Written Directive “an authorized user’s written order for the administration of byproduct* material or radiation from by product material to a specific patient or human research subject, as specified in § 35.40” *Any reference to “Byproduct material” in 10 CFR 35 is replaced by the term “Radioactive material” as defined in CCR (r)

§ Written Directives The AU must sign and date the WD before administering: I-131 greater than 30 uCi Any therapeutic dosage of unsealed radioactive material Any therapeutic dose of radiation from solid or sealed radioactive material

Therapeutic Dosage Therapeutic dosage means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

Therapeutic Dose Therapeutic dose means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

Oral Directive Acceptable if due to the patient’s condition, a delay in the order to provide a written directive would jeopardize the patient’s health. OD Information must be documented in the patient’s record ASAP A WD must be prepared within 48 hours of the oral directive

The Written Directive must contain the following information: The dosage of I-131 for any quantity greater than 30 uCi For other therapeutic administration of unsealed radioactive material: Radioactive drug Dosage Route of administration

Written Directive for GSR Total dose Treatment site Values for the target coordinate settings per treatment for each anatomically distinct treatment site

Written Directive for HDR Brachytherapy Radionuclide Treatment site Dose per fraction Number of fractions Total dose

Written Directive for Teletherapy Dose per fraction Number of fractions Treatment Site Total dose

Written Directive for all other Brachytherapy (low, medium, pulsed) Before implantation: –treatment site –radionuclide –dose After implantation but before completion of the procedure: –radionuclide –treatment site –number of sources –total source strength and exposure time (or total dose)

Written revision to WD allowed if signed and dated by the AU before the administration of: The dosage of unsealed radioactive material The brachytherapy dose GSR dose Teletherapy dose Next fractional dose

Oral revision allowed for existing written directive If necessary for patient’s health Must be documented ASAP in the patient’s record Must be signed and filed within 48 hours

Procedures for Administrations Requiring a Written Directive (§35.41)

Licensee shall develop, implement and maintain written procedures to provide high confidence that: Patient’s identity is verified before each administration Each administration is in accordance with written directive

At a minimum, the procedures must address the following Verifying the identity of the patient or human subject Verifying that the administration is in accordance with the treatment plan (if applicable) and the WD Checking both manual and computer generated dose calculations and Verifying that any computer generated dose calculations are correctly transferred into the console of the therapeutic medical units

Records All written directives must be kept on file for 3 years (10 CFR ) Licensee must retain a copy of the WD procedures for 3 years (10 CFR )

Violations Associated with Written Directives Most common violations pertain to Procedures for Administrations Requiring a Written Directive (§35.41)

Enforcement Action Example 1 On June 2, 2010, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $14,000 to the Department of Veterans Affairs for two Severity Level III violations identified as a result of a medical event that occurred at the San Diego Healthcare System facility. The medical event resulted when iodine-131 was injected into the wrong port of the gastrostomy feeding tube (g- tube) resulting in an underdose to the patient’s thyroid and an unintended dose to the patient’s stomach. Specifically, the licensee’s written procedures did not include directions for administering byproduct material through a g-tube to ensure that the administered dose was in accordance with the written directive as required by 10 CFR 35.41(a)(2).

Example 1, continued Additionally, two nuclear medicine technologists had not been instructed on administering byproduct material through a g-tube prior to performing the administration in order to ensure that the administered dose was in accordance with the written directive. The second Severity Level III violation involved the licensee’s failure to notify the NRC Operations Center no later than the next calendar day after discovery of a medical event as required by 10 CFR (c). Specifically, on September 23, 2009, the licensee had sufficient information, based on patient survey data and the image from the nuclear medicine department, to report the medical event and did not notify the NRC until September 26, 2009.

Enforcement Action Example 2 On January 21, 2010, the NRC issued a Notice of Violation to CJW Medical Center - Johnston-Willis Campus for a violation of 10 CFR 35.41(a)(2) associated with a Severity Level III violation involving the failure to develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with written directives. Specifically, as of December 16, 2008, the licensee's procedures (GSR) did not require verification of the treatment site nor resolution of any inconsistencies in the written directive prior to administration of the dose. This resulted in a patient receiving treatment to the left trigeminal nerve instead of to the originally-intended site (right trigeminal nerve).

Enforcement Action Example 3 On October 10, 2008, a Notice of Violation was issued for three Severity Level III violations. The first violation involved a failure to meet 10 CFR 35.41(b)(2) requirement. Specifically, the licensee did not develop and implement written procedures to provide high confidence that each medical administration is in accordance with the written directive, in that the procedures did not address response to high dose rate (HDR) device error messages.

Other example involving 10 CFR 35.40: On May 12, 2008, a Notice of Violation issued for a Severity Level III violation, involved two written directives not dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 30 uCi. Specifically, on April 30, 2007, two nuclear medicine technologists administered I 131 sodium iodide to two patients, without a dated and signed written directive.

Other NRC Enforcement Actions See Link:

In Summary Written Directives are prescriptions for treatment and must be signed and dated by the AU Oral directives allowed in some cases Procedures for administrations requiring a written directive are very important for providing high confidence that treatment is performed successfully.