BSMT/NU MED 221 Year 2: Laboratory Quality Management System

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Questions and Answers

What is the purpose of a Quality Management System in a laboratory?

  • To coordinate activities and control the organization with regard to quality (correct)
  • To set standards for laboratory operations
  • To guide the organizations towards financial success
  • To minimize personnel effort in the laboratory

Which organizations set standards for laboratory operations?

  • ISO and CLIA (correct)
  • NIST and OSHA
  • WHO and CDC
  • FDA and EPA

What are the consequences of inaccurate results in the laboratory?

  • Increased patient complications and longer medication (correct)
  • Reduced personnel effort in the laboratory
  • Improved patient outcomes
  • No impact as long as the treatment is started

Which part of the laboratory workflow involves Sample Collection?

<p>Pre examination (B)</p> Signup and view all the answers

What is the purpose of Record Keeping in a laboratory?

<p>To maintain a history of laboratory activities for reference (D)</p> Signup and view all the answers

What are the three phases in the workflow of a health laboratory?

<p>Sample collection, sample transport, releasing and interpretation of results (D)</p> Signup and view all the answers

What does achieving a 99% level of quality mean in terms of error rate?

<p>1% error rate (C)</p> Signup and view all the answers

What are the essential characteristics of laboratory results?

<p>Accurate, reliable, and timely (A)</p> Signup and view all the answers

What is considered the most important resource in a laboratory for productivity?

<p>Competent and motivated personnel (A)</p> Signup and view all the answers

What is the purpose of the Quality Policy in an organization?

<p>To integrate the mission, vision, and core values for quality commitment (D)</p> Signup and view all the answers

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Study Notes

Quality Management System in a Laboratory

  • The purpose of a Quality Management System (QMS) in a laboratory is to ensure the quality of laboratory results and services.

Standard-Setting Organizations

  • Organizations that set standards for laboratory operations include ISO (International Organization for Standardization) and CAP (College of American Pathologists).

Consequences of Inaccurate Results

  • Inaccurate results in the laboratory can lead to misdiagnosis, wrong treatment, and harm to patients, as well as legal and financial consequences.

Laboratory Workflow

  • The pre-analytical phase of the laboratory workflow involves Sample Collection.
  • The three phases in the workflow of a health laboratory are: • Pre-analytical phase (sample collection and preparation) • Analytical phase (testing and analysis) • Post-analytical phase (result interpretation and reporting)

Record Keeping in a Laboratory

  • The purpose of Record Keeping in a laboratory is to maintain a complete and accurate record of laboratory data, including testing, results, and quality control.

Achieving a 99% Level of Quality

  • Achieving a 99% level of quality means that the laboratory has a 1% error rate or 1 error per 100 tests.

Characteristics of Laboratory Results

  • The essential characteristics of laboratory results include accuracy, precision, sensitivity, specificity, and reproducibility.

Most Important Resource in a Laboratory

  • The most important resource in a laboratory for productivity is a qualified and competent workforce.

Purpose of the Quality Policy

  • The purpose of the Quality Policy in an organization is to establish a framework for quality objectives and ensure a commitment to quality.

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