ML20137Q791

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Discusses Regulation & Licensing of Technologists in Nuclear Medicine,Per Proposed Rev to 10CFR35.Choices Available Listed,Including Preclusion of Unlicensed Technologist from Handling Matl
ML20137Q791
Person / Time
Issue date: 09/16/1982
From: Klucsik J
NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD)
To: Lieberman J
NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD)
Shared Package
ML20136D915 List: ... further results
References
FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230261
Download: ML20137Q791 (3)
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NOTE FOR: Jim Lieberman, ELD JP0 Q-3 -

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John Klucsik, ELD r* - .

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SUBJECT:

REGULATION AND CENSING OF TECHNOLOGISTS IN NUCLEAR MEDICINE . . _ _

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In our recent phone conversation we discussed portions of D the proposed Part 35 which deal with the activities of unlicensed medical technologists and the supervising ~

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L physicians who would be identified on a hospital license. I understand your concern to be over the proposed rula's-recognition of the technologist's activities and the.

imposition of regulatory requirements upon the technologist -

and the authorized (physician) user of byproduct material, t ,

rather than,upon the (hospital) licensee.

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Proposed section 35.2(a) includes the standard prohibition against handling material except in accordance with a - - -

license. If nothing further were said, several choices would be available:

1. The unlicensed technologist could be precluded from handling material;
2. Each license could expressly authorize material-Q'cq.3 i-g- handling by identified technologists; C:3..

W '. 3. Each license could be interpreted to authorize or could M's expressly authorize material-handling by any agent of .V;

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The regulations could expressly authorize "

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material-handling by any agent of the licenseer or .

- 4 5.. The segulations could expressly authorize material-handling by any agent of the authorized -

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- - (physician) user under his supervision. g.,--

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Q.- Option 5 is the approach embodied in the proposed revision of Part 35. I understand option 3 to be the one you favor.

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.G CONTACT: 8509230261 B50906 d' a 7

7- 43295 PDR PR ~3 35 50FR30616 PDR

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Jim Lieberman 2 September 16, 1982 3 ,

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X.. Option 1 would disrupt the delivery of nuclear medicine !i p: -

services. Option 2 would be administrative 1y cumbersome and a 7 -

as a practical matter would not work (although this is the .'

$.  :. . system which is and would continue to be used for _

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$. ..i physicians). /" N !;

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Optio'ns 3 and 4'would follow the model used in reactor licensing. The licenses would be responsible for the acts ,

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of his agents. This approach will work in the medical

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setting-if the agency . relationships there are.the same as ,

5 those in the utility setting. Often they are not.

T. Frequently, the hospital is the licensee.. Physicians eho ,

- are not on the hospital staff (are not agents of the e I

licensee) may have practice privileges at th'e hospital and may be identified on the hospital's license as persons authorized to perform nuclear medicine procedures there.

The technologist may be on the hospital staff but will take .

direction from the independent physician. (The technaiagist f may be a borrowed servant when carrying out the independent physician's orders). , ,

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Options 3 an'd 4 would place civil liability upon the *

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licensee hospital for actions of its borrowed servant, taken

  • . under the direction of a physician who was performing nk -

service for the hospital and whom the hospital could control only by denial of his practice privileges. The principal drafters of the proposed revision of Part 35 believe that fixing liability upon a licensee who may have little practical control over how byproduct material is

'. - administered to patients will not result in the desired 9j r patient and worker safety regardless of the level of q,g - : enforcement activity or the magnitude of the penalty 4 .g,; . . ; imposed. . , f' ,

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I believe that relying on an agency. relationship between the S

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violator and the licensee may present substantial evidentiary problems. One would have to establish the uQ-#

e agency relationship between the licensee hospital and the -

k.b. . - authorized user physician (which may not exist); and between ,

the licensee hospital and the technologist (which may not f*t M.. exist. if the technologist is a borrowed servant or if the 64; s M- technologist is supplied by an independent nuclear medicine "'?

!4iif'I' ~ service)'. These problems are compounded if the licensee is (

such'an indepaa4=at service. Such a service would han absolutely no control over the authorized user (physician)

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- . regardless of whether he was on hospital staff or was en -

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independent practitioner.

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..; opti6h 5 avoids' at least some of these problems by placing p y!-

1pabilityatthepointofcontrol.

The authorized user

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M ._. Jim Lieberman 3 September 16, 1982 M...W x-- x- .

1 y' directs the technologist when the technologist is M. administering material. (See S 35.38). Where the licensee hEk is more likely to have direct control, the duty of f?p 2 . compliance is upon the licensee (see SS 35.53, 35.70).

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I understand you to have some reluctance to impose civil - ., . ,, f.

M '.l penalties upon impecunious technologists. You have noted 4

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. that radiographers are in a similar position and that we [

[ig ,' . there impose the penalty upon the licensee employer or jN. principal. There are two difforences. One is in.the agency d> . relationship discussed above. The other is in the effect of 9 noncompliance. A radiographer's noncompliance may result'in 3 overexposure of himself~ and a piece of pipe.' A medical technologist's or authorized user's noncompliance may result in overexposure of himself and the patient. The prihcipal drafters believe it appropriate to place liability squarely , '

upon those who have direct control over administration of material to patients. You should note that the duties placed directly upon authorized user physicians and supervised technologists relate only to the actual administrati,on of material to patients. See SS 35.200, 35.300, 35.400, 35.500. Other duties relating to surveys, calibrations,.etc., are generally imposed upon the licensee.

After you have had a chance to review the attached portions of the proposef Part 35, please give Bill Walker, FCML, a call to schedule a conference among the three of us, Leo Higgenbotham, IE, and members of Bill's task force as appropriate. Bill can be reached at X-74232.

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Attachment:

ja Portions ~of Proposed yf. Part.35 -

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. cc: W. Walker, FCML 4fY O.- N. McElroy, ORPBR ' ,g gi;  : L. Higgenbotham, IE ,4 .-:

M. T. Dorian, ELD _.hi 1 N-Q , **

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