J Med Biochem 2010; 29 (4) DOI: 10.

2478/v10011-010-0036-5

UDK 577.1 : 61 ISSN 1452-8258

J Med Biochem 29: 330 –338, 2010 Review article

Pregledni ~lanak

CONCEPTS FOR LEAN LABORATORY ORGANIZATION

KONCEPT ORGANIZACIJE LEAN LABORATORIJE

Gabriele Halwachs-Baumann

Department for Laboratory Medicine, Central Hospital Steyr, Steyr, Austria

Summary: In the last decades, hospital laboratories are Kratak sadr`aj: U poslednjih nekoliko decenija, bolni~ke
beset on all sides by demands to lower the costs of laboratorije suo~ene su sa zahtevima za smanjenje tro{kova
laboratory procedures and at the same time to provide (i) laboratorijskih postupaka i istovremeno i) pru`anje br`ih i
more rapid and usable services, (ii) a broader spectrum of dostupnijih usluga i ii) obra|ivanje {ireg spektra parame-
parameters, and (iii) process a higher frequency of spe- tara i iii) ve}e frekvencije uzoraka. Ovi zahtevi poti~u od pa-
cimens. These demands are voiced by patients, physicians, cijenata, lekara, bolni~kih uprava i vladinih agencija. Tako
hospital administrators, and governmental agencies. Thus, se od uprave laboratorije o~ekuje da snizi tro{kove, pobolj-
laboratory management is required to decrease costs,
{a efikasnost i omogu}i zadovoljstvo klijenata, pri ~emu
increase efficiency, and promote customer satisfaction
under the consideration of quality to be of primary impor- kvalitet ima presudnu ulogu. Pored glavnih poslova labo-
tance. Beside the main task of a laboratory (i.e. the ana- ratorije (npr. analiziranje uzoraka pacijenata, tuma~enje
lysing of patient specimens, interpretation of results, expert rezultata, stru~no savetovanje klini~ara), va`ni zadaci i
advice for clinicians), quality management, education of odgovornosti ti~u se upravljanja kvalitetom, edukacije teh-
technicians and medical staff, research and development, ni~ara i medicinskog osoblja, istra`ivanja i razvoja, kao i
and development of economic strategies are important razvijanja ekonomskih strategija. Organizacija »Lean« labo-
duties and responsibilities. A lean laboratory organisation is ratorije va`an je uslov za uspe{no obavljanje tih zadataka.
an important condition to cope these duties. Lean labo- Koncept »Lean« laboratorije mora obuhvatiti preanaliti~ki,
ratory concepts have to include the preanalytical, analytical analiti~ku i postanaliti~ku fazu. Strate{ke odluke o planira-
and postanalytical period. Strategic planning decisions nju moraju biti dugoro~ne i pre svega zasnovane na infor-
have to be based primarily on information derived from the macijama iz spolja{nje sredine. Koncept »Lean« labora-
external environment and have to be long-term. Lean
torije uvek podrazumeva holisti~ki pristup, koji uklju~uje
laboratory concepts always have a holistic view, including
medical demands and economic aspects. An example will medicinske zahteve i ekonomske aspekte. Bi}e dat primer
be shown of how lean laboratory concepts influence the na koji na~in koncept »Lean« laboratorije uti~e na orga-
organisation, efficacy and performance of a hospital labo- nizaciju, efikasnost i delatnost bolni~ke laboratorije.
ratory.
Klju~ne re~i: automatizacija, »Lean« laboratorija
Keywords: automatization, Lean laboratory

Introduction
Laboratory testing is an integral part of the
Address for correspondence: decision-making process, and results of laboratory
Univ. Prof. Prim. Dr. Gabriele Halwachs-Baumann testing often strongly influence medical diagnoses
Department of Laboratory Medicine and therapy. In about 65% of cases the clinical
Central Hospital Steyr
Sierningerstrasse 170
4400 Steyr, Austria
Phone: +43 (0)5055466 25300 Abbreviations: GDP: gross domestic product, STAT: short
Fax: +43 (0)5055466 25304 turn-around time; POCT: point of care testing, FTE: full
e-mail: gabriele.halwachs-baumannªgespag.at time equivalent
J Med Biochem 2010; 29 (4) 331

laboratory is essential for the determination of diag- same time reduce costs, but comply with the
nosis (1, 2). In contrast to this, the costs for laboratory increasing demand for quality and reduced turn-
diagnosis are nowadays only 1.5–2.5 % of the total around time. And all that has to be performed by less
health expenditures (3, 4). That means a reduction of staff. Lean Laboratory Organization is an important
cost of about 2 percent points in the last ten years condition to cope with this »lab paradox«.
(i.e. in the mid nineties the laboratory costs were
about 3.5–5 % of the health expenditures) (5–7).
Since health expenditures all over the world What does »Lean Laboratory
increase continuously (Table I), politicians and thus Organization« mean?
the management of hospitals demand reduction of »Lean Laboratory Organization« is based on
cost. Irrespective of the low share of expenses the »Lean Thinking«, a management system whose
hospital lab is often blamed for costs too much, and origins lie in post-World War II Japan. At that time
outsourcing to an outside lab seems to be the so- Toyota developed the Toyota Production system, with
lution to that problem. Although that might bring a its pillars of »Just in Time« and »Built-in-Quality« (11).
short-dated benefit, for longer periods the expendi- The goal of Lean Thinking is »the endless trans-
tures can be expected to rise, due to increasing formation of waste into value from the customer’s
consequential charges at clinical departments (longer perspective«, where waste is »anything that does not
hospitalization of patients, increasing application of add value to the final product or service, in the eyes
blood products, etc.) and increasing STAT and POCT of the customer«, and value is »the capability to
services. To avoid this undesirable development, the deliver the product to the customer, at the right time
challenge for the lab and hospital is to evaluate cri- and at an appropriate price« (11). These principles
tically the situation and to remedy systemic problems can be transferred to health systems, amongst others
inside the hospital, so that they would be able to the clinical laboratory (11–13). To avoid waste will not
compete with outside labs. only improve quality, it will also save money. It has
Along the pressure to contain cost and operate been estimated that waste accounts for 30 % to 50 %
efficiently, regulatory requirements, health-care of health care spending (14, 15).
trends and technological/equipment advances signi- Lean laboratory concepts always have a holistic
ficantly influence changes in clinical laboratories (8, view, including medical demands and economic
9). Beside the main tasks of a laboratory (i.e. the aspects. Strategic planning decisions have to be based
analysing of patient specimens, interpretation of primarily on information derived from the external
results, expert advice for clinicians), quality mana- environment and have to be long-term. The demands
gement, education of technicians and medical staff, of the customer have to be fulfilled completely and
and research and development are important duties economically. So, the view on the laboratory has to be
and responsibilities. In a 2004 study (8) the top five changed: the internal view has to be replaced by an
reasons impacting change in the clinical laboratory external view. The first thing that must be done is
were the need to (10): defining the customers and their needs. A depart-
1. reengineer workflow ment for solid organ transplantation has other
2. decrease turnaround times requirements than a department for orthopaedics.
Intensive care units have different needs compared to
3. reduce errors in testing or reporting
rehabilitation clinics. These needs influence the work
4. have availability of qualified staff in the lab by defining parameter spectrum, expected
5. increase outreach. turnaround time, and sample size. On the other hand
the lab influences the work in the clinical departments
So the lab manager has the problem of squaring
by influencing the time since diagnosis and therapy,
the circle: to process a higher frequency of specimens
guidance of therapy and length of hospital stay
and a broader spectrum of parameters and at the
(16–18). Second, you have to measure the initial
situation. Many hospital labs are certified or
Table I Total expenditure on health (% GDP) in some accredited to the EN ISO standards (e.g. EN ISO
OECD member states (www.oecd.org) 15189:2003 Medical laboratories – particular
requirements for quality and competence). These
1998 (% GDP) 2008 (% GDP) standards provide a good toolset for measuring
Austria 10.0 10.5 processes and quality. The major process in a lab is
Germany 10.2 10.5
the way of a specimen tube through the lab. To
visualize this process allows the next step – analyzing
Slovenia 7.9 8.3 this process. An essential Lean laboratory organi-
Slovak Republic 5.7 7.8 zation tenet is to keep the specimen tubes moving,
United Kingdom 6.7 8.7 avoiding periods when a specimen sits around waiting
for the next step in the process. Creating a scoring
United States 13.4 16.0 system for parameters reflecting the urgency of their
332 Halwachs-Baumann: Lean laboratory

processing allows reengineering and improving this of the laboratory and will certainly not be the same for
process. And last, but not least, control the process. all laboratories (22). Even for various departments of
This course of action is called the DMAIC-roadmap a laboratory the automation requirements can differ.
(Define-Measure-Analyze-Improve-Control) (19).
Nevertheless, laboratory automation involves
Beside the explanation of what lean laboratory much more than a robotic system within a laboratory.
organization means, it is also important to define what Automation design philosophy has evolved from a
lean laboratory organization does not mean. Lean hardware-based approach to a software-based
laboratory organization is not about head count red- approach (7). The laboratory information system
uction. It is about being able to do more, improving (LIS) has a crucial part for the function of automation.
patient care with existing resources (20). Lean It is involved in both analytical and »peri-analytical«
laboratory organization is not about making people processes. The latter includes both preanalytical pro-
work harder and faster. On the contrary – lean labo- cesses, such as processing of physicians’ orders and
ratory organization should enable the employees to specimen accessioning, and postanalytical processes,
work at a smooth, comfortable pace, without inter- such as result verification and report generation (23).
rupting pressure and stress (21). Very often attention is turned to the preanalytical
processes, which are supported by the automation
either as part of total laboratory automation or as
Laboratory automation stand alone solution, and the postanalytic processes
Lean Laboratory Organization and automation are unattended. But automation very often results in
fit together quite well provided that two requirements consolidation of multiple disciplines (e.g. clinical
are fulfilled: chemistry and immunology), and thus the amount of
results produced by an automation system increases
1. Automation is a tool not a solution. enormously. Automated data reporting (also known
2. Do not automate waste. as autoverification) can help to deal with this pack of
data. By this process a computer verifies patient
So, automation must always be based on an results by applying mathematical algorithms and delta
improvement of the process. Thus, the goal of a checks, reviews coded comments, and performs data
successful automation project must be to change the mining. This frees up technical staff to focus their
way in which the laboratory’s work is done. This attention on tests that require further investigation or
involves changing not only tools and processes, but manual confirmation (10). Benefits of autoverification
also jobs, structure, and ultimately, the way people are reduced fatigue associated with reviewing data,
think about their work (22). Reasonable automation reduced errors from overlooked abnormal results,
provides improved efficiency coupled with reduction increased patient safety, improved laboratory quality,
in processing errors (7), improved turnaround times, reduced turnaround time (10).
automated repeat and reflex testing, enhanced safety,
and improved specimen tracking (23). This sounds Beside LIS architecture is an important basis for
quite similar to the definitions and topics of lean a well-functioning lab. Modern laboratory design, as
laboratory organization. it began in the late 19th century, is characterized by a
modular arrangement of benches, cabinets, and
There exist various types of automation (10, 24, fume hoods. The primary assumption of this system is
25). that most laboratory activities involve the manipu-
(i) Total laboratory automation: this term is now lation of materials and apparatus at the bench by
commonly used to describe automation that includes fixed casework and small apparatus. Over time, this
a preanalytical system connected to one or more rigid ergometric module has been abandoned for
modular analytical systems on one continuous line open plan settings more conductive to the use of
using a track design. large analyzers. This was done in many cases at the
expense of the rational coordination of laboratory
(ii) Modular laboratory automation: this term utilities. As the rational planning module has lost
refers to a system that incorporates some automation importance, so too have many of the traditional
pieces, although not everything is connected. boundaries between disciplines. The result, if not
(iii) Workcell/workstation automation: this type is carefully controlled, often is a clinical laboratory
similar to modular automation. It may include items whose ad hoc planning mirrors that of many of the
involved in the preanalytical phase and have some older hospitals (26, 27).
analytical departments placed on an automated line.
Nevertheless, some samples still need to be manually
sorted and taken to departments that are not part of Reorganizing the lab department:
the workcell line for testing. a hospital case study
The appropriate choice of automation techno- The central hospital Steyr consists of 2 sites. The
logy depends on the needs and on the infrastructure larger one with 700 beds is located in Steyr (a town
J Med Biochem 2010; 29 (4) 333

with 40.000 inhabitants). It consists of 21 clinical Initial situation (Table II)

departments, including an interdisciplinary intensive
The initial spatial pattern of the department of
care unit (internal medicine, neurology, pulmonary
laboratory medicine consisted of 594 m2 spread over
disease) and an intensive care unit at the department
2 buildings, and in one of these buildings situated on
of anaesthesiology. Beside these, a department of
3 floors. Beside the head of the department, 3
neonatology and children disease, a department of
medical specialists for laboratory medicine and
internal medicine (cardiology, nephrology and dia-
transfusion medicine, 32 medical technologists and 1
lysis, gastroenterology, oncology, etc.), a department
laboratory assistant were assigned to the department.
of general surgery and one for trauma surgery exist,
Per year about 1.730.000 tests were performed, and
as well as others liker ophthalmology, psychiatry and
4.800 blood products were checked and released by
ear-nose and throat, etc. There are a 24-hour,
the blood bank. Only the core lab, but not the STAT
7d/week emergency department and 22 outpatient
lab in Enns and the blood bank, was certified to EN
centres. About 40.000 inpatients and 300.000
ISO 9001: 2008.
outpatients are treated per year. The smaller site is
located in Enns (11.000 inhabitants), and consists of
a department of internal medicine, including a small
intensive care unit, and a department of psycho- Implementation process
somatic medicine. Sort: Unnecessary and antiquated methods
The department of laboratory medicine at the were removed. Administrative work was shifted from
central hospital Steyr consists of a 24-hour, 7d/week medical technicians to a secretary. Redundancies
core lab (clinical chemistry, immunology, haemato- were eliminated (e.g. blood glucose measurement at
logy, haemostaseology, urine diagnosis), including a the ward was done by technicians as well as by
blood bank, and special divisions for molecular diag- nurses. In agreement with clinicians and nurses this
nostics, chromatographic determination of drugs and work is now done only by the nurses).
endocrinological parameters, and autoimmune diag- Simplify: Processes were simplified (Figure 1 and
nostics. In the 20 km dislodged hospital site in Enns 2). Splitting of samples was reduced to a minimum.
a STAT lab is located. Samples and materials were clearly assigned ONE
In 2006 the process of reorganisation of the working place. Spatial arrangement of working areas
department of laboratory medicine began, including with the same demands on employees led to a clear
floor plan of the new lab.
– architectural planning of a new lab
– homogenisation, consolidation and automation of Sweep: Serum and plasma samples are sorted
the technical equipment (for storage or further processing) automatically by
the automation system, reducing the searching. Auto-
– certification of the whole department according to verification was implemented, focusing the attention
EN ISO 9001: 2008. on tests that require further investigation.
Standardize: The technical equipment of the
core lab (Steyr) and the STAT lab (Enns) were

Table II Benchmark data of the Department of Laboratory Medicine 2006–2010.

2006 2010
Assigned area 594 m2 Spread over 5 places 746 m2 Spread over 2 places
Assigned staff Persons FTE Persons FTE
Medical specialists 4 3.5 4 3.5
Medical technologists 32 28.5 34 26.5
1 person night shift, 2 persons standby
2 persons night shift, 1 person standby (Enns)
(Enns and blood bank)
Laboratory assistant 1 1 1 0.75
Secretary 0 0 1 0.5
Workload estimated for 2010
Performed tests 1.730.000 2.250.000
Checked and released
4.800 5.000
blood products
334 Halwachs-Baumann: Lean laboratory

harmonized. That led to a harmonization of methods, For urine analysis an instrument for automatic
reagents, reference values and processes. generation of urine sediment was connected to the
instrument for automated performance of test stripes
Standard operating procedures (SOP) were
for urine analysis, leading to a standardized and faster
written, adjusting the SOPs from the STAT lab to processing of urine analysis
those of the core lab, whenever it was reasonable.

Before automation

Figure 1a The way of a serum sample through the laboratory before the implementation of automation for clinical chemistry
and immunology.
J Med Biochem 2010; 29 (4) 335

After automation

Figure 1b The way of a serum sample through the laboratory after the implementation of automation for clinical chemistry
and immunology.
336 Halwachs-Baumann: Lean laboratory

Dimension Vista® Immulite 2000 XPi with VersaCell® StreamLAB analytical

workcell for sample
management with
centrifuge and tube sealing

Figure 2 Automation and consolidation of clinical chemistry and immunology, including pre- and postanalytical processes
(technical equipment: Siemens Healthcare Diagnostics).

3000 A 900 B
800
2500 Natrium 2009: n=5.114 Troponin I 2009: n=1.323
Natrium 2010: n=5.071 700 Troponin I 2010: n=1.463
Number of results

Number of results

2000 600

500
1500
400

1000 300

200
500
100
0 0
30 60 90 120 150 180 30 60 90 120 150 180
Minutes Minutes
2009 2010 2009 2010

Figure 3 Turnaround time for the parameters natrium (A) and Troponin I (B) before and after automation.
J Med Biochem 2010; 29 (4) 337

An automated slidemaker and stainer was sepsis monitoring were implemented. Since January
implemented in the haematology division. 2010 the Department of Laboratory is situated in the
new accommodation. Automation and consolidation
Automation and consolidation of clinical che-
mistry and immunology, including pre- and postana- of clinical chemistry and immunology led to a
lytical processes were implemented supporting the reduction of turnaround time (Figure 3).
standardization of serum and plasma samples pro-
cessing (Figure 2). Additionally this led to a reduction
of manual work done by medical technicians. Conclusion

Sustain: Internal and external audits are now Lean laboratory organisation lead to improved
performed in the whole department of laboratory performance, which has proved beneficial as de-
medicine at least once a year. Management ratios mands on the laboratory have grown. Our expe-
were implemented, allowing the assessment of riences confirmed those of other labs (12, 13, 15):
quality, efficacy, financial development and customers efficacy and turnaround time can be reduced. A
needs. decrease in cost despite an increase in demands was
possible, making the hospital laboratory competitive
with outside labs. Change and evolution of the labo-
Present situation (Table II) ratory will go on, since lean laboratory management
is a never-ending process.
Although the workload increased > 30 % in the
last four years, there was a total primary cost
reduction of 9 %. A reduction of 2 FTE was possible
Conflict of interest statement
in parallel to the implementation of a second night
shift. New parameters concerning the field of The authors stated that there are no conflicts of
molecular diagnosis, autoimmune diagnosis and interest regarding the publication of this article.

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Received: July 7, 2010

Accepted: August 19, 2010