Current through Register Vol. 51, No. 19, September 20, 2024
A. In addition to
any other applicable requirements in this chapter, an employer or agent of the
employer that performs a preliminary preemployment screening procedure for a
controlled dangerous substance on a job applicant shall meet the standards set
forth in this regulation.
B.
Registration Requirement. An employer or agent of the employer shall register
the employer initially and every 2 years thereafter with the OHCQ by:
(1) Submitting to the OHCQ a registration
form that:
(a) Lists the permanent office
location of the employer and any agent of the employer in the State;
(b) Lists the permanent locations where the
employer or agent of the employer performs preliminary screenings;
and
(c) States whether the employer
or agent of the employer performs preliminary screenings at temporary sites,
uses mobile screening vehicles, or both; and
(2) Submitting to the OHCQ a registration fee
of $50.
C. Single-Use
Test Device. An employer or agent of the employer shall limit screening
procedures to those that employ an FDA-cleared or approved single-use test
device as defined in Regulation .03B(21) of this chapter.
D. Trained Operator. To perform a preliminary
screening procedure, an employer or agent of the employer shall employ an
operator who has been trained for each type of device to be used, including
instruction that includes the operator's:
(1)
Reading the test manufacturer's package insert sheet;
(2) Observing the test manufacturer's
training video or receiving training:
(a)
From the test manufacturer;
(b)
From an individual trained by the manufacturer; or
(c) Endorsed by the manufacturer;
(3) Completing the test
manufacturer's self-administered test; and
(4) Performing tests, interpreting test
results, and reporting results to job applicants under the supervision of a
trained operator.
E.
Training Records.
(1) Requirement. An employer
or agent of the employer shall establish and maintain training records that
document the training required to properly perform a screening
procedure.
(2) Documentation. An
employer or agent of the employer shall:
(a)
Keep a record of the training received by a trainee;
(b) Document that a trainee has demonstrated
competency in performing the screening procedure; and
(c) Maintain for at least 2 years
documentation that the trainee has been trained as set forth in this
regulation.
F. Quality Assurance. An employer or agent of
the employer shall:
(1) Limit screening
procedures to those that employ an FDA-cleared or FDA-approved single-use test
device for forensic testing, as defined in Regulation .03 of this
chapter;
(2) Perform preliminary
screening tests in accordance with the quality standards set forth in COMAR
10.10.03.02C(2) and
(3);
(3) Collect and handle all specimens and ship
non-negative specimens for testing, in a manner that:
(a) Maintains the specimen donor's identity
and confidentiality; and
(b)
Precludes contamination of and tampering with the specimen;
(4) Provide a secure area with
limited access to store a non-negative specimen before it is shipped to a
laboratory and while it is retained pending:
(a) Confirmatory testing;
(b) Notice;
(c) Any independent testing; and
(d) Final disposal;
(5) Submit a non-negative specimen subjected
to a preliminary screening procedure to a licensed medical laboratory for
confirmatory testing within 24 hours of screening;
(6) Maintain a written record of the
chain-of-custody for a specimen from the time it is collected until it is no
longer needed for retesting or confirmatory testing;
(7) Have a medical review officer, as defined
in Regulation .03B(15) of this chapter, review positive test results resulting
from a confirmatory test; and
(8)
Retain for at least 1 year all records pertaining to preliminary
screening.
G. Notice and
Independent Testing. An employer or agent of the employer who receives notice
that a job applicant has tested positive for a controlled dangerous substance
shall:
(1) Provide to the job applicant the
items specified in Regulation .08A of this chapter; and
(2) Inform the job applicant of the right to
request that an independent test be performed on the same specimen, as set
forth in Regulation .08B of this chapter.
H. Voluntary Disclosure.
(1) For the purposes of facilitating hiring,
a job applicant may voluntarily disclose and provide documentation to an
operator that the job applicant is using:
(a)
A nonprescription drug that is not prohibited under the laws of the
State;
(b) A medically prescribed
drug; or
(c) Both.
(2) An operator may disclose to
the employer information involving the use of medically prescribed and
nonprohibited nonprescription drugs voluntarily disclosed and documented to the
operator by the job applicant.
I. Surveys and Complaint Investigations. An
employer or agent of an employer shall permit the OHCQ to conduct an on-site
survey of a preliminary screening site at any time during the screening site's
normal hours of operation as part of a complaint investigation or routine
inspection to determine compliance with the applicable requirements and
standards set forth in this chapter.
