SMILE

MicrobiologyQC Guidelines

Microbiology QC Guidelines

Author: / Document Number: / Pro67-08
Effective (or Post) Date: / 19 Jan 07
Review History / Date of last review: / 9 Feb 09
Reviewed by: / Peggy Coulter
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.
Author(s), Name & Title / Peggy Coulter / Procedure Number / Date
International QC/QA Coordinator / Version 1 / Sept-06
Approved By / Name, Title / Signature / Date
SOP Annual Review / Name, Title / Signature / Date
Revision History / Version # [0.0] / Revision Date [dd/mm/yy] / Description (notes)
Distributed Copies to / Name (or location) / # of copies / Name (or location) / # of copies

Microbiology Quality Control Checklist

  • All steps must be documented and included supervisory review.
  • All reagents and media must be properly identified
  • Defined documented system of consistency of microscopic observations/interpretations among all personnel performing cellular stains

Media

  • Checked for quality of media; dry, cracked, contaminated
  • Check pH
  • Checked for sterility and the ability to support growth; Biochemical reactivity where applicable

Glassware

  • Use correct size brushes for tubes, replace approximately every 3 months
  • Use neutral soap, not alkaline
  • Distilled water needed for media glassware, not applicable for specimen containers
  • 7-10 rinses; 7 bucket approach is helpful
  • Distinguish between reusable and one-time use

QC Frequencyfor Microbiology reagents and stains

  • Known Positive and Negative each new batch, lot, or shipment of reagents
  • Catalase, Coagulase, Oxidase, Bacitracin, Optochin,ONPG, X,V,XV strips
  • use of ATCC strain or previously tested and identified organisms
  • Gram stain
  • Use both positive and negative staining organisms
  • weeklyfrequency using ATCC strain or previously identified organisms
  • filter if precipitate is visible
  • Other stains- every patient run
  • Use for both positive and negative reactions
  • Use of ATCC strain or previously identified organisms
  • Filter if precipitate is visible
  • Working O&P stains- once per week for contamination; WBCs mixed with negative stool may be used for a positive stain control

Direct Antigen kits

  • Internal controls
  • if included: external positive and negative for each lot and/or shipment
  • if not included: dailyexternal controls

Susceptibility Testing- CLSI Reference

  • Use ATCC or acceptable strains
  • Day of use or
  • Weekly after 20 or 30 consecutive test days of satisfactory results from drug/bug combinations
  • Results must be acceptable before reporting patient results

Instrument Maintenance

  • Biological Safety Cabinets
  • Cleaning: daily, weekly, monthly
  • Check for air flow
  • Incubators:
  • CO2 content
  • Checked and recorded daily
  • FYRITE- lab to establish frequency confirmingmonitoring gauges on incubator
  • Temperature Monitoring- daily
  • Cleaning- monthly
  • Refrigerators/Freezers
  • Temperature monitoring- daily
  • Cleaning- monthly
  • Microscope
  • Daily cleaning of lenses
  • Calibration of the ocular micrometer; initially and each time eyepieces or objectives are changed- Ocular and objective must be calibrated together
  • Waterbaths
  • Temperature Monitoring- day of use
  • Cleaning- monthly
  • Rotators
  • Checked for speed and timer, if applicable
  • Weekly
  • pH meters
  • day of use
  • 3 levels of buffer solutions

Waste Management

  • Checked on initial set-up and continued monthly using biological indicators
  • Each use requires heat sensitive tape
  • Tested under same conditions as waste; recorded temperature and QC results

References:

  1. CLSI Documents M28-A2 Procedures for the recovery and identification of parasites from the intestinal tract. 2005.
  2. Cumitech 3A Quality Control and Quality Assurance practices in clinical microbiology. ASM, May 1990.
  3. Cumitech 16A Diagnosis of the Mycobacterioses. ASM October 1994.
  4. W.H.O. TB Microscopy Guidelines. 1998.

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