OAR 333-106-0369
Computed Tomography X-ray Systems: Report and Notification of a CT Medical Event

(1)

A CT facility shall notify the Authority within 48 hours of any CT medical event in which a patient who has undergone a CT study has incurred a deterministic radiation injury, such as epilation or erythema.

(2)

The registrant shall submit a written report to the Authority within 30 days after the CT medical event is discovered.

(3)

The written report shall include all of the following:

(a)

The registrant’s name, address, facility registration number, and machine registration tag number as they appear on the registration certificate;

(b)

The name of the individual who determined a CT medical event occurred;

(c)

The dates of occurrence and discovery of the CT medical event;

(d)

A narrative description of the CT medical event, including an estimated dose to the patient, if possible, and body part involved;

(e)

The cause of the CT medical event;

(f)

The effect on the individual who received the exposure;

(g)

A narrative detailing corrective action taken or planned to prevent a recurrence;

(h)

Certification that the registrant notified the individual or the individual’s responsible relative or guardian and, if not, why not; and

(i)

The name and signature of the person preparing the report.

(4)

The report shall not contain the name of the individual who is the subject of the CT medical event or any other information that could lead to identification of the individual.

(5)

The registrant shall consult with the referring physician prior to notifying the individual that they were involved in a CT medical event.

(a)

The registrant shall ensure that the individual was notified of the CT medical event no later than one week after the discovery unless unforeseen circumstances exist.

(b)

The registrant shall not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the CT medical event.

(c)

If verbal notification is necessary, the registrant shall inform the individual or legal guardian that a written description of the CT medical event can be obtained from the registrant.

Source: Rule 333-106-0369 — Computed Tomography X-ray Systems: Report and Notification of a CT Medical Event, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-106-0369.

333‑106‑0001
Purpose and Scope 333‑106‑0005
Definitions 333‑106‑0010
Administrative Controls 333‑106‑0015
General Requirements: Technique Chart 333‑106‑0020
General Requirements: Written Rules and Procedures 333‑106‑0025
General Requirements: Protection of Patients and Personnel 333‑106‑0035
General Requirements: Deliberate Exposures Restricted 333‑106‑0040
General Requirements: Patient Holding and Restraint 333‑106‑0045
General Requirements: Use of Best Procedures and Equipment 333‑106‑0050
General Requirements: Personnel Monitoring 333‑106‑0055
General Requirements: X-ray Operator Training 333‑106‑0060
General Requirements: Radiation Use and Safety Instructor Qualifications 333‑106‑0101
General Requirements: Diagnostic X-ray Systems 333‑106‑0105
General Requirements: Information and Maintenance Record and Associated Information 333‑106‑0110
General Requirements: Plan Review 333‑106‑0120
General Requirements: Information on Radiation Shielding for Plan Reviews — Optional 333‑106‑0130
General Requirements: Design Requirements for an Operator’s Booth 333‑106‑0201
Fluoroscopic X-ray Systems 333‑106‑0205
Fluoroscopic X-ray Systems Requirements: Activation of the Fluoroscopic Tube 333‑106‑0210
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Entrance Exposure Rates 333‑106‑0215
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Barrier Transmitted Radiation Rate Limits 333‑106‑0220
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Indication of Potential and Current 333‑106‑0225
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Source-to-Skin Distance 333‑106‑0230
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Timer 333‑106‑0235
Fluoroscopic X-ray Systems Requirements: Mobile Fluoroscopes 333‑106‑0240
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Control of Scattered Radiation 333‑106‑0245
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Radiation Therapy Simulation Systems 333‑106‑0301
Additional Requirements for Radiographic Machines: Beam Limitation for Radiographic Systems Other Than Fluoroscopic, Dental Intraoral, Veterinary Systems, or Computed Tomography(CT) 333‑106‑0305
Additional Requirements for Radiographic Machines: Radiation Exposure Control Devices 333‑106‑0310
Additional Requirements for Radiographic Machines: Source-to-Skin Distance 333‑106‑0315
Additional Requirements for Radiographic Machines: Exposure Reproducibility 333‑106‑0320
Additional Requirements for Radiographic Machines: Radiation from Capacitor Energy Storage Equipment in Standby Status 333‑106‑0325
Additional Requirements for Radiographic Machines: Intraoral Dental Radiographic Systems 333‑106‑0345
Purpose and Scope 333‑106‑0350
Computed Tomography X-ray Systems: Definitions 333‑106‑0355
CT Equipment Requirements 333‑106‑0360
Computed Tomography X-ray Systems: Facility Design Requirements 333‑106‑0361
Computed Tomography X-ray Systems: Radiation Protection Surveys 333‑106‑0362
Computed Tomography X-ray Systems: Operating Procedures and Conditions of Operation 333‑106‑0363
Computed Tomography X-ray Systems: Quality Control Program 333‑106‑0364
Computed Tomography X-ray Systems: Initial and Annual Qualified CT Medical Physicist Scanner Performance Evaluations 333‑106‑0366
Computed Tomography X-ray Systems: Dose Limits 333‑106‑0367
Computed Tomography X-ray Systems: Records and Report Retention 333‑106‑0368
Computed Tomography X-ray Systems: Qualified CT Medical Physicist 333‑106‑0369
Computed Tomography X-ray Systems: Report and Notification of a CT Medical Event 333‑106‑0370
Computed Tomography X-ray Systems: Operator Requirements 333‑106‑0601
Veterinary X-ray Systems: Veterinary Medicine Radiographic Installations Additional Requirements 333‑106‑0700
Mammography Requirements: Mammography X-Ray Systems Definitions 333‑106‑0710
Mammography Requirements: Equipment Standards 333‑106‑0720
Mammography Requirements: Quality Assurance Program 333‑106‑0730
Mammography Requirements: Additional Requirements 333‑106‑0735
Mammography Requirements: Breast Density Notification 333‑106‑0750
Mammography Requirements: Mammography Personnel Qualifications
Last Updated

Jun. 8, 2021

Rule 333-106-0369’s source at or​.us