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Quality Management Flashcards

(73 cards)

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1
Q

What are the Coru standards of proficiency for medical scientists?

A
  1. Professional autonomy & accountability
  2. Communication, collaborative practice and teamworking
  3. Safety and quality
  4. Professional development
  5. Professional knowledge and skills
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2
Q

What must medical laboratories provide to ensure patient safety and care?

A

High quality service by producing accurate, precise, relevant and comprehensive test results

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3
Q

What is required for accurate diagnosis in patient care?

A

Accurate test results

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4
Q

What are the economic benefits of a quality service in medical laboratories?

A
  • Efficient
  • Value for money (VFM)
  • Reduced waste
  • Fewer unnecessary tests
  • Fewer repeat tests due to errors
  • Prevention of litigation
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5
Q

What does a Quality Management System (QMS) focus on?

A

Achieving quality policy and quality objectives

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6
Q

Who are considered customers in the context of a Quality Management System?

A
  • The patient
  • Clinicians
  • Other hospitals
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7
Q

Why are accurate and precise results essential in clinical settings?

A

For correct diagnosis and safe management of patients

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8
Q

What can a laboratory error lead to?

A

Misdiagnosis with serious clinical consequences

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9
Q

What are the potential consequences of poor performance in medical laboratories?

A
  • Misdiagnosis
  • Delayed/inappropriate treatment
  • Increased costs
  • Potentially life-threatening situations for the patient
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10
Q

What should laboratory results and interpretations ensure for patient care?

A

Interchangeability within and between institutions

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11
Q

Fill in the blank: A Quality Management System is a collection of business processes focused on achieving your _______.

A

[quality policy and quality objectives]

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12
Q

What is the primary purpose of Quality Assurance (QA) in clinical laboratories?

A

To provide precise and accurate analyses to support optimal patient care.

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13
Q

How does QA improve test reliability?

A

By minimizing variability arising from biological or analytical sources.

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14
Q

What does QA seek to guarantee in laboratory testing?

A

The right result from the right test, at the right time, on the right specimen from the right patient, interpreted using the right reference data.

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15
Q

Define Quality Assurance.

A

An overall management plan to guarantee the integrity of data.

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16
Q

Define Quality Control.

A

A series of analytical measurements used to assess the quality of the analytical data.

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17
Q

What are the three separate QA activities undertaken by laboratories?

A
  • IQC
  • EQA
  • Quality Management System compliant with ISO15189.
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18
Q

What is the frequency range of pre-analytical lab errors?

A

46-68%.

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19
Q

What is the frequency range of analytical lab errors?

A

8-17%.

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20
Q

What is the frequency range of post-analytical lab errors?

A

18-47%.

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21
Q

List the components of the Pre-analytical Stage.

A
  • Sample collection
  • Type of sample, positive patient ID, patient consent
  • Sample preparation
  • Transport/collection medium, sample transportation, agitation, temperature, time
  • Sample reception
  • Verify correct patient, allocation of lab number
  • Training, instruction, monitor
  • Competency logs.
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22
Q

What is the purpose of the analytical stage in laboratory processes?

A

To validate equipment and methods, test methods, and monitor results through quality control

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23
Q

What components are included in the analytical stage?

A
  • Scientific and technical aspects
  • Test methods
  • Validates equipment, method
  • Batch accepted reagents
  • Monitoring of results (QC)
  • Internal QC
  • External QC
  • Standard operating procedures
  • Troubleshooting
  • Trained + competent staff
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24
Q

What is involved in the post-analytical stage of laboratory processes?

A
  • Issuing of results
  • Report format
  • Interpretation of results
  • Reference ranges for analyte
  • Timely manner – Turnaround time (TAT)
  • Sample retention
  • Training, instruction, monitor – competency logs
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25
Quality applies to which areas in a laboratory setting?
* Organisation/Hospital * Management * Facilities/Environment * Equipment * Reagents * Documentation/Record keeping * Staff * Training * Communication
26
What is the focus of quantitative quality control?
To measure the quantity of an analyte with numeric values and units of measurement
27
Which fields typically utilize quantitative quality control?
* Clinical chemistry * Haematology
28
What does qualitative quality control evaluate?
The presence or absence of a substance or cellular characteristics
29
How is qualitative quality control expressed?
* Positive/negative * Normal/abnormal * Growth/no growth
30
Which fields typically utilize qualitative quality control?
* Cellular Pathology * Microbiology * Transfusion science * Haematology
31
Fill in the blank: The _______ stage involves issuing results and interpretation of results.
[post-analytical]
32
True or False: Quality control is only relevant to laboratory equipment.
False
33
What is meant by 'Turnaround time (TAT)' in the context of laboratory results?
The timely manner in which results are issued
34
Fill in the blank: Internal and external _______ are components of quality control.
[QC]
35
What does IQC stand for?
Internal Quality Control
36
What is the primary purpose of IQC?
To monitor the analytical phase of testing
37
What does IQC aim to detect and correct?
Errors due to test system failure, environmental conditions, or operator performance before patient results are reported
38
How does IQC assess the performance of an analyser or meter?
In real time
39
What are the objectives of IQC?
To achieve precision and accuracy with the tests performed
40
What is crucial for the success of a quality control procedure in IQC?
The selection of appropriate IQC material
41
What must the levels of control span in IQC?
Clinically relevant concentrations of the analyte
42
What does EQA stand for?
External Quality Assessment
43
What is the aim of EQA?
To ensure test results are reliable and comparable no matter where they are performed
44
What is an example of an EQA scheme in the UK?
NEQAS
45
What is an example of an EQA scheme in Finland?
IEQAS
46
How often are clinical laboratories sent samples for EQA?
On a regular basis
47
What is the participant unaware of during EQA testing?
What results to expect from the analysis
48
Who rates the results returned in EQA?
The EQA scheme organiser
49
What must the target value in EQA be determined by?
A reference laboratory or may be a consensus value
50
What type of report do EQA centres provide?
A report that compares the participant’s performance with that of all laboratories and/or groups of laboratories using the same test methods
51
What are the benefits of EQA?
* Comparison of performance and results with other participants * Early warning for systemic problems * Objective evidence of testing quality * Identifies areas for improvement * Identifies training needs * Educational * Corrective action ## Footnote EQA is required for accreditation
52
How is the Quality system within the laboratory maintained?
* Maintenance of the Quality Management System * Adherence to Standard Operating Procedures (SOPs) * Validation of methods and instruments * Part-taking in EQA schemes * Maintenance of IQC records * Maintenance of Training and Training records for all staff * Auditing of all processes within the laboratory * Raising and resolving non-conformances * Risk Assessment ## Footnote None
53
What are the Quality Specific Processes?
* Risk assessment * Recording failures as non-conformances * Auditing * Monitoring quality indicators (e.g. TAT) * Continuously review the effectiveness of the QMS * Training and competency records ## Footnote None
54
What is the purpose of auditing in the laboratory?
To review whether IQC and EQA success is regularly achieved ## Footnote Audits can be internal or external
55
What does auditing ensure?
* Compliance with accreditation (ISO15189) * Compliance with legislation * Compliance with laboratory quality management system * Gather information/evidence of compliance/non-compliance ## Footnote None
56
Fill in the blank: EQA is required for _______.
[accreditation]
57
True or False: Auditing helps identify whether controls are adequate and implemented.
True ## Footnote None
58
What is external auditing?
INAB, HIQA, HPRA, EFI
59
What are the two types of internal auditing?
* Reactive = complaint * Proactive = vertical, horizontal, witness, procedure, TAT
60
What is a vertical audit?
A detailed check that all the elements associated with a chosen process/test are implemented, following a sample through the Laboratory from the Patient to the Report.
61
List the steps involved in a vertical audit.
* Retrieve the request form & locate the specimen * Check IQC & EQA * Verify equipment maintenance * Training records of staff * The report * TAT
62
What is a horizontal audit?
A detailed check of a particular standard and its implementation, looking at a particular stage in processing.
63
What are the examples of checks in a horizontal audit?
* Installation/Validation documentation * Service records * Cleaning/decontamination records * Training & competency records
64
What is an examination audit?
An audit that can test competency of staff in a particular procedure by overseeing them performing the task.
65
How often must competency records be renewed?
Every 2 years at a minimum
66
What should a risk assessment do before implementing a new procedure?
Assess any 'high risks' prior to implementation.
67
What are Non-conformances?
Errors that occur, categorized as either technical or human.
68
What is a near-miss?
An event that has no clinical significance to the patient.
69
What is the purpose of Corrective Action (CA)?
To rectify the error.
70
What is the purpose of Preventative Action (PA)?
To prevent the re-occurrence of an error.
71
Give examples of non-conformances that can impact patients.
* Wrong bottle used * Sample mislabelled * Analyser error * QC failure * EQA failure * Results misinterpreted * Staff not competent
72
What is Q-Pulse?
Quality Management Information System that allows a Laboratory to maintain and improve Quality Management Processes.
73
List some Quality Management Processes that Q-Pulse helps maintain.
* Document control * Audits * Incident & risk management * Corrective and preventative action * Quality improvement

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