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Radiopharmaceutical Therapy Dose Documentation Form

Radiopharmaceutical Therapy Dose Documentation Form

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<strong>Radiopharmaceutical</strong> <strong>Therapy</strong> <strong>Dose</strong> <strong>Documentation</strong> <strong>Form</strong><br />

I-131 Sodium Iodide<br />

A. WRITTEN DIRECTIVE:<br />

1. Pt Name: 2. MR#: 3. Female Male<br />

4. <strong>Radiopharmaceutical</strong> (Including Isotope): 5. <strong>Dose</strong> in mCi:<br />

6. Date of Administration: 7. Time of Administration: 8. Route of Administration:<br />

9. Clinical Research (Protocol Number: )<br />

10. Indication: 11. Patient Meets Criteria for this Radiotherapy<br />

12. Other therapy treatment within the past year NO YES (if yes, complete section F. Repeat Treatment)<br />

13. Signature of Authorized MD 14. Date___________& Time_______ Signed<br />

Verified by (initial): ____________<br />

NOTE: Must NOT be the individual who signed the written directive.<br />

MUST be Nuclear Pharmacist, Authorized User Physician, or Med Physicist.<br />

B. PATIENT INFORMATION/EDUCATION VERIFICATION:<br />

(NOTE: To be completed by the Authorized User)<br />

Pt ID Verification (2 methods used; Name must be 1 of the 2)<br />

Completed by (initial): ____________<br />

Check: Name AND Birthdate MR#<br />

Completed by (initial): ____________<br />

Completed by (initial): ____________<br />

Completed by (initial): ____________<br />

Prescribing physician explained dose and treatment to administering clinician.<br />

Negative pregnancy test or excluding clinical condition confirmed with reasonable<br />

assurance<br />

Patient is not currently breast feeding.<br />

Completed by (initial): ____________<br />

Completed by (initial): ____________<br />

Informed consent obtained or verified<br />

Written radiation safety instructions provided. If the patient will receive I-131, the<br />

radiation safety checklist in the “Health Facts for You” has been reviewed with the<br />

patient and the specific instructions identified.<br />

C. PHARMACY COMPUTER ORDER ENTRY DOCUMENTATION:<br />

Persons performing this task MUST be Pharmacy Technician Pharmacist Nuclear Medicine Technologist Physician<br />

Completed by (initial): ____________<br />

Verified by (initial): ______________<br />

NOTE: Person verifying this task must NOT be the individual who did the pharmacy computer<br />

order entry.<br />

D. DOSE PREPARATION DOCUMENTATION:<br />

Persons performing this task MUST be Pharmacy Technician Pharmacist Nuclear Medicine Technologist Physician<br />

Completed by (initial): ____________<br />

NOTE: Must NOT be the individual administering the product.<br />

<strong>Dose</strong> Assay (mCi) = ______________ Assay Date _______________ & Time ___________ RX# ___________________<br />

Verified by (initial): ______________<br />

NOTE: Must NOT be the individual who did the preparation, NOR the one administering.<br />

<strong>Dose</strong> Assay (mCi) = ______________ Assay Date _______________ & Time ___________ RX# ___________________<br />

Side 1 of 2


E. I-131 THERAPY PATIENT RELEASE JUSTIFICATION RECORD for Exposure from the Patient<br />

RADIATION DOSE TO AN INDIVIDUAL EXPOSED TO PATIENT MUST BE < 500 mrem<br />

(Note: Complete either section 1, 2, 3, OR 4, as applicable.<br />

1. Patient with Thyroid (Assumes 100% whole body retention, dose MUST BE < 33 mCi for patient release):<br />

Estimated maximum dose to an individual exposed to patient.<br />

___________ mrem<br />

(15.15 x administered mCi) Using Appendix U, Table 14, WisReg 1556, Vol 9.<br />

2. Hyperthyroid Thyroid <strong>Therapy</strong> (Thyroid uptake < 40% or lower (E*), dose MUST BE < 56 mCi for patient release):<br />

* Assumes 0.125 Occupancy Factor (E), patient lives alone and few visits by family & friends for at least the first 2 days.<br />

Estimated maximum dose to an individual exposed to patient.<br />

___________ mrem<br />

(8.84 x administered mCi) Using Appendix U, Equation B-5, WisReg 1556, Vol 9.<br />

3. Patient Post-Thyroidectomy (dose MUST BE < 220 mCi for patient release):<br />

___________ mrem<br />

Estimated maximum dose to an individual exposed to patient.<br />

(2.27 x administered mCi) Using Appendix U, Equation B-5, WisReg 1556, Vol 9.<br />

4. Patient Specific Calculations (Calculations MUST BE APPROVED by Authorized Physician<br />

___________ mrem<br />

Estimated maximum dose to an individual exposed to patient. (Must be < 500 mrem for patient release)<br />

Using patient specific calculations, Using Appendix U, Equation B-5, WisReg 1556, Vol 9.<br />

(Attach spreadsheet used to aid in the calculation: J:/Nuclear/NuclearPharmacy/NRC & Safety & Dosimetry/I131<br />

Exposure/I-131 Thyroid Cancer Exposure Calculation.xls)<br />

F. Repeat Treatments (Refer to Section A. WRITTEN DIRECTIVE, Item No. 12)<br />

Is this repeat therapy<br />

treatment within a<br />

year?<br />

___________ mrem<br />

NO (SKIP this section, if NO is checked)<br />

YES (Estimated dose to an individual exposed to patient due to other treatment ____ mrem)<br />

TOTAL Estimated dose to an individual exposed to patient from other therapy treatments. (The sum of mrems<br />

from 1, 2, 3, or 4 to dose from other treatments within one year MUST be < 500 mrem for patient release)<br />

G. ADMINISTRATION VERIFICATION (NOTE: To be completed at the time of treatment)<br />

Persons performing this task MUST be Pharmacy Technician Pharmacist Nuclear Medicine Technologist Physician<br />

Authorized User Physician<br />

Clinician<br />

#1<br />

<br />

Initial<br />

_______<br />

Initial<br />

_______<br />

Initial<br />

_______<br />

Initial<br />

_______<br />

Initial<br />

_______<br />

Initial<br />

_______<br />

Initial<br />

_______<br />

Clinician<br />

#2<br />

<br />

Initial<br />

_______<br />

Clinician #1 is the Administering Clinician who is giving the dose.<br />

Clinician #2 is NOT administering the dose.<br />

Clinician #1 reads aloud the patient name, radiopharmaceutical and dose from the product label.<br />

Clinician #2 reviews the written directive and verifies that the following match (check as done):<br />

Patient Name <strong>Radiopharmaceutical</strong> <strong>Dose</strong><br />

Clinician #1 Clinician #2 assays the dose in the dose calibrator. NOTE: Must NOT be the individual<br />

who did the preparation, NOR the one who verified the product.<br />

<strong>Dose</strong> Assay (mCi) = ___________________ Date _________________ Time ______________<br />

(also document assay, time, date, initials on the computer generated prescription)<br />

Pt ID Verification (2 methods used; Name must be 1 of the 2) Check: Name AND Birthdate MR#<br />

Negative pregnancy test or excluding clinical condition confirmed with reasonable assurance.<br />

Patient is not currently breast feeding.<br />

<strong>Dose</strong> administered to patient.<br />

Patient released at the time of administration. YES NO<br />

Clinician #1 Signature ______________________________________ Date________________ Time___________________<br />

Side 2 of 2<br />

Initials on file in Nuclear Medicine Procedure Manual Version date 11/11/08; Updated 12/14/09

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