ISO 15189:2012 Internationally-Recognized Accredited Laboratory. SPECTRA EAST, INC. Rockleigh, NJ

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1 ISO 15189:2012 Internationally-Recognized Accredited Laboratory A2LA has accredited SPECTRA EAST, INC. Rockleigh, NJ for technical competence in the field of Clinical Testing This laboratory is accredited in accordance with the recognized International Standard ISO 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 ISO-ILAC-IAF Communiqué dated January 2015). Presented this 21 st day of November Senior Director of Quality and Communications For the Accreditation Council Certificate Number Valid to October 31, 2016 Revised: September 27, 2016 For the tests to which this accreditation applies, please refer to the laboratory s Clinical Scope of Accreditation.

2 SCOPE OF ACCREDITATION TO ISO 15189:2012 SPECTRA, EAST LABORATORY 8 King Road Rockleigh, NJ Massoud S. Kashani, M.D. CLINICAL Valid To: October 31, 2016 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: plasma(p), serum(s), sputum(sp), Sterile Swabs(SS), stool(st), urine(), wounds(w), whole blood (), and other bodily including PD dialysate fluids(pdf) and dialysis fluid(df): Specialty Sub Specialty Test/Analyte Method Matrix Bacteriology Culture Detection and Identification Anaerobic Cultures Blood Cultures Fluid Cultures Genital Cultures Respiratory Cultures Stool Culture rine Cultures Wound Cultures SS; W; ; PDF; PDF; fluids SS SP; SS; Aspirates ST SS; W; other Antimicrobial Drug Susceptibility SP; SS; ST; ; W; ; (A2LA Cert. No ) Revised 09/27/2016 Page 1 of 6

3 Bacteriology cont. rine Colony Count Gram Stain SP; SS; ST; ; W; ; PDF; ELISA (C. difficile Toxin A & B Antigen) ST Microscopic Fecal Leukocytes ST Wet Mount for Yeast ; Body Fluids; W; SS; Aspirates Manual Occult Blood, Fecal ST Mycology Culture Detection and Identification Complete ID SS; W; ; Candida albicans SS; W; ; Microscopic KOH Prep SS; W; General Immunology Ferritin Chemiluminescence S Folic Acid Chemiluminescence S Homocysteine Chemiluminescence S RBC Folate Chemiluminescence Vit B12 Chemiluminescence S Vit D, 25 Hydroxy Chemiluminescence S PSA Chemiluminescence S hcg chromatographic HBe Ag EIA S; P (A2LA Cert. No ) Revised 09/27/2016 Page 2 of 6

4 General Immunology cont. HBs Anti Chemiluminescence S; P HBs Antigen Chemiluminescence S; P HIV Anti (1/2) Chemiluminescence S; P Rubella IgG Chemiluminescence S Measles IgG Chemiluminescence S Therapeutic Drug Monitoring Digoxin Chemiluminescence S Phenytoin FPIA S Phenytoin, Free FPIA S Gentamycin FPIA S Phenobarbital FPIA S Carbamazepine FPIA S Theophylline Chemiluminescence S Tobramycin FPIA S Vancomycin Chemiluminescence S; P Endocrinology Intact PTH Chemiluminescence P T3 Chemiluminescence S T ptake Chemiluminescence S T4 Chemiluminescence S T4, Free Chemiluminescence S TSH Chemiluminescence S HCG,Total Chemiluminescence S Viral Markers Anti-HBc (IgM) Chemiluminescence S; P Anti-HBc (Total) Chemiluminescence S; P Anti-HBe EIA S; P HepA Ab (IgM) Chemiluminescence S; P HepA Ab (Total) Chemiluminescence S; P Hep C Anti Chemiluminescence S; P Syphilis Serology RPR Charcoal Flocculation S General ALT Kinetic S AST Kinetic S Albumin Colorimetric S Alk Phos Kinetic S (A2LA Cert. No ) Revised 09/27/2016 Page 3 of 6

5 General cont. Amylase Kinetic S Bilirubin, Direct Colorimetric S Bilirubin, Total Colorimetric S BN Enzymatic S; P CO 2 Enzymatic S; DF Calcium, Ionized ISE S Calcium Colorimetric S; DF; Chloride ISE S; DF; Cholesterol Enzymatic S CK Kinetic S Creatinine Enzymatic S; ; PDF; DF Glucose Enzymatic S; PDF GGT Kinetic S Haptoglobin Turbimetric S HDL Cholesterol Enzymatic S Iron Colorimetric S LD Kinetic S LDL Cholesterol, Enzymatic S Direct Lipase Enzymatic S Magnesium Colorimetric S; DF Microalbumin, Quant Turbimetric Phosphorus Colorimetric S; DF Potassium ISE S; DF; Protein, Total Colorimetric S; ; DF Sodium ISE S; DF; PDF; Triglycerides Enzymatic S IBC Colorimetric S rea Nitrogen Enzymatic ; PDF; DF ric Acid Enzymatic S Special Trace Elements Apolipoprotein A-1 Turbidimetric S Apolipoprotein B Turbidimetric S ß-2 Microglobulin Turbidimetric S C-Reactive Protein, Turbidimetric S; P Wide Range Prealbumin Turbidimetric S Transferrin Turbidimetric S Aluminum AA S Zinc AA S (A2LA Cert. No ) Revised 09/27/2016 Page 4 of 6

6 rinalysis Ketone, Qualitative ph Protein, Qualitative Bilirubin, Qualitative Specific Gravity Chemical Dipstick, Automated rine Sediment Microscopy robilinogen Automated Hemoglobin Hematocrit Platelet Count Red Cell Count RBC Indices Reticulocyte Count White Cell Count Flow Cytometry C Differential Fructosamine (Colorimetric) HgbA1c (Colorimetric) CHr Manual ESR C Differential Coagulation PT/INR aptt Body Fluid Analysis (Peritoneal Dialysis Fluid) Cell Count, Manual White Cell Differential S P P PDF; Body Fluid PDF; Body Fluid (A2LA Cert. No ) Revised 09/27/2016 Page 5 of 6

7 Immunohematology Hemagglutination ABO Blood Typing Rh Typing ; S ; S (A2LA Cert. No ) Revised 09/27/2016 Page 6 of 6