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Questions and Answers
What major legislation altered the deferral to state regulation of insurers in 1996?
What major legislation altered the deferral to state regulation of insurers in 1996?
Which of the following programs was created with the amendment of the Social Security Act in 1965?
Which of the following programs was created with the amendment of the Social Security Act in 1965?
What types of entities are classified as 'providers' under the Medicare terminology?
What types of entities are classified as 'providers' under the Medicare terminology?
What do HMO Model Acts primarily address?
What do HMO Model Acts primarily address?
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The federal role in establishing quality standards for healthcare includes oversight of which programs?
The federal role in establishing quality standards for healthcare includes oversight of which programs?
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What are Conditions of Participation (CoP) in the context of Medicare?
What are Conditions of Participation (CoP) in the context of Medicare?
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What term is used to refer to agencies that provide diagnosis and therapy rather than sustained patient care in Medicare terminology?
What term is used to refer to agencies that provide diagnosis and therapy rather than sustained patient care in Medicare terminology?
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What is the primary mission of the Substance Abuse and Mental Health Services Administration (SAMHSA)?
What is the primary mission of the Substance Abuse and Mental Health Services Administration (SAMHSA)?
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Under which circumstances is a self-insured plan regulated solely by the federal government?
Under which circumstances is a self-insured plan regulated solely by the federal government?
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What federal act left states responsible for regulating the business of insurance?
What federal act left states responsible for regulating the business of insurance?
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What characterizes managed care as a system?
What characterizes managed care as a system?
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Which of the following statements is true about the relationship between state and federal regulations of managed care organizations (MCOs)?
Which of the following statements is true about the relationship between state and federal regulations of managed care organizations (MCOs)?
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Which act established federal standards specifically for health maintenance organizations (HMOs)?
Which act established federal standards specifically for health maintenance organizations (HMOs)?
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What is a challenge faced by healthcare quality professionals working with health plans?
What is a challenge faced by healthcare quality professionals working with health plans?
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Which of the following describes the role of the federal government regarding managed care?
Which of the following describes the role of the federal government regarding managed care?
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What happens to a healthcare organization certified as noncompliant with CMS?
What happens to a healthcare organization certified as noncompliant with CMS?
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What was the primary purpose of establishing the National Practitioner Data Bank (NPDB)?
What was the primary purpose of establishing the National Practitioner Data Bank (NPDB)?
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What key legislation led to the creation of the Healthcare Integrity and Protection Data Bank (HIPDB)?
What key legislation led to the creation of the Healthcare Integrity and Protection Data Bank (HIPDB)?
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What was the outcome of the merger between NPDB and HIPDB in 2013?
What was the outcome of the merger between NPDB and HIPDB in 2013?
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What authority does the HHS Office of Inspector General have concerning NPDB?
What authority does the HHS Office of Inspector General have concerning NPDB?
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Which change to the NPDB occurred as a result of the ACA's Section 6403?
Which change to the NPDB occurred as a result of the ACA's Section 6403?
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What additional information does NPDB track concerning healthcare practitioners?
What additional information does NPDB track concerning healthcare practitioners?
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What amendment did Congress make to the NPDB law in 1990?
What amendment did Congress make to the NPDB law in 1990?
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What does accreditation primarily signify in the healthcare sector?
What does accreditation primarily signify in the healthcare sector?
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Which of the following best describes certification?
Which of the following best describes certification?
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In what way does certification differ from accreditation?
In what way does certification differ from accreditation?
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What aspect do recognition programs most significantly influence?
What aspect do recognition programs most significantly influence?
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What is required for a clinical laboratory to receive Medicare or Medicaid payments?
What is required for a clinical laboratory to receive Medicare or Medicaid payments?
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Which statement about the NCQA Recognition Program is accurate?
Which statement about the NCQA Recognition Program is accurate?
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Which federal certification requirement mandates that all mammography facilities must be certified?
Which federal certification requirement mandates that all mammography facilities must be certified?
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What is the purpose of CLIA in the context of healthcare certification?
What is the purpose of CLIA in the context of healthcare certification?
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What is the purpose of EMTALA in the healthcare system?
What is the purpose of EMTALA in the healthcare system?
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How many discrete regulatory requirements must healthcare providers comply with according to the American Hospital Association?
How many discrete regulatory requirements must healthcare providers comply with according to the American Hospital Association?
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What percentage of full-time employees in an average size hospital is dedicated to regulatory compliance activities?
What percentage of full-time employees in an average size hospital is dedicated to regulatory compliance activities?
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Which domain is NOT one of the nine domains of regulatory requirements for healthcare organizations?
Which domain is NOT one of the nine domains of regulatory requirements for healthcare organizations?
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Which of the following is a challenge faced by healthcare quality professionals in relation to regulations?
Which of the following is a challenge faced by healthcare quality professionals in relation to regulations?
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What is one of the foundational federal laws affecting healthcare organizations mentioned?
What is one of the foundational federal laws affecting healthcare organizations mentioned?
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Which of the following describes a consequence of the complex regulatory landscape for healthcare organizations?
Which of the following describes a consequence of the complex regulatory landscape for healthcare organizations?
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What is the primary responsibility of the Food & Drug Administration (FDA)?
What is the primary responsibility of the Food & Drug Administration (FDA)?
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Which organization is responsible for offering federal health services to American Indians and Alaska Natives?
Which organization is responsible for offering federal health services to American Indians and Alaska Natives?
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Which of the following is NOT a role of the National Institutes of Health (NIH)?
Which of the following is NOT a role of the National Institutes of Health (NIH)?
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What is a major focus of the Office of Inspector General (OIG)?
What is a major focus of the Office of Inspector General (OIG)?
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Which federal law is associated primarily with preventing physician self-referrals?
Which federal law is associated primarily with preventing physician self-referrals?
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Which of the following best describes the role of the Health Resources & Services Administration (HRSA)?
Which of the following best describes the role of the Health Resources & Services Administration (HRSA)?
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What is one of the significant roles played by the FDA apart from ensuring drug safety?
What is one of the significant roles played by the FDA apart from ensuring drug safety?
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Which of the following categories does NOT fall under the jurisdiction of the FDA?
Which of the following categories does NOT fall under the jurisdiction of the FDA?
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The Administration for Community Living (ACL) was founded in 2010.
The Administration for Community Living (ACL) was founded in 2010.
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The Agency for Healthcare Research and Quality (AHRQ) focuses on healthcare safety, quality, accessibility, equity, and affordability.
The Agency for Healthcare Research and Quality (AHRQ) focuses on healthcare safety, quality, accessibility, equity, and affordability.
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The Centers for Medicare & Medicaid Services (CMS) oversee only the federal portion of the Medicare program.
The Centers for Medicare & Medicaid Services (CMS) oversee only the federal portion of the Medicare program.
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The Agency for Toxic Substances and Disease Registry (ATSDR) works to enhance exposure to environmental pollution.
The Agency for Toxic Substances and Disease Registry (ATSDR) works to enhance exposure to environmental pollution.
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The Centers for Disease Control and Prevention (CDC) operates 24/7 to protect public health.
The Centers for Disease Control and Prevention (CDC) operates 24/7 to protect public health.
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The Administration for Children & Families (ACF) operates independently without partnerships with states and community organizations.
The Administration for Children & Families (ACF) operates independently without partnerships with states and community organizations.
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The Centers for Disease Control and Prevention (CDC) address both chronic and acute diseases.
The Centers for Disease Control and Prevention (CDC) address both chronic and acute diseases.
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The Administration for Aging is a component of the Administration for Community Living (ACL).
The Administration for Aging is a component of the Administration for Community Living (ACL).
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General acute care hospitals and medical homes are subject to the same regulatory requirements.
General acute care hospitals and medical homes are subject to the same regulatory requirements.
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EMTALA was enacted to prevent hospitals from transferring insured patients to public hospitals without a medical screening examination.
EMTALA was enacted to prevent hospitals from transferring insured patients to public hospitals without a medical screening examination.
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Healthcare providers spend approximately $39 billion annually on administrative activities related to regulatory compliance.
Healthcare providers spend approximately $39 billion annually on administrative activities related to regulatory compliance.
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Health systems must comply with 629 regulatory requirements that are categorized across eight domains.
Health systems must comply with 629 regulatory requirements that are categorized across eight domains.
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Private organizations that serve as quasi-regulators in healthcare are primarily government entities.
Private organizations that serve as quasi-regulators in healthcare are primarily government entities.
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Healthcare quality professionals do not need to research and interpret regulations that pertain to new services offered by their organizations.
Healthcare quality professionals do not need to research and interpret regulations that pertain to new services offered by their organizations.
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The American Medical Association (AMA) only provides guidelines for medical practice without any regulatory oversight.
The American Medical Association (AMA) only provides guidelines for medical practice without any regulatory oversight.
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The Emergency Medical Treatment and Active Labor Act (EMTALA) is often referred to as the 'anti-dumping' law.
The Emergency Medical Treatment and Active Labor Act (EMTALA) is often referred to as the 'anti-dumping' law.
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States are required to report their regulatory actions to accrediting bodies and the Center for Medicare & Medicaid Services (CMS).
States are required to report their regulatory actions to accrediting bodies and the Center for Medicare & Medicaid Services (CMS).
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Healthcare quality professionals spend most of their time responding to regulatory compliance instead of improving patient care.
Healthcare quality professionals spend most of their time responding to regulatory compliance instead of improving patient care.
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Healthcare quality professionals are discouraged from becoming familiar with state healthcare regulations.
Healthcare quality professionals are discouraged from becoming familiar with state healthcare regulations.
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The regulatory landscape in healthcare is static and does not frequently change.
The regulatory landscape in healthcare is static and does not frequently change.
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Organizations that fail to comply with state regulations may face penalties such as loss of licensure and inability to provide healthcare services.
Organizations that fail to comply with state regulations may face penalties such as loss of licensure and inability to provide healthcare services.
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Accreditation and certification are terms that have no significant application within the healthcare industry.
Accreditation and certification are terms that have no significant application within the healthcare industry.
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State medical boards often utilize privately administered examinations for granting medical licenses.
State medical boards often utilize privately administered examinations for granting medical licenses.
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A continuous compliance strategy is unnecessary for alignment with federal and state regulations.
A continuous compliance strategy is unnecessary for alignment with federal and state regulations.
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The Federal Register is updated annually.
The Federal Register is updated annually.
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Healthcare quality professionals are discouraged from using the Internet for federal regulation updates.
Healthcare quality professionals are discouraged from using the Internet for federal regulation updates.
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The Unified Agenda of Regulatory and Deregulatory Actions is published biannually.
The Unified Agenda of Regulatory and Deregulatory Actions is published biannually.
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Negative actions against healthcare practitioners must be reported by government peer-review organizations only.
Negative actions against healthcare practitioners must be reported by government peer-review organizations only.
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Revocation of a professional society membership is not considered an adverse action.
Revocation of a professional society membership is not considered an adverse action.
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The HHS plan outlines only the legal basis for regulatory priorities.
The HHS plan outlines only the legal basis for regulatory priorities.
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The Code of Federal Regulations (CFR) is updated only once every two years.
The Code of Federal Regulations (CFR) is updated only once every two years.
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Licensing boards are responsible for disciplining healthcare professionals for unprofessional behavior.
Licensing boards are responsible for disciplining healthcare professionals for unprofessional behavior.
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The Cures Act aims to enhance interoperability by making electronic health information exchange easier without special effort from users.
The Cures Act aims to enhance interoperability by making electronic health information exchange easier without special effort from users.
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The U.S. Department of Health & Human Services (HHS) operates solely through federal agencies and does not collaborate with state or local governments.
The U.S. Department of Health & Human Services (HHS) operates solely through federal agencies and does not collaborate with state or local governments.
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The primary goal of HHS's office is to provide leadership and policy guidance to the Department.
The primary goal of HHS's office is to provide leadership and policy guidance to the Department.
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The definition of information blocking is that it includes the exchange of electronic health information with significant effort required from the user.
The definition of information blocking is that it includes the exchange of electronic health information with significant effort required from the user.
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HHS has 11 operating divisions, all of which offer health and human services to individuals, families, and communities.
HHS has 11 operating divisions, all of which offer health and human services to individuals, families, and communities.
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Interoperability as defined by the Cures Act does not impact the privacy and security aspects of health information technology.
Interoperability as defined by the Cures Act does not impact the privacy and security aspects of health information technology.
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One of HHS's missions involves conducting life-saving research and providing effective public health services.
One of HHS's missions involves conducting life-saving research and providing effective public health services.
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The Cures Act specifically prohibits unauthorized access to mental health services information without user consent.
The Cures Act specifically prohibits unauthorized access to mental health services information without user consent.
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Accreditation is primarily concerned with recognizing the competency of individuals in healthcare.
Accreditation is primarily concerned with recognizing the competency of individuals in healthcare.
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Certification can only be granted by government agencies.
Certification can only be granted by government agencies.
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The National Committee for Quality Assurance (NCQA) recognizes programs to enhance informed healthcare decision-making.
The National Committee for Quality Assurance (NCQA) recognizes programs to enhance informed healthcare decision-making.
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The Mammography Quality Standards Act (MQSA) allows any facility providing mammography to operate without certification.
The Mammography Quality Standards Act (MQSA) allows any facility providing mammography to operate without certification.
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Federally certified clinical laboratories are exempt from Medicare or Medicaid payment requirements.
Federally certified clinical laboratories are exempt from Medicare or Medicaid payment requirements.
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Accrediting organizations must meet CMS requirements, but their inspections can substitute for CMS's own inspections.
Accrediting organizations must meet CMS requirements, but their inspections can substitute for CMS's own inspections.
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Recognition programs in healthcare help standardize practices only for individual clinicians.
Recognition programs in healthcare help standardize practices only for individual clinicians.
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Accreditation and certification are terms that can be used interchangeably in healthcare.
Accreditation and certification are terms that can be used interchangeably in healthcare.
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Match the following accreditation organizations with their primary focus:
Match the following accreditation organizations with their primary focus:
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Match the following regulatory bodies with their main responsibilities:
Match the following regulatory bodies with their main responsibilities:
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Match the following terms with their definitions:
Match the following terms with their definitions:
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Match the following federal laws with their objectives:
Match the following federal laws with their objectives:
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Match the following types of regulations with their sources:
Match the following types of regulations with their sources:
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Match the following performance measures with their purposes:
Match the following performance measures with their purposes:
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Match the following continuous readiness components with their focus areas:
Match the following continuous readiness components with their focus areas:
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Match the following concepts related to organizational learning with their benefits:
Match the following concepts related to organizational learning with their benefits:
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Match the following acts with their primary focus:
Match the following acts with their primary focus:
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Match the following dates with their corresponding acts:
Match the following dates with their corresponding acts:
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Match the components with their descriptions:
Match the components with their descriptions:
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Match the key terms with their definitions:
Match the key terms with their definitions:
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Match the acts with their legal implications:
Match the acts with their legal implications:
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Match the following healthcare terms with their meanings:
Match the following healthcare terms with their meanings:
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Match the legislation timeline with the corresponding events:
Match the legislation timeline with the corresponding events:
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Match the federal acts to their main goals:
Match the federal acts to their main goals:
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Match the following key terms related to managed care with their corresponding descriptions:
Match the following key terms related to managed care with their corresponding descriptions:
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Match the following federal acts with their primary focus or contribution:
Match the following federal acts with their primary focus or contribution:
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Match the following entities with their role in healthcare regulation:
Match the following entities with their role in healthcare regulation:
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Match the following organizations with their target populations or functions:
Match the following organizations with their target populations or functions:
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Match the following healthcare regulations with their respective scopes:
Match the following healthcare regulations with their respective scopes:
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Match the following definitions related to healthcare quality with their correct terms:
Match the following definitions related to healthcare quality with their correct terms:
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Match the following healthcare organizations with their characteristics:
Match the following healthcare organizations with their characteristics:
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Match the agencies responsible for healthcare regulation with their functions:
Match the agencies responsible for healthcare regulation with their functions:
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Match the following challenges faced by healthcare professionals with their corresponding contexts:
Match the following challenges faced by healthcare professionals with their corresponding contexts:
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Match the following Medicare conditions or regulations with their focus area:
Match the following Medicare conditions or regulations with their focus area:
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Match the following terms related to healthcare reform with their implications:
Match the following terms related to healthcare reform with their implications:
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Match the terms regarding healthcare quality oversight with their descriptions:
Match the terms regarding healthcare quality oversight with their descriptions:
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Match the following conditions with their corresponding requirements:
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Match the organization with its primary responsibility:
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Match the organization with its established year or notable beginning:
Match the organization with its established year or notable beginning:
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Match the following healthcare certification terms with their processes:
Match the following healthcare certification terms with their processes:
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Match the following statements about state and federal healthcare roles:
Match the following statements about state and federal healthcare roles:
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Match the organization with a specific law it is associated with:
Match the organization with a specific law it is associated with:
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Match the following programs or acts with their focus areas:
Match the following programs or acts with their focus areas:
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Match the organization with its role in healthcare:
Match the organization with its role in healthcare:
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Match the organization with their target population:
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Match the organization with the type of healthcare they focus on:
Match the organization with the type of healthcare they focus on:
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Match the organization with its key funding or support mechanism:
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Match the organization with their initiative related to public health threats:
Match the organization with their initiative related to public health threats:
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Match the following regulatory terms with their definitions:
Match the following regulatory terms with their definitions:
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Match the following organizations with their roles in the healthcare regulatory framework:
Match the following organizations with their roles in the healthcare regulatory framework:
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Match the following state actions with their potential outcomes:
Match the following state actions with their potential outcomes:
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Match the following elements of the healthcare quality framework with their descriptions:
Match the following elements of the healthcare quality framework with their descriptions:
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Match the following healthcare compliance strategies with their characteristics:
Match the following healthcare compliance strategies with their characteristics:
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Match the following healthcare terms with their principal aspects:
Match the following healthcare terms with their principal aspects:
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Match the following healthcare entities with their monitoring functions:
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Match the following types of regulatory activities with their descriptions:
Match the following types of regulatory activities with their descriptions:
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Study Notes
Section 3: Regulatory and Accreditation
- Regulatory compliance is crucial for healthcare organizations
- Quality professionals advise on complex regulatory requirements
- This section covers local and national statutory and regulatory necessities
- Process development and evaluation for compliance with federal and state requirements is included
- Survey/accreditation readiness is also addressed
- Legal aspects include federal laws (Acts and regulations) vs. state-specific laws; quasi-regulatory roles are differentiated from federal/state regulatory bodies
- The dynamic nature of healthcare laws, regulations, and accreditation/certification standards is highlighted
- Importance of maintaining structures and dedicated resources to ensure ongoing compliance is emphasized.
- Surveyors may include federal (CMS), state, or accreditation agencies
- State and local agencies review healthcare entities for Medicare compliance.
- Accreditation typically involves meeting more rigorous standards than minimum licensure requirements.
- Organizations should use tools to prepare for surveys and regularly evaluate their compliance.
Introduction
- Compliance with laws, regulations, and accreditation standards is vital for healthcare organizations' success.
- Healthcare quality professionals play a pivotal role in advising on requirements, leading to consistent compliance.
- This section outlines the steps to become aware of and comply with state and federal standards, and process development and evaluation, including a dynamic approach for continuous improvements
Laws and Regulations
- Federal Laws: Passed by Congress and signed by the President. Arranged by subject in the United States Code.
- Federal Regulations: Rules issued by executive departments/agencies, organized in the Code of Federal Regulations (CFR).
- State-Specific Laws: Healthcare practices governed by state-level regulations which often supersede federal laws if more stringent. These frequently include licensure, medical records, required coverage, and more.
- Quasi-Regulatory Roles: Accreditation agencies, such as The Joint Commission (TJC), are recognized as quasi-regulatory bodies with standards considered superior to minimum licensure requirements.
- Agencies publish guidelines and guidance documents available to the public, often online.
Federal Agencies
- U.S. Department of Health & Human Services (HHS) is a large and influential agency directly relating to healthcare.
- Numerous agencies under HHS manage different aspects of health and human services, including: Centers for Medicare & Medicaid Services (CMS), The Agency for Healthcare Research and Quality (AHRQ), and the Centers for Disease Control and Prevention (CDC), Food & Drug Administration (FDA), Health Resources & Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), Office of Inspector General (OIG), Substance Abuse and Mental Health Services Administration (SAMHSA).
Federal Laws and Regulations
- EMTALA (Emergency Medical Treatment and Active Labor Act) : Prevents hospitals from transferring patients without a medical assessment/emergency treatment; this is important public protection.
- CLIA (Clinical Laboratory Improvement Amendments) : Sets quality standards for laboratories for accurate, timely, and reliable test results, and compliance includes different testing complexities.
- HIPAA (Health Insurance Portability and Accountability Act) : Protects patient health information from unauthorized disclosure, with specific rules around who can access protected health information.
- PPACA (Patient Protection and Affordable Care Act): Comprehensive U.S. health insurance reforms. Includes new programs and value-based payment models to increase healthcare quality and efficiency, which significantly impact healthcare delivery.
- HITECH Act: Enhances the use of health information technology, with an emphasis on interoperability and privacy/security; it's crucial for today's healthcare settings
Accreditation, Certification, and Recognition
- Both involve meeting established standards.
- Accreditation: Official authorization/approval by private organizations; frequently required for payer program participation and is a form of validated proof of adherence to regulatory rules or standards.
- Certification: Recognition of meeting standards within a specific field; issued by private organizations or government agencies. It may include demonstration of compliance or meeting requirements.
- Accreditation is used to demonstrate organizations' compliance with specific standards, often with regulatory requirements attached.
Various Agencies
- Numerous organizations offer accreditation and other validation services, many with specific programs and procedures (e.g. AAAHC, ACHC, ACS, CARF, CHAP)
Federal Resources
- Federal government resources provide information on regulations and standards.
- Websites offer up-to-date and publicly accessible resources; these include the Federal Register, Code of Federal Regulations (CFR), and agency-specific websites.
- Agencies often publish guidelines, guidance documents, and FAQs for public access to regulations.
Continuous Survey Readiness
- Encompasses organizational preparedness for external audits or inspections.
- Leaders must ensure consistent compliance, not just for survey periods, but continuously.
- Self-assessment remains integral to the continuous survey readiness process; this includes an ongoing, proactive approach to address identified deficits and potential ones by continuously monitoring and reviewing requirements.
- Using tools and strategies (such as checklists, work plans, and tracers) helps streamline processes and prepare for surveys.
- Survey readiness involves organizational preparedness, leadership commitment, management accountability, and ongoing compliance oversight.
- Organizations should be aware of relevant changes in regulations and standards and develop a system for tracking and addressing these changes to maintain their continuous compliance status.
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Description
This quiz explores the critical aspects of regulatory compliance and accreditation in healthcare organizations. It covers the roles of quality professionals, the importance of understanding both federal and state laws, and the dynamic nature of healthcare regulations. Prepare to assess your knowledge on maintaining compliance and readiness for accreditation.