Regulations and Standards

Question 1

Agency which may intervene in a matter of worker protection even if there are no specific regulations covering the situation.

Answer 1

Occupational Safety and Health Administration

Question 2

Regulations under the Clean Air Act are administered by

Answer 2

Environmental Protection Agency

Question 3

The agency which imposes very strict labeling requirements on manufacturers of disinfectants used by Central Service departments

Answer 3

Environmental Protection Agengy

Question 4

Healthcare regulations and standards establish

Answer 4

minimal levels of quality and safety

Question 5

Chemical indicators are classified as

Answer 5

FDA Class II medical devices

Question 6

Heart valves and pacemakers are examples of

Answer 6

FDA Class III medical devices

Question 7

Under current regulations, who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?

Answer 7

All of the above

Question 8

Standards and regulations help set levels of ____________ in our departments.

Answer 8

both quality and safety

Question 9

Medical device reporting is regulated by the

Answer 9

U.S. Food and Drug Administration

Question 10

The Department of Transportation enforces statutes relating to the

Answer 10

transportation of clean and soiled instruments between facilities.

Question 11

Sometimes state or local regulations differ from Federal regulations and when that happens, the most stringent regulations apply

Answer 11

True

Question 12

It is optional to follow the Occupational Safety and Health Administration’s regulation for wearing personal protective equipment in the Central Service decontamination area.

Answer 12

False

Question 13

Third-party re-processors are regulated by the U.S. Food and Drug Administration.

Answer 13

True

Question 14

Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation

Answer 14

True

Question 15

The Occupational Safety and Health Administration is a voluntary association dedicated to infection and control and prevention.

Answer 15

False

Question 16

Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.

Answer 16

True

Question 17

The Society of Gastroenterology Nurses and Associates is a source for information about the proper processing of flexible endoscopes.

Answer 17

True

Question 18

Class III medical devices are identified as high risk.

Answer 18

True

Question 19

Reuse of single use medical devices is less regulated now than it was in the 1990’s

Answer 19

False

Question 20

The U.S. Food and Drug Administration recalls may be either mandatory or voluntary.

Answer 20

True