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.
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.
Portable X-ray services are provided by qualified technologists.
(1) Successful completion of a program of formal training in X-ray technology at which the operator received appropriate training and demonstrated competence in the use of equipment and administration of portable x-ray procedures; or
(2) Successful completion of 24 full months of training and experience under the direct supervision of a physician who is certified in radiology or who possesses qualifications which are equivalent to those required for such certification.
(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.
All portable X-ray services performed for Medicare beneficiaries are ordered by a physician or a nonphysician practitioner as provided in § 410.32(a) of this chapter or by a nonphysician practitioner as provided in § 410.32(a)(2) and records are properly preserved.
(a) Standard - referral by a physician or nonphysician practitioners. Portable X-ray examinations are performed only on the order of a physician licensed to practice in the State or by a nonphysician practitioner acting within the scope of State law. Such nonphysician practitioners may be treated the same as physicians treating beneficiaries for the purpose of this paragraph. The supplier's records show that:
(1) The portable X-ray test was ordered by a licensed physician or a nonphysician practitioner acting within the State scope of law; and
(2) Such physician or non-physician practitioner's order meets the requirements at § 410.32 of this chapter, and 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 portable X-ray examination, the name of the patient, a description of the procedures ordered and performed, the referring physician or nonphysician practitioner, 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; 77 FR 69372, Nov. 16, 2012; 84 FR 51830, Sept. 30, 2019]
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.
|Operating kVp||Total filtration (inherent plus added)|
|Below 50 kVp||0.5 millimeters aluminum.|
|50-70 kVp||1.5 millimeters aluminum.|
|Above 70 kVp||2.5 millimeters aluminum.|
(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:
|Operating kVp||Half-value layer|
|50 kVp||0.6 millimeters aluminum.|
|70 kVp||1.6 millimeters aluminum.|
|90 kVp||2.6 millimeters aluminum.|
|100 kVp||2.8 millimeters aluminum.|
|110 kVp||3.0 millimeters aluminum.|
|120 kVp||3.3 millimeters aluminum.|
(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.
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.