STRATEGIES OF ASSURING QUALITY OF LABORATORY

RESULTS

CHEMICAL PATHOLOGY LABORATORY METHODS

(SEMINAR)

By

Godwin Joseph EMEKA

1

OUTLINE:1. Introduction

2. Laboratory Results

3. The Medical Laboratory

4. History of Quality in the Laboratory

5. Quality Management Agencies

6. Quality Assurance Awareness

7. Quality Management Guidelines

8. Quality Assurance

9. Principles of Quality Assurance

10. Components of Quality Assurance

11. Strategies of Assuring Quality of Lab. Results

12. Conclusion

2

INTRODUCTION

•Laboratory tests are medical procedures that

involve analysing samples of blood, urine, tissues or

other body substances. Example of tests ordered for

include: glucose tolerance test, pregnancy test, viral

test, allergy test etc (FDA, 2009).

•A medical laboratory or clinical laboratory is a

laboratory where tests are done on clinical specimens

in order to get information about the health of a

patient

(Farr & Shatkin, 2004).

3

LABORATORY RESULTS

•Laboratory results are products of tests ordered

by a physician as part of a routine check-up, or to

confirm and monitor the health of a patient.

Laboratory results are also used to:

identify changes in patient’s health condition

diagnose a disease

plan treatment for a disease or health condition

evaluate response to treatment

prevention strategies in the absence of disease

(FDA, 2009)4

THE MEDICAL LABORATORY

• Medical laboratories play

important roles in ensuring good

quality healthcare and safety of

patients, hence the need to

ensure and assure the quality of

test it performs and the result it

produces.

• Laboratories are of two types:

i. the hospital lab.

ii. the private (or community) lab.

(Dobrijević, 2013)

5

HISTORY OF QUALITY IN THE

LABORATORY

• The principle of quality management dates back more than 60 years ago. It became prominent in the days of Walter A. Shewhart and Edwards W. Deming i.e. in the 1920’s and 1930’s.

• Quality Management had been an international initiative from the early era of industrialization and has been documented to be a valuable tool in military, government, industries and later in the laboratory.

• In 1947, the International Organization for Standardization (ISO) was created to adopt and enforce industrial standards.

(Noble, 2005).6

HISTORY OF QUALITY IN THE

LABORATORY (contd.)

• With the emergence of numerous health organizations and

agencies, efforts had been focused on harmonizing

laboratory requirements on quality assurance.

• As a result, the formation of the IUPAC/ISO/AOAC working

party in 1978 for harmonization of Quality Assurance

schemes was put in place in achieving this.

• The IUPAC Interdivisional Working Party for Harmonization

of Quality Assurance (WPHQA) opened the door for single-

laboratory method validation, also known as “in-house

method validation”.

(Fajgelj, 2007).7

QUALITY MANAGEMENT

AGENCIES

• Other quality accrediting bodies with similar function as the ISO include:

i. ILAC: International Laboratory Accreditation Cooperationii. CLSI (formerly NCCLS): Clinical and Laboratory Standards

Instituteiii. IQLM: Institute for Quality in Laboratory Medicineiv. ISQH: International Society for Quality in Healthcarev. NCMLQS: National Committee for Medical Laboratory

Quality Systemsvi. IM: Institute of Medicinevii.AHRQ: Agency for Healthcare Research and Qualityviii.IUPAC: International Union of Pure and Applied Chemistryix. JCAHO: Joint Committee on Accreditation of Healthcarex. WHO: World Health Organisation8

QUALITY MANAGEMENT

AGENCIES (contd.)

xi. IHI: Institute for Healthcare Improvement xii. AOAC: Association of Official Analytical Chemist

Organizationsxiii.CCHSA: Canadian Council for Healthcare Services

Accreditationxiv.CDC-DLS: Centers for Disease Control (Division of

Laboratory Systems.) ( Noble, 2005).

Laboratories have always depended on the guidance of the above mentioned health organizations for assistance in laboratory management procedures and accreditation programmes (Wilson, 2008).9

QUALITY ASSURANCE

AWARENESS

• The Quality and Compliance Department of

these organisations assists clients (i.e. laboratories)

with the development of their own quality process,

primarily through lectures, workshops, inspections

and telephone consultation. It also assists clients

with accreditation and licensure.

•Over the years, with the sensitisation and

enforcements carried out by these regulatory

bodies, laboratories now know and understand that

the quality of the laboratory result is directly related

to the quality and reliability of the equipment and

reagents used (Noble, 2005).

10

QUALITY MANAGEMENT

GUIDELINES

The afore mentioned health organizations formulate guidelines and regulations from time to time to meet the expectations and challenges encountered in the laboratory.

Of prominence among these regulations are:

CLSI:GP26-A2 - Application of a Quality System Model for Laboratory

Services; Approved Guideline—Second Edition.

HS01-A - A Quality System Model for Health Care; Approved

Guideline.

ISO:ISO 17025:1999 - General Requirements for the Competence of

Testing and Calibration Laboratories.

ISO 9001:2000 - Quality Management.

ISO 15189:2003 - Medical laboratories -- Particular Requirements

for Quality and Competence.

(Noble, 2005)

11

QUALITY MANAGEMENT

GUIDELINES (contd.)

• ISO guidelines contain15 management requirements and 10 technical requirements. These requirements outline what a laboratory must do to become accredited.

• The ISO 17025 is an international standard that specifies the general requirements for the competence to carry out tests and or calibrations (Middlebrook, 2006).

• The ISO developed and promulgated the ISO 9000 standards. It is a set of four standards (i.e. ISO 9001-9004) enacted to ensure quality management and quality assurance in manufacturing and service

12

QUALITY OF LABORATORY

RESULTS

• The International Standards Organisation defines

“quality” as the degree to which a set of inherent

characteristics fulfils requirements (ISO 9000:2000).

• The quality of a laboratory result is determined by

the protocols and standards put in place by the

laboratory management or healthcare system.

• These standards involve procedures, specifications

and technical recommendations utilized by the

laboratory to achieve her goal and objectives. Usually,

they are documented in form of a manual called the

quality manual.13

ASSURING QUALITY OF

LABORATORY RESULTS

The strategies of

achieving quality of

laboratory results

involves the

implementation of

Quality Assurance

procedures that ensure

that accuracy and

precision of laboratory

results are met.

14

WHAT IS QUALITY

ASSURANCE?

•Quality Assurance (QA) is defined as the sum total

of the activities aimed at achieving a required

standard (ISO, 1994).

•It is a management method that is defined as “all

those planned and systematic actions needed to

provide adequate confidence that a product, service

or result will satisfy given requirements for quality and

be fit for use (Storey et al., 2000).

•Quality Assurance is also defined as a way of

preventing mistakes or avoiding problems and

defects when delivering products or rendering

15

LABORATORY QUALITY

ASSURANCE

Laboratory Quality Assurance encompasses a range of

activities that enable laboratories to achieve and maintain high

levels of accuracy and proficiency despite changes in test

methods and the volume of specimens tested.

QA describes the overall measures that a laboratory uses to

ensure the quality of its operations.

It summarily involves:

systematic measurement,

monitoring of processes,

comparison with a standard,

an associated feedback mechanism that confers error

prevention (MMCF).

16

PRINCIPLES OF QUALITY

ASSURANCE IN THE

LABORATORY

The principles of QA have been formalised in a

number of published protocols or standards. Those

most widely recognised and used in chemical

analysis fall into three groups and are applied

according to a laboratory's individual needs.

The three groups are:

a) ISO/IEC 17025:1999: (RefB1) This standard

addresses the technical competence of laboratories

to carry out specific tests and calibrations and is

used by laboratory accreditation bodies world-wide

as the core requirements for the accreditation of

laboratories;

17

PRINCIPLES OF QUALITY

ASSURANCE IN THE LABORATORY

contd.

b) ISO 9001:2000: (Ref B2) and its national and

international equivalents. This standard relates

primarily to quality management, for facilities

carrying out production, or providing services,

including chemical analysis;

c) OECD Principles of Good Laboratory Practice

(GLP): 1998 (Ref B3) and its national and sectorial

equivalents. These guidelines are concerned with the

organisational processes and conditions under which

laboratory studies related to certain regulatory work

are carried out. 18

QUALITIES OF A GOOD QUALITY

ASSURANCE SYSTEM

A good QA system does these four things:

a) establishes standard operating procedures (SOPs) for

each step of the laboratory testing process, ranging from

specimen handling to instrument performance validation;

b) defines administrative requirements, such as mandatory

recordkeeping, data evaluation, and internal audits to monitor

adherence to SOPs;

c) specifies corrective actions, documentation, and the

persons responsible for carrying out corrective actions when

problems are identified;

d) sustains high-quality employee performance

(CDC, 2014).

19

QUALITY ASSURANCE

SYSTEM

• There is no single method for establishing a QA

system. Each organisation has its own problems that

will require special consideration and planning.

• Once the decision to implement a QA system has

been taken and the necessary funds and facilities

have been made available, then a plan must be

drawn up.

• It is better to build on procedures already in place

and only to remove them if they are clearly

unsatisfactory.

(Storey et al., 2000).

20

QUALITY MANUAL

• The quality manual (also called quality

assurance plan) is a management

document needed to implement QA

programmes (ISO, 1990).

• It is a document that outlines the goals

to be achieved in the laboratory, with

regard to quality of tests and results, and

the quality assurance procedures that

would be put in place to achieve it.

(Storey et al., 2000)21

QUALITY MANUAL (contd.)

A typical quality manual contains the following items:

1) A quality policy statement, including objectives and

commitments.

2) The organisation and management structure of the project,

its place in any parent organisation and relevant organisational

charts.

3) The relationship between management, technical

operations, support services and the quality system.

4) Procedures for control and maintenance of documentation.

5) Job descriptions for key staff and reference to the job

descriptions of other staff.

6) Identification of approved signatories.

7) The laboratory's scope for calibrations and tests. 22

QUALITY MANUAL (contd.)

8) Procedures for ensuring traceability of all paperwork, data

and reports.

9) Procedures for protecting confidentiality and property

rights.

10) Procedures for audit and review.

11) Arrangements for ensuring that all new projects are

reviewed to ensure that there are adequate resources to

manage them properly.

12) Reference to the calibration, verification and testing

procedures used.

13) Procedures for handling calibration and test items.

14) Reference to the major equipment and reference

measurement standards used.23

QUALITY MANUAL (contd.)

15) Reference to procedures for calibration, verification and

maintenance of equipment.

16) Reference to verification practices including inter-

laboratory comparisons, proficiency testing programmes, use

of reference materials and internal quality control schemes.

17) Procedures to be followed for feedback and corrective

actions whenever testing discrepancies or departure from

documented procedures are detected.

18) Procedures to be followed for feedback and corrective

actions whenever testing discrepancies or departure from

documented procedures are detected.

19) Complaints procedure.

(Storey et al., 2000)24

QUALITY MANUAL (contd.)

Moreover, the QA plan must

be seen to be practical and

realistic and not to include

trivial or unnecessarily time-

consuming or difficult tasks.

(WHO/UNEP/VKI, 1997).

It is expected that

laboratories that prepare a

QA plan will produce a plan

that will cover all their

operations.

25

COMPONENTS OF QUALITY

ASSURANCE

• The components of quality management system according to

World Health Organisation (WHO, 2014) include:

i. Documentation

ii. Standard Operating Procedures (SOP's)

iii. Quality Control

iv. External Quality Assessment Scheme

• However, the components of laboratory QA can be summarily

categorized into two components, namely:

i. laboratory quality control

ii. quality assessment (Hoskins, 2009)

26

LABORATORY QUALITY

CONTROL• Laboratory Quality Control is a measure of

precision, or how well the measurement system

reproduces the same result over time and under

varying operating conditions.

• Quality control is designed to detect, reduce, and

correct deficiencies in a laboratory's internal

analytical process prior to the release of patient

results.• The operational techniques and activities that are

used in quality control ensure the fulfilment of the

requirements for quality laboratory results with

emphasis on accuracy and precision.

(Tietz, 2008) 27

QUALITY CONTROL

PROCEDURES

• Quality control procedures

include:

analysis of reference

materials/measurement

standardisation

validation of test methods

analysis of blind samples

use of quality control

samples & control charts

analysis of blanks

analysis of spiked samples

analysis in duplicate

proficiency testing 28

(CITAC & EURACHEM, 2000).

TYPES OF QUALITY CONTROL

• Quality Control consists of two elements:

a). internal quality control (IQC)

b). external quality control (EQC).

• Internal quality control consists of the operational

techniques used by the laboratory staff for

continuous assessment of the quality of the results of

individual analytical procedures.

• External quality control or inter-laboratory control

is

carried out periodically and checked by the

laboratory responsible for the monitoring system.

29

CONTROL CHARTS

• The control chart is one of the seven basic tools of quality

control which include the histogram, pareto chart, check sheet,

cause and effect diagram, flowchart and scatter diagram.

• Control charts prevents unnecessary process adjustments. It

provides diagnostic information as well as information about

process capability. The control chart is a proven technique for

improving productivity.

• Levey-Jennings chart is a graph that quality control data

is plotted on to give a visual indication whether a laboratory

test is working well. The distance from the mean is

measured in standard deviations (SD).

(Tietz, 2008)30

Levey-Jennings Control Chart

31

(Tietz,

2008)Fig.1.1

Control chart

32

Fig.1.2

CONTROL CHARTS (contd.)

• The Westgard rule can be applied to see whether the

results from the samples when the control was done can be

released, or if they need to be rerun. It is programmed into

automated analyzers to determine when an analytical run

should be rejected.

•Westgard rules are commonly used to analyse data in

Shewhart control charts. They are used to define specific

performance limits for a particular assay and can be used to

detect both random and systematic errors.

(Tietz, 2008)

• The Shewhart chart or Process-behaviour chart is a

statistical tool intended to assess the nature of variation in a

process and to facilitate forecasting and management.

33

Westgard Control Chart

34 (Tietz, 2008)

1.3

LABORATORY QUALITY

ASSESSMENT

• Quality assessment or Quality audit

is comprised of those processes

undertaken to monitor and document

the effectiveness of the quality control

program (Hoskins, 2009).

• Moreover, quality assurance

assessment provides a joint

improvement opportunity for

laboratories and its clients.

•The report contains documentations of

laboratory procedure variance and

challenges, inappropriate submissions,

sample handling, achievements, among

other issues (CITAC & EURACHEM,

2000).

35

LABORATORY

STANDARDIZATION

• Laboratory Standardization (LS) involve programs put in

place to improve laboratory measurements. LS is achieved

when test results with the same high level of accuracy and

precision can be reproduced over time across various

measurement systems.

It is dependent on:

reference material

a reference measurement procedure (RMP)—the "gold

standard" measurement system for a particular analyte

secondary measurement procedures

(CDC, 2014)

36

METHOD VALIDATION

• Validation entails checks needed to be carried out to ensure

that the performance characteristics of a method are scientifically

sound and well understood (CITAC/EURACHEM, 2000).

• The time interval required to validate a new, commercially

available laboratory test is substantially between 3 to 6 months

(Wilson, 2008).

• After a method has been validated, found to be suitable and

introduced into routine use in the laboratory, it is necessary to

ensure that it continues to produce satisfactory results. Validity

checks should be made on every laboratory device at frequent or

regular intervals (Storey et al., 2000).

• More on the concept of validation is found in the ISO 9000 and

WHO, BS/95.193.

37

PROFICIENCY TEST

• Proficiency testing is a means of assessing the ability of

laboratories to competently perform specific tests and

measurements. It is an important means of monitoring quality.

• One of the best ways for an analytical laboratory to monitor its

performance against its own requirements and the norm of other

laboratories, is to participate regularly in proficiency testing

schemes.

• Proficiency testing helps to highlight repeatability and

reproducibility performance of a laboratory.

(CITAC/EURACHEM, 2000). 38

CALIBRATION

Calibration is a comparison between measurement devices

i.e. one of known magnitude or correctness

(standard/reference material) and another made in a similar

way (test instrument or unit under test).

Regular internal and external calibration checks must be

performed on equipment such as balances, pipettes, pH

meters etc.

Calibration and maintenance records should be kept for all

equipment, thus allowing the repair status to be monitored

(Storey et al., 2000). 39

STRATEGIES OF ASSURING

QUALITY LABORATORY

RESULTS

Laboratory results can be of reliable quality with the

implementation of all procedures involving quality

assurance.40

STRATEGIES OF ASSURING

QUALITY LABORATORY

RESULTS (contd.)

Moreover, the strategies of assuring quality of

laboratory results can be conveniently grouped with

regard to the three phases of laboratory practice i.e.

the pre-analytical, analytical and post-analytical.

Hence, we have the:

i. Pre-analytical strategies

ii. Analytical strategies

iii. Post-analytical strategies of assuring quality of

laboratory results.

41

STRATEGIES OF ASSURING

QUALITY LABORATORY

RESULTS

42

STRATEGIES OF ASSURING

QUALITY LABORATORY RESULTS

contd.PRE-ANALYTIC STRATEGIES:

i. traceability of results (relating the control result with a

standard).

ii. instituting an associated feedback network that confers error

identification and prevention,

iii. availability of a quality system i.e. a quality testing laboratory

that carry out test to internationally recognised laboratory QC

standards (i.e. ASTM, ISO etc.)

iv. employing educated, trained and skilled staff,

v. adequate training procedures for staff and patients,

vi. correct registration and data input,

vii.appropriateness of samples,

viii.correct labelling of samples,

ix. good transport conditions,

x. compliance with policy and procedure. (Plebani, 2012)43

STRATEGIES OF ASSURING

QUALITY LABORATORY

RESULTS contd.

ANALYTIC STRATEGIES:

i. traceability of results (relating the control result with a

standard).

ii. proficiency testing

iii. use of equipments that are suitably maintained and

calibrated

iv. operating with validated laboratory methods

v. assay precision and accuracy

vi. analytical sensitivity

vii.analytical specificity

viii.diagnostic sensitivity

ix. diagnostic specificity

x. turnaround time

(CITAC/EURACHEM, 2000).

44

STRATEGIES OF ASSURING

QUALITY LABORATORY

RESULTS contd.

POST-ANALYTIC STRATEGIES:

i. dispatching lab. results to their rightful owners

ii. application of corrective actions in the event of errors or

mistakes

iii. comprehensive record keeping

iv. effective documentation and reporting procedures

v. unbiased and efficient client complaints service

vi. efficient internal audit and review procedures

vii.accuracy and clarity of laboratory reports

viii.client interaction and consultation

(CITAC/EURACHEM, 2000 ; Wilson,

2008) 45

STRATEGIES OF ASSURING QUALITY

LABORATORY RESULTS contd.

Other strategies of assuring analytical quality laboratory results

include:

1. the ability of the lab. to be up to date with current updates

on clinical laboratory practice

2. meeting up with accreditation and regulatory requirements

3. identifying malfunctions or deterioration of instruments or its

compartments and replacing them.

4. keeping the lab. environment safe and suitable for

meaningful analysis.

5. proper sample receipt and storage

6. use of duplicate analysis

7. the care and cleaning of equipment.

8. maintaining laboratory equipments on a regular basis as

documented in the relevant standard of procedures (SOP),

codes of practice and manufacturer's guidelines.

46

STRATEGIES OF ASSURING

QUALITY OF LABORATORY

RESULTS contd.

47

STRATEGIES OF ASSURING

QUALITY OF LABORATORY

RESULTS contd.

48

LABORATORY INFORMATICS

•Laboratories today are connected by

a system of software programs and

computers that exchange data about

patients, test requests, and test

results known as Laboratory

Information System (LIS).

•This system enables hospitals and

laboratories to order the correct test

requests for each patient, keep track

of individual patient or specimen

histories, and help guarantee a better

quality of results.

(Dobrijević, 2013).

49

Summary

•Quality management is not static, therefore quality

improvement is expected of every laboratory as required by

the College of American Pathologists (CAP).

• Medical laboratories play important roles in ensuring quality of

care and patient safety. Much of this role relate to the timely

reporting of accurate test results, which depends on the

practice of effective QA.

• There is no compelling reason to deviate from practicing

quality management in the laboratory, particularly because test

results that would be generated without QA are likely to be

clinically irrelevant, misleading, or even dangerous to patients

(Wilson, 2008).

50

Summary (contd.)

• To achieve and maintain high operational standards

through quality assurance, there is the need to address

the quality of sample assayed from the pre-analytical to

post-analytical phases of laboratory analysis.

• It has been reported that the ability of a laboratory to

meet up with accreditation and regulatory requirements

help to determine the quality of results produced.

• However, accreditation alone does not guarantee

high quality testing or results

(Wilson, 2008).51

CONCLUSION

• To assure quality of laboratory results, there must

be an effective and efficient quality assurance

management system put in place in the laboratory.

• Staff competency, training and motivation should

be given adequate attention right from the top

management to the least worker. It is important to

remember – as in the words of Dr. Mabel Charles-

Davies (personal contact): “In the laboratory, even

the so called ordinary cleaner is very relevant to the

accuracy of your analysis”.

52

References

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493; pg1-10.

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Monitoring Bathing Waters ; A Practical Guide to the Design and

Implementation of Assessments and Monitoring Programmes . Chapter 4.

(World Health Organisation, Geneva).

4. Ken Middlebrook (2006): A Discussion Of Proficiency Testing Benefits And

Program Strategies. Canadian Association for Environmental Analytical

Laboratories (CAEAL); Pg 1-8.

5. CITAC / EURACHEM GUIDE (2000): Guide to Quality in Analytical

Chemistry- An Aid to Accreditation. [CITAC www.citac.ws and EURACHEM

www.eurachem.org] Pg 1-58.

53

References

6. Ales Fajgelj (2007): Assuring Quality of Analytical Measurement Results - The

IUPAC Role.

Chemistry International Vol. 29 No. 3.

7. www.iupac.org/publications/

8. Michael L. Wilson (2008): Assuring the Quality of Clinical Microbiology Test

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accessed on 31st March, 2014).

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2014)

12. USA Food and Drug Administration - FDA (2009):Laboratory Tests. www.

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References

13. www.wikipedia.org/ Laboratory Quality Control /: Laboratory Quality Control

(accessed March, 2014).

14. Tietz Fundamentals of Clinical Chemistry (2008): 6th Edition. Sauders Elsevier

Inc. ISBN: 9780721638652. pg 235-261.

15. Mario Plebani (2012): Quality Indicators to Detect Pre-Analytical Errors in

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Recommended Soil Testing Procedures for the North-Eastern United States .

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