Description

The Food and Drug Administration (FDA) has developed a scoring system to help determine whether a clinical laboratory test should be classified as moderate or high complexity.


 

Exclusion: The criteria do not apply to waived tests.

 

Parameters:

(1) knowledge (amount of specialized knowledge)

(2) training and experience (amount of specialized training and/or experience)

(3) reagents and material preparation (amount of special handling or preparation)

(4) characteristics of operational steps (amount of preparation, process control, timing, pipetting and/or calculations)

(5) calibration, quality control, and proficiency testing materials (lability and availability)

(6) test system troubleshooting and equipment maintenance (amount of specialized knowledge and decision-making required)

(7) interpretation and judgment (amount of independent interpretation and/or judgment required, including the ability to resolve problems)

 

Requirement for Each Parameter

Points

none or minimal

1

moderate

2

significant

3

 

total score =

= SUM(points for each parameter)

 

Interpretation:

• minimum score: 7

• maximum score: 21

• A score > 12 indicates a high complexity test.

• A score <= 12 indicates a moderate complexity test.

 


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