Regulatory Compliance and Recordkeeping for a New Isotope
A department wants to begin using Lu-177 DOTATATE therapy. The radiation safety officer notes that the department's license currently authorizes only diagnostic isotopes. A technologist is asked to prepare a written directive and a QA plan. The department has a dose calibrator that was last calibrated 14 months ago; the manufacturer recommends annual calibration. The department also has a survey meter whose last calibration was 13 months ago; the regulatory requirement is annual calibration. The first patient is scheduled in 2 weeks.
1. Identify the compliance gaps and determine whether the first patient can proceed as scheduled.
Read the worked answer
Compliance gaps:
- License does not authorize Lu-177 DOTATATE therapy - a license amendment is required before use.
- Dose calibrator calibration is 14 months old, exceeding the annual recommendation - recalibrate before use.
- Survey meter calibration is 13 months old, exceeding the annual requirement - recalibrate before use.
- A written directive and QA plan are required for therapy.
The first patient cannot proceed in 2 weeks unless the license amendment is approved, the instruments are calibrated, and the written directive and QA plan are complete and approved. The schedule should be contingent on these items being closed out.
2. Outline the contents of the written directive and QA plan that must be in place before therapy.
Read the worked answer
Written directive should include:
- Patient identification.
- Isotope, chemical form, and route of administration.
- Prescribed dose and dose limits.
- Signature of the authorized user.
QA plan should include:
- Instrument calibration schedule (dose calibrator, survey meter).
- Dose verification and measurement procedures.
- Radiation safety procedures for staff, patient, and family.
- Waste handling and release criteria.
- Recordkeeping and audit schedule.
- Training and competency requirements.