POST-OPERATIVE REINFUSION OF SHED BLOOD USING A REINFUSION DRAINAGE SYSTEM FOR ORTHOPAEDIC JOINT REPLACEMENT/JOINT SURGERY Version 5 Name of responsible (ratifying) committee PORTSMOUTH HOSPITALS NHS TRUST BLOOD TRANSFUSION COMITTEE Date ratified 24th October 2014 Document Manager (job title) Transfusion Practitioner Date issued 26th November 2014 Review date 25th November 2017 Electronic location Trust Intranet Related Procedural Documents PHT Blood Transfusion Policy Key Words (to aid with searching) Reinfusion drain, autologous, blood, homologous Version Tracking Version Date Ratified Brief Summary of Changes Author 5 24/10/2014 Two Yearly Competency & Page 8 Amendment Kay Heron CONTENTS Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 1 1. 2. 3. 4. 5. 6. 7. 8. 9. QUICK REFERENCE GUIDE....................................................................................................... 3 INTRODUCTION.......................................................................................................................... 5 PURPOSE ................................................................................................................................... 5 SCOPE ........................................................................................................................................ 5 DEFINITIONS .............................................................................................................................. 6 DUTIES AND RESPONSIBILITIES .............................................................................................. 6 PROCESS ................................................................................................................................... 7 TRAINING REQUIREMENTS .................................................................................................... 10 REFERENCES AND ASSOCIATED DOCUMENTATION .......................................................... 10 MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL DOCUMENTS ............................................................................................................................ 11 Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 2 QUICK REFERENCE GUIDE This policy must be followed in full when developing or reviewing and amending Trust procedural documents. For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy. Any blood collected in the drain reservoir must be collected for a maximum total of 6 hours and reinfused within 4 hours The systems must only be used for a maximum of 1500mls of collected blood for reinfusion, after which it must revert to a drainage system only The scrub nurse/ODP must ensure that all clamps are closed and the two-leur lock joints are tight. Blood must not be allowed to seep into the drain until defibrination has occurred Theatre team must ensure the recovery team knows the time the drain can be opened. This should be documented in the nursing notes and on the drainage bag. This is 20 minutes after closure of the deep cavity. In TKR surgery, if the tourniquet is deflated after the wound is fully closed, the time should start from the deflation In recovery the reservoir should be kept upright to ensure the filters stay dry and the drain should be opened when de-fibrination is complete Expel any air from the bellows away from the patient Ensure the clamp directly under the bellows is tightly closed and undo the clamp between the wound and the reservoir The time of opening must be documented on the drain and the patient notes to ensure the salvaged blood has started to re-transfuse within the time limit Using the bellows system, expel the blood into the reinfusion bag and re-clamp to allow for more drainage Once the system has finished collecting and re-infusing autologous blood within the designated timeframe, the system may still be used as a wound drain. If the patient is continuing to bleed more than 6 hours post operation, contact the medical team involved Reinfusion should commence once all clamps are back in place. Reinfusion can continue whilst collection is still going on There are 3 main areas involved in the reinfusion of shed blood; theatres, theatre recovery and ward areas. Each clinical area has specific responsibilities, these are described below: Theatre There should be a final washout with normal saline prior to closing the wound The tourniquet release time MUST be recorded by the scrub nurse/ODP in the patient’s notes The anesthetist will prescribe the autologous re-transfusion on the usual fluid prescription chart Recovery The recovery nurse/ODP is responsible for completing the patient details onto the drainage collection chamber and reinfusion blood bag using a permanent marker. This must include 4 points of patient ID; surname, first name, date of birth and unique identification number (i.e. NHS, Hospital or District Number) but it must also be dated, timed and signed The recovery nurse/ODP must wait 20 minutes after release of the tourniquet before priming the collection chamber. This allows the body to defibrinate blood and prevents clotting of reinfused blood (Faris et al 1991). The time the collection begins MUST be recorded on the device, the nursing notes and the prescription chart Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 3 The collection chamber must be placed below the affected limb and kept upright, once the clamps have been released Wards and/or recovery When the collection chamber has 250 – 500mls of blood in it OR the 6 hours allowed for collection is almost elapsed, the blood must be transferred into the blood transfusion bag After 6 hours the drain can be used as a normal wound drainage system but the contents must not be re-infused Transferring collected shed blood into the reinfusion bag The device is a closed unit and blood is collected from the drainage chamber to the transfusion bag by the method detailed in section 8 All autologous shed blood must be transfused through a blood giving set at a rate of 200mls/hr Once shed blood has been collected into a transfusion bag, it must be administered immediately. IT MUST NOT UNDER ANY CIRCUMSTANCES be removed from the patient’s bedside, stored on the ward, in a ward fridge or blood fridge One qualified staff member must check the details on the blood bag against the prescription chart and the patient identity band, in accordance with Trust Blood Transfusion Policy Patient monitoring and observations in line with the Trust Transfusion Policy, should be performed Empty blood bags must be kept in accordance with Trust policy and then disposed of in the clinical waste Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 4 1. INTRODUCTION Practice in autologous blood transfusion has increased in response to several initiatives and reports: Recommendations from the Serious Hazards of Transfusion (SHOT 2004) enquiry, regarding safety of patients receiving transfusion Department of Health (2007) Better Blood Transfusion 3 circular, which identifies those alternatives to donor blood, and the appropriate use of autologous blood transfusion, should be pursued. This includes postoperative cell salvage Department of Health (1998) White Paper, The New NHS – Modern and Dependable, which suggests that autologous blood transfusion is seen as a valuable advance in improving clinical practice Potentially lower risks of infection or febrile episodes following autologous blood transfusion in comparison to bank blood (Newman et al, 1997, Gleason and Leone, 1997, Murphy et al, 1991, Tartter, 1988) European Blood Directive 2005, suggests alternative strategies must be considered for effective use of blood Indications for use Post operative autologous blood collection for reinfusion after orthopaedic surgery e.g. any joint surgery Patients will need to receive information regarding options for autologous transfusion during the pre assessment process Contraindications Do not use this type of reinfusion device if any of the following are present or are suspected: Infected wound Bacteraemia or Septic contamination of the autologous blood Malignant lesions in the area of blood collection Presence in collected blood of a substance not suitable for reinfusion e.g. adrenaline or peroxide (NB See page 8 for further clarification) 2. PURPOSE The purpose of this policy is to: Provide a clear framework and guidance for safe reinfusion of a patient’s own blood, throughout Portsmouth Hospitals NHS Trust To ensure a consistent approach to the storage, prescribing, handling and administration of the patient’s own blood throughout the Trust To ensure that all members of staff involved in any stage of the process of transfusing patient’s own blood are aware of their role and the legal aspects of this practice 3. SCOPE Only Registered Nurses (RN) or Operating Department Practitioners (ODP) who have been trained in the use of the Post Operative Autologous blood transfusion system, are allowed to collect and reinfuse blood using this system. Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 5 Ward / Department managers must satisfy themselves that the RNs / ODP’s who undertake this practice have achieved the level of education and competence required. The appropriate manager should keep a record of staff achieving competence. All staff involved in the administration of autologous blood transfusion must be familiar with the Trusts Administration of Blood Components Policy and have completed the Administration of Blood Components competency. This policy should be read and applied in conjunction with the Trust Blood Transfusion Policy, which is located on the Trust Intranet ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’ 4. DEFINITIONS Homologous Autologous Reinfusion – – – ODP RN – – Donated blood from an unknown donor The patients own blood Giving back patients own shed blood using a post-operative reinfusion device Operating Department Practitioner Registered Nurse 5. DUTIES AND RESPONSIBILITIES The Hospital Transfusion Committee The Committee is comprised of members of the Hospital Transfusion Team and representatives from all clinical areas were a blood component/product is administered. It has responsibility for ensuring that transfusion practice throughout PHT adheres to local policies. Hospital Transfusion Practitioner The Practitioner is responsible for: Acting as the main point of contact for staff requiring information / guidance on the use of autologous drains. Prescribing Clinicians Prescribing Clinicians are responsible for: Obtaining and documenting consent or inability to provide consent Where practical - informing patients of the reasons for transfusion, their right to refuse transfusion and of the risks and benefits Providing information about alternatives to blood transfusion where appropriate All Ward/Line Managers All managers have a responsibility: To be aware of this policy and associated guidelines Releasing staff for training Integrating compliance into the Knowledge and Skills Framework and appraisals for all staff Ensuring appropriate evidence of compliance is gained during the appraisal process Ensure their staff are aware of and understand this policy and comply with its content Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 6 All staff involved in the processes associated with reinfusion of blood All staff members involved have a responsibility to: Attend training relevant to their role in the process Comply with this policy at a level commensurate with their involvement Report all adverse incidents and near misses 6. PROCESS Principles of Autologous Blood Collection and reinfusion systems Any blood collected in the drain reservoir must be collected within 6 hours of opening the drain in accordance with manufacturer’s guidelines and reinfused within 4 hours. The systems must only be used for a maximum of 1500mls of collected blood for reinfusion, after which it must revert to a drainage system only. The scrub nurse/ODP must ensure that all clamps are closed and the two-leur lock joints are tight. Blood must not be allowed to seep into the drain until defibrination has occurred. Theatre team must ensure the recovery team knows the time the drain can be opened. This should be documented in the nursing notes and on the drainage bag. This is 20 minutes after closure of the deep cavity. In TKR surgery, if the tourniquet is deflated after the wound is fully closed, the time should start from the deflation. In recovery the reservoir should be kept upright to ensure the filters stay dry and the drain should be opened when de-fibrination is complete. Expel any air from the bellows away from the patient. Ensure the clamp directly under the bellows is tightly closed and undo the clamp between the wound and the reservoir. The time of opening must be documented on the drain and the patient notes to ensure the salvaged blood has started to re-transfuse within the time limit. Using the bellows system, expel the blood into the reinfusion bag and re-clamp to allow for more drainage. Once the system has finished collecting and re-infusing autologous blood within the designated timeframe, the system may still be used as a wound drain. If the patient is continuing to bleed more than 6 hours post operation, contact the medical team involved. Reinfusion should commence once all clamps are back in place. Reinfusion can continue whilst collection is still going on. CLINICAL AREAS INVOLVED IN THE REINFUSION PROCESS There are 3 main areas involved in the reinfusion of shed blood; theatres, theatre recovery and ward areas. Each clinical area has specific responsibilities, these are described overleaf: Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 7 Theatre Drugs such as lignocaine, bupivacaine, adrenaline, peroxide or any other drug not licensed for intra-venous use or contra-indicated for reinfusion, should NOT be left in the wound. Antiseptic solutions should also be washed away using sodium chloride 0.9% irrigation (normal saline). There should be a final washout with normal saline prior to closing the wound. Local anaesthetic and/or adrenaline can be injected into the soft tissues during surgery, and in these cases shed blood can safely be reinfused (Reference – Wallace et al 2012). The administration of these drugs should be documented in the notes, specifying they were injected into the tissues not the cavity. The tourniquet release time MUST be recorded by the scrub nurse/ODP in the patient’s notes. The anaesthetist will prescribe the autologous re-transfusion on the usual fluid prescription chart. The prescription must state ‘reinfusion of shed blood must be completed within 4 hours at a rate of 200mls/hr’ (Newman 1997). Recovery To ensure correct patient identification – right product to right patient – The recovery nurse/ODP is responsible for completing the patient details onto the drainage collection chamber and reinfusion blood bag using a permanent marker. This must include 4 points of patient ID; surname, first name, date of birth and hospital number but it must also be dated, timed and signed. The recovery nurse/ODP must wait 20 minutes after release of the tourniquet before priming the collection chamber. This allows the body to defibrinate blood and prevents clotting of reinfused blood (Faris et al 1991). The time the collection begins MUST be recorded on the device, the nursing notes and the prescription chart. The collection chamber must be placed below the affected limb and kept upright, once the clamps have been released. Ensure the anesthetist has correctly prescribed the autologous blood If 250 – 500mls has drained and transfusion is necessary, follow the details in the next section Wards and/or recovery When the collection chamber has 250 – 500mls of blood in it OR the 6 hours allowed for collection is almost elapsed, the blood must be transferred into the blood transfusion bag. After 6 hours the drain can be used as a normal wound drainage system but the contents must not be re-infused. Transferring collected shed blood into the reinfusion bag The device is a closed unit and blood is collected from the drainage chamber to the transfusion bag. All autologous shed blood must be transfused through a blood giving set at a rate of 200mls/hr. Once shed blood has been collected into a transfusion bag, it must be administered immediately. IT MUST NOT UNDER ANY CIRCUMSTANCES be removed from the patient’s bedside, stored on the ward, in a ward fridge or blood fridge. One qualified staff member must check the details on the blood bag against the prescription chart and the patient identity band, in accordance with Trust Blood Transfusion Policy. Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 8 Patient monitoring and observations in line with the Trust Transfusion Policy, should be performed. Empty blood bags must be kept in accordance with Trust policy and then disposed of in the clinical waste. PATIENT INFORMATION Inform the patient about the intended transfusion therapy and giving them a full explanation, giving them the opportunity to discuss and raise any concerns they may have. The risks and benefits of transfusion must be explained and documented. Prescriber responsibility The prescription of blood products is the responsibility of a Clinician / designated Nurse Practitioner. The Prescription Prescribe on designated prescription sheets, stating: 4 points of patient identification, duration and infusion rate. Identity Band All patients, including unconscious patients, must have surname, first name, date of birth, and a patient identification number, recorded on their identity band. Observations and administration Prior to the start of the reinfusion: Record temperature, pulse and blood pressure and respirations Check pulse, blood pressure, respirations and temperature 15 minutes after starting the reinfusion Observe the patient throughout the transfusion Deteriorating Patients. Consider a transfusion reaction if the patient’s condition deteriorates within the first 15 minutes of a transfusion Immediately stop the transfusion and inform the medical team responsible for the patient Report to Bloodbank on ext 6539 Complete a Transfusion Reaction Form, available from blood bank, if a reaction is suspected Transfusions should be given in clinical areas where frequent visual and verbal contact can take place. Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 9 Documentation (All patients) Medical record The patient’s notes should contain the volume re-transfused and any adverse effects. A follow up note to record the clinical response should be recorded in the patient notes. Awareness All medical staff must be aware of the beliefs and individual wishes of the Jehovah’s Witness patient in relation to receiving any blood component. 7. TRAINING REQUIREMENTS The additional education and skills training required for RNs/Practitioners and ODP’s to undertake this practice will be provided in the Trust by an expert in practice. Assessment of practice will be undertaken in the usual practice environment of the RN or ODP and will be competency based and updated annually. Assessors must be competent to undertake this practice and must hold a recognised qualification in assessing (i.e. 998, City and Guilds D32/33 or 730). The RN or ODP is responsible for their decision to transfuse blood using this device. If the practitioner is unsure of any aspect of the system they should seek advice from their clinical lead. Assessment of competency must be completed prior to undertaking any post-operative reinfusion. Competency can be found on the Trust Learning and Development website To be read in conjunction with the Trust Blood Transfusion Policy available on the intranet. 8. REFERENCES AND ASSOCIATED DOCUMENTATION Guidelines for blood recovery and reinfusion in surgery and trauma: American Association of Blood Banks, 1993. DIRECTIVE 2002 /98/EC OF THE EUROPEAN PARLIAMENT. Official Journal of the European Union, 27th January 2003. Better Blood Transfusion Appropriate use of blood. DOH. 2002. DOH (1998) The New NHS – Modern and Dependable. Faris, P.M. et al (1991) Unwashed and filtered shed blood collected after knee and hip arthroplasty. The Journal of Bone and Joint Surgery 73(8) 1169 –1178. Gleason DH, Leone BJ. Cost effectiveness of blood transfusions; the risks and the benefits, 1997. Guidelines for the Clinical Use of Red Cell Transfusions: British Committee for Standards in Haematology, Blood Transfusion Task Force in collaboration with the Royal College of Nursing and the Royal College of Surgeons of England. British Journal of Haematology 2001; 113, p2431. Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 10 Statutory Instrument 2005 No. 50, The Blood Safety and Quality Regulations 2005: Handbook of Transfusion Medicine (2001), D.B.L. McClelland, Third Edition. The Stationery Office Norwich Newman JH, Bowers M, Murphy J. The clinical advantages of autologous. The Journal of Bone and Joint Surgery, 1997: 79(4) 630 – 633. Murphy P, Heal JM, Blomberg N. Infection or suspected infection after hip replacement surgery with autologous or homologous blood transfusions. Transfusion, 1991: 31, p 212 – 217. SHOT steering group: Annual Report, 2002. Tartter PI. Blood Transfusion and Infectious Complications Following Colorectal Cancer Surgery. British Journal of Surgery, 1988: 75, p 789 – 792. An Organisation-Wide Policy for the Development and Management of Procedural Documents: NHSLA, May 2007. www.nhsla.com/Publications/ Wallace DF, Emmett SR, Kang KK, Chahal GS, Hiskens R, Balasubramanian S, McGuinness K, Parsons H, Achten J, Costa ML (2012) The safety of peri-articular local anaesthetic injection for patients undergoing total knee replacement with autologous blood transfusion. The Journal of Bone and Joint Surgery 94-B No 12 16323 - 1636 9. MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL DOCUMENTS Assessment of competency must be completed prior to undertaking any post-operative reinfusion. Competency can be found on the Trust Learning and Development website. To be read in conjunction with the Transfusion Policy, available on the intranet Only staff aware of their legal, ethical and professional responsibilities, should be involved with the transfusion process – Assessment to Level 2 of the Trust Competency for Blood Administration Only staff who have completed biannual updates and competency assessment, can participate in the clinical process – Competency available on the learning and development site. Patients are monitored according to hospital policy and any untoward events (including suspected transfusion reactions) are immediately clinically managed and promptly reported to the Hospital Transfusion Committee (HTC) – monitored by annual local audit and spot checks of data recording and bedside checks and participation in national audit initiatives. Serious Adverse and Events and Near Miss incidents are reported to the Trust Clinical Incident reporting system in accordance with local protocols. Reports of serious adverse events or reactions and near miss incidents are submitted to the Serious Adverse Blood Reactions and Events (SABRE) and the Serious Hazards of Transfusion (SHOT) initiative by the relevant staff. 1. EQUALITY IMPACT STATEMENT Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 11 This policy has been assessed accordingly. All policies must include this standard equality impact statement. However, when sending for ratification and publication, this must be accompanied by the full equality screening assessment tool. The assessment tool can be found on the Trust Intranet -> Policies -> Policy Documentation. Our values are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviours our employees display in the workplace. Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do. We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust: Respect and dignity Quality of care Working together No waste This policy should be read and implemented with the Trust Values in mind at all times. Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 12 1. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS Minimum requirement to be monitored Lead All staff involved in care of post-op drains to be competency assessed Theatre/ ward managers Tool Competency records Frequency of Report of Compliance 2 yearly Reporting arrangements Policy audit report to: Lead(s) for acting on Recommendations HTC HTC Policy audit report to: Policy audit report to: This document will be monitored to ensure it is effective and to assurance compliance. The effectiveness in practice of all procedural documents should be routinely monitored (audited) to ensure the document objectives are being achieved. The process for how the monitoring will be performed should be included in the procedural document, using the template above. The details of the monitoring to be considered include: The aspects of the procedural document to be monitored: identify standards or key performance indicators (KPIs); The lead for ensuring the audit is undertaken The tool to be used for monitoring e.g. spot checks, observation audit, data collection; Frequency of the monitoring e.g. quarterly, annually; The reporting arrangements i.e. the committee or group who will be responsible for receiving the results and taking action as required. In most circumstances this will be the committee which ratified the document. The template for the policy audit report can be found on the Trust Intranet Trust Intranet -> Policies -> Policy Documentation The lead(s) for acting on any recommendations necessary. Post-operative Cell Salvage Version 5. Issued: 26/11/2014 Review: 25/11/2017 13