HAEMOVIGILANCE. Ms. Emma O Riordan.

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1 HAEMOVIGILANCE a set of surveillance procedures covering the whole transfusion chain from the collection of blood and its components to the follow-up of its recipients, intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurence & re-occurence Ms. Emma O Riordan. A/CNM 2 Haemovigilance C.U.H. The Postgraduate Medical Education Service NCHD (Anaes.) Cork University Hospital Date: 2016

2 EU Blood Directive 98/EC/2002 The EU directive has been transposed into Irish law with full compliance with the legislation by November Organisations, including hospital, not complying with the directive could face fines or criminal charges Sets standards for quality and safety for collection, testing, processing, storage and distribution of human blood and blood components Specifies certain technical requirements for blood and blood components and for quality management systems, traceability and notification of adverse events & reactions, training personnel and Strict Document Control

3 SNBTS Blood Transfusion E-learning : All NCHD s must complete module 1 and 2 Submit a certificate of completion to Haemovigilance either by to brid.doyle@hse.ie or emma.oriordan@hse.ie or to the CUH Blood Transfusion Laboratory (Refer to Induction Pack) SNBTS better blood transfusion

4 CUH Patient Information Leaflet Informing the Patient Medical Responsibility Patient Information Leaflet Document Transfusion Record (form 15/15A) Ask the patient to read it Discuss any concerns & worries Document discussion in the Patient Health Records Refusal

5 Blood Component Prescription Documentation (Form No. 15/15A) Medical Responsibility Prescription of all Blood Components RCCs, PLTS, OCTAPLAS FIBRINOGEN, OCTAPLEX, ALBUMIN etc Complete Fully Clearly Legibly

6 May 2015 Theatre Prescriptions Audit May 2015: 5% Transfusions not prescribed, only 23% had prescribed special requirements, identity of the prescriber was documented in 89% of cases 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Name MRN Date Time Product Type Prescriber Reason forcmv-/irrad TX Rate May-15 May-14 Jun-13 Mar-12

7 Special Blood Requirements 3 SAE s ~ irradiation requirement not indicated in SAE s ~ irradiation requirement not indicated in 2015 (1 Surgical patient)

8 Sampling & Labelling the pre-transfusion specimen

9 5.5% of samples were rejected in January November Completion of the Blood Transfusion Request Medical Responsibility POSITIVE patient identification. Identity wristband Form & sample must be hand written (no addressograph stickers!) Complete form using the patient s health records: Fully! Confirm details are correct. Special Blood Requirements, Transfusion history, reason etc Sample labelled by hand immediately after taking the specimen and before leaving the bedside. Absolute minimum identifiers Patient s Full Name Patient s M.R.N. Patient s D.O.B. Your Signature, Bleep, MCRN Zero Tolerance for Samples received in CUH Blood Bank which did not meet the Minimum Labelling Requirements.

10 Wrong Blood in Tube Events Occurring in CUH 1 WBIT event detected in January : 4 WBIT Events Detected 2014: 2 WBIT Events Detected 2013: 3 WBIT Events Detected 2012: 7 WBIT Events Detected 2011: 6 WBIT Events Detected 2010: 3 WBIT Events Detected

11 BLOOD STORAGE Blood must be stored in dedicated blood fridges. There are 4 blood fridges located in CUH: - CUH Blood Bank, - General Theatre, - Cardiac Theatre - CICU. There is NO Blood Fridge located in CUMH. In an Emergency situation where more than one unit of blood is required urgently igloo boxes should be used where a fridge is not available. Blood administration to the patient must be commenced within 30 minutes of leaving Blood fridge or igloo box storage.

12 Blood Administration A standard blood administration set containing an integral filter ( microns) must be used to administer blood products. Do not add any infusion solutions or drugs to blood component under any circumstances as this may result in haemolysis, clotting or incompatibility. Blood warmer use is indicated for patients receiving massive transfusions (at or in excess of 50ml/kg/hr) or if the patient has cold agglutinins.

13 Pre-administration Checks Two people (RGN/Doctor) must undertake uninterrupted checks of: Patient Hospital identity Bracelet Patients Healthcare Records White Compatibility Form Blood Component Prescription and Transfusion Record (Form 15/15A) Blood Product Surname, First name, Date of Birth, MRN must be identical on all of the above, if there is any discrepancy do not transfuse the blood product. Contact the Blood Transfusion Laboratory.

14 CUH Notification of Suspected Transfusion Reaction (Back of Form 15/15A) Recognising, managing and investigating suspected transfusion reactions

15 CUH/CUMH Policies & Procedures (Induction Pack) Your responsibility to be familiar with and to apply the CUH/CUMH blood transfusion policies and procedures CUH/CUMH policies and procedures are only available electronically on Q-Pulse Q-Pulse available at all ward based PCs Q-Pulse accessed through the Staff Directory (Citrix) on the desktop of all ward computers

16 BLOOD TRANSFUSION REQUESTS Two Specific Types Of Order Group & Hold or Group & Screen ( ~40 Minutes) Patient Blood Group and Antibody Screen Performed Blood is NOT Ready Used for Procedures That Are Unlikely to Use Blood, Used As a Safety Measure Group & Crossmatch (~60 Minutes) Patient Blood Group and Antibody Screen Performed PLUS Units Of Blood Crossmatched For Patient Blood IS Ready Only Order When Definitely Going To Transfuse Follow C.U.H. MSBOS for theatre patients. Emergency O Rh (D) Negative units Extreme Emergencies Conserve O Neg Stocks Only Compatible with ABO Rh and Kell Blood Groups

17 ORDER ON THE BLOOD PRODUCT REQUISITON FORM: AVAILABLE IN THE CLINICAL AREA PLATELET POOLS Stocks of pooled platelets are not stored in the CUH blood transfusion lab Ordered by the Blood Bank from IBTS as required Only Order When Definitely Going To Transfuse FROZEN PLASMA (OCTAPLAS) Plasma requires between minutes to be thawed out Must be transfused within 4 hours of thawing Once thawed the plasma cannot be reused Only Order When Definitely Going To Transfuse PROTHROMBIN COMPLEX CONCENTRATE (OCTAPLEX) Primary use for reversal of over anti-coagulation with Warfarin Seek specialist Haematology Advice

18 TRANSFUSION MANAGEMENT OF MASSIVE HAEMORRHAGE Policy & Procedure : PPG-CUH-CUH-210 (Recently updated in line with the BCSH 2015 Massive Haemorrhage Guidelines). A patient may be defined as suffering a massive haemorrhage if any of the following occur: Transfusion of more than 10 units of red cells in a 24 hr period or Transfusion of >4 units in <1 hour with ongoing haemorrhage or Predicted need for > 8 units in 2 hours or An ongoing transfusion requirement in an adult of more than 150ml/min or Replacement of one blood volume within a 24hr period or Replacement of more than 50% of blood volume in 3 hrs or less (70mls/kg for adult, 90mls/kg for a child older than a neonate).

19 Communication Alert Blood Bank 22567/ On call Bleep 199 Haematology team Inform Blood Bank if Emergency O NEGs have been taken FBC, Coagulation screen & Fibrinogen Documentation Stand down Massive transfusion packs

20 Massive Transfusion Packs First Pack 4 units RBC May contain Emergency O Neg units 2 units OCTAPLAS 1 adult therapeutic dose platelets Second Pack can follow if requested 4 units RBC group specific or crossmatched 2 units OCTAPLAS 1 adult therapeutic dose platelets 2g Fibrinogen Products will be available as they become ready NOT in a single delivery. Transport organised by the clinical area. 2 x Fibrinogen available in the drug fridge in anaesthetic ROOM 3 in CUMH for massive obstetric haemorrhage EMERGENCY use only. Inform blood bank if they are used so that they will be replaced.

21 IGLOO BOX (Safe Cell Transport Box) Blood is safe for use for 6 hours when stored in an igloo box. The time the blood has left the igloo box must be documented in the form. If the blood is out of the cooler for more than 30 minutes it must be returned ASAP to the blood bank unused. If you receive a patient from another hospital with an igloo box: Send the container to the blood bank. Do not remove any blood unnecessarily from the container, it is stored at the correct temperature. If blood is immediately required, it is your responsibility to carefully check the compatibility form, nameband and MRN of referring hospital.

22 Traceability There were two further episodes of non-documented units in December % Traceability Achieved % 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%100.0% 99.9% 99.9% 99.9% 99.9% 99.9% 100% 100% 100% 100% 99.7% 99.9% 99.5% 99.0% 99.5% 99.7% 99.7% 99.7% Dark green bar represents 100% of units accounted for following investigation when subsequent written confirmation of transfusions was obtained. 98.5% 98.0% J F M A M J J A S O N D

23 Clinical Areas Where Non-Documentation has Occurred in episodes of nondocumentation of a unit in were during a massive haemorrhage. CUH ED: 1 occurance CUH GI Clinic 1 occurance CUH Radiology dept: 3 Occurances CUH Wards: 2 Occurances CUH ED CUH GI CLINIC CUH RADIOLOGY CARDIAC THEATRE CUH WARD 2A CUH WARD 3B 0.5 0

24 Think before you transfuse Is the transfusion necessary? Is the transfusion appropriate? Has the correct sample been taken at the correct time from the correct patient and with the correct label? Is the transfusion record complete? Is the transfusion documented?

25 HAEMOVIGILANCE Any Questions? Any Questions? Contact details available in Induction Pack