# COMAR Title 10 — Maryland Department of Health

## Subtitle 51 — Forensic Laboratories

### Chapter 05 — Quality Assurance

#### Regulation .07 Validation and Performance Checks.

*COMAR 10.51.05.07*

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 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.