Radioactive Biological
Samples Policy
Manager responsible (name and title)
Adrian Tookman,
Trust Lead for Radiation
Date published (this version)
May 2012
Last Review date
Jun 2013
Next Review date
Jun 2015
Approved by (name of committee)
Radiation Board
Related policies
Infection control – Standard precautions
Infection Control – Specimen Collection
Date policy impact assessment carried out
27 March 2007
Result of policy impact assessment
Race:
Disability:
Age:
Gender:
Religion /belief:
Sexual
orientation:
Version control
5.1
Dominic Dodd, chairman
David Sloman, chief executive
Not equality relevant
Not equality relevant
Not equality relevant
Not equality relevant
Not equality relevant
Not equality relevant
www.royalfree.nhs.uk
Page 1 of 12
Statement regarding
equality impact assessment
We welcome feedback on this policy and the way it operates. We are interested to know
of any possible or actual adverse impact that this policy may have on any groups in
respect of race, disability, gender, sexual orientation, age, religion/belief or other
characteristics.
The person responsible for equality impact assessment for this policy is Jill Hull,
Assistant Director Service Development.
This policy has been screened to determine equality relevance for the following equality
groups: race, disability, age, gender, sexual orientation, religion/belief. The policy is
considered to have little or no equality relevance in itself, but is a tool for highlighting and
promoting equality assessment.
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 2 of 12
Contents
1
2
2.1
2.2
3
4
4.1
4.2
4.3
5
5.1
5.2
6
7
8
9
10
11
12
13
14
Introduction .............................................................................................................................. 4
Infection control ....................................................................................................................... 4
Standard precautions ....................................................................................................... 4
Specimen collection ........................................................................................................ 5
Radiation hazards ..................................................................................................................... 5
Minimising Radiation Risk ...................................................................................................... 6
Labelling of samples ....................................................................................................... 6
Sample packaging ........................................................................................................... 7
Leaking samples .............................................................................................................. 7
Specific advice for different patient groups ............................................................................. 7
Nuclear medicine patients ............................................................................................... 7
Sealed source therapy (brachytherapy) ........................................................................... 8
Activities above which precautions additional to "Standard Precautions" may be necessary . 8
Radioactive organ and tissue samples .................................................................................... 10
Radiation Local Rules and radiation risk assessments ........................................................... 10
Radioactive waste................................................................................................................... 11
Advice on radiation safety ..................................................................................................... 11
References .............................................................................................................................. 12
Arrangements for reviewing this policy ................................................................................. 12
Policy authors ......................................................................................................................... 12
Policy review .......................................................................................................................... 12
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 3 of 12
1
Introduction
Adoption of the requirements of this Policy document will ensure that radioactive
biological samples are correctly labelled, handled and disposed safely.
Biological samples (blood, urine, tissues or organs) obtained from patients who have
recently received radioactive materials for the purposes of therapy or diagnosis are likely
to be radioactive. In general, such samples will contain very low levels of radioactivity and
consequently do not pose a significant risk to staff provided Standard Precautions and
the Specimen Collection policy are adhered to (see section 2 below). Additional
precautions are needed when taking or handling samples from patients who have
recently received a therapeutic radionuclide administration (see section 4 below) and for
excised organs and tissue samples (see section 7 below).
In all cases, the handling of radioactive biological samples should be performed with the
aim of minimising risk. The minimisation of risk can generally be achieved by following
trust policies on Standard Precautions and Specimen Collection. For patients being
cared for in a radiation controlled area (e.g. rooms 6-10 on 11E ward or 16 & 17 on 12Eb
ward) after a therapeutic radionuclide administration, additional precautions are required
in line with the warning notice placed at the entrance to the controlled area. (A similar
situation may also apply after an iodine seed implant.). The scope of this policy only
includes the handling of specimens once they have been taken from the patient and do
not address any other issues that may be involved in collection of the samples. The
period over which samples are required to be treated as radioactive will depend on the
type of radioactive material administered, and guidelines on how long precautions need
to be adopted after the radioactive administration will be advised by the departments
responsible for their administration. For laboratories, there is a quick guidance summary
of for Handling, storing and disposing of Radioactive Samples from therapeutic patients
on wards 11E and 12Eb.doc
The training requirements for moving and handling of radioactive samples should be
dealt with locally. Risk assessments should inform the way specimens are taken and
moved from one place to another. This should also be stated in the Local Rules (if
available). All radioactive specimens should be hand delivered to the laboratory
concerned and not put in the air chute system.
2
2.1
Infection control
Standard precautions
The trust has adopted a policy of Standard Precautions and all samples will be assessed
to be of the same risk regardless of whether they are known to have an infection or not.
All biological samples are regarded as hazardous, and the following guidelines should be
followed:
Do not contaminate the form with the sample
Using gloves ensure that the container is securely sealed.
Use the appropriate plastic specimen bag which segregates the sample from
request form. The specimen bag must be sealed securely.
Clinical details must be provided.
All specimens must be regarded as potentially infective.
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 4 of 12
Since any request exposes laboratory personnel to some risk, only request those tests
which are necessary.
2.2
Specimen collection
Specimens must be labelled and collected in accordance with the Trust “Infection Control
– Specimen Collection” policy.
That policy details arrangements for performing the following:
Policy for specimen collection from wards
Patient identification
Taking patient specimens
Labelling of specimens.
Movement of specimens from the wards to the laboratories
3
Radiation hazards
There are two kinds of hazard to be considered when dealing with all radioactive
samples, these are;
External radiation exposure
Internal radiation exposure
External radiation exposure:
Radiation doses arising from exposure to samples are likely to be small but it is important
to assess each situation (organ/radionuclide) by performing adequate risk assessments
(see section 7) and implementing the appropriate mitigating procedures.
Where practicable, radiation dose may be minimised by reducing the handling time
and/or using forceps to increase the distance from the sample. If forceps are used, extra
care must be taken not to drop the samples.
Internal radiation exposure
This is possible via:
Open wounds
Ensure that open wounds are sealed, that gloves and protective
clothing are worn
The mouth
This is usually transferred from hands therefore ensure that
gloves are worn and changed frequently and that hands are
washed thoroughly before touching one’s skin.
Inhalation
This is mainly from volatile radioactive material. As this is not
significant for clinical samples, the risk is extremely low
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 5 of 12
4
Minimising Radiation Risk
The radiation risk, from the taking and handling of radioactive samples, is principally
dependent on:
The amount of radioactivity within the sample.
Sample volume and number of samples taken.
The nature of radioactive emission from the radionuclide concerned.
The sample collection method and technique.
Risk minimisation for each of the above will be considered.
Amount of radioactivity within the sample
The sample activity will reduce with both the physical decay of the radionuclide and
excretion rate. The physical decay and its half-life is a fixed quantity. Excretion rate may
vary with the health of the patient. In order to minimise risk samples should be taken,
whenever possible, before the patient has radioactive material administered. Unless
clinically urgent, once radioactive material has been administered sample taking should
be delayed for as long as is practicable, to maximise physical decay and biological
excretion.
Sample volume and number of samples
When clinically urgent samples are required the volume (ml) and number of samples
should be minimised.
The nature of radioactive emission from the radionuclide concerned
Once administered the nature of the radiation emitted will not change however dose
reduction can be optimised by using the most appropriate shielding and distance. A risk
assessment should be carried out to find out the most appropriate shielding to be used.
Advice can be obtained from a radiation protection supervisor or medical physicist.
The sample collection method and technique
The sample collection method and technique selected should reduce the probability of
leakage, spills and sprays. Collection time, shielding and use of distance should also be
considered. All this should be covered in the risk assessment.
4.1
Labelling of samples
The relevant clinical details recorded on the label and the corresponding request form
must state that the sample is radioactive and specify the radionuclide.
The requesting clinician should ensure that appropriately labelled samples along with the
request forms are hand delivered to the testing laboratory - do not use the Airtube
delivery system for radioactive samples. Details of which patients samples are deemed to
be radioactive follow in section 5
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 6 of 12
4.2
Sample packaging
Extra care must be taken to minimise any risk of leakage to avoid causing radioactive
contamination at any stage in the sample’s journey. Standard Precautions (as mentioned
in section 2) must be followed.
4.3
Leaking samples
Any obviously leaking package must be separated immediately (using gloves) and the
radiation protection supervisor (RPS) or a senior member of the laboratory staff
contacted to take charge of the incident.
The senior person should contact the requesting doctor or a Nuclear Medicine Consultant
to determine whether the specimen is easily repeatable and decide whether the sample
should be discarded.
If it is identified to be necessary to test the specimen, then gloves must be worn and the
outside of the sample tube cleaned and decontaminated or the specimen transferred to a
clean, appropriately labelled, new tube/container following the procedures in the Local
Rules.
Care must be exercised to avoid clerical error on re-labelling. If the request form is
contaminated but readable, it should be carefully dried/wiped with a disposable paper
towel. It should then be placed into a plastic cover and photocopied. The original may
then be disposed into yellow plastic (clinical waste) disposal bags / containers for
incineration.
Normally a contaminated specimen will not be salvaged (due to the increased handling
risk), and a repeat specimen should be obtained if possible.
Any spillage onto the sample receipt bench area during unpacking should be
decontaminated following local procedures or Radiation Local Rules. Contaminated
packing materials and paper towelling used in decontamination must be dealt with as
detailed in local procedures or Radiation Local Rules. The surrounding area should then
be monitored in accordance with local procedures or Radiation Local Rules. If any
receiving departments do not have local procedures for work with radioactive material the
Radiation Safety Group (RSG) should be contacted to provide advice.
5
5.1
Specific advice for different patient groups
Nuclear medicine patients
Radionuclide therapy patients
In-Patients who have had a therapeutic administration wear a wristband with a yellow
insert which states what radionuclide they have had and what activity was administered.
Patients who have received a therapeutic administration as an outpatient will have been
given documentation detailing this information, with instructions to carry this information
with them for the period of time that any samples may be considered to be radioactive.
Samples must only be taken if clinically urgent. Radiation Local Rules and systems of
work must be followed. Advice from a Nuclear Medicine Consultant or a member of the
RSG should be sought prior to the taking of any biological samples from these patients.
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 7 of 12
Diagnostic nuclear medicine patients
Due to the type and level of radioactivity administered to these patients, most samples
from these patients will not come within the scope of this policy as they are unlikely to
cause significant radiation dose or risks from contamination. For patient groups that do
come within the scope of this policy, such as patients undergoing sentinel node biopsy,
specific policies and procedures have been developed. In the event of any other large
sample or tissue collection is taken on a Nuclear medicine patient advice should be
sought from Nuclear Medicine physics staff
5.2
Sealed source therapy (brachytherapy)
Radiotherapy Physics must be contacted when taking prostate or urine samples from
patients implanted with I-125 seeds into the prostate within 2 years of the implant date.
Samples may be radioactive due to the presence of active seeds or contamination
arising from a damaged seed. The correct procedure for dealing with the biological
sample will depend on a measurement of the surface dose rate (in accordance with the
Radiation Local Rules)
6
Activities above which precautions additional to "Standard
Precautions" may be necessary
The values tabulated in table 1 make the following assumptions;
Dose limitation is that for a member of the public i.e. not a radiation worker.
Samples are in containers.
Remote handling devices e.g. forceps are not used.
Number of samples handled is 5 per month.
Total exposure time, in direct contact with the sample(s), does not exceed 1 hr.
Interpretation of Table 1. The activity limits listed are for a single sample. If 5 such
samples at the activity limit are handled during 1 month the operator may achieve 1/12 th
of the annual skin/ extremity dose limit for a non-radiation worker (50 mSv). If higher
activity samples or more frequent sample handling occurs a risk assessment must be
performed. This may include environmental or personal radiation dose monitoring.
Activities below those listed in table 1 can be disregarded for the purposes of radiation
protection, provided that standard precautions are used and the assumptions, above, are
not contravened.
Precautions additional to "Standard Precautions" include labelling, shielding, handling,
storage, monitoring; and may be dependent on the results of risk assessment.
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 8 of 12
Table 1. Levels, above which, precautions additional to "Standard Precautions" may be necessary.
SPL
Standard
Precaution
Levels
Hydrogen-3
Carbon-14
Fluorine-18
Sodium-22
Phosphorus-32
Phosphorus-33
Sulphur-35
Chromium-51
Iron-59
Cobalt-57
Gallium-67
Selenium-75
Strontium-89
Strontium-90
Yttrium-90
Technetium-99m
Indium-111
Iodine-123
Iodine-125
Iodine-131
Samarium-153
Lutetium-177*
Rhenium-186
Thallium-201
Single sample
activity,
kBq
1000000
10000
289
155
35
100000
100000
9590
304
1000
1000
779
51
10
19
2354
683
1377
1000
737
1000
7003
1000
1000
Values in table 1 from IRR99; except where more stringent values have been calculated with the
assumptions listed above and using data from Delacroix et al., (* Delacroix data has been extrapolated
using data from “Barber, D.E., A.L Carsten, D.G.L. Kaurin, J.W. Baum. Doses to the Hand During
Administration of Radiolabeled Antibodies Containing Y-90, Tc 99m, I-131 and Lu-177”).
Risk assessment for each procedure must also include consideration of the following;
If the activity of a sample cannot be directly measured, e.g. samples taken outside
of normal office hours,
If the taking of a sample cannot be deferred, due to clinical need,
If multiple samples are required,
Changes in biological half-life.
Action to be taken in the above circumstances should be included in written procedures,
incorporated into contingency arrangements and included within local rules.
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 9 of 12
7
Radioactive organ and tissue samples
Radioactivity may concentrate in particular organs and tissues following administration of
unsealed sources of radionuclides. Such samples should be assumed to have
concentrated radioactivity. For patients undergoing brachytherapy, radioactive sources
may be administered to a particular organ or tissue.
Monitoring for radioactive contamination should be carried out with a suitable
contamination monitor before and after work with organs and tissue samples. Radiation
Local Rules and/or local procedures should contain all the safety precautions and
radiation levels to which staff should be able to work safely under (see Section 6 and 8
below).
The hazards are the same as those stated in section 3, Radiation hazards, i.e. external
radiation and internal radiation exposure; however, the risk arising from external radiation
is higher and therefore additional precautions need to be taken.
External radiation exposure:
Radiation doses arising from exposure to samples are likely to be small and well below
legal safety limits (but, as always, it is important to perform an adequate risk
assessment). In order to reduce radiation doses, samples should be stored within a
shielded container. The nature of the shielding required will vary according to the
radionuclide and activity. Advice on suitable shielding can be obtained from the RSG.
Where practicable, radiation dose may be minimised by reducing the handling time
and/or using forceps to increase the distance from the sample. If forceps are used, extra
care must be taken not to drop the samples.
Internal radiation exposure:
The risks from internal radiation are similar to those stated in section 3.
8
Radiation Local Rules and radiation risk assessments
Local rules must be available for all Radiation Controlled Areas of the trust.
It is recommended that Local Rules are also made available in those areas where there
is a potential for an increased radiation risk to staff and members of the public, including
examination rooms or theatres where radioactive samples are obtained from patients and
laboratories where samples are examined or stored.
The basis for each area’s local rules are on-going risk assessments and audits that
should be performed by senior staff and/or the RPS. A Medical Physicist or the Radiation
Protection Adviser (RPA) may assist or advise.
The Local Rules and radiation risk assessments must be reviewed regularly and
whenever new procedures or changes in procedure are implemented.
For advice on radiation safety including radiation risk assessments and Radiation Local
Rules see Section 9.
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 10 of 12
9
Radioactive waste
Radioactive waste materials must be disposed of in accordance with the Environmental
Permitting Regulations 2010. Departmental Radiation Local Rules provide detailed
information on radioactive waste disposal. Further advice can be sought from the
departmental RPS or the RSG. There is also a section on radioactive waste in the Trust
waste policy.
10 Advice on radiation safety
Radiation safety advice, including the preparation of Local Rules and radiation risk
assessments, can be obtained from the Nuclear Medicine Department, Radiotherapy
Physics or the Radiation Safety Group - depending on the origin of the sample.
The Radiation Protection Adviser is also available to provide advice.
Contact details:
Nuclear Medicine Physics
34795/33095
Radiotherapy Physics
33153
Radiation Safety Group (RSG)
35639
Nuclear Medicine Consultant
33215
Radioactive Waste Advisor
35679
Radiation Protection Adviser (RPA)
33759
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 11 of 12
11
References
Pathology Users Handbook, GEN MP 001 001.
http://freenet/Pathology/Doc/Path _Manual.pdf
The Haematology Handbook, RFHNST,
http://freenet/CACS/Haematology/doc/Haematologyhandbook.doc
Infection control – Standard precautions, RFHNHST, July 2008,
http://freenet/guidelines/775_Standard%20Precautions%20Final.doc
Infection Control – Specimen Collection, RFNHST, January 2006,
http://freenet.medsch.ucl.ac.uk/infectioncontroldocs/Policy%20for%20specimen%20c
ollection%20from%20wards.doc
Learoyd P A, Laboratory Health and Safety Information and Training Booklet, National
Blood Service, 2003/4,
http://www.blood.co.uk/hospitals/library/pdf/training_education/hs_train.pdf
Summary of Handling Radioactive Samples in labs (freenet)
Trust Waste policy
http://freenet.medsch.ucl.ac.uk/freenetcms/Default.aspx?&s=20&p=1350&m=1906
Environmental Permitting Regulations 2010,
The Ionising Radiations Regulations 1999, HMSO, 1999.
12
Arrangements for reviewing this policy
This policy is due for review by the Radiation Board in Jun 2015.
13
Policy authors
Jeff Jones, Principal Medical Physicist
Deborah Purfield, Principal Medical Physicist
John Agnew, Consultant Medical Physicist
Stephen Duck, Consultant Medical Physicist
14
Policy review
Jeff Jones, Principal Medical Physicist
Deborah Purfield, Principal Medical Physicist
Claire Skinner, Head of Radiological Physics and Radiation Safety
Danny McCool, Head of Nuclear Medicine
Neil Dancer, Head of Radiotherapy Physics
Dominic Dodd, chairman
David Sloman, chief executive
www.royalfree.nhs.uk
Page 12 of 12