Quality at laboratories of the UK Health Security Agency, Colindale
Updated 28 April 2025
© Crown copyright 2025
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/quality-standards-microbiology-services-colindale/quality-at-laboratories-of-the-uk-health-security-agency-colindale
UKHSA Colindale, laboratory quality standards
UKHSA’s role in protecting public health
The UK Health Security Agency (UKHSA) protects the public by using our expert analysis and genetic research capabilities to tackle infectious diseases and other health threats. We manage important scientific facilities at Porton Down and Colindale, allowing us to respond quickly and effectively to:
- terrorist threats to health
- pandemics
- environmental hazards
We coordinate health protection across the entire UK through:
- agreements that help manage pandemics
- the Joint Biosecurity Centre (JBC), which provides intelligence to all UK nations
- partnerships that bring together experts to create coordinated responses
UKHSA Colindale
Our Colindale site houses specialist laboratories and departments that perform many different functions. We are committed to excellence in infectious disease work. We have a policy of getting independent accreditation wherever possible.
The laboratories at Colindale:
- meet all relevant quality standards for their specific work (details in Table 1)
- are accredited to train healthcare scientists through the National School of Healthcare Science (NSHCS)
- are approved by the Institute of Biomedical Science (IBMS) for pre and post registration training
Table 1. Compliance at UKHSA Colindale
| Laboratory or department | Accreditation or certification | Number |
|---|---|---|
| Bacteriology Reference Department (BRD) | UKAS (ISO 15189:2022) | 8197 |
| BRD: Gastrointestinal Bacteria Reference Unit (GBRU) - Foodborne Pathogens Reference Service (FPRS) | UKAS (ISO 17025:2017) | 8197 |
| Virus Reference Department (VRD) | UKAS (ISO 15189:2022) | 8825 |
| Colindale Sequencing Laboratory (CSL) | UKAS (ISO 15189:2022) | 8727 |
| Department of Bioinformatics | UKAS (ISO 15189:2022) | 10742 |
| Food, Water and Environmental Microbiology Services | UKAS (ISO 17025:2017) (multisite) | 1645 |
| National Mycobacterium Reference Service South (NMRS-S) | UKAS (ISO 15189:2022) | 10080 |
| Laboratory Support – Media Services Colindale | ISO 9001:2015 | LRQ00002335 |
| UK National External Quality Assessment Service (NEQAS) for Microbiology | UKAS (ISO 17043:2023) | 4715 |
| Food and Environmental Proficiency Testing Unit (FEPTU) | UKAS (ISO 17043:2010 – ISO 17043:2010 pending award) | 0006 |
| Culture Collections | UKAS (ISO 17025:2017) (multisite) | 8552 |
| National Microbial Biobank | ISO 9001:2015 | LRQ10581638 |
| Standards Unit (Standards for Microbiology Investigations) | ISO 9001:2015 | LRQ0007399 |
The accreditation status of UKAS compliant areas can be viewed on the UKAS website.
The accreditation status of ISO 9001:2015 compliant areas are maintained by LRQA.
Table 2. World Health Organization (WHO) collaborating centre, accredited or national laboratories based at Colindale
| Type of WHO laboratory | Colindale laboratory | Speciality |
|---|---|---|
| Designated collaborating centre | BRD: Antimicrobial Resistance and Hospital Acquired Infections (AMRHAI) | Reference and research on antimicrobial resistance and healthcare associated infections |
| Designated collaborating centre | BRD: Respiratory and Vaccine Preventable Bacteria Reference Unit (RVPBRU) | Haemophilus influenzae and Streptococcus pneumoniae |
| Global Specialised Laboratory | VRD: Antiviral Unit (AVU) | HIV Drug Resistance |
| Global specialised laboratory | VRD: Immunisation and Diagnostic Unit (IDU) | Measles and rubella |
| Polio National Laboratory | VRD: Polio Reference Service (PRS) | Polio |
| National Influenza Centre | VRD: Respiratory Virus Unit (RVU) | Influenza |
| Reference laboratory | VRD: Respiratory Virus Unit (RVU) | Respiratory Syncytial Virus |
| Reference laboratory | VRD: Respiratory Virus Unit (RVU) | SARS-CoV-2 |
| Reference laboratory | VRD: Respiratory Virus Unit (RVU) | MERS coronavirus |
| Reference laboratory | BRD: Respiratory and Vaccine Preventable Bacteria Reference Unit (RVPBRU) | Diphtheria and streptococcal infections |
The UKHSA Colindale quality policy
UKHSA laboratories at Colindale work with partners to protect people from infection. We do this by:
- detecting infectious diseases
- diagnosing infections
- monitoring disease spread
- controlling communicable diseases
The laboratories are committed to providing high-quality services that meet our users’ needs.
Our Colindale site offers a wide range of specialist and reference microbiology tests. You can find details of all our services in our laboratory user manuals.
To meet the needs of our users and stakeholders, our laboratory departments will:
- use quality management systems to identify user needs and allocate appropriate resources
- set and review quality objectives regularly
- maintain effective quality checks on key processes
- continuously improve our services by learning from experience
- apply lessons from improvement programmes across all UKHSA sites
- build quality features into new services
- ensure staff understand our quality policies
- make sure staff follow all relevant procedures
- have backup plans to maintain critical services
- protect confidential information
- uphold professional standards and ethics
- prioritise staff wellbeing and safety
- follow health and safety rules for staff and visitors
- comply with environmental legislation and UKHSA sustainability policies
Each department will comply with standards and regulations appropriate to the work that they do. These include:
- ISO 15189:2012
- ISO 17025:2017
- ISO 9001: 2015
- WHO standards
- the Human Tissue Act
- Joint Code of Practice for Research
- Good Clinical Practice
- Good Distribution Practice
- the In-Vitro Diagnostic Medical Devices Directive/Regulations (or IVDD equivalent GB regulations when published)
We ensure ongoing quality standards by:
- recruiting, training, developing and keeping skilled staff at all levels to deliver effective services
- properly purchasing and maintaining all necessary equipment and resources
- collecting, transporting and handling all specimens to ensure the highest quality testing
- using testing methods that deliver the most accurate results possible
- providing test results that are timely, confidential, accurate and useful for clinical decisions
- regularly checking user satisfaction, conducting internal audits and participating in external quality assessments to continuously improve our services
Review of policy
This quality policy is reviewed annually by individual departments and by the Deputy Director Reference Services and Deputy Director Colindale Site, and National Standards, Quality and Safety.
Changes to this policy document are implemented by the Head of Quality and Governance Lead on behalf of relevant departments and the Deputy Directors after the conclusion of annual management review meetings.
Environmental policy statement
The government’s strategy to a low carbon economy and net zero has seen the introduction of some very challenging carbon reduction targets. These are set out in the “Greening Government Commitment” document. It sets out “the actions that UK government departments and their partner organisations are taking to significantly reduce the impact they have on the environment: reducing the emissions of greenhouse gases, reducing travel, waste, and water usage and making procurement more sustainable.”
To make sure that we meet the challenge of these commitments, UKHSA, as a public body, will embed sustainable development and environmental management into every part of its operations. For full details please see the UKHSA sustainability policy statement.
Compliance with the Human Tissue Act
UKHSA Colindale is licensed by the Human Tissue Authority (HTA; Licence number 12459) to store tissues from deceased people for scheduled purposes. Further information about the HTA can be obtained online.
Getting consent to remove, store and use human tissues for a scheduled purpose is one of the main principles of the Human Tissue Act. UKHSA Colindale receives samples from coroners’ post-mortems or from NHS establishments across the UK and therefore we are not in a position to either seek consent ourselves or have arrangements in place to confirm that the sender has complied with the requirements of the Act.
When tissue samples from deceased people are received at UKHSA Colindale (as are all samples received at this centre) they are retained securely and confidentiality is maintained in compliance with the principles defined in the Information Security Policy. This policy available upon request or to UKHSA users on UKHSA Pulse.
Information about how we protect your personal information and more about our data protection processes can be found in the Department of Health and Social Care Personal Information Charter.
Unless consent has been obtained or the coroner has requested that samples are retained for further testing, samples are disposed of within 3 months of the initial test being performed. It is normal practice for tissue samples from the deceased to be disposed of in the same way that all other clinical samples we receive at the National Infection Service (NIS). However, we will adhere to any specific requirements regarding disposal or returning tissue samples if requested by the sending coroner or pathologist.
Research activity may also take place on the Colindale site under the scope of the HTA licence. Consent for participation in research activities is required along with approval from the NHS Research Ethics Committee for specific research projects. Other activity considered under the licence may take place on site, such as:
- clinical audits
- education
- performance assessments
- public health monitoring
- quality assurance activities
Consent to carry out these activities is only required from the deceased, not the living and therefore these activities will only be carried out on specimens received from the living.
UKHSA Colindale manages a Biobank facility which operates under the HTA site licence and a Research Ethics Committee approval.
Supplementary note on examination of forensic samples from deceased or living people
Laboratories at UKHSA Colindale that conform to the requirements of either ISO 17025 or ISO 15189 are deemed to satisfy the guidance G19:08/2014 Modules in a Forensic Science Process from the International Laboratory Accreditation Cooperation (ILAC), when testing for markers of infection.
Proficiency testing
In order to comply with clause 5.6.3 of ISO 15189:2012, as a supplier of microbiological reference services, below is a statement describing the external quality assessment (EQA), or interlaboratory comparison, activities at UKHSA Colindale Laboratories.
In the majority of cases, formal EQA schemes (or equivalent) are available and used for the tests performed. UKHSA Colindale participates in a number of these schemes, including those organised by UK NEQAS, Quality Control for Molecular Diagnostics (QCMD) and Centers for Disease Control and Prevention (CDC), Atlanta.
We take special steps to ensure quality for our specialised laboratory work at Colindale when formal EQA schemes don’t exist. In these cases, we:
- use alternative monitoring methods including internal quality control and assessment
- set up informal sample exchange arrangements with international laboratories doing similar work
- share and test strains and reference materials to check our testing capabilities
Our department heads review all proficiency test results, investigate any discrepancies, and use this information to continuously improve our quality standards. We also regularly conduct internal audits to check compliance with our quality procedures and review these findings at management meetings.
For information regarding EQA activities for specific tests please contact the departments directly. Contact details are available on the health protection services pages.
Turnaround times
As a supplier of microbiology reference testing facilities, turnaround times are published on the individual department pages on the GOV.UK website within the user manuals.
Details of these pages on websites are listed in Table 3.
Published turnaround times may vary according to the complexity of the investigations required.
Table 3. Laboratory or department turnaround times
| Laboratory or department | Information on turnaround times |
|---|---|
| Bacteriology Reference Department | Guidance overview: Bacteriology reference department user manual |
| Virus Reference Department | Guidance overview: Virus reference department (VRD) user manual |
| National Mycobacterium Reference Service South | National mycobacterium reference service South user handbook |
Compliance with TPS 53 and the use of UKAS accreditation symbols
When a Colindale laboratory is certified to ISO 17025 or ISO 15189, then it shall, in line with TPS 53, use only the words below when referring to the laboratory or inspection body quality management system on test or examination reports and certificates:
Statement on test reports and calibration certificates (ISO 17025)
“This laboratory is accredited in accordance with the recognised International Standard ISO/IEC 17025. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (from the joint ISO-ILAC-IAF communiqué dated April 2017).”
Statement on medical test or examination reports (ISO 15189)
“This laboratory is accredited in accordance with the recognised International Standard ISO 15189:2012. This accreditation demonstrates technical competence for a defined scope and the operation of a medical laboratory quality management system (from the joint ISO-ILAC-IAF communiqué dated January 2015).”
Any use of the UKAS national accreditation symbol by Colindale UKHSA laboratories shall be in compliance with the department of Business, Energy and Industry Strategy guidance document on accreditation logo and symbols.
Additional information
This page is the HTML version of document QW0080.27 ‘Quality at the laboratories of UK Health Security Agency, Colindale’. It replaces the previously issued version with updated branding and the removal of accreditation certificates.
For queries relating to this document, please contact Anna.Garrido@ukhsa.gov.uk