§ 175.40 Registration of Radiation Machine Facilities.
RCNY § 175.40
(a)Registration required. Prior to establishing, maintaining or operating any radiation installation with any radiation equipment in operable condition, or prior to installing such equipment which is intended to be used, the owner, operator or person in charge of such installation must have obtained a current certificate of registration or, for a therapeutic radiation machine as defined in and subject to the requirements of this Article, a certified registration from the Department. Unless otherwise authorized by the Department, no one shall apply x-rays to diagnose or treat any patient's medical condition at a facility that does not possess a current, non- expired certificate of registration issued from the Department. This subdivision does not prohibit the installation of radiation-producing equipment at a facility solely for testing purposes by a QMP, or for testing necessary to prepare reports required for registration.
(b)Application for a certificate of registration must be made to the Department in a manner prescribed by the Department.
(c)Registered facilities at which the owner, operator or location will be changed must apply for a new registration prior to such change.
(d)The applicant for registration for all facilities mandated to have a quality assurance program pursuant to 24 RCNY Health Code § 175.12(b) must: (1) submit a completed application form and required supporting documents, if any; and, (2) submit a report prepared by a QMP detailing the results of initial quality assurance tests conducted on all radiation-producing equipment in the facility. In this context, the initial quality assurance tests shall be the sum of all quality assurance tests mandated to be conducted for the facility type at any frequency (for example all daily, monthly, and annually required tests etc.). Also, a radiation protection survey must be conducted and submitted for each room housing a radiographic unit.
(3)designate a radiation safety officer on each application form.
(4)designate a professional practitioner responsible for directing the operation of radiation machines on each healing arts application. The signature of the administrator, president or chief executive officer will be accepted in lieu of a professional practitioner's signature if the facility has more than one professional practitioner (for example, hospitals, large clinics, or multi-practitioner practices).
(e)An application for registration may be denied for any basis provided in this Article.
(f)The Department will not grant a facility's registration until such time as the report described in 24 RCNY Health Code § 175.40(d)(2) contains all mandated quality assurance tests and all corrective actions that may be required therefrom have been completed as determined by the Department.
(1)Upon completion of the review process for the submitted quality assurance tests by the facility, if reasons exist to refuse authorization to register the facility's radiation- producing equipment for clinical usage, the facility shall be notified of the reasons for such a decision by the Department in writing and shall be provided an opportunity to respond.
(2)If requested, the applicant must file all responsive information that the Department finds deficient within 30 days of the Department's request, or the application will be deemed abandoned and void. In the latter case, the applicant must refile the application.
(g)Dental, podiatric and veterinary facilities.
(h)Renewal registrations. Facilities with current, valid certificates of registration must apply for renewal at least 30 days prior to the expiration of such certificate of registration. Facilities with a certificate of registration that is suspended or revoked, or where the installation is discontinued on or before the expiration of the certificate of registration, may not apply for renewal.
(i)Fees. Fees for each registration and certified registration shall be paid pursuant to 24 RCNY Health Code §§ 5.07 and 5.09(f).
(j)Duration of registrations. A certificate of registration shall be issued for a limited period of time extending from the date of issuance to the date of expiration as specified on the certificate of registration. Registration validity shall not exceed 2 years except that the Department, at its discretion, may issue a certificate of registration for a longer period of time in order to stagger expiration dates for administrative purposes and may charge a proportionate increase in fees to reflect this.
(k)Expiration of registrations.
(l)Suspension and revocation of registrations. A registration may be suspended or revoked for any basis provided in this Article, including pursuant to 24 RCNY Health Code § 5.17, or if the Commissioner finds that: (1) the information submitted in the application is materially incorrect or incomplete; (2) the installation is, has been or will be established, maintained, or operated in violation of this Article, or any other applicable law, rule, regulation, order or condition; (3) the certificate of registration has not been issued correctly; or (4) the fees for registration or inspections and adjudicated fines have not been paid as required.
(m)A certificate of registration issued for a radiation installation must be posted in accordance with the provisions of 24 RCNY Health Code § 5.15. If posting is not practicable, the registrant may post a notice stating where it may be examined.
(n)The operator of a radiation installation must keep its registration information current by reporting to the Department of any change affecting the registration within 10 days of such change.
(o)The registration issued to a facility does not imply endorsement or approval by the Department and must not be used to advertise or promote business.
(p)A certificate of registration or certified registration is not transferable or assignable.
(q)The Department may refuse to issue, or may suspend or revoke, a certificate of registration for any facility that refuses to allow the Department to conduct an inspection of all of the facility's x-ray equipment or records or refuses or is unable to correct any violations of this Article noted during an inspection.
(r)Exemptions. Registration with the Department is not required for: (1) radiation equipment constructed so that it cannot emit radiation at a level greater than 0.5 milliroentgen per hour, measured 5 cm (2 in.) from any accessible surface thereof, and averaged over an area of 10 cm 2 (1.55 in 2 ) provided, however, that such exemption shall not apply to the testing or servicing of such equipment during its production; or (2) radiation equipment during its storage, shipment, retail sale or other similar use (but not including installation) during which such equipment is not connected to a voltage source and does not emit radiation, provided however, that such equipment is not exempt from the labeling requirement of 24 RCNY Health Code § 175.20. (Added City Record 4/24/2019, eff. 5/24/2019)
