The Missing Dosimetry Records and the Auditors
A medical facility uses a 20 Ci cesium-137 blood irradiator. The facility is licensed by an Agreement State. The radiation safety officer (RSO) maintains dosimetry records for all occupationally exposed workers. During a routine audit, the auditor requests dosimetry records for the past three years for all workers. The RSO provides records for the current year but admits that records for the previous two years were lost when the facility switched to a new electronic recordkeeping system. The RSO states that the old system was not backed up and the records were not transferred. The auditor also finds that the facility's written radiation protection program does not include a record retention policy. The RSO argues that the records are not required because the workers' doses were well below regulatory limits. The auditor is concerned about compliance with recordkeeping requirements and the potential inability to demonstrate compliance.
1. What are the regulatory requirements for recordkeeping of dosimetry records, and did the facility violate them?
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Under 10 CFR 20.2106 (or equivalent Agreement State regulations), licensees must maintain records of individual monitoring for at least three years, or until the regulator terminates the license, whichever is longer. The records must include the doses received by each monitored individual. The facility lost two years of records, so it cannot demonstrate compliance for that period. The RSO's argument that the doses were below limits is irrelevant; the requirement is to maintain records, not just to stay below limits. The facility violated the recordkeeping requirement by failing to retain the records for the required period. Additionally, the lack of a record retention policy in the radiation protection program is a violation of 10 CFR 20.1101, which requires a written program that includes recordkeeping procedures. The facility must reconstruct the records if possible or acknowledge the loss and take corrective action.
2. What corrective actions should the facility take to address the lost records and prevent recurrence?
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Corrective actions: (1) Attempt to reconstruct the lost dosimetry records from secondary sources such as dosimetry vendor records, payroll records, or individual dose histories. (2) Document the loss and the reconstruction efforts. (3) Implement a record retention policy that complies with regulatory requirements, including backup and transfer procedures for electronic records. (4) Revise the radiation protection program to include the record retention policy. (5) Train staff on recordkeeping requirements. (6) Notify the regulator of the lost records and the corrective actions taken. (7) Conduct an audit of all other required records to ensure they are complete. (8) Consider implementing a redundant recordkeeping system. The facility should also evaluate whether the lost records affect the ability to demonstrate compliance with dose limits, and if so, take additional measures such as individual dose assessments.