Q&A column

Editor: Frederick L. Kiechle, MD, PhD

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Q. If an instrument is moved a short distance, is it necessary to conduct revalidation?

A. January 2021—The CAP checklist requirements do not specify how far an instrument must travel before it is considered a move. It is the laboratory’s responsibility to ensure instruments function properly and performance is not affected by relocation. Some moves may require more extensive checks and verification processes than others. The relocation process could cause damage, regardless of distance. Furthermore, how an instrument performs in a new location could be affected by environmental conditions, such as temperature, humidity, or sunlight, or other factors, such as water source or types of personnel using it. Moves also may involve an extended downtime that could negatively affect an instrument.

Some instruments, such as handheld point-of-care testing analyzers, are intended to be portable. The requirements for checking performance and method performance specifications after a move would not apply to these instruments.

Laboratories should refer to the manufacturer’s manual for critical requirements regarding setup, limitations, and environmental conditions. Instrument performance checks should include completing scheduled maintenance and instrument function checks, such as start-up and calibration processes, per the manufacturer’s instructions. Method performance specifications, such as accuracy, precision, and reportable range, must be verified at the location where testing will be performed. The laboratory may also wish to contact the manufacturer for further recommendations.

After the move, the laboratory must perform verification studies using an appropriate number of samples, as determined by the laboratory based on the extent of the move, to show that performance parameters were not affected by the relocation process.

Clinical and Laboratory Standards Institute. EP10-A3-AMD: Preliminary Evaluations of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline. 3rd ed. CLSI; 2014.

Standard: Establishment and Verification of Performance Specifications. 42 CFR §493.1253. https://j.mp/e-CFR493.