[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR486.108]



[Page 640-641]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY 

 

       Subpart C_Conditions for Coverage: Portable X-Ray Services

 

Sec.  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.



------------------------------------------------------------------------

                                             Total filtration (inherent

              Operating kVp                         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.



[[Page 641]]



    (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]