Section R3-5-112. Licensing Time-frames

A.      Overall time-frame. The Department shall issue or deny a lab- oratory certification within the overall time-frames listed in

Table 1 after receipt of an application. The overall time-frame is the total of the number of days provided for the administra- tive completeness review and the substantive review.

B.       Administrative completeness review.

1.        The applicable administrative completeness review time- frame established in Table 1 begins on the date the Department receives an application. The Department shall notify the applicant in writing within the administra- tive completeness review time-frame whether the appli- cation is incomplete. The notice shall specify the information that is missing. If the Department does not provide notice to the applicant within the administrative completeness review time-frame, the application is com- plete.

2.        An applicant with an incomplete certification application shall supply the missing information within the comple- tion request period established in Table 1. The adminis- trative completeness review time-frame is suspended from the date that the Department mails the notice of missing information to the applicant until the date that the Department receives the information.

3.        If the applicant fails to submit the missing information before expiration of the completion request period, the Department shall close the file, unless the applicant requests an extension. An applicant whose file has been closed may obtain laboratory certification by submitting a new application.

4.        If an applicant requests laboratory certification of a new service, the Department shall add 90 days to the adminis- trative completeness review time-frame to provide time for establishing a protocol for granting certification.

C.      Substantive review. The substantive review time-frame estab- lished in Table 1 begins on the date that the application is administratively complete.

1.        On-site survey.

a.        Within 30 days after receipt of a complete applica- tion, the SAL shall schedule an on-site survey of an applicant’s laboratory facilities.

b.        The Assistant Director may waive the on-site survey for a renewal applicant if the renewal applicant is in compliance with the other provisions of this Article.

2.        If the Department makes a comprehensive written request for additional information, the applicant shall submit the additional information identified by the request within the additional information period provided in Table 1. The substantive review time-frame is suspended from the date that the Department mails the request until the informa- tion is received by the Department. If the applicant fails to provide the information identified in the written request within the additional information period, the Department shall deny the certification.

3.        If laboratory certification is denied, the Department shall send the applicant written notice explaining:

a.        The reason for the denial with citations to supporting statutes or rules;

b.        The applicant’s right to appeal the denial;

c.        The period for appealing the denial; and

d.        The name and telephone number of a Department contact person who can answer questions regarding the appeals process.

Historical Note

New Section made by final rulemaking at 10 A.A.R. 3959, effective November 13, 2004 (Supp. 04-3).