CMTL On-Site Inspection

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64ER20-4CMTL On-Site Inspection

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 64ER20-4 addresses on-site inspections 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:

 

64ER20-4 CMTL On-Site Inspection

(1) The department may conduct random and unannounced inspections of any CMTL Testing Facility, vehicle utilized by a CMTL, or facility where CMTL records are kept. A CMTL’s refusal to allow entry or inspection is grounds for disciplinary action pursuant to CMTL rules.

(2) A CMTL must maintain at its Testing Facility all records necessary to substantiate its compliance with sections 381.986 and 381.988, F.S., CMTL rules, and the specific representations in the CMTL’s application for certification. The CMTL must make such records available to the department for review during any inspection.

(3) A CMTL must allow department personnel complete, immediate, and unrestricted access to enter, inspect, monitor, and observe all areas and operations of a CMTL’s Testing Facility, vehicles, and all areas where CMTL records are kept. CMTLs must allow department personnel to examine records, view surveillance videos, interview Employees, and observe the CMTL's testing facilities, procedures, and equipment. CMTL personnel must cooperate with the department’s inspection and provide responses to inquiries.

(4) During any inspection, a CMTL must demonstrate its compliance with sections 381.986 and 381.988, F.S., CMTL rules, and the specific representations in the CMTL’s application.

(5) If during any inspection the department identifies any deficiencies or violations of sections 381.986 or 381.988, F.S., CMTL rules, or the specific representations of the CMTL’s application, the department will send written notice to the CMTL identifying the deficiencies or violations. Within fourteen (14) calendar days of receipt of a written notice of a deficiency or violation, the CMTL must provide the department a written corrective action plan to resolve the deficiency or violation via email to [e-mail]. The corrective action plan must include, at a minimum, the action steps the CMTL intends to take to resolve the deficiency or violation, the specific deadline for each step, and the additional steps the CMTL intends to take to prevent future deficiencies or violations. The department will determine whether the corrective action plan is appropriate to resolve the deficiency or violation, whether any additional action must be taken by the CMTL, and whether disciplinary action against the CMTL is appropriate. Notwithstanding corrective action taken by a CMTL, the department may take disciplinary action against the CMTL in accordance with CMTL rules.

(6) A CMTL is subject to additional inspections by the department to confirm that the deficiency or violation has been resolved and that the corrective action plan has been implemented.

(7) A CMTL’s failure to resolve any deficiency or violation identified during an inspection in the time period required by the department or specified in a corrective action plan is grounds for disciplinary action in accordance with CMTL rules.

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