Memorandum 18
Submission from the Health Protection
Agency
EXECUTIVE SUMMARY
1. The Health Protection Agency is responsible
for most of the ACDP Category IV laboratories in the UK, along
with a large number of ACDP Category III laboratories. These laboratories,
the National Collection of Type Cultures and the National Collection
of Pathogenic Viruses contain all the microorganisms (with the
exception of variola) listed in Schedule 5 of the Anti-terrorism,
Crime and Security Act 2001 Part 7—Security of Pathogens
and Toxins (ATCSA 2001). Work with these organisms contribute
to the Agency's remit in public health, including its role in
counter-terrorism and its contributions to global public health.
All of the laboratories in its major research
centres have been recently audited by the National Counter Terrorism
Security Office (NaCTSO) and no substantially issues have been
identified. In addition, most of the regional laboratories which
house Schedule 5 microorganisms have been audited by NaCTSO and
there is an active dialogue about future registration between
the remaining laboratories and NaCTSO.
All staff which work in high containment laboratories
receive extensive training and those which work in ACDP Category
IV laboratories undergo security screening.
BACKGROUND INFORMATION
2. The Health Protection Agency is an independent
expert organisation established by Parliament in 2003 to protect
people from hazards to health, including infections, chemicals
or radiation. From 2009 the HPA will also incorporate the standards
and biological control functions of the National Biological Standards
Board.
The Agency develops science into sound evidence
and advice and provides leadership to ensure that our advice is
turned into practice. It also provides a full range of medical,
scientific and technical services in support of our health protection
role.
The Agency aims to:
— provide independent evidence-based
expert advice without bias or prejudice;
— act on sound evidence and translate
science into new ways of protecting the population—being
measured by our impact on public health;
— widen the public health base by working
with and training others;
— provide a trusted effective interface
with Government, other health organisations and the public—including
vulnerable disadvantaged groups thus helping to reduce inequalities;
and
— set health protection standards for
ourselves and others to employ.
FACILITIES FOR
HANDLING AND
STORING PATHOGENIC
MICROORGANISMS
3. The Agency has two major research centres
which handle and store microorganisms which are pathogenic for
humans. The Centre for Emergency Preparedness and Response (CEPR)
is located on Porton Down, near Salisbury in Wiltshire and the
Centre for Infections (CfI) is in Colindale on the North Western
outskirts of London. The Agency's third research centre, the Centre
for Radiation, Chemicals and the Environment (CRCE) at Chilton
in Oxfordshire does not handle any microorganisms. In addition
the Agency provides Local and Regional microbiology services (LARS)
organised into 30 Health Protection Units (HPUs) and a Regional
Microbiology Network (RMN) of 8 laboratories and 37 collaborating
laboratories. The roles of LARS and RMN are summarized in Annex
A.
4. The Centre for Emergency Preparedness
and Response
CEPR has 35 ACDP Category III laboratories covering
almost 850 square metres. These laboratories enable work with
pathogenic organisms in culture and also small experimental animals,
including non-human primates. It also has two ACDP Category IV
laboratories covering an area of almost 60 square metres, for
working with pathogens in culture using sealed "cabinet lines",
and six ACDP Category IV laboratories covering about 150 square
metres for work with small experimental animals, including non-human
primates. The ACDP category IV laboratories and many of the ACDP
Category III laboratories were built over 50 years ago and refurbishment
and upgrading work is becoming increasing difficult. Consequently
the HPA has begun discussions with DH about the long term strategic
redevelopment of the Porton site which will involve the construction
of new high containment laboratories. In addition, the Agency
has commenced, in conjunction with the MRC, a national review
of ACDP category IV and SAPO category IV laboratory facilities
within the UK.
5. The Centre for Infections
CfI houses 14 ACDP Category III laboratories
covering over 450 square metres and one ACDP Category IV laboratory
covering almost 65 square metres. These laboratories are suitable
for working with cultured microorganisms only.
6. Regional Microbiology Network
There are eight Regional microbiology laboratories,
some of which handle and/or store schedule 5 organisms. Details
of the work of these laboratories can be found in Annex A.
HAZARDOUS ORGANISMS
HANDLED AND
STORED IN
HPA LABORATORIES
7. CEPR, CFI and the NaCTSO-compliant regional
laboratories handle and store a wide variety of Schedule 5 organisms
and further details can be supplied if the Committee wishes. Several,
but not all RMN and LARS laboratories handle or store Schedule
5 pathogens and further details can also be supplied if the Committee
wishes.
8. National Collection of Type Cultures
The National Collection of Type Cultures (NCTC)
supplies reference bacterial cultures of medical, scientific and
veterinary importance world-wide to support academic, health,
food and veterinary institutions. The collection (which is certified
to BS EN ISO 9001:2000) comprises over 5000 bacterial cultures,
together with over 100 mycoplasmas and more than 500 plasmids,
host strains, bacteriophages and transposons.
Situated at the Health Protection Agency's Centre
for Infections at Colindale (formerly Central Public Health Laboratory),
NCTC has ready access to the wide-ranging expertise of an internationally-renowned
body of specialists in clinical and environmental microbiology.
These experts check each new batch produced by NCTC, ensuring
quality control second to none.
Whilst the collection is maintained and supplied
in traditional glass ampoules, some cultures are available as
more user-friendly LENTICULE discs, in both qualitative and quantitative
formats.
In addition to the supply of bacterial cultures,
NCTC also provides a range of associated services, which include:
1. Freeze-drying of customers' own strains.
2. International Depository Authority (IDA)
patent depository for bacterial cultures.
3. Production of cultures and samples for
use in EQA schemes.
4. Provision of cultures in LENTICULE disc
format.
Founded in 1920, NCTC is the longest-established
collection in the world offering a bacterial culture supply service.
It is recognised internationally, serving as a European Resource
Centre for Plasmids and a United Nations Educational, Scientific
and Cultural Organization (UNESCO) Microbial Resource Centre (MIRCEN).
It also holds and supplies some of the more popular cultures of
the National Collection of Pathogenic Fungi (NCPF).
9. National Collection of Pathogenic Viruses
The National Collection of Pathogenic Viruses
(NCPV) preserves well-characterised, authenticated human pathogenic
viruses in a secure facility. The agents or nucleic acids derived
from these viruses are supplied to the scientific community according
to national and international guidelines. The Collection is primarily
comprised of human pathogenic viruses requiring handling at biosafety
levels 3 or 4, but has expanded to encompass hazard group 2 pathogens.
Most of the material is in the form of cell-cultured virus stocks,
but provision has also been made (where desirable or necessary)
for selected clinical material and uncultivable viruses to be
archived as serum, tissue or other biological samples, or in the
form of cloned material. The Collection contains materials which
are not readily available to the wider scientific community, particularly
in the area of emerging virus diseases. We expect the Collection
to be of benefit in the future development and testing of vaccines
and antiviral compounds, in the development and validation of
diagnostic test systems, and in the conservation of biodiversity.
AUDIT BY
NACTSO
10. Both CFI and CEPR, including NCTC and
NCPV, have been audited by NaCTSO and no significant issues were
identified on either site.
Three RMN laboratories are already registered
with NaCTSO. Where registered, RMN laboratories are in ongoing
dialogue with local Counter Terrorist Security Advisors (CTSAs)
in order to ensure compliance with the 2001 act and subsequent
guidance. Most other RMN laboratories do not have to register
with the Home Office due to the "diagnostic specimen"
exclusion (para 2 (3)(c)(i+ii)2002 SI No.1281). Although not Home
Office registered, many HPA RMN labs still have regular CTSA visits
as a proactive initiative by NaCTSO and local CTSAs. These have
proved beneficial with positive feedback from the laboratory managers
on advice they have received. RMN laboratories regularly review
any schedule 5 organisms kept for legal reasons to ensure we are
registered appropriately for these. Some food, water and environment
laboratories have to retain stocks of organisms such as E. coli
0157 and C.perfringens until any prosecutions by local authorities
have taken place. Steps are being taken to register these laboratories
where appropriate. Some RMN laboratories have historical stocks
of schedule 5 organisms retained for research purposes (eg: C.perfringens
stored at the Cambridge-based HPA laboratory). Discussions, based
on scientific value, are taking place on whether to destroy or
register stocks. The CfI Mycology Reference Unit (MRU) embedded
in the RMN Bristol laboratory has stocks of the fungi Cladophialophora
bantiana and Cryptococcus neoformans. CTSAs already regularly
visit and advise the MRU which has resulted in various upgrades
to security. Steps are underway to register this laboratory with
the Home Office.
TRAINING AND
SCREENING OF
STAFF
11. All staff working in any laboratory
handling or storing human pathogens receive extensive training
at the appropriate level. In addition, the HPA trains staff from
other organizations in the handling and storage of human pathogens.
Details of these training programmes can be provided if requested.
All staff working in ACDP category IV laboratories
undergo security checks at SC level. The backgrounds of staff
in other laboratories are checked as for all government employees,
upon appointment.
TRANSPORT OF
HAZARDOUS MICROORGANISMS
12. In April 2005, the Health Protection
Agency Executive Group mandated an HPA stakeholder group to alert
the HPA and HPA Collaborating Laboratories to changes in the transport
regulations for infectious substances, and to draft best practice
guidance. A guidance document "Interim Guidelines on infectious
substance transfers at HPA and HPA Collaborating Laboratories,
2005", was distributed by HPA Local and Regional Services.
(Copies can be provided if required). This was produced in conjunction
with Dr Tony Phillips, a former senior member of staff at the
Dstl laboratories at Porton Down.
These regulations, The Carriage of Dangerous
Goods and Use of Transportable Equipment (Amendment) Regulations
2005, entered into force on 22 July 2005, but the Department of
Health obtained a derogation for mycobacterium tuberculosis, E.
coli 0157 and Shigella dysenteriae to be transported as Schedule
B organisms within the UK. Dr. Robert Spencer from the HPA sits
on the UN Sub Committee of Experts on the Transport of Dangerous
Goods and on the Globally Harmonised System of Classification
and Labelling of Chemicals.
January 2008
Annex A
LOCAL AND REGIONAL SERVICES (LARS)
THE ROLE
OF LARS
The LARS Division of HPA was created in 2003
by bringing together the PHLS Regional Laboratories and approximately
100 local and nine regional NHS communicable disease control teams,
many with single handed senior members of staff. During the first
two years the Division moved towards the provision of an integrated,
coherent and consistent national health protection service delivered
through front line services in partnership with the NHS, Local
Authorities and other agencies across the range of HPA responsibilities
and not just communicable disease control. In order to ensure
resilience, to provide critical mass for the wider range of health
protection threats dealt with by the HPA, and to enable a balanced
mix of skills in teams, some 100 small local teams were amalgamated
into 30 (as of October 2006) larger Health Protection Units (HPUs).
In 2005, the HPA Board agreed a series of proposals
to further strengthen its frontline services. The "Strengthening
the Frontline" policy recognised that the core functions
are to be provided by expert multidisciplinary teams, local enough
to be sensitive to the needs of communities, but large enough
to sustain the expertise and capacity to respond to the full range
of health protection threats.
The policy required a shift of resource to front
line Health Protection Units. and that the LARS division is divided
into "LARS laboratories" and "LARS Health Protection
Units", each with an Executive Director. The creation of
two new front line divisions took place in 2006. HPU Heads report
to Regional Directors who in turn report to the Director of LARS.
The management of the Health Protection Units is now through an
executive made up of the regional directors and the LARS director.
A common approach is being implemented within regions with each
having an executive team made up of the Regional Director and
heads of HPUs who will take responsibility for deployment of all
regional resources.
MAPPING HPU FUNCTIONS
In parallel with "Strengthening the Front
Line" in 2005, the Health Protection Agency developed a project
to map the activities of its local health protection units. To
do this a categorisation of health protection was devised:
Communicable Disease threats
— Health care acquired infection and
antibiotic resistance.
— Vaccine preventable diseases.
— Gastrointestinal including food and
waterborne.
— Respiratory and other systemic infections
including tuberculosis.
— Zoonoses and other emerging infections.
— Sexually transmitted and blood borne
infections.
Allergens
including chemicals, moulds, plant and food allergens,
house dust mites.
Chemicals and Poisons
— Chemicals in waste, water, air, food.
Radiation
— Low and high dose ionising radiation.
— Non ionising radiation.
Extreme Events
— Weather (eg winter and summer mortality).
— Disasters (eg flooding, bombings
etc).
Psychological threats
(eg psychogenic incidents, terror and the fear
of health effects from exposures).
Wider Public Health Issues
— Neighbourhoods and incivilities.
A hierarchy of activity was described, moving
from the science base through surveillance, risk assessment to
advisory leadership and management.
In 2006, Health Protection Units assessed their
activity within these sub-domains. There was considerable variation
between units, explained partly by epidemiology such as higher
rates of Tuberculosis in inner cities or distribution of chemical
hazards from industrial sites around the country, but mainly it
was explained by the way in which the local units were created
at the inception of the HPA. In some parts of the country infection
control staff came into the HPA bringing their work, and in other
parts this did not happen to the same extent.
In order to develop a specification for the
functions and outputs of Health Protection Units, not only the
sub domains but the roles, responsibilities and functions and
outputs of Health Protection Units needed to be spelled out in
relation to the work of other parts of the HPA and other partners
in Health protection. To do this, a number of scenarios were developed.
The scenario work has exposed the facts that there are areas of
activity where clear governance and assurance systems need strengthening.
A particular issue was how the HPA Centres were linked to LARS
in managing incidents, and what are the lines of accountability.
This has been addressed in the new HPA Incident Plan.
Moving on from the review of current HPU functions,
this business plan includes objectives to define the HPU of the
future and the processes and systems that must be developed.
REGIONAL MICROBIOLOGY
NETWORKS (RMN)
The Regional Microbiology Network (RMN) was
established as a Division of the Health Protection Agency in April
2006. The RMN is composed of eight Regional Microbiology Laboratories
and 37 Collaborating Laboratories. These Laboratories provide
frontline diagnostic and public health microbiology services to
NHS Trusts and HPA Health Protection Units. There are 26 Food,
Water and Environmental (FW&E) Laboratories of which nine
are directly managed by the HPA and 17 are located in Collaborating
Laboratories in NHS Trusts.
The vision for the RMN is "To create an
effective and efficient modernised HPA Microbiology Laboratory
Network capable of addressing present and future challenges".
This will address the main health protection functions outlined
in the Chief Medical Officers strategy for combating infectious
diseases "Getting ahead of the curve". The Network needs
to be robust with strong links to the wider microbiology community
to share expertise, capability and capacity. Such a network partnership
will enable the HPA to be proactive, flexible, resilient and responsive
to future needs and developments in health protection in the UK.
A key relationship for the RMN is to continue to work seamlessly
with the Local and Regional Services Division to produce the essential
data to support frontline health protection activities locally,
regionally and nationally. Working in partnership with the Centre
for Infections (CfI) will provide the RMN and the HPA with opportunities
to improve the responsiveness of diagnostic services to local
public health and clinical needs. An example of this is the H5N1,
regional capability for not only a rapid local diagnostic service
but also the ability to affect rapid public health interventions.
There are several challenges facing the RMN
not least the recent changes in the NHS and in particular the
Department of Health "Modernisation of Pathology" programme.
The HPA is committed to supporting the programme but must ensure
in so doing it secures the outputs needed to deliver its functions.
The Carter Report of the Review of NHS Pathology Services is likely
to have far-reaching effects on the way in which pathology services
in England are configured and delivered. The report identifies
changes which will have implications relating to surveillance
and not least laboratories. The main risk for future health protection
laboratories is that the recommendation of increased plurality
of providers, including the private sector, could affect the current
flow of information, isolates and samples. However, the RMN together
with the CfI has developed service specifications and commissioning
arrangements. In addition, the HPA is actively involved in influencing
the development of future services and ensuring that health protection
functions are a core component of pathology services.
A major task for 2007-08 for the new RMN Division
is developing all the relevant frameworks essential to underpin
the necessary activities to deliver a well managed and coordinated
Division. These include corporate and clinical governance, frameworks
for health and safety, risk management, business support, finance
and human resources.
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