$05:Exclusion Case
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
Mildred J. Stevens, M.D.,
Petitioner,
- v. -
The Inspector General.
DATE: May 9, 1994
Docket No. C-93-057
Decision No. CR314
DECISION
By notice letter dated February 11, 1993, the Inspector General
(I.G.) informed Petitioner of her determination that, in a single
instance involving a newborn patient named Amanda, Petitioner had
grossly and flagrantly violated her professional obligations under
section 1156(a)(2) of the Social Security Act (Act). 1/ Using the
problems identified in Petitioner's care of Amanda and 13 other
patients, the I.G. determined also that Petitioner had demonstrated
an unwillingness or inability to substantially comply with the
obligations imposed on her by section 1156(a)(2) of the Act. The
I.G. notified Petitioner that she was to be excluded from
participation in the Medicare, and any State health care program as
defined in section 1128(h) of the Act, for a period of three years.
2/
On February 13, 1993, the I.G. sent Petitioner another letter to
inform her of her option to have the effective date of the
exclusion stayed pending an evidentiary hearing on the issue of
whether she poses a serious risk to patients. Section 1156(b)(5)
of the Act specifies such an option for program providers whose
practices are located in a rural health manpower shortage area or
in a county with a population of less than 70,000. Petitioner
requested a hearing on the serious risk issue and also on the issue
of whether there was a gross and flagrant violation of her
professional obligations. The case was assigned to me for a
hearing and a decision.
In my prehearing order dated April 6, 1993, I noted additional
relevant procedural history on the serious risk issue. 3/ I denied
the I.G.'s motion that I hold a separate hearing on that issue.
However, in ruling that the hearing on all issues should be
consolidated, I granted the I.G.'s motion that I issue an expedited
ruling on the serious risk issue.
I held an in-person hearing in this case on September 13 and
September 14, 1993 in Kansas City, Missouri. At the close of the
hearing, I established a schedule for the parties to brief the
issues before me. On December 16, 1993, I issued a ruling in which
I found that Petitioner posed a serious risk to patients and
directed that the exclusion be implemented immediately pending a
final decision in this case. My December 16th ruling did not
address the issues of whether the I.G. had authority to exclude
Petitioner or whether the exclusion imposed against Petitioner by
the I.G. is reasonable. In my ruling on serious risk, I extended
the parties' deadline for filing briefs on the remaining issues.
By ruling dated December 16, 1993, I denied Petitioner's motion to
supplement the record with a memorandum prepared by Dr. David
Johnsen for Petitioner's defense of a medical malpractice lawsuit.
Thereafter, on December 22, 1993 (by correspondence pro se) and on
January 14, 1994 (by correspondence through counsel), Petitioner
attempted to file the same memorandum by Dr. Johnsen once again,
along with a copy of a document that was already admitted into the
record at hearing as Petitioner's Exhibit 19. Petitioner has not
explained why her Exhibit 19 should be admitted a second time, and
her reasons for resubmitting the same memorandum from Dr. Johnsen
do not establish any good reason for me to modify my earlier denial
of her first motion. Therefore, I am denying her motions of
December 22, 1993 and January 14, 1994 to supplement the record
with the same memorandum.
Having considered the applicable legal principles, the evidence I
received at hearing, and the arguments raised by the parties in
their posthearing briefs and other submissions, 4/ I conclude that
the I.G. proved that she had the authority under section 1156 of
the Act to impose and direct Petitioner's exclusion from
participating in Medicare and Medicaid. I find also that the
three-year exclusion is reasonable.
ISSUES
The issues in this case are:
1. Whether Petitioner has grossly and flagrantly violated her
obligations under section 1156(a)(2) of the Act;
2. Whether Petitioner has demonstrated a lack of ability or
unwillingness to comply with her obligation under section
1156(a)(2) of the Act; and
3. Whether the three-year exclusion imposed and directed by
the I.G. is reasonable.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
Statutory and regulatory framework
1. The Kansas Foundation for Medical Care, Inc. (KFMC) is a peer
review organization (PRO), within the meaning of section 1154 of
the Act.
2. The PRO's duties include reviewing the professional activities
of physicians in Kansas for the purpose of determining whether the
quality of services that physicians provide to Medicare
beneficiaries and Medicaid recipients meets professionally
recognized standards of health care. Social Security Act, section
1154(a)(1)(B); 42 C.F.R. 1004.10(b).
3. Professionally recognized standards of care are "statewide or
national standards of care, whether in writing or not, that
professional peers of the individual or entity whose provision of
care is an issue, recognize as applying to those peers practicing
or providing care within a State." 42 C.F.R. 1001.2.
4. A PRO has the discretion to establish specific criteria and
standards to be applied to certain locations and facilities in the
PRO area if the PRO determines that both the following conditions
have been satisfied:
(a) the patterns of practice in those locations and facilities
are substantially different from patterns in the remainder of the
PRO area; and
(b) there is a reasonable basis for the difference which makes
the variation appropriate.
5. 42 C.F.R. 466.100(d).
6. Where the PRO has determined that a physician has violated the
obligation to provide services of a quality that meets
professionally recognized standards, the PRO is required to give
the physician reasonable notice and an opportunity for discussion,
and, if appropriate, a suggested method for correcting the
situation during a designated period of time under a corrective
action plan. 42 C.F.R. 1004.30(c), 1004.40(c)(4).
7. If a physician has grossly and flagrantly violated the
aforesaid obligation in one or more instances, the PRO must also
submit a report of the violation to the I.G. 42 C.F.R.
1004.30(c).
8. A "gross and flagrant violation" is the violation of an
obligation to provide care in one or more instances which presents
an imminent danger to the health, safety, or well-being of a
Medicare beneficiary or places the beneficiary unnecessarily in a
high-risk situation. 42 C.F.R. 1004.1(b).
9. The Secretary of the Department of Health and Human Services,
or by delegation, the I.G., may impose and direct the exclusion of
a health care practitioner from participating in Medicare and
Medicaid where the Secretary determines, based on a recommendation
by a PRO, that the practitioner has: (1) in one or more instances,
grossly and flagrantly violated the obligation to provide health
care of a quality which meets professionally recognized standards
of care; and (2) demonstrated an inability or unwillingness to
substantially comply with the obligation to provide such care.
Social Security Act, section 1156(b)(1).
10. In determining the appropriateness of a sanction after the
practitioner has been found to have grossly and flagrantly violated
the aforesaid obligation, the I.G. must consider factors that
include the PRO's recommendations, the type of offense at issue,
the severity of the offense, the availability of alternate sources
of service in the community, and whether the practitioner has
entered into corrective actions plans (CAPs) prior to the PRO's
recommendation and, if so, whether she has successfully completed
such plans. 42 C.F.R. 1004.90(d).
11. A party subject to an exclusion determination under section
1156(b)(1) of the Act has a right to a de novo administrative
hearing on all relevant issues. Section 205(b) of the Act (as
incorporated by section 1156(b)(4) of the Act).
Background facts
12. In the notice letter, the I.G. imposed and directed an
exclusion on the basis of the PRO's finding that Petitioner, in
treating a newborn patient named Amanda, had grossly and flagrantly
violated her obligation to provide services of a quality that meets
professionally recognized standards of health care. I.G. Ex. 25.
13. Petitioner delivered Amanda on May 19, 1991 at Anderson County
Hospital. I.G. Ex. 1.
14. After the delivery, Petitioner also cared for Amanda at
Anderson County Hospital, until the afternoon of May 20, 1991. Id.
15. Anderson County Hospital is a small hospital located in
Garnett, Kansas. Tr. at 553; I.G. Ex. 1.
16. Garnett, a rural community of approximately 3200 people, is
the county seat of Anderson County, Kansas, which has a population
of 7000. Tr. at 413.
17. Petitioner has practiced general medicine in Garnett, Kansas,
since 1948. Tr. at 468 - 69.
18. Of the approximately 4000 babies Petitioner has delivered over
the past 45 years, only a few were delivered by Petitioner during
the years immediately preceding Amanda's birth. I.G. Ex. 14 at 47,
66; Tr. at 554 - 56.
19. Few babies with health conditions like Amanda's have been born
at Anderson County Hospital. Tr. at 450, 504 - 05.
20. Petitioner has 4000 active patient charts, of which 50 percent
are for Medicare beneficiaries and Medicaid recipients. Tr. at
580.
21. During the period in issue, there were five doctors practicing
medicine in Garnett: Petitioner, who practiced full time; two
other doctors, who practiced full time; a doctor who practiced part
time; and another doctor who occasionally treated patients. I.G.
Ex. 17 at 2.
22. Petitioner's husband, who also was on the medical staff of
Anderson County Hospital, was included among the physicians
practicing in Garnett. Tr. at 409 - 10.
23. All five doctors on the medical staff of Anderson County
Hospital were eligible to vote on applications (including their
own) for privileges to practice particular types of medicine at
that hospital. Tr. at 407 - 10.
24. In 1991, Petitioner and Dr. David Henderson were the only
physicians practicing obstetrical medicine in Garnett and at
Anderson County Hospital. Tr. at 397.
25. At the time Petitioner delivered and cared for Amanda,
Petitioner was the chief of the obstetrical department at Anderson
County Hospital. Tr. at 371.
26. At the time of Amanda's birth, Dr. Henderson was the chief of
the pulmonary medicine department and the emergency department, as
well as the chief of staff at Anderson County Hospital. Tr. at
362, 460 - 61.
27. The foregoing titles do not signify medical expertise in the
respective fields because, due to the small size of the medical
staff, the department chief positions are given to whichever
doctors are willing to assume them. Tr. at 461.
28. Dr. Henderson saw Amanda on the night of her birth in his
capacity as the chief of staff for Anderson County Hospital. Tr.
at 366, 430 - 34.
29. Both Petitioner and Dr. Henderson have been sued in a
malpractice action involving the care given to Amanda. Tr. at 446
- 47.
30. During the time that Petitioner delivered and cared for Amanda
at Anderson County Hospital, some health care employees of the
hospital disagreed with Petitioner's actions and decisions with
respect to Amanda's treatment. See, e.g., Tr. at 430, 487 - 88;
I.G. Ex. 1 at 17.
31. After Amanda's birth, Anderson County Hospital suspended
Petitioner's privileges to practice obstetrical medicine there.
Tr. at 407 - 10.
The applicable "professionally recognized standards of health care"
32. Neither the I.G. nor the PRO had attempted to develop or apply
any professionally recognized standards of health care that are
unique to Anderson County Hospital or Garnett, Kansas. Tr. at 45
- 46; P. Br. at 7.
33. The PRO applied a statewide standard in evaluating the quality
of care at issue. Tr. at 46 - 47.
34. The focus of the inquiries by the I.G. and the PRO was whether
Petitioner had certain minimum medical knowledge of a sufficiently
current nature that would enable her to provide reasonably
up-to-date care that meets currently recognized standards of health
care. Tr. at 39, 42, 285; I.G. Ex. 21 at 2.
35. No matter where a physician practices, there are minimum
professional standards that each physician must satisfy under the
Act. Tr. at 285; see section 1158(a)(2) of the Act.
36. Petitioner recognizes that a physician must have the requisite
knowledge base in order to make use of available resources, tests,
or procedures in the physician's treatment of patients. I.G. Ex.
14 at 7.
37. Anderson County Hospital had the basic resources and equipment
-- e.g., oxygen, a delee catheter, a fetalscope or fetal monitor,
a telephone -- that would have enabled a physician to assess and
treat Amanda in the manner described by the I.G.'s experts. Tr. at
203 - 04, 406, 437, 452; I.G. Ex. 1 at 17 - 20, 45 - 49.
38. There has been no effort by the PRO or the I.G. to hold
Petitioner to a standard of care applicable to medical specialists
or to physicians practicing in large urban health care facilities
with state-of-the art equipment. Tr. at 285, 350 - 51.
39. Petitioner does not contend that she would have given
different treatment to Amanda had Petitioner been practicing in a
different hospital with different resources or more advanced
technologies. See Tr. at 501 - 09.
40. The issues in this case do not involve a physician's need to
accommodate geographical differences or limitations in available
health care resources in order to avoid placing her patients
unnecessarily in high-risk situations.
41. Given the unique issues and factual background of this case,
the PRO and the I.G. were not required to develop any relevant
professionally recognized standards of health care that are unique
to Anderson County Hospital or Garnett, Kansas. See Findings 31 -
39.
42. In alleging local standards as an affirmative defense,
Petitioner has not proven that there exists local factors or
standards of practice in Garnett or Anderson County Hospital that
would eliminate a physician's need to have at least a minimal level
of reasonably up-to-date knowledge concerning those commonly known
medical facts and procedures which will enable the physician to
meet patients' needs by making appropriate use of available medical
resources.
43. The evidence does not credibly establish the existence of any
relevant pattern of practice in Garnett or Anderson County Hospital
that is substantially different from the patterns of practice in
the rest of Kansas, which has many other small rural communities as
well. See 42 C.F.R. 466.100(d); Findings 31 - 40; P. Ex. 10.
44. The evidence also does not establish the existence of a
reasonable basis for any variation between whatever pattern of
practice may exist in Petitioner's locality or at Anderson County
Hospital and the pattern of practice in the rest of Kansas. See 42
C.F.R. 466.100(d); Findings 31 - 37.
45. The evidence does not establish that Petitioner's treatment of
Amanda conformed to any professionally recognized standards of
health care. See P. Exs. 1 - 4, 8, 9; Tr. at 439.
46. Petitioner's actions at issue cannot constitute a
professionally recognized standard within the meaning of the Act,
even though she has no doubt contributed significantly to shaping
the quality level of the treatment available to patients in Garnett
and at Anderson County Hospital due to the length of her
professional career, the small size of the medical staff, her high
number of patients, and her having been only one of two doctors
practicing obstetrics in the area until her hospital privileges
were revoked. Section 1156(a)(2) of the Act; Findings 31 - 44.
47. The PRO and the I.G. correctly applied an appropriate standard
in this case. Findings 31 - 45.
Petitioner's delivery and treatment of Amanda
48. When Petitioner went to the hospital on May 19, 1991 to
deliver Amanda, Petitioner was aware that the nursing staff had
independently requested the assistance of a respiratory therapist
(RT), that an RT was not called for normal deliveries, and that
there was an unspecified "disagreement" or an "electric charged
situation" between herself and the nurses that began prior to
delivery. Tr. at 475 - 76, 478, 495.
49. Petitioner did not ask why an RT had been called or why the
nursing staff seemed concerned about potential complications in the
delivery. Id.
50. Petitioner stated that giving birth is a normal physiological
process and, if given enough time and emotional support, most women
will deliver a baby that is alive. I.G. Ex. 22 at 2.
51. Petitioner stated also that "to cut a baby out" ruins a mother
forever and reflects little skill or patience on the part of a
physician. Id.
52. Petitioner failed or refused to recognize the significance of
heavy meconium staining in the amniotic fluid when Petitioner
ruptured the fetal membrane at 5:06 p.m. on May 19, 1991. Tr. at
131, 134 - 35, 284 - 85, 485; I.G. Ex. 1 at 45.
53. In accordance with professionally recognized standards of
health care, Petitioner should have recognized meconium aspiration
as a sign of fetal distress and related to the birth of infants
suffering from severe respiratory depression. Tr. at 133 - 35; P.
Exs. 1 - 4.
54. Twenty-four minutes after the heavy meconium staining
appeared, Petitioner was informed that the fetal heart rate had
dropped from 136 to 64. I.G. Ex. 1 at 17, 45.
55. Petitioner ordered the staff to cease monitoring the fetal
heart rate after it decreased to 64. Id.
56. Petitioner failed or refused to recognize the significance of
the drastic reduction in Amanda's fetal heart tone. Findings 51 -
54; Tr. at 131, 201 - 02.
57. In accordance with professionally recognized standards of
health care, Petitioner should have known that a fetal heart rate
of 64 was an additional sign of fetal distress, and she should have
ordered continuous monitoring of the fetal heart rate. Tr. at 131
- 32, 281; P. Ex. 3.
58. Petitioner did not order the RT to enter the delivery room
even when the fetal heart rate had dropped to 64. Id.; Tr. at 476.
59. In accordance with professionally recognized standards of
health care, Petitioner should have given the RT instructions in
preparation for the baby's potential problems during and after
delivery. Tr. at 131 - 32, 287 - 88.
60. In accordance with professionally recognized standards of
health care, Petitioner should have known to order oxygen therapy
promptly by the two signs of fetal distress: the heavy meconium
staining that was present at 38 minutes before Amanda's birth, and
the significantly decreased fetal heart rate that occurred at 14
minutes before Amanda's birth. Tr. at 201.
61. Petitioner did not order the RT to begin oxygen therapy until
two minutes before Amanda was born. Tr. at 201 - 02; I.G. Ex. 1 at
17, 45; I.G. Ex. 21 at 3.
62. With the initiation of oxygen therapy at two minutes before
Amanda's birth, the fetal heart rate increased to 96. I.G. Ex. 1
at 45.
63. Petitioner incurred an unnecessary delay of up to 36 minutes
in ordering oxygen therapy because she failed or refused to
recognize the signs of fetal distress. Findings 52 - 61; Tr. at
201 - 02.
64. Amanda's life and health were placed unnecessarily at high
risk by Petitioner's failure or refusal to recognize the signs of
fetal distress, to begin appropriate treatments, and to make
preparations for possible complications in the delivery of an
infant in distress. Findings 51 - 62; Tr. at 134 - 35, 284 - 85.
65. In accordance with professionally recognized standards,
Petitioner should have used the procedure called "suctioning the
baby on the perineum" in delivering Amanda. P. Exs. 1 - 4; Tr. at
132 - 33, 275 - 78, 437, 439.
66. Suctioning the baby on the perineum involves the physicians'
stopping the descent of the baby's head at the mother's perineum
(or bottom) for no more than 10 seconds during delivery in order to
suction out the meconium from the baby's upper respiratory tract at
the earliest time possible while the baby is still attached to the
mother by the umbilical cord and has no need to attempt breathing.
Tr. at 132 - 33, 275 - 76, 282 - 83.
67. Petitioner did not suction Amanda on the mother's perineum
during delivery. Tr. at 277.
68. Because the delivery took six minutes, there was ample time
for Petitioner to suction the baby on the perineum. Tr. at 486,
498; Finding 66.
69. In explaining her standard of care for delivering babies like
Amanda, Petitioner objected to suctioning them on the perineum
because, in her view, the procedure is the equivalent of hanging
the babies by the neck, may cause "neck syndrome," may cause brain
damage, and is related to red patches she has seen on newborns.
Tr. at 482 - 84.
70. Suctioning the baby on the perineum presents no risk to mother
or child. Tr. at 275 - 76, 283.
71. Suctioning the baby on the perineum was not a procedure that
was commonly performed at Anderson County Hospital around the time
of Amanda's birth because few respiratorily depressed babies have
been born at that hospital and Petitioner was one of only two
doctors then delivering babies at that hospital under her own
standard of care. Tr. at 437 - 39, 450 - 01, 504 - 05; Finding 68.
72. Petitioner's failure to suction the baby on the perineum
unnecessarily increased the risk of Amanda's inhaling meconium and
developing additional complications as a result. Findings 64 - 70.
73. When Amanda was born at 5:44 p.m. on May 19, 1991, she was
flaccid, silent, and without spontaneous respiration. I.G. Ex. 1
at 4, 31, 45.
74. Following Amanda's birth, Petitioner placed Amanda
unnecessarily at high risk for additional respiratory
complications, damage to her central nervous system and other
organs, hypothermia, or life-threatening cold stress, by failing to
recognize that Amanda's airways needed immediate and extensive
ventilation, by laying Amanda on her mother's abdomen, and by
merely rubbing Amanda's back. I.G. Ex. 1 at 17, 45; Tr. at 136 -
37, 182, 185 - 87, 292 - 95, 477 - 78, 487 - 88.
75. On her own initiative, the RT entered the delivery room,
removed Amanda from Petitioner's hands and the mother's abdomen,
and placed Amanda on an appropriate surface in a warm environment,
where the RT began suctioning out thick green secretions and later
administered oxygen therapy to the baby by mechanically controlling
the airways. I.G. Ex. 1 at 17 - 18, 45; Tr. at 182, 185 - 87, 292
- 93, 295, 477 - 78, 487 - 88.
76. Petitioner's placement of Amanda on the mother's abdomen and
rubbing Amanda's back immediately after delivery was contrary to
professionally recognized standards of health care for a newborn in
Amanda's condition. Id.
77. The RT's independent actions (Finding 74) were proper and
appropriate. Id.
78. Out of a possible total of "10," Amanda's Apgar score remained
a "2" at 1 minute, 5 minutes, and 10 minutes after birth. Tr. at
129 - 30, 290 - 91.
79. Apgar scores measure various functions of the baby
-- such as heart rate, breathing, and reflexes -- in five
categories. Tr. at 290 - 01.
80. A healthy baby's Apgar score at one minute after birth is
typically "8;" at 5 minutes after birth the typical score for a
healthy baby is "9;" and Apgar scores are not taken at 10 minutes
after birth for healthy babies. Tr. at 291.
81. Amanda's Apgar score of "2" at even 10 minutes after birth
indicated that her coloring remained poor, her respiratory effort
remained absent, her neurotone remained absent, and she remained
unresponsive to stimulation; she received points only for her heart
rate. Tr. at 130.
82. There is no credible evidence supporting Petitioner's
contention that someone told her Amanda's Apgar score had increased
to "4" at 5 minutes after birth. See Tr. at 341 - 42, 496 - 97.
83. There is no credible evidence supporting Petitioner's
additional contention that Amanda's Apgar score at 10 minutes was
"more like 10 instead of 2." See I.G. Ex. 4 at 1.
84. During the evening of Amanda's birth, Petitioner did not
request or accept consultation by another physician, and she
repeatedly rejected the suggestion of the nurses and the RT to
transfer Amanda to a tertiary care hospital. I.G. Ex. 1 at 3; Tr.
at 368, 430 - 34, 517, 525 - 26.
85. Contrary to professionally recognized standards of health
care, Petitioner viewed Amanda as a healthy infant in need of only
mouth to mouth resuscitation, or having air forced into her lungs,
in order to get well. I.G. Ex. 22 at 1; Tr. at 517 - 18; Findings
77 - 83.
86. In accordance with professionally recognized standards of
health care, Petitioner should have transferred Amanda to a
tertiary care facility as soon as possible, because Amanda was
experiencing severe respiratory problems and had an Apgar score of
"2" at 10 minutes after birth. Tr. at 142, 192, 297.
87. Dr. Henderson believed also that Petitioner should have
transferred Amanda shortly after Amanda's birth, and most doctors
practicing at Anderson County Hospital would have agreed with that
opinion. Tr. at 419.
88. In accordance with professionally recognized standards of
health care, a physician in Petitioner's situation should have
called at least for a pediatric consultation when a newborn's Apgar
score remained at "2" at 10 minutes after birth. Tr. at 142.
89. Petitioner's refusal to accept consultation or transfer Amanda
to a tertiary care unit, along with her failure to recognize the
seriousness of Amanda's condition, continued to place Amanda
unnecessarily in a high-risk situation. Findings 77 - 78.
90. After 63 minutes of aggressive treatment, Amanda's coloring
turned from blue to "pink with acrocyanosis," and Amanda began to
have some spontaneous movement. P. Ex. 8 at 1 - 2.
91. Even though Amanda was breathing by 7:05 p.m. on May 19, 1991,
she was doing so with tremors, crackles, grunting, cat-like crying,
and coarse sounds. I.G. Ex. 1 at 48 - 49.
92. Petitioner did not order a chest x-ray for Amanda until the
following day, despite Amanda's obvious breathing difficulties.
I.G. Ex. 14 at 46.
93. Petitioner did not order any diagnostic tests for Amanda. Tr.
at 142 - 50.
94. Petitioner considers all babies healthy and, for that reason,
did not view Amanda as being in need of diagnostic tests or
extraordinary intervention. Tr. at 503 - 06.
95. In accordance with professionally recognized standards of
health care, Petitioner should have ordered ABG (arterial blood
gas) tests; ABGs are necessary because a physical examination
cannot reveal the acidosis or carbon dioxide level in a baby's
blood. Tr. at 142 - 44, 299 - 300.
96. In accordance with professionally recognized standards of
health care, Petitioner should have ordered blood sugar level
studies for Amanda because, with stress, an infant can become
hypoglycemic -- i.e., suffer symptoms similar to a cardiac arrest
-- and there is no clinical sign that a physician can use in place
of a blood test. Tr. at 144 - 46, 355 - 56.
97. In accordance with professionally recognized standards of
health care, Petitioner should have ordered culture studies in
anticipation of possible infections and to help determine possible
causes for Amanda's respiratory condition. Tr. at 150, 302, 356.
98. In accordance with professionally recognized standards of
health care, Petitioner should have started Amanda on risk-free
prophylactic antibiotics as a matter of course, because time is
critical in the care of newborns and the results of the cultures
for infection may not be known for up to 72 hours. Tr. at 150 -
51, 303.
99. Petitioner's failure to order ABGs, blood sugar evaluations,
culture studies, or prophylactic antibiotics for Amanda has nothing
to do with the unavailability of diagnostic testing capability in
the delivery room of Anderson County Hospital or the hospital's
inability to provide results to a physician in less than 20
minutes. Finding 93; Tr. at 513.
100. At approximately 7:00 p.m. on May 19, 1991, the oxygen
saturation level of Amanda's blood dropped to 85 percent and
continued to decrease because, on Petitioner's order, the RT
removed the endotracheal tube from Amanda. Tr. at 146.
101. In accordance with professionally recognized standards of
health care, Petitioner should have initiated intensive treatment
and closely monitored the oxygen flow in order to bring the baby's
oxygen saturation up to the clinically acceptable range of 92 to 95
percent. Tr. at 147 - 49, 298 - 99.
102. With Amanda's low oxygen saturation level of about 80
percent, Petitioner placed Amanda unnecessarily at high risk for
brain damage and related complications by carrying Amanda to the
nursery without oxygen, by ordering routine care for Amanda on a
form sheet, and by allowing Amanda to be taken without oxygen to
the mother's room. Tr. at 151 - 52, 298 - 99, 304; I.G. Ex. 1 at
5.
103. Petitioner ordered oxygen "prn" (oxygen as needed) for
Amanda. Tr. at 300; I.G. Ex. 1 at 6.
104. Only 40 percent oxygen was started for Amanda in the warmer
after she was taken to the nursery with a low oxygen saturation
level of 82 percent, and Amanda's breathing was labored, with
crackling sounds throughout. P. Ex. 8 at 2; I.G. Ex. 1 at 48 - 49.
105. Amanda's oxygen saturation level was at 80 percent and 85
percent a few minutes before she was taken, without oxygen, to the
mother's room. I.G. Ex. 1 at 49.
106. Amanda's oxygen saturation level was at 85 percent when she
was returned to the nursery without oxygen. Id.
107. Amanda continued to have labored breathing and was given
oxygen intermittently for 20 hours at Anderson County Hospital.
I.G. Ex. 2 at 6.
108. In accordance with professionally recognized standards of
health care, Petitioner should not have delegated to the nurses or
RT the decisions of how much or how frequently oxygen should have
been given to a newborn with respiratory problems like Amanda's.
Tr. at 200, 300; I.G. Ex. 1 at 6.
109. In accordance with professionally recognized standards of
health care, Petitioner should not have ordered routine feeding for
Amanda in the nursery. Tr. at 301; I.G. Ex. 1 at 5.
110. Petitioner's ordering that Amanda be fed as a normal baby
placed Amanda unnecessarily at high risk for infarction of the
intestines (rupture of the gut) after Amanda had undergone great
and prolonged stress during and after delivery. Tr. at 301.
111. When Petitioner authorized Amanda's transfer to another
hospital more than 20 hours after her birth, Petitioner did not do
so voluntarily or for reasons she considered medically sound. I.G.
Ex. 1 at 4; Tr. at 443 - 45, 531.
112. Professionally recognized standards of health care require
proper and complete documentation by the physician, including a
history and physical evaluation of the patient, progress notes, and
a delivery note in an obstetrics case. Tr. at 201, 204.
113. The purpose of good documentation is to establish sound
communication between various health practitioners caring for the
same patient and to help the physician recall details about the
patient's condition. Tr. at 204.
114. Petitioner concedes that her records relating to Amanda are
inadequate. See P. Proposed Findings of Fact at 11.
115. Petitioner's inadequate documentation in Amanda's case is an
additional example of how she placed Amanda's health unnecessarily
at risk; Petitioner's insufficient documentation is consistent with
the conclusion that Petitioner's treatment of Amanda failed to
satisfy the professionally recognized standards of health care.
Findings 110 - 12.
116. Even though it is possible that Amanda may have suffered from
genetic defects, prenatal injuries, or epilepsy of unknown origin
at birth, Petitioner did not suspect such possibilities on May 19
to 20, 1991, when she cared for Amanda by viewing her as a healthy
newborn. P. Exs. 8, 10, 17 - 19; Tr. at 471 - 72, 501 - 09.
117. There is no evidence that a newborn with genetic impairments,
prenatal injuries, or epilepsy of unknown origin would have been
impervious to the health risks created by Petitioner in her care of
Amanda.
118. There is no evidence that Petitioner's treatment of Amanda
satisfied professionally recognized standards of health care for a
newborn with genetic impairments, prenatal injuries, or epilepsy of
unknown origin.
119. Given that the definition of "gross and flagrant" violation
does not require proof of actual damage to the patient, the I.G.
has satisfied her burden of showing that Petitioner grossly and
flagrantly violated her obligations under the Act in her treatment
of Amanda. Findings 47 - 116.
Petitioner's inability or unwillingness to comply substantially
with her professional obligations
120. Petitioner's treatment of Amanda demonstrates her inability
to comply substantially with her obligation to provide health care
of a quality that meets professionally recognized standards.
Findings 1 - 118.
121. Petitioner's recent justification of her omissions in her
care of Amanda demonstrate a continuing unwillingness to comply
substantially with her professional obligations. E.g., Tr. at 501
- 07; Findings 68, 73, 93.
122. Petitioner's placement of fault on the RT, Amanda's possible
genetic defect, Amanda's mother's allegedly deficient prenatal
care, and the alleged limitations at Anderson County Hospital also
demonstrate Petitioner's inability or unwillingness to comply
substantially with her professional obligations. P. Br. at 5 - 20.
123. For several years before Petitioner treated Amanda, the PRO
had attempted to correct quality of care problems in at least 13
other patients' cases that reflected Petitioner's non-current
medical knowledge base, non-standard or unusual practices, and lack
of familiarity with commonly used diagnostic techniques and
procedures. I.G. Exs. 16, 29 - 41.
124. Since 1987, the PRO has done intensified reviews of the care
Petitioner rendered to Medicare patients due to patterns of quality
problems. I.G. Ex. 16 at 3; I.G. Ex. 38 at 6; I.G. Ex. 41; Tr. at
30.
125. Petitioner has completed at least two CAPs (corrective action
plans) to date. Tr. at 34 - 36, 93 - 96.
126. At the time she cared for Amanda, Petitioner was nearing the
end of a six-month long CAP (either her second or third one). Id.
127. At the time Petitioner cared for Amanda, Dr. Henderson was
proctoring the treatment she provided to her Medicare patients
under the CAP then in effect. Tr. at 80 - 81.
128. Dr. Henderson was not proctoring Petitioner's treatment of
Amanda, because Amanda was a Medicaid recipient and, therefore, not
within the purview of the CAP. Tr. at 80 - 81.
129. Petitioner denies that she needs additional training in any
area of her current practice because she has not been notified of
any deficiency in her care during the past two and one half years.
Tr. at 585.
130. Petitioner has provided no credible evidence in support of
her allegation that she has been complying with her obligations
under section 1156(a)(2) of the Act during the past two and one
half years. See Tr. at 585; e.g., Findings 118 - 26.
131. During the past two and one half years, the PRO (and later
the I.G.) was moving toward having Petitioner remedy her practices
or be excluded from the Medicare and Medicaid programs. E.g., I.G.
Exs. 3 - 27.
132. At hearing, Petitioner expressed her satisfaction with the
care she provided to Amanda and the other 13 patients by describing
it as "good care" with "good results." Tr. at 562.
133. Petitioner's defense of the care she provided to the 13
patients does not differ significantly from her explanations to the
PRO several years before. Tr. at 558 - 76; I.G. Exs. 16, 29 - 41.
134. Petitioner's unwillingness or inability to comply
substantially with her professional obligations is demonstrated
further by: problems in her care of the other 13 patients; the
continuing quality problems she has exhibited despite the PRO's
efforts to have her remedy them; her current inability to recognize
deficiencies in her care of those 13 patients; her unwillingness to
take responsibility for the problems in her care of the 13
patients; and her continuous insistence that she provided good care
to those patients. E.g., Findings 129 - 131.
135. Petitioner defines a "gross and flagrant" violation of her
obligation under section 1156(a)(2) of the Act as "you don't give
a darn." Tr. at 576 - 77.
136. Petitioner believes that no finding of "gross and flagrant"
violation can be made in this case because she did "give a darn"
about Amanda. Tr. at 576 - 77.
137. Petitioner's interpretation of her professional obligation
does not assure that she will not be placing patients' lives and
health unnecessarily at high risk. Findings 133, 134.
138. Approximately six months prior to Amanda's birth, Petitioner
had attended a continuing medical education course in emergency
cardiopulmonary resuscitation involving neonates. Tr. at 469 - 70.
139. During 1993, Petitioner completed the 50 hours of continuing
medical education required for licensure in the State of Kansas.
Tr. at 583 - 84.
140. Petitioner believes she has taken twice as many hours of
continuing medical education classes as required by the State. Tr.
at 469.
141. Petitioner was unable to cogently describe the details of any
continuing medical education classes she has taken. Tr. at 583 -
84; see also Tr. at 469 - 70.
142. Petitioner's unwillingness or inability at present to comply
substantially with professionally recognized standards of health
care is demonstrated also by Petitioner's inability to describe any
continuing medical education class she has taken and her denial
that she needs additional training in any area of her current
practice. Findings 128, 137 - 40.
143. After noting the quality of care problem in Amanda's case,
the PRO proposed two alternative CAPs: that Petitioner enter a
mini-residency program of at least six months in duration, or that
she enter a program in Colorado for the period necessary to
evaluate and remedy her educational needs. Tr. at 40, 552; I.G.
Ex. 16.
144. The purpose of these two proposed CAPs was to help improve
Petitioner's knowledge base so that she might provide care of a
quality consistent with the requirements of the Act. Id.
145. Petitioner rejected both proposed CAPs because she wanted to
maintain her practice in Garnett and believed that either proposed
option would "eliminate" her practice or put her "out of business."
See Tr. at 547 - 52.
146. Petitioner offered to take more continuing medical education
classes or to have Dr. Henderson proctor her hospital admissions
once again. Tr. at 581.
147. Given the number of continuing medical education classes
Petitioner had taken when the patient care problems arose, her
inability to cogently describe any of those classes, and her denial
that she needs training in any area of her practice, Petitioner's
taking more classes will not substantially improve the quality of
her practice. Findings 128 - 41.
148. There is inadequate support for Petitioner's contention that
no significant violations of Petitioner's professional obligations
will recur if she is proctored by another physician. See, e.g.,
Findings 124 - 26.
149. Petitioner's rejection of the proposed CAPs in order to
maintain her medical practice and the futility of her alternative
proposals demonstrate her unwillingness to comply substantially
with her professional obligations. Findings 142 - 47.
150. The preponderance of the evidence supports the I.G.'s
determination that Petitioner was unwilling or unable to comply
substantially with her obligation to provide care of a quality
consistent with professionally recognized standards. Findings 119
- 48.
The reasonableness of the exclusion period
151. Petitioner has not voluntarily given up any area of her
medical practice. Tr. at 584 - 85.
152. The PRO recommended an exclusion of 10 years. I.G. Ex. 16 at
9.
153. The I.G. imposed and directed an exclusion of only three
years. I.G. Ex. 25 at 3.
154. An exclusion imposed under section 1156 of the Act is
intended to protect the welfare of program beneficiaries and
recipients from parties who are untrustworthy to provide heath care
of the requisite quality.
155. Petitioner's untrustworthiness has been shown by evidence
that establishes her unwillingness or inability to comply with her
professional obligations under the Act. Findings 47 - 148.
156. The totality of evidence, including Petitioner's
intransigence, inability to recognize problems in her treatment of
patients, and unreasonable defense of her personal pattern of
practice, demonstrate a strong likelihood that Petitioner will
again place Medicare beneficiaries and Medicaid recipients
unnecessarily at high risk. Findings 68, 94, 119 - 49.
157. The three-year exclusion is reasonable given the extent and
duration of the quality of care problems in the present record,
Petitioner's persistent unwillingness or inability to comply
substantially with professionally recognized standards,
Petitioner's reasons for rejecting the CAPs proposed by the PRO,
together with the other factors considered by the I.G. I.G. Ex. 25
at 4.
158. The three-year exclusion is reasonable also in light of
Petitioner's effectiveness in providing understanding and
compassion to patients; her willingness to see patients at
locations convenient to them; her concern for the nonmedical needs
of her elderly patients; her commitment to the people of her
community for more than four decades; her good intentions; and the
limited number of physicians currently practicing in Garnett. See,
e.g., I.G. Ex. 17; P. letter dated January 3, 1994; Tr. 448 - 49.
159. Even if it were true that Petitioner provides treatment to
Medicare and Medicaid patients at lower cost than other local
physicians, I cannot allow her to remain in the programs to provide
health care which is unlikely to be of the quality specified by
law. P. letter dated January 3, 1994; section 1156(b)(1) of the
Act.
160. The possibility that Amanda may have genetic defects or
suffered from prenatal injuries carries no weight for countering
the reasonableness of an exclusion imposed for the purpose of
protecting program beneficiaries and recipients from being placed
unnecessarily at high risk by the acts or omissions of their
physician. I.G. Ex. 25 at 4.
161. Because half of Petitioner's active charts are of Medicare
and Medicaid patients, it is likely that the exclusion will cause
Petitioner to cut back her practice by 50 percent. See Tr. at 580.
162. The three-year exclusion will provide Petitioner with the
time and opportunity to undertake the types of improvements she
needs. Finding 160.
163. The I.G. has proven by a preponderance of the evidence that
an exclusion of three years is reasonable. Findings 1 - 161.
ANALYSIS
Section 1156(a) of the Act imposes three professional obligations
on individuals who provide items or services to program
beneficiaries and recipients. One such requirement is that the
health care provided to program beneficiaries and recipients
will be of a quality which meets professionally recognized
standards of health care[.]
A PRO may recommend to the I.G. that an individual be excluded if
it determines that the individual has either failed in a
substantial number of cases to comply substantially with a
professional obligation, or if the individual has grossly and
flagrantly violated any obligation in one or more instances.
Section 1156(b)(1) of the Act.
The Act also specifies the responsibilities to be undertaken by the
I.G. (as the Secretary's delegate) in the sanction process. The
factors the I.G. must consider are identified by regulation. 42
C.F.R. 1004.90(d).
Section 1156(b)(4) of the Act entitles an excluded health care
practitioner to a hearing as provided by section 205(b) of the Act.
My obligation in conducting a hearing under sections 205(b) and
1156(b)(1) of the Act is to decide Petitioner's case de novo.
I. The I.G. applied the appropriate standard of professionally
recognized health care in the present case.
The exclusion in issue resulted from the I.G.'s agreeing with the
PRO that, when Petitioner treated an infant Medicaid recipient
named Amanda, Petitioner grossly and flagrantly violated her
obligation to provide services of a quality which meets
professionally recognized standards of health care. Petitioner had
delivered Amanda and cared for her at Anderson County Hospital in
Garnett, Kansas, from Amanda's birth at 5:44 p.m. on May 19, 1991
until 7:00 p.m. on May 20, 1991, when Amanda was taken by a mobile
transport unit to the University of Kansas Hospital in Kansas City.
I.G. Exs. 1 at 2; 2 at 4.
Garnett is a rural community of about 3200 people, and it is
located in a county having a population of approximately 7000
people. Tr. at 413 - 14. Petitioner has had a general medical and
surgical practice in Garnett for approximately 45 years. Tr. at
469. Even though Petitioner had delivered nearly 4000 babies to
date, she had not delivered many babies in the years preceding
Amanda's birth, due to the older age of her patients. I.G. Ex. 14
at 47, 66; Tr. 554.
In 1991, when Amanda was born, there were only two physicians, Dr.
David Henderson and Petitioner, who were practicing obstetrical
medicine in Garnett and Anderson County Hospital. Tr. at 397. Dr.
Henderson's involvement with Amanda's delivery was as the
hospital's chief of staff. See Tr. at 446 - 47. Petitioner was
the chief of the obstetrical department at the hospital at the time
she delivered Amanda. Tr. at 371. A malpractice suit filed on
behalf of Amanda is pending against both of them. Tr. at 446 - 47.
In opposing the I.G.'s basis for excluding her from participation
in the Medicare and Medicaid programs, Petitioner argued as a
threshold matter that the I.G. applied the incorrect standard in
deciding that she grossly and flagrantly violated standards of
professional care in treating Amanda. P. Br. at 5. Petitioner
reasoned that the standards of care in Petitioner's local community
should have been considered in determining whether Petitioner's
treatment of Amanda constituted a "gross and flagrant" violation of
the local "professionally recognized standards of health care"
contemplated by section 1156(a) of the Act. P. Br. at 5, 8 - 9.
Petitioner raised this contention as an affirmative defense to the
serious risk issue as well as to the ultimate issue of whether she
should be excluded at all under section 1156 of the Act.
There is no dispute that neither the PRO nor the I.G. had ever
inspected Garnett or Anderson County Hospital, and neither had
attempted to develop or apply any professional criteria unique to
that town or that hospital. E.g., Tr. at 45 - 46, 161; P. Br. at
7. The I.G. contends that the PRO acted consistently with the
regulation at 42 C.F.R. 466.100(d) and that, under the facts of
this case, there is no basis for establishing criteria unique to
Anderson County Hospital or Garnett, Kansas. I.G. Br. at 4 - 8.
Previously, I considered the parties' arguments on the applicable
standards of professionally recognized care in the context of the
"serious risk" issue. Under my authority to conduct a de novo
hearing on all relevant matters, I found that the professional
standards applied by the I.G. and the PRO were appropriate even
though the PRO had not specifically assessed the conditions in
Garnett or Anderson County Hospital. My full analysis of the
standard of care issue is contained in my "Ruling Finding Serious
Risk," at 4 - 11.
Since receiving my "Ruling Finding Serious Risk," Petitioner has
not urged me to reconsider my conclusions on the applicable
standard of care. However, Petitioner has not withdrawn the legal
arguments she made in her briefs addressing issues other than
"serious risk." It is therefore necessary for me to make formal
findings on the appropriate standard of care in deciding whether
gross and flagrant violations have occurred.
In assessing whether Petitioner grossly and flagrantly violated her
obligations under section 1156(b)(2) of the Act, I find that
Petitioner has not proven that the PRO abused its discretion under
42 C.F.R. 466.100(d), and, moreover, the general statewide
standards used by the PRO and the I.G. are consistent with the
regulations. See 42 C.F.R. 1001.2, 466.100(d); 50 Fed. Reg.
15,337 (1985) 5/; see also Tr. at 46 - 47. I make these findings
for many of those reasons already set forth in my "Ruling Finding
Serious Risk." The "serious risk" question is logically related
to
the I.G.'s basis for imposing the exclusion at issue, and the
relevant regulations are the same for both issues.
I continue to construe the term "standards" in section 1156(a)(2)
of the Act as necessarily denoting a level of knowledge and ensuing
quality of patient care below which no physician may fall. I found
especially persuasive the testimony of Dr. Hal Copple, an expert
witness called by the I.G. 6/, who noted that every physician must
meet certain minimum standards in order to do the best they can
with what they have available in order to meet the needs of
patients. Tr. at 285. As further indicated by the testimony of
Dr. James Allen, the PRO's medical director when it reviewed
Amanda's case, the "standard" applied by the PRO requires a
physician to possess common medical knowledge of a sufficiently
current nature that will enable the doctor to treat patients
safely. See Tr. at 39, 42. 7/
There is no dispute among the experts that hospitals may have
different equipment and different levels of technological
capabilities. Testifying for Petitioner, Dr. David Henderson
observed that different hospital settings may affect a physician's
ability to do "things" for her patients. See Tr. at 390 - 91.
However, as even Petitioner acknowledged:
I wasn't trained in the day when you automatically think of
doing a bunch of -- I mean in order to make a diagnosis, you got to
think of it. In order to order a test, you got to think of it.
I.G. Ex. 14 at 47.
I find inapposite Petitioner's contention that "[a] standard of
care practiced in one geographical area may place a beneficiary at
risk, but that same care may not elsewhere." P. Br. at 5. The
factual context of the present case does not give rise to any
legitimate issue of a physician's need to make reasonable
adjustments in her manner of practice due to geographical
constraints or the limitations of a hospital's resources in order
to safeguard her patients' health or safety from undue risks. I
have found no effort by the PRO or the I.G. to hold Petitioner to
a standard of expertise applicable to medical specialists or to
physicians practicing in large urban hospitals with state of the
art equipment. See, e.g., Tr. at 350 - 51. Nor has Petitioner
shown that she would have cared for Amanda in a different manner if
Amanda had been born in a different hospital outside of Garnett.
See, e.g., Tr. at 501 - 09.
The PRO applied statewide standards of care. Tr. at 46 - 47.
Given that Kansas has many small rural towns, I inferred that the
PRO's statewide standards encompass the reasonable features of
medical practices in small rural communities. Dr. Schwarting, for
example, who reviews patient charts for the PRO and who testified
for the I.G. at hearing, noted that he practices in a rural Kansas
town of 7500 people and at a rural hospital with a census of only
six to eight patients per day. Tr. at 125, 175.
There has been no effort by the PRO or the I.G. to equate the
resources of Anderson County Hospital with those of a tertiary care
center. The I.G.'s complaint seems to be Petitioner's
underutilization of common and available medical resources. The
I.G.'s position on this point is reflected in the opinions of Drs.
Richard Granville and Stephen Mawn of the Armed Forces Institute of
Pathology, Department of the Army, who wrote the I.G. as follows
concerning their assessment of the treatment provided by Petitioner
to Amanda:
[W]e are particularly struck by the paucity of even the most
basic medical technology for the benefit of this sick infant. In
this era of overly aggressive treatment and excessive use of
testing, it is interesting to note that there may be something
worse.
I.G. Ex. 21 at 2.
Here, the evidence does not permit me to find that a local standard
of care exists because Petitioner lacked the external resources
necessary for assessing and treating Amanda in the manner deemed
proper by the PRO. The very opposite has been shown by the
evidence. See Tr. at 203 - 04. For example, the I.G. established
the availability of a fetalscope or a Doppler that could have been
used by Petitioner to listen to the fetal heartbeat after there
were signs of fetal distress, and even though a fetal monitor was
not a necessity in the protocol described by the PRO, Dr.
Henderson's testimony established its presence in the delivery room
at Anderson County Hospital. Id.; Tr. at 406, 452. A delee
catheter was also available at Anderson County Hospital for
Petitioner to use in performing the simple suctioning procedure
described by the I.G.'s witnesses. Tr. at 437. Oxygen and a
trained respiratory therapist were available throughout the period
that the baby exhibited signs of distress in utero and was later
born respiratorily depressed. Tr. at 203; I.G. Ex. 1 at 17 - 20,
45 - 49. A telephone was available for Petitioner to use to seek
consultations from specialists or other physicians for Amanda's
care. When it became appropriate to transfer Amanda out of
Anderson County Hospital, a telephone was available for Petitioner
to use in arranging for the transfer to a nearby tertiary care
facility such as the University Of Kansas Medical Center. Tr. at
203 - 04.
The physician's obligation to deliver a quality of care
commensurate with a "professionally recognized standard of care"
exists for the benefit of patients. If local doctors and hospital
staff lack the knowledge to treat newborns like Amanda competently
and safely, then their lack of knowledge and ensuing actions cannot
be used to set any professional standard cognizable under section
1156(a)(2) of the Act. A physician also should have the judgment
and knowledge to refrain from retaining patients whose conditions
become more complicated than he or she is capable of treating
competently and safely. See Tr. at 357. A physician can refer
patients to specialists practicing elsewhere or have patients
transferred to other hospitals. Therefore, whatever the
limitations of Anderson County Hospital or other practitioners in
Garnett, Petitioner cannot now allege their inadequacies as a
defense after having decided to keep Amanda there for nearly 26
hours. See, e.g., Tr. at 289 - 90; I.G. Exs. 1 at 3; 2 at 4.
Petitioner is responsible for the state of her own knowledge and
the judgment calls she makes in the course of treating her
patients.
The regulation permits the PRO to deviate from statewide standards.
42 C.F.R. 1001.2, 466.100(c), and 466.100(d) ("A PRO may
establish specific criteria and standards to be applied to certain
locations and facilities . . . .") The PRO may exercise such
discretion only if there exists a substantial difference in the
local pattern of practice from the remainder of the PRO area, and
there is "a reasonable basis for the difference which makes the
variation appropriate." 42 C.F.R. 466.100(d). Petitioner has
not shown that the PRO abused its discretion because she has failed
to prove that either requirement has been satisfied in this case.
Petitioner has shown no relevant pattern of practice in Garnett or
Anderson County Hospital that is substantially different from what
exists in the rest of Kansas. In fact, it is doubtful that there
exists a discernible pattern of practice in Petitioner's local
area. I infer from Petitioner's testimony and certain findings
proposed by Petitioner that she believes she has developed her own
professional standards of practice over the years, and, therefore,
she could not have violated section 1156(a)(2) of the Act when her
actions or omissions conformed to her usual quality of care. See,
e.g., P. Proposed Findings of Fact at 7 (# 42: "Petitioner does
not, as a professional standard of care, routinely perform
diagnostic testing."); see also Tr. at 484. Petitioner testified
that the manner in which she delivered Amanda reflected her
"standard of care." Tr. at 484. Using Petitioner's own disputed
practices as the local standard is patently unreasonable and would
render section 1156 of the Act a nullity.
Nor was I persuaded to embrace Petitioner's view of a local
practice standard because she was chief of the obstetrical
department at Anderson County Hospital. See Tr. at 371. Dr.
Henderson testified that department chairmanships do not connote
superior accomplishments, training, or expertise. See Tr. at 461.
The positions are given to whichever doctor on the medical staff
will take them. Id.
In addition, Anderson County Hospital itself has imposed higher
standards of professional care on its physicians on staff than that
which Petitioner has sought to attribute to the hospital. See P.
Br. at 28. The evidence shows the hospital's disagreement with
Petitioner's contention that her delivery of Amanda was consistent
with the professional standards of care in existence at that
hospital. After Amanda's birth, Petitioner's obstetrical
privileges at Anderson County Hospital were suspended by the
hospital. Tr. at 407 - 10. Petitioner's privileges were restored
by vote of the five-member medical staff that included Petitioner,
Petitioner's husband, and Dr. Henderson -- all three of whom were
allowed to vote on Petitioner's application for reinstatement of
her privileges, despite their obvious personal bias or involvement
with Amanda's case. Id. However, following this vote, the
hospital board suspended Petitioner's obstetrical privileges once
again. Id.
The evidence shows also that some of Anderson County Hospital's
professional employees were dissatisfied with the quality of
treatment provided by Petitioner to Amanda. 8/ For example, a
respiratory therapist physically removed Amanda from Petitioner in
order to administer the needed oxygen therapy and to avoid the
onset of other life-threatening complications for Amanda. See Tr.
at 487 - 88; P. Proposed Findings of Fact at 4 - 5. After
witnessing Amanda's delivery and care by Petitioner, both a nurse
and the respiratory therapist spoke to Dr. Henderson in his
capacity as chief of staff, to raise with him their quality of care
concerns. Tr. at 430, 433 - 34. The respiratory therapist, a
nurse, and administrators of the hospital all urged Petitioner to
transfer Amanda to a tertiary care hospital, a recommendation which
Petitioner resisted until she had no option left. Tr. at 443, 517,
533; I.G. Ex. 1 at 46. Those health care professionals who were
employed by Anderson County Hospital and who also cared for Amanda
viewed Amanda's condition with great concern, whereas Petitioner
repeatedly denigrated them for having allegedly "panicked." E.g.,
Tr. at 517 - 18, 531. I therefore find that the standards of care
perceived by the health care employees of Anderson County Hospital
are different from that which Petitioner attempts to attribute to
them.
Even Dr. Henderson, who had an incentive to give testimony fully
favorable to Petitioner, did not view Petitioner as having acted in
accord with the medical standards as he knew them at all times in
her treatment of Amanda. E.g., Tr. at 438, 439. Because he is
defending against in the same malpractice lawsuit as Petitioner
concerning his involvement in Amanda's case, I do not give great
weight to his opinion that she rendered a proper standard of care
"to the extent [he] was involved." Tr. at 450. However, he
testified also that, unlike Petitioner, he would have transferred
Amanda after delivery. Tr. at 419. He noted also that, if the
local medical staff were to vote on the matter in a peer review
setting, most would have voted to transfer Amanda to another
facility after delivery instead of keeping her at Anderson County
Hospital as Petitioner had done. Tr. at 419. Such opinions are in
accord with the conclusions the I.G. formed on the basis of a
statewide standard of care. Dr. Henderson's testimony does not
persuade me that there existed local standards as Petitioner
attempted to depict in her defense.
The opinions submitted by Petitioner's non-testifying experts on
the standard of care issue were ambiguous at best. For example,
Dr. Earl B. Gehrt's opinion was that Amanda's care "may be" typical
of what is given in hospitals the size of Anderson County Hospital
to babies in similar condition. P. Ex. 10 at 2. Moreover, Dr.
Gehrt's opinion remains unsound for implying that, as long as
physicians on staff at a small hospital practice in the same
deficient manner, they would have created a professional standard
they also meet. Applying Dr. Gehrt's rationale to the facts of the
present case would mean, for example, that Dr. Henderson and
Petitioner could never have deviated from the local professional
standards for obstetrical care in Garnett and Anderson County
Hospital during 1991 because they were setting the local standards
at that time as the only two doctors practicing obstetrics in
Garnett and Anderson County Hospital. Such an outcome would be
illogical and contrary to the purpose of section 1156 of the Act.
Another of Petitioner's non-testifying experts, Dr. Michael
Radetsky, formed an opinion on the basis of certain documents sent
to him by Petitioner's malpractice defense attorney. P. Ex. 8 at
1; P. Ex. 9. Even though he was of the opinion that Petitioner met
the standard of care recommended in medical literature and as
ordinarily used by physicians, Dr. Radetsky was not subject to
cross-examination, the documents he received from Petitioner's
malpractice attorney were not identified for the record, and one of
the I.G.'s witnesses was of the opinion that Dr. Radetsky had not
attended a delivery in many years. Tr. at 346. Therefore, I do
not find his conclusions persuasive.
I found the expert witnesses presented by the I.G. very well
qualified and more credible in their opinions. Each of the I.G.'s
witnesses explained his opinions cogently, with references to
specific evidence of record, and each articulated his opinions
consistently, even during rigorous cross-examination. I found very
persuasive Dr. Copple's explanation of how he approached the issue
of whether Petitioner had breached the professionally recognized
standards of health care in her treatment of Amanda:
Things change. Times change. So when I am asked to evaluate
by [the PRO] . . . I review it, and I say to myself, Is that
acceptable?
Could I see a doctor doing that? That is not necessarily the
way I would have done it, but can I see another doctor in another
place provide this kind of care? Because, you see, I am not one of
those doctors that says it has to be done my way, or any other way
is not right
. . . I don't feel that way. So I get a spectrum in my mind
of very appropriate care, a little marginal, but still acceptable
standard of care, barely outside, not quite meeting some minimal
standards that I have.
And then there are cases like this [Amanda's case] that are so
far out there, I just am astounded.
Tr. at 350 - 51. I conclude that the other experts called by the
I.G. used similar methods of evaluation because they reached
conclusions very similar to Dr. Copple's. The I.G. committed no
error in having relied on the application of such a standard.
II. The I.G. has established by a preponderance of the evidence
that Petitioner grossly and flagrantly violated her obligation to
provide treatment to Amanda that was of a quality that met
professionally recognized standards of health care.
I have allowed the parties the opportunity to offer evidence
concerning the sufficiency of the facts on which the PRO's
recommendation and the I.G.'s ultimate determination are based. As
already noted, the I.G.'s authority to exclude under section
1156(b)(1) is derived from the PRO's reviews and recommendations.
Therefore, in deciding the issue of whether the I.G. had a
statutory basis for the exclusion determination, I did not give
weight to any evidence presented by the I.G. that concerned
materials, conduct, or facts not reviewed by the PRO in formulating
its recommendation to the I.G. on the same issue. 9/ Also, I
considered the evidence offered by Petitioner to rebut the factual
basis for the PRO's determination and recommendation to the I.G.
A gross and flagrant violation of the obligation to provide health
care which meets professionally recognized standards must include
an element of either actual or potential harm to a patient. 42
C.F.R. 1004.1(b). Here, the PRO's recommendation to exclude
Petitioner was based on a single instance of a "gross and flagrant"
violation. I.G. Ex. 25 at 1. The I.G. agreed with the PRO that
the care Petitioner provided to Amanda deviated from the
professionally recognized standards of care in a number of ways
which were identified in the notice letter.
The evidence before me fully supports the I.G.'s conclusion that
Petitioner placed Amanda unnecessarily in a high-risk situation.
Amanda's care was very badly managed by Petitioner from beginning
to end. Out of deficient knowledge or stubbornness, Petitioner
provided grossly inappropriate and substandard medical care to an
almost moribund infant. Such a substandard quality of care placed
that infant's fragile life and health in even greater peril.
A. Petitioner placed Amanda's life and health in a high-risk
situation by failing or refusing to recognize the significance of
a significantly decreased fetal heart rate and heavy meconium
staining in the amniotic fluid, both of which are signs of fetal
distress.
Petitioner has persisted in her opinion that Amanda's mother had a
normal delivery and that Amanda was born a healthy infant. I.G.
Ex. 1; Tr. at 133, 503 - 04. I find that, except for Amanda's
having been born full-term, there was nothing normal or healthy
about Amanda's condition. The delivery occurred with significant
indications of fetal distress that were not recognized or addressed
by Petitioner, and Amanda was born barely alive. See Tr. at 273.
When Petitioner was called to Anderson County Hospital for the
delivery on May 19, 1991, she had not delivered many babies in the
years immediately preceding, because most of her patients were of
advanced age. I.G. Ex. 14 at 47, 66. In addition, Petitioner
chose not to ask the nursing staff why they were so concerned about
the delivery that they had called independently for a respiratory
therapist. Tr. at 474 - 76, 478. Petitioner was aware that the RT
does not come for routine deliveries, and Petitioner was aware also
that there was an unspecified "disagreement" between the nurse and
herself, which created an "electric charged situation" that began
prior to delivery. Tr. at 478, 495. Yet, as the physician in
charge, she never asked the nursing staff the reasons for their
concerns nor decided for herself whether an RT was needed.
At 5:06 p.m. on May 19, 1991, complications began to occur. After
Petitioner ruptured the fetal membrane, the amniotic fluid that
leaked was stained with heavy meconium. Tr. at 131, 485; I.G. Ex.
1 at 45. Petitioner later testified that meconium staining
indicated that the baby had moved her bowels. Tr. at 485.
Petitioner did not appear to have understood the significance of
the heavy meconium staining. She did not write down a diagnosis of
meconium aspiration. Tr. at 134 - 35. Both Dr. Schwarting and Dr.
Copple opined that Petitioner's failure to properly diagnose
meconium aspiration syndrome placed the baby unnecessarily at risk.
Tr. at 134 - 35, 284 - 85. I agree.
Meconium staining of the amniotic fluid is a sign of probable fetal
distress. Tr. at 131 - 32. Meconium aspiration requires very
aggressive treatment as early as possible because, when a physician
does not see it as a problem, the physician can delay providing the
types of treatment that can prevent the baby from getting into
distress or help the baby breathe normally and get off to a normal
start. Tr. at 135. The medical writings submitted by Petitioner
also establish the significance of meconium staining. See, e.g.,
P. Exs. 1 - 4. The studies submitted by Petitioner include
information that as many as 62 percent of neonates born through
meconium stained amniotic fluid subsequently suffered respiratory
distress, and up to 46 percent of neonates with meconium aspiration
syndrome reportedly died from the disorder. P. Ex. 2 at 1.
Therefore, Petitioner should have been alerted to make provisions
for something other than an uncomplicated delivery of a normal
baby. See Tr. at 133.
In addition, 24 minutes later (at 5:30 p.m., or 14 minutes before
birth), the fetal heart rate decreased from 136 to 64. Tr. at 131,
201; I.G. Ex. 1 at 17, 45. Mild fetal brachycardia (slowness of
heartbeat) is indicated by a heart rate of 100 to 90; severe fetal
brachycardia is indicated by a heart rate of less than 90. Tr. at
202. Amanda's fetal heart rate of 64 was indicative of very severe
problems. Petitioner ignored the significance of these signs. The
expert opinions from both parties show that the fetal heartbeat
should have been monitored for continued or additional signs of
distress. E.g., Tr. at 281; P. Ex. 3. Petitioner, however,
ordered the staff to stop monitoring the fetal heart rate even
though a fetal heart monitor was in the delivery room. 10/ I.G.
Ex. 1 at 17.
According to the RT, a nurse told Petitioner at the time Petitioner
gave her order to cease checking the fetal heart rate that such an
order was contrary to law. I.G. Ex. 1 at 17. During this period
of time, the RT remained outside the delivery room. Id. Because
Petitioner did not order any oxygen for Amanda's mother for 12
additional minutes, the fetal heart rate remained at 64 for that
period of time. Id.
Petitioner's failure to attribute significance to either the
meconium staining or the decreased fetal heart rate resulted in her
failure to initiate oxygen therapy promptly for the mother and
fetus. Dr. Schwarting noted that oxygen was unreasonably and
improperly withheld from the mother and fetus until just two
minutes before birth. Tr. at 201; I.G. Ex. 21 at 3. According to
Dr. Schwarting, two parameters should have indicated to Petitioner
that the fetus was in distress and needed oxygen: the thick
meconium staining and the decrease in fetal heart rate to 64. Tr.
at 201. There was an unnecessarily long delay in initiating oxygen
therapy. Petitioner could have and should have had oxygen flowing
to the mother and fetus at as early as 38 minutes before the birth.
Tr. at 201 - 02. When oxygen was finally given at two minutes
before birth, the fetal heart rate increased from 64 to 96. I.G.
Ex. 1 at 17.
Petitioner's inattention to potential problems is further evidenced
by her failure to ensure that the RT was inside the delivery room
and ready to render assistance. Dr. Schwarting and Dr. Copple both
described the responsibilities they would have given an RT in
anticipation of an infant experiencing respiratory problems. Tr.
at 131 - 32, 274, 287 - 88. By contrast, Petitioner did not give
the RT even any orders on being inside or outside the delivery room
for the birth. Tr. at 476.
Petitioner later attempted to persuade me that she was aware of the
risks and had considered the option of transferring Amanda's mother
to a tertiary care unit after the fetal heart rate dropped. She
contends that she did not attempt the transfer because she felt
"the baby would be out of the woods" by the time the transport team
arrived. Tr. at 508 - 09.
I find these post hoc assertions to be lacking in support and
irrelevant as a defense to Petitioner's failure to make provisions
at Anderson County Hospital for her delivery of a respiratorily
depressed baby. The absence of a diagnosis for meconium staining
syndrome, the order to discontinue monitoring the fetal heart tone,
and the undue delay in ordering oxygen therapy demonstrate
Petitioner's lack of awareness of any potential medical problems.
There is no persuasive evidence that Petitioner considered the
option of transferring Amanda's mother prior to delivery or that
Petitioner was justified in her belief that she could bring the
baby "out of the woods" after delivery. Given some of the opinions
she has expressed to the PRO, I find that on May 19, 1991,
Petitioner was giving effect to her strong preference for allowing
all babies (no matter in what state of health) to enter the world
naturally and in their own good time. I.G. Ex. 22 at 2.
Even more importantly, if Petitioner decided to keep Amanda's
mother at Anderson County Hospital and perform the delivery there,
then Petitioner should have made provisions for delivering an
unhealthy, very respiratorily depressed baby. Petitioner's
decision not to transfer Amanda's mother did not relieve her of her
obligations to treat Amanda competently and in accordance with
professionally recognized standards of health care.
B. Petitioner placed Amanda at high risk for inhaling meconium and
incurring related complications by failing to suction Amanda's
airways in a manner required by professionally recognized standards
of care.
Petitioner should have been aware from the medical literature she
submitted that the most important preventative measure a physician
can provide to a neonate with meconium aspiration syndrome is
careful, thorough catheter suctioning of secretions from the
oropharynx before the baby takes her first breath. P. Ex. 1 at 1
- 2; P. Ex. 2 at 5. According to the I.G.'s experts and the
medical literature introduced by Petitioner, the procedure called
"suctioning the baby on the perineum" has been widely used by
physicians for many years in deliveries like Amanda's. E.g., P.
Exs. 1 - 4; Tr. at 133, 275 - 82. The procedure involves the
physician's stopping the descent of the baby's head at the mother's
perineum (or bottom) during delivery in order to suction out the
meconium from the baby's upper respiratory tract while the baby is
still attached to the mother by the umbilical cord and before the
baby takes her first breath. Tr. at 132 - 33. The procedure takes
no more than 10 seconds to complete, and only in very rare
instances is the procedure precluded by the speed of the delivery.
Tr. at 280. Physicians use the procedure because it is safe for
mother and baby, it is done at the earliest presentation of the
baby's head, and there is no need for the baby to breathe while she
is still attached by the umbilical cord. Tr. at 132, 275 - 76,
283. Physicians suction the baby on the perineum to conserve
critical time and to reduce the risk of the baby's inhaling the
meconium in her airways.
Petitioner acknowledges that the delivery of Amanda took six
minutes. P. Proposed Findings of Fact at 3 (citing Tr. at 486,
498). She had earlier attempted to convey the misimpression to the
PRO that there was inadequate time to suction Amanda on the
perineum because the delivery took place "rather quickly." I.G.
Ex. 4 at 1. In fact, there was ample time for Petitioner to have
suctioned the baby on the perineum for the 10 seconds or less the
procedure usually takes. See Tr. at 280.
Suctioning the baby on the perineum was a procedure that a rural
practitioner should be familiar with and capable of performing.
Tr. at 133. There is no specialized equipment required. Tr. at
132 - 33. Dr. Henderson's testimony establishes that a delee
catheter, a simple suctioning instrument, was available at Anderson
County Hospital. Tr. at 437, 132 - 33. Dr. Henderson also agreed
that a prevailing standard was to suction a baby with heavy
meconium staining on the perineum. Tr. at 437. He does not know
why Petitioner did not suction the baby on the perineum. Tr. at
438 - 39.
Even after hearing the testimony from the I.G.'s experts concerning
the benefits of the procedure, Petitioner argued that suctioning
the baby on the perineum was not appropriate because she viewed the
procedure as the equivalent of hanging the baby by the neck and
with the potential for causing a "neck syndrome." Tr. at 484.
Petitioner doubted also the wisdom of slowing down the descent of
the baby's shoulders from the birth canal in order to suction the
baby while the baby is attached by the umbilical cord; Petitioner
asserted that "there would be more damage to the brain than you
would save in [the] lung." Tr. at 482. Petitioner based the
latter opinion on the small red marks (petechia) she has seen on
some infants' heads after delivery. Id.
I find Petitioner's concerns peculiar and unsubstantiated by the
medical evidence of record. Her objections to suctioning the baby
on the perineum supports Dr. Allen's conclusion on behalf of the
PRO and the I.G. that Petitioner's medical knowledge "is not of
sufficiently current character that she can provide reasonably
up-to-date care that meets currently recognized standards." Tr. at
39.
Having considered the totality of Dr. Henderson's testimony, I
reject Petitioner's contention that Dr. Henderson did not discern
any deviation from the applicable standards of care. See P. Br. at
28. Dr. Henderson did not state that as of 1991 he had never
suctioned a baby on the perineum. When asked about his experiences
with the procedure, Dr. Henderson testified that it was not done
very much at Anderson County Hospital and that the procedure is not
usually done in the deliveries he has witnessed with other
practitioners. Tr. at 451. This testimony must be viewed in the
context of Dr. Henderson's additional information that few
respiratorily depressed babies have been born at Anderson County
Hospital. Tr. at 450, 504 - 05. Therefore, Dr. Henderson's not
having seen many babies suctioned on the perineum is attributable
to the uncomplicated births of respiratorily healthy babies that
usually occur at Anderson County Hospital.
I find that Petitioner's delay of the suctioning until the baby was
fully delivered placed the baby unnecessarily in a high-risk
situation for inhaling meconium. Petitioner contends that the
difference between her actions and the procedure described by the
experts amounts to only split seconds. Tr. at 481. This
contention appears to be an exaggeration and does not eliminate the
issue of unnecessary risk to Amanda. Moreover, it does not take
more than a split second for a baby to begin inhaling. The
evidence persuades me that Petitioner suctioned Amanda after
delivery because Petitioner had not understood the signs of fetal
distress, was not familiar with suctioning the baby on the
perineum, had illogical fears of the procedure, and did not realize
the dangers she created for Amanda by delaying the suctioning.
I agree with Dr. Schwarting's opinion that, even by themselves,
Petitioner's failure to recognize and prepare for addressing
probable complications prior to delivery and Petitioner's failure
to suction Amanda on the perineum demonstrated a gross and flagrant
violation of her obligation to provide Amanda with health care of
a quality that met professionally recognized standards. See Tr. at
135 - 36.
C. Petitioner placed Amanda in a high-risk situation by failing or
refusing to recognize that Amanda was critically ill at birth, by
not properly managing the resuscitation efforts for Amanda shortly
after delivery, and by exposing Amanda to further life-threatening
complications, such as hypothermia.
Petitioner's mismanagement of Amanda's care did not end after
delivery. When Amanda was born at 5:44 p.m., she was flaccid, and
she did not cry. I.G. Ex. 1 at 45. Amanda's Apgar score 11/
remained a "2" at one minute, five minutes, and ten minutes after
birth. Tr. at 129 - 30. The typical score for a healthy baby at
one minute after birth is "8," and the typical score for a healthy
baby at five minutes after birth is "9;" Apgar scores are not
normally taken at 10 minutes after birth for healthy babies. Tr.
at 293. Amanda's score of "2" meant that "the only thing that
the
baby could get points for was the heart rate." Tr. at 130.
Despite Amanda's consistently poor Apgar score, Petitioner
testified at hearing that she considers all babies healthy and, for
that reason, she did not consider Amanda to have been in need of
diagnostic testing or extraordinary intervention. E.g., Tr. at 503
- 06.
I am appalled by the sworn statements of Petitioner that she viewed
all babies, including Amanda, as being healthy. Tr. at 503 - 06.
For more than one hour after her birth, Amanda remained flaccid,
cyanotic, blue in color, and unable to breathe on her own. P. Ex.
8 at 1 - 2. During the time Petitioner viewed Amanda as healthy,
Amanda was nearly dead. Petitioner was unable to treat Amanda
properly because Petitioner was unable or unwilling to recognize
Amanda's abnormalities and poor health.
Petitioner created unnecessary risks for Amanda immediately after
delivery by having placed Amanda on the mother's abdomen to rub the
baby's back. Tr. at 293 - 95. Petitioner gave no instructions to
the RT immediately following delivery. Instead, Petitioner laid
the baby on the mother's abdomen and rubbed the baby's back. Tr.
at 477 - 78, 487 - 88. The RT rushed into the delivery room on her
own initiative, physically removed the baby from Petitioner, placed
the baby on a warming tray, and began pumping oxygen into the baby.
Tr. at 487 - 89.
What the RT accomplished without Petitioner's orders was
appropriate because Amanda needed to be ventilated by mechanically
controlling her airways, Amanda needed to be placed on a secure and
well lit surface for the resuscitation treatments, and Amanda
needed to be in a warm environment to avoid the onset of further
life-threatening complications such as cold-stress. E.g., Tr. at
182, 185 - 87, 292 - 93, 295. Consistent with Petitioner's
contention that she believed Amanda was a healthy baby,
Petitioner's placing Amanda on her mother's abdomen reflected
Petitioner's failure to recognize that Amanda's airways needed
immediate and extensive ventilation, which could only be done on an
appropriate surface. Petitioner's approach immediately after
delivery wasted critical moments in Amanda's health and
development, risked doing damage to Amanda's central nervous system
and other organs, and exposed Amanda to the risk of hypothermia.
Tr. at 136 - 37, 140.
Even Dr. Gehrt, who did not take the stand, gave his written
opinion that Amanda was "critically ill" at the moment of delivery,
and "[m]aximum effort was needed to help the baby breathe and to
clear the lungs." P. Ex. 10 at 1. Dr. Gehrt observed that there
was no suctioning of the vocal cords noted, and he believed this
should have been done. Id. Even though he suggested that a
vigorous term baby can usually clear his own lungs (Amanda was a
critically ill term baby), Dr. Gehrt was of the opinion that Amanda
probably suffered an episode of injury after birth due to the
meconium and other amniotic fluid that had been in her lungs when
she tried to breath. 12/
D. Petitioner kept Amanda at Anderson County Hospital and did not
call for consultation by other physicians because, against signs to
the contrary, Petitioner thought Amanda was a normal, healthy
newborn.
Petitioner never sought the help of other physicians after
delivering Amanda, and she consistently rejected others'
suggestions that she take a more prudent course of action.
Petitioner should have been aware of the benefits of seeking help
from other physicians since, at the time she delivered Amanda, she
was still under a six-month long CAP (her second or third one)
required by the PRO. Tr. at 34 - 36, 93 - 94, 96. Under this CAP,
Dr. Henderson was proctoring Petitioner's treatment of all her
Medicare patients. Tr. at 80 - 81; I.G. Ex. 41 at 25 - 26. Dr.
Henderson was not required to oversee Petitioner's delivery of
Amanda under the CAP, only because Amanda and her mother were
Medicaid recipients. Id.
I agree with the opinion of the I.G.'s witnesses that, when
Amanda's Apgar score remained at "2" even 10 minutes after birth,
13/ Petitioner should have taken additional action, such as calling
for pediatric consultations or ordering that Amanda be transferred
to another hospital with physicians and personnel more capable of
treating respiratorily depressed newborns. Tr. at 142. Dr. Copple
noted the appropriateness of the latter option as soon as the
resuscitation efforts had been accomplished and it was apparent
that Amanda was barely alive. Tr. at 297 - 98. Transferring
Amanda would have been appropriate since Anderson County Hospital
has had little experience with such babies. Tr. at 450, 504 - 05.
Petitioner herself noted at hearing that the RT was not a
registered respiratory therapist. Tr. at 516. In spite of having
delivered 4000 babies since she began practicing, Petitioner had
not delivered many babies in the years preceding Amanda's birth.
I.G. Ex. 14 at 47, 66; Tr. at 554.
Ten minutes after Amanda was born, the RT and a nurse requested
that Amanda be transported to another hospital. I.G. Ex. 1 at 3;
Tr. at 517. Petitioner rejected that request. Id. Even at
hearing, Petitioner described the RT as having "panicked," like
"somebody yelling fire," while she saw herself as having maintained
"sense" by refusing to transfer Amanda out of Anderson County
Hospital, a facility she later associated with those local
circumstances that allegedly impacted on her professionally
recognized standards of care. Tr. at 517 - 18; I.G. Ex. 22 at 1;
P. Br. at 9 - 14. Petitioner thought that all Amanda needed to get
well was mouth to mouth resuscitation or to have air forced into
her lungs. I.G. Ex. 14 at 35; I.G. Ex. 22 at 1. I find
Petitioner's refusal to transfer Amanda or to seek consultation to
be a further reflection of her inability, failure, or refusal to
recognize the seriousness of Amanda's condition, which continued to
place Amanda unnecessarily in a high-risk situation.
Approximately 45 minutes after the delivery, Dr. Henderson was
called to the hospital in his capacity as the chief of staff -- but
not at Petitioner's request and not with her consent. Tr. at 366,
430 - 34, 525. 14/ Dr. Henderson looked at Amanda in the delivery
room for two minutes from a distance of two feet and heard her make
a "weak, squeaky, crying noise." Tr. at 367. Petitioner declined
his offer to stay and assist her. Tr. at 526. When he inquired if
she had considered transferring the baby to another facility, she
told him a transfer was not necessary. Tr. at 368. According to
Petitioner's later testimony, she did not see the need for a
transfer because she did not perceive the baby to be in ill health.
Tr. at 504. Dr. Henderson testified at hearing that he believed
Petitioner should have transferred the baby that evening. Tr. at
419. He thought she had done what she could have at Anderson
County Hospital by the time he departed from the hospital. Id.
Petitioner asked that I find fault with the RT's having absented
herself from the delivery room without Petitioner's permission
during a period when Petitioner allegedly needed her. P. Proposed
Findings of Fact at 5 - 6. According to Petitioner, shortly after
Amanda's birth, the RT left the delivery room for approximately 15
minutes without having first told Petitioner where she was going or
for how long. Tr. at 519 - 22. Petitioner stated that, during
this period, the RT was calling Dr. Henderson to ask that he
countermand Petitioner's decision to retain Amanda at Anderson
County Hospital. Tr. at 363 - 65, 520 - 21. Petitioner said she
needed the RT's assistance during the 15 minutes and, also, that
she personally removed the endotracheal tube from Amanda while the
RT was gone because Amanda was breathing well. Tr. at 521 - 22.
According to the RT, she left the delivery room to obtain a
pediatric probe because the oxygen saturation in Amanda's blood had
been at only 83 percent and her heart rate was at 118. I.G. Ex. 1
at 19. The RT noted in the records that she left directions for
the nurse to continue oxygen therapy in her absence, and while she
was out of the delivery room, she did ask that Dr. Henderson be
called. Id. When the RT returned with the pediatric probe,
Amanda's oxygen saturation was 87 percent and her heart rate was
128. Id. Amanda was still flaccid, unresponsive to stimuli or to
suctioning of her mouth and nose. Id. Green secretions were still
being aspirated. Id. There is no notation of the RT's awareness
that Petitioner had removed the infant's endotracheal tube during
the RT's absence from the delivery room or that the infant had been
breathing well spontaneously during those 15 minutes as alleged by
Petitioner. See Tr. at 521 - 22.
Even if Petitioner did not know why the RT had left the delivery
room, I agree with Dr. Schwarting's view that the physician in
charge cannot delegate the resuscitation of a newborn in severe
distress to a nurse or an RT. Tr. at 200 (testifying in response
to Petitioner's remarks that she assumed the RT was capable of
resuscitating the baby and had left the matter in the RT's hands).
Petitioner was supposed to have been in charge of Amanda's care and
in command of the support team.
Petitioner allowed the RT to do as she saw fit. Petitioner did not
order the RT to attend the delivery; she gave no order for the RT
to be either inside or outside the delivery room during delivery;
and, without orders from Petitioner, the RT rushed into the
delivery room to remove the baby from Petitioner in order to begin
resuscitation efforts on a warming tray. The RT's absence does not
excuse Petitioner's failure to manage Amanda's care appropriately
in her capacity as the attending physician. If Petitioner did not
want the RT to come and go from the delivery room as the RT had
been doing, then Petitioner should have ordered the RT to stay.
Petitioner could have given the RT specific orders on the
resuscitation therapy. Since Petitioner had been permitting the RT
to take independent actions without orders, the RT cannot be
faulted for leaving the delivery room at her own discretion for
purposes she believed appropriate.
E. Petitioner placed Amanda in a high-risk situation by having
failed to order appropriate tests or prophylactic antibiotics.
The evidence persuades me that Petitioner continued to perceive and
treat Amanda as if she had been born a normal, healthy infant when,
in fact, Amanda's moribund state had been reversed only through
vigorous artificial management of her airways for more than one
hour. Even Petitioner's own expert stated that it was after 63
minutes of aggressive treatment that Amanda's coloring turned from
blue to "pink with acrocyanosis" and Amanda began to have
spontaneous movement after having been born flaccid. P. Ex. 8 at
1 - 2. After Amanda began to breath on her own with an
endotracheal tube down her throat and her color improved,
Petitioner "just did not think of" any diagnostic tests to order.
Tr. at 514.
The nurse's notes are replete with observations that, even though
the baby was breathing by 7:05 p.m. on May 19, 1991, she was doing
so with "tremors," "crackles," "grunting," "cat-like
crying," and
with "coarse breath sounds" throughout. I.G. Ex. 1 at 48 - 49.
Yet Petitioner did not order a chest x-ray for Amanda until the
following day. I.G. Ex. 1 at 13. When asked by the PRO why she
did not order a chest x-ray until the next day in the face of these
obvious signs of respiratory difficulties, Petitioner's only answer
was "I guess I just didn't order it at that point." I.G. Ex. 14 at
46.
I find that Petitioner placed Amanda unnecessarily at risk by
having failed to order arterial blood gas (ABG) tests, culture
studies, blood sugar tests, or prophylactic antibiotics. ABG tests
are appropriate for infants born in Amanda's condition with an
Apgar score of "2" at 10 minutes because, even if her coloring had
improved later, a physical examination would not have revealed
significant acidosis or the carbon dioxide level in her blood. Tr.
at 143 - 44, 299. The blood sugar level test was appropriate for
Amanda also because, with stress, infants can frequently become
hypoglycemic, 15/ and there is no clinical sign a physician can use
as substitute for a blood test. Tr. at 144 - 46, 355 - 56.
Without the blood glucose results, a physician cannot know whether
treatment is needed. Tr. at 355.
With Amanda's having had the meconium in her airways and having
undergone the aggressive suctioning and related resuscitation
efforts during the first hour of her life, Petitioner should have
ordered culture studies in anticipation of possible infections.
Tr. at 149 - 50, 302, 356. Culture studies could have helped to
eliminate or confirm a possible cause of Amanda's respiratory
condition. See Tr. at 302. Petitioner should have started Amanda
on prophylactic antibiotics as a matter of course because time is
critical in the care of newborns, and the results of the cultures
for infection may not be known for up to 72 hours. Tr. at 150 -
51, 303. Prophylactic antibiotics offer no risk and could have
been given easily. Tr. at 151. Petitioner has offered no valid
evidence to contradict the need for the tests identified by the
I.G.'s experts.
Earlier, at a hearing before the PRO, Petitioner was unable to
respond to the PRO's repeated requests to identify those clinical
indicators that she looks for in deciding whether to order septic
workup, blood sugar tests, or other procedures for infants. I.G.
Ex. 14 at 69 - 71. Her answers were either evasive or inapposite,
and she could not identify the indicators even after a conference
with her attorney. Id. Her answer was merely that, if she thought
the child was in trouble and needed tests, she would transfer the
child elsewhere. Id. However, even after a conference with her
attorney, she could recall only one instance three years ago when
she transferred a child for suspected meningitis. Id. at 73. She
provided some examples of the indicators for sepsis only after a
PRO doctor gave away the answers in his question. Id. at 71 - 72.
16/
With regard to the blood tests, Petitioner had told the PRO that
she could have run blood gas and blood sugar tests, but, in her
opinion, they would not have made any difference in her treatment
of Amanda. I.G. Ex. 14 at 65. At hearing, upon being asked why
she had not obtained blood sugar readings for Amanda, Petitioner
said it was because she "[j]ust didn't think of it[,]" and "nobody
suggested it" to her. Tr. at 500. She noted also that if the RT
had thought any diagnostic testing should have been done, the RT
should have let Petitioner know, as Petitioner was relying on the
RT's assistance. Tr. at 513. I find the RT's thoughts to be
irrelevant to the standard of care to which Petitioner is held as
the physician in charge.
Petitioner has asked me to find that diagnostic testing could not
have been performed in the delivery room of Anderson County
Hospital, that testing would have taken more than 20 minutes to
perform, and that the RT was not surprised that Petitioner had not
ordered tests on the day of delivery. P. Proposed Findings of Fact
at 7. I conclude that these proposed findings, even if proven, are
irrelevant and unavailable as a defense to Petitioner. The experts
never contended that the tests needed to have been done in the
delivery room or in less than 20 minutes after Amanda's birth.
Moreover, Petitioner's reasons for failing to order the appropriate
tests had nothing to do with where or after what period of time the
tests could be performed. As for the RT's not being surprised by
the absence of any order for tests, I think it sufficient to remind
Petitioner that she is a physician, not an RT.
As a physician, Petitioner could articulate no medical reason for
her omissions other than her opinion that Amanda was a healthy,
normal newborn. E.g., Tr. at 504, 506. Petitioner repeatedly
testified at hearing that she believed Amanda was healthy and
needed no tests or antibiotics. Id. Such a clearly erroneous
opinion evidences the inadequate state of Petitioner's medical
knowledge that resulted in the gross and flagrant violation of the
professionally recognized standards of her care on May 19 and 20,
1991.
F. Petitioner placed Amanda in a high-risk situation by sending
her to the nursery with routine orders and failing to address
Amanda's hypoxia.
By about 7:00 p.m. on the evening of Amanda's birth, Amanda was
breathing only because she had been given more than one hour of
extraordinary intervention that included having had large amounts
of meconium suctioned out of her, having had air forced manually
into her lungs, and having had an endotracheal tube inserted in her
to ensure the continued flow of oxygen. E.g., Tr. at 514 - 15.
Approximately one hour and 15 minutes after Amanda's birth,
Petitioner ordered the RT to extubate the baby. Tr. at 146. The
RT was apparently so surprised by the order that she asked
Petitioner to repeat it. 17/ Id.
Five minutes after the RT removed the tube from the baby on
Petitioner's order, the oximetry 18/ reading showed that Amanda's
oxygen saturation level was at only 85 percent. Id. Fifteen
minutes after the baby was extubated, the oximetry reading had
dropped to 82 percent, which was considered very low and should
have caused Petitioner to order that intubation be resumed or that
other procedures be used to bring the baby's oxygen saturation up
to the clinically acceptable range of 92 to 95 percent. Tr. at 147
- 48, 299. Instead of heeding the oximetry readings, treating
Amanda intensively, and closely monitoring Amanda's oxygen input
and output, Petitioner took Amanda to the nursery in her arms
without oxygen and wrote routine orders on a form sheet as if
Amanda were a normal newborn. Tr. at 148 - 49, 273, 299.
Petitioner then allowed the baby to be taken out of the nursery to
the mother's room when the baby was already at risk due to a oxygen
saturation of 80 some percent and the need for continuous oxygen.
Tr. at 151 - 52. Dr. Schwarting noted that the mother could have
come to the nursery to view the baby, which would have eliminated
the added risk of hypothermia for an already unhealthy baby while
allowing the nursery staff to continue the monitoring for apnea in
a baby who was not yet breathing well. Tr. at 152. Dr. Copple
noted, too, that when Amanda's blood oxygen was low, there was less
oxygen going to her brain; therefore, it was inappropriate for
Petitioner to permit the baby to be taken out of the nursery. Tr.
at 304.
Petitioner's response to the above criticism was and continues to
be that she did not know the oxygen saturation was as low as 80
percent on room air when she authorized the baby to go to the
mother's room. See Tr. at 152, 505. Her inadequate documentation
pertained to Amanda's first 55 minutes of life, during which time
Petitioner believes she had "pretty much" continuously given Amanda
oxygen. Tr. at 499 - 500. One of Petitioner's experts found that
only 40 percent oxygen was started in the warmer after Amanda was
taken to the nursery at the 81st minute of her life, and Amanda's
breathing was labored with crackles throughout. P. Ex. 8 at 2.
After the first 113 minutes of life, supplemental oxygen was given
to Amanda only intermittently. Id. Petitioner's lack of concern
for Amanda's condition after the removal of the endotracheal tube
supports the conclusion that Petitioner grossly and flagrantly
violated her professional obligations to Amanda.
I accept Dr. Copple's opinion that Petitioner's ordering "[o]xygen,
go to PRN" (oxygen as necessary) for Amanda also was inappropriate.
Tr. at 300; I.G. Ex. 1 at 6. It is the responsibility of the
physician to determine when and how much oxygen is required by a
patient. Id. That responsibility cannot be and should not be
delegated to a nurse, especially where a newborn has been suffering
severe respiratory problems. Id.; see also Tr. at 200. I note
that Petitioner has asked for a finding that she "did not undermine
the resuscitation of Amanda" (P. Proposed Findings of Fact at 4),
which is clearly inapposite to the professionally recognized
standards applicable to physicians.
Petitioner created grave health risks for Amanda when she sent the
baby to the nursery with routine orders that she be fed as a normal
baby. See I.G. Ex. 1 at 5. According to Dr. Copple, no other
doctor would have risked having the Amanda fed after she had been
exposed to stress during delivery and for at least one hour after
delivery. Tr. at 301. Infarction of the intestines, or rupture of
the gut, could have occurred within hours of ingesting food or
water due to the blood flow to the intestines and the way the
newborn's body handles blood pressure after such stress. Id.
Petitioner did not refute Dr. Copple's opinion concerning possible
infarction of the intestines. Nor did she indicate any awareness
of that possibility when explaining her concern for Amanda's not
having tolerated the glucose water she had ordered on the second
day. Tr. at 531 - 32. (Earlier, Amanda had ingested glucose water
two or three times. I.G. Ex. 1 at 3.) Petitioner authorized
Amanda's transfer to another hospital only after Amanda failed to
drink fluids on the afternoon following her birth. Tr. at 531 -
32.
Even at hearing, Petitioner continued to imply that there was no
medical need for the transfer. She had described a report of
Amanda's deteriorating condition at Anderson County Hospital as a
"panic call" to her. Tr. at 531. Petitioner noted that she had
examined the baby and determined from an x-ray only that the lungs
had not fully expanded after delivery. Tr. at 530 - 31. She wrote
that Amanda's lungs were clearing but the nursing staff insisted on
a transfer. I.G. Ex. 1 at 4.
I find that, even in ultimately transferring Amanda, Petitioner did
not exhibit any knowledge or judgment commensurate with
professionally recognized standards. She signed the transfer
papers only because she knew that the hospital administrator was
prepared to effectuate a transfer without her consent. Tr. at 533.
Dr. Henderson confirmed that, earlier in the afternoon of May 20,
1991, the head of the hospital had already met with Dr. Henderson
in his capacity as the chief of staff; in this very unusual
meeting, it was decided that Amanda would be transferred. Tr. at
443 - 45. (But this conflicts with Petitioner's testimony that the
decision to transfer was her decision. Tr. at 533.)
Of the helicopter (Life Star) or ground (Jay Stork) neonatal
transportation units available for the transfer, Petitioner chose
the latter, which took one hour and a half to arrive from Kansas
University Medical Center, one or two hours to take custody of
Amanda, and another one and one half hours for the return trip.
Tr. at 532 - 35. The RT had been urging Petitioner to call for the
helicopter transport unit, Life Star, since 10 minutes after
Amanda's birth. Tr. at 517; I.G. Ex. 1 at 3. The helicopter
transport unit would have arrived at Anderson County Hospital in no
more than 30 to 40 minutes, less if the helicopter was already
airborne at the time of the call. Tr. at 441.
Petitioner asked for findings by me that Anderson County Hospital
did not have supplemental fluids required by newborns, and Amanda
needed supplemental fluids when she was transferred to the tertiary
care unit. P. Proposed Findings of Fact at 10 (citing Tr. at 494,
497, 532). These facts may be true, but Petitioner's decision to
order the transfer appear to have been motivated more by the
nonmedical factors already discussed. Moreover, Petitioner's
decision to order ground transportation for the transfer, instead
of the speedier helicopter transport service that was also
available, appears to be further manifestation of Petitioner's
failure or refusal to acknowledge the medical needs of Amanda.
G. Petitioner's inadequate documentation in Amanda's case is
further evidence that she created unnecessary risks for Amanda on
May 20, 1992.
An attending physician, acting in accordance with professionally
recognized standards of health care, needs to provide documentation
of her assessments of the patient, the tests that were ordered, and
sufficient progress notes for other health care providers to
ascertain the patient's condition, history of treatment, and
progress. Louis W. DeInnocentes, Jr., M.D., DAB CR247, at 45 - 46
(1992). Dr. Schwarting explained that complete documentation --
including history and physical examination results, admission
notes, progress notes, and discharge summary -- not only
establishes good communication between health care providers, it
also helps the physician to recall particular information
concerning the patient. Tr. at 204.
Here, the deficiencies in Petitioner's documentation were
significant, in that Amanda was being transferred to another
facility to be treated by doctors and nurses who had not personally
observed details of her poor health at birth and needed a good
understanding of what had been done on Petitioner's orders and why.
Good communication between Petitioner and the health care
professionals at Kansas University Medical Center was important in
this situation. I therefore agree with the I.G. that Petitioner
deviated from professionally recognized standards with her
inadequate documentation.
Petitioner asks that I find "[t]he medical records of Amanda['s]
delivery are not documented correctly and are incomplete." P.
Proposed Findings of Fact at 11. Petitioner contends also that
incomplete records "in and of itself" are not an indication of a
deficiency in standard of care. P. Proposed Findings of Fact at
11. I agree with Petitioner and the I.G. that the records in
Amanda's case are inadequate. However, I find that Petitioner is
responsible for the inadequacy because she failed to gather the
information that would have made the medical records more complete.
Petitioner's inadequate documentation is consistent with and an
accurate reflection of Petitioner's substandard medical knowledge
and the ensuing inferior quality of patient care.
Petitioner has asserted inadequate documentation as a response on
more than one occasion when the PRO has criticized the quality of
her care to patients. The totality of the evidence persuades me
that Petitioner uses inadequate documentation to signify her
disdain for some of the PRO's criticisms. For example, when she
alleged inadequate documentation in the case of a patient named OB,
Petitioner testified repeatedly about having failed to enter
certain information required by the PRO in the charts, and such
testimony implied that she had actually ordered the tests thought
appropriate by the PRO but failed to record them. See, e.g., Tr.
at 561 - 62. Later, when asked directly if she had ordered such
tests, she answered she had not. Tr. at 562 - 63. Similarly,
Petitioner acknowledged that, even if she had ordered blood gas and
blood sugar tests for Amanda, Petitioner "would have basically done
the same thing" for Amanda. I.G. Ex. 14 at 65. I therefore
conclude that, in Petitioner's mind, the tests or procedures found
appropriate by the PRO amounted to nothing more than documentation
requirements, i.e., something that was of no practical use to her,
but which she would need to do pro forma so she could make the
entries on the charts to satisfy the PRO's review of her records.
There is no basis for me to believe that Petitioner provided better
or more appropriate patient care than what she thought to write
down in Amanda's records.
III. Petitioner's definition of "gross and flagrant" violation is
incorrect.
Petitioner denies that she could have "grossly and flagrantly"
violated her professional obligations to Amanda. Tr. at 576. She
contends that the PRO has attributed an incorrect definition to
that term. Tr. at 577. To Petitioner, a "gross and flagrant"
violation means that the physician did not "give a darn." Tr. at
576 - 77. She believes she "gave a darn" and therefore committed
no gross and flagrant violation of her professional obligation to
Amanda under section 1156 of the Act.
I think it sufficient to note that physicians who wish to provide
services to Medicare patients and Medicaid recipients must know
more and do more than "give a darn" about their patients.
IV. The possibility that Amanda may have genetic defects or may
have suffered injuries or brain damage before Petitioner delivered
her does not suffice as an affirmative defense to the I.G.'s basis
for excluding her.
Petitioner placed evidence before me concerning the possibility
that Amanda may have genetic defects or may have suffered prenatal
injuries or brain damage before birth that were not caused by
Petitioner. E.g., P. Exs. 8, 10, 17, 19/ 18, 19; Tr. at 341, 387
- 88. I admitted such documents because Petitioner contended that
Amanda's condition before birth is relevant to her defense. Tr. at
20. At the time of their admission, Petitioner and other witnesses
had not yet testified concerning the standard of care that was
appropriate to Amanda's situation. Before hearing the witnesses'
testimony, I considered it possible that there might exist
standards of care that are uniquely applicable to the delivery and
aftercare of genetically or prenatally impaired newborns.
Therefore, I did not wish to foreclose a possible avenue of defense
for Petitioner.
At hearing, Petitioner did not attempt to prove as an affirmative
defense that her actions and omissions with respect to Amanda had
been influenced in any way by her suspicion or knowledge that
Amanda may have been genetically or prenatally impaired. In fact,
Petitioner repeatedly explained her actions in controversy by
asserting that she believed at the time of Amanda's birth that
Amanda was a healthy and normal baby. Even in her earlier
correspondence with the PRO, she expressed her suspicion that
another baby had been "substituted" for the healthy one she
delivered on May 19, 1991. I.G. Ex. 17 at 2. It was not until a
malpractice lawsuit had been filed against her that she began to
hear reports that Amanda's mother might have been drinking,
smoking, using drugs, staying out late, and eating poorly during
pregnancy. Tr. at 471 - 73. Thereafter, Petitioner formed a
belief that the conduct of Amanda's mother prior to delivery
contributed to Amanda's cerebral palsy (Tr. at 473), and her
malpractice defense attorney has sought expert opinions on the
possibility of prenatal injuries or genetic imperfections (see,
e.g., P. Exs. 8, 10).
Since the conclusion of the evidentiary hearing and the closure of
the evidentiary record, Petitioner has made repeated motions to
supplement the record with an additional report to Petitioner's
malpractice defense attorney concerning the possibility that
Amanda's present health problems may have prenatal origins. I have
denied such requests, for the reasons stated in my ruling dated
December 16, 1993.
While I am aware that there exists a possibility that Amanda
suffers from cerebral palsy and other afflictions due to prenatal
injuries or genetic abnormalities, I do not find that the care
Petitioner delivered to Amanda was consistent with professionally
recognized standards. Petitioner's efforts to exculpate herself by
finding fault in others is relevant to the issues of Petitioner's
trustworthiness and whether the length of exclusion is reasonable.
Amanda's prenatal condition is an inapposite defense to the I.G.'s
authority to direct and impose an exclusion. The I.G. has not
contended that Petitioner caused actual damage to Amanda. A "gross
and flagrant violation" under section 1156(a)(2) of the Act can be
proven by evidence that Petitioner's actions or omissions presented
an imminent danger to the health, safety, or well-being of her
patient, or that Petitioner placed her patient unnecessarily in a
high-risk situation. 42 C.F.R. 1004.1(b).
Comparative fault and contributory negligence are not issues before
me. Petitioner has inappropriately asked me to make formal
findings that Amanda's mother had not followed Petitioner's
prenatal care instructions, and, therefore, the mother's conduct
prior to delivering Amanda contributed to Amanda's having cerebral
palsy. P. Proposed Findings of Fact at 2 - 3. Petitioner asks for
these findings in reliance on information she claims to have
received from Amanda's mother's foster mother. Tr. at 471 - 72.
If such information had been known to Petitioner prior to her
delivery of Amanda, Petitioner should have anticipated
complications and poor health in the baby, and I would find
Petitioner's conduct even more egregious than I have. However,
Petitioner does not claim to have had such information prior to
Amanda's birth (Tr. at 472), and I find this multiple,
uncorroborated hearsay to be inherently unreliable as alleged by
Petitioner in her efforts to shift attention away from the quality
of the treatment she provided to Amanda.
More importantly, it is not possible to reconcile Petitioner's
professional conduct at issue with Amanda's prenatal problems
(assuming Amanda had any problems independent of those that might
have been caused by Petitioner's failure to initiate oxygen therapy
promptly when Petitioner should have equated heavy meconium
staining and severe fetal brachycardia with fetal distress).
Whether or not Amanda had genetic defects or prenatal injuries,
professionally recognized health care standards did not permit
Petitioner to treat Amanda as a normal, healthy newborn who did not
need any of the procedures, interventions, or tests identified by
the I.G.'s expert witnesses. Except for stubbornly maintaining
that she saw all infants as healthy, Petitioner has offered no
contrary medical conclusion. Nor has Petitioner attempted to prove
that genetically defective newborns or newborns who suffer prenatal
injuries would be impervious to the risks created by Petitioner,
such as oxygen deprivation, the possibility of inhaling meconium,
suffering cold-stress and hypoxia, becoming hypoglycemic, becoming
infected, or having their intestines rupture.
I find wholly credible and reasonable Dr. Schwarting's opinion
that, however a baby's cerebral palsy is caused, a physician has a
duty to resuscitate all newborns the same way, to aggressively
intubate those newborns, to get their oxygen level up, and to avoid
their "downhill" slide. Tr. at 199. Dr. Allen gave similar
testimony to the effect that, had appropriate tests been timely
ordered by Petitioner, earlier testing could have revealed problems
that warranted treatment even though the same tests given 24 hours
later yielded negative results. Tr. at 119. In addition, there is
no evidence that Petitioner adjusted the care she gave Amanda due
to the possible existence of prenatal abnormalities. I simply
cannot excuse Petitioner's having created unnecessary health risks
for Amanda because, after Petitioner failed in her professional
obligations to Amanda, Petitioner found reasons to suspect that
Amanda may have genetic or other prenatal problems as well.
Nothing before me remotely suggests that a respiratorily depressed
newborn in Amanda's condition deserved a lesser quality of medical
care and attention than that described by the I.G.'s witnesses.
The dangers created by Petitioner could have caused
life-threatening complications or additional injuries even to a
newborn with possible genetic defects or prenatal injuries. I
sincerely hope that Petitioner is not suggesting with her
affirmative defense that, because Amanda may have been genetically
imperfect or unhealthy in utero, Amanda therefore deserved to be
exposed to the risks of harm created by Petitioner.
V. The I.G. has established by the preponderance of the evidence
that Petitioner is unwilling or unable to meet her obligations
under section 1156(a) of the Act.
Both Petitioner and the I.G. agree that Petitioner's treatment of
Amanda is unique to her obstetrics practice. I.G. Br. at 21; P.
Br. at 21. Before forwarding Amanda's case to the I.G. for review
with a recommendation for a 10-year exclusion, the PRO had assigned
Amanda's case a Level III quality of care problem, meaning that, in
the PRO's opinion, there was a "[c]onfirmed quality problem with
significant adverse effects on the patient." I.G. Ex. 5. 20/ The
PRO had also endeavored to negotiate a CAP with Petitioner to
correct the type of deficiencies found in Amanda's care. I.G. Ex.
8. The I.G. considered Petitioner's failure to enter into a CAP
proposed by the PRO, the facts in Amanda's case and the facts in
the 13 other patient cases also reviewed by the PRO. I.G. Ex. 25
at 3 - 5. The I.G. found Petitioner unable to meet her obligations
under section 1156(a) of the Act due to her "lack of current
medical practices" and the problems identified by the PRO in the 13
other cases. Id. at 3.
At hearing, the I.G. presented testimony from Dr. Schwarting, a
reviewing physician for the PRO in some of the 13 cases, to
summarize and explain the problems the PRO or he had identified in
each of those cases. See, e.g., Tr. at 205, 210, 218; I.G. Ex. 28
to 40. Even though Dr. Schwarting did not evaluate all of the 13
cases for the PRO, his testimony helped summarize and clarify what
was stated by the PRO in its notices to Petitioner. There was no
indication that he had reached any opinion on the basis of
documents not in the PRO's possession. Where he expressed his own
opinions on the cases he had not reviewed for the PRO, his opinions
did not vary significantly from the written conclusions of the PRO.
Petitioner had the opportunity at hearing to dispute the accuracy
of Dr. Schwarting's summaries and opinions on all 13 cases. She
did not dispute the accuracy of his summaries, but she did explain
her present perspectives on the problems identified by the PRO.
I find that the preponderance of the evidence supports the I.G.'s
conclusion that Petitioner is unwilling or unable to comply with
her obligations to conform her practice to professionally
recognized standards of health care. Petitioner's treatment of
Amanda, along with Petitioner's recent justifications for her
actions and omissions, has demonstrated an intransigence on
Petitioner's part that reflects her unwillingness and inability to
substantially modify her health care practices. Moreover,
Petitioner's treatment of Amanda and the 13 other patients
identified by the I.G. demonstrate deficiencies in Petitioner's
medical knowledge that render her unable to meet her obligations
under section 1156(a) of the Act. There is insufficient support
for Petitioner's contention that her practices have changed
dramatically over the past six years. Tr. at 558.
In my earlier ruling on the serious risk issue, I have detailed the
treatment problems in the cases of the 13 patients identified by
the I.G., together with Petitioner's defenses. 21/ However, I will
summarize the history of Petitioner's dealings with the PRO and her
explanations of the 13 cases because such evidence persuaded me
that Amanda's was not an isolated case, that Petitioner has
maintained her unique standards of care despite the PRO's efforts
to remedy them, and that Petitioner's base of medical knowledge
remains significantly below current professional standards. Having
examined the 13 cases together with what occurred in Amanda's case,
I find fully credible the opinions of Dr. Allen that Petitioner has
given "multiple demonstrations in the past of [her] lack of current
common knowledge regarding [in]numerable medical facts that would
make the treatment of those patients . . . dangerous" and her
"medical knowledge is not of sufficiently current character that
she can provide reasonably up-to-date care that meets currently
recognized standards." Tr. at 39, 42.
A. The Quality of Care Problems Identified by the PRO in 1987
On March 17, 1987, the PRO initiated an intensified review 22/ of
the care rendered by Petitioner because it noted a pattern of
quality of care problems. I.G. Ex. 16 at 3. The PRO continued its
intensified review of Petitioner's Medicare admissions to hospitals
after October 1987, when the PRO ended some aspects of its
intervention. Id.
In May 1987, the PRO notified Petitioner that it had assigned to
her treatment of HH a "Class II" designation, which meant
"nonstandard or unusual treatment/practice that clearly endangers
the patient, resulting in short-term detrimental effect." I.G. Ex.
28 at 2, 11. 23/ This patient, then 67, had been admitted to
Anderson County Hospital with ashen coloring, difficulties in
breathing, clammy skin, increased perspiration, and wet riles in
both lungs. I.G. Ex. 28; Tr. at 205, 559. Among the problems
noted by the PRO was Petitioner's failure to order an EKG
(electrocardiogram) when the patient was admitted. Id.; I.G. Ex.
16 at 4.
Even though the medical records show that HH was alive for more
than one hour after his admission (see Tr. at 208), Petitioner
contended to the PRO that she had no time to order an EKG because
HH died 20 minutes after admission. I.G. Ex. 28 at 9. At hearing,
Petitioner indicated that an EKG was unnecessary because she knew
HH was about to die, and did die, in any event. Tr. at 559.
I find Petitioner's reasoning in HH's case to be representative of
the excuses she had offered in the other patients' cases as well as
in Amanda's case. Petitioner usually blames her patients' poor
health (e.g., HH's having been on the threshold of death and
Amanda's possible genetic defects) when the adequacy or
appropriateness of her treatment efforts is questioned. I find
Petitioner's approach to be inappropriate to the patient care
issues under consideration. Under professionally recognized
standards of care, a doctor has a duty to do what is appropriate
for the patient's condition. After the doctor has failed in such
a duty to the patient, it does not follow that the doctor should
then conjecture about the inevitability of death or poor health
problems to excuse the failure.
On May 7, 1987, the PRO notified Petitioner that it had assigned to
her treatment of RL a "Class II" quality problem designation, the
same as in HH's case. I.G. Ex. 29 at 39. This 93-year-old female
patient had been found by her neighbors and was admitted to the
hospital due to exposure. I.G. Ex. 16 at 5. She was cold, blue,
and had been neglecting herself for days. Id. The PRO criticized
Petitioner's failure to order the continuation of the patient's
antibiotics on her discharge, failure to order a diabetic diet for
the patient who was hyperglycemic, and failure to investigate the
cause of the patient's elevated enzymes. Tr. at 210 - 12; see also
I.G. Exs. 29; 16 at 5.
At hearing, Petitioner refuted these criticisms by claiming that
the result she achieved for RL without the tests was good because
RL survived. Tr. at 560. As in Amanda's case, Petitioner
attempted also to refute or minimize the merits of the PRO's
criticism by asserting that "the chart is terrible." Id.
On October 12, 1987, the PRO notified Petitioner that it was
continuing to identify patterns of care that required her
attention, such as lack of generally accepted followup to clinical
findings and appropriate testing and monitoring of cardiac and
respiratory functions for those patients in her care. I.G. Ex. 41
at 10.
In December 1987, the PRO notified Petitioner that it had assigned
to her treatment of OB a "Level I" designation, which means
"nonstandard or unusual treatment/practice that potentially
endangers the patient, but no detrimental effect is realized."
I.G. Ex. 30 at 4, 6. OB was diagnosed to have various respiratory
problems. Tr. at 212. The PRO criticized Petitioner for her
failure to order ABGs (arterial blood gas tests) for this patient,
even though he was found to have oxygen saturation of 79 percent on
room air. Tr. at 212 - 13; I.G. Exs. 30; 16 at 4.
Petitioner told the PRO that ABGs could do nothing except make the
patient more anemic. Tr. at 213; I.G. Ex. 30 at 2. 24/ At
hearing, Petitioner testified that OB's case involved only
inadequate documentation that occurred many years ago. Tr. at 561.
However, her testimony with respect to Amanda's care made clear
also that she still sought to rely on inadequate documentation as
an excuse for substandard care. Moreover, Petitioner failed to
obtain ABG tests for Amanda, whom she treated several years after
the PRO criticized her for failing to obtain ABG tests for OB, also
a patient with respiratory problems and low oxygen saturation in
the blood on room air.
Petitioner's testimony concerning OB's case and other cases
persuades me that she does not understand the usefulness of
diagnostic tests. To Petitioner, the tests thought appropriate by
the PRO amount to nothing more than documentation requirements,
i.e., something that is of no practical use to her, but which she
would need to order so she could make the entries on the charts to
satisfy the PRO's review of her records. See discussion supra.
In June 1987, the PRO notified Petitioner that it had assigned to
her treatment of BH a "Level I" quality problem designation, the
same as for OB's case. I.G. Ex. 31 at 46. On admission to the
hospital, this 86-year-old patient had shortness of breath,
congestive heart failure, and possibly pneumonia. Tr. at 215; see
also I.G. Ex. 31. However, Petitioner did not order ABGs or
respiratory therapy for assessments, and, according to the records
provided to the PRO, the patient appeared very ill with an
increased respiratory rate even at the time of her discharge. I.G.
Exs. 31 at 46; 16 at 5.
Petitioner explained to the PRO that she did not order ABG tests
because BH was cyanotic, and ABG tests would have accomplished
nothing except to deprive the patient of needed blood. I.G. Ex. 31
at 44; see also Tr. at 217. She also cited nonmedical reasons,
such as the patient's limited budget, to explain her other
omissions in treatment and for having ordered discharge when the
patient was still not well. Id. 25/ She further told the PRO to
"get off my case" as she had a good success rate and:
[f]urther be it known that I went to school when you did have
to know a little something and you did not have to do a lot of
unnecessary tests. I have not become extravagant in ordering
tests. I will try to do better in the future.
I.G. Ex. 31 at 44.
In testimony before me, Petitioner alleged only that her management
of patients has changed considerably during the six years since she
treated BH. Tr. at 564. However, Petitioner repeated her
sentiments concerning the uselessness of diagnostic tests when she
answered my question on what, if any, benefit she had derived from
one of her CAPs:
Well, companionship and learning more the modern ways of doing
things. See, I came from when you had to know something. I mean,
it is the art of medicine.
Nowadays, it is science. I mean, if you have an MI, you have
got it -- you don't just know it. You have got to prove it with a
bunch of tests and your enzyme tests and your EKG's and your
Doppler studies and all that type of thing.
Tr. at 582. I infer from this answer and other relevant evidence
that Petitioner continues to believe that tests are superfluous for
doctors of her training and skill who can make diagnoses and decide
treatment courses without them.
Dr. Henderson testified that Petitioner had started practice in the
days when "medicine was maybe 20 percent science and 80 percent
where she learned how to put a stethoscope on a human and check
them." Tr. at 447. He pointed out also:
Much that she does for the patient doesn't come out of a
bottle or the series of tests that she does for the patients
because she takes care of a group of patients that need, probably,
as much as anything, kind, compassionate understanding care.
Tr. at 448.
Nevertheless, as the cases discussed herein demonstrate, there may
be significant underlying problems that cannot be discerned on
examination alone. Not all patients need only Petitioner's
kindness, compassion, and understanding. There have been many
advances in medical technology and treatment techniques since the
days when 80 percent of what a physician did was with a
stethoscope. Today, a physician needs to have the knowledge and
willingness to make use of the commonly known medical advances in
order to treat patients in a manner commensurate with currently
recognized standards of professional care. Professionally
recognized standards of care for the present day and age no longer
permit a physician to practice in the same manner as Petitioner did
more than four decades ago. I agree with Dr. Allen that Petitioner
has given multiple demonstrations of her lack of current common
medical knowledge regarding many medical facts that have rendered
her treatment of patients dangerous by today's standards. Tr. at
42. The I.G. correctly concluded that Petitioner's inability to
substantially comply with her obligations under section 1156(a)(2)
of the Act is demonstrated by her "lack of current medical
practices." I.G. Ex. 25 at 3.
B. Evidence on the Quality of Care Problems Identified by the PRO
in 1988
On March 21, 1988, the PRO notified Petitioner that it had assigned
to her treatment of LT a "Level I" quality problem. I.G. Ex. 32 at
35. Petitioner had ordered the admission of this 84-year-old
patient for a severe cough, for a cut elbow that had required
suturing, and for having hit her head while falling down. Tr. at
218; I.G. Exs. 32; 16 at 5. A treatment problem in this case was
that Petitioner did not order monitoring of the patient's possible
head injury. Tr. at 218; I.G. Exs. 16 at 5; 32 at 33; 34.
Petitioner did not explain her care to the PRO.
Petitioner testified that LT had fallen and gotten a small cut on
her arm, but Petitioner did not believe the patient had anything
more serious than "minimal concussion." Tr. at 565. Petitioner
alleged that she ordered a hospital admission that was not
medically necessary because LT "was elderly and didn't have anybody
to look after her at her home." Id. Petitioner therefore reasoned
that the care she rendered was adequate and appropriate. Id.
Petitioner's excuse begs the question of whether she violated
another subsection of the Act, which places an obligation on all
Medicare and Medicaid providers to assure, to the extent of their
authority, that the services they render under the programs will be
"only when, and to the extent, medically necessary." Section
1156(a)(1) of the Act. Petitioner's unnecessary admission of a
Medicare beneficiary to a hospital, if true as alleged, wasted
program funds on unnecessary hospital stays and possibly diverted
available hospital resources from those patients who were truly in
need of the acute level services available only at hospitals.
C. Evidence on the Quality of Care Problems Identified by the PRO
in 1989
On September 25, 1989, the PRO notified Petitioner that it had
assigned to her treatment of HA during one hospitalization a "Level
III" designation (i.e., "Medical mismanagement with significant
adverse effects on the patient"). I.G. Ex. 41 at 11. The PRO
identified concerns with inadequate preoperative cardiorespiratory
evaluation, inadequate preoperative blood workup, inadequate
assessment of operative risk, and inappropriate treatment of
congestive heart failure. Id.; I.G. Ex. 16 at 5. The intervention
the PRO chose to do as a consequence included a focused review of
Petitioner's cardiorespiratory Medicare discharges for 15 cases, or
for the period of 90 days starting from April 1, 1989. I.G. Ex. 41
at 12.
On October 19, 1989, Petitioner entered into a CAP. I.G. Ex. 16
at 3. Under this plan, the PRO conducted a focused review of all
the Medicare patients with cardiopulmonary problems that Petitioner
had discharged from hospitals, as well as a 100 percent prospective
review of all of Petitioner's Medicare discharges; the CAP required
her also to obtain continuing medical education (CME) directed at
the diagnosing and treating of myocardial infarctions, congestive
heart failure, and pre- and post- operative care. Id. Petitioner
met the CME requirements of the CAP. Id.
On October 25, 1989, the PRO notified Petitioner that it had
assigned to her treatment of HA during two earlier hospitalizations
a "Level II" designation (i.e., "Medical mismanagement with the
potential for significant adverse effects on the patient"). I.G.
Ex. 33 at 2, 5 - 7.
According to the PRO, during HA's first admission to the hospital
by Petitioner (assigned a Level II designation), the quality of
care problems included inadequate laboratory evaluations of a
possible acute myocardial infarction, no serum potassium evaluation
despite intravenous Lasix being given, failure to repeat liver
enzyme studies despite the patient's anorexia and vomiting, and no
ABG tests, despite dyspnea. I.G. Ex. 16 at 6. The second Level II
designation applies to HA's admission to the hospital's skilled
nursing facility on Petitioner's orders. Id. The treatment
provided by Petitioner for the second admission included an
inappropriate selection of antibiotics for his urinary tract
infection, the use of Quinidine on a PRN (as needed) basis for his
cardiac arrhythmias, and the absence of followup on liver-function
tests. Id. So that surgery could be performed, HA was
subsequently readmitted to the acute care unit of the hospital from
the skilled nursing facility. Id. This third admission by
Petitioner (assigned a Level III designation) was problematic
because the PRO questioned the stability of the patient for surgery
at the time of transfer. Id. The PRO's other concerns for HA's
final hospital admission (HA died in the hospital) included
inadequate preoperative cardiorespiratory evaluation, inadequate
preoperative blood work-up, inadequate assessment of operative
risk, and inappropriate treatment of congestive heart failure. Id.
Petitioner had admitted HA to the hospital on more than one
occasion for chest pain, poor color, and a possible myocardial
infarction. I.G. Ex. 33; Tr. at 220. At hearing, Dr. Schwarting
explained the several different types of problems noted by the PRO
in Petitioner's treatment of the patient, such as Petitioner's not
having ordered laboratory tests that were sufficient for
determining whether a heart attack had occurred, not having
documented a "do not resuscitate" request alleged by Petitioner,
not having taken actions that conformed to this alleged "do not
resuscitate" request from the patient, and not having been in good
control of the treatment as the patient's attending physician. Tr.
220 - 25; see also I.G. Ex. 33 at 8.
Petitioner explained at hearing that HA was a 93-year-old gentleman
and had been her patient for more than 40 years when he passed
away. Tr. at 566. Petitioner reiterated that there was a "do not
resuscitate" request by the patient. Tr. at 566. She then alluded
to an "untimely and ill advised" surgery that she did not attempt
and from which the patient died. Tr. at 567. I infer that
Petitioner was addressing the Level III designation the PRO had
assigned to the care she provided HA during his final hospital
stay.
Petitioner testified that she realized that HA needed an evaluation
by a cardiologist, and she did not attempt to do the evaluation.
Tr. at 566. However, she could have transferred the patient but
did not. Tr. at 566 -67. She said she advised another doctor of
the poor risk factors for surgery, but the other doctor proceeded
with surgery. Tr. at 567. She stated then that the patient's
death was not the other doctor's fault ("[i]t was just galloping
old age"), and she claimed also that she did not harm the patient
or place him at risk. Id. I was not able to discern from her
explanations the extent of responsibility, if she felt she had any,
for preventing HA's death. Instead, her opinion about the doctors'
not being at fault is consistent with her tendency to blame the
patient's condition when a patient failed to improve under her
care.
On October 10, 1989, the PRO notified Petitioner that it had
assigned a "Level II" quality problem designation to her treatment
of GH. I.G. Ex. 34 at 5. GH had a history of recently diagnosed
cancer of the prostate; he asked Petitioner to perform an
orchiectomy (excision of one or both testes) as treatment for that
disease. I.G. Ex. 34; Tr. at 226. The PRO accepted Petitioner's
explanation that the patient had been instructed on
self-catheterization after surgery, even though there was no
documentation of that fact. I.G. Ex. 34 at 2 - 4. However, the
PRO found other aspects of Petitioner's treatment problematic.
First, the treatment was problematic in that Petitioner provided no
written explanation for the drainage on the dressing from the
surgery site on the morning that the patient was discharged, and
Petitioner claimed to have been surprised and chagrined by the
PRO's finding of a drainage problem. I.G. Ex. 34 at 3, 4; Tr. at
226 - 28. Petitioner explained at the hearing that GH was a
70-year-old patient. Tr. at 567 - 68. She described the surgery
she performed as "a beautiful job," and she said she had sent him
home the following day. Tr. at 568.
Dr. Schwarting testified that Petitioner's alleged unawareness of
the drainage problem did not make sense to him since the drainage
was documented in the nurses' notes. Tr. at 226 - 28. In Dr.
Schwarting's opinion, Petitioner should not have been surprised
that the PRO would discern the drainage problem that was apparent
from the nurses' notes. Tr. at 227.
The records concerning GH also lacked any patient history and
progress notes, and contained only a bit of information concerning
the patient's "physical." Tr. at 226. 26/ I find the
documentation problems to be related to Petitioner's having excised
GH's body parts based on the patient's own verbal report of his
pathology. I.G. Ex. 16 at 6. Petitioner did not await any
official notification of carcinoma of the prostate from the
University of Kansas Medical Center, where GH had been referred;
nor had she received any official written recommendation from that
institute concerning an orchiectomy when she performed the
procedure. Id. The PRO believed that Petitioner proceeded
prematurely before receiving such information. Id.
These findings by the PRO are consistent with Petitioner's
testimony at hearing that the patient told her of a recommendation
to have an orchiectomy and that she performed the bilateral
procedure at the patient's request. Tr. at 567 - 68. Petitioner
did not indicate that she saw anything wrong with relying on a
patient's information in this manner. Her testimony did not
intimate that there might have been a need to secure confirmation
of the patient's pathology or the patient's belief that orchiectomy
had been recommended as appropriate treatment. I find Petitioner's
actions in the GH's case to have been premature, unsafe for GH, and
lacking in sound professional judgment.
D. Evidence on the Quality of Care Problems Identified by the PRO
in 1990
On March 2, 1990, the PRO notified Petitioner that it had assigned
to the treatment of FP a "Level II" designation (i.e., "Medical
mismanagement with the potential for significant adverse effects on
the patient"). I.G. Ex. 35 at 10. The PRO's concerns included
Petitioner's failure to identify the etiology of FP's melena (the
passage of dark stools stained with altered blood) as recommended
by a gastroenterology consultant, Petitioner's failure to consider
the possibility of obstructive uropathy as a cause for FP's renal
failure, Petitioner's failure to address the etiology of FP's
severe hyponatremia (salt depletion), and the administration of
excessive doses of IV Digoxin (medication used in the treatment of
heart failure) without adequate documentation in the chart to
warrant its use in the first place. I.G. Ex. 16 at 7. According
to the PRO, Petitioner should have treated this 86-year- old
patient more aggressively after having admitted her to the hospital
for 12 days. I.G. Ex. 35 at 10; Tr. at 229 - 30.
At hearing, Petitioner said of this patient, "[t]his was an
elderly, nursing home patient with renal failure, and she should
never have even been admitted to the hospital because her body was
too diseased to try to bring back anything." Tr. at 569. Such
testimony implied that someone other than Petitioner had admitted
this patient. However, upon being asked who had admitted this
patient, Petitioner acknowledged that she ordered the admission but
explained that the patient's son insisted on the hospitalization
and "I should have been more persuasive and said, it isn't
appropriate to put her in the hospital." Id. I find these excuses
as problematic as in the 1988 case involving LT. Moreover,
Petitioner's opinion concerning FP's inevitable death is inherently
suspect since Petitioner failed to adequately assess the sources of
FP's various problems.
On March 26, 1990, the PRO notified Petitioner that it had assigned
to her treatment of EN a "Level II" quality problem designation as
well. I.G. Ex. 36 at 4 - 6. This 78-year-old nursing home patient
was admitted to the hospital with symptoms that included congestive
heart failure and bronchial pneumonia. E.g., I.G. Exs. 36 at 9; 16
at 7. According to the nurse's notes, the patient had swelling in
her ankles, was diaphoretic (perspiring profusely), and had labored
respirations of 36 times per minute because she was in respiratory
distress. Tr. at 231.
The PRO found Petitioner's treatment of EN problematic due to a
significant lack of documentation; that is, no admission notes, no
"history & physical, etc." were put on the patient's chart at
the
time of admission or after she passed away. I.G. Ex. 36 at 5.
Moreover, Petitioner first saw this patient two and one-half hours
after she was admitted in an obviously critical condition. Id.;
Tr. at 231. The PRO noted the discrepancy between Petitioner's
treatment orders and her assertion to the PRO that, at admission,
EN's "end was inevitable" even though EN continued to survive.
I.G. Exs. 36 at 3; 5. The PRO did not accept Petitioner's
contention that EN had been "dying in the nursing home for several
days and was admitted to die [in the hospital]." I.G. Ex. 16 at 7
- 8. The chest x-rays, an EKG, a liquid diet, and other treatment
Petitioner ordered for this patient were all contrary to
Petitioner's later declarations that the patient was dying and
needed only to be made comfortable in the hospital. Tr. at 233 -
34; I.G. Ex. 36 at 5. The PRO assigned the Level II designation
also because Petitioner never explained in the charts or after the
fact why more therapeutic measures were not undertaken, and there
was no documentation in the patient's records of a "do not
resuscitate" order. Tr. at 232 - 34.
In response to criticisms of the care she rendered to EN,
Petitioner testified at hearing that her decision to admit this
dying patient to the hospital was ill advised. Tr. at 570.
Petitioner claims to have "made some effort to try to reverse the
dying findings." Id. I find her testimony concerning EN very
similar to the excuses she offered for having failed to order
appropriate treatment for LT and FP, the other two patients she
said she admitted to the hospital without medical necessity. For
reasons already stated, I do not find this excuse credible.
On March 2, 1990, the PRO notified Petitioner that it had assigned
to her treatment of GP a "Level I" designation (i.e., "Medical
mismanagement without the potential for significant adverse effects
on the patient"). I.G. Ex. 35 at 5. This 91 year old patient was
admitted to the hospital with an acute abdominal obstruction. I.G.
Exs. 16, 35, 37. The problem the PRO initially found in this case
was Petitioner's failure to adequately address GP's elevated liver
enzymes that were revealed by the routine admitting laboratory
tests. I.G. Ex. 16 at 7; Tr. at 236 - 37; I.G. Ex. 35 at 4.
Later, the PRO accepted Petitioner's proof that follow-up tests
were done on an out-patient basis. I.G. Ex. 16 at 7. The PRO
remained concerned that the foregoing information was not
documented in the charts. Id.
During April 1990, the PRO notified Petitioner that it had assigned
to her treatment of IM a "Level II" quality problem designation as
well. I.G. Ex. 38 at 4 - 6. IM, a 73-year-old patient, was
hospitalized on complaints of chest pain underneath the left
clavicle and epigastric distress. I.G. Ex. 38 at 8. Petitioner's
final diagnosis included acute cholecystitis (inflammation of the
gallbladder). Id.; I.G. Ex. 16 at 8. The PRO found that
Petitioner had diagnosed chronic hepatitis without any evidence in
the chart to support such a diagnosis. I.G. Ex. 16 at 8. The PRO
found also that Petitioner's choice of antibiotic, penicillin, was
inappropriate for treating the patient's acute cholecystitis. I.G.
Ex. 38 at 4, 5; Tr. at 238. At hearing, Dr. Schwarting explained
that penicillin does not cover the multitude of bacteria associated
with acute cholecystis, and Petitioner put the patient at risk for
progressive infection, abscess, or other complications with her
choice of antibiotics. Tr. at 238 - 39.
Petitioner acknowledged at hearing that the PRO had found
penicillin inappropriate, but she argued --
I gave her penicillin, and she got well. So I mean, who can
argue with success?
Tr. at 571. I inferred from this testimony that Petitioner still
does not understand the risks identified by the PRO and does not
acknowledge the availability of safer antibiotics. I find that
patients should not be exposed to unnecessary risks of
complications when there exists safer antibiotics. The rationale
adopted by Petitioner to explain her use of penicillin for IM
reflects her continued disregard for current professional standards
of care. Moreover, as discussed below in the case of another
patient (RE), Petitioner prescribed other inappropriate antibiotics
in December 1990 after having been alerted to the problem by the
PRO in April.
On April 20, 1990, the PRO notified Petitioner that, of the total
of 19 cases of hers it reviewed, there were four additional Level
II quality problems and an additional Level I problem. I.G. Ex. 41
at 15. The PRO notified Petitioner also that she was to remain on
100 percent retrospective intensified review of all her Medicare
discharges for 90 days beginning on April 1, 1990. Tr. at 76; I.G.
Ex. 38 at 6. The PRO invited Petitioner to help formulate an
additional Corrective Action Plan. Id. Petitioner proposed
various terms, such as having Petitioner's husband proctor her
work. E.g., I.G. Ex. 41 at 21, 23.
On August 13, 1990, in rejecting one of Petitioner's proposals for
a CAP, the PRO notified Petitioner that it was initiating sanctions
against her under section 1156 of the Act because she had
substantially violated her obligations in a substantial number of
cases. I.G. Ex. 41 at 18 - 22. The PRO identified 14 cases and
summarized the problems in each case. Id.
On December 18, 1990, the PRO confirmed the formulation of a CAP
that required Dr. David Henderson to proctor Petitioner on an
ongoing and concurrent basis to confirm her diagnosis and approve
her treatment plan for Medicare patients within 24 hours of their
admission, to review prospectively major therapeutic intervention
(e.g., surgery, transfer in and out of acute care units and
discharges), to review progress on an average of every 48 hours to
determine whether her patient's condition has changed or was
failing to respond to therapy. I.G. Ex. 41 at 25 - 26. The
proctoring was to last up to one year, beginning on January 1,
1991, with the option for the PRO to discontinue or modify it after
six months. Id.
E. Evidence on the Quality of Care Problems Identified by the PRO
in 1991
On January 7, 1991, the PRO notified Petitioner that it had
assigned to her treatment of ND a "Level III" designation (i.e.,
"Confirmed quality problem with significant adverse effects on the
patient"). 27/ This 90-year-old patient was admitted to the
hospital with symptoms of acute abdominal pain and a diagnosis of
perforated ulcer. I.G. Ex. 39. 28/ The PRO was concerned by
Petitioner's failure to recognize the perforation and to obtain
timely consultation. I.G. Ex. 16 at 8. Dr. Schwarting described
ND's perforated ulcer as "a very risky, life-threatening
situation," which is in accord with the PRO's assessment. Tr. at
239; I.G. Ex. 39 at 8. The patient arrived at the emergency room
at 10:00 p.m., but she was not operated on until the afternoon of
the following day, which was an unnecessary delay in surgical care.
Tr. at 240; I.G. Ex. 39 at 8.
In her response to the PRO, Petitioner explained that the delay in
surgery was not unreasonable given the distance which the surgeon
was travelling. I.G. Ex. 39 at 6; Tr. at 240. Dr. Schwarting
explained, however, that when there is an acutely ill patient, the
patient must be treated timely. Id. Thus, according to Dr.
Schwarting, Petitioner should have called another surgeon, or
transferred the patient to Kansas University Medical Center, which
was about an hour away. Id. Dr. Schwarting explained also that
the PRO's finding that Petitioner's use of Lithium for this patient
was inconsistent with professionally recognized standards of health
care was due to the drug's potential for causing life-threatening
complications. Tr. at 243; I.G. Ex. 39 at 8.
At hearing, Petitioner alleged that she had endeavored to do
everything timely for ND. Tr. at 572 - 74. She said she told ND
to go to the hospital immediately, but ND did not go there for six
hours; she called a board certified surgeon living in another town
at about 1:00 a.m. (three hours after the patient's arrival) to
come and operate on the perforated ulcer, but the surgeon said he
would be there later that morning. Tr. at 571 - 72. Petitioner
did not specify whether the surgeon had committed to an arrival
time to do the operation or whether Petitioner had asked him for
his arrival time. The surgeon did not arrive until 8:00 a.m. and
then wanted another chest x-ray to confirm the diagnosis. Tr. at
572. Petitioner testified that, even today, she would make the
same decision to keep the patient instead of transferring her
because a board certified surgeon was coming to do the surgery.
Tr. at 573.
I find that Petitioner contributed significantly to the
unreasonable delay of more than 12 hours by not immediately
recognizing ND's life-threatening condition, by not seeking a
surgical consultation for three hours, by not ordering ND
transferred to another hospital forthwith, and by acquiescing to
the surgeon's delayed arrival. The manner in which Petitioner
distanced herself from the surgeon's actions in ND's case is akin
to her explanations of HA's death from the surgery performed on
Petitioner's referral. The impression she conveyed is that she had
no responsibility to either patient, even though she had been the
attending physician to both and had referred both of them for
surgery.
There is no support for Petitioner's allegation that surgery could
not have been done on ND without a delay of at least 10 hours.
There is also no support for Petitioner's proposition that more
than 12 hours of delay did not significantly increase the risk of
death for ND. While Petitioner's preference for a board certified
surgeon was laudable, it is not credible that only by keeping ND at
Anderson County Hospital could ND have had access to a board
certified surgeon. There is also no evidence to support
Petitioner's contention that transferring the patient to another
hospital, such as the Kansas University Medical Center suggested by
Dr. Schwarting, would have resulted in the same delay of more than
12 hours. Therefore, Petitioner's testimony that she would make
the same decisions again for this patient evidences her continuing
unwillingness and inability to conform her practices to
professionally recognized standards of health care.
The PRO's notice to Petitioner concerning the unreasonable delay in
ND's treatment predated Amanda's birth by several months. The
PRO's notice concerning ND's case should have alerted Petitioner to
evaluate the wisdom of transferring a patient when specialists are
not readily available at Anderson County Hospital and the patient
is critically ill. Yet, several months later, Petitioner again
incurred many, many hours of unreasonable delays before she signed
the order to transfer Amanda to another hospital.
On June 11, 1991, the PRO notified Petitioner that it had assigned
to her treatment of RE a "Level II" designation (i.e., "Confirmed
quality problem with the potential for significant adverse effects
on the patient"). I.G. Ex. 40 at 4. This 68-year-old patient had
a history of diabetes and came to the hospital with a high fever.
I.G. Ex. 40 at 8. After x-rays showed pneumonia, he was admitted
for IV antibiotics. Id. The PRO was concerned with Petitioner's
failure to monitor RE's renal function studies or to obtain blood
level readings of the antibiotics used. I.G. Ex. 16 at 8. The PRO
noted as an additional problem the antibiotic Petitioner used for
this patient with diabetes and pneumonia. I.G. Ex. 40 at 1. Dr.
Schwarting explained that Petitioner's choice of antibiotic,
Garamycin, had placed RE at risk during the 12-day hospital course
because Garamycin has a very high potential for causing
nephrotoxicity or problems with the kidneys. Tr. at 245.
Petitioner asserted, that seven years ago, the hospital lacked the
capacity to provide prompt test results that would have assisted
her in selecting the correct antibiotics for this patient. Tr. at
575. In her view, by the time any test results could have arrived,
the patient would have been well or nearly so. Id.
I reject Petitioner's suggestion that she could not have known the
potential dangers of Garamycin without receiving test results. I
note, too, that the care in question took place in December 1990,
not seven years ago when the conditions may have been as Petitioner
described. Moreover, regardless of when the results could have
arrived, as in her treatment of HH and other patients, it does not
appear that Petitioner ever ordered the tests. In April 1990,
eight months before she treated RE, Petitioner had been alerted to
her improper use of antibiotics in her treatment of IM. Even if I
accepted Petitioner's contentions, the risks created by
Petitioner's selection of a potentially dangerous antibiotic in the
first instance cannot be mitigated by the unavailability of test
results to monitor their actual effects on RE.
VI. Petitioner has not proven that she is willing or able to meet
her obligations under section 1156(a)(2) of the Act.
Petitioner contends that every previous CAP she entered into was
voluntarily ended by the PRO without any problems. P. Proposed
Findings of Fact at 15 (citing Tr. at 76 - 82, 97). She claims
that her practices have changed significantly in the past six
years. Tr. at 558. Petitioner opposes the exclusion at issue on
the belief that her medical practice would be ruined if she agreed
to either one of the two CAPs that have been proposed by the PRO
pursuant to its review of Amanda's case. P. Proposed Findings of
Fact at 16; Tr. at 547 - 52. Petitioner contends that the PRO
unjustifiably refused to allow the formulation of a new CAP, which
would once again allow Dr. Henderson to proctor Petitioner's care
of patients. See Tr. at 40. She expressed a willingness to take
more continuing medical education classes. Tr. at 581. She
believes that the PRO is seeking to punish her with the alternative
CAPs it proposes. Tr. at 547.
I do not find Petitioner's contentions meritorious. For example,
the CAP Petitioner entered into on January 1, 1991 ended in July
1991 only because the plan was limited to Medicare patients. Dr.
Henderson proctored her treatment of Medicare patients, and no
quality of care problems were identified by the PRO for the
Medicare patients she admitted during the period with Dr.
Henderson's oversight. I.G. Ex. 41 at 27. However, the PRO
continued its intensified review of those Medicaid patients
Petitioner discharged after July 1991, that is, after the CAP
ended. Id. Petitioner has been under 100 percent intensified
review by the PRO since at least 1989, and under some type of
review since at least 1987. Tr. at 29 - 30; I.G. Ex. 16 at 3.
Petitioner continues to have 100 percent of her Medicare and
Medicaid cases reviewed retrospectively by the PRO. Tr. at 31. To
date, she has taken part in at least two CAPs. Tr. at 34 - 36, 93
- 94, 96; I.G. Ex. 16 at 3. The reviews, interventions, and CAPs
have not remedied the underlying problems.
Very significantly, the quality problems in Amanda's case arose on
May 19 and 20, 1991, while Petitioner was under the CAP for
Medicare patients. The proctoring by Dr. Henderson did not occur
for Amanda because Amanda was a Medicaid recipient. Given the
resurgence of similar quality problems over the years despite
Petitioner's technical compliance with previously negotiated CAPs
of limited scope, there is no valid basis for concluding that
Petitioner is willing and able to comply substantially with her
obligations under the Act.
The CAPs are proposed by the PRO for the benefit of Medicare
beneficiaries and Medicaid recipients when the PRO discerns a
pattern of substandard care. Tr. at 32. CAPs are not intended to
safeguard the fiscal viability of any physician's medical practice.
Nor are CAPs intended to remedy a physician's knowledge base only
to the extent convenient to that physician. After noting the
problems in Amanda's case, the PRO proposed that Petitioner enter
a mini-residency program of six months, or that she enter a program
in Colorado for the duration necessary to evaluate and remedy her
educational needs. Tr. at 40; I.G. Ex. 16. In rejecting these
proposed CAPs, Petitioner was motivated by her desire to maintain
her current medical practice. Tr. at 546 - 52. She offered to
take continuing medical education (CME) classes because she can do
so without disrupting her existing practice, even though she had
been taking CME classes during the years that she treated Amanda
and the other 13 patients. See Tr. at 469 - 70, 581.
The CAP initiated in October 1989 required her to complete CME in
designated areas. I.G. Ex. 16 at 3. Yet, quality of care problems
continued to arise. In addition, Petitioner claimed that she had
completed more than twice the courses required for maintaining
licensure by the State of Kansas and that she had completed the
required 50 hours for 1993. Tr. at 469, 582 - 84. However,
Petitioner was not able to describe cogently even one continuing
medical education course she had attended or what such education
entailed for her. Tr. at 469 - 70, 583 - 84.
Even at hearing, Petitioner persisted in describing the care she
gave to Amanda and the other 13 patients as "good care" with
"wonderful results." Tr. at 562. Earlier, she alleged to the PRO
that the healthy, normal baby she delivered on May 19, 1991 had
been substituted with another baby in order to maintain a
malpractice suit against her. I.G. Ex. 7 at 2. She contended that
she had fallen victim to a conspiracy to "character assassinate"
her and to "discredit" her care by making it appear inadequate or
casual. I.G. Ex. 4. She believed the hospital staff had been
lying in wait for her to make a "tragic mistake" in order to
thereby prove her incompetency. I.G. Ex. 4 at 1. At hearing, she
denied specifically that she needs training in any aspect of her
current practice. Tr. at 585.
Having acknowledged no deficiency and no problem, Petitioner has
indicated also no commitment to making changes of any specific
nature or to achieving any specific goals. She has therefore given
no evidence of her trustworthiness for being willing or able to
remedy her deficiencies under section 1156(a) of the Act. All
evidence points to the futility of allowing her to choose the
additional classes she wishes to attend as a remedy.
I agree with the I.G. that having another physician proctor
Petitioner again is not an appropriate solution. See Tr. at 41.
First, no doctor has come forth to volunteer as Petitioner's
proctor. I.G. Ex. 16 at 2. Proctoring is cumbersome and not
likely to correct the educational deficiencies in Petitioner's
medical knowledge base. Tr. at 41. There is also no guarantee
that, if Dr. Henderson (Petitioner's nominee for her proctor) were
out of town, there would be another physician to proctor
Petitioner. Tr. at 40 - 41. Proctoring might have to be continued
indefinitely, given the deficiencies in Petitioner's knowledge
base, and having two doctors examining all Medicare and Medicaid
patients is an expensive and inefficient process to have in place
indefinitely. Id.; I.G. Ex. 16 at 2. Moreover, contemporaneous
proctoring by Dr. Henderson for all of Petitioner's Medicare
patients in May 1991 did not eliminate the quality of care problems
for Amanda, a Medicaid recipient. There is no persuasive proof
that another period of proctoring will have lasting benefits for
anyone.
VII. The I.G. has proven by a preponderance of the evidence that
the three-year exclusion is reasonable.
Under section 1156(a) of the Act, evidence of Petitioner's
violations of her professional obligations is highly probative on
the issue of whether a given length of the exclusion is proper.
Evidence of past wrongdoing by a party tends to be an important
predictor of that party's propensity for engaging in similar
conduct in the future. The Act is not punitive in nature. It is
intended only to provide a remedy against possible wrongful conduct
by a party in the future.
I have already discussed Petitioner's intransigence,
misunderstanding of her professional obligations, and unreasonable
defense of her own practices. All such evidence indicates a strong
likelihood that Petitioner will continue to place Medicare
beneficiaries and Medicaid recipients unnecessarily in high-risk
situations. Petitioner has not voluntarily cut back or given up
any area of her practice. Tr. at 585. She rejected the CAPs
proposed by the PRO because she wished to maintain her current
volume of practice and could not afford the time to be away. Tr.
at 547. Some period of exclusion is necessary because Medicare
beneficiaries and Medicaid recipients need to be protected from the
risk of harm Petitioner is likely to create for them.
The PRO recommended that Petitioner be excluded from the Medicare
and Medicaid programs for a period of 10 years. I.G. Ex. 16 at 9.
The I.G. directed and imposed an exclusion of only three years.
I.G. Ex. 25 at 3. In arriving at the period of exclusion, the I.G.
had considered factors that included the severity of the offense,
the availability of other physicians in the area, and any problems
the Medicare carrier or intermediary may have had with Petitioner.
Id. at 4. The I.G.'s findings under those factors are in accord
with the facts of record.
I have considered also Petitioner's arguments concerning her
honesty and good intentions, her willingness to charge less than
other area physicians, her long history of practice in the
community, her view that she is irreplaceable, her having
approximately 4000 active patient charts in her practice (50
percent of which are for Medicare and Medicaid patients), her
having never been sued for malpractice until she delivered Amanda,
the limited number of other physicians in the area, and her desire
to help lower health care costs for the American people. See,
e.g., Tr. at 580; I.G. Ex. 17; P. letter dated January 3, 1994. 29/
I have noted Dr. Henderson's testimony concerning the compassion,
care, and understanding Petitioner has shown to her elderly
patients. Tr. at 448 - 49. He expressed the opinion that her
patients need kindness, compassion, and understanding from her;
that the human understanding element she provides may be as
critical to the caring of some elderly patients as lab tests; that
she is willing to make a house call in the middle of the night and
in situations where the patient would receive no care at all were
she not there. Id. I have no reason to doubt the sincerity of
Petitioner's beliefs in arguing for mitigation. Nor do I have
reason to doubt the general accuracy of Dr. Henderson's
observations.
I find that these factors contribute to the reasonableness of a
three year exclusion for Petitioner. Absent the foregoing
considerations, the 10-year exclusion recommended by the PRO would
appear to be more appropriate for remedying the types of problems
encountered in Amanda's case and in the other 13 patients' cases.
In limiting the exclusion to three years, I am recognizing those
points in Petitioner's favor -- her being a long-time practitioner,
the nonmedical needs of some patients, the unique accommodations
she makes for patients who cannot visit her office, and the good
Petitioner has done for her patients over the past four decades.
However, it would be unreasonable to further reduce the three-year
exclusion by attributing additional weight to the factors
identified by Petitioner.
Containing or lowering health care costs for the benefit of
society, for example, is a worthy goal expressed by Petitioner. It
does not, however, suffice for remedying Petitioner's inability or
unwillingness to meet professionally recognized current standards
of care. Section 1156 of the Act is not cast in terms of having
physicians cut costs for the Medicare and Medicaid programs by
eliminating medically necessary and appropriate procedures for
patients, or by adopting the view that the quality of treatment
makes no difference to those patients who are of advanced age or
seriously ill. While program providers should deliver services
economically, they must still deliver services when and to the
extent medically necessary, and of a quality which meets
professionally recognized standards of health care. Section
1156(a)(1), (2) of the Act.
Similarly, Petitioner's compassion, understanding, and willingness
to care for her patients on house-calls cannot completely offset
the serious health risks created by Petitioner's deficient medical
knowledge base. I am without the authority to limit Petitioner to
treating only those patients who need nothing beyond her
expressions of compassion, kindness, and understanding. Without
authorizing an exclusion of reasonable duration, I cannot provide
adequate protection to those Medicare beneficiaries and Medicaid
recipients whose lives may depend on their receiving appropriate
diagnostic tests or up-to-date therapeutic interventions.
As for Petitioner's argument that the population of Garnett needs
more (not fewer) doctors, I conclude from Petitioner's proposal to
have another doctor proctor her practice that at least one other
area doctor has the time to take on additional patients. The
three-year exclusion will not prevent Petitioner from treating
patients who are not in either the Medicare or the Medicaid
programs. No area doctor has testified that he will be unwilling
to treat more Medicaid or Medicare patients if Petitioner is
excluded. In addition, the evidence in this case shows that
Anderson County Hospital has an emergency room. I have been given
no reason to doubt that the hospital's emergency room has the
capability for, or has made suitable provisions for, treating those
acutely ill patients who go there, without regard for whether such
patients have their own private physicians as well.
I have considered the issue of whether Petitioner also has caused
actual injury to Amanda in deciding that a three-year exclusion is
appropriate. The possibility that Amanda suffers from problems not
of Petitioner's creation does not warrant further reducing the
exclusion. In discussing the period of exclusion, there was no
finding by the I.G. or the PRO that damage was actually done by
Petitioner. The I.G.'s notice, for example, stated only:
In the one instance cited, your treatment presented an
imminent danger to the health, safety, or well-being of the
[Medicaid] recipient involved or placed the recipient unnecessarily
in a high-risk situation.
I.G. Ex. 25 at 4 (emphasis added). The significance of this
conclusion, which is supported by a preponderance of the evidence
of record, is neither nullified nor outweighed by the possibility
that genetic defects or prenatal injuries may have caused
additional problems for Amanda.
In addition to protecting the programs and their beneficiaries and
recipients in the interim, an exclusion of three years will afford
Petitioner a meaningful opportunity to improve her medical
knowledge base and conform her treatment to the quality level
specified by section 1156(a) of the Act. Because Petitioner said
50 percent of her practice was taken up by Medicare and Medicaid
patients (Tr. at 580), Petitioner is likely to have more free time
during the three-year exclusion. If she wishes, she may use her
free time over the three-year period to accomplish at her own pace
what she was unwilling to undertake in the six months of intensive
retraining suggested by the PRO's CAPs. An exclusion of less than
three years is unlikely to provide Petitioner with adequate time
for maintaining her non-Medicare and non-Medicaid practice while
she attempts (if she wishes) those changes that may result in the
I.G.'s granting her reinstatement into the programs after the
exclusion expires.
For all the foregoing reasons, I find a three-year exclusion to be
reasonable.
_____________________________
Mimi Hwang Leahy
Administrative Law Judge
1. "Gross and flagrant" is defined at 42 C.F.R. 1004.1 as a
violation which represents "an imminent danger to the health,
safety or well-being of a Medicare beneficiary or places the
beneficiary unnecessarily in high-risk situations." Section
1156(a)(2) of the Act specifies that the health care provided to
Medicare beneficiaries must be "of a quality which meets
professionally recognized standards of health care."
2. Unless the context indicates otherwise, hereinafter I refer
to all programs from which Petitioner has been excluded, other than
Medicare, as "Medicaid."
3. My prehearing order reflects the I.G.'s prior
representations that, on behalf of the Secretary of the Department
of Health and Human Services, the Peer Review Organization (PRO)
had been continuously conducting a 100 percent intensified
prepayment review of the care provided by Petitioner to her
Medicare and Medicaid patients. See, e.g., I.G. letter to me dated
April 15, 1993. At hearing, counsel for the I.G. informed me that
the foregoing description was not totally accurate. Transcript
(Tr.) at 30. The PRO's medical director testified that, except for
a brief period during 1987, the PRO conducted its intensified
reviews only after Petitioner had discharged her Medicare patients
from the hospital; in some instances, the reviews were conducted
after Petitioner had received reimbursement from the Medicare
program. Tr. at 30.
4. The parties filed posthearing briefs, together with proposed
findings of fact and conclusions of law, and reply briefs.
Petitioner then withdrew her posthearing brief and requested that
her "First Amended Dr. Stevens' Post Hearing Memorandum of Law" be
substituted. The I.G. did not object, and I permitted the
substitution. I refer to the documents submitted by the parties as
follows: I.G.'s exhibits as I.G. Ex(s). (number) at (page).
Petitioner's exhibits as P. Ex(s). (number) at (page). I.G.'s
posthearing brief as I.G. Br. at (page). Petitioner's posthearing
brief as P. Br. at (page).
5. This portion of the preamble to the regulations states in
relevant part:
In rendering medical judgments, the [PRO] must apply as
principal points of evaluation and review, professionally developed
norms of care, diagnosis, and treatment based on typical patterns
or practice within the geographic area served by the organization.
6. At hearing, I heard testimony from three witnesses called by
the I.G.: Dr. James E. Allen, Dr. Joseph Schwarting, and Dr. Hal
Copple. All these witnesses were highly qualified practitioners
with credentials not disputed by Petitioner. Dr. Allen is the
principal clinical coordinator for the PRO, the Kansas Foundation
for Medical Care (KFMC). He was also the medical director of KFMC
at the time it recommended to the I.G. that Petitioner be excluded
from the Medicare and Medicaid programs. Dr. Schwarting is a
board-certified family practitioner. Tr. at 124. Dr. Copple
practices office-based pediatrics with full hospital privileges for
providing intensive care to children and infants. Tr. at 265.
7. Dr. Allen expressed his opinion as follows:
Dr. Stevens' medical knowledge is not of sufficiently current
character that she can provide reasonably up-to-date care that
meets currently recognized standards. Tr. at 39.
8. Petitioner raised the issue of the hospital employees' bias
in the context of their potential liability in a malpractice
lawsuit filed on Amanda's behalf. P. Br. at 14 - 15. The
possibility of bias due to a lawsuit is overly speculative where,
as here, Petitioner and Dr. Henderson confirmed during hearing that
the employees raised their concerns, made recommendations, or took
independent actions contemporaneous to the time Petitioner was in
charge of Amanda's care.
9. I do not imply that the I.G. has attempted to support her
authority to impose and direct an exclusion with evidence beyond
that reviewed by the PRO in this case. The I.G.'s experts confined
their analysis of Petitioner's conduct to the records that were
reviewed by the PRO. In those instances where physicians have
reviewed the patient records in issue as experts for the parties
and not as the PRO's agents, I have been mindful of the physicians'
roles in deciding whether or to what extent I should give weight to
their independent expert explanations, comments, or clarifications
of the patient records also reviewed by the PRO.
10. Dr. Henderson testified that a fetal heart monitor was
located in the delivery room of Anderson County Hospital, but he
was the only area doctor who had used it during deliveries. Tr. at
406, 452.
11. The Apgar score reflects the total score given for the
newborn's functions, such as heart rate, breathing, and reflexes;
the newborn is given a rating in five specified categories with
each category having a potential of two points. Tr. at 290 - 91.
12. "After birth the changeover from fetal circulation to
pulmonary oxygenation may have been hampered by the meconium and
other amniotic fluid that apparently was in the lungs initially.
This however probably would not have been a problem had the baby
been vigorous baby at birth. In other words, a term baby, born
vertex with meconium staining, very seldom has trouble clearing his
lungs." P. Ex. 10 at 2.
13. I did not find credible Petitioner's contention that
someone told her Amanda's Apgar score had increased to "4" at five
minutes after birth. Tr. at 341 - 42, 496 - 97. Petitioner could
not state the source of this information, and there is no
documentation of this score. Id. Moreover, Petitioner had alleged
at another time that Amanda's Apgar score was close to "10" at 10
minutes after birth. I.G. Ex. 4 at 1. Petitioner has used these
same types of self-serving excuses before to justify other
deficiencies in her care of patients.
14. Petitioner stated that the RT called Dr. Henderson to
countermand her refusal to transfer Amanda. Tr. at 520, 521. Dr.
Henderson testified that a nurse called him under established
procedures because the nurse thought there was a quality of care
problem in Petitioner's treatment of Amanda; later, the phone was
handed to the RT to speak with Dr. Henderson. Tr. at 363, 431 -
34.
15. Hypoglycemia pertains to a deficiency of glucose
concentration in the blood, which may lead to nervousness,
hypothermia, headache, confusion, and sometimes convulsions and
coma. Dorland's Pocket Medical Dictionary (22d ed.). Dr. Copple
likened the dangers of hypoglycemia to cardiac arrest. Tr. at 356.
16. Petitioner cited "temperature" as an indicator of suspected
sepsis. I.G. Ex. 14 at 70 - 71. However, she did not associate
Amanda's increasing temperature with possible infection. See Tr.
at 502. She told the PRO that no test was done for infection
because she thought Amanda had been in a sterile environment that
included sterile meconium, and, therefore, Petitioner had no reason
to think Amanda had an infection. I.G. Ex. 14 at 49; I.G. Ex. 4 at
2. There is no proof that infants cannot become infected because
they have been in a sterile environment. At the very least,
Petitioner should have been aware that, after birth, Amanda was no
longer in a sterile environment.
17. Dr. Copple was of the opinion that at this juncture, after
having saved the baby's life, a rural practitioner would have
anticipated a number of problems and decided to transfer the baby
to another facility better suited to care for those potential
problems. Tr. at 297 - 98.
18. An oximeter is a photoelectric device for determining
oxygen saturation of the blood. Dorland's Pocket Medical
Dictionary (22d ed.).
19. At one point during the hearing, I misidentified as
Petitioner's exhibit 17 a document that was withdrawn by
Petitioner. Tr. at 19. Petitioner withdrew proposed exhibit 16
after an extended discussion of the I.G.'s objection to it. Tr. at
17 - 19. I admitted Petitioner's proposed exhibit 17. Tr. at 21.
20. The I.G.'s determination was that, in Amanda's case,
Petitioner's treatment presented "an imminent danger to the health,
safety, or well-being" of Amanda, or had placed Amanda
"unnecessarily in a high-risk situation." I.G. Ex. 25 at 4. In
these proceedings, the I.G. has not asked for any finding of actual
harm done by Petitioner.
21. I incorporate by reference my discussions at pages 23 to 35
of my Ruling Finding Serious Risk.
22. Usually, the PRO evaluates a physician's work by sampling
20 to 25 percent of cases. Tr. at 29. Intensified reviews occur
after the PRO identifies a specific number or type of problem in
the sampled cases. Id. For an intensified review, the PRO
normally reviews 100 percent of a physician's cases during a given
period. Id. Since 1987, such reviews have been done
posttreatment, that is, retrospectively by the PRO after the
patients have been discharged from hospitals. Tr. at 30. However,
for a brief period during 1987, there were some reviews that were
done by nonphysician employees of the PRO who called a hospital
during a patient's stay to inquire about the patient's status. Id.
23. At hearing and in her brief, Petitioner has erroneously
referred to a "Level IV" rating in reliance upon earlier dated
documents from the PRO. P. Br. at 18; Tr. at 49 - 53. The PRO
revised the rating to a "Class II" after having considered
Petitioner's explanations. I.G. Ex. 28 at 11.
24. There is no scientific basis for Petitioner's opinion. The
miniscule amount of blood needed for ABGs cannot possibly cause
anemia. Tr. at 213.
25. Petitioner's letter fails to explain why she felt the
Medicare program would not have paid for this beneficiary's
continued hospitalization due to illness. BH had been hospitalized
for only three days when she was sent home in a condition that even
Petitioner described as "definitely ill." I.G. Ex. 31 at 44.
26. The information lacking from the patient's records is
consistent with Petitioner's contention that she performed the
orchiectomy upon being asked to do so by the patient. Tr. at 568.
27. "Significant adverse effect" means either "unnecessary
prolonged treatment, complications, or readmission," or "patient
management which results in anatomical or physiological impairment,
disability, or death." I.G. Ex. 39 at 9.
28. The PRO issued its notice during the period Petitioner was
under proctoring by Dr. Henderson and was not creating any quality
of care problems. I.G. Ex. 41 at 27. However, for this and the
following case, the patients were discharged from the hospital
prior to January 1, 1991 when the proctoring began; therefore,
these were not among the patients whose care was overseen by Dr.
Henderson under the CAP.
29. Because this letter was received in our office and served
on counsel for the I.G. during the period I set aside for the
filing of posthearing briefs, I have considered the letter as the
equivalent of a posthearing brief from Petitioner.