Information Notice No. 84-27: Recent Serious Violations of NRC Requirements by Medical Licensees
SSINS No.: 6835
IN 84-27
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF INSPECTION AND ENFORCEMENT
WASHINGTON, D.C. 20555
April 17, 1984
Information Notice No. 84-27: RECENT SERIOUS VIOLATIONS OF NRC
REQUIREMENTS BY MEDICAL LICENSEES
Addressees:
All byproduct materials licensees authorized to possess and use byproduct
materials in institutional medical programs.
Purpose:
To bring to the attention of medical licensees the large number of recent
cases involving serious violations of NRC license conditions, to point out
the common causes of these violations, and to describe their consequences.
Discussion:
From January 1 to December 1, 1983 there have been 26 cases in which the NRC
has taken escalated enforcement action against byproduct materials
licensees. Nineteen of these cases involved a civil penalty, six involved
Orders, to suspend the license or to show cause why the license should not
be revoked, and one involved both a suspension Order and a civil penalty.
These escalated enforcement actions were taken because various serious
violations of NRC license requirements occurred. These violations included
employees being overexposed to radiation, members of the public being
unnecessarily exposed to radiation, and public property being contaminated
with radioactive material. In addition, the financial consequences to the
affected licensees have been significant because of the loss of income from
the payment of civil penalties, the cost of decontaminating property, and
the suspension or revocation of the license.
An analysis of the causes of these escalated enforcement cases shows that
there were three common causes for the serious violations and their conse-
quences. These causes were:
(1) Failure to read and understand the conditions of the license.
(2) Failure to train employees in the conditions of the license including
the radiation safety procedures that are incorporated into the
license.
(3) Failure to control operations including failure of licensee employees
to follow approved radiation safety procedures.
.
IN 84-27
April 17, 1984
Page 2 of 2
Attached are summaries of three medical licensee cases. They illustrate the
causes and consequences of the serious violations that the NRC has found
during inspections of this class of byproduct materials licensees.
One of the principal causes of violations is the fact that some licensees
are not cognizant of all the conditions of their license. NRC has found
during inspections that some licensees have never read the license or have
little understanding of its conditions. Conditions and commitments in the
license form the basis for the issuance of the license, and are necessary to
protect the health and safety of the public. NRC, therefore, expects
licen-sees to abide with all the conditions and commitments of their
license.
Two other principal causes of violations are the failure to properly train
the workforce and the failure to control the radiation-safety aspects of the
licensee's operation. Licensee management is responsible for ensuring that
employees receive proper training, that the proper radiation monitoring
instrumentation and personnel dosimetry is available and used, and that
employees comply fully with all the provisions of the license and associated
radiation safety procedures.
The licensee's responsibility for control of its operations also extends to
consultants and contractors. In certain circumstances the NRC encourages
licensees to seek qualified assistance when the licensee does not possess
the necessary experience, training, equipment, or personal dosimetry to
perform particular activities; e.g., to handle problems arising from an
accident ur unusual occurrence. However, the responsibility for the safety
of the operations and compliance with NRC requirements remains with the
licensee.
Licensees should review the conditions of their license to ensure that they
understand their responsibilities under the license. This should include an
examination of the details of their radiation safety program to verify that
the program complies with all requirements. As a result, licensees can avoid
the serious consequences to their employees and the public and the
significant financial costs that can result from failure to follow NRC
requirements.
No response to this information notice is required. If you have any
questions regarding this matter, please contact the Administrator of the
appropriate Regional Office or this office.
J. Nelson Grace, Director
Division of Quality Assurance,
Safeguards, and Inspection Programs
Office of Inspection and Enforcement
Technical Contacts: J. R. Metzger, IE (301) 492-4947
E. D. Flack, IE (301) 492-9823
Attachments:
1. Selected Cases Involving Serious
Violations of NRC Requirements
2. List of Recently Issued IE Information Notices
.
Attachment 1
IN 84-27
April 17, 1984
Page 1 of 3
CASE A
Twelve violations were found at a hospital including five that were similar
to violations that had been found during the previous inspection. The most
significant violations are listed below.
Violations
1. Therapeutic sealed sources were used on patients over a three-year
period without authorization.
2. Unauthorized physicians were using radioactive materials.
3. Patients were not surveyed after sources were implanted.
4. Nurses assigned to brachytherapy patients were not issued film badges
or thermoluminescent dosimeters.
Causes
1. Licensee management and employees did not read and understand the
conditions of the license.
2. Licensee management and employees did not adequately control the
licensed activities of the hospital.
Consequence
1. Potential overexposure to patients and the hospital staff because of
failure to observe necessary safety procedures.
Enforcement
NRC imposed a civil penalty of $2,500 which the licensee paid.
.
Attachment 1
IN 84-27
April 17, 1984
Page 2 of 3
CASE B
Twelve violations were found at a hospital including two that were similar
to violations that had been found during a previous inspection. The most
significant violations are listed below:
Violations
1. The licensee failed to perform surveys for releases of Xenon-133 to
unrestricted areas.
2. Trash containing 70 microcuries of iodine-125 was released to a
sanitary landfill.
3. The licensee failed to report a diagnostic misadministration to the
NRC.
4. The licensee failed to leak test brachytherapy sources at six month
intervals.
5. Some workers failed to wear disposable gloves while handling
radiopharmaceuticals.
6. A student did not wear TLD finger rings while preparing
radiopharmaceuticals.
7. An individual admitted pipetting by mouth radiopharmaceuticals
containing phosphorous-32.
Causes
1. Licensee management and employees did not adequately control licensed
activities at the hospital.
2. Workers were not adequately trained in the conditions of the license.
Consequence
1. Potential for unnecessary exposure and contamination spread to
hospital workers and members of the general public.
Enforcement
NRC imposed a civil penalty of $2,500 which the licensee paid.
.
Attachment 1
IN 84-27
April 17, 1984
Page 3 of 3
CASE C
Seven violations were found at a hospital during a routine inspection. The
most significant violations are listed below.
Violations
1. For over a month, two 50 millicurie cesium-137 brachytherapy sources
were left in unlocked shields on a transport cart. The unlocked
shields containing at least one of the sources were left unsecured in
patients' rooms for three days.
2. Cesium-137 sources that had,been removed from a patient were left in
unlocked shields on an unattended cart in an unlocked patient's room.
No one had been assigned responsibility for the sources.
Causes
1. Management and employees of the hospital did not adequately control
the licensed material and follow required procedures.
Consequence
1. A 50 millicurie Cesium-137 source was lost or stolen resulting in
potential unnecessary radiation exposures to patients, hospital
personnel, and members of the public.
Enforcement
NRC imposed a civil penalty of $2,000 which the licensee paid.
Page Last Reviewed/Updated Tuesday, March 09, 2021
Page Last Reviewed/Updated Tuesday, March 09, 2021