Written Directive Requirements
USE OF RADIOPHARMACEUTICALS
The following are policies and procedures to be followed in the administration to patients of therapeutic radiopharmaceuticals or dosages of I-131 (Sodium Iodide) over 30 microcuries. If the person assigned to do any or all of the preparation and/or administration of radiopharmaceuticals does not understand any portion of a written directive, or a diagnostic procedure as approved by an authorized nuclear medicine physician, they are to stop and ask sufficient questions to adequately clarify the radiopharmaceutical, dose, route of administration, patient identity, and any related details before proceeding with the procedure.
Written Directives for Therapeutic Radio-pharmaceuticals, and Dosages of I-131 Sodium Iodide over 30 microCuries
A written directive must contain the patient’s name, radiopharmaceutical, dosage and route of administration and shall be signed and dated by an authorized nuclear medicine physician prior to preparation or administration of any therapeutic radiopharmaceutical, or dosage of I-131 Sodium Iodide over 30 microcuries.
Procedures for emergency oral directives (approved nuclear medicine consult), and written revision(s) to an existing written directives are given in 10 CFR 35.40(a)(1).
Copies of the written directives shall be retained for a period of three years after the date of administration, as set forth in 10 CFR 35.2040.
Patient Identification
Prior to administering the radiopharmaceutical, the person who is to administer the radiopharmaceutical will positively verify the identity of the patient or human research subject as the individual named in the written directive. Examples of positive patient identity verification include examining the patient ID bracelet, hospital ID card, driver’s license, or social security card.
Verification of Dose Prior to Administration
Prior to administering the radiopharmaceutical, the person who will do the administration is to verify that the details of the administration are in accordance with the written directive (or approved nuclear medicine consult). In addition to verifying the patient's identity, the radiopharmaceutical, dosage (activity), and the route of administration are to be verified to be in agreement with the written directive, or with the oral revision made by the authorized nuclear medicine physician's [written directive or revision of written directive must be obtained in accordance with 10 CFR 35.40(a)(1)]. The radiopharmaceutical activity is to be measured in a dose calibrator, and the results recorded and compared to the written directive.
Documentation of Administered Dose
The authorized physician, or a qualified individual under supervision of an authorized physician (nuclear medicine physician, physicist or technologist), shall make a record of the administration. The record will include the date, patient's name, radiopharmaceutical dosage, and signature or initials of the person administering the dose. The administration record is included on the same form with the written directive, and is available for audit. This form will include the following statement, or equivalent: "Retain record for three years following administration, as required by 10 CFR 35.2040."
BRACHYTHERAPY PROCEDURES
The following are policies and procedures to be followed in the use of radiation from brachytherapy sources for patient procedures. The use of sealed radioactive sources for brachytherapy procedures may involve one or more qualified persons (radiation therapy physicist, radiation therapy technologist, dosimetrist, oncology physician) working under the supervision of an authorized physician. Prior to the delivery of radiation from any brachytherapy source to a patient, there must be a written directive, see paragraph below. If at any point a supervised worker does not understand how to carry out the written directive, they are to stop and ask sufficient questions to clarify the procedures described in the written directive.
Written Directives
Prior to any administration of radiation from brachytherapy sources, an authorized physician will sign and date a written directive, and a treatment plan for the procedure. The written directive will include the patient's name, and before implantation: treatment site, the radionuclide, and dose to be delivered to the target area. After implantation but before completion of the procedure the written directive will include: the radionuclide, treatment site, number of sources, and total source strength, and exposure time (or the total dose). Procedures for emergency oral directives and revisions to written directives are given in 10 CFR 35.40(c).
Records of written directives and administration of each administered dose will be retained for a period of three years after the date of administration, as set forth in 10 CFR 35.2040.
Patient Identification
Prior to administering a brachytherapy dose, the patient’s or human research subject’s identity will be positively verified as the individual named in the written directive. Examples of positive patient identity verification include examining the patient ID bracelet, hospital ID card, driver’s license, or social security card.
Verification of Brachytherapy Plan of Administration
Before brachytherapy radioactive sources are administered, a qualified person such as a radiation therapy physicist, oncology physician, dosimetrist, or radiation therapy technologist, working under the supervision of an authorized physician will verify that the radioisotope, number of sources, and source strengths of the brachytherapy sources described in the plan of treatment are in agreement with the written directive. The person verifying agreement between the plan of treatment and the written directive will sign or initial and date the plan of treatment.
Checking Brachytherapy Dose Calculations
Before the total prescribed brachytherapy dose has been administered, an authorized physician or a qualified person such as a radiation therapy physicist, oncology physician, dosimetrist, or radiation therapy technologist, under the supervision of an authorized physician, will check the dose calculations for the brachytherapy procedure. Whenever possible, this will not be the same person who made the original calculations. Manual dose calculations will be checked for
- Arithmetic errors;
- Appropriate transfer of data from the written directive, plan of treatment, tables, and graphs;
- Appropriate use of nomograms;
- Appropriate use of all pertinent data in the calculations.
If available, printouts from computer-generated dose calculations will be checked to verify that the correct data was used in the calculations, including position of the applicator or sealed sources, isotope, number of sources, total source strength, or source loading sequence. Checking may also be done by using manual calculations of a radiation dose to a single key point, with comparison to the computer generated dose calculations. In the cases where radiation doses are calculated during a combination of computer generated output and manual calculation, verifying will include checking that the correct output from one type of calculation is properly used as the input for the other type of calculation.
Verification of Brachytherapy Source Administration
Prior to administering brachytherapy sources, a qualified person, such as a radiation therapy physicist, oncology physician, dosimetrist, or radiation therapy technologist, under the supervision of an authorized physician will verify that the radioisotopes, number of sources, source strengths, and if applicable, loading sequence of the sources to be used are in agreement with the written directive and plan of treatment. The verification method will be appropriate to the sources used, and may include checking the serial number of sealed sources behind an appropriate shield, using a dose calibrator, observing color codes on the sources, monitoring radiation output of the sources with a radiation detector, or using clearly marked storage locations where separate storage areas are used for different source strengths.
Recording Application of Temporary Brachytherapy Implant Sources
After insertion of temporary implant brachytherapy sources, an authorized physician will promptly record the radionuclide, treatment site, number of sources, and total source strength, and exposure time (or the total dose). This form will be in the patient's chart or other appropriate record, and will be signed or initialed by the authorized physician. This form will include the following statement, or equivalent: "Retain record for three years following administration, as required by 10 CFR 35.2040."
Permanent Brachytherapy Source Position and Total Dose Verification
For permanent brachytherapy implants, x-ray imaging of the sources in place will be performed as a basis for verifying the position of the source and calculating the total dose. If applicable, this x-ray imaging will be done after inserting the sources into the patient. In cases where fixed geometry applicators or templates are used, x-ray imaging of the source positions in the patient is not mandatory. Immediately after implanting sources in the patient, survey of the patient and the surrounding area will be made to confirm no sources are unintentionally located outside of the patient.
Recording Application of Permanent Brachytherapy Implant Sources
After insertion of permanent implant brachytherapy sources, an authorized physician will promptly record the radionuclide, treatment site, number of sources, and total source strength. This form will be in the patient's chart or other appropriate record, and will be signed or initialed by the authorized physician. This form will include the following statement, or equivalent: "Retain record for three years following administration, as required by 10 CFR 35.2040"
Brachytherapy for Emergency Medical Conditions
If an authorized physician determines that delaying brachytherapy treatment in order to perform the checks of dose calculations would jeopardize the patient's health because of the emergent nature of the patient's medical condition, the checks of the calculations will be performed within two working days of completion of the brachytherapy treatment.
Acceptance Testing of Brachytherapy Dose Planning Computer Programs
Before the first use of treatment planning or dose calculating computer programs for brachytherapy dose calculations, acceptance testing of the programs will be performed by a qualified person. The functions of the computer programs evaluated during acceptance testing will include the dose and spatial accuracy of calculations in tissue for at least those brachytherapy procedures clinically performed by authorized physicians under this license.
PERIODIC REVIEW OF MEDICAL USES OF BYPRODUCT MATERIALS
In accordance with 10 CFR 35.41 we will develop, implement, and maintain procedures to conduct periodic reviews of each applicable program area, e.g., radiopharmaceutical therapy and implant brachytherapy. The number of patient cases to be sampled will be based on the principles of statistical acceptance sampling and will represent each treatment modality performed in the institution, e.g., radiopharmaceutical and brachytherapy.
These reviews will be performed by a HP, medical physicist, or other qualified person. If possible, the persons conducting the review will not review their own work. The findings of the periodic reviews will be reported at the meetings of the Medical Quorum of the RSC to ensure that the procedures for administrations requiring a written directive are effective.
A determination will be made as to whether the administered radiopharmaceutical dosage or radiation dose was in accordance with the written directive or treatment plan, as applicable. For each patient case reviewed, deviations from the written directive, the cause of each deviation, and the action required to prevent recurrence will be identified.
RECORDS FOR PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIRECTIVE
A copy of the procedures for administrations requiring a written directive shall be retained for the duration of the license.
REPORTS OF MEDICAL EVENTS
The RSO will notify the NRC Operations Center no later than the next calendar day after discovery of the medical event and submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after the discovery of the medical event, as required by 10 CFR 35 3045. The RSO will also notify the referring physician and the patient as required by 10 CFR 35.3045.
Page last updated on June 7, 2019.
