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SECTION I: INTRODUCTION TO ACCREDITATIONGot a Question About Accreditation? Need More Information?Here’s How to Contact COLA and Get Help Fast…COLA’s experts are readily available to help you. Never hesitate to contact COLA for information and help on accreditationor any other COLA service.By Internetwww.cola.orgFind more information about COLA and get educational resources and updates on laboratory topics. This also is where youwill find the COLA Member Site.By E-Mail:info@cola.orgWrite us with your specific accreditation questions, which will be directed toward members of the COLA staff.By Phone:Contact the Call Center at (800) 981-9883.Ask COLA staff about accreditation, educational products, and laboratory related issues.By Regular Mail:Write to us at: Accreditation Division, COLA, 9981 Broken Land Parkway, Suite 200, Columbia, MD 21046LabUniversity ® :www.labuniversity.orgObtain information about on-line training courses that can enhance your laboratory knowledge and provide continuingeducation credit.1-4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
SECTION I: INTRODUCTION TO ACCREDITATION>COLA, Regulatory Compliance,and Your LaboratoryBackgroundWhen Congress passed the Clinical Laboratory ImprovementAmendments of 1988 (CLIA), a new era of laboratory regulation wasimplemented. CLIA established quality standards for all diagnosticlaboratory testing to ensure the accuracy, reliability, and timelinessof patient test results.Management and operation of the CLIA program was assigned tothe Centers for Medicaid and Medicare Services (CMS), a branchof the U.S. Department of Health and Human Services. Today,CMS regulates all laboratory testing “for the purpose of providinginformation for the diagnosis, prevention, or treatment of any diseaseor impairment of, or the assessment of the health of humans.”Key Terms inRegulationCLIA — Clinical LaboratoryImprovement Amendments of1988 established quality standards forall laboratory testing in the UnitedStates.CMS — Centers for Medicaid andMedicare Services. CMS regulates alllaboratory testing “for the purposeof providing information for thediagnosis, prevention, or treatment ofany disease or impairment of, or theassessment of the health of humans.”How COLA OperatesWithin the Regulatory StructureA landmark moment in COLA history was the decision by federalrule makers to allow private accrediting organizations likeCOLA to work within the regulatory structure as an alternativeto direct federal government oversight and inspection by CMS.As a result of this action, COLA was approved by CMS as a private,non-profit accrediting organization for CLIA purposes. Thus, when alaboratory applies to COLA and is granted accreditation, CMSrecognizes the lab as meeting CLIA requirements.COLAAccreditationInterrelationships between Lab, CLIA & COLA >OtherAccreditationOrgsLABStateCLIA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org1-5
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