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