The Agency proposes to amend Rule 59A-3.2085, Florida Administrative Code, consistent with provisions of Section 408.0361, Florida Statutes. This section includes standards for adult diagnostic cardiac catheterization services in hospitals, and ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

RULE NO: RULE TITLE
59A-3.2085: Department and Services
PURPOSE AND EFFECT: The Agency proposes to amend Rule 59A-3.2085, Florida Administrative Code, consistent with provisions of Section 408.0361, Florida Statutes. This section includes standards for adult diagnostic cardiac catheterization services in hospitals, and provides for adoption of rules to establish a licensure process for hospital-based adult cardiovascular programs in Florida hospitals and to adopt standards for those programs.
SUMMARY: The proposed amendments to this rule establish standards for licensure of adult cardiovascular programs in Florida hospitals.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 408.0361(1) FS.
LAW IMPLEMENTED: 408.0361 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: October 26, 2007, 1:00 p.m.
PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room A, Tallahassee, FL 32308.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Tara E. Ehlers by e-mail at [e-mail] or by phone at [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jeffrey Gregg, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, or call [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-3.2085 Department and Services.

(1) through (12) No change.

(13) Adult Inpatient 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. 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. Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. All licensed hospitals that establish an Adult Inpatient Diagnostic Cardiac Catheterization Program after July 1, 1997 pursuant to an exemption granted under Section 408.036(3)(n), F.S., shall comply with the provisions of the ACC/AHA Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories JACC Volume 18, Number 5 of November 1, 1991, which establish the standards for Cardiac Catheterization and Cardiac Catheterization Laboratories, and which is hereby incorporated by reference, except as modified herein.

All such exempted 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.

1.3. “Diagnostic Cardiac Catheterization” means a procedure requiring the passage of a catheter into one or more cardiac chambers of the left and right heart, with or without coronary arteriograms, for the purpose of diagnosing congenital or acquired cardiovascular diseases, or for determining measurement of blood pressure flow; and also includes the selective catheterization of the coronary ostia with injection of contrast medium into the coronary arteries.

(a) Definitions. The following definitions shall apply specifically to all adult inpatient diagnostic cardiac catheterization programs, as described in this subsection 59A-3.2085(13), F.A.C.:

1. “ACC/AHA” means the American College of Cardiology/American Heart Association.

2. “JACC” means the Journal of the American College of Cardiology.

2.4. “Adult Inpatient” means a person fifteen years of age or older who has been admitted for bed occupancy for the purposes of receiving inpatient hospital services.

5. “Annual Program Volume” means the total number of inpatient and outpatient admissions to the adult cardiac catheterization program, for the purpose of diagnostic cardiac catheterization, for a 12 month period. A single admission is equivalent to one patient visit to the cardiac catheterization program. Each patient visit shall be counted in determining the actual program volume regardless of whether the patient is an inpatient or outpatient at the hospital performing the procedure, or has been admitted as an inpatient or outpatient at another facility.

3.(b) Therapeutic Procedures. An adult diagnostic cardiac catheterization program established pursuant to an exemption granted under Section 408.0361, 408.036(3)(n), F.S., shall not provide therapeutic services, such as balloon angioplasty percutaneous coronary intervention or stent insertion, intended to treat an identified condition or the administering of intra-coronary drugs, such as thrombolytic agents.

4.(c) Diagnostic Procedures. Procedures performed in the adult diagnostic cardiac catheterization laboratory shall include, for example, the following:

a.1. Left heart catheterization with coronary angiography and left ventriculography

b.2. Right heart catheterization

c.3. Hemodynamic monitoring line insertion

d.4. Aortogram

e.5. Emergency temporary pacemaker insertion

6. Transesophageal electric pacing

f.7. Myocardial biopsy

g.8. Diagnostic trans-septal procedures

h.9. Intra-coronary ultrasound (ICUS)

i.10. Fluoroscopy

j.11. Hemodynamic stress testing

(d) Annual Program Volume. The minimum program volume for an adult diagnostic cardiac catheterization service shall be either 300 admissions during the 12-month period commencing 18 months after a program becomes operational, or 150 admissions by at least one physician who performed diagnostic cardiac catheterizations during that period, with a second physician with at least 100 admissions for adult diagnostic cardiac catheterization during the same period. The program volume standard shall be met during each subsequent 12-month period. An annual report of compliance with this requirement shall be forwarded to the Agency’s Certificate of Need Office.

(b)(e) Support Equipment. A crash cart containing the necessary medication and equipment for ventilatory support shall be located in each cardiac catheterization procedure room. A listing of all crash cart contents shall be readily available. At the beginning of each shift, the crash cart shall be checked for intact lock; the defribrillator and corresponding equipment shall be checked for function and operational capacity. A log shall be maintained indicating review.

(c) Radiographic Cardiac Imaging Systems. A quality improvement program for radiographic imaging systems shall include measures of image quality, dynamic range and modulation transfer function. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(d)(f) Physical Plant Requirements. Section 419.2.1.2, Florida Building Code, subsection 59A-3.081(53), F.A.C., contains the physical plant requirements for the adult diagnostic inpatient cardiac catheterization program.

(e)(g) Personnel Requirements. There shall be an adequate number of trained personnel available. At a minimum, a team involved in cardiac catheterization shall consist of a physician, one registered nurse, and one technician.

(f) Quality Improvement Program. A quality improvement program for the adult diagnostic cardiac catheterization program laboratory shall include an assessment of proficiency in diagnostic coronary procedures, as described in the American College of Cardiology/American Heart Association Guidelines. Essential data elements for the quality improvement program include the individual physician procedural volume and major complication rate; the institutional procedural complication rate; relevant clinical and demographic information about patients; verification of data accuracy; and procedures for patient, physician and staff confidentiality. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(g)(h) Emergency Services. Cardiac catheterization programs in a hospital not performing open heart surgery shall have a written protocol for the transfer of emergency patients to a hospital providing open heart surgery, which is within thirty minutes travel time by emergency vehicle under average travel conditions.

1. All providers of adult diagnostic cardiac catheterization program services in a hospital not 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 that operate a Level II adult cardiovascular services program. Written agreements must be in place to ensure safe and efficient emergency transfer of a patient 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 at least every 3 months, with appropriate documentation maintained, including the hospital’s internal log or emergency medical services data. Each program shall be capable of providing immediate endocardiac catheter pacemaking in case of cardiac arrest and pressure recording for monitoring and evaluating valvular disease, or heart failure. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

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. For example, patients actively infracting should be defined as high risk and be immediately transported to a hospital where on-site open-heart surgery is available. 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.

3. Each adult diagnostic cardiac catherterization program shall have the capability to rapid mobilization of its team 23 hours a day, 7 days a week. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(h) 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. At a minimum, the policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for adult diagnostic cardiac catheterization services.

(i) Enforcement.  Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Each diagnostic catheterization program shall provide a minimum of 2 percent of its admissions to charity and Medicaid patients each year. An annual report of compliance with this requirement shall be forwarded to the Agency’s Certificate of Need Office.

(j) In case of conflict between the provisions of this rule and the guidelines of the American College of Cardiology, the provisions of this part shall prevail.

(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 (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule _______), signed by the chief executive officer of the hospital, 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 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 and physical plant criteria.

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

4. The request shall also include copies of one or more written transfer agreements with hospitals that operate a Level II adult cardiovascular services program, including written transport protocols to ensure safe and efficient transfer of an emergency patient 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.

5. All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A-3.2085(13), F.A.C., and the guidelines of the American College of Cardiology/American Heart Association regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention.

6. The applicable guidelines, herein incorporated by reference, are 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). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule.

7. 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 and physical plant criteria. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry.

8. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry.

a. Each hospital licensed to provide Level I adult cardiovascular services shall execute the required agreements with the American College of Cardiology-National Cardiovascular Data Registry to participate in the data registry.

b. Each hospital licensed to provide Level I adult cardiovascular services shall stay current with the payment of all fees necessary to continue participation in the American College of Cardiology-National Cardiovascular Data Registry.

c. Each hospital licensed to provide Level I adult cardiovascular services shall release the data reported by the American College of Cardiology-National Cardiovascular Data Registry to the Agency for Health Care Administration.

d. Each hospital licensed to provide Level I adult cardiovascular services shall use the American College of Cardiology-National Cardiovascular Data Registry data sets and use software approved by the American College of Cardiology for data reporting.

e. Each hospital licensed to provide Level I adult cardiovascular services shall ensure that software formats are established and maintained in a manner that meets American College of Cardiology-National Cardiovascular Data Registry transmission specifications and encryption requirements. If necessary, each hospital shall contract with a vendor approved by the American College of Cardiology-National Cardiovascular Data Registry for software and hardware required for data collection and reporting.

f. To the extent required by the  American College of Cardiology-National Cardiovascular Data Registry, each hospital licensed to provide Level I adult cardiovascular services shall implement procedures to transmit data via a secure website or other means necessary to protect patient privacy.

g. Each hospital licensed to provide Level I adult cardiovascular services shall ensure that all appropriate data is submitted on every patient that receives medical care and is eligible for inclusion in the American College of Cardiology-National Cardiovascular Data Registry.

h. Each hospital licensed to provide Level I adult cardiovascular services shall maintain an updated and current institutional profile with the American College of Cardiology-National Cardiovascular Data Registry.

i. Each hospital licensed to provide Level I adult cardiovascular services shall ensure that data collection and reporting will only be performed by trained, competent staff and that such staff shall adhere to the American College of Cardiology-National Cardiovascular Data Registry standards.

j. Each hospital licensed to provide Level I adult cardiovascular services shall submit corrections to any data submitted to the American College of Cardiology-National Cardiovascular Data Registry as discovered by the hospital or by the American College of Cardiology-National Cardiovascular Data Registry. Such corrections shall be submitted within thirty days of discovery of the need for a correction or within such other time frame as set forth by the American College of Cardiology-National Cardiovascular Data Registry.  Data submitted must be at a level that the American College of Cardiology-National Cardiovascular Data Registry will include the data in national benchmark reporting.

k. Each hospital licensed to provide Level I adult cardiovascular services shall designate an American College of Cardiology-National Cardiovascular Data Registry site manager that will serve as a primary contact between the hospital, the American College of Cardiology-National Cardiovascular Data Registry and  the Agency with regard to data reporting. The identity of each site manager shall be provided to the Hospital and Outpatient Services Unit at the Agency for Health Care Administration in Tallahassee.

l. By submitting data to the American College of Cardiology-National Cardiovascular Data Registry in the manner set forth herein, each hospital shall be deemed to have certified that the data submitted for each time period is accurate, complete and verifiable.

9. Notwithstanding American College of Cardiology/American Heart Association guidelines to the contrary, all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures.  Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule.

10. Hospitals with Level I adult cardiovascular services programs are prohibited from providing the following procedures:

a. Any therapeutic procedure requiring transseptal puncture, or

b. Any lead extraction for a pacemaker, biventricular pacer or implanted cardioverter defibrillator.

11. Hospitals with Level I adult cardiovascular services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in two through five above.  Failure to renew the hospital’s license or failure to update the information in two through five above shall cause the license to expire.

(b) Staffing.

1. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application.

2. Physicians with less than 12 months experience shall fulfill applicable American College of Cardiology/American Heart Association training requirements prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program.

3. The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.

4. The hospital shall ensure that a member of the cardiac care nursing staff who is adept in hemodynamic monitoring and Intra-aortic Balloon Pump (IABP) management shall be in the hospital at all times.

(c) Emergency Services.

1. A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient 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 at least every 3 months, with appropriate documentation maintained.

(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. At a minimum, the policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level I adult cardiovascular services.

(e) Physical Plant Requirements.

Section 419.2.1.2, Florida Building Code, contains the physical plant requirements for adult cardiac catheterization laboratories operated by a licensed hospital.

(f) Enforcement.

1. Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C.

2. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency.

3. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction.

(g) In case of conflict between the provisions of this rule and the guidelines of the American College of Cardiology, the provisions of this part shall prevail.

(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 (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form______, Section 18(b) of this rule____) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 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 attest to the hospital’s intent and ability to comply with applicable American College of Cardiology/American Heart Association guidelines including guidelines for staffing, physician training and experience, operating procedures, equipment and physical plant.

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

4. All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery.

a. The applicable guidelines, herein incorporated by reference, are 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

b. 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

c. 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.

d. 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 American College of Cardiology/American Heart Association guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment and physical plant criteria. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons.

6. In addition to the requirements set forth in subsection (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database.

a. Each hospital licensed to provide Level II adult cardiovascular services shall report to the Society of Thoracic Surgeons National Database in accordance with the timetables and procedures established by the Database. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the Society of Thoracic Surgeons.

b. Each hospital licensed to provide Level II adult cardiovascular services shall stay current with the payment of all fees necessary to continue participation in the Society of Thoracic Surgeons data registry.

c. Each hospital licensed to provide Level II adult cardiovascular services shall release the data reported by the Society of Thoracic Surgeons National Database to the Agency.

d. Each hospital licensed to provide Level II adult cardiovascular services shall use the most current version of the Society of Thoracic Surgeons National Database and use software approved by the Society of Thoracic Surgeons for data reporting.

e. Each hospital licensed to provide Level II adult cardiovascular services shall ensure that software formats are established and maintained in a manner that meets Society of Thoracic Surgeons transmission specifications and encryption requirements.  If necessary, each hospital shall contract with a vendor approved by the Society of Thoracic Surgeons National Database for software and hardware required for data collection and reporting.

f. To the extent required by the Society of Thoracic Surgeons National Database, each hospital licensed to provide Level II adult cardiovascular services shall implement procedures to transmit data via a secure website or other means necessary to protect patient privacy.

g. Each hospital licensed to provide Level II adult cardiovascular services shall ensure that all appropriate data is submitted on every patient who receives medical care and is eligible for inclusion in the Society of Thoracic Surgeons National Database.

h. Each hospital licensed to provide Level II adult cardiovascular services shall maintain an updated and current institutional profile with the Society of Thoracic Surgeons National Database.

i. Each hospital licensed to provide Level II adult cardiovascular services shall ensure that data collection and reporting will only be performed by trained, competent staff and that such staff shall adhere to Society of Thoracic Surgeons National Database standards.

j. Each hospital licensed to provide Level II adult cardiovascular services shall submit corrections to any data submitted to the Society of Thoracic Surgeons National Database as discovered by the hospital or by the Society of Thoracic Surgeons National Database.  Such corrections shall be submitted within thirty days of discovery of the need for a correction or within such other time frame as set forth by the Society of Thoracic Surgeons National Database. Data submitted must be at a level that the Society of Thoracic Surgeons National Database will include the data in national benchmark reporting.

k. Each hospital licensed to provide Level II adult cardiovascular services shall designate a Society of Thoracic Surgeons National Database site manager that will serve as a primary contact between the hospital, the  Society of Thoracic Surgeons National Database and the Agency with regard to data reporting.  The identity of each site manager shall be provided to the Hospital and Outpatient Services Unit at the Agency for Health Care Administration in Tallahassee.

j. By submitting data to the Society of Thoracic Surgeons National Database and the American College of Cardiology-National Cardiovascular Data Registry in the manner set forth herein, each hospital shall be deemed to have certified that the data submitted for each time period is accurate, complete and verifiable.

7. Hospitals with Level II adult cardiovascular services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in two through four above. Failure to renew the hospital’s license or failure to update the information in one through four above shall cause the license to expire.

(b) Staffing.

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. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application.

3. The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.

4. The hospital shall ensure that a member of the cardiac care nursing staff who is adept in hemodynamic monitoring and Intra-aortic Balloon Pump (IABP) management shall be in the hospital at all times.

(c) Policy and Procedure Manual for Medicaid and Charity Care.

1. Each provider of adult 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. At a minimum, the policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level II adult cardiovascular services.

(d) Physical Plant Requirements.

Section 419.2.1.2, Florida Building Code, contains the physical plant requirements for adult cardiac catheterization laboratories and operating rooms for cardiac surgery operated by a licensed hospital.

(e) Enforcement.

1. Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C.

2. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency.

3. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction.

(f) In case of conflict between the provisions of this rule and the guidelines of the American College of Cardiology, the provisions of this part shall prevail.

(18) Forms.

(a) Form 1: Level I Adult Cardiovascular Services License Application. AHCA Form_____.

Attestation

AHCA Facility Number:

Facility Name:

Facility/Premise Address:

12-month Reporting Period:

Volume:

Total number of adult cardiac catheterization patients/ sessions:

Inpatient Sessions:

Outpatient Sessions:

Or

Total number of inpatient discharges or transfers with principal diagnosis of ischemic heart disease (ICD-9-CM codes 410.0 through 414.9)

Inpatient Discharges:

Inpatient Transfers:

I, the undersigned, upon oath and affirmation of belief and  personal knowledge, attest that the above named hospital volume are true, accurate, and complete.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital will fully comply, where applicable, with the guidelines of the American College of Cardiology/American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment and  physical plant criteria to ensure quality patient care and safety, except where they are in conflict with Florida law.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital will fully comply with the physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in Section 419.2.1.2, Florida Building Code as applicable.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital has a formalized, written transfer agreement with a hospital that has a Level II adult cardiovascular program, including a written transport agreement(s) to ensure safe and efficient transfer of a patient within 60 minutes.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital will participate in the American College of Cardiology National Cardiovascular Data Registry.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital has a formalized plan to provide services to Medicaid and charity care patients in need of Level I adult cardiovascular services.

I,_______, hereby swear or affirm that the statements in this attestation are true and correct.

Signature of Chief Executive OfficerDate

STATE OF FLORIDA

COUNTY OF________ 

Sworn to and subscribed before me this______, _______ by________.

This individual is personally known to me or produced the following identification: ________

Notary Public

NOTARY SEAL:

(b) Form 2: Level II Adult Cardiovascular Services License Application. AHCA Form_______.

Attestation

AHCA Facility Number:

Facility Name:

Facility/Premise Address:

12-month Reporting Period:

Volume:

Total number of adult cardiac catheterization patients/ sessions:

Inpatient Sessions:

Outpatient Sessions:

Or

Total number of inpatient discharges or transfers with principal diagnosis of ischemic heart disease (ICD-9-CM codes 410.0 through 414.9)

Inpatient Discharges:

Inpatient Transfers:

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital volume are true, accurate, and complete.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital will fully comply with the guidelines of the American College of Cardiology/American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment and physical plant criteria to ensure patient quality and safety.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above named hospital will fully comply with the physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in Section 419.2.1.2, Florida Building Code as applicable.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above name hospital will participate in the American College of Cardiology National Cardiovascular Data Registry and the Society of Thoracic Surgeons National Database.

I, the undersigned, upon oath and affirmation of belief and personal knowledge, attest that the above name hospital/facility has a formalized plan to provide services to Medicaid and charity care patients in need of Level II adult cardiovascular services.

I,_____, hereby swear or affirm that the statements in this attestation are true and correct.

Signature of Chief Executive OfficerDate

STATE OF FLORIDA

COUNTY OF________ 

Sworn to and subscribed before me this_______, _______by_______.

This individual is personally known to me or produced the following identification:______

Notary Public

NOTARY SEAL:

Specific Authority 395.1055, 395.3038, 395.401, 408.036, 408.0361(1) FS. Law Implemented 395.001, 395.1055, 395.1065, 395.3038, 395.401, 408.036, 408.0361, 957.05 FS. History–New 4-17-97, Amended 3-29-98, 8-23-99, 3-23-06,________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Jeffrey Gregg, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, or call [phone]
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek, Deputy Secretary, Division of Health Quality Assurance, Agency for Health Care Administration
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 19, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 20, 2007