To improve operational efficiency, the Bureau of Radiological Health is transitioning to new inspection procedures which include performing unannounced inspections.
Regulation 61-64 X-Rays (Title B) Section 10.5 requires each registrant afford Department inspectors opportunity to inspect machines, activities, facilities, premises, and records at all reasonable times. Section 1.10 requires records to be readily available at the facility for Department review.
To assist the Bureau in conducting inspections as efficiently as possible, please ensure the following documents are readily available at all times:
- Records of equipment performance testing
- Records of personnel monitoring, if applicable
- Documentation that all x-ray operators have machine specific training on the facility's x-ray equipment
- SCRQSA certificates for x-ray operators, if applicable
Please refer to the following regulatory guides for more information on complying with Regulation 61-64 X-Rays (Title B):
The Bureau understands the importance of patient care and inspectors will continue to work with your staff to ensure minimal interruptions to your daily activities. You may assist in ensuring the continuity of your operations by maintaining an up-to-date X-Ray Facility General Information Form or Dental Facility General Information Form at your facility as the inspector will request the completed document upon their arrival.
MQSA policies require mammography inspectors provide advanced notification. Therefore, the mammography facilities will continue to be contacted prior to inspections.
If you have any questions, please contact the Department at 803-545-4400.