Annex A > Chapter 18 - Medical and Clinical Audit > Audit at district and unit level > The approach of the District to audit after April 1991
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The approach of the District to audit after April 1991
212 The role and responsibility of the District for audit altered after trust status was conferred on the UBHT and the purchaser-provider split began in 1991. DHAs no longer directly managed hospital units and so their role, necessarily, had to change. Circular HC(91)2, [254] issued in January 1991, required DHAs to ensure a system of medical audit was in place by 1 April 1991.
213 Once the trusts were established, the districts' involvement in audit was through the mechanism of service agreement contracts between DHAs and trusts, and was therefore indirect. These agreements set out audit requirements, and provided that audit information was to be reported to a representative of the purchaser, often the Director of Public Health Medicine. [255]
214 Each trust put its own arrangements for audit in place. [256] Thus, the DAC evolved into the Medical Audit Committee (MAC) of the UBHT, [257] and no further audit committee was set up within the District in 1991.
215 The B&DHA's approach to audit through the `contracting' mechanism was formally agreed on the advice of its Director of Public Health, the lead officer for that area of work. [258] Dr Kieran Morgan, Director of Public Health at Avon Health Authority (Avon HA), stated: `Immediately after the formal establishment of Bristol and District Health Authority, [259] it began developing approaches to improving clinical quality.' [260]
216 From 1992 to 1995 the B&DHA's approach was to have a quality specification indicating the District's approach to quality which was common to all services, and a separate specification as to the service to be provided for each speciality. The latter specified if there were any additional monitoring requirements for the given year. [261]
217 The B&DHA's specification regarding quality was linked to outcomes in the form of enhanced health, but the guidelines for contracting continued: `We can also recognise that some measures which on the surface relate to process, rather than outcome, can themselves influence outcome. User involvement is an example of this.' [262]
218 The B&DHA did not have the capacity to monitor all aspects of service quality itself and therefore relied on each trust to report on selected aspects of service delivery according to a quality monitoring schedule which formed part of the service agreement each year. [263]
219 A Medical Audit and Clinical Standards and Outcome Measurement (MACSOM) Working Group was established by the B&DHA in 1993, under the chairmanship of Dr R Kammerling, a public health physician. According to Dr Baker: `The Committee sought to develop formal relationships with Medical Directors and Chairs of Trusts' Audit Committees for the contracting and funding of audit.' [264]
220 The aim was to agree not only firm contracting arrangements and sound audit processes, but also a limited number of areas for audit which would be recognised as of mutual concern and the findings of which would be supplied to the purchaser. Both process and outcome indicators of clinical quality were regarded by the District as relevant, but Dr Baker stated: `Dr Morgan advised that UBHT were adamant that they did not wish to generate and stick to clinical process standards and would wish to concentrate on outcome measures only.' [265]
221 In March 1995 Dr R Kammerling wrote a strategy for the Avon HA [266] on the further development of clinical audit. It contained a framework for assessing the development of clinical audit and was accompanied by Schedules of Agreed Audit Topics, agreed with the trusts. At that time, the Schedule agreed with the UBHT did not require an audit of paediatric cardiac services. [267]
The control of audit through the `contracting' process
222 The minutes of a meeting of the B&WDHA on 16 July 1990 record that: `Mr Dean Hart confirmed the Hospital Medical Committee's advice that only medically qualified personnel could negotiate, agree and implement contracts.' [268] Clinical directors, rather than general managers, were thus involved in the negotiation of contracts between the Trust and purchasing District.
223 1991-1992 was the first year in which `contracts' or service agreements between purchasers and providers came into use nationally. The first contract between the newly formed UBHT and the District contained the provision that:
`The Providers will have Quality Assurance systems which include elements of quality control, identification of service deficiencies, and mechanisms for correcting and reviewing problems.' [269]
224 The contract also included performance monitoring requirements [270] and provisions relating to audit within the individual contract for each specialty. The contract for cardiac surgical services had separate sections on medical audit, nursing audit and paramedical/support services audit.
`... include audit of outcome, the medical process and the management process ... the Cardiac Surgery Unit will set up an audit group to meet regularly and to provide the Bristol & Weston Health Authority with sufficient information for it to ensure that adequate audit is taking place.' [271]
226 In particular, the audit of outcomes was to include measures of 30-day mortality, one-year mortality and one-year symptomatic state. Ms Evans, the Contracts Manager of B&DHA from 1991-1995, expressed the view that those standards had most probably been discussed and agreed with the clinicians although she thought they were regarded as aspirational rather than actual standards to be attained. [272]
227 Before committing the Directorate to the service agreement, Mr Wisheart (as the surgeon who took the leading role on the Working Party which developed the service specification) wrote to Dr Roylance. His letter, of 13 March 1991, contains the following:
`I have been asked to sign this document as the basis for the contract for provision of Cardiac Surgery Services for the year beginning 1st April 1991. As I participated in the discussion which led to the production of this document I am of course in agreement with what it is aiming to do. Lest my signature at the end of this document should be construed as my agreement to the contract for which I am responsible and accountable I must state the following reservations;
`1. This service agreement contains no indication of the volume of work to be undertaken or agreed cost and payments ...
`3. We have agreed that the monitoring and reporting activities reported in Paragraph 18 to 21 should be provided. No resource or provision has been made to do this which may make it difficult or impossible to collect and report all of this data for the coming year.
`4. Specific reservations ... Paragraphs 15, 16 and 17 - the audit achievement [sic] are being established but may not necessarily operate fully from 1st April 1991.' [273]
228 Mr Wisheart gave his view of the concluded contract:
`The early service agreements set out that quality measures, we will say of the management type, and a whole range of them, would be measured, and they were monitored and shared I think on a quarterly basis ... Secondly, there was a requirement that audit, that is, medical clinical audit, would be carried out ... I think initially the agreement was that they would be assured that it had been carried out, because that was generally the framework within which audit was carried out by clinicians and it was reported to the managers or the Board and they were assured that it had been carried out, rather than providing them with all the detailed information ... The third element is the element of the additional agreed topics of audit. That agreement included, of course, the exchange of information because it was actually a collaborative exercise, in essence. So there was full and free exchange of information within that agreed topic.' [274]
229 The view of the District in relation to the same contract was given by Dr Baker:
`... Initially, the first specification for contract in 1991/92 did carry a requirement for various aspects of the product of audit, including 30-day post-operative mortality. It was unspecified, but I think it was linked to other matters which suggested that we were thinking about adult activity. Then I think subsequently both in terms of our own reasoning and with advice that we received from others, we realised we had been over-ambitious in what we were asking for in that first contract. Subsequently, those aspects of quality were rephrased in various ways and moved in general terms more to a requirement for audit to be taking place rather than having the expectation that we could be provided with precise information on different aspects.' [275]
230 Dr Baker went on to say that subsequent contracts contained more general requirements that aimed to ensure that a suitable process of audit took place, rather than requiring specific indicators to be provided. [276]
231 The first contract provided that figures relating to outcomes in cardiac surgery should be provided to the DHA. They were to be provided directly to the purchaser, and were not passed through, nor did copies have to be sent to, the MAC. Dr Thomas explained that this was:
`... because contracts were perceived as following a different route from audit and a sort of schism between the two was quite clear. In the Trust's mind and in I think the Audit Committee's mind as well, the contract negotiations would proceed and would only involve the Audit Committee if the Trust asked the Audit Committee to be a conduit for the passage of information from the directorate to the purchaser'. [277]
`At that time [1991] there was a clear undertaking being given by cardiac surgery to the purchaser that they would provide, to the purchaser direct, figures of mortality. As far as the Audit Committee were concerned, those figures were passed and we were not given any information that they were not passed. They did not go through the Audit Committee, much to our regret, because we believed that that should be a function of an Audit Committee. We were defeated on this matter by both the purchaser, by the directorate, by the management and so on and so forth.' [278]
232 A quality monitoring schedule having been introduced as part of the service agreement for each year, the 1992/93 B&DHA service agreement contained a `Quality of Service' Schedule. A statement of `Key quality objectives' was set out. Rights conferred by the `Patient's Charter' were noted and it was stated that providers were expected to meet patients' rights. Monitoring arrangements were set out. The obligations in the agreement concerning `professional audit' were as follows:
`All Provider Units are required to develop medical/clinical audit programmes whose broad aims are to clarify and improve standards of patient care. These programmes should link with the Provider's overall approach to quality. Bristol & District Health Authority recognises that general features of professional audit will mean that:
- `Some audit activities will be highly confidential and will be confined to a small group of people. Others will operate under the general levels of confidentiality required by the NHS.
- `Some audit activities are best conducted on a multi-disciplinary basis.'
233 There then followed three specific topics for the provider units: hospital-acquired infections; unplanned re-admissions to hospital within four weeks; and pressure sores. [279] A report on audit programmes for medical nursing and Professions Allied to Medicine (PAMs) was required by the end of the year. [280] The agreement also contained a provision to hold a meeting during 1992/93 to review clinical audit.
234 The 1993/94 agreement recognised that there had not been just one meeting during 1992/93 to review audit, but a series of such meetings:
`During 1992/93 a series of meetings were held with Clinical Directors and Executives in each Trust to discuss progress with Clinical Audit. Bristol & District Health Authority intend to build on this constructive dialogue to develop our approach to clinical quality.' [281]
235 The agreement went on to state, under the heading `Professional Audit, ' (in recognition of the transition from medical to clinical audit):
`Bristol & District Health Authority acknowledge that Clinical Audit is primarily an educational process and must remain under professional control to achieve this goal. The clinical aspects of care are, however, no longer regarded as solely the province of clinicians and the need to develop clinical quality monitoring must be recognised.
`To ensure that this process has a measurable impact on patient care, it must expand beyond the medical profession to integrate work already taking place within the nursing and the paramedical professions.' [282]
236 To ensure that audit was taking place, the agreement provided that clinical, nursing and paramedical audit reports were to be provided by trusts to the B&DHA in April 1994. [283]
237 This followed discussions which had taken place with trusts, as a result of which, Dr Morgan stated, the B&DHA had published its own set of principles in `Medical Audit, Clinical Standards and Outcome Measurement' [284] and agreed a programme [285] for monitoring clinical quality for 1993/94 onwards. He noted: `... At this time, the principle of [the] Health Authority being able to nominate certain priorities for audit was established for the first time alongside a requirement that each Trust provides a report on its full clinical audit programme on an annual basis.' [286]
238 In the 1994/95 contract, the section on clinical audit was far more detailed than that in previous years. It outlined the aims of audit and the role of the B&DHA, which included:
`(a) to assure itself that clinical audit is being undertaken
`(b) to facilitate the integration of audit into the routine monitoring process by encouraging audit on topics where it has a specific interest.' [287]
`B&DHA will not attempt to impose a model of audit or define the audit programme. It will, however, look for evidence of well supported audit activity of a high quality.' [288]
239 The annual audit report on the Trust was to be provided to the purchasers. [289]
240 As part of the 1994/95 agreement, the District agreed a Schedule for audit with the UBHT, which identified certain activities that were to be the subject of audit. Some of those activities related to adult cardiac services.
241 From the outset, the contracts with the B&DHA envisaged that clinical directors might seek the advice of the MAC if requested by purchasers to provide information about clinical activity. However, in practice, Dr Thomas told the Inquiry that he could not recall ever receiving requests for information from purchasers:
`... I am casting back in my memory to see whether I can recall any particular figures that came through the Audit Committee and the nearest example I can come to you with is that in, I think, early 1992, our general practitioner representative, Dr Whitfield, came to a meeting and said he felt that the Audit Committee should have a more proactive role.' [290]
242 Dr Black also stated that he could not recall any specific requests from the purchasers to audit any particular aspect of the UBHT's activity during his tenure as a member of the Committee. [291]
243 The contract mechanism thus provided for returns to be made to the B&DHA. The DHA Contracts Manager would receive the returns from the UBHT and either analyse them, or pass them on to colleagues, and then submit an overall comment to the Director in the DHA responsible for monitoring quality. [292]
244 The contractual regime created some difficulties for the provider trust. Ms Evans said that: `One of the issues was that different purchasers would want to make different quality requirements of the same Trust, and one can imagine that with a Trust like UBHT with 43 purchasers, that would have been difficult.' [293]
245 By 1994/95, she reported, this was a general concern across RHAs throughout the country. [294]
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Footnotes
[254] HAA 0164 0023; circular HC (91)2
[255] WIT 0108 0046 Dr Roylance
[258] WIT 0159 0038 Ms Evans
[259] In October 1991, in succession to the B&WDHA
[260] WIT 0307 0005 Dr Morgan
[261] WIT 0159 0027 Ms Evans. See, for example, the list of incorporated Schedules in the B&DHA's 1993/94 Service Agreement, WIT 0159 0047 Ms Evans
[263] WIT 0159 0027 Ms Evans
[264] WIT 0074 0038 Dr Baker
[265] WIT 0074 0038 Dr Baker
[266] The Avon Health Authority, recently formed
[267] WIT 0074 0039 Dr Baker. Arrangements for a multidisciplinary audit of paediatric cardiac services were subsequently made later in 1995, after the service had received adverse attention and publicity. Results for open and closed surgical procedures from May 1995-January 1996, undertaken by Mr Pawade, were received by Dr Baker, and agreed as a baseline of satisfactory activity
[268] UBHT 0249 0087; minutes of meeting of the B&WDHA 16 July 1990
[269] HAA 0011 0248; service agreement
[270] WIT 0159 0027 Ms Evans
[271] HAA 0010 0094; service agreement
[273] HAA 0011 0254 - 0255 ; letter from Mr Wisheart to Dr Roylance dated 13 March 1991
[274] T41 p.99-100 Mr Wisheart
[279] HAA 0156 0152; service agreement
[280] HAA 0156 0179; service agreement
[281] HAA 0156 0331; service agreement
[282] HAA 0156 0340; service agreement
[283] HAA 0156 0341; service agreement
[284] UBHT 0028 0155; `Medical Audit, Clinical Standards and Outcome Measurement'
[285] One topic was hospital mortality following operations for coronary artery bypass grafting
[286] WIT 0307 0005 - 0006 Dr Morgan
[287] HAA 0156 0429; service agreement
[288] HAA 0156 0430; service agreement
[289] HAA 0156 0430; service agreement. Evidence of the circulation of the UBHT's annual audit reports is to be found at paras 314-17, 364, 378 below onwards
[290] T62 p.82 Dr Thomas. Dr Michael Whitfield (Consultant Senior Lecturer in General Practice) produced a paper which suggested a role for the Audit Committee - UBHT 0026 0063
[291] WIT 0326 0004 Dr Black
[292] WIT 0159 0030 Ms Evans