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UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 April 13, 1993 Information Notice No. 93-31: TRAINING OF NURSES RESPONSIBLE FOR THE CARE OF PATIENTS WITH BRACHYTHERAPY IMPLANTS Addressees All U.S. Nuclear Regulatory Commission medical licensees. Purpose NRC is issuing this information notice to alert addressees to recent events resulting in unnecessary radiation exposure, and to emphasize the need for adequate training of nurses responsible for the care of patients, particularly those treated with brachytherapy implants. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar problems. However, information contained in this notice does not constitute a new requirement, and no specific action or written response is required. Description of Circumstances The following cases are recent events, reported to NRC, that have resulted in therapeutic misadministrations to patients, and unnecessary exposure of licensee personnel. Case 1: During a brachytherapy implant, radioactive seeds (a total of 25, each containing 3.5 millicuries of iridium-192) were spaced at 0.5-cm intervals and located in a ribbon that was inserted through the patient's nose into an endobronchial catheter positioned in the patient's bronchi. The Ir-192 ribbon became dislodged from the catheter during the night (11 p.m. to 7 a.m.) shift. A nurse observed the ribbon outside the patient's nose at 2 a.m. The nurse did not realize that the seeds were within the ribbon. She handled the ribbon with her bare hands and taped it to the patient's face, which contributed to the consequence of the misadministration and resulted in unnecessary radiation exposure of approximately 17.8 rem to the nurse's hands. Before the nurse taped the ribbon, it dangled in front of the patient's face and, for an unidentified interval, the patient repositioned the ribbon in her hair. The patient received an estimated dose of 1032 rad to the left side of the face. A root cause of this misadministration was a failure of the licensee to instruct the nurse concerning radiation safety precautions associated with the care of the patient who had received the brachytherapy implant. The nurse had attended training sessions on such implants, but had 9304080188. IN 93-31 April 13, 1993 Page 2 of 4 not been provided specific instructions nor assigned primary responsibility for care of an endobronchial implant patient. Case 2: During a brachytherapy implant procedure, two ribbons, each containing six Ir-192 seeds, with a total activity of 48.25 mCi, were implanted into two catheters inserted into the patient's common bile duct, through an abdominal incision. During the night (11 p.m. to 7 a.m.) shift, the patient's dressings on the wound were wet and loose. A licensed practical nurse (LPN), who responded to the patient, found the Ir-192 ribbons dislodged and lying loose on the patient's abdomen. The LPN, not realizing that the Ir-192 seeds were in the ribbon, changed the patient's dressing and bed, and coiled each Ir-192 ribbon around her hand and taped them to the patient's abdomen. The oncologist had left verbal orders with the day shift charge nurse "not to change the dressing" but these orders were not passed on to the LPN. The patient's abdominal skin received an unnecessary exposure over various areas ranging from 172 rad to 1032 rad. The skin exposure to the hand of the LPN was 7.6 rad. One root cause of the misadministration was failure of the licensee to provide radiation safety instruction to all personnel caring for a patient undergoing implant therapy. The LPN had not received sufficient instruction to be able to recognize the brachytherapy seeds and handle them appropriately if, and when, they became dislodged. Discussion Both of these misadministrations, and the related unnecessary exposure, were directly attributable to insufficient training of nursing staff responsible for the care of patients with brachytherapy implants. There are general and specific requirements, described in 10 CFR that address training of licensee employees, including nurses involved with treating patients undergoing brachytherapy procedures. 10 CFR 19.12 requires, in part, that individuals working in or frequenting any portion of a restricted area shall be instructed in the health protection problems associated with exposure to such radioactive materials or radiation, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed. This training would include aspects of radiation biology, radiation physics, risk estimates, and ways of maintaining doses As Low As is Reasonably Achievable (ALARA). Regulatory Guide 8.29 describes the instruction that should be provided to the worker, concerning biological risks from occupational radiation exposure. This instruction includes both high dose effects (e.g., deterministic or non- stochastic effects) and low dose effects (e.g., carcinogenesis, teratogenesis, and genetic effects) of radiation. The intent of providing this information, including a comparison of radiation risk to other types of health risks, is that workers will develop an understanding of the risks involved and appropriate responses rather than excessive fear or lack of concern. 10 CFR 35.410(a) requires, in part, that the licensee provide radiation safety instruction to all personnel caring for patients undergoing implant therapy. This instruction must include the size and appearance of the brachytherapy. IN 93-31 April 13, 1993 Page 3 of 4 sources; procedures for patient and visitor control; and safe handling and shielding instructions in case of a dislodged source. The description of the brachytherapy source would include the appearance of the source during the implant (e.g., the difference between an isolated radioactive seed and a seed inserted into a ribbon for treatment). The instruction should include the various types of implants used by the licensee. In the event of a dislodged source, the source must be shielded so that neither the patient nor any other persons receive unnecessary exposure. Appropriate training should include practice drills to demonstrate handling of dummy (nonradioactive) sources and appropriate use of safety equipment (e.g., tongs and shielded containers). 10 CFR 35.410(a)(5) requires that the radiation safety instruction must include procedures for notification of the Radiation Safety Officer (RSO) if the patient dies or has a medical emergency. It is not the intent of this regulation that this notification be made before, or in lieu of, notification of the patient's physician, to allow the medical emergency to be handled. Exhibit 20 of Regulatory Guide 10.8, Revision 2, provides a sample form for nursing instructions for patients treated with temporary implant sources, which includes individuals to contact in the event of an emergency. 10 CFR 35.25(a)(1) requires that a licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user shall instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct material and in the licensee's written quality management program (QMP). Furthermore, 10 CFR 35.25(a)(2) requires that a licensee shall require the supervised individual, in part, to follow the instructions of supervising authorized user, and follow the written radiation safety and quality management procedures. It is essential that nursing personnel are provided adequate radiation safety training, as frequently they are attending the patient in the absence of the authorized user or the RSO. One of the specific objectives of the QMP is to ensure that each administration is in accordance with the written directive. Therefore, any nurse attending brachytherapy patients must be instructed in the licensee's QMP and be familiar with the written directive. If an authorized user has any specific instructions regarding care of the patient that pertain to radiation safety, the licensee has the responsibility to ensure that the supervised individual receives and follows these instructions. The instruction should also include the necessary procedures to follow in the event of either a medical emergency or radiological emergency. Licensees are reminded that 10 CFR 35.21(a) requires that an RSO be appointed to be responsible for implementing the radiation safety program. Furthermore, the licensee, through the RSO, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program. This includes, as specified in 10 CFR 35.21(b)(2)(x), that the RSO shall, in part, implement written policy and procedures for training personnel who work in or frequent areas where byproduct material is used or stored. . IN 93-31 April 13, 1993 Page 4 of 4 This information notice requires no specific action or written response. If you have any questions about the information in this notice, please contact the technical contact listed below, or the appropriate NRC regional office. ORIGINAL SIGNED BY Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Technical contact: Patricia K. Holahan, Ph.D., NMSS (301) 504-2694 Attachments: 1. List of Recently Issued NMSS Information Notices 2. List of Recently Issued NRC Information Notices .
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