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Part 1 - PulseNet International

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STANDARD H.3<br />

Equipment requiring calibration shall be calibrated according to the procedures recommended in<br />

the respective manufacturer’s manual(s). If calibration instructions are not included in the<br />

manual, the laboratory shall request written instructions directly from the manufacturer.<br />

H.3.1<br />

Written records documenting the frequency and date of calibration shall be<br />

maintained for each instrument requiring calibration.<br />

H.3.2<br />

New instruments and equipment, or instruments and equipment that have undergone<br />

repair or maintenance, shall be calibrated before being used in sample analysis.<br />

H.3.3<br />

Written records or logs shall be maintained for maintenance service performed on all<br />

equipment.<br />

I. CERTIFICATION<br />

OBJECTIVE: To ensure that all persons submitting patterns to the National Databases have<br />

been adequately trained on the <strong>PulseNet</strong> standardized protocol(s) for PFGE and/or Gel Analysis<br />

and are producing good quality gels and analysis.<br />

STANDARD I.1<br />

All members of the CDC <strong>PulseNet</strong> laboratory (<strong>PulseNet</strong> Methods Development Laboratory)<br />

shall attend CDC-sponsored training, Area Lab training, or customized training (by a<br />

certified instructor) and must have successfully completed the certification testing for an<br />

organism (in gel preparation, TIFF analysis or both), as described in the “Standard Operating<br />

Procedure for Certification of <strong>PulseNet</strong> USA Personnel” (PNQ02).<br />

I.1.1<br />

This person shall be responsible for training additional staff in their respective<br />

laboratory.<br />

I.1.2<br />

No person may submit patterns to any <strong>PulseNet</strong> USA national database without<br />

having been TIFF-certified for that organism.<br />

J. PROFICIENCY TESTING<br />

OBJECTIVE: To participate in the ongoing proficiency testing program, coordinated by the<br />

<strong>PulseNet</strong> USA Task Force and APHL, to ensure that CDC laboratories participating in <strong>PulseNet</strong><br />

USA maintain a satisfactory level of performance for PFGE or other molecular subtyping<br />

methods and gel analysis.<br />

May 9, 2005 16

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