Workflow Analysis Using the LSS Roadmap; Comparing Five ...2F82162C-6430-4E94... · Bio-Rad Laboratories IMMUNOHEMATOLOGY Workflow Analysis Using the LSS Roadmap; Comparing Five Methodologies

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


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


What is Lean Six Sigma?

Six Sigma vs Lean

Service &

Quality

Cost

Speed

~ Minimizes Variation

using Statistics

~ Eliminates / Reduces

Waste (NVA)

Submit Query


What is Six Sigma?


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


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


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


Workflow Analysis

DEFINE


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


• 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


Define - Methods

Methods Evaluated

•Manual Methods

• Tube

• Gel - Ortho

•Automated

• Tango optimo - SSII

(Bio-Rad)

• Provue – Gel

(Ortho)

• Echo – SPRCA

(Immucor)


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

http://www.destination360.com/categories/656/edit

http://www.destination360.com/categories/657/edit


Receive / Accept Specimen

Prepare for Testing

Perform Test

Interpret / Verify

Report Results

Define – High Level Process Map


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


Measure

MEASURE


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


Measure – Map the Process


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)





(5 min)


(5 min)


ER?


ER?



Yes



Add Reagents

Add Reagents

Add Patient Sample

Add Patient Sample

Enter Test ResultsEnter Test Results

Locate appropriate

tests ordered

Locate appropriate

tests ordered



No







Centrifuge Tubes

Centrifuge Tubes

Interpret Results

Interpret Results

Record Results

Record Results

Read Results

Read Results

Add Enhancement

Reagent

Add Enhancement

Reagent



Centrifuge Tubes

Centrifuge Tubes

Interpret Results

Interpret Results

Record Results

Record Results

Read Results

Read Results

Add AHGAdd AHG



Yes

Add Check CellsAdd Check Cells

Centrifuge Tubes

Centrifuge Tubes

Read ResultsRead Results

Interpret Results

Interpret Results

Record ResultsRecord Results

No



Antonio, TX.

Centrifuge Tubes

Centrifuge Tubes

Interpret Results

Interpret Results



Read Results

Read Results




Tango optimo – Workflow Analysis (Type & Screen Procedure)

Receiving Tech Tango optimo Testing Certifying Tech


(5 min)


ER?

Emergency Release Procedures and/or

Manual Testing

Yes


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









13 Sub-Steps





(5 min)


ER?


Manual Testing

Yes


Uncap & Place

Specimen on Tango


Yes


No


On Board?


supplies

No

Select “Start”


Enter Test Results



- STOP

Yes


for Human Error


STOP



No


Appropriate Tests





5 Sub-Steps


Measure – Process Maps Summary Manual Tube Testing – Workflow Analysis (Type & Screen Procedure)




(5 min)


ER?


Yes


Add Reagents

Add Patient Sample

Enter Test Results

Locate appropriate

tests ordered


No




Centrifuge Tubes

Interpret Results

Record Results

Read Results

Add Enhancement

Reagent


Centrifuge Tubes

Interpret Results

Record Results

Read Results

Add AHG


Yes

Add Check Cells

Centrifuge Tubes

Read Results

Interpret Results

Record Results

No



Antonio, TX.

Centrifuge Tubes

Interpret Results


Read Results



Manual Gel – Workflow Analysis (Type & Screen Procedure)

Reviewing / Certifying Tech

Testing TechReceiving Tech



(10 min)


ER?


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


Verify Test Results

Locate Patient in Hospital LIS





Locate Patient in Blood Bank LIS

Workflow process obtained from Carl R. Darnall Army Medical Center, Fort Hood, TX.


Interpret Results

Record Results

Manual vs Automated Methods

• Six Sigma

• Minimize # of Steps

• Opportunities for Error?

• Lean - VA, NVA-R, NVA

Gel


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


Operational Definitions – Developed Data Collection Plan


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!


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.



• 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?


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


Data – In Control / Stable?


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


• 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


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


Histogram Boxplots

Analyze – Graphs/Visuals

LSS generally uses a visual representation

first, then verifies “Appearances” with the

appropriate statistical test.


Analyze - Boxplots


Inter-Method Analysis - Prep

Tube Gel Echo Provue Tango


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


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


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)


Future Studies…

Compare Automated Methods - similar workloads

Evaluate DEFECTS to determine Process Performance

(Sigma Quality Level)

Evaluate Testing Times against Manufacturer’s

Published Specs


Questions?


Measure – Gel Process Map Manual Gel – Workflow Analysis (Type & Screen Procedure)

Reviewing / Certifying Tech

Testing TechReceiving Tech




(10 min)


(10 min)


ER?


ER?



Yes



No

Add Reagents

Add Reagents

Add Patient SampleAdd Patient Sample

Incubate Gel Cards

Incubate Gel Cards





Interpret Results

Interpret Results

Record Results

Record Results Locate Patient in

Blood Bank LIS







Verify Test ResultsVerify Test Results











Workflow process obtained from Carl R. Darnall Army Medical Center, Fort Hood, TX.



Interpret Results

Interpret Results

Record Results

Record Results

Electronic Data

Manual Step

Decision Point

Separate /

Sub-Process

Start / Stop




T

I

M

W

O

O

D


Immucor Echo – Workflow Analysis (Type & Screen Procedure)

Immucor Echo Testing Certifying TechReceiving Tech



ER?


Manual Testing

Yes


Uncap & Place

Specimen on Echo



Appropriate Tests


On Board?

Load other reagents &

supplies

No

Select “Start”


Find appropriate tests ordered

Enter Test ResultsFind Patient in Hospital LIS

Enter Test Results



Yes


- STOP


for Human Error


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




Immucor Echo – Workflow Analysis (Type & Screen Procedure)

Immucor Echo Testing Certifying TechReceiving Tech




ER?


ER?


Manual Testing


Manual Testing

Yes



Uncap & Place

Specimen on Echo

Uncap & Place

Specimen on Echo




Appropriate Tests


Appropriate Tests


On Board?


On Board?


supplies


supplies

No

Select “Start”Select “Start”





Enter Test ResultsEnter Test ResultsFind Patient in Hospital LIS

Find Patient in Hospital LIS






Yes


- STOP


- STOP


for Human Error


STOP


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




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



ER?No



Enter Test Results


Enter Test Results

Go To Manual Gel Testing Flowchart

No


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


Certify Results - STOP


Select appropriate tests

Uncap & Place Specimen on

ProVue


for Human ErrorWorkflow process obtained from William Beaumont Army Medical

Center, El Paso, TX.


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




Patient Identifiers


Patient Identifiers


ProVue?


ProVue?


onto ProVue


onto ProVue

Yes




ER?


ER?No











No


Manual Testing


Manual Testing

Yes



No

Yes


on Board?


on Board?Yes



No




Supplies


Supplies


Performance


Performance










ProVue


ProVue


for Human ErrorWorkflow process obtained from William Beaumont Army Medical




Separate ProcessSeparate Process



Value Added, Customer

willing to pay for

Workflow process obtained from William Beaumont Army Medical


T

I

M

W

O

O

D





(5 min)


(5 min)


ER?


ER?


Manual Testing


Manual Testing

Yes



Uncap & Place

Specimen on Tango

Uncap & Place

Specimen on Tango



Yes



No


On Board?


On Board?


supplies


supplies

No

Select “Start”Select “Start”







- STOP


- STOP

Yes


for Human Error


STOP


STOP



No


Appropriate Tests


Appropriate Tests




(5 min)


ER?


Manual Testing

Yes


Uncap & Place

Specimen on Tango


Yes


No


On Board?


supplies

No

Select “Start”


Enter Test Results



- STOP

Yes


for Human Error


STOP



No


Appropriate Tests

Measure – Tango Process Map

Electronic Data

Manual Step

Decision Point

Separate /

Sub-Process

Start / Stop




Documents

Workflow Analysis Using the LSS Roadmap; Comparing Five ...2F82162C-6430-4E94... · Bio-Rad Laboratories IMMUNOHEMATOLOGY Workflow Analysis Using the LSS Roadmap; Comparing Five Methodologies