Healthcare is widely regarded as a human right. Article 3 of the Convention on Human Rights and Biomedicine requires contracting parties to provide “equitable access to health care of appropriate quality,” and Article 11 of the European Social Charter implies that health care of good quality is a fundamental right of every Individual and every community. Thus, quality improvement at the population level implies striving for accessibility to services, equality between and within communities, and overall system effectiveness and efficiency of utilization.

Patient safety concerns and quality measurement requirements have given rise to the notion of accreditation. Accreditation is an internationally recognized evaluation process used to assess and improve the quality, efficiency, and effectiveness of health care organizations. Simply put, accreditation is based on the premise that adherence to evidence-based standards will produce higher quality health care services in an increasingly safe environment. It is also a way publicly to recognize that a health care organization has met international quality standards. The rapid growth of accreditation over the last 30 years is partially attributable to media reporting of serious inadequacies in the quality and safety of health care services, as well as an escalating focus on patient safety.

Most accrediting bodies’ health care accreditation programs consist of periodic or cyclical assessments of organizational and clinical practices and the measurement of their performance against pre-established, evidence-based standards. This is usually done through self-assessments, peer surveyor on-site visits, interviews by the surveyors, and the careful study of administrative and clinical data and documentation.

The French National Authority for Health (HAS), the German « Kooperation für Transparenz und Qualität im Gesundheitwesen (KTQ) », the Italian Health Regional Agencies, the Spanish regional accreditation associations, and the Joint Commission International (JCI) are the organizations that deliver accreditations to hospitals in France, Germany, Spain, and Italy. The various steps for obtaining accreditation or certification may differ slightly from country to country, but the overall process is very similar to that existing in the United States.

All INDIGOMED providers must possess at least one accreditation and certification from one of these agencies.

Accreditation methodologies convergence

There are three main international healthcare accreditation and certification standards, which are used worldwide:

  • The EFQM Model (EFQM)

    The European Foundation for Quality Management (EFQM) is a membership-based, not-for-profit organization created in 1988 by 14 leading European businesses. Its mission is to be the driving force for sustainable excellence in Europe. In addition to being the owner of the EFQM excellence model and managing the European Quality Award process, it also provides a portfolio of services for its members.

    Excellence is defined as outstanding practice in managing the organization and achieving results, based on nine fundamental concepts: results orientation, customer focus, leadership and constancy of purpose, management by processes and facts, people development and involvement, continuous learning, improvement and innovation, partnership development, and public responsibility.

    Excellence is not just a theory. It is the achievement of a tangible level of results, and the evidence that these results can be sustained. As well as financial results, the model uses a variety of indicators including measured excellence in customer satisfaction and loyalty, people motivation and capability, and the satisfaction of the wider community.

  • The ISO Model (ISO)

    ISO 9000 is a generic system that specifies, in very broad terms, the necessary components of a quality management system. Rather than being specific to any industry, it details the basic requirements of the quality function for all industries. ISO 9000 was originally published in 1987 by the International Organization for Standardization, a worldwide federation of standards bodies headquartered in Geneva. The organization was founded in 1946 to develop a common set of standards for manufacturing, trade, and communications, and today has more than 90 national members.

  • The Joint Commission Model (JC)

    The Joint Commission evaluates and accredits nearly 19,000 health care organizations and programs in the United States. An independent, not-for-profit organization, the Joint Commission in the US is the nation’s predominant standards-setting and accreditation body in health care. Since 1951, the Joint Commission has developed state-of-the-art, professionally based standards and evaluated the compliance of health care organizations against these benchmarks.

    The mission of the Joint Commission on Accreditation of health care organizations is to continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations.

    The Joint Commission evaluation and accreditation services are provided for the following types of organizations: general, psychiatric, children´s, and rehabilitation hospitals; health care networks; home health care organizations; nursing homes; assisted living residences; behavioral health care organizations; ambulatory care providers; and clinical laboratories.

  • Comparing the models

    Funded by the EU, the ExPeRT (External Peer Review Techniques) project (Shaw & Heaton, 2000) was designed to investigate the scope, mechanisms, and use of external quality systems in the improvement of health care in Europe and other countries.

    Methods of developing and accessing organizational standards range from the medical specialty-driven “visitation/visitatie” (The Netherlands and the UK), to traditional accreditation (developed in North America, Australia, the UK, Spain, The Netherlands, Finland, Italy, France, Sweden, Germany, and Switzerland) and European Quality Awards (Scandinavian nations, The Netherlands, and Spain), to industrial certification using ISO standards (Germany, the UK, Switzerland, and Spain). The project was devoted to analyzing their differences and similarities:

    The “visitatie” method is driven by professional organizations and has a long tradition in health care as a form of peer review. The basis of assessment is primarily clinical and confidential and less explicit than the standards and processes of ISO or EFQM.

    The Accreditation Model (Joint Commission) is based on an assessment by a multi-disciplinary team of health professionals against published standards. Facilities complying with these standards are awarded certificates of accreditation.

    The EFQM (European Foundation for Quality Management) model was inspired by the Baldrige Awards (developed in the US for improvement of quality in production industries). Health care providers seeking a European Quality Award are assessed against performance standards for service industries in specific areas such as clinical results, patient satisfaction, administration, and staff management. It was revised in 1999.

    ISO 9000 (International Standards Organization) has been used mostly in mechanical settings (laboratories, radiology, and transport) but has also been applied to whole hospitals and clinics.

    According to Shaw and Heaton, the four models have begun to converge spontaneously. They believe that clearer demarcation of scope and the contribution of each model could increase efficiency and reduce duplication in the external quality improvement market. This would require a range of compromises including Policy (priorities, explicit values, continuous improvement, conceptual framework, customer response, transparency, and legislation), Organization (national co-ordination, European communication, and international liaison), Methods (language, standards, cross-walking, assessment, quantification, and clinical performance and assessment skills), Resources, and Evaluation and Quality (program performance, independent verification, and research).

  • Convergence and integration of the models

    Donahue and Van Ostenberg (2000) described the components of the new Joint Commission International (JCI) accreditation program for hospitals and compared it with the four quality evaluation models described under the ExPeRT project (« visitatie », ISO, EFQM, and organizational accreditation).

    All the models have, in common with the JCI program, the use of explicit criteria or standards and the use of external reviewers. The JCI program is an organizational accreditation approach with evaluation of all the “systems” of a health care organization. The JCI model evaluates the ability of an organization to assess and monitor its professional staff through internal mechanisms, in contrast to the external peer assessment used by the “visitatie” 2376 model. The JCI program provides a comprehensive framework for quality management in an organization, expanding the boundaries of the quality leadership and management found in the EFQM model and beyond the quality control of the ISO model. The JCI organizational accreditation program was designed to permit international comparisons, which are difficult to accomplish under the other models due to country-specific variations. Donahue and Van Ostenberg concluded that the JCI program provides a framework for the convergence and integration of the strengths of all the models into a common health care quality evaluation model.