a set of surveillance procedures covering the whole transfusion - - PowerPoint PPT Presentation

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 Teaching @ Cork University Hospital Date: Thursday 28th January 2016

EU Blood Directive 98/EC/2002

The EU directive has been transposed into Irish law with full compliance with the legislation since November 2008. 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

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”

Why is it there?

To ensure that the same high standards are to be met throughout EU.

What is it? It’s an EU law.

Summary of the EU Blood Directives

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!

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)

SNBTS Blood Transfusion e-learning certification

“SNBTS better blood transfusion” www.learnbloodtransfusion.org.uk/ Print off Certificate and hand into Blood Bank

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

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

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….”

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

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

Blood Transfusion Prescription

Blood Transfusion Prescription

Indicate Clearly Complete Legibly

Overall Comparison of Blood Component Prescription Documentation

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Date Component Reason Patient Info Leaflet Special Requirements No.Units Prophylaxis Rate MCRN

• Prescrib. Id

Sep-15 Feb-15 Jul-14 Mar-14

Special Blood Requirements

3 SAE’s ~ irradiation requirement not indicated in 2014 2 SAE’s ~ irradiation requirement not indicated in 2015 (1 Medical, 1 Surgical patient)

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

Seasonal Variation

103 83 88 90 83 70 130 112 92 99 79 91 20 40 60 80 100 120 140 J F M A M J J A S N D

Jan – Dec 2012 15,912 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.

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 D.O.B.  Patient’s M.R.N.  Your Signature and Contact No.

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

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

Rate of mis-collected or mis-labelled samples is 1000-10,000-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

• f individual risk estimates (Dzik 2002)

2015: 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

Wrong Blood in Tube Events Occurring in CUH

1 WBIT event detected in January 2016

1 2 3 4 5 6 7 2010 2011 2012 2013 2014 2015

─ 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

 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

CUH/CUMH Policies & Procedures

Log On, select “Documents”, select “My Folders”, select “Haemovigilance”

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

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

BLOOD TRANSFUSION REQUESTS

Red cell concentrate

─ Red cells in “additive solution” – virtually no plasma ─ Leucocyte depleted ─ Stored at 2oC - 6oC ─ 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

BLOOD TRANSFUSION REQUESTS

BLOOD TRANSFUSION PRODUCTS

PLATELETS

─ Stored @ 22oC + 2oC (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

BLOOD TRANSFUSION PRODUCTS

Frozen plasma (SD Plasma - OCTAPLAS)

– Plasma frozen after separation – Stored in Blood Bank at < minus 30°C – Requires 20-30 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.

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

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

• r

 Transfusion of >4 units in <1 hour with ongoing haemorrhage

• r

 Predicted need for > 8 units in 2 hours

• r

 An ongoing transfusion requirement in an adult of more than 150ml/min

• r

 Replacement of one blood volume within a 24hr period

• r

 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).

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

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

• bstetric 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!!!

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?

HAEMOVIGILANCE

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 “…estimated up to 70 steps involved in the transfusion process….” (McClelland, ‘99)

‘…most deaths associated with blood

transfusion are the result of mistakes in identification…’ Haemovigilance is everyone’s responsibility

Any Questions?

Any Questions?