Prior to the transmission of test results to the employer,
both positive and negative test results shall be reviewed and verified by a
medical review officer (MRO) qualified under subsection
59A-24.008(1),
F.A.C. The MRO is permitted to use a language interpreter to assist in
communicating the results of drug tests with employees and job applicants. Such
language interpreters are subject to the confidentiality provisions of Section
112.0455(11),
F.S. After the results have been reviewed and verified by the MRO, the test
result is reported to the employer.
(1)
Qualifications of Medical Review Officers.
(a)
Persons serving as medical review officers shall be medical or osteopathic
physicians duly licensed in the state in which he or she practices
medicine.
(b) The MRO shall have
knowledge of substance abuse disorders, laboratory testing procedures, chain of
custody procedures, collection procedures, and have the appropriate medical
training to interpret and evaluate an individual's drug test result together
with the individual's medical history or any other biomedical
information.
(c) Medical review
officers shall be certified as medical review officers by the American
Association of Medical Review Officers, American Society of Addiction Medicine
or the Medical Review Officer Certification Council.
(d) The MRO shall be employed by or
contracted by the employer and shall not be employed or contracted by a drug
testing laboratory performing drug free workplace testing under Section
112.0455, F.S. The drug testing
laboratory is permitted to assist the employer in locating qualified medical
review officers.
(e) An employer
shall not serve as the MRO for his or her own employees and job
applicants.
(2)
Responsibilities of Medical Review Officer. The MRO shall evaluate the drug
test result(s), which is reported out by the laboratory, to verify by checking
the chain of custody form that the specimen was collected, transported, and
analyzed under proper procedures, as specified in these rules, and to determine
if any alternative medical explanations caused a positive test result. This
determination could include conducting a medical interview with the individual,
review of the individual's medical history, or the review of any other relevant
bio-medical factors. The MRO shall review all medical records made available by
the tested individual. The MRO shall not consider the results of samples that
are not obtained or processed in accordance with these rules.
(a) Negative Results. To verify that a
negative test result was properly analyzed and handled according to these
rules, the MRO shall:
1. Receive and review
the test result(s) from the laboratory;
2. Verify the laboratory report by checking
the chain of custody form for required signatures, procedures, and
information;
3. Ensure that the
donor's specimen identification number on copy 2 of the laboratory test report
and on copy 4 of the chain of custody form which was sent to the MRO by the
collection site accurately identifies the donor with the negative test result;
and,
4. Notify the employer in
writing of the negative test result no more than 7 working days after the
specimen was received by the laboratory, and appropriately file Copy 2 and 4 of
the chain of custody form under confidential procedures for a period of 2
years.
5. Within 24 hours of
notification of the employer of a negative test result, notify the testing
laboratory that the negative test result has been submitted to the
employer.
(b) Positive
Results. To verify that a positive test result was properly analyzed and
handled according to these rules, the MRO shall:
1. Receive and review the test result(s) from
the laboratory;
2. Verify the
laboratory report by checking the chain of custody form for required
signatures, procedures, and information;
3. Ensure that the donors specimen
identification number on Copy 2 of the laboratory test report and on Copy 4 of
the chain of custody form which was sent to the MRO by the collection site
accurately identifies the donor with the positive test result;
4. Notify the employee or job applicant of a
confirmed positive test result, within 3 days of receipt of the test result
from the laboratory, and inquire as to whether prescriptive or over-the-counter
medications could have caused the positive test result;
5. Within 5 days of notification to the donor
of the positive test result, provide an opportunity for employee or job
applicant to discuss the positive test result and to submit documentation of
any prescriptions relevant to the positive test result;
6. Review any medical records provided by the
employee or job applicant, or authorized by the employee or job applicant and
released by the individual's physician, to determine if the positive test
result was caused by a legally prescribed medication. If the donor does not
have prescribed medication, the MRO shall inquire about over-the-counter
medications which could have caused the positive test result. The donor shall
be responsible for providing all necessary documentation, (i.e., a doctor's
report, signed prescription, etc.) within the 5 day period after notification
of the positive test result;
7.
Notify the employer in writing of the verified test result, either negative,
positive, or unsatisfactory, no more than 7 working days after the specimen was
received by the laboratory, and appropriately file the chain of custody form
under confidential procedures for 2 years;
8. If the MRO determines that there is a
legitimate medical explanation for the positive test result, based on the
medical judgment of the MRO and accepted standards of practice, the MRO shall
report a negative test result to the employer;
9. Process any employee or job applicant
requests for a retest of the original specimen, within 180 days of notice of
the positive test result, at another licensed laboratory selected by the
employee or job applicant. The donor requesting the additional test shall be
required to pay for the costs of the retest, including handling and shipping
expenses. The MRO shall contact the original testing laboratory to initiate the
retest; and,
10. The MRO shall not
declare a confirmed positive as verified, until the MRO receives Copy 2 of the
chain of custody form from the drug testing laboratory and Copy 4 from the
collection site.
(3) Chain of Custody Procedures. A strict
chain of custody procedure, initiated at the time of specimen collection, is
mandatory for the validation of any test result. The MRO shall be responsible,
before reporting either positive or negative test result(s) to the employer, to
review all signatures, procedures, and information as required on the chain of
custody form to determine that the specimen was under authorized control both
before and during laboratory analysis. If proper chain of custody procedures
have not been followed, the MRO shall declare the test result as
unsatisfactory, due to an unacceptable chain of custody procedure.
(4) Verification for Opiates. Before a
positive test for opiates is verified, the MRO shall determine that there is
clinical evidence in addition to the urine test, of illegal use of any opium,
opiate, or opium derivative (e.g., morphine/codeine). This requirement does not
apply if the GC/MS confirmation test for opiates confirms the presence of
6-monoacetylmorphine.
(5) Reanalysis
Authorized. Should any question arise as to the accuracy or validity of a test
result which has been collected and analyzed in accordance with these rules,
the MRO may order a reanalysis of the original sample at any licensed
laboratory licensed under these rules.
(6) Scientifically Unsatisfactory Results.
The MRO, based on a review of the chain of custody form, quality control data,
multiple samples and other pertinent results, is permitted to determine that
the result is scientifically unsatisfactory for further action and may request
the donor to provide another sample or request a reanalysis of the original
sample before making such decision. The MRO is permitted to request that the
reanalysis be performed by the same laboratory or, that an aliquot of the
original specimen be sent to another licensed laboratory. The laboratory shall
assist in this review process as requested by the MRO and shall make available
appropriate personnel to provide consultation as required by the MRO. The MRO
shall report all findings based on the unsatisfactory specimen, as required by
this rule chapter, but shall not include any personal identifying information
in such reports.
(7) Contacting
Donors Who Test Positive.
(a) If the MRO is
unable to contact a donor who tested positive within 3 working days of receipt
of the test results from the laboratory, the MRO shall contact the employer and
request that the employer direct the donor to contact the MRO as soon as
possible. If the MRO has not been contacted by the donor within 2 working days
from the request to the employer, the MRO shall verify the report as
positive.
(b) As a safeguard to
employees and job applicants, once a MRO verifies a positive test result, the
MRO may change the verification of the result if the donor presents information
to the MRO which documents that a serious illness, injury, or other
circumstance unavoidably prevented the employee from contacting the MRO within
the specified time frame and if the donor presents information concerning a
legitimate explanation for the positive test result.
(c) If the donor declines to talk with the
MRO regarding a positive test result, the MRO shall validate the result as
positive and annotate such decline in the remarks section.
(8) Identification of Donor. Prior to
providing an employee or job applicant with the opportunity to discuss a test
result, the MRO shall confirm the identity of the employee or job applicant. At
a minimum, to confirm the identity of the donor, the MRO shall ask the donor to
respond with the following information:
(a) If
the request is in person, the MRO shall request a picture
identification.
(b) If the request
is over the telephone, the MRO shall request:
1. An employee identification number or
social security number;
2. Date of
birth;
3. Employer's name; and,
4. Work telephone
number.
(9)
Information for Donor. Once the donor's identification has been established,
and before any additional information is solicited from the donor, the MRO
shall:
(a) Inform the donor that the MRO is an
agent of the employer whose responsibility is to make a determination on test
results and report them to the employer;
(b) Inform the donor that medical information
revealed during the MRO's inquiry will be kept confidential; unless the donor
is in a safety sensitive or special risk position and the MRO believes that
such information is relevant to the safety of the donor or to other employees.
Any additional release of information shall be solely pursuant to a written
consent form signed voluntarily by the donor, except where such release is
compelled by a hearing officer or a court of competent jurisdiction pursuant to
an appeal, or where deemed appropriate by a professional or occupational
licensing board in a related disciplinary proceeding.
(c) Outline the rights and procedures for a
retest of the original specimen by the donor.
(d) If the donor voluntarily admits to the
use of the drug in question without a proper prescription, the MRO shall advise
the donor that a verified positive test report will be sent to the
employer.
(10)
Verification Signature. After the MRO reviews the chain of custody forms from
the laboratory and the collection site (Copy 2 from the laboratory and Copy 4
from the collection site) and, in the case of a positive test result, has
contacted the donor who tested positive, the MRO shall:
(a) On Copy 2 of the chain of custody form,
mark the appropriate box if the verified result is positive or negative and if
positive, write in for which drug(s). If the test was not performed or the test
was canceled, mark the appropriate box. The reason for the cancellation or
non-performance of the test shall be explained in the remarks
section.
(b) On Copy 2 of the chain
of custody form, sign and date the verification of the final test
result.
(c) Prepare and sign a
verification letter to the employer revealing the final verified test result.
Copies of the laboratory report form or chain of custody are not suitable for
this purpose.