Title: Section 16.24 - Quality assurance programs for the use of radiation for therapy in humans
16.24 Quality Assurance Programs for the Use of Radiation for Therapy in Humans.
(a) External beam therapy and brachytherapy. Each licensee or registrant authorized to administer external beam therapy or brachytherapy to human beings shall implement a quality assurance program to systematically monitor, evaluate and document radiation therapy services to ensure consistent and safe fulfillment of the dose prescription to the target volume, with minimal dose to normal tissues, minimal exposure to personnel and adequate patient monitoring aimed at determining the end result of the treatment. Each such licensee or registrant shall meet or exceed all quality assurance criteria described in this subdivision.
(1) Each licensee or registrant shall adopt and maintain a quality assurance manual that includes policies and procedures that require the following:
(i) Each patient's medical record shall be complete, accurate, legible and shall include the patient's initial clinical evaluation, treatment planning data, treatment execution data, clinical assessments during treatment, a treatment summary and plan for subsequent care. Treatment related data shall be recorded in the patient's medical record at the time of each treatment.
(ii) A written and dated order or prescription for the medical use of radiation or radioactive material shall be made for each patient in accordance with subdivisions (b) and (c) of section 16.19 of this Part. The order or prescription shall be signed or approved electronically by a board certified radiation oncologist or qualified physician who restricts his or her 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 shall be verified by qualified clinical staff prior to patient treatment.
(iv) A radiation therapy technologist, physician or other qualified health practitioner shall 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 shall 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 shall be verified by at least two different means by qualified clinical staff prior to each treatment.
(vii) Each patient's response to treatment shall be assessed by a board certified radiation oncologist or other qualified physician in the active practice of external beam therapy and/or brachytherapy. Unusual responses shall 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 shall be checked for completeness and accuracy by qualified clinical staff at intervals not to exceed six fractions.
(ix) Radiation treatment plans and related calculations shall 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 shall 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 paragraph (1) of subdivision (d) of section 16.123 of this Part, 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 registrant's or licensee's treatment planning procedures manual required pursuant to subparagraph (2) of this paragraph, and who has received training in use of the manual pursuant to subparagraph (2) of this paragraph.
(x) All equipment and other technology used in planning and administering radiation therapy shall function properly and safely, and shall 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, shall 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 shall 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(s) conducting the test and for the person who reviews test data.
(xii) Test results that exceed tolerances/limits shall be immediately reported to the authorized medical physicist.
(xiii) Records for all maintenance, repairs and upgrades of equipment and technology shall be maintained for at least five years.
(xiv) Errors or defects in technology or equipment, including computer hardware and software, shall 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 clause shall be maintained for review by the Department for at least three years.
(xv) External beam therapy equipment calibration/output required by section16.60(c)(1) of this Part shall be verified by an independent means and records of such measurements shall be retained for review by the Department for at least three years.
(xvi) Patients with permanent brachytherapy implants shall be provided with instructions to take radiation safety precautions, as required by section 16.123(e)(4) (incorporating 10 CFR 35.75) and the licensee's radioactive materials license, after being released from the licensee’s facility.
(xvii) All personnel involved in planning or implementing radiation therapy shall be credentialed. Credentialing shall include verifying that all professional staff are appropriately licensed, including medical physicists and radiation therapy technologists. Records of credentialing shall be maintained during the period in which the credentialed person provides services to the licensee or registrant and for three years thereafter.
(xviii) Any unintended deviation from the treatment plan that is identified shall be evaluated and corrective action to prevent recurrence shall be implemented. Records of unintended deviations and corrective action shall be maintained for audits required by paragraph (4) of this subdivision and for review by the Department.
(xix) There shall be a process to ensure quick and effective response to any radiation therapy related recalls, notices, safety alerts and hazards.
(2) Each licensee or registrant shall adopt and maintain a radiation treatment manual that includes 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 in paragraph (1) of this subdivision). The treatment planning manual may be part of the quality assurance manual required by paragraph (1) of this subdivision. The radiation treatment manual shall be included in training given pursuant to subdivision (c) of section 16.13 of this Part to facility staff who will participate in treatment planning. Each licensee or registrant shall ensure that an authorized medical physicist possessing the qualifications specified in paragraph (1) of subdivision (d) of section 16.123 of this Part prepares or reviews and approves a procedures manual describing how radiation therapy treatment planning is to be performed at the licensee’s or registrant's facility and reviews the treatment planning manual at least annually.
(3) Each licensee or registrant shall 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 or registrant's quality assurance manual.
(4) Each licensee or registrant shall implement written procedures for auditing the effectiveness of the radiation therapy quality assurance program that include the following:
(i) Audits shall be conducted at intervals not to exceed 12 months by an authorized medical physicist possessing the qualifications specified in paragraph (1) of subdivision (d) of section 16.123 of this Part, and also by a physician, both of whom are in the active practice of the type of radiation therapy conducted by the licensee or registrant.
(ii) The licensee or registrant shall ensure that the individuals who conduct the audit prepare and deliver to the licensee or registrant a report which contains an assessment of the effectiveness of the quality assurance program and makes recommendations for any needed modifications or improvements.
(iii) The licensee or registrant shall promptly review the audit findings, address the need for modifications or improvements, and document actions taken. If recommendations are not acted on, the licensee or registrant shall document the reasons therefor and also alternative actions taken to address the audit findings.
(iv) Each licensee or registrant shall maintain for review and inspection by the Department complete written records relating to quality assurance and audit activities. Audit records shall be maintained for at least 6 years.
(6) Accreditation in Radiation Oncology.
(i) Effective 90 days from the effective date of this regulation, each registrant or licensee shall have an active application with, or be accredited in radiation oncology by, the American College of Radiology, the American College of Radiation Oncology or another accrediting organization that is equivalent as determined by the Department.
(ii) Effective 18 months from the effective date of this regulation, each registrant and licensee shall maintain accreditation in radiation oncology by the American College of Radiology, the American College of Radiation Oncology or another accrediting organization that is equivalent as determined by the Department.
(iii) The registrant or licensee shall 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 shall be maintained for at least 6 years.
VOLUME A (Title 10)