Information Notice No. 85-61, Supplement 1: Misadministrations to Thyroid Scans

                                                             SSINS No: 6835 
                                                               IN 85-61 
                                                           Supplement No. 1 

                                UNITED STATES
                        NUCLEAR REGULATORY COMMISSION
                    OFFICE OF INSPECTION AND ENFORCEMENT
                           WASHINGTON, D.C. 20555

                               April 15, 1987 

Information Notice No. 85-61, SUPPLEMENT 1:    MISADMINISTRATIONS TO 
                                                  PATIENTS UNDERGOING 
                                                  THYROID SCANS 

Addressees: 

All licensees authorized to use byproduct material for human applications. 

This notice supplements Information Notice No. 85-61 (attached). It is 
expected that licensees will review this supplemental information for 
applicability to their activities and consider actions, if appropriate, to 
preclude further iodine-131 misadministrations. However, suggestions 
contained in this information notice do not constitute NRC requirements; 
therefore, no specific actions or written response is required. 

Description of Circumstances: 

Since the original notice was issued on July 22, 1985, the NRC has reviewed 
14 additional iodine-131 misadministrations. The probable causes of these 
misadministrations are as follows: 

o    The cause of 8 of the 14 misadministrations can be ascribed to the 
     referring physician's order being misinterpreted or to a 
     miscommunication to the technologists. 

o    The cause of three other misadministrations can be ascribed to the 
     technologists not being sufficiently familiar with the iodine-131 
     dosage requirements for thyroid scan procedures that involve scanning 
     the chest area to ensure that the proper dosage was used. 

o    The cause of the remaining three misadministrations can be ascribed to 
     miscellaneous factors: a patient's identity was not verified before 
     administering the iodine-131 dosage; the technologist selected the 
     wrong iodine-131 capsule from the isotope laboratory and did not assay 
     it to ensure proper dosage before administering it to the patient; and 
     the nuclear medicine physician or radiologist was not aware that part 
     of the patient's thyroid was intact before prescribing the amount of 
     iodine-131 for administration to the patient for a whole-body 
     iodine-131 scan. 



8704090053 
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                                                 IN 85-61 Supplement No. 1 
                                                 April 15, 1987 
                                                 Page 2 of 3 

Discussion: 

Licensees that have experienced such misadministrations have found that the 
following corrective actions have been effective tn preventing iodine-131 
misadministrations. 

o    Provide periodic refresher training for nuclear medicine personnel 
     involved in the performance of thyroid studies that emphasizes the 
     effects on patients resulting from misadministrations involving 
     iodine-131. Maintain records of such training. 

o    For licensees conducting infrequent or nonroutine nuclear medicine 
     procedures involving the administration of iodine-131, ensure that the 
     authorized user, and any physicians under the supervision of the 
     authorized user, as well as the technologists involved are sufficiently
     familiar with these procedures so that they will be properly conducted.

o    Establish a manual that contains the groper procedures for each of the 
     nuclear medicine studies (i.e., thyroid uptake, thyroid uptake and 
     scan, thyroid neck and chest, thyroid whole-body scan, etc.). 

o    Ensure that all thyroid studies referred to the nuclear medicine 
     department involving the administration of iodine-131 will be in 
     written form and the authorized user, or any physicians under the 
     supervision of the authorized user, will prescribe an appropriate 
     thyroid study for the particular patient conditions. For example, 
     interview the patient, obtain additional information from the referring 
     physician if needed, examine the patient, and sign the iodine-131 
     thyroid study prescription. 

o    Instruct all personnel involved in the performance of iodine-131 
     studies to request clarification from the prescribing physician if any 
     element of a prescription or procedure is unclear, ambiguous, or 
     apparently erroneous. 

o    Before each administration to a patient (adult or child), always 
     calculate the required dosage for the prescribe procedure, and then 
     ensure the correct dosage is prepared by calibrating that dose in the 
     dose calibrator. 

o    Ensure compliance with 10 CFR 35.53, measurement of radiopharmaceutical
     dosages, 35.60, syringe shields and labels, and 35.61, vial shields and
     labels prior to administration of iodine-131, and maintain records of 
     dosage disposition. 
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                                                 IN 85-61 Supplement No. 1 
                                                 April 15, 1987           
                                                 Page 3 of 3              

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


                                   Edward L. Jordan Director 
                                   Division of Emergency Preparedness 
                                     and Engineering Response 
                                   Office of Inspection and Enforcement 

Technical Contact:  H. Karagiannis, IE
                    (301) 427-9030

Attachments:
1.   Information Notice No. 85-61
2.   List of Recently Issued IE Information Notices