Hematology Westgard Rules in Good

Performance Laboratory

Rahmad Fuadi Prasetia, S.Si

Application Support
PT Saba Indomedika

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Presentation Agenda
• Quality Control • Frequently asked question
01 03
Review of current QC Practice in Hematology FAQ for Hematology QC in Westgard multy rules
application

• New Generation QC • Global survey and Troubleshoot

02 04
Westgard Rules + Six Sigma + QC Frequency Global QC practice survey and Troubleshoot

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 •1
• Quality Qontrol

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Quality Control
• Definition
A system of maintaining standards of outputs/results by
testing a sample of the output against the specification

• Purpose
Ensure that reported results are accountable

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Impact of Undetected Error
Clinical consequences of erroneous laboratory results that
went unnoticed for 10 days
Loh TP, Lee LC, Sethi SK et al. J Clin Pathol 2013; 166(3);260-1.
• 1 instrument error; 5 tests affected
• 63 results in error (15 patients)
• Potential clinical consequences: 2 repeat testing, 3 unnecessary
imaging procedures, 6 misdiagnoses
• Actual clinical consequences: 2 repeat testing, 1 unnecessary
imaging procedure
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Impact of Undetected Error

• Unnecessary cost incurred to patients

• Potentially harmful interventions

e.g. ionizing radiation from CT scan

• Misdiagnosis and mishandling of patient condition

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HOW DOES HEMATOLOGY DOING IN THE
LABORATORY ?
“ It is incongruous that the quality of today’s
multichannel hematology analyzer is generally
undisputed, yet the practice of hematology QC is
heterogeneous and seemingly arbitrary. It may be
that these analyzers are robust and usually produce
clinically acceptable data and that many of today’s
QC procedures are non-specific and lead to
nonproductive practices.”

IJLH, 2010, 32, 606-615

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OR SHOULD WE BE WORRYING ?

“ It is known that the use of both impedance

and automated analyzer still result some in some
inaccuracies in platelet measurement….

For the thresholds of 10, 20 x /L, inproportion of

inadequate transfusion was considerable.
Undertransfusion was observed with the use of
all four automated hematology analyzer.”

IJLH 2009:31:298-306

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QC Methods
• Levey-Jennings Chart First need to determine Mean & SD
of each lot of control in each lab1
20 measurements over >2 weeks or 10
days (ideally >4 weeks/20 days)
Can be repeated monthly and collated
as lot-to-date

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LJ Problem – Wrong Limits

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Normal Distribution

3 SD 2 SD 1 SD Target
Mean 1 SD 2 SD 3 SD

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Normal Distribution  LJ Chart

3 SD 2 SD 1 SD Mean 1 SD 2 SD 3 SD

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Levey-Jennings Chart: Example
Rules:
• 12s
• 13s
• 22s
• R4s
• 13s/22s/R4s

• Warning Rule
• Rejection Rule
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QC Rules

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 Before Westgard Rules (1960s)
• Labs only use one rule: 12s
• High False Rejection Rate (5%)
• Resources spent to troubleshoot

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Westgard Rules

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Westgard Rules
• Still too many false rejections! Sigma Metrics
• Indicator of test quality
• Not all tests needs all the rules
• Depends on test quality • Sigma = (TEa – bias)/CV
• When precision is very high, CV
becomes very tight  higher • Ideal: ≥ 6 sigma
chance of false rejections • Good: >4 sigma
• Problematic: <3 sigma
 Westgard Sigma Rules

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 •2
• New Generation QC

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TEa

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 •3
• Can I just use the manufacturer’s
mean and SD?
• Should I avoid using “Westgard
Rules” in hematology QC ?
• Isn’t it too hard to establish mean
and SD when my controls have such a
• Frequently asked
short lifespan ?
question for
Hematology QC

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Can I just use the manufacturer’s mean and SD?
ISO 15189 Technical Requirement :
“The laboratory shall design internal QC systems that verify the attainment of the intended quality of result.”

• Design = choose control rules, number of controls, frequency

• Verify = confirm that performance is acceptable
• Intended Quality = analytical performance specification

CLSI H26-A2 (Best practice for hematology QA)

• “The laboratory must establish its own mean expected mean and QC values of recovered control values. Published
manufacturers range are typically too board for effective QC”

• When you use control limits from the manufacturer, you are likely to be performing “blind QC man” – missing
error that are clinically important

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Should I avoid “westgard Rules” in hematology QC

• This is related to manufacturer ranges, 2 SD control limits, etc. Also related

to a problem with using full Westgard Rules on hematology QC –
particulary the 10x rule.

• CLSI H26-A2: “Multirule analysis is strongly recommended : Decision

based solely on +/- 2 SD are simplistic and insufficient. As Westgard notes,
‘The traditional use of the 1:2s warning control rule is no longer
recommended.’ Hierarchical selection of specific multirules that maximize
Ped and Pfr is recommended, using six sigma and power-function
approaches.”

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Isn’t it too hard to establish mean and SD when my controls
have such a short lifespan ?
• By the time you collect 20 data points, much of the lifespan of the control is already over

• Solution 1: Overlap controls by 3-5 days and make multiple measurements to establish
new mean and SD.

• Solution 2: use 8 overlapped value to establish new mean, use old CV to make temporary
“new” control
• New mean * old CV = temporary SD

• Solution 3: use cumulative mean and SD from multiple lots over 3 to 6 months (assuming
stable and consistent control performance)
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 •4
• Global QC practice
survey and
Troubleshoot

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HOW IS QC PRACTICED IN HEMATOLOGY ?

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ARE HEMATOLOGY LABS USING
“WESTGARD RULES” ?

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WHAT RANGES ARE HEMATOLOGY
LABORATORIES USING?

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QC TROUBLESHOOTING

Reagents
Operation OK?
OK?

Calibrators
Environment OK?
OK?

Maintenance
Instrument up to date?
OK?
Service OK?

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 Conclusions
• Majority used suboptimal
QC system
• High false rejections
• High unnecessary
spending on control
materials & calibrator

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Cost Savings from Westgard
Sigma

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Conclusion
• QC monitoring is crucial for ensuring results quality
• Impact on patient safety

• QC system needs to be optimized to minimize false

rejections while still being sensitive to errors
• Ensuring good quality while reducing resources spent on false
rejections

• Westgard Sigma Rules offer customization of QC system

based on test quality

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Thank you!
Any questions?

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 Practice 1 - PLT
CHC Quo Mean=34.60
Test=PLT Quo
QuoSD=0.85
Mean=59.00CalQuo
Platelet Mean=34.71
SD=12.00 CalCal
SD=0.41
Mean=59.36
Cal CV(%)=1.18
Cal SD=2.65 Cal CV(%)=4.46
59 Quoted Mean = 59
12 Quoted SD = 12
02-11-16 05:21 57
03-11-16 04:31 56
Calculated Mean = 59.36
04-11-16 04:54 58
Calculated SD = 2.65
05-11-16 05:08 59
Calculated CV(%) = 4.46
06-11-16 05:35 61
07-11-16 06:07 61
08-11-16 06:05 62
09-11-16 05:49 54
10-11-16 05:57 58
11-11-16 06:26 59
12-11-16 06:12 59
13-11-16 06:36 61
14-11-16 06:34 63
15-11-16 04:49 63
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 Levey Jennings Chart
Test=PLT Quo Mean = 59
02-11-16 05:21
Quo SD = 12
03-11-16 04:31 04-11-16 04:54 05-11-16 05:08
Cal Mean = 59.36
06-11-16 05:35 07-11-16 06:07 08-11-16 06:05
Cal SD = 2.65
09-11-16 05:49 10-11-16 05:57 11-11-16 06:26
Cal CV(%) = 4.46
12-11-16 06:12 13-11-16 06:36 14-11-16 06:34 15-11-16 04:49

95

83

71

59

47

35

23

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Levey Jennings Chart - Corrected
Test=PLT Quo Mean = 59 Quo SD = 12 Cal Mean = 59.36 Cal SD = 2.65 Cal CV(%) = 4.46

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Westgard Sigma Rules
• Sigma = (TEa - Bias)/CV
• TEa (CLIA) for PLT = 25%
• Bias% = [(59.36-59)/59]*100% = 0.61%
• CV = 4.46%
• Sigma = (25-0.61)/4.46 = 5.47

• Westgard Rules:

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