1. A. Facility Administration. A licensee shall ensure that a laboratory:

   1. (1) Is adequate for the testing services offered;
   2. (2) Has lighting, plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the laboratory’s requirements; and
   3. (3) Has the required safety equipment as defined by the laboratory SOPM.

2. B. Security. A licensee shall:

   1. (1) Control and limit access to areas of the laboratory to those persons who regularly work in an area or are designated by the laboratory director as having access to an area; and

   2. (2) Ensure that:

      1. (a) Entrances and exits have adequate security measures;
      2. (b) Internal areas that are required to have controlled or limited access are protected by a locked system;
      3. (c) The distribution of all keys, magnetic cards, and entry devices is documented and authorized by the director;
      4. (d) The facility is secure; and
      5. (e) All short-term and long-term storage areas have controlled or limited access and have a lock system in place.

3. C. Safety. A licensee shall:

   1. (1) Have a safety policy and procedure, that is reviewed annually;
   2. (2) Designate an employee as the safety officer with responsibilities defined by the licensee;
   3. (3) Have appropriate safety policies and procedures;
   4. (4) Demonstrate appropriate safety policies and procedures;
   5. (5) Have appropriate safety devices and equipment available and in close proximity to the appropriate areas; and
   6. (6) Be in compliance with all federal, State, and local regulations regarding the handling and disposal of infectious materials, chemicals, radioactive materials, sharps, and glassware.

Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland

Effective date: May 28, 2012 (39:10 Md. R. 660)

Regulation .01K amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .02A, B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .05C amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .07C amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .09C, D amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .10B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .12B amended effective July 20, 2015 (42:14 Md R. 880)

Regulation .15A, C amended effective July 20, 2015 (42:14 Md R. 880)