ML19309F245
| ML19309F245 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/1980 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| References | |
| TASK-CC, TASK-SE SECY-80-026A, SECY-80-26A, NUDOCS 8004290072 | |
| Download: ML19309F245 (4) | |
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- O72 UNITED STATES February 26, 1980 NUCLEAR REGULATORY COMMISSION SECY-80-26A WASHINGTON, D. C. 20555 CONSENT CALENDAR ITEM For:
The Commissioners From:
Robert B. Minogue, Director, Office of Standards Development.
Thru:
William J. Dircks
/', d / DIM Acting Executive Director for Operations
Subject:
ADDENDUM TO SECY 80-26 " EFFECTIVE AMENDMENTS OF 10 CFR PART 35 TO REQUIRE REPORTING OF MISADMINISTRATIONS OF BY PRODUCT MATERIAL"
Purpose:
Update SECY-80-26 to reflect a change in the final misadministration reporting rule.
Discussion:
At the February 21, 1980 Commission briefing *on the subject rule, the staff asked the Commission to approve the attached change to 8 35.42 of Enclosure 1 to SECY-80-26.
In the attached Vu-graph the additions are underlined.
This change will clarify our intent not to require a licensee to notify a patient of a misadministration without first consulting the referring physician.
Also attached are pages 130 and 131 of Enclosure 4 'to SECY-80-26.
These pages, which address Chairman Ahearne's question about the basis. for defining a greater than 10% error in therapy as a misadministration, were accidently left out of the SECY-80-26 package.
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RobertB.Minogue,Directork Office of Standards Development Attachments:
Vu-graph of 6 35.42 change Pages 130 and 131 of Enclosure 4 Contact.
E. Pcdolak, OSD
- SECY NOTE:
In the absence 6f a quorum no final action was taken 443-5860 on this paper at the Commission briefing.
Commissioners are re-minded that comments or consent should still be provided to SECY.
For this purpose a new due date is established as c.o.b.
Wednesday, March 5, 1980.
I DISTRIBUTION Ccmmissioners Comnission Staff Offices Exec Dir for Operations ACRS Secretariat
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@ 35.ll2 REPORTS OF TilERAPY MISADMINISTRATIONS.
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(A) IMMEDI ATE TELEPil0NE REPORI. WilEN A...
(IF Tile REFERRING PflYSICIAN, PATIENT OR Tile PATIENT'S liESPONSIBLE d
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RELATIVE OR GUARDI AN CANNOT BE REACilED WITilIN 211 ii0uRS, Tile LICENSEE SilALL NOTIFY TilEM AS S00N AS PRACTICABLE. Tile I.ICENSEE IS NOT REQUIREll TO NOTIFY Tile PATIENT OR Tile PATIENT'S RESPONSIBLE RELATIVE OR 6
MABDIAN WITil0UT FIRST CONSULTING Tile REFERRING PilYSICIAN,ll0 WEVER, Tile LICENSEE SilALL NOT DELAY MEDICAL CARE FOR Tile PATIENT BECAUSE OF TilIS.)
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QUALITY ASSURANCE-TELETHERAPY Maximum Acceptable Errors - Total Dose in Various Tumors References prepared'by:
Bureau of Radiological Health /FDA Division of Radioactive Materials and Nuclear Medicine
... total doses for fractionated treatments...., in comparison with a standard treatment, can be expected to cause equal reactions in dose-limiting normal tissues.
Experience has indicated that, within certain limitations..., these relations are quite reliable for a number of tissues, and deviations by as little as 5 - 10% may result in significant increases in probability of late complications."
Barendsen, G.W.:
Current Topics in Radiation Research, Quart. 9, 101 (1973).
...it is strikingly evident that for fractionated radiation therapy dosimetry errors of the order of 10 percent would drastically alter therapy efficacy."
(p. 93)
"if this tolerance dose is inadvertently exceeded by a factor of 1.10, there can be a drastic increase in local necroses."
(p. 93)
Suit, M.D.:
Textbook of Radiotherapy, Ed. by G.H. Fletcher, Lea & Febiger, Co., Phila., 1966.
"... changes of less than 8 percent in specified dose can make significant clinical changes in the eventual outcome of treatment."
(p. 25)
Fletcher, G.H.:
Textbook of Radiotherapy, Ed. by G.H. Fletcher, Lea &
Febiger Co., Phila., 1966.
...the lesion frequency increased very rapidly above a given CRE value.
An increase of 7 percent for the CRE...thus caused an increase in the lesion frequency from 15 to 50 percent."
Svensson, R.,
et al.:
Radiation induced lesions of the brachial plexus correlated to the dose-time-fraction schedule.
Acta Radiol. 14, 288 (1975).
The authors interpreted radiobiological and clinical data to indicata that variations of 7 to 10% in dosa could be detected clinically.
Wambersie, A.,
et al.:
Precision dosimetrique requise en radiotherapie.
J. Belce Radiol., 52, 94 (1969).
"A 10% difference in prescribed dose yields a statistically significant difference in recurrent rate."
Morrison, R. and T.J. Deeley:
Clin. Radioloay, 13, 145 (1962).
"A 5% to 10% increase in the dose (delivered to the patient) over that determined as optimal through clinical experiences produces a severe increase in the incidence of radiation damage to normal tissues."
130
l Herring, D.R. and D.M.J. Compton:
The Degree of Precision Required in Radiation Dose Delivered in Cancer Radiotherapy.
Enviro-med. Reoort, EMI-215:
10 July 1970.
"Five percent'd'fferences in total dose delivered can cause a significant i
change in use and/or control of the disease."
Shukovs ky, L.J. :
Dose, time, volume relationships in squamous cell carcinoma of the supraglottic larynx.
Amer. J. Roent., 108, 27 (1970).
The recurrence rate in stage 3 tumors of the larynx varied markedly when the tumor dose was varied by +5%.
Complications also increased significantly above a certain tumor dose.
- Stewart, 1.G. and A.W. Jackson:
The steepness of the dose response curve both for tumor cure and normal tissue injury, Laryncoscoce 85, 1107 (1975).
"These inaccuracies (discrepancies in physical dosimetry, clinical dosimetry and daily patient set-ups - Ed.) may lead to errors in delivered tumor dose of such magnitude that might change the probability of local control appreciably."
- Karta, P.,
et al.:
Dose response curves and their implications in dosimetry.
Presentation at Amer. Soc. of Theraceutic Radiologists, Denver, CO, 1977.
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