THE QUALITY MANAGEMENT IN HEALTH CARE. A TWENTY YEARS JOURNEY.

Ulises Ruiz, University Institute for Healthcare Assessment, Madrid Complutense University, Spain. José Simon, University Institute for Healthcare Assessment, Madrid Complutense University, Spain.

ABSTRACT

Along the past century quality management in health care has been an increasingly important consideration for health care providers, health care financiers, health care consumers and politicians.

In recent years, driven by increasing legislation, consumers awareness and media interest, patient safety has become a crucial issue for health care systems management in developed countries. Many different approaches for managing quality have been considered and implemented in different health care systems and organizations with diferent outcome and not much of formal scientific research. Nevertheless a twenty years experience with Total Quality Management in health care in Spain , has allowed the authors to draw a stepwise integration of various industrial approaches, like ISO 9000 and Excellence Models, with specific healthcare ones, like the Canadian Council on Health Facilities Accreditation, the Australian Council on Healthcare Standards and the Joint Commission on Accreditation of Healthcare Organizations, in order to focus on the safety of the patient as the core consideration. In this article the Total Quality Programme in the Spanish Health Care System (1986-1992) and the subsequent quality improvement steps that have led to definition and implementation of such an integrated framework seeking a quality management system and patient safety , are discussed. Key words: quality management systems, patient safety , integrated quality management. International Journal of Health Care Quality Assurance Volume 17 – Number 6 – 2004 . pp.323-333

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QUALITY MANAGEMENT IN HEALTH CARE. A TWENTY YEARS JOURNEY.

“A long journey always begin with a single step” Lao-tzu , (China, 604 BC-531 BC)

The issue of quality in healthcare.

Healthcare providers, that is professionals, financiers and politicians are confronted with one of the most perplexing issues in today´s healthcare: the debate on how to improve the quality of care delivered to the community without loosing historically adquired roles and responsibilities(BMA, 1988; Coile, 1990; Arndt, 1995; Bigelow, 1995; Blumenthal, 1996;)

Although many approaches to improve quality in health care organizations have been implemented along the past century, little systematic research assessing their effectiveness has been reported (JCAHO, 1988; Harrigan, 1992; Ovretveit, 2003)

In the past two decades the acknowledgement of either medical errors or system errors in healthcare organizations, leading to patient injury and even death, has generated an increasing body of knowledge found in the literature as well as potential healthcare legislation, media exposure and consumer awareness.(Leape, 1991 & 1994; Liang, 1999; IoM, 1999 & 2001; Becher, 2001). Patient safety, defined either as freedom from accidental injury due to medical care, or absence of medical errors or absence of misuse of services has become a major issue for healthcare quality. A number of questions remain unanswered worldwide:

• who is the ultimate responsable for the care of people?

• which one is the best health care system approach?

• how to assure the quality and safety of care?

• which is the information needed in healthcare systems for its improvement?

• what are the expectations and demands of healthcare professionals?

• what are the expectations and the demands of the community?

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Traditionally the technical knowledge of medical and nursing professionals has been considered sufficient for asssuring quality and safety for the healthcare provided to the citizen..

However today´s healthcare centres are complex organisations where appropiate medical care requires administrative and managerial support to get the patient safely discharged. Organisational change has to emphasize the links between quality systems and working practices, as well as appropiate and safe care.

Developping and implementing such an approach in healthcare institutions and systems requires fundamental changes in the organization´s culture, structure and working methods.

Health system reforms in most industrialized countries are increasingly asking for active involvement of physicians and other healthcare professionals together with an increasing recognition that health care providers have to respond to the preferences and values of the patients as their customers ( Thompson, 1999). Furthermore, interested parties such as service providers, service payers, customers and politicians are demanding reliable ways for assessing the services provided. Thus the attemps to increase the efficency and effectivenes of health care systems have to deal with the equity issue (Relman, 1988) rather than with the competition one (Thompson 1998).

The establishment of normalized criteria and standards for appropiate and safe health care provision as well as mechanisms for evaluating the systems and organisation´s performance, country and worldwide, is still a crucial issue in need of a valid and recognized answer (Scrivens 1995; Shaw, 2000; Schyve, 2000;).

Even though a common approach to accreditation is urgently needed there are some key differences that prevent the direct application of the traditional accreditation approaches in countries like Spain where healthcare has been, up to recently, mostly a public sector service ( Simon. 1995) .

A tradeoff of the classical technical quality assurance and professional power well known by healthcare-providers and the most recent approach of continuous improvement of organisations, as developed in the industrial and services sectors, can be achieved through an integrated approach. Such an approach should allow measuring, assessing and comparing organizations´ performance through a combination of internationally accepted certification standards, accreditation schemes and excellence models criteria.

The need for an organisational change in the healthcare system

Healthcare institutions are typical professional organisations where a specific profession establishes its rules for managing the whole of the organisation and does not accept willingly changes that might limit his power.

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To move from the old organizational structures of health care institutions to a new organisational and managerial design, deliberate transitional steps are neccessary.

It is important to emphasize that, at least in Spain, healthcare institutions do not have the required managerial maturity for seeking organizational excellence at once. Quality systems have to be established first as an initial step for buiding the process foundations needed in a modern organization. Self-assessment and continuous quality improvement as managing paradigm towards organisational excellence have to be pursued in a step-wise fashion in order to have reasonable probability for success.

If carefully designed and well-placed, these transitional measures will permit policy to evolve along consensual lines and can signal the overall direction of change reassuring stakeholders that change is taking place smoothly and that the most inmediate problems are being dealt with. It also helps to ensure that longer term systematic objectives are not compromised by short term political imperatives.

This is a long term venture which, in the Spanish case, was started in 1986 with a Total Quality Program for the Spanish Health Care System ( Ruiz, 1992) and is being pursued as an integrated approach for certification, accreditation and continuous improvement of the healhcare organizations focused on patient safety.(Ruiz, 1999).

The Spanish health care system

Currently the healthcare system in Spain is a mixed public-private system where the public sector is responsible for about 80 % of the total cost which represents 6.5% of the GNP.

The Spanish Constitution of 1979 recognizes the right of all citizens to health care coverage and health protection, and places upon the State the responsibility for transfering health care services management to the 17 Autonomous Communities and for coordinating the establishment of general health care policies through a National Health Council.

In 1986 the General Health Law passed and created a National Health System publicly funded, in large part from the state budget, and establishing a quality control and assessment framework for all health care organizations within the system. By the end of 1987, 97.1 % of the Spanish population was covered for healthcare through the public healthcare system which was financially managed and operated by the National Institute of Health, INSALUD as the Government agency for the management of the Spanish health care system..

This law provided the basic foundations for the subsequent development of all the elements needed to set up a system which would assure the quality of the health services.

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Therefore, according to the Constitution and the General Health Law the budget and managing responsibility for the regional Health Care Services has been progressively transferred from the INSALUD to the existing 17 Autonomous Regions. The Ministry of Health coordinates all health care services through the National Health Council.

In May 2003 a new bill on “Cohesion and Quality in the National Healthcare System” was passed in Spain. In this bill a whole chapter deals with quality issues in healthcare, establishing that quality improvement should be the focus for any initiative in public and private health care organizations.

Nevertheless the development of quality control and assessment mechanisms as established by law has faced major obstacles since the change to a new system has greatly suffered from existing shortcomings.

Firstly overcoming the historical absence of adequate budgeting and accounting mechanisms is proving difficult. Secondly the different political environment in the respective regions has made transferring managing responsability a complex process with respect to the amount of expenditure to be transferred, the timing and procedures for transfer, and mechanisms for compensation. Thirdly accountability is still deficient due to chronic sliding of deficits; problems with personnel and rigid operational procedures still persist.

Despite these difficulties significant achievements in the management of the regional and central health care services in Spain aimed at increasing consumer choice, purchasers of services information, expenditure control and creating incentives for performance, should be mentioned.

Among those achievements the development of the Spanish Healthcare System Total Quality Plan from 1986 through 1992 allowed the implementation of a normalised patient data base system, a normalised cost-activity/accountability information system and the pursuit of accepted self-assessment certification and accreditation schemes.

The first step : The Spanish Total Quality Management Plan

In 1986, according to the General Health Law passed that year, a programme according to the Total Quality Management Plan, Phase I (Ruiz, 1988) was launched by the newly established Total Quality Unit under the General Directorate of the INSALUD, within the Spanish Ministry of Health and Consumer Affairs. The Plan was published as a benchmark by the Regional Office of WHO-Europe in 1990 (WHO-E, 1990).

The aim and objectives of the Plan were established considering the deficencies in the Spanish health care system, and resulted in the action lines and the operative framework of the Total Quality Management programme which are discussed in a previous publication (Ruiz, 1992).

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According to these action lines an operative framework of four cascading projects was designed and carried out step-wise between 1986 and 1992 as Phase One.

Actions and landmark-events were focused on defining a common data base, an information system and a culture change for establishing quality mmanagement systems as well as certification/accreditation schemes in the health care system.

Phase One encompassed four cascading projects that were managed as Demonstration Projects

The implementation was carried out in 5-6 hospitals at a time through, pilot studies and working groups establishing a network of interelated activities and cascading outputs.

The hospital participation in the programme was established on voluntary basis but requiring the formal committement of the hospital managing body.

Education and training were fulfilled as basic horizontal activity within all the projects.

(A) NUBIS Project: Definition and establishment of a minimum basic data set. (Demonstration Project in 5 hospitals)

(B) CODIGO Project: Codification and implementation of the basic data set. (Demonstration project in 6 hospitals)

(C) SICE Project: Definition and establishment of a grouper system relating clinical data, resources used and cost. Definition and implementation of an analytical accounting approach. (Demonstration project in 5 hospitals).

(D) GACSA Project: Introduction of a standard framework for implementing quality improvement in 62 hospitals of the Spanish health care system applying quality management methodology and training as well as definition of process outcome indicators.( Simon, 1995)

Outcomes for the six year program.

As established in the Plan, outcomes of Phase One from 1986 to 1992 focus on the establishment of an information system, both, clinically and result/cost oriented which will allow the organizational assessment as well as improvement and benchmarking through quality improvement culture in the Spanish healthcare organizations (Ruiz, 1994).

Outcomes are considered relevant if they have been instrumental for subsequent operations for improvement of the health care system or have been formally established as requirement in the Spanish health care system.

We consider as most relevant outcomes the following:

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Minimum Basic Data Set (NUBIS and CODIGO projects) • A Minimum Basic Data Set (Conjunto Minimo Basico de Datos,CMBD

in Spanish) of 14 items was defined according to the one proposed by the European Council in 1982 and the one established in the USA as UHDDS.

• The Clinical Modification (USA) of the 9th International Classification of Diseases (WHO) known as ICD-9-CM, was translated into Spanish and adapted to the Spanish medical practice by the National Medical Specialties Board in order to codify diagnosis and procedures in the CMBD.

• The National Health Council approved the two proposals as the potential Data Bank for the Spanish Healthcare Information System in December 1987.

• In 1990 the Ministry of Health published the first spanish version of the ICD-9-CM (ICD-9-CM 1987) as well as an User´s Manual (Unidad de Garantia de Calidad Total, 1990) .

• In February 1992 the Ministry of Health established the CMBD as a formal requirement for the Spanish Healthcare System.

• A formal working position, for ICD-9-CM codifiers in hospitals was established in all Healthcare System organizations.

Patient grouping system (SICE project)

Evaluation of the two main groupers at that time(PMC and DRG) was carried out and the results discussed at a national meeting in 1991.

The Ministry of Health establishes the Spanish adapted version of the Diagnosis Related Groups (DRGs) as the case-mix measuring system relating clinical data and cost for the Spanish healthcare system (1992).

An analytical accounting system according to the DRG´s grouper , the SIGNO Program was devised. This approach and a companion manual were published by the Ministry of Health to be used for accounting in the health care organizations of the Spanish healthare system.( Ruiz, 1990; Ruiz, 1991).

A Central Health Care Information System Unit was established at the Ministry of health and Consumer´s Affairs, where data of 98% of all the admitted patients to spanish hospitals is stored, processed, and published (1993). The governance of the Unit is carried out by a Central Technical Committee where all the Autonmous Healthcare Services are represented.

Quality improvement methodology (GACSA project)

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Partnership of 62 hospitals of the Spanish National Health Care System in a European Concerted Action research project (COMAC) on the advantages of quality assurance in health care (Klazinga, 1994; Simon, 1995)

Training in quality improvement methodology and tools for the 62 hospitals participating in the COMAC project.

Quality in health care is established as a separate body of knowledge in the revised medical school curricula (National Committe for establishing reformed curricula in university titles at the University Council, 1988).

Quality assessment (GACSA project) • Initial standards and indicators were established in order to assess the

quality in healthcare organizations as an input for Phase II of the Total Quality Management Plan.

The Ministry of Health publishes a “Proposal of Guidelines for Accrediting Hospitals in Spain”, (Ruiz, 1991), and a software programme (EPIHOS) for recording and analysing hospital infection (Ruiz, 33)

Three longitudinal surveys were carried out amongst the consumers of the Spanish healhcare system in 1985, 1988 and 1990 and the results analysed as input for indicators definition.

Lessons learned It is well accepted in the literature that barriers and obstacles for implementing quality systems in health care organizations reflect traditional existing culture as well as structural and functional deficencies.( Dale, 1990; Atkinson, 1990 )

The following factors seem to have been key to the succes versus failure of specific actions carried out along the implementation of the Total Quality Plan in different hospitals of the Spanish Health Care system.

• professionals´ willingness for establishing a valid information system,

Poor motivation is the result of an endemic absence of significant feed- back information.The data generators, particularly physicians, should be convinced that the effort involved in collecting reliable data was worthwhile both for themselves and for the organization as a whole.

• commitment of the top management and clinical staff;

The prevailing climate of mistrust between managers and health care professionals, mainly physicians, made common objectives difficult to set and has been a primary obstacle to overcome. Formal committement has been required from both of them as a trade off for satisfaying existing expectations and demands.

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• establishment of a quality improvement methodology based on uniform concepts and criteria

The so-called quality philosophies (i.e. control vs assurance, assurance vs immprovement, reengineering vs continuous improvement, medical quality vs organizational quality, amongst others) have been used not unfrequently for landmarking parroquial interests.

A normalized methodology should seek that the problems identified, the solutions proposed and the results obtained could be compared, both within and between different institutions and countries.

The health professionals themselves should be actively involved in the development of process approach, quality system criteria and outcome indicators.

The health care system and health care organizations should establish a sound customer-provider relationship within it.

The management and outcomes of the Total Quality Program allowed the authors to draw unique lessons and definite operative conclusions which masterminded later developments and present initiatives such as the integrated approach towards excellence.

AN INTEGRATED APPROACH TOWARDS EXCELLENCE

Steps towards Excellence.

In 1994 the University Institute for Healthcare Assessment (IUES) was founded in order to pursue the operative conclusions gathered by the authors from their direct involvement with the Spanish Healthcare System Total Quality Plan previously described.

Today there is a clear convergence of traditional external quality evaluation approaches like the Joint Commission on Accreditation of Healthcare Organizations approach and managerial approaches for assessing performance like the Excellence Models and ISO 9000 (Schyve June 2000 & 2000) The normalization of external evaluation in between countries and within a country is becoming a requirement for improving healthcare systems in developed countries.

Applying recent theories on organisational change and learning organisation the IUES initiated the development of a stepwise methodology for self-assessment of health care organizations searching for quality improvement, organisational excellence and patient safety according with two basic considerations:

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• On one hand we should accept the fact that voluntary certification and accreditation represent, at present, a neccessary recognition by service payers of the safety and suitability of health care organisations as providers.

• On the other hand self-assessment against an Excellence Model may be seen as a higher development stage which is able to drive the organisation beyond the scheme of external evaluation and to establish a method for managing the collected knowledge gathered from the self-assessment exercise. Not to forget newer approaches like Balanced Scorecard and Six Sigma adding strategic and tactic dimensions to the Excellence Models.

Consequently a two level approach was developed. This approach was implemented as a three years demonstration project in a 400 bed public sector hospital. The outcome of the first two years experience has been published (Ruiz, 1999).

This two levels approach establishes criteria and standards to be used for self-assessment and improvement according to the degree of organisational maturity:

• level 1 for implementing quality management systems (ISO 9000:2000 and ISO 14000:1996) and specific quality assurance in health care organizations (JCAHO/CCHA)

• level 2 for progressing towards a model of excellence (EFQM).

Both levels apply the PDCA cycle as methodology for continuous improvement.

Such a stepwise approach to certification/accreditation and self-assessment facilitates initiation on the road of continuous learning and improvement and allows for a progressive implementation of knowledge management towards excellence in modern health care organisations and systems.

Furthermore it allows healthcare organizations and systems to apply true managing approaches, tools and methodologies, which have been useful in the industry and services sectors, and have also proved their promise when applied to the healthcare sector. We consider mainly:

• ISO International Standard for Quality Management (ISO 9000:2000) • ISO Environmental management systems. Specification with guidance .

for use (ISO 14001:1996). • Baldrige National Quality Program:Criteria for Performance Excellence. • Excelence Model, European Foundation for Quality Management . • Balanced Scorecard. • Six Sigma

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We will briefly comment on the application of these approaches to the healthcare sector:

ISO 9000:2000 Standards

The ISO 9000:2000 standard is being increasingly considered for implementation in the healthcare sector (Sweeney, 2000; Staines, 2000). The standard specifies how to implement a quality management system which means a quality assurance system which prevents errors and therefore assures patient safety as a foundation for any other quality improvement approach in healthcare. “This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness and efficiency of a quality management system to enhance interested party satisfaction by meeting interested party requirements” (see ISO 9001:2000). “ The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “process approach” (see ISO 9000:2000 ) At present two main initiatives for implementing ISO 9001:2000 and ISO 9004:2000 in healthcare services are being developed. One by the International Standards Organization (ISO) itself and the other one by the European Committee for Normalization (CEN). In September 2001, ISO published its first International Workshop Agreement (IWA 1) as an ISO 9004:2000, Guidelines for process improvement in Health Service organizations to be used for defining the fundamentals of the healthcare organization´s quality management system and continuous improvement methodology, but not as substitute for traditional accreditation. “The goal of this document is to aid in the development or improvement of a fundamental quality management system for health service organizations..that provides for continuous improvement, emphasizing error prevention, the reduction of variation and organizationbal waste..” (see ISO 9004:2000)

In May 2002 CEN launched a Task Force, CEN/BT TF 142, in order to develop a technical specification and a technical report for the implementation of ISO 9001:2000 and ISO 9004:2000, in the European healthcare sector. The technical specification will be a guide to the use of ISO 9001:2000 for healthcare services to improve quality management of clinical and non-clinical (support) services.The specification will be useful for healthcare organizations that are working with quality improvement but it will be also possible to use the specification as a basis for certification.

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The technical report will be a guide to the use of 9004:2000. It is expected that the documents will be ready by 2005 and 2006.The secretariat of the CEN Project is at the Swedish Standards Institute.(www.sis.es).

ISO 14001:1996. This environmental standard is increasingly applied together with ISO 9000:2000 in order to establish an integrated management system. Environmental issues are very important in healthcare services and can be managed through this standard.

Baldrige National Quality Program:Criteria for Performance Excellence.

While healthcare organizations have traditionally integrated concepts of quality into its management, more and more they are being held accountable for demonstrating evidence to support this direction. Utilizing the Baldrige Criteria for Performance Excellence can help healthcare organizations more fully integrate the concepts of quality throughout the total organization. The major practical benefit of using a common framework for all sectors of the economy is that it fosters cross-sector cooperation and sharing of best practices information. The framework of the Baldrige Business Criteria for Performance Excellence is adaptable to the requiremenmts of all organizations including healthcare organizations. However it is not assumed that these requirements are necessarily addressed in the same way. Therefore a specific way for addressing the Baldrige Criteria has been developed as Health Care Criteria for Performance Excellence. This adaptation to healthcare is largely a translation of the language and basic concepts of business excellence to similarly important concepts in healthcare excellence . The Baldrige Model in Health Care has been used in several healthcare organizations in the USA and its implications have been discussed along the past decade. (Hertz, 1994; Gaucher, 1995; Jensen, 1996; Weeks, 2000; Goldstein, 2002) For the first time, in 2003, the Malcom Baldrige National Quality Award was given to a health sector organization, the SSMHC in St Louis, MO, USA www.ssmhc.com.

Excellence Model, European Foundation for Quality Management .

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The above considerations can be applied to the European Excellence Model. The EFQM Model is a non prescriptive framework that recognises there are many approaches to achieving sustainable excellence. It has its roots in the philosophy of the Total Quality Management. This framework is structured on the following Fundamental Concepts:

• Results Orientation • Customer Focus • Leadership & Constancy of Purpose • Management by Processes & Facts • People Development & Involvement • Continuous Learning, Innovation & Improvement • Partnership development • Public responsabilityy

The premise on which the Model is built is that Excellent results with respect to performance, Customers, People and Society are achieved through Leadership driving Policy and Strategy, People, Partnership and Resources, and Processes. The Model was initially used as a self-assessment tool.The organization´s self-assessment allowed to get the picture of that “moment in time” where the organization stood. The Excellence Model is being also used as a measurement tool. Organizations are realizing that for the outcomes of the Self-Assessment process to have maximum value, it needed to be linked with other business planning process. The EFQM Excellence model is a practical tool to help organizations establish an appropriate management system and measure where they are in their path towards Excellence; helping them to understand the gaps; and then stimulating solutions. (www.efqm.org.) In 1996 EFQM developed a specific Guide for using the European Excellence Model in Health Care but in 1999 the model was revised and a common framework is being applied to all sectors, industry as well as private and public service sectors, including healthcare. The European excellence model is being applied in healthcare organizations of several European countries.(Arcelay, 1999; Breinlinger, 2000; Nabitz, 2000; Jackson, 2001).

Balanced Scorecard. The Balanced Scorecard is a framework that helps organizations translate strategy into operational objectives that drive both behaviour and

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performance. It describes and helps implement and manage strategy at all levels of an organization by linking objectives, initiatives, and measures to that organization´s strategy. It is, as well, a process that the organization uses to foster consensus, alignment and commitment to the strategy by the management team and the people within the organization at large. It provides an enterprise view of a healthcare organization´s overall performance by integrating financial measures with other key performance indicators around customer (patient, physician, payer) preferences, internal clinical and business processes, and personal learning, development and growth ( Pink, 2001; Radnor, 2003; Zelman, 2003) The first Best Practices Conference focused on how health care organizations use the Balanced Scorecard to achieve results was organized by the Balanced Scorecard Collaborative ( www.bscol.com) in Cambridge, Mass., USA, in April 2002. There, North American healthcare organizations like Duke Children´s Hospital, Blue Cross/Blue Shield of Minesota, Montefiore Hospital Center, Alterra Health Care, St Mary´s/Duluth Clinic, offered their experience having used the Balanced Scorecard as a powerful performance framework.

Six Sigma Six Sigma is a quality initiave based on rigorous statistical process control. It augments traditional quality tools with exacting statistical analysis and a systematic problem–solving approach, targeting the root-cause of variations and redefining processes for long term improved results. It pursues to produce products and services with only 3.4 defects per million, meaning six sigma in statistical terms. Six Sigma can be, thus, considered a business quality improvement tool. It requires four steps, where data collection and analysis become the core of the Six Sigma Projects:

• Measure • Analyze • Improve • Control

Six Sigma is also a business culture approach, since the goal is to establish a culture of quality improvement at all levels of the organization by implementing improvement actions designed by specifically trained working teams. In the healthcare sector, Six Sigma, as a philosophy seeking near zero errors, and being, somehow, an extension of Failure Mode and Effect Analysis is

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ripe for its implementation by healthcare managers and practitioners concerned for patient safety and are already implementing a Total Quality Management approach ( Revere, 2003; Ettinger, 2003)

An integrated approach: ISO 9000:2000, traditional Accreditation, Excellence Model, Balanced Scorecard and Six Sigma

It seems therefore that healthcare organizations can benefit from learning from other sectors that have implemented quality assurance and quality control on a continouous improvement culture. Furthermore patient safety has become a priority issue after the IoM report and it appears that sectors like the aviation one can be a good benchmark for safety within the healthcare sector. ( Helmreich, 2000). A practical approach to improving patient safety would be the integration of approaches from other sectors that have proved to be useful in healthcare ( Ruiz, 2004). The traditional approach to external evaluation of healthcare organizations was a breakthrough when the American College of Surgeons established the Hospital Standardization Program in 1917. In 1950 the growing number and complexity of hospitals required revision of the standards and support of the entire medical and hospital field originating the Joint Commission on Accreditation of Hospitals (JCAH) in 1951 (Roberts, 1987). But the performance of the health care organizations in the USA was challenged by the 1999 report of the Institute of Medicine of USA indicating that medical errors kill more than 44,000 people in the US hospitals each year, more than from motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516) and total national costs of preventable adverse events are estimated between $ 17 billion and $ 29 billion. There are no similar studies for any other country but the World Health Report 2000 of WHO states that “...many countries are falling short of their potential. There are serious shortcomings in the performance of one or more functions” according to ( see WHO 2000)

Therefore it seems that finding the appropriate management systems for health care organizations in technically developed countries, is becoming a high priority. It seems due to find an acceptable methodology for measuring, assessing and comparing organizational performance through valid standards as well as recognizing self-assessment and accreditation results as valid measues of performance and efficency.

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Integration of diverse approaches and methodologies by sequential steps appears to be the best way to achieve implementation of quality management systems and the appropriate culture to assure patient safety and organizational excellence.

Initial step

Early implementation of process thinking is a basic stepstone, better if it is the initial one, in the continuous quality improvement journey towards excellence. We understand “process thinking” as meaning that in order to function effectively and efficiently an organization has to identify and manage all its linked activities, or processes, since the output of one is generally the input of another one. The system of processes within the organization has to be defined and managed. The new ISO 9000:2000 promotes the adoption of a process approach and therefore, at present, ISO 9000:2000 is the best tool for implementing “process thinking “ and quality management systems in an organization. Understanding, systematizing and controlling processes is the best way available today for preventing processes and system failures as well as human errors. It is the most reliable approach for increasing patient safety.

Second step Once the quality management system is in place, the health care specific standards like the ones offered in the traditional healthcare accreditation approaches, should be implemented.

Third step When the organization is working effectively, efficiently and safely an Excellence Model can be established as reference for the organization´s pursuit of excellence. Initialy using the EFQM Model for self-assessment an organization will have a good understanding of its own strengths and weaknesses at the process level. Scoring according to the Model will offer a reference point for internal compairisons along periodical self-assessments and improvement actions and also for external benchmarking. However, it may not have a strong sense of where to invest as a strategic priority, or where improvement will make the biggest impact in business performance and results.The Balanced Scorecard can be used at this point to provide the strategic focus needed to prioritise action and allocate resources.

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The Six Sigma approach prioritise resource allocation, facilitate internal comparisons and allows external comparisons for benchmarking. It can be easily integrated into existing quality management efforts through detailed data analysis, becoming part of the strategic plan. Benefits such as reduction in costs of poor quality and improved profitability will be obtained.

Conclusions

Interest for quality in patient management has been formally present amongst the healthcare professionals since the American College of Surgeons established its standard in 1917. The importance of health care standardization was recognized by the founding of the Joint Commission on Accreditation of Hospitals in 1951 in the USA. Today after the Institute of Medicine report in 1999 patient safety is on the limelight of health providers, payers politicians and consumers.

The patient management approach has to be revised and the healthcare management system should be overhauled in order to discover the system failures that allow for the findings that have been insistently denunciated in the medical literature for the past decade and finally reported by the Institute of Medicine. The authors´ twenty years journey in total quality management has allow them to draw some tentative hypothesis to work with in search of a safer and more efficient heath care system.

Piece-meal application of quality control methods, quality assurance schemes, quality management philosophies and their assessment through diverse external evaluation approaches have proved their insufficiency for dealing successfully with quality management systems and with patient safety.

Integration of the diverse methods, schemes, philosophies and approaches for establishing a culture of self-assessment and continuous quality improvement in a journey towards excellence, seems to be an alternative worth to be explored.

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