Practice Free CPHRM Certified Professional in Health Care Risk Management (CPHRM) Exam Questions Answers With Explanation

According to Health Care Risk Management standards outlined by ASHRM and the American Hospital Association Certification Center, the risk management department should establish formal policies addressing core operational responsibilities. Coordination of responses to subpoenas is a critical function involving legal compliance, protection of privileged information, and collaboration with counsel. Departmental accountability for occurrence reporting is essential to ensure proper event identification, investigation, and trending. Additionally, defining the risk management reporting process to the governing body supports board oversight and enterprise risk management responsibilities.

Responses to freedom of information requests, however, are generally governed by legal, compliance, or public information offices, particularly in public institutions subject to open records laws. While risk management may provide input if records involve claims or adverse events, primary responsibility for handling such requests typically resides outside the risk management department.

Health Care Operations objectives emphasize clearly defined departmental scope, structured reporting relationships, and alignment with governance responsibilities. Therefore, while subpoena coordination, occurrence reporting, and board reporting are appropriate policy areas for risk management, responses to freedom of information requests fall outside its primary policy development scope.

The HIPDB was established to help combathealthcare fraud and abuse, while the NPDB historically focused on practitioner competence and professional conduct (including items like malpractice payments and certain adverse actions). HRSA explains that HIPDB is no longer separate and that its information is now collected and disclosed through the NPDB following the 2013 merger. For risk managers, the objective is to ensure credentialing, contracting, and compliance teams understand the expanded scope and proper use: querying supports safer hiring/privileging decisions and reduces negligent credentialing risk, while reporting supports system integrity. Organizations must also ensure due process and correct categorization of reportable events to avoid wrongful reporting exposure.

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, occurrence coverage provides protection for incidents that occur during the policy period, regardless of when the claim is reported. The triggering event is the date of the occurrence. As long as the alleged act or omission took place while the policy was in force, coverage applies even if the claim is filed years later.

Option A is incorrect because occurrence coverage does not extend to incidents that occur prior to the policy’s effective date. Coverage is strictly tied to the policy period.

Option C is incorrect because in claims-made coverage, the retroactive date is critical. Coverage applies only to claims made during the policy period for incidents that occurred on or after the retroactive date.

Option D is incorrect because the “nose” period, also known as prior acts coverage, is highly significant in claims-made policies. It determines whether earlier acts are covered when switching carriers.

Risk financing objectives emphasize understanding policy triggers, retroactive dates, and reporting requirements. Therefore, occurrence coverage applies to incidents that occur while the policy is in effect.

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 frameworks identified by ASHRM and the American Hospital Association Certification Center, organizational culture refers to the collective values, shared norms, guiding beliefs, and behavioral expectations that shape how members of a healthcare organization function. It influences decision-making, communication patterns, leadership styles, and responses to risk and safety concerns. Culture is transmitted formally through policies and training, and informally through leadership behavior, peer interactions, and organizational traditions.

Organizational culture plays a critical role in patient safety, compliance, and ethical conduct. A strong culture of safety encourages reporting of adverse events, supports transparency, and promotes continuous improvement. Conversely, a punitive or hierarchical culture may suppress reporting and increase liability exposure.

Corporate vision describes the aspirational future state of the organization. A strategic mission outlines the organization’s purpose and objectives. Managerial ethics refers to principles guiding leadership conduct. While these elements contribute to the broader organizational framework, they do not encompass the shared and socially transmitted system of norms and beliefs that define culture.

Therefore, the correct term describing shared and taught values and norms within a healthcare organization is organizational culture.

According to Health Care Risk Management standards outlined by ASHRM and the American Hospital Association Certification Center, the governing board has ultimate responsibility for organizational oversight, quality of care, and patient safety. As part of its fiduciary and governance duties, the board approves high-level policies that establish the organization’s philosophy, strategic direction, and commitment to safety and risk management.

A philosophy regarding medical error management reflects the organization’s approach to disclosure, reporting, just culture principles, accountability, and system improvement. Because this philosophy sets the tone for organizational culture and impacts patient safety, legal exposure, and regulatory compliance, it requires board-level approval to ensure alignment with governance expectations and accreditation standards.

In contrast, the risk management department’s annual budget is typically approved through financial governance processes rather than as a policy document. Risk analyses are operational tools conducted by management and do not require board approval. Departmental personnel job descriptions are administrative documents managed at the executive or human resources level.

Health Care Operations objectives emphasize board engagement in safety culture and oversight of enterprise risk management. Therefore, the philosophy regarding medical error management should be approved by the organization’s board of directors.

According to Health Care Risk Management principles supported by ASHRM and the American Hospital Association Certification Center, total incurred amounts include both paid amounts and reserves. Incurred expense equals expense paid plus expense reserves. Incurred indemnity equals indemnity paid plus indemnity reserves.

For Year 4:

Total incurred expense = $25,000 reserves + $15,000 paid = $40,000.

Total incurred indemnity = $150,000 reserves + $75,000 paid = $225,000.

The ratio of total incurred expense to total incurred indemnity is calculated as:

$40,000 ÷ $225,000 = 0.1778, which rounds to approximately 0.18.

However, among the answer options provided, the closest value is 0.20 only if rounded broadly. Since precise calculation yields approximately 0.18, the mathematically correct ratio is approximately 0.18.

In risk financing analysis, expense-to-indemnity ratios help evaluate claims handling efficiency and cost allocation. Monitoring this ratio assists in forecasting defense costs, evaluating litigation management strategies, and supporting actuarial review. Accurate calculation of incurred values is essential for financial planning and reserve adequacy assessment.

Computerized Provider Order Entry (CPOE) reduces medication errors primarily by eliminating illegible handwriting, standardizing order fields, and enabling decision support (allergy checks, dosing ranges, interactions). Evidence indicates CPOE can significantly reduce prescribing errors and improve patient safety, though it can also introduce new error types (selection errors, alert fatigue), requiring careful design and monitoring. From a risk management perspective, CPOE is a high-impact control that strengthens medication safety defenses at the “front end” of the medication-use process. Risk objectives include governance for order sets, usability testing, monitoring override patterns, and continuous training to prevent workarounds. Properly implemented, CPOE supports safer, more reliable care and reduces preventable adverse drug events, aligning with enterprise safety goals and regulatory expectations for medication management.

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.

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, while parents generally serve as surrogate decision-makers for minors, their authority is not absolute. When refusal of treatment places a child at significant risk of serious harm or death, healthcare providers have an ethical and legal obligation to act in the best interests of the child.

In cases involving life-sustaining treatment for a premature infant, refusal of a medically necessary blood transfusion may constitute potential medical neglect if it threatens the infant’s survival. When disagreement persists after appropriate communication and ethics consultation, and the infant’s life is at risk, the appropriate step is to seek judicial intervention. Contacting legal counsel to obtain an emergency court order allows the state to exercise its parens patriae authority to protect the child’s welfare.

An ethics consultation may help clarify values and promote dialogue but does not override urgent medical necessity. Simply prohibiting or proceeding without legal authority exposes the organization to liability.

Legal and regulatory objectives emphasize protecting vulnerable patients while respecting due process. Therefore, seeking an emergency court order through legal counsel is the appropriate action.

Leaving an at-risk patient unattended during/after medication administration is typically anactive failureoccurring 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.

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, a 22-year-old patient is a legal adult and retains full rights to privacy and control over disclosure of protected health information under HIPAA and applicable state confidentiality laws. Psychiatric records are subject to heightened confidentiality protections in many jurisdictions.

Absent a court order or legal guardianship determination, a parent does not have automatic access to an adult child’s medical records. Therefore, before releasing any information, the organization must verify that the patient has executed a valid, specific authorization for release of information that complies with HIPAA requirements. The authorization must clearly identify the recipient, the information to be disclosed, and be properly signed and dated.

Consulting legal counsel or a treating psychiatrist does not substitute for proper authorization. Similarly, requesting guardianship documentation would only be appropriate if the mother asserts legal guardianship status; however, in the absence of such documentation, release cannot occur.

Legal and regulatory objectives emphasize strict adherence to privacy laws, protection of psychiatric records, and proper authorization procedures. Therefore, verification of a signed release of information from the patient is required before disclosure.

According to Health Care Risk Management standards supported by ASHRM and enterprise risk management ERM principles, external factors include conditions outside the direct control of the organization that influence strategic, operational, financial, and regulatory risk exposures.

A physician shortage is an external workforce market condition that can affect staffing stability, access to care, and malpractice exposure. New regulations are also external factors, as legislative or regulatory changes may alter compliance requirements, reimbursement structures, or reporting obligations. Similarly, soft insurance market trends reflect external economic and underwriting environments that influence premium pricing, availability of coverage, and risk financing strategy.

Resolution of claims, however, is generally an internal operational or claims management outcome. While influenced by external legal environments, the resolution process itself is primarily part of internal risk management and litigation strategy rather than a broad external environmental factor.

ERM objectives emphasize analysis of external environmental drivers, including regulatory, workforce, economic, and market conditions. Therefore, physician shortages, new regulations, and soft insurance market trends are external factors affecting risk, while resolution of claims is not primarily classified as external.

According to Health Care Risk Management standards outlined by ASHRM and the American Hospital Association Certification Center, a risk management policy and procedure manual should clearly define the structure, authority, and operational framework of the risk management program. An organizational chart is an essential component because it identifies reporting relationships, lines of authority, and accountability within the department and in relation to executive leadership and governing bodies.

A clearly documented organizational structure supports regulatory compliance, facilitates communication, and ensures that responsibilities for event reporting, claims management, patient safety initiatives, and regulatory oversight are properly assigned. It also demonstrates governance alignment and helps accrediting bodies evaluate program effectiveness.

Medical staff bylaws are separate governance documents that outline credentialing, peer review, and clinical governance standards. Actuarial reports are financial analyses used in risk financing decisions but are not part of a policy and procedure manual. Loss run reports summarize historical claims activity and support financial review but do not define program structure.

Health Care Operations objectives emphasize formal documentation of authority, processes, and accountability within the risk management framework. Therefore, inclusion of the department organizational chart is an essential element of a comprehensive risk management policy and procedure manual.

A safety audit must be anchored to explicitstandards—policies, regulatory requirements, evidence-based guidelines, and internal procedures—so observations can be evaluated objectively. Without defined criteria, the audit becomes subjective and inconsistent, limiting its usefulness and defensibility. Risk management objectives for ED audits include verifying compliance with high-risk workflows (triage, medication storage, high-alert meds, behavioral health safety, EMTALA processes, handoff communication, alarm management), identifying hazards (environmental risks, crowding, staffing mismatch), and ensuring corrective actions are tracked to closure. A written standard also supports repeatability—audits can be compared over time, and improvements can be measured. This approach aligns with quality management principles: define the requirement, assess the gap, implement controls, and monitor effectiveness.

Under Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, two federal laws are most directly implicated in this scenario: the Americans with Disabilities Act ADA and the Emergency Medical Treatment and Labor Act EMTALA, formerly enacted under COBRA.

EMTALA requires hospitals with emergency departments to provide an appropriate medical screening examination, stabilization of emergency medical conditions, and appropriate transfer or admission regardless of ability to pay. Since the emergency physician has evaluated and stabilized the patient and the on-call physician is being consulted for admission, EMTALA obligations remain central to ensuring compliant continuation of care.

The ADA is also directly relevant because it mandates that health care organizations provide reasonable accommodations to individuals with disabilities, including effective communication. For a patient requiring a sign language interpreter, the hospital must provide appropriate auxiliary aids and services to ensure meaningful access to care.

HIPAA relates primarily to privacy and protected health information, while HCQIA addresses peer review immunity and credentialing matters. Therefore, ADA and EMTALA are the most relevant regulatory frameworks in this case.

Marketing claims can create liability exposure when they reasonably induce reliance and the patient suffers harm. Depending on jurisdiction and facts, plaintiffs may allegeapparent agency(belief that physicians acted as the HMO’s agents),vicarious liability, negligent credentialing, or negligent misrepresentation/consumer protection claims if statements are misleading. Risk management objectives include reviewing public claims for accuracy, ensuring marketing does not overpromise clinical capability, and aligning network adequacy and credentialing with representations. Clear disclosures about independent contractors may help but do not always defeat apparent agency claims. Controls include legal review of advertising, credentialing rigor, quality oversight, and complaint surveillance to detect mismatches between marketing and actual service capability.

According to Health Care Risk Management standards endorsed by ASHRM and the American Hospital Association Certification Center, Failure Mode and Effects Analysis FMEA is a proactive patient safety tool used to identify and prioritize potential process failures before harm occurs. Within FMEA methodology, each potential failure mode is evaluated using three separate scoring components: severity, occurrence, and detection.

Severity measures the potential impact of the failure if it occurs. Occurrence assesses the likelihood that the failure will happen. Detection evaluates the probability that the failure will be identified before causing harm. Each component is typically assigned a numerical value based on predefined criteria.

The Risk Priority Number RPN is calculated by multiplying the three scores: severity multiplied by occurrence multiplied by detection. This multiplication approach produces a composite score that reflects both the seriousness of potential harm and the likelihood that the event will occur and escape detection. Higher RPN values indicate higher-priority risks requiring mitigation.

Clinical and patient safety objectives emphasize systematic risk prioritization to allocate resources effectively and reduce preventable adverse events. Therefore, the RPN is calculated by multiplying severity, occurrence, and detection scores.

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, insurance policy information is generally discoverable in litigation. Most jurisdictions require disclosure of applicable liability coverage, including policy limits, pursuant to civil procedure rules governing discovery. Therefore, when an interrogatory properly requests insurance policy information, the organization should provide the specifically requested information in coordination with defense counsel.

Providing more information than requested, such as automatically including excess limits if not asked, may exceed the scope of the interrogatory and should be guided by legal counsel. A certificate of insurance is not a substitute for responding to formal discovery requests, as it may not contain all required details regarding coverage, limits, and applicable policy periods.

Objecting to the interrogatory without valid legal grounds is generally inappropriate, as insurance coverage information is typically relevant to potential satisfaction of judgment.

Claims and litigation objectives emphasize cooperation with counsel, compliance with discovery rules, and accurate disclosure of coverage information. Therefore, the appropriate response is to provide the specifically requested insurance policy information in accordance with legal guidance.

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.

Inpatient suicide prevention is a high-stakes patient safety domain where RCAs frequently identifyenvironmental hazards—particularly ligature risks, blind spots, and unit design that limits observation. Joint Commission–style reviews and published analyses note that thephysical environmentis commonly “incriminated” in inpatient suicides, emphasizing design/engineering controls alongside clinical monitoring. Risk management objectives prioritize layered defenses: ligature-resistant fixtures, environmental rounding, safe room standards, removal control for risky items, and observation policies matched to patient risk. Environmental mitigation is especially powerful because it reduces reliance on perfect human vigilance (which is not realistic). By treating suicide prevention as a systems problem—not an individual failure—organizations improve reliability and reduce recurrence. Environmental corrections also strengthen regulatory readiness and demonstrate that the facility addressed known hazards with sustainable controls.

According to Health Care Risk Management principles supported by ASHRM and the American Hospital Association Certification Center, insurance coverage for liability exposures is often structured in layers. The first layer of insurance that responds to a covered loss is known as the primary policy.

Primary insurance provides initial coverage once any applicable deductible or self-insured retention has been satisfied. It is responsible for defense and indemnity payments up to the policy’s stated per-occurrence and aggregate limits. Only after the primary policy limits are exhausted do excess or umbrella policies respond.

Terms such as baseline, foundation, and frontline are not recognized technical classifications in layered insurance structures. In professional and general liability programs, organizations commonly maintain a primary layer followed by one or more excess layers to protect against catastrophic losses.

Risk financing objectives emphasize understanding policy structure, limits, attachment points, and coordination between layers to ensure adequate protection of organizational assets. Therefore, the correct term for the first layer of insurance that responds to a loss is the primary policy.

According to Health Care Risk Management standards supported by ASHRM and the American Hospital Association Certification Center, the CMS Hospital Conditions of Participation define a grievance as a formal or informal written or verbal complaint made by a patient or representative regarding care, abuse, neglect, compliance with regulations, or patient rights that is not resolved at the time of the complaint by staff present.

A verbal complaint that cannot be resolved immediately by current staff and whose resolution is postponed qualifies as a grievance under 42 CFR §482.12. Such grievances require formal investigation, documentation, and written response within established timeframes.

Billing issues generally fall outside the grievance definition unless they involve quality of care or patient rights concerns. Information from patient satisfaction surveys is not automatically classified as a grievance unless the patient specifically requests investigation or follow-up. Post-discharge verbal concerns may constitute grievances depending on context, but the key CMS criterion is whether the complaint could not be resolved at the time it was expressed.

Legal and regulatory objectives emphasize proper classification, timely response, documentation, and board oversight of grievance processes. Therefore, a verbal complaint that cannot be resolved immediately and is deferred meets CMS grievance criteria.

According to Health Care Risk Management standards supported by ASHRM and The Joint Commission National Patient Safety Goals, the read-back process is designed to ensure accurate communication of verbal or telephone orders. The correct process requires the person receiving the order to first write down the complete order and then read it back to the prescribing practitioner for verification.

Writing the order down before reading it back reduces reliance on memory and decreases the risk of omission or transcription errors. The practitioner who gave the order must then confirm that the read-back is accurate. This closed-loop communication process enhances patient safety and reduces medication and treatment errors associated with miscommunication.

Immediately repeating the information without documenting it does not meet the full verification requirement, as the written record must be confirmed. A witness is not required under the standard. Documenting the date and time is necessary for proper charting but does not constitute completion of the read-back verification itself.

Clinical and patient safety objectives emphasize clear, structured communication processes. Therefore, writing the information down before reading it back is the appropriate method to complete the verification process.

Under Health Care Risk Management standards aligned with ASHRM and the American Hospital Association Certification Center, employment interview questions must comply with federal and state anti-discrimination laws, including the Americans with Disabilities Act ADA, Title VII of the Civil Rights Act, the Pregnancy Discrimination Act, and the Immigration Reform and Control Act.

Questions about prescription medications may violate ADA provisions by eliciting information about potential disabilities prior to a conditional offer of employment. Asking whether a candidate plans to have children may constitute unlawful discrimination based on sex or family status. Inquiring directly about citizenship may violate federal employment eligibility standards; employers may instead ask whether the applicant is legally authorized to work in the United States.

In contrast, asking whether a candidate can meet the organization’s attendance requirements is permissible because it relates directly to essential job functions and business necessity. Employers may inquire about the ability to perform job-related duties, provided questions are applied consistently to all applicants and are not designed to screen out protected classes.

Legal and regulatory objectives emphasize nondiscriminatory hiring practices and adherence to equal employment laws. Therefore, questions regarding attendance requirements are appropriate in a job interview setting.

Verbal/telephone orders are widely recognized aserror-pronebecause they can be misheard, misunderstood, or transcribed incorrectly—especially with sound-alike drug names, confusing numerals (15 vs 50), background noise, accents, and interruptions. ISMP and patient safety advisories recommend minimizing verbal orders whenever possible and using safeguards such as read-back/confirm-back, spelling drug names, stating digits individually, and documenting promptly. Risk management objectives include reducing reliance on memory and imperfect communication by prioritizing written or electronic orders (CPOE), standardizing when verbal orders are permitted (true emergencies), and auditing compliance to prevent unsafe normalization. Because medication errors can cause severe harm, controlling verbal order risk is a high-yield safety intervention and improves legal defensibility by aligning practice with recognized safety recommendations.

Clear directives are specific, measurable, and time-bound—reducing ambiguity and variability that drive frontline error. “Monitor every so often” becomes safer when translated into a defined interval (e.g., every 15 minutes for the first hour, then hourly), with documentation requirements and escalation triggers. Risk management objectives emphasize standard work and reliable monitoring for high-risk equipment such as infusion pumps because device malfunction or programming errors can rapidly cause harm. Clear directives also support accountability and defensibility: they demonstrate the organization defined expectations and trained staff accordingly. Vague instructions (“be careful”) do not reliably change behavior or outcomes. In high-reliability care, clarity is a safety barrier: it reduces cognitive load, prevents missed steps, and improves handoffs between staff by making the plan visible and verifiable.

Access to NPDB information is restricted to authorized entities for credentialing, privileging, and oversight—not public browsing. HRSA’s NPDB rules identify who can query and report;professional societies with formal peer revieware listed among entities that may query under certain circumstances. This limited-access model supports patient safety objectives by enabling credentialing bodies to identify adverse licensure actions, certain negative clinical privilege actions, and other reportable events, while protecting due process and confidentiality. From a risk management perspective, proper querying supports defensible credentialing and reduces negligent credentialing exposure. Equally important: organizations must maintain secure handling of NPDB responses and follow permitted-use rules to avoid compliance violations.

RCA and systems safety models (e.g., Swiss Cheese) emphasize that adverse events typically requiremultiple contributing factors—small process breakdowns, latent conditions, and active failures—to align. This is why focusing only on the last person who touched the patient (“sharp end blame”) rarely prevents recurrence. Risk management objectives are to identify and strengthen defenses: policies, training, equipment design, staffing models, communication standards, and redundancy where needed. A series-of-events understanding enables targeted corrective actions (forcing functions, standardization, automation with safeguards, independent double checks for high-alert processes). It also supports just culture: accountability is preserved for reckless behavior, but most improvement comes from redesigning systems that make errors more likely. This approach improves reliability, reduces repeat harm, and provides defensible evidence of organizational learning and corrective action.

According to Health Care Risk Management standards established by ASHRM and the American Hospital Association Certification Center, the Patient Safety and Quality Improvement Act of 2005 amended the Public Health Service Act to promote voluntary reporting of patient safety events. The Act established a federal framework to encourage confidential reporting and analysis of medical errors in order to improve patient safety.

The law enabled the creation and certification of Patient Safety Organizations PSOs, which collect and analyze patient safety data submitted by healthcare providers. Importantly, the Act designates patient safety work product submitted to PSOs as privileged and confidential, providing federal legal protections against disclosure in most civil, criminal, or administrative proceedings. This privilege encourages candid reporting and system-wide learning.

However, reporting to PSOs is voluntary, not mandatory. The Act was specifically designed to foster participation by offering confidentiality protections rather than imposing compulsory reporting requirements.

Legal and regulatory objectives in healthcare risk management emphasize understanding the scope of federal protections and ensuring proper designation and handling of patient safety work product. Therefore, provisions 1, 2, and 4 are correct, while mandatory reporting to PSOs is not required under the Act.