CMTL Calibration Standards  

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    DEPARTMENT OF HEALTH

    RULE NO.:RULE TITLE:

    64ER20-11CMTL Calibration Standards

    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 64ER20-11 addresses calibration standards that CMTLs must adhere to and requirements for providing any alternative methods to the department.

    THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Courtney Coppola at Courtney.Coppola@flhealth.gov.

     

    THE FULL TEXT OF THE EMERGENCY RULE IS:

     

    64ER20-11 CMTL Calibration Standards

    (1) CMTLs must prepare Calibration Standards pursuant to and in compliance with this rule. Calibration Standards must be prepared by diluting Certified Reference Materials to produce working standards to be used in the Calibration of instruments, the quantitation of analysis samples, and for use in Laboratory Fortified Blanks and Matrix Spike Samples. Certified Reference Materials must be:

    (a) Obtained from an independent body that holds ISO/IEC 17034:2017 accreditation; or

    (b) Created by the CMTL, if the CMTL holds ISO/IEC 17034:2017 accreditation.

    (2) The Limit of Detection (LOD) must be calculated for Mycotoxins, Heavy Metals, Residual Solvents, Agricultural Agents, and Cannabinoid Profile in one of the following ways:

    (a) The signal-to-noise ratio, as calculated by comparing the measured signals of known Target Analyte concentrations with those within the Method Blanks to establish the minimum concentration a Target Analyte can be consistently detected. Acceptable ratios must be within the range of 3:1 to 2:1;

    (b) Based on the standard deviation of the instrument’s response and the slope of the Calibration Curve, calculated as 3.3 × the standard deviation of the response ÷ the slope of the Calibration Curve. The standard deviation of the response must be determined by comparing seven Method Blank samples. The Limit of Detection for chemical methods must be less than 1/10 of the action level for each Target Analyte; or

    (c) Any other method published by the U.S. Food and Drug Administration or the U.S. Environmental Protection Agency. A CMTL utilizing a method pursuant to this paragraph must provide the method to the department via email to OMMUlabs@flhealth.gov.

    (3) The Limit of Quantitation (LOQ) must be calculated for Mycotoxins, Heavy Metals, Residual Solvents, Agricultural Agents, and Cannabinoid Profile in one of the following ways:

    (a) The signal-to-noise ratio, as calculated by comparing the measured signals of known Target Analyte concentrations with those of Method Blanks to establish the minimum concentration a Target Analyte can be consistently detected. The minimum acceptable ratio is 10:1;

    (b) Based on the standard deviation of the instrument’s response and the slope of the Calibration Curve, calculated as 10 × the standard deviation of the response ÷ the slope of the Calibration Curve. Standard deviation of the response is determined by comparing seven Method Blank samples. The LOQ for chemical methods must be, at a maximum, ½ of the Target Analyte’s Acceptable Limit; or

    (c) Any other method published by the U.S. Food and Drug Administration or the U.S. Environmental Protection Agency. A CMTL utilizing a method pursuant to this paragraph must provide the method to the department via email to OMMUlabs@flhealth.gov.

    (4) The correlation coefficient of the Calibration Standard regression model must be greater than or equal to 0.98. A Calibration Curve must consist of a minimum of five (5) consecutive points if utilizing a linear correlation, and a minimum of six (6) consecutive points of utilizing a non-linear correlation. The Calibration Curve must, at a minimum, span from the Limit of Quantitation to the Acceptable Limit for each individual Target Analyte.

    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 22, 2020

Document Information

Effective Date:
1/22/2020
Subject:
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 64ER20-11 addresses calibration standards that CMTLs must adhere to and requirements for providing any alternative methods to the department.
Purpose:
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.
Contact:
Courtney Coppola at Courtney.Coppola@flhealth.gov.