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

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Blood transfusion <strong>safety</strong> <strong>in</strong> France: develop<strong>in</strong>g tools to support <strong>patient</strong>s<br />

subcommissions; under Article R1221-43, a haemovigilance correspondent <strong>in</strong><br />

each <strong>health</strong> facility must declare all adverse reactions <strong>in</strong> transfusion recipients and<br />

serious transfusion <strong>in</strong>cidents and collect <strong>in</strong>formation mentioned <strong>in</strong> articles<br />

R1221-40 and R1221-2.<br />

A simplified depiction of the transfusion and haemovigilance system at national,<br />

regional and local levels is shown <strong>in</strong> Fig. 4.6 (6).<br />

Fig . 4 .6 . Organization of transfusion and haemovigilance <strong>in</strong> France<br />

M<strong>in</strong>istry of Health<br />

National AFSSAPS<br />

Regional<br />

EFS and CTSH<br />

18 blood<br />

transfusion centres<br />

National Haemovigilance<br />

Commission<br />

29 regional haemovigilance<br />

coord<strong>in</strong>ators<br />

Local 155 transfusion sites 1 600 <strong>health</strong> <strong>care</strong> centres<br />

Health <strong>care</strong> professionals<br />

The transfusion <strong>safety</strong> and haemovigilance committees, created <strong>in</strong> 1994, are responsible<br />

for improv<strong>in</strong>g transfusion <strong>safety</strong> through research and consequent recommendations.<br />

Their duties at local level are to improve <strong>safety</strong> for transfused <strong>patient</strong>s, monitor the<br />

application of haemovigilance regulations and manage the tra<strong>in</strong><strong>in</strong>g of staff members<br />

deal<strong>in</strong>g with blood transfusion processes (10).<br />

Any <strong>health</strong> <strong>care</strong> professional who observes or becomes aware of an adverse effect or a<br />

serious <strong>in</strong>cident must report it with<strong>in</strong> eight hours. Analysis of haemovigilance data is<br />

carried out at national level.<br />

Regulatory aspects and legal tools support<strong>in</strong>g <strong>patient</strong> <strong>safety</strong> and the right to<br />

<strong>safety</strong> <strong>in</strong> France<br />

List of official legislative documents<br />

Law No. 2002-303 8 on <strong>patient</strong>s’ rights and quality of the <strong>health</strong> system came <strong>in</strong>to force<br />

<strong>in</strong> 2002. This law gives the right to every hospitalized <strong>in</strong>dividual over 18 years of age<br />

to name a trustworthy person who will back them dur<strong>in</strong>g their stay and def<strong>in</strong>es the<br />

right for <strong>patient</strong>s to access their medical records. In relation to blood transfusion, the<br />

11 January 2006 bill 9 (repealed on 1 October 2006) abolished the systematization of<br />

pre- and post-serological transfusion checks on LBP recipients.<br />

8 Loi No. 2002-303 du 4 Mars 2002; see the list of legislation at the end of this chapter.<br />

9 Circulaire DGS/DHOS/SD3/2006/11 du 11 Janvier 2006.<br />

National Institute for<br />

Public Health Surveillance<br />

Epidemiology of donors<br />

55

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