Intro to Laboratory Medicine

MLAB 1101MLAB 1101
Introduction to ClinicalIntroduction to Clinical
Laboratory ScienceLaboratory Science
Instructor:Instructor:
Cecile Sanders, M.Ed.,Cecile Sanders, M.Ed.,
MLS(ASCP)MLS(ASCP)

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

 A. Definition of Clinical LaboratoryA. Definition of Clinical Laboratory
Science –Science – A profession concerned with providingA profession concerned with providing
information based on the performance of analytical testsinformation based on the performance of analytical tests
on human body substances to detect evidence of oron human body substances to detect evidence of or
prevent disease or impairment and to promote and monitorprevent disease or impairment and to promote and monitor
good health.good health.
 B. Scope of Practice (American SocietyB. Scope of Practice (American Society
for Clinical Laboratory Science -for Clinical Laboratory Science -
ASCLS) –ASCLS) – Assuring reliable test results whichAssuring reliable test results which
contribute to the prevention, diagnosis, prognosis, andcontribute to the prevention, diagnosis, prognosis, and
treatment of physiological and pathological conditions.treatment of physiological and pathological conditions.

 C. Overview of Clinical Laboratory Science ProfessionC. Overview of Clinical Laboratory Science Profession
Read information on the role of the MLT/MLS in the clinicalRead 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 LaboratoryHistory of Clinical Laboratory
ScienceScience
– Evidence of blood fluid testing as early asEvidence of blood fluid testing as early as
1500 B.C.1500 B.C.
– First clinical lab opened at Johns HopkinsFirst clinical lab opened at Johns Hopkins
Hospital in 1896 (Baltimore)Hospital in 1896 (Baltimore)
– American Society for Clinical PathologyAmerican 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 toASCP Board of Registry formed in 1928 to
certify clinical laboratory personnelcertify clinical laboratory personnel

 D. History of Clinical LaboratoryD. History of Clinical Laboratory
Science (cont’d)Science (cont’d)
– American Society for Clinical LaboratoryAmerican Society for Clinical Laboratory
Sciences (ASCLS) formed in 1933Sciences (ASCLS) formed in 1933
(formerly named “American Society for(formerly named “American Society for
Clinical Laboratory Technicians”, “AmericanClinical Laboratory Technicians”, “American
Society for Medical Technologists”,Society for Medical Technologists”,
“American Society for Medical“American Society for Medical
Technology”)Technology”)
– First autoanalyzer introduced in 1957First autoanalyzer introduced in 1957

 D. History of Clinical Laboratory ScienceD. History of Clinical Laboratory Science
(cont’d)(cont’d)
– Medicare and Medicaid established in 1960sMedicare and Medicaid established in 1960s
– National Credentialing Agency for LaboratoryNational 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 clinicalE. Organization of a typical clinical
laboratorylaboratory
– Located in hospitals, clinics, doctors’ groupLocated in hospitals, clinics, doctors’ group
practices, single doctor offices, healthpractices, single doctor offices, health
departments, reference laboratoriesdepartments, reference laboratories

– DepartmentsDepartments
Chemistry – body fluid componentsChemistry – body fluid components

Microbiology – pathogenic microorganismsMicrobiology – pathogenic microorganisms

Hematology – whole blood analysis andHematology – whole blood analysis and
coagulationcoagulation

UrinalysisUrinalysis

Blood Bank (Immunohematology) – transfusionBlood Bank (Immunohematology) – transfusion
related testingrelated testing

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

Specimen Collecting and Processing – includesSpecimen Collecting and Processing – includes
phlebotomyphlebotomy

 F. Requesting a Laboratory TestF. 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 Requests
RoutineRoutine
ASAP (as soon as possible)ASAP (as soon as possible)
STAT (from Latin word “statim”, meaning “withSTAT (from Latin word “statim”, meaning “with
haste”)haste”)
Pre-Op (pre-operative)Pre-Op (pre-operative)
NPO (from Latin words “non per os”, meaningNPO (from Latin words “non per os”, meaning
“nothing by mouth)“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 LaboratoryG. Educational Requirements for Clinical Laboratory
PersonnelPersonnel
– PhlebotomistPhlebotomist
 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 – visitAustin Community College offers Phlebotomy training – visit
http://www.austincc.edu/health/phb/ or call 223-5918 forhttp://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 certificateAssociate’s degree or 1 year certificate
 Certification requiredCertification required
 Austin Community College offers MLT Program – visitAustin Community College offers MLT Program – visit
http://www.austincc.edu/health/mlt/ orhttp://www.austincc.edu/health/mlt/ or call 223-5918 forcall 223-5918 for
informationinformation

– Medical Laboratory Technologist (MLS-ASCP)Medical Laboratory Technologist (MLS-ASCP)
 Bachelor's degreeBachelor's degree
 Includes a formal training programIncludes 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 informationfor information
– Associate’s degree in MLT plus two years additional years ofAssociate’s degree in MLT plus two years additional years of
professional training – U.T.M.B. Galveston offers this type ofprofessional training – U.T.M.B. Galveston offers this type of
degree;degree; http://sahs.utmb.edu/cls/http://sahs.utmb.edu/cls/ for informationfor information
– Completion of bachelor’s degree and one year hospital internship –Completion of bachelor’s degree and one year hospital internship –
Austin State Hospital offers this type of internship;Austin State Hospital offers this type of internship;
http://www.dshs.state.tx.us/mhhospitals/AustinSH/ResMedTech.shtmhttp://www.dshs.state.tx.us/mhhospitals/AustinSH/ResMedTech.shtm
for informationfor information
– 4 years college, which includes professional training and hospital4 years college, which includes professional training and hospital
internship – Texas State University offers this type of degree;internship – Texas State University offers this type of degree;
http://www.health.txstate.edu/cls/http://www.health.txstate.edu/cls/ for informationfor information

– Specialists – Requires MLS and several years ofSpecialists – Requires MLS and several years of
documented experience, plus certificationdocumented experience, plus certification
through ASCP (examples: SBB = Specialist inthrough ASCP (examples: SBB = Specialist in
Blood Bank, SH = Specialist in Hematology, SM =Blood Bank, SH = Specialist in Hematology, SM =
Specialist in Microbiology, etc.)Specialist in Microbiology, etc.)
– Pathologist – M.D. (4 years college and 4 yearsPathologist – M.D. (4 years college and 4 years
medical school) + 4-5 years of residency trainingmedical school) + 4-5 years of residency training
in pathologyin pathology
 May be certified in:May be certified in:
– Anatomical Pathology (AP) and/orAnatomical Pathology (AP) and/or
– Clinical Pathology (CP)Clinical Pathology (CP)

 H. Clinical Laboratory Improvement ActH. Clinical Laboratory Improvement Act
of 1988 (CLIA ’88)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 intoDivides all clinical labs into “waived”,“waived”,
“moderately complex”,“moderately complex”, andand “highly“highly
complex”complex” categoriescategories

Waived laboratoriesWaived laboratories
– Perform tests that are so simple and accurate as toPerform tests that are so simple and accurate as to
render the likelihood of errors of results negligiblerender the likelihood of errors of results negligible
– Have no certification or education requirements forHave no certification or education requirements for
testing personneltesting personnel
– Do not require proficiency testing (externalDo not require proficiency testing (external
comparison of laboratory quality control)comparison of laboratory quality control)
– Waived tests include tests listed onWaived tests include tests listed on
http://www.cms.hhs.gov/clia/http://www.cms.hhs.gov/clia/ under “Categorizationunder “Categorization
of Tests” on left side of web pageof Tests” on left side of web page

Moderately ComplexModerately Complex
– Mainly manual procedures with limited steps andMainly manual procedures with limited steps and
preparation and automated analyses that do notpreparation and automated analyses that do not
require operator intervention during the analyticalrequire operator intervention during the analytical
processprocess
– Requires proficiency testing. If lab fails, it can beRequires 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 schoolTesting personnel must have a minimum of high school
graduation plus completion of 50 weeks of militarygraduation plus completion of 50 weeks of military
training or other appropriate documented trainingtraining or other appropriate documented training

Highly ComplexHighly Complex
– Designation for labs that perform ALL laboratoryDesignation 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 associate’sTesting personnel must have at least an associate’s
degree in a laboratory sciencedegree in a laboratory science

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

– CDC (Centers for Disease Control andCDC (Centers for Disease Control and
Prevention)Prevention)
Monitors disease outbreaks, implements diseaseMonitors disease outbreaks, implements disease
prevention strategies, and maintains nationalprevention strategies, and maintains national
health statisticshealth statistics
Provides immunization services, workplaceProvides immunization services, workplace
safety, and environmental disease preventionsafety, and environmental disease prevention
guidanceguidance
Monitors international disease transmissionMonitors international disease transmission
Administers the Agency for Toxic SubstancesAdministers the Agency for Toxic Substances
and Disease Registryand Disease Registry

– CMS (Centers for Medicare and MedicaidCMS (Centers for Medicare and Medicaid
Services)Services)
 Administers Medicare, a federal healthcareAdministers Medicare, a federal healthcare
coverage plan for the elderly, those with severecoverage plan for the elderly, those with severe
kidney damage who require dialysis, and people withkidney damage who require dialysis, and people with
certain disabilitiescertain disabilities
 Works with states to administer Medicaid,Works with states to administer Medicaid,
healthcare coverage for individuals living at or belowhealthcare coverage for individuals living at or below
poverty levelspoverty levels
 Controls Medicare and Medicaid payment for medicalControls Medicare and Medicaid payment for medical
procedures, including laboratory servicesprocedures, including laboratory services
 Regulates enforcement for CLIARegulates enforcement for CLIA
 Enforces the Health Insurance Portability andEnforces 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 devicesdrinks, cosmetics, drugs, and medical devices
Determines whether a laboratory test isDetermines whether a laboratory test is
classified as waived, moderately complex, orclassified as waived, moderately complex, or
highly complexhighly complex

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

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

Certification – a process by which anCertification – a process by which an individualindividual
or institutionor institution is evaluated and recognized asis evaluated and recognized as
meeting certain predetermined standards.meeting certain predetermined standards.
Usually non-government and voluntary.Usually non-government and voluntary.
Examples: ASCP exam for medical technologyExamples: ASCP exam for medical technology
Licensure – often referred to as a “practiceLicensure – often referred to as a “practice
act”.act”. Not voluntaryNot voluntary. The granting of. The granting of
permission by an authority (usually a state) topermission by an authority (usually a state) to
anan individual or organizationindividual or organization in some practice orin some practice or
activity. Examples: State licensure foractivity. Examples: State licensure for
physicians, nurses (NOTE: Texas does NOTphysicians, nurses (NOTE: Texas does NOT
require licensure for clinical laboratoryrequire licensure for clinical laboratory
professions!)professions!)

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

– Certification and Accrediting Agencies andCertification and Accrediting Agencies and
Professional OrganizationsProfessional Organizations
Certification AgenciesCertification Agencies
– American Society of Clinical Pathologists (ASCP) –American Society of Clinical Pathologists (ASCP) –
Board of Registry (BOR) established in 1928Board of Registry (BOR) established in 1928
http://www.ascp.org/FunctionalNavigation/certification.aspxhttp://www.ascp.org/FunctionalNavigation/certification.aspx
– American Medical Technologist (AMT) – 1939American Medical Technologist (AMT) – 1939
http://www.amt1.com/http://www.amt1.com/
– American Association of Bioanalysts (AAB) Board ofAmerican Association of Bioanalysts (AAB) Board of
Registry 1999 (Formerly called International SocietyRegistry 1999 (Formerly called International Society
for Clinical Laboratory Technology ISCLTfor 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 SciencesNational Accreditation Agency for Clinical Laboratory Sciences
(NAACLS) – 1973 http://www.naacls.org/(NAACLS) – 1973 http://www.naacls.org/
– Joint Commission on Accreditation of Healthcare OrganizationsJoint 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) AccreditsCommission on Office Laboratory Accreditation (COLA) Accredits
physician office labs (POLs) http://www.cola.org/physician office labs (POLs) http://www.cola.org/

Professional OrganizationsProfessional Organizations
– American Society for Clinical Laboratory ScienceAmerican 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 (CLMA)Clinical Laboratory Management Association (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 andsets standards for clinical laboratory testing and
identifies best practices; formerly NCCLSidentifies best practices; formerly NCCLS
http://www.clsi.org/http://www.clsi.org/

 ConfidentialityConfidentiality
– As a member of the health care team, it isAs a member of the health care team, it is
expected that we will always respect theexpected that we will always respect the
privacy of our patients.privacy of our patients.
– This includes not talking about our patients,This includes not talking about our patients,
their diagnosis or prognosis, or their testtheir diagnosis or prognosis, or their test
results to anybody except those that haveresults to anybody except those that have
”a right to know”, such as other health care”a right to know”, such as other health care
professionals working with this patient orprofessionals working with this patient or
the parents of a minor child.the parents of a minor child.

– Confidentiality also means that you protectConfidentiality also means that you protect
the patient’s right to privacy in such areasthe patient’s right to privacy in such areas
as:as:
Keeping the patient covered to the extentKeeping the patient covered to the extent
possible when the patient cannot do thispossible when the patient cannot do this
herself.herself.
Not calling out to patients in doctors’ officeNot calling out to patients in doctors’ office
about the nature of their visit to the doctor orabout the nature of their visit to the doctor or
their treatment when other patients are intheir treatment when other patients are in
earshot.earshot.

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

– ALL Austin Community College healthALL Austin Community College health
sciences students are REQUIRED tosciences students are REQUIRED to
complete the HIPAA Student/Employeecomplete the HIPAA Student/Employee
Training Module. Go toTraining Module. Go to http://http://
www.austincc.edu/hipaa/trainingwww.austincc.edu/hipaa/training//
– Click on the HIPAA Student/EmployeeClick 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 HealthYou will be asked to designate the Health
Sciences program in which you are enrolled.Sciences program in which you are enrolled.
Click on Medical Laboratory TechnologyClick on Medical Laboratory Technology

Intro to Laboratory Medicine

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