CRCST Chapter 5 (8th Edition) Review Quiz
Regulations and Standards
- 1.Agency which may intervene in a matter of worker protection even if there are no specific regulations covering the situation.
- A.
Occupational Safety and Health Administration
- B.
Environmental Protection Agency
- C.
U.S. Food and Drug Administration
- D.
Association of periOperative Registered Nurses.
- 2.Regulations under the Clean Air Act are administered by the
- A.
Occupational Safety and Health Administration.
- B.
U.S. Food and Drug Administration.
- C.
Environmental Protection Agency.
- D.
Association of periOperative Registered Nurses.
- 3.The agency which imposes very strict labeling requirements on manufacturers of disinfectants used by Central Service departments.
- A.
Occupational Safety and Health Administration
- B.
U.S. Food and Drug Administration
- C.
Environmental Protection Agency
- D.
Association for the Advancement of Medical Instrumentation
- 4.Healthcare regulations and standards establish
- A.
Minimal levels of quality and safety.
- B.
Equal pay practices.
- C.
Productivity time lines.
- D.
All of the above.
- 5.Chemical indicators are classified as
- A.
FDA Class I medical devices.
- B.
FDA Class II medical devices.
- C.
FDA Class III medical devices.
- D.
None, not regulated by FDA.
- 6.Heart valves and pacemakers are examples of
- A.
FDA Class I medical devices.
- B.
FDA Class II medical devices.
- C.
FDA Class III medical devices.
- D.
None, not regulated by FDA.
- 7.Under current regulations, who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?
- A.
Device manufacturer
- B.
Hospitals
- C.
All of the above
- D.
None of the above
- 8.Standards and regulations help set levels of in our departments.
- A.
Quality
- B.
Safety
- C.
Efficiency
- D.
Both quality and safety
- 9.Medical device reporting is regulated by the
- A.
National Fire Protection Association
- B.
Environmental Protection Agency
- C.
World Health Organization
- D.
U.S. Food and Drug Administration
- 10.The Department of Transportation enforces statutes relating to the
- A.
Transportation of clean and soiled instruments between facilities.
- B.
Transportation of medical supplies for emergency use.
- C.
Transportation of equipment for the decontamination area.
- D.
Transportation of instrumentation across state lines.
- 11.Sometimes state or local regulations differ from Federal regulations and when that happens, the most stringent regulations apply.
- A.
True
- B.
False
- 12.It is optional to allow the Occupational Safety and Health Administration's regulation for wearing personal protective equipment in the Central Service decontamination.
- A.
True
- B.
False
- 13.Third-party reprocessors are regulated by the U.S. Food and Drug Administration.
- A.
True
- B.
False
- 14.Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
- A.
True
- B.
False
- 15.The Occupational Safety and Health Administration is a voluntary association dedicated to infection control and prevention.
- A.
True
- B.
False
- 16.Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.
- A.
True
- B.
False
- 17.The Society of Gastroenterology Nurses and Associates is a source for information about the proper processing of flexible endoscopes.
- A.
True
- B.
False
- 18.Class III medical devices are identified as high risk.
- A.
True
- B.
False
- 19.Reuse of single use medical devices is less regulated now than it was in the 1990's
- A.
True
- B.
False
- 20.The U.S. Food and Drug Administration recalls may be either mandatory or voluntary.
- A.
True
- B.
False
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