ML20237A547
| ML20237A547 | |
| Person / Time | |
|---|---|
| Issue date: | 07/30/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL, MINNESOTA, STATE OF, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF |
| Shared Package | |
| ML20237A549 | List: |
| References | |
| SP-98-040, SP-98-066, SP-98-40, SP-98-66, NUDOCS 9808140167 | |
| Download: ML20237A547 (9) | |
Text
,
- .e Q RE2 4 UNITED STATES t
s" g NUCLEAR REGULATORY COMMISSION
- WASHINGTON. D.C. 20555-4001 y ,o July 30, 1998 ALL AGREEMENT STATES l
MINNESOTA, OHlO, OKLAHOMA, PENNSYLVANIA
' TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-98-066)
Your attention is invited to the enclosed correspondence which contains:
INCIDENT AND EVENT INFORMATION........... XX ACKNOWLEDGMENT OF RECEIPT OF NMED REPORTS AND CLARIFICATION OF AO CRITERIA FOR A DOSE TO THE WRONG TREATMENT SITE OF A PATIENT MANAGEMENT INFORMATION.. .. . ...............
TRAINING COURSE INFORMATION................
TECHNICAL INFORMATION... ..................... ...
OTH ER I N FO 9 MATION............... .......... .......... {
Supplementary information: NMED Reports: During the Integrated Materials Performance i Evaluation Program (IMPEP) reviews, instances have been identified where event reports sent.
to the Idaho National Engineering and Environmental Laboratory (INEEL) by Agreement States )
were either not received or were not entered into the Nuclear Materials Events Database 1
' (NMED). In these instances, the INEEL staff did not have a record of receiving the event and the Agreement State had no record of sending the event report to INEEL. Currently, upon receipt of event reports from Agreement States by e-mail or on diskette, INEEL sends an e-mail message acknowledging the receipt of the report to the Agreement State. To ensure that an acknowledgment is on record, INEEL is modifying the procedure to include the following:
The INEEL will acknowledge by e-mail (if available, otherwise by regular mail) all submissions of event reports sent directly to INEEL. You should receive acknowledgment by e-mail within two working days or acknowledgment by regular mail within seven working days. If you do not receive acknowledgment of your submission, 1 you may contact the INEEL by e-mail (GDR@lNEL. GOV) or by regular mail at Idaho l National Engineering and Environmental Laboratory, Attention: Gary Roberts, i P.O. Box 1625, Idaho Falls, ID 83414. k
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~ a SP-98-066 M 30 m Clarification of AO Criteria: The Commission directed staff, in Staff Requirements Memorandum (SRM) SECY-97-288, dated February 6,1998, to provide clarification regarding event AO 97-2 (Enclosure 1) in the draft Report to Congress on Abnormal Occurrences for Fiscal Year 1997. Specifically, the Commission requested staff to clarify the reasoning for listing event AO 97-2 and explain how the lens of the left eye received a dose of 100 rads greater than it would have received under a successful treatment when the displacement caused the source to move away from, rather than towards the left eye. Additionally, the staff .
should provide clarification regarding the interpretation of the AO criterion IV(a)(1) for misadministration. That is, is the staff's interpretation of the criteria regarding the 100 rads delivered to the bone marrow, the lens of the eye, or to the gonads, a dose that is in addition to the dose these sites would have received in a successful treatment, or is this an absolute dose, regardless of the dose the site would have received in a successful treatment.
In consultation with the Office of the General Counsel, the staff provided the following clarification in SECY-98-042 dated April 20,1998:
A dose to a patient's wrong treatment site, as a result of a misadministration, is an absolute dose, regardless of the dose such site would have received if the treatment was completed as prescribed in the written directive. Therefore, since the AO criteria for misadministration are based on the definitions of misadministration, the 1 gray (Gy)
(100 rad) dose to the bone marrow, the lens of the eye, or to the gonads, as a result of a misadministration to a wrong treatment site, is an absolute dose.
The Commission, in Staff Requirements Memorandum (SRM) to SECY-98-042 (Enclosure 2),
directed staff to disseminate this interpretation of cruerion for misadministration to the Agreement States. 1 The " Handbook on Nuclear Material Event Reporting in the Agreement States," which was enclosed with SP-98-040, dated May 7,1998, contains a copy of the AO criteria. Please note ;
that the Handbook reflects the revised AO criteria which were published in the Federal Reaister on April 17,1997 (62 FR 18820) to incorporate minor changes and to revise Criterion lli covering Fuel Cycle Facilities.
If you have any questions regarding this correspondence, please contact me or the individuai named below.
POINT OF CONTACT: Patricia M. Larkins TELEPHONE: (301) 415-2309 FAX: (301) 415-3502 INTERNET: PML@NRC.pOV C lit - f n
Paul H. Lohaus, Deputy Director '
Office of State Programs j l
Enclosures:
l l As stated
- v SP 066 JUL 3 0 998 Clarification of AO Criteria: The Commission directed staff,in Staff Requirements Memorandum (SRM) SECY-97-288, dated February 6,1998, to provide clarification regarding event AO 97-2 (Enclosure 1) in the draft Report to Congress on Abnormal Occurrences for Fiscal Year 1997. Specifically, the Commission requested staff to clarify the reasoning for listing event AO 97-2 and explain how the lens of the left eye received a dose of 100 rads greater than it would have received under a successful treatment when the displacement caused the source to move away from, rather than towards the left eye. Additionally, the staff should provide clarification regarding the interpretation of the AO criterion IV(a)(1) for misadministration. That is, is the staff's interpretation of the criteria regarding the 100 rads delivered to the bone marrow, the lens of the eye, or to the gonads, a dose that is in addition to the dose these sites would have received in a successful treatment, or is this an absolute dose, regardless of the dose the site would have received in a successful treatment.
In consultation with the Office of the General Counsel, the staff provided the following clarification in SECY-98-042 dated April 20,1998:
A dose to a patient's wrong treatment site, as a result of a misadministration, is an absolute dose, regardless of the dose such site would have received if the treatment was completed as prescribed in the written directive. Therefore, since the AO criteria for misadministration are based on the definitions of misadministration, the 1 gray (Gy)
(100 rad) dose to the bone marrow, the lens of the eye, or to the gonads, as a result of a misadministration to a wrong treatment site, is an absolute dose.
The Commission, in Staff Requirements Memorandum (SRM) to SECY-98-042 (Enclosure 2),
directed staff to disseminate this interpretation of criterion for misadministration to the Agreement States.
The " Handbook on Nuclear Material Event Reporting in the Agreement States," which was I enclosed with SP-98-040, dated May 7,1998, contains a copy of the AO criteria. Please note I that the Handbook reflects the revised AO criteria which were published in the Federal Reaister on April 17,1997 (62 FR 18820) to incorporate minor changes and to revise Criterion lli covering Fuel Cycle Facilities, if you have any questions regarding this correspondence, please contact me or the individual named below.
POINT OF CONTACT: Patricia M. Larkins TELEPHONE: (301) 415-2309 FAX: (301) 415-3502 Siged By INTERNET: PML@NRC. GOV RD LBANGART Paul H. Lohaus Deputy Director O Office of State Programs
Enclosures:
As stated Distribution:
DlR RF (8S136; 8S164) DCD (SP03)
OS) Staff DCool, NMSS PDR (YES/) l FXCameron, OGC JPiccone, NMSS l HNewsome, OGC MKnapp, NMSS NCostanzi, RES SPettijohn, AEOD E-MAILED TO STATES: 7/31/98 CTrottier, RES FCongel, AEOD 1
All A/S File DOCUMENT NAME: G:\TJO\SP98066.wpd *See previous concurrence. ,
'o receive a con r of this document. Indicate in th i bor "C" = Cooy without attachment / enclosure *E' r coov with attachment / enclosure *N" = No copy
)
OFFICE OSb l OSP:DD l OSP:D / N ' [_ ;
( NAME TO'Brierdr%Ek:nb PHLohaus RLBangart/W l
DATE 06/23/98* 06/23/98* 07/b /98 i
~ ~:
SP by regular mail at Idaho National Engineering and Enviro mental Laboratory, Attention:
Gary Roberts, P.O. Box 1625, Idaho Falls, ID 83414.
Clarification of AO Criteria: The Commission directed staff, in Staff Requirements Memorandum (SRM) for SECY-98-042 dated April 20,1998 (efclosed), to provide clarification regarding the interpretation of the AO criterion IV(a)(1) for mis administrations and to disseminate this interpretation to the Agreement States.
The staff in consultation with the Office of the General Counsel has provided the following clarification: /
A dose to a patient's wrong treatmentltsite, as a resu/ is an of a misadministration, absolute dose, regardless of the dose such site wohld have received if the treatment was completed as prescribed in the written directivh. Therefore, since the AO criteria for misadministration are based on the definitions of[ misadministration, the 1 gray (Gy)
(100 rad) dose to the bone marrow, the lens of the eye, or to the gonads, as a result of a misadministration to a wrong treatment site, is arf absolute dose.
The " Handbook on Nuclear Material Event Reporting the Agreement inj/ which was States,"
enclosed with SP-98-040, dated May 7,1998, contains a copy of the AO criteria.' Please note that the Handbook reflects the revised AO criteria which were published in the Federal Reaister on April 17,1997 (62 FR 18820) to incorporate minor [ changes and to revise criterion Ill covering Fuel Cycle !!censees.
If you have any questions regarding this correspondence, please contact me or the individual named belew.
POINT OF CONTACT: Patricia M. Larkins TELEPHONE: (301)/415-2309 FAX: (301 415-3502 INTERNET: PM NRC. GOV Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated Distribution: [
DIR RF(8S13 ;8S16f)
OSP Staff
/Cool, NMSS[ DCD (SP03)
PDR (YES/)
FXCameron, OG JPiccone, NU}SS HNewsome, OGC MKnapp, NMSS NCostanzi, RES SPettijohn, EOD CTrottier, RES FCongel, A OD All A/S File DOCUMENT NAME: G:\TJO\SP98XAO. /
T 5' receive a copy of this document, indicate in the box: "C" ' attacnmenvenclosure "E' = Copy with attachment /enclosuro "N' = No copy f OFFICE OSP __, l OSP M// jl OSP:D l l l l NAME TO'Brien:nb W PHLoha$ N T RLBangart DATE 06/M/98 06 ff/Ei8 06/ /98 OSP FILE CODE: S P- A-4
97-2 Medical Brachytheraov Misadministration at Centre Community Hosoital. State Colleoe.
Pennsvivania The following information pertaining to this event is also being reported concurrently in the Federal Reaister. Appendix A (see Criterion IV, "For Medical Licensees") of this report states
- that a medical misadministration that results in a dose that is equal to or greater than 1 gray (100 rad) to the lens of the eye and is delivered to the wrong treatment site will be considered for reporting as an AO.
Date and Place - December 20,1996; Centre Community Hospital; State College, Pennsylvania Nature and Probable Consequences - A patient was prescribed a brachytherapy treatment using a high-dose remote afterloading device (HDR) to treat a surface skin cancer. During the l treatment, the mast used to hold the HDR treatment catheter containing the radioactive source .
in position at the tree.tment facial site, the right lateral edge of the nose where it conjuncts with the cheek, failed, and the catheter was inadvertently repositioned. As a result, the patients right
- lateral chin received an unprescribed radiation dose.
The NRC's medical consultant evaluated the misadministration and estimated that the patient's skin of the right chin received a radiation dose of approximately 2000 centigray (2000 rad) and 165 to 170 centigray (165 to 170 rad) to the lens of the left eye. The medical consultant indicated that the dose to the lens of the eye is about in the dose range for cataract formation, however, no other adverse effects to the patient are expected.
The licensee indicated that the patient had not been informed of the misadministration; however, the patient's referring physician and family had been informed.
Cause or Causes - The mask failed to hold the HDR treatment catheter in the correct position.
NRC determined that the use of the HDR device to treat surface skin cancer was not authorized by the facility's license. Therefore, NRC had not reviewed the licensee's procedures for securing the treatment catheter t a patient.
Actions Taken to Prevent Recurrence Licensee - The licensee provided corrective actions in a letter to NRC. The letter includes a commitment not to perform any skin surface treatments until a license amendment is granted.
NR_Q - NRC issued a Confirmatory Action Letter confirming that the licensee agreed to cease performance of any additional skin surface applications until a license amendment approving the procedure was obtained. ' NRC conducted an Enforcement Conference with the licensee and issued a Notice of Violation for unauthorized use of the HDR.
i This event is closed for purposes of this report.
l l
ENCLOSURE 1
.- . .s is April 20,1998 MEMORANDUM TO: L. Joseph Callan Executive Director for Operations FROM: John C. Hoyle /S/
SUBJECT:
Staff Requirements: SECY-98-042 - Amendment to SECY 97 -
288, " Report to Congress on Abnormal Occurrences for Fiscal Year 1997"
' The Commission did not object to the contents of the proposed revised Fiscal Year 1997 Abnormal Occurrence Report to Congress and the revised letters to Congress. The staff should therefore forward the revised letters to Congress for the Chairman's signature.
(EDO) (SECY Suspense: 5/8/98)
- . In light of the error in identification of an incident in the earlier version of the report and the possibility that it may have been due in part to a lack of common understanding by the staff of the interpretation of abnormal occurrence criterion IV(a)(1) for misadministration, the Commission requested that the staff's interpretation of criterion for misadministration, as l contained in SECY-98-042, be disseminated to the appropriate staff in Headquarters, the L Regions, and the Agreement States.
i
! .(EDO) ; . (SECY Suspense: 5/8/98) cc: Chairman Jackson -
- 1 Commissioner Dicus 4 i I; Commissioner Diazt
- . Commissioner McGaffigan l OGC CIO
'olG-Office Directors, Regions, ACRS, ACNW, ASLBP (by E-Mail)
-PDR DCS 3
SECY NOTE: This SRM and SECY 98-042 will be made publicly available after the FY 97 Abnormal Occurrence Report has been issued to the Congress.
ENCLOSURE 2
,Y C $ i 5 & 3 W i p';
! PLEASE FORWARD IMMEDIATELY l
U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS OFFICE OF STATE PROGRAMS FAX: (301) 415-3502
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NUMBER OF PAGES: 5 including this page DATE: JULY 30,1998
)
TO: RADIATION CONTROL PROGRAM DIRECTORS IN RHODE ISLAND, PENNSYLVANIA AND MINNESOTA l-FROM: PAUL H. LOHAUS, DEPUTY DIRECTOR OFFICE OF STATE PROGRAMS i
SUBJECT:
SP-98-066 ACKNOWLEDGMENT OF RECEIPT OF NMED REPORTS AND CLARIFICATION OF AO CRITERIA FOR A DOSE TO THE WRONG TREATMENT SITE OF A PATIENT i
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VERIFICATION - 301-415-3340 l
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