42 C.F.R. § 37.42   Approval of roentgenographic facilities.


Title 42 - Public Health


Title 42: Public Health
PART 37—SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF UNDERGROUND COAL MINERS
Subpart—Chest Roentgenographic Examinations
Specifications for Performing Chest Roentgenographic Examinations

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§ 37.42   Approval of roentgenographic facilities.

(a) Approval of roentgenographic facilities given prior to January 1, 1976, shall terminate upon August 1, 1978 unless each of the following conditions have been met:

(1) The facility must verify that it still meets the requirements set forth in the regulations for the second round of roentgenographic examinations (38 FR 20076) and it has not changed equipment since it was approved by NIOSH.

(2) From July 27, 1973, to January 1, 1976, the facility submitted to ALOSH at least 50 roentgenograms which were interpreted by one or more “B” readers not employed by the facility who found no more than 5 percent of all the roentgenograms unreadable.

(b) Other facilities will be eligible to participate in this program when they demonstrate their ability to make high quality diagnostic chest roentgenograms by submitting to ALOSH six or more sample chest roentgenograms made and processed at the applicant facility and which are of acceptable quality to the Panel of “B” readers. Applicants shall also submit a roentgenogram of a plastic step-wedge object (available on loan from ALOSH) which was made and processed at the same time with the same technique as the roentgenograms submitted and processed at the facility for which approval is sought. At least one chest roentgenogram and one test object roentgenogram shall have been made with each unit to be used hereunder. All roentgenograms shall have been made within 15 calendar days prior to submission and shall be marked to identify the facility where each roentgenogram was made, the X-ray machine used, and the date each was made. The chest roentgenograms will be returned and may be the same roentgenograms submitted pursuant to §37.51.

Note: The plastic step-wedge object is described in an article by E. Dale Trout and John P. Kelley appearing in “The American Journal of Roentgenology, Radium Therapy and Nuclear Medicine,” Vol. 117, No. 4, April 1973.

(c) Each roentgenographic facility submitting chest roentgenograms for approval under this section shall complete and include an X-ray facility document describing each X-ray unit to be used to make chest roentgenograms under the act. The form shall include: (1) The date of the last radiation safety inspection by an appropriate licensing agency or, if no such agency exists, by a qualified expert as defined in NCRP Report No. 33 (see §37.43); (2) the deficiencies found; (3) a statement that all the deficiencies have been corrected; and (4) the date of acquisition of the X-ray unit. To be acceptable, the radiation safety inspection shall have been made within 1 year preceding the date of application.

(d) Roentgenograms submitted with applications for approval under this section will be evaluated by the panel of “B” Readers or by a qualified radiological physicist or consultant. Applicants will be advised of any reasons for denial of approval.

(e) ALOSH or its representatives may make a physical inspection of the applicant's facility and any approved roentgenographic facility at any reasonable time to determine if the requirements of this subpart are being met.

(f) ALOSH may require a facility periodically to resubmit roentgenograms of a plastic step-wedge object, sample roentgenograms, or a Roentgenographic Facility Document for quality control purposes. Approvals granted hereunder may be suspended or withdrawn by notice in writing when in the opinion of ALOSH the quality of roentgenograms or information submitted under this section warrants such action. A copy of a notice withdrawing approval will be sent to each operator who has listed the facility as its facility for giving chest roentgenograms and shall be displayed on the mine bulletin board adjacent to the operator's approved plan. The approved plan will be reevaluated by ALOSH in light of this change.

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978]

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