Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants
Section 10.10.13.07 - Director Requirement, Qualifications, and Responsibilities

Universal Citation: MD Code Reg 10.10.13.07

Current through Register Vol. 51, No. 19, September 20, 2024

A. Director Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a director.

B. Director Qualifications. The director shall:

(1) Meet the qualifications for a medical laboratory director set forth at COMAR 10.10.07.04C; and

(2) Possess a current license as a laboratory director issued by the state in which the laboratory is located if:
(a) The laboratory is not located in Maryland; and

(b) Licensing is required by the state in which the laboratory is located.

C. Director Responsibilities. The director is responsible for:

(1) The overall operation and administration of the laboratory, including the employment of a sufficient number of competent personnel;

(2) Ensuring that each first-tier, supplemental, or second-tier test conducted is performed accurately and reliably in all aspects of the testing process, including the preanalytic, analytic, and post-analytic phases of the total testing process; and

(3) Ensuring compliance with:
(a) This chapter;

(b) The applicable parts of COMAR 10.10.01- 10.10.08; and

(c) COMAR 10.52.12.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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