ECMC Secretariat Team Meeting - Leeds Teaching Hospitals NHS

Transcription

Experimental Cancer Medicine Centre (ECMC)
Early Phase and Translational Research Nurse
Network Group:
Sample Handling Guidance Document
for Research Nurses and Junior Clinical
Laboratory Staff
Version 1 – March 2011
Authors:
Pam Baxter, R&D Manager, NHS Devon PCT
Anne Croudass, CR-UK Lead Research Nurse
Linda Jones, Senior Research Nurse, Cambridge ECMC and Chair of ECMC
Early Phase and Translational Research Nurse Network
Diana Ribeiro, ECMC Secretariat
Contributing authors:
Dr Jeff Cummings, Staff Scientist, Manchester ECMC
Ruth Boyd, CR-UK Senior Research Nurse, Belfast ECMC
Professor Peter Collins, Head of Molecular Histopathology, Cambridge ECMC
Dr Tim Ward, Staff Scientist, Manchester ECMC
Lesley Bruce, Research Manager, Sheffield ECMC
Marie-Claire Rickard, Quality Assurance Manager, Barts ECMC
Acknowledgments to:
Professor Roz Banks, Leeds ECMC
Heather Biggs, Cambridge ECMC
Elizabeth Folkerd, The Royal Marsden Hospital
Dr Rebecca Gallagher, Belfast ECMC
Lynn Hope, Manchester ECMC
Praradchaya Lamb, ICR ECMC
Dr Paul Loadman, Leeds ECMC
Alex MacLellan, Edinburgh ECMC
Donna-Michelle Smith, Cambridge ECMC
Richard Sugar, CR-UK
Cathy Warner, Cambridge ECMC
Contents
1.
The principles of sample handling and general guidance: Introduction, background
and aims
1
1.1 Reference
2
Sample handling – key processes
3
2.1 Regulatory factors
3
2.2 Feasibility – the study set-up phase
5
Sample preparation
6
3.1 Research nurses and laboratory teams
6
3.2 Important factors to comply with
7
3.3 Important factors from the laboratory perspective
7
Sample management - safe handling
9
4.1 General safe handling of samples
9
4.2 Health & Safety Executive
9
4.3 PPE
9
4.4 Important health and safety issues to consider
10
Sample management – sample processing
11
5.1 Important issues for the safe handling of samples
11
6.
Coding, tracking and quality assurance
12
7.
Transportation and Storage
13
8
Data collection
14
9
Summary and conclusion
15
9.1 Summary and general guidance from laboratory perspective
15
9.2 Conclusion
15
10
Flowchart for nurses
17
11
Flowchart for laboratory staff
18
12
Sample checklist for nurses
19
13
General checklist for laboratory staff
24
13.1 Laboratory case study
24
13.2 References
24
2.
3.
4.
5.
Appendices
25
1
25
Risk Assessment
1.1 What is risk assessment?
25
1.2 PPE
27
1.3 RIDDOR
29
2
COSSH and Example COSHH Assessment
31
3
MHRA Good Clinical Practice for Clinical Laboratories - Glossary
35
4
Data Protection Act
39
5
IATA Dangerous Goods Regulations & Infectious Substances
40
6
Useful websites and contact details
43
7
6.1 ECMC website
43
6.2 The Human Tissue Authority
43
6.3 The Health and Safety Executive
43
6.4 The MHRA
44
6.5 The National Patient Safety Agency
45
Glossary List
46
1. The principles of sample handling and general guidance
Introduction
The Experimental Cancer Medicine Centre (ECMC) Research Nurse Steering
Committee was initially established to support nurses working in early phase and
translational clinical research. As the group has developed it has increased the training
and educational support offered to nurses; which now extends to incorporate our clinical
laboratory partners and quality analysis teams. By working together, the ECMC Network
Group’s remit is to address areas of unmet need, in specific training for research staff in
these roles. To seek further information on ECMC Network groups, please refer to
Appendix 6. The document provides generalised information for junior levels of nursing
and laboratory staff and to those new to skills of sample collection and handling. It is
understood that the document provides general guidance only on some key regulations
and that an element of responsibility is required by the user. Some areas may appear not
to be covered extensively; for example information sheets and consent. This is because
issues involving informed consent are complex, project-specific and warrant further
investigation.
Background
From the success of previous training sessions, involving the expertise of our Research
Nurses, Laboratory and Operational colleagues, it was identified that there was a real
need to provide an informative document in the area of sample collection and handling.
The document identifies key themes to assist both nursing and laboratory staff new to
the complexities of sampling in experimental research. Equally, it can be used as a
reference guide for nurses and junior laboratory staff already involved in this area.
Understanding the importance of patient sample collection from both the nurse and
laboratory perspective are explained within the document. It forms a cohesive approach
to encourage research nurses to work positively and collaboratively with our clinical
laboratory colleagues and quality assurance staff, towards effective and accurate biological
research sample and specimen collections.
For example in a recent quality survey, the National Academy of Clinical Biochemistry
Laboratory Medicine (in the USA), reported that “the majority of pre-analytical errors for
tumour markers are attributable to simple specimen-handling errors, such as
inappropriate timing and incorrect specimen identification…the occurrence of which
should be minimized by good laboratory practice and effective auditing procedures”1
Sample Handling Guidance Document – Version 1 March 2011
1
Aims
The document aims to explain what needs to be done and when, along with the
importance of both nurse and laboratory staff roles, in the sample collection and handling
process. It provides staff with the general overview detail, a checklist, flowchart and
regulatory appendices. The document will be regularly reviewed and updated and it
highlights to the nurse or laboratory staff that the way in which every sample is…
-
collected, handled, labelled, prepared, processed and transported
And how a sample is…
-
coded, recorded, data logged, stored and subsequently analysed
…ultimately has a direct impact on the overall success of the study.
The document includes references of institutional, regulatory and custodial arrangements
for sample collection, plus the recording, monitoring and storage of samples to meet the
requirements of good clinical practice (GCP). The identity, quality and integrity of the
sample for its given lifetime must be assured by all parties involved in the sample process.
In general, the statutory responsibility rests with the employing authority to protect staff
from any occupational hazards that they may be exposed to in the course of their duties.
For example, signs and emergency lighting showing where fire exits are and the use of
yellow warning cones when floors are wet and slippery. However, sample handling and
processing may expose the handler to a multitude of different risks that may be very
specific to a particular type of study, or process; most are minor, although some may
pose a more significant risk. These risks can range from biohazards when handling blood,
serum or plasma, to radiation risks when assisting in specific techniques using radioactive
markers, or gamma radiation used in research investigating sentinel node biopsies. It is
important to check that risk assessments are undertaken, the required safety measures
are honoured and that any training required has been undertaken by any persons
involved in the sample management process.
Please refer to the document as a general guide. It is provided as a tool to promote and
encourage further exploration and more detailed investigation by the user through
accessing the references and web links provided later within the document.
1.1
1.
Reference
Sturgeon, C. M., Hoffman, B. R., Chan, D. W., Ch'ng, S. L., Hammond, E., Hayes, D. F., Liotta, L. A., Petricoin, E. F., Schmitt,
M., Semmes, O. J., Soletormos, G., van der Merwe, E., and Diamandis, E. P. National Academy of Clinical Biochemistry
Laboratory Medicine Practice Guideline for use of tumor markers in clinical practice: quality requirements. Clin Chem, 54:
e1-e10, 2008
2
2. Sample handling: – key processes
2.1
Regulatory factors involved in sample handling
Many factors influence sample collection and handling; all are important and adherence
to the regulations is mandatory. In simple terms, the collection and labelling of a specific
sample can be likened to the same principles used in registering a car. Each sample
collected needs a unique identifier much like a car is assigned a registration plate when
new. With a car, the registration document allows you to track where it is kept, how old
it is and who owns it. Similarly, it is important to track where and when a sample was
collected, who is the custodian of it (owner), where it is stored; plus what happens from
collection through to the point of sample disposal. It is as relevant as the car registration
process.
When a sample is moved from one freezer storage to another, or collected, frozen and
shipped to another facility; it is important to be able to track the sample from start to
finish. By recording and keeping an accurate data log for each sample by using relevant
unique identifiers, date and time, it is possible to prove ownership and validity of any
sample. The details identifying all samples are required by the competent regulatory
authorities e.g. the Medicines and Healthcare products Regulatory Agency (MHRA)
when a research facility is inspected.
External and internal regulatory factors categories are divided as so;
1. Regulatory factors by competent authorities:
External – The National Research Ethics Service (NRES); MHRA; Human Tissue
Authority (HTA)
Internal - National Health Service (NHS) Research & Development (R&D) Trust
Approvals plus; International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH)/GCP &
Good Clinical Laboratory Practice (GCLP)
2. Guidance specific to each study:
External & Internal - Protocols, Study Lab Manual, study-specific Standard
Operating Procedures (SOP’s), Investigator Brochures, Sponsor and Clinical Trials
Agreements, any Material Transfer Agreements
3. Health and Safety Executive regulated processes:
External & Internal - Risk Assessments, Control of Substances Hazardous to
Health (COSHH), Reporting of Injuries, Diseases and Dangerous Occurrences
Regulations (RIDDOR), Material Data Safety Sheets
4. Internal policies and procedures:
Internal - NHS policies/procedures that must be complied with to ensure duty of
care, accountability and Medical Laboratory Standards and policies for quality
assurance and regulation
3
The identity of a sample and maintenance of its integrity from collection to the point of
analysis and point of disposal cannot be overemphasised. Therefore, the essential factors
to enable the sample to be of research value are:
•
•
Clear-cut labelling and use of the correct type of collection vessel for the
sample being collected
Use of correct equipment and facilities required for processing, storage,
analysis and disposal
And
•
Good communication and established links between the trials centre/
associated clinical staff and the laboratory
Evidence of a satisfactory level of competence to meet the appropriate standards for
inspection by regulatory authorities is required for any samples collected. All research
nurses and junior laboratory staff members involved in any type of sample collection for
research purposes should undertake training in, and comply with, MHRA GCP guidelines;
GCP the quality standard for the analysis of clinical trial samples, which incorporates the
principles of GCLP, otherwise referred to GCP(L) or GCPClinLab by the regulatory
authorities.
The aim in sample collection for both nursing and laboratory staff is to contribute
significantly in assisting the clinical investigators to obtain reliable results in early phase
and translational research studies. Although the Chief Investigator takes ultimate
responsibility for any trial or study undertaken, the teams involved in sample collection
should ensure that any sample collected can be accounted for, traced and subsequently
audited.
Therefore, associated staff must be well organised and receive any necessary training
prior to any sample collection commencing. The details of specific training undertaken for
a particular study should be recorded in the appropriate delegation log. All nursing and
laboratory staff have a personal responsibility to maintain their own training record as
part of their Personal Development Plan/Record.
The type of sample, how it is to be collected, processed and stored, will determine
which staff groups may be involved in supporting the study. Examples of the groups of
staff that may be involved and sample types are provided as a general guide:
•
•
•
Ward or clinic staff – blood or urine samples
Theatre staff – tissue samples/all types
Radiology/Imaging teams – intra-operative gamma radiation detection of samples
and intestinal tract samples, from brushings, secretions or suction traps
• Biochemistry and or Haematology clinical laboratory staff – a variety of
specialised sample processes
• Pathology specialist and scientific officers – tumour and non-tumour tissue
samples
• Tissue bank specialist staff – tissue preparation/categorising/freezing/storage
4
2.2 Feasibility – the study set-up phase
Prior to commencing a study, the feasibility of how the biological sample is to be
obtained and processed is of paramount importance. The sample process should be
dictated clearly in the study protocol, although the amount of information provided in
the protocol may vary and not be satisfactory for a junior member of staff to feel
confident to proceed. However, the clinical trial laboratory manual should clearly state
how and when samples are to be collected, processed and the data disseminated.
The research nurse should assess the practicality of the process required in handling the
sample and any potential risks identified; from the start of the study to the finish. It will
also include assessing an adequate level of competence for any staff involved in the
collection procedures and whose help may be required. It may simply involve letting
ward or clinic staff know when you will arrive as a courtesy, or relying on your theatre
staff to let you know a critical point to arrive in theatre, to collect a tissue sample from a
surgical procedure that will be used for research purposes.
If there is insufficient detail in the protocol about how the sample is to be collected and
processed, then expert advice, guidance or training should be sought from either:
Internally; associated clinical staff i.e. the chief or principal investigator, medical
laboratory staff lead, that can be identified within the Research Ethics and R&D
form, or through the study-specific protocol/proposal; information can also be
accessed internally if an ECMC centre
Or
Externally; the Chief Investigator, the Study Sponsor or the Contract Research
Organisation (CRO); via the ECMC Network Groups (Appendix 6).
By checking appropriately it ensures a good overall understanding of what is required
and if any staff members are not trained to an acceptable level, then it puts them, the
success of the sample management process and the study at risk.
To check if the study is feasible, the general points to consider are:
•
•
•
•
•
•
•
How, where and when the sample is to be collected and is the patient consent in
place, correctly completed with the approved version being used
What type of staff training is required to undertake the task and which members
of the research team need either basic sample handling skills training, or specialist
training for specific studies, which should be planned ahead of time
What facilities or equipment is required: is equipment available, in good working
order and who has the delegated operational responsibility for the equipment
What are the risks for those involved in any part of the process, has a risk
assessment been completed for the facility in which samples are to be obtained
What pre and post-sample preparation is required e.g. Check supplies/sample
kits; sample tubes/pots and are they the correct type for volume/freezer
storage/liquid nitrogen etc
Will the laboratory be ready to receive samples and is storage space available,
with an emergency back-up facility arranged in case of freezer failure
Are the laboratory staff fully informed with the correct version of the protocol,
any recent amendments, and with all consents in place
5
3. Sample preparation
The importance of sample preparation and handling cannot be emphasised strongly
enough. Each type of sample will have very specific preparation, collection, handling,
processing and storage requirements; the integrity of any sample is vital, irrespective of
the type of collection. The way a sample is collected is study/project specific and is
specific to the sample type i.e. how it should be individually collected and handled, which
may also be dependent on a defined laboratory technique that needs to be applied to
the sample/specimen; for example a particular type of assay. Generally speaking it is a
combination of the two, therefore both should be strictly observed and all related
guidance followed to preserve and protect the sample integrity.
Samples collected by a research nurse may or may not involve laboratory staff. If blood
samples are collected for research they may be whole blood samples, or samples
requiring centrifuging for serum/plasma to be pipetted off. These types of samples may
be the complete responsibility of the nurse, from patient collection to processing and
freezing the sample in a study freezer and logging the data. Therefore, any required
training or guidance must be undertaken and documented in the study log and the
individual’s Personal Development Record.
However, samples collected for research purposes can, at anytime, be reassigned to the
standard care processes for a patient, particularly if the pathological diagnosis of the
patient depends on any, or all, of the samples collected. As a result, the research sample
may subsequently have to be surrendered by a member of the research team to the
laboratory for the patient’s diagnostic purposes. Patient diagnosis from samples collected
will always take priority over any research sample collected. It is important that the
research nurse appreciates the importance of this aspect of sample collection and relies
on and acknowledges the expertise of associated staff from the areas mentioned.
Another important point to mention at this juncture is any changes in patient consent.
All patients have the right to withdraw their consent from participating in research at any
point. It is a requirement for the right to withdraw from a study to be highlighted in the
study patient information sheet. Should this withdrawal of consent occur, then the
laboratory should be notified of the change in consent. The researcher must define at
the point of application to the Research Ethics Committee (REC) what criteria will be
utilised in data and sample collection should consent be withdrawn within the course of
the study.
3.1
Research nurses and laboratory teams need to be aware of the following:
•
Timing of any sample is a critical factor. Therefore, is it physically possible to
obtain the sample in the way determined by protocol, and more specifically,
within the facility in which the study is destined to take place
•
Are the study team and laboratory staff familiar with their own individual
responsibilities in the sample collection pathway; is a delegation log in place i.e.
do the laboratory staff know what the study team are expecting of them and
when, and vice versa
•
Are the delegation responsibilities clearly defined where nurse and laboratory
staff interactions are required in the sample process. For example, when there is
6
a change in shift for laboratory staff, or during periods of sickness or annual leave
cover for the research nurse or laboratory staff. Have the details of a
second/alternative contact person been provided and who to contact in case of
emergency or breakdown of vital equipment in the sample management pathway
•
With specialised collections, who will provide any training to minimise risk e.g.
when using liquid nitrogen/other chemical reagents or gamma radiation
•
Is the necessary sampling equipment in place and are all sample storage
containers appropriate for the type of sample to be collected
•
That where necessary, a member of the medical laboratory staff is on duty to
receive the sample at the time it is to be transported to the laboratory, or when
it arrives with them via other means e.g. shipping from an external site
3.2
3.3
The important factors for the nurse to comply with are:
•
That the patient is fully informed, made aware of their right to refuse, has the
opportunity to ask any questions, is aware of what exactly they are consenting to,
is ready to proceed and is fully consented before any sample is collected
•
That the time, willingness and understanding of the patient in providing the
sample is valued and appreciated prior to collection
•
That the time and effort invested by the research nurse/study team with any
associated clinic, theatre, laboratory or other specialised staff, adds significantly to
the overall success of the study
•
That the research nurse adheres to sample specific collection and processing
instructions and has the required training to do so, or is supervised if not
•
The undertaking of, and adherence to, adequate risk assessment and standards
for COSHH requirements are fully complied with
Important factors from the laboratory perspective
On receipt of samples, the laboratory personnel are responsible for checking the samples
and confirming their integrity, including labelling, and physical state.
Specimens may arrive at the laboratory in frozen, chilled or ambient conditions that are
dictated by the stability of the samples, substances that need to be identified and
measured through investigation.
7
The following is the guidance for sample handling and tracking:
1. Frozen specimens – these samples are seen as less problematic for the
laboratory, only requiring positive confirmation that they were frozen on
arrival/receipt.
However, there can be an issue of providing couriers with instructions to
maintain dry ice if transported outside of the area. Alternatively, the
research nurse may have collected a tissue sample from theatres, which
was frozen in liquid nitrogen for transportation to the laboratory.
2. Chilled samples are more difficult to verify than samples that have been
transported under more specific conditions.
This is based purely on visual inspection and may be the case where
samples are collected in the clinic by the nurse, transported on boxed
wet ice to the laboratory, or to the sample storage facility for freezing.
3. Ambient samples are the most problematic for laboratory staff and the nurse.
It can be difficult to ascertain just what temperatures the sample has
been exposed to, or for how long. For the research nurse it is important
to collect the sample in the best way possible to preserve its integrity.
Please note that for some trials and particularly those sponsored by Pharmaceutical
Commercial companies, temperature logs are utilised. Temperature logs are often a
requirement for the movement of samples from one site to another and can be used for
any of the above temperatures. The MHRA require positive confirmation that samples
were transported at their intended temperature. The best practise is the use of data
loggers to monitor the temperature during transit; these can be provided by certain
couriers.
8
4. Sample management - safe handling
4.1
General safe handling of samples
In general, the statutory responsibility rests with the employing authority to protect staff
from any occupational hazards that they may be exposed to in the course of their duties.
For example, signs and emergency lighting showing where fire exits are and the use of
yellow warning cones when floors are wet and slippery. However, sample handling and
processing may expose the handler to a multitude of different risks that may be very
specific to a particular type of study, or process; most are minor, although some may
pose more significant risk. These risks can range from biohazards when handling blood,
serum or plasma, to radiation risks when assisting in specific techniques using radioactive
markers, or gamma radiation used in research investigating sentinel node biopsies. It is
important to check that risk assessments are undertaken, the required safety measures
are honoured and that any training required has been undertaken by any persons
involved in the sample management process.
Staff handling and transporting biological samples may need specialised training for certain
transportation substances/media used, that are deemed hazardous to health and are
under COSHH (please refer to appendix 2 for further details); for example Liquid
Nitrogen and Isopentane.
Handling any biological sample may pose a hazard or risk to the handler and the wearing
of the correct protective clothing is the responsibility of the individuals concerned, to
ensure it is adequate and fit-for-purpose; and of the employer (or sometimes the grant
holder in specialist areas) to provide it. It may simply be wearing suitable gloves (latex, or
latex-free for allergy sufferers), or full protective clothing, by way of lab coats and
gauntlets when handling liquid nitrogen. It is important that the employee is fully
prepared before commencing any sample collections or handling.
4.2
Health & Safety Executive
Since the establishment of the Health and Safety Commission (HSC) and the Health &
Safety Executive (HSE) in 1974, the health and safety legislative framework has helped to
deliver significant improvements in workplace health and safety, including a reduction of
fatalities at work by nearly two thirds. In 2008, HSC and HSE merged to become a single
unitary body, retaining the HSE name.
The HSE, working with local authorities and organisations, aims to reduce accidents and
ill-health from work-related activities. Improving health and safety outcomes can help to
improve the performance of a business.
4.3
Personal protective equipment
Personal protective equipment (PPE) is part of the everyday working life of nurses and
laboratory staff. The nurse’s uniform and the white laboratory coats supplied by our
employers are seen as tools of our trade, although it should not be assumed that they
will protect us from everything. PPE goes beyond our basic uniforms, it may be the
simple addition of gloves and face masks, to the more complex laminar flow fume
cupboards for handling bio-hazardous substances, or gauntlets when pouring liquid
9
nitrogen into a Dewar flask. It is very important to fully assess what PPE is required in
order to safely carry out any aspect of the sample handling process. Believing that
something will only take a minute, or can just be done quickly is a dangerous
misconception. Not wearing PPE could result in long-term damage to an individual who
neglected to follow advice, or in an organisation being sued for not ensuring staff are
adequately protected.
For further details on PPE, please refer to the HSE web site, information in appendices 1
and 6.
4.4
Important health and safety issues for the research nurse to consider:
•
•
•
•
•
Has a full risk assessment been undertaken and are all parties involved in the
sample management process fully informed
That the safety and well-being of all persons involved in the sample collection
process is paramount. It includes the safety of any innocent bystanders e.g. when
carrying biological samples, or substances like liquid nitrogen along a busy hospital
corridor; i.e. is it safe to do so and is the right equipment available
For any person(s) handling human biological samples, or the liquids, reagents,
assays or equipment essential to the sample processing; ensure that they have full
training in all aspects of the procedures that they are required to undertake,
before the study commences
That any special measures required in the event of breakages and/or spillages are
documented with any additional training required provided
Measures are in place of who to contact in case of emergency, for example
should a freezer breakdown, or if one of the team members with that
responsibility are on sick or annual leave
10
5. Sample management - sample processing
Sample collection procedures will vary for the type of sample required and how and
where the sample is to be collected. From the moment a research sample leaves the
patient’s body, it is vital that the sample is handled quickly, safely and appropriately for its
type.
5.1
The important issues to remember for the research nurse for the safe handling of
samples are:
•
•
•
•
The integrity of the sample is essential; each sample is different and poor or
unsafe handling techniques can impact on the research study results
The clear concise, study-specific labelling and identification of samples; (i) protects
the anonymity of the patient, (ii) forms a key part of the sample being tracked
and logged from start to finish, (iii) prevents harm to others that come into
contact with the sample unintentionally
Ensure that all samples collected, labelled, processed and stored, are data entered
into a suitable and secure form of data capture system, appropriate to the needs
of the study team and any regulatory authorities (MHRA, HTA)
That each person is aware of the specific role or duty they have to provide in the
life span of the sample collected
Samples should be obtained and handled exactly as stated in the study protocol.
Deviation from the protocol should be avoided; any unavoidable differences should be
recorded with the sample and sent in the usual way. Analysis of the sample may still be
undertaken but in the knowledge that the end result may differ from what is expected.
Unfortunately, mistakes can and do happen. Sometimes human error is inevitable in
sample handling, but as long as the nature of the deviation in procedure is recorded and
the correct safety procedures are followed, a proper risk assessment to the validity of
the data can be conducted by the laboratory and no harm will result to the handler,
patient or service users.
Training in the correct procedures can be provided within the individual centres, or as
part of a larger network, e.g. the ECMC Network Groups training days (refer to
Appendix 6 for further details).
11
6. Coding, tracking and quality assurance
Proof of sample integrity is achieved by fully tracking samples to provide a clear and
complete chain of responsibility and to meet all quality assurance (QA) measures;
enabling the study protocol to be followed for each procedure in the sample collection
pathway. The research nurse must make sure that adequate measures are in place for all
areas of interaction.
The way the sample is coded and logged by the nurse or the laboratory is very
important in the sample life cycle. The procedures that fall within this aspect are those of
QA, Quality Control (QC) and Testing. Checks can be utilised to ensure that the
process of sample identification is robust, clearly identifiable as to what the sample is,
when it was collected, and yet retains patient confidentially, by the absence of any
patient identifiable information and the use of unique identifiers.
The difference between QA, QC, and Testing can sometimes cause confusion. However,
it is important to understand their relevance and the differences between them, because
they are closely related. They are outlined below:
•
QA: Is a set of activities designed to ensure that the development and/or
maintenance of a process is adequate, defined and appropriate to ensure it is free
from bias. It forms an essential part of all sample handling and laboratory
techniques
•
QC: Is a series of actions designed to evaluate the effectiveness of a process. E.g.
Does a sample collection or laboratory process work consistently to ensure
uniformity of sample handling and prevent any defects in the sample handling
process
•
Testing: The process of implementing a system with the intention of finding any
defects. Usually trialled on pre-study samples to check for consistency and the
development of QC
Both QA and QC activities are essential activities for medical laboratory staff to
undertake.
12
7. Transportation and storage
There are many different approaches to sample tracking - electronic versus paper-based
and each is as valid as the other. Transport and storage of samples should be assessed at
the feasibility stage and prior to the study commencing. Samples need to be transported
quickly, safely and within recommended MHRA, HTA, COSHH and International Air
Transport Association guidelines (IATA); this may be in a variety ways depending on
sample type and what transportation is required (Please note Appendix 5 for IATA
regulations). Certain media, reagents, or freezing products may be used in the prepreparation or pre-analysis stage; the study team need to ensure the sample technique
required is feasible prior to starting.
It is also important to have a clear policy on what to do with unexpected, mislabelled or
unlabelled samples. The MHRA state that samples should not be analysed until the
sample ID has been established, with an exception for sample types where the failure to
analyse immediately could/will lead to the loss of data. In cases of doubt, samples should
still be analysed, but the results quarantined until sample ID is established. If this does not
become available then the sample should be destroyed and should not form part of the
analysis.
As mentioned above it is important to assess that:
•
•
•
•
•
•
•
•
As part of the initial risk assessment that a robust policy is in place should any
sampling errors occur at any time-point in the sample journey
Labels and coding used as sample identifiers are clear and suitable to be used in 80oC freezers, or other types of storage media
It is physically possible to transport the sample in the time and way specified in
the protocol and at the facility in which the study is based
The facilities are appropriate; does the geographical layout of the organisation in
which the study is to be undertaken make it practicable to run the study. For
example, is the storage facility good and within the building, or is it across the
hospital site, or in another location completely that requires sample courier, or
shipping to be arranged
Designated staff involved in the transportation of specimens are suitably trained
and qualified to protect the sample stability and integrity satisfactorily
Checking mechanisms are in place at each stage of the sample ‘journey’ from
collection to analysis, so that the sample can be tracked and traced as necessary
Has an in-house system been set up for logging samples in and out between the
study team and the various laboratory services, or storage facilities available
Are the storage facilities adequate and the freezer temperature monitored and
logged for the samples and are the details ‘who to contact out-of-hours in an
emergency’ established and clearly available
13
8. Data collection
Data collected on sample tubes and documentation must be clear, accurate and concise,
protect the confidentiality of the participant, and be of sufficient quality to satisfy the
conditions of the study and to comply with all regulatory requirements. For monitoring
and audit purposes samples must be clearly labelled and logged in a data entry sheet that is
appropriate to the study. This is to allow easy sample recognition and adequate logging to
track samples in and out of any storage facilities used for the study. It is necessary to include
details of the storage facility itself, its location, the details of ‘who to contact in an
emergency’, and details of any back-up facilities to ensure that the sample integrity is
protected and that complete and up-to-date delegations logs are available. A full record
should also be kept of each individual storage facility i.e. individual fridge, freezer, Dewar
etc., and where it is, the location of the sample in that freezer, tray, rack etc. Named
contacts have to be identified for each facility of where the samples are stored. For tissue
samples under the HTA requirements, the details of where the Licence is held and who
the designated person in authority is for the licence, should also be recorded.
The type of details to include for data collection relating to sample collections should
include the following:
•
•
•
•
•
•
•
•
•
Study sample type (on tube/vessel and log)
Time and date collected (on tube/vessel and log)
Unique identifier, number or bar code (on tube/vessel and log)
Any details of any specialised technique used
Chief or principal investigator
Named contact (on tube/vessel and log)
Any hazard relating to sample (on tube/vessel and log)
Storage location; e.g. freezer, rack/tray/position
Where appropriate, log the date that the sample is to be destroyed by;
E.g. – as per protocol, or the consenting agreement with participant
Please refer to Appendix 4 for further details regarding the Data Protection Act.
14
9. Summary and conclusion
9.1
Summary and general guidance from the laboratory perspective
•
•
•
•
•
•
•
•
•
•
•
•
The importance of robust sample tracking from the point of collection in the
clinic to the point of analysis in the laboratory cannot be over emphasised
Unlabelled samples have to be destroyed without being analysed because validity
is then questionable, if sample origin cannot be proved
There should be a major focus on ensuring that samples are labelled correctly,
uniquely identified and anonymised for GCP compliance
Good lines of communication between the trials centre and the laboratory is
essential to achieve this aim
Although the trials centre is out of the laboratory’s remit, it is recommended that
QA audits should be conducted at the trial centre, where possible, to ensure
procedures are being followed
Particular focus should be paid to sample stability issues – with the onus being on
the laboratory to provide appropriate guidance to the trial centre
It is critical that there is a backup storage location for samples in the case of a
storage location malfunction
Any computerised systems used to track samples need to undergo computer
software validation
Paper based systems require a backup copy
All sample tracking processes need to be subject to independent scrutiny and
QA audits, to ensure the validity and security of the stored information
SOPs for specimen collection and sample handling should be written, documentcontrolled and shared between the laboratory and clinic
Mistakes happen, but it is essential that any deviations from procedures are
recorded
Each different sample type and biomarker assay is likely to have individual sample
handling requirements, so please ensure that you consult with the appropriate laboratory
staff member.
9.2
Conclusion
The document provides an insight into beginning to understand how important your role
is as a research nurse or laboratory member of staff in sample collection and handling for
research purposes. It creates an overall picture of the various factors that inform good
clinical and laboratory practice for sample handling; and whilst comprehensive it is by no
means exhaustive. By providing useful information and web links to follow-up on, you
now have the responsibility to take it a step further and improve your knowledge of
sample collection and handling.
In summary, the guidance and recommendations included here highlight:
•
•
Regulatory factors that are necessary for working safely within both hospital and
laboratory environments, enhancing your role as an effective practitioner
Identifying potential risks that you may not otherwise have considered for
yourself and others and how to assess them effectively
15
•
Forming collaborative working connections within your own organisation’s is
positively encouraged, and will add relevance to the skills you are in the process
of acquiring and developing
Our patients provide the valuable samples that aid the development of new drugs and
treatments in the disease process. However, the care and consideration that you treat
their samples with, and the way in which you accurately collect data, will above all add
robustness and validity to the research study.
Ultimately your input into the whole process of sample handling will ensure that the time
and effort, given by patients, research nurses and laboratory staff, is not wasted, because
is vital to the success of any clinical research study.
16
10. Flowchart for nurses
17
11. Flowchart for laboratory staff
18
12. Sample checklist for nurses - context and detail
1. Sample preparation - protocol checks and regulations
Read sample collection section in protocol/clinical trial laboratory manual:-



Timing of sample; at what point in the patient pathway
Number of samples; from each patient and in total
Type of storage; frozen, preserved, pathology block sample
Resources required:-




Staff available; number of staff required for duration of study
Room/facility; where and when required, is a rota in place
Sample kit(s); how many required for number of samples defined
Any other sample equipment required; pipettes, sample tubes etc
Local sample handling procedures:-

Check for discrepancies between protocol requirements and local establishment
procedures
Risk assessment:-



Risk assessment completed; all aspects and as many as required
Patient safety required for procedure depending on type of sample needed
Staff safety for procedure; training that is required before starting
COSHH assessment completed (where appropriate):-


Any hazardous substances assessed; what procedures are needed
Material Data Safety Sheet checked; latest versions
2: Practical preparation
Patient consent issues:-






Correct protocol version and date of information sheet and consent form
Confirm patient consented to samples required
Consent correctly completed and signed by patient
Is patient ready to proceed and aware of what sample will be used for
Remind patient that consent can be withdrawn at any time
Remind patient that if consent withdrawn that sample/data will be destroyed
19
Facilities check:-




Location; which facility and is storage for sample readily accessible
Room booked; ensure no double booking especially if in clinic area
Bed/Clinic/Chair; is area suitable
Length of procedure; is time necessary for collection tolerable for all involved
Inform other staff members as required:-





Additional nursing/clinical medical staff; will it impinge on their course of duty
Theatres/clinic/radiology; are all poised and ready to interact as required
Laboratory staff ready to receive sample; on duty, or deputising staff ready
Ensure laboratory have relevant version of protocol, plus consent in place
Emergency procedures/staff available; if and when required
Inform patient:-




Date and time; forewarned how and when they will be approached
Location of where sample is to be collected; out-patient clinic or in-patient
Transport if required; especially of sample additional to standard care
Any specific instructions; fasting etc., or pre or post-standard procedure
Sample kit check:-



Check correct number available for samples required, per sample or study
Check type of sample tube or vessel required
If specialised kits used, check that they are in date and plenty available
Sample technique check:-





Confirm type of preserving fluid/media and that it is in date
Check order of samples to be collected, prepare tubes as necessary
Special requirements as per sample (e.g. Discard first tube etc)
Temperature to handle and transport sample in; fresh/frozen
Check transport media ready and sufficient quantity available
Assemble paperwork required:-






Check all regulatory approvals in place; e.g. Ethics, R&D, MHRA, HTA
Copy of completed consent and dated correctly
Labels – check details required for sample, are labels freeze-proof
Chain of sample custody documentation, emergency contact etc.
Case Report Form (CRF); correct numbering for study
Patient medical notes; do they match those consented
20
Availability of additional equipment:-




Centrifuge, fume hood use if required, etc
Pipettes and pipette tips
Storage vials, tubes etc
Disposal area available depending on sample type. E.g. sharps bins
N.B: Products surplus to sample must be disposed of safely and appropriately
Identify final destination of sample:-



Check freezer in good working order, at correct temp, with space available at
location
Ensure laboratory staff aware of sample arrival, is back-up freezer available
If designated laboratory staff are unavailable, is deputising member of staff on
hand
On-site checks:-


Assemble appropriate storage tubes and labels
Ensure appropriate storage available
Off-site checks:-




Ensure appropriate storage tubes
Book courier/shipping in plenty of time
If dry ice/liquid nitrogen needed for shipping, is there sufficient available
Is off-site facility ready-to-receive, and are staff available to receive
3: Sample collection checks
Patient checks:-


Ensure patient medically able to undergo procedure before starting sample
procedure
Refer patient to Doctor responsible, if concerned about whether patient is fit to
proceed
Correct trial:-



Double-check version control of protocol and is lab aware of any amendments
Cross-check patient to study type to prevent any possible error
If any error is made at any time point ensure error is recorded and logged
21
Confirm consent:-



Verbally check patient understands procedure and has asked any questions
Check patient is aware of the implications of sample collection as per standard
care
Check patient is still happy to proceed and can withdraw at any time
Confirm sample required:-



Has patient complied with any specific requirements (E.g. fasting)
Ensure appropriate sample tubes ready for samples to be collected
Ensure labels completed for sample tubes and coded appropriately
Perform procedure:-





Correct number of samples collected
Correct tubes for sample type and freezing
Correct labelling use of ID number/bar code
Correct temperature for sample collection
Log sample collection in data log for transfer to database/spreadsheet later
Patient care:-



If post-biopsy, it is important for patient to receive specific instructions
Are instructions clear, e.g. when to remove dressing/Steri-strips etc, if necessary
Ensure patient is ready to be left within standard care, after sample is collected
Inform necessary personnel:-


Lab staff/additional nursing/clinic staff/theatres/pathology/ biochemistry
Provide support as required for junior staff
Patient follow-up:-


Check any trial specific requirements or specific follow-up procedures
Check any risk of side effects due to disease or medication
22
4: Sample processing
Equipment and training




Ensure availability of equipment, e.g. centrifuge, fume hood etc.
Training check: E.g. ability to use centrifuge correctly
Check training log and identify appropriate personnel to perform process
Ensure own training is adequate and of those involved in assisting
Ensure appropriate pipette and storage tubes:-


Ability to use pipette correctly; correct sized tip of interchangeable equipment
Identify appropriate personnel to perform procedure, or ensure own training
Freezer checks:-




Prepare labels for storage tubes and labels that can withstand freezing
Training in freezing techniques etc.
Labels “future safe”, ‘out-of-hours checks, emergency contact
End date for sample disposal and ensure labelled to indicate disposal date
Transport of specimens:-





Check regulations for moving biological samples (IATA Regulations)
From patient to freezer
From freezer to lab for analysis
From freezer to ship out for external analysis
Check company Air Way Bill suitable for shipping sample as required
Data checks:-











Ensure paper trail is kept confidential to protect patient information
Ensure correct use of sample and patient ID
Complete documentation as required, sample logs, CRF's
Complete logs, freezer location, number, tray, rack position
Agree patient’s understanding of what generic consent means
If generic consent obtained ensure date for disposal of samples
Number and type of stored samples both during and at end of project
If samples not analysed - follow HTA requirements for destruction
If any errors occurred during sample handling ensure it is logged
Sample errors must be documented at the times of occurrence
Decisions should be made over whether errors should be included in final data
analysis
23
13: General checklist for laboratory staff











Examine each sample upon arrival
Comment on condition/labelling
Uniquely identify individual samples
Automated ID and bar code generation (optional)
Define storage location
Log sample details
Monitor storage temperature
Have a backup procedure in case of freezer malfunction
Record details of analysis
Sample verification during analysis by scanning barcodes
Track sample from collection through to disposal
13.1 Case Study – the M30 and M65 ELISA Assays – Biomarkers of Tumour Cell Death
To highlight the importance of sample tracking and QA, a case study involving two
biomarker assays is outlined. M30 and M65 produce quantitative data on circulating
levels of keratin 18 that have been correlated to either drug action (Pharmacological
Biomarkers); drug effect (Predictive Biomarkers) or disease outcome (Prognostic
Biomarkers) (2, 3). Two years of effort in the laboratory was necessary to validate these
assays in order to comply with GCP/GCLP requirements (4-7). However, there are a
number of sample handling issues that can affect the validity of the results, if protocols
for sample collection procedures and storage conditions are not followed and, indeed,
great care has to be exercised during patient sample collection.
For instance, a 4-hr delay in processing blood to separate plasma results in an artefactual
50% increase in the value measured by the M30 assay. The choice of serum versus
plasma gives rise to different values (20% lower in plasma), while the 2 different types of
sample also have different stability profiles. Long term storage of samples even at -800C
for more than 3 months before analysis results in marked instability in the M30 assay but
not the M65. Duplicate analysis of plasma samples give rise to much greater variability
than with serum.
13.2 References
2.
3.
4.
5.
6.
Hou, J. M., Greystoke, A., Lancashire, L., Cummings, J., Ward, T., Board, R., Amir, E., Hughes, S., Krebs, M., Hughes, A.,
Ranson, M., Lorigan, P., Dive, C., and Blackhall, F. H. Evaluation of circulating tumor cells and serological cell death
biomarkers in small cell lung cancer patients undergoing chemotherapy. Am J Pathol, 175: 808-816, 2009.
Dean, E., Jodrell, D., Connolly, K., Danson, S., Jolivet, J., Durkin, J., Morris, S., Jowle, D., Ward, T., Cummings, J., Dickinson,
G., Aarons, L., Lacasse, E., Robson, L., Dive, C., and Ranson, M. Phase I trial of AEG35156 administered as a 7-day and 3day continuous intravenous infusion in patients with advanced refractory cancer. J Clin Oncol, 27: 1660-1666, 2009.
Greystoke, A., Cummings, J., Ward, T., Simpson, K., Renehan, A., Butt, F., Moore, D., Gietema, J., Blackhall, F., Ranson, M.,
Hughes, A., and Dive, C. Optimisation of circulating biomarkers of cell death for routine clinical use. Ann Oncol, 19: 990995, 2008.
Cummings, J., Ranson, M., Butt, F., Moore, D., and Dive, C. Qualification of M30 and M65 ELISAs as surrogate biomarkers
of cell death: long term antigen stability in cancer patient plasma. Cancer Chemother Pharmacol, 60: 921-924, 2007.
Cummings, J., Ranson, M., Lacasse, E., Ganganagari, J. R., St-Jean, M., Jayson, G., Durkin, J., and Dive, C. Method validation
and preliminary qualification of pharmacodynamic biomarkers employed to evaluate the clinical efficacy of an antisense
compound (AEG35156) targeted to the X-linked inhibitor of apoptosis protein XIAP. Br J Cancer, 95: 42-48, 2006.
24
Appendix 1: Risk Assessment
For full information on Health & Safety Executive website please refer to:
www.hse.gov.uk/
1.1:
What is risk assessment?
•
A risk assessment is simply a careful examination of what, in your work, could
cause harm to people, so that you can weigh up whether you have taken enough
precautions, or should do more to prevent harm. Workers and others have a
right to be protected from harm caused by a failure to take reasonable control
measures.
•
All workers have a right to work in places where risks to their health and safety
are properly controlled.
•
Health and safety is about stopping you getting hurt at work or ill through work.
Your employer is responsible for health and safety, but you must help.
•
Accidents and ill health can ruin lives and affect your business too if output is lost,
machinery is damaged, insurance costs increase, or you have to go to court. You
are legally required to assess the risks in your workplace so that you put in place
a plan to control the risks.
There are 5 steps to risk assessment
Step 1: Identify the hazards
Step 2: Decide who might be harmed and how
Step 3: Evaluate the risks and decide on precautions
Step 4: Record your findings and implement them
Step 5: Review your assessment and update if necessary
Notes to mention before going through the steps…
Don’t overcomplicate the process. In many organisations, the risks are well known and
the necessary control measures are easy to apply. We already know about moving heavy
loads that could harm your back; or about slips and trips and advised to take all
reasonable precautions to avoid injury.
Mandatory training in moving and handling and in slips trips and falls should be
undertaken annually or as frequently as is recommended by your employer. Everyone in
the workplace has a part to play when it comes to preventing slips and trips, from the
person who designed the building to the people working inside of it. Please refer to the
Health and Safety Executive publication on preventing slips and trips at work.
http://www.hse.gov.uk/pubns/indg225.pdf
In larger organisations, ask for help from someone who is competent e.g. a Health and
Safety advisor or Risk Manager to help you. In all cases, make sure that you involve your
staff or their representatives in the process. They will have useful information about how
25
the work is done that will make your assessment of the risk more thorough and effective.
Remember you are responsible for seeing that the assessment is carried out properly.
When thinking about your risk assessment, remember…
•
•
a hazard is anything that may cause harm, such as chemicals, electricity, working
from ladders, an open drawer etc;
the risk is the chance, high or low, that somebody could be harmed by these
and other hazards, together with an indication of how serious the harm could
be.
Risk Assessment Step 1: Identify the hazards
•
First you need to work out how people could be harmed. When you work in a
place every day it is easy to overlook some hazards
•
Visit the HSE website www.hse.gov.uk
Risk Assessment Step 2: Decide who might be harmed and how
•
•
For each hazard, you need to be clear about who might be harmed; it will help
you identify the best way of managing the risk. That doesn’t mean listing
everyone by name, but rather identifying groups of people (e.g. ‘people working
in the storeroom’ or ‘passers-by’).
In each case, identify how they might be harmed, i.e. what type of injury or ill
health might occur
Risk Assessment Step 3: Evaluate the risks and decide on precautions
•
Having spotted the hazards, you then have to decide what to do about them.
The law requires you to do everything ‘reasonably practicable’ to protect people
from harm. You can work this out for yourself, but the easiest way is to compare
what you are doing with good practice.
Risk Assessment Step 4: Record your findings and implement them
• Putting the results of your risk assessment into practice will make a difference
when looking after people and your business.
• Writing down the results of your risk assessment, and sharing them with your
staff, encourages you to do this.
Risk Assessment Step 5: Review your risk assessment and update if necessary
•
•
Few workplaces stay the same. You will bring in new equipment, substances and
procedures that could lead to new hazards.
It makes sense, therefore, to review what you are doing on an ongoing basis.
Every year or so formally review where you are, to make sure you are still
improving, or at least not sliding back.
26
There is a wealth of information available to help you. More information about legal
requirements and standards can be found on the website at: www.hse.gov.uk and
particularly in the publications (available from HSE Books):
1.2:
Personal Protective Equipment (PPE)
What do the Regulations require?
The main requirement of the PPE at Work Regulations 1992 is that personal protective
equipment is to be supplied and used at work wherever there are risks to health and safety that
cannot be adequately controlled in other ways.
The Regulations also require that PPE:
•
is properly assessed before use to ensure it is suitable;
•
is maintained and stored properly;
•
is provided with instructions on how to use it safely; and
•
is used correctly by employees.
The hazards and types of PPE:
Eyes
-
Hazards: chemical or metal splash, dust, projectiles, gas and vapour,
radiation
Options: safety spectacles, goggles, face shields, visors
Head
-
Hazards: impact from falling or flying objects, risk of head bumping, hair
entanglement
Options: a range of helmets and bump caps
Breathing
-
Hazards: dust, vapour, gas, oxygen deficient atmospheres
Options: disposable filtering face piece or respirator, half or full face
respirators, air-fed helmets, breathing apparatus
Protecting the body
-
-
Hazards: temperature extremes, adverse weather, chemical or metal
splash, spray from pressure leaks or spray guns, impact or penetration,
contaminated dust, excessive wear or entanglement of own clothing
Options: conventional or disposable overalls, boiler suits, specialist
protective clothing, e.g. chainmail aprons, high visibility clothing
Hands and arms
-
Hazards: abrasion, temperature extremes, cuts and punctures, impact,
chemicals, electric shock, skin infection, disease or contamination
Options: gloves, gauntlets, mitts, wrist cuffs, armlets
27
Feet and legs
-
Hazards: wet, electrostatic build-up, slipping, cuts and punctures, falling
objects, metal and chemical splash, abrasion
Options: safety boots and shoes with protective toe caps and penetration
resistant midsole, gaiters, leggings, spats
Training for PPE
•
Make sure anyone using PPE is aware of why it is needed, when it is to be used,
repaired or replaced and its limitations
•
Train and instruct people how to use it properly and make sure they are doing
this
•
Because PPE is the last resort after other methods of protection have been
considered, it is important that users wear it all the time they are exposed to the
risk. Never allow exemptions for those jobs which take ‘just a few minutes’
•
Check regularly that PPE is being used and investigate fully any reasons why it is
not. Safety signs can be useful reminders to wear PPE
Maintenance of PPE
Make sure equipment is:
•
well looked after and properly stored when it is not being used, for example in a
dry, clean cupboard, or in the case of smaller items, such as eye protection, in a
box or case;
•
kept clean and in good repair follow the manufacturer’s maintenance schedule
(including recommended replacement periods and shelf lives). Simple
maintenance can be carried out by the trained wearer, but more intricate repairs
should only be done by specialists.
Make sure suitable replacement PPE is always readily available.
Do employers have to provide PPE?
The relevant regulations are the Personal Protective Equipment at Work Regulations
1992.
Regulation 4 states:
Every employer shall ensure that suitable personal protective equipment is provided to
his employees who may be exposed to a risk to their health or safety while at work
except where and to the extent that such risk has been adequately controlled by other
means which are equally or more effective.
The accompanying guidance states;
Employers should, therefore, provide appropriate PPE and training in its usage to their
28
employees wherever there is a risk to health and safety that cannot be adequately
controlled by other means.
In order to provide PPE for their employees, employers must do more than simply have
the equipment on the premises. The employees must have the equipment readily
available, or at the very least have clear instructions on where they can obtain it.
By virtue of Section 9 of the Health and Safety at Work etc Act 1974, no charge can be
made to the worker for the provision of PPE which is used only at work. Section 9 of the
Health and Safety at Work etc Act 1974 states:
"No employer shall levy or permit to be levied on any employee of his any charge in
respect of anything done or provided in pursuance of any specific requirement of the
relevant statutory provisions".
Section 9 applies to these Regulations because they impose a 'specific requirement' - i.e.
to provide PPE.
Other regulations
The PPE at Work Regulations do not apply where the following six sets of regulations
require the provision and use of PPE against these hazards. For example, gloves used to
prevent dangerous chemicals penetrating the skin would be covered by the Control of
Substances Hazardous to Health Regulations 2002 (as amended).
The regulations are:
•
The Control of Lead at Work Regulations 2002
•
The Ionising Radiations Regulations 1999
•
The Control of Asbestos at Work Regulations 2002
•
The Control of Substances Hazardous to Health Regulations 2002 (as amended)
•
The Noise at Work Regulations 1989
•
The Construction (Head Protection) Regulations 1989
1.3:
Reporting of Injuries, Diseases and Dangerous Occurances Regulations (RIDDOR)
On the Health and Safety Executive website details can also be found that relate to the
reporting of incidents, referred to as RIDDOR.
What is RIDDOR and who should report an incident?
The RIDDOR 1995 guidelines, place a legal duty on:
•
•
•
employers;
self-employed people;
people in control of premises;
29
Why report? Reporting accidents and ill health at work is a legal requirement. The
information enables the Health and Safety Executive (HSE) and local authorities, to
identify where and how risks arise, and to investigate serious accidents. For most
businesses and organisations a reportable accident, dangerous occurrence, or case of
disease is a comparatively rare event. It is important to find out who takes responsibility
for reporting incidents under RIDDOR
Where do you report to? Employees are responsible for reporting accidents, or anything
deemed as an incident as soon as possible after its occurrence and should seek advice
from the department that is responsible for reporting risk and incidents within the
organisation. NHS organisations and Universities employ many staff within a variety of
work areas that can be associated with risk for their employees. Generally there is a
specific Risk Management Department, or at the very least an individual with the
designated Risk Management responsibilities for the organisation concerned. The risk
management team can be contacted for assistance in assessing risk when any member of
staff is either new to the organisation, or their respective department, or in a junior role.
Accidents and incidents are reported at the nearest local point to the accident or
incident and to the person in a position of management at the time it occurs. NHS
Trusts and Universities all have an Accident or Incident report books, or forms, which
should have guidance included on how to complete the form and where each respective
copy/copies should be sent.
Junior or new staff should seek assistance from a more senior member of staff if unsure
about any aspect of the completion of a report book or form to ensure it is completed
correctly. Most forms work by a carbon copy system to enable a copy to be logged
within the department where the accident or incident occurred, with copies to be sent
to other relevant departments e.g. Risk Management. If an accident or incident occurs in
relation to a research study the study trial manager should be informed, as should the
R&D Department.
The employer’s Risk Management team can then report the accident or incident through
the appropriate channels and via the Health and Safety Executive website through an
online facility for the type of report for RIDDOR. The form that the employer submits
online goes directly to the Incident Contact Centre and a copy will be sent to the person
completing the form for their records
NB. Copies of submitted RIDDOR forms are sent to the employer or duty holder
regardless of who has submitted the report.
30
Appendix 2: COSHH: A brief guide to the Regulations
Using chemicals or other hazardous substances at work can put people’s health at risk, so
the law requires employers to control exposure to hazardous substances to prevent ill
health. Employers have to protect both employees and others who may be exposed by
complying with the Control of Substances Hazardous to Health Regulations 2002
(COSHH) (as amended).
COSHH is a useful tool of good management which sets eight basic measures that
employers, and sometimes employees, must take. These are set out in a COSHH leaflet
with a simple step-by-step approach which will help you to assess risks, implement any
measures needed to control exposure and establish good working practices.
Each member of staff, whether nursing or laboratory, that is involved in the use of
chemicals deemed as hazardous for any particular research study should find out;
•
•
•
•
•
•
what substances will be needed to undertake the study
how will the substance be used for the study and by whom
who and how often will that member of staff need to have contact with the
substance
what measures need to be undertaken for training and the facilities to use a given
substance that is hazardous is used in a safe manner
who is the designated contact should an incident occur
ensure that the eight steps outlined below are followed
Key points:
Step 1
Assess the risks
Step 2
Decide what precautions are needed
Step 3
Prevent or adequately control exposure
Step 4
Ensure that control measures are used and maintained
Step 5
Monitor the exposure
Step 6
Carry out appropriate health surveillance
Step 7
Prepare plans and procedures to deal with accidents, incidents and emergencies
Step 8
Ensure employees are properly informed, trained and supervised
What COSHH requires – Following these eight steps:
Step 1
Assess the risks
Step 2
Decide what precautions are
needed
E.g. the risks to health from hazardous
substances used in, or created by your
workplace activities
Employers must not carry out work which could
expose employees to hazardous substances,
without first considering the risks and the
necessary PPE precautions, and what else is
required to comply with COSHH, see above
31
Step 3
Prevent or adequately control
exposure
Step 4
Ensure that control measures
are used and maintained
Step 5
Monitor the exposure
Step 6
Carry out appropriate health
surveillance
Step 7
Prepare plans and procedures
to deal with accidents, incidents
and emergencies
Step 8
Ensure employees are properly
informed, trained and
supervised
Employers must prevent employees being
exposed to hazardous substances. Where
preventing exposure is not reasonably
practicable, then employers must adequately
control it. The advice in the COSHH leaflet and
other guidance available helps with making risk
assessments, ensuring the appropriate controls
are in place and equipment available as required
Ensure that control measures are used e.g. PPE,
that they are maintained properly and damaged
equipment is repaired or replaced and that all
safety procedures are followed
For example monitoring the exposure of
employees to radiation when working with
radiological techniques (emission badges), or
when a hazardous substance is used that emits a
harmful vapour
Employers have to carry out appropriate health
surveillance where assessment deems it as
necessary, for example Hepatitis checks on
employees exposed to potential risk from
venepuncture, or where COSHH sets specific
requirements
Plans and procedures to deal with accidents,
incidents and emergencies involving hazardous
substances used in sample handling, must be
implemented, in addition to those that are the
general responsibility of the employers
Employers should provide employees with
suitable and sufficient information, instruction
and training. For example; lifting and handling, fire
training, major incident training
COSHH assessment: Identifying hazard and assessing risk
You are probably already aware of many risks in your area of work. A COSHH
assessment concentrates on the hazards and risks from substances in your workplace. To
complete a thorough COSHH assessment you will need to understand how a substance
is to be used, and any controls that need to be implemented to mitigate risk. If you are
not the person performing the COSHH assessment, but are aware of any of these risks,
you should ensure the person responsible for the assessment is fully aware of them.
Remember that hazards and risks are not limited to substances labelled as ‘hazardous’.
Steps to making a COSHH assessment:
•
Walk around your workplace. Where is there potential for exposure to
substances that might be hazardous to health?
Examples include processes that emit dust, fume, vapour, mist or gas; and skin
contact with liquids, pastes and dusts. Substances with workplace exposure limits
(WEL’s) are hazardous to health.
•
In what way are the substances harmful to health?
32
Get safety data sheets, and read relevant material. Some substances arise from
processes and have no safety data sheet. Look at the HSE web pages for your
area of work.
•
What jobs or tasks lead to exposure?
Note these down. Note down what control measures you already use. For these
jobs, how likely is any harm to workers’ health?
•
Are there any areas of concern, e.g. from the Accident/Incident Book?
Examples include burns from splashes, nausea or light-headedness from solvents,
etc
HSE has produced general guidance called 5 steps to risk assessment. You can apply
this to substances hazardous to health. More detailed guidance is in the free booklet
on working with substances hazardous to health. Working with substances hazardous
to health: What you need to know about COSHH. INDG136 [190KB]
Safety data sheets provide information on substances that are ‘dangerous for supply’.
Other substances should have instructions for safe use.
By law, your supplier must give you an up to date safety data sheet for a substance
that is ‘dangerous for supply’. Safety Data Sheets are often hard to understand,
though this explanation might help. Keeping a copy of the safety data sheet is not a
COSHH assessment.
COSHH Essentials: COSHH Essentials was developed and launched in 1999 to protect
workers from health risks from chemicals. It uses a unique system of hazard risk banding
to provide small and medium enterprises with a simple solution for carrying out a risk
assessment under the Control of Substances Hazardous to Health Regulations
(COSHH). The system identifies the proper controls for the substances used and the
way in which they are used. In 2001, research was undertaken to convert the paper
version of COSHH Essentials into an electronic expert system, which carries out all
calculations behind the scenes making it even simpler and quicker to use. The user is able
to print off or download all the information needed to provide proper controls from
exposure to chemicals in their workplace. The tool is available free on the Internet at:
www.coshh-essentials.org.uk.
Please see an example of a safety assessment overleaf
33
Example: Safety Assessment - COSHH Risk Assessment
Procedure name: Cryotomy
Date of
assessment:
DD/MM/YYYY
Review date:
Assessor signature:
Substances
used:
Name
Hazard
category
Nature
of
hazard
Quantity
used
Type of process
Exposure
potential
Precautions
Liquid
Nitrogen
TH3
Causes
burns.
1 litre
Filling up Dewar
flask and putting
in samples from
necropsy.
Medium
Wear cryo-gloves. Use
forceps when handling
frozen samples.
< 10ml
Frozen Iso
Pentane
TH3
100ml
Causes
burns.
Taking samples
out of liquid
nitrogen fridge
onto LB.
Placing samples
into beakers of
frozen
(-80c) pentane.
In FC/VC
Low
Medium
Use of gloves or forceps
Care to be taken when
handling frozen tisssue.
Use forceps and/or ties
when handling beakers.
Relevant references: HSE website; Material Safety Data Sheets
Comments and exclusions: Care to be taken when handling frozen tissue, use forceps whenever practically
possible.
Emergency procedures: In case of burns cover immediately and seek urgent medical attention.
Key: FC = Fume cupboard; VC = Ventilated cupboard; LB = Open laboratory bench
34
Appendix 3: Good Clinical Practice for Clinical Laboratories
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstan
dards/GoodClinicalPracticeforClinicalLaboratories/CON041197
The full version of the document can be accessed via the above link and a detailed
overview is provided below:Guidance on the maintenance of regulatory compliance in laboratories that perform the
analysis or evaluation of clinical trial samples
1. Foreword
The Medicines for Human Use (Clinical Trials) Regulations 2004 (the Regulations)
regulate the conduct of clinical trials in the United Kingdom. The regulations relate to
persons or organisations that participate in any aspect of a human clinical trial including
organisations that analyse or evaluate samples collected as part of a clinical trial. The
purpose of this guidance document is to provide such facilities with information that will
help them develop and maintain quality systems which will comply with the Regulations.
It will also provide information on the expectations of the MHRA’s inspectors who may
be assigned to inspect facilities that perform work in support of human clinical trials.
2. Introduction
The transposition of the EU Clinical Trials Directive 2001/20/EC into UK law (The
Medicines for Human Use (Clinical Trials) Regulations 2004, Statutory Instrument 2004
No.1031. as amended) provides provision for the inspection of laboratories that perform
the analysis or evaluation of samples collected as part of a clinical trial. In the UK, the
Medicines and Healthcare products Regulatory Agency (MHRA) has responsibility for
monitoring such laboratories for compliance with these Regulations. Compliance is
assessed by inspections which will be performed approximately every two years.
However, it is important to note that the frequency of inspections may increase or
decrease in line with the MHRA’s risk assessment process depending on the level of
compliance maintained by the laboratory.
The analysis of samples collected from healthy volunteers and patients participating in
clinical trials forms a key part of the clinical trials process. Sample analysis or evaluation
provides important data on a range of endpoints which is used, for example, to assess
the pharmacokinetic profile of investigational medicinal products and to monitor their
safety and efficacy. Consequently, it is essential that sample analysis or evaluation is
performed to an acceptable standard which will ensure patient safety is not
compromised and that data is reliable and accurately reported.
3. Glossary of terms
“Amendment to the clinical trial authorisation” means an amendment to:
(i) The terms of the request for authorisation to conduct that trial or the application
for an ethics committee opinion in relation to that trial,
(ii) The protocol for that trial, or
(iii) The other particulars or documents accompanying that request for authorisation
or application for ethics committee approval
35
“Substantial amendment to the clinical trial authorisation” means an amendment to the
clinical trial authorisation which is likely to affect to a significant degree:
(i) The safety or physical or mental integrity of the subjects of the trial,
(ii) The scientific value of the trial,
(iii) The conduct or management of the trial, or
(iv) the quality of safety of any investigational medicinal product used in the trial
“Archivist” means the person responsible for the management of the archive.
“Chief Investigator” means:
(a)
In relation to a clinical trial conducted at a single trial site, the investigator for that
site, or
(b)
In relation to a clinical trial conducted at more than one trial site, the authorised
health professional, whether or not he is an investigator at any particular site,
who takes primary responsibility for the conduct of the trial.
“Clinical Kit” means the necessary components required to collect clinical trial samples
prior to their analysis of evaluation in a laboratory.
“Clinical Protocol” is a document that describes the objectives, design, methodology,
statistical considerations and organisation of a clinical trial.
“Clinical Trial” means any investigation in human subjects, other than a noninterventional trial, intended;
(a)
To discover or verify the clinical, pharmacological or other pharmacodynamic
effects of one or more medicinal products
(b)
To identify any adverse reactions to one or more such products, or
(c)
To study absorption, distribution, metabolism and excretion of one or more such
products, with the object of ascertaining the safety or efficacy of those products.
“Computerised System” is a system (consisting of one or more hardware components
and associated software) that is involved with the direct or indirect capture of data,
processing or manipulation of data, reporting and storage of data, and may be an integral
part of automated equipment. Examples include: a programmable analytical instrument
or a personal computer linked to a laboratory information management system.
“Clinical Trials Regulations” - means Statutory Instrument 2004:1031 (as amended). Part
1 Regulation 2 contains interpretations and definitions of key phrases used within the
Regulations, it is recommended these terms are referred to when reading the regulations
and developing systems and procedures to assure the quality of clinical laboratory
procedures and data.
“Schedule 1” of the Clinical Trials Regulations SI 2004:1031, as amended, contains
information relating to the conditions and principles of good clinical practice applicable to
all trials, and the protection of clinical trial subjects.
“Subject” means, in relation to a clinical trial, an individual, whether a patient or not, who
participates in a clinical trial –
(i) As a recipient of an investigational medicinal product or of some other treatment
or product, or
(ii) Without receiving any treatment or product, as a control.
“Clinical trial samples” means any sample collected from a participant of a clinical trial as
required by the clinical protocol. Samples may include but are not limited to: plasma,
serum, urine, faeces, tissues and cells.
“Declaration of Helsinki” means the Declaration of Helsinki adopted by the World
Medical Assembly in June 1964, and subsequent amendments as referenced in Directive
2005/28/EC, Chapter 2, Article 3 “EU Directive” means Directive 2001/20/EC of the
th
European Parliament and the Council of 4 April 2001 on the approximation of the laws,
36
regulations and administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical trials on medicinal
products for human use and Commission Directive 2005/28/EC laying down principles
and detailed guidelines for good clinical practice as regards investigational medicinal
products for human use, as well as the requirements for authorisation of the
manufacturing and importation of such products.
Part 1, Regulation 2 of the Clinical Trials Regulations: "conducting a clinical trial" includes
–
Carrying out any test or analysis –
(i) To discover or verify the clinical, pharmacological or other pharmacodynamic
effects of the investigational medicinal products administered in the course of the
trial,
(ii) To identify any adverse reactions to those products, or
(iii) To study absorption, distribution, metabolism and excretion of those products,
but does not include any activity undertaken prior to the commencement of the
trial which consists of making such preparations for the trial as are necessary or
expedient;
“Good Clinical Practice” (GCP) means a standard for the design, conduct, performance,
monitoring, auditing, recording, analysis, and data reporting of clinical trials that provides
assurance that the data and the reported results are credible and accurate, and that the
rights, integrity, and confidentiality of the trial subjects are protected.
“Investigational Medicinal Product” means a pharmaceutical from an active substance or
placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical
trial, and includes a medicinal product which has marketing authorisation, but is for the
purposes of the trial:
(i) used or assembled (formulated or packaged) in a way different from the form of
the product authorised under the authorisation;
(ii) used for an indication, not included in the summary of product characteristics
under the authorisation for that product, or(iii) used to gain further information
about the form of that product as authorised under the authorisation.
“Laboratory” means a facility that conducts manipulation, analysis or evaluation of
samples collected as part of a clinical trial; such analysis or evaluation may include the
generation of pharmacokinetic data, safety data, primary efficacy data, histopathology
data or data used to support any other stated end point.
“Laboratory management” is the individual(s) having control and formal responsibility for
the organisation and functioning of a laboratory in which work that forms part of a
clinical trial is conducted.
“Master Service Level Agreement” is an overarching contract of general terms &
conditions between two parties such as a laboratory and a sponsoring organisation which
may be used to underpin work for a number of clinical trials. Study-specific terms,
conditions, details, roles and responsibilities are then further defined in other
documented agreements.
“Principal Investigator” means, in relation to a clinical trial, the authorised health
professional responsible for the conduct of that trial at a trial site, and if the trial is
conducted by a team of health professionals at a trial site, the principal investigator is the
leader responsible for that team.
“Quality Assurance personnel” (QA) means, the individual(s) who are responsible for
maintaining the laboratories quality assurance processes. (See “Quality Assurance
processes”).
“Quality Control” (QC) means a formal process for the systematic checking of processes
and data to ensure accuracy.
37
“Quality assurance processes” are defined as the activities employed by an organisation
to ensure that regulatory requirements are met and internal standards maintained. These
activities are documented, established and managed in a systematic and visible manner,
with a clear focus on prevention. Quality Assurance activities should be performed by
staff who are not directly involved with the analysis of clinical samples.
“Source Data” All information in original records and certified copies of original records
of clinical findings, observations, or other activities in a clinical trial, necessary for the
reconstruction and evaluation of the trial. Source data are contained in source
documents (original records or certified copies).
“Source Documents” Original documents, data, and records (e.g., hospital records,
clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation
checklists, pharmacy dispensing records, recorded data from automated instruments,
copies or transcriptions certified after verification as being accurate copies, microfiches,
photographic negatives, microfilm or magnetic media, x-rays, subject files, and records
kept at the pharmacy, at the laboratories and at medico-technical departments involved
in the clinical trial).
“Serious Breach” is a breach which is likely to affect to a significant degree:
(i) The safety of physical or mental integrity of the subjects of the trial; or
(ii) The scientific value of the trial.
Regulation 29A of The Medicines for Human Use (Clinical Trials) Regulations 2004 (as
amended) states that the sponsor of a clinical trial shall notify the licensing authority in
writing of any serious breach of:
(i) The conditions and principles of good clinical practice in connection with that
trial; or
(ii) The protocol relating to that trial, as amended from time to time in accordance
with regulations 22 to 25, within 7 days of becoming aware of that breach.
“Sponsor” in relation to a clinical trial means, the individual(s) who takes responsibility for
the initiation, management, and financing (or arranging the financing) of that trial.
“Validation of a computerised system” is a documented process that demonstrates that a
computerised system is suitable for its intended purpose.
“Work instruction” is a written plan which will include, but is not limited to, the purpose
of the analysis and the methodology that will be used to perform the analysis. This may
also be referred to as an “analytical protocol” or an “analytical plan”.
38
Appendix 4: Data Protection Act
Collection of any data is covered by the Data Protection Act 1998 and the 8 Data
Protection Principles outline the legislation in force, these are that data is;
•
Processed fairly and lawfully
•
Processed only for one or more specified and lawful purpose
•
Adequate, relevant and not excessive for those purposes
•
Accurate and kept up to date – data subjects have the right to have inaccurate
personal data corrected or destroyed if the personal information is inaccurate to
any matter of fact
•
Kept for no longer than is necessary for the purposes it is being processed
•
Processed in line with the rights of individuals – this includes the right to be
informed of all the information held about them, to prevent processing of their
personal information for marketing purposes, and to compensation if they can
prove they have been damaged by data controller’s non-compliance with the Act
•
Secured against accidental loss, destruction or damage and against unauthorised
or unlawful processing – this applies to you even if your business uses third party
to process personal information on your behalf
•
Not transferred to countries outside the European Economic Area – the EU plus
Norway, Iceland and Liechtenstein – that does not have adequate protection for
individuals’ personal information, unless a condition from Schedule four of the
Act can be met
39
Appendix 5: IATA Dangerous Goods Regulations and Infectious substances
NB: Please note that there may be variation in appearance and text
from one ‘Air Way Bill’ used by one company to that of another. The
way in which an Air Way Bill is formatted is at the discretion of the
company that is used for the transportation and shipment of samples. As long as the
IATA regulations are applied, then there is no cause for concern. If specific details need
to be added for the particular transportation/shipment of a sample then raise a query
with the company concerned so that the sample is shipped to your satisfaction.
Dangerous goods regulations
PACKING INSTRUCTION 650
STATE VARIATIONS: DQG-03
OPERATOR VARIATIONS: AF-04, AO-03, AS-08, CO-07, CS-07, FX-09, LA07, LH-12, QF-03
General Requirements
Diagnostic specimens must be packed in good quality packaging, which must be strong
enough to withstand the shocks and loadings normally encountered during transport,
including trans-shipment between transport units and warehouses as well as any removal
from a pallet or over pack for subsequent manual or mechanical handling. Packagings
must be constructed and closed so as to prevent any loss of contents when prepared for
transport which might be caused under normal conditions or transport, by vibration, or
by changes in temperature, humidity or pressure.
Primary receptacles must be packed in secondary packagings in such a way that, under
normal conditions of transport, they cannot break, be punctured or leak their contents
into the secondary packaging. Secondary packagings must be secured in outer packagings
with suitable cushioning material. Any leakage of the contents must not substantially
impair the protection properties of the cushioning material or of the outer packaging.
Packages must be prepared as follows:
(a) For Liquids:
•
•
•
•
The primary receptacle(s) must be leak-proof and must not contain more than
500ml;
There must be absorbent material placed between the primary receptacle and
the secondary packaging; if several fragile primary receptacles are placed together
in a single secondary packaging, they must be either individually wrapped or
separated as to prevent contact between them. The absorbent material, such as
cotton wool must be in sufficient quantity to absorb the entire contents of the
primary receptacles and there must be a secondary packaging which must be
leak-proof.
The primary receptacle or the secondary packaging must be capable of
withstanding, without leakage, an internal pressure producing an internal pressure
differential of not less than 95kPa in the range of –40°C to 55°C (-40°F to
130°F).
The outer packaging must not contain more than 4L.
40
(b) For Solids:
•
•
•
•
•
•
The primary receptacle(s) must be sift-proof and must not contain more than
500g.
If several fragile primary receptacles are placed in a single secondary packaging,
they must be either individually wrapped or separated so as to prevent contact
between them and there must be a secondary packaging which must be leakproof.
The outer packaging must not contain more than 4kg.
An itemised list of contents must be enclosed between the secondary packaging.
Each completed package must be capable of successfully passing the drop test
described in 6.6.1 except that the height of the drop must not be less than 1.2M.
Packages must have one side with dimensions of not less than 100mm x 100mm
(4in x 4in) or packages must be in an over pack that has one side with
dimensions of not less than 10mm x 100mm (4in x 4in).
Each package and the “Nature and Quantity of Goods” box of the air way bill must
show the text “DIAGNOSTIC SPECIMENS”. Each package must also be marked in
accordance with 7.1.5.8 to indicate that the shipper has determined that the packaging
meets the applicable air transport requirements. The marking must be applied adjacent
to the works “Diagnostic Specimen”.
A shippers Declaration for Dangerous Goods is not required.
Provided diagnostic specimens are packed in accordance with this Packing Instruction, no
other requirements of these regulations apply except for the definition in 3.6.2.1.4 and
the reporting of dangerous goods accidents and incidents in 9.6.1. However, where
carbon dioxide, solid (dry ice) or liquid nitrogen is used to keep specimens cold, all
applicable requirements of these Regulations must be met.
Specific Requirements
Although exceptional cases, (for example, the shipment of whole organs) may require
special packaging, the great majority of diagnostic specimens can and must be packaged
to the following guidelines.
Substances shipped at ambient temperatures or higher: Primary receptacles include those
of glass, metal or plastic. Positive means of ensuring a leak-proof seal, such as heat seal,
skirted stopper or metal crimp seal must be provided. If screw caps are used these must
be reinforced with adhesive tape.
41
Infectious Substances
Based on requests from industry the requirement shown in Packing Instruction 650 for
the number of packages to be provided on the Air Waybill, when an Air Waybill is used,
will be modified to become a recommendation for 2010. The provision of the number
of packages will become mandatory with effect 1 January 2011. Infectious Substance
Notice (pdf)
Details of infectious substances and transportation under the IATA regulations can be
found on the following website:
http://www.iata.org/SiteCollectionDocuments/Documents/Guidance_Doc62DGR_51.pdf
Definitions relating to infectious substances:Infectious substances are substances which are known to contain, or are reasonably
expected to contain, pathogens. Pathogens are defined as micro-organisms (including
bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can
cause disease in humans or animals.
Cultures are the result of a process by which pathogens are intentionally propagated.
This definition does not include human or animal patient specimens. Patient specimens
are those collected directly from humans or animals, including, but not limited to,
excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts
being transported for purposes such as research, diagnosis, investigational activities,
disease treatment and prevention
The general requirements should be followed as good practice in the transportation of
goods when not all samples are deemed ‘infectious’.
42
Appendix 6: Useful websites and contact details
6.1: ECMC Website
For further details on the Experimental Cancer Medicine Centres initiative and four
Network Groups, please follow the below link:
http://www.ecmcnetwork.org.uk/
To join our Early Phase Translational and Research Nurse, Bioanalysis and Quality
Assurance and Operational Network Groups, please contact the ECMC Secretariat on:
ecmc.admin@cancer.org.uk
6.2: The Human Tissue Authority (HTA)
http://www.hta.gov.uk
The HTA is a watchdog that supports public confidence by licensing organisations that
store and use human tissue for purposes such as research, patient treatment, postmortem examination, teaching, and public exhibitions. They also give approval for organ
and bone marrow donations from living people.
6.3: The Health and Safety Executive (HSE)
(http://www.hse.gov.uk/risk/risk-assessment-and-policy-template.doc)
Health and Safety in the Laboratory details found on the HSE website:
http://www.hsl.gov.uk/
Controlling Hazards
Improving Health
Understanding Human Factors
Personal Protective Equipment (PPE)
http://www.hse.gov.uk/pubns/indg174.pdf
Do employers have to provide PPE?
http://www.hse.gov.uk/contact/faqs/ppe.htm
Relevant publications
Personal protective equipment at work: guidance on regulations, L25, (ISBN 0717604152
- available from HSE Books)
A short guide to the Personal Protective Equipment at Work Regulations - free leaflet
HSE: Research and Science:
http://www.hse.gov.uk/research/content/gl2005.htm
Where you will find new guidelines released this year entitled:
HSE statement for the implementation of the chief scientific adviser's guidelines 2010
43
http://www.sro.hse.gov.uk/PublicPages/default.aspx
The HSE’s Interactive Newsletter called Science & Research Outlook
6.4: The Medicines and Healthcare products Regulatory Agency (MHRA)
MHRA Online Services
General enquiries: 020 7084 2000 info@mhra.gsi.gov.uk
Home page: http://www.mhra.gov.uk/index.htm
MHRA- Information for healthcare professional specialties:
http://www.mhra.gov.uk/Safetyinformation/Healthcareproviders/index.htmAs part of the
MHRA’s continuing drive to support healthcare professionals, they have set up a section
comprising of information relevant to different healthcare professional specialities. All
clinical staff involved in the following areas listed below use and manage a wide range of
medicines and medical devices. The MHRA web pages have been specifically adapted to
the needs of clinical staff. The web pages include guidance, safety alerts and links to
educational material to assist clinical care practitioners in the safe use and management
of medicines and medical devices. There are separate sections on:
o Anaesthetics
o Cardiology
o Care home staff
o Critical care
o Orthopaedics
o Obstetrics and gynaecology
o Ophthalmology
o Paediatrics
o Pathology
o Pharmacy
o Physiotherapy and occupational therapy
o Radiology
o Theatre Practitioners
Modified: 06 October 2010
MHRA - Safety
http://www.mhra.gov.uk/Safetyinformation/index.htm
Safety warnings, alerts and recalls
This section includes current and
historic Drug Alerts on defective
medicines, Medical Device Alerts and
safety warnings and messages about
medicines, including letters sent to
health professionals.
http://www.mhra.gov.uk/Onlineservices/Medicines/index.htm
This section gives all the relevant information on reporting adverse incidents involving
medicines.
44
http://www.mhra.gov.uk/Onlineservices/Devices/index.htm
This section gives all the relevant information on reporting adverse incidents involving
medical devices, including details on the updated online reporting system.
http://www.mhra.gov.uk/Onlineservices/Blood/index.htm
MHRA- Reporting serious adverse events and serious adverse reactions related to blood
and blood components
The UK Blood Safety and Quality Regulations 2005 and the EU Blood Safety Directive
require that serious adverse events and serious adverse reactions related to blood and
blood components are reported to the MHRA, the UK Competent Authority for blood
safety.
MHRA- Patients and the Public
http://www.mhra.gov.uk/Patientsandpublic/index.htm
This section provides targeted links to information throughout the site which is aimed
specifically at patients and the public.
6.5 The National Patient Safety Agency (NPSA)
http://www.npsa.nhs.uk/
The NPSA leads and contributes to improved, safe patient care by informing, supporting
and influencing the health sector.
The organisation is an Arm’s Length Body of the Department of Health and through our
three divisions cover the UK health service.
National Reporting and Learning Service: http://www.nrls.npsa.nhs.uk/
Aims to reduce risks to patients receiving NHS care and improve safety.
National Clinical Assessment Service (NCAS): http://www.ncas.npsa.nhs.uk/
Supports the resolution of concerns about the performance of individual clinical
practitioners to help ensure their practice is safe and valued.
National Research Ethics Servcie (NRES): http://www.nres.npsa.nhs.uk
The National Research Ethics Service (NRES) has a dual mission:
• To protect the rights, safety, dignity and well-being of research
participants; and
• To facilitate and promote ethical research that is of potential benefit to
participants, science and society
To create a new application form to apply for NHS Ethical Approval please visit the
following website for information: https://www.myresearchproject.org.uk/
Here you can access all of the related forms that you will need for your application
through the Integrated Research Application System – IRAS
45
Appendix 7: Glossary List
COSHH
Control Of Substances Hazardous to Health
CRF
Case Report Form
CRO
Contract Research Organisation (Or can also be Clinical Research Officer
in some cases)
ECMC
Experimental Cancer Medicine Centre
GCP
Good Clinical Practice
GCPClinLab Good Clinical Laboratory Practice
or GCP(L)
HSC
Health and Safety Commission
HSE
Health and Safety Executive
HTA
Human Tissue Authority
IATA
International Air Transport Association
ICH
International Conference on Harmonization (of Technical Requirements
for Registration of Pharmaceuticals for Human Use)
IRAS
Integrated Research Application System
MHRA
Medicines and Healthcare products Regulatory Agency
NCAS
National Clinical Assessment Service
NHS
National Health Service
NPSA
National Patient Safety Agency
NRES
National Research Ethics Service
PPE
Personal Protective Equipment
46
R&D
Research and Development
REC
Research Ethics Committee
RIDDOR
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
SOPs
Standard Operating Procedures
QA
Quality Assurance
QC
Quality Control
WEL
Workplace Exposure Limits
47

ECMC Secretariat Team Meeting - Leeds Teaching Hospitals NHS

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