Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK East and North Hertfordshire NHS Trust Issue No: 007 Issue date: 09 September 2021 Lister Hospital Contact: Laarni Calonzo Coreys Mill Lane Tel: +44 (0)1438 285225 8846 Stevenage E-Mail: [email protected] Hertfordshire Website: www.enherts-tr.nhs.uk Accredited to SG1 4AB ISO 15189:2012 Testing performed at the above address only Site activities performed away from the locations listed above: Location details Activity Ambulatory Care Blood storage & issue QE2 Hospital Fridge managed by Haematology Howlands Welwyn Garden City Hertfordshire AL7 4HQ Blood Transfusion Department Blood storage & issue Lister Hospital Fridge managed by Haematology Coreys Mill Lane Stevenage Hertfordshire SG1 4AB Hertford Hospital Local contact Phlebotomy services North Road Hertford Elaine Stokes SG14 1LP Lister Hospital Local contact Phlebotomy services Coreys Mill Lane Stevenage Elaine Stokes Hertfordshire SG1 4AB QE2 Hospital Local contact Phlebotomy services Howlands Welwyn Garden City Elaine Stokes Hertfordshire AL7 4HQ Assessment Manager: JG4 Page 1 of 24 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK East and North Hertfordshire NHS Trust 8846 Issue No: 007 Issue date: 09 September 2021 Accredited to ISO 15189:2012 Testing performed at main address only DETAIL OF ACCREDITATION Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN BODY FLUIDS Blood Transfusion examinations to Procedures documented in assist in clinical investigations manufacturer’s equipment manuals in conjunction with documented in- house procedures by the following methods: Blood Antibody Identification by detection Automated using Grifols Gel Plasma of antibodies to: Column Technology DG Gel Coombs Cards, Rh –C,D,E,c,e, Cw SOP BTSOP1822 (The use of Kell –K, K, Kpa Grifols Erytra [manual interpretation Duffy –Fya, Fyb of results] MNSs- M, N, S, s SOP BTSOP1827 (Antibody Kidd –JKa, Jkb Identification [manual interpretation of results Blood Antibody Identification by detection Manual using Grifols DG Gel Plasma of antibodies to: Coombs Cards SOP BTSOP1829 (Grifols Manual Rh –C,D,E,c,e, Cw Techniques Kell –K, K, Kpa Duffy –Fya, Fyb MNSs- M, N, S, s Kidd –JKa, Jkb Blood Blood Group by detection and Automated using Grifols Gel identification of antigens: Column Technology SOP BTSOP 1822 (The use of the A Rh D Positive Grifols Erytra AB Rh D Positive B Rh D Positive O Rh D Positive A Rh Negative AB Rh D Negative B RhD Negative O Rh D Negative Including the presence of A2 antigens Assessment Manager: JG4 Page 2 of 24 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK East and North Hertfordshire NHS Trust 8846 Issue No: 007 Issue date: 09 September 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN BODY FLUIDS (cont’d) Blood Transfusion examinations to Procedures documented in assist in clinical investigations manufacturer’s equipment manuals (cont’d) in conjunction with documented in- house procedures by the following methods: Blood Blood Group by detection and Manual using Grifols DG Gel identification of antigens: ABO/Rh (2D + Kell Cards A Rh D Positive SOP BTSOP 1829 (Grifols Manual AB Rh D Positive Techniques) B Rh D Positive Manual tube techniques using O Rh D Positive Lorne Antisera for possible A Rh Negative subgroups of A using SOP AB Rh D Negative BTSOP1708 (Sub groups of A with B RhD Negative anti-A1) O Rh D Negative Including the presence of A2 antigens Blood Antibody Screen by detection of Automated using Grifols Gel Plasma antibodies to: Column Technology SOP BTSOP 1822 Rh –C,D,E,c,e, Cw Kell –K, K, Kpa Duffy –Fya, Fyb MNSs- M, N, S, s Kidd –JKa, Jkb Blood Antibody Screen by detection of Manual using Grifols DG Gel Plasma antibodies to: Coombs Cards SOP BTSOP1829 (Grifols Manual Rh –C,D,E,c,e, Cw Techniques) Kell –K, K, Kpa Duffy –Fya, Fyb MNSs- M, N, S, s Kidd –JKa, Jkb Blood Compatibility testing of patients Cross matching using manual Plasma plasma with donor cells indirect anti globulin test using Grifols Gel column technology and SOP BTSOP 1830 Blood Compatibility testing of patients Cross matching using Grifols Plasma plasma with donor cells serological tesing using SOP BTSOP1822 Assessment Manager: JG4 Page 3 of 24 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK East and North Hertfordshire NHS Trust 8846 Issue No: 007 Issue date: 09 September 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN BODY FLUIDS (cont’d) Blood Transfusion examinations to Procedures documented in assist in clinical investigations (cont’d) manufacturer’s equipment manuals in conjunction with documented in- house procedures by the following methods: Blood Compatibility testing of patients Electronic cross match using Plasma plasma with donor cells BTSOP 1510 Blood Direct Antiglobulin Test (DAT) Automated using Grifols Gel Plasma Column technology SOP BTSOP 1822 (The use of the Grifols Erytra) Blood Foetal Maternal Haemorrhage Manual Kleihauer Acid Elution Plasma Technique using SOP BTSOP 1707 Blood Red cell phenotyping for Rh and Automated using Grifols Gel Plasma Kell antigens Column Technology SOP BTSOP 1822 (The use of Grifols Erytra) SOP BTSOP 1825 (Red Cell Phenotyping Blood Red Cell phenotyping for RBC Manual using Grifols DG Gel Plasma antigens other than Rh and Kell Coombs Cards and manual tube methods using Lorne Antisera; SOP BTSOP 1825 (Red Cell Phenotyping) Haematological examinations for Procedures documented in the purpose of clinical diagnosis manufacturer’s equipment manuals in conjunction with documented in- house procedures by the following methods: Blood Adult Haemoglobinopathy analysis Documented In-House Methods to (including Antenatal) by detection of meet the requirements of the SCT haemoglobin variants: screening programme as defined in the July 2018 sickle cell and HbA1c thalassaemia screening: laboratory Hb A2 QA evidence requirements Hb F Menarini HA8180 HPLC using SOP BSLSOPHAEM24 (Procedure on the Use of Menarini HA-8180) BSLSOPHAEM25 (Haemoglobinopathy Screening (ANEP)) Assessment Manager: JG4 Page 4 of 24 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK East and North Hertfordshire NHS Trust 8846 Issue No: 007 Issue date: 09 September 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN BODY FLUIDS (cont’d) Haematological examinations for Procedures documented in the purpose of clinical diagnosis manufacturer’s equipment manuals (cont’d) in conjunction with documented in- house procedures by the following methods: Blood Erythrocyte Sedimentation Rate Red blood cell sedimentation rate (ESR) using sediplus s2000 analyser and M2000 mixer and SOP BSL SOP HAEM7 Blood Blood / Bone marrow film analysis Manual Romanowsky stain using Bone marrow in order to identify or exclude SOP BSLSOPHAEM 4 Perl’s Morphological and Cytological Prussian blue reaction using SOP abnormalities for the purpose of BSLSOPHAEM6 diagnosis Blood Blood film analysis, Detection of Automated slide and stain maker normal and abnormal blood cell (Sysmex SP-10) which methanol morphology and manual differential fixes and stains films by Romanowsky method SOP BSLSOPHAEM 33, 3, 4 and 5. Blood FBC and reticulocyte count: Sysmex XN cytometry and spectrophotometry using SOP WB BSLSOPHAEM31 and Differential Hb BSLSOPHAEM32 Platelets RBC MCV MCH MCHC Hct nRBC Blood G6PD qualitative screen Manual fluorescence technique using the Trinity Biotech Kit 203-A BSLSOPHAEM18 Blood Detection of IM Hetrophile Manual antibody-antigen latex antibodies-Glandular Fever Screen agglutination using the Monogen Biokit, for IM Hetrophile antibodies. BSLSOPHAEM17 Assessment Manager: JG4 Page 5 of 24 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK East and North Hertfordshire NHS Trust 8846 Issue No: 007 Issue date: 09 September 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN BODY FLUIDS (cont’d) Haematological examinations for Procedures documented in the purpose of clinical diagnosis manufacturer’s equipment manuals (cont’d) in conjunction with documented in- house procedures by the following methods: Blood Partial detection & speciation of Preparation of thin films, manual malaria parasites: Giemsa staining and light microscopy using SOP BSLSOPHAEM8 Blood Malarial antigens of: Optimal IT rapid malaria screen Immunochromatographic test using Plasmodium falciparum SOP BSLSOPHAEM9 and pan-detection for: Plasmodium malariae,