10-144-265 Me. Code R. § 4

Current through 2024-51, December 18, 2024
Section 144-265-4 - TESTING LABORATORIES
A. Laboratories conducting substance use testing of employees and applicants must comply with all of the following requirements, except as noted.
1. Licensure.
a. Laboratories conducting substance use testing under this rule must be licensed by the Department for such testing. Application for licensure must be made by the laboratory owner on forms prescribed by the Department and must be accompanied by a non-refundable fee, in accordance with the Schedule of Charges for Testing and Services Provided by the Maine Health and Environmental Testing Laboratory Rule (10-144 CMR Chapter 257), as provided by 22 MRS §565.
b. A laboratory may be licensed upon application, without inspection, if the laboratory is approved by the Substance and Mental Health Services Administration's National Laboratory Certification Program or College of American Pathologists Laboratory Accreditation Program (CAP). CAP-Forensic Drug Testing Accreditation program (FDT) is not required for an applicant under this rule; however, a laboratory holding CAP-FDT certification may be licensed without inspection.
c. The term of the license will be one year from the date of issue. Application for renewal must be received by the Department at least one month before the expiration date of the current license. Application for renewal must be accompanied by a non-refundable fee, in accordance with 10-144 CMR Chapter 257, as provided by 22 MRS § 565.
d. Laboratories must notify the Department of any changes to accreditation status, within 10 days of occurrence.
B. The laboratory must designate one or more certifying officer(s), who may be the director. The certifying officer(s) must be qualified in both formal training and laboratory experience, for performance and supervision of substance use testing. A certifying officer must review the standards, blanks and quality control data together with the screening and confirmation test results. Upon assurance that all results are acceptable, the certifying officer certifies the test result or results before reporting.
C. All laboratory reports, including the screening, confirmation and quality control data must be reviewed by a certifying officer before being certified as accurate. The report must identify the name of the laboratory, the drugs and metabolites tested for, whether the test results were negative or confirmed non-negative, and the cutoff levels for each substance.
1. Unless agreed upon by the employee or applicant, no report may show the quantity of substance detected, but only the presence or absence of that substance relative to the cutoff level.
2. No report may show that a substance was detected in a screening test, unless the presence of the substance was confirmed in the confirmatory test. Procedures must be in place to ensure that an applicant or employee's unconfirmed non-negative screening test result cannot be determined by the employer in any manner, including, but not limited to, the method of billing the employer for the tests and the time within which results are provided to the employer.
3. No substance may be reported as present if the employer requesting the testing did not request analysis for that substance.
4. Reports of samples segregated at the request of the applicant or employee for testing by a laboratory selected by the applicant or employee must be provided to both the employer and the applicant or employee.
D. A laboratory aggrieved by any decision of the Department regarding approval has the rights of appeal specified in the Maine Administrative Procedure Act, 5 MRS ch. 375, and the Administrative Hearings Regulations, 10-144 CMR chapter 1.

10-144 C.M.R. ch. 265, § 4