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/pdf/TheMedicalTechnologistandMedicalLa
boratoryTechnician.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
coagulation
– whole blood analysis and
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://tinyurl.com/7hoyypp
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.s
htm 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://www.ascp.org/Board-of-Certification
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://tinyurl.com/pxkgz5w
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/
hipaa_home.php
– 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