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(a) For each individual who is likely to receive, within 1 year, an occupational dose requiring monitoring pursuant to 24 RCNY Health Code § 175.17, the registrant must:
(1) determine the occupational radiation dose received during the current year; and
(2) request in writing the records of cumulative occupational radiation dose.
(b) In complying with the requirements of this section, a registrant may:
(1) accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; and
(2) accept, as the record of cumulative radiation dose, an up-to-date Department form or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the registrant; and
(3) obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the registrant, by telephone, telegram, facsimile, other electronic media or letter. The registrant must request a written verification of the dose data if the authenticity of the transmitted report cannot be established.
(c) The registrant must record the exposure history, with all the following required information:
(1) the form or record must show each period in which the individual received occupational exposure to radiation or radioactive material and must be signed by the individual who received the exposure. For each period for which the registrant obtains reports, the registrant must use the dose shown in the report. For any period in which the registrant does not obtain a report, the registrant must place a notation in the record or equivalent indicating the periods of time for which data are not available.
(2) for the purposes of complying with this requirement, registrants are not required to partition historical dose between external dose equivalent and internal committed dose equivalent. Occupational exposure histories that do not include effective dose equivalent may be used in the absence of specific information on the intake of radionuclides by the individual.
(d) If the registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the registrant shall assume:
(1) in establishing administrative controls for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and
(2) that the individual is not available for planned special exposures.
(e) The registrant must retain the records required by this section until the Department terminates each pertinent registration requiring this record. This includes records required under the standards for protection against radiation in effect prior to January 1, 1994.
(f) Upon termination of the registration, the registrant must permanently store such records, or must make provision with the Department for transfer of such records to the Department.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Recordkeeping. Each registrant must maintain records of doses received by all individuals for whom monitoring is required by this Article. These records must include, when applicable, the deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities.
(b) The registrant must make entries of the records of individual monitoring results at intervals not to exceed 1 year.
(c) The registrant must maintain individual monitoring results in clear and legible records containing all required information by the Department.
(d) The registrant must maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant worker. The declaration of pregnancy, including the estimated date of conception, must also be kept on file, but may be maintained separately from the dose records.
(e) The registrant must retain each required form or record until the Department terminates the certified registration or registration requiring the record.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Each registrant must maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public.
(b) The registrant must retain the records of dose to individual members of the public until the Department terminates each pertinent registration or certified registration requiring the record.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Each record required by this Article must be legible throughout the specified retention period and, where required, must be on the appropriate Department form. The record must be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period, or the record may also be stored in electronic media with the capability for producing legible, accurate and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials and signatures.
(b) The registrant must maintain adequate safeguards against tampering with and loss of records.
(c) The discontinuance or expiration of authorized activities does not relieve any person who possesses any radiation source of responsibility for retaining all records required by this Article.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Immediate notification. Notwithstanding other requirements for notification in this Article, each registrant must immediately report each unintended event involving a source of radiation possessed by the registrant that may have caused or threatens to cause any of the following conditions for an individual to receive:
(1) a total effective dose equivalent of 0.25 sievert (25 rem) or more; or
(2) a lens dose equivalent of 0.75 sievert (75 rem) or more; or
(3) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 sievert (250 rem) or more.
(b) Twenty-four hour notification. Each registrant must, within 24 hours of discovery, report to the Department:
(1) Any unintended event involving a registered source of radiation possessed by the registrant that may have caused, or threatens to cause, any of the following conditions for an individual to receive in a period of 24 hours:
(i) a total effective dose equivalent exceeding 0.05 sievert (5 rem); or
(ii) a lens dose equivalent exceeding 0.15 sievert (15 rem); or
(iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (50 rem).
(2) Any medical event as defined in 24 RCNY Health Code § 175.08.
(3) An event in which equipment is disabled or fails to function as intended when:
(i) the equipment is required by regulation or a condition of a registration to prevent exposures exceeding regulatory limits, or to mitigate the consequences of an accident; or
(ii) the equipment is required to be available and operable when it is disabled or fails to function; and
(iii) no redundant equipment is available and operable to perform the required safety function.
(c) Registrants must make the notification required by subdivisions (a) and (b) of this section by initial contact by telephone to the Department and must confirm the initial contact by letter, e-mail or facsimile to the Department. To the extent that the information is available at the time of notification, the information provided in these notifications must include:
(1) the caller's name and call back telephone number;
(2) a description of the event, including date and time;
(3) the exact location of the event;
(4) any personnel radiation exposure data available.
(d) Written reports. Each registrant must submit a written report to the Department within 30 days after learning of :
(1) events for which notification is required by 24 RCNY Health Code § 175.25(a) through (b);
(2) doses in excess of any of the following:
(i) the occupational dose limits for adults in 24 RCNY Health Code § 175.13;
(ii) the occupational dose limits for a minor in 24 RCNY Health Code § 175.13;
(iii) the limits for an embryo/fetus of a declared pregnant worker in 24 RCNY Health Code § 175.13;
(iv) the limits for an individual member of the public in 24 RCNY Health Code § 175.14; or
(v) any applicable limit in the registration;
(3) levels of radiation in:
(i) a restricted area in excess of applicable limits in the registration; or
(ii) an unrestricted area in excess of 10 times the applicable limit set forth in this Article or in the registration, whether or not involving exposure of any individual in excess of the limits in 24 RCNY Health Code § 175.13.
(e) Contents of written reports. Each report required by this section must include, as appropriate:
(1) a description of the event, including the probable cause of the elevated exposures or dose rates and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned
(2) estimates of each individual's dose;
(3) the levels of radiation involved; and
(4) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards and associated registration conditions.
(5) Each report filed pursuant to this section must include for each occupationally overexposed individual: the name, employee ID number if available, and date of birth. With respect to the limit for the embryo/fetus in 24 RCNY Health Code § 175.13, the identifiers should be those of the declared pregnant worker. The report must be prepared so that individually-identifiable information is stated in a separate and detachable portion of the report and not otherwise revealed.
(f) Any written report of a medical event as defined in 24 RCNY Health Code § 175.08 must include a calculation of the resulting radiation dose that was delivered in error, and be forwarded to the registrant's radiation safety committee or the radiation safety officer for their action. The report must be maintained on-site, or readily available for review by the Department during inspection.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) When a registrant is required to report to the Department any exposure of an identified occupationally-exposed individual, or an identified member of the public to radiation, the registrant must also provide a copy of the report submitted to the Department to the individual. This report must be transmitted at a time no later than the transmittal to the Department.
(b) When necessary or desirable in order to aid in determining the extent of any individual's exposure to radiation subsequent to any radiation accident, or incident, the registrant must make available to such individual appropriate medical evaluation services or appropriate tests and furnish the Department a copy of each report of such evaluation or test.
(Added City Record 4/24/2019, eff. 5/24/2019)
(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)
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