ABPath - American Board of Pathology Laboratory Management Questions and Answers

Question 1

A new molecular diagnostics section is being established, which will perform high-complexity testing.
According to CLIA '88 regulations, which of the following individuals meets the minimum qualifications to serve as the Technical Supervisor for this section?

Accepted Answer

An individual with a bachelor's degree in clinical laboratory science and 2 years of experience in high-complexity testing.

Answer

An individual with an associate's degree in medical laboratory technology and 4 years of experience in high-complexity testing.

Answer

A physician with a license to practice medicine and 1 year of experience overseeing a moderate complexity laboratory.

Answer

An individual with a master's degree in biology and 6 months of training in the specific high-complexity assays being performed.

Question 2

A chemistry analyzer's daily quality control for creatinine has a mean of 1.0 mg/dL and a standard deviation (SD) of 0.05 mg/dL. The results for the last two consecutive runs of the same control level were 1.11 mg/dL and 1.12 mg/dL. This pattern represents a violation of which Westgard rule?

Accepted Answer

2_2s

Answer

1_3s

Answer

R_4s

Answer

4_1s

Question 3

According to the Occupational Safety and Health Administration (OSHA) Laboratory Standard (29 CFR 1910.1450), which of the following is a required element of a laboratory's Chemical Hygiene Plan (CHP)?

Accepted Answer

Criteria the employer will use to determine and implement control measures, such as engineering controls and personal protective equipment.

Answer

The specific brand and vendor for all personal protective equipment used in the laboratory.

Answer

A list of all employees who have been exposed to hazardous chemicals in the past year.

Answer

The fee schedule for medical consultations and examinations for employees with potential overexposure.

Question 4

A clinical laboratory is implementing a new, unmodified, FDA-approved assay. According to CLIA '88, which of the following sets of performance characteristics must the laboratory verify before using the test for patient reporting?

Accepted Answer

Accuracy, precision, reportable range, and reference interval.

Answer

Analytical sensitivity, analytical specificity, and linearity.

Answer

Full method validation including interfering substance studies.

Answer

Only the manufacturer's stated reportable range and reference interval.

Question 5

A laboratory is considering purchasing a new instrument that has a fixed cost of $120,000. The variable cost per test (e.g., reagents, consumables) is $8, and the reimbursement per test is $20. Disregarding other fixed costs like labor and overhead, how many tests must be performed to reach the break-even point for the instrument?

Accepted Answer

10,000

Answer

6,000

Answer

15,000

Answer

5,000

Question 6

A laboratory fails a proficiency testing (PT) event for a CLIA-regulated analyte. This is the second consecutive PT event where the laboratory has demonstrated unsuccessful performance for this same analyte. According to CLIA regulations, what is the most significant and immediate required action?

Accepted Answer

The laboratory must immediately cease all patient testing for that specific analyte.

Answer

The laboratory director must attend remedial training.

Answer

The laboratory is placed on probation and subject to an on-site inspection.

Answer

The laboratory must pay a monetary fine and submit a corrective action plan.