1. A. The licensee shall:

   1. (1) Separately perform a validation or conduct a performance check on standard methods before use;
   2. (2) Validate non-standard methods, laboratory designed methods, laboratory designed tests, and modifications of standard methods before use; and
   3. (3) Maintain documentation of all method validation and performance check activities.

2. B. A licensee shall ensure that validation includes, but is not limited to:

   1. (1) Literature references;
   2. (2) Limitations of the method;
   3. (3) Sources of error;
   4. (4) Specificity;
   5. (5) Sensitivity;
   6. (6) Accuracy; and
   7. (7) Reproducibility.

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

   1. (1) Before:

      1. (a) Initial use of computers and automated equipment; and
      2. (b) Computers or automated equipment are returned to use for casework;
   2. (2) Following servicing or maintenance;
   3. (3) At intervals specified by the manufacturer; and
   4. (4) As needed as determined by the laboratory director or the laboratory director’s designee.
4. D. A technical leader and a laboratory director shall approve all testing methods before the testing methods are put into use.

5. E. A licensee shall ensure that:

   1. (1) Reference samples are used for method validation and performance checks;
   2. (2) Validation and performance checks include a statement as to whether the method is fit for the intended use; and
   3. (3) All new procedures and modifications of current procedures are validated and documented before being used in case work.

Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland

Effective date: May 28, 2012 (39:10 Md. R. 660)

Regulation .01K amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .02A, B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .05C amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .07C amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .09C, D amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .10B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .12B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .15A, C amended effective July 20, 2015 (42:14 Md R. 880)