ML19289A215
| ML19289A215 | |
| Person / Time | |
|---|---|
| Issue date: | 04/14/1980 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| References | |
| REF-SSINS-6830 IEC-80-6, NUDOCS 8002280647 | |
| Download: ML19289A215 (2) | |
Text
..... _ _
.c
.SSINS No.: 6830 Accession No.:
UNITED STATES 8002280647%
NUCLEAR REGULATORY C0tiMISSION d
0FFICE OF INSPECTION AND EhTORCErfENT WASHINGTON, D.C.
20555 April 14, 1980 IE Circular No. 80-06 CONTROL AND ACCOUNTABILITY SYSTEMS FOR ItiPLANT THERAPY SOURCES Several incidents have been reported to the Nuclear Regulatory Commission (NRC) during the past two years regarding inadequate control of sealed radiation therapy sources which contain NRC-licensed byproduct materials. These incidents were the result of poor licensee management and failure to comply with the NRC Regulations. All individuals in your institution involved in the use of such sealed sources, as well as the management, should review the contents of this Circular.
DESCRIPTION OF SEVERAL INCIDENTS REPORTED TO THE NRC:
1 (a) 20 ribbons containing 135 Ir-192 seeds were implanted in a patient.
The radiation therapist removed twelve ribbons in the patient's room but did not count the seeds.
The removed seeds were left in a iead container in the patient's room until two days later when the remaining seeds were rescued.
When the seeds from both removals were counted, it was determined that some seeds were missing.
Subsequent surveys have not found all of the missing seeds.
(b) 182 Ir-192 seeds were removed from a patient and placed in a lead container which was located on a hospital cart. A ten seed ribbon later became displaced from the container, fell to the floor and was swept up by a vacuum cleaner. One seed was ripped out of the ribbon by a rotating brush of the vacuum cleaner and became lodged in the mechanism. The remaining nine seeds were found intact in the ribbon outside of the hospital near where the contents of the vacuum bag are normally emptied.
The above licensees were in violation of 10 CFR 20.207(a) and (b) which require that licensed material stored in an unrestricted area be secured from unauthorized removal from the place of storage, and if not in storage, be under the constant surveillance and immediate control of the licensee.
2.
A patient had twelve Ir-192 seeds implanted but only eight removed at the desired time. The remaining four iridium seeds were noticed missing about three months later. Licensee follow-up revealed that these seeds were still in the patient.
This is in violation of 10 CFR Part 35.14 (vii) which requires that implant patients remain hospitalized until a source count and a radia-tion survey confirm that all implants have been removed.
%Qh 0 W
- h
IE Circular No. 80-06 April 14, 1980 Page 2 of 2 3.
An applicator containing two 79 mci Cs-137 sources was removed from a patient and returned to the storage room, but not immediately dismantled.
A routine inventory two weeks later revealed that one of the two sources was missing.
The hospital was unable to either locate the missing source or determine who had disassembled the applicator.
4.
One hospital reported that a 40 mci Cs-137 uterine implant was dislodged from a patient and only af ter an extensive search was it found in a laundry room floor drain trench.
NOTICE TO LICENSEES NRC recommends that the following actions be considered by each licencee authorized to use sealed sources in topical, interstitial or intracavitary treatment of cancer. These recommended actions may already be a part of your program and may be conditions of your license.
If you change any procedures which are conditions of your license, you must notify the Radioisotope licensing Branch of NRC so that your license may be amended.
Review the adequacy of your procedures for the use and control of sealed therapy sources. Such procedures should include:
a.
Written instructions covering all phases of use and control.
These instructions should be readily available to all individuals involved with the use of sealed therapy sources.
In addition all users should be trained in the implementation of these procedures, b.
Establishment and maintenance of a source inventory log book.
This should contain a running inventory of all sources, based on physical counting, as they are received from the supplier, removed from storage for use in patients, and placed back into storage. The inventory records should clearly indicate the total number of sources in storage at all
- times, c.
Verification, by physical counting, the number of sources used in a treatment before they cre implanted and immediately after their removal from a patient, d.
Written instructions for survey of patients by a qualified person using proper radiation detection instruments.
This radiation survey should be performed as soon as practicable after the source removal, but in any case before the patient is released from the hospital.
In addition, the patient's room, all linen, clothing and other materials should be surveyed prior to removal from the room and upon termination of treatment to determine if any sources may have become dislodged, Requirement for frequent management audit of source inventory records for e.
completeness and accuracy.
S No written response to this Circular is requried.
If you requi'le additional information regarding this matter, contact the Fuel Facility and Materials Safety Branch of the appropriate NRC Regional Office.
IE Circular No. 80-06 Enclosure April 14, 1980 RECENTLY ISSUED IE CIRCULARS Circular Subject Date of Issued to No.
Issue 80-06 Control and Accountability 4/14/80 Medical licensees in Systems for Implant Therapy Categories G and G1 Sources 80-07 Problems With HPCI Turbine 4/3/E0 All holders of a power Oil System reactor OL or CP 80-05 Emergency Diesel-Generator 4/1/80 All holders of a power Lubricating Oil Addition and reactor OL or CP Onsite Supply 80-04 Securing of Threaded Locking 3/14/80 All holders of a power Devices on Safety-Related reactor OL or CP Equipment 80-03 Protection from Toxic Gas 3/6/80 All holders of a Hazards power reactor OL 80-02 Nuclear Power Plant Staff 2/1/80 All holders of Reactor Work Hours OLs, including research and test reactors, and cps 80-01 Service Advice for GE 1/17/80 All licensees of Induction Disc Relays nuclear power reactor operating facilis:ies and holders of nuclear power reactor cps 79-25 Shock Arrestor Strut 12/20/79 All licensees and Assembly Interference holders of power reactor cps 79-24 Proper Installation and 11/26/79 All Holders of a Calibration of Core Spray Power Reactor OL or Pipe Break Detection CP Equiysent on BWRs.
79-23 Notor Starters and 11/26/79 All Power Reactor and Contactors Failed Operating Facilities to Operate and Epiders of Reacto'y cps 4