Memorandum by the Royal College of Pathologists
The is a registered charity, bound by its
Royal Charter to promote and maintain the standard of service
in pathology for the benefit of patients and the general public.
It is not a trades union and it does not discuss the terms and
conditions of employment of its members.
The remit of the College is the whole of laboratory
medicine. This includes clinical microbiology, haematology (including
blood transfusion), clinical biochemistry, immunology, genetics,
histopathology, cytopathology and forensic pathology.
1. What the risks to patient safety are and
to what extent they are avoidable?
1. This response is limited to the context
of laboratory medicine, which we regard as the entire process
from the formulation of a diagnostic question and the decision
to use a laboratory test, through sampling, laboratory examination,
generation of the report and transmission of the report, to correct
interpretation and implementation of that report.
2. It is particularly important to view
laboratory medicine in this broad context because recent changes
in medical education have considerably reduced the training of
doctors in the use and interpretation of laboratory tests. Laboratory
staff are consequently seeing an increasing rate of requests for
advice from front-line clinical staff.
3. The commonest category of patient safety
incidents in laboratory medicine is specimen identification /
specimen tracking error. This has been most thoroughly documented
in the case of blood transfusion errors, which have received considerable
publicity; but it is undoubtedly more common in other aspects
of laboratory medicine.
4. The consequence of these errors is that
after a sample (eg of blood, urine, tissue etc) has been submitted
to the laboratory for analysis, the patient gets no report or,
worse still, the wrong report. The impact on patient safety can
include delayed or inappropriate diagnosis and treatment, with
the consequent possibility of serious morbidity and, rarely, death.
5. We believe that there should be greater
collaboration between laboratory staff and frontline clinical
staff in this area. At present, as is often the case with a handover
of responsibility, both tend to regard errors at the interface
as the responsibility of the other.
6. Specimen identification could be much
improved by the implementation of automatic patient / sample recognition
devices such as barcodes or RFID devices, preferably with tracking
systems linked to the patient database and the laboratory computer
systems. This is expensive, but implementation of the same technology
is relevant to many other patient identification issues such as
the correct dispensing of medicines, correct radiological investigations,
correct site surgery and the identification of the correct casenotes.
Barcodes are already widely used to facilitate more reliable specimen
identification within laboratories, but usually the barcode
is only generated after the specimen has been received by the
laboratory and it is not relevant to other hospital systems.
7. At present the NHS has not even managed
complete implementation of a single unique patient identifier
(ie the NHS number).
8. If laboratory investigations are linked
to single a hospital-wide "patient ID system", enforcing
utilisation of the patient's NHS number, there is potential for
cost saving as well as a decreased risk of sample identification
9. The related problem is at the other clinicianlaboratory
interface; the delivery, correct interpretation and implementation
of reports. There is much less research in this area, but there
is an abundance of anecdotal evidence relating to reports that
are generated by the laboratory but never translated into correct
10. We believe that IT systems need to be
developed that can allow sensible prioritisation of laboratory
reports, and which can on that basis demand acknowledgement from
frontline medical staff that critical reports have been received
11. This problem has been exacerbated by
recent changes in working practices and the reduction in junior
doctors' working hours, because the doctor who requests a test
and the doctor who must receive and interpret the result are now
often different individuals. There is a particular problem in
general practice, where the urgent delivery of critical results
after the GP surgery has closed has been the subject of joint
working between the RCPath and the RCGP. We are not convinced
that this problem has been satisfactorily resolved.
12. "Point of care testing" (POCT)
using small, sophisticated machines to generate laboratory results,
is a growing trend. These can be installed on wards, in GP surgeries,
in pharmacies and even in patient homes. The advantages in terms
of speed and convenience are obvious.
13. However, the risks are much less obvious.
Few doctors or pharmacists understand the quality control procedures
used by medical laboratories to ensure correct results. Furthermore,
POCT results tend to be used and discarded, thus losing the possibility
of comparison with subsequent results. If the results are fit
for purpose, they should surely be stored in the patient record.
14. IT solutions to this problem do exist,
in the form of links between POCT machines and laboratory databases.
These can automatically record results in the appropriate patient's
clinical record. They can also enforce appropriate scrutiny and
oversight by central laboratory personnel who are trained in the
necessary quality control procedures, allowing them to identify
individual operators or machines whose results appear to be discrepant.
Unfortunately the implementation of such safeguards is very far
15. There is a potential risk to patients
in the outsourcing of laboratory investigations, potentially to
inadequately trained staff or ill-equipped laboratories outside
the UK. This is not yet a major problem, but many laboratory specimens
are easily transportable and in some cases they can be transmitted
as digital images to anywhere in the world. There is therefore
a potential regulatory problem similar to that already recognised
in the interpretation of radiological images. Furthermore, if
laboratory analysis is outsourced in this way, the laboratory
service is degraded to a "results only" service. Not
only is there loss of control over quality assurance, but there
is loss of the interpretation and advice provided by current laboratory
services and there is, over time, a loss of training and physical
laboratory facilities, thus making a reversion to local service
provision impossible and destabilising the future provision of
16. These problems are well recognised in
the recent report by Lord Carter of Coles into the provision of
medical laboratory services in the UK, and we commend that report
to the Committee.
17. We believe that the outsourcing of laboratory
services may require an improved regulatory system in the future
if problems are to be avoided. We understand that this is already
being discussed at EU level in the context of other aspects of
medicine, notably radiology. The current implementation of medical
revalidation systems to all UK doctors should be applied to all
medical staff who treat NHS patients irrespective of their location,
or the implementation of these reforms will be perceived as a
2. What the current effectiveness is of the
following in ensuring patient safety?
18. We believe that none of these organisations
has an adequate understanding of the complex issues behind maintaining
a high quality laboratory service. Too often, the quality of a
laboratory service is measured only by the speed of delivery.
The production of accurate results is often naively assumed. The
need for advice on investigation and interpretation of results
(about 30% of current laboratory workload according to Lord Carter)
is often ignored. The need for training and sustainability of
the service is rarely considered.
3. What the NHS should do next regarding
19. The single greatest improvement in patient
safety in the area of laboratory medicine would be the implementation
of hospital-wide (or UK-wide?) automatic identification systems
(ie IT-linked barcodes and/or RFID devices), applicable to patients,
medicines, procedures and investigations including radiology and
laboratory investigations. Many commercial organisations have
implemented systems of this sort, including all major retail chains
and London Transport (ie. the "Oyster card" system).
Why not the NHS?