Sec. 10.10.06.12. Quality Control — Temporary and Mobile Laboratories: General

A. Primary Standard. The licensee shall ensure that a health awareness test or a job-related screening test for alcohol or controlled dangerous substances at a temporary or mobile laboratory is performed:

(1) Under effective supervision, quality control, and safety procedures;

(2) Using a previously evaluated analytical system; and

(3) For a job-related screening test for alcohol or controlled dangerous substances, only at the request of an individual authorized in COMAR 10.10.06.02.

B. Standards.

(1) Limited Tests. A person may perform at a temporary or mobile laboratory only the health awareness tests defined in COMAR 10.10.01.03B and job-related screening tests for alcohol or controlled dangerous substances.

(2) Health awareness and cholesterol testing may be performed at the request of the examinee. Staff who perform the tests shall have training and experience to perform testing that includes:

(a) Operation of the analyzers per manufacturer’s recommendations;

(b) Evaluation of the results of the quality controls;

(c) Interpretation of the test results; and

(d) Counseling to the individual whose specimen is tested.

(3) Supervision. A designated supervisor, knowledgeable in all aspects of the health awareness testing, shall be present at a temporary or mobile laboratory throughout a testing event to oversee testing, including compliance with all applicable requirements set forth in this chapter.

(4) Testing Sites.

(a) A person may not perform a health awareness test in a restaurant where food or drink is prepared, served, or consumed.

(b) A licensee shall ensure that a temporary laboratory:

(i) Provides space, when applicable, for counseling examinees regarding test results;

(ii) Provides space appropriate for the number of staff, analytical systems, and examinees;

(iii) Provides work space adequate to minimize problems of transportation, communication, and safety;

(iv) Provides electricity of the type and in the amount needed to operate analytical systems properly;

(v) Includes access to water and disinfectant supplies for routine cleaning and disinfection of the work area, equipment, and personnel;

(vi) Contains or is within 1 minute of a telephone with access to emergency assistance by calling 911;

(vii) Maintains levels of temperature, humidity, and ventilation to comply with manufacturer's specifications for effective operation of analytical systems;

(viii) Is situated a minimum of 12 feet from any produce, meat, or dairy department in a food market;

(ix) Maintains partitions, such as ropes, on at least three sides of an area where blood is drawn or processed, to prevent unsupervised access to a blood-drawing or testing area;

(x) Employs separate receptacles for routine laboratory and special medical wastes within partitioned testing areas;

(xi) Provides for the storage of reagents and other testing materials within temperatures recommended by the manufacturer; and

(xii) Complies with all pertinent State laws and local ordinances.

(5) Pre-Field Evaluation of Analytical Systems. A licensee may not employ an analytical system in a mobile or temporary laboratory until the laboratory has documented the analytical system's levels of accuracy and precision in a permanent laboratory facility.

(6) In-Field Quality Control. A licensee operating a mobile or temporary laboratory shall establish and maintain a continuous quality control program for an analytical system operated in that mobile or temporary laboratory.

(7) Phlebotomy Quality Control and Safety.

(a) A licensee employing a phlebotomist at a temporary or mobile laboratory shall ensure that the phlebotomist is trained in proper techniques for:

(i) Specimen collection; and

(ii) Infection control.

(b) A licensee shall provide appropriate protective clothing and disposable gloves and ensure that they are used appropriately by all personnel involved in drawing or handling blood.

(c) A phlebotomist shall wear new gloves for each examinee.

(d) A laboratory employee shall use and clean phlebotomy devices as prescribed by the manufacturer.

(8) Testing Logs. A licensee shall maintain for 2 years a log identifying all:

(a) Persons tested;

(b) Test results; and

(c) Test dates.

(9) Results Reporting. The licensee of a temporary or mobile laboratory:

(a) May give results of a health awareness test immediately following the testing directly to the individual who underwent the test; and

(b) Shall give the test results in writing stating the:

(i) Name of the individual tested,

(ii) Name of the laboratory performing the test,

(iii) Name of the test,

(iv) Date of the test, and

(v) Test result with appropriate interpretation or reference range consistent with current nationally recognized standards.

(10) Disposal of Special Medical Waste. A licensee operating a temporary or mobile laboratory shall dispose of special medical waste as required in COMAR 10.06.06.