Implementation of ISO 9001 in a medical testing laboratory

 The Department of Clinical Chemistry and Molecular Genetics, within the Institute of Clinical Pathology and Medical Research at Westmead Hospital, is a medical testing laboratory operating within the public sector health system of New South Wales, Australia. It provides acute-care pathology services to Westmead Hospital (a 900-bed tertiary referral university teaching hospital) as well as to three district hospitals and three rural hospitals. In addition to these core clinical chemistry services, it offers approximately 150 specialised biochemistry, pharmacology, toxicology, trace metal and molecular genetics assays as a reference laboratory service. In 1993, the Department became Australia's first medical testing laboratory to be registered to ISO 9001-1987/AS3901-1987. In 1995, this certification was extended to AS/NZS ISO 9001-1994. We are currently preparing for further accreditation to ISO/IEC Guide 25-1990, with additional supplementary requirements for medical testing. This paper describes the Quality System that the Department developed and which has been successfully maintained and extended since original certification. Important features of the Quality System are: 1. Primary design of the Quality System to meet medical and customer needs, with subsequent addition of required ISO elements. 2. Use of national Quality Award criteria to identify key business processes. 3. Development of integrated technical non-conformance, customer complaint, staff suggestion, and quality system corrective action procedures. 4. Implementation without external resources. Our conclusions are that ISO 9000 Quality Systems can be applied to medical testing laboratories, and can be implemented with minimum resource costs. Improvements in technical and service quality and business performance have resulted from this process. However, implementation of ISO 9000 at the level of individual Departments is not ideal. Greater improvements are possible when this process is undertaken at the level of the entire organisation. Received: 9 September 1996 Accepted: 5 October 1996     

Is it safe to have a laboratory test?

A recent US Institute of Medicine report indicated that up to 98,000 deaths and more than 1 million injuries occur each year in the United States due to medical errors. These include diagnostic errors, such as an error or delay in diagnosis, failure to employ indicated tests and the use of outmoded tests. Laboratory tests provide up to 80% of the information used by physicians to make important medical decisions, therefore it is important to determine how often laboratory testing mistakes occur, whether they cause patient harm, where they are most likely to occur in the testing process, and how to prevent them from occurring. A review of the literature and a US Quality Institute Conference in 2003 indicates that errors in laboratory medicine occur most often in the pre-analytical and post-analytical steps in the testing process, but most of the quality improvement efforts focus on improving the analytical process. Measures must be developed and employed to reduce the potential for mistakes in laboratory medicine, including better indicators for the quality of laboratory service. Users of laboratory services must be linked with the laboratorys information system to assist them with decisions about test ordering, patient preparation, and test interpretation. Quality assessment efforts need to be expanded beyond external quality assessment programs to encompass the detection of non-analytical mistakes and improving communication between the users of and providers of laboratory services. The actual number of mistakes in laboratory testing is not fully recognized, because no widespread process is in place to either determine how often mistakes occur or to systematically eliminate sources of error. We also tend to focus on mistakes that result in adverse events, not the near misses that cause no observable harm. The users of laboratory services must become aware of where testing mistakes can occur and actively participate in designing processes to prevent mistakes. Most importantly, healthcare institutions need to adopt a culture of safety, which is implemented at all levels of the organization. This includes establishing closer links between providers of laboratory services and others in the healthcare delivery system. This was the theme of a 2003 Quality Institute Conference aimed at making the laboratory a key partner in patient safety. Plans to create a permanent public–private partnership, called the Institute for Quality in Laboratory Medicine, whose mission is to promote improvements in the use of laboratory tests and laboratory services are underway.Presented at the 9th Conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium.     

Towards quality specifications in extra-analytical phases of laboratory services: What information on quality specifications should be communicated to clinicians, and how?

Quality specifications, the level of performance required to facilitate clinical decision-making, not only have a central role in quality management in clinical laboratories, but are also essential for assuring the interpretation and utilization of laboratory information by clinicians. Laboratory tests have been grouped into five categories and the most suitable ways to communicate quality specifications to clinicians have been proposed. In particular, for tests with a uni-modal distribution, decision limits should replace the traditional reference values. For tests with a bi-modal distribution, in addition to reference values, some flags based on the uncertainty of laboratory data, can be included in the report. For tests used in patients monitoring and in evaluating the response to therapy, the reference change value or the most effective threshold of the difference between two consecutive results should be indicated. For tests/test batteries that require interpretative comments, these should be added on a regular basis. Lastly, pre- and post-test counseling is mandatory for genetic testing.Presented at Quality 2005, 10th Anniversary Meeting in Antwerp, Belgium March 7th–8th, 2005.     

Fitness for purpose in relation to specification limits

Frequently, the ultimate goal of an analytical measurement is to assess compliance in respect to a specification limit. So, the necessary requirement is to make a correct decision on the grounds of the measurement result. It is suggested a practical methodology to attain fitness for purpose results when specification limits are established for compliance assessment. It is based on a comparison between fitness for purpose uncertainty functions that define a high probability of conclusive correct decisions and a characteristic uncertainty function which describes the performance of the analytical system along concentration in a given condition of measurement. To attain fitness for purpose results, different replication programs are applied. Determinations of Zn, Mn and Cd in potable water are discussed as case studies. They represent different cases concerning relative position of detection and specification limits. A definition of fitness for purpose when specification limits are relevant is given. Quality of analytical results and analytical procedures should be associated with the concept of fitness for purpose.     

Predictive values instead of normal ranges: less data, more information

Diagnostic strategies can have various goals at two levels: to facilitate the diagnostic process on the cognitive level, and to serve considerations on the level of the doctor–patient relationship. Requests for laboratory tests could be intended to exclude a disease or to affirm the presence of disease. Thirdly, tactical motives to smoothen the negotiations between doctor and patient probably seem to be important as well. These three intentions differ in prior probability, should lead to different sets of tests, and to different interpretations. Even the cut-off points should differ. This leads to three different decision strategies, both at requesting, as at interpreting the results. Following this line of thought, post-test probabilities are more suitable than normal ranges. Excluding strategy: this is the most prevalent. However, the disadvantage of an excluding strategy (prior 1–5%) is a false-positive result. A positive test result should lead to follow-up by wait and see or by repeated testing. More extensive testing usually is not a very sensible strategy. In practice, physicians simply ignore slightly abnormal values. Mentally they put the cut-off points for normality more broader. The number of tests is small. Confirmative strategy: the disadvantage of a confirmative intention (prior 10–30%) is a false-negative result. Follow-up without testing, repeated testing, or even accepting marginal normal results as abnormal is a proper strategy. The number of tests is moderate to high. Tactical strategy: the tactical intention strategy to reassure the patient – or avoid referrals – could lead to ignoring all slightly positive test results by choosing a higher cut-off point. Actually, considering the usual insignificant diagnostic gain when testing for tactical reasons, all test results are clinically insignificant, unsuspected outliers excluded. Here, a very limited set of tests should be chosen. The laboratory test is the currency in mutual trading medical expectations and relationship considerations between doctor and patient. The number of tests is minimal. If the physician chooses a strategy, a limited range of prior probability is chosen. Then a possibly computerized algorithm produces a “Value (posterior probability)” as test result, replacing “Value (normal ranges)”. Thus one number less on the lab form, yielding more significant information.Presented at the 10th Conference Quality in the Spotlight, March 2005, Antwerp, Belgium     

Homogeneity testing of reference materials

 Homogeneity testing is of the highest importance for the certification of reference materials, as it should demonstrate the validity of the certified values and their uncertainties in the analysis of individual units or portions thereof. However, the conclusions drawn from the results of these studies may often be questioned. It is proposed to improve this situation by quantifying the effect of homogeneity studies in terms of their impact on the uncertainty of certified values. Here it should be noted that the between-units variability directly affects the certified uncertainty, whereas the within-unit inhomogeneity only defines the minimum representative test portion. Received: 18 September 1997 · Accepted: 21 November 1997     

The impact of measurement uncertainty on the producer’s and user’s risks, on classification and conformity assessment: an example based on tests on some construction products

The reliability of test results and subsequent classification statements or product certification depend on the variability of the product’s properties and on the validity of the test procedures used. With an emphasis on measurement uncertainty, producer’s and user’s risks as well as probabilities of conformance, conformity and classification are calculated exemplarily for two requirements for mineral aggregates used in construction. An important methodological basis is an international draft document on measurement uncertainty in conformity assessment. The mathematical instruments given are applied and further developed to a risk scenario for product classification. The results from a classification point of view show that the reliability of test results for acid-soluble sulphates is mostly acceptable and both the producer’s and user’s risks are quite small. In contrast, the magnesium sulphate index test produces results which are hardly usable for classification and certification purposes or for risk management in production. Product certification bodies should generally have an appropriate approach when dealing with results where precision data are poor.     

Implementation of ISO 9002 for research in occupational epidemiology

 The Department of Epidemiology, which forms part of the French National Institute for Research and Safety (INRS), is involved in research on occupational risks. It provides results of industry-based epidemiological studies focused on the relationship between occupational exposure and diseases of the respiratory system, central and peripheral nervous systems and cancer. This paper describes the Quality Assurance System developed by our department, which has been successfully maintained and extended since being granted ISO 9002 certification by the French Association for Quality Assurance. The quality system includes procedures specific to epidemiological study conduct and scientific peer reviews. It has been designed in order to meet the required ISO elements, including quality aims and policy, quality procedures for management of personnel, sub-contractors and facilities, nonconformities, corrective and preventive actions, archiving and traceability and planning of internal quality audits. Improvements in management, technical and service quality have resulted from this process. Although epidemiological studies differ markedly from industrial production for which the standards were originally drawn up, we have found that Quality Assurance is both applicable and useful in epidemiological research on occupational risks. Therefore, we conclude that a certified Quality Assurance Scheme including scientific peer reviews can be recommended to ensure reliable epidemiological results. Received: 22 July 1998 · Accepted: 5 October 1998     

Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong

This paper proposes an innovative concept for robustness evaluation guided by two crucial aims: indubitable identification of the factors that significantly affect the LC method and avoidance of unnecessary time and money wasting. The first phase of the proposed strategy includes robustness screening during the method optimization. Initial assumptions of the method robustness can be tracked as the rate of the response change while the factors deviate within the expected range. Therefore, partial and total robustness criteria are calculated. If the results obtained are not satisfactory, re-optimization of the method should be considered. Otherwise, extensive robustness testing defined by experimental design and multi-level factors estimation should be performed to confirm the method robustness. Firstly, the important factors are investigated by the standard graphical (normal probability plots) and statistical (algorithm of Dong and error estimation based on a priori declared negligible effects) procedures. Since these approaches have several drawbacks, they can result in the appearance of false negative or false positive results. Thus, the modification of the statistical tests is advised in order to make the final conclusions. Special attention was dedicated to the advantages of the adapted algorithm of Dong (so-called 75 % approach) in the absence of the effect sparsity. The new approach is presented on the optimization and robustness testing of LC method for determination of ramipril and its five impurities. It is proved that the proposed strategy can perform an overall robustness estimation and successfully reveal all important factors.     

Surveys on the accreditation of providers of proficiency testing and external quality assessment schemes

Two surveys among providers of proficiency testing (PT) and external quality assessment (EQA) schemes were carried out during 2004 and 2005. The main objectives were to explore the current status of accreditation/certification and collect the providers’ views. Information based on the response from 160 providers in 32 countries reveals a strong tendency towards accreditation of PT/EQA. It is shown that this type of accreditation is based on several combinations of normative documents, hence illustrating a lack of harmonisation of national accreditation bodies. The surveys also show that schemes are operated under considerably different conditions and that providers’ competence may or may not be underpinned by other certification and/or accreditation. This paper elaborates on a number of issues related to PT/EQA accreditation, including customers’ views, normative documents, providers’ experience from the accreditation process, views expressed by international organisations, and effects of accreditation on participation fees, quality and availability.     

The Slovak National Accreditation System

 After the split of the Czechoslovak Federation, the Slovak National Accreditation System was established in November 1993, being the only system in this country executing accreditation and certification. This system is strictly based on EN 45 000 and covers testing laboratories from both the mandatory and voluntary areas of metrological laboratories, products testing and certification, quality systems, and good laboratory practice. It seeks to reach the level of compatibility accepted and recognized by EU member countries. The development and basic features of the Slovak National Accreditation System, its basic principles, and the structure and competence of accreditation bodies are described in this article.     

A quality systems approach for identifying and controlling sources of error with point of care testing devices

Historically, due to the size and nature of the instrumentation, highly skilled laboratory professionals performed clinical testing in centralized laboratories. Today’s clinicians demand realtime test data at the point of care. This has led to a new generation of compact, portable instruments permitting ”laboratory” testing to be performed at or near the patient’s bedside by nonlaboratory workers who are unfamiliar with testing practices. Poorly controlled testing processes leading to poor quality test results are an insidious problem facing point of care testing today. Manufacturers are addressing this issue through instrument design. Providers of clinical test results, regardless of location, working with manufacturers and regulators must create and manage complete test systems that eliminate or minimize sources of error. The National Committee for Clinical Laboratory Standards (NCCLS) in its EP18 guideline, ”Quality management for unit-use testing,” has developed a quality management system approach specifically for test devices used for point of care testing (POCT). Simply stated, EP18 utilizes a ”sources of error” matrix to identify and address potential errors that can impact the test result. The key is the quality systems approach where all stakeholders – professionals, manufacturers and regulators – collaboratively seek ways to manage errors and ensure quality. We illustrate the use of one quality systems approach, EP18, as a means to advance the quality of test results at point of care. Received: 26 June, 2002 Accepted: 17 July 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Abbreviations NCCLS National Committee for Clinical Laboratory Standards (formerly) · POCT point of care testing · QC quality control · HACCP hazard analysis critical control points · CLIA clinical laboratory improvement amendments (of 1988) Correspondence to S. S. Ehrmeyer     

Development of a reference material for residues of chlorfluazuron and fluazuron in beef fat ACSL CRM 3

The certification by interlaboratory testing of a candidate reference material (ACSL CRM 3) for the concentration (mass fraction) of the pesticides chlorfluazuron (CFZ) and fluazuron (FZN) is described. The certification process was based on a two-stage nested design described in ISO Guide 35. Analysis of results reported by collaborating laboratories provided an assessment of the homogeneity of the RM. The certified values were chlorfluazuron -1.01 mg/kg and fluazuron -1.02 mg/kg. The upper and lower 95% confidence limits for CFZ and FZN were calculated to be: CFZ upper=1.05 mg/kg, lower=0.97 mg/kg; FZN upper=1.08 mg/kg, lower=0.95 mg/kg. A certificate was prepared according to guidelines set out in ISO Guide 31.     

Remembering the Stockholm Consensus

Last year marked the tenth anniversary of the conference Strategies to Set Global Quality Specifications in Laboratory Medicine, which was held in Stockholm. The main outcome of this conference was a hierarchy of models to set metrological requirements, commonly known as the Stockholm Consensus. Belief in the appropriateness and scientific rigour of this Consensus has since been disseminated around the world. The Stockholm Consensus has made the biological variation model the model that is most commonly used to set metrological requirements. However, this model is not objective, because it is based on the selection of the one of three multiplication factors that reflects the mean biological variation. In addition to this lack of objectivity and other weaknesses of the biological variation model, the so-called Stockholm Consensus was not a true consensus process. Since our knowledge of this field continues to grow, the setting of metrological requirements should be a matter of true consensus based on the state of the art, rather than a “pseudo-objective” process. Metrological requirements should ensure that clinical laboratories do not produce measurement results that are less precise than their measuring systems allow.     

The process of management review

Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000 standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness, and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources, etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are taken that improve the effectiveness of the quality-management system. As output from the management review process, there should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements; corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the processes involved and using the process approach in the management review ensures the continual improvement of the quality system. Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium.     

A proficiency testing scheme to evaluate the effectiveness of laboratory sample reduction of a soil sample

Accreditation and Quality Assurance - Although proficiency testing (PT) schemes in analytical chemistry are intended to test the entire analytical process, the reality is that some aspects of the...     

European Quality Promotion Policy for improving the competitiveness of european industry

 The Community legislative policy for the free movement of industrial goods has evolved from an approach based purely on legislation and public intervention towards a more voluntary approach based on a homogeneous system combining regulatory and voluntary assessment of conformity with standards and/or customer specifications. This has led to an increased participation of the economic operators in the legislative process and a better reallocation of responsibilities between the public and private sectors. The European Union has now to go beyond legislation, standardisation and certification, in order to contribute further to increasing the competitiveness of European industry. At present, Community activities concentrate on reinforcing the Single Market and the necessary quality infrastructures, and in the proper implementation of existing legislation, in particular the application and interpretation of the CE marking requirements. These measures, however, do not solve all the problems relating either to conformity with regulatory requirements or to enhancing competitiveness. The European Quality Promotion Policy has the ambition of constituting above all an awareness policy to give political visibility and support to a European-wide range of quality instruments and actions. Simultaneously, it should be seen as a logical step on the road from conformity with safety regulations (in particular CE marking directives) to competitiveness and business excellence through quality management strategies.     

Certification of reference materials for inorganic trace analysis: the INCT approach

This paper presents the work done by the Institute of Nuclear Chemistry and Technology (INCT), Warsaw on a procedure of the certification of matrix reference materials (CRMs) for inorganic trace analysis. The INCT has been involved in preparation and certification of that type of CRMs since 1986 till now. The certification of CRMs is performed on the basis of statistical evaluation of the data obtained from the worldwide interlaboratory comparison. The initially adopted certification procedure has been developed, and the final shape is presented and discussed. The modifications are connected with the new demands of the international standards. The results of analysis of candidate CRMs obtained by the potentially primary procedures based on radiochemical neutron activation analysis (RNAA) and results of analysis of CRM accompanying candidate RMs are applied in the certification process for quality assurance purpose.     

The German perspective of using the EFQM model in medical laboratories

The financial resources of health care services are only nominally growing in Germany. Therefore, the politicians have been forced to act. Up to now, a fixed limit of remuneration should not affect the quality of patient management. However, these primary economic issues have initiated positive and negative reactions from the laboratory medicine community. In hospital laboratories the challenge is to realise continuous improvement of service quality but at the same time reduce costs. This can only be achieved by introducing total quality management (TQM) and measuring the quality obtained by the European Foundation for Quality Management (EFQM) model. Predominantly formal attempts to improve quality at the level of ”enablers” such as certification (ISO 9000) or accreditation (EN 45000, ISO 15189) will not solve these problems. Two groups in Germany work on TQM and EFQM: the Working Group ”Laboratory Management” of the German, Austrian and Swiss Societies for Laboratory Medicine and for Clinical Chemistry, and the Institute for Quality Management in Medical Laboratories (INQUAM). Their work has resulted in several books on the subject, successful propagation of application of the EFQM model and a proposal for a formalized ”certification” procedure according to the model.     

The use of uncertainty estimates of test results in comparisons with acceptance limits

When a test is performed in order to qualify a material or a product for a certain use, the result is generally compared with an acceptance limit. The test result has an uncertainty which should be estimated and stated (e.g. in accordance with GUM). Very often this is not the case. Further, discussions often arise on the issue of how the uncertainty shall be considered in relationship to the acceptance limit. The intention of this note is to describe, in simple terms, the statistical background and to give some recommendations. In short, there are two clean-cut, extreme situations. The first case is when the uncertainty of the testing procedure is the dominating factor. Here it is found that the estimates of single laboratories cannot, generally, be used for comparisons with acceptance limits. One should have standardised, well-verified estimates based on comprehensive investigations of the method. It can also be concluded that comparisons between test results and acceptance limits have to be made with regard to the actual circumstances, as, e.g. how the acceptance limit is related to the risk. In the second case, the variation in the property of the material or product dominates and the uncertainty of the testing procedure is negligible. When the results are non-quantitative (go – no go), statistical methods can be used to estimate the risk taken with a certain sampling and acceptance strategy that a certain proportion of the batch to be delivered does not qualify. This should be considered more often in standardisation of product test methods. When the results are quantitative, a statistical analysis should be performed and the uncertainty should be compared with the acceptance limit as before, from the actual circumstances. When effects of testing uncertainty and product variation are comparable a sound treatment requires extensive experimental work. No short cuts can be made without loss of confidence! Received: 17 August 2001 Accepted: 21 March 2002