§ 175.41 Certified Registration for Therapeutic Radiation Machines.
RCNY § 175.41
(a)Certified registration required. All facilities with therapeutic radiation machines as defined in and subject to the requirements of this Article must maintain a certified registration for such therapeutic radiation machines from the Department in accordance with the provisions of this section.
(b)Certified registration application.
(1)An application for a certified registration must be made to the Department in a manner prescribed by the Department (2) If the application is for use sited in a medical institution, only a person serving as a principal officer or director on the institution's executive management may apply; for use not sited in a medical institution, a professional practitioner may apply.
(3)When a change affecting a radiation source or installation subject to the certified registration requirements of this section is considered by a registrant, including but not limited to changes ordered pursuant to this Article, so that the information on file with the Department will no longer be accurate, then the registrant must so inform the Department in writing: (i) for administrative changes, such as a change in business name, such notification must be made to the Department within 10 days of such change.
(ii)for all other changes, an amendment must be requested and received pursuant to this section.
(iii)failure to notify the Department of a change of ownership or address of a radiation installation may result in suspension or revocation of the installation's certified registration.
(4)At any time after the filing of an application for a certified registration, the Department may require the applicant to submit a supplementary information statement to enable the Department to determine whether such application should be approved or denied, or whether a previously issued registration should be amended, suspended or revoked.
(5)Each application or supplementary information statement must be signed by either the applicant personally or a person duly authorized by the applicant acting as its agent to sign on the applicant's behalf.
(6)The Department may approve an application for a certified registration if the Department determines that the following requirements have been met: (i) the applicant's proposed use, equipment, facilities and procedures can be reasonably expected to protect health and safety and minimize danger to life and property from radiation hazards; and (ii) the applicant's instrumentation is appropriate for detecting and measuring the type of radiation produced (either directly or indirectly) by the radiation source requested in the application; and (iii) the applicant or the applicant's personnel are qualified by licensure, training and experience to use such radiation source for the purposes covered by the application so as to protect health and safety and minimize danger to life and property from radiation hazards; and (iv) the applicant submits sufficient information to support a reasonable determination that the requirements of this Article will be met.
(7)Certified registrations issued by the Department pursuant to application shall be in the form of a written authorization permitting possession and use of radiation therapy machines. Such possession and use shall be subject to ongoing compliance with all applicable provisions of this Article and all conditions as stated on the certified registration.
(c)Certified registration; expiration, termination and amendment.
(2)The Department may terminate any certified registration upon the written request of the registrant.
