CMS SOM App. H, Tag V403

The dialysis facility must implement and

maintain a program to ensure that all equipment (including emergency equipment, dialysis

machines and equipment, and the water treatment system) are maintained and operated in

accordance with the manufacturer’s recommendations.

Interpretive Guidance §494.60 (b)

All equipment used at the dialysis facility and dialysis equipment used by home dialysis patients

must be maintained in a safe and functional working condition. The facility’s program for

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preventive maintenance and repair of all equipment must be in accordance with the equipment

manufacturer’s instructions.

Staff must operate and maintain the equipment in accordance with manufacturer’s instructions.

Malfunctioning machines awaiting repair must be removed from service and should be labeled

or tagged to prevent use. The facility should have a plan for the operation and routine

maintenance of at least the following equipment and equipment systems:

Hemodialysis delivery system:

• High flux dialyzers may only be used with machines specified by the manufacturer as

capable of accurately monitoring and controlling fluid removal.

• If heparin pumps are incorporated into the delivery system, the pumps must be

maintained as clean and functional.

• As required by manufacturers, testing of safety features, e.g., alarms, pressure

holding tests, and independent verification of dialysate pH and conductivity should be

conducted prior to each dialysis treatment.

“Dummy” drip chambers:

• “Dummy” drip chambers are fluid-filled chambers that are used to bypass the

dialysis machine’s air detectors.

• The practice of using a “dummy” drip chamber to prepare a dialysis machine for

patient use is hazardous to patient safety and risks the undetected infusion of air into

a patient if the “dummy” drip chamber is not removed at the initiation of dialysis.

• The presence and availability of “dummy” drip chambers in the hemodialysis patient

treatment area is considered an immediate and serious threat to patient health and

safety. Unintentional failure to remove the “dummy drip chamber” from the air

detector places the patient at risk for potential life-threatening events including air

embolism and other possible adverse effects as use of a dummy drip chamber during

a patient’s dialysis treatment would be inconsistent with the manufacturer’s DFU.

• Use of a dummy drip chamber on the treatment floor departs from the standards of

care for dialysis. The use of dummy drip chambers in dialysis facilities is referenced

in several clinical studies, and warnings against using dummy drip chambers in the

treatment area are included in nearly all manufacturers’ instructions. The use of

“dummy” drip chambers in the dialysis facility is typically reserved for machine

maintenance purposes and is only used outside of the patient treatment area.

Water treatment system:

Requirements for monitoring and maintenance of the water treatment system are incorporated

into the Condition for water and dialysate quality at § 494.40 and should be cited there.

Dialyzer reprocessing system:

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Requirements for monitoring and maintenance of dialyzer reprocessing systems are incorporated

into the Conditions for Reuse of Hemodialyzers and Bloodlines at § 494.50 and should be cited

there.

Ancillary equipment:

• Ancillary equipment may include, but is not limited to: functional and clean patient

scales, centrifuge, refrigerators, incubators for in-house performance of

water/dialysate cultures, emergency generators, blood pressure monitoring

equipment, infusion pumps, patient thermometers, eye wash stations, conductivity and

pH meters, Hoyer lifts, and equipment required to provide in-house laboratory testing

(e.g. blood glucose meters, heat blocks, equipment for activated clotting times (ACT),

supplies for testing for occult blood and hematocrit levels).

• Maintenance of refrigerators should include the monitoring of temperatures to ensure

these are appropriate for the items stored.

• If a generator is present, documentation should be available regarding testing and

maintenance per the manufacturer’s instructions.

• Records should be available regarding the daily cleaning, testing, and periodic

calibration of pH and conductivity meters as recommended by the manufacturer.

• Documentation of periodic calibration of patient scales, blood pressure devices,

blood volume monitors, and laboratory equipment, as applicable, should be

available.

Emergency equipment:

Emergency equipment as referenced at E-0028 of Appendix Z should be clean, functional, and

accessible. Use E-0028 for the lack of required emergency equipment; use this tag for failure to

maintain the emergency equipment.

Furniture:

• Patient treatment chairs, facility wheelchairs, and waiting area chairs must be

maintained to allow effective cleaning/disinfection.

• Torn upholstery must be repaired or replaced; broken mechanisms (e.g. footrests,

reclining levers) must be repaired or the equipment removed from use.

The facility equipment maintenance program should include documentation regarding all

equipment or devices used for home patients, whether maintained by the facility or by durable

medical equipment suppliers (DME). Refer to the Condition for Care at home at V597 if

problems with the maintenance and/or exchange of home dialysis equipment are identified.