Federal law requires any laboratory or facility that performs laboratory testing of human specimens for the purpose of diagnosis, prevention or treatment of disease to meet certain requirements, including a Clinical Laboratory Improvement Amendments (CLIA) certification. The type of CLIA certificate a laboratory must have depends on the type of testing the laboratory performs. Every two years, laboratories with certificates of compliance or accreditation are subject to routine inspections, referred to as surveys.
Under a contract with the Iowa Department of Inspections and Appeals, the Hygienic Laboratory provides personnel to conduct surveys for the Clinical Laboratory Improvement Amendment (CLIA) of 1988 programs. Since 2002, the Hygienic Laboratory also has been responsible for the administrative oversight of the CLIA laboratory program and serves as the state agency representative for the Center for Medicare and Medicaid Services CLIA program. In fiscal year 2013, Iowa had a total of 2,983 laboratories or facilities that provide testing. That is an increase of 43 from fiscal year 2012.
Major accomplishments for the Iowa CLIA surveyors include:
- 123 recertification surveys (certificates of compliance)
- 18 initial surveys (certificates of compliance)
- Eight validation surveys (certificates of accreditation)
- Three onsite follow-up/revisit surveys (certificates of compliance)
- 40 paper follow-up/revisit surveys (certificates of compliance and accreditation)
- 40 Certificate of Waiver onsite surveys
- 19 Certificate of Waiver paper follow-up/revisit surveys
- 3 onsite follow-up/revisit surveys (certificates of compliance)
- 10 proficiency testing desk reviews
- Traveled 26,173 miles