Clinical Laboratory Operations
This course will enable the lab professional to understand
The different kinds of clinical labs
Licensing, certification, and accreditation processes
What constitutes “qualified personnel”
Quality Assessment and Quality Control
Lab Safety and Ethics
Lab instruments and validation of lab tests
(FDA) Approved clinical lab tests vs lab developed tests (LDTs)
Inspection processes by government agencies and accrediting organizations
About Clinical Laboratory Operations
This course is an overview of the basic components of clinical laboratory operations and provides a general guide, from government requirements for licensing and certification, to laws and regulations regarding lab procedures and practice. While this presentation is based upon the “American Model” of lab operations, the author has found that there are elements that are common to all labs that must be addressed world-wide. Appropriate utilization of lab tests has a significant impact on patient safety and treatment, as more than 70% of all medical diagnosis and treatments (in the U.S.A.) are based on lab test results. It is important that the lab collaborates with physicians and other health care providers in the interpretation of lab testing results so that the physician can use the test result appropriately in the context of the patient’s clinical presentation, physical examination, and medical history.
While this course is geared toward providing scientists with an overview of lab operations and regulation, it will also be of benefit to lab directors, managers, and experienced personnel working in clinical labs. In addition, researchers who are developing clinical lab tests on human specimens that may one day be offered as clinical diagnostic tests will also benefit.
Victoria Shahrzad Radahd, CLS, MSc, PhD: Vice President and Chief Financial Officer
Shahrzad has more than 30 years experience in the clinical laboratory field. Worked for 15 years as a federal (CLIA) and California state clinical laboratory inspector and manger of the CLS Continuing Education and Medical Laboratory Technician programs. Worked manager of the Quality Improvement and Quality Control Programs at Berkeley HeartLab, Inc., a subsidiary of Celera Genomics/Quest Diagnostics, she led CAP inspection teams in performing laboratory inspections under the CAP Laboratory Evaluation Program.