Bld 220 - Midterm Aaaa

Front 1

Recognize the acronym "CLIA" and state what it stands for

Back 1

Clinical Laboratory Improvement Amendments

Front 2

Discuss how proficiency testing is conducted and its purpose

Back 2

The qualifications for testing personnel are correlated to the complexity of the test performed with more complex tests requiring more highly qualified personnel.

The complexity of tests is determined by rating every assay from 1-3 on each of the following seven criteria: knowledge required to perform the test, training required, degree of reagent preparation required, number of operational steps, stability and availability of quality control materials, degree of automation or calibration and troubleshooting, and complexity of result interpretation.

The ratings are then totaled so the lowest possible is 7 and the highest possible is 21.

Front 3

Discuss the implications of site'-neutrality under CLIA 88 and its rationale.

Back 3

Considered site neutral because where the testing is done doesn't matter - all labs must meet the same standards

Rationale for site neutrality is that the exp~cted quality of testing should not vary just because the test is performed in a previously unregulated site.

Front 4

List the major provisions of CLIA and include personnel standards

Back 4

2bF

Front 5

Describe the general characteristics of Waived tests

Back 5

Procedures that are so
simple that errors are
unlikely or the tests are
approved for home testing.
Examples include home
pregnancy tests,
agglutination tests for
infectious mononucleosis,
urinalysis test strips

No minimum educational
requirement apart from
appropriate training by the
employer for the tests
performed

Front 6

Describe the general characteristics of Moderate complexity test

Back 6

Test systems, assays or examinations rated 12 or less

High school education with appropriate on-the-job training or compliance with any state licensing requirements

80-90% of all routine tests

Originally categorized on a 7 point scoring system that included amount of education needed, how automated the reporting was (i.e. were any calculations required?), degree of reagent preparation, types of quality control materials, etc.

Front 7

Describe the general characteristics of High complexity tests

Back 7

Test systems rated above 12

Minimum of Associates Degree

Front 8

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

HHS/CMS

Back 8

CLIA is administered by the Department of Health and Human Services (HHS) through the Centers for Medicare and Medicaid Services (CMS)

1. Each state hiresit's own CLIA inspectors with dollars allocated to the State from CMS

2. In Michigan, the state's laboratory licensing law was suspended with the implementation of CLIA

Front 9

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

CAP

Back 9

College of American Pathologists
Professional Organization
HHS/CMS - “Deemed Worthy”

Front 10

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

JCAHCO

Back 10

Joint Commission on Accreditation of Health Care Organizations (JCAHO), now
known as the Joint Commission
Professional Organization
HHS/CMS - “Deemed Worthy”

Front 11

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

d. AOA

Back 11

American Osteopathic Association
Professional Organization
HHS/CMS - “Deemed Worthy”

Front 12

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

e. COLA

Back 12

Commission on Laboratory Assessment

Front 13

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

f. AABB

Back 13

American Association of Blood Banks

Front 14

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

g. OSHA

Back 14

Occupational Safety and Health Administration
Government organization overseeing laboratories

Front 15

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

h. NRC

Back 15

Nuclear Regulatory Commission
Government organization overseeing laboratories

Front 16

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

1. FDA

Back 16

Federal Drug Administration
Government organization overseeing laboratories

Front 17

State the full name of the agency and the activities that it
oversees and whether it is a professional/governmental organization:

J. EPA

Back 17

Environmental Protection Agency
Government organization overseeing laboratories