Medical Laboratory Quality Systems and Accreditation

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Abstract

Nowadays, physicians and public health programme managers are dependent on the technological advancements in health laboratories to make knowledgeable assessments. At the same time, people have continued to demand quality laboratory results. The definition of quality services has been elaborated via the International Organization of Standardization (ISO).

Health laboratories are nowadays required to provide quality service, through the use of quality equipment. This process requires unremitting monitoring and frequent assessment using various evaluation tools.

The World Health Organization has been a strong supporter for the execution and evaluation of quality in health laboratories. The application of Lean thinking in the health care system has been aimed at increasing efficiency, reducing waste and enhancing a united working environment.

Key words

ISO – international Organization of Standardization

WHO – World Health Organization

Accreditation – official identification by a trustworthy body that a laboratory is proficient in conducting its operations.

Lean thinking – Lean thinking is the detection and abolition of waste which allows managers to encourage precision via progressive development

Introduction

Quality management and emphasis on safety in the laboratory is an old concept. The laboratories have been observed to rely on guidance developing organizations, for aid in procedures and accreditation programs. An example of such organizations is the CLSI, formerly referred to as NCCLS. The quality of services provided by a laboratory is dependent on the quality of reagents and equipment used, as well as the suppliers.

The techniques used in quality management have been tried and tested since the period of the great depression, with major developments being noticed in Canada. This development was possible through leadership and establishment of international standards (Guarriello 1997, p 69).

Method

The research was based on various articles, which were selected based on a few factors. These articles used had globally identifiable effects. The material used was also appropriate, in terms of the methodology used to conduct the investigation, the number of subjects in the research, their age and gender, as well as their response rates to the survey.

The literature used was mainly published literature, and academic research, obtained from on-line sources such as PubMed and Embase.

The material obtained was categorized into various sections in order to highlight the problems faced by laboratory Healthcare systems, identify causes and propose remedies, based on Lean thinking. The discussions of statistical data were beneficial in supporting the advantages of Lean thinking in diagnostic laboratories (Ben-Tovim, et al. 2008, p 29).

Laboratory errors

Through various studies conducted to determine the variables that affect the quality of laboratory services, some common factors were found to be the leading causes of unreliable health laboratory services.

Laboratory errors were observed to be a result of understaffing, inadequate attention to detail, poor sample control, poor workload management, poor verification of results, non-validated tests, time pressures and lack of quality control and assessment. These factors were observed to collectively result on poor quality management in health laboratory (Ben-Tovim, Bassham, Bolch, Martin, Dougherty, & Szwarcbord 2007, p 14).

To resolve these issues, the first step was the creation of an agency, such as the International Society for Quality Healthcare. The next step involved the formation of a group to work with. The people necessary for such a venture include industry suppliers to provide equipment, health care providers, the public or patients, recognition agencies, EQA providers and standards development.

The next and final step in the efforts to provide quality management in health laboratories was the creation of a workable system. This system comprised various elements including a clear declaration of policy, enhanced tracking of outcomes, better quality monitoring as well as better awareness of client contentment (Boaden 2006, p 461).

Lean process

The Lean approach originated from fields other than healthcare, though the practises could be properly incorporated into care delivery. Lean Lab involves the identification and abolition of non-value adding activities in a clinical laboratory, based on progressive enhancement using a systematic approach.

Lean lab looks at enhancing safety, improving the response to physicians and patients by enhancing flexibility, decreasing or abolishing wastages of supplies, motion and space, ensuring a steady rate of tests and specimen preparation, maximizing staff responsibilities, reducing expenses by increasing the capacity and minimizing time for analysis, and creating a position for everything, and placing everything at its rightful place (Cooper & Mohabeersingh 2008, p 4).

The main objective of the application of Lean in the laboratory is the delivery of quality patient laboratory results. These results should be satisfactory to the patient, produced at the lowest cost, and released within the shortest time.

Lean looks at process reorganization, change in process management while observing redundant motion, recognizing waste and acknowledging the patient’s view of quality care (Kelly, Bryant, Cox, & Jolley 2007, p 18).

Lean principles

Based on the application of Lean to the clinical laboratory, there were five Lean principles observed. The first principle is value, as perceived by the patient. Value refers to the features that the client pays for, including attention given, quality of service and fast service delivery.

The second principle is value stream. This implies looking at the individual processes for providing medical care and identifying and removing any wastage. The third principle is flow, which implies the uninterrupted provision of a service, in value-adding steps.

The fourth principle is pull, which is beneficial in helping to identify any cause of action, for smooth running of the processes. The final principle is continuous improvement, which places various features under scrutiny, including time, resources and information, necessary to provide quality service to the client (King, Ben-Tovim, & Bassham 2006, p 396).

Lean principles are meant to increase quality, capacity, efficiency and throughput. Concurrently, they should result in reduced cost, inventory, space and time, which are seen in the name given to the process. Other terms used to refer to the Lean process are Business Process Redesign and Operational Effectiveness.

Lean practises incorporate various levels of execution that focus on the client’s treatment progress, the tasks involved in the process and the implementation of tactical operations. Every operation of patient care from admission and diagnosis to discharge requires a good design of the processes, including the expected involvement of various departments.

The Lean principles are effective in providing the guidance to accomplish these processes correctly. The first step in the initiation of Lean projects on medical laboratories is the observation of processes, with a view to identifying any wasteful processes (Long 2003, p 54).

Wasteful processes in laboratories

There is a lot of wastage in waiting for materials, equipment, information and people in laboratory processes, while in preparation. This kind of wastage can be attributed to equipment problems or the push system, where delays can be observed when waiting for the system to be back up, or waiting for samples in a batch to complete testing.

There is also a lot of wastage in the transportation of material or relaying information that has no additional value. The main causes of this are large batches and inefficient workplace layout. Examples of wastage in transportation include moving patients for testing and transferring files and samples between different parties. Over processing of client data also occurs when visual controls are unavailable.

This results in redundant approvals, excess paperwork, unnecessary tests and repetitive data entries. Inventories can also be wasteful when the information available is more than what is needed.

This can be caused by re-stocks and re-orders that are not based on consumption. Examples of this kind of wastage include lab supplies, unused records in the database, paperwork in progress and specimens waiting analysis (Mitchell, 2006).

Wastages in laboratories can also be observed in the movement of people that does not add value to the quality of service provided to a client. Wasteful movement can be a result of ill-planned work areas and non-ergonomic work cell design, leading to time wastage when gathering tools, handling paperwork and finding supplies.

Defective work that contains errors or many mistakes due to poor maintenance of equipment or inaccuracies and omissions in the information provided leads to wastages. Examples of defective work include errors in data entry, wrongful matching of test results and patients and revision of results that compromises the integrity of the samples.

Overproduction refers to the generation of excess information that is not necessary to administer the treatment. Re-prioritization also leads to wastages. This is observed when the tech is interrupted when performing one task, and shifts to another task before completing the previous one.

This is common practise when troubleshooting, or in the occurrence of sudden equipment failure. A common type of wastage that can be blamed on the management is mis-utilization of skills. This can be a result of understaffing, which leads to lack of improvement in the various processes (Mitchell, 2006).

The current system needs to be scrutinized after identifying the wastages in the laboratory process. This process involves following a patient or a sample through the whole treatment process, from examinations to discharge. The people in each work station are also examined, with a view to identifying where value for the patient is created.

Through these studies, wastes can be exposed and documented, by analyzing the time spent in each of the processes. This is a tiring step that is necessary and effective. The third step requires the administration to imagine the future without the wastages. This is a key step in the application of Lean principles as it affects the implementation based on morale and vision (Young & McClean 2008, p 384).

Typical Lean projects

The first step requires the formation of a laboratory team, comprising a supervisor, a lead tech, a skilled Lean leader and a few more people. Administrative support is necessary from the beginning of the project. There is a process matrix to guide the team members. It contains the major performance indicators and baseline measurements.

The team members are trained in Lean thinking, and are progressively informed on the other Lean tools like the flow layout and change management. The process involves mapping the present stage, documenting an ideal state in the future and planning an implementation strategy. Execution of the strategy requires regular re-examining of the process (Young & McClean 2008, p 386).

Common Lean tools

There are some Lean tools that are ever in use, in the laboratory environment. These include simulation, cellular organization, standard work and quality monitoring and work in progress management. Cellular organization refers to physical layout. Lean thinking reduces time wastage by ensuring that many processes are brought closer together to reduce on wastages associated with handing duties over, or work batching.

This is made possible by reducing batching and hand-over points. Work in progress control is also referred to as value stream mapping. This involves following a process from the time it begins till the end, with a view to identifying any wastes. This strategy looks at value adding activities and non value adding activities, in order to reduce the turnaround time (Boaden 2006, p 466).

Quality monitoring involves the investigation of processes to identify working strategies, and the need for change. In the event that changes are made, evaluations are made to ensure considerable similarity to the right way of operation. Changes should be implemented with the aid of training guides. Videos and photos are taken to ensure that variations in the quality of service are identifiable by every person.

Improvements can be made once the work has been standardized. Process simulation involves the creation of a virtual model of a laboratory or process. This is beneficial in that it allows testing without interfering with the ongoing activities. This Lean tool is very effective in understanding the system, as it helps in choosing the most suitable alternative, based on process and staffing alterations (Boaden 2006, p 469).

Conclusion

The application of Lean methodology in the current healthcare environment is necessary due to the increasing population, leading to the requirement for more space in the laboratories. At the same time, the methodology helps to solve the problem of inadequate skilled professionals, by attempting to meet the high expectations set by the clients.

Lean projects have led to smaller batch sizes, better scheduling of samples to staffing schedules, standardization of work processes, better operational tracking management and mistake-proofing to minimize faults resulting from human error (Cooper & Mohabeersingh 2008, p 8).

References

Ben-Tovim, D. I., Bassham, J. E., Bennett, D. M., Dougherty, M. L., Martin, M. A., O’Neill, S. J., et al. (2008). Redesigning care at the Flinders Medical Centre: clinical process redesign using ‘lean thinking’. Med J Aust , 188(6 Suppl), pp 27-31.

Ben-Tovim, D. I., Bassham, J. E., Bolch, D., Martin, M. A., Dougherty, M., & Szwarcbord, M. (2007,). Lean thinking across a hospital: redesigning care at the Flinders Medical Centre. Aust Health Rev , 31, pp 10-15.

Boaden, R. (2006). Quality improvement in healthcare. In: Walshe K, Smith J (eds.). Healthcare Management, pp 454-478.

Cooper, R. G., & Mohabeersingh, C. (2008). Lean thinking for medical practices. JPCCR , 2(1), pp 1-10.

Guarriello, M. L. (1997). Just-in-time in the infrastructure. Hosp Mater Manage Q , 19, pp 68-72.

Kelly, A. M., Bryant, M., Cox, L., & Jolley, D. (2007,). Improving emergency department effi ciency by patient streaming to outcomes-based teams. Aust Health Rev , 31, pp 16-21.

King, D. L., Ben-Tovim, D. I., & Bassham, J. (2006). Redesigning emergency department patient flows: application of Lean Thinking to health care. Emerg Med Australas , 18, pp 391-397.

Long, J. C. (2003). Healthcare Lean. Mich Health Hosp , 39, pp 54-55.

Mitchell, J. D. (2006). Lean thinking for the NHS. London: NHS Confederation.

Young, T. P., & McClean, S. I. (2008). A critical look at Lean Thinking in healthcare. Qual Safe Health Care , 17(5), pp 382-386.

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