ML20127L733

Forwards Page 2 of Document, Quality Mgt Program for Generation of MITR-II Medical Therapy Facility Beam for Human Therapy, as Further Response to 921201 RAI

ML20127L733
Person / Time
Site:	MIT Nuclear Research Reactor
Issue date:	01/22/1993
From:	Bernard J MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
TAC-M82958, NUDOCS 9301270281
Download: ML20127L733 (2)

Text

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I NUCLEAR REACTOR LABORATORY b,b.+

AN INTERDEPARTMENTAL CENT ER OF \gj7 MASSACHUSETTS INSTITUTE OF TECHNOLOGY o K HAnUNG 1313 ANny Street. Cambroge, Mau 02139 4296 J A. BERNAnD. JR.

Director T elef ax No (617) 2531300 Directs of Reactor Operabons Teter No 92-1473 MIT CAM Tel No (617) 253 4202 January 22,1993 U.S Nuclear Regulatory Commission, ATTN: Document Control Desk Washington, D.C. 20555 Subject Funher Response to Request Dated 12 MIS 2 for Additional Infonnation (TAC No. M82958) Conceming Generation of Medical Therapy Facility Beam for iluman Therapy, l.icense No. R-37, Docket No. 50-20 Gentlemen:

On 12/22S2, the Massachusetts Institute of Technology submited, in their entirety, revised copies of proposed MITR Technical Specification No. 6.5, " Generation of Medical Therapy Facility Beam for iluman Therapy" and " Quality Management Program for Generation of MITR-il Medical Therapy Facility Beam for lluman Therapy." Also enclosed was the last page of existing Specification No. 7.13, " Plant Reporting Requirements." The revisions in those documents, which were denoted by italicized print, were made in response to the letter of I December 1992 from Mr. Alexander Adams, Jr.

(Project Manager NRR/PDNP) to Dr. John A. Bemard (Director of Reactor Operations, Mrl*). All changes requested in that letter were made. On 12/30S2, three further changes were requested. Revised coj ies of the above documents were therefore submitted at that time. One alditional change m the Quality Management Program has since been identified as desirable. Accordingly, page 2 of that document is hereby resubmitted. -

Sincerely,

% ct AL

/ohn J A. Bernard, Ph.D.

Director of Reactor Operations MIT Research Reactor JAB /gw

Enclosure:

Revision to paragraph 3(b)(i) of the proposed Quality Management Program cc: MITRSC (with enckwures)

USNRC. Project Manager, NRR/PDNP USNRC - Region ! . Chier, EfHoents Radia .on Protection Section (ERPS) d FRSSB/DRSS USNRC - Director, NRR/PDNP i

9301270201 930122 PDR ADOCK 05000020 a

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2-correct directive for the patient .in question, a copy of that directive shall be hand-deliveted to th.: MrrR Staff by the Staff of the medical use licenset who accompany the patient to MIT. This copy shall then be checked agaimt the most recent previous transmission. Any discrepancy shall be resolved by the medical us.e licensee prior to the initianon of patient irradiation.

(vi) The Di ector of the MIT Nuclear Reactor Laboratory, or his designate, will date and algn the ,vritten directive to verify that current and accurate beam characteristic parameters were provided to the NRC-approved medical use licensee and that the radiation flutnce desired i., the wrinen directive uns delivered. A copy of this signed directive shall be piovided to the medical use licensee within twentyfour hours of a treatment.

(b) Itior to each administration of any radiation, the patierd identity will be verified by more than one method as the individus) named ir the written directive. The MITNuclear Reactor Laboratory will use any two or more of Ihefollowing acceptable methods ofldentification:

(i) Self identifiution by patients who are conscious upon arrival at the M:T Research Reactor. Information provided by the parlent shall include any two of thefallowingt name, address, date of birth, or social security number. The irtformation provided by the patient is to be compared to the corresponding information in the patient's record.

(ii) llospital wrist band identification with the wrist band information to be compared to the corresponding information in the patient's record.

(iii) Visual identification against photographs pt vided with the written directive.

(iv) Other methods as specified in U.S. Nuclear Regulittory Commission Regulatory Guide 8.33," Quality Management Program."

(c) The plan of treatment is certified by the certified medical physicist to be in cecordance with the written directive. In this regard, the Massachusetts Institute of Technology is responsible for calibrating the output of the beam monitoring instrumentation versus dose in phantom and for providing a central axis dose versus depth profile. This information will then be used by personnel at the NRC-approved :nedical use licensee to ger,erate o plan of treatment. Conformance of the beam to its design characteri', tics is confirmed through t'ie measurements specified in MITR Technical Specification #6.5, " Generation of Medical 'lherapy Facility ' Beam for Human Therapy " The beam is characterized dosimetrical!y every six months (provision 14(b)), the beam monitors are calibrated every two years by a secondary calibration laboratory and their propu operation is verified semi annually (provision 14(c)), and calibration checks are made of the beam at least weekly for any week that the beam will be used for human therapy (provision 14(a)).

(d) Ilach administration of radiation is in accordance with the written directive subject to the tolerances established in provision 11 of MITR Technica' Specification #6.5, " Generation of Medical Therapy Beam for Human Therapy."

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