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NEW QUESTION # 96
The enterprise risk management process extends beyond clinical risk management by
Answer: B
NEW QUESTION # 97
If an at-risk patient is left unattended and has an adverse response to medication, this is best classified as:
Answer: B
Explanation:
Leaving an at-risk patient unattended during/after medication administration is typically anactive failure occurring at thesharp end-the point of direct care delivery. Active errors are the observable actions
/omissions by frontline personnel that can immediately contribute to harm (e.g., failure to monitor sedation, failure to reassess after opioids). Risk management objectives, however, require looking beyond the individual act: Was staffing insufficient? Was monitoring policy unclear? Were alarms ineffective? Was there inadequate training or workload overload? Those "blunt end" conditions create latent risk that increases the likelihood of sharp-end failures. Proper classification helps organizations respond with systems fixes (monitoring standards, escalation triggers, staffing acuity tools, continuous pulse oximetry/capnography policies where appropriate) rather than blaming individuals alone.
NEW QUESTION # 98
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: A
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 # 99
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: A
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 # 100
A hospital's Ethics Committee is seeking advice on a case involving the elective sterilization of an adolescent patient who is developmentally disabled. One of the parents is refusing consent. The risk manager should evaluate which of the following?
* who has consent authority
* competency level of the patient
* diagnosis of the patient
* state statutes and laws
Answer: B
Explanation:
Under Health Care Risk Management principles outlined by ASHRM and the American Hospital Association Certification Center, cases involving sterilization of minors, particularly those who are developmentally disabled, raise significant legal and regulatory concerns. The risk manager's primary responsibility is to ensure compliance with applicable consent laws and protect patient rights while minimizing organizational liability.
First, determining who has legal consent authority is essential. When parents disagree, state law typically governs whether both parents must consent, whether one parent's consent is sufficient, or whether court involvement is required. Second, evaluating the competency level of the patient is critical because decision- making capacity influences whether the patient can participate in consent or assent processes. Capacity assessments may require clinical and legal evaluation.
Third, state statutes and laws are highly relevant, as many jurisdictions impose strict legal requirements or court approval for sterilization of minors or individuals with developmental disabilities. These laws are designed to protect vulnerable populations.
The patient's diagnosis alone is not the determining legal factor; rather, decision-making capacity and statutory requirements are central. Therefore, the risk manager must evaluate consent authority, competency, and applicable state laws to ensure regulatory compliance and ethical integrity.
NEW QUESTION # 101
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