Podcast
Questions and Answers
What is necessary for a control to be considered fully validated?
What is necessary for a control to be considered fully validated?
- It must be prepared by external staff.
- It must be run at least 40 times in total.
- It must be run at least 20 times in a single run and then daily for 20 days. (correct)
- It must have a predetermined target value.
Which of the following accurately describes a calibrator?
Which of the following accurately describes a calibrator?
- A control with predetermined values established over varied conditions.
- A material that has an unknown concentration of analyte.
- A standard that has known concentrations of the analyte being measured. (correct)
- A sample from the patient's own blood.
What does a Levey-Jennings plot primarily evaluate?
What does a Levey-Jennings plot primarily evaluate?
- QC results for trends, shifts, and other variations. (correct)
- The reagent quality before its use in testing.
- The real-time performance of equipment during testing.
- The statistical significance between various test results.
Which function of quality control helps confirm testing accuracy?
Which function of quality control helps confirm testing accuracy?
What indicates a shift in quality control results?
What indicates a shift in quality control results?
Which of the following represents a common response to a QC alert?
Which of the following represents a common response to a QC alert?
What is the minimum score required for laboratories to be considered in compliance with proficiency testing on analytes?
What is the minimum score required for laboratories to be considered in compliance with proficiency testing on analytes?
Which of the following roles must be present in a highly complex laboratory that are not necessarily required in a moderately complex laboratory?
Which of the following roles must be present in a highly complex laboratory that are not necessarily required in a moderately complex laboratory?
What does the term 'un-assayed' refer to in quality control?
What does the term 'un-assayed' refer to in quality control?
What is the primary focus of lean thinking in continuous quality improvement?
What is the primary focus of lean thinking in continuous quality improvement?
Which process helps detect progressive drift in quality control results?
Which process helps detect progressive drift in quality control results?
Which statement best describes the function of proficiency testing in laboratories?
Which statement best describes the function of proficiency testing in laboratories?
What is necessary for continuous quality improvement (CQI) to be effective?
What is necessary for continuous quality improvement (CQI) to be effective?
How often do laboratories receive challenges for proficiency testing?
How often do laboratories receive challenges for proficiency testing?
What is the purpose of documenting corrective actions in a laboratory setting?
What is the purpose of documenting corrective actions in a laboratory setting?
Which of the following is NOT considered a synonym or process related to continuous quality improvement?
Which of the following is NOT considered a synonym or process related to continuous quality improvement?
Which of the following is NOT considered an engineering control to minimize exposure to pathogens?
Which of the following is NOT considered an engineering control to minimize exposure to pathogens?
What is the PRIMARY purpose of work practices developed in response to blood or PIM exposure?
What is the PRIMARY purpose of work practices developed in response to blood or PIM exposure?
Which of the following statements about housekeeping procedures is TRUE?
Which of the following statements about housekeeping procedures is TRUE?
What is a critical component of an HBV vaccination program for employees?
What is a critical component of an HBV vaccination program for employees?
Which of the following is an example of a work practice to reduce exposure to blood or PIMs?
Which of the following is an example of a work practice to reduce exposure to blood or PIMs?
Housekeeping personnel must handle contaminated materials with which of the following?
Housekeeping personnel must handle contaminated materials with which of the following?
Which of the following is NOT a potential hazard that engineering controls aim to isolate or remove?
Which of the following is NOT a potential hazard that engineering controls aim to isolate or remove?
What type of container must be used for the disposal of biohazard materials?
What type of container must be used for the disposal of biohazard materials?
What is a requirement for the manual to obtain approval?
What is a requirement for the manual to obtain approval?
Which of the following describes when the manual must be rewritten?
Which of the following describes when the manual must be rewritten?
What practice should laboratory personnel follow according to universal precautions?
What practice should laboratory personnel follow according to universal precautions?
What must a written exposure control plan include?
What must a written exposure control plan include?
What types of personal protective equipment (PPE) are considered appropriate?
What types of personal protective equipment (PPE) are considered appropriate?
What is included in the regulations concerning occupational exposure to bloodborne pathogens?
What is included in the regulations concerning occupational exposure to bloodborne pathogens?
What provides the basis for all preventive measures against bloodborne pathogens?
What provides the basis for all preventive measures against bloodborne pathogens?
Which of the following statements about personal protective equipment (PPE) is correct?
Which of the following statements about personal protective equipment (PPE) is correct?
Which term refers to the ability of a test to correctly identify those without the condition?
Which term refers to the ability of a test to correctly identify those without the condition?
What is the primary purpose of evaluation in an education unit?
What is the primary purpose of evaluation in an education unit?
Which of the following is NOT considered when ensuring quality standards?
Which of the following is NOT considered when ensuring quality standards?
In problem-solving, what is the first step in the defined process?
In problem-solving, what is the first step in the defined process?
Which category of learning outcomes focuses on attitudes and values?
Which category of learning outcomes focuses on attitudes and values?
What aspect is primarily concerned with the costs associated with software and hardware?
What aspect is primarily concerned with the costs associated with software and hardware?
Which of the following is an example of a psychomotor learning outcome?
Which of the following is an example of a psychomotor learning outcome?
What role does stability and availability of reagents play in quality standards?
What role does stability and availability of reagents play in quality standards?
What encompasses costs that remain unchanged regardless of the number of tests conducted?
What encompasses costs that remain unchanged regardless of the number of tests conducted?
Which type of cost relates directly to the materials and labor specifically involved in producing a test result?
Which type of cost relates directly to the materials and labor specifically involved in producing a test result?
What is NOT a benefit of a Laboratory Information System (LIS)?
What is NOT a benefit of a Laboratory Information System (LIS)?
What minimum requirement of an LIS ensures that each assay is uniquely identifiable?
What minimum requirement of an LIS ensures that each assay is uniquely identifiable?
Which cost category involves expenses related to long-term investments such as laboratory equipment?
Which cost category involves expenses related to long-term investments such as laboratory equipment?
Which document is essential for both external inspectors and internal staff to define the Quality Management System (QMS)?
Which document is essential for both external inspectors and internal staff to define the Quality Management System (QMS)?
What is the role of indirect costs in laboratory operations?
What is the role of indirect costs in laboratory operations?
Which of the following is a requirement for ensuring quality control and traceability in an LIS?
Which of the following is a requirement for ensuring quality control and traceability in an LIS?
Flashcards
Commercially available control
Commercially available control
A commercially available control with predetermined values for analytes.
Un-assayed control
Un-assayed control
A control that needs to be validated by running it multiple times to establish a target value.
Homemade control
Homemade control
A control prepared in the laboratory using pure materials dissolved in a liquid.
Calibrators (Standards)
Calibrators (Standards)
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Quality Control (QC)
Quality Control (QC)
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Levey-Jennings/Shewhart plot
Levey-Jennings/Shewhart plot
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QC alert
QC alert
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Corrective Action
Corrective Action
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Continuous Quality Improvement (CQI)
Continuous Quality Improvement (CQI)
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Quality circle
Quality circle
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LEAN THINKING
LEAN THINKING
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Proficiency testing
Proficiency testing
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Validation
Validation
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Calibrator
Calibrator
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Quality control
Quality control
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Records
Records
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Laboratory Manual
Laboratory Manual
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Manual Approval
Manual Approval
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Universal Precautions
Universal Precautions
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Exposure Control Plan
Exposure Control Plan
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Personal Protective Equipment (PPE)
Personal Protective Equipment (PPE)
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Appropriate PPE
Appropriate PPE
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Procedure Documentation and Review
Procedure Documentation and Review
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Manual Rewriting
Manual Rewriting
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Engineering Controls
Engineering Controls
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Work Practices
Work Practices
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Housekeeping Procedures
Housekeeping Procedures
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HBV Vaccination Program
HBV Vaccination Program
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Employer's Responsibility for PPE
Employer's Responsibility for PPE
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Potentially Infectious Materials (PIMs)
Potentially Infectious Materials (PIMs)
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Employer's Duty to Provide a Safe Workplace
Employer's Duty to Provide a Safe Workplace
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Goal
Goal
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Objective
Objective
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Cognitive Objective
Cognitive Objective
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Affective Objective
Affective Objective
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Psychomotor Objective
Psychomotor Objective
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Learning Activities
Learning Activities
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Evaluation
Evaluation
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Direct Costs
Direct Costs
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Indirect Costs
Indirect Costs
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Fixed Costs
Fixed Costs
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Variable Costs
Variable Costs
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Capital Costs
Capital Costs
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Laboratory Information System (LIS)
Laboratory Information System (LIS)
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Documents
Documents
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Quality Management System (QMS)
Quality Management System (QMS)
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Study Notes
Laboratory Management
- Management is defined as organizing and controlling the affairs of a business or sector. It is "working with and through people to accomplish a common mission."
- Key factors in leadership success include management style. There are five primary leadership theories:
- Tannenbaum and Schmidt: Styles range from authoritative to democratic, plotted on a continuum.
- McGregor X and Y: McGregor X theory represents authoritative leadership; Y theory is democratic.
- Blake and Mouton: Describes five management situations, from impoverished (low concern for people and production) to team-focused (high concern for both).
- Fielder: Leader style varies by situation's favorability, with task-oriented leaders needed in highly favorable or unfavorable situations and relationship-oriented leaders in moderately favorable or unfavorable ones.
- Hersey-Blanchard: Four leadership situations depending on employee experience (new to job, mastered some of the job, verified mastery, confident mastery).
- Manager skills include:
- Organizational skills: Conceptualizing, applying management processes, and communicating effectively.
- People skills: understanding human needs and motivations
- Financial skills: Effectively using and accounting for the company's funds.
- Technical skills: Utilizing physical resources (supplies, equipment, facilities) within operational parameters.
- Management theories include:
- Scientific Management (Frederick Taylor): Analyzing tasks to improve efficiency by segmenting.
- Bureaucracy Management: Focuses on organizational structure, flow, hierarchical chain of command.
- Behavioral Science: Interaction of employees within the organization, utilizing psychology and sociology.
- Systems Analysis: Views organizations as a system interacting with the environment. • Five basic management operations (Drucker): Setting objectives, organizing, motivating/communicating, developing people (managers included), adapting.
Management Process
- Management as a continuous process of interacting functions for success
- Planning (determining the organization's mission and goals, SWOT analysis), Organizing (forming a structure to execute plans), Directing (persuading employees), Controlling.
Planning
- Develop a pathway for achieving organizational mission and goals using resources and time.
- SWOT analysis: Examining internal strengths/weaknesses and external opportunities/threats.
- Formulating goals and objectives: Broad goals, written objectives for specific tasks.
- Short-range/tactical plans (1-5 years), Operational plans (one budget period), Strategic plans (20+ years).
Organizing (Time Management)
- Laboratorians' work is dictated by healthcare system demands.
- Managers have flexibility to plan work, but must identify, control, and eliminate time-wasting activities.
- Identifying important tasks is essential to allocate time effectively.
Directing (Motivating and Delegation)
- Leaders influence and motivate employees to complete tasks.
- Directing methods include authoritative (direct orders), coaching (involving/motivating), and empowering (autonomy to accomplish tasks).
- Delegating duties: Assigning responsibility, authority, and accountability.
Communication
- Face-to-face: Advantages of immediate feedback, identifying non-verbal cues; disadvantages of not being able to save the conversation, misinterpretations due to non-verbal cues.
- Written: Advantages of being able to save, distribute, revisit, advantages for clarifying and adding details, disadvantages of being impersonal, potentially delayed feedback.
- Listening: Active listening is crucial for receiving and interpreting meanings effectively, including mental and emotional barriers.
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Description
Test your knowledge on the principles and practices of quality control in laboratory environments. This quiz covers various aspects including calibration, proficiency testing, and continuous quality improvement. Perfect for students and professionals involved in laboratory work.
