Iahcsmm chapter 5 Regulations and Standards
APIC
A voluntary international organization dedicated to the prevention and control of infections and related outcomes (V) A. ANSI B. APIC C. WHO D. NFPA
False
ANSI (American national standards institute) voluntary Association dedicated to infection control and prevention
FDA
Agency responsible for the medwatch program (R)
EPA
Agency which imposes very strict labeling requirements on manufacturers of chemicals used by Central service departments A. OSHA B. FDA C. EPA D. AAMI (association for the advancement of medical instrumentation)
OSHA
Agency which may intervene in a matter of worker protection even if there are no specific regulations covering the situation A. OSHA (occupational safety and health organization) B. EPA (environmental protection agency) C. FDA (food and drug agency) D. AORN (association operating room nurses)
OSHA & EPA
Agency's responsible for regulating EO are.....&...... (R)
Class ll
Chemical indicators are FDA ........devices A. Class l B. Class ll C. Class lll D. Not regulated by FDA
True
Class lll medical devices are identified as high risk
EPA
Creates and enforces laws relating to clean water, air and land (R)
USP-NF
Creates and revise the standards for processing water for irrigation (V) A. EPA B. ECHN C. USP-NF D. WHO
AORN
Develops nationally recognized standards recommended practices and guidelines for the perioperative setting (V)
DOT
Enforces laws relating to the transportation of medical waste (R)
ANSI
Enhances the global competitiveness and Quality of Life by promoting standards and ensuring their integrity (V)
There are no established National emission standards
Established National emission standards for EO used by hospitals are regulated A. In all states B. In Washington DC C. In the western states D. There are no established National emission standards
True
Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments
False
Following OSHA regulations, wearing PPE in the central service decontamination area is optional
WHO
Furthers International cooperation in improving health conditions. (V)
Minimal performance standards
Healthcare regulations and standards provide consistency of departmental activities by outlining A. Minimal performance standards B. Equal pay practices C. Productivity time lines D. None of the above
Class lll
Heart valves and pacemakers are examples of FDA......... medical devices A. Class l B. Class ll C. Class lll D. Not regulated by the FDA
NFPA
International standards to reduce the burden of fire and other hazards (V)
AAMI
Is considered one of the major resources for healthcare guidelines (V)
FDA
Medical device reporting is regulated by the A. NFPA (national fire protection agency) B. EPA C. Who D. FDA
CDC
Promotes Health by preventing and controlling disease (V)
ANSI
Proposed standards are submitted from Members such as AAMI (V)
OSHA
Protects workers from occupationally-caused illnesses and injuries (R)
Joint Commission
Provides standards and evaluations for healthcare facilities, these evaluations are in the form of onsite surveys at least every 3 years (V)
True
Recommendations regarding sterilization practices are provided by AAMI
EPA
Regulations under the Clean Air Act are administered by A. OSHA B. FDA C. EPA D. AORN
FDA
Responsible for pre and post Market medical device requirements, medwatch, medical device classification, medical device recall. (R)
False
Reuse of single-use medical devices is less regulated now than it was in the 1990s
True
Sometimes state or local regulations differ from federal regulations and when that happens the most stringent regulations apply
All of the above
Standards and regulations help set levels of........ in our departments A. Quality B. Safety C. Efficiency D. All of the above E. None of the above
True
The SGNA (society of gastroenterology nurse's and associates) is a good source for information about the proper processing of flexible endoscopes
False
The organization that conducts on-site surveys to evaluate Health Care organizations is the ISO 9000
True
Third-party reprocessors are regulated by the FDA
SGNA
This organization has established standards for the effective processing of flexible endoscopes. (V)
All of the above
Under current regulations who is required to report suspected medical device related deaths to the FDA A. Device manufacturer B. Hospitals C. All of the above D. None of the above
