Quality System in Laboratories

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Questions and Answers

What is the main objective of a laboratory?

To acquire the latest lab technology

To provide accurate test results (correct)

To ensure all laboratory staff are well-trained

To provide various treatment programs

Which of the following best describes the relationship between internal Q.C and external Q.C?

External Q.C guarantees successful internal Q.C.

Internal Q.C is more important than external Q.C.

They are complementary and should both be present. (correct)

They are independent and do not affect each other.

Who is primarily responsible for internal Q.C in a laboratory?

The laboratory manager

The lab technicians conducting the tests

A supervisor (doctor) monitoring the lab (correct)

A committee of external experts

What does the achievement of a quality certificate indicate?

The lab has reached a degree of excellence. Signup and view all the answers

When does external Q.C typically occur?

From time to time, as part of long-term evaluation Signup and view all the answers

What does Quality Assurance (Q.A) encompass?

Planned activities for confidence in correct results Signup and view all the answers

What is the primary purpose of Quality Control (Q.C)?

To verify that quality requirements are met during assays Signup and view all the answers

Which factor is NOT included in the internal Q.C process?

External inspections Signup and view all the answers

Which factor is NOT associated with pre-analytical control variables at the patient level?

Sample preservation Signup and view all the answers

What is critical for ensuring the integrity of a specimen during transportation?

Maintaining appropriate temperature Signup and view all the answers

Which of the following is NOT a responsibility of personnel in controlling analytical variables?

Sample preservation methods Signup and view all the answers

What aspect of analytical methods involves the evaluation and implementation of reliable processes?

Selection of location Signup and view all the answers

Which attribute of reagents is essential for maintaining analytical reliability?

Stability and efficiency Signup and view all the answers

What is primarily involved in the post-analytical process to ensure the accuracy of test results?

Right interpretation Signup and view all the answers

Which procedure is essential for maintaining the laboratory environment post-analysis?

Surface decontamination Signup and view all the answers

In the event of a reporting error in test results, what action should be taken?

Issue a new report and keep the old one in the patient file Signup and view all the answers

Study Notes

Quality System (A Degree of Excellence)

A laboratory's primary goal is accurate test results
Achieving accuracy requires continuous monitoring and evaluation of lab performance
Implementing and following up corrective actions is crucial
Establishing a robust testing system is vital for successful lab services and treatment programs
Applying a quality system necessitates correct patient data and appropriate reagents for tests
Obtaining a quality certificate signifies achieving excellence, implying perfect results (100%)

Quality Procedures

Quality procedures include internal QC and external QC
These two aspects are complementary and essential for achieving quality assurance (QA)

Internal QC

Internal QC depends on a supervisor (doctor) monitoring lab activities
Key components of internal QC include: patient information, samples, instrumentation, documentation control (computerized data), reagent control, and corrective actions
This process should occur daily

External QC

External QC relies on a committee visiting the lab to issue a quality certificate
This ensures the lab meets external standards
External QC is performed periodically (long-term)
External Quality Assessment (EQA) results evaluate lab performance against other participating labs in the same program
EQA results should be documented and accessible upon request

Quality Assurance (QA)

QA encompasses all planned and systematic activities to guarantee test results are accurate
QA aims to verify the right test is conducted on the correct specimen and the correct interpretation is provided to the correct person
The purpose of QA is maintaining the overall quality of patient results
Pre-analytical, analytical, and post-analytical factors contribute to test results

Control of Pre-analytical Variables

At the level of the patient: Correct patient preparation, proper identification, accurate specimen documentation, and appropriate test selection
At the specimen level: Suitable, clean containers, proper anti-coagulants, crucial transportation procedures (considering temperature), appropriate sample preservation (refrigeration or freezing), correct sample separation, and turnaround time (TAT)

Control of Analytical Variables

Reliable analytical methods stem from careful selection, evaluation, implementation, maintenance, and control within the laboratory

Factors Influencing Analytical Variables

Skilled personnel (education, training, competence, adequate number, supervision, and motivation)
Stable and effective reagents (efficiency, desired quality, continuous availability, cost-effectiveness)
Reliable equipment meeting technical needs (compatibility, validated, user-friendly, cost-effectiveness, maintenance-friendliness)
Specific and sensitive tests (sensitivity, specificity, cost-effectiveness, interpretability)
Accurate documentation encompassing policies, plans, procedures, instructions, and records along with QC procedures
Use of Internal and External controls (national and international)

Control of Post-analytical Variables

Correct recording and reporting of results
Accurate interpretation of results
Results reported to the correct person

Reporting Results

All data entry must be verified by a supervisor and reviewed by management for accurate interpretation and release
If a report needs correction, a new report with updated results is issued
The previous report is kept in the patient file

House Keeping

Surface decontamination (sterilization) of instruments and benchtops
Waste disposal
Cleaning with detergents
Monitoring of fridge, freezer, and incubator temperatures

Objective of Quality in Lab

Reduce morbidity (illness)
Reduce mortality (death)
Reduce economic losses
Ensure lab credibility
Generate confidence in lab results
Implement corrective measures

Consequences of Poor Quality

Inappropriate action (over-treatment, misdiagnosis, excessive investigations)
Inappropriate inaction (omissions, delayed treatment, lack/loss of investigation)
Delayed treatment
Loss of lab credibility
Possible legal actions

Implementing QC Program

Establish a plan for good quality
Assign responsibility for monitoring and review
Ensure adequate reagents, equipment, and personnel training
Establish and implement corrective actions
Collect and maintain data and control data for each patient. Store all data on the computer system

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Description

This quiz explores the crucial aspects of quality systems in laboratory settings, focusing on the importance of accurate test results and continuous performance monitoring. It covers quality procedures, internal and external quality control, and the components necessary for maintaining high standards in lab services. Test your knowledge on achieving excellence through effective quality management!