Section 457.300 - Quality assurance and control: General requirementsThe operator of a facility shall:
1. Establish and maintain a program of quality assurance in accordance with the provisions of 21 C.F.R. § 900.12 for each machine and all other equipment at the facility used for mammography.2. Ensure that: (a) The performance of the equipment is monitored;(b) The results of monitoring are analyzed to determine if there are any problems requiring correction;(c) The necessary corrective action is taken whenever the results of a test for quality assurance indicate that such action is required; and(d) If necessary corrective action is taken, the action is taken before any mammography is performed on the patient.3. Prepare and maintain a list which includes the name of each mammographer who is authorized to operate any machine which is under the operator's control.4. Except as otherwise provided in NAC 457.355, not allow a person who does not hold a mammographer's certificate to operate a machine under the operator's control.5. If the facility for mammography has more than one machine, ensure that a unique machine identifier is included in the information which appears on the edge of the film as it is exposed.6. Ensure that all quality assurance and quality control records are kept until:(a) The next annual inspection has been completed and the Health Division has determined that the facility is compliant; or(b) The tests for quality assurance have been performed two additional times at the required frequency and are within the applicable control limits, whichever is longer.Nev. Admin. Code § 457.300
Added to NAC by Bd. of Health, eff. 1-24-92; A 7-7-94; R033-06, 6-28-2006