setting up a hemoviligance system in a hospital network · management of blood product inventory...
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Setting up a hemoviligance
system in a hospital network
XIV International Hemovigilance Seminar
April 2012
Ginette Labonté, RN
Anne-Marie Martel, RN
Clinical Transfusion Safety Officers
Introduction
Different committees were formed to optimize the security
and quality of transfusion practice throughout the province.
To improve transfusion practice, roles and responsibilities
were established for all professionals involved in blood
product management, from the donation to the recipient.
In 1999, TSO positions were formally created to coordinate
transfusion practices from a technical and clinical point of
view.
Following the 1997 report of the Krever Commission
centered on the safety of blood products, the province of
Quebec decided to reorganize the blood system.
Province of Quebec
« Designated centers » :
Hospitals that were
selected as per their
transfusion volume and
their own specialty
« Associated centers » :
Hospitals with a blood
bank. They all are
associated with the «
Designated centers»
« Affiliated centers » :
Health centers or private
medical office where blood
products may be delivered
and administered, but do
not have a blood bank
Team composition
The team goal is to provide standardized high quality transfusion medicine services
The team works in collaboration with the hematologists, nurses and blood bank technicians in the “Designated center” and the “Associated centers”
Hematologist:
Coordination and supervision of transfusion practice
Revision of policies and procedures
Adverse transfusion reaction report approval
Continuing medical education in transfusion medicine
Participates in the transfusion committee (sometimes, can chair)
Team composition
Clinical TSO
Ensures the completion of trace-back, look-back and product recall
Responsible for adverse transfusion reaction reporting
Development and correction of policies and procedures
Participates in the transfusion committee
Educational sessions for health professionals
Promotion of informed consent and notification of recipients
Assists in implantation of the computer information system (SIIATH) on patient care units when required
Technical TSO
Development and correction of policies and procedures
Management of blood product inventory
Participates in the transfusion committee
Educational sessions for blood bank technicians
Development of new techniques
Coordinates the implantation and maintenance of the information system (SIIATH)
in all centres
Signed contract between parties (designated and associated centers)
•Harmonization of policies and procedures in transfusion
medicine
•Regulation of blood bank activities and management
•Establishment of professional responsibilities
•Optimization of human, material and financial resources
•Ensure accessibility and quality of transfusion services
Evaluation of clinical and laboratory services by the transfusion safety officers
Recommendation to harmonize policies and procedures with the
“Designated center” as per the Canadian standards
Organization
Clinical TSO responsibilities
Establish and coordinate the implementation of a
quality assurance program to maintain and improve
transfusion medicine practice
In collaboration with the technical TSO, ensure communication between health professionals and blood banks
Clinical TSO responsibilities
« Policies and Procedures »
Develop policies and procedures to improve and standardize clinical practice in transfusion medicine
Distribute and promote these policies and procedures in hospitals : « Designated center » and « Associated centers »
Verify adherence to policies and procedures
Clinical TSO responsibilities «Evaluation and review of transfusion competency »
Retrospective audits to verify the compliance to implemented procedures
Instigate corrective actions in response to nonconformities identified during an internal audit
Ensure follow-up on these corrective actions
In collaboration with the regional transfusion medicine committee and the medical director, ensure the proper use of blood, blood products and blood components by nurses and physicians
Clinical TSO responsibilities
« Training and continuing education »
When a major change in procedure is suggested by the
“Designated center” and approved by the hematologist
responsible in the “Associated center”, the clinical TSO
offers educational sessions for:
Nurses
Respiratory therapists (in OR)
May include physicians in some facilities
Blood specimen identification
Transfusion administration (including verification and surveillance)
Adverse transfusion reactions (recognition, treatment and reporting)
Appropriate use of blood , blood products and blood components
Information on risks and benefits of blood transfusion
including all the alternatives
RIAT (Quebec hemovigilance software)
SIIATH (Quebec blood bank computer system)
Clinical TSO responsibilities
« Training and continuing education »
Aviser banque de sang
2 accès veineux #14 ou Cordis
SOINS INFIRMIERS
BANQUE DE SANG
MÉDECIN
PRÉPOSÉ AU
BÉNÉFICIAIRE
Favoriser la réplétion volémique
avec cristallloïdes ou colloïdes
Produits sanguins
Hémostase des sites de
saignement
Paramètres ciblés
Viser fibrinogène > 1.0 g/L.
Si non corrigé par plasma, donner cryoprécipités,
8-12 U chez l’adulte (1 U/7-10kg)
Maintenir Ca ionisé > 1,13 mmol/L
Chlorure de Ca 1g IV lentement
Viser Plt> 50 X 109/L
Viser Plt> 100 X 109/L si hémorragie du CNS ou si
Thrombopathie (ex: ASA, Plavix)
Maintenir le Mg > 0,70 mmol/L
Viser Hb 80-100 g/L
Maintenir le pH >7,2
Viser PT et PTT < 1,5 X la normale
Patient sous héparine non
fractionnée à doses
thérapeutiques
Patient sous héparine de bas
poids moléculaire (HFPM)
Patient sous Coumadin
Vitamine K 10 mg IV
4-6 plasmas (12-15 mL/kg)
Considérer complexe de prothrombine PRN
(doit être commandé à Héma-Québec)
Protamine 50 mg IV en 10 min.
Si administré dans les 8-12 heures:
25 mg de Protamine IV
Si administré dans les 8 heures:
50 mg de Protamine IV
Si administré plus de 12 heures:
Pas de Protamine
Prélèvements
AVISER LA BANQUE DE SANG
DE L’ARRÊT DU PROCESSUS
Réchauffe-sang
Solutés préchauffés
Sacs à pression
Couverture chauffante
Q 4 culots
(ou q 2 heures ad fin)STAT
Groupe sanguin
Hb-Ht, plaquettes
K+, Ca ionisé,
Mg, INR, PTT,
fibrinogène
Hb-Ht, plaquette
ou FSC
Gaz artériel
K+, Ca ionisé, Mg
INR, PTT,
fibrinogène
Saignement persiste malgré les
paramètres ciblés atteints
Considérer DDAVP 0,3 µg/kg IV
X 1 dose si patient urémique
ou connu pour Von Willebrand
Considérer Cyclokapron 10 mg/kg IV si
suspicion fibrinolyse
(note: contre-indication absolue si saignement
au niveau urinaire).
Consulter l’hématologue
Considérer l’utilisation du rFVIIa
(voir protocole de transfusion massive)
Disponibilité durant
toute la procédure
Assurer le transport
des produits
sanguins et
matériel requis
Algorithme sur la transfusion massive
Activer procédure:
« Demande produit
sanguin en urgence »
Étape 1 0 minute
Distribuer 4 culots
Étape 5 120 minutes
Si poursuite du
protocole:
Retour à l’étape 3
Étape 2 30 minutes
Distribuer 4 culots
et 3 plasmas
Étape 490 minutes
Distribuer 4 culots
et 3 plasmas.
Communiquer avec
l’équipe traitante pour
la poursuite du
protocole.
Étape 3 60 minutes
Distribuer 4 culots,
3 plasmas,
5 unités de plaquettes*
et 10 unités de
cryoprécipités*Pour les établissements qui n’ont pas
de réserve de plaquettes, cette étape
sera retardée en raison du transport
Dr Susan Fox
Dr Céline Devaux
Ginette Labonté
Anne-Marie Martel
Chantal Robinson
Chargées de sécurité transfusionnelle
Étape 1
0 minute Étape 2
30 minutes Étape 3
60 minutes Étape 4
90 minutes Étape 5
120 minutes
Culots 4 4 4 4
Plasma 3 3 3
Plaquettes* 5*
Cryoprécipités 10
Si poursuite du protocole :
Retour à l’étape 3
*Pour les établissements qui n’ont pas de réserve de plaquettes, cette étape sera retardée en raison du transport
En tout temps, il est possible de commander des produits sanguins supplémentaires
Clinical TSO responsibilities
« Training and continuing education »
In our region
Periodic information bulletin on
various topics of interest in
transfusion medicine
Clinical TSO responsibilities
« Training and continuing education »
Clinical TSO responsibilities
« Training and continuing education »
Clinical TSO responsibilities
« Investigations »
Ensure blood, blood product and blood component
traceability :
Trace Back
Public Health Agency
Hema-Quebec
RAMQ (Quebec’s Health Insurance)
Look Back
Hema-Quebec
Product recall
Investigate patient’s file if the product has
been transfused before the recall from Hema-
Quebec to make sure that it did not cause any
health problem to the recipient
On a 3 year cycle, every facility in the
province of Quebec must go through the
accreditation process
Accreditation
- Canadian Standards Association
- Canadian Society for Transfusion Medicine
« Accreditation Canada is the organization
responsible to routinely assess and review the
accreditation program to ensure it addresses the
specialized needs of the ever-changing health care
environment »
Accreditation
SIIATH
SIIATH
SIIATH
« Sommaire transfusionnel »
« Sommaire transfusionnel »
Notification of transfusion
RIAT
In the province of Quebec, there is a computer system which enables the TSOs to document and report adverse events related to transfusion
RIAT (Rapport d’Incidents Accidents Transfusionnels) is the notification system.
Incident: Any error during the process (“near miss”), which could result in an adverse transfusion reaction if not detected prior to transfusion.
Accident: All adverse transfusion reactions or errors associated with transfusion.
The system was set up in 1999 and has evolved since.
Most of the hospitals in Quebec are connected to the software
RIAT
Role of the clinical TSO
Investigation of patient files related
to adverse transfusion reactions
Resource person for RIAT in
« Associated centers »
Review and approval of RIAT for
« Associated centers »
Evolution in adverse transfusion reactions’reporting
NHFR and minor allergic reaction
24
6,4
14
3,7
19
1,1
14
8,5
71
,3
75
,0
12
6,2
10
2,9
13
8,1
18
6,8
15
5,0
27
4,1
17
2,8
29
2,9
16
7,1
20
0,4
16
1,3
21
3,4
14
4,7
18
6,1
0,0
50,0
100,0
150,0
200,0
250,0
300,0
RFNH R. all. mineure
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Major allergic reaction and fluid overload
23
,9
10
,0
31
,6
6,2
23
,1
8,5 9
,710
,9
21
,8
18
,6
15
,9
11
,2
27
,5
10
,8
8,7
27
,0
9,8
33
,5
29
,8
6,2
0,0
5,0
10,0
15,0
20,0
25,0
30,0
35,0
R. all. Majeure Surcharge vol.
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
ABO inc., IHR, DHR
PRBC
3,4
8,4
9,5
1,9
4,8
2,4
2,3
7,7
0,5
3,7 4
,2
7,2 7
,9
11
,5
2,1
10
,5
4,9
6,3
3,1
14
,4
8,5
6,0
3,0
5,1
3,7
4,5
2,3 2
,8
3,7
1,7
0,0
2,5
5,0
7,5
10,0
12,5
15,0
Inc ABO RHI RHR
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Taux
Sommaire transfusionnel
3,63
4,51
10,39
0,94
4,71
1,41
0
3
5
8
10
Inc ABO RHI RHR
PRE POST
p=0.012 p=0.03
p=0.006
Ratio par
100,000 culots
Recognition of the symptoms by the nurseReport to blood bank
Depending on the symptoms, blood work
Blook bank (24/7)
Depending on the symptoms
Clinical TSO or collaborator
Notify Hema-Quebec
Blood components culture
Patient’s chart investigation
RIAT
Results sent to Hema-Quebec
As per the conclusion, clinical TSO will send a preliminary report to
Hema-Quebec and/or Health Canada
Approval by clinical TSO
Approval by haematologist
Provincial approval by INSPQ
Final report to patient’s chart (and Hema-Quebec if applicable)
RIAT
How it works in our region
A collaborative process
Regional and provincial collaboration
Exchange of information
Communication between facilities
Health professional
Blood bank technician
Blood supplier
Etc…
Canadian collaboration
In Canada, the creation of a Website
and a mailing list enables interaction
between all the TSOs of the country
www.transfusionsafety.ca
Conclusion
TSOs play a significant key role in the improvement of tranfusion practice safety
However, safe transfusion practice cannot only be the responsibility of health professionals. The system requires up-to-date tools and technology.
In fact, despite the efforts of the hematologists in
charge of blood banks and the TSOs, many of
reported incidents associated with human errors
could be prevented by electronic identification of
transfusion recipients
A work in progress
Provincial standardization of policies and
procedures in transfusion medicine
Electronic identification
Certification program for health professionals
involved in transfusion medicine
THANKS
Dr Susan Fox
Anne-Marie Martel
References
Comité d’hémovigilance du Québec. Rapports 2010, MSSS
Accreditation Canada http://www.accreditation-canada.ca/default.aspx
Complications transfusionnelles au Québec, INSPQ, 2010
Comité d’hémovigilance du Québec, http://www.msss.gouv.qc.ca/hemovigilance/
Standards For Hospital Transfusion Services, CSTM, Version 2, September 2011
CSA Standard, CAN/CSA-Z902-04, Blood and blood components, November 2010
Th
an
k y
ou
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