10-144-220 Me. Code R. § F-3

Current through 2024-51, December 18, 2024

Section 144-220-F-3 - General requirements

A. Administrative Controls.

(1) Registrant. The registrant shall be responsible for directing the operation of the x-ray system(s) under his administrative control. The registrant or the registrant's agent shall assure that the requirements of F.3.A.(1) are met in the operation of the x-ray system(s).

(a) Any x-ray system (whether certified or non-certified) which does not meet the provisions of this rule shall not be operated for diagnostic or therapeutic purposes unless a written exception is received from the Agency. See Section F.3.D.

(b) Individuals who will be operating the x-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. The licensing requirements pursuant to 32 MRSA Chapters 103 § 9851 et seq and 331 § 1100 I et seq as well as the associated rules established by the Radiologic Technology Board of Examiners and the Board of Dental Examiners shall be followed.

(c) Except for intraoral and extraoral dental radiography, a chart shall be provided in the vicinity of the diagnostic x-ray system's control panel. If the posting in the vicinity of the control panel is not practical, it shall be conspicuously available to users of the equipment. The following information shall be specified on the chart:

(i) patient's anatomical size versus technique factors to be utilized,

(ii) type and size of the film or film-screen combination to be used,

(iii) type and focal distance of the grid to be used, if any,

(iv) source to image receptor distance to be used; and

(d) Written safety procedures and rules shall be posted in the vicinity of each x-ray control panel, including any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures. Copies of certificates of those individuals duly authorized to perform such x-rays shall be conspicuously posted.

(e) Except for human patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:

(i) All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material.

(ii) The x-ray operator, other staff, ancillary personnel and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent.

(iii) Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or shall be so positioned that the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.

(f) Gonad shielding of not less than 0.5 millimeter lead equivalent material shall be used for human patients who have not passed the reproductive age during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

(g) Individuals shall not be exposed to the useful beam except for healing arts purposes and such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

(i) Exposure of an individual for training, demonstration or other non-healing-arts purposes; and

(ii) Exposure of an individual for the purpose of healing arts screening except as authorized by F.3.A.(1)(k).

(h) When a patient or film must be provided with auxiliary support during a radiation exposure:

(i) Mechanical holding devices shall be used when the technique permits;

(ii) Written safety procedures, as required by F.3.A.(1)(d), shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

(iii) The human holder shall be instructed in personal radiation safety and be protected as required by paragraph F.3.A.(1)(e).

(iv) No individual shall be used routinely to hold film or patients; and

(v) In those cases where the patient must hold the film, except during intraoral or extraoral dental examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material; and

(vi) Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved with x-ray operations and who are otherwise not shielded.

(i) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.

(i) The screen and film combinations used shall be the fastest speed consistent with the diagnostic objective of the examinations. Cassettes without intensifying screens shall not be used for any diagnostic radiological imaging, with the exception of standard film packets for intra-oral use in dental radiography.

(ii) Portable or mobile equipment shall only be used in cases where it is impractical to transfer the patient(s) to a stationary x-ray unit. Portable equipment is not to be used as a substitute for a stationary unit.

(iii) Film processing is to be conducted in accordance with the manufacturer's instructions.

(j) All individuals who are associated with the operation of an x-ray system are subject to the requirements of D.1201, D.2104 and D.1502 of this rule. In addition:

(i) When protective clothing or devices are worn on portions of the body and a monitoring device(s) is required, at least one such monitoring device shall be utilized as follows:

(ii) When an apron is worn, the monitoring device shall be worn at the collar outside of the apron.

(iii) The dose to the whole body based on the maximum dose attributed to the most critical organ shall be recorded in the reports required by D.2106 of this rule. If more than one device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body.

(iv) Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.

(k) Healing arts screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Agency. When requesting such approval, that person shall submit the information outlined in Appendix C of this part. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified.

(2) Information and maintenance record and associated information. The registrant shall maintain the following information for each x-ray system or, as appropriate, facility, for inspection by the Agency:

(a) Model and serial numbers of all certifiable components, if readily available;

(b) Aluminum equivalent filtration of the useful beam, including any routine variation;

(c) Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system(s) after the effective date of this rule with the names of persons who performed such services;

(d) For all facilities constructed or modified after January 1, 1986, a scale drawing of the room in which a stationary x-ray system is located with such drawing indicating the use of areas adjacent to the room, an estimation of the extent of occupancy by an individual in such areas, and the location of the x-ray machine. In addition, the drawing shall include:

(i) The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions, or

(ii) The type and thickness of materials, or lead equivalency, of each protective barrier; and

(e) A copy of all correspondence with this Agency regarding that x-ray system.

(f) A copy of the facility's x-ray quality assurance program. (See Section F.5.I.)

(3) X-ray patient record.Each facility shall have available for inspection a record (either paper or electronic) or other such document identifying the patient by number or name, the type of examination, the date, the room where the examination was performed, and who performed the x-ray.

B. Shielding requirements and plan review.

(1) Prior to initial operation, the floor plans and equipment arrangement of all new installations, or modifications of existing installations, utilizing x-rays for diagnostic or therapeutic purposes shall be submitted to the Agency. The required information is denoted in Appendices A and B of this part.

(2) The applicant shall utilize the services of a Radiological Physicist to determine the shielding requirements prior to plan review and approval by the Department. In determining the shielding requirements for dental x-ray facilities, the Department may authorize other professionals, providing their qualifications justify such an authorization.

(3) The submittal of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in D.1201, D.1207 and D.1301 of this rule.

C. Initial and Periodic Survey.

(1) Pursuant to 22 MRS §682, duly authorized employees of the Department may enter into establishments during working hours to determine whether there is compliance with provisions of the Radiation Protection Act.

(2) Departmental Certification of Technicians, as authorized by 22 MRS § 682(3), designated as qualified experts, and authorized by the Department shall be utilized to perform inspection and calibration services, and to certify x-ray and/or teletherapy units (see section G.632).

(3) Existing facilities: Except as stated in section F.3.C.45, the licensee of all existing x-ray facilities shall have each x-ray machine and tube inspected at the following minimum frequency:

(a) Hospitals - prior to January 1, 1987 and once every year thereafter;

(b) Mammographic Facilities - prior to January 1, 1991, and every year thereafter;

(c) Dental Facilities - prior to January 1, 1988 and once every three years thereafter;

(d) Podiatric - prior to January 1, 1987 and once every three years thereafter;

(e) Veterinary - prior to January 1, 1987 and once every five years thereafter;

(f) All Others - prior to January 1, 1987 and once every two years thereafter.

(4) The periodic quality control survey, conducted at the above stated frequencies, is not covered by the annual registration fee but is in addition to that fee. When the inspections are carried out by third-party, non-state technicians, the fee is determined by the inspector and the facility.

(5) Except for intra-oral, panorex, mammographic and podiatric x-ray machines, all new facilities and existing facilities adding new machines shall have a survey made by a qualified expert within 30 days. The intra-oral, panorex and podiatric machines shall be inspected within 12 months. Mammographic facilities shall be inspected by a qualified expert prior to operation. In addition, such surveys shall also be done after any change in the facility or equipment which might cause a significant increase in radiation hazard. See F.4.

(6) The registrant shall obtain a written report of the survey from the Qualified Expert and a copy of the report shall be transmitted by the registrant to the Agency within 30 days of receipt of the report.

(7) Upon notification or discovery of a violation to the Rules stated in this section, the Department may, in its notice of violation to the licensee, require a re-inspection by a qualified expert. This increase in frequency of inspection will depend upon the severity of the violation.

D. Exemptions.

(1) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of Part F, providing the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 5 microSievert (0.5 mrem) per hour at 5 cm from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

(2) Radiation machines while in transit or storage incident thereto are exempt from the requirements of Part F.

(3) Domestic television receivers are exempt from the requirements of this part.

(4) Exemptions to the requirements of Part F may be granted, provided written justification is submitted by a qualified expert.

E. Applications for registration of radiation machine facilities.

(1) Each person having a radiation machine facility shall apply for registration of such facility with the Agency following the effective date of this rule or thereafter prior to the operation of a radiation machine facility. Application for registration shall be completed on form HHE 805 X-Ray Registration Form furnished by the Agency and shall contain all the information required by the form and accompanying instructions. At a minimum, the form shall include the following information.

(a) Name, address, and telephone number of the following:

(i) The radiation machine facility.

(ii) The owner of the radiation machine facility.

(iii) The individual responsible for the use of the facility.

(iv) The individual responsible for radiation protection at the facility.

(b) The manufacturer, model number, and type of each radiation machine located within the facility.

(c) The signature of the individual designated as the qualified expert.

(d) Name of the radiation machine supplier, installer, and service agent.

(e) The date of application and signature of the individual responsible for the use of the facility.

(2) Registration Fee.

(a) A registration fee for each x-ray tube shall be paid annually. Appendix F to this Part provides the schedule of fees.

(b) Submit a check payable to the Treasurer State of Maine, along with the application for annual registration for the appropriate amount specified.

(3) The licensee of all x-ray facilities shall have each x-ray machine and tube inspected in accordance with the requirements of Section F.3.C.

F. Application for Registration of Servicing and Services

(1) Each person who is engaged in the business of installing or offering to install radiation machines or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State shall apply for registration of such services with the Agency within 30 days following the effective date of this regulation or thereafter prior to furnishing or offering to furnish any such services.

(2) Application for registration shall be completed on form HHE 825 Registration of Servicing and/or Services Employee Exposure Form furnished by the Agency and shall contain all information required by the Agency as indicated on the forms and accompanying instructions. No fee is required.

(3) Certification and registration of qualified experts for the conducting of the periodic survey is covered in Part F.4.

(4) The service representative shall notify the agency in writing of any address, telephone or personnel changes.

G. Issuance of notice of registration.

(1) Upon a determination that the requirements of Part F.3.E have been met, the Agency shall issue a notice of registration.

(2) The Agency may incorporate in the notice of registration at the time of issuance or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use and transfer of radiation machines as it deems appropriate or necessary.

H. Expiration of notice of registration. Except as provided by F.3.I each notice of registration shall expire at the end of the specified day in the month and year stated therein, or upon notice issued to the registrant by the Agency.

I. Renewal of notice of registration.

(1) Application for renewal of registration shall be filed annually and in accordance with Part F.3.E.(2). Application for renewal of registration and notification of current expiration date will be provided to each licensee by the Agency at least 60 days prior to the expiration date.

(2) In any case in which a registrant not fewer than 30 days prior to the expiration of his or her existing notice of registration has filed an application in proper form for renewal, such existing notice of registration shall not expire until the application status has been finally determined by the Agency.

J. Report of changes. The registrant shall notify the Agency in writing before making any changes which would render the information contained in the application for registration and/or the notice of registration no longer accurate.

K. Approval not implied. No person, in any advertisement, shall refer to the fact that his or her facility is registered with the Agency pursuan t to these provisions, and no person shall state or imply that any activity under such registration has been approved by the Agency.

L. Assembler and/or transfer obligation.

(1) Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines in this State shall notify the Agency within 15 days of:

(a) The name and address of persons who have received these machines;

(b) The manufacturer, model, and serial number of each radiation machine transferred; and

(c) The date of transfer of each radiation machine.

(d) In the case of diagnostic x-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the Federal diagnostic x-ray standard (21 CFR 1020.30(d)) shall be submitted to the Agency within 15 days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.

(2) 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 and use, meet the requirements of this rule.

M. Out-of-state radiation machines.

(1) Whenever any radiation machine is to be brought into the State, for any temporary use, the person proposing to bring such machine into the State shall give written notice to the Agency at least two working days before such machine is to be used in the State. The notice shall include:

(a) The type of radiation machine;

(b) The nature, duration, and scope of use;

(c) The exact location(s) where the radiation machine is to be used; and

(d) The states in which this machine is registered.

(2) If, for a specific case, the two working-day period would impose an undue hardship on the person, upon notification to the Agency, permission to proceed sooner may be granted.

(3) The person referred to in F.3.M.(1) shall:

(a) Comply with all applicable regulations of the Agency, to include the necessary inspection and registration fees;

(b) Supply the Agency with such other information as the Agency may reasonably request; and

(c) Not operate within the State on a temporary basis in excess of 90 calendar days per year.

10-144 C.M.R. ch. 220, § F-3