CLINICAL GUIDELINE FOR INTRAOPERATIVE CELL SALVAGE 1. Aim/Purpose of this Guideline

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1 CLINICAL GUIDELINE FOR INTRAOPERATIVE CELL SALVAGE 1. Aim/Purpose of this Guideline 1.1. The aims of this policy document is to provide information that will allow Clinicians to safely identify suitable patients undergoing elective and/or emergency surgical procedures where Intraoperative Cell Salvage could be used and utilise Intraoperative Cell Salvage in a safe effective manner 2. The Guidance 2.1 Anaesthetics and Theatres Division 2.2 Intraoperative cell salvage 2.3 Introduction While allogeneic (donated) blood can be life saving in heavy haemorrhage situations, it is a limited resource, subject to the threat of future shortages, increasingly expensive and carries a risk. Besides the risk of transmitting infection and wrong blood incidents as reported by the Serious Hazards of Transfusion (SHOT) steering group, allogeneic blood also has effects on the immune system which may cause an increase in post-operative infection rate and healing problems The Health Service Circular, Better Blood Transfusion: Safe and Appropriate Use of Blood (2007), recommends that in order to make transfusion safer, provide better information for patients relating to transfusion and avoid unnecessary use of blood in clinical practice, blood transfusion must be an integral part of care and clinical governance responsibilities The circular further recommended that effective alternatives to allogeneic blood transfusion be explored, including further progress in the use of autologous blood transfusion techniques such as Intra-operative Cell Salvage (ICS) ICS is used routinely in some areas of surgical practice. The technique involves aspirating blood lost within the surgical field into a collection reservoir. Blood is mixed with an anticoagulant solution containing either heparin or citrate to prevent clotting. A double lumen aspiration line is used to deliver the anticoagulant to the end of the double lumen line. As blood enters the collection reservoir it is filtered to remove large particulate debris. On processing the salvaged blood it is centrifuged and washed to produce red blood cells suspended in saline for reinfusion back 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 used by appropriately trained staff, ICS is a safe and cost effective method of reducing allogeneic transfusion. 2.4 Policy Statement Utilising appropriate alternatives to blood transfusion is cost-effective and complies with clinical governance requirements. Page 1 of 12

2 2.4.2 The collection and re-infusion of autologous red blood cells provides an important contribution to reducing the demand for allogeneic blood. However, it is only one aspect of the Trusts Blood Conservation Strategy which supports safe and appropriate transfusion practice. 2.5 Objectives The objectives of this policy are to provide a rational and practical framework on which to maximise patient safety during Intraoperative Cell salvage by Assisting clinical staff in the identification of patients and procedures considered suitable for ICS, outlining the indications/contraindications and possible hazards Providing clear written information about the risks and benefits of autologous transfusions from blood salvaged intra-operatively Assisting clinical staff to minimise avoidable risks of autologous transfusions from blood salvaged intra-operatively Assisting clinical staff to provide appropriate advice on options for treatment particularly where patients are anxious about risks associated with allogeneic blood transfusion Promoting safer transfusion is part of clinical governance responsibilities. 2.6 Contraindications and Warnings The risk benefit ratio of ICS must be assessed for each individual patient and ultimately the responsibility lies with clinician 2.7 Contraindications Intraoperative Cell Salvage should not be used in the following situations, however for patients who have particular indications (see below) these contra-indications are relative and need to be considered in the context of an individual s balance of risk and benefit Bowel Contents in the surgical field Overt infection Heparin induced thrombocytopenia when heparin is the anticoagulant of choice (a citrate containing anticoagulant solution may be used instead) Malignancy. The use of ICS in patients undergoing surgery for malignant disease is controversial, although there is increasing evidence that supports its safe use in cancer surgery. Some hospitals now use ICS routinely during surgery for malignant disease. The decision to use cell salvage in the presence of malignant disease should be made by a surgeon and an anaesthetist familiar with the issues Page 2 of 12

3 2.8 Warnings Pain busters (infusions of Bupivicaine local anaesthetic used in orthopaedic surgery) should not be used concurrently with cell salvage devices which use blood collected from drains post-operatively. This is due to the potential risk of re-infusing blood contaminated with Bupivicaine ICS must be temporarily discontinued when substances not licensed for IV use are used within the surgical field and could potentially be aspirated into the collection reservoir. The standard theatre suction should be used to aspirate the surgical field and the wound should be irrigated with 0.9% Sodium Chloride before resuming ICS Some examples of non-iv materials that should not be aspirated into the Intraoperative Cell Salvage system include: Antibiotics not licensed for IV use Iodine Topical Clotting Agents Orthopaedic Cement Hydrogen Peroxide Chlorhexidine Irrigation Misoprostal (Obstetrics) Gastric/pancreatic secretions should not be aspirated into the system as they may cause enzymatic haemolysis and are not reliably removed by the washing procedure Pleural effusions should not be aspirated and should be drained prior to cell salvage. However, blood which subsequently accumulates in the pleural space may be aspirated. 2.9 Obstetric Cell Salvage. There is no evidence to support initial aspiration of amniotic fluid to waste, as amniotic fluid is removed during the washing process. Use one suction device. See separate guideline Intraoperative Blood Cell Salvage for Obstetrics (HYPERLINK) 2.10 Cautions The use of Hartman s Solution will inhibit the action of citrate based anticoagulants (e.g. ACDA) Reinfusion of blood from the reinfusion bag when it is still connected to the cell saver or when it has been disconnected but air remains in the bag, may lead to air embolism. A pressure cuff must not be used for re-infusion and where possible, air should be evacuated from the reinfusion bag prior to reinfusion Indications and Patient Selection Intraoperative Cell salvage systems may be used in all adult and paediatric patients undergoing elective and/or emergency surgical procedures where there is a potential for significant blood loss, provided there are none of the above contraindications Particular indications for ICS include: Patients who have rare blood groups or multiple antibodies for whom it may be difficult to find allogeneic blood Page 3 of 12

4 Patients who, for moral, religious or other reasons, are unwilling to receive allogeneic blood and have given their consent to receiving autologous blood collected using ICS (all such decisions must be documented) If the surgical procedure to be carried out for patients for whom ICS is indicated but is also associated with any of the listed contraindications, the potential risks and hazards must be discussed with the patients and their agreement to undergo ICS documented Patient Information Patients likely to lose a significant amount of blood in and after routine surgery should receive information about Blood Transfusion and alternative resources such as ICS For patients undergoing emergency surgery the decision to use ICS is at the discretion of the surgeon and anaesthetist Conditions for Using Intraoperative Cell Salvage The ICS system should be used in accordance with the manufacturer s guidelines, modified by research The ICS system should be run in automatic mode Contradictions must be considered as listed above All staff who set up or operate ICS systems will have received formal documented competency based training Staff must comply with hospital policies for infection control, management of sharps and blood transfusion Aseptic technique must be used at all times Anticoagulant Anticoagulant prepared by the operator (e.g. hepranised saline) must be labelled clearly Wash Solution % IV Grade Saline should be used as the wash solution The minimum wash volume as outlined in the manufacturer s guidelines for the size of the centrifuge bowl in use and the type of surgical procedure should be used in all but the most urgent situations Labelling Page 4 of 12

5 All salvaged blood must be labelled and include the following details Full Name Date of birth Hospital number Collection start date and time Expiry date and time Completing the autologous re-infusion label and labelling the reinfusion bag is not acceptable, before the patient is in the operating theatre, or after cell salvage is complete and the patient has moved away from the ICS device. The patient details must be taken from the identification band attached to the patient not from any medical records or charts that may be present in the operating theatre Re-infusion Prescribing Responsibilities: Salvaged blood reinfusion must be prescribed by a doctor (usually the anaesthetist) on documentation approved by the Trust Rarely ICS is requested to be set up as a closed-circuit system (in continuity) where blood aspirated from the wound is processed and passed into a reinfusion bag connected by an intravenous fluid administration set (suitable for blood transfusion) to an intravenous cannulae in the patient. This request will require forward planning. The closed circuit allows adjustment of the rate at which the red cells are re-infused by adjusting a roller clamp on the fluid administration set and the height of the reinfusion bag. A pressure cuff should not be applied to increase the flow rate because of the risk of air embolism. The same reinfusion bag may fill and empty many times during an operation. NOTE This should only be undertaken by an experienced user as the risk of air embolus is increased Alternatively, and more commonly, blood may be collected into a reinfusion bag which is not connected by an intravenous fluid administration set to the patient. The bag is disconnected from the ICS device when it is full or at the end of the surgical procedure and is subsequently connected and reinfused to the patient as in a closed- circuit system The reinfusion bag must be kept beside the patient at all times The reinfusion bag must not be placed into any refrigerator Currently it is recommended a leucodepletion filter is used for reinfusion of blood salvaged in the presence of malignancy and for all obstetric salvaged blood (see separate guideline). However the evidence to support this recommendation is poor and it is acceptable for the prescribing clinician to omit the leucodepletion filter Reinfusion of other salvaged blood should follow standard blood transfusion practice i.e. using a standard blood giving set to reinfuse red cells as directed in the RCHT Blood Transfusion Policy. The doctor should prescribe salvaged blood for re-infusion after surgery in the same manner as allogenic blood. The patient details on the reinfusion bag must be carefully checked against the details on the identification band attached to the patient before connecting the reinfusion bag to the patient. Page 5 of 12

6 The expiry time on the re-infusion bag must be checked prior to commencing the reinfusion and the prescription must be signed The reinfusion of salvaged blood must be documented in the appropriate section of the patients notes Expiry The collection, processing and reinfusion of salvaged blood should be completed within the Trust timeframe of 6 Hours Any blood that has not been re-infused within the timeframe specified in the guidelines should be disposed of appropriately Documentation The collection and reinfusion of salvaged blood must be accurately documented including the occasions when it is not re-infused All adverse incidents must be documented in the patients medical records and in accordance with the Trust Blood Transfusion Policy. If necessary a DATI report should be completed in accordance with the Trust Incident Reporting policy Bedside pre-reinfusion checks and patients observations must be performed and recorded during autologous blood reinfusion in the same way as transfusion of allogeneic blood in accordance with the Trust Blood Transfusion Policy. Additional observations are at the discretion of the clinical staff based on an individual patient assessment The Trust/organisation must ensure that adequate records are retained in cases where ICS is used Disposal of used salvage equipment Following use, all cell salvage disposable equipment will be disposed of in accordance with the Trust Health and Safety Policy for disposable of equipment contaminated with blood (RCHT policy for clinical waste) 2.21 Cleaning and Disinfection of Cell Salvage Machines Following use, the cell salvage machine will be cleaned in accordance with the Trust Infection Control Policy, including procedures for cleaning equipment following high risk cases Following contamination of the equipment internally, the equipment should be removed from use, identified as a potential biohazard and referred to the Blood Conservation Service The Management of Massive Transfusion As with the transfusion of large volumes of allogeneic red cells, the return of large volumes of salvaged red cells will coincide with the depletion of platelets and clotting factors associated with massive blood loss Page 6 of 12

7 In the event of a massive transfusion, it is vital to consider the need for additional transfusions of platelets; fresh frozen plasma and cryoprecipitate (see massive haemorrhage guideline) 2.23 Technical Problems Technical problems with the ICS should be reported to the cell salvage co-ordinator who will then contact the manufacturer if applicable All technical problems with machines will be documented and outcomes actioned Any adverse events relating to the ICS device must be reported in accordance with the Trust Incident Reporting Policy. Additionally where appropriate, reporting to the relevant external bodies should be undertaken e.g. SHOT, Medicine and Healthcare products Regulatory Agency (MHRA) 2.24 Resources The provision of safe ICS requires adequate resources for the formal, documented training of all staff who set up or operate the equipment and for the regular maintenance and prompt repair of ICS equipment Training The Blood Conservation Service will maintain records of all persons who have received training in the use of the ICS devices Theoretical and practical training should be delivered and individual staff competency assessed before staff set up or operate ICS equipment without supervision Update training is recommended after any reasonable length of time without practical use of the ICS device; If a learning need is identified by an individual member of staff or supervisor; if there are any changes in the product from the manufacturer or a change in the product due to the Trust trialling/purchasing new products; if there is any change to national and/or local guidelines relating to any aspect of autologous transfusion (including changes to the Trust Blood Transfusion Policy) 2.26 Individual Responsibilities Individual staff must ensure that they are adequately trained and competent in the use of the ICS system and their individual responsibilities according to their area of work, i.e. operator, anaesthetic, scrub, recovery and ward staff and to act within the NMC/HPC code of conduct and scope of professional practice as extended by this protocol References Page 7 of 12

8 3. Monitoring compliance and effectiveness Element to be monitored Lead All ICS collections ICS training competencies Catherine Ralph, Carol McGovern, John Faulds Tool Monitoring sheet for each collection (appendix 1) Training database Frequency Every blood collection is monitored All training recorded Reported monthly to BC team Report shared to HTT-Monthly and HTC-Quarterly Reporting Hospital Transfusion Committee (HTC) arrangements Interrogated by members of committee and documented in minutes Acting on recommendations and Lead(s) Change in practice and lessons to be shared of HTC meeting. Blood conservation team, lead or co-ordinator will undertake any recommendations within reasonable timeframes Required training actions will be actioned by Carol McGovern Required changes to practice will be identified and actioned within a month. A lead member of the blood conservation team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders. 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 8 of 12

9 Appendix 1. Governance Information Document Title Intra-operative Cell Salvage Date Issued/Approved: Date Valid From: Date Valid To: Directorate / Department responsible (author/owner): Contact details: Catherine Ralph Blood Conservation Lead, Consultant Anaesthetist John Faulds Blood Conservation Coordinator Brief summary of contents This policy covers all aspects of Intraoperative Cell Salvage in the surgical setting. Suggested Keywords: Target Audience Executive Director responsible for Policy: Cell salvage. Blood conservation. RCHT PCH CFT KCCG Medical Director Date revised: This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Divisional Manager confirming approval processes Intra-operative Cell Salvage Blood Conservation Coordinator Hospital Transfusion Team Hospital Transfusion Committee Duncan Bliss Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? Not Required {Original Copy Signed} Internet & Intranet Intranet Only Clinical / Anaesthetics CQC16 Intra-Operative cell salvage in obstetrics Yes Page 9 of 12

10 Version Control Table Date Version No Summary of Changes 27 Mar 12 V2.1 Warning added to paragraph Dec 14 V2.2 Minor Changes Changes Made by (Name and Job Title) Catherine Ralph, Blood Conservation Lead Catherine Ralph, Blood Conservation Lead All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 10 of 12

11 Appendix 2. Initial Equality Impact Assessment Form Name of Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy) (Provide brief description): Directorate and service area: Medical Is this a new or existing Policy? Existing Name of individual completing assessment: Catherine Ralph 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? Telephone: To provide information that will allow clinicians to safely identify suitable patients undergoing elective and /or emergency surgical procedures where ICA could be used and utilise it in a safe effective manner. 2. Policy Objectives* To provide a rational and practical framework on which to maximise patient safety during ICS. 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? Safe and effective use of ICS during surgery Monitor all episodes of ICS usage. All patients undergoing surgical procedures for which blood loss can be collected into the cell saver. No b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age Sex (male, female, transgender / gender reassignment) Page 11 of 12

12 Race / Ethnic communities /groups Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Positive impact, Jehovah Witnesses can benefit. Marriage and civil partnership Pregnancy and maternity Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. Yes No 9. If you are not recommending a Full Impact assessment please explain why. Signature of policy developer / lead manager / director Date of completion and submission Names and signatures of members carrying out the Screening Assessment Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Catherine Ralph Date Page 12 of 12