1. (1) CMTLs must develop, maintain, and implement testing methods and corresponding written quality documentation in conformity with this rule and any required accreditation pursuant to Emergency Rule 64ER20-2, F.A.C.

2. (2) A CMTL must create and maintain Standard Operating Procedures for the Target Analytes and materials within r Emergency Rule 64ER20-2, F.A.C., as well as the following testing functions and responsibilities:

   1. (a) Identification, Calibration, and maintenance of equipment and instruments;
   2. (b) Chain of custody protocols;
   3. (c) Data review and internal review processes;
   4. (d) Sample preparation methods;
   5. (e) Analytical Methods;
   6. (f) Cleaning procedures for equipment, workspaces, and Secure Storage;
   7. (g) Contingency plans for data that is not within the parameters set in Emergency Rules 64ER20-10 and 64ER20-11, F.A.C., or is otherwise unacceptable for analysis;
   8. (h) Employee training;
   9. (i) Premises and sample security;
   10. (j) Proficiency Testing instructions provided with Proficiency Testing samples;
   11. (k) Quality Assurance and Quality Control procedures;
   12. (l) Recordkeeping and record retention;
   13. (m) Sample collection;
   14. (n) Sample preparation;
   15. (o) Sample identification;
   16. (p) Sample transportation;
   17. (q) Sample rejection;
   18. (r) Sample destruction;
   19. (s) Sample disposal;
   20. (t) Disposal of non-marijuana waste;
   21. (u) Sample Secure Storage;
   22. (v) Schedule and process for internal audits and corrective actions; and
   23. (w) Disposal of marijuana and hazardous waste.

3. (3) A CMTL’s Standard Operating Procedures for Analytical Methods must include:

   1. (a) The name of the Analytical Method;
   2. (b) A list of all Target Analytes tested for using the Analytical Method;
   3. (c) The applicable Matrix or Matrices;
   4. (d) Method sensitivity;
   5. (e) Common potential interferences;
   6. (f) The equipment and instruments used;
   7. (g) Consumable supplies and Calibration Standards;
   8. (h) Sample collection, preservation and hold time;
   9. (i) Type, frequency, and acceptable criteria for Quality Control samples;
   10. (j) Type, frequency, and acceptable criteria for Calibration Standards;
   11. (k) Procedures for analyzing Analytical Batch samples;
   12. (l) Data Quality Control and acceptance criteria;
   13. (m) Calibration of results;
   14. (n) Reagent and Certified Reference Material preparation;
   15. (o) References; and
   16. (p) Dates of authorized changes.
4. (4) Laboratory Directors must review, approve, sign, and date each Standard Operating Procedure and each revision to a Standard Operating Procedure. All Standard Operating Procedures must include the dates of issue and dates of revision.

5. (5) The latest revised Standard Operating Procedures must be kept on Testing Facility premises and be accessible to all Employees during all hours of operation.

   

   

   

   

Rulemaking Authority 381.988(3), 381.988(9) FS. Law Implemented 381.988 FS. History-New 1-21-20.