Designing a Diagnostic Laboratory during COVID-19
Although life in many places worldwide is getting back to new normality, the COVID-19 pandemic is not over yet (as of June 2020).
Despite encouraging vaccine trial results, new industry-academia-charity collaborations (unprecedented like the disease it is tackling) and positive results of drug re-purposing to combat the disease, it seems there is a long way to go.
Throughout the pandemic one of the most used terms by the media and the UK government’s daily updates is ‘testing’. Testing is critical for tracking the numbers, for patient treatment plans and for controlling the spread.
Diagnostic laboratories are the – dare I say – ‘temples’ where these tests are received and tested – in a safe, secure and consistent manner.
Whilst there are ever-evolving tests (antigen/swab & antibody/serological) that may involve varying levels of sample and reagent handling, as well as individual lab processes, these share some common principles.
We design research and development laboratories regularly where terms like containment, BSL2 or BSL3 (biosafety levels 2 & 3), BSCs (Biological Safety Cabinets) are routinely used, however the pandemic brought these terms to the public. After writing about coronavirus handling and the different biosafety levels and classification of BSCs, we would like to provide some basic requirements of a diagnostic lab (Note).
Key elements of most lab planning and design include a detailed assessment of the work-flow, processes, and movement of goods (chemicals, consumables, gases, waste) and people through the facility. Focus needs to be on adjacencies required between different activities while marrying safety, accessibility, and services location within the existing infrastructure. Safety and security are essential considerations.
In the case of diagnostic labs, biosafety and biosecurity become the most important due to the handling of pathogenic samples and their disposal. It becomes crucial to investigate the individual journeys of samples, reagents, scientists or clinicians, and patients (if based in hospital). For example:
Under normal conditions, careful consideration, assessment, and stakeholder engagement would be a standard course for a diagnostic lab design process. During the current crisis, speed is the driving factor
- for processing samples in existing labs,
- scaling up the testing capacity - as never seen before,
- adapting existing labs to this tsunami of samples and,
- for creating new labs within record times.
In all scenarios, lab design needs to adhere and comply to national & local authority regulations. Guidelines for good microbiological practice and procedure, including lab design, is provided by PHE (Public Health England), WHO (World Health Organisation) and CDC (Centre for Disease Control & Prevention, USA).
The ACDP (Advisory Committee on Dangerous Pathogens) has agreed on a provisional classification of SARS-CoV-2 as a Hazard Group 3 (HG3) pathogen, based on the current information1 and other coronavirus family agents, e.g. SARS & MERS. In light of the exceptional circumstances posed by SARS-CoV-2 and the potential impact on the diagnostic sector, a risk-based proportionate approach has been adopted in agreement with ACDP and HSE where certain laboratory activities can be undertaken within an MSC at containment level 2 (CL2)1.
At key levels, in a diagnostic lab, we would expect
- segregation of lab and public/office areas.
- lab area divided into three zones: 1) Sample receipt/storage, 2) Sample processing & testing and 3) Sample & reagents disposal.
- strict access control for trained &/or authorised personnel only.
- separate route for goods and biomedical waste.
- suitable ventilation; air changes and HEPA (High Efficiency Particulate Air) filtration.
- negative pressure environment.
- PPE (Personal Protection Equipment).
- tested & certified class II MSCs (microbiological safety cabinets).
- autoclaves for deactivating biological waste at high temperature & pressure (with Biomedical Waste disposal Policy and regulatory compliance).
- services for lab equipment, e.g. centrifuges, PCR (Polymerase Chain Reaction) machines, autoclaves, MSCs, fridges, freezers etc.
- SOPs (Standard Operating Procedures).
Due to potential pathogenicity of the samples and importance of speed to control the pandemic, all the critical equipment will need to be on back-up generators or UPS (uninterrupted power supply).
If you are thinking about converting your current facilities (offices or labs) into diagnostic, biomedical or research labs (BSL2 or BSL3) and need advice on their suitability, we can help.
Note: This is only overview guidance and not exhaustive design criteria as the individual lab would need researching in detail before the design.
References:
1. GOV.UK: COVID-19: safe handling and processing for samples in laboratories
2. HSE: The Control of Substances Hazardous to Health Regulations 2002. Approved Code of Practice and guidance
Dr Manisha Kulkarni
Head of Science & Technology
Bulb Laboratories
