MLAB 1101 Introduction to Clinical Laboratory Science by oym20829

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									      MLAB 1101
Introduction to Clinical
  Laboratory Science
         Instructor:
   Cecile Sanders, M.Ed.,
        MLS(ASCP)
Unit #1 Introduction to
 Laboratory Medicine
       Unit #1 Introduction to
        Laboratory Medicine
   Definition of Clinical Laboratory
 A.
 Science – A profession concerned with providing
 information based on the performance of analytical tests
 on human body substances to detect evidence of or
 prevent disease or impairment and to promote and monitor
 good health.
   Scope of Practice (American Society
 B.
 for Clinical Laboratory Science -
 ASCLS) – Assuring reliable test results which
 contribute to the prevention, diagnosis, prognosis, and
 treatment of physiological and pathological conditions.
            Unit #1 Introduction to
             Laboratory Medicine

   C. Overview of Clinical Laboratory Science Profession

    Read information on the role of the MLT/MLS in the clinical
    laboratory from the American Society for Clinical Pathology:
    http://www.ascp.org/MainMenu/laboratoryprofessionals/CareerCenter.aspx



    (See Unit #1 Assignment for further information on this
    website)
        Unit #1 Introduction to
         Laboratory Medicine
   D. History of Clinical Laboratory
    Science
    – Evidence of blood fluid testing as early as
      1500 B.C.
    – First clinical lab opened at Johns Hopkins
      Hospital in 1896 (Baltimore)
    – American Society for Clinical Pathology
      (ASCP) formed in 1922 (originally named
      “American Society of Clinical Pathologists”)
    – ASCP Board of Registry formed in 1928 to
      certify clinical laboratory personnel
       Unit #1 Introduction to
        Laboratory Medicine
 D.History of Clinical Laboratory
 Science (cont’d)
  – American Society for Clinical Laboratory
    Sciences (ASCLS) formed in 1933
    (formerly named “American Society for
    Clinical Laboratory Technicians”, “American
    Society for Medical Technologists”,
    “American Society for Medical
    Technology”)
  – First autoanalyzer introduced in 1957
         Unit #1 Introduction to
          Laboratory Medicine
   D. History of Clinical Laboratory Science
    (cont’d)
    – Medicare and Medicaid established in 1960s
    – National Credentialing Agency for Laboratory
      Personnel (NCA) formed in 1976 by ASCLS
    – Clinical Laboratory Improvement Act in 1988
    – NCA assumed by ASCP on October 23, 2009
       Unit #1 Introduction to
        Laboratory Medicine

 E.Organization of a typical clinical
 laboratory
  – Located in hospitals, clinics, doctors’ group
    practices, single doctor offices, health
    departments, reference laboratories
   Unit #1 Introduction to
    Laboratory Medicine
– Departments
   Chemistry   – body fluid components
 Unit #1 Introduction to
  Laboratory Medicine

 Microbiology   – pathogenic microorganisms
 Unit #1 Introduction to
  Laboratory Medicine
 Hematology   – whole blood analysis and
 coagulation
 Unit #1 Introduction to
  Laboratory Medicine

 Urinalysis
 Unit #1 Introduction to
  Laboratory Medicine

 BloodBank (Immunohematology) – transfusion
 related testing
 Unit #1 Introduction to
  Laboratory Medicine

 Serology   (Immunology) – antibody studies
 Unit #1 Introduction to
  Laboratory Medicine

 SpecimenCollecting and Processing – includes
 phlebotomy
        Unit #1 Introduction to
         Laboratory Medicine

 F.   Requesting a Laboratory Test
  – Only a physician can order a lab test
    Unit #1 Introduction to
     Laboratory Medicine
– Categories of Test Requests
   Routine
   ASAP   (as soon as possible)
   STAT (from Latin word “statim”, meaning “with
    haste”)
   Pre-Op (pre-operative)
   NPO (from Latin words “non per os”, meaning
    “nothing by mouth)
   pp (or pc) (post-prandial or “after eating”)
     – pp literally means post-breakfast
     – pc literally means post-meal
            Unit #1 Introduction to
             Laboratory Medicine
   G. Educational Requirements for Clinical Laboratory
    Personnel
    –   Phlebotomist
           High school graduate or equivalent
           Certification (passing a national proficiency exam) preferred
           Austin Community College offers Phlebotomy training – visit
            http://www.austincc.edu/health/phb/ or call 223-5918 for
            information
    –   Medical Laboratory Technician (MLT-ASCP)
           Associate’s degree or 1 year certificate
           Certification required
           Austin Community College offers MLT Program – visit
            http://www.austincc.edu/health/mlt/ or call 223-5918 for
            information
       Unit #1 Introduction to
        Laboratory Medicine
– Medical Laboratory Technologist (MLS-ASCP)
      Bachelor's degree
      Includes a formal training program
      MLS/CLS training may be:
         – 3 years general college plus one year hospital internship - U.T.
           Austin offers this type of degree;
           http://www.biosci.utexas.edu/cls/ for information
         – Associate’s degree in MLT plus two years additional years of
           professional training – U.T.M.B. Galveston offers this type of
           degree; http://sahs.utmb.edu/cls/ for information
         – Completion of bachelor’s degree and one year hospital internship –
           Austin State Hospital offers this type of internship;
           http://www.dshs.state.tx.us/mhhospitals/AustinSH/ResMedTech.s
           htm for information
         – 4 years college, which includes professional training and hospital
           internship – Texas State University offers this type of degree;
           http://www.health.txstate.edu/cls/ for information
        Unit #1 Introduction to
         Laboratory Medicine
–   Specialists – Requires MLS and several years of
    documented experience, plus certification
    through ASCP (examples: SBB = Specialist in
    Blood Bank, SH = Specialist in Hematology, SM =
    Specialist in Microbiology, etc.)
–   Pathologist – M.D. (4 years college and 4 years
    medical school) + 4-5 years of residency training
    in pathology
       May be certified in:
        – Anatomical Pathology (AP) and/or
        – Clinical Pathology (CP)
       Unit #1 Introduction to
        Laboratory Medicine
 H.Clinical Laboratory Improvement Act
 of 1988 (CLIA ’88)
  – http://www.cms.hhs.gov/clia/
  – Actually implemented on Sept. 1, 1992
  – Divides all clinical labs into “waived”,
    “moderately complex”, and “highly
    complex” categories
 Unit #1 Introduction to
  Laboratory Medicine
 Waived   laboratories
  – Perform tests that are so simple and accurate as to
    render the likelihood of errors of results negligible
  – Have no certification or education requirements for
    testing personnel
  – Do not require proficiency testing (external
    comparison of laboratory quality control)
  – Waived tests include tests listed on
    http://www.cms.hhs.gov/clia/ under “Categorization
    of Tests” on left side of web page
 Unit #1 Introduction to
  Laboratory Medicine
 Moderately   Complex
  – Mainly manual procedures with limited steps and
    preparation and automated analyses that do not
    require operator intervention during the analytical
    process
  – Requires proficiency testing. If lab fails, it can be
    prevented from doing the analyte failed.
  – Testing personnel must have a minimum of high school
    graduation plus completion of 50 weeks of military
    training or other appropriate documented training
 Unit #1 Introduction to
  Laboratory Medicine
 Highly   Complex
   – Designation for labs that perform ALL laboratory
     testing, including highly specialized
   – Requires extensive proficiency testing
   – Testing personnel must have at least an associate’s
     degree in a laboratory science
     Unit #1 Introduction to
      Laboratory Medicine
 Governmental  Agencies that regulate
 the roles of clinical laboratories (all are
 within the Department of Health and
 Human Services – HHS – which is
 charged with safeguarding the health of
 the public and providing those health
 services seemed essential to the
 maintenance of good health)
    Unit #1 Introduction to
     Laboratory Medicine
– CDC (Centers for Disease Control and
  Prevention)
   Monitors  disease outbreaks, implements disease
    prevention strategies, and maintains national
    health statistics
   Provides immunization services, workplace
    safety, and environmental disease prevention
    guidance
   Monitors international disease transmission
   Administers the Agency for Toxic Substances
    and Disease Registry
    Unit #1 Introduction to
     Laboratory Medicine
– CMS (Centers for Medicare and Medicaid
  Services)
   Administers  Medicare, a federal healthcare
    coverage plan for the elderly, those with severe
    kidney damage who require dialysis, and people with
    certain disabilities
   Works with states to administer Medicaid,
    healthcare coverage for individuals living at or below
    poverty levels
   Controls Medicare and Medicaid payment for
    medical procedures, including laboratory services
   Regulates enforcement for CLIA
   Enforces the Health Insurance Portability and
    Accountability Act of 1996 (HIPAA, Title II)
    Unit #1 Introduction to
     Laboratory Medicine
– FDA (Food and Drug Administration)
   Monitors  safety and effectiveness of food,
    drinks, cosmetics, drugs, and medical devices
   Determines whether a laboratory test is
    classified as waived, moderately complex, or
    highly complex
      Unit #1 Introduction to
       Laboratory Medicine
 Professionalism
  – Definitions
     Accreditation  – voluntary process in which a
      non-governmental agency grants recognition to
      institutions or programs that meet or exceed
      established standards of quality. Example:
      MLAB Program at ACC is accredited by
      NAACLS; ACC and other schools are accredited
      by SACS; some clinical labs accredited by CAP.
 Unit #1 Introduction to
  Laboratory Medicine
 Registration– a general term referring to the
 voluntary requirement that all persons who
 engage in a given occupation register with the
 designated government agency. It does NOT
 require minimum education or experience
 requirements. Examples: Medical technology in
 the state of Texas
 Unit #1 Introduction to
  Laboratory Medicine
 Certification – a process by which an individual
  or institution is evaluated and recognized as
  meeting certain predetermined standards.
  Usually non-government and voluntary.
  Examples: ASCP exam for medical technology
 Licensure – often referred to as a “practice
  act”. Not voluntary. The granting of
  permission by an authority (usually a state) to
  an individual or organization in some practice or
  activity. Examples: State licensure for
  physicians, nurses (NOTE: Texas does NOT
  require licensure for clinical laboratory
  professions!)
    Unit #1 Introduction to
     Laboratory Medicine
    Continuing Education – professionalism includes
    continuing your education after
    graduation/certification. Technology and
    medical research move at lightning speed, and it
    is VITAL for all health professionals to keep up
    with changes and developments in their fields.
    ASCP REQUIRES continuing education in order
    to maintain certification. ASCP offers a free
    Maintenance Certification Program for members
    to keep track of continuing education
    http://tinyurl.com/l32gkf
    Unit #1 Introduction to
     Laboratory Medicine
– Certification and Accrediting Agencies and
  Professional Organizations
   Certification    Agencies
     – American Society of Clinical Pathologists (ASCP) –
       Board of Registry (BOR) established in 1928
       http://www.ascp.org/FunctionalNavigation/certification.aspx
     – American Medical Technologist (AMT) – 1939
       http://www.amt1.com/
     – American Association of Bioanalysts (AAB) Board of
       Registry 1999 (Formerly called International Society
       for Clinical Laboratory Technology ISCLT       –
       1962)
       http://www.aab.org/aab/American_Board_of_Bioanalysis.asp
    Unit #1 Introduction to
     Laboratory Medicine
   Accreditation Agencies
     – National Accreditation Agency for Clinical Laboratory Sciences
       (NAACLS) – 1973 http://www.naacls.org/

     – Joint Commission on Accreditation of Healthcare Organizations
       (JCAHO) Accredits hospitals and other similar health
       organizations. http://www.jointcommission.org/AboutUs/

     – College of American Pathologists (CAP) Accredits laboratories.
       http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=about
       _cap

     – Commission on Office Laboratory Accreditation (COLA) Accredits
       physician office labs (POLs) http://www.cola.org/
 Unit #1 Introduction to
  Laboratory Medicine
Professional    Organizations
  – American Society for Clinical Laboratory Science
    (ASCLS) http://www.ascls.org/
  – American Association of Blood Banks (AABB)
    http://www.aabb.org/Content/About_AABB/Who_We_Are/
  – American Association of Clinical Chemists (AACC)
    http://www.aacc.org/about/overview/Pages/default.aspx
  - Clinical Laboratory Management Association (CLMA)
    http://www.clma.org/
  - Clinical and Laboratory Standards Institute (CLSI) –
    sets standards for clinical laboratory testing and
    identifies best practices; formerly NCCLS
    http://www.clsi.org/
      Unit #1 Introduction to
       Laboratory Medicine
 Confidentiality
  – As a member of the health care team, it is
    expected that we will always respect the
    privacy of our patients.
  – This includes not talking about our patients,
    their diagnosis or prognosis, or their test
    results to anybody except those that have
    ”a right to know”, such as other health care
    professionals working with this patient or
    the parents of a minor child.
    Unit #1 Introduction to
     Laboratory Medicine
– Confidentiality also means that you protect
  the patient’s right to privacy in such areas
  as:
   Keeping  the patient covered to the extent
    possible when the patient cannot do this
    herself.
   Not calling out to patients in doctors’ office
    about the nature of their visit to the doctor or
    their treatment when other patients are in
    earshot.
   Unit #1 Introduction to
    Laboratory Medicine

– The Health Insurance Portability and
  Accountability Act of 1996 (HIPAA, Title
  II) was passed by Congress to address
  patient privacy in the sharing of
  electronic databases, but was expanded to
  include patient privacy in ALL aspects of
  patient care and interaction.
  http://www.cms.hhs.gov/HIPAAGenInfo/
    Unit #1 Introduction to
     Laboratory Medicine
– ALL Austin Community College health
  sciences students are REQUIRED to
  complete the HIPAA Student/Employee
  Training Module. Go to
  http://www.austincc.edu/hipaa/training/
– Click on the HIPAA Student/Employee
  Training Module link and start the module.
– You will be asked to designate the Health
  Sciences program in which you are enrolled.
  Click on Medical Laboratory Technology

								
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