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

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Exploring patient participation in reducing health-care-related safety risks 50 Fig . 4 .3 . Transfusion procedure steps aDetermination of irregular antibodies test. Source: AFSSAPS (7). Patient to transfuse Patient identification Information to patient Consent Transfusion prescription Blood group determination – DIA a Transfusion file creation Search for previous blood transfusion Command of LBP Transportation Control of product received Preparation of equipment Patient identity check Ultimate compatibility control Transfusion Immediate monitoring Immediate traceability Incident notification Patient follow up Post-transfusion monitoring Delayed adverse events Post-transfusion information Transfused patient Adverse events and transfusion-related incidents Blood transfusion involves some risks than can relate to the quality of the blood products, the clinical profile of the recipient or the health care organization. Adverse effects are defined in the French Public Health Code (8) (Box 4.1).
Box 4 .1 . Definitions of adverse effects and incidents in French law The definitions listed here apply to the application of article R1221-23 of the French Public Health Code. Blood transfusion safety in France: developing tools to support patients 1. Adverse effect: a harmful reaction affecting donors, related (or likely to be related) to the blood collection; or affecting recipients, related (or likely to be related) to the administration of a LBP; a recipient adverse reaction (RAR) is a harmful reaction affecting a recipient, related (or likely to be related) to the administration of a LBP. 2. Serious adverse effect: an adverse event resulting in death or danger of death, resulting in disability or incapacity, or provoking or prolonging hospitalization or any other morbid condition. 3. Incident: an incident related to the collection of blood, biological qualification of donations, preparation, storage, distribution, issue or use of a LBP, due to an accident or error, likely to affect the safety or quality of the product and result in adverse events. 4. Serious incident: an incident likely to result in serious adverse effects. Severity of RARs is defined by different grades: » Grade 4: death of the recipient » Grade 3: immediate danger of death » Grade 2: long-term morbidity » Grade 1: absence of immediate or long-term danger of death » Grade 0 (introduced in 2002–2004): isolated dysfunction without clinical or biological manifestation. Imputability of RARs is defined as the probability that an adverse reaction affecting a LBP recipient be attributed to the products transfused, or that an adverse effect affecting a blood donor be attributed to the collection of blood or blood components; by definition, imputability does not apply to chain incidents. For each adverse effect declaration, a case-by-case analysis should enable a causal link to be established between the transfusion of the LBP and the occurrence of the adverse effect. The imputability levels are classified according to the following criteria. » Imputability 4 – certain: the tests prove that the adverse event was caused by the transfusion. » Imputability 3 – likely: the adverse event does not appear to be accounted for by a concurrent cause and diagnostic information that suggests the adverse effect was caused by the transfusion remains. » Imputability 2 – possible: the adverse effect could be accounted for either by the transfusion or a concurrent cause without it being possible to decide at the current stage of investigation. » Imputability 1 – doubtful: the adverse event does not seem to be fully accounted for by the administration of the LBP, although it is not possible to totally exclude this. » Imputability 0 – excluded: it was proven that the LBP was not involved in the occurrence of the adverse effect. The AFSSAPS is responsible for the compilation of haemovigilance data. According to the 2009 annual haemovigilance report (6), 7808 adverse reactions occurred among recipients of blood, representing 2.6 per 1000 LBPs. A typology of the different risks and latest available data are given in Table 4.1. Fig. 4.4 provides additional information about the distribution of adverse reactions related to blood transfusion; further figures can be found in the AFSSAPS 2009 annual haemovigilance report (6). The frequency of adverse events increases with age, with 60% of the grade 3 or 4 adverse reactions declared in 2009 in patients aged over 60 years and 24% in those over 80. Patient safety in France: an overview Patient safety is defined as being free from unnecessary or potential harm associated with health care. 51
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Exploring patient participation in
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ABSTRACT Patients’ rights have be
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iv Patient information: the link be
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vi LIST OF TABLES, FIGURES AND BOXE
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ACKNOWLEDGEMENTS The editors would
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LIST OF ABBREVIATIONS ABHR alcohol-
Page 13 and 14: FOREWORD Health is a social value a
Page 15 and 16: ChApTER 1. pATIENTS’ RIGhTS AND p
Page 17 and 18: Box 1 .1 . contd Reporting and Lear
Page 19 and 20: The causal mechanisms through which
Page 21 and 22: » be involved in routine monitorin
Page 23 and 24: elationships within the complex env
Page 25 and 26: ChApTER 2. pATIENTS’ RIGhTS AND p
Page 27 and 28: CoE Recommendation 2006/7 of the Co
Page 29 and 30: The 2005 United States act on patie
Page 31 and 32: The right to participate in policy-
Page 33 and 34: The right to participate in quality
Page 35 and 36: » engaging with patient representa
Page 37 and 38: hampered by the written and spoken
Page 39 and 40: prevents misunderstandings and shap
Page 41 and 42: Health care providers should nevert
Page 43 and 44: Recommendation 7 - Encourage the av
Page 45 and 46: 20. Constitution of the World Healt
Page 47 and 48: ChApTER 3. pATIENT pARTICIpATION IN
Page 49 and 50: awareness of the sociomedical burde
Page 51 and 52: Patient participation in hand hygie
Page 61 and 62: Blood transfusion safety in France:
Page 63: Blood transfusion safety in France:
Page 67 and 68: Fig . 4 .4 . Distribution of advers
Page 73 and 74: The heterogeneity of situations and
Page 83 and 84: Fig . 4 .12 . Patients’ response
Page 91 and 92: Patient safety, rights and medicati
Page 97 and 98: Fig . 5 .3 . Frequency with which d
Page 107 and 108: ChApTER 6. pATIENT pARTICIpATION IN
Page 109 and 110: Patient participation in elective s
Page 111 and 112: e desirable to have a special statu
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Patient participation in elective s
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inspections of surgical services to
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» being involved in monitoring and
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Other studies on patient attitudes
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Information about patients’ exper
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available evidence suggests that in
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Adverse events Respondents from the
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Feeling safe Five per cent of hospi
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probability proportional to populat
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care professionals’ and patients
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group recommends that patient invol
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13. Hibbard JH et al. Can patients
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52. Triemstra M et al. Measuring cl
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2009 (http://www.bradfordresearch.n
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of a small-scale patient survey add
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Box 8 .2 . Curricula and CME Chapte
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is provided through interaction of
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Box 8 .4 . Patient education Chapte
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ANNEX 1. QUOTATIONS FROM INTERNATIO
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(2) When designing adverse event re
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17) If yes, do you think this was m
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Box A3 .1 . Reporting procedure Pat
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Box A3 .2 . contd Haemosiderosis Ha
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ANNEX 4. pATIENT QUESTIONNAIRE ABOU
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ANNEX 6. WhO pATIENT SAFETY pROGRAM
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especially those in intensive care.
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ANNEX 7. hANDOVER pROjECT Paul Bara
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(a) Provide new insight into the ro
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Johnson J, Barach P. Handovers of p
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Enhancing the patients’ role in p
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Enhancing the patients’ role in p
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Exploring patient participation in reducing health-care-related safety risks

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