Quality Assurance and Quality Control

• Quality Assurance (QA) is the development and implementation of measures to assure reliable laboratory service.
• Quality Control (QC) is the ability of a product or service to satisfy the needs of a customer.
• Pre-analytical refers to before testing
• Analytical refers to the testing phase
• Post-analytical refers to after testing
• Clerical Errors are mistakes in writing results
• Sampling errors are mistakes in the specimen that is collected
• Accuracy is the closeness of a result to its true value
• Precision refers to the closeness of replicated results of the same sample to each other
• Total Quality Management (TQM) is a comprehensive, user oriented approach to achieve quality laboratory service.

Quality Assurance (QA)

• QA aims to detect, control, and prevent errors in the laboratory
• It involves the organizational structure, responsibilities, processes, procedures, and resources for implementing quality management
• QA provides accurate, precise, and timely results
• The World Health Organization (WHO) states QA is a total process for ensuring the quality of lab reports
• It ensures the right result, at the right time, from the right specimen, interpreted correctly, and at the right price

Total Quality Management (TQM)

• Achieves reliable lab service, more so than QC alone
• QC is a component of TQM
• It influences how lab services function and how resources are used to provide reliable results
• Technical Aspects of QA include pre-analytical, analytical, and post-analytical phases
• Considers lab users' information, like result turnaround time, professionalism of staff, and trust in data.

Quality

• Quality involves determining customer requirements, ensuring resources are available, and implementing management procedures.
• It ensures quality is the foundation of laboratory work
• It Sets the Standard for quality level
• It Meets/exceeds customer expectations
• It provides means to prevent, detect, and correct problem
• It Becomes the core of a monitoring, evaluation, & improvement system

Essential Components of a Quality System

• The components include various elements
• Organization
• Personnel
• Equipment
• Purchasing & Inventory
• Process Control
• Information Management
• Documents & Records
• Occurrence Management
• Assessment
• Process Improvement
• Customer Service
• Facilities & Safety

Quality System Organization

• Include quality policy and standards, sufficient resources, clearly defined roles & accountability, as well as a culture committed to quality
• Involves creating a quality program and defining authority and responsibility for staff.
• Allocate sufficient resources to maintain quality requirements
• It must establish working environment

Quality System Personnel

• It involves human resource planning, hiring, training, supervision, retention and performance management.
• Job descriptions should be developed to ensure compliance and that staff are achieving job descriptions

Quality System Equipment

• Encompasses selection, acquisition, installation, initial calibration, maintenance, service, repair, troubleshooting, and disposition of equipment

Quality system: Documents and Records

• It involves Standardized Forms
• Document Approval Process
• Document Distribution
• Document Storage/Retrieval Methods
• Document Destruction plans

Quality System Purchasing and Inventory

• Encompasses selection, acquisition, installation, initial calibration, maintenance, service, repair, troubleshooting, and disposition of equipment

Quality System Process Control

• Process controls involves all lab operations
• These include method selection, SOPs development, Specimen Management, QC, EQ assessment, Use of an up-to-date information and Technical procedure manuals

Quality System Information Management

• it involves information Flow, Data Collection & Management
• Patient Privacy & Confidentiality as well as Computer Skills

Quality System Occurrence Management

• It is the use of Written Procedures for Addressing Errors
• It includes Corrective Actions
• It is made up of Occurrence Records and Occurrence Reporting

Quality System Assessment

• It involves three processes
• External Quality Assessment
• Improvement Measures
• Internal Audit or Self Evaluation

Quality System Process Improvement

• Includes on-going data collection and improvement measures

Quality System: Service and Satisfaction

• Includes monitoring of Customer Satisfaction
• Involves Process Improvement
• Incorporates Rewards

Quality System Facilities and Safety

• It involves Testing and Storage Areas, Safety Practice and Safety Procedures & Records

Characteristics and Aspects of QA

• QA is comprehensive, rational, regular and involves frequent action to detect and correct errors.
• The three aspects of QA are Preventive, Assessment, and Corrective
• The Preventive aspect aims to prevent errors by improving accuracy and precision by using proper methods, lab design, staff, SOPs, and maintenance
• The Assessment aspect monitors the analytical process to identify errors, achieved through quality control materials, function checks, and proficiency testing
• The Corrective aspect corrects errors after discovery through communication, work reviews, and troubleshooting

Basic Components of Quality Assurance

• Internal Quality Assessment (IQA)
• External Quality Assessment (EQA)
• Standardization of processes and procedures (pre-analytic, analytic and post-analytic phases)
• Management and Organization

Benefits of QA

• Early detection of errors is made easier
• QA increases efficiency and cost-effectiveness
• It meets requirements for accreditation agencies
• Enables productivity measurement
• Improves precision and accuracy
• Helps physicians, patients and clients
• Creates good reputation
• Motivates staff
• Builds trust

Purpose of Health Laboratory

• Provide patient laboratory results
• Diagnostic purposes
• Prognostic use
• Monitor treatment
• Monitor disease outbreaks

Errors in the Clinical Laboratories

• There are three stages of Analysis - Pre-analytic, Analytic, and Post-analytic
• Errors in each stage should be prevented

Pre-Analytic Errors

• Occur at the phase before testing
• Processes include Test Ordering, Specimen Collection and Specimen Handling

Pre-analytic Specimen Collection Errors

• Wrong patient ID
• Anticoagulant Issues
• Volume Issues
• Haemolysis
• IV contamination
• Prolonged tourniquet

Preventing and Detecting Errors Pre-Testing

• Check storage and room temperature is correct
• Check inventory and expiration dates
• Review testing procedures
• Record pertinent information, and label test device
• Collect appropriate specimen
• Test Ordering includes order, legibility, and potential delays
• Specimen Collection includes meeting patient ID requirements, wrong tube or volume use, poor sample conditions, and inappropriate timing
• Specimen Handling includes incorrect transport conditions

Analytic Errors

• These occur during testing phase errors and can auto-monitoring, error codes and Quality control result rejection signals

Analytical errors are of two types

• Indeterminate (random error)
• Determinate (systematic error)

Indeterminate (random errors)

• Are errors that occur with our prediction or regularity
• Cannot be easily determined
• Is an error which varies in unexpectable manner in magnitude and sign
• It create a characteristic spread of results for any test method and can not be accounted by applying corrections
• It is difficult to eliminate but repetitions may reduce the influence

Indeterminate random errors

• May be caused by uncontrollable fluctuations in temp or the voltage
• It may be caused by small variations in volumetric apparatus or minute difference in the wave length of the measurements
• In addition may occur as a result of carelessness, inattention and short cuts in procedures

Determinate Errors (systematic errors)

• Describes errors which are constantly high or low.
• Constant systematic error: The error is constant regardless of the analyte concentration
• Is an error which occurs in the course of a number of measurements of the same value of a given quantity, remains constant when measurements are made under the same conditions or varies according to a definite law when conditions change

Causes for Constant Systematic Errors

• Caused by an interfering substance in samples or reagents, and leading to the delivery of a false signal with enzymatic methods.
• It can be caused by non chemical source issues like improper blanking of the sample or reagent

Proportional Systematic Errors

• Occur when a sample with more analyte concentration than is labeled on, all the unkownmeasurements are recorded low
• If an error in testing, the slope of the line is different from One, and the Y-intercept should be zero

Preventing and Detecting Errors During Testing

• Perform and review Quality Control (QC)
• Should safety precautions be present
• Conduct tests according to written procedures
• Correctly interpret test results

Post Analytic Errors

Includes clerical errors as well as illegible reports or are sent to the wrong location

• Information System may not be accurate and reference ranges may be be wrong. -Reporting may be delivered in an untimely manner
• Confidentiality may not be maintained
• Correcting Post Analytic Errors: Re-check patient/client identifiers
• Write legibly and Clean up and dispose of contaminated waste
• Any packages, like QA, should be stored for re-testing