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CLIA-FOCUSED PHLEBOTOMY
CERTIFICATION EXAM 2026 QUESTIONS
LATEST VERSION QUESTIONS AND ANSWERS
CLIA-Focused Phlebotomy Certification Exam: 250 Practice Questions with Rationales
Key CLIA Concepts for Phlebotomy
Based on CLIA (Clinical Laboratory Improvement Amendments) regulations:
CLIA Established 1988: Levels of laboratory testing complexity were established by CLIA
to ensure quality laboratory testing results regardless of where testing is performed .
Test Complexity Categories: CLIA classifies tests into waived, moderate complexity, and
high complexity. Phlebotomists can perform waived tests and, with proper training and
certification, moderate complexity tests as defined by CLIA Section 493.1421 .
Certificate of Waiver: Required for facilities performing only waived tests. Adding
moderate complexity testing to a Certificate of Waiver facility exceeds the scope and requires
a Certificate of Compliance .
Quality Control: Controls are materials with known values that help laboratories achieve
accurate testing by checking if the test system is working properly .
Documentation Requirements: Patient test results must be recorded with test name, date,
time of test, and initials of testing personnel. Do not record on unidentified post-it notes or
scrap paper .
DOMAIN 1: CLIA REGULATIONS AND COMPLEXITY (50 Questions)
1. Levels of laboratory testing complexity were established by which regulatory body?
A) CAP (College of American Pathologists)
B) CLIA (Clinical Laboratory Improvement Amendments)
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C) CLSI (Clinical and Laboratory Standards Institute)
D) COLA (Commission on Office Laboratory Accreditation)
Answer: B) CLIA (Clinical Laboratory Improvement Amendments)
Rationale: The Clinical Laboratory Improvement Amendments of 1988 established the levels
of laboratory testing complexity. CLIA was enacted to ensure quality laboratory testing by
regulating all laboratory testing performed on humans in the United States .
2. The objective of the CLIA program is to ensure which of the following?
A) Laboratories are profitable and efficient
B) Quality laboratory testing is performed regardless of where testing is done
C) All laboratory personnel are licensed physicians
D) Laboratories only perform high complexity testing
Answer: B) Quality laboratory testing is performed regardless of where testing is done
Rationale: The primary objective of the CLIA program is to ensure quality laboratory testing.
CLIA applies to all laboratory testing performed on humans in the United States, regardless
of the testing site .
3. A phlebotomist is performing point-of-care testing. According to CLIA regulations,
which of the following tests is within the defined scope of practice for a phlebotomist?
A) Cell differential and urine sediment
B) Strep test and urine sediment
C) Urine dip and cell differential
D) Strep test and urine dip
Answer: D) Strep test and urine dip
Rationale: CLIA-waived tests such as rapid strep tests and urine dipstick tests are within the
scope of practice for phlebotomists. Cell differential and urine sediment microscopy are
moderate or high complexity tests that require additional training and certification .
4. Which of the following is considered a CLIA-waived test?
A) Complete blood count with differential
B) Urinalysis with microscopic examination
C) Rapid strep test
D) Blood culture and sensitivity
Answer: C) Rapid strep test
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Rationale: Rapid strep tests are CLIA-waived tests that can be performed by phlebotomists
and other trained healthcare personnel. CBC with differential, microscopic urinalysis, and
blood cultures are moderate or high complexity tests .
5. Laboratory test kits designed for home use fall within which classification of
laboratory tests under CLIA?
A) Moderate complexity
B) High complexity
C) Waived
D) Provider-performed microscopy
Answer: C) Waived
Rationale: Laboratory test kits designed for home use are classified as CLIA-waived tests.
These tests are considered simple and have a low risk of erroneous results. They include
pregnancy tests, glucose monitors, and COVID-19 home tests .
6. A physician's office performs only CLIA-waived tests. What type of CLIA certificate
does this facility need?
A) Certificate of Compliance
B) Certificate of Accreditation
C) Certificate of Waiver
D) Certificate of Registration
Answer: C) Certificate of Waiver
Rationale: A Certificate of Waiver is required for facilities that perform only CLIA-waived
tests. This is the most common certificate for small clinics and physician offices. Adding
moderate complexity testing would require a Certificate of Compliance .
7. According to CLIA regulations, which of the following actions is outside the scope of
practice for a phlebotomist?
A) Verifying equipment function on point-of-care testing using a control
B) Prioritizing collections based on order requests
C) Recording quality control results on a log sheet
D) Performing CLIA moderate complexity tests
Answer: D) Performing CLIA moderate complexity tests
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Rationale: Performing moderate complexity tests is generally outside the phlebotomist's
scope of practice unless the phlebotomist has specific additional training and the facility has
proper certification. Phlebotomists can perform waived tests and, with training, some
moderate complexity tests under CLIA Section 493.1421 .
8. A phlebotomist is using a point-of-care testing system. According to CLIA
requirements for waived testing, which task should be completed prior to daily use of
the instrument?
A) Run a patient test sample first
B) Perform quality control on the instrument
C) Ensure that quality control was performed within the last month
D) Perform quality control and calibrate the instrument
Answer: B) Perform quality control on the instrument
Rationale: Quality control should be performed before daily use of a point-of-care instrument
to ensure the test system is working properly. Calibration is typically outside the
phlebotomist's scope of practice .
9. A laboratory performing moderate complexity testing must meet requirements for
which of the following under CLIA?
A) No quality control required
B) Quality control, proficiency testing, and personnel qualifications
C) Only personnel qualifications
D) Only proficiency testing
Answer: B) Quality control, proficiency testing, and personnel qualifications
Rationale: Facilities performing moderate complexity testing must meet CLIA requirements
including quality control procedures, participation in proficiency testing, and specific
personnel qualifications. These requirements are more stringent than those for waived
testing .
10. Under CLIA, a phlebotomy technician can perform moderate complexity testing if
they meet which of the following requirements?
A) They have a high school diploma only
B) They have specific training and competency documentation as defined by CLIA
CLIA-FOCUSED PHLEBOTOMY
CERTIFICATION EXAM 2026 QUESTIONS
LATEST VERSION QUESTIONS AND ANSWERS
CLIA-Focused Phlebotomy Certification Exam: 250 Practice Questions with Rationales
Key CLIA Concepts for Phlebotomy
Based on CLIA (Clinical Laboratory Improvement Amendments) regulations:
CLIA Established 1988: Levels of laboratory testing complexity were established by CLIA
to ensure quality laboratory testing results regardless of where testing is performed .
Test Complexity Categories: CLIA classifies tests into waived, moderate complexity, and
high complexity. Phlebotomists can perform waived tests and, with proper training and
certification, moderate complexity tests as defined by CLIA Section 493.1421 .
Certificate of Waiver: Required for facilities performing only waived tests. Adding
moderate complexity testing to a Certificate of Waiver facility exceeds the scope and requires
a Certificate of Compliance .
Quality Control: Controls are materials with known values that help laboratories achieve
accurate testing by checking if the test system is working properly .
Documentation Requirements: Patient test results must be recorded with test name, date,
time of test, and initials of testing personnel. Do not record on unidentified post-it notes or
scrap paper .
DOMAIN 1: CLIA REGULATIONS AND COMPLEXITY (50 Questions)
1. Levels of laboratory testing complexity were established by which regulatory body?
A) CAP (College of American Pathologists)
B) CLIA (Clinical Laboratory Improvement Amendments)
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C) CLSI (Clinical and Laboratory Standards Institute)
D) COLA (Commission on Office Laboratory Accreditation)
Answer: B) CLIA (Clinical Laboratory Improvement Amendments)
Rationale: The Clinical Laboratory Improvement Amendments of 1988 established the levels
of laboratory testing complexity. CLIA was enacted to ensure quality laboratory testing by
regulating all laboratory testing performed on humans in the United States .
2. The objective of the CLIA program is to ensure which of the following?
A) Laboratories are profitable and efficient
B) Quality laboratory testing is performed regardless of where testing is done
C) All laboratory personnel are licensed physicians
D) Laboratories only perform high complexity testing
Answer: B) Quality laboratory testing is performed regardless of where testing is done
Rationale: The primary objective of the CLIA program is to ensure quality laboratory testing.
CLIA applies to all laboratory testing performed on humans in the United States, regardless
of the testing site .
3. A phlebotomist is performing point-of-care testing. According to CLIA regulations,
which of the following tests is within the defined scope of practice for a phlebotomist?
A) Cell differential and urine sediment
B) Strep test and urine sediment
C) Urine dip and cell differential
D) Strep test and urine dip
Answer: D) Strep test and urine dip
Rationale: CLIA-waived tests such as rapid strep tests and urine dipstick tests are within the
scope of practice for phlebotomists. Cell differential and urine sediment microscopy are
moderate or high complexity tests that require additional training and certification .
4. Which of the following is considered a CLIA-waived test?
A) Complete blood count with differential
B) Urinalysis with microscopic examination
C) Rapid strep test
D) Blood culture and sensitivity
Answer: C) Rapid strep test
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Rationale: Rapid strep tests are CLIA-waived tests that can be performed by phlebotomists
and other trained healthcare personnel. CBC with differential, microscopic urinalysis, and
blood cultures are moderate or high complexity tests .
5. Laboratory test kits designed for home use fall within which classification of
laboratory tests under CLIA?
A) Moderate complexity
B) High complexity
C) Waived
D) Provider-performed microscopy
Answer: C) Waived
Rationale: Laboratory test kits designed for home use are classified as CLIA-waived tests.
These tests are considered simple and have a low risk of erroneous results. They include
pregnancy tests, glucose monitors, and COVID-19 home tests .
6. A physician's office performs only CLIA-waived tests. What type of CLIA certificate
does this facility need?
A) Certificate of Compliance
B) Certificate of Accreditation
C) Certificate of Waiver
D) Certificate of Registration
Answer: C) Certificate of Waiver
Rationale: A Certificate of Waiver is required for facilities that perform only CLIA-waived
tests. This is the most common certificate for small clinics and physician offices. Adding
moderate complexity testing would require a Certificate of Compliance .
7. According to CLIA regulations, which of the following actions is outside the scope of
practice for a phlebotomist?
A) Verifying equipment function on point-of-care testing using a control
B) Prioritizing collections based on order requests
C) Recording quality control results on a log sheet
D) Performing CLIA moderate complexity tests
Answer: D) Performing CLIA moderate complexity tests
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Rationale: Performing moderate complexity tests is generally outside the phlebotomist's
scope of practice unless the phlebotomist has specific additional training and the facility has
proper certification. Phlebotomists can perform waived tests and, with training, some
moderate complexity tests under CLIA Section 493.1421 .
8. A phlebotomist is using a point-of-care testing system. According to CLIA
requirements for waived testing, which task should be completed prior to daily use of
the instrument?
A) Run a patient test sample first
B) Perform quality control on the instrument
C) Ensure that quality control was performed within the last month
D) Perform quality control and calibrate the instrument
Answer: B) Perform quality control on the instrument
Rationale: Quality control should be performed before daily use of a point-of-care instrument
to ensure the test system is working properly. Calibration is typically outside the
phlebotomist's scope of practice .
9. A laboratory performing moderate complexity testing must meet requirements for
which of the following under CLIA?
A) No quality control required
B) Quality control, proficiency testing, and personnel qualifications
C) Only personnel qualifications
D) Only proficiency testing
Answer: B) Quality control, proficiency testing, and personnel qualifications
Rationale: Facilities performing moderate complexity testing must meet CLIA requirements
including quality control procedures, participation in proficiency testing, and specific
personnel qualifications. These requirements are more stringent than those for waived
testing .
10. Under CLIA, a phlebotomy technician can perform moderate complexity testing if
they meet which of the following requirements?
A) They have a high school diploma only
B) They have specific training and competency documentation as defined by CLIA
