Select Committee on Health Written Evidence

Memorandum by the Royal College of Pathologists (PS 66)


  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 error.

  9.  The related problem is at the other clinician—laboratory 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 patient care.

  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 and understood.

  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 from routine.

  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 the service.

  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 sham.

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 patient safety?

  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?

September 2008

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