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Certificate of Waiver Laboratory Project

Certificate of Waiver Project

For many Americans, the accuracy of clinical laboratory test results can mean the difference between life and death. For example, a clinical laboratory's incorrect reading of a patient's cholesterol level could stop that patient from receiving the necessary treatment for preventing a heart attack. To better encourage quality laboratory testing, in April 2002, CMS initiated on-site visits to approximately 2% of laboratories that have been issued a certificate of waiver (CoW) under the Clinical Laboratory Improvement Amendment (CLIA)  This is the first time that CMS has conducted educational visits in all 50 states, though two previous studies did include visits to a smaller number of states. 

These visits are announced, information gathering and are designed to help educate the laboratories on sound laboratory practices.  The State agency surveyors will ensure that personnel conduct quality testing in a manner which protects patient safety, determine each laboratory's regulatory compliance, and make certain that each laboratory is only conducting the more simple tests that are appropriate for a certificate of waiver facility.  If problems are uncovered, the surveyors will provide education and assistance to the laboratories to help them achieve more accurate, reliable and timely test results.

Information about these visits was sent to the laboratory community, including State survey directors and medical and laboratory professional organizations.  The information included the following (listed as a download below): a FACT sheet, the letter sent to the participating laboratories, and the questions the surveyor uses during the visit.  Preliminary follow-up data from the expanded pilot study indicates that the education provided during these on-site visits is effective.

CMS will continue to visit two percent of these laboratories throughout the United States each year.  Through a partnership with laboratory professional and accrediting organizations, manufacturers, states, the CDC, the FDA, and the educational community, we will ensure that CoW laboratories can receive the education needed to achieve accurate and reliable test results, and ultimately improve the quality of health care.

Requirements for Waived Tests

To receive a certificate of waiver under CLIA, a lab must only perform tests like the glucose meter test which the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined to be so simple that there is little risk of error. In addition, these tests are exempted from most CLIA requirements and the laboratories that perform them receive no routine inspections.

Waived laboratories must meet only the following requirements under CLIA:

  • Enroll in the CLIA program;
  • Pay applicable certificate fees biennially; and
  • Follow manufacturers' test instructions.

The types of tests waived under CLIA has increased from 8 to approximately 100 tests since the inception of the program in 1992; thereby, the number of laboratories issued a CoW has grown exponentially from 20% to 69% of the approximate total of the 236,000 laboratories enrolled.

Good Laboratory Practices for Waived Testing Sites Report

On November 11, 2005, the CDC published the report called "Good Laboratory Practices for Waived Testing Sites" in the Morbidity and Mortality Weekly Report (MMWR).  This report summarized study findings and provided recommendations developed by the Clinical Laboratory Improvement Advisory Committee (CLIAC) for conducting quality waived testing.  This report can be found below as a related link outside CMS.