of Care deficiency because an accurate
assessment evaluation had not been assembled nor had a plan of care been
implemented by Petitioner, which resulted in their inability to meet the
needs of Resident 19. P. Br. at 44. In fact, Petitioner does not dispute
the essence of the deficiency, i.e., that Resident 19 suffered from dehydration
and that dehydration was avoidable. Petitioner asserts that:
Id. at 44-45. First, I disagree with the assertion that Petitioner was
cited for this deficiency solely because of its failure to have a completed
assessment evaluation or to have a plan of care in place. Based upon the
surveyor's testimony, it is clear that the deficiency citation was based
on Petitioner's failure to provide the necessary monitoring of Resident
19's condition, which resulted in a deterioration of her condition. Secondly,
I agree with Petitioner's general premise of the distinction between a
physician and nurse's responsibility for treatment. However, I do not
agree with the application of that distinction to the facts in this case.
I agree that it is a doctor's, and not a nurse's, responsibility to make
the ultimate judgment calls with regard to a patient's course of treatment.
However, if a physician is not provided with or is unaware of all of the
information related to a particular patient's condition, he is unable
to make an informed decision as to the appropriate course of treatment.
The record is quite clear that, not only did the treating physician fall
short of his duty to provide the necessary care and treatment to Resident
19, in many instances he was unaware of the resident's condition because
the nursing staff failed to contact him or provide him with full information
of Resident 19's condition. With respect to Petitioner's second asserted defense,
the weight of the evidence clearly shows that Petitioner failed to provide
the resident with the necessary care required to ensure the "highest practicable
physical, mental and psycho social well-being in accordance with a comprehensive
assessment and plan of care" as prescribed in section 483.25. On May 10,
1999, the results of Resident 19's laboratory work up showed the elevated
BUN level of 50. The attending physician was advised by the nursing staff
of this result and the physician directed that the Lasix dose be suspended
for one day, to be resumed the following day, and that follow-up lab tests
should be conducted in two weeks. HCFA Ex. J-8 at 22. Mr. Kirwan, a surveyor
and a registered nurse since 1984, testified that withholding the administration
of the Lasix as instructed by the attending physician was appropriate.
However, being trained medical professionals, the nursing staff should
have questioned resuming the Lasix doses the following day without knowing
whether Resident 19's BUN level was diminished or that the dehydration
issue had been resolved. Tr. at 129, 130, 132. Mr. Kirwan further testified
that, based upon his review of Petitioner's records, there is no indication
that prior to resuming the Lasix doses, the nursing staff attempted to
contact the attending physician for clarification of this course of treatment.
Id. at 133. In its brief, Petitioner asserts that it is not the
job of a nurse to countermand a physician's orders. They can "only exercise
their nursing judgment." P. Br. at 45. I agree with this argument. And
in this instance, it is obvious that the nursing staff did not use their
nursing judgment when it came to resuming the Lasix. I agree with the
conclusions of the witness. Where a nurse has a question as to physician
orders they are to carry out, that question should be brought to the physician's
attention if nothing more than for instructional clarification. I am persuaded
by HCFA's assertion that Petitioner's argument on this point is contradicted
by the nursing staffs own actions in a related matter. HCFA Reply Br.
at 15. I therefore find that Petitioner was not in substantial compliance with Medicare participation requirements under 42 C.F.R. � 483.25.
Following the August 1999 survey, HCFA cited Petitioner
with four deficiencies, specifically the subsection of the regulations
concerning Notice of Rights and Services, 42 C.F.R. � 483.10(b)(3); Quality
of Care, 42 C.F.R. � 25; Quality of Care - Unnecessary Drugs, 42 C.F.R.
� 25(l)(1); and Pharmacy Services - Drug Regimen Review, 42 C.F.R. � 60(c)(2).
Resident 9 Resident 9 was a 73-year-old female. She was diagnosed
with diabetes mellitus, congestive heart failure, peripheral vascular
disease, anemia, bladder cancer, diabetic retinopathy, macular degeneration
and a history of a left "below the knee" amputation. HCFA Ex. A-11 at
10. On July 9, 1999, Resident 9 was admitted to Petitioner's facility. Based upon the evidence, there is a question as to whether Resident 9 was admitted to Petitioner's facility from her home (HCFA Ex. A-11 at 28-29, 99) or from an acute care hospital (id. at 7, 13). HCFA Ex. A-11 at 28-29, 99. She was described as alert and oriented, and the record indicates that she could direct and actively participate in her care. HCFA Ex. A-11 at 31, 50. The purpose for her admission into Petitioner's facility was for refit and replacement of an ill fitting prosthesis on her lower left leg. HCFA Exs. A-11 at 28, 29, 31. The resident's current prosthesis no longer fit appropriately due to weight loss. Id. at 25, 28, 29. She was to receive training in the use of the new prosthesis and therapy to improve her strength. HCFA Ex. A-11 at 31, 33, 106, 142. Upon completion of Resident 19's refit and rehabilitative therapy, she was to be returned to her home. Id. at 50, 94. During the course of what was to be a short-term stay, Resident 19's physical condition began to deteriorate with the change in her body chemistry readings, and the development of edema in her lower right leg, and a hypertensive episode.
As a result of the August 1999 survey, Petitioner was
cited with a deficiency in the Notice of Rights and Services category.
42 C.F.R. � 483.10(b)(3) states:
Specifically, the surveyor alleged at F Tag 154 of the
August 1999 survey that Petitioner failed to comply with the requirements
of 42 C.F.R. � 483.10(b)(3) in that Resident 9 was not advised by the
attending physician of the treatment options available. HCFA Ex. A-11
at 5. HCFA asserts that Dr. Suresh Patel, the attending physician
for Resident 9, did not discuss the applicable courses of treatment for
her various ailments. Petitioner contends that, although the regulations require
that a resident be informed of total health status, there is nothing in
the regulations to suggest that this information be communicated by a
physician. P. Br. at 46. Petitioner further asserts that it is standard
practice in the SNF environment for the nursing staff to provide a resident
with information regarding treatment options and health status. Id. Where this may be the standard operating practice in the
long-term care setting, there is nothing in the record to indicate that
even the nursing staff discussed treatment options or provided regular
updates to Resident 9 as to the status of her health. The nurse's admit notes for July 13, 1999 reflect that
Resident 9 was alert and oriented as to person, place, and time. HCFA
Ex. A-11 at 50. She was verbally able to express her needs. Id.
The nurse's notes also indicated that the resident advised that she wanted
to be "DNR" or Do Not Resuscitate, she wanted no cardiopulmonary resuscitation
(CPR), and she did not want 911 to be called. Id. A DNR statement
was ordered by Dr. Patel on July 15, 1999. Id. at 3. At admission, Resident 9's sole purpose for being in the
Petitioner's facility was for a refit of her prosthesis and therapy associated
with the prosthesis replacement. HCFA Ex. A-11 at 28, 29, 31. On July
9, 1999, a complete blood culture (CBC) was ordered for Resident 9. Id.
at 43. On July 13, 1999, Dr. Patel examined Resident 9. Id. at
51. At that time, he ordered a follow-up CBC to be conducted in three
weeks, as well as ordered medication for the treatment of the resident's
groin rash. Id. On July 14, 1999, the nursing staff noted edema
to the resident's lower leg, foot, and both hands. The nursing staff also
noted the draining of blood tinged urine from Resident 9's Foley catheter.
Id. at 52. Dr. Patel was advised of the edema and prescribed Diazide
to counteract the swelling.(1) At all times in the nurse's notes, Resident 9 is described
as being alert and verbally responsive to stimuli. Id. at 52, 53,
54, 55, 56. On July 25, 1999, the nurse's notes indicate increasing
concern for Resident 9's health status. She is producing less of a urine
output, what is being excreted contained moderate blood clots, and the
resident indicated that with the passage of water, she was relieved of
abdominal discomfort. Id. at 58. Dr. Ramanon, Dr. Patel's partner
and the physician covering for him during this time, was made aware of
the resident's current condition. Id. He advised that Dr. Lynch,
Resident 9's attending urologist, should be consulted for a bladder irrigation.
Id. Dr. Lynch was made aware of the resident's condition and ordered
a STAT CBC and chemistry profile. He further instructed that he was to
be notified immediately upon receipt of the test results. Id. at
59. The CBC results were received by the nursing staff on July 26th.
Id. The lab results indicated, among other things, an elevated
potassium level (5.8), a decreased sodium level (123), an elevated glucose
of 156, a low chloride of 91, a low hematocrit and hemoglobin count, and
an electrolyte imbalance. Id. at 59. Dr. Lynch was advised by the
nursing staff. He indicated, on July 26th, that he would provide
Dr. Patel with the laboratory results. Id. at 60. The nursing staff
did not communicate with Dr. Patel on this matter until the morning of
July 27th, at which time he asked if the resident was "DNR"
and ordered that the current course of treatment remain the same. Id.
at 61. During this period, Resident 9 also continued to experience edema
in her extremities. On July 29th, Dr. Patel ordered that the
Diazide be discontinued and that Lasix (another diuretic) be administered
in its place. Id. at 39. In addition, Dr. Patel ordered that K-Dur
supplements be given to Resident 9 as well. Id. K-Dur is a potassium
supplement. It was not until August 3, 1999 that Resident 9 was advised
of any information relating to the nature of her health. The nursing staff
noted that the resident had produced no urine output for an 8-hour period
and, upon advising Dr. Lynch, were directed to admit the resident to the
Prince George's County Emergency Room if there continued to be no urine
output. Id. at 65. Upon receipt of these orders from Dr. Lynch,
Resident 9 was then made aware of Dr. Lynch's orders. Id. In accordance with orders previously given by Dr. Patel,
a complete CBC was conducted and the results received on August 11, 1999.
Id. at 67. The results indicated that Resident 9's hematocrit level
had decreased to 24.6 (compared to 29.6 on July 25th), and
her hemoglobin count had dropped to 8.1. Id. at 67. Two calls were
placed to Dr. Patel to advise him of the lab results. At that time, Dr.
Patel informed the nursing staff that he would not treat the resident
to counteract the current test findings. The nursing staff informed Dr.
Patel of the resident's complaints regarding lower abdominal pain and
that she is still passing blood in her urine. Id. at 68. Dr. Patel
stated the resident was DNR, and since her vital statistics were stable
and she registered no new complaints, he would not treat her current maladies.
Id. Resident 19 continued to experience edema and lower abdominal
pains. There is no indication in the record that either Dr. Patel
or the nursing staff spoke with Resident 9 regarding the current
course of events until August 26th when the question of a blood
transfusion became an issue. Id. at 83. In each instance where
Petitioner initiated communications with Resident 9 regarding her health
and any prospective course of treatment, the necessity for action became
immediate. Resident 9 should have been consulted as to the state of her
health, regardless of the fact that she had terminal bladder cancer by
this time. Preliminary measures could have been initiated prior to the
necessity, for example, for a blood transfusion. In fact, remedial measures
could have been taken to avoid the changes in the resident's physiology.
However, the attending physician opted not to take any preventive measures,
supposedly based upon the resident's DNR status. In light of the evidence presented, I find that Petitioner was not in substantial compliance with participation requirements specified in 42 C.F.R. � 483.10(b)(3) regarding disclosure of the nature and state of Resident 9's medical condition.
As a result of the August 1999 survey, Petitioner was
cited a deficiency in the Quality of Care category. The requirements of
42 C.F.R. � 483.25 have been previously discussed in section V(B) above. Specifically, at F Tag 309 of the August 1999 survey,
it was determined that Petitioner failed to provide the necessary care
and services to Resident 9 through various means. HCFA Ex. A-11 at 5.
The surveyor utilizes the events and circumstances discussed at section
V(C)(1) above as his rationale for the deficiency citation presently at
issue. Petitioner contends that the deficiencies were cited,
not because Petitioner provided inadequate care to Resident 9, because
the surveyor substituted the medical judgment of the treating physicians
with his own judgment. P. Br. at 45. I do not agree with Petitioner's
supposition. The surveyor, William Vaughan, testified that the purpose
for the revisit survey was to ascertain whether the F Tag 309 deficiency,
cited in the June 1999 survey, had been corrected. Tr. at 419. In accomplishing
this goal, Resident 9's patient records were just one record of 13 reviewed
for this purpose. However, it was these records in particular which raised
questions as to potential deficiencies. HCFA Ex. A-11 at 5.
Based on the factual discussion and analysis addressed
above, I find that Petitioner was not in substantial compliance with the
participation requirements under 42 C.F.R. � 483.25. It is evident from the resulting dehydration and other
related ailments which manifested in Resident 9 that Petitioner did not
provide the "highest practicable physical well-being in accordance with
a comprehensive assessment . . . ." 42 C.F.R. � 483.25. Based on the record,
the only treatment Resident 9 refused was any sort of resuscitative measures.
This is clear from the DNR order signed by the resident and made effective
as of July 17, 1999. HCFA Ex. A-11 at 3; see also, id.
at 8; id. at 50 (7/13/99 Nurse's Note - "She said she wanted to
be DNR no CPR and did not want 911 called."). In addition, the surveyor,
Mr. Vaughan, testified that the resident advised him on August 26th
that the only treatment she declined was CPR. Tr. at 506-507. This evidence
is contrary to Dr. Patel's repeated assertions that he was informed of
the resident's wishes to be "comfort care only." Tr. at 515, 1837.
The evidence also contradicts the references in the nurse's notes
that, after inquiries by Dr. Patel as to the resident's DNR status, he
took no revised or additional measures to address Resident 9's increasing
medical issues, e.g., dehydration status. HCFA Ex. A-11 at 61, 68. Mr.
Vaughan further testified that, upon questioning the facility staff and
officials during the survey, he was able to conclude that not one of the
individuals interviewed was aware that Resident 9 was "comfort care only."
Tr. 511-515; HCFA Ex. A-10 at 5. At the hearing, Dr. Patel was unclear as to his source
for the above-referenced information. He testified at one point that the
information was derived from the nursing staff. Tr. at 1852. In another
instance, he stated that the information was obtained from Dr. Lynch,
the attending urologist. Tr. at 1856. He also testified that he spoke
with the resident on July 30th. However, he did not document
her wishes for comfort care. Tr. at 1854-55. Whatever the source of his
knowledge, Dr. Patel did not speak with Resident 9 as to her treatment
wishes prior to July 30th. Grounded on inaccurate presumptions as to the resident's wishes as to acceptable courses of treatment, it is easy to conclude that these misperceptions caused Dr. Patel to withhold certain treatment which, if administered sooner, may have circumvented the resident's dehydrational decline.
As a result of the August 1999 survey, Petitioner was cited with a second deficiency in the Quality of Care category. 42 C.F.R. � 483.25(l)(1) states:
To support the allegation that Petitioner failed to comply
with this requirement, the situation of Resident 9 is detailed at F Tag
329 on the HCFA 2567. HCFA Ex. A-5 at 15-16. The preponderance of the evidence shows that Petitioner
was not in substantial compliance with participation requirements specified
in 42 C.F.R. � 483.25(l)(1), regarding unnecessary drugs, at the time
of the August 1999 survey. The essence of this alleged deficiency is that the attending
physician prescribed a potassium supplement (K-Dur) to a resident with
a known elevated potassium level and failed to order subsequent monitoring
of the resident's potassium level. Id. at 16. The surveyor further
asserted that there was a failure by the nursing staff to question this
course of action, and a failure by the pharmacist to intervene when a
drug regimen review has been conducted. Id. Petitioner contended that potassium is not a drug; that it is an unprescribed mineral that can be acquired at any grocery or health food store. P. Br. at 56. Petitioner goes further to assert that, even if potassium is considered a drug, it is not a drug covered by F Tag 329. Id. Petitioner argues that the types of drugs covered under F Tag 329 are pharmacological in nature, or drugs of a type used to control and treat behavioral problems. Id. I am not persuaded by Petitioner's assertions. They have
not proven to my satisfaction that, for these purposes, potassium would
not be considered a drug. I accept Dr. Levinson's explanation of what
constitutes a "drug." Further, in being one of the contributors to the
drafting of the Guidance to Surveyors, in particular the section related
to "unnecessary drugs," Dr. Levinson is in a better position to provide
insight as to the intent in the drafting of this particular section of
the Guidelines. In addition, there is the testimony of Dr. Judy Curtis,
a skilled pharmacist, to support the testimony of Dr. Levinson. Petitioner attempts to paint a picture in which Dr. Levinson's testimony supposedly indicated that everything, with the exception of water, would be considered a drug by his definition. P. Br. at 56, fn. 5. Petitioner's interpretation is overly broad. Dr. Levinson testified that:
Tr. at 1787. Dr. Curtis later testified that K-Dur, the substance prescribed
by Dr. Patel on July 29th, which is indeed a potassium supplement is one
which is considered to be a prescribed drug. Tr. at 1938-39. Having determined that potassium, in this instance, is
a drug, I find that in having ordered the potassium to be administered
to Resident 9, monitoring of the potassium level should have been ordered
whether her level at that particular time was moderate or excessive. Petitioner's argument concerning the issue of monitoring the potassium level goes strictly to the premise that a deficiency under F Tag 329 is applicable only when residents are needlessly prescribed medication. However, to the contrary, 42 C.F.R. � 483.25(l)(1) specifically dictates that:
42 C.F.R. �� 483.25 (l)(1)(iii), (v), and (vi). On the admission assessment report, the nursing staff
noted that Resident 9's potassium level was 4.1 which, utilizing the scale
used by the facility lab, is within the normal range (3.6-5.0). HCFA Ex.
A-11 at 25. To counteract the edema Resident 9 was experiencing in her
extremities, Dr. Patel prescribed Diazide on July 14th. Id.
at 35. Also during this period, Resident 9 was experiencing a decreased
urine output and consistently producing blood in that output. Id.
at 51-54, 56-58; Tr. at 696. This condition, if not corrected, will ultimately
result in volume depletion. Volume depletion increases the possibility
of elevated potassium levels. Tr. at 1764. Diuretics are also known to
contribute to volume depletion. Id. at 121. There is nothing in
the nurse's notes to indicate that instructions were given by Dr. Patel
to monitor Resident 9 in light of her constant bleeding and the commencement
of the diuretic. Because of the ongoing presence of blood in Resident
9's urine, Dr. Lynch ordered a STAT CBC on July 25th . HCFA
Ex. A-11 at 59. The test results were reported to the nursing staff on
July 26th. Id. Among other things, the lab tests showed
an increased potassium level of 5.8. Id. Dr. Lynch was advised
of the results and informed the nursing staff that he would contact "the
primary care physician." Id. at 60. On July 27th, Dr. Patel
contacted the nursing staff regarding the lab results. Id. at 61.
He inquired whether the resident was "DNR" and ordered that the current
course of treatment remain the same. Id. at 61. When asked why
he took no action at this time, Dr. Patel testified that he wanted to
observe. Tr. at 1839. He went further to admit that the cause of the elevated
potassium level could have been one of the diuretics or medications Resident
9 was being administered at that time. Id. It wasn't until two
days later, on July 29th, that the Diazide was ordered discontinued
and substituted with Lasix (another diuretic) and K-Dur (a potassium supplement).
HCFA Ex. A-11 at 39. After the commencement of the new medication regimen,
Dr. Patel did not order monitoring or any further testing of Resident
9's potassium level. Dr. Patel testified that he did not consider 5.8
to be a life-threatening condition and therefore immediate action was
not required. Tr. at 1840. I am not persuaded by the proposition set forth by Petitioner.
It is apparent that Resident 9 suffered from bladder cancer. This information
was known to the facility and Dr. Patel very early on. HCFA Ex. A-11 at
10, 13, 24, 25, 29, 32; Tr. at 1831, 1832. Dr. Patel was aware of the
blood present in Resident 9's urine and that this was the result of the
bladder cancer, and therefore concluded that nothing more could be done
to treat the bladder cancer. HCFA Ex. A-11 at 68, 71. Whereas
this conclusion may have been accurate with regard to the cancer, I am
not convinced that there was nothing to be done as far as preemptive measures
in dealing with the medical conditions occurring as a result of the cancer
and medication regimen. At best, in light of the changing state of Resident
9's condition and the altering of her body chemistry since her admission
to the facility, monitoring could have been ordered and alternate measures
taken to address the potassium increase. Furthermore, Dr. Patel testified
that, during this period of time although he may have been aware of Resident
9's cancer, he did not know how far it had progressed. Tr. at 1834. This
was the rationale for the July 30th notation where a question
mark was written before the entry relating to the bladder cancer. Id.
at 1834; See also HCFA Ex. A-11 at 32. If Dr. Patel was
unaware of the progression of the bladder cancer, how was he able to conclude
that there was no course of action available to counteract, among other
things, the potassium increase? It appears that Dr. Patel's conclusions
were premature and further measures should have been taken. Based on the evidence elucidated at hearing, I find that Petitioner failed to prove that it was in substantial compliance with the requirements of 42 C.F.R. � 483.25(l)(1).
As a result of the August 1999 survey, Petitioner was cited with a deficiency, specifically subsection of the regulations concerning Pharmacy Services - Drug Regimen Review, which states:
42 C.F.R. � 483.60(c)(2). To support the allegations that Petitioner failed to comply
with the requirements, the situation of Resident 9 is detailed at F Tag
429 on the HCFA 2567. HCFA Ex. A-11 at 16. The preponderance of the evidence shows that Petitioner
was not in substantial compliance with participation requirements, specified
at 42 C.F.R. � 483.60(c)(2) at the time of the August 1999 survey. The surveyor determined that at the time of the drug regimen review, conducted on August 23, 1999, the pharmacist failed to act upon or note that Resident 9 was still being administered K-Dur (potassium) supplements even though:
HCFA Ex. A-11 at 16. Petitioner contends that, since potassium is not a "drug,"
F Tag 429 is therefore inapplicable. P. Br. at 59. Petitioner further
asserts that the reference to Resident 9's elevated potassium level on
July 25, 1999 is irrelevant to the issue of her potassium level on August
21, 1999. Id. Lastly, Petitioner asserts that the federal regulations
only require monitoring within 30 days following the commencement of "diuretic
therapy," and based upon this supposition, Petitioner was therefore in
compliance with this standard. Id. However, if this is the position Petitioner seeks to assert, no affirmative evidence was put forward in support of this contention. The only evidence Petitioner attempts to utilize on its behalf is the testimony of Dr. Karen Babos. Dr. Babos, the Senior Medical Director of HCR Manor Care, concluded that:
P. Br. at 60, (citing Tr. at 683 (sic)(2)). However the testimony of Dr. Judy Curtis, a pharmacological
expert witness, rebutted this presumption and established that:
Tr. at 1939. I am persuaded by this testimony and agree that, under
the circumstances, some further inquiry should have been made by the pharmacist.
There was nothing in the record to indicate that Resident 9's potassium
level had been checked since July 25th. Additionally, no indication was
in the record as to whether, by the August 23rd regimen review,
the potassium level had increased or decreased. These factors should have
raised a question in the pharmacist's mind and a
note in the medical record or even follow-up questions to the attending
physician should have been put forth.
Petitioner argues that HCFA lacked the authority to terminate
their Medicare provider agreement. This contention is based upon the premise
that, due to HCFA's delay in providing the Statement of Deficiency within
10 days of the conclusion of each survey conducted, there was not a six-month
period of noncompliance from the date of the February 1999 survey. P.
Br. at 28. Petitioner avers that pursuant to 42 C.F.R. � 488.110(j), "the
Secretary must inform the facility of Statement of Deficiencies no later
than 10 calendar days following the survey." Id. Petitioner stated that it did not receive the Statement of Deficiencies for 32 days after the February survey, 49 days after the June survey, and 13 days after the August survey. Id. at 27. Petitioner contends that these lapses of time should be subtracted from the six-month period to get an accurate accounting of the period of alleged noncompliance. Id. at 28-29. Petitioner states that, therefore, the termination must be reversed as a matter of law. Id. at 29. The argument Petitioner seeks to assert is an equitable
one. The relief sought is beyond the authority granted to me. Furthermore,
the regulation Petitioner has referenced contains no sanctions for instances
where HCFA fails to provide a statement of deficiencies within 10 days
of the conclusion of a survey. Section 488.110(j) provides that:
As previously affirmed by prior case law, the nursing
home provisions of the Omnibus Budget Reduction Act of 1987 have
effectively made inoperative Subpart C of 42 C.F.R. Part 488, of which
42 C.F.R. � 488.110(j) is a part. See Golden State Manor Nursing
and Rehabilitation Center, DAB CR412 (1996). Therefore, I find that
42 C.F.R. � 488.110(j) is irrelevant to my determination.
Even though HCFA had found Petitioner to be out of compliance with Medicare participation requirements, HCFA did not take immediate steps to impose the remedy of termination. On two occasions, including the period following the August 1999 survey, HCFA allowed Petitioner to pursue Informal Dispute Resolution. See HCFA Exs. 12, 18. The choice to allow alternate means of resolution was within HCFA's discretion. 42 C.F.R. � 488.412. However, when a facility is not in substantial compliance within six months from the last day of a survey from which it was found to be out of compliance, HCFA will terminate the facility's provider agreement. Id. Petitioner was not in substantial compliance at the time of the February 1999 survey. Nor did Petitioner achieve substantial compliance subsequent to the June 1999 and August 1999 surveys. Where a facility is not in substantial compliance with participation requirements, HCFA may:
42 C.F.R. � 488.412(a)(1) and (2). That choice is within HCFA's discretion. Petitioner was noncompliant from the time of the February 1999 survey. Six months later, in August 1999, Petitioner remained noncompliant with participation requirements. Petitioner has assumed that I would find HCFA authorized to terminate Petitioner's Medicare agreement only if Petitioner remained out of substantial compliance continuously for six months. Petitioner presented evidence to support its contention that, based on HCFA's failure to provide Petitioner with statements of deficiencies within 10 days of the completion of each survey, there was not a continuous six-month period of noncompliance. This is an incorrect assumption. HCFA's termination letter dated October 27, 1999 notified Petitioner that its Medicare agreement was be terminated because it:
HCFA Ex. 20 at 1. HCFA's termination letter does not allege
that the basis for termination is Petitioner's failure to come within
substantial compliance within a six-month period. I find that the reference
at the end of the October 27th letter is merely a recitation
of the applicable law under which HCFA will terminate the participation
of any facility not found to be in substantial compliance with Medicare
participation requirements. Under such conditions, HCFA is authorized
to terminate Petitioner's Medicare agreement. 42 C.F.R. �� 488.456(b)(i)
and 489.53(a)(3). Petitioner was not in substantial compliance with participation
requirements at the time of the February, June, and August 1999 surveys.
Consequently, HCFA is authorized to terminate Petitioner's Medicare agreement. VI. Conclusion Petitioner was not in substantial compliance with Medicare participation requirements at the time of the February, June, and August 1999 surveys. Therefore, HCFA was authorized to terminate Petitioner's Medicare agreement. |
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JUDGE | |
Jill S. Clifton Administrative Law Judge
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FOOTNOTES | |
1. Diazide is a potassium-sparing diuretic. 2. In its brief, Petitioner mistakenly cited "Tr. at 683." The correct citation is Tr. at 647. | |