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Bio-Rad Laboratories IMMUNOHEMATOLOGY
Workflow Analysis Using the LSS Roadmap; Comparing Five Methodologies for Type & Screen
Testing Barbara Bachman, MS,MT(ASCP)SBB
Bio-Rad Laboratories, Inc.
December 5, 2014
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Objectives
At the end of this session, the participant will be able to:
Define some of the key principles, roadmap and methods of Lean Six
Sigma
Apply a portion of the LSS roadmap to evaluate Blood Group Serology testing methodologies
Explain the benefits of using LSS to evaluate automated testing platforms to meet facility goals and requirements
Bio-Rad Laboratories IMMUNOHEMATOLOGY
What is Lean Six Sigma?
Six Sigma vs Lean
Service &
Quality
Cost
Speed
~ Minimizes Variation
using Statistics
~ Eliminates / Reduces
Waste (NVA)
Submit Query
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Practically…
99.99966% Good
7 Lost Articles / Hr
1 Short / Long Per 5 Years
68 Wrong Drug Prescriptions / Yr
6s
99% Good
Postal System
20,000 Lost Articles of Mail / Hr
Airline System Two Short / Long Landings / Day
Medical Profession 200,000 Wrong Drug Prescriptions / Yr
4s
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Six Sigma & Lean
Define
Measure
Analyze
Improve
Control
Run Charts
Box Plots / Histograms / Scatter Diagrams
Process Mapping
Pareto Analysis
C&E Diagram / Fishbone Diagram
5S
Generic Pull Work Control Systems
Setup Time / Changeover Reduction
LEAN Tools
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Superiority of Lean Six Sigma
•GENERAL
• Structured Roadmap for PI Activities
• Organizational Infrastructure
•DEFINE
• Customer Requirements
•MEASURE
• QC Test for Measurement System
• Process Capability Analysis
Cost
Quality Speed
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Define
Project Focus / VOB / VOC
In Scope / Out of Scope
Key Metrics
Team / Facilities
High Level Process Map
Operational Definitions
Define
Quality &
Speed
# of Process Steps
# of Opportunities for Error
Tech “Hands On” Time
T&S
Small to Large
Manual & Automated Methods
Bio-Rad Laboratories IMMUNOHEMATOLOGY
• Workload Variation
• Size of Facility / Workflow patterns
• Tech (dedicated staff), Shift, Day/Weekend
• Observation Limitations
• Major Element of Quality = Defects
• Process Steps
• Centrifugation Times – Specimen Prep
• Information Systems – Results Reporting
• Quality • Sensitivity & Specificity of Results
Limitations of Study/Scoped Out
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Define - Methods
Methods Evaluated
•Manual Methods
• Tube
• Gel - Ortho
•Automated
• Tango optimo - SSII
(Bio-Rad)
• Provue – Gel
(Ortho)
• Echo – SPRCA
(Immucor)
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Define – Select Team Provue
Medium (10-15,000 T&S/Yr)
William Beaumont Army
Medical Center (WBAMC),
Fort Bliss, TX
Tango optimo
Large (>15,000 T&S/Yr)
San Antonio Military Medical Center (SAMMC),
San Antonio, TX
Manual Tube
Small (<10,000 T&S/Yr)
Christus Santa Rosa Children’s Hospital,
San Antonio, TX
Echo & Manual Gel
Medium (10-15,000 T&S/Yr)
Carl R. Darnall Army
Medical Center (CRDAMC),
Fort Hood, TX
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Receive / Accept Specimen
Prepare for Testing
Perform Test
Interpret / Verify
Report Results
Define – High Level Process Map
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Define - Operational Definitions
• Number of Process Steps - Includes each block/decision point in the
process maps (If decisions impacted total number of steps, used the average)
• Opportunities for Error - Includes every possibly point at which an error can
be made (Example – Echo uses various strips, Tango uses two microplates)
• Tech “Hands On” Time – Includes tech “touch” time
• Small Facility – Performs < 10,000 T&S procedures annually
• Medium Facility – Performs 10 – 15,000 T&S procedures annually
• Large Facility – Performs >15,000 T&S procedures annually
• Manual Testing – Includes Tube and Gel Testing
• Automated Testing – Includes Echo, Provue, Tango optimo
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Measure
Low Level/Detailed Process Map
Finalize Operational Definitions
Establish Data Collection Plan
Measurement System Analysis
Data Collection
Process Performance / Capability
Measure
Validate Measurement
Systems
Normal / Non-Normal data?
Stable? In control?
# of Process Steps
# of Opportunities for Error
Tech “Hands On” Time
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Manual Tube Testing – Workflow Analysis (Type & Screen Procedure)
Receiving Tech Testing / Certifying Tech
Receive & Accept Specimen
Centrifuge Specimens
(5 min)
Request for Trauma / OR /
ER?
Emergency Release Procedure
Yes
Label Tubes appropriately
Add Reagents
Add Patient Sample
Enter Test Results
Locate appropriate
tests ordered
Certify Test Results - Stop
No
Locate patient in Hospital LIS; Prepare
Electronic Testing Worksheet
Incubate ABS Tubes at 37C (min of 10 min)
Centrifuge Tubes
Interpret Results
Record Results
Read Results
Add Enhancement
Reagent
Incubate ABS Tubes at 37C
Centrifuge Tubes
Interpret Results
Record Results
Read Results
Add AHG
Any Tubes with Negative Results?
Yes
Add Check Cells
Centrifuge Tubes
Read Results
Interpret Results
Record Results
No
Workflow process obtained from
Christus Santa Rosa Medical Center, San
Antonio, TX.
Centrifuge Tubes
Interpret Results
Record ABO/Rh Results
Read Results
32 Total Steps with 124 Opportunities/
Procedure for Human Error
Measure – Tube Process Map
Electronic Data
Manual Step
Decision Point
Separate /
Sub-Process
Start / Stop
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer willing to pay for
Manual Tube Testing – Workflow Analysis (Type & Screen Procedure)
Receiving Tech Testing / Certifying Tech
Receive & Accept Specimen
Receive & Accept Specimen
Centrifuge Specimens
(5 min)
Centrifuge Specimens
(5 min)
Request for Trauma / OR /
ER?
Request for Trauma / OR /
ER?
Emergency Release Procedure
Emergency Release Procedure
Yes
Label Tubes appropriately
Label Tubes appropriately
Add Reagents
Add Reagents
Add Patient Sample
Add Patient Sample
Enter Test ResultsEnter Test Results
Locate appropriate
tests ordered
Locate appropriate
tests ordered
Certify Test Results - Stop
Certify Test Results - Stop
No
Locate patient in Hospital LIS; Prepare
Electronic Testing Worksheet
Locate patient in Hospital LIS; Prepare
Electronic Testing Worksheet
Incubate ABS Tubes at 37C (min of 10 min)
Incubate ABS Tubes at 37C (min of 10 min)
Centrifuge Tubes
Centrifuge Tubes
Interpret Results
Interpret Results
Record Results
Record Results
Read Results
Read Results
Add Enhancement
Reagent
Add Enhancement
Reagent
Incubate ABS Tubes at 37C
Incubate ABS Tubes at 37C
Centrifuge Tubes
Centrifuge Tubes
Interpret Results
Interpret Results
Record Results
Record Results
Read Results
Read Results
Add AHGAdd AHG
Any Tubes with Negative Results?
Any Tubes with Negative Results?
Yes
Add Check CellsAdd Check Cells
Centrifuge Tubes
Centrifuge Tubes
Read ResultsRead Results
Interpret Results
Interpret Results
Record ResultsRecord Results
No
Workflow process obtained from
Christus Santa Rosa Medical Center, San
Antonio, TX.
Centrifuge Tubes
Centrifuge Tubes
Interpret Results
Interpret Results
Record ABO/Rh Results
Record ABO/Rh Results
Read Results
Read Results
32 Total Steps with 124 Opportunities/
Procedure for Human Error
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Tango optimo – Workflow Analysis (Type & Screen Procedure)
Receiving Tech Tango optimo Testing Certifying Tech
Centrifuge Specimens
(5 min)
Request for Trauma / OR /
ER?
Emergency Release Procedures and/or
Manual Testing
Yes
Receive & Accept Specimen
Uncap & Place
Specimen on Tango
Tests Ordered electronically?
Yes
Print Label & Affix to Sample
No
Adequate Supplies & Reagents
On Board?
Load necessary reagents &
supplies
No
Select “Start”
Find Patient in Blood Bank LIS
Enter Test Results
Review / Verify Results for Acceptable Performance
Results electronically Certified in Hospital LIS
- STOP
Yes
12-14 Total Steps with 121 Opportunities/Procedure
for Human Error
Certify Results in Blood Bank LIS -
STOP
Workflow process obtained from San Antonio Military Medical Center,
JBSA -Fort Sam Houston, TX.
No
Identify Patient & Order/Select
Appropriate Tests
Echo vs Tango Process Map
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer willing to pay for
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Echo vs Tango Process Map
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer willing to pay for
13 Sub-Steps
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Tango optimo – Workflow Analysis (Type & Screen Procedure)
Receiving Tech Tango optimo Testing Certifying Tech
Centrifuge Specimens
(5 min)
Request for Trauma / OR /
ER?
Emergency Release Procedures and/or
Manual Testing
Yes
Receive & Accept Specimen
Uncap & Place
Specimen on Tango
Tests Ordered electronically?
Yes
Print Label & Affix to Sample
No
Adequate Supplies & Reagents
On Board?
Load necessary reagents &
supplies
No
Select “Start”
Find Patient in Blood Bank LIS
Enter Test Results
Review / Verify Results for Acceptable Performance
Results electronically Certified in Hospital LIS
- STOP
Yes
12-14 Total Steps with 121 Opportunities/Procedure
for Human Error
Certify Results in Blood Bank LIS -
STOP
Workflow process obtained from San Antonio Military Medical Center,
JBSA -Fort Sam Houston, TX.
No
Identify Patient & Order/Select
Appropriate Tests
Echo vs Tango Process Map
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer willing to pay for
5 Sub-Steps
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Measure – Process Maps Summary Manual Tube Testing – Workflow Analysis (Type & Screen Procedure)
Receiving Tech Testing / Certifying Tech
Receive & Accept Specimen
Centrifuge Specimens
(5 min)
Request for Trauma / OR /
ER?
Emergency Release Procedure
Yes
Label Tubes appropriately
Add Reagents
Add Patient Sample
Enter Test Results
Locate appropriate
tests ordered
Certify Test Results - Stop
No
Locate patient in Hospital LIS; Prepare
Electronic Testing Worksheet
Incubate ABS Tubes at 37C (min of 10 min)
Centrifuge Tubes
Interpret Results
Record Results
Read Results
Add Enhancement
Reagent
Incubate ABS Tubes at 37C
Centrifuge Tubes
Interpret Results
Record Results
Read Results
Add AHG
Any Tubes with Negative Results?
Yes
Add Check Cells
Centrifuge Tubes
Read Results
Interpret Results
Record Results
No
Workflow process obtained from
Christus Santa Rosa Medical Center, San
Antonio, TX.
Centrifuge Tubes
Interpret Results
Record ABO/Rh Results
Read Results
32 Total Steps with 124 Opportunities/
Procedure for Human Error
Manual Gel – Workflow Analysis (Type & Screen Procedure)
Reviewing / Certifying Tech
Testing TechReceiving Tech
Receive & Accept Specimen
Centrifuge Specimens
(10 min)
Request for Trauma / OR /
ER?
Emergency Release Procedure
Yes
Label Gel Cards with Patient Identifiers
No
Add Reagents
Add Patient Sample
Incubate Gel Cards
Centrifuge Gel Cards
Prepare Hard Copy Testing Worksheet
Interpret Results
Record Results Locate Patient in
Blood Bank LIS
Locate appropriate tests ordered
Enter Test Results
Locate appropriate tests ordered
Verify Test Results
Locate Patient in Hospital LIS
Locate appropriate tests ordered
Certify Test Results - Stop
23 Total Steps with 117 Opportunities/
Procedure for Human Error
Locate Patient in Blood Bank LIS
Workflow process obtained from Carl R. Darnall Army Medical Center, Fort Hood, TX.
Centrifuge Gel Cards
Interpret Results
Record Results
Manual vs Automated Methods
• Six Sigma
• Minimize # of Steps
• Opportunities for Error?
• Lean - VA, NVA-R, NVA
Gel
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Measure – Opportunities for Error
• Quality Metric – Opportunities for Error
• Automation removes multiple opportunities for error Method # Total Steps Hands On Opportunities
for Error
Tube 32 124
Gel 23 122
Echo 20 26
Provue 22 30
Tango 13 15
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Measurement System Analysis
Conditions • Measurement System in
statistical control
• Variation in Measurement
System MUST be small
• relative to process
• relative to specification limits
• Level of Discrimination at 1/10
of process variability
What kind of data are you working
with?
Attribute / Discrete Data
(Yes/No, Pass/Fail, Go/No Go)
Continuous / Variable Data(Measurements, Temperatures,
Times, Weights)
Perform MSA –
Gage R&RPerform MSA
Attribute or Ordinal?
Attribute (Award / No Award,
Yes / No)
Ordinal (-2, -1, 0, 1, 2)
Perform a Kappa
Statistical Analysis
Perform
Kendal’s Coefficient
Statistic
QC for your Measurement System!
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Gage R&R
%Contribution
Source VarComp (of VarComp)
Total Gage R&R 0.0073 0.02
Repeatability 0.0073 0.02
Reproducibility 0.0000 0.00
Part-To-Part 29.8523 99.98
Total Variation 29.8596 100.00
Study Var %Study Var
Source StdDev (SD) (6 * SD) (%SV)
Total Gage R&R 0.08554 0.5133 1.57
Repeatability 0.08554 0.5133 1.57
Reproducibility 0.00000 0.0000 0.00
Part-To-Part 5.46373 32.7824 99.99
Total Variation 5.46440 32.7864 100.00
Number of Distinct Categories = 90
Measure - Gage R&R
Pe
rce
nt
Part-to-PartReprodRepeatGage R&R
100
50
0
% Contribution
% Study Var
Sa
mp
le R
an
ge 0.30
0.15
0.00
_R=0.133
UCL=0.3424
LCL=0
1 2 3S
am
ple
Me
an
16
8
0
__X=4.16UCL=4.29LCL=4.02
1 2 3
Appraiser
Part Number
321
109876543211098765432110987654321
16
8
0
Appraiser
321
16
8
0
Components of Variation
R Chart by Appraiser
Xbar Chart by Appraiser
Measurements By Part Number ( Appraiser )
Measurements by Appraiser
Gage R&R (Nested) for Measurements
Facility clocks and/or the stopwatch times were acceptable for time
studies conducted based on the Gage R&R.
Bio-Rad Laboratories IMMUNOHEMATOLOGY
• Graphical Summaries
• p values >0.05 indicates data is normally distributed
• P values <0.05 indicates data is NOT normally distributed
• Pre-determined Metrics
• # of Process Steps
• Opportunities for Error
• “Hands On” Time
• What does it matter?
Data – Is it Normal?
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Tube Data – Is it Normal?
108642
Median
Mean
5.255.004.754.504.254.00
1st Quartile 3.3500
Median 4.3000
3rd Quartile 5.8000
Maximum 10.5000
4.0130 5.1230
3.8672 4.7328
1.6314 2.4337
A-Squared 0.69
P-Value 0.068
Mean 4.5680
StDev 1.9530
Variance 3.8141
Skewness 0.83604
Kurtosis 1.02330
N 50
Minimum 1.0000
Anderson-Darling Normality Test
95% Confidence Interval for Mean
95% Confidence Interval for Median
95% Confidence Interval for StDev95% Confidence Intervals
Tube Tech "Hands On" Time
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Data - In Control / Stable?
Observation
Ind
ivid
ua
l Va
lue
464136312621161161
10.0
7.5
5.0
2.5
0.0
_X=4.57
UCL=10.43
LCL=-1.29
Observation
Mo
vin
g R
an
ge
464136312621161161
8
6
4
2
0
__MR=2.203
UCL=7.198
LCL=0
1
1
I-MR Chart of Total Hands on Time
Telephone interruption
Supervisor Performing Test
Bio-Rad Laboratories IMMUNOHEMATOLOGY
• Measures if process meets customer’s “Target” / requirements
• The extent to which the “expected” values fall within these limits
determines how capable the process is of meeting the
requirements.
• So what is “Acceptable Performance” for the customer?
Measure - Process Capability
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Analyze
Identify Critical Inputs (“X’s”) / Multi-Vary Analysis
Graphs / Visual Representations
Identify Root Causes
Prioritize Root Causes
Statistical Analysis
Perform Root Cause Analysis on Critical “X’s”
Analyze
Analysis of
Variation
(ANOVA)
Non-normal data
Boxplots
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Histogram Boxplots
Analyze – Graphs/Visuals
LSS generally uses a visual representation
first, then verifies “Appearances” with the
appropriate statistical test.
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Analyze – “Hands On” Time
One-way ANOVA: Hands on Time; All Methods
Source DF SS MS F P
Factor 4 6963.0 1740.8 44.86 0.000
Error 245 9507.6 38.8
Total 249 16470.6
S = 6.229 R-Sq = 42.28% R-Sq(adj) = 41.33%
F > 1 & p<0.05, thus at least one
method is significantly different than
the others for “Hands On” Time.
Tukey’s pairwise comparisons confirm:
• Manual Tube & Gel methods “hands on”
times are significantly different than
automated methods.
• There is no significant difference between
the automated methods regarding “hands
on” time.
Individual 95% CIs For Mean Based on
Pooled StDev
Level N Mean StDev ---+---------+---------+---------+------
Tube Hands on Ti 50 16.206 10.950 (----*---)
Gel Hands on Tim 50 15.532 7.816 (----*---)
Echo Hands on Ti 50 6.228 2.539 (----*---)
Provue Hands on 50 4.716 1.667 (----*---)
Tango Hands on T 50 4.568 1.953 (---*----)
---+---------+---------+---------+------
4.0 8.0 12.0 16.0
Bio-Rad Laboratories IMMUNOHEMATOLOGY
LSS Summary…
Reviewed what LSS is; Focus of Quality, Speed & Cost Six Sigma Reduce variation/improve quality,
Focus on statistical analysis,
Provides Organizational Structure & DMAIC Roadmap
Provides a Method to QC the Measurement System
Lean Reduces waste/Non-Value Added (NVA)
Focus on Speed
Used a portion of the LSS Roadmap (DMAIC) to Evaluate Blood Serology testing methodologies used in Transfusion Services Manual Methods vs Automated Methods
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Method Comparison Findings
Overall Automated Methods significant improvement over Manual Testing
Quality - # of Steps & Opportunities for Error Tango – Least # of Steps
Tango – Least # of Opportunities for Error
Speed Tango – Best “Hands On” Time (Look Deeper)
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Future Studies…
Compare Automated Methods - similar workloads
Evaluate DEFECTS to determine Process Performance
(Sigma Quality Level)
Evaluate Testing Times against Manufacturer’s
Published Specs
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Measure – Gel Process Map Manual Gel – Workflow Analysis (Type & Screen Procedure)
Reviewing / Certifying Tech
Testing TechReceiving Tech
Receive & Accept Specimen
Receive & Accept Specimen
Centrifuge Specimens
(10 min)
Centrifuge Specimens
(10 min)
Request for Trauma / OR /
ER?
Request for Trauma / OR /
ER?
Emergency Release Procedure
Emergency Release Procedure
Yes
Label Gel Cards with Patient Identifiers
Label Gel Cards with Patient Identifiers
No
Add Reagents
Add Reagents
Add Patient SampleAdd Patient Sample
Incubate Gel Cards
Incubate Gel Cards
Centrifuge Gel Cards
Centrifuge Gel Cards
Prepare Hard Copy Testing Worksheet
Prepare Hard Copy Testing Worksheet
Interpret Results
Interpret Results
Record Results
Record Results Locate Patient in
Blood Bank LIS
Locate Patient in Blood Bank LIS
Locate appropriate tests ordered
Locate appropriate tests ordered
Enter Test ResultsEnter Test Results
Locate appropriate tests ordered
Locate appropriate tests ordered
Verify Test ResultsVerify Test Results
Locate Patient in Hospital LIS
Locate Patient in Hospital LIS
Locate appropriate tests ordered
Locate appropriate tests ordered
Certify Test Results - Stop
Certify Test Results - Stop
23 Total Steps with 117 Opportunities/
Procedure for Human Error
Locate Patient in Blood Bank LIS
Locate Patient in Blood Bank LIS
Workflow process obtained from Carl R. Darnall Army Medical Center, Fort Hood, TX.
Centrifuge Gel Cards
Centrifuge Gel Cards
Interpret Results
Interpret Results
Record Results
Record Results
Electronic Data
Manual Step
Decision Point
Separate /
Sub-Process
Start / Stop
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer willing to pay for
T
I
M
W
O
O
D
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Immucor Echo – Workflow Analysis (Type & Screen Procedure)
Immucor Echo Testing Certifying TechReceiving Tech
Centrifuge Specimens
Request for Trauma / OR /
ER?
Emergency Release Procedures and/or
Manual Testing
Yes
Receive & Accept Specimen
Uncap & Place
Specimen on Echo
Tests Ordered electronically?
Identify Patient & Order/Select
Appropriate Tests
Adequate Supplies & Reagents
On Board?
Load other reagents &
supplies
No
Select “Start”
Find Patient in Blood Bank LIS
Find appropriate tests ordered
Enter Test ResultsFind Patient in Hospital LIS
Enter Test Results
Review / Verify Results for Acceptable Performance
Find appropriate tests ordered
Yes
Results electronically Certified in Hospital LIS
- STOP
19-21 Total Steps with 133 Opportunities/Procedure
for Human Error
Certify Results in Blood Bank LIS -
STOP
Yes
No
Workflow process obtained from Carl R. Darnall Army Medical
Center, Fort Hood, TX.
Select appropriate
strips
Load Strips on
Microplate
No
Print Labels & Affix to Sample Tube
Measure – Echo Process Map
Electronic Data
Manual Step
Decision Point
Separate /
Sub-Process
Start / Stop
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer willing to pay for
Immucor Echo – Workflow Analysis (Type & Screen Procedure)
Immucor Echo Testing Certifying TechReceiving Tech
Centrifuge Specimens
Centrifuge Specimens
Request for Trauma / OR /
ER?
Request for Trauma / OR /
ER?
Emergency Release Procedures and/or
Manual Testing
Emergency Release Procedures and/or
Manual Testing
Yes
Receive & Accept Specimen
Receive & Accept Specimen
Uncap & Place
Specimen on Echo
Uncap & Place
Specimen on Echo
Tests Ordered electronically?
Tests Ordered electronically?
Identify Patient & Order/Select
Appropriate Tests
Identify Patient & Order/Select
Appropriate Tests
Adequate Supplies & Reagents
On Board?
Adequate Supplies & Reagents
On Board?
Load other reagents &
supplies
Load other reagents &
supplies
No
Select “Start”Select “Start”
Find Patient in Blood Bank LIS
Find Patient in Blood Bank LIS
Find appropriate tests ordered
Find appropriate tests ordered
Enter Test ResultsEnter Test ResultsFind Patient in Hospital LIS
Find Patient in Hospital LIS
Enter Test ResultsEnter Test Results
Review / Verify Results for Acceptable Performance
Review / Verify Results for Acceptable Performance
Find appropriate tests ordered
Find appropriate tests ordered
Yes
Results electronically Certified in Hospital LIS
- STOP
Results electronically Certified in Hospital LIS
- STOP
19-21 Total Steps with 133 Opportunities/Procedure
for Human Error
Certify Results in Blood Bank LIS -
STOP
Certify Results in Blood Bank LIS -
STOP
Yes
No
Workflow process obtained from Carl R. Darnall Army Medical
Center, Fort Hood, TX.
Select appropriate
strips
Select appropriate
strips
Load Strips on
Microplate
Load Strips on
Microplate
No
Print Labels & Affix to Sample Tube
Print Labels & Affix to Sample Tube
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Ortho ProVue – Workflow Analysis (Type & Screen Procedure)
Certifying TechReceiving Tech ProVue Testing
START - Receive & Accept Specimen
Label Gel Card(s) with
Patient Identifiers
Able to Run Specimens on
ProVue?
Load Patient Specimens
onto ProVue
Yes
Centrifuge Specimens
Request for Trauma / OR /
ER?No
Locate Patient in Blood Bank LIS
Locate appropriate tests ordered
Enter Test Results
Locate Patient in Hospital LIS
Enter Test Results
Go To Manual Gel Testing Flowchart
No
Emergency Release Procedures and/or
Manual Testing
Yes
Tests Ordered Electronically?
No
Yes
Adequate Reagents & Supplies
on Board?Yes
Select “Start” / “Run”
No
Enter Patient Identifiers
Load Necessary Reagents &
Supplies
Review / Verify Results for Acceptable
Performance
Locate appropriate tests ordered
Certify Results - STOP
Certify Results - STOP
Select appropriate tests
Uncap & Place Specimen on
ProVue
21-23 Total Steps with 122 Opportunities/Procedure
for Human ErrorWorkflow process obtained from William Beaumont Army Medical
Center, El Paso, TX.
Print Labels & Affix to Sample Tube
Separate Process
Measure – Provue Process Map
Electronic Data
Manual Step
Decision Point
Separate /
Sub-Process
Start / Stop
Ortho ProVue – Workflow Analysis (Type & Screen Procedure)
Certifying TechReceiving Tech ProVue Testing
START - Receive & Accept Specimen
START - Receive & Accept Specimen
Label Gel Card(s) with
Patient Identifiers
Label Gel Card(s) with
Patient Identifiers
Able to Run Specimens on
ProVue?
Able to Run Specimens on
ProVue?
Load Patient Specimens
onto ProVue
Load Patient Specimens
onto ProVue
Yes
Centrifuge Specimens
Centrifuge Specimens
Request for Trauma / OR /
ER?
Request for Trauma / OR /
ER?No
Locate Patient in Blood Bank LIS
Locate Patient in Blood Bank LIS
Locate appropriate tests ordered
Locate appropriate tests ordered
Enter Test ResultsEnter Test Results
Locate Patient in Hospital LIS
Locate Patient in Hospital LIS
Enter Test ResultsEnter Test Results
Go To Manual Gel Testing Flowchart
Go To Manual Gel Testing Flowchart
No
Emergency Release Procedures and/or
Manual Testing
Emergency Release Procedures and/or
Manual Testing
Yes
Tests Ordered Electronically?
Tests Ordered Electronically?
No
Yes
Adequate Reagents & Supplies
on Board?
Adequate Reagents & Supplies
on Board?Yes
Select “Start” / “Run”
Select “Start” / “Run”
No
Enter Patient Identifiers
Enter Patient Identifiers
Load Necessary Reagents &
Supplies
Load Necessary Reagents &
Supplies
Review / Verify Results for Acceptable
Performance
Review / Verify Results for Acceptable
Performance
Locate appropriate tests ordered
Locate appropriate tests ordered
Certify Results - STOP
Certify Results - STOP
Certify Results - STOP
Certify Results - STOP
Select appropriate tests
Select appropriate tests
Uncap & Place Specimen on
ProVue
Uncap & Place Specimen on
ProVue
21-23 Total Steps with 122 Opportunities/Procedure
for Human ErrorWorkflow process obtained from William Beaumont Army Medical
Center, El Paso, TX.
Print Labels & Affix to Sample Tube
Print Labels & Affix to Sample Tube
Separate ProcessSeparate Process
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer
willing to pay for
Workflow process obtained from William Beaumont Army Medical
Center, El Paso, TX.
T
I
M
W
O
O
D
Bio-Rad Laboratories IMMUNOHEMATOLOGY
Tango optimo – Workflow Analysis (Type & Screen Procedure)
Receiving Tech Tango optimo Testing Certifying Tech
Centrifuge Specimens
(5 min)
Centrifuge Specimens
(5 min)
Request for Trauma / OR /
ER?
Request for Trauma / OR /
ER?
Emergency Release Procedures and/or
Manual Testing
Emergency Release Procedures and/or
Manual Testing
Yes
Receive & Accept Specimen
Receive & Accept Specimen
Uncap & Place
Specimen on Tango
Uncap & Place
Specimen on Tango
Tests Ordered electronically?
Tests Ordered electronically?
Yes
Print Label & Affix to Sample
Print Label & Affix to Sample
No
Adequate Supplies & Reagents
On Board?
Adequate Supplies & Reagents
On Board?
Load necessary reagents &
supplies
Load necessary reagents &
supplies
No
Select “Start”Select “Start”
Find Patient in Blood Bank LIS
Find Patient in Blood Bank LIS
Enter Test ResultsEnter Test Results
Review / Verify Results for Acceptable Performance
Review / Verify Results for Acceptable Performance
Results electronically Certified in Hospital LIS
- STOP
Results electronically Certified in Hospital LIS
- STOP
Yes
12-14 Total Steps with 121 Opportunities/Procedure
for Human Error
Certify Results in Blood Bank LIS -
STOP
Certify Results in Blood Bank LIS -
STOP
Workflow process obtained from San Antonio Military Medical Center,
JBSA -Fort Sam Houston, TX.
No
Identify Patient & Order/Select
Appropriate Tests
Identify Patient & Order/Select
Appropriate Tests
Tango optimo – Workflow Analysis (Type & Screen Procedure)
Receiving Tech Tango optimo Testing Certifying Tech
Centrifuge Specimens
(5 min)
Request for Trauma / OR /
ER?
Emergency Release Procedures and/or
Manual Testing
Yes
Receive & Accept Specimen
Uncap & Place
Specimen on Tango
Tests Ordered electronically?
Yes
Print Label & Affix to Sample
No
Adequate Supplies & Reagents
On Board?
Load necessary reagents &
supplies
No
Select “Start”
Find Patient in Blood Bank LIS
Enter Test Results
Review / Verify Results for Acceptable Performance
Results electronically Certified in Hospital LIS
- STOP
Yes
12-14 Total Steps with 121 Opportunities/Procedure
for Human Error
Certify Results in Blood Bank LIS -
STOP
Workflow process obtained from San Antonio Military Medical Center,
JBSA -Fort Sam Houston, TX.
No
Identify Patient & Order/Select
Appropriate Tests
Measure – Tango Process Map
Electronic Data
Manual Step
Decision Point
Separate /
Sub-Process
Start / Stop
Waste, Non-Value Added
Non-Value Added, Required
Value Added, Customer willing to pay for
Recommended