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diagnosis, treatment, prognosis
modern medicines depend on these three concepts
John Hopkins Hospital
1st clinical lab in the US
Donald D. Van Slyke
he introduced the 20 amino acids protein conversion into urea via liver
Rosalyn Yalow & Salomon Berson
they introduced radioimmunoassay (indentify ABs via radio signals; + or -)
Kohler, Milstein, & Jerne
they introduced monoclonal antibodies/ABs (specific antigens)
anatomic and clinical pathology
two departments of clinical laboratories
surgical
type of anatomic pathology department that focuses on organs (ex. kidneys)
Histopathology
type of anatomic pathology department that focuses on tissue (ex. nephrons)
Cytopathology
type of anatomic pathology department that focuses on cells (ex. structure; inflammation?)
Hematology
type of clinical pathology department that focuses on blood; coagulation, bleeding, clotting
urinalysis
type of clinical pathology department that focuses on urine
clinical chemistry
type of clinical pathology department that focuses on analytes in body fluid
microbiology
type of clinical pathology department that focuses on grow cultures from major body systems
Immunohematology
type of clinical pathology department that focuses on blood bank; immune system testing w/ blood groups; donor compatibility
Immunology & Serology
type of clinical pathology department that focuses on organ + tissue compatibility
Toxicology
type of clinical pathology department that focuses on drug testing
Specimen Collection
type of clinical pathology department that focuses on tissue, blood, & urine in outpatient area
Pathologist
clinical lab personnel that examine tissues & oversee lab results; must go to school + residency
Laboratory Manager
clinical lab personnel who does daily lab activities; must have degree & is a clinical lab scientist (CLS)
MLS/MTs
clinical lab personnel that perform routine tests + quality control + supervise & train; degree in CLS from National Accrediting Agency for Clinical Lab Sciences (NAACLS)
MLT
clinical lab personnel that perform all routine tests + supervise; associate degree in CLS from NAACLS
MLAs
clinical lab personnel that do anything as allowed by the law + admin tasks; 🚫 degree + OJT/ program from Commission on Accreditation of Allied Health Education Programs (CAAHEP)
Phlebotomists
clinical lab personnel that collect blood; OJT/ program from American Society for Clinical Pathology (ASCP)
Clinical Laboratory Improvement Act (CLIA)
law in which to enhance quality control + assurance (regulation)
Centers for Medicare and Medicaid Services (CMS)
places responsible for accreditation
Proficiency testing
validate samples
Competency testing
check personnel
automated, serologic & volumetric
different kinds of pipettes
Reagents
parallel testing via controls; change via lot # (ID tracking)
Type I, II, & III
Three types of waters (reagents)
Type I
type of water reagent classified by its minimum interference; maximum sensitivity
Type II
type of water reagent classified by its general usage in the lab
Type III
type of water reagent classified by its role for rinsing glassware
ionization
purity of water depends on this
ionization is stripped
why is type I more expensive
US Department of Labor’s Occupational Exposure to Hazardous Chemicals in Laboratories Standard (OSHA)
governing agency responsible for REGULATING safety & IMPLEMENTING new health and safety system for all workers
Clinical and Laboratory Standards Institute (CLSI)
governing agency responsible for making STANDARDIZED lab for high-quality results & patient care
Center for Disease Control & Prevention (CDC)
worldwide governing agency; PROVIDE guidelines and develop a SYSTEM for rating safety levels in clinical lab
National Health Care Safety Network (NHSN)
governing agency characterized by their role in SURVEILLANCE; infection tracking, ABs resistant, data on events (managed by CDC)
role of BSCs
protect all workers + environment + products
Class I BSC
BSC responsible for protecting everything but product (room air)
Class II BSC
BSC responsible for protecting everything (room air filter)
Class III BSC
BSC characterized by its highest level of safety
Biosafety Levels (BSL)
Describe potential biological hazard and function of lab
BSL 1
BSL that is characterized by being LOW hazard; 🚫disease; HS & undergrad
BSL 2
BSL that is characterized by being MODERATE hazard; training. Restricted lab access during work. Aerosols in BSC
BSL 3
BSL that is characterized by being HIGHLY hazardous; infection via inhalation. Training. BSC III (Two sets of self-closing & locking doors)
BSL 4
BSL that is characterized by being EXTREMELY hazardous; 🚫 cure + unknown transmission. Training not only in handling but in containment. Class III BSC w/ positive pressure suit (air always push outwards; decont. units w/ showers)
staphylococcus epidermidis
specimens that may be included in BSL 1
staphylococcus pyogenes
specimens that may be included in BSL 2
bacillus anthracis & smallpox virus
specimens that may be included in BSL 3
Ebola + COVID-19
specimens that may be included in BSL 4
Hazard Communication Standard (HSC)
federal regulation where US employers must disclose info regarding toxic/hazardous substances stated by OSHA
preanalytical, analytical, postanalytical
Three distinct phases in Specimen Processing + Control
Preanalytical phase
phase in Specimen Processing + Control concerned with sample management + interferences
Analytical phase
phase in Specimen Processing + Control concerned with quality control
Postanalytical phase
phase in Specimen Processing + Control concerned with reporting + interpretation
purple
tube selection that uses EDTA to chelate calcium for measuring whole blood
light blue
tube selection that uses sodium citrate to chelate calcium for plasma + coagulation
green
tube selection that uses sodium/lithium heparin to inhibit thrombin formation for plasma + chemistry
red
tube selection that uses clot activators to understand serum + chemistry
gold
tube selection that uses clot activator separation gels to be a polymer for storage + understand serum + chemistry
gray
tube selection that uses sodium fluoride to inhibit glycolysis in the circumstances of glucose testing + plasma