37.107.302 MARIJUANA TESTING LABORATORY GENERAL REQUIREMENTS
(1) A licensed marijuana testing laboratory must employ a full-time scientific director that meets the minimum requirements described in 50-46-311, MCA.
(2) The scientific director must ensure that:
(a) the laboratory achieves and maintains ISO/IEC 17025:2017 accreditation for all testing methods/analytes required in ARM 37.107.316;
(b) the laboratory's processes and practices are compliant with ISO/IEC 17025:2017 standards;
(c) the laboratory maintains quality practices in the pre-analytic, analytic, and post-analytic phases of testing;
(d) testing personnel have been appropriately trained and demonstrate competency prior to providing testing services;
(e) policies and procedures are in place for monitoring personnel competence;
(f) approved standard operating procedures are in place, have been reviewed, and are followed by all testing personnel;
(g) appropriate test methods are in place;
(h) test method validations have been performed to determine the accuracy, precision, and limitations of methods;
(i) acceptable analytical test performance is established and maintained for each test system;
(j) quality assurance and quality control programs are established and maintained;
(k) remedial actions are taken and documented when significant deviations from the laboratory's established performance characteristics are identified and test results are reported only when test systems are functioning properly;
(l) the laboratory successfully participates in an approved proficiency testing (PT) program(s), as described in this subchapter, for all methods/analytes required in ARM 37.107.316;
(m) the physical and environmental conditions of the laboratory are adequate and appropriate for the testing performed; and
(n) the environment for employees is safe from physical, chemical, and biological hazards, and safety and biohazard requirements are followed.
(3) A scientific director must be physically present at the laboratory for the majority of time that testing is performed in order to adequately carry out their responsibilities.
(4) A licensed marijuana testing laboratory must be able to perform at least 75% of the quality assurance testing requirements defined in ARM 37.107.316.
(5) A licensed marijuana testing laboratory can only refer quality assurance testing to another licensed marijuana testing laboratory in Montana which has met the requirements of this subchapter, and the referred testing laboratory must be identified in all testing reports, the certificates of analysis and in METRC.
(6) A licensed marijuana testing laboratory must obtain written permission from the test batch sample's provider prior to sending the provider's test batch sample to another licensed marijuana laboratory in Montana or return the product to the provider at their request.
(7) A licensed marijuana testing laboratory may:
(a) obtain samples of marijuana items from providers, registered cardholders, or other licensees for testing as provided in this subchapter;
(b) transport and dispose of samples as provided in this subchapter; and
(c) perform testing on marijuana items in a manner consistent with the laboratory's accreditation.
(8) A licensed laboratory may return a marijuana item obtained for purposes of testing to the provider. The return of such marijuana items must be documented in METRC.
(9) A licensed laboratory must document the following:
(a) receipt of samples for testing;
(b) size, weight, or quantity of the sample;
(c) provider from whom the sample was obtained;
(d) date the sample was collected, and who collected it;
(e) tests performed on samples;
(f) date(s) testing was performed;
(g) results of all testing performed;
(h) certification of all testing performed and corresponding results in a certificate of analysis; and
(i) disposition of any remaining test sample material.
(10) A laboratory licensee must clearly identify all limited access areas at the premises.
(11) All laboratory licensee employees must wear a department-issued identification badge.
(12) A laboratory licensee must maintain a daily log of all visitor activity at a registered premise. The log must contain:
(a) visitor first and last name;
(b) the date;
(c) arrival and departure times;
(d) visitor affiliation; and
(e) purpose of visit.
(13) Visitors must be accompanied by a laboratory licensee employee at all times.
(14) A laboratory licensee is responsible for the security of all marijuana items on the premises, in transit, and under the supervision of the licensee or licensee employee.
(15) A laboratory licensee must have a written security plan maintained on the premises that safeguards against theft, diversion, corruption, or tampering of quality assurance samples, and corresponding data/reports both on the premises, during transit, and storage.
(16) Commercial grade locks must be installed on every external door or gate of the laboratory, if applicable, as well as storage or transfer stations.
(17) A laboratory licensee must ensure general sanitary requirements are met on the premises to include:
(a) hand-washing facilities;
(b) proper and timely removal of all litter and waste; and
(c) toilet facilities that are maintained in a sanitary condition and good repair.
(18) A laboratory licensee must maintain the following records/data for at least three years:
(a) financial records that clearly reflect all financial transactions;
(b) testing data and reports to include quality control (QC) data, standard curves, raw instrument data, calculations, spreadsheets, certificates of analysis, provider reports, etc.; and
(c) all laboratory licensee employee training and payroll records.
(19) Records/data may be kept in either paper or electronic form on the premises and must be readily available for quality assurance and audit purposes.
(20) A laboratory licensee must establish written emergency procedures to be followed in case of a fire, chemical spill, or other emergency at all premises.
(21) A laboratory licensee must provide and maintain, at its own expense, analytical testing laboratory professional liability insurance with an aggregate limit of one million dollars prior to the issuance of a license.
(22) A laboratory licensee must obtain and maintain a $25,000 surety bond which names the department as loss payee in the event the laboratory licensee fails to adhere to the security plan approved by the department, or it otherwise operates the facility in a manner that allows for, or results in theft, loss, or diversion of marijuana items. A copy of the bond must be submitted to the department prior to a license being issued.
History: 50-46-344, MCA; IMP, 50-46-303, 50-46-304, 50-46-311, 50-46-312, 50-46-326, 50-46-329, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.