2017, Volume 33, Number 1, Page(s) 047-057
Improving Histopathology Laboratory Productivity: Process Consultancy and A3 Problem Solving
Kutsal YÖRÜKOĞLU1, Erdener ÖZER1, Birsen ALPTEKİN1, Cem ÖCAL 2
1Department of Pathology, Dokuz Eylül University, Faculty of Medicine, İZMİR, Turkey
2Roche Diagnostics Turkey A.Ş., Workflow, IT and Consultancy Manager, İstanbul, Turkey
Keywords: Quality control, Histopathology, Internal-external control
The ISO 17020 quality program has been run in our pathology laboratory for four years to establish an action plan for correction and
prevention of identified errors. In this study, we aimed to evaluate the errors that we could not identify through ISO 17020 and/or solve by means
of process consulting. Process consulting is carefully intervening in a group or team to help it to accomplish its goals.
Material and Method: The A3 problem solving process was run under the leadership of a ‘workflow, IT and consultancy manager’. An action
team was established consisting of technical staff. A root cause analysis was applied for target conditions, and the 6-S method was implemented
for solution proposals. Applicable proposals were activated and the results were rated by six-sigma analysis. Non-applicable proposals were
reported to the laboratory administrator.
Results: A mislabelling error was the most complained issue triggering all pre-analytical errors. There were 21 non-value added steps grouped
in 8 main targets on the fish bone graphic (transporting, recording, moving, individual, waiting, over-processing, over-transaction and errors).
Unnecessary redundant requests, missing slides, archiving issues, redundant activities, and mislabelling errors were proposed to be solved by
improving visibility and fixing spaghetti problems. Spatial re-organization, organizational marking, re-defining some operations, and labeling
activities raised the six sigma score from 24% to 68% for all phases. Operational transactions such as implementation of a pathology laboratory
system was suggested for long-term improvement.
Conclusion: Laboratory management is a complex process. Quality control is an effective method to improve productivity. Systematic checking
in a quality program may not always find and/or solve the problems. External observation may reveal crucial indicators about the system failures
providing very simple solutions.
The report of the Institute for Medicine in 1999 called
attention to systematic medical errors as the 8th leading cause
of death in the U.S.A. 1
. Quality systems in healthcare as
well as in pathology have been proposed and defined since
then. Implementation of these quality systems provided
an improvement in healthcare service delivery and costeffectiveness.
These systems are based on reducing errors
waste, redundancies, and streamlining work processes 2
Several practices are suggested for anatomic pathology
laboratories. The College of American Pathologists (CAP)
is the leading institution in laboratory quality assurance
and has a specific anatomic pathology quality control and
quality assurance program. The aim of the CAP Laboratory
Accreditation Program is defined as “to improve patient
safety by advancing the quality of pathology and laboratory
services through education, standard setting, and ensuring
laboratories meet or exceed regulatory requirements” 3.
There are a few accreditation programs for the development
and maintenance of standards and guidelines for pathology
laboratories, such as the United Kingdom Accreditation
Service (UKAS) 4 and the Royal College of Pathologists
of Australasia (RCPA) 5. In 2011, a pathology laboratory
accreditation program was established by the Turkish
Accreditation Agency (TÜRKAK) 6. The Turkish Ministry
of Health has recently defined the minimum national
requirements to be followed by the health institutions to
establish national quality standards. These requirements
also include guidelines for pathology laboratories 7.
Errors in anatomic and/or surgical pathology can occur at
the pre-analytical, analytical and post-analytical stages 8.
Most of the pre-analytical errors can be detected during
the analytical phase (slide review). This detection includes
interpretive and/or clinical sampling errors, but not the
non-interpretive errors. As the pre-analytical production
steps are complex in anatomic pathology, automation
does not analyze and resolve all of these errors. Therefore
professional and technical approach is essential for error
Pathology laboratory management is not different
than process management. The most important step
in process management is simplification, described as
“Lean” 9. Pathology laboratory management may be
well-defined, even it is not simplified and recorded. Also
definitions known by the employees may not be enough
for simplification. Shortage of time and budget, lack of
motivation, and workload may interfere in finding solutions
to the problems that arise during process management. An
ISO 17020-based quality control and quality assurance
program has been developed at Dokuz Eylul University
School of Medicine, Department of Pathology, and
accredited by TÜRKAK in 2012, under the auspices of
our institution. Within these quality assurance settings
we try to improve our program by adding different and
new practices to reduce errors. In this study, we aimed to
evaluate the errors that we could not identify and solve by
means of an external observation of process management
that may be more objective and demonstrate unseen
problems, and used the A3 problem solving method. A3
problem solving is an action plan written on a sheet of A3-
sized paper, and aims to define the problems, analyze them
and apply corrective actions.
At the initial step, the process consultant described the A3
process consulting to the laboratory administrator and head
of the department. A survey was developed to describe the
assignment and define its goals as well as the time and effort
required and the possible difficulties. A plan was developed
based on the preliminary problem analysis (Entry).
A team consisting 5 technical laboratory members from
3 different departments in the laboratory was established.
The roles of the consultant, team and the laboratory
administrator was defined and the task plan was developed
The error rate is a part of our quality system and contains
errors reported by the staff, the clinicians or patients, and
the errors determined during system analysis.
Definition of the Problem and Finding Solutions: The A3
problem solving methodology process was established.
Necessary meetings with the team were organized for
brainstorming and all of the team members were asked to
list the problems they encountered in daily practice (Figure 1).
Current condition: The problems were categorized
according to the subjects and sorted in order of importance.
The dimensions of the problems (technological
organizational, informational, psychological, or other)
Target condition: The most relevant problems were listed
and categorized on the priority matrix (Figure 2). The most
important problems with easy solutions to apply were
Root cause analysis: Information about the causes of the
problems, ideas to solve the problems, and an action plan
was organized. The team was requested to ask “5 why”
questions for each of the relevant problems (Diagnosis).
For example; 1) Why is the cassette mislabeled? Because
more than one people are giving orders for labeling at the
same time. 2) Why is the cassette mislabeled? Because it is
impossible to hear the order in a noisy environment.
Responsibility: The results of the root cause analysis were
analyzed and conclusions were drawn on action proposals.
Actions to be taken to deliver the results and the responsible
technical staff were identified and informed (Intervention).
Proposed countermeasures: All of the processes were
written on a map and spaghetti fields were defined (Figure 3). Alternative solutions, the evaluation of alternatives, the elaboration of a plan for implementing changes, and the
proposals were presented to the client. Non-value added
steps were identified and cancelled (Withdrawal).
Plan and follow up: A 6-S vision was created for the
organization (Sort, Straighten, Scrub, Standardize
Sustain, and Safety). Solution proposals for the problems
encountered in root cause analysis were listed. Applicable
proposals were activated immediately. Non-applicable
proposals were listed and submitted to the client in a
written format. Pre-process and post-process 6-S scores
After 1 year, the error rate and distribution were
documented and compared with the previous year’s results.
The main goal of the consultancy process was defined
as a decrease in the rate of reported errors by analyzing
grossing, histotechnique, immunohistochemistry
and histochemistry phases and increase working staff
satisfaction and efficiency. The current state showed
mislabeling (either on cassette or glass slide) or syntax
errors to be the main problem. For the last year; 110 errors
were detected/reported, and 4 of these were from staining
5 from tissue processing, 13 from archiving, 18 from
sectioning, and 30 (28%) from mislabelling issues. 40 of the
errors were from other causes (Figure 4
Mislabeling errors were expressed by the staff to trigger
other errors such as staining failures and archiving errors.
The most important statement by the staff was the loss of
work motivation due to cascading errors triggered by those
mislabeling errors. The significant portion of time spent in
the laboratory did not have an impact on the process. The
target was to reduce the mislabeling error rate by 50%, and
all other errors by 30%.
Spaghetti diagrams were drawn and 21 non-value added
steps (Figure 5) were found. These were grouped in 8
main targets on the fish bone graphic, and included
transportation, people, motion, inventory, waiting, over
processing, over-production and defects (Figure 6). Most
important problems were unnecessary redundant requests
missing slides, archiving issues, redundant activities, and
mislabeling errors (Figure 7). Most of the solutions were
improving visibility and fixing spaghetti problems that
were quick wins and would significantly improve the
process (Table I)
Click Here to Zoom
|Figure 6: Fish-bone graphic consolidating the process foci to quality, laboring, cost/process time.
Click Here to Zoom
|Figure 7: Priority matrix showing most important problems that could be solved easily.
1. The sectioning and grossing area were reorganized.
Unserviceable devices and equipment were thrown away.
The signs were placed to indicate how the working areas
2. Local spaghetti effect was resolved for each area by means
of very simple re-organizations.
3. Inactive devices/equipment were labeled with a newly
designed label for easy recognition and to facilitate repairs
Click Here to Zoom
|Figure 8: Red label formed to take attention to inactive devices/equipment.
Twenty-five questions were asked to team members to
score six-sigma (Table II). Six-sigma evaluation scores
were 100% for histochemistry, 56% for the grossing room
and 24% for sectioning/staining. After application of the
corrective actions, the six sigma score was raised from 56%
to 72% for the grossing room and from 24% to 68% for
After these operational modifications, proposals for longterm
enhancement were presented. The major project was
histology laboratory re-designing to eliminate the spaghetti
effect (Figure 9).
Click Here to Zoom
|Figure 9: Histotechnique room re-designing proposal for lean management.
Another proposal was implementation of pathology
laboratory system to automate all of the phases by barcode
readers. This system included recording at accession, and
usage of the same barcode at the following steps.
After 1 year, there were 64 errors detected/reported. 4 of
these were from staining, 2 from tissue processing, 7 from
archive, 7 from sectioning, while 15 of the reported errors
were mislabeling issues. 26 of the errors were from other
causes. The mislabeling error rate declined to 15 (24.6%)
from 30 (28%).
A spaghetti diagram was not re-drawn without making
any changes in the general organization as it was a
Anatomic pathology is a complex process. The quality
in histopathologic examination has many dimensions
and depends on change for the better. There are several
available management tools to increase productivity and
reduce errors 10
. All of these systems aim to improve
histopathology services for the patients.
All humans make mistakes. The mistakes in a pathology
laboratory are called errors. The meaning of ‘error’ is a
conflicting issue. Mistake and error are synonymous in
terms of quality control. Most people do not use the term
mistake but errors to include all errors includıng human
and machine errors. Mistake is a choice but errors are more
formal determinations of wrong outcomes. Some consider
only the mistakes in the final report as errors 11. Others
consider every mistake as an error made throughout the
process from obtaining the specimen from the patient to
receipt and handling of the information in the report 12.
However, it is obvious that the mistakes at any processes
other than diagnosis may interfere with the diagnosis and
cause a diagnostic error 8. Efficacy of documenting and
correcting errors has been documented 13.
In our quality control and quality assurance program
isolated events are reported as errors and kept in a
permanent log. The internal inspection of a quality program
is getting increasingly complex and detailed because of
the evolution of technology and the need to cover the
governmental regulatory requirements. Some aspects of
the program may be overlooked in internal inspection. An
external audit related to the laboratory quality program
may provide different contributions. We aimed to consult
someone standing out of the system regarding our basic
Quality management programs with databases are powerful
tools to monitor performance improvement. We have been
using a quality management program in our laboratory
for the last four years. We noticed that the program we
used and the staff had become complacent. The program
was not sufficient to solve the same basic problems that
could be solved earlier. We decided to utilize an external
audit mechanism and consider its proposals. This external
consultation was done with the A3 solution method.
A consulting process has 5 phases: 1) the Entry phase
includes client contact, preliminary problem diagnosis
and consult contract, 2) the Diagnosis phase aims at
problem analysis, fact analysis and feedback to the client
3) the Action Planning phase analysis develops solutions
with alternatives and planning, 4) the Implementation
phase adjusts proposals and education, and 5) the
Termination phase is the evaluation and reporting stage
of the process 14. The A3 problem solving process is a
powerful lean management tool. Its main principles are
defining the problem, analyzing it, and applying corrective
action or an action plan written down on a single sheet of
A3 size paper 15. It is not a new technique; it is based
on the Toyota Production System (TPS). An A3 paper is
composed of boxes arrayed in a template. The boxes are
filled in order by the author; 1) finding out the conditions
of the company, and the importance of specific problems
2) describing the contemporary conditions causing the
problem(s), 3) identifying the outcome, 4) analyzing the
situation to establish causality, 5) propose prevention and
adjusting, 6) concerting an action plan, and 7) defining the
follow-up process 16, 17. The A3 problem solving process
is not simple but it has become popular recently with
manufacturers because it does not require expensive training
or software. Some conditions are essential when processing
TPS, A3, or lean management. A systematic real-time root
cause analysis is the core of these systems. The philosophy
of the systems should be well understood. A leadership
support with frontline staff engagement is essential for
successful implementation. “Any improvements must be
made in accordance with the scientific method, under the
guidance of a teacher, at the lowest possible level in the
organization.” 18. The consultant does not try to help the
team as an expert; instead, the consultant helps the team to
We have organized a working group from frontline staff
under the leadership of a ‘Workflow, IT and Process
Manager’. This working group has identified the main
problems. All identified problems were placed in the first
quadrant of A3 paper. They tried to simplify the description
of the problems. Then, all group members were requested
to ask 5 “whys” for each question to investigate the problem
and find the root cause. The answers were again written in
the second box of the A3 paper. All problems and causes
were grouped according to the analytical or spatial features
and placed on the fishbone graphic. The target conditions
were analyzed and written on the third box of the A3 paper.
Then, the 6S exercise was performed. The 5S exercise
is a management technique leading to zero defects and
accidents, safety improvements, and cost reduction 9. It
refers to the steps named after Japanese as 1) Sort (Japanese
term: seiri), 2) Set in order (seiton), 3) Scrub (seiso), 4)
Standardize (seiketsu), and 5) Sustain (shitsuke). Some add
safety as the sixth S. The action plan designed by the 6S
exercise was written on the fourth box of the A3 paper.
No errors would be collected in laboratories that do not
have a mechanism to collect events. When an error is
identified, this event should be directly and immediately
reported to the quality commission. In our laboratory
a quality program has been used for four years and all
errors are identified and reported regularly. According to
these data and A3 analysis, the main problem was found
as mislabeling errors occurring almost in every pre- and
analytical step. This error was expressed to occur from
workload and unnecessary/redundant extra-works. Very
simple solutions were realized. These solutions were
mainly organization fixing to resolve the spaghetti effect
redundant activities and requests, improving visibility. For
a more effective long-term and future solution, operational
transactions such as pathology laboratory system
implementation was suggested 19. However, these simple
steps raised the six-sigma score by 50%.
Total quality in anatomic pathology includes 1) clinical test
selection, 2) specimen collection and handling, 3) grossing
and sampling, 4) laboratory processing and analysis, 5)
reporting, and 6) interpretation/evaluation of the report.
In the provision of these six steps, patient, clinician
specimen collector, laboratory staff and pathologist share
the responsibilities 20. Quality indicators in anatomic
pathology are well defined 21 and include some
parameters such as turnaround time, cytopathologic
histopathologic correlation, false positive or negative rates
and diagnostic discrepancy 22. However, focusing only
on diagnosis-related rates may cause omission of some
important events related to quality and directly influence
the diagnosis. In this respect, real-time root cause analysis
has recently been popular for laboratories 15.
There are 10 common pitfalls in A3 reports 23: 1) The
A3 report background is not clear to an external audience
2) problem definition may not be clear, 3) statement may
cross the line, 4) the target condition may be disguising, 5)
problem analysis is not always relevant, 6) countermeasures
may not address root causes, 7) solution and followup
methodology may be difficult and unprecise, 8) the
problem solver and operator may not function properly
9) A3 review cycle is not a part of normal work, and 10)
improvements comes true by developing people. The team
should be aware of these pitfalls. Most of these pitfalls may
be eliminated by education and integration of the staff to
In this study, process consultancy enabled significant errors
to become visible and provided simple solutions to solve
the problems. We achieved partial recovery and increase
in the client satisfaction. The main goals were reached as
mislabeling errors were reduced by 50%, and overall errors
by 42%. These numbers may be accepted as satisfactory.
However, we concluded that a barcoding system should be
in use in order to prevent all of the mislabeling errors.
As Voltaire said: “We are all full of weakness and errors;
let us mutually pardon each other our follies – it is the first
law of nature.” One of the foci of a quality program should
be human mistakes but there should be no desire to put the
blame on laboratory staff. Frontline staff should be engaged
to engage in problem finding and problem solving. Such
an approach was shown to be successful in the 1800’s by
the Ford and Toyota automotive companies 24, 25. The
main rule of quality is stated as: “It didn’t happen if it is not
written”. So, all errors and events should be monitored and
recorded regularly to be analyzed systematically, anytime.
“Insanity is doing the same thing, over and over again
but expecting different results” (Albert Einstein). As in
our case, this thing may be very simple, causing different
errors in different phases or places. Systematic and regular
checking may not always let the problem be clarified. In
those circumstances, external observation of the system
may reveal crucial indicators about the system’s failures.
The authors thank the members including Yahya Orhan
Tufan, Necati Deniz, Serpil Yılmaz Göçmen, and all
pathology department staff for their contributions and also
Prof. Tarık Tihan for editing the text.
CONFLICT of INTEREST
None of the authors report any financial interest or conflict
of interest regarding the article.
This study was sponsored by Roche Diagnostics Turkey
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