Department and Services

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

RULE NO: RULE TITLE
59A-3.2085: Department and Services

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 35 No. 23, June 12, 2009 issue of the Florida Administrative Weekly.

These changes modify the application forms incorporated by reference in this rule to remove the requirement for the forms to be submitted under oath and to be notarized, delete language that repeats statutes, and clarify a reference to guidelines incorporated by reference.

59A-3.2085 Department and Services.

(1) through (12) No change.

(13) Adult Diagnostic Cardiac Catheterization Program. All licensed hospitals that establish adult diagnostic cardiac catheterization laboratory services under Section 408.0361, F.S., shall operate in compliance with the guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories. Hospitals are considered to be in compliance with American College of Cardiology/American Heart Association guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The applicable guideline, herein incorporated by reference, is the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 (American College of Cardiology/American Heart Association guidelines). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. All such licensed hospitals shall have a department, service or other similarly titled unit which shall be organized, directed and staffed, and integrated with other units and departments of the hospitals in a manner designed to assure the provision of quality patient care.

(a) Licensure.

1. A hospital seeking a license for an adult diagnostic cardiac catheterization laboratory services program shall submit an application on a form provided by the Agency, AHCA Form 3130-5003, August 09 May 09, License Application Attestation Adult Inpatient Diagnostic Cardiac Catheterization, incorporated herein by reference and available at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml#acs, signed by the chief executive officer of the hospital, confirming attesting to the hospital’s intent and ability to comply with Section 408.0361(1), F.S.:

a. Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories.

b. Perform only adult inpatient diagnostic cardiac catheterization services and not provide therapeutic cardiac catheterization or any other cardiology services.

c. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety.

d. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies.

e. Demonstrate a plan to provide services to Medicaid and charity care patients.

2. Hospitals with adult diagnostic cardiac catheterization services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in Section 408.0361(1), F.S. a. through e. above. Failure to renew the hospital’s license or failure to update the information in a. through e. above shall cause the license to expire.

(b) through (k) No change.

(14) through (15) No change.

(16) Level I Adult Cardiovascular Services.

(a) Licensure.

1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency, AHCA Form 3130-8010, August 09 Feb-09, License Application Attestation Level I Adult Cardiovascular Services, incorporated herein by reference and available at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml#acs, to the Agency, signed by the chief executive officer of the hospital, confirming attesting that for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9).

a. Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session.

b. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant.

2. The request shall confirm attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.

3. The request shall confirm attest to the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in 419.2.1.2, Florida Building Code.

4. through 10. No change.

(b) through (g) No change.

(17) Level II Adult Cardiovascular Services.

(a) Licensure.

1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency, AHCA Form 3130-8011, Feb-09, License Application Attestation Level II Adult Cardiovascular Services, incorporated herein by reference and available at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml#acs, to the Agency, signed by the chief executive officer of the hospital, confirming attesting that for the most recent 12-month period, the hospital has provided a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9).

a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant.

2. The request shall confirm attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.

3. The request shall confirm attest to the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in 419.2.1.2, Florida Building Code.

4. through 7. No change.

(b) through (f) No change.

(18) No change.