Guidance

Quality at laboratories of the UK Health Security Agency, Colindale

Updated 3 April 2019

UKHSA Colindale, laboratory quality standards

The UK Health Security Agency (UKHSA) was established on 1 April 2021. We will coordinate across the UK, building strong collaborations with public health agencies for Scotland, Wales, and Northern Ireland, and will operate internationally for the UK to help understand, prevent, and respond to global threats to health.

We will prevent threats by deploying the full weight of our analytic and genomic capability, on infectious diseases and beyond, and will hold responsibility for our health security scientific capabilities including those at Porton Down and Colindale. It will respond to the threats we face with speed and scale, including terrorist threats to health, another pandemic or environmental hazards.

We will encompass existing UK-wide activities, including operational agreements supporting pandemic management, the whole-UK role of the Joint Biosecurity Centre (JBC) as a shared intelligence resource, and a wide range of domestic collaborative activity to pool expertise and coordinate responses.

UKHSA Colindale contains a number of laboratories and departments of the Specialist Microbiology and Laboratories Directorate with a wide range of functions. The agency prides itself on being a centre of professional excellence with an unsurpassed reputation in the field of infectious diseases. In order to support this, it is our policy to obtain accreditation or certification through third party assessment where applicable.

Laboratories in UKHSA Colindale fully comply with a wide range of accreditation or certification standards appropriate to the function of the department (see Table 1).

Table 1. Compliance at UKHSA Colindale

Laboratory or department	Accreditation or certification	Number
Bacteriology Reference Department (BRD)	UKAS (ISO 15189:2012)	8197
BRD: GBRU-FPRS (Foodborne Pathogens Reference Service)	UKAS (ISO 17025:2017)	8197
Virus Reference Department (VRD)	UKAS (ISO 15189:2012)	8825
Central Sequencing Laboratory (CSL)	UKAS (ISO 15189:2012)	8727
Bioinformatics	UKAS (ISO 15189:2012)	10742
London Food Water and Environmental Microbiology Laboratory	UKAS (ISO 17025:2017)	1645
National Mycobacterium Reference Service South (NMRS-S)	UKAS (ISO 15189:2012)	10080
Laboratory Support – Media Services Colindale	ISO 9001:2015	LRQ00002335
UK National External Quality Assessment Service (NEQAS) for Microbiology	UKAS (ISO 10743:2010)	4715
Food and Environmental Proficiency Testing Unit (FEPTU)	UKAS (ISO 10743:2010)	0006
UK NEQAS European Collection of Cultures and Authenticated Cell Cultures (ECCACC) and National Collection of Type Cultures (NCTC)	UKAS (ISO 17025:2017)	8552
Standards Unit (Standards for Microbiology Investigations)	ISO 9001:2015 NICE accreditation	0007399 -

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
Reference laboratory	BRD: Respiratory and Vaccine Preventable Bacteria Reference Unit (RVPBRU)	Diphtheria and streptococcal infections
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	Influenza
Reference laboratory	VRD: Respiratory Virus Unit	Respiratory syncytial virus
Reference laboratory	VRD: Respiratory Virus Unit	SARS-CoV-2
Reference laboratory	VRD: Respiratory Virus Unit	MERS coronavirus

Quality policy

UKHSA’s laboratories on the Colindale site, working in partnership with others, protect the population from infection by detecting, diagnosing, monitoring and controlling communicable diseases. The laboratories are committed to providing services of the highest quality and endeavour to be aware of, and take into consideration, the needs and requirements of service users. UKHSA’s laboratories at Colindale undertake a wide range of specialist and reference microbiology investigations. Full details of the services provided are published in laboratory user manuals.

To ensure that the needs and requirements of users and other stakeholders are met, individual departments and units within UKHSA’s laboratories at Colindale will:

• operate quality management systems that determine the needs and expectations of users and determine the processes, responsibilities and resources necessary to attain the quality objectives
• set and keep under review quality objectives and plans to implement the quality objectives of UKHSA’s laboratories at Colindale
• maintain effective quality assurance procedures to ensure that the quality of our services is achieved and maintained through control of key processes
• employ a process of continual quality improvement: this includes corrective action, preventive action and improvement processes – any lessons learnt through the improvement programmes at Colindale or other UKHSA sites will be integrated into the training and education of staff
• incorporate quality features during development of new services
• ensure that staff understand the requirements of this quality policy and relevant quality objectives
• ensure that staff are familiar with, and work to, all procedures relevant to their work
• implement business continuity procedures to facilitate and maintain critical service delivery
• comply with the UKHSA’s information governance policies to protect confidentiality and ensure the integrity and availability of data
• uphold professional values and be committed to good professional practice and conduct, including maintaining confidentiality, considering ethical requirements and avoiding conflicts of interest
• commit to the health, safety, and wellbeing of staff
• apply UKHSA’s health and safety policies and procedures for the benefit of staff and visitors, in accordance with legislative requirements
• conform to UKHSA’s environmental and sustainability policies, which include the commitment to comply with relevant environmental legislation

Individual departments will comply with standards and regulations appropriate to the nature of the work undertaken, including 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, and the In-Vitro Diagnostic Medical Devices Directive/Regulations (or IVDD equivalent GB regulations when published). To achieve continued compliance, departments and units are committed to quality, including but not limited to:

• staff recruitment, training, development, and retention at all levels to provide a full and effective service to its users
• the proper procurement and maintenance of such equipment and other resources as are needed for the provision of the service
• the collection, transport, and handling of all specimens in such a way as to ensure the highest achievable quality of all tests performed
• the use of examination procedures that will ensure the highest achievable quality of all tests performed
• reporting results of examinations in ways which are timely, confidential, accurate and clinically useful
• the assessment of user satisfaction, in addition to internal audit and external quality assessment where appropriate, in order to produce continual quality improvement

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

UKHSA recognises the important link between the UN’s Sustainable Development Goals, and the associated health and environmental impacts on our society, now and in the future from climate change. To help mitigate this risk, we will develop all our sustainable assets – environmentally, economically, and socially. Achieving our objectives in a sustainable and low carbon way is critical to the collective improvement that is needed in meeting the requirements set out in this policy and our strategy document, the Sustainable Development Management Plan (SDMP).

By implementing and embedding our sustainable development strategy we will endeavour to continually improve our environmental performance, whilst progressively reducing our overall environmental impact. We will:

• ensure compliance with all relevant UK government environmental policies, legislation, and guidance
• ensure that sustainability is considered in all UKHSA policy decisions
• identify, assess, and manage environmental risks to our staff, and others, affected by our activities
• advocate the health co-benefits of a sustainable healthcare system by providing scientific expertise, leadership, and guidance to our stakeholders
• focus on the way we do business, including our role in coordinating science, policy, actions, and advocacy in this area
• undertake environmental compliance audits to ensure the organisation is meeting its legal and environmental management obligations
• reduce our carbon impact in line with the governments and our own Net Zero Carbon agenda, developing and implementing strategies for water, waste, energy, transport, and procurement, where appropriate
• put control measures in place to prevent pollution from our owned estate
• assess and include sustainable options for all new and refurbished developments as an integral part of our estate’s strategy
• expect our suppliers and contractors to demonstrate a high standard of environmental performance and social value
• ensure continual improvement of our environmental performance, through the implementation of a dedicated Environmental Management System, and our SDMP
• allocate reasonable resources to support this policy

Compliance with the Human Tissue Act

Submitting tissue samples from deceased people

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.

Obtaining consent to remove, store and use human tissues for a scheduled purpose is one of the underlying principles of the Human Tissue Act. UKHSA Colindale receives post-mortem 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 requirements of the Act have been complied with by the sender.

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, 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.

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.

Due to the specialised nature of the laboratory work carried out at Colindale, occasionally formal EQA schemes may not be available. In this situation the quality of results are assured using alternative performance monitoring activities (internal quality control and internal quality assessment) and where possible informal sample exchange schemes are established by collaborating with international laboratories performing similar functions. Strains and reference materials are exchanged and tested to challenge the performance of our testing facilities.

Results of proficiency tests are reported to the heads of department, discrepancies are investigated, and the results are used to support our commitment to continuous quality improvement. Internal quality system audits of compliance with documented quality-related procedures are carried out within departments. The audit findings are reviewed regularly at management meetings.

For information regarding EQA activities for specific tests please contact the departments directly. Contact details are available on the services pages.

Turnaround times

Turnaround times are published on the individual department pages on GOV.UK, which 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
Central Sequencing Laboratory	Central Sequencing Laboratory 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 (refer 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 (refer 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, Accreditation Logo and Symbols.

Additional information

This page is the HTML version of document QW0080.26 ‘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 [email protected]