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.
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