Radiation Protection Services: Amended X-ray and tanning operations and training rules; radiopharmaceutical licensing and labeling
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Permanent administrative rules amending Oregon Health Authority radiation protection requirements governing X-ray systems, tanning operations training, and special licensing requirements for manufacture, distribution, and preparation of radiopharmaceutical drugs; affects licensees, pharmacies, nuclear pharmacies, manufacturers, assemblers, and radiation work operators in Oregon regulated under OAR chapter 333 divisions 102, 106, 116, and related rules.
OAR 333-102-0285 is amended by correcting a Nuclear Regulatory Commission regulation reference from 21 CFR 207.20 to 21 CFR 207.17.
OAR 333-106-0005 definition of 'supervision' is updated to include responsibility to direct radiation work being performed in addition to routinely reviewing and monitoring work.
Detailed special requirements for a specific license to manufacture, assemble, repair or distribute commodities containing radioactive material, including conditions for radiopharmaceutical drug commercial distribution and labeling requirements.
Non-radiologist practitioners must receive an Oregon Health Authority approved fluoroscopy training course to operate a fluoroscopy machine or when supervising the fluoroscopy operator.
Doctors of Veterinary Medicine licensed in Oregon or veterinary technicians certified by the Oregon Veterinary Medical Examination Board may operate fluoroscopy machines for veterinary patients after completing an Authority-approved fluoroscopy course and the manufacturer's application training.
The rule specifies detailed required training topics and elements for all fluoroscopy operators (principles, radiation units, outputs, dose reduction, protective devices, monitoring, biological effects, applicable regulations).
Allows use of a rectangular collimator with a positioning indicating device and requires installation by an Oregon Health Authority licensed vendor; removes requirement to apply a leaded thyroid collar to pediatric patients when certain collimator/PID requirements are met.
Reduces the documented clinical CT experience required for qualified CT medical physicists from three years to 200 hours within a two-year period.
Allows veterinarians and certified veterinary technicians to operate veterinary CT systems for animal patients if they complete an OHA-approved CT course and manufacturer's application training.
Adds and clarifies reporting requirements for medical events, including specific dose thresholds, timelines for telephone and written reports, and notification obligations to patients and referring physicians.
Includes maximum timer interval rules, annual testing/records for timers and emergency shut-offs, and prescriptive exposure schedules by Fitzpatrick skin type.
Coverage Criteria and Operational Rules
Radiopharmaceutical licensing, labeling, instrumentation, and personnel requirements
Requirements for applicants and licensees involved in preparation, manufacture, or transfer of radiopharmaceutical drugs for commercial distribution:
ALL of the following
ONE of
- Applicant is registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.2017(a).
- Applicant is registered or licensed with a state agency as a drug manufacturer.
- Applicant is licensed as a pharmacy by a state Board of Pharmacy.
- Applicant is operating as a nuclear pharmacy within a federal medical institution.
- Applicant is a Positron Emission Tomography (PET) drug production facility registered with a state agency.
ALL of the following
- Applicant must submit information on the radionuclide, chemical and physical form, maximum activity per vial/syringe/generator/other container, and the shielding provided by the packaging to show appropriateness for safe handling and storage by medical use licensees.
ALL of the following
- A label must be affixed to each transport radiation shield (lead, glass, plastic, or other material) and must include the radiation symbol and the words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL; the name of the radiopharmaceutical drug or its abbreviation; and the quantity of radioactivity at a specified date and time (time may be omitted for radiopharmaceuticals with half-life greater than 100 days).
- A label must be affixed to each syringe, vial, or other container used to hold a radiopharmaceutical drug transferred for commercial distribution and the label must include an identifier that ensures correlation with the transport radiation shield label.
ALL of the following
- Licensees shall possess and use instrumentation to measure the radioactivity of radiopharmaceutical drugs and shall have procedures for use of the instrumentation.
- The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radiopharmaceutical drugs prior to transfer for commercial distribution.
- Instruments shall be tested before initial use, periodically, and following repair for accuracy, linearity, and geometry dependence as appropriate; instruments shall be checked for constancy and proper operation at the beginning of each day of use; and adjustments made when necessary.
ALL of the following
- Nothing in this rule relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radiopharmaceutical drugs.
Fluoroscopy operator coverage and qualification rules
Training, qualification, and supervision rules for operators of fluoroscopic X-ray systems:
ALL of the following
- X-ray production in fluoroscopic mode must be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure; when recording serial images the fluoroscopist shall be able to terminate exposures at any time though means may permit completion of a single exposure in a series.
ALL of the following
- Proper training must include, at minimum, topics such as: principles and operation of the fluoroscopic machine (generating X-rays, kVp and mA, image intensification, high level control vs standard mode, magnification, Automatic Brightness Control, pulsed vs continuous dose rates, image recording modes, imaging systems, contrast/noise/resolution); radiation units (traditional and SI units, Dose Area Product); typical fluoroscopic outputs (patient skin entrance dose, standard and high-level dose rates); dose reduction techniques (collimation, tube/intensifier placement, patient size/technique selection, grid use, last image hold, additional filtration, gantry angles, spacer cone, pulsed fluoroscopy); factors affecting personnel dose; protective devices; radiation exposure monitoring; biological effects; and applicable federal and Oregon rules.
WHOSE TRAINING IS CONSIDERED MET
- Radiologists currently licensed in Oregon are considered to have met the training requirements.
- Non-radiologist practitioners meet requirements if they have completed an Authority-approved training resource that meets the specified curriculum or have been operating fluoroscopic equipment prior to April 11, 2005.
- Radiologic technologists with a permanent or temporary license from the Oregon Board of Medical Imaging (OBMI), physician associates with a fluoroscopy permit, radiology physician's assistants (R.P.A.s) and registered radiology assistants (R.R.A.s) licensed by OBMI, and students in approved Radiologic Technology programs are considered to have met training requirements.
- For veterinary imaging only: Doctors of Veterinary Medicine licensed by the Oregon Veterinary Medical Examination Board or veterinary technicians certified by that board may operate fluoroscopy for veterinary patients only after successfully completing an Authority-approved fluoroscopy course and the manufacturer's application training as defined in OAR 333-106-0005.
ALL of the following
- Radiologists may operate fluoroscopic equipment without supervision; a non-radiologist practitioner physically present in the room during fluoroscopy must have an Authority-approved fluoroscopy training when operating the machine.
- (See rule text for additional conditions around supervision, on-site practical evaluation, and annual program review obligations where applicable.)
ALL of the following
- Facilities must record cumulative fluoroscopic on-time per exam, establish benchmarks across procedure categories, perform QA studies at intervals not exceeding 12 months, and take corrective action when benchmarks are exceeded more than 10% of the time performed.
Operational criteria for X-ray and CT practices
Operational requirements and exceptions for intraoral radiography, handheld units, CT practice, and related equipment controls:
ALL of the following
- Intraoral X-ray systems must provide means to limit source-to-skin distance (SSD) to not less than 18 cm. If minimum SSD is >= 18 cm, X-ray field at minimum SSD must be containable in a circle/rectangular cone no more than 7 cm diameter; if SSD < 18 cm, maximum diameter is 6 cm.
- When using a rectangular collimator a positioning indicating device (PID) must be used for all exposures and all rectangular collimators must be installed by an Oregon Health Authority licensed vendor.
ALL of the following
- All pediatric patients shall wear a 0.25 mm lead equivalent thyroid collar during intraoral X-ray exposures unless the registrant meets the rectangular collimator with PID installation requirements specified in the rule, in which case the thyroid collar is not required for pediatric patients.
ALL of the following
- Means shall be provided to control radiation exposure via adjustment of exposure time (s, ms), pulses, current/mA, mAs, or kVp. Exposure initiation must be deliberate by the operator; it shall not be possible to make an exposure when the timer is set to 0 or off; and exposure indication must be visible from the operator's protected position.
- Accuracy and reproducibility: deviation of technique factors for kVp and exposure time shall not exceed manufacturer-specified limits; dental X-ray machines with fixed kVp <55 kVp shall not be used; patient and film holding devices shall be used when techniques permit; tube housing and PID shall not be hand-held during exposure.
ALL of the following
- Registrant must secure and store units appropriately, report lost or stolen units within 72 hours, and ensure hand-held units have a permanently attached 0.25 mm lead equivalent backscatter shield, minimum 60 kVp and 2.0 mA, appropriate receptor speed or digital receptor, and documented operator and application-specific training.
ALL of the following
- To be a qualified CT medical physicist for surveys or consultative services, an individual with a relevant graduate degree must have 200 hours of documented clinical CT experience within two years (reduced from prior three years).
ALL of the following
- Administrative controls include use of patient and film holding devices when techniques permit, prohibition on hand-held tube housing and PID during exposure, and adherence to beam-size requirements; facilities must implement QA, benchmarking and corrective action procedures as specified in fluoroscopy rules.
Medical event reporting and CT medical physicist requalification
Reporting, notification, and requalification requirements for medical events and CT medical physicists:
ALL of the following
- Licensee must report any medical event (except specified patient intervention events) meeting dose thresholds or deviations: effective dose equivalent difference > 0.05 Sv (5 rem); organ/tissue dose > 0.5 Sv (50 rem); shallow dose equivalent to skin > 0.5 Sv (50 rem); total dose differing from prescribed dose by 20% or more; or fractionated dose for a single fraction differing by 50% or more; and other listed scenarios (wrong drug, wrong route, wrong individual, leaking sealed source causing specified doses).
ALL of the following
- Licensee must notify the Oregon Health Authority by telephone no later than the next calendar day after discovery of the medical event and submit a written report within 15 days including licensee name, prescribing physician, brief description of the event, why it occurred, effect on the individual(s), actions taken or planned to prevent recurrence, and certification regarding patient notification. The written report must not contain identifying patient information.
ALL of the following
- Licensee must notify the referring physician and the individual (or responsible relative/guardian) no later than 24 hours after discovery unless the referring physician elects to inform or deems notification harmful; if unreachable within 24 hours, notify as soon as possible thereafter. Licensee must maintain an annotated copy of the written report including the individual's name and identification number or SSN and provide an annotated copy to the referring physician within 15 days.
ALL of the following
- Re-establishment procedures apply for CT medical physicists who fail to maintain continuing experience or education; continuing experience requires evaluating at least two CT scanners in the prior 24-month period and continuing education requirements include at least 15 CME units (half category 1) in the prior 36 months as specified in rule.
ALL of the following
- These reporting and notification obligations align with specified dose thresholds and timelines; see rule text for full enumerated conditions and exceptions.
Tanning operations, training, consumer protections, and equipment
Operational, training, consumer protection, and equipment requirements for tanning facilities and operators:
ALL of the following
- Registrant shall ensure tanning devices are operated only while an adequately trained operator is present at the facility; all operators of registered tanning devices must successfully complete an Oregon Health Authority approved tanning training course prior to commencement of operations.
- Course approval requires submission of a curriculum covering enumerated topics including ultraviolet radiation, the skin, tanning process, risks of overexposure, minimal erythemal/melanogenic dose, skincare, suitability determination, tanning lamps, Fitzpatrick Skin Type utilization, recordkeeping, injury recognition/reporting, timer setting, protective eyewear instruction, sanitizing devices, FDA/FTC regulations, Oregon rules, and any other Authority-determined topics.
ALL of the following
- No person under 18 may use a tanning device without a physician medical recommendation and ID (see rule text); facilities must determine and record client Fitzpatrick Skin Type at initial visit, maintain exposure records, provide lists of common photosensitizing agents, and post/maintain manufacturer's recommended exposure schedule as required.
ALL of the following
- Registrant shall use only tanning devices manufactured in accordance with 21 CFR Part 1040, Section 1040.20; electrical servicing and repairs to tanning device electrical supply must be performed by a State of Oregon licensed electrician and State electrical codes must be observed; replacement lamps must be certified equivalent to OEM or per 21 CFR 1040.20 and used lamps must be disposed to prevent unauthorized use.
ALL of the following
- Each tanning device shall have a timer that complies with 21 CFR 1040.20(c)(2); maximum timer interval shall not exceed manufacturer recommendation or 20 minutes, whichever is less; timers shall be controlled by a trained operator via remote timer control; each timer must be functional and accurate to within ±10%; timers and emergency shut-offs must be checked and recorded annually; functional emergency shut-off must be provided allowing customer manual termination as required by 21 CFR 1040.20(c)(3).
ALL of the following
- Facilities shall use prescribed exposure schedules by Fitzpatrick skin type (detailed week-by-week minutes and weekly maintenance times) and must affix a copy of the exposure schedule to the device and maintain a copy at the timer controls.
Regulatory References, Codes, and Numeric Standards
| 21 CFR 207.17 | Corrected NRC regulation reference for drug establishment registration/manufacture |
| No explicit CPT/HCPCS/ICD codes provided in this document excerpt. |
| 21 CFR 1040.20 | Federal manufacturing and labeling requirements for sunlamp products and ultraviolet lamps intended for use in sunlamp products; referenced for tanning device manufacture and labeling requirements. |
Provider Actions, Authorizations, and Operational Responsibilities
Specific license applications must show registration/licensure, radionuclide/packaging details, labeled containers, and radioactivity measurement
Applicants for a specific license to prepare, manufacture, assemble, repair, or distribute radiopharmaceutical drugs must demonstrate one of the enumerated registrations or licensures, provide detailed radionuclide and packaging information, commit to specified labeling, and maintain instrumentation and procedures to measure radioactivity prior to commercial distribution.
- Provide evidence of one of: FDA drug establishment registration per 21 CFR 207.2017(a); state drug manufacturer registration; state Board of Pharmacy licensure; operation as a nuclear pharmacy within a federal medical institution; or PET drug facility registration with a state agency. [[do not include chunk refs in body]]
- Submit radionuclide, chemical/physical form, maximum activity per container, and packaging shielding information to show safe handling and storage.
- Affix labels to transport shields and to each syringe, vial, or other container that include the radiation symbol, words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL, the drug name or abbreviation, and the quantity of radioactivity at a specified date and time (time may be omitted if half-life > 100 days).
- Possess and use instrumentation to measure radioactivity and maintain procedures for its use; measure radioactivity in dosages prior to transfer for commercial distribution.
Complete OHA-approved fluoroscopy course before operating or supervising
Non-radiologist practitioners must complete an Oregon Health Authority–approved fluoroscopy training course before operating a fluoroscopy machine or while supervising a fluoroscopy operator; veterinarians and certified veterinary technicians may operate veterinary fluoroscopy only after completing the Authority-approved course plus the manufacturer's application training.
- Authority-approved fluoroscopy course is required for non-radiologist practitioners to operate or supervise fluoroscopy.
- Doctors of Veterinary Medicine and veterinary technicians certified by the Oregon Veterinary Medical Examining Board must complete the Authority fluoroscopy course and manufacturer's application training to operate for veterinary patients.
Adhere to supervision tiers and required annual program review for fluoroscopy operators
Follow the rule-defined supervision levels and training steps: radiologists may operate fluoroscopy unsupervised; non-radiologist practitioners present in the room must have Authority-approved fluoroscopy training; trained non-radiologist practitioners may operate without supervision only if the registrant arranges radiologist or medical/health physicist assistance for policy development, on-site practical evaluation, and an annual program review.
- Radiologists: may operate fluoroscopic equipment with no supervision.
- Non-radiologist practitioners physically present during fluoroscopy: must have Authority-approved fluoroscopy training to operate or supervise.
- Trained non-radiologist practitioners may operate unsupervised only if the registrant secures radiologist or medical/health physicist assistance to develop policies/procedures, conduct on-site practical evaluations, and perform at least annual program reviews (including QA on-times and equipment condition).
- Other categories (RTs, APRNs with permits, PAs, students) have specified supervisory arrangements per rule.
Install rectangular collimators via licensed vendor, use PID, meet SSD/field-size limits — pediatric thyroid collar exception if requirements met
Dental providers must ensure intraoral X-ray systems meet SSD and field-size limits, use a PID when employing a rectangular collimator, and have all rectangular collimators installed by an Authority-licensed vendor; registrants meeting the specified collimator/PID installation requirements are not required to apply a 0.25 mm lead-equivalent pediatric thyroid collar during intraoral exposures.
- Maintain minimum source-to-skin distance (SSD) of 18 cm where stipulated; maximum field diameter at minimum SSD: 7 cm (SSD ≥ 18 cm) or 6 cm (SSD < 18 cm).
- Use a positioning indicating device (PID) for all exposures with a rectangular collimator.
- All rectangular collimators must be installed by an Oregon Health Authority licensed vendor.
- Pediatric patients must wear a 0.25 mm lead-equivalent thyroid collar unless the registrant meets paragraphs (2)(b)(A) and (B) (rectangular collimator with PID installed by licensed vendor), in which case the collar is not required.
Secure hand-held units, report loss within 72 hours, use approved receptors/shields, meet kVp/mA and training requirements
For hand-held dental X-ray units, registrants must secure and store devices when not in use, report loss/theft to the Authority within 72 hours, use approved receptors, equip units with a permanently attached 0.25 mm lead-equivalent backscatter shield, meet minimum kVp/mA performance, and ensure operators complete machine-specific application training documented as required.
- Provide security and safe storage; file a report with the Authority within 72 hours if a hand-held unit is lost or stolen.
- Use image receptors of speed class E/F, F or faster, or digitally acquired images (CR or DR).
- Unit must have a permanently attached 0.25 mm lead-equivalent backscatter shield with manufacturer documentation of design provided to the Authority prior to sale/distribution.
- Hand-held unit must be capable of minimum 60 kVp and 2.0 mA; units not meeting these subsections may not be sold, distributed, or used in Oregon.
- Operators must complete machine-specific application training per OAR 333-106-0055(9); training must be documented and include required diagrams, receptor holders, PID use, and immobilization practices.
Veterinarians and certified vet techs must complete OHA CT course plus manufacturer training before operating veterinary CT
Veterinary CT systems for imaging animal patients may be operated only by an Oregon-licensed DVM or veterinary technician certified by the Oregon Veterinary Medical Examining Board after the individual completes an Oregon Health Authority–approved CT course and the manufacturer's application training.
- Complete an OHA-approved CT course and the manufacturer's application training as defined in OAR 333-106-0005 before operating veterinary CT systems.
Complete OHA-approved tanning operator course before commencing operator duties; registrant must ensure trained operator presence
All tanning device operators must successfully complete an Oregon Health Authority–approved tanning training course before beginning operator duties; registrants must ensure an adequately trained operator is present during tanning operations.
- Approved course curricula must be submitted for approval and include topics such as UV radiation, skin typing, risks of overexposure, Fitzpatrick Skin Type utilization, exposure records, timer setting, protective eyewear, device sanitization, and relevant federal/state rules.
- Registrant responsibility: ensure only adequately trained operators are present when devices are operated.
Definitions and Terminology
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