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

Exploring patient participation in reducing health-care-related safety risks
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Haemovigilance
Article R1221-27 of the Public Health Code (8) states that AFSSAPS should produce
an annual summary report on haemovigilance, which has to be adopted by the National
Haemovigilance Commission.
European Commission Directive 2004/33/EC (11) stated the need to increase donors’
awareness about the importance of post-donation information (PDI). This necessity
is reflected in the Decree of 1 February 2006 10 on haemovigilance: any information
likely to compromise the quality and safety of the LBP must be declared. A document
describing the basics of good transfusion practices 11 specifies that a post-donation
document should be given to the donor with a phone number to call to provide any
relevant information. The decision published in December 2010 12 establishes the form,
content and terms for transmitting the serious incident declaration. A similar decision
about adverse reactions occurring among blood recipients was made public in January
2007. 13 A 2003 bill 14 sets out the correct behaviour in the case of a suspected transfusion
incident by bacterial contamination.
Patients’ rights
Providing information to patients about their health is obligatory under Article
R1112-2. The patient has to be informed by the prescriber when possible and before the
transfusion. 15 The patient’s informed consent has to be obtained by the doctor before the
transfusion procedure (8,12).
Article L1111-4 of the Public Health Code (8) stipulates the following points:
» physicians must respect a patient’s will after informing them about the consequences
of their choices;
» when the patient is not able to express a decision, no intervention can be carried out
without the family or legal guardian’s agreement, except in emergency cases; and
» consent of individuals who are either under 18 years or are under the responsibility
of a guardian has to be sought consistently, whenever possible.
Patients can access their medical records (Article L1111-7) and consequently the list of
transfusion procedures they have undergone (Article R1112-2). Any patient who has
received a LBP should be informed of this in writing during their stay (Article R1112-5).
Patient information on blood transfusion: the prescriber’s legal obligations
Informing the patient about blood transfusion is a legal obligation under the Law of 4
March 2002. 16 Information is given by the prescribing doctor to the greatest extent possible
before the transfusion procedure. 15 The French Society of Anaesthesia and Intensive Care
10 Décret No. 2006-99 du 1er Février 2006.
11 Décision du 6 Novembre 2006.
12 Décision du 24 Décembre 2010.
13 Décision du 5 Janvier 2007.
14 Circulaire DGS/DHOS/AFSSAPS n° 2003-581 du 15 Décembre 2003.
15 Circulare DGS/DHOS/AFSSAPS n° 2003-582 du 15 Janvier 2003.
16 Loi No. 2002-303 du 4 Mars 2002.