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NEW QUESTION # 45
An organization's chief of orthopedics has scheduled an implant of a new artificial hip for the next day. The chief developed the artificial hip while working as a consultant for a medical device company. The device has not yet been approved by the FDA or the Institutional Review Board. The risk manager's best immediate course of action is to
Answer: C
Explanation:
Under Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, the implantation of a medical device that lacks FDA approval and Institutional Review Board oversight presents significant legal and regulatory violations. Use of an unapproved device outside of an approved investigational protocol may violate federal regulations governing human subject research and medical device approval processes.
The risk manager's primary responsibility is to immediately mitigate regulatory and liability exposure.
Because the procedure is scheduled for the next day, urgent intervention is required. Contacting the FDA would not resolve the immediate risk. Verifying informed consent is insufficient, as patient consent cannot legitimize use of an unapproved device outside regulatory pathways. Calling a special IRB meeting would not retroactively authorize an unapproved device without appropriate investigational device exemption processes.
Escalating the issue to the chief of surgery to halt or cancel the procedure is the most appropriate immediate step. This ensures that organizational leadership addresses the compliance violation before patient harm occurs. Risk management objectives emphasize proactive prevention of regulatory breaches, protection of patient safety, and preservation of institutional integrity. Therefore, stopping the procedure is the correct and immediate action.
NEW QUESTION # 46
According to The Joint Commission, which of the following should be done to patient-owned electrical devices entering the facility?
Answer: A
Explanation:
According to Health Care Risk Management standards supported by ASHRM and accreditation guidance from The Joint Commission, patient-owned electrical devices brought into healthcare facilities must be evaluated to ensure they do not pose safety risks. The Joint Commission's Environment of Care standards emphasize electrical safety, fire prevention, and reduction of hazards within patient care areas.
Before a patient-owned electrical device is used within the facility, an electrical safety inspection should be conducted to assess the integrity of cords, plugs, grounding, and overall condition. The purpose is to identify potential risks such as frayed wiring, overheating hazards, or improper voltage compatibility that could endanger patients, staff, or equipment.
Simply inventorying the device with personal belongings does not address safety concerns. Sequestering the device may be appropriate if it fails inspection, but routine confiscation is not required. While biomedical engineering departments often assist with inspections, tagging by biomedical engineering is not itself the required action; the essential requirement is that a safety inspection be performed.
Clinical and patient safety objectives emphasize proactive hazard identification and compliance with accreditation standards. Therefore, conducting an electrical safety inspection is the appropriate action for patient-owned electrical devices entering the facility.
NEW QUESTION # 47
Which of the following isnotone of the patient rights enumerated in the Patient Self-Determination Act (PSDA)?
Answer: C
Explanation:
The PSDA focuses onpatient autonomy and informed decision-making, especially aroundadvance directives. It requires certain healthcare organizations to inform patients of their rights under state law to make decisions about medical care, ask whether the patient has an advance directive, document it, and avoid discrimination based on whether an advance directive exists. The Act doesnotcreate a right for patients to select any medication they want irrespective of clinical appropriateness, prescribing laws, formularies, allergies, contraindications, or standards of care. Risk management objectives here include: ensuring compliant admission workflows (education + documentation), reducing disputes through early clarification of preferences, and preventing ethical/legal breakdowns during incapacity. Operationally, PSDA compliance improves care planning, reduces unwanted treatment, and lowers complaint/litigation risk by showing the organization respected patient rights and followed required processes.
NEW QUESTION # 48
A hospital uses the same labels for all prescriptions, but they don't fit on small containers, so employees must cut/paste labels in a special way. This is an example of:
Answer: A
Explanation:
In Lean terms,extra processingis work that does not add value from the patient's perspective and often introduces defect risk. Cutting and reformatting labels is a classic extra-processing waste: it consumes time, creates variability, and increases the likelihood of mislabeling-one of the most serious medication safety hazards. Risk management objectives prioritize eliminating rework and standardizing the labeling process through right-sized labels, standardized print templates by container type, barcode integration, and human factors design (font size, tall-man lettering where appropriate). Removing extra processing improves efficiency and reduces cognitive load and workaround culture-both strongly associated with error.
Operationally, this is a system design failure: staff are compensating for poor equipment/process fit. Fixing the system reduces the chance of a high-severity adverse event and strengthens defensibility by demonstrating proactive hazard elimination.
NEW QUESTION # 49
A patient who has suffered a stroke is aphasic and unable to swallow. The physician would like to place a PEG tube for feeding. The patient is considered incapacitated and his wife consents to the treatment. The patient's adult children do not. The wife and oldest daughter each present a power of attorney document identifying them as the designated decision makers. To support the ethical principle of patient autonomy, which of the following should the risk manager recommend?
Answer: A
Explanation:
Under Health Care Risk Management principles supported by ASHRM and the American Hospital Association Certification Center, patient autonomy is upheld by honoring valid advance directives and durable powers of attorney for healthcare. When multiple documents are presented that designate different decision makers, the most recent properly executed document typically supersedes earlier versions, unless state law provides otherwise.
Durable powers of attorney for healthcare may be revoked or replaced by executing a newer document.
Therefore, determining the effective document requires reviewing execution dates and ensuring validity under applicable state statutes, including witnessing and notarization requirements. The document with the more recent date generally reflects the patient's latest expressed wishes and controls decision-making authority.
Referring immediately to an ethics committee may be appropriate in unresolved value conflicts, but first establishing legal authority is essential. Asking the family to resolve the dispute independently delays necessary medical decisions and does not clarify legal standing. Selecting the older document would contradict the principle that later directives replace earlier ones.
Legal and regulatory objectives emphasize verification of surrogate authority, compliance with state advance directive laws, and protection of patient autonomy. Therefore, the risk manager should confirm which document is most recent and legally valid.
NEW QUESTION # 50
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