Laboratory Operations Review

Question 1

Accreditation definition

Answer 1

recognition granted by nongovernmental agency to institutions that meet certain standards, voluntary

Question 2

Examples of accreditation

Answer 2

AABB, CAP, JCAHO, NAACLS

Question 3

Certification definition

Answer 3

recognition granted by nongovernmental agency to individuals who meet education requirements & demonstrate entry-level competency by passing exam, voluntary

Question 4

Examples of certification

Answer 4

ASCP, AAB, AMT

Question 5

Licensure definition

Answer 5

permission granted by state to individuals/organizations to engage in certain professions/businesses; mandatory

Question 6

Licensure required in states

Answer 6

CA, FL, HI, LA, MT, NV, NY, ND, RI, TN, WV

Question 7

AABB

Answer 7

technical standards and accreditation of blood banks

Question 8

CDC

Answer 8

standards and guidelines primarily related to infection control and safe work practices

Question 9

CLSI

Answer 9

standards on all aspects of lab practice developed through voluntary consensus

Question 10

ISO

Answer 10

standards to facilitate international exchange of goods & services; developed through voluntary worldwide consensus

Question 11

What does ISO stand for?

Answer 11

international organization for standardization

Question 12

Centers for medicare & medicaid services (CMS)

Answer 12

writes regulations for & enforces CLIA ‘88

Question 13

Department of Health and Human Services (HHS)

Answer 13

interprets and implements federal regulations related to health care

Question 14

What does the HHS oversee?

Answer 14

CDC, CMS, FDA, SAMSHA

Question 15

Department of Transportation (DOT)

Answer 15

regulates packaging, labeling, and transportation of biological products

Question 16

Environmental Protection Agency (EPA)

Answer 16

regulates disposal of toxic chemical and biohazards wastes

Question 17

Food and drug administration (FDA)

Answer 17

regulates market entry of instruments/reagents and production of donor blood and components; licenses blood banks

Question 18

nuclear regulatory commission (NRC)

Answer 18

licenses labs that use radionucleotides

Question 19

occupational safety and health administration (OSHA)

Answer 19

regulates employee safety in the workplace

Question 20

substance abuse and mental health services administration (SAMHSA)

Answer 20

certifies laboratories to conduct forensic drug testing for federal agencies

Question 21

Hazard communication standard (OSHA 1983) “Right-to-Know Law”

Answer 21

requires employers to inform employees about hazardous substances in workplace and educate them in safe handling

Question 22

Clinical Laboratory Improvement Amendments of 1988 (C:IA ‘88)

Answer 22

regulates all lab testing (except research) performed on humans in US requirements for personnel and quality assurance determined by test complexity. Administered by CMS

Question 23

Occupational exposure to hazardous chemicals in laboratories (OSHA 1990) “Laboratory Standard”

Answer 23

Requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in labs

Question 24

Bloodborne pathogens standard (OSHA 1991)

Answer 24

mandates work practices and procedures to minimize worker exposure to blood borne pathogens

Question 25

Formaldehyde Standard (OSHA 1992)

Answer 25

requires monitoring of formaldehyde exposure

Question 26

health insurance portability and accountability act of 1996 “HIPAA”

Answer 26

regulates use and disclosure of protected health information (PHI)