R9-17-404.07. Adding or Removing Parameters for Testing

A. During the term of a laboratory registration certificate, an owner may request to have one or more parameters: 1. Added to the laboratory registration certificate, or 2. Removed from the laboratory registration certificate. B. To request a change to one or more parameters, an applicant shall submit to the Department: 1. The following information in a Department-provided format: a. The name, address, and telephone number of the applicant; b. The name, address, and telephone number of the laboratory for which the change is requested; c. If requesting the removal of a parameter, identification of the parameter to be removed; d. If requesting the addition of a parameter: i. The analyte to be tested for; ii. The instruments and equipment to be used for testing; iii. The software to be used at the laboratory for instrument control and data reduction interpretation; and iv. The limit of quantitation, if applicable; e. Whether the laboratory is ready for an inspection by the Department; 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; g. An attestation that the information provided to the Department to apply for the addition of a parameter is true and correct; and 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. The following for each parameter requested to be added: a. A copy of current accreditation; b. A copy of a proficiency testing report; c. A copy of the standard operating procedure; and d. Documentation of the initial demonstration of capabilities, according to R9-17-404.03(D); and 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. 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. 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.