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Inquiry ProceduresFor a summary of the Inquiry Procedure please go to the opening statement of the Chairman at the Preliminary Hearing
Bristol
Royal Infirmary Inquiry Purpose This note sets out the Inquirys process for dealing with formal written comments on clinical case note review (CCNR) forms and applications for Second Review. Background The procedure for the CCNR exercise was outlined in "The Inquirys approach to the Assessment of Adequacy of Paediatric Cardiac Services." The exercise was a review of the case notes, as was emphasised by the Chairman on the 9th December (transcript day 91, page 126-129 copies attached), and was not an attempt to determine personal negligence, or otherwise, in the management of the particular case itself. This procedure document explained that the purpose of the CCNR exercise was to provide the Panel with a qualitative perspective on the overall pattern of care, and to highlight areas where services were adequate or less than adequate, according to the clinical notes; the exercise was not designed to reach specific conclusions about individual cases. Any individual, however, with an interest in a particular case was able to make a formal written comment on a review groups conclusions and, further if they disagreed with the review findings on a particular case, submit a reasoned explanation as to why the case should be reviewed again. The Panel would then consider the matter. Formal Written Comments on Clinical Case Note Review Forms Formal written comments on CCNR forms will be treated in the following way:
Second Review Process The Panel has made it clear that when second reviews take place they will be carried out in the same way as the first review. That is to say, the Expert Review Teams will only consider the clinical case notes. Specifically, they will not have sight of, nor be asked to take into account, any formal written comments or the reasons surrounding the request for a second review. Where possible the experts invited to sit on Second Review panels will be those who previously participated in the review exercise but not in respect of the case in question. The expert group, as in the first review, will have access to the clinical case notes and to other investigations that are available: angiograms, echocardiograms, X-Rays, ITU and Perfusion Charts. The report of a Second Review will be circulated for comment. Publication Only those CCNR Report Forms where the Inquiry has full consent will be published, along with formal written comments on those reports. January 2000 THE CONCLUSION OF PHASE ONE ORAL EVIDENCE The purpose of this note is to outline the processes and deadlines by which the final oral evidence and presentations in Phase One will be taken by the Inquiry.
Inquiry Solicitors 12.10.99 PRELIMINARY CRITICAL OVERVIEW OF EXISTING DATA SOURCES RELEVENT TO THE INQUIRYS REMIT Summary The following consultation paper provides an overview of the strengths, weaknesses and limitations of the key existing data sources which the Inquiry considers to be relevant to paediatric cardiac surgery at Bristol. Guided by the advice of experts, the Inquiry is conducting a major review which includes the commissioning of analysis and research, contacting those responsible for relevant data systems and taking written statements. The extensive work of the Inquirys analysis team has, to date, highlighted six existing data sources which are of major relevance at this stage relevant to the Inquirys terms of reference. Two of these, Hospital Episode Statistics and the UK Cardiac Surgical Register, should enable comparisons to be made between Bristol and other centres. Two new databases have been created by the Inquiry using existing material from Clinical Records and from Surgeons Logs. The six key data sources are: Hospital Episode Statistics (HES) this system collected information about activity in all NHS hospitals in England (a similar system existed in Wales). Including over 50 million data records collected over a 5-year period between 1991 and 1995. This is largely an administrative system, and the Inquiry is examining retrospectively what it can reveal about relative performance on paediatric cardiac surgery at different hospitals. UK Cardiac Surgical Register established in 1977 by the UK Society of Cardiothoracic Surgeons to provide information on the volume, type and distribution of cardiac surgery, including paediatric cardiac surgery, undertaken in the UK in order to aid future service planning and clinical audit. Today, it is primarily used to track the development of the specialty, to identify trends and track and benchmark mortality for different procedures. South West Congenital Heart Register a computer register providing a summary of essential information about patients kept by the consultant cardiologists at the BRI throughout the period of the Inquiry. United Bristol Healthcare NHS Trust Patient Administration System (PAS) used to track hospital activity. It is an administrative system containing demographic and clinically coded information about the vast majority of patients who received treatment at the United Bristol Healthcare NHS Trust (UBHT including Bristol Royal Infirmary and Bristol Childrens Hospital) since 1988. Clinical Records a selection of information about over 1800 children treated at UBHT, collected from GPs, surgeons, anaesthetists, nurses and pathologists including: name, date of birth, gender, hospital record numbers, diagnoses, operative procedures and outcomes with dates and surgeons names. This information has been collated into a new database. Surgeons Logs the Inquiry has created a database from notes made in the surgeons logs of Mr James Wisheart and Mr Janardan Dhasmana. The information was recorded in the logs for reference purposes, for personal audit of operations undertaken and for reporting and research purposes. The Inquiry is aware of nearly twenty additional data sources which may be potentially relevant to its remit, but its priority now is to take forward analysis of the six data sources outlined above. 8 July 99
PROCEDURE TO BE FOLLOWED IN MAKING AN APPLICATION FOR CROSS EXAMINATION
17 5 99 Introduction The BRI Inquiry Panel, as was announced by the Chairman, Professor Ian Kennedy, at the Inquirys Preliminary Hearing in October 1998, is setting up a single Expert Group to inform and support the Inquiry. Individuals who are members of the Expert Group will be the Inquirys experts rather than experts for any individual or organisation which has an interest in the Inquirys work. Only Counsel to the Inquiry will be able to call experts to give evidence to the Inquiry. A single Expert Group The aim of this approach to the use of expert evidence in a public inquiry is to move away from the model used in trials, where expert evidence is presented in an adversarial setting. As experts to the Inquiry, those invited will be asked to give their opinion in the wider public interest, (indeed it will be published), rather than in support of the case of one side or another. As Professor Kennedy has made clear, there are no sides; there is no case. The Inquiry is there to inquire. The Chairman is also mindful of the relative scarcity of expertise in a number of areas of interest to the Inquiry. Thus, he wishes to gain the greatest benefit for the Inquiry by harnessing that expertise within one Expert Group. How experts will assist the Inquiry Experts may be asked to assist the Inquiry in up to three ways, but involvement will be at the experts convenience and depend on availability by providing (i) written opinions which will be the norm; (ii) by attending oral hearings to give evidence in person, and/or to be in attendance when another witness is appearing; (iii) by providing information and background to Counsel and Solicitor to the Inquiry. The extent to which any one expert actually assists in all three ways will depend on the area of expertise, the role that area of expertise may play in the Inquiry, and an individuals availability. Although experts principle obligation will be to serve the Inquiry direct, we should be grateful if experts could make themselves available, at their convenience, to give occasional seminars to the two groups whose costs are being met at public expense. Other organisations with a direct interest in the Inquiry may also seek advice from individuals on the Expert Group. All such requests for access to the Expert Group will need to be made through the Inquiry Secretariat. The Inquiry recognises that membership of the Expert Group may involve a considerable commitment; to lighten the load on any one individual, a number of experts will be invited to serve in each area of expertise. The following notes explain in more detail what is entailed by involvement in the Expert Group. WRITTEN OPINION
ATTENDANCE AT ORAL HEARINGS
This may be either as a sole witness or as part of a discussion to which two or three experts who apparently hold differing views will be invited to contribute. In the latter case, each will give evidence at the same time moderated, as it were, by Counsel, thus permitting an open, panel-type discussion amongst the relevant experts, focused and facilitated by Counsel.
BACKGROUND INFORMATION TO COUNSEL AND SOLICITOR TO THE INQUIRY BACKGROUND SEMINARS TO GROUPS RECEIVING PUBLIC FUNDING TO ENABLE PARTICIPATION IN THE INQUIRY
BACKGROUND ADVICE TO OTHER ORGANISATIONS Experts may also be asked occasionally, via the Inquiry Secretariat, to provide advice or explanations to other organisations with a direct interest in the Inquiry. A protocol will also be established for these contacts. APPOINTMENT OF EXPERTS Appointment of experts to the Expert Group will be by invitation only. The Inquiry has sought (and will continue to seek) advice from experts as to those others whose expertise is well recognised, with a view to ensuring that the Expert Group:
The Chairman will always be happy to listen to any suggestions for additions to the Group where it is considered that this will strengthen the ability of the Expert Group to be of assistance to the Inquiry, and similarly to any offers of assistance from any individual who has expertise to offer. It is not a disqualification for any given individual to be, or to have been, involved in litigation concerning any child treated at the Bristol hospitals between 1984 and 1995, nor for that individual to have been involved in the hearings conducted by the General Medical Council (GMC) which related to the care at Bristol of patients suffering from congenital heart problems, but any expert so involved will be expected to disclose his or her involvement. No expert will be asked to volunteer any confidential information which s/he may have obtained in acting in litigation or in relation to the GMC hearing. Similarly, any expert who shares membership of any club or society to which (so far as s/he knows), a witness or potential witness belongs, will be expected to disclose that fact. The Expert Group will include experts in the following areas of expertise:
BRI INQUIRY SECRETARIAT March 1999
THE INQUIRY'S APPROACH TO MAKING USE OF RELEVANT DATA SOURCES 1. Introduction The Bristol Royal Infirmary Inquiry intends to make full and effective use of available sources of evidence to inform its task. This includes making best use of available sources of data on childrens heart surgery in Bristol and elsewhere, drawing on specialist statistical and scientific expertise as required. 2. Relevant sources of data which may form the basis of statistical analysis A range of sources of data on childrens heart surgery exists, at both national and local level. 2.1 At national level, there are two main sources of data . They are as follows:
2.2 At local level, the sources of information which could inform statistical analysis include:
This originated back to 1988 and, as well as being a system for tracking patients within the UBHT, it is the source of the UBHTs returns for Hospital Episode Statistics, the national source mentioned earlier. In addition the Inquiry intends o draw on information collected and collated by the UBHT clinicians themselves. These sources include:
3. Issues of data quality In seeking to make effective and appropriate use of statistical data sources, the Inquiry intends to take account of crucial issues such as coverage, quality, relevance, comparability, and interpretation. We also want to understand the strengths, weaknesses and limitations of each of these sources. To this end, and as a broad framework within which to work, the Inquiry intends to adopt as a phased approach to making best use of available data. 4. A phased approach to making use of available data sources 4.1 The first phase will be to commission a preliminary critical overview of the sources outlined above. The aim of this overview, which we intend to publish, is to address key questions about the coverage and quality of each source, how the data were collected and validated, and the potential comparability of data sources. This overview will provide a context for subsequent statistical analysis, and will help to ensure that any conclusions reached, if indeed they can be reached from the data, are sound and capable of standing up to scientific and public scrutiny. 4.2 The second phase will be an exploratory phase. Here we will look at what each data source national and local - reveals about performance at Bristol. This will be a considerable undertaking, and will include:
Where appropriate, we will cross-validate sources of data. 4.3 At the end of this phase, the Inquiry, with the assistance of expert advice, will be in a position to determine whether the evidence suggests that Bristol had consistently or sporadically divergent performance, and if so in which aspects of childrens heart surgery. We will then know which areas warrant further detailed study. But it must be emphasised that all that would be known at this stage is whether variations in performance existed. The data themselves would tell us nothing about what caused any variation. 4.4 The third phase will be a confirmatory phase. Here the main interest lies in establishing whether there are any inherent technical biases in the data, both with regard to Bristol and to other centres, concentrating on those areas which are shown in the exploratory phase to merit special attention, e.g. particularly strong or weak areas of practice where lessons may be learnt. 4.5 If any divergence in performance between Bristol and other centres were confirmed in Phase Three, a fourth explanatory phase will be taken forward. We will seek expert advice on possible explanations and will undertake further investigations, including, potentially, more detailed assessment of clinical notes. This may also involve the collection of new data. 5. Summary The Inquiry is determined to make full and appropriate use of relevant sources of statistical data to inform its task, but this must be done with an awareness of the limitations on the quality of the available sources of data. We aim to make public during the course of the year, a critical review of the sources of data and, subsequently, both analyses of Bristols performance and expert opinion on what conclusions may reasonably be drawn from the data. The Secretariat Bristol Royal Infirmary Inquiry March 1999 Statisti/strat FORMAL WRITTEN COMMENT PROTOCOL
The fact that no indication is given is, however, no guarantee that the author of the original formal written statement will not be called to give oral evidence.
CLARIFICATION
OF RE-EXAMINATION OF WITNESSES 18th March 1999 On Wednesday 17th March 1999, Mr Lissack QC invited me to clarify what the Inquiry expected in terms of re-examination of witnesses. I am happy to provide, below, the clarification which Mr Lissack QC sought. At the opening of the Inquiry last autumn I said that
I also emphasised that after a witness had given evidence, there would be an opportunity for a short submission to be made the following day on that witnesss behalf. I made plain that, save in exceptional circumstances, submissions will be expected to be committed to writing. That remains our expectation. All that I said at the opening of the Inquiry remains good. I hope that, in the opening statement and since we started taking oral evidence this week, I have made clear the general position, namely that anything that reasonably can be expressed in the formal written statement, or, if that is not possible, can be channelled through Counsel to the Inquiry, should be. Therefore, where a matter has arisen since a witness statement was submitted which, had it arisen beforehand, the witness would have dealt with in that statement, then the Inquiry expects that a short supplemental statement, dealing only with the new point, will. be submitted as soon as possible. Where the witness is to be called to give oral evidence, the supplemental statement should, if at all possible, be submitted before the witness gives oral evidence. In the rare circumstances when this is genuinely not possible, the representatives of the witness should indicate to Counsel to the Inquiry that a fresh point has arisen, and invite Counsel to the Inquiry to lead the relevant evidence from the witness orally. What we do not expect is that a witness will be questioned by Counsel to the Inquiry and the Panel and only then be asked to deal, for the first time, with a fresh point not previously raised in the witnesss evidence. For one thing, no-one would have been in a position to consider whether the fresh point should be accepted or could be rebutted or commented upon. Those who have already commented on the witness statement are generally entitled to expect that they have seen the essentials of the intended evidence. The Inquiry recognises that there may be exceptional circumstances demanding a departure from the procedure I have set out. If such circumstances were to arise, the Panel will require to be persuaded that it would be helpful for the fresh point to be raised orally at that stage. In particular, the Inquiry will need to be persuaded that the point is not one that can be dealt with by a short written statement submitted on the following day, in accordance with the procedure I outlined at the opening of the Inquiry and to which I refer above. It is important for the Inquiry to progress efficiently and effectively. There is a risk that it might not do so if re-examination is to be free-ranging. There is much to do. The Inquiry is determined to adopt fair but also expeditious procedures. I appreciate that the Inquirys procedures differ from those of the courtroom; but we are not a court. I hope that that clarifies the situation. Ian Kennedy PROCEDURES FOR ASSESSMENT OF COSTS OF PARTICIPANTS AT PUBLIC EXPENSE 1. The Secretary of State accepted the recommendations of the Chairman that the reasonable and appropriate legal costs of the Bristol Heart Children Action Group and the Bristol Surgeons` Support Group be met from public funds on the terms as set out in letters dated 20 November 1998. The relevant statutory provisions with regard to these costs may be found in Section 84 (5) and (6) of the National Health Service Act 1977, as amended. 2. In the first instance costs will be assessed by the Costs Branch of Treasury Solicitor on the standard basis at an agreed hourly rate subject to a capping mechanism as to total hours worked. Where agreement can be reached those costs will be paid through the Treasury Solicitor. So far as the format of bills of costs is concerned these should be in the form of fully drawn bills along the lines of an inter partes bill of costs or as agreed with the Costs Branch. Counsels fees should be in the usual fee note form with clear indications of time spent. Counsel should be aware that they will be asked to provide details of the work undertaken and how it was generated. Bills should be presented on a monthly basis for consideration. All bills and fee notes will be subject to an audit procedure carried by the Costs Branch and/or the Internal Audit Service of the Treasury Solicitors Department. This may involve periodic visits to Solicitors offices. 3. General disbursements above £200.00 are liable to be disallowed unless they have received prior approval from the Solicitor to the Inquiry. 4.
The Inquiry reserves the right to disallow any costs for good reason:
examples of the circumstances in which costs may be disallowed are set
out in Paragraph 61 of the Report of the Royal Commission on Tribunals
of Inquiry (1966 Cmnd 3121). 5.
In the event of a bill not being agreed, in full or in part, payment will
be made on account of costs pending resolution at the end of the Inquiry,
possibly by means of taxation. 6. All claims for costs should be sent to Mr D Houghton, Head of Costs, Treasury Solicitors Office at Queen Annes Chambers, 28 Broadway, London SW1H 9JS. Tel: 0171 210 3192. Fax: 0171 210 3141. Inquiry procedure on the disclosure of potential criticism In his Opening Statement the Chairman announced that those who became the subject of potential criticism would be informed in writing and given 21 days to respond, subject to a prior undertaking as to confidentiality. Consequently, the Inquiry is proceeding as follows: · The Panel is currently considering those who may be subject to formal criticism on matters of material importance related to the subject matter of the Inquiry. · The Solicitor to the Inquiry is contacting all legal representatives and relevant witnesses requesting an undertaking as to confidentiality, in the event that it is necessary. · Subsequently in appropriate cases, on receipt of these undertakings, a letter will be sent briefly setting out the potential criticisms and identifying the evidence on which they are based. · The Solicitor must receive any response at the Bristol Office (details below) within 21 days; only in exceptional circumstances will this time be extended. Any application for extension must be made in writing, with reasons, before the end of the original period. · The Panel will consider the responses, taking them into account in the final formulation of the Report. November 2000 Bristol Royal Infirmary Inquiry 2/10 Temple Way Bristol BS2 OBY Tel: 0117 938 8735 Fax: 0117 938 8790 E-mail pwhiteh@bri-inq.org.uk PFO Whitehurst Solicitor to the Inquiry
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