Quality Management, Quality Assurance, And Quality Control In Clinical Laboratory

Front 1

Refers to the degree to which a set of inherent characteristics of a product, services, or process fulfills requirements and meets established standards

Back 1

quality

Front 2

Closeness (mv) to (rv)

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accuracy

Front 3

Ability of a laboratory to consistently produce accurate and precise results

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reliability

Front 4

Capability to link measurements results to ensure validity

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traceability

Front 5

adherence to establish standards, protocols and regulations relevant to lab activities

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compliance

Front 6

to ensure accurate and reliable results

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calibration and maintenance

Front 7

accuracy + precision

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reliability

Front 8

Records and data

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documentation

Front 9

Refers to the overall process used to ensure that laboratory results meet the requirements for health care services to patients

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quality management system

Front 10

12 quality system essentials

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- organization

- customer focus

- facilities and safety

- personnel

- purchasing and inventory

- equipment calibration and maintenance

- process management

- documents and records

- information management patient and sample identifier

- nonconforming event management

- assessment

- continuous improvement

Front 11

Leadership and management

Back 11

organization

Front 12

Survey and feedback

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customer focus

Front 13

Lab design, floor plan and measurements

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facilities and safety

Front 14

RMT, CMT, HOL (pathologist), lab analyst and lab tech

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personnel

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Reagents and calibrators

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purchasing and inventory

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QA & QC

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process management

Front 17

Laboratory Information Management System (LIMS)

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information management patient and sample identifier

Front 18

Any events that have a negative impact must be corrected

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nonconforming event management

Front 19

PT/EQA

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assessment

Front 20

to check the reliability of a laboratory

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assessment

Front 21

Plan, Do, Check, Act (PDCA), Six Sigma and LEAN

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continuous improvement

Front 22

It is a process that focuses on providing assurance that quality requested will be achieved and attained the best possible product or service to patients

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quality assurance

Front 23

quality assurance measure designed to ensure that laboratories procedure are accurate and reliable results

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proficiency testing

Front 24

Laboratory must support an optimal path of workflow by allowing processes that yield efficient sample handling while minimizing error

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path of workflow

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✓ Specimen handling, collection and transport

✓ Patient preparation

✓ Fasting FBS (6-8HR) TAG (12-14HR) CHOL (8-10HR, No Fasting)

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pre-analytical

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Testing process

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analytical

Front 27

Recording results and data interpretation

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post analytical

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A process to periodically examine a measurement procedure to verify that it is performing according to preestablished specifications

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quality control

Front 29

✓ Measures the analytical phase (process flow)

✓Post analytical phase

✓Qc sample are measured as same manner as clinical samples (patient samples)

✓Qc sample (manmade)

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quality control

Front 30

✓Background component of sample other than the test to perform

✓CSF

✓Urine

✓Serum

✓Plasma

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matrix

Front 31

✓New batch rgts

•Solution of known concentration

•Must have the same matrix as sample

•Can be run in single or multiple parameters

•Has to be purchased separately

•Expensive

✓Liquid

✓Lyophilized (powder)

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calibrators

Front 32

•Solution of known concentration

•Matrix may or may not be the same as sample

•Provided with kit

•Cost effective

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standards

Front 33

•Substance having similar composition as sample used to monitor the status of analysis

•Matrix is the same with the sample

•Test if the analyzer after calibration is giving satisfactory results or not

•They have value in range (low, normal, high)

•Can be obtained from the reagents or instrument supplier or third party control

•IQC daily

•EQC once a month

Back 33

control

Front 34

Essential in laboratory analyses, helping to identify, quantify, or modify the properties of substances

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reagent

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differs depending on the test being performed

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reagents

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•Substances of interest being analyzed or measured

•Hema

•CC

•CM

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analyte

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goal of quality control

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•Providing laboratory with confidence by:

1.Detecting errors

2.Evaluating errors

3.Correcting errors

Front 38

goal of quality control is to provide laboratory with confidence by:

1. Detecting errors

2. Evaluating errors

3. Correcting errors

due to:

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1.System failure

2.Environmental conditions

3.Operator performance (rmt)

= before reporting the patient results

Front 39

Most common presentation for evaluating QC results

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levy jennings chart

Front 40

Allows a quick visual assessment of method performance, including trend detection

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levy jennings chart

Front 41

represents the target (or expected) value for the result, and SD lines represent the expected imprecision for the method

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mean value