Eileen Posted June 5, 2018 Share Posted June 5, 2018 We enter analyzer results manually into our BB computer system. Do these results need to be reviewed for Quality Assurance purposes? What kind of quality check does BB manual test result entry require? Link to comment Share on other sites More sharing options...
Dansket Posted June 5, 2018 Share Posted June 5, 2018 We print an individual Results report for each specimen which is identified by a barcoded sample ID label affixed by the operator. The operator then scans the sample ID from the Results report into Meditech enters and files the results. The printed report is then filed in the Supervisor's Review basket. As Supervisor, I repeat the process for each individual report and verify results on report match results entered in Meditech. I sign and date the report and file the report in a binder. This binder is made available for inspectors to indicate this Quality Review process. Link to comment Share on other sites More sharing options...
R1R2 Posted June 6, 2018 Share Posted June 6, 2018 These are just a couple of CAP requirements that deal with result review: GEN.43825 Result Verification - Manual and automated result entries are verified before final acceptance and reporting by the computer. An audit after the fact would not satisfy this requirement. COM.04100 Deals with Supervisory Result Review and all results need to be reviewed within 24 hours if high complexity testing is performed by trainined high school grads. It would also be a good idea to audit a percentage of results after the fact too if you are manually entering results into an LIS. Link to comment Share on other sites More sharing options...
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