OAR 333-116-1000
Report and Notification of a Medical Event

(1)

A licensee must report any medical event as defined in OAR 333-116-0020 (Definitions)(19), except for an event that results from patient intervention..

(2)

The licensee must notify by telephone the Authority no later than the next calendar day after discovery of the medical event.

(3)

The licensee must submit a written report to the Authority within 15 days after discovery of the medical event.

(a)

The written report must include:

(A)

The licensee’s name;

(B)

The name of the prescribing physician;

(C)

A brief description of the event;

(D)

Why the event occurred;

(E)

The effect, if any, on the individual(s) who received the administration;

(F)

What actions, if any, have been taken or are planned to prevent recurrence; and

(G)

Certification that the licensee notified the individual (or the individual’s responsible relative or guardian), and if not, why not.

(b)

The report may not contain the individual’s name or any other information that could lead to identification of the individual.

(4)

The licensee must provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee must notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this rule, the notification of the individual who is the subject of the medical event may be made instead to that individual’s responsible relative or guardian. If a verbal notification is made, the licensee must inform the individual, or appropriate responsible relative or guardian that a written description of the event can be obtained from the licensee upon request. The licensee must provide such a written description if requested.

(5)

Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual’s responsible relatives or guardians.

Source: Rule 333-116-1000 — Report and Notification of a Medical Event, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-116-1000.

333‑116‑0010
Purpose and Scope 333‑116‑0020
Definitions 333‑116‑0025
FDA, Other Federal, and State Requirements 333‑116‑0027
Implementation 333‑116‑0030
License Required 333‑116‑0035
Application for License, Amendment, or Renewal 333‑116‑0040
License Amendments 333‑116‑0045
Provisions for Research Involving Human Subjects. 333‑116‑0050
Notifications 333‑116‑0055
Exemptions Regarding Type a Specific Licenses of Broad Scope 333‑116‑0057
License Issuance 333‑116‑0059
Specific Exemptions 333‑116‑0090
Authority and Responsibilities for the Radiation Protection Program 333‑116‑0100
Supervision 333‑116‑0105
Written Directives 333‑116‑0107
Procedures for Administrations Requiring a Written Directive 333‑116‑0110
Visiting Authorized User 333‑116‑0120
Mobile Nuclear Medicine Service Administrative Requirements 333‑116‑0123
Radiation Safety Program Changes 333‑116‑0125
Quality Management Program 333‑116‑0140
Suppliers 333‑116‑0150
Quality Control of Imaging Equipment 333‑116‑0160
Possession, Use, Calibration and Check of Dose Calibrators 333‑116‑0165
Possession, Use Calibration, and Check of Instruments to Measure Dosages of Alpha- or Beta-emitting Radionuclides 333‑116‑0170
Calibration and Check of Survey Instrument 333‑116‑0180
Determination of Dosages of Unsealed Radioactive Material for Medical Use 333‑116‑0190
Authorization for Calibration and Reference Source 333‑116‑0200
Requirements for Possession of Sealed Sources and Brachytherapy Sources 333‑116‑0220
Labeling of Vials and Syringes 333‑116‑0250
Surveys for Contamination and Ambient Radiation Dose Rate 333‑116‑0255
Surveys Of Patients And Human Research Subjects Treated With A Remote Afterloader Unit 333‑116‑0260
Release of Patients Containing Therapeutic Quantities of Byproduct material or Permanent Implants 333‑116‑0280
Storage of Volatiles and Gases 333‑116‑0290
Decay-In-Storage 333‑116‑0300
Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required 333‑116‑0310
Possession of Survey Instrument 333‑116‑0320
Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required 333‑116‑0330
Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration 333‑116‑0340
Control of Aerosols and Gases 333‑116‑0350
Possession of Survey Instruments 333‑116‑0360
Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required 333‑116‑0370
Imaging and Localization: Safety Instruction 333‑116‑0380
Imaging and Localization: Safety Precautions 333‑116‑0390
Possession of Survey Instruments 333‑116‑0400
Use of Sealed Sources for Diagnosis 333‑116‑0410
Availability of Survey Instrument 333‑116‑0420
Use of Sources for Manual Brachytherapy 333‑116‑0425
Surveys After Source Implant and Removal 333‑116‑0430
Safety Instructions 333‑116‑0440
Safety Precaution 333‑116‑0445
Calibration Measurements of Brachytherapy Sources 333‑116‑0447
Decay of Strontium-90 Sources for Ophthalmic Treatments 333‑116‑0450
Brachytherapy Sources Inventory 333‑116‑0460
Release of Patients Treated with Temporary Implant 333‑116‑0470
Possession of Survey Instruments 333‑116‑0475
Therapy Related Computer Systems 333‑116‑0480
Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit 333‑116‑0485
Other Medical Uses of Byproduct Material or Radiation from Byproduct Material 333‑116‑0490
Installation, Maintenance, Adjustment and Repair 333‑116‑0495
Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units 333‑116‑0500
Amendment 333‑116‑0525
Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units 333‑116‑0530
Possession of Survey Instrument 333‑116‑0540
Radiation Monitoring Device 333‑116‑0550
Viewing System 333‑116‑0560
Dosimetry Equipment 333‑116‑0570
Full Calibration Measurement 333‑116‑0573
Full Calibration Measurements on Remote Afterloader Units 333‑116‑0577
Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units 333‑116‑0580
Periodic Spot-Checks for Teletherapy Units 333‑116‑0583
Periodic Spot-checks for Remote Afterloader Units 333‑116‑0585
Additional Technical Requirements for Mobile Remote Afterloader Units 333‑116‑0587
Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units 333‑116‑0590
Radiation Surveys Therapeutic Treatment Units 333‑116‑0600
Safety Checks and Five-year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units 333‑116‑0605
Therapy-Related Computer Systems 333‑116‑0610
Modification of Teletherapy Unit or Room Before Beginning a Treatment Program 333‑116‑0620
Reports of Teletherapy Surveys, Checks, Tests and Measurements 333‑116‑0640
Radiation Safety Officer Training and Experience Requirements 333‑116‑0650
Training for Experienced Radiation Safety Officer 333‑116‑0660
Training for Uptake, Dilution or Excretion Studies 333‑116‑0670
Training for Imaging and Localization Studies 333‑116‑0680
Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required 333‑116‑0683
Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 Gigabecquerels (33 millicuries) 333‑116‑0687
Training for Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater than 1.22 Gigabecquerels (33 millicuries) 333‑116‑0690
Training for Therapeutic Use of Brachytherapy Source 333‑116‑0700
Training for Ophthalmic Use of Strontium-90 333‑116‑0710
Training for Use of Sealed Sources for Diagnosis 333‑116‑0715
Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive 333‑116‑0720
Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units 333‑116‑0730
Training for Teletherapy or Brachytherapy Physicist 333‑116‑0740
Training for Experienced Authorized User, Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Nuclear Pharmacist or Authorized Nuclear Pharmacist 333‑116‑0750
Physician Training in a Three Month Program 333‑116‑0760
Recentness of Training 333‑116‑0800
Licensing and Registration of Positron Emission Tomography (PET) Facilities 333‑116‑0810
Supervision of PET Facilities 333‑116‑0820
Other Applicable Requirements 333‑116‑0830
Accelerator Facility Requirements 333‑116‑0840
Safety Considerations and Quality Management for PET Facilities 333‑116‑0850
Radiopharmacy and Radiochemical Production 333‑116‑0870
Rubidium-82 Generator 333‑116‑0880
Training and Experience for PET, PET/CT and SPECT/CT Personnel 333‑116‑0905
Training for Authorized Medical Physicist 333‑116‑0910
Training for an Authorized Nuclear Pharmacist 333‑116‑0915
Training for Experienced Nuclear Pharmacists 333‑116‑1000
Report and Notification of a Medical Event 333‑116‑1015
Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child 333‑116‑1030
Report Of A Leaking Source
Last Updated

Jun. 8, 2021

Rule 333-116-1000’s source at or​.us