Laboratory Operations

Question 1

Accredidation

Answer 1

Recognition granted by nongovernmental agency to institutions that meet certain standards
Voluntary

Ex: AABB, CAP, JCAHO, NAACLS

Question 2

Certification

Answer 2

Recognition granted by non governmental agency to individuals who meet education requirements and demonstrate entry-level competency by passing exam
Voluntary

Ex: ASCP, AABB, AMT

Question 3

Licensure

Answer 3

Permission granted by state to individuals/organizations to engage in certain professions/businesses.
Mandatory
Illegal to practice/operate in that state without license

Ex: license to be a clinical lab

Question 4

Agencies: Issue guidelines/standards
AABB (American Association of Blood Banks)

Answer 4

Standards and accreditation of blood banks

Question 5

Agencies: Issue guidelines/standards
CDC (Centers for Disease Control and Prevention)

Answer 5

Standards’guidelines primarily related to infection control and safe work practices

Question 6

Agencies: Issue guidelines/standards
CLSI, NCCLS (Clinical Laboratory & Standards Institute)

Answer 6

Standards on all aspects of lab practice developed though voluntary consensus

Question 7

Agencies: Issue guidelines/standards
ISO (International Organization for Standardization)

Answer 7

Standards to facilitate international exchange of goods and services
Developed through voluntary worldwide consensus
Defines standards for quality management in medical labs

Question 8

Federal Regulatory Agencies
CMS (Centers for Medicare & Medicaid Services)

Answer 8

Writes regulations for & enforces Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88)

Question 9

Federal Regulatory Agencies
HHS (Department of Health & Heman Services)

Answer 9

Interprets & implements federal regulations related to Health care
Oversees CDC, CMS, FDA, SAMSHA

Question 10

Federal Regulatory Agencies
DOT (Department of Transportation)

Answer 10

Regulates packaging, labeling and transportation of biological products

Question 11

Federal Regulatory Agencies
EPA (Environmental Protection Agency)

Answer 11

Regulates disposal of toxic chemicals and biohazardous waste

Question 12

Federal Regulatory Agencies
FDA (food and drug administration)

Answer 12

Regulates market entry of instruments/reagents and production of donor blood and components. Licenses blood banks

Question 13

Federal Regulatory Agencies
NRC (nuclear Regulatory commission)

Answer 13

Licenses labs that use radionucleotides

Question 14

Federal Regulatory Agencies
OSHA (Occupational Safety and Health Administration)

Answer 14

Regulates employee safety in the workplace

Question 15

Federal Regulatory Agencies
SAMHSA (Substance abuse and mental health services administration)

Answer 15

Certifies laboratories to conduct forensic drug testing for federal agencies

Question 16

Federal Regulations