Define
Therapy, patient volume, responsible departments, locations, current license, regulator, and target date.
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Theranostics Program Readiness Checklist
A facility-level starting point for urology, oncology, nuclear medicine, radiology, hospitals, and other medical practices preparing to offer radiopharmaceutical therapy or radioligand therapy.
Readiness workstreams
Questions to answer before launch
The checklist is not a clinical protocol. It organizes facility, radiation-safety, licensing, and operational decisions for the responsible professionals and licensee.
- Therapy and anticipated volume: identify the intended radiopharmaceutical therapy, isotope and use, expected patient volume, referral pathway, and proposed start date. Examples may include Pluvicto (lutetium Lu-177 vipivotide tetraxetan) or Lutathera (lutetium Lu-177 dotatate).
- Regulatory authority: determine whether the facility is regulated by the NRC or an Agreement State and identify the current license number, expiration, and amendment process.
- Current license authorization: review authorized materials, uses, quantities, locations, and license conditions against the proposed program.
- Authorized personnel: identify the proposed Authorized User, Radiation Safety Officer, required training and experience records, coverage model, and whether personnel changes are needed.
- Facility locations: map ordering and receipt, secure storage, preparation, administration, patient occupancy, surveys, waste holding, and discharge pathways.
- Radiation protection: define shielding or occupancy evaluation needs, contamination controls, survey instruments, dose calibrator or other measurement equipment, calibration, and personnel monitoring.
- Written procedures: organize ordering, receipt, security, preparation, administration, written directive, surveys, spills, emergencies, medical events, waste, records, and required notifications.
- Patient workflow: assign responsibilities from referral and scheduling through arrival, administration, observation, release instructions, follow-up, and communication. Clinical decisions belong to the authorized clinical team.
- Waste and contamination: define decay-in-storage or other authorized disposal processes, collection locations, labels, surveys, release records, and response to contamination.
- Training and drills: identify staff by role and document radiation-safety, handling, spill, emergency, patient-release, and program-specific training before go-live.
- Vendor and logistics: confirm ordering lead times, delivery windows, receiving responsibilities, cancellations, dose changes, transport within the facility, and contingency plans.
- Go-live criteria: create a written readiness review covering license authorization, personnel, rooms, equipment, procedures, training, vendor logistics, emergency preparation, and open corrective actions.
Program sequence
Four connected stages
Gap review
Compare current authorization, personnel, rooms, equipment, procedures, training, and workflow to the proposed use.
Prepare
Complete the appropriate amendment or internal change process, facility work, documentation, staff training, and vendor coordination.
Verify
Confirm approvals and readiness, resolve open items, run the operational workflow, and define ongoing audits and QC.
Official references
Start with the regulator and current license.
NRC Medical-Use Toolkit
Use the NRC Medical-Use Licensee Toolkit and applicable Agreement State resources to identify current requirements.
NUREG-1556, Volume 9
Review the NRC's current program-specific guidance for medical-use licenses.
SNMMI professional resources
See SNMMI Theranostics Central professional resources for additional professional material.
Technical review: reviewed by an ABR-certified diagnostic medical physicist. Last reviewed September 2026. This educational checklist is not medical or legal advice and does not replace the decisions of the licensee, RSO, Authorized User, regulator, or clinical team.
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