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P MEMORANDUM FOR:
John G. Davis, Director Office of Nuclear Material Safety and Safeguards FROM:
. Thomas E. Murley, Regional Administrator, Region I
SUBJECT:
CONCURRENCE AND COMMENT ON COMMISSION PAPER:
QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE In R. Cunningham's December 24, 1986 memorandum, he requested our concurrence on the subject Commission Paper. Due to the short time schedule for this Com-1 mission Paper and the associated Rulemaking, we are providing both our concur-i
=rence and several comments that we feel are important to achieving the Commis-sion's objectives.
In addition, editorial comments relative to the Commission Paper' and its enclosures are included in the enclosure to this memorandum.
If it is not possible to incorporate comments 2 and 3 below at this time due to the tight schedule, we request that they be considered again along with the l
public's comments on this matter.
1.
We strongly agree with the statements in the Discussion section of the Commission Paper that "... the word ' negligence'... will not have a salutary effect..." and should be removed from future rulemaking.
In t
addition, we believe that an approach based on negligence will not lead to effective or efficient regulation.
The most effective -regulation and most efficient use of resources will come from. clearly specifying quality assurance or other performance requirements and applying firm enforcement action to those licensees who either circumvent or fail to implement the requirements.
i 2.
With regard to the training, guidance, and supervision of nuclear medicine and therapy technologists (Question 3 in Enclosure 3 to the Commission Paper), we believe that effective action can be.taken without waiting for the results of a study.
Since technologists actually take the physical actions which result in many. misadministration, positive actions in this area can be particularly effective. 'While many techno-logists are presently certified by professional organizations, the train-ing leading to such certification does.not include the specific policies and procedures followed by each individual medical employer. We believe that a training and testing program similar to that required of radio-graphers in Part 34 could be quickly implemented at little cost and that such a program would assure that each person who administers radioactive material or radiation to patients was instructed in the licensee's pro-cedures and license requirements and had demonstrated understanding of the-training by passing both practical and written examinations.
Periodic refresher training and retesting could also be required. Therefore, we recommend that the rule include a list of minimum subjects to be covered, a minimum number of classroom hours to administer the training, and a 8712020111 871201 PDR PR
.JS S2FR36942 PDR
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John G. Davis 2
JAN 0 S 1937 i
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requirement that the training be given and that appropriate written and practical examinations be passed prior to administering radioactive material or radiation to patients.
l 3.
In reference to the Response to Question 8 in Enclosure 3, while journal publications and information notices are useful in communicating information to the medical community, and should be continued, we should seek additional avenues, such as attendance and presentations at profes-sional meetings and seminars.
Further, the list shown in the Response does. not include any Information Notices relative to misadministration (such as IN 85-61 and 84-77).
We appreciate the opportunity to comment on the draft Commission Paper.
f' Thomas E. Murley Regional Administrator
Enclosure:
As Stated cc:
R. E. Cunningham, 'iMSS W. C. Parler, OGC E. Beckjord, RES P. G. Norry, ADM G. W. Kerr, SP J. M. Taylor, IE C. J. Heltemes, AEOD J. N. Grace, RII J. G. Keppler, RIII R. D. Martin, RIV J. B. Martin, RV i
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DEC 301986 j'
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I Barry Wessels, Ph.D.
Division of Radiation Oncology and Biophysics George Washington University Medical Center 901 23rd Street, N.W.
Washington, D.C.
20037 j
Dear Dr. Wessels:
This is to request permission for Commissioner Carr, his assistant Mrs.
Federline, Dr. Glenn of our Region I licensing and inspection office, and myself to visit your clinic to receive an overview of the science and technology of teletherapy and brachytherapy. This recuest is based on informal conver:ations I have had with you previously.
The Commission has planned to examine its regulations regarding the medical
.use of byproduct material. Seeing the application of its current regulations in the field setting will be of assistance to the Commission in that endeavor.
This will be an educational visit.
Our group will be under the direction of one of your employees, and will not interfere with the operation of the clinic or patients' rights to privacy and confidentiality.
The' visit will be on January 12.
Because we also plan to visit the nuclear medicine clinic, when selecting the best time for the visit to your clinic, please coordinate with Mr. Cianci of nuclear medicine.
Thank you for your assistance in this matter.
Sincerely, Original Signed By Norman L McElroy Norman L. McElroy Material Licensing Branch Division of Fuel Cycle and Material Safety DISTRIBUTION FC Central File NMSS r/f FCML r/f JHickey IMcElroy a JGlenn, Region I MFederline, OCM OFC:FCML g/V FCML
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- 12/9 /86 0FFICIAL RECORD COPY AJ
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