Is it required to maintain logs for waived testing?

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Any examples are for illustrative purposes only.

The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:

client identifier
date of testing
test kit lot number
test result, QC lot numbers
QC results
testing personnel identifier

Logs are useful for compiling this information in one comprehensive document. Alternatively, the organization may choose to document this information in the client chart or utilize a combination of document sources to correlate the information. For example, an organization performing occult blood testing elects to document the date of testing, client result, QC result and testing personnel initials in the client chart. A separate inventory log is maintained to track the lot of reagents and test cards in use at the time of testing. Performance of initial QC for the lot, when required by the organization's policy, could also be documented on the inventory log prior to releasing the kit for general use.

Manual: Home Care

Chapter: Waived Testing WT

First published date: April 11, 2016