Sec. 10.10.03.04. Letter of Exception and Permit — Administrative Procedures

A. Application - Filing.

(1) Except for a laboratory eligible for a multi-site license as set forth in Regulation .01D(3)(b) of this chapter, a person shall apply for a license for each laboratory location.

(2) A person holding a license to operate a laboratory in the discipline of chemistry or health awareness testing is not required to obtain a separate cholesterol testing permit to conduct cholesterol testing at a temporary laboratory site if the licensee complies with the requirements applicable to a temporary laboratory as set forth in this subtitle.

(3) A person shall complete and file an application for a license using forms provided by the OHCQ.

(4) A person shall complete on the application a description of laboratory services, which includes but is not limited to:

(a) Types of tests performed or to be performed;

(b) Total number of tests performed or to be performed annually, excluding tests for quality control and proficiency testing; and

(c) Qualifications of personnel who direct, supervise, and perform laboratory testing.

(5) The laboratory director shall sign the application forms attesting that the information provided is accurate and that the laboratory is or will be operated in accordance with the requirements and standards required in this chapter.

(6) A person shall submit with the application the nonrefundable partial licensing fee set forth in COMAR 10.10.04.02C.

B. Application - Evaluation and Billing.

(1) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if an application is complete.

(2) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the laboratory is eligible for a:

(a) Letter of exception;

(b) Letter of exception - limited testing for rare diseases; or

(c) Permit.

C. Application - Denial of License. If the OHCQ determines that a laboratory is not in compliance with the requirements of this chapter and therefore cannot be issued a license, the OHCQ shall provide to the laboratory:

(1) A written statement of the grounds on which the denial is based; and

(2) The opportunity to:

(a) Amend and resubmit the application; or

(b) Request, in writing, an opportunity for a hearing as provided in the Administrative Procedure Act, State Government Article, §§10-201-10-226, and Health-General Article, §§17-210 and 17-509, Annotated Code of Maryland.

D. Notification Requirements. A licensee shall notify the OHCQ within 30 days of a change in laboratory:

(1) Ownership;

(2) Name;

(3) Location; or

(4) Director.

E. Amending a Permit. Except as prescribed in §D of this regulation, a licensee holding an unexpired permit who wishes to amend it shall:

(1) Submit a written request for amendment to the Secretary; and

(23) Obtain written approval from the OHCQ before implementing the amendment.

F. Expiration and Renewal.

(1) A letter of exception or permit expires on the date shown on the license.

(2) The OHCQ shall mail a renewal application to a laboratory not less than 30 days before the expiration date shown on the license.

(3) A licensee shall file an application to renew a license using forms provided by the OHCQ and following the same procedures prescribed in §§A and B of this regulation.

(4) A licensee who fails to submit a completed renewal application before the expiration date may not operate the laboratory after its letter of exception or permit has expired.

G. Non-Transferability. A license is not transferable between laboratories, directors, or locations.