J Med Biochem 2021; 40 (1) DOI: 10.5937/jomb0-26055

UDK 577.1 : 61 ISSN 1452-8258

J Med Biochem 40: 26 –32, 2021 Original paperOriginalni nau~ni rad

WORKFLOW OPTIMIZATION IN A CLINICAL LABORATORY USING LEAN MANAGEMENT PRINCIPLES IN THE PRE-ANALYTICAL PHASE

OPTIMIZACIJA PRIMENE PRINCIPA LEAN UPRAVLJANJA U KLINI^KIM LABORATORIJAMA U PRE-ANALITI^KOJ FAZI

Pablo Letelier1, Neftalí Guzmán1, Gustavo Medina1, Luis Calcumil1, Pamela Huencho1, Jonathan Mora1, Francisco Quiñones2, Jorge Jara2, Cristóbal Reyno3, Jorge G. Farías4,

Lisandra Herrera Belén4, Priscilla Brebi5, Ismael Riquelme6, Andrés San Martín2

1Precision Health Research Laboratory, Departamento de Procesos Diagnósticos y Evaluación, Facultad de Ciencias de la Salud, Universidad Católica de Temuco

2Clinical Laboratory, Hospital Dr. Hernán Henríquez Aravena, Temuco, Chile3Scientific and Technological Bio-resource Nucleus, Genomic Unit, Universidad de La Frontera

4Department of Chemical Engineering, Faculty of Engineering and Science, Universidad de La Frontera, Temuco, Chile

5Laboratory of Integrative Biology (LIBi), Center for Excellence in Translational Medicine (CEMT)-Scientific and Technological Bioresource Nucleus (BIOREN), Universidad de La Frontera, Temuco, Chile

6Instituto de Ciencias Biomédicas, Facultad de Ciencias de la Salud, Universidad Autónoma de Chile, Chile

Address for correspondence:Pablo Letelier, PhD,Precision Health Research Laboratory, Departamento de Procesos Diagnósticos y Evaluación,Facultad de Ciencias de la Salud, Universidad Católica de Temuco, Chile +56452205582e-mail: pletelierªuct.cl

Summary Background: The application of the Lean methodology inclinical laboratories can improve workflow and user satis-faction through the efficient delivery of analytical results.The purpose of this study was to optimise delivery times ofthe test results at a clinical laboratory, using Lean manage-ment principles in the pre-analytical phase.Methods: A prospective study with a quasi-experimentaldesign was implemented. Staff functions were restructuredand sample flows were modified. Delivery times of clinicalresults (glucose and haematocrit; 6648 data) from theMedicine and Adult Emergency services for years 2017and 2018 were compared.Results: A reduction (p < 0.05) in turnaround times in thedelivery of glucose test results at the adult emergency ser-vice was observed (84 to 73 min, 13%, pre and post). Inaddition, there was a non-significant reduction in the

Kratak sadr`ajUvod: Primena Lean metodologije u klini~kim laboratorijamamo`e da pobolj{a protok i funkcionisanje efikasnosti labora-torije u svrhu dobijanja analiti~kih rezultata. Svrha ovogprou~avanja je da se se optimizuje vreme isporuke rezultataispitivanja u klini~koj laboratoriji primenom principa Lean-menad`menta u pre-analiti~koj fazi.Metode: Primenjena je prospektivna studija kvazi-eksperi-mentalnog modela. Funkcionisanje osoblja je prilago|eno ipojednostavljen je protok uzoraka. Vreme isporuke klini~kihrezultata (glukoze i hematokrita) iz Klini~kog i Urgentnogodeljenja za odrasle u periodu od 2017 do 2018.Rezultati: Na|eno je smanjenje (p < 0,05) obrtnog vreme-na pri isporuci rezultata za glukozu u odeljenje urgentneslu`be (84 do 73 min, 13%, pre i post). Dodatno nije bilozna~ajnog smanjenja obrtnog vremena za izdavanje rezultataza glukozu i hematokrit za klini~ko odeljenje. U analiti~koj i

List of abbreviations: LIS, Laboratory Information System; MT,medical technologist; PMT, and seven paramedic techni-cians; ICU, ITU, critical patient care unit; TT, turnaroundtimes; M, medicine services; AES, adult emergency services;R-D, Reception-distribution of samples; D-S, Distribution-sec-tion; S-R, Section-result; R-V, Result-validation.

J Med Biochem 2021; 40 (1) 27

Introduction

A clinical laboratory is a fundamental unit in thesupport of diagnostic, prognostic, treatment controland prevention of different human pathologies. Itsmain role is to produce reliable, reproducible andtimely results to assist in the making of clinical deci-sions (1). Its operation requires maintaining an effi-cient and coordinated workflow with other services,under a strict system that will ensure the quality of itsresults in the pre-analytical, analytical and post-ana-lytical phases (2).

At present efficiency has improved and errorratios have decreased, both in the analytical and post-analytical phases, as a result of the standardisation ofin vitro methodologies, advances in instrumentation,availability of qualified staff and the implementationof laboratory information systems (3), ensuring trace-ability of the clinical samples and providing valuablemanagement information in support of continuousimprovement (4). However, the pre-analytical phase isassociated with a greater number of errors (5, 6),constituting one of the most complex phases to con-trol because it has a series of variables and severalcritical points that require improvement (biological,environmental, and technical factors) (7).This phasecan be divided into an extra-laboratory stage (analysisordering, patient preparation, specimen collection,transport and temporary storage) (6) and an intra-lab-oratory stage (reception, admittance and labelling ofsamples, centrifugation, distribution and preparing-aliquoting specimens for analysis) (7, 8).

Lean is a management model derived from theToyota Production System, first implemented at theToyota Japanese car factory (9, 10), which empha-sizes the elimination of waste and non-value-addedsteps in a setting of limited resources, maintainingpatient satisfaction (11). The pillars of this model arecontinuous improvement and respect of individuals,and its work philosophy aims at using human staffand available resources to improve user services. Theavailable evidence supports the idea that the applica-tion of the Lean methodology in health institutions

and particularly in clinical laboratories can improveworkflow and performance (12–15). With regard toimprovement models incorporated into the pre-ana-lytical phase, there is currently scant evidence to sup-port that the models have had much impact on thereduction of turnaround times in the delivery of clini-cal test results.

The goals of the project were to improveturnaround times (TT) of laboratory results, maximiseworkflow and eliminate waste, incorporating someprinciples of the Lean management model in the pre-analytical phase of a clinical laboratory. Beforeimproving the process, we also made sure that otherservices and units were informed and available tohelp with changes in workflow.

Materials and Methods

Study design

This study was a prospective, before-after analy-sis of process improvements in the clinical laboratoryof the Dr. Hernán Henríquez Aravena Hospital inTemuco, Chile. This high-complexity laboratory per-forms analyses in the areas of haematology andhaemostasis, clinical biochemistry, microbiology,tuberculosis, serology, flow cytometry and molecularbiology. It carries out approximately 3.5 million testsper year and is furnished with a Labcore LaboratoryInformation System (LIS), which allows it to verify theresults of the analysers and transmit them to the com-puterised record system, maintaining the traceabilityof the clinical samples. The intra-laboratory pre-ana-lytical section of the hospital is subdivided into theareas of reception, admittance, labelling, centrifuga-tion and distribution, and is staffed by one medicaltechnologist (MT) and seven paramedic technicians(PMT).The hospital has 720 beds, of which 60 areassigned to the critical patient care unit (ICU, ITU).

turnaround times for glucose (Medicine) and haematocritin both services. In the analytical and post-analytical phase(not intervened), an increase in turnaround times wasobserved in some cases.Conclusions: Other studies have indicated that the applica-tion of the Lean methodology in clinical laboratoriesimproves workflow, increasing effectiveness and efficiency.This study showed an improvement in the delivery time oftest results (glucose – Emergency), giving rise to a cultureof cooperation and continuous improvement. It would,however, be essential to address the management modelintegrating the analytical and post-analytical phases.

Keywords: clinical laboratory, Lean methodology, pre-analytical phase

post-analiti~koj fazi uo~eno je izvesno pove}anje obrtnih vre-mena u izvesnim slu~ajevima.Zaklju~ak: Druga prou~avanja koja su primenjivala Leanmeto dologiju u klini~kim laboratorijama ukazuju na pobolj -{a nje protoka, efikasnosti i efektivnosti. Ovo izu~avanje uka -zuje na pobolj{anje vremena isporuke rezultata ispitivanja(glukoza – hitnoj slu`bi), ukazuju}i na stalnu mogu}nost po -bolj{anja. Potrebno je ukazati da je neophodna primenamenad`menta na integrisanu analiti~ku i post-analiti~u fazu.

Klju~ne re~i: klini~ka laboratorija, Lean metodologija,pre-analiti~ka faza

28 Letelier et al.: Applying the principles of Lean management to clinical laboratory

Pre-intervention Lean training

Implementation of the Lean Project, staff train-ing in Lean Health Care methodology and a Kaizenevent took place between December 2017 andJanuary 2018.

Intervention and data collection and analysis

For benchmarking process improvement towardour goal, glucose and haematocrit parameters wereselected. Glycaemia was measured using ARCHI-TECT 2000 and ARCHITECT ci8200 systems, where-as haematocrit was measured using an ADVIA 2120ihaematology analyser. The primary outcomes mea-sured were turnaround times (TT) for individual test-ing modalities, defined as the time interval betweenarrival of the sample at the laboratory and final result.

An analysis was conducted of 6648 dataextracted from the LIS system of patients from themedicine (M) and adult emergency (AES) services.The study was approved by the Research EthicsCommittee, Universidad Católica de Temuco.

The samples were collected by the phlebotomyteam using standardised methods and entered intothe intra-laboratory pre-analytical section in the firstquarter of 2017 (pre-intervention) and first quarter of2018 (post-intervention), during working hours.

The database was divided into four groups a)Glucose - Adult Emergency Service (Glucose-AES); b)Glucose - Medicine (Glucose-M); c) Haematocrit -Adult Emergency Service (Haematocrit-AES) and d)Haematocrit - Medicine (Haematocrit-M). To mea-sure the impact of the intervention in line with therouting of the sample through the laboratory, eachgroup was subdivided into four segments: Reception-distribution of samples (R-D),which considers fromthe reception of samples at the window or via pneu-matic delivery system until their distribution within theintra-laboratory pre-analytical section; Distribution-section (D-S),which considers the distribution of sam-ples within the intra-laboratory pre-analytical sectionuntil their reception at the areas of ClinicalBiochemistry and Haematology; Section-result (S-R),which considers from the arrival of the samples to theanalytical areas; and Result-validation (R-V), whichcomprises from the result of the analysis until its vali-dation.

Data Analysis

Data analysis was performed using the GraphPad Prism version 6.0 (San Diego, California USA)statistical software. The Kolmogorov-Smirnov test wasused for the normality analysis, while the Mann-Whitney U test was used for independent samples,and p<0.05 was considered to be statistically signifi-

cant. For this analysis, the time average of year 2017was considered to be 100% vis-à-vis the timesobtained for 2018.

Results

»Intra-laboratory pre-analytical phase« pre-inter-vention workflow

Figure 1A shows the workflow during the pre-intervention period in the clinical laboratory. In thisperiod, the samples and request forms arrive at thelaboratory reception area via a pneumatic deliverysystem or directly at the window. After accepting thesamples into the section, their admittance, labelling,centrifugation and distribution were carried out. Inthe pre-analytical section, a discontinuous flow wasobserved in the route of the samples, regardless ofthe unit of origin (Figure 1A), giving rise to an accu-mulation of clinical samples and a delay in recordingthe data in the LIS system. Moreover, the workflowand staff functions did not allow for adequate coordi-nation to ensure a continuous flow of the samples.The staff functions during the pre-intervention stage,in which these functions were not clearly established,generating a work overload in part of the staff (PMT3)and consequently a delay in the sample flow in certainareas of the laboratory.

Laboratory infrastructure

During the pre-intervention period, the laborato-ry was set up in three physical spaces (Sample recep-tion, distribution and centrifugation), where thereception of the samples and their tracking were sep-arated physically, hindering communication betweenthe staff of both sections. Each of these areas wereseparated by three doors for the entry and exit ofstaff, sample distribution and separation of trackingand centrifugation areas. In addition, the gasanalysing equipment was some distance away fromthe tracking section, complicating sample flow.During the intervention stage the wall separating thereception area from the distribution area was knockeddown leading to an improvement in samples flow androuting, also the arterial gas analysers were relocated,a space and a centrifuge solely for use in priority sam-ples was assigned. One single access and exit routewas established for the laboratory staff and the sam-ple distribution door was blocked.

New workflow post-intervention

After the intervention, a reordering of the labo-ratory staff was carried out, their functions were reas-signed and delimited according to the new workscheme inspired by the Lean methodology, generat-ing rotating work schemes, encouraging teamwork

and collaborative work. Although the laboratory staffwas maintained. Figure 1B presents the reorganisa-tion of the laboratory workflow (post-interventionperiod) and the reassignment of PMT functions togenerate a continuous and unidirectional flow, estab-lishing priorities depending on the service of origin. Inthis regard, priority is established by the PMT of thesample reception area in accordance with a list of pri-orities depending on origin, degree of urgency and

type of test, moreover to provide assistance in pre-analytical sections and maintenance of necessaryconsumables for sample taking (PMT1 and PMT2)under the supervision of the Medical Technologist ofthe unit. Additionally, a distribution of the »digitalisa-tion and labelling« function was carried out depend-ing on the type of sample received (priority, inpatientand culture) for PMT3, PMT4 and PMT5 respectively,optimising the time of entry into the system and anal-

J Med Biochem 2021; 40 (1) 29

Figure 1 A Workflow pre-intervention period and B. workflow post-intervention period, route of clinical samples according tostaff functions. By using the information obtained from our observations and interviews with laboratory personnel (PMT:Paramedic technician; MT: Medical technologist), we redesigned the preanalytic process using Lean management principles.In the process redesign, we were used the same laboratory space and personnel for preanalytic functions, although with a redis-tribution of functions. Moreover the request form would remain together with the sample during the entire entry into the systemand labelling process to generate a continuous and unidirectional flow. The resesigned process map is shown in B.

30 Letelier et al.: Applying the principles of Lean management to clinical laboratory

ysis of the samples. Moreover, the intervention estab-lished that the medical prescription would remaintogether with the sample during the entire entry intothe system and labelling process.

With regard to the centrifugation and distribu-tion process, it is necessary to verify the condition ofthe sample prior to proceeding with these processes,and samples may be discarded if deemed necessary.Samples meeting the standards are tracked by thesystem, making it possible to monitor their routethrough the different sections of the laboratory.

Subsequently they are centrifuged in accordance withtheir priority order, with exclusive-use centrifugesavailable to deal with urgent samples. Finally, samplesare sent to the internal distribution window, where adesk with different colours (representing each sec-tion) was implemented to provide a visual aid andspeed up the distribution process. Additionally, theseparamedical technicians can provide support in win-dow section (reception, admittance / labelling), sam-ple taking, in maintenance of consumables, process-ing of urine samples and replacement of materials ifnecessary.

Kaizen Event

Figure 2 presents turnaround times (from thearrival of the sample at the laboratory until its valida-tion) for pre-interventionand post-intervention glu-cose and haematocrit tests. After theintervention, asignificant reduction in the laboratory TT for Glucose–AES was observed (84 to 73 min, 13%, p < 0.05,pre and post). In contrast, although a reduction inthe times of the Glucose-M (119 to 106 min, 10.7%,p = 0.1530, pre and post), Haematocrit-M (90 to89 min, 1.2%, p = 0.9503 pre and post) andHaematocrit-AES (54 to 53 min, 0.3%, p = 0.1468pre and post), was observed, the results were not sta-tistically significant.

In the analysis by segments, in the intervenedphase (pre-analytical RD + DS phase; Figure 3) a sig-nificant reduction in the Haematocrit M – AES param-eter was observed. On the other hand, when studyingthe analytical (S-R; Glucose M – AES)and post-analyti-cal (R-V; Haematocrit M – AES) phases (data not shown),a reduction of turnaround times was found (p<0.05).However, in S-R; Haematocrit M – AES and in R-V;Glucose M – AES, an increase in TT was observed.

Discussion

The hospital care system has critical points thataffect the expedite and timely attention of users,which are subject to improvement. To address thisissue it has been seen that the application of the Leanmethodology in health institutions and particularly inclinical laboratories can improve the workflow,increasing patient satisfaction, through an efficientdelivery of test analysis results (12–15). Lean placesemphasis on the elimination of unnecessary stepsthat provide no value added, in a context of limitedfinancial resources in terms of space, equipment andhuman capital.

The analysis conducted in the pre-interventionstage made it possible to detect critical points thatwere modifiable and allowed changes to be made inlaboratory staff functions, workflow and infrastruc-ture. In terms of workflow at the laboratory, theadjustments led to the establishment of a continuous

Figure 2 Turnaround times for glucose and haematocrittests, 2017 versus 2018 at the Medicine (M) and AdultEmergency (AES) services: Com parison charts of turn -around times (TT) for the parameters studied, consideringa p value < 0.05. A statistically significant difference wasonly observed in the Glucose – AES parameter. NS denotedno statistical differences.

Figure 3 Comparison of turnaround times in haematocritand glucose tests at the Medicine (M) and Adult Emergency(AES) services, Pre-analytical phase (sections R-D and D-S).Average and standard deviation. NS denoted no statisticaldifferences.

J Med Biochem 2021; 40 (1) 31

and unidirectional flow (Figure 1B), giving priority tothe work in accordance with the service of origin.Thus, during the reception of samples, it was estab-lished that PMT1 and PMT2 are to examine theircondition and check that the request form containspatient data, origin, test required, informed consentwhen necessary and signature of the requesting doc-tor. Noncompliance with these requirements are to berecorded and notified as cause for rejection. Duringthe digitalisation of the samples in the LIS system, anew control point was established in order to checkthat the information contained in the test requirementand the sample are complete. In the event that asample is unsuitable, this observations to be enteredinto the LIS system, noting the criterion for rejectionand requesting a new sample. The results show thatthe intervention inspired on the Lean methodologysignificantly reduced the turnaround times in the glu-cose parameter issuing from the adult emergency ser-vice.

To see whether intervention in the pre-analyticalphase would have an impact on other sections of thelaboratory, the routing segments of the samples wereanalysed in terms of reception-distribution (R-D); dis-tribution-section (D-S), section-result (S-R) and result-validation (R-V), showing that the interventionreduced the turnaround time in the intra-laboratorypre-analytical phase (Figure 3). However, these sameresults were not observed in the analytical and post-analytical phases (data not shown), where in somecases the turnaround time increased.

In a similar manner to the Moron-Castaneda etal. (16) study, a reduction in analysis and result timewas obtained, lowering turnaround times in up to 9minutes and improving client satisfaction.

Although the analyses per segment showed thatthere is a reduction in response times, inS-R;Haematocrit M–AES and R-V; Glucose M–AES anincrease in response times was observed, suggestingthat it is necessary to systematise and address theentire model, including the processes in the analyticaland post-analytical phases. The results observedcould be explained in part by the fact that theimprovement in the pre-analytical phase gave rise toa greater workflow toward the subsequent areas (ana-lytical and post-analytical), an also because there wasan increase in the demand for test requests in 2018.The above supports the idea of establishing improve-ments in the analytical phase in this area of the labo-ratory. The evidence shows that optimising workflowin all its areas via a management model would make

it possible to optimise the process, giving rise to acontinuous flow for both specimens and operator(14).

The re-design in the organisation of the labora-tory structure made it possible to optimise resources,improve workflow dynamics and needs, taking intoconsideration that no single organisation modality hasbeen implemented. In terms of staff satisfaction, thefeedback was positive, showing that the interventioncontributed to better define the functions of eachmember of the team. Limitation to the study is that itwas carried out in just one institution and the resultscould prove not to be applicable in other clinical lab-oratories with very different workflows. Lastly, usersatisfaction was not assessed, which would make itpossible to establish new criteria to be modified inorder to achieve continuous improvement of theseunits.

Conclusion

The results show that the Lean methodology isapplicable to improve the pre-analytical phase in thelaboratory, expediting the turnaround time of thedelivery of clinical test results. This study reinforcesthe usefulness of applying the Lean model to improvethe efficiency of diagnostic processes, and was one ofthe first experiences in Chile in the use of thismethodology in a clinical laboratory setting.

The intervention carried out in this study wasachieved with minimum financial investment (exceptfor the structural modifications), by means of optimis-ing teamwork and assertive communication, with nostaff changes made, and contributing to install a cul-ture of continuous improvement in the laboratory.

Acknowledgements: The authors wish to expresstheir appreciation to the work team at the clinicallaboratory of the Dr. Hernán Henríquez AravenaHospital of Temuco and to the Roche Diagnostics®Company for the staff training process. Researchfunding: Supported by FEQUIP2018-PL-06 and VIPUCTN°2016PF-PL-04 grant from the Vicerrectoría deInvestigación y Postgrado, Universidad Católica deTemuco.

Conflict of interest statement

All the authors declare that they have no conflictof interest in this work.

32 Letelier et al.: Applying the principles of Lean management to clinical laboratory

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Received: April 11, 2020 Accepted: May 10, 2020