Regulation .07 Validation and Performance Checks.

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.

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.

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 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:

(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.