Radiation Control (Article 175) - Quality Assurance
Proposed Rules: Closed to Comments
Statement of Basis and Purpose of Proposed Rule
This amendment to the New York City Health Code (“Health Code”) is proposed pursuant to Sections 556, 558 and 1043 of the New York City Charter (“Charter”). Section 556 of the Charter grants the New York City Department of Health and Mental Hygiene (“Department”) jurisdiction to regulate all matters affecting health in the City of New York. Specifically, Section 556 (c)(11) of the Charter authorizes the Department to regulate all aspects of ionizing radiation within the five boroughs of New York City. Sections 558 (b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the Health Code all matters to which the Department’s authority extends. Section 1043 of the Charter grants rule-making powers to the Department.
Section 228 of the New York State Public Health Law provides that local enactments like section 175.07 of the Health Code must be consistent with the requirements of the New York State Sanitary Code, as codified at Chapter I of Title 10 of the Codes, Regulations and Rules of New York State. In order to be consistent with recent State Sanitary Code amendments involving updated quality assurance requirements for external beam and brachytherapy radiation treatment, the Department is proposing commensurate changes to the corresponding requirements in the Health Code.
The Department, through its Office of Radiological Health (“ORH”), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.
ORH regulations for radiation machines and radioactive materials are contained in Article 175 of the Health Code. ORH registers and inspects radiation machines, and licenses and inspects radioactive materials facilities for compliance with Article 175 for the protection of the health and safety of patients, radiation program employees and the general public.
There are about 6500 registered facilities possessing radiation machines and 375 licensed sites in New York City possessing radioactive material for medical, academic and research purposes. Of the registered facilities, approximately 6440 are registered diagnostic X-ray facilities and 60 are therapeutic X-ray facilities possessing certified registrations.
The State Sanitary Code was recently amended to reflect updated quality assurance requirements for external beam and brachytherapy radiation treatment (see, 10 NYCRR §16.24(a)). In order to maintain consistency, the Department is proposing to make commensurate changes to its corresponding requirements in §175.07(c) of Article 175 of the Health Code.
Proposed Rule Elements and Goals
The Department proposes that the Board of Health repeal current subdivision (c) of §175.07 and replace it with a new subdivision (c) that includes updated quality assurance standards for radiation materials licensees or radiation equipment registrants who are authorized to administer external beam therapy or brachytherapy to humans. The new subdivision includes quality standards appropriate for newer, more complex radiation therapy treatment systems and also requires additional verification of radiation set-up equipment and treatment plans prior to administering radiation treatments to patients. New subdivision (c) also requires quality assurance programs to cover data communication/transfer between component systems of planning and treatment delivery systems to ensure complete, uncorrupted data transfer. Additionally, the new subdivision requires licensees and registrants to credential individuals involved in quality assurance testing, treatment planning, and radiation treatment of patients. Finally, new subdivision (c) requires licensees and registrants to be accredited in radiation oncology by the American College of Radiology or the American College of Radiation Oncology, or another equivalent accrediting organization, within 18 months of the effective date of the rule.
The New York City Board of Health’s authority for these rules is found in sections 556, 558 and 1043 of the City Charter. This proposed rule implements particular standards set forth in newly enacted state regulations with only minor exercise of the Board’s discretion. Pursuant to section 1043(d)(4)(iii), the analysis required by Section 1043(d) of the Charter was not performed.