Tapeshwar Yadav

(Lecturer)BMLT, DNHE, M.Sc. Medical Biochemistry

Clinical Laboratory Total Quality management

(TQM) System

Introduction: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.

Contd…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 unimpeded.

An integrated coordinated between technical and managerial activities are essential for the continuous, unimpeded realization of high-quality, error-free, efficient, and effective laboratory operations.

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 increased.

Laboratory TQM System model: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.

TQM System Model

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 management system.

Contd…Key organizational components:Leadership Organizational structure Planning processImplementation Monitoring Leadership can be defined in many ways,

but it is an important factor in the success of any organization’s efforts for improvement.

Contd… 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.

2. Personnel: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 improvement.

As a laboratorian it is important to:Participate in training and continuing education

opportunities. Request training that may be needed as job

responsibility increases Maintain records of personal professional

development.

Contd…Personal policies:EthicsConfidentiality Employee benefits Work schedules.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 management process.

Contd… 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 and skills.

3. Equipment: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 are:

Helps to maintain a high level of laboratory performance.

Lengthens instruments lifeIncreases safety for workers Produces greater customer satisfaction.

Contd…A great deal of thought and planning

should go into equipment management. These includes:

Selection and purchasing Installation Calibration and performance evaluation Maintenance Trouble shooting Service and repairRetiring and disposing of equipment.

Contd…All laboratories should have a well organised

equipment programme. The programme should address equipment selection, preventive maintenance and procedures for troubleshooting and repairs.

A good equipment maintenance programmes results in a high level of performance and greater confidence in the reliability of results.

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.

Contd…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 control):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.

Contd…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 reported.

Contd…Sample management 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 addressed include:

Information needed on requisition or forms

Contd…Handling urgent request Collection, labelling, preservation and transport.Safety practices 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.

Contd…Essential information for the test

request form includes:Patient's identification Test requested Time and date of sample collection Clinical data, when indicated

Contd…Sample processing 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.

Contd…Rejection of sample: the following sample

should be rejected :Unlabelled sample Broken or leak tube or containers Hemolysed samplesInadequate volume for quantity of preservative Insufficient quantity for the test required. Non-fasting samples, for tests that requires

fastingSample collected in wrong tube / container Prolong transport time or other poor handling.

Contd…The register should includes:Date and time of collection.Date and time the samples was received in

laboratory.Sample typeTests to be performed.Diagnostics test results Time band date of results reported.

Contd… 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 corrective action.

Training all laboratory staffEnsuring complete documentation. Reviewing quality control dataDifferent 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 information.

Contd…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 transmission Protection against loss of data Protection of patient confidentiality and privacy Effective reporting system Effective and timely communication

Contd…Common problems 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 identification

Forms that are inadequately designed to meet laboratory and clients need

Standardized forms prepared by others that may not be suitable for all laboratories.

Inability to retrieve data due to poor archiving processes or insufficient backup of computerized information.

Contd…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 transmission.

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 system. 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 and maintained.

Records include information captured in the process of performing and reporting a laboratory test. This information is permanent and doesn't require updating.

Documents: Documents include all the written policies, process and

procedures of the laboratory. In order to develop laboratory document it is important

to understand each of these elements and how they relate to each other.

Contd…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

changesEstablish 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.

Contd…Documents are reflection of the laboratory's organization and

it's quality management. 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 includes: 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.

Contd…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 computer -printed.They should be complete, legible and carefully

maintained, as they are used for many purposes. Some of them are:

Continuous monitoringTracking of samples Evaluating problems Management

Contd…Many kinds of records are produced in a

laboratory. Some eg includes:Sample logbook or register Laboratory workbooks / worksheet Quality control dataInstrument printout- maintenance records Patients test report Results of internal and external audits.Continuous improvement projects User surveys and customers feedback.

Contd…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 :

Permanence Accessibility Security Traceability 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 laboratory.

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 management programme.

Occurrence management is a central part of continual improvement.

Contd…It is the process by which errors or near errors are

identified and handled. 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. These includes:

Collecting the wrong sampleMislabeling or failing to label the sample.

Contd…Storing the sample inappropriately, causing

sample deteriorates. Damaging the reagents or test kits by storing

them improperly. 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.

Contd…Consequences of laboratory errors: Inadequate or inappropriate patients care.Inappropriate public health actions Wasting of resources Undetectable communicable disease

outbreaks. Death of an individual.

Contd…Occurrence management process: Establish a process to detect all problems, using the

tools that are available. 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.

Contd…Responsibilities: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.

9. Assessment: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 requirements.

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.

Contd…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 for:

Planning and implementing the quality system.

Monitoring effectiveness of the quality system Correcting any deficiencies that are identified Working towards continuous improvement.

Contd…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 continual improvement.

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 problems.

Contd…A very similar set of activities for achieving

continual improvement in the laboratory are described. These includes:

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.

Contd…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.

Contd…Quality indicators are information that is

measured. These 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.

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.

Contd…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 improvement.

Customer service is an integral part of a quality management system.

When necessary customer satisfaction, whether by survey, indicators or audits, much will be learned when the method is successful.

Contd…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 the laboratory.

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 information.

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.

Contd…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 the community.

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 laboratory site.

Contd…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 moderate risks.

Know how to perform on extensive risks assessment when developing new activities in the laboratory.

Conduct laboratory safety audits.

Contd…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.

Contd…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 chemicalsEyes washers and emergency showerWaste disposal supplies and equipment. First aid equipment.

Contd…Personal protective equipment: Hand protection – glovesFace protection - goggles, masksBody protection - apronIf 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 deskFollow appropriate reporting procedures Report to physician for treatment or counseling.

THANK YOU!!!