§ 175.62 Therapeutic Radiation Machines – Quality Assurance Requirements.
RCNY § 175.62
Each registrant or applicant subject to the requirements of 24 RCNY Health Code §§ 175.64, 175.65 or 175.69 must develop, implement and maintain a quality assurance program to provide assurance that radiation will be administered as directed by the authorized user.
(a)The quality assurance program must include all of the policies and procedures listed in 24 RCNY Health Code § 175.108(c). In addition, the written directive described in 24 RCNY Health Code § 175.108(c)(2)(ii) must contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site and number of fractions. The registrant must retain a copy of the written directive for 3 years.
(b)Each registrant must adopt and maintain a radiation treatment planning manual prepared by a QMP. The manual must include the calculation methods and formulas to be used at the facility. The treatment planning manual shall be part of the registrant's quality assurance program required by subdivision (a) of this section. The radiation treatment manual must be included in training given pursuant to 24 RCNY Health Code § 175.11(c) to facility staff who will participate in treatment planning. Each registrant must ensure that a QMP reviews and approves the treatment planning manual at least annually.
(c)Accreditation in radiation oncology (except superficial therapeutic x-ray units).
(1)Each registrant must have an active application with, or be accredited in radiation oncology by the American College of Radiology or the American College of Radiation Oncology or the American Society for Radiation Oncology or another accrediting organization that is equivalent as determined by the Department.
(2)The registrant must maintain a record of accreditation, including a copy of the application, all supplemental application information and all correspondence transmitted between the accrediting body and the registrant or licensee. Records must be maintained for at least 6 years.
(d)A certified registrant must make a record of, but not report, a therapeutic radiation dose when errors in computation, calibration, time of exposure, treatment geometry or equipment malfunction result in a calculated total treatment dose differing from the final prescribed total treatment dose ordered by more than 10 percent.
(e)A certified registrant must report any event resulting from intervention of a patient or human research subject in which the administration of radiation results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician. (Added City Record 4/24/2019, eff. 5/24/2019)
