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NUREG-1537, Part 2 - NRC

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CHAEW 16<br />

* Requirements for reporting misadministrations to <strong>NRC</strong> should be<br />

discussed. The <strong>NRC</strong> staff has accepted 24-hour oral notice with a written<br />

report within 15 days. Records of recordable events should be maintained<br />

for 5 years.<br />

* The applicant should discuss control of repair, maintenance, and<br />

modification activities.<br />

* The applicant should discuss training requirements as outlined in the format<br />

and content guide.<br />

* The applicant should submit a quality management program that covers the<br />

topics outlined in the format and content guide.<br />

* The applicant should discuss other procedures pertaining to treatment that<br />

involve the reactor. This includes measurements of boron content in blood<br />

and tissue. Requirements for calibration and surveillance of equipment to<br />

ensure proper operability should be stated.<br />

If the primary scram method is out of service in the medical therapy treatment<br />

facility control area; the applicant may propose the temporary use of the<br />

communications link with the control room to ask the operator to scram the<br />

reactor. If the primary method to indicate the status of the systems used to cut off K)<br />

the beam is out of service, the applicant may propose a temporary alternative. If<br />

the radiation monitor in the medical therapy treatment room is out of service, the<br />

applicant may propose a temporary alternative method of monitoring radiation in<br />

the room. In these cases, the use of the temporary alternative should be limited to<br />

a short period of time (e.g., no more than 10 working days).<br />

Review Procedues<br />

If the applicant needs to make major modifications to the reactor facility that<br />

require the issuance of a construction permit, the reviewer should use other<br />

applicable chapters of this standard review plan to evaluate those changes. For<br />

example, changes to the reactor core would be reviewed using Chapter 4, 'Reactor<br />

Description." The reviewer should consult the Medical, Academic, and<br />

Commercial Use Safety Branch in the Office of Nuclear Material Safety and<br />

Safeguards during the review of the application, particularly for the quality<br />

management program and aspects of the application that deal with medical issues<br />

(e.g., definitions of recordable events and misadministrations). The appendix to<br />

this chapter in the format and content guide is a copy of the license amendment for<br />

conducting BNCT at the Massachusetts Institute of Technology.<br />

NUEG 157 _6- PAR 2<br />

.,_<br />

RV<br />

<strong>NUREG</strong>- <strong>1537</strong>, PART 2 16-8 REV. O. 2/96<br />

X-<br />

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