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NEW QUESTION # 67
When conducting an investigation of a liability claim, which of the following steps should be included?
* providing the RCA to the insurance company
* determining the applicable standard of care
* assessing the applicable legal principles
* obtaining an incident report from the claimant
Answer: B
Explanation:
According to Health Care Risk Management standards established by ASHRM and the American Hospital Association Certification Center, investigation of a liability claim requires careful evaluation of both clinical and legal components. Determining the applicable standard of care is essential to assess whether the provider' s actions met accepted professional practice. This typically involves review of medical records, consultation with clinical experts, and comparison to established guidelines or customary practices within the specialty.
Assessing applicable legal principles is also critical. This includes analysis of duty, breach, causation, and damages, as well as jurisdiction-specific statutes of limitation, comparative negligence standards, and evidentiary considerations. Understanding the legal framework allows the risk manager to evaluate exposure and advise counsel appropriately.
Providing a root cause analysis to the insurance company may compromise privilege protections, depending on jurisdiction and policy structure. RCA documents are often protected under peer review or patient safety statutes and should not be disclosed without legal guidance. Obtaining an incident report from the claimant is not appropriate, as internal incident reports are generated by the organization and are not requested from claimants.
Claims and litigation objectives emphasize structured legal and clinical evaluation. Therefore, determining the standard of care and assessing applicable legal principles are required investigative steps.
NEW QUESTION # 68
Which of the following is a program of the Food and Drug Administration FDA post market surveillance system for medical devices that requires healthcare facilities to report patient deaths or injuries related to a medical device?
Answer: B
Explanation:
Under Health Care Risk Management standards recognized by ASHRM and the American Hospital Association Certification Center, the Safe Medical Devices Act SMDA is part of the FDA's post market surveillance system for medical devices. The SMDA requires healthcare facilities to report to the FDA and, in some cases, to the manufacturer when a medical device has or may have caused or contributed to a patient death or serious injury. This mandatory reporting system enhances device safety monitoring and supports regulatory oversight after products enter the market.
EMTALA governs emergency medical screening and stabilization obligations, not device reporting. The Occupational Safety and Health Act focuses on workplace safety for employees rather than patient device- related injuries. Patient Safety Organizations operate under the Patient Safety and Quality Improvement Act and facilitate voluntary reporting of patient safety events, but they do not replace FDA-mandated device reporting requirements.
Legal and regulatory objectives in healthcare risk management emphasize compliance with federal reporting statutes, timely submission of required reports, and maintenance of documentation to mitigate regulatory exposure. Therefore, the Safe Medical Devices Act is the correct answer regarding mandatory FDA post market surveillance reporting for device-related deaths or injuries.
NEW QUESTION # 69
If a practitioner requests a telemedicine consult with another practitioner in another state, the consultant:
Answer: C
Explanation:
Telemedicine licensure is largely state-based in the U.S., and many states require the consulting clinician to be licensed in the state where the patient is located (with exceptions such as specific compacts, special telehealth registrations, or emergency provisions). Risk management objectives include verifying licensure
/credentialing before services, ensuring privileging-by-proxy processes where applicable, confirming malpractice coverage for telehealth and cross-state practice, and ensuring informed consent/privacy safeguards. Failure to comply can trigger regulatory penalties, payer issues, and liability exposure if care is delivered without proper authorization.
NEW QUESTION # 70
If no specific OSHA standard applies to a given potential health hazard, then
Answer: D
Explanation:
According to Health Care Risk Management standards outlined by ASHRM and the American Hospital Association Certification Center, the Occupational Safety and Health Act includes a provision known as the General Duty Clause. This clause requires employers to furnish a workplace free from recognized hazards that are causing or are likely to cause death or serious physical harm, even when no specific OSHA standard addresses the hazard.
The General Duty Clause grants OSHA authority to cite employers for unsafe conditions not explicitly covered by a detailed regulation. To issue a citation under this clause, OSHA must demonstrate that a recognized hazard exists, that the hazard poses a risk of serious harm, and that feasible methods exist to correct or mitigate the hazard.
Therefore, OSHA retains enforcement authority even in the absence of a specific standard. The agency's jurisdiction does not disappear simply because no detailed regulation addresses the particular risk.
Legal and regulatory objectives in healthcare risk management emphasize maintaining compliance with federal occupational safety laws and proactively identifying workplace hazards. Accordingly, OSHA may govern the hazard under the General Duty Clause when no specific standard applies.
NEW QUESTION # 71
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: B
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 # 72
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