quality_management in clinical labs

8/12/2019 Quality_Management in Clinical Labs

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Quality Management in clinicallaboratories

Dr.A.S.Kanagasabapathy( Formerly Prof.& Head of Clinical Biochemistry

CMC Vellore)Member of Clinical Chemistry Trainee Council Advisory Board AACC (USA)

[email protected]


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What is Quality?

Quality is doing the right thingsand doing those things right

Philip Crosby (1970)


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What is Quality in the lab?

Establishing conditions suchthat the quality of all testsperformed in the medical labassists clinicians in practicing

good medicine

- Dr. Callum G Fraser


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Organization&

Management

CustomerSatisfaction

ContinualImprovement

Assessment

Technical

Documentation&

Control

Personnel

Facilities

QualityManagement

Standards and Quality Management

MonitorAuditReview

Training andCompetency

Policy

ProcessSOPs

ResponsibilityAuthority

Supply ChainInventoryEquipmentTestingCollectionReporting

Environment and

Safety


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Quality Management System

addresses all process The laboratory environment

Quality Control procedures Communications Record keeping Competent and knowledgeable staff Good quality reagents and equipment


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International Organizationfor Standardization (ISO)

- History

ISO : from the union of two organizations- the ISA (International Federation of the

National Standardizing Associations),

established in New York in 1926- the UNSCC (United Nations Standards

Coordinating Committee), established in 1944


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History of ISOOctober 1946:

Decision to create a new internationalorganization, of which the object wouldbe "to facilitate the internationalcoordination and unification of industrial

standards"The new organization, ISO, officially beganoperations on 23rd February 1947


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Innovator Date CycleWalter A.Shewhart 1920s Statistical Process

ControlW. Edwards Deming 1940s ContinualImprovement

Joseph M. Juran 1950s Quality ToolboxPhilip B. Crosby 1970s Quality by

RequirementRobert W. Galvin 1980s Micro Scale Error

Reduction


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ISO Documents - Laboratory

ISO 9001:2000 Quality ManagementSystem RequirementsModel for QA in design, development production,

installation, and servicingISO/IEC 17025:2005 General requirementsfor the competence of testing and calibration

laboratoriesISO 15189:2012 Quality management in theclinical laboratory


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ISO 15189:2007

The foundation of international

medical laboratory qualitymanagement

Medical laboratoriesParticularrequirements for qualityand competence


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NCCLS / CLSINCCLS : National Committee for Clinical

Laboratory Standards Institute

CLSI: Clinical and Laboratory Standards Institute

Important documents from CLSI:A quality management system model foe laboratory services

Application of a quality management system model forlaboratory services; approved guidelines GP26 -13


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CLSI Quality DocumentsHS1-A2 A Quality Management System Modelfor Health Care

describes quality system model, 12 essentials

aligns to ISO 15189 and parallels ISO 9000applies to all health care systems

GP26-A3 Application of Quality ManagementSystem Model for Laboratory Services

describes laboratory application of quality system modelrelates the path of workflow to the quality system essentials

assists laboratory in improving processesrelates to HS1-A2 and ISO 15189


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QUALITY CONTROL

QUALITY ASSURANCE

QUALITY SYSTEM

QUALITYMANAGEMENT

Stages of Quality - Hierarchy


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QUALITY CONTROL

QC is the study of those errors, which arethe responsibility of the laboratory and ofthe procedures used to recognize andminimize them.

Lab personnel must know that QC is theobligation to the patient : It is designed togive confidence in the methods used andits purpose is not to find scapegoats or topunish mistakes.

The watch word for reliability : Accuracyand Precision


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Quality AssurancePlanned and systematic activities to

provide adequate confidence thatrequirements for quality will be met(ISO)

Includes IQC, EQA, pre-analyticphase, test standardization, post-

analytic phase, management, andorganization (WHO)


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QUALITY ASSURANCE

QA is a comprehensive term thatrefers to all aspects of operationfrom preparation of the patient to

sample collection, sample analysis,recording of the result and itsdispatch.

QA has two components : Internal Quality Control (IQC) External Quality Assessment. (EQA)


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Quality System

Organizational structure, resources,processes and procedures needed to

implement quality management (ISO,NCCLS)


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Quality Management All activities of the overall

management function that determinequality policy objectives, implementthem by means such as qualityplanning, quality control, qualityassurance, and quality improvementwithin the system (NCCLS)


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Quality System Philosophy

Say what you do

Do what you say

Prove it

Quality Assurance


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Quality Assurance

Organizational structure, responsibilities and authoritiesStaff recruitment, training, work allocation, developmentLeadership, motivation and supervisionDocumentation of proceduresTest method selection, development and validationEquipment selection, management and calibrationControl of accommodation and environment

Control of consumable supplies and reference standardsIQC & EQAReception, labeling, processing and storage of samples

Addressing complaints and other corrective actionsRecording and reporting test results

Accounting and administrative functions Audits, Management Review & follow-up improvements

All Activities Associated with the Attainment of Quality


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Closeness of agreement between true valueand the mean of measurement resultsobtained over large number of observations

This can be quantitatively expressed as BIAS Observed value True value

BIAS = ___________________________________ X 100 True valueGood accuracy means least BIAS

ACCURACY

PRECISION


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PRECISION

Closeness with each other of the largenumber of observations in measurementprocess, under prescribed conditions.

This can be quantitatively expressed ascoefficient of variation - % CV

Good precision means least CV


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REPEATABILITY

Closeness of the agreement betweenthe results of successive

measurements of the same specimenwith the following conditions : The same measurement procedure The same analyst The same measurement systems used under the

same conditions The same location


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REPRODUCIBILTY

Closeness of the agreement betweenthe results of successive

measurements of the same specimenwith the following conditions : The same measurement procedure Different analysts Different measuring systems

Different locations and at different times


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Quality assurance covers all

aspects of laboratory tests

1. Pre-analytical

2. Analytical {Internal Quality Control

(IQC) and External Quality Assessment (EQA)}

3. Post-analytical

easons or re ec ng a


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easons or re ec ng asample

Unlabeled samplebroken or leaking tube/container insufficient patient information

sample label and patient name on test requestform do not matchsample collected on wrong container

haemolysed sampleinadequate volume for the quantity ofpreservative

insufficient quantity for test requestedprolonged transport time/poor handling duringtransport


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Method ValidationMethod Validation Precision Accuracy

Range / Analytical MeasurementRange (AMR)

Reference Interval Analytical Sensitivity

Analytical Specificity Interferences

Facilities and Sfety


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Facilities and SfetyDevelop Lab Safety Management Program

Develop a manual for safety and biosafety Organise safety training to staff should include:

universal precaution

infection control chemical and radiation safety PPE

disposal hazardous waste fire extinguishers first aid equipment

Set up process to conduct risk assessment, on- going safety audits towards potential safety

problems

Quality Indicators


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Quality IndicatorsSpecimen Container Information Error Specimen rejection, acceptance IQC (Improvement in % CV of analytes over 12 month period)Proficiency Testing Performance (% of PT values within the allowable criteria, eg. 2 SDI)

Inpatient Laboratory Result Availability (% of test resultsavailable for morning rounds as stipulated in the institution pol icy)Critical Values Reporting Turnaround Time

Clinician Satisfaction With Laboratory Services..Complaints ... (n of complaints received & n of complaints resolved)Telephone calls for results ...

Equipment downtime ...


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Sources of Error

Analytical Random & Systematic

Non-analytical

What are Performance


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Standards?

Performance standards define therequired quality of lab results

The two metrics that define the qualityspecifications:

BIAS (systematic error) % CV (random error)


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TOTAL ERROR ALLOWABLE (TEa)TOTAL ERROR ALLOWABLE (TEa)

If TE present < TEa, patient results areconsidered reliable

If TE present > TEa, the laboratory is

failing to meet quality specifications for thetest & is likely to be producing clinicallyunreliable patient test results

Sigma metric


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Sigma metric

Do you know the Sigma metric for each ofyour test methods? Depends on

- Tolerance limits or quality requirementsfor the test. (TEa)

- Imprecision of the method (SD or CV) - Inaccuracy of the method (Bias)

Sigma metric = (TEa Bias)/ CV


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Westgard RulesSix Commonly Used Westgard Rules

Two - Warning Four - Mandatory

Violation of Warning rules should Trigger A Review OfTest Procedures, Reagent Performance and EquipmentCalibration

Violation of Mandatory Rules should result in Rejection ofthe Results

Warning Rules


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Warning RulesWarning 1 2S - Random Error

Warning 4 1S Systematic Error/ Bias

Mandatory RulesMandatory 1 3S Random Error

Mandatory 2 2S Systematic Error

Mandatory R 4S Random Error

Mandatory 10x Systematic Error


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Thank you