The (b)(6) department of state health services uses specimen gate laboratory (sgl), a software product provided by perkinelmer.Sgl contains a database and possesses functionality which enables laboratories to track specimens as they navigate through the laboratory with audit trails, security, and handling logic based on customer rules for qc, result-to-reference range analysis, result flagging, etc.Sgl is a class i medical device intended to store, retrieve, and process the data.The (b)(6) department of state health services newborn screening laboratory uses the perkinelmer specimen gate laboratory (sgl), version 2015.When the software is deployed, configurable settings are programmed based on the customer preferences.For instance, each laboratory enters their specific population based reference ranges that are used to evaluate if a patient's test results are normal, below or above the reference range and require further action such as repeat testing.In this incident, the results of a newborn dried blood spot sample tested on june 26, 2015 were reported as normal on (b)(6) 2015 for citrulline analysis although the tested value for the analyte was above the established reference range cut-off.Due to the elevated citrulline measurement, the sample should have been retested prior to reporting; however, the cut-off was incorrect within the software due to a transposition of numbers upon entry.The cut-off was entered as 150 instead of the intended 105.The sample was retested on (b)(6) 2015 after discovery of the error.The repeat citrulline results were well below the corrected cut-off.No update to the previously released report was necessary.There was no impact to patient welfare and no effective delay in reporting.
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