vs. ) Case No. 00-1025
ALAN T. BRAUNSTEIN, M.D., )
Respondent. )
A hearing was held in this case in Tampa, Florida, on January 10, 2001, before Arnold H. Pollock, an Administrative Law Judge with the Division of Administrative Hearings.
For Petitioner: Ephraim D. Livingston, Esquire
John E. Terrel, Esquire Agency for Health Care
For Respondent: William B. Taylor, IV, Esquire
The issue for consideration in this hearing is whether Respondent's license as a physician in Florida should be
disciplined because of the matters alleged in the Administrative Complaint filed herein.
By Administrative complaint dated June 8, 1999, Petitioner herein, Board of Medicine (Board), charged Respondent, Dr. Alan T. Braunstein, with failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances in his treatment of patient, B. O., from August 8, 1994, to May 24, 1995, in violation of Subsection 458.331(1)(t), Florida Statutes. On June 25, 1999, Respondent requested a formal hearing on the allegations, and this hearing ensued.
Dr. John M. Harvey, a Board-certified specialist and an expert in internal medicine; and Dr. Mitchel J. Seleznick, a professor and precept in internal medicine at the University of South Florida Medical School and a practitioner in that field. Petitioner also introduced Petitioner's Exhibits 1 through 5. Respondent testified in his own behalf and introduced Respondent's Exhibits A through F.
A Transcript of the proceeding was furnished on January 22, 2001. Subsequent to the receipt thereof, counsel for both
parties submitted matters in writing which were carefully considered in the preparation of this Recommended Order.
At all times pertinent to the issues herein, Petitioner, Board of Medicine, was the state agency responsible for the licensing of physicians and the regulation of the medical profession in Florida. Respondent was licensed as a physician in Florida, holding medical license ME0024661. Respondent is certified in internal medicine.
From December 28, 1993, through August 2, 1994, B. O. was the patient of Dr. Martin Marks, during which time the patient was administered several PSA (Protein Specific Antigen) tests at Dr. Marks' order. The first was done on December 28, 1993, and showed a level of 16.6.
A PSA test is a blood screening test used in conjunction with a digital rectal examination to detect cancer of the prostate. A PSA test is not, by itself, indicative of the presence or absence of prostate cancer. It is used as a screening tool to help the physician determine whether a patient should be evaluated further for prostate cancer. A digital rectal exam is an exam in which the physician palpates the patient's prostate to determine its size and whether it has an abnormal texture or contains nodules. The digital rectal exam, used in conjunction with the PSA test, ultrasound
examination, and biopsy, can determine the presence of prostate cancer.
Not all abnormalities of the prostate gland are cancerous. Prostatitis is a non-cancerous inflammation and/or infection of the prostate gland. It is can cause an elevated PSA level and also is diagnosed through the use of a digital rectal exam and urinalysis. Under the state of practice existing in 1994/1995, the physician would "milk" the prostate. This involved applying pressure to the prostate during a digital rectal exam to force the prostate to secrete a discharge which is then excreted from the body in urine and detected and evaluated in a urine test.
The normal range for a PSA test is from 0 to 4.0.
During the period that Dr. Marks was treating B. O., the patient's PSA test result was, as stated previously, 16.6 on December 28, 1993. Later tests showed a level of 13.2 in January 1994, 7.9 in February 1994, 9.5 in March 1994, and 9.5 in May 1994. During this period, B. O. was treated with an antibiotic for a prostate infection, and, as is seen, his PSA rate declined from 16.6 to 7.9, rising again to 9.5. However, a PSA reading of 7.9 is still almost twice that considered at the top of the maximum range.
Respondent first saw B. O. for an insect bite on August 8, 1994. A PSA reading taken on that date showed a
level of 10. At that time, B. O. was fifty-seven years old. Proper medical practice provides that a male over fifty years of age, with an elevated PSA reading, normally should receive further evaluation to rule out cancer of the prostate.
Respondent noted on the patient's record that date, "show Dr. Marks." Dr. Marks subsequently annotated the record with his own comment on the lab form, reading, "stable."
The standard of care in the medical community at that time called for an abnormal PSA result with either additional tests in the office or referral of the patient to a urologist for further evaluation. Respondent did neither. Petitioner's expert claims that when Respondent took over treatment of the patient, who was presenting with an elevated PSA result, he should have at least performed a digital rectal examination or should have referred the patient to a urologist. However, Respondent was aware of the previous higher PSA readings which had been responsive to the administration of antibiotic therapy, and he was satisfied the patient suffered from an infection of the prostate, not cancer. As a result, he did no more on August 8, 1994, than order the patient to have another PSA test, which showed a level of 10, and set up another appointment for the patient with Dr. Marks for three months later. B. O. did not keep the appointment with Dr. Marks.
Respondent saw B. O. next again on February 15, 1995, for a complaint unrelated to the patient's elevated PSA reading. Respondent did not do a digital rectal examination of the patient at that time. He only ordered another PSA test to be taken and made an entry in the patient's medical record to make a referral to a urologist if the PSA results were higher. The results of the PSA test taken on February 15, 1995, showed a level of 14.6. Clearly, and consistent with Respondent's entry in B. O.'s record on February 15, 1995, B.
O. should have been referred to a urologist immediately.
Respondent admits this. However, because B. O. refused a referral, none was made.
B. O. saw Respondent on May 2, 1995, and asked for a referral to a orthopedic specialist for a broken hand and fever. Respondent evaluated the hand and also evaluated B. O.'s prostate condition, but did not order a PSA test at that time. Respondent scheduled an appointment with B. O. for May 22, 1995, and on that date, ordered a PSA test. When the result showed a reading of 28.8, Respondent referred the patient to a urologist who diagnosed cancer of the prostate.
B. O.'s cancer was treated with a combination of hormonal and radiation therapy.
Petitioner's expert, Dr. John M. Harvey, Board- certified in internal medicine and pulmonary diseases,
reviewed B. O.'s patient records kept by Drs. Marks and Braunstein. Based on his review, he concluded that Respondent's treatment of B. O. fell below standard because Respondent did not do a digital examination of the patient, even after being made aware of the elevated PSA level; did not document prostatitis in the patient's records; and did not refer the patient to a urologist when the PSA level did not stabilize. In 1994, as now, it is the standard of care in the medical community that any abnormal PSA level should be followed up and should consist of a digital rectal examination and evaluation by another physician or referral to a urologist.
Here, in the opinion of Dr. Harvey, a proper follow- up was not done. Albeit a repeated PSA was done, the prostate was not examined. If, as apparent, Respondent chose not to do a digital examination of the patient, he should have referred the patient to another physician who would do it.
Dr. Harvey also rejected Respondent's thesis that he believed B. O. was suffering from prostatitis. Treatment of this condition is by antibiotic over a 4 to 6-week course, which was done here. Dr. Harvey has no quarrel with Respondent's treatment of the prostatitis. However, when the condition continued to exist for 9 months, as appears to have been the case here, the physician should have begun to wonder
if something else was going on, and Dr. Harvey is convinced that Respondent should have done other diagnostic procedures.
Dr. Harvey admits that the SOAP standard for medical records existing in 1994 was met by Respondent. SOAP stands for Subjective (what the patient relates), Objective (the results of examinations and tests), Analysis, and a Plan for treatment. The records show that a diagnosis was made and a referral to a urologist considered but not done, initially. Only after the PSA levels continued to elevate was a referral made, and a digital examination first done. It is Dr. Harvey's opinion that a digital rectal examination should have been done and a referral to a urologist made earlier on. Respondent cannot, in Dr. Harvey's opinion, rely on the patient's refusal to accept a referral. Under the standard in effect in 1994, when B. O. failed to return and refused to accept a referral, Respondent should have documented the refusal in the patient's record, which he failed to do.
Dr. Harvey also contends that "watchful waiting," as
appears to have been done here by Respondent, does not rule out the use of a digital rectal examination. If the PSA is elevated, and a digital rectal exam is normal, the physician can be more comfortable with "watchful waiting." However, it would not be prudent to fail to do anything more than the PSA. Dr. Harvey admits he did not know that Dr. Marks had done a
digital rectal examination of B. O. prior to the December 28, 1994, PSA reading and had conferred with Respondent about it. It is his opinion, however, because of the length of time that had elapsed, he would have repeated the examination even if the initial diagnosis was prostatitis. Also, even though the large drop in the PSA level would tend to indicate prostatitis, Harvey would wonder why the level remained so far above normal. In that regard, prostatitis generally takes between four and nine weeks to cure. Respondent's expert, however, admits that if the condition is chronic, it may take as much as nine months to cure.
There is a substantial body of medical authority which argues against the efficacy of the PSA test, contending that the cost of the test is not supported by the diagnostic value. However, when the test has been done and it gives an abnormal reading, it is not appropriate to disregard it. Under the circumstances of the instant situation, a referral to a urologist was appropriate as early as February 15, 1995, when Respondent first suggested it. That suggestion was not followed up, however.
Dr. Mitchel Seleznick, a Board-certified internal medicine specialist on the staff of the University of South Florida Medical School, testifying for Respondent, related that the PSA test was developed because the success of the
digital rectal examination as a screen for prostate cancer was so poor. Medical opinion was that the PSA, coupled with an ultrasound examination was better. The Public Health Service uttered its call for cancer screening as a preventive measure, but the results, according to Dr. Seleznick, showed a measurable decrease only in women.
Dr. Seleznick contends that to date there is no showing at all that the death rate from prostate cancer can be reduced by the PSA screen. Although Medicare now pays for PSA tests, up until approximately one year ago it did not because the test was not considered significant enough to justify the expense. Dr. Seleznick considers the PSA test to be so unreliable, he does not use it. This is somewhat consistent with the testimony of Dr. Harvey that the PSA test is not determinative. If done, however, the results should be considered.
The physicians who testified at hearing both contend that the PSA test will not, by itself, establish the presence of cancer. However, the medical evidence presented establishes clearly that the PSA test is a beacon of abnormality and, as such, should not be ignored. Clearly, early identification of cancer of the prostate, through whatever means, and aggressive treatment must have a reductive impact on the mortality rate.
Dr. Seleznick opined that Respondent did what was appropriate for B. O. in his treatment of the patient. He recognized the PSA evaluation. He repeated it to verify the initial findings. He referred the patient to a urologist for treatment, and Dr. Seleznick believes that both the referral and the timing of the referral were appropriate. Three months is not, in his opinion, unreasonable. The patient was successfully treated by the urologist and is currently cancer- free. Because a digital rectal examination previously had been done by Dr. Marks, Respondent did not have to repeat it. Dr. Seleznick considers the digital rectal examination to be notoriously unreliable. Further, Dr. Seleznick contends that a reasonable physician would not require a patient to undergo a biopsy, with its attendant risks, without its being absolutely necessary, and, considering the circumstances of this case known to Respondent at the time, he does not consider it to have been necessary.
Dr. Braunstein justifies his failure to perform a
digital rectal examination on August 8, 1994, on several grounds. Respondent knew another PSA test was to be done and he knew that the digital rectal exam could have an effect on the reading. The patient had come in for an insect bite, not with a complaint related to the prostate. Respondent discussed the patient with Dr. Marks and knew that Dr. Marks
would follow up after the PSA test was done. In fact, Dr. Marks did follow up and wrote "stable" on the lab result.
When B. O. saw Respondent on February 15, 1995, he was complaining of severe indigestion and did not mention any uro-genital or prostate-related problems. On that visit, Respondent queried B. O. as to why he had not come back as requested. He also discussed the PSA level with the patient and suggested a referral to a urologist. The patient declined a referral at that time, even though Respondent indicated that if the PSA level came back higher, he would make the referral anyway. When the PSA test came back the next day showing a reading of 14.6, Respondent determined a referral to a urologist was appropriate, but before the referral could be made, B. O.'s chart was taken from Respondent's desk, and Respondent then forgot to make the referral.
It was only when B. O. came back on May 2, 1995, with the injury to his hand that Respondent remembered the referral. He immediately wrote out the referral to Dr. Acosta for May 24, 1995. On May 22, 1995, Respondent ordered another PSA test which revealed a level of 28.8. This report was immediately forwarded by fax to Dr. Acosta. B. O.'s prostate condition was managed by Dr. Acosta from that point on.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of this proceeding. Subsection 120.57(1), Florida Statutes.
In its Administrative Complaint, the Board of Medicine has alleged that Respondent was guilty of substandard performance in the practice of medicine in violation of Subsection 458.331(1)(t), Florida Statutes, by failing timely to refer patient B. O. to a urologist for further evaluation of elevated PSA test results and by failing to perform additional testing, such as a digital rectal examination on the patient.
Subsection 458.331(2), Florida Statutes, authorizes the Board of Medicine to discipline a licensed physician for a violation of Subsection 458.331(1)(t), Florida Statutes, by:
[F]ailure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. . . .
Petitioner has the burden to establish that Respondent committed the violation alleged by clear and convincing evidence. Department of Banking and Finance v. Osborne Stern and Company, 670 So. 2d 932 (Fla. 1996).
The evidence of record establishes that Respondent first saw the patient, B. O., on August 8, 1994. Prior to
that time, the patient had been seen by another physician in the clinic who had ordered several PSA tests be run. All these tests showed elevated PSA levels ranging from a high of
16.6 to a low of 7.5 with a reading of 9.5 the last reading before Respondent assumed treatment responsibility for the patient. A review of the patient's medical record reflected that Dr. Marks was treating him with antibiotics after a diagnosis of prostatitis. A PSA test done on August 8, 1994, showed a level of 10. A normal PSA level for a man over 50, the patient's age, is 4 or less.
Respondent followed the patient over a period of months, satisfied in his own mind that Dr. Marks' diagnosis of prostatitis was correct. Even when the patient's PSA level began to rise again, he consulted with Dr. Marks who was of the opinion the patient's condition was stable and entered a notation to that effect in the records. At no time did Respondent administer a digital rectal examination of the patient or refer the patient to a urologist for further evaluation. He chose to monitor the patient's condition and set up an appointment for the patient after three months, which the patient did not keep. Only when the PSA level continued to rise, shown in a PSA test done on February 15, 1995, did Respondent suggest a referral to the patient who initially refused. Respondent should have referred the
patient anyway. He claims he made a note to do so, but the patient's file was misplaced before that could be done, and the matter slipped him mind. This is a serious omission.
When Respondent saw the patient on May 15, 1995, for an unrelated matter, he made the referral which should have been made earlier and also ordered a PSA test be done. The results of this test, received on May 22, 1995, showed a level of 28.8.
Both the expert testifying for the Board and the expert testifying for Respondent agree that the PSA test alone is not a positive indication of cancer of the prostate. By the same token, both agree that a digital rectal examination is not a positive indicator either. However, an elevated PSA is an indication of an abnormality of the prostate, though that abnormality may be prostatitis, not cancer. While a digital rectal examination done in conjunction with an elevated PSA level is not a positive indicator of cancer, the feel of the prostate glad that the physician gets from a digital exam gives some indication of a problem or the lack thereof. A positive diagnosis of cancer can be made only through ultrasound and biopsy of the suspected portion of the prostate gland.
An elevated PSA and an abnormal feel to the prostate gland may still be consistent with prostatitis. Dr.
Seleznick, Respondent's expert, indicated that in light of the prior diagnosed prostatitis and the reduction in PSA levels after administration of antibiotics, a result consistent with chronic prostatitis; it was not below standards for Respondent to wait as much as three months for the prostatitis to clear up before referring the patient to a urologist. The Board's expert, while recognizing that neither the PSA nor the digital rectal exam are positive indicators, contends they are clear signals that something is wrong and Respondent should have looked further. This is the better position. It is clear that under the circumstances of this case the failure to take a position beyond "watchful waiting" from August 1994 to May 1995, during which time the patient's PSA levels never dropped below twice normal, constitutes a failure to practice medicine with that level of care, skill, and treatment which is recognized as being acceptable under similar conditions and circumstances. See Subsection 458.331(10), Florida Statutes.
Respondent sought to admit into evidence a copy of
the deposition of Dr. Randy Kahn, a radiological oncologist who was deposed in a collateral matter involving the patient and this Respondent. Dr. Kahn is in practice in Brandon, Florida, less than 100 miles from this hearing. Respondent urges the admission of this deposition as a deposition of an expert witness in an earlier action involving the same
parties. Here, however, the Board of Medicine was not a party to the patient's suit against Respondent. Therefore, Petitioner's objection is sustained and the deposition of Dr. Kahn is excluded.
Petitioner suggests as an appropriate penalty in this case the imposition of an administrative fine of $5,000, the imposition of a reprimand, and the requirement for Respondent to perform 20 hours of continuing medical education in the area of risk management or prevention and internal medicine.
Disciplinary guidelines of the Board of Medicine promulgated in Rule 64B8-001, Florida Administrative Code, provide for a range of penalties for a violation of the provisions of Subsection 458.331(1), Florida Statutes. A proven violation of Subsection 458.331(1)(t), Florida Statutes, authorizes a penalty ranging from probation for two years to revocation of the license and an administrative fine of from $250 to $5,000.
By way of aggravation, Petitioner has introduced a final order of the Board of Medicine in a prior case involving Respondent. This action, resulting from a plea of guilty to two felony narcotics possession charges, was not considered by the undersigned in any way prior to the determination of guilt of the allegation in the instant case. However, the prior
action can be and is here considered in the assessment of penalty for the instant violation.
Assessment of a maximum administrative fine does not appear to be an appropriate penalty in this case where the patient was not shown to have been subject to unnecessary expense by Respondent's actions. However, it is clear that Respondent should have impressed upon him the requirement to pay proper attention to the need for providing medical care within existing standards.
Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order finding Respondent guilty of practicing medicine in a manner blow professional standards, placing Respondent on probation for two years under such terms and conditions as prescribed by the Board, and imposing an administrative fine of $1,000.
___________________________________ ARNOLD H. POLLOCK
Ephraim D. Livingston, Esquire John E. Terrel, Esquire
William B. Taylor, IV, Esquire Macfarlane, Ferguson & McMullen Post Office Box 1531
Theodore M. Henderson, Agency Clerk Department of Health
William W. Large, General Counsel Department of Health
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
