Equipment Maintenance Logs

42 CFR § 493.1254(a)–(b)

Maintenance and function checks

Follow and document manufacturer maintenance and function-check instructions at least as frequently as specified. Function checks must meet established limits before patient testing. For modified or in-house equipment, or when manufacturer protocols are absent, establish and document appropriate laboratory protocols.

Brief source excerpt“Maintenance as defined by the manufacturer”

Brief source excerpt“Function checks must be within the manufacturer's established limits”

42 CFR § 493.1254 — maintenance and function checks

42 CFR § 493.1252(b)

Operating conditions

Define, monitor, and document conditions essential to reliable operation, including applicable temperature, water-quality, humidity, and electrical-supply conditions. Follow manufacturer criteria where provided.

Brief source excerpt“These conditions must be monitored and documented”

42 CFR § 493.1252 — equipment and testing conditions

42 CFR § 493.1282(b)(1)(i)

Corrective actions

Document corrective actions when equipment operates outside established parameters or performance specifications. Link the action to the affected equipment, check, and record.

Brief source excerpt“The laboratory must document all corrective actions taken”

42 CFR § 493.1282 — corrective actions

CAP PUBLIC GUIDE · PRINTED PAGE 26

Grossing station

Address ventilation and formalin-exposure monitoring. Set station cleaning and equipment checks from the manufacturer’s instructions and laboratory procedures.

CAP guide — grossing environment, printed page 26

CAP PUBLIC GUIDE · PRINTED PAGE 41

Embedding center

Address paraffin temperature, heated components, forceps and surface cleaning, and reservoir or filter care.

Brief source excerpt“Temperature of embedding paraffin – monitored daily”

CAP guide — embedding, printed page 41

CAP PUBLIC GUIDE · PRINTED PAGES 37–40

Tissue processor

Define maintenance responsibilities, reagent-change intervals appropriate to workload, and reservoir cleaning.

CAP guide — tissue processing, printed pages 37–40

CAP PUBLIC GUIDE · PRINTED PAGES 44–45

Stainer

Address reagent schedules, stain-quality controls, corrective actions, and preventive servicing.

Brief source excerpt“Establish a preventative maintenance program that includes annual service and emergency service.”

CAP guide — H&E staining, printed pages 44–45

CAP PUBLIC GUIDE · PRINTED PAGES 54–55

Coverslipper

Address cleaning, reagents, filters, and preventive servicing according to the instrument’s instructions and the laboratory’s procedures.

CAP guide — coverslipping, printed pages 54–55