CBA CBA Healthcare Facility Operations & Safety Standards 3

Question 1

During a mock survey preparation audit, the biomedical team cannot locate PM records for 15% of their active device inventory. The auditor should classify this as:

Accepted Answer

A major finding, as incomplete records indicate a systemic program failure

Answer

Missing PM records for 15% of active devices indicates a systemic record-keeping or program execution failure that constitutes a major nonconformance requiring root cause analysis.

Question 2

The primary goal of a healthcare technology management (HTM) audit is to:

Accepted Answer

Verify that the organization's medical equipment is safe, maintained, and managed in compliance with applicable standards

Answer

An HTM audit assesses whether the entire lifecycle of medical equipment—from acquisition through disposal—is managed safely and in compliance with regulatory and accreditation requirements.

Question 3

When a new FDA safety alert or recall is issued for a medical device, a biomedical department's FIRST step should be:

Accepted Answer

Identify all affected devices in inventory and assess the risk per the alert's instructions

Answer

Upon receipt of an FDA alert or recall notice, the biomedical team must first cross-reference their inventory to identify all affected devices and then follow the alert's specified risk mitigation steps.

Question 4

Which element is MOST important when writing a corrective action plan (CAP) in response to a biomedical audit finding?

Accepted Answer

Identifying the person responsible, root cause, specific actions, and target completion dates

Answer

An effective CAP must identify accountability, address the true root cause, describe specific corrective actions, and include measurable timelines for completion.

Question 5

A biomedical auditor notes that a hospital has no formal process for evaluating and onboarding contract biomedical service vendors. The MOST relevant concern is:

Accepted Answer

Unqualified vendors may perform unsafe repairs, creating patient risk and regulatory liability

Answer

Without a vendor qualification process, the hospital cannot ensure that outside service providers have the training, tools, and authorization needed to safely service medical equipment.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA CBA Healthcare Facility Operations & Safety Standards 3