Quality System in Laboratories

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