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MLS 4158 - Laboratory Management & Operations - Exam 2 Questions and Answers $12.99
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MLS 4158 - Laboratory Management & Operations - Exam 2 Questions and Answers
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MLS 4158 - Laboratory Management & Operations - Exam 2 Questions and Answers What are the 3 levels of quality? 1. Quality Control (QC) 2. Quality Assurance (QA) 3. Quality Improvement (QI) What is Quality Control? Method control that is an ongoing effort to maintain the integrity of...

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  • December 25, 2024
  • 61
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • mls 4158 laboratory management operations ex
  • describe the pre analytic step in the laboratory p
  • what is quality improvement deliberate change in

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  • Laboratory management
  • Laboratory management

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MLS 4158 - Laboratory Management &
Operations - Exam 2 Questions and
Answers
What are the 3 levels of quality? - answer 1. Quality Control (QC)

2. Quality Assurance (QA)

3. Quality Improvement (QI)

What is Quality Control? - answer Method control that is an ongoing effort to
maintain the integrity of the process and reliability of the outcome

What is Quality Assurance? - answer Process control of systematic actions that will
assure customers and instill confidence

What is Quality Improvement? - answer Deliberate change in the process to improve
reliability of achieving results

What are the 3 steps in the laboratory path of workflow? - answer 1. Preexamination
(Pre-analytic)

2. Examination (Analytic)

3. Postexamination (Post-analytic)

Describe the Pre-analytic step in the laboratory path of workflow. - answer Specimen
collection, transport, and quality

Describe the Analytic step in the laboratory path of workflow. - answer Result
accuracy

Clerical errors

Analytical errors

Assay repeat rates

Describe the Post-analytic step in the laboratory path of workflow. - answer Result
reporting

Record keeping for patient and QC

,Quality Control provides a degree of confidence in what? - answer Reproducibility of
results

Quality Control is a __________ control. - answer method

Quality Control is mostly useful in which part of the laboratory process? - answer
Analytical

What are the 3 QC requirements? - answer 1. Regulatory standards

2. Manufacturer recommendations

3. Accreditation requirements

Quality Assurance is about deliberate actions that ensure what? - answer That the
correct result is achieved in the standard, reproducible, and traceable manner

What does Quality Assurance measure? - answer The effect of activities across pre-
analytical, analytical, and post-analytical stages of laboratory path of workflow and
therefore it is all-encompassing

What does QA evaluate? - answer Entire workflow; process, people (training and
competency), and equipment

The Quality Management System (QMS) is the all-encompassing level of quality in the
laboratory. This concept was introduced by what? - answer Clinical & Laboratory
Standards Institute (CLSI)

CLSI guidance outlined 12 Quality System Essentials (QSE). What are they? - answer
1. Organization (OR)

2. Customer Focus (CF)

3. Facilities and Safety (FS)

4. Personnel (PE)

5. Purchasing and Inventory (PI)

6. Equipment (EQ)

7. Process Management (PM)

8. Documents and Records (DR)

,9. Information Management (IM)

10. Nonconforming Event Management (NC)

11. Assessments (AS)

12. Continual Improvement (CI)

QMS includes: - answer QC and QA, as well as management activities to oversee
both of these (planning)

QMS is a framework for outlining what? - answer Quality principles and practices into
every aspect of laboratory operations

Compliance is a requirement in order to maintain what? - answer Licensure

Compliance inspectors/surveyors/assessors measure what? - answer The state of
laboratory's program with respect to applicable standards and requirements

How often to compliance inspections occur? - answer Every 2 years

Compliance is achieved through what? - answer Robust Quality Control and Quality
Assurance that will allow you to detect the problem, correct it, and ensure it does not
occur again

Compliance inspections are periodic, but Quality Management (QM) is __________. -
answer continuous

Organization consists of what 4 parts of an organizational structure to ensure quality? -
answer 1. Laboratory's legal identity (licensure)

2. Functional work divisions and workgroups

3. Staff roles and responsibilities

4. Formal structures

Customer Focus consists of what 4 requirements? - answer 1. Identifying customer
and user expectations

2. Evaluating laboratory's capability to meet customer expectations

3. Measuring customer and user satisfaction

4. Recording and managing complaints

, What are the 2 types of customers in Customer Focus? - answer 1. External
Customer; patients, healthcare practitioners, other departments, other laboratories,
accreditation organizations, government agencies, insurance payers

2. Internal Customer; Medical Technologists, administration, support services

What are the goals for each customer (external and internal)? - answer 1. Know their
expectations

2. Can your laboratory meet these expectations?

3. Identify a way to measure customer satisfaction

What is the main customer expectation of the laboratory? - answer Information that
is accurate, interpretable, and timely

What are the key measures of Facilities and Safety? (6 of them) - answer 1. Effective
design and management of the physical environment

2. Assessment of risks

3. Adherence to all national, regional, and local requirements

4. Supporting safety programs

5. Training to the safety programs (new staff and refresher training)

6. Recording all training

A safety program is highly dependent of what? - answer Scope of work your
laboratory is performing

A safety program should address each aspect to ensure what? - answer That you
are providing a safe work environment

Example: Radiation safety may not need to be included for each lab depending on
scope of service

Name 7 types of safety programs for a laboratory. - answer 1. Biosafety

2. Chemical Hygiene

3. Occupational Health

4. Hazardous Waste Management

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