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(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.
(1) All new dental, podiatric, and veterinary facilities without a current certificate of registration must apply for a new registration prior to the beginning of facility operation. All new dental, podiatric and veterinary facilities shall be prohibited from commencing diagnostic clinical examinations until such time that the facility has either received a certificate of registration from the Department for all such equipment, or the Department has performed a physical inspection of the facility and any deficiencies identified have been corrected, or the Department has reviewed and approved the QMP or CRESO reports to determine that all radiological equipment to be used are operating as intended.
(2) A dental facility possessing a Cone Beam Computed Tomography (CBCT) unit must maintain a quality assurance program for such CBCT unit and shall register such CBCT unit with the Department in accordance with subdivision (d) of this section prior to conducting clinical exams with such CBCT unit.
(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.
(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.
(1) The registration issued for a radiation installation shall expire and may be required to be surrendered to the Department upon:
(i) failure to renew by the expiration date specified on the certificate of registration; or
(ii) revocation by the Commissioner; or
(iii) a change of the person to whom the certificate of registration is issued; or
(iv) a change in address of the radiation installation if it is not a mobile unit; or
(v) a change in the name of the installation; or
(vi) the discontinuance of the installation.
(2) Notwithstanding paragraph (1) of this subdivision, if a registrant whose registration has expired indicates in writing to the Department that they are in the process of completing and files a proper registration application renewal form with the Department, or properly files for a new and superseding registration, at least 30 days prior to the stated expiration date, such registration shall not be deemed to have expired until the Department has decided upon such renewal application.
(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)
(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.
(1) Except as otherwise provided in this Article, or authorized by the Department, each certified registration shall expire on the expiration date stated on the certified registration. If any current certified registrant duly files with the Department an application in proper form for renewal of such certified registration, or for a new and superseding certified registration, not less than 30 days prior to the stated expiration date, such certified registration shall not be deemed to have expired until the Department has decided such renewal application.
(2) The Department may terminate any certified registration upon the written request of the registrant.
(3) The Department may at any time set forth in any certified registration or incorporate by reference therein, additional conditions, restrictions or requirements applicable to the registrant's transfer, receipt, possession or use of any radiation source covered by such certified registration in order to protect the public health and safety and to minimize danger to life and property from radiation hazards.
(4) Any certified registration may be amended or revoked by the Department by reason of amendment of this Article, or any other applicable law or regulation.
(5) Any certified registration may be suspended or revoked by the Department for any basis provided in this Article, including but not limited to, the following:
(i) any material misstatement in the application or in any supplementary statement thereto;
(ii) any condition revealed by such application, supplementary statement, report, record, inspection, investigation or other means, which would warrant the Department's refusal to grant a certified registration on an original application; or
(iii) any violation or failure to observe any condition of such certified registration, this Article, or any other applicable law, rule, regulation or order now or hereafter in effect.
(6) A registrant must apply for, and must have received approval for, a certified registration amendment before:
(i) permitting anyone not listed on the registrant's certified registration to work as an authorized user under the certified registration;
(ii) permanently changing the radiation safety officer;
(iii) making any change in the treatment room shielding;
(iv) making any change in the location of the therapeutic radiation machine within the treatment room;
(v) using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the treatment room;
(vi) relocating the therapeutic radiation machine;
(vii) allowing an individual not listed on the registrant's certified registration to perform the duties of the QMP, except during the temporary absence of the QMP when a person who is otherwise qualified to perform such duties may perform such duties; such temporary absence must not exceed 60 days; or
(viii) changing non-administrative statements, representations or procedures incorporated by reference into the certified registration.
(7) Any application by a registrant for an amendment of a certified registration must be filed in writing with the Department and must set forth in detail the reasons for such requested amendment.
(Added City Record 4/24/2019, eff. 5/24/2019)
For purposes of this section, mobile service operations means an x-ray unit of any type that is used in a van or similar vehicle to conduct x-ray examinations outside a fixed location. In addition to the requirements of 24 RCNY Health Code § 175.40, the applicant must provide the following information:
(a) an established main location where the machines, records, etc. will be maintained for inspection. This must be a street address, not a post office box number.
(b) a sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location; and
(c) a current copy of the applicant's operating and safety procedures, including radiological practices for protection of patients, operators, employees and the general public.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Any person who sells, leases, transfers, lends, disposes, assembles or installs radiation machines in New York City must notify the Department within 15 days of:
(1) the name and address of persons who have received these machines;
(2) the manufacturer, model, and serial number of each radiation machine transferred; and
(3) the date of transfer of each radiation machine.
(b) No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation meet the requirements of this Article and any other applicable law.
(c) The submission to the Department of FDA Form 2579 (Report of Assembly of a Diagnostic X-ray System) shall be deemed to meet all the requirements of this section.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) All surveys, audits, reports, or other work ("technical report") performed by a QMP or CRESO as required by this Article must be reviewed and signed by such QMP or CRESO.
(b) If the Department determines that any technical report of any QMP or CRESO providing services required by this Article are inadequate to assess radiation exposures, the Department may require such technical report to be revised or re-done according to specifications provided by the Department, or if this is not satisfactory, the Department may require the registrant or licensee to have such technical report performed by another QMP or CRESO. If the Department makes such a determination, it shall notify such QMP or CRESO of such determination and allow such QMP or CRESO an opportunity to be heard before the Department prior to any notification by the Department of its determinations, if any, to such individual's appropriate certifying agency.
(Added City Record 4/24/2019, eff. 5/24/2019)
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