Clinical Laboratory Compliance and Point of Care Testing Quiz

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Questions and Answers

What is the purpose of laboratory testing in different patient populations?

To identify individuals at sufficient risk of a specific disorder to warrant further investigation

To match each person to a granular normal reference population for personalized medicine

To establish reference intervals for laboratory analytes based on the absence of chronic/acute disease

To gain normal values for common laboratory tests to govern the diagnosis, treatment, and overall management of tested individuals (correct)

What must be done first for the precise application of clinical laboratory testing?

Screen the whole family if one member had a specific disease

Establish reference intervals for laboratory analytes based on the absence of chronic/acute disease

Identify a 'healthy' population to estimate the normal range of variation across a population (correct)

Match each person to a granular normal reference population for personalized medicine

What does the Clinical and Laboratory Standards Institute (CLSI) guideline recommend for establishing reference intervals for laboratory analytes?

Using 120 'reference individuals' to establish reference intervals for laboratory analytes (correct)

Matching each person to a granular normal reference population for personalized medicine

Screening the whole family if one member had a specific disease

Applying tests rapidly for large-scale identification of disease

What is the role of mass screening in laboratory testing?

To conduct large-scale identification of disease using tests, examinations, or other procedures which can be applied rapidly Signup and view all the answers

What does TEG measure?

Clot stability dependent on platelets and fibrin Signup and view all the answers

Which TEG value suggests the need for cryoprecipitate?

Decreased alpha angle Signup and view all the answers

What does the Sonoclot Analyzer measure?

Coagulation and platelet function Signup and view all the answers

Which test is sensitive to aspirin and clopidogrel?

Platelet mapping with TEG-PM Signup and view all the answers

What do antiplatelet drugs like Abciximab inhibit?

Platelet activation Signup and view all the answers

What is the gold standard test for diagnosing platelet function disorders?

Platelet aggregometry Signup and view all the answers

What are the key variables for ROTEM equivalent to?

Key variables for TEG Signup and view all the answers

What does adding an agonist to the suspension in platelet aggregometry involve?

Recording platelet clumping Signup and view all the answers

What does increased R time in TEG suggest the need for?

FFP Signup and view all the answers

What are TEG and ROTEM?

Two different viscoelastic tests Signup and view all the answers

What activates platelets?

Subendothelial macromolecules Signup and view all the answers

What does the VerifyNow test measure?

Whole blood aggregometry Signup and view all the answers

What is the role of the Point of Care Coordinator (POCC) in clinical laboratories?

Managing instrument compliance with regulations Signup and view all the answers

Who holds final responsibility for testing at the site certification in clinical laboratories?

The Medical Director Signup and view all the answers

Which organization oversees the quality and safety of U.S. clinical laboratories through CLIA regulations?

Centers for Medicare & Medicaid Services (CMS) Signup and view all the answers

How often is proficiency testing typically conducted in clinical laboratories?

2-3 times annually Signup and view all the answers

What is the process of aligning the output delivered by a measurement device with the value of the applied standard of known accuracy called?

Calibration Signup and view all the answers

What is the primary purpose of Point of Care Testing (POCT) in clinical settings?

Yielding quick results for immediate action Signup and view all the answers

What are the limitations of Point of Care Testing (POCT) devices?

Potential inaccuracies in blood gas and glucose readings Signup and view all the answers

What is the minimum number of tests of each level of Liquid Quality Control (LQC) required for validation of instruments for reference intervals and method correlation?

10 tests Signup and view all the answers

What is the primary purpose of Point of Care Testing (POCT) devices?

To improve clinical outcomes and enhance patient care Signup and view all the answers

What is the role of the Medical Director in clinical laboratories?

Holding final responsibility for testing at the site certification Signup and view all the answers

What is involved in compliance in clinical laboratories?

Validation, training, record retention, reagent management, and quality management Signup and view all the answers

What is the primary purpose of Point-of-Care Analyzers and In-Line Blood Gas Analyzers in clinical settings?

Monitoring anticoagulation and hemostasis management Signup and view all the answers

What does hemolysis refer to?

Rupture or destruction of red blood cells Signup and view all the answers

What is the final diagnosis made after receiving test results called?

Confirm diagnosis Signup and view all the answers

What are serum and plasma examples of?

Specimens collected for testing Signup and view all the answers

What are accuracy, precision, sensitivity, and specificity essential for in lab testing?

Analytical methods Signup and view all the answers

Which factors can cause hemolysis?

Intrinsic and extrinsic factors Signup and view all the answers

What does therapy aim to do in the context of health problems?

Treat, control, lessen symptoms, or cure Signup and view all the answers

What are the types of errors in lab testing?

Preanalytical, analytical, and postanalytical factors Signup and view all the answers

What are accuracy and sensitivity measures of in lab testing?

Measures of the accuracy of a test in identifying both positive and negative results Signup and view all the answers

What is the ability of a diagnostic test to confirm or exclude a disease called?

Rule out or rule in disease Signup and view all the answers

What is specimen collection for biochemical tests required to have?

Proper labeling and patient information Signup and view all the answers

What are intrinsic factors causing hemolysis related to?

Hereditary conditions and abnormalities in red blood cell structure Signup and view all the answers

What are clinical specificity and sensitivity measures of in lab testing?

Measures of the accuracy of a test in identifying positive and negative results for a disease Signup and view all the answers

Study Notes

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

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Description

Test your knowledge of clinical laboratory compliance and point of care testing with this quiz. Explore key concepts such as false negatives, proficiency testing, compliance regulations, and the role of the Point of Care Coordinator. Gain insights into the importance of accuracy, precision, sensitivity, and specificity in laboratory testing, as well as the limitations and benefits of point of care testing devices.