III. Regulatory Elements

Question 1

The approval of an institution, part of an institution, or
program, demonstrating that it meets all formal standards as defined by the
accrediting body

Answer 1

Accreditation

Question 2

Official acknowledgement of the passing of a qualifying
examination

Answer 2

Certification

Question 3

The process by which a competent public authority grants
permission to an organization or an individual to engage in a specific
professional practice, occupation, or activity

Answer 3

Licensure

Question 4

7 Agencies

Answer 4

American Association of Blood Banks (AABB)
American Society for Clinical Pathology (ASCP)
Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘ 88)
College of American Pathologists (CAP)
Food and Drug Administration (FDA)
The Joint Commission
National Credentialing Agency for Laboratory Personnel (NCA)

Question 5

is an international
association established to promote the highest standards of care in all aspects
of blood banking.

Answer 5

American Association of Blood Banks (AABB)

Question 6

Blood Bank laboratories that are part of hospitals can be
accredited and inspected jointly by

Answer 6

American Association of Blood Banks (AABB) and College of American Pathologists (CAP)

Question 7

is a professional
organization for individuals working in clinical laboratory medicine.

Answer 7

American Society for Clinical Pathology (ASCP)

Question 8

offers certification examinations for clinical
laboratory personnel.

Answer 8

The ASCP Board of Registry

Question 9

refers
to legislation that mandates the conditions that must be met for laboratories to
be certified.

Answer 9

Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘ 88)

Question 10

The
requirements cover quality assurance, quality control, proficiency testing,
record retention, complexity of tests (high, moderate, and waived), job
categories, and personnel requirements to perform testing, supervise, and
direct laboratories

Answer 10

Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘ 88)

Question 11

accredits laboratories. The survey
is on a 2-year cycle with interim participation in proficiency testing required to
assure ongoing quality of all laboratory test procedures.

Answer 11

College of American Pathologists (CAP)

Question 12

reviews and approves new analytical
methods prior to marketing by the manufacturer to laboratories.

Answer 12

Food and Drug Administration (FDA)

Question 13

inspects all Blood Banks to assure the ongoing safety of the nation’s blood
source.

Answer 13

Food and Drug Administration (FDA)

Question 14

evaluates and accredits most of the healthcare
organizations in the U.S.

Answer 14

The Joint Commission

Question 15

offers
certification examinations for clinical laboratory scientists.

Answer 15

National Credentialing Agency for Laboratory Personnel (NCA)