1. (1) CMTLs must develop, maintain, and implement testing methods and a corresponding written Quality Assurance Manual in conformity with this rule and any required accreditation pursuant to Rule 64-4.301, F.A.C.

2. (2) A CMTL must create and maintain SOPs compliant with s. 381.988, F.S., and department rules that address 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) Sample preparation method development and validation;
   6. (f) Analytical Methods;
   7. (g) Analytical Method development and validation;
   8. (h) Chromatographic peak identification and integration;
   9. (i) Data Reduction;
   10. (j) Cleaning procedures for equipment, workspaces, and Secure Storage;
   11. (k) Balance and pipette verification, calibration, and maintenance;
   12. (l) Temperature calibration and monitoring;
   13. (m) Contingency plans for data that are not within the parameters set forth in Rules 64-4.309 and 64-4.310, F.A.C., or are otherwise unacceptable for analysis;
   14. (n) Employee training;
   15. (o) IDOC;
   16. (p) Premises and sample security;
   17. (q) Proficiency Testing instructions provided with Proficiency Testing samples;
   18. (r) Quality Assurance and Quality Control procedures;
   19. (s) LOD and LOQ determination;

   20. (t) Quality Control and Quality Assurance standard preparation and documentation, to include the creation of:

       1. Calibration Standards;

       2. Spike Solutions;

       3. ICV solutions;

       4. CCV solutions; and

       5. Internal Standards solution.

   21. (u) Recordkeeping and record retention;
   22. (v) Sample collection;
   23. (w) Sample preparation;
   24. (x) Sample homogenization;
   25. (y) Sample identification;
   26. (z) Sample transportation;
   27. (aa) Sample rejection;
   28. (bb) Sample destruction;
   29. (cc) Sample disposal;
   30. (dd) Disposal of non-marijuana waste;
   31. (ee) Sample Secure Storage;
   32. (ff) Schedule and process for internal audits and corrective actions;
   33. (gg) Disposal of Marijuana Waste; and
   34. (hh) Disposal of hazardous waste.

3. (3) A CMTL’s SOP for Analytical Methods as required by paragraph (2)(f) must include:

   1. (a) The name of the Analytical Method;
   2. (b) Definitions of terms and acronyms used therein;
   3. (c) A list of all Target Analytes tested for using the Analytical Method;
   4. (d) LODs and LOQs of all Target Analytes in Matrix and on column;
   5. (e) The applicable Matrix or Matrices;
   6. (f) Method sensitivity;
   7. (g) Common potential interferences;
   8. (h) The equipment and instruments used;
   9. (i) Consumable supplies and Calibration Standards;
   10. (j) Sample collection, preservation and hold time;
   11. (k) Type, frequency, and acceptable criteria for Quality Control samples;
   12. (l) Type, frequency, and acceptable criteria for Calibration Standards;
   13. (m) Procedures for analyzing Analytical Batch samples;
   14. (n) Data Quality Control and acceptance criteria;
   15. (o) Calibration of results;
   16. (p) Reagent and Certified Reference Material preparation;
   17. (q) Reference method the SOP is based on; and
   18. (r) Dates and narrative of authorized changes.
4. (4) Laboratory Directors must review, approve, sign, and date each SOP and each revision to an SOP. All SOPs must include issue dates and revision dates.
5. (5) The latest revised SOP must be kept on Testing Facility premises and be accessible to all Employees during all hours of operation.
6. (6) Upon request by the department, a CMTL must provide the department with a current copy of the CMTL’s SOPs to substantiate compliance with ss. 381.986 and 381.988, F.S., and department rules, within 48 hours of the request. A CMTL must submit responses to the department’s requests for the CMTL’s SOPs electronically by email to ommulabs@flhealth.gov or the department’s licensing portal at https://fldohommu.force.com/cmtl. A CMTL may not submit physical copies of documents and records to the department for the purpose of responding to such a request. Failure to provide the department with a current copy of the CMTL’s SOPs in a timely manner may be grounds for disciplinary action in accordance with s. 381.988(8), F.S., and Rule 64-4.315, F.A.C.

Rulemaking Authority Art. X, § 29, Fla. Const., 381.988(3), 381.988(9) FS. Law Implemented Art. X, § 29, Fla. Const., 381.988 FS. History–New 5-28-26.