BOH SOP TEST FINAL TEST 2026
QUESTIONS WITH CORRECT ANSWERS
GRADED A+
◍ All accreditation organizations that can certify the clinical lab.
Answer: AABBAOAASHICOLACAPTJC
◍ What are SOPs?.
Answer: Contained information required to perform a laboratory
testRequired by CLIA
◍ Systematic error.
Answer: BiasError in accuracy, but high precisionConsistently high or low.
Not both
◍ Consequences of unsuccessful PT performance.
Answer: Disqualification to perform the test
◍ What is target value of an external QC established by?.
Answer: Actual valueMean value within peer groupReference method result
value
◍ What needs to be in SOPs?.
Answer: SOP titleReagent informationPrincipleClinical utilityReference
RangeSpecimenInterferencesAnalytical range + reporting
limitProcedureQuality controlCalibrationReagent
preparation/handling/storageReferences
◍ Class II Medical Device.
Answer: Idea is based on pre-existing class III reagentRequires pre-market
data and post-market surveillance, patient registries, performance
standardsEx: A glucose assay has the same reaction as an existing class III
, reagent, but the reaction condition (such as temp or pH) is different
◍ Class III Medical Device.
Answer: No predicate, its own new ideaIDE and PMA required
◍ Social psychological.
Answer: Envionrment + individual + biology
◍ Criminal profiling helps law enforcement determine.
Answer: the type of person they should be looking for
◍ Main requirements for CLIA certified laboratory.
Answer: MUST have:Quality assurance programPersonnel
QualificationsQuality ControlLaboratory proceduresProficiency
testingLaboratory safety
◍ LDT WITHOUT analyte specific reagent.
Answer: Based on modification of a predicate instrumental analysis
◍ Reciprocity.
Answer: feel obligated to return favors
◍ Epidemiology.
Answer: the study of the distribution and determinants of states and events
in specified populations
◍ Significance of SOPs.
Answer: Minimize deviations + variations in clinical laboratory tests
◍ what are the 5 subspecialties of forensic psychology.
Answer: Police and public safety (Psychology of Police)Legal
PsychologyPsychology of Crime Psychology of Victims Correctional
psychology
◍ authentic voluntary.
Answer: Confessor is delusional or mentally ill
◍ How is target value determined?.
Answer: Peer meanTrue valueGold standard method value
, ◍ Why is method evaluation necessary?.
Answer: Quality assuranceDecision making criteriaCertifying agencies
requirement
◍ Consensus View.
Answer: Society functions as an integrated structureBehaviors must be
legally forbiddenLaws change to fit within what society considers
acceptableor not
◍ Internality.
Answer: cause is within or external
◍ It consists of the _____ of the science andprofession of psychology in four
primary domainsof practice.
Answer: application
◍ law relies on______ psychology relies on_______.
Answer: precedent and scientific method/ accumulation of data
◍ Law Functions by _____ & Psychology by ______.
Answer: Case method and Experimental method
◍ FDA.
Answer: Approves + regulates laboratory instruments, reagents, and blood
banks
◍ Purpose of proficiency testing.
Answer: Reflect how the lab is doing every day's patient tests in
pre-analytical, analytical, and post-analytical
◍ How are acceptable error limits determined?.
Answer: Normal reference rangeIntraindividual variationDifference between
normal and disease distribution
◍ When Is the development of an LDT appropriate?.
Answer: For a less demanded test, where a manufacturer would not make a
profit for investing the money and time to go through an FDA approval
QUESTIONS WITH CORRECT ANSWERS
GRADED A+
◍ All accreditation organizations that can certify the clinical lab.
Answer: AABBAOAASHICOLACAPTJC
◍ What are SOPs?.
Answer: Contained information required to perform a laboratory
testRequired by CLIA
◍ Systematic error.
Answer: BiasError in accuracy, but high precisionConsistently high or low.
Not both
◍ Consequences of unsuccessful PT performance.
Answer: Disqualification to perform the test
◍ What is target value of an external QC established by?.
Answer: Actual valueMean value within peer groupReference method result
value
◍ What needs to be in SOPs?.
Answer: SOP titleReagent informationPrincipleClinical utilityReference
RangeSpecimenInterferencesAnalytical range + reporting
limitProcedureQuality controlCalibrationReagent
preparation/handling/storageReferences
◍ Class II Medical Device.
Answer: Idea is based on pre-existing class III reagentRequires pre-market
data and post-market surveillance, patient registries, performance
standardsEx: A glucose assay has the same reaction as an existing class III
, reagent, but the reaction condition (such as temp or pH) is different
◍ Class III Medical Device.
Answer: No predicate, its own new ideaIDE and PMA required
◍ Social psychological.
Answer: Envionrment + individual + biology
◍ Criminal profiling helps law enforcement determine.
Answer: the type of person they should be looking for
◍ Main requirements for CLIA certified laboratory.
Answer: MUST have:Quality assurance programPersonnel
QualificationsQuality ControlLaboratory proceduresProficiency
testingLaboratory safety
◍ LDT WITHOUT analyte specific reagent.
Answer: Based on modification of a predicate instrumental analysis
◍ Reciprocity.
Answer: feel obligated to return favors
◍ Epidemiology.
Answer: the study of the distribution and determinants of states and events
in specified populations
◍ Significance of SOPs.
Answer: Minimize deviations + variations in clinical laboratory tests
◍ what are the 5 subspecialties of forensic psychology.
Answer: Police and public safety (Psychology of Police)Legal
PsychologyPsychology of Crime Psychology of Victims Correctional
psychology
◍ authentic voluntary.
Answer: Confessor is delusional or mentally ill
◍ How is target value determined?.
Answer: Peer meanTrue valueGold standard method value
, ◍ Why is method evaluation necessary?.
Answer: Quality assuranceDecision making criteriaCertifying agencies
requirement
◍ Consensus View.
Answer: Society functions as an integrated structureBehaviors must be
legally forbiddenLaws change to fit within what society considers
acceptableor not
◍ Internality.
Answer: cause is within or external
◍ It consists of the _____ of the science andprofession of psychology in four
primary domainsof practice.
Answer: application
◍ law relies on______ psychology relies on_______.
Answer: precedent and scientific method/ accumulation of data
◍ Law Functions by _____ & Psychology by ______.
Answer: Case method and Experimental method
◍ FDA.
Answer: Approves + regulates laboratory instruments, reagents, and blood
banks
◍ Purpose of proficiency testing.
Answer: Reflect how the lab is doing every day's patient tests in
pre-analytical, analytical, and post-analytical
◍ How are acceptable error limits determined?.
Answer: Normal reference rangeIntraindividual variationDifference between
normal and disease distribution
◍ When Is the development of an LDT appropriate?.
Answer: For a less demanded test, where a manufacturer would not make a
profit for investing the money and time to go through an FDA approval
