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.