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

May 13, 1998

NRC INFORMATION NOTICE 98-18: RECENT CONTAMINATION INCIDENCES RESULTING FROM FAILURE TO PERFORM ADEQUATE SURVEYS

Addressees:

Part 35 Medical Licensees

Purpose:

NRC is issuing this information notice to alert addressees to recent contamination incidents resulting from inadequate surveys. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid problems. However, suggestions contained in this information notice are not new NRC requirements; therefore, no specific action nor written response is required.

Description of Circumstances:

During the past months, there have been two instances of radiopharmacies receiving contaminated packages from client facilities. The contamination in these cases was limited to the exterior of the package. In both cases, the packages were initially surveyed before leaving the originating facility and no contamination was found. However, a spill at each client's facility contaminated the packages resulting in removable contamination in excess of DOT's limit of 2200 dpm/100 cm2 (132,000 Bq/100 cm2). The packages were not resurveyed and were released with contamination. The two cases described below involve the contamination of packages with technetium-99m (Tc-99m). An explanation of the root causes of these incidents is provided.

Case 1: A delivery driver from a radiopharmacy picked up a transport box from a client radiopharmacy to return to the licensee's facility. The package was surveyed upon receipt at its destination and found to have removable contamination of 1,400,000 dpm (84 MBq) on its exterior. The radioactive contamination was determined to be Tc-99m. The delivery driver, delivery truck, and some areas in the licensee's facility were determined to be contaminated. Discussions among the NRC, the client radiopharmacy, and the licensee determined that a syringe containing Tc-99m had been dropped near the package, causing the contamination. Apparent root causes for the contamination were:1) failure of the licensee to identify the dropped syringe as a spill of radioactive material; and 2) failure of the licensee to perform a radiation area survey around the dropped syringe to identify the contamination on the cases.
Case 2: Two packages received at a licensee's facility from a client hospital were determined to have removable contamination in the amounts of 305,000 dpm/100 cm2 (18.3 MBq/100 cm2) and 2290 dpm/100 cm2 (137,400 Bq/100 cm2) respectively. No contamination was detected on the delivery driver, delivery vehicle, nor the radiopharmacy's facility. A review of this incident revealed that a minor spill at the client hospital, near the packages, was the likely cause of the contamination. The review also revealed that, upon decontamination of the floor, the technician surveyed the area and attributed the residual increase in radiation levels to the presence of a molybdenum-99/Tc-99m generator in the area, rather than relating it to the contaminated package. The technician did not conduct further, sufficiently sensitive, surveys of the empty packages, to determine whether the increase in radiation levels was caused by the generator or by another source. The licensee; therefore, failed to conduct a survey of the areas around the spill, as required by its spill procedures. This is a violation of license commitments. The root causes of the violation were:1) failure of the technician to follow procedures to conduct an adequate survey of the areas around the spill; and 2) failure of the technician to question the results of the survey and to pursue the cause of the detected increase in radiation.

Discussion:

The cases described above are two examples of the release of contaminated packages to nuclear pharmacies because of failures to conduct adequate and timely surveys as required by 10 CFR 20.1501, 10 CFR 30.53 and 10 CFR 35.70. In addition, as required by 10 CFR 35.21, the Radiation Safety Officer is responsible for the investigation of spills and the implementation of corrective actions, as necessary. 10 CFR 35.21 also requires the licensee to establish and implement procedures for training personnel who work in or frequent areas where byproduct material is used or stored, including training in procedures for performing surveys.

When a spill occurs, it is important that the licensee respond properly to the event and take adequate measures to prevent the spread of the contamination. A survey of the area after the cleanup helps to ensure that the contamination is removed and that the possibility of unintended release of radioactive material is minimized. Proper health physics procedures dictate that unexpected survey results be assumed correct until further investigation proves otherwise.

Each licensee is responsible for protecting public health and safety by ensuring that potential hazards are promptly identified, corrected, and, if required, reported. In addition, licensees are required to satisfy all NRC requirements related to conducting adequate surveys. Accomplishing this responsibility requires persistent and appropriate management oversight of licensed activities.

This information notice requires no specific action nor written response. If you have any questions about the information in this notice, please contact the technical contact listed below, or the appropriate regional office.

Original /s/ by:

Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards

Technical contact: Torre Taylor, NMSS
(301) 415-7900
Internet: [email protected]


(NUDOCS Accession Number 9805070130)