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NRC in accordance with 10 CFR Section 35.42 (Superseded Text) or 10 CFR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
8807220034
. IN 88-53
July 28, 1988
Page 2 of 3
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,
. IN 88-53
July 28, 1988
Page 3 of 3
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
IN 88-53
July 28, 1988
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, March 09, 2021