HERMAN E. DECKER, ASSISTANT ) DIRECTOR HOSPITAL SERVICES, HOLY ) CROSS HOSPITAL, )
vs. ) CASE NO. 76-002
) OFFICE OF COMMUNITY MEDICAL ) FACILITIES, STATE OF FLORIDA, ) DEPARTMENT OF HEALTH AND )
Intervenor. )
Pursuant to notice, an administrative hearing was held in Tallahassee, Florida, before Diane D. Tremor, Hearing Officer with the Division of Administrative Hearings, commencing on January 26, 1976, and continuing on March 2, 1976, June 25, 1976, and September 8, 1976. Upon the stipulation of the parties the hearing was officially closed on September 24, 1976, the date of receipt of the transcript.
For Petitioner: Mr. William F. Leonard
Coleman, Leonard & Morrison 2810 E. Oakland Park Boulevard Fort Lauderdale, Florida 33306
For Respondent: Mr. Douglas E. Whitney
For Intervenor: Mr. Sheldon M. Simons
Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found:
On or about June 9, 1975, petitioner Holy Cross Hospital filed with respondent its certificate of need application for the expansion of angiographic service facilities. The applicant is a 597-bed, privately operated, nonprofit and fully accredited medical center located in Fort Lauderdale, Florida. Petitioner seeks to add to its existing facility a laboratory for cardiac catherization and coronary angiography. The application was referred to the Broward County Community Health Planning Council (hereinafter referred to as BCCHPC) for initial review, comments and recommendations.
On July 14, 1975, the staff of the BCCHPC issued its Staff Analysis on petitioner's capital expenditure proposal. This document concludes that the proposal "can conceivably be construed as duplication of services." Among the factors considered by the staff were the existence of two hospital-based cardiac catherization diagnostic programs within Broward County and their capacities and utilization rates; the opening of a third hospital-based facility around mid- October of 1975; and the standards and guidelines for cardiac diagnostic centers as reported by the American Heart Association. It was concluded that the presently existing facilities were being utilized at a rate of ten percent of their combined capacity of 1,750 procedures per year, and that the third facility to be opened in mid-October would provide an additional capability of 1,000 procedures per year. (Exhibit No. 4)
The Project Review Committee of the BCCHPC met on July 24, 1975, to review the petitioner's proposal. After hearing the views of both proponents and opponents to the application, this Committee voted to postpone its recommendation with the understanding that an impartial panel of experts, under the auspices of the Broward County Heart Association, would be brought in to review the needs of the community for additional angiographic services. An extension of the review period to December 1, 1975, was thereafter sought by petitioner and granted by respondent. (Exhibit No. 7.) For one reason or another, the survey was never conducted.
On October 17, 1975, the staff of the BCCHPC issued its second staff summary. This second report, although differing in some figures and statistics from the first report, again concluded that current and projected utilization barely justifies the two existing facilities. It recognized the third facility to be opened shortly at North Ridge General Hospital and found that the applicant's proposal would be additionally counterproductive, reducing overall quality and increasing average cost. (Exhibit No. 5.)
Thereafter, on October 27, 1975, the Project Review Committee of the BCCHPC again met to review petitioner's application. In addition to a representative for the applicant, the Committee heard the opposing views of North Ridge General Hospital, which included the presentation of an analysis as to need for additional cardiovascular diagnostic laboratory services in Broward County. This analysis was prepared by Lillian Guralnich, a biostatistician, and concluded that (based upon actual utilization rates in Dade County) a valid statistical estimate of potential cases requiring the subject diagnostic studies in Broward County is 2,500 per year, and that the existing facilities and the soon-to-be-opened North Ridge facility would provide a capacity substantially in excess of such estimated demand. Additionally, the Committee heard the view of Dr. Manuel Viamonte, a member of the Inter-Society Commission for Heart Disease Resources, that an additional catherization laboratory in Broward County would be counterproductive. A motion to accept petitioner's application was defeated by a vote of five to two, with six abstentions. (Exhibit No. 5.)
The BCCHPC met on October 30, 1975, to discuss the Project Review Committee's recommendations. The Council heard a presentation in support of the proposed laboratory and were presented supporting documents. North Ridge again spoke in opposition and again presented the Guralnich analysis concerning need. The study of the Inter-Society Commission on Heart Disease Resources was also presented. Thereafter, the Committee unanimously voted, by a vote of 17-0 with two abstentions, to deny petitioner's application. (Exhibits A, C and U.)
By letter dated November 24, 1975, Mr. Art Forehand notified petitioner that all the reviewing agencies (the BCCHPC, the Office of Comprehensive Health Planning, and the Office of Community Medical Facilities) had not favorably considered petitioner's capital expenditure proposal. The reason given for such unfavorable consideration was that there were three existing, underutilized cardiac catherization labs in Broward County and that the creation of an additional lab at petitioner's facility would be a duplication of services, an unnecessary capital expenditure and would not lend itself to health care cost containment concepts. (Exhibit D.) The petitioner was advised of its right to a fair hearing, stated its desire to avail itself of such right, and the undersigned Hearing Officer was assigned to conduct the hearing.
Holy Cross Hospital opened on December 7, 1955, and enjoys a good reputation among both physicians and the community at large. It is a full service hospital with 597 beds, 498 of which are staffed. Last year, some 2,100 heart patients were admitted to Holy Cross. Petitioner did its first open heart surgery on November 23, 1975, and, as of January 26, 1976, had performed a total of eight such procedures. The pre-surgery catherizations were performed at other hospitals without difficulties in scheduling or transportation.
Cardiac catherization is a diagnostic tool utilized to discover the condition of the coronary arteries. It is an invasive technique involving the insertion of a small flexible tube into the veinous or arterial system and passing it by way of a peripheral vein or artery into the heart or the major structures of the great vessels arising from the heart. While the first procedures began in the early 1940's, the technique is a relatively new development within the past ten to fifteen years. The procedure determines the location and severity of coronary obstructions and is a definitive method to rule out a diagnosis of heart disease. It provides a confirmation of the less risky non-invasive techniques (such as the clinical treadmill tests, radiological studies, etc.) and is a prelude to coronary artery surgery. Such a procedure would be unnecessary if the patient were unable or unwilling to undergo heart surgery. Approximately ninety percent of such catherizations are done electively, as opposed to a ten percent emergency usage. Emergency patients are generally nontransportable, but there is no problem or risk in transporting the ninety percent elective patients to other facilities for the purpose of catherization. While not mandatory, it is desirable to have heart surgery facilities and capabilities at the same hospital as the catherization laboratory.
There is an inverse relationship between mortality, morbidity and complication rates and the number of cardiac catherizations performed in any given facility. When volume and experience increases, complications decrease. Also, underutilization of a cardiac catherization laboratory often results in higher patient costs and unnecessary procedures being performed. The minimally acceptable utilization rate for any given facility is 300 procedures per year.
The estimates of the actual and potential need for catherization procedures in Broward County varied widely. It ranged from a high of 20,000
present potential candidates for the procedure to a low of 2,500 potential cases per year. Factors affecting need include the education of the public and physicians, the reputation and persuasive abilities of the treating physician, cost and risk to the patient, adequacy and reputation of the lab, and professional limitations. Professional opinions and philosophies differed as to the use of cardiac catherization. While one physician felt that no more than ten percent of patients with heart disease needed such a procedure, another felt that the procedure was necessary to detect the absence of heart disease as well as its presence and that every good hospital should have such a lab.
There are presently three hospital-based cardiac catherization laboratories in Broward County. One lab, which opened in September of 1974, exists at Broward General Medical Center, located some eight to ten miles from petitioner. Another, opening in October of 1974, exists at Florida Medical Center Hospital, formerly called Lauderdale Lakes General Hospital and located approximately six miles from Holy Cross Hospital. A third lab was opened in November of 1975 and is located about one mile from petitioner at North Ridge General Hospital, the intervenor in this proceeding. Testimony differed as to the actual daily or monthly number of procedures capable of being performed at these institutions. The highest figure given was that of Dr. Frank Masone Sones, a world renown authority on coronary angiography. He stated that a diagnostic laboratory of this sort can easily perform ten or twelve, and under real stress, fifteen procedures per day. This would average out to 60 per week or 3,000 per year per facility if the figure of 12 were used. This figure assumes an eight-hour shift. Another physician testified that most labs could perform four catherizations per day.
Actual catherizations performed at two of the existing labs in Broward County average out to be 20 per month and 33 per month. The capability figures given for the three existing facilities based upon one eight-hour shift, totalled 2,700 procedures annually. One hospital administrator testified that its lab could perform six per day on an eight-hour shift, or 120 per month. This administrator saw no difficulty with operating two shifts, should the need arise.
CONCLUSIONS OF LAW
It appears from the evidence that the petitioner gave timely notice of its intention to make a capital expenditure and that the respondent timely, and within the bounds of the requested extension, complied with the procedural requirements of state and federal law. Although the reason for the extension was to obtain an independent survey as to need in Broward County, and this survey was never undertaken, petitioner has failed to illustrate that it was prejudiced thereby or that it timely objected to ultimately going forward without the survey.
The remaining issue is therefore whether petitioner's proposal for expanded angiographic facilities is consistent with existing plans, standards and criteria developed pursuant to the Public Health Service Act. After carefully considering all the relevant oral and documentary evidence adduced at the hearing, it is the conclusion of the undersigned hearing officer that petitioner has failed to show consistency and compliance with existing criteria.
The stated purpose of Sec. 1122 of the Social Security Act, as well as the state law implementing said section, is to assure that federal funds are not used to support unnecessary capital expenditures. Among the specific criteria against which the proposal is to be evaluated is that the project be necessary
to meet the needs of the community in terms of health services required. When evaluating the criteria of need the extent of utilization of existing facilities must be considered.
While the evidence regarding actual and potential needs in the Broward County area differed widely, one cannot escape the fact that two of the existing facilities there, each of which has been in operation for over a year, were performing an average of only 20 and 33 procedures a month. Using even the lowest estimates regarding the capabilities of these two facilities, such averages fall far below an acceptable utilization rate. As noted in the findings of fact, underutilization of an existing facility may result in higher costs to patients, higher mortality, morbidity and complication rates and the performance of unjustified or unnecessary procedures. There is no doubt that the existing facilities in Broward County are presently underutilized and that the existence of yet another facility would result in an unnecessary duplication of similar facilities.
Using the higher capability figures of the three existing cardiac catherization laboratories -- 3,000 per year per facility -- a total of 9,000 procedures could be accomplished without additional shifts, manpower or equipment. Until an apparent, actual need figure begins to approach this amount, there is no need for an additional facility offering this service in Broward County. The addition of such a facility would not foster cost containment and would be an unnecessary duplication of existing facilities.
Based upon the findings of fact and conclusions of law recited above, it is recommended that the determination of the Office of Community Medical Facilities to deny petitioner's application for the expansion of angiographic service facilities be upheld.
Respectfully submitted and entered this 4th day of November, 1976, in Tallahassee, Florida.
DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304
Mr. William F. Leonard Coleman, Leonard & Morrison 2810 E. Oakland Park Boulevard
Mr. Douglas E. Whitney Attorney
Mr. Sheldon M. Simons professional Building 3661 South Miami Avenue Miami, Florida 33133
