Part 1 - PulseNet International

Quality Assurance Standards for Pulsed-Field Gel
Electrophoresis (PFGE)
Testing for the CDC PulseNet Laboratories
I. PREFACE
The objective of this document is to provide CDC laboratories with a set of quality control and
quality assurance standards to be followed when subtyping foodborne bacterial pathogens with
any of the approved standardized protocols. Strict adherence to standardized procedures is
essential to the operation of PulseNet and to ensure that the data submitted to the PFGE National
database is of the highest quality possible. All PulseNet CDC laboratories must comply with the
following quality assurance standards in order to continue to participate in PulseNet.
The PulseNet USA Task Force is committed to assisting all PulseNet participating laboratories
(PulseNet USA and PulseNet International) in achieving the highest quality of data before
submitting patterns to the databases in the respective countries or regions. Part of that
commitment consists of the development and implementation of standardized laboratory
protocols and software analysis parameters that would enable the exchange and comparison of
molecular fingerprinting data between laboratories. It is in this context that the PulseNet Task
Force presents this document as a template to assist all PulseNet USA and PulseNet International
participating laboratories in the development of their own QA/QC manual and program. The
standards presented herein were established specifically for PulseNet laboratories at CDC with
the understanding that most of the following standards will apply, within varying degrees, to all
laboratories participating in PulseNet. We encourage all PulseNet laboratories to adopt these
standards whenever possible and to modify them in a manner consistent with the internal policies
or guidelines established by their institution, state or country.
Effective Date: These standards shall take effect May 9, 2005.
II. INTRODUCTION
This document consists of definitions and standards as they apply to the protocols and
procedures used in PulseNet USA. The standards are quality assurance measures that place
specific requirements on CDC laboratories conducting PFGE analysis with the purpose of
submitting DNA fingerprint patterns/gel images to the PulseNet USA National database(s).
Additional or equivalent measures not outlined in this document may also meet the standard if
submitted and approved by the PulseNet USA Task Force of the Foodborne and Diarrheal
Diseases Branch at the Centers for Disease Control and Prevention.
This document complies with Good Laboratory Practices (GLPs: 21 CFR Part 58) for conducting
nonclinical laboratory studies, which are regulated by the Food and Drug Administration.
This document also satisfies all requirements for the International standard: ISO/DIS 17025
(general requirements for the competence of testing and calibration laboratories).
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