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MLAB 1101 Introduction to Clinical Laboratory Science

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Title: MLAB 1101 Introduction to Clinical Laboratory Science


1
MLAB 1101Introduction to Clinical Laboratory
Science
  • Instructor
  • Cecile Sanders, M.Ed., MT(ASCP),
  • CLS (NCA)

2
Unit 1 Introduction to Laboratory Medicine
3
Unit 1 Introduction to Laboratory Medicine
  • A. Definition of Clinical Laboratory 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.
  • B. Scope of Practice (American Society for
    Clinical Laboratory Science - ASCLS) Assuring
    reliable test results which contribute to the
    prevention, diagnosis, prognosis, and treatment
    of physiological and pathological conditions.

4
Unit 1 Introduction to Laboratory Medicine
  • C. Overview of Clinical Laboratory Science
    Profession
  • Read information on the role of the MLT/MT in
    the clinical laboratory from the American Society
    for Clinical Pathology
  • http//www.ascp.org/MainMenu/laboratoryprofession
    als/CareerCenter.aspx
  • (See Unit 1 Assignment for further information
    on this website)

5
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

6
Unit 1 Introduction to Laboratory Medicine
  • D. History of Clinical Laboratory Science
    (contd)
  • 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

7
Unit 1 Introduction to Laboratory Medicine
  • D. History of Clinical Laboratory Science
    (contd)
  • Medicare and Medicaid established in 1960s
  • National Credentialing Agency for Laboratory
    Personnel (NCA) formed in 1976 by ASCLS
  • Clinical Laboratory Improvement Act in 1988

8
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

9
Unit 1 Introduction to Laboratory Medicine
  • Departments
  • Chemistry body fluid components

10
Unit 1 Introduction to Laboratory Medicine
  • Microbiology pathogenic microorganisms

11
Unit 1 Introduction to Laboratory Medicine
  • Hematology whole blood analysis and coagulation

12
Unit 1 Introduction to Laboratory Medicine
  • Urinalysis

13
Unit 1 Introduction to Laboratory Medicine
  • Blood Bank (Immunohematology) transfusion
    related testing

14
Unit 1 Introduction to Laboratory Medicine
  • Serology (Immunology) antibody studies

15
Unit 1 Introduction to Laboratory Medicine
  • Specimen Collecting and Processing includes
    phlebotomy

16
Unit 1 Introduction to Laboratory Medicine
  • F. Requesting a Laboratory Test
  • Only a physician can order a lab test

17
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

18
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/ph
    b/ or call 223-5918 for information
  • Medical Laboratory Technician (MLT-ASCP) or
    Clinical Laboratory Technician (CLT)
  • Associates 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

19
Unit 1 Introduction to Laboratory Medicine
  • Medical Laboratory Technologist (MT-ASCP) or
    Clinical Laboratory Scientist (CLS)
  • Bachelor's degree
  • Includes a formal training program
  • MT/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
  • Associates 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 bachelors degree and one year
    hospital internship Austin State Hospital offers
    this type of internship http//www.dshs.state.tx.
    us/mhhospitals/AustinSH/ResMedTech.shtm 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

20
Unit 1 Introduction to Laboratory Medicine
  • Specialists Requires MT or CLS and several
    years of documented experience, plus
    certification through ASCP or NCA (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)

21
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

22
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

23
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

24
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
    associates degree in a laboratory science

25
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)

26
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

27
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)

28
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

29
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.

30
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

31
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 or
    NCA exams 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

32
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/certifica
    tion.aspx
  • National Accreditation Agency for Laboratory
    Personnel (NCA) established 1977
    http//www.nca-info.org/

33
Unit 1 Introduction to Laboratory Medicine
  • 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/about20bor.htm
  • Accreditation Agencies
  • National Accreditation Agency for Clinical
    Laboratory Sciences (NAACLS) 1973
    http//www.amt1.com/

34
Unit 1 Introduction to Laboratory Medicine
  • 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?_
    nfpbtrue_pageLabelabout_cap
  • Commission on Office Laboratory Accreditation
    (COLA) Accredits physician office labs (POLs)
    http//www.cola.org/

35
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/main.aspx?saboutt1default
  • Clinical and Laboratory Standards Institute
    (CLSI) sets standards for clinical laboratory
    testing and identifies best practices formerly
    NCCLS http//webstore.ansi.org/ansidocstore/dept.
    asp?dept_id57

36
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.

37
Unit 1 Introduction to Laboratory Medicine
  • Confidentiality also means that you protect the
    patients 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.

38
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/

39
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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