MLS 220: EXAM 1 2023 with 100% correct questions and answers

Laboratory Director (PhD, Pathologist (MD), etc.) - Oversees all laboratory operations (all three branches) - Expertise in medical, scientific, technical, and regulatory matters Pathologist (MD) - Works in the pathology department - Great resource/reference for MLS - Reviews all abnormal hematologic cases along with tissue biopsies, etc "Path Review" Laboratory Supervisor/Manager - Responsible for the technical aspects of the lab - Usually an MLS with additional education (MS MLS, MBA, etc.) and administrative experience Department Supervisor - Responsible for the technical areas of the department - Usually an MLS with additional education (MS MLS, etc.) Schooling for Medical Laboratory Scientist (MLS) Bachelors of Science - 4 Year Degree Schooling for Medical Laboratory Technician (MLT) Associates of Applied Science - 2 Year Degree What is Scope of Practice Range of responsibility What is DCLS Doctorate in Clinical Laboratory Science DCLS First graduate in 2018, Rutgers University Bridges the gap between the patient, care team on the floor, and the laboratory Responsibilities - Patient care management - Education - Research applications - Health care policy development - Health care services delivery and access Laboratory Information Services/System (LIS) - Laboratory computer program (EPIC, Beaker, etc.) - Electronic Medical REcord (EMR) - "Hospital Blackboard" Specimen Processors Prepare specimens for testing - Centrifugation, plasma separation, send out testing etc. Clerical Services - Receives samples into the lab via barcoded tracking - "Front" of the lab - Answer phones, manage paperwork, etc. Phlebotomist (OJT or Cert) - Draws blood samples from patients - Large Hospitals can have entire times - Small Hospitals may not employ Hematology Testing - Hemostasis/Coagulation - Urinalysis Clinical Chemistry Testing Urinalysis Specialty Labs - Flow Cytometry - Molecular Diagnostics - Toxicology - Many others What labs falls under the "Core Lab"? Hematology and Clinical Chemistry What is Hematology/Hemostasis Study of the formed elements of blood - Red blood cells, white blood cells and platelets Performs blood coagulation tests Diseases and Conditions - Leukenias, anemias, anticoagulant monitoring (ie. heparin), etc. Clinical Chemistry Qualitative and quantitative analysis of constituents on whole blood serum, urine, and other body fluids - Ie. Glucose, Sodium, Troponin etc. Diseases and Conditions - Heart Attack, Diabetes, Thyroid Cancer etc. Urinalysis Examination of urine via physical, chemical, and microscopic analysis May be a subset of Hematology or Chemistry Diseases and Conditions - Urinary Tract Infection, Renal Disease, etc. Microbiology Detection of bacteria, parasites, fungus, and viruses in the human body Variety of sample types - Blood Urine, Whole Body Parts, Tissue, etc. Diseases and Conditions - Infection, Sepsis, Strep Throat, COVID, etc. Immunogematology (Blood Bank Transfusion) Blood products are tested and prepped for patients - RBCs, Platelets, Plasma [not only] Blood transfusions (Traumas, pregnancy, anemias, etc.) Examples of Specialty Testing Many different categories of specialty testing - Allergens, Toxicology, Edocrinology, Fertility, Gastroenterology, Genetics, Molecular Diagnostics, Neurology, Newborn Screening and Pediatrics and Oncology What is another term for test? Assay What is an analyte? Substance or component What is Qualitative? Asks the question: is it present? - Positive vs. Negative What is Quantitative? Ask the question: how much is present? - Numerical Concentration (ie. 10 mg/dL) What is a Panel? A collection of tests ordered at the same time and under one order What are the components of a Basic Metabolic Panel (BMP)? - Sodium (Na), Potassium (K), Chloride (Cl) - Carbon Dioxide (CO2) - Blood Urea Nitrogen (BUN) - Serum Creatinine - Serum Glucose - Total Calcium What is a Testing Algorithm? Test "Map" or "Flowchart" - Examples are Syphilis Serology Algorithm What are Laboratory Organization dependent on? - Laboratory Size - The number of tests done - Facilities/Supplies available What is the makeup of Large Labs? - Departmentalized - Specialized Techs - Large Test Catalog such as Mayo Test Catalog What is the makeup of Small Labs? - "One Room Schoolhouse" - Limited testing menu Different Types of Laboratory Locations - Traditional Hospital Labs - Clinic Labs: Affiliated with Hospital Lab and Courier Service - Reference Laboratories: Perform complex testing and "send out" - Point of Care Testing (POCT) Laboratory Locations - Staffing for different places - Clinic Laboratories: Day Time Hours (7am-4:30am) could be evening hours - Hospital Laboratories: Staffed 24 hours a day. Day Shift 6am-2:30pm, PM/Relief Shift 2:00pm-10:30pm and night shift 10pm-6:30am - Reference Laboratories: Varies What are the roles of Professional Organizations - Advocacy, education, regulation - Membership Required What is ASCP? American Society for Clinical Pathology - Board of Directors/Committees - Volunteer opportunities - Educational opportunities and scholarships - National Conference - Board of Certification Exam What is ASCLS? American Society for Clinical Laboratory Science - National, Regional and State Level Societies: Volunteer opportunities and Conferences - Educational opportunities and scholarships - Advocacy for the profession: Laboratory Legislative Symposium, Licensure and Patient Safety CLMA Clinical Laboratory Managers Association AABB American Association of Blood Banks AACC American Association for Clinical Chemistry ASM American Society for Microbiology ASH American Society of Hematology Board of Certification BOC - Credential maintenance (CM) - AMT vs. ASCP American Medical Technologists (AMT) - Certification Exam ~ Medical Technologist (MT) designation American Society for Clinical Pathology Exam Board of Certification Exam - Gold Standard - Eligibility - Continuing Maintenance (Program) (CM) -> Every three years - Medical Laboratory Scientist (MLS) designation Speicalist Examinations -> Hematology, Microbiology, etc State Licensure - 11 states (CA, HI, FL, NY, ND, TN, LA, NV, WV, MT, GA) - Requirements such as licensing fee, minimum education, BOC, continuing education and professional competency What is accreditation? A process through which an institution (college, hospital, etc.) undergoes to ensure competency, authority, and/or credibility. - Performed by an accrediting body - Standards must be met, applications submitted, etc. Who undergoes accreditation? Postsecondary Education Institutions (colleges): Postsecondary Education Departments Hospitals: Laboratories; Laboratory Departments What is NAACLS? National Accrediting Agency for Clinical Laboratory Sciences - Accrediting Agency for MLS Programs (including UND MLS) - Provides guidelines, benchmarks, and standards that must be met by the program The Joint Commission (TJC) - Accredits hospital laboratories as well as freestanding entities (whole hospitals, blood collection centers, etc.) Commission on Laboratory Accreditation (COLA) - Founded in 1988 to help laboratories stay in compliance with CLIA '88 - 1997 ~ "Deeming Authority" under CLIA by Centers for Medicare and Medicaid Services (CMS) - Recognized by the Joint Commission College of American Pathologists (CAP) - Internationally recognized - Deeming authority granted by CMS - Recognized by The Joint Commission - Utilizes teams of practicing laboratory professionals as inspectors Specialty Accreditation Groups - American Association of Blood Banks (AABB) - American Association of Clinical Chemists (AACC) - American Society for Microbiology (ASM) Centers for Medicare and Medicaid Services (CMS) - Government agency ~ under Department of Health and Human Services (HHS) - Regulates all laboratory testing performed on humans in the US - Clinical Laboratory Improvement Amendments (CLIA): CLIA Certificate (License) Board of Certification Exams - ASCP - AMT Professional Licensure State specific Professional Organizations - ASCP - ASCLS MLS Department Accreditation - NAACLS Primary Laboratory Accrediting Bodies - TJC - COLA - CAP Laboratory Licensure - CLIA (Through CMS) Federal Laws and Regulations are established to protect what? - Laboratory staff - Other health care personnel - Patients treated in the healthcare facility - Society as a whole U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) - CLIA '88 - HIPAA - Clinical Laboratory Fee Schedule (CLFS) Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) Goal and tasks To ensure that laboratory testing results that are reported are of high quality regardless of where the testing is performed - Proficiency Testing Programs - Quality Assessment Programs - Use of Quality Control Systems - Inspections and Site Visits - Personnel Requirements CLIA '88 - CLIA Licenses and Test Complexity Labs are licensed based on the complexity of the testing that they will performing. Tiered Test Complexity Criteria - Risk of harm to the patient - Risk of erroneous result - Type of testing method used - Degree of independent judgement and interpretation needed - Availability of the particular test in question for home use Waived Testing - Tests cleared by the FDA that are simple and have a low probability of producing an erroneous result - High school diploma + training - Glucose monitors, pregnancy tests, etc. (point of care testing) - "Certificate of Waiver" - Labs are exempt from: standards for personnel, quality control programs, proficiency testing, and quality assessment programs Moderate Complexity Testing - MLT/MLS - Ex. Urine microscopics, some hematology/chemistry testing - CLIA Certificate ~~ Minimal personnel standards, proficiency testing, quality assessment programs High Complexity Testing - MLT/MLS - Ex. Blood typing, crossmatching, PCR testing, etc. - CLIA License ~~ Minimal personnel standards, proficiency testing, quality assessment programs Provider - Performed Microscopy (PPM) Ex. Vaginal wet prep (bacteria, fungus, parasites) CLIA Certificate Generally performed by a physician in the office setting Specific criteria - Examination must be personally performed by qualified personnel (physician, dentist, etc.) - The procedure must be categorized as moderately complex - The primary instrument for performing the test is the microscope (bright field or phase-constrast microscopy) - The specimen is labile - Control materials are not available - Specimen handling is limited CLIA '88 - Document Control All laboratory procedures must be made available to laboratory personnel - All procedures and any changes made must be authorized by the laboratory director A copy of each procedure, date of first use, and date of discontinuance must be retained for at least 2 years after a procedure has been removed from service SOP - Standard Operating Procedure What are CLIA '88 Key Players 1. The Food and Drug Administration (FDA) 2. Center for Medicaid Services (CMS) 3. Centers for Disease Control and Prevention (CDC) The Food and Drug Administration (FDA) - Categorizes tests based on complexity - Reviews requests for Waiver by application - Develops rules/guidance for CLIA complexity categorization Center for Medicaid Services (CMS) - Issues laboratory certificates and collects user fees - Conducts inspections and enforces regulatory compliance - Publishes CLIA rules and regulations Centers for Disease Control and Prevention (CDC) - Provides analysis, research, and technical assistance - Develops technical standards and laboratory practice guidelines - Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC) Health Insurance Portability and Accountability Act (HIPAA) 1996 - Privacy of Patient Information and TEsting Results (CMS) LIS tracking and security HIPAA Violations - Looking up your own chart in the LIS - Looking up someone else's chart in the LIS (that you are not performing testing on) - Discussing patients with family and friends - Discussing patients with coworkers outside of the laboratory HIPPA - CPT Codes Current Procedural Terminology (CPT) codes Uniform language for doctors, health care professionals, insurance complanies, etc. - Billing Alphanumeric - Ex. 80053: CMP (Complete Metabolic Panel) Informed Consent - Legal consent granted by the patient whereby he or she is made away of, understands, and agrees to the nature of the testing or services to be done - Ex. HIV testing waiver, Bone MArrow Biopsy,e tc. - Vs. Implied Consent -> Phlebotomy Patient Access Regulations - Patients must have access to their laboratory testing results within 30 days of said test being performed - Usually provided in the patients EMR (Electronic Medical Record) Chain of Custody - Each step of the analysis, beginning with the collection -> all the way to the analysis and reporting of results, must be documented - Ex. Legal Blood Alcohol Draws ~~ Special Kit, Must be drawn in the presence of a law enforcement officer, etc. Other Federal Laws and Regulations - Chemical waste disposal regulations - Use of hazardous chemicals - Issues of laboratory safety for personnel - Handling of biohazardous materials - Application of Standard Precautions OSHA Occupational Safety and Health Administration - U.S. Department of Labor - "Occupational Safety and Health Act of 1970" - Safety Standards and Plans CDC Centers for Disease Control and Prevention - U.S. Department of Health and Human Services, Public Health Service (PHS) - Guidelines BOB Bureau of Biologics - Falls under the FDA - Regulation and Production of... ~~Allergenics ~~Cellular and Gene Therapy Products ~~Vaccines ~~Tissue and Tissue Products Other Governing Agencies - Office of Inspector General (OIG) - Department of Transportation (DOT) CLSI Clinical and Laboratory Standards Institute - Global leader in harmonization and standardization - Harmonized Terminology Database CAP and TJC College of AMerican Pathologists and the Joint Commission - Accreditation -> Laboratory Safety OSHA - Standards and Plans - Chemical Hygiene Plan (CHP) - Hazard Communication Standard (HCS) - Exposure Control Plan (ECP) ~~Safety Standards for Bloodborne Pathogens Chemical Hygiene Plan (CHP) OSHA Mandate - 1991 Written document developed by the employer Includes topics such as... - Chemical Inventory - Safety Data Sheets (SDS) - Chemical labeling requirements - Standard Operating Procedures (SOP) - Eyewashes/Safety Showers (Engineering Controls) - Personal Protective Equipment (PPE) - Waste removal disposal Hazard Communication Standard (HCS) HCS 1983 - "right to know" Rev. 2012 - "right to understand" Aligns U.S. with Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Major Changes - Hazard Classification - Information and Training - Labels - Safety Data Sheet (SDS) -> Prev. MSDS HCS - Labels Manufacturer/Importer must provide a label - Signal Word - Pictogram - Hazard Statement - Precautionary Statement Globally Harmonized System (GHS) Pictograms - GHS Number - Signal Word and Meaning - Picture -> red diamond, white background Exposure Control Plan (ECP) Occupational Exposure to Bloodborne Pathogens - 1992 - OSHA Mandated Program - Requires that laboratories 1. Have a plan that ensures the safety of laboratory employees from potentially infectious bloodborne pathogens 2. Manage and handle medical waste properly Written document developed by the facility Ensure the safety and protection of laboratory employees from bloodborne pathogens - Personal Protective Equipment (PPE) - Handling and Disposal of Sharps - Exposure procedure - Standard Precautions (CDC) ECP - Safety Standards for Bloodborne Pathogens - Training - upon hire and annually - Infectious Disease Prevention - Laboratory Practives - First Aid Standard Precautions - Recommended safety policies used fro handling all biological (patient) samples - Treat every specimen as if it were infectious - Categories: Hand Hygiene, PPE use, Respiratory hygiene/cough etiquette, patient placement, care of the environment, worker safety Personal Protective Equipment (PPE) - Workplace hazard assessment with a written hazard certification - Proper equipment selection - Employee information and training, with written competency certification - Regular reassessment of work hazards - Lab Coat -> sleeves down, buttoned - Gloves -> Not a substitute for handwashing - Eye Protection/Face Shield (if necessary) Most effective to least effective for Hierarchy of Controls Elimination, Substitution, Engineering Controls, Administrative Controls, PPE Engineering Controls - CDC-> National Institute for Occupational Safety and Health (NIOSH) - Designed to remove the hazard at the source, before it comes into contact with the worker - Examples: Ventilation, BSCs, Vacutainer Needle Shields, Sharps Container, Body Shields Laboratory Hazards - Biohazard/Bloodborne Pathogen Protection - Chemical Safety - Fire Safety - Electrical Safety Biohazard Denotes infectious materials or agents that present a risk or even a potential risk to the health of human beings or animals in the laboratory Risk The probability that a health effect with occur after an individual has been exposed to a specified amount of a hazard Risk assessment A process of gathering all available information on a hazardous substance and evaluating it to determine the possible risks associated with exposure Laboratory Disposal: Black Can Anything that is not a sharp (needle/glass) or contaminated with a biohazard Examples: - Lens paper - Wrapper from a swab - Plastic Cap NO GLOVES Laboratory Disposal: Biohazard Trash Orange or red bag lined can Anything contaminated with a biohazard (bloody, body fluid, urine etc.) that isn't a sharp (needle/glass) Examples: - Tube of blood - Gauze with blood on it - Swab with bacteria on it - UND MLS: Any gloves (contaminated or not) Laboratory Disposal: Sharps Container hard red can (no bag) - Examples: glass -> glass sides, tubes, needles, contaminated or not Biosafety management plan Addresses the laboratory practices and procedures designed or intended to reduce risks associated with potential biological safety hazards Biosafety Practices Apply safety precautions that reduce a laboratory staff member's risk of exposure to a potentially infectious microoorganism and limit contamination of the work environment and the community Biosafety Levels Levels of containment assignmed to labs in regards to the organisms and materials that are handled in said lab BSL-1 Least Hazardous Risk of disease in healthy adults present minimal potential hazard - Example: Nonpathogenic strain of E. coli Requirements: - Standard microbiological practices are followed - Work can be performed on an open lab bench or table - PPE is worn as needed BSL-2 Moderate hazards to laboratory staff and environment Microorganisms associated with disease - Ex. Staph aureus or Zika virus Requirements: - Access to the laboratory is restricted when work is being conducted - PPE is worn as needed - All procedures that may cause infection from aerosols or splashes are performed within a biological safety cabinet (BSC) - An autoclave (method for decontamination) is available for proper disposals BSL-3 Builds upon the requirements of BSL-2 Microorganisms may cause serious or potentially lethal disease through respiratory transmission - Ex. Mycobacterium tuberculosis Requirements: - Laboratorians are under medical surveillance and may be required to receive specific immunizations - Access to the laboratory is restricted and controlled at all times - Appropriate PPE is worn and respirators may be required - All work with microbes must be performed within an appropriate BSC BSL-4 Builds upon requirements of BSL-3 High risk of deadly aerosol-transmitted infections No treatment or vaccines - Ex. Ebola and Marbug Viruses Requirements: - Change clothing before entering - Shower upon exiting - All work with the microbe must be done in a class III BSC OR while wearing a full body, air-supplied, positive pressure suit - Lab is in a separate building or in an isolated/restricted area of the building - Lab has its own dedicated air supply and exhaust, as well as vacuum lines and decontamination systems Laboratory-Acquired Infections (LAI) Infection acquired through laboratory or laboratory-related activities Routes of Exposure/Accidental Inoculation - Inhalation - Percutaneous Inoculation - Contact between mucous membranes and contaminated material - Ingestion Majority caused by disregarding biosafety practices; followed by human error Inhalation aerosol sprays from syringes, uncapping specimen tubes, and centrifuge accidents Percutaneous Inoculation Needle and syringes, cuts or abrasions, animal bites Mucous Membranes hands and surfaces Ingestion Mouth pipetting, smoking and eating Most Commonly Implicated Bacteria - Brucella spp. - Salmonella typhi - Mycobacterium tuberculosis Most Commonly Implicated Viruses - Hepatitis B (HBV) - Hepatitis C (HCV) - Human Immunodeficiency Virus (HIV) General Infection Control Practices - Standard Precautions - No food or drink in the lab - Specimens to be centrifuged should always be centrifuged with the cap on - Rubber-stopped tubes (ex. Blood collection tubes) should always be opened slowly with a biohazard wipe over the stopper - No mouth pipetting - No smoking in the lab - No manipulation of contact lenses or chapstick/makeup application in the lab - Stay up to date on employer required vaccinations Disinfection Elimitated many or all pathogenic microorganisms, except bacterial spores, on inanimate objects - Healthcare Settings -> Liquid Chemical What effects how well the disinfectant will work? - Prior cleaning of the object - Type and level of microbial contamination - Concentration of and exposure time to the germicide Contact Time - Physical nature of the objects - Presence of biofilms Storage for Chemical Safety OSHA approved metal storage cabinets - Proper Ventilation - Keep doors closed Fume Hoods Used for Organic Solvents and disposal of flammable solvents in the sewer is prohibited - NOT the same as a Biological Safety Cabinet (BSC). Only protect personnel from chemical fumes, unfiltered air from the cabinet is vented outside Chemical Fume Hood - Used when handling dangerous chemicals - Protects the user - No HEPA filter - Exhausts air outside the building Biological Safety Cabinet - Used when handling infectious biological agents - Protects the user, the environment and the material - Must have HEPA filter - Does not exhaust air outside the building, unless it has been decontaminated first Safety shower and eye wash station - Contacts must be removed and eyes rinsed for 15 minutes Electrical Safety - Shock and fire hazard - OSHA: all electrical equipment must be grounded and follow the National Fire and PRotection Association's (NFPA's) National Electrical Code - Regular inspection -> routine users/biomedical departments - Electrical equipment should not be handled with wet hands Fire Safety Annual fire safety training is mandatory Five Classes of Fires - Class A: Ordinary Combustibles - Class B: Flammable liquids and gases - Class C: Electrical equipment - Class D: Powdered metal (combustible) metal - Class K: Cannot be extinguished - Fire extinguishers: Water, CO2, Halon 1211 and 1301 Foam, Loaded Steam, Dry Chemical Safety Officer Responsible for initial orientation of staff and the updating of staff as needed, recommended safety training schedule Safety Coaches Communicate, Educate, Role Model, Observe, Correct as needed Types of Lab Ware - Containers and Receivers - Volumetric Ware - Pipettes Types of Laboratory Equipment - Lab Ware - Laboratory Balances - Centrifuge Advantages of Plastic Lab Ware - Less Expensive - More Durable/Unbreakable - Glass can be damaged by certain chemicals (ex. Alkaline solutions must be stored in plastic) Disadvantages of Plastic Lab Ware - Permeability to water vapor - Evaporation - Absorption of dyes, stains or proteins Advantages of Glass Lab Ware - Less permeable/less absorption - Easily washable and reusable Disadvantages of Glass Lab Ware - More expensive - May corrode or break over time (some reagents may eat away at glassware which makes it less accurate) Types of Glass 1. Borosilicate (Thermal-Resistant) Glass 2. Alumina-Silicate Glass 3. Acid-Resistant and Alkali-Resistant Glass 4. Low-ACtinic (Amber Colored) Glass 5. Flint Glass (soda lime glass) 6. Disposable Glass Borosilicate (Thermal-Resistant) Glass Commercially -> Pyrex Most commonly used for laboratory grade glassware - Beakers, flasks, pipettes Resistant to heat, corrosion, thermal shock Alumina-Silicate Glass - Used for high precision analytical work due to its radiation resistance - Also used for optical reflectors and mirrors - Generally NOT used for common laboratory glassware Acid-Resistant and Alkali-Resistant Glass - Used with strong acid or alkaline solutions - "soft glass" -> much less thermally resistant (compared to borosilicate glass) Low-Actinic (Amber Colored) Glass - Reduce the amount of light traveled through them - Used for light sensitive substances (ex. bilirubin, vitamin A, etc.) Flint Glass (soda lime glass) - Least expensive - Low thermal and chemical tolerance - Variety of glassware (household uses -> cheaper bakeware) - Not generally used for analytical work Disposable Glass - Inexpensive - Not designed to be washed and reused - Test tubes, glass slides, etc. Lab Ware Specifications Calibration Accuracy Tolerances ~ NIST - Class A: most accurate for measuring liquids and can be as low as 0.08mL for a Class A 100mL flask or pipette - Class B Vessels holding or transferring liquid - To Contain "TC": holds a calibrated volume of liquid - To Deliver "TD": disperses a calibrated volume of liquid Lab Ware: Containers and Receivers - Ex. Beakers, test tubes, erlenmeyer flasks, reagent bottles - Calibrated to hold various volumes (as opposed to one) TC to contain - Less expensive (vs. volumetric ware) Lab Ware: Volumetric Ware - Ex. Pipettes, volumetric flasks, graduated cylinders, burets Beakers - Wide, straight-sided cylindrical vessel - Used for general mixing and reagent preparation Erlenmeyer Flasks - Used for preparing reagents and titration procedures Test Tubes - Usually disposable - May be made of borosilicate glass ~ resistant to thermal shock and chemical reactions or disposable glass (cheap) Reagent Bottles - Reagents ~ chemicals used in the testing process - Glass or plastic - Many different volumes Volumetric Glassware Calibrated to deliver/contain a specific volume (regulated by NIST) - Via weight using DI water at 20 degrees Celsius - "unit of capacity": can be found on the glassware - Graduated calibrated markings - Rigorous calibration process makes this glassware more expensive Readings should be made at the meniscus of the liquid level