Identify regulatory agencies that regulate health and the health care system within the US, create a table listing your 5 regulatory agencies and address the following:

1. Describe the agency, level of regulatory authority (local, state, federal), scope of regulatory authority, and role within the US healthcare system.

2. Address relevance of the organization or the organization’s authority to the APRN/DNP graduate.

3. Describe relevance to specialty area, area of practice, or setting of practice. For an example, mental health. 

Agency Synopsis

Identify regulatory agencies that regulate health and the health care system within the US, create a table listing your 5 regulatory agencies and address the following:

1. Describe the agency, level of regulatory authority (local, state, federal), scope of regulatory authority, and role within the US healthcare system.

2. Address relevance of the organization or the organization’s authority to the APRN/DNP graduate.

3. Describe relevance to specialty area, area of practice, or setting of practice. For an example, mental health. 


Submission Requirements:

· In the table, write the 3 criteria above and respond to them.

· The table is to be clear and concise and students will lose points for improper grammar, punctuation and misspelling.

· The table is to be complete and thorough. It should include all items indicated in the assignment.

· Incorporate at least 3 current (published within last five years) scholarly journal articles or primary legal sources (statutes, court opinions) within your work. 

· Complete and submit the chart by 11:59 PM ET Sunday.




Regulatory Agencies

Anna K. Rodriguez

St. Thomas University

Health Regulatory Agencies

Center for Disease Control

The CDC is a national-level regulatory authority and fundamentally focuses on the prevention and response of emergent infections. However, it collaborates with various local, state, and international partners who help in achieving core objectives of monitoring and preventing disease outbreaks. Again, they also cooperate in implementing various infection prevention measures and conserving national health statistics (Tappero et al., 2017). CDC also focuses on core strategic areas in the U.S. government, which include enhancing support to national and state-level healthcare divisions, improvement of global health, and the decrease of the core causes of death. Other aspects involve strengthening the monitoring of emerging infections or conditions and epidemiology, and reformation of healthcare policies. Therefore, CDC is a firm advocate of essential public health legislation. The functions of the agency can help APRNs to identify practical methods of treatment or condition management in instances of emergencies concerning rare ailments. Similarly, the CDC research and capabilities in dealing with complex and emerging diseases can be utilized to develop new pharmacological or alternative treatment approaches for individuals with rare mental or behavioral conditions.

Food and Drug Administration

FDA is a national-level controlling body. The institution has the mandate of inspecting, testing, approving, and setting the safety standards regarding foods, additives added to foods, drugs, chemical elements, cosmetic products, and devices in the healthcare sector. FDA maintains public health by assuring the safety of human drugs or other chemical or biological products. The body also supports research and innovations aimed at enhancing the safety and cost-effectiveness of foods and medicine. Learning and comprehending the standards distinguished by the FDA would enable an APRN to understand various practical limits such as the controlled drugs that can be prescribed to patients. In the case of mental health care, FDA monitors pharmacotherapy drugs offered to patients to ensure safe medicines are administered.

United States Agency for Toxic Substances and Disease Registry

ATSDR is a national-level regulatory agency. The body is responsible for protecting the public against hazardous elements. ATSDR protects states and local communities from the adverse consequences associated with exposure to natural or human-made dangerous elements (Holler, 2013). The agency fulfills its objective through response to environmental health-related emergencies, investigation of developing ecological health threats, implementation of research regarding the public health effects of hazardous waste locations, and provision of practical guidance to states and local communities. The purpose of the agency is relevant even to APRNs as it enables them to identify clear guidelines regarding the safe controlled substances that can be administered or prescribed during care. Again, the agency in mental care services ensures that patients are offered safe antidepressant or antipsychotic drugs and mood stabilizers.

Office of Health Care Quality

The division is a state-specific regulatory authority whose functions and mandates are limited to Maryland. The division is under the Maryland Department of Health, and its primary objective is to monitor the quality of care within the state’s medical institutions and community-oriented health programs. The regulatory authority offers licensure and certifications to medical institutions in the state. Licensure by the body allows facilities to operate in Maryland while certification focuses on authorizing amenities to engage in Medicare and Medicaid programs. The body is important to APRNs as it assures them that the institution, they work in within Maryland is in line with set performance and compliance standards. The agency helps in ensuring that medical practitioners in mental health institutions possess the needed aptitudes and licensure.

The Joint Commission

The agency is not a federal division but acts as a national and state regulatory authority. They are involved in the accreditation of healthcare institutions dealing with intense or advanced care services (Chaffee, 2015). The agency establishes and monitors compliance with performance standards. Again, the entity engages in recurrent monitoring of states’ legislative and regulatory processes to identify further opportunities for states’ reliance on its accreditations or certifications (Jha, 2018). A state can involve the Joint Commission as a central strategy of quality oversight processes. The accreditation process helps APRNs receive assurance that they are working in a conducive and quality-focused center. In mental health care, the agency plays a critical role in reviewing, appraising, and monitoring the performance standards of psychiatric and rehabilitation centers.

Centers for Medicare and Medicaid Services

CMS is a state-operating controlling body under the U.S division dealing with healthcare and human services. The agency has authority over the provision of core federal medical initiatives like Medicare, Medicaid, and children’s insurance programs. CMS is directly involved in the collection and analysis of data and the development of study reports regarding federal insurance covers. Again, eliminating incidences of fraudulent activities and abuse within state healthcare systems is another core task of the agency. By enhancing the number of adults and children having insurance covers, CMS enables patients to benefit APRNs’ theoretical and practical capabilities. CMS facilitates a vast number of mental or behavioral health patients to receive critical medical assistance through various insurance covers.

National Institutes of Health

The institution is the main governmental agency responsible for handling and supporting health-related research. Innovations, investigation, and discoveries influenced by the agency are critical in improving various areas of the medical practice and sector. The body is also responsible for investigating multiple therapy techniques or prevention measures. They also evaluate emerging disease causative factors and related effective treatments. APRNs can benefit significantly from the research and innovations by the agency; thus, gaining knowledge or technologies to improve service. Research is also essential in mental care as it can influence new cognitive-behavioral or pharmacotherapy approaches.

Health Regulatory Agencies


Level of Authority

Scope of Regulatory Authority


Relevance to APRN/DNP Graduate

Relevance to Specialty Area (Mental Health)

Center for Disease Control

National level

Primarily concentrates on preventing and responding to emerging infections.

Also comprises the following bodies:

a) Healthcare Infection Control Practices Advisory Committee

b) National Center for Preparedness, Detection, and Control of Infectious Diseases

The agency is responsible for monitoring ailments, birth defects, and genetics, monitors the health of travelers, enhances emergency preparedness and responses (Tappero et al., 2017).

The division also evaluates environmental health to identify probable risk factors.

Focuses on vaccinations and immunization

Advocates for suitable public health legislations (Tappero et al., 2017)

Carries out research to improve prevention against infections

An APRN can recognize the functions of the CDC, which helps in identifying a suitable approach in cases of emergencies that involve rare infections

The CDC can be significant in developing new treatments for unique psychotic conditions and behavioral conditions

Food and Drug Administration

National Level

Focuses on regulations regarding the safety of foods and drugs

Protects the public through the assurance of safety and efficiency of human and veterinary drugs and other biological product

It also monitors the safety of foods.

Enhances public health by supporting research and innovation that enhances the safety, affordability, and efficacy of foods and medicine

Standards set by the agency help APRNs comprehend the controlled drugs that they are legally permitted to prescribe or administer

The agency ensures that patients with mental ailments are not subjected to harmful pharmacotherapy drugs

United States Agency for Toxic Substances and Disease Registry

National Level

Offers regulation on the impacts of hazardous elements within public health spheres ((Holler, 2013).

Responsible for monitoring hazardous material

The division responds to threats regarding hazardous elements by monitoring compliance to standards and educating the public regarding HAZMAT risks (Holler, 2013).

Helps APRNs identify controlled substances that are safe for patients and the situations for prescribing or administering the substances

Mental health patients are administered various drugs that could be antidepressants, antipsychotics, mood stabilizers, and stimulants. Thus, the agency ensures that patients are not subjected to toxic substances.

Office of Health Care Quality

State Level

This is a division under health and mental hygiene, and it monitors care quality within Maryland

The agency is responsible for licensing and certifying Maryland’s medical facilities.

It also monitors adherence to the state and national regulations that underscore the standards of care.

Engages in research as a way of determining compliance in the state

Uses conferences, written documents, and online platforms to educate and create awareness regarding the relevance of complying with health care requirements

The division ensures that APRN has suitable practice licensure

The division ensures that counselors, psychotherapists, and psychiatrists have necessary licensure to carry out mental health treatment (Chaffee, 2015)

The Joint Commission

National and State Level

Accrediting medical institutions that deal with high-quality standards

Set and monitors adherence to performance standards for medical institutions (Jha, 2018).

Institution accreditation by the Joint Commission assures an APRN that he or she is working in a conducive institution

The Joint Commission accredits the performance of psychiatric and rehabilitation institutions (Chaffee, 2015)

Centers for Medicare and Medicaid Services

State Level

Provides and monitors insurance covers such as Medicare and Medicaid

It also monitors adherence to various acts such as the HIPAA and the Clinical Laboratory Improvement Amendments.

The division is responsible for developing criteria of participation and for insurance coverage that medical institutions must fulfill to participate within the federal insurance programs

The agency enhances the number of people covered by federal insurance, which means the APRN can serve a broad range of patients

The division guarantees medical cover to patients dealing with mental health conditions

National Institutes of Health

National and state-level

Conducts and supports healthcare research, which influences discoveries and improvement of healthcare

The institution also manages the National Institute of Allergy and Infectious Diseases

Engages in research to improve healthcare

Investigates different approaches to preventing diseases by identifying causative factors and practical treatments for common and rare conditions

The agency also offers leadership and funds research in the states

Research carried out by the institution is critical as APRN gain new knowledge or technologies to treat various conditions

Research supported by the agency enhances the treatment of patients with cognitive and behavioral conditions

References Chaffee, M. W. (2015). Policy & politics in nursing and health care (7 ed.). (D. J. Mason, D. B.Gardner, F. H. Outlaw, & E. T. O’Grady, Eds.) Elsevier Science Publishing Co. Holler, J. (2013). The emergency response program at the Agency for Toxic Substances and Disease Registry. Journal of Environmental Health, vol. 76, no. 3, pp. 46-47 Jha, A. K. (2018). Accreditation, quality, and making hospital care better. Jama, vol. 320, no. 23, pp. 2410-2411. Tappero, J. W., et al. (2017). US Centers for Disease Control and Prevention and its partners’ contributions to global health security. Emerging Infectious Diseases, vol. 23, no. (Suppl 1), pp. S5-S14.

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