ML20249C730
| ML20249C730 | |
| Person / Time | |
|---|---|
| Issue date: | 06/25/1998 |
| From: | Combs F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Blough A, Dan Collins, Pederson C, Scarano R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| References | |
| SECY-97-288-C, SECY-98-042-C, SECY-98-42-C, NUDOCS 9807010113 | |
| Download: ML20249C730 (4) | |
Text
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~ MEMORANDUM TO: . A. Randolph Blough, Director i Division of Nuclear Materials Safety, RI !
Douglas M. Collins, Director Division of Nuclear Materials Safety, Ril Cynthia D. Pederson, Director Division of Nuclear Materials Safety, R!Il Ross A. Scarano, Director-4uclear Materials Safety, RIV Division ML f of)4.a Wif fls. - //w FROM: - Fred / rick C. Combs, Acting Director' // '
Division of Industrial and Medical Nuclear Safety, NMSS
SUBJECT:
N. RC INTERPRETATION OF ABNORMAL OCCURRENCE CRITERION "lV. For Medical Licensees" In response to " Staff Requirements: SECY-98-042 - Amendment to SECY 97-288, ' Report to Congress on Abnormal Occurrences for Fiscal Year 1997,'" dated April 20,1998, we are conveying NRC's interpretation of Abnormal Occurrence (AO) criterion "lV. For Medical Licensees" in Management Directive 8.1.
AO criterion "lV, For Medical Licensees" states "A medical misadministration that:
. (a) L Results in a dose that is (1) equal to or greater than 1 gray (Gy) (100 rads) to' a major portion of the bone marrow, to the lens of the eye, or to the gonads, or (2) equal to or ,
greate"han 10 Gy (100^ rads) to any other organ; and j (b) Represents either'(1) a dose or dosage that is at leaht'50 percent greater than that
. prescribed in a written directive, or (2) a prescribed dose or dosage that (i) is the wrong radiopharmaceutical,* or (ii) is delivered by the wrong route of administration, or (iii) is 1 (f delivered to the wrong treatment site, or (iv) is delivered by the wrong treatment mode, or (v)is from a leaking source (s)." g
. *The wrong radiopharmaceutical as used in the AO criterion for medical misadministration f '
j$ : refers to.any radiopharmaceutical other than the one listed in the written directive or in the
@ clinical procedures manual.'
(: ,
CONTACT: Gary Purdy NMSS/IMNS
,(301) 415-7897- '
'9907010113 PDR BECY 990625 9e-o,4a .c ' . pan g fg g-r j y. gX/97'we
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2 A. R. Blough et al.
The staff in consultation with the Office of the General Counsel has determined that dose to a major portion of the bone marrow, to the lens of the eye, to the gonads, or to any other organ, as a result of a misadministration, is an absolute dose, regardless of the dose the site would have receivet!if the treatment was completed as prescribed in the written directive. For example, if the lens of the eye would have received 20 rad as a result of a properly performed teletherapy treatment, but instead received a dose of 100 rad as the result of a misadministration, the AO criteria in IV. (a)G would be met. In this example, the misadministration would be an AO if any one of the criteria in IV. (b) were also met.
l DISTRIBUTION: IMNS-7030 NRC Central File ' . . RECORD NOTE - COORDINATED WITH:
IMNS r/f TMartin, AEOD CJones NMSS r/f HKaragiannis, AEOD CJones, NMSS PDR: YES X NO
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DOCUMENT NAME: c:vmns7030 gwp To receive a copy of this document, indicate in M box:
"C"= Copy w/o att/enct "E" = Co sy w/att/ encl *N" = No copy *See previous concurrence 4 [2 '// ,0 b, OFC OB OB , QB n OGC NAME GPurdy/II* SMoore* 7 rbs STreby*
v DATE 5/13/1998 5/13/1998 f 6/)f/98 6/23/1998 -
OFFICIAL RECORD COPY 1
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' A. R. Blough et al.
l- The staff in consultation with the Office of the General Counsel has determined that dose to a major portion of the bone marrow, to the lens of the eye, to the gonads, or to any other organ, j as a result of a misadministration, is an absolute dose, regardless of the dose the site would /
have received if the treatment was completed as prescribed in the written directive. For example, if the lens of the eye would have received 20 rad asrmed a result of a pr teletherapy treatment, but instead received a dose of 100 rad as the result of a misadministration, the AO criteria in IV (a)(1) would be met. In this example, the misadministration would be an AO if any one of the criteria in IV (b) were also m
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a DISTRIBUTION:IMNS-7030
- NRC Central File RECORD NOTE - COORDINATED WITH:
IMNS r/f ' TMartin, AEOD CJones
' NMSS r/f HKaragiannis, EOD CJones, NMSS
.PDR: YES X NO DOCUMENT NAME: ommns7030 gwp To receive a copy of this document, indicate in the box: AD4 -
h "C"= Copy w/o att/ enclE" = Coay w/att/ encl"N" = No copy *See previous concurrence '
OFC dB OB OB OG0k IMNS /
NAME GPurdy/il* SMoore* ~FCombs* STreh DQ/of DATE 5/13/1998 5/13/1998 5/13/1998 6/ % /1998 /1998 OFFICIAL RECORD COPY l-I
, ,4 2
A. R. Blough et al.
The staff in consultation with the Office of the General Counsel has determined that dose to a major portion of the bone marrow, to the lens of the eye, to the gonads, or to any other organ, as a result of a misadministration, is an absolute dose, regardless of the dose the site would have received if the treatment was completed as prescribed in the written directive. For example, if the lens of the eye would have received 20 rem as a result of a properly performed teletherapy treatment, but instead received a dose of 100 rem as the result of a misadministration, the AO criteria in IV (a)(1) would be met. in this example, the misadministration would be an AO if any one of the criteria in IV (b) were also met.
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DISTRIBUTION: IMNS-7030 NRC Central File RECORD NOTE - COORDINATED WITH:
IMNS r/f TMartin, AEOD CJones NMSS r/f HKaragiannis, AEOD ,
CJones, NMSS ' l PDR: YES X NO DOCUMENT NAME: c:simns7030 gwp To receive a copy of this document, indicate in the box:
"C"= Copy w/o att/ encl. *E" = Co ay w/att/enct"N" = No copy *See previous concurrence MY 8 4/f/
OFC OB . Mi i $41 OGC IMNS y J 4 vim wp NAME GPurdy/II SMoore ACFCombs STreby DCool DATE -5/13/1998 5/13 /1998 5/13 /1998 5/ /1998 1 5/ /1998 OFFICIAL RECORD COPY u____--- __ _ _ _ _ _ _ _ _ _ _ _ - - _ . _ _ - - - - - - _ _ _ _ _ _ . _ _ _ _ _ _ . _ _ _ _