ML25104A060
| ML25104A060 | |
| Person / Time | |
|---|---|
| Issue date: | 04/10/2025 |
| From: | Solomon Sahle NRC/NMSS/DMSST/ASPB |
| To: | Schneider I State of CA, Dept of Public Health |
| References | |
| Download: ML25104A060 (1) | |
Text
California 25-12 LC Review Sheet License Condition Evaluation M-8 The licensee shall notify the Department in writing at least 30 days prior to the initiation of any of the actions listed below:
(a) Removal from a shielded room of a complete teletherapy unit which is not to be replaced.
(b) Removal from a shielded room of a complete teletherapy unit head which is not to be replaced.
Applicability:
02110: Medical Institution Broad 02300: Teletherapy
Background:
The NRC does not have an equivalent regulation or license condition.
California notes that this addresses 10 CFR 35.14, Notifications, however, this is not a required notification.
Discussion:
This license condition is administrative since it requires notification prior to a licensee taking an authorized action and does not impact health and safety or create any conflicts/gaps with NRC requirements.
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Conclusion:==
The NRC does not have any concerns regarding California imposing this additional administrative requirement.
O-7 Each human use of radioactive material performed under this license shall include the following responsibilities by a physician listed in Condition 12 of this license:
(a) Determination that the procedure to be used is appropriate to the patient, based on knowledge of the patients condition.
(b) Assuring that the appropriate radiopharmaceutical and other pharmaceutical are prescribed.
(c) Assuring the safety of the patient and the public in both the conduct of the exam and maintaining radiation health and safety.
(1) Assuring technologist certification and training (2) Camera and dose calibrator quality control (3) Supervision of actual procedure Applicability:
02220: Mobile Medical - Written Directive not required 02221: ??
Background:
N/A Discussion:
Many of the responsibilities in this LC are usually prescribed to the RSO per a delegation of authority. Other responsibilities are part of Part 35 (e.g., maintaining records or administrations, performing QC on dose calibrator).
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Conclusion:==
The NRC does not have a program code 02221 and CA. The word physician is vague and not in the regulation definitions.
California 25-12 LC Review Sheet (4) Preparation of reports (5) Interactions with technologist, patient, and referring physicians (6) Maintain records of administer activity (7) Supervise area surveys (8) Maintain records of procedures (9) Confirm that the procedure has been satisfactorily completed (d) The interpretation of the diagnostic data and communication of the results to the referring physicians in a timely and effective way.
J-7 The licensee shall maintain a current list of the names and titles of all individuals who act as radiographers and radiographers assistants. A radiographers assistant is any individual who assists a radiographer in the performance of radiographic operations. Individuals shall receive training pursuant to the Title 17, California Code of Regulations, Section 30333 (b) (1) and (2) prior to acting as radiographers assistant. A copy of this list shall be submitted to the following inspection agency within three (3) working days of any change in the list:
Applicability:
03310: Industrial Radiography - Fixed Location 03320: Industrial Radiography - Temporary Jobsites
Background:
NRC equivalent license condition states Licensed material shall only be used by, or under the supervision and in the physical presence of, individuals who have been designated in writing by the Radiation Safety Officer and have been trained: (A) As specified in the
[application/letter] dated [insert date]; and (B) In accordance with the provisions of 10 CFR 34.43 NRC definition of radiographers assistant: means any individual who under the direct supervision of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instruments in industrial radiography. [Compatibility Category B]
CA definition of radiographers assistant: means any individual who has met the requirements of sections 30333(b) or 30336.5(a)(1) and who must be under personal supervision as required by sections 30333(c) or 30336.1(o)
California 25-12 LC Review Sheet Discussion:
Condition J-7 requires that an industrial radiography licensee maintain a list of individuals currently authorized to be either a radiographer or a radiographers assistant. This condition partially meets the essential objective of the NRC equivalent condition (LC C-22 appears to address the remainder) and also imposes an additional administrative responsibility to submit the list to the Agreement State whenever it is revised.
While CAs condition references the training requirements for radiographer assistants it does not do so for radiographers.
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Conclusion:==
Radiographers assistant definition should be consistent with CA definition or be removed. Radiographer should be defined if assistant is.
J-9 Notwithstanding the authorized uses of radiographic sealed source, exposure device, source changer, or associated equipment which does not meet the requirements of the Title 17, California Code of Regulations, Section 30332, is prohibited except for purposes of storage, transfer and disposal.
Applicability:
03310: Industrial Radiography - Fixed Location 03320: Industrial Radiography - Temporary Jobsites
Background:
Notwithstanding paragraph (a)(1) of this section, equipment used in industrial radiographic operations need not comply with § 8.9.2(c) of the Endurance Test in American National Standards Institute N432-1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism.
Discussion:
Incorrect CFR is sited on CA letter. Section 30332 is similar to 10 CFR 34.20
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Conclusion:==
The NRC does not have any concerns regarding California imposing this additional requirement.
California 25-12 LC Review Sheet C-22 (a) Licensed material shall be used by, or under the supervision and in the physical presence of, individuals who have complied with the provisions of Title 17, California Code of Regulations (17 CCR), Section 30334 (c) or Section 30335.4.
(b) The following individual(s) meet the requirements of 17 CCR, Section 30333.05, or equivalent as approved by the Department, and are authorized to act as an Industrial Radiographer Trainer:
(1) [Radiographer Trainer Name]
Applicability:
03310: Industrial Radiography - Fixed Location 03320: Industrial Radiography - Temporary Jobsites
Background:
NRC equivalent license condition states that Has developed competence to use, under the personal supervision of the radiographer, the radiographic exposure devices, sealed sources, associated equipment, and radiation survey instruments that the assistant will use.
Discussion: C-22 (a) meets the requirements of the NRC. (b) is administrative.
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Conclusion:==
The NRC has no comments on the license condition.