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Authority:
Secs. 1102, 1861(s) (3), (11) and (12), 1864, and 1871 of the Social Security Act (42 U.S.C. 1302, 1395x(s) (3), (11), and (12), 1395aa and 1395hh). Source:
34 FR 388, Jan. 10, 1969, unless otherwise noted. Redesignated at 42 FR 52826, Sept. 30, 1977, and further redesignated and amended at 60 FR 2326, Jan. 9, 1995. The supplier of portable X-ray services is in conformity with all applicable Federal, State, and local laws and regulations. (a) Standard—licensure or registration of supplier. In any State in which State or applicable local law provides for the licensure or registration of suppliers of X-ray services, the supplier is (1) licensed or registered pursuant to such law, or (2) approved by the agency of the State or locality responsible for licensure or registration as meeting the standards established for such licensure or registration. (b) Standard—licensure or registration of personnel. All personnel engaged in operating portable X-ray equipment are currently licensed or registered in accordance with all applicable State and local laws. (c) Standard—licensure or registration of equipment. All portable X-ray equipment used in providing portable X-ray services is licensed or registered in accordance with all applicable State and local laws. (d) Standard—conformity with other Federal, State, and local laws and regulations. The supplier of portable X-ray services agrees to render such services in conformity with Federal, State, and local laws relating to safety standards. [34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 45086, Aug. 30, 1995] § 486.102 Condition for coverage: Supervision by a qualified physician.Portable X-ray services are provided under the supervision of a qualified physician. (a) Standard—physician supervision. The performance of the roentgenologic procedures is subject to the supervision of a physician who meets the requirements of paragraph (b) of this section and one of the following requirements is met: (1) The supervising physician owns the equipment and it is operated only by his employees, or (2) The supervising physician certifies annually that he periodically checks the procedural manuals and observes the operators' performance, that he has verified that equipment and personnel meet applicable Federal, State, and local licensure and registration requirements and that safe operating procedures are used. (b) Standard—qualifications of the physician supervisor. Portable X-ray services are provided under the supervision of a licensed doctor of medicine or licensed doctor of osteopathy who is qualified by advanced training and experience in the use of X-rays for diagnostic purposes, i.e., he (1) is certified in radiology by the American Board of Radiology or by the American Osteopathic Board of Radiology or possesses qualifications which are equivalent to those required for such certification, or (2) is certified or meets the requirements for certification in a medical specialty in which he has become qualified by experience and training in the use of X-rays for diagnostic purposes, or (3) specializes in radiology and is recognized by the medical community as a specialist in radiology. [34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 45086, Aug. 30, 1995] § 486.104 Condition for coverage: Qualifications, orientation and health of technical personnel.Portable X-ray services are provided by qualified technologists. (a) Standard-qualifications of technologists . All operators of the portable X-ray equipment meet the requirements of paragraphs (a)(1), (2), (3), or (4) of this section: (1) Successful completion of a program of formal training in X-ray technology in a school approved by the Joint Review Committee on Education in Radiologic Technology (JRCERT), or have earned a bachelor's or associate degree in radiologic technology from an accredited college or university. (2) For those whose training was completed prior to July 1, 1966, but on or after July 1, 1960: Successful completion of 24 full months of training and/or experience under the direct supervision of a physician who is certified in radiology by the American College of Radiology or who possesses qualifications which are equivalent to those required for such certification, and at least 12 full months of pertinent portable X-ray equipment operation experience in the 5 years prior to January 1, 1968. (3) For those whose training was completed prior to July 1, 1960: Successful completion of 24 full months of training and/or experience of which at least 12 full months were under the direct supervision of a physician who is certified in radiology by the American College of Radiology or who possesses qualifications which are equivalent to those required for such certification, and at least 12 full months of pertinent portable X-ray equipment operation experience in the 5 years prior to January 1, 1968. (4) For those whose training was completed prior to January 1, 1993, successful completion of a program of formal training in X-ray technology in a school approved by the Council on Education of the American Medical Association, or by the American Osteopathic Association is acceptable. (b) Standard—personnel orientation. The supplier of portable X-ray services has an orientation program for personnel, based on a procedural manual which is: Available to all members of the staff, incorporates relevant portions of professionally recognized documents, and includes instruction in all of the following: (1) Precautions to be followed to protect the patient from unnecessary exposure to radiation; (2) Precautions to be followed to protect an individual supporting the patient during X-ray procedures from unnecessary exposure to radiation; (3) Precautions to be followed to protect other individuals in the surrounding environment from exposure to radiation; (4) Precautions to be followed to protect the operator of portable X-ray equipment from unnecessary exposure to radiation; (5) Considerations in determining the area which will receive the primary beam; (6) Determination of the time interval at which to check personnel radiation monitors; (7) Use of the personnel radiation monitor in providing an additional check on safety of equipment; (8) Proper use and maintenance of equipment; (9) Proper maintenance of records; (10) Technical problems which may arise and methods of solution; (11) Protection against electrical hazards; (12) Hazards of excessive exposure to radiation. (c) Standard: Employee records. Records are maintained and include evidence that— (1) Each employee is qualified for his or her position by means of training and experience; and (2) Employees receive adequate health supervision. [34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977, and amended at 53 FR 12015, Apr. 12, 1988; 60 FR 45086, Aug. 30, 1995; 73 FR 69942, Nov. 19, 2008] § 486.106 Condition for coverage: Referral for service and preservation of records.All portable X-ray services performed for Medicare beneficiaries are ordered by a doctor of medicine or doctor of osteopathy and records are properly preserved. (a) Standard—referral by a physician. Portable X-ray examinations are performed only on the order of a doctor of medicine or doctor of osteopathy licensed to practice in the State. The supplier's records show that: (1) The X-ray test was ordered by a licensed doctor of medicine or doctor of osteopathy, and (2) Such physician's written, signed order specifies the reason an X-ray test is required, the area of the body to be exposed, the number of radiographs to be obtained, and the views needed; it also includes a statement concerning the condition of the patient which indicates why portable X-ray services are necessary. (b) Standard—records of examinations performed. The supplier makes for each patient a record of the date of the X-ray examination, the name of the patient, a description of the procedures ordered and performed, the referring physician, the operator(s) of the portable X-ray equipment who performed the examination, the physician to whom the radiograph was sent, and the date it was sent. (c) Standard—preservation of records. Such reports are maintained for a period of at least 2 years, or for the period of time required by State law for such records (as distinguished from requirements as to the radiograph itself), whichever is longer. [34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 45086, Aug. 30, 1995] § 486.108 Condition for coverage: Safety standards.X-ray examinations are conducted through the use of equipment which is free of unnecessary hazards for patients, personnel, and other persons in the immediate environment, and through operating procedures which provide minimum radiation exposure to patients, personnel, and other persons in the immediate environment. (a) Standard—tube housing and devices to restrict the useful beam. The tube housing is of diagnostic type. Diaphragms, cones, or adjustable collimators capable of restricting the useful beam to the area of clinical interest are used and provide the same degree of protection as is required of the housing. (b) Standard—total filtration. (1) The aluminum equivalent of the total filtration in the primary beam is not less than that shown in the following table except when contraindicated for a particular diagnostic procedure.
(2) If the filter in the machine is not accessible for examination or the total filtration is unknown, it can be assumed that the requirements are met if the half-value layer is not less than that shown in the following table:
(c) Standard—termination of exposure. A device is provided to terminate the exposure after a preset time or exposure. (d) Standard—control panel. The control panel provides a device (usually a milliammeter or a means for an audible signal to give positive indication of the production of X-rays whenever the X-ray tube is energized. The control panel includes appropriate indicators (labelled control settings and/or meters) which show the physical factors (such as kVp, mA, exposure time or whether timing is automatic) used for the exposure. (e) Standard—exposure control switch. The exposure control switch is of the dead-man type and is so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam. (f) Standard—protection against electrical hazards. Only shockproof equipment is used. All electrical equipment is grounded. (g) Standard—mechanical supporting or restraining devices. Mechanical supporting or restraining devices are provided so that such devices can be used when a patient must be held in position for radiography. (h) Standard—protective gloves and aprons. Protective gloves and aprons are provided so that when the patient must be held by an individual, that individual is protected with these shielding devices. (i) Standard—restriction of the useful beam. Diaphragms, cones, or adjustable collimators are used to restrict the useful beam to the area of clinical interest. (j) Standard—personnel monitoring. A device which can be worn to monitor radiation exposure (e.g., a film badge) is provided to each individual who operates portable X-ray equipment. The device is evaluated for radiation exposure to the operator at least monthly and appropriate records are maintained by the supplier of portable X-ray services of radiation exposure measured by such a device for each individual. (k) Standard—personnel and public protection. No individual occupationally exposed to radiation is permitted to hold patients during exposures except during emergencies, nor is any other individual regularly used for this service. Care is taken to assure that pregnant women do not assist in portable X-ray examinations. [34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 45086, Aug. 30, 1995] § 486.110 Condition for coverage: Inspection of equipment.Inspections of all X-ray equipment and shielding are made by qualified individuals at intervals not greater than every 24 months. (a) Standard—qualified inspectors. Inspections are made at least every 24 months by a radiation health specialist who is on the staff of or approved by an appropriate State or local government agency. (b) Standard—records of inspection and scope of inspection. The supplier maintains records of current inspections which include the extent to which equipment and shielding are in compliance with the safety standards outlined in §486.108. [34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 45086, Aug. 30, 1995; 60 FR 50447, Sept. 29, 1995] Browse Previous | Browse Next
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