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LEAN: DRIVING UP EFF ICIENCY AND QUALITY WHILE DRIVING DOWN  W ASTE AND COST  by  Ron Wince President and CEO, Guidon Performance Solutions LEAN LAB ASSESSMENT: CASE STUDY  by  Joseph Campos, Ph.D. Director, Microbiology Laboratory, Molecular Diagnostics Laboratory and Laboratory Informatics at Children’s National Medical Center, Washington, D.C. &

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8/6/2019 LeanLab Whitepaper

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LEAN: DRIVING UP EFFICIENCY AQUALITY WHILE DRIVING DOWN

WASTE AND COST

by Ron WincePresident and CEO, Guidon Performance Solutions

LEAN LAB ASSESSMENT: CASE STU by Joseph Campos, Ph.D.

Director, Microbiology Laboratory, Molecular Diagnostics Laboratory and LaboratoryInformatics at Children’s National Medical Center, Washington, D.C.

&

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Lean: Driving Up E fciency And Quality While DrivingDown Waste And CostBy: Ron Wince, President & CEO,Guidon Performance Solutions

In an already weakened economy, hospital-based microbiology laboratories are underincreased pressure to provide the highest quality patient test results. This pressure is dueto several actors, including same day test results demanded by physicians, an increasingnumber o test samples (legislation requiring HAI screening, increasing organismresistance, etc), additional testing menus based on new technologies (molecular testing),and limited laboratory budgets. Unlike other laboratory departments such as chemistry and hematology, the microbiology laboratories still rely on manual and subjectiveprocedures to per orm many o their routine tests. An estimated 40 - 50 percent o amicrobiologist’s current time is spent on administrative and other manual tasks wherethey use little i any o their technical expertise. The amount o time that laboratory technologists spend cycling paperwork, per orming unnecessary tests, or walking rombench to bench can be costly in terms o waste and money, with ine ciency as one o the largest drivers o waste.

Compounding the existing ine ciencies in microbiology laboratories is the strainon resources with respect to skilled technicians. The January 2008 issue o MedicalLaboratory Observer cites that or every seven clinical laboratory scientists that retire, only two new scientists are entering the eld o laboratory technology. According to the U.S.

Bureau o Labor Statistics, by 2014, approximately 81,000 technologists and technicians will be needed to ll spaces le t by retirees, with another 68,000 technologists neededto ll new positions as a result o increased testing volume and menu. ( ASCP, 2009 ) Inthe wake o increasing demands or patient care, the diminishing pool o well trained,experienced microbiologists is orcing many microbiology laboratories to reassess currentprocesses to manage their workload.

What is Lean?In 1989, the College o American Pathologists developed and implemented the rstnationwide quality assurance program or pathology and laboratory medicine. Leanensures that laboratories continue to meet strict regulatory issues without havingto compromise quality control, turnaround times, or per ormance. Lean eliminatesredundant procedures and motions by reorganizing the laboratory ootprint so that labpersonnel spend less time handling and processing specimens. It is not an endpoint;rather, it is a journey that relies on the ongoing relationship between management andthe laboratory sta to reduce ine ciencies while striving or the highest possible patientoutcomes. Lean helps laboratory workers and management nd better ways to increase

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productivity and e ciency without driving up costs and impeding workfow.bioMérieux has joined orces with Guidon Per ormance Solutions, a leader in LeanSix Sigma per ormance management consulting, to help microbiology laboratory leadership identi y waste and make recommendations or improving e ciencies, thus

improving sample turn-around time.

Waste is antithetical to e ciency. Waste inter eres with thought processes, it creates workfow dams that inter ere with laboratory personnel motion, it adds unnecessary time to procedures resulting in delayed turn-around times, it leads to higher errorrates, and it reduces e ciency and quality control. Lean is a philosophy that considers all “touches” in the workfow path. It is aboutgetting people to work together to reduce or eliminate waste. Lean, however, doesn’thappen in a vacuum. It involves listening to administrators and managers as well asthe individuals who process and handle specimens. O tentimes, it is the lowest personon the totem pole who o ers the greatest suggestions or removing waste.

The Lean perspective and the seven orms o waste were originally de ned by Toyota ® as part o their Toyota Production System (TPS) as an integrated socio-technicalsystem that comprises its management philosophy and practices. In a book authoredby James Womack and Daniel Jones, the name Tim Wood was coined by taking the

rst letter o each o the seven types o waste. This philosophy can also be applied tomicrobiology laboratories.

1. Transportation – re ers to the act o moving a patient specimen rom oneplace to another.

2. Inventory – re ers to anything in the queue; it could be specimens that arewaiting or processing or a surplus o supplies in inventory.

3. Motion – re ers to excessive movement caused by poor ergonomics such asworkplace layout.

4. Waiting – re ers to delays caused by instrument availability, instrumentdowntime, or waiting on the sample to be processed.

5. Overproducing – re ers to per orming work be ore it needs to be done, suchas collecting samples that aren’t needed, preparing batches o pre-process orms, or preparing samples that are not ready to be processed by the next instrument.

6. Overprocessing – re ers to double checking work or waiting or approvalrom lab management.

7. De ects/Rework– re ers to time spent correcting mistakes.

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Changing the Way Microbiology Laboratories Conduct BusinessAt least 50 percent o what happens in microbiology laboratories is waste. Thisincludes unnecessary breaks in workfow – rom receipt o patient sample to

administrative ollow-up. Activities that are deemed essential, or value-added, mustmeet all o the ollowing three criteria:

• The activity must be done right the rst time.• The activity must transform the request, i.e., moving the samples to transform

into a result that is provided to the physician.• The activity must conform to the original request only, i.e., perform only thosactivities that were requested.

Lean helps microbiology laboratory personnel increase e ciency without having to work aster or harder. Lean is about learning ways to improve e ciency by working ina di erent way. It takes an end-to-end approach or identi ying problems in the valuestream or value chain that lead to breakdowns in e ciency – “doing the right thing”and e ectiveness – “doing things right”.

Lean teaches laboratory managers how to identi y areas that negatively a ect workfow by helping them recognize waste. Guidon’s unique partnership withbioMérieux helps microbiology laboratories identi y breakdown points or waste thatresult in non-value-added activities, such as samples sitting in queue, barricades totra c fow, or time wasted waiting on instrument availability. By identi ying where

waste occurs, laboratory managers can work toward eliminating waste, thereby increasing e ciency and e ectiveness anywhere rom 10-40 percent, and can reducede ects as much as 80 - 90 percent.

Out With the Old, In With the New Many hospital-based microbiology laboratories do not have the budget to replaceold equipment or manual procedures, regardless o their ine ciency or high cost.Other laboratories adopt the “i it’s not broke don’t x it” philosophy. All too o ten,laboratories ollow antiquated routines just because “they work,” despite theine ciencies, increasing cost, and potential risk o errors.

This mindset reminds me o a story I was told about the mother who cuts o theends o a ham be ore placing it in the oven. One day, her daughter asks her, “Why do you cut o the ends o the ham?” Her mother responds, “because that is how my mother did it when I was a young girl.” Not to be deterred, the young girl asks her

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Figure 1 ). The Guidon/bioMérieux team meets with laboratory managers and sta to discuss their ndings and identi y waste – most importantly they determine whatsteps to take to eliminate or reduce it.

Figure 1: Spaghetti Diagram

The Lean Lab Design phase starts with a kick-o meeting with the key laboratory stakeholders. During this meeting, laboratory management discusses current workfowprocesses, division o labor, and key areas on which to ocus the evaluation. A terobserving the laboratory at di erent times o the day, and across di erent shi ts,the Guidon/bioMérieux team analyzes the ndings and develops a nal report

or the laboratory. This report includes analysis o motion studies, cycle time data,administrative workfow, existing in ormation systems, quality issues, and specimenfow patterns. This analysis concludes with a roadmap outlining how the lab canimprove e ciencies and sample turn-around times. This roadmap includes actionsthat can be taken, their impact, and next steps or implementing the actions. Theserecommendations are typically categorized into one o three areas: laboratory layout, sample volume/sta optimization, or areas where automation will increasee ciencies.

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Red uce u nnece ssa ry p roces s st ep s, test s an d d uplicat ion

Iden tify u nnec es sa ry p roce ss st ep s, tes ts a ndduplicati on

Iden tify va riab ility, err or prone st ep s an d man ualtran sc ription in the proce ss

Iden tify va riab ility i n proce ss es from Te ch to Te ch ,Shift to Shift

Iden tify b ottle n ec ks an d del ay s i n the proce ss

Stan dardizeProcesse

Impr ove T AT

Over product ion

Red uce E rrors

Maxi mizeAutomat ion

Automation o tentimes can reduce the overall ootprint o the laboratory, thereby reducing the laboratory’s overhead cost. It can help reduce bottlenecks in workfow,thereby increasing productivity, reducing turn-around times, and reeing up time ormore experienced laboratory sta to per orm value-added activities ( see Figure 2 ).Something as simple as reorganizing workfow can have dramatic e ects on time andmotion analysis.

Figure 2: Automation Reduces Variability and Increases Quality o Test R

Winston Churchill said, “There is nothing wrong with change, i it is in the rightdirection.” Lean strategies and tools help laboratories move in the right direction.

The best way to e ect change is to include all laboratory personnel rom managementto bench technicians in the assessment process. Not only does this alleviate stressamong the laboratory workers, but it also helps the workfow analysis team quickly discover where the skeletons are hidden.

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LEAN: DRIVING UP EFFICIENCY AND QUALITY WHILE DRIVING DOWN WA

We don’t have to wait to discover the things that drive technologists and administratorscrazy. Because o the involvement o the multi-disciplinary group, they already knowtheir points o pain. The assessment can piggyback on what the lab sta already knowsand take it to the next level. Another advantage o this all-inclusive approach is thesuccess in changing the attitude o the most vocal opponents o Lean, the so-calledCAVE dwellers (citizens against virtually everything) into some o the most outspokenadvocates o Lean. The group becomes Lean-thinkers by the very nature o thediscussion. We typically nd that laboratories that adopt Lean see a ve-time return oninvestment. Lean laboratories consistently deliver high quality results with aster turn-around times and lower costs to the physician and patient. That means physicians canstart treatments earlier so that patients can vacate hospital beds and go home sooner.

Conclusion

In the current healthcare environment, the microbiology laboratory is aced withunprecedented challenges. The need to address mounting pressures due to multi-drug resistant organisms and a growing list o superbugs in the ace o a dwindlingpopulation o skilled microbiologists places urther burden on the laboratory workload.In order to answer to physicians’ requests or rapid, reliable results, laboratories andtheir sta are turning to lean alternatives to reduce waste, speed the time o results tophysicians, and enhance the quality o the in ormation they provide. With the potential

or increasing e ciency and e ectiveness anywhere rom 10 - 40 percent, coupled witha reduction o de ects as much as 80 - 90 percent, can your laboratory a ord not to beLean?

Re erences Amirahmadi, Fazi, Al Dalbello, Dan Gronseth, and Jean McCarthy. “Innovations in the Clinical Laboratory: An O Lean Principles in the Laboratory.” (2007): 2. Mayo Medical Laboratories. Aug. 2007. Web. 28 Oct. 2009.

Critical Values: News or the Entire Laboratory Team. American Society o Clinical Pathology. 2008: 1(4). Deckard GJ, Borkowski N, Diaz D, Sanchez C, Boisette SA. Improving timeliness and e ciency in the re erral p sa ety net providers: application o the Lean Six Sigma methodology. J Ambul Care Manage. 2010.;33(2):124-30

Wince, R. Personal Communication. Lean Assessments in Healthcare Systems. April 6, 2010. Available at: http://w guidonps.com/industry-expertise/ideas-and-resources/multimedia/lean-six-sigma-podcasts.

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Lean Lab Assessment: Case StudyBy: Joseph Campos, Ph.D.,Director, Microbiology Laboratory, Molecular Diagnostics Laboratory andLaboratory Informatics, Children’s National Medical Center, Washington, D.C.

In the same way a community depends on its hospital, the hospital depends on theclinical laboratory. The lab is the lynchpin or nearly every treatment decision withinthe hospital. Each step along the continuum o care – patient admission, diagnosis,treatment, patient discharge – requires data provided by the clinical lab. There ore, thespeed and accuracy with which results are provided is critically important to the well-being o our patients. As director o the Microbiology and Molecular Diagnostics laboratories and Laboratory In ormatics at Children’s National, my role is to ensure our laboratory delivers e cientand accurate results that are cost e ective. In addition, we also strive to adopt new teststhat provide better clinical in ormation. All must be done, at a time when there is ashortage o skilled clinical laboratory scientists.

I am very proud o our microbiology laboratory and sta and eel that we have provento be a critical member o the patient care team. Nonetheless, as highly regarded as alaboratory might be, we are always looking or ways to improve. Operational e ciency can always be enhanced and the clinical utility o test results can always be made better.In addition, our expanding workload has been outstripping the size o our laboratory

sta .

Over the years, I’ve witnessed Lean process improvement e orts that were conductedin other laboratories. I have heard some state that Lean principles are better suited

or automated chemistry and hematology laboratories than they are or microbiology laboratories. I knew that Lean had helped many organizations extract waste rom theirprocesses, improving speed, e ciency and quality. Contrary to what others might havethought, I was con dent it could do the same or our microbiology laboratory.

In many ways, a microbiology laboratory is similar to any other enterprise that workson the in/out principle (e.g., the post o ce, global shipping companies, automobilemanu acturers and supermarkets). For the lab, specimens come in one end, test resultsgo out the other end and elimination o waste in between leads to more time beingspent on value-added activities.

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About Children’s National Medical CenterChildren’s National Medical Center is the only exclusive provider o pediatric care in themetropolitan Washington, D.C. area. Nationally recognized as one o the best pediatric

hospitals in America by U.S. News & World Report and the Leap rog Group, Children’sNational has been serving the nation’s children or more than 135 years and is a provenleader in the development and application o innovative new treatments or childhoodillness and injury. The hospital cares or more than 360,000 patients each year whocome rom throughout the region, the nation and the world. Serving as an advocate orall youth, Children’s National is the largest non-governmental source o pediatric care inthe District o Columbia, providing more than $50 million in uncompensated care each

year. In addition, Children’s National serves as the regional re erral center or pediatricemergency, trauma, cancer, cardiac and critical care as well as neonatology, orthopaedicsurgery, neurology and neurosurgery.

Putting Ourselves Under the MicroscopePrior to beginning the actual Lean Lab design workfow optimization service,bioMérieux spent a day in our laboratory, gathering data or use in the workfowanalysis. These data included sample volumes, time o day samples were received, turnaround time or test results and sta ng schedules.

The bioMérieux/Guidon team pre ers to be given a calendar year’s worth o laboratory data, which is sensible considering the seasonality o many in ectious diseases. While

a ew weeks or months provide a snapshot o the workfow, 12 months are betterbecause o the marked e ect that the change o seasons has on the workload in ourlab. Our workload ebbs and fows throughout the year due to weather fuctuations,school schedules, community outbreaks, etc.

The bioMérieux/Guidon Lean Lab Design workfow optimization service commenced with a kick-o meeting attended by key laboratory personnel. During the introductory meeting, the Lean Lab team rom bioMérieux/Guidon described their process sothat lab personnel would know what to expect the rest o the week. Additionally, labpersonnel identi ed key areas where they elt process improvements would have thegreatest impact.

Over the course o three and a hal days, three Lean Lab assessment team membersobserved how samples were processed in the microbiology lab. This observation

was done in a way that did not impede our workfow because it was conductedby individuals who understood microbiology testing. The team came to me or the

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laboratory supervisor periodically or validation o ndings or to clari y observations. They also requested data rom the recent past, regarding specimen arrival dates andtimes, culture result turn-around times, sta ng patterns, etc.

Specimen Drop-o : E fciency Starts at ReceivingDuring peak hours, specimen accessioning and processing at any large microbiology labcan seem like controlled chaos. But, there is a method to the madness. Specimens aredropped o , sorted, bar-code labeled, received into the laboratory in ormation system(LIS) and processed. Processing can include centri uging, pouring o supernatants,aliquotting, grinding tissue and other steps necessary or the preparation o smears andthe inoculation o cultures.

The Lean Lab assessment team recommended that we improve our process o specimen accessioning by creating a “work cell” dedicated to the complex and iterativeprocess o handling specimens. At the time o the assessment, our lab’s accessioningarea was a pass-through area located in the Core laboratory, away rom the rest o the microbiology laboratory. People walked through it because it was an aisle in thelaboratory that led to other work areas. The assessment team recommended that werelocate the accessioning area to a “work cell” in the main microbiology laboratory

where specimens would be delivered to a dedicated accessioner to eliminate specimenbacklogs and decongest this vital space and unction.

By making the accessioning area a dedicated “work cell”, we will increase e ciency by ensuring STAT specimens receive top priority, while other specimens will be processedin the order they are dropped o . Under the previous system, some microbiology specimens remained in the general laboratory accessioning area while STAT chemistry and hematology specimens were processed rst.

Tracking SamplesWithin a day o the observation period, the bioMérieux/Guidon team had preparedan assessment presentation and an evaluation. We all gathered to listen to theirrecommendations and to brainstorm solutions to help us improve our processes. Frommy perspective, this was one o the most positive parts o the experience.One o the most eye-opening parts o the presentation was the “spaghetti diagram”analysis, ( See Figure 1 ) which tracked the movement o technologists and specimens

within the laboratory over a brie period o time.

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You just don’t realize how extensively people move around a laboratory in the courseo a regular work day and how much time they spend getting rom point A to point B.Our “spaghetti diagrams” showed that we had an opportunity to decrease wasted timethrough a more e cient organization o the lab. One trip here that takes 30 secondsand another trip there that takes 45 seconds, adds up quickly to a signi cant sum. Inthe nal analysis, we learned our technologists were actually walking great distances

or long periods o time.

Another tool used by the laboratory assessment team was a Pareto diagram, whichshowed the time o day specimens arrive in the laboratory versus the sta ng level ( SeeFigure 2 ). It actually surprised me to learn how many o our specimens arrived duringthe third shi t, between 11:30 p.m. and 7:30 a.m. Approximately 20-25 percent o our

workload was collected during this shi t rom patients in the emergency departmentand in the in-patient units. As the gure shows, this was at a time when the laboratory

Figure 1: Spaghetti Diagram o Current Workfow

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had limited sta to process specimens other than CSF and STAT antigen detectionrequests.

Figure 2: Analysis o Sta ng and Specimen Vo

Current StateI suspect that the workfow and sta ng patterns described above are similar tothose in many other microbiology labs across the U.S. The day shi t arrives andgathers the culture plates that have incubated overnight and begins the readingprocess. There’s either growth or no growth and urther work is per ormedaccordingly. Culture plates showing no growth on the rst reading are re-incubatedand read again the ollowing morning.

However, a culture that is inoculated in the evening – let’s say at 10 p.m. – andthen examined at 8 a.m. has incubated or only 10 hours. In most laboratories suchcultures would be re-incubated or 24 hours be ore the next examination. Many clinically signi cant organisms cannot orm visible colonies in just 10 hours; whereas,they likely will orm visible colonies in 16-18 hours. This single morning plate reading

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per day has a major delaying impact on the overall turn around time or specimenresults to our physicians ( See Figure 3 )

Figure 3: Positive Culture Turnaround Tim

Future State

Because the Pareto analysis showed that the number o people available to handle our workload was out o synch with the arrival time o our specimens, we have decided toadjust our sta ng patterns in an appropriate ashion. Presently, the microbiology laboratory is sta ed or the rst and second shi ts, but notthe third shi t. Specimens other than CSF and STAT antigen detection requests thatarrive during the third shi t are re rigerated until the ollowing morning. Thus, there isan inherent, 1-8 hour lag in the processing and culturing o those specimens simply because they arrive during the third shi t.

Planning to eliminate this delay required a care ul examination o our sta ng patterns.We are planning to allocate two technologists each to the second and third shi ts,leaving our remaining seven technologists or rst shi t responsibilities and lling

vacancies due to sickness, vacations and time o or weekend/holiday work. New

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80%

70%

60%

50%

40%

30%

20%

10%

0%1 2 3 4 5 6 7 8 9 10

Blood Urine Misc Resp

Posit ive TAT ( Days)

Blood

2 3 4+

8%

72 %

43%

16% 26% 57%

34% 23%

47 %

23% 6%

45%

Urine

Misc

Resp

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cultures will be inoculated as specimens arrive and will be placed in the incubatorsaccording to the time o inoculation. All newly inoculated cultures will be examined

or the rst time a ter 16-18 hours o incubation and identi cation/antimicrobialsusceptibility tests set up as appropriate.

Setting up and reading cultures around the clock will shorten the turnaround timeor most cultures in dramatic ashion. These changes will also ensure that specimen

integrity is maintained, since delays in specimen processing will be kept to a minimum.Processing better specimens up ront will mean a higher quality o test results will bedelivered.

ConclusionLaboratory scientists are, by nature, observational and analytical – they watch and

analyze. So, there was some irony when we put ourselves under the bioMérieux/Guidonmicroscope or three and a hal days.

Additionally, there’s an understandable tendency or people at the workplace to beear ul and suspicious when a group o strangers comes into a laboratory with pencils

and clipboards. One o my responsibilities was to reassure the sta that our goal was toimprove the quality o our laboratory service – not eliminate positions.

As our lab sta became accustomed to the presence o the Lab Assessment team,they became involved in the process, and soon realized that this Lean lab assessment

wasn’t something to be worried about, but rather it was something to be welcomed. I’mortunate that our laboratory sta and I share one common goal that steers us all in the

same direction: the well-being o our patients.

What we saw during and a ter the assessment was an evolution o thought among thetechnologists because they were part o the process and part o the desire to providebetter service to our physicians and to our patients. We have the tools we need toinitiate change and with the assistance o bioMérieux and Guidon, we believe that

we will continue to make our laboratory better and more e cient… or us and or thepatients we serve.

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