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.
Specialty: Clinical Laboratory