Scenario Analysis: This scenario presents a professional challenge because it requires a nuanced understanding of the specific purpose and eligibility criteria for the Applied Caribbean Medical Hematology and Cellular Therapy Quality and Safety Review. Misinterpreting these criteria can lead to inefficient resource allocation, potential non-compliance, and ultimately, a failure to improve patient care and safety within the Caribbean region’s hematology and cellular therapy services. The challenge lies in distinguishing between general quality improvement initiatives and those specifically mandated or supported by this particular review process. Correct Approach Analysis: The best approach involves a thorough examination of the official documentation outlining the Applied Caribbean Medical Hematology and Cellular Therapy Quality and Safety Review. This documentation will detail the review’s objectives, scope, and the specific types of services, institutions, or patient populations that are eligible for participation or assessment. Adhering strictly to these defined parameters ensures that efforts are focused on areas directly addressed by the review, maximizing its impact and ensuring compliance with any associated guidelines or standards. This aligns with the principle of targeted quality improvement, ensuring that resources are directed towards the most relevant and impactful areas as defined by the review’s mandate. Incorrect Approaches Analysis: One incorrect approach is to assume that any quality improvement activity within a Caribbean hematology or cellular therapy setting is automatically eligible for or aligned with the review’s purpose. This overlooks the specific focus and scope of the review, potentially leading to the inclusion of initiatives that are outside its purview, thus wasting valuable time and resources. Another incorrect approach is to prioritize initiatives based solely on perceived urgency or local demand without first verifying their alignment with the review’s stated objectives and eligibility criteria. While local needs are important, the review has a defined purpose, and initiatives not fitting this purpose will not be effectively addressed by it. A further incorrect approach is to interpret the review’s purpose too broadly, encompassing all aspects of hematology and cellular therapy without considering the specific quality and safety dimensions that the review is designed to assess. This can lead to a diluted focus and an inability to achieve meaningful improvements in the targeted areas. Professional Reasoning: Professionals should adopt a systematic decision-making framework when assessing eligibility for quality and safety reviews. This framework involves: 1. Identifying the specific review or initiative in question. 2. Locating and thoroughly reviewing all official documentation related to its purpose, scope, objectives, and eligibility criteria. 3. Critically evaluating proposed quality improvement activities against these defined criteria. 4. Seeking clarification from the review’s governing body or administrators if any ambiguity exists. 5. Prioritizing and implementing activities that demonstrably meet the eligibility requirements and contribute to the review’s stated goals.

Scenario Analysis: This scenario presents a professional challenge in diagnostic reasoning and imaging selection within the context of Caribbean medical hematology and cellular therapy. The core difficulty lies in balancing the need for timely and accurate diagnosis with the judicious use of resources and patient safety, particularly in a region that may have varying access to advanced imaging technologies. The physician must navigate potential biases in diagnostic interpretation, ensure adherence to established quality and safety protocols, and make informed decisions about imaging modalities that are both effective and appropriate for the patient’s condition and the available infrastructure. Correct Approach Analysis: The best professional practice involves a systematic, evidence-based approach that prioritizes clinical correlation and patient presentation. This begins with a thorough clinical assessment, including a detailed patient history and physical examination, to formulate a differential diagnosis. Based on this, the physician selects the most appropriate initial imaging modality that offers the highest diagnostic yield for the suspected condition, considering factors like sensitivity, specificity, and potential risks. Subsequent imaging or more advanced techniques are then employed only if the initial investigation is inconclusive or if the clinical picture evolves. This approach aligns with principles of good medical practice, emphasizing patient-centered care, efficient resource utilization, and minimizing unnecessary procedures, thereby upholding ethical obligations to avoid harm and provide competent care. Incorrect Approaches Analysis: One incorrect approach involves defaulting to the most advanced or comprehensive imaging technique available without a clear clinical indication. This fails to adhere to the principle of proportionality in medical investigations. It can lead to unnecessary patient exposure to radiation or contrast agents, increased costs, and potential delays in diagnosis if the advanced imaging reveals incidental findings that distract from the primary pathology. Ethically, it violates the duty to avoid harm and use resources responsibly. Another flawed approach is to rely solely on imaging findings without integrating them with the clinical context. This can lead to misinterpretation of results, especially if imaging findings are non-specific or if subtle clinical cues are overlooked. It bypasses the critical step of clinical correlation, which is fundamental to accurate diagnostic reasoning and can result in incorrect diagnoses and inappropriate treatment plans, contravening the ethical imperative of providing competent medical care. A further incorrect approach is to select imaging based on physician preference or familiarity rather than the specific diagnostic question and the evidence supporting the efficacy of different modalities for that question. This introduces personal bias into the decision-making process and may not represent the most effective or safest diagnostic pathway for the patient. It deviates from evidence-based medicine and the professional responsibility to provide the best possible care. Professional Reasoning: Professionals should employ a structured diagnostic reasoning process. This involves: 1. Gathering comprehensive clinical information (history, physical exam, initial laboratory results). 2. Formulating a differential diagnosis. 3. Identifying the key diagnostic questions that need to be answered. 4. Selecting the most appropriate diagnostic test (including imaging) based on its ability to answer those questions, its safety profile, its cost-effectiveness, and its availability. 5. Interpreting test results in the context of the clinical presentation. 6. Revising the differential diagnosis and treatment plan as needed. This iterative process ensures that diagnostic decisions are logical, evidence-based, and patient-focused.

Scenario Analysis: This scenario presents a professional challenge due to the inherent complexity of ensuring consistent quality and safety in cellular therapy, particularly when dealing with novel or investigational treatments. The need to balance rapid advancement with rigorous oversight requires careful judgment to protect patient well-being while fostering innovation. The core of the challenge lies in interpreting and applying existing quality and safety frameworks to a dynamic field where best practices are still evolving. Correct Approach Analysis: The best professional practice involves a proactive and comprehensive review of all available quality and safety data, including preclinical, clinical, and manufacturing information, against established regulatory standards and institutional protocols. This approach prioritizes a thorough understanding of the product’s characteristics, potential risks, and the robustness of the manufacturing process. It aligns with the fundamental ethical obligation to ensure patient safety and the regulatory requirement for evidence-based decision-making in approving or continuing investigational therapies. This systematic evaluation ensures that all aspects of quality and safety are considered before proceeding, minimizing potential harm. Incorrect Approaches Analysis: One incorrect approach involves solely relying on the enthusiasm and preliminary positive outcomes presented by the research team. This overlooks the critical need for independent verification of data, a thorough risk-benefit assessment, and adherence to established regulatory pathways. It represents an ethical failure to adequately protect patients by potentially bypassing necessary safety checks. Another unacceptable approach is to approve the therapy based on its novelty and potential to address an unmet medical need without a comprehensive review of its safety profile and manufacturing controls. This prioritizes innovation over patient safety, which is a direct contravention of regulatory mandates and ethical principles governing medical research and treatment. A further flawed approach is to defer the decision entirely to external regulatory bodies without conducting an internal, rigorous quality and safety review. While external approval is necessary, institutions have a primary responsibility to ensure that therapies offered under their purview meet the highest standards of quality and safety, based on their own thorough evaluation. This abdication of internal responsibility can lead to the introduction of therapies that, while perhaps approved elsewhere, may not be suitable or adequately monitored within the specific institutional context. Professional Reasoning: Professionals should adopt a systematic, evidence-based decision-making framework. This involves: 1) Clearly defining the quality and safety objectives for the cellular therapy. 2) Gathering and critically evaluating all relevant data, including preclinical studies, clinical trial results, manufacturing process validation, and quality control metrics. 3) Comparing this data against established regulatory guidelines (e.g., from relevant health authorities and professional bodies), institutional policies, and ethical principles. 4) Conducting a thorough risk-benefit analysis, considering potential harms and benefits to patients. 5) Documenting the review process and the rationale for the decision. 6) Establishing robust monitoring and reporting mechanisms for ongoing safety surveillance.

Scenario Analysis: This scenario presents a professional challenge due to the inherent tension between the need for timely patient care and the imperative to adhere to established quality and safety protocols. In the context of Caribbean Medical Hematology and Cellular Therapy, where patient outcomes can be critically dependent on precise procedures and robust quality control, any deviation from established standards, even with good intentions, carries significant risks. The pressure to expedite treatment while maintaining the highest safety standards requires careful judgment and a deep understanding of regulatory expectations. Correct Approach Analysis: The best professional practice involves a structured, documented approach to addressing potential deviations. This includes immediate reporting of the incident to the relevant quality assurance and safety committees, followed by a thorough root cause analysis. This approach is correct because it aligns with the fundamental principles of quality management systems mandated by regulatory bodies and professional guidelines in healthcare. Such systems are designed to identify systemic issues, prevent recurrence, and ensure continuous improvement in patient safety and care delivery. The emphasis is on transparency, accountability, and learning from errors, rather than punitive measures. This proactive and systematic investigation ensures that patient safety remains paramount while also fostering a culture of safety within the institution. Incorrect Approaches Analysis: One incorrect approach involves attempting to rectify the situation internally without formal reporting, perhaps by discreetly re-processing the sample. This is professionally unacceptable because it bypasses established quality control mechanisms and regulatory reporting requirements. It creates a hidden deviation, preventing a proper assessment of the potential impact on the patient and hindering any systemic improvements that might be identified through a formal investigation. This approach undermines the integrity of the quality and safety framework and could lead to undetected patient harm. Another incorrect approach is to proceed with the treatment without any acknowledgment of the deviation, assuming the impact is negligible. This is ethically and regulatorially unsound. It disregards the principle of informed consent, as the patient and treating physician are not aware of a potential compromise in the diagnostic or therapeutic process. Furthermore, it fails to meet the standards of care and quality assurance expected in specialized medical fields, potentially leading to misdiagnosis, ineffective treatment, or adverse events that could have been prevented with proper protocol adherence and investigation. A third incorrect approach is to solely focus on blaming the individual staff member responsible for the error. While accountability is important, an overemphasis on individual blame without a systemic investigation is professionally inadequate. Regulatory frameworks and quality management principles emphasize identifying the contributing factors within the system, such as inadequate training, flawed procedures, or environmental issues, rather than solely attributing fault to an individual. This approach fails to address the root causes of the deviation and therefore does not contribute to preventing future occurrences. Professional Reasoning: Professionals in this field should employ a decision-making process that prioritizes patient safety and regulatory compliance. This involves: 1) Recognizing and acknowledging any deviation from established protocols immediately. 2) Following institutional procedures for reporting such deviations to the appropriate quality and safety oversight bodies. 3) Participating actively and transparently in any subsequent investigations, providing factual information without bias. 4) Focusing on understanding the systemic factors that may have contributed to the deviation to implement corrective and preventive actions. 5) Upholding ethical principles of honesty, integrity, and patient advocacy throughout the process.

This scenario presents a professional challenge due to the critical need to balance patient safety, adherence to established quality protocols, and the potential for rapid dissemination of life-saving cellular therapies. The pressure to adopt new, potentially beneficial treatments must be rigorously assessed against existing safety frameworks to prevent harm. Careful judgment is required to ensure that innovation does not outpace validated safety measures. The best approach involves a systematic, evidence-based evaluation of the novel cellular therapy within the existing regulatory and quality framework. This entails a thorough review of preclinical and early clinical data, comparison with established treatment protocols, and consultation with relevant institutional review boards and regulatory bodies. The focus is on ensuring that any new therapy meets stringent safety and efficacy standards before widespread adoption, aligning with the principles of good clinical practice and patient welfare. This methodical process safeguards against introducing unproven or potentially harmful treatments, upholding the highest standards of medical care and regulatory compliance. An incorrect approach would be to prioritize the perceived novelty or potential patient benefit of the cellular therapy over established safety protocols. This could manifest as bypassing or inadequately performing the required safety and efficacy assessments, or proceeding with treatment based on anecdotal evidence or preliminary, unverified data. Such actions would violate regulatory mandates for drug and therapy approval, as well as ethical obligations to ensure patient safety. Furthermore, failing to document and report adverse events or treatment outcomes comprehensively would undermine the learning process and hinder the development of safe and effective therapies, potentially leading to regulatory sanctions and loss of public trust. Another unacceptable approach would be to delay the evaluation and potential adoption of the therapy indefinitely due to institutional inertia or resistance to change, even in the face of compelling preliminary evidence of benefit and safety. While caution is necessary, an overly conservative stance that prevents access to potentially life-saving treatments without a clear, evidence-based rationale for delay is also professionally problematic. This could be considered a failure to act in the best interest of patients who could benefit from the therapy, and may also contraindicate the spirit of advancing medical science within a regulated environment. Professionals should employ a decision-making framework that prioritizes patient safety and regulatory compliance while fostering responsible innovation. This involves: 1) Thoroughly understanding the existing regulatory landscape and quality standards for cellular therapies. 2) Critically appraising all available scientific data, including preclinical and clinical evidence, for both efficacy and safety. 3) Engaging in open communication and collaboration with regulatory authorities, ethics committees, and multidisciplinary clinical teams. 4) Implementing robust monitoring and reporting systems for all treatments, especially novel ones. 5) Adopting a balanced approach that allows for the timely integration of validated, safe, and effective new therapies while mitigating risks.

The scenario presents a professional challenge in ensuring fairness and transparency in the assessment process for a critical medical certification. The challenge lies in balancing the need for rigorous evaluation with the potential for candidate anxiety and the impact of retake policies on professional development and patient safety. Careful judgment is required to implement a blueprint, scoring, and retake policy that is both equitable and upholds the high standards of Caribbean medical hematology and cellular therapy. The best professional approach involves a transparent and clearly communicated blueprint that accurately reflects the scope of practice and the weighting of different knowledge domains. This blueprint should be developed collaboratively with subject matter experts and regularly reviewed to ensure its continued relevance. Scoring should be objective and consistently applied, with a defined passing threshold. The retake policy should be designed to provide candidates with opportunities for remediation and re-assessment without compromising the integrity of the certification. This policy should clearly outline the number of retakes allowed, the timeframes between attempts, and any required remedial training. Such an approach is correct because it aligns with principles of fairness, due process, and professional accountability. It ensures that candidates are assessed on relevant competencies and have a clear understanding of the expectations and pathways for achieving certification, ultimately contributing to the quality and safety of patient care. An incorrect approach would be to implement a blueprint that is vague or does not accurately reflect the current practice of Caribbean medical hematology and cellular therapy. This fails to provide candidates with adequate guidance and can lead to assessments that are not truly representative of required knowledge and skills. Furthermore, a scoring system that is subjective or inconsistently applied undermines the validity of the examination and can lead to unfair outcomes. A retake policy that is overly restrictive, allowing only one attempt or imposing excessively long waiting periods between retakes without clear remedial pathways, can unfairly penalize otherwise competent individuals and hinder their ability to contribute to the field. Alternatively, a retake policy that is too lenient, allowing unlimited attempts without mandatory remediation, could compromise the overall standard of certified professionals. Professionals should employ a decision-making framework that prioritizes transparency, fairness, and evidence-based practice when developing and implementing assessment policies. This involves seeking input from stakeholders, conducting regular reviews of assessment tools and policies, and ensuring that all policies are clearly communicated to candidates well in advance of any examination. The ultimate goal is to create an assessment system that accurately measures competence and promotes continuous improvement in the field, thereby safeguarding patient safety.

The review process indicates a need for robust candidate preparation for the Applied Caribbean Medical Hematology and Cellular Therapy Quality and Safety Review. This scenario is professionally challenging because effective preparation directly impacts patient safety and the integrity of cellular therapy services. Misinformation or inadequate preparation can lead to a failure to identify critical quality and safety gaps, potentially jeopardizing patient outcomes and regulatory compliance within the Caribbean healthcare landscape. Careful judgment is required to ensure candidates are equipped with the most relevant and up-to-date information. The best approach involves a structured, multi-faceted preparation strategy that prioritizes official guidelines and evidence-based practices. This includes dedicating significant time to reviewing the specific regulatory framework governing medical hematology and cellular therapy in the Caribbean region, alongside established international quality and safety standards relevant to the field. Candidates should actively engage with peer-reviewed literature, case studies, and accredited continuing professional development modules that focus on quality improvement initiatives and risk management in cellular therapy. This comprehensive strategy ensures a deep understanding of both local requirements and global best practices, fostering a proactive and informed approach to quality and safety. An approach that relies solely on anecdotal experience or outdated personal notes is professionally unacceptable. This fails to account for evolving regulatory requirements and scientific advancements, potentially leading to the perpetuation of suboptimal practices. Such a method lacks the rigor necessary to ensure adherence to current standards of care and may result in the overlooking of critical safety protocols mandated by regional health authorities. Another professionally unacceptable approach is to focus exclusively on memorizing past examination questions without understanding the underlying principles. While familiarity with question formats can be helpful, this method does not cultivate the critical thinking and problem-solving skills essential for real-world application of quality and safety principles in a complex medical setting. It risks producing candidates who can pass a test but are not truly prepared to implement or uphold high standards in practice. Finally, an approach that prioritizes breadth over depth, attempting to cover a vast array of topics superficially without deep engagement with core quality and safety concepts, is also flawed. This can lead to a superficial understanding, leaving candidates ill-equipped to address nuanced challenges or to critically evaluate the effectiveness of different quality and safety interventions. Professionals should adopt a decision-making framework that emphasizes continuous learning, evidence-based practice, and adherence to regulatory mandates. This involves actively seeking out and integrating the latest guidelines, engaging in critical self-assessment of knowledge gaps, and prioritizing preparation methods that foster deep conceptual understanding and practical application of quality and safety principles relevant to Caribbean medical hematology and cellular therapy.

Scenario Analysis: This scenario presents a professional challenge because it requires balancing the immediate need for effective patient care with the long-term implications of treatment decisions on cellular health and potential future therapeutic options. The integration of foundational biomedical sciences with clinical medicine is paramount, demanding a nuanced understanding of how current interventions might impact cellular function and viability, especially in the context of hematology and cellular therapy. Careful judgment is required to avoid short-sighted decisions that could compromise the integrity of cellular material for future research or autologous/allogeneic transplantation. Correct Approach Analysis: The best professional practice involves a comprehensive assessment that prioritizes the collection and preservation of high-quality cellular material for potential future use, while simultaneously ensuring the patient receives appropriate and timely clinical management. This approach recognizes that cellular therapies are rapidly evolving, and preserving viable, well-characterized cellular products today can unlock future treatment possibilities for the patient or contribute to broader scientific advancement. This aligns with ethical principles of beneficence and non-maleficence, extending care beyond immediate needs to consider future well-being and the responsible stewardship of biological resources. It also implicitly supports the principles of good clinical practice and research integrity, ensuring that any collected material meets stringent quality standards. Incorrect Approaches Analysis: One incorrect approach would be to solely focus on immediate clinical symptom management without considering the impact on cellular viability or the potential for future cellular therapy. This fails to uphold the principle of beneficence by not maximizing the patient’s long-term therapeutic potential and could lead to the irreversible loss of valuable cellular material that might have been used for future treatments or research. Another incorrect approach would be to prioritize the collection of cellular material for research purposes above the patient’s immediate clinical needs. This violates the principle of non-maleficence by potentially delaying or compromising essential treatment, and it also raises ethical concerns regarding patient autonomy and the primary duty of care. A further incorrect approach would be to collect cellular material without adequate characterization or quality control, rendering it unsuitable for future therapeutic or research applications. This represents a failure in professional responsibility and a waste of resources, undermining the goals of cellular therapy and potentially misleading future investigations. Professional Reasoning: Professionals should adopt a decision-making framework that integrates a thorough understanding of the patient’s current clinical status with a forward-looking perspective on cellular health and therapeutic potential. This involves: 1) Assessing the immediate clinical necessity of interventions and their potential impact on cellular material. 2) Evaluating the quality and quantity of available cellular material for potential future use. 3) Consulting relevant guidelines and ethical principles governing the collection, preservation, and use of cellular products. 4) Engaging in shared decision-making with the patient, explaining the rationale behind different approaches and their implications. 5) Collaborating with multidisciplinary teams, including hematologists, cellular therapists, and laboratory specialists, to ensure optimal outcomes.

This scenario is professionally challenging because it requires balancing the physician’s medical expertise with the patient’s autonomy and values, particularly when dealing with complex and potentially life-altering treatment decisions in hematology and cellular therapy. The inherent uncertainty in these advanced treatments, coupled with the emotional and psychological impact on patients and their families, necessitates a highly sensitive and collaborative approach. Careful judgment is required to ensure that the patient’s understanding is adequate for informed consent, while also respecting their right to make decisions aligned with their personal beliefs and goals of care. The best approach involves a structured, empathetic, and iterative process of shared decision-making. This begins with clearly and comprehensively explaining the diagnosis, prognosis, and all available treatment options, including the risks, benefits, and uncertainties associated with each. Crucially, it requires actively eliciting the patient’s and caregiver’s values, preferences, and goals for treatment. This involves asking open-ended questions, listening attentively to their concerns, and addressing any misunderstandings or fears. The healthcare professional then works collaboratively with the patient and caregiver to weigh the options against their stated values, ultimately arriving at a mutually agreed-upon treatment plan. This aligns with ethical principles of patient autonomy and beneficence, and is supported by guidelines emphasizing patient-centered care and informed consent in complex medical situations. An approach that prioritizes the physician’s recommendation without thoroughly exploring the patient’s values and preferences fails to uphold the principle of patient autonomy. While the physician’s expertise is vital, it should not override the patient’s right to self-determination. This approach risks imposing a treatment plan that may not align with the patient’s life goals or may cause undue distress. Another unacceptable approach is to present all information in a purely technical manner, assuming the patient and caregiver possess the necessary medical literacy to fully comprehend the implications. This can lead to a superficial understanding and an illusion of informed consent, rather than genuine shared decision-making. It neglects the ethical obligation to ensure comprehension and support the patient’s decision-making capacity. Finally, an approach that defers the decision entirely to the caregiver without direct and thorough engagement with the patient, especially if the patient has decision-making capacity, is ethically problematic. While caregiver involvement is important, the primary right to decide rests with the patient. This approach undermines the patient’s autonomy and may not accurately reflect their wishes. Professionals should employ a decision-making framework that prioritizes open communication, active listening, and collaborative goal-setting. This involves assessing the patient’s understanding, identifying their values and preferences, presenting all relevant information in an accessible manner, and jointly developing a treatment plan that respects both medical evidence and individual patient circumstances.

Scenario Analysis: This scenario presents a common challenge in hematology and cellular therapy: balancing established evidence-based guidelines with the unique clinical presentation and potential resource limitations of a patient. The professional challenge lies in ensuring that the management plan is not only clinically effective but also ethically sound and compliant with regional healthcare standards, particularly concerning the “evidence-based management of acute, chronic, and preventive care” within the Caribbean context. The need for careful judgment arises from the potential for individual patient factors to necessitate deviations from standard protocols, requiring a nuanced approach that prioritizes patient safety and optimal outcomes while adhering to quality and safety review principles. Correct Approach Analysis: The best professional practice involves a comprehensive assessment of the patient’s acute condition, considering their chronic hematological status and any relevant preventive care needs, and then formulating a management plan that is directly supported by current, peer-reviewed evidence and relevant regional clinical guidelines. This approach prioritizes patient safety and efficacy by grounding treatment decisions in established scientific consensus and regulatory frameworks specific to the Caribbean healthcare landscape. It ensures that interventions are not only appropriate for the immediate clinical need but also integrated into a holistic, long-term care strategy, aligning with the principles of quality and safety review by minimizing risks associated with unproven or outdated treatments. Incorrect Approaches Analysis: One incorrect approach involves prioritizing a novel, unproven treatment based on anecdotal evidence or preliminary research without robust clinical validation. This fails to meet the evidence-based standard, potentially exposing the patient to unknown risks and suboptimal outcomes, and contravenes the principles of quality and safety review which mandate the use of treatments with demonstrated efficacy and safety. Another incorrect approach is to solely rely on historical treatment protocols that may no longer reflect current best practices or evidence. While historical data can inform understanding, management must evolve with scientific advancements. Sticking to outdated methods without re-evaluation can lead to suboptimal care and may not align with contemporary quality and safety expectations. A further incorrect approach is to tailor the management plan primarily based on the availability of specific local resources without first establishing the evidence-based standard of care. While resource constraints are a practical consideration, they should not dictate the initial determination of optimal care. The evidence-based standard should be established first, and then resource limitations should be addressed through careful planning, consultation, and potentially seeking alternative solutions, rather than compromising the fundamental quality of care. Professional Reasoning: Professionals should adopt a systematic decision-making process that begins with a thorough patient assessment, encompassing acute needs, chronic conditions, and preventive considerations. This assessment should then be cross-referenced with the most current, high-quality evidence and relevant regional guidelines. Any proposed interventions must be critically evaluated for their evidence base, safety profile, and potential benefits and harms. When resource limitations arise, the professional’s role is to advocate for the best possible care within those constraints, exploring all available options and engaging in transparent communication with the patient and relevant stakeholders. The overarching principle is to always strive for care that is evidence-based, safe, effective, and ethically delivered, in accordance with established quality and safety review processes.