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CLIA Certification

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.  The objective of the CLIA program is to ensure quality laboratory testing.  Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.  For more information go to www.cms.gov/clia/.

The Missouri State Public Health Laboratory (MSPHL) is a high complexity laboratory that is certified every two years.  Please see CLIA certificate below. 

For inquiries regarding a facility CLIA Certificate please contact the DHSS Division of Regulation and Licensure, Section of Health Standards and Licensure at 573-751-6318.

AIHA-LAP, LLC Accredited

The MSPHL participates in the Environmental Lead Laboratory Accreditation Program (ELLAP) for their environmental lead program and is accredited by the American Industrial Hygiene Association® Laboratory Accreditation Program (AIHA-LAP, LLC) every two years.

AIHA Laboratory Accreditation Programs (AIHA-LAP, LLC) is a group of laboratory accreditation programs. The primary mission of AIHA-LAP, LLC is to establish high standards of performance for laboratories that promote the production of quality data for use in evaluating exposures that impact public health, the environment and natural resources. These programs are administered in a non-discriminatory manner and are open to all laboratories wishing to participate. Access to AIHA-LAP, LLC programs is not conditional upon the size of the laboratory or organization seeking accreditation, nor are there undue financial conditions to restrict participation. Accreditation is granted to any laboratory satisfying AIHA-LAP, LLC requirements for accreditation.

The Environmental Lead Laboratory Accreditation Program (ELLAP) accredits laboratories performing analysis of lead in environmental samples including paint, soil, dust wipes and air. The ELLAP is recognized by the Environmental Protection Agency (EPA) through a Memorandum of Understanding and this program has been designed to comply with the requirements of the EPA National Lead Laboratory Accreditation Program (NLLAP). AIHA-LAP, LLC also has a Memorandum of Understanding with the State of Georgia. It is standard practice for AIHA-LAP staff to meet regularly with representatives of EPA NLLAP, and the State of Georgia to collaborate on means of continuously improving the AIHA-LAP, LLC accreditation programs and the relationship between the signatory parties.

For more information, go to http://www.aihaaccreditedlabs.org/Pages/default.aspx.

See AIHA-LAP, LLC accreditation below:

ISO/IEC 17025:2005 Accredited

The MSPHL food microbiological testing program has several methods accredited to the ISO/IEC 17025:2005 standard thru Perry Johnson Laboratory Accreditation, Inc. ISO/IEC 17025:2005 is an International Standard designed for the accreditation of Testing Laboratories. It includes quality management system requirements along with technical requirements to ensure that each laboratory is equipped to perform particular tests activities. The objective of the participating in this accreditation program is to ensure quality laboratory testing in support of state or federal food safety surveillance programs.

For more information, go to: http://www.pjlabs.com/search-accredited-labs

See Perry Johnson Laboratory Accreditation, Inc. below:

EPA Certification

All public water supplies are required by the federal Safe Drinking Water Act to monitor their water quality through monthly testing for bacteria. These compliance samples must be tested by a US EPA or State certified laboratory. The MSPHL serves as the primary bacterial testing laboratory for public water supplies in Missouri. The MSPHL performs this testing in conjunction with the Missouri Department of Natural Resources (DNR) Public Drinking Water Branch (PDWB).

The MSPHL is certified by the US EPA Region 7 Office in Kansas City, Kansas to perform bacterial testing of public drinking water samples.

Milk Laboratory Certification Program

The MSPHL is the official agency for certification of milk-testing laboratories. The certification program is managed by the Milk Laboratory Evaluation Officer under Missouri’s code of state regulations and the US FDA’s Evaluation of Milk Laboratories Program. The Laboratory Evaluation Officer evaluates and accredits milk laboratories and screening sites throughout the state, and certifies analysts who examine milk supplies for interstate shipment.  Biennial audits are made to determine if milk laboratories and antibiotic screening facilities are producing reliable, valid and verifiable test data. These laboratories provide official testing results to the Missouri State Milk Board, which serves as the official milk regulatory agency in Missouri.

For further information, click on the external links below, or contact the Laboratory Evaluation Officer:

Mr. Leon Luebbering
Missouri Department of Health and Senior Services
State Public Health Laboratory
101 North Chestnut Street
Jefferson City MO 65101
Phone: 573-751-3334
FAX: 573-522-4032
Email: Leon.Luebbering@health.mo.gov

External Links

Code of State Regulations
FDA Milk Safety References EML & PMO
FDA's 2400 evaluation forms
Missouri State Milk Board

Drinking Water Microbiology Laboratory Certification Program

Laboratories that test drinking water samples from public water supplies must be certified by the Missouri Department of Natural Resources (DNR), Public Drinking Water Branch. Testing is for compliance with the state and federal Safe Drinking Water Act and the Total Coliform Rule. Requirements for laboratory certification are listed in the US EPA Manual for the Certification of Laboratories Analyzing Drinking Water, Criteria and Procedures, Quality Assurance, 5th Edition, 2005; Chapter 5: Microbiology.
The State Public Health Laboratory provides staff who serve as Laboratory Certification Officers (LCO’s) for the DNR’s drinking water microbiology laboratory certification program. LCO’s perform on-site evaluations of laboratories requesting certification through DNR’s program. Certification renewal is based on triennial on-site evaluations, and successful performance on annual proficiency tests.

For further information, click on the external links below, or contact the Laboratory Certification Officer:

Ms. Ashley Mehmert
Missouri Department of Health and Senior Services
State Public Health Laboratory
101 North Chestnut Street
Jefferson City MO 65101
Phone: 573-751-3334
FAX: 573-522-4032
Email: Ashley.Mehmert@health.mo.gov

External Links

DNR Public Drinking Water Branch
EPA Laboratory Certification Program and Manual
EPA Safe Drinking Water Act Information Page
EPA Total Coliform Rule Information Page