Laboratories shall be licensed by the agency in accordance
with Sections 112.0455, 440.102, and Chapter 408, Part II, F.S., and this rule
chapter in order to collect or analyze specimens for an employer's drug testing
program.
(1) Laboratory Personnel.
(a) Qualifications of Director. The
laboratory shall have a qualified director to assume professional, technical,
educational, and administrative responsibilities for the laboratory's drug
testing. The director shall meet one of the following requirements:
1. Is duly licensed as a physician in the
state in which he or she practices medicine; and is licensed under Chapters 458
or 459, F.S., if the laboratory is located in the State of Florida; and has had
at least four years of experience in forensic analytical toxicology;
or
2. Holds a doctoral degree from
an accredited institution with Chemistry, Toxicology or Pharmacology as a major
subject of study; and has had at least four years of experience in forensic
analytical toxicology; and shall be licensed as a director under Chapter 483,
Part IV, F.S., in the specialty of clinical chemistry, if the laboratory is
located in the State of Florida.
(b) Responsibilities of Director. The
director shall be responsible for the following:
1. The director shall be engaged in and
responsible for the day-to-day management of the drug testing
laboratory.
2. The director shall
be engaged in and responsible for ensuring that there are sufficient personnel
with adequate training and experience to supervise and conduct the work of the
drug testing laboratory. He or she shall assure the continued competency of
laboratory personnel by documenting their inservice training, reviewing their
work performance, and verifying their skills.
3. The director shall ensure that the
laboratory has a procedure manual which is complete, up-to-date, available to
the personnel performing tests. All such procedures must, at a minimum, meet
the requirements stipulated in this rule chapter. The director shall ensure
that the procedures are followed by personnel performing tests. The procedure
manual shall be reviewed, signed, and dated by this director whenever
procedures are first placed into use, or changed, or when a new director
assumes responsibility of the drug testing laboratory.
4. The director shall be responsible for
maintaining a quality assurance program to assure the proper performance and
reporting of all test results; for maintaining acceptable analytical
performance for all controls and standards; for maintaining quality control
testing; and for assuring and documenting the validity, reliability, accuracy,
precision, and performance characteristics of each test and test
system.
5. The director shall be
responsible for taking all remedial actions necessary to maintain satisfactory
operation and performance of the laboratory. The director shall ensure that
sample results are not reported until all corrective actions have been taken
and that he or she can assure that the tests results provided are accurate and
reliable.
(c) Certifying
Scientists. The laboratory shall have a qualified individual who serves as
certifying scientist. This individual reviews all pertinent data and quality
control results in order to attest to the validity of the laboratory's test
reports. A laboratory may designate more than one person to perform this
function.
1. The certifying scientist(s) shall
have a minimum of 2 years experience in forensic analytical toxicology and be
qualified as a director or licensed as a supervisor under the provisions of
Chapter 483, Part IV, F.S., in the specialty of clinical chemistry if the
laboratory is located in the State of Florida.
2. The laboratory director is permitted to
designate technical personnel to certify results that are negative on the
initial screening test. These individuals shall be technologists licensed in
the specialty of clinical chemistry in accordance with the provisions of
Chapter 483, Part IV, F.S., if the laboratory is located in the State of
Florida.
(d) Laboratory
Operation and Supervision.
1. The laboratory's
drug testing facility shall have an individual(s) responsible for day-to-day
operation of the laboratory and the supervision of the technical analysts. This
individual(s) shall be licensed as a laboratory supervisor in the specialty of
clinical chemistry or qualified as a director in accordance with Chapter 483,
Part IV, F.S., in the specialty of clinical chemistry if the laboratory is
located in the State of Florida; and,
2. Have a minimum of 2 years experience in
forensic analytical toxicology.
(e) Technical and Non-Technical Personnel.
1. Technical personnel shall have the
training and skills to conduct forensic toxicology testing and shall be
licensed in accordance with Chapter 483, Part IV, F.S., if the laboratory is
located in the State of Florida. Documentation of such training and skills
shall be maintained by the laboratory and available upon request by the
agency.
2. Non-technical personnel,
including all persons collecting specimens under these rules shall have the
necessary training and skills for the tasks assigned but shall not perform drug
testing.
(f) Collection
Site Person or Persons Collecting Specimens. A specimen for a drug test shall
be taken or collected by:
1. A physician, a
physician's assistant, a registered professional nurse, a licensed practical
nurse, a nurse practitioner, or a certified paramedic who is present at the
scene of an accident for the purpose of rendering emergency medical service or
treatment.
2. A qualified person
employed by a licensed laboratory who has the necessary training and skills for
the assigned tasks.
(2) Training. The laboratory's drug testing
program shall make available continuing education programs to meet the needs of
laboratory personnel.
(3) Files.
Laboratory personnel files shall include: resume of training and experience;
certification or license, if any; references; job descriptions; records of
performance evaluations and advancement; incident reports; and results of tests
which establish employee competency for the position he or she holds, such as a
test for color blindness, if appropriate.
(4) Specimen Security and Analysis
Procedures.
(a) Specimen Security and Internal
Chain of Custody.
1. Drug testing laboratories
shall be secure at all times. They shall have in place sufficient security
measures to control access to the premises and to ensure that no unauthorized
personnel handle specimens or gain access to the laboratory processes or to
areas where records or specimens are stored. Access to these secured areas
shall be limited to specifically authorized individuals whose authorization is
documented. For the purposes of subparagraph
59A-24.006(4)(a)
1., F.A.C., authorized individuals means those persons designated by the
laboratory to have access to the drug testing laboratory. All authorized
visitors, including maintenance and service personnel, shall be escorted by
laboratory personnel at all times. Documentation of individuals accessing these
areas, dates, time of entry and egress, and purpose of entry must be maintained
for no less than 2 years.
2.
Laboratories shall use internal chain of custody procedures to maintain control
and accountability of specimens from receipt through completion of testing,
reporting of results, during storage, and continuing until final disposition of
specimens. The date and purpose shall be documented on the internal chain of
custody form each time a specimen is handled or transferred, and every
individual in the chain shall be identified. Accordingly, authorized personnel
shall be responsible for each specimen or aliquot in their possession and shall
sign and complete internal chain of custody forms for those specimens or
aliquots as they are received. Aliquots and internal chain of custody forms
shall be used by laboratory personnel for conducting both initial and
confirmation tests.
(b)
Receiving Specimens. When a shipment of specimens is received, laboratory
personnel shall inspect each package for evidence of possible damage or
tampering and compare information listed on specimen containers within each
package to the information on the accompanying chain of custody forms. The
laboratory shall establish written standards for the rejection or acceptance of
specimens. In addition, any evidence of tampering, mismatched or omitted
specimen identification numbers, spillage, damage or other discrepancies in the
information on specimen containers and the chain of custody form shall render a
specimen invalid and shall be rejected by the laboratory for testing. The
laboratory shall immediately report any rejection to the employer and shall
note such rejection on the chain of custody form.
(c) Short-Term Refrigerated Storage. Urine or
blood specimens that do not receive an initial test within 72 hours of arrival
at the laboratory shall be placed in locked, secure refrigerated units.
Temperatures of these units shall not exceed 6 degrees Celsius. Emergency power
equipment shall be available and used in case of power failure.
(d) Specimen Testing Requirements. A
laboratory must be capable of testing for all drugs listed in Section
112.0455(5)(a),
F.S., and be capable of conducting testing to ensure that a specimen has not
been diluted or adulterated. The laboratory shall test and report drug test
results no more than 3 working days after the receipt of the specimen in the
laboratory.
(e) Initial Test. The
initial screen for all drugs shall be an immunoassay except that the initial
test for alcohol shall be an enzyme oxidation methodology.
1. Levels on initially screened urine
specimens which are equal to or exceed the following shall be considered to be
presumptively positive and submitted for confirmation testing:
|
Amphetamines
|
1, 000 ng/mL
|
|
Cannabinoids (11-nor-Delta-9-
tetrahydrocannabinol-9-carboxylic acid)
|
50 ng/mL
|
|
Cocaine (benzoylecgonine)
|
300 ng/mL
|
|
Phencyclidine
|
25 ng/mL
|
|
Methaqualone
|
300 ng/mL
|
|
Opiates
|
2, 000 ng/mL
|
|
Barbiturates
|
300 ng/mL
|
|
Benzodiazepines
|
300 ng/mL
|
|
Methadone
|
300 ng/mL
|
|
Propoxyphene
|
300 ng/mL
|
The only specimen for alcohol testing shall be blood and the
initially screened specimen shall be considered presumptively positive and
submitted for confirmation testing if the level is equal to or exceeds 0.04
g/dL.
2. Levels which exceed
the following for hair specimens shall be considered presumptively positive on
initial screening and submitted for confirmation testing:
|
Marijuana
|
10 pg/10 mg of hair
|
|
Cocaine
|
5 ng/10 mg of hair
|
|
Opiate/synthetic narcotics and metabolites
|
5 ng/10 mg of hair
|
|
Phencyclidine
|
3 ng/10 mg of hair
|
|
Amphetamines
|
5 ng/10 mg of hair
|
3.
Laboratories are permitted to use multiple screening tests for the same drug or
drug class to eliminate any possible presumptive positives due to structural
analogs, provided that such tests meet the requirements of this rule
chapter.
(f) Confirmation
Test. All specimens identified as presumptively positive on the initial test
shall be confirmed using mass spectrometry/mass spectrometry (MS/MS) or gas
chromatography/mass spectrometry (GC/MS), except that alcohol will be confirmed
using gas chromatography. All confirmations shall be done by quantitative
analysis.
1. Levels on confirmation testing
for urine specimens which are equal to or exceed the following shall be
reported as positive:
|
Amphetamines (amphetamine,
methamphetamine)1
|
500 ng/mL
|
|
Cannabinoids (11-nor-Delta-9-tetrahydrocannabinol-
9-carboxylic acid)
|
15 ng/mL
|
|
Cocaine (benzoylecgonine)
|
150 ng/mL
|
|
Phencyclidine
|
25 ng/mL
|
|
Methaqualone Opiates
|
150 ng/mL
|
|
Codeine
|
2000 ng/mL
|
|
Morphine
|
2000 ng/mL
|
|
6-Acetylmorphine2
|
10 ng/mL
|
|
Barbiturates
|
150 ng/mL
|
|
Benzodiazepines
|
150 ng/mL
|
|
Methadone
|
150 ng/mL
|
|
Propoxyphene
|
150 ng/mL
|
1A laboratory shall not report a
specimen positive for methamphetamine only. The specimen must contain
amphetamine at a concentration equal to or greater than 200 ng/mL, by the
confirmation test. If this criterion is not met, the specimen shall be reported
as negative for methamphetamine.
2Tests for 6-Acetylmorphine when
the morphine concentration exceeds 2000 ng/mL.
The alcohol level on confirmation testing for blood which is
equal to or exceeds 0.04 g/dL shall be reported as positive.
2. Levels for hair specimens on confirmation
testing which are equal to or exceed the following shall be reported as
positive:
|
Marijuana Metabolites
|
1 pg/10 mg of hair
|
|
Cocaine
|
5 ng/10 mg of hair
|
|
Opiate/synthetic narcotics and metabolites
|
5 ng/10 mg of hair
|
|
Phencyclidine
|
3 ng/10 mg of hair
|
|
Amphetamines
|
5 ng/10 mg of hair
|
(g) Reporting Results.
1. The laboratory shall report all test
results to the MRO indicated on the chain of custody form. Before any test
result is reported by the laboratory, the results of initial tests,
confirmation tests, and quality control data of such tests shall be reviewed by
the certifying scientist and the test certified as an accurate report. The
report, at a minimum, shall identify the drugs or metabolites tested for, the
results of the drug test either positive or negative, the specimen number
assigned on the chain of custody form, the name and address of the laboratory
performing the testing, and the drug testing laboratory's specimen accession
number.
2. The following criteria
shall be used when reporting drug testing results.
a. Specimens that test negative as specified
in subparagraphs
59A-24.006(4)(e)
1. and 2., F.A.C., on the initial test shall be reported as negative. If an
employer wishes to retest a negative specimen under the provisions of Section
112.0455(9)(a),
F.S., such testing is authorized to be conducted only once and must be
requested no more than 7 working days from the time the original negative test
result was reported to the employer by the MRO. Hair specimens may be
re-collected only once to perform repeat confirmation testing under the
provisions of Section
112.0455(9)(a),
F.S.
b. Specimens that test
positive as specified in subparagraph
59A-24.006(4)(e)
1., F.A.C., on initial immunoassay tests, but test negative as specified in
paragraph
59A-24.006(4)(f),
F.A.C., on confirmation shall be reported as negative.
c. The laboratory is permitted to report drug
test results for specimens that do not meet the adulteration/dilution criteria
of the laboratory. Reports on specimens that do not meet the laboratory's
adulteration/dilution requirements shall not indicate the actual results of the
adulteration/dilution tests, but the report shall indicate the
adulteration/dilution test results in non-quantitative terms.
d. The laboratory report shall indicate
solely that the test(s) resulted in a positive drug test result or resulted in
a negative drug test result.
3. The MRO may request from the laboratory,
and the laboratory shall provide, detailed quantification of initial and
confirmation test results.
4. The
laboratory may transmit results to the MRO by various electronic means (for
example, teleprinter, facsimile, or computer) in a manner designed to ensure
confidentiality of the information. The laboratory and MRO must ensure the
security of the data transmission and restrict access to any data transmission,
storage, and retrieval system to only those individuals authorized under these
rules to obtain such information.
5. The laboratory shall send the MRO a copy
of the original chain of custody form (Copy 2) signed by the certifying
scientist responsible for attesting to the validity of the test
report.
6. The laboratory shall
make available copies of all analytical results of donor testing upon request
by the MRO or the agency.
7. Unless
otherwise specified in this rule chapter, all records pertaining to a given
specimen shall be retained by the drug testing laboratory for a minimum of 2
years.
(h) Storage of
Specimens. Drug testing laboratories shall retain and place all confirmed
positive urine specimens in locked, secured long-term frozen storage (-15°
degrees Celsius or less) and confirmed positive blood specimens in locked,
secured long-term refrigerated storage (2-8° degrees Celsius) for a minimum
of 210 days. Within this 210 day period an employer, employee, job applicant,
or MRO is permitted to request in writing that the laboratory retain the
specimen for an additional period of time. If no such request is received, the
laboratory is permitted to discard the specimen after 210 days of storage. When
notified in writing, the laboratory shall be required to maintain any specimens
under legal challenge until such challenge is resolved. To maintain applicable
storage temperatures for stored specimens, emergency power equipment shall be
available and used in the case of power failure. After the required retention
time has passed, laboratories are permitted to either discard the specimens or
pool all or part of these specimens for use in the laboratory's internal
quality control program.
1. When an employee
or job applicant undertakes an administrative or legal challenge to the test
result, it shall be the employee's or job applicant's responsibility to notify
the employer and laboratory in writing of such challenge and such notice shall
include reference to the chain of custody specimen identification number. After
such notification, the sample shall be retained by the laboratory until the
case or administrative appeal is settled.
2. During a 180 day period after written
notification of a positive test result, the employee or job applicant who has
provided the specimen shall be permitted by the employer to have a portion of
the specimen retested, at the employee or job applicant's expense. The
laboratory which performed the original test for the employer shall be
responsible for transferring a portion of the specimen to be retested at a
second laboratory licensed under these rules, selected by the employee or job
applicant, and shall be responsible for the integrity of the specimen and for
the chain of custody during such transfer.
3. Urine specimens that test negative shall
be stored in locked, secured refrigerated (2-8° degrees Celsius) or frozen
storage (-15° degrees Celsius or less). Blood specimens that test negative
shall be stored in locked, secured, refrigerated storage (2-8° degrees
Celsius). These specimens shall be retained for no less than 7 working days
after the test result has been reported to the employer by the MRO. After the
required retention time has passed, laboratories are permitted to either
discard the specimens or pool all or part of these specimens for use in the
laboratory's internal quality control program.
4. The laboratory is permitted to discard or
pool specimens that test negative immediately after the negative test result is
transmitted to the MRO, provided that the laboratory has written authorization
from the employer that specimens which test negative are not to be retained for
retesting under Section
112.0455(9)(a),
F.S.
5. Under no circumstances
shall a laboratory be required to retain a specimen, which has been reported as
negative, for a period longer than 14 working days after receipt of that
specimen in the laboratory unless a confirmation test has been requested by the
employer under the provisions of Section
112.0455(9)(a),
F.S.
(i) Retesting
Specimens. As some analytes deteriorate or are lost during freezing,
refrigeration, or storage, quantification for a retest is not subject to a
specific cutoff requirement but must provide data sufficient to detect the
presence of the drug or metabolite.
(5) Subcontracting. Drug testing laboratories
shall not subcontract, except for collection sites, and shall perform all
analysis with their own personnel and equipment. The laboratory must be capable
of performing testing for the classes of drugs defined in Section
112.0455(5)(a),
F.S., using the specimens indicated in Section
112.0455(5)(k),
F.S., and initial and confirmation methods specified in paragraphs
59A-24.006(4)(e) and
(f), F.A.C.
(6) Contracted Collection Sites. Collection
sites or collectors shall contract with laboratories licensed under this rule
chapter to collect specimens for analysis. Such contracts shall be in writing
and include the utilization of all the necessary facilities, personnel,
materials, equipment, or other supplies, as needed, to collect specimens as
required in Rule
59A-24.005, F.A.C. For the
purposes of Section
112.0455(8)(e),
F.S., persons collecting specimens under contract with a forensic drug testing
laboratory shall be deemed to be employees of the licensed laboratory. In
addition, the collectors shall be trained by, and shall be accountable to, the
licensed laboratory. However, after an accident, if an employee is taken to a
facility for medical treatment and the facility does not have a contract with
the laboratory, an individual authorized in paragraph
59A-24.006(1)(f),
F.A.C., is permitted to collect a specimen provided that this collector
utilize, and complete to the fullest extent possible, a chain of custody form.
In addition, the collector shall follow the collection procedures found in Rule
59A-24.005, F.A.C., to the
fullest extent possible and shall maintain full control of the specimen until
the specimen is sealed and packaged for shipment to the employer's selected
laboratory.
(7) Inspections. The
agency shall conduct announced or unannounced inspections of the laboratory at
any reasonable time for the purpose of determining compliance with this rule
chapter. The right of entry and inspection shall also be extended to any
collection sites under contract with the laboratory. Inspections shall document
the overall quality of the laboratory setting for the purpose of licensure to
conduct drug free workplace testing. Inspection reports shall also contain any
requirements of the laboratory to correct deficiencies noted during the
inspections.
(a) Prior to laboratory licensure
and biennially thereafter, an on-site inspection of the laboratory shall be
conducted.
(b) Laboratories
certified by the federal Department of Health and Human Services Federal
Workplace Drug Testing Programs shall submit an inspection report of the
federal Department of Health and Human Services Federal Workplace Drug Testing
Programs performed within the previous 24 months in lieu of the required
on-site inspection. In addition, such laboratories certified by the federal
Department of Health and Human Services Federal Workplace Drug Testing Programs
shall:
1. Maintain a policy to conduct the
testing of all specimens authorized under Section
112.0455, F.S., in the same
manner as required for those drugs included under the Mandatory Guidelines for
Federal Workplace Drug Testing Programs. This policy must be in writing and
contained in the laboratory's policy and procedure manual.
2. Submit to the agency all reports of such
inspections, post inspection activities and reports including any corrective
action taken by the laboratory within 45 days of the receipt of the initial
evaluation report in the laboratory.
3. Request in writing that the inspection
report be accepted in lieu of an on-site inspection by the
agency.
(c) Laboratories
that are accredited by a nationally recognized accreditation organization may
submit an accreditation survey report performed within the previous 24 months
and proof of non-provisional accreditation or reaccreditation in lieu of the
on-site inspection.
(8)
Documentation. Laboratories shall maintain and make available for at least 2
years all documentation of the testing process. Except that the laboratory
shall be required to maintain documents and records for any specimen(s) under
legal challenge until such challenge is resolved. The required documentation
shall include:
(a) Personnel files on all
individuals authorized to have access to specimens;
(b) Chain of custody documents;
(c) Quality assurance records;
(d) Quality control records;
(e) Procedure manuals;
(f) All test data, calibration curves and any
calculations used in determining test results;
(g) Donor test reports;
(h) Proficiency testing records;
and,
(i) Computer generated data
used for testing and reporting specimen results.
(9) Additional Requirements for Laboratory
Licensure.
(a) Standards and Controls.
Laboratory standards shall be prepared with pure drug standards which are
properly labeled as to content and concentration. The standards shall be
labeled with dates indicating when received, when prepared or opened, when
placed in service, and the expiration date.
(b) Instruments and Equipment.
1. Volumetric pipettes and measuring devices
shall be certified for accuracy or be checked by gravimetric, colorimetric, or
other verification procedures on a quarterly basis. Automatic pipettes and
dilutors shall be checked for accuracy and reproducibility before being placed
in service and checked quarterly thereafter.
2. There shall be written procedures for
instrument setup and normal operation, a schedule for checking critical
operating characteristics for all instruments, tolerance limits for acceptable
function checks and instructions for major trouble shooting, repair, and
maintenance in accordance with manufacturer's specifications. Manufacturer's
specifications for, and records of preventive and regular maintenance shall be
maintained for as long as the instrument is in use and for at least 2 years
after the instrument is discontinued from use and shall be available upon
request by the agency.
(c) Remedial Actions. There shall be written
procedures for the actions to be taken when test systems are not operating
correctly or errors are detected. There shall be documentation that these
procedures are followed and that all necessary corrective actions are taken.
There shall also be in place systems to verify all stages of testing and
reporting and documentation that these procedures are followed.
(d) Personnel Available to Testify at
Proceedings. A laboratory director shall assure that technical personnel,
including the director, be available to testify in an administrative or
disciplinary proceeding regarding any employee or a job applicant when that
proceeding is based on a test result which was analyzed and reported by the
laboratory.
(10) Quality
Assurance and Quality Control. Quality assurance and quality control for hair
analyses shall be conducted in accordance with Section 112.0455(13)(b)4., F.S.
(a) General. Drug testing laboratories shall
have a quality assurance program which encompasses all aspects of the testing
process including but not limited to specimen acquisition, chain of custody,
security and reporting of results, initial and confirmation testing and
validation of analytical procedures. Quality assurance procedures shall be
designed, implemented, and reviewed to monitor the conduct of each step of the
process of testing for drugs.
(b)
Laboratory Quality Control Requirements for Initial and Confirmation Tests. At
a minimum, each analytical run of specimens for an initial or confirmation test
shall include the following quality control samples:
1. Negative specimens certified to contain no
drug;
2. Urine specimens fortified
with known standards; and,
3.
Positive controls with the drug or metabolite at or near the threshold
(cutoff).
4. At least 1 percent of
each initial screening run, with a minimum of one sample per run, shall consist
of a blind sample(s) of known concentration. Such samples shall appear as
ordinary test specimens to the laboratory
analysts.
(11)
Proficiency Testing. Proficiency testing is required as a continuing assessment
of laboratory performance necessary to maintain continued licensure.
(a) General Considerations.
1. The laboratory must successfully
participate in proficiency testing surveys, as described in subsection
59A-24.006(11),
F.A.C.
2. Proficiency testing
specimens are permitted to consist of negative specimens as specified in
subparagraph
59A-24.006(4)(e)
1., F.A.C., and positive specimens, as specified in paragraph
59A-24.006(4)(f),
F.A.C.
3. Proficiency testing
specimens are permitted to contain interfering substances.
4. Proficiency testing specimens are
permitted to be identified for screening or confirmation testing
only.
5. All procedures associated
with the laboratory's handling and testing of any proficiency testing specimens
shall be carried out in the same manner as the laboratory tests donor
samples.
6. The laboratory shall
report results of proficiency testing samples using the same criteria applied
to routine drug testing specimens.
7. In addition to the proficiency testing
requirements, any licensed laboratory shall be subject to blind performance
testing by the agency. Blind performance testing means proficiency test samples
which are shipped to a laboratory in a manner such that the samples appear to
be actual drug testing samples.
(b) Continued Licensure. In order to remain
licensed, the laboratory shall participate in three proficiency testing surveys
supplied by an approved proficiency testing organization as defined in
subsection
59A-24.003(3),
F.A.C. per year. Failure to meet the applicable grading criteria established by
an approved proficiency testing organization shall be considered unsuccessful
proficiency testing participation. The laboratory shall submit the reports of
proficiency testing results and any corrective action taken with regards to
unsuccessful results within 14 days of their receipt in the
laboratory.
(12)
Administrative Enforcement and Hearings.
(a)
The agency shall enforce the provisions of Sections 112.0455(12) and (13) and
Chapter 408, Part II, F.S. and Chapter 59A-24, F.A.C., by administering
remedies for statutory and rule violations as provided in Sections
408.813,
408.814,
408.815 and
408.816, F.S.
(b) Grounds for Disciplinary Action. The
following actions shall result in the agency taking administrative action:
1. Failure to accurately analyze and report
donor drug tests;
2. Failure to
participate in or unsuccessful participation in proficiency testing
surveys;
3. Permitting unauthorized
persons to perform technical procedures or issue reports;
4. Demonstrating incompetence or making
consistent errors in the performance and reporting of drug free workplace
testing or proficiency testing samples;
5. Performing a test and rendering a report
thereon to a person not authorized by law to receive such services;
6. Knowingly having professional connection
with or knowingly lending the use of the name of the licensed forensic
toxicology laboratory or the license of the director to an unlicensed forensic
toxicology laboratory;
7. Violating
or aiding and abetting in the violation of any provision of this part or the
rules promulgated hereunder;
8.
Failing to file any report required by the provisions of this part or the rules
promulgated hereunder;
9. Reporting
a drug test result when no such test was performed;
10. Knowingly advertising false services or
credentials;
11. Failure to correct
deficiencies within the time required by the agency;
12. Failing to maintain a secured area for
toxicology tests; or
13. Any other
cause which affects the ability of the laboratory to ensure the full
reliability and accuracy of drug tests and the accurate reporting of
results.
14. Failure to submit
statistical reports as required in subsection
59A-24.006(14),
F.A.C.
(13)
Licensure
(a) Laboratories seeking licensure
must complete licensure application form, Health Care Licensing Application,
Drug-Free Workplace Laboratory, AHCA Form 3170-5001 July 2014, which is hereby
incorporated by reference. This form is available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-05425
or http://ahca.myflorida.com/HQAlicensureforms and from the Agency for Health
Care Administration, 2727 Mahan Drive, MS #32, Tallahassee, Florida
32308.
(b) Initial and biennial
licensure renewal fees shall be $16, 435 and shall be made payable to the
Agency for Health Care Administration.
(14) Statistical Information Reporting.
(a) The laboratory shall submit statistical
information on drug testing to the agency. No statistical information reported
to the agency shall reveal the names of the persons tested, nor shall it reveal
the employer's identity. This data shall contain the following information on
specimens received for all drug testing conducted under Sections
112.0455 or
440.102, F.S.:
1. The total number of specimens received for
testing.
2. The total number of
specimens that tested positive on the initial screening.
3. The total number of specimens that were
confirmed and reported as positive for each drug class tested.
4. The total number of samples that were
received but not tested.
(b) Statistical summaries shall be submitted
to the agency on a monthly basis no later than 14 working days after the end of
a reporting month. Reporting is required even if no Florida Drug Free Workplace
testing has been done for that reporting month.
(c) Failure of a laboratory to submit the
statistical reports as required in Sections
112.0455(12)(d)
or
440.102(9)(d),
F.S., shall result in administrative action pursuant to paragraph
59A-24.006(12)(a),
F.A.C.