Featured Expert Article

Instrument reliability and QC frequency: a cautionary tale

by John Yundt-Pacheco  

Imagine this announcement: "Accuration Instruments Inc. is proud to announce the release of the Reliabulator 2/500, a new hallmark in the reliability of clinical diagnostic laboratory automation."

Your laboratory will be one of the first installations of the new Reliabulator 2/500. The manufacturer claims the "2" in the instrument name stands for an expected two years between undetected grave malfunctions, and the "500" means it will process 500 patient specimens per day.

One of the things you need to decide on is a suitable quality-control strategy for the Reliabulator. If it only fails every two years, does that mean no quality control (QC) is necessary the first year? That would certainly help the budget. After a bit more consideration, you realize that an expected malfunction rate of once every two years is not the same thing as a malfunction every two years starting after installation. The instrument could have an expected malfunction rate of once every two years and still malfunction the day after it is validated. An expected malfunction rate of once every two years means that the malfunction could occur at any time; but over the long term, there will be an average of one malfunction for every two years of service. Consequently, no QC during the first year is not much of an option.

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