CMS SOM App. C, Tag D5429

(a)(1) Maintenance as defined by the manufacturer and with at least the frequency

specified by the manufacturer.

Interpretive Guidelines §493.1254(a)(1)

“As defined by the manufacturer” means that the laboratory must comply with the

maintenance required in package inserts and/or instrument operator manuals for each

piece of equipment/instrument it uses, including those that are peripherally involved in

patient testing (e.g., incubators, centrifuges, safety cabinets, autoclaves and microscopes).

We encourage laboratories to also comply with the manufacturer’s maintenance

recommendations.

A laboratory’s maintenance program is categorized into two parts:

• Unscheduled repairs when needed; and

• Scheduled preventive maintenance (PM), which includes maintenance by the

laboratory (e.g., daily, weekly, monthly, etc.), is performed to prevent

breakdowns or malfunctions, to prolong the life of an instrument and to maintain

optimum operating characteristics.

The laboratory is responsible to ensure the performance of all manufacturer-required

maintenance regardless of any service contract.

A service contract for PM from an outside source is acceptable provided that for each

instrument or piece of equipment, there is a description of the service to be performed

and frequency of service.

Acceptable performance parameters (if applicable) must be documented.

The laboratory must perform and document maintenance as specified by the

manufacturer for the LIS computer and devices such as monitors, printers and modems.

All devices must be maintained to ensure accurate, clear, and interference-free

transmission.

Probes §493.1254(a)(1)

Are LIS system components (e.g., server, hard drives, disk packs) maintained according

to the manufacturer’s instructions?

When downtime is required to perform maintenance on LIS equipment, how are LIS

users notified?

How does the laboratory’s maintenance program ensure that instruments and equipment

maintain optimum operating characteristics and minimize breakdowns?

and minimize breakdowns?