cell salvage policy

8/3/2019 Cell Salvage Policy

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Cardiff and Vale University Local Health Board

Provision of Intraoperative Page 1 of 33 Ref: UHB 030Cell Salvage Policy Version 1

PROVISION OF INTRAOPERATIVE CELL SALVAGE POLICY

Reference No:UHB 030 Version No: 1 Previous Trust /

LHB Ref No:N/A

Documents to readalongside this Policy

Blood Transfusion Policy.

Classification of document: Clinical

Area for Circulation: Acute Hospital Services

Author: Consultant Anaesthetists (ClinicalLead UHB/ Lead Clinician UHL/Patient Safety Manager

Executive Lead: Medical Director

Group Consulted Via/ Committee: Surgery Services Division; Childrenand Women Division; Specialist

Services Division; TransfusionCommittee

Ratified by: Quality and Safety Committee

Date Published: 2nd March 2011

VersionNumber

Date ofReview

ReviewerName

CompletedAction

ApprovedBy

DateApproved

NewReview

Date1 Q&S

Committee22/02/11 01/02/2014

DisclaimerWhen using this document please ensure that the version you are usingis the most up to date either by checking on the UHB database for anynew versions. If the review date has passed please contact the author.

OUT OF DATE POLICY DOCUMENTS MUST NOT BE RELIED ON


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Policy for the Provision of Intra-operative Cell Salvage

Page 2 of 33 Ref: UHB 030Version 1

PROVISION OF INTRA-OPERATIVE CELL SALVAGE POLICY

CONTENTS Page No.

1 Introduction 32 Policy Statement 33 Aim 44 Objectives 45 Scope 46 Roles and Responsibilities 57 Training 78 Indications and Patient Selection 89 Contraindications and Warnings 910 Patient Information 1111 Conditions for Use 11

12 Management of Massive Reinfusion 1513 Quality Assurance 1514 Adverse Event Reporting 1715 Audit 1716 Resources 1717 Equality 1818 Implementation 1819 Review 1920 Acknowledgements 1921 References and Bibliography 19Appendix

1

Audit Proforma 21

Appendix2

Intraoperative Cell Salvage competencyassessment workbook

22

Appendix3

Intraoperative Cell Salvage in Obstetrics 23

Appendix4

Cell Salvage Patient Information Leaflet 26

Appendix5

Manufacturer Guidelines 27

Appendix6

Autologous transfusion label 28

Appendix7

Fault Log 30

Appendix8

NHS Blood and Transplant Patient InformationLeaflet

31

Appendix9

Blood loss calculation 32

Appendix10

Heparin concentration 33


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1. INTRODUCTION

Whilst allogeneic (donated) blood is an essential adjunct to health care, itis a limited resource (subject to the threat of future shortages),increasingly expensive and can present a source of risk for patients, inparticular the risk of wrong blood incidents as reported by the Serious

Hazards of Transfusion (SHOT) Steering Group1.

The Welsh Health Circular (WHC), Better Blood Transfusion: AppropriateUse of Blood, recommends that in order to make transfusion safer, toprovide better information for patients relating to transfusion and to avoidthe unnecessary use of blood in clinical practice, blood transfusion mustbe an integral part of care and clinical governance responsibilities2.

The WHC further recommended that effective alternatives to allogeneicblood transfusion be explored, including the appropriate use of autologousblood transfusion techniques such as Intraoperative Cell Salvage (ICS).

ICS is used routinely in some areas of surgical practice. The techniqueinvolves aspirating blood lost within the surgical field into a collectionreservoir. Blood is mixed with an anticoagulant solution containing eitherheparin or citrate to prevent clotting. A modified aspiration line is used todeliver the anticoagulant to the tip of the suction. As blood enters thecollection reservoir it is filtered to remove large particulate debris. Thesalvaged blood is then centrifuged and washed to produce red blood cellssuspended in saline for reinfusion to the patient. The waste products(plasma, platelets, anticoagulant etc) are removed during processing and

the washed red blood cells are transferred to a reinfusion bag. When usedappropriately, by adequately trained staff, ICS is a simple, safe and cost-effective method of reducing allogeneic transfusion3-4.

2. POLICY STATEMENT

The aim of this policy is to ensure that cell salvage is used safely andappropriately in order to avoid the risks of unnecessary autologoustransfusion in our patients. Utilising appropriate alternatives to bloodtransfusion is cost-effective and complies with clinical governancerequirements.

The collection and re-infusion of autologous red blood cells provides animportant contribution to reducing the demand for allogeneic blood.However, it is only one aspect of a strategic approach to safe andappropriate transfusion practice.

This policy is based on the original generic policy as written by the UK CellSalvage Action Group5.


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3. AIM

The aim of this policy document isto provide information that will allowclinicians to:

3.1 Utilise ICS in a safe and effective manner.

3.2 Safely identify suitable patients undergoing elective and/oremergency surgical procedures where ICS could be used.

4. OBJECTIVES

The objectives of this policy are to provide a rational and practicalframework on which to maximise patient safety during ICS by:

Promoting safer transfusion as part of clinical governanceresponsibilities.

Assisting clinical staff in the identification of patients andprocedures considered suitable for ICS and outlining theindications and contraindications.

Assisting clinical staff to provide appropriate advice onoptions for treatment, particularly where patients areanxious about risks associated with donor blood or prefernot to receive for other reasons e.g. religious beliefs ofJehovahs Witnesses.

Providing clear written information about the risks andbenefits of autologous transfusions from blood salvagedintraoperatively.

Assisting clinical staff to minimise avoidable/potential risks ofautologous transfusions from blood salvagedintraoperatively.

5. SCOPE

This policy has been written to support the implementation and use ofintraoperative cell salvage in the intraoperative/surgical setting within theCardiff and Vale University Health Board (UHB). It may also be applicablewhen intraoperative cell salvage devices are used in the pre and/orpostoperative environment (e.g. Accident and Emergency, recovery, wardetc) and for devices specifically designed for Intra and Postoperative CellSalvage.

This policy does not relate to the use of unwashed postoperativeautologous wound drains.


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6. ROLES AND RESPONSIBILITIES

6.1 The UHB is responsible for:-

ensuring that there is a Clinical Lead for Cell Salvage. Theorganisations Clinical Lead for ICS is currently a ConsultantAnaesthetist.

providing a member of the theatre management team to bethe Operational Manager, responsible for ensuring overallmanagement and facilitation of the ICS service. The SeniorNurse for Theatres is currently in this role. The OperationalManager will be supported by a number of Cell Salvage Co-ordinators.

ensuring that all cell salvage operators have been trained andachieved their cell salvage competencies.

ensuring that competent personnel in sufficient numbers areavailable to provide the ICS service, including for out of hours

cases if applicable.

6.2 The Clinical Lead is responsible for:

the overall ICS programme within the UHB.

ensuring that agreed procedures and protocols are adheredto.

informing clinical staff about the benefits of the autologousprogramme.

identifying clinical situations where cell salvage can be used.

advising on the use of ICS in special circumstances.

developing a safe out of hours ICS service.

The Clinical Lead at UHW is supported by a lead Clinician atUHL.

6.3 The Operational Manager is responsible for:-

identifying members of staff who will take on the role of co-ordinating the cell salvage service.

being involved in the purchase of equipment and servicecontracts.

liaising with the Lead ICS clinician to produce and implement

local protocols and guidelines.

6.4 The Cell Salvage Co-ordinators are responsible for:-

delivering and recording of training and competencyassessment.

arranging for cell salvage to be available at the cliniciansrequest.

If the service is not available this should be reported to the leadICS Manager and Clinician

ensuring audit is complete

regular Quality Control of machines

These roles are carried out as extended roles by named theatre staff.


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Guidance on prescribing will be attached to each of themachines.

6.8.5 bedside pre-transfusion checks and patient observations shouldbe performed and recorded during autologous blood reinfusionin the same way as for the transfusion of allogeneic blood.

Refer to the Blood Transfusion Policy. The minimumobservations required are pre-transfusion, 15 minutes into thetransfusion and on completion of the transfusion. Additionalobservations are at the discretion of the clinical staff based onan individual patient assessment.

6.8.6 adverse incidents should be documented in the patientsclinical records and reported as in section 13.

7. TRAINING

7.1 Individual staff must receive training in the indications,contraindications and technical differences specific to theirspeciality/specialities. If a member of staff moves from onespeciality to another, it is essential that training needs areidentified and addressed prior to the staff member using ICS intheir new clinical environment.

7.2 Theoretical and practical training must be undertaken and staffmust be competency assessed before they set up or operateICS equipment without supervision.

7.3 Staff carrying out ICS for Jehovahs Witness patients musthave received training and have been competency assessed inpreparing the equipment and blood for reinfusion in accordancewith the patients religious beliefs prior to carrying out theprocedure.

7.4 An ICS Competency Assessment Workbook is availablevia the BetterBlood Transfusion Toolkit atwww.transfusionguidelines.org.uk (see also Appendix II). Allmembers of staff carrying out ICS will hold this workbook and

once assessed as competent will keep an ongoing log (as inthe ICS Competency Assessment Workbook) of all the ICSprocedures they carry out.

7.5 Update training is recommended under the followingcircumstances:

7.5.1 any reasonable length of time without practical use of the ICSdevice.

7.5.2 a learning need is identified by an individual member of staff or

supervisor.


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7.5.3 changes in the product from the manufacturer or a change inthe product due to the organisation trialling/purchasing newproducts.

7.5.4 changes to national and/or local guidelines relating to anyaspect of autologous transfusion (which could include changes

to the Blood Transfusion Policy).

7.6 To ensure that trained personnel are available to operate thecell saver, for elective cases the Consultant Surgeon must giveat least two weeks notice to the Clinical Lead inanaesthesia.

7.7 Refer to section 6.4 regarding Individual Responsibilities.

8. INDICATIONS AND PATIENT SELECTION

8.1 ICS systems may be used in elective and/or emergencysurgical procedures where the surgical field is not contaminatedby faecal or infective matter and where no othercontraindications exist (see section 9).

8.2 Patient selection for ICS is at the discretion of the surgeon andanaesthetist responsible for the patient.

8.3 Providing that none of the contraindications listed in section 9exist, patients to be considered for ICS include:

8.3.1 adult and paediatric patients undergoing elective or emergencysurgical procedures where the anticipated blood loss is greaterthan 20% of the patients estimated blood volume7

8.3.2 cases fitting the criteria that are undertaken locally regularlyinclude:

Cardiac SurgeryScoliosis SurgeryRevision Hip Replacements

Major Gynaecological SurgeryAbdominal Aortic AneurysmCystectomyNephrectomyLiver ResectionPancreatic TransplantationCaesarean Sections at high risk of bleeding greater than 20%total blood volumePostpartum HaemorrhageMeningiomaMajor Trauma where blood loss likely to be greater than 20%

total blood volume


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Any procedure where blood loss is higher than expected andlikely to exceed 20% total blood volume

8.3.3 adult and paediatric patients undergoing elective oremergency surgical procedures who have risk factorsfor bleeding or low preoperative Haemoglobin levels.

8.3.4 patients who have rare blood groups or multiple antibodies forwhom it may be difficult to obtain allogeneic blood.

8.3.5 patients who, for moral, religious or other reasons, are unwillingto receive allogeneic blood and have given their consent toreceiving autologous blood collected using ICS (all suchdecisions should be documented). Reference should be madeto the patients Advanced Medical Decision where one exists.

8.3.6 if the surgical procedure to be carried out for patients above isassociated with any of the contraindications as listed in section9, the potential risks and hazards should be discussed with thepatient and their agreement to undergo ICS documented.

9. CONTRAINDICATIONS AND WARNINGS

The risk benefit ratio of ICS should be assessed for each individual patientby the surgeon and anaesthetist responsible for the patients care.

Contraindications

ICS should not be used in the following situations:

Bowel contents in the surgical field

Heparin induced thrombocytopenia or Antithrombin lllDeficiency when heparin is the anticoagulant of choice (acitrate containing anticoagulant solution may be usedinstead) (See Appendix 10)

Warnings

ICS should be temporarily discontinued when substances not licensed

for Intravenous (IV) use are used within the surgical field and couldpotentially be aspirated into the collection reservoir. The standardtheatre suction must be used to aspirate the surgical field and thewound should be irrigated with copious 0.9% IV Sodium Chloridebefore resuming ICS.

Examples of non-IV materials that should not be aspirated into theICS system include:

Antibiotics not licensed for IV use

Iodine

Topical Clotting Agents

Orthopaedic cement or debris


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The use of ICS in the presence of infection may result in bacterialcontamination of the salvaged blood. The aspiration of blood from aninfected site should be avoided and antibiotics should be given asappropriate.

Gastric/pancreatic secretions should not be aspirated into thesystem as they may cause enzymatic haemolysis and are not reliablyremoved by the washing procedure.

Pleural effusions should not be aspirated and should be drained priorto cell salvage. However, blood which subsequently accumulates in thepleural space may be aspirated.

There are concerns relating to the use of ICS in patients with sicklecell disease. The use of ICS in patients with abnormal red cell

disorders should be made on a clinical, individual patient basis.

Amniotic fluid should not be aspirated into the system due totheoretical concerns related to Amniotic Fluid Embolism. See AppendixIII for obstetric ICS usage.

The use of ICS in patients undergoing surgery for malignantdisease is not recommended by the manufacturers of ICS devices.This is due to concern about the possibility of malignant cells beingreinfused and giving rise to metastases. However, there are now anumber of reports in the literature of the use of ICS in cancer surgery

without obviously leading to early metastasis8-10and some hospitalsnow use ICS routinely during surgery for malignant disease. Aspirationof blood from around the tumour site should be avoided to minimisecontamination of salvaged blood with malignant cells and the salvagedblood should be reinfused through a leucocyte reduction filter tominimise the reinfusion of any malignant cells which may have beenaspirated into the collection reservoir. The decision to use ICS in thepresence of malignant disease should be made by the surgeon andanaesthetist in consultation with the patient and duly documented inthe medical records.

As there is no evidence to support the use of cell salvage in paediatricmalignancy surgery, the local paediatric oncologists have advisedagainst its use. In cases where it is felt that benefit may outweigh therisk, obtain the agreement of the paediatric oncologists prior toproceeding.

Cautions

The use of Hartmanns Solution will inhibit the action of citrate basedanticoagulants (e.g. ACD) if used as an irrigant or wash solution.

Air will be present in the primary reinfusion bag when it is stillconnected to the cell saver or when it has been disconnected but air


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has not been evacuated. Where possible, all air should be evacuatedfrom the primary reinfusion bag prior to reinfusion. Manufacturersadvise NOT to use a pressure cuff as there is a risk of air embolus andsome devices may also detect a back pressure if the reinfusion line isopen.

Manual mode It is recommended that ICS devices are not run inmanual mode as this may lead to reduced quality, insufficient washingof the final red blood cell product and the possible reinfusion ofpotentially harmful contaminants e.g. heparin. Machines should be runin automatic mode and manual mode should only be used when thebenefits of doing so outweigh the risks e.g. emergency situations wherethe need to reinfuse the red cells quickly outweighs the risksassociated with running the machine in manual mode.

10. PATIENT INFORMATION

Patients considered likely to have ICS during planned surgery shouldreceive information about ICS before their operation. The process shouldbe discussed with the patient pre-operatively whenever possible. Writteninformation may be useful for example the Patient Information LeafletCell Salvage(Appendix 5 I).

In the absence of an Advanced Directive, which would be followed, forpatients undergoing emergency surgery, the use of ICS is at the discretionof the surgeon and anaesthetist responsible for the patients care when itcannot be discussed with the patient prior to surgery.

11. CONDITIONS FOR USING ICS

11.1 Use of the ICS Equipment

The ICS system should be used in accordance with themanufacturers guidelines (Appendix 5).

All procedures should be carried out in accordance with thisand other relevant policy/procedural documents includinginfection control, management of sharps, decontaminationand blood transfusion.

The ICS system should be routinely run in automatic mode(see Cautions - Section 9)

Contraindications should be considered as identified inSection 9.

All staff who set up or operate ICS systems should receivetheoretical and practical training (see section 6) and shouldhave completed the ICS Competency Assessment Workbook(Appendix 2).


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Clean/non-touch/aseptic technique should be used asappropriate, to reduce the risk of infection.

11.2 Anticoagulant

The type of anticoagulant and dose used should bedocumented on the cell salvage record and anaesthetic

chart for each case (Appendix 1and Appendix 10).

Anticoagulant prepared by the operator (e.g. heparin saline)MUST be labelled clearly to avoid error.

11.3 Wash Solution

0.9% IV Grade Saline should be used as the washsolution.

The minimum wash volume, as outlined in the

manufacturers guidelines (Appendix 5) for thesize of the centrifuge bowl in use and the type of surgicalprocedure, should be used in all but the most urgentsituations.

11.4 Labelling

All salvaged blood MUSTbe labelled.

Labels should be handwritten. Pre-printed addressographlabels should not be used.

Labelling information should include:o full nameo date of birtho hospital numbero collection start date and timeo expiry date and timeo The statement Untested Blood For Autologous Use

Only11

To avoid errors in patient identification, an autologoustransfusion label such as that in appendix 6 should becompleted at the patients side, when the patient has arrivedin theatre i.e. the reinfusion bag should not be pre-labelledprior to the patients arrival in theatre or labelled after thepatient has left theatre. The patient details should betaken from their identification band and not from any clinicalrecords or charts that may be present in the operatingtheatre. All fields on the label should be completed infull.

If the system has been set up as a collect only system

(collection reservoir and aspiration and anticoagulant lineonly), the collection reservoir should be labelled in


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accordance with the above instructions for labelling areinfusion bag. If a processing set is subsequentlyloaded into the machine, the autologous label on thecollection reservoir should be transferred onto thereinfusion bag immediately or a new label completed (asabove).

11.5 Re-infusion

11.5.1 Prescribing Responsibilities: Salvaged blood reinfusion shouldbe prescribed by the responsible clinician on the bloodtransfusion documentation record.

ICS may be set up as a closed-circuit system. Blood isaspirated from the surgical field, processed andtransferred to a reinfusion bag. The reinfusion bag issimultaneously connected to the patients IV cannula via anappropriate filter (see below). The person administering thereinfusion adjusts the rate at which the red cells arereinfused using a clamp on the administration set and byadjusting the height of the reinfusion bag. A pressure cuffshould not be applied to increase the flow rate because ofthe risk of air embolism. The same reinfusion bag may filland empty many times during an operation.

Alternatively, ICS may be set up without simultaneousconnection of the reinfusion bag to the patient (as above). In

this case, the reinfusion bag is disconnected from the ICSdevice when it is full or at the end of the surgical procedureand is subsequently connected and reinfused to thepatient as in the closed-circuit system.

A filter, appropriate to the type of surgery, shouldbe used forreinfusion. In most cases this will be a 200 micron filter foundin a standard blood administration set. In certaincircumstances e.g. obstetrics and malignancy, a leukocytedepletion filter may be indicated. A 40 micronmicroaggregate filter or a 40 micron lipid depleting filter is

suggested for orthopaedic surgery where there is a risk ofcontamination or fat embolism respectively.

The reinfusion bag should be kept beside the patient at alltimes.

The reinfusion bag should not be placed into a refrigerator.

Reinfusion of the salvaged blood should follow standardblood transfusion practice as described in the BloodTransfusion Policy. The responsible clinician should


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prescribe salvaged blood for reinfusion in the samemanner as for allogeneic blood.

The patient details on the reinfusion bag mustbe carefullychecked against the details on the identification bandattached to the patient before connecting the reinfusion bag

to the patient.

The reinfusion of salvaged blood should be documentedappropriately on the blood transfusion documentation record.The autologous transfusion label, as in Appendix 6, containsa peel out section which should be completed at the time ofreinfusion and can be used for this purpose.

11.6 Expiry

The collection, processing and reinfusion of salvaged blood

should be completed within the timeframes as recommendedby the manufacturer. This should be in accordance withguidance from the American Association of Blood Banks(AABB)11 and the Blood Transfusion Policy.

The AABB Guidelines state the reinfusion times for cell salvagedblood as follows:

Intraoperative Cell Salvage: 4 hours from the completion ofprocessing.

Postoperative Cell Salvage: 6 hours from the start ofcollection(applicable when Intra-operative Cell Salvage

devices are used to salvage blood postoperatively).

Any blood that has not been transfused within the timeframe specified inthe guidelines must be disposed of in accordance with local policy fordealing with liquid biohazardous waste. (See Disposal below).

11.7 Documentation The collection and reinfusion of salvaged blood should be

accurately documented on an appropriate form such as thatin Appendix 1.

The use of a generic autologous transfusion label isrecommended (Appendix 6) - the peel out section of the labelis completed and attached to the patients clinical recordupon reinfusion of the salvaged blood.

Adverse incidents and serious Adverse Events should bedocumented/ reported (see Section 13).

Bedside pre-transfusion checks and patients observationsshould be performed and recorded during autologous blood

reinfusion in the same way as transfusion of allogeneic blood- in accordance with the Blood Transfusion Policy. Additional


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observations are at the discretion of the clinical staff based onan individual patient assessment.

The organisation should ensure that adequate records areretained in all cases where ICS is used.

11.8 Disposal of used ICS equipment Following use, all ICS disposable equipment should be

disposed of in accordance with local requirements. The UHBWaste Management Department requires cell salvageassociated waste to be disposed of in containers appropriatefor incineration.

11.9 Cleaning and Disinfection of ICS Machines Following use, the cell salvage machine should be cleaned in

accordance with the manufacturers guidance and theDecontamination Policy including procedures for cleaningequipment following high risk cases.

Following contamination of the equipment internally, theequipment should be removed from use, identified as apotential biohazard and referred to the manufacturer.

11.10 Maintenance of Equipment All ICS equipment should be serviced regularly in

accordance with the manufacturers recommendations. Amaintenance record and fault log (Appendix 7) should be

kept for each machine.

12. THE MANAGEMENT OF MASSIVE REINFUSION

As with the transfusion of large volumes of allogeneic red cells, the returnof large volumes of salvaged red blood cells will coincide with the depletionof platelets and clotting factors associated with massive blood loss.

In the event of a massive reinfusion of salvaged red blood cells, it is vital toconsider the need for additional appropriate transfusion support e.g.platelets, fresh frozen plasma and cryoprecipitate.

Staff should be alert to a large blood loss into the collection reservoir andreport this to the surgeon and/or anaesthetist.

13. QUALITY ASSURANCE

It is necessary to maintain a comprehensive quality assurance system toensure the provision of a safe, high quality ICS service.

13.1 PersonnelThe UHB has identified a single individual responsible for

ensuring that a safe and effective ICS service is provided. Theorganisations Clinical Lead for ICS is currently a Consultant


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Anaesthetist. The Lead is responsible for ensuring that qualityassurance systems are fully implemented.

The organisation will ensure that competent personnel insufficient numbers are available to provide the ICS service,including for out of hours cases if applicable. Personnel involved

in ICS will have undergone appropriate training (see section 6)and competency assessment (Appendix 2). Training Recordswill be maintained for all staff involved in the ICS process and itis highly recommended that individuals maintain a case log of allprocedures in their own portfolios.

13.2 EquipmentAll ICS equipment must be appropriately maintained.Maintenance should include both an operator maintenanceprogramme and regular manufacturer maintenance visits.Operator maintenance programmes should include theimplementation of a documented cleaning and minor checkingsystem and the use of a machine specific fault log (Appendix 7).Manufacturer maintenance visits must be carried out by anauthorized service engineer who will perform a series ofdocumented maintenance controls and fine tune the device formaximum performance.

13.3 Product QualityA Quality Control procedure will be performed on eachmachine every 2 months at both UHL and UHW sites. The QC

log is to be checked by the operator prior to each case, andsamples taken if the last QC was performed more than twomonths ago. This involves taking 2 samples from salvaged bloodprior to return to patient.

A full blood count is requested on 1 sample to assessHaematocrit. An acceptable level to be obtained is betweenabove 45%.

An anti factor Xa assay is requested on the 2nd sample toassess heparin contamination. A result of < 0.05U/ml is reported

as the lower limit of detection of the anti factor Xa assay.

The QC results will be returned to the clinical lead who willrecord this data in the QC logbook for each machine.

If results are outside the acceptable range further managementwill be discussed with haematology, and the manufacturers.


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14. ADVERSE EVENT REPORTING

Technical problems with ICS should be reported to themanufacturer. It is advisable to discuss any actionsuggested by the manufacturer with Clinical Engineering.

Serious Adverse Events must be reported to the ClinicalLead for ICS and the Transfusion Practitioner. Anyadverse events relating to the ICS device must bereported in accordance with the UHB Incident Reportingand Investigation Procedure 12. Additionally, whereappropriate reporting to the relevant external bodiesshould be undertaken e.g. Serious Hazards ofTransfusion (SHOT), Medicine and Healthcare productsRegulatory Agency (MHRA), especially if the incident hasled to or, were it to occur again, could lead to death, life-threatening illness or injury.

Other minor safety or quality incidents should also bereported as these can help demonstrate trends orhighlight inadequate manufacturing or supply systems, orinadequate instructions and/or training13.

Adverse events should also be documented in thepatients clinical records.

Examples of Adverse Events include:

Severe reaction on reinfusion of salvaged blood

Non-labelling / incorrect labelling of salvaged blood

Equipment malfunction

Communication failure leading to inappropriate reinfusionof the salvaged blood e.g. contamination occurred withinthe surgical field and this was not communicated to theoperator/anaesthetist.

15. AUDIT

Appropriate audit activity will be co-ordinated via the Cell Salvage WorkingGroup. Refer also to Appendix 1.

16. RESOURCES

The UHB will ensure adequate resources for the formal, documentedtraining of all staff who set up or operate the equipment and for the regularmaintenance and prompt repair of all ICS equipment.


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Welsh Blood Service (WBS) provides a substantial amount of funding forIntraoperative and Postoperative Cell Salvage, however, funding is cappedand the UHB makes up the shortfall. In order to reduce costs, the reservoirfor collection only is set up in the first instance. Processing is only to occurif adequate volumes are obtained and a decision is made to process andreinfuse collected blood to the patient.

Evidence of cell salvage activity and consumable use must be providedto the WBS to enable reimbursement to the organisation.

17. EQUALITY

The UHB is committed to ensuring that, as far as is reasonably practicable,the way it provides services to the public and the way it treat its staffreflects their individual needs and does not discriminate against individualsor groups. The UHB has undertaken an Equality Impact Assessment andreceived feedback on this policy and the way it operates. The UHBwanted to know of any possible or actual impact that this policy may haveon any groups in respect of gender (including maternity and pregnancy aswell as marriage or civil partnership issues), race, disability, sexualorientation, Welsh language, religion or belief, transgender, age or otherprotected characteristics. The assessment found that there was a low tomedium impact to the equality groups mentioned. Where appropriate theUHB will make plans for the necessary actions required to minimise anystated impact to ensure that it meets its responsibilities under theequalities and human rights legislation.

18. IMPLEMENTATION

This policy document will be circulated to all relevant personnel andimplemented in all areas which may be involved in ICS. This will include:-

Consultant Lead for TransfusionClinical Lead for ICSDirectorate Manager for TheatreTransfusion PractitionerJehovahs Witness Hospital Liaison CommitteeSenior Nurse for Theatres

Relevant surgical specialtiesObstetrics and Gynaecology

It will also be available via the UHB Intranet. Members of the public will beable to access it via the website of the UHB with hard copies beingprovided on request.

Guidance on and queries relating to the policy should be addressed to theorganisations Clinical Lead for ICS.


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19. REVIEW

The policy document will be reviewed at timely intervals. This will be whennew information becomes available that needs to be incorporated to thedocument, or as a maximum, every 3 years.

20. ACKNOWLEDGEMENTS

Maria Roberts, Patient Safety Manager, formerTransfusion Practitioner, Welsh Blood Service / Cardiffand Vale NHS Trust for her original Postoperative CellSalvage procedure document on which this policy hasbeen based14

The members of the UK Cell Salvage Action Group

Royal Brompton & Harefield NHS Trust Policy for theprovision of Perioperative Red Cell Salvage15

St Marys NHS Trust Obstetric Intraoperative Cell SalvageGuidelines16.

21. REFERENCES

1. Serious Hazards of Transfusion (SHOT) Report 2005.http://www.shotuk.org/SHOT%20report%202005.pdf

2. Better Blood Transfusion: The Appropriate Use of Blood(2002) HSC 2002/009

3. Murphy GJ, Rogers CS, Lansdowne WB, Channon I,Alwair H, Cohen A, Caputo M and Angelini GD (2005)Safety, efficacy, and cost of intraoperative cell salvageand autotransfusion after off-pump coronary arterybypass surgery: a randomized trial. J Thorac CardiovascSurg; 130(1); 20-8

4. James V (2004) A National Blood Conservation Strategyfor the NBTC and NBShttp://www.dh.gov.uk/prod_consum_dh/idcplg?IdcService=GET_FILE&dID=26734&Rendition=Web

5. Policy for the provision of Intraoperative Cell Salvage.http://www.transfusionguidelines.org.uk/docs/misc/bbt-03_icsag-policy-v11.doc

6. British Committee for Standards in Haematology BloodTransfusion Task Force (1999). The administration of

blood and blood components and the management oftransfused patients. Transfusion Medicine;9; 227-238.


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7. British Committee for Standards in Haematology BloodTransfusion Task Force (1997) Guidelines for AutologousTransfusion II. Perioperative Haemodilution and CellSalvage. British Journal for Anaesthesia;78; 768-771.

8. Gray CL, Amling CL, Polston GR, Powell CR and KaneCJ (2001) Intraoperative cell salvage in radical retropubicprostatectomy. Urology; 58(5); 740-5.

9. Nieder AM, Carmack AJ, Sved PD, Kimm SS, ManoharanM and Soloway MS (2005) Intraoperative cell salvageduring radical prostatectomy is not associated withgreater biochemical recurrence rate. Urology; 65(4); 730-4.

10. Nieder AM, Manoharan M, Yang Y and Soloway MS(2007) Intraoperative Cell Salvage during radicalcystectomy does not affect long term survival. Urology;69(5); 881-4.

11. American Association of Blood Banks (AABB) (2005)Standards for Perioperative Autologous Blood Collectionand Administration (2nd Edition)

12. Cardiff and Vale NHS Trust Incident Reporting andInvestigation Procedure, May 2007

13. http://nww.cardiffandvale.wales.nhs.uk/pls/portal/docs/PAGE/POLICY_PAGEGROUP/LIBRARY/RISK%20MANAGEMENT%20POLICY.PDFMedicines and Healthcareproducts Regulatory Authority (MHRA) (2007) DeviceBulletin: Reporting adverse incidents and disseminatingmedical device alerts.http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2025834&RevisionSelectionMethod=LatestReleased

14. Roberts, M.M. (2006) Procedure for Post-operativeAutologous Blood Transfusion Drainage Systems in Adultand Paediatric Patients. Cardiff and Vale NHS Trust.

15. Kelleher, A.A. (2004) Policy for the Provision ofPerioperative Red Cell Salvage. Royal BromptonandHarefield NHS Trust.

16. Obstetric Intra-operative Cell Salvage Guidelines (Draft1). St Marys NHS Trust2006.


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Appendix I

Audit Proforma

The audit proforma is kept with in each theatre block within the UHB (UHW

Main Theatres, UHW Cardiac Theatres, UHW Delivery Suite Theatres,Llandough Main Theatres)


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APPENDIX 2

Intra-operative Cell Salvage Competency Assessment

WorkbookThe Intraoperative Cell Salvage Competency Assessment Workbook is availablethrough the Better Blood Transfusion Toolkit website at:

www.transfusionguidelines.org.uk


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APPENDIX 3

Intraoperative Cell Salvage in Obstetrics

ICS is being increasingly used in the UK in obstetrics for women at risk frompost-partum haemorrhage during caesarean sectioni. In the year 2005-2006,

38% of UK maternity units used ICS, and 28% included the use of ICS in theirMassive Obstetric Haemorrhage (MOH) protocol. Early, theoretical concernsover amniotic fluid embolism have not been borne out in clinical practice and80% of maternity units identified the barrier to more use as lack of trainingrather than safety concerns

The use of ICS in obstetrics has been endorsed by:

The Confidential Enquiry into Maternal and Child Healthii

Joint Association of Anaesthetists of Great Britain andIreland/Obstetric Anaesthetists Association Guidelinesiii

National Institute Clinical Excellenceiv

It is strongly recommended that any health care professional involved withobstetric ICS be familiar with all these guidelines.

Patient Selection and PreparationWherever possible, the advantages and risks of ICS and allogeneic bloodtransfusion should be discussed with the patient prior to undergoing an

obstetric surgical procedure. In a pre-planned case this can be during thepregnancy. It is recommended that patients receive the NHS Blood andTransplant information leaflet entitled Will I need a blood transfusion?(Appendix VIII) which contains an Alternatives to blood transfusion sectionand the Intraoperative Cell Salvage Patient Information Leaflet (Appendix IV).

The NICE guidance Intraoperative blood cell salvage in obstetricsrecommends that whenever possible, the woman understands what isinvolved and the theoretical risks, and agrees (consents) to have theprocedureiv. When obtaining formal consent for a caesarean section, theobstetrician or anaesthetist should discuss the advantages and risks of ICS

with the patient and document clearly the agreement of the patient toundertake the procedure. Such detailed consent may not be practicable in anemergency, as for allogeneic transfusion.

Indications for ICSPatient selection for ICS is at the discretion of the obstetrician andanaesthetist caring for the patient. The type of obstetric cases that should beconsidered for selection include:

Emergency situations:

Ruptured ectopic pregnancy


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Post-partum haemorrhage

Elective situations:

Patients with an anticipated blood loss of >1000mls eg placentaaccreta, large uterine fibroids, and other predictable causes of MOH

Other situations: Patients who for religious or other reasons refuse allogeneic blood and

have consented to the use of ICS in elective or emergency bleedingsituations or in significant anaemia.

Additional measures necessary in obstetric ICS:

Amniotic fluid and use of Leukocyte Depletion FilterAmniotic fluid should ideally not be aspirated into the ICS collection reservoir,but should be removed by separate suction prior to starting cell salvage. This

recommendation will reduce the initial contamination , but it should be notedthat the in vitroevidence is that the ICS process can effectively removeplasma phase elements of amniotic fluid whatever the initial loadv. Therefore,in life-threatening haemorrhage, a clinical decision to use ICS from the start ofthe procedure could be carefully considered.

After processing, a Pall RS filter (LeucoGuard RS Leukocyte ReductionFilter, Pall Biomedical Products Co.,East Hills, NY) should be used to reinfuseICS blood. This is the only filter proved to effectively eliminate residualparticulate elements of amniotic fluidvi. It should be remembered that prior to2000 this filter was not available, over 250 obstetric cases worldwide safely

received ICS blood without a problem prior to the availability of this filter.Therefore, in life-threatening haemorrhage a clinical decision to reinfuse ICSblood without this filter could be carefully considered.

8 Rh immunisation and Kleihauer testingIn any pregnancy involving an Rh negative mother and an Rh positive fetusthere is a danger of Rh immunisation if the maternal circulation is exposed tofetal red cells. Antibodies against the fetal red cells can cause haemolyticdisease of the newborn in subsequent pregnancies if untreated. Consequentlyall Rh negative mothers of Rh positive babies will have a Kleihauer performedin the immediate post partum period.

Kleihauer testing is required to establish the amount of fetal red cell exposureand ensures that the mother receives an appropriate dose of Anti-Dimmunoglobulin (usually 125 iu/ml of fetal blood). Depending on the results ofthe Kleihauer, a minimum of 500iu Anti-D will be offered in the post partumperiod to Rh negative mothers with Rh positive babies.

The same protocol should be followed for Rh negative mothers who haveundergone reinfusion of ICS blood. The presence of fetal red cells in the ICSblood is likely because the ICS device cannot distinguish fetal from maternalred cells. Depending on the test results it may be that higher doses of Anti-Dwill need to be administered.


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The sample for Kleihauer testing should be taken after the reinfusion ofICS blood and administration of Anti-D should occur within 48- 72 hrs ofdelivery.

References

i. OAA Survey of UK Maternity Units June 2007

ii. Confidential Enquiry into Maternal and Child(CEMACH) (2000-2002).Why Mothers Die - Report on confidential enquiries into maternal deathsin the United Kingdom. Chapter 4 (Haemorrhage) p91-92 Prof MarionHall

iii. OAA/AAGBI (2005) Guidelines for Obstetric Anaesthetic Servicesrevised Edition; p25

iv. National Institute For Health & Clinical Excellence (NICE) (2005) Intra-operative Blood Cell Salvage in Obstetrics Guidancehttp://guidance.nice.org.uk/IPG144/guidance/pdf/English/download.dspx

v. Catling S.J., Williams S. and Fielding A.M. (1999) Cell salvage inobstetrics: an evaluation of the ability of cell salvage combined withleucocyte depletion filtration to remove amniotic fluid from operativeblood loss at caesarean section. Int J Obs Anesth; 8;79-84

vi. Waters JH. Biscotti C. Potter PS. Phillipson E. (2000) Amniotic fluid

removal during cell salvage in the cesarean section patient.Anaesthesiology; 92;1531-1536.


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APPENDIX 4Cell Salvage Patient Information Leaflet

The Cell Salvage patient information leaflet can be downloaded from:http://www.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=28445


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APPENDIX 5

Manufacturers Guidelines

These are held centrally by the Clinical Lead for ICS (Sorin + Haemoneticsdevices).


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APPENDIX 6

Autologous Transfusion Label

Version currently in use locally at time of policy development


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Reverse of Autologous Transfusion Label


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APPENDIX 7

Fault Log


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APPENDIX 8

NHS Blood and transplant information leaflet entitled Will I need ablood transfusion

An order form for the NHS Blood and Transplant information leaflet Will I

need a blood transfusion can be downloaded at:

http://blood.co.uk/hospitals/library/pdf/PIL_Order_form_v22.pdf

Alternatively the leaflet can be downloaded at:

http://blood.co.uk/hospitals/library/pdf/INF_PCS_HL_001_05_will_i_need_leaflet_ENGLISH.pdf

The leaflet is available in a number of other languages (Welsh, Albanian,Arabic, Bengali, Chinese, Croatian, Farsi, French, Greek, Gujarati, Pashto,Polish, Punjabi, Serbian, Somali, Sorani, Turkish, Urdu, Vietnamese) at:

http://hospital.blood.co.uk/library/patient_information_leaflets/leaflets/index.asp


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APPENDIX 9

Blood loss calculation

At the end of the procedure, when all of the blood from the collection reservoir

has been processed, an estimate of the volume of blood the patient has lostduring procedure can be made using a simple calculation.

The information required is:

Fluid in volume (Machine read out) Total volume of fluid processed bymachine, includes: blood aspirated from surgical field, anticoagulant andirrigation from surgical field.

Irrigation fluid - Volume of sterile irrigation fluid used within surgical field andaspirated into the ICS collection reservoir.

Anticoagulant used- An estimate of volume used

Swab wash Volume of IV normal Saline (0.9% Nacl) or equivalent used towash swabs

Theatre Suction

Wet-dry weight of swabs- compensates for blood and saline swab washretained on swabs and allows them to be weighed outside of sterile field after

washing.

Blood Loss calculation

Blood Loss = Fluid in volume plus theatre suction plus ( wet-dry weight of swabs) irrigation fluid anticoagulant used swab wash


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APPENDIX 10

Heparin Concentration

Heparin Saline

In usual circumstances, 30,000 iu of Heparin is added to 1,000ml of IV normalsaline (0.9% NaCl) and labelled clearly with an appropriate drugs addedlabel.

Some manufacturers recommend that 60,000 units of Heparin should beadded to 1 litre of intravenous (IV) normal saline (0.9% NaCl) forneurosurgical procedures. This should be confirmed with the manufacturer.

The Heparin Saline anticoagulant concentration should be checked by theLead Anaesthetist at the start of the procedure and documented on the WelshBlood Service audit form. Under no circumstances should the heparin usedfor preparation of anticoagulant for cell salvage purposes be prescribed on aninpatient drug chart. This is to reduce the risk of inappropriate administrationof heparin saline outside of the theatre environment.

A pre prepared citrate based anticoagulant should be used for patients withantithrombin III deficiency.