Md. Code Regs. 10.10.10.10

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.10.10 - Preliminary Screening by an Employer or Agent of the Employer

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.

Md. Code Regs. 10.10.10.10

Regulation .10 adopted effective February 18, 2002 (29:3 Md. R. 220)
Regulation .10F amended effective July 22, 2002 (29:14 Md. R. 1074)