US · guidance
CMS SOM App. C, Tag D5433
§493.1254 Standard: Maintenance and function checks
(b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and
test system performance that is necessary for accurate and reliable test results and
test result reporting.
(b)(1)(ii) Perform and document the maintenance activities specified in paragraph
b(1)(i) of this section.
Interpretive Guidelines §493.1254(b)(1)(i)-(1)(ii)
NOTE: Refer to §493.1254(a)(1)
Probes §493.1254(b)(1)(i)-(1)(ii)
How does the laboratory’s maintenance program ensure that instruments and equipment
maintain optimum operating characteristics and minimize breakdowns?
Has the laboratory evaluated whether any modifications it has made to a manufacturer’s
instrument or piece of equipment has resulted in the need for additional maintenance or
function checks, and, if so, have the additional procedures been established and
implemented?
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
ea08829ab7a1888e4eb219e4163a7c61a614ec40587996db1e45977af6928871
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