Information Notice No. 93-31: Training of Nurses Responsible for the Care of Patients with Brachytherapy Implants

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
                            WASHINGTON, D.C. 20555

                                April 13, 1993

                                   OF PATIENTS WITH BRACHYTHERAPY IMPLANTS


All U.S. Nuclear Regulatory Commission medical licensees.


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 


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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.  


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.

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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.  


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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

1.  List of Recently Issued NMSS Information Notices
2.  List of Recently Issued NRC Information Notices

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