CHAPTER 7. Regulatory Agencies and Accreditation
Nancy Burden
OBJECTIVES
At the conclusion of this chapter, the reader will be able to:
1. List three activities of the Office of the Inspector General.
2. Give three examples of activities addressed by state nurse practice acts.
3. Name at least three agencies within the U.S. Department of Health and Human Services (HHS).
4. Describe the major components of Health Insurance Portability and Accountability Act (HIPAA) regulations.
5. Give five examples of issues administered or regulated by state or local agencies.
I. REGULATORY AND ACCREDITATION ISSUES OVERVIEW
A. Standards are the foundation from which the nurse develops and expands an individual and collective level of service.
1. Standards related to the care of the patient are created and promulgated primarily by professional societies and educational institutions.
2. Professional nursing and medical standards, however, must function within a larger collection of regulations, laws, and requirements.
B. Most laws and regulations exist to protect the
1. Public
2. Patients
3. Health care workers
4. Financial and economic issues
C. All levels of government—federal, state, and local—exert control over various areas of practice.
1. Participation in Medicare, Medicaid, and other federally funded programs is dependent on meeting numerous requirements.
2. Examples include the requirement to:
a. Provide translation service for non–English-speaking patients (Civil Rights Act)
b. Provide advance notice of financial responsibility to people covered by Medicare who may be accessing services that are not covered by the federal insurance plan (Centers for Medicare & Medicaid Services [CMS])
3. Accreditation is a voluntary decision.
4. Federal and private payers expect providers will be accredited by a national accrediting body.
II. PROFESSIONAL REGULATIONS
A. National Council of State Boards of Nursing
1. National Council of Licensure Examination for RN
2. National standard examination with single passing standard
B. Nursing boards and state nurse practice acts
1. Regulate professional nursing practice and licensing.
2. Identify scope of practice (e.g., administration of anesthetic agents for sedation/analgesia).
3. Protect autonomy of the professional nurse.
4. Protect public health.
a. Standards for safe nursing care
b. Issuing licenses
c. Monitoring licensed nurses’ compliance to state laws
d. Disciplinary actions for unsafe practice
5. Require that ethical and professional conduct standards be met, such as American Nurses Association’s Code for Nurses.
6. Regulations vary by state.
7. Some reciprocity of requirements from state to state but separate licensing
C. Certification boards—voluntary
1. Specialty specific
a. Certified Post Anesthesia Nurse
b. Certified Ambulatory PeriAnesthesia Nurse
c. Certified Nurse Operating Room
d. Certified Gastroenterology Registered Nurse
e. Registered Nurse—Board Certified in Pain Management
f. Certified Administrator Surgery Center
2. Testing function separate from educational entity of professional organization
3. Promotes high level of education, experience, and application
4. Demonstrates to public and peers commitment to professional excellence
D. Other health care providers with professional regulation
1. Physicians
2. Nurse anesthetists
3. Advanced registered nurse practitioners
4. Physician assistants
5. Radiology technologists
6. Pharmacists
III. FACILITY-SPECIFIC REGULATIONS
A. Policies and procedures (e.g., human resources, clinical, administrative)
1. Identify methods and reasons to perform in a specific manner.
2. Apply consistently and fairly.
3. Ensure that practice conforms to policies.
B. Emergency management plans and policies
C. Employment requirements and job descriptions
D. Patient and employee rights and responsibilities
E. Drug-free/smoke-free workplace regulations
IV. COUNTY AND LOCAL REGULATIONS
A. Business licensing
B. Fire and disaster plans
C. Emergency management plans
D. Building codes and permits
E. Impact fees
F. Environmental regulations
V. STATE REGULATIONS
A. Laws and statutes vary by state.
B. Often define and/or enforce federal mandates
C. Examples
1. Facility licensing: hospitals, ambulatory surgery centers, pharmacies
2. Professional licensing
3. Risk management laws
4. Insurance coverage requirements
5. Biohazardous waste handling
6. Pharmacy licensing and regulation
7. Public health laws
8. Radiation control
9. Health statistics reporting
10. Child, adult, elder abuse reporting
VI. FEDERAL REGULATIONS, STANDARDS, AND GUIDELINES
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A. U.S. Department of HHS
1. Far-reaching regulatory control, umbrella department for many agencies
2. CMS
3. Fraud prevention and reporting
4. Freedom of Information Act
5. Biologicals (blood, organs, tissues)
6. Poverty guidelines
7. National Practitioner Data Bank (NPDB)
8. Agency for Healthcare Research and Quality (AHRQ)
9. Food and Drug Administration (FDA)
10. Centers for Disease Control and Prevention (CDC)
B. Americans With Disabilities Act, 1990
1. Administered by Department of Justice, Civil Rights Division
2. Protects against discrimination based on disabilities
3. Applies to prospective and current employees and workplace issues, as well as to the public’s access to facilities and services
4. Removes barriers to access—physical, process, and attitudinal
5. Reasonable modification of policies, practices, and procedures to accommodate
6. Auxiliary aids such as qualified interpreters, telecommunications devices for the deaf, large print materials
a. Interpreters should have medical terminology skills.
b. Do not use family members.
c. Cannot pass along cost of interpreter to patients
7. Sets hiring and interviewing guidelines
8. Expects reasonable accommodation for otherwise qualified candidates
C. CDC
1. Component of the Department of HHS
2. Mission: to promote health and quality of life by preventing and controlling disease, injury, and disability
a. Monitors health
b. Detects and investigates health problems
c. Conducts research to enhance prevention
d. Develops and advocates sound public health policies
e. Implements prevention strategies
f. Promotes healthy behaviors
g. Fosters safe and healthful environments
h. Provides leadership and training
3. Recommends disease prevention strategies affecting health care workers
a. Hand washing standards
b. Tuberculosis screening for health care workers
c. Immunization against hepatitis
4. Guideline for hand hygiene in health care settings
5. Provides accurate health care information
6. Investigates disease outbreaks
D. Civil Rights Acts of 1957, 1960, 1964, 1968, 1973, 1980
1. Administered by Department of Justice, Civil Rights Division
2. Ten program-related sections
3. Antidiscrimination statutes, broader than only health care
4. Prohibit discrimination on basis of national origin, race, age, gender, and other factors
5. Develop comprehensive language assistance program
a. Assess facility’s language needs
b. Develop formal written policy
c. Train staff
d. Monitor program continually
E. Clinical Laboratory Improvement Amendments (CLIA) Program
1. CMS regulates all laboratory testing to ensure quality.
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