New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter I - State Sanitary Code › Part 16 - Ionizing Radiation › General Provisions › Section 16.24 - Quality assurance programs for the use of radiation for therapy in humans

Current through Register Vol. 46, No. 28, July 10, 2024
(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 section
				  16.19(b)
				  and (c)  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 section
				  16.123(d)(1) 
				  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 paragraph (2) of this subdivision, and
				  who has received training in use of the manual pursuant to paragraph (2) of
				  this subdivision.
(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) recordkeeping 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) 
				  of this Part (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.