Why do we need sop in a laboratory?
- SOPs are written step-by-step instructions on how to carry out procedures correctly
- SOPs are meant to ensure consistency, accuracy, and quality of data
- SOPs harmonize laboratory practices, reduce user errors, and can be used as training tools
How to start?
1 – Create a standard template for all the SOPs in your laboratory
- This template is a standard plan
- Reuse, adapt and complete the template for each type of microbiology procedure
2 – Define the duties/ staff in charge of
- Writing the procedure: a member of staff who has knowledge and experience with the process
- Reviewing and approving: a person who reviews and approves the document before its dissemination (senior technician or biologist)
3 – Identify the document with a title & unique number
- Facility name: HOSP
- Sector: MIC
- Type of document: SOP
- Number unique: 001
- Version number: V1
- Example: HOSP – MIC – SOP – 001 – V1
If any change is to be made to this SOP, a new version will have to be created and the whole process (drafting, approval, distribution) – V2
4 – disseminate the SOP
- Define who is in charge of the dissemination
- Make sure that all relevant staff have read the document sign-in sheet
- Leave all SOPs in a place that is accessible and known to the staff
Example of table of contents (see below with a subject as example)
- 1-Subject (principle of the test of microbiological analysis)
- 2-Staff concerned
- 3-Specimen collection & transport
- 4-Reagents / Materials / Media
- 5-Procedure
- A-Processing of specimen
- I-Direct examination (if indicated)
- II-Culture (media – incubation)
- B-Interpretation of culture
- C-Susceptibility testing (if indicated)
- A-Processing of specimen
- 6-Reporting results
- 7-Reference document(s)
Testing for gonorrhea in a urethral swab
CHXX-MI-SOP-003-V2
1-Subject
Gonococcal urethritis diagnosis in urethral swab
2-Staff concerned
Technicians, biologists
3-Specimen collection and transport
Urethral swab – at room temperature, test < 2h
4-Reagents / Materials / Media
Chocolate Agar (CHOC), Mueller Hinton broth, antibiotic disks or ETESTs
5-Procedure
- A. Processing of specimen
- I-Direct examination: YES
Gram staining: Neisseria gonorrhoeae is gram negative diplococcus
II-Culture (media – incubation)
Media : CHOC
Incubation : CO2 – 35°C – 72h
- B. Interpretation of culture
- Examine the plate after 24, 48 and 72 hours of incubation
A positive culture (grey colonies) must be confirmed by identification (API NH)
- C. Susceptibility testing
- Test Chocolate media: Ceftriaxone, Ofloxacin… or transmission to NCLE? Refer to the SOP for performing an AST in your laboratory
6-Reporting results
- Negative: No Nesseira gonorrhoeae isolated
- Positive: Nesseira gonorrhoeae isolated, see AST below
- Call the prescriber (doctor) to inform.
7-Reference document(s)
- WHO Sexually transmitted infections
- SOP for performing an AST in your laboratory