HAR §11-45-139. Quality control of diagnostic equipment

Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers and procedures which have been approved by the department. The licensee shall conduct quality control procedures in accordance with written procedures. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71) §11-45-140 Possession, use, calibration, and check of dose calibrators. (a) A medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient. In the case where the ionization type dose calibrator cannot be used effectively to verify administered activity, the licensee shall use an alternative method. Any alternative method for the use of a dose calibrator shall be approved by the department. Any alternative method shall provide for acceptable verification of constancy, accuracy, linearity, and geometry dependence as applicable. (b) Each licensee shall establish written quality control procedures for all dose calibrators used for measuring the amount of activity administered to a patient. As a minimum, quality control procedures and frequencies shall be those recommended by the American National Standards Institute: (1) Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the requirement of this section, the check shall be done on a frequently used setting with a sealed source of not less than fifty microcuries (1.85 megabecquerels) with energies representative of the radionuclides in clinical use at the facility; (2) Test each dose calibrator for accuracy upon §11-45-140 45-124 installation and at intervals not to exceed twelve months thereafter by assaying at least two sealed sources containing different radionuclides, the activity of which the manufacturer has determined within five percent of the stated activity, with minimum activity of fifty microcuries (1.85 megabecquerels) and energies representative of the radionuclides in clinical use at the facility; (3) Test each dose calibrator for linearity upon installation and at intervals not to exceed three months thereafter over the range of use between ten microcuries (three hundred seventy kilobecquerels) and the highest dosage that shall be assayed; and (4) Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it shall be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator. (c) A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds ten percent if the dosage is greater than ten microcuries (three hundred seventy kilobecquerels) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds ten percent. (d) A licensee shall also perform checks and tests required by subsection (b) following adjustment or repair of the dose calibrator. (e) A licensee shall retain a record of each check and test required by this section. The records required by subsection (b) shall include: (1) For subsection (b)(1), the model and serial number of the dose calibrator, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings, and the initials of the individual who performed the check; (2) For subsection (b)(2), the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, the instrument settings, and the signature of the individual who performed the test; (3) For subsection (b)(3), the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the signature of the radiation safety officer; and (4) For subsection (b)(4), the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, and the signature of the individual who performed the test. §11-45-142 45-125 (f) A licensee shall use dose calibrator reference and calibration sources traceable to the National Institute of Standards and Technology or other standards recognized as being equivalent by the National Institute of Standards and Technology. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)