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The branch of medicine concerned with the performance of lab determinations and analysis
used in the diagnosis and treatment of disease and in the maintenance of health. ✔Correct
Answer-Clinical Lab Science/MLS
The branch of medicine that contributes to diagnosis, prognosis, and treatment of disease
through lab applications. ✔Correct Answer-Pathology
The medical discipline in which diseases are diagnosed by examination of surgical tissue and
through autopsy. ✔Correct Answer-Anatomical Pathology
The medical discipline in which clinical lab science and technology are applied to the care of
patients. ✔Correct Answer-Clinical Pathology
A process of establishing the qualifications of individuals and organizations meeting acceptable
training education standards. ✔Correct Answer-Credentialing
Process by which a non-governmental agency or association grants recognition of competence
to an individual who has met predetermined qualifications. ✔Correct Answer-Certification
Enacted by legislation on a state level to protect the public, control the entrance into the
professional practice enforcement of standards of practice. ✔Correct Answer-Licensure
Approval program of training by an appropriate agency. ✔Correct Answer-Accreditation
Evaluates school/education programs by site visits, a self-study report done by the Program
Director, and interviews with students. ✔Correct Answer-NAACLS
The Clinical Lab Regulation Act ensures high quality of lab results regardless of where the testing
is performed, proficiency testing programs, management of patient testing, Lab procedure
manuals, quality assessment program, and Quality control guidelines and proper
documentation of all pre-analytical, analytical, and post-analytical procedures. ✔Correct
Answer-CLIA 88'
Plant to carry out policies and practices necessary to make certain that lab results are reliable
and that theses results are used to the best interest of the patient. ✔Correct Answer-Quality
Assessment (QA) Program
What are the four components of the Quality Assessment Program? ✔Correct Answer-Record
Keeping, Maintenance of equipment, proficiency testing and training, Quality Control.
, Set of lab procedures designed to ensure that a test method is working properly and that the
results meet the diagnostic needs of the physician.
-Makes use of control specimens
-Can be internal or external
-Check systems of the QA program ✔Correct Answer-Quality Control
What are the three CLIA 88' testing levels? ✔Correct Answer-Waived Tests, Moderately
Complex Tests, Highly Complex Tests.
Simple procedures with little chance of negative outcomes if performed inaccurately; cleared by
the FDA for home use (point of care tests > Glucose, urine pregnancy tests) ✔Correct Answer-
Waived Tests
More complex than waived tests, but usually are automated (CBC, Urine Drug Screen)
✔Correct Answer-Moderately Complex Tests
Usually are non-automated or complicated tests requiring considerable judgement (molecular
diagnostics tests, cross-match in blood bank) ✔Correct Answer-High Complex Tests
What are the three testing levels for the total testing process (TTP) that serves as the primary
point of reference for focusing on quality? ✔Correct Answer-Pre-analytical, Analytical, Post-
analytical.
Patient variables, Specimen Variables (collection, handling and processing) ... Most error prone.
✔Correct Answer-Pre-Analytical
Focus on the performance and accuracy of a selected lab test. ✔Correct Answer-Analytical
Test Reporting variables (recording, reporting, and interpreting) ✔Correct Answer-Post-
Analytical
A system or philosophy of conduct and principles practiced by a person or group; uses reason
and logic to analyze problems and to find solutions. ✔Correct Answer-Ethics
A branch of ethical inquiry that examines the nature of biological and technological advances
such as maintaining patient confidentiality, Maintaining accuracy and reliability in our work,
ensure the best possible healthcare to society. ✔Correct Answer-Bioethics
What is the Three-step ethics model? ✔Correct Answer--Is it legal?
-Is it Balanced?
-How does it make me feel?