Regulation .04 Inspections by the Secretary.
Regulation .04 Inspections by the Secretary.LinkCopy Citation
A.
The Secretary may verify compliance with licensing requirements through on-site random sample record reviews.
B.
For the purpose of verifying compliance, the Secretary shall have access to:
(1)
The facility or office where the equipment is located;
(2)
Patients' medical records, including image or scan records;
(3)
Quality assurance records, including peer review documentation;
(4)
Records documenting in-service training on use of the equipment;
(5)
Records verifying personnel training;
(6)
Equipment quality control and inspection records;
(7)
Radiation safety reports;
(8)
Records of referrals and evidence of appropriate use of equipment;
(9)
Policies and procedures that ensure safe operation of equipment; and
(10)
Qualifications of personnel:
(a)
Permitted to supervise use of the major medical equipment,
(b)
Permitted to operate the major medical equipment, and
(c)
Responsible for maintenance of the major medical equipment.