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Dr Thayani Sivasambu

Ketua Seksyen Haemovigilance

Just Do It

Pengarah

Bahagian National Surveillance & Assessment

Seksyen National Haemovigilance Coordinating Centre

• Seconvert Donor
• Seroconvert Recipient

Carta Organisasi Pusat Darah Negara

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Seksyen Assessment

Seksyen Seroconvert

• Donor Haemovigilance
• Recipient Haemovigilance

Haemovigilance (HV)

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• Haem (‘Greek’ word) : blood

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• Vigilance(‘Latin’ word) : paying particular attention to

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A set of surveillance procedures covering the transfusion chain

Introduction

• What is it ?

It is a surveillance procedure.

• What is it monitoring ?

The whole transfusion chain from the donor to the recipient

• Why?
• To collect and assess information on unexpected or undesirable effects
• To take corrective actions to prevent recurrence

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‘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 and recurrence’.

(International Haemovigliance Network [IHN], 2012)

Objective

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• To identify and to prevent occurrence or recurrence of undesirable events.
• Achieved by a systematic approach in detection of new risks and quality defects by collecting and analysing the data reported
• To improve safety, efficacy and efficiency of blood transfusion

Number of Haemovigilance Reports Received (2004 – 2017)

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• National Haemovigilance Coordinating Centre (NHCC) is currently a section under National Surveillance and Assessment Division, Pusat Darah Negara which is responsible for the National Haemovigilance Programme in Malaysia since it was initiated in 2003.

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• NHCC receives reports from blood banks from all over Malaysia in accordance to Transfusion Practice Guidelines for Clinical and Laboratory Personnel (4^th edition 2016) produced by Pusat Darah Negara

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• Haemovigilance is a surveillance programme includes identification, investigation, reporting, analysis and monitoring of adverse events, near misses and errors related to blood transfusions.

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• What to report ?

Donors : Adverse donor reaction (unintended reactions related to blood donation)

Seroconvert Donors

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Patients : Adverse transfusion event (adverse transfusion reactions, near miss , IBCT)

Seroconvert Recipients

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• Haemovigilance reporting is a tool to improve transfusion practice.

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• Number of blood recipients countrywide were 895,915 in 2016 and 889,993 in 2017 (according to Annual Report: Blood Transfusion Services 2016 and 2017 released by the Health Informatics Centre, Planning Division, Ministry of Health)

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• Since the beginning of the haemovigilance reporting programme in 2004, the number of reports received in 2017 have increased tremendously to 245.81%.

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• Number of reports received showed a modest increment of 3.26% (160) in 2017 compared to 2016 with a total number of reports of 5073 and 4913 respectively.

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• This increment implies positive response to voluntary reporting system by the Ministry of Health hospitals, private hospitals and institutions.

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What we want ?

• harmonized reporting of transfusion-related adverse reactions and events

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• Although there were 4049 Adverse Transfusion Reaction (ATR) reported in 2016 and 4245 in 2017 but only 3795 (84.23%) and 4131(89.16%) were analysed respectively due to incomplete data, unrelated to ATR and no adverse event.
• Therefore, the average rate of ATR were 0.46% in 2016 and 0.49% in 2017.

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• Approximately 80% of reports were Adverse Transfusion reaction and IBCT showed the least reported event (<1%). The commonest incidence for both years were febrile non haemolytic transfusion reaction (FNHTR) and mild allergic transfusion reaction which comprised approximately 40% each. The third common cause of ATR was unclassifiable complication of transfusion with an incidence of 5-10% for both years

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• However only 4139 and 4441 blood products were implicated for both years respectively.

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• Total number of implicated blood product was higher than total no. of ATR as---- transfused with multiple blood products.

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• For both years red cell was the most common implicated blood product in transfusion reaction (75.5%)

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• These reports will help to create more awareness and to be more vigilant in order to provide safe blood in transfusion service. The input from reports received from various hospitals in this annual report will benefit doctors to identify and manage adverse transfusion events.

• NHCC promotes hospital blood banks to notify monthly even if there were no adverse transfusion events in order to minimize underreporting. This is classified as nil adverse transfusion reaction.

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• Confidential, voluntary and non punitive

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Limitations

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• Passive data collection system by NHCC and voluntary reporting requirement by the hospital blood banks predispose to underreporting
• Outdated reporting forms that were still used by some hospitals-led to incomplete data ,hence limit ability to analyse given data
• Reporting using the summary of transfusion event /via email limit NHCC limit ability to analyse given data
• Reports were incomplete - (eg in 2016 as two hospitals submitted 56 incomplete reports had to be excluded from the analysis).

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• Quality of Reports
• Some of the cases reported did not describe details of the events / incidents, esp. near misses
• Even some cases with accompanying report, did not contain full details of the events, e.g.:
• How the error could have happened
• Why did the error happen?

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Type of Adverse Events Reported

Near Miss

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• Total number of near miss reported was 260 in 2016 and reduced to 219 in 2017

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• Hospital blood banks under Ministry of Health (MOH) contributed 83.46% (217) of NM reports in 2016 and 87.67% (192) in 2017.

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• A reduction in the number of NM reports received from Institusi Perubatan Khas / University hospitals of 43 cases in 2016 and 27 cases in 2017.

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• The average incidence of near miss in Malaysia was nearly 60 cases per 100,000 recipients for 2016 and 2017.

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• Melaka and Perlis have no reported case of near miss for both years while Pahang has 3.5 cases per 100,000 recipients in 2016 and none in 2017

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Near miss’ events are defined as any error, which if undetected, could result in the determination of a wrong blood group or transfusion of an incorrect component, but was recognized before the transfusion took place SH0T UK 2017

Incidence Of Near Miss Events Reported By Hospital Blood Banks Under Ministry Of Health

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• The incidence of near miss in relation to the number of recipients were 0.07% in 2016 and 0.06% in 2017.

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• In 2016, most cases were reported from State Hospitals (129 cases), followed by Major Specialist Hospitals (80 cases), whereas in 2017 both State Hospitals and Major Specialist Hospitals reported 95 and 70 cases respectively.

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• Data from State Health Informatics Centre, Planning Division, MOH showed top principle cause of hospitalization at these hospitals were pregnancy, childbirth and puerperium which required group screen and hold (GSH) testing in almost every case. Therefore, the probability of error to occur was higher.

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• Transfusion Medicine Specialist or haematologist was available at these hospitals to identify and report NM event.

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Type of Near Miss Event

• Type Of Near Miss Event

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• Near miss event was categorized based on the location of incident either ward, blood bank or cause of near miss cannot be determined/ inconclusive.
• NM that occurred in ward was either during the pre-transfusion sampling or blood administration.
• NM that happened during pre-transfusion were then divided to sampling error (Wrong blood in tube: WBIT), labelling error (Wrong name on tube: WNOT) and labelling and sampling error at time of blood taking.
• While near miss that happened during blood administration was divided to failure to check the blood against patient’s full identity and others.
• Near miss in blood bank was either due to technical, transcription, blood issued meant for another patient or wrong blood product supplied.
• If there were no cause concluded, this case was categorized under Cause of Near Miss Cannot Be Determined/ Inconclusive. Therefore, this will not be analyzed.
• The incidence of near miss reported was higher in ward with 85.76% (223) of cases in 2016 and 83.56% (182) cases in 2017 while blood bank showed 7.31% (19) and 10.5% (23) cases respectively.
• Near miss event under ward category was almost always due to error during pre-transfusion sampling rather than during blood administration for both years.
• In 2016, the incidence for pre-transfusion sampling was around 30% for each category but in 2017 there was an increase of 50.82% in labelling error.

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• The incidence of technical error by blood bank reduced from 52.63% in 2016 to 34.78% in 2017 while the incidence of transcription error remained around 35% in both years.

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• However, the incidence of issuing error had doubled from 10.53% in 2016 to 21.74% in 2017.

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• There were 2 cases (8.7%) reported as wrong blood product supplied in 2017.

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• There was 6.92% in 2016 and 5.94% in 2017 where the cause of near miss was unable to be determined.

Total number of reported incidents related to transfusion process were 110 cases in 2016 and increase to 186 cases in 2017.

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• Error in registration process: Sharing same ID (IC, UNHCR, Passport)
• Possible blood grouping error in other hospital/clinics
• Error in previous admission
• Error in Others (Clerical Error)
• Others (please specify)

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• 43 cases (100%) were clerical errors during transcribing the patient’s blood group from the antenatal book to the GSH form.

Causes of Other Incidents Related to Transfusion Process 2016 –2017

Incorrect Blood Component Transfused (IBCT)

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• The total number of IBCT reported has steadily increased over the years with 38 cases in 2016 and 35 cases in 2017.
• Incidence for IBCT in Malaysia were 0.01% for either year or about 1 case of IBCT per 10,000 recipients.
• Reports on IBCT were received more from state hospitals and major specialist hospitals as these hospitals were the referral centres for cases warranting for blood transfusion.
• There were 16 cases from major specialist hospitals, 12 from state hospitals in 2017 whereas in 2016 there were 17 from state hospitals and 14 were from major specialist hospitals.
• There was a reduction of 10.4% of IBCT cases noted in State Hospitals in 2017.
• University Hospitals showed an increase from 2 cases in 2016 to 3 cases in 2017.
• There were 3 cases from minor specialist hospitals in 2016 and 2 cases in 2017.
• Non-specialist hospitals reported 2 cases of IBCT in both years.

In correct blood transfusion occurs where a patient was transfused with a blood component of an incorrect blood group, or which was intended for another patient and was incompatible with the recipient, which was intended for another recipient but happened to be compatible with the recipient, or which was other than that prescribed e.g. platelets instead of red cells ( SHOT UK 2016)

Site of Error

Critical Points of Error in Ward

Sampling and/or Labelling error

• Staffs involved in the sampling and/or labeling were mainly doctors.
• There was a reduction in the number of errors done by house officers (HOs) from 7 cases in 2016 to 4 cases in 2017.
• HOs remained the highest personnel involved in sampling and/or labelling error as they were mainly involved in blood taking and labelling.
• On the other hand, medical officers contributed to 2 cases while staff nurses were the least with 1 case in each year.

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Administration error

• Correct component was collected or delivered but failure of the final identification check at the patient’s bedside led to the component being transfused to the wrong patient
• Personnel involved were mainly staff nurses with 7 cases for both years while house officers contributed to 2 cases in 2016 and 1 case in 2017.

Blood Bank Error

• Total number of IBCT were 19 cases for 2016 and 20 cases for 2017 at blood bank.

• Issuing error seemed to be the main cause of IBCT for both years.
• Blood issued meant for another patient was the commonest cause of error in issuing while the occurrence of blood issued with wrong phenotype or wrong component were the same over the two years.

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• Technical error was the second commonest cause of IBCT.
• There was an increase in the number of cases from 6 in 2016 to 10 in 2017.
• This either happened because MLT performed test on multiple sample at one time and wrongly read another patient’s results or switched samples.
• Regrouping was only done once the blood was released.
• In few instances, it was also noted MLTs were not competent enough while performing their task and never seek the assistance of other staffs when they were in a doubt.
• Staffs not adhering to standard operating procedures (SOPs)
• Increase in workload may also lead to these errors. On the other hand there were no transcription error in 2017 compared to 5 cases in 2016.

OUTCOME OF IBCT –�

• Majority of patients with IBCT had recovered with no ill effects in which were 65.79% of cases (25) in 2016 and 57.14% (20) cases in 2017.

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• There were 8 cases reported with recovery but required extended length of stay for both years with (21.05%) in 2016 and (22.86 %) in 2017.

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• There were nine deaths recorded for both years due to IBCT of which seven were not related to transfusion while two were probably related to transfusion.

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• Only 2.63% reports received in 2016 and 5.71% of reports received in 2017 did not specify the outcome of recipients.

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• This was possibly due to improvement in quality of reporting with more conscientious follow up and training done by NHCC

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Overview of The Transfusion Process

Transfusion is a complex process involving multiple departments ,staff members ,steps as well as the donors and recipients

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• Transfusion process is an interconnected process which encompass a series of steps which are linked to each other starting from recruiting donors, process of blood donation until blood transfusion.

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• Clinical transfusion process start from medical decision to transfuse blood, collection & transportation , pre transfusion testing , administering the blood and monitoring patient for any adverse events and finally managing patients if adverse events does occur.

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• Clinical transfusion process is a complex process that requires integration and coordination among multiple hospital services including laboratory medicine, nursing, anaesthesia, surgery, clerical support, and transportation.

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• Transfusion process involves many important steps that are critical for patient safety. Patient haemovigilance is a surveillance system that monitors these transfusion processes in the clinical area.

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Safe blood administration (adapted from the BCSH Guideline on Administration of Blood Components

Clinical Transfusion Process

Decision /request for blood transfusion

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Blood sampling for pre-transfusion testing

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Sample receipt/registration

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Sample testing

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Component selection

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Component labelling

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Product issued/collected

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Product administration

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Monitoring of patient

Critical steps in safe transfusion

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1) Correct and appropriate transfusion request

2) Correct donor and Patient identity

3) Correct sample collection and labelling

4) Laboratory activities

4a. Sample acceptance

4b. Sample testing

4c. Component selection

4d. Compatibility assessment

4e. Component issue

5) Patient identity + component identity

6) Blood administration

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Error in Transfusion Process

• Each element of the blood transfusion process presents inherent risk, and every aspect depends on the accurate and successful completion of the prior step
• Error may happened at any point of the process:
• Sample collection
• Lab testing
• Product collection
• Bedside transfusion
• Error(s) in any step(s) may lead to wrong blood being transfused and potential fatal haemolytic reaction

Three critical point in clinical transfusion process

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a) Decision to transfuse

b) Collection of patient sample

c) Blood administration to patient

1) Decision for blood transfusion (Requesting for blood)

• Before deciding to transfuse, consider:
• Benefits it would bring
• Risks of giving and not giving the transfusion
• Is there any alternative therapy ?
• A decision to transfuse is based on clinical judgement

Only the clinician will best know the patient’s clinical condition

• Right indication
• Right blood or blood component
• Right dose/volume

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1) Decision for blood transfusion

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• National guidelines for appropriate blood and component use should be available and used
• Doctors should be trained, competent and oriented in the local Blood Bank Laboratory

POLICIES & GUIDELINES

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2) Blood sampling for pre-transfusion testing

Process of taking and labelling must be done in one process at the bedside

Personnel involved must ensure:-

Patient shall be correctly identified before blood sampling is done

1. check the wristband
2. ask patient to state their full name

c) check the information at the wristband against the case notes

d) unconscious patient need to be identified using wristband

e) person who take and label the blood must be the same person

f) sample must be labelled clearly and accurately at bedside immediately after blood taking

g) use handwritten sample only, not preprinted

h) label must include – full name, IC, date and time of collection, and the signature of person taking the blood

i) never label two or more samples at the same time

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2) Blood sampling for pre-transfusion testing

• Follow SOP strictly
• Only one patient at any one time till completion
• No “ gotong royong”

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SAMPLE SHALL ONLY BE FROM THE INTENDED PATIENT !

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Errors in patient identification

• Patient is not asked to state their name, and these are not checked against the same details on the wristband, GXM form and the medical notes

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• Staff rely on self-identification of the patient

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• No identification wristband

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• The patient details on the wristband are not illegible

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• Staff did not check the details on the wristband

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• Bed number was used to identify the patient

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• Request forms and samples must be received together and must be checked on receipt
• Sample must be checked to ensure :
• Appropriately label
• Patient’s detail tally with form
• Any historical record available
• Request forms and samples must carry identical patient identification information
• The patient’s details should be handwritten on the sample tube. It is strongly recommended that pre-printed labels are not to be used
• Shall be a written policy for any unlabelled / inadequately labelled samples and/or incomplete request forms – Rejected
• Register correct demographic data

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3) Sample receipt / registration

3) Sample receipt / registration - Problems encountered

• Wrong registration
• Wrong demographic data entry
• Enter to incorrect patient record
• Missed information on request

4) Sample testing

• Proper and right technique when doing
• Blood Grouping
• Ab detection tests
• Crossmatching

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• NO ‘Short cut’ taken at anytime
• Techniques should be robust

4) Sample testing- Problems encountered

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• Technical error – wrong technique, suspension etc

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• Transcription error – incorrectly entered into system

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• Interpretation error – blood grouping , antibody iden, crossmatch

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• Incomplete testing (breach of SOP) - antibody identification not performed following positive antibody screen

5) Component selection

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• Selection of correct ABO type
• Selection of correct component
• Specific requirement not met
• Expiry date

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Component Selection - Problems encountered

• Selction of a wrong product
• Selctin of wrong blood group or phenotype
• Blood with special requirement not met
• Expired blood given

6) Component labelling

• Correct component labelling
• Label one component at any one time
• No distraction

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Component Labelling- Problems encountered

• Wrong labeling
• Transposed labels (for same patient)
• Transposed labels (for different patient)

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7) Products issue (Component collection)

• Make sure that what we issue out is a right component, for the right patient and is in good quality (correct patient identity and correct component)
• Check together with ward staff/staff coming to collect
• Make sure correct transportation

7) Products issue -Problems encountered

• Wrong product issued
• Wrong patient identity
• Special requirements not met
• Product not meant for the patient
• Blood incompatible to patient
• Unscreened blood product
• Expired product

8) Administration of blood product

• Safe transfusion requires a final patient identity check at the patient bedside before blood administration.

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• Should be performed by two clinical staffs

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• This is vital to ensure the right blood is given to the right patient. 

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Administration of blood products – Problems encountered

• Incorrect product storage in ward,
• Transfusion protocol not followed
• Product not administered or wrongly administered
• Re-administer blood used for another patient to patient

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The key principles that underpin every stage of the blood administration process are:

• Positive patient identification

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• Good documentation

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• Excellent communication

7 Things to check at bedside

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1. Blood product -leakage, clumps or discoloration

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• Patient identification

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• Blood product identification.

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• Blood Group. -Check on the GXM form, pack tag/label & the product

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• Check expiry date on the pack.

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• Check special orders (eg irradiation, leucocyte depletion) and administration requirements (eg volume, rate). Check blood product -

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7. Complete documentation: sign, date, time of transfusion.

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9) Monitoring blood transfusion

• Receipt, correct storage and handling of blood units
• Monitoring of patients before, during & after transfusion
• Rapid management & reporting of adverse events
• If there is a suspected reaction, stop the transfusion immediately
• When possible, instruct your patient to notify you if they experience any possible symptoms of transfusion reaction

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Right Care is Essential !!!

Way Forward

• New reporting forms –to be used by all hospitals
• Regular Training ; to recognize transfusion reaction; how & what to report- Mesyuarat Haemovigilance Kebangsaan 30-31 July 2019
• Step-up donor haemovigilance nationwide
• Resources to improve analysis, haemovigilance reports, access to these reports- BBIS V2
• Strengthen haemovigilance programme at hospital /state level (HTC)
• HKL house officer training - 2 types of training (conducted in PDN)
• Phase 1: Orientation for HOs who have just reported for duty

-half day session

• Phase 2: Safe Transfusion Workshop

Mostly from first posting and full day session

• HKL hospital CME and CME in departments –Surgery, Medical, Neurosurgery ,
• Facilitate collaboration with others- Patient Safety council

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Conclusion

• Haemovigilance reports are essential as they facilitate corrective and preventive actions to be taken to minimize the potential risks associated with safety and quality of transfusion.

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• A complete report of error in transfusion process can helps us learn from things that go wrong or that cause harm so that blood transfusion can be safer.

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• Such information is also key to introduce required changes in the applicable policies, improve standards, systems and processes, assist in the formulation of guidelines, and increase the safety and quality of the entire process from donation to blood transfusion.

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• Analysis on the reports helped to come up with recommendations to reduce such incidents.

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• There is improvement in reporting but quality of reports being sent need to be improved.

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• Although blood transfusion is meant to benefit patients, it also carries various risks

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• Staffs shall be responsible and vigilant at every step of the blood transfusion process to prevent errors.

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• Most transfusion mishaps are due to human errors

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• Shall adhere to SOP for all procedures at all times

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• Clinical and Lab staffs shall work as an integrated team

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• Quality Management basic philosophy is that all activities to be carried out with a process approach need to identify a bad process & then correct it with good process to achieve better quality results.

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• What you need to do is to analyse your existing process, identify a good process & move from bad to a good process

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• Once you adopt a good process & start getting better results – you cannot become complacent.

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• Be vigilant & make sure that the good processes are followed day in and day out consistently.

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• You are sure to get better results !!!

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Take home Message!

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Safe transfusion =

To perform the right test, on the right sample and obtain the right results ensuring that the right blood component is issued to the right patient at the right time for the right indication

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What Do We Want To Achieve In Patient Safety?

• Do no harm to patients & prevent incident

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• Deliver safe service & better quality of care

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• Prevent / minimize medico legal implications

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Correspondence:�National Haemovigilance Coordinating Centre�National Blood Centre �Jalan Tun Razak 50400�Kuala Lumpur�tel:03-2613 2708�fax:03 2698 0362�e -mail:nhcc@moh.gov.my �