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Quality Management in the Medical Laboratory Questions and Answers
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Quality Management in the Medical Laboratory Questions and Answers Defn Quality The degree to which a product or service meets requirements Quality Control Provides a high degree of confidence that testing and examination results are accurate for the batch of samples being tested or exami...

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  • December 29, 2024
  • 4
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • quality management in the medical laboratory quest
  • quality control provides a high degree of confiden
  • quality assurance set of planned actions to provid

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  • Laboratory management
  • Laboratory management

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Quality Management in the Medical
Laboratory Questions and Answers
Define Quality - answer the degree to which a product or service meets requirements

Quality Control - answer Provides a high degree of confidence that testing and
*examination* results are accurate for the batch of samples being tested or examined
*at that time*
It monitors the *analytic* method

Quality Assurance - answer Set of *planned* actions to provide confidence that
processes other than testing that *influence* the quality of the laboratory's results and
reports are working as expected, individually and collectively.
Looks *beyond* the performance of just the test *method* or piece of equipment to
assess how well the laboratory's *entire workflow* is functioning

Quality Management System - answer Encompasses *all the management activities*
needed to ensure that the laboratory's workflow proceeds smoothly to provide
laboratory services to customers and patients
12 Quality Systems Essentials *[QSEs]* represents a way to *organize* all the *policies,
processes, and procedures* that any laboratory needs to meet all requirements of U.S.
laboratory regulatory and accreditation organizations. This guideline has been published
by the Clinical and Laboratory Standards Institute [CLSI]

Compliance w/ requirements *Versus* Quality Management - answer *Compliance*
simply requires the *correction* of identified *deviations* and *deficiencies* and usually
leaves the laboratory with the *false* sense that it has solved its problems and has been
brought into compliance
Participation in compliance inspections is a *periodic* activity; whereas, quality
management [QM] is *actively and continuously* practiced by the laboratory
In QM organizations, quality is everyone's job all the time

Organization - answer The laboratory should state in writing *its policies, goals, and
objectives* for each of the QMS essentials and relate them to the bigger organization's
quality goals

Customer Focus - answer Having a customer focus means understanding the
customer's *expectations* and designing the laboratory's workflow to *meet* those
expectations
Identify all customers, *internal* and *external*

Facilities & Safety - answer Laboratory's allocated space should be designed to
provide for *efficient workflow* and *effective ergonomics*

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