410 IAC 5-6.1-118 - General requirements for operation of x-ray equipment

Authority: IC 16-41-35-26; IC 16-41-35-29

Affected: IC 16-41-35

Sec. 118.

(a) All individuals associated with the operation of x-ray equipment shall comply with applicable sections of 410 IAC 5-4-2, 410 IAC 5-4-3, 410 IAC 5-4-10, and this rule.
(b) The registrant shall be responsible for directing the operation of those x-ray systems under his or her administrative control. The registrant or the registrant's agent shall comply with this section in the operation of such x-ray systems.
(c) At intervals prescribed in this rule, all new and existing facilities shall be surveyed by a diagnostic imaging physicist, radiation oncology physicist, health physicist, or x-ray machine inspector approved by the department. Such surveys shall also be performed after any change in the facility or equipment which might cause a significant increase in radiation hazard. The survey shall be done before the x-ray system is used for diagnostic purposes, and an evaluation report, including all violations of this rule, on a form acceptable to the commissioner must be completed by the physicist or inspector and a copy forwarded to the registrant and to the commissioner within sixty (60) days of completion of the survey. The cost of this evaluation must be negotiated between the physicist or inspector and the practitioner of the healing arts or registrant and will not be borne by the department.
(d) For each x-ray system, a notice of compliance with this rule, supplied by or approved by the commissioner, shall be prominently displayed on or near the x-ray control panel. This notice must indicate the date of full compliance and be signed by the physicist or inspector. For fluoroscopy systems, this notice may incorporate the entrance exposure posting requirement of section 119(k)(6) of this rule.
(e) For each x-ray facility, a notice of compliance with this rule, supplied by or approved by the commissioner, shall be prominently displayed in an area readily accessible to patients and visitors. This notice must indicate the date of full compliance and be signed by the physicist or inspector.
(f) At the intervals prescribed for facility inspections in this rule, the registrant shall be responsible for completing an x-ray machine registration application form. A diagnostic imaging physicist, radiation oncology physicist, health physicist, or x-ray machine inspector approved by the department shall be responsible for verifying that all information on the application is correct, and the form shall be submitted to the commissioner as part of the physicist's or inspector's evaluation report.
(g) On the effective date of this rule, in order to practice as a diagnostic imaging physicist, radiation oncology physicist, health physicist, or x-ray machine inspector in accordance with this rule, an individual must be approved by the department in accordance with subsection (h), (i), (j), or (k).
(h) In order to be approved to practice as a diagnostic imaging physicist, an individual must be certified by the ABR in diagnostic radiological physics or radiological physics or the ABMP in diagnostic imaging physics or shall possess equivalent qualifications as determined by the physicist review committee established in subsection (l). In determining equivalency in accordance with this section, the physicist review committee shall determine the following:
(1) The individual shall hold a bachelor's degree in physics or applied physics or physical science.
(2) The individual shall hold a master's or doctoral degree in physics or medical physics or a physical science with the equivalent of a physics minor.
(3) The individual shall have completed formal course work in the biological sciences.
(4) The individual shall have at least three (3) years of full-time active work experience in diagnostic or radiological physics under the direction of a diagnostic or radiological physicist certified by the ABR or ABMP or a radiologist certified by the ABR.
(5) The individual shall provide as references the names of a radiologist certified by the ABR and a diagnostic or radiological physicist certified by the ABR or ABMP, both of whom are familiar with the individual's training. At least one (1) of the two (2) references shall have directed the individual's work in accordance with subdivision (4).

In addition, the applicant must demonstrate to the physicist review committee that he or she is qualified to provide oversight for the establishment and conduct of a mammography quality assurance program required by section 127 of this rule. In determining qualifications in accordance with this subsection, the physicist review committee shall do the following:

(6) Determine that the individual has formal training or experience in evaluation of mammography systems, including performing, recording, and interpreting the results of required quality control checks.
(7) Determine that the individual has adequate testing equipment available to perform the quality control checks required by section 127 of this rule.
(8) Review a sample of a mammographic x-ray facility evaluation report prepared and submitted by the individual as part of their determination of his or her qualifications.
(i) On the effective date of this rule, any individual who has been approved previously by the department to practice as a qualified radiation therapy physicist is automatically approved to practice as a radiation oncology physicist. However, after the effective date of this rule, all other persons must be certified by the ABR in therapeutic radiological physics or radiological physics or the ABMP in radiation oncology physics or shall possess equivalent qualifications as determined by the physicist review committee established in subsection (l), in order to be approved to practice as a radiation oncology physicist. In determining equivalency in accordance with this subsection, the physicist review committee shall determine the following:
(1) The individual shall hold a bachelor's degree in physics or applied physics or a physical science.
(2) The individual shall hold a master's or doctoral degree in physics or medical physics or a physical science with the equivalent of a physics minor.
(3) The individual shall have completed formal course work in the biological sciences.
(4) The individual shall have at least three (3) years of full-time active work experience in radiation oncology physics, under the direction of a radiation oncology physicist or radiological physicist certified by the ABR or ABMP or a radiation oncology physician certified by the ABR.
(5) The individual shall provide as references the names of a radiation oncology physician certified by the ABR and a radiation oncology physicist certified by the ABR or ABMP, both of whom are familiar with the individual's training. At least one (1) of these references shall be from an individual who directed the individual's work in accordance with subdivision (4).
(j) On the effective date of this rule, any individual who has been approved previously by the department to practice as a qualified radiation or health physicist is automatically approved to practice as a health physicist. However, after the effective date of this rule, all other persons must be certified by the ABR, the ABMP, or the ABHP or shall possess equivalent qualifications as determined by the physicist review committee established in subsection (l), in order to be approved to practice as a health physicist. In determining equivalency in accordance with this subsection, the physicist review committee shall determine the following:
(1) The individual shall hold a bachelor's degree in health physics, radiological health, a physical science, engineering, or a biological science with a minor in a physical science or engineering.
(2) The individual shall have at least three (3) years of full-time active work experience in applied health physics. A master's degree in health physics or a closely related area may substitute for one (1) year of work experience required by this subsection. A doctoral degree in health physics or a closely related area may substitute for two (2) years of work experience required by this subsection.
(k) On the effective date of this rule, any individual who has been approved previously by the department to practice as a qualified x-ray machine physicist is automatically approved to practice as an x-ray machine inspector. However, after the effective date of this rule, all other persons must have a minimum of a bachelor's degree in a physical or biological science, health physics, or radiological health and a minimum of two (2) years of experience working with x-ray systems under the direct supervision of a diagnostic imaging physicist, health physicist, or x-ray machine inspector, who has been approved by the department, in order to be approved to practice as an x-ray machine inspector.
(l) A physicist review committee is hereby created, which shall determine competency to practice as a diagnostic imaging physicist, radiation oncology physicist, health physicist, and x-ray machine inspector in accordance with subsection (h), (i), (j), or (k). The physicist review committee shall be composed of a diagnostic imaging physicist and a radiation oncology physicist, both certified by the ABR or ABMP, and a radiologist certified by the ABR. The diagnostic imaging physicist, the radiation oncology physicist, and the radiologist shall be appointed to the physicist review committee by the commissioner. Approval to practice as a diagnostic imaging physicist, radiation oncology physicist, health physicist, or x-ray machine inspector shall be based upon review of a completed application which demonstrates that the individual meets applicable education, training, and experience requirements of subsection (h), (i), (j), or (k).
(m) Approval to practice as a diagnostic imaging physicist, radiation oncology physicist, health physicist, or x-ray machine inspector may be revoked by the commissioner for failure to perform his or her duties as required by this rule. The commissioner may audit facility evaluations performed by a diagnostic imaging physicist, radiation oncology physicist, health physicist, or x-ray machine inspector. Any errors found as a result of such an audit shall be brought to the attention of the individual who performed the evaluation. If a subsequent audit indicates repetitive errors which have resulted in the issuance of unnecessary violation notices, or in violations not being reported to the commissioner, the commissioner may revoke that individual's approval to practice as a diagnostic imaging physicist, radiation oncology physicist, health physicist, or x-ray machine inspector.
(n) Department employees are exempt from the credentialing requirements of this section when they are conducting inspections or surveys of x-ray facilities for the commissioner.
(o) The radiation machine registration certificate issued by the commissioner in accordance with 410 IAC 5-2-6 shall be prominently displayed in an area readily accessible to patients and visitors.
(p) An x-ray system which does not comply with this rule shall not be operated for diagnostic or therapeutic purposes, if so directed by the commissioner.
(q) Individuals who will be operating the x-ray equipment shall be adequately instructed in proper operating procedures for such equipment. Diagnostic x-ray machines shall be operated only by a person who complies with applicable provisions of 410 IAC 5-11.
(r) In the vicinity of each x-ray control panel, a technique guide shall be provided for routine examinations performed utilizing that system.
(s) Written safety procedures and rules shall be available to each individual operating x-ray equipment, including any restrictions of operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.
(t) Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure. In addition to the patient being examined, others will be protected in the following manner:
(1) All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by five-tenths (0.5) mm lead equivalent.
(2) Staff and ancillary personnel shall be protected from direct scattered radiation by protective aprons or whole body protective barriers of not less than twenty-five hundredths (0.25) mm lead equivalent.
(3) Patients who cannot be removed from the room shall be protected from direct scattered radiation by whole body protective barriers of twenty-five hundredths (0.25) mm lead equivalent or shall be positioned so that portion of the body nearest to the tube head is at least two (2) meters from both the tube head and the nearest edge of the image receptor.
(u) Gonadal shielding of not less than twenty-five hundredths (0.25) mm lead equivalent shall be used for 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.
(v) Individuals shall not be exposed to the useful beam, except for healing arts purposes and such exposure has been authorized by a practitioner of the healing arts. This subsection specifically prohibits deliberate exposure for training, demonstration, or other nonhealing arts purposes.
(w) The following apply when a patient or film must be provided with auxiliary support during a radiation exposure:
(1) Mechanical holding devices shall be used when the technique permits. Written safety procedures established in accordance with subsection (s) shall list individual projections where holding devices cannot be utilized.
(2) Written safety procedures established in accordance with subsection (s) shall indicate the requirements for selecting a holder and the procedure the holder shall follow.
(3) The human holder shall be protected as required by subsection (t).
(4) No individual shall be used routinely to hold film or patients.

In those cases where the patient must hold the film, except during intraoral 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 five-tenths (0.5) mm lead equivalent material.

(x) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.
(y) Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.
(z) Any registrant proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the commissioner. When requesting such approval, that person shall submit all department required information. If any submitted information becomes invalid or outdated, the commissioner shall be immediately notified.
(aa) The registrant shall maintain the following information for each x-ray system for inspection by the commissioner:
(1) Maximum rating of technique factors.
(2) Model and serial numbers of all certified components.
(3) Aluminum equivalent filtration of the useful beam, including any routine variation.
(4) Records of surveys, calibrations, maintenance, and modifications performed on the x-ray systems for the following periods:
(A) For hospitals, medical facilities, and chiropractic facilities, twenty-four (24) months.
(B) For podiatric and veterinary facilities, forty-eight (48) months.
(C) For dental facilities, seventy-two (72) months.
(5) After the effective date of this rule, a scaled drawing of the room in which a stationary x-ray system is located, which indicates the use of areas adjacent to the room, and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall indicate either of the following:
(A) 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.
(B) The type and thickness of materials or the lead equivalency of each wall, window, door, ceiling, and floor in the room.
(6) A copy of all correspondence with the commissioner regarding each x-ray machine, including a copy of all facility evaluation reports issued in compliance with this section.
(bb) Floor plans and equipment arrangements for all new diagnostic x-ray installations, or modifications of such installations, shall be evaluated with regard to shielding requirements prior to construction. A safety survey shall be performed prior to first use. Both evaluations shall be performed by a diagnostic imaging physicist or a health physicist approved by the department.
(cc) Floor plans and equipment arrangements for all new therapeutic x-ray installations, or modifications of such installations, shall be evaluated with regard to shielding requirements prior to construction. A safety survey shall be performed prior to first use. Both evaluations shall be performed by a radiation oncology physicist or a health physicist approved by the department.
(dd) A report of each plan review and safety survey conducted in compliance with subsection (bb) or (cc) shall be submitted to the registrant and the commissioner within twenty (20) working days of completing the plan review, and the registrant shall keep a copy of the report in its files for at least as long as the registrant uses that x-ray facility.

Notes

410 IAC 5-6.1-118
Indiana State Department of Health; 410 IAC 5-6.1-118; filed Oct 29, 1993, 5:00 p.m.: 17 IR 367; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA Readopted filed 11/13/2019, 3:14 p.m.: 20191211-IR-410190391RFA

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