Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.06 - Medical Laboratories-Quality Assurance
Section 10.10.06.08 - Quality Control - Job-Related Alcohol and Drug Testing
Universal Citation: MD Code Reg 10.10.06.08
Current through Register Vol. 51, No. 19, September 20, 2024
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 10.10.02.02B.
(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 10.10.10.06B.
(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
10.10.05.03B of
this subtitle.
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
