CMS SOM App. A, Tag A-0537

be properly corrected.

Interpretive Guidelines §482.26(b)(2)

The hospital must have policies and procedures in place to ensure that periodic inspections of

radiology equipment are conducted, current and that problems identified are corrected in a timely

manner. Equipment includes not only devices used to deliver diagnostic or therapeutic

radiologic services, but also exposure meters, badges, or personal radiation monitoring devices

used by staff, as well as equipment the hospital uses to inspect or calibrate devices used to

deliver diagnostic or therapeutic radiologic services. The hospital must ensure that equipment is

inspected in accordance with manufacturer’s instructions and Federal and State laws, regulations,

and guidelines, and hospital policy, as applicable. Inspections and maintenance, including

correction of identified hazards, must be performed by qualified employees (e.g., medical

physicists, qualified biomedical technicians, etc.) or through contractual arrangements with

vendors with appropriate expertise.

Hospitals must follow the manufacturer’s instructions as to how to inspect and maintain

radiologic equipment. This includes acceptance testing (i.e., upon initial installation and after

major upgrades) as well as ongoing inspection and maintenance. Documentation of preventive

maintenance, quality control tests, service records, and major software/hardware upgrades must

be maintained by the hospital and be readily available for inspection.

The hospital must also have a system in place, to identify and remedy equipment hazards in a

timely manner. This system must include, but is not limited to: periodic and consistent

calibration of equipment and, for equipment using ionizing radiation, monitoring of dosimetry

parameters with phantoms to ensure that an accurate dose of radiation is delivered per the

applicable protocol. In addition, hospitals must also have a system to track all modifications

made to the equipment that would significantly impact the accuracy of the dosage delivered.

Any adverse events related to over- or under-dosing must be identified and addressed.

For Information Only - Not Required/Not to be Cited

Requirements for Manufacturers Re: Instructions that Must be Made Available

Below is an FDA summary of its requirements for manufacturers of x-ray systems to make

available to purchasers and, upon request, to other parties, information related to maintenance

of the following types of systems:

• For all diagnostic x-ray systems, manufacturers are required to provide to purchasers, and,

upon request, to others at a cost not to exceed the cost of publication and distribution,

manuals or instruction sheets that include technical and safety information (21 CFR

1020.30(h). This information must include a schedule of the maintenance necessary to

keep the equipment in compliance with §§1020.30, 1020.31, 1020.32, and 1020.33 (21

CFR 1020.30(h)(1)(ii)). Manufacturers are also required to provide to assemblers, and,

upon request, to others at a cost not to exceed the cost of publication and distribution,

instructions for assembly, installation, adjustment, and testing of specified components of

diagnostic x-ray systems adequate to ensure that the products will comply with applicable

provisions of §§1020.30, 1020.31, 1020.32, and 1020.33, when assembled, installed,

adjusted, and tested as directed (21 CFR 1020.30(g)).

• In addition to the requirements applicable to all diagnostic x-ray systems, there are also

other requirements for specific systems:

• Manufacturers of fluoroscopic x-ray systems manufactured on or after June 10, 2006

are required to provide a schedule of maintenance for any system instrumentation

associated with the display of air kerma information necessary to maintain the displays

of air kerma rate and cumulative air kerma within the limits of allowed uncertainty

specified by 21 CFR 1020.32(k)(6). And, if the capability for user calibration of the

display is provided, adequate instructions for such calibration must be supplied (21

CFR 1020.30(h)(6)(i)).

• Manufacturers of computed tomography (CT) systems are required to provide a

specific phantom or phantoms for quality assurance testing of specific system

parameters on these systems (21 CFR 1020.33(d)(1)), and instructions on the use of the

phantom(s), including a schedule of testing appropriate for the system and allowable

variations for the indicated parameters (21 CFR 1020.33(d)(2)).

• Manufacturers of cabinet x-ray systems are required to provide purchasers, and others,

upon request, at a cost not to exceed the cost of preparation and distribution, manuals

and instructions. These documents must include, among other technical and safety

information, a schedule of maintenance necessary to keep the system in compliance

with 21 CFR 1020.40 (21 CFR 1020.40(c)(9)(i)). Cabinet x-ray systems that are

intended to be assembled or installed by the purchaser must be accompanied by

instructions for assembly, installation, adjustment and testing of the cabinet x-ray

adequate to ensure that the system is in compliance with the applicable provisions of

21 CFR 1020.40 when assembled, installed, adjusted and tested as directed (21 CFR

1020.40(c)(9)(ii)).

Survey Procedures §482.26(b)(2)

• Review the inspection records (logs) to verify that periodic inspections are conducted in

accordance with Federal and State laws, regulations and manufacturer’s instructions.

• Verify that inspection and maintenance activities were performed by qualified individuals

• Verify that the maintenance logs show documentation of the calibration upon installation and

after major upgrades or servicing.

• Review with the appropriate personnel the inspection schedule and the mechanism for

identifying hazards, including accurate dosimetry determinations with phantom patients, as

applicable.

• Determine that any problems identified through the testing and maintenance program are

properly corrected in a timely manner and the correction is maintained over time.