2 - Quality Management in Laboratory Safety

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Questions and Answers

What is the primary goal of quality control in a clinical laboratory?

  • Maintaining the aesthetic appeal of the laboratory setting.
  • Ensuring the safety of laboratory personnel.
  • Producing accurate, reliable, and timely test results. (correct)
  • Minimizing the cost of laboratory testing.

According to the definition provided, what does quality control involve?

  • The elimination of all possible errors in a process.
  • Only the use of statistical analysis for process monitoring.
  • Solely the inspection of final products.
  • An aggregate of activities like design analysis and inspection. (correct)

Which of the following best describes the scope of ISO 9000's definition of 'quality control'?

  • The use of external audits to assess laboratory performance.
  • Operational techniques and activities used to fulfill quality requirements. (correct)
  • The process of identifying defective products after manufacturing.
  • A set of rules dictating laboratory personnel attire and conduct.

The Levey-Jennings chart is used in quality control to monitor:

<p>The performance and stability of laboratory tests. (D)</p> Signup and view all the answers

What is the significance of establishing control rules (e.g., using a Westgard Multirule System) within quality control?

<p>To determine when to reject analytical runs based on control sample results. (D)</p> Signup and view all the answers

What action should be taken when 'out of control' values are observed in a quality control process?

<p>Investigation to identify the source of the problem and corrective actions. (C)</p> Signup and view all the answers

Why is timely reporting of results significant in quality control?

<p>To support prompt medical decisions and patient care. (C)</p> Signup and view all the answers

Which hazard control method involves altering work habits to reduce exposure?

<p>Administrative controls (D)</p> Signup and view all the answers

Which of the following provides the LEAST effective method for controlling laboratory hazards?

<p>Personal protective equipment (D)</p> Signup and view all the answers

What is the purpose of face protection like facemasks in a laboratory setting?

<p>To block large-particle droplets and splashes from reaching the mouth and nose (A)</p> Signup and view all the answers

What prompted the introduction of universal precautions in laboratories?

<p>Growing concern about occupational exposure to HBV and HIV (A)</p> Signup and view all the answers

According to the guidelines, what is the most important source of HIV and HBV in the laboratory setting?

<p>Blood (C)</p> Signup and view all the answers

In a Levey-Jennings chart, what does a shift indicate?

<p>An abrupt change followed by at least six consecutive quality control results falling on one side of the mean. (A)</p> Signup and view all the answers

What is the primary cause of a shift in a Levey-Jennings chart?

<p>Improper calibration of the instrument (C)</p> Signup and view all the answers

When interpreting a Levey-Jennings chart using a single control, what action should be taken if the control value falls outside ±2 SD?

<p>Reject the run and investigate the cause. (C)</p> Signup and view all the answers

When using the Westgard Multirule system, what initial action should be avoided after a rule violation?

<p>Repeating the testing without investigating the cause. (B)</p> Signup and view all the answers

What is the purpose of the lines drawn horizontally at ±1, 2, and 3 standard deviations (SDs) on a Levey-Jennings chart?

<p>To mark off the areas of statistical probability and assess the acceptability of control results. (B)</p> Signup and view all the answers

How is the mean typically represented on a Levey-Jennings chart?

<p>By a horizontal line in the middle of the graph (C)</p> Signup and view all the answers

What is the immediate next step if a Levey-Jennings control value falls outside of $\pm 2SD$ when using one level of control?

<p>Reject the run and investigate potential sources of error. (D)</p> Signup and view all the answers

A control value that has gone out of the $\pm 2SD$ limit indicates which of the following?

<p>Out of control situation (B)</p> Signup and view all the answers

How many consecutive QC results need to fall on the same side of the mean before a shift is identified?

<p>6 (A)</p> Signup and view all the answers

Which of the following Westgard rules indicates a systematic error?

<p>4:1S (D)</p> Signup and view all the answers

If a laboratory run violates the R4S Westgard rule, what action should be taken?

<p>Reject the results (D)</p> Signup and view all the answers

In which phase of the laboratory testing process do most errors typically occur?

<p>Pre-Analytic Phase (C)</p> Signup and view all the answers

What is a common cause of rejected samples in the pre-analytic phase?

<p>Incomplete laboratory request forms (B)</p> Signup and view all the answers

Which Westgard rule is most likely to indicate the presence of random error in an analytical run?

<p>R:4S (B)</p> Signup and view all the answers

According to the information, what percentage of rejected samples are due to 'Incomplete Laboratory Request Forms'?

<p>2/3 (D)</p> Signup and view all the answers

What does the '10X' rule indicate?

<p>Ten consecutive control results fall on one side of the mean. (B)</p> Signup and view all the answers

Which of the following errors is most likely to occur during the pre-analytic phase of laboratory testing?

<p>Wrong patient identification (C)</p> Signup and view all the answers

Which action is recommended if four consecutive control results exceed either ±1SD?

<p>Reject the results and investigate the systematic error. (D)</p> Signup and view all the answers

What steps are typically included in the Pre-Analytic Phase?

<p>Sample preparation, collection, and transport. (D)</p> Signup and view all the answers

Which action is crucial for adhering to standardized labeling protocols in a laboratory setting?

<p>Employing electronic markers (PGH) for consistent and accurate sample identification. (B)</p> Signup and view all the answers

What is a key element of staff education and training in maintaining laboratory standards?

<p>Regular reporting and feedback mechanisms to ensure compliance. (B)</p> Signup and view all the answers

Which of the following demonstrates adherence to strict laboratory protocols?

<p>Setting criteria for rejecting samples that do not meet quality standards. (D)</p> Signup and view all the answers

A sample is received in the lab that is unlabeled. Following laboratory standards, what action should be taken?

<p>Reject the sample due to non-compliance with labeling standards. (C)</p> Signup and view all the answers

What action should be taken if a blood sample is hemolyzed, depending on the test requested?

<p>Reject the sample if hemolysis interferes with the accuracy of the requested test. (B)</p> Signup and view all the answers

Why is it important to collect fasting samples for tests that require them?

<p>Fasting minimizes the influence of dietary factors on test results. (C)</p> Signup and view all the answers

A phlebotomist collects a blood sample for a test that requires a specific anticoagulant, but mistakenly uses a different tube. What is the correct course of action?

<p>Reject the sample due to collection in the wrong tube/container. (C)</p> Signup and view all the answers

Why is it important to ensure adequate sample volume when collecting blood in tubes containing preservatives?

<p>Adequate volume ensures the correct blood-to-preservative ratio, maintaining sample stability. (B)</p> Signup and view all the answers

How can ergonomic hazards in the laboratory be minimized?

<p>Providing adjustable workstations and chairs to promote good posture. (A)</p> Signup and view all the answers

What is the best way to prevent "repetitive motion injuries" in the laboratory?

<p>Taking frequent breaks and varying tasks to avoid prolonged strain on specific muscles and joints. (A)</p> Signup and view all the answers

Flashcards

Trend

A trend occurs with six or more consecutive QC results on one side of the mean.

Shift

A shift is indicated by a change followed by six QC results on one side of the XÌ„.

Mean (XÌ„)

The mean is the average value in a set of data, here XÌ„ = 190.5.

Standard Deviation (SD)

SD measures how data points deviate from the mean; here, SD = 2.00.

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+/- 2 SD

+/- 2 SD defines the acceptable control limits for quality, 188.5 to 192.5.

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Out of Control

If a control value falls outside ±2 SD, it's considered 'out of control'.

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Westgard Multirule System

A system to evaluate quality control using multiple rules for error detection.

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Control Value

The control value is the measured value used to determine quality in testing.

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Corrective Action

Steps taken to address sources of error after identifying issues in testing.

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Signages

Visual aids used to communicate hazards and safety information in laboratories.

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Administrative Controls

Policies and guidelines designed to change how work is performed to enhance safety.

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Personal Protective Equipment (PPE)

Gear worn by workers to minimize exposure to hazards such as chemicals.

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Eye Protection

Equipment intended to protect eyes from hazardous splashes and particles.

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Universal Precautions

Guidelines introduced to prevent the transmission of infections in the workplace.

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R4S Rule Violation

Occurs when the range of highest and lowest control results exceeds 4 standard deviations (4SD).

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Random Error

An error that can cause variations in test results, often identified by R4S violations.

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41S Rule Violation

Occurs when four consecutive control results exceed ±1 standard deviation (±1SD).

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Systematic Error

Consistent, repeatable error in measurements, highlighted by 41S violations.

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10X Rule Violation

Occurs when 10 consecutive control results fall within a specific range indicating quality issues.

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Pre-Analytic Phase

The stage in laboratory testing that includes patient preparation, sample collection, and transport.

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Highest Error Rate

The pre-analytic phase has the highest rate of errors due to human handling issues.

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Incomplete Laboratory Request Forms

Forms with missing information leading to sample rejection, comprising 2/3 of issues.

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Wrong Patient Identification

Mistakes arising from misidentifying patients, affecting sample acceptance.

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Rejecting Results

A necessary step when violations occur in testing stages, indicating invalid data.

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Standardized Labelling

A consistent method for marking laboratory samples to ensure safe handling.

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Criteria for Rejecting Samples

Guidelines that determine if a sample is unsuitable for testing.

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Unlabeled Sample

A sample without any identification, leading to potential errors.

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Hemolyzed Sample

A sample where red blood cells have broken down, affecting test results.

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Ergonomic Hazard

Conditions that strain the body due to poor work posture or setup.

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Repetitive Motion Injuries

Injuries that develop from the same motion done repeatedly over time.

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Poor Illumination

Insufficient light that can lead to accidents or errors in the lab.

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Insufficient Patient Information

Lack of necessary details about a patient, hindering accurate testing.

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Transporting Specimen Standards

Protocols that ensure safe handling and transport of specimens.

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Non-fasting Samples

Samples taken from patients who did not fast when required, affecting results.

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Quality Control

Activities designed to ensure the quality of products or results, especially in laboratories.

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Definition of Quality Control

An aggregate of activities aimed at ensuring adequate quality, including inspection and analysis for defects.

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Types of Quality Control

Different methods or processes used to maintain quality standards in products or results.

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Quality Control in the Laboratory

Specific quality control practices to ensure reliable test results in a lab setting.

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Levey-Jennings Chart

A graphical tool used to display quality control data over time for analysis.

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ISO 9000

A standard outlining the operational techniques and activities necessary for quality management.

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Study Notes

Quality Management and Laboratory Safety

  • Quality control is a critical aspect of laboratory practices
  • Ensures accurate, reliable, and timely results
  • Essential for accurate diagnosis and effective treatment

Quality Control Definition

  • Quality control is the set of procedures and techniques used to maintain a desired level of quality.
  • Aims at quantifying the unavoidable errors to decide if they are acceptable.

Internal and External QC

  • Internal Quality Control (INTRALAB): In-house procedures, continuous monitoring of operations, and daily checks to ensure reliable data.
  • External Quality Control (INTERLAB): Collaborates with other labs, proficiency testing, and national and international programs.

Quality Control in the Laboratory

  • A system ensures accuracy and precision
  • Testing known samples to identify issues
  • Monitoring analytical processes to detect errors

Quality Control Charts (Levey-Jennings)

  • Common quality control tool
  • Graphically represent control data
  • Plots control values over time for analysis
  • Used for identifying trends and shifts in data
  • Calculate mean and standard deviation
  • Mark +1, +2, +3 standard deviation intervals
  • Identify whether a run is "in control" or "out of control"
  • Use Westgard Multirule to determine if results are acceptable
  • Identifying trends and shifts in data

Laboratory Workflow Phases

  • Pre-Analytic Phase: Patient preparation, sample collection, sample receipt, and sample transport, high error frequency.
  • Analytic Phase: Actual testing of samples, QC checks and analysis.
  • Post-Analytic Phase: Reporting and record keeping, reliability and proper data entry are crucial.

Laboratory Hazards

  • Chemical Hazards: Ingestion, needle-sticks, exposure, adverse health effects
  • Biological Hazards: Biohazards, exposure routes, health risks
  • Physical Hazards: Elements causing harm (e.g., temperature, radiation, slips).
  • Ergonomic Hazards: Work conditions stressing the body, repetitive motion.

Hierarchy of Controls

  • Elimination: Removing the hazard (e.g. physically removing the hazard).
  • Substitution: Replacing the hazard with something safer
  • Engineering Controls: Isolating the person from the hazard (e.g. fume hoods).
  • Administrative Controls: Changing work practices (e.g., SOPs, changing work schedule).
  • Personal Protective Equipment (PPE): Worker protection (e.g., lab coats, gloves).

Errors in Laboratory Work

  • Pre-Analytic Errors: Usually occur from human handling (i.e. wrong patient information, insufficient samples).
  • Analytical Errors: Equipment malfunction, incorrect procedures, QC failure.
  • Post-Analytic Errors: Reporting errors, improper data entry, or delays in reporting.

Key Performance Metrics

  • Turnaround time (TAT): The time taken to complete test/ order.
  • Accuracy: Closeness of a measurement to its true value.
  • Precision: Closeness of agreement among a set of test results.

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