Effective 8-23-95

59C-1.032 Cardiac Catheterization and Angioplasty Institutional Health Services

(1) Agency Intent. This rule amendment implements the provision of section 408.036(3)(k) which provides that a certificate of need shall not be required for an expenditure to provide an outpatient service. This rule defines the requirements for the establishment of inpatient cardiac catheterization services, including minimum requirements for staffing, equipment, and a numeric need methodology for cardiac catheterization programs. A certificate of need for the establishment of inpatient cardiac catheterization services shall not normally be approved unless the applicant meets the applicable review criteria in section 408.035, F.S., and the standards and need determination criteria set forth in this rule. A cardiac catheterization program which is established and utilized for the purpose of serving outpatients exclusively is not regulated under this rule. A cardiac catheterization program which provides services to inpatients, regardless of the reason for their admission, including coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts, or pediatric cardiac catheterization, requires a certificate of need. Hospitals operating more than one hospital facility under the same hospital license in the same district, shall obtain a separate certificate of need for the establishment of a cardiac catheterization program in each health care facility.

(2) Definitions.

(a) Cardiac Catheterization. Cardiac catheterization is defined as a medical 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. Cardiac catheterization also includes the selective catheterization of the coronary ostia with injection of contrast medium into the coronary arteries

(b) Coronary Angioplasty. Coronary angioplasty is defined as a hospital inpatient procedure requiring the dilation of narrowed segments of the coronary vessels, via a balloon-tipped catheter.

(c) Catheterization Program. A cardiac catheterization program is defined as an institutional health service which is provided by or on behalf of a health care facility and which consists of one or more laboratories which comprise a room or suite of rooms, and has the equipment and staff required to perform cardiac catheterization serving inpatients and outpatients. A cardiac catheterization program approved for angioplasty services, or other types of therapeutic cardiac procedures shall have the additional necessary equipment and staff to perform angioplasty procedures.

(d) Approved Program. A proposed cardiac catheterization and angioplasty program, not operational as defined by this rule, for which a certificate of need, a letter of intent to grant a certificate of need, or a final order granting a certificate of need was issued, consistent with the provisions of 59C-1.008(2)(b), Florida Administrative Code, on or before the most recent published deadline for agency decisions prior to publication of the fixed need pool, as specified in 59C-1.008(1)(g), Florida Administrative Code.

(e) Cardiac Catheterization Annual Program Volume. The cardiac catheterization annual program volume equals the total number of inpatient and outpatient admissions to the cardiac catheterization program, for the purpose of cardiac catheterization or angioplasty, for the 12 month period specified in paragraph (8)(c). A single admission is equivalent to one patient visit to the cardiac catheterization program. Each patient visit will be counted in determining the actual program volume regardless of whether the patient is an inpatient or outpatient at the facility performing the procedure, or has been admitted as an inpatient or outpatient at another facility.

(f) Inpatient. An inpatient is defined as a person who has been admitted to a hospital for bed occupancy for purposes of receiving inpatient hospital services. A person is considered an inpatient if he was formally admitted as an inpatient with the expectation that he would remain at least overnight and occupy a bed, even though it later develops that he can be discharged or that he is transferred to another hospital and does not actually use a hospital bed overnight. An inpatient of a hospital cannot be considered an outpatient of that or any other hospital at the same time.

(g) Outpatient. An outpatient is defined as a person who receives cardiac catheterization in a health care facility and does not meet the definition of inpatient in paragraph (e).

(h) Service Planning Area. The service planning area for a cardiac catheterization program is the applicable district unless cardiac catheterization subdistricts have been defined by the respective local health council and promulgated into rule by the agency. Planning for pediatric cardiac catheterization services shall be done on a regionalized basis. Certificate of need applications for pediatric cardiac catheterization services shall be competitively reviewed within each of the following five regions. The planning regions for pediatric services shall be:

1. Service Planning Area I includes districts 1 and 2.

2. Service Planning Area II includes districts 3 and 4.

3. Service Planning Area III includes districts 5, 6 and 8.

4. Service Area IV includes districts 7 and 9.

5. Service Area VI includes districts 10 and 11.

(i) Operational Program. A new cardiac catheterization and angioplasty program approved by the agency that has performed at least one inpatient or outpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or, in the case of programs which performed only outpatient cardiac catheterization prior to agency approval, a program that has performed at least one inpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool.

(3) Scope of Service.

(a) Each cardiac catheterization program shall be capable of providing immediate endocardiac catheter pacemaking in cases of cardiac arrest, and pressure recording for monitoring and to evaluate valvular disease, or heart failure. Applicants for cardiac catheterization programs shall document the manner in which they will meet this requirement.

(b) A range of non-invasive cardiac or circulatory diagnostic services must be available within the health care facility itself, including:

1. Hematology studies or coagulation studies;

2. Electrocardiography;

3. Chest x-ray;

4. Blood gas studies; and

5. Clinical pathology studies and blood chemistry analysis.

(c) At a minimum a cardiac catheterization program shall include:

1. A special procedure x-ray room;

2. A film storage and darkroom for proper processing of films;

3. X-ray equipment with the capability in cineangiocardiography, or equipment with similar capabilities;

4. An image intensifier;

5. An automatic injector;

6. A diagnostic x-ray examination table for special procedures;

7. An electrocardiograph;

8. A blood gas analyzer;

9. A multichannel polygraph; and

10 Emergency equipment including but not limited to a temporary pacemaker unit with catheters, ventilitory assistance devices, and a DC defibrillator.

(4) Service Accessibility.

(a) Travel Standard. An adult inpatient cardiac catheterization program shall be available within a maximum automobile travel time of 1 hour, under average travel conditions, for at least 90 percent of a service planning area's population provided that the cardiac catheterization program can meet other applicable statutory and related rule criteria.

(b) Hours of Operation. Every cardiac catheterization program shall have the capability of rapid mobilization of the study team within 30 minutes for emergency procedures 24 hours a day, 7 days a week. Applicants for new cardiac catheterization programs shall document the manner in which they will meet this requirement.

(c) Underserved Population Groups. Applicants for a cardiac catheterization program shall indicate the projected number of medically indigent and Medicaid patients to be served annually. Applicants shall indicate their past provision of health care services to medically indigent and Medicaid patients.

(5) Service Quality.

(a) Accreditation. Any health care facility providing inpatient catheterization only, or inpatient and outpatient cardiac catheterization, or angioplasty, must be fully accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) for special care units, or be accredited by the American Osteopathic Association.

(b) Availability of Health Personnel. Any applicant proposing to establish a cardiac catheterization program must document that adequate numbers of properly trained personnel will be available. At a minimum, a team involved in cardiac catheterization consists of a physician, one nurse, and one or more technicians. An applicant for a new cardiac catheterization program shall document that the following staff are available:

1. A program director, board-certified or board-eligible in internal medicine, or radiology with subspecialty training in cardiology or cardiovascular, radiology; the program director for programs performing pediatric cardiac catheterization shall be board eligible or board certified by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics or the American Osteopathic Association in the area of pediatric cardiology;

2. A physician, board-certified or board-eligible in cardiology, radiology, or with specialized training in cardiac catheterization and angiographic techniques who will perform the examination;

3. Support staff, specially trained in critical care of cardiac patients, with a knowledge of cardiovascular medication and an understanding of catheterization and angiographic equipment;

4. Support staff, highly skilled in conventional radiographic techniques and angiographic principles, knowledgeable in every aspect of catheterization and angiographic instrumentation, with a thorough knowledge of the anatomy and physiology of the circulatory system;

5. Support staff for patient observation, handling blood samples and performing blood gas evaluation calculations;

6. Support staff for monitoring physiologic data and alerting the physician of any changes;

7. Support staff to perform systematic tests and routine maintenance on cardiac catheterization equipment, who must be available immediately in the event of equipment failure during a procedure;

8. Support staff trained in photographic processing and in the operation of automatic processors used for both sheet and cine film; and

9. A Medical Review Committee which reviews medical invasive procedures such as endoscopy and cardiac catheterization.

(6) Coordination of Services.

(a) Cardiac catheterization programs proposed in a facility not performing open heart surgery must submit a written protocol as part of their certificate of need application for the transfer of emergency patients to a hospital providing open heart surgery, which is within 30 minutes travel time by emergency vehicle under average travel conditions.

(b) Cardiac catheterization programs which include the provision of coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts must be located within a hospital which also provides open heart surgery.

(c) Pediatric cardiac catheterization programs must be located in a hospital in which pediatric open heart surgery is being performed.

(7) Service Cost. Cost data for cardiac catheterization programs, among similar institutions, shall be comparable when patient mix, cost accounting methods, labor market differences and other extenuating factors are taken into account.

(8) Need Determination. In order to assure patient safety and staff efficiency and to achieve maximum economic use of existing resources, the following criteria shall be considered in the approval of certificate of need applications for new adult cardiac catheterization programs.

(a) The minimum annual projected net program volume need for the establishment of a new adult cardiac catheterization program shall be at or exceed an annual program volume of 300 admissions for the service planning area.

(b) Applicants shall demonstrate that they will be able to reach an annual program volume of 300 admissions within 2 years after the program becomes operational.

(c) Need Determination. Numeric need for a new adult cardiac catheterization program in a service planning area is indicated if the difference between the projected program volume and the number of adult cardiac catheterizations performed in the service planning area during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, minus the number of approved adult programs times 300, is at or exceeds a program volume of 300 for the applicable service planning area. This need formula is expressed as follows:

NN = PCCPV - ACCPV - APP

Where:

NN is the 12-month net adult program volume need in the service planning area projected 2 years into the future for the respective planning horizon. Net need projections are published by the agency as a fixed need pool twice a year. The planning horizon for applications submitted between January 1 and June 30 shall be July of the year 2 years subsequent to the year the application is submitted. The planning horizon for applications submitted between July 1 and December 31 shall be January of the year 2 years subsequent to the year which follows the year the application is submitted.

PCCPV is the projected adult cardiac catheterization program volume which equals the actual adult cardiac catheterization program volume rate (ACCPV) per thousand adult population 15 years and over for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, multiplied by the projected adult population 15 years of age and over 2 years into the future for the respective planning horizon. The population projections shall be based on the most recent population projections available from the Executive Office of the Governor which are available to the agency 3 weeks prior to the fixed need pool publication.

ACCPV equals the actual adult cardiac catheterization program volume for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool.

APP is the projected program volume for approved adult programs. The projected program volume for each approved program shall be 300 admissions.

(d) Irrespective of the net need calculated under paragraph (c), no additional cardiac catheterization program shall normally be approved if any of the following conditions exist:

1. One or more of the operational cardiac catheterization programs in the district that were operational for at least 12 months as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool had less than 300 admissions to the cardiac catheterization program during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or

2. One or more of the cardiac catheterization programs in the district that were operational for less than 12 months during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool had less than an average of 25 admissions to the cardiac catheterization program per month.

(e) Pediatric cardiac catheterization programs shall be established on a regional basis. A new pediatric cardiac catheterization program shall not normally be approved unless the number of live births in the service planning area, minus the number of existing and approved programs multiplied by 30,000, is at or exceeds 30,000.

(f) Programs catheterizing pediatric patients only, shall project a minimum service volume of 150 cardiac catheterizations per year within 2 years of the initial operation of the program. Programs serving both adult and pediatric patients shall project a program volume of 350 cardiac catheterizations per year.

(g) Actual inpatient and outpatient migration from one service planning area to another shall be considered in the review of certificate of need applications.

(9) Decisions on certificate of need applications for the expansion of existing programs shall be made on the basis of the applicant's justification for the level of the proposed capital expenditure and the utilization of existing laboratories in the facility.