STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

MARVIN W. JOHNSON, M.D., )

)

Petitioner, )

)

vs. ) CASE NO. 78-171

)

DEPARTMENT OF HEALTH AND )

REHABILITATIVE SERVICES, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, an administrative hearing was held before Diane D. Tremor, Hearing Officer with the Division of Administrative Hearings, on May 12, 1978, at the Polk County Health Department in Winter Haven, Florida.

APPEARANCES

For Petitioner: Jack T. Edmund

Post Office Box 226 Bartow, Florida 33830

For Respondent: Anthony N. DeLuccia, Jr.

District VIII Counsel Department of Health and

Rehabilitative Services Post Office Box 2258

Fort Myers, Florida 33902 FINDINGS OF FACT

Upon consideration of the relevant oral and documentary evidence adduced at the hearing, the following facts are found:

1. At all times pertinent to this proceeding, Marvin W. Johnson was duly licensed medical doctor specializing in the area of pathology.

   
   

2. On December 9, 1977, Dr. Johnson made application to Respondent for registration of a clinical laboratory pursuant to Florida Statutes, Chapter 483. The address listed on the application was 1104 Bryn Mawr Avenue, Lake Wales, Florida. This was the address of the Lake Wales Medical Laboratory, Incorporated.

   
   

3. The Lake Wales Medical Laboratory was operated by William Atkinson, who was licensed in the areas of chemistry, hematology, urinalysis and microbiology. The Lake Wales Laboratory was licensed for the specialties of bacteriology, serology, clinical chemistry, hematology and immunohematology. This lab referred all cytological and histopathological work out to other laboratories. Mr. Atkinson had an extra room in this lab and felt that it would be helpful to

   the patients if a local pathologist could perform the cytology and histopathology work. After checking with at least twenty local physicians as to Dr. Johnson's qualifications as a pathologist, Mr. Atkinson offered the use of the extra room to Dr. Johnson for the purpose of "get[ting] into this business." For two to three weeks prior to December 9, 1977, Dr. Johnson used the room at the Lake Wales Medical Laboratory. During this time, he had no equipment.

   While Mr. Atkinson did observe Dr. Johnson stain some slides, it was not known whether this work was being done for his own patients.

   
   

4. On December 9, 1977, Respondent's Office of Laboratory Services received a telephone call from the administrator of the Bond Clinic in Winter Haven inquiring whether or not there was a licensed cytology and histopathology lab at the Lakes Wales Medical Laboratory. This office also received a letter from said administrator which enclosed a photocopy of a pathology fee list and a bill head with Dr. Johnson's name and the Lake Wales Medical Laboratory address. No competent evidence was adduced as to the use or purpose of these documents. Also Mr. Atkinson wrote a letter to Mrs. Carter in the Respondent's Office of Laboratory Services which stated in part that "pathology and cytology will no longer be performed in this building." This letter was dated December 9, 1977. As noted above, it was Mr. Atkinson's testimony at the hearing that he never did observe Dr. Johnson perform pathological services at the Lake Wales lab. While he did observe some staining of slides, he had no knowledge as to whether this was done for patients other than his own.

   
   

5. On December 12, 1977, Respondent's Office of Laboratory Services received Dr. Johnson's application for a license to open a laboratory in the specialties of cytology and histopathology at the Lake Wales address. A surveyor for the clinical laboratory improvement program, Robert Bentz, went to the Lake Wales address to make an inspection of the laboratory on December 23, 1977. He found that the lab did not exist at that address. Mr. Bentz contacted Dr. Johnson and was informed that the lab would be located in Winter Haven. He then went to the Winter Haven address and found that Dr. Johnson had adequate space to operate a laboratory and that he had the necessary equipment and reagents. Mr. Bentz told Dr. Johnson to change the address on his application for registration and then gave him a verbal interim approval to perform the laboratory procedures in the specialty of cytology at the Winter Haven lab.

   
   

6. By letter dated January 6, 1978, Petitioner was informed by Nathan J. Schneider, Respondent's Director of the Office of Laboratory Services, that his application for registration had been denied. As reasons therefore, Dr. Schneider stated:

   
   

   that facility is not in compliance with the provisions of the Florida Clinical Laboratory Law, Section 4893.091 F.S. which states that no person shall conduct, maintain, or operate a clinical laboratory in this state unless a registration therefor has been obtained from the Department of Health and Rehabilitative Services; Section 483.201 which states that a laboratory registration may be denied for demonstrating incompetence or making consistent errors in the performance of clinical laboratory examinations and procedures or reporting which is erroneous, violating or aiding and abetting in the violation of any provision of this chapter or

   rules promulgated hereunder, for failing to file any report required by the provisions of this chapter; and Section 483.23 operating, maintaining, directing or engaging in the business of operating a clinical laboratory, as herein defined, without obtaining a clinical laboratory license from the Department of Health and Rehabilitative Services or is exempt under Section 483.031."

   
   

7. Respondent has been involved in federal litigation concerning his operation of a plasma center. That litigation is still pending and Respondent has failed to show, by competent evidence, its relevance to the issues in this proceeding.

   
   

   CONCLUSIONS OF LAW

   
   

8. Florida Statutes, Sections 483.091 and 483.23(1) make it unlawful for any person to conduct, maintain, operate, direct or engage in the business of operating a clinical laboratory unless he has obtained a registration or license therefore from the Respondent or unless he is exempt pursuant to Section

   483.031. The pertinent portion of that exemption is for labs operated by five or less licensed practitioners exclusively in connection with the diagnosis and treatment of their own patients. Respondent has denied Petitioner's application for registration on the grounds of violating Sections 483.091 and 483.23(1). Further, Respondent cites portions of Florida Statutes Section 483.201 as grounds for denial. Specifically, Respondent makes reference to the language contained in subsections (3), (6) and (7) of Section 483.201.

   
   

9. An applicant for registration or licensure has the burden to demonstrate his qualifications to hold the same. Here, the parties stipulated that Dr. Johnson was a duly licensed medical doctor specializing in the area of pathology. Thus, unless Respondent can illustrate a sufficient basis for denial, the Petitioner has met his burden to demonstrate his qualifications.

   
   

10. Respondent has totally failed in this proceeding to justify its basis for denial of Petitioner's application. There has been no adequate showing that Petitioner operated, conducted or maintained a clinical lab at the Lake Wales facility. The very most that can be gleaned from the evidence adduced at the hearing is that Dr. Johnson stained a few slides at the Lake Wales facility. There was no further evidence as to these slides. It is reasonable to assume that these slides concerned his own patients, thus falling within the exempt status of Florida Statutes Section 483.031(2). The fee schedule and statement received into evidence, by themselves, prove nothing.

    
    

11. Nor has Respondent presented any evidence regarding the allegation of erroneous reporting, incompetence, making consistent errors or a violation of other statutory or regulatory provisions. The mere fact that Petitioner has been involved in federal litigation in connection with the operation of another facility, which litigation is still pending, is not, by itself, sufficient to illustrate these alleged violations.

    
    

12. In summary, Petitioner has illustrated that he is qualified to be registered and/or licensed pursuant to Florida Statutes, Chapter 483, Part I. Respondent has failed to present adequate evidence which supports the basis for denial as stated in its letter dated January 6, 1978.

RECOMMENDATION

Based upon the findings of fact and conclusions of law recited above, it is recommended that Respondent's letter of denial of registration to Petitioner be rescinded and that Petitioner's application for registration be GRANTED.

DONE AND ENTERED this 13th day of July 1978 in Tallahassee, Florida.

COPIES FURNISHED:

Secretary William J. Page, Jr. Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32301

Jack T. Edmund

Post Office Box 226 Bartow, Florida 33830

Anthony N. DeLuccia, Jr. District VIII Counsel Department of Health and

Rehabilitative Services Post office Box 2258

Ft. Myers, Florida 33902

DIANE D. TREMOR

Hearing Officer

Division of Administrative Hearings

101 Collins Building

Mail: 530 Carlton Building Tallahassee, Florida 32304

(904) 488-9675

Docket for Case No: 78-000171

Orders for Case No: 78-000171