Request for OGC Interpretation of 10 CFR 35.25 (a), "Instructing the Supervised Individual"
See the memorandum from S. A. Treby to J. E. Glenn dated February 1, 1991.
This was written in response to an NMSS memo requesting an OGC interpretation of the term "instruction" in 10 CFR 35.25 (a), including "a determination whether errors that result in a misadministration or performance error leading to a violation would be a violation of the supervision requirement in 10 CFR 35.25." The determination as to whether a particular incident violates the provisions of the regulations, in Section 35.25, for example, can only be made on a case-by-case basis, depending on the facts involved. Therefore, the following discussion is meant to provide general guidance only, in reference to the kinds of incidents described in the NMSS memo, and might not necessarily be dispositive when applied to an actual incident. HPPOS-303 contains a related topic.
OGC has considered the provisions of Section 35.25 and the relevant statements of consideration (SOC), and we agree that any error in the administration of the intended dosage of radiopharmaceutical or radiation that results in a misadministration or performance error would not necessarily be a violation of the supervision requirement. On the other hand, whether or not an administration of byproduct material is in accordance with the physician's directions, if there is a failure to follow the instructions of the supervising authorized user or the procedures of the RSO or to comply with the NRC regulations or license conditions, there would be a violation of Section 35.25.
The "term" instruction is not defined in Part 35. The SOC for Part 35 (51 FR 369322) discusses that term, in the context of responding to comments on the proposed rule, In particular, the SOC states, in the relevant part:
3. Instruction. Several commenters asked if instruction for workers had to be in classroom lecture format. The NRC recognizes that instruction can be in the form of lectures, laboratory exercise, audiovisual packages, printed handouts, preceptorials, or apprenticeships. The important point here is not the format of the instruction but rather that the instruction be retained and used by the worker. To help correct misunderstandings, an opportunity for questions and answers should be an integral portion of each instruction module.
The NRC did not address the frequency of review sessions because that judgement must be made on-site. If employees are performing all their assigned tasks correctly, there is no need to spent time reviewing procedures with the employees. If instruction has not been followed by regular use of the procedures taught, then review instruction is probably necessary. If an employee is unable to do things correctly, then review and continued close supervision, or reassignment, is necessary.
The SOC discusses Section 35.25, "Supervision", as follows (in relevant part):
The purpose of supervision is to provide assurance that technologists and physicians do not use byproduct materials in a manner that is contrary to the requirements of the license, the regulations or this is hazardous to the public health and safety .... NRC recognizes that medical practice is regulated differently in each state, but that, in the end, the physician is responsible for providing quality health care. A prescriptive definition that describes delegable tasks, timely response in case of untoward events, and training requirements that are suited for one setting may hinder the delivery of medical care in another setting. The authorized user physician identified on the license is responsible for delivering quality medical care, and is best situated to determine what tasks a certain physician or technologist is capable of performing.
Under the final regulation, a licensee may delegate to unnamed individuals performance of any task associated with the medical use of byproduct material, from package receipt through quality control, prescription, administration, interpretation or follow-up for individual clinical procedures, and radioactive waste disposal. The delegations must be consistent with other institutional requirements and the state's regulation of medicine .... The licensee can not delegate responsibility to supervised individuals. If a supervised individual, through misunderstanding, negligence, or commission, acts contrary to the requirements of the license, the regulations, or an order, the licensee remains responsible.
The NRC believes this strikes the best balance between its responsibility to assure the public health and safety and a physician's responsibility to deliver quality medical care.
Section 35.25 obviously requires that the supervised individual follow the instructions of the supervising authorized user, follow the procedures established by the RSO, and comply with the regulations and the license condition with respect to the use of byproduct material. If the supervised individual does not follow these instructions or procedures, or fails to comply with the regulations and the license conditions, then there would be a violation of Section 35.25. Furthermore, if the instruction or procedure is incorporated into the license, then there would be a violation of the license, which might be the more appropriate citation for enforcement action.
OGC does not interpret Section 35.25 so narrowly as to limit its scope only to a failure to follow a specific instruction, which if adhered to, would have prevented a misadministration or other incident. The language in Section 35.25 clearly requires that the supervised individual also follow certain procedures, regulations, and license conditions. A failure to follow any one of those would be a violation of Section 35.25. Thus, if there was a failure to follow the instruction of the supervising authorized user, the procedures of the RSO, or to comply with the regulations or license conditions, there would be a violation of Section 35.25.
OGC does not believe that any error in the administration of the intended dosage resulting in a misadministration or other incident, absent the failure to follow an instruction, or procedure or to comply with a regulation or license condition, is a violation of Section 35.25. Such an interpretation would negate the long standing position of the NRC that the occurrence of a misadministration is not, in and of itself, the basis for enforcement action, unless there is a failure to timely and properly report the misadministration as required in 10 CFR 35.33, or there is a violation of other applicable requirements, such as might be contained in a regulation or license condition.
Regulatory references: 10 CFR 35.25
Subject codes: 1.2, 1.4, 12.11, 12.19
Applicability: Byproduct Material
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