Complete Question and Answer Bank – 75
Verified Questions with Rationale.
PURPOSE:
This comprehensive Q&A bank prepares clinical laboratory professionals for the
California State Licensing Test component of the CCLE (California Clinical Laboratory
License Examination). Content aligns with California Business and Professions Code
(BPC), California Code of Regulations (CCR) Title 17, and state-specific laboratory
licensing requirements effective 2025-2026.
EXAM FORMAT:
Total Questions: 75 multiple-choice
Each question has 4 options (A, B, C, D) with one correct answer
Detailed rationale provided for each correct answer (affirmative learning only)
Focuses on California-specific laws and regulations (not just federal CLIA)
EXAM Q&A BEGINS BELOW
QUESTION 1:
Under California Business and Professions Code, what is the minimum education
requirement to qualify for a Clinical Laboratory Scientist (CLS) license under CCR
Title 17 Section 1030.7 (effective January 1, 2025)?
A) Associate degree in medical laboratory technology
B) Bachelor's degree with 16 semester hours chemistry, 16 semester hours biology,
and 3 semester hours physics/math/statistics
C) High school diploma with 5 years of lab experience
D) Master's degree in clinical laboratory science
CORRECT ANSWER: B
RATIONALE: CCR Title 17 §1030.7 requires a bachelor's degree with specific science
coursework: 16 semester hours of chemistry (including quantitative analysis or
analytical chemistry AND clinical chemistry or biochemistry), 16 semester hours of
,biological science (including medical/clinical/pathogenic microbiology, hematology,
and immunology), and 3 semester hours of physics, mathematics, or statistics. This is
more stringent than CLIA, which allows associate degree personnel for high-
complexity testing. The updated requirements became effective January 1, 2025.
QUESTION 2:
A laboratory is hiring a director for a high-complexity molecular biology laboratory
in California. Which qualification meets California requirements under CCR Title 17
Section 1030.26?
A) MD with current California license and 2 years of genetics training
B) PhD in biology with no board certification
C) CLS with 5 years of bench experience and no graduate degree
D) Anyone who meets CLIA director qualifications (California automatically accepts)
CORRECT ANSWER: A
RATIONALE: CCR Title 17 §1030.26 requires laboratory directors of high-complexity
molecular biology labs to be either: (1) a physician and surgeon licensed in
California with 2 years of training in clinical genetic molecular biology in an
approved program, 2 years' experience, and board certification; or (2) a PhD with 30
semester hours of post-baccalaureate genetics coursework, 2 years of approved
training, 2 years of experience, and board certification. California does NOT
automatically accept CLIA director qualifications, which are less stringent.
QUESTION 3:
A CLS trainee license in California is valid for what maximum period under CCR Title
17 Section 1030.5?
A) 1 year, non-renewable
B) 2 years, renewable once for a total of 4 years
C) 3 years, renewable indefinitely
D) 5 years, non-renewable
CORRECT ANSWER: B
RATIONALE: CCR Title 17 §1030.5 specifies that CLS trainee licenses are valid for 2
years and may be renewed once for an additional 2 years (total maximum 4 years).
The trainee must be enrolled in a California-approved CLS training program and
work under direct and responsible supervision of a licensed physician, clinical
,laboratory bioanalyst, master's/doctoral specialist, CLS, or limited CLS. Failure to
complete training within 4 years requires retraining.
QUESTION 4:
According to California Business and Professions Code Section 1300, who can
perform clinical laboratory tests in a licensed California laboratory?
A) Anyone supervised by a CLS
B) Only individuals holding a valid California clinical laboratory license or trainee
license
C) Any graduate of an accredited MLT program regardless of license status
D) Anyone with a bachelor's degree in any science field
CORRECT ANSWER: B
RATIONALE: BPC §1300 prohibits unlicensed persons from performing clinical
laboratory tests in California. Only individuals holding a valid California clinical
laboratory license (CLS, MLT, limited license, or specialist license) or a CLS/MLT
trainee license may perform testing. This is stricter than many states that allow
unlicensed personnel under CLS supervision. California does not recognize academic
degrees or out-of-state training alone as authorization to practice.
QUESTION 5:
A CLS licensed in another state wants to work in California. What is required for
California licensure?
A) Automatic reciprocity because CLS is a national credential
B) Submit an application and pay fees; no additional requirements
C) Meet California's education requirements and pass the California CLS exam (or
equivalent approved certification)
D) Work under supervision for 2 years in California before independent licensure
CORRECT ANSWER: C
RATIONALE: California does NOT have full reciprocity with other states. Out-of-state
CLS applicants must meet California's specific education requirements (including the
updated science coursework under CCR §1030.7 effective January 1, 2025) and either
pass the California CLS exam or hold an approved national certification (ASCP, AAB,
AMT) AND complete a California-approved training program or equivalent
, experience approved by LFS. The California quiz on state laboratory laws is also
required.
QUESTION 6:
Under California Code of Regulations Title 17, how often must quality control (QC) be
run for most moderate complexity chemistry tests?
A) Once per week of patient testing
B) Once per day of patient testing
C) Once per 8-hour shift of patient testing
D) Each time a patient specimen is tested
CORRECT ANSWER: B
RATIONALE: CCR Title 17 requires QC to be run at least once each day of patient
testing for most moderate and high complexity tests. CLIA generally requires once
every 24 hours. California's requirement emphasizes daily testing regardless of
whether a full 24-hour period has elapsed. This ensures consistent quality
monitoring for all patient testing days.
QUESTION 7:
A California Medical Laboratory Technician (MLT) license allows the holder to
perform which of the following under CCR Title 17 Section 1030.6?
A) All clinical laboratory tests independently (full scope)
B) Moderate complexity testing under CLS supervision
C) High complexity testing without supervision
D) Any test waived by CLIA only
CORRECT ANSWER: B
RATIONALE: CCR Title 17 §1030.6 authorizes MLT license holders to perform
moderate complexity testing under the supervision of a CLS or other qualified
supervisor. MLTs cannot perform high complexity testing independently (CLS
required). The MLT scope is more restricted in California than in some other states.
Supervision requirements are specified in BPC §1260 and CCR §1030.6.
QUESTION 8:
A laboratory violates California laboratory regulations. What is the maximum civil
penalty per violation under the Business and Professions Code?