MLAB 1101 Introduction to Clinical Laboratory Science

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MLAB 1101Introduction to Clinical Laboratory
Science

• Instructor
• Cecile Sanders, M.Ed., MLS(ASCP)

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Unit 1 Introduction to Laboratory Medicine
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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.

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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/pdf/TheMedicalTechnologistand
  MedicalLaboratoryTechnician.aspx
• (See Unit 1 Assignment for further information
  on this website)

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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

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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

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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
• NCA assumed by ASCP on October 23, 2009

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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

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Unit 1 Introduction to Laboratory Medicine

• Departments
• Chemistry body fluid components

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Unit 1 Introduction to Laboratory Medicine

• Microbiology pathogenic microorganisms

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Unit 1 Introduction to Laboratory Medicine

• Hematology whole blood analysis and coagulation

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Unit 1 Introduction to Laboratory Medicine

• Urinalysis

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Unit 1 Introduction to Laboratory Medicine

• Blood Bank (Immunohematology) transfusion
  related testing

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Unit 1 Introduction to Laboratory Medicine

• Serology (Immunology) antibody studies

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Unit 1 Introduction to Laboratory Medicine

• Specimen Collecting and Processing includes
  phlebotomy

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Unit 1 Introduction to Laboratory Medicine

• F. Requesting a Laboratory Test
• Only a physician can order a lab test

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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

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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)
• 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

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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//tinyurl.com/7hoyypp
• 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

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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)

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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

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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

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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

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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

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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)

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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

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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)

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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

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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.

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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

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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!)

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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//www.ascp.org/Board-of-Certification

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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
• 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

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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?_
  nfpbtrue_pageLabelabout_cap
• Commission on Office Laboratory Accreditation
  (COLA) Accredits physician office labs (POLs)
  http//www.cola.org/

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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/

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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.

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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.

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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/

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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