Nev. Admin. Code § 459.176 - Examination of machine; written record of findings; corrective action

1. An invasive intervention radiation machine must be examined to verify that the invasive intervention radiation machine is operating in accordance with the specifications of the manufacturer of the invasive intervention radiation machine and that the invasive intervention radiation machine satisfies the requirements of the standards set forth in 21 C.F.R. § 900.12(b) and 21 C.F.R. § 900.12(e) that would apply to the invasive intervention radiation machine if the invasive intervention radiation machine were used to perform mammography as defined in 21 C.F.R. § 900.2(aa):

(a) Before the invasive intervention radiation machine is placed into service and at least annually thereafter;

(b) After the invasive intervention radiation machine is disassembled and reassembled at the same or a new location; and

(c) After a major component of the invasive intervention radiation machine is changed or repaired.

2. The medical physicist performing the examination shall make a written record of his or her findings and submit the record to the registrant for an invasive intervention radiation machine within 30 days after the examination.

3. If the registrant for an invasive intervention radiation machine does not receive the written record within the period prescribed in subsection 2, the registrant shall remove the machine from service until he or she receives the record.

4. If the registrant for an invasive intervention radiation machine receives a written record pursuant to subsection 2 which indicates problems with the invasive intervention radiation machine requiring correction, the registrant shall ensure that the necessary corrective action is taken before the invasive intervention radiation machine is used to perform any examination on a patient.

Notes

Nev. Admin. Code § 459.176

Added to NAC by Bd. of Health by R021-18A, eff. 12/30/2019

NRS 459.201