Haemovigilance

Question 1

Define haemovigilance

Answer 1

A set of surveillance procedures, from the collection of blood and its components to the follow up of recipients, to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence

Question 2

Who is in charge of haemovigilance

Answer 2

Haemovigilance officer

Question 3

Who is the haemovigilance offiver

Answer 3

Medical scientist or nurse

They report on reactions and events to the NHO

They check traceability i.e. final fate of every unit

They talk to nurses and phlebotomists out on the ward

They go up into the ward and check the previous days transfusion

They ensure full traceability

Question 4

Define a reaction

Answer 4

An unintended response to the patient associated with the collection or transfusion of blood/blood components

Question 5

What are the different types of serious adverse reactions

Answer 5

Fatal
Life threatening
Life disabling
Life incapacitating
Or which results in, or prolongs, hospitalisation or morbidity

i.e. any event that might lead to death

Question 6

Give an example of a serious adverse reaction
(3)

Answer 6

Any event that might lead to death

e.g. you come in in the morning and see a pack left out of the fridge from the night before

This would have previously just ben dumped but not it has to be recorded as a serious adverse reaction

Question 7

Define a serious adverse event

Answer 7

Any untoward occurence associated with the collection, testing, processing, storage and distribution that might lead to death, life threatening disability or incapacitating conditions for patients or which results in or prolongs hospitalisation of morbidity

Question 8

What is the NHO

Answer 8

National Haemovigilance Office

Question 9

Write about the NHO

Answer 9

Located in the IBTS
Set up in 1999

Collects anonymised reports of transfusion associated adverse reactions and events from healthcare professionals

Question 10

What are the five main aims of the NHO

Answer 10

Receive, collate and follow up - reports from hospitals and GP’s of adverse reactions connected with transfusion of blood products and provide feedback

Advise on - follow up action deemed necessary

Report - adverse reactions to the Irish Medicines Board

Produce an annual NHO report on SAR and SAE etc

Provide on -going support to hospital based HVO or Transfusion Practitioner (TP) to medical nursing and technical staff as appropriate

Question 11

What does the NHO provide advice on?

Answer 11

Improvements to safe transfusion practice

Question 12

What does the NHO support
(2)

Answer 12

Development of clinical guidelines for hospitals in relation to the use of blood

Audit functions of hospitals in relation to transfusion practice

Question 13

What does the NHO promote

Answer 13

The development of ‘full traceability’ regarding transfusion records

Question 14

What does the NHO liase with

Answer 14

e.g. the Nation Transfusion Advisory Group (NTAG) to develop national ‘best practice’ in transfusion

Question 15

What is SHOT

Answer 15

Serious Hazards of Transfusion Initiative

Question 16

Give an example of where the NHO got involved with a hospital case

Answer 16

There was a patient reaction due to a platelet incubator getting too hot

The lab was shut down for 7 days until air conditioning could be installed

Question 17

How is the NHO involved in managing products

Answer 17

Ensures blood is only given if they are definitely needed

Preventing the need for transfusion i.e. if iron low before surgery give profalactic iron before surgery to prevent need for transfusion

Question 18

What does the EU Directive do

Answer 18

Sets standards of quality and safety for the collection, processing, storage and distribution of human blood and blood components and amending Directive

Question 19

What is the Aim of the EU Directive

Answer 19

Ensures that blood and it’s components are of comparable quality and safety throughout the transfusion chain in all member states

Setting minimum community standards

Question 20

When was the EU Directive put into Irish law

Answer 20

Transposed into Irish Law by Statutory Instrument on 8th November 2005

In effect from Nov 2008

Question 21

In your own words what does the EU Directive require labs to do

Answer 21

Report serious reactions and events (this is mandatory)

Quality and safety is of primary concern for blood establishments and hospital blood bamks

Question 22

How is the EU Directive implemented

Answer 22

ISO15189
INAB
Accreditation

Question 23

What is the definition of a blood establishment

Answer 23

Any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage and distribution when intended for transfusion

Question 24

What is the definition of a hospital blood bank

Answer 24

A hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities