COPE OF ACCREDITATION TO IO 15189:2012 PECTRA, EAT LABORATORY 8 King Road Rockleigh, NJ 07647 tylianos Lomvardias, M.D. CLINICAL Valid To: eptember 28, 2018 Certificate Number: 3024.01 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), plasma(p), serum(), sputum(p), terile wabs(), stool(t), urine(), Wounds(W), Whole blood (), and other bodily including PD dialysate fluids(pdf) and Dialysis Fluid(DF): pecialty ub pecialty Test/Analyte Method Matrix Bacteriology Culture detection and Identification Anaerobic Cultures Blood Cultures CF Cultures Fluid Cultures Genital Cultures Respiratory Cultures rine Cultures Wound Cultures ; W; Aspirates; ; Aspirates; fluids C PDF P; ; Aspirates, W, Antimicrobial Drug usceptibility C; P; P; ; ; W; ; Aspirates; rine Colony Count Gram tain C; G; P; ; T; ; W; ; PDF; T; Aspirates; other body Bacteriology cont. ELIA (C. difficile Toxin A & B Antigen) T Microscopic Fecal leukocytes T Wet Mount for Yeast ; Body Fluids; W; ; C; Aspirates Manual (A2LA Cert. No. 3024.01) Revised 06/29/2018 Page 1 of 4
pecialty ub pecialty Test/Analyte Method Matrix Mycology Occult Blood, Fecal Culture detection and Identification Complete ID C; ; W; Aspirates; other body ; Candida albicans C; ; W; Aspirates; other body ; Microscopic KOH Prep T C,, W, Aspirates; General Immunology Ferritin Chemiluminescence Folic Acid Chemiluminescence Homocysteine Chemiluminescence RBC Folate Chemiluminescence Vit B12 Chemiluminescence Vit D, 25 Hydroxy Chemiluminescence PA Chemiluminescence hcg chromatographic HBe Ag EIA ;P HBs Antibody Chemiluminescence ;P HBs Antigen Chemiluminescence ;P HIV Antibody (1/2) Chemiluminescence ;P Rubella IgG Chemiluminescence Measles IgG EIA Therapeutic Drug Monitoring Digoxin Chemiluminescence Phenytoin FPIA Phenytoin, Free FPIA Gentamycin FPIA Phenobarbital FPIA Carbamazepine FPIA Theophylline Chemiluminescence Tobramycin FPIA Vancomycin Chemiluminescence ; P Endocrinology Intact PTH Chemiluminescence P T3 Chemiluminescence T ptake Chemiluminescence T4 Chemiluminescence T4, Free Chemiluminescence TH Chemiluminescence HCG,Total Chemiluminescence (A2LA Cert. No. 3024.01) Revised 06/29/2018 Page 2 of 4
pecialty ub pecialty Test/Analyte Method Matrix Viral Markers yphilis erology Anti-HBc (IgM) Chemiluminescence ;P Anti-HBc (Total) Chemiluminescence ;P Anti-HBe EIA ;P HepA Ab (IgM) Chemiluminescence ;P HepA Ab (Total) Chemiluminescence ;P Hep C Antibody Chemiluminescence ;P RPR Charcoal Flocculation General ALT Kinetic AT Kinetic Albumin Colorimetric Alk Phos Kinetic Amylase Kinetic Bilirubin, Direct Colorimetric Bilirubin, Total Colorimetric BN Enzymatic ;P CO 2 Enzymatic ; PDF; DF Calcium, Ionized IE Calcium Colorimetric ; PDF; DF Chloride IE ; DF Cholesterol Enzymatic CK Kinetic Creatinine Enzymatic ; ; PDF; DF Glucose Enzymatic ; PDF; DF GGT Kinetic Haptoglobin Turbimetric HDL Cholesterol Enzymatic Iron Colorimetric LD Kinetic LDL cholesterol, Enzymatic Direct Lipase Enzymatic Magnesium Colorimetric ; PDF; DF Microalbumin, Quant Turbimetric Phosphorus Colorimetric ; PDF; DF Potassium IE ; DF Protein, Total Colorimetric ; ; PDF; DF odium IE ; DF; PDF Triglycerides Enzymatic IBC Colorimetric rea Nitrogen Enzymatic ; PDF; DF ric Acid Enzymatic pecial Apolipoprotein A-1 Turbidimetric Apolipoprotein B Turbidimetric ß-2 Microglobulin Turbidimetric (A2LA Cert. No. 3024.01) Revised 06/29/2018 Page 3 of 4
pecialty ub pecialty Test/Analyte Method Matrix Trace Elements rinalysis C-Reactive Protein, Wide Range Turbidimetric ; P Prealbumin Turbidimetric Transferrin Turbidimetric Aluminum AA Zinc AA Ketone, Qualitative ph Protein, Qualitative Bilirubin, Qualitative pecific Gravity Chemical Dipstick, Automated rine ediment Microscopy robilinogen Automated Hemoglobin Hematocrit Platelet Count Red Cell Count RBC indices Reticulocyte Count White Cell Count Automated cont. C Differential Fructosamine (Colorimetric) HgbA1c (Colorimetric) Flow Cytometry CHr Manual ER C Differential Coagulation PT/INR aptt Body Fluid Analysis (Peritoneal Dialysis Fluid) Cell Count, Manual White cell Differential Immunohematology Hemagglutination ABO Blood Typing Rh Typing P P PDF; Body Fluid PDF; Body Fluid ; ; (A2LA Cert. No. 3024.01) Revised 06/29/2018 Page 4 of 4
IO 15189:2012 Internationally-Recognized Accredited Laboratory A2LA has accredited PECTRA EAT, INC. Rockleigh, NJ 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). Presented this 12th day of March 2018. President and CEO For the Accreditation Council Certificate Number 3024.01 Valid to eptember 28, 2018 Revised June 29, 2018 For the tests to which this accreditation applies, please refer to the laboratory s Clinical cope of Accreditation.