Iowa Admin. Code r. 641-12.3 - [Effective 7/1/2025] Application procedures and requirements
Laboratories desiring to conduct confirmatory testing for Iowa's employers shall apply to the department for approval. Each laboratory requesting Iowa approval to conduct confirmatory testing shall provide the following to the department:
(1) A
completed laboratory survey checklist on a form provided by the
department.
(2) A completed
self-inspection questionnaire provided by the department.
(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.
Notes
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The
(1) Processing applications from laboratories requesting approval to conduct confirmatory testing pursuant to Iowa Code subsection 730.5(7), paragraph"e. "
(2) Developing an application package .
a. The package shall be provided to all laboratories requesting approval to conduct confirmatory testing for alcohol or other drugs, or their metabolites.
b. The package shall contain application procedures, a copy of Iowa Code section 730.5, a copy of these administrative rules, a standardized application form and a self-inspection questionnaire.
c. The self-inspection questionnaire shall assist the department in assessing the quality of a laboratory 's performance as a confirmatory testing laboratory . This questionnaire will comprise the major but not the sole objective criteria used during the initial on-site inspection when conducted by the UHL .
d. The package shall be available upon request from the Iowa Department of Public Health, Division of Health Protection, Private Sector Drug Testing Program, Lucas State Office Building, Des Moines, Iowa 50319-0075.
(3) Reviewing each application submitted and determining the adequacy for approval.
(4) Designating the UHL to conduct an on-site inspection of each approved confirmatory laboratory at least once every two years. Inspection may be waived by the director if the laboratory has been inspected and accredited for forensic drug testing by the College of American Pathologists, or if the laboratory has been inspected and certified, licensed, or approved to conduct confirmatory testing by another state whose requirements are at least equal to Iowa's.
(5) Maintaining and providing upon request an updated list of all approved confirmatory laboratories.
(6) Providing written notice of approval and assigning an expiration date.