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    The Royal College of Pathologists

    NHS clinical biochemistryA profession under siege

    A report on consultant staffing in NHS clinical biochemistry

    from the Task Force established by the

    Association of Clinical Biochemists (ACB) and

    The Royal College of Pathologists (RCPath)

    May 2002

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    Association of Clinical Biochemists The Royal College of Pathologists130132 Tooley Street 2 Carlton House TerraceLondon LondonSE1 2TU SW1Y 5AF

    Registered charity no. 261035

    www.acb.org.uk www.rcpath.org

    2002 The Royal College of Pathologists

    Further copies of this publication can be obtained from the ACB and College websites

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    NHS clinical biochemistry

    A profession under siege

    CONTENTS

    Foreword.............................................................................................................................................. 1

    1 Executive summary and recommendations................................................................................. 2

    1.1 Introduction....................................................................................................................... 2

    1.2 Executive summary............................................................................................................ 21.3 Recommendations ............................................................................................................. 5

    2 Introduction................................................................................................................................ 7

    2.1 Background to study.......................................................................................................... 7

    2.2 Remit of Task Force.......................................................................................................... 7

    2.3 Method of working ........................................................................................................... 72.3.1 Review of publications2.3.2 Analysis of membership databases2.3.3 Benchmarking2.3.4 Open workshop

    2.3.5 Questionnaire to consultants2.3.6 Questionnaire to chief executives

    2.4 Response rate from consultant questionnaire.................................................................... 82.4.1 Return rate2.4.2 Demographics of responding departments2.4.3 Demographics of responding consultants

    2.5 Response rate from chief executive questionnaire............................................................. 92.5.1 Return rate2.5.2 Analysis of respondents

    3 Workload in clinical biochemistry ............................................................................................ 10

    3.1 Departmental workload................................................................................................... 103.1.1 Total workload3.1.2 Out of hours workload3.1.3 GP workload3.1.4 Repertoire

    3.2 Consultant workload....................................................................................................... 103.2.1 Hours worked3.2.2 Out of hours3.2.3 Typical working week3.2.4 Origin of clinical work3.2.5 Origin of non-clinical work3.2.6 Secretarial support

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    4 Staffing in clinical biochemistry ............................................................................................ 14

    4.1 Total staffing................................................................................................................... 144.1.1 Medical staffing

    4.1.2 Clinical scientist staffing4.1.3 Biomedical scientist staffing4.1.4 Other staff

    4.2 Consultant staffing .......................................................................................................... 144.2.1 Total consultant staffing4.2.2 Medical consultant staffing4.2.3 Clinical scientist consultant staffing4.2.4 Consultant staffing and demographics

    4.3 Audit of minimum senior staffing model......................................................................... 16

    5 Pressures in clinical biochemistry.............................................................................................. 18

    5.1 Clinical governance pressures.......................................................................................... 185.1.1 Laboratory accreditation5.1.2 Turnaround times5.1.3 External quality assurance5.1.4 Blunders5.1.5 Meeting clinical governance targets

    5.2 Laboratory pressures....................................................................................................... 215.2.1 Workload and staffing5.2.2 Scientific and technical workforce5.2.3 Clinical demand5.2.4 National service frameworks

    5.3 Consultant pressures........................................................................................................ 23

    5.3.1 Stress assessment5.3.2 Absence cover5.3.3 Research and development and scientific publications5.3.4 Planned age of retirement5.3.5 Workforce planning5.3.6 Consultant staffing assessment

    6 Changing practice in clinical biochemistry................................................................................ 28

    6.1 Introduction..................................................................................................................... 28

    6.2 Changing laboratory practice.......................................................................................... 286.2.1 Pre-analytical and analytical functions

    6.2.2 Post-analytical practices6.3 Changing consultant practice .......................................................................................... 29

    6.3.1 Multi-site working6.3.2 Changing consultant functions6.3.3 Perceived need for additional consultant functions ........................................... 306.3.4 Metabolic medicine

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    7 Action plan for clinical biochemistry........................................................................................ 33

    7.1 Priority areas for action................................................................................................... 33

    7.2 Consultant staffing .......................................................................................................... 33

    7.2.1 Medical consultants7.2.2 Consultant clinical scientists

    7.3 Model to predict the number of consultants in clinical biochemistry.............................. 347.3.1 Assessing the need for and basis of the model7.3.2 A model to predict the number of consultants in clinical biochemistry7.3.3 Validation of the model7.3.4 Implementation of the consultant staffing model

    7.4 Non-consultant staffing................................................................................................... 387.4.1 Trainee medical and clinical scientist staff7.4.2 Grade B clinical scientists7.4.3 Biomedical scientists

    7.4.4 Medical laboratory assistants and administrative and clerical staff7.5 Publicity and promotion of the Task Force report.......................................................... 40

    7.5.1 Consultation document7.5.2 Final report7.5.3 Executive summary and recommendations7.5.4 Promotion of the findings of the Task Force

    7.6 Review of progress with the Task Force recommendations............................................. 41

    8 Feedback from senior Trust management................................................................................. 42

    8.1 Introduction..................................................................................................................... 42

    8.2 Workload in clinical biochemistry................................................................................... 42

    8.3 Staffing in clinical biochemistry....................................................................................... 42

    8.4 Pressures in clinical biochemistry .................................................................................... 43

    8.5 Changing practice in clinical biochemistry...................................................................... 45

    8.6 Summary of feedback from senior Trust management.................................................... 47

    9 References................................................................................................................................. 48

    10 Acknowledgements................................................................................................................... 50

    11 Appendices................................................................................................................................ 51

    A1 Membership of the joint ACB/RCPath Task Force.......................................................... 51A2 Consultant questionnaire................................................................................................. 52

    A3 Freehand comments on consultant questionnaire............................................................ 63A3.1 Part 1 departmental comments........................................................................ 63

    A3.2 Part 2 consultant comments............................................................................ 65

    A4 Chief executive questionnaire.......................................................................................... 70

    A5 Freehand comments on chief executive questionnaire ..................................................... 74

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    1

    FOREWORD

    Dear Reader,

    This report contains the results of a comprehensive study of consultant staffing in NHS clinicalbiochemistry, which was commissioned jointly by the Association of Clinical Biochemists (ACB) andthe Royal College of Pathologists (RCPath). The main findings of the report are of a large increase inboth the quantity and complexity of workload over the past five years, with no increase in consultantstaffing. NHS clinical biochemistry truly is a profession under siege.

    The ACB and RCPath recognise that 2002 is a time of great change in health care, and especially inlaboratory medicine. Although evidence of the impact of this change is only now beginning toaccumulate, the recommendations in the report have been designed to be capable of implementation in

    this changed environment, enabling the new NHS to maintain modern, responsive and high-qualityclinical biochemistry services which are matched to the needs of the patient.

    At national level, the introduction of national service frameworks and managed clinical networks needto be accommodated. The NHS Plan challenges us to look closely at the roles of medical practitionersand Making the Change offers the prospect of an integrated team of healthcare scientists, many ofwhom work in clinical biochemistry laboratories.

    At NHS Trust level, the introduction of the new strategic health authorities in England calls forflexible but comprehensive service provision and staffing for populations of around 1.5 million. Aspart of this reconfiguration, there is a substantial programme of pathology modernisation whichclinical biochemists are helping to lead. A properly staffed and consultant-led service is essential to

    deliver the improvements envisaged by the modernisation programme.

    Within clinical biochemistry itself, the pattern of requesting is changing and there is greater emphasison quality standards necessary to ensure proper clinical governance, including interpretation andclinical guidelines. The new sub-specialty of metabolic medicine will also have a major impact on therole of medical consultants in clinical biochemistry.

    The ACB and RCPath are keen to work with the four Departments of Health, Strategic HealthAuthorities and their Workforce Development Confederations, NHS Trusts (including Primary CareTrusts) and other professional bodies to implement the recommendations in the report, in the firmbelief that these will deliver the clinical biochemistry services that the NHS and the patient will requirein the years ahead. We hope that you find the report informative and useful.

    Yours sincerely,

    Professor John S Lilleyman Professor Alan ShenkinPresident, RCPath President, ACB

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    1 EXECUTIVE SUMMARY AND RECOMMENDATIONS

    1.1 Introduction

    This report was prepared by a Task Force established jointly by the Association of ClinicalBiochemists (ACB) and the Royal College of Pathologists (RCPath), in response to theconcerns of their members about the growing pressures on consultants in clinicalbiochemistry and their impact on quality, risk management and the ability to meet clinicalgovernance targets for the patient, the service and the profession. The Task Force wasestablished in February 2001 with the following remit: to produce an evidence based reportwhich recommends the optimal number of consultant level staff currently required for NHSclinical biochemistry departments in the UK, together with a model which may be used topredict future consultant staffing requirements.

    The Task Force consulted widely in its work. An essential part of the investigation was thepreparation of a detailed questionnaire, which was distributed to every consultant in an NHSclinical biochemistry department.

    A second questionnaire was distributed to every NHS Trust Chief Executive, in order toprovide initial information and seek the views of senior NHS managers about the currentstate of clinical biochemistry.

    A summary of the main findings of the Task Force is given in Section 1.2. The specificrecommendations arising out of the work of the Task Force are given in Section 1.3.

    The full report, together with all the evidence to underpin the findings and justify the

    recommendations, is available from the ACB and RCPath, most conveniently from theirwebsites: www.acb.org.uk and www.rcpath.org.

    1.2 Executive summary

    1.2.1 The workload of clinical biochemistry departments increased by 56% (requests) and 63%(tests) over the period 19952001. On average, clinical biochemistry departments processed331 000 requests and 1 839 000 tests in the year to 31 March 2001. Not only did the totalworkload rise, but the percentage of that workload delivered outside normal working hoursalso rose from 8.7% to 13.4% over the same period. General practitioners now provide thegreatest contribution to the workload, with this share rising from 30.9% in 1995 to 36.7%

    in 2001. The repertoire also increased between 1995 and 2001, with an average of tenadditional analytes available within normal working hours and 6.5 analytes out of hours.Although there are important differences between district general hospitals and teachinghospitals, the same major trends are evident.

    1.2.2 The number of staff working in clinical biochemistry departments has declined during theperiod 19952001. The number of consultant staff has remained static, whilst the number ofgrade B clinical scientists and specialist registrars has each fallen by approximately 10%. Thenumber of biomedical scientists in post has also declined, in part due to the difficulties ofrecruitment and retention.

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    1.2.3 The net effect of a rising workload and falling staff is increased pressure and stress withinclinical biochemistry departments, with consultants having to absorb the managementconsequences of this additional burden. In 1995, 82% of departments considered their totalstaffing to be adequate or better, but by 2001, 89% of departments were struggling to cope.Unless a solution is found, 98% of departments will either be struggling or unable to cope by2005.

    1.2.4 Against a general background of improving quality standards, early signs of problems may bedetected in areas such as laboratory accreditation, performance in external quality assessmentschemes, turnaround time and blunder rates. Consultants have significantly less confidence inmeeting clinical governance targets than they did in 1995.

    1.2.5 All the evidence indicates that the workload of clinical biochemistry laboratories willcontinue to rise in line with the growing number of general practitioners and hospitalconsultants and the extended roles of other healthcare professionals. Moreover, national

    service frameworks for diabetes mellitus, coronary heart disease and cancer are expected toincrease workload by a further 10%.

    1.2.6 Many Trusts and departments have introduced a range of measures to try to cope with therising workload. Automation and information technology have had some impact, especiallyon the pre-analytical and analytical components of the work but, in general, they have failedto keep pace with the rising workload. In the post-analytical phase of operation, departmentshave been forced to introduce steps to manage the interpretation and reporting functions,often against their better judgement.

    1.2.7 Clinical biochemistry is a consultant-led service. Those consultants work long hours. Onaverage, NHS medical consultants work 47.3 hours each week (excluding on-call cover),

    with more than 35% of them regularly working in excess of the 48-hour maximum workingweek as defined by the European Working Time Directive. Consultant clinical scientists anduniversity medical consultants work similar hours. In addition, NHS medical consultants areon-call for an average of 52 hours each week, with the figures for the other consultant gradesbeing only slightly less demanding. In total, more than 115 UK consultants in clinicalbiochemistry provide a 24-hour, seven-day, single-handed advisory service in addition totheir long working week.

    1.2.8 On average, a consultant in clinical biochemistry is now responsible for reporting 630requests and 3500 test results on each normal working day. There are real concerns,supported by the Clinical Benchmarking Company, that this workload is too high toguarantee proper clinical guidance to users of the service and especially to general

    practitioners.

    1.2.9 The recent accreditation of the sub-specialty of metabolic medicine will improve the qualityof clinical care in this developing field of medicine. The development is generally welcomewithin the profession, but it will generate new work, significantly reduce the amount of timethat accredited medical consultants in clinical biochemistry are able to give to laboratoryrelated functions and thereby increase pressure on them and other senior staff.

    1.2.10 Whilst the clinical demands of the consultant in clinical biochemistry have increased in linewith the workload, there has been an even greater increase in the amount of time spent onquality issues (laboratory accreditation, audit, risk management, clinical governance, etc.)and on management within the department and Trust. Research and development has

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    suffered badly and is now almost non-existent in many NHS non-teaching hospitaldepartments.

    1.2.11 Evidence from job plans indicates that the roles of medical consultants and consultant clinicalscientists are complementary, with overlapping functions in areas such as reporting, qualitymatters and management. Medical consultants will normally undertake some aspects ofdirect clinical care and give advice on patient management; this role is likely to grow as thesub-specialty of metabolic medicine evolves. Consultant clinical scientists generally areinvolved in more laboratory-based functions, including research and development. Thedecision on whether to appoint a medical consultant or a consultant clinical scientist shouldbe a local one, based on the detailed duties to be undertaken and the existing staff in post.

    1.2.12 Consultants in clinical biochemistry have seen their stress at work increase appreciablyduring the past six years, with 36% now admitting to severe stress during the normalworking day.

    1.2.13 An additional 78 medical consultants and 70 consultant clinical scientists are required inclinical biochemistry departments. Whilst these posts are required to meet the deficitidentified in 2001, it is recognised that there will have to be a significant lag phase beforesufficient staff can be recruited and trained. Workforce planning is required to recruit thenecessary additional specialist registrars over a suggested five to six-year period. The problemfor clinical scientists is considerably greater because current trainee recruitment is onlysufficient to meet 50% of the existing need, and a large increase will be required to meet theadditional number of grade B clinical scientists and consultant clinical scientists identified bythe Task Force. Therefore an eight-year period seems a more practical target within which toexpand the recruitment and training of grade A clinical scientists.

    1.2.14 There is also an urgent need to increase other grades of staff in clinical biochemistrydepartments. In 2001, it has been estimated that 88%, 51% and 49% of departments requireadditional biomedical scientists, medical laboratory assistants, and administrative and clericalstaff respectively. A total of 100 grade B clinical scientists require to be recruited to replacethose lost through gradual attrition at NHS Trust level.

    1.2.15 A detailed model for assessing the number of consultants in a clinical biochemistrydepartment has been developed and validated. This model acknowledges the impact ofworkload volume and complexity, the problems of single -handed working and maximumworking time and the need for flexibility in the pattern of service delivery, includingoperation across sites.

    1.2.16 NHS Trust Chief Executives were sent an information sheet of the main findings of the TaskForce and their reactions were sought through a short survey. The senior managers whoreplied were split over whether clinical biochemistry is a clinical service or a clinical supportservice. In general, they are very happy with the overall quality of service but 25% admit thatthe clinical biochemistry services are deteriorating in their Trust.

    1.2.17 A majority of the senior managers recognise all or most of the findings in the informationsheet and they acknowledge the pressures that exist in clinical biochemistry. A majority agreethat departments are struggling to cope with current staffing levels and shortages areacknowledged to varying extents in all staff grades.

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    1.2.18 NHS Trusts have clearly invested substantially in automation and information technologyduring the past five years, in an effort to manage the rapidly rising workload. Some 74% ofsenior managers agree that laboratories in their Trust have been targeted for savings andvirtually all of them have seen an improvement in the cost-effectiveness of their clinicalbiochemistry services.

    1.2.19 Trust managers agree that a wide range of consultant duties in clinical biochemistry willincrease in the next four years, with 76% expecting service reconfiguration and 91%expecting extra work related to compliance with clinical governance targets.

    1.2.20 Overall, senior managers recognise the range of pressures in clinical biochemistry and see theneed for additional staffing, including consultant staffing. Predictably, perhaps, they do notview the problems quite so seriously as the consultants in clinical biochemistry on averagemanagers see problems to an extent of about two-thirds of that of their consultants.

    1.2.21 Senior Trust managers estimate that approximately 100 additional consultants will berequired in clinical biochemistry over the next four years.

    1.3 Recommendations

    1.3.1 It is recommended that the number of medical consultants in clinical biochemistry beincreased by 78 whole time equivalents (wte) to meet the current needs of the profession andthe introduction of metabolic medicine.

    1.3.2 It is recommended that the expansion of 78 specialist registrars in clinical biochemistry(national training numbers) be achieved by a planned increase of 26 per year, for each of the

    next three years.

    1.3.3 An expansion of 70 consultant clinical scientist posts is recommended to meet current needs.In addition, the appointment of 100 principal grade clinical scientists is required to replacelost posts.

    1.3.4 It is recommended that the number of grade A clinical scientist posts must be matched to thecurrently identified workforce planning needs and then further expanded by 22 posts peryear for the next eight years.

    1.3.5 It is recommended that, as a matter of urgency, the ACB prepare a detailed paper on theworkforce requirements for clinical scientists, which it presents to all relevant national and

    regional workforce confederations.

    1.3.6 The following six-step model is recommended as the basis for determining consultant staffingin NHS departments of clinical biochemistry.

    (i) Each department should have a minimum of 1.5 wte consultant staff.

    (ii) Add 0.1 wte consultant for each increment of 25 000 requests per year above a baselineof 200 000.

    (iii) Add 0.5 wte consultant for each department that operates from more than onesubstantial geographical site.

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    2 INTRODUCTION

    2.1 Background to study

    The ACB/RCPath Task Force to examine consultant staffing in NHS clinical biochemistrywas established in response to growing concerns within the profession that a combination ofincreasing workload and other pressures was already compromising the quality of the servicebeing offered, and that the situation was likely to deteriorate still further in the future. Manyconcerns had been expressed, including:

    increasing workload without increases in staffing

    the demand for ever-higher quality standards of practice

    the changing role of consultants in clinical biochemistry

    consultants working excessive hours under growing pressure

    an ageing profession without adequate workforce planning

    a looming crisis in being able to sustain clinical governance targets.

    Consequently, the Task Force was jointly established in February 2001 by the Council of theACB and the Specialty Advisory Committee on Clinical Biochemistry of the RCPath. Themembership of the Task Force is recorded in Appendix 1.

    2.2 Remit of the Task Force

    The remit of the Task Force was defined as follows: to produce an evidence-based reportwhich recommends the optimal number of consultant level staff currently required for NHS

    clinical biochemistry departments in the UK, together with a model which may be used topredict future consultant staffing requirements.

    2.3 Method of working

    The Task Force adopted a broad approach to gathering evidence prior to the analysis phaseof it work.

    2.3.1 Review of publicationsThe Task Force obtained and examined two types of publication. First, it sought publicationsfrom the scientific literature on workload, staffing, changing practice and pressures in clinical

    biochemistry. Second, it obtained copies of relevant government publications and reportsfrom other specialties of pathology and laboratory medicine that addressed similar topics.These publications are referred to in the text and recorded in Chapter 9.

    2.3.2 Analysis of membership databasesThe Task Force had access to the membership databases of both the ACB and RCPath.

    2.3.3 BenchmarkingThe Task Force was granted permission to use the cumulative data collected by the ClinicalBenchmarking Company and the University of Keele (CBC). Clinical Pathology Accreditation(UK) Ltd (CPA) and the UK National External Quality Assessment Scheme for ClinicalChemistry (UK NEQAS) also supplied the Task Force with relevant data.

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    2.3.4 Open workshopThe Task Force organised an open workshop, which was held in London during Focus 2001and attended by more than 100 senior members of the profession. The workshop sought toengage the profession in the work of the Task Force, gather relevant evidence, and influencethe content of the studies undertaken.

    2.3.5 Questionnaire to consultantsThe Task Force used the information obtained from the sources described in paragraphs2.3.12.3.4 to prepare a questionnaire to gather evidence related to its remit from consultantsworking in NHS clinical biochemistry in the UK. The questionnaire sought specific data andopinion on changes in practice between the years of 19941995 and 20002001, a relativelyshort period chosen to coincide with the time during which the concerns of the professionhave emerged. This questionnaire was divided into two parts: Part 1 sought evidence relatingto the department in which the consultant worked and only one return per department was

    analysed; Part 2 sought evidence relating to the work of the individual consultant and allreturns were analysed. A copy of this questionnaire is included as Appendix 2.

    2.3.6 Questionnaire to chief executivesOnce the consultant questionnaire had been analysed the Task Force designed a shortquestionnaire for circulation to chief executive officers (CEOs) of NHS Trusts. The purposeof this questionnaire was to establish whether senior managers recognised the mainconclusions from the consultant questionnaire in their own environment. A copy of thisquestionnaire is included as Appendix 4.

    2.4 Response rate from consultant questionnaire

    2.4.1 Return rateThe addresses of all consultants working in clinical biochemistry in the NHS were compiledfrom lists supplied by the regional representatives to the Council of the ACB and verified bycomparison with the ACB and RCPath membership databases. A total of 414 questionnaireswere distributed to consultants working in 242 departments. Overall, returns were receivedfrom 74% of departments and 64% of individual consultants. Unless otherwise stated, thedata from these returns provides the evidence presented in subsequent chapters of this report.

    2.4.2 Demographics of responding departmentsA summary of the responses received from the departments is shown in Table 1. Prior todistribution of the questionnaire it was recognised that changes in NHS Trust structure would

    have affected the number and size of several departments in the period 19952001.Therefore, respondents were asked to return like-for-like data (based on the 1995 structure)together with information on any changes in structure in the intervening period. In a smallnumber of cases comparative data was not available.

    2.4.3 Demographics of responding consultantsA summary of the responses received from individual consultants is included in Table 2. Ithad been anticipated that not all consultants would be able to answer all the points in Part 2of the questionnaire. For example, recently appointed consultants would not be able toanswer questions comparing their roles in 1995 and 2001, and consultants employed byuniversities with part-time roles within the NHS would find some questions irrelevant.Therefore, individuals were invited only to complete those sections that they felt comfortable

    to answer. All returned data was included in the analysis.

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    Table 1 Analysis of departmental responses to consultant questionnaire

    Nature of hospital Distributed Returned %

    Teaching hospital 59 45 76District general hospital 169 122 72

    Childrens hospital 9 9 100

    Specialist unit 5 4 80

    Total 242 180 74

    Region Distributed Returned %

    Northern and Yorkshire 25 15 60

    Trent 16 14 87

    South East (incl London) 84 53 63

    South West 21 17 81West Midlands 22 17 77

    North West 27 25 93

    Wales 14 14 100

    Scotland 25 19 76

    Northern Ireland 8 6 75

    Total 242 180 74

    Table 2 Analysis of individual responses to consultant questionnaire

    Consultant category Distributed Returned %

    NHS medical consultant 172 106 62

    NHS consultant clinical scientist 95 131 67

    University medical consultant 30 18 60

    University non-medical consultant 17 9 53

    Total 414 264 64

    2.5 Response rate from chief executive questionnaire

    2.5.1 Return rate

    The Departments of Health in England, Northern Ireland, Scotland and Wales supplied thenames and addresses of the chief executive officers of 229 acute hospitals NHS Trusts. Each ofthese was sent the information sheet and survey (Appendix 4). A total of 129 returns werereceived by the closing date of 30 November 2001. This represents a 56% return rate. Afurther 10 returns arrived after the closing date; these were not analysed but their inclusion asreturns yield an overall return rate of 61%.

    2.5.2 Analysis of respondentsThe CEO was invited either to complete the survey or to pass it to an appropriate seniormanager for completion. In the event the returns were received from 19 chief executives (15%),17 medical directors (13%), 45 senior Trust managers (35%), 42 clinical directors oflaboratory medicine (33%) and 6 others (4%).

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    3 WORKLOAD IN CLINICAL BIOCHEMISTRY

    3.1 Departmental workload

    3.1.1 Total workloadData from Scotland has revealed a 54% increase in the number of clinical biochemistry testsundertaken by NHS laboratories in the five-year period from 19941995 to 19992000.1

    Data from CBC revealed an increase of 52.7% in the number of requests performed byparticipating UK clinical biochemistry laboratories over the same period.2 A summary of theevidence obtained from the consultant questionnaire is included in Table 3 and this revealsdata that is very much in line with these published trends. Overall, the total number ofrequests increased by 56% between 1995 and 2001, whilst the number of tests increased by63% over the same period. The increase was similar in district general hospital (DGH) andteaching hospital departments but significantly lower in childrens hospital departments.

    3.1.2 Out of hours workloadNot only have clinical biochemistry departments experienced a dramatic rise in totalworkload in recent years but the proportion of that workload which arrives outside thenormal working day (defined as the period with maximum staffing) has also increased from8.7% to 13.4% (Table 3). This 54% increase almost certainly underestimates the trendtowards around the clock services since 52 departments have extended their normalworking day during the period under study (see Chapter 6.1.1). A similar finding of a 64%increase in the out of hours workload over a five year period is available from Scotland. 1

    3.1.3 General practitioner workloadThe percentage of the total workload originating from general practitioners (GPs) rose from

    30.9% to 36.7% in the six-year study period (Table 3). In absolute terms, GP requestsincreased by 85%, and were the most rapidly growing component of the clinical biochemistryworkload. For DGH departments, GP requests now represent 42.3% of the total workload,the corresponding figure for teaching hospital departments is 27.2%. It is widely acceptedthat requests originating from GPs require more input from consultants and other interpretivestaff at the post-analytical stage than work originating within the hospital.

    3.1.4 RepertoireNot only has the volume of the workload of clinical biochemistry laboratories increaseddramatically, but the repertoire offered has also increased. Within the normal working day,94% of respondent departments have seen an increase in repertoire during the past six yearswith a mean increase of 10 analytes. In 87% of laboratories the repertoire has also increasedout of hours, by a mean of 6.5 analytes, reflecting the strong move towards more around theclock clinical biochemistry.

    3.2 Consultant workload

    Four categories of consultant staff work in NHS clinical biochemistry departments (Table 2).The Task Force agreed that it would be much more informative to analyse the volume andnature of the consultant workload by category rather than in total. In one category (universitynon-medical consultant), there were few returns and so this category was omitted fromfurther analysis.

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    Table 3 Workload of clinical biochemistry departments

    3.2.1 Hours worked

    3.2.1.1 NHS medical consultants who are employed full time work an average of 47.3 hours perweek (excluding out of hours cover), an average of 8.8 hours above the 38.5h (11 sessions)that a whole time employee is contracted to work. At least 35% of individuals work anaverage in excess of the 48 hours stipulated by the European Working Time Directive 3 before any allowance is made for out of hours working. Since 1995, 83% of this category ofconsultant has experienced an increase in the average working week, whilst 14% have seenno change and 3% have seen a decline.

    3.2.1.2 NHS consultant clinical scientists work an average of 46.7 hours per week (excluding out ofhours cover), an average of 9.7 hours above the 37 hours that a whole time employee isnominally contracted to work. At least 32% of consultants work an average in excess of the48 hours stipulated by the European Working Time Directive3 before any allowance is madefor out of hours working. Since 1995 66% of this category of consultant has experienced anincrease in the average working week, whilst 26% have seen no change and 8% have seen adecline.

    3.2.1.3 University medical consultants (with honorary NHS consultant contracts) work an average of48.7 hours per week in total. At least 55% work an average in excess of the 48 hoursstipulated by the European Working Time Directive 3 before any allowance is made for outof hours working. Since 1995 59% of this category of consultant has experienced an increasein the average working week, whilst 29% have seen no change and 12% have experienced adecline.

    Average departmental workload 1995 2001 % change

    Requests (1000s) all departments 212 331 56Tests (1000s) all departments 1128 1839 63

    Out of hours (% total) all departments 8.7 13.4 54

    GP origin (% total) all departments 30.9 36.7 19

    Requests (1000s) teaching 332 522 57

    Tests (1000s) teaching 1824 2882 58

    Out of hours (% total) teaching 8.7 14.5 65

    GP origin (% total) teaching 20.5 27.7 35

    Requests (1000s) DGH 169 263 56

    Tests (1000s) DGH 917 1546 68

    Out of hours (% total) DGH 8.4 12.6 50GP origin (% total) DGH 36.3 42.3 16

    Requests (1000s) childrens 110 149 35

    Tests (1000s) childrens 427 539 26

    Out of hours (% total) childrens 13.9 21.1 52

    GP origin (% total) childrens

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    3.2.2 Out of hours working

    3.2.2.1 NHS medical consultants are on-duty out of normal working hours for an average of 52hours per week. Of these consultants, 31% are available for contact 24 hours per day, 7 daysper week, 52 weeks per year (excluding holidays). The actual number of calls received and thehours spent in the department vary considerably within this group.

    3.2.2.2 NHS consultant clinical scientists are on-duty out of normal working hours for an average of41 hours per week. Of these consultants, 19% provide total out of hours cover. As with theprevious category of consultant, the actual number of calls received and the hours spent in thedepartment vary considerably within this group.

    3.2.2.3 University medical consultants are on-duty out of normal working hours for an average of 13hours per week. Once more, the actual number of calls received and the hours spent in thedepartment vary considerably within this group.

    3.2.3 Typical working weekThe typical working week of each of the three categories of consultant was derived from themean of the figures provided and is shown in Table 4. As may have been anticipated, themedically qualified consultants spend more time on direct patient care than their non-medicalcounterparts who, in turn, spend more time on validation of results, providing scientificinsight and departmental management. Predictably, university employees spend more timeteaching and on research and development than their colleagues employed by the NHS. Asub-analysis of the information returned indicates that NHS employed consultants in teachinghospital departments, spend more time on teaching and research and development than theircolleagues from DGH departments, who spend correspondingly more time on management-related tasks (data not shown). It should be stressed that the job functions of each consultant

    differ in order to meet the needs of the specific post. Therefore, the breakdown of jobfunctions for an individual consultant may differ significantly from the mean data shown inTable 4.

    3.2.4 Origin of clinical workThe percentage work for each consultant category that originates from GPs and variousclinical teams within the hospital is shown in Table 5. Childrens hospital departments andspecialist units have been excluded from this analysis. It is clear that GPs generate the biggestcomponent of clinical work for NHS employed consultants. This finding is most pronouncedfor consultants working in DGH departments (Table 3).

    3.2.5 Origin of non-clinical work

    It may have been expected that the rapidly rising and expanding workload demonstrated inparagraph 3.1 would have resulted in consultants spending more of their time on thisfunction. However, it is clear from Table 4 that in 2001 work directly related to clinicalfunctions accounts for 50% at most of consultant time with management related functionsaccounting for the remainder. As will be demonstrated in Chapter 6, the proportion of timebeing spent on management functions has increased during the past six years, despite the bigincrease in clinical demand.

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    Table 4 Typical working week (excluding on-call)

    KeyNMC NHS medical consultantNCCS NHS consultant clinical scientistUMC University medical consultant

    Table 5 Origin of clinical laboratory work for consultants in clinical biochemistry

    % c l i n i c a l w o r k

    Referring clinical team NMC NCCS UMC

    General practitioners 44.0 36.4 32.9

    Physicians 26.0 31.5 34.6

    Surgeons 11.2 12.0 9.6

    Paediatricians .0 8.2 10.8

    Obstetricians .5 6.2 5.7

    Psychiatrists 2.5 2.3 3.6

    Others 2.8 3.4 2.8

    3.2.6 Secretarial supportA total of 72% of individual consultants currently have at least a share of a secretary.However, there is a sharp contrast between the 90% of medical consultants and the 55% ofnon-medical consultants that have secretarial support.

    % w o r k i n g w e e k

    Job function NMC NCCS UMC

    Direct patient care (inpatient and outpatient) 17.5 0 10.3

    Validation and reporting results 23.1 26.3 2.6

    Clinical liaison discussion of results 7.0 7.7 3.0

    Clinical liaison ward visits, etc. 4.8 3.4 1.6

    Providing scientific insight 4.8 7.3 7.6

    Quality (governance, audit, accreditation) 5.5 8.4 4.6

    Research and development 5.5 6.6 20.3

    Teaching /training of staff/students 4.3 4.5 7.4

    Continuing professional development 4.3 4.8 2.4

    Management within the department 11.4 17.9 10.5Management elsewhere in the Trust 6.8 6.6 4.8

    Work for regional, national and other bodies 3.5 4.5 14.2

    Other functions 1.5 2.0 10.7

    Average hours worked (excluding on-call) 47.3 46.7 48.7

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    4 STAFFING IN CLINICAL BIOCHEMISTRY

    4.1 Total staffing

    4.1.1 Medical staffingData from the questionnaire are summarised in Table 6. Overall, there has been fall of8.5%from 239.3 wte medical staff in 1995 to 219.0 wte in 2001. This fall is largelyaccounted for by a reduction in non-career grade medical staff plus the planned reduction inthe number of trainees. The number of unfilled posts at 31 March 2001 was higher than in1995 resulting in a reduction of 26.4 (11.5%) staff in post.

    4.1.2 Clinical scientist staffingData from the questionnaire are summarised in Table 6. Overall, there has been fall of8.0%from 622.4 wte clinical scientist staff in 1995 to 577.8 wte in 2001. This fall is totally

    accounted for by a 13% reduction in grade B clinical scientist staff. The number of unfilledposts at 31 March 2001 was higher than in 1995 resulting in a reduction of 66.5 (10.7%)staff in post.

    4.1.3 Biomedical scientist staffingSome 119 departments (49%) returned comparative figures for BMS staff. The results shownin Table 6 reveal a 1% increase in the establishment but a 1% reduction of staff in postbecause of the difficulties of recruiting and retaining BMS staff. This data supports two recentthorough studies on BMS staffing.4,5

    4.1.4 Other staffingTwo other grades of staff work in clinical biochemistry laboratories medical laboratory

    assistants (MLA) and administrative and clerical staff (A&C). No survey of comparativenumbers of these grades of staff was undertaken in this study.

    4.2 Consultant staffing

    4.2.1 Total consultant staffingAs Table 6 shows, there is an almost 1:1 ratio of medical to non-medical consultant staffworking in clinical biochemistry departments. Neither the total number nor the ratio haschanged significantly between 1995 and 2001.

    4.2.2 Medical consultant staffing

    Data from the RCPath identified the medical consultant establishment for clinicalbiochemistry as being 225 in 1995 and 226 at 30 September 2000. The 2000 establishmentfigure included 14 vacant and 19 part-time posts. A total of 202 consultants were identifiedas being in post in NHS departments at the commencement of this investigation; these wereeach sent a questionnaire (Table 2). Data from the departmental returns from thequestionnaire (Table 6) identified a total of 146.7 wte in 2001 equivalent to 201 wte for a100% return. This figure is 2.7 wte fewer than the corresponding figure for 1995. Theconclusion from this evidence is that the number of medical consultants in clinicalbiochemistry has remained static during the period 19952001.

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    Table 6 Staffing levels in clinical biochemistry: 1995 and 2001

    Staff grade S t a f f n u m b e r s ( w t e )

    31/03/1995 31/03/2001

    Medical consultant 144.9 (4.5) 140.3 (6.4)

    Non-career grade medical 15.4 (0.0) 7.2 (0.0)

    Trainee medical 69.2 (5.3) 55.6 (9.5)

    Total medical 229.5 (9.8) 203.1 (15.9)

    Consultant clinical scientist 153.9 (4.0) 156.8 (3.0)

    Grade B clinical scientist 415.5 (1.5) 350.2 (13.9)

    Grade A clinical scientist 50.5 (2.0) 46.4 (7.5)

    Total clinical scientist 619.9 (7.5) 553.4 (24.4)

    Total consultants 298.8 (8.5) 297.1 (9.4)

    Biomedical scientists (all grades)* 2095.3 (47.3) 2076.9 (98.2)

    KeyFigures not in brackets relate to occupied postsFigures in brackets are unfilled posts* Based on returns from 119 departments (49% of distribution)

    4.2.3 Clinical scientist staffingData from the ACB identified 230 consultant clinical scientists in clinical biochemistry in1995 and 217 in 2001. A total of 212 individuals were identified working in NHSdepartments and sent a questionnaire (Table 2). Data from the departmental returnsidentified 159.8 wte staff in post equivalent to 219 wte for a 100% return. The data inTable 6 reveals a 1% increase between 1995 and 2001. Taken together this data is alsoconsistent with essentially static staffing levels over the period of study.

    4.2.4 Consultant staffing and demographicsTable 7 expresses the number of medical consultants plus consultant clinical scientists inclinical biochemistry as a function of the nature of the hospital, the population served and theworkload of the departments. On average in 2001 there is one consultant in clinicalbiochemistry for every 174 000 people. Corresponding figures for other specialties inlaboratory medicine are: histopathology 50 000,6 haematology 100 000,7 and microbiology150 000.8 In all of the above specialties recent proposals have been made for large increases inthe number of consultants. 68 As may be anticipated there are fewer consultants in clinicalbiochemistry per 100 000 of the population in district general hospitals (DGHs) than in

    teaching hospitals.

    The average annual workload per consultant has risen dramatically between 1995 and 2001from 122 000 to 190 000 requests (+56%), and from 652 000 to 1 063 000 tests (+63%).Putting this data another way each consultant in 2001 is, on average, responsible for 630requests and 3500 test results on each normal working weekday. The total work perconsultant is somewhat greater in DGHs than in teaching hospitals the average number oftests per weekday per consultant being 3900 and 3200, respectively. An independent bodyhas already expressed concern about the rising workload in clinical biochemistry and theimpact that it will have on clinical risk and the ability of the consultant to maintain standardsof clinical interpretation and guidance.2

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    Table 7 Consultant staffing in relation to demographics and workload

    Department Average population

    served

    Consultant/

    department

    Population/

    consultant

    Teaching hospital 440 000 3.04 144 000

    District general hospital 276 000 1.32 209 000

    Childrens hospital 2 320 000 1.51 1 536 000

    Total 302 000 1.73 174 000

    Department Requests /department Requests/consultant1995 2001 1995 2001

    Teaching hospital 332 000 522 000 104 000 172 000

    District general hospital 169 000 263 000 137 000 199 000

    Childrens hospital 110 000 149 000 70 000 98 000

    Total 212 000 331 000 122 000 190 000

    Department Tests /department Tests/consultant1995 2001 1995 2001

    Teaching hospital 1 824 000 2 882 000 573 000 948 000

    District general hospital 917 000 1 546 000 745 000 1 171 000

    Childrens hospital 427 000 539 000 270 000 354 000

    Total 1 128 000 1 839 000 652 000 1 063 000

    4.3 Audit of minimum senior staffing model

    In 1996, the ACB and RCPath jointly published a model to calculate the minimum number ofsenior staff required in each clinical biochemistry laboratory.9 The definition of senior staffingused in this model was consultant level staff plus principal clinical scientists. After five yearsof operation the questionnaire provided an opportunity to audit the use and effectiveness ofthis model. The results of this audit are shown in Table 8. It is clear that just 52% oflaboratories have had cause to use the model. Where it has been used there is strongagreement that it is soundly based, straightforward to apply and that it produces valid results.However, in less than 30% of cases did Trust managers take any action based on the results.A lack of funding was the reason almost universally offered in free text for management

    refusing to acknowledge the results of the model. The reason most commonly offered for notusing the model was a lack of conviction that management would take any notice of theresults!

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    Table 8 Audit of minimum senior staffing model

    Criterion % responsesYes No

    Use of model 52

    Model is soundly based 77 23

    Model is straightforward to apply 88 12

    Model produces credible results 89 11

    Managers acted on the model results 25 75

    Department benefited from the model 29 71

    Use of model 48

    Department unaware of model 7 93

    Occasion did not arise to use model 64 36

    Model too complex to use 18 82Data not available for model 9 91

    Model seen as irrelevant 28 72

    Model seen as a threat 4 96

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    5 PRESSURES IN CLINICAL BIOCHEMISTRY

    5.1 Clinical governance pressures

    5.1.1 Laboratory accreditationThere is considerable pressure within the profession, from management and from users ofclinical biochemistry services to see objective evidence of quality standards. This evidence ismost conveniently demonstrated through CPA laboratory accreditation. Data from CPAannual reports on the status of laboratory accreditation in clinical biochemistry departmentsis shown in Table 9. Corresponding data from the questionnaire is shown in Table 10.

    Table 9 Clinical biochemistry: CPA laboratory accreditation status: 1995 and 2000

    Year Still to apply Unconditionalapproval

    Conditionalapproval

    Referredno status

    1995 133 105 22 3

    2000 31155 38 14

    Table 10 Laboratory accreditation status: 1995 and 2001: questionnaire

    Year Still to apply Unconditional

    approval

    Conditional

    approval

    Referred

    no status

    1995 53 89 28 3

    2001 6 109 38 5

    Some explanation is needed in the interpretation of the data in Tables 9 and 10. The datafrom CPA (Table 9) is restricted to single specialty clinical biochemistry departments.Although most of these will be NHS departments a small number will be in the private sector.This data does not include any multi-specialty laboratories. Although most of these willoperate outside the NHS, a few will be NHS departments that have returned questionnaires.On the other hand the returns from the questionnaire include less data for 2001 than for1995, perhaps reflecting the current state of transition of many departments. Comparison ofthe data in Tables 9 and 10 suggests that the departments that have no accreditation status(yet to apply or referred) are less likely to have completed and returned a questionnaire.

    Overall, three broad conclusions may be drawn from this data:

    a large number of clinical biochemistry departments gained CPA accreditation between

    1995 and 20002001

    a relatively small number of clinical biochemistry departments have yet to apply forCPA accreditation

    a small, but growing number of departments are finding it difficult to achieve and/ormaintain unconditional accreditation. For example, data from the survey reveals 15laboratories that had unconditional accreditation in 1995 but only conditionalaccreditation after re-inspection.

    Evidence that consultants are devoting increased time to achieving and/or maintaining CPAaccreditation is presented in Chapter 6.2 and also in the freehand comments summarised inAppendix 3.

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    5.1.2 Turnaround timesData from the questionnaire is summarised in Table 11. A total of 91% of departments haveexperienced demands to improve the turnaround time of results in the period between 1995and 2001. The vast majority of laboratories (84%) have managed to deliver improvedturnaround times despite the growing workload (Chapter 3). However, a significant minorityof laboratories (8%) are delivering a slower turnaround time for results in 2001 compared to1995.

    Table 11 Turnaround times (TAT) in clinical biochemistry: 1995 and 2001

    N u m b e r o f d e p a r t m e n t sCriterion Unchanged Increased Decreased

    Demand for faster TAT 15 147 0

    Delivery of faster TAT 13 134 13

    5.1.3 External quality assuranceThe strategic review of pathology services recommended that all laboratories must participatein external quality assurance (EQA).10 Data from the questionnaire is recorded in Table 12. Alarge number of departments (84%) increased their EQA participation between 1995 and2001. In 52% of cases an improvement in EQA performance has occurred, with no change inperformance in another 41%. However, 7% of departments have experienced deterioration inEQA performance. Although the general level of performance remains satisfactory, 53% ofdepartments have current concerns about the EQA performance for one or more analytes. Infreehand comments these concerns are largely attributable to individual poorly performingmethods on large commercial platforms, where the laboratory cannot influence performance.

    Table 12 External quality assessment in clinical biochemistry: 1995 and 2001

    N u m b e r o f d e p a r t m e n t s

    Criterion Unchanged Increased Decreased

    EQA participation 20 140 6

    EQA performance 69 86 11

    Yes No

    Current EQA concern 84 76

    5.1.4 BlundersA blunder is defined as an error made by the laboratory during the pre-analytical, analytical

    or post-analytical stages of laboratory operation. Publications in the scientific literatureindicate that the total blunder rate in clinical biochemistry is of the order of 0.3% withanalytical blunders much lower at 0.04%.11,12 Blunders are most likely to be experienced in thepre-analytical stage, during specimen collection and reception.13 Departments were asked tocomment on their comparative blunder rates for 1995 and 2001 and to distinguish betweenminor blunders (identified and corrected within the laboratory) and major blunders (incorrectdata issued by the laboratory). The data is displayed in Table 13.

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    Table 13 Assessment of laboratory blunders in clinical biochemistry

    % r e s p o n d e n t s

    Criterion Yes No % changeLaboratory records all blunders 90 10

    Distinguishes minor and major events 77 23

    Laboratory investigates all complaints 93 7

    Increase in minor events 19952001 88 12

    Increase in major events 19952001 78 22

    Increase in total events 19952000 87 13

    Estimate of change in total events +46%

    This data shows that the vast majority of departments now have a secure system for recording

    and investigating blunders. Several laboratories felt unable to offer an assessment of thechange in blunder rate because they were not recording data in 1995 and yet morerespondents commented that the increase may be more apparent than real because ofimprovements in recording. Therefore, the average increase in blunder rate of +46% is at bestan estimate, but it is interesting to note that is a similar increase to the total workload.Assuming that the published blunder rates apply,11,12 the data from the questionnaire indicatesthat in 2001 the average clinical biochemistry laboratory will make approximately threeblunders of any kind every day and approximately two analytical blunders each week.

    Two other estimates of changing blunder rate were obtained as part of this investigation.Firstly, one department which has been keeping detailed records of blunders for several yearswas able to demonstrate a gradual fall in the blunder rate over the period 19921999, only

    for it to double in the year 2000 (4199 events), during a period when three departmentsmerged in a single Trust [personal communication]. Secondly, data from UK NEQAS forclinical chemistry in Birmingham reveals that the non-analytical error rate (transcriptionerrors etc) doubled between 1995 and 2000 from 0.48% to 0.98% of returns to identicalEQA schemes [personal communication].

    5.1.5 Meeting clinical governance targetsAs part of the questionnaire consultants were asked to assess their confidence in theperformance of their laboratory and themselves in meeting clinical governance targetsexpected by professional colleagues and the general public for the years 1995 and 2001.Respondents were given a sliding scale from 1 (totally confident) to 9 (expecting a letter fromthe lawyer). The results, shown in Table 14, reveal that all three categories of consultant have

    lost confidence in all four targets areas. Overall, the average figures indicate a service incontrol but gradually deteriorating. However, Table 15 shows the same data analysed in adifferent manner. It records the number of total consultants recording scores in the range 79,which may be interpreted as showing a marked lack of confidence in meeting clinicalgovernance targets. It is interesting to note a sharp increase between 1995 and 2001 in twoareas. The pre-analytical area of activity is concerned with the correct reception and labellingof specimens and is the greatest source of laboratory blunders.13 The increase in concernamongst some consultants in the area of direct clinical care may be interpreted as acombination of increased pressure on the consultant coupled with increased patientawareness.

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    Table 14 Confidence of consultants in meeting clinical governance targets

    A v e r a g e s c o r e f r o m s c a l e r a n g e 1 9

    NMC NCCS UMCTarget area 1995 2001 1995 2001 1995 2001

    Pre-analytical 3.5 4.0 3.2 4.4 2.8 4.2

    Analytical 3.1 3.3 3.0 3.2 2.3 3.3

    Interpretation 3.1 3.5 3.3 3.8 2.8 3.4

    Direct clinical 2.8 3.6 2.2 3.0

    KeyNMC NHS medical consultantNCCS NHS consultant clinical scientistUMC University medical consultant

    Table 15 Consultants with concerns in meeting clinical governance targets

    Number of consultants scoring 79

    Target area 1995 2001

    Pre-analytical 7 23

    Analytical 5 8

    Interpretation 9 9

    Direct clinical care 1 13

    5.2 Laboratory pressures

    5.2.1 Workload and staffingChapter 2 revealed a rapidly rising workload, compounded still further by an increase in theproportion of GP requests and pressure to deliver more services, more quickly for more of the24-hour day. Chapter 3 revealed that consultant staffing levels have remained static over thisperiod of rapid expansion, that there are less biomedical scientists in post, and that thenumber of non-consultant medical and clinical scientist staff fell by ~10%. Departments wereasked to assess the adequacy of their total staffing to cope with the workload received in1995 and 2001. Furthermore, they were asked to comment on the ability to cope in 2005,assuming continued growth in workload at the same rate and no change in staffing.

    The results, shown in Table 16 reveal the most alarming set of data from this wholeinvestigation. Put simply, in 1995 82% of departments thought staffing was adequate orbetter for the workload, but by 2001 89% of departments were struggling to cope and, unlessthere is a change in staffing, 98% of departments in 2005 will either be struggling or unableto cope with 72% in the latter category.

    As a follow-up to this question, departments that had recorded that they were eitherstruggling to cope or unable to cope were asked to identify the staff grades required to correctthe problem. The results of this analysis are shown in Table 17. What is revealed is the needfor an increase in all grades of staff, with biomedical scientists and consultants at the top ofthe list.

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    Table 16 Adequacy of total staffing to cope with laboratory workload

    Number of departments (%)

    Assessment of staffing 1995 2001 2005Staffing satisfactory or better 21 (13) 1 (

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    Table 18 Clinical demand for clinical biochemistry services: 19952001

    Departments (%)

    Clinical user Increased Decreased % changeGeneral practitioners 97 3 9.2%

    Hospital consultants 99 1 11.8%

    Total clinical demand 94 6 13.5%

    5.2.4 National service frameworksA number of national service frameworks (NSFs) (known by different names in differentcountries in the UK) are in the process of being introduced to improve the standard of healthcare in a number of key areas of public health. From a clinical biochemistry perspective threeNSFs are likely to impact on service demand diabetes, coronary heart disease, and cancer. 1720 Departments were invited to comment on the likely impact of these three NSFs both on the

    laboratory in general and on consultant time. Results are shown in Table 19.

    Table 19 Predicted impact of NSFs on clinical demand

    NSF Laboratory services % change

    Unchanged Increased

    Diabetes mellitus 9 91 3.1%

    Coronary heart disease 8 92 2.8%

    Cancer 10 90 3.2%

    Consultant time % change

    Unchanged Increased

    Diabetes mellitus 25 75 1.8%

    Coronary heart disease 24 76 2.0%

    Cancer 32 68 1.5%

    Summarising the results it is clear that a very high percentage of consultants believe that theintroduction of these NSFs will each further increase the clinical biochemistry workload, by~3% in each case. The impact on consultant time would also be increased, especially indiabetes and coronary heart disease where medical consultants in clinical biochemistry runoutpatient clinics. This trend is likely to increase still further with the development ofconsultants in metabolic medicine (see Chapter 6).

    5.3 Consultant pressures

    5.3.1 Stress assessmentConsultants were invited to assess their work related stress in two areas of activity, both in1995 and 2001. A sliding scale was available ranging from 1 (unstressed) to 9 (about to havea nervous breakdown). Results are recorded in Table 20. It is clear that whilst there has beenan increase in both areas of activity for all three categories of consultant, the stress withinnormal working hours has risen dramatically between 1995 and 2001. This is even moremarked when the data is analysed to show the number of consultants recording a highlystressed score in the range 79 (Table 21).

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    The ten consultants currently experiencing severe stress with out of hours working are allsingle-handed and providing 24-hour, 7-day, 52-week cover. Of even more concern is the factthat 86 consultants (36% of the total response) are experiencing severe stress during thenormal working day.

    Table 20 Assessment of stress being experienced by consultants

    Average score from scale range 19

    NMC NCCS UMC

    Area of activity 1995 2001 1995 2001 1995 2001

    Working day 3.8 5.6 4.0 5.8 3.9 5.4

    Out of hours 2.7 3.2 2.9 3.6 2.1 2.5

    KeyNMC NHS medical consultant

    NCCS NHS consultant clinical scientistUMC University medical consultant

    Table 21 Consultants experiencing high stress levels

    Number of consultants scoring 79

    Area of activity 1995 2001

    Working day 10 86

    Out of hours 3 10

    The scale used for assessing stress was deliberately the same as that used to assess confidence

    in meeting clinical governance targets (Section 5.1.5). Comparison of the data in Tables 14and 20 reveals that the working day stress rating is considerably higher than can be accountedfor by concerns with meeting clinical governance targets. As Chapter 6 and Appendix 3 willreveal, the main source of stress is increase in management functions for consultants, whichare compounding the increased clinical workload described earlier (Section 4.2).

    5.3.2 Absence coverConsultants were asked how cover is provided for their absence from work during holidaysor through sickness. Results are shown in Table 22. A total of 113 single-handed consultantswere identified who obtain absence cover from a combination of non-consultants (mainlygrade B clinical scientists), consultants from other departments or locum consultants. Fivesingle-handed consultants volunteered the information that since it is virtually impossible to

    get locum cover they take a mobile phone with them wherever they go, so that they areliterally on-call 365 days a year.

    Table 22 Absence cover for consultants in clinical biochemistry

    Absence cover Number of consultants

    Consultant from same department 141

    Non-consultant from same department 94

    Consultant from another department 44

    Locum consultant 21

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    5.3.3 Research and development and scientific publicationsAs pressure on consultants mounts, something has got to give. For many consultants inclinical biochemistry that something is research and development. Table 4 reveals that NHSemployed consultants currently only manage to spend 6% of their time on this activity and asChapter 6 will reveal this percentage has dropped over the past five years for a large numberof consultants. Detailed examination of the data from the questionnaire reveals that 46consultants (20%) now do no research and development, even though this activity will bepart of their job description. Absence of research and development is most commonly seen insingle-handed consultants working in DGHs.

    Comparing the number of peer-reviewed scientific publications in 1995 and 2001 reveals theimpact of the reduction in research and development by NHS consultants. This data is shownin Table 23. In effect the strong position that the UK has held in the science of clinicalbiochemistry is being eroded.

    Table 23 Scientific publications in clinical biochemistry

    5.3.4 Planned age of retirementThe average age and planned age of retirement of consultants is recorded in Table 24. It isclear that on average NHS consultant clinical scientists are older than NHS medical

    consultants, although both groups have been employed for the same time and both intend toretire at a similar age. University medical consultants are on average older than their NHScounterparts, have been in post longer and intend to retire one year later. The clear intentionof NHS consultants to retire 2.5 years earlier than the normal retirement age is anotherindicator of the pressure under which they are working and has implications for workforceplanning.

    Table 24 Age profile and retirement plans for consultants

    KeyNMC NHS medical consu ltantNCCS NHS consultant clinical scientistUMC University medical consultant

    Consultant category Total number of publications % change

    1995 2001

    NHS medical consultants 165 119 28

    NHS consultant clinical scientists 183 158 14

    University medical consultants 84 105 +25

    Consultant category

    Parameter NMC NCCS UMC

    Mean age (years) 46.5 51.7 52.6

    Male (%) 78 75 88

    Years as a consultant (years) 10.5 10.1 19.3

    Mean age of planned retirement (years) 62.5 62.7 63.6

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    5.3.5 Workforce planning

    5.3.5.1 The NHSE workforce national advisory board determines workforce planning for NHSmedical consultants in clinical biochemistry in England and Wales after receiving advice fromthe medical workforce unit of the RCPath. Through this mechanism, the number of traineeposts is agreed and National Training Numbers (NTNs) allocated accordingly. The intentionis to have the same number of specialist registrars gaining their CCST in any one year, asthere are consultant vacancies. The anticipated expansion in NHS medical consultant posts inthe second half of the 1990s did not occur, leading to a reduction in NTNs in recent years (asevidenced in Table 6) and the number of trainees is now broadly in balance with theanticipated consultant vacancy rate. Full details of this workforce plan are available from theRCPath. However, any expansion to the existing number of consultants will require aminimum of five years to achieve, following agreement to fund the increase in NTNs.

    5.3.5.2 Workforce planning for NHS consultant clinical scientists in clinical biochemistry is more

    complex for two reasons. Firstly, only a proportion of trainees will become consultants, manywho complete training and obtain MRCPath will remain as high grade B (principal grade)clinical scientists. Secondly, although grade A training posts are supernumerary and centrallyfunded there is no equivalent to the NHSE workforce national advisory board and posts areallocated at regional workforce development confederations in a process that involves severalscientific specialties competing for a limited number of training posts. The ACB workforceadvisory committee has drawn up a detailed annual schedule of the number of grade Aclinical scientists required to match the number of consultant and principal grade retirements,assuming an eight year interval before entry and eligibility for a post (i.e. period to obtainMRCPath). Full details of this plan are available from the ACB, but there is a clear shortfallin recruiting trainees. For example, in the period 20062008 some 89 clinical scientists areexpected to retire and yet only 44 grade A clinical scientists were appointed between 1998

    and 2000. As Table 24 suggests, the number of clinical scientist retirements reaches a sharppeak in 20092012 (total 147) and there requires to be a dramatic increase in trainees just tomaintain the current number of posts. Paradoxically, it would be easy to achieve rapidexpansion of consultant clinical scientist posts from the pool of trained (MRCPath) principalgrade staff but this would simultaneously reduce the numbers of these staff and furtherincrease the pressure on the recruitment of grade A clinical scientists.

    5.3.6 Consultant staffing assessmentTable 17 records the views of 161 departments of the profession that an additional 85consultants are required in 2001. This equates to a total of 128 consultants for the wholeprofession an increase of 31%. Table 17 also indicates that the profession will require anadditional 28 consultants (7%) between 2001 and 2005.

    The questionnaire also asked existing consultants to compare the need for additional NHSmedical consultant and NHS consultant clinical scientist staffing for the years 1995 and 2001.The assessment was performed using the sliding scale, with scores ranging from 1 (no need) to9 (absolutely essential). The results of this analysis are shown in Table 25 and they reveal avery similar assessment of consultant need by both consultant categories.

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    Table 25 Assessment of the need for additional consultant staff

    Average score from scale range 19

    NMC NCCSExisting consultant grade 1995 2001 1995 2001

    NHS medical consultant 3.0 5.0 3.5 5.1

    NHS consultant clinical scientist 2.7 4.3 3.5 4.6

    All consultants 2.9 4.5 3.5

    KeyNMC NHS medical consultantNCCS NHS consultant clinical scientist

    More detailed analysis of the returns to this question enabled an average assessment to beobtained for all the consultant returns from each department. An average score in the range79 was equated with the clear need for an additional consultant, whilst an increase of atleast 3 scale points between 1995 and 2001 to a score of 5 or 6 was equated with 0.5 wte ofan additional consultant. Table 26 was constructed from this analysis. It summarises theassessment of the profession for additional consultant staffing in the three categories shown.A total of 86 consultants were identified as being required, which endorses the figure of 85that arose from the analysis described in Table 17. Nineteen departments indicated the clearneed for additional consultant staffing but gave equal scoring to a medical consultant orclinical scientist most actually commented that they had no strong preference. By adopting apolicy of balancing medical consultant and clinical scientist numbers in any one departmentthe 19 could be subdivided into 12 medical consultants and 7 clinical scientists. Thus, insummary, this investigation has identified the need for an additional 86 consultants 39

    medical and 47 clinical scientists.Table 26 Assessment of additional consultant requirement by department in 2001

    Medical Clinical scientist Either Total

    27 40 19 86

    The figure of 86 consultants is based on returns from 162 of the 242 NHS clinicalbiochemistry departments in the UK. Adjusting the number of consultants for this 67% returnrate yields a total requirement for an additional 129 consultants 59 medical and 70 clinicalscientists. A figure of 129 additional consultants represents a 31% increase from currentlevels. The increase would provide an additional consultant for 53% of NHS clinical

    biochemistry departments (assuming that no department would get more than one additionalconsultant).

    This assessment is based on NHS functions. It is recognised, however, that teaching hospitalsmay have good reasons for appointing university consultants with some NHS duties, ratherthan full time NHS consultants.

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    6 CHANGING PRACTICE IN CLINICAL BIOCHEMISTRY

    6.1 Introduction

    From the outset, the Task Force was aware that this investigation was being carried out atime of great change in NHS clinical biochemistry. Therefore, evidence of this change wassought as part of the investigation so that it could be considered in devising the action planfor the profession (Chapter 7).

    6.2 Changing laboratory practice

    6.2.1 Pre-analytical and analytical functionsTechnological development in clinical biochemistry has offered a range of developments in

    pre-analytical and analytical laboratory function, which could help to offset the large increasein workload. Respondents to the questionnaire were asked to indicate which of these they hadadopted. For each change introduced they were also asked to comment on its desirability. Thesame questions were also applied to two possible changes in the utilisation of staff working inthese areas. The results of this analysis are shown in Table 27.

    Table 27 Developments in pre-analytical and analytical function

    Function Number of departments

    Introduced Desirable %

    Computerised ward requesting 19 18 95

    Optical scanning of request forms 12 9 75

    Increased automation/robotics 51 40 78

    Common analytical platforms 63 45 71

    Primary sample handling 63 53 84

    Reduction in internal QC 22 10 45

    Increase in POCT hospital 53 31 58

    Increase in POCT community 23 12 52

    Extended working day 52 31 60

    Overtime payments for staff 29 11 38

    Other 10 8 80

    The lukewarm response to the introduction of more point of care testing (POCT) reflected theconsiderable extra work for laboratories in servicing and quality controlling POCT systemsrather than any fundamental objection to POCT. A number of respondents commented thatalthough they thought an extended working day to be desirable in principle it had beenintroduced without additional staff resource and had so increased pressure within thedepartment. In a similar vein some respondents were satisfied that their staff were being paidfor overtime but they would prefer to have sufficient staff to make overtime unnecessary.Finally, the most common other function introduced was a pneumatic tube sample deliverysystem.

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    6.2.2 Post-analytical practicesThe large increase in workload described in Chapter 3 has encouraged departments to giveconsideration to changes in practice in managing the interpretation and reporting of results.Respondents were asked to indicate which practices they had introduced and comment ontheir desirability. The results are shown in Table 28.

    Table 28 Changes in practice in post-analytical function

    It is clear that with the exception of electronic reports and the issue of guidelines to assistwith interpretation there is no great enthusiasm for these measures, which are seen asnecessary to help cope with the post-analytical dimension of the increased workload. Themost common practice included in the other category was the ability to report from home

    using a remote terminal.

    6.3 Changing consultant practice

    6.3.1 Multi-site workingFor many years, the normal structure for NHS clinical biochemistry departments hascomprised one department as an integral part of each NHS Trust hospital. More recently,however, cooperation and merger between Trusts has commenced in order to provide acomprehensive range of services across a larger population base. This development is likely tobe consolidated with the creation of ~30 new strategic health authorities in England.21 As aresult, cooperation and merger is also occurring within clinical biochemistry departments.Respondents to the questionnaire were asked to comment on the number of sites in whichthey work as a consultant. The results are shown in Table 29. Although one-site workingremains the largest group, multi-site departments are likely to increase during the next fewyears. Several consultants included travel between sites in the other category for theallocation of time in their normal working week (Table 4).

    Table 29 NHS departments of clinical biochemistry

    Number of sites per department 1 2 3 4

    Departments 193 44 10 5

    Number of departments

    Function Introduced Desirable %

    Reporting staff on site longer 38 17 45

    Reduced advice out of hours 8 1 12

    Restrictions on obtaining advice 2 0 0

    Wider limits for telephoning results 32 8 25

    Increase in electronic reports 144 117 81Increase in exception reporting 99 36 36

    Reduction in comments on reports 43 6 14

    Issue of interpretative guidelines 81 73 90

    Other 27 17 63

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    6.3.2 Changing consultant functionsRespondents to the questionnaire were asked to comment on changes between 1995 and2001 in the amount of time that they spent on each of the functions included in their normalworking week (Table 4). The summary of this data for all consultants is recorded in Table 30.The right hand column is the overall change based on a scoring system of increased = +1,decreased = -1; unchanged = 0.

    Table 30 Changing consultant functions: 19952001

    In Table 31 the same information is broken down according to the category of consultant.Overall, it is clear that there has been an increase in far more functions than there has been adecrease. The single biggest increase is in time spent on quality issues such as laboratoryaccreditation, audit and meeting clinical governance standards. Thereafter, the increase inmanagement related functions is even greater than the increase in clinical functions, despitethe large rise in workload described in Chapter 3. Education related functions show a steadyrise. The big loser is research and development (Section 5.3.3). It is interesting to note that theonly other function to show a net decline is the face-to-face discussion with clinicians in visitsto wards etc presumably because of pressure of time. A comparison between consultantcategories shows the same general trends.

    6.3.3 Perceived need for additional consultant functionsHaving identified the changes in consultant functions over the last six years respondents werethen asked to suggest the functions from which their department would most benefit if anadditional consultant was appointed. Different responses were invited depending on whetherthe additional consultant was a medical consultant or a consultant clinical scientist. Results ofthis analysis are displayed in Table 32. The results clearly reveal that the top priorities for anadditional medical consultant lie in the clinical areas and especially in those requiringincreased patient contact. In contrast, the top priorities for an additional clinical scientist areseen to lie in strengthening the scientific functions of the department, including furtherimproving quality standards. Education and management functions are given a much lowerpriority for additional consultant functions.

    N u m b e r o f c o n s u l t a n t s

    Function Increased Decreased Unchanged Overall

    Direct patient care 56 20 102 +36

    Validation/ reporting 138 54 33 +85

    Clinical discussion 136 29 57 +107

    Clinical visits 50 68 98 -18Scientific insight 74 38 103 +36

    Quality 183 8 30 +175

    Research/development 34 112 48 -78

    Teaching/training 102 38 76 +64

    CPD 106 32 84 +74

    Management department 161 17 49 +144

    Management Trust 117 22 71 +95

    Outside Trust 87 41 81 +46

    Other 18 0 0 +18

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    Table 31 Changing consultant functions: 19952001

    Overall score

    Function NMC NCCS UMCDirect patient care +34 Zero +3

    Validation/ reporting +28 +59 0

    Clinical discussion +54 +52 +2

    Clinical visits +10 -27 +1

    Scientific insight +13 +20 +3

    Quality +62 +101 +12

    Research / development -12 -63 -5

    Teaching/training +35 +21 +6

    CPD +27 +38 +8

    Management department +51 +82 +9Management Trust +42 +42 +9

    Outside Trust +22 +13 +11

    Other +4 +12 +1

    Number of responses 86 123 14

    KeyNMC NHS medical consultantNCCS NHS consultant clinical scientistUMC University medical consultant

    Table 32 Additional consultant functions required

    Number of responses

    Function Medical Clinical scientist

    Direct patient care 179 7

    Validation/ reporting 141 180

    Clinical discussion 192 169

    Clinical visits 210 109

    Scientific insight 64 195

    Quality 147 198

    Research/development 130 201

    Teaching/training 145 145

    CPD 77 92

    Management department 72 107

    Management Trust 25 24

    Outside Trust 22 31

    Other 4 6

    Number of responses 239 239

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    6.3.4 Metabolic medicineMetabolic medicine is a developing area that has suffered from a lack of clear identity,resulting in an inconsistent and variable level of clinical support across the country. In orderto cope with the rising workload and improve professionalism in this area the specialisttraining authority recently gave recognition to metabolic medicine as a training specialty. Thisrecognition occurred after the formation of the Task Force and distribution of thequestionnaire. Trainees from both the RCPath and the Royal College of Physicians (RCP) willnow be able to obtain accreditation in metabolic medicine. Within the RCPath it will be themedical consultants in clinical biochemistry who seek this accreditation. Once accredited, it isanticipated that these consultants will have appreciably greater clinical roles, including directpatient care in one or more of the following areas: diabetes, metabolic bone disease, lipiddisorders, nutrition, adult inborn errors of metabolism. At this point in time it is not clearwhat proportion of specialist registrars in clinical biochemistry will seek accreditation inmetabolic medicine. However, this development is very much in line with the prioritiesidentified for an additional medical consultant (Section 6.3.3).

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    7 ACTION PLAN FOR CLINICAL BIOCHEMISTRY

    7.1 Priority areas for action

    It is clear from Chapters 36 that:

    workload in clinical biochemistry has increased considerably during the last six years,both in terms of quantity and complexity; all the indications are that this trend willcontinue

    staffing in clinical biochemistry has shown an overall slight fall during thecorresponding period. Consultants work long hours

    clinical biochemistry departments have introduced a range of measures, sometimesagainst their better judgement, to accommodate the increased demands on analyticaland post-analytical functions

    despite these measures, the increasing pressures are beginning to cause loss of qualityand threaten clinical governance. A majority of departments are now struggling to copeand unless urgent action is instituted most will be unable to cope within four years.

    Therefore, the action plan for clinical biochemistry must have as its priority both increasingthe number of staff working in clinical biochemistry departments, and also ensuring thatworkforce planning for the specialty acknowledges this need at the earliest possibleopportunity.

    The Task Force was established with a specific remit for consultant staff and so this will bethe main focus of the action plan. However, it would b