Specialty Sub Specialty Test/Analyte Method Matrix · LABORATORY CORPORATION OF AMERICA 69 First...
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Transcript of Specialty Sub Specialty Test/Analyte Method Matrix · LABORATORY CORPORATION OF AMERICA 69 First...
(A2LA Cert. No. 4119.01) 01/18/2018 Page 1 of 18
SCOPE OF ACCREDITATION TO ISO 15189:2012
LABORATORY CORPORATION OF AMERICA 69 First Avenue
Raritan, NJ 08869 Dr. Araceli Reyes 908 526 2400 Ext. 2117
CLINICAL Valid To: January 31, 2021 Certificate Number: 4119.01
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: Plasma (P), Serum (S), Sputum (SP), Sterile Swabs (SS), Stool (ST), Urine (U), Wounds (W), Whole Blood (WB), Semen, Pathology Tissue, Nasal Fluid, Heparin, Blood Smear and other bodily fluids/tissues including Dried Blood Spot/Dried Serum Spot (DBS).
Specialty Sub Specialty Test/Analyte Method Matrix
Pathology Histopathology Routine Processing Manual, Microscopy Pathology
Tissue Gross Evaluation, Non-
Pathologist Manual, Microscopy Pathology
Tissue Gross Evaluation,
Pathologist Manual, Microscopy Pathology
Tissue Immunofluorescence
Stain, Tissue Biopsy Staining, Microscopy Pathology
Tissue Immunohistochemistry
Staining IHC, Microscopy Pathology
Tissue Microscopic Evaluation,
Surgical Pathology Microscopy Pathology
Tissue Oral Pathology (Oral
Specimen Exam) Microscopy Pathology
Tissue Pathologist
Interpretation, FNA Microscopy Body Fluid
Skin Scrapings for Parasites, Surgical Pathology
Microscopy Pathology Tissue
Special Stains – Histochemistry
Staining, Microscopy Pathology Tissue
(A2LA Cert. No. 4119.01) 01/18/2018 Page 2 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Pathology Cytology Automated PAP
Screening / Re–Screening
Microscopy
BF
FNA Accessioned & Processed in Cytology
Microscopy
BF
Interpretation, FNA Microscopy BF
Interpretation, Non-Gyn Cytology
Microscopy
BF
Liquid Based Preparation
Microscopy
BF
Pathologist Interpretation, Gynecologic Cytology, FNA, Non-Gyn Cytology
Microscopy
BF / Tissue
Screening by Cytotech, Gynecologic Cytology
Microscopy
BF
Screening by Cytotech, Non-Gynecologic Cytology
Microscopy
BF
Chemistry General Chemistry Albumin Colorimetric– Bromcresol S or P Alk Phos Enzymatic– Colorimetric S or P ALT Enzymatic– Colorimetric S or P Ammonia Enzymatic EDTA Amylase Enzymatic–Colorimetric S or P AST Enzymatic–Colorimetric S or P Bilirubin, Direct Colorimetric– Diazo S or Heparin Bilirubin, Direct
(Neonatal)Colorimetric– Diazo S or Heparin
Bilirubin, Total Colorimetric– Diazo S or Heparin Calcium NM–BAPTA Photometric S or Heparin,
Urine, BF Calcium, Ionized Ion Selective Electrode Serum Chloride ISE S or Heparin,
U
(A2LA Cert. No. 4119.01) 01/18/2018 Page 3 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Chemistry General Chemistry Cont. Cholesterol Enzymatic– Colorimetric S or EDTA CK–MB ECLIA S CO2 Colorimetric (PEPC) S or Heparin C-Reactive Protein,
QuantitativeImmuno–Turbidimetric S or EDTA
Creatine Kinase (CK) Enzymatic– Colorimetric S or Heparin Creatinine JAFFE–Picrate, Rate S or EDTA,
BF, U Cryoglobulin Manual S
Fetal Fibronectin Immunoassay Cervicovaginal Fluid
G–6–PD Screen Kinetic WB GGT Enzymatic–Colorimetric S or EDTA Glucose Enzymatic Glucose
Endpoint–Hexokinase S or P Gray, BF, U
Beta Hcg, Quantitative ECLIA S HDL Cholesterol Enzymatic– Colorimetric S or EDTA Iron Colorimetric– Ferrozine S LD Enzymatic– Colorimetric S or EDTA LDL Cholesterol, Direct Enzymatic– Colorimetric S Lipase Enzymatic– Colorimetric S Magnesium Xylidyl Blue,
PhotometricS or U
Myoglobin ECLIA S pH Electrochemical BF, U Phosphorus Endpoint S or EDTA,
U Potassium ISE S or U, BF Protein, Total Turbidmetric S or U, BF Sodium ISE S or U, BF Triglycerides Enzymatic– Colorimetric S or BF UIBC Colorimetric– Ferrozine S Urea UREASE–Rate S or Urine,
BF Uric Acid Enzymatic–Colorimetric S or BF Uric Acid Uricase– Colorimetric UChemistry Special Chemistry ACTH ECLIA EDTA Aldolase ECLIA S Alpha–1–Antitrypsin Immuno–Turbidimetric S or EDTA Alpha–Fetoprotein,
Tumor MarkerECLIA S
(A2LA Cert. No. 4119.01) 01/18/2018 Page 4 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Chemistry Special Chemistry Cont. Amikacin FPIA S Angiotensin Converting
Enzymer (ACE)Kinetic S
Apolipoprotein A1 Immuno–Turbidimetric S or EDTA Apolipoprotein B Immuno–Turbidimetric S or EDTA ASO, Quantitative Latex Turbidimetry S Bence Jones Protein Electrophoresis U BNP ICMA EDTA
Plasma CA 15–3 ECLIA S CA 19–9 ECLIA S CA 27–29 ICMA S CA–125 ECLIA S Carbamazepine FPIA S CEA ECLIA S Ceruloplasmin Immuno–Turbidimetric S CK Isozymes
(CK1, CK2, CK3) Electro S
Complement C3 Immuno–Turbidimetric S or Heparin Complement C4 Immuno–Turbidimetric S or Heparin
Complement, Other Than C3 and C4, including CH50
Immuno–Turbidimetric S
Cortisol ECLIA S C-Peptide ECLIA S C-Reactive Protein,
High Sensitivity (Hscrp) Turbidmetric S
Cyclosporine ICMA S or P (Heparin)
DHEA Sulfate ECLIA S Digoxin ICMA S Erythropoietin ICMA S Estradiol ECLIA S Ferritin ECLIA S Folate ECLIA S Follicle Stimulating
Hormone (FSH) ECLIA S
Fructosamine Colormetric S or EDTA Gentamicin FPIA S Glomerular Filtration
Rate Calculation S
Haptoglobin Immuno–Turbidmetric S or EDTA HAV Antibody, Igm ICMA S
(A2LA Cert. No. 4119.01) 01/18/2018 Page 5 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Chemistry Special Chemistry Cont. HAV Antibody, Total ICMA S Hbc Antibody, Igm ICMA S Hbc Antibody, Total ICMA S Hbe Antibody EIA S Hbeag ICMA S Hbs Antibody,
QualitativeICMA S
Hbs Antibody, Quantitative
ICMA S
Hbsag ICMA S HCV Antibody ICMA S Hemoglobin A1C Colormetric P (Lav) HIV–1/2 Antibody
Rapid Test Immuno–Chromographic S
HIV–1/2 Antibody/P24 Antigen, Non–Rapid, Immunoassay
ICMA S
Homocysteine Enzymatic Kinetic S Iga, Quantitative Immuno–Turbidimetric S Igg, Quantitative Immuno–Turbidimetric S Igm, Quantitative Immuno–Turbidimetric S Immunofixation
ElectrophoresisElectrophoresis S, U
Insulin ECLIA S Kappa Light Chain,
Free, QuantitativeImmunologic S
Kappa/Lambda Ratio Immunologic S Lambda Light Chain,
Free, QuantitativeCalculation S
Lamellar Body Count (Impedance Cell Counting) (LDT)
Optical Impedance Amniotic Fluid
LD Isoenzymes (LD1, LD2, LD3, LD4, LD5)
Electrophoresis S
Lead Graphic Furnace AAS WB Lipoprotein (A) Immuno–Turbidimetric S Lithium ISE S Luteinizing Hormone
(LH) ECLIA S
N–Acetylprocainamide (NAPA)
FPIA S or P (Heparin)
(A2LA Cert. No. 4119.01) 01/18/2018 Page 6 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Chemistry Special Chemistry Cont. Paraprotein
Identification (M–Protein)
Electrophoresis S
Parathyroid Hormone (PTH)
ECLIA S or P (Heparin)
Phenobarbital FPIA S or P (Heparin)
Phenytoin FPIA S or P (Heparin)
Prealbumin Immuno–Turbidmetric S Procainamide FPIA S or P
(Heparin) Progesterone ECLIA S Prolactin ECLIA S Prostate Specific
Antigen (PSA)ECLIA S
Prostate Specific Antigen (PSA), Free
ECLIA S
Protein Electrophoresis Electrophoresis S, U Quinidine FPIA S or P
(Heparin) RBC Folate ECLIA WB Rheumatoid Factor,
Quantitative
Immuno–Turbidimetric S or P (Heparin)
Salicylate Enzymatic S or P (Heparin)
Sex Hormone–Binding Globulin (SHBG)
ECLIA S
T3, Uptake ECLIA S T3, Free ECLIA S T3, Total ECLIA S T4, Free ECLIA S T4, Total ECLIA S Tacrolimus ICMA WB Testosterone, Free EIA S Testosterone, Total ECLIA S Theophylline FPIA S or P
(Heparin) Therapeutic Drug
MonitoringFPIA S or P
(Heparin) Thyroglobulin
ICMA S
(A2LA Cert. No. 4119.01) 01/18/2018 Page 7 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Chemistry Special Chemistry Cont. Tobramycin FPIA S or P
(Heparin) Transferrin Immuno–Turbidimetric S or P
(Heparin) Troponin I ICMA S TSH ECLIA S Valproic Acid FPIA S or P
(Heparin) Vancomycin FPIA S or P
(Heparin) Vitamin B12 ECLIA S
Vitamin D, 25–Hydroxy ECLIA S
Zinc Protoporphyins Hematofluorometer WBChemistry Toxicology Forensic Alcohol/Volatiles, Legal GC Headspace U, Blood Clinical and
Forensic Alcohol/Volatiles, Medical
ADH U
Forensic Nicotine/Cotinine Rapid Test
Immunoassay U
Clinical and Forensic
Specimen Integrity Testing, Creatinine
Jaffe Reaction U
Clinical and Forensic
Specimen Integrity Testing, pH
End Point Colorimetric U
Forensic Specimen Integrity Testing, pH Workplace Forensic
pH Meter U
Clinical Specimen Integrity Testing, Nitrite
End Point Colorimetric U
Clinical and Forensic
Specimen Integrity Testing, Spec Gravity
End Point Colorimetric U
Forensic Specimen Integrity Testing, Spec Gravity Workplace Forensic
Refractometer U
Forensic Urine Drug Screening, Pre–Employment
GCMS, LCMSMS U
Forensic Urine Drug Screening, Workplace
GCMS, LCMSMS U
Clinical Urine Toxicology, Oral Immunoassay U Forensic Urine Toxicology,
Quantitative GCMS, LCMSMS U
Clinical Oral Fluid Toxicology, Qualitative
ELISA Oral Fluid
(A2LA Cert. No. 4119.01) 01/18/2018 Page 8 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Chemistry Toxicology Cont. Clinical Oral Fluid Toxicology,
Quantitative GC/MS Oral Fluid
Chemistry Urinalysis Hcg Immunoassay U Specific Gravity Refractometer U Urinalysis Dipstick,
Automated Reflectance Spectrophotometry
U
Urinalysis Dipstick, Manual
Reagent Strips U
Urine Sediment Microscopy (Including Crystal ID)
Automated Microscopy (Particle Imaging)
U
Hematology Hematology Abn. Hb Detection
(All Methods Except Solubility)
Ion–Exchange High Performance Liquid Chromatography
WB
Body Fluid Cell Count, Automated
Fluorescent Flow Cytometry
BF
Body Fluid Cell Count, Manual
Manual Microscopic Exam
BF
Body Fluid Differential Manual Microscopic Exam
BF
CD3/CD4/CD8 (HEL/SUP/T.LYMPH)
FLOW WB
CD4 (HEL) FLOW WB CD4/CD8 (HEL/SUP) FLOW WB CD8–/CD57+ FLOW WB Crystal Identification Manual Microscopic
ExamBF
D–Dimer, Quantitative Latex Immuno–Agglutination Assay (LIA)
P
DIFF. PANEL (3/4/8/19) (T.LYM/H/S/B)
FLOW WB
Eosinophil Count Mixed Technology WB Eosinophils,
Nasal Smear Wright –Giemsa Stain Nasal Fluid
ESR, Automated Photometrical Capillary Optical Clot Detection
WB
ESR, Manual Manual WB
(A2LA Cert. No. 4119.01) 01/18/2018 Page 9 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Hematology Hematology Cont. Fibrinogen Optical Clot Detection P Flow Activation Panel
CD56+16+/3/3+25+ CD3/4/8/3+25+/8+57+
FLOW WB
Semen Fructose Manual Semen Hematocrit Mixed Technology WB Hemoglobin A2
Quantitation, Non–Electrophoresis
Ion–Exchange High Performance Liquid Chromatography
WB
Hemoglobin F Quantitation (Hemoglobinopathy)
Ion–Exchange High Performance Liquid Chromatography
WB
Hemoglobin Solubility (Sickling Test)
Sodium Hydrosulfite Reduction
WB
Hemoglobin, Non–Waived
Mixed Technology WB
INR Optical Clot Detection P Leukocyte Alkaline
Phosphatase Score Naphthol Stain–Bright Field Microscopy
Blood Smear
Lymphocyte Phenotyping
FLOW WB
Mucin Clot Manual BF NK Only (CD 56) FLOW WB Nrbc Count, Automated Mixed Technology WB Parasite ID, Blood,
Other Than Malaria Manual Microscopic Exam
WB
Parasite ID, Malaria Manual Microscopic Exam
WB
Platelet Count (PLT) Mixed Technology P PT Optical Clot Detection P PTT Optical Clot Detection P RBC Count Mixed Technology WB RBC Indices (E.G.
MCV, RDW) Mixed Technology WB
Reticulocyte Count Mixed Technology WB Sperm, Presence or
Absence (Post Vasectomy)
Manual Microscopic Exam
Semen
Sperm Count, Manual Manual Microscopic Semen T–Cell Act
(CD3/4/8/HLA/25/38) FLOW WB
WBC Count, Automated Mixed Technology WB
(A2LA Cert. No. 4119.01) 01/18/2018 Page 10 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
WBC Differential, Automated
Mixed Technology WB
WBC Differential, Manual
Manual Microscopic Exam
WB
Diagnostic Immunology General Immunology Anti–Cardiolipin Iga EIA S Anti–Cardiolipin Igg EIA S Anti–Cardiolipin Igm EIA S Anti–Centromere
Antibody Multiplex Bead Assay S
Anti–Chromatin Antibody
Multiplex Bead Assay S
Anti–DNA Multiplex Bead Assay S Anti–ENA Multiplex Bead Assay S Antigliadin Antibody
Iga EIA S
Antigliadin Antibody Igg
EIA S
Anti–JO–1 Multiplex Bead Assay S Antimitochondrial M2
Antibody (AMA–M2) EIA S
Antinuclear Antibody, Qualitative
Multiplex Bead Assay S
Antinuclear Antibody, Qualitative
IFA S
Anti–Parietal Cell Antibody
EIA S
Anti–Reticulin IFA S Anti–Ribosomal P
AntibodyMultiplex Bead Assay S
Anti–RNP Antibody Multiplex Bead Assay S Anti-SCL-70 Multiplex Bead Assay S Anti-Sm Antibody Multiplex Bead Assay S Anti–Smooth Muscle
Antibody EIA S
Anti–SS–A Antibody Multiplex Bead Assay S Anti–SS–B Antibody Multiplex Bead Assay S Anti–Thyroglobulin
Antibody ICMA
S
Antithyroid Peroxidase (Antimicrosomal Antibody)
ECLIA
S
Antitissue Transglutaminase Antibody
EIA S
(A2LA Cert. No. 4119.01) 01/18/2018 Page 11 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Diagnostic Immunology General Immunology Cont. Borrelia burgdorferi
Antibody EIA S
Borrelia burgdorferi Antibody–Confirmatory
WB – Line Blot S
CMV Antibody, Igg CLIA S CMV Antibody, Igm CLIA S Cold Agglutinin Agglutination S EBNA, Antibody CLIA S EBV Antibody CLIA S EBV–VCA, Antibody CLIA S FTA–ABS IFA S Helicobacter pylori
AntibodyIgg = CLIA Iga/Igm = EIA
S
HSV Antibody HSV 1/2 Type Specific = CLIA HSV1/2 Igm = EIA
S
HSV-2 Antibody, Confirm
Rapid Immunoassay S
Infectious Mononucleosis
Agglutination S
Mumps Antibody CLIA S Mycoplasma
Pneumoniae AntibodyEIA S
Parvovirus B19
AntibodyIgg/Igm=EIA S
RPR Flocculation S Rubella Antibody,
IgG/IgM, QualitativeCLIA S
Rubeola Antibody CLIA S Syphilis Antibodies, Igg Multiplex Bead Assay S Toxoplasma Antibody Igg/Igm = CLIA S Varicella–Zoster
Antibody
Igm = EIA Igg = CLIA
S
Microbiology Bacteriology Antimicrobial
Susceptibility, Aerobes Broth Microdilution; Disk Diffusion
Other –Isolate
Antimicrobial Susceptibility, Anaerobes
Broth Microdilution Other –Isolate
Antimicrobial Susceptibility, Urine
Broth Microdilution Other –Isolate
(A2LA Cert. No. 4119.01) 01/18/2018 Page 12 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Bact. ID Other, Nucleic Acid Amplification. (Not FDA–App)
NAA SS
Bacterial ID, Respiratory Panel, (FDA App)
PCR Other – NP Swab
Bacterial Identification, Other
Culture; Biochemical Malditof
SS, W, SP, ST, U, WB, Other – Isolate
Bacterial Identification/Isolation, Anaerobic
Culture; Biochemical
SS, W, Other - Isolate
Bacterial Identification/ Presumptive ID Gonococcus
Culture; Biochemical SS, Other – Isolate
Bacterial Identification/ Presumptive ID, Throat
Culture; Biochemical SS, Other – Isolate
Bacterial Identification/ Presumptive ID, Urine
Culture; Biochemical U, Other – Isolate
Bacterial Vaginosis Rapid Test
Chromogenic Assay SS
Clostridium difficile Detection (Non–Molecular)
EIA ST
C. difficile Nucleic Acid Amplification (FDA–App)
NAA ST
Candida spp., Nucleic Acid Amplification (Not FDA–App)
NAA SS
Candida spp., Nucleic Acid Probe
DNA Probe SS
Chlamydia Trachomatis, Nucleic Acid Amplification
NAA SS, U, Other – Bodily Fluids/ Tissues
Culture Detection and Identification Anaerobic Cultures SS, W,
Other – Bodily Fluids/ Tissues
(A2LA Cert. No. 4119.01) 01/18/2018 Page 13 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Bacterial Culture, Complete ID SS, W, Other – Bodily Fluids/ Tissues
Bacterial Culture, Partial ID SS, W, Other – Bodily Fluids/ Tissues
Blood Cultures WB Genital Cultures SS, Other –
Bodily Fluids/ Tissues
MRSA Screen, Culture SS Mycoplasma Culture SS, SP, Other
– Bodily Fluids/ Tissues
Respiratory Cultures SS, SP, Other – Bodily Fluids/ Tissues
Stool Cultures ST Trichomonas Culture SS, U, Other
– Bodily Fluids/ Tissues
Ureaplasma Culture SS, U, Other – Bodily Fluids/ Tissues
Urine Cultures U
VRE Screen, Culture SS, U, ST Wound Cultures SS, W, Other
– Bodily Fluids/ Tissues
DNA Probe Non–Amplified Methods (FDA–Approved)
DNA Probe/ Hybridization
SS, Other – Isolate
Fecal Fat Testing Microscopy ST Fecal Leukocytes Microscopy ST
(A2LA Cert. No. 4119.01) 01/18/2018 Page 14 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Gardnerella vaginalis, Nucleic Acid Probe
DNA Probe/ Hybridization
SS
Gram Stain, Gonococcus
Microscopy SP, SS, ST, U, W, Other – Slide
Gram Stain, Other Microscopy SP, SS, ST, U, W, Other – Slide
H. pylori Antigen, EIA EIA ST HCV Viral Load NAA P, S HIV–RNA,
Quantitative, Nucleic Acid Amplification
NAA P
HPV, Signal Amplification (FDA–Approved)
Hybrid Capture Other – Liquid Pap Vial
HPV, Nucleic Acid Amplification (FDA–Approved)
NAA Other – Liquid Pap Vial
HPV, Genotyping (FDA–Approved)
NAA Other – Liquid Pap Vial
HSV, Nucleic Acid Amplification
NAA SS, Other – Bodily Fluids/ Tissues
Laboratory Developed Test – Bacterial Vaginosis Detection (PCR)
NAA SS
Laboratory Developed Test – Candida spp., Qualitative Detection (PCR)
NAA SS
Laboratory Developed Test – Mycoplasma spp. and Ureaplasma spp. Detection (PCR)
NAA SS, U
Legionella Antigen, Bronchoalveolar Lavage
DFA SP, Other – Bodily Fluids/ Tissues
(A2LA Cert. No. 4119.01) 01/18/2018 Page 15 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Microbiology Bacteriology Cont. Modified IVD –
Chlamydia trachomatis Detection, Ocular (TMA)
NAA SS
Modified IVD – CT / GC Detection, Rectal / Pharyngeal (TMA)
NAA SS
Modified IVD – HSV 1 and 2 Detection (PCR)
NAA SS, Other – Bodily Fluids/ Tissues
Mycobacterium spp., Nucleic Acid Probe
DNA Probe/ Hybridization
SP, S, ST, U, W, WB, Other – Isolate
Mycobacterium Tuberculosis, Nucleic Acid Probe
DNA Probe/ Hybridization
SP, Other – Isolate
Neisseria gonorrhoeae, Nucleic Acid Amplification
NAA SS, U, Other
N. gonorrhoeae, Nucleic Acid Probe
DNA Probe Other – Isolate
Occult Blood, Fecal Immunoassay ST Occult Blood, Gastric Guaiac Other –
Bodily Fluids/ Tissues
pH, Gastric pH Indicator Other – Bodily Fluids/ Tissues
pH, Stool pH Indicator ST Salmonella and/or
Shigella Typing Latex Agglutination Other –
Isolate Shiga–Like Toxin, Stool EIA ST Strep A Rapid Antigen, Immunoassay SS Strep A, Nucleic Acid
Probe DNA Probe/ Hybridization
SS
Strep B, Nucleic Acid Amplification
NAA SS
(A2LA Cert. No. 4119.01) 01/18/2018 Page 16 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
TB, Whole Blood/Plasma, Immunoassay (Quantiferon)
EIA WB
Trichimonas, Nucleic Acid Amplification (FDA–Approved)
NAA SS, U, Other – Liquid Pap Vials
Trichomonas, Nucleic Acid Probe
DNA Probe/ Hybridization
SS
Urine Colony Count Culture U Vaginal Wet Mount Microscopy SS, Other Wet Mount for Yeast Microscopy SS, OtherMicrobiology Mycobacteriology Acid Fast Bacillus
Smear Microscopy SP, SS, W,
U, Other – Slide
Antimycobacterial Susceptibility
MGIT 960, Agar Proportion
Other – Isolate
Mycobacterial Identification
Culture, DNA Probe/ Hybridization
SP, SS, U, W, ST, WB, Other –Isolate
Microbiology Mycology Mycology Culture,
Screen for Growth Only Culture SS, ST, SP,
U, W, WB, Other
Dermatophyte Identification
Culture; Microscopic and Macroscopic Observation
SS, W, Other
KOH Prep Microscopy SS, ST, SP, U, W, Other – Bodily Fluids/ Tissues
Calcofluor White Fluorescent Statin
Microscopy SS, ST, SP, U, W, Other – Bodily Fluids/Tissues
(A2LA Cert. No. 4119.01) 01/18/2018 Page 17 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Candida spp., ID / Presumptive ID from Culture
Culture; Microscopic Observation; Biochemical
SS, ST, SP, U, W, WB, Other – Isolate
Mold and/or Yeast Culture, Screen for Growth Only
Culture SS, ST, SP, U, W, WB, Other – Bodily Fluids/ Tissues
Mold Identification Culture; Microscopic and Macroscopic Observation; Biochemical
SS, ST, SP, U, W, WB, Other – Bodily Fluids/ Tissues
Yeast Identification Culture; Microscopic Observation; Biochemical
SS, ST, SP, U, W, WB, Other – Bodily Fluids/ Tissues
Microbiology Parasitology Cryptosporidium
Antigen, Preserved Specimen
EIA ST
Giardia Antigen, Preserved Specimen
EIA ST
Modified Acid Fast Stain for Intestinal Parasites
Microscopy ST, Other – Slide
Ova and Parasite Exam Microscopy ST, U Parasitology,
Complete IDMicroscopy ST, U
Parasite ID, Arthropod Microscopy Other – Parasite
Parasite ID, Fecal Microscopy Other – Parasite
Parasite ID, Other Microscopy Other – Parasite
Pinworm Prep Microscopy Other – Scotch Tape Prep
(A2LA Cert. No. 4119.01) 01/18/2018 Page 18 of 18
Specialty Sub Specialty Test/Analyte Method Matrix
Microbiology Virology Chlamydia Culture Culture SS Herpes Culture Culture SS Influenza Antigen, Non–
Waived EIA SS, Other -
NP Aspirate, Wash
Influenza, Nucleic Acid Amplification FDA Approved
NAA SS, Other – NP Aspirate, Wash
Rota Virus Antigen, Non–DFA Method
EIA ST
RSV Antigen, Non–DFA Method, Non–Waived
EIA SS, Other – NP Aspirate, Wash
Viral ID, Respiratory Panel, (FDA App)
PCR Other – NP Swab
Immunohematology Immunohematology ABO Blood Grouping Agglutination WB Antibody Screen Agglutination WB Antibody Identification Agglutination WB Direct Antiglobulin Test
(DAT) Agglutination
WB
Rh Type (Includes Weak D)
Agglutination
WB
ISO 15189:2012 Internationally-Recognized
Accredited Laboratory
A2LA has accredited LABORATORY CORPORATION
OF AMERICA Raritan, 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 18th day of January 2019.
_______________________
Senior Director, Accreditation Services For the Accreditation Council Certificate Number 4119.01 Valid to January 31, 2021
For the tests to which this accreditation applies, please refer to the laboratory’s Clinical Scope of Accreditation.