CLS Final Exam Questions & Answers
2024/2025
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. - ANSWERSClinical Lab
Science/MLS
The branch of medicine that contributes to diagnosis, prognosis, and treatment of disease through lab
applications. - ANSWERSPathology
The medical discipline in which diseases are diagnosed by examination of surgical tissue and through
autopsy. - ANSWERSAnatomical Pathology
The medical discipline in which clinical lab science and technology are applied to the care of patients. -
ANSWERSClinical Pathology
A process of establishing the qualifications of individuals and organizations meeting acceptable training
education standards. - ANSWERSCredentialing
Process by which a non-governmental agency or association grants recognition of competence to an
individual who has met predetermined qualifications. - ANSWERSCertification
Enacted by legislation on a state level to protect the public, control the entrance into the professional
practice enforcement of standards of practice. - ANSWERSLicensure
Approval program of training by an appropriate agency. - ANSWERSAccreditation
Evaluates school/education programs by site visits, a self-study report done by the Program Director, and
interviews with students. - ANSWERSNAACLS
, 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. - ANSWERSCLIA 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. - ANSWERSQuality Assessment (QA) Program
What are the four components of the Quality Assessment Program? - ANSWERSRecord 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 - ANSWERSQuality Control
What are the three CLIA 88' testing levels? - ANSWERSWaived 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) - ANSWERSWaived Tests
More complex than waived tests, but usually are automated (CBC, Urine Drug Screen) -
ANSWERSModerately Complex Tests
Usually are non-automated or complicated tests requiring considerable judgement (molecular
diagnostics tests, cross-match in blood bank) - ANSWERSHigh 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? - ANSWERSPre-analytical, Analytical, Post-analytical.
2024/2025
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. - ANSWERSClinical Lab
Science/MLS
The branch of medicine that contributes to diagnosis, prognosis, and treatment of disease through lab
applications. - ANSWERSPathology
The medical discipline in which diseases are diagnosed by examination of surgical tissue and through
autopsy. - ANSWERSAnatomical Pathology
The medical discipline in which clinical lab science and technology are applied to the care of patients. -
ANSWERSClinical Pathology
A process of establishing the qualifications of individuals and organizations meeting acceptable training
education standards. - ANSWERSCredentialing
Process by which a non-governmental agency or association grants recognition of competence to an
individual who has met predetermined qualifications. - ANSWERSCertification
Enacted by legislation on a state level to protect the public, control the entrance into the professional
practice enforcement of standards of practice. - ANSWERSLicensure
Approval program of training by an appropriate agency. - ANSWERSAccreditation
Evaluates school/education programs by site visits, a self-study report done by the Program Director, and
interviews with students. - ANSWERSNAACLS
, 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. - ANSWERSCLIA 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. - ANSWERSQuality Assessment (QA) Program
What are the four components of the Quality Assessment Program? - ANSWERSRecord 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 - ANSWERSQuality Control
What are the three CLIA 88' testing levels? - ANSWERSWaived 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) - ANSWERSWaived Tests
More complex than waived tests, but usually are automated (CBC, Urine Drug Screen) -
ANSWERSModerately Complex Tests
Usually are non-automated or complicated tests requiring considerable judgement (molecular
diagnostics tests, cross-match in blood bank) - ANSWERSHigh 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? - ANSWERSPre-analytical, Analytical, Post-analytical.
