Clinical laboratory total quality management (TQM) system
Generally, management can be defined as “an ongoing process that seeks to achieve the objectives of an organization in the most efficient ways possible”.
Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency.
Medical laboratory work is composed of the technical activities that produce laboratory results for patient care and the management activities that support the technical work.
It is the job of the laboratory technical staff to perform pre-analytic activities, analytic activities and post analytic activities that transforms a clinician’s order for a laboratory test.
Clinical laboratory total quality management (TQM) system
M.Sc. Medical Biochemistry
Total Quality management (TQM)
Generally, management can be defined as “an ongoing process that
seeks to achieve the objectives of an organization in the most
efficient ways possible”.
Only sound management of quality in health laboratories will
enable countries to produce test results that the international
community will trust in cases of international emergency.
Medical laboratory work is composed of the technical activities
that produce laboratory results for patient care and the
management activities that support the technical work.
It is the job of the laboratory technical staff to perform pre-
analytic activities, analytic activities and post analytic activities that
transforms a clinician’s order for a laboratory test.
Likewise, it is the job of the laboratory supervisory and
managerial staff to design and implement the supportive
infrastructure that is necessary for the technical work to proceed
An integrated coordinated between technical and managerial
activities are essential for the continuous, unimpeded realization
of high-quality, error-free, efficient, and effective laboratory
Achieving, maintaining and improving accuracy, timeliness and
reliability are major challenges for health laboratories.
When all of the laboratory procedures and processes are
organized into an understandable and workable structure, the
opportunity to ensure that all are appropriately managed is
Laboratory TQM System
In the total quality management system model, all below 12
quality system essentials must be addressed to ensure accurate,
reliable and timely laboratory results, and to have quality
throughout the laboratory operations.
It is important to note that the 12 quality system essentials may be
implementation will vary with the local situation.
Laboratories not implementing a good quality management
system are guaranteed that there will be many errors and
problems occurring that may go undetected.
Implementing a quality management system may not guarantee an
error -free laboratory, but it does yield a high - quality laboratory
that detects errors and prevents them from recurring.
Approaches to implementation will vary with the local situation.
1. Organization :
Organization is one of the essential elements of the quality system, and is
intimately related to all the other elements in the model.
The term organization in the context of a quality management model is
used to indicate the management and the supporting organizational
structure of the laboratory.
The principal element for a successful quality management system is
managerial commitment. These are:
Management at all levels must fully support and actively participate in
the quality system activities.
Support should be visible to staff so that there is an understanding of the
importance of the effort.
Without the engagement of management, including the decision
-making level of the organization, it will not be possible to put in place
the policies and the resources needed to support and laboratory quality
Key organizational components:
Leadership can be defined in many ways, but it is an
important factor in the success of any organization’s efforts
As the laboratory moves from intent to action in the
development of a quality management system, the major
organizational step will be to assign responsibility for
implementation, allocate resources, develop and distribute a
quality manual, being implementation and monitor
compliance with the quality policy and the quality
management system required.
Successful implementation of a quality management system
requires planning management committee, understanding
the benefits, engaging staff at all levels, setting realistic time
frames and looking for ways to continually improve.
Personnel are the most important laboratory resource.
Critical to the implementation of the quality management
system are people who possess integrity, recognize the
importance of their work and participate in continuous
As a laboratorian it is important to:
Participate in training and continuing education
Request training that may be needed as job responsibility
Maintain records of personal professional development.
Success or failure depends on the knowledge and skills of the
people in the laboratory, their commitment and motivation to
perform tasks as described in the job description.
Motivated staffs are more likely to be committed to their work.
Management of personnel is critical to the success of a quality
management programme. Several elements are important in this
Job description should reflect all skills needed and accurately describe
tasks, roles and authorities.
The competency of personnel will need to be evaluated at the time of
hiring and on a regular, recurring basis.
A very important part of the management process is to seek ways to
attract qualified personnel and to provide motivation and appropriate
benefits and working conditions so as to retain staff.
Personnel are most crucial resources in the laboratory so managers must
create an environment that will fully support all laboratory personnel in
order to maintain a high quality of laboratory performance.
Continuing education is vital to personnel competency, but doesn't need
to be expensive.
New testing methodologies and instruments are constantly introduced
to the marketplace, and employees need to be update their knowledge
Many kinds of equipment are in used in the laboratory, and
each must be functioning properly.
Proper management of the equipment in the laboratory is
necessary to ensure accurate, reliable and timely testing.
The benefits of a good equipment management programme
Helps to maintain a high level of laboratory performance.
Lengthens instruments life
Increases safety for workers
Produces greater customer satisfaction.
A great deal of thought and planning should go into
equipment management. These includes:
Selection and purchasing
Calibration and performance evaluation
Service and repair
Retiring and disposing of equipment.
All laboratories should have a well organised equipment
programme. The programme should address equipment selection,
preventive maintenance and procedures for troubleshooting and
A good equipment maintenance programmes results in a high
level of performance and greater confidence in the reliability of
A significant benefit to the laboratory will be fewer interruptions
in test performance, low repair cost and elimination of premature
replacement of equipment.
Day-to-day maintenance should be the responsibility of the
technical operator. Everyone who uses the equipment should be
trained in calibration and daily maintenance.
4.Purchasing and inventory:
Purchasing and inventory management is a critical and essential
component of the quality management system.
Careful management of inventory helps to prevent waste, which
can occur if reagents and supplies are stored improperly or if,
reagents become outdated before they can be used.
Establishing a purchasing and inventory management programme
will ensure that :
Supplies and reagents are always available when needed.
High quality reagents are obtained at an appropriate cost.
It is very important to set expectations and build and maintain
relationships with providers of materials and services.
Laboratories that purchase directly should look very carefully at
vendors and manufacturer's qualifications, examine such things as
specifications and method of transport.
Successful purchasing and inventory management requires that
policies and procedures be established for maintaining all critical
materials and services.
Properly managed inventory will:
Ensure that patient and clinical needs are met.
Ensure products are available when they are needed.
Increase the efficiency and effectiveness of the laboratory, because
it will provide an uninterrupted flow of needed materials.
5.Process control (quality
Process control is comprised of pre-analytical, analytical and
post analytical factors that are important in ensuring the
quality of the laboratory testing processes.
These factors include quality control for testing, appropriate
management of the sample, including collection and
handling, and method verification and validation.
Laboratory quality can be defined as accuracy, reliability and
timeless of reported test results.
The laboratory must have good samples in order to ensure
accuracy and reliability of testing and confidence in results.
Quality control is the part of quality management focused on
fulfilling quality requirements.
Simply, it is examining “control” materials of known
substances along with patient's sample to monitor the
accuracy and precision of the complete analytic process.
QC monitors activities related to the examination phase of
testing. The goal of QC is to detect, evaluate, and correct
errors due to test system failure, environmental conditions
or operator performance, before patients results are
The quality of the work a laboratory produces is only as good
as the quality of the samples it uses for testing.
The laboratory must be proactive in ensuring that the
samples it receives meet all of the requirements for
producing accurate test results.
Written policies for sample management must be established
and reflected in the laboratory handbook. Components to be
Information needed on requisition or forms
Handling urgent request
Collection, labelling, preservation and transport.
Evaluating, processing and tracking samples.
Storage, retention and disposal.
Collection and preservation:
The collection of appropriate and optimum samples is the
responsibility of the laboratory, even though the actual
collection process is often carried out by persons who are not
part of the laboratory staff.
Essential information for the test request form
Time and date of sample collection
Clinical data, when indicated
Verification of quality:
Once a sample enters the laboratory, there are a number of
steps needed prior to testing.
Verify the sample is properly labelled, adequate in quantity,
in good conditions and appropriate for the test request
Record sample information into a register or log.
Enforce procedures for handling sub optimum samples,
including sample rejection when necessary.
Rejection of sample: the following sample should be
Broken or leak tube or containers
Inadequate volume for quantity of preservative
Insufficient quantity for the test required.
Non-fasting samples, for tests that requires fasting
Sample collected in wrong tube / container
Prolong transport time or other poor handling.
The register should includes:
Date and time of collection.
Date and time the samples was received in laboratory.
Tests to be performed.
Diagnostics test results
Time band date of results reported.
Elements of a QC programme:
Regardless of the type of examination that is performed, step
for implementing and maintaining a QC programme include:
Establishing written policies and procedures, including
Training all laboratory staff
Ensuring complete documentation.
Reviewing quality control data
Different QC procedures are applied to monitor
quantitative, qualitatively and semi-quantitative tests.
6. Information management:
Information management is a system that incorporates all the
processes needed for effectively managing data - both
incoming and outgoing patient’s information.
The information management system may be entirely paper-
based, computer based, or a combination of both.
Laboratory directors need to ensure that the laboratory has
an effective information management system in place in
order to achieve, confidentiality and privacy of patients
When planning and developing an information management
system, whether it is manual, paper-based or an electronic
system, there are some important elements to consider :
Unique identifiers for patients and sample.
Standardized test result forms.
Logs and worksheet
Checking processes to assure accuracy of data recording and
Protection against loss of data
Protection of patient confidentiality and privacy
Effective reporting system
Effective and timely communication
The laboratory should carefully consider potential problem and plan
on how to avoid them. Some of the common problems are:
Incomplete data for test interpretation, or insufficient or illegible
Forms that are inadequately designed to meet laboratory and clients
Standardized forms prepared by others that may not be suitable for
Inability to retrieve data due to poor archiving processes or
insufficient backup of computerized information.
Poor data organization, which may hinder later data analysis efforts to
meet research or other needs.
Incompatibility between computerized information system and
equipment or other electronic system, resulting in problem with data
A good information management system will :
Ensure that all data- the final product of the laboratory is well managed.
Consider all the ways laboratory data will be used when planning a
Ensure the accessibility, accuracy, timeliness and security of data.
Ensure confidentiality and privacy of patient information.
7. Documents and records:
Documents include written policies, processes and procedures and
provide a framework for the quality system. They need to be updated
Records include information captured in the process of performing
and reporting a laboratory test. This information is permanent and
doesn't require updating.
Documents include all the written policies, process and procedures of
In order to develop laboratory document it is important to understand
each of these elements and how they relate to each other.
Characteristics of documents are that they:
Communicate information to all persons who need it, including
laboratory staff, users and laboratory management personnel.
Need to be updated or maintained.
Must be changed when a policy, process or procedure changes
Establish formats for recording and reporting information by
the use of standardized forms- once the forms are used to
record information, they become records.
Some eg: of document includes a quality manual,
standard operating procedure and job aids.
Documents are reflection of the laboratory's organization and it's quality
A well - managed laboratory will always have a strong set of documents
to guide its work.
Some of the important documents that every laboratory should have
Quality manual - this is the overall guiding document for the quality
system and provides the framework for it's design and implementation.
SOPs - contains step-by-step written instructions for each procedures to
perform consistently by everyone in laboratory.
Reference materials - as an ex: photographs and descriptive information
can no very helpful.
Characteristics of records are:
Need to be easily retrieved or accessed.
Contain information that is permanent and are not revised or
modified and doesn't require updating.
Records are laboratory information, either written by hand or
They should be complete, legible and carefully maintained, as
they are used for many purposes. Some of them are:
Tracking of samples
Many kinds of records are produced in a laboratory. Some eg
Sample logbook or register
Laboratory workbooks / worksheet
Quality control data
Instrument printout- maintenance records
Patients test report
Results of internal and external audits.
Continuous improvement projects
User surveys and customers feedback.
Storing documents and records:
Storage must be given careful consideration, as the main goal of
documentation is finding the information when it is necessary. By using paper
or an electronic system. These include :
Having a good document control programme ensures that the most current
version of a document is used, and ensures availability and ease of access when
a document is needed.
Records must be meticulously maintained so as to be accurate and accessible.
Note: Documents and records are essential for accuracy, and consistency in the
8. Occurrence management:
An occurrence is an error or an event that should not have
happened. A system is needed to detect these problems or
occurrence to handle them properly, and to learn from
mistakes and take action so that they don't happen again.
An occurrence is any event that has a negative impact on an
organization, including it's personnel, the product of the
organization, equipment or the environment in which it's
operates. All such events must be addressed in an occurrence
Occurrence management is a central part of continual
It is the process by which errors or near errors are identified
The goal of an occurrence management programme is to
correct the errors in either testing or communication that
results from an event, and to change the process so that the
errors are unlikely to happen again.
There are many other sources of errors, which are frequently
observed. Errors can occur throughout the testing process.
Collecting the wrong sample
Mislabeling or failing to label the sample.
Storing the sample inappropriately, causing sample
Damaging the reagents or test kits by storing them
Transporting the sample under conditions that damages the
sample or endanger the staff and public safety.
Making transcription error when preparing the report.
Sending the report to the wrong location, this often results
in complete loss of the report.
Consequences of laboratory errors:
Inadequate or inappropriate patients care.
Inappropriate public health actions
Wasting of resources
Undetectable communicable disease outbreaks.
Death of an individual.
Occurrence management process:
Establish a process to detect all problems, using the tools that
Keep a log of all problems event that record the error, any
investigation activities and any actions taken.
Investigate the cause of any problem that is detected and
carefully analysed the information that is available.
Take the necessary action, if the problem is detected before
the error actually occurs, take preventive action.
Providing information to all those who need it, and to those
who are affected by the error.
The responsibility for monitoring for occurrence belongs to
everyone in the laboratory.
It is important however, that someone be designated as the
person responsible for marshalling the energies and activities
of all staff into an effective management process.
The laboratory should employ an active process for
occurrence management and take a positive approach.
Make an effort to detect problems as early as possible, and
then take immediate remedial and corrective action.
An assessment can be defined as the systematic examination of some
part of the quality management system to demonstrate to all concerned
that the laboratory is meeting regulatory, accreditation and customer
The process of assessment is a tool for examining laboratory
performance and comparing it to standards, benchmarks or the
performance of other laboratories.
Assessment may be internal audit (performed within the laboratory
using it's own staff) or it may be external audit (conducted by a group
or agency outside the laboratory ).
Laboratory quality standards are an important part of the assessment
process, serving as benchmarks for the laboratory.
Central - level laboratories are generally familiar with
assessment processes, as most will have had some kind of
assessment by an external audit.
A laboratory needs this information about it's performance
Planning and implementing the quality system.
Monitoring effectiveness of the quality system
Correcting any deficiencies that are identified
Working towards continuous improvement.
Assessment is important in monitoring the effectiveness of
the laboratory quality management system.
Both external and internal audits yield useful information.
Audits are used to identify problems in the laboratory, in
order to improve processes and procedures.
An outcome of assessment is finding root cause of problems
and taking corrective actions.
All laboratories should establish an internal audit programme
conducted on a regular basis, it will provide information for
Problems become opportunities for improvement.
10. Process improvement:
A process is a series or operations contributing to an end.
Process improvement, one of the 12 quality system essential,
establishes a programme for helping to ensure continual
improvement in laboratory quality over time.
The primary goal in a quality management system is
continuous improvement of the laboratory processes and this
must be done in a systematic manner.
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
A very similar set of activities for achieving continual
improvement in the laboratory are described. These
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.
The process for continual improvement includes :
Identification of the problem.
Analysis of the data and the processes.
Determination of the root cause of the problem.
Generation of ideas for solution.
Continual improvement is the core of quality management, but
it requires commitment, planning structure, leadership,
participation and engagement.
Quality counts - it is very important goal for any laboratory.
Continual improvement is an outcome of an active laboratory
quality management system.
Quality indicators are information that is measured. These
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.
11. Customer service:
Customer satisfaction is a major component of a quality
management system. If The customer is not well served, the
laboratory is not achieving it's primary function.
Good customer service provides:
Valuable information for best patient care.
Valuable information to improve surveillance and other
public health actions.
A professional image for the laboratory.
The concept of customer service has often been overlooked in
laboratory practices. However, it is important to note that the
laboratory is a service organization; therefore, it is essential that
clients of the laboratory receive what they need.
The laboratory should understand who the customers are, and
should assess their needs and use customer feedback for making
Customer service is an integral part of a quality management
When necessary customer satisfaction, whether by survey,
indicators or audits, much will be learned when the method is
Seeking customer satisfaction requires commitment from the
laboratory management and staff. It is important to
remember that technical competency is not the only goal for
A programme for addressing customer satisfaction requires
good planning, the development of appropriate monitoring
tools, and the knowledge to apply the tools to gain useable
Monitoring customer satisfaction requires some resources,
primarily involving staff time. Managers need to ensure that
these resources are available.
12. Facilities and safety:
Laboratory work space and facilities must be such that the
workload can be performed without compromising the
quality of work and the safety of the laboratory staff, other
health care personnel, patients and the community.
A laboratory safety programme is important in order to
protect the lives of employees and patients, to protect
laboratory equipment and to protect the environment and
ultimately to protect the world.
Many factors must be a part of the quality management of
facilities and safety. These includes:
Service - This is the process of preventing unwanted risks
and hazards from entering the laboratory space.
Containment - which seeks to minimize risks and prevent
hazards from leaving the laboratory space and causing harm to
Safety - This includes policies and procedures to prevent
harm to workers, visitors and the community.
Ergonomics - This addresses facility and equipment
adaptation to allow safe and healthy working conditions at the
As a quality manager, it is necessary to:
Develop a complete and through description of basic safety
rules and organization, and ensure that personnel are trained
in their specific duties when new activities or techniques are
introduced into the laboratory.
Know the basic safety and biosafety management issues when
working with chemicals and pathogens of low level or
Know how to perform on extensive risks assessment when
developing new activities in the laboratory.
Conduct laboratory safety audits.
As a laboratorian, it is important to:
Be aware of basic safety rules and processes
Understand the basic safety and biosafety management issues
when working with toxic chemistry, biological samples and
physical hazards and when interacting with patients.
The safety officer should be assigned responsibility for
ensuring that there is an adequate supply of appropriate
equipment for safety and biosafety, such as:
Fire extinguishers and fire blankets
Appropriate storage and cabinets for flammable and toxic
Eyes washers and emergency shower
Waste disposal supplies and equipment.
First aid equipment.
Personal protective equipment:
Hand protection – gloves
Face protection - goggles, masks
Body protection - apron
If laboratory personnel becomes contaminated with biological
hazards due to splashes or splits, immediate steps to take includes :
Clean exposed skin or body surfaces with soap and water , eyewash (
for eye exposure ) or saline ( for mouth exposure )
Apply first aid and treat as an emergency
Notify supervisors, safety officers, or security desk
Follow appropriate reporting procedures
Report to physician for treatment or counseling.