STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )

)

Petitioner, )

)

vs. )

)

MOHAMMAD QAZI, M.D., )

)

Respondent. )

Case No. 01-2484PL

)

RECOMMENDED ORDER

A formal hearing was held in the above-styled cause before Daniel M. Kilbride, Administrative Law Judge, the Division of Administrative Hearings, on November 14, 2001, in Orlando, Florida.

APPEARANCES

For Petitioner: Ephraim D. Livingston, Esquire

Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229

For Respondent: Mary Gannon McMurry, Esquire

Rissman, Weisberg, Barrett, Hurt, Donahue & McLain, P.A.

201 East Pine Street, 15th Floor Orlando, Florida 32802

STATEMENT OF THE ISSUES

Whether Respondent's license as a physician should be disciplined for alleged violations of Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with the level

of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, as set forth in the Administrative Complaint.

PRELIMINARY STATEMENT

An Administrative Complaint filed by the Department of Health on May 15, 2001, charged Respondent, Mohammad Quazi, M.D., with violating Section 458.331(1)(t), Florida Statutes. Respondent timely executed his Election of Rights form, requesting a formal hearing pursuant to Sections 120.569 and 120.57(1), Florida Statutes. On June 26, 2001, this matter was referred to the Division of Administrative Hearings for a formal hearing and discovery followed. Following two continuances granted at the request of the parties, the formal hearing was held on November 14, 2001.

The above-cited Administrative Complaint alleges that Respondent violated Section 458.331(1)(t), Florida Statutes, 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 one or more of the following ways:

1. Respondent failed to examine previous mammogram studies, for Patient M. L., even though she had a history of previous breast cancer with mastectomy.

2. Respondent failed to recommend further studies in 1996 when a new 5 x 6 mm density showed on the films, which include but are not limited to a sonogram, tissue biopsy and or short-term follow-up mammogram in six months to assess for change.

3. Respondent failed to note change in size of nodule, from 5 mm to approximately 8 mm, on the June 23, 1997 mammogram.

4. Respondent failed to adequately assess Patient M. L.'s symptoms on two occasions. Any unusual or new finding may be a symptom and the new nodule on may 8, 1996 received inadequate further assessment; also, the lack of a precise measurement of the nodule on June 23, 1997, constitutes an inadequate radiologic assessment.

At the formal hearing, Petitioner presented the testimony of one expert witness: Michael Estner, M.D. (hereinafter

Dr. Estner). Petitioner introduced three exhibits, which were entered into evidence. Respondent presented the testimony of two witnesses: Respondent's Expert, Michael Foley, M.D. (hereinafter Dr. Foley), and Respondent, who testified in his own behalf. Respondent introduced ten exhibits, which were entered into evidence.

A Transcript was prepared and filed on December 28, 2001.

Following a motion to extend the time for submitting post- hearing submittals, each party submitted their proposed recommended orders on January 18, 2002. Each party's proposals have been given careful consideration in the preparation of this Recommended Order.

FINDINGS OF FACT

1. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapter 456, Florida Statutes, and Chapter 458, Florida Statutes.

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 0056502, and currently practices with Florida Radiology Associates, Altamonte Springs, Florida.

3. Respondent is Board certified in Diagnostic Radiology and Nuclear Medicine.

4. A mammogram is an examination constructed with a dedicated x-ray device, and dedicated x-ray film and dedicated holders for the film. The breast of a person is placed between a compression plate and a holder. The breast tissue is compressed to provide a maximum exposure of the breast tissue. A x-ray beam is shined through the breast tissue and the image is recorded on x-ray film. A mammogram is generally done in two projections craniocaudal (CC view) and medio lateral oblique (MLO view). The CC view is performed with a vertical beam. The x-ray is shot straight up and down and the breast tissue is compressed in a horizontal fashion. The MLO view is performed in a similar fashion, side to side.

5. Mammography is a screening tool to identify breast cancer. A screening mammogram is performed annually. A diagnostic mammogram is generally done at a shorter time period, whether within three months or six months post identified new density.

6. The base line mammogram should be performed between the ages of thirty-five and forty. Serial mammography continues for the rest of the life of the patient. Serial mammography is utilized to assess the patient for change or stability. Stability is preferable, change is indicative of an adverse process.

7. A radiologist will examine the studies; if there are prior studies the radiologist compares the previous studies with the current studies and render an opinion as to the appearance of the tissues on the mammograms in question. The radiologist examines the studies on special view boxes that are constructed to optimize in the visualization of the mammogram. The radiologist during the examination of the studies, attempts to screen background and ambient light from distracting the reading of the mammogram.

8. A density is a structure visible in only one view or dimension. A nodule is having a three dimensional characteristic visible in multiple orthogonal projections.

9. The fundamental nature of a nodule can not be assessed through mammographic characteristics. A radiologist describes a nodule by its borders, whether they are smooth, well circumscribed or speculated, and whether or not there are calcifications or distortion of adjacent tissues. The fundamental nature of a nodule includes the composition of the structure.

10. A sonogram is a simple mechanism, which can be used to identify the cystic or solid nature of a nodule. A cystic nodule is fluid filled and generally relates to a benign process. However, when a nodule is characterized as solid this indicates that the nodule is filled with cells that are suspicious for malignancy.

11. A radiologist when describing the position of a nodule subdivides the breast in quadrants such as upper, outer, lower and inner and describes the positions as they correlate to a clock face, if someone is looking straight on at the breast tissue. The nipple is considered the center of the clock.

12. The radiologist generates a report concerning the interpretation of the studies. This includes a description of the tissue, assessment of its findings and a recommendation for follow-up.

13. The standard of care for a newly identified nodule is to assess the mammographic characteristics, its composition, its

    relative density on film, its margination, the presence or absence of calcifications, and the involvement or apparent involvement of adjacent tissues. Prior to making a determination that a lesion is benign, observing simple clear, well-circumscribed mammographic borders is not sufficient to make that level of determination.

14. On or about May 25, 1995, Patient M. L., a 50-year-old female with a history of a prior left mastectomy, presented to Florida Hospital-Kissimmee for the performance of a unilateral mammogram. Patient M. L. had a series of prior mammograms at the Orlando Regional Medical Center on February 11, 1989, November 14, 1991, July 24, 1992, April 12, 1993, and April 11, 1994. She also presented on May 8, 1996 and June 23, 1997. Also, on May 15, 1996, Patient M. L. underwent spot compression views. On each occasion, Patient M. L.'s films were interpreted by Respondent.

15. Respondent first became involved in Patient M. L.'s care on May 25, 1995, at Florida Hospital. Respondent interpreted Patient M. L.'s May 25, 1995, mammogram to be within normal limits. The evidence in this matter, including that presented by Petitioner, establishes that Respondent's interpretation of that mammogram was accurate. On May 25, 1995, Respondent was unable to compare Patient M. L.'s mammogram to her previous mammogram studies, as those studies had been

    obtained at a different hospital. It is undisputed that, since the May 25, 1995, mammogram was normal, the standard of care did not require Respondent to obtain the prior studies for comparison.

16. Respondent met the standard of care in his interpretation of the mammogram of May 25, 1995. The standard of care did not require Respondent to review Petitioner M. L.'s prior mammograms, which were located at a facility other than Florida Hospital.

17. On May 8, 1996, May 15, 1996, and June 23, 1997,

Respondent did review the prior mammogram films which were available and his actions in that regard met the standard of care.

1. On May 8, 1996, Patient M. L. returned to Florida Hospital to undergo a repeat mammogram. On that date, Respondent identified a new 5 x 6 mm, well circumscribed, benign-appearing, density in the right breast. Respondent's characterization of the mammographic finding is not in dispute. The margins of the density at issue on the May 8, 1996 mammogram were well circumscribed. Well circumscribed margins are consistent with a benign density.

2. Petitioner's contention that the standard of care required Respondent to order a short-term follow-up mammogram on May 8, 1996, is without merit. Petitioner's own expert could

   only state that the standard of care "might" include a recommendation for short-term mammographic follow-up. Without question, testimony that the standard of care "might" include a recommendation for short-term mammographic follow-up does not meet the requirement that Petitioner establish its allegations by clear and convincing evidence.

3. The complaint contends that, on May 8, 1996, Respondent deviated from the standard of care when he did not order a sonogram. Again, Petitioner has failed to sustain its burden of proving that such a study was required. First, the density which had been identified had only benign characteristics. Second, the density was only 5 x 6 mm in size, which would have made it difficult to locate and analyze with sonography. Petitioner's expert conceded that there are multiple benign solid entities which may occur in a woman's breast, such as lymph nodes, fibroadenomas and papillomas, which do not warrant the performance of a sonogram. He never clearly explained the rationale for stating that a sonogram should have been performed on this density, which demonstrated multiple benign characteristics, including lucency, a hallmark characteristic of benign lymph nodes. Dr. Estner admitted that, even if a sonogram had been completed, it would not have provided any information about whether the density in Patient

   M. L.'s breast was benign or malignant. Rather, it merely would have revealed whether the density was cystic or solid.

4. The complaint further contends that, on May 8, 1996, Respondent deviated from the standard of care when he did not order a biopsy. Petitioner's own expert conceded that a biopsy was probably not warranted.

5. On May 15, 1996, upon recommendation by Respondent, Patient M. L. returned to Florida Hospital to undergo spot compression views to further evaluate the density which had been identified on the May 8, 1996, mammogram. Respondent concluded that the compression views demonstrated a benign-appearing density in the right breast, which was most likely a lymph node. Again, Petitioner's own expert agreed that the compression views demonstrated a benign appearing density.

6. Patient M. L.'s mammogram of June 23, 1997, did not reveal a radiographically significant change from the May 8, 1996 mammogram. Respondent did not conduct an inadequate radiologic assessment. Respondent sufficiently characterized the density identified in the June 23, 1997 mammogram in his radiology report. The standard of care did not require Respondent's report of the June 23, 1997 mammogram to contain a precise measurement of the density.

7. The standard of care did not require Respondent to order additional studies as a result of the June 23, 1997,

   mammogram. In particular, the standard of care did not require Respondent to order a sonogram or tissue biopsy. Further, the standard of care did not require Respondent to order a short- term follow-up mammogram as a result of the June 23, 1997, mammogram.

8. Petitioner has also failed to present competent evidence that Respondent's interpretation of the June 23, 1997, mammogram and his recommendations related thereto were in violation of the standard of care. Petitioner's expert could not recall whether he had ever reviewed both the MLO and CC views which comprised the June 23, 1997, mammographic study. Dr. Estner's testimony that sonography should have been performed after the June 23, 1997, mammogram was in direct contradiction to his other testimony which indicated that aggressive identification of the composition or histology of the cells of a lesion, through biopsy or sonography, would only be warranted if there was enlargement or some other change in the appearance of the lesion from one year to the next. Dr. Estner had conceded at one point in his testimony that the lesion may have been stable. Further, there was no indication by

   Dr. Estner that there was any other change in the appearance of the lesion between May 8, 1996 and June 23, 1997. Dr. Estner also rendered conflicting testimony about whether there was any change in the density between the May 8, 1996 and June 23, 1997

   films. At one point he suggested that there had been only a "minor change," yet at another point, as noted above, he stated "that the lesion has at least been stable."

9. Even Dr. Estner's suggestion that the density may have exhibited a "minor change" between May 8, 1996, and June 23, 1997, would not support a recommendation for sonography. "Minor change" would not support a recommendation for sonography because Dr. Estner acknowledged that is possible for a lesion to appear to have changed dimension from one year to the next on a mammogram but remain the same in its actual size. Such changes can be related to the distance of the lesion from the film in the mammographic apparatus from year to year, the orientation of the breast in the machine, and the degree of compression applied.

10. Dr. Qazi and Dr. Foley both re-iterated that sonography was unwarranted after the June 23, 1997, mammogram because the density had not changed and it continued to exhibit benign characteristics. Petitioner's complaint suggests that Respondent should have ordered short-term mammographic follow-up on June 23, 1997. Yet, Dr. Estner merely characterized

    short-term mammographic follow-up as "an option" and "possible." He did not indicate that such follow-up was mandated by the standard of care. Neither Dr. Qazi nor Dr. Foley believed that short term follow-up was necessary. Short-term follow-up was

    unnecessary not only because the density had benign characteristics, but also because it had remained unchanged over a period of one year since the previous mammogram.

11. Respondent presented convincing evidence that the cancer which was diagnosed on May 19, 1998, was not the same density which Respondent had described in the May 8, 1996 and June 23, 1997, films. Dr. Estner, who, again, had failed to read both views which comprised the June 23, 1997, mammogram, conceded on direct examination that "it's conceivable that the lesion that we have identified at this time is, in fact, new, and maybe in a different part of the breast from the nodule we were following."

12. The testimony of Petitioner's expert, Michael Estner, M.D., is not persuasive as it is imprecise and not explicit. Dr. Estner did not review the original mammograms which are at issue in this case. The copies of the mammogram films that he did review were degraded and incomplete. In addition, copies of mammogram films can cause certain areas to appear more enhanced and more abnormal than on the original films. Dr. Estner did not know whether the copies he had reviewed in this action had caused the alleged area of abnormality to appear more pronounced. As a result, Dr. Estner's opinions can not be considered precise or explicit and they clearly do not meet the standard set forth for clear and convincing evidence.

13. The opinions expressed by Respondent and Respondent's expert, Michael Foley, M.D., are credible and persuasive.

14. Respondent did not violate Florida Statute Section 458.331(1)(t). Specifically, Respondent's care of Patient M. L. did not constitute 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.

    CONCLUSIONS OF LAW

    
    

15. The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of this proceeding, pursuant to Sections 120.569 and 120.57(1), Florida Statutes, and Section 456.073, Florida Statutes.

16. Pursuant to Section 458.331(2), Florida Statutes, the Board of Medicine is empowered to revoke, suspend or otherwise discipline the license of a physician for the following violations of Section 458.331(1)(t), Florida Statutes:

    (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. . . .

17. When the board finds any person guilty of any of the grounds set forth in subsection (1), it may enter an order imposing one or more of the following penalties:

    1. Refusal to certify, or certification with restrictions, to the department an application for licensure, certification, or registration.

    2. Revocation or suspension of a license.

    3. Restriction of practice.

    4. Imposition of an administrative fine no to exceed $5,000 for each count or separate offense.

    5. Issuance of a reprimand.

    6. Placement of the physician on probation for such a period of time and subject to such conditions as the board may specify, including, but not limited to, requiring the physician to submit to treatment, to attend continuing education courses, to submit to reexamination, or to work under the supervision of another physician.

    7. Corrective action.

       
       

       Rule 61F6-20.001(1), Florida Administrative Code.

       
       

18. License disciplinary proceedings are penal in nature.

    
    

    State ex rel, Vining v. Florida Real Estate Commission, 281 So. 2d 487 (Fla. 1973). In this disciplinary proceeding, Petitioner must prove the alleged violations of Section 458.331(1)(t), Florida Statutes, by clear and convincing evidence. Department of Banking and Finance, Division of Securities and Investor Protection v. Osborne, Stern & Co., 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987); See Addington v. Texas, 441 U.S. 426 (1979).

19. The definition of "clear and convincing" evidence is adopted from Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983), which provides:

    [C]lear 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 testimony 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 a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.

    
    

    See also Smith v. Department of Health and Rehabilitative

    
    

    Services, 522 So. 2d 956 (Fla. 1st DCA 1988).

    
    

20. Petitioner has failed to establish by clear and convincing evidence that Respondent violated Section 458.331(1)(t), Florida Statutes, by 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, as alleged in the Administrative Complaint.

RECOMMENDATION

Based on the foregoing, it is

RECOMMENDED that the Board of Medicine issue a final order finding that Respondent did not violate Section 458.331(1)(t), Florida Statutes, and the Administrative Complaint be dismissed.

DONE AND ENTERED this 31st day of January, 2002, in Tallahassee, Leon County, Florida.

DANIEL M. KILBRIDE

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 31st day of January, 2002.

COPIES FURNISHED:

Ephraim D. Livingston, Esquire

Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229

Mary Gannon McMurry, Esquire

Rissman, Weisberg, Barrett, Hurt, Donahue & McLain, P.A.

201 East Pine Street, 15th Floor Orlando, Florida 32802

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: 01-002484PL

Orders for Case No: 01-002484PL