Quality Indicators And Quality Management System

Published Date: 02 Nov 2017

Quality Indicators and Quality Management System in Clinical Biochemistry Laboratory

Biomedical sciences Year 3

Samoisy Jean Hubert

Literature Review

When talking to others about Quality, we must be sure that we have the same understanding of the term. Quality has different definitions, according to different dictionaries:

A degree of excellence-The concise Oxford Dictionary

Fitness for purpose- Defoe and Juran (2010)

The totality of features and characteristics that bear on the ability of a product or service to satisfy a given need- British Standard Institution;1991

The total composite product and service characteristics of marketing, engineering, manufacture and maintenance through which a product or service will meet the expectations of the customers- Feigenbaum (1961)

Conformations to requirements- Crosby (1979)

Quality is a dynamic state associated with products, services, people, processes and environment that meets or exceeds expectations and helps produce superior value- Goetsch and Davis (2010) [1] 

Feigenbaum’s (1961) [2] definition of Quality is one of the most interesting, as it brings into consideration departments other than manufacturing which contribute to the quality of the product and service provided by the company to meet the expectations of the customer. But the best definition comes from Goetsch and Davis as their definition draw together the themes of a number of definitions of quality, creating a unifying definition. The most noteworthy addition to previous discussion is the idea of dynamism. By this, they mean that acceptable levels of Quality are not fixed, but change with customers’ experiences and view of the world. Form Goetsch and Davis definition, it can be concluded that:

Quality is defined by the customer, and such will change over time, often in unpredictable ways.

Quality is associated with creating customer value.

A quality service meets or exceeds the whole range of customer expectations.

As a complex concept quality can only be addressed by the whole organization working together. [3] 

According to Graeme Kwoles (2011), if ‘Quality’ is the end point, then ‘Quality Management’ is the approach and process for getting there. Accordingly, we need to develop an appropriate understanding of what this idea means. In this context there is no simple definition which encapsulates the area; instead we need key principle to the topic need to be considered. There are a number of principles which are central to Quality Management:

Customer focus: if we wish to create value for customers we need to understand the customers and their requirements or expectation.

Strategic focus: Quality Management must be a strategic undertaking. If companies survive and thrive through delivering value to their customers, then they must treat this as a key strategic objective, creating a strategic vision and deploying this throughout the company in associated goals and actions. This implies a long term commitment and focus.

Leadership focus: Nothing happens in any organization without commitment of leaders and their active driving of the strategy, and their constant engagement.

Process focus: For too long, many organizations have been obsessed with outcomes. Outcomes are driven the effective application of appropriate processes. Emphasis needs to move from assessment of outcomes performance to the development and control of process to deliver customer value.

People focus: Quality management is fundamentally about people. Processes are only effective in delivering customer value if they are associated with appropriate behaviours from the individuals involved. An excellent process can be let down or demotivated by poorly trained member of staff. An important aspect of managing quality if the creation of a motivated and empowered workforce able to work with and on processes to maximize customer value

Scientific focus: Quality management is fundamentally based on the scientific method- Plan, Do, Study, Act- where decision are evaluated based on evidence and data, and these evaluations are, in turn, used to drive further interactions for action. This is supported by appropriated use of analytical tools to derive maximum information from the data available.

Continual improvement, innovation and learning: At the heart of Quality Management is the dissatisfaction with the status quo. Process improvement is not simply about responding to the problems, it is about proactively seeking to learn about customers, processes and behaviours; and to improve upon existing practices. [4] 

Total Quality Management (TQM) is a sub-discipline of management science which aims to define, set, control and improve the effectiveness of an organisation within its constraints. It has been named and labelled by different nomenclatures in its evolution over the last 60 years or so, such as quality control (QC), quality assurance (QA), total

Quality control (TQC), Company-Wide Quality control (CWQC), TQM, or quality management systems (QMS).

Medical Laboratory testing and services have an important role in the provision of health care and in utilization and reimbursement. Assessing the quality of laboratory services using quality indicators or performance measures requires a systematic, transparent, and consistent approach to collecting and analysing data. A comprehensive approach would address all stages of the laboratory total testing process, with a focus on the areas considered most likely to have important consequences on patient care and health outcomes. Quality indicator data should be collected over time to identify, correct, and continuously monitor problems and improve performance and patient safety by identifying and implementing effective interventions and for the purpose of increased consistency and standardization of key processes among clinical laboratories. Certain laboratory medicine quality indicators have been advocated for use as internal quality assessment tools. Based on the Institute of Medicine (IOM) definition of quality of care as "the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge, a quality indicator is a tool that enables the user to quantify the quality of a selected aspect of care by comparing it with a criterion [5] . A quality indicator may be defined as an objective measure that evaluates critical health care domains as defined by the IOM (patient safety, effectiveness, equity, patient-centeredness, timeliness, and efficiency), is based on evidence associated with those domains, and can be implemented in a consistent and comparable manner across settings and over time.

For this reasons, there has been immergence of quality monitoring organizations which provide consensus, standards and guidelines for the health care community. Some of these organizations include: The World’s Health Organization (WHO), Clinical and Laboratory Standards Institute (CLSI), The International Organization for Standardization (ISO), The National Institute for Standards and Technology (NIST), National Committee on Clinical Laboratory Standards (NCCLS), International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), International Union for Pure and Applied Chemistry (IUPAC). [6] These organizations are affiliated with many countries and organizations, which work together to find out ways of "improving what we are doing for patients" and to develop a formal consensus process for standardization. The quality monitoring organizations after consensus discussions with their respective partners provide documents in the form of:

Standards which are developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified.

Guidelines are developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs.

Reports are documents that have not been subjected to consensus review and are released by the Board of Directors or recognized Science Journals.

Rationale

As mentioned by V. Benigno, B. Lindstrom, L. Sarti (2001), the concept of quality was developed in the industrial age and was initially identified solely with product quality control (verification). This remained the case throughout the 19th century and for most of the 20th. It was not until after World War II, and especially during in the sixties thanks to the work of Juran, that the idea of Total Quality became widespread.

Total Quality embraces the modern concept of quality. It seeks to minimize errors and dysfunction in the production cycle: planning, production, maintenance, etc. With Total Quality, the focus shifts away from detection of product defects to evaluation of all the phases of production. The concept behind TQ is this: final product control does not add quality; rather, quality is to be built up step by step throughout the whole production cycle.

According to the modern concept of quality, a product need not necessarily be something tangible, it may also be something intangible such as the delivery of a service.

The total quality of products, goods and services embraces a variety of elements. The importance of traditional quality control within these does not overshadow other controls or evaluations related to the whole production cycle. Careful quality control will obviously not compensate for product shortcomings arising from design faults. In turn, design cannot be efficient if carried out by poorly trained staff using unsuitable tools.

In short, quality represents a fundamental approach for satisfying customers. It leads to a new way of managing organizations, including clinical laboratories. Underpinning quality is the principle of global efficiency based on getting things right the first time. This is a new, more wide-ranging way of achieving quality, one that affects every aspect and process of the organization [7] 

Methodology

This paper is a critical review of the published articles, guidelines or reports from Laboratory Standardization Organizations. The following articles were reviewed and analysed:

ISO 9001, (2008), Quality Management System-Requirements

ISO 15189, (2003), Medical laboratories-Particular requirements for quality and competence

NCCLS HS-A2, (2004), Quality Management System Model for Health Care Approved Guidelines

Pre-analytical errors in hospitals Implications for quality improvement of blood sample collection, Ollof Wallin, (2008)

ISO 9000, (2005), Quality Management System-Fundamentals

GP26-A3, (2003), Quality Management System-A model for Laboratory Services.

International Standardisation Organisation’s main products are international standards. ISO also publishes technical reports, technical specifications, publicly available specifications and guides technical. Technical reports are issued when a technical committee or subcommittee has collected data of a different kind from that normally published as an International Standard. Technical specifications can be produced when "the subject in question is still under development or where for any other reason there is the future but not immediate possibility of an agreement to publish an International Standard". [8] Â Publicly Available Specifications may be "an intermediate specification, published prior to the development of a full International Standard.

ISO sometimes issues technical corrigenda. Corrigenda (plural of corrigendum) are amendments to existing standards because of minor technical flaws, usability improvements, or limited applicability extensions. Generally, these are issued with the expectation that the affected standard will be updated or withdrawn at its next scheduled review.

A standard published by ISO is the last stage of a long process that commonly starts with the proposal of new work within a committee.

International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a process with six steps:

Stage 1: Proposal stage

Stage 2: Preparatory stage

Stage 3: Committee stage

Stage 4: Enquiry stage

Stage 5: Approval stage

Stage 6: Publication stage [9] 

The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders [10] while meeting statutory and regulatory requirements related to the product. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principle on which the family of standards is based [11] . ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfil.

ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards: ISO 9000:2005 Quality management systems — Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach. Only ISO 9001 is directly audited against for third party assessment purposes. The other two standards are supplementary and contain deeper information on how to sustain and improve quality management systems; they are therefore not used directly during third party assessment. Outline contents for ISO 9001 are as follows:

Pages 1 to 14: Requirements

Section 1: Scope

Section 2: Normative Reference

Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)

Section 4: Quality Management System

Section 5: Management Responsibility

Section 6: Resource Management

Section 7: Product Realization

Section 8: Measurement, analysis and improvement

GP26-A3 (Quality Management System-A model for Laboratory Services) and NCCLS HS-A2, (Quality Management System Model for Health Care Approved Guidelines) are guidelines, derived from ISO 9001. They are both available on Clinical and Laboratory standard Institute official website http://www.clsi.org. These two guidelines are a bit more specific to Laboratories than ISO 9001

ISO 15189 Medical laboratories — Particular requirements for quality and competence, specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardisations’ Technical Committee. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff. While the standard is based on ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

ISO 9000 (2005), ISO 9001 (2008) and ISO 15189 (2003), GP26-A3, (2003), NCCLS HS-A2, have been chosen for this met analysis for the following reasons:

Create a more efficient, effective operation

Increases customer satisfaction and retention

Improves employee motivation, awareness, and morale

Reduce operation costs, reduce waste and increases productivity

Promotes good quality management practices

The Quality Management System

In the present environment of limited resources, quality cannot be taken for granted by those who fund, receive, and provide healthcare services. However, the burgeoning awareness of the horrific personal and economic impact of medical errors on patient safety has focused a national spotlight on quality management in healthcare services. Our historic perspective of quality control and quality assurance as defining quality needs to be superseded by a more global view of internationally accepted quality activities applied to a given scope of work.

According to ISO 9001, (2008) [12] , the adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by:

its organizational environment, changes in that environment, and the risks associated with that environment,

its varying needs,

its particular objectives,

the products it provides,

the processes it employs,

Its size and organizational structure.

A Quality Management System as described by NCCLS HS-A2 (2004) [13] as a set of key ‘quality elements’ that must be in place for an organization’s work operation to function in a manner to meet the organization’s stated quality objectives. The increasing complexity of today’s healthcare services emphasizes the need for a systematic approach that both promotes and provides the best quality services to patients and improves patient’s safety. Many guidelines, including ISO 9001 and NCCLS HS1-A2 have characterized the fundamental ‘quality elements’ as the Quality System Essentials (QSEs). The quality management system model proposed by the International Standardization Organization (ISO) and the National Committee on Clinical Laboratory Standards (NCCLS) describe 12 Quality System Essentials and also describes how they are related to health care management systems. These QSEs are listed and outlined below:

Organization

Describes key leadership responsibilities that are integral to laboratory success, quality planning and integration of the Quality Management System

Facilities and safety

The healthcare organization must provide and maintain a safe work environment for employees, patients and visitors in compliance with all applicable standards rules and regulation.

Personnel

Laboratories require clearly defined jobs qualification, job description. It also involves proper selection, orientation and training of the personnel. They may also be subjected to continuous competency assessment and performance development plans in order to maintain and retain highly qualified personnel.

Equipment

The laboratory should state the quality expectations for the equipment that is used during experimental processes. In addition, the manufacturer’s instructions for calibration, maintenance and use of the equipment must be clearly stated, and must follow any regulation and accreditation requirements. Special processes for using and troubleshooting equipment together with maintenance facilities are also required.

Purchasing and Inventory

Critical supplies and services must be identified and criteria for quality must be established with the vendors. It also describes any agreements between laboratory and entities to which it provides services, as well with those from which it obtains products and services. Process for purchasing, receiving the purchased items and managing inventory must be in place

Process control

Each discipline must identify and define all processes and its operation. For each step in the process, well written procedures that are easily understood and applied by the staffs are keys for ensuring consistency in performance. The laboratory should use appropriate control measures to detect errors and process controls to prevent errors.

Information Management

Provides guidance for managing information generated and entered into paper based or electronic systems and disseminated to users or other computer systems. Includes planning of processes to improve and ensure confidentiality of information

Document and Records

Documents include written policies, process descriptions, procedure and blank forms

Records are the completed worksheets, forms, labels…that capture the information obtained from any activities performed, including results.

Both documents and records need to be properly managed and archived

Occurrence Management

Capture and analyse information to identify systematic problems, determines problems origin, causes and corrective measure to the problem.

Assessment

Assessment of quality is essential to achieving it. Participating in external and scheduled internal audits ensures that the quality system is meeting stated requirements. Quality indicators must be identified and monitored for all operation and actions must be taken when unacceptable performance is demonstrated.

Customer Service

The laboratory should be committed to providing a quality service by meeting customer expectations. External or internal services satisfaction can be measured and the feedback given on the basis of findings.

Process Improvement

Once the system is in place, there is a need for continuous improvement. Sources of information for improvement include: Customer feedback, internal audits, occurrence analysis, external assessments, literature reviews… [14] The ISO 9001 is quite a good and precise guideline for achieving quality in an organization. For this reason, many organizations have adopted the way of thinking of International Standardization Organization.

Somehow, concerning medical biochemical laboratory, the ISO 9001 looks of some precision in its guideline, ISO 9001 (2008) deals mainly with organization management system, whereas the medical biochemical laboratory will have to deal with a more complex problem; patient lives. In medical biochemical laboratory what seem to be a simple error to others can cause great impact on patient treatment, and improper treatment sometimes may lead to death.

Treating patient’s (human) specimen for clinical is therefore a complex process. But with proper management system, the complex process can be made simpler and more efficient. But the most important in medical biochemical laboratory is to be able to give a precise and accurate result.

In addition to the quality system essential of ISO 9001 (2008), medical biochemical laboratory should have implemented other quality system essentials. These essentials can be found in another guideline published by International Standard Organization, the ISO15189 (2003).

Firstly, the medical biochemical laboratory should possess clear and define documents for preventive actions. These preventive actions are needed for improvement and identification in potential sources of non-conformities either technical or concerning the quality system. Following the preventive actions, action plans shall be developed implemented and monitored to reduce the occurrence of such unconformities and therefore to take advantage of the opportunities for improvement procedures for preventive actions and application of control to ensure their effectiveness. Preventive actions might also involve analysis of data including trend and risk analyses. Preventive action is a pro-active process for identifying opportunities for improvement rather than a reaction to the identification of problems or complaints. [15] 

Furthermore, the ISO15189 (2003) mentions a technical requirement, ‘Accommodation and Environmental Conditions’ [16] . The laboratory shall have space allocated so that its workload can be performed without compromising the quality of work, quality control procedures, and safety of personnel or patient care services. The laboratory director shall determine the adequacy of this space. The resources shall be of a degree necessary to support the activities of the laboratory. Laboratory resources shall be maintained in a functional and reliable condition. Similar provisions should be made for primary sample collection and examinations at sites other than the permanent laboratory facility. The laboratory shall be designed for the efficiency of its operation, to optimize the comfort of its occupants and to minimize the risk of injury and occupational illness. Patients, employees and visitors shall be protected from recognized hazards. Laboratory facilities for examination should allow correct performance of examinations. These include, but are not limited to, energy sources, lighting, ventilation, water, waste and refuse disposal, and environmental conditions. The laboratory should have procedures for checking that the environment does not adversely affect the performance of specimen collection and equipment.

According to Ollof Wallin, (2008) [17] from Umea University, the management system of medical biochemical laboratory shall also take into account the total testing process. The total testing process is the total process from the ordering of a test to the interpretation of the test result. The total testing process can be sub divided into 3 distinctive phases:

The pre-analytical step (before analysis)

The analytical step (the actual analysis)

The post analytical step (after analysis)

He also said that errors can occur in any step of TTP which can give rise to problems such as delayed test results; renewed sampled collections; improper diagnosis and treatment which can lead to coma or even death.

For analysis in medical biochemical laboratory, the most common biological sample type is venous blood samples, which are usually collected by puncture of the antecupital vein by a needle connected to an evacuated test-tube or syringe. At this stage point of venous blood collection, there can be pre-analytical errors. These pre-analytical errors are largely attributed to human mistakes since the pre-analytical phase evolves much more human handling. The first point of care at this stage is the patient identification and test-tube labelling. Mistakes in identification and labelling procedures in blood testing can result in serious adverse events.

Errors can also arise in sample collection. One common error during sample collection is improper position of the patient during and before venous blood collection. This can allow escape of fluid into interstitial space, thus, components such as protein that cannot pass the vessel wall will increase in concentration while freely passing constituents such as electrolytes will have a lower concentration. One other important source of the pre-analytical is incomplete or incorrect information [18] .

The last pre-analytical source is delayed transport of blood sample from the site of collection to the laboratories. Prolonged transport time causes delayed patient care and can also allow unwanted biochemical reaction within the test tube to occur (blood lysis, glycolysis or bacterial proliferation). To prevent these pre-examination errors, the laboratory management shall provide standard operative procedures to hospital wards or Out Patient Department so as to decrease the impact of pre-examination procedures. According to ISO15189 (2003), pre-analytical SOP’s shall include the following:

Proper procedures for proper filling of request forms with information which will allow identification of the patient; clinical information relevant to the patient; date and time of collection of the sample. On the same request form, the laboratory technician shall have a space to note the date and time of reception of the sample.

Specific instructions for proper collection and handling of sample shall be documented and implemented by laboratory management and made available to those responsible for sample collection. These instructions shall be published as a "sample collection manual". The manual shall include the following:

List of available laboratory examinations offered

Types of tubes (anti-coagulants) to be used for each test (type and amount to be collected)

Consent form

Procedures for preparation of the patient

Instructions for completion of request forms

Any special handling needs between time of collection and time received by laboratory

Instructions for labelling of primary sample

Instructions for disposal of materials used in the collection.

Majority of the errors in the total testing process come from the pre-analytical phase. But errors also arise in the analytical and post analytical phase. Of all errors in the total testing process, 7-13% has been reported to occur in the analytical phase and 19-47% has been reported in the post-analytical phase.

Errors in analytical can either be systematic or random. Random errors in experimental measurements are caused by unknown and unpredictable changes in the experiment. These changes may occur in the measuring instruments or in the environmental conditions. Example of causes of random errors is electronic noise in the circuit of an electrical instrument. Random errors often have a Gaussian normal distribution, and thus can be eliminated by statistical methods, by taking several test results and calculating their mean.

In the other hand, Systematic errors in experimental observations usually come from the measuring instruments. There are two types of systematic errors:

Zero error in which the instrument does not read zero when the quantity to be measured is zero.

Scale error in which the instrument consistently reads changes in the quantity to be measured greater or less than the actual changes

Over years, biomedical scientists have developed techniques to eliminate analytical errors. The two main ways to eliminate errors are:

Proficiency testing

To further reduce analytical errors, personal of the biochemistry laboratory shall be provided with standard operating procedures which are guidelines that explain step by step the procedures to follow during analytical testing. Instead of SOP’s, card files or similar systems, that summarize key information of the analytical procedure can also be used as a quick reference at the world bench.

The Standard Operating Procedure shall compromise of the following:

The purpose of a test

The principle behind the procedures

Performance specification (linearity, precision, analytical sensitivity and analytical specificity of the test)

Type of sample to be used (e.g. plasma, urine etc.)

Required equipment and reagents

Calibration procedures

Step by step procedures of the test

Control procedures

Principle for calculating and validating results

Safety precautions.

Quality control programs

It is the process for monitoring the quality of laboratory testing, and accuracy and precision of the results. The main objectives of a Quality Control Program are:

Risk prevention

To detect deviations

Error corrections

Improve efficiency

Quality control includes the establishment of a quality standard or specifications for each aspect of the testing procedure, determination of how close to the quality standard the testing procedure is, and then taking any necessary corrective actions to bring the procedures up to the required standard. In practice, internal quality control is designed to check that a laboratory will produce the same result or outcome if the test or procedure is done on different occasions (within-laboratory variation), or by different technicians (Philip L.matson Quality control, quality assurance and IVF, 2008)

Quality control can be of two types:

Internal Quality Control

It involves the ‘In house Procedures’ for continuous monitoring of operations and systematic day to day checking of the produced data to decide whether these are reliable enough to be validated and reported. The procedures primarily monitor the bias of data with the help of control samples and the precision by means of duplicate analyses of test samples and/or of control samples. For IQC, the same sample is analysed twice during an assay and the outcome is noted and compared. Results should be identical if no errors exist. The main aim of Internal Quality Control is to ensure Repeatability (when the same sample is analysed twice by the same person with the same instruments) and Reproducibility (when the sample is analysed under varying conditions, for instance when the analyses are performed at different times, by different persons, with different instruments).

External Quality control

Participation within a recognized external quality assurance (EQA) scheme has many benefits, including information on the relative performance of different methods, and knowledge about one's own ability to perform tests and report results. The concerned laboratory is provides with vials of controls without reference values for analysis under the conditions of that lab. The results obtained are to be sent to the reference laboratory for verification. External Quality Control is most useful for to assess the closeness of results to the actual value (accuracy). [19] 

According to ISO/IEC 17025 (2003), the laboratory shall have quality control procedures for monitoring the validity of tests undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. The monitoring shall include e.g. regular use of internal quality control. Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported. Internal quality control at the chemical analytical laboratory, involves a continuous, critical evaluation of the laboratory’s own analytical methods and working routines. The control encompasses the analytical process starting with the sample entering the laboratory and ending with the analytical report. Somehow, only HÃ¥vard Hovind , Bertil Magnusson , Mikael Krysell Ulla Lund,Irma Mäkinen, (2011) [20] , reported that when a quality control (QC) program is established, it is essential to have in mind the requirement on the analytical results and for what purposes the analytical results is to produce ‘ the concept of fit for purpose’. The requirement for a proper Quality Control program involves the following:

Type of QC sample

Type of QC chart

Control limits – warning and action limits

Control frequency

Different control samples

Ideally the control samples should go through the whole measurement procedure. They should also be very similar to test samples and stable over time. There should also be a sufficient amount for years and a suitable analyte concentration. This is however seldom the case and therefore we use several types of control samples:

Certified Reference Material (external laboratories)

Reference material, standard solution or in-house material

Blank sample

Test sample [21] 

Types of Quality Control charts

As mentioned by HÃ¥vard Hovind et al. (2011, p15-16), control charting is a powerful and a simple tool for the daily quality control of routine analytical work. The basis is that the laboratory runs control samples together with the routine samples in an analytical run. Material of control samples can be standard solutions, real test samples, blank samples, in-house control materials and certified reference materials.

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X-charts

An X-chart has a central line, upper and lower warning limits and upper and lower action limits. One of the oldest and simplest types of control chart is the X-chart, which is based on the distribution of the control values around a true or expected value. It can be used to monitor the combination of systematic and random effects for control values, based on single results or on a mean of multiple analyses. Using a reference material similar to a routine sample as control sample, the bias may be monitored by comparing the mean control value over time with the reference value.

The blank value chart is a special application of the X chart based on analysing a sample that can be assumed to contain the analyte at a very low level. It provides special information about contamination of the reagents used, and the state of the measurement system. Even though concentrations are normally entered into the blank value chart, it is also possible to use the value of the measured signal. Remember that both positive and negative control values shall be plotted in the chart. In ideal cases the zero value should be the central line. However, the empirical mean value can be also used as the central line. Another special case is a recovery chart. The analytical process may be tested for matrix influences by determining the recovery of spiked additions of standards to test samples. In this case a recovery rate of 100 % should be the central line. Calibration parameters such as slope and intercept, in so far they are determined daily, can also be monitored by means of the X chart.

Range charts

A range chart (R, r%) has a central line, an upper warning limit and an upper action limit. The X-chart shows how well control values (mean values of multiple analyses or single values) are within control limits. In contrast the range chart serves above all the purpose of repeatability control. The range is defined as the difference between the largest and smallest single result for two or more separate samples. For practical applications in analytical laboratories the R chart mostly appears only in its simplest form, only duplicate determination (of samples to be analysed) in each analysis series.

The best samples to be used are test samples selected among the samples to be analysed in that analytical run. However the concentrations may vary, because the samples are different in every analytical run. The range is normally proportional to sample concentration (at levels well above the detection limit) and then it will be more appropriate to use a control chart where the control value is the relative range r %.

If, for test samples, single determinations are made, the control value for the range chart should be based on the difference between single determinations of two (or more) different sample aliquots. If on the other hand, test samples are run in duplicate Håvard Hovind et al. (2011,p). Internal Quality Controll – Handbook for Chemical Laboratories, recommend that the control value is based on the mean value of duplicated determinations of two different sample aliquots – i.e. the same number of measurements for routine test samples as for control samples.

Levey-Jennings Chart

Levey Jenning chart is a graph whereby control values are plotted versus time. It consists of a line graph for each data point, an average line and upper and lower control limit lines at 3 standard deviation lines from centre line. The distance of the control values from the mean is measured in standard deviation. Standard deviation is a statistic that quantifies how close numerical values (i.e., QC values) are in relation to each other.

A trend indicates a gradual loss of reliability in the test system. Trends are usually subtle. Causes of trending may include:

Deterioration of the instrument light source

Gradual accumulation of debris in sample/reagent tubing

Gradual accumulation of debris on electrode surfaces

Aging of reagents

Gradual deterioration of control materials

Gradual deterioration of incubation chamber temperature (enzymes only)

Gradual deterioration of light filter integrity

Gradual deterioration of calibration

Abrupt changes in the control mean are defined as shifts. Shifts in QC data represent a sudden and dramatic positive or negative change in test system performance. Shifts may be caused by:

Sudden failure or change in the light source

Change in reagent formulation

Change of reagent lot

Major instrument maintenance

Sudden change in incubation temperature (enzymes only)

Change in room temperature or humidity

Failure in the sampling system

Failure in reagent dispense system

Inaccurate calibration/recalibration

Frequency of control analyses

Generally, as a minimum, one control sample in each analytical run must be analysed for detecting possible systematic effects within the analytical run, for example from calibration. Stability of the measurement system can have an influence on the frequency of control analyses. If there are errors caused by calibration drift, the number of control samples to be analysed in each analytical run may need to be higher than under very stable measurement conditions. The principle guiding the decision on the number of times a control sample must be analysed in each analytical run is that all measurements performed after the last approved sample in the quality control may have to be reanalysed. The frequency of control is therefore a balance between the cost of the control and the cost of repeating analyses.

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Results and Conclusion

Quality and continuous improvement have become an intrinsic part of the activities in health sciences, especially in Clinical Biochemistry.

The goals and objectives of the Quality Management Program are:

To provide patients with the best services in terms of reliability

To improve the quality of medical and behavioural health care and service provided to

Members through administrative simplification and a comprehensive and on-going system of monitoring measurable performance indicators (including indicators based on high-volume, high-risk, and problem-prone services, data from customer satisfaction surveys, complaints/occurrences, and appeals, and other relevant sources), evaluating results relative to established goals and benchmarks, and acting to promote improvement

To identify, develop, and/or enhance activities that promote both staff and personnel safety and encourage a reduction in medical errors.

To ensure a network of qualified personnel and providers by: proper training and work specific training.

To promote communication between local and external laboratories about quality activities, providing feedback on results of plan-wide and practice-specific performance assessments, and collaboratively developing improvement plans

To ensure that the quality of care and service delivered by delegates meet standards established by local laboratory management and relevant regulatory agencies, and that delegates maintain continuous, appropriate, and effective quality improvement programs through on-going oversight activities and regular performance assessments

To document and report the results of monitoring activities, barrier analyses, recommendations for improvement activities, and other program activities to the appropriate committees

To comply with all regulatory requirements, to achieve and maintain accreditation, and necessary certification

To ensure that the appropriate resources are available to support the QM Program

Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation and identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other interested parties.

Reviewing all these articles has allowed me to accustom myself with the Quality Management System in healthcare, and more specifically in Clinical Biochemistry.

This has drawn me to the conclusion that not all the Quality Management Systems can be used to run and manage a clinical biochemistry laboratory.

One example is the ISO 9001 standard, which is widely used in manufacturing and service organisations to evaluate their system for managing the quality of their product or service. Certification of an organisation’s quality management system against ISO 9001 confirms the compliance of the management system to this standard. The GP26-A3, (2003) and NCCLS HS-A2, (2004) are two standard guidelines that have been written, by different organisations, but both have used the same principles and guidelines as ISO 9001. They tend to concentrate more on Quality essentials of the Quality management system. This causes them to have the same problem as ISO 9001, with standardisation of Clinical Biochemistry, which is lack of specificity. They tend to generalise their guidelines. This is therefore inappropriate for clinical Biochemistry management, just because in healthcare system, the main aim of the management is not only to increase general work efficiency, as mentioned by ISO 9001, but to provide accurate results, for the right patient within a meaningful timeframe as regards clinical management, using appropriate laboratory procedures and with a respect for ethics, confidentiality and the safety of the patient.

To demonstrate the quality and reliability of their services, medical laboratories can refer themselves to ISO 15189: Medical laboratories – Particular requirements for quality and competence, an internationally recognised standard that contains the requirements necessary for diagnostic laboratories to demonstrate their competence to deliver reliable services. ISO 15189 covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid test or "examination" results as they are known in the standard. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is for the use of medical laboratories in developing their management systems and maintaining their own competence; and for accreditation bodies to confirm or recognise the competence of these laboratories through accreditation.

ISO 15189 is based on ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) and ISO 9001 (Quality management systems – Requirements). It therefore incorporates the quality systems elements addressed in ISO 9001 certification, as well as the general requirements of a testing laboratory. Somehow, what makes ISO 15189 really specific to clinical biochemistry laboratory is the addition of 5 criteria for medical laboratories. This includes:

Providing advice on the type of sample, and testing that may be required;

Interacting with clinical staff by placing a responsibility on the laboratory to liaise with

Clinicians who refer patient samples for testing about the quality of their service;

Providing opinions on results of testing in relation to diagnosis and patient care collecting samples or if not, providing information on collection procedures, sample containers and sample volumes

Ethical practice – first duty is to the patient, not to the ‘customer

That’s not all about quality management system. One of the most important key factors in QMS, for any clinical biochemistry laboratory is to ensure continued compliance, continual improvement and continual assessment. Accredited laboratories are regularly reassessed to check that they are maintaining their standards of technical expertise. These laboratories will also be required to participate in regular proficiency testing programs (known as external quality assurance programs or EQAS) as an on-going demonstration of their competence. In this field, the Quality Control– Handbook for Chemical Laboratories, reviewed in this met analysis provides the best guidelines for Internal/External Quality Control. It concentrates on all that concerns Quality control, types of samples used in Quality Control, and most importantly on the types of charts used in Quality Control.

Conclusion

In a nutshell, therefore, it has been seen through this review that no standard guideline written up to now has been able to satisfy the Total Quality Management System required to fully run a Clinical Biochemistry Laboratory. It is also noted that several reports/guidelines bring different, but good ideas. Therefore, a seen in this review, a combination of ISO 15189 with Quality Control– Handbook for Chemical Laboratories shall give the best Quality Indicators Standards for the Clinical Biochemistry.