The licensee shall: Separately perform a validation or conduct a performance check on standard methods before use; Validate non-standard methods, laboratory designed methods, laboratory designed tests, and modifications of standard methods before use; and Maintain documentation of all method validation and performance check activities. A licensee shall ensure that validation includes, but is not limited to: Literature references; Limitations of the method; Sources of error; Specificity; Sensitivity; Accuracy; and Reproducibility. A licensee shall ensure that performance checks, if applicable, are performed: Before: Initial use of computers and automated equipment; and Computers or automated equipment are returned to use for casework; Following servicing or maintenance; At intervals specified by the manufacturer; and As needed as determined by the laboratory director or the laboratory director’s designee. A technical leader and a laboratory director shall approve all testing methods before the testing methods are put into use. A licensee shall ensure that: Reference samples are used for method validation and performance checks; Validation and performance checks include a statement as to whether the method is fit for the intended use; and All new procedures and modifications of current procedures are validated and documented before being used in case work.