3701-84-32 Facilities, equipment, and supplies.

(A) The provider of a 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 (e.g., interventional versus diagnostic, teaching versus non-teaching).

(B) Each 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 cardiac catheterization services initiated after March 20, 1997, at least five hundred square feet. Each procedure room shall have a designated control room;

(2) Control rooms of at least ninety-six square feet for each procedure room served. Control rooms that are constructed or renovated or cardiac catheterization services initiated after March 20, 1997 shall have at least one hundred and fifty square feet for each procedure room served; 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) Any provider of a cardiac catheterization service in which percutaneous coronary interventions (PCI) will be performed shall ensure that the facility where the PCI will be performed contains one or more surgical suites that are equipped to accommodate thoracic and cardiac surgical procedures, including procedures requiring cardiopulmonary bypass, with appropriate staff available in less than sixty minutes.

(E) Equipment described in this paragraph and paragraph (F) of this rule may be replaced by newer technology that has equivalent or superior capability as determined by the provider of the HCS. 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). All cardiac catheterization services shall, at a minimum have the following equipment:

(1) High quality x-ray imaging with multi axial position capability;

(2) A three-phase, twelve pulse generator with an output of eighty to one hundred kilowatts or a constant potential generator with an output of at least one hundred kilowatts at one hundred kilovolts;

(3) Multimode or cesium iodide image intensifiers;

(4) High-quality matched optics;

(5) A synchronous thirty-five millimeter camera or other appropriate imaging modality for review and storage of images;

(6) Television fluoroscopy;

(7) Carbon-fiber table tops;

(8) Power injectors capable of delivering up to fifty milliliters per second;

(9) A mechanism for continuous monitoring of a patient's blood pressure and electrocardiogram;

(10) An adequate supply and variety of catheters, guide wires, and sheaths;

(11) A crash cart with equipment for ventilatory support;

(12) A defibrillator; and,

(13) A temporary pacemaker.

(F) In addition to requirements identified in paragraph (E) of this rule, the provider of a cardiac catheterization service that will perform percutaneous coronary interventions (PCI) shall have, at a minimum, the following equipment:

(1) An ample inventory of balloon dilation catheters;

(2) An intra aortic balloon pump;

(3) A high resolution fluoroscopic system and optimal TV chain; and

(4) Either biplane fluoroscopy or an angulating x-ray tube image intensifier arm.

(G) The provider of a 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.

R.C. 119.032 review dates: 05/11/2012 and 05/01/2017
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: 3/20/1997, 3/24/03, 5/15/08