Standard Operating Procedures

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64ER20-6Standard Operating Procedures

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: Pursuant to Chapter 2019-116, § 41, at 31, Laws of Florida, the Department is not required to make findings of an immediate danger to the public, health, safety, or welfare.

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The Department of Health is directed by Chapter 2019-116, § 41, at 31, Laws of Florida, to adopt emergency rules to implement section 381.988, Florida Statutes

SUMMARY: Emergency rule 64ER20-6 addresses required Standard Operating Procedures of a Certified Marijuana Testing Laboratory (CMTL).

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Courtney Coppola at [e-mail].

 

THE FULL TEXT OF THE EMERGENCY RULE IS:

 

64ER20-6 Standard Operating Procedures

(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 rule 64ER20-2, F.A.C.

(2) A CMTL must create and maintain Standard Operating Procedures for the Target Analytes and materials within rule 64ER20-9, F.A.C., as well as the following testing functions and responsibilities:

(a) Identification, Calibration, and maintenance of equipment and instruments;

(b) Chain of custody protocols;

(c) Data review and internal review processes;

(d) Sample preparation methods;

(e) Analytical Methods;

(f) Cleaning procedures for equipment, workspaces, and Secure Storage;

(g) Contingency plans for data that is not within the parameters set in rules 64ER20-10 and 64ER20-11, F.A.C., or is otherwise unacceptable for analysis;

(h) Employee training;

(i) Premises and sample security;

(j) Proficiency Testing instructions provided with Proficiency Testing samples;

(k) Quality Assurance and Quality Control procedures;

(l) Recordkeeping and record retention;

(m) Sample collection;

(n) Sample preparation;

(o) Sample identification;

(p) Sample transportation;

(q) Sample rejection;

(r) Sample destruction;

(s) Sample disposal;

(t) Disposal of non-marijuana waste;

(u) Sample Secure Storage;

(v) Schedule and process for internal audits and corrective actions; and

(w) Disposal of marijuana and hazardous waste.

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

(a) The name of the Analytical Method;

(b) A list of all Target Analytes tested for using the Analytical Method;

(c) The applicable Matrix or Matrices;

(d) Method sensitivity;

(e) Common potential interferences;

(f) The equipment and instruments used;

(g) Consumable supplies and Calibration Standards;

(h) Sample collection, preservation and hold time;

(i) Type, frequency, and acceptable criteria for Quality Control samples;

(j) Type, frequency, and acceptable criteria for Calibration Standards;

(k) Procedures for analyzing Analytical Batch samples;

(l) Data Quality Control and acceptance criteria;

(m) Calibration of results;

(n) Reagent and Certified Reference Material preparation;

(o) References; and

(p) Dates of authorized changes.

(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) 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.

 

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.

EFFECTIVE DATE: January 21, 2020