Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of:
Bernard J. Burke, M.D., DATE: December 8, 1995
Petitioner,

Docket No. C-94-380
Decision No. CR406

“ve

The Inspector General.

DECISION

On May 3, 1994, the Inspector General (I.G.) issued a
letter (Notice) advising Petitioner that, effective May
23, 1994, he would be excluded from participation in
Medicare and State health care programs for five years,
pursuant to authority under section 1156 of the Social
Security Act (Act).!' The I.G. based the determination to
exclude Petitioner on a recommendation made by Island
Peer Review Organization, Inc. (IPRO), the peer review
organization (PRO) for the State of New York.

The Notice stated that IPRO based its recommendation that
Petitioner be excluded for five years on its
determination that, in a substantial number of cases,
Petitioner failed substantially to comply with the
obligations imposed on him by section 1156(a) of the Act.
This determination derived from IPRO's findings that in
20 cases, Petitioner substantially violated the
obligations imposed on him by section 1156(a) of the Act.

The Notice stated that, after careful review of all the
evidence of record, including rebuttal information
submitted by Petitioner, the I.G. agreed with IPRO's

' “state health care program" is defined by
section 1128(h) of the Act to cover three types of
federally financed health care programs, including
Medicaid. Unless the context indicates otherwise, I use
the term "Medicaid" hereafter to represent all State
health care programs from which Petitioner was excluded.
2

findings that, in a substantial number of cases,
Petitioner substantially violated his obligations under
section 1156(a) of the Act. Of the 20 cases identified
by IPRO, the I.G. agreed with IPRO's findings in 14
cases. The I.G. determined that 11 of the 14 cases
involved violations of the obligation to provide care of
a quality that meets professionally recognized standards
of health care’ and that three of the 14 cases involved
violations of the obligation to provide appropriate
evidence of medical necessity and quality in a form and
fashion as may be required.

Additionally, the I.G. determined that Petitioner has
demonstrated an unwillingness and an inability
substantially to comply with the obligations imposed on
him by section 1156(a) of the Act. The I.G. alleged that
this is demonstrated by the seriousness and multiplicity
of problems with Petitioner's care as identified by IPRO.

In addition, the I.G. stated that a corrective action
plan (CAP) established in 1989, and an education
intervention undertaken in 1990, had not altered
Petitioner's pattern of practice.’

2? A provider of care is obligated to assure that
items or services which he or she provides to Medicare
beneficiaries and Medicaid recipients are "of a quality
which meets professionally recognized standards of health
care." Act, section 1156(a)(2). For the sake of
brevity, I refer to these standards as "professionally
recognized standards of care", "professional standards of
health care", “professional standards of care" or
“professional standards." In addition, the conduct which
formed the basis of the exclusion occurred in 1991 and
the applicable professionally recognized standards of
health care are those which were in effect in 1991.
Unless the context indicates otherwise, I use the term
“professionally recognized standards of health care" to
refer to the standards in effect in 1991.

3 The I.G. alleged also in the Notice that 18
additional cases, while not being used as the basis on
which the exclusion is imposed, demonstrate Petitioner's
continuing inability to meet his obligations under
section 1156(a). During a prehearing conference held by
me on September 7, 1994, counsel for the I.G. stated that
the I.G. would not rely on these 18 additional cases in
this proceeding. September 8, 1994 Order and Notice of
Hearing at 3 - 4. At the hearing, the I.G. reiterated

(continued...)
3

The Notice stated also that, in arriving at the
determination to exclude Petitioner for a period of five
years, the I.G. had considered specific factors in
accordance with 42 C.F.R. § 1004.90(d) .‘

Petitioner requested a hearing and the case was assigned
to me for hearing and decision. By letter dated August
31, 1994, the I.G. stated that the best evidence
available indicated that the population of the county in
which Petitioner practices medicine is less than 70,000.
Therefore, before an exclusion could be effected,
Petitioner was entitled to a preliminary hearing on the
issue of whether he poses a serious risk to the welfare
of program beneficiaries and recipients. Based on this,
the I.G. informed Petitioner that the I.G. was
reinstating Petitioner's eligibility to be reimbursed for
items and services provided to program patients,
retroactive to May 23, 1994.5

3 (...continued)
this position. The I.G. stated that, even though there
has been an ongoing review of Petitioner's medical
practice, the I.G. is not relying on any of the cases
which have been the subject of this ongoing review in
this proceeding. Transcript (Tr.) at 32 - 33. At the
hearing, I ruled that I will not make any inferences
based on the fact that there is an ongoing review of
Petitioner's medical practice, nor will I rely on any
evidence pertaining to any case which is the subject of
the ongoing review in reaching a decision on any issue
before me in this case. Tr. at 34.

* once the I.G. has determined that there is a
basis for an exclusion, she must consider the specific
factors contained in 42 C.F.R. § 1004.90(d) in
determining the appropriate length of the exclusion. The
I.G. is to consider these factors: (1) the
recommendation of the PRO; (2) the type of offense; (3)
the severity of the offense; (4) the previous sanction
record of the practitioner or other person; (5) the
availability of alternative sources of services in the
community; (6) any prior problems the Medicare carrier or
intermediary has had with the practitioner or other
person; (7) whether the practitioner or other person is
unable or unwilling to comply substantially with the
obligations; and (8) any other matters relevant to the
particular case.

5 Petitioner attached a copy of this letter to his
initial posthearing brief for my convenience.
4

I held a hearing in New York, New York, from February 14
through 16, 1995. The parties agreed that the hearing
should consolidate the taking of evidence as to the
issues of serious risk, the authority of the I.G. to
exclude Petitioner pursuant to section 1156 of the Act,
and the reasonableness of the length of the exclusion
which the I.G. imposed on Petitioner. The parties agreed
to address these issues also in posthearing briefs.

The parties submitted posthearing briefs, response
briefs, and reply briefs. In addition, I notified the
parties that I would take judicial notice of the Merck
Manual, an authoritative medical treatise, in considering
certain issues in this case. The parties submitted
supplemental briefs on the applicability of information
contained in the Merck Manual to issues in this case.

The I.G. did not offer any evidence pertaining to Case #
10, referred to at page four of the Notice, nor did the
I.G. make any arguments pertaining to this case in the
posthearing submissions. Accordingly, my decision is
based on the evidence and arguments pertaining to the 13
other cases referred to in the Notice.

I have considered carefully the applicable law, the
evidence adduced at the hearing, and the arguments raised
by the parties. I conclude that the I.G. proved that
authority exists under section 1156 of the Act to exclude
Petitioner from participation in Medicare and Medicaid.

I conclude also that the five-year exclusion is
reasonable. Lastly, I conclude that Petitioner poses a
serious risk to program beneficiaries and recipients
within the meaning of section 1156(b)(5) of the Act.

In order to allow time for receipt and implementation of
this decision, the exclusion will become effective 20
days after the date of this decision.

FINDINGS OF FACT AND CONCLUSIONS OF LAW (FFCLs)°

Petitioner's professional background

1. Petitioner graduated from Syracuse Medical School in
1943. I.G.'s Exhibit (I.G. Ex.) 6 at 6.

6 As a convenience to the parties, I have divided
my FFCLs into sections which are headed by descriptive
captions. The captions are not FFCLs, and they do not
alter the meaning of my FFCLs.
5

2. Petitioner has been licensed to practice medicine in
the State of New York since 1943. Tr. at 183 - 184.

3. Upon graduating from medical school, Petitioner was
an intern at Methodist Hospital in Brooklyn, New York.
Tr. at 184.

4. After completing his internship, Petitioner served in
the military. Following his military service, Petitioner
completed two years of postgraduate training in general
pathology at Methodist Hospital. I.G. Ex. 6 at 6; Tr. at
184.

5. Petitioner is not board-certified in any specialty.
I.G. Ex. 6 at 6.

6. Petitioner has practiced general medicine in Little
Falls, New York continuously from approximately 1947.
Tr. at 184 - 185.

7. Petitioner is affiliated with Little Falls Hospital
in Little Falls, New York. Tr. at 184.

Procedural history

8. The duties of a PRO under contract with the Secretary
of the United States Department of Health and Human
Services (the Secretary or DHHS) include reviewing the
professional activities of physicians for the purpose of
determining whether the quality of services that
physicians provide to program beneficiaries and
recipients meets professionally recognized standards of
health care. Act, section 1154(a) (1) (B).

9. In December of 1988, the Empire State Medical,
Scientific and Educational Foundation, Inc. (ESMSEF) was
under contract with the Secretary to be a PRO in the
State of New York. Petitioner's Exhibit (P. Ex.) 14.

10. On December 15, 1988, ESMSEF notified the I.G. that
Petitioner had grossly and flagrantly violated his
obligations under section 1156 of the Act and recommended
that Petitioner be permanently excluded. P. Ex. 14.

11. The I.G. determined that there was insufficient
evidence to support ESMSEF's recommendation. The I.G.
returned the case to ESMSEF without prejudice. P. Ex.
14.

12. On June 16, 1989, ESMSEF issued an initial sanction
notice advising Petitioner that it had made an initial
determination that Petitioner had failed to comply
6

substantially with his obligations under section 1156 of
the Act in 14 cases. ESMSEF offered Petitioner the
opportunity to provide additional information to ESMSEF
and to participate in a meeting with representatives of
ESMSEF. I.G. Ex. 7.

13. Petitioner met with representatives of ESMSEF on
August 17, 1989. Petitioner was represented by counsel
at this meeting. I.G. Ex. 8.

14. During the August 17, 1989 meeting, Petitioner and
ESMSEF agreed that Petitioner would participate in a CAP.
The CAP had three elements: (1) ESMSEF would review all
of Petitioner's hospital admissions for the previous
three-month period; (2) Petitioner would take a
continuing medical education (CME) course approved by
ESMSEF; and (3) Petitioner would improve the quality of
his documentation. I.G. Ex. 8, 9.

15. On approximately December 1, 1989, IPRO was awarded
the New York State PRO contract. As a result of this
contract, IPRO assumed responsibility for monitoring the
implementation of Petitioner's CAP. Tr. at 25 - 26; I.G.
Ex. 10.

16. By letter dated January 29, 1990, IPRO asked
Petitioner to report on his progress in complying with
the CAP requirement that he take a CME course. I.G. Ex.
10.

17. By letter dated March 29, 1990, IPRO acknowledged
that it had received Petitioner's response to its request
for information regarding Petitioner's CME compliance.
IPRO informed Petitioner that it would review all of
Petitioner's Medicare medical records for a period of
three months. P. Ex. 15.

18. By letter dated October 1, 1990, IPRO instituted an
educational intervention. IPRO asked Petitioner to
provide information regarding the educational program
established at Little Falls Hospital and stated that it
would evaluate the information to ascertain whether the
program met IPRO's educational intervention requirements.
I.G. Ex. 31 at 65.

19. By letter dated October 10, 1990, the administrator
of Little Falls Hospital provided information regarding
the hospital's efforts to fulfill IPRO's educational
intervention requirements for Petitioner. The hospital
administrator reported that the hospital had purchased
tapes produced by the Network for Continuing Medical
Education Program, that Petitioner was watching these
7

tapes, and that a hospital secretary would keep a record
of the tapes which Petitioner watched. I.G. Ex. 31 at
64.

20. By letter dated October 19, 1990, Petitioner agreed
to enter into the educational intervention program. I.G.
Ex. 14 at 3.

21. By letter dated January 18, 1991, IPRO informed
Petitioner that IPRO accepted the educational
intervention program that had been submitted. IPRO
requested Petitioner to submit documentation on a monthly
basis listing the CME programs he completed. I.G. Ex. 31
at 63.

22. Petitioner subsequently submitted to IPRO regular
reports on the CME tapes he watched and the CME lectures
and conferences he attended. I.G. Ex. 31.

23. On June 19, 1992, IPRO issued an initial sanction
notice advising Petitioner that it had made an initial
determination that Petitioner had failed to comply
substantially with his obligations under section 1156 of
the Act in 26 new cases. IPRO offered Petitioner the
opportunity to provide additional information to IPRO and
to participate in a meeting with representatives of IPRO.
I.G. Ex. 11.

24. By letter dated August 7, 1992, IPRO informed
Petitioner that its continuing review of Petitioner's
cases revealed additional cases in which Petitioner
failed to substantially comply with his obligations.
I.G. Ex. 14 at 1.

25. In view of the continuing deficiencies in
Petitioner's medical care identified by IPRO, IPRO made
the decision to withdraw its June 19, 1992 initial
sanction notice and to proceed directly to a second
sanction notice. I.G. Ex. 14 at 1, 4, I.G. Ex. 15 at 13.

26. On August 7, 1992, IPRO issued a second sanction
notice advising Petitioner that there was a reasonable
basis for determining that Petitioner had failed to
substantially comply with his obligations under section
1156 in a substantial number of cases. IPRO identified
24 cases which formed the basis for this determination.
IPRO offered Petitioner the opportunity to provide
additional information to IPRO and to participate in a
meeting with representatives of IPRO. I.G. Ex. 14.

27. By letter dated October 6, 1992, IPRO notified
Petitioner that it was adding another case to the 24
8

cases identified in the August 7, 1992 second sanction
notice. I.G. Ex. 15 at 2 - 12.

28. Petitioner met with representatives of IPRO on
November 10, 1992. Petitioner was represented by counsel
at this meeting. I.G. Ex. 6.

29. On December 18, 1992, IPRO's Board of Directors
voted to recommend to the I.G. that Petitioner be
excluded for five years. I.G. Ex. 1 at 2.

30. On January 26, 1993, IPRO issued a final sanction
notice advising Petitioner that it had determined that
Petitioner had failed to comply substantially with

his obligations in 23 cases and that it had recommended
to the I.G. that Petitioner be excluded for five years.
P. Ex. 16.

31. Ina letter to IPRO dated March 31, 1993, the I.G.
determined that IPRO failed to follow regulatory
requirements, because it had not provided Petitioner with
three notices and two hearings on the same cases. Based
on this procedural defect, the I.G. returned IPRO's
recommendation without prejudice. I.G. 1 at 2.

32. On June 4, 1993, IPRO issued a second sanction
notice advising Petitioner that it had reviewed the
additional information provided by Petitioner in response
to the August 7, 1992 notice, and that this information
did not modify IPRO's determination that there was a
reasonable basis to conclude that Petitioner has failed
to substantially comply with his obligations under
section 1156 in a substantial number of cases. IPRO
offered Petitioner the opportunity to provide additional
information to IPRO and to participate in a meeting with
representatives of IPRO. I.G. Ex. 2.

33. IPRO identified 20 cases which formed the basis for
its June 4, 1993 notice. All 20 of these cases were
identified also in the August 7, 1992 notice. I.G. Ex.
2.

34. Petitioner met with representatives of IPRO on
September 28, 1993. Petitioner was represented by
counsel at this meeting. I.G. Ex. 3.

35. On December 20, 1993, IPRO's Board of Directors
again voted to recommend to the I.G. that Petitioner be
excluded for five years. I.G. Ex. 1 at 10.

36. On January 13, 1994, IPRO issued a final sanction
notice advising Petitioner that it had determined that
9

Petitioner had failed to comply substantially with his
obligations under section 1156 of the Act in 20 cases and
that it had recommended to the I.G. that Petitioner be
excluded for five years. I.G. Ex. 1 at 4 - 8.

37. IPRO advised Petitioner that, within 30 days from
his receipt of the final sanction notice letter dated
January 13, 1994, he could submit to the I.G. any
additional information he had which could affect IPRO's
recommendation. I.G. 1 at 8.

38. On February 16, 1994, Petitioner submitted rebuttal
information to the I.G., which the I.G. considered as
part of the final exclusion determination in this case.
I.G. Ex. 31; Notice at 2.

39. On May 3, 1994, the I.G. advised Petitioner that the
I.G. accepted IPRO's determination that Petitioner had
substantially violated his obligations under section
1156(a) of the Act in a substantial number of cases.
Notice at 1.

40. The I.G. concluded that in 11 cases Petitioner had
failed to provide care that met professionally recognized
standards of health care. The I.G. concluded also that
in three cases Petitioner had failed to provide
appropriate evidence of medical necessity and quality in
a form and fashion as may be required. Notice at 9.

41. The I.G. concluded further that Petitioner
demonstrated an unwillingness and inability substantially
to comply with the obligations imposed by section 1156(a)
of the Act. Notice at 7.

42. The I.G. determined to exclude Petitioner from
participation in Medicare and Medicaid for five years,
pursuant to section 1156(b)(1) of the Act. Notice at 8,
10.

Right to a hearing

43. A party who is subject to an exclusion determination
pursuant to section 1156(b)(1) of the Act is entitled to
an administrative hearing. Act, section 1156(b) (4).

44, Petitioner's right to a hearing is a right to a de
novo hearing. Act, sections 1156(b)(4) and 205(b).

45. The exclusion imposed by the I.G. must be supported
by the preponderance of the evidence. S. Khalid Hussain,
M.D., DAB CR204 (1992).
10

The I.G.'s authority to impose an exclusion

46. A provider of care is obligated to assure that items
or services which he or she provides to program
beneficiaries and recipients are:

a. provided economically and only when, and to the
extent, medically necessary;

b. of a quality which meets professionally
recognized standards of health care; and

c. supported by evidence of medical necessity and
quality in such form and fashion and at such time
as may reasonably be required by a reviewing PRO in
the exercise of its duties and responsibilities.

Act, section 1156(a).

47. The Secretary, or her delegate, the I.G., may
exclude a provider where, based on the recommendation of
a PRO, she or the I.G. determines that the provider has,
in a substantial number of cases, substantially violated
his or her obligations under section 1156(a) of the Act,
and where that provider is unable or unwilling
substantially to comply with his or her statutory
obligations. Act, section 1156(b) (1).

Acts or omissions by Petitioner related to his
obligations under section 1156 of the Act on which the
I.G. based the termination to exclude Petitioner

Patient 031409’ (Discussion begins on page 42)

48. Patient 031409, a 73-year old female, presented to
Little Falls Hospital on July 29, 1991, with back and
shoulder pain that had lasted for several hours. I.G.
Ex. 16 at 9, 13.

49. The patient was admitted to the hospital for
observation, with admitting diagnoses of arteriosclerotic
heart disease, possible anginal syndrome, and diabetes
mellitus with diabetic retinopathy. I.G. Ex. 16 at 11.

7 fhe names of each of the patients involved in
this proceeding are reported in their medical records,
which are in evidence. However, as a courtesy tho these
patients, and out of respect for their privacy, I refer
to each of them by the number assigned to their medical
record.
11

50. A gallbladder sonogram was done to rule out
gallbladder colic as a cause of the patient's recurrent
pain. I.G. Ex. 16 at 10.

51. The sonogram of the patient's gallbladder revealed
evidence of cholelithiasis (gallstones) with thickened
gallbladder walls suggesting cholecystitis (gallbladder
infection). I.G. Ex. 16 at 59; Tr. at 39 - 40.

52. Petitioner's discharge diagnosis for this patient
was thoracic pain, probably secondary to
cholecystolithiasis. I.G. Ex. 16 at 7, 10.

53. Cholecystolithiasis is a term which refers to the
presence of gallstones and the thickening of the
gallbladder wall. Tr. at 409.

54. Professionally recognized standards of care for a
physician presented with a sonogram indicating possible
gallbladder disease would require the physician promptly
to order tests to determine the patient's complete blood
count (CBC), and levels of serum amylase, alkaline
phosphatase, bilirubin, and transaminase (also referred
to as SGOT). Tr. at 39, 43, 310 - 311, 315 - 316.

55. The CBC would show whether the patient's white blood
cell count was elevated, which might indicate ascending
cholangitis, that is, that the infection from the
gallbladder has traveled up the common bile duct, and is
in the liver. Tr. at 42 - 43.

56. Abnormal bilirubin and transaminase results would be
indicators of jaundice or liver damage. Tr. at 43.

57. The alkaline phosphatase level would indicate
whether there is an obstruction in the patient's common
bile duct. Tr. at 43.

58. The serum amylase would indicate whether the patient
is suffering from acute pancreatitis, which may be
associated with cholecystitis. Tr. at 43.

59. During the patient's July 29, 1991 hospitalization,
Petitioner did not order a CBC, nor tests to determine
levels of serum amylase, alkaline phosphatase, bilirubin,
or transaminase. See I.G. Ex. 16 at 2, 4.

60. Petitioner testified that he did not order the blood
tests for this patient because he concluded that the
sonogram results and his physical examination of the
patient, which did not reveal local abdominal pain, led
him to conclude that the patient's gallbladder disease
12

was chronic, rather than acute, and was not likely the
cause of her pain. Tr. at 334 - 335.

61. Petitioner did not note in the patient's medical
record his reasons for concluding that her gallbladder
disease was likely chronic and, thus, that there was no
need for additional laboratory tests. Tr. at 408. See
also I.G. Ex. 16.

62. Petitioner's failure to note in the medical record
his reasons for concluding that further laboratory tests
were unnecessary was not in accord with professionally
recognized standards of health care. Tr. at 405 - 407.

63. Petitioner's testimony that the patient's
gallbladder disease was not likely the cause of her pain
is inconsistent with his discharge diagnosis of thoracic
pain, probably secondary to cholecystolithiasis. I.G.
Ex. 16 at 7.

64. Petitioner's testimony that the patient's
gallbladder disease was not likely the cause of her pain
is inconsistent with his statement to IPRO on November
10, 1992, that the patient's pain was consistent with
gallbladder colic. I.G. Ex. 6 at 13.

65. Petitioner's expert testified that the patient had
no clinical symptoms referable to her gallbladder. Tr.
at 405.

66. The testimony of Petitioner's expert is entitled to
little weight because it is contradicted by the patient's
medical record and by Petitioner's statement to IPRO.

67. During a previous admission, on July 25, 1991,
Petitioner ordered a CBC and SGOT for this patient, the
results of which were within normal limits. In addition,
bilirubin results were negative. P. Ex. 48 at 1, 3; Tr.
at 339 - 340.

68. The test results for the July 25, 1991 admission do
not indicate that any tests were done to ascertain the
patient's serum amylase or alkaline phosphatase levels.
P. Ex. 48; Tr. at 341 - 342.

69. There is no indication in the patient's medical
record that Petitioner relied on the test results from
the July 25, 1991 admission in determining not to repeat
the tests done during the July 29, 1991 admission. I.G.
Ex. 16; Tr. at 342.
13

70. In his initial written response to IPRO, Petitioner
did not claim to have relied on test results from a

previous admission in deciding not to order tests during
the patient's July 29, 1991 admission. I.G. Ex. 16 at 4.

71. Petitioner's failure to cross-reference the
patient's previous admission leaves me with no basis to
conclude that her condition remained unchanged from the
previous admission.

72. Petitioner consulted a gastroenterologist regarding
the treatment of this patient. I.G. Ex. 16 at 20 - 21;
Tr. at 312.

73. The gastroenterologist's report does not mention
gallbladder disease as a possible diagnosis. Tr. at 312;
I.G. Ex. 16 at 21.

74. At the November 10, 1992 meeting with IPRO,
Petitioner stated that he recalled that he had consulted
the gastroenterologist before he defined gallstones.
I.G. Ex. 6 at 15.

75. At the hearing before me, Petitioner could not
recall whether he discussed the findings of the
gallbladder sonogram with the gastroenterologist. Tr. at
333.

76. A consulting gastroenterologist would be expected to
comment in the consultation report on the results of a
gallbladder sonogram if the consultant were aware of such
results. Tr. at 314.

77. It is more likely than not that the consulting
gastroenterologist was not aware of the results of this
patient's gallbladder sonogram when he dictated his
consultation report. Tr. at 312.

78. The fact that the consulting gastroenterologist did
not suggest a diagnosis of gallbladder disease in his
report did not relieve Petitioner of the duty to obtain
the required blood tests or, at a minimum, to discuss the
need for such tests with the gastroenterologist. Tr. at
313 - 315.

79. Petitioner's failure to obtain the patient's CBC,
and blood levels of serum amylase, alkaline phosphatase,
bilirubin, and transaminase during the July 29, 1991
admission was a substantial violation of his obligation
to provide care of a quality that meets professionally
recognized standards of health care.
14

Patient 031943 (Discussion begins on page 47)

80. Patient 031943, a 67-year-old female, was admitted
to Little Falls Hospital on August 27, 1991, with a
complaint of chest pressure. I.G. Ex. 17 at 13, 15.

81. The patient had a family history of stomach cancer.
I.G. Ex. 17 at 13.

82. The results of blood tests performed at the time
this patient was admitted to the hospital in 1991 met the
criteria for a diagnosis of anemia. I.G. Ex. 17 at 15;
Tr. at 77.

83. Physical examination at the time of admission
revealed the stools to be dark and to be "4+" for blood.
The "4+" result is strongly positive for bleeding. I.G.
Ex. 17 at 15; Tr. at 288 - 290.

84. On August 29, 1991, the patient was transfused with
two units of blood, in response to the anemia. I.G. Ex.
17 at 33; Tr. at 347.

85. On September 1, 1991, the stools were "+1" for
blood. This result indicated that the bleeding had
essentially stopped. I.G. Ex. 17 at 34; Tr. at 436 -
437.

86. On September 3, 1991, a colonoscopy was performed on
the patient. The colonoscopy examined the patient's
anus, rectum, colon and cecum. I.G. Ex. 17 at 31.

87. The consulting physician who performed the
colonoscopy diagnosed diverticulosis of the sigmoid
colon. No other lesion was identified. I.G. Ex. 17 at
31.

88. The patient was discharged on September 3, 1991.
Petitioner's final diagnosis was anemia secondary to
bleeding from a hiatus hernia. Petitioner based this
diagnosis on the fact that the patient had the same
condition approximately three years earlier. I.G. Ex. 17
at 4, 11 - 12; Tr. at 349 - 350.

89. At the time of discharge, Petitioner recommended
that the patient be observed over a period of time. In
addition, he instructed her to lose weight, to elevate
the head of her bed, and to take medication (Zantac and
Maalox). I.G. Ex. 17 at 12.

90. The presence of darkened stool suggests bleeding
from the upper gastrointestinal (GI) tract. The darkened
15

stool is caused by blood from the upper GI tract that has
been digested by bacteria in the gut. Tr. at 290, 412.

91. There are many possible causes of upper GI bleeding.
Tr. at 290.

92. Professionally recognized standards of care for a
patient with an unexplained upper GI bleed requires that
a physician perform either an endoscopy or an upper GI
series, provided that neither is contraindicated for the
patient. Tr. at 78 - 79, 290, 297.

93. An endoscopy (also known as an
esophagogastroduodenoscopy) is a diagnostic procedure
which involves placing a tube down the esophagus and then
passing it under direct vision into the stomach. It can
be used to rule out the presence of an ulcer, cancer of
the stomach or esophagus, gastritis in the stomach, or
esphogeal varices. Tr. at 81 - 83; I.G. Ex. 33.

94. An upper GI series involves the patient taking a
barium swallow followed by an x-ray. The upper GI series
is not as accurate as an endoscopy, but it is a viable
alternative for diagnosing the cause of an upper GI
bleed. Tr. at 83, 89 - 90, 291.

95. The patient did not have any contraindications for
either an endoscopy or an upper GI series. Tr. at 298.

96. Petitioner did not obtain an endoscopy or an upper
GI series in the course of evaluating the patient. I.G.
Ex. 17.

97. Petitioner's failure to obtain an endoscopy or an
upper GI series to investigate an upper GI bleed is a
substantial violation of professionally recognized
standards of care.

98. Petitioner's failure to obtain an endoscopy or an
upper GI series exposed the patient to the serious risk
of having a gastric malignancy go undetected and
untreated. It exposed her also to the serious risk of
rebleeding. Tr. at 292.

Patient 039837 (Discussion begins on page 53)

99. Patient 039837, an 89-year-old female, had been a
long-term patient in the chronic care ward of Little
Falls Hospital. On September 28, 1991, she was
transferred to the active floor of the hospital due to a
serious change in her condition. At the time of the
16

transfer, she had a temperature of 104, some cough, and
ongoing diarrhea. 1.G. Ex. 18 at 4, 11, 14, 16.

100. At the time of her initial examination, the patient
was very ill. Her skin was mottled, as if she was about
to die, and she was bathed in cold perspiration. She was
unresponsive. Tr. at 211 - 212.

101. Petitioner diagnosed her as being in a septic
state. He also diagnosed possible pneumonia or
enteritis, acute, with vascular collapse. I.G. Ex. 18 at
14.

102. Petitioner did not take a urine culture. However,
he did take blood and sputum cultures. I.G. Ex. 18 at 5.

103. Results of a chest x-ray taken on September 28,
1991 revealed a large amount of fluid in the patient's
right chest. I.G. Ex. 18 at 4, 48; Tr. at 213.

104. On September 28, 1991, Petitioner performed a
thoracentesis, a procedure that involves inserting a
needle in the chest cavity to remove the accumulation of
fluid. I.G. Ex. 18 at 12; Tr. at 95.

105. The thoracentesis was accomplished with difficulty,
since the patient could not sit up due to the fact that
she had no palpable blood pressure. In order to perform
the procedure, it was necessary for her to be placed with
her right side down and her head slightly elevated. I.G.
Ex. 18 at 4.

106. A follow-up chest x-ray was not taken until the day
following the thoracentesis. Tr. at 103, 215.

107. A chest x-ray taken on September 29, 1991 revealed
a pneumothorax, which is air in the chest cavity. The
bottom half of the patient's right lung was collapsed.
The upper lobe of the right lung adhered to the chest
wall. Tr. at 95, 215; I.G. Ex. 18 at 12, 49..

108. On October 1, 1991, a chest x-ray was taken which
revealed that the patient's right chest had again filled
up with fluid. Tr. at 217; I.G. Ex. 18 at 50.

109. On October 1, 1991, Petitioner performed a second
thoracentesis. A chest tube was inserted which drained
fluid for a few days. 1.G. Ex. 18 at 12; Tr. at 217 -
218.
17

110. As a result of the chest tube, the patient's lung
re-expanded and the pleural effusion decreased. I.G. Ex.
18 at 4, 51.

111. On October 4, 1991, the patient died. I.G. Ex. 18
at 13.

112. Professionally recognized standards of care require
a chest x-ray to be taken immediately after a
thoracentesis is performed. The reason for taking a
chest x-ray immediately after a thoracentesis is to
ascertain whether all the fluid is removed from the chest
and whether the thoracentesis damaged the lung. Tr. at
96, 466 - 467.

113. Petitioner's failure to obtain a chest x-ray
immediately after the September 28, 1991 thoracentesis
was a substantial violation of his obligation to provide
care in accordance with professionally recognized
standards of care.

114. Petitioner's delay in obtaining a chest x-ray after
the September 28, 1991 thoracentesis delayed diagnosis
and put the patient at serious risk for developing
complications related to her ability to breathe. Tr. at
96 - 99.

115. Professionally recognized standards of care require
a urine culture be taken of a patient who is in a septic
state. I.G. Ex. 18 at 5; Tr. at 462.

116. Petitioner admits that his failure to obtain a
urine culture was an oversight. I.G. Ex. 18 at 5.

117. Petitioner's failure to obtain a culture of this
patient's urine was a substantial violation of
professionally recognized standards of care for a septic
patient.

Patient 058705 (Discussion begins on page 59)

118. Patient 058705, a 73-year-old male, was admitted to
Little Falls Hospital on July 8, 1991, after having been
found lying on the floor of his apartment. I.G. Ex. 19
at 12 - 13.

119. At the time of admission, Petitioner noted that the
patient had blisters on his buttocks. Petitioner
attributed this to the fact that the patient had been on
the floor of his apartment for a considerable period of
time. I.G. Ex. 19 at 14, 25.
18

120. Examination revealed that the patient had a
considerable amount of dried feces around the rectum and
the patient's family reported that he had a history of
incontinence of the bowel. I.G. Ex. 19 at 16.

121. Petitioner stated in the admission report that the
patient's incontinence was probably explained by chronic
impaction. Petitioner stated also that the patient
probably had chronic organic brain syndrome. I.G. Ex. 19
at 17.

122. The nursing notes written on the date of admission
describe the patient's buttocks as reddened with skin
breakdown. I.G. 19 at 54.

123. On July 11, 1991, Petitioner's progress notes
indicated that the patient's cellulitis had gotten
smaller. The nursing notes of that date described the
patient's lesion on his left buttock as a yellow central
area surrounded by a red area six inches in diameter and
indicated that there was no drainage. I.G. Ex. 19 at 26,
60.

124. On July 12, 1991, the nursing notes reported that
the lesion on the left buttock was smaller and less red
than it had been on July 11, 1991. I.G. Ex. 19 at 62.

125. On July 15, 1991, the nursing notes reported that
the skin lesion was much smaller than it had been on July
12, 1991. The notes stated that it was a small open area
near a large white patch surrounded by a small red
margin. I.G. Ex. 19 at 68.

126. On July 16, 1991, Petitioner's progress notes
described the skin lesion as healing and indicated that
it was about six centimeters in size. The nursing notes
of that dated described the lesion as yellow with dry
skin at the margins. I.G. Ex. 19 at 26, 70.

127. On July 21, 1991, the nursing notes stated that the
skin lesion was healing and that it was clean with clear
edges. I.G. 19 at 80.

128. On July 22, 1991, the nursing notes described the
lesion as an open area with a small amount of yellow
drainage. I.G. Ex. 19 at 82.

129. On July 23, 1991, the nursing notes described a
small amount of red drainage. I.G. Ex. 19 at 84.
19

130. On July 24, 1991, the nursing notes stated that
there was no change in the patient's skin lesion. I.G.
Ex. 19 at 86.

131. On July 29, 1991, Petitioner's progress notes
indicated that the patient had an unhealed ulcer on his
buttock which was four centimeters in size. I.G. Ex. 19
at 27.

132. On July 30, 1991, the nursing notes stated that the
skin lesion appeared to be healing, and described it as
an open area. I.G. Ex. 19 at 98.

133. On July 31, 1991, the nursing notes described the
lesion as a dry, open area and indicated that the patient
did not complain of pain. I.G. Ex. 19 at 103.

134. On July 31, 1991, Petitioner telephoned an order
that the patient's skin lesion be treated with Neosporin,
a topical antibiotic. I.G. Ex. 19 at 24; Tr. at 261.

135. On August 2, 1991, the patient was discharged to
the County Home for ongoing care. I.G. Ex. 19 at 13, 15.

136. Petitioner's final diagnoses included cellulitis of
the buttock and decubitus ulcer. I.G. Ex. 19 at 10.

137. The patient's discharge instructions included
application of Neosporin ointment to the buttock. I.G.
Ex. 19 at 107.

138. The July 8, 1991 nursing notes indicated that the
nurses moved the patient from side to side at regular
intervals. The patient was ambulating by July 10, 1991,
and the nurses encouraged him to ambulate regularly after
that. The nurses applied "A&D" ointment repeatedly,
changed his linens when they were wet, and monitored his
eating throughout his hospital stay. I.G. Ex. 19 at 54 -
103.

139. A decubitus ulcer is an erosion or ulceration of
tissue that has been subjected to prolonged pressure.
Tr. at 255.

140. The stages of decubitus ulcer formation correspond
to tissue layers. The first stage consists of skin
redness that disappears on pressure. The second stage
shows redness, edema, and induration, at times with
blistering. In the third stage, the skin becomes
necrotic, with exposure of fat. In the fourth stage,
necrosis extends to the muscle. Further fat and muscle
necrosis characterizes the fifth stage. In the sixth
20

stage, bone destruction begins. lerck n (15th ed.
1987) at 2298.

141. This patient had an ulceration of tissue that was
caused by prolonged pressure. I.G. Ex. 19 at 14, 25.

142. This patient had a decubitus ulcer.

143. Professionally recognized standards of care require
an attending physician to initiate a written plan of care
to address skin conditions caused by prolonged pressure.
Tr. at 255, 272.

144, The only written documentation of a physician order
pertaining to the treatment of this patient's skin
condition was made on July 31, 1991, when Petitioner
telephoned an order for Neosporin. I.G. Ex. 19 at 24.

145. Petitioner admits, and I find, that this patient's
chart does not contain a written plan of care to address
the treatment of the patient's skin condition. Tr. at
486, 489 - 490.

146. Petitioner's failure to document a plan of care to
address this patient's skin condition is a substantial
violation of professionally recognized standards of care.

147. There is no indication in this patient's chart that
Petitioner instructed the nurses orally to take specific
measures to care for this patient's skin condition. I.G.
Ex. 19.

148. Petitioner's unsubstantiated testimony that he
initiated a plan of care orally to address this patient's
skin condition is not credible.

149. Petitioner's failure to initiate a plan of care
orally to address this patient's skin condition is a
substantial violation of professionally recognized
standards of care.

150. Petitioner was informed about this patient's skin
condition, and he participated in the treatment of it.
I.G. Ex. 19 at 24 - 27.

151. While the patient's skin condition did not heal
completely during the course of his hospital stay, there
were documented periods of improvement. At no point did
the condition progress to the stage where it affected
muscle and bone tissue. I.G. Ex. 19.
21

152. The fact that this patient was continually soiling
himself could hinder the quick healing of this patient's
skin condition. Tr. at 263, 580.

153. Dr. Kops' testimony that the care received by this
patient hampered the healing of his skin condition is not
persuasive. Tr. at 258, 262, 274.

154. The weight of the evidence fails to establish that
the patient suffered any adverse consequences as a result
of Petitioner's care of the patient's skin condition.

Patient 032141 (Discussion begins on page 67)

155. Patient 032141, a 70-year-old female, was admitted
to Little Falls Hospital on July 25, 1991. The patient's
chief complaint was intractable pain of the left lateral
thigh of two weeks' duration. I.G. Ex. 20 at 14 - 15.

156. The patient had a history of recurrent pains in the
abdomen and chest of an unknown etiology. In addition,
she had a history of a suspected dependency on
medication. I.G. Ex. 20 at 14 - 15.

157. A few days prior to admission, the patient had been
treated as an outpatient with injections of medication
that gave her relief from the pain for about an hour, and
then it recurred. I.G. Ex. 20 at 15.

158. Physical examination of the patient at the time of
admission revealed that the patient had point tenderness
at the insertion of the fascia lata into the greater
trochanter on the left side. I.G. Ex. 20 at 15.

159. At the time of admission, Petitioner again treated
the patient with injections of medication which gave the
patient relief from the pain for a short period before it
recurred. I.G. Ex. 20 at 15.

160. Petitioner diagnosed pain, left lateral thigh,
either trochanteric tendinitis with fascia lata syndrome
or diabetic neuropathy. I.G. Ex. 20 at 14.

161. Petitioner referred the patient to a physical
therapist. In a report dated July 26, 1991, the physical
therapist described the patient as having discomfort
during hip flexion and external rotation. I.G. Ex. 20 at
24.

162. During the course of the patient's hospital stay,
she was treated with a combination of ultrasound, moist
22

heat, a "TENS" unit, anti-inflammatory medication, and a
series of active exercises. I.G. Ex. 20 at 27.

163. Petitioner obtained a psychiatric consultation. In
a report dated July 30, 1991, the consultant opined that,
while the patient did not appear to suffer from any major
psychiatric illness, there was a possibility that the
patient's pain could be symptomatic of a major
depression. I.G. Ex. 20 at 22 - 23.

164. The patient was not examined by an orthopedist or
neurologist during the course of the hospital stay. In
addition, no x-rays or "CAT" scans were taken of the
patient's hip and thigh. Tr. at 643; I.G. Ex. 20.

165. The patient complained of intermittent pain
throughout her stay at the hospital. On August 1, 1991,
the day that she was discharged, she complained of pain
and became more comfortable after a new patch was applied
to the "TENS" unit. I.G. Ex. 20 at 42 - 56.

166. At the time of discharge, the patient was
independent in ambulation and was able to bear weight in
her left leg. Petitioner reported that the patient's
pain had improved during the hospital stay, but that it
had not completely resolved. I.G. Ex. 20 at 13, 27.

167. The patient was discharged with instructions to
take medication, and she was advised to see Petitioner
for a follow-up examination. I.G. Ex. 20 at 13, 62.

168. The principal diagnosis at the time of discharge
was left trochanter tendinitis with fascia lata syndrome.
I.G. Ex. 20 at 8.

169. On August 4, 1991, the patient again was admitted
to the hospital with the complaint of severe pain in the
left thigh. I.G. Ex. 20 at 80.

170. The patient was injected with medication in the
tender area of the left trochanteric area. The pain
remained intractable and she was admitted to the hospital
for care and possible additional diagnostic procedures.
I.G. Ex. 20 at 80.

171. At 9:00 p.m. on the day the patient was admitted to
the hospital, the patient had achieved complete relief of
her pain. The following morning, the patient did not
have any pain, and she was discharged that day. I.G. Ex.
20 at 80, 95.
23

172. During the second hospital admission, no x~rays or
"CAT" scans were taken, and no orthopedic or neurologic
consultations were obtained. Tr. at 645 - 646; I.G. Ex.
20.

173. On August 7, 1991, the patient was readmitted to
the hospital with the same complaint. I.G. Ex. 6 at 118.

174. The patient's pain symptoms improved or completely
diminished prior to each discharge. I.G. Ex. 20.

175. The patient's physical examination and her response
to Petitioner's injections is suggestive of the diagnosis
of tendinitis. Tr. at 631 - 632.

176. Tendinitis is a condition known to produce
intermittent pain, and a person suffering from this
condition might continue to experience intermittent pain
even after discharge from a hospital setting. Tr. at 636
- 638.

177. Petitioner properly considered the patient's
history of fixating on pain and her history of possible
drug dependency in making the decision to manage her
condition conservatively, without extensive diagnostic
testing. Tr. at 638 - 640.

178. The record is devoid of expert medical opinion
evidence establishing that professionally recognized
standards of care require that this patient should have
been free of pain for a specific period of time before
she was discharged from the hospital.

179. The record is devoid of expert medical opinion
evidence establishing that this patient's readmission to
the hospital for the same complaint within a few days
establishes that a prior discharge had been premature.

180. The record is devoid of expert medical opinion
evidence establishing that professionally recognized
standards of care required Petitioner to perform
radiologic tests and to obtain additional consultations
under the circumstances of these hospital admissions.

181. The I.G. did not prove that Petitioner's treatment
of this patient violated professionally recognized
standards of care.

Patient 060460 (Discussion begins on page 73)

182. Patient 060460, a 76~year old male, was brought by
ambulance to the emergency room at Little Falls Hospital
24

on August 22, 1991, following a sudden episode of
weakness, slurred speech, and confusion. I.G. Ex. 22 at
11 - 12.

183. He was admitted for observation with a preliminary
diagnosis of a transient ischemic attack (TIA). I.G. 22
at 13.

184. A TIA is a cerebral dysfunction of vascular origin,
which usually lasts between several minutes and several
hours with no permanent neurological damage. I.G.'s
Brief at 39.

185. Patients who experience a TIA are at risk for
developing another TIA or a stroke. Tr. at 495.

186. A common cause of TIAs is the formation of
arteriosclerotic plaques in the carotid arteries. Tr. at
111, 610.

187. Arteriosclerotic plaques may narrow the carotid
arteries, restricting blood flow to the brain. Tr. at
111.

188. Patients who have stenosis, or narrowing, of the
carotid artery of more than 25 percent have an increased
risk of both stroke and coronary heart disease. I.G. Ex.
34 at 4.

189. Patients who have suffered TIAs related to stenosis
of the carotid arteries may be treated medically, using
anticoagulant drugs, or surgically, by carotid
endarterectomy, to remove the arteriosclerotic plaques.
P. Ex. 50 at 1 - 2, P. Ex. 51; Tr. at 111.

190. Conn's Current Therapy is a professionally
recognized medical text. Tr. at 117.

191. The risk of stroke in symptomatic patients with
stenosis of the carotid arteries of 70 percent or more is
reduced by carotid endarterectomy. P. Ex. 50 at 3, P.
Ex. 51.

192. Physical examination alone does not yield precise
information about carotid artery function or blood flow
to the brain. Tr. at 499 - 500.

193. Professionally recognized standards of health care
in diagnosing carotid artery stenosis require a physician
to first assess the status of the carotid arteries non-
invasively, using Doppler ultrasound. P. Ex. 51; Tr. at
113, 134, 500.
25

194. If the Doppler ultrasound indicates a potentially
serious lesion, that is stenosis of more than 30 percent,
professionally recognized standards require that the
patient be further evaluated. P. Ex. 51.

195. The preferred method for accurately measuring the
degree of stenosis of a patient's carotid arteries is
direct cerebral angiography, an invasive procedure that
involves injecting dye into the carotid arteries, and
which itself involves approximately one percent risk of
stroke. P. Ex. 50 at 3, P. Ex. 51; Tr. at 113, 496, 500.

196. Carotid endarterectomy is clearly indicated only
for those patients whose carotid arteries are at least 70
percent occluded, as demonstrated by angiography. P. Ex.
51.

197. It is not in accord with professionally recognized
standards of health care to recommend carotid
endarterectomy on the basis of Doppler ultrasound studies
without confirming the degree of stenosis by angiography.
P. Ex. 51; see also P. Ex. 50 at 3 - 4.

198. Petitioner did not order a Doppler ultrasound of
this patient's carotid arteries.

199. Petitioner failed to meet his obligation to provide
care in accordance with professionally recognized
standards by failing to order a Doppler ultrasound for
this patient.

200. Petitioner treated this patient by prescribing the
medical treatment appropriate for a patient with a
diagnosis of TIA who was not a surgical candidate. Tr.
at 136.

201. Petitioner testified that this patient did not wish
to consider surgical treatment under any circumstances.
Tr. at 494, 500 - 501.

202. Professionally recognized standards of health care
require the physician to note in the medical record a
patient's refusal of surgical treatment. Tr. at 616.

203. Petitioner failed to document in the medical record
that this patient did not wish to consider surgical
treatment. Tr. at 616.

204. Petitioner's failure to document that this patient
refused surgical treatment violated Petitioner's
obligation to provide care in accordance with
professionally recognized standards of health care.
26

205. Petitioner's testimony that this patient refused
surgical treatment is not completely consistent with his
written response to IPRO, in which he stated: "On the
basis of the man's clinical presentation, I could not
suggest to this man that he have an operation on his
carotid system." I.G. Ex. 22 at 4.

206. Because Petitioner failed to obtain a Doppler
ultrasound of this patient's carotid arteries, Petitioner
could not meaningfully have advised the patient of the
risks and benefits of carotid endarterectomy surgery.

207. Petitioner violated his obligation to provide
health care that meets professionally recognized
standards by ruling out surgery for this patient without
obtaining the results of a Doppler ultrasound of the
patient's carotid arteries.

Patient 060717 (Discussion begins on page 76)

208. Patient 060717, a 69-year-old male, was admitted to
Little Falls Hospital on December 2, 1991 with the
complaint of acute dyspnea. I.G. Ex. 23 at 11.

209. At the time of the patient's admission to the
hospital, Petitioner diagnosed him as having
arteriosclerotic heart disease with acute severe
pulmonary edema, severe chronic obstructive pulmonary
disease, and mild renal insufficiency. I.G. Ex. 23 at
11.

210. At the time of his admission, the patient had been
taking Capoten. On December 3, 1991, the patient's
medication was switched from Capoten to Vasotec. Vasotec
and Capoten are both medications which are ACE
(angiotensin converting enzyme) inhibitors which are used
in the treatment of hypertension and congestive heart
failure. I.G. Ex. 23 at 19, 41; Tr. at 243 - 245.

211. Petitioner prescribed five milligrams of Vasotec
twice a day on December 3, 1991. He increased the dosage
later that day to five milligrams in the morning and 10
milligrams at night. I.G. Ex. 23 at 19; Tr. at 244.

212. On December 4, 1991, Petitioner increased the
dosage again to ten milligrams twice daily, which was
continued until the day of discharge. I.G. Ex. 23 at 20;
Tr. at 244.

213. The patient was discharged on December 9, 1991.
Petitioner's progress notes of this date state that the
patient was to go home with a prescription for five
27

milligrams of Vasotec to be taken twice a day. I.G. Ex.
23 at 21, 25; Tr. at 244 - 245.

214. Petitioner did not document his discharge
instructions on his physician order sheet. I.G. Ex. 23
at 21.

215. A discharge summary which was dictated by
Petitioner on December 30, 1991, 21 days after the
patient was discharged from the hospital, indicates that
the patient was discharged with a prescription for five
milligrams of Capoten to be taken twice a day. I.G. Ex.
23 at 14.

216. The patient's chart does not include a discharge
instruction sheet containing written instructions that
had been given to the patient prior to his discharge from
the hospital. Tr. at 248, 251.

217. Petitioner's testimony that he discharged the
patient with oral instructions to take five milligrams of
Vasotec twice a day is credible. Tr. at 503 ~ 504, 506.

218. The I.G. did not prove that the patient was
discharged with instructions to take the higher dosage of
ten milligrams of Vasotec twice a day. I.G. Ex. 23.

219. The I.G. gave Petitioner sufficient notice that she
was alleging that Petitioner inaccurately documented his
treatment of the patient on the discharge summary, and
that this documentation error was a basis for the I.G.'s
determination to exclude Petitioner. Notice at 5.

220. Petitioner admits that the discharge summary
incorrectly states that this patient was discharged on
five milligrams of Capoten twice a day. Tr. at 509 -
510.

221. Petitioner admits that the discrepancy between his
December 9, 1991 progress notes and his December 30, 1991
discharge summary might be confusing to a physician
attempting to treat the patient if he was readmitted to
the hospital. Tr. at 507.

222. Petitioner's failure to accurately document his
discharge instructions on the December 30, 1991 discharge
summary was a substantial violation of his obligation to
provide care which is supported by the necessary
documentation.

223. The I.G. did not prove that professionally
recognized standards of care require Petitioner to write
28

the discharge instructions in the progress notes and on
the physician order sheet. Tr. at 623 - 624.

224. The I.G.'s contention that Petitioner's
documentation of his treatment of this patient is
deficient because the patient's chart does not include a
written discharge instruction sheet is not encompassed by
the allegations in the Notice. Notice at 5.

225. The absence of a written discharge instruction
sheet in this patient's chart is not a valid basis for
Petitioner's exclusion in this case.

226. The I.G.'s contention that Petitioner's
documentation of his treatment of this patient is
deficient because Petitioner failed to explain the
reasons for the changes in the patient's cardiac
medication is not encompassed by the allegations in the
Notice. Notice at 5; Tr. at 246 - 247, 249.

227. The I.G.'s allegation that Petitioner failed to
explain the reasons for the changes in the patient's
cardiac medication is not a valid basis for Petitioner's
exclusion in this case.

Patient 030053 (Discussion begins on page 82)

228. Patient 030053, a 76-year old male who suffered
from diabetes mellitus, was brought by ambulance to the
emergency room at Little Falls Hospital on December 27,
1991, after an episode of coma induced by his overdosing
himself with 70 units of insulin that morning. I.G. Ex.
24 at 12 - 13.

229. The normal range for blood sugar values is 80 to
120 mg/dL. Tr. at 140.

230. The emergency medical technicians who transported
the patient had found that his blood sugar was 33 mg/dL,
and they administered 50 percent Dextrose. I.G. Ex. 24
at 10.

231. By the time the patient arrived at the emergency
room, the patient's blood sugar was 180 mg/dL, and he was
alert and oriented. I.G. Ex. 24 at 10.

232. The patient suffered another episode of
hypoglycemia in the emergency room and was admitted to
the hospital for observation. I1.G. Ex. 24 at 12.

233. On December 27, 1991, the nursing staff checked the
patient's blood sugar at 4:30 p.m., when his blood sugar
29

level was 77; at 9:30 p.m., when his blood sugar level
was 26; and at 9:45 p.m., when his blood sugar level was
57. I.G. Ex. 24 at 32 - 33.

234. On December 27, 1991, at 10:15 p.m., the nursing
staff noted a telephone order from Petitioner to "change
IV solution to Dextrose 10% -- run at rate to obtain
blood sugar above 80 then slow IV down to KVO [keep vein
open] for the n[ight}." I.G. Ex. 24 at 14.

235. On December 27, 1991, at 10:30 p.m., the nursing
staff noted that the patient's blood sugar level was 108.
I.G. Ex. 24 at 32 - 33.

236. There is no record that the patient's blood sugar
level was monitored again until 6:30 a.m. on December 28,
1991, when the patient's blood sugar level was 134. I.G.
Ex. 24 at 32 - 33, 35.

237. Professionally recognized standards of health care
require that the attending physician specify a rate for
administering IV Dextrose to a hypoglycemic patient. Tr.
at 137, 139.

238. Professionally recognized standards of health care
require the attending physician to establish a plan of
care for a hypoglycemic patient that would specify
regular monitoring of the patient's blood sugar. I.G.
Ex. 3 at 119 - 120; Tr. at 138.

239. Petitioner's orders for this patient failed to
specify a rate of administration for IV Dextrose and
failed to specify regular monitoring of the patient's
blood sugar levels.

240. Even if Petitioner's order to administer 10 percent
Dextrose at a KVO rate once blood sugar was normal was
sufficient, the fact that this patient's blood sugar was
not monitored between 10:30 p.m. on December 27, 1991 and
6:30 a.m. the next morning would represent care that
failed to meet professionally recognized standards.

241. Petitioner's failure to order a rate for
administering the IV Dextrose, and his failure to order
regular monitoring of the patient's blood sugar, are
substantial violations of his obligation to provide care
of a quality that meets professionally recognized
standards of health care.
30
Patient 030344 (Discussion begins on page 85)

242. Patient 030344, a 76-year-old male, was admitted to
Little Falls Hospital on August 15, 1991 with complaints
of dyspnea, weakness, and intermittent chest pain.
Petitioner diagnosed auricular fibrillation. I.G. Ex. 25
at 7, 13, 15.

243. On August 20, 1991, Petitioner ordered that the
patient be placed on Heparin, an intravenous
anticoagulant medication. I.G. Ex. 25 at 11, 19; Tr. at
277.

244. On August 25, 1991, the patient was discharged.
I.G. Ex. 25 at 9.

245. Petitioner's handwritten progress notes, dated
August 25, 1991, and his typewritten progress notes,
dated September 18, 1991, indicate that Petitioner
discharged the patient with instructions to follow a low
sodium diet, to take various medications (Vasotec, Lasix,
and Isosorbide), and to come in for a follow-up visit.
I.G. Ex. 25 at 11, 25.

246. The discharge instruction sheet, prepared by the
nurse who discharged the patient, repeated the
instructions given by Petitioner in his progress notes.
I.G. Ex. 26 at 76.

247. Professionally recognized standard of care requires
the attending physician to write his discharge
instructions in the medical chart. The nurse who
discharges the patient will include the attending
physician's instructions in the discharge instruction
sheet which is given to the patient. Tr. at 285 - 287.

248. Neither Petitioner's handwritten nor his
typewritten progress notes indicate that the patient was
instructed to take Coumadin, an anticoagulant medication,
at the time that he was discharged. The discharge
instruction sheet, prepared by the nurse in response to
Petitioner's progress notes, did not include an
instruction for the patient to take Coumadin. I.G. Ex.
25 at 11, 25, 76; Tr. at 277.

249. After IPRO reviewed this chart and requested a
response, Petitioner stated for the first time that the
patient was treated with Coumadin as an outpatient after
his discharge from the hospital. I.G. Ex. 25 at 4.

250. Petitioner admits that his failure to document his
intent to treat this patient with Coumadin on discharge
31

was a documentation error. Petitioner's Brief at 56 -
57.

251. Petitioner's failure to document his intent to
prescribe Coumadin to this patient on discharge is a
substantial violation of his obligation to provide
necessary documentation of his care.

Patient 039069 (Discussion begins on page 88)

252. Patient 039069, a 76-year-old male, was admitted to
Little Falls Hospital on September 22, 1991, complaining
of vertigo and nausea. I.G. Ex. 26 at 9 - 10.

253. Petitioner's initial examination of this patient
revealed that he had generalized arteriosclerosis with
acute episodes of vertigo, mild organic brain syndrome,
and arteriosclerotic heart disease with ongoing auricular
fibrillation and cardiac prominence. I.G. Ex. 26 at 9.

254. Petitioner noted in his progress notes that the
patient had been under the care of several cardiac and
orthopedic physicians, but there is no mention of any
contact with these physicians during the patient's
admission. I.G. Ex. 26 at 9.

255. A CBC was performed on the patient approximately
seven days before admission. A CBC was not performed at
the time of admission. I.G. Ex. 3 at 23; I.G. Ex. 6 at
82.

256. A CBC was necessary at admission. I.G. Ex. 26 at
4, I.G. Ex. 6 at 182 - 183, I.G. Ex. 30 at 11.

257. Petitioner did not indicate on the chart that he
did not perform a CBC and he did not explain why a CBC
was not performed on admission. In addition, the results
of the prior CBC are not documented on the patient's
chart. I.G. Ex. 26.

258. Petitioner's failure to document that he did not
perform a CBC on this patient at the time he was
admitted, his failure to explain why a CBC was not
performed on admission, and his failure to document the
results of the CBC performed prior to admission is a
substantial violation of his obligation to provide the
necessary documentation of care. I1.G. Ex. 26, I.G. Ex.
29 at 7.
32
Patient 037680 (Discussion begins on page 91)

259. Patient 037680, an 85~year-old female, was admitted
to Little Falls Hospital on August 21, 1991. Her chief
complaint was that she was having hallucinations.
Although the patient had some insight into her problem,
the hallucinations had a considerable reality to the
patient and disturbed her. I.G. Ex. 27 at 5 - 6.

260. The patient had a brother who lived nearby. I.G.
Ex. 27 at 5.

261. At the time of the patient's admission to the
hospital, Petitioner diagnosed organic brain syndrome
with hallucinatory and delusional state. I.G. Ex. 27 at
5.

262. Physical examination of the patient revealed
evidence of bilateral arthritis of both knees, and that
the right knee was acutely inflamed. I.G. Ex. 27 at 6.

263. From August 21, 1991 through August 23, 1991, the
patient alternated between being disoriented and being
lucid. At times, she did not realize that she was in the
hospital, and, at other times, she was oriented and gave
appropriate responses. I.G. Ex. 27 at 56, 59 - 61.

264. On August 23, 1991, Petitioner performed an
arthrocentesis of the patient's right knee. I.G. Ex. 27
at 61; Tr. at 149, 223.

265. Arthrocentesis is an invasive procedure which
involves inserting a needle into the patient's knee and
withdrawing fluid. I.G. Ex. 27 at 61; Tr. at 149 ~ 151,
223.

266. Petitioner's progress notes describe the procedure
and its results as follows: "Tapped Rt [right] Knee -
Old Blood - Hemarthrosis." I.G. Ex. 27 at 19.

267. Within 45 minutes after the arthrocentesis was
performed, the patient began to cry and stated that she
saw snakes coming out of a box containing needles. The
patient stated that, although she knew the snakes were
not real, she still could see them. The patient reported
seeing snakes the next day. I.G. Ex. 27 at 61, 65.

268. During the course of the patient's hospital stay,
she was treated with insulin, and her hallucinations
improved. At the time of her discharge on September 10,
1991, the patient had achieved mental equilibrium. I.G.
Ex. 27 at 25, 26.
33

269. Professionally recognized standards of health care
require that a physician obtain informed consent prior to
performing an invasive procedure. Tr. at 150.

270. Arthrocentesis is an invasive procedure. Tr. at
149.

271. Professionally recognized standards of health care
regarding the process for obtaining informed consent
require the physician to explain the purpose of the
procedure, how it will be performed, the possible
benefits of the procedure, and the possible complications
of the procedure. The patient should be given the
opportunity to ask questions of the physician. Tr. at
300.

272. The patient's chart does not contain a consent form
for the arthrocentesis. I.G. Ex. 27.

273. If the patient is incapable of understanding
information pertaining to the procedure, it should be
explained to an adult who is the closest relative to the
patient. Consent for performing the procedure should be
obtained from that individual. Tr. at 151.

274. Petitioner did not make any attempt to contact the
patient's brother in order to obtain consent. Tr. at
231.

275. The fact that the patient was delusional does not
necessarily mean that she was incapable of giving
informed consent for the arthrocentesis. Tr. at 561.

276. Petitioner's assertion that the patient gave
informed consent orally is not corroborated by the
evidence. Petitioner's Brief at 70.

277. Petitioner's self-serving assertion that he
obtained informed consent is not credible.

278. Petitioner did not obtain informed consent from
this patient.

279. The right of a patient to be fully informed about
the treatment being recommended and to refuse that
treatment is a basic right which is codified in the New
york State Patients' Bill of Rights. Tr. at 563; I.G.
Ex. 27 at 111.

280. Petitioner's failure to obtain informed consent
from this patient shows a disturbing indifference to the
fundamental rights of patients and it is a substantial
34

violation of Petitioner's obligation to provide care that
meets professionally recognized standards of care.

281. Professionally recognized standards of care require
a physician to document that oral consent has been
obtained. Tr. at 563 - 565.

282. Even if Petitioner had obtained valid consent
orally, Petitioner's failure to document that such
consent was obtained is a substantial violation of his
obligation to document the quality of his care.

283. Hemarthrosis is a diagnostic term indicating that
blood was found in the knee joint. Tr. at 160, 557.

284. Petitioner diagnosed the patient's medical
condition based on his observations of the fluid
withdrawn from the patient's knee and he documented this
diagnosis in the patient's chart. I.G. Ex. 27 at 19.

285. Professionally recognized standards of care require
a physician to write a procedure note for invasive
procedures, such as arthrocentesis, performed at bedside.
The procedure note should contain a comprehensive
description of the indication for the procedure, the
procedure itself, and the results. Tr. at 160 - 161, 301
- 302.

286. Petitioner's August 23, 1991 entry in the chart
documents that arthrocentesis was performed and that old
blood was obtained, but it does not describe the
procedure and the results in sufficient detail to comport
with professionally recognized standards of care. Tr. at
160 - 161.

287. Petitioner substantially violated a professionally
recognized standard of health care by failing to document
adequately the procedure performed on this patient.

288. Professionally recognized standards of care require
that fluid withdrawn from a knee in the course of
arthrocentesis should be sent for laboratory analysis.
Tr. at 162 - 163.

289. Petitioner failed to prove that the fluid withdrawn
from this patient's knee had degenerated to the point
that sending it for a laboratory analysis would yield
meaningless results.

290. The purpose of sending the withdrawn fluid to a
laboratory for analysis is to obtain information
35

necessary to reach a final and complete diagnosis. Tr.
at 163.

291. While hemarthrosis was a properly documented
diagnosis based on the available information immediately
following the arthrocentesis, it is not a final or
complete diagnosis based on all tests that should have
been performed.

292. Petitioner's discarding the withdrawn fluid without
obtaining the necessary tests to make a final diagnosis
is a substantial violation of professionally recognized
standards of care.

Patient 034026 (Discussion begins on page 103)

293. Patient 034026, a 75-year old female, was admitted
to Little Falls Hospital on July 24, 1991 with a
diagnosis of renal colic. I.G. Ex. 28 at 8 - 11.

294. A laboratory test conducted on July 24, 1991
indicated that this patient had a blood glucose level of
232 mg/dL, an abnormally high result. I.G. Ex. 28 at 12.

295. Another blood test (SMA 18) was ordered on July 26,
1991. I.G. Ex. 28 at 21.

296. The results of that blood test are not recorded in
the patient's medical record. I.G. Ex. 28.

297. This patient was discharged from the hospital on
July 26, 1991. I.G. Ex. 28 at 8.

298. Petitioner admitted that there was no follow-up
value for blood glucose in the patient's medical record.
I.G. Ex. 28 at 4.

299. Petitioner admitted that results of the follow-up
blood test should have been in the medical record. I.G.
Ex. 28 at 4; Petitioner's Brief at 91.

300. The I.G. did not prove that Petitioner's care of
this patient represented a quality of care violation.

301. Petitioner's failure to document the follow-up
blood test result represents a substantial violation of
his obligation to provide necessary documentation of the
quality of his care.
36

Petitioner's substantial violations of his statutory
obligations in a substantial number of cases

302. A provider commits a substantial violation of his
or her statutory obligations under section 1156(a) ina
substantial number of cases where the pattern of care he
or she provides is inappropriate, unnecessary, does not
meet professionally recognized standards of care, or is
not supported by necessary documentation of care as
required by a PRO. 42 C.F.R. § 1004.1(b).

303. The I.G. proved that Petitioner engaged ina
pattern of care that is inappropriate, unnecessary, did
not meet professionally recognized standards of care, or
was not supported by necessary documentation as required
by IPRO.

304. The I.G. proved that Petitioner substantially
violated his obligations under section 1156(a) in a
substantial number of cases.

Petitioner's inability and unwillingness

305. The I.G. proved that Petitioner has demonstrated an
unwillingness and lack of ability substantially to comply
with his obligation to provide care in accordance with
his obligation under section 1156(a) of the Act.

The remedial need for an exclusion

306. The remedial purpose of an exclusion imposed
pursuant to section 1156 of the Act is to protect the
welfare of program beneficiaries and recipients from
providers who are untrustworthy to provide health care of
the requisite quality.

307. The I.G. proved that Petitioner is an untrustworthy
provider of care.

308. A five-year exclusion is reasonable in this case.

Serious Risk

309. The I.G. proved that Petitioner is a serious risk
within the meaning of section 1156 of the Act.
37

RATIONALE

I. The I.G. has authority to exclude Petitioner under
section 1156(b)(1) of the Act.

a. Section 1156 of the Act imposes obligations on
health care providers.

The I.G. excluded Petitioner pursuant to section

1156(b) (1) of the Act. The I.G.'s authority to impose an
exclusion under section 1156(b)(1) derives from a PRO's
determination and recommendation that a party be
excluded. In any hearing conducted under section

1156(b) (1), the administrative law judge must determine
whether the PRO's recommendation is in accord with one of
the statutory grounds on which an exclusion
recommendation may be based.

Section 1156(a) of the Act imposes three professional
obligations on health care practitioners who provide
items or services to program beneficiaries and
recipients. These are that the health care will be: (1)
provided economically and only when, and to the extent,
medically necessary; (2) of a quality which meets
professionally recognized standards of health care; and
(3) supported by evidence of medical necessity and
quality in such form and fashion and at such time as may
reasonably be required by a reviewing PRO in the exercise
of its duties and responsibilities. Section 1156(b) (1)
provides that a PRO may recommend that a health care
provider be excluded if the PRO determines that the
provider has either failed in a substantial number of
cases to comply substantially with any of these three
obligations, or if the provider has grossly and
flagrantly violated any of these obligations in one or
more instances.

In this case, IPRO based its exclusion recommendation to
the I.G. on its conclusion that Petitioner had ina
substantial number of cases substantially violated his
statutory obligations under section 1156(a)(1) of the
Act. The I.G. accepted IPRO's conclusion.

Section 1156(b)(1) states that, in order to exclude a
provider based on a recommendation by a PRO, the
Secretary (or the Secretary's delegate, the 1.G.) must
find that the party has demonstrated either an inability
or an unwillingness substantially to comply with the
obligations to provide care consistent with the
requirements of section 1156(a). In this case, the I.G.
found that Petitioner was unable and unwilling to comply
38

substantially with the obligations imposed on him by
section 1156(a) of the Act.

Section 1156(b) (4) of the Act provides that a provider
who is subject to an exclusion determination pursuant to
section 1156(b)(1) is entitled to an administrative
hearing. This section expressly confers on excluded
providers those rights to a hearing which inure to
parties under section 205(b) of the Act. Section 205(b)
provides for a de novo hearing. Thus, parties excluded
pursuant to section 1156(b)(1) are entitled to de novo
hearings. My obligation in conducting a de novo hearing
under sections 205(b) and 1156(b)(1) on the issue of the
I.G.'s authority to exclude a provider is to allow each
party to the hearing the opportunity to offer evidence
concerning the sufficiency of the facts on which a PRO's
recommendation and the I.G.'s ultimate determination are
based.

The Act provides that, in discharging their duties, PROs
must apply professionally developed norms of care,
diagnosis, and treatment, based upon typical patterns of
practice within the geographic areas served by such
organizations. Act, section 1154(a)(6)(A). On its face,
this section does not apply specifically to PROs'
discharge of their duties under section 1156 of the Act.
However, it does appear to establish a general obligation
for PROs to use professionally recognized standards of
health care of either national recognition or of a unique
local character in discharging their statutory duties.

It is evident from this language that professionally
recognized standards of health care in a given medical
specialty constitute a consensus among the physicians
practicing that specialty about how items or services
should be provided.

The Act's requirements are mirrored in regulations
adopted by the Secretary. Regulations define
professionally recognized standards of health care to be:

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.

The term "substantial violation in a substantial number
of cases" also has been defined by regulation. The term
means "a pattern of care that is inappropriate,
unnecessary, does not meet professionally recognized
39

standards of care, or is not supported by the necessary
documentation of care as required by a peer review
organization." 42 C.F.R. § 1004.1(b).

It is apparent from this regulatory definition that a
provider has violated his obligations under section
1156(a) of the Act in a "substantial number of cases" if
there is a showing that the provider has engaged in a
pattern of acts or omissions which substantially violate
his statutory obligations.

While it is clear that there must be a pattern of
substantial violations in order to meet this standard,
the regulatory definition does not explicitly define what
is meant by "substantial violation.” In the absence of
a regulatory definition of substantial violation, I give
the word substantial as used here its common and ordinary
meaning. "Substantial" is defined in the American
Heritage Dictionary, 2d College Edition, as "5.
Considerable in importance, value, degree, amount, or
extent . . ." I conclude from this common definition
that Congress intended the statutory term substantial
violation to mean any violation that is not minor or
trivial.

With these observations as background, I turn now to an
examination of the individual cases which the I.G. relies
on to support the I.G.'s allegation that Petitioner
substantially violated his obligations under section
1156(a) in a substantial number of cases.

b. Petitioner committed substantial violations of
his obligation to provide care in compliance with

section 1156(a) of the Act in a substantial number
of cases.

The I.G. Notice alleged that Petitioner substantially
violated his obligations under section 1156(a) of the Act
in 14 cases. During the course of this proceeding, the
I.G. withdrew one of the cases involving a violation of
the obligation to provide care of a quality that meets
professionally recognized standards of health care. Two
of the remaining 13 cases involve the same patient.
Thus, at issue in this proceeding are 13 cases involving
12 different patients. My decision on the issue of
whether Petitioner substantially violated his statutory
obligations in a substantial number of cases is based on
evidence which relates to IPRO's findings in these 13
cases.

The record shows that, on December 15, 1988, IPRO's
predecessor, ESMSEF, notified the I.G. that Petitioner
40

had grossly and flagrantly violated his obligations under
section 1156 of the Act and recommended that he be
permanently excluded. The I.G. concluded that there was
insufficient information to support this recommendation,
and returned the case to ESMSEF without prejudice. P.
Ex. 14.

On June 16, 1989, ESMSEF made an initial determination
that Petitioner had failed to comply substantially with
his obligations under section 1156 of the Act in 14
cases. Petitioner met with representatives of ESMSEF on
August 17, 1989 to discuss these 14 cases. During that
meeting, Petitioner and ESMSEF agreed that Petitioner
would participate in a CAP. I.G. Ex. 7, 8, 9.

On June 19, 1992, IPRO issued an initial sanction notice
advising Petitioner that it had made an initial
determination that Petitioner had failed to comply
substantially with his obligations under section 1156 of
the Act in 26 new cases. That notice, including the
cases referred to therein, was subsequently withdrawn by
IPRO. I.G. Ex. 11, 14, 15.

In reaching my decision on the issue of whether
Petitioner substantially violated his obligations in a
substantial number of cases, I have not considered the
cases which formed the basis for ESMSEF's December 15,
1988 recommendation, nor have I considered the 14 cases
which formed the basis for its June 16, 1989 initial
determination. In addition, I have not considered the 26
cases which formed the basis for IPRO's June 19, 1992
initial determination.

At the hearing, the I.G. offered the testimony of two
expert witnesses, Herbert Sperling, M.D. and Richard
Kops, M.D. Dr. Sperling, a board-certified surgeon, was
the chairman of the IPRO Sanction Committee from 1989 to
1992. I.G. Ex. 32. Dr. Kops is board-certified in both
gastroenterology and internal medicine. In addition, he
has been a consultant to IPRO for 11 years. Tr. at 239 -
241. Petitioner offered the testimony of Peter Nicholas,
M.D. Dr. Nicholas is board-certified in both internal
medicine and infectious diseases. Tr. at 366. All three
of these individuals are highly qualified practitioners
whose credentials were not disputed by the opposing
party.

The experts whom the I.G. called as witnesses at the
hearing have been involved in the review of Petitioner's
treatment of patients during the peer review process
conducted by IPRO. While Petitioner has not disputed the
professional qualifications of these witnesses, he
41

contends that IPRO is biased against him and that it is
"unwilling and unable to fairly assess" his practice.
Petitioner's Brief at 100 - 101. In particular,
Petitioner contends that Dr. Sperling has demonstrated a
bias against him. Petitioner's Brief at 97. In support
of these allegations, Petitioner points to parts of Dr.
Sperling's testimony in which he disagrees with Dr.
Sperling's opinions and characterization of the facts.
Petitioner argues that Dr. Sperling's bias, combined with
IPRO's “effort to taint the record with . . . unsupported
allegations and unilateral findings" against him, cast
doubt on IPRO's ability to assess his performance as a
medical practitioner in accordance with the requirements
of due process. Petitioner's Brief at 97.

I find that Petitioner's allegations of bias are not
supported by the record. Petitioner's attempt to
bootstrap his disagreement with the IPRO's conclusions
into allegations of bias is not persuasive. Petitioner
has not adduced credible evidence that Dr. Sperling or
other members of IPRO are biased against him. I find Dr.
Sperling and Dr. Kops to be knowledgeable and
dispassionate experts. By contrast, Petitioner's
assertion of bias is motivated by self-interest.

Moreover, Petitioner's argument that he was not provided
due process during the sanction process is unavailing.

In this regard, the exhaustive administrative record in
this case speaks for itself. Petitioner was offered many
opportunities to provide information that he thought
might convince the reviewers of the propriety of his
practices. He took advantage of these opportunities.
That IPRO did not make the desired determination is not
evidence that due process was denied.

I have evaluated the evidence pertaining to the I.G.'s
allegations. I do not find that the I.G. proved that
Petitioner violated his obligations under the Act in each
of the 13 cases. However, in every instance that I find
that the 1.G. proved that Petitioner violated an
obligation under the Act, I find also that the violation
is substantial. Moreover, I find that there are a
sufficient number of cases where Petitioner substantially
violated his obligations under the Act to prove that
Petitioner engaged in a pattern of acts or omissions
which substantially contravened his obligations under
section 1156(a) of the Act. The I.G. thus proved that
Petitioner substantially violated his obligations under
section 1156(a) in a substantial number of cases.

I will now proceed to an analysis of the 13 cases at
issue in this proceeding. For each case, I will quote
42

verbatim the PRO Findings, the I.G. Analysis, and the
I.G. Decision as set forth in the Notice. I will follow
this with my analysis of the evidence pertaining to that
case.

Patient 031409

PRO Findings: Failure to order complete blood
count, bilirubin, alkaline phosphatase, SGOT or
amylase on a patient.

[I.G.] Analysis; Patient admitted with chest and
abdominal pain. Sonogram shows cholelithiasis and
cholecystitis. Practitioner's failure to order
appropriate tests constituted a failure to evaluate
gallbladder and liver function in a patient with
diagnosed cholelithiasis.

[I.G.] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

My Analysis: This patient was a 73-year old female who
was admitted to Little Falls Hospital on July 29, 1991
complaining of pain in her back and shoulders. I.G. Ex.
16 at 9, 13. Because the patient had a history of heart
disease, it first appeared that her symptoms might be
related to her heart, but her pain did not respond to
nitroglycerin. I.G. Ex. 16 at 13; Tr. at 325. A
gallbladder sonogram was done to rule out gallbladder
colic as a cause of her pain. I.G. Ex. 16 at 10. The
sonogram revealed evidence of cholelithiasis (gallstones)
and suggested cholecystitis, an infection of the
gallbladder. I.G. Ex. 16 at 59; Tr. at 39 - 40.

Dr. Sperling testified that professionally recognized
standards of health care for treating a patient with
possible gallbladder disease would be to order blood
tests to determine the extent of the gallbladder
infection and to determine whether the liver and pancreas
were involved. Tr. at 39 - 43. This opinion was
corroborated by Dr. Kops. Tr. at 310 - 311, 315 - 316.
Neither Petitioner nor his expert testified that a
different professionally recognized standard was
applicable.* Therefore, I conclude that professionally

8 At the meeting with IPRO on November 10, 1992,
Petitioner stated that the tests would be appropriate for
a patient presenting purely with gallbladder colic. I.G.
Ex. 6 at 12. Petitioner's expert did not suggest that

(continued...)
43

recognized standards of health care required Petitioner
to order a CBC, and serum amylase, alkaline phosphatase,
bilirubin, and transaminase (SGOT) tests.

Petitioner acknowledges that he did not order these tests
during the July 29, 1991 hospitalization of this patient.
However, Petitioner offers a number of explanations as to
why such tests were not needed in this particular case.
First, Petitioner contends that the tests were not needed
because the patient's physical symptoms indicated that
her gallbladder disease was likely chronic, rather than
acute, and, in any event, she was not a candidate for
surgery. Petitioner's Brief at 4 - 5. Alternatively,
Petitioner contends that, if the tests were needed, they
had been done four days earlier, during a previous
admission, with normal results. Petitioner's Brief at 5
- 6. Finally, Petitioner contends that he consulted a
gastroenterologist, who did not recommend that the
patient undergo further gallbladder studies.

Petitioner's Brief at 7, 9. I do not find any of
Petitioner's explanations sufficient to overcome the
I.G.'s showing that Petitioner violated professionally
recognized standards of health care.

Petitioner contends that the CBC and enzyme studies were
not required, because his physical examination of the
patient did not reveal local tenderness or right upper
quadrant pain and she did not have fever or chills. Tr.
at 334 - 335. Petitioner contends that these physical
symptoms would have been present had the patient been
suffering acute gallbladder complications. In essence,
Petitioner is contending that whether the patient's
gallbladder disease is chronic or acute would dictate the
course of her diagnostic testing. While it can be argued
that a chronic gallbladder condition might not require
new diagnostic tests, this would occur only after those
tests had been done previously and ruled out the need for
more invasive treatment. However, nowhere in the medical
record does Petitioner document a conclusion that the
gallbladder sonogram and physical examination suggested
chronic, rather than acute, gallbladder disease, and
that, therefore, no further studies were warranted. Tr.
at 408.

8 (...continued)
the tests were not required in treating gallbladder
disease; instead, he opined that the tests were not
needed in this case because the patient did not have
clinical symptoms related to her gallbladder. Tr. at 404
- 405.
44

Moreover, the testimony of Dr. Nicholas goes even farther
than Petitioner's testimony. He opined that the tests
were unnecessary because the patient did not have any
clinical symptoms referable to her gallbladder. Tr. at
405. However, Dr. Nicholas' opinion is contradicted by
Petitioner's discharge note, which gives a final
diagnosis of thoracic pain probably secondary to
cholecystolithiasis. I.G. Ex. 16 at 10.° Further, at
the November 10, 1992 IPRO meeting, Petitioner stated
that the patient's pain was consistent with gallbladder
colic. I.G. 6 at 13. Therefore, Dr. Nicholas'
conclusion that the patient's pain was not referable to
gallbladder disease must be given little weight, since it
assumes findings and conclusions which are contrary to
those documented in the patient's medical record.

Similarly, Petitioner's testimony must be given less
weight when compared with his documented findings in the
patient's chart. As his note indicates, at the time he
discharged this patient, Petitioner apparently concluded
that her symptoms most likely were related to gallbladder
disease. Petitioner's discharge note and his statement
to IPRO were made closer in time to his treatment of the
patient than his testimony in these proceedings.
Therefore, I find the discharge note and the IPRO
statement more probative of his thinking at that time
than explanations he has produced after the fact which
are not supported by documentation in the medical record.
Therefore, I conclude Petitioner considered it likely
that this patient was suffering pain due to gallbladder
disease, yet did not order a CBC and enzyme tests, or
give any explanation for the absence of such tests, tests
that are required in accordance with professionally
recognized standards of health care.

Petitioner argues that, even if a CBC and other enzyme
tests were required, it was unnecessary to perform them
during this patient's July 29, 1991 admission because
similar tests done during a previous admission just four
days earlier were within normal limits. Petitioner
offered P. Ex. 48, which shows that during the July 25,
1991 admission, Petitioner ordered a CBC and SGOT for
this patient, the results of which were within normal
limits. In addition, the bilirubin results were
negative. P. Ex. 48; Tr. at 339 - 340. I conclude that
the fact that these tests were performed during a prior
admission does not justify Petitioner's failure to order

° The term "cholecystolithiasis" refers to the
presence of stones and the thickening of the gallbladder
wall. Tr. at 409.
45

them during the July 29, 1991 admission, for three
reasons. First, not all the required enzyme tests were
performed during the July 25, 1991 admission. Second,
there is no indication in the patient's medical record
that Petitioner relied on the earlier tests in ruling out
acute gallbladder disease as a cause of the patient's
pain. Third, since he did not reference her prior
admission, there is no way of determining whether her
gallbladder symptoms as of July 29, 1991 demonstrated a
worsening of her condition which would have required
additional diagnostic tests to determine whether her
condition had changed from chronic to acute, thus
requiring a change in her treatment.

As to the first point, I have concluded that
professionally recognized standards of health care would
require a physician to evaluate possible gallbladder
disease by ordering a CBC, as well as measuring
bilirubin, alkaline phosphatase, transaminase (SGOT), and
amylase levels. There is evidence that Petitioner
ordered the CBC, SGOT, and bilirubin during the July 25,
1991 admission. P. Ex. 48. There is no indication in
the record that Petitioner ever ordered tests to
determine this patient's alkaline phosphatase or amylase
levels. Id.; see also Tr. at 341 - 342. Therefore, even
if I were to conclude that Petitioner properly relied on
earlier test results in evaluating this patient, I would
find that the tests which Petitioner ordered during the
July 25, 1991 admission did not completely satisfy his
duty to provide care in accordance with professionally
recognized standards.

Second, Petitioner failed to document in the medical
record that he was relying on earlier test results as a
basis for ruling out acute gallbladder disease as a cause
of her pain. I.G. Ex. 16; Tr. at 342. As I previously
noted with regard to Petitioner's explanation that the
patient's clinical symptoms were more consistent with
chronic, rather than acute, gallbladder disease, the
absence of contemporaneous documentation suggests to me
that this explanation, too, may be an after-the-fact
justification. Petitioner's present reliance on the
previous test results, like his explanation of the
clinical symptoms, fails to account for his failure to
address this issue in his discharge summary.

Third, the absence of any discussion in Petitioner's
discharge summary of this patient's prior history with
gallbladder disease, including a description of her
earlier symptoms, does not provide me with any basis to
conclude that her symptoms of July 29, 1991 were merely a
continuation of her chronic symptoms and not a new acute
46

phase of her gallbladder disease. The latter condition
would require diagnostic studies that were not performed
by Petitioner during this patient's July 29, 1991
admission.

For these reasons, the test results from the patient's
July 25, 1991 admission do not alter my conclusion that
Petitioner violated his duty to provide care in
accordance with professionally recognized standards.

Finally, Petitioner argues that he did not violate
professionally recognized standards of health care
because he justifiably relied on the opinion of a
consulting gastroenterologist, who did not recommend
further diagnostic studies, other than endoscopy, nor
suggest a diagnosis of gallbladder disease. See I.G. Ex.
16 at 21. I conclude that Petitioner's consultation of a
gastroenterologist did not relieve him of the duty to
either order the required tests or, at a minimum, to
discuss the results of the patient's gallbladder sonogram
with the gastroenterologist. Dr. Kops opined that it
would be standard practice for a consulting
gastroenterologist to comment on the results of a
gallbladder sonogram, if the consultant were aware of
such results. Tr. at 314. Because the consultant's
report in this case did not mention the gallbladder
sonogram, the I.G.'s expert suggested that the consultant
may not have been aware of the results at the time he
dictated his report. Tr. at 312, 314 - 315. He stated
further that professionally recognized standards of
health care would require the family practitioner to
discuss the results of the sonogram with the specialist
and that they jointly would decide on the future course
of treatment for the patient. Tr. at 313. At the
hearing, Petitioner could not recall whether he discussed
the results of the sonogram with the consultant. Tr. at
333.'© Nor is there any reference to such communication
in the patient's medical record. I.G. Ex. 16. The
consultant's report does not say that gallbladder disease
was considered and ruled out, it simply does not mention
gallbladder disease. I find that the consultant's report
is insufficient to justify Petitioner's failure to order
further diagnostic studies.

For these reasons, I conclude that the I.G. proved that
Petitioner's failure to order a CBC, and blood levels of
serum amylase, alkaline phosphatase, bilirubin, and

10 At the November 10, 1992 IPRO meeting,
Petitioner stated, "I had Dr. Wong look at her I think
before I defined gall stones." I.G. Ex. 6 at 15.
47

transaminase during the July 29, 1991 admission was a
substantial violation of his duty to provide care of a
quality that meets professionally recognized standards.

Patient 031943

PRO Findings: Failure to properly evaluate and
follow-up a patient with abnormal laboratory
findings (anemia and blood in stools) and positive
family history for gastrointestinal malignancy.

[I.G.) Analysis: Patient admitted with chest

pressure. Patient had guaiac positive stool and a
Hgb of 8.2. Patient with hiatus hernia had
colonoscopy performed, which showed diverticulosis,
but not esophagogastroduodenoscopy or upper GI
{series}, for anemia requiring transfusion of two
units of blood.

[I.G.] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality

of care violation)

My Analysis: On August 27, 1991, this patient, a 67-
year-old female, was admitted to Little Falls Hospital
with complaints of chest pressure. I.G. Ex. 17 at 13,
15. The patient had a family history of stomach cancer.
I.G. Ex. 17 at 13. Blood tests met the criteria for a
diagnosis of anemia. I.G. Ex. 17 at 15; Tr. at 77. A
stool sample was noted as being 4+ for occult blood.

This result was strongly positive for bleeding. I.G. Ex.
17 at 15; Tr. at 288 - 290. On August 29, 1991 the
patient was transfused with two units of blood, in
response to the anemia. I.G. Ex. 17 at 33; Tr. at 347.

A second stool sample taken on September 1, 1991 produced
a +l result. I.G. Ex. 17 at 34. Petitioner's expert,
Dr. Nicholas, testified that a +1 occult blood test
result indicated that the patient's bleeding had
essentially stopped. Tr. at 436 - 437.

On September 3, 1991, Petitioner ordered the patient to
undergo a colonoscopy. The colonoscopy examined the
patient's rectum and lower GI tract. The doctor who
performed the procedure, Dr. Sodhi, determined that the
patient had diverticulosis of the sigmoid colon." I.G.

" Diverticulosis is "the presence of pouches or
sacs in the colon, which are caused by herniation of the
mucosa of the colon through the muscular layers of the
bowel wall." I.G.'s Brief at 18, footnote 3.

(continued...)
48

Ex. 17 at 31. Dr. Sodhi noted in his “Report of
Operation" that "[a]lthough the diverticulosis could
cause a GI hemorrhage, I don't [sic] it would give anemia
of this significance." Jd. Dr. Kops commented on Dr.
Sodhits statement. He suggested that the source of the
bleed in this case was not the diverticulosis, since
patients who bleed from diverticulosis generally bleed
with bright red blood and the patient here had a dark
stool. Tr. at 293. Petitioner acknowledged that,
although the patient had diverticulosis, her anemia was
relatively severe for that condition. Tr. at 348. He
testified that he did not obtain an endoscopy or upper GI
series to investigate the upper GI bleed because: 1) he
did not do any defensive medicine; and 2) based on this
patient's dislike of the colonoscopy, Petitioner
concluded she would not "enjoy" the endoscopic procedure
of her upper GI tract. Tr. at 348 - 349.

Petitioner diagnosed the cause of the patient's bleeding
as a hiatus hernia. He based this diagnosis on the fact
that she had this condition approximately three years
earlier.” I.G. Ex. 17 at 4, 11 - 12; Tr. at 349. On
the basis of his diagnosis and his determination that the
patient did not exhibit progressive anemia, Petitioner
discharged her with the recommendation that she be
observed over a period of time. Tr. at 349. In
addition, he told her to elevate the head of her bed,
take Zantac and Maalox, and lose weight. I.G. Ex. 17 at
12.

All three experts who testified about this particular
patient stated that the bleed in this case was most
likely due to an upper GI bleed. Dr. Kops testified that
the 4+ stool test and the presence of darkened stool was
indicative of bleeding from the patient's upper GI tract.
Tr. at 289 - 290. Dr. Sperling testified also that the
presence of dark stool signified upper GI tract bleeding.
Tr. at 78, 93. Dr. Nicholas stated that he believed that
the bleed had come from the upper tract and explained
that darkened stool is caused by blood from the upper GI
tract that has been digested by bacteria in the gut. Tr.
at 412 - 413. However, Petitioner did not order any
examination of the patient's upper GI tract and relied

..continued)

a A hiatus hernia is "a herniation of the
abdomen through the diaphragm." I.G.'s Brief at 18,
footnote 3.
49

instead upon the hiatus hernia diagnosis which he had
made approximately three years earlier. Tr. at 349 -
350.

Both Dr. Kops and Dr. Sperling testified that
professionally recognized standards of care for a patient
with an unexplained upper GI bleed are to perform either
an endoscopy or an upper GI series, provided that neither
was contraindicated for the patient. Tr. at 78 - 79,
290, 297. An endoscopy is a procedure used to examine
the upper GI region, and involves placing a tube down
through the esophagus and then passing it under direct
vision into the stomach. The procedure is also known as
esophagogastroduodenoscopy and can be used to rule out
the presence of an ulcer, cancer of the stomach or
esophagus, gastritis in the stomach, or esphogeal
varices. Tr. at 81 - 83; I.G. Ex. 33. Dr. Kops
testified that an endoscopy allows the clinician to
visualize the bleeding and, in most cases, spot the exact
source of the bleeding. Tr. at 291. An upper GI series
test involves the patient taking a barium swallow and
then having an x-ray taken. Tr. at 89. Both Dr.
Sperling and Dr. Kops indicated that the upper GI series
is not as accurate as the endoscopy, in that it cannot
identify gastritis, ulcerations, or small lesions, but it
is another: viable alternative for diagnosing an upper GI
bleed. Tr. at 83, 89 - 90, 291. Dr. Kops testified that
there were no contraindications for doing either an
endoscopy or an upper GI series on this patient, and both
he and Dr. Sperling stated that Petitioner's failure to
rule out upper GI tract bleeding with an upper GI workup
was a digression from professional standards of care.

Tr. at 79 - 84, 298.

In support of the argument that professionally recognized
standards of care dictate that an endoscopy or upper GI
series should be used to diagnose an upper GI bleed, the
1.G. relied on Harrison's Principles of Internal
Medicine. I1.G.'s Brief at 23. However, Petitioner
contended, through his expert Dr. Nicholas, that there is
considerable controversy about the role of routine
endoscopy in upper GI bleeding. Tr. at 417. Dr.
Nicholas opined that, based on a study showing no
increase in the number of further hospital admissions,
surgeries, or death for patients who did not have an
endoscopy, and who were treated only with antacid
therapy, endoscopy should not be a routine procedure in
patients with upper GI tract bleeding that ceases during
50

treatment." Tr. at 417 - 418. Dr. Nicholas testified
that since the bleeding in this case had essentially
stopped, as evidenced by the +1 occult blood test result,
an endoscopy was not necessary.

I do not find Petitioner's reliance on this controversy
about the efficacy of endoscopy in evaluating the source
of GI bleeds to be persuasive. The presence of a
controversy relating to the need for endoscopy does not
justify the conclusion that endoscopy examinations or
upper GI x-ray series should not be done when upper GI
bleeding occurs which ceases after the initial bleeding.
Moreover, Dr. Nicholas acknowledged that, despite the
existence of the controversy "some people [physicians]
do endoscopies for all upper GI bleeds." Tr. at 424.
Furthermore, Petitioner has failed to demonstrate that
the existence of the controversy in 1991 altered
professionally recognized standards then in effect to do
endoscopic or upper GI x-ray examinations.

Petitioner did not offer any evidence to prove that he
relied upon the controversy cited by his expert in making

8 The "Routine Early Endoscopy in Upper-
Gastrointestinal-Tract Bleeding" study relied on by Dr.
Nicholas indicates that an endoscopy is useful if the
patient experienced prior episodes of bleeding or if the
presence of a malignant disease is possible. P. Ex. 53
at 4-5.

Even if we were to accept Dr. Nicholas' assertion and
find that the standards of care do not require an
immediate endoscopy for a patient presenting with an
upper GI bleed that ceases during treatment, this case
falls within an exception to the standards. The study on
which Petitioner relies states that there are situations
where an endoscopy may be necessary in order to make a
specific diagnosis, and this includes a patient who has
had prior episodes of bleeding. P. Ex. 53 at 5. The
patient here did have recurrent bleeding in that she had
bled back in 1987, and, if the source of the present
bleed wasn't discovered, she was at risk of bleeding
again. Moreover, another exception to the general
conclusion made in this study is that an early endoscopy
should be used if there is a suspicion of malignancy. P.
Ex. 53 at 4. Thus, even though the bleeding in this case
had essentially stopped by September 1, the fact that the
patient here had prior episodes of bleeding and was at
risk of having a malignancy (due to her family history)
makes this an exception to Petitioner's cited rule.
51

his decision to forego doing an endoscopy on this
patient.“ To the contrary, he testified that he based
his decision on his dislike of defensive medicine and
this patient's dislike of undergoing uncomfortable
procedures. Interestingly, the colonoscopy that
Petitioner ordered for this patient is considered to be a
more strenuous test than an endoscopy. Tr. at 298. A
colonoscopy takes longer and requires more sedation than
does an endoscopy. Id. Moreover, it appears that
Petitioner's belated reference to this controversy is an
attempt to use post hoc rationalizations as an
explanation for his actions. Thus, I find that, absent
any evidence that the controversy regarding the use of
endoscopies had been resolved in Petitioner's favor in
1991, and absent any evidence that Petitioner was even
aware of the controversy and relied on it to support his
treatment of this patient, the expert testimony regarding
the standard of care in 1991 should be applied in this
case.

Petitioner belatedly argued also that an endoscopy was
not done during the hospitalization, due to the
unavailability of an endoscopist, and that further GI
evaluation would have been performed subsequent to her
discharge if she had not adequately recovered as an
outpatient. Tr. at 353; I.G. Ex. 17 at 4. He made this
argument in April 1992, in response to IPRO's challenge
of the treatment of this patient. I.G. Ex. 17 at 4.
Again, such reasoning is suspect, since Petitioner's

i Petitioner acknowledged that an endoscopic
examination would have been the most accurate means to
diagnose the reason for the upper gastrointestinal bleed.
Tr. at 353.

8 The I.G. attempted to introduce an article
which contradicts the one relied on by Petitioner. The
I.G. asserts that this article, which is written by one
of the same authors of the article cited by Petitioner,
indicates that the standards of care for upper GI bleeds
requires early endoscopies. I.G.'s Brief at 23 - 24. I
do not accept this article into evidence because it was
submitted untimely. The I.G. had the opportunity to
request an extension of time to submit the article after
the hearing in this case and failed to do so. Moreover,
in light of my conclusion that the existence of a
controversy in 1991 does not alter the professional
standard of care to examine the patient's upper GI tract
in instances of bleeding from that area, the new article
offered by the I.G. is not relevant.
52

hospital progress notes for the patient (which were
completed shortly after her discharge in 1991) contain no
references to consideration of an endoscopy examination.
I.G. Ex. 17 at 9 ~ 12. In response to my questions,
Petitioner indicated that the progress notes contain the
summarization of his treatment of the patient.” Tr. at
357. He further indicated that "all of the information
that [he] thought ... was important to the patient that
(he) discussed with her" would be included in his
summary. Tr. at 358. When I inquired at the hearing why
he did not include in his summary the circumstances
regarding the endoscopic examination that were contained
in his response to IPRO, he replied that this was a
“simple omission." Tr. at 361. I do not find this to be
a credible response. I conclude that Petitioner did not
consider conducting an endoscopic examination of this
patient either as part of her hospitalization or part of
her aftercare.

Petitioner's failure to perform either an endoscopy or
upper GI series examination was a substantial violation
ef professionally recognized standards of care.
Petitioner's violation of professionally recognized
standards of care is serious. Petitioner never
definitively determined the source of the bleeding.
Without doing appropriate diagnostic testing, he
concluded that the bleeding resulted from an hiatus
hernia. Dr. Kops testified that Petitioner's failure to
do an upper GI examination of this patient exposed her to
the serious risk of having a gastric malignancy go
undetected, thus delaying necessary treatment.
Petitioner's failure exposed this patient to the
additional risk of rebleeding. Tr. at 292. Petitioner
acknowledges that the endoscopic examination is the most
accurate tool in diagnosing upper GI bleeds and that, if
the patient rebled, such test would have been ordered.
There is no credible evidence in the record to support
Petitioner's assertion that an endoscopic examination
could not be performed on this patient during her
hospitalization. Nor do professionally recognized
standards of care support Petitioner's apparent medical
judgment to await a future GI bleed before conducting an
upper GI examination of this patient.

16 Petitioner testified that the progress notes
reflect "the chief complaint, the physical findings that
are pertinent, the laboratory work that's relevant and
the final diagnosis and what happened to the patient."
Tr. at 357.
53

Patient 039837

PRO Findings: Failure to obtain a post-procedure x-
ray resulting in delay of diagnosis, and failure to
properly evaluate and work-up a septic patient.

{[I.G.)} An alysis: Patient had a 40% collapse of a
lung due to air between the lung and the chest wall.

This followed an attempt to remove fluid from the
chest, and required insertion of a chest tube to
attempt to re-expand the lung by removing the aid
compressing the lung. A chest x-ray should have
been obtained to determine the status of the chest
after the first procedure. Also, urine cultures
were not obtained on this septic patient.

[I.G.} Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

: On September 28, 1991, this patient, an 89-
year-old female, was transferred from the chronic care
ward to the active floor of Little Falls Hospital. At
the time of the transfer, her skin was mottled, as if she
was about to die, and she was bathed in cold
perspiration. She was unresponsive. She had a
temperature of 104 degrees, a cough and diarrhea. I.G.
Ex. 18 at 4, 11, 14, 16; Tr. at 211 - 212. Petitioner
diagnosed her as being in a septic state. I.G. Ex. 18 at
14. Petitioner did not take a urine culture. However,
he did take blood and sputum cultures. I.G. Ex. 18 at 5.

An x-ray revealed a large pleural effusion, a large
amount of fluid in her right chest. I.G. Ex. 18 at 4,
48; Tr. at 213. This problem had appeared previously and
it had been treated; however, it recurred rapidly. Tr.
at 213. Petitioner performed a thoracentesis on the
patient that day.” I.G. Ex. 18 at 12. The

thoracentesis was accomplished with difficulty, since the
patient could not sit up due to the fact that she had no
palpable blood pressure. In order to perform the
procedure, it was necessary for her to be placed with her
right side down and her head slightly elevated. I.G. Ex.
18 at 4. A follow-up chest x-ray was not taken until the
day following the thoracentesis. Tr. at 103, 215. on
the second hospital day, September 29, a chest x-ray was
performed which revealed a partial pneumothorax on the

" A thoracentesis is a procedure involving the
insertion of a needle into the chest cavity to drain out
fluid. Tr. at 95.
54

right side of the chest.'* The patient had a partial
collapse of her right lung. The upper lobe of the right
lung adhered to the chest wall. I.G. Ex. 18 at 12, 49;
Tr. at 95, 215. The partial collapse of the upper right
lung meant that she had only the use of the lower right
lung and the left lung to breathe. Tr. at 215.

On the third hospital day, September 30, Petitioner
reported that her condition appeared to have improved.
I.G. Ex. 18 at 12. Petitioner did not perform a chest x-
ray. On the fourth hospital day, October 1, the nurses
at the hospital summoned Petitioner and told him that the
patient did not look well. Petitioner reported that she
had some shallow respirations and that she appeared
somewhat stuporous. Tr. at 217; I.G. Ex. 18 at 12. An
x-ray was performed which revealed that her right chest
had again filled up with fluid. I.G. Ex. 18 at 50; Tr.
at 217. Another thoracentesis was performed. A chest
tube was inserted which drained fluid for a few days.
I.G. Ex. 18 at 12; Tr. at 217 - 218. As a result of the
chest tube, her right lung re-expanded and the pleural
effusion decreased. I.G. Ex. 18 at 4, 51. On October 4,
1991, the patient died. I.G. Ex. 18 at 13.

The I.G. contends that Petitioner violated his duty to
provide care that meets professionally recognized
standards of health care by failing to take an x-ray of
the patient immediately after performing the September
28, 1991 thoracentesis and by failing to take a urine
culture from the patient. Notice at 3. Petitioner did
not deny that professionally recognized standards of care
required him to perform a chest x-ray immediately after
the September 28, 1991 thoracentesis. Tr. at 215. He
also acknowledged that it was not done until the
following day. Id. Moreover, Petitioner did not deny
that professionally recognized standards of care required
that he obtain a urine culture for the patient, who was
in a septic state upon arrival at the active floor of
this hospital. Petitioner admitted that his failure to
take a urine culture was an oversight. I.G. Ex. 18 at 5.

With regard to the failure to take an x-ray immediately
after performing the thoracentesis, Petitioner's
arguments focused primarily on his decision to delay the
insertion of the chest tube. He asserted that he elected
to wait to insert the chest tube until two days after he

a Dr. Sperling testified that a pneumothorax
exists when air has accumulated in the chest cavity.
Petitioner did not contest this definition, therefore, I
accept it as true. Tr. at 95.
55

discovered the pneumothorax because he thought that if it
was left alone it would reabsorb and the lung would re-
expand. Tr. at 216. He testified also that another
reason he waited until the fourth hospital day was that
her oxygen saturation was good on the third hospital day
and a physical examination indicated that she had air in
her chest, Tr. at 217.

Dr. Sperling's testimony focused primarily also on
Petitioner's insertion of the chest tube. He indicated
that the chest tube should have been inserted on the
first hospital day, immediately after discovering the
first pleural effusion. Tr. at 97. He indicated that
Petitioner's delay in inserting the chest tube
compromised the patient's care and put her at risk for
developing a tension pneumothorax, and an inability to
breathe, which would lead to a mediastinum flutter and
cardiac arrest.” Tr. at 98 - 99. He testified that
these risks were "directly due to a thoracentesis that
was done inadequately, and should not have been done,
other than for a smear, and then should have been
followed up immediately by a chest x-ray." Tr. at 98.
As to the timing of the x-ray, he testified that it is
necessary to take a chest x-ray immediately after doing
the thoracentesis, at the patient's bedside, in order to
make sure ‘that no damage was done during the
thoracentesis and to determine whether all the fluid had
been removed. Tr. at 96.

Petitioner's expert witness, Dr. Nicholas, stated that
Petitioner inserted the chest tube at the appropriate
time, since the need for the chest tube was the re-
accumulation of fluid in her chest, and not the
pneumothorax, and that this pleural effusion did not
appear until the fourth hospital day. Tr. at 455. Dr.
Nicholas testified also that there would be controversy
among "reasonable doctors" as to the timing of the chest
tube insertion in this patient. Tr. at 456. He
indicated that this was a peculiar case, since the
patient's right lung had only partially collapsed and she
was still able to breathe and she was doing well
clinically. Id.

As for the chest x-ray, however, Dr. Nicholas admitted
that the standard of care is for a chest x-ray to be
taken on the same day that thoracentesis is performed,
and he indicated that Petitioner violated the standard by

9 In his testimony, Dr. Sperling defined a
pneumothorax. He explained that the term means that
there is air in the chest cavity. Tr. at 95.
56

failing to do so. Tr. at 466 - 467. Yet, he testified
that the delay in obtaining a chest x-ray did not
compromise the patient's care in this case. Tr. at 452.
In support of his position, he cited to IPRO's second
physician's review, which states that "It [the x-ray]
should have been done no matter what the clinical
improvement was but it would not have prevented the
pneumothorax or changed the course." Dr. Nicholas noted
also that the second IPRO physician who reviewed
Petitioner's medical records and the findings of the
first reviewing physician, reduced the quality
determination from a level three violation to a level two
violation.”

I find that Petitioner's conduct was a substantial
violation of professionally recognized standards of care.
By delaying the x-ray, Petitioner delayed the diagnosis
of this patient. At the 1992 hearing before IPRO, Dr.
Sperling asked Petitioner if he considered "getting a
portable x-ray up and putting the chest plate under her"
in order to determine whether the thoracentesis procedure
caused the pneumothorax. I.G. Ex. 6 at 46. Dr. Sperling
indicated that an x-ray immediately after the
thoracentesis was necessary because Petitioner performed
the thoracentesis with the patient on her side, and
therefore, he "violated a closed space with a needle."
Id. If an x-ray had been taken right after the
thoracentesis, Petitioner could have immediately
determined whether his needle had caused the pneumothorax
which was discovered a day after the thoracentesis was
performed. In addition, during the 1992 hearing before
IPRO, Petitioner essentially admitted that the
pneumothorax had probably resulted from the difficulty he
encountered in doing the thoracentesis. I.G. Ex. 6 at
55.

Furthermore, at the hearing before me, Dr. Sperling
testified that a portable x-ray should have been taken
after the thoracentesis:

20 Dr. Sperling explained the significance of the
Level I, II and III determinations made by the PRO:

Level 1 is incurring a disability to the patient
that is not life-threatening. Level 2 is developing
a severe disability to the patient that is life-
threatening. Level 3 is a life-threatening
situation which did or did not cause a mortality.

Tr. at 100.
57

to make certain that you've gotten the fluid out,
that you haven't clipped the lungs and now
developing a pneumothorax, a tension pneumothorax,
which would directly affect the patient's cardiac
status, you just have to do it just to make certain
that you haven't caused any damage. After all
you're going in blindly. You don't know where
you're putting that needle or trochar, so you have
to see what you've done.

Tr. at 96. Thus, the significance of taking an x-ray
immediately after the thoracentesis is to ensure that the
thoracentesis was done properly, that all of the fluid
was removed from the patient's chest, and that no damage
was done to the lung.

Petitioner's failure to follow the standard procedure
upon completion of a thoracentesis delayed diagnosis, in
that a pneumothorax and a partial collapse of the right
lung was discovered the day after the thoracentesis, and
a second pleural effusion appeared two days after the
pneumothorax was discovered. Tr. at 215 - 218.
Petitioner indicated, at both the 1992 and 1993 hearings
before IPRO, that as a result of this case he now
routinely takes x-rays immediately after doing a
thoracentesis. I.G. Ex. 6 at 55; I.G. Ex. 3 at 308.

I find also, as Dr. Sperling asserts, that Petitioner's
violation contributed to the risk of the patient
developing a tension pneumothorax and an inability to
breathe which could lead to cardiac arrest. Petitioner's
failure to x-ray the patient until the day after the
thoracentesis delayed discovery of the pneumothorax.
According to professionally recognized standards of care,
his failure to monitor his patient's condition put her at
risk of developing further complications. Indeed, the
patient developed a pleural effusion two days after the
pneumothorax was discovered.

Dr. Sperling's opinion with regard to the risks he cited
was based not only on Petitioner's failure to immediately
obtain a chest x-ray, but also upon his opinion that
Petitioner inadequately performed the thoracentesis and
waited too long to insert the chest tube. Tr. at 97. I
do not consider the significance of these additional
allegations, since they are not relevant to the issue of
whether he violated professionally recognized standards
of care in this case. IPRO cited Petitioner for his
failure to obtain a post-thoracentesis x-ray, and not for
the adequacy of his thoracentesis or his alleged delay in
inserting the chest tube. Accordingly, I do not consider
these other allegations of wrongdoing, and my
58

determination that Petitioner substantially violated
professionally recognized standards is based only on his
failure to obtain a post-thoracentesis x-ray. I do find,
however, that Petitioner's failure to obtain an immediate
post-thoracentesis x-ray contributed to the risk of this
patient developing an inability to breathe as a result of
the pneumothorax, and possibly led to cardiac arrest, as
stated by Dr. Sperling. These are serious risks which
possibly could have been avoided had Petitioner followed
professionally recognized standards of care in this case.
The reduction by the IPRO physician of the level of care
violation from three to two does not negate the
conclusion that Petitioner's conduct placed this patient
at serious risk, albeit it may not have caused her death.

IPRO found also that Petitioner failed to properly
evaluate and work-up a septic patient. Notice at 3.
Upon initial examination of the patient, Petitioner
diagnosed her as being in a septic state. I.G. Ex. 18 at
14. He performed blood and sputum cultures, but failed
to do a urine culture. I.G. Ex. 18 at 5. When
questioned about his failure to perform a urine culture,
Petitioner admitted that he simply forgot to do it. Id.
Moreover, Petitioner did not rebut the I.G.'s finding
that Petitioner's failure to take a urine culture was in
violation of professionally recognized standards of care
for a patient who is in a septic state.

Dr. Nicholas testified that, since it was determined from
the serum culture that the patient in this case had
influenza, and since the patient did not have any urinary
symptoms, it was not unreasonable for Petitioner to have
foregone a urine culture. Tr. at 458 - 459. He stated
also that it is possible that the patient was not truly
septic, within the proper meaning of the word. Tr. at
459. Finally, he asserted that, at the time the patient
was first examined, she was "essentially suffocating,"
and the urine culture was not the first priority. Tr. at
460. These arguments are unpersuasive, however, since
Petitioner indicated that he did not make a conscious
decision to forego a urine culture for this patient,
rather he simply forgot to do it. I.G. Ex. 6 at 43, I.G.
Ex. 3 at 86, I.G. Ex. 18 at 5. Moreover, Dr. Nicholas
did not deny that the professionally recognized standard
of care for a patient who the examining doctor believes
is in a septic state is to obtain a urine culture. Tr.
at 462. On the basis of all of the testimony and medical
records in this case, I find that Petitioner's failure to
obtain a urine culture of this patient was a substantial
violation of professionally recognized standards of care
for a septic patient.
59
Patient 058705

PRO Findings: Failure to initiate treatment of
local skin lesions resulting in a decubitus ulcer.

[I.G.} Analysis: Patient noted to have blisters on
buttocks and be debilitated. No plan of care or
treatment was initiated and patient developed a 4
em. decubitus ulcer. Practitioner states that local
treatment with ointment, daily, as well as systemic
antibiotics were given for therapy of ulcer which
became a decubitus. The medical record shows an
order for ‘neosporin ointment to decubiti Lt.
Buttock BID' by telephone order 7/31/91, for patient
admitted 7/8/91 and discharged 8/2/91. Nurses note
abrasion left buttock on admission. Yellow central
area with surrounding 6" red area on buttock noted
7/14/91, treated with A & D ointment.

[I.G.] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

My Analysis: This patient was a 73-year-old man who was
admitted to Little Falls Hospital on July 8, 1991, after
being found lying on the floor of his apartment. I.G.
Ex. 19 at 12 - 13. In his progress notes, written on the
date the patient was admitted, Petitioner noted that the
patient had blisters on his buttocks. Petitioner
attributed this to the fact that the patient had been on
the floor of his apartment for a considerable period of
time. I.G. Ex. 19 at 14, 25.

On examination, the patient had a considerable amount of
dried feces around the rectum. His family reported that
he had a continuing problem with bowel incontinence.

I.G. Ex. 19 at 16. In his admission report, Petitioner
opined that the patient's incontinence was probably
explained by chronic impaction, and he indicated that he
would attempt to relieve the impaction. I.G. Ex. 19 at
17. Petitioner stated also that the patient probably had
chronic organic brain syndrome. Jd.

On July 11, 1991, Petitioner's progress notes indicated
that the patient's cellulitis on his buttock was
"involuting." I.G. Ex. 19 at 26. His progress note
entered on July 16, 1991 indicated that the patient's
ulcer on his left buttock was "{hJealing." Id. That
note indicated also that the lesion was six centimeters
in size. On July 29, 1991, Petitioner's progress notes
state that the patient had an unhealed ulcer on his
60

buttock that was four centimeters in size. I.G. Ex. 19
at 27.

On July 31, 1991, Petitioner telephoned an order that the
lesion be treated with Neosporin, a topical antibiotic.
I.G. Ex. 19 at 24; Tr. at 261. On August 2, 1991, the
patient was discharged to the County Home for ongoing
care. I.G. Ex. 19 at 13, 15. Petitioner's final
diagnoses included cellulitis of the buttock and
decubitus ulcer. I.G. Ex. 19 at 10. The patient's
discharge instructions included application of Neosporin
ointment to the buttock. I.G. Ex. 19 at 107.

The nursing notes contained in the chart describe the
patient's buttocks on the date of admission as reddened
with skin breakdown. The nursing notes indicated also
that the patient was being moved from side to side at
regular intervals. I.G. Ex. 19 at 54. On July 9, 1991,
the nurses applied A&D ointment to the left buttock.
I.G. Ex. 19 at 56. The nursing notes reported that on
July 10, 1991, the patient ambulated from the bed to the
chair with some assistance. I.G. Ex. 19 at 58.

On July 11, 1991, the nursing notes described the
patient's lesion on his left buttock as a "yellow central
area surround[ed] by 6" diameter red area" and indicated
that there was "no drainage."”! The nurses applied A&D
ointment, and reported that the patient ambulated well
with a walker. I.G. Ex. 19 at 60. The following day the
nursing notes reported that "Red area on L[eft] buttock
seems smaller (approx 5 [inches}) diam) & less red than
7/11." On that day, the patient ambulated in the hall
with a walker. I.G. Ex. 19 at 62.

On July 15, 1991, the nursing notes indicated that the
left buttock abrasion was "much smaller" than it had been
on July 12, 1991. The notes stated that it was a "small
open area near large white patch surrounded by small red
margin." In addition, the notes stated that A&D ointment
was applied and that the patient was moved out of bed to
his chair. I.G. Ex. 19 at 68. On July 16, 1991, the
nursing note described the abrasion as yellow with dry
skin at the margins. A&D ointment was applied. The
patient was reported as tolerating activity well. I.G.
Ex. 19 at 70.

21 The I.G. Analysis in the Notice incorrectly
states that the nursing notes give this description of
the lesion on July 14, 1991 rather than on July 11, 1991.
61

On July 21, 1991, the nursing notes stated that the
patient's wound on his left buttock was "healing" and
that it was clean with clear edges. I.G. Ex. 19 at 80.
The following day the nursing notes described the
abrasion as an “open area" with a "small amount of yellow
drainage." A&D ointment was applied. I.G. Ex. 19 at 62.
The next day the nurse noted a "small amount of red
drainage." A&D ointment was applied. I.G. Ex. 19 at 84.
The nurse stated that there was "no change" to the
patient's buttock condition the following day. I.G. Ex.
19 at 86.

On July 30, 1991, the nurse noted an open area on the
left buttock and stated that it "appears to be healing."
I.G. Ex. 19 at 98. The following day the nurse reported
that the lesion was a "dry, open area" and that the
patient did not complain of pain. I.G. Ex. 19 at 103.

The undisputed expert medical evidence shows that
prolonged pressure can result in a breakdown of the skin
ind a diminished blood supply to the affected area. As
the tissue breaks down, it can develop into an infection
that erodes the layers of skin and affects the muscle and
bone. In addition, it is undisputed that professionally
recognized standards of care require an attending
physician to initiate a written plan of care to address
skin conditions caused by prolonged pressure. Tr. at
255, 272.

Petitioner admitted during the hearing that he did not
adequately document a plan of care. Tr. at 486, 489 -
490. This admission is supported by the patient's chart,
which shows that the only written documentation of a
physician order pertaining to the treatment of this skin
condition was made on July 31, 1991, when Petitioner
telephoned an order for Neosporin. I.G. Ex. 19 at 24.

In view of the foregoing, I find that Petitioner failed
to document a plan of care to treat this patient's skin
condition and that this was a substantial violation of
his obligation to provide care in accordance with
professionally recognized standards of care.

The I.G. argues that this case is not simply a matter of
poor documentation. The I.G. contends that Petitioner
failed to properly address and follow up on the patient's
need for skin care and that this is demonstrated "by the
fact that his condition worsened over the course of his
hospitalization, and that there were no physician's
orders expressly addressing this condition until July 31,
1991, some 23 days after admission." I.G.'s Reply at 6.
62

Petitioner alleges that he initiated a plan of care to
address this patient's skin condition and that he
directed the nurses to carry it out orally. He contends
that his care did not cause the patient's condition to
worsen. He asserts also that the patient did not ever
have a true decubitus ulcer, as the I.G. alleges.

I find that the evidence establishes that this patient
suffered from a decubitus ulcer. This patient's medical
chart shows that the final diagnoses of this patient's
medical condition made by Petitioner included a decubitus
ulcer. Petitioner's diagnosis of a decubitus ulcer is
supported by Dr. Kops' testimony. Dr. Kops defined a
decubitus ulcer as an erosion or ulceration of tissue
caused by prolonged pressure. He indicated that
decubitus ulcers can vary in their severity. As the
decubitus ulcer becomes more severe, it can erode muscle
and bone tissue. Tr. at 255.

The July 11, 1991 nursing notes described this patient's
skin lesion as a yellow central area surrounded by a red
area six inches in diameter. Dr. Kops testified that
this description of the condition of this patient's skin
is consistent with the formation of a decubitus ulcer.
Tr. at 257. In addition, Dr. Kops opined that this
patient had a decubitus ulcer on July 22, 1991, when the
nursing notes described the affected area as open with
small amounts of yellow drainage. Dr. Kops testified
that this description suggested the drainage of pus. On
July 23, 1991, the nursing notes described red drainage,
and Dr. Kops testified that this suggested that the
drainage was mixed with blood. Tr. at 259 - 260.

I find this evidence to be persuasive, and it establishes
that this patient had a decubitus ulcer during the course
of his hospital stay. The Merck Manual] provides
additional support for this finding. It defines a
decubitus ulcer as ulceration of tissues that have been
subjected to prolonged pressure. It states that the
stages of decubitus ulcer formation correspond to tissue
layers. The first stage consists of skin redness that
disappears on pressure. The second stage shows redness,
edema, and induration, at times with blistering. In the
third stage, the skin becomes necrotic, with exposure of
fat. In the fourth stage, necrosis extends to the
muscle. Further fat and muscle necrosis characterizes
the fifth stage. In the sixth stage, bone destruction
begins. Merck Manual (15th ed. 1987) at 2298.

Dr. Nicholas testified that this patient never developed
a "true" decubitus ulcer. He defines a decubitus ulcer
as an ulcer which has penetrated through all the layers
63

of the skin "into underlying structures and then even
deeper down into facia, muscle and bone." Tr. at 568.
He states that, using that definition, this patient did
not have a decubitus ulcer. Tr. at 569. Dr. Burke's
testimony echoed that of Dr. Nicholas. He stated that,
while this patient developed a superficial infection in
the affected area, the lesion was not a decubitus ulcer
because it did not affect the tissue underlying all the
layers of the skin. Tr. at 488.

Neither Dr. Nicholas or Dr. Burke dispute that this
patient had an ulceration of superficial tissue which was
caused by prolonged pressure. They disagree with the
I.G. only on nomenclature. While it may be true that the
patient did not have a decubitus ulcer according to their
definition of that term, I do not accept their
definition. The definition advocated by Dr. Nicholas and
Dr. Burke is not consistent with the definition contained
in the Merck Manual. That medical treatise indicates
that an ulcer which affects only superficial tissue is a
decubitus ulcer in its early stages of formation.

Moreover, the definition of a decubitus ulcer offered by
Petitioner and Dr. Nicholas at the hearing is not
consistent with Petitioner's contemporaneous diagnosis of
a decubitus ulcer. Petitioner has consistently
maintained that only superficial layers of tissue were
affected by the ulcer, and there is nothing in the
descriptions of this patient's buttock in the chart which
indicate that deep layers of tissue were affected.
Petitioner diagnosed a decubitus ulcer for a condition
that he maintains affected only superficial tissue. His
attempt to now redefine the term decubitus ulcer ina
self-serving manner is not persuasive.

In addition, I find that Petitioner did not prove that he
initiated a plan of care to treat this patient's skin
condition which Petitioner communicated to the nurses
orally.

Petitioner testified that he became aware that this
patient had a blister on the buttock when the patient was
admitted and that he discussed the treatment of the
patient's skin lesion with the nurses at that time. He
stated that he emphasized to the nurses that the patient
should be kept as dry as possible. In addition, he
stated that, since the patient was relatively inactive
due to a fever, he instructed the nurses to turn the
patient from side to side and to protect the affected
area from continuous pressure. Petitioner stated also
that he instructed the nurses to keep the affected area
64

lubricated and to try to maintain the patient's
nutrition. Tr. at 480 - 481, 485 - 486.

Petitioner's testimony that he was aware that this
patient had a blister on his buttock at the time the
patient was admitted is corroborated by his July 8, 1991
progress note. However, there is no corroboration for
his testimony that he instructed the nurses to take
specific measures to care for this condition at the time
the patient was admitted.

Petitioner's progress notes and his orders do not mention
these instructions. While the nursing notes show that
the care the nurses gave to this patient was consistent
with the instructions Petitioner testified he gave to the
nurses, there is no indication in the nursing notes that
this care was given pursuant to instructions from
Petitioner. Indeed, Petitioner testified that the
"problem of pressure sores and the problems of infection
are a day by day problem for the people who are nurses."
Tr. at 486. This comment suggests that Petitioner relied
on the nurses to provide routine treatment for this type
of condition.

Moreover, a nurse did document Petitioner's July 31, 1991
telephone order for Neosporin. I.G. Ex. 19 at 24. This
suggests that, had Petitioner ordered the nurses to
follow a designated treatment plan, they would have
documented that plan in the patient record. Also absent
from the record is the testimony of the nurse who would
have received the oral instructions Petitioner asserts he
gave. In view of the foregoing, I am not convinced by
Petitioner's unsubstantiated testimony that he initiated
a plan of care to treat this patient's skin condition
which he communicated to the nurses orally at the time
the patient was admitted. I find also that Petitioner's
failure to orally initiate a plan of care to treat this
patient's skin condition is a substantial violation of
professionally recognized standards of care.

While I find that Petitioner's failure to initiate a plan
of care is a substantial violation of professionally
recognized standards of care, this does not mean that I
conclude that Petitioner ignored this patient's skin
condition. The record shows that treatment was provided
by the nurses from the beginning. The patient was turned
from side to side at regular intervals. The patient was
ambulating within days of his admission, and he was
encouraged to ambulate regularly after that. The nurses
applied A&D ointment repeatedly. The patient's linens
were changed when they were wet, and the nurses monitored
his eating. I.G. Ex. 19 at 54 - 103.
65

This treatment was provided by the nurses in coordination
with Petitioner's visits to attend to the patient. It is
reasonable to conclude that, while Petitioner did not
explicitly order the nurses to provide this treatment, he
was aware of it and he did nothing to show that he
disapproved of it. In addition, Petitioner made periodic
notations in his progress notes regarding this patient's
skin condition, which shows that he was monitoring it.

He was, therefore, in the position to intervene and alter
the treatment if he thought it was necessary. In fact,
he did intervene on July 31, 1991 when he ordered
Neosporin for this patient. Petitioner testified that
the reason he ordered Neosporin at this time was that he
wanted the patient to have it to treat his unhealed ulcer
after he left the hospital. Tr. at 488. Thus, I find
that, although Petitioner did not explicitly initiate a
plan of care, he nevertheless was informed about the
patient's condition and he was involved in the treatment
of it.

Moreover, I find that the evidence fails to establish
that Petitioner's care of this patient's skin condition
resulted in adverse consequences to this patient, as the
I.G. alleges.

The I.G.'s assertion that this patient's condition
worsened over the course of the hospitalization implies
that the patient's skin condition steadily deteriorated
during the course of his hospital stay. While the
descriptions of the patient's decubitus ulcer in the
chart demonstrate that Petitioner's skin ulcer never
healed completely during the course of the
hospitalization, they do not show that his condition
consistently worsened over time.

On the contrary, the chart entries show that the
condition had periods of healing during his hospital
stay. The patient was admitted on July 8, 1991 with a
blister on his buttocks. This finding on admission
suggests that, under the Merck Manual description of the
staging of decubitus ulcers, the patient had a decubitus
ulcer in its early stages. Three days later, Petitioner
noted that it had gotten smaller.” Nursing notes on
July 12 and 15, 1991 reported that the lesion was getting
smaller. Petitioner's July 16, 1991 note described the
lesion as "healing." The nursing note entry on July 21,

2 petitioner's July 11, 1991 progress note
describes the condition as "involuting." The American
Heritage Dictionary, 2d College Edition, defines
“involute" as "{h]aving the margins rolled inward."
66

1991 also described the lesion as "healing." While some
drainage was noted for the first time by the nurses on
July 22 and 23, 1991, the notes described it as a "small
amount" and there is no indication that the lesion
affected deep layers of tissue such as bone or muscle.
It is at this point in the record of the patient's
hospitalization that his decubitus ulcer is arguably at
its worst stage. But, again using the Merck Manual as a
reference, the evidence fails to establish that the
decubitus ulcer affected deep tissue layers and advanced
beyond the third stage. The I.G. concedes that the
medical records' description of the patient's decubitus
ulcer is "consistent with the lesion progressing through
the early stages of a decubitus." I.G.'s Supplemental
Brief at 3. On July 30, 1991, the nursing notes indicate
that the lesion "appears to be healing." On July 31,
1991, the nurses describe the lesion as dry and the
patient did not complain of pain.

Dr. Kops provided testimony which suggests that
Petitioner failed to treat this condition adequately.

The nursing notes state that there was a breakdown of
skin on the date of admission. Dr. Kops opined that,
once the skin breaks down, the application of A&D
ointment is inappropriate because it traps moisture and
may cause further breakdown of the skin. Tr. at 258.

Dr. Kops stated also that a topical antibiotic should be
applied as soon as the skin breaks down. In addition, he
stated that dressings should be changed daily. Tr. at
262. While Dr. Kops criticized the care this patient
received, he then contradicted himself and testified that
the nursing care, including the application of ointment,
was in accordance with professionally recognized
standards. He testified that the deficiency here was
just a lack of documentation and a lack of specific order
to the nurses. Tr. at 274. Dr. Kops' testimony is
confusing and contradictory, and, therefore, I find that
it does not establish that Petitioner's care was
inadequate.

On the other hand, Dr. Nicholas testified that the
measures which were taken to treat this skin condition
were in accordance with professionally recognized
standards of care. Tr. at 581. He indicated that
relieving the pressure on the lesion is imperative and
that this was done when the nurses moved the patient from
side to side and encouraged the patient to get out of
bed. In addition, he stated that it is important to
attend to the patient's nutrition and that this was done
here. Tr. at 566 ~- 567, 586 - 587. He acknowledged
that, while the application of A&D ointment may have some
drawbacks, it has the substantial benefit of decreasing
67

the likelihood that the condition will be aggravated by
sheet burns. He explained that a week of healing can be
destroyed with "one yank across the sheet." Tr. at 573.
Dr. Nicholas opined also that the use of dressings is
"optional." He indicated that the use of dressings for
superficial lesions has the disadvantage of making the
skin "sort of water logged and fragile." Tr. at 573 -
574. He indicated also that antibiotics generally are
not necessary to treat superficial lesions. Tr. at 575.

The record fails to demonstrate that any of the
treatments employed had a significant adverse effect
resulting in the worsening of the patient's ulcer during
his hospitalization. As previously conceded by the I.G.,
this patient's ulcer never progressed beyond the early
stages.”

Also Dr. Nicholas expressed the view that the reason this
patient's condition persisted was not due to the care he
received, but instead it was due to the fact that he was
impacted and incontinent. The unfortunate consequence of
this condition was that the patient sometimes was lying
in liquid diarrhea. Tr. at 580. Even Dr. Kops
acknowledged that the fact that this patient was
continually soiling himself would impede the quick
healing of this patient's skin condition. Tr. at 263.

Dr. Nicholas' opinion on the adequacy of Petitioner's
treatment of this patient is well-rationalized and
persuasive. I find that the evidence does not establish
that this patient suffered any adverse consequences as a
result of Petitioner's care of his skin condition.

Patient 032141

This patient involves two cases referred to in the I.G.
Notice (Cases 6 and 7 at page 4 of the Notice). The
first case pertains to Petitioner's treatment of the

3 As indicated in the Merck Manual at 2299,
"C[ujlcers that have not advanced beyond the 3rd stage may
heal spontaneously if the pressure is removed and the
area is small." The record supports that this patient
was turned from side to side at regular intervals and was
encouraged to ambulate as soon as he was capable of doing
so. This reference from the Merck Manual suggests that
early staged decubitus ulcers are not particularly
significant, as long as they are not allowed to worsen to
a later stage (stages four to six) where there is muscle
necrosis and bone destruction, neither of which occurred
in this case.
68

patient after she was admitted to Little Falls Hospital
on July 25, 1991. The second case pertains to
Petitioner's treatment of the patient after she was
admitted to Little Falls Hospital on August 4, 1991.

irs se: (Admission date 7/25/91)

PRO Findings: Failure to evaluate severe pain ina
patient resulting in premature discharge and
readmission for the same complaint within 72 hours.

[I.G.}] Analysis: Patient discharged without
evaluation of complaint (severe left thigh pain).
Patient was discharged but readmitted for the same
complaint within 72 hours. Patient complaining of
pain on day of discharge.

[I.G.] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

Second case: (Admission date 8/4/91)

PRO Findings: Failure to evaluate severe pain in a
patient resulting in premature discharge and
readmission for the complaint with 48 hours.

[I.G.] Analysis: Patient hospitalized and
discharged without evaluation of complaint (severe
left thigh pain). This resulted in premature
discharge and subsequent readmission within 48
hours. There is not an extended period of pain
relief.

[I.G.}] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

My Analysis of both cases: The medical record pertaining
to these two cases shows that the patient, a 70-year-old
female, was initially admitted to Little Falls Hospital
on July 25, 1991. In a medical report written at the
time of the patient's admission, Petitioner described the
patient's chief complaint as "“Intractable pain, left
lateral thigh, two weeks duration." Petitioner noted
that "(t)his patient is no stranger to intractable pain"
and that she had a history of recurrent pains in the
abdomen and chest of an unknown etiology. Petitioner
noted also that in the past the patient “has been
suspected of dependency on Darvon." I.G. Ex. 20 at 14 -
15.

69

Petitioner reported also that his physical examination of
the patient at the time of admission revealed that the
patient had "point tenderness at the insertion of the
fascia lata into’ the greater trochanter on the left
side." He noted that the patient had been treated as an
outpatient three to four days prior to admission with
injections of medication. This had given her relief from
the pain for about an hour, and then the pain recurred.
Upon admission, Petitioner again injected the patient
with medication at the base of the trochanter on the left
side. Again, this injection gave the patient relief from
the pain for a short period, and then it recurred. I.G.
Ex. 20 at 15. At the time of admission, Petitioner
diagnosed "Pain, left lateral thigh, either trochanteric
tendinitis with fascia lata syndrome or diabetic
neuropathy." I.G. Ex. 20 at 14.

Petitioner referred the patient to a physical therapist
for treatment. In a report dated July 26, 1991, the
physical therapist reported that the patient had
discomfort during hip flexion and external rotation.
During the course of the patient's hospital stay, she was
treated with a combination of ultrasound, moist heat, a
"TENS" unit, anti-inflammatory medication, and a series
of active exercises. I.G. Ex. 20 at 24, 27.

In addition, Petitioner obtained a psychiatric
consultation. In a report dated July 30, 1991, the
consulting physician opined that, while the patient did
not appear to suffer from any major psychiatric illness,
there was a possibility that the patient's pain could be
symptomatic of a major depression. I.G. Ex. 20 at 22 -
23. During this admission, the patient was not examined
by an orthopedist or neurologist, nor were any x-rays or
"CAT" scans taken of the patient's hip and thigh. Tr. at
643.

The patient complained of intermittent pain throughout
her stay in the hospital. Ex. 20 at 42 - 56. On August
1, 1991, the day that she was discharged, she complained
of pain and became more comfortable after a new patch was
applied to the "TENS" unit. At the time of discharge,
she was independent in ambulation and was able to bear
weight on her left leg. I.G. Ex. 20 at 27. In the
discharge summary, Petitioner reported that the patient's
"pain problem had improved, but it had not been
completely relieved." The patient was discharged with
instructions to take medication, and she was advised to
see Petitioner for a follow-up examination. I.G. Ex. 20
at 13, 62. She was discharged with a diagnosis of left
trochanter tendinitis with fascia lata syndrome. I.G.
Ex. 20 at 8.
70

On August 4, 1991, the patient was again admitted to the
hospital for the same complaint of severe pain in her
left thigh. She was injected with local anesthetics in
the tender area of the left trochanteric area. The pain
remained intractable, and she was admitted to the
hospital for care and "perhaps additional diagnostic
Maneuvers." However, at 9:00 p.m., the patient had
achieved complete relief of her pain. I.G. Ex. 20 at 80.
The following morning the patient reported no pain and
was discharged. I.G. Ex. 20 at 95. As with the previous
admission, no x-rays or "CAT" scans were taken, and no
orthopedic or neurologic consultations were obtained.

Tr. at 645 - 646. On August 7, 1991, she was readmitted
to the hospital with the same complaint. I.G. Ex. 6 at
118.

The I.G. did not offer any direct testimony at the
hearing in support of the PRO findings. Instead, the
I.G. contends that the record substantiates the PRO
findings set forth in the Notice.

The I.G. argues that, during these two admissions,
Petitioner did not take the necessary steps to accurately
diagnose this patient's condition, but attempted only to
treat her symptoms. In support of this argument, the
I.G. relies on the fact that, during both admissions, no
radiologic studies were done and no consults from a
neurologist or orthopedist were requested by Petitioner.
The I.G. points out also that, although the patient's
pain was addressed during the first admission with
injections and a "TENS" unit, the entries on the chart do
not reflect any consistent alleviation of her condition.
According to the I.G., Petitioner's failure to adequately
evaluate this patient during the first admission resulted
in a readmission of the patient within 48 hours of her
first discharge. The I.G. argues that, even after the
second admission, Petitioner lacked the information
needed to make a definitive diagnosis and points out that
the patient was readmitted within 48 hours. The I.G.
contends that Petitioner prematurely discharged the
patient on August 1, 1991, after the first admission and
that the second discharge, on August 5, 1991, was
premature as well.

I find that in these cases the weight of the evidence
fails to establish the PRO Findings contained in the
Notice.

I agree with the I.G. that the evidence establishes that
Petitioner did not perform any radiologic studies and
that he did not obtain medical consultations, other than
a psychiatric consultation, during the two hospital
71

admissions at issue. However, I do not agree with the
I.G. that, based on this, I must conclude that Petitioner
failed to evaluate the patient's pain in accordance with
professionally recognized standards of care.

The I.G. has not presented any expert medical opinion
evidence setting forth what tests and consultations would
be necessary to meet professionally recognized standards
of care under the circumstances of this case. The I.G.
did not offer any direct testimony at the hearing on this
issue, nor did the I.G. cite any documents in the record
which address this issue. Absent medical evidence
establishing that Petitioner's failure to perform
radiologic studies and obtain additional consultations
violated professionally recognized standards of care, I
do not have a basis to make this finding.

In addition, the I.G. relies on the fact that the
patient's pain symptoms had not been consistently
alleviated during her hospital stays and on the fact that
the patient was readmitted within days after being
discharged to support the PRO finding that the patient
was prematurely discharged in these cases. However, the
record is devoid of expert medical opinion evidence
establishing that professionally recognized standards of
care require that the patient should have been free of
pain for a specific period of time before she was
discharged from the hospital. Similarly, the record is
devoid of expert medical opinion evidence establishing
that the patient's readmission to the hospital for the
same complaint within a few days establishes that a prior
discharge had been premature.”

On the other hand, Dr. Nicholas offered expert medical
testimony in which he opined that Petitioner's care of
the patient in these cases was in accordance with
professionally recognized standards of care. Tr. at 642,
652. Dr. Nicholas pointed out that the patient had a
history of fixating on pain and a history of dependence
on drugs. He indicated that these were important
considerations in Petitioner's decision to manage the
patient's care conservatively. Tr. at 630 - 631, 638 -
640.

* At the November 10, 1992 IPRO hearing, Dr.
Nicholas mentioned in passing that he had read a
regulation that provided that "readmissions resulted in
automatic Level 3 citations." I.G. Ex. 6 at 140.
However, the I.G. did not mention or rely on any
regulatory criteria to support the PRO finding that
Petitioner prematurely discharged this patient.
72

Dr. Nicholas noted that Petitioner's physical examination
of the patient at the time of the first hospital
admission revealed point tenderness. According to Dr.
Nicholas, this is often due to tendinitis. Dr. Nicholas
testified that, based on this, Petitioner proceeded to
inject the patient with medication. He indicated that
this procedure is both diagnostic and therapeutic
because, if the injection relieves the pain, it makes a
diagnosis of tendinitis very likely. Dr. Nicholas opined
that Petitioner appropriately evaluated the patient's
pain symptoms. He stated that the fact that the clinical
examination revealed point tenderness together with the
fact that the patient experienced relief of pain with the
injection was highly suggestive of a diagnosis of
tendinitis. Tr. at 631 - 632. Dr. Nicholas testified
that, under these circumstances, radiologic tests and
additional medical consultations were not necessary to
evaluate the patient's condition during the two hospital
stays. Tr. at 652.

Dr. Nicholas opined that the patient was not discharged
prematurely after either of the two hospital stays. He
stated that tendinitis is a condition known to produce
intermittent pain, and that it would be reasonable to
expect a person suffering from this condition to
experience intermittent pain even after discharge from a
hospital setting. According to Dr. Nicholas, the patient
showed a therapeutic response to treatment during both
hospitalizations, and she was appropriately sent home to
be followed as an out-patient. Tr. at 636 - 638.

Dr. Nicholas expressed the view that the wisdom of
Petitioner's evaluation and treatment of the patient was
demonstrated by the fact that the patient was
subsequently admitted to two other area hospitals for
over 56 days for the same pain complaint. During those
56 days, the patient had an extensive array of tests and
her final treatment was the conservative treatment
advocated by Petitioner. In addition, at the end of the
56 days, the patient was suffering from the adverse
effects of morphine. Dr. Nicholas stated that, since
Petitioner was privy to the patient's history of fixating
on pain and drug dependence, he had astutely tried to
avoid lengthy hospitalizations and exposure to addictive
drugs. Tr. at 638 - 641.

Dr. Nicholas' testimony regarding Petitioner's care of
this patient is well-rationalized and persuasive. In
addition, the I.G. has not adduced any expert medical
evidence to rebut Dr. Nicholas' opinion. In view of
this, I find that the I.G. did not prove that Petitioner
73

rendered care to this patient which did not meet
professionally recognized standards.

I have reviewed the transcript from the IPRO hearings
involving this patient. While it is difficult to discern
with specificity the deficiency cited by the IPRO
physicians, it is clear that they were concerned that
Petitioner admitted this patient on several occasions to
evaluate her pain, but he did not perform sufficient
diagnostic tests to evaluate the pain. In addition, IPRO
was concerned that this failure led to two premature
discharges and a need for subsequent readmissions. The
I.G. relies almost exclusively on the lack of diagnostic
tests being performed during the hospitalizations in
issue. However, Dr. Nicholas' testimony establishes
that, under the circumstances of this case, Petitioner's
conservative treatment of this patient without performing
extensive diagnostic tests was meritorious. In reaching
this conclusion, Dr. Nicholas took into account the
chronicity of the patient's pain complaints, her
psychiatric history, her possible drug dependency, and
the hospital records showing improvement or complete
diminishment of her pain prior to each discharge. The
I.G. offered no proof that professionally recognized
standards of care would require different treatment under
the circumstances of these several admissions.

Patient 060460

PRO Findings: Failure to properly evaluate and
treat patient with changing neurological status.

[I.G.) Analysis: Patient admitted with questionable
transient ischemic attacks. No diagnostic work-up
obtained, i.e., carotid studies, doppler or
ultrasound.

{[I.G.] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

My Analysis: This patient, a 76-year old male, was
brought by ambulance to the emergency room at Little
Falls Hospital on August 22, 1991, following a sudden
episode of weakness, slurred speech, and confusion. I.G.
Ex. 22 at 11 - 12. He was admitted for observation with
a preliminary diagnosis of a transient ischemic attack
("TIA"). I.G. Ex. 22 at 13. The I.G. contends that
Petitioner violated his duty to provide care that met
professionally recognized standards of health care by
failing to order a Doppler ultrasound study of the
patient's carotid arteries.
74

TIAsS may be caused by the build-up of arteriosclerotic
plaques in the carotid arteries which restrict blood flow
to the brain. Tr. 111, 610. Patients with stenosis, or
narrowing, of the carotid arteries of 25 percent or more
are at increased risk for both stroke and coronary heart
disease. I.G. Ex. 34 at 4. A Doppler ultrasound is a
non-invasive study which can help to measure the degree
of stenosis of the carotid arteries. Tr. at 113. It is
not possible, based on a physical examination alone, to
diagnose the degree of carotid stenosis. Tr. at 499 -
500.

Stenosis of the carotid arteries may be treated
surgically or medically. The professionally recognized
standard for medical treatment is to give anti-coagulant
drugs, such as aspirin. P. Ex. 50 at 2, P. Ex. 51. The
surgical treatment is carotid endarterectomy, in which
the arteriosclerotic plaques are surgically removed from
the carotid artery or arteries. Jd. Medical research
has demonstrated that, in patients with severe stenosis,
that is occlusion greater than 70 percent, carotid
endarterectomy reduces the risk of stroke. P. Ex. 50 at
3, P. Ex 51. Medical research has not demonstrated that
carotid endarterectomy benefits patients with less severe
occlusion. P. Ex. 51.

The professionally recognized standard for evaluating the
degree of a patient's carotid stenosis is to perform a
Doppler ultrasound of the carotid arteries, as a first
step. P. Ex. 51; Tr. at 113, 134, 500. If the Doppler
ultrasound indicates significant occlusion of the carotid
arteries, professionally recognized standards would
require that the precise degree of occlusion be confirmed
by angiography. P. Ex. 50 at 3, P. Ex. 51; Tr. at 500.
Angiography is an invasive procedure in which a contrast
material is injected into a patient's carotid arteries.
Tr. at 113, 496.

Petitioner does not dispute that professionally
recognized standards of care for a patient with TIA
possibly related to carotid stenosis require Doppler
ultrasound, followed up by angiography. Tr. at 500.
Instead, Petitioner argues that there was no reason to do
the Doppler ultrasound in this case because this patient
did not wish to consider surgical treatment.

Petitioner's Brief at 39 - 40.

As an initial matter, the record in this case is
equivocal as to whether the patient refused surgery or
whether Petitioner ruled out surgery. Petitioner
testified at the hearing that the patient refused
surgical treatment. Tr. at 494, 500 - 501. However,
75

Petitioner's written response to IPRO suggests that
Petitioner made the decision to rule out surgery. See
I.G. Ex. 22 at 4.% Nevertheless, whether it was
Petitioner or the patient who did not wish to consider
surgery, I would still conclude that Petitioner's failure
to order the Doppler ultrasound violated his duty to
provide care in accordance with professionally recognized
standards.

The standards of care are that carotid endarterectomy
surgery is the preferred treatment for patients with
carotid stenosis of 70 percent or more. P. Ex. 51. This
does not mean that every patient with 70 percent stenosis
will have surgery. Undoubtedly, there will be cases in
which patients refuse consent or surgery is ruled out for
other medical reasons. However, both the patient and the
physician need information about the degree of stenosis
in order to make a rational decision about the need for
surgery. Obviously, the calculus of risks and benefits
of surgery is different depending upon whether the
patient's carotid arteries are 20 percent or 90 percent
occluded. To make an informed choice, a patient with
severe stenosis of the carotid arteries needs to know
that the best chance to avoid a future stroke would be to
have surgery, even if that patient's ultimate decision is
to decline the surgery.

In this case, if it was Petitioner's decision to rule out
surgery, his failure to order the Doppler ultrasound
meant that he made that decision without an important
piece of diagnostic information. Petitioner argues that
he should not be faulted for choosing what the I.G.
acknowledges was the appropriate medical treatment for
the patient. Petitioner's Brief at 39. Petitioner
misses the point. While Dr. Sperling did testify that
Petitioner's treatment was the correct therapy for
someone who was a non-surgical candidate, he repeatedly
emphasized that a decision on the appropriateness of
surgical intervention could not be properly made without
initiating diagnostic tests evaluating the degree of
stenosis. Tr. at 113, 120 - 124, 135 - 136. Without
having the patient undergo the non-invasive Doppler study
and an angiography, depending on the Doppler results,
there is insufficient diagnostic information to conclude

2s At the IPRO hearing on November 10, 1992,
Petitioner testified that, based on an adverse result
from an endarterectomy of a brother of a patient of his,
and based on his research into the literature on this
surgery, he decided not to consider patient 060460 as a
surgical candidate. I.G. Ex. 6 at 148 - 149.
76

that oral medication therapy was the appropriate medical
treatment for this patient.

Moreover, I reject Petitioner's attempt to shield his
conduct by focusing almost exclusively on the risks of
surgical intervention as justification for his failure to
do the necessary diagnostic tests. The I.G.'s cited
violation does not address the issue of whether this
patient was an appropriate surgical candidate.
Consequently, I make no findings on the merits of having
this patient undergo a carotid endarterectomy. Neither
the I.G. nor IPRO ever specifically addressed this issue
since their concern was that Petitioner failed to do the
diagnostic tests that were necessary to make an informed,
knowledgeable decision on whether to undergo such
surgery. The evidence supports that such diagnostic
studies were a necessary element of this patient's
treatment and that Petitioner improperly failed to do
such studies. Therefore, I conclude that Petitioner
failed to meet professionally recognized standards of
health care because he embarked on that course of
treatment without obtaining the potentially significant
diagnostic information that the Doppler ultrasound could
have provided.

On the other hand, if it was the patient who was adamant
in his refusal of surgery, it still was incumbent upon
Petitioner to obtain the Doppler ultrasound, because more
specific information about the risks and benefits of
surgery might have led the patient to change his mind.
Moreover, nowhere in the medical record did Petitioner
document that he discussed the option of surgery with the
patient or that the patient refused surgical treatment.
Tr. at 616. This, in itself, would constitute a
violation of professionally recognized standards, if such
a conversation took place and it was not documented in
the record.

For these reasons, I conclude that Petitioner's failure
to order a Doppler ultrasound study of this patient's
carotid arteries before initiating treatment for his TIAs
was a substantial violation of his obligation to provide
care of a quality which meets professionally recognized
standards of health care.

Patient 060717

PRO Findings: Potential adverse patient effect when
patient discharged with instructions to take a
higher dosage of medication.
77

[I.G.}] Analysis: Dosage of cardiac medication was
changed in progress notes, but not on order sheet.
Discharge instructions reflect the higher dosage of
medication. The medical record shows discharge
summary with five mg Capoten BID, but do not show
any such medication being given during hospital
admission. The record does show Vasotec, 10 mg BID,
prior to discharge. Practitioner advised why he
lowered the dosage, which is not disputed by the
PRO.

[I.G.} Decision: The medical record supports the
PRO findings. This case will be retained as a
documentation failure.

My Analysis: This patient, a 69-year old male, was
admitted to Little Falls Hospital on December 2, 1991.
At the time of his admission, the patient's chief
complaint was acute dyspnea. He was diagnosed at that
time as having arteriosclerotic heart disease with acute
severe pulmonary edema, severe chronic obstructive
pulmonary disease, and mild renal insufficiency. I.6.
Ex. 23 at 11.

At the time of his admission, the patient had been taking
Capoten. I.G. Ex. 23 at 41. During his admission, on
December 3, 1991, the patient started to take Vasotec
instead of Capoten. I.G. Ex. 23 at 19; Tr. at 243 - 244.
Vasotec and Capoten are both ACE (angiotensin converting
enzyme) inhibitors which are used in the treatment of
hypertension and congestive heart failure. Tr. at 245.

The patient's initial dose of Vasotec was five
milligrams. Petitioner prescribed five milligrams of
Vasotec twice a day on December 3, 1991. He increased
the dosage later that day to five milligrams in the
morning and ten milligrams at night. I.G. Ex. 23 at 19;
Tr. at 244. On December 4, 1991, Petitioner increased
the dosage again, to ten milligrams twice daily, and this
was continued until the date of discharge. I.G. Ex. 23
at 20; Tr. at 244.

The patient was discharged on December 9, 1991. I.G. Ex.
23 at 21. Petitioner's progress notes of this date state
that the patient was to go home with a prescription for
five milligrams of Vasotec to be taken twice a day. I.G.
Ex. 23 at 25; Tr. at 244 - 245. However, the discharge
summary which was dictated by Petitioner on December 30,
1991, 21 days after the patient was discharged, contained
different information. It states that the patient was
discharged from the hospital on five milligrams of
Capoten to be taken twice a day. I.G. Ex. 23 at 14.
78

The Notice states that IPRO found that there were
potential adverse effects when this patient was
“discharged with instructions to take a higher dosage of
medication." In accepting the PRO findings set forth in
the Notice, it appears that the 1.G. is alleging that,
although Petitioner intended the patient to take the
lower dosage of five milligrams of Vasotec twice a day
after he returned home, he was in fact discharged with
instructions to take the higher dosage of ten milligrams
of Vasotec twice a day, which had been given to him in
the hospital prior to his discharge. I find that the
evidence does not prove this allegation.

The supporting analysis contained in the Notice states
that "({dJischarge instructions reflect the higher dosage
of medication." However, the patient's medical chart
does not include a discharge instruction sheet that
contains written instructions that had been given to this
patient prior to his discharge from the hospital. Tr. at
248, 251. The record is devoid of written discharge
instructions which support the I.G.'s allegation that the
patient was instructed to take the higher dosage of ten
milligrams of Vasotec twice a day at the time he was
discharged.

In addition, the record fails to establish that the
patient was orally instructed to take the higher dosage
of 10 milligrams of Vasotec twice a day at the time he
was discharged. To the contrary, the evidence
establishes that the patient was discharged with
instructions to take the lower dosage of five milligrams
of Vasotec twice a day.

Petitioner testified that he relies primarily on direct
contact with his patients with respect to discharge
instructions. Tr. at 514 - 515. Petitioner testified
that it was his practice prior to discharge to discuss
discharge instructions with the patient directly. He
testified that his patients receive prescriptions for the
medications they are to take at home directly from him,
in their rooms prior to discharge. Tr. at 504.

With regard to this patient, Petitioner testified that
he discussed his discharge instructions in the patient's
hospital room prior to his discharge. He stated that,
since the patient's wife maintained records of her
husband's medication orders, he discussed the discharge
instructions with both the patient and his wife.
Petitioner testified that the discharge instructions he
discussed with the patient and his wife were consistent
with the instructions documented on his December 9, 1991
progress note. He stated that he instructed the patient
79

to take five milligrams of Vasotec twice a day, and that
he wrote the prescription for this medication while he
was in the patient's room. Tr. at 503 - 504, 506.

I find credible Petitioner's testimony that he discharged
the patient with oral instructions to take five
milligrams of Vasotec twice a day. This testimony is
corroborated by Petitioner's contemporaneous progress
note documenting that the patient was to be discharged
with instructions to take five milligrams of Vasotec
twice a day. In the absence of evidence showing that the
patient received written instructions to take 10
milligrams of Vasotec twice a day, I find that the
evidence fails to establish that the patient was
discharged with instructions to take the higher dosage of
medication.

While the evidence fails to establish that the patient
was instructed to take the higher dosage of medication,
the discharge summary dictated by Petitioner on December
30, 1991, is not consistent with the final progress note.
It states that the patient was discharged with a
prescription to take five milligrams of Capoten twice a
day. No mention of Vasotec is made in the discharge
summary.

The PRO findings contained in the Notice do not
explicitly refer to this inconsistency, but the
supporting Analysis notes that the discharge summary
indicated that the patient was discharged on Capoten
rather than Vasotec. Reading the PRO findings together
with the supporting Analysis contained in the Notice, I
find that Petitioner was placed on sufficient notice that
the I.G. was alleging that Petitioner inaccurately
documented his treatment of the patient on the discharge
summary and that this documentation error was a basis for
the 1.G.'s determination to exclude Petitioner.

Petitioner testified that the statement in the discharge
summary that the patient was discharged on Capoten was an
error, and he acknowledged that the discrepancy between
his progress notes and the discharge summary might be
confusing to a physician attempting to treat the patient
if he was readmitted to the hospital. Tr. at 506 - 507,
509 - 510. Based on this testimony, I find that the
evidence establishes that Petitioner's documentation of
his discharge instructions is deficient insofar as the
discharge summary inaccurately documented the medication
the patient was given at the time he was discharged.

While Petitioner concedes that he made a documentation
error, he argues that it was a minor error. Petitioner
80

testified that there is no pill form of five milligrams
for Capoten. Tr. at 511. In view of this, Petitioner
argues that another physician reading the discharge
summary would be on notice that this notation on the
discharge summary was an error. In addition, Petitioner
argues that, since the discharge summary was dictated
several weeks after the patient was discharged from the
hospital, it did not influence what the patient was
actually instructed at the time that he was discharged.

I do not agree that the documentation error is
insubstantial. Even if another physician reading the
discharge summary realizes that there is no pill form of
five milligrams for Capoten, the physician would still
have some doubt as to the exact medication and dose that
the patient was directed to take at the time of his
discharge. Due to the confusing inconsistency between
the progress note and the discharge summary, another
physician would be required to expend his or her time to
resolve an issue that easily could and should have been
avoided if Petitioner had been more careful in his
documentation of treatment for this patient.

In isolation, such error by Petitioner is arguably not
significant. However, it takes on significance when
viewed in light of his record of failing to adequately
document patient records, despite his promise to do so in
his CAP in response to a prior PRO sanction action. If
anything, Petitioner should have been on notice to be
extra careful in his documentation.

The Analysis contained in the Notice states that the
"(ajosage of medication was changed in progress notes,
but not on the order sheet." This statement implies that
Petitioner's documentation of the dosage of medication
the patient was to take at home is deficient because it
does not appear on "the order sheet" as well as on the
progress notes.

The record contains a document captioned "Physician's
Orders." The entry for December 9, 1991 on that document
states only that the patient was to be discharged on that
date. No mention is made of medications the patient was
to take after he was discharged. I.G. Ex. 23 at 21. I
find that, while the evidence establishes that Petitioner
did not document his discharge instructions both in his
progress notes and on his physician order sheet, it fails
to establish that this constitutes a documentation
deficiency.

Dr. Nicholas testified that it was common procedure in
1991 that a patient released from a hospital would be
81

provided with written discharge instructions prepared by
the nursing staff. Tr. at 620 - 621. He stated also
that a nurse preparing a discharge instruction sheet
would expect to find a written description of the
physician's discharge instructions in the chart. Tr. at
624. However, he stated that whether this description is
written in the progress notes or on the physician order
sheet may vary depending on the local procedures in place
at a given hospital. Tr. at 623 - 624. The I.G. did not
offer any evidence to rebut this testimony.

The medical expert testimony does not support a finding
that a recognized standard of care requires Petitioner to
write the discharge instructions in the progress notes
and on the physician's order sheet. Furthermore, the
record is devoid of evidence showing that the patient
received written discharge instructions which were
incorrectly prepared by the nurses. To the contrary, the
evidence establishes that the patient received correct
oral discharge instructions in accordance with
Petitioner's progress notes. In view of the foregoing, I
find that Petitioner's failure to write discharge
instructions on his order sheet and in his progress notes
does not constitute a deficiency in his documentation of
his treatment of this patient.

Dr. Kops testified that most hospitals require that a
patient be given written discharge instructions when the
patient is released from the hospital. Tr. at 248. The
medical record in this case does not include a copy of
written discharge instructions that were given to this
patient. The I.G. argues in her brief that the absence
of written discharge instructions prepared for the
patient constitutes another documentation deficiency in
this case.

It is undisputed that the patient's chart in evidence
does not include a written discharge instruction sheet
prepared for him at the time of this discharge. During
the posthearing phase of these proceedings, the I.G.
contended for the first time that the fact that the
patient's chart does not include a discharge instruction
sheet is a basis for exclusion in this case. However,
this criticism is not included in the Notice. In fact,
the Notice alleges that the "[dJischarge instructions
reflect the higher dosage of medication." This suggests
that, at some point during the course of the proceedings
before IPRO, the record contained a discharge instruction
sheet that was reviewed by IPRO. Assuming that the chart
once included a discharge instruction sheet, Petitioner
cannot be faulted because this a@ischarge instruction is
no longer in the record made available for this
82

proceeding by the I.G. That is not Petitioner's
responsibility and cannot be construed as reflecting any
adverse impact on his meeting professional standards of
care. Even assuming such conduct was contrary to
professional standards of care, I find that the I.G. did
not adequately notify Petitioner of such allegation. For
the above reasons, Petitioner cannot be held accountable
for this allegation.

The I.G. argues also that Petitioner's documentation of
his treatment of this patient is deficient because "the
chart is devoid of any explanation for Dr. Burke's
frequent changes in the patient's cardiac medication."
I.G.'s Response at 22. During the hearing, the I.G.
attempted to pursue a line of questioning related to this
allegation. However, I pointed out that this allegation
was not encompassed by the allegations in the Notice.
Tr. at 246 - 247, 249. In view of the fact that
Petitioner did not receive adequate notice of this
allegation, he cannot be held accountable for it.

Patient 030053

PRO Findings: Failure to properly manage and treat
a diabetic patient.

[I.G.] Analysis: Patient had persistent

hypoglycemia which was not addressed. The medical
records show that the intravenous solution of 10%
dextrose in water was ordered "at rate to obtain
blood sugar above 80 then slow IV down to KVO for
the nite" (telephone order). The PRO noted that a
rate should be given; medical records show no rate
ordered. Orders should include checking blood
glucose level frequently, which were not ordered.

{I.G.] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

My Analysis: This patient was a 76-year old male who
suffered from diabetes mellitus. He was brought by
ambulance to the emergency room at Little Falls Hospital
on December 27, 1991, after an episode of coma induced by
his overdosing himself with 70 units of insulin that
morning. I.G. Ex. 24 at 12 - 13. The emergency medical
technicians reported that the patient's blood sugar was
33 mg/dL; the normal range for blood sugar is 80 - 120
mg/@L. I.G. Ex. 24 at 10; Tr. at 140. The emergency
medical technicians administered 50 percent glucose to
the patient, and by the time he reached the emergency
room, his blood sugar was 180 mg/dL and he was alert and
83

oriented. I.G. Ex. 24 at 10. He suffered another
episode of hypoglycemia in the emergency room and he was
admitted to the hospital for observation. Id. at 12.

In the hospital, the patient's blood sugar was recorded
at 4:30 p.m. as 77 mg/dL. Jd. at 32 - 33. The next
blood sugar level, which was 26 mg/dL, was recorded at
9:30 p.m. Jd. After that significantly low result was
obtained, the nursing staff administered orange juice and
Karo syrup. Jd. at 33. At 9:45 p.m. the patient's blood
sugar was 57 mg/dL. Jd. at 32 - 33. The nursing staff
again administered orange juice and Karo syrup. Id. at
33. At 10:15 p.m., the nursing staff telephoned
Petitioner to inform him of the patient's blood sugar
levels. Id. The nursing staff noted a telephone order
from Petitioner to "change IV solution to Dextrose 10% --
run at rate to obtain blood sugar above 80 then slow IV
down to KVO for the n{ight]." Id. at 14. The patient's

blood sugar was recorded as
There is no record that the
patient's blood sugar level

108 mg/@L at 10:30 p.m.
nursing staff checked the
again until 6:30 a.m. on

December 28, 1991, when the patient's blood sugar level
was 134. Id. at 32 - 33, 35.

The I.G. argues that Petitioner's treatment of this
patient failed to meet professionally recognized
standards of health care in two respects. First, the
I.G. contends that Petitioner's order to administer 10
percent dextrose to the patient was deficient in failing
to specify the rate at which the IV was to run. Second,
the I.G. alleges that Petitioner failed to order frequent
monitoring of the patient's blood sugar values. I
conclude that the I.G. proved that Petitioner failed to
meet professionally recognized standards of health care
in these two respects.

Dr. Sperling testified that the professionally recognized
standard of care for a diabetic patient with hypoglycemia
that was not stabilized requires the attending physician
to specify the rate at which IV dextrose is to be
administered. Tr. at 137, 139. In essence, Petitioner's
telephone order left to the nursing staff the
determination of what rate of flow would bring the
patient's blood sugar above 80. Dr. Nicholas testified
that, in the setting of a teaching hospital, it would be
acceptable for an attending physician to delegate to
house staff (i.e. medical residents) the decision as to
the rate for the IV. Tr. at 531 - 532. He opined that,
in a community hospital, such as the one at which
Petitioner practices, the nursing staff may take on
responsibilities performed by residents at larger
hospitals. Tr. at 532. Dr. Nicholas' testimony does not
84

provide evidence of significantly different
professionally recognized standards than those presented
by the I.G. expert. The testimony of Dr. Nicholas
supports the view that the determination of a flow rate
for IV dextrose is properly the province of a physician,
whether it be the attending physician or the medical
resident.”

I conclude that the I.G. proved that professionally
recognized standards of health care require that the
physician be responsible for ordering a flow rate for
administering Iv dextrose to a diabetic patient with
hypoglycemia. This Petitioner did not do. His
specification of a rate of KVO for the night once blood
sugar was above 80 was insufficient, as the crucial
decision required of Petitioner was the rate to be
administered to achieve a blood sugar of 80 mg/dL or
greater. Accordingly, Petitioner violated his duty to
provide care that met professionally recognized standards
in ordering the IV for this patient.

Petitioner failed also to order that the patient's blood
sugar be monitored at regular intervals. This, too, was
a violation of his duty to provide care that met
professionally recognized standards. The I.G.'s expert
testified that professionally recognized standards of
health care require a physician to order frequent
monitoring of a patient's blood sugar. Tr. at 138. He
testified further that it was not accepted practice to
monitor a hypoglycemic patient's blood sugar at five- or
six-hour intervals. Jd. Petitioner himself stated at
the September 28, 1993 IPRO hearing that it would be
appropriate to check blood sugar levels every hour or two
hours. I.G. Ex. 3 at 119 - 120. Nevertheless, there is
no indication in the medical record that Petitioner ever
gave orders specifying the frequency at which the nursing
staff should monitor the patient's blood sugar. In fact,
the patient's medical record reflects that, on the day of
admission, the patient's blood sugar dropped from 77 at
4:30 p.m. to 26 at 9:30 p.m., with no blood sugar levels
recorded during the five-hour interval. Presumably, had
more frequent monitoring been ordered, the patient's
falling blood sugar could have been counteracted before
it fell to such a low level. Again, after the patient's

26 Dr. Nicholas' testimony is not that the
nursing staff would have the responsibility to determine
the initial flow rate for the IV. Instead, the thrust of
Dr. Nicholas' testimony is that, in a community hospital,
it would be appropriate for the nursing staff to adjust
the flow rate, depending upon the patient's reaction.
85

blood sugar had recovered to a level of 108 at 10:30
p-m., his blood sugar was not monitored again until 6:30
a.m. the following morning, eight hours later.

Petitioner argues that the patient recovered and suffered
no permanent ill effects from his hypoglycemia.
Additionally, Dr. Nicholas testified that, even though
the patient's blood sugar level was not monitored, the
patient was sufficiently monitored by having the nursing
staff observe that he was alert and oriented at several
points during the night. Tr. at 537. However, the
nursing notes indicate that the patient was alert and
conversing well at the time the patient's blood sugar
level had fallen to 26 mg/dL. I.G. Ex. 24 at 33. For
this reason, it does not appear that the mere fact that
the patient was alert and oriented would rule out the
possibility of significant hypoglycemia. Moreover, the
fact that the patient recovered does not negate the
possibility that Petitioner failed to order the
appropriate treatment.” Therefore, I conclude that
Petitioner has not refuted the I.G.'s proof that
professionally recognized standards of care required him
to order monitoring of the patient's blood sugar at
regular intervals.

Thus, I conclude that Petitioner's failure to order a
rate for administering the IV dextrose and his failure to
order regular monitoring of the patient's blood sugar
were substantial violations of his obligation to provide
care of a quality which meets professionally recognized
standards of health care.

atiel 0303

PRO Finding: Failure to document discharge plans
for patient.

{I.G.] Analysis: The patient had a cardiac history
and was admitted in atrial fibrillation. Patient
was not discharged on coumadin or aspirin.

n On cross-examination, Dr. Sperling agreed that
the patient was monitored and treated and that his
hypoglycemia was reduced. Tr. at 145. The medical
record demonstrates that the patient was monitored and
received treatment and that his blood sugar returned to
normal. This in no way contradicts Dr. Sperling's direct
testimony that the patient's blood sugar was not
monitored at frequent, regular intervals during the day
and night of December 27 - 28, 1991.
86

Physician states coumadin was started on an
outpatient basis.

{I.G.} Decision: The medical records support the
PRO findings. This case is being retained as a
documentation failure.

My Analysis: This patient, a 76-year-old male, was
admitted to Little Falls Hospital on August 15, 1991,
with complaints of dyspnea, weakness and chest
discomfort. Petitioner diagnosed auricular fibrillation.
I.G. Ex. 25 at 7, 13, 15.% On August 20, 1991, the
patient was started on Heparin, an intravenous
anticoagulant medication. I.G. Ex. 25 at 11, 19; Tr. at
277. Petitioner consulted another doctor from Little
Falls Hospital, Dr. Apone. In his consultation report,
Dr. Apone advised Petitioner to "stop the IV Heparin and
see if the patient can be maintained chest pain free just
on Aspirin and antiplatelet therapy and possibly with
addition of Persantine." I.G. Ex. 25 at 27.

Petitioner discharged the patient 10 days after admission
with instructions to follow a low sodium diet and to take
Vasotec, Lasix, and Isosorbide. Petitioner instructed
him also to return to Petitioner's office for a follow-up
visit. I.G. Ex. 25 at 11, 25, 76. There is no
indication on the medical chart that Petitioner
instructed the patient to take Coumadin at the time that
he was discharged. Petitioner states, however, that
Coumadin was started on an outpatient basis. I.G. Ex. 25
at 4; I.G. Ex. 3 at 42; I.G. Ex. 6 at 206.

Petitioner wrote discharge instructions in his
handwritten notes of August 25, 1991. I.G. Ex. 25 at 25.
He wrote also the discharge instructions in his
typewritten notes of September 18, 1991. I.G. Ex. 25 at
11. A nurse filled out the discharge instructions which
were given to the patient, and, in accordance with
customary practice, based the instructions on

38 Petitioner's progress notes indicate that the
patient was admitted with auricular fibrillation, and Dr.
Kops testified that the patient was admitted with atrial
fibrillation. Apparently, the two terms are used
synonymously. Dr. Kops defined atrial fibrillation as:
"an uncoordinated activity of the atrium. The heart
loses its efficiency to pump. Because of atrial
fibrillation, there's stagnation of blood flow in the
heart." Tr. at 276. Since Petitioner did not contest
this definition, I accept it as true.
87

Petitioner's progress notes. Tr. at 286; I.G. Ex. 25 at
76.

The nurse's discharge instructions mirror Petitioner's
progress notes, with the exception of an additional
instruction for the patient to take Digoxin. I.G. Ex. 25
at 76. Dr. Kops indicated that the nurse's variance from
Petitioner's progress notes was probably due to the fact
that the patient had been given Digoxin up until the time
of discharge and that this prescription would be noted in
the medication record. Tr. at 287. The patient visited
Petitioner a week to 10 days after discharge. Petitioner
noted in his typewritten progress notes that the patient
"still had auricular fibrillation, which increased
abnormally with effort." I.G. Ex. 25 at 11.

The I.G. contends that Petitioner substantially violated
professionally recognized standards of care by his
failure to document the prescription of Coumadin in the
discharge plans for the patient. I.G.'s Brief at 56 -
57. Dr. Kops testified that the standard of care for
anti-coagulating a patient is to start the patient on
Heparin while in the hospital. He stated that Coumadin
should then be started while the patient is on Heparin
and while the patient is still in the hospital and
adequately anti-coagulated. He explained that Heparin is
only discontinued once the Coumadin has achieved its
desired effect, and that it takes several days for the
Coumadin to do so. He stated that a prothrombin test is
used to measure whether the Coumadin is within a
satisfactory range. Tr. at 277 - 278.

In response to questions regarding Petitioner's failure
to document the prescription of Coumadin in the discharge
plans for the patient, Dr. Kops explained how the
discharge instructions are given. Dr. Kops indicated
that customary practice is for the attending physician to
write his discharge instructions in the medical chart.

He explained that the nurse who discharges the patient
will include the doctor's instructions in the discharge
instruction sheet which is given to the patient. Tr. at
285 - 287. In this case, in addition to the medications
prescribed by Petitioner in his progress notes, the nurse
included an additional medication which was not listed in
Petitioner's notes. I.G. Ex. 25 at 25, 76. As I stated
earlier, Dr. Kops explained that the nurse could have
included this medication in the discharge summary on the
basis of the medication history and the fact that the
patient was on this medication up until discharge. Tr.
at 287.
88

Petitioner did not refute the I.G.'s definition of the
recognized standards of care. Moreover, Petitioner
conceded the documentation error, and asserted that he
“is currently documenting discharge medications in the
medical chart. Petitioner's Brief at 56 - 57.

Petitioner contends, however, that the allegation that he
never prescribed Coumadin for this patient went beyond
the scope of the PRO finding that he had failed to
document any prescription for Coumadin. Petitioner
asserts that he prescribed Coumadin for the patient on an
outpatient basis, and he told IPRO this at the 1992 and
1993 IPRO hearings and in his Physician Response to the
IPRO reviews. I.G. Ex. 25 at 4, I.G. Ex. 3 at 42, I.G.
Ex. 6 at 206.

The issue of whether Petitioner prescribed Coumadin to
this patient after he was discharged goes beyond the
scope of this case. IPRO found that Petitioner had
failed to document the prescription of Coumadin in his
discharge notes. IPRO did not make any findings with
regard to whether Petitioner failed to prescribe
Coumadin.

With regard to the allegation that Petitioner did not
adequately document his discharge plans, the record shows
that recognized standards of care required him to
document his discharge instructions in the medical chart.
Neither Petitioner's handwritten or typewritten progress
notes include an instruction that Coumadin be prescribed
to the patient upon discharge. I.G. Ex. 25 at 11, 25.

As a result of Petitioner's failure to document a
Coumadin prescription, the discharging nurse was unaware
that the patient should be anti-coagulated with Coumadin.
The nurse's discharge instructions to the patient do not
include a prescription for Coumadin. I.G. Ex. 25 at 76.
Petitioner admits that he made a documentation error and
he claims that he is now documenting instructions for all
discharge medications. Based on the foregoing, I find
that Petitioner's failure to document his intent to
prescribe Coumadin to this patient on discharge is a
substantial violation of his obligation to provide
necessary documentation of his care of the patient.

Patient 039069

PRO Findings: Failure to document omission of a
diagnostic test.

[I.G.} Analysis: Patient admitted with vertigo and
a history of atrial fibrillation (for which he was
receiving anticoagulation), a recent 25-pound weight
loss and fatigue. A complete blood count was not
89

done on admission. The test was performed prior to
admission and was reportedly within normal limits.
However, the omission of the test at admission, and
the reason for omission are not clear. The failure
to provide documents showing prior recent complete
blood counts is applicable.

{I.G.] Decision: The medical records support the
PRO findings. This case is being retained as a
documentation failure.

is: This patient was a 76-year-old male who was
admitted to Little Falls Hospital with complaints of
vertigo and nausea. I.G. Ex. 26 at 9 - 10. Upon initial
examination, Petitioner found that the patient had
generalized arteriosclerosis with acute episodes of
vertigo; mild organic brain syndrome; and
arteriosclerotic heart disease with ongoing auricular
fibrillation and cardiac prominence. I.G. Ex. 26 at 9.
Petitioner noted in his progress notes that the patient
had been under the care of several physicians in the area
for cardiac and orthopedic care, but there is no mention
of any contact with these physicians during his
admission. Id. There is no documentation in the
patient's admission record of a CBC. There is also no
explanation in the admission record as to why a CBC was
not done on admission, nor are the results of a prior CBC
documented. I.G. Ex. 26.

The I.G. did not offer any direct testimony at the
hearing in support of the PRO findings. Instead, the
1I.G. contends that the record substantiates the PRO
findings set forth in the Notice. Petitioner did not
present any testimony either.

The I.G. argues that Petitioner's failure to document
in this case is an example of the deficiencies that
Petitioner's CAP was intended to correct. I1.G.'s Brief
at 60 - 61. The I.G. contends that this failure to
document is one of a number of events, which together
demonstrate a pattern of practice by Petitioner, which
fails to conform to professionally recognized standards.

id.

Petitioner admitted that his failure to do a CBC on
admission was an oversight. I.G. Ex. 26 at 4, I.G. Ex. 6
at 182. He stated that he now performs a CBC as part of
the routine admission blood tests he orders to be
performed on all of his patients. I.G. Ex 6 at 183;
Petitioner's Brief at 89. Petitioner asserted also that
the patient had a CBC done approximately seven days
before admission. I.G. Ex. 3 at 23. However, Petitioner
90

did not offer any explanation for his failure to document
the omission of a CBC on admission, or for his failure to
document an explanation for the omission. Moreover,
Petitioner did not explain why he failed to include in
the medical record the results of the previous CBC.

Although Petitioner concedes that his failure to obtain
the CBC on admission was an oversight, he attempts to
reduce the significance of the violation by relying on:
1) a comment made by an I.G. medical advisor that the
inclusion of this patient's case as a documentation
rather than a quality of care failure seemed
inappropriate; and 2) the fact that IPRO's physician
reviewer reduced his rating of the violation from Level
II to Level I. Petitioner's Brief at 89 - 90. An I.G.
medical advisor stated that documentation of a CBC in
this case would be necessary only if the CBC itself was
necessary. I.G. Ex. 29 at 7. Petitioner argued also
that he did not get fair notice and the opportunity to be
heard on the I.G.'s contention in her brief that this
deficiency was one of several deficiencies that the CAP
was intended to address. Petitioner's Response at 23 -
24.

Petitioner's reliance on one statement by the I.G.'s
medical advisor is without merit. The medical advisor's
concern was IPRO's selection of the nature of the
violation. He suggested that the omission of the test
was a quality of care violation rather than a
documentation failure. He opined that, if IPRO did not
find it to be a quality of care violation, then arguably
failure to document the test was not a documentation
violation. However, he acknowledged that, despite his
concerns, the I.G. could agree with IPRO because of the
wide latitude of the PRO documentation standards. I.G.
Ex. 29 at 7. A second analysis performed for the I.G.
concluded also that the CBC was necessary at admission.
I.G. Ex. 30 at 11. So, at best, Petitioner is quibbling
with the I.G.'s choice as to the type of violation. The
record supports that the CBC was necessary at admission.
Thus, Petitioner is advantaged by the I.G. choosing the
lesser violation of documentation failure.

Petitioner's argument that he was not given proper notice
or an opportunity to be heard is also without merit. The
Notice makes specific reference to the CAP. The Notice
alleges that the cited cases, including those reflecting
documentation problems, establish that Petitioner's
pattern of practice with regard to treatment of patients
has not improved in spite of the CAP. Notice at 10.
91

Upon review of the record, I find that Petitioner's
failure to document that he did not perform a CBC on this
patient at the time he was admitted, his failure to
explain why he did not perform a CBC on admission, and
his failure to document the results of the CBC performed
prior to admission, is a substantial violation of
Petitioner's obligation to provide necessary
documentation of care.

Patient 037680

PRO Findings: Failure to perform a procedure with
consent. Failure to document in the medical record
the diagnosis, procedure and the lack of fluid
analysis.

[I.G.}) Analysis: Patient admitted for organic brain
syndrome with hallucinations. Arthrocentesis of the
right knee was performed. Medical records provided
do not contain a consent for this procedure, neither
do they contain a general hospital consent form or
procedure note.

[I.G.}] Decision:
PRO findings, and the findings are upheld.
of care violation)

The medical records support the
(Quality

My Analysis: Patient 037680, an 85-year-old female, was
admitted to Little Falls Hospital on August 21, 1991.

The patient's chief complaint at the time of admission
was that she was having hallucinations. In the hospital
admission report, Petitioner stated that the patient had
some insight into her problem, but that the
hallucinations had a considerable reality to her and were
quite disturbing. The patient had a brother who lived
nearby. I.G. Ex. 27 at 5 - 6.

At the time of the patient's
Petitioner diagnosed organic
hallucinatory and delusional
Petitioner reported that his
patient revealed evidence of
knees, and he noted that the
inflamed. I.G. Ex.

admission to the hospital,
brain syndrome with

state. In addition,
physical examination of the
bilateral arthritis of both
right knee was acutely

27 at 5 - 6.

During her hospitalization, the patient was disoriented
at times. The nursing notes describing her condition
from August 21 through August 23, 1991 reveal that she
alternated between being confused and being lucid. At
times, she did not realize that she was in the hospital
and at other times she was oriented and gave appropriate
verbal responses. I1.G. Ex. 27 at 56, 59 - 61.
92

On August 23, 1991, Petitioner performed an
arthrocentesis of the patient's right knee. This is an
invasive procedure, which involves inserting a needle
into a patient's knee and withdrawing fluid. I.G. Ex. 27
at 61; Tr. at 149 - 151, 223. Petitioner's progress
notes describe the procedure and its results as follows:
"Tapped Rt{right] Knee ~ Old Blood - Hemarthrosis." I.G.
Ex. 27 at 19. There is no consent form for the procedure
in the patient's medical chart.

Within 45 minutes after this procedure was performed, the
patient began to cry and stated that she saw snakes
coming out of the box containing needles. The patient
stated that, although she knew the snakes were not real,
she nevertheless could still see them. I.G. Ex. 27 at
61. The patient reported seeing snakes the next day.
I.G. Ex. 27 at 65.

During the course of her hospital stay, the patient was
treated with insulin, and her hallucinations improved.

On September 10, 1991, the patient was discharged from
the hospital to the County Home for ongoing care. At the
time of discharge, the patient had achieved mental
equilibrium. I.G. Ex. 27 at 25, 26.

IPRO made several findings with respect to this patient,
and I will discuss each in turn.

Failure to perform procedure with consent

The record establishes that professionally recognized
standards of health care require that a physician obtain
informed consent prior to performing an invasive
procedure on a patient. Arthrocentesis is an invasive
procedure which requires informed consent. Tr. at 149 -
150.

The professionally recognized standards regarding the
process for obtaining informed consent require the
physician to explain the purpose of the procedure, how it
will be performed, the possible benefits of the
procedure, and the possible complications of the
procedure. In addition, the patient should be given the
opportunity to ask questions of the physician. Tr. at
300.

If the patient is incapable of understanding information
pertaining to the procedure, the procedure should be
explained to an adult who is the closest relative to the
patient. Consent to perform the procedure should be
obtained from that individual. Tr. at 151.
93

In this case, Petitioner does not dispute that he was
required to obtain informed consent prior to performing
arthrocentesis. In addition, Petitioner does not dispute
that he failed to obtain written informed consent for
this procedure. While Petitioner admits that he erred in
not adequately documenting the fact that he obtained
informed consent, he contends that he obtained the
requisite informed consent orally from this patient.

I find that the weight of the evidence establishes that
Petitioner did not obtain informed consent from this
patient.

The undisputed evidence establishes that the patient's
chief complaint at the time she was admitted to Little
Falls Hospital was that she was experiencing
hallucinations. During the two day period from the time
she was admitted until the time the arthrocentesis was
performed, she alternated between being disoriented and
lucid. In addition, she was delusional within one hour
of the arthrocentesis.

Dr. Nicholas testified that the fact that the patient was
experiencing hallucinations alone does not necessarily
mean that she was not capable of giving informed consent
for the arthrocentesis. He expressed the view that it is
possible to experience hallucinations about certain
limited aspects about what is going on, but still be
capable of understanding the benefits and risks
associated with a medical procedure. Tr. at 561.

I accept Dr. Nicholas' testimony that the fact that the
patient was delusional does not automatically mean that
she was incapable of providing informed consent. I
recognize that the evidence does not definitively
establish that the patient was not competent to provide
informed consent. Indeed, the evidence shows that she
had some insight into her problem and realized that the
hallucinations were not real. Nevertheless, I am
troubled by the evidence regarding the patient's mental
condition. At the least, the evidence regarding the
patient's changing mental status creates some doubt about
her ability to understand the procedure and to give
informed consent.

At the hearing before me, Petitioner testified that the
patient's hallucinations "didn't leave her psychotic" and
that on the day the procedure was performed, the patient
was "quite lucid." Tr. at 231. He testified that the
patient's knee was swollen and hot. According to
Petitioner, the patient "was advised that she would
probably improve symptomatically if she had the fluid
94

removed from her right knee. She said, all right." Tr.
at 223. Petitioner stated that he did not make any
attempt to contact the patient's brother in order to
obtain consent. Tr. at 231.

In addition, Petitioner testified that the practice at
Little Falls Hospital in 1991 was that the physician had
the responsibility to make sure that the patient was
agreeable to having a procedure performed. He stated
that consent forms were not always signed in 1991, and if
they were, the nurses typically took care of it. Tr. at
225, 230,

I am not persuaded by Petitioner's testimony that the
patient gave informed consent in this case. While
Petitioner claims that he discussed the procedure with
the patient and that she agreed to it, there is nothing
in the record to substantiate that the patient was fully
informed of her condition, of the need for the procedure,
and of the risks attendant to it. The record is devoid
of evidence corroborating Petitioner's assertion that the
patient knowingly approved of the procedure. There is no
signed consent form, nor is there any contemporaneous
notation either in Petitioner's progress notes or the
nursing notes indicating that the procedure was even
discussed .with the patient. Also absent from the record
is testimony from a nurse who may have witnessed the
patient consenting to the procedure. I am not convinced
by Petitioner's self-serving, unsubstantiated assertion
that he obtained informed consent, particularly in light
of the undisputed evidence showing that the patient had
periods of confusion and hallucinations on the day the
procedure was performed.

Moreover, statements made by Petitioner in the September
28, 1993 hearing before IPRO suggest that the patient was
not fully informed about the procedure. Petitioner
stated in that hearing that, while he told the patient
what he was going to do, he did not explain the procedure
in detail. He stated that the patient was "a very
compliant individual" and that he did not "think she
would have understood a full explanation." I.G. Ex. 3 at
52. These statements undermine Petitioner's assertion
that the patient gave "proper consent." Id.

Based on the totality of the circumstances of this case,
I conclude that Petitioner did not obtain informed
consent from this patient. This is a substantial
violation of Petitioner's obligation to provide care of a
quality that meets professionally recognized standards of
care.
95

Petitioner's violation of this obligation is a serious
offense. Dr. Nicholas acknowledged in his testimony that
the right of a patient to be fully informed about the
treatment being recommended and to refuse that treatment
is a "basic" right of patients. Tr. at 563. In
addition, this right is codified in the Patients' Bill of
Rights given to patients admitted to hospitals in New
York State. I.G. Ex. 27 at 111. Petitioner's failure to
obtain informed consent from one of his patients shows a
disturbing indifference to the fundamental rights of
patients.

Even if I were to construe the facts in favor of
Petitioner and find that he obtained informed consent
from this patient orally, which I do not, I would still
find that Petitioner committed a substantial violation of
his obligation to document the quality of his care based
on his failure to describe such consent in the written
record of the patient's treatment.

Petitioner argues that obtaining written consent is not
required under the laws of the State of New York in order
for oral consent to be valid. Petitioner's Response at
11. Since I find that Petitioner did not obtain consent
orally, I do not need to address the issue of whether
written consent is necessary for oral consent to be
valid. Moreover, even assuming that written consent is
not necessary for oral consent to be valid, I still find
that failure to document that valid oral consent was
obtained is a violation of professionally recognized
standards of care.

Even Petitioner admits that documenting the patient's
oral consent would have been "the better practice."
Petitioner's Response at 11. In addition, during the
first IPRO hearing on November 10, 1992, Petitioner
admitted that he was "absolutely wrong" in not making
sure that the patient signed a written consent form
before Petitioner performed the arthrocentesis. I.G. Ex.
6 at 99.

Dr. Nicholas testified that the professionally recognized
standard of care is to obtain written consent to document
that the physician has discussed the procedure with the
patient and that the patient has given oral informed
consent. Tr. at 563 - 565. Dr. Nicholas further
testified that while oral consent is obtained before
written consent, he teaches his students to obtain
written consent. Tr. at 564 - 565. Both Drs. Kops and
Sperling testified that oral consent should not be
obtained from a patient with changes in mental status.
Tr. at 151, 301. Dr. Sperling testified that, under such
96

circumstances, he would obtain consent from a relative
and that, if only oral consent could be obtained from the
relative, he would document such consent in the patient's
record. Tr. at 151 - 152.

Petitioner's failure to document the record is especially
egregious in this case because of the patient's changing
mental state. Based on her compromised mental state,
this patient was totally dependent on Petitioner to
determine whether she was sufficiently lucid to give
informed consent. In the event that the patient was too
confused to give informed consent, Petitioner was
obligated to obtain consent from a relative.

Petitioner chose not to discuss the patient's treatment
with her brother, and, as a result, the patient's brother
could not exercise any judgment for her. Under
circumstances such as these, when a patient's capacity to
give informed consent is open to question, it is
particularly important for the attending physician to
document that the physician had a full discussion of the
treatment alternatives with the patient and that based on
this discussion, the patient knowingly gave consent to
the procedure. As previously stated, no such
documentation exists in this case.

Failure to document the diagnosis

This patient was treated during her hospital stay for
more than one condition. The PRO finding that Petitioner
failed to document the diagnosis refers to the patient's
right knee condition for which the arthrocentesis was
performed.

Petitioner testified that the fluid removed from the
patient's right knee "turned out to be old degenerated
blood." Tr. at 223. He stated that the fluid was "just
dead blood which was a complication of her arthritis.
It's not too unusual." Tr. at 224, Petitioner contends
that he documented his diagnosis of the patient's right
knee condition in his August 23, 1991 progress note which
reads, "Tapped Rt{right] Knee - Old Blood -
Hemarthrosis." I.G. Ex. 27 at 19. He contends that
hemarthrosis is his documented diagnosis. Petitioner's
Brief at 70.

Dr. Nicholas' testimony supports Petitioner's contention.
He stated that "hemarthrosis is a diagnostic term
indicating that blood was found in the knee joint. you
can't make that diagnosis without having obtained blood
in the -- old blood was what was obtained." Tr. at 557.
The testimony of the I.G.'s expert witness, Dr. Sperling,
97

is consistent with this. He testified that hemarthrosis
is a diagnosis meaning blood in the joint. Tr. at 160.

I conclude that the expert medical testimony establishes
that Petitioner diagnosed the patient's medical condition
based on his observations of the fluid withdrawn from her
knee and that he documented this diagnosis in the
patient's chart.

While it is clear that Petitioner documented his
diagnostic impression after he performed the
arthrocentesis, there is a remaining question as to
whether he should have taken additional steps in order to
make a more complete and informed diagnosis. Dr.
Sperling testified that obtaining a laboratory analysis
of the fluid was necessary to "find out what you are
dealing with; what's the diagnosis." Tr. at 163. Thus,
Dr. Sperling's testimony suggests that hemarthrosis was a
properly documented diagnosis based on the available
information immediately following the arthrocentesis, but
that it is not necessarily a final or complete diagnosis
based on all the tests that should have been performed.
Since the issue of whether Petitioner documented a final
and complete diagnosis is interrelated with the issue of
whether he should have performed a fluid analysis, I will
address it in the context of my discussion of the lack of
fluid analysis.

Failure to document the procedure

IPRO found also that Petitioner failed to document the
procedure that was performed. The Analysis supporting
this allegation states that the medical record does not
contain a procedure note.

Petitioner contends that his August 23, 1991 progress
note which reads, "Tapped Rt{right] Knee - Old Blood -
Hemarthrosis" documents the procedure which was performed
on this patient. Petitioner's Brief at 70. The I.G.
contends that this is not a sufficient description of the
procedure performed on the patient to meet accepted
professional standards. I.G.'s Brief at 37 - 38.

Dr. Kops testified that, if an invasive procedure is
performed at bedside, then the attending physician should
write a procedure note for the chart. Tr. at 301. Dr.
Kops stated that a procedure note should contain the
following:

. « . the indication for the procedure, the
procedure then should be specified. Whatever
preparation made of the skin. If a local anesthetic
98

is used, that should be documented. And the
procedure itself should be documented, the technique
used, and the physician should comment on how the
patient tolerated the procedure after it's
completed.

Tr. at 301 - 302.

Dr. Sperling's testimony was consistent with Dr. Kops'
testimony. Dr. Sperling stated that a procedure note
should describe how the procedure was performed. He
stated that, if the procedure is arthrocentesis, the
procedure note should describe the fluid that was
obtained. Dr. Sperling opined that while the words
"tapped right knee" is indicative of the fact that
arthrocentesis was performed, it does not describe how
the procedure was performed in sufficient detail to
comport with recognized professional standards. He
stated that the words "old blood" do not meet the
standard of practice in describing the fluid that was
drained from the knee because it does not indicate
characteristics such as the fluid's viscosity, turbidity,
whether it clots, whether there is evidence of pus, how
thick it was, how much was obtained, and whether there
was an odor. Tr. at 160 - 161.

I find the testimony of these expert witnesses to be
persuasive. This testimony establishes that
professionally recognized standards of care require: that
a physician write a procedure note for invasive
procedures, such as arthrocentesis, performed at bedside.
This requirement is not fulfilled by simply writing in
the chart that a procedure was done. Instead, the
procedure note should contain a comprehensive description
of the indication for the procedure, the procedure
itself, and the results.

Petitioner's August 23, 1991 entry in the chart does not
meet this standard. While this entry documents that
arthrocentesis was performed and that old blood was
obtained, it does not describe the procedure and the
results in sufficient detail to meet the professionally
recognized standard of care as set forth by Dr. Kops and
Dr. Sperling.

Petitioner has not brought forward convincing evidence to
rebut the testimony of the I.G.'s expert witnesses. His
responses to IPRO charges are inconsistent and
unpersuasive.

Petitioner initially responded to the IPRO charge that he
did not describe the procedure adequately by stating that
99

a “procedure note is not required for a procedure of a
limited extent accomplished in the patient's room. In
the Emergency Room or Surgery, then a note is required."
I.G. Ex. 27 at 4. By defending himself against IPRO's
charge in this manner, he implicitly admitted that the
entries he made in the chart do not constitute a detailed
procedure note. Instead, he argues that he was not
required to write a detailed procedure note since the
procedure was performed at bedside in a non-emergency
situation.

However, in the November 10, 1992 hearing with IPRO,
Petitioner stated that there were "not enough words" in
his August 23, 1991 entry. I.G. Ex. 6 at 100. In making
this statement, Petitioner appears to be saying that he
recognizes that he was required to document the procedure
in greater detail, but that he failed in his obligation
to do so.

Petitioner's position changed again in the proceedings
before me. Dr. Nicholas, his expert witness,
characterized the August 23, 1991 entry as a procedure
note which documented the procedure and what was found.
Tr. at 559 - 560. Petitioner's argument in his
posthearing briefs was consistent with Dr. Nicholas’
testimony. He abandoned his argument that a procedure
note is not required for a procedure performed at
bedside. In addition, he no longer contended that there
were "not enough words" in the August 23, 1991 entry.
Instead, he took the position that the August 23, 1991
entry adequately documented the procedure.

In view of the inconsistencies in Petitioner's
statements, I find that Petitioner has not overcome the
evidence adduced by the I.G. Even Dr. Nicholas’
testimony does not directly rebut the testimony of the
I.G.'s expert witnesses. While Dr. Nicholas stated that
the August 23, 1991 entry was a "very concise description
of what happened," he does not explicitly disagree with
Dr. Kops' and Dr. Sperling's testimony regarding the
requirements for a full and complete procedure note. Tr.
at 557. I do not agree with Dr. Nicholas that
Petitioner's cryptic procedural note meets the
professionally recognized standards of care. A simple
comparison of what Petitioner wrote in his note and of
the required description of the procedure reflected in
the I.G.'s experts' testimony demonstrates the inadequacy
of Petitioner's documentation of the procedure.

In view of the foregoing, I find that the preponderance
of the evidence rests with the testimony of Dr. Kops and
Dr. Sperling. This evidence establishes that
100

Petitioner's failure to document adequately the procedure
performed on this patient was a substantial violation of
professionally recognized standards of health care.

Lack of Fluid Analysis

IPRO found also that "the lack of fluid analysis"
violated Petitioner's obligation to provide care that
meets professionally recognized standards of care.

In support of this PRO finding, the I.G. offered the
testimony of Dr. Sperling. Dr. Sperling testified that
professionally recognized standards of care and State law
require that every time fluid is withdrawn from a knee
joint in the course of an arthrocentesis, samples of that
fluid should be sent to a pathology laboratory for
analysis. Tr. at 161 - 163. According to Dr. Sperling,
the laboratory:

can spin out the blood, see whether or not they get
cells any number of ways, what their culture and
sensitivities are, what the gram stains [are]...

Tr. at 162. Dr. Sperling stated that the purpose of
obtaining a laboratory analysis of the fluid is to "find
out what you are dealing with; what's the diagnosis" and
he indicated that the results of the laboratory analysis
are typically documented in the record. Tr. at 162 -
163. Dr. Sperling stated that there are no exceptions to
this requirement. In particular, he testified that this
requirement is not obviated by the fact that the
withdrawn fluid is described by the attending physician
as being "old blood." He asserted that the fact that
Petitioner indicated that the withdrawn fluid was old
blood "doesn't mean anything" because "[yJou can still
have an infection with old blood." Tr. at 157.

Dr. Sperling's testimony is supported by the Merck
Manual. The Merck Manual includes a Table setting forth
an outline for performing arthrocentesis. That table
sets forth detailed instructions for handling the
withdrawn fluid in preparation for laboratory tests. The
Merck Manual indicates that the proper aspiration of
fluid and its preservation for laboratory analysis is a
critical step in the diagnostic process. While the Merck
Manual states that "{njot all tests need to be done on
each fluid," it does not state anywhere that laboratory
tests need not be performed on "old blood." e: anual
(4th ed. 1982) at 1174. Indeed, the Merck Manual
expressly notes that the specimen may be hemorrhagic, and
that this suggests fracture or malignancy. In addition,
the Merck Manual states that intensely inflammatory
101

effusions suggest pyogenic infection. The Table
containing the outline for performing arthrocentesis
specifically states that, if infection is considered a
possibility, the fluid should be placed immediately in a
sterile tube for routine cultures. Merck Manual (14th
ed. 1982) at 1174 - 1176; (15th ed. 1987) at 1231.

Petitioner does not dispute that, as a general rule, a
physician should send blood withdrawn from a knee joint
to a laboratory for analysis. However, he asserts that,
under the circumstances of this case, he was justified in
discarding the fluid without sending it to a laboratory
for analysis.

Petitioner testified that the substance he removed from
this patient was old, degenerated blood. He stated that
he did not send it for laboratory analysis because lab
values such as cell counts and proteins are not
interpretable on old blood. Tr. at 223 - 224.
Petitioner's testimony is deficient because he does not
adequately explain the basis for his conclusion that this
fluid had degenerated to the point that sending it for
analysis would yield meaningless results. Petitioner
does not describe a recognized objective standard that is
used to determine whether a withdrawn fluid has the
characteristics which would justify throwing it away
without analysis. In addition, Petitioner does not
describe the fluid he actually withdrew with sufficient
specificity to ascertain whether it possesses those
characteristics. It is noteworthy that the Merck Manual
classifies fluids based on viscosity, color, and clarity.
While Petitioner's progress note states that he withdrew
“old blood," it does not describe the viscosity, color,
and clarity of the withdrawn fluid.

Moreover, even Petitioner equivocated on the issue of
whether the fluid he withdrew from this patient would
have produced results which were not interpretable. In
the September 28, 1993 hearing before IPRO, Petitioner
stated that even though the withdrawn fluid was old
blood, a "culture could have been done." I.G. Ex. 3 at
51 - 52. This statement is inconsistent with his
subsequent statement that he was justified in his
decision not to obtain any laboratory tests on this
fluid, and it undermines his credibility. Tr. at 223 -
224.

Dr. Nicholas did not dispute that, as a general rule, a
physician would send fluid withdrawn from a knee to a
laboratory for analysis. However, he asserts that an
exception to this general rule should be made under the
circumstances of this case.
102

Dr. Nicholas opined that “once you've decided this is a
hemarthrosis with old blood in it, any of the numbers you
get back, either high or low, would be not
interpretable." Tr. at 558. He acknowledged that
ordinarily measuring protein is an important thing to do
in a joint fluid. However, he stated that old blood has
"disintegrated lysate cells in it which would contribute
to the fluid in general and elevate the protein some, and
make the protein analysis not really helpful." Id. In
addition, he stated that "blood simply being in the joint
can incite a white cell response." Jd.

Dr. Nicholas reasoned that “one shouldn't send a lab test
if the results are not going to be interpretable. And
that rule certainly overrides the general rule, the
general rules about what you should with any -- you know
-- with either the fluid or the specimen or with what you
would ordinarily do." Tr. at 558 - 559. Dr. Nicholas
asserted that obtaining tests that have no potential to
give interpretable results is wasteful and potentially
misleading. Tr. at 559.

I am not persuaded by Dr. Nicholas' testimony. While Dr.
Nicholas asserts the cellular components of blood can
disintegrate to the point that a laboratory analysis of
the blood would be meaningless, he does not offer an
objective standard to determine when the blood has
disintegrated to that point. Instead, he relies merely
on Petitioner's conclusory statement that the withdrawn
blood was "old."

Moreover, the record is devoid of evidence showing that
either Dr. Nicholas or Petitioner possess the expertise
to offer an opinion on the issue of whether the withdrawn
fluid has disintegrated to the point that laboratory test
results would be meaningless. It is noteworthy that Dr.
Kops declined to offer an opinion on this issue on the
grounds that he is "not a rheumatologist." Tr. at 308.

Based on the foregoing, I conclude that the weight of the
evidence establishes that professionally recognized
standards require that fluid withdrawn from a knee in the
course of arthrocentesis should be sent for laboratory
analysis. I find also that the evidence adduced by
Petitioner fails to establish that an exception to this
general rule was justified under the circumstances of
this case. In view of the fact that Petitioner failed to
obtain the requisite laboratory tests on the withdrawn
fluid, I find that he did not take all the necessary
steps to make a final and complete diagnosis. In the
absence of the fluid analysis, Petitioner did not
establish that his preliminary diagnosis was accurate.
103

Petitioner's failure to take the necessary steps to make
a final diagnosis is a substantial violation of his
obligation to provide care in accordance with
professionally recognized standards of care.

Patient 034026

PRO Findings: Failure to evaluate or follow-up an
abnormal lab value or document etiology of elevated
glucose.

{[I.G.] Analysis: Patient was admitted for renal
colic. A blood sugar of 232 was found on admission.
The Medical records show the elevated blood sugar
determination (232 mg/dL) on 7/24/91 at 1:09. No
further blood sugar determinations are listed in the
laboratory section of the chart. Hospital stay was
from 7/24-26/91. There is no discussion of this in
discharge summary, as there is no discharge summary
in the medical records submitted. Repeat studies
(SMA 18) ordered on 7/26/91; no results in chart.
Practitioner claims subsequent outpatient blood
sugar determinations were normal.

[I.G.}] Decision: The medical records support the
PRO findings, and the findings are upheld. (Quality
of care violation)

My Analysis: This patient was a 75-year old female, who
was admitted to Little Falls Hospital on July 24, 1991
with a diagnosis of renal colic. I.G. Ex. 28 at 8 - 11.
A laboratory test conducted on July 24, 1991 indicated
that the patient had a blood glucose level of 232 mg/dL,
an abnormally high result. I.G. Ex. 28 at 12. The
patient was discharged from the hospital on July 26,
1991. I.G. Ex. 28 at 8. While another blood test was
apparently ordered, the patient's medical record does not
reveal the results of that test. I.G. Ex. 28.

The I.G. did not present any expert testimony as to what
professionally recognized standards of health care would
require in this case. On the other hand, Petitioner
admitted that the result of the follow-up blood test
should have been in the chart. I.G. Ex. 28 at 4;
Petitioner's Brief at 91. Because evidence regarding the
professionally recognized standards of health care is
absent in this case, I have no basis to conclude that
Petitioner's actions in this case represent a quality of
care violation. However, because Petitioner admitted
that the results of the follow-up blood test should have
104

been in the medical record, I conclude that this case
does represent a documentation violation.

This concludes my analysis of the evidence pertaining to
the 13 cases at issue. The totality of the evidence
persuades me that Petitioner engaged in a pattern of acts
or omissions which contravened his obligations under
section 1156(a) of the Act. I find that the cumulative
evidence proves that Petitioner failed in a substantial
number of cases substantially to comply with his
obligations under section 1156(a).

Petitioner argues that there is no basis for an exclusion
in this case because the I.G. has failed to prove that
his treatment of patients has caused harm to them.
However, under section 1156 of the Act, it is not
necessary for the I.G. to prove that Petitioner harmed
his patients. Instead, section 1156 is intended to
protect program beneficiaries and recipients from the
risk of harm by identifying practitioners whose care
fails to meet the standards of practice of their
professions.

The I.G. met her burden of proof by showing that
Petitioner engaged in a pattern of care that is
inappropriate, unnecessary, does not meet professionally
recognized standards of care, or is not supported by the
necessary documentation of care as required by a PRO. 42
C.F.R. § 1004.1(b). Thus, even if I accept as true
Petitioner's assertion that his treatment of patients has
not caused harm, the lack of harm to patients does not
prove that Petitioner has complied with his obligations
under section 1156(a) of the Act.

Petitioner argues that an exclusion is not justified
because he committed "only documentation errors."
Petitioner's Brief at 95. Petitioner admits that his
documentation of the treatment of patients needs
improvement. Tr. 516. Indeed, Little Falls Hospital
physicians who submitted an affidavit in lieu of
testimony on Petitioner's behalf acknowledge that IPRO
had legitimate concerns about Petitioner's documentation
practices. P. Ex. 47 at 3. Thus, while Petitioner
admits that the record shows deficiencies in his
documentation of patient charts, he takes the position
that these documentation deficiencies do not justify an
exclusion.

The excluded practitioner in Corkill v. Shalala, No. Civ-
S-94-669, slip op. at 5 (E.D. Cal. April 14, 1995) made
the same argument. The court rejected the argument,
stating:
105

+ + + even assuming that plaintiff is correct that
in all four cases the Secretary has proved only a
‘documentation’ violation, converting the medical
necessity violations into documentation violations
does not provide plaintiff a basis for overturning
the suspension,

I agree with the court in Corkill. Petitioner is
obligated under section 1156(a) of the Act to document
the quality of his care in a form that is reasonably
required by a reviewing PRO. A showing that Petitioner
engaged in a pattern of acts or omissions which
contravened this obligation proves that he substantially
violated his obligations under section 1156(a) ina
substantial number of cases. Petitioner's attempt to
characterize his violations as mere documentation
deficiencies rather than quality of care violations does
not call into question the ultimate determination that he
failed in a substantial number of cases substantially to
comply with his statutory obligations.

Moreover, I do not agree with Petitioner that the I.G.
proved only documentation deficiencies. While the record
shows that Petitioner violated his obligation to provide
adequate documentation in some instances, it shows that,
in other instances, Petitioner violated his obligation to
provide care of a quality which meets professionally
recognized standards of health care.

I find also that these violations constitute a pattern of
inappropriate treatment. The evidence establishes that
there is some form of violation in 11 of the 13 cases at
issue and that there are multiple violations in many of
those cases. In addition, the violations of statutory
obligations have common features. The evidence
establishes that Petitioner has repeatedly failed to
provide adequate documentation, to order necessary tests,
and to keep pace with accepted treatment modalities.

Petitioner points out that Dr. Sperling testified that
IPRO and its predecessor ESMSEF have been reviewing his
charts since 1988, and he argues that the 13 cases at
issue represent only a small fraction of his total
workload during the period from 1988 through 1991. I
find that Petitioner's assertion that the cases at issue
comprise only a small part of his total practice does not
rebut the evidence of a pattern of substantial violations
which emerges from the 13 cases before me.

c. Petitioner has demonstrated an unwillingness and
lack of ability substantially to comply with the

obligatio: mposed h secti 5 of the
Act.

The I.G. determined that Petitioner has demonstrated an
unwillingness and inability substantially to comply with
the obligations imposed on him by section 1156(a) of the
Act. The I.G. made this determination in accordance with
the Act, which, as a prerequisite to the imposition of an
exclusion against a provider, requires that the Secretary
determine whether that provider has demonstrated an
unwillingness or lack of ability substantially to comply
with his obligation to provide health care as specified
by the Act. Act, section 1156(b) (1).

The Act does not require the I.G. to determine that a
provider is both unwilling and unable substantially to
comply with his obligations under the Act as a
prerequisite to excluding the provider. The Act's
criteria for exclusion are met if the I.G. determines
either that a provider is unable to comply with his
statutory obligations or that a provider is unwilling to
comply with such obligations. In this case, the I.G.
determined that Petitioner has demonstrated both an
unwillingness and an inability substantially to comply
with his obligations. I find that the I.G.'s
determination is supported by the evidence.

The I.G.'s determination is supported by Petitioner's
pattern of inappropriate treatment. Petitioner's
unwillingness and inability to comply with his statutory
obligations is established by his consistent failure to
comply with accepted medical standards in his treatment
of the patients in the cases at issue in this proceeding.
The multiple episodes of Petitioner's failure to obtain
necessary diagnostic tests and his failure to adequately
document his treatment demonstrate his unwillingness and
inability to comply with his statutory obligations.

Moreover, this proceeding did not arise in a vacuum. The
record shows that the violations which are the basis for
this proceeding occurred after Petitioner entered into a
CAP with IPRO's predecessor, ESMSEF, in 1989.
Petitioner's unwillingness and inability to comply with
his statutory obligations is established by his pattern
of substantial violations, coupled with his failure to
rectify his deficiencies, despite having been counseled
to do so by the PRO.

In June of 1989, ESMSEF advised Petitioner that it had
made an initial determination that he had failed to
comply substantially with his obligations under the Act
107

in 14 cases. Petitioner met with ESMSEF in August 1989
to discuss this determination. I.G. Ex. 7, 8.

During that meeting, ESMSEF representatives expounded at
length on the treatment deficiencies they observed. They
criticized Petitioner's documentation of his treatment of
patients. In addition, they criticized Petitioner for
failing to obtain necessary medical tests and
consultations. I.G. Ex. 8. At that time, Petitioner
represented that his documentation practices were
improving. He indicated also that he had begun to obtain
more tests and consultations. I.G. Ex. 8 at 136 - 137.
However, even as he was promising that his medical
practices were changing, he made comments to suggest that
he was making these changes under duress.

With regard to ESMSEF's criticism of his documentation
practices, Petitioner stated that the "more words that
are written, sometimes the more confusion you throw. You
don't know what is going on." I.G. Ex. 8 at 136. With
regard to ESMSEF's criticism of his failure to obtain
medical tests, he stated:

I may have not done all the tests that are proper,
you know. So I am getting defensive now. I get
somebody who comes in with a hopeless stroke, I will
get a CAT scan out of him. I am ashamed of myself,
but I do it. Radiologist thinks I am crazy but I
will do it. See? That is how I am trying to keep
you off my back.

I.G. Ex. 8 at 136 - 137. With regard to obtaining
consultations, Petitioner stated "[sJometimes they are
valuable, sometimes they are not." I.G. Ex. 8 at 137.

These remarks suggest that although Petitioner promised
to change his medical practices in response to criticisms
of ESMSEF, he did not do so willingly. Instead, any
changes he made were made under protest, in order to
prevent ESMSEF from imposing additional sanctions. In
addition, these remarks show that Petitioner was not
persuaded by the reviewing authorities that there were
true deficiencies in the way he practiced medicine.
Petitioner's refusal to acknowledge any deficiencies in
his practice suggests that he may have lacked the ability
to discern what constitutes appropriate care.

In an attempt to rectify the substandard care it
discerned in Petitioner's practices, ESMSEF proposed a
CAP which had three elements: (1) ESMSEF would review
all of Petitioner's hospital admissions for the previous
three month period; (2) Petitioner would take CME courses
108

approved by ESMSEF; and (3) Petitioner would improve the
quality of his documentation. Petitioner agreed to this
CAP. I.G. Ex. 8, 9.

In December 1989, IPRO was awarded the New York State PRO
contract. IPRO assumed the responsibility for monitoring
the implementation of the CAP. Tr. at 25 - 26; I.G. Ex.
10. By letter dated March 29, 1990, IPRO informed
Petitioner that it would review all of Petitioner's
Medicare medical records for a period of three months.

P. Ex. 15. Petitioner agreed also to enter into an
educational intervention program. I.G. Ex. 14 at 3. At
IPRO's request, Petitioner submitted regular reports on
the CME tapes he watched and the CME lectures and
conferences he attended. I.G. Ex. 31.

The reviews and interventions undertaken by the PROs did
not remedy the deficiencies discerned by the PROs. It is
significant that the pattern of quality of care and
documentation violations which I have found in this
proceeding occurred in 1991, after Petitioner entered
into a CAP in 1989. The type of violations which I have
found in this proceeding are similar to the deficiencies
identified by ESMSEF in 1989. Given the resurgence of
similar deficiencies over the years, there is no valid
basis for concluding that Petitioner is willing and able
to comply substantially with his obligations under the
Act.

In this proceeding, Petitioner has again represented that
he is changing his treatment practices in response to the
deficiencies identified by IPRO. However, I am skeptical
of Petitioner's assertions that he is willing and able to
change his treatment practices in view of his continued
refusal to accept wholeheartedly that there are
substantial deficiencies in the way in which he practices
medicine. It is apparent to me, both from Petitioner's
testimony and his demeanor as a witness, that Petitioner
has not fully acknowledged his shortcomings.

During the hearing, Petitioner testified that he
practices "a very good brand of medicine." Tr. at 517.
While he has acknowledged that the documentation in his
charts may have some deficiencies, his testimony suggests
that he believed these deficiencies to be technical
violations which are minor in nature. Petitioner stated
that the reviewing authorities have been "chasing me with
enthusiasm for -- oh, it must be 10 or 12 years." Id.

He expressed the view that the treatment deficiencies
identified by the reviewing authorities are minor and
that they would be found in the charts of any physician
who is exposed to the same level of scrutiny. While
109

Petitioner represented that he is improving his
documentation practices and obtaining more tests and
consultations, he stated that he was doing this because
"I try to protect myself from those people." Tr. at 520.

This testimony shows that Petitioner refuses to fully
accept that his care does not comply with professionally
recognized standards of care. Petitioner's refusal to
accept the deficiencies in his treatment of patients
demonstrates that he is unwilling and unable to comply
with his statutory obligations.

Petitioner argues that he did not receive proper notice
and opportunity to be heard on the issue of whether he
complied with the CAP. This argument is unavailing.

The Act requires that, in deciding whether to exclude a
party, the Secretary (or her delegate, the I.G.) shall
consider a party's willingness or lack of ability to
enter into and successfully complete a CAP. This
provision states:

In determining [whether] a practitioner or person
has demonstrated an unwillingness or lack of ability
substantially to comply with such obligations, the
Secretary shall consider the practitioner's or
person's willingness or lack of ability, during the
period before the organization submits its report
and recommendations, to enter into and successfully
complete a corrective action plan.

Act, section 1156(b)(1). Thus, statutory language
explicitly provides that a provider's willingness and
ability to comply with a CAP is relevant to the I.G.'s
determination of the provider's willingness and ability
to comply with his statutory obligations.

In this case, the I.G. fulfilled this statutory
obligation. In the Notice, the I.G. notified Petitioner
that, in making the determination that Petitioner is
unwilling and unable to comply with his obligations, the
I.G. considered Petitioner's failure to improve his
practice pattern even after he entered into the CAP in
1989. Notice at 7. Petitioner was notified that this
was an issue in this proceeding and he had an opportunity
to be heard on it in this forum. Moreover, IPRO informed
Petitioner in its sanction notices and other
correspondence that Petitioner had not rectified his
treatment deficiencies in spite of the 1989 CAP. I.G.
Ex. 14 at 1, 4, I.G. Ex. 15 at 13, I.G. Ex. 1. Based on
the foregoing, I find that Petitioner has not shown that
110

his notice and hearing rights were abridged at any stage
of the sanction process.

Petitioner argues also that he complied with the 1989
CAP. He asserts that he met the requisite CME
requirements and that he improved his medical treatment
practices. Petitioner's Response at 20.

CAPs are proposed by a PRO when the PRO discerns a
pattern of substandard care. The purpose of a CAP is to
rectify a provider's deficiencies so that he can render
care that meets professional standards. In this case,
Petitioner was to take CME courses as part of the CAP.
The record shows that he cooperated in meeting the CME
requirements imposed by the PRO. However, the fact that
Petitioner took the requisite CME courses did not prevent
him from continuing to render substandard care. In
addition, Petitioner's assertion that he improved his
treatment practices is not persuasive in light of
Petitioner's pattern of violations of his obligations
after he entered into the 1989 CAP. Petitioner's failure
to rectify his deficiencies after he agreed to a CAP is
convincing evidence that he is unwilling and unable to
comply with his statutory obligations.

I conclude that the I.G. proved by a preponderance of the
evidence that authority exists to exclude Petitioner. I
find that the evidence in this case strongly supports
IPRO's recommendations, as adopted by the I.G., that
Petitioner engaged in a pattern of substantially
inappropriate treatment of his patients, in violation of
his obligations under section 1156(a) of the Act. In
addition, the evidence supports the I.G.'s conclusion
that Petitioner has demonstrated an unwillingness and
lack of ability to substantially comply with his
obligations.

II. Petitioner's five-year exclusion is reasonable,
comports with the remedial purposes of the Act and is
supported by the evidence.

Petitioner argues in his briefs that the I.G. has failed
to meet her burden of proof and, consequently, the
statutory bases for the exclusion have not been met. I
have already addressed those arguments in this decision
and have found them without merit. Therefore, having
concluded that the I.G. has met the statutory
requirements for an exclusion of Petitioner, the
remaining issue before me is whether the proposed
exclusion is reasonable and comports with the remedial
purposes of the Act. For the reasons cited below, I

111

conclude that the record before me amply supports the
proposed five-year exclusion.

Particularly troubling to me is the fact that the conduct
which formed the basis of IPRO's recommendation to the
I.G. arose after Petitioner had agreed to a CAP imposed
by ESMSEF in 1989 in response to earlier alleged
substantial violations of Petitioner's obligations under
section 1156 of the Act. The conduct challenged in this
case arose from a focused review of Petitioner's hospital
admissions over the course of several months in 1991.
Moreover, Petitioner, as part of the CAP, agreed to
enroll in a CME program designed to remedy the conduct
previously found not to meet professionally recognized
standards of care. In addition, Petitioner agreed to
improve the quality of his documentation of the treatment
provided to hospitalized patients, including the basis
for a patient's admission to a hospital and a description
of Petitioner's treatment of such patient. The practices
Petitioner engaged in which IPRO and the I.G. challenged
in this case are, for the most part, very similar to the
practices Petitioner engaged in which led to the CAP;
e.g, failure to order appropriate tests and to adequately
document in hospital records his treatment of patients.
Therefore, serious questions exist as to whether
Petitioner can ever conform his conduct to that mandated
by professionally recognized standards of care.

Equally disturbing is Petitioner's explanation that he
disliked engaging in "defensive medicine" which may cause
some discomfort to his patients. Tr. at 348 - 349. As
shown by this record, Petitioner's refusal to have a
number of his patients undergo appropriate diagnostic
tests placed these patients at risk of exposure to
undiagnosed diseases with attendant possible serious
consequences. See, for example, discussions related to
patients 031409, 031943, and 060460. The mandatory CME
courses Petitioner was required to take had little effect
on his practice of medicine. Moreover, such practice of
medicine occurred after his prior treatment of patients
was subject to close scrutiny by IPRO, with an
understanding that continuation of the challenged conduct
would result in a recommendation by IPRO that he be
112

excluded.” Despite the threat of an exclusion,
Petitioner did not alter his conduct.

At the hearing, Petitioner attempted to counter the
findings of IPRO with the testimony of his expert, Dr.
Nicholas. While in some cases Dr. Nicholas did raise
some legitimate issues, at other times he offered
damaging testimony that Petitioner's treatment failed to
meet the professionally recognized standards of care.

In addition, in some instances, Dr. Nicholas raised
medical issues that Petitioner did not consider at the
time of treatment. See, for example, the discussions
relating to patients 031409 and 060460. Such obvious
post hoc rationalizations fail to offset the credible
evidence offered by the I.G. that Petitioner failed to
meet professionally recognized standards of care in the
treatment of such patients.

Petitioner has asserted inadequate documentation as a
response on more than one occasion when IPRO has
criticized the quality of his care. See, for example,
the discussions relating to patients 031943, 030053, and
037680. Considering Petitioner's pattern of failure to
have his patients undergo requisite diagnostic testing
and the absence in the record of written or telephonic
orders for nursing staff that is consistent with
Petitioner's version of his treatment of such patients, I
find Petitioner's reliance on documentation lapses to
explain his conduct to be unpersuasive and lacking in
credibility. There is no basis for me to believe that
Petitioner provided more appropriate care than that which
he documented in his patients' records.

Petitioner still fails to fully understand the
significance of his conduct. Even if I accept that
Petitioner will be more careful in documenting his
treatment of patients in the future, I am not convinced
that such documentation will alter his treatment
decisions. In short, his treatment of patients will
arguably continue to be below professionally recognized
standards of care with regard to diagnostic decisions
concerning choices of treatment, even if such decisions

9 While there is no specific admission by
Petitioner to this effect in the record, I conclude from
the vigor with which he defended his conduct throughout
the lengthy sanction process by the various New York
State PRO's that he was aware of the possibility that an
exclusion could be recommended as a result of the PROs'
investigations.
113

are better documented. This would result in his future
treatment of program beneficiaries and recipients being
at an unacceptable level.

I am mindful that Petitioner has practiced general
medicine in Little Falls, New York, for approximately
fifty years. This is a laudable accomplishment
considering the general lack of medical providers in non-
metropolitan areas. I am cognizant that the Little Falls
Hospital, where Petitioner admitted the patients at
issue, is a relatively small hospital which does not have
access to the latest equipment or to the level of
expertise that might be found at a teaching hospital in a
major metropolitan area. But as Dr. Nicholas testified,
even with the understanding that the practice of medicine
may be different at a teaching hospital, certain of
Petitioner's practices are still below professionally
recognized standards of care. See, for example, the
discussion related to patient 037680. Unfortunately,
Petitioner's failures to have his patients undergo
appropriate diagnostic tests, and the resulting choice of
treatment, may have prevented his patients from going to
other hospitals where they could have received care that
met professionally recognized standards. Petitioner
exposed such patients to the possible unnecessary risk of
illnesses for which they were not properly diagnosed or
treated. Similarly, Petitioner's documentation failures
could lead to confusion in the future treatment of his
patients when the current treatment is not clearly set
forth in the patient records. Although the record
contains no evidence of any direct connection between
Petitioners's conduct and the onset of an undiagnosed or
untreated illness or problems with subsequent treatment
of his patients, the possibility that such occurrences
could result is sufficient to warrant an exclusion in his
case.

The I.G. proposes a five-year exclusion. There is
nothing in this record to support a finding that the
five-year exclusion is either extreme or excessive. I
base this on the extensive history that Petitioner has
had with the State of New York PROs, including the
intensive review of his hospital treatment records over a
period of several months in 1991, the unwillingness and
inability of Petitioner to understand the gravity and
significance of his conduct, and his reliance on post hoc
rationalizations to justify or excuse his conduct. I am
hopeful that the imposition of the exclusion will cause
Petitioner to more seriously examine his treatment
procedures and practices, so that at the end of the five-
year exclusion he will qualify to be reinstated as a
program provider. The record reflects that Petitioner is
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motivated by the belief that he is acting in the best
interests of his patients. I am hopeful that, once
Petitioner accepts that such conduct is not in their best
interest, he will be similarly motivated to conform his
practices with professionally recognized standards of
care, and thereby provide a basis for his participation
as a program provider.

III. Petitioner poses a serious risk to patients.

A provider who is the subject of an exclusion
determination made pursuant to section 1156 is entitled
to a de novo hearing before an administrative law judge
on the issues of whether the exclusion is authorized
under law and whether the length of the exclusion is
reasonable. Ordinarily, the I.G. may effectuate an
exclusion determination made pursuant to section 1156
prior to any administrative hearing. Thus, while the
hearing is de novo, the exclusion ordinarily is in effect
prior to the hearing on the merits of the case.

The exception to this procedure is in the case of a
provider whose practice is located in a rural health
professional shortage area or in a county with a
population of less than 70,000. The Act provides that,
in such a case, before any exclusion may be imposed, the
excluded provider is entitled to a hearing and a ruling
as to whether he or she poses a serious risk to patients.

In this case, by letter dated May 3, 1994, the I.G.
notified Petitioner that he was excluded pursuant to the
authority under section 1156 of the Act. Petitioner
requested a hearing. By letter dated August 31, 1994,
the I.G. informed Petitioner that she had determined that
the population of the county in which Petitioner
practices medicine is less than 70,000. The I.G.
informed Petitioner that, before an exclusion could be
effected, Petitioner was entitled to a hearing on the
issue of whether he posed a serious risk to patients.
Based on this, the I.G. informed Petitioner that the I.G.
was reinstating Petitioner's eligibility to be reimbursed
for items and services provided to program patients.

In order to avoid the duplication and delays which would
result from two hearings, the parties requested that I
consolidate the hearing on the issue of serious risk and
the hearing on the authority to exclude and the
reasonableness of the length of the exclusion. They also
requested that posthearing briefs consolidate arguments
on all of these issues. I granted the parties' request,
and this decision consolidates the issues of serious
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risk, the authority to exclude, and the reasonableness of
the length of the exclusion.

Although there may be some question as to the necessity
of the serious risk finding at this stage of the
proceeding, the issue is not completely clear as to
whether the exclusion will take effect should Petitioner
appeal my decision to uphold the five-year exclusion. It
is my understanding that the intent of the statute is
that the exclusion should take effect after a decision on
the merits that is adverse to a provider. However, as
there have been no rulings on this issue, I have decided
to address the serious risk issue here.

The Act does not define the term "serious risk."
However, it has been interpreted in prior rulings as a
propensity to unreasonably expose a patient to a hazard
or danger of serious harm. fe) Ww. innocentes ,
Ruling on Serious Risk, at 5 (April 20, 1992). To prove
serious risk, it is not necessary that the 1.G. prove
repeated episodes of patient endangerment. Exposure of a
patient to a grave hazard in any one case, or to less
grave but serious errors occurring with enough frequency
to place patients in danger of serious harm, is
sufficient.

I find that the evidence offered by the I.G. supports the
conclusion that Petitioner poses a serious risk to
patients. This finding is based on the pattern of

care which I have found in Petitioner's treatment of his
patients. Petitioner's treatment of patients
demonstrates both a lack of judgment and of knowledge of
appropriate basic medical responses in the evaluation and
care of patients.

My conclusion that Petitioner is a serious risk is not
based on findings that Petitioner actually harmed his
patients. This conclusion is based on my finding that
Petitioner's treatment practices exhibit serious
deficiencies. I am concerned about the overall
substandard quality of care shown by Petitioner.

The evidence adduced by the I.G. establishes that
Petitioner failed repeatedly to obtain basic diagnostic
information. Petitioner's care of several patients
displayed significant gaps in his understanding of the
tests which were needed to adequately evaluate a medical
condition. Petitioner's failure to obtain necessary
diagnostic information exposed his patients to
unacceptable risk of harm in several cases.
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For example, in the case of. patient 031943, Petitioner's
failure to obtain an endoscopy or an upper GI series
before selecting treatment for a patient with an upper GI
bleed exposed the patient to the serious risk of having
the cause of her bleed go undetected and untreated. This
exposed the patient to the risk of a recurrence of the
bleeding. In addition, the severity of the error was
amplified by the fact that this patient had a family
history of stomach cancer.

Another example of an unacceptable risk caused by
Petitioner's treatment is found in his care of patient
039837. The testimony related to this patient
established that an x-ray should have been taken
immediately after a thoracentesis was performed, in order
to determine whether the procedure was done properly and
that it did not damage the patient's lung. Petitioner's
failure to take an x-ray immediately after this procedure
exposed the patient to the risk of serious complications
affecting her ability to breathe.

The evidence establishes a pattern of Petitioner's
failure to follow appropriate medical practices to
evaluate patients. It establishes also a pattern of
inadequate documentation of medical care. I infer from
the pattern of practice which the I.G. proved that the
acts and omissions engaged in by Petitioner are
representative of Petitioner's ongoing practice and are
not isolated instances.

I recognize that Petitioner has asserted that he does not
pose a serious risk to patients because he now practices
medicine in a way that responds to the concerns
identified by the I.G.'s experts. It is possible that
Petitioner may have made some changes to his medical
practice. However, it is apparent to me that Petitioner
still does not appreciate the seriousness of his
deficiencies in the way he practices medicine. For that
reason, Petitioner's self-serving averments that he has
conformed his medical practice to meet the 1.G.'s
concerns are not persuasive.

CONCLUSION

I conclude that the I.G. has the authority to impose and
direct an exclusion against Petitioner pursuant to
section 1156(b)(1) of the Act. In addition, the five-
year exclusion which the I.G. imposed and directed is
reasonable. I conclude also that Petitioner is a serious
risk to patients within the meaning of section 1156 of
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the Act. Accordingly, this exclusion is to go into
effect 20 days after the date of this decision.

/s/

Edward D. Steinman
Administrative Law Judge