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

An observation only, with no corrective action required

Answer

A paperwork issue that can be resolved by recreating records retroactively

Answer

A minor finding, since 85% compliance is above the industry benchmark

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

Reduce the biomedical department's operating budget

Answer

Identify equipment to be sold as surplus

Answer

Determine which staff members should be promoted

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

Immediately discard all affected devices without notification

Answer

Wait for the manufacturer's representative to visit before taking any action

Answer

Notify the media about the safety concern

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

Providing a general statement that the department will 'do better'

Answer

Listing all devices that passed PM inspection in the same period

Answer

Requesting an extension without providing any planned actions

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

The vendors may charge higher rates than in-house staff

Answer

The department may have too many vendors to manage

Answer

Contract vendors may request time off during peak periods

Question 6

The 'safe harbor' provision that some healthcare organizations use to exempt certain low-risk devices from formal PM programs is governed by which accrediting body's standards?

Accepted Answer

The Joint Commission (TJC) Environment of Care standards

Answer

OSHA

Answer

The EPA

Answer

The Department of Labor