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Appendix D. Data sources – Reporting systems

The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,

Considering that the aim of the Council of Europe is to achieve a greater unity between its members and that this aim may be pursued in particular by the adoption of common rules in the health field;

Considering that access to safe health care is the basic right of every citizen in all member states;

Recognising that although error is inherent in all fields of human activity, it is however possible to learn from mistakes and to prevent their reoccurrence and that health-care providers and organisations that have achieved a high level of safety have the capacity to acknowledge errors and learn from them;

Considering that patients should participate in decisions about their health care, and recognising that those working in health-care systems should provide them with adequate and clear information about potential risks and their consequences, in order to obtain their informed consent to treatment;

Recalling that Article 2 of the Council of Europe’s Convention on Human Rights and Biomedicine (ETS No. 164) establishes the primacy of the human being over the sole interest of society or science, and recalling its Article 3 on the equitable access to health care of appropriate quality;

Considering that the methodology for the development and implementation of patient-safety policies crosses national boundaries and that their evaluation requires substantial resources and expertise and should be shared;

Recalling its Recommendations Nos. R (97) 5 on the protection of medical data, R (97) 17 on the development and implementation of quality improvement systems (QIS) in health care, and R (2000) 5 on the development of structures for citizen and patient participation in the decision-making process affecting health care, and its Resolution ResAP(2001)2 concerning the pharmacist’s role in the framework of health security, which explicitly suggests working in partnership with other health professionals;

Noting the relevance of the World Health Organisation (WHO) “Health for All” targets for the European Region (target 2) and of its policy documents on improving health and quality of life and having regard to its Health Assembly Resolution 55.18 (2002) on “Quality of care: patient safety”, which recognises the need to promote patient safety as a fundamental principle of all health systems;

Considering that patient safety is the underpinning philosophy of quality improvement and that all possible measures should therefore be taken to organise and promote patient-safety education and quality of health-care education;

Considering that the same principles of patient safety apply equally to primary, secondary and tertiary care and to all health professions as well as to health promotion, prevention, diagnosis, treatment, rehabilitation, and other aspects of health care;

Recognising the need to promote open co-ordination of national and international regulations concerning research on patient safety,

Data sources – Reporting systems

See Appendix D (pdf-file) of Recommendation Rec(2006)7 of the Council of Europe

NOTE: text markers added to increase readability (not applied in the original).

D.1. Patient-safety incident reporting

1. The primary objective of an incident reporting system is the enhancement of patient safety, by learning from adverse events and mistakes made. Reporting and collection of incident data is meaningful only if the data is analysed and evaluated and if feedback is given to the professionals involved in the incident, and to all others who could learn from the incident.

2. Incident reporting systems are not intended to identify and punish the individual staff members involved in patient-safety incidents.

3. Incidents may be reported by health professionals, patients and relatives, or by other informal caregivers and suppliers.

4. An incident reporting system should:

a. preferably be voluntary in nature; in most instances the professional in question is the only one who knows about a near miss or an adverse event (alternatively: the system may be mandatory on the part of the institution, giving the controlling bodies an opportunity to measure the institution against a standard or an obligation). A mandatory system for individual health-care personnel could completely demotivate those directly involved in the provision of health care and who are invited to participate in such reporting systems);

b. be at least confidential; however, if the event is to be analysed in order to learn from it, the names of the personnel involved may need to be known locally (that is, inside the actual institution);

c. be anonymous, at least at regional and national levels;

d. be non-punitive with respect to those who report, but provide no immunity if supervisory bodies or legal authorities need to be informed of the event in some way, because of its consequences for the patient;

e. be objective with findings and recommendations;

f. encourage unrestricted reporting by all working in the health-care system;

g. provide incentives (for example, express recognition) for reporting;

h. receive reports of serious and fatal events caused by incidents, near misses, and hazardous situations that could have led to safety incidents;

i. be independent of regulatory or accrediting processes;

j. use a single format for the reporting of all incidents, preferably including discrete categories for onward reporting to public authorities or for separate analysis. Where a variety of reporting formats already exists, the definition of a standard set of minimal data should be agreed upon, to be used in every subsequent reporting system.

5. The greatest effect on safety and quality improvement is generated locally when the institution uses patient-safety incident reporting as part of a continuous system of safety and quality improvement:

a. local safety and quality initiatives should be promoted in all health-care units and organisations;

b. ongoing assessment of the patient-safety policy should start at the lowest level possible within the service.

6. A national framework for incident management should be defined and implemented, to capture from local systems those patient-safety incidents where national learning and action can prevent future reoccurrence. Where appropriate this information could then be shared with patient-safety organisations or government departments in the other European countries.

7. As a final goal to be reached after gaining experience at local level, a national incident reporting system should be considered: comprehensive, which should be covering all levels and areas of health-care provision, including the private sector.

8. Aggregation of data regionally, (inter)nationally will be particularly useful for uncovering systematic failures and the accumulation of certain incidents or failures in new equipment that cannot be readily identified at the local level, in other words, those which can only be revealed by a larger dataset. Rigorous methods should be used in order to guarantee representativity of the data and to minimise any possible bias. Institutions have to be equipped with appropriate resources to achieve this purpose.

9. The development of Internet-based reporting systems should make the establishment of national and European-wide safety-incident databases easier to maintain and less costly to operate.

10. Experience from different countries varies as to whether there is a need to make reporting and analysis of patient-safety incidents a legal obligation.

11. When designing patient-safety incident reporting systems it may be an advantage to have in place a complaints system, a patient compensation system and a supervisory body for health professionals. These should complement the patient-safety incident reporting system, and together these systems would form an overall integrated system for managing risks, both “clinical” and “non-clinical”.

D.2. Use of data

1. Reporting and collection of patient-safety data is meaningful only if the data is intelligently analysed and information is, where appropriate, fed back to health-care professionals, managers and patients.

2. The Root Cause Analysis process is a systematic and comprehensive means of collecting and analysing data following a patient-safety incident. It does not end at the investigative process. It also includes the design, implementation, evaluation and follow-up of improved safety systems.

3. There needs to be a clear understanding and agreement with health-care institutions and professionals on how the data collected will be put to use.

4. The collection and use of data will also need to comply with domestic & European data-protection legislation.

5. Effective data collection depends on the willingness of frontline clinical staff. The following barriers to reporting exist, which should be removed through appropriate policies:

a. fear of blame, resulting from a lack of open and fair culture;

b fear of the reports being used out of context by the media and others;

c. lack of feedback as to what has changed as a result of the report;

d. lack of time to report;

e. lack of support from the management of the organisation;

f. lack of legal protection against using the information for purposes other than learning;

g. breaches of confidentiality or anonymity leading to ineffective separation of incident reporting systems from disciplinary and regulatory bodies.

D.3. Other sources of information on patient safety

1. Patient-safety incident reporting systems can be established as “stand-alone” systems or can be integrated with systems for recording complaints and compensation claims or applications for benefits (the different sources of information will depend on the situation in each country). Each organisation should develop systems to analyse this information and to learn from it.

2. A patient-complaints system should be regarded as an instrument ensuring patient rights, but representing a minor part of reported data on patient safety:

a. complaints, criticism or suggestions, whether oral or written, made by patients or their representatives, should be taken seriously, and handled appropriately and sensitively;

b. patients should feel able to approach the staff who provided the service, and professionals should make every attempt to resolve complaints locally at an early stage;

c. the primary objective of any system is to provide the fullest possible opportunity for investigation and resolution of the complaint, as quickly as circumstances allow.

3. Clear procedures for recording and analysing patient complaints should be defined, which should be simple and integrated by all stakeholders:

a. the process should be fair, transparent, flexible and conciliatory and should be easy to access for all service users;

b. rigid, bureaucratic and legalistic approaches must be avoided.

4. In addition to patient-safety incident reporting, all other reporting systems and channels should be used to collect data. There should be a register of such sources, such as those for medical device failures, complaints, legal claims, applications for disability benefits, death inquests, and reports of adverse drug reactions: mechanisms should be introduced at regional or national level to collect this information and share the lessons learned from these systems with those able to take action.

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