A LEAN SIX SIGMA APPROACH TO CONTINUOUS QUALITY
IMPROVEMENT IN THE TEXAS NEWBORN SCREENING
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 SymposiumMarch 3, 2016
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.
OVERVIEW OF CQI PROJECTS AT DSHS
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
THE APPROACH - DMAIC
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
ESTABLISHING A BASELINE
30,000 FOOT ASSESSMENT OF THE DSHS NBS LAB
2.66 2.61 2.53 2.48
1.44 1.43 1.37 1.32
Biotinidase SCID T4 HGB DNA CAH IRT GALT MS
Avg TATs By Area
Error Bars Illustrate One Standard Deviation Above and Below the Averages
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
Tandem Mass Spectrometry
Green belt: Tif funee Odoms
Goal: Initial: To reduce the amount of time specimens spend in the check-
in and punching 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:RecycleBin Pole Computer Recycle
Amanda's Office Vacant Office Break Area Bin
Copier 20 37 Table Stampers18 18 Bundle Station
31 StampersComputer 12 16 22 7 11 17 1 9
5 14 3 17 7 13 3 11 33 24 Post rip16 39 15 20 25 27 29 10
38 35 Workstation 2 Stampers19 33
19 36 34 39 18 20 27 26 7 27 8 Stampers21 5 6 8 8 40 6 42 4 26 28 25 28 12 24 41 3717 4 10 A J 7 T 5 3 9 16 29
Computer Bundles to check Stampers15 13 25 6
P 23 19 5 21 Stampers2 433 32 38 14 34
Work Station Stampers14 21
Computer 29 30 Stampers36 S 4
Decision Unsat Extra Extra RR/Yellow Sticky 10Forms Newborn Follow Reaccessioned Stampers
Forms Up's UnsatsUnsat H Stampers
2 1527 28 9 8 29 24
9 13 30 22 22 40 10 11 31 42 32Label Prnter 12 26 1 23 41 23 14 1
SinkDoor Door Computer Computer
PKU Monitoring 39Globals Phone
CHECK-IN SPAGHETTI DIAGRAM
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.
CHECK-IN PROJECT UPDATE
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
CONGENITAL HYPOTHYROIDISM (T4)
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.
TANDEM MASS SPECTROMETRY
Add Controls Internal Standard addition/ extraction
Incubate 45 minutes
Plate Foiled2 Hour
IncubationSample analysisat instrument
1st QC 2nd QC Retests are Punched
Samples Prepared (Same
as steps 1-5
Restest Assay Run
Retest Assay Reviewed and
final resultdeterminationI I I I I I I I I I I I
Results to 2nd
Data Validation Complete
Retest list is generated
InstrumentRaw Results from Retest Processed
Fax with Patient Identifying
information along with Abnormal Test
Results/ Possible Phone Call
DemographicInfo (Birth weight) Via
Current State Value Stream Map: Tandem MS Abnormals
FIFO FIFO FIFO FIFO FIFO
Plate Plate Plate Plate Plate Data Data Retest List
Plate Plate Plate
Data Released forfinal reportReporting
Data Released to Reporting
1 micro titer plate = 1 bundle plus QCs1 bundle = 88 samples1 chunk of data is the data for all 88 samples and QCs on a plate.
Attribute data will be recorded for each step in the spaces provided below that step. Attribute data has not yet been aquired.
MS/MS VALUE STREAM MAPPING
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.
TANDEM MASS SPECTROMETRY
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!
Lean Six Sigma approach is suitable for the NBS process to identify bottlenecks and improvement opportunities.
Data is important. Some data isn’t captured in LIMS (ie. Preliminary Result Reporting).
Managerial support and guidance is essential –Establish a QI Advisory Committee
Require resources, time, and collaboration –Persistence is a must!
Communicate with staff early and often. Sequential projects, not in parallel. Focus one at a
time. Not all recommendations are feasible.