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.