Description of work

1. Context and definition of external auditing

1.1 Context: A growing need for mandatory auditing systems

There is a growing public demand on European countries' governments for a better medical service. This demand combines with a global demand for additional transparency and pay-for-performance medical systems. Many studies also point to the public dependency on the closest neighbouring medical establishment. The public has often few or no opportunity to select the best establishment, and the demand is clearly to have a standardised level of good and safe care in each establishment wherever it is located 1 . This standard of safe care is expected to cross borders as the mobility of patients increases. Politicians may well loose elections if this national standard of care is not attained. The consequence is clearly a move towards more tandardised and mandatory auditing processes, to the detriment of optional and voluntary programs.

Another consequence is that such a progressive shift towards mandatory systems and greater accountability, if generalized, could result in an alignment of external auditing to minimum standards. In this context, one of the challenges is to structure external evaluation models that will foster improvement as well as accountability and will mobilise all organisations whatever their level of quality towards objectives of excellence.

The growing need for European harmonization, which is the very reason of the SIMPATIE project, is particularly sensitive to this aspect, and will probably accelerate the move to a minimum mandatory common platform for auditing; conversely, the development of new advanced and costly patient safety initiatives could be considered in the next decade of much lower priority compared to this need of a common basic platform within and among EC countries.

1.2 Definition of external auditing

• covers all auditing actions related to delivery of care;


• is carried out by staff who do not belong to the health care organisation being audited (although the process is necessarily connected to internal evaluation, both processes ideally converge on a similar set of safety goals and indicators and feed one another);


• strives to provide an objective assessment of the quality of services delivered by the HCO against the most up to date standards;


• identifies weak points to be improved by a specific deadline;


• contributes to transparency and quality in the health care system through information and external recognition; and, by this


• ensures user confidence in the health system and in the care delivered.


Beyond local improvement, it is expected that the external auditing process will induce system-wide changes involving multiple HCOs, and on a national scale in case of national programs 2 .

1.3 The three key steps of external auditing

A comprehensive approach of external auditing is based on a thorough description of three milestones:

• The first point is to make the objectives of the auditing process as pertinent and as clear as possible.


• The second point concerns methods to evaluate the achievement of objectives. The port-folio of methods should be described at various levels of granularity from general principles to detailed tools.


• The third point focuses on how to deal with the results and how to make decisions, and on the follow-up by corrective and maintenance actions.


These three points organize the sections of this report.

2. Objectives for external auditing and progressive changes in focus

2.1 The four families of objectives for external auditing

Four aims are usually identified to achieve this overall objective of auditing quality and safety of care. These four aims are not necessarily covered in the same level of detail by all external audits. The first objective is to assess the means, programs and actions implemented in the promotion of patient safety. The second is to assess the organisation actual performance in terms of patient safety. A third objective is to have an assessment process that is cost effective. Lastly, the model should promote coordination of internal and external evaluation activities in order to diminish redundancy and increase efficiency.

2.1.1. Assessment of the resources available and the proper use of a toolkit of good safety practices:

* This refers to the actual use of the tools rather than to the results obtained from them (next point in this paragraph). The following factors are worth mentioning (list not exhaustive):

a) Tools related to specific risks that monitor the implementation of:


• at-risk subsystems in the HCO's hotel systems infrastructure : building protection systems (fire, flooding, etc.), quality monitoring systems for perishable or hazardous products and foodstuffs (food and health products, water, medicines)


• at-risk subsystems in the HCO's clinical infrastructure: calibration of measuring instruments, systems to monitor medical devices and healthcare products, such as medicines, waste products, care environment and water, to assess patient records (traceability of prescriptions and of communication between health professionals, etc.) information systems, emergency plans to deal with exceptional risks, and patient rights


• clear medical and treatment standards for clinical risk management in the HCO (for example, the prevention of care-related risks such as risks of thromboembolism, poor pain control, loss of autonomy in geriatrics by the application of management protocols)


b) Elements related to risk management initiatives:


• Incident reporting systems for all forms of incidents, with a range of associated tools for managing and learning from these situations (and the proper use of these tools) (vigilance systems, voluntary reporting systems at departmental or HCO level, patient satisfaction questionnaires, systems for taking account of patients' views, failure mode, root cause analyses or other forms of risk analysis, walkrounds, computerised monitoring systems, data recovery based on SSPI data, etc.)


• Risk management structure, organisation chart or definition of responsabilities within the hospital, possibly with a senior member of staff allocated to it


• Active policies for disseminating a culture of safety within the HCO : dissemination of information, feedback on morbidity and mortality to professionals and other staff, involvement of top management, different campaigns, patient information and education, etc.


• Use of the tools listed above is of course also assessed in terms of the HCO's human resources policy, dedicated job functions or time made available for these types of action, associated financial support, and further training in relation to these objectives.

2 1.2. Assessment of the HCO's own performance in safety of care

* This involves assessing an HCO's performance in the field of patient safety in an external monitoring program

* This quantitative assessment is based on the regular monitoring of safety initiatives (declaration of adverse events, declaration in the different vigilance systems, number of complaints) and the use of rate-based risk indicators (analysis of satisfaction questionnaires, clinical or organisational audits) This will involve eventually measuring the appropriate use of a policy or program and the measurement of context of care often termed safety culture. The evaluation of institutional resilience (see e.g. Carthey, de Leval, Reason, 2001) by means of questionnaire and indicators may permit going beyond the classic focus on the medical staff, focusing on the high level management strategies to concretely arbitrate the politics in favour to safety 3

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2.1.3. Assessment of the best cost-efficacy ratio for the initiative

There are two aspects to this:


• (i) the cost-efficacy of the action itself in relation to patient safety.
  
  The concept of safety measure cost must be taken into account to remain realistic. It may result in different forms of compromise depending on how rich the country is, so ensuring the best compromise in favour of the user, taking account of resources and of what is available at local and national levels. This point is often regarded as a goal not fully achieved (Ovretveit & Gufstason, 2002; Shaw, 2001, 2004, opus quoted), but it becomes major once there is the possibility of international implementation in countries with different levels of revenues and health systems. Problems may arise with product-based improvement plans (prion control, endoscope protection) or more strategic plans (which require more human and material resources than a country can provide)



• (ii) the cost-efficacy of the external audit to demonstrate the system's validity.
  
  From the clinical specialist's point of view, the auditing system can rapidly take up too much time and resources (to the detriment of their clinical work), or consume an excessive amount of resources in absolute terms 4 . The USA is often cited as a country with a very high global healthcare cost, and a very high cost of self-assessment, which is seen as excessive 5 .

2.1.4. Coordination of internal and external audit approaches

• There are an increasing number of both internal and external audits of the healthcare system. What can be seen as an advantage can rapidly become a consumer of time and money, with reduced efficacy



• The cost of duplication and the search for efficiency represent incentives to define goals more clearly, and to make the different approaches more mutually complementary



• In particular, there is a need to make the quality and safety processes more complementary. The quality process emphasises traceability, stability, improvement and efficacy of a care process, while the safety initiative emphasises superficial and root causes of care process destabilisation, and avoiding accidents by developing, as and when required, barriers for prevention and mechanisms of recovery or attenuation



• Reactions to a local event (reactive governance) and long-term safety policy (proactive governance) also need to be more complementary


• A nation, a healthcare system or even an HCO may use a number of approaches, requiring a high level of mutual coordination of external audits as well as coordination with internal audits, in order to become effective and comprehensible to the public. Coordination is itself a sub-objective of auditing

2.2. Patient safety initiative targets, development of initiatives
2.2.1 A progressive change in focus

Whatever process is chosen to carry out external audit, the published data trace four phases of development of the content of safety audits. These phases often overlap to various degrees in different auditing programs.

a) The oldest movement, which started before the 1990s, corresponds to the physical safety of goods and individuals:


• safety of technical areas in hospitals (firebreaks, electricity (circuit breakers and emergency supply), water (Legionella), etc.


• measuring systems (equipment calibration, critical equipment maintenance, biomedical vigilance in the wider sense),


• processes of storage and physical transformation of consumables (food, medicines, etc.).

This area can be well covered by ISO standards and by quality assurance. It could almost be regarded as outside the scope of patient safety or safety of care as it is so basic. However, it remains important both because it is a prerequisite and because it involves quality professionals, who are often not doctors, and whose role gradually extends into other areas more specific to safety of care.

b) The second movement, dating from the end of the 1990s or the beginning of the 2000s, focuses on clinical prevention standards (clinical governance). These include good care practice (keeping a care record, traceability of medical orders, prophylaxis against infection, prophylaxis against thrombosis, early treatment of myocardial infarction, blood management, various forms of prophylaxis). Producing sets of standards, and reinforced voluntary and compulsory feedback systems (such as vigilance systems) are the two classical approaches used. A quality improvement initiative is often the key initiative to measure progress made.

Accreditation is well suited to this movement, which is mainly carried out by medical staff 6 .

c) The third movement introduces the concept of dynamic interfaces, informing patients and patient participation, and transparency. It includes:

• Patient and drug flow circuits, management of the interfaces within the hospital and between hospitals, monitoring of care and consistency of discharge prescribing (reconciliation) - shared care networks.


• Quality and maintenance / management of skills of those involved (nurses and doctors).


• Information for patients, transparency, participation by the patient in their own care and in the reporting of problems.

Few external audit tools make it possible to really ensure that these dynamic points are functioning well. A quality initiative is pushed to its limits. Peer reviews (skills of those involved), audits and inspections (occasional tests) are probably to be recommended. In theory, accreditation could have a role, but the sets of standards are not complete, and the real situation is difficult to verify 7 .

d) Finally, the last movement, the most recent and one which is still being constructed, concentrates on global management of safety, a systemic approach, and the culture of safety


• Global management of medical safety is currently being deployed in a number of countries, notably the United Kingdom 8 , and is based on four areas of action:


• Commitment by top management, in particular mentioning the importance of a senior member of staff responsible for patient safety at the highest level in the HCO 9 .


• A proactive approach to risk, which does not confine itself to reacting to superficial causes identified in feedback as causing problems (the 'react to what happened' approach), but analyses and attacks the root causes of risks in the system.


• A sophisticated and multifaceted feedback system.


• An approach focusing on the responsibility and action of the actors, from top management to front-line staff, with particular emphasis on resilience strategies (robustness to destabilisation of the system, strategies of sacrifices between competing and
  contradictory goals, and crisis management) 10 .

2.2.2 Auditing the medical staff's competence is traditionally outside the scope of external auditing, but... credentialing and privileging may represent an alternative solution

The external processing is not supposed to control the competences of the individual health care professionals. However, several countries including USA, Australia and Canada are asking the HCOs to demonstrate:

• first that their staffs have the proper level of competence for the types of cares and medical protocols delivered in the HCO (concept of privileging),


• second that actions are actively taken to maintain these specific competences via appropriate training and tutoring. For example, these privileges and credentials are part of the JCAHO accreditation program.

These credentials are provided by the HCOs and differ from the accreditation of post MD medical training programs (like the work done by the US ACGME-Accreditation Council for Graduate Medical Education) and from voluntary or mandatory doctors' accreditation programs (like the new French Program of Accreditation des médecins et des équipes médicales made by HAS - dating July 2006). see for example: - the ANAES 1996 report "Mise en place d'un programme d'amélioration de la qualité dans un établissement de santé", ["Implementing a quality improvement programme"], published in French only, available here - or the AHRQ 2001 report, "Making Health Care Safer. A Critical Analysis of Patient Safety Practices". AHRQ Publication No. 01-E057., available here