MLAB 1101 Introduction to Clinical Laboratory Science

MLAB 1101MLAB 1101Introduction to Clinical Introduction to Clinical

Laboratory ScienceLaboratory Science

Instructor: Instructor:

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

Unit #1 Introduction to Unit #1 Introduction to Laboratory MedicineLaboratory Medicine

Unit #1 Introduction to Unit #1 Introduction to Laboratory Medicine Laboratory Medicine

A. Definition of Clinical Laboratory A. Definition of Clinical Laboratory Science – Science – A profession concerned with providing A profession concerned with providing information based on the performance of analytical information based on the performance of analytical tests on human body substances to detect evidence of tests on human body substances to detect evidence of or prevent disease or impairment and to promote and or prevent disease or impairment and to promote and

monitor good health.monitor good health. B. Scope of Practice (American B. Scope of Practice (American

Society for Clinical Laboratory Society for Clinical Laboratory Science - ASCLS) – Science - ASCLS) – Assuring reliable test Assuring reliable test results which contribute to the prevention, diagnosis, results which contribute to the prevention, diagnosis, prognosis, and treatment of physiological and prognosis, and treatment of physiological and pathological conditions. pathological conditions.

Unit #1 Introduction to Unit #1 Introduction to Laboratory Medicine Laboratory Medicine

C. Overview of Clinical Laboratory Science ProfessionC. Overview of Clinical Laboratory Science Profession

Read information on the role of the MLT/MLS in the clinical Read information on the role of the MLT/MLS in the clinical laboratory from the American Society for Clinical Pathology:laboratory from the American Society for Clinical Pathology:

http://www.ascp.org/MainMenu/laboratoryprofessionals/CareerCenter.aspxhttp://www.ascp.org/MainMenu/laboratoryprofessionals/CareerCenter.aspx

(See Unit #1 Assignment for further information on this (See Unit #1 Assignment for further information on this website)website)


D. D. History of Clinical Laboratory ScienceHistory of Clinical Laboratory Science– Evidence of blood fluid testing as early as Evidence of blood fluid testing as early as

1500 B.C.1500 B.C.– First clinical lab opened at Johns Hopkins First clinical lab opened at Johns Hopkins

Hospital in 1896 (Baltimore)Hospital in 1896 (Baltimore)– American Society for Clinical Pathology American Society for Clinical Pathology

(ASCP) formed in 1922 (originally named (ASCP) formed in 1922 (originally named “American Society of Clinical Pathologists”)“American Society of Clinical Pathologists”)

– ASCP Board of Registry formed in 1928 to ASCP Board of Registry formed in 1928 to certify clinical laboratory personnelcertify clinical laboratory personnel


D. History of Clinical Laboratory D. History of Clinical Laboratory Science (cont’d)Science (cont’d)– American Society for Clinical Laboratory American Society for Clinical Laboratory

Sciences (ASCLS) formed in 1933 Sciences (ASCLS) formed in 1933 (formerly named “American Society for (formerly named “American Society for Clinical Laboratory Technicians”, Clinical Laboratory Technicians”, “American Society for Medical “American Society for Medical Technologists”, “American Society for Technologists”, “American Society for Medical Technology”)Medical Technology”)

– First autoanalyzer introduced in 1957First autoanalyzer introduced in 1957


D. History of Clinical Laboratory Science D. History of Clinical Laboratory Science (cont’d)(cont’d)– Medicare and Medicaid established in 1960sMedicare and Medicaid established in 1960s– National Credentialing Agency for Laboratory National Credentialing Agency for Laboratory

Personnel (NCA) formed in 1976 by ASCLSPersonnel (NCA) formed in 1976 by ASCLS– Clinical Laboratory Improvement Act in 1988Clinical Laboratory Improvement Act in 1988– NCA assumed by ASCP on October 23, 2009NCA assumed by ASCP on October 23, 2009


E. Organization of a typical clinical E. Organization of a typical clinical laboratorylaboratory– Located in hospitals, clinics, doctors’ Located in hospitals, clinics, doctors’

group practices, single doctor offices, group practices, single doctor offices, health departments, reference health departments, reference laboratorieslaboratories


– DepartmentsDepartmentsChemistry – body fluid componentsChemistry – body fluid components


Microbiology – pathogenic microorganismsMicrobiology – pathogenic microorganisms


Hematology – whole blood analysis and Hematology – whole blood analysis and coagulationcoagulation


UrinalysisUrinalysis


Blood Bank (Immunohematology) – Blood Bank (Immunohematology) – transfusion related testingtransfusion related testing


Serology (Immunology) – antibody studiesSerology (Immunology) – antibody studies


Specimen Collecting and Processing – Specimen Collecting and Processing – includes phlebotomyincludes phlebotomy


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


– Categories of Test RequestsCategories of Test RequestsRoutineRoutineASAP (as soon as possible)ASAP (as soon as possible)STAT (from Latin word “statim”, meaning STAT (from Latin word “statim”, meaning

“with haste”)“with haste”)Pre-Op (pre-operative)Pre-Op (pre-operative)NPO (from Latin words “non per os”, NPO (from Latin words “non per os”,

meaning “nothing by mouth)meaning “nothing by mouth)pp (or pc) (post-prandial or “after eating”)pp (or pc) (post-prandial or “after eating”)

– pp literally means post-breakfastpp literally means post-breakfast– pc literally means post-mealpc literally means post-meal


G. Educational Requirements for Clinical G. Educational Requirements for Clinical Laboratory PersonnelLaboratory Personnel

– Phlebotomist Phlebotomist High school graduate or equivalentHigh school graduate or equivalent Certification (passing a national proficiency exam) preferredCertification (passing a national proficiency exam) preferred Austin Community College offers Phlebotomy training – visit Austin Community College offers Phlebotomy training – visit

http://www.austincc.edu/health/phb/ or call 223-5918 for http://www.austincc.edu/health/phb/ or call 223-5918 for informationinformation

– Medical Laboratory Technician (MLT-ASCP) Medical Laboratory Technician (MLT-ASCP) Associate’s degree or 1 year certificate Associate’s degree or 1 year certificate Certification requiredCertification required Austin Community College offers MLT Program – visit Austin Community College offers MLT Program – visit

http://www.austincc.edu/health/mlt/ orhttp://www.austincc.edu/health/mlt/ or call 223-5918 for call 223-5918 for informationinformation


– Medical Laboratory Technologist (MLS-ASCP) Medical Laboratory Technologist (MLS-ASCP) Bachelor's degree Bachelor's degree Includes a formal training program Includes a formal training program MLS/CLS training may be:MLS/CLS training may be:

– 3 years general college plus one year hospital internship - U.T. 3 years general college plus one year hospital internship - U.T. Austin offers this type of degree; Austin offers this type of degree; http://www.biosci.utexas.edu/cls/http://www.biosci.utexas.edu/cls/ for information for information

– Associate’s degree in MLT plus two years additional years of Associate’s degree in MLT plus two years additional years of professional training – U.T.M.B. Galveston offers this type of professional training – U.T.M.B. Galveston offers this type of degree; degree; http://sahs.utmb.edu/cls/http://sahs.utmb.edu/cls/ for information for information

– Completion of bachelor’s degree and one year hospital Completion of bachelor’s degree and one year hospital internship –Austin State Hospital offers this type of internship; internship –Austin State Hospital offers this type of internship; http://www.dshs.state.tx.us/mhhospitals/AustinSH/ResMedTech.http://www.dshs.state.tx.us/mhhospitals/AustinSH/ResMedTech.shtmshtm for information for information

– 4 years college, which includes professional training and 4 years college, which includes professional training and hospital internship – Texas State University offers this type of hospital internship – Texas State University offers this type of degree; degree; http://www.health.txstate.edu/cls/http://www.health.txstate.edu/cls/ for information for information


– Specialists – Requires MLS and several years Specialists – Requires MLS and several years of documented experience, plus certification of documented experience, plus certification through ASCP (examples: SBB = Specialist in through ASCP (examples: SBB = Specialist in Blood Bank, SH = Specialist in Hematology, Blood Bank, SH = Specialist in Hematology, SM = Specialist in Microbiology, etc.)SM = Specialist in Microbiology, etc.)

– Pathologist – M.D. (4 years college and 4 Pathologist – M.D. (4 years college and 4 years medical school) + 4-5 years of years medical school) + 4-5 years of residency training in pathologyresidency training in pathology May be certified in:May be certified in:

– Anatomical Pathology (AP) and/or Anatomical Pathology (AP) and/or – Clinical Pathology (CP)Clinical Pathology (CP)


H. Clinical Laboratory Improvement H. Clinical Laboratory Improvement Act of 1988 (CLIA ’88)Act of 1988 (CLIA ’88)– http://www.cms.hhs.gov/clia/http://www.cms.hhs.gov/clia/– Actually implemented on Sept. 1, 1992Actually implemented on Sept. 1, 1992– Divides all clinical labs into Divides all clinical labs into “waived”,“waived”,

“moderately complex”,“moderately complex”, and and “highly “highly complex”complex” categories categories


Waived laboratoriesWaived laboratories– Perform tests that are so simple and accurate as Perform tests that are so simple and accurate as

to render the likelihood of errors of results to render the likelihood of errors of results negligiblenegligible

– Have no certification or education requirements Have no certification or education requirements for testing personnelfor testing personnel

– Do not require proficiency testing (external Do not require proficiency testing (external comparison of laboratory quality control)comparison of laboratory quality control)

– Waived tests include tests listed on Waived tests include tests listed on http://www.cms.hhs.gov/clia/http://www.cms.hhs.gov/clia/ under under “Categorization of Tests” on left side of web page“Categorization of Tests” on left side of web page


Moderately ComplexModerately Complex– Mainly manual procedures with limited steps and Mainly manual procedures with limited steps and

preparation and automated analyses that do not preparation and automated analyses that do not require operator intervention during the analytical require operator intervention during the analytical process process

– Requires proficiency testing. If lab fails, it can be Requires proficiency testing. If lab fails, it can be prevented from doing the analyte failed. prevented from doing the analyte failed.

– Testing personnel must have a minimum of high Testing personnel must have a minimum of high school graduation plus completion of 50 weeks of school graduation plus completion of 50 weeks of military training or other appropriate documented military training or other appropriate documented trainingtraining


Highly ComplexHighly Complex– Designation for labs that perform ALL laboratory Designation for labs that perform ALL laboratory

testing, including highly specializedtesting, including highly specialized– Requires extensive proficiency testingRequires extensive proficiency testing– Testing personnel must have at least an Testing personnel must have at least an

associate’s degree in a laboratory scienceassociate’s degree in a laboratory science


Governmental Agencies that regulate Governmental Agencies that regulate the roles of clinical laboratories (all the roles of clinical laboratories (all are within the Department of Health are within the Department of Health and Human Services – HHS – which is and Human Services – HHS – which is charged with safeguarding the health charged with safeguarding the health of the public and providing those of the public and providing those health services seemed essential to health services seemed essential to the maintenance of good health)the maintenance of good health)


– CDC (Centers for Disease Control and CDC (Centers for Disease Control and Prevention)Prevention)Monitors disease outbreaks, implements Monitors disease outbreaks, implements

disease prevention strategies, and maintains disease prevention strategies, and maintains national health statisticsnational health statistics

Provides immunization services, workplace Provides immunization services, workplace safety, and environmental disease safety, and environmental disease prevention guidanceprevention guidance

Monitors international disease transmissionMonitors international disease transmissionAdministers the Agency for Toxic Substances Administers the Agency for Toxic Substances

and Disease Registryand Disease Registry


– CMS (Centers for Medicare and Medicaid CMS (Centers for Medicare and Medicaid Services)Services)

Administers Medicare, a federal healthcare Administers Medicare, a federal healthcare coverage plan for the elderly, those with severe coverage plan for the elderly, those with severe kidney damage who require dialysis, and people kidney damage who require dialysis, and people with certain disabilitieswith certain disabilities

Works with states to administer Medicaid, Works with states to administer Medicaid, healthcare coverage for individuals living at or healthcare coverage for individuals living at or below poverty levelsbelow poverty levels

Controls Medicare and Medicaid payment for Controls Medicare and Medicaid payment for medical procedures, including laboratory servicesmedical procedures, including laboratory services

Regulates enforcement for CLIARegulates enforcement for CLIA Enforces the Health Insurance Portability and Enforces the Health Insurance Portability and

Accountability Act of 1996 (HIPAA, Title II) Accountability Act of 1996 (HIPAA, Title II)


– FDA (Food and Drug Administration)FDA (Food and Drug Administration)Monitors safety and effectiveness of food, Monitors safety and effectiveness of food,

drinks, cosmetics, drugs, and medical drinks, cosmetics, drugs, and medical devicesdevices

Determines whether a laboratory test is Determines whether a laboratory test is classified as waived, moderately complex, or classified as waived, moderately complex, or highly complexhighly complex


ProfessionalismProfessionalism– DefinitionsDefinitions

Accreditation – voluntary process in which a Accreditation – voluntary process in which a non-governmental agency grants non-governmental agency grants recognition to recognition to institutions or programsinstitutions or programs that meet or exceed established standards that meet or exceed established standards of quality. Example: MLAB Program at ACC of quality. Example: MLAB Program at ACC is accredited by NAACLS; ACC and other is accredited by NAACLS; ACC and other schools are accredited by SACS; some schools are accredited by SACS; some clinical labs accredited by CAP.clinical labs accredited by CAP.


Registration – a general term referring to the Registration – a general term referring to the voluntary requirement that all voluntary requirement that all persons who persons who engage in a given occupationengage in a given occupation register register with the designated government agency. It with the designated government agency. It does NOT require minimum education or does NOT require minimum education or experience requirements. Examples: experience requirements. Examples: Medical technology in the state of TexasMedical technology in the state of Texas


Certification – a process by which an Certification – a process by which an individual or institutionindividual or institution is evaluated and is evaluated and recognized as meeting certain predetermined recognized as meeting certain predetermined standards. Usually non-government and standards. Usually non-government and voluntary. Examples: ASCP exam for medical voluntary. Examples: ASCP exam for medical technologytechnology

Licensure – often referred to as a “practice Licensure – often referred to as a “practice act”. act”. Not voluntaryNot voluntary. The granting of . The granting of permission by an authority (usually a state) to permission by an authority (usually a state) to an an individual or organizationindividual or organization in some in some practice or activity. Examples: State practice or activity. Examples: State licensure for physicians, nurses (NOTE: Texas licensure for physicians, nurses (NOTE: Texas does NOT require licensure for clinical does NOT require licensure for clinical laboratory professions!)laboratory professions!)


Continuing Education – professionalism Continuing Education – professionalism includes continuing your education after includes continuing your education after graduation/certification. Technology and graduation/certification. Technology and medical research move at lightning speed, medical research move at lightning speed, and it is VITAL for all health professionals to and it is VITAL for all health professionals to keep up with changes and developments in keep up with changes and developments in their fields. ASCP REQUIRES continuing their fields. ASCP REQUIRES continuing education in order to maintain certification. education in order to maintain certification. ASCP offers a free Maintenance Certification ASCP offers a free Maintenance Certification Program for members to keep track of Program for members to keep track of continuing education continuing education http://tinyurl.com/l32gkfhttp://tinyurl.com/l32gkf


– Certification and Accrediting Agencies Certification and Accrediting Agencies and Professional Organizationsand Professional OrganizationsCertification AgenciesCertification Agencies

– American Society of Clinical Pathologists (ASCP) – American Society of Clinical Pathologists (ASCP) – Board of Registry (BOR) established in 1928 Board of Registry (BOR) established in 1928 http://www.ascp.org/FunctionalNavigation/certification.aspxhttp://www.ascp.org/FunctionalNavigation/certification.aspx

– American Medical Technologist (AMT) – 1939 American Medical Technologist (AMT) – 1939 http://www.amt1.com/http://www.amt1.com/

– American Association of Bioanalysts (AAB) Board American Association of Bioanalysts (AAB) Board of Registry 1999 (Formerly called International of Registry 1999 (Formerly called International Society for Clinical Laboratory Technology ISCLT Society for Clinical Laboratory Technology ISCLT – 1962) – 1962) http://www.aab.org/aab/American_Board_of_Bioanalysis.asphttp://www.aab.org/aab/American_Board_of_Bioanalysis.asp


Accreditation AgenciesAccreditation Agencies– National Accreditation Agency for Clinical Laboratory Sciences National Accreditation Agency for Clinical Laboratory Sciences

(NAACLS) – 1973 http://www.naacls.org/(NAACLS) – 1973 http://www.naacls.org/

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

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

– Commission on Office Laboratory Accreditation (COLA) Commission on Office Laboratory Accreditation (COLA) Accredits physician office labs (POLs) http://www.cola.org/Accredits physician office labs (POLs) http://www.cola.org/


Professional Organizations Professional Organizations – American Society for Clinical Laboratory Science American Society for Clinical Laboratory Science

(ASCLS) http://www.ascls.org/(ASCLS) http://www.ascls.org/– American Association of Blood Banks (AABB) American Association of Blood Banks (AABB)

http://www.aabb.org/Content/About_AABB/Who_We_Are/http://www.aabb.org/Content/About_AABB/Who_We_Are/

– American Association of Clinical Chemists (AACC)American Association of Clinical Chemists (AACC)http://www.aacc.org/about/overview/Pages/default.aspxhttp://www.aacc.org/about/overview/Pages/default.aspx

- Clinical Laboratory Management Association Clinical Laboratory Management Association (CLMA) (CLMA) http://www.clma.org/http://www.clma.org/

- Clinical and Laboratory Standards Institute (CLSI) Clinical and Laboratory Standards Institute (CLSI) – sets standards for clinical laboratory testing and – sets standards for clinical laboratory testing and identifies best practices; formerly NCCLS identifies best practices; formerly NCCLS http://www.clsi.org/http://www.clsi.org/


ConfidentialityConfidentiality– As a member of the health care team, it As a member of the health care team, it

is expected that we will always respect is expected that we will always respect the privacy of our patients.the privacy of our patients.

– This includes not talking about our This includes not talking about our patients, their diagnosis or prognosis, or patients, their diagnosis or prognosis, or their test results to anybody except their test results to anybody except those that have ”a right to know”, such those that have ”a right to know”, such as other health care professionals as other health care professionals working with this patient or the parents working with this patient or the parents of a minor child.of a minor child.


– Confidentiality also means that you Confidentiality also means that you protect the patient’s right to privacy in protect the patient’s right to privacy in such areas as:such areas as:Keeping the patient covered to the extent Keeping the patient covered to the extent

possible when the patient cannot do this possible when the patient cannot do this herself.herself.

Not calling out to patients in doctors’ office Not calling out to patients in doctors’ office about the nature of their visit to the doctor about the nature of their visit to the doctor or their treatment when other patients are in or their treatment when other patients are in earshot.earshot.


– The Health Insurance Portability and The Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title Accountability Act of 1996 (HIPAA, Title II) was passed by Congress to address II) was passed by Congress to address patient privacy in the sharing of patient privacy in the sharing of electronic databases, but was electronic databases, but was expanded to include patient privacy in expanded to include patient privacy in ALL aspects of patient care and ALL aspects of patient care and interaction. interaction. http://www.cms.hhs.gov/HIPAAGenInfo/http://www.cms.hhs.gov/HIPAAGenInfo/


– ALL Austin Community College health ALL Austin Community College health sciences students are REQUIRED to sciences students are REQUIRED to complete the HIPAA Student/Employee complete the HIPAA Student/Employee Training Module. Go to Training Module. Go to http://http://www.austincc.edu/hipaa/trainingwww.austincc.edu/hipaa/training//

– Click on the HIPAA Student/Employee Click on the HIPAA Student/Employee Training Module link and start the module. Training Module link and start the module.

– You will be asked to designate the Health You will be asked to designate the Health Sciences program in which you are Sciences program in which you are enrolled. Click on Medical Laboratory enrolled. Click on Medical Laboratory TechnologyTechnology

Documents

MLAB 1101 Introduction to Clinical Laboratory Science