ML20210H623

Followup Rept on Voluntary Reporting by Agreement States on Specific Events.Results of Review of Addl Info Modify Staff Conclusion Presented in 970618 Memo

ML20210H623
Person / Time
Issue date:	07/24/1997
From:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Diaz N, Dicus G, Shirley Ann Jackson, Mcgaffigan E, The Chairman NRC COMMISSION (OCM)
References
NUDOCS 9708140130
Download: ML20210H623 (8)

Text

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UNITED STATES g*

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NUCLEAR REGULATORY COMMIS810N e

WASHINGTON, D.C. 206&H001 July 24. 1997 MEMORANDUM TO:

Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffi an FROM:

L. Joseph Callan Executive Directo f perations

SUBJECT:

FOLLOWUP REPORT ON VOLUNTARY REPORTING BY THE AGREEMENT STATES My June 18,1997 memorandum to the Commission on this subject noted that additional information on specific events was requested from some Agreement States. In addition, my memorandum concluded that the Ag eement States are reporting "stgnificant" events to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less after notification by their licensee. Agreement Etate regulators requiru the reporting of "significant" events by Agreement State licensees through regulations that are compatible to NRC's 10 CFR regulations. The staff reviewed additional event informetion received subsequent to the June 18,1997 memorandum, and found three instances where Agreement States have not properly reported "significant" events. These are discussed below. The results of the review of this additional hformation modify the staff conclusion presented in the June 18,1997 memorandum.

A staff revl<tw of a one year summary of routine event information, provided by the New York Department of Labor, identified a possible overexposure involving a source that became detached from the source rod in a Troxler moisture density gauge which occurred on April 20,1997. From the limited information provided, it appeals that an 8 millicurie Eo$

Cs 137 source capsule disconnt,cted from the rod, and one individual picked it up and placed it in a truck. The second Individual, identified as the radiation safety officer (RS0),

I picked up the source and held it against the rod and forced it to retract into the shield.

The licensee reported the equipment problem to Troxler, the gauge ma f

a North Carolina licensee, notified the State. The State of North Carolina notified New o

York, and the Region 11 Reglonal State Agreements Officer. The staff of Region ll notified g

Region 1. Region I staff contacted the State of New York for further information, and were, \\

u informed by the program director for the New York Departinent of Labor that it is the d

Department's policy to provide a report to NRC at the end of their investigation and e

- resolution of any enforcement action. The State indicated that they were investigating the event and had requested the licensee to retain a radiation therapy medical physicist to assess the dose to the hands of the user and RSO within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, and to express mall the Individuals' badges to the vendor for a reading. The State also amended the license to e

authorize storage only pending the outcome of an enforcement conference. Agreement D

State regulations compatible with 620.2202 should require the reporting within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> d

by the licensee of any event that may have caused, or threatens to cause "a shallow. dose equivalent to the skin or extremities exceeding 50 rems (0.5Sv)in a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />."

b Under current guidance, the Agreement State should voluntarily report "significant" events CD h

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The Commissioners 2-to the NRC within the next working day of being notified of the occurrence of the event by their licensee.

A review by the staff of routine event information in the Nuclear Materials Events Database (NMED) system provided by the S'ea of California identified a misadministration that occurred on February 28,1990, involving iodine 131 that was routinely reported to NRC on January 9,1997. Tha report Indicates that a patient undergoing evaluation for a superior mediastinal mass mistakenly received an administration for evaluation of metastatic disease. The patient may have received an unintended dose to the thyroid of 9100 centigray (9100 rad) which may induce a hypothyroid state requiring exogenous thyroid hormone. The event has been identified by NRC staff as a possible abnormal occurrence. The State of California has not adopted the revised Part 35 rule covering Reporting and Quality Management.

A review by staff of routine event information in the NMED system provided by the State of South Carolina identified a misadministration that occurred on December 11,1996, involving lodine 131 that was routinely reported to NRC on January 14,1997, that could be a possible abnormal occurrence. The initial report indicated that a patient who had previously received treatment for Graves' disease received an unintended dose of 370 megabecquerel (Mbq) (10.0 millicuries) of I 131 instead of the prescribed 74 MBq (2 mCl),

and that the thyroid received only 1.9 centigray (1.9 rad). A followup consultant's report stated that based on a 03% uptake measurement for the patient, the dose to the thyroid was computed to be 40,400 rad, and the dose to other major organs was estimated at 25 rad to the bladder, 5.2 rad to the red marrow, and a total body dose of 15 rad.

At the staff's request, the State of California has provided an abnormal occurrence report and South Carolina has agreed to prepare a proposed abnormal occurrence report.

in accordance with compatible regulations, and guidance contained in the drau 1:ven.i Reporting Handbook," the three events discussed above thould have been reported to the NRC Operations Center by the Agreement State within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of notification by the Agreement State licensee. Although three events represents a small percentage of the event information provided by the Agreement States, it nevertheless changes the unquallfled statement that we are receiving information on "significant" events in accordance with compatible regulations, and within the time frame identified for reporting "significant* events in the revised procedures contained in the " Event Reporting Handbook."

In consideration of the above information, the staff is modifying the conclusion to indicate that it appears most of the Agreement States are providing information on "significant" events. However, staff is now aware that some States do not voluntarily provide the information on a timely basis and some States do not accurately differentiate between routine and "significant" events in their reporting to NRC. Staff again notes that reporting of event information to NRC will be required for purposes of compatibility by the final Adequacy and Compatibility Policy Statement which has been approved by the

The Commissioners 3-i Commission subject to resolution of comments in the Staff Requirements Memorandum dated June 30,1997. Thus, staff continues to believe event reporting to NRC by Agreement States will continue to improve as the now policy is implemented, cc:

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[):LT" 3 PD'f Event Renorting 11andbook EVENT REPORT COVER PAGE AGREEMENT STATE EVENT REPORT NO.

SC - 97

- 001 (Followup Report)

DATE:

July 15,1997 TO:

Deputy Director Office of State Programs

SUBJECT:

Followup Report on Medical Misadministration at Tuomey Regional Medical Center, Sumter, SC, on December 11,1996, involving 1-131 STATE:

South Carolina Signature and

Title:

Jim Peterson Deot. Of Health and Environmental Control Columbia. SC yygs903 bPR l

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Confidentiality Notice This transmission is intended only 1or the use of the individual or entity to wtiich it is addressed and moy contoln information which is privileged and confidential, if the reader of this message is not the intended reciplent, you are hereby notified that any disclosure. distribution, or copying of this information is strictly prohibited. If you received this transmission in error, please notify the sender immediately by colling the above telephone number.

DHEC 0504 (7/04)

JLL.15.1F '1 CM1% FR ?[ J*E$JPlMTf4 T,H [EQ}i??,*7, ~{l3;5 TO 0190MM22'* P.FS)b5 4

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MEMORANDUM kdicn\\

>lvision of Radiologic Sciences

. Deuslas htaynant, htD, Direewt TO:

Susan Starker

,2,ru cmoim.ross

-w moins:c2s Roben L, Dixon, Ph.D.((/

O FROW Fotet 1,. h Ph.D.

wea.mm DATE:

July 15,1997 RE:

Dose calculation for Graves patient,Nwho received 10.5 mci ofI-131 instead of the prescribed 2.0 mC ofI.131 on 12/11/96.

Based on your 63% uptake measurement for this patient, the dose to the thyroid is computed to be 40,400 rad compared to the 7700 rad you would have obtained with 2 mci, The dose to other major organs is estimated to be:

Bladder: 25 rad Total body: 15 rad Red marrow: 5.2 rad I have attached my reference data.

RLD:cre ec: Melinda Bradshaw, SCDHEC

WAKE FOREST The Bowman Gray School of Medicine M

Mvdical Cmter Bobievard a Wmston Salern,NC er157106S

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I 48 Radiation Dosimetry for the Adult Female and r

Fetus from Iodine-131 Administration in,

Hyperthyroidism M.G. Stabin, EE. Watson,' C.S. Marcus, and R.D. Sajk 1

MedicalSeternen Dietston. Oak Ridge Anociated Uniw1tries. Ook Audge. Tennente andNucleta Med Clinic, Harbor UCU Medical CeNer. Les Angele.t. Calffemic i

1 Wing uptake sad ntention data from patienu treated Through a stuey of the ioolne kinettes of 127 patiems, we at the Harbor UCLA Medical Center, we have de

- have developed radlet:en oose estimates to major organs and simple tuodel that may be used to est me fetus for petlents wm varying degrees of hyperthytoldism.

We observed a nogetive correlation between martmum tny, dose to the hyperthyroid patient from adrednis rold uptake and bio!cg!c haN tirne oflodkie et the thyroid tod iodine 131 ("'!). We segregated the patients into j

used tNs correlation m prothct the biologie haMme et fined according to maximum thyroid uptake which were dj.-

values cf maximum ttiyrood uptake. Dose estimates to the Mded further accortling to ses and,in the case of females, Wodoor. genods, ma row, thyroid. uterus, and whole body accordiDg to age. Biologi; kinetics were studied as a func.

were estvneted for mammum myroic uptaxes from 20% to tjon of maximum thyroid uptake. Radiation dose esti-100%. Bledder dose vaned from D.6 to 1,0 mGy/Mf14 and mates were derived for the inajor organs f4 the bc 'y. The 60se *.o to uterus varied from 0.036 to 0.00 mGy/MSc radiadon dose to she fetus wts of special concast, as a unoer dNfererft model assumptions. 005e estimates to the majority of hyperthyroid pe'jents are female and may b few and total thyroic wers apprommetec at att stA0es or of childbearing age. In radiciodine therapy studies pregnancy. Avrage fetal dose *es a maalmum borwoon 0 and 2 me of pregnaecy, Wm the maximum ranging from amount of radiciodine administered tney be so hirh th j

0.048 mGy/MBq to 0.063 mGy/MSq. ocoo%ng on mo@ the dose to the fetus from the urinary bladder and other assurrptons. Some radleton risks for trradiation of the fetus organs may be appreciable. The done to the fetal thyroid, and the fetal thyroid are oiscussed-which may begin to conecatrate lodide as early as the tenth J Nuct paed ta01;32:004 813 week of gestation (7), may be eatremely high. as this tiny organ concentmtes iodide that is availabic from the moth.

_ er's bloodstrasm (#)

i METH00s

, iation dose catimates have been calculated for ca.

d thyroid individuals for sevwal isotopes of lodite by a Thyroid uptake and biologic half tist rnessurtments wt MIRD Committee Task Group (!). This document is verY made on m podents truird for hypenhyroidism at the Harboe-useful for predicting the radiation dose to the thyroid and UCt.A Mteical Center No disunc6en was tende between those other mdor organs from radiolodine administrations, wls orava'damase and those with hot nodules, but the maiority had Oreves' disease, Men uptakes and biolosic half times were However, the diferences in iodine metabolism in patients mutund with *l, eithoush some meuuremenMO40% >404

$0% >50060% >60b?C% >70%40% >80%90% and nece eo % 17. Ises rwston aonopsic %w. e. Isso "8

hr recew4 comee 90. Srm use,em scieases owner'. ook Aege females were sear %ated into two aroups (these of sat less than Aar.onetao uwesmes, out Siege. TwoMu r, a5 yr and those aged 45 yr or morc) to see whether or not a clear 808 The Joumalof Nuclear Mec.eine. Vol. 32

• No. 5 e May 1991

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• 07/15e97 10:57 0

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TABLE 2 RadleSon Dote Estimates for 88'lin the Hyperihyred p, j- - -

Pabe'Ir* es a Funct'on of Maximum TNyrede Uptake

{

,,,,,'"5 Estimewd rectenan oose (m3yp44)

[{

Orgen 20' 40' oo' 80' 500' 3:saw 1'

1.0 0.05 0 70 0.80 0 60 j., N 2'

O.94 0 79 CD 31 0.59 0 81

)

N Ovaries 1

0.032 0.030 Toh 0.027 0.020 4

l 2

0.047 0.045 0.04:

0.043 0.04J

• '8 '

Red mar'ow 1 0.062 0.10 o.19 0.15 0.14 1

2 0.078 0.12 @.1 0.16 0.16

}

Tesws 1

0.026 0.024 0 022 0 021 0.021 8

2 0.030 0.037 0 036 0.035 0.035 Thysved 1 410 780 0?

1240 1960 120c uc0 FME 2. Mage wtioM 6ose to the W st as aw y2 800 760 1

n,g,ecna cy for patents with mournu n thyro;d urteiros et 209.,

Laerg:

1 0.040 0.0d 4 0040 0.036 0 006 60*A. and 100% and a thyroes u0 tune hafface o' 2.9 nr.

0.063 0 0cs 0.0t3 0.012 00s0

]

results in a 10wer radiation dose to the fetus, as mort of 2

0. 7 O

O.

the iodine is held up in the thyroid and decays before reaching the urinary bladder. Radiation dose estimates fo e 8 the fetal thyroid have been estimated by Watact (5) and a 1 r. rnyroie upsete ha'f-rrme 2 e w; and 2 - thyn=c uptens ns.

Daasser et al. pf). Watson assumed a constant biologie erre 6.1 hr.

half-time in the infant's thyrold, while Elsasser e1 tL as.

~~ sumed that the biclogic half.timt increased with gesta.

tient) age. Watson's er,imates of fetal thyroid dc:e per total. body bic!cgic half times were used 84 input jato the Unit activity administered to the mother were; rnenth 3, dynamic bladder model Ul).

260 n1Gy/MBo; month 4,550 mCy/MBq; month 5,640 Table 3 hows the radiation doxs to the fetus for max-mOy/MDq: month 6,1200 mGy/MBq: month 7, 810 imum thyroid uptakes of 20%,6085, and 100% and for mGy/MBq; month 8. 620 mCy/MBq: month 9, 490 both thyroid uptake biologie half-times. These values art mOy/MBq. Elsasser et al, setirnated the fetal thyroid dose plottad as a function ofstage ofgestation in Figurn 2 and per unit activity attninistered to the tacther to be: month

3. The figures c!carly show the slight in:rease dunes ths 3,43 r,.Oy/MBq; month 4,220 mGy/MBq: month 5,3*/0 first month, as the smwth of the !ttus causes a higher ;nu)/MBq; month 6, 640 mGy/M34; motith 7. 620 fruction of the photon energy emitted from activity in the mOy/MBq; month B, 520 mOy/h!Sq; month 9, 430 bladder to be absorbed, and a steady decrease afkr this, as mGy/MBq. In both sets of eximates, the maximum thy.

the increme in fetal mm othets the increme in abertrd roid dose per unit activity adven to the mother is scon in friction.The fgures also show that a higher th>Toid uptake month 6. This is the time at which the retal thyroid TABLE 3 Redtatton Dose Estimates for the Fetus at AA StaCes of Pregnancy from Adminlettstion of *l to tre Mothwr EstWated radiation dose (mGy/MBOT 20%'

60%'

100 %'

Age (me!

TM = 2.9 hr TM = t.1 hr TM = 2.9 nr T(v) = 61 er T(U) = 2.9 rr TM.s 0.1 hr 1

0.065 0.o63 0 053 0.072 0 044 0.071 2

0.044 0.0$$

0.036 0.043 0.033 0.048 3

0.030 0.065 0.032 0.045 0.03o 0.0d 6 4

0.026 0.o42 0.024 0 036 0.023 0.o37 5

0 021 0.002 0.01 4 0.o29 0.017 0.o30 E

C 016 0 029 0.016 0 026 0 016 0.027 7

0,010 0.027 0.015 0.024 0.014 0.025 a

0.016 0.026 0 014 0.024 0.014 c.c25 9

0.01 4 0.024 0.013 0.022 0012 0.C23

• Absartied dose to the fetwo per unit actvity adrvtdered to t*to mater.

' Mesanurn tmyrod uptake (%).

___TM ns the assumed thyroic 28efoe.c be3 time for voteks.

810 Tna Joumar of Nuciaar Mexscre Vol 37 No. 5 usy1991

"* " ' ~ * * ' '

• • TOTAL. PAGE,04 **