ASHRM Updated CPHRM Exam Questions and Answers by paris

Core risk treatment strategies includeavoidance(stop the activity),reduction/mitigation(controls that reduce likelihood/severity),retention(accept risk within appetite and fund losses via reserves/self-insurance), andtransfer(contracts/insurance shifting financial consequences). In healthcare, the highest priority is often mitigation for patient safety risks (standardization, technology, training), with financing mechanisms ensuring the organization can absorb residual loss without destabilizing operations. ERM aligns these strategies to enterprise objectives so leadership invests in the best mix of prevention and financing.

OSHA can cite employers under theGeneral Duty Clausewhen a recognized serious hazard exists and no specific standard applies. Risk management objectives require proactive hazard identification and controls even when regulations are not prescriptive: risk assessments, engineering controls where feasible, administrative controls (policies, training), and PPE as a final layer. In healthcare, this is relevant for emerging hazards (novel chemical exposures, workplace violence risks, certain ergonomic hazards) where specific standards may be limited. Maintaining documentation of hazard recognition and mitigation is essential for defensibility during inspections and for staff safety outcomes.

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.

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, coverage determination depends on both the policy trigger and relevant dates. The alleged negligence occurred on September 5, 2003. Under an occurrence policy in effect from 1/1/03 to 1/1/04, coverage applies because the event occurred during that policy period, regardless of when the claim was filed. Therefore, option 2 applies.

For a claims-made policy covering 1/1/03 to 1/1/04, coverage would require that the claim be made and reported during the policy period unless tail coverage is in place. Because the claim was received on July 3, 2004, after expiration of the 1/1/03 to 1/1/04 claims-made policy, coverage would apply only if a 1-year tail was purchased. Thus, option 3 applies.

Option 1 would not apply because the claim was made after the claims-made policy period ended, and no tail is specified. Option 4 would not apply because occurrence coverage from 1/1/04 to 1/1/05 would not cover an event that occurred in 2003.

Risk financing objectives emphasize understanding policy triggers, reporting requirements, and tail coverage. Therefore, the applicable coverage scenarios are the occurrence policy for 2003 and the claims-made policy with tail coverage.