IE Circular No. 80-06, Control and Accountability Systems for Implant Therapy Sources

                                                            SSINS No.:  6830
                                                            Accession No.: 
                                                            8002280647

                                UNITED STATES
                        NUCLEAR REGULATORY COMMISSION
                    OFFICE OF INSPECTION AND ENFORCEMENT
                           WASHINGTON, D.C.  20555

                               April 14, 1980

                                                   IE Circular No. 80-06 

CONTROL AND ACCOUNTABILITY SYSTEMS FOR IMPLANT 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 lead 
       container in the patient's room until two days later when the 
       remaining seeds were removed.  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 
       radiation survey confirm that all implants have been removed. 
.

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 after 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 licensee 
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 are 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. 

e.     Requirement for frequent management audit of source inventory records
       for completeness and accuracy. 

No written response to this Circular is required.  If you require additional
information regarding this matter, contact the Fuel Facility and Materials 
Safety Branch of the appropriate NRC Regional Office.