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 adult interventional cardiology programs in Florida hospitals and to adopt standards for those programs.
SUMMARY: The proposed amendments to this rule establish standards for adult diagnostic cardiac catheterization services in hospitals and criteria for licensure of interventional cardiology 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.
A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: April 10, 2007, 1:00 p.m.
PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room D, 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: Jeffrey N. Gregg, Chief, Bureau of Health Facility Regulation, [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 N. Gregg, Chief, Bureau of Health Facility Regulation, [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 most recently published guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories.  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.

(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.:

1.3. “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.

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 eighteen 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

f.6. Transesophageal electric pacing

g.7. Myocardial biopsy

h.8. Trans-septal procedures

i.9. Intra-coronary ultrasound (CVIS)

j.10. Fluoroscopy

k.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 coronary interventions, 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, procedures for patient, physician and staff confidentiality; a comparison of outcomes with benchmark data and the ability to risk-stratify patients. 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 interventional cardiology provider shall have written transfer agreements developed specifically for diagnostic cardiac catheterization patients with one or more hospitals that operate a Level II adult interventional cardiology 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 acceptance of the patient by the physician in the receiving hospital 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. 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 interventional cardiology 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 interventional cardiology 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 interventional cardiology 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 catheterization program shall have the capability of rapid mobilization of its team 24 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) 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.

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

(16) Level I Adult Interventional Cardiology Services.

(a) Licensure.

1. A hospital seeking a license for a Level I adult interventional cardiology services program shall submit a request 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 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).

2. The request shall attest to the hospital’s intent and ability to comply with applicable ACC/AHA guidelines including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant and patient selection 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 interventional cardiology 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 acceptance of the patient by the physician in the receiving hospital and the patient’s arrival at the receiving hospital.

5. All providers of Level I adult interventional cardiology services programs shall operate in compliance with subsection 59A-3.2085(13), F.A.C., and the most recently published 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 (PCI).

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.

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).

7. Notwithstanding ACC/AHA guidelines to the contrary, all providers of Level I adult interventional cardiology services programs may provide elective PCI procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule.

8. Hospitals with Level I adult interventional cardiology services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in 2. through 5. above. Failure to renew the hospital’s license and/or the information in 2. through 5. 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 exemption application.

2. Physicians with less than 12 months experience shall fulfill applicable ACC/AHA training requirements (reference ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention) prior to being allowed to perform emergency PCIs in a hospital that is not licensed for a Level II adult interventional cardiology services program.

3. The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump, based on previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult interventional cardiology 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. 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 interventional cardiology services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump (IABP) support to one or more hospitals licensed to operate a Level II adult interventional cardiology services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult interventional cardiology 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 acceptance of the patient by the physician in the receiving hospital 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 interventional cardiology 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 interventional cardiology 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. The Agency shall use outcomes published on the “Florida Compare Care” website to establish priorities for appraisal visits of licensed Level I adult interventional cardiology providers. Providers with higher than expected risk-adjusted mortality rates on measures including “acute myocardial infarction mortality rate” and “acute myocardial infarction mortality rate, without transfer cases” will receive an appraisal visit by the Agency to review the operation of the Level I adult interventional cardiology services program.

3. Level I adult interventional cardiology services programs that fail to meet outcome standards or other provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency.

4. Failure of the hospital with a Level I adult interventional cardiology 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.

(17) Level II Adult Interventional Cardiology Services.

(a) Licensure.

1. A hospital seeking a license for a Level II adult interventional cardiology services program shall submit a request 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).

2. The request shall attest to the hospital’s intent and ability to comply with applicable ACC/AHA 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 interventional cardiology services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A.2085(16), F.A.C. and the most recently published guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention (PCI) 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 TaskForce 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 guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule.

5. Hospitals with Level II adult interventional cardiology services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in 2. through 4. above.  Failure to renew the hospital’s license and/or the information in 1. through 4. 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 exemption application.

2. The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump, based on previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult interventional cardiology 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.

3. 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 interventional cardiology 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 interventional cardiology 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. The Agency shall use outcomes published on the “Florida Compare Care” website to establish priorities for appraisal visits of licensed Level II adult interventional cardiology providers. Providers with higher than expected risk-adjusted mortality rates on measures including “acute myocardial Infarction mortality rate” and “acute myocardial infarction mortality rate, without transfer cases” and “coronary artery bypass graft mortality rate” will receive an appraisal visit by the Agency to review the operation of the Level II adult interventional cardiology services program.

3. Level II adult interventional cardiology services programs that fail to meet outcome standards or other provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency.

4. Failure of the hospital with a Level II adult interventional cardiology 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.

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 N. Gregg, Chief, Bureau of Health Facility Regulation
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek, Deputy Secretary, Health Quality Assurance
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 7, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: December 8, 2006