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. 94-3669

)

Respondent, )

and )

) ST. JOSEPH'S HOSPITAL, INC. )

)

Intervenor. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, William F. Quattlebaum, held a formal hearing in the above-styled 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 St. Joseph's Hospital, Inc.'s application for certification as a State Approved Pediatric Trauma Referral Center should be approved.

PRELIMINARY STATEMENT

On April 1, 1994, St. Joseph's Hospital, Inc., (SJH) submitted an application for certification as a State Approved Pediatric Trauma Referral Center (SAPTRC) to the Department of Health and Rehabilitative Services (DHRS). On May 31, 1994, the DHRS notified SJH that the application had been found acceptable and that SJH could begin operation as a "provisional" SAPTRC. On June 10, 1994, the Hillsborough County Hospital Authority d/b/a the Tampa General Hospital (TGH) filed a Petition for Formal Administrative Hearing challenging the provisional approval by the DHRS of the SJH application.

The petition was referred to the Division of Administrative Hearings which scheduled the formal proceeding. A related rule challenge, DOAH Case No. 94- 6087RX, was consolidated for hearing with the instant case and is the subject of a separate Final Order.

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 recommended order for Case No. 94-3669 and a separate proposed final order for Case No. 94-6087RX. 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 in Case No. 94-3669 were carefully considered in the preparation of this Recommended Order. The proposed findings of fact are ruled upon in the Appendix which is attached and hereby made a part of this Recommended Order.

FINDINGS OF FACT

1. The Hillsborough County Hospital Authority d/b/a Tampa General Hospital ("TGH" or "Petitioner") is a licensed general acute care hospital in Tampa, Florida and is a verified level I trauma center.

   
   

2. By definition, a level I trauma center is required to include an adult trauma center and a state-approved pediatric trauma referral center ("SAPTRC").

   
   

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

   
   

4. St. Joseph's Hospital ("SJH" or "Intervenor") is a licensed general acute care hospital in Tampa, Florida and is a verified level II trauma center. SJH was provisionally approved as a level II trauma center on May 1, 1991 and was verified on July 1, 1992.

   
   

5. A level II trauma center is not required to operate a SAPTRC.

   
   

6. By letter of August 17, 1993, the DHRS notified the chief executive officers for all Florida hospitals of next trauma center application review

   cycle. Pursuant to statute, letters of intent were due by October 1, 1993 for the referenced review cycle.

   
   

7. A letter of intent to apply for certification as a trauma center is an nonbinding expression of intent. Frequently a hospital files a letter of intent to become a trauma center but and then fails to file the application.

   
   

8. A hospital seeking trauma unit certification must submit a letter of intent by the October 1 preceding the April 1 application deadline. A letter of intent is only valid for the application review cycle for which it is submitted. A hospital which submits a letter of intent but does not file the subsequent application must submit another letter of intent in order to file an application in a later review cycle.

   
   

9. Pursuant to Section 395.4025(2)(a), Florida Statutes, 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 cited statute specifically provides that this requirement does not apply to any hospital that is certified as a provisional or verified trauma center on January 1, 1992.

   
   

10. A trauma agency ("agency") is a planning unit of one or more county governments which plans for the development of the trauma system in that county or multi-county region. The DHRS is charged with review and approval of all local trauma agencies, the trauma systems plans adopted by such agencies and annual updates and amendments to local trauma plans.

    
    

11. The Hillsborough County Trauma Agency ("HCTA"), is the DHRS-approved local trauma agency for Hillsborough County, Florida and is responsible for trauma service area #10.

    
    

12. The Petitioner asserts that the SJH application will increase the number of service area #10 trauma centers beyond the limit of two imposed by statute and rule. There are currently two trauma centers in Hillsborough County (service area #10) including the Petitioner and the Intervenor. The expansion of services proposed by SJH will not increase the number of trauma centers in service area #10. If SJH is awarded the certification, there will still be two trauma centers.

    
    

13. The trauma services plan submitted by the HCTA and approved by the DHRS does not expressly address whether or not any need exists for a second SAPTRC in service area #10. The 1990 amendment to the local plan references SJH's interest in operating a SAPTRC, but does not state whether need exists for a second SAPTRC.

    
    

14. By letter of intent dated September 23, 1993 and received by the DHRS on September 30, 1993, SJH filed notice of intent to apply for certification as a state approved pediatric trauma referral center.

    
    

15. By letter of October 14, 1993, the DHRS acknowledged receipt of SJH's letter of intent.

    
    

16. The SJH letter of intent does not certify that the SJH's planned pediatric trauma referral center was consistent with the local trauma agency's plan.

17. The failure of SJH to certify that the proposed SAPTRC is consistent with the local trauma agency plan is of no consequence. Section 395.4025(2)(a), Florida Statutes, specifically exempts any hospital that is certified as a provisional or verified trauma center on January 1, 1992.

    
    

18. SJH was provisionally approved as a level II trauma center on May 1, 1991. Consideration of whether the local plan indicates need for an additional SAPTRC or whether the SJH proposal is consistent with the local trauma plan is not required.

    
    

19. Until immediately prior to this case being heard, and despite the aforementioned exemption for some facilities, the DHRS required all hospitals located in areas where local or regional trauma agencies exist to submit some type of certification that the proposed trauma unit was consistent with the local plan. Since adoption of the 1992 statutory amendments, the DHRS has failed to appropriately apply the referenced exemption. Immediately preceding commencement of the hearing in this matter, the DHRS position was revised to reflect the exemption.

    
    

20. The SJH application for certification as a SAPTRC was filed with the DHRS on or before April 1, 1993.

    
    

21. On May 13, 1993, the DHRS notified SJH of certain omissions and requested additional information.

    
    

22. On May 19, 1993, SJH filed its response to the request for information. Thereafter, the DHRS performed a preliminary review of the application to determine whether SJH met the requirements for approval as a "provisional" SAPTRC.

    
    

23. Included in the information considered by the DHRS in evaluating the SJH application were documents submitted by representatives of the HCTA related to whether the SJH application was supported by the local agency and was consistent with the local trauma plan. The HCTA documents submitted are immaterial because, as previously addressed, SJH is exempted from the requirement related to local trauma plan consistency.

    
    

24. The DHRS determined that the SJH application met the required critical standards for provisional approval. The DHRS notified SJH of the provisional approval on May 31, 1994.

    
    

25. TGH challenged the DHRS determination that the SJH application met the critical standards.

    
    

26. A hospital which meets the "critical elements" set forth in statute may receive provisional approval as a SAPTRC. Section 395.4025(2)(c), Florida Statutes, provides as follows:

    
    

    ....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 subparagraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992.

       
       

27. As previously stated, because SJH was a provisionally approved trauma center on January 1, 1992, it is not required to submit written confirmation by the local or regional trauma agency that verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency.

    
    

28. The parties stipulated that the SJH application meets the standards regarding staffing, facilities, equipment, and quality assurance required for provisional approval, except as to the following:

    
    

    1. Whether St. Joseph's will have adequate surgeon coverage and support to meet the require- ments to be a provisional SAPTRC.

    2. Whether St. Joseph's will have adequate physician coverage in its pediatric ICU to meet the requirements to be a provisional SAPTRC.

    3. Whether St. Joseph's meets the statute and rule requirements for provisional review as they relate to quality of care to pediatric trauma alert patients.

    
    

29. There was attention directed at the hearing to the fact that the DHRS application form fails to accurately track the applicable rules setting forth the requirements for certification as a SAPTRC. Notwithstanding the agency's failure to create an accurate application form, the minimum standards for review for Provisional SAPTRCs as identified in Rule 10D-66.109(d)2, Florida Administrative Code, 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

30. The booklet identified as "State-Approved Trauma Center and State- Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91" provides specific information related to each standard. The following constitutes review of the minimum standards for Provisional SAPTRCs as related to the application submitted by SJH.

    
    

    Standard I. Type of Hospital

    
    

31. SJH is a level II trauma facility and is a general acute care hospital with independent pediatric trauma patient care services within the facility, from emergency department admission through rehabilitation, separate and distinct from adult patient care services. SJH meets the Standard I requirement.

    
    

    Standard II. Surgery Department; Division; Services; Sections: A

    
    

32. SJH offers the required types of surgery, including general surgery, orthopedic surgery and neurosurgery. Orthopedic surgery and neurosurgery are divisions within the Department of Surgery. SJH meets the Standard II A requirement.

    
    

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

    
    

33. SJH meets the Standard III A requirement. SJH offers general surgery, neurosurgery, orthopedic surgery and otorhinolaryngologic surgery on call and promptly available 24 hours a day.

    
    

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

    
    

34. SJH meets the specified Standard V requirement. SJH offers the required types of non-surgical specialties, including anesthesia, pediatric intensive and critical care medicine, and radiology including diagnostic x-ray and computerized tomography. The specialists in each area have special competence in the care of the pediatric trauma patient in their specialties.

    
    

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

    
    

35. SJH meets the specified Standard VI A requirement. SJH has an identifiable intake and resuscitation area specifically equipped for pediatric trauma patients . The SJH pediatric trauma area is located in the Emergency Department and is easily accessible to land and air transportation.

    
    

36. SJH meets the specified Standard VI B requirement. SJH's Emergency Department has a designated medical director/physician for pediatrics, a trauma/general surgeon, emergency department physicians, a nursing staff and respiratory therapy staff. The personnel have special competence in the care of the pediatric trauma patients. SJH Emergency Department staff are available as follows: At least one E.D. physician is present in the E.D. 24 hours a day; Nursing staff is present in the E.D. 24 hours a day; and Respiratory therapy staff are on call and immediately available in-hospital 24 hours a day.

    
    

37. SJH meets the specified Standard VI D requirement. SJH has a radio communication system that conforms to the State EMS Communications Plan and telephone and paging equipment to contact trauma team members. The equipment is functional and is located in the trauma center intake area.

38. SJH meets the specified Standard VI H requirement. SJH has written protocols for the immediate response to the emergency department from the blood bank, laboratory, respiratory therapy and operating room.

    
    

    Standard VII. Operating Suite Special Requirements: A

    
    

39. SJH meets the specified Standard VII A requirement. SJH has a fully staffed and equipped operating room, available 24 hours a day for immediate use. Written operating procedures for 24 hour a day operating room availability for pediatric trauma patients and staffing are available for review by the DHRS.

    
    

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

    
    

40. SJH fails to comply with Standard IX as set forth in Rule 10D- 66.109(d)2, Florida Administrative Code, referencing "State-Approved Trauma Center and State-Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91." Standard A, C, 1 specifically requires that the P-ICU medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. SJH does not propose to place the P-ICU medical director or a physician designated by the P-ICU medical director in the unit 24 hours a day.

    
    

41. SJH proposes to make the P-ICU medical director or a physician designated by the P-ICU medical director available to the unit 24 hours a day. "Available to" the unit does not require that the identified employee be present in the hospital. As much as 30 minutes could pass before the P-ICU medical director or his designee arrives at the P-ICU.

    
    

42. Although the evidence establishes that the DHRS has accepted such arrangements in previous applications, the rule specifically requires that the referenced personnel be located in the P-ICU. There is no legal authority for the DHRS to disregard the requirement set forth in its own rules.

    
    

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

    
    

43. SJH meets the specified Standard XVI A requirement in that it has a comprehensive quality management plan in operation.

    
    

44. SJH meets the specified Standard XVI B requirement. SJH's quality management plan include protocols for 1) pediatric trauma patient triage and the issuance of an in-hospital trauma alert; 2) response of trauma team and documentation of response time in each patient record for members of the trauma team, neurosurgical, laboratory, x-ray, social work, pastoral, consultants and elapsed time for laboratory results. Protocols are also included related to trauma, medical and nursing staff patient care responsibilities, trauma operating room team response, assuring operating room and operating room staff availability to the pediatric trauma patient, pediatric trauma patient care in ICU, post-anesthetic recovery room and wards, transport of the pediatric trauma patient to the operating room, x-ray suites, CT scanner, ICU, and other hospital areas and hospital transfers.

    
    

45. SJH meets the specified Standard XVI C requirement. SJH plan includes, and SJH will implement and perform monthly trauma quality management, consisting of a trauma quality management committee that will meet at least monthly to review pediatric trauma cases, including cases involving morbidity and mortality.

46. The pediatric trauma service medical director or trauma nurse coordinator will review specified cases including all pediatric trauma alert cases, all critical admissions for traumatic injuries, all pediatric trauma Operating Room admissions from the emergency department and/or state-approved trauma center, any critical pediatric trauma transfers into or out of the emergency department and/or trauma center, and all traumatic deaths. Review of such cases will include application of "audit filters" as identified in the rule. Appropriate records will be maintained in-hospital, of all cases to which audit filters were applied.

    
    

47. Pediatric trauma cases will be evaluated by the medical director of the trauma service and/or trauma nurse coordinator. The trauma nurse coordinator and the medical director will present a summary of the reviewed cases not referred to the committee, along with cases requiring further evaluation where there is no clear and appropriate reason for a situation to have occurred.

    
    

48. Cases referred to the trauma quality management committee for which the committee can find no clear and appropriate reason for the situation to have occurred will be sent to appropriate persons or committees responsible for corrective action. The medical director of the trauma service will report back to the trauma quality assessment committee the resolution of each case.

    
    

49. The SJH trauma quality management committee is composed of the trauma nurse coordinator, a trauma surgeon (other than the pediatric trauma service medical director), an emergency physician, a surgical specialist (other than trauma surgeon), a representative from SJH administration, the operating room nursing director, the Emergency Department nursing director and the intensive care unit nursing director. At least 75 percent attendance of the committee members is required at the monthly trauma quality management committee meetings.

    
    

50. SJH will maintain minutes of all trauma quality management committee meetings for at least three years and are readily available for review by the DHRS. The minutes shall include at a minimum, the names of the attendees and the subject matter discussed, and actions toward resolution(s) of identified problems.

    
    

51. The trauma quality management committee will prepare and submit a quarterly report to the DHRS at the end of each calendar year quarter by the 15th of the month following the end of the previous quarter. The report will list every case selected for corrective action by the trauma quality management committee and will provide identify the hospital case number, the trauma registry number (from HRS Form 1728, "Trauma/Head Injury/Spinal Cord Injury Registry"), a description of questionable care, and the corrective action taken. If corrective action is not necessary, an explanation is required.

    
    

52. The medical director/chair of the trauma management committee will compile monthly statistics on each trauma surgeon on the trauma call roster. The statistics will be available for the DHRS review or will be submitted upon request. The statistics for each surgeon shall reflect the total number of cases per calendar month for which each trauma surgeon was notified to respond to a pediatric trauma alert and the total number of cases for which the trauma surgeon did not meet the pediatric trauma alert patient at the time of the trauma alert patient's arrival at the SAPTRC.

    
    

53. SJH will conduct a monthly multi-disciplinary trauma conference for case management and education. When appropriate, the conference will include

    review of the local/regional emergency medical service system, individual case management, the SAPTRC, solution of specific problems including organ procurement and donations, and trauma care education. The attendees will include representatives from trauma services, the emergency department, neurosurgery, orthopedics, nursing, social work, rehabilitation medicine, laboratory, x-ray, prehospital providers and hospital administration. At least

    50 percent attendance will be required at the monthly multi-disciplinary trauma conference. Minutes from these conferences, including the names of the attendees and subject matter discussed, will be maintained at the SAPTRC for a minimum of three years and will be readily available for review by the DHRS upon request.

    
    

54. SJH meets the specified Standard XVI D requirement relating to file maintenance. The trauma unit will have on file credentials of all surgeons in the trauma service as well as consultants, morbidity and mortality figures for the pediatric trauma service, CME data on all physicians participating in the pediatric trauma service, research and CME activities on all surgeons participating in the trauma services, nursing credentials, nursing CEU, any nursing research, a written plan of how the trauma nurse coordinator and the trauma service medical director's duties and responsibilities are integrated, a written disaster plan, the county or regional disaster plan and evidence of disaster drill activities.

    
    

55. SJH meets the specified Standard XVI E requirement relating to file maintenance. The SAPTRC will fully participate in the trauma registry

    
    

    CONCLUSIONS OF LAW

    
    

56. The Division of Administrative Hearings has jurisdiction over the parties to and subject matter of this proceeding. Section 120.57(1), Florida Statutes.

    
    

57. As the applicant, SJH has the burden of establishing by a preponderance of evidence that it is entitled to approval of its application for certification as a State Approved Pediatric Trauma Referral Center. Florida Department of Transportation v. JWC Company, Inc., 396 So.2d 778 (Fla. 1st DCA 1981).

    
    

58. Section 395.401(1), Florida Statutes, provides the following relevant definitions:

    
    

    1. "Level I trauma center means a hospital that is determined by the department to be in substantial compliance with trauma center and pediatric trauma referral center verification

       standards as established by rule of the department, and which:

       1. Has formal research and education programs for the enhancement of trauma care.

       2. Serves as a resource facility to Level II trauma centers, pediatric trauma referral centers, and community hospitals.

       3. Ensures an organized system of trauma care.

    2. "Level II trauma center" means a hospital that is determined by the department to be in substantial compliance with trauma center verifi- cation standards as established by rule of the

       department, and which:

       1. Serves as a resource facility to community hospitals.

       2. Ensures an organized system of trauma care.

    3. "Local trauma agency" means an agency established and operated by a county or an entity with which the county contracts for the purpose of administrative trauma services.

    4. "Pediatric trauma referral center" means

       a hospital that is determined to be in substantial compliance with pediatric trauma referral center standards as established by rule of the department.

    5. "Regional trauma agency" means an agency created and operated by two or more counties, or

       an agency with which two or more counties contract, for the purpose of administering trauma services.

    6. "State-approved trauma center" means a hospital that has successfully completed the state-approved selection process pursuant to s.395.4025 and has been approved by the depart- ment to operate as a trauma center in the state.

    
    

59. The DHRS is charged with developing a state trauma services plan. Local trauma agency plans are to be approved based on their consistency with the state plan. At hearing, TGH offered substantial evidence regarding the apparent failure of the DHRS to develop an appropriate state trauma services plan and the subsequent failure to provide adequate review of local plans prior to their adoption.

    
    

60. Such issues are outside the scope of this proceeding. The issue in this case is whether the SJH application meets the requirements of statute and rule and is therefore entitled to approval.

    
    

61. 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.

    
    

62. 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 subparagraph applies to any hospital that

       is not a provisional or verified trauma center on January 1, 1992.

       
       

63. The Petitioner asserts that SJH has failed to submit written confirmation by the Hillsborough County Trauma Agency that the verification of SJH as a state-approved trauma center is consistent with the plan of the HCTA. This requirement of written confirmation applies only to hospitals that were not provisional or verified trauma centers on January 1, 1992.

    
    

64. SJH was provisionally approved as a level II trauma center on May 1, 1991 and was verified on July 1, 1992. SJH is exempt from the requirement of written certification of local plan consistency.

    
    

65. Rule 10D-66.109(d)2, Florida Administrative Code, setting forth the critical elements for review, 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

    
    

66. The booklet identified as "State-Approved Trauma Center and State- Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91" provides specific information related to each standard as follows:

1. Type of Hospital

   
   

   A state-approved pediatric trauma referral center (SAPTRC) shall be located in a level I and may be located in a level II or pediatric hospital. A SAPTRC certificate may also be awarded to a general acute care hospital.

   General acute care hospitals with independent pediatric trauma patient care services within the facility, from emergency department admission through rehabilitation, separate

   and distinct from adult patient care services, will be permitted to apply to become stand alone SAPTRCs.

   
   

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

   
   

   1. A state-approved pediatric trauma referral center shall have the following surgical depart- ments; divisions; services; sections:

      1. general surgery;

      2. orthopedic surgery; and

      3. neurosurgery.

         
         

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

   
   

   1. The following surgical specialties shall be on call and promptly available, 24 hours a day:

      1. general surgery;

      2. neurosurgery;

      3. orthopedic surgery;

      4. otorhinolaryngologic surgery....

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

   
   

   The following non-surgical specialties shall be available at the state-approved pediatric trauma referral center. The specialists shall have special competence in the care of the pediatric trauma patient in their specialty.

   1. anesthesia;...

      8. pediatric intensive and critical care medicine;...

      13. radiology including diagnostic x-ray and computerized tomography.

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

   
   

   1. There shall be an easily identifiable intake and resuscitation area for pediatric trauma patients. This intake-resuscitation area may

      be part of the E.D. or it may be located within the trauma unit itself. The E.D. must also be easily accessible to land and air transportation.

   2. The emergency department shall be staffed with the following personnel:

   1. designated medical director;

   2. emergency department physicians with special competence in the care of the pediatric trauma patient. At least one E.D. physician shall be present in the E.D. 24 hours a day;

   3. nursing staff with special competence in the care of the pediatric trauma patient shall be present in the E.D. 24 hours a day; and

   4. respiratory therapy staff with special competence in the care of the pediatric trauma patient shall be on call and immediately available in-hospital 24 hours a day.

   D. The following communication equipment must

   be present and in working order in the intake area:

   1. radio communications system that conforms to the State EMS Communications Plan; and

   2. telephone and paging equipment to contact trauma team members.

   H. Written protocols for the immediate response to the emergency department from the blood bank, laboratory, respiratory therapy and operating

   room shall be required.

   
   

3. Operating Suite Special Requirements: A

A. A state-approved pediatric trauma referral center shall have one fully staffed and equipped operating room, available 24 hours a day for immediate use. Written operating procedures

for 24 hour a day operating room availability for pediatric trauma patients and staffing are required for department review.

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

   
   

   1. A pediatric ICU is mandatory for pediatric trauma patients.

1. The P-ICU shall be staffed with the following personnel:

   1. a designated physician medical director of the P-ICU or a pediatric intensive care

specialist. The medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day....

(emphasis supplied)

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

   
   

   1. A comprehensive quality management plan shall be available.

   2. The plan must include the following protocols for:

      1. pediatric trauma patient triage and the issuance of an in-hospital trauma alert;

      2. response of trauma team and documentation of response time in each patient record for;

         1. members of the trauma team;

         2. neurosurgical;

         3. laboratory;

         4. x-ray;

         5. social work, pastoral;

         6. consultants; and

         7. elapsed time for laboratory results;

      3. trauma, medical and nursing staff patient care responsibilities;

      4. trauma operating room team response;

      5. assuring operating room and operating room staff availability to the pediatric trauma patient;

      6. pediatric trauma patient care in ICU, post- anesthetic recovery room and wards;

      7. transport of the pediatric trauma patient to the operating room, x-ray suites, CT scanner, ICU, and other hospital areas; and

      8. hospital transfers.

   3. The plan shall also include, and the hospital will implement and perform, the following types of evaluations of trauma medical care:

      1. Monthly trauma quality management. There shall be a trauma quality management committee

         that will meet at least monthly to review pediatric trauma cases, including cases involving morbidity and mortality. The medical director of the trauma service shall chair the committee. The committee shall review all cases presented by the medical director or trauma nurse coordinator.

      2. The pediatric trauma service medical director or trauma nurse coordinator shall review and apply audit filters, as listed in 3., to the following cases:

         1. All pediatric trauma alert cases (whether identified by state trauma scorecard or local emergency medical services criteria);

         2. All critical admissions for traumatic injuries;

         3. All pediatric trauma OR admissions from the emergency department and/or state-approved trauma center (excluding same day discharges or isolated non-life threatening orthopedic injuries);

         4. Any critical (see definition) pediatric trauma transfers into or out of the emergency department and/or trauma center; and

         5. All traumatic deaths.

      3. Audit filters to be applied to cases identified in 2. include

         1. the general surgeon on trauma call did not meet the pediatric trauma alert patient upon the

            pediatric trauma alert patient's arrival at the SAPTRC

         2. a pediatric trauma alert patient with an emergency department admission systolic blood pressure less than 90mmHg.* and total time in the emergency department of over two hours from emergency department/trauma service admission

            to disposition (including radiology time);

            *This number may vary with pediatric age and normal vital sign ranges.

            
            

            INTERPRETATION: "Disposition" refers to a written decision for inpatient admission or discharge. It excludes those critical care admits that remain in the E.D. due ONLY to a lack of bed space or pediatric patients that may have a normal BP lower than 90 systolic.

            
            

         3. the number of intensive care unit (ICU) days for a pediatric trauma patient is greater than twice the average ICU days for pediatric trauma patients at the SAPTRC calculated by the SAPTRC or based upon Florida Trauma Registry data;

            
            

            INTERPRETATION: This average is based on your own state-approved trauma center's average ICU days.

            
            

         4. the neurosurgeon response time is greater than 30 minutes from the time of call-in request;

            
            

            INTERPRETATION: The response time is the arrival time of the neurosurgeon.

            
            

         5. a pediatric trauma patient admitted to a non-surgical service.

         6. a pediatric trauma patient unplanned return to the operating room within 48 hours;

         7. a pediatric trauma patient receiving initial abdominal, thoracic, vascular, or cranial surgery more than 24 hours after emergency department arrival;

         8. all complications;

            
            

            INTERPRETATIONS: Centers for Disease Control (CDC) defines complication as a condition arising after the injury that modifies the course of medical care required. A complication may result from an adverse reaction to treatment (a useful reference is CDC's list of complications).

            
            

         9. an absence of initial and hourly sequential documentation in emergency depart- ment record of physiologic measurements for a pediatric trauma patient from emergency department arrival until admission to the operating room, intensive care unit, transfer to another institution, or death, regardless of physical location of patient;

            INTERPRETATION: The hourly sequential documentation must be complete until there is a written disposition for the patient from the emergency department to OR, ICU, etc.

            
            

         10. a comatose (Glasgow Coma Scale (GCS) score

             8 and under]* pediatric trauma patient leaving the emergency department prior to establishment of a mechanical airway;

             * GCS will vary with pediatric age.

             
             

             INTERPRETATION: "Mechanical airway" includes inserted airway devises either nasal, oral, crichoid (rarely, if ever used in infant or small child), or tracheal.

             
             

         11. a pediatric trauma patient with an altered state of consciousness upon emergency department arrival, receiving initial head computerized tomography scan greater than 2 hours after emergency department arrival;

             
             

             INTERPRETATION: "Altered state of consciousness" refers to a GCS score of under

             1. GCS will vary with pediatric age.

                
                

         12. a pediatric trauma patient with a diagnosis of epidural or subdural brain hematoma receiving a craniotomy greater than 4 hours after emergency department arrival (excluding intracranial pressure monitoring);

         13. absence of initial and hourly sequential documentation in emergency department record of neurologic status evaluations for a pediatric trauma patient with a diagnosis of a skull fracture, intracranial injury or spinal cord injury;

             
             

             INTERPRETATION: "Neurological status" refers to your own institution's standards for neurological status evaluation, with GCS as a minimum. GCS will vary with pediatric age.

             
             

         14. a pediatric trauma patient with a discharge diagnosis of a cervical spine injury not indicated in admission diagnosis;

             
             

             INTERPRETATION: This audit filter is searching for missed cervical spine injuries.

             
             

         15. an interval of greater than 8 hours between emergency department arrival and

             initial operating room treatment for a pediatric trauma patient with open fractures resulting from blunt trauma;

         16. a pediatric trauma patient with a diagnosis of liver or splenic lacerations receiving a laparotomy greater than 2 hours from emergency department arrival (excludes patients who do not require surgery);

         17. a pediatric trauma patient with a gunshot wound or stab wound to the torso or neck who

             does not receive appropriate surgical intervention;

             
             

             INTERPRETATION: The definition of penetrating injury as defined for prehospital scorecard methodology does not include superficial wounds in which the depth of the wound can be easily determined.

             
             

         18. a pediatric trauma patient in a trans- ferring hospital more than 30 minutes prior to initiating a transfer to a SAPTRC; and

             
             

             INTERPRETATION: This audit filter refers to the patient that was compromised due to delay in care.

             
             

         19. an autopsy was not completed for a pediatric trauma death.

             1. A log shall be maintained in-hospital,

                of all cases to which audit filters were applied. The log must include the following at a minimum:

                date reviewed; discharge date; patient's name; medical record number;

                state trauma registry number; injury severity score (ISS); case criteria (C 2. a-e);

                applicable audit filters (C 3. a-s); reviewer's name;

                review disposition; and final disposition with date

                An in-hospital trauma registry may substitute for this log provided all required elements

                are included.

             2. The medical director of the trauma service and/or trauma nurse coordinator will evaluate

                all cases identified by applying the audit filters. If a case is identified by an audit filter(s) and the trauma nurse coordinator and medical director can find no clear and appropriate reason for the situation to have occurred, the case will be referred to the trauma quality management committee for further evaluation. The trauma nurse coordin- ator and the medical director will present a summary of the reviewed cases not referred to the committee, along with cases requiring further evaluation.

             3. Cases referred to the trauma quality manage- ment committee for which the committee can find

                no clear and appropriate reason for the situation

                to have occurred will be sent to appropriate persons or committees responsible for corrective action.

                The medical director of the trauma service shall be responsible for reporting back to the trauma quality assessment committee resolutions for each case.

             4. The trauma quality management committee

                shall be composed of at least the following persons;

                1. trauma nurse coordinator;

                2. trauma surgeon, other than the pediatric trauma service medical director;

                3. emergency physician;

                4. surgical specialist other than trauma surgeon;

                5. representative from administration;

                6. operating room nursing director or designee;

                7. emergency department nursing director or designee; and

                8. intensive care unit nursing director or designee (other suggested additions include: Neurosurgeon, Orthopedic surgeon, Pediatric surgeon, etc).

             5. There shall be at least 75 percent attendance of the above committee members (three must always be another representative from the trauma service in addition to the pediatric trauma service medical director) at the monthly trauma quality management committee meetings.

             6. Minutes of all trauma quality management committee meetings shall be maintained at the SAPTRC for at least three years and shall be ready available for review by the department upon request. The minutes shall include at a minimum, the names of the attendees and the subject matter discussed, and actions toward resolution(s) of identified problems.

             7. The trauma quality management committee shall prepare and submit a quarterly report to the department. The reports shall be submitted at the end of each calendar year quarter by the 15th of the month following the end of the previous quarter. The report shall list every case selected for corrective action by the trauma quality management committee (do not include information that would identify the

                patient) and shall provide the following regarding each case:

                1. hospital case number;

                2. trauma registry number from HRS Form

                   1728, "Trauma/Head Injury/Spinal Cord Injury Registry";

                3. description of questionable care; and,

                4. corrective action taken; if corrective

                   action is not necessary, an explanation is required.

             8. The medical director, as chairman of the trauma quality management committee, shall compile monthly statistics on each trauma surgeon on the trauma call roster. The medical director shall maintain the statistics such that they are readily available for department review, or submit them to the department upon request. It is not necessary that the medical director identify the surgeons by name to the department, but the medical director must know the surgeons through some identification system. The statistics for each surgeon shall reflect:

                1. total number of cases per calendar month for which the trauma surgeon was notified to respond to a pediatric trauma alert (level I, level II and SAPTRC); and

                2. total number of cases for which the trauma surgeon did not meet the pediatric trauma alert patient at the time of the trauma alert patient's arrival at the SATC or SAPTRC. (level I, level II and SAPTRC).

             9. Monthly multidisciplinary trauma conference.

                1. This conference shall be for case management and education. The conference shall include the review of the following where appropriate:

                   1. the emergency medical service system locally and regionally;

                   2. individual case management;

                   3. the SAPTRC or system;

                   4. solution of specific problems including organ procurement and donation; and

                   5. trauma care education.

                2. The attendees shall include a representative from the following:

                   1. trauma service;

                   2. emergency department;

                   3. neurosurgery;

                   4. orthopedics;

                   5. nursing;

                   6. social work;

                   7. rehabilitation medicine;

                   8. laboratory;

                   9. x-ray;

                   10. prehospital providers; and

                   11. hospital administration

                3. In addition, a chaplain and a representative from the medical examiner's (coroner's office) should be encouraged to attend the monthly trauma conference.

                4. There shall be at least 50 percent attendance of the above departments at the monthly multidisciplinary trauma conference.

                5. Minutes from these conferences shall be maintained at the SAPTRC for a minimum of

             three years and shall be readily available for review by the department upon request. These minutes shall include as a minimum, the names of the attendees and subject matter discussed.

             
             

             INTERPRETATION

             
             

             There shall be a mechanism in place for physicians to receive continuing medical education and nurses and paramedics to receive continuing education units from the trauma conference.

             
             

   4. The trauma component of the hospital shall have on file:

      1. credentials of all surgeons in the trauma service as well as consultants;

      2. morbidity and mortality figures for the pediatric trauma service;

      3. CME data on all physicians participating in the pediatric trauma service;

      4. research and CME activities on all surgeons participating in the trauma services;

      5. nursing credentials;

      6. nursing CEU;

      7. any nursing research;

      8. a written plan of how the trauma nurse coordinator and the trauma service medical

         director's duties and responsibilities are integrated;

      9. a written disaster plan;

      10. county or regional disaster plan; and

      11. evidence of "practice disaster" activities.

          
          

   5. The SAPTRC shall fully participate in the trauma registry as required in section 10D-66, Florida Administrative Code.

1. Other than minimum standard IX A, C, 1, SJH meets the minimum standards for certification.

   
   

2. As set forth in the findings of fact, SJH fails to meet minimum standard IX A, C, 1, related to the pediatric intensive care unit. The standard clearly requires that the P-ICU medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. SJH proposes to make the P-ICU medical director or a physician designated by the P- ICU medical director available to, but not in, the unit 24 hours a day. This arrangement does not meet the rule.

   
   

3. SJH and the DHRS assert that the DHRS has accepted such arrangements in previous applications and that it should be accepted in this case as well. The DHRS cites no legal authority which would permit an agency to disregard its own rules.

   
   

4. SJH suggests that even if the proposal is found lacking, the referenced statutes provide a period during which an applicant hospital may be required by the DHRS to supply additional information, correct omissions and rectify deficiencies in a proposal. SJH asserts that the application should be provisionally approved pending the provision of additional information to the agency.

   
   

5. In this case, the agency is not requesting additional information.

The DHRS has not indicated that a deficiency needs to be corrected. To the contrary, the DHRS has approved the application, not withstanding the failure of the proposal to comply with the agency's own rules.

RECOMMENDATION

Based upon the foregoing findings of fact and conclusions of law, it is hereby RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order denying the application of St. Joseph's Hospital for certification as a State-Approved Pediatric Trauma Referral Unit.

DONE and RECOMMENDED 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 RECOMMENDED ORDER, CASE NO. 94-3669

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:

1-14. Rejected, irrelevant.

15-20. Rejected, unnecessary. It is not unreasonable to address free standing units or new trauma centers differently that service expansions to existing facilities.

21-22. Rejected, irrelevant.

24-79. Rejected, irrelevant.

81. Rejected, unnecessary.

83-120. Rejected, irrelevant.

121. Rejected, unnecessary. 123-128. Rejected, irrelevant. 130-134. Rejected, irrelevant.

1. Rejected, irrelevant. The rules which set forth the specific requirements for certification supersede application form.

2. Rejected, irrelevant.

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:

11-13. Rejected, unnecessary.

1. Rejected, subordinate.

2. Rejected, unnecessary.

17. Rejected, unnecessary.

19. Rejected, unnecessary.

21-23. Rejected, subordinate.

24. Rejected, irrelevant.

25-27. Rejected, subordinate.

28-29. Rejected, unnecessary.

30. Rejected, not supported by credible evidence.

32. Rejected, unnecessary.

34. Rejected, irrelevant.

36. Rejected, irrelevant.

38-40. Rejected, irrelevant.

41. Rejected, unnecessary. 42-58. Rejected, irrelevant.

59. Rejected, unnecessary. 60-81. Rejected, irrelevant.

82. Rejected, not supported by the greater weight of the evidence. 83-86. Rejected, unnecessary.

1. Rejected, not supported by the greater weight of the evidence.

2. Rejected, irrelevant.

89-91. Rejected, unnecessary.

92. Rejected, contrary to law. The rules set forth the specific requirements which must be met for certification as a provisional SAPTRC. The rule unambiguously requires that the Pediatric Intensive Care Unit medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. There is no legal authority for the DHRS to disregard the requirement, notwithstanding the agency's apparent failure to enforce the rule in previous instances.

Intervenor St. Joseph's Hospital

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

7-9. Rejected, unnecessary.

13-14. Rejected, unnecessary.

16-17. Rejected, unnecessary.

19-31. Rejected, unnecessary.

64-65. Rejected, not supported by the greater weight of the evidence.

Despite the DHRS practice, the rule specifically requires that the referenced personnel be located in the P-ICU. The rule is not satisfied by the SJH proposal.

82. Rejected, not supported by the greater weight of the evidence.

COPIES FURNISHED:

Robert L. Powell, Agency Clerk Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700

Kim Tucker, General Counsel Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700

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

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this Recommended Order. All agencies allow each party at least ten days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the final order in this case.

================================================================= AGENCY FINAL ORDER

=================================================================

STATE OF FLORIDA

DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES

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

Petitioner,

vs. CASE NO. 94-3669

DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES and ST. JOSEPH'S HOSPITAL, INC.,

Respondents.

/

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 submitted a recommended order to the Department of Health and Rehabilitative

Services. A copy of the Recommended Order of Hearing Officer William F. Quattlebaum dated March 3, 1995, is attached hereto and incorporated herein.

RULINGS ON EXCEPTIONS ST. JOSEPH'S EXCEPTIONS

Intervenor St. Joseph's Hospital, Inc. ("SJH") first excepts to finding of fact 40 that SJH fails to comply with the standard which requires literally that "[t]he medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. . . ." The hearing officer found further that

SJH does not propose to place the P-ICU medical director or a physician designated by the P-ICU medical director in the unit 24 hours per day.

Paragraph 40 is supported by competent substantial evidence in the record. The exception is denied.

Intervenor SJH takes exception to finding of fact 41 that SJH proposes to make the P-ICU medical director or designee available to the unit 24 hours per day, rather than make the medical director or designee available in the unit 24 hours per day. The hearing officer finds that "available to" the unit does not require the identified employee to be present in the hospital. The hearing officer further finds that as much as 30 minutes may elapse before the P-ICU medical director or designee arrives at the P-ICU. The agency head cannot reject or modify findings of fact that are supported by competent substantial evidence in the record. Section 120.57(1)(b)(10), Fla. Stat. My review of the record reveals testimony to support paragraph 41 of the Recommended Order.

Having so found, I have no occasion to re-weigh the evidence; thus, SJH's assertion that the hearing officer's rejection of its proposed finding as "not supported by the greater weight of the evidence" is of no avail. The hearing officer merely weighed the evidence and drew permissible inferences therefrom. I cannot substitute SJH's or my own weighing of the evidence for the hearing officer's. The exception is denied.

SJH next excepts to paragraphs 67 and 68, which are conclusions of law concluding that since SJH failed to propose to have the P-ICU medical director or designee present in the unit 24 hours per day, then HRS, in provisionally approving SJH's application for certification, fails to comply with its own rule and SJH's application must be rejected. The hearing officer's conclusions are rejected. While concededly SJH's application disclosed that its coverage of the P-ICU would not include having the medical director or designee physically present in the unit 24 hours per day, it is clear that HRS and the hospital industry do not interpret the rule literally. SJH's application for certification should not be rejected based on its proposed staffing of the P- ICU. While it is true that the literal import of the rule requires 24 hours per day coverage by the medical director or designee in the unit, the evidence adduced at hearing was overwhelming that SJH's proposed coverage is adequate to qualify SJH for the certification it sought.

SJH next excepts to conclusions of law 69 and 70. The hearing officer's paragraph 69 is correct. Paragraph 70 is rejected insofar as it states that in assessing SJH's application for certification, HRS did not comply with its own rules. This is not a case in which the applicant requested additional time or

the department requested additional information. Here, HRS approved SJH's application for provisional certification. The facts adduced at the de novo trial-type administrative hearing demonstrated overwhelmingly that HRS properly approved SJH's application. In reality, no hospital has pediatric medical directors or designees sitting around actually present in a unit 24 hours per day waiting for patients to be brought in. Such staffing would be questionable, especially, for example, if there are no patients in the P-ICU.

HRS'S EXCEPTIONS

HRS filed 18 numbered paragraphs of exceptions. Paragraph 8 of HRS's exceptions, disagreeing with the hearing officer's conclusion that SJH was not in substantial compliance with standard IX A, C, 1, is granted. The record shows that SJH is in substantial compliance with all applicable standards, including having the P-ICU medical director or designee available as needed for proper coverage consistent with proper operation of the unit as measured by the actual practice in Florida.

Paragraph 10 of HRS's exceptions is granted with respect to the last sentence of paragraph 68 and the last sentence of paragraph 70 of the Recommended Order, for the reasons stated above in ruling on SJH's exceptions.

Paragraph 14 of HRS's exceptions, except for the last sentence of paragraph 42, is denied. The hearing officer's findings 40, 41 and 42 are supported by record evidence, except for the following: "There is no legal authority for the DHRS to disregard the requirement set forth in its own rules." There is no record evidence to support the sentence quoted next above, which would seem to more properly be a conclusion of law instead of a finding of fact.

Paragraph 18 of HRS's exceptions is granted. The second sentence of Conclusion of Law 59 in the Recommended Order is rejected.

TAMPA GENERAL'S EXCEPTIONS

Section III, beginning on page 9 of Tampa General's ("TGH") exceptions, is TGH's first exception to the Recommended Order. Petitioner urges that conclusion of law 60 be rejected. Conclusion 60 provides in essence that lack of an appropriate state trauma services plan and lack of adequate review of local plans prior to their adoption, if, indeed, any such alleged transgression there be,

...are outside the scope of this proceeding. The issue in this case is whether the SJH application meets the requirements of statute and rule and is therefore entitled to approval.

Tampa General admits, however, that the stipulated facts, voluntarily agreed to by TGH, led to the granting of SJH's motion in limine to preclude evidence of lack of need for a new pediatric trauma center in the service area. Tampa General failed to preserve for litigation the issue of lack of need and adverse impact on TGH if an allegedly unneeded pediatric trauma center were approved for provisional certification. Tampa General waived litigtion of the issue of need for a new pediatric trauma center in the service area by stipulating that need was not at issue in this proceeding. The exception is denied.

Tampa General next excepts, in section IV beginning on page 19 of its exceptions, to the hearing officer's finding that, in this case, approving a new application for a trauma center does not change the number of trauma centers in a service area. My review of the transcript discloses the existence of testimony upon which findings 12 and 13 in the Recommended Order might be bottomed. The exception is denied.

Tampa General's section V, beginning on page 21 of the exceptions, excepts to the hearing officer's broad interpretation of "the statute's grandfathering exemption in a way that allows expansion, not preservation, of the status quo." St. Joseph's Hospital and the HRS Emergency Medical Services office adduced evidence at the hearing upon which the hearing officer properly based his findings of fact 17 and 18 in the Recommended Order. Findings 17 and 18, finding that s. 395.4025(2)(a), Fla. Stat., operates to exempt SJH from the requirement of "consideration of whether the local plan indicates need . . ." is really what TGH excepts to. However, I cannot re-weigh the evidence. The exception is denied.

For its final exception, TGH argues that the hearing officer should have adopted TGH's Proposed Recommended Order, including TGH's proposed findings of fact and conclusions of law. This exception is denied. So long as the findings of fact in the Recommended Order are supported by competent substantial evidence in the record, as is the case here, TGH is inviting me to reweigh the evidence, which is contrary to law. In urging me to disapprove the hearing officer's proper findings of fact and to substitute therefor my own findings of fact, TGH invites the agency head to become the trier of fact. Fact finding is the province of the hearing officer only.

FINDINGS OF FACT

The Department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order, except where inconsistent with the above Rulings on Exceptions.

CONCLUSIONS OF LAW

The Department hereby adopts and incorporates by reference the conclusions of law set forth in the Recommended Order, except where inconsistent with the above Rulings on Exceptions, and except where inconsistent with the following: TGH failed to prove that SJH's application must be denied. The evidence supports the position taken by HRS and SJH.

Based upon the foregoing, it is

ADJUDGED that the petition of Hillsborough County Hospital Authority d/b/a Tampa General Hospital, be and the same is hereby dismissed as without merit.

DONE and ORDERED this 22nd day of June, 1995, in Tallahassee, Florida.

Edward A. Feaver Acting Secretary

Department of Health and Rehabilitative Services

By Richard Hunter

Deputy Secretary for Health

NOTICE OF RIGHT TO JUDICIAL REVIEW

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.

COPIES FURNISHED:

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

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

Elizabeth McArthur, Esquire Radey Hinkle Thomas & McArthur

P. O. 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

Hearing Officer William F. Quattlebaum Division of Administrative Hearings The DeSoto Building

1232 Apalachee Parkway

Tallahassee, Florida 32399-1550

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that a true copy of the foregoing FINAL ORDER has been sent by U.S. Mail and hand delivery to the above-named persons this 23rd day of June , 1995.

Robert L. Powell, Sr. Agency Clerk

Department of Health and Rehabilitative Services Building E, Suite 200 1323 Winewood Blvd.

Tallahassee, Florida 32399-0700

(904) 488-2381

Docket for Case No: 94-003669

Orders for Case No: 94-003669