The Bureau of Clinical Laboratories:
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1 The Bureau of Clinical Laboratories:
2 Alabama Department of Public Health ~ Bureau of Clinical Laboratories Sharon P. Massingale, Ph.D., HCLD/CC(ABB) Laboratory Director
3 Mobile Regional Laboratory
4 Central Laboratory
5 Background Operational in 1908 Our Mission: To give laboratory support for public health programs and policy decisions that protect and promote the health of the citizens of Alabama specimens/samples Clinical specimens Central Lab = 376,643 Mobile Lab = 124,375 Environmental samples Central Lab = 9,866 Mobile Lab = 6,457
6 Testing Areas Montgomery Chemistry Microbiology Newborn Screening Quality Management STD Processing Sanitary Bacteriology Milk & Water STD Mobile Drinking Water Environmental Waters Rabies Shellfish STD Urine Culture BCL Divisions Support Areas Administration/Clerical/ Human Resources Business Facilities Operations Building Maintenance Purchasing/Finance Stockroom Quality Management Assessment Teams IT/LIMS Sanitary Bacteriology Decontamination Media
7 Mobile Laboratory Curtis Andrews, B.S. Division Manager
8 Clinical Urine Culture & Sensitivity Identify & quantify bacteria Determine antibiotic resistance STD Chlamydia trachomatis Neisseria gonorrhoeae Trichomonas vaginalis Treponema pallidum
9 Shellfish Partner with ADPH Seafood Branch Growing waters (fecal coliform, Vibrio, phytoplankton & cyanobacteria) Oysters (fecal coliform, Vibrio & E. coli) Crabmeats (fecal coliform & & E. coli)
10 BEACH, Drinking Water & Rabies Beaches Environmental Assessment & Coastal Health (BEACH) Act Beach water tested for Enterococci Drinking/well water E. coli & coliform Rabies
11 STD Division Traci Dailey, MT (ASCP) Division Manager
12 Human Immunodeficiency Virus Process & test serum samples Use Bio Rad Ag/Ab Combo 4 th generation screening assay Non-reactive specimens - results are reported to provider Reactive specimens Repeated in duplicate using Multispot Specimens which are reactive at least 2 out of 3 times must be confirmed Bio Rad Multispot - HIV-1/HIV-2 differentiation assay to confirm presence of antibodies Reactive specimens - reported to the provider Non-reactive or indeterminate specimens - tested using a final confirmation assay [HIV-1 rrna nucleic acid amplification test (NAAT)] NAAT Non-reactive specimens - reported as not confirmed for HIV Reactive specimens - reported as confirmed for HIV-1
13 Human Immunodeficiency Virus
14 Syphilis Testing Syphilis-EIA (IgG & IgM) Non-Reactive Report: Non-Reactive Indeterminate Report: EIA-Indeterminate Indeterminate Repeat Reactive RPR Confirmation Non-Reactive Preliminary report: EIA & RPR Reactive with dilution Report: EIA, RPR & dilution TP-PA Confirmation (IgG only) TP-PA Non-Reactive Report: EIA-Reactive, RPR-Non-Reactive, TP-PA-Non-Reactive Reactive Report: EIA-Reactive, RPR-Non-Reactive, TP-PA-Reactive
15 CT/GC/TV CT/GC Aptima Combo 2 Assay TV Aptima Assay Non-Reactive Report: CT/GC/TV Non-Reactive Indeterminate or Invalid Repeat Indeterminate or Invalid Report: Indeterminate Non-Reactive Report: Non-Reactive Reactive Report: Reactive
16 Chemistry Division Charlynda Pierce, B.S. Division Manager
17 Clinical Chemistry Hematology Complete blood count CD4/CD8 T-Cell Counts Track HIV progression HIV Viral Loads Measure virus in blood & monitors treatment effectiveness HIV Genotyping Detect mutations for drug resistance General Chemistries Complete metabolic panel, renal panel, hepatic panel, etc.
18 Lead Screening Childhood Blood Lead Screening Adult Blood Lead Screening Environmental Lead Testing Testing performed as needed Paint Water Soil Dust Wipes Other potential lead sources
19 Chemical Terrorism/Biomonitoring Cyanide Volatile organic compounds Organophosphate nerve agent metabolites Abrine/ricinine Metabolic toxins Tetramine Blood metals (Hg, Pb, Cd) Toxic elements screen in urine As/Se in urine Sulfur mustard metabolites Tetranitromethane
20 Danita Rollin, MT (ASCP) Division Manager
21 WHY DO WE SCREEN? Public Health Laws of Alabama state that each infant, 28 days or less of age, will be tested for inheritable diseases and conditions as designated by the State Board of Health. The State Board of Health shall put law into effect to provide for the care and treatment of those newborn infants whose tests are determined positive. Taken from Public Health Laws of Alabama
22 Filter Paper Forms Dried Blood Spots
23 BCL NBS LABORATORY Timing of collection, submission, testing & reporting is critical. Assist in diagnosis of 30 core disorders & 20 secondary disorders. Recommendations for test implementation originate from American College of Medical Geneticists & March of Dimes. Perform tests on a 1 st sample (mandated) & a 2 nd sample (recommended). Approximately 60,000 1 st test samples & 60,000 2 nd test samples analyzed yearly. Diagnosis is urgent for treatment of affected infants.
24 NBS DISORDER PANEL Tandem Mass Spectrometry Amino Acid Disorders Fatty Acid Disorders Organic Acid Disorders Hemoglobin (HPLC)/Biotinidase (colorimetric) Sickle Cell Disease Biotinidase deficiency Genetic screening processors (GSP)/DNA Galactosemia Congenital Adrenal Hyperplasia Hypothyroidism Cystic fibrosis Coming soon SCID (severe combined immunodeficiency)
25 SANITARY BACTERIOLOGY Angelica Webb, M.S. Division Manager
26 Media The Media Branch prepares biochemicals, agar & solutions for the Montgomery & Mobile Laboratories.
27 Dairy Test raw & pasteurized dairy samples. Milk (sheep, goat, cow) & creams are tested for antibiotics. Test flavored milk, cottage cheese, yogurt, buttermilk, ice cream, popsicles, egg nog, pasteurized creams for coliform. Dairy products must meet the minimum Grade A pasteurized milk ordinance to ensure products are acceptable within limits established by Food & Drug Administration (FDA).
28 Fluoride & Water Test for fluoride in water as directed by Centers for Disease Control & Prevention (CDC). Test drinking & private well water for E. coli & coliform according to Environmental Protection Agency (EPA) guidelines.
29 Microbiology Division
30 Conventional Microbiology Comprised of 4 sections: Enterics Isolate, identify, serotype Salmonella, Shigella, & shiga-toxin producing E.coli via biochemicals, antisera & molecular methods. Reference Isolate & identify pathogens from clinical specimens using biochemicals & staining techniques.
31 Conventional Microbiology Foods Partner with ID&O & environmentalists during outbreaks to analyze food & environmental specimens. All reportable foodborne bacterial isolates (Listeria, Campylobacter, Salmonella, Shigella, Vibrio sp., & shigatoxin producing organisms) are reported to ID&O & CDC. Parasitology Process stools by concentration wet mount & stains. Examine pinworm preparations for eggs. Identify blood parasites by stained smears & microscopy. Identify arthropods.
32 Emerging Infectious Diseases Polymerase Chain Reaction (PCR) Bordetella Chikungunya Dengue Ebola Influenza Haemophilus influenzae Malaria Neisseria meningitidis Norovirus Zika ELISA Lyme West Nile Virus
33 Emerging Infectious Diseases Pulsed Field Gel Electrophoresis (PFGE) Specimens received from Reference Bacteriology. Member of PulseNet - international organization of labs that utilize PFGE to fingerprint DNA. Images are compared to a database housed at CDC & reported. Testing allows ADPH to identify if patient samples are part of a national foodborne outbreak. Salmonella Shigella E. coli Campylobacter Vibrio Listeria MRSA Serratia
34 Bioterrorism Clinical Specimens Blood Scabs Wound/throat swabs Sputum Stool Serum Environmental Suspicious letters with white powder Swabs Air filters US. Postal Service cartridges Food Collaborators Communicable Diseases Center for Emergency Preparedness Civil Support Team Federal Bureau of Investigations
35 Tuberculosis Tuberculosis Acid Fast Bacilli (AFB) Staining Cultures Drug Susceptibilities (new TB patients) PCR (TB/rifampin resistance) Genotyping (TB Control compare genotypes & # of patients in genotype clusters)
36 Mycology Dermatophytes Yeasts Mycology Systemic fungi such as Histoplasmosis, Coccidioides,& Blastomyces 6,000 specimens/year
37 Rabies Detect presence of Rabies virus in animal brains by direct fluorescent antibody testing.
38 Quality Management Charlene Thomas, B.S., MT(ASCP) Division Manager
39 Regulatory Agencies The Quality Management (QM) Division ensures testing quality: CLIA (Clinical Laboratory Improvement Amendments) FDA (Food & Drug Administration) EPA (Environmental Protection Agency) APHIS (Animal & Plant Health Inspection Services) DOT (Dept. of Transportation) Seeking ISO accreditation
40 Regulatory Agencies CLIA Certified Labs: Mobile Montgomery County Health Departments (CHDs) Dr. Sharon Massingale is the director for all 3 CLIA certificates.
41 FDA Regulatory Agencies Montgomery Laboratory is certified to perform certain testing. EPA Mobile & Montgomery shares certifications with AL Dept. of Environmental Management. APHIS Select Agent Program certified by CDC. DOT Regulate transport of hazardous waste.
42 QM Responsibilities Review: Safety Personnel records Trainings Procedure manuals Instrument maintenance Quality control Quality assurance Graded proficiency test results
43 QM Responsibilities Patient test management STD specimen processing Management of Laboratory Information Management System (LIMS) Development/presentation of CHD trainings CHD team travels to CHDs to perform assessments Internal audit team assesses the Montgomery & Mobile labs
44 Questions?
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