Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

Appendix B: Microbiology

1. Organisms

The organisms required for testing shall be checked for purity (no contamination with other organisms), enumeration, and demonstration of biochemical or other biological characteristics, as appropriate for their application.

The organisms are traceable and documented from date of possession.

2. Media

2.1 Every batch of media shall be examined to ensure it is suitable for use. Records shall include preparation instructions (when internally prepared), traceability to dehydrated media (if internally prepared), pH, appearance, sterilization batch (see below), fill volumes (if appropriate), batch size, and quantity.

2.2 Each batch of media shall undergo QC verification of the following parameters: productivity (+ culture), selectivity (if appropriate), and sterility. Records shall be traceable to the person approving or rejecting the media.

3. Reagents/Kits/Identification Systems

The laboratory shall approve every lot of material. Records shall minimally include the date approved and traceability to the person approving or rejecting the material.

Note: For identification systems that speciate organisms (e.g., API 20E, VITEK, Biolog), it is sufficient to confirm acceptability of the kit by using a single control organism appropriate for that system. It is not necessary to confirm multiple organisms are identified correctly, unless the laboratory has a need for that information.

4. Sterilization for Media and Reagents

Autoclave records shall show date, run number, autoclave identifier, nature of material/load, time at desired temperature, and traceability to persons performing the activities.

For other sterilization means, records shall show date, nature of material, and confirmation of sterilization procedure (including heating condition, filtration, and chemical denaturation) and traceability to persons performing the activities.

08/09/2018