ASHRM CPHRM Exam Questions

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, the Safe Medical Devices Act SMDA establishes mandatory reporting requirements for certain healthcare facilities when a medical device has or may have caused or contributed to a patient death or serious injury. These requirements apply to device user facilities, which include hospitals, nursing homes, and ambulatory surgical facilities.

Hospitals are explicitly required to report device-related deaths to both the FDA and the manufacturer, and serious injuries to the manufacturer or the FDA if the manufacturer is unknown. Nursing homes and ambulatory surgery centers are also considered device user facilities under the Act and must comply with similar reporting obligations.

Physician offices, however, are generally not classified as device user facilities under SMDA reporting rules and therefore are not subject to the same mandatory reporting requirements, although voluntary reporting is encouraged.

Legal and regulatory objectives emphasize timely compliance with FDA reporting mandates, maintenance of documentation, and coordination with manufacturers and regulatory authorities to mitigate risk and enhance patient safety. Therefore, the SMDA reporting requirements apply to nursing homes, ambulatory surgery facilities, and hospitals.

Broad incident definitions (including near-misses and unsafe conditions) support proactive risk management. If reporting is limited only to severe harm, the organization loses learning opportunities from early warning signals. Risk management objectives favor capturing deviations from expected process---falls without injury, specimen labeling near-misses, medication dispensing discrepancies---because these events reveal system vulnerabilities that can later cause major harm. Strong incident management includes classification, timely review, escalation thresholds, root cause analysis for significant events, and feedback to frontline staff. This approach aligns with systems-based safety: identify hazards, implement controls, and monitor effectiveness.

Within Health Care Risk Management practice as outlined by ASHRM and the American Hospital Association Certification Center, understanding legal process documents is essential to effective claims management and litigation response. A subpoena duces tecum is a court-issued legal instrument requiring an individual or organization to produce specified documents, records, or tangible evidence relevant to a legal proceeding.

In many jurisdictions, a subpoena duces tecum may also require the recipient to appear at a deposition, hearing, or trial while producing the requested documents. The key distinguishing feature is the command to bring documents or evidence. Compliance is mandatory unless successfully challenged or quashed by the court.

Providing a list of all parties involved or disclosing expert witness identities are generally handled through formal discovery processes such as interrogatories, requests for production, or court-ordered disclosures, not specifically by a subpoena duces tecum.

Claims and litigation objectives emphasize prompt review of subpoenas, coordination with legal counsel, protection of privileged information, and timely compliance to avoid sanctions. Therefore, a subpoena duces tecum requires production of specified documents and may also compel appearance, making options 1 and 2 correct.

In Failure Modes and Effects Analysis (FMEA), the Risk Priority Number (RPN) is commonly calculated as the product of three ratings: Severity (S) of impact, Occurrence (O) likelihood/probability, and Detection (D) ability to detect the failure before it causes harm (lower detectability increases risk). This structured scoring helps teams prioritize which failure modes deserve immediate mitigation. Risk management objectives include proactively identifying high-risk process steps (medication administration, specimen labeling, surgery scheduling), designing controls (standard work, forcing functions, redundancy), and tracking residual risk after changes. While cost and feasibility may influence selection of mitigations, they are not the core RPN elements. Using S--O--D improves transparency in prioritization, supports interdisciplinary alignment, and provides a defensible rationale for resource allocation toward patient safety improvements.

According to Health Care Risk Management standards outlined by ASHRM and the American Hospital Association Certification Center, proactive workplace violence prevention focuses on measures implemented before an incident occurs. These strategies aim to identify risks, strengthen preparedness, and reduce the likelihood or severity of violent events.

Pre-employment background screening helps identify applicants with histories that may pose safety concerns, consistent with legal hiring standards. Ongoing staff training enhances awareness of warning signs, communication skills, and reporting procedures. Leadership rounding increases visibility, supports early identification of environmental or behavioral risks, and reinforces safety culture. Active shooter drills and emergency preparedness exercises ensure that staff understand response protocols and can act effectively under stress.

Options B, C, and D primarily describe reactive or post-incident measures. Law enforcement notification, restraining orders, crisis intervention, DEA notification, documentation, and emergency command activation occur after an event has taken place or when an immediate threat is present.

Health Care Operations objectives emphasize prevention, preparedness, environmental assessment, and workforce education as foundational elements of a workplace violence program. Therefore, pre-employment screening, training, rounding, and drills represent proactive components of an effective prevention strategy.