STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF MEDICAL ) EXAMINERS, )

)

Petitioner, )

)

vs. ) CASE NO. 86-4887

)

RAUL ROMAGUERA, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the above matter was heard before the Division of Administrative Hearings by its duly designated Hearing Officer, Donald R. Alexander, on March 24 and 25, 1987 in West Palm Beach, Florida.

APPEARANCES

For Petitioner: Stephanie A. Daniel, Esquire

130 North Monroe Street Tallahassee, Florida 32399-0750

For Respondent: Charles C. Powers, Esquire

Michael S. Smith, Esquire Post Office Box 15021

West Palm Beach, Florida 33409 BACKGROUND

By amended administrative complaint filed on February 24, 1987, petitioner, Department of Professional Regulation, Board of Medicine, has charged that respondent, Raul Romaguera, a licensed physician, had violated Subsection 458.331(1)(t), Florida Statutes (Supp. 1986). 1/ The underlying allegations supporting the complaint are that in December, 1980, respondent, who is a pathologist, incorrectly diagnosed the specimen removed from a patient's thigh as being lipoma. When the lipoma recurred some four years later, it is alleged two other pathologists reviewed the original patient slides in January, 1985 and concluded respondent had incorrectly diagnosed the specimen, and that the patient actually had a well differentiated myxoid liposarcoma (cancer).

According to the amended complaint, respondent's conduct constituted 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 as proscribed in Subsection 458.331(1)(t), Florida Statutes (Supp. 1986).

Respondent disputed the above allegations and requested a formal hearing pursuant to Subsection 120.57(1), Florida Statutes (Supp. 1986). The matter was referred by petitioner to the Division of Administrative Hearings on December

16, 1986, with a request that a hearing officer be assigned to conduct a formal hearing. By notice of hearing dated January 16, 1987, the final hearing was scheduled on March 24 and 25, 1987, in West Palm Beach, Florida.

Respondent's motion to dismiss the complaint for failure to state a cause of action was denied by order of the undersigned dated March 16, 1987.

At final hearing petitioner presented the testimony of Dr. Nat Stephens, vice-president of medical administration at Doctor's Hospital of Lake Worth (DHLW), Dr. Joseph Pilkington, a pathologist at DHLW, Jane Skinner, a secretary in the DHLW pathology department, Donna Scott, a DHLW histologist, Christie J. Dietert, a DPR investigator, Dr. James A. Benz, an expert in surgical and clinical pathology, Dr. Arthur F. Bickel, assistant county medical examiner, and Dr. Charles Matuszak, an orthopedic surgeon. Petitioner also offered petitioner's exhibits 1-33. All were received in evidence. Exhibits 2, 3, 4, and 30-33 are the depositions of Dr. Louis S. McCann, Jr., Dr. Raymond Hackett, Carol Heape, respondent, Dr. Kirby I. Bland, Dr. Watson Kime, and Dr. Marc Wallack, respectively. It is noted that only a portion of the McCann deposition was admitted into evidence. After petitioner rested, respondent moved to dismiss the complaint because of petitioner's alleged failure to make a finding of probable cause. This was denied as being untimely. Respondent testified on his own behalf and presented the testimony of Dr. Stephen I. Hajdu, the senior attending pathologist at Memorial Sloan Kettering Cancer Center in New York City. Respondent also offered respondent's exhibits 1-4 which were received into evidence.

The transcripts of hearing (three volumes) were filed on April 20, 1987.

Proposed findings of fact and conclusions of law were filed by respondent on May 5, 1987. None were filed by petitioner. A ruling on each proposed finding of fact is made in the appendix attached to this Recommended Order.

At issue is whether respondent's license as a medical doctor should be disciplined for the alleged violations set forth in the amended administrative complaint.

Based upon all of the evidence, the following findings of fact are determined:

FINDINGS OF FACT

1. Introduction

   
   

   1. At all times relevant hereto, respondent, Raul Romaguera, held physician license number ME 0010347 issued by petitioner, Department of Professional Regulation, Board of Medical Examiners (DPR). Romaguera has been licensed by the State since 1962. He now resides at 7810 South Flagler Drive, West Palm Beach, Florida. The initiation of this proceeding represents the first occasion on which he has been the subject of disciplinary action.

      
      

   2. Respondent is a graduate of Havana University where he received a degree in medicine in 1952. At that time, a medical degree required the completion of a seven year program. Between 1955 and 1962, Romaguera completed five years of residency in pathology at three hospitals in Tennessee and Florida. In 1962 he successfully completed the examination for licensure in Florida, and began working as a pathologist at a hospital in Boynton Beach. In 1973 respondent and certain other physicians founded Doctors' Hospital of Lake Worth, Inc. (DHLW). The hospital was eventually sold to Hospital Corporation of

      America in 1980. However, Romaguera has continued working as a pathologist at the facility. He is a board certified pathologist, having passed the board examinations in 1962. When the events herein occurred in 1979 and 1980, Romaguera was chief of the pathology department and director of the pathology laboratory at DHLW. In addition to supervising department and laboratory personnel, Romaguera also actively performed pathology services.

      
      

2. The Discipline of Pathology and Its Use

   
   

   1. Pathology is a branch of medicine which studies diseases. This involves the clinical diagnosis of disease through the examination of tissues and organs by various laboratory methods.

      
      

   2. The discipline of pathology comes into play when tissue specimens are removed from a patient's body by a surgeon and then sent by the requesting physician to a pathologist for examination. This tissue is more commonly referred to as the gross specimen. Upon receipt at the laboratory, a histologist assigns it a number, records it in a book, and then refers it to the pathologist for the initial or gross examination. The pathologist examines the specimen, describes it for his records, and then cuts several small sections from the gross specimen. After the gross examination is completed, the sections are processed in formal in to dehydrate the tissue cells and make them firm. They are then injected with hot paraffin wax. The next morning the histologist prepares a "paraffin block" and places the blocks into a machine (microtome) where microscopic slides are cut. Thereafter, the sections are placed in a water bath to remove the paraffin and the tissue is then placed on glass slides. These slides are given to the pathologist for microscopic scrutiny. After reviewing them, the pathologist prepares a report, signs it, and returns the same to the requesting physician.

      
      

   3. In 1979 and 1980, Romaguera's department was handling between 6,000 and 7,000 cases per year. At that time, there were no more than four or five full and part-time pathologists in the department. Under then-existing DHLW procedures, the requesting physician filled out a form to be sent with the specimen. The form contained the patient's name, age, sex, hospital identification number (if any), clinical impression, radiological findings (if any), and the size and location of the lesion. If any other pertinent clinical information was known, it was the surgeon's responsibility to convey this to the pathologist. However, unless something out of the ordinary was present, no other communication between the pathologist and requesting physician took place.

      
      

3. Lipoma or Liposarcoma?

   
   

   1. There are two types of soft-tissue tumors: lipoma and liposarcoma.

      The distinction between a lipoma and liposarcoma is not insignificant. A lipoma is a benign tumor while a liposarcoma is a malignant or cancerous growth. If a liposarcoma is diagnosed as being well-differentiated, it has a low malignant potential and is not growing rapidly. In this case, the controversy lies over a soft tissue tumor of a patient examined by respondent in 1980, and whether it was a lipoma or a well-differentiated myxoid liposarcoma.

      
      

   2. In September, 1980 a patient by the name of R.C. visited the offices of Dr. Nat Stephens, then a West Palm Beach family practitioner. R.C., a 42 year old male, was complaining of a lump which had formed just above his right knee.

      R.C. related to Stephens that the mass had formed some two years earlier, and had grown in size over that period of time. By September, 1980 it measured around 20x10cm, or 4"x8" by more commonly known measurements, had a feeling of

      "soft, fatty mass," and had a tumorous shape. Dr. Stephens' original impression was that the mass was a lipoma. Nonetheless, he promptly referred R.C. to Dr.

      Charles Matuszak, a local surgeon, with a recommendation that the tumor be excised and then examined by a pathologist.

      
      

   3. Dr. Matuszak is a board certified orthopedic surgeon. He admitted R.C. to DHLW on September 21, 1980. After admission, Matuszak had a right femoral arteriogram performed on R.C. on September 23. The radiologist made the following impression:

      
      

      There is an avascular soft tissue mass which does not show any evidence for malignant vessels or neoplastic change, radiographically.

      
      

      Additional X-rays revealed no erosion of the bone, and produced normal readings. It is noted West Palm Beach had no CT scan in 1980.

      
      

   4. R.C. was discharged on September 24 with a final diagnosis of "probable lipoma, pending pathology report." He was scheduled for elective surgery within the next few months to remove the mass.

      
      

   5. On December 7, 1980 R.C. was readmitted to DHLW for surgery. This was performed the next day. Matuszak described the surgery as "routine" and "a fairly straight forward procedure." He was able to "shell out" most of the mass although one part of the tumor had adhered to the periosteum over the right distal femur and required tying off a vessel. However, this was not unusual since even a benign tumor can adhere to the bone. The size of the mass was described in the hospital records as being 15x17cm. R.C. was later discharged on December 13.

      
      

   6. Although a surgeon can excise tissue from the patient, freeze it, and send it to pathology for immediate evaluation before the wound is closed, Matuszak elected not to do so since he did not suspect the tumor was malignant based on his own evaluation and a corresponding finding in the radiology report. Matuszak's final diagnosis was "lipoma of right thigh."

      
      

   7. A specimen of the tissue was forwarded by Matuszak to DHLW on December

      8 with a request that an examination be made. The request contained R.C.'s name, age, admission number to hospital, room number, doctor and the following clinical impressions:

      
      

      Nature of specimen and clinical data: SOFT TISSUE

      MASS, RIGHT THIGH

      
      

      Pre-op Dx: Soft tissue mass, right thigh Post-op Dx: pending pathology

      This was the normal amount of information provided to a pathologist by a requesting physician.

      
      

   8. Romaguera does not specifically recall the R.C. specimen since he has handled thousands of specimens since that time. However, through the use of R.C.'s records, he again concluded there was nothing unusual about the request, or anything that required further consultation with Matuszak. In fact, neither Matuszak or respondent recall conferring about the case. When R.C.'s specimen arrived at the laboratory, respondent first made a gross inspection of the R.C.

      specimen along with 25 or 30 others, and then forwarded them to the histology section for entry into the log book. Records indicate the R.C. specimen was logged in on December 8, 1980, given surgical pathology number 2980, and assigned to respondent for examination.

      
      

   9. According to the pathology report, Romaguera's gross examination revealed the following:

      
      

      The specimen consists of an encapsulated tumoral mass measuring 11cm in diameter. The capsule is composed of thin transparent and translucent membrane. The tumor on sections shows a multilobulated fat undergoing focal degeneration.

      
      

      In other words, Romaguera observed a fatty tissue with a degeneration of the fat in certain areas. That is, some areas were "softer" than others, and had different colors. These were typical characteristics of a lipoma. Although there is no record of the number of sections made, Romaguera believes there were two or three.

      
      

   10. After the sections were processed that evening, the next morning Romaguera performed his microscopic examination of the specimen and concluded as follows in his report:

       
       

       Sections are of adipose tissue undergoing in certain places myxomatous degeneration and also exhibiting fibrous septation. Focal fresh hemorrhage is also seen. The tumor is encapsulated by fibrocollageneous tissue.

       
       

       The "focal fresh hemorrhage" was caused by the surgery and was not unusual. The fibrous septation was not indicative of malignancy while the mucoid like substances that were observed were not dispositive of a cancerous tumor.

       Romaguera accordingly reached a final diagnosis of "lipoma, right thigh."

       
       

   11. The pathology report was returned to Matuszak on December 9 with a lipoma diagnosis. Matuszak informed R.C. of these findings but told him there was a chance of recurrence even though the tumor was benign. After discharge,

       R.C. returned to Matuszak's office for several follow-up visits and was discharged in May, 1981. Had a diagnosis of malignancy been received, Matuszak would have referred R.C. to Shands Teaching Hospital and Clinics in Gainesville, Florida, a facility which specializes in the treatment of tumors.

       
       

   12. On November 27, 1984 R.C. returned to Matuszak's office with a recurrence of swelling and pain in his right thigh. A CT scan was ordered which revealed a well-encapsulated soft tissue mass anterior to the distal femur. Matuszak diagnosed this as a probable recurrent lipoma and admitted R.C. to DHLW on January 7, 1985. After a pathology report revealed the tumor was a low-grade malignancy, Matuszak referred R.C. to Shands for further treatment.

       
       

   13. At Matuszak's request, the DHLW pathology department was requested to review R.C.'s 1980 slides to determine if the original diagnosis was correct. This review resulted in different findings by other pathologists. Armed with this information, R.C. filed a malpractice suit against respondent, the first in respondent's career, and also turned the matter over to DPR. The agency's administrative complaint was thereafter issued which prompted this proceeding.

4. The Experts' Opinions

1. To determine if Romaguera's examination in 1980 was right or wrong, and whether his examination conformed with then prevailing standards, a number of experts were assembled by both sides to again review the slides in question. For DPR, they included an assistant medical examiner for Palm Beach County (Dr. Benz) who last did surgical pathology in the early 1970s, but who reviewed literature to become reacquainted with the specialty, a Boynton Beach board certified pathologist (Dr. Bickel) who once worked for respondent in 1974, and the video deposition testimony of a Daytona Beach board certified pathologist (Dr. McCann) who worked at DHLW from 1982 until October, 1986. Finally, depositions of three physicians who testified for R.C. in his malpractice suit against respondent were offered. In addition to his own testimony, Romaguera offered the testimony of the senior attending pathologist in surgical pathology and the chief of the cyto pathology department at Memorial Sloan Kettering Cancer Center in New York City (Dr. Hajdu). Of the four to five thousand soft tissue sarcomas diagnosed each year in the United States, around twenty five to thirty percent are referred to Hajdu's facility for consultation. Also having particular significance is Hajdu's membership on the American Joint Committee, a three person committee which sets the criteria to be used by pathologists throughout the nation in making evaluations such as the one being questioned.

   He has been a member of that committee for fifteen years. Finally, Hajdu is also a full professor at Cornell University Medical College.

   
   

2. According to Dr. Benz, who is now a county medical examiner and specializes in forensic pathology, R.C.'s slides indicated immature fat cells, an increased number of blood vessels and areas of degeneration, all being characteristics that are indicative of a liposarcoma. In addition, the location of the tumor was a "favorite" place for a liposarcoma to occur. Benz conceded a soft tissue diagnosis is "extremely difficult" to make, but opined that the immature cells, richer vascular configuration and degeneration should have alerted respondent to suspect a malignancy and to obtain additional sections for examination and to obtain a second opinion. Although Benz has not been active in this area since the early 1970s, and had to review textbooks to refresh his recollection on the subject, he stated he knew after two minutes that the tissue was cancerous. He conceded he had been given other expert reports in advance which reached a similar diagnosis.

   
   

3. Dr. Bickel, a practicing pathologist in Palm Beach County, also reviewed the slides in question on behalf of DPR and reached a conclusion that, in hindsight, he would have diagnosed the tissue as "suspected cancerous." He stated he would do so because of the "myxoid changes," individual cells that were more densely arranged, and the abnormal vascular pattern, all of which are signs calling for further investigation. However, he acknowledged that this was done in hindsight, and that it would have been "extraordinarily difficult" to determine if the tumor was malignant or benign in 1980. He also acknowledged having the benefit of the other DPR reports before making his examination.

   
   

4. Dr. McCann, also a DPR expert, reached the conclusion that R.C.'s tissue was a well-differentiated liposarcoma. In doing so, he admitted he was "prejudiced" in the sense he already knew the diagnosis from other reports. He also conceded that there have been "significant advances in surgical pathology since 1980" when the slides were first examined. McCann noted the presence of lipoblast (or immature) cells on R.C.'s slides. Since males of R.C.'s age should not have immature adipose tissue, he concluded this was a sign of malignancy. He also noted that "statistically" the right thigh is the most

   likely place for a male to have a malignant tumor, but was not sure if these statistics were available in 1980. Finally, he pointed out that in the general practice of pathology at hospitals such as DHLW the occurrence of this type of malignant tumor was "rare."

   
   

5. After McCann reviewed the slides, he forwarded his conclusions and the slides to the Armed Forces Institute of Pathology (AFIP), a military-operated organization in Washington, D.C., that performs pathology services for doctors throughout the nation. The AFIP diagnosis dated January 28, 1985 was as follows:

   
   

   Well differentiated liposarcoma with myxoid foci, low grade, right thigh.

   
   

   We fully agree with your diagnosis. This tumor displays both well-differentiated lipoma-like areas and prominent foci of myxoid change. These tumors may recur locally but have virtually no metastatic potential. Therapeutic considerations should include wide local excision and careful follow-up for recurrent growth.

   
   

   The AFIP report was prepared by Dr. Sharon A. Weiss, a well-known institute pathologist.

   
   

6. Of the three depositions taken in the civil malpractice case and offered in evidence in this proceeding, two focused primarily on whether there was a metastasis as opposed to independent primary tumors in R.C.'s case, a matter irrelevant to this proceeding. The third (Dr. Kime) did not directly criticize respondent, but simply had a difference of opinion on respondent's diagnosis of the slides. He believed Romaguera had deviated from the prescribed standard of care.

   
   

7. Dr. Steven I. Hajdu, who testified for respondent, is recognized by the medical community as a leading authority on the diagnosis and treatment of tumors. His testimony is found to be the most credible and persuasive in this case. He too examined R.C.'s original slides on behalf of respondent, as well as the depositions of Benz, Bickler and McCann. According to Hajdu, there is a grey area between a benign and a malignant tumor, and pathologists frequently do not make the proper distinction. If one diagnoses a benign tumor as cancer, it is a "major mistake" and can result in the patient losing his leg when in fact no cancer exists. Conversely, it is far less serious for a pathologist to incorrectly diagnose a low-grade malignancy as benign.

   
   

8. Hajdu acknowledged that Romaguera made an error in his 1980 diagnosis. However, using the standards and knowledge that existed in 1980, Hajdu stated that he too would have probably erred. Indeed, Hajdu stated that in 1980 eight or nine out of every ten pathologists would have made the same diagnosis as Romaguera. Today, with more knowledge and skill, and under present standards, Hajdu said only two or three out of every ten pathologists would make the wrong diagnosis. Given the prevailing standards and knowledge at that time, Hajdu concluded, and the undersigned so finds, that Romaguera did not deviate from the standard of care, skill and :treatment expected of a pathologist in 1980.

   CONCLUSIONS OF LAW

   
   

9. The Division of Administrative Hearings has jurisdiction of the subject matter and the parties thereto pursuant to Subsection 120.57(1), Florida Statutes (Supp. 1986).

   
   

10. According to the amended administrative complaint, for his treatment of R.C., Romaguera is charged with having failed to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions and circumstances in violation of Subsection 458.331(1)(t), Florida Statutes (Supp. 1986). The full text of the statute is as follows:

    
    

    (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. The board shall give great weight to the provisions of

    s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in indemnities being paid in excess of

    $10,000 each to the claimant in a judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross 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," shall not be construed so as to require more than one instance, event, or act.

    
    

11. The more credible and persuasive evidence clearly establishes that respondent did not fail 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 violation of the foregoing statute. Therefore, the charges in the amended administrative complaint must fail.

    
    

12. Respondent's motion to strike testimony of Drs. Wallack and Bland is denied. Their depositions are admissible under Subsection 90.804(2)(a), Florida Statutes (1985). Even so, they have been accorded little, if any, weight for the reason stated in finding of fact 24.

RECOMMENDATION

Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered finding respondent did not

violate Subsection 458.331(1)(t), Florida Statutes, and that the complaint be dismissed, with prejudice.

DONE AND ORDERED this 12th day of May, 1987, in Tallahassee, Leon County, Florida.

DONALD R. ALEXANDER

Hearing Officer

Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32301

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 12th day of May, 1987.

ENDNOTE

1/ The original administrative complaint was filed on October 28, 1986.

APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-4887

Respondent:*

1. Covered in finding of fact 7.

2. Covered in finding of fact 8.

3. Covered in finding of fact 10.

4. Covered in findings of fact 10 and 11.

5. Covered in findings of fact 5 and 12.

6. Covered in finding of fact 13.

7. Covered in finding of fact 2.

8. Covered in findings of fact 2 and 5.

9. Covered in findings of fact 13 and 14.

10. Covered in findings of fact 17 and 18.

11. Covered in findings of fact 22 and 23.

12. Covered in finding of fact 23.

13. Covered in finding of fact 16.

14. Covered in finding of fact 19.

15. Covered in finding of fact 20.

16. Covered in finding of fact 21.

17. Rejected as irrelevant.

18. Covered in finding of fact 24.

19. Covered in finding of fact 24.

20. Covered in finding of fact 24.

21. Rejected as being legal argument.

22. Covered in finding of fact 19.

23. Covered in findings of fact 19 and 25.

24 - 29. Not used since these are conclusions of law.

*Respondent filed an admixture of unnumbered paragraphs containing findings of fact and conclusions of law. The paragraphs have been ruled upon in sequential order.

COPIES FURNISHED:

Stephanie A. Daniel, Esquire

130 North Monroe Street Tallahassee, Florida 32399-0750

Charles C. Powers, Esquire Michael S. Smith, Esquire Post Office Box 15021

West Palm Beach, Florida 33409

Ms. Dorothy J. Faircloth Executive Director

Florida Board of Medical Examiners

130 North Monroe Street Tallahassee, Florida 32399-0750

Docket for Case No: 86-004887

Orders for Case No: 86-004887