10.51.05.07

.07 Validation and Performance Checks.

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;

(4) Specificity;

(5) Sensitivity;

(6) Accuracy; and

(7) Reproducibility.

C. A licensee shall ensure that performance checks, if applicable, are performed:

(1) Before:

(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 directorís 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.