Validation is required when: (Choose all that apply)A) new personnel are hired.B) a new instrument is purchased.C) a new lot of reagents are put into use.D) a delta check is obtained.
What will be an ideal response?
B, C
Validation is required when a new instrument is purchased and a new lot of controls or reagents are put into use. When new personnel are hired, they undergo training and a competency assessment. A delta check requires a review of current and previous test results on the patient for whom the delta check occurred. This may be followed by repeat analysis, follow up with healthcare provider as to possible change in patient status, and recollection and testing of new specimen.
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