If you have ever had a lab test, you may have wondered, what exactly goes into producing an accurate, timely test result. You may have also wondered, are there any third-party “watchdogs” to ensure laboratory quality.
Clinical laboratory testing involves a complex web of scientific and medical expertise, technological innovation, and logistical know-how. Reliable lab testing is an extremely important component of a patient’s health journey. Physicians rely on results of lab tests to make most healthcare decisions on behalf of patients.
Recently, Quest Diagnostics achieved a major milestone in laboratory quality. The College of American Pathologists (CAP), a Centers for Medicare and Medicaid Services (CMS)-approved accreditation authority, awarded the company’s advanced clinical laboratory in San Juan Capistrano, California, ISO15189 accreditation.
Quest Diagnostics Nichols Institute, focuses on specialized and highly complex laboratory testing, such as next generation sequencing and other advanced diagnostics, and plays a key role in Quest Diagnostics research and development efforts. Performing tests often not found in most routine or hospital laboratories, Nichols Institute has deep expertise in a range of subspecialties including cancer, endocrinology, genetics and personalized medicine, infectious diseases and more.
The accreditation is based on the International Organization for Standardization (ISO) 15189 Standard for medical laboratories’ technical competence, management, and continual improvement. It focuses
on improved patient safety and risk reduction, outlining standards for quality, and competence particular to medical laboratories, creating a framework for achieving and sustaining a world class level of quality management and continuous improvement, Completely voluntary in the US, the CAP 15189 accreditation program complements CAP’s Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program.
“The tests we develop and perform at Quest Diagnostics Nichols Institute in San Juan Capistrano drive health and treatment decisions for some of the most challenging healthcare issues our patients faces, so quality is essential,” said Katie Bishar, Vice President, Esoteric Operations, Quest Diagnostics. “As the world’s leading diagnostic information services company, we are proud to be recognized as leaders in achieving this mark of quality, which aligns with our goal to advance patient care. We thank our employees in San Juan Capistrano for committing to the high quality standards that helped us earn this accreditation.”
Quest has a track record of outstanding quality, and several of our other labs outside of the US have earned ISO15189 accreditations, including Mexico City and Gurgaon, India.
“The ISO15189 Standard provides a comprehensive quality management framework that allows laboratories not only to ‘study for the exam’ but also to ‘learn for life’”, said Frank Schneider, MD, FCAP, and Chair of the CAP 15189 Committee. “Laboratories working towards its implementation have chosen a path of continual improvement. They embrace their problems and seek intelligent solutions, thereby enhancing patient care as well as customer and staff satisfaction.”