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Q & A, 5/13

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Editor: Frederick L. Kiechle, MD, PhD
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Submit your pathology-related question for reply by appropriate medical consultants. CAP TODAY will make every effort to answer all relevant questions. However, those questions that are not of general interest may not receive a reply. For your question to be considered, you must include your name and address; this information will be omitted if your question is published in CAP TODAY.

Submit a Question [hr] [pulledquote]Q. We are relocating to a new laboratory on a different floor in our hospital. There is little guidance from regulatory agencies on revalidating analyzers after the move. Decisions are left to the discretion of our pathologist. What kind of precision/accuracy/ normal range/patient sample/control testing do you recommend?[/pulledquote]

A. The equipment manufacturer should be consulted for specific guidance on correct procedures for instrument relocation. The manufacturer may have field service personnel who can perform the relocation and the necessary checks to ensure that the instrument is performing to specification after the move.

The correct equipment shutdown protocol should be followed. Depending on the equipment, a shutdown may secure moving parts, such as fluid-handling elements, and optics, so they are less likely to be disturbed during instrument relocation.

After relocation, the manufacturer’s and laboratory’s protocols for checking instrument function after a major service should be followed. For all assays, the analytical measurement range should be revalidated after a major instrument service. Calibration verification or recalibration should be performed. Quality control materials and a number of patient samples should be retested, and the acceptability of the results should be confirmed. Precision studies are recommended, especially around medical decision limits. We suggest retesting at least 20 patient specimens on several assays; however, the laboratory director is responsible for determining the number and types of analyses to validate the operation of the instrument after relocation. Finally, interfaces to the laboratory information system should be tested at the new location.

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