Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part F - X-RAYS IN THE HEALING ARTS › Section 144-220-F-3 - General requirements

Current through 2024-29, July 17, 2024
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.