3.1 Standard operating procedures (SOPs)
SOPs are unambiguous written instructions covering routine laboratory operations as well as the organisation and management of the laboratory. By stipulating how a task should be done, SOPs ensure consistency in the workplace; this in turn reduces testing error and bias and leads to more reliable and accurate results. SOPs should be available for all procedures, and may be developed locally or for a national surveillance system developed nationally with adaptations for the for the local situation if needed.
SOPs use clear language, are easy to follow and have a standard format where the header summarises important information regarding document approval and classification (see Table 2). It is essential that SOPs are reviewed regularly and kept up to date, with previous versions being archived. Staff should be kept informed of updates.
| TLM/MSH Microbiology Department Policy & Procedure Manual | Policy # M1/RESP/11/v05 | Page 1 of 5 |
| Section: Respiratory Tract Culture Manual | Subject Title: SPUTUM (Including Endotracheal Tube and Tracheostomy Specimens) | |
| Issued by: LABORATORY MANAGER | Original date: September 25, 2000 | |
| Approved by: Laboratory Director | Revision date: September 14, 2006 | |
| Annual review date: August 13, 2007 | ||
A well-written, comprehensive SOP should provide all the information needed for a new member of staff to be able to complete the procedure exactly (see Table 3).
| Section | Description (where appropriate) |
|---|---|
| Purpose | |
| Scope | |
| Equipment | |
| Reagents and media | Steps for preparing reagents or refer to other SOPs |
| Supplies | General laboratory supplies/disposables as needed |
| Safety precautions | |
| Sample information/processing | Acceptance/rejection criteria, volume, storage, etc. |
| Quality control(s) | Type, expected values |
| Workflow chart | Optional but can be used as a job-aid |
| Procedure | Step-by-step written instructions |
| Method performance specifications | Analytical sensitivity, method’s limitations |
| Result interpretation | Guidelines to be used |
| Results reporting | Instructions for reporting the handling of critical results |
| References | Useful source of information |
| Appendices (optional) | e.g. a manufacturer’s leaflet |
| Revision history |
The SOP should include the scope, purpose and a step-by-step description of how to perform the entire testing process, including how the results should be analysed and interpreted (CLSI).
Who should develop SOPs and who should approve the contents?
- SOPs should be written by laboratory staff who have a good understanding of the activity to be covered.
- Each SOP should be approved by a quality manager, laboratory manager or similar senior staff member who has the necessary authority.
See Public Health England’s comprehensive catalogue of SOPs [Tip: hold Ctrl and click a link to open it in a new tab. (Hide tip)] for examples.
3 Minimising errors
