1. A. During the term of a laboratory registration certificate, an owner may request to have one or more parameters:

   1. 1. Added to the laboratory registration certificate, or
   2. 2. Removed from the laboratory registration certificate.

2. B. To request a change to one or more parameters, an applicant shall submit to the Department:

   1. 1. The following information in a Department-provided format:

      1. a. The name, address, and telephone number of the applicant;
      2. b. The name, address, and telephone number of the laboratory for which the change is requested;
      3. c. If requesting the removal of a parameter, identification of the parameter to be removed;

      4. d. If requesting the addition of a parameter:

         1. i. The analyte to be tested for;
         2. ii. The instruments and equipment to be used for testing;
         3. iii. The software to be used at the laboratory for instrument control and data reduction interpretation; and
         4. iv. The limit of quantitation, if applicable;
      5. e. Whether the laboratory is ready for an inspection by the Department;
      6. f. If the laboratory is not ready for an inspection by the Department, the date the laboratory will be ready for an inspection by the Department;
      7. g. An attestation that the information provided to the Department to apply for the addition of a parameter is true and correct; and
      8. h. The signatures of the owner of the laboratory, according to R9-17-401(A), and the technical laboratory director and the date each signed;

   2. 2. The following for each parameter requested to be added:

      1. a. A copy of current accreditation;
      2. b. A copy of a proficiency testing report;
      3. c. A copy of the standard operating procedure; and
      4. d. Documentation of the initial demonstration of capabilities, according to R9-17-404.03(D); and
   3. 3. If applicable, any changes to the quality assurance plan in R9-17-404.05(B) made due to the addition or removal of the parameter.
3. C. The Department may conduct a laboratory inspection during the substantive review period for a request to have one or more parameters added to a laboratory registration certificate.
4. D. The Department shall process a request to have one or more parameters added to a laboratory registration certificate as provided in R9-17-107.

Historical Note

New Section made by exempt rulemaking at 26 A.A.R. 734, with an immediate effective date of April 2, 2020 (Supp. 20-2). Amended by exempt rulemaking at 26 A.A.R. 1905, with an immediate effective date of August 28, 2020 (Supp. 20-3). Amended by final rulemaking at 29 A.A.R. 2396 (October 13, 2023), effective October 1, 2023 (Supp. 23-3).