Laboratory Management and Quality Control

This set of flashcards covers key terms and concepts related to laboratory management and quality control. Each card provides a definition to help students understand and memorize important vocabulary essential for their upcoming exam.

A process focused on fulfilling quality requirements by monitoring activities related to the examination phase of testing.

Quality Control (QC)

System that establishes, documents, implements, and maintains quality procedures and policies to improve effectiveness.

Quality Management System (QMS)

Tests that measure the presence or absence of a substance, resulting in terms like 'positive' or 'negative'.

Qualitative Examinations

Tests that measure the numerical quantity of an analyte present in a sample.

Quantitative Examinations

Tests that estimate the amount of a substance, often expressed in terms like 'trace amounts' or '1+'.

Semi-Quantitative Examinations

International standard that specifies requirements for quality and competence in medical laboratories.

ISO 15189

Substances containing known amounts of analytes used to validate the reliability of testing systems.

Control Materials

The ability of a test to correctly identify those with the disease (true positive rate).

Sensitivity

The ability of a test to correctly identify those without the disease (true negative rate).

Specificity

Chance of having a disease if the test result is abnormal.

Positive Predictive Value

Chance of not having a disease if the test result is within the reference interval.

Negative Predictive Value

Ability of a test to detect small quantities of an analyte.

Analytic Sensitivity

Ability of a test to detect only the analyte of interest.

Analytic Specificity

Monitoring conducted within the laboratory using control samples analyzed alongside patient specimens.

Intralab Quality Control (Internal QC)

Proficiency testing involving the evaluation of test results from multiple laboratories.

Interlab Quality Control (External QC)

Graphs used to visualize control values to determine if they are 'in-control' or 'out of control'.

Levey-Jennings Charts

The average value calculated by summing observations and dividing by the number of observations.

Mean

The middle value in a dataset after the data have been ordered.

Median

The most frequently occurring value in a dataset.

Mode

A measure that indicates the dispersion of data points from the mean.

Standard Deviation

The difference between the largest and smallest values in a dataset.

Range

A standardized measure of dispersion calculated as the ratio of the standard deviation to the mean.

Coefficient of Variation (CV)

Includes statements of quality policy, a quality manual, and procedures and records.

Documentation Requirements for QMS

A document that includes quality policy, scope of QMS, and management structure.

Quality Manual

Measures taken to rectify discrepancies identified during quality control processes.

Corrective Actions

Goals set within a quality management system to improve overall performance.

Quality Objectives

Ensuring all laboratory staff are properly trained in quality control procedures.

Training Requirements

Recognition provided to laboratories that meet certain standards for quality and competency.

Accreditation

The process of obtaining measurements that closely match the true value.

Accurate Measurement

The process of obtaining consistent and repeatable results.

Precise Measurement

A distribution with two different modes (peaks).

Bimodal Distribution

The extent to which data points in a set differ from each other.

Data Variability

A summary of how often different values occur within a dataset.

Frequency Distribution

A probability distribution that is symmetric about the mean, forming a bell-shaped curve.

Normal Distribution

The range of acceptable values established for control materials in testing.

Control Range

Criteria that must be met for a laboratory to be officially recognized as competent.

Accreditation Standards

A method of assessing the performance of a laboratory by comparing its results to those of others.

Proficiency Testing

Factors in the lab environment that can affect test results.

Environmental Conditions

The organizational framework defining roles and responsibilities within the laboratory.

Laboratory Management Structure

The process of setting or correcting a measuring device or instrument.

Calibration

Detailed, written instructions to achieve uniformity in the performance of a specific function.

SOPs (Standard Operating Procedures)

Written records that provide evidence of compliance with quality management requirements.

Documentation

Laboratories that have been officially recognized as competent by an accrediting body.

Accredited Laboratories

Processes to ensure that laboratory instruments are functioning correctly.

Equipment Verification

Ongoing efforts to enhance processes and outcomes within a quality management system.

Quality Improvement

Critical values or thresholds used in clinical decision making.

Medical Decision Points

Graphs used to monitor the performance of a process over time.

Control Charts

In-house control materials whose target values must be established by the laboratory.

Unassayed Controls

Control materials with predetermined target values established by manufacturers.

Assayed Controls

The process of adding a solvent to a lyophilized substance to restore it to its original state.

Reconstitution

Very small quantities of a substance detected in a test.

Trace Amounts

Quantities that are noticeable but not particularly high.

Moderate Amounts

Calibrators set instrument parameters, while controls validate the testing process.

Calibrators vs Controls

The ongoing assessment of control material results to ensure compliance with standards.

Control Value Monitoring

The maximum or minimum values set for a process that are acceptable in quality control.

Critical Control Limits

The consistency of results over an extended period in external quality control.

Long Term Accuracy

Testing uncharacterized samples under the same conditions as patient samples.

Analysis of Unknown Samples

Records that detail the findings from quality control testing activities.

Documentation of QC Results

How often quality control tests are conducted to ensure consistent performance.

Frequency of Testing

The process of gathering information for analysis and interpretation.

Data Collection

Specific methods and protocols followed during laboratory analyses.

Testing Procedures

Factors that can influence test outcomes prior to the analytical phase of testing.

Pre-analytical Variables

The stage of testing focused on the actual measurement and analysis of samples.

Analytic Phase

Structured programs established to ensure ongoing quality in laboratory processes.

Quality Assurance Programs

Measures taken to protect patients from preventable harm during laboratory testing.

Patient Safety

Actions taken to ensure accuracy, precision, and reliability in laboratory testing.

Quality Control Measures

The sequence in which tests are performed in a laboratory setting.

Testing Order

The ability of a laboratory to produce reliable and accurate test results.

Laboratory Competency

An established structure for achieving and maintaining quality in laboratory processes.

Quality Framework

Methods used to examine and assess compliance with quality standards.

Audit Procedures

The preservation and protection of samples through the testing process.

Sample Integrity

Metrics used to assess the performance and quality of laboratory services.

Quality Indicators

Adherence to laws, regulations, and standards governing laboratory practices.

Regulatory Compliance

Educational programs designed to equip staff with necessary skills and knowledge.

Personnel Training