Guideline for the Safe Administration of the Intra and Post Operative Cell Salvage Donation

1. Introduction
2. Background
3. Key Safety Issues
4. Indications for Use
5. Contraindications for Use
6. Patient Information
7. Jehovah’s Witnesses
8. Labelling
9. Maintaining the viability of the donation
10. Prevention of bacterial contamination
11. Storage
12. Re-infusion, time scale & location
13. Management of massive reinfusion
14. Risks of reaction to re-infusion
15. Transfer of donations between departments
16. Disposal of unused donations
17. Documentation of fate of the donation/infusion
18. Reporting adverse events
19. Key contacts
20. Glossary

1. Introduction

Intra operative and post operative cell salvage are techniques used to reduce the exposure of patients to donor blood.  Intra operatively, it involves the immediate collection of whole blood from the patient which once processed, provides fresh red cells that can be re-infused intra operatively.  Post operative cell salvage involves the reinfusion of residual blood drained from the wound site via a filter (Belovac™) system within 6 hours of the end of the operation.

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2. Background

The potential risks of disease transmission (vCJD, viral & bacterial contamination) during transfusion of donor blood are, although rare, ever present. To prevent this and the immune modulatory effect of donor transfusion, the use of cell salvage is encouraged in appropriate patients. Used appropriately, it also reduces demand for banked donor blood especially during massive haemorrhage.

Also, the National Blood Transfusion Committee publication, “Patient Blood Management: An evidence-based approach to patent care” (2014) recommends that effective alternatives to allogeneic blood transfusion be explored, including the appropriate use of autologous blood transfusion techniques such as Intraoperative and Post operative cell salvage.

In the hands of experienced perfusionists, anaesthetists and other healthcare workers, cell salvage is safe to use on appropriate patients such as those receiving surgery for cardiac, spinal, orthopaedic, obstetric, vascular, trauma and other conditions.  It requires adherence to standard operating procedures and Trust guidelines, particularly with respect to safety aspects such as labelling of the donations, correct usage of the donations and the time scale in which it is safe to re-infuse the donated blood into the patient.

The cost benefits of cell salvage far outweigh those incurred using the cell salvage systems/disposables when compared to the cost of 1 or more units of donor blood, for example currently one unit of donor red cells costs £133.44 whereas the disposables for intra operative cell salvage which can process the equivalent of numerous units of donor blood cost on average £60 each.

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3. Key Safety Issues

• All staff using either intra or post operative cell salvage systems must be trained and where appropriate, competency assessed and must work within the sphere of their individual competence.
• Labelling – a robust system is required to ensure that full positive patient identification of the cell salvaged donation is in place at all times
• Reinfusion of the intra operative donation must be monitored & administered within theatre/recovery area
• The fate of each unit of blood drawn off the patient must be clearly documented (i.e. its transfusion into the patient)
• All adverse events associated with the process of intra/post operative cell salvage must be reported to the Hospital Transfusion Team (HTT) who will then report to SHOT (Serious Hazards of Transfusion) & MHRA (Medicines Healthcare Regulatory Agency) if necessary.
• Off licence use of intra operative cell salvage in cancer patients has been shown in a number of studies to be safe if blood is re-infused using a 5-log leucocyte depletion filter (not a microaggregate filter) to ‘trap’ and prevent any cancer cells from being systemically re-infused. The decision to use cell salvaged blood during cancer surgery is between the patient and their surgeon and the patient’s consent to this procedure must be fully documented. Any blood salvaged from a tumour field should be re-infused using a leucocyte depletion filter

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4. Indications for Use

Both intra operative and post operative cell salvage is indicated in appropriate surgical procedures where the estimated blood loss is 20% or more of the patient’s circulating volume.
If collection takes place intra operatively and transfusion is required, the cell salvage machine will mix the blood collected with an anticoagulant, filter the blood to remove large particulate debris then centrifuge/spin and wash the red cells before reinfusion to the patient.

ICS systems may be used in adult or paediatric elective and/or emergency surgical procedures where the surgical field is not contaminated by faecal or infective matter and where no other contraindications exist

Post operative cell salvage takes place using a collection device attached to a surgical drain that begins re-infusing once the wound has been closed and any excess blood has drained from the wound into the post operative cell salvage collection bag. This then is re-infused intravenously.

Patients may be adults or children admitted for elective or emergency surgery. 

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5. Contra Indications for Use

• Contamination of the surgical field with faeces, urine
• Heparin induced thrombocytopenia when heparin is the anticoagulant of choice (a citrate containing anticoagulant solution may be used instead)

Warnings for use:
ICS should be temporarily discontinued when substances not licensed for Intravenous (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 copious IV normal saline (0.9% NaCl) before resuming ICS.

Contaminating substances examples:

• Non-intravenous substances e.g. antibiotics, cleaning agents e.g. Iodine, topical clotting agents, orthopaedic cement
• Presence of Infection
• Non-intravenous bodily substances e.g. gastric/pancreatic secretions, bone chips, fat
• Sickle cell disease (case by case clinical decision between surgeon, clinical haematologist & cell salvage operator)

Cautions for use:

• Hartmann’s solution can inhibit the action of ACD-A anticoagulant if used as an irrigant or wash solution
• Air present in the primary reinfusion bag (risk of air embolus)

Areas for further consideration:

• Presence in the operative field of malignant tumours with the potential for metastatic spread (the risk benefit ratios of cell salvage can only be made on an individual basis by the medical personnel directly involved in the patient care in consultation with the patient, see section 3).                  
• Amniotic Fluid, the aspiration of amniotic fluid into the intra operative cell salvage collection reservoir should be minimized by using separate suction before starting ICS and to re-infuse collected blood  using a leucocyte depletion filter

NB: Remember in post operative cell salvage there may be specific contra indications for its use in the Manufacturer’s protocol.

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6. Patient Information

Patients considered likely to be candidates to use cell salvage either during or after surgery should receive information about cell salvage before their operation. The process and what to expect should be discussed pre-operatively whenever possible and the discussion documented in the patient’s clinical records. Written information may help to back-up this discussion e.g.  the Patient Information Leaflet ‘Please Ask About Cell Salvage’.

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7. Jehovah’s Witnesses

Jehovah’s Witnesses (JW) regard blood as sacred. On the basis of this deeply held core value, they decline treatment with allogeneic (donor) blood (red cells, white cells, platelets, and plasma).

In relation to autologous (cell salvage) transfusion, JW patients will make a personal decision whether or not to accept this procedure. This includes all forms of intra operative cell salvage and post operative cell salvage. While machines, systems and arrangements vary, each patient will decide how his/her own blood will be handled in the course of a surgical procedure, medical test, or current therapy and some may specifically request that the system be set up to allow for continuous connectivity (‘closed-circuit’).  If they choose to accept cell salvaged blood, their consent to this must be documented in their medical case notes.

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8. Labelling

Cell salvage bags MUST NOT be pre-labelled with patient details.

At the start of blood collection/processing, cell salvage patient identification labels must be handwritten (to prevent identification/labelling errors) at the patient’s side with details taken from the patient’s wristband and then fixed to the blood pack.

Details must contain the following patient information:

• Surname
• First name
• Date of birth
• ID number
• Date & time of collection
• Name of responsible Medical Officer
• Volume re-infused
• The labelled packs should be numbered sequentially in order of withdrawal from the patient
• Time of expiry

As microbiology testing is not performed on the donations, they should be treated as high risk and labelled with the statement: “UNTESTED BLOOD - FOR AUTOLOGOUS USE ONLY”

All information must be clear and legible.

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9. Maintaining the viability of the donation

Upon completion of the cell salvage collection, observe the blood for any signs of discolouration, leakage or clotting; if clots are visible the donation must not be infused.

Intra operative cell salvaged blood must be re-infused within 4 hours of commencement of processing.

Post operative cell salvaged blood must be re-infused within 6 hours of wound closure and sufficient collection of excess blood from the wound.

Any blood that has not been transfused within the timeframe specified in the guidelines should be disposed of in accordance with local policy for dealing with liquid bio hazardous waste, see section 16.

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10. Prevention of bacterial / viral cross contamination

Cell salvaged blood is untested and must be treated as high risk.  Even though both intra operative and post operative systems are ‘closed’ i.e. they are connected to the patient’s vein simultaneously with the start of the collection process, the potential risk of cross contamination between patient and practitioners is relatively high if infection control measures are not adhered to when cell salvage bags are being removed from the patient, practitioners MUST therefore wear personal protective equipment i.e. gloves & apron.

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11. Storage

Cell salvaged blood must NOT be stored.

Blood removed during cell salvage must remain with the patient at all times.  Every care must be taken to prevent the possibility of transfusing the blood to another patient.

Post operative cell salvaged blood can remain at room temperature for up to 6 hours.  By maintaining the donation at room temperature the function of platelets within the donation will be maintained.
Under no circumstances should any intra or post operative cell salvaged blood be placed in a fridge for storage. Doing so may lead to the pack being mistaken for donated blood and inadvertently used on another patient.

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12. Reinfusion, time scale & location

N.B. All attempts to commence reinfusion of intra operative cell salvaged blood must be made whilst the patient is still in theatre.  If it is absolutely necessary to continue the reinfusion outside the theatre area, e.g. in an area for post anaesthetic care, a written standard operating procedure (S.O.P.) should be in place to ensure that the blood is handled and administered in accordance with the LTHT Policy Safer Transfusion Procedures.  No unconnected bags of intra operative or post operative cell salvaged blood should follow a patient to a general ward area.  If this occurs please contact the anaesthetist responsible for the patient to discuss- as soon as possible.  All care should be taken to prevent any units being wasted.

All intra operative cell salvaged blood should be connected / re-infused by the clinician responsible for the cell salvaged donation, using a giving set with a 200 micron filter (as per LTHT Policy Safer Transfusion Procedures, see: http://nww.lhp.leedsth.nhs.uk/common/guidelines/detail.aspx?ID=1864).   The infusion should be completed within 4 hours of processing.

Post operative cell salvage blood should be re-infused using the administration set accompanying the cell salvage system.

Pre transfusion checks of identity are mandatory before administering any cell salvaged blood and must follow those set out in the LTHT Positive Patient Identification Policy, & Policy Safer Transfusion Procedures.  That is, the patient’s full name, date of birth and ID number must be checked against the cell salvage unit of blood and the patient’s wristband (the details of which must be verified with the patient prior to anaesthesia).

Transfusion observations must be recorded on the anaesthetic chart prior to commencement of each unit, 15 minutes into the transfusion and at the end of each unit.  The start and stop time of each unit must also be recorded (the latter is to comply with MHRA regulations 2005).

Any unused bags of intra operative cell salvage blood must be discarded in theatre and not be allowed to leave the theatre area concerned with the donating patient; this is to prevent the donations being inadvertently entered into the main blood supply system.  See section 16.

Intra operative and post operative cell salvage blood from patients known to have markers for viral infections such as HIV, hepatitis B, and hepatitis C must not be allowed to leave theatre unless the infusion has already commenced and the bag must be labelled with the ‘For Autologous Blood Use Only’ statement outlined in section 8.

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13. The Management of massive reinfusion

As with the transfusion of large volumes of allogeneic red cells, the return of large volumes of salvaged red blood cells will coincide with the depletion of platelets and clotting factors associated with massive blood loss, it is vital therefore to consider the need for additional appropriate transfusion support e.g. platelets, fresh frozen plasma and cryoprecipitate (within the confines of personal religious belief).

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

NICE Guidelines (2015); Blood Transfusion, recommend clinical teams consider the routine use of tranexamic acid for patients receiving ICS. And to consider using tranexamic acid for patients undergoing surgery and expected to have massive blood loss e.g. cardiac, complex vascular, major obstetric procedures and pelvic reconstruction and scoliosis surgery. Also, to consider use of tranexamic acid undergoing surgery who are expected to have at least moderate blood loss (>10% blood volume).

The use of tranexamic acid and its safety in relation to the possible increased risk of adverse coagulation should be examined by the clinical team on a case by case basis.

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14. Risks of reaction to reinfusion

Incidents have been reported in the 2014 SHOT report of patients experiencing transfusion reaction to intra and post operative cell salvage blood, such as: hypotension, shortness of breath, vomiting and pyrexia +/- rigors.  This could be due to cytokines being present within the cell salvage blood or adverse reaction to the anticoagulant within the blood pack. 

Therefore, to comply with BCSH (British Committee for Standards in Haematology) & MHRA requirements, the patient should be observed throughout the transfusion of intra operative or post operative cell salvaged blood for signs and symptoms of acute transfusion reaction.  Observations must be recorded and signs and symptoms treated accordingly.

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15. Transfer of donations between departments

All cell salvage reinfusion systems must be attached to the patient before leaving theatres. 

On arrival at recovery or ward areas, staff receiving the patient, must verify the patient details on the cell salvaged donation bag match those of the patient to whom it is attached to ensure the correct blood is being transfused to the correct patient.

Any concerns regarding patient identity: stop the reinfusion immediately and contact the anaesthetist concerned and/or the perfusionist and report the incident to Blood Bank.

The usual transfusion observations should be carried out and recorded as per LTHT Policy for Safer Transfusion Procedures.

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16. Disposal of unused donations

Ideally all cell salvaged donated blood should be re-infused to the patient, if it is not re-infused it should be treated as a hazardous substance as blood donated during cell salvage is not routinely screened for viral markers.  All staff should take precautions to protect themselves and others from the risk of virus transmission.

Any unused donated blood must be disposed of in accordance with the LTHT
Standard Infection Control Policy”  
The used, empty blood pack and giving set should also be disposed of in accordance with LTHT policy for the disposal of hazardous waste.

If any cell salvaged donated blood is not re-infused to the patient and is discarded, the reason for this should be clearly documented within the patient’s case notes and reported using Datix web when the non-reinfusion is inappropriate e.g. against local SOP.  The Datix web report must be marked for the attention of Hospital Transfusion Team members.

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17. Documentation of the cell salvage infusion and the fate of the donation / infusion

To comply with the Blood Safety & Quality Regulations (U.K. law 2005) and National Guidelines, ALL stages of the intra or post operative cell salvage process must be carefully documented in the patient’s case notes, including:

• the number of units of blood salvaged
• the total volume of this blood and
• the fate of all donated units, (whether or not they have been re-infused), this should

be done by the person(s) setting up, connecting and/or removing the cell salvage unit.

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18. Reporting adverse events

As for all autologous transfusions, any serious events or adverse reactions should be reported to the Hospital Transfusion Team (HTT) immediately to comply with SHOT and MHRA stipulations and the new U.K. law (2005) Blood Safety and Quality Safety regulations.  This report should be followed up with the completion a Datix web report marked for the attention of HTT members.
The following adverse events should be reported:

• Signs & symptoms of adverse reaction during or post reinfusion of salvaged blood
• Abandoned procedures due to operator error (incorrect assembly, non IV solutions, incorrect anticoagulant, collection time exceeded)
• Abandoned procedures due to machine failure (clotted lines/reservoirs)
• Non-labelling / incorrect labelling of salvaged blood
• Non availability of trained staff precluding the use of cell salvage or which has other impact on the patient

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