Written Directive Requirements

Key Facts

U.S. NRC Regulations Title 10, Code of Federal Regulations

• Written directive must be dated and signed by an authorized user (AU) before administration of

I-131 sodium iodide > 30 µCi (1.11 MBq)

Any therapeutic dosage of unsealed byproduct material, or

Any therapeutic dose of radiation from byproduct material
• If, because of emergent nature of patient’s condition, a delay in order to provide a written directive would jeopardize patient’s health, oral directive is acceptable

Information contained in oral directive must be documented as soon as possible in writing in patient’s record

Written directive must be prepared within 48 hours of oral directive
• Written directive must contain patient or human research subject’s name and the following information

Dosage of any administration of quantities > 30 µCi (1.11 MBq) of sodium iodide I-131

For administration of therapeutic dosage of unsealed byproduct material other than sodium iodide I-131

– Radioactive drug, dosage, and route of administration
• Written revision to existing written directive may be made if revision is dated and signed by an AU before administration of dosage of unsealed byproduct material
• If, because of patient’s condition, a delay in order to provide a written revision to existing written directive would jeopardize patient’s health, oral revision to existing written directive is acceptable

Oral revision must be documented as soon as possible in patient’s record

Revised written directive must be signed by AU within 48 hours of oral revision
• Licensee shall retain copy of written directive for 3 years

Key Images

Sample written directive for administration of I-131 NaI is shown. Note that an authorized user must prescribe the dose and sign the form at the time of administration. This form must be kept for 3 years.

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May 7, 2023 | Posted by admin in CARDIOVASCULAR IMAGING | Comments Off

Key Facts

U.S. NRC Regulations Title 10, Code of Federal Regulations

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Written Directive Requirements

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Written Directive Requirements

Key Facts

U.S. NRC Regulations Title 10, Code of Federal Regulations

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