§ 175.108 Quality Assurance Programs.
RCNY § 175.108
(a)Purpose and scope. This section establishes requirements for the use of radioactive materials or the radiation therefrom for diagnostic and therapeutic uses in the healing arts. These requirements provide for the protection of the public health and safety and are in addition to, and not in substitution for, other requirements in this Article. The requirements of this section apply to all licensees subject to this Article.
(b)Diagnostic facilities. A quality assurance program is a system of plans, actions, reviews, reports and records, the purpose of which is to ensure that diagnostic facilities achieve consistent high quality imaging and other diagnostic results, while maintaining personnel doses within limits prescribed by the Department.
(1)Each licensee performing diagnostic procedures must implement a quality assurance program, which includes at a minimum: (i) the adoption of a manual containing written policies and procedures for radiation protection and describing the licensee's quality assurance program that is facility- and equipment-specific. Policies and processes must be consistent with the types of procedures provided including, but not limited to, identification of patients, personnel monitoring, and protection of pregnant workers and patients. The quality assurance manual must describe the various processing, generator and systems quality control tests appropriate for the types of procedures provided in sufficient detail to ensure that they will be performed properly; (ii) the performance of quality control tests and the correction of deficiencies as specified in the quality assurance manual; (iii) the provisions of a formalized in-service training program for employees including, but not limited to, quality assurance and radiation safety procedures; (iv) the measurement of the amount of activity of each dose of a radiopharmaceutical/ radiobiologic administered to each patient; (v) the provision of the information described in 24 RCNY Health Code § 175.108(b)(1)(iv) to any patient upon request; and (vi) the performance of an ongoing program of analysis of repeated, rejected or wrongly administered diagnostic studies which are designed to identify and correct problems and to optimize quality.
(2)Each licensee must maintain written records documenting quality assurance and audit activities for review by the Department. Unless otherwise required, such records must be maintained by the licensee until after the next scheduled inspection is completed by the Department.
(c)External beam and brachytherapy. A quality assurance program for external beam therapy or brachytherapy is a system of plans, actions, reviews, reports and records, the purpose of which is to ensure a consistent and safe fulfillment of the dose prescription to the target volume with minimal dose to normal tissue.
(ii)A written directive or dated order or prescription for the medical use of radiation or radioactive material must be made for each patient in accordance with 10 C.F.R. § 35.40. The directive, order or prescription must be signed or approved electronically by a board certified radiation oncologist or qualified physician who restricts their practice to radiation oncology.
(iii)The accuracy of treatment plan data and any modifications to treatment plan data transferred to a radiation treatment delivery system must be verified by qualified clinical staff prior to patient treatment.
(iv)A radiation therapy technologist, physician or other qualified health practitioner must verify that the patient set up on the treatment machine is in accordance with the treatment plan prior to the first fraction of a course of treatment and prior to treatment for any changes to the initial treatment plan.
(v)Clinical staff must obtain clarification before beginning a patient's treatment if any element of the order or other record is confusing, ambiguous, erroneous or suspected of being erroneous.
(vi)Each patient's identification must be verified by at least two different means by qualified clinical staff prior to each treatment.
(vii)Each patient's response to treatment must be assessed by a board certified radiation oncologist or other qualified physician in the active practice of external beam therapy or brachytherapy. Unusual responses must be evaluated as possible indications of treatment errors and recorded in the patient's medical record.
(viii)The medical records of patients undergoing fractionated treatment must be checked for completeness and accuracy by qualified clinical staff at intervals not to exceed six fractions.
(ix)Radiation treatment plans and related calculations must be checked by qualified clinical staff for accuracy before 25 percent of the prescribed dose for external beam therapy or 50 percent of the prescribed dose for brachytherapy is administered, except the check must be performed prior to treatment for: any single fraction treatment; any fractional dose that exceeds 300cGy or 700 monitor units; or when the output of a medical therapy accelerator exceeds 600 monitor units per minute during treatment. If a treatment plan and related calculations were originally prepared by a board certified radiation oncologist or an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51, it may be rechecked by the same individual using a different calculation method. Treatment plans and related calculations prepared by other qualified clinical personnel must be checked by a second qualified person using procedures specified in the treatment planning procedures manual required pursuant to paragraph (3) of this subdivision and who has received training in use of this manual.
(x)All equipment and other technology used in planning and administering radiation therapy must function properly and safely, and must be calibrated properly and repaired and maintained in accordance with the manufacturer's instructions. The equipment and technology that is subject to such quality control, includes but is not limited to: computer software and hardware including upgrades and new releases; equipment used to perform simulation; dosimetry equipment; equipment used to guide treatment delivery, including but not limited to ultrasound units, kV and mV imaging equipment and monitors that are used to view patient imaging studies and personnel radiation safety equipment. Data communication between various systems, including but not limited to treatment planning systems, treatment delivery systems and data networks/storage media must be evaluated and tested to ensure accurate and complete data transfer.
(xi)Quality control tests performed on equipment and technology used in planning and implementing radiation treatment must be documented, including: (A) Detailed procedures for performing each test; (B) The frequency of each test; (C) Acceptable results for each test; (D) Corrective actions taken; (E) Record keeping and reporting procedures for test results including the tester's name, signature and date of the test; and (F) The qualifications are specified for the individual conducting the test and for the person who reviews test data.
(xii)Test results that exceed tolerances/limits must be immediately reported to the authorized medical physicist or QMP.
(xiii)Records for all maintenance, repairs and upgrades of equipment and technology must be maintained for at least 5 years.
(xiv)Errors or defects in technology or equipment, including computer hardware and software, must be reported to the technology or equipment manufacturer and to the United States Food and Drug Administration (MedWatch) as soon as possible and in no event more than 30 days of discovery, and records of equipment errors and reports required by this subparagraph must be maintained for review by the Department for at least 3 years.
(xv)Patients with permanent brachytherapy implants must be provided with instructions to take radiation safety precautions, as required by 10 C.F.R. § 35.75 and the licensee's radioactive materials license, after being released from the licensee's facility.
(xvi)All personnel involved in planning or implementing radiation therapy must be credentialed and acting within their scope of practice as provided in New York State law. Credentialing must include verifying that all professional staff are appropriately licensed, including medical physicists and radiation therapy technologists. Records of credentialing must be maintained during the period in which the credentialed person provides services to the licensee or registrant, and for 3 years thereafter.
(xvii)Any unintended deviation from the treatment plan that is identified must be evaluated and corrective action to prevent recurrence must be implemented. Records of unintended deviations and corrective action must be maintained for audits required by paragraph (5) of this subdivision and for review by the Department.
(xviii)There must be a process to ensure quick and effective response to any radiation therapy related recalls, notices, safety alerts and hazards.
(3)Each licensee must adopt and maintain a radiation treatment manual prepared by an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51. The manual must include the calculation methods and formulas to be used at the facility (including the methods for performing the checks of treatment plans and related calculations as required by clause (I) of subparagraph (i) of paragraph (3) of this subdivision). The treatment planning manual may be part of the quality assurance manual. The radiation treatment manual must be included in training given pursuant to 10 C.F.R. § 19.12 to facility staff who will participate in treatment planning. Each licensee must ensure that an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51 prepares or reviews and approves a procedures manual describing how radiation therapy treatment planning is to be performed at the licensee's facility and reviews the treatment planning manual at least annually.
(4)Each licensee must ensure that all equipment used in planning and administering radiation therapy is functioning properly, designed for the intended purpose, properly calibrated, and maintained in accordance with the manufacturer's instructions and the quality assurance program described in the licensee's quality assurance manual. Such equipment must be calibrated prior to use on patients, at least annually thereafter and following any change, repair or replacement of any component which may alter the radiation output.
(5)Each licensee must implement written procedures for auditing the effectiveness of the radiation therapy quality assurance program that includes the following: (i) Audits must be conducted at intervals not to exceed 12 months by an authorized medical physicist possessing the qualifications specified in 10 C.F.R. § 35.51, and also by a physician, both of whom are in the active practice of the type of radiation therapy conducted by the licensee; and (ii) The licensee must ensure that the individuals who conduct the audit prepare and deliver to the licensee a report which contains an assessment of the effectiveness of the quality assurance program and makes recommendations for any needed modifications or improvements; and (iii) The licensee must promptly review the audit findings, address the need for modifications or improvements and document actions taken. If recommendations are not acted on, the licensee must document the reasons therefor and also any alternative actions taken to address the audit findings; and (iv) Each licensee must maintain complete written records relating to quality assurance and audit activities for review and inspection by the Department. Audit records must be maintained for at least 6 years.
(6)Accreditation in Radiation Oncology.
(i)Each licensee must maintain accreditation in radiation oncology by the American College of Radiology, the American College of Radiation Oncology or other equivalent accrediting organization as determined by the Department.
(d)Unsealed byproduct material for which a written directive is required. A quality assurance program for unsealed byproduct material for which a written directive is required is a system of plans, actions, reviews, reports and records, the purpose of which is to ensure a consistent and safe fulfillment of the dose prescription.
