United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 88-53: Licensee Violations of NRC Regulations, Which led to Medical Diagnostic Misadministrations

                                  UNITED STATES
                          NUCLEAR REGULATORY COMMISSION
                OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                            WASHINGTON, D.C.  20555 

                                  July 28, 1988


Information Notice No. 88-53:  LICENSEE VIOLATIONS OF NRC REGULATIONS, 
                                   WHICH LED TO MEDICAL DIAGNOSTIC 
                                   MISADMINISTRATIONS 

Addressees: 

All manufacturers and distributors of radiopharmaceuticals for human use, 
nuclear pharmacies, and medical licensees. 

Purpose: 

This notice is to inform NRC licensees of enforcement action NRC took against 
a nuclear pharmacy which mislabeled vials of radiopharmaceuticals on six sepa-
rate occasions, over a 16-month period.  The mislabeling of vials with wrong 
chemical form resulted in diagnostic misadministrations at client hospitals.  
It is expected that licensees will review this notice, distribute it to appro-
priate personnel (including nuclear medicine physicians, respon-sible radiation 
safety officers, nuclear medicine staffs, and nuclear pharmacy staffs) and 
consider actions, as appropriate, to ensure that meticulous attention is paid 
to correctly labeling vials, vial shields, syringes, and syringe shields, and 
correctly assaying doses to prevent violations of the Commission requirements.
This information notice does not constitute new NRC requirements, and no 
written response is necessary.  It does however, convey a modification in the 
severity classification of violations of NRC requirements which have led to 
diagnostic misadministrations. 

Description of Circumstances: 

In a recent inspection of a nuclear pharmacy licensee, NRC found that the 
licensee incorrectly labeled vials containing radiopharmaceuticals on six 
separate occasions over a 16-month period.  In turn, these mislabeled products 
were dispensed to patients at various hospitals and resulted in 14 diagnostic 
misadministrations.  The hospitals reported these misadministrations to the 
NRC in accordance with 10 CFR Section 35.42 (Superseded Text) or 10 CFR 
Section 35.33(c), effective April 1, 1987. 

In each case, the label placed on the vial of material provided the correct 
radionuclide and correct quantity (activity) of material, but the chemical 
form of the material was incorrect.  Once such an error had been made, the 







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recipient hospital had no mechanism to verify the chemical form of the radio-
pharmaceutical.  (The NRC license issued to the nuclear pharmacy required that 
certain checks be performed of the radioactive aspects of the radio-
pharmaceutical; i.e., the amount of radioactivity present.  These checks were 
correctly performed.)  Because different chemical forms are used to transport 
the radioactive material to different parts of the body, e.g., liver vs. brain 
vs. bone, etc., mislabeling can cause unnecessary radiation exposure to a part 
of the body other than that intended, as well as failure to produce the needed 
diagnostic information.

Nuclear pharmacies are required, as part of their license application, to 
submit labeling to the NRC.  The labels must specify the radiopharmaceutical 
name (i.e., isotope and chemical form) in order to prevent errors that could 
lead to a misadministration, as indicated in "Guide for the Preparation of 
Applications for Nuclear Pharmacy Licenses," Division 10, Task FC 410-4, 
August 1985 pp. 33-34.  When the license is approved and issued by the NRC 
staff, the application is incorporated by reference as a license condition.  
The license in this case required the use of a label that identified the 
radiopharmaceutical by radionuclide and chemical form. 

Hospitals are required to label syringes/syringe shields and vials/vial 
shields in accordance with 10 CFR Part 35.  

After review of the violation and consultation with the Commission, the NRC 
issued a Notice of Violation classifying the mislabeling errors as a Severity 
Level III violation.  Severity Level III violations can result in a civil 
penalty. 

Discussion: 

10 CFR Part 2, Appendix C, "General Statement of Policy and Procedure for NRC 
Enforcement Actions," (1988) (Enforcement Policy), Supplement VI provides that 
a violation involving the failure to report a diagnostic misadministration to 
the NRC constitutes an example of a Severity Level IV violation.  The factors 
that cause diagnostic misadministrations often do not constitute violations of
NRC requirements.  As a result, there have been very few enforcement actions 
in the past in which errors causing diagnostic misadministrations are cited as 
violations.  When such violations are cited, they generally have been cate-
gorized at Severity Level V, a level reserved for violations of minor safety 
significance. 

The NRC has reconsidered the past practice of classifying violations involving 
diagnostic misadministrations and believes that, consistent with the example 
for classification at Severity Level IV of violations, involving a failure to 
report medical diagnostic misadministrations, a violation of the NRC's 
requirements which result in a medical diagnostic misadministration should 
also be classified at Severity Level IV.  Additionally, a violation involving 
multiple errors of the same or similar root cause that results in several 
misadministrations over the inspection period (e.g., the inspection frequency 
for the license, i.e., two years for nuclear pharmacies and broad medical 
programs, 
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three years for specific medical licensees) or a recurrent violation from the 
previous inspection period that results in a misadministration, may be classi-
fied at a higher level to increase the licensee's sensitivity to this issue.  
Such sensitivity is especially important for labeling errors involving 
chemical forms, because these errors cannot be easily detected by the 
customer.  Therefore, violations involving multiple errors or recurrent 
violations contributing to diagnostic misadministrations may constitute a 
significant failure to control licensed material and could be categorized at 
Severity Level III.  Violations categorized at a Severity Level III may result 
in a civil penalty. 

The NRC is proceeding to modify the existing Enforcement Policy to reflect the
new categorization of violations in this area. 

No specific action or written response is required by this information notice.
If you have any questions about this matter, please contact the Regional 
Administrator of the appropriate NRC regional office or this office. 




                              Richard E. Cunningham, Director 
                              Division of Fuel Cycle, Medical Academic 
                                and Commercial Use Safety
                              Office of Nuclear Material Safety 
                                and Safeguards 

Technical Contact:  M. Lamastra, NMSS 
                    301-492-3416 

Attachment:  List of Recently Issued NRC Information Notices 

.                                                            Attachment
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                                                            Page 1 of 1

                             LIST OF RECENTLY ISSUED
                            NRC INFORMATION NOTICES 
_____________________________________________________________________________
Information                                  Date of 
Notice No._____Subject_______________________Issuance_______Issued to________

88-52          Failure of Intrauterine       7/27/88        Medical licensees.
               Tandem of Fletcher 
               Applicator Brachytherapy 
               Devices During Patient 
               Treatment 

88-46,         Licensee Report of            7/26/88        All holders of OLs
Supplement 1   Defective Refurbished                        or CPs for nuclear
               Circuit Breakers                             power reactors. 

88-51          Failures of Main Steam        7/21/88        All holders of OLs
               Isolation Valves                             or CPs for nuclear
                                                            power reactors. 

88-50          Effect of Circuit             7/18/88        All holders of OLs
               Breaker Capacitance                          or CPs for nuclear
               on Availability of                           power reactors. 
               Emergency Power 

88-49          Marking, Handling,            7/18/88        All holders of OLs
               Control, Storage and                         or CPs for nuclear
               Destruction of Safe-                         power reactors and
               guards Information                           all other licensed
                                                            activities 
                                                            involving a 
                                                            formula quantity 
                                                            of special nuclear
                                                            material. 

88-48          Licensee Report of            7/12/88        All holders of OLs
               Defective Refurbished                        or CPs for nuclear
               Valves                                       power reactors. 

88-47          Slower-Than-Expected          7/14/88        All holders of OLs
               Rod-Drop Times                               or CPs for PWRs. 

88-46          Licensee Report of            7/8/88         All holders of OLs
               Defective Refurbished                        or CPs for nuclear
               Circuit Breakers                             power reactors. 

88-45          Problems In Protective        7/7/88         All holders of OLs
               Relay and Circuit                            or CPs for nuclear
               Breaker Coordination                         power reactors. 
_____________________________________________________________________________
OL = Operating License
CP = Construction Permit 
Page Last Reviewed/Updated Tuesday, November 12, 2013