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Exploring patient participation in reducing health-care-related safety risks

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ANNEX 1.<br />

QUOTATIONS FROM INTERNATIONAL<br />

LEGISLATION<br />

1 – Council of Europe, Recommendation 2006/7<br />

From the recommendation<br />

Recommends that governments of Member States, accord<strong>in</strong>g to their competencies:<br />

(i) ensure that <strong>patient</strong> <strong>safety</strong> is the cornerstone of all relevant <strong>health</strong> policies, <strong>in</strong><br />

particular policies to improve quality;<br />

[…]<br />

(iii) promote the development of a report<strong>in</strong>g system for <strong>patient</strong> <strong>safety</strong> <strong>in</strong>cidents <strong>in</strong><br />

order to enhance <strong>patient</strong> <strong>safety</strong> by learn<strong>in</strong>g from such <strong>in</strong>cidents; this system<br />

should:<br />

(a) be non-punitive and fair <strong>in</strong> purpose;<br />

(b) be <strong>in</strong>dependent of other regulatory processes;<br />

(c) be designed <strong>in</strong> such a way as to encourage <strong>health</strong> <strong>care</strong> providers and <strong>health</strong><br />

<strong>care</strong> personnel to report <strong>safety</strong> <strong>in</strong>cidents (for <strong>in</strong>stance, wherever possible,<br />

report<strong>in</strong>g should be voluntary, anonymous and confidential);<br />

(d) set out a system for collect<strong>in</strong>g and analys<strong>in</strong>g reports of adverse events locally<br />

and, when the need arises, aggregated at a regional or national level, with the aim of<br />

improv<strong>in</strong>g <strong>patient</strong> <strong>safety</strong> – for this purpose, resources must be specifically allocated;<br />

(e) <strong>in</strong>volve both private and public sectors;<br />

(f ) facilitate the <strong>in</strong>volvement of <strong>patient</strong>s, their relatives and all other <strong>in</strong>formal<br />

<strong>care</strong>givers <strong>in</strong> all aspects of activities relat<strong>in</strong>g to <strong>patient</strong> <strong>safety</strong>, <strong>in</strong>clud<strong>in</strong>g report<strong>in</strong>g<br />

of <strong>patient</strong> <strong>safety</strong> <strong>in</strong>cidents;<br />

(iv) review the role of other exist<strong>in</strong>g data sources, such as <strong>patient</strong> compla<strong>in</strong>ts<br />

and compensation systems, cl<strong>in</strong>ical databases and monitor<strong>in</strong>g systems as a<br />

complementary source of <strong>in</strong>formation on <strong>patient</strong> <strong>safety</strong> (…)<br />

From the appendix to the recommendation<br />

D.1.2. Incident report<strong>in</strong>g systems are not <strong>in</strong>tended to identify and punish the <strong>in</strong>dividual<br />

staff members <strong>in</strong>volved <strong>in</strong> <strong>patient</strong> <strong>safety</strong> <strong>in</strong>cidents.<br />

D.1.11. When design<strong>in</strong>g <strong>patient</strong> <strong>safety</strong> <strong>in</strong>cident report<strong>in</strong>g systems it may be an advantage<br />

to have <strong>in</strong> place a compla<strong>in</strong>ts system, a <strong>patient</strong> compensation system and a<br />

supervisory body for <strong>health</strong> professionals. These should complement the <strong>patient</strong><br />

<strong>safety</strong> <strong>in</strong>cident report<strong>in</strong>g system, and together these systems would form an<br />

overall <strong>in</strong>tegrated system for manag<strong>in</strong>g <strong>risks</strong> – both “cl<strong>in</strong>ical” and “non-cl<strong>in</strong>ical”.<br />

J.3. Legal approaches regard<strong>in</strong>g <strong>patient</strong>s’ rights should:<br />

Quotations from <strong>in</strong>ternational legislation<br />

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