Automated cell counters (CBC analyzers) are required to have validation performed to verify that manufacturer's specifications are met by the specific instrument being installed. The validation process is specified for each instrument by the instrument manufacturer. Each type of specimen to be tested must undergo validation testing separately. For example, CBC analyzers that analyze body fluids must validate the analyzer for those specimens separately. Additional tests performed on whole blood, such as reticulocyte counts, must also be validated separately.
The validation process for an instrument or test system new to the laboratory may be performed by the trained laboratory personnel or a technical specialist in conjunction with a service engineer or a combination of these persons.
Inclusive steps are guided by CLIA '88 (as stated in the Code of Federal Regulations (CFR)), accreditation agencies, the vendor, and the laboratory's protocol. Trained laboratory personnel should participate in the validation process as appropriate.
As stated in CFR § 493.1253, verification of performance specifications for any test system introduced that is FDA-cleared or approved must include the following prior to reporting patient test results:
- Demonstrate that the test system can obtain test specifications comparable to those established by the manufacturer for the following performance characteristics including accuracy, precision, and reportable range for test results for the test system.
- Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population.
Additional studies including correlation studies with the previous analyzer, carryover studies, comparison of automated to manual differentials, instrument flag verification, and mixing studies may be included as required by the manufacturer, accreditation agencies, state regulations, or institution-specific protocol as defined by laboratory director or facility management.
