{"id":254172,"date":"2022-10-16T07:55:15","date_gmt":"2022-10-16T07:55:15","guid":{"rendered":"https:\/\/nursingstudy.org\/?p=254172"},"modified":"2025-06-18T04:49:57","modified_gmt":"2025-06-18T04:49:57","slug":"regulatory-agencies-and-accrediting-bodies","status":"publish","type":"post","link":"https:\/\/nursingstudy.org\/examples\/regulatory-agencies-and-accrediting-bodies\/","title":{"rendered":"Regulatory Agencies and Accrediting Bodies &#8211; Week 2 Solution"},"content":{"rendered":"\n<p>This article discusses <strong>Regulatory Agencies and Accrediting Bodies<\/strong> in relation to community health.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Instructions<\/h2>\n\n\n\n<p>This assignment is designed to give you a greater understanding of regulatory agencies and accreditation bodies, including their functions, public reporting requirements, and the how they impact quality and safety.<\/p>\n\n\n\n<p><strong>Select<\/strong>&nbsp;and&nbsp;<strong>evaluate<\/strong>&nbsp;a regulatory agency or accrediting body.<\/p>\n\n\n\n<p>Discuss the history of the agency or body.<\/p>\n\n\n\n<p>Explain the reason for its existence.<\/p>\n\n\n\n<p>Summarize the agency\\&#8217;s public reporting of quality indicators:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Frequency<\/li><li>Where they are reported<\/li><li>Why public reporting of these metrics is important<\/li><\/ul>\n\n\n\n<p>Explain how the agency or body operates:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Current function<\/li><li>Organizational structure<\/li><li>Governance<\/li><\/ul>\n\n\n\n<p>Analyze the impact the agency or body has on quality at each level of health care:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/nursingstudy.org\/examples\/-what-if-anything-is-different-about-applying-basic-management-concepts-to-health-care-organizations-as-opposed-to-other-types-of-organizations-\/\">Health care organizations<\/a><\/li><li>Nursing practice<\/li><li><a href=\"https:\/\/nursingstudy.org\/examples\/how-have-you-seen-the-diverse-interests-of-healthcare-stakeholders-impact-patient-care-in-your-nursing-practice-or-in-the-practice-of-other-nurses\/\">Patient care<\/a><\/li><\/ul>\n\n\n\n<p><strong>Citeat least two sources in an APA-formatted reference page.<\/strong><\/p>\n\n\n\n<p><strong>Format&nbsp;your assignment as one of the following:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>875-word paper<\/strong><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Solution<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Regulatory Agencies and Accrediting Bodies<\/h3>\n\n\n\n<p>For this paper, I will discuss the USA Food and Drug Administration (FDA), a federal agency within the Department of Health and Human Services (DHHS).<\/p>\n\n\n\n<p><strong>History<\/strong><\/p>\n\n\n\n<p>The FDA was established in 1906 following the Pure Food and Drugs Act legislation (FDA, 2018-a). Harvey Washington Wiley is credited for driving the establishment of the legislation. As the principal chemist at the USDA Bureau of Chemistry, Harvey headed the enforcement of the FDA legislation. Over the years, the FDA has undergone socioeconomic, political, and legal changes, indicating its evolving role in promoting public health and providing a framework for evaluating contemporary regulatory challenges.&nbsp;<\/p>\n\n\n\n<p><strong>Reason for Existence<\/strong><\/p>\n\n\n\n<p>The primary function of the modern FDA was to illegalize the trade of adulterated and improperly branded drugs and food substances (FDA, 2018-a). However, the agency\u2019s responsibility has grown to include regulating the production, advertising, and distribution of various substances such as tobacco, food substances and guide innovations of effective, safe, and affordable production of medical products (FDA, 2018-b). Equally, the FDA provides deliberate, accurate, and scientific information to guide public consumptions of medical products and food to prevent emerging public health threats.<\/p>\n\n\n\n<p><strong>The FDA\u2019s Public Reporting of Quality Indicators<\/strong><\/p>\n\n\n\n<p>In January 2018, the FDA <a href=\"https:\/\/nursingstudy.org\/examples\/how-do-we-define-the-quality-of-health-care-is-it-the-outcome-or-the-experience-can-a-patient-receive-excellent-quality-of-care-and-have-a-bad-outcome-possibly-die-can-a-patient-receive-quality-medica\/\">received quality<\/a> metrics in line with its guidelines and published them in the Federal Register. The quality metric reporting is voluntary for drug and food manufactures. Quality metric reporting assists the FDA in developing compliance and audit <a href=\"https:\/\/nursingstudy.org\/examples\/describe-the-similarities-and-differences-of-these-organizations-in-terms-of-the-following-mission-goals-objectives-management-structure-reimbursement-models-staffing-policies-procedures-res\/\">policies and procedures<\/a> and informing hazard planning for&nbsp;drug manufacturing operations (FDA, 2020-b).<\/p>\n\n\n\n<p>The FDA\u2019s Drug Safety-related Labeling Changes&nbsp;(SrLC)&nbsp;database&nbsp;includes updates to safety information in the labeling for human prescription drugs regulated under New Drug Applications and human prescription biological products regulated under Biologics License Applications. Moreover, the FDA publishes the Food Code every four years (FDA, 2019), while the National Drug Code Directory numbers are updated daily (FDA, 2020-a). Therefore, the FDA must publicize quality metrics to monitor quality control processes and systems of the biologics and drug manufacturing industries.<\/p>\n\n\n\n<p><strong>FDA Operations<\/strong><\/p>\n\n\n\n<p>The FDA\u2019s <a href=\"https:\/\/nursingstudy.org\/examples\/the-protection-that-health-workers-addressing-the-pandemic-are-obliged-to-safeguard-against-the-risks-which-they-are-exposed-to-as-they-execute-their-duties-ethical-principles-of-protecting-healthcar\/\">duty is to protect the American Citizen\u2019s health<\/a> by regulating the safety and efficiency of medical and biological products and devices. The agency ensures the safety of citizens by regulating the supply of food, cosmetics, and radioactive electronic products&nbsp;(FDA, 2018-b). Other products regulated by the FDA include vaccines, tobacco products, and diet supplements&nbsp;(FDA, 2020-c). <\/p>\n\n\n\n<p>The FDA is made up of the Commissioner\u2019s Office and four directorates that oversee the agency\u2019s functional areas, namely Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations (FDA, 2020-d). Besides, the agency has nine&nbsp;central-level institutions and 13 headquarters (HQ) Offices. The commissioner is the central authority within the FDA and is termly appointed by the president.<\/p>\n\n\n\n<p id=\"block-3764e7e9-841c-44c0-88a7-754100a60e9f\">Are you looking for answers to a similar assignment?Nursingstudy.org has the top and most qualified writers to help with any of your assignments. All you need to do is&nbsp;place an order&nbsp;with us.(Regulatory Agencies and Accrediting Bodies)<\/p>\n\n\n\n<figure class=\"wp-block-image\" id=\"block-7b325dbd-7214-4ab6-9f79-b36ae52889ab\"><img decoding=\"async\" src=\"https:\/\/privateessaywriters.com\/wp-content\/uploads\/2022\/01\/order-1024x334.jpg\" alt=\"Regulatory Agencies and Accrediting Bodies\"\/><figcaption>Regulatory Agencies and Accrediting Bodies<\/figcaption><\/figure>\n\n\n\n<p>Moreover, the Senate provides the president with the advice and consent of the ultimately chosen commissioner. The commissioner works under and reports to&nbsp;the secretary of DHHS. Several statutory provisions passed by the United <a href=\"https:\/\/nursingstudy.org\/examples\/what-are-the-local-state-or-federal-health-care-laws-or-policies-that-set-these-benchmarks\/\">States Congress and construed by the agency per the Federal<\/a> Food, Drug, and Cosmetic Act govern the FDA\u2019s operations.<\/p>\n\n\n\n<p><strong>Impact of FDA on <\/strong>Healthcare<\/p>\n\n\n\n<p>The FDA institution affects the healthcare system in various ways. For example, the FDA databases contain data that assist healthcare organizations in making various healthcare-related decisions, such as medical prescriptions and the use of medical devices (FDA, 2021). <\/p>\n\n\n\n<p>The FDA invests in the appropriate <a href=\"https:\/\/nursingstudy.org\/examples\/describe-how-improved-communication-collaboration-and-teamwork-can-improve-conditions-in-your-department\/\">collaborative<\/a> partnerships with hospitals to educate them on its quality metrics requirements, i.e., for Medical Device Reporting (MDR) requirements to improve hospitals\u2019 reporting of the associated adverse events and promote the safe use of the medical devices (Barlas, 2017). The FDA works with other health organizations to advance public health by supporting and streamlining the development and evaluation of new drug products.<\/p>\n\n\n\n<p>While FDA does not regulate nursing practice, the agency FDA offers surveillance of medical devices and products\u2019 continuing efficacy and safety, allowing nurses to report adverse events (FDA, 2021). Equally, the FDA is involved in the assessment safety and effectiveness of new medical technology and food ingredients. The FDA also builds opportunities to harmonize existing knowledge, databases, and standards.<\/p>\n\n\n\n<p>In terms of patient care, The FDA\u2019s Center for Drug Evaluation and Research (CDER) guarantees the safety and efficacy of drugs that are available&nbsp;used by the USA population to improve their health&nbsp;(FDA, 2021). Moreover, the FDA provides guidelines for the use of drugs and&nbsp;medical devices without professional assistance. <\/p>\n\n\n\n<p>However, the agency influences how individuals can use medical devices safely and effectively. In this regard, the FDA contributes to health&nbsp;care for both hospitalized and home-based patients. The FDA conducts surveillance of approved and regulated medical products to <a href=\"https:\/\/nursingstudy.org\/examples\/ethical-responsibility-of-nurses-in-ensuring-patient-autonomy-beneficence-non-malfeasance-and-justice\/\">ensure the safety of patients<\/a>. The FDA promotes the availability of novel medical therapies for the US population. Therefore, the FDA protects patients from potential harm through these initiatives. Equally, the FDA is a significant agency fronting safe and quality <a href=\"https:\/\/nursingstudy.org\/examples\/public-health-nursing-practice-and-the-disaster-management-cycle\/\">public health practices<\/a> and services. <strong><br><\/strong><\/p>\n\n\n\n<p><strong>References<\/strong><\/p>\n\n\n\n<p>Barlas, S. (2017). FDA flags inconsistent hospital reporting of medical device problems: hazy reporting <a href=\"https:\/\/nursingstudy.org\/examples\/health-standards-rules-and-definitions-are-requirements-for-effective-and-efficient-electronic-health-records-ehrs-this-chapter-explains-various-options-for-these-areas-and-discusses-how-they-can\/\">rules<\/a> beget confusion.&nbsp;<em>Pharmacy and Therapeutics<\/em>,&nbsp;<em>42<\/em>(2), 97. <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5265235\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5265235\/<\/a> <strong><\/strong><\/p>\n\n\n\n<p>The US Food and Drug Administration. (March 2018-a). FDA History. Retrieved 14 July 2021, from <a href=\"https:\/\/www.fda.gov\/about-fda\/what-we-do\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/about-fda\/what-we-do<\/a><\/p>\n\n\n\n<p>The US Food and Drug Administration. (March 2018-b). What We Do. Retrieved 14 July 2021, from <a href=\"https:\/\/www.fda.gov\/about-fda\/what-we-do\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/about-fda\/what-we-do<\/a><\/p>\n\n\n\n<p>The U. S. Food and Drug Administration (December 2019). FDA Food Code. Retrieved 14 July 2021, from <a href=\"https:\/\/www.fda.gov\/food\/retail-food-protection\/fda-food-code\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/retail-food-protection\/fda-food-code<\/a><\/p>\n\n\n\n<p>The U. S. Food and Drug Administration (January 2020-b). Quality Metrics for Drug Manufacturing. Retrieved 14 July 2021, from <a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/quality-metrics-drug-manufacturing\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/quality-metrics-drug-manufacturing<\/a><\/p>\n\n\n\n<p>The U. S. Food and Drug Administration (December 2020-a). National Drug Code Directory. Retrieved 14 July 2021, from <a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/national-drug-code-directory\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/national-drug-code-directory<\/a><\/p>\n\n\n\n<p>The U. S. Food and Drug Administration (December 2020-c). Regulated Products. Retrieved 14 July 2021, from <a href=\"https:\/\/www.fda.gov\/industry\/import-basics\/regulated-products\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/industry\/import-basics\/regulated-products<\/a><\/p>\n\n\n\n<p>The U. S. Food and Drug Administration (December 2020-d) (January 2020-d). FDA Organization Chart. Retrieved 14 July 2021, from <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/fda-organization-charts\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/about-fda\/fda-organization\/fda-organization-charts<\/a><\/p>\n\n\n\n<p>The US Food and Drug Administration. (2021). Advancing Regulatory Science at FDA: <a href=\"https:\/\/nursingstudy.org\/examples\/select-3-peer-reviewed-articles-that-address-your-chosen-focus-area-for-your-capstone-project-and-create-3-5-goals-objectives-for-your-capstone-project-using-the-smart-goals-objective-format\/\">Focus Areas<\/a> of Regulatory Science (FARS).&nbsp; Retrieved 14 July 2021, from https:\/\/www.fda.gov\/media\/145001\/download<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Community Health Promotion Essay Examples<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Capella University Health Promotion Plan And Best Practices PPT<\/td><td>Discussion: NURSFPX4060 Capella University Health Promotion Plan and Best Practices PPT Health Promotion Plan<\/td><\/tr><tr><td>Health Promotion Plan Presentation<\/td><td>Health Promotion Plan Presentation<\/td><\/tr><tr><td><a href=\"https:\/\/premiumacademicaffiliates.com\/health-promotion-and-community-resource-teaching-project\/\" target=\"_blank\" rel=\"noreferrer noopener\">Health Promotion and Community Resource Teaching Project<\/a><\/td><td>Identify interdisciplinary health professionals important to include in the health promotion. What is their&nbsp;role? Why is their involvement significant?<\/td><\/tr><tr><td><a href=\"https:\/\/customnursingassignments.com\/identify-a-health-problem-or-need-for-health-promotion-for-a-particular-stage-in-the-life-span-of-a-population-2\/\" target=\"_blank\" rel=\"noreferrer noopener\">Identify a health problem or need for health promotion for a particular stage in the life span of a population<\/a><\/td><td>PURPOSE To apply concepts you have learned about health promotion concepts and strategies, enhance your written communication skills, and demonstrate a beginning understanding of cultural competency.&nbsp;<\/td><\/tr><tr><td>Pender Health Promotion Model<\/td><td>Pender Health Promotion Model<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Read More:<\/h2>\n\n\n\n<p>Public Health Nursing Roles and Responsibilities in Disaster Response \u2013 Assignment 2 Solution<\/p>\n\n\n\n<p>Quality and Safety in Practice \u2013 Week 4 Solution<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This article discusses Regulatory Agencies and Accrediting Bodies in relation to community health. Instructions This assignment is designed to give you a greater understanding of regulatory agencies and accreditation bodies,&hellip;<\/p>\n","protected":false},"author":9,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_wpscppro_dont_share_socialmedia":false,"_wpscppro_custom_social_share_image":0,"_facebook_share_type":"","_twitter_share_type":"","_linkedin_share_type":"","_pinterest_share_type":"","_linkedin_share_type_page":"","_instagram_share_type":"","_medium_share_type":"","_threads_share_type":"","_google_business_share_type":"","_selected_social_profile":[],"_wpsp_enable_custom_social_template":false,"_wpsp_social_scheduling":{"enabled":false,"datetime":null,"platforms":[],"status":"template_only","dateOption":"today","timeOption":"now","customDays":"","customHours":"","customDate":"","customTime":"","schedulingType":"absolute"},"_wpsp_active_default_template":true},"categories":[1061,1],"tags":[],"class_list":["post-254172","post","type-post","status-publish","format-standard","hentry","category-nursing-essays","category-nursing-paper"],"_links":{"self":[{"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/posts\/254172","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/comments?post=254172"}],"version-history":[{"count":32,"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/posts\/254172\/revisions"}],"predecessor-version":[{"id":279679,"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/posts\/254172\/revisions\/279679"}],"wp:attachment":[{"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/media?parent=254172"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/categories?post=254172"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nursingstudy.org\/examples\/wp-json\/wp\/v2\/tags?post=254172"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}