(A) Each provider of a pediatric cardiac catheterization service shall provide adequate, properly designed space to perform cardiac catheterization procedures safely and effectively. The amount of space may vary with the types of procedures performed and the nature of the facility such as interventional versus diagnostic and teaching versus non-teaching.
(B) Each pediatric cardiac catheterization service shall utilize the following:
(1) Procedure rooms that meet or exceed minimum space requirements established by the equipment manufacturer and are at least four hundred square feet or, if constructed or renovated or pediatric cardiac catheterization services initiated after March 1, 1997 at least five hundred square feet;
(2) Control rooms of at least ninety-six square feet for each procedure room served. Control rooms that are constructed or renovated or pediatric cardiac catheterization services initiated after March 1, 1997 shall have a minimum of one hundred fifty square feet for each procedure room served. Each procedure room shall have an assigned control room; and
(3) Clean utility rooms that can sufficiently and efficiently supply the procedure rooms.
(C) A general radiology room cannot be used as a cardiac catheterization procedure room.
(D) Each provider of a pediatric cardiac catheterization service shall ensure that each laboratory where a cardiac catheterization procedure is conducted is appropriately equipped to provide high quality pediatric imaging, physiological monitoring, and provision of emergency care.
(E) The equipment described in this paragraph may be replaced by newer technology that has equivalent or superior capability as determined by the provider of the pediatric cardiac catheterization service. In assessing these new technologies, consideration should be given to recommendations of recognized professional societies and accrediting bodies (e.g. the American college of cardiology; the American academy of pediatrics). All pediatric cardiac catheterization services shall, at a minimum, have the following equipment:
(1) Biplane imaging equipment with a movable c-arm;
(2) Immediate replay capabilities;
(3) A blood gas analyzer;
(4) A pulse oximeter;
(5) An infant warming device;
(6) Pacing catheters;
(7) An external pacemaker;
(8) A defibrillator;
(9) An emergency cart; and
(10) A comprehensive inventory of pediatric catheters and devices.
(F) Each provider of a pediatric cardiac catheterization service shall provide and maintain radiation generating equipment in accordance with applicable state and federal requirements as specified in Chapter 3748. of the Revised Code and the rules adopted thereunder.
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07, 6/21/12