Haw. Code R. § 11-45-142

Current through November, 2024
Section 11-45-142 - Assay of radiopharmaceutical dosages
(a) An assay shall be conducted, before medical use, of the activity of each radiopharmaceutical dosage that contains more than ten microcuries (three hundred seventy kilobecquerels) of a photon-emitting radionuclide;
(b) Radiopharmaceuticals emitting alpha and/or beta radiations as the radiation of principal interest shall be obtained:
(1) In unit dose form, calibrated by the supplier for individual patients; and
(2) From a supplier which participates in a measurement quality assurance program with the National Institute of Standards and Technology, and which is designed to ensure that unit doses have a calibration traceable to a national standard.
(c) The licensee shall retain a record of the assays or calibrations required by subsections (a) and (b). To satisfy this requirement, the record shall contain the:
(1) Radiopharmaceutical, or the radionuclide administered;
(2) Patient's name, and identification number if one has been assigned;
(3) Prescribed dosage and measured activity of the dosage at the time of assay, or a notation that the total activity was determined by a calibration traceable to a national standard;
(4) Date and time of the assay or calibration and the date and time of the administration; and
(5) Initials of the individual who performed the assay or documentation of the supplier's participation in the measurement quality assurance program.

Haw. Code R. § 11-45-142

[Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)