Department: Testing Laboratory-Medical Name and Address: Organization name Address Phone Fax E-Mail ISO 15189 Accreditation No. 0195 Appendix to certificate No. Dor Yeshorim Hamarpe St. No. 5, Har Hozvim, Jerusalem 91057 Israel +972-2-6499890 +972-2-6499891 dvoraha@cc.huji.ac.il As declared by the organization, following is a list of the permanent sites and the phones numbers at which accredited activities are preformed. P Main: Har Hozvim P1 Shadar Definitions: +972-2-6499890 Main site: A central site where the quality system is controlled for all sites where tests, calibrations or sampling are preformed. Permanent site (Branch): Permanent or temporary site existing longer than 6 months where at, or from which, the activities part of the accreditation schedule are preformed. The certificate attached is an integral part of the schedule and is numbered identically התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח Date of issue 13.03.2013 Version No. 1 Page No. 1 of: 3 0195-03 Department Testing Laboratory-Medical ISO 15189 Accreditation No. 0195 Appendix to certificate No. 0195-03 Schedule of Accreditation Ite m Scope Type Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station Opinion and Interpretation Remarks נוזלי גוף ורקמות מגוף האדם: נוזלי גוף ורקמות מגוף האדם משפחת מוצרים:משפחת מוצרים Group of products: Human Body fluids and Tissues Medicine – Genetics diagnosis, Screening testing, Confirmation and characterization Hereditary disease PCR-based Molecular methods אישור ואפיון למחלות תורשתיות, בדיקות סריקה,רפואה – גנטיקה PCR שיטות מולקולריות מבוססות kits: Invisiorb, MagNA Pure96, Qiagen --- DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- Cystic Fibrosis DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- Familial Dysautonomia Familial Dysautonomia DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- P Fanconi anemia C Fanconi anemia C DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 7 A P Gaucher disease Gaucher disease DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 8 A P Glycogen storage disease AI Glycogen storage disease AI DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 9 A P ML4 disease ML4 disease DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 10 A P Nemaline myopathy Nemaline myopathy DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 11 A P Niemman Pick disease Niemman Pick disease DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 12 A P Tay Sachs disease Tay Sachs disease DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 13 A P Usher syndrome la Usher syndrome la DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 1 A P DNA purification DNA purification Blood cells 2 A P Bloom syndrome Bloom syndrome DNA 3 A P Canavan disease Canavan disease 4 A P Cystic Fibrosis 5 A P 6 A תאי דםDNA purification Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request. Date of issue 13.03.2013 Version No. 1 Page No. 2 of: 3 The certificate attached is an integral part of the schedule and is numbered identically התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח Department Testing Laboratory-Medical ISO 15189 Accreditation No. 0195 Appendix to certificate No. 0195-03 Schedule of Accreditation Ite m Scope Type 14 A Site P Types of Test / Properties Measured Materials / Samples Tested Non syndromic hearing loss (GJB2, GJB6, LOXHD1) Non syndromic hearing loss (GJB2, GJB6, LOXHD1) DNA Test principle / Characteristics Equipment used / Work station Opinion and Interpretation DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 15 A P Maple syrup Urine Disease Maple syrup Urine Disease DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 16 A P Lipoamide dehydrogenase Deficinency Lipoamide dehydrogenase Deficinency DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 17 A P Hyperinsulinemia Hyperinsulinemia DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 18 A P Joubert syndrome2 Joubert syndrome2 DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 19 A P Walker-Warbourg syndrome Walker-Warbourg syndrome DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 20 A P Bardet-Biedl type 2 syndrome Bardet-Biedl type 2 syndrome DNA DNA ASP (Allele Specific PCR) PCR cycler Electrophoresis running tank Imaging system --- 21 A P1 Phlebotomy - Adult Phlebotomy - Adult Whole blood דם מלא הוצאת דם ורידי למבוגרים בלבד --- Remarks --- Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request. Date of issue 13.03.2013 Version No. 1 Page No. 3 of: 3 The certificate attached is an integral part of the schedule and is numbered identically התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח