Clinical Lab Quality Control

Quality Control in Clinical Laboratory Overview

• Quality is the sum-total of all the characteristics of a product or service that impact its utilization and consumer satisfaction
• Quality is invisible when good and impossible to ignore when bad
• Laboratory quality has evolved since the first quality control recommendation in 1965
• Quality control is now one part of a total laboratory control program
• Total Quality Management (TQM) is an activity to improve patient care by monitoring lab work and correcting deficiencies
• Continuous Quality Improvement (CQI) or Performance Improvement (PI) improves patient care by emphasizing mistake prevention
• Quality Assurance (QA) is external activities ensuring positive patient outcomes and measures a lab's reliability

Fundamentals of Quality Management

• Principles of quality management, assurance, and control are foundations for clinical lab management
• Total Quality Management of the clinical laboratory is crucial
• Control of pre-analytical variables is fundamental to quality management
• Control of analytical variables is another aspect of quality management
• External quality assessment and proficiency testing programs are also aspects of quality management

Total Quality Management (TQM)

• TQM includes total quality control (QC), total quality leadership, continuous quality improvement, quality management, and industrial quality management
• Healthcare organization quality systems are evolving
• Public and private sector emphasis on cost containment and quality improvement is increasing
• TQM provides management philosophy for organizational development and a process for quality improvement in all work aspects

Concepts of TQM

• The principles include customer focus, management commitment, training, process capability & control and using quality-improvement measurements
• Costs must be understood in context of quality
• Quality = conformance to requirements
• Quality Costs = costs of conformance + costs of non-conformance
• Improved quality leads to reduced costs

Quality Costs

• Conformance costs include prevention costs such as training, calibration, and maintenance
• Appraisal costs include inspection and quality control
• Nonconformance costs include internal failure costs like scrap, rework, and repeat runs
• External failure costs include complaints, service, and repeat requests

Methodology for Quality Improvement

• Quality improvement happens when problems are eliminated permanently
• Quality problems are primarily management issues because management can change work processes
• The most immediate processes are those of frontline employees
• Senior management must support and empower frontline employees

Implementing TQM

• Quality laboratory processes include the practices and procedures that define how to do the work
• Quality control emphasizes statistical, and non-statistical control measures such as implementing TQM
• Quality assessment concerns broader measures of lab performance such as turnaround time, specimen identification, patient identification, and test utility
• Quality improvement structures a problem-solving process to identify the root cause of a problem and its remedy
• Quality planning provides the planning steps

5-Q Framework

• The five components: Quality planning, Quality lab process, Quality control, Quality assessment and Quality improvement, when working together, illustrate how continuous quality improvement is accomplished in the laboratory process
• Quality is managed objectively within the "scientific method", or PDCA cycle
• QP provides the planning step, QLP establishes standard processes, QC & QA provide measures for checks, and QI provides a mechanism through which to act on those measures

Quality System Basics

• TQM is considered a quality system (QS) ensuring quality
• QS has key quality elements that support an organization's work to meet quality objectives

Quality Systems Objectives

• The main goal is to provide reliable, timely, and precise test results
• This is possible through monitoring and evaluating lab performance
• Implementation and follow-up of corrective actions are also needed for non-conformance to procedure

Reputation & Testing

• Reputation can be damaged by one poor quality result, even with 10,000 good results
• Establishing robust testing systems are essential for successful laboratory services
• Establishing and consistently monitoring quality systems in the lab provides reliable and robust testing

Quality Systems Assurance

• Provide assurance of the quality of test results
• Lab operations should be coordinated, organized, and standardized
• Quality systems are also tools to monitor performance

Quality Control vs Quality Assessment

• Quality Control (Internal) + Quality Assessment (External) = Quality Assurance
• Internal Quality Control (IQC) includes personnel, instrumentation, document control, reagent control, and corrective action
• External Quality Assurance (EQA) helps laboratories know if they are performing to required standards

Quality System Assessment

• Quality can be assessed through man-driven or material-driven methods
• Man-driven assessments include on-site audits both internally and externally, plus accreditation
• Material-driven assessments include Internal and External Quality Assessments
• External Quality Assessment Schemes (EQAS) are a schematic way to conduct external assessments

QC vs QA

• Quality control (QC) uses techniques during each assay to verify quality requirements
• Quality assurance (QA) uses planned activities to ensure correct lab results
• QC aims to ensure the test results are correct
• QA ensures the right test is done on the right specimen, by the right person at the right time

Quality Assurance Factors

• QA maintains the overall quality of patient results
• All factors affect the test results from when the test was ordered
• The QA process includes Pre-analytic, Analytic and Post-analytic phases

Quality Assurance Cycle

• The QA cycle includes Pre-analytic processes. patient/client prep and sample analysis, Sample collection
• Analytic: quality control and competency evaluations
• Post-analytic: reporting and record keeping

Steps for Laboratory Quality Control

• Implementing quality control and documentation in laboratories requires foreseeing potentially adverse effects on patients.
• Quality control can help any lab benefit from confidence in and reproducibility in all test processes that are performed
• Monitoring and documenting test variables such as temperature and reagents allows for retrospective analysis of accuracy and precision
• Quality control is a mutual responsibility shared among laboratory specialists and clinicians

Objectives for Labs

• Support high quality care
• Reduce morbidity and mortality
• Reduce economic loss
• Maintain credibility of the laboratories
• Generate confidence in lab results

Poor Quality Consequences

• Include inappropriate procedures, like over-testing and or over-treatment
• Inappropriate inaction, like lack of treatment
• Delayed action
• Loses credibility of the lab
• Legal implications

QC Implementation

• To implement a strong QC program, create policies and procedures, assign responsibility, train staff, and provide control materials
• Follow through by collecting routine data by setting values and using Levey-Jennings charts
• Routinely assess data to maintain continuous improvement in the lab

Implementation Difficulties

• Difficulties and hurdles within quality control can occur at different times
• These are time of test order, specimen analyzation, and test interpretation and reporting processes
• Be aware of common issues such as illegible handwriting, incorrect tubes, transport conditions, etc

Controlling Pre-Analytical Variables

• Preanalytical variability defined as errors that occur during non-analytical factors that change the concentration of analytes
• Appropriate tests must be requested and performed
• Improper labeling occurs and can be corrected by bar coding
• Turnaround time should be keept at a minimum
• Maintain both laboratory logs and patient records
• Transcription errors pose a risk; computerization reduces errors

Preanalytical Variable Preparation

• Patient prep is key to proper test results
• Specimen collection occurs with timed testing and proper anticoagulant or container use
• Using vacutainer tubes and correct sample collection maintains quality results
• Maintain sample integrity by correctly transporting all samples
• Ensure proper centrifuge protocols to avoid contamination of samples.
• Follow safety protocols at all points

Analytical Variable Influences

• Analytical factor proficiency is maintained through education, training, commitment and supervision
• Equipment reliability measures include functionality of equipment, user friendliness, and proper maintenance
• Use appropriate controls. Calibrations and evaluations on both internal and external equipment
• Documentation ensures well-written plans, procedures, records and control reports in order to maintain a high quality laboratory

Analytical Variable Control

• Properly controlling the variables with calibration guarantees the most precise measurements
• Reliable analytical techniques are reached by following correct selection and evaluation protocols at every stage
• Analytical methods include measurements such as trueness, precision, and linearity, with control over the limits of detection

Calibration

• Calibration is the relation between instrument signal (y) and conc. of analyte (x)
• Calibration functions are set up to establish relations between quantities by realized "measurement standards"
• Calibration function may be graphically expressed linearly or curved as an instrument
• In automated machines, relationships are often stable
• In traditional chromatography (HPLC), calibrating is customary for analytical runs

Trueness

• Trueness is the closeness of agreement between the average value from measurements and a true value
• True value is known or accepted
• Bias determines the true value to the value measured
• Measurable value is quantifiable through individual measurements

Accuracy

• This is the closeness of agreement between the result of a measurement from the true concentration of the analyte

Precision

• Precision is the agreement between results under stipulated conditions
• Replication determines measures of dispersion
• Measurements: inter-assay runs and intra-assay different days

Precision Measurements

• Repeatability occurs within the same run
• Reproducibility or closeness of performed results during variable measurements
• Standard Deviation (SD), measurement occurs as a variation (CV)
• Measurements are performed as a statistic to determine the Standard Deviation

Reliability

• The ability to maintain consistency, precision, and accuracy

Linearity Principles

• Refers to the relationship between measured and expected values
• Can be considered with the analyte evaluation.
• Evaluated by plotting & test regression
• Related to assessment of trueness, with a prerequisite of a high level of trueness

Detection & Quantification

• LoB: likely highest measurement result for a blank sample
• LoD: lowest measurement can be consistently detected in 95% samples in the right conditions
• LoQ: reliable amount in the laboratory setting, b/n relationship, LoB, LoD, and LoQ

Imprecision Causes

• Multiple instruments
• Pipettes that lack precision
• Sporadic maintenance
• Different Lots of Reagents lot-to-lot evaluation
• Differences in staff and competencies

Equipment Guidelines

• All laboratory equipment should come with user and operation manuals
• Monitor and record procedures to follow standards
• Document all processes

Procedures to Put Equipment Into Use

• There are processes to accomplish through correlation/agreement studies
• Have new equipment, method validated through old equipment, methods
• Maintain daily temperatures and record serials

Instrument Maintenance Essentials

• Calibrators & controls from manufacturers
• Follow a scheduled plan: both daily and week
• Make sure a technician documents any instrument servicing

QC Procedures on Pipettes

• Pipettes must be checked and calibrated, check with manufacturer for help and repair if needed
• Improper Pipettes affect and require checks, with the right precision, send to vendors for assistance

PIPETTES Impact of QC

• Clean pipettes after being analyzed and send out for parts or service from reliable vendors
• Track everything such as calibration, function check, and including every identifying number, and service records

Lab Reagents

• Storage requirements: Store according to the manufacture instructions
• Date and Initial
• Label all the things after preparation
• Label everything and follow manufactures requirements

Reagent testing

• Must be checked against each other against controls, with new and used materials
• Report must have date and variability results

Personnel

• Restrict certain material to those with sufficient training
• Perform test
• Maintain and document standards

Personnel Standards

• Require personnel involvement
• Require qualified personnel
• Maintain ongoing education
• Maintain all data and document them

Documentation

• If you don’t document it, you haven’t done it
• If its not documented, its hearsay

Documentation Value

• Documentation is traceable
• Assure the process is auditable
• Maintain training capabilities and standard

Documentation Essentials

• Archives for results of tests in accessible manner
• Recording of temperature, and any corrective actions
• SOPs maintained and up to date to make sure that everyone in the lab is following correct practice

CLSI Standard

• Intent, Title of documents
• Purpose of the experiment and goals to experiment, reference outside and auxiliary functions of the laboratory

Validation

• Is about knowing to know if its doing what its meant to do

Quality Influences

• Validity must be upheld before anything is introduced

Validate and Revalidate

• Re- evaluating after after change or adjustment
• Reference all that and documentation

Post-Analytical Quality Factors

• Include both correct recording and a high standard of range interpretation
• Maintaining turnaround and providing reports to the user

Reporting

• Have section head supervisors that are reviewing the reports as well
• Be aware and include any reports that have to be corrected to the patients
• Document the time and all records that are included in a report

Housekeeping

• Tidy workspace, follow guidelines and procedure

Controlling Statistical Methods

• Statistical data
• Follow standard

Deviation and Distribution

• That indicate if distribution is effective and efficient

Index

• Standard Index
• The values the the peer groups

Reagents

• Have to be controlled and in the right condition
• There also testing for the aliquot, and that test are done with aliquot tests

Quality Control Matrix

• Test samples or controls
• Has matrix, and follows the same method as a sample

Testing

• The values the the peer groups

Calibrators and Controls

• Set up tests to be completed

Setting Values

• Use a chart and see the values of the control sample and see that it was set up correctly