HAEMOVIGILANCE. Ms. Emma O Riordan Haemovigilance, CNM2 (Acting) Ms. Bríd Doyle, MSc. FAMLS. Haemovigilance Co-ordinator, (Acting)

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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 occurrence & re-occurrence Ms. Emma O Riordan Haemovigilance, CNM2 (Acting) Ms. Bríd Doyle, MSc. FAMLS. Haemovigilance Co-ordinator, (Acting) The Postgraduate Medical Education Service Intern Cork University Hospital Date: Thursday 28 th January 2016

2 EU Blood Directive 98/EC/2002 The EU directive has been transposed into Irish law with full compliance with the legislation since 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

3 EU Blood Directive 98/EC/2002 Key articles : Article 10: Personnel personnel directly involved in collecting, testing, processing, storage and distribution of human blood and blood components shall be qualified to perform those tasks and be provided with timely, relevant and regularly updated training Article 11: Quality Systems..requires formal quality systems to be in place Article 12: Document Control requires secure document control...documentation must be stored for 30 years Article 14: Traceability - requires vein to vein traceability Article 15: Notification of SARs/SAEs..mandatory notification of serious adverse reactions and events

4 Summary of the EU Blood Directives What is it? It s an EU law. Why is it there? To ensure that the same high standards are to be met throughout EU. So if you need blood in Stockholm or Cyprus, it s collection, processing, storage and distribution is treated to the same standard as in Ireland!

5 What the CUH expects of you SNBTS Blood Transfusion e-learning certification - certificate to be presented to Blood Bank CUH Blood component prescription Patient Information Leaflet Sampling and labelling the pre-transfusion specimen Familiarisation with the CUH/CUMH blood transfusion policies and procedures Recognising, managing and investigating suspected transfusion reactions (will be covered in second presentation in February)

6 SNBTS Blood Transfusion e-learning certification SNBTS better blood transfusion Print off Certificate and hand into Blood Bank

7 Prescription of Blood Components Four stages in prescription process Medical Responsibility: Decide on appropriate use of blood and blood components Justify the prescription using risk benefit analysis Informing the patient of the decision to transfuse Documentation of the prescription

8 Prescription of Blood Components Decision to transfuse Medical Responsibility Based on clear expectation of benefit Based on best available evidence. Benefits of the transfusion must outweigh the risks for appropriate transfusion. Refer to international guidelines on best practice with regard to transfusion Medical responsibility to inform yourselves of international guidelines National Blood Users Group Guidelines and BCSH guidelines

9 Prescription of Blood Components Justify the decision to transfuse Document reason for transfusion in patient s health records e.g. Hb 7.2g/dl, shortness of breath, transfuse one unit.

10 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 s Health record Refusal

11 Blood Transfusion Prescription Medical Responsibility Complete Fully, Clearly, Legibly Date & Time of prescription Blood Component/Product Special Blood Requirements Prophylactic Drug Therapy Rate of Infusion Patient Information Leaflet Signature, MCRN, Bleep Audit Annual INAB &/or IMB Inspection

12 Blood Transfusion Prescription Indicate Clearly Complete Legibly

13 Overall Comparison of Blood Component Prescription Documentation 100% 90% 80% 70% 60% 50% 40% 30% 20% Sep-15 Feb-15 Jul-14 Mar-14 10% 0% Date Component Reason Patient Info Leaflet Special Requirements No.Units Prophylaxis Rate MCRN Prescrib. Id

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

15 Sampling & Labelling the pre-transfusion specimen Approx. 5.5 % of specimens received into the CUH blood transfusion laboratory do not meet the MINIMUM labelling requirements i.e. Patient s Full Name, DOB & MRN plus YOUR signature on Request Form and Specimen Tube

16 Seasonal Variation J F M A M J J A S 0 N D Jan Dec ,912 blood transfusion specimens received (Group and Hold and Infant Blood Groups) 1,126 were incorrectly labelled 5.5% of samples were rejected in January December 2015.

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18 Blood Transfusion Request Form Medical Responsibility Must be hand written (no addressograph stickers!) Completed using the patient s health records & confirm details on form correct Complete fully: Date, Transfusion history, Reason for request, etc NB!!! Special Blood Requirements!!! 2 SAEs(2015) ~ irradiation requirement not indicated Blood Transfusion samples NOT processed through icm Absolute minimum identifiers Patient s Full Name Patient s M.R.N. Patient s D.O.B. Your Signature and Contact No.

19 Labelling the Pre-transfusion Specimen Medical Responsibility Specimen is labelled by hand immediately after taking the specimen and before leaving the bedside Blood Transfusion samples NOT processed through icm Specimen tube must contain the following absolute minimum identifiers Patient s Full Name Patient s D.O.B. Patient s M.R.N. Signature and Bleep No. Date, time, location etc

20 The Pre-transfusion Specimen Positive Patient Identification at the bedside Medical Responsibility Bring completed Request Form to the bedside Ask patient to state their aloud their name and D.O.B. What is your name? What is your date of birth? Check details given match Request Form and patient s Hospital Identity Bracelet Check M.R.N. on Request Form matches patient s Hospital Identity Bracelet Be extra vigilant checking the identity of the unconscious / compromised patient

21 Rate of mis-collected or mis-labelled samples is ,000-fold more frequent that the risk of viral infection (Dzik et al:2003). The risk of viral infection has decreased over the years The risk of ABO-incompatible transfusion due to sample mislabeling or patient misidentification has remained consistent (Williamson et al :1999) (Contreras and de Silva:1994) (BCSH Guidelines:1999). Comparison of the magnitudes of the risks associated with blood transfusion. The vertical lines represent log orders of magnitude (e.g. 1/10, 1/100, 1/1000 etc). The horizontal blocks represent the range of individual risk estimates (Dzik 2002)

22 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

23 Sample received in Blood Bank on patient DL; noted incorrect DOB on sample. (Grouped as A Rh POS) Doctor informed. Stated he didn t take blood from patient DL at all. However, he had taken blood from patient MK. Doctor left bedside with unlabeled sample and proceeded to label at the nurses station. He got distracted and used patient notes from DL. Historical Blood Group on DL: AB Rh POS

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

25 Log On, select Documents, select My Folders, select Haemovigilance

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

27 BLOOD TRANSFUSION REQUESTS Two Specific Types Of Order : consult MSBOS 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

28 BLOOD TRANSFUSION REQUESTS Red cell concentrate Red cells in additive solution virtually no plasma Leucocyte depleted Stored at 2 o C - 6 o C Expiry date of 35 days from date of donation Out of controlled storage for a MAXIMUM of 30 minutes Must be infused within 4 hours of starting the transfusion. Emergency O Rh (D) Negative units Extreme Emergencies Conserve O Neg Stocks

29 BLOOD TRANSFUSION PRODUCTS PLATELETS 22 o C + 2 o C (room temperature) Continuous agitation (Agitator in Blood Bank) Expiry date of between 5 to 7 days from date of donation ~ 825 per unit Apheresis Platelets Transfuse over 30 mins with appropriate observations. Order from CUH Blood Bank on Blood Product Requisition Form Stocks of platelets are not stored in the CUH Blood Bank Ordered on demand by CUH Blood Bank from IBTS as required Only Order When Definitely Going To Transfuse

30 BLOOD TRANSFUSION PRODUCTS Frozen plasma (SD Plasma - OCTAPLAS) Plasma frozen after separation Stored in Blood Bank at < minus 30 C Requires minutes to be thawed out Recommended to Transfuse within 4 hours of thawing Once thawed the plasma cannot be reused Only Order When Definitely Going To Transfuse Ordered from CUH Blood Bank on Blood Product Requisition Form.

31 BLOOD TRANSFUSION PRODUCTS Prothrombin Complex Concentrate: OCTAPLEX Seek specialist haematology advice Urgent reversal of over anti-coagulation Vitamin K antagonists, e.g. warfarin Collective name for Factors II, VII, IX, X Factors synthesised in Liver in presence of Vitamin K Refer to policy on QPULSE & product insert Order from Blood Bank using Blood Product Requisition Form ~ 325 per vial

32 MASSIVE HAEMORRHAGE Policy & Procedure : PPG-CUH-CUH-210 TRANSFUSION MANAGEMENT OF MASSIVE HAEMORRHAGE 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).

33 Communication Called by Senior Clinician (Reg or Consultant) Alert Blood Bank 22537/ On-call Bleep 199 Haematology team Inform Blood Bank if Emergency O NEGs have been taken Single line of communication between Theatre & Blood Bank Samples Haematology: FBC, Coagulation Screen inc. Fibrinogen Biochemistry: Blood gases, Biochemistry profile etc Ensure transfusion sample available Documentation & Traceability Form 15/15A Blood product Requisition Form Massive Transfusion Packs Stand down

34 Massive Transfusion Packs First Pack 4 RBC Emergency O Neg or Group Specific 2 OCTAPLAS 1 unit Platelets 2g x Emergency Fibrinogen available in CUMH for massive obstetric bleed Second Pack if requested! 4 RBC Group Specific or Crossmatched 2 OCTAPLAS 1 unit Platelets 2g Fibrinogen Products will be available as they become ready rather than in a single pack Transport organised by theatre Documentation!!!

35 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?

36 HAEMOVIGILANCE estimated up to 70 steps involved in the transfusion process. (McClelland, 99) Many healthcare workers have responsibility in the transfusion chain Doctors Laboratory personnel Nursing staff Porters Medical staff only involved in a few of the steps But they are vital links in the transfusion chain

37 most deaths associated with blood transfusion are the result of mistakes in identification Haemovigilance is everyone s responsibility

38 Any Questions? Any Questions?