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
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.
2. Labs must be certified to receive Medicare or Medicaid reimbursement.
3. CLIA waivers for specific point-of-care testing apparatus
a. Competency requirements
b. Required controls for test equipment
F. CMS (formerly Health Care Financing Administration)
1. Medicare and Medicaid
a. Payment and coordination of health care benefits
b. Fraud and abuse prevention and reporting
c. False Claims Act (protects and rewards whistleblowers who report fraudulent claims against federal government)
d. Anti-kickback statutes
2. State Children’s Health Insurance Program
3. Health Insurance Portability and Accountability Act of 1996 (HIPAA of 1996)
4. CLIA
G. Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1986
1. Applies to certain former employees, spouses, dependent children, retirees
2. Right to temporary continuation of health insurance coverage at group rates upon loss of employment
H. U.S. Drug Enforcement Administration
1. Controlled Substances Act, Title II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970
a. Categorizes drugs regulated under federal laws into five schedules based upon the substance’s medicinal value, harmfulness, and potential for abuse or addiction
(1) Schedule I: highest (heroin, lysergic acid diethylamide [LSD], hashish
(2) Schedule II: high (morphine, phencyclidine (PCP), codeine, cocaine, methadone, meperidine, Benzedrine, etc.)
(3) Schedule III: medium (codeine with aspirin or Tylenol, anabolic steroids, etc.)
(4) Low (Darvon, Talwin, phenobarbital, Equanil, Librium, diazepam, etc.)
(5) Lowest (over-the-counter or prescription compounds with codeine, Lomotil, Robitussin-AC, etc.)
b. System of distribution for those authorized to handle controlled substances
c. Registration of those authorized to handle controlled substances
d. Documentation and inventory control requirements
e. Storage security regulations
f. Periodic inspections
2. Works in conjunction with U.S. Department of HHS
I. Emergency Medical Treatment and Active Labor Act
1. Part of COBRA of 1986
2. Regulations passed in 1998
3. Part of code that governs Medicare (Section 1867[a] of the Social Security Act)
4. Applies only to “participating hospitals,” those that are providers for CMS beneficiaries
5. Primary purpose: to prevent hospitals from rejecting, refusing to treat, or transferring patients to “charity hospitals” or “county hospitals” because they are unable to pay or are covered under the Medicare or Medicaid programs
6. Hospitals must provide stabilizing treatment for emergency medical conditions.
J. Employee Retirement Income Security Act
1. To ensure pension and other promised benefits
2. Connected to Internal Revenue Code
K. Fair Labor Standards Act
1. Also known as Wage and Hour Regulations
2. Defines exempt and nonexempt requirements for overtime
3. Clarifies how pay issues are to be communicated
4. Sets guidelines for age-appropriate work and hours
L. HIPAA of 1996
1. Title I: protects health insurance for workers who change or lose their jobs
2. Title II: Administrative Simplification Standards
a. Electronic health transactions
b. Unique identifiers
c. Security and electronic signature
d. Privacy and confidentiality
3. Congress added Administrative Simplification Standards section to standardize code sets, formats, and identifiers to save money.
4. Protected health information (PHI)
5. Privacy Rule: empowers patients and gives them more control over their PHI, how it is used, where it is shared
6. Three areas where PHI can be shared freely, albeit confidentially
a. T—Treatment
b. P—Payment
c. O—Operations
7. Provides for civil and criminal penalties for noncompliance
M. Patient Self-Determination Act
1. Advance directives
a. Living will
b. Durable power of attorney
2. Facility must have written policies and procedures that meet requirements for advance directives.
3. Written information for patients—requirements vary by type of medical facility
4. Educate staff on advance directive policies and requirements.
N. NPDB
1. Under HHS, Bureau of Health Professionals
2. Created to improve quality of health care by:
a. Encouraging agencies and state licensing boards to identify and discipline those engaging in unprofessional behavior
b. Restricting ability for those practitioners to move from state to state
3. Requiring reporting by health care facilities
4. Using databank for credentialing and recredentialing licensed independent practitioners
5. Access to information restricted to entities that meet eligibility requirements
VII. OFFICE OF THE INSPECTOR GENERAL (OIG)
A. Work authorized by the Inspector General Act of 1978
B. Independent units within federal departments to:
1. Conduct audits and investigate programs and operations
2. Coordinate and recommend policies to promote economy, efficiency, and effectiveness
3. Prevent and detect fraud and abuse
4. Keep authorities informed about need for corrective action
C. Work Plan: developed annually to identify areas most worthy of attention by the OIG
VIII. FEDERAL AGENCIES AND OTHER ORGANIZATIONS ADDRESSING QUALITY AND SAFETY
A. AHRQ
1. Arm of Department of HHS
2. Federal agency for research on health care quality, costs, outcomes, and patient safety
3. Research goals
a. Identify most effective ways to organize, manage, finance, and deliver high-quality care.
b. Reduce medical errors.
c. Improve patient safety.
4. Supports improvements in health outcomes
5. Develops strategies to strengthen quality measurement and improvement
6. Identifies strategies to improve health care access, fosters appropriate use, and reduces unnecessary expenditures
B. Medical device reporting
1. U.S. FDA
2. Safe Medical Devices Act of 1990, 1997, 2000
3. Objective: provide mechanism to identify and monitor significant adverse events related to medical devices
4. Responsibilities by manufacturers and device users (medical facilities)
5. MedWatch Program is mandatory reporting mechanism.
6. Deaths or serious injuries must be reported within 10 workdays.
7. Center for Devices and Radiological Health
C. National Fire Protection Association
1. International nonprofit organization
2. Mission: to reduce the worldwide burden of fire and other hazards on the quality of life by providing and advocating consensus codes and standards, research, training, and education
3. Develops, publishes, and disseminates timely consensus codes and standards intended to minimize the possibility and effects of fire and other risks
4. Standards referenced by agencies and regulator bodies for compliance
D. Occupational Safety and Health Administration
1. Division of the U.S. Department of Labor
2. Williams-Steiger Occupational Safety and Health Act of 1970
3. Protection of workers. Examples:
a. Environmental safety standards (e.g., fire safety, escape routes)
b. Ergonomic controls
c. Hazard communication standard (e.g., material safety data sheets)
d. Materials handling and storage hazards and controls
e. Needlestick Safety and Prevention Act
4. Exposure control plan
a. Occupational exposure to bloodborne pathogens—Standard 29 CFR 1910.1030
b. Determine employee exposure risk.
c. Outline methods to control exposure.
d. Use engineering controls and work safety practices to improve safety (e.g., needleless systems, one-hand techniques).
e. Provide personal protective equipment.
f. Housekeeping, laundry practices
g. Hepatitis B vaccination program
h. Evaluate exposures.
i. Documentation
5. Workplace inspection priorities
a. Imminent danger
b. Fatal accidents
c. Employee complaint
d. Referral by other government agency
e. Employer with high accident rate
f. Follow-up
E. Surgical Care Improvement Project (SCIP)
1. National quality partnership of 36 organizations, companies, and agencies
2. Seeking continued hospital involvement
3. Goal to reduce the incidence of surgical complications nationally by 25% by the year 2010
4. Focus areas
a. Cardiac
b. Infections
c. Respiratory
d. Venous thromboembolism
e. End-stage renal disease
5. Surgical site infections
a. Responsible for 14% to 16% of all hospital-acquired infections
b. Cost for each patient developing an infection: $3152 and up to 7 days of hospitalization
c. Manage glucose levels.
d. Avoid shaving skin preoperatively.
e. Proper type and timing of preoperative antibiotics
f. Proper perioperative thermoregulation
F. Institute for Healthcare Improvement
1. Protecting 5 Million Lives From Harm campaign
2. Some is not a number. Soon is not a time.
3. Voluntary initiative to protect 5 million people from medical harm between December 2006 and December 2008
4. Carried over from 100,000 Lives campaign
a. Deploy rapid response teams.
b. Deliver reliable, evidence-based care for acute myocardial infarction.
c. Prevent adverse drug events by implementing medication reconciliation.
d. Prevent central line infections.
e. Prevent surgical site infections by reliably delivering the correct perioperative antibiotics at the proper time.
f. Prevent ventilator-associated pneumonia.
5. Additional interventions
a. Prevent harm from high alert medications … starting with a focus on anticoagulants, sedatives, narcotics, and insulin.
b. Reduce surgical complications by reliably implementing all the changes in care recommended by SCIP.
c. Prevent pressure ulcers.
d. Reduce methicillin-resistant Staphylococcus aureus infection.
e. Deliver reliable, evidence-based care for congestive heart failure.
f. Get boards on board.
IX. WORLD HEALTH ORGANIZATION (WHO)
A. World Alliance for Patient Safety
B. WHO Guidelines on Hand Hygiene in Health Care (Advanced Draft): A Summary
1. Indications for hand washing
2. Hand hygiene technique
3. Surgical hand preparation
4. Selection of agents
5. Skin care
6. Glove use
7. Other aspects of hand hygiene
8. Health care worker training
9. Government and institutional responsibilities
C. Benefits of improved hand hygiene
X. ACCREDITING AGENCIES: VOLUNTARY OPTIONS
A. Joint Commission
1. Acute care, ambulatory, long-term care and other types of health care programs
2. Recognized by third-party payers and government agencies
3. Surveys are unannounced
4. Strong emphasis on safety initiatives
5. Publishes National Patient Safety Goals and Sentinel Event Alerts
B. Accreditation Association for Ambulatory Health Care, Inc.
1. Surveys many types of ambulatory health care providers
2. Emphasizes constructive consultation and education
3. Recognized by third-party payers and government agencies
C. American Association for Accreditation of Ambulatory Surgery Facilities
1. To ensure high standards in office-based surgery
2. Single specialty and multispecialty facilities owned and operated by surgeons who are certified by a board recognized by the American Board of Medical Specialties
3. Requires peer review and quality and process improvement programs to be in place
BIBLIOGRAPHY
1. Accreditation Association for Ambulatory Health Care, Inc, Available at:www.aaahc.org; Accessed November 21, 2008.
2. Agency for Healthcare Research and Quality, Available at:www.ahrq.org; Accessed November 20, 2008.
3. American Association for Accreditation of Ambulatory Surgery Facilities, Available at:www.aaaasf.org; Accessed November 21, 2008.
4. Boyce, J.; Pittet, D., Guideline for hand hygiene in health-care settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPA/SHEA/APIC/IDSA Hand Hygiene Task Force, Infect Control Hosp Epidemiol 23 (suppl 12) ( 2002) S3–S40.
5. Cuming, R.; Rocco, T.; McEachern, A., Improving compliance with occupational safety and health administration standards, AORN J 87 (2) ( 2008) 347–360.
6. Fosmire, M.S., Frequently asked questions about the Emergency Medical Treatment and Active Labor Act (EMTALA), Available at:www.emtala.com/faq.htm; Accessed February 16, 2008.
7. Gaberson, K., Not your mother’s nursing school, AORN J 87 (2) ( 2008) 287–292.
8. Institute for Healthcare Improvement, Protecting 5 million lives from harm, Available at:www.ihi.org/IHI/Programs/Campaign/; Accessed November 21, 2008.
9. Medscape Today, Surgical Care Improvement Project (SCIP), Available at:www.medscape.com/viewarticle/557689; Accessed November 21, 2008.
10. National Council of State Boards of Nursing, What boards do, Available at:www.ncsbn.org/126.htm; Accessed February 13, 2008.
11. National Fire Protection Association, Available at:www.nfpa.org; Accessed November 21, 2008.
12. National Practitioner Data Bank Healthcare Integrity and Protection Data Bank, Available at:www.npdb-hipdb.com/; Accessed November 21, 2008.
13. The Joint Commission, Available at:www.jointcommission.org; Accessed November 21, 2008.
14. United States Centers for Disease Control and Prevention, Available at:www.cdc.gov/about/organization/cio.htm; Accessed February 12, 2008.
15. United States Department of Health & Human Services, Office of the Inspector General work plan fiscal year 2008, Available at:oig.hhs.gov/publications/docs/workplan/2008/Work_Plan_FY_2008.pdf; Accessed February 13, 2008.
16. United States Department of Health & Human Services:, Office for Civil Rights— HIPAA, Available at:www.hhs.gov/ocr/hipaa; Accessed February 16, 2008.
17. United States Department of Health & Human Services, Center for Devices and Radiological Health, Medical device reporting: An overview. Available atwww.fda.gov/cdrh/; Accessed February 13, 2008.
18. United States Department of Justice, Civil Rights Division, Civil Rights Division activities and programs. Available atwww.usdoj.gov/crt/activity.html; Accessed February 16, 2008.
19. United States Department of Justice, Americans With Disabilities Act, Available at:www.ada.gov; Accessed November 21, 2008.
20. United States Department of Labor Occupational Safety and Health Administration, Frequently asked questions. ( August 2007) ; Available at:www.osha.gov/as/opa/osha-faq.html; Accessed February 13, 2008.
21. United States Drug Enforcement Administration, Available at:www.dea.gov; Accessed February 13, 2008.
22. United States Equal Employment Opportunity Commission, Americans With Disabilities Act questions and answers, Available at:www.usdoj.gov/crt/ada/q%26aeng02.htm; Accessed February 16, 2008.
23. World Health Organization, WHO guidelines on hand hygiene in health care (advanced draft): A summary, Available at:www.who.int/patientsafety/events/05/HH_en.pdf; Accessed February 16, 2008.
