Six Sigma Application in

Clinical Laboratory

dr. Mastiar Endang Frida Siahaan, M.Kes., SpPK(K)

 Curriculum Vitae
dr. Mastiar Endang Frida Siahaan, M.Kes., SpPK(K)

1998 – 2005 : S1 Pendidikan Dokter FK UNSRI Palembang

2011 – 2015 : Pendidikan Dokter Spesialis Patologi Klinik FK UNS
Surakarta
2011 – 2014 : S-2 Magister Kesehatan FK UNS Surakarta
2018 - 2020 : Pendidikan Dokter Sub Spesialis Patologi Klinik Minat
Penyakit Infeksi FKKMK UGM Yogyakarta

2017 - sekarang : Kepala Instalasi Laboratorium Klinik RS Charitas Palembang

2018 - sekarang : Kepala Instalasi Laboratorium Klinik RS Ernaldi Bahar
Palembang
2016 - sekarang : Ketua PPI RS Charitas Palembang
2018 - sekarang : DLB FK UNSRI Palembang bagian Patologi Klinik
2019 - sekarang : Ketua Cabang PDS Patklin Palembang
Clinical Laboratory • one of the most important unit in hospital
• affect 60-70% critical decisions
(diagnosis, admission, discharge, drug
therapy)1
• the test result must accurate
Challenges:
✓ INCREASE workload
✓ INCREASE efficiency
✓ LOWER cost

Management Strategy

6σ
History ➢ carl frederick gauss (1977-1855): normal curve metric concept
➢ walter shewhart (1920’s): Three Sigma

• Motorola, Inc: Quality Problem (1979)

• Bill Smith: studying correlation between a
product’s field performance and the variation
and rework rate
• Mikel Harry: created statistical analysis to
improve product and reducing cost (Six
Sigma)

Aims:
1. reduce the cost of products
2. eliminate defect
3. decrease variability in processing
 Laboratory Quality Service

Cust
ome 6σ is a Quality
r Management
Strategy:
6σ ➢Defect
Emp Identification &
Proc
loye Removal
Goals: ess ➢Quality Process
✓ Customer satisfaction e
Improvement
✓ Excellent Quality
• Organizational change (cultural and procedural)
• Processes (design and improvement)
• Customer (focus on and analysis of)
• Metrics (statistics, performance, target)
• Employees (training, motivation, involvement)
Tahapan Six
Sigma

Measure:
Defect
Performance

“If we don’t measure → we don’t know

→ we can’t manage”
 negative exponential
correlation
between the value of
the σ level and the
number of defects

σ indicate how often the defects are defects per million opportunities
likely to occur (DPMO)
 Sigma value vs DPMO

σ level Defect, % Yield, % DPMO, n

1 69 31 691462
2 31 89 308538
3 6,7 93,3 66807
4 0,62 99,38 6210
5 0,023 99,977 233 Healthcare sector
6 0,00034 99,999966 3,4 “zero defect”
(world class)
Six Sigma Goals ✓ Eliminate Waste & Delays
✓ Lower Cost,Higher Speed
✓ Pra & Post Analytic

✓ Eliminate
Variation
✓ Culture &
Quality
✓ Analytic

Lean
 All laboratory procedures
Laboratory Process are prone to error

1. Test selection and ordering a

lab test request
2. Collecting the sample
3. Identification
4. Transport the sample to Pre-
analytical
laboratory
5. Preparation of the sample
6. Analysis
7. Reporting test results
8. Interpretation of test results Post-
analytical
9. Action
 Types & Rates of Laboratory Testing Process Error

Hammerling, JA. 2012. A Review of Medical Errors in Laboratory Diagnostics and Where We Are Today. LABMEDICINE .43 (2):41-44.
DOI:10.1309/LM6ER9WJR1IHQAUY
 Laboratory Performance: Calculate Total
Error of Each Phase

❖Problem-solving
Pre-analytic
method
❖Improve quality;
decrease defects, ❖Quantification of
reduce costs, Laboratory Performance
satisfy customer ❖Sigma = (TEa-bias )/CV
❖DMAIC
Sigma Scale

Post-analytic Analytic
Starting Six Sigma Laboratory Improvement Project

Improve
Define Measure Analyze Control
ment
• Bench • Value • Fishbon • Modelli • Measur
markin Stream e ng e
g Map Diagra • Toleran results
• Process • Cause & m ce • SPC
Flow Effect • FMEA Control Chart
Mappin • Defect • Root • Defect • Perfor
g Metrics Cause Control mance
SIPOC Diagram
Flowchart Process Pareto Chart
DEFECT
Rework
Cause & Effect
Diagram
Supplie Custom
Input Process Output
r er

Step 1 Step 1 Step 1 Step 1

FMEA
Value Stream Data (time, Data (time, Data (time, Data (time,
Mapping cost, sigma, cost, sigma, cost, sigma, cost, sigma, Root Cause
etc) etc) etc) etc) Analysis
80-20 Rule
 errors in
sample
collection

errors in test
requisition form
Improvement & Control Phase ✓new process
✓new flow charts
✓new SOP
✓training

New Flow Chart

New SOP

New Process

Pilot Study
Monitor & Control -- Statistical
Process Control
compare with baseline sigma
 D Issues: Goals:
25-30%
C M
✓ Sample Delay --> Reduce TAT
I A ✓ Potential biological Hazard --> Protect
Staff
Defect: Sample Mislabeling Error
Improvement:
✓ Low of Training personnel --> Training
✓ Low - quality Barcode --> New High Quality Barcode

✓ Error drop (30% to 3%)

✓ Potential Hazard drop
✓ Increase TAT (33h45m to
22.5m)
 Sigma Scale
• Analytic
• Useful in:
– defining QC rules
– monitoring quality on a daily basis (if the σ level of a test
suddenly drops --> analytical problem
– to compare the test performance between manufacturers

“Quantification of Test Performance”

 Sigma = (TEa-bias )/CV
• TEa = total error allowable (quality goal); (TEa as per CLIA 1988)
• Bias = systematic error of the assay
• CV = random errors; analytical SD or variation of the assay

QC Rules Design
 Bias (%)

• indicates systematic difference between

the laboratory’s test method result and
reference Reference:
• Calculated from external QC program ✓ Another test method
results ✓ Peer Group
Comparison
 CV (%)

• Coefficient of variation is calculated by

using standard deviation (SD) and mean
of the test
• Calculated from internal QC program
results
Westgard Sigma Rules
Sixma QC Design
As sigma metric
increases:
✓Fewer QC rules needed
✓Fewer controls needed
✓Fewer recalibrations
✓Fewer outliers
✓Fewer trouble shooting
experiences
✓Fewer technical support
calls and service visits.
Six Sigma Quote
H. James Harrington

Measurement is the first step

that leads to control and
eventually to improvement

if you can’t measure

something,
you can’t understand it

if you can’t understand it,

you can’t control it

if you can’t control it,

you can’t improve it