Quality Assurance in the clinical laboratory

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Quality Assurance in the clinical laboratory




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Presentations text content in Quality Assurance in the clinical laboratory

Slide1

Quality Assurance in the clinical laboratory

Slide2

Why do laboratory errors occur?

Quality

Control &

Assessment

Poor

Workload Management

Understaffed

Non-validatedTests

InadequateAttentionTo Detail

Time Pressures

Poor Results Verification

Poor Sample Control

Monitoring all areas of the work in the laboratory

will decrease errors

Slide3

Definition

Quality

assurance is the coordinate process of providing the best possible service to the patient and physician

Quality assurance includes monitoring and controlling:

The competence of personnel, Quality of materials, Methods, reagents and instruments, and the reliable reporting of test results3

Slide4

Quality assurance

has been defined by WHO as:

The total process whereby the quality of the laboratory reports can be guaranteed.

It has been summarized as:

The Right result, At the

Right time, On the Right specimen, From the Right patient, With the result interpretation based on Correct reference data, and at the Right price.

WHO Definition4

Slide5

1- Sources

of Error

Erroneous results are at best a nuisance; at worst, they have potential for causing considerable harm

Errors can be minimized by:

Careful adherence to robust, agreed protocols at every stage of the testing processThis means a lot more than ensuring that the analysis is performed correctly

Errors can occur at various stages in the process: Pre-analytical, occurring outside the laboratory, Analytical, occurring within the laboratory, Post-analytical, whereby a correct result is generated but is incorrectly recorded in the patient's record,

5

Slide6

6

Slide7

PROCESS

POTENTIAL ERRORS

Test ordering

Inappropriate test

Handwriting not legible

Wrong patients IDSpecial requirements not specified

Specimen acquisitionIncorrect tube or container

Incorrect patient IDInadequate volumeInvalid specimen (hemolysed or diluted)

Collected at wrong time Improper transport conditions

A-

Preanalytical

errors

This includes all the activities performed before the actual work (examination, analysis) is started

Slide8

Analytical Measurement

Instrument not calibrated correctly

Specimens mix – up

Incorrect volume of specimen

Interfering substances present

Instrument precision problem

B- Analytical

errors

PROCESS

POTENTIAL ERRORS

Slide9

Test interpretation

Previous values not available for comparison

Test reporting

Wrong patient ID

Report not legible

Report delayed

Transcription error

C- Post

Analytical errors

PROCESS

POTENTIAL ERRORS

Slide10

2- Aspects

of

a Good Quality Assurance Program

A good quality assurance program has three major aspects:

Preventive activities Assessment Procedures Corrective actions

10

Slide11

A- Preventive Activities

This

helps to prevent error before

it occurs

by:Improving accuracy and precision Method selection Careful laboratory design Hiring of competent personnel Development of comprehensive procedure manuals Effective preventive maintenance programs

11

Slide12

B- Assessment Procedures

Monitor the analytical process

Determine the type of error

Determine the amount of error

Determine the change in accuracy and precisionThese activities include: The testing of quality control material Performing instrument function checks Participating in proficiency testing programs (e.g. survey programs of accrediting agencies)

12

Slide13

C- Corrective Actions

Correct errors after discovery

Communication with the users of laboratory's services

Review of work

Troubleshooting of instrument problems 13

Slide14

3- Quality

Assurance versus Quality Control

Quality assurance is often confused with Quality control

Quality control involves the use of control samples to monitor the precision and accuracy of a test procedure

Control sample is processed along with the patient samples and the results are compared to the expected values and interpreted as acceptable or unacceptableQuality control is an important part of a quality assurance program14

Slide15

A- Accuracy and Precision

Accuracy is the measure of "truth" of a result

Accurate results reflect the "true" or correct measure of an

analyte

or identification of a substance15

Slide16

A- Accuracy and Precision

Precision is the expression of the variability of analysis, reproducibility of a results, or an indication of the amount of random

error

Precision is completely independent of accuracy or

truthA procedure can be precise, as determined by repeat analysis, but the result can be inaccurateThree terms are widely used to describe the precision of a set of replicate data:standard deviation;variance

;coefficient of variation16

Slide17

Good

Accuracy Good Precision

Good Precision Only

Neither

Good

precision

Nor

Accuracy

A- Accuracy and Precision

17

Slide18

Both methods are

equally precise, but in method D the mean value differs from the true

value

The mean for method C is equal to the true

value

Both methods are equally precise, but method C is more

accurate

A- Accuracy

and Precision

18

Slide19

The graph shows the distribution of results for repeated analysis of the same sample by different

methods

The

mean value is the same in each case, but the scatter about the mean is less in method A than in method

B

Method A is, therefore, more

precise

A- Accuracy

and Precision

19

Slide20

B- Types of Errors

When Errors Occur ?

Errors

occur when there is a loss of accuracy and precision

A primary goal of quality assurance is to reduce and detect errors or to obtain the best possible accuracy and precision20

Slide21

B- Types of Errors

Mistakes jeopardize patient care and must be detected and avoided at all

times

An error is the difference between the result obtained and the result expected

Random errorsSystematic errors

21

Slide22

a- Random Errors

Occur

without prediction or

regularity

Affect measurement of precision and causes data to be scattered moreRandom errors occur as the result of:Carelessness, Inattention,

when taking short cuts in procedures, Mislabeling specimens, Incorrect filing of reports, Reporting of wrong result to the wrong

patient22

Slide23

b- Systematic

Errors

Errors within the test system of

methodology

Affect the accuracy of resultsCauses the mean of a data set to differ from the accepted value Examples include:Incorrect instrument calibration

Unprecise or malfunctioning dilutors and pipettes Reagents that lost their activity Quantitative tests being read at an incorrect wavelength

Reagents are not prepared from sufficiently purechemicals

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Slide24

b- Systematic Errors

Types of systematic errors

Proportional

systematic error or bias

It grows larger as the concentration of analyte growsConstant systematic error "constant bias" A constant amount over the entire range of the analysis

processThe magnitude of a constant error does not depend on the size of the quantity measured24

Slide25

b- Systematic Errors

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Slide26

c- Detection of Errors

Analyzing standard samples

The

best way to estimate the bias of an analytical method is by analyzing standard reference materials, materials that contain one or more

analytes at well-known or certified concentration levelsUsing an independent analytical method

The independent method should differ as much as possible from the one under study to minimize the possibility that some common factor in the sample has the same effect on both methodsPerforming blank determinationsVarying the Sample SizeAs the size of a measurement increases, the effect of a constant error decreases. Thus

, constant errors can often be detected by varying the sample size.26

Slide27

4- Benefits

of an Effective quality Assurance Program

Correct and timely presentation of data to the physician

Improvement

of precision and accuracy Early detection of mistakes More efficient and cost effective use of materials and personnel Meeting the requirements of inspection and accreditation agencies Development of accurate and concise procedures and manuals Measure of productivity of personnel and instrumentation.

27

Slide28

Personnel, Staff Development & Quality Assurance

Slide29

1- Introduction

The

most expensive and complex resource in any organization is its'

employees

Choosing the appropriate individuals for the job and managing them effectively is one of the most difficult and powerful means available to prevent errors in the laboratory29

Slide30

1- Responsibility

within a Quality Assurance

Program

There are three tiers of responsibility in a well - designed quality assurance program:

The director, the supervisor, and technologist or technicians These levels exist in all laboratory organizations regardless of sizeA small hospital laboratory may have a director, one supervisor, and handful of technologistsThe director in the laboratory service of a large medical center may have an associate and assistant directors as well as a support staff that works for and reports to

himThe supervisor tiers in a larger organization can be divided into sections such as hematology, chemistry, or microbiology and the technical level can include numerous technologists and technicians30

Slide31

A- The director

His role is to direct and set

policy

He

is responsible for deciding the direction of the laboratory in the near and far futureHe is responsible for defining goals, objectives and performance standardsHe is responsible for communications with other levels concerning what is expected of them and keep them informed about the laboratory’s position in the hospital organizationHe is responsible for communicating to the users of the laboratory's services, capabilities and

limitations31

Slide32

B- The Supervisor

His job is to implement the objectives set forth by the

director

He

should be a competently certified technologist capable of understanding the role of the laboratory in providing health careHis responsibilities include both administrative and technical onesHe must be sure that each member of the technical staff is aware of his responsibilitiesHe should maintain work conditions in which goals are fulfilledHe is responsible for interviews, hiring, evaluation and disciplines the technical

staff32

Slide33

B- The Supervisor

He is the direct connection between the director and the technical

staff

His

communications must be two-way:Downward from director to the technologists, And upward from the technologists to the director.He should be capable of managing an effective quality assurance program to provide the required level of service

33

Slide34

C- The Technical

Staff

They

should be trained how to operate the quality assurance

programThey should be qualified and continue to update their level of competence by participating in continuing education programsThey perform the laboratory workloadThe success of any laboratory quality assurance program depends on the dedication of the technical staff in providing a top - quality level of performance.

34

Slide35

Tiers of Responsibility

35

Slide36

2- Tools of the Trade

There are some personnel management tools that should be part of the quality assurance system:

Intralaboratory

CommunicationOrientation and TradingPersonnel

ManualsPersonnel FilesWorkload Recording

36

Slide37

A-

Intralaboratory

Communication

Communication is an essential part of any

enterpriseLaboratory communication can be improved by memorandums (memos), newsletters, laboratory log

bookMemorandum is used to emphasize policy or information of general interest to the technical staffNewsletters are used for making routine announcements, social events, giving credit for extraordinary work etc..Laboratory logbook is for every one left open, record daily events, serves as a record of the shift- to- shift, day - to - day life in the laboratory

37

Slide38

B- Orientation and

Training

A

Well - informed technical staff is the best defense against serious

errorsThe orientation of new employees to the laboratory's policies and procedures should be a well - planned and well - executed quality assurance activityThe orientation program should be well - structured and carried out within and appropriate time periodFor orientation, a new employee should have a written job description and a training checklist covering the important technical and non technical facets of the job. The completed checklist should be a part of the employee's permanent personnel file

Participation in continuing education programs should be encouraged as there are rapid advances in technology and new discoveries in laboratory medicine38

Slide39

C. Personnel

Manuals

Each

laboratory should have available at all times a copy of the hospital's and laboratory personnel

policiesThese manuals should clearly outline work rules, disciplinary guidelines, sick and holiday benefits, work hours and the method by which compensation is calculatedEach new employee should be required to read the personnel manual during his orientationIf everyone is aware of work rules and employee rights, misunderstanding and unproductive attitudes can be avoided and a better opportunity to work in harmony will exist

39

Slide40

D- Personnel Files

It is the record of the employee’s experience within the laboratory and

should contain the following in a neat

and organized

manner:Job descriptionPayroll information "rate of pay, vacations, sick leave".

Resume "showing qualification, letters of recommendations etc...Periodic performance evaluation recordsReports of any disciplinary actionsDocumentation of continuing education

Training or orientation records, Records of physical examinations, immunizationRecords of radiation exposure

N.B. The personnel files should be treated with confidentiality by supervisor and employee40

Slide41

E- Workload Recording

A tool to document the

time required to perform the laboratory workload

A

unit value has been assigned for each procedure, based on the length of time required to prepare the specimen for analysis, to perform the analysis, and report the resultsIt can be applied for comparison within and between laboratories, it reflects the efficiency of the laboratory in performing its tasks41


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