Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.11 - Quality Assurance and Quality Control Programs

Current through June 14, 2024
A. The
				  laboratory must have a quality assurance plan that details the quality
				  assurance system of quality control requirements in its standard operating
				  procedures and document that all personnel review the quality assurance plan
				  annually. The analytical laboratory must follow all applicable quality control
				  activities described in its quality assurance plan as approved by the RIDOH.
				  Analytical laboratories must review their quality assurance plan annually and
				  provide a copy of the updated quality assurance plan to the RIDOH with the
				  annual renewal application.
B. Each
				  laboratory must have clearly established internal and external quality controls
				  to ensure high standards of performance and reliability of test results. These
				  quality controls must consider such factors as preventative maintenance,
				  periodic inspection, testing for proper validation of methods, evaluation of
				  reagents and volumetric equipment, surveillance of results, remedial action
				  taken to correct deficiencies and quality control failures and other factors as
				  may be deemed necessary.
C. The
				  laboratory must perform all analyses using methods that are currently approved
				  by the RIDOH, as described in §
										6.21   of this Part.
D. The laboratory's quality assurance plan
				  must be accessible to all personnel in the laboratory. It must include, but not
				  be limited to:
1. Laboratory sampling plan for
				  collecting representative samples of finished cannabis products;
2. Laboratory sample handling
				  procedures;
3. Emergency sampling
				  and handling plan;
4. Laboratory
				  glassware, plastic ware and equipment washing and sterilizing
				  procedures;
5. Instrument
				  calibration procedures;
6. A list
				  of detailed analytical procedures or analytical references;
7. Data reduction, validation, and reporting
				  procedures including non-compliance action plan;
8. Types and frequency of internal audit
				  samples (quality control samples) and external audit samples (proficiency
				  testing samples);
9. Internal audit
				  procedures and frequency;
10.
				  Preventative maintenance procedures and schedules;
11. Procedures for determining accuracy and
				  precision and method detection limits of all analytes and specified
				  frequency;
12. Control limits and
				  corrective action policies;
13.
				  Laboratory organization, staff, and responsibilities;
14. Procedures for laboratory and managerial
				  data review;
15. Detection limits
				  (DL) for cannabinoids, and contaminant analytes specified in these regulations
				  must be determined by DL studies prior to placing new methods in service and
				  annually thereafter. The resulting detection limits must be less than half of
				  the Upper Limit concentration criteria specified in these regulations. If the
				  laboratory cannot meet a DL that is less than half of the Upper Limit for an
				  analyte, a request for a variance must be submitted;
16. The applicable quality control procedures
				  required for methodologies described by the FDA, AOAC, AHP or USP.