Quality Control in Laboratory Settings

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Questions and Answers

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?

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?

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?

Comparison with reference values Signup and view all the answers

What indicates a shift in quality control results?

An abrupt change in value for three consecutive days. Signup and view all the answers

Which of the following represents a common response to a QC alert?

Re-evaluating the control materials used. Signup and view all the answers

What is the minimum score required for laboratories to be considered in compliance with proficiency testing on analytes?

80% Signup and view all the answers

Which of the following roles must be present in a highly complex laboratory that are not necessarily required in a moderately complex laboratory?

General supervisor Signup and view all the answers

What does the term 'un-assayed' refer to in quality control?

A control where the target value is not predetermined. Signup and view all the answers

What is the primary focus of lean thinking in continuous quality improvement?

Removing waste Signup and view all the answers

Which process helps detect progressive drift in quality control results?

Analysis over a period of at least three days. Signup and view all the answers

Which statement best describes the function of proficiency testing in laboratories?

It evaluates the testing processes for accuracy against those of other facilities. Signup and view all the answers

What is necessary for continuous quality improvement (CQI) to be effective?

Commitment from top management Signup and view all the answers

How often do laboratories receive challenges for proficiency testing?

Every three months Signup and view all the answers

What is the purpose of documenting corrective actions in a laboratory setting?

To improve testing processes and resolve problems Signup and view all the answers

Which of the following is NOT considered a synonym or process related to continuous quality improvement?

Financial Auditing (FA) Signup and view all the answers

Which of the following is NOT considered an engineering control to minimize exposure to pathogens?

Protective clothing Signup and view all the answers

What is the PRIMARY purpose of work practices developed in response to blood or PIM exposure?

To eliminate or reduce employee exposure Signup and view all the answers

Which of the following statements about housekeeping procedures is TRUE?

All equipment must be decontaminated regularly. Signup and view all the answers

What is a critical component of an HBV vaccination program for employees?

Availability for employees exposed to PIMs Signup and view all the answers

Which of the following is an example of a work practice to reduce exposure to blood or PIMs?

No recapping of contaminated needles Signup and view all the answers

Housekeeping personnel must handle contaminated materials with which of the following?

Personal protective equipment (PPE) Signup and view all the answers

Which of the following is NOT a potential hazard that engineering controls aim to isolate or remove?

Ergonomic issues Signup and view all the answers

What type of container must be used for the disposal of biohazard materials?

Puncture-resistant containers Signup and view all the answers

What is a requirement for the manual to obtain approval?

It must be signed by the laboratory director. Signup and view all the answers

Which of the following describes when the manual must be rewritten?

When new procedures are implemented. Signup and view all the answers

What practice should laboratory personnel follow according to universal precautions?

They should treat all human blood as if infected with HIV and HBV. Signup and view all the answers

What must a written exposure control plan include?

Identification of job classifications that may have exposure risks. Signup and view all the answers

What types of personal protective equipment (PPE) are considered appropriate?

Gowns, gloves, masks, and eye protection. Signup and view all the answers

What is included in the regulations concerning occupational exposure to bloodborne pathogens?

Limitations on occupational exposure to potentially infectious materials. Signup and view all the answers

What provides the basis for all preventive measures against bloodborne pathogens?

The practice of universal precautions. Signup and view all the answers

Which of the following statements about personal protective equipment (PPE) is correct?

PPE must be provided to employees at no cost. Signup and view all the answers

Which term refers to the ability of a test to correctly identify those without the condition?

Specificity Signup and view all the answers

What is the primary purpose of evaluation in an education unit?

To provide feedback on learner’s attainment Signup and view all the answers

Which of the following is NOT considered when ensuring quality standards?

Cost of delivery Signup and view all the answers

In problem-solving, what is the first step in the defined process?

Define the problem Signup and view all the answers

Which category of learning outcomes focuses on attitudes and values?

Affective Signup and view all the answers

What aspect is primarily concerned with the costs associated with software and hardware?

Instrument itself Signup and view all the answers

Which of the following is an example of a psychomotor learning outcome?

Building a model Signup and view all the answers

What role does stability and availability of reagents play in quality standards?

It affects the accuracy of results. Signup and view all the answers

What encompasses costs that remain unchanged regardless of the number of tests conducted?

Fixed Costs Signup and view all the answers

Which type of cost relates directly to the materials and labor specifically involved in producing a test result?

Direct Costs Signup and view all the answers

What is NOT a benefit of a Laboratory Information System (LIS)?

Increases laboratory costs Signup and view all the answers

What minimum requirement of an LIS ensures that each assay is uniquely identifiable?

Unique accession number Signup and view all the answers

Which cost category involves expenses related to long-term investments such as laboratory equipment?

Capital Costs Signup and view all the answers

Which document is essential for both external inspectors and internal staff to define the Quality Management System (QMS)?

Process flowcharts Signup and view all the answers

What is the role of indirect costs in laboratory operations?

Support the testing environment Signup and view all the answers

Which of the following is a requirement for ensuring quality control and traceability in an LIS?

Recording time collected and identifiers Signup and view all the answers

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.