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a) Approval of roentgenographic faities given prior to January 1, 1976, all terminate upon August 1, 1978 un38 each of the following conditions ve been met:
(1) The facility must verify that it ill meets the requirements set forth the regulations for the second round
roentgenographic examinations (38 R 20076) and it has not changed equipent since it was approved by NIOSH. (2) From July 27, 1973, to January 1, 76, the facility submitted to ALOSH ; least 50 roentgenograms which were terpreted by one or more "B" readers ot employed by the facility who found o more than 5 percent of all the roentenograms unreadable.
(b) Other facilities will be eligible to articipate in this program when they emonstrate their ability to make high uality diagnostic chest roentgenorams by submitting to ALOSH six or nore sample chest roentgenograms nade and processed at the applicant facility and which are of acceptable qualty to the Panel of "B" readers. Applicants shall also submit 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
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 Xray 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, 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]
§ 37.43 Protection against radiation emitted by roentgenographic equipment.
Except as otherwise specified in §37.41, roentgenographic equipment, its use and the facilities (including mobile facilities) in which such equipment is used, shall conform to applicable State
and Federal regulations (See 21 CFR part 1000). Where no applicable regulations exist, roentgenographic equipment, its use and the facilities (including mobile facilities) in which such equipment is used shall conform to the recommendations of the National
Council on Radiation Protection and Measurements in NCRP Report No. 33 "Medical X-ray and Gamma-Ray Protection for Energies up to 10 MeVEquipment Design and Use" (issued February 1, 1968), in NCRP Report No. 48, "Medical Radiation Protection for Medical and Allied Health Personnel" (issued August 1, 1976), and in NCRP Report No. 49, "Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of up to 10 MeV" (issued September 15, 1976). These documents are hereby incorporated by reference and made a part of this subpart. These documents are available for examination at ALOSH, 944 Chestnut Ridge Road, Morgantown, WV 26505, and at the National Institute for Occupational Safety and Health, 5600 Fishers Lane, Rockville, MD 20857. Copies of NCRP Reports Nos. 33, 48, and 49 may be purchased for $3, $4.50, and $3.50 each, respectively, from NCRP Publications, P.O. Box 30175, Washington, DC 20014.
of Radiographs for Pneumoconiose 1980.
NOTE: This set is available from the Inter national Labor Office, 1750 New York Are nue, NW., Washington, DC 20006 (Phone: 376-2315).
(d) In all view boxes used for making interpretations:
(1) Fluorescent lamps shall be simultaneously replaced with new lamps &: 6-month intervals;
(2) All the fluorescent lamps in panel of boxes shall have identical manufacturer's ratings as to intensity and color;
(3) The glass, internal reflective surfaces, and the lamps shall be kept clean;
(4) The unit shall be so situated as to minimize front surface glare.
[43 FR 33715, Aug. 1, 1978, as amended at $ FR 7564, Mar. 1, 1984]
(1) Approval as an "A" reader sha continue if established prior to (insert effective date of these regulations).
(2) Physicians who desire to be "A" readers must demonstrate their proficiency in classifying pneumoconioses by either:
(i) Submitting to ALOSH from the physician's files six sample chest roentgenograms which are considered properly classified by the Panel of "B" readers. The six roentgenograms shall consist of two without pneumoconiosis. two with simple pneumoconiosis, and two with complicated pneumoconiosis The films will be returned to the physi cian. The interpretations shall be on the Roentgenographic Interpretation Form (Form CDC/NIOSH (M) 2.8) (These may be the same roentgeno grams submitted pursuant to §37.42)
(ii) Satisfactory completion, since June 11, 1970, of a course approved by ALOSH on the ILO or ILO-U/C Classi fication systems or the UICC/Cincinnati classification system. As used in this subparagraph, “UICC/Cincinnati classification" means the classification of the pneumoconioses devised in 1968 by a Working Committee of the International Union Against Cancer.
(b) Final or "B" readers:
(1) Approval as a "B" reader established prior to October 1, 1976, shall hereby be terminated.
(2) Proficiency in evaluating chest roentgenograms for roentgenographic quality and in the use of the ILO Classification for interpreting chest roentgenograms for pneumoconiosis and other diseases shall be demonstrated by those physicians who desire to be "B" readers by taking and passing a specially designed proficiency examination given on behalf of or by ALOSH at a time and place specified by ALOSH. Each physician must bring a complete set of the ILO standard reference radiographs when taking the examination. Physicians who qualify under this provision need not be qualified under paragraph (a) of this section. (c) Physicians who wish to participate in the program shall make application on an Interpreting Physician Certification Document (Form CDC/ NIOSH (M) 2.12).
[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984]
§ 37.52 Method of obtaining definitive interpretations.
(a) All chest roentgenograms which are first interpreted by an "A" or "B" reader will be submitted by ALOSH to a "B" reader qualified as described in §37.51. If there is agreement between the two interpreters as defined in paragraph (b) of this section the result shall be considered final and reported to MSHA for transmittal to the miner. When in the opinion of ALOSH substantial agreement is lacking, ALOSH shall obtain additional interpretations from the Panel of "B" readers. If interIpretations are obtained from two or more "B" readers, and if two or more are in agreement then the highest major category shall be reported.
(b) Two interpreters shall be considered to be in agreement when they both find either stage A, B, or C complicated pneumoconiosis, or their findings with regard to simple pneumoconiosis are both in the same major category, or (with one exception noted below) are within one minor cat5egory
(ILO Classification 12-point scale) of each other. In the last situation, the higher of the two interpreta
tions shall be reported. The only exception to the one minor category principle is a reading sequence of 0/1, 1/0, or 1/0, 0/1. When such a sequence occurs, it shall not be considered agreement, and a third (or more) interpretation shall be obtained until a consensus involving two or more readings in the same major category is obtained.
[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984; 52 FR 7866, Mar. 13, 1987] $37.53 Notification of abnormal roentgenographic findings.
(b) In addition, when ALOSH has more than one roentgenogram of a miner in its files and the most recent examination was interpreted to show enlarged heart, tuberculosis, cancer, complicated pneumoconiosis, and any other significant abnormal findings, ALOSH will submit all of the miner's roentgenograms in its files with their respective interprtations to a "B" reader. The "B" reader will report any significant changes or progression of disease or other comments to ALOSH and ALOSH shall submit a copy of the report to the miner's designated physician.
(c) All final findings regarding pneumoconiosis will be sent to the miner by MSHA in accordance with section 203 of the act (see 30 CFR part 90). Positive findings with regard to pneumoconiosis will be reported to the miner's designated physician by ALOSH.
(d) ALOSH will make every reasonable effort to process the findings described in paragraph (c) of this section within 60 days of receipt of the infor
mation described in §37.60 in a complete and acceptable form. The information forwarded to MSHA will be in a form intended to facilitate prompt dispatch of the findings to the miner. The results of an examination made of a miner will not be processed by ALOSH if the examination was made within 6 months of the date of a previous acceptable examination.
required chest roentgenograms and miner identification documents.
(a) Each chest roentgenogram required to be made under this subpart, together with the completed roentgenographic interpretation form and the completed miner identification document, shall be sumitted together for each miner to ALOSH within 14 calendar days after the roentgenographic examination is given and become the property of ALOSH.
(b) If ALOSH deems any part submitted under paragraph (a) of this section inadequate, it will notify the operator of the deficiency. The operator shall promptly make appropriate arrangements for the necessary reexamination.
(c) Failure to comply with paragraph (a) or (b) of this section shall be cause to revoke approval of a plan or any other approval as may be appropriate. An approval which has been revoked may be reinstated at the discretion of ALOSH after it receives satisfactory assurances and evidence that all deficiencies have been corrected and that effective controls have been instituted to prevent a recurrence.
(d) Chest roentgenograms and other required documents shall be submitted only for miners. Results of preemployment physical examinations of persons who are not hired shall not be submitted.
(e) If a miner refuses to participate in all phases of the examination prescribed in this subpart, no report need be made. If a miner refuses to participate in any phase of the examination prescribed in this subpart, all the forms shall be submitted with his or her name and social security account number on each. If any of the forms cannot be completed because of the miner's refusal, it shall be marked "Miner Refuses," and shall be submit
ted. No submission shall be made, how ever, without a completed miner iden tification document containing the miner's name, address, social security number and place of employment.
REVIEW AND AVAILABILITY OF RECORDE
§ 37.70 Review of interpretations.
(a) Any miner who believes the inter pretation for pneumoconiosis reported to him or her by MSHA is in error may file a written request with ALOSH that his or her roentgenogram be reevaluated. If the interpretation was based of agreement between an “A” reader and a "B" reader, ALOSH will obtain one or more additional interpretations by "B" readers as necessary to obtain agreement in accord with §37.52(b), and MSHA shall report the results to the miner together with any rights which may accrue to the miner in accordance with §37.7. If the reported interpretation was based on agreement betweez two (or more) “B” readers, the reading will be accepted as conclusive and the miner shall be so informed by MSHA.
(b) Any operator who is directed by MSHA to transfer a miner to a less dusty atmosphere based on the most recent examination made subsequent to August 1, 1978, may file a written request with ALOSH to review its findings. The standards set forth in paragraph (a) of this section apply and the operator and miner will be notified by MSHA whether the miner is entitled to the option to transfer.
§ 37.80 Availability of records.
(a) Medical information and roentgenograms on miners will be released by ALOSH only with the written consent from the miner, or if the miner is deceased, written consent from the miner's widow, next of kin, or legal representative.
(b) To the extent authorized, roentgenograms will be made available for examination only at ALOSH.
AUTHORITY: Sec. 508, 83 Stat. 803; 30 U.S.C.
SOURCE: 36 FR 8870, May 14, 1971, unless otherwise noted.
As used in this subpart:
(a) Secretary means the Secretary of ealth and Human Services.
(b) Miner means any individual who tring his life was employed in any unerground coal mine.
(c) Pathologist means
(1) A physician certified in anatomic thology or pathology by the Ameran Board of Pathology or the Ameran Osteopathic Board of Pathology, (2) A physician who possesses qualications which are considered "Board f eligible" by the American Board of athology or American Osteopathic oard of Pathology, or
; (3) An intern, resident, or other phyician in a training program in patholgy who performs the autopsy under he supervision of a pathologist as deined in paragraph (c) (1) or (2) of this ection.
; (d) ALFORD means the Appalachian Laboratory for Occupational Resiratory Diseases, Public Health Servce, Department of Health and Human Services, Post Office Box 4257, MorganSown, WV 26505.
37.202 Payment for autopsy.
(a) The Secretary will pay up to $200 So any pathologist who, after the effective date of the regulations in this part and with legal consent.
(1) Performs an autopsy on a miner in accordance with this subpart; and
(2) Submits the findings and other materials to ALFORD in accordance with this subpart within 180 calendar days after having performed the autopsy; and
(3) Receives no other specific payment, fee, or reimbursement in connection with the autopsy from the miner's widow, his family, his estate, or any other Federal agency.
(b) The Secretary will pay to any pathologist entitled to payment under paragraph (a) of this section and additional $10 if the pathologist can obtain $ and submits a good quality copy or
original of a chest roentgenogram (posteroanterior view) made of the subject of the autopsy within 5 years prior to his death together with a copy of any interpretation made.
[35 FR 13206, Aug. 19, 1970, as amended at 38 FR 16353, June 22, 1973]
§ 37.203 Autopsy specifications.
(a) Every autopsy for which a claim for payment is submitted pursuant to this part:
(1) Shall be performed consistent with standard autopsy procedures such as those, for example, set forth in the "Autopsy Manual" prepared by the Armed Forces Institute of Pathology, July 1, 1960. (Technical Manual No. 8300. NAVMED P-5065, Air Force Manual No. 160-19.) Copies of this document may be borrowed from ALFORD.
(2) Shall include:
(i) Gross and microscopic examination of the lungs, pulmonary pleura, and tracheobronchial lymph nodes;
(ii) Weights of the heart and each lung (these and all other measurements required under this subparagraph shall be in the metric system);
(iii) Circumference of each cardiac valve when opened;
(iv) Thickness of right and left ventricles; these measurements shall be made perpendicular to the ventricular surface and shall not include trabeculations or pericardial fat. The right ventricle shall be measured at a point midway between the tricuspid valve and the apex, and the left ventricle shall be measured directly above the insertion of the anterior papillary muscle;
(v) Size, number, consistency, location, description and other relevant details of all lesions of the lungs;
(vi) Level of the diaphragm;
(vii) From each type of suspected pneumoconiotic lesion, representative microscopic slides stained with hematoxylin eosin or other appropriate stain, and one formalin fixed, paraffinimpregnated block of tissue; a minimum of three stained slides and three blocks of tissue shall be submitted. When no such lesion is recognized, similar material shall be submitted from three separate areas of the lungs selected at random; a minimum of three stained slides and three formalin