Chapter 6
Medicaid
A federal and state assistance program that pays covered medical expenses for low income individuals
Medicare
A federal medical insurance program that primarily serves those older than 65 years old
Best Practice
A method or technique that has consistently shown results superior to those achieved by other means.
The association of preoperative registered nurses (AORN) is:
A professional organization that writes guidelines for the OR
standard
A uniform method of defining basic parameters for processes, products, services, and measurements.
Enhances global competitiveness and quality of life by promoting standards and ensuring their integrity
American National Standards Institute (ANSI); Voluntary
Works to prevent healthcare-associated infections
Association for Professionals in Infection Control and Epidemiology (EPIC) ; Voluntary
Is considered one the major resources for healthcare guidelines
Association for the Advancement Of Medical Instrumentation (AAMI); voluntary
Develops nationally recognized guidelines for the preoperative setting
Association of pre-operative registered nurses (AORN); voluntary
promotes health by preventing and controlling disease
Centers for Disease and Prevention (CDC); voluntary
This organization uses unannounced inspections to monitor standards:
Centers for Medicare and Medicaid Services (CMS)
Which FDA classification is the most stringently regulated and requires a premarket approval (PMA)?
Class III devices
The U.S Department of Transportation (DOT) enforces statutes relating to the transportation of:
Cleaned instruments between facilities
This agency develops and enforces chemical regulations:
EPA
This agency imposes very strict labeling requirements on manufacturers of disinfectants used by Sterile Processing departments (SPDs):
EPA
The U.S food and drug administration (FDA) is responsible for:
Ensuring items can be properly cleaned and sterilized
Medical device reporting is regulated by the:
FDA
This organization issues regulations to help ensure medical devices are safe:
FDA
Medical device reporting is regulated by the:
FDA (U.S. Food and Drug Administration)
Chemical Indicator (CIs) are classified as:
FDA Class II medical devices
Heart valves and pacemakers are examples of:
FDA Class III medical devices
Provide state of the art specifications for product services and good practices
International organization for standardization (ISO); voluntary
The federal program designed for the voluntary reporting of device-related problems is called:
MedWatch
Develops international standards to reduce the risk of fire and other hazards
National Fire Protection Association (NFPA); voluntary
This agency may intervene in a matter of worker protection, even if there are no specific regulations covering the situation:
Occupational safety and health administration (OSHA)
Protect workers from occupationally cause illnesses and injuries
Occupational safety and health administration (OSHA); regulatory
Technical Information Reports (TIRs)
Reports developed by experts in the field that contain valuable information needed by the healthcare industry
The Centers for Disease Control and Prevention (CDC):
Response to health emergencies
Specializes in endoscopy issues and has established standards for the effective processing of flexible endoscopes
Society of Gastro, neurology, nurses, and associates (SGNA); voluntary
MedWatch
The FDA Safety Information and Adverse Event Reporting Program
Device-related problems or reported to the FDA through:
The MedWatch program
What is a consequence of a healthcare facility not following regulations and standards?
The facility can face legal consequences
Which organization conducts on site surveys of healthcare facilities?
The joint commission
Provide standards and evaluations for healthcare facilities; the evaluations are in the form of on-site surveys at least every three years
The joint commission (TJC); voluntary
enforces laws relating to the transportation of medical waste
U.S Department of Transportation (DOT); regulatory
Creates and enforces laws relating to cleaner water , air and land
U.S Environmental Protection Agency (EPA); Regulatory
Responsible for regulating ethylene oxide (EO) emissions
U.S Environmental Protection Agency (EPA); Regulatory
Responsible for the MedWatch program
U.S Food and Drug Administration (FDA); regulatory
responsible for premarket and postmarket medical medical device classification and recalls
U.S Food and Drug Administration (FDA); regulatory
Which governmental agency regulates emission standards for EO sterilization
U.S environment protection Agency (EPA)
Create and revises standards for processing water for irrigation
United States Pharmacopeia-National Formulary (USP-NF); Voluntary
Standards (AAMI)
Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is safe for patient use
furthers international cooperation in improving health conditions
World Health Organization (WHO); Voluntary
serious injury
an injury or illness that is life-threatening; resulting in permanent impairment of a body function or permanent damage to body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body structure
Standards and Regulations help set the SPD's levels of:
both quality and safety
under current regulations who is required to report suspected medical device- related deaths to the FDA?
healthcare facilities
Healthcare regulations and standards establish
minimal levels of quality and safety
Health Insurance Portability and Accountability Act (HIPAA)
provides federal protections for individually identifiable health information held by covered entities and their business associates and gives patients an array of rights with respect to that information
regulation
rules issued by administrative agencies that have the force of law
Premarket Approval (PMA)
the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices
