STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

BETHESDA MEMORIAL HOSPITAL, ) RUSSELL T. CLAYTON, ADMINISTRATOR, )

)

Petitioner, )

)

vs. ) CASE NO. 77-677

)

OFFICE OF COMMUNITY MEDICAL ) FACILITIES, 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, in Room 217, Winewood Building No. 1, 1323 Winewood Boulevard, Tallahassee, Florida at 10:00 a.m. on May 3, 1977. Upon the stipulation of the parties, the hearing was officially closed on May 24, 1977, the date of receipt of the transcript.

APPEARANCES

For Petitioner: Fred W. Baggett

LaFace and Baggett, P.A.

101 East College Avenue Tallahassee, Florida

For Respondent: Eric J. Haugdahl

Department of Health and Rehabilitative Services

1323 Winewood Boulevard, Room 406

Tallahassee, Florida 32301 FINDINGS OF FACT

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

1. Petitioner Bethesda Memorial Hospital, located in Boynton Beach, Palm Beach County, Florida, is a fully accredited, nonprofit tax-assisted 300 bed hospital. It timely submitted its application for a certificate of need for the establishment of a coronary angiography laboratory. The present facility includes a special procedures room which is used for arteriograms and other radiological studies. This existing space will be available as part of the expanded use of the special procedures room for coronary arteriography. For this reason, petitioner proposes no new construction and construction costs are not included in petitioner's proposed costs of approximately $230,000.00, one- half of which has already been obtained through donations. Petitioner's facility now has the equipment and capacity to perform studies on all vessels

   but the heart vessels. It wishes to expand its services and capabilities to include cardiac catheterization procedures.

   
   

2. It is projected by petitioner that for the first two years of operation, the proposed cardiac catheterization lab will respectively perform

   200 and 250 procedures per year. This projection is based on population statistics indicating 600 possible patients who would be candidates for the procedure, and an assumption that only one-third of this number would avail themselves of the service. The projected number also takes into account the fact that a start-up period is necessary to allow others to hear about the lab and to obtain referrals. It was opined that if the projections were carried out beyond two years, the figures would reach 300. At this time, petitioner does not intend to operate its lab in conjunction with an open heart surgery program.

   
   

3. Cardiac catheterization is a diagnostic and prognostic tool utilized to discover the condition of the coronary arteries and the extent, presence or absence of heart disease. It is an invasive technique and therefore involves some risk factor. There is an inverse relationship between mortality, morbidity and complication rates and the number of cardiac catheterization performed in any given facility. As volume and experience increase, the percentage of mortality and morbidity decrease. From a proficiency standpoint, a reasonable utilization rate is 300 procedures per year. Cardiac catheterization laboratories are capable of comfortably performing three to four procedures per day or approximately 750 to 1,000 annually.

   
   

4. In the "Report of the Inter-Society Commission for Heart Disease Resources," it is concluded that

   
   

   "Optimally. . .catheterization laboratories should be located only in institutions with well organized and closely related programs of cardiovascular surgery." (Exhibit 1, p. A-4)

   
   

   It was the opinion of petitioner's witness, a cardiologist, that an immediately available surgical program is not a medical necessity for the establishment of a cardiac catheterization lab. He estimated that only one-third of the catheterizations performed result in ultimate surgery and that very few of these are of an emergency nature. To include a surgical program in its proposal, the estimated cost would go from $200,000.00 to $1,000,000.00. It was his opinion that a facility which has an open-heart surgical program often tends to try to generate more catheterizations to justify the program. This witness indicated that petitioner might reconsider a surgical program at a later time.

   
   

5. Medically speaking, it is not dangerous for a non-emergency patient to travel some distance for a cardiac catheterization. However, from a professional standpoint, patient confidence may be diminished when the patient is required to go to another facility with a different and new physician in charge. Anxiety and costs to the patient may be increased by travel, family accompanying the patient and duplication of x-rays and other tests.

   
   

6. Petitioner's facility is located in an area known as Region 7. This region's Health Planning Council serves five counties - - Indian River, Martin, Okeechobee, Palm Beach and St. Lucie Counties. Region 7 extends approximately

   100 miles in length. Petitioner's facility is located in the southernmost part of the Region, about 15 miles north of the Broward County line. There are no coronary angiography laboratories located in Region 7. Ft. Lauderdale, located about 30 miles from petitioner's facility, presently has four such labs in

   operation, each of which operates in conjunction with an open-heart surgical program. During the year 1976, these four labs performed respectively 391, 217,

   475 and 95 catheterizations. The Broward County facilities are accessible by three major highways - - U.S. 1, I-95 and the Florida Turnpike. From eight to eleven labs are in operation in Dade County. Petitioner's witness presently refers his catheterization patients to St. Francis Hospital in Miami and to North Ridge Hospital in Ft. Lauderdale. He has experienced no problems or delays when referring patients to Broward County.

   
   

7. Petitioner's application for a certificate of need was referred to the Health Planning Council, Inc., (HPC), the health systems agency serving Region 7, for initial review, comments and recommendations. The staff of the HPC did an analysis of the application, using the Inter-Society Commission Report as a basis. Doctors and hospital administrators in the community were consulted and the staff considered the information contained in petitioner's application. Rather than recommending approval or disapproval of the application, the Staff Report listed three factors supporting approval and three supporting disapproval. These were:

   
   

   1. Recommendations

      
      

      Factors supporting approval of Certificate of Need:

      1. As stated in the application, the proposed catheterization laboratory will "afford better patient care by providing a very effective diagnostic study performed in the home area of the patient with a resulting feeling of

         comfort and convenience.

      2. The application states that such a catheterization laboratory will "provide necessary first hand diagnostic information on patients to the physicians and allow timely, knowledgeable decisions about the patients' treatment."

      3. By providing such a laboratory within the hospital, the application states that such a service will "attract young, well trained physicians interested in affiliating with a well equipped, progressive hospital."

         
         

         Factors supporting disapproval of Certificate of Need:

         1. Based on the information found in the application and the planning guidelines developed by the ISC, the proposed laboratory would not be efficiently or effectively utilized. At the same time, the facilities in Miami are of sufficient capability to meet the current needs of the Palm Beach area's population.

         2. The issue of patient safety and related back-up facilities as stated in the ISC report would indicate that such procedures should not be carried out at BMH.

         3. The ISC report indicates that "catheterization laboratories should be

         located only in institutions with well organized and closely related programs of cardiovascular surgery. Because BMH does not at this time have such a surgery program, the development of such a laboratory within the hospital is not advisable.

         
         

8. The application was then considered by the Health Facilities Committee of the HPC. After receiving comments from proponents and opponents and from the Staff, the Committee voted to disapprove the request by a vote of 9 to 3, with two abstentions. The Committee relied upon the three factors for disapproval set forth in the Staff Report.

   
   

9. The Board of Directors of the Health Planning Council, by a vote of 15 to 6, voted to recommend approval of petitioner's application for a certificate of need. The Council relied upon the three factors supporting approval set forth in the Staff Report.

   
   

10. By letter dated March 4, 1977, respondent notified petitioner that it did not favorably consider petitioner's capital expenditure proposal. As reasons therefore, respondent found that the availability of four underutilized laboratories in Ft. Lauderdale which is within a reasonable distance from petitioner outweighed the factor of desirability of having such services performed in the home area of the patient. Also, respondent noted the Inter- Society Commission's Report which states that 300 catheterizations per year should be accomplished for the maintenance of proficiency and reduction of risk to patients and that catheterizations should be performed only at centers where cardiac surgery is regularly performed. Respondent found that petitioner's application did not meet these two qualifications. Respondent's medical facilities specialist and supervisor of the certificate of need section based his recommendation of denial upon a consideration of the HPC's staff analysis, minutes of the Committee and Board of Director's meetings, the Report of the Inter-Society Commission and his recollection of the testimony given in another "fair hearing" case involving the application of Holy Cross Hospital for a catheterization laboratory.

    
    

11. Petitioner timely requested a hearing on respondent's denial of its capital expenditure proposal and the undersigned Hearing Officer was duly designated to conduct the hearing.

    
    

    CONCLUSIONS OF LAW

    
    

12. It appears from the evidence, and the parties so stipulated, that petitioner gave timely notice of its intention to make a capital expenditure and that respondent timely complied with the procedural requirements of state and federal law.

    
    

13. The remaining issue is therefore whether petitioner's proposal for the establishment of a coronary angiography laboratory is consistent with existing plans, standards and criteria developed pursuant to the Public Health Service Act. Although the respondent's letter of denial (Exhibit 4) does not refer by citation to any specific criteria, it is clear from said letter and from the respondent's stipulation at the hearing that the bases for denial were three - - lack of demonstrated need, doubts as to the maintenance of proficiency and patient safety, and failure to operate in conjunction with open heart surgery.

14. The prime criterion against which a capital expenditure proposal is to be evaluated is than the project be necessary to meet the needs of the community in terms of health services required. 42 C.F.R. 100.101 et seq. Among the factors against which such necessity is to be determined are whether or not the project can be adequately staffed and operated when completed and the availability, accessibility and adequacy of health care services in the area's existing facilities. F.S. 381.494(5)(c) and F.A.C. Ch. 101-1.03(c)(3) and (6). In this case the respondent found, after a review of the projections made in the petitioner's own application, the staff analysis, the minutes of the HPC's meetings, and the Inter-Society Report, that these criteria had not been met by petitioner.

    
    

15. The respondent determined that a cardiac catheterization laboratory could not be operated adequately, in terms of patient safety, proficiency and efficiency, absent the accomplishment of at least 300 catheterizations a year and absent the regular performance of cardiac surgery at the same facility. The evidence adduced at the hearing supports this finding by respondent. There was no conflict in the evidence as to the reasonableness of the number of 300 procedures to maintain proficiency. While there was some conflict as to whether a cardiac surgery program operating in conjunction with a catheterization lab is medically necessary, the overwhelming evidence was to the effect that such was a desirable or optimum condition. This, coupled with the fact that there are four underutilized labs in Broward County which do operate in conjunction with surgical programs, supports respondent's bases for denial of petitioner's proposal.

    
    

16. Finally, petitioner has failed in its burden to illustrate that the existing facilities in Broward and Dade Counties are unavailable, inaccessible or inadequate to patients residing in Palm Beach County or the residents of Region 7. The facilities in Broward County are located only about 30 miles from petitioner's facility. There was no evidence that patients from Region 7 suffered any delay in the utilization of such facilities. From a medical standpoint, requiring a patient to travel that far is not physically dangerous. There was also evidence that if a catheterization laboratory were needed in Region 7, it should be placed in a more geographically centralized location within the Region. The most populous area of the 100-mile length Region is the northern area encompassing the Palm Beaches. Petitioner's facility is located in the southeastern area, only 15 miles from the Broward County line. Thus, petitioner's proposed facility would be only slightly more available and accessible to the residents in Region 7 than those existing labs in Ft. Lauderdale.

    
    

17. In conclusion, it is found that petitioner's capital expenditure proposal is not in conformity with the existing criteria for the reasons set forth in the respondent's letter of denial.

RECOMMENDATION

Based upon the findings of fact and conclusions of law recited above, it is recommended that petitioner's application for a certificate of need to establish a coronary angiography laboratory be denied.

Respectfully submitted and entered this 7th day of July, 1977, in Tallahassee, Florida.

DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304

(904) 488-9675

COPIES FURNISHED:

Mr. Art Forehand, Administrator

Office of Community Medical Facilities 1323 Winewood Boulevard

Tallahassee, Florida 32301

Fred Baggett, Esquire LaFace and Baggett, P.A.

101 East College Avenue Tallahassee, Florida 32304

Eric J. Haugdahl, Esquire Department of Health and

Rehabilitative Services

1323 Winewood Boulevard, Room 406

Tallahassee, Florida 32301

Docket for Case No: 77-000677

Orders for Case No: 77-000677