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

CLIA '88 specifies several pathways to qualify as a Technical Supervisor for high-complexity testing. One of the most common pathways requires an individual to have earned a bachelor's degree in a relevant science (such as clinical laboratory science or medical technology) and have at least 2 years of pertinent laboratory experience in high-complexity testing. The other options are incorrect because they lack the required degree level, sufficient duration of experience, or experience specifically in high-complexity testing.

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

The 2_2s Westgard rule is violated when two consecutive quality control points for the same level fall outside the same +2 SD or -2 SD limit. In this scenario, the +2 SD limit is 1.10 mg/dL (1.0 + 2*0.05). Both QC results (1.11 and 1.12 mg/dL) exceed this limit, indicating a systematic error that requires investigation.

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 OSHA Laboratory Standard (29 CFR 1910.1450) mandates that a laboratory's written Chemical Hygiene Plan (CHP) must include specific elements. A key required component is the establishment of criteria that the employer will use to determine and implement control measures to reduce employee exposure, including engineering controls, administrative controls, and personal protective equipment.

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

For an unmodified, FDA-approved test, CLIA '88 requires the laboratory to *verify* the manufacturer's stated performance specifications. This verification process must include demonstrating performance for accuracy, precision, reportable range, and verifying that the manufacturer's reference interval is appropriate for the laboratory's patient population. A full, more extensive validation is required only for laboratory-developed tests or modified FDA-approved tests.

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

The break-even point in units is calculated by dividing the total fixed costs by the contribution margin per unit. First, calculate the contribution margin: Reimbursement ($20) - Variable Cost ($8) = $12 per test. Then, divide the fixed cost by the contribution margin: $120,000 / $12 = 10,000 tests.

American Board of Pathology (ABPath) Practice Test

American Board of Pathology (ABPath) Practice Test

ABPath - American Board of Pathology Laboratory Management Questions and Answers