STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 00-1263

) JEFFREY CHESTER ALLARD, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in this case on August 29, 2000, at Miami, Florida, before Claude B. Arrington, a duly-designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Kim M. Kluck, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Marc P. Ganz, Esquire

McGrane & Nosich, P.A.

2801 Ponce de Leon Boulevard Twelfth Floor

Coral Gables, Florida 33134 STATEMENT OF THE ISSUES

Whether Respondent, a medical doctor, violated Section 458.331(1)(m), Florida Statutes, as alleged in Count I of the

Administrative Complaint and, if so, the penalty or penalties that should be imposed.

Whether Respondent violated Section 458.331(1)(t), Florida Statutes, as alleged in Count II of the Administrative Complaint, and, if so, the penalty or penalties that should be

imposed.

PRELIMINARY STATEMENT

On December 23, 1999, Petitioner filed an Administrative Complaint against Respondent that contained certain factual allegations as to his interpretation and subsequent report following a bilateral mammogram in 1995 for a patient who will be referred to by her initials, P. D. Based on those allegations, Petitioner charged in Count I that Respondent violated the provisions of Section 458.331(1)(m), Florida Statutes, and, in Count II, that Respondent violated the provisions of Section 458.331(1)(t), Florida Statutes.

Respondent timely requested a formal hearing, the matter was referred to the Division of Administrative Hearings, and this proceeding followed.

At the formal hearing, the parties presented two joint exhibits (marked as J1 and J2, respectively), both of which were accepted into evidence. In addition, Petitioner presented portions of Respondent's deposition taken in an underlying proceeding (the redacted deposition was submitted as

Petitioner's Exhibit 1), and the testimony of Dr. Adam Fueredi, M.D., via video deposition (the transcript of that deposition was admitted as Petitioner's Exhibit 4, and the video of that deposition was admitted as Petitioner's Exhibit 5).

Petitioner's Exhibits 1, 4, and 5 were admitted into evidence.

1/

Respondent testified on his own behalf and presented the

additional testimony of Dr. Michael Joseph Foley, M.D. Respondent presented seven sequentially numbered exhibits, each of which was accepted into evidence.

A transcript of the proceedings was filed on November 6, 2000. Petitioner and Respondent filed proposed recommended orders, which have been duly-considered by the undersigned in the preparation of this Recommended Order.

FINDINGS OF FACT

1. Effective July 1, 1997, Petitioner is the agency of the State of Florida charged with regulating the practice of medicine pursuant to Section 20.34, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Pursuant to the provisions of Section 20.43(3), Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide investigative and prosecutorial services required by the Division of Medical Assurance, councils, or boards, as appropriate.

2. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0053773.

3. Respondent has been board-certified in radiology since 1989.

4. In 1995, at the time of the screening mammogram at issue in this proceeding, Respondent was a radiologist at Fisherman's Hospital in the Florida Keys.

5. At the times pertinent to this proceeding, Respondent and Fisherman's Hospital used a classification system to describe the results of mammograms. That classification, developed by the American College of Radiology in 1992, is referred to as BI-RADS, which is an acronym for Breast Imaging Reporting and Data System. The following six categories are used:

   Category 0: Need Additional Imaging Evaluation: Finding for which additional imaging evaluation is needed. This is almost always used in a screening situation and should rarely be used after a full imaging work up. A recommendation for additional imaging evaluation includes the use of spot compression, magnification, special mammography views, ultrasound, etc.

   
   

   Category 1: Negative: There is nothing to comment on. The breasts are symmetrical and no masses, architectural disturbances or suspicious calcifications are present.

   
   

   Category 2: Benign Finding: This is also a negative mammogram but the interpreter may

   wish to describe a finding. The interpreter might wish to describe findings while still concluding that there is no mammography evidence of malignancy.

   
   

   Category 3: Probably Benign Finding - Short Interval Follow-Up Suggested: A finding placed in this category should have a very high probability of being benign. It is not expected to change over the follow-up interval, but the radiologist would prefer to establish its stability. Data are becoming available that shed light on the efficacy of short interval follow-up.

   
   

   Category 4: Suspicious Abnormality - Biopsy Should Be Considered: There are lesions that do not have the characteristic morphologies of breast cancer, but have a definite probability of being malignant.

   The radiologist has sufficient concern to urge a biopsy.

   
   

   Category 5: Highly Suggestive of Malignancy - Appropriate Action Should Be taken: These lesions have a high probability of being cancer.

   
   

6. On August 10, 1994, Dr. Sheldon Kushner referred his patient, P. D., to Fisherman's Hospital for a routine screening mammogram. The mammogram was interpreted by Dr. Wayne Moccia, a radiologist. Dr. Moccia's report reflected a dense fibroglandular pattern and scattered microcalcifications in both breasts. No masses or densities were identified. Dr. Moccia recommended a follow-up mammogram in six months for comparison if no prior mammogram was available.

7. On July 21, 1995, Dr. Kushner referred P. D. to Fisherman's Hospital for a follow-up screening mammogram.

   Respondent was the radiologist who directed the taking of the mammogram views and subsequently interpreted them. Respondent performed two standard screening mammogram views for each breast

   - the cranial caudial view and the medial lateral oblique view. There is no allegation that these views were inappropriate.

8. Respondent compared the results of the July 1995 mammogram to the results of the August 1994 mammogram and thereafter prepared a report, dated July 21, 1995. 2/

9. Respondent's report reflects that routine bilateral mammogram views were taken of the patient. The following reflects Respondent's findings:

   Comparison is from 8-10-94. There are several small clusters of calcifications, particularly in the left breast. The overall breast parenchymal density is increased, as before. No discrete mass. No change in the morphology of the calcifications.

   
   

10. Under the part of the report marked "Conclusion", the following appears:

    1. Stable calcifications. As some of these are indeterminate in morphology, I would recommend a bilateral follow-up in one additional year to ensure continued stability. (Category 3).

       
       

11. The reference to Category 3 is to the BI-RADS classification.

12. According to Dr. Kushner's records, which were admitted into evidence without objection, P. D. was examined by

    Dr. Kushner on July 27, 1995. Dr. Kushner found P. D.'s breast examination to be within normal limits.

13. P. D. returned to Fisherman's Hospital for a screening mammogram on August 14, 1996. At that time, Dr. Moccia compared the mammogram view taken on that date with the mammogram views taken August 1994 and July 1995. Dr. Moccia detected abnormalities which led him to conclude that there was a strong suspicion for malignancy of P. D.'s left breast. Dr. Moccia classified the 1996 mammogram as a Category 5 and recommended a biopsy. It was subsequently determined that P. D. had cancer in her left breast.

14. There was a conflict in the evidence as to whether Respondent's interpretation of P. D.'s 1995 mammogram fell below the standard of care. Dr. Fueredi, Petitioner's expert, testified that Respondent's interpretation was below the standard of care and explained his reasons for his opinions. Dr. Foley, Respondent's expert, testified that Respondent's interpretation did not fall below the standard of care and explained his reasons for his opinions. Both of these experts are found to be highly qualified, and the testimony of each

    expert on this issue is found to be credible. There is no basis to credit Dr. Fueredi's testimony over that of Dr. Foley, or vice-versa. Petitioner failed to prove by clear and convincing evidence that Respondent failed to meet the standard of care in

    classifying P. D.'s July 1995 mammograms as BI-RADS Category 3. Petitioner also failed to establish by clear and convincing evidence that Respondent should have ordered immediate further testing for P. D.

15. BI-RADS Category 3 suggests a short interval follow- up, without defining what constitutes a short interval. Again there was a conflict in the evidence as to whether Respondent's recommendation that P. D. be re-examined in a year fell below the standard of care. Dr. Fueredi testified that the interval for recommended follow-up should have been four to six months, and that Respondent's recommendation for a one-year follow-up fell below the standard of care. Dr. Foley testified that it was acceptable for Respondent to recommend the one-year follow- up. Both of these experts gave lengthy explanations for their opinions.

16. Respondent's testimony as to this issue was conflicting. In his deposition testimony, Respondent testified that he intended to classify the mammogram as Category 3 BI- RADS, which meant to him that there should be a six-month follow-up. In his deposition, Respondent also testified that a recommendation for a one-year follow-up was inconsistent with a Category 3 classification. At the final hearing, Respondent testified that he was confused in his deposition, and that he intended to recommend a one-year follow-up because he knew that

    Dr. Kushner usually ordered mammograms for patients in P. D.'s age group every two years. This self-serving testimony given by Respondent at the final hearing lacks credibility and is rejected. Dr. Foley and Respondent (at the final hearing) did not convincingly explain how a normal follow-up interval for

    P. D. could also be appropriately considered to be an appropriate short interval follow-up within the meaning of BI- RADS Category 3. Respondent's deposition testimony that a recommendation for a one-year follow-up is inconsistent with a Category 3 classification is much more persuasive than his testimony on that issue at the final hearing.

17. In resolving the conflicting testimony on this issue, the undersigned has concluded that Respondent's report contains an inconsistency which creates confusion as to the appropriate follow-up interval. The report fails to clearly reflect Respondent's examination results and recommendations for P. D.

    CONCLUSIONS OF LAW

    
    

18. The Division of Administrative Hearings has jurisdiction of the parties to and the subject of this proceeding. Section 120.57(1), Florida Statutes.

19. Petitioner has the burden of proving by clear and convincing evidence the allegations against Respondent. See Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987); Evans Packing

    Co. v. Department of Agriculture and Consumer Services, 550

    So. 2d 112 (Fla. 1st DCA 1989); and Inquiry Concerning a Judge,

    
    

    645 So. 2d 398 (Fla. 1994). The following statement has been repeatedly cited in discussions of the clear and convincing evidence standard:

    Clear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the evidence must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of fact the firm belief of [sic] conviction, without hesitancy, as to the truth of the allegations sought to be established. Slomowitz v. Walker, 429

    So. 2d 797, 800 (Fla. 4th DCA 1983).

    
    

20. Section 458.331(1), Florida Statutes, provides, in pertinent part, the following grounds for discipline of medical doctors:

    (m) Failing to keep . . . medical records that . . . justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.

    
    

    * * *

    
    

    (t) Gross or repeated malpractice or the failure 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. . . .

21. Petitioner failed to prove by clear and convincing evidence that Respondent practiced below the standard of care in his interpretation and classification of P. D.'s mammogram in July 1995. Respondent should be found not guilty of violating the provisions of Section 458.331(1)(t), Florida Statutes, as alleged in Count II of the Administrative Complaint.

22. Petitioner proved by clear and convincing evidence that Respondent's report fails to accurately reflect his recommendation as to the appropriate interval for P. D.'s follow-up mammogram. Respondent should be found guilty of violating the provisions of Section 458.331(1)(m), Florida

    Statutes, as alleged in Count I of the Administrative Complaint.

    
    

23. Pertinent disciplinary guidelines are found at Rule 59R-8.001, Florida Administrative Code. The following recommended penalty for the violation of Section 458.331(1)(m), Florida Statutes, is consistent with those guidelines and with the provisions of Section 458.331(2), Florida Statutes.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order adopting the findings and conclusions contained in this Recommended Order. For the violation of Section 458.331(1)(m), Florida Statutes, it is recommended that Respondent be assessed an administrative fine in the amount of $500.00.

DONE AND ENTERED this 14th day of November, 2000, in

Tallahassee, Leon County, Florida.

CLAUDE B. ARRINGTON

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 14th day of November, 2000.

ENDNOTES

1/ Petitioner's Exhibits were pre-marked. Petitioner's pre- marked Exhibits 2 and 3 became unnecessary because of the two joint exhibits.

2/ Petitioner asserts that Respondent signed his report in blank and that he did not review the report after it was transcribed. Respondent testified that he signed reports in blank on occasion, but he did not know whether he signed P. D.'s report in blank. In the absence of any other evidence supporting Petitioner's allegation that Respondent signed P. D.'s report in blank, it is concluded that Respondent's testimony is insufficient to establish, by clear and convincing evidence, that he did so.

COPIES FURNISHED:

Marc P. Ganz, Esquire McGrane & Nosich, P.A.

2801 Ponce de Leon Boulevard Twelfth Floor

Coral Gables, Florida 33134

Kim M. Kluck, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

Tanya Williams, Executive Director Board of Medicine

Department of Health 4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

William W. Large, General Counsel Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

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.

Docket for Case No: 00-001263

Orders for Case No: 00-001263