Podcast
Questions and Answers
In the context of Total Quality Management (TQM), what is the most critical role of senior management in guaranteeing quality improvement?
In the context of Total Quality Management (TQM), what is the most critical role of senior management in guaranteeing quality improvement?
- Supporting frontline employees and empowering them to make process improvements. (correct)
- Overseeing budget allocation for frontline operations to ensure cost containment.
- Designing and implementing standardized protocols for all laboratory procedures.
- Directly managing daily operations to maintain consistent adherence to quality standards.
A clinical laboratory aims to ensure that its processes consistently produce reliable and accurate test results. Which strategy would be most effective in achieving this objective?
A clinical laboratory aims to ensure that its processes consistently produce reliable and accurate test results. Which strategy would be most effective in achieving this objective?
- Reducing the frequency of equipment maintenance to minimize downtime and operational costs.
- Limiting the types of tests offered to reduce complexity and potential errors.
- Increasing the number of tests performed to enhance staff proficiency.
- Implementing consistent monitoring and evaluation of laboratory performance along with corrective actions. (correct)
What is the primary rationale behind incorporating quality control measures into each assay run in a clinical laboratory?
What is the primary rationale behind incorporating quality control measures into each assay run in a clinical laboratory?
- To enhance the competency of laboratory personnel through regular performance evaluations.
- To ensure the laboratory meets predetermined quality benchmarks. (correct)
- To minimize operational costs by identifying the most efficient testing methods.
- To comply with regulatory requirements and avoid potential legal liabilities.
In the context of quality assurance (QA), what differentiates it most significantly from quality control (QC)?
In the context of quality assurance (QA), what differentiates it most significantly from quality control (QC)?
What is the most critical implication of a clinical laboratory failing to meet established quality standards?
What is the most critical implication of a clinical laboratory failing to meet established quality standards?
A laboratory is implementing a new QC program. What initial steps should it take to ensure its effectiveness?
A laboratory is implementing a new QC program. What initial steps should it take to ensure its effectiveness?
Which of the errors listed below is considered a preanalytical variable in quality management?
Which of the errors listed below is considered a preanalytical variable in quality management?
A clinical laboratory aims to enhance the reliability and accuracy of its analytical measurements. Which strategy would be most effective?
A clinical laboratory aims to enhance the reliability and accuracy of its analytical measurements. Which strategy would be most effective?
What is the primary significance of 'calibration' in the context of analytical methods within a clinical laboratory?
What is the primary significance of 'calibration' in the context of analytical methods within a clinical laboratory?
How does establishing 'trueness' contribute to the validity of measurements in a clinical laboratory?
How does establishing 'trueness' contribute to the validity of measurements in a clinical laboratory?
Why is 'linearity' a crucial factor when assessing the quality of an analytical test?
Why is 'linearity' a crucial factor when assessing the quality of an analytical test?
What is the primary purpose of determining the 'Limit of Quantification' (LoQ) in a clinical assay?
What is the primary purpose of determining the 'Limit of Quantification' (LoQ) in a clinical assay?
What operational adjustments might a laboratory technician undertake to address identified analytical imprecision NOT caused by equipment?
What operational adjustments might a laboratory technician undertake to address identified analytical imprecision NOT caused by equipment?
What is the MOST important reason a clinical laboratory needs to keep instruction manuals available for use?
What is the MOST important reason a clinical laboratory needs to keep instruction manuals available for use?
After putting a new piece of equipment in service, what validation exercise would be MOST helpful?
After putting a new piece of equipment in service, what validation exercise would be MOST helpful?
What action should a lab manager take to ensure the accuracy of analytical results when a pipette fails an accuracy check?
What action should a lab manager take to ensure the accuracy of analytical results when a pipette fails an accuracy check?
Why must reagents used in clinical laboratories be carefully managed and stored according to the manufacturer's recommendations?
Why must reagents used in clinical laboratories be carefully managed and stored according to the manufacturer's recommendations?
When bringing a new lot of reagent into service, what parallel testing should a medical laboratory scientist MOST likely perform?
When bringing a new lot of reagent into service, what parallel testing should a medical laboratory scientist MOST likely perform?
What is the MOST important factor in restricting clinical testing procedures to personnel with appropriate technical training?
What is the MOST important factor in restricting clinical testing procedures to personnel with appropriate technical training?
Given the framework of laboratory quality control, what action is considered most crucial regarding documentation?
Given the framework of laboratory quality control, what action is considered most crucial regarding documentation?
How do 'Standard Operating Procedures' (SOPs) primarily contribute to ensuring reliability and consistency in laboratory operations?
How do 'Standard Operating Procedures' (SOPs) primarily contribute to ensuring reliability and consistency in laboratory operations?
In a clinical laboratory, what is the primary purpose of test validation?
In a clinical laboratory, what is the primary purpose of test validation?
Why is it essential to monitor fridge, freezer, and incubator temperatures as part of laboratory housekeeping?
Why is it essential to monitor fridge, freezer, and incubator temperatures as part of laboratory housekeeping?
What is the role of the standard deviation index (SDI) in quality control within a clinical laboratory?
What is the role of the standard deviation index (SDI) in quality control within a clinical laboratory?
A clinical laboratory technologist notes that quality-control values have exceeded reference limits. Following protocol, what action should be taken FIRST?
A clinical laboratory technologist notes that quality-control values have exceeded reference limits. Following protocol, what action should be taken FIRST?
When using control materials, what characteristic is MOST important?
When using control materials, what characteristic is MOST important?
What is the primary difference between a calibrator and a control in a clinical laboratory setting?
What is the primary difference between a calibrator and a control in a clinical laboratory setting?
What is the primary advantage of laboratories regularly using Levy-Jennings charts?
What is the primary advantage of laboratories regularly using Levy-Jennings charts?
In a clinical laboratory, if a control data point on a Levy-Jennings Chart falls outside ±2SD, what initial action is MOST appropriate according to Westgard rules?
In a clinical laboratory, if a control data point on a Levy-Jennings Chart falls outside ±2SD, what initial action is MOST appropriate according to Westgard rules?
As per the Westgard Rules, which of the following best describes the '13s' rule regarding quality control data?
As per the Westgard Rules, which of the following best describes the '13s' rule regarding quality control data?
According to the Westgard rules, what action should a clinical laboratory take if two consecutive control values for the same level are outside ±2SD in the same direction?
According to the Westgard rules, what action should a clinical laboratory take if two consecutive control values for the same level are outside ±2SD in the same direction?
Which statement BEST describes the appropriate laboratory response when the R4s Westgard rule is violated?
Which statement BEST describes the appropriate laboratory response when the R4s Westgard rule is violated?
What is the significance of the '10x rule' in Westgard's rules for quality control, and what type of error does it primarily indicate?
What is the significance of the '10x rule' in Westgard's rules for quality control, and what type of error does it primarily indicate?
After a QC failure, what immediate step should a laboratory technician undertake before escalating concerns?
After a QC failure, what immediate step should a laboratory technician undertake before escalating concerns?
What is the purpose of a delta check?
What is the purpose of a delta check?
How do External Quality Assessment (EQA) programs primarily contribute to improving the performance of clinical laboratories?
How do External Quality Assessment (EQA) programs primarily contribute to improving the performance of clinical laboratories?
EQA results are back and a lab has been alerted by the agency. Along with corrective action, what should a lab manager do?
EQA results are back and a lab has been alerted by the agency. Along with corrective action, what should a lab manager do?
What should labs with more than one method or system for testing analytes do for QC?
What should labs with more than one method or system for testing analytes do for QC?
Which scenario exemplifies a successful implementation of Total Quality Management (TQM) principles in a clinical laboratory?
Which scenario exemplifies a successful implementation of Total Quality Management (TQM) principles in a clinical laboratory?
Which initiative best demonstrates a clinical laboratory's commitment to quality assurance across all testing phases?
Which initiative best demonstrates a clinical laboratory's commitment to quality assurance across all testing phases?
In Traditional Chromatography, what action ensures the most accuracy?
In Traditional Chromatography, what action ensures the most accuracy?
A laboratory evaluates a new assay and finds that the measured concentrations deviate significantly from the true concentrations, even though the test demonstrates high repeatability. This assay suffers from:
A laboratory evaluates a new assay and finds that the measured concentrations deviate significantly from the true concentrations, even though the test demonstrates high repeatability. This assay suffers from:
What does a laboratory do to best assure precision when starting to use a new lot of reagents?
What does a laboratory do to best assure precision when starting to use a new lot of reagents?
What action should be taken in the event of problems found from internal audits?
What action should be taken in the event of problems found from internal audits?
A clinical laboratory implements a new Total Quality Management (TQM) system. Which outcome would indicate the MOST successful integration of TQM principles?
A clinical laboratory implements a new Total Quality Management (TQM) system. Which outcome would indicate the MOST successful integration of TQM principles?
In a clinical laboratory setting, which approach represents the MOST effective application of Total Quality Management (TQM) principles for enhancing overall quality?
In a clinical laboratory setting, which approach represents the MOST effective application of Total Quality Management (TQM) principles for enhancing overall quality?
A laboratory aims to improve its processes using the Continuous Quality Improvement (CQI) model. Which of the following actions would MOST effectively align with the principles of CQI?
A laboratory aims to improve its processes using the Continuous Quality Improvement (CQI) model. Which of the following actions would MOST effectively align with the principles of CQI?
How does Quality Assurance (QA) MOST effectively ensure positive patient outcomes in a clinical laboratory?
How does Quality Assurance (QA) MOST effectively ensure positive patient outcomes in a clinical laboratory?
How has the focus of quality control in clinical laboratories evolved since the initial recommendations of 1965?
How has the focus of quality control in clinical laboratories evolved since the initial recommendations of 1965?
In a clinical laboratory, which of the following BEST describes the 'Quality System'?
In a clinical laboratory, which of the following BEST describes the 'Quality System'?
A clinical laboratory is implementing a new quality system. What initial steps should be taken to ensure its effectiveness?
A clinical laboratory is implementing a new quality system. What initial steps should be taken to ensure its effectiveness?
What is the key objective of a clinical laboratory's implementation and follow-up on corrective actions for non-conformance to procedures?
What is the key objective of a clinical laboratory's implementation and follow-up on corrective actions for non-conformance to procedures?
Which approach would BEST support a clinical laboratory in establishing robust testing systems for success?
Which approach would BEST support a clinical laboratory in establishing robust testing systems for success?
Why is it MOST important for a clinical laboratory to ensure its operations are organized and standardized?
Why is it MOST important for a clinical laboratory to ensure its operations are organized and standardized?
In the context of ensuring quality in a clinical laboratory, how do 'Quality Control' and 'Quality Assessment' interact to contribute to 'Quality Assurance'?
In the context of ensuring quality in a clinical laboratory, how do 'Quality Control' and 'Quality Assessment' interact to contribute to 'Quality Assurance'?
A clinical laboratory is developing a comprehensive Quality Assurance program. What elements should be included to ensure the program effectively monitors and improves lab performance?
A clinical laboratory is developing a comprehensive Quality Assurance program. What elements should be included to ensure the program effectively monitors and improves lab performance?
What is the MOST significant role of internal quality assessment in maintaining standards?
What is the MOST significant role of internal quality assessment in maintaining standards?
In evaluating the assessment of quality systems in a clinical laboratory, how does a 'man-driven' approach differ from a 'material-driven' approach?
In evaluating the assessment of quality systems in a clinical laboratory, how does a 'man-driven' approach differ from a 'material-driven' approach?
What is the MOST critical distinction in the aims of Quality Control (QC) versus Quality Assurance (QA) in a clinical laboratory?
What is the MOST critical distinction in the aims of Quality Control (QC) versus Quality Assurance (QA) in a clinical laboratory?
A clinical laboratory is developing a Quality Assurance (QA) program. Which components are essential to include to ensure effective QA across all testing phases?
A clinical laboratory is developing a Quality Assurance (QA) program. Which components are essential to include to ensure effective QA across all testing phases?
Quality control is vital to quality assurance because it provides:
Quality control is vital to quality assurance because it provides:
How can documentation in quality control contribute to improved patient outcomes in a clinical laboratory?
How can documentation in quality control contribute to improved patient outcomes in a clinical laboratory?
Beyond laboratory specialists and clinicians, which factor is MOST critical for ensuring quality in clinical laboratories?
Beyond laboratory specialists and clinicians, which factor is MOST critical for ensuring quality in clinical laboratories?
Which outcome is the MOST direct consequence of inadequate quality in a clinical laboratory?
Which outcome is the MOST direct consequence of inadequate quality in a clinical laboratory?
In which of the following scenarios would a handwritten test order pose the GREATEST risk to quality control?
In which of the following scenarios would a handwritten test order pose the GREATEST risk to quality control?
What is the MOST effective approach to minimize errors related to patient identification in the preanalytical phase?
What is the MOST effective approach to minimize errors related to patient identification in the preanalytical phase?
A clinical laboratory aims to improve its handling of preanalytical variables. Which action would have the MOST significant impact?
A clinical laboratory aims to improve its handling of preanalytical variables. Which action would have the MOST significant impact?
What principle should be applied to reduce variability from personnel that can cause preanalytical issues?
What principle should be applied to reduce variability from personnel that can cause preanalytical issues?
A clinical laboratory seeks to enhance the reliability and accuracy of its analytical measurements. What step is generally MOST effective?
A clinical laboratory seeks to enhance the reliability and accuracy of its analytical measurements. What step is generally MOST effective?
Why is monitoring temperature crucial in refrigerators and freezers in a clinical laboratory?
Why is monitoring temperature crucial in refrigerators and freezers in a clinical laboratory?
Why is pipette calibration so important to quality control?
Why is pipette calibration so important to quality control?
What is the PRIMARY reason for clinical laboratories to meticulously manage and store reagents in accordance with manufacturer guidelines?
What is the PRIMARY reason for clinical laboratories to meticulously manage and store reagents in accordance with manufacturer guidelines?
When should a lab date and initial reagents?
When should a lab date and initial reagents?
A laboratory is introducing a new lot of reagent into service. What PRIMARY step should a medical laboratory scientist perform to ensure ongoing accuracy?
A laboratory is introducing a new lot of reagent into service. What PRIMARY step should a medical laboratory scientist perform to ensure ongoing accuracy?
To ensure ongoing quality, who is MOST important in restricting testing procedures to personnel for clinical testing?
To ensure ongoing quality, who is MOST important in restricting testing procedures to personnel for clinical testing?
It is important for a clinical setting to have appropriate documentation, because:
It is important for a clinical setting to have appropriate documentation, because:
Why are Standard Operating Procedures (SOPs) essential for the operations in a clinical laboratory?
Why are Standard Operating Procedures (SOPs) essential for the operations in a clinical laboratory?
An important part of test validation is:
An important part of test validation is:
After a standard operating procedure, what requires validation?
After a standard operating procedure, what requires validation?
During reporting results, what must be included?
During reporting results, what must be included?
A lab has too many steps, and wants to simplify it, to prevent errors. Where would you begin?
A lab has too many steps, and wants to simplify it, to prevent errors. Where would you begin?
In statistical control, what does a Coefficient of Variation (CV) greater than 2.0 usually indicate?
In statistical control, what does a Coefficient of Variation (CV) greater than 2.0 usually indicate?
In a comparison with the peer group, which target of Standard Deviation Index, SDI, indicates the best comparison?
In a comparison with the peer group, which target of Standard Deviation Index, SDI, indicates the best comparison?
What is the MOST appropriate first step to take when quality controls exceed established reference ranges?
What is the MOST appropriate first step to take when quality controls exceed established reference ranges?
A clinical laboratory implements a new policy requiring frontline employees to participate in process improvement teams. Which management action would MOST reinforce this implementation?
A clinical laboratory implements a new policy requiring frontline employees to participate in process improvement teams. Which management action would MOST reinforce this implementation?
A clinical laboratory aims to minimize transcription errors associated with manual data entry. Which strategy would be MOST effective?
A clinical laboratory aims to minimize transcription errors associated with manual data entry. Which strategy would be MOST effective?
A laboratory is experiencing increased turnaround times (TAT) for a specific test. What intervention should be implemented?
A laboratory is experiencing increased turnaround times (TAT) for a specific test. What intervention should be implemented?
When introducing a new lot of reagent, which assessment is MOST critical to perform to ensure accuracy?
When introducing a new lot of reagent, which assessment is MOST critical to perform to ensure accuracy?
What is the MOST important factor in maintaining a high level of quality when restricting clinical testing procedures?
What is the MOST important factor in maintaining a high level of quality when restricting clinical testing procedures?
Which of the following will BEST ensure effective competency?
Which of the following will BEST ensure effective competency?
What is the MOST appropriate action to take when QC results are not within acceptable limits?
What is the MOST appropriate action to take when QC results are not within acceptable limits?
According to guidelines, which of the following values indicate a need for immediate investigation and corrective action?
According to guidelines, which of the following values indicate a need for immediate investigation and corrective action?
Which of the following control materials ensures the HIGHEST quality control?
Which of the following control materials ensures the HIGHEST quality control?
What is the purpose of running both internal and external controls?
What is the purpose of running both internal and external controls?
A laboratory that implements electronic interfaces with a laboratory information system can expect what?
A laboratory that implements electronic interfaces with a laboratory information system can expect what?
What is the appropriate throughput time for specimens?
What is the appropriate throughput time for specimens?
A new instrument that will perform a test that has previously been outsourced should be:
A new instrument that will perform a test that has previously been outsourced should be:
What is the MOST important reason to document service to equipment?
What is the MOST important reason to document service to equipment?
A tech notices that the pipette is not accurately and precisely distributing material. The tech should:
A tech notices that the pipette is not accurately and precisely distributing material. The tech should:
When should reagents be labeled?
When should reagents be labeled?
When using a new reagent, what percentage of variability is acceptable?
When using a new reagent, what percentage of variability is acceptable?
Which document is likely MOST important?
Which document is likely MOST important?
What document is helpful in ensuring uniformity in laboratory procedures?
What document is helpful in ensuring uniformity in laboratory procedures?
Which is the BEST definition of the document Author and Approved Signature in CLSI?
Which is the BEST definition of the document Author and Approved Signature in CLSI?
Flashcards
What is Quality?
What is Quality?
The sum-total of all characteristics of a product/service that bears on the utilization with entire satisfaction of the consumer.
Total Quality Management (TQM)
Total Quality Management (TQM)
An activity to improve patient care by monitoring the lab's work for deficiencies and correcting them.
Quality Assurance (QA)
Quality Assurance (QA)
Activities ensuring positive patient outcomes, measuring a lab's reliability.
Fundamentals of Quality Management
Fundamentals of Quality Management
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Total Quality Management
Total Quality Management
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Total Quality Management (TQM)
Total Quality Management (TQM)
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Universal principles of TQM
Universal principles of TQM
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Quality Systems Objective
Quality Systems Objective
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Quality Control (QC)
Quality Control (QC)
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Quality Assurance (QA)
Quality Assurance (QA)
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Purpose of QA
Purpose of QA
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Quality Laboratory Process
Quality Laboratory Process
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Quality Control
Quality Control
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Quality Assessment
Quality Assessment
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Quality Improvement
Quality Improvement
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Quality Planning
Quality Planning
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Quality Control
Quality Control
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Documentation
Documentation
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Quality in labs
Quality in labs
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Main Objective Of Laboratory
Main Objective Of Laboratory
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Objectives of quality
Objectives of quality
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Poor quality consequences
Poor quality consequences
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Implement a QC program
Implement a QC program
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Preanalytical variables
Preanalytical variables
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Variables Controlled
Variables Controlled
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Analytical Variables
Analytical Variables
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Calibration function
Calibration function
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Trueness of measurements
Trueness of measurements
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Accuracy
Accuracy
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Precision
Precision
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Reliability
Reliability
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Linearity
Linearity
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Limit of blank (LoB)
Limit of blank (LoB)
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Limit of Detection (LoD)
Limit of Detection (LoD)
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Limit of Quantification (LoQ)
Limit of Quantification (LoQ)
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Reagents storage requirements
Reagents storage requirements
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Personnel requirements
Personnel requirements
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Value of Documentation
Value of Documentation
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Documentation:
Documentation:
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Standard Operating Procedures (SOP)
Standard Operating Procedures (SOP)
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Validation
Validation
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Validation
Validation
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Levy-Jennings graph
Levy-Jennings graph
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Westgard 13s Rule
Westgard 13s Rule
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Westgard Rules
Westgard Rules
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Control materials
Control materials
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Calibrators
Calibrators
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Control charts
Control charts
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Westgard Rules
Westgard Rules
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Internal Qualtity Control
Internal Qualtity Control
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Study Notes
- Quality is the sum-total of all the characteristics that bear upon the utilization of a product or service to the entire satisfaction of the consumer
Quality Attributes
- Acceptance
- Accessibility
- Affordability
- Appropriateness
The Importance of Quality
- Quality is invisible when good
- Quality is impossible to ignore when bad
Introduction to Quality Control
- Laboratory quality has evolved over 4 decades
- The first recommendation for lab quality control was published in 1965
- Quality control is now seen as one part of the total laboratory control program
- This larger program can be described as Total Quality Management, which aims to improve patient care
- QA ensures positive patient outcomes and assesses lab reliability
Fundamentals of Quality Management
- Principles of quality management, assurance, and control, are the foundation for managing and operating clinical laboratories
- They include total quality management, managing pre-analytical and analytical variables, and external quality assessment, and proficiency testing programs
Total Quality Management (TQM)
- TQM is a management philosophy for organizational development and a management process for quality improvement across all work aspects
- It is also referred to as quality control (QC), total quality leadership, continuous quality improvement, quality management, or industrial quality management
- Public and private pressures to contain costs now accompany pressures for quality improvement (QI)
Concepts of TQM
- The Universal principles of TQM involve customer focus, management buy-in, training, process capability, and control of and measurement using quality-improvement tools
- Costs must be understood in the context of quality
- Quality = conformance to requirements
- "Quality costs" equal the "costs of conformance" plus the "costs of non-conformance"
Costs of Conformance
- This includes prevention costs in the form of training, calibration, and maintenance
- This includes appraisal costs in the form of inspection and quality control
Costs of Nonconformance
- This includes internal failure costs such as scrap, rework, and repeat runs
- This includes external failure costs in the form of patient complaints, and service requests
Understanding Quality and Costs
- Understanding quality & cost leads to a new understanding of relationship b/n these two concepts
- "Improvement in quality lead to reduction in costs"
- Quality improvement occurs when problems are eliminated permanently
- Quality problems are primarily management problems
- Management has the power to change work processes
- Most processes for service delivery entail the frontline employees
- Senior management's role is to support and empower frontline employees.
Implementing TQM
- Quality laboratory process includes analytical processes and the policies, practices, and procedures that define how all aspects of the work are done
- Quality control emphasizes statistical control procedures and nonstatistical check procedures
- Quality assessment is concerned with measures and monitors of lab performance, including turnaround time, and identification for specimen and patient
- The core of quality improvement is a problem-solving process that structures solutions to address root problems in quality
- Quality planning provides the planning steps
The 5 Q's
- The "Five -Q" Total quality management framework describes how quality is managed objectively using the "scientific method" or PDCA cycle
- QP provides the planning step
- QLP establishes standard processes
- QC & QA provide measures for checks
- QI provides a mechanism through which to act on those measures
- TQM is also considered as a quality system (QS) that implements to ensure quality
Quality Systems (QS)
- QS is the set of key quality elements that must be present for an organization's work operations to meet the organization's stated quality objectives
- Its essentials include documents, records, organization, personnel, equipment, purchasing, inventory, etc
- The main objective of a laboratory is to provide reliable, timely and accurate test results
- This is only possible through consistent monitoring and evaluation of the laboratory's performance and corrective actions for non-conformance
Maintaining Quality
- A reputation built on 10,000 good results is damaged by a single poor result
- Establishment of robust testing systems is essential to laboratory success
- Continuous monitoring of quality systems in each testing laboratory is required for reliable and robust testing
The Value of Quality Systems
- It provides assurance of test result quality
- It helps ensure lab operations are coordinated, organized and standardized
- It helps monitor performance
Quality Assurance Defined
- QUALITY ASSURANCE = QC + QUALITY ASSESSMENT
- or
- QUALITY ASSURANCE = Internal QC + External QA
Quality Assurance: Internal and External
- Internal Quality Control (IQC) includes personnel, instrumentation, document control, reagent control, and corrective action
- External Quality Assurance (EQA) and control is important to guarantee performance to an external standard
Assessment of Quality System
- Quality assessment can be man-driven with audits, on-site inspections, and accreditation or material driven by internal and external systems
- External Quality Assessment Scheme (EQAS) provides a schematic way to evaluate a lab
QC compared to QA
- Quality Control (QC) refers to operational techniques that must be included during each assay run to meet requirements
- Quality Assurance (QA) refers to all those planned and systematic activities that provide confidence in results
- QC serves to ensure tests are correct, but QA is more concerned with right practices, interpretation, and communication of lab results
Quality Assurance Components
- The purpose of QA is to ensure the overall quality of patient results, accounting for all factors that effect the test results form the time of the test
Pre-analytic QA
- This involves specimen collection, specimen transport, and specimen quality
Analytic QA
- This involves accuracy with results, clerical errors, analytical errors, and assay repeat rates
Post-analytic QA
- This involves reporting results, and record keeping for patients and QC
3 Phases of Quality
- The quality assurance cycle illustrates that patient prep and sample collection occur during pre-analysis stage
- Data & Lab Management, safety, and customer service occur during reporting
- Quality control testing and competency testing occur during the analytic processing
Quality Control in Context
- QC is a vital part of quality assurance, and it is a mutual responsibility laboratory specialists and clinicians
- All labs benefit from quality control in terms of confidence in and reproducibility of test results
- Recording/monitoring test variables allows one to look objectively at parameters vital to the test
- Documentation allows one to foresee a problem before the situation requires action
What are the Objectives of Lab Quality
- High quality health-care
- Reduce morbidity (illness)
- Reduce mortality (death)
- Reduce economic loss
- Ensures credibility of the lab
- Generate confidence in lab results
Potential Consequences of Poor Quality
- Inappropriate action
- Delay action
- Loss of credibility
- Legal action
How to implement a QC program?
- Written policies & procedures
- Assign monitoring and review responsibility
- Train staff
- Obtain control materials
- Collect data
- Set target values, create control charts, and routinely plot control data
- Establish, implement, and maintain documentation
- Establish and troubleshoot problems
Hurdles in Quality Control
Process
- Test ordering
- Specimen acquisition
- Analytical measurement
- Test reporting
- Test interpretation
Potential Errors
- Inappropriate test
- Handwriting not legible
- Transcribing errors
- Specificity not understood
Pre-analytical Variables
- Preanalytical variability is defined as errors that occur when non-analytical factors change the conc. of analytes
- Managing it involves:
- Appropriate test request and performance
- Proper patient identification, and proper data logs
- Keeping turnaround times (TAT) minimal
More Pre-analytical Variables
- It includes proper patient preparation
- Collection of sample using correct method
- Monitoring temperatures in transport for special test
- Proper separation, such monitoring the centrifuge
Factors Influencing Analytical Variables
- Proficiency of personnel
- Reagents Stability Integrity and Efficiency
- Using Appropriate Controls
- Equipment Reliability
- Specificity & Sensitivity of Selected Test
- Adequate ST, Sufficient SP, Cost effective, compatible with, meets needs / objectives, validated
- Documentation
Managing Analytical Variables
- Analytical variables must be controlled carefully to ensure accurate measurements
- Reliable analytical methods are obtained through appropriate selection, evaluation, implementation, and so on
- Clear concepts in relation to Analytical methods include calibration, trueness, accuracy, precision, and linearity
Calibration
- It is the relationship between instrument signal and analyte
- It is a set of operations that establish a relationship between instrument data and measurement standards
- Graphically it can be linear or curved
- HPLC has calibration that can be customized to specific processes
- y=f’(x)
- x=f ¹(y)
Trueness
- Trueness of measurements is the closeness of agreement between the average of a large series of results and a true value
- The true value is a known, accepted value of a quantifiable property
- Bias quantifies the difference between average and true value
- A measured value is a result of individual measurement of property
Accuracy
- Accuracy is the closeness of the agreement b/n the result of a measurement and a true conc. of the analyte
Precision
- Precision represents the closeness of agreement b/n independent results measure under stipulated tests
- It is measured for dispersion of replicated measurements
- Inter-assay occurs with multiple runs in different labs
- Intra-assay occurs within a run (different days)
Precision Described
- Repeatability: It is the closeness of results to each other when performed under same conditions
- Reproducibility: It is the closeness of measurement results performed under different conditions
- It is measured by the standard deviation (SD) or coefficient of variation (CV)
- Standard dev (σ)/mean(X) x 100 = % CV
Reliability
- Reliability demonstrates the ability to maintain both precision and accuracy
Linearity
- This refers to correlation between measured and expected values over the analytical measurement range, in relation to actual or relative analyte concentration
- It is evaluated by plotting measured and expected concentration
- Testing linearity reveals the trueness over its measurement range
- Linearity is prerequisite for a high degree of trueness
Limits of Quantification & Detection
- Limit of blank: represents the highest measurement result that is be observed for a blank sample
- Limit of Detection (LoD): denotes the lowest concentration of measurand that an be consistently detected in >95% samples under normal conditions
- Limit of Quantification (LoQ): represents the amount of analyte that can be reliably detected and meet for accuracy
Variables That May Cause Imprecision
- Equipment with multiple instruments, and pipette concerns
Reagents May Cause Imprecision
- A wide range of lots are often included in standard evaluations
Staff Must Be Accounted For
- Difference in training and competencies accounts for major variation
Laboratory Equipment
- All lab equipment should have operations and use manuals regarding the proper use of equipment
- Equipment must be monitored and recorded for quality assurance
- Temperature must be recorded and equipment tracked daily
More on Equipment
- Before putting equipment in service or introducing new method it must be validated
- Accomplish validation by the method of correlation or agreement studies
- Validate the new method against existing method to ensure accurate data
Instrument Maintenance
- Manufacturers can provide controls, calibrators, and maintenance schedules
- This includes daily, weekly and monthly instrumentation logs
More Information about QC: Routine Maintenance
- Instruments are to be regularly serviced by a technician
- This is required for producing reliable results and minimizing breakdown
- It also lowers cost and prevents delays in reporting
Pipette's Impact on QC
- Pipettes must be checked for accuracy and calibrated to maximize their validity
- All pipettes failing checks are to be serviced/cleaned by vendors
- Maintain data such as pipette calibration and check functionality serial numbers
Reagents In Laboratory
- Always store reagents according to manufacturers suggestions
- Upon receipt date and initial all reagents
- Transfer numbers and lots in books
- Ensure they are labeled correctly when put into service
Reagent Parallel Testing
- New and old reagent tests should be checked before use against controls
- Variability should only be within 5%
- All of this data should be recorded as well as any variability
How to Manage Personnel
- In all testing proper procedures should be performed with staff
- Assess their capabilities and document them
Key Requirements For Personnel
- Active participation by all staff is required to meet standards & continuously improve
- A laboratory director should employ sufficient staffing
- Continuing education training needs to occur
- Documentation, meetings, and discussions are needed for improvement
Documentation
- If you have not documented it, you have NOT done it
- If you have not documented, is a RUMOUR
The Value In Documentation
- It ensures the traceability of the process is secure and external assessments can take place
- Ensures effective training system
Key Documents
- Documentation of temperature of equipment of reagent use are requirements
- History and logs
Standard Operating Procedures (SOP)
- Its content must describe all aspects of the lab procedure in detail
- SOP facilitates uniformity across experiments and team members
- Standard operations should define test performance, limits, and requirements for quality control
The SOP Structure
- It must be written the CLSI-adhering format
- Laboratory director must sign the SOP
- All testing methods and tests must be available
- Reference guides and information should be included
- Dated removal procedures and obsolete notes must be available for 2 years
Requirements Under CLSI Formatting
- Title denoting statement, and clear intent
- Clinical implications and theories
- Procedures for how to do a certain process
- Documents
- References
- Attachments
- Authors
- Approved signatures
Validation
- Validation determines whether something operates at it's intended purpose
Importance of Validation
- Validation should be determined before the implementation of any changes
Key Points For Validation
- Must be achieved for SOP, reagents, and equipment
Factors Influencing post-analytic quality
- Accuracy is key, including right reporting, and turnaround
- Reports must meet end user
Reporting Results
- All data entry results should be verified by a section head or supervisor
- Any reports that were sent should also be sent to the database
- The old record should should remain on hand for evaluation
Housekeeping
- Surface decontamination of instruments is needed to to maintain proper equipment and testing
- Disposal of dangerous products and proper storage procedures should be adhered to
Statistical Control of Analytical Methods
- Statistics include mean, median, standard deviation which are important for statistical testing
- The coefficient of variation (CV) is the ratio of the SD to the average. It is a measure of precision expressed as percentage
- According to the IFCC reference ranges are the base standards
Coefficient of Variation (CV)
- Coefficient of Variation (CV) = Standard Deviation/ Samples mean
- An ideal range is less than 1.0 which indicates a better peer group
- Ratings at 1.5 indicate some precision, investigate the cause of data
- Readings at 2.0 indicate serious data error is present, investigate the cause of data
Standard Deviation Index (SDI)
- SDI = Laboratory mean - Consensus Group Mean/ Consensus GRP standard deviation
- Key Ranges:
- <1.25: Indicates acceptable results
- 1.5 - 1.99: Indicates an improper system. Investigation is essential
-
2.0: Indicates an unacceptable system. Remedial action is required
Reference Ranges
- Is control out of range?
- When a control is out of range
- Repeat the test using the same reagent
- Acknowledge this may be human or systemic error
Control Materials
- Specimens analyzed for quality purposes are known as that
- Should be available in a range of forms
Ranges of Control:
- Stable and easy to store
- Aliquots and vials
- Analyzed and quality assured
Types of Control Materials:
- Assayed control provides a mean by quality performance verified in the laboratory
- Unassayed- requires intensive data analysis
- In-house is pooled with character, and preserved
Managing Materials
- Material should be stable
- Procedures should be accurate
- Preservatives (chemicals, freezing, and even drying) are permissible
Calibrators
- Known concentration of a measure substance
- Used to stabilize testing
- Should not be considered control material
Control Charts
- Common measures to ensure performance
Important Points about Q.C Charts
- Graphically plots
- Points falling within quality, and limits of accurate reporting
Levy-Jennings Charts
- Displays process control, shows values
- Ensures high testing
Important features for graphs
- Auto generation capability
- Limit markers with color
Westgard Rules
- Generally where 2 levels of control material are analyzed
Components for These Processes
- 1,2,3s rule
- r, 4,10x rule
Key Westgard Factors
Westgard Warning
- Alerting
- Not necessarily a cause to reject
Westgard Rejection
- Sensitive system needs to be investigated quickly
- Cannot reject a run, a recheck is recommended to correct errors
Other Westgard Tests
- This test contains prior data
- Reagents that are accurate over a range
What to Do if QC Fails
- Change vial
- Remix reagents and retest
- Test new instruments
- Confirm data is correct and instrumentation
Other Testing
- Compare prior and existing records
- Understand standard readings
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