SPECTRA EAST, INC. Rockleigh, NJ
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1 A2LA has accredited SPECTRA EAST, INC. Rockleigh, NJ for technical competence in the field of Medical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 15189:2007 Medical laboratories - Particular 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 September 2009). Presented this 5th day of February President & CEO For the Accreditation Council Certificate Number Valid to September 30, 2014 Revised June 20, 2014 For the tests or types of tests to which this accreditation applies, please refer to the laboratory s Medical Scope of Accreditation.
2 SCOPE OF ACCREDITATION TO ISO 15189:2007 SPECTRA, EAST LABORATORY 8 King Road Rockleigh, NJ Massoud S. Kashani, M.D. MEDICAL Valid To: September 30, 2014 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: CSF(C), gastric contents(g), 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 Microbiology Bacteriology Culture detection and Identification Anaerobic Cultures SS; W; Blood Cultures ; Aspirates; other fluids CSF Cultures C Fluid Cultures PDF Genital Cultures SS Respiratory Cultures SP; SS; Aspirates Stool Culture ST rine Cultures Wound Cultures Antimicrobial Drug Susceptibility rine Colony Count SS; W; other C; P; SP; SS; ; W; ; (A2LA Cert. No ) Revised 06/20/2014 Page 1 of 5
3 Microbiology Microbiology Bacteriology cont. Gram Stain ELISA (C. difficile Toxin A & B Antigen) Microscopic Fecal leukocytes ST Wet Mount for Yeast C; G; SP; SS; ST; ; W; ; PDF; ST; ST ; Body Fluids; W; SS; C; Aspirates Acid Fast Smear PDF; SP; ; W; SS; Aspirates (to rule out organisms only not used to report patient results) Manual Occult Blood, Fecal Mycology Culture detection and Identification Complete ID C; SS; W; ; Candida albicans C; SS; W; ; Microscopic India Ink C; SS; W; KOH Prep C; SS; W; General Immunology Ferritin Chemiluminescence S Folic Acid Chemiluminescence S Homocysteine Chemiluminescence S ST (A2LA Cert. No ) Revised 06/20/2014 Page 2 of 5
4 General Immunology cont. RBC Folate Chemiluminescence Vit B12 Chemiluminescence S Vit D, 25 Hydroxy Chemiluminescence S PSA Chemiluminescence S hcg chromatographic HBe Ag EIA S; P HBs Anti Chemiluminescence S; P HBs Antigen Chemiluminescence S; P HIV Anti (1/2) Chemiluminescence S; P Rubella IgG Chemiluminescence S Rubeola IgG EIA 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 (A2LA Cert. No ) Revised 06/20/2014 Page 3 of 5
5 General cont. Alk Phos Kinetic S Amylase Kinetic S Bilirubin, Direct Colorimetric S Bilirubin, Total Colorimetric S BN Enzymatic S; P CO 2 Enzymatic S; PDF; DF Calcium, Ionized ISE S Calcium Colorimetric S; PDF; DF Chloride ISE S; DF Cholesterol Enzymatic S CK Kinetic S Creatinine Enzymatic S; ; PDF; DF Glucose Enzymatic S; PDF; DF 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; PDF; DF Microalbumin, Quant Turbimetric Phosphorus Colorimetric S; PDF; DF Potassium ISE S; DF Protein, Total Colorimetric S; ; PDF; DF Sodium ISE S; DF; PDF Triglycerides Enzymatic S IBC Colorimetric S rea Nitrogen Enzymatic ; PDF; DF ric Acid Enzymatic S Special Trace Elements rinalysis 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 Ketone, Qualitative ph (A2LA Cert. No ) Revised 06/20/2014 Page 4 of 5
6 rinalysis cont. 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 C Differential Fructosamine (Colorimetric) HgbA1c (Colorimetric) Flow Cytometry CHr Manual ESR C Differential S Coagulation PT/INR aptt Body Fluid Analysis (Peritoneal Dialysis Fluid) Cell Count, Manual Immunohematology Hemagglutination White cell Differential ABO Blood Typing Rh Typing P P PDF; Body Fluid PDF; Body Fluid ; S ; S (A2LA Cert. No ) Revised 06/20/2014 Page 5 of 5
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