Judges: J. LAWRENCE JOHNSTON
Agency: Agency for Health Care Administration
Latest Update: May 30, 1986
Summary: There was no rule-need for open-heart surgery program (not enough procedures per program). Since catheterization is not allowed without open-heart program, there was a need for cardiac catheterization laboratory; grant both.
85-3569STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
BAYONET POINT REGIONAL )
MEDICAL CENTER, )
)
Petitioner, )
)
vs. ) Case No. 85-3569
)
DEPARTMENT OF HEALTH AND )
REHABILITATIVE SERVICES, )
)
Respondent. )
)
RECOMMENDED ORDER
The final hearing in this case was held in New Port Richey, Florida, on March 19 and 20, 1986, before duly-designated Hearing Officer J. Lawrence Johnston, with the Division of Administrative Hearings.
For Petitioner: Donna H. Stinson, Esquire
Moyle, Flanigan, Fitzgerald & Sheehan, P.A. The Perkins House, Suite 100
118 North Gadsden Street Tallahassee, Florida 32301
For Respondent: Bruce McKibben, Esquire
Assistant General Counsel Department of Health and
Rehabilitative Services 1323 Winewood Boulevard
Tallahassee, Florida 32399-0700
The issue is whether Respondent, Department of Health and Rehabilitative Services (HRS), should grant the portions of the application of Petitioner, Bayonet Point Regional Medical Center (Bayonet Point) Con Action No. 3083, for a certificate of need for a cardiac catheterization laboratory and open heart surgery.1
At final hearing, the parties stipulated that the only issues in dispute were the need for cardiac catheterization laboratory and open heart surgery services in Pasco County and the ability of Bayonet Point to staff to provide those services.
1
The parties stipulated that all other statutory and rule criteria have been "satisfied" by Bayonet Point and that no evidence need be presented on those criteria.
FINDINGS OF FACT
Petitioner, Bayonet Point Regional Medical Center, (Bayonet Point), has applied for a certificate of need in part for a cardiac catheterization laboratory and for open heart surgery. Bayonet Point is an existing hospital located in Hudson in the northwest corner of Pasco County, part of District V of Respondent, Department of Health and Rehabilitative Services (HRS). District V also includes Pinellas County. Hillsborough County, part of HRS District VI, is adjacent to District V. Hillsborough County is southeast of Pasco County and east of Pinellas County.
Bayonet Point has five board certified cardiologists on its staff. It also has the nursing and other support staff needed by those cardiologists. If a cardiac catheterization laboratory and open heart surgery is added at Bayonet Point, Bayonet Point will be able to attract the additional needed specialists and staff.
Under the rule methodology for determination of need for cardiac catheterization laboratories set out in Rule 10- 5.11(15)(1) through (o), Florida Administrative Code, there is no need for an additional cardiac catheterization laboratory in District V.
However, the rule methodology referred to in the immediately preceding paragraph incorporates 1981 cardiac catheterization use rates. The 1981 use rates are out of date and lower than actual use rates. Using actual 1985 use rates, the rule methodology would demonstrate a need for one additional cardiac catheterization laboratory in District V.
In addition, even the actual 1985 cardiac catheterization use rates do not include or account for substantial utilization of Hillsborough County cardiac catheterization laboratories by residents of Pasco County.
There is a need for at least one additional cardiac catheterization laboratory in District V by the year 1986.
The two existing cardiac catheterization laboratories in District V are both in Pinellas County. Within District V, there is a need for a cardiac catheterization laboratory in Pasco County.
New Port Richey is centrally located both in terms of geography and in terms of population within Pasco County. Hudson, being in the northwest corner of Pasco County, is not. Hudson does have better access to the eastern and northeastern portions of Pasco County because of better arterial road access. Hudson also is more accessible to southern portions of Hernando County, part of HRS District III, which also are within Bayonet Point's primary service area. Hernando County also is without a cardiac catheterization laboratory and the southern portion of Hernando County needs one too.
There is no need for additional open heart surgery services in District V under the rule methodology for determination of such need set forth in Rule 10-5.11(16), Florida Administrative Code. The rule methodology employs 1981 utilization rates which project an average of approximately 342 open heart surgery procedures per year in the three existing open heart surgery programs in District V in the year 1986. Using 1985 utilization rates, the average utilization drops to approximately 317 procedures per year. None of the three existing open heart surgery programs in District V are projected to do 350 or more open heart surgery procedures in 1986. The rule methodology requires that all existing open heart surgery programs must be projected to do 350 or more procedures per year in 1986 before an additional open heart surgery program can be approved.
There is no open heart surgery service available at Bayonet Point at this time, and there is currently no open heart surgery service within 30 minutes travel time from Bayonet Point by emergency vehicle under average travel conditions.
Approximately 1200 Pasco County residents per year are being sent out of District V for cardiac catheterization, mostly to Tampa General Hospital. It can be estimated that 300 of those patients also undergo open heart surgery.
CONCLUSIONS OF LAW
Respondent, Department of Health and Rehabilitative Services (HRS), has promulgated Rule 10-5.11(15), Florida Administrative Code, for cardiac catheterization laboratory certificate of need determination. The rule presumably is promulgated under Section 381.494(8)(b), Florida Statutes (1985), authorizing HRS to promulgate "rules and minimum standards for the issuance of certificates of need." Nonetheless, Rule 10- 5.11(15)(f), provides in pertinent part:
The Department will not normally approve applications for new cardiac catheterization
laboratories in any service area unless additional need is indicated, as calculated by the formula in paragraph (1) below, and unless the application satisfies the requirements set forth in paragraph (o) below. (Emphasis added.)
See also Humana, Inc., et al. v. Department of Health and Rehabilitative Services, 469 So.2d 889 (Fla. 1st DCA 1985); Final Order, Adventist Health Systems et al. v. Department of Health and Rehabilitative Services, 7 F.A.L.R. 3500 (HRS June 27, 1985); Final Order, South Sarasota County Memorial Hospital Ass'n, et. al. v. Department of Health and Rehabilitative Services, 7
F.A.L.R. 1345 (HRS February 12, 1985).
As indicated in the Findings of Fact, there is a need for an additional cardiac catheterization laboratory in District V, Pasco County, although no additional need is indicated under Rule 10-5.11(15)(1)-(o), Florida Administrative Code.
As indicated by the Findings of Fact, there was evidence that New Port Richey would be the best location for a cardiac catheterization laboratory within Pasco County. But there is no pending application for a cardiac catheterization laboratory in New Port Richey to be compared with Bayonet Point's application. The criteria found in Section 381 494(6)(c)4., Florida Statutes (1985), refer to existing facilities and services in the service district which may serve as alternatives to proposed facilities and services. Likewise, Section 381.494(6)(d)1., Florida Statutes (1985), refers to existing alternatives to a certificate of need proposal or at least alternatives that are available without the necessity for certificate of need review. Therefore, Bayonet Point's application for a cardiac catheterization laboratory cannot be denied because an application for one in New Port Richey would be preferable had such an application been made and reviewed in Bayonet Point's batching cycle.
Absent Bayonet Point's application for a certificate of need for a cardiac catheterization laboratory, there would be no showing of need for additional open heart surgery services in District V under Rule 10-5.11(16), Florida Administrative Code. Subparagraph (k) of the rule provides that there shall be no additional open heart surgery programs established unless 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 open heart surgery cases per year. Based on 1985 utilization data, only approximately 317 procedures per year are projected for 1986 in District V. (Outdated 1981 utilization statistics would result
in an average of approximately 342 cases per year.) None of the three existing open heart surgery programs in District V are projected to meet or exceed the 350 case minimum established by the rule.
However, similar to Rule 10-5.11(15)(f), Rule 10- 5.11(16)(b), Florida Administrative Code, provides in pertinent part:
The Department will not normally approve applications for new open heart surgery programs in any service area unless the conditions of (h) and (k), below, are met. (Emphasis added.)
Under Rule 10-5.11(15)(i)5., Florida Administrative Code, an application for a cardiac catheterization laboratory cannot be approved unless there is open heart surgery service within 30 minutes travel time by emergency vehicle under average travel conditions, and cardiac catheterization laboratories where coronary angioplasty is performed must be located in health care facilities which also provide open heart surgery. Therefore, the needed cardiac catheterization laboratory for which Bayonet Point has applied cannot be granted unless Bayonet Point's application for open heart surgery also is granted.
In this case, although the conditions of Rule 10- 5.11(16)(h) and (k), Florida Administrative Code, are not met, Bayonet Point's application for open heart surgery should be granted so that its application for a needed cardiac catheterization laboratory will be approvable under Rule 10- 5.11(15)(i)5., Florida Administrative Code. Meanwhile, due to the large number of open heart surgeries for Pasco County patients which have been and are now performed outside District V, the addition of open heart surgery at Bayonet Point would not be anticipated to significantly reduce the number of open heart surgery cases that will be performed at the existing District V facilities. (The impact on Tampa General Hospital and District VI utilization has not been made relevant to this proceeding by the stipulation of the parties.)
RECOMMENDATION
Based on the foregoing Findings Of Fact and Conclusions Of Law, it is recommended that Respondent, Department of Health and Rehabilitative Services, enter a final order granting the portions of the application of Petitioner, Bayonet Point Regional Medical Center, CON Action No. 3083, for a certificate of need for a cardiac catheterization laboratory and open heart surgery.
RECOMMENDED this 30th day of May, 1986, in Tallahassee, Florida.
J. LAWRENCE JOHNSTON Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32399
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 30th day of May, 1986.
ENDNOTE
1/ As part of its application in CON Action No. 3083, Bayonet Point also applied for a certificate of need for a linear accelerator and radiation therapy. Those portions of Bayonet Point's application were a part of this case and also scheduled for final hearing on March 19 and 20, 1986. However, the parties, informally disposed of those portions of the application under Section 120.57(3), Florida Statutes (1985), by HRS's stipulation to grant those portions of Bayonet Point's application. HRS's stipulation was confirmed on the record at the final hearing.
As part of its application in CON Action No. 3083, Bayonet Point also applied for additional hospital beds. That portion of the application is part of consolidated proceedings now pending before the Division of Administrative Hearings in the case entitled Land O'Lakes Hospital, Inc. vs. Dept. of Health and Rehabilitative Services, Et al., Case Nos. 84-1509, 84-1776 and 84-1900.
Finally, part of Bayonet Point's application in CON Action No. 3083 was for upgrading its CT scanner and adding ancillary and support services and was approved. The approval has not been challenged.
COPIES FURNISHED:
Donna H. Stinson, Esquire Moyle, Flanigan, Katz,
Fitzgerald & Sheehan, P.A. The Perkins House Suite 100
118 N. Gadsden Street Tallahassee, Florida 32301
Bruce McKibben, Esquire Assistant General Counsel Department of HRS
1323 Winewood Blvd.
Tallahassee, Florida 32301
William Page, Jr. Secretary
Department of Health and Rehabilitative Services
1323 Winewood Boulevard
Tallahassee, Florida 32301 Nell Mitchem
CON Office
APPENDIX
The following are specific rulings on the parties' proposed findings of fact as required by Section 120.59(2), Florida Statutes (1985).
RULINGS ON PETITIONER'S PROPOSED FINDINGS OF FACT
The following Petitioner's proposed finding of fact are accepted as substantially factually accurate and are incorporated in the Findings Of Fact in the same or similar format to the extent necessary: 1, 2, 9, 12, 13, 18 and 21.
Petitioner's proposed finding of fact 3 would have been included in paragraph 1 above except that the second sentence is contrary to the greater weight of the evidence.
Petitioner's proposed findings of fact 4, 5, 6, 14-17 and 20 would have been included in paragraph 1 above except that they are unnecessary.
Petitioner's proposed finding of fact 7 is in part accepted and in part unnecessary.
Petitioner's proposed finding of fact 8 would have been included in paragraph 1 above except that the second and third sentences are unnecessary.
Petitioner's proposed finding of fact 10 would have been included in paragraph 1 above except that the last sentence was not proved and the rest is unnecessary.
Petitioner's proposed finding of fact 11 would have been included in paragraph 1 above except that all but the first sentence is irrelevant.
Petitioner's proposed finding of fact 19 would have been included in paragraph 1 above except that it is subordinate to facts found in the Findings Of Fact.
RULINGS ON RESPONDENT'S PROPOSED FINDINGS OF FACT
Respondent's proposed findings of fact 11 and 15 are accepted as substantially factually accurate and are incorporated in the Findings Of Fact in the same or the similar format to the extent necessary.
Respondent's proposed findings of fact 4 and 17 would have been included in paragraph 1 above except that they are unnecessary.
Respondent's proposed findings of fact 8(a) would have been included in paragraph 1 above except that the second sentence is rejected because only some of the patients come from Hernando County, the third sentence is subordinate to facts found in the Findings Of Fact, and the last sentence is a conclusion of law.
Respondent's proposed findings of fact 8(b) would have been included in paragraph 1 above except that all but the first sentence is rejected as contrary to the greater weight of the evidence.
Respondent's proposed finding of fact 9 would have been included in paragraph 1 above except that the first clause after the colon is rejected as contrary to the greater weight of the evidence and/or Findings Of Fact and the next clause is a conclusion of law.
Respondent's proposed finding of fact 10 would have been included in paragraph 1 above except that the first sentence is a conclusion of law.
Respondent's proposed finding of fact 13 would have been included in paragraph 1 except that the second sentence is rejected as contrary to the greater weight of the evidence and/or Findings Of Fact and the third and fourth sentences are unnecessary.
Respondent's proposed findings of fact 1, 6, 7 and 12 are rejected as conclusions of law.
Respondent's proposed findings of fact 2 and 3 are rejected as unnecessary..
Respondent's proposed finding of fact 5 is rejected because the first sentence is a conclusion of law and the second sentence is contrary to the greater weight of the evidence and/or Findings of Fact.
Respondent's proposed finding of fact 14 is rejected as contrary to the greater weight of the evidence and/or Findings Of Fact.
Respondent's proposed finding of fact 16 is rejected because it is not a finding of fact but a recitation of conflicting evidence.
================================================================= AGENCY FINAL ORDER
=================================================================
STATE OF FLORIDA
DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES
BAYONET POINT REGIONAL MEDICAL CENTER,
Petitioner,
CASE NO. 85-3569
vs. CON NO. 3083
DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES,
Respondent.
/
FINAL ORDER
This cause came on before me for the purpose of issuing a final agency order. The Hearing Officer assigned by the Division of Administrative Hearings (DOAH) in the above-styled case submitted a Recommended Order to the Department of Health and Rehabilitative Services (HRS). A copy of that Recommended Order is attached hereto. Exceptions to the Recommended Order were filed by HRS.
RULING ON EXCEPTIONS
HRS's exceptions are denied in that the findings of fact objected to are supported by competent substantial evidence and are arguably relevant to the question of whether exceptional circumstances justify approval of the CON.
FINDINGS OF FACT
HRS adopts and incorporates by referring the findings of fact set forth in the recommended order with the exception of paragraph 6 wherein the hearing officer concludes there is need for an additional cardiac catheterization laboratory in HRS District V because this conclusion is in reality a conclusion of law. Humana Inc., d/b/a Cypress Community Hospital v. DHRS slip opinion dated April 16, 1986, case #84-2515 Fla. 4th DCA 1986); Federal Management Corp. v. DHRS 482 So2d 475 (Fla 1st DCA 86).
CONCLUSIONS OF LAW
Respondent, Department of Health and Rehabilitative Services (HRS), has promulgated Rule 10-5.11(15), Florida Administrative Code, for cardiac catheterization laboratory certificate of need determination. The rule was promulgated under Section 381.494(8)(b), Florida Statutes (1985), authorizing HRS to promulgate "rules and minimum standards for the issuance of certificate of need." Rule 10-5.11( 5)(f), provides in pertinent part:
The Department will not normally approve applications for new cardiac catheterization laboratories in any new service area unless additional need is indicated, as calculated by the formula in paragraph (1) below, and unless the application satisfies the requirements set forth in paragraph (o) below. (Emphasis added.)
There is no need for an additional cardiac catheterization laboratory in District V under Rule 10-5.11(15).
Similar to Rule 10-5.11(15)(f), Rule 10- 5.11(16)(b), Florida Administrative Code, provides in pertinent part:
The Department will not normally approve applications for new open heart surgery programs in any service area unless the conditions of (h) and (k), below, are met. (Emphasis added.)
Under Rule 10-5.11(15)(i)5., Florida Administrative Code, an application for a cardiac catheterization laboratory cannot be approved unless there is open heart surgery service within 30 minutes travel time by emergency vehicle under average travel conditions, and cardiac catheterization laboratories where coronary angioplasty is performed must be located in health care facilities which also provide open heart surgery.
Where the numerical need projections of Rules 10.5.11(15) and (16) indicate no need, a determination that there are no exceptional circumstances justifying approval is a conclusion of law and the determination is a matter within the sound discretion of HRS. Federal Manaqement Corp v. DHRS 482 So2d 475 (Fla 1st DCA 86).
There is no need for additional open heart services in District V under Rule 10-5.11(16), Florida Administrative Code.
Subparagraph (k) of the rule provides that there shall be no additional open heart surgery programs established unless 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 open heart surgery cases per year. Based on 1985 utilization data, only approximately 317 procedures per year are projected for 1986 in District V. (Outdated 1981 utilization statistics would result in an average of approximately 342 cases per year.) None of the three existing open heart surgery programs in District V are projected to meet or exceed the 350 case minimum established by the rule.
The hearing officer's recommendation that Petitioner's application for a cardiac catheterization laboratory be approved presumably rests on a finding of exceptional circumstances (under the "not normally" provision of the Rule). He then uses his recommendation for a cardiac catheterization laboratory as the exceptional circumstance justifying approval of open heart surgery services by Petitioner. In light of the hearing officer's finding that Petitioner was not best located to serve Pasco Co., and declining utilization of open heart services in District V, this "bootstrap" reasoning supporting the recommendations for approval is rejected. The minimum utilization rates prescribed by the Rules are intended to ensure proficient and cost effective delivery of cardiac catheterization laboratory and open heart services. There are no exceptional circumstances justifying approval of Petitioner's application to provide open heart surgery.
Because there is no existing of approved open heart surgery service within 30 minutes travel time as required by Rule 10-5.11(15)(i)(5), Petitioner's application to provide cardiac catheterization laboratory services cannot be approved.
Based upon the foregoing Findings of Fact and Conclusions of Law, it is adjudged that the application of Petitioner, Bayonet Point Regional Medical Center, CON Action No. 3083, for a certificate of need for a cardiac catheterization laboratory and open heart surgery is denied.
DONE and ORDERED this 22nd day of 1986, in Tallahassee, Florida.
WILLIAM J. PAGE
Secretary
A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED T0 JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF HRS, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER-TO BE REVIEWED.
COPIES FURNISHED:
Donna H. Stinson, Esquire Moyle, Flanigan, Katz,
Fitzgerald & Sheehan, P.A. The Perkins House Suite 100
118 N. Gadsden Street Tallahassee, Florida 32301
Bruce McKibben, Esquire Assistant General Counsel Department of Health and
Rehabilitative Services 1323 Winewood Blvd.
Building One, Room 407 Tallahassee, Florida 32399-0700
J. Lawrence Johnston Hearing Officer
Divison of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32301
Nell Mitchem CON Office
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that a copy of the foregoing was sent to the above-named people by U. S. Mail this 26th day of August, 1986.
R. S. Power, Agency Clerk Assistant General Counsel Department of Health and
Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407
Tallahassee, Florida 32399-0700 904/488-2381
Docket for Case No: 85-003569
Orders for Case No: 85-003569
| Issue Date |
Document |
Summary |
|
Aug. 26, 1986 |
Agency Final Order
|
|
|
May 30, 1986 |
Recommended Order
|
There was no rule-need for open-heart surgery program (not enough procedures per program). Since catheterization is not allowed without open-heart program, there was a need for cardiac catheterization laboratory; grant both.
|
