STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

HILLSBOROUGH COUNTY HOSPITAL AUTHORITY, ) d/b/a THE TAMPA GENERAL HOSPITAL, )

)

Petitioner, )

)

vs. )

)

DEPARTMENT OF HEALTH AND )

REHABILITATIVE SERVICES, ) CASE NO. 94-6087RX

)

Respondent, )

and )

)

ST. JOSEPH'S HOSPITAL, INC. )

)

Intervenor. )

)

FINAL ORDER

Pursuant to notice, the Division of Administrative Hearings, by its designated Hearing Officer, William F. Quattlebaum, held a formal hearing in this case in Tampa, Florida on November 29-30, 1994 and in Tallahassee on December 1, 1994.

APPEARANCES

For Petitioner: Elizabeth McArthur, Esquire

Radey Hinkle Thomas & McArthur

101 North Monroe Street, Suite 1000 Post Office Drawer 11307 Tallahassee, Florida 32302

For Respondent: Robert P. Daniti, Esquire

Senior Attorney

Emergency Medical Services Department of Health and

Rehabilitative Services 1317 Winewood Boulevard

Tallahassee, Florida 32399-0700

For Intervenor Bruce D. Lamb, Esquire

Christopher J. Schulte, Esquire

201 East Kennedy Boulevard, Suite 1000 Tampa, Florida 33602

STATEMENT OF THE ISSUE

Whether certain forms incorporated by reference into the administrative rules of the Respondent constitute an invalid exercise of delegated legislative authority.

PRELIMINARY STATEMENT

On October 31, 1994, the Petitioner filed a Petition for Determination of Invalidity of Existing Rules. The petition challenges three forms available from the Respondent and provided to potential applicants seeking certification as state approved trauma centers. The rule challenge was consolidated with DOAH Case No. 94-3669, the Petitioner's challenge to the Respondent's consideration of the Intervenor's application for certification as a pediatric trauma center.

At the hearing, a total of twelve witnesses were presented by the parties.

In order to minimize the inconvenience to witnesses, the parties agreed to permit concurrent direct and cross examination of witnesses. The Petitioner had exhibits numbered 1-12, 14 and 17-19 admitted into evidence. The Respondent had exhibits numbered 1 and 3-4 admitted into evidence. The Intervenor had exhibits numbered 1-6 and 8-13 admitted into evidence. One joint exhibit was admitted.

The prehearing stipulation filed by the parties was admitted as a Hearing Officer's exhibit.

A transcript of the consolidated hearing was filed. The Petitioner filed a proposed final order for Case No. 94-6087RX and a separate proposed recommended order for Case No. 94-3669. The Respondent filed a combined proposed final order and proposed recommended order for the cases. The Intervenor filed a proposed recommended order for Case No. 94-3669. The proposed orders submitted for Case No. 94-6087RX were carefully considered in the preparation of this Final Order. The proposed findings of fact are ruled upon in the Appendix which is attached and hereby made a part of this Final Order.

FINDINGS OF FACT

1. Tampa General Hospital ("TGH" or "Petitioner") is a general acute care hospital in Tampa, Florida and is a verified Level I state-approved trauma center.

   
   

2. By definition, a Level I trauma center is required to include an adult trauma center and a pediatric trauma referral center.

   
   

3. The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with responsibility for certification of trauma centers in Florida.

   
   

4. St. Joseph's Hospital ("SJH" or "Intervenor") has filed an application for state approval as a pediatric trauma referral center which is the subject of a separate administrative challenge by TGH.

   
   

5. In the instant case, TGH challenges three DHRS forms incorporated by reference into the Florida Administrative Code and which are utilized by applicants seeking certification as state-approved trauma centers. Tampa General has standing to challenge the forms in this proceeding.

   
   

6. The three forms challenged by TGH in this case are HRS Form 1840, ("State-Approved Trauma Center Letter of Intent"), HRS Form 1721, ("Application for State-Approved Pediatric Trauma Referral Center"), and the portions of HRSP 150-9, which identify the "critical standards" which must be met by an applicant seeking to obtain approval as a provisional state approved pediatric trauma referral center. The three forms include reference dates of October 1991.

7. The forms were adopted as part of a rule promulgation effort prior to the 1992 Legislative session. Obviously the DHRS did not address the 1992 legislation in the 1991 rules.

   
   

8. In relevant part, the 1992 legislation added a requirement that, under conditions set forth in the statute, proposed trauma centers must be certified as consistent with local or regional trauma plans. The forms challenged by TGH fail to reference the requirement.

   
   

9. Section 395.4025(2)(a), Florida Statutes, requires submissions of letters of intent from hospitals seeking to become certified as state-approved trauma centers.

   
   

10. Section 395.4025(2)(a), Florida Statutes, further requires that "[i]n order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists." The statute states that the requirement is not applicable to hospitals which were provisional or verified trauma centers on January 1, 1992.

    
    

11. There are five local or regional trauma agencies in Florida which have been approved by the DHRS. Hillsborough County, where both the Petitioner and the Intervenor operate hospitals, has one of the five local trauma agencies.

    
    

12. Rule 10D-66.109(a), Florida Administrative Code provides that the department "shall accept a letter of intent, HRS Form 1840, October 91, State- Approved Trauma Care Center Letter of Intent, which is incorporated by reference and available from the department. "

    
    

13. The form letter of intent provided to applicants by the DHRS fails to reference the local plan consistency requirement or the conditions under which the requirement is applicable.

    
    

14. Section 395.4025(2)(a), Florida Statutes, relates only to letters of intent. It clearly indicates that the certification of local plan consistency is an issue to be addressed as part of the letter of intent filed by a provider.

    
    

15. The form letter of intent does not provide notice to the applicant that such certification may be required, either as part of the completed letter of intent or otherwise.

    
    

16. The omission of the certification requirement from the letter of intent form is misleading. It fails to indicate that a hospital should address the issue in its letter of intent. The form contravenes the statute.

    
    

17. TGH also challenges HRS Form 1721, October 91, ("Application for

    State-Approved Pediatric Trauma Referral Center",) and the portions of HRSP 150- 9, October 91, which identify the "critical standards" which must be met by an applicant.

    
    

18. Section 395.4025(2)(c), Florida Statutes, (1994 Supplement) provides as follows:

    
    

    In order to be considered by the department, applications from those hospitals seeking

    selection as state-approved trauma centers, including those current verified trauma centers which seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of deter- mining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has:

    1. Equipment and physical facilities necessary to provide trauma services.

    2. Personnel in sufficient numbers and with proper qualifications to provide trauma services.

    3. An effective quality assurance program.

    4. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This sub- paragraph applies to any hospital that is not

       a provisional or verified trauma center on January 1, 1992.

       
       

19. Rule 10D-66.109(c), Florida Administrative Code, requires that an applicant for licensure as a provisional state-approved pediatric trauma referral center must submit an application on HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center. The form is incorporated by reference in the rule.

    
    

20. HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center, fails to reference the local plan consistency issue or the conditions under which the requirement is applicable. However, the instructions to the form provide as follows:

    
    

    INSTRUCTIONS: To be eligible for approval as a SAPTRC, a hospital must complete this

    application and submit all requested information to the HRS, Office of EMS, for review. The

    following must be used to complete this application: HRS Pamphlet (HRSP) 150-9 entitled "State Approved Trauma Centers

    and State-Approved Pediatric Trauma Referral Center Approval Standards", Oct 91 (standards document), and the application requirements of Chapter 395, Florida Statutes (F.S.), and

    Chapter 10D-66, Florida Administrative Code (F.A.C.).

    
    

21. Following discussion of a three phase review process, the HRS Form 1721 instructions again state that "HRS Pamphlet (HRSP) 150-9, Oct 91, the application requirements of Chapter 395, F.S., and Chapter 10D-66, F.A.C., will be used as criteria for application review."

22. By reference to the statute and rules, the instructions to the application notify an applicant as to the requirements for certification. The failure of the actual application to specifically restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement.

    
    

23. As to the standards document in which the critical standards for provisional approval are set forth, rule 10D-66.109(d)2, Florida Administrative Code, provides as follows:

    
    

    The minimum standards for review for Provisional SAPTRCs are the following portions of HRSP 150-9, October 91;

    
    

    STANDARD

    
    

    1. Type of Hospital

    2. Surgery Department; Division; Services; Sections: A

    3. Surgical Specialties Availabilities: A 1, 2, 3 & 4

    1. Non-Surgical Specialties Availabilities: 1, 8 & 13

    2. Emergency Department (ED): A, B, D & H

    3. Operating Suite Special Requirements: A

    IX. Pediatric Intensive Care (P-ICU): A, C, 1

    XVI. Quality Management: A, B, C, D, & E

    
    

24. It is unnecessary to address each critical standard in this order. Essentially, they relate to the first three "critical elements" set forth as Section 395.4025(2)(c)1-3, Florida Statutes. However, review of the cited portions indicates that there is no reference within the cited sections of HRSP 150-9, October 91, which addresses the possible requirement of local trauma plan consistency certification.

    
    

25. The application processing framework set forth by the administrative rules indicates that local plan consistency is to be considered prior to the DHRS's commencement of provisional review.

    
    

26. Rule 10D-66.109(d), Florida Administrative Code, provides that "[a]fter considering the results of the local or regional trauma agency's recommendations, the department shall, by April 15, conduct a provisional review to determine completeness of the application and the hospital's compliance with the critical standards for provisional standards."

    
    

27. If, as the rule suggests, certification of local plan consistency is considered prior to commencement of provisional review, it would be duplicative to include the requirement in the technical critical standards set forth in the standards document. The failure of the standards document to restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement.

    CONCLUSIONS OF LAW

    
    

28. The Division of Administrative Hearings has jurisdiction over the parties to and subject matter of this proceeding. Section 120.56, Florida Statutes.

    
    

29. As set forth at section 120.52(8), Florida Statutes, a proposed or existing rule is an invalid exercise of delegated legislative authority if any one or more of the following apply:

    
    

    1. The agency has materially failed to follow the applicable rulemaking procedures set forth in s. 120.54;

    2. The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(7);

    3. The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(7);

    4. The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency; or

    5. The rule is arbitrary or capricious.

    
    

30. The burden of proof falls to the Petitioner to establish that the rule is an invalid exercise of delegated legislative authority. As set forth in TGH's Petition for Determination of Invalidity of Existing Rules, the Petitioner asserts that the omission of reference to the potential requirement for certification of local or regional trauma plan consistency from certain forms is an invalid attempt by the DHRS to delete the requirement and improperly modify the statute, and therefore is an invalid exercise of delegated legislative authority as defined at section 120.52(8)(c), Florida Statutes.

    
    

31. As to the letter of intent form, TGH has met the burden. Section 395.4025(2)(a), Florida Statutes, provides as follows:

    
    

    The department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming state-approved trauma centers. In order to be considered by the department, a hospital that operates within the geographic

    area of a local or regional trauma agency must certify that its intent to operate as a state- approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1. This paragraph does not apply to any hospital that is a provisional or verified trauma center on January 1, 1992. (emphasis supplied)

32. Rule 10D-66.109(a), Florida Administrative Code" provides that the department "shall accept a letter of intent, HRS Form 1840, October 91, State- Approved Trauma Care Center Letter of Intent, which is incorporated by reference and available from the department...." The form fails to indicate that the applicant should address the issue of consistency with an approved local trauma plan.

    
    

33. TGH asserts that the omission of the requirement from the form results in the improper deletion of the requirement and contravenes the statute. The DHRS asserts that the omission of the requirement from the form does not preclude an applicant from complying with the statute. The DHRS also asserts that because the requirement does not apply to all applicants, it need not be stated in the form. The DHRS position is not persuasive.

    
    

34. The referenced statute clearly indicates that the certification of local plan consistency is an issue to be addressed as part of the letter of intent filed by a provider. The failure of the agency's required form to require such information from the applicant contravenes the clear language of the statute. HRS Form 1840, October 91, is an invalid exercise of delegated legislative authority.

    
    

35. As to the application form, Rule 10D-66.109(c), Florida Administrative Code, requires that an applicant for licensure as a provisional state-approved pediatric trauma referral center must submit an application on HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center.

    The application form omits any specific reference to the local plan consistency requirement. TGH asserts that such failure improperly modifies the statute.

    The TGH position is not supported by the evidence.

    
    

36. Rule 10D-66.109(d), Florida Administrative Code, states that "[a]fter considering the results of the local or regional trauma agency's recommendations, the department shall, by April 15, conduct a provisional review to determine completeness of the application and the hospital's compliance with the critical standards for provisional standards." By statute, the written confirmation requirement is to be addressed as part of the letter of intent.

37. Section 395.4025(2)(c), Florida Statutes, provides as follows: In order to be considered by the department,

    applications from those hospitals seeking

    selection as state-approved trauma centers, including those current verified trauma centers which seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review

    of each application for the purpose of determining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center.

    This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has:

    1. Equipment and physical facilities necessary to provide trauma services.

    2. Personnel in sufficient numbers and with

       proper qualifications to provide trauma services.

    3. An effective quality assurance program.

    4. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This sub- paragraph applies to any hospital that is not

       a provisional or verified trauma center on January 1, 1992.

       
       

38. The statute does no more than require that the review include a determination that the applicant has submitted the written confirmation when such is required. Even this level of review appears somewhat unnecessary. Consideration of the review and approval framework set forth in the statute and rules indicates that further consideration of local plan consistency after the filing of the letter of intent is redundant. Further, the instructions to the application directly refer to the statute and rules wherein the consistency issue is identified. Failure to require that the issue be addressed in the application form does not modify the statute or delete the potential requirement.

    
    

39. As to the standards document in which the critical standards for provisional approval are set forth, the critical elements set forth at Rule 10D- 66.109(d)2, Florida Administrative Code, relate to the first three "critical elements" identified at Section 395.4025(2)(c)1-3, Florida Statutes. TGH again asserts that the omission is an improper attempt to modify the statute. The evidence does not support the assertion. Because certification of local plan consistency is required at the time the letter of intent is filed, it would be duplicative to again require certification as part of the application itself or to consider it as part of the "critical standards" which must be met for approval of an application.

FINAL ORDER

Based upon the foregoing findings of fact and conclusions of law, it is determined that HRS Form 1840, October 91, "State-Approved Trauma Care Center Letter of Intent" constitutes an invalid exercise of delegated legislative authority. It is further determined that HRS Form 1721, "Application for State- Approved Pediatric Trauma Referral Center", and the portions of HRSP 150-9 which identify "critical standards" related to approval of a Provisional State- Approved Pediatric Trauma Referral Center and which are referenced herein do not constitute an invalid exercise of delegated legislative authority.

DONE and ENTERED this 3rd day of March, 1995, in Tallahassee, Florida.

WILLIAM F. QUATTLEBAUM

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 3rd day of March, 1995.

APPENDIX TO FINAL ORDER, CASE NO. 94-6087RX

The following constitute rulings on proposed findings of facts submitted by the parties.

Petitioner Tampa General Hospital

The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows:

9. Rejected, unnecessary.

11. Rejected, unnecessary.

Respondent Department of Health and Rehabilitative Services

The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows:

6. Rejected as to reference to section 395.4025(2)(a), Florida Statutes, contrary to the evidence.

COPIES FURNISHED:

Elizabeth McArthur, Esquire Radey Hinkle Thomas & McArthur

101 N. Monroe Street, Suite 1000 Post Office Drawer 11307 Tallahassee, Florida 32302

Robert P. Daniti, Esquire Senior Attorney

Emergency Medical Services Department of Health and

Rehabilitative Services 1317 Winewood Blvd.

Tallahassee, Florida 32399-0700

Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire

201 East Kennedy Blvd., Suite 1000 Tampa, Florida 33602

Carroll Webb, Executive Director Administrative Procedure Committee

120 Holland Building Tallahassee, Florida 32399-1300

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: 94-006087RX

Orders for Case No: 94-006087RX