Ohio Admin. Code 3701-84-30.4

Current through all regulations passed and filed through December 2, 2024

Section 3701-84-30.4 - Adult electrophysiology procedure rooms

(A) Adult electrophysiology studies may be conducted in any level adult cardiac catheterization laboratory or an electrophysiology procedure room.

(B) Procedure rooms where adult electrophysiology studies are conducted will:

(1) Have a minimum floor area of three hundred fifty square feet.

(2) Have the following minimum clearances:

(a) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field; and

(b) Clearance at the head of the bed should be allocated for anesthesia equipment on either side and sterile access to jugular vein entry sites, if employed, while allowing for free range of movement of a fluoroscopy C-arm.

(3) Hybrid procedure rooms where adult electrophysiology studies are conducted will meet the minimum clear floor area and clearances of paragraphs (B)(1) and (B)(2) of this rule and include at least the additional minimum clear floor area, clearances, and storage requirements for the imaging equipment contained in the room.

(4) Provide the following:

(a) Positive airflow;

(b) High flow oxygen and vacuum for suctioning;

(c) Medical gas availability;

(d) Substerile scrub area; and

(e) A patient post-procedural care area.

(5) Provide adequate utilities based upon the types of procedures and workload, including:

(a) Water taps;

(b) Overhead and task lighting will be adequate to perform electrophysiology procedures and for clinical evaluation and treatment of the patient and include:

(i) Overhead lighting will be able to be dimmed during fluoroscopy;

(ii) Lighting to flood the main procedure area; and

(iii) A dedicated workspace light for the nursing/anesthesia area.

(c) Electrical outlets;

(d) Emergency power;

(e) Telephones;

(f) Heating and cooling; and

(g) Ventilation.

(C) The following equipment will be available to each procedure room where adult electrophysiology studies are conducted:

(1) Electrogram recording systems;

(2) Programmed stimulators;

(3) Defibrillator;

(4) Electrocardiogram and hemodynamic monitoring equipment;

(5) Non-invasive blood pressure monitor;

(6) Supplies specific to the procedure being performed;

(7) Emergency equipment and supplies;

(8) If the procedure requires fluoroscopy, radiation shielded barriers that meet state and federal requirements are required; and

(9) When determined necessary, three-dimensional (3D) mapping systems may be provided by a service onsite or through agreement or contract with another hospital.

(D) Electrophysiology study numbers are to be included in each adult cardiac catheterization service's annual report of the number and type of procedures performed.

Ohio Admin. Code 3701-84-30.4

Effective: 5/15/2023
Five Year Review (FYR) Dates: 05/05/2028
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18