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Florida Administrative Code
Department 64 - DEPARTMENT OF HEALTHDivision 64 - Departmental
Chapter 64ER22 - EMERGENCY RULE FOR YEAR 2022
Section 64ER22-5 - CMTL Fines, Suspension, and Revocation

Fla. Admin. Code R. 64ER22-5

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Current through Reg. 50, No. 235-239, December 10, 2024
Section 64ER22-5 - CMTL Fines, Suspension, and Revocation
(1) Pursuant to s. 381.988, F.S., the department provides within this rule disciplinary guidelines that will be imposed upon CMTLs. The purpose of these disciplinary guidelines is to outline penalties for violations; to deter future violations; and to offer opportunities for correction, when appropriate.
(2) Once certified by the department, a CMTL must at all times maintain compliance with the requirements set forth in s. 381.986, F.S., s. 381.988, F.S., CMTL rules, and the representations made in the CMTL's application for certification. Failure to do so will result in disciplinary action in accordance this rule.
(3) The department may suspend or revoke a CMTL's certification, or refuse to renew a CMTL's certification, if the department finds that the CMTL committed a violation of s. 381.986, F.S., s. 381.988, F.S., or department rules, or that the CMTL failed to maintain compliance with the representations made in its initial application or renewal application. For any such violation, the department may revoke or suspend a CMTL's certification for a period of time based on the seriousness of the violation. The department will use the factors set forth in s. 381.988(8)(a)-(d), F.S., to determine whether to suspend or revoke a CMTL license. In determining the severity of the violation, the department will consider the following:
(a) Frequency or number of occurrences;
(b) Potential for rehabilitation;
(c) Impact on the department;
(d) Impact on MMTCs;
(e) Potential and/or actual harm to a qualified patient or a member of the public;
(f) Willfulness and deliberateness of the violation;
(g) Severity of noncompliance;
(h) Length of noncompliance; and
(i) Any good faith effort to prevent a violation.
(4) The department will provide a CMTL notice of the violation. A CMTL must provide a proposed corrective action plan to the department within seven calendar days of receipt of a notice of violation. The department may extend the timeframe for submittal of a corrective action plan for good cause shown. Upon review of the corrective action plan by the department, the CMTL may be required to take specific additional actions to cure the violation. The CMTL must comply with and perform all such additional curative actions as directed by the department. A CMTL is subject to discipline notwithstanding the implementation of a corrective action plan.
(5) A CMTL that loses or has its required accreditation suspended must report the loss or suspension within 24 hours of its occurrence to the department via email to OMMUlabs@flhealth.gov.
(a) Within seven calendar days of receiving notice that its required accreditation has been lost or suspended, a CMTL must provide the following to the department:
1. Documentation identifying the cause of the suspension or loss of accreditation; and
2. Documentation evidencing that notification of the loss or suspension has been provided to each MMTC for which the CMTL conducts testing.
(b) A CMTL is prohibited from testing marijuana product or providing results to an MMTC during the time that its accreditation is lost or suspended.
(c) A CMTL must reestablish accreditation within 180 days of the effective date of the loss or suspension of accreditation. If a CMTL fails to reestablish its accreditation within 180 days of the loss or suspension, the CMTL's certification will be subject to revocation.
(6) The department may, in addition to or in lieu of suspension or revocation, impose a fine of up to $10,000 per violation, as set forth in the schedule provided in subsection (11). The schedule of fines is meant to serve as a guideline. The maximum fines listed in the schedule reflect the maximum fines that the department may impose per violation. Where there are multiple incidents resulting in more than one violation of the same provision, the department may impose a fine, up to the maximum, for each violation. For violations that are ongoing and continuous in nature, each day a violation continues constitutes a distinct violation.
(7) The department will use the factors set forth in s. 381.988 (8)(a)-(d), F.S., to determine what discipline will be imposed. The department will also consider the following in determining the amount of the fine to be imposed:
(a) Frequency or number of occurrences;
(b) Potential for rehabilitation;
(c) Impact on the department;
(d) Impact on the MMTCs;
(e) Potential and/or actual harm to a qualified patient or a member of the public;
(f) Willfulness and deliberateness of the violation;
(g) Severity of noncompliance;
(h) Length of noncompliance;
(i) Any good faith effort to prevent a violation; and
(j) Any corrective action taken by the CMTL related to the current violation or prior violations.
(8) The issuance of a suspension under this part does not relieve the CMTL of the obligation to timely comply with all license renewal requirements. A license suspension does not toll the CMTL's license renewal deadline.
(9) No CMTL whose license has been revoked may apply for licensure under section 381.988, F.S., and chapter 64-4, F.A.C., for at least five years from the date of such revocation. However, if a CMTL's violation of statute or rule is a substantial contributing factor to the death of a patient, the CMTL will be permanently barred from applying for licensure.
(10) If a CMTL's license is suspended or revoked, no part of any application fee or renewal fee will be returned.
(11) For the purposes of the following schedule of fines, the descriptions of the violations are abbreviated, and the full statute or rule may be found by referring to the statutory or rule provision cited.

VIOLATION

MINIMUM FINE PER VIOLATION

MAXIMUM FINE PER VIOLATION

(a)

Failing to retain copies of all marijuana transportation manifests for at least three years.

(Section 381.986(8)(g)1.g.(III), F.S.)

$1,000

$2,000

(b)

Employing a qualified physician.

(Section 381.986(3)(b), F.S.)

$500

$1,000

(c)

Granting a direct or indirect economic interest to a qualified physician.

(Section 381.986(3)(b), F.S.)

$500

$1,000

(d)

Illegally acquiring marijuana from an entity other than a medical marijuana treatment center.

(Section 381.988 (4), F.S.)

$5,000

$10,000

(e)

Selling, distributing, or transferring marijuana, except to transfer a sample to another marijuana testing laboratory in Florida.

(Section 381.988(4), F.S.)

$5,000

$10,000

(f)

Failing to properly dispose of a sample received.

(Section 381.988(5), F.S.)

$1,000

$2,000

(g)

Being owned or controlled by an MMTC.

(Section 381.988(1)(a), F.S.)

(64ER21-14(4)(g))

$5,000

$10,000

(h)

Permitting unauthorized persons to perform technical procedures or issue reports.

(Section 381.988(7)(a), F.S.)

$500

$1,000

(i)

Demonstrating incompetence or making consistent errors in the performance of testing or erroneous reporting.

(Section 381.988(7)(b), F.S.)

$1,000

$5,000

(j)

Performing a test and rendering a report thereon to a person or entity not authorized by law to receive such services.

(Section 381.988(7)(c), F.S.)

$5,000

$10,000

(k)

Failing to file any report required under ss. 381.986, 381.988, F.S., or department rules.

(Section 381.988(7)(d), F.S.)

$500

$1,000

(l)

Reporting a test result if the test was not performed.

(Section 381.988(7)(e), F.S.)

$5,000

$10,000

(m)

Violating or aiding and abetting in the violation of any provision of s. 381.986, s. 381.988, F.S., or department rules.

(Section 381.988(7)(g), F.S.)

$5,000

$10,000

(n)

Testing marijuana or providing results to an MMTC while required accreditation is lost or suspended.

(64ER22-5(5)(b))

$5,000

$10,000

(o)

Failing to maintain required accreditation.

(64ER20-14(4)(a))

$5,000

$10,000

(p)

Failing to report loss or suspension of required accreditation or to provide required documentation. (64ER22-5(5) and 64ER22-5(5)(a))

$1,000

$2,000

(q)

Failing to comply with Proficiency Testing requirements.

(64ER20-14(4)(b), 64ER20-7(4), and 64ER20-3(1)(d))

$1,000

$2,000

(r)

Employing unqualified personnel.

(64ER20-14(4)(c))

$1,000

$2,000

(s)

Failing to maintain adequate controls against the diversion, theft, or other loss of marijuana, the tampering or compromise of samples, and the tampering or compromise of testing equipment and materials.

(64ER20-14(4)(d))

$5,000

$10,000

(t)

Failing to comply with the security requirements listed under 64ER20-14(4)(d).

(64ER20-14(4)(d))

$1,000

$5,000

(u)

Failing to maintain and utilize Standard Operating Procedures, to include a Quality Assurance Manual addressing every aspect of its Quality Assurance program.

(64ER20-6 and 64ER20-14(4)(e)1.)

$1,000

$2,000

(v)

Failing to have the Laboratory Director or authorized Employee review, amend as necessary, and approve the Testing Facility's Quality Assurance Manual and Quality Assurance program at least once a calendar year, or whenever a change of method, equipment, or Laboratory Director occurs.

(64ER20-14(4)(e)2.)

$500

$2,000

(w)

Failing to notify and request approval from the department in writing of all contractual relationships to change Control of the entity holding the certification, or to change its Managers, Owners, or Investors prior to the execution of the change.

(64ER20-14(4)(g)2.)

$5,000

$10,000

(x)

Failing to have a Laboratory Director review, approve, sign, and date each Standard Operating Procedure and each revision thereto.

(64ER20-6(4))

$500

$1,000

(y)

Failing to keep the latest revised Standard Operating Procedures on Testing Facility premises and accessible to all Employees during all hours of operation.

(64ER20-6(5))

$500

$1,000

(z)

Failing to use or properly maintain testing equipment when testing Final Product.

(64ER20-14(4)(e)3. and 64ER20-7(3))

$1,000

$2,000

(aa)

Failing to maintain records in accordance with department rules.

(64ER20-4(2) and 64ER20-12(4))

$1,000

$2,000

(bb)

Failing to perform internal audits.

(64ER20-14(4)(e)5.)

$1,000

$2,000

(cc)

Failing to maintain or utilize an operational tracking system.

(64ER20-14(4)(e)6.)

$5,000

$10,000

(dd)

Failing to obtain required background screenings.

(Section 381.988(1)(d), F.S.)

(64ER20-15 and 64ER20-14(4)(f))

$500

$1,000

(ee)

Failing to notify the department after becoming aware of any of the disqualifying offenses as provided in 64ER20-15(4)(a).

(64ER20-15(4)(a))

$1,000

$2,000

(ff)

Failing to terminate an Employee or Manager or remove the Owner from his or her position after receiving written notice from the department that CMTL Owner, Manager, or Employee is ineligible to serve as a CMTL Owner, Manager, or Employee.

(64ER20-15(4)(b))

$1,000

$2,000

(gg)

Performing Testing Fields within Matrix Groups for which the CMTL is not approved to perform.

(64ER20-3)

$1,000

$2,000

(hh)

Testing and providing results to an MMTC for a Target Analyte, Matrix, or other measure for which its analysis was unsatisfactory when the CMTL has failed to satisfactorily complete two of the three most recent Proficiency Testing rounds.

(64ER20-3(3))

$2,000

$5,000

(ii)

Resuming testing for any Target Analyte, Matrix, or other measurement for which its analysis was unsatisfactory prior to providing the department with satisfactory Proficiency Testing Results from the required accredited body.

(64ER20-3(3))

$2,000

$5,000

(jj)

Refusing to allow entry or inspection of a CMTL Testing Facility, including any vehicle utilized by a CMTL.

(64ER20-4(1))

$5,000

$10,000

(kk)

Failing to cooperate or provide responses to the department's inquiries during an inspection.

(64ER20-4(2))

$500

$2,000

(ll)

Failing to resolve a deficiency or violation in the time period required by the department or specified in a corrective action plan.

(Section 381.988(7)(f), F.S.)

(64ER20-4(7) and 64ER22-5(4))

$5,000

$10,000

(mm)

Using an unapproved Analytical Method.

(64ER20-7)

$500

$1,000

(nn)

Failing to demonstrate an Initial Display of Competency for a testing method prior to analyzing an Analytical Sample using the method.

(64ER20-7(2))

$500

$1,000

(oo)

Failing to follow required field sampling protocols when sampling Final Product for testing.

(64ER20-38)

$500

$1,000

(pp)

Failing to maintain and implement a chain of custody protocol.

(64ER20-38(3))

$1,000

$2,000

(qq)

Failing to obtain an adequate number of Final Products for testing.

(64ER20-38(4))

$500

$1,000

(rr)

Failing to transport samples in a manner that prevents degradation, contamination, commingling, and tampering.

(64ER20-38(6))

$1,000

$2,000

(ss)

Failing to prepare Testing Samples within established timeframes.

(64ER20-38(7))

$500

$1,000

(tt)

Failing to notify the department if the CMTL is unable to complete regulatory compliance testing after sampling.

(64ER20-38(8)

$500

$1,000

(uu)

Failing to comply with 64ER20-36, when resampling and retesting a previously failed Retail Batch.

(64ER20-38(9))

$500

$5,000

(vv)

Failing to transport samples in accordance with 64ER20-38.

(64ER20-38(10))

$500

$1,000

(ww)

Failing to generate a Certificate of Analysis for each Final Product tested that contains all required information as enumerated in 64ER20-12(1)(a)-(c).

(64ER20-12(1))

$500

$1,000

(xx)

Reporting false or inaccurate information on a Certificate of Analysis.

(64ER20-12)

$1,000

$10,000

(yy)

Failing to create and maintain Data Packages for every analyzed Laboratory Batch.

(64ER20-12(2))

$1,000

$2,000

(zz)

Failing to include the required information enumerated in 64ER20-12(2)(a)-(r) for each Data Package.

(64ER20-12(2))

$1,000

$2,000

(aaa)

Failing to have a Certificate of Analysis and Data Package reviewed by the CMTL's Laboratory Director, or designee, prior to dissemination.

(64ER20-12(3))

$500

$1,000

(bbb)

Failing to provide requested documentation to the department within the timeframe required by 64ER20-12(5).

(64ER20-12(5))

$500

$2,000

(ccc)

Failing to perform reanalysis of a failed Target Analyte in accordance with 64ER20-39(1)(b) and (c).

(64ER20-39(1)(b) and (c))

$1,000

$2,000

(ddd)

Failing to report testing failures to the department.

(64ER20-39(1)(e))

$5,000

$10,000

(eee)

Failing to provide the information required under 64ER20-39(1)(f) to the department after resampling and retesting a previously failed Retail Batch.

(64ER20-39(1)(f))

$1,000

$2,000

(fff)

Failing to report Testing Samples found to contain a contaminant that could be injurious to human health.

(64ER20-39(7))

$1,000

$5,000

(ggg)

Failing to maintain at least one sterile untested portion of each Testing Sample in accordance with 64ER20-39(8).

(64ER20-39(8))

$500

$1,000

(hhh)

Failing to use Quality Control samples.

(64ER20-10)

$1,000

$5,000

(iii)

Continuing to conduct an analysis of a Quality Control sample that continues to fall outside of accepted criteria after reanalysis and being tested as a new Laboratory Batch.

(64ER20-10(1)(h))

$1,000

$2,000

(jjj)

Failing to generate Quality Control sample reports in accordance with 64ER20-10.

(64ER20-10(1)(i))

$1,000

$5,000

(kkk)

Failing to prepare Calibration Standards in compliance with 64ER20-11.

(64ER20-11)

$1,000

$2,000

(lll)

Failing to comply with all applicable federal and state laws and regulations for solid and liquid wastes and any applicable local regulations or ordinances.

(64ER21-6(2))

$1,000

$2,000

(mmm)

Failing to render marijuana waste unusable and unrecognizable or irretrievable in accordance with 64ER21-6.

(64ER21-6(3) and (4))

$1,000

$5,000

(nnn)

Failing to dispose of unusable and unrecognizable or irretrievable marijuana waste in accordance with 64ER21-6.

(64ER21-6(5))

$1,000

$5,000

(ooo)

Failing to maintain and comply with a waste management plan in accordance with 64ER21-6.

(64ER21-6(6))

$1,000

$2,000

(ppp)

Failing to maintain records of generated marijuana waste in accordance with 64ER21-6.

(64ER21-6(7))

$500

$1,000

(qqq)

A violation of any other provision of s. 381.986, s. 381.988, F.S., or department rule, not listed in this chart.

(Section 381.988(8), F.S.)

(64ER22-5)

$100

$10,000

Fla. Admin. Code Ann. R. 64ER22-5

Rulemaking Authority 381.988(8), 381.988(9), FS; Law Implemented 381.986, 381.988, FS.

Adopted by Florida Register Volume 48, Number 130, July 6, 2022 effective 6/28/2022.