Chapter 3

Question 1

Quality outcomes are of the-

Answer 1

Utmost importance in a clinical lab

Question 2

Diagnostic lab test results play a decisive role in-

Answer 2

Decision making related to individual patient care, public health policy, & research decisions

Question 3

The clinical value of a lab testing result involves-

Answer 3

Balancing the benefits that a test delivers against any harm that it may cause to a patient

Question 4

Harm to a patient can be caused by- (5)

Answer 4

-ordering an inappropriate test
-not ordering an appropriate test
-not using an appropriate test result properly
-delaying or missing a test result from an appropriate test
-reporting an incorrect or inaccurate test result

Question 5

Quality management works at the organizational level to- implement-

Answer 5

An overall quality policy

Question 6

Formalized systems document-

Answer 6

Processes, procedures, & responsibilities for achieving quality policies & objectives

Question 7

Key components to providing high quality lab results include- (5)

Answer 7

-an educated lab & extended specimen collection staff
-appropriate, validated testing methods
-properly functioning instruments
-quality assurance & quality control processes
-peer reference proficiency testing

Question 8

Quality management encompasses-

Answer 8

Quality assurance & quality control

Question 9

To achieve a 99% level of quality means-

Answer 9

Accepting a 1% error rate

Question 10

Blood & urine specimens are most often tested, but examinations can also be conducted on-

Answer 10

Body tissues & other body fluids, including synovial, cerebrospinal, seminal, peritoneal, & pericardial fluids

Question 11

Special patient preparation for some specimen collections, along with-

Answer 11

Transport to & handling in the lab before the actual analytical assay are very important

Question 12

Quality assessment ensures-

Answer 12

Reliability of results

Question 13

Valid results can be reported only when-

Answer 13

Preanalytical quality control has been ascertained

Question 14

CLIA’88 established-

Answer 14

A minimum threshold for all aspects of clinical lab testing

Question 15

Introduction of routine QC in the clinical lab was a major advance in-

Answer 15

Improving the accuracy & reliability of clinical lab testing

Question 16

Errors occurring during the analytical phase of testing within clinical labs are now-

Answer 16

Relatively rare

Question 17

The Joint Commission (TJC) was formerly known as-

Answer 17

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

Question 18

TJC requires hospitals to be accredited by- (3)

Answer 18

-TJC
-COLA
-CAP

Question 19

_____ will be required for the lab accreditation program-

Answer 19

Periodic Performance Review (PPR)

Question 20

PPR is a formal standards evaluation tool intended to-

Answer 20

Support continuous compliance & is being added to the accreditation process at the request of accredited labs

Question 21

International Organization for Standardization (ISO) is the world’s largest-

Answer 21

Developer & publisher of international standards

Question 22

ISO is a nongovernmental organization that forms a bridge between-

Answer 22

The public & private sectors

Question 23

The benefit to ISO 15189 is the use of-

Answer 23

Comprehensive & highly structured approach for quality management that allows labs to use tools such as six sigma

Question 24

The six sigma process uses actual assessment by-

Answer 24

Certified accessors, who educate people about the expectation & intent of the standard

Question 25

In gap analysis, assessors look carefully at-

Answer 25

Where the lab does not meet the ISO standard

Question 26

Gap analysis reveals-

Answer 26

What facets of day-to-day operations warrant improvement

Question 27

CAP 15189 is a voluntary, nonregulated accreditation to the-

Answer 27

ISO 15189:2007 standard