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Information Notice No. 89-12: Dose Calibrator Quality Control
UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 February 9, 1989 Information Notice No. 89-12: DOSE CALIBRATOR QUALITY CONTROL Addressees: All NRC medical licensees. Purpose: This notice is provided to alert recipients to a frequent problem concerning dose calibrator quality control tests, identified by NRC inspectors during inspections of medical programs, and also to emphasize the importance of quality control procedures for equipment used to assay patient doses. It is expected that licensees will: review this information for applicability to their programs; distribute this notice to those responsible for radiation safety and medical quality assurance, including technologists; and consider actions to preclude similar situations from occurring at their facilities. However, the suggestions contained in this notice do not constitute any new NRC requirements, and no written response is required. Description of Circumstances: During recent NRC inspections of medical facilities, inspectors have found deficiencies and irregularities in the performance and recording of dose calibrator quality control tests. The most common deficiency is a failure to evaluate the recorded measurements against expected values, in order to validate proper dose calibrator operation within the tolerances specified in NRC regulations, licensee operating procedures, and license conditions. Technologists often base their dose calibrator acceptance criteria solely on the lack of any sudden or large changes in the recorded measurements, rather than using the approved, required NRC standards. NRC inspectors have documented several instances where measured readings have gradually deviated from expected values; yet, licensees have failed to detect, and therefore correct or repair, malfunctioning dose calibrators. In some instances, a dose calibrator was later determined to be functioning properly, but the test itself had been performed improperly. In all of these instances, prompt evaluation of recorded results would have assured proper performance of tests and validation of measured patient doses. 8902060122 . IN 89-12 February 9, 1989 Page 2 of 3 Other types of problems related to the use of dose calibrators have also been identified. In some cases, licensees have identified a malfunctioning dose calibrator, but then failed to take action to correct the problem. In one particular instance, the licensee's consultant made initial arrangements for a replacement dose calibrator after a linearity test demonstrated non-linearity, but the licensee did not act on the consultant's recommendation and waited one month before retesting the dose calibrator. In other cases, technologists failed to perform constancy checks when emergencies required the dose cali-brator to be used during periods such as weekends, when radiopharmaceuticals are not normally administered to patients. Of serious concern to the NRC is the finding, during several inspections, that false information was recorded for dose calibrator tests. In one case, a consultant requested a technologist to repeat the linearity test. Instead of repeating the test, the technologist created a record using the results of a linearity test performed 30 months before the recorded date. In another case, an NRC inspection at a hospital revealed records indicating that a cobalt-57 check source (half life of 271 days) had not shown any decay in two months, resulting in a 15% decrepancy. Discussion: All medical licensees are reminded of the importance of making accurate quality control checks of dose calibrators used to assay patient dosages. NRC believes that the performance and evaluation of these dose calibrator checks are necessary to ensure that the dosage administered is the same as the dosage that was prescribed for the patient. These checks are es- sential steps for assuring safety and quality in the medical use of byproduct material. Therefore, licensees should assure that technologists or other individuals performing dose calibrator checks understand: a) the applicable NRC regulations and specific license conditions; b) the purpose, method, and importance of these tests; and c) when follow-up actions are necessary. Licensees may wish to consider some type of audit or verification program to detect performance errors, including: failure to perform a test, inadequate evaluation of a test, or falsification of test records. Audits should include interviews with and observations of personnel performing their duties, as well as reviews of records to determine that the recorded results are correct. Licensees are reminded that they are held responsible for the acts of their employees and contractors. Willful failure to perform required dose cali- brator tests and falsification of records have resulted in civil penalties and orders modifying licenses to prohibit the involvement of individuals responsible for licensed activities. Willful violations can also result in criminal prosecution against both the licensee and individual employees. . IN 89-12 February 9, 1989 Page 3 of 3 No written response is required by this information notice. If you have any questions about this matter, please contact the appropriate NRC regional office or this office. Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Technical Contact: Sam Jones, NMSS (301) 492-0571 Attachments: 1. List of Recently Issued NMSS Information Notices 2. List of All Recently Issued NRC Information Notices . Attachment 2 IN 89-12 February 9, 1989 Page 1 of 1 LIST OF RECENTLY ISSUED NRC INFORMATION NOTICES _____________________________________________________________________________ Information Date of Notice No._____Subject_______________________Issuance_______Issued to________ 89-11 Failure of DC Motor-Operated 2/2/89 All holders of OLs Valves to Develop Rated or CPs for nuclear Torque Because of Improper power reactors. Cable Sizing 89-10 Undetected Installation 1/27/89 All holders of OLs Errors In Main Steam Line or CPs for BWRs. Pipe Tunnel Differential Temperature-Sensing Elements at Boiling Water Reactors. 89-09 Credit for Control Rods 1/26/89 All holders of OLs Without Scram Capability or CPs for test and in the Calculation of the research reactors. Shutdown Margin 89-08 Pump Damage Caused by 1/26/89 All holders of OLs Low-Flow Operation or CPs for nuclear power reactors. 89-07 Failures of Small-Diameter 1/25/89 All holders of OLs Tubing in Control Air, Fuel or CPs for nuclear Oil, and Lube Oil Systems power reactors. Which Render Emergency Diesel Generators Inoperable 89-06 Bent Anchor Bolts in 1/24/89 All holders of OLs Boiling Water Reactor or CPs for BWRs Torus Supports with Mark I steel torus shells. 89-05 Use of Deadly Force by 1/19/89 All holders of OLs Guards Protecting Nuclear for nuclear power Power Reactors Against reactors. Radiological Sabotage _____________________________________________________________________________ OL = Operating License CP = Construction Permit ..
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