The Growing Role of Quality Management Systems In Clinical Laboratory Accreditation and Licensure

CLIA inspections are growing tougher every year. It’s the same story with Medicare accreditation of clinical laboratories. Requirements are tightening. Onsite Lab inspections and assessments are becoming more rigorous.

SPECIAL REPORT The Growing Role of Quality Management Systems In Clinical Laboratory Accreditation and Licensure Now more than ever, quality is a major issue in the clinical diagnostic laboratory. With a temperamental economy and major ongoing changes in federal healthcare policy, more and more pressure is coming to bear on diagnostic laboratories to justify their laboratory testing, provide reliable, accurate test results at a reasonable cost, and successfully compete for reimbursement in an aggressive market.

CLIA has set minimum guidelines  for quality that all U.S. clinical laboratories must meet in order to continue operating and receiving Medicare and Medicaid reimbursements. A Quality Management System (QMS) is one way for labs to implement processes and procedures that will meet or exceed CLIA’s minimum guidelines.

This Special Report clearly explains all the key developments, and shows you how and why the use of a Quality Management System (QMS) is such a powerful way to put your laboratory at full compliance, ready for surprise inspections that result in a “no deficiency” outcome.

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This illuminating report should be read by any laboratory manager or clinical diagnostic leader interested in laboratory quality. It will provide resources and the information needed to make critical decisions about laboratory processes, quality initiatives, and the adoption of a Quality Management System to achieve Total Quality Management and meet CLIA accreditation standards.



Judith Yost, MA, MT(ASCP)

Director, Division of Laboratory Services at the Centers for Medicare
and Medicaid Services, CMS

Baltimore, MD

Lucia Berte, MA, MT(ASCP), CMQ/OE(ASQ)

President, Laboratories Made Better! P.C.

Broomfield, CO

James H. Nichols, Ph.D., DABCC, FACB

Medical Director, Baystate Health

Springfield, MA

Elissa Passiment, Ed.M., CLS(NCA)

Executive Vice-President, American Society for Clinical Laboratory Science

Washington, DC

Christine D. Flaherty, MHA, MT(ASCP), CPHQ

Regional Laboratory Director, Sutter Health

Sacramento, CA

Leo Serrano, FACHE DLM(ASCP)

Director, Laboratory Services for Avera McKennan Hospital & University Health Center

Sioux Falls, SD

After reading this Special Report, you’ll possess a clear understanding of the differences and similarities between CLIA certification and a Quality Management System (QMS), the various components of quality management, and how they fit into a complicated framework of national and international standards. In addition, you will appreciate how utilizing CLIA certification as a template for a continual quality process and Quality Management System can lead to a more efficient laboratory operation that positively impacts patient outcomes and laboratory economics.

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