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 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.

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 Blood Bank (Immunohematology) – transfusion related testing

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

Unit #1 Introduction to Laboratory Medicine Specimen Collecting 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.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

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