Quality Management Flashcards

1
Q

What is quality assurance?

A

Providing confidence that Quality requirements will be met through formal processes of:
* Quality Control.
* External Quality Assessment.
* Internal Quality Assessment.
To maintain integrity and accuracy of all lab testing systems.

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2
Q

What is Quality Control?

A
  • Operational techniques and activities that assess the performance of a testing system in real time and compares it to previously accepted performance criteria.
  • Verifies test is working properly.
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3
Q

What are the aims of Quality Control?

A
  • Detect deficiencies.
  • Reduce deficiencies.
  • Correct deficiencies.
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4
Q

What are examples of Quality Control

A
  • Instrument standardisation checks.
  • Instrument maintenance.
  • Analysis of control material
  • Statistical or graphical assessment of results from control material.
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5
Q

What is External Quality Assessment / Assurance?

A
  • External to the lab.
  • Ensures all labs testing the same sample will get the same result.
  • Required for lab accreditation.
  • E.g. RCPA Quality Assurance Program
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6
Q

What is Internal Quality Assessment / Assurance?

A
  • Internal to the lab.
  • Monitors performance within the lab.
  • Drives improvements within the lab.
  • Supports ongoing professional practice.
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7
Q

What are examples of Internal Quality Assurance?

A
  • Audits.
  • Quality Improvement
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8
Q

What are audits?

A
  • Systematic.
  • Independent.
  • Gathers objective evidence.
  • Determines whether specified criteria are being met.
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9
Q

What is Quality Improvement?

A
  • Continuously assessing and adjusting performance using statistically and scientifically accepted procedures.
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10
Q

What are the Five rights?

A
  • Right test.
  • Right result.
  • Right patient.
  • Right doctor.
  • Right time.
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11
Q

What is the Right Test?

A
  • Most suitable.
  • Most cost-effective.
  • Provides reliable and clinically relevant results.
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12
Q

What is the Right Result?

A
  • Test that gives the right answer.
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13
Q

What does the right result require?

A
  • Unambiguous methods.
  • Reagents in date.
  • Operators know and adhere to the method.
  • Accurate documentation of results.
  • Testing of known samples.
  • Assurance of analytical quality through internal quality control, external quality assessment / assurance and clinical validation.
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14
Q

What are the requirements for the right patient?

A
  • Three identifiers.
  • A unique lab number for each specimen.
  • Checking that specimen details match those on the request form.
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15
Q

What is the right doctor?

A
  • The results are recevied by the correct doctor in a clinically useful format.
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16
Q

What is the right time?

A
  • Results provided in a clinically useful timeframe.
  • Results acted upon in a timely and appropriate manner.
17
Q

What is Pre-analytical

A