Iowa Admin. Code r. 641-12.4 - [Effective 7/1/2025] Requirements of laboratory personnel involved in confirmatory testing for alcohol or other drugs, or their metabolites
(1) The laboratory
director shall be a pathologist or doctoral level individual who qualifies as a
clinical laboratory director under CLIA regulations.
(2) Supervisors of analysts shall possess at
least a bachelor of science degree in chemistry, medical technology, or
comparable education and two years of analytical alcohol or drug testing
experience. Supervisors must also have training in the theory and practice of
laboratory procedures and an understanding of quality control concepts. Annual
verification of the supervisor's skills must be documented by the laboratory
director.
(3) Analysts shall
possess the necessary training and skills for assigned tasks. These individuals
shall possess at least two years of college education in the physical or
biological sciences. At a minimum, analysts shall be graduates of a medical
laboratory technician program that is recognized by the department or have at
least two years of college with a minimum of nine semester hours in
chemistry.
(4) Laboratory
directors, supervisors and analysts involved in alcohol or drug testing shall
annually complete at least one in-service continuing education program related
to alcohol or drug testing. Continuing education programs include formal
training programs where continuing education units are awarded, informal
in-house training programs, and relevant correspondence courses. Dates, titles
and subject matter for each completed course shall be documented and the
information shall be available for review.
(5) The following information about each of
the laboratory staff involved in alcohol or drug testing shall be retained for
two years from date of termination and shall be available for review:
a. Résumé of training and
experience.
b. Certificate or
license.
c. Job
description.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
Laboratories desiring to conduct confirmatory testing for Iowa's employers shall apply to the
(1) A completed laboratory survey checklist on a form provided by the department .
(2) A completed self-inspection questionnaire provided by the department that includes:
a. A list of alcohol or other drugs, or their metabolites, being tested.
b. Copies of the two most recent and relevant graded proficiency test reports from a recognized proficiency testing program.
c. Personnel qualifications for all staff involved in the technical and administrative management of the alcohol or drug testing laboratory .
d. Copies of the forms used to report test results.
e. Chain of custody protocols and copies of the chain of custody forms used.
f. Sample collection procedures.
g. Confirmation procedures.
(3) Proof of enrollment in a recognized proficiency testing program. Recognized programs include those approved by CMS .
(4) Acceptable performance over a 12-month period in all appropriate areas of proficiency testing for alcohol or other drugs, or their metabolites, shall be documented and maintained on an ongoing basis. Acceptable performance is as follows:
a. Initial approval shall require at least 80 percent accuracy in the last two graded proficiency test cycles with no false positive results.
b. Renewal shall require at least 80 percent accuracy each year on graded proficiency surveys with no false positive results.