ML20029E291

Responds to Requesting Review & Comment on Proposed Quality Mgt Rule

ML20029E291
Person / Time
Issue date:	05/13/1994
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Frazee T WASHINGTON, STATE OF
References
NUDOCS 9405180104
Download: ML20029E291 (4)

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e WASHINGTON, D C. 20555 0001 May 13, 1994 Mr. Terry Frazee, Supervisor Radioactive Materials Section Division of Radiation Protection Department of Health, LE-13 Airdustrial Center Building #5 P.O. Box 47827 Olympia, WA 98504-7827

Dear Mr. Frazee:

This is in response to your February 9,1994 letter to Mr. Bangart requesting a review and comment on your Quality Management (QM) Rule.

The following comments are offered for your consideration:

1.

WAC 246-239-022 and WAC 246-240-015 indicate that -

"a written directive is not required when an authorized user personally assays and administers the dosage provided the pertinent facts are recorded as otherwise required."

By not requiring a written directive there may be a problem with enforcement if a misadministration occurs. We recommend that you include a requirement for a written directive which would address this potential problem.

2.

Your proposed QM rule does not address 10 CFR 35.32 (b) (1) which requires that procedures be developed for reviewing the effectiveness of the QM program.

We recommend that you include this provision in your QM rule.

You should also be aware that the definitions in Part 35.2, which are equivalent to WAC 246-240-010(3)(c) and (5)(b)(iii), are being revised through the proposed final radiopharmacy rulemaking action. These changes to the Part 35 language are presented below referencing the corresponding section in Washington regulations:

Part 35.2 (WAC 246-240-010(3)(c))

"a teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by fifteen percent or more of the weekly dosage;" or Part 35.2 (WAC 246-240-010(5)(b)(iii))

"when the calculated weekly administered dose exceeds the weekly prescribed dose by thirty percent or more of the weekly prescribed dosage."

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llAY I 3 1994 We appreciate the opportunity to review your proposed QM rule amendment.

If you have any questions, please call me or Lloyd Bolling on (301) 504-2327.

cerely, k

x Paul H. Lohaus, Deputy Director Office of State Programs H

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Terry Frazee 2

1. Ay 131994 We appreciate the opportunity to review your proposed QM rule amendment.

If you have any questions, please call me or Lloyd Bolling on (301) 504-2327.

Sincerely, (

Paul H.

ohaus, Deputy Director Office of State Programs Distribution:

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Mr. Terry Frazee, Supervisor Radioactive Materials Section Division of Radiation Protection Department of Health, LE-13 Airdustrial Center Building #5 P.O. Box 47827 Olympia, WA 98504-7827

Dear Mr. Frazee:

1 This is in response to your letter 'to Mr. Bangart requesting a review and comment on your Quality Management Rule.

Our review of the proposed rule did not detect any changes or omissions that would make the rule incompatible with that of the NRC.

We appreciate the opportunity to review this proposed rule.

If you have any questions, please contact me or Lloyd Bolling at 301-504-2327.

Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs Distribution:

Dir RF S-29 RBangart PLohaus LBolling JGlenn OGC WA File

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