15.

Process
improvement
 15-1: Continual improvement concept
Role in quality Process improvement, one of the
management 12 quality system essentials, establishes Organization Personnel Equipment
system a programme for helping to ensure
continual improvement in laboratory
quality over time. This continual
improvement of the laboratory Purchasing
Process Information
and
processes is essential in a quality inventory
control management

management system.

Documents
Occurrence
and Assessment
management
records

Facilities
Process Customer
and
improvement service
safety

Historical W. Edwards Deming is one of the originators of the concept of continual

basis improvement, the primary goal of a quality management system. Beginning in the
1940s, he worked with manufacturing and industrial processes, and introduced
many of the tools used in quality improvement efforts; his ideas and concepts
are used today to produce reliable, quality laboratory results. Deming outlined
14 points for quality, many of which can easily be applied to the laboratory. For the
purposes of this discussion, two of his points are particularly important:
1. Create constancy of purpose for improvement. The message here is
that there is a need to be constantly working toward making the process
better.
2. Improve constantly and forever. This statement points out that continual
improvement will always be a goal. Perfection is never achieved, but we try to
get as close to it as possible. Process improvement is something that is never
finished, but rather continues on “forever”.

Deming’s The Deming Plan-Do-Check-Act (PDCA) cycle shows how to achieve continual
PDCA improvement in any process.
cycle  Plan—identify the problems and the potential sources of system weakness or
error. Decide on the steps to be used to gather information. Ask the question,
“How can you best assess the current situation and analyze root causes of problem
areas?” Using the information that is gathered through these techniques, develop
a plan for improvement.
 Do—implement whatever plans have been developed—put the plan into action.

168 Laboratory Quality Management System

 15-1: Continual improvement concept

Plan

Act Do

Check

 Check—this refers to the monitoring process. It will be important to assess

the effectiveness of the action taken, using focused review and audit processes.
If the system weakness is complex, a pilot study may be needed in order to
understand all the complexities. After “checking”, revise the plan as required to
achieve the improvements needed.
 Act—Take any corrective action that is required, and then recheck to be sure
that the solution has worked.This cycle is a continuous process, so the laboratory
will begin again with a planning process to continue the improvements.

This is the continual improvement process and, in the laboratory, this process is
applied to all procedures and processes that are a part of the path of workflow.

ISO process ISO 15189 [4.12] describes a very similar set of activities for achieving continual
for continual improvement in the laboratory. These are outlined as follows:
improvement  identify potential sources of any system weakness or error;
 develop plans to implement improvement;
 implement the plan;
 review the effectiveness of the action through the process of focused review
and audit;
 adjust the action plan and modify the system in accordance with the review and
audit results.

Laboratory Quality Management System 169

 15-2: Tools for process improvement
What is process A process is a series of actions or operations contributing to an end. In every
improvement? case, inputs (patient samples) are turned into outputs (patient examination
results) because some kind of work, activity or function is carried out. Process
improvement is a systematic and periodic approach to improving laboratory
quality and the inputs and outputs that glue these processes together. It is a way
of solving problems. If there is a problem, however hard to describe, one or more
processes needs to be improved.

Conventional Many useful techniques have been developed to use in process improvement, and
tools for some have been discussed in other chapters of this handbook. For example, both
improvement internal and external audits will identify system weaknesses and problem
areas. Participation in an external quality assessment is another useful tool; it
allows for comparing laboratory performance to that of other laboratories.

Management review of all information gathered through these activities should

be conducted. In addition, there should be management reviews of the laboratory
records on a regular basis; for example, quality control, inventory management
and equipment maintenance. These reviews will provide useful information about
areas for improvement.

Quality plan
Monitoring Monitoring Monitoring
Quality
Internal audit External audit Quality control
assessment

Opportunities
for improvement

Quality goal

Using information from these reviews and from audits, and through the process
of monitoring the organization’s customer complaints, worker complaints, errors,
near errors or near misses, opportunities for improvement (OFIs) will be
identified. These OFIs will be the focus for corrective action.

170 Laboratory Quality Management System

 15-2: Tools for process improvement

When conducting audits or evaluating laboratory records, it is important to have

a goal or standard of performance. Therefore, quality indicators will be needed
and will have an important role to play.

The plan leads to the goals; OFIs, which are the result of monitoring, lead to the
creation of a new plan, with the process leading to continual improvement.

Newer tools New ideas for tools to use for continual improvement continue to come from the
manufacturing industry. Two of these new tools are now being used in laboratory
quality improvement.
1. Lean is the process of optimizing space, time and activity in order to
improve the physical paths of workflow. This tool of industry is applicable to
laboratories, and many laboratories are currently engaged in creating a lean
system. Lean analysis may lead to revised processes and changes in laboratory
floor plans. This should save time and financial resources, as well as help to
reduce errors in the path of workflow.
2. Six Sigma is also a concept that has come to us from the manufacturing
industry. This consists of a formal structure for project planning
in order to implement change and improvement. In Six Sigma, the
focus is to move toward reducing error to very low levels. The processes that
are described in Six Sigma are define, measure, analyze, improve and control.
These are similar ideas to those already discussed. The Six Sigma concept
applies a very structured method for achieving these processes. (This chapter
will not explore Six Sigma in depth; it is included here so that participants will
become familiar with the term. See Chapter 15 reference list for sources of
Six Sigma information.)

Laboratory Quality Management System 171

 15-3: Quality indicators
Reminder: It is often useful to consider a number of definitions in order to make very clear
What is quality? what is meant by a term such as quality. Philip Crosby, in his essays on quality
management from the 1960s, defined quality as “conformance to requirements,
not as ‘goodness’ or ‘elegance’”.

What is a quality Established measures used to determine how well an organization meets needs
indicator? and operational and performance expectations is a good working explanation of
a quality indicator.

Quality indicators are addressed in ISO 9001 and ISO 15189 documents.

ISO 9001 [5.4.1] requires that quality objectives should be measurable. Thus, the
objectives or indicators must be quantifiable or otherwise capable of analysis,
allowing for an assessment of the success of the quality system.
ISO 9001 [8.4] more specifically requires collecting and analyzing specific
information or data upon which one can determine effectiveness and continual
improvement. Some of the indicators that are required to be considered include
customer satisfaction, conforming to customer requirements for products,
counting the number of preventive actions addressed, and ensuring that suppliers
are providing materials that will not adversely affect quality.

ISO 15189 [4.12.4] states that the laboratory shall implement quality indicators to
systematically monitor and evaluate the laboratory’s contribution to patient care.
When the programme identifies opportunities for improvement, the laboratory
management shall address them, regardless of where they occur. Also, it is stated
that laboratory management shall ensure that the medical laboratory participates
in quality improvement activities that deal with relevant areas and outcomes of
patient care.

Purpose of quality Quality indicators are information that is measured. The indicators:
indicators  give information about the performance of a process
 determine quality of services
 highlight potential quality concerns
 identify areas that need further study and investigation
 track changes over time.

172 Laboratory Quality Management System

 15-4: Selecting quality indicators
General In selecting quality indicators for measuring performance, Mark Graham Brown,
guidelines a leading expert on performance measurement, suggests the following useful
guidelines.1
 Fewer are better; that is, do not try to have too many quality indicators, as
tracking becomes difficult. Few laboratories can effectively address more than
five or six indicators at a single time.
 Link the indicators to the factors needed for success. Choose the quality indicators
that relate to areas that need correction in order to achieve good performance;
select those that will be most meaningful to the laboratory.
 Measures (indicators) should be based around customer and stakeholder needs.
 Measures should look at all levels of the laboratory; if possible, include indicators
that will evaluate function at the top management level, but also flow down to
all levels of employees.
 Measures should change as the environment and strategy changes. Do not stick
with the same indicators over long periods of time.
 Base the targets and goals for the measures on rational values, rather than
values of convenience. They should be established on the basis of research
rather than arbitrary estimates.

Developing Quality indicators—also called metrics—are the specific targets that are regularly
successful examined using objective methods, in order to determine if the goals of compliance
indicators are being met. When developing quality indicators an organization should ensure
the following.
 Objective—the indicators must be measurable, and not dependent on
subjective judgements. It must be possible to have concrete evidence that the
event (or indicator) either occurs or does not, or that the target is clearly met.
 Methodology available—be sure that the organization has the tools needed
to accomplish the necessary measurements. The laboratory must have the
ability to gather the information. If the data or information collection requires
special equipment, then make sure the special equipment is available before
starting.
 Limits—the laboratory will need to know the acceptable value, including the
upper and lower range, before starting measurements. Determine in advance
the limits of acceptability, and at what point a result causes concern. Also
consider what action will be required. For example, how many delayed reports
per month would be considered acceptable? How many would be considered
as requiring corrective actions? How many would require immediate revision
of the action plan?

1 Brown MG. Baldridge award winning quality: How to interpret the Baldridge criteria for performance excellence. Milwaukee, ASQ Quality
Press, 2006.

Laboratory Quality Management System 173

 15-4: Selecting quality indicators

 Interpretation—decisions must be made as to how indicator information

will be interpreted before beginning measurements. Know in advance how
to interpret the information that has been collected. For example, if you are
monitoring completed requisitions to see if they are correct, you need to know
how many samples you have examined, if they have come from multiple sources
or all sources, and whether they are for only one type of sample or all sample
types.
 Limitation—the organization should understand exactly what information is
being provided by the indicator, and be clear on what is not being determined
by the measurement of a particular indicator. For example, if collecting the
number of accidents or errors, do you know if all are being reported?
 Presentation—the organization must decide how to present the information
in order to fully display its value. Some information is best presented in a table,
whereas other information might be best shown by a longitudinal graphic bar or
in text. Presentation of information is important when looking for trends that
predict future outcome.
 Action plan—before beginning the use of an indicator, the laboratory should
have some idea of what to do if the indicator shows that there is a problem.
Also decide how to collect the information, who will collect it, and how long it
will be collected.
 Exit plan—because making these measurements takes time and resources,
there should be a plan as to when to stop using a particular indicator and
replace it with another. Generally, this is done when the original indicator shows
that the operation is working and stable.

When developing quality indicators, be sure to engage the bench-level staff—

those who do the work have a clear understanding of the tasks and outcomes.
The planning process is best done in groups rather than by the quality manager
alone. By engaging the people who actually do the work, the opportunity for
success improves.

Characteristics Good quality indicators (also called metrics) have the following characteristics:
of good quality  measurable—the evidence can be gathered and counted;
indicators  achievable—the laboratory has the capability of gathering the evidence it needs;
 interpretable—once it is gathered, the laboratory can make a conclusion about
the information that is useful to the laboratory;
 actionable—if the indicator information reports a high or unacceptable level of
error, it is possible to do something about the problem identified;
 balanced—consider indicators that examine multiple aspects of the total testing
cycle in the pre-examination, examination, and post-examination phases;
 engaging—indicators should examine the work of all staff, not just one group;
 timed—consider indicators with both short-term and long-term implications.

174 Laboratory Quality Management System

 15-4: Selecting quality indicators

The laboratory produces much information, but all the things that can be measured
are not necessarily informative. As an example, a computer can analyze data in a
variety of ways, but this does not always mean that the information is useful for
continual improvement activities.

Mark Graham Brown warns, “Many organizations spend thousands of hours

collecting and interpreting data. However many of these hours are nothing more
than wasted time because they analyze the wrong measurements, leading to
inaccurate decision making”.1

Some examples All laboratories should consider implementing a process for using a set of
of quality indicators which cover pre-examination, examination, and post-examination
indicators issues, as well as patient care systems.

A 2005 study of medical laboratories carried out in the United States showed
the most commonly monitored indicators in use at that time were related to
proficiency testing, quality control, personnel competencies, turnaround time, and
patient identification and its accuracy.2

Most common indicators tracked (%), 2005

Patient
identification

Result turnaround
time

Competency
of personnel

Quality
control
Proficiency
testing

40 60 80 100

It is important to note that, ideally, quality indicators used in health care should be
linked to patient outcomes. However, this is very difficult with laboratory indicators
because patient outcome is dependent upon a complex set of circumstances,
including age and underlying illness, stage of illness, stage of diagnosis and stage
of therapy. Therefore, laboratories often use quality indicators other than health
outcomes of patients.

1 Brown MG. Using the right metrics to drive world-class performance. New York, American Management Association, 1996.
2 Hilborne L. Developing a core set of laboratory based quality indicators. Presented at Institute for Quality in Laboratory Medicine
Conference, Centers for Disease Control and Prevention, Atlanta, GA United States, 29 April 2005 (http://cdc.confex.com/cdc/
qlm2005/techprogram/paper_9086.htm).

Laboratory Quality Management System 175

 15-5: Implementing process improvement
Essentials for Regardless of the technique used, continual improvement requires action from
implementation the people within the organization. Some of the necessary steps are important
management roles, and others require the entire laboratory staff for success.
These essential factors and steps include:
 Commitment from all levels of the laboratory staff. Improvement requires
continual awareness and activity. This is a full-time task and requires dedicated
staff time .
 Careful planning so that goals can be achieved. Before action plans are
implemented, there is much to consider: root causes of error; risk management;
failures, potential failures and near misses; costs, benefits and priorities; and the
costs of inaction.
 An organizational structure that supports the improvement activities.
 Leadership—top management must be engaged and supportive.
 Participation and engagement of the people that normally perform the tasks
being addressed.These are the staff most likely to know and understand what is
done on a regular and daily basis, and without their participation, improvement
programmes have little opportunity for lasting success.

Planning When undertaking and implementing action plans for quality improvement, there
for quality are a number of factors to consider.
improvement  What are the root causes of error? In order to correct errors, it is important
to identify the root causes, or underlying causes, of the problem.
 How will risk be managed in the laboratory? Risk management takes into
account the trade offs between the risk of a problem, and the costs and effort
involved in fixing it.
 Failures, potential failures and near misses are categories into which laboratory
problems fall. Failures are most commonly identified, as a failure in the system
will usually be immediately obvious. Failures need to be addressed as a part of
continual improvement. However, a good process improvement programme will
try to identify potential failures, which are not so obvious, as well as near misses
(those situations where a failure has almost occurred).
 Any process improvement programme must take into account the costs of
making changes, the benefits of making the changes and the priorities for action.
These decisions relate to the concept of risk management.
 Finally, it is important to consider the cost of inaction, or failure to take action.
What will be the cost, in money, time or adverse effects, of not correcting a
problem in the laboratory quality system?

Role of leadership Early on, Deming observed that quality managers working without the clear,
active, and open participation of top management cannot succeed in implementing
continual improvement. Sustained leadership must come from the top.

176 Laboratory Quality Management System

 15-5: Implementing process improvement

Good leadership fosters the culture for improvement, including:

 openness—the process must be understood by all and there must be a recognition
that all laboratory staff will have good ideas to help with improvements.
 commitment—it must be clearly communicated that there is support for the
process and that improvements will occur.
 opportunity—a good leader will ensure that all staff have the opportunity to
participate in the process.

Participation in Always remember that top management, quality managers and consultants do
the process not know everything that the bench-level staff know, and often are not aware
of all of the staff’s tasks. It is vital to engage all bench-level staff in the process
improvement programme, as their knowledge and support are also essential.
Furthermore, when staff know they can make a difference, they will benefit the
laboratory by pointing out potential problems that can be avoided.

Continual improvement requires both leadership and engaged team participation.

The following steps show how to plan quality improvement activities:

Quality  use a timeline and do not take on more than can be accomplished within a
improvement timeframe;
activities  use a team approach, involving bench-level staff;
 use appropriate quality improvement tools;
 implement corrective or preventive actions;
 report quality improvement activities, findings and corrective action progress to
management and also to laboratory staff.

2008 2009
ID activity I II III IV I II III IV

1 Specimen collection—haematology
2 ELISA turnaround time
3 Physicians complaints—AFB smears
4 QC of chemistry instruments

If possible, design a study so that results can be statistically measured. Use available
information to select a topic for study, for example:
 customers' suggestions or complaints
 identified errors from occurrence management programme
 problems identified in internal audits.

Consider as a guideline to have no more than one project every six

months.

Retiring a Use a quality indicator only as long as it provides useful information. Once it is
quality indicating a stable and error-free operation, select a new quality indicator.
indicator

Laboratory Quality Management System 177

 15-6: Summary
Continual The process for continual improvement includes:
improvement  identification of the problem;
 analysis of the data and the processes;
 determination of the root cause of the problem;
 generation of ideas for solutions.

The quality cycle

Plan Each step is

essential to keep
the quality cycle
cycling

Act Do

CHECK

Continual improvement is the core of quality management, but it requires

commitment, planning, structure, leadership, participation and engagement.

Key  Quality counts—it is a very important goal for any laboratory.

messages  Continual improvement is an outcome of an active laboratory quality
management system.

178 Laboratory Quality Management System