Clinical Laboratory Compliance and Point of Care Testing Quiz

Clinical Laboratory Compliance and Point of Care Testing

• False negative (FN) is an error where something false is considered true, impacting clinical specificity and sensitivity.
• The Point of Care Coordinator (POCC) manages instrument compliance with regulations in clinical laboratories.
• The Medical Director, typically the Laboratory Director, holds final responsibility for testing at the site certification.
• The Centers for Medicare & Medicaid Services (CMS) oversee the quality and safety of U.S. clinical laboratories through CLIA regulations.
• Proficiency testing involves sending samples of unknown values to evaluate the site's performance against the central laboratory 2-3 times annually.
• Compliance in clinical laboratories involves various aspects such as validation, training, record retention, reagent management, and quality management.
• Validation of instruments for reference intervals and method correlation requires a minimum of 10 tests of each level of Liquid Quality Control (LQC).
• Calibration is the process of aligning the output delivered by a measurement device with the value of the applied standard of known accuracy.
• Point of Care Testing (POCT) involves tests performed at or near a patient where care is provided, yielding quick results for immediate action.
• POCT devices are used to improve clinical outcomes, reduce operation time, bleeding, and blood transfusions, and enhance patient care.
• Limitations of POCT devices include potential inaccuracies in blood gas and glucose readings, especially in cases of impaired peripheral circulation.
• Various Point-of-Care Analyzers and In-Line Blood Gas Analyzers are used for different purposes, such as monitoring anticoagulation and hemostasis management.

Clinical Diagnosis and Laboratory Testing: Key Concepts

• Diagnosis can be made through clinical signs and symptoms or laboratory tests
• Rule out or rule in disease refers to the ability of a diagnostic test to confirm or exclude a disease
• Confirm diagnosis is the final diagnosis made after receiving test results
• Therapy aims to treat, control, lessen symptoms, or cure a health problem
• Specimen collection for biochemical tests requires proper labeling and patient information
• Serum and plasma are two types of specimens collected for testing
• Hemolysis is the rupture or destruction of red blood cells and can be caused by intrinsic or extrinsic factors
• Intrinsic factors causing hemolysis include hereditary conditions and abnormalities in red blood cell structure
• A case history example demonstrates abnormal blood test results and a hemolyzed sample
• Accuracy, precision, sensitivity, and specificity are essential for analytical methods used in lab testing
• Sources of error in lab testing include preanalytical, analytical, and postanalytical factors
• Clinical specificity and sensitivity are measures of the accuracy of a test in identifying positive and negative results for a disease