Part 1 - PulseNet International

STANDARD K.2
The laboratory shall conduct administrative and technical reviews of all reports to ensure that
conclusions and supporting data are reasonable and within the constraints of scientific
knowledge.
K.2.1
The laboratory shall have a mechanism in place to address unresolved discrepant
conclusions between analysts and reviewer(s).
L. CHANGES TO THE STANDARDIZED PFGE PROTOCOL
STANDARD L.1
Any changes made to the standardized PFGE protocol(s) shall be appropriately documented.
No changes may be made to the standardized PFGE protocol(s) without approval from the
PulseNet USA Taskforce and the PulseNet USA Steering Committee.
L.1.1
Internal validation of such changes shall be performed and documented by the
laboratory.
L.1.1.1
Changes to the protocol(s) shall be tested using known samples. The laboratory
shall monitor and document the reproducibility and accuracy of the procedure
using the appropriate bacterial DNA control(s).
L.1.1.2
The laboratory shall establish and document match criteria based on empirical
data in conjunction with the PulseNet USA Task Force.
L.1.1.3
Material modifications made to analytical procedures shall be documented and
subject to validation testing by at least three additional PulseNet USA-certified
laboratories designated by the PulseNet USA Task Force.
M. VALIDATION OF NEW METHODS
STANDARD M.1
All developmental validation performed shall be appropriately documented.
M.1.1
Internal validation shall be performed and documented by the laboratory.
M.1.1.1
The procedure shall be tested using known samples. The laboratory shall monitor
and document the reproducibility and accuracy of the procedure using the
appropriate bacterial DNA control(s).
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