Effective Date: 12/30/92
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. A quality assurance program for external beam therapy and brachytherapy is a system of plans, actions, reviews, reports and records whose purpose is to ensure a consistent and safe fulfillment of the dose prescription to the target volume, with minimal dose to normal tissues.

(1) Beginning March 31, 1993 each licensee or registrant who uses external beam therapy and/or brachytherapy in humans shall implement a quality assurance program which includes at a minimum:

(i) the adoption of a quality assurance manual containing written policies and procedures designed to assure effective supervision, safety, proper performance of equipment, effective communication and quality control. These must include policies and procedures to assure that:

(a) each patient's evaluation and intended treatment is documented in the patient's record;

(b) a written, signed and dated order for medical use of radiation or radioactive material is made for each patient in accordance with subdivision (b) and subdivision (c) of section 16.19 of this Part;

(c) all orders and other treatment records are clear and legible;

(d) staff will be instructed to obtain clarification before treating a patient if any element of the order or other record is confusing, ambiguous or suspected of being erroneous;

(e) each patient's response to treatment is assessed by a physician knowledgeable in external beam therapy and/or brachytherapy and that unusual responses are evaluated as possible indications of treatment errors;

(f) complete treatment records containing data recorded at the time of each treatment are maintained;

(g) the treatment charts of patients undergoing fractionated treatment are checked for completeness and accuracy at weekly intervals;

(h) final plans of treatment and related calculations are checked for accuracy before 25% of the prescribed dose for external beam therapy or 50% of the prescribed dose for brachytherapy is administered. If a treatment plan and related calculations were originally prepared by a radiation therapy physicist possessing the qualifications specified in subdivision (f) of section 16.122 it may be checked by the same person using a different calculational method. Treatment plans and related calculations prepared by other personnel must be checked by a second person using procedures specified in the 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.

(i) there is quality control for all physical components of radiation therapy such as: equipment function and safety (including treatment planning equipment), treatment planning procedures and computer codes, treatment application procedures, dosimetry, and personnel radiation safety;

(j) that the quality control tests to be performed are documented, including:

(1) detailed procedures for performing each test;

(2) the frequency of each test;

(3) acceptable results for each test;

(4) corrective actions to be taken; and

(5) record keeping and reporting procedures for test results.

(2) Each licensee or registrant shall ensure that a radiation therapy physicist possessing the qualifications specified in subdivision (f) of section 16.122 of this Part prepares a procedures manual describing how radiation therapy treatment planning is to be performed at the licensee's or registrant's facility. The treatment planning manual may be part of the quality assurance manual required by paragraph (1) of this subdivision and shall 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 in paragraph (1) of this subdivision). The treatment planning manual shall be reviewed annually by a radiation therapy physicist and shall be included in training given pursuant to subdivision (c) of section 16.13 to facility staff who will participate in treatment planning.

(3) Each licensee or registrant shall ensure that all equipment used in planning and administering radiation therapy is properly functioning and designed for the intended purpose; is properly calibrated; and is 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 procedures for auditing the effectiveness of the radiation therapy quality assurance program as specified below. Audit procedures must specify either that: (i) external audits will be conducted at intervals not to exceed 12 months by radiation therapy physicists possessing the qualifications specified in subdivision (f) of section 16.122, and physicians who are in the active practice of the type of radiation therapy conducted by the licensee or registrant. These must be individuals who are not involved in the conduct of the therapy program being audited; and

(a) the individuals who conduct the audit will 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; and

(b) 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 reasons for this will also be documented; or

(ii) internal audits will be conducted at intervals not to exceed 12 months by program staff who will prepare and deliver to the licensee or registrant a report as specified in clause (a) of subparagraph (i) of this paragraph, and external audits will be conducted at intervals not to exceed five years by an organized review program supervised by the American College of Radiology, or a program found equivalent by the department based on the scope of the audit and the experience of the sponsoring organization in performing such audits; and

(a) 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 reasons for this will also be documented.

(5) Each licensee or registrant must maintain written records for review by the department which document quality assurance and audit activities.

(b) Radiopharmaceutical therapy. A quality assurance program for radiopharmaceutical therapy is a system of plans, actions, reviews, reports and records whose purpose is to ensure a consistent and safe fulfillment of the dose prescription.

(1) Beginning March 31, 1993, each licensee who uses radiopharmaceuticals for therapy in humans shall implement a quality assurance program which includes at a minimum:

(i) the adoption of a manual containing written policies and procedures designed to assure effective supervision, safety, proper performance of equipment, effective communication and quality control. These must include procedures to assure that:

(a) each patient's evaluation and intended treatment is documented in the patient's record;

(b) a written, signed and dated order for medical use of radioactive material is made in accordance with subdivision (c) of section 16.19 of this Part;

(c) all orders and other treatment records are clear and legible;

(d) staff will be instructed to obtain clarification before treating a patient if any element of the order or other record is confusing, ambiguous or suspected of being erroneous;

(e) each patient's response to treatment is assessed by a physician knowledgeable in radiopharmaceutical therapy and that unusual responses are evaluated as possible indications of treatment errors; and

(f) complete treatment records containing data recorded at the time of each treatment are maintained.


(2) Each licensee shall ensure that all equipment used in planning and administering radiopharmaceutical therapy is designed for the intended purpose and is properly functioning; is properly calibrated and is maintained in accordance with the manufacturer's instructions and the quality assurance program described in the licensee or registrant's quality assurance manual.

(3) Each licensee shall: audit the radiopharmaceutical quality assurance program at intervals not to exceed 12 months to assess the effectiveness of the program; document the audit and any modifications or improvements found to be needed; and institute corrective actions and improvements as indicated by the audit findings.




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