CMS SOM App. C, Tag D5781

(b) The laboratory must document all corrective actions taken, including actions

taken when any of the following occur:

(b)(1) Test systems do not meet the laboratory’s verified or established performance

specifications, as determined in §493.1253(b), which include but are not limited to--

(b)(1)(i) Equipment or methodologies that perform outside of established operating

parameters or performance specifications;

(b)(1)(ii) Patient test values that are outside of the laboratory’s reportable range of

test results for the test system; and

(b)(1)(iii) When the laboratory determines that the reference intervals (normal

values) for a test procedure are inappropriate for the laboratory’s patient

population.

Interpretive Guidelines §493.1282(b)(1)

The laboratory’s corrective action records should contain sufficient information to

resolve the problem and prevent reoccurrence.

Probes §493.1282(b)(1)

When equipment malfunctions or a test method problem exists, how does the laboratory

identify and solve the problem?

What corrective actions are taken if patient test results fall outside of the laboratory’s

reportable range of patient test results?

If a dilution procedure is used when patient results exceed the test system’s reportable

range, how does the laboratory ensure the appropriate diluent is used for each type of

specimen? Use D5401.

How does the laboratory verify and document the accuracy of the results for diluted

specimens? Use D5421 or D5423 as appropriate.