Section 3701-83-53 - Service standards and equipment - freestanding diagnostic imaging centers(A) Each freestanding or mobile diagnostic imaging center shall have equipment necessary to provide services with accuracy, precision, and efficiency, as evidenced by all of the following:(1) All diagnostic imaging equipment is certified for clinical use by the United States food and drug administration;(2) The specifications and performance of all diagnostic imaging equipment meets all applicable state and federal requirements; and(3) The center's development and maintenance of an equipment management program that, at a minimum: (a) Maintains a current inventory of all diagnostic imaging equipment utilized by the freestanding or mobile diagnostic imaging center;(b) Maintains and identifies the clinical applications, maintenance requirements, and equipment malfunction history of all diagnostic imaging equipment utilized by the freestanding or mobile diagnostic imaging center;(c) Assesses the clinical and physical risks of all fixed and mobile equipment utilized in the provision of diagnostic imaging services;(d) Includes the implementation of establishedprocedures for the regular maintenance and testing of equipment in accordance with manufacturer's guidelines; and(e) Provides appropriate equipment orientation and training programs to 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 , the applicable provisions 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.Ohio Admin. Code 3701-83-53
Effective: 7/15/2022
Five Year Review (FYR) Dates: 4/29/2022 and 07/15/2027
Promulgated Under: 119.03
Statutory Authority: 3702.13, 3702.30
Rule Amplifies: 3702.12, 3702.13, 3702.30
Prior Effective Dates: 01/13/1996, 09/01/2003, 07/01/2016