SCOPE OF ACCREDITATION ISO 15189:2012. SPECTRA LABORATORY, INC. 525 Sycamore Drive Milpitas, CA Claude O. Burdick, M.D.
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1 COE OF ACCREDITATION IO 15189:2012 ECTRA LABORATORY, INC. 525 ycamore Drive Milpitas, CA Claude O. Burdick, M.D. CLINICAL Valid To: December 31, 2017 Certificate Number: In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following types of testing on human samples, including: CF (C), Gastric Contents (G), lasma (), erum (), putum (), terile wabs (), tool (T), rine (), Wounds (W), Whole blood (), and other bodily /tissues including D Dialysate Fluids (DF) and Dialysis Fluid (DF). ub General ALT Kinetic AT Kinetic Albumin BCG Alk hos N/AM Amylase Chromogenic Blocked p-nitrophyl substrate ß-2 Microglobulin Turbimetric Bilirubin, Direct DD Diazonium alt Bilirubin, Total DD Diazonium alt CO 2 Enzymatic ; DF; DF; Calcium Arsenazo ; DF; DF; Calcium, ionized IE Chloride IE ; DF; DF; Cholesterol /Enzymatic cldl Calculation CK Creatinine phospate/nad Creatinine Alkaline icrate - Jaffe Kinetic Rate ; ; DF; DF; WR C-reactive protein, quantitative (incl. hscr and CR) Immunoturbidimetric (A2LA Cert. No ) Revised 08/09/2016 age 1 of 5
2 ub General cont. GGT L-g-glutanyl-3-carboxy-4-nitroanalyte/ glycoglycine Glomerular filtration EI rate Glucose Hexokinase DF; DF; HDL cholesterol Enzymatic/Homogenous-Immuno Inhibition Iron /Tripyridyltriazine w/o R Iron at Calculation LDH Lactate to yruvate LDL Cholesterol Enzymatic/Homogenous Immuno Inhibition Lipase Enzymatic/ Magnesium /Xylidyl Blue/Mago ; DF; Microalbumin, Immunoturbidimetric quantitative hosphorus /hospormolybdate-no reduction otassium IE ; DF; realbumin Immunoturbidimetric rotein yrogallol red ; DF rotein, total Biuret odium IE ; DF; DF; Transferrin pectrophotometry/immunoturbidimetric Triglycerides Enzymatic IBC rea Enzymatic DF; ; ric acid rine Albumin/ Creatine Ratio Calculation pecial Aluminum IC-M Cyclosporine Enzyme Immunoassay Fructosamine ; Glomerular filtration EI rate Hemoglobin A1C Colorimetry/Turbidimetry/IFCC Zinc IC-M (A2LA Cert. No ) Revised 08/09/2016 age 2 of 5
3 ub Therapeutic Drug Monitoring Carbamazepine FIA Digoxin Chemiluminescence Gentamicin FIA henobarbital FIA henytoin FIA henytoin, free FIA Valproic acid Chemiluminescence Vancomycin Chemiluminescence rinalysis pecific gravity rinalysis dipstick, automated rinalysis dipstick, manual rinalysis automated imaging systems rine Microscopy Automated rine sediment microscopy (including crystal ID) robilinogen Automated Eosinophil count Hematocrit Hemoglobin latelet count (LT) RBC count RBC indices (e.g. MCV, RDW) Reticulocytes - automated C Count C Differential ER CHR Manual Blood film (C differential, RBC morphology) Manual Body Fluid Analysis Body Fluid cell count, manual Body Fluid differential Body Fluid cell count, automated (A2LA Cert. No ) Revised 08/09/2016 age 3 of 5 Body Fluids Body Fluids Body Fluids
4 Immunology ub Coagulation INR Electromechanical T Electromechanical TT Electromechanical General Immunology BN Chemiluminescence Ferritin Chemiluminescence Folate Chemiluminescence HAV antibody, IgM Chemiluminescence HAV antibody, total Chemiluminescence HBc antibody, IgM, Chemiluminescence EIA HBc antibody, total, Chemiluminescence HBs antibody, Chemiluminescence HBsAg Chemiluminescence hcg, with Chemiluminescence qualitative interpretation HCV antibody Chemiluminescence HIV-1/2 antibody, Chemiluminescence immunoassay Homocysteine Chemiluminescence arathyroid Chemiluminescence hormone (TH), intact rostate specific Chemiluminescence antigen (A) RR Cardiolipin-Flocculation Rubella antibody, Chemiluminescence quantitative Treponema Chemiluminescence allidum (yphilis antibodies) T3, free Chemiluminescence T3, total Chemiluminescence T3, uptake Chemiluminescence T4, free Chemiluminescence T4, total Chemiluminescence TH ltra Chemiluminescence Vitamin B12 Chemiluminescence Vitamin D, 25- Chemiluminescence hydroxy Vitamin D, 1, 25- dihydroxy Chemiluminescence (A2LA Cert. No ) Revised 08/09/2016 age 4 of 5
5 ub Microbiology Bacteriology Antimicrobial Turbidimetric/Disk Diffusion susceptibility, urine Antimicrobial Turbidimetric/Disk Diffusion ; ; T; susceptibility, other W; ; DF Bacterial identification, throat Bacterial identification, urine Genital Cultures Culture ID Occult blood, fecal Hemoccult cards T rine Colony Count Manual Microbiology Culture detection and Identification Anaerobic Cultures ; W; ; DF; other body Bacterial Culture, Complete ID Bacterial Culture, artial ID ; ; ; T; W; ; DF; other body ; ; ; T; W; ; DF; other body Blood Cultures Genital Cultures Respiratory Cultures ; tool Culture T rine Cultures Wound Cultures ; W DF Cultures DF Fluid, Other Cultures Microbiology Molecular Microbiology Hepatitis C viral load Hepatitis B viral load CR CR Other body (A2LA Cert. No ) Revised 08/09/2016 age 5 of 5
6 IO 15189:2012 Internationally-Recognized Accredited Laboratory A2LA has accredited ECTRA LABORATORIE, INC. Milpitas, CA for technical competence in the field of Clinical This laboratory is accredited in accordance with the recognized International tandard IO 15189:2012 Medical laboratories - Requirements for quality and competence. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint IO-ILAC-IAF Communiqué dated January 2015). resented this 15 th day of December enior Director of Quality and Communications For the Accreditation Council Certificate Number Valid to December 31, 2017 Revised: August 9, 2016 please For the tests to which this accreditation applies, refer to the laboratory s Clinical cope of Accreditation.
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