Lab Management 4 Stage Week / 9 20 - 24/ 4 /2024 Med Lab QC

Subject :- Lab Management
Level :- 4th Stage

Number of week :- Week / 9
Date :- 20 – 24/ 4 /2024
Title of lecture :- Med Lab QC
Dhary Alewy
Medical Laboratory Quality Control
-- Medical laboratory quality control refers to the processes and

procedures put in place to ensure that the results generated by
laboratory tests are accurate, reliable, and consistent.
-- QC measures are essential in medical laboratories to maintain

high standards of performance and to ensure patient safety.
-- It involves systems that safeguard the accuracy, reliability, and

timeliness of lab results by ensuring the early detection of results or
measurement errors and the procedures to rectify them.
-- The principles of quality assurance, quality control, and quality
management are bases for good laboratory results and workings.
-- Every test in the laboratory gives a result. To be sure about the
accuracy of the result is not possible until it is verified by some
means. It is the QC that will give confidence about the result.
-- This is the duty of the technicians to be sure about the accuracy
of the test result.
Purposes of Quality Control
1- To maintain a continuous record of precision of the tests.
2- It gives an early warning of the control trends.
3- It provides valid judgment on the accuracy of results by
comparison with the known sera.
4- Important for automated analysers to check their performance.
5- Monitor the analytic process and help to find which method is
more accurate.
6- This also helps to evaluate the technologist’s skills.
7- Determine analytical errors during analysis.
8- Prevent incorrect patient values.
Components of Quality Control
I:- Pre-analytical Phase

-- This involves procedures before testing , such as the following :-
1- Patient identification.
2- Sample collection.
3- Transportation of samples.
4- Preparation of the samples.
-- QC measures here ensure sample safety and proper handling of

the samples.
II:- Analytical Phase
-- This encompasses the actual testing process, including the
following processes:-
1- Instrument calibration.
2- Reagent preparation.
3- Sample analysis.
4- Result interpretation.
-- QC measures involve regular calibration checks, running control

samples, and verifying instrument performance.
III:- Post-analytical Phase
-- The post-analytical Phase involves the following processes:-
1- Result validation.
2- Reporting of the results.
3- Interpretation the results.
-- QC measures ensure accurate result reporting and appropriate

action upon facing differences.
-- Laboratory quality control ( LQC ) is designed to detect, reduce,
and correct deficiencies in a laboratory's internal analytical process
before the release of patient results, to improve the quality of the
results reported by the laboratory.
Standard Operating Procedures (SOPs)
Instrument Calibration and Maintenance
-- Regular calibration and maintenance of laboratory instruments
are essential to ensure accurate and reliable results.
-- The Instruments should be calibrated according to manufacturer
recommendations , and routine maintenance schedules should
be followed.
Types of Quality Control
-- Two types of QC can be distinguished ,which include :-
- Internal QC comprises procedures that are introduced within the

field laboratory.
- External QA involves external monitoring such as the duplicate

testing of samples in another reference laboratory to serve as a
‘gold standard’ or ‘blind’ measurement in the field laboratory of a
set of samples provided by an external reference laboratory.
Internal Quality Control / IQC
-- IQC involves the regular monitoring of testing procedures using
control materials of known concentrations.
-- It helps detect random errors and ensures the reliability of test

results within a laboratory.
-- QC which includes internal and external QC describes a set of

procedures used to check if laboratory results are reliable for the
intended clinical use.
-- Internal quality control (IQC) ensures day-to-day laboratory

consistency.
Internal Quality Control (IQC)
-- IQC involves the daily monitoring of test results using control
materials of known values.
-- IQC in medical laboratories is a crucial component of ensuring

accurate and reliable test results.
-- IQC involves procedures and measures implemented within lab to

monitor and maintain quality of testing processes and results.
-- By implementing strong IQC measures, med labs can ensure the

accuracy, reliability, and consistency of their test results.
How IQC is Conducted in Med Labs
1- Establishment of Quality Control Procedures
-- The laboratory should have documented procedures for IQC,
including criteria for acceptance or rejection of results.
2- Selection of Control Materials

-- These materials should cover the range of analyte concentrations
expected in patient samples and be stable under storage conditions.
3- Frequency of Testing
-- Control materials should be tested at regular intervals, typically at
the beginning of each testing run, and periodically during the day.
4- Monitoring Performance
-- Lab should monitor the performance of each analytical system
and assay by analyzing control materials beside patient samples.
5- Data Analysis
-- Using statistical methods to identify any patterns or trends
indicating a deviation from expected performance.
6- Troubleshooting and Corrective Action

-- When deviations from expected performance are detected, the
lab should study the cause and take appropriate corrective action.
7- Documentation and Record-Keeping

-- Should be documented and retained as part of the laboratory's
quality management system.
8- Participation in External Quality Assurance Programs

-- Helps to validate the accuracy and reliability of the laboratory's
testing procedures.
External Quality Assurance / EQA
-- EQA involves the participation of laboratories in proficiency

testing programs provided by external agencies.
--It allows laboratories to compare their performance with peers

and identify areas for improvement.
-- The term external quality assessment (EQA) is used to describe a

method that allows for comparison of a laboratory's testing to a
source outside the laboratory.
Importance of External Quality Assurance / EQA
-- External quality assurance is crucial in various fields, ensuring

that products, services, or processes meet established standards
and fulfill their intended purposes.
-- Overall, EQA plays a vital role in ensuring that organizations

deliver high-quality products, services, and processes that meet the
needs and expectations of stakeholders while maintaining
compliance with relevant standards and regulations.
1- Impartial (Neutral) Assessment
-- EQA provides unbiased evaluation of services,and processes.
2- Ensuring Compliance(Agreement)
-- Compliance is essential for maintaining legality, safety, and ethical
standards.
3- Enhancing Credibility(Reliability)
-- External validation adds credibility to the assessed entity.
4- Identifying Improvement Areas

-- External assessors bring fresh viewpoints and expertise to the
evaluation process, identifying areas for improvement that may have
been overlooked internally.
5- Benchmarking Performance
-- EQA allows organizations to standard their performance against
industry standards and competitors.
6- Building Trust
-- External quality assurance builds trust among customers,
employees, investors, and the public.
7- Supporting Innovation
-- EQA can support innovation by providing feedback on new
processes, products, or services.
8- Facilitating Collaboration
-- EQA often involves collaboration between different stakeholders
(sponsors) ,such as regulators, industry experts, and the
organization being assessed.
Quality Management Systems / QMS
-- QMS refers to the systematic approach to managing quality in all
aspects of laboratory operations.
-- It includes document control, personnel training, equipment

maintenance, and continuous improvement processes.
-- Quality management systems in laboratories assure the reliability

of all aspects of the operations.
-- QMS in med labs requires quality in all practices including

environment, quality procedures, record keeping, human resources,
reagents, and equipment and instruments.
What are the benefits of Quality Control
-- Quality control offers numerous benefits for businesses across
various industries.
Benefits of Quality Control in Med Labs
1- Accurate Diagnosis
-- QC measures help to ensure that test results are accurate and
reliable, leading to correct diagnoses.
2- Patient Safety
-- By maintaining high standards of quality, laboratories can
minimize the risk of misdiagnosis or incorrect treatment.
3- Compliance with Regulations

-- Med labs subject to strict regulations &accreditation standards.
4- Reduced Errors and Waste

-- QC helps to identify errors early in the testing process, minimizing
the probability of incorrect results.
5- Enhanced Confidence in Results
-- When patients and healthcare providers trust the accuracy and
reliability of laboratory test results.
6- Continuous Improvement
-- Allows laboratories to continually improve their processes,
equipment, and personnel training to enhance quality & efficiency.
7- Standardization
-- QC measures help to standardize testing procedures and ensure
uniformity across different laboratory locations and personnel.
8- Cost-Effectiveness
-- It leads to cost savings by reducing errors, rework, and the need
for additional testing.
9- Risk Management
-- QC helps laboratories identify and ease risks associated with
testing processes, equipment malfunction, or human error.
10- Professional Reputation

-- Healthcare providers, patients, and regulatory bodies are more
likely to trust and rely on laboratories with a reputation for
consistently delivering accurate and reliable results.
Outline / Week 9
Q1- Write in detail about the Components of Quality Control.
Q2- How is IQC conducted in med labs?
Q3- Clarify the benefits of quality control in med labs.
Q4:- Fill in the Blanks question.

1- The importance of EQA comprises.............
2- Purposes of Quality Control are .............
3- Types of Quality Control involves .............
Q5:- Answer the following statements with True or False and correct the false one.
1:- There is no relation between calibration of lab instruments and reliable results.
2:- QMS in med labs does not require quality in practice.
3:- The principles of QA, QC, and quality management are bases for collaborations.
4:- QC measures are essential in med labs to maintain high standards of performance.
5:- QC gives confidence about the result.
6:- LQC is designed to reduce and correct deficiencies in the analytical process.
THANK YOU SO MUCH

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Subject :- Lab Management

Level :- 4th Stage

-- Medical laboratory quality control refers to the processes and

-- QC measures are essential in medical laboratories to maintain

-- It involves systems that safeguard the accuracy, reliability, and

I:- Pre-analytical Phase

-- QC measures here ensure sample safety and proper handling of

-- QC measures involve regular calibration checks, running control

-- The post-analytical Phase involves the following processes:-

2- Reporting of the results.

3- Interpretation the results.

-- QC measures ensure accurate result reporting and appropriate

- Internal QC comprises procedures that are introduced within the

- External QA involves external monitoring such as the duplicate

-- It helps detect random errors and ensures the reliability of test

-- QC which includes internal and external QC describes a set of

-- Internal quality control (IQC) ensures day-to-day laboratory

-- IQC in medical laboratories is a crucial component of ensuring

-- IQC involves procedures and measures implemented within lab to

-- By implementing strong IQC measures, med labs can ensure the

2- Selection of Control Materials

6- Troubleshooting and Corrective Action

7- Documentation and Record-Keeping

8- Participation in External Quality Assurance Programs

-- EQA involves the participation of laboratories in proficiency

--It allows laboratories to compare their performance with peers

-- The term external quality assessment (EQA) is used to describe a

-- External quality assurance is crucial in various fields, ensuring

-- Overall, EQA plays a vital role in ensuring that organizations

4- Identifying Improvement Areas

-- It includes document control, personnel training, equipment

-- Quality management systems in laboratories assure the reliability

-- QMS in med labs requires quality in all practices including

3- Compliance with Regulations

4- Reduced Errors and Waste

10- Professional Reputation

Q4:- Fill in the Blanks question.

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