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#2176 (no title)
Home
About
History
Haemovigilance
Mission, Vision & Strategic goals
Board
Committees
Statutes
Wall of Fame
News
Membership
Current members
Join us
Member login
Seminars
Host an IHN seminar
2023 Virtual mini-seminar (7 March)
2022 Brighton
2022 Virtual mini-seminar (29 March)
2021 Virtual mini-seminar (28 September)
2021 Virtual Mini-seminar (18 March)
2018 Manchester
2016 Paris
2014 Barcelona
2013 Brussels
2012 Montréal
Conferences with IHN Participation
ISTARE
How to participate
ISTARE related publications
Access to ISTARE
Resources
Downloads / Publications
Establishing an HV program
Grants and Scholarships
Links
Contact
#2176 (no title)
Email us
IHN member haemovigilance systems (HVS): Information about methods/situation for better understanding of their outputs
Form completed by (please provide email address; this will only be used by IHN to contact you in the event of queries about the responses)
Country (or region)
HVS website (please provide link to online reports, if available)
GENERAL - HAEMOVIGILANCE (HV) SYSTEM
Is there a HV system at blood establishment/regional/national level in your country?
Yes
No
(If national) how many years ago was a national haemovigilance system established?
1-4
5-9
10-19
20 or more
Select year or select option (number of years before date of filling in form)
(If national) When the national haemovigilance system first started, did it collect data on recipient haemovigilance, donor haemovigilance or both?
A. recipient haemovigilance
B donor haemovigilance
C both
D other, please explain
D other, please explain
Please answer the questions below about the national HV system. If there is no national HV system but there is a regional HV system, answer about the regional system.
Is the HV system managed by national (or regional) authority, blood service, professional expert body, other?
A national (or regional) health authority
B blood service
C professional expert body
D Other, please explain
Select one option
D Other, please explain
What was (were) the reason(s) for setting up the HV system?
A Set up in response to national legislation
B Set up in response to EU legislation
C At the initiative of healthcare professionals
D Other (please explain)
Select (one or more).
D Other, please explain
Is reporting
A mandatory
B professionally mandated
C voluntary
D differently
Select one option (please describe)
Please describe
Do the reporters send the reports on paper? on an electronic form? directly into a database? or an other method?
A paper form/fax
B electronic reporting form
C other method
Please explain
Please give details (optional question). Is there a reporting system for medical device (including reagents) problems?
Yes
No
If yes, are HV reports and reports about medical devices (including reagents) system sent to the same authority?
Yes
No
Is there a reporting system for pharmacovigilance?
Yes
No
If yes, are HV reports and pharmacovigilance reports sent to the same authority?
Yes
No
Add comment
ORGANISATION OF TRANSFUSION SERVICES
In your country, how many blood establishments are there which collect whole blood, red blood cells or platelets by apheresis and/or plasma? (Please include independent blood establishments as well as hospital-based blood establishments which collect blood. Please also include establishments which collect plasma only. Count the organisations; do not count all their collection sites separately)
A 1
B 2-10
C 11-50
D 51-200
E 201-1000
F >1000
Which organisation(s) is/are responsible for component selection for individual patients
A hospital transfusion laboratories, also called hospital blood banks=HBB
B independent blood establishment(s)
C both
D other arrangement
Please comment
TRANSFUSION REACTION REPORTING
Does the HV system collect information on recipient adverse reactions (transfusion reactions)?
Yes
No
Do you have standardised definitions for transfusion reactions?
Yes
No
Do you use internationally endorsed definitions (e.g. ISBT-IHN definitions for non-infectious transfusion reaction)?
Yes
No
If yes, please explain: which set(s) and are there adaptations?
Who sends the report to the HVS?
Please describe how a report of a reaction that takes place in a patient in a hospital ward reaches you in your haemovigilance organisation.
Please briefly outline all the steps and people involved.
If there is a transfusion reaction, which organisation performs the extra blood testing?
A hospital/hospital transfusion laboratory
B blood establishment
C reference laboratory
D other
In (suspected) transfusion-transmitted infections: which organisation performs investigations?
Please describe.
Does the HV system collect only serious reports or all severity levels?
A all severity levels
B serious only
C Other (explain)
C Other, explain
Does the HV system collect all imputability levels including:
not assessable
excluded
unlikely or only definite
probable
possible
Tick each level for Yes; comment at end (optional).
Please comment
How are reports checked at national level and validated? (please give brief description)
Do you have a panel or committee of experts, or equivalent?
Yes
No
Is the reported type of reaction assigned by the reporting hospital or laboratory or at the level of the HV agency?
A reporting hospital or laboratory
B at the level of the HV agency
Are reports verified (validated) based on accompanying information: all, or all serious cases?
A all submitted reports are verified
B all serious cases are verified based on accompanying information
C other (please explain)
C Other, explain
Do you conduct separate analyses for certain patient (sub)groups e.g. pediatric transfusion reactions, multi-transfused patients such as transfusion dependent thalassemia?
Yes
No
Additional explanation
Reports relating to (medicinal) SD-plasma* - does the HV system collect information about reactions and/or errors associated with (medicinal) SD-plasma? *SD-plasma=pathogen reduced pooled solvent-detergent treated plasma (e.g. Octaplas®)
A SD-plasma is not available in our country
B No, reports of reactions and/or errors go to the pharmacovigilance agency
C Yes, reports of reactions and/or errors are sent to the haemovigilance system
D Other
Does the HV system collect information about reactions and/or errors associated with use of reinfusion drains, blood warmers, etc
Yes
No
Do you receive reports from clinical staff/transfusion facilities regarding iron overload?
No
Yes, please describe with cases
Please describe with cases or add other comment
REPORTING OF INCIDENTS AND FAILURES
Does the HV system collect information about errors/incidents?
Yes
No
Explanation
Are staff able to participate in haemovigilance reporting without fear of being punished?
Yes
No
Explanation
Is the information in the haemovigilance system protected from use in a disciplinary process, if there is one?
Yes
No
Does the HV system collect information about 'near miss' events or transfusion errors which did not lead to harm?
Yes
No
Are there near miss events that should be reported as serious (e.g. if inappropriate blood/blood components have been issued/distributed for use, even if not used.)
Yes
No
When incidents are reported, does the HV system collect information about findings of incident investigation?
Yes
No
Please describe the incident investigation processes and reporting e.g. is investigiation done within the establishment or externally (HV system, inspectors, etc)?
Does the HV system collect information about adverse consequences where transfusion was a) delayed or b) not given although it should have been, because of an error/incident?
A Yes
B No
Explanation
In your country, does national level monitoring of appropriateness of transfusions take place, e.g. through Hb levels before / after, INR or platelet counts?
No
Yes, monitored nationally
Maybe at hospital level
Don't know; Comment
Comment
Does the HV system collect information about unnecessary (avoidable) transfusions because of error/incident (e.g. because of wrong Hb)?
Yes
No
Does the HV system collect information about shortages, when stocks of any of the following run out at national or regional level (blood collection bags, test kits for transfusion-transmissible infections, test kits for routine blood grouping, others)?
Yes
No
Explanation
In your country, do shortages of blood and blood components occur?
Yes
No
DONOR HAEMOVIGILANCE
Does the system collect information on blood donor adverse reactions?
Yes
No
Does the system collect information on errors/incidents associated with blood (component) donation, even if there was no harm? (E.g. misidentification of a donor; apheresis procedure using incorrect IV solution)
Yes
No
Explanation
Do you utilise standardised definitions for blood donor adverse reactions?
Yes
No
Do you use the ISBT-IHN-AABB definitions for donor complications)? https://www.isbtweb.org/fileadmin/user_upload/Donor_Standard_Definitions_Final_2014.pdf
Yes
No
Has the 2020 severity grading tool for donor adverse reactions been implemented?
Yes
No
Explanation
Does the HV system collect only serious reports of donor adverse reactions or all severity levels?
Yes
No
Is the imputability of donor adverse reactions reported?
Yes, all DAR
Yes, but only for serious DAR
Yes, for …
No
Do you collect:
all imputability levels
only definite
probable
possible
Tick which imputability levels are collected
Explanation
Do you have a panel or committee of experts (or equivalent) who review serious DAR?
yes, at HV system level
yes, at blood establishment
maybe at blood establishment
other
Select all which apply.
Other, please describe
How are donor adverse reactions checked and validated?
Are abnormal ferritin values or deferrals due to iron deficiency reported?
No
Yes (please describe)
If yes, please describe
Does the HV system receive information about donor adverse reactions from all blood establishments including private sector plasma collectors?
yes, all DAR
yes, but only for serious DAR
no private sector plasma collections
other (describe)
Select all which apply.
Other, please describe
Add comment
FEEDBACK AND RECOMMENDATIONS
Is information about the reported transfusion reactions reported publicly, e.g. in an annual report?
Yes
No
Explanation
Is information about the reported blood donation complications reported publicly, e.g. in an annual report?
Yes
No
Explanation
Does the HV system make recommendations for improving safety?
Yes
No
Explanation
Can the HV system issue an alert to the blood bank or clinicians about an important issue, e.g. a serious reaction following an unsafe practice?
Yes
No
Explanation
Please give a recent example (if applicable)
Apart from publishing a report with recommendations (if the HV system does this), what other routes do you have for disseminating recommendations?
Additional comments:
SOME FIGURES
Total population of country/region (millions)
Profile of donations (give approximate %)
Voluntary non-remunerated, replacement, autologous predeposit.
Estimated national total of units distributed/transfused (each unit should only be counted once, even if issued more than once before actual transfusion)
A <10,000
B 10,000 to 50,000
C 50,000-500,000
D 500,000-1M
E 1M or more
Comment, optional, about availability of national figures for units
What percentage of hospitals is covered by HV reporting?
Optional, please estimate.
Add Comment
How (i.e. by which organisation(s)) is traceability confirmed in your country?
Is confirmation of transfusion based on
A bags returned to issuing facility
B returned transfusion slips/cards
C electronic confirmation at bedside
D other
Select one or more.
Comment, e.g. is the traceability percentage of components with transfusion (or final disposal) confirmed known at national/regional level?
DEVELOPMENTS - CHALLENGES - FINAL COMMENTS (optional)
Please list up to 3 challenges relating to transfusion in your country (e.g. traceability - shortages of reagents for testing of donations)
Please list up to 3 areas where changes are expected in your country or the HVS in the next five years (e.g. move to electronic reporting - starting to include donor haemovigilance)
Please share any comments about this survey or about data collection by IHN (regular basis and/or for defined projects/studies)
