24 views

Uploaded by Ega Hida Prabowo

kjk

- FuelInjectorNozzles En
- E2E_sensorproximidad
- Article1431614439_Freitas Et Al
- Method Verification
- Six Sigma Executives Training Main Steps of a Six Sigma Project
- Grade 7 Midterm Exam Revison
- Estatistic.docx
- ia-rivers-2018-checklist
- isd
- Cobb Breeder Guide 2008
- CP CU1 Precise Line
- HorRat CIPAC Athens 2015
- D4435
- Determination of quartz in kaolins by x-ray powder diffractometry
- eng 487 project 2
- psc.pdf
- Richardson
- Climate Extremes
- DFSS1
- Mth507-Mathematics for Social Science (1)

You are on page 1of 38

Abdul Rohman

Fakultas Farmasi UGM

Yogyakarta

1

When evaluating laboratory results, how do we

determine that is normal or acceptable? That is:

What is normal or OK?

When does a laboratory test result become

weird or abnormal ? When do be become

uncomfortable with a result?

Statistics are used to determine the lines of

normal and acceptable.

patient specimens, control specimens and

calibrators

If the results are normal we re comfortable

about them and dont worry

But if theyre abnormal, were uncomfortable and

we fear that there is something wrong with the

patient

or just as bad, something is wrong with the test

procedure .

3

Accuracy*

Control specimen*

Dispersion

Histogram

Precision

Quality Assurance

Quality Control

Random error

Reference method

Shift*

Standard specimen

Trend*

Coefficient of Variation (CV)*

Mean*

Average*

Mode*

Median*

Gaussian Curve*

Pre analytic (error)

Analytical error

Post analytic (error)

Range*

Z - Score

Statistical Concepts

Statistics is a (science of ) branch of mathematics that collects,

analyzes, summarizes and presents information about

observations.

In the clinical lab, these observations are usually numerical test

results

A statistical analysis of lab test data can help us to define normal

ranges for patients ( normal and abnormal ) and acceptable ranges

for control specimens ( in and out of control )

Descriptive statistics information about one group of

observation

Inferential statistics ways to compare different groups of

observations

5

Mean - Average value

Median - Middle observation

Mode - Most frequent observation

Mean

- Average value

T h e s u m o f a ll th e o b s e r v a tio n s

th e n u m b e r o f o b s e r v a tio n s

Median - Middle observation

List all the observations in order of

magnitude and pick

the observation thats in the middle

In a odd # of observations = Middle

observation

In an even # of observations = Average of

the 2 middle values

The observation that occurs most

frequently

There may be more than one mode, or

Graphical presentation

histograms and bar-charts

SD Is a mathematical expression of the

dispersion of a group of data.

SD

n 1

a way of expressing standard deviation

in terms of average value of the

observations used in the calculation

10

Control

Quality Assurance (QA)

Includes pre-analytic, analytic and post analytic

factors (to be discussed)

All systematic actions necessary to provide

adequate confidence that the laboratory services

will satisfy given medical needs for patient care.

In other words: Quality assurance is an all

inclusive / comprehensive system monitoring the

accuracy of test results where all steps before,

during and after the testing process are considered.

11

is the system used in the clinical laboratory to

recognize and minimize the analytic errors.

QC system is to monitor the analytical process;

detect errors during the analysis and prevent

reporting of erroneous test results.

It uses statistical analysis of test system data

12

objectives

Record of precision

Early warning of shifts and trends

Permits a valid judgment on the

accuracy of a measurement

Facilitates comparison of test methods

Monitor equipment performance

Indicates the analytical abilities of a

tech

Accumulate a body of knowledge to

satisfy outside accrediting agencies

13

1. Analysis of control materials such as CRM or

spiked samples to monitor trueness (Accuracy)

2. Replication of analysis to monitor precision

VERIFICATION

www.themegallery.com

Accuracy

expresses the closeness of agreement

between the value which is accepted

(either as a conventional true value or an

accepted reference value ) and the value

found.

This is sometimes termed trueness.

observations are to the true or correct value

Right on target !

Close enough?

Keep your day job

In the laboratory we need to report tests with accuracy and precision, but how

accurate do we need to be? Its not possible to hit the bulls-eye every time.

So how close is close enough?

16

concentration

Precision :

Observations that are reproducible or

repeatable.

If you repeatedly test / assay a sample and

get wide variation in the assayed results,

you have low precision.

18

www.themegallery.com

Precision

3 possible testing outcomes - Hitting the target

x

x

x

x xxx

xx

xxxx

x

21

Classification of Error

***The variables:

Pre-analytical variables,

right specimen from right patient and in right

condition

Analytical variables

all parts of testing procedure performed properly,

controls in range

Correct report to correct person, interpreted correct

subject to errors and must be closely

monitored, to maintain Quality Assurance.

22

Bias

Bias the amount by which an

analysis varies from the correct

result.

Example, If the Expected Value is 50

units, and the result of an analysis is 47,

the bias is 3 units.

23

Classification of error

identify examples of:

Analytical error

Random or indeterminate

Systematic or determinate

Post-analytical error

Misinterpreted, etc.

24

controls in clinical chemistry

Assayed controls:

Un-assayed controls:

Compare cost vs convenience

25

Establishment of a QC system

Collecting data

Run assay on control sample & manually

enter control results on chart

One chart for each analyte and for each

level of control

26

Minimum number of determinations

Statistically should have at least 20

determinations to establish acceptable

mean and practical standard deviation.

27

www.themegallery.com

dispersion in your result compared with the rest of

the results its abnormal

This suggests that something is wrong with the

process that generated that observation

Patient test results cannot be reported to

physicians when there is something wrong with the

testing process that is generating inaccurate

reports

Remember No information is better than wrong

information

29

be investigated

one point outside the action lines

Two successive points outside the same

warning line

eight successive points lying on one specific

side of the target value line

Provision can also be made for stopping a

process in cases where the plotted mean values

show a trend (e.g. six increasing or decreasing

points in succession, even if the points are

within the warning

lines)

www.themegallery.com

do: ie. Corrective methods

Instrumentation malfunction ( fix the

machine)

Reagents deteriorated, contaminated,

improperly prepared or simply used up

(get new reagents)

Tech error (identify error and repeat the

test)

Control specimen is deteriorated or

improperly prepared (get new control)

31

Use of Standard

Deviation

Once you have determined the

standard deviation, must use the

information to evaluate current/

future analysis.

Most labs make use of 2 SD or 95%

confidence limit. To put this into a

workable form, you must establish

the range of the 2 SDs

32

the range of acceptable results

mean of group of control values = 104

mg/dL

Standard Deviation = 5 mg/dL

Determine the Range of 2SD; (which will

allow you to evaluate acceptability of

performance of the control on subsequent

days.)

Is a control value of 100 mg/dL

acceptable?

33

Z Score

An evaluation of any one

determination to see how far it is

away from the mean.

34

Example:

Average = 109 mg/dl

SD

= 20 mg/dl

George = 105 mg/dl

SD

105m g / dl 109 m g / dl

F or G eorge :

0 .2 S D

2

0

m

g

/

d

l

What is the Z Score of Georges fasting plasma glucose?

35

Age

Sex

Diet

Medications

Physical activity

Pregnancy

Personal habits ( smoking, alcohol )

Geographic location ( altitude )

Body weight

Laboratory reagents

36

A minimum of 20 observations should be sampled in order to obtain valid

results ( but Ill use just 6 to save time )

Lets determine the normal range for fasting plasma glucose using 6 people:

Johns glucose

= 98 mg/dl

Pauls glucose

= 100 mg/dl

Georges glucose = 105 mg/dl

Ringos glucose = 150 mg/dl

Micks glucose = 102 mg/dl

Erics glucose

= 101 mg/dl

SD

= 20.0 mg/dl

2 SD

= 40.0 mg/dl

That means that the normal range for this group is from 109 40, or 69 - 149

which is 2.0 SD from the mean

Ringo is considered abnormal if we use this commonly accepted criteria to define normal and abnormal

By the way, the CV for this group of observations is about 18% - a fairly big dispersal about the mean

37

38

- FuelInjectorNozzles EnUploaded byVijayendran Vijay
- E2E_sensorproximidadUploaded by10811473
- Article1431614439_Freitas Et AlUploaded byJhon Méndez Arango
- Method VerificationUploaded byWaqarAhmedButt
- Six Sigma Executives Training Main Steps of a Six Sigma ProjectUploaded byLora Jackson
- Grade 7 Midterm Exam RevisonUploaded bygurcan
- Estatistic.docxUploaded byPedro Castro
- ia-rivers-2018-checklistUploaded byapi-244457674
- isdUploaded byRahul Tulsiani
- Cobb Breeder Guide 2008Uploaded byFaisal Mohommad
- CP CU1 Precise LineUploaded byLuis Fernando
- HorRat CIPAC Athens 2015Uploaded bymihaelasarateanu
- D4435Uploaded byOscar Eduardo
- Determination of quartz in kaolins by x-ray powder diffractometryUploaded byleandroassis_m
- eng 487 project 2Uploaded byapi-269264726
- psc.pdfUploaded byHum Nath Baral
- RichardsonUploaded byvinitb_3
- Climate ExtremesUploaded bysgrrsc
- DFSS1Uploaded bykoriom@live.com.au
- Mth507-Mathematics for Social Science (1)Uploaded bynikhilnoel
- chap7_603Uploaded bynaefmubarak
- C 167 - 98 _QZE2NY05OA__.pdfUploaded byCesar Jose Valdivia
- Guild Line 9340 Data SheetUploaded byVictor Pintado
- Project Ppt on SpicesUploaded byShilpa Dhawan
- Six Sigma-05012019Uploaded bymdriz_n
- BROC_FMP10-40_902-108_enUploaded byVasilisPapantinas
- 2429Uploaded byVictorAndresMillaSalazar
- Physics ATP NotesUploaded bySalman Virani
- Bulltin202700_E_030_1Uploaded bytooocoool
- Manihot Esculenta Research 2Uploaded byMarinelle Abulencia Robles

- 2. Introduction to Clinical ChemistryUploaded byEga Hida Prabowo
- Docking EgaUploaded byEga Hida Prabowo
- Tutorial Skenario 3 Ukak LambungUploaded byEga Hida Prabowo
- Perhitungan IsotonisUploaded byEga Hida Prabowo
- materiUploaded byEga Hida Prabowo
- FORM UMYUploaded byEga Hida Prabowo
- JADWAL-TERBANGUploaded byLaksamana Shanahan Muhsin
- Sosiologi Industri_OrganisasiUploaded byEga Hida Prabowo
- Tutorial Skenario 4 MalariaUploaded byEga Hida Prabowo
- jurnal fitomedisin brotowaliUploaded byvietra_ardian

- BITSAT Sample Paper 02Uploaded bykailash
- A Days Wait by Ernest HemingwayUploaded byyanina
- Online Treasure Hunt in Science 1Uploaded bySesang J Salibad
- John Bad Elk v. United States __ 177 U.S. 529 (1900) __ Justia U.SUploaded byJakk Kidd
- Philosophy Of Children’s Ministry, for a churchUploaded byMichal Gomulka
- 641- Review of State of Art of Smart Structures and Integrated SystemsUploaded bymohammadreza91
- Jurnal Pendukung ' Spirituality Self-care Effects on Quality of Life for Patients Diagnosed with Chronic Illness .pdfUploaded byIda Ayu Eni Pradnyandari
- International MarketingUploaded byKiran Virani
- 4 - interactionismUploaded byapi-200177496
- Kritsonis Teeter Totter Model SkinnerUploaded byapi-3747044
- Bussiness Communication- MB0039 (15 PAGES)Uploaded byHadji King
- assssement of public relations.docxUploaded byTilahun Mikias
- 20. Toledo vs HydenUploaded byZandrina Raterta
- 659 102 Making SenseUploaded byAbdul Yazid Nafii
- Commonly Confused WordsUploaded byNyamka
- Medialit CommentUploaded byIndozotero Mac
- The Cultural Industries-David Hesmondhalgh, 2nd Edition (Introduction)Uploaded byMireya Marquez Ramirez
- Multiple ChoiceUploaded bycarlo_scribd
- Introduction to Credibility Theory - Herzog, T.NUploaded byGustavo De La Rosa
- Resonance DPPUploaded byshambhavi26
- Sam Fischer Honours Thesis.pdfUploaded byAnonymous SxtNKJI6C
- Personality AdjectivesUploaded byaretiserene
- MeUploaded bygeogww4071
- Paulo LetterUploaded byZnevba Quintano
- Assignment on Tennyson's in MemoriamUploaded byAltaf Sheikh
- arsaprayoga.pdfUploaded byDhanur Dhara Dasa
- urban design processUploaded byDeepa Anoop
- 4Uploaded byDanyal Jawed
- Rev Febvre, Coming of the Book [Eisenstein]Uploaded byack67194771
- HR Policy ExcelUploaded byJyotirmoy Das