Chapter 5- Regulation And Standards

Question 1

Statue

Answer 1

Written law adopted by a legislative body that governs a city, county state or country.
.

Question 2

Regulations

Answer 2

Rules issued by admin agency that have the force of law

Question 3

Standard

Answer 3

Uniform method of defining basic parameters for processing, products, services and measurements

Question 4

Regulatory standards

Answer 4

Requirements imposed by movement agencies yield legal penalties if not followed.

Question 5

Voluntary standards

Answer 5

Strongly suggested for better patient care but not mandated with legal consequences (guidelines)

Question 6

Best practice

Answer 6

method that has consistently shown results superior to those achieved by other means

Question 7

FDA (food and drug administration)

Answer 7

Ensures food, cosmetics, human an vet drugs, biological products, medical devices and electronic products are safe and effective for public

Question 8

HLD

Answer 8

. High-level disinfectants

Question 9

Class I device

Answer 9

Low risk, hand held instruments and ultrasonic cleaners

Question 10

Class ll devices

Answer 10

Pose potential risk, sterilization equipment biological and chemical indicators

Question 11

Class 111 devices

Answer 11

Stringently regulated (heart valves, race makers)

Question 12

Medwatch

Answer 12

Program to report device or drug related problems voluntary

Question 13

CDC (center for disease control)

Answer 13

Federal agency used to promote health and quality of life by preventing and controlling disease, injury and disability, responds to health emergencies

Question 14

Dot ( US Department of transportation)

Answer 14

Federal agency ensures fast, safe and efficient transportation system..

Moving hazardous waste, instrument repair, radioactive waste

Question 15

EPA (US environmental protection agency)

Answer 15

Protect human health and environment. Write and enforce regulations
Regulate disposal of bio hazardous waste

Minimize green house gas = any gas that absorb solar radiation cause greenhouse effect, Carbon dioxide, methane, ozone

FIFRA regulates disinfectants and sanitizer, must obtain EPA registration

Question 16

OSHA (occupational safety and Health Administration)

Answer 16

Under us Labor

Protect workers from job caused illnesses and injuries

Question 17

CMS ( centers for Medicare and Medicaid services)

Answer 17

Federal agency

Administers standards of Health Insurance portabilityand accountability act to protect patient medical records

Question 18

Medicare

Answer 18

Insurance for over 65 and people under 65 with disabilities

Question 19

Medicaid

Answer 19

Federal and state assistance Insurance for low income

Question 20

DHS ( department of Health services )

Answer 20

Establish local health safety standards

Question 21

AAMI ( association for advancement of medical instrumentation)

Answer 21

Voluntary organization
Research and develop new standards and technical Information reports that address use, care and process ing of devices and systems or revise existing standards

Question 22

Acorn ( association of perioperative registered nurses)

Answer 22

Professional organization
Develop evident based standards recommended practices, and guidelines

For cleaning, disinfecting, packaging, endoscope process and sterilization.

Question 23

APIC

Answer 23

Focuses on minimizing hai and work with CDC

Question 24

TJC ( the joint commission)

Answer 24

Private organization
Develops standards for health care facilities
Conduct on-site surveys every 3 years

Can lose accreditation if not following standards

Question 25

Who (world health organization)

Answer 25

Combat disease, to promote general health of people worldwide