Sec. 10.10.06.03. Patient Test Management

A. Primary Standard. A licensee shall ensure that the laboratory:

(1) Provides patient manipulation by qualified personnel; and

(2) Employs and maintains a quality assurance program that provides for:

(a) Proper patient preparation;

(b) Proper specimen:

(i) Collection;

(ii) Identification;

(iii) Preservation;

(iv) Transportation; and

(v) Processing;

(c) Record maintenance; and

(d) Accurate reporting of results.

B. Standard - Patient Manipulation and Specimen Collection.

(1) A person may not manipulate a patient, for example, to collect specimens unless the person is:

(a) A licensed:

(i) Physician; or

(ii) Nurse;

(b) Authorized by law to:

(i) Collect a specimen from an individual for medical laboratory testing; or

(ii) Manipulate a patient; or

(c) Employed by a licensee under this title.

(2) A licensee shall ensure that specimens for laboratory testing are collected by individuals who are trained in and have documented experience in:

(a) Preparing patients for specimen collection; and

(b) Collecting the appropriate specimen required for the requested test.

(3) Qualified personnel authorized by the licensee may collect:

(a) Blood specimens, including:

(i) Venipuncture; and

(ii) Finger or heel stick whole-blood specimens;

(b) Stomach contents; and

(c) Clinical materials for smears and culture, for example, throat and nasopharyngeal swabs, and other specimens required to perform a requested test under the direction or on the written request of a physician or other person authorized by law and identified in Regulation .02 of this chapter.

(4) An employer may collect a specimen for job-related testing to determine use or abuse of a controlled dangerous substance or alcohol as set forth under COMAR 10.10.10.

(5) A person collecting specimens for medical laboratory testing or examination shall follow the licensee's policies and procedures contained in the laboratory's quality assurance system as set forth in §C of this regulation.

(6) This section does not apply to the collection of a DNA specimen with a buccal swab used for determining paternity.

C. Standard - Quality Assurance. A licensee shall ensure that the laboratory's quality assurance system:

(1) Provides optimum patient test results by establishing and maintaining mechanisms to preserve specimen integrity and maintain positive specimen identification throughout the entire testing process, including the:

(a) Preanalytic phase;

(b) Analytic phase; and

(c) Postanalytic phase; and

(2) Meets the applicable standards contained in 42 CFR §§493.1230 -493.1234, 493.1240-493.1249, and 493.1281-493.1299.