U.S. Nuclear Regulatory Commission

Request for OGC Interpretation of 10 CFR 35.25 (a), "Instructing the Supervised Individual"

HPPOS-303 PDR-9306220048

Title: 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