Current through Reg. 50, No. 187; September 24, 2024
(1) Agency
Intent. This rule defines the requirements for the establishment of pediatric
inpatient cardiac catheterization services, including minimum requirements for
staffing, equipment, and a numeric need methodology for pediatric cardiac
catheterization programs. A Certificate of Need for the establishment of
pediatric 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 pediatric
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 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 pediatric cardiac catheterization program in
each health care facility.
(2)
Definitions.
(a) Approved Program. A proposed
pediatric cardiac catheterization and angioplasty program that is not
operational but for which a valid Certificate of Need, a letter of intent to
grant a Certificate of Need, or a final order granting a Certificate of Need
has been issued, consistent with the provisions of paragraph
59C-1.008(2)(b),
F.A.C., on or before the most recently published deadline for Agency initial
decisions prior to publication of the fixed need pool, as specified in
paragraph 59C-1.008
(1)(g), F.A.C.
(b) 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.
(c) 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.
(d)
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.
(e)
Operational Program. A new pediatric cardiac catheterization and angioplasty
program approved by the Agency that has performed at least one pediatric
cardiac catheterization as of 3 months prior to the beginning date of the
quarter of the publication of the fixed need pool.
(f) Pediatric Patient. A person under 15 year
of age.
(g) Service Planning Area.
The service planning area 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 cardiac
catheterization 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.
(3) Scope of Service.
(a) Each pediatric 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 pediatric 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 pediatric 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,
10. Emergency equipment including but not
limited to a temporary pacemaker unit with catheters, ventilatory assistance
devices, and a DC defibrillator,
11. Biplane angiography, with framing rates
of 30-60 fps and injection rates of up to 40 mL/s; and,
12. A crash cart containing the necessary
medication and equipment for ventilatory support; a crash cart shall be located
in each pediatric cardiac catheterization procedure
room.
(4)
Service Accessibility.
(a) Hours of
Operation. Every pediatric 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
pediatric cardiac catheterization programs shall document the manner in which
they will meet this requirement.
(b) Underserved Population Groups. Applicants
for a pediatric 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) Quality of Care. Pediatric cardiac
catheterization programs shall have a department, service or other similarly
titled unit which shall be organized, directed, staffed and integrated with
other units and departments of the hospital in a manner designed to assure the
provision of quality of care. Applicants proposing to establish a new pediatric
cardiac catheterization program shall demonstrate how they will meet this
provision.
(b) Availability of
Health Personnel. Any applicant proposing to establish a pediatric cardiac
catheterization program must document that adequate numbers of properly trained
personnel will be available. At a minimum, a team involved in pediatric cardiac
catheterization consists of a physician, one nurse, and one or more
technicians. An applicant for a new pediatric cardiac catheterization program
shall document that the following staff are available:
1. 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. 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 pediatric
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 pediatric cardiac catheterization
programs.
(a) 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.
(b) Applicants for a new
pediatric cardiac catheterization program shall project a minimum service
volume of 150 cardiac catheterizations per year within 2 years of the initial
operation of the program.
(c)
Actual inpatient and outpatient migration from one service planning area to
another shall be considered in the review of Certificate of Need
applications.
(9)
Utilization Reports. Facilities providing licensed pediatric inpatient cardiac
catheterization services shall provide utilization reports to the Agency or its
designee within 45 days after the end of each calendar quarter. Facilities
shall provide a report of the number of pediatric procedures, for the purpose
of cardiac catheterization or angioplasty, performed by the pediatric cardiac
catheterization program each calendar quarter.
Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law
Implemented 408.032(17), 408.033(3)(b), 408.034(3), 408.035(1), 408.036(1)(f),
408.039(4)(a) FS.
New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81,
4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84,
7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended
6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88,
4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly
10-5.011(1)(e), Amended 11-11-91, 7-6-92, Formerly 10-5.032, Amended 8-24-93,
9-12-94, 6-19-95, 8-23-95, 7-30-17.
