Fla. Admin. Code R. 59A-3.246
(1) Adult Diagnostic Cardiac Catheterization Program. All licensed hospitals that establish adult diagnostic cardiac catheterization laboratory services under Section 395.1055, F.S., shall operate in compliance with the most recent guidelines of the American College of Cardiology and American Heart Association, including collaborating organizations, regarding the operation of diagnostic cardiac catheterization laboratories. Hospitals are considered to be in compliance with American College of Cardiology and 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 is Rao, S, O’Donoghue, M, Ruel, M. et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;151:e771–e862. doi: 10.1161/CIR.0000000000001309 (Guidelines) which is hereby incorporated by reference and effective at adoption. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. The document is available on the World Wide Web site of the American Heart Association at www.ahajournals.org/journal/circ. 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 may apply for licensure to provide adult diagnostic cardiac catheterization laboratory services by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., indicating the addition of an adult diagnostic cardiac catheterization laboratory services program available at: https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure. The license application form must be signed by the hospital’s Chief Executive Officer or the authorized representative, confirming the hospital’s intent and ability to comply with Section 395.1055, F.S.
2. An authorized representative of a hospital providing adult diagnostic cardiac catheterization services must renew this licensed program at the time of the hospital licensure renewal by completing the subsection entitled Adult Cardiovascular Services on the hospital licensure application specified in subsection 59A-3.066(2), F.A.C. Failure to renew the hospital’s license or failure to complete the subsection entitled Adult Cardiovascular Services, thereby not attesting to meeting the requirements, shall cause the licensed program to expire.
3. Hospitals licensed to provide adult diagnostic cardiac catheterization services, and not Level I or Level II adult cardiovascular services may provide the services to patients 15 to 17 years of age provided the physician in charge of the procedure is a pediatric cardiologist or an adult cardiologist with specialized training in adult congenital heart disease.
(c) Diagnostic Cardiac Catheterization Procedures. Procedures performed in the adult diagnostic cardiac catheterization laboratory shall include the following:
1. Left heart catheterization with coronary angiography and left ventriculography;
2. Right heart catheterization;
3. Hemodynamic monitoring line insertion;
4. Aortogram;
5. Emergency temporary pacemaker insertion;
6. Myocardial biopsy;
7. Intra-coronary ultrasound (CVIS);
8. Fluoroscopy; and
9. Hemodynamic stress testing.
(i) Emergency Services.
1. All hospitals providing adult diagnostic cardiac catheterization services, except hospitals licensed as a Level II adult cardiovascular services provider, shall have written transfer agreements developed specifically for diagnostic cardiac catheterization patients with one or more hospitals licensed as a Level II adult cardiovascular services provider. Written agreements must be in place with a ground ambulance service capable of advanced life support and Intra-Aortic Balloon Pump (IABP) transfer. Agreements may include air ambulance service, but must have ground ambulance backup. A transport vehicle must be onsite to begin transport within 30 minutes of a request and have a transfer time within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested once every 6 months, with appropriate documentation maintained, including the hospital’s internal log or emergency medical services data.
2. Patients at high risk for diagnostic catheterization complications shall be referred for diagnostic catheterization services to hospitals licensed as a Level II adult cardiovascular services provider. Hospitals not licensed as a Level II adult cardiovascular services provider must have documented patient selection and exclusion criteria and provision for identification of emergency situations requiring transfer to a hospital with a Level II adult cardiovascular services program. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.
(j) Policy and Procedure Manual for Medicaid and Charity Care.
1. Each provider of adult diagnostic cardiac catheterization services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.
2. The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for adult diagnostic cardiac catheterization services.
(2) Level I Adult Cardiovascular Services.
(a) Licensure.
1. A hospital may apply for licensure to provide Level I adult cardiovascular services by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., indicating the addition of a Level I adult cardiovascular services program. This form is available at: https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure. The hospital licensure application must be signed by the hospital’s Chief Executive Officer or the authorized representative, confirming 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 a minimum of 300 patients with the principal diagnosis of ischemic heart disease (defined by ICD-10-CM codes I20-I25).
a. Reportable cardiac catheterizations 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 catheterizations 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 the hospital’s intent and ability to comply with the following publications, herein incorporated by reference and effective at adoption. The publications are applicable to this section and will be referred to as the Guidelines:
a. Grines CL, BoxLC, Mamas MA, et al. SCAI Expert Consensus Statement on Percutaneous Coronary Intervention Without On-Site Surgical Backup. J Soc Cardiovasc Angiogr Interv. 2023 Jan 30;2(2):100560. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. This document is available on the World Wide Web site of the Journal of the Society for Cardiovascular Angiography and Interventions at https://www.jscai,.org.
b. Rao, S, O’Donoghue, M, Ruel, M. et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;151:e771–e862. doi: 10.1161/CIR.0000000000001309. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. The document is available on the World Wide Web site of the American Heart Association at www.ahajournals.org/journal/circ.
c. Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145:e18–e114. doi: 10.1161/CIR.0000000000001038. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. The document is available on the World Wide Web site of the American Heart Association at www.ahajournals.org/journal/circ.
3. The request shall confirm the hospital’s intent and ability to comply with the Guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.
4. The request shall confirm the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in the Florida Building Code.
5. The request shall confirm the hospital has one or more written transfer agreements with hospitals that operate a Level II adult cardiovascular services program, as specified in paragraph (2)(c), below.
6. All providers of Level I adult cardiovascular services shall operate in compliance with subsection 59A-3.246(1), F.A.C. and the Guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. Level I adult cardiovascular services may be provided to adult patients. Level I adult cardiovascular services may be provided to patients 15 to 17 years of age provided the physician in charge of the procedure is a pediatric cardiologist or an adult cardiologist with specialized training in adult congenital heart disease.
7. Aspects of the Guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the Guidelines related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide cardiovascular surgery are not applicable to this rule.
8. Hospitals are considered to be in compliance with the 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. Hospitals must document an ongoing quality improvement plan designed to analyze data, correct errors, identify system improvements and ongoing improvement in patient care and delivery of services. Hospitals must participate in submission of data to the American College of Cardiology’s National Cardiovascular Data Registry or the American Heart Association’s Get with the Guidelines–Coronary Artery Disease registry to ensure that the Level I program meet or exceed national quality and outcome benchmarks in which the hospital participates. Hospitals providing Level I adult cardiovascular services must have available upon request of the Agency the number of diagnostic and therapeutic adult cardiac catheterizations performed during the most recent 12-month period.
9. Notwithstanding guidelines to the contrary in the Guidelines all providers of Level I adult cardiovascular services may provide emergency and elective percutaneous coronary intervention procedures.
10. Hospitals with Level I adult cardiovascular services programs are prohibited from providing any lead extraction for a pacemaker, biventricular pacer or implanted cardioverter defibrillator.
11. An authorized representative of hospitals with Level I adult cardiovascular services must renew this licensed program at the time of the hospital licensure renewal by completing the subsection entitled Adult Cardiovascular Services on the hospital licensure application specified in subsection 59A-3.066(2), F.A.C. Failure to renew the hospital’s license or failure to complete the subsection entitled Adult Cardiovascular Services, thereby attesting to meeting at least the minimum requirements, shall cause the licensed program to expire.
(b) Staffing. All staff participating as members of the catheterization team, including physicians, nurses, and technical cathererization laboratory staff shall maintain Advanced Cardiac Life Support certification, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.
1. At initial licensure, each cardiologist shall be an experienced physician who has performed a minimum of 50 interventional cardiology procedures, including at least 11 primary cardiology interventional procedures, exclusive of fellowship training, and within the previous 12 months from the date of the Level I adult cardiovascular licensure application.
2. At licensure renewal, interventional cardiologists shall perform a minimum of 50 interventional cardiology procedures per year averaged over a 2-year period or be confirmed by the review process described in subparagraph 59A-3.246(3)(b)3., F.A.C.
3. The providers of Level I adult cardiovascular services shall develop internal review processes to assess interventional cardiologists performing less than the required annual volume. Low volume operators must be evaluated and confirmed by an independent institutional committee consisting of physicians and other healthcare personnel as selected by the hospital, or an external review organization. Factors that shall be considered in assessing operator competence include operator volume, lifetime experience, institutional volume, individual operator’s other cardiovascular interventions and quality assessment of the operator’s ongoing performance.
4. Technical catheterization laboratory staff shall be credentialed as Registered Cardiovascular Invasive Specialists or shall complete a hospital-based education and training program at a hospital providing Level I or Level II adult cardiovascular services. This training program shall include a minimum of 500 hours proctored clinical experience and didactic education components of hemodynamics, pharmacology, arrhythmia recognition, radiation safety, and interventional equipment.
5. Nursing staff within the adult coronary care unit must be trained and experienced with invasive hemodynamic monitoring, operation of temporary pacemaker, management of Intra-Aortic Balloon Pump (IABP), management of in-dwelling arterial/venous sheaths and identifying potential complications such as abrupt closure, recurrent ischemia and access site complications.
(d) Policy and Procedure Manual for Medicaid and Charity Care.
1. Each provider of Level I adult cardiovascular services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.
2. The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level I adult cardiovascular services.
(3) Level II Adult Cardiovascular Services.
(a) Licensure.
1. A hospital may apply for licensure to provide Level II adult cardiovascular services by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., indicating the addition of a Level II adult cardiovascular services program. This form is available at: https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure. The hospital licensure application must be signed by the hospital’s Chief Executive Officer or the authorized representative, confirming 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 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-10-CM codes I20-I25). Reportable cardiac catheterizations 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 the hospital’s intent and ability to comply with the 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 to the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in the Florida Building Code.
4. All providers of Level II adult cardiovascular services shall operate in compliance with subsections (1) and (2) of this rule and the Guidelines regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. Level II adult cardiovascular services may be provided to adult patients. Level II adult cardiovascular services may be provided to patients 15 to 17 years of age provided the physician in charge of the procedure is a pediatric cardiologist or an adult cardiologist with specialized training in adult congenital heart disease. Aspects of the Guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule.
5. Hospitals are considered to be in compliance with the 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. Hospitals must document an ongoing quality improvement plan designed to analyze data, correct errors, identify system improvements and ongoing improvement in patient care and delivery of services. Hospitals must participate in submission of data to the American College of Cardiology’s National Cardiovascular Data Registry or the American Heart Association’s Get with the Guidelines–Coronary Artery Disease registry and participate in the clinical outcome reporting systems operated by the Society of Thoracic Surgeons to ensure that the Level II program and the cardiac surgical program meet or exceed national quality and outcome benchmarks in which the hospital participates. Hospitals providing Level II adult cardiovascular services must have available upon request of the Agency the number of diagnostic and therapeutic adult cardiac catheterizations performed during the most recent 12-month period.
6. An authorized representative of hospitals with Level II adult cardiovascular services must renew this licensed program at the time of the hospital licensure renewal by completing the subsection entitled Adult Cardiovascular Services on the hospital licensure application specified in subsection 59A-3.066(2), F.A.C. Failure to renew the hospital’s license or failure to complete the subsection entitled Adult Cardiovacular Services, thereby attesting to meeting at least the minimum requirements, shall cause the licensed program to expire.
(b) Staffing. All staff participating as members of the catheterization team, including physicians, nurses, and technical catheterization laboratory staff shall maintain Advanced Cardiac Life Support certification, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.
1. Each cardiac surgeon shall be Board certified.
a. New surgeons shall be Board certified within 4 years after completion of their fellowship.
b. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification.
2. All interventional cardiologists shall perform a minimum of 50 coronary interventional procedures per year averaged over a 2-year period which includes at least 11 primary cardiology interventional procedures per year or be confirmed by an internal review process described in this subsection.
3. The providers of Level II adult cardiovascular services shall develop internal review processes to assess interventional cardiologists performing less than the required annual volume. Low volume operators must be evaluated and confirmed by an independent institutional committee consisting of physicians and other healthcare personnel as selected by the hospital, or an external review organization. Factors that shall be considered in assessing operator competence include operator volume, lifetime experience, institutional volume, individual operator’s other cardiovascular interventions and quality assessment of the operator’s ongoing performance.
4. Technical catheterization laboratory staff shall be credentialed as Registered Cardiovascular Invasive Specialists or shall complete a hospital-based education and training program at a hospital providing Level I or Level II adult cardiovascular services. This training program shall include a minimum of 500 hours proctored clinical experience and didactic education components of hemodynamics, pharmacology, arrhythmia recognition, radiation safety, and interventional equipment.
5. Coronary care unit nursing staff must be trained and experienced with invasive hemodynamic monitoring, operation of temporary pacemaker, management of IABP, management of in-dwelling arterial/venous sheaths and identifying potential complications such as abrupt closure, recurrent ischemia and access site complications.
(c) Policy and Procedure Manual for Medicaid and Charity Care.
1. Each provider of Level II adult cardiovascular services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.
2. The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level II adult cardiovascular services.
(4) Stroke centers. Hospitals providing acute stroke ready center, primary stroke center, thrombectomy-capable stroke center, or comprehensive stroke center services shall have the services available 24 hours per day, 7 days per week.
(a) Licensure. A hospital may apply for designation as an acute stroke ready center, primary stroke center, thrombectomy-capable stroke center, or comprehensive stroke center by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., and attaching documentation verifying stroke center certification through:
1. Center for Improvement in Healthcare Quality;
2. DNV GL Healthcare;
3. Health Facilities Accreditation Program; or
4. The Joint Commission.
(5) Burn Units.
Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 395.1065, 395.3038 FS. History–New 8-15-18, Amended 4-22-26.