A LEAN SIX SIGMA APPROACH
TO CONTINUOUS QUALITY
IMPROVEMENT IN THE TEXAS
NEWBORN SCREENING
PROGRAM
PATRICIA HUNT
V. Telles, T. Odoms, P. Trevino Gonzales, A. Vinyard, L. Cao, S. Tupy, B. Reilly, P. Hunt, R. Lee Texas Department of State Health Services, Austin, TX
2016 APHL Newborn Screening and Genetic Testing Symposium
Lean Six Sigma process in DSHS Laboratory started with
Yellow Belt Training (40 staff). Continued with Green Belt (8 staff) and Black Belt Training (4 staff). Currently includes a new level provided in-house, White Belt Training.
Led to:
Black Belt Project – Improve Space Utilization in the Laboratory –
may impact NBS Molecular Testing.
Yellow Belt Projects – 5S each testing area in NBS – basically clean
up, get rid of obsolete consumables.
Green Belt Projects – Improve NBS Turn Around Times.
Green Belt Project – (Ch-IP) Improve time from NBS specimen
accessioning (Check-In) to punching.
See Poster #33 presented by Brendan Reilly.
Lean Six Sigma
Managerial approach
Combines Six Sigma methods and tools and the lean
manufacturing/lean enterprise philosophy
Eliminate waste of physical resources, time, effort and talent
Assure quality in production and organizational processes
The Theory of Constraints
Methodology used in Lean Six Sigma
Identify the most important limiting factor (i.e. constraint) that
stands in the way of achieving a goal
Systematically improve that constraint until it is no longer the
limiting factor
In manufacturing, the constraint is often referred to as a bottleneck
Define – define the problem and the project goals
Measure – identify the baseline and key metrics
Analyze – the data and the processes
Improve – implement improvements
Control – maintain and sustain the improvements
Lean Six Sigma and Theory of Constraints concepts were used to
analyze the system timeliness and efficiency in the Texas Newborn Screening (NBS) Laboratory
The Lean Six Sigma Green Belt Team
4 Individuals working on Lean Six Sigma Green Belt certification
Assistance from a Yellow Belt
Goals:
Examine processes from the arrival of specimens in the laboratory to the
final reporting step in an effort to remove delays, duplications and bottlenecks.
Improve the average overall NBS turn-around-time by 10%, from 5.26
days to 4.73 days, in a way that prioritized the turn-around-time of abnormal results for the most crucial NBS tests.
OVERVIEW OF THE GREEN BELT
PROJECTS
Data collection
Forms were created for each area to capture major time points in the
process
3 bundles/day over a period of 2 weeks
Data collected was compared to the LIMS data
Data Analysis
Overall TAT is meeting established expectations.
The current process flow appears predictable and stable.
Based on data analysis, initiated a series of projects to
minimize the time from receipt of the specimen to:
Release of presumptive positive results for critical disorders
Release of presumptive positive results for non-critical disorders
Reporting of complete test result
30,000 FOOT ASSESSMENT OF THE
DSHS NBS
LAB
2.66 2.61 2.53 2.48 1.93 1.44 1.43 1.37 1.32 0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00Biotinidase SCID T4 HGB DNA CAH IRT GALT MS
D
ays
Avg TATs By Area
avg
Based on results from data analysis and criticality of
disorders, 5 projects were selected:
Check in (Specimen Receiving/Accessioning) and Punching
Data Entry and Logistics –plan to reassign and reinitiate in
near future
Congenital Hypothyroidism
Galactosemia
Tandem Mass Spectrometry
Green belt: Tiffunee Odoms
Goal:
Initial: To reduce the amount of time specimens spend in the
check-in and punchcheck-ing areas.
Final: To reduce the amount of time specimens spend in the check-in
area.
Analysis of punching process moved to a new Green Belt Project – Ch-IP (see poster #33)
Reviewed processes and Standard Operating Procedures
(SOPs) for the area
Evaluate process flow using spaghetti diagram and a modified
value stream map
Area: NBS Check-In Process: Work Flow Distance:
Recycle
Bin Pole Computer Recycle
Amanda's Office Vacant Office Break Area Bin
Copier 20 37 Table Stampers
18 18 Bundle Station 31 Stampers Computer 12 16 22 711 17 1 9 5 14 3 17 7 13 3 11 33 24 Post rip 16 39 15 20 25 27 29 10 38 35 Workstation 2 Stampers 19 33 19 36 34 39 18 20 27 26 7 27 8Stampers 21 5 68 8 40 6 42 4 26 28 25 28 12 24 41 37 17 4 10 A J 7 T 5 3 9 16 29
Computer Bundles to check Stampers
15 13 25 6
P 23 19 5 21 Stampers
2 43
3 32 38 1
4 34
Work Station Stampers
14 21
Computer 29 30 Stampers
36 S 4
Decision Unsat Extra Extra RR/Yellow Sticky 10
Forms Newborn Follow Reaccessioned Stampers
Forms Up's Unsats
Unsat H Stampers Computer 30 Book Case 6 24 2 15 27 28 9 8 29 24 9 13 30 22 22 40 10 11 31 42 32 Label Prnter 12 26 1 23 41 23 14 1 Sink
Door Door Computer Computer
PKU Monitoring 39 Globals Phone Spaghetti Diagram `s 42 27
After Measure and Analysis step, recommendation was to
adjust to a ‘1 to 1’ or continuous flow process.
Check-in Group implemented the new ‘1 to 1’ process in the
Improve phase.
This allows bundles of specimens to be available for testing
throughout the day rather than previous goal of all bundles available by 5 pm daily.
Allowed the testing areas to model some new punching
workflows during 2015 Christmas Holiday for Ch-IP project.
Green belt: Linda Cao
Goal:
Reduce turn around time with a focus on abnormal results
A workflow diagram of the current process was created, also
utilized SIPOC, Fish Diagram, Spaghetti Diagram, and Value Stream Mapping.
Met with team members to get input on process change ideas
Currently evaluating SOPs to focus on best areas for
improvement
Green belt: Shawn Tupy
Goal:
Reduce the TAT notification for abnormal results
Measured the current process and theorized the impact if the
process were changed from reporting preliminary results on Friday to reporting preliminary results daily.
Pulled reporting data for abnormal test results.
Average turn around time (TAT) in a 15-month period from
initial abnormal result to notification of Clinical Care
Coordination (CCC) is 35 hours and 21 minutes. Goal is to improve TAT by at least 10%.
Results of Analysis Phase
17 results met preliminary reporting criteria.
7 samples confirmed with abnormal results
5 samples were borderline abnormal
4 samples were normal
1 sample recovered inconsistent results
Improvement phase recommendation: Notify CCC of abnormal
results based upon initial testing results (i.e. a preliminary report).
4 out of 17 patients would receive unnecessary treatment for up to 48
hours until the repeat testing is complete.
12 out of 13 patients with abnormal or borderline results could be
started on treatment the same day as the initial abnormal result was obtained.
Improvement Phase Final Outcome
Input from Clinical Care Coordination – prefer to minimize parental
anxiety by not increasing the amount of preliminary reports.
Green belt: Andrew Vinyard
Goal:
Reduce TAT for abnormal specimens with an impact on the process
as a whole to ensure the overall goal is accomplished
Collected baseline metrics for the area for Measure Phase,
completed value stream mapping, held meeting with MS/MS staff for ideas for more effective process, held Wisdom of the Org meeting with team leads and supervisor.
Add Controls Standard Internal addition/ extraction
Incubate 45
minutes Plate Foiled
2 Hour
Incubation Sample analysisat instrument 1st QC 2nd QC
Retests are
Punched Prepared (Same Samples as steps 1-5
Restest Assay
Run Reviewed and Retest Assay final result determination I I I I I I I I I I I I LIMS Instrument Raw Results Processed Results Results to 2nd Review Data Validation Complete Retest list is generated Instrument Raw Results
from Retest Processed Retest Results
Punching Clinical Care
Fax with Patient Identifying information along with Abnormal Test Results/ Possible Phone Call Data Entry Demographic Info (Birth weight) Via LIMS
Current State Value Stream Map: Tandem MS Abnormals
Physical Pull
FIFO FIFO FIFO FIFO FIFO
Plate Plate Plate Plate Plate Data Data Retest
List Plate Plate Plate
Reporting Data Released for final report Reporting Data Released to Reporting I Abnormal Report
1 micro titer plate = 1 bundle plus QCs 1 bundle = 88 samples
1 chunk of data is the data for all 88 samples and QCs on a plate.
FIFO FIFO
Attribute data will be recorded for each step in the spaces provided below that step. Attribute data has not yet been aquired.
During Measure phase, the MS/MS abnormals had a
turn-around-time of 1.19 days after punching step, hoped to improve turn-around-time to 1.07 days (10% improvement).
After Analysis phase:
Some recommendation included: modifying the FDA approved
kit to shorten incubation step, working on Sunday, adjusting staff schedules to add an evening or late shift to lab.
Recommendation selected: Automate 1st Worklist steps.
Currently process is very manual and involves handwriting final results
Next step is Improve phase.
Developed new report in LIMS to replace manual record.
Working on updating the SOP.
The baseline data indicated that overall turnaround time met
DSHS previously established expectations and process flow appeared predictable and stable.
Check-in project near completion, the impact of the
improvement has been positive and will help prepare the laboratory for the next phase – Ch-IP project.
MS/MS project recommendation, although not implemented,
is expected to positively impact Texas’s ability to meet timeliness measures.
Overall improvement data will not be available until all
projects are completed.
These project will help DSHS meet timeliness measures in
future!
