Current through 2024-38, September 18, 2024
A. Laboratories
conducting substance use testing of employees and applicants must comply with
all of the following requirements, except as noted.
1. Licensure.
a. Laboratories conducting substance use
testing under this rule must be licensed by the Department for such testing.
Application for licensure must be made by the laboratory owner on forms
prescribed by the Department and must be accompanied by a non-refundable fee,
in accordance with the Schedule of Charges for Testing and Services Provided by
the Maine Health and Environmental Testing Laboratory Rule (10-144 CMR Chapter
257), as provided by
22 MRS
§565.
b. The term of the license will be one year
from the date of issue. Application for renewal must be received by the
Department at least one month before the expiration date of the current
license. Application for renewal must be accompanied by a non-refundable fee,
in accordance with 10-144 CMR Chapter 257, as provided by
22 MRS
§565.
2. Inspection
a. Laboratories must document compliance with
all of the provisions of this rule and are subject to inspection by
representatives of the Department. Initial inspection of a laboratory applying
for licensure may be conducted by the Department within 60 days of the
Departments receipt of the application and confirmation of necessary
documentation. If the laboratory is found to be in compliance with this rule,
licensure will be effective the date of the inspection. If the laboratory is
not in compliance, licensure will be effective on submission and completion of
a satisfactory plan of correction, or such other action needed to bring the
facility into compliance. Repeat inspection may be required by the
Department.
b. Subsequent
inspections may be conducted at least two times per year, and at three-month
intervals for the first six months of licensure. If the laboratory is found to
be in noncompliance, it must submit an acceptable plan of correction within 10
days. In the event of continuing non-compliance, the Department may seek
revocation of the laboratory's license pursuant to 5 MRS chapter 375,
subchapter 5. In the case of laboratories located outside the State of Maine,
the laboratory will be liable for all travel, per diem, lodging and other costs
of the inspection. Laboratories are subject to inspection at all times during
operating hours.
c. Laboratories
must notify the Department of any changes in personnel, procedures or other
factors material to the quality of testing, within 10 days of
occurrence.
d. Laboratories may be
licensed upon application, without inspection, if the laboratory is approved by
the Substance and Mental Health Services Administration's National Laboratory
Certification Program or licensed by the New York State Department of Health
Program for licensing of substance use testing laboratories.
B. Laboratories must be
in full compliance with the provisions of the Maine Medical Laboratory Act, 22
MRS, Chapter 411.
C. No employer
may perform any substance use test administered to any of that employer's
employees. As provided by law, employers may perform screening tests on their
own applicants, provided the employer's testing facility complies with the
requirements in Section
4 of this rule, in accordance with
required statutory employment practices within
26 MRS
§683(6).
D. The laboratory must have a director who
assumes professional, organizational, educational and administrative
responsibility for the laboratory's drug testing facility.
1. The director must have documented
scientific qualifications in analytical forensic toxicology. At a minimum,
these qualifications are:
a. An earned
doctoral degree in the physical, chemical or biological i sciences from an
accredited institution, with an adequate undergraduate and graduate education
in biology, chemistry, and pharmacology or toxicology, or an equivalent
educational background; and
b.
Certification in at least one laboratory specialty by the American Board of
Pathology, the American Osteopathic Board of Pathology, the American Board of
Clinical Chemistry, the American Board of Bioanalysis, or the American Board of
Forensic Toxicology; and
c.
Appropriate experience in analytical forensic toxicology including experience
with analysis of biological material for substance use and appropriate training
and/or experience in forensic applications of analytical toxicology, e.g.
publications, court testimony, research concerning analytical toxicology of
drugs of abuse or other factors to qualify the individual as an expert witness
in forensic toxicology.
2. The director must participate in the daily
management and operation of the laboratory. The director is responsible for
ensuring that there are sufficient personnel with adequate training and
experience to supervise and conduct the work of testing laboratory, and that a
complete, signed and dated procedure manual and adequate quality assurance
programs are in place. If the director is not a full-time employee, at least
one certifying officer must have equivalent qualifications.
E. The laboratory must designate
one or more certifying officer(s), who may be the director. The certifying
officer(s) must be (a) full time employee(s). The certifying officer(s) must be
qualified in both formal training and laboratory experience, for performance
and supervision of substance use testing. A certifying officer must review the
standards, blanks and quality control data together with the screening and
confirmation test results. Upon assurance that all results are acceptable, the
certifying officer certifies the test result or results before
reporting.
F. A supervisor must be
on the premises at all times that testing is being performed. Supervisors must
possess at least a baccalaureate degree in chemistry, biochemistry or other
physical or biological science, have received at least 20 semester hours of
training in chemistry. The supervisor must have training in the theory and
practice of the procedures used and an understanding of quality control
concepts. The supervisor must have two or more years of experience in the
principles and practices of toxicology and demonstrate competency annually.
This may be accomplished through proficiency testing and/or earning 8 hours
continuing education credits specific to toxicology.
G. Other technical and non-technical staff
must possess the necessary training and skills for the task assigned. Personnel
files must include the following: resume of training and experience;
certification or license, if any; references; job descriptions; records of
performance evaluation and advancement; and incident reports. Tests for color
blindness must be administered and documented where necessary for the assurance
of proper work.
H. The laboratory
must have clear written procedures describing the chain of custody of all
samples, the security requirements for all sections of the laboratory,
including the security of record keeping, and for all laboratory testing
procedures and qualify assurance procedures. Screening and confirmatory methods
of testing and assessing specimen integrity must be as provided by law, except
that alternative screening methodologies may be approved by the Department upon
written application by the laboratory. The Department will respond to such
application within 30 days.
I. The
laboratory must demonstrate satisfactory performance in the proficiency testing
program of the National Laboratory Certification Program or the College of
American Pathologists Forensic Drug Testing for each substance of use for which
testing services are offered and a proficiency testing program is available.
1. Documentation of enrollment in an approved
proficiency testing program and copies of results must be provided annually to
the Health and Environmental Testing Laboratory (HETL) by the licensed
laboratory.
2. Satisfactory
performance is defined as follows:
a. For each
survey, achieving an 80 percent accuracy rate with no false
positives.
b. Perform
satisfactorily for two of every three consecutive surveys.
c. For consecutive surveys, achieve an
accuracy rate on each substance of 66 and 2/3 percent with no false
positives.
d. Prior to initial
licensure, achieve an 80 percent accuracy rate with no false positives for two
consecutive surveys.
3.
All unsatisfactory results must be investigated to determine the cause of the
unsatisfactory result. In those instances where a false positive result was
reported, a retrospective investigation of client specimen records must take
place to determine if similar errors had occurred. This investigation must be
documented and a copy of that documentation, along with a plan of corrective
action must be submitted to the Department within 10 working days of the
laboratory's receipt of the survey results.
4. Records must be maintained indicating that
proficiency samples are processed as routine specimens, must identify the
analyst performing the test and indicate supervisory review and corrective
action for unsatisfactory results. All records are subject to review by the
Department.
5. At the discretion of
the Department, all laboratories are subject to on-site proficiency testing at
any time tests are normally performed. Performance criteria will be as
specified in this rule.
6. If a
laboratory does not perform satisfactorily as defined in Section
4 (I)(2) of this
rule, it may be subject to loss of its license to perform testing for
substances of use, in general, or for the unsatisfactory analyte, pursuant to 5
MRS chapter 375, sub-chapter 5, until two successive surveys have been
satisfactorily tested.
7. If a
laboratory fails to comply with Section
4(1) paragraphs 3, 4
or 5 it may be required to file a documented plan of correction within 10 days,
may be subject to conditional licensure, may lose its license to test for
specific analytes or may lose its license to perform testing for substances of
abuse, pursuant to 5 MRS chapter 375, sub-chapter 5.
J. The laboratory must have a quality
assurance program which encompasses all aspects of the testing process,
including: specimen acquisition, chain of custody, security, and reporting of
results, in addition to the screening and confirmation analytical procedures.
1. Quality control procedures will be
designed, implemented and reviewed to monitor the conduct of each step of the
process. These records must be made available for review at the time of
laboratory inspections.
2. Control
urine specimens containing no drugs, and specimens fortified with known
standards, will be analyzed with each and every batch of specimens screened.
Control specimens must comprise a minimum of 10 percent of each day's processed
specimens. Some controls with added drug or metabolite at or near the threshold
(cutoff) level will be included. In addition, internal controls blind to the
analyst must be tested daily and documented by the supervisor. Implementation
of procedures to ensure that carry-over does not contaminate the testing of a
subject's specimen must be documented.
3. Quality control procedures must include
validation of the performance of all automated sample processing and data
processing equipment. Records must be maintained concerning the repair and
maintenance of all equipment.
K. Security measures must be maintained by
the laboratory to ensure that access to areas where specimens are stored and
processed, and where records are stored is strictly limited to authorized
individuals only.
L. When specimens
are received by the laboratory, receipts will be given, and the internal chain
of custody will be established. The chain of custody must document the time,
date and purpose each time the specimen is handled or transferred, and identify
the individuals involved.
M. All
non-negative specimens must be retained in the original containers in secure
storage for at least 12 months. Oral fluid and urine specimens must be stored
frozen (-20° C or below). Hair specimens may be stored at room temperature.
Should legal challenge occur, the specimen will be retained throughout the
period of resolution of the challenge. All negative samples must be disposed of
within three days of testing.
N.
All laboratory reports, including the screening, confirmation and quality
control data must be reviewed by a certifying officer before being certified as
accurate. The report must identify the name of the laboratory, the drugs and
metabolites tested for, whether the test results were negative or confirmed
non-negative, and the cutoff levels for each substance.
a. Unless agreed upon by the employee or
applicant, no report may show the quantity of substance detected, but only the
presence or absence of that substance relative to the cutoff level.
b. No report may show that a substance was
detected in a screening test, unless the presence of the substance was
confirmed in the confirmatory test. Procedures must be in place to ensure that
an applicant or employee's unconfirmed non-negative screening test result
cannot be determined by the employer in any manner, including, but not limited
to, the method of billing the employer for the tests and the time within which
results are provided to the employer.
c. No substance may be reported as present if
the employer requesting the testing did not request analysis for that
substance.
d. Reports of samples
segregated at the request of the applicant or employee for testing by a
laboratory selected by the applicant or employee must be provided to both the
employer and the applicant or employee.
O. A laboratory aggrieved by any decision of
the Department regarding approval has the rights of appeal specified in the
Maine Administrative Procedure Act, 5 MRS ch. 375, and the Administrative
Hearings Regulations, 10-144 CMR chapter 1.
