Sec. 10.10.06.08. Quality Control — Job-Related Alcohol and Drug Testing

A. Primary Standard. A licensee shall ensure that a laboratory has in place a quality assurance program designed to monitor and evaluate all phases of the testing process including but not limited to:

(1) Laboratory certification;

(2) Specimens, specimen collection, chain of custody, and transport;

(3) Security and controlled access;

(4) Storage and specimen retention;

(5) Analytical methods and procedures;

(6) Accuracy, precision, and reliability;

(7) Single-use test devices;

(8) Reporting test results; and

(9) Proficiency testing.

B. Standards.

(1) Certification. A licensee of a laboratory that offers to perform or performs screening or confirmation tests for alcohol or controlled dangerous substances shall ensure that the laboratory is inspected and certified to perform tests for alcohol or controlled dangerous substances by:

(a) The Secretary;

(b) The College of American Pathologists;

(c) The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or

(d) A government agency, program, or accrediting organization approved by the Secretary as set forth in COMAR 10.10.02.02.

(2) Specimens, Specimen Collection, Chain of Custody, and Transport.

(a) Permissible Specimens. A licensee shall ensure that job-related tests for alcohol or controlled dangerous substances are only performed using specimens derived from the human body as set forth in COMAR 10.10.10.06.

(b) A licensee shall ensure that a specimen is processed, handled, and transported in a manner that protects the identity and physical integrity of the specimen by:

(i) Accepting a specimen in a sealed container that has a non-resealable closure or an evidentiary tape that assures detection of any tampering; and

(ii) Implementing, maintaining, and employing chain of custody procedures, including documentation of specimen handling and access, that cover the life of a specimen from the time of collection through final disposal of the specimen.

(c) Decontamination Requirement for Hair Specimens. A licensee shall ensure that the laboratory establishes, validates, and uses a procedure to remove possible external contamination from a hair specimen before a test is performed.

(3) Security and Controlled Access. A licensee shall ensure that a specimen is collected and processed in a manner that protects the physical integrity of the specimen by:

(a) Collecting and processing a specimen under supervised conditions;

(b) Securing the laboratory or any portion of the laboratory used for job-related alcohol or controlled dangerous substances testing;

(c) Using and maintaining secure specimen storage areas that include, when applicable, locked freezers and refrigerators;

(d) Limiting access to testing and specimen storage facilities to authorized personnel;

(e) Exercising and maintaining control over a specimen storage area by documenting in an access log the identity, date, time of entry and exit, and the purpose for entry for each individual who enters the storage area; and

(f) Recording, reporting, and maintaining a test result in a manner that prevents alteration and breech of confidentiality by:

(i) Limiting access to a test result to authorized personnel; and

(ii) Preparing and storing a test result in a secured area.

(4) Storage and Specimen Retention. A licensee shall ensure that a:

(a) Positive urine or hair specimen is retained in the original collection container for at least 6 months after a final test result is reported;

(b) Positive urine or blood specimen is stored at less than or equal to -20° Centigrade; and

(c) Negative specimen is retained for at least 5 days at less than or equal to room temperature.

(5) Analytical Methods and Procedures. A licensee shall ensure that tests are performed using proven and reliable methods and procedures that are approved by the:

(a) Secretary;

(b) College of American Pathologists (CAP);

(c) The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or

(d) United States Food and Drug Administration (FDA).

(6) Approval of Methods and Procedures. The Secretary shall base approval or acceptability of any analytical method or procedure with questioned validity or reliability on evidence published in a peer-reviewed scientific journal and derived from independent:

(a) Scientific testing and evaluation; or

(b) Scientifically based clinical trial.

(7) Accuracy, Precision, and Reliability. The licensee shall ensure that the laboratory employs quality control mechanisms and practices, including but not limited to those assuring accuracy, precision, and reliability of test results by:

(a) Using a sufficient number of reference standard samples with each batch of test specimens to ensure accuracy of the assay or procedure's linearity over time;

(b) Using reference standard samples that have values at or near the minimum drug detection levels or concentrations;

(c) Using results obtained from testing reference standard samples to document linearity and calculate test data obtained from test specimens;

(d) Including in each analytical run quality control samples that are:

(i) Certified to contain no alcohol or controlled dangerous substance;

(ii) Fortified with known reference standards;

(iii) Positive with the alcohol or controlled dangerous substance at or near the cutoff or minimum detection level; and

(iv) Using a total number of quality control samples in an analytical run equal to at least 5 percent of the number of specimens being tested;

(e) Verifying and documenting at least monthly the linearity and precision of each test method and procedure; and

(f) Using methods, procedures, and techniques that prevent samples and specimens from contaminating one another throughout the testing process.

(8) Cutoff Levels.

(a) A licensee that offers to perform or performs job-related alcohol or controlled dangerous substances testing shall use the established cutoff levels specified in §B(8)(b) and (c) of this regulation to distinguish a positive from a negative test specimen.

(b) Urine. A laboratory testing urine shall use the cutoff levels set forth in 49 CFR §40.87.

(c) Blood, Saliva, and Hair.

(i) A licensee testing blood, saliva, or hair specimens shall use the cutoff levels established by an agency of the federal government for the purpose of determining whether a specimen is positive or negative for alcohol or a controlled dangerous substance.

(ii) If cutoff levels in blood, saliva, or hair have not been established and accepted by an agency of the federal government, a licensee shall establish and use a cutoff level for each screening test and confirmatory test performed to determine whether a specimen is negative for each controlled dangerous substance that the licensee offers to detect by a screening or confirmatory procedure.

(d) Validation. A licensee shall ensure that the:

(i) Laboratory maintains documented data validating each cutoff level; and

(ii) Cutoff data is made available for review by the OHCQ.

(9) Single-Use Test Devices. A laboratory that performs screening tests using single-use test devices, as defined in COMAR 10.10.01.03B, may meet the quality assurance and quality control standards set forth in Regulation .06 of this chapter instead of the standards set forth at §B(1) of this regulation.

(10) Reporting Test Results. A licensee shall ensure that a job-related laboratory test report includes:

(a) A list of all the drug and alcohol tests that were performed on the specimen;

(b) Positive test results only if the specimen was found positive by a confirmation test that employed a combination of:

(i) Gas chromatography and mass spectrometry (GC/MS);

(ii) Mass spectrometry and mass spectrometry (MS/MS);

(iii) Gas chromatography tandem mass spectrometry (GC/MS/MS); or

(iv) Other analytical methods that use mass spectrometry as the primary detection technique;

(c) The value at the cutoff or detection level of each test, that is, screening test or confirmation test, or both, for alcohol or a controlled dangerous substance performed on the specimen;

(d) The telephone number of the laboratory that may be used by an employer or individual who was tested to obtain technical assistance for the purpose of interpreting a positive test result; and

(e) Except as provided in Health-General Article, §17-214(i), Annotated Code of Maryland, no information to an employer or prospective employer on:

(i) The use of a nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or

(ii) The use of a legally prescribed drug, unless the individual tested is unable to establish that the drug was prescribed in accordance with the laws of the State.

(11) Proficiency Testing. A licensee shall ensure that the laboratory enrolls and continues to participate satisfactorily in a proficiency testing program that:

(a) Covers each type of job-related alcohol and controlled dangerous substance test specimen analyzed; and

(b) Has the approval of the Secretary as set forth in COMAR 10.10.05.03 of this subtitle.