Florida Administrative Code › 59 - AGENCY FOR HEALTH CARE ADMINISTRATION › 59C - Certificate of Need › Chapter 59C-1 - PROCEDURES FOR THE ADMINISTRATION OF SECTIONS 408.031-408.045, FLORIDA STATUTES, HEALTH FACILITY AND SERVICES DEVELOPMENT ACT › Section 59C-1.032 - Pediatric Cardiac Catheterization and Angioplasty Institutional Health Services

Current through Reg. 50, No. 138; July 16, 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.