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ST. MARY'S HOSPITAL, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 87-002729RX (1987)

Court: Division of Administrative Hearings, Florida Number: 87-002729RX Visitors: 18
Judges: ELLA JANE P. DAVIS
Agency: Department of Health
Latest Update: Nov. 13, 1987
Summary: Petitioner, St. Mary's, and Intervenor, BRCH contend that Rule 10- 5.011(1)(f), Florida Administrative Code, constitutes an invalid exercise of delegated legislative authority for the reasons more specifically set forth in St. Mary's Amended Petition for Administrative Determination of the Invalidity of a Rule. Respondent, HRS, and Intervenors, JFK, PBGMC, and Florida Hospital, contend that Rule 10-5.011(1)(f), Florida Administrative Code, constitutes a valid exercise of delegated legislative au
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87-2729

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS


ST. MARY'S HOSPITAL, )

)

Petitioner, )

)

vs. ) CASE NO. 87-2729RX

)

DEPARTMENT OF HEALTH AND )

REHABILITATIVE SERVICES, )

)

Respondent, )

and )

)

JOHN F. KENNEDY MEMORIAL ) HOSPITAL, PALM BEACH GARDENS ) MEDICAL CENTER, BOCA RATON ) COMMUNITY HOSPITAL, and )

FLORIDA HOSPITAL, )

)

Intervenors. )

)


FINAL ORDER


This case arises as a rule challenge pursuant to Section 120.56, Florida Statutes. Notice was provided and a formal administrative hearing held on July 27, 28 and 29, 1987, in Tallahassee, Florida, before Ella Jane P. Davis, Hearing Officer of the Division of Administrative Hearings.


APPEARANCES


For Petitioner, St. Mary's Hospital (St. Mary's):

W. David Watkins, Esquire Post Office Box 6507

Tallahassee, Florida 32314-6507


For Intervenor, Boca Raton Community Hospital (BRCH): Darrell White, Esquire

Post Office Box 2174 Tallahassee, Florida 32316-2174


For Respondents Department of Health and Rehabilitative Services (HRS):

Lesley Mendelson, Esquire Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700

For Intervenor, John F. Kennedy Hospital (JFK):

Robert A. Weiss, Esquire The Perkins House

118 North Gadsden Street Tallahassee, Florida 32302


For Intervenor, Palm Beach Gardens Medical Center (PBGMC): Robert S. Cohen, Esquire

John F. Gilroy, Esquire Post Office Box 10095 Tallahassee, Florida 32302


For Intervenor, Florida Hospital (Fla. Hospital):

Robert T. Klingebeil, Esquire 1001 Avenida del Circo

Post Office Box 1596 Venice, Florida 34284


ISSUE


Petitioner, St. Mary's, and Intervenor, BRCH contend that Rule 10- 5.011(1)(f), Florida Administrative Code, constitutes an invalid exercise of delegated legislative authority for the reasons more specifically set forth in St. Mary's Amended Petition for Administrative Determination of the Invalidity of a Rule. Respondent, HRS, and Intervenors, JFK, PBGMC, and Florida Hospital, contend that Rule 10-5.011(1)(f), Florida Administrative Code, constitutes a valid exercise of delegated legislative authority.


BACKGROUND AND PROCEDURE


Petitioner, St. Mary's, presented the oral testimony of Philip Rond, W. Eugene Nelson-Michael L. Schwartz, and James McElreath. Petitioner submitted 9 exhibits at formal hearing, 8 of which were admitted in evidence. Pursuant to a stipulation among the parties, St. Mary's subsequently had admitted an after- filed deposition of Frank R. Sloan. Intervenor BRCH had admitted in evidence 1 exhibit but called no witnesses. Respondent HRS presented the oral testimony of Elfie Stamm and Reid Jaffe. Respondent HRS had 4 exhibits admitted in evidence. At formal hearing, Intervenors JFK and PBGMC presented the oral testimony of Mark Richardson which was also adopted by HRS as its own. Pursuant to a stipulation among the parties, JFK and PBGMC subsequently had admitted an after- filed deposition of Harold B. Luft which was also adopted by HRS. Official recognition of JFK's Petition in DOAH Case No. 86-4368 was granted. PBGMC had 1 exhibit admitted in evidence at formal hearing. Intervenor Florida Hospital, submitted no exhibits and adopted the testimony of HRS' witnesses. The Hearing Officer received two documents into evidence as Hearing Officer Exhibits, the Prehearing Stipulation between the parties in this proceeding and a copy of Rule 10-5.011(1)(f), Florida Administrative Code. Official recognition was taken of the Final Order dated July 27, 1987, in St. Francis Careunit v. Department of Health and Rehabilitative Services, et al., DOAH Case No. 84-2918.


Subsequent to the filing of the transcript herein, and pursuant to time waivers and stipulations among the parties, St. Mary's and BRCH filed their joint proposed final order; JFK and PBGMC filed their joint proposed final order; and HRS and Florida Hospital filed individual respective proposed final orders. The parties' respective proposed findings of fact are ruled upon in the Appendix to this Final Order, pursuant to Section 120.59(2), Florida Statutes.

Additionally HRS' Motion to Strike Portions of the Joint Proposed Findings of

Fact of St. Mary's and Intervenor BRCH, and JFK's Motion to Strike are ruled upon within this Final Order and its Appendix.


FINDINGS OF FACT


  1. St. Mary's is an existing general acute care hospital in HRS Service District 9, West Palm Beach, Florida. St. Mary's has pending before the Division of Administrative Hearings DOAH Case No. 86-4368 concerning its certificate of need (CON) application for an open heart surgery program at St. Mary's which was preliminarily denied by HRS (CON Action No. 4551). Rule 10- 5.011(1)(f), Florida Administrative Code, was utilized by HRS in evaluating St. Mary's CON application and was relied upon by HRS in its decision to deny CON Action No. 4551. Pursuant to that HRS review, there is no numerical need for the St. Mary's proposed program, based upon HRS' application of the quantitative need methodology contained in the Rule. St. Mary's is substantially affected by Rule 10-5.011(1)(f), Florida Administrative Code, and consequently has standing to seek administrative determination of the validity of said rule through this present cause.


  2. BRCH is an existing general acute care hospital in HRS Service District 9, Boca Raton Florida. BRCH has pending before HRS a CON application for an open heart surgery program at BRCH (CON Application No. 5194) which is currently being reviewed by HRS in accordance with Rule 10-5.011(1)(f), Florida Administrative Code. BRCH is substantially affected by Rule 10-5.011(1)(f), Florida Administrative Code, and consequently has standing to seek administrative determination of the validity of said rule through this present cause.


  3. JFK is an existing general acute care hospital in HRS Service District 9, Lake Worth, Florida, which has in place its open heart surgery program. JFK's open heart surgery program opened and closed in 1986. On the date of formal hearing, JFK had scheduled to reopen its open heart surgery program in August, 1987. The program is subject to regulation pursuant to Sections 381.493-499, Florida Statutes, (1985), and regulations promulgated thereunder, including Rule 10-5.011(1)(f), Florida Administrative Code. JFK is an Intervenor in opposition to St. Mary's application in DOAH Case No. 86-4368 alleging that due to the service area and medical staff overlaps between St. Mary's and JFK, there will be adverse staffing, economic, availability, and quality impacts upon JFK.


  4. PBGMC is an existing general acute care hospital in HRS Service District 9, Palm Beach Gardens, Florida, which has in place an open heart surgery program. Its program is likewise subject to regulation pursuant to Sections 381.493-499, Florida Statutes (1985), and regulations promulgated thereunder, including Rule 10-5.011(1)(f), Florida Administrative Code. PBGMC is an Intervenor in opposition to St. Mary's application in DOAH Case No. 86- 4368 alleging that due to the service area and medical staff overlaps between St. Mary's and PBGMC, there will be adverse staffing, economic, availability and quality impacts upon PBGMC.


  5. Florida Hospital is an existing general acute care hospital in Service District 7, Orlando Florida, which has in place an open heart surgery program. It is subject to regulation pursuant to Sections 381.493-499, Florida Statutes (1985), and regulations promulgated thereunder, including Section 10- 5.011(1)(f), Florida Administrative Code. It may be inferred that a determination of invalidity of the Rule wall impact upon Florida Hospital if, as a result thereof CONs are granted for other open heart surgery programs in that

    District, but there is no direct evidence to that effect. No direct threat of revocation of Florida Hospital's existing CON or of economic or other impact of this rule challenge upon Florida Hospital was demonstrated by Florida Hospital at formal hearing.


  6. Respondent, HRS, is responsible for the administration of Sections 381.493-499, Florida Statutes, (the CON statute) and Chapter 10-5, Florida Administrative Code, (the CON rules).


  7. The initial development of the Rule was undertaken in 1982 and 1983 in a manner consistent with HRS internal policy. HRS reviewed the relevant literature relating to open heart surgery programs and services. Included among the literature reviewed were the National Guidelines for Health Planning (National Guidelines or Guidelines) and the standards for review of applications for certificates of need (CON) for open heart surgery services proposed by several Health Systems Agencies. At the time those standards were developed, the Health Systems Agencies were responsible for the first level of review in the state certificate of need process.


  8. Originally, the companion to the open-heart surgery rule, was Rule 10- 5.011(15), now codified as Rule 10-5.011(1)(e), Florida Administrative Code, which rule sets forth criteria for cardiac catheterization lab CON applications. Considerably more emphasis was accorded the development of the companion rule initially, but even expert witnesses for Petitioner's view acknowledge that the rule promulgation process relative to the adoption of the open heart surgery rule was thorough, rational, and essentially non-remarkable in the scope of promulgation of numerous CON rules drafted and implemented for the first time during a period in which HRS was also developing other rules dealing with a broad range of services and facilities to comply with new legislation eliminating Health Systems Agencies and requiring HRS to adopt uniform methodologies to be used in the CON program.


  9. Subsequent to its review of the literature, HRS formed a work group to assist in the development of the Rule.


  10. HRS prepared a draft of the proposed Ruled which was sent to over fifty experts in the field of cardiology. HRS received extensive comments on the draft rule. The final proposed Rule was published in the Florida Administrative Weekly. A public hearing on the proposed Rule was held in December, 1982, during which extensive public comment was received. The public comments were reviewed by and discussed among the HRS' health planning staff and administration. Upon consideration of all the input received, the final draft of the initial rule abandoned a proposal to rely on 1979 utilization data and substituted 1981 data. Additionally, provision was made to allow for consideration within the Rule's need formula of approved, but not yet operational, open heart surgery programs. The Rule was then filed for adoption and went into effect February 14, 1983.


  11. Because it was deemed prudent, and because the National Guidelines provided for it, HRS intended, at the time the initial open heart surgery rule was promulgated, to revisit the components of the Rule every 2-3 years.


  12. The Rule was next amended in 1986. At that time, in response to public comment, "Uc" of Subparagraph 8 of the Rule, which prescribes the base period to be used in the calculation of a service area use rate, was substantially revised. In its initial form, element "Uc" was based on the 1981 service area actual use rate. As amended, "Uc" measures the actual use rate in

    the service area for a 12 month period beginning 14 months prior to the letter of intent deadline for the batching cycle at issue, or the most recent use rate available to HRS. There have been no other substantial amendments which impinge upon the instant Rule challenge.


  13. Among other allegations, Petitioner asserts that because the Rule is silent as to which or however many exceptional circumstances would have to exist in order to justify approval of a CON application for an open heart surgery program in the absence of numerical needs the Rule is arbitrary and capricious. The evidence and applicable case law do not support such a premise. The Rule provides that HRS will consider applications in the context of applicable statutory and rule criteria. See 10-5.011(1)(f)2. The Rule further provides that HRS will "not normally" approve applications for new open heart surgery programs unless the conditions of subparagraphs 8 and 11 of the Rule are met. Also 10-5.011(1)(f)2. The very nature of "not normal" circumstances is that all possible "not normal" circumstances cannot be enumerated within a rule because in the attempt, some exceptionalities would inevitably be excluded. Of the four applications proposing new open heart surgery programs which have been approved in the recent past, three were approved under "not normal" circumstances, that is, where one or both provisions of Subparagraphs 8 and 11 were not met. The applicable state agency action reports (SAARS) which reflect HRS' preliminary position on CON applications, demonstrate that HRS routinely considers all relevant statutory and regulatory criteria in its review of open heart surgery program CON applications. There is no competent substantial evidence to show that HRS' evaluation of applications proposing new open heart surgery programs are prohibited by the Rule from entailing a balanced consideration of the statutory and regulatory criteria relevant to CON review.


  14. As a corollary of the foregoing allegation, it is alleged that because the Rule does not specifically address what has come to be known in CON practice as "the in-migration/out-migration" phenomenon, while at least one other CON rule does specifically address this phenomenon, a balanced consideration of all statutory criteria is frustrated, thereby resulting in understating the need for open heart surgery programs in one District/service area while enabling unnecessary, costly duplication of programs within other Districts/service areas. The use rate (discussed infra) purports to capture that in- and out- migration which can be standardized within the 12 month base period. At hearing, it was tenuously demonstrated that an unmeasured in-/out-migration phenomenon may exist within 2 out of 11 HRS Districts, but the degree to which it exists, if at all, is purely speculative. Even if these two Districts clearly possessed extraordinary timeframe, geographical, or transportation uniqueness, these access abnormalities would not justify declaring the Rule invalid. Rather, in the event the use rate for some reason does not measure them, these exceptionalities would be just the sort of "not normal" aberration for which it would be appropriate to resort to balancing of all statutory and rule criteria.


  15. Petitioner also contends that because this Rule does not define "service area" as the respective HRS Service District, it leaves each applicant free to designate, virtually at will, its own service area. Apparently, the initial Rule drafters intended that the service area be defined in the open heart surgery Rule as the HRS Service District. In finalizing Section (1)(e)(its companion cardiac catheterization lab rate rule), this definition was indeed included. However, in the open heart surgery rule, it was omitted. No witness recommended or even seriously considered that any service area less than the relevant HRS District should be designated, and the evidence is unrefuted and substantial that District lines have always been uniformly applied by HRS in

    interpreting the open heart surgery Rule. This interpretation is consistent with the agency's application of similarly silent rules.


  16. Petitioner alleges that because there is no Rule requirement or uniform manner for hospitals to report their open heart surgery utilization data to Local Health Councils or to HRS, the Rule is arbitrary and capricious. Authorized HRS representatives and others testified that data for the most current 12-month period, with a 2 month lag time are the most appropriate data to use. Testimony by St. Mary's experts that the data necessary to derive the rule methodology is not available, was directly refuted by evidence from authorized HRS representatives and others that HRS is able to collect all necessary data even though some councils report at different intervals from each other, and even though some hospitals report in "cases," others in "procedures" and one in "minutes." Because of these procedures of reporting, it may be necessary to make certain mathematical conversions or interpretations in preparing an agency SAAR or in presenting evidentiary proof in a Section 120.57 hearing, but even if one accepts that it is difficult to collect and interpret the necessary data, that concept does not support the conclusion that the Rule itself is arbitrary, capricious, or otherwise fatally flawed.


  17. Subparagraph 8 of the Rule defines Year X as the year in which the proposed open heart surgery program would initiate service but no more than two years into the future. St. Mary's contentions with regard to this provision are that the triggerpoint cannot be determined and that by allowing applicants in the same batching cycle to elect varying dates of initiating service, similarly batched applicants may select different horizons within the two year outside limit and therefore those two applicants could not be comparatively reviewed.

    It was shown that in the last batching cycle all applications were reviewed from the same trigger date and that HRS' implementation of the CON rules is guided by legal precedent. HRS' shifting of trigger dates in past batches is accounted for by shifting legal precedents. Therefore, assuming applicants in the same batch may unilaterally select different planning horizons within the traditional two year range permissible under the Rule, that is not sufficient to invalidate the Rule as arbitrary and capricious. The Rule establishes a need formula.

    Entitlement of applicants to "comparative review" is set forth in other statutory, ruled and case law authority. Applicants in the same batching cycle who elect significantly different horizon dates under the Rule probably ought not to be comparatively reviewed, but that problem is to be addressed within the context of "all statutory and rule criteria" both at the agency level in the case of initial review, and, when necessary, in the case of litigation before the Division of Administrative Hearings, by appropriate motion.


  18. The remainder of Petitioner's challenge addresses, in one form or another, the Rule's numerical need formula. The Rule establishes three thresholds which apply to utilization of open heart surgery programs. Subsection 3.d. requires that each program shall be able to provide 500 open heart operations per year." Each program is required to provide a minimum of

    200 adult open heart procedures annually within 3 years of the initiation of service, with no additional programs to be approved in a service area until each existing program is operating at a minimum of 350 adult open heart cases. Subparagraphs 8 and 11 are the cornerstones of the numerical need formula provided in the Rule.


  19. Specifically, Subparagraph 11 of the Rule provides:


    There shall be no additional open heart surgery programs established unless;

    1. The service volume of each existing and approved open heart surgery program within the service area is operating at and is expected to continue to operate at a minimum of 350 adult open heart surgery cases per year or 130 pediatric heart cases per year; and,


    2. The conditions specified in Sub- subparagraph 5.d., above, will be met by the proposed program.


      b. No additional open heart surgery programs shall be approved which would reduce the volume of existing open heart surgery facilities below 350 open heart procedures annually for adults and 130 pediatric heart procedures annually, 75 of which are open heart.


  20. The standard found at Subparagraph 11 of the Ruled which provides that there should be no additional open heart surgery units initiated in a service area unless each existing and approved unit is operating at and is expected to continue to operate at 350 adult open heart surgery cases per year or 130 pediatric open heart cases per year, is based upon a substantially similar standard enunciated in the National Guidelines published in 1978 and in effect at the time the Rule was initially promulgated.


  21. The National Guidelines were developed by the Federal Department of Health Education and Welfare (HEW) pursuant to an extensive process of public consultation, including receipt of recommendations and comments for Health Systems Agencies (HSAs), State Health Planning and Development Agencies (SHPDAs) Statewide Health Coordinating Councils, associations representing various health care providers, and the National Council on Health Planning and Development.

    The federal process of promulgation encompassed over two years of consultation, public notices, public meetings, and related activities.


  22. There were strong incentives to SHPDAs to develop local standards consistent with the National Guidelines and the National Guidelines contain a provision which permitted HSAs and SHPDAs pursuant to detailed local analyses, to deviate from the standards contained in the National Guidelines. The Florida Rule deviates from the National Guidelines in that it does not require facilities which offer cardiac catheterization services to also offer open heart surgery service.


  23. Florida's rationale supporting the 350 standard in its Rule is that of the National Guidelines which assumes that each facility can provide an average of seven operations a weeks a schedule HEW judged to be feasible in most institutions which provide open heart surgery services. As a matter of health planning policy, HEW established the 350 standard in an effort to prevent duplication of costly services which are not fully utilized, both as to facility resources and manpower. This goal is reiterated in the 1985 Florida State Health Plan. Reasonableness of the 350 case requirement is supported by testimony regarding the purposes behind the hours of operation standards portion of the Rule. See 10-5.011(1)(f)4.b. That subparagraph mandates that open heart surgery programs be available for procedures 8 hours per days 5 days per weeks

    for a total of 40 available hours of surgery per week, and capable of rapid mobilization of the surgical and medical support team for emergencies 24 hours per day, 7 days per week. Since it is estimated that each open heart procedure requires an average of 4 hours of operating room time, including cleanup, and operations go forward 50 weeks per year, then each program can, over time, attain the goal of 500 annual open heart operations which is set in Subsection

    3.b. Considering both elective and unscheduled services, HRS arrived at a 75 percent of maximum as a reasonable utilization figure, and Petitioner has in no way refuted the reasonableness of these hours of operation requirements or of HRS' 75 percent figure for reasonable utilization.


  24. The 350 threshold figure is primarily intended to ensure an appropriate utilization level of every open heart surgery unit. In fact, the minimum quality standard is set forth in Subparagraph 5 of the Rule as "200" and is supported in reason and logic upon the facts set forth, infra. The 350 figure here is intended to result in greater efficiency which results in economic benefits to the hospital which may ultimately be passed on to patients. I accept Dr. Luft's expert opinion and analysis that the economic benefits of a

    350 threshold are derived primarily from clinical economies of scale which result from improved proficiencies in the provision of service rather than solely in the classic economy of scale of a greater division of fixed costs. One clinical economy of scale demonstrated by Dr. Luft is that shorter average lengths of hospital stay result from high volume facilities. The shorter lengths of stay translate into patient or third party payor dollars saved.


  25. Admittedly, the 350 standard also secondarily encompasses consideration of the relationship of the volume of open heart surgery services and patient mortality, thus peripherally impinging on the volume of a 200 minimum threshold for quality of care purposes. Except for one study by Dr. Sloan, the evidence consistently supports existence of a negative relationship between volume and outcome, e.g., facilities performing higher volumes of open heart surgery have lower mortality rates. Obvious empirical problems inherent in Dr. Sloan's study impair its credibility. In light of his deposition testimony concerning how his several studies were conducted and how empirical data was converted by him for use in those studies, and due to his superior education, training, and experience, I find more credible Dr. Luft's determination that hospitals which perform low volumes of open heart surgery, particularly with respect to coronary artery bypass graft surgery, have substantially higher mortality rates than hospitals performing higher volumes of such surgery. Moreover, those areas of analysis in which the opinions of these two health care economic experts, Dr. Luft and Dr. Sloan, are consistent with one another and with the other literature and experts in the field whom they each cite as accepted and relied upon by them, strongly suggest that Dr. Sloan's unusual conclusion that low volume hospitals more often fit his unique categorization of "low mortality" should not be relied upon for purposes of formulating, drafting, and promulgating standard rules.


  26. The 350 standard does not appear to have impeded either competition or quality of care. There is also no competent substantial evidence to establish that there are too few open heart surgery programs in Florida at this time. At present, no District/Service Area has fewer than two open heart surgery programs, and 8 of the 11 Districts have 3 or more programs. Although many individual programs fall below the 350 thresholds on average, open heart surgery programs in operation in Florida perform close to 350 cases per year apiece. Between 1985 and 1986 the percentage of Florida programs performing 350 or more cases annually climbed from 24 percent to 35 percent.

  27. Petitioner never directly attacked the 200 procedure standard for quality, however, some evidence was presented to show that a lesser figure could still uphold quality considerations. This evidence was neither substantial nor credible. In lieu of the 350 utilization threshold, a variety of possible optimal threshold numbers were suggested by Petitioner's expert witnesses, among them 130 (the same utilization figure as for pediatric cases), 150, and 200 (the same figure as presently used to insure adult quality of care). Even if the highest of these suggested figures were selected as a utilization standard, that is, 200 cases per year substituted for the 350 utilization standards a minimum additional 31 open heart surgery programs would be "needed" on a statewide basis. This would nearly double the current number. Assuming there would emerge therefrom a normal distribution of programs around the substituted 200 standard, there could be the result that half the State's programs would then be operating below 200 and half above 200, so that half the programs would operate below the 200 quality of care standard now in effect. Even assuming arguendo that Petitioner's expert, Mr. Schwartz, is correct that 72 percent of current programs meet or exceed the 200 procedure levels and that that 72 percent would remain constant, more than one quarter of the state's programs would be below the 200 quality of care level. This is clearly not a desirable health planning goal. Such a proliferation of straight numbers of programs would doubtless impact adversely on all existing approved providers' utilization, concomitantly forcing up individual consumer costs. The testimony is more credible that the improvement curve "flattens out" anywhere from 333 to 350, but even if one were to accept St. Mary's witnesses position that the improvement curve "bottoms out" (that is, utilization and quality optimums meet) at 200 open heart surgeries, there is evidence that there is still some minimal improvement in outcome (quality) in operations performed in hospitals exceeding the 200 figure. The

    350 standard reduces the number of institutions over which a given number of procedures is spread and in general will result in higher volume per hospital, reducing the likelihood that outcomes would be worse than they might be otherwise.


  28. To the extent that witnesses support the position that the 350 figure is not reasonably or rationally related to the CON statutes, is arbitrary, or is unduly restrictive of the initiation of new open heart surgery programs, their testimony is unpersuasive in light of the foregoing determinations with regard to the hours of operation standards, the National Guidelines, and the statutory goal to avoid proliferation of such programs at the expense of efficiency, economy, and quality.


  29. Subsection 8 of the Rule provides as follows:


    Need Determination. The need for open heart surgery programs in a service area shall be determined by computing the projected number of open heart surgical procedures in the service area. The following formula shall be used in this determination:


    Where:


    N = Number of open heart procedures projected for Year X;

    U = Actual use rate (number of procedures per hundred thousand population) in the service area for the 12 month period beginning 14 months prior to the Letter of Intent deadline for the batching cycle.


    P = Projected population in the service area in Year X; and,


    Year X = The year in which the proposed open heart surgery program

    would initiate service, but not more than two years into the future.


  30. Subparagraph 8 of the Rule provides a formula by which numerical need for open heart surgery programs within a service area may be calculated. The use rate therein is based upon the number of procedures per 100,000 population in the District/Service Area for the 12 month period beginning 14 months prior to the letter of intent deadline for the applicant. If a District does not have

    12 months' experience, the statewide use rate is used. This use rate is based upon the most recent utilization data available to HRS. The data necessary to calculate the use rate is accessible and available to HRS as set out supra.


  31. The base period employed in the calculation of the use rate is appropriate for use in the numerical need methodology. It provides the most current picture of utilization of open heart surgery services within each District/Service Area which the agency has been able to devise. The Rule's base period essentially provides what health planners describe as a "realistic" or "rolling" use rate. Such a component permits consideration of facility number increases and volume fluctuations within facilities within the District/Service Area. Increased number of facilities and volume increases and decreases within specific facilities are quickly reflected by such a use rate and may be quickly considered in projecting need for the future. Such reality based use rates are customarily employed by health planners in projecting need for new open heart surgery services.


  32. The use rate minimally approaches the differences in population utilization of open heart surgery facilities occurring across age differential groupings. Although there is some evidence that the use rate formula contained in the Rule is not optimal in providing accessibility where there occasionally is clustering of "aged aged" population centers or clustering of heart surgery optimal age groups, the evidence in favor of such a rolling use rate establishes that as a statewide rule component, it is reasonable, not arbitrary, and not capricious. No witness offered a more reasonable substitute base period and the agency is not required to promulgate an optimal one, merely a reasonable one.


  33. St. Mary's and BRCH's witnesses suggestion that the Rule is ambiguous for a discernible number need methodology is not substantiated by credible competent evidence, and is generally rejected. Ms. Stamm, testifying for Respondent, had trouble with applying basic arithmetic under stress but not with the methodology. Mr. Schwartz, on behalf of the Rule's opponents, had some difficulty in determining whether the 200 or 350 standard was the appropriate figure for need determination. No other witness experienced Mr. Schwartz' confusion. When called to work Subparagraph 8 calculations, all witnesses were

    in agreement as to the mechanics of the Rule. No witness, including those who attacked the Rule as facially inconsistent due to the Rule's use of undefined terms of "programs," "procedures," and "cases" and/or those who complained about difficulty of obtaining raw data for the base time period had any difficulty in applying the Rule's numerical need formula, and indeed, Mr. Rond testified that HRS' interpretation of the numerical need formula was the most straightforward interpretation (TR-115) and the way he would logically do it. (TR-98-100) Each witness who was asked to use the Rule's formula in order to determine numerical need, consistently offered the following approach: First Derive Nx, as provided in Subparagraph 8. (Nx is the number of open heart procedures projected for year X). Second: Divide Nx by 350 (from Subparagraph 11) to obtain the gross projected need. Third, subtract from the gross projected needs the numbers of existing and approved programs within the applicable district so as to obtain the net need.


  34. The Rule's provision for subtraction of approved as well as for subtraction of operating programs from gross need so as to determine net need was investigated and adopted in the rational approach to rule promulgation. This is an accepted health planning component utilized in numerous CON rules. For these reasons and for all of the foregoing reasons related to the value of retaining 350 utilization and 200 quality thresholds, this provision for subtracting approved facilities from the gross need is found neither arbitrary nor capricious.


  35. The evidence presented by St. Mary's and BRCH is insufficient to demonstrate that HRS has not, subject to evolving legal precedent, consistently used the formula's interpretation set forth in Finding of Fact 33, at least as modulated by universally accepted common mathematical principles such as rounding results to the nearest whole number and considering "not normal" circumstances in light of all statutory and rule criteria on a case by case basis. In any case, if the agency misapplies its own Rule, applicants have recourse to a Section 120.57 proceeding and misapplication is not cause to invalidate the rule applied.


  36. I also reject as speculative and not credible St. Mary's allegation that a "sinister" conspiracy among existing and authorized providers within a given District may unnaturally reduce a single facility below the 350 threshold in order to thwart new program applications. Mr. Rond and Mr. Schwartz also promoted the premise that this result might occur unintentionally as well. HRS has not interpreted the Rule in such a peculiar manner and has approved new programs in districts where individual existing programs were not performing at the 350 level.


  37. I specifically reject as not credible the testimony of the St. Mary's and BRCH's witnesses professing concern that persons applying the Rule may be confused about how to work the formula and whether or not the pediatric population within a service area or the 130 pediatric procedures are to be subtracted at some point. Px is defined in the Rule to mean "the projected population in the service area in Year X." The Rule's language is plain and unambiguous. Nothing in the language of the Rule suggests the "projected population in the service area" is intended to exclude the pediatric population. Petitioner offered evidence that in certain instances HRS has applied Px to include the pediatric population. This, on its face, is an erroneous application of the Rule but without more, will not invalidate the Rule itself. Should HRS fail to implement the Rule according to the plain meaning of its languages an affected party may contest that agency action in a Section 120.57 hearing. In the case of former HRS employees concerned with drafting,

    promulgating amending and/or applying the Rule over a period of several years, their credibility is impaired by their never attempting to correct the alleged flaws and by their expressed perception of the necessity for a rule challenge as a strategic litigation move in anticipation of St. Mary's contested CON action.


    CONCLUSIONS OF LAW


  38. The Division of Administrative Hearings has jurisdiction to hear this matter pursuant to Section 120.56, Florida Statutes.


  39. Petitioner, St. Mary's, and Intervenor, BRCH, have adequately demonstrated their substantial interest in the challenged rule.


  40. Ruling was reserved upon Petitioner's ore tenus motion to dismiss Intervenor JFK, PBGMC, and Florida Hospital and to strike their evidence for lack of standing to participate in this proceeding.


  41. To comply with the requirements of Section 120.56, Florida Statutes, it must be established that the challenged rule has a "real and immediate effect upon one's case as well as injury in fact," and that the injury asserted is "arguably within the zone of interest to be protected or regulated." All Risk Corporation of Florida v. State Department of Labor and Employment Security, Division of Workers' Compensation, 413 So.2d 1200, (Fla. 1st DCA 1982). The "injury in fact" suffered by a party must be specific, real, and immediate--not abstract, remote, tenuous, or speculative. See Department of Offender Rehabilitation v. Jerry, 353 So.2d 1230, 1235-36 (Fla. 1st DCA 1978), cert .den.

    359 So.2d 1215 (Fla. 1978), and Diaz v. Florida Department of Corrections, 9 FALR 2262 (March 26, 1978).


  42. Upon the foregoing findings of fact, Intervenor JFK and PBGMC have proven by a preponderance of the evidence that they have standing in this cause. Standing resides in JFK and PBGMC by virtue of their Intervenor statuses in DOAH Case No. 86-4368 and their being regulated by the challenged rule even if St. Francis Careunit v. HRS et al., DOAH Case No. 84-2918 (Final Order entered July 27, 1987), and cited by St. Mary's and BRCH, may be interpreted to limit standing based upon demonstrable overlaps and economic losses. Florida Hospital, as an existing provider governed by a rule of statewide application also has a substantial interest in maintaining the validity of that rule, and therefore is a substantially affected person with standing to intervene in support of the ruled Johnson v. Johnson Home Health Care, Inc. v. Department of Health and Rehabilitative Services, 7 FALR 449 (Florida Department of Health and Rehabilitative Services, 1983), affirmed 447 So.2d 301 (Fla. 1st DCA 1984). St. Mary's and BRCH's reliance on St. Francis Careunit is misplaced. That case involved standing in a pending CON action, not in a challenge to an existing rule of long standing.


  43. Therefore, the ore tenus motion to dismiss and strike is denied. It is noted that the motion to strike with regard to Florida Hospital is a nullity in that Florida Hospital offered no exhibits or witnesses solely of its own.


  44. St. Mary's filed its Petition for Administrative Determination of the Invalidity of a Rule (the "Petition") on June 24, 1987, pursuant to Section 120.56, Florida Statutes. Section 120.56(2), Florida Statutes requires that:


    [t]he petition seeking an administrative determination under this section ... shall state with particularity ...

    facts sufficient to show the invalidity of the rule. (Emphasis supplied)


    The Petition identified the following specific issues in support of its general allegation that Rule 10-5.011(1)(f), Florida Administrative Code, constitutes an invalid exercise of delegated legislative authority.


    Subsection 8 of the ... rule ... is an arbitrary and irrational means for

    insuring the availability of open heart services, ... the use rate employed in Subsection 8 fails to consider the impact on the district use rate of new open heart surgery programs which have not yet reached their mature operating capacity [and] results in an erroneously suppressed district need projection, and,


    Subsection 11 of the rule is arbitrary capricious; and irrational in that it prohibits the approval of new open heart surgery programs unless all existing and approved open heart surgery programs are performing a minimum of 350 adult open heart surgeries or 130 pediatric heart cases per year, [and] fails to make provision for mitigating or extenuating circumstances which would justify the approval of new programs in the absence of the required service volume at each existing and approved open heart surgery program.


  45. On July 13, 1987, St. Mary's filed its Amended Petition for Administrative Determination of the Invalidity of A Rule. The Amended Petition further narrowed the issues raised in support of St. Mary's challenge as follows:


    The minimum service volume ... appearing at subparagraph 11 ... is

    arbitrary, capricious and not reasonably related to the purpose of the Florida Health Facilities and Health Services Planning Act; and,


    The need determination appearing at subparagraph 8 fails to specify the mechanism for determining the number of programs needed in a given service area.


    Over the objection of HRS, the amendment of St. Mary's Petition was granted by Order dated July 24, 1987.


  46. At final hearing, St. Mary's presented opinion testimony in support of its position which involved other elements of Subparagraph 8 of the Rule as follows:

    The Px factor in subparagraph 8 of the rule is vague and ambiguous, and,


    The definition of Year X in subparagraph

    8 is vague and ambiguous.


  47. JFK moved, ore tenus to strike all testimony relating to the Px factor and the definition of Year X, alleging that these presented new issues not previously included among the issues raised in the Petition or Amended Petition. JFK's motion was denied. In denying the motion, the undersigned observed that the testimony related to the workings of Subparagraph 8 of the Rule, which subparagraph had been identified in the Amended Petition as a basis for invalidating the Rule.


  48. Subsequent to submittal of the parties' respective post-hearing proposed findings of facto HRS and JFK moved to strike various portions of St. Mary's and BRCH's joint proposal. Ruling on these motions was reserved for this final order and its appendix. There is no authority or precedent to strike proposed conclusions of law and JFK's motion to strike these is denied. Since the remainder of HRS' and JFK' motions address proposed findings of fact, these are ruled upon in the course of the specific rulings made pursuant to Section 120.59(2), Florida Statutes, contained in the appendix hereto.


  49. Pursuant to Section 381.494(8)(b), Florida Statutes, HRS is authorized to promulgate "rules and minimum standards for the issuance of certificates of need." In cases such as this, where an agency is granted broad rulemaking authority by statute," ... the validity of regulations promulgated thereunder will be sustained so long as they are reasonably related to the purposes of the enabling Legislation ..." Florida Beverage Corporation v. Wynne, 306 So.2d 200,

    202 (Fla. 1st DCA 1975). Among the legislative goals of the Health Facilities and Health Services Planning Act, section 381.494-.99, Florida Statutes, is the "... elimination of unnecessary duplication of health services ... " Section 381.493(2), Florida Statutes.


  50. One who attacks the validity of a rule on grounds of arbitrariness or capriciousness carries the burden of demonstrating by a preponderance of the evidence that the rule is not supported by fact or logic, was adopted without thought or reason, or is otherwise not based on competent, substantial evidence. Agrico Chemical Company v. State, Department of Environmental Regulation. 365 So.2d 769 (Fla. 1st DCA 1979); Jax Liquor's, Inc. v. Division of Alcoholic Beverages and Tobacco, et al., 388 So.2d 1306 (Fla. 1st DCA 1980); Grove Isle, Ltd. v. State, Department of Environmental Regulation, 454 So.2d 571 (Fla. 1st DCA 1984).


  51. Agencies are to be accorded wide discretion in the exercise of their lawful rulemaking authority. Florida Commission of Human Relations v. Human Development Centers 413 So.2d 1251 (Fla. 1st DCA 1982).


  52. Further, the agency's interpretation of a statute need not be the sole possible interpretation or even the most desirable one, it need only be within the range of possible interpretations. Department of Administration v. Nelson,

    424 So.2d 852 (Fla. 1st DCA 1982); Department of Professional Regulation, Board of Medical Examiners v. Durrani, 455 So.2d 215 (Fla. 1st DCA 1984); General Telephone Co. of Florida v. Florida Public Service Commissions 446 So.2d 1063, (Fla. 1984).

  53. In Department of Health and Rehabilitative Services v. Framat Realty,

    407 So.2d 238, 241-2 (Fla. 1st DCA 1981), the court expressed the rationale underlying the broad discretion afforded agencies in the promulgation of administrative rules:


    ... the APA plainly regards rules as the valuable end point in the agency's development of policy. Rules represent

    an agency's considered decision on issues left to the agency's decision by a substantive act of the legislature. If we are to regard seriously the incentives for rulemaking under the APA scheme, and if we are to credit the deliberative process that the legislature has prescribed for the development of agency policy, then surely an interpretative rule emerging from this process should be accorded a most weighty presumption of validity. Otherwise the elaborate statutory scheme, pressing for rulemaking and prescribing how it should be accomplished with maximum public and private participation, has no productive purpose, and it has become only a snare for agency action, a device for the evasion, avoidance, or postponement of effective agency action in its authorized field of responsibility.


    When as here an agency has responded to rulemaking incentives and has allowed affected parties to help formulate the rules they know will regulate them in the future, the judiciary must not, and we shall not overly restrict the range of an agency's interpretative power.

    Permissible interpretations of a statute must and will be sustained, though other interpretations are possible, and may even seem preferable accordingly to some views. If the rule binds too tightly to suit them [litigants] have their proper remedy in the representative and politically responsive branches, the legislative or executive, but not in the judiciary, nor in Section 120.56 rule challenge proceedings before a hearing officer.


  54. The overwhelming weight of credible evidence, even that provided by the challengers' witnesses, is that the rule promulgation process relative to the adoption and amendment of Rule 10-5.011(1)(f) was thorough, reasonable, and rational. Evidence given by these witnesses which St. Mary's construes as "contrary" is something more than enlightened hindsight. In the context of motivation for this rule challenge, it is more properly construed as "backtracking."

  55. The Rule has a basis in fact and logic, was adopted with thought and reason pursuant to accepted procedures, and is otherwise based upon competent substantial evidence. It does not fail to establish adequate standards for agency decision-making or vest unbridled discretion in the agency.


  56. It is noteworthy that the Rule at issue herein was developed pursuant to the same process and record of promulgation as its predecessor Rule 10- 5.11(16), which was found valid at least to the degree it relied upon the National Guidelines, in North Broward Hospital District v. Department of Health and Rehabilitative Services, DOAH Case No. 86-1186R, Final Order issued July 18, 1986, and much the same process and record of promulgation as its original companion, the cardiac catheterization rule which was also found valid in Humana Inc. v. Department of Health and Rehabilitative Services, 469 So.2d 889 (Fla. 1st DCA 1985).


  57. In North Broward it was determined that since the National Guidelines did not mandate a particular exception regarding open heart surgical teams utilizing more than one open heart surgery facility, the HRS rule's general provision for "not normal" cases would be sufficient to address such an exceptional circumstance.


  58. In Humana, an applicant seeking a certificate of need to establish cardiac catheterization services challenged the validity of Rule 10-5.11(15), Florida Administrative Code, (now codified as Rule 10-5.011(1)(e), Florida Administrative Code), which provided the methodology used by HRS to determine the need for new cardiac catheterization services. The Humana decision determined,


    ... should the formula methodology

    ... result in an underestimation of the need for additional services in an area, the applicant has the opportunity to demonstrate need by showing that existing facilities are unavailable or inaccessible, the quality of care in the service area is suffering from over- utilization, or by providing other information to illustrate the situation is not "normal" in that service area. (Id. at 891)


  59. The Rule at issue herein, as the rule in Humana, requires HRS to consider applications for CONs proposing new open heart surgery services in the context of all applicable statutory and regulatory criteria. The Rule provides further that HRS will "not normally" approve applications for new open heart surgery programs unless the numerical need methodology demonstrates need for additional services. See 10-5.011(1)(f)2. Considering identical language contained in former Rule 10-5.011(15), Humana held such language to be acceptable to assure that the "numerical factor does not rigidly control the granting or withholding of approval." Id. at 890, see also Humhosco, Inc. v. Department of Health and Rehabilitative Services, 476 So.2d 258,261 (Fla. 1st DCA 1985).


  60. Whether exceptional circumstances justify approval is a discretionary conclusion of law. Bayonet Point Regional Medical Center v. Department of Health and Rehabilitative Services, 8 FALR 4339, HRS Final Order, August 22,

    1986. In Federal Management Corp. v. Department of Health and Rehabilitative Services, 482 So.2d 475 (Fla. 1st DCA 1986) the court stated,


    The Department's determination that factors other than the numerical need projected by the rule do not reach the level of exceptional circumstances so as to justify deviation from the rule methodology is a conclusion of law and therefore a matter within the permissive range of agency discretion." Id. at 477.


  61. In these proceedings, Petitioner has suggested that the use rate employed in calculating numerical need under the Rule results in the underestimation of need in some areas, and the overestimation of need in other areas. As the language contained in subparagraph 2. has been held sufficient to assure that the numerical factor does not control the approval or denial of an application, the distinction between this argument and the similar argument advanced by Petitioner in Humana (that the use rate employed in the rule underestimates need) is of no significance.


  62. With the instant Rule as with the Rule in Humana, if the agency takes preliminary action to approve an application for a new open heart surgery program solely on the basis of numerical need, existing providers have the opportunity, under this Rule, to establish that there exists adequate capacity within an area to safely accommodate the projected demand for open heart surgery services without adding a new program, based on evaluation of the application pursuant to all applicable statutory criteria. Likewise, if the agency takes preliminary action to deny an application solely on the numerical need determination, the applicant has resort to a Section 120.57 hearing in which to demonstrate either misapplication of the formula or failure to consider all applicable statutory or rule criteria.


  63. The Humana court distinguished former Rule 10-5.11(14), which had been held invalid in Department of Health and Rehabilitative Services v. Johnson and Johnson Home Health Care, Inc., 447 So.2d 361 (Fla. 1st DCA 1984), and which has been cited by St. Mary's and BRHC herein. In Johnson and Johnson, the court was confronted with a rule which required that existing home health care providers in a service area provide an average of 300 visits per day before a certificate of need could be issued to a new provider (the "Rule of 300"). The Rule of 300 allowed for "exceptions" under which a certificate of need could be issued in the absence of meeting the 300 standard, however, the exceptions were determined to be uncertain in their meaning and therefore arbitrary. The record in Johnson and Johnson demonstrated that the Rule of 300 was designed to protect existing providers of home health services from competition, and did not demonstrate there existed a reasonable relationship between the numerical threshold and the public health, safety and welfare.


  64. Herein, there is clear, competent and substantial evidence that quality and efficiency coefficients are dependent upon the 350 threshold established by this Rule.


  65. There is sufficient clarity of this Rule in operation. It has been shown to relate directly to the statutory purpose of the enabling legislation and to be within the discretionary authority vested thereby in the agency.

  66. When Subparagraph 8 is read in conjunction with Subparagraph 11, the Rule provides adequate direction as to how the number of needed open heart surgery programs is to be determined.


  67. Despite any alleged vagueness, ambiguity, or facial inconsistency of terms, each witness asked to "operationalize" the Rule's quantitative need methodology did so identically, making the connection between Subparagraph 8 and

    11 as HRS normally applies it. Moreover, Subparagraph 2 of the Rule makes joint reference to Subparagraphs 8 and 11 providing that the "Department will not normally approve applications for new open heart surgery programs in any service area unless the conditions of Subparagraph 8 and 11 below are met." (Emphasis supplied). There is no persuasive evidence that pediatric population as defined in Subparagraph 9 or the utilization rate for pediatric open heart programs can cause confusion. No witness seriously considered it logical or straightforward to interpret the Rule so as to either subtract 130 pediatric cases from 350 or to subtract the pediatric population from the full population before working the numerical need formula. The Rule's language is plain and unambiguous. There is nothing in the language of the Rule to suggest that "projected population in the service area" is intended to exclude the pediatric population.


  68. "Year X" is defined to be "the year in which the proposed open heart surgery program would initiate service, but not more than two years into the future." The record reflects that the agency's implementation of its CON rules is guided by legal precedent. Accordingly, HRS' interpretation within its SAARs over a period of time so as to assess different trigger dates could be expected to fluctuate. At the present time, HRS has stabilized this concept and past applications or even misapplications of the Rule are no cause to invalidate this Rule. Given the existence of other provisions governing comparative review and the agency goal that applications be reviewed in the context of all applicable statutory and regulatory criteria, the definition of Year X with its variable horizon maximized at 2 years is no cause to invalidate this Rule.


  69. Since the Rule provides fair notice to affected parties of the method pursuant to which quantitative need is to be calculated, and does not require persons of common intelligence to guess at the Rule's meaning, the Rule is not impermissibly vague in that regard. Orlando Central Park, Inc., et al. v. South Florida Water Management District, 9 FALR 1305 (DOAH 1987); Barrow v. Holland, 125 So.2d 749 (Fla. 1960).


  70. It is axiomatic that words of common usage, when plain and unambiguous, should be used in their plain and ordinary sense. Pedersen v. Green, 105 So.2d 1 (Fla. 1958); American Bankers Life Assurance Company v. Williams, 212 So.2d 777 (Fla. 1st DCA 1968). This rule is applicable equally to statutes, Vocelle v. Knight Brothers Paper Company, 118 So.2d 664 (Fla. 1st DCA 1960) and administrative rules, Gar-Con Development, Inc. v. Department of Environmental Regulation, 468 So.2d 413,415; Boca Raton Artificial Kidney Centers Inc. v. Department of Health and Rehabilitative Services, 493 So.2d 1055. A statute or rule should be construed so as to give meaning to every word of the statute, and, if possible, to avoid going outside the text for aids to construction. Vocelle at page 667.


  71. Where there is the suggestion that incorrect numbers have been plugged into the numeric need formula either by data error or by failure to correctly translate "procedure" to "case" or "program," these elements are susceptible of proof in agency review or an evidentiary hearing.

  72. Should HRS fail to implement the Rule according to the plain meaning of the language contained therein, an affected party may contest agency action based upon such erroneous implementation in a formal administrative proceeding under Section 120.57, Florida Statutes.


  73. Should "not normal" circumstances exist those also are subject to review and litigation.


  74. HRS has adopted a rule which contains a uniform statewide methodology, to be applied on a district basis for reaching a determination of need within each respective district. The rule purports to constrain the addition of open heart surgery programs while assuring a sufficient number to meet the respective District's needs. The methodology may not be ideal and may be out of step with a particular school of health planning but that is not the test of rule validity. A procedure for amendment or recall of an agency rule exists under Section 120.54(5), Florida Statutes, wherein the burden on a rule's opponent is not so stringent as in this rule challenge pursuant to Section 120.56, Florida Statutes.


  75. A challenger who attacks the substance of an agency rule on grounds of arbitrariness or capriciousness under Section 120.56 carries the stringent burden of demonstrating by a preponderance of the evidence that the rule is not supported by facts or logic, was adopted without thought or reason, or is otherwise not based upon competent, substantial evidence. Agrico Chemical Co.

  1. State supra. St. Mary's and BRHC have failed to carry this stringent burden in this proceeding.


    FINAL ORDER


    Based upon the foregoing Findings of Fact and Conclusions of Law recited herein, it is ORDERED THAT


    Rule 10-5.11(1)(f), Florida Administrative Code, constitutes a valid exercise of delegated legislative authority.


    DONE and ORDERED this 13th day of November, 1987, at Tallahassee, Florida.


    ELLA JANE P. DAVIS, Hearing Officer Division of Administrative Hearings The Oakland Building

    2009 Apalachee Parkway

    Tallahassee, Florida 32399-1550

    (904) 488-9675


    Filed with the Clerk of the Division of Administrative Hearings this 13th day of November, 1987.


    APPENDIX TO FINAL ORDER, CASE NO. 87-2729RX


    The following constitute specific rulings pursuant to Section 120.59(2), Florida Statutes, upon the parties proposed findings of fact and, further, denial of JFK's and HRS' respective Motions to Strike:

    By way of further clarification and explication of the basis upon which certain proposed findings were accepted or rejected, attention is directed to the fact that the record is replete with opposing expert opinions on several issues respecting the reasonableness of the subject Rule and the reasonableness of the process by which the Rule was formulated. In resolving such conflicts I have for the most part found the evidence in support of the reasonableness of the Rule to be more persuasive. The record also contains factual information and expert opinions which I have rejected as subordinate or unnecessary in the disposition of this rule challenge proceeding because they relate primarily to how the subject Rule could or would be applied. While irrelevant to this proceeding, such evidence might prove to be relevant in the related proceedings under Section 120.57 which addresses the Petitioner's and challenging Intervenor's applications for CONs.


    St. Mary's and BRCH's joint proposed findings of fact (FOF):


    1. Covered in FOF 1.

    2. Covered in FOF 2.

    3. Covered in FOF 1 and 2.

    4. Covered in FOF 3.

    5. Covered in FOF 4.

    6. Covered in FOF 5.

    7. Covered in FOF 6.

    8. Unnecessary.

9-10. Except as unnecessary and subordinate, covered in FOF 7-10.

  1. Unnecessary.

  2. Except as unnecessary and subordinate, covered in FOF 8, 11, 12, and 20-23. Furthers the proposal that the National Guidelines for Health Planning are no longer in effect is rejected as (1) mere recitation of testimony (2) opinion testimony absent a proper predicate, (3) uncorroborated hearsay and not substantive evidence of the fact asserted, (4) refuted by other witnesses that the Guidelines have remained in effect since 1978, and (5) if accepted, arguendo the assertion still is not dispositive of the issue at bar, absent explanation of all other reasons why the Guidelines may have been abandoned or modified, particularly the status of federal standards for operating room hours.

13-14. Rejected as a mere recitation of the testimony and not supported by the record as a whole.

  1. Accepted but not dispositive of the issue at bar. Covered in Finding of Fact 16.

    16-18. Subsequent to submittal of the parties respective post hearing proposed findings of fact, HRS and JFK moved to strike various portions of St. Mary's and BRCH's joint proposals. Ruling on these motions was reserved for this final order and its appendix. The issues raised at paragraphs 16, 17, and

    18 of the Finding of Fact section of St. Mary's and BRCH's joint proposed order do not directly relate to the issues raised in the Petition and Amended Petition. Unlike the "Px" and "Year x" issues, the issues identified in proposals 16, 17, and 18 do not relate to any of the subparagraphs of the Rule spoken to in the Petition or Amended Petition. However, to the extent that vagueness may so permeate a rule as to render it arbitrary and capricious, and to the extent that these proposals address interaction of Subparagraphs 8 and 11 of the Rule they may be considered. Accordingly,

  2. JFK's and HRS' respective motions to strike this proposal are denied. The chart in proposal 16 is accepted as accurate. The conclusion drawn therefrom is rejected as not supported by the greater weight of the credible evidence as a whole and for the reasons given in Finding of Fact 16, 30, and 33, that these conversions may be subject to evidentiary proof.

  3. JFK's and HRS' respective motions to strike this proposal are denied. It is rejected as not supported by the record as a whole and as covered in FOF 16, 30, 33, and 37.

  4. JFK's and HRS' respective motions to strike this proposal are denied. It is rejected as covered in FOF IS and 33.

19-20. HRS' motion to strike these proposals is not well taken upon grounds of surprise and prejudice and is denied, however the proposals are rejected for the reasons set forth in FOF 13-14 and the conclusions of law.

21-22. Rejected as not supported by the record as a whole and for the reasons set forth in FOF 13-14.

  1. Covered in FOF 29.

  2. Rejected as not supported by the record as a whole and for the reasons set forth in FOF 16, 30, 33-37.

  3. Rejected as mere recitation of the testimony, and as not dispositive of the issue at bar. Although many of the inconsistencies recited were demonstrated, this has been a maturing rule which is now being consistently applied and Year X is susceptible of evidentiary evaluation under the "not normally" exception and under other provisions for comparative review. See FOF 17.

  4. HRS' motion to strike is not well taken upon grounds of surprise and

    prejudice and is denied. The proposal is accepted but not adopted because it is subordinate and unnecessary with regard to those sentences describing the mixed reportage and sequence of reportage. The conclusion drawn there from as to the rule is rejected as not supported in law and in fact, as covered in FOF 16 and Conclusions of Law.

  5. HRS' motion to strike is not well taken upon grounds of surprise and, prejudice and is denied. The proposal is rejected as not supported by the record as a whole as covered in FOF 16, 30, and 37 and the Conclusions of Law.

  6. Rejected as not supported by the record as a whole. Covered in FOF 7, 20-23.

  7. Rejected as merely reciting testimony and as not supported by the record as a whole as covered in FOF 7-12 and 22-23.

30-32. Rejected as not supported by the record as a whole as covered in FOF 18, 24-25, and 27-28.

  1. JFK's motion to strike is not well taken upon grounds of surprise and prejudice and is denied, but the proposal is rejected as mere recitation of testimony, as taken out of context, and as subordinate and not dispositive of the issue at bar.

  2. Accepted in part and rejected in part for the reasons set out in FOF

    24 and further rejected as not supported by the greater weight of the credible evidence as a whole as covered in FOF 34.

  3. Sentence 1 is rejected as argument and conclusionary and not a finding of fact. Sentences 2 and 3 are unnecessary and not dispositive of the issue at bar. Sentence 4 is rejected as not supported by the record as a whole. The concept of a pyramid of quality care reaching its zenith in teaching hospitals was generally accepted among the expert witnesses, however, the promulgation of the Rule and National Guidelines as well as witnesses' testimony infers that teaching hospitals' methods of operation may permit them to achieve different but compatible clinical economies of scale than those normally considered by the Rule. Further, classic economies of scale are not of highest priority at teaching hospitals.

  4. Rejected as not supported by the greater weight of the evidence as a whole. Covered in FOF 34 and 36.

  5. Rejected as covered in FOF 38.

HRS' Proposed Findings of Fact (FOF):


1-4 and 6. Subordinate, see FOF 7-12.

5. Covered in FOF 9.

  1. Covered in FOF 10.

  2. Unnecessary.

  3. Covered in FOF 7-12.

  4. Covered in FOF 10.

  5. Unnecessary.

  6. Covered in FOF 10.

  7. Unnecessary.

  8. Covered in FOF 12.

  9. Covered in Conclusions of Law.

  10. Covered in FOF 16 and 30.

  11. Covered in FOF 23-24, 27-28.

  12. Covered in FOF 24-25.

19-23. Covered in FOF 18 and 23.

  1. Cumulative.

  2. Except as unnecessary, covered in FOF 24-25, and 27.

  3. Covered in FOF 27.

  4. Unnecessary.

28-29. Covered in FOF 26.

  1. Unnecessary.

  2. Rejected as stated as an unproven corollary.

  3. Unnecessary. Also, heart disease and open heart surgeries cannot be so nearly compared.

  4. Covered in FOF 25.

  5. Covered in FOF 27.

  6. Cumulative.

  7. Unnecessary.

  8. Unnecessary.

  9. Cumulative and unnecessary.

  10. Covered in FOF 24.

  11. Covered in FOF 13-14.

  12. Covered in FOF 18 and 33.

42-43. Covered in FOF 33, and 35.

  1. Covered in FOF 13.

  2. Covered in the Conclusions of Law.


JFK and PBGC's joint proposed FOF:


  1. Except as subordinate and unnecessary, covered in FOF 1 and 37.

  2. Covered in FOF 3.

  3. Covered in FOF 4.

  4. Covered in FOF 2.

  5. Covered in FOF 5.

  6. Covered in introductory material.

  7. Covered in FOF 8 and the Conclusions of Law. 8-10. Covered in FOF 7-11.

  1. Covered in FOF 12.

  2. Covered in FOF 7 and 20.

  3. Covered in FOF 21.

14-15. Except as subordinate and unnecessary, covered in FOF 22.

  1. Covered in FOF 23.

  2. Cumulative.

18-19. Covered in FOF 13.

20-21. Unnecessary.

  1. Covered in FOF 13.

  2. The portions rejected are rejected as specifically covered in FOF 15 and as subordinate and unnecessary. Credibility is assessed throughout the FOF. Portions accepted are covered in FOF 16, 29-30.

  3. Except as unnecessary and subordinate, covered in FOF 31.

25-28. The first sentence of FOF 25 is unnecessary. The second sentence is covered in FOF 31. The remainder of the proposals are accepted in part as covered in FOF 13 and 14, and otherwise rejected as mere recitations of testimony, unproved conclusions, and as unnecessary.

  1. Covered FOF 32.

  2. Covered FOF 19.

  3. Covered in FOF 24.

  4. Covered in FOF 20.

  5. Except where rejected as subordinate, unnecessary or cumulative, covered in FOF 25.

34-36. Except as mere argument or recitation of testimony or otherwise unnecessary, covered in FOF 24-28.

37-38. Covered in FOF 23 and 28.

  1. Except as unnecessary and cumulative, covered in FOF 24-25.

  2. Covered in FOF 26.

41-42. Covered in FOF 33-37. Credibility assessments are addressed throughout the orders especially FOF 37.

  1. Covered in FOF 17.

  2. Covered in FOF 17 and 35.


Florida Hospital's PFOF:


  1. Covered in FOF 1.

  2. Covered in FOF 2.

  3. Covered in FOF 3.

  4. Covered in FOF 4.

  5. Covered in FOF 5.

  6. Covered in FOF 6.

7-9. Except as subordinate and unnecessary, covered in FOF 7-10.

  1. Covered in FOF 10 and 12.

  2. Covered in FOF 7-12.

  3. Unnecessary and cumulative.

  4. Covered in FOF 18.

  5. Covered in FOF 24, 25 and 27.

  6. Covered in FOF 24.

16-18. Unnecessary and cumulative except as set forth in FOF 24. 19-20. Except as unnecessary and cumulative, covered in FOF 22-23.

  1. Covered only as necessary in FOF 27, otherwise rejected.

  2. Cumulative and mere recitation of testimony.

  3. Rejected as mere recitation of testimony and argument.

  4. Covered in FOF 26 and 27.

  5. Accepted in part in FOF 26. Remainder rejected as stated as an unproved corollary.

26-27. Except as cumulative, covered in FOF 27.

  1. Covered in FOF 33-37.

  2. Except as covered in FOF 16 and 30, rejected as mere recitation of testimony.

  3. Except as subordinate and unnecessary, covered in FOF 17 and Conclusions of Law.

  4. It is accepted that 4.a. of the Rule provides discreet assessibility standard but the remainder of the proposal is rejected as mere recitation of testimony, unproved conclusions, and unnecessary.

  5. Covered in FOF 36.

33-37. Unnecessary or cumulative, credibility is intrinsically assessed within all FOF and specifically within certain FOF 35-37 and the Conclusions of Law as necessary.

38. Cumulative.


COPIES FURNISHED:


Gregory L. Coler, Secretary Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700


W. David Watkins, Esquire Post Office Box 6507

Tallahassee, Florida 32314-6507


Darrell Whites, Esquire Post Office Box 2174

Tallahassee, Florida 32316-2174


Lesley Mendelson, Esquire Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700


Robert A. Weiss, Esquire The Perkins House

118 North Gadsden Street Tallahassee, Florida 32302


Robert S. Cohen, Esquire John F. Gilroy, Esquire Post Office Box 10095 Tallahassee, Florida 32302


Robert T. Klingebeil, Esquire 1001 Avenida del Circo

Post Office Box 1596 Venice, Florida 34284


Liz Clouds Chief

Bureau of Administrative Code The Capitol - 1802 Tallahassee, Florida 32301


Carroll Webb, Executive Director Administrative Procedure Committee

120 Holland Building Tallahassee, Florida 32301

Sam Power, Clerk Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700


NOTICE OF RIGHT TO JUDICIAL REVIEW


A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW PURSUANT TO SECTION 120.68, FLORIDA STATUTES. REVIEW PROCEEDINGS ARE GOVERNED BY THE FLORIDA RULES OF APPELLATE PROCEDURE. SUCH PROCEEDINGS ARE COMMENCED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF THE DIVISION OF ADMINISTRATIVE HEARINGS AND A SECOND COPY, ACCOMPANIED BY FILING FEES PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL, FIRST DISTRICT, OR WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE PARTY RESIDES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.


Docket for Case No: 87-002729RX
Issue Date Proceedings
Nov. 13, 1987 Final Order (hearing held , 2013). CASE CLOSED.

Orders for Case No: 87-002729RX
Issue Date Document Summary
Nov. 13, 1987 DOAH Final Order Rule 10-5.011(1)(f) in house open heart surgery certificate of need is valid
Source:  Florida - Division of Administrative Hearings

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