EXECUTIVE SUMMARY

  The Association for Clinical Biochemistry (ACB), founded in 1953, is a professional body dedicated to the practise and promotion of clinical science and laboratory medicine and has medical and non-medical members in all major UK healthcare laboratories, many university departments and several commercial companies. It was instrumental in establishing accreditation for clinical scientists in all disciplines and plays a significant role in the training of Clinical Scientists in the discipline of Clinical Biochemistry.

  Laboratory investigations play a significant role in some 70% of all clinical diagnoses and in the management of treatment for patients. The results of such investigations are therefore an essential element of the electronic patient record and will represent the bulk of the information stored in it.

  The Association recognises that the accuracy, reliability and repeatability of this information is essential for the safe and efficient use of electronic patient records. It also recognises the need for appropriate security mechanisms to protect the confidentiality and accuracy of any information stored in such records.

  The Association's evidence reflects those concerns. The evidence is generic in its nature in that it is relevant to all the scientific disciplines within clinical science and laboratory medicine that will contribute to the electronic record.

What patient information will be held on the new local and national electronic record systems, including whether patients may prevent their personal data being placed on systems

  From the perspective of Clinical Science and Laboratory Medicine the information stored needs to include:

—    Sufficient patient demographic information safely to identify a specific patient.

—    The results of investigations undertaken on that patient.

—    Relevant interpretive and diagnostic information.

—    Information identifying when, where and with what techniques any treatments and investigations were undertaken on the patient and with what outcomes.

  If the information is to be of value, and to avoid impairing patient safety, the information stored must be accurate, timely, consistent and reproducible. The information must be the full record. That is, ALL interventions and investigations, regardless of where they are carried out, must be included.

Who will have access to locally and nationally held information and under what circumstances

  Access to the information must be related to the sensitivity of the particular item as well as the role and responsibilities of the professionals being given access to it. This must take account of the need for Clinical Scientists to have access to sensitive data in order safely to supply interpretive information.

Whether patient confidentiality can be adequately protected

  A system of identifiers and passwords with sufficient flexibility to identify the roles and responsibilities of staff and the categories of information to which they should have access is required.

How data held on the new systems can and should be used for purposes other than the delivery of care eg clinical research

  A separate database for research could be established containing information derived from the electronic patient record but anonymised in such a way as to protect the confidentiality of the individual patients.

Current progress on the development of the NHS Care Records Service and the National Data Spine and why delivery of the new systems is up to twoars behind schedule

  A variety of factors may have contributed to this. Careful attention needs to be paid to the management of the project, in particular with respect to the operational requirements, assumptions and interdependencies, and the effects of central policy changes.

  The team managing the development and implementation needs adequate resources, including skills and experience commensurate with those available to the contractors.

INTRODUCTION

  1.  The Association for Clinical Biochemistry (ACB), founded in 1953, is a professional body dedicated to the practise and promotion of clinical science and laboratory medicine and has medical and non-medical members in all major UK healthcare laboratories, many university departments and several commercial companies. It has a relationship with the clinical diagnostics industry through links with its Corporate Members. The Association liaises with, and is consulted by, many national and international organisations on issues relating to Clinical Biochemistry. It was instrumental in establishing accreditation for clinical scientists in all disciplines. It also plays a significant role in the training of Clinical Scientists in the discipline of Clinical Biochemistry and its training framework is used by other disciplines.

  2.  The Association has long recognised and had experience of the value of electronic information management both in the support of the efficient operation of clinical laboratories and in the wider sense as an important tool for efficient, safe and secure storage of patient records as "electronic patient records". The added benefit of the ability rapidly to share electronic patient records across hospital and even national boundaries presents significant opportunities that may enhance patient treatment and care.

  3.  Our experience has been that the opportunities can only be exploited if surrounding issues are addressed, including:

—    Maintaining the accuracy of the information stored in the records.

—    Protecting confidentiality.

—    Ensuring that there is consistency in the structure of the information stored.

—    Ensuring that related types of information (such as test results) are comparable, regardless of where the investigations were carried out for both numerical and textual data.

—    Integrating information by recording all relevant observations regardless of where they are made; this would include clinical examinations as well as laboratory tests, physiological tests, imaging etc. Some diagnostic tests may be conducted outside the hospital and possibly outside health services premises (eg high street pharmacies, the patient's home, private laboratories, and so on.)

—    Ensuring completeness of the information stored. The value will be lost if the records are incomplete. Indeed, there is the risk of mistakes being made in the management of a patient if an element of information (such as episodes of care taking place in a hospital or laboratory not connected to the electronic record) is missing.

  4.  The results of clinical scientific investigations, such as laboratory tests, together with interpretive comments made by clinical scientists and laboratory doctors, make a significant contribution to some 70% or more of diagnostic and treatment decisions. They therefore play a vital role in the efficiency and cost effectiveness of the healthcare system and represent the bulk of the information stored in an electronic patient record.

  5.  The interpretive comments often include guidance on the appropriateness of testing which is important both in the avoidance of expenditure on unnecessary tests and recommending tests that identify when a particular treatment would be ineffective. The electronic record facilitates such guidance by bringing all the relevant information relating to a patient together.

  6.  Comprising as it does the majority of doctors and clinical scientists active in the clinical biochemistry discipline of laboratory medicine in the United Kingdom the Association is well placed to comment on those aspects of the electronic patient record.

  7.  The Association's evidence in this context is generic, in that it applies to other clinical science disciplines.

  8.  The assumption has been made in compiling this evidence that the inquiry relates to the UK "Connecting for Health" initiative and the Clinical Spine Application of that initiative in particular. The evidence is applicable throughout the UK.

What patient information will be held on the new local and national electronic record systems, including whether patients may prevent their personal data being placed on systems

  9.  There are many aspects of information relating to patients that might be included in an electronic patient record but are not of direct relevance to the test results derived from laboratory investigations. There are some items of patient information that need to be stored if the test results that are stored are to be used effectively and safely to manage patient care. These include:

—    Sufficient demographic information uniquely to identify a particular patient across all healthcare settings.

—    Chronological information between and within the episodes of care and investigations undergone by the patient.

—    Therapeutic (such as medications administered) and diagnostic (such as imaging) interventions made on the patient, and clinical diagnoses of conditions affecting the patient, as these may affect the results of laboratory investigations and their interpretation.

  10.  The question as to whether or not a patient should have the power to prevent personal data being included on electronic systems is one of ethics and personal freedom. But it must be borne in mind that if the elements of information referred to in paragraph 9 above are omitted from a record this would adversely affect the safety with which test results could be interpreted and may lead healthcare professionals to incorrect conclusions and inappropriate action.

Who will have access to locally and nationally held information and under what circumstances

  11.  Clinical Scientists require access to a level commensurate with interpreting a result leading to a diagnosis, advising on therapy etc. We need access to demographic data so that, for example, out of hours results that require urgent intervention can be more readily acted upon if the patient's telephone number is accessible.

  12.  While the Association recognises that patients must have the ability to restrict access to sensitive personal and diagnostic information it recognises equally that a Clinical Scientist must have the ability to gain access (through a suitably regulated and audited process) to gain access to such information where the safety of the patient demands it.

Whether patient confidentiality can be adequately protected

  13.  It may be argued that patient confidentiality can be better protected by electronic records than by paper records.

  14.  Appropriate identifiers for staff and levels of security are necessary. These need to be sufficiently flexible to allow specialist laboratory staff engaged in diagnostic and interpretive work to have access to sensitive information that would not be required by staff undertaking solely analytical work. The electronic record must also recognise that some laboratory data such as HIV status, pregnancy tests and drug abuse screens are highly sensitive.

How data held on the new systems can and should be used for purposes other than the delivery of care eg clinical research

  15.  The new systems will contain a wealth of information in a highly accessible and usable form. The information has the potential to be a valuable source of material for epidemiological and other studies that could be valuable for future treatment and planning of services for patients.

  16.  The Association would therefore encourage the harvesting of anonymised data to be made available for authorised research purposes, with the following two provisos:

—    Such use must not breach the security or confidentiality of individual patient information.

—    The quality (consistency, accuracy, repeatability and so on) of the information from all sources contributing to the electronic records must be assured. Otherwise there would be a significant danger of inaccurate predictions being made, or conclusions drawn, during research making use of the information.

Current progress on the development of the NHS Care Records Service and the National Data Spine and why delivery of the new systems is up to two years behind schedule

  17.  The Association's observations on this include.

  18.  There has been some question of the requirements of practitioners within the Health Service having been inadequately canvassed and reviewed at the outset leading to delays as unanticipated requirements come to light.

  19.  The scale of the initiative is such that requirements can change throughout the period of design and implementation. The changes may occur due to developments in technology, treatment and care. They may also result from changes in policy regarding the delivery and scope of health care and the organisational structures responsible for delivery.

  20.  There is a perception that delivery and implementation have been poorly planned, notably in the area of "Anglicisation" of software originating from outside the UK NHS healthcare context, that have consumed considerable time from practitioners. Better preparation centrally could eliminate such delays at the point of delivery.

  21.  The skills, quality and experience of the internal representatives managing the development and implementation need to match those of the external contractors.

  22.  Interdependencies and assumptions need to be carefully managed. The Carter Report, [32]for example, makes the assumption that the developments in "Connecting for Health" will facilitate the proposed "network" approach to delivery of pathology services. It is not clear how such a requirement will be conveyed to the connecting for health implementation.

  23.  Engagement of coal-face clinical practitioners in detailed design and functionality that they need to "work smarter" and the willingness of providers to recognise their issues has been very variable across CfH Clusters. If that approach continues it will inevitably compromise the clinical, operational and financial cost-benefits realisation.

The Association for Clinical Biochemistry

March 2007