A LEAN SIX SIGMA APPROACH TO CONTINUOUS QUALITY ... · A LEAN SIX SIGMA APPROACH TO CONTINUOUS QUALITY IMPROVEMENT IN THE TEXAS NEWBORN SCREENING PROGRAM PATRICIA HUNT V. Telles,

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 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

METHODOLOGY

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

1.93

1.44 1.43 1.37 1.32

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

Biotinidase SCID T4 HGB DNA CAH IRT GALT MS

Day

s

Avg TATs By Area

avg

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

Congenital Hypothyroidism

Galactosemia

Tandem Mass Spectrometry

PROJECT SELECTION

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

CHECK-IN

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

Computer30

Book Case

6 24

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

Spaghetti Diagram

`s

42

27

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

improvement

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%.

GALACTOSEMIA

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.

GALACTOSEMIA

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

LIMS

InstrumentRaw Results

Processed Results

Results to 2nd

Review

Data Validation Complete

Retest list is generated

InstrumentRaw Results from Retest Processed

Retest Results

PunchingClinical Care

Fax with Patient Identifying

information along with Abnormal Test

Results/ Possible Phone Call

Data Entry

DemographicInfo (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 forfinal reportReporting

Data Released to Reporting

IAbnormal

Report

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.

FIFOFIFO

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!

RESULTS

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.

LESSON LEARNED