Ariz. Admin. Code § 9-17-404.07

Current through Register Vol. 30, No. 45, November 8, 2024

Section 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.

Ariz. Admin. Code § R9-17-404.07

Adopted by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by exempt rulemaking at 26 A.A.R. 968, effective 4/20/2020. Amended by final rulemaking at 29 A.A.R. 2396, effective 10/1/2023..