CLINICAL CHEMISTRY

QUESTIONS OF RESEARCH
EXPERIMENT 5

1. Define the terms:
a. Quality Control involves the systematic monitoring of analytic processes in
order to detect analytic errors that occur during analysis and to ultimately
prevent the reporting of inaccurate patient results.
- part of performance monitoring that occurs after a test has been
established
Henrys (6
th
Ed.).p.116
b. Quality Assurance measurement of the broader dimensions of quality, from
the perspective of the end-users. It might involve the monitoring of
specimen acquisition, turnaround times, or proficiency testing of materials
to determine analytic performance.
p. 120
c. Quality Systems used to monitor the analytic variations that can occur
P.117

d. Quality Management approach focusing on process improvement as a
means to meet a set standard
p. 120
e. Accuracy closeness to the true value
Henrys. Glossary p.1
- Normally refers to the difference (error or bias) between the mean of
the set of results and the value which is accepted as the true or
correct value for the quantity measured.
Kateman, G. &Buydens, L. (1993). Quality Control in Analytical
Chemistry (2
nd
ed.). NY: John Wiley & Sons, Inc.
p.11
f. Precision reproducibility of measurement within a set, that is, to the
scatter or dispersion of a set about its central value
- International Organization for Standardization (ISO) (IN 66)
Descriptions of Precision:
1. Reproducibility, the closeness of agreement between individual results
obtained with the same method but under different conditions
2. Repeatability, the closeness of agreement between individual results
obtained with the same method and under the same conditions
Kateman, G. &Buydens, L. (1993). Quality Control in Analytical
Chemistry (2
nd
ed.). NY: John Wiley & Sons, Inc.
p.11

g. Analytical Sensitivity It gives the change of a signal upon a change of
concentration. The sensitivity of a method is a practical quality measure,
since it pertains to the ease of detection.

Kateman, G. &Buydens, L. (1993). Quality Control in Analytical Chemistry
(2
nd
ed.). NY: John Wiley & Sons, Inc.
p.10
The ability of an analytical method to detect small quantities of the
measured component. Numerically characterized by determination of
detection limit.
http://www.westgard.com/glossary.htm

h. Analytical Specificity Selectivity and specificity are quality parameters of a
method of analysis. They can be expressed as the ration of sensitivities of the
method for various components to be measured in the sample. The optimal
value of these characteristics is set by the number of measurements required
to estimate the composition of the sample

Kateman, G. &Buydens, L. (1993). Quality Control in Analytical Chemistry
(2
nd
ed.). NY: John Wiley & Sons, Inc.
p.10

i. Analytical Run - Generally defined by CLIA as an 8 hour to 24 hour interval
during which control materials must be analyzed. According to CLSI C24, a
run is an interval (i.e., a period of time or series of measurements) within
which the accuracy and precision of the measuring system is expected to be
stable. In laboratory operations, control samples are analyzed during each
analytical run to evaluate method performance, therefore the analytical run
defines the interval (period of time or number of specimens) between
evaluations of control results. Between quality control evaluations, events
may occur causing the measurement process to be susceptible to variations
that are important to detect.
Westgard, J. Retrieved on Jan 10, 2014 from
http://www.westgard.com/glossary.htm
j. Control Serum a quality control material used as the basis for validation of
test results

3. Define the various multirules of Westgard
- developed by Westgard and Groth49 to further judge whether control results
in- dicate out-of-control situations
- Control rules indicate the number of control observations per analytic run,fol-
lowed by the control amount in subscript.
- 12s One control observation exceeding the mean 2s. A warning rule that
initiates testing of control data by other rules.
- 13s One control observation exceeding the mean 3s. Allows high
sensitivity to random error.
- 22s Two control observations consecutively exceeding the same 2s or 2s.
Allows high sensitivity to systemic error.
- R4s One control exceeding the 2s and another exceeding the 2s. Allows
detection of random error.
- 41s Four consecutive control observations exceeding 1s or 1s. This allows
the detection of systemic error.
- 10x Ten consecutive control observations falling on one side or the other of
the mean (no requirement for SD size). This allows the detection of systemic
error
p. 118

Bishop, M. L., et. al. (2010).Clinical Chemistry: Techniques, Principles,
Correlations (6
th
ed.). Philadelphia, PA: Lippincott Williams and Wilkins