(A) Each freestanding or mobile diagnostic imaging center shall have equipment necessary to provide services with accuracy, precision, and efficiency as evidenced by:
(1) All diagnostic imaging equipment shall be certified for clinical use by the United States food and drug administration;
(2) All diagnostic imaging equipment specifications and performance shall meet all applicable state and federal requirements; and
(3) The development and maintenance of an equipment management program which shall at a minimum:
(a) Maintain a current inventory of all diagnostic imaging equipment utilized by the freestanding or mobile diagnostic imaging center;
(b) Maintain and identify the clinical applications, maintenance requirements, and equipment malfunction history of all diagnostic imaging equipment utilized by the freestanding or mobile diagnostic imaging center;
(c) Assess the clinical and physical risks of all fixed and mobile equipment utilized in the provision of diagnostic imaging services;
(d) Develop and implement procedures for the regular maintenance and testing of equipment in accordance with manufacturer's guidelines; and
(e) Provide appropriate equipment orientation and training programs for personnel who use or maintain the freestanding or mobile diagnostic imaging center's equipment.
(B) Each freestanding or mobile diagnostic imaging center shall identify, document, and report to the department incidents in which equipment utilized by the diagnostic imaging center contributed or may have contributed to patient injury, illness, or death.
(C) Each freestanding or mobile diagnostic imaging center shall establish and maintain safety guidelines, and practices and policies in accordance with applicable United States nuclear regulatory commission regulations and the applicable provision of Chapter 3748. of the Revised Code and the rules adopted pursuant to that chapter to assure a safe environment for patients, visitors, and personnel.
(D) Safety factors established and maintained by each freestanding or mobile diagnostic imaging center shall also include:
(1) Precautions against electrical and mechanical hazards;
(2) Precautions against the potential interactions of the magnetic field with ferromagnetic objects.
(E) Each freestanding or mobile diagnostic imaging center shall establish and maintain procedures for handling medical emergencies, including emergency cardiac care. Each site at which diagnostic imaging services are provided shall have the equipment, supplies, and personnel necessary to handle clinical emergencies that might occur, including adverse reactions to contrast agents.
(F) Each freestanding or mobile diagnostic imaging center shall have a staff member current in basic life support on duty at the center when patients are there.
Five Year Review (FYR) Dates: 02/16/2016 and 02/15/2021
Promulgated Under: 119.03
Statutory Authority: 3702.13, 3702.30
Rule Amplifies: 3702.12, 3702.13, 3702.30
Prior Effective Dates: 1/13/1996, 9/1/03