Ariz. Admin. Code § R13-15-103 - Instruments; Approvals, Standards, Authorizations

A. The Director may approve instruments used to perform Rapid DNA analysis as part of a law enforcement program after receiving a report from an accredited laboratory that successfully tested a typical model of the instrument for compliance with the standards in subsection (B).

B. The instrument shall meet the following standards of performance:

1. The instrument shall have a publicly-available developmental validation completed by the manufacturer which follows the requirements of the QAS and includes, where applicable:

a. Characterization of the genetic marker,

b. Species specificity,

c. Sensitivity studies,

d. Stability studies,

e. Reproducibility,

f. Case-type sample,

g. Population studies,

h. Mixture studies,

i. Precision and accuracy studies; and

j. PCR-based studies.

2. The instrument shall have an internal validation completed by the submitting accredited laboratory which follows the requirements of the QAS and includes, where applicable:

a. Known and mock evidence samples,

b. Precision and accuracy studies,

c. Sensitivity and stochastic studies,

d. Mixture studies; and

e. Contamination assessments.

3. The instrument shall allow the accredited laboratory performing the internal validation the ability to access, view and interpret raw data from the instrument in order to ensure the integrity of the analysis.

C. The accredited laboratory shall provide the following to the Department for approval of the Rapid DNA instrument:

1. A copy of the developmental validation,

2. A summary of the internal validation,

3. All data from the internal validation; and

4. Any additional supporting documentation or calculations needed to support the internal validation.

D. The Department, upon specific findings that a device is unreliable, inaccurate, or otherwise unable to meet the requirements of a validation, shall publish a disapproval of use of the instrument.

E. The following instrument is approved by the Director:

Instrument Device/Model	Manufacturer
RapidHIT ID	Thermofisher

F. Only Rapid DNA Operators are authorized to operate approved Rapid DNA instruments for use at law enforcement agencies.

G. The Director may publish a temporary approval of a Rapid DNA instrument that has been successfully tested for compliance with the standards in subsection B for use prior to and pending the instrument being added to subsection E. The temporary approval shall expire three years after its effective date.

Notes

Ariz. Admin. Code § R13-15-103

New section made by final rulemaking at 28 A.A.R. 998, effective 7/3/2022.