Biomedical Engineering Reference
In-Depth Information
■
Time-variance
: the repeatability of the system's response
to control stimuli;
■
Information content
: the amount of information needed
to deal with the system from a particular perspective such
as creation, use, or maintenance.
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Test categorization, which measures the complexity of
laboratory tests covered by the Clinical Laboratory
Improvement Amendment (CLIA), provides one illustration of
the measurement of complexity.
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Using the seven criteria listed
in Table 3.1, a laboratory test is graded for level of complexity
by assigning scores of 1, 2, or 3 within each of the criteria.
A score of “1” indicates the lowest level of complexity,
and a score of “3” indicates the highest level. These scores
are then totaled. Laboratory tests receiving scores of 12 or
less are categorized as moderate complexity, while those
receiving scores above 12 are categorized as high complexity.
An analogous approach could be used to measure the
complexity of another process.
The higher the complexity, the more the likelihood that
something will go wrong in the process.
Risk identifi cation
Table 3.1
Measuring the complexity of lab tests
Criteria
Score =
1
2
3
1. Knowledge
2. Training and experience
3. Reagents and materials preparation
4. Characteristics of operational steps
5. Calibration, quality control, and profi ciency
testing materials
6. Test system troubleshooting and
equipment maintenance
7. Interpretation and judgment
