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- Template - Laboratory assessment questionnaire - clinical trials
- Template - Laboratory readiness checklist
- Template - Site visit report
Laboratory set up resources
Below are a list of the policy documents, standard operating procedures (SOPs), forms, competency assessment forms (CAFs) and risk assessments that are in operation at the Centre for Clinical Microbiology (CCM). The specific documents you will need to cover your laboratories/departments will vary depending on the research you are conducting, what level of laboratories you have and whether you are part of a clinical trial.
These documents will need to be reassessed every six months/a year/two years etc. to ensure they are still relevant and up to date. You may find it useful to have a spreadsheet with all of these documents, how often they need to be reassessed, who is responsible for reassessing, who is responsible for signing off, and the date they will next need reassessing, to ensure you are able to keep track of them all.
There are different types of documentation, each of which is described briefly below:
Policy documents provide general overviews of the rules and procedures of your laboratory. The information within them covers all aspects of that item (e.g. ‘waste storage and removal’ covers the waste generated in all areas of the department, including the BSL2 and 3 laboratories, office waste, such as recycling of paper and old equipment, as well as specialised waste routes, such as chemicals). Policy documents will refer to a number of other related documents, such as SOPs and forms.
Standard operating procedures (SOPs)
SOPs detail the specific steps for a certain procedure. They should be used as a guide to follow, to ensure laboratory workers are all undertaking tasks in the same way. This ensures both the safety of the workers, as well as the standardisation of the procedure. As SOPs are specific to the processes you undertake in your laboratory, you will find that the templates we have uploaded are really more examples. You will have to research and complete each procedure you do in your laboratory to ensure the SOPs fit with your research.
Forms are documents on which laboratory workers record data from the laboratory. These are likely to include things such as weekly maintenance checklists, temperature logs for equipment such as freezers and incubators, as well as auditing procedures. Once printed, filled in and signed, these documents should be kept in hard and/or digital form as a record.
Competency assessment forms (CAFs)
CAFs record the items for a specific procedure/training which laboratory workers need to have been approved on. For example, a CAF for autoclave training will have multiple items that a laboratory worker will need to have been signed off on, such as ‘reading and understanding the different autoclave cycle settings’, ‘how to replace the printing paper’ and ‘what to do in the event of autoclave failure’. CAFs are a record of a laboratory worker’s training and as such, should be kept with the rest of the staff member’s training records. The CAFs should note how often staff members should be retrained on any particular procedure.
UCL risk assessments are completed online using a website called RiskNet, then downloaded, printed and stored in a folder so that all members can read and sign the risk assessment, and refer to it when necessary. Risk assessments should cover all activities undertaken in the department and an individual assessment should be completed for individual procedures (e.g. ‘use of the autoclave’), or to cover different hazard group organisms (e.g. ‘working with HG3 organisms and materials that contain them) etc.
It is important that risk assessments cover the hazards and risks involved in the procedure (e.g. using a water bath (the hazard) could result in burns/scalds (the risk)) and the mitigations you have put in place to replace the hazard with a safer version (hazard elimination), or reduce these risks (risk control) (e.g. laboratory workers must wear heat-proof gloves when using the water bath, to prevent skin coming into contact with hot water/metal). It is useful to provide a risk matrix table (which shows the relationship between probability and severity of the risk), to ensure that any procedure covered by the risk assessment is not deemed too dangerous.
Risk assessments must be approved by an appointed health and safety officer, head of department or other relevant member of staff.
Note: The uploading of templates for these documents to the hub resource centre is ongoing, so please check back again soon, or contact us at firstname.lastname@example.org if you wish to request specific templates.
Note: We have added helpful notes in the margin of many of our templates and guides. Please ensure you can see all comments when you open the documents to get the full information provided.
Links to BSL3 laboratory resources
Quality control and documentation
Our partner site UCL has created template policy and SOP documents that can be used as a basis for documentation in any laboratory. As UCL is predominantly a TB clinical trials department, the examples in the templates are related to TB, but you will need to rewrite these documents to reflect the organism(s) you work on, the research you are doing and also the health and safety requirements of your organisation and country.[LE1]
- Good clinical practice
- Template - Checklist of Laboratory documentation
- Template – Quality manual
- Template – Health and safety policy
- Template – Overview of BSL3 laboratories
- Template – Storage and removal of waste
- Template – Procedure for disinfection
- Template – Major spillage or chemical event
- Template – Procedure in the event of an incident (including innoculation)
- Template – Operation of microbiological safety cabinets
- SLIPTA checklist
- SLIMTA website
- WHO AFRO laboratory accreditation process
- ISO15189 (medical laboratories) standards
- African Society for Laboratory Medicine – accreditation
How to run a workshop
- Guide - How to run a workshop
- Guide - How to write a workshop report
- Template - Workshop advert
- Template - Workshop application form
- Template - Workshop attendance certificate
- Template - Workshop budget
- Template - Workshop icebreaker worksheet
- Template - Workshop evaluation form
- Template - Workshop invitation letter
COVID-19 preparedness – Zambia
Live filming was recorded and can be found here:
Specific videos can be found below:
Clinical care and risk assessment of COVID-19 for African member states – Workshop overview
Presentation 1: Risk assessment of zoonotic/infectious disease events: concept of risk assessment
Presentation 2: Clinical management of ill travellers: Points of entry and at the hospital level
Presentation 3: Joint risk assessment (JRA): the human-animal-environment interface
Presentation 4: Africa CDC response activities for COVID-19
Presentation 5: Introduction to the International Health Regulations (IHR)
Dr Chiara Montaldo - Question and Answer session
- Laboratory and IT requirements (from Nanopore Community, you will need login details)
- Protocol – Rapid Barcoding Kit (from Nanopore Community, you will need login details)
- Protocol – Rapid PCR Barcoding kit (from Nanopore Community, you will need login details)
- Protocol – how to QC a flow cell
- Protocol – how to wash a flow cell
- Oxford Nanopore Protocols page
- Presentation - Introduction to Oxford Nanopore Technology (Dr Linzy Elton, UCL, UK)
- Presentation - Good quality DNA (Alp Aydin, Quadram Institute, UK)
- Presentation - Introduction to Nanopore data (Alp Aydin, Quadram Institute, UK)
- Presentation - Data analysis demonstration (Alp Aydin, Quadram Institute, UK)
- Presentation - Practical considerations for setting up Nanopore sequencing (Dr Linzy Elton, UCL, UK)
- Presentation - The INHALE project (Dr Vicky Enne, UCL, UK)
- Presentation - Whole genome sequencing of tuberculosis (Professor Neil Stoker, UCL, UK)
- Presentation - Drug resistance of tuberculosis (Professor Neil Stoker, UCL, UK)
- Presentation - Bioanalysis of chikungunya virus sequences (Dr Francesca Colavita, Dr Martina Rueca and Dr Emanuela Giombini)
- Presentation - Basic concepts of molecular virology (Dr Liã Bárbara Arruda)
TB molecular diagnostics workshop
- Presentation - BSL3 laboratories in the UK (Priya Solanki, UCL, UK)
- Presentation – Solid and liquid culturing (Dr Pacome Abdul, CERMEL, Gabon)
- Presentation - AFB Microscopy (Dr Davis Kuchaka, KCRI, Tanzania)
- Presentation - MGIT culturing (Priya Solanki, UCL, UK)
- Presentation - Drug sensitivity testing (Priya Solanki, UCL, UK)
- Presentation - GeneXpert (Dr Naadira Vanker, TASK, South Africa)
- Presentation - GeneXpert - Practical I (Dr Naadira Vanker, TASK, South Africa)
- Presentation - GeneXpert - Practical II (Dr Naadira Vanker, TASK, South Africa)
- Presentation - HAIN (Dr Pacome Adbul, CERMERL, Gabon)
Link to Chatham House's Sustainable laboratories initiative: https://www.chathamhouse.org/about/structure/global-health-security/sustainable-laboratories-initiative#
Link to Chatham House's Sustainable laboratories prior assessment tool: https://www.chathamhouse.org/sites/default/files/publications/research/2019-06-18-Sustainable-Laboratories-Initiative.pdf