Title: Blood Transfusion Laboratory User Handbook

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Title: Blood Transfusion Laboratory User Handbook No.of copies : 1 Location of copies : 1. Web site 2. Contents Introduction 2 High risk specimens 2 Referred work 2 Location of the laboratory 2 Transportation of specimens 3 Blood Bank Staff and contact details 3 Laboratory Hours 3 Out of hours 3 Patient consent 3 Protection of personal information. 3 Laboratory complaint procedure 4 Receipt of samples 4 Sample validity 5 Check group samples 5 Measurement of Uncertainty 5 Overview flowchart 6 Antenatal Screening Service 7 Blood group and red cell antibody screening (see flow chart below) 7 Report forms 8 Anti-D Prophylaxis 8 Blood Transfusion Risk Management 10 Version : 3.6 Page 1 of 10

Introduction Dear Colleagues, In this handbook you will find basic information concerning the Blood Bank including contact names and telephone numbers. Details of tests performed and other services are given along with the turnaround time for the tests. You may already be in possession of some of these facts and this guide is really a compilation of the appropriate information in one booklet which we hope you will find useful. Although laboratory turnaround times are shown experience has indicated that unexpected delays can occur in the transmission of results. High risk specimens All samples which are regarded as high risk should have both the request form and the specimen labelled with the appropriate high risk sticker. Samples from patients falling into the categories below should be regarded as high risk for the laboratory:- HIV antibody positive. Hepatitis B surface antigen or e antigen positive. Hepatitis C positive. IV drug user Recent jaundice - cause not known. Patients with clinical features of AIDS. Referred work The Blood Bank refers work to the NHSBT Red Cell Immunohaematology Laboratory and Histocompatibility and Immunogenetics Laboratory in Sheffield. The laboratories are UKAS accredited. Services offered by NHSBT Red Cell Immunohaematology can be found here: http://hospital.blood.co.uk/diagnostic-services/red-cell-immunohaematology/ Services offered by NHSBT Histocompatibility and Immunogentics can be found here: http://hospital.blood.co.uk/diagnostic-services/hi/ Specific sample requirements can be sourced from the laboratory protocol Blood Transfusion Referral List, LI-BB-LAB-104, which is available on request. Location of the laboratory The Blood Bank Laboratory is situated on A level (top floor). Following the signs for Pathology and at the T junction near the central lifts go down the corridor opposite the lifts and the Pathology Department is first on the left. Pathology Reception is straight ahead. Version : 3.6 Page 2 of 10

Transportation of specimens Hospital samples are delivered either via the air tube system or by hand to the Pathology Specimen Reception Department. Blood Transfusion requests are given high priority by the Specimen Reception Department the requests are firstly time/date stamped and then sent to the Blood Bank as soon as possible. Blood transfusion samples must be no more than 4 days old when tested. Short, clotted and haemolysed samples may be unsuitable for testing. Antenatal serology samples are usually delivered by hand or transported using Courier Logistics from G.P practices. Blood Bank Staff and contact details Medical Consultant haematologists Consultants (01709) 42 followed by 7419, 4720, 7111,4188 Secretaries (01709) 42 followed by 7112 or 7119 Scientific/Administrative staff Blood Transfusion Manager (01709) 424088 Deputy Blood Bank Manager (01709) 427107 Transfusion Practitioner (01709) 427666 Intergrated Pathology Quality Manager (01709) 424008 HTT Administrator (01709) 424760 / 427666 Laboratory Hours Monday Friday (09:00 17:30 hrs) Saturday Morning (09:00 13:00 hrs) All other times (incl Bank Holidays) Routine Service Routine Service Out of hours service Out of hours The Blood Bank/Haematology Biomedical Scientist on-call can be contacted via telephone number (01709) 424236 or the hospital switchboard (01709) 820000. All out of hours requests must be phoned. The Consultant Haematologists are available via the hospital switchboard and radio pagers ask for the Clinical Haematologist on-call. The Haematologists are available 24/7 to offer clinical advice and interpretation of results. Patient consent Information can be found on the General Laboratory Medicine homepage. Protection of personal information. Information can be found on the General Laboratory Medicine homepage. Version : 3.6 Page 3 of 10

Laboratory complaint procedure Information can be found on the general laboratory medicine homepage. Receipt of samples The labelling requirements for request forms and blood specimens are derived from National Guidelines and the Blood Bank operates a zero tolerance policy in the event of omission, illegibility, error or crossings out the request will not be processed. Request forms and blood specimens once received by the laboratory cannot be amended. Samples and forms for Blood Transfusion / Antenatal Serology / Kleihauer requests must meet minimum labelling requirements that are: Form surname, first name, NHS number (when available), hospital number or A/E number, full date of date of birth, gender, pregnancy status, clinical details, authorised practitioner signature, signature of the person taking the specimen and the date and time. Addressograph labels are permitted. Other information required is the Ward and Consultant. Try and answer all the questions on the form and then indicate what is required, group and save only or issue of blood components. If blood components are required state the quantity and the date and time that they are required to be available and any special requirements e.g. irradiated. Please note that crossmatched blood is only kept on standby for 24 hours from the time that the blood is required. Blood sample (including paediatric) 4.9 mls EDTA (blue top) - must be hand written addressograph labels are not permitted. Details required are surname, first name, hospital number, full date of birth, gender, date and time taken and the signature of the person taking the sample. Unknown male/female admitted to the Accident and Emergency Department require on the sample: hospital number, gender, date and time specimen taken and the initials of the person taking the blood. The form also requires an authorised signature, clinical details and what is required. Test Sample Results Available Adult Group + Antibody X-match tubes 4.9ml - blue 24 hours Screen with or without X- top. Blood specimen must be matching kept warm for CHAD patients. Transfusion reaction investigation Paediatric (< 4months) Kleihauer (FMH) separate request forms are required for mother and baby at delivery X-match tubes 4.9ml - blue top x 4 samples Implicated unit and paperwork returned to laboratory X-match tubes 4.9ml - blue top. Maternal - X-match tube 4.9ml - blue top + EDTA bottle - 4.9ml - red top. Cord - EDTA - bottle - 4.9ml - blue top. Serological investigation - 24 hours 24 hours 72 hours Version : 3.6 Page 4 of 10

DAT Direct Coomb's Test EDTA bottle - up to 4.9ml volume - blue top 24 hours Antenatal serology 4.9ml blue top 72 hours Please refer to Blood Sciences and Micorbiology user Handbooks for sample requirements and turnaround times for tests required for transfusion reaction investigation Sample validity Patients over 4 months old Patients under 4 months old Provided that the patient has not been transfused with red cells or platelets within the last 3 months and if the patient is not pregnant or has not been pregnant within th last 3 months the sample is valid for 7 days. If during this time the patient is transfused with red cells or platelets the sample validity reduces to 72 hours from the time that the transfusion commenced. If a patient has been transfused with red cells or platelets within the last 3 months the sample is only valid for 72 hours. If the patient is currently pregnant or has been pregnant within the last 3 months the sample is only valid for 72 hours. No new sample is required until the patient is 4 months old. However, if the patient has a positive DAT or the mother has atypical red cell antibodies the maternal sample, which is required for crossmatching the baby, will be valid for only 72 hours. Check group samples To conform to current BCSH guidelines for patients requiring blood components, when there is only one blood group on file, a check blood group sample will be required. Until a valid check group sample is received group O Rh D Negative blood will be provided. Please see flow chart on the next page. Measurement of Uncertainty All pathology assays carry an inevitable degree of uncertainty. Whilst many factors are well recognized (pre-analytical variables, analytical precision) some occur by random error alone. (A random error is associated with the fact that when a measurement is repeated it will generally provide a measured value that is different from the previous value. It is random in that the next measured value cannot be predicted exactly from previous such values). Users should bear in mind these uncertainties when interpreting any laboratory value. The laboratory is happy to discuss analytical variation with any user of the service. Laboratory EQAS performance data is available to any interested user please contact the laboratory Manager. Version : 3.6 Page 5 of 10

Overview flowchart A check group sample is only required when the first time patient sample is still valid i.e. there is no transfusion history for the patient. Valid sample received, processed & authorised Result issued on ICE with the comment: In the event that blood components are required a check blood group sample will be requested by the Blood Bank provided this sample is still valid 09.00-17.25 Blood components required Weekend + Out of hours Blood Bank MLA will deliver a specially labelled Blood Transfusion request form and sample tube to clinical area Specially labelled Transfusion request form and sample tube will be available for collection in the blood collection room or sent via ait tube system to the ward Valid Blood Transfusion request form and sample for check group received, processed & authorised Blood components issued Urgent requirement for blood: The Check Group sample procedure should not interfere with the urgent delivery of blood and has been introduced to help prevent ABO incompatible blood transfusions. With this in mind Group O Rh D Negative* blood will be issued until the patient group has been confirmed. In the event of major bleed please activate the Massive Haemorrhage Procedure by contacting switchboard on 2222 *In some instances Group O Rh D Positive blood may be issued to male patients. Version : 3.6 Page 6 of 10

Antenatal Screening Service Antenatal serology screening involves blood group determination and identification of atypical antibodies associated with haemolytic disease of the newborn and Microbiology screening see flow chart. A separate Microbiology request form and sample (4.9ml brown top blood) is required for further information regarding microbiology screening of antenatal patients refer to the Microbiology Handbook. Blood group and red cell antibody screening (see flow chart below) These tests are performed twice during each pregnancy, once at booking (6-16 weeks) and again at 28 weeks. Samples on patients who have developed significant red blood cell antibodies may be required more often than usual, the frequency of which will be indicated on the antenatal report along with the number of blood samples required. The samples are required to monitor the strength (titre) of the antibody(ies) concerned and to identify pregnancies which may be at risk from Haemolytic Disease of the Newborn (HDN). The samples also monitor the possible formation of additional allo-antibodies during the pregnancy. Patients who have developed red cell antibodies should be referred to an Obstetrician. The current guidelines state that women with anti-c, D, K or K related antibodies require repeat samples every 4 weeks until the 28th week of pregnancy and thereafter every 2 weeks until delivery. Other specificities commonly implicated as causing HDN include anti-c, E, Fy(a) and Jk(a) though there are many other rarer antibodies. Guidelines recommend testing these patients at booking and at 28 weeks of pregnancy only although further testing will be performed as required. Anti-Le(a), Le(b), N, Lu(a), P1, H and A1 are not considered to be clinically significant with respect to HDN. When the mother develops a significant red blood cell antibody a paternal sample may be requested. This is to determine the father s phenotype and predict the likelihood of the foetus carrying the relevant red cell antigen which may indicate whether there is the possibility of HDN. The red blood cell membrane contains numerous antigenic molecules which may induce the production of plasma antibodies. Currently there are more than 600 known red cell antigens. Immunisation is caused by exposure to 'foreign' red cells via pregnancy or transfusion although some plasma antibodies are naturally occurring. The following table shows important antibodies that are encountered : Blood Group System Antibody Causes Transfusion Reaction? Causes HDN? % Blood Compatible Rhesus Anti-c Probable Common 20 Rhesus Anti-C Probable Possible 32 Rhesus Anti-C w Probable Possible 98 Rhesus Anti-D Probable Common 15 Rhesus Anti-e Probable Possible 2 Version : 3.6 Page 7 of 10

Rhesus Anti-E Probable Possible 71 Kell Anti-k (Cellano) Probable Possible 0.2 Kell Anti-K Probable Possible 91 Kell Anti-Kp a Probable Possible 98 Duffy Anti-Fy a Probable Possible 34 Duffy Anti-Fy b Probable Possible 17 Kidd Anti-Jk a Probable Possible 23 Kidd Anti-Jk b Probable Possible 26 Lewis Anti-Le a Rare Unlikely 78 Lewis Anti-Le b Unlikely Unlikely 28 MNS Anti-M Unlikely Unlikely 22 MNS Anti-N Unlikely Unlikely 28 MNS Anti-s Probable Possible 11 MNS Anti-S Probable Possible 45 MNS Anti-U Probable Possible <0.1 P Anti-P1 Unlikely Unlikely 21 Lutheran Anti-Lu a Unlikely Unlikely 92 Lutheran Anti-Lu b Probable Possible <0.2 Report forms Please note that separate red cell and microbiology reports will be issued. Anti-D Prophylaxis To help prevent Rhesus D haemolytic disease of the newborn injections of prophylactic anti-d are administered to Rhesus D negative women either prophylactically at 28-30 weeks of pregnancy or following a possible sensitising event. The Blood Bank holds stocks 1500 IU/ml prophylactic anti-d (standard dose) that is stored in a controlled environment of 4 o C. The dose of routine prophylactic anti-d (RAADP) given between 28 and 30 weeks of pregnancy is 1500iu/ml The dose of anti-d required following a possible sensitising event is determined according to the protocol LP-BB-LAB-038 Prevention of HDNB due to anti-d including FMH testing using the BD Canto II Flowcytometer. A Flow Chart for blood grouping and antibody testing during pregnancy is shown on the page below: Version : 3.6 Page 8 of 10

Antenatal Serology flow chart From 8 weeks (booking) Test ABO & Rhesus D & antibody Clinically significant antibodies No antibodies Paternal genotype (if not already done) Test monthly if anti-d, anti-c or anti-kell /Kell related antibodies 28 weeks All pregnant women Test AB O and Rhesus D Group and Antibody screen Clinically significant antibodies No antibodies Test at least 2 weekly if anti-d, anti-c and anti- Kell / Kell related antibodies Delivery Test maternal ABO, RhD group and antibody screen. Test infant ABO, RhD group and DAT. Monitor infant for HDN Kleihauer samples if mother RhD negative Current guidelines used in Antenatal Serology and prevention of HDN : BCSH - Guideline for Blood Grouping and Red Cell Antibody testing in Pregnancy (2016) BCSH - Guidelines for the use of prophylactic anti-d immunoglobulin NICE - Routine antenatal anti-d prophylaxis for women who are rhesus D negative NICE - Routine care for the healthy pregnant woman Version : 3.6 Page 9 of 10

Blood Transfusion Risk Management When an incident is reported the following must be undertaken: Full details of all incidents must be passed to the Transfusion Practitioner. The Transfusion Practitioner and/or other Hospital Transfusion Team (HTT) members as appropriate will investigate the incident. The HTT are responsible for informing SABRE and/or SHOT of any reportable incident via the online reporting system. Incidents must be investigated as soon as possible and: Appropriate corrective action taken. Where required, further preventative measures implemented. Fed back to all relevant staff. If the adverse event is an externally reportable incident the member of staff involved must be removed from all aspects of the transfusion procedure. Following full investigation of the incident the staff member(s) involved will receive appropriate training and competency assessment. The timeframe for reinstatement of a member of staff into the transfusion chain will be determined by the HTT following full deliberation of all the information and circumstances surrounding the incident. The HTT will review all incidents, and consider any changes that may be required to existing policies and procedures. Any changes must be communicated to the appropriate professionals in order to ensure compliance to these changes. For Laboratory staff this would be via the Q-Pulse document control system. All incidents are reported to the Trust Patient Safety Group Version : 3.6 Page 10 of 10