N.H. Admin. Code § He-P 4035.13

Current through Register No. 50, December 12, 2024

Section He-P 4035.13 - Written Directives and Procedures for Administrations Requiring a Written Directive

(a) A written directive shall be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any therapeutic dosage of unsealed byproduct material, or any therapeutic dose of radiation from byproduct material.

(b) If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible, in writing, in the patient's record. A written directive shall be prepared within 48 hours of the oral directive.

(c) The written directive shall contain the patient or human research subject's name and the following information:

(1) For any administration of quantities greater than 1.11 megabecquerel (30 microcuries) of sodium iodide I-131: the dosage;

(2) For an administration of a therapeutic dosage of unsealed byproduct material other than sodium iodide I-131: the radioactive drug, dosage, and route of administration;

(3) For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

(4) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;

(5) For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;

(6) For permanent implant brachytherapy:

a. Before implantation: treatment site, the radionuclide, and the total source strength; and

b. After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength, and the date; or

(7) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

a. Before implantation: the treatment site, the radionuclide, and dose; and

b. After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose).

(d) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

(e) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing directive shall be acceptable.

(f) The oral directive shall be documented as soon as possible in the patient's record. A revised written directive shall be signed by the authorized user within 48 hours of the oral revision.

(g) The licensee shall retain a copy of each written directive in accordance with He-P 4035.13 for 3 years.

(h) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

(1) The patient or human subject's identity is verified before each administration; and

(2) Each administration is in accordance with the written directive.

(i) At a minimum, the procedures required by He-P 4035.13(h) shall address the following items that are applicable to the licensee's use of byproduct material:

(1) Verifying the identity of the patient or human research subject;

(2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

(3) Checking both manual and computer-generated dose calculations;

(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by He-P 4035.29 or He-P 4035.47;

(5) Determining if a medical event, as defined in He-P 4035.14, has occurred; and

(6) Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

(j) A licensee shall retain a copy of the procedures under He-P 4035.13(h) for the duration of the license.

N.H. Admin. Code § He-P 4035.13

(See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07

Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10897, Effective 7/22/2015, Expires1/18/2016.

Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11011, Effective 1/15/2016, Expires 1/15/2026.

Amended by Volume XXXVI Number 23, Filed June 9, 2016, Proposed by #11108, Effective 5/25/2016, Expires 5/25/2026.

Amended by Volume XXXVI Number 49, Filed December 8, 2016, Proposed by #12054, Effective 11/19/2016, Expires 11/19/2026.

Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.

Amended by Volume XLII Number 45, Filed November 10, 2022, Proposed by #13473, Effective 10/25/2022, Expires 10/25/2032