§ 221.35a. Fluoroscopic X-ray systems.
(a) General requirements. Fluoroscopic X-ray systems shall use an image intensifier and, in addition to the requirements of § § 221.1—221.34a, shall meet the requirements of § § 221.36a—221.38a (relating to limitation of useful beam of fluoroscopic equipment; activation of fluoroscopic tube; and entrance exposure rate).
(b) Operator qualifications. In addition to the applicable sections of these regulations, the operation of a fluoroscopic X-ray system for clinical purposes is limited to:
(1) A licensed practitioner working within his scope of practice.
(2) A Department-recognized radiologist assistant working within his scope of practice and under the direct supervision of a licensed practitioner working within his scope of practice.
(3) An individual who passed the American Registry of Radiologic Technologists exam or equivalent, holds a valid certification and is under the personal supervision of a licensed practitioner working within his scope of practice.
(4) A medical resident, radiologist assistant or radiologic technology student in training who is under the personal supervision of a licensed practitioner working within his scope of practice.
(c) QMP evaluations. Fluoroscopic equipment shall be evaluated by or under the direction of a QMP within 30 days after installation and after any maintenance of the system that may affect the exposure rate. Thereafter, evaluations shall be made at intervals not to exceed 14 months from the date of the prior evaluation by or under the direction of a QMP. At a minimum, evaluations shall include all of the following:
(1) A measurement of entrance exposure rates over a representative range of attenuating materials in all modes clinically used, including fluoroscopy, high-level control, acquisition and CINE, when available. Measurements shall be performed with a dosimetry system calibrated within 2 years preceding the measurements. Records of these output measurements shall be maintained for 5 years for inspection by the Department. Measurements shall be made as follows:
(i) For systems without automatic exposure control, by utilizing an mA and kVp typical of the clinical use of the fluoroscopic system.
(ii) For systems with automatic exposure control, by utilizing sufficient attenuating material in the useful beam to produce an mA and kVp typical of the clinical use of the fluoroscopic system.
(2) A measurement and verification of compliance with maximum air kerma rate for fluoroscopy and high-level control, if available.
(3) An evaluation of high-contrast resolution and low-contrast resolution in both fluoroscopic and spot-film or digital acquisition modes.
(4) An evaluation of the operation of the 5-minute timer, warning lights, interlocks and collision sensors.
(5) An evaluation of the beam quality.
(6) An evaluation of the collimation in the fluoroscopy and spot-film or digital acquisition modes.
(7) An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.
(8) An evaluation of any changes that may impact patient and personnel exposure.
(d) Additional requirements for facilities performing FGI.
(1) The registrant utilizing FGI studies shall establish and implement written procedures, or procedures documented in an electronic reporting system, that include all of the following:
(i) Identification of individuals who are authorized to use fluoroscopic systems for interventional purposes.
(ii) A method to be used to monitor patient radiation dose during FGI.
(iii) Dose notification levels, as appropriate, at which the physician is notified for actions that may be taken for patient safety.
(iv) SRDL values referencing or consistent with nationally-recognized standards.
(v) Actions to be taken for cases when an SRDL is exceeded, which may include patient follow-up.
(vi) A review of the established procedures at an interval not to exceed 12 months.
(2) Records of policies and procedures shall be maintained for inspection by the Department. If the registrant revises a policy or procedure, documentation shall be maintained that includes the justification for the revision.
(3) A record of radiation output information shall be maintained so the radiation dose to the skin may be estimated in accordance with established protocols. The record must include all of the following:
(i) Patient identification.
(ii) Type and date of examination.
(iii) Identification of the fluoroscopic system used.
(iv) Peak skin dose, cumulative air kerma or dose area product used if the information is available on the fluoroscopic system.
(4) If the peak skin dose, cumulative air kerma or dose area product is not displayed on the fluoroscopic system, records must include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or one or more of the following:
(i) Fluoroscopic mode, such as high-level or pulsed mode of operation.
(ii) Cumulative fluoroscopic exposure time.
(iii) Number of films or recorded exposures.
(5) The registrant shall maintain records for 5 years for inspection by the Department.
Authority The provisions of this § 221.35a issued and amended under sections 301 and 302 of the Radiation Protection Act (31 P.S. § § 7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 221.35a adopted October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial page (304503).
Cross References This section cited in 25 Pa. Code § 221.43a (relating to mobile fluoroscopes); and 25 Pa. Code § 221.61 (relating to radiation therapy simulation systems).
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