Design Gisborne Cervical Screening Inquiry
[CSI Report]
[Media Releases]
[Proceedings]
[Progress Reports]
[Background]
[About the Inquiry]
[Getting Help]
[Other Reports]

 

Report of the Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne Region

5. Term of Reference Two

What are the factors that are likely to have led to the under-reporting?

5.1 Dr Bottrill was at a loss to explain why so many of the cervical smear tests read at Gisborne Laboratories had been under-reported. The only explanation he could offer was that his work performance had deteriorated after he had undergone heart surgery in July 1990.

5.2 Counsel for the women affected submitted that in answering Term of Reference Two the Committee should identify both direct and indirect factors that are likely to have led to under-reporting. However, Counsel for the Ministry of Health submitted that even if there were defects in the Programme’s delivery, those defects could not have led to the under-reporting. The Committee considers that the phrase " to identify the factors that are likely to have led to that under-reporting" has a meaning which goes beyond identifying the immediate cause of the under-reporting. Clearly the immediate cause of any under-reporting is someone misreading a smear test. By directing the Committee to identify the factors that are likely to have led to unacceptable under-reporting the Minister of Health is seeking an answer which may go some way to explain how the under-reporting came about. This will inform the Minister of the steps that need to be taken to ensure that unacceptable under-reporting is avoided in the future. Unless the Minister is made aware of all the factors without which damage could not have occurred the Minister will not be best placed to determine the remedial action required. For this reason the Committee considers that Term of Reference two requires it to look for all factors which directly or indirectly materially contributed to the under-reporting.

5.3 In the Committee’s view there are a number of factors that are likely to have led to the unacceptable level of under-reporting at Gisborne Laboratories. These factors fall into two groups: those that relate directly to the practices followed in Gisborne Laboratories when reading cervical cytology; and those that relate to the delivery of cytological services in New Zealand between the years 1990 to 1996. The second group of factors directly influenced how cervical cytology was carried out in Gisborne Laboratories during this time. Each group of factors is discussed in turn below.

Factors Relating To Practices Followed In Gisborne Laboratories

5.4 The factors relating to practices in Gisborne Laboratories that are likely to have led to under-reporting of cervical smear tests are:

(i) No specialised division of labour for reading cervical smear tests;

(ii) Inadequate internal quality control including no organised correlation of biopsy results with cytology results;

(iii) Inadequate systems and procedures;

(iv) No external quality control;

(v) No accreditation with an independent quality control authority;

(vi) Dr Bottrill’s inadequate participation in continuing medical education; and

(vii) No awareness that the laboratory’s practices put patients at risk.

Each of these factors, their impact on the laboratory’s performance and the likelihood of them leading to under-reporting is discussed below.

No Specialised Division Of Labour For Reading Cervical Smear Tests

5.5 In most laboratories cervical smear tests are screened by more than one person. The usual practice is for a specially trained cytotechnologist or cytoscreener to carry out the primary screening. This entails the careful microscopic examination of slides on which cellular material from the cervical smear is fixed. It can be a monotonous repetitive task as the examination of each slide follows a set pattern. Cytotechnologists and cytoscreeners are trained to look for unusual-looking cells on the slide as these indicate cellular abnormalities. Their task is to sort the abnormal from the normal smears. Once the abnormal smears are identified they are sent to the laboratory pathologist who also examines them and then categorises the type of cellular abnormality.

5.6 The importance of a specialised division of labour when reading cervical cytology has been well recognised for some time. The World Health Organisation issued a Bulletin in 1986 titled Control of Cancer of the Cervuix Uteri which stated:

"All smears should be processed and screened at a cytology laboratory in which the following procedures must be performed: staining, examination by a cytotechnologist, confirmation by a cytopathologist, communication of results to a clinician and follow-up of all cases of abnormal cytology. (emphasis added)

In the same passage the need for pathologists and other laboratory staff to maintain their competency in cervical cytology by reading a large volume of cervical smear tests and by avoiding working in isolation was also recognised:

"Cytology services should be centralised. A large volume of work contributes to the successful operation of a cytology laboratory because a specialized division of labour is possible and a large number of abnormal smears representing various pathologies will help to maintain the cytotechnologists’ skills. …Usually single unsupervised technicians should not be placed in isolated areas or health centres, since even well trained screeners will lose their skills if not exposed to a large number of positive specimens, teaching and supervision."

5.7 At Gisborne Laboratories there was no specialised division of labour when it came to reading cervical smear tests. The cervical cytology was read by one person, and this was usually Dr Bottrill. He was the only pathologist that Gisborne Laboratories permanently employed. Of the 22,976 smear tests sent to Douglass Hanly Moir Pathology in Sydney for re-reading, 20,860 had originally been read by Dr Bottrill. Gisborne Laboratories received approximately 4000-5000 cervical smear tests per annum.

5.8 Dr Bottrill carried out all the primary screening of the smear tests, even though he had no specialist training in cytoscreening. On the occasions when Dr Bottrill went on leave and a locum was employed the locum also carried out the entire task. On his return from leave Dr Bottrill did not check the smear tests which the locum had read. Occasionally, when the workload became too heavy, Dr Bottrill employed a locum to assist him. Once again the practice was for Dr Bottrill and the locum to work separately on an allotted group of slides. Dr Bottrill said that for the first week he would check the locum’s work by re-reading the smear tests and the reports; after that the locum was left to do his allotted work. Dr Bottrill used to rescreen 10% of the negative smear tests approximately once a week and when a locum was employed it seems that Dr Bottrill included the smear tests the locum read in the rescreening exercise. This was the limit of any sharing of the task of reading cervical smear tests.

5.9 The Committee heard no evidence to support primary screening of cervical smear tests being performed by a pathologist. Professor McGoogan, Dr Gabriel Medley and Dr Farnsworth are highly qualified and experienced cytopathologists. They each informed the Committee that they considered their skills were not suited to primary screening. In her evidence to the Committee Professor McGoogan said:

Dr Duggan Question Could I ask you for your own personal opinion on whether pathologists who have not been trained in the skills of primary screening should function as a primary screener?

A I have a very high regard for the skills of primary screeners, it is an exceptionally difficult skill to develop and maintain day in day out. It is not a skill which I have as an individual. I would have to undertake a similar training and concentrate my training in that area to achieve the same skills.

Q You, as an acknowledged expert in cytopathology, do not consider you should function as a primary screener .....

A Yes, I agree.

5.10 Other pathologists from whom the Committee heard evidence also did not think it advisable for a pathologist to perform primary screening. Dr Beer, a pathologist from Tauranga who gave evidence for the Association of Community Laboratories said he thought it dangerous for a pathologist to perform primary screening. Dr Teague, who gave evidence for the Royal College of Pathologists of Australasia said he did not consider himself competent to primary screen cervical smear tests and that he would not function as a primary screener. Dr Teague had organised a review of a small group of Dr Bottrill’s slides for an accident compensation claim against Dr Bottrill for medical misadventure due to the under-reporting of a patient’s cervical smear test. When Dr Teague learnt how Dr Bottrill practised cervical cytology he advised Dr Bottrill to stop reading smear tests and to send the laboratory’s cervical cytology elsewhere; Dr Bottrill did not follow Dr Teague’s advice.

5.11 Dr Bottrill said that he had not wanted to act as his own primary screener and that he had done so because: between the years 1990 and 1995 there was a shortage of cytotechnologists; Gisborne Laboratories did not have enough work to employ a full time screener; and given the shortage of cytotechnologists it was too difficult to find someone prepared to do this work part time in a rural area like Gisborne. An additional reason Dr Bottrill gave for carrying out the primary screening was that he wished to offer a full service to the Gisborne region and the alternative to him carrying out the primary screening was for Gisborne Laboratories to send cervical cytology elsewhere.

5.12 None of the reasons Dr Bottrill gave for the laboratory following this practice justifies it. There was no question of Dr Bottrill acting out of necessity. The cervical cytology of women from the Gisborne region could have been read at a laboratory in another region. All the cervical cytology from the Gisborne region is now read by laboratories in other regions. Since Medlab Hamilton purchased Gisborne Laboratories the cervical cytology that was read by Gisborne Laboratories is read in Hamilton. The Gisborne hospital laboratory has ceased reading cytology and sends any cytology it receives elsewhere. When Dr Bottrill was in practice, but on sick leave the cervical cytology Gisborne Laboratories received was read in a laboratory in Palmerston North. Between 1990 to 1996 there was no obstacle which prevented Gisborne Laboratories from sending cervical cytology elsewhere, if it had chosen to do so.

5.13 The practice of working alone that Dr Bottrill followed meant there was no opportunity for a second pair of eyes to view the cervical smear tests that he screened. Consequently, unless he arranged to seek a second opinion on a smear test, there was no likelihood of any error he made in reading a smear test being picked up. The Committee heard evidence from more than one pathologist on the risk of this practice to patients. The best evidence was given by Professor McGoogan:

CHAIR: Question I will start the scenario again, a small laboratory where you have one pathologist, no-one else employed full or part time, approximately 5000 smears per annum coming into the laboratory, the single pathologist doing all screening primary and then I don't know the format he used to screen abnormals, but have you got enough in front of you now to formulate an opinion? .....

A Yes. this is in my experience a very unusual situation. It is difficult in a situation where there is only one person for that individual to quality control themselves and while it is not impossible to maintain quality service under those circumstances it would be extremely difficult and would require exceptional measures to be put in place by the individual to ensure competence and a quality service.

Q Can you describe how it might be done, in other words, what those quality control measures might be?

A I can think of ways but what you are really asking me is if I want to set up a bad service how would I do it with the least risk to women.

Q You have said it could be done, so please outline the measures? .....

A There would have to be frequent and good interaction with pathologists in another laboratory whereby there was exchange of work between the two laboratories or at least in one direction from the single handed pathologist laboratory to the other laboratory for quality control, internal quality control, there would have to be well documented processes and data collected for that quality control. Biopsy smear correlation would be imperative in that situation so that the pathologist knew that patients that he recommended be referred for colposcopy had been appropriately referred, in other words, that the majority of these patients did indeed have disease and that the biopsy reflected the disease he suspected from his cervical smear report, and that he frequently participated in external quality assurance, he frequently attended meetings of cytologists with cytology topics pertaining to cervical screening, and that he ensured that his laboratory met all external accreditation procedures and processes that were available, and even then I think there are major risks involved.

5.14 The risk of error when one person reads all the cervical cytology was heightened by Dr Bottrill’s practice of cervical cytology as he did not regularly adopt any of the measures which Professor McGoogan outlined as essential to overcome the risks of a pathologist acting on his own:

He had no internal quality control of the type contemplated by Professor McGoogan;

He did not participate in any external quality control programme;

Gisborne Laboratories was not accredited with any independent accreditation authority;

It had no organised programme to correlate a patient’s abnormal cytology results with the later discovery of cancerous or pre-cancerous lesions by biopsy;

Dr Bottrill’s contact with other pathologists and his attempts at continuing education were insufficient to enable him to overcome the risks inherent in acting as a sole practitioner in cervical cytology;

When Dr Bottrill was asked about the measures which Professor McGoogan had outlined as necessary, if a pathologist were to practise cervical cytology on his own, he was unable to inform the Committee if his practices met these measures.

5.15 Dr Teague’s view of Dr Bottrill’s practice was similar to that of Professor McGoogan. He described the practice as suboptimal:

"Q Would you describe it as an acceptable practice?

A I think it would be sub-optimal the way it was done.

Q And why is that?

A Particularly for the reason that there was only one person doing essentially both the primary and secondary screening or rechecking. There was some evidence I believe that Dr Bottrill did rescreen 10% of slides and there are statistics which show in fact that if the same person rescreens a slide they may get a different answer so to that extent there will be some benefit from that, but I believe that it would not be the benefit that one would expect to from getting a different pair of eyes to look at it."

5.16 The Committee accepts the views that these witnesses have expressed about Dr Bottrill’s practice. It agrees with the view expressed by Professor McGoogan that a laboratory that employs one person to carry out this task is providing a bad service. It considers that the somewhat subjective nature of the task of reading cervical cytology makes it too risky for one person to carry out, as misread smears are less likely to be discovered. The Committee considers that the practice followed at Gisborne Laboratories of having one person read the cervical cytology is a factor that is likely to have led to the unacceptable level of under-reporting that occurred at the laboratory.

Inadequate Internal Quality Control

5.17 In his evidence Dr Bottrill expressed the view that quality control was something which played a greater role in large laboratories and he saw no need for it in a small laboratory like Gisborne Laboratories. The internal quality control that he employed consisted of him, approximately once a week, re-reading 10% of the smear tests that he had originally read as normal. He neither documented this exercise, nor did he compare the re-read results with the original results. He could not recall any occasion on which, when carrying out a random re-reading of slides, he had discovered a smear test which he had originally read as normal and which on rereading he found to be abnormal. Nor could he remember a time when, on re-reading a slide, he became concerned about his original report. Considering the number of under-reported smear tests that have now come to light it seems surprising that the 10% random re-screening he carried out did not reveal any of these errors. The Committee can only conclude that Dr Bottrill had "calibrated" his eyes to read smear tests with a very high specificity and that on any second view of a smear test he was only corroborating his original error.

5.18 Apart from the 10% random re-screening there was little else done in the way of internal quality control. In 1993 when Gisborne Laboratories had applied for TELARC accreditation, work began on a quality control manual; however, this work cannot have been taken very far, or if it was it cannot have been effective as Medlab Hamilton found it necessary to replace it with its own quality control manual when it assumed control of Gisborne Laboratories.

5.19 Gisborne Laboratories had no organised programme for correlating biopsy results with cytology results. Dr Bottrill’s evidence was that he did keep records of cytology/ histology correlation on the occasions when the histology was sent to him for diagnosis. However, he accepted that where the biopsy was performed at the local hospital he was unlikely to receive information about the histology result. There was no formal communication between Gisborne Laboratories and the local hospital which would have provided him with this information. If Dr Bottrill had been able to conduct an organised programme correlating histology with cytology this would have informed him of the accuracy of his reading. It may have brought to his attention his false positive rate and true positive rate which the Committee knows to have been too low. Had Dr Bottrill realised his false positive rate was extremely low that may have made him alive to the probability that he was "setting the bar too high" and consequently under-reporting too many smear tests. Had he realised his true positive rate was too low he would have known that he was failing to recognise abnormal smear tests and reporting them incorrectly as normal (false negatives). A programme of looking back at a woman’s previous negative smear tests when she was found to have a high-grade abnormality on histology to determine if those smear tests were false negatives should have alerted Dr Bottrill to his under-reporting. In the circumstances the Committee’s view is that at Gisborne Laboratories correlation of histology with cytology occurred sporadically and was not sufficient to produce the quality control benefits which come from an organised programme of histology cytology correlation.

5.20 In the Committee’s view the internal quality control followed at Gisborne Laboratories was inadequate. It did not meet the expectations of internal quality control that Professor McGoogan outlined in her evidence. Her expectations of internal quality control are consistent with those of International Accreditation New Zealand (IANZ), the national accreditation authority for quality assurance, laboratory testing and industrial design. The Committee heard evidence from Mr Graham Walker the former programme manager medical testing and radiology of IANZ on the parameters of internal quality control. In Mr Walker’s view Dr Bottrill’s internal quality control fell outside these parameters.

5.21 Mr Walker visited Gisborne Laboratories in 1993 when it had applied to the Testing Laboratory Registration Council (TELARC), which formerly carried out IANZ’s functions, for accreditation. The application did not proceed. During his visit Mr Walker noted the absence of documented laboratory procedures and recorded that this was something which Gisborne Laboratories would have to institute if it were to become accredited. An additional aspect of internal quality control that IANZ considered significant, and which was lacking at Gisborne Laboratories was the ability to have a smear test checked by a second person. In his brief of evidence to the Committee Mr Walker said:

"An important aspect of internal quality control is the ability to release apparently normal slides on the basis that a second person within the laboratory has re-screened a proportion of those slides and validated the test results. Gisborne Laboratories did not have such a second person. There was, therefore, no internal quality check, as well as there not being any opportunity for Dr Bottrill in the cytology/histology context to exchange ideas with another cytopathologist. In such a circumstance there is extreme pressure on the pathologist to get the test result right as there are no other means to intercept problems and carry out frequent and random checks on test results".

5.22 The Committee considers that the lack of adequate internal quality control at Gisborne Laboratories is a factor that is likely to have led to the unacceptable level of under-reporting that occurred at the laboratory. Had the practices at Gisborne Laboratories conformed with the internal quality control requirements outlined above it is likely that the level of under-reporting which occurred would have been detected sooner or perhaps avoided altogether.

Inadequate Systems And Procedures

5.23 Dr Bottrill’s views on quality control being more suited to big laboratories may have coloured his opinion on the usefulness to a small laboratory of organised systems and procedures in general. The laboratory systems he followed had shortcomings: he had no procedure in place to prevent a slide mix up, although there is no evidence this had ever happened; he did not as a matter of routine carry out "look back" exercises of a woman patient’s previous smear tests; he had no system to inform him as to whether or not he had read a woman patient’s previous smear tests, (this meant that unless he was told by the woman’s smear taker that he had read her previous smear tests he had no way of knowing whether or not there were previous smear tests to look back on); he did not regularly get information about his female patients from the National Cervical Screening Register.

5.24 The deficiencies in the systems and procedures at Gisborne Laboratories would not have promoted a competent performance in cervical cytology. The Committee considers that this is a factor which, if not of itself, then certainly combined with the other factors listed herein is likely to have led to the unacceptable level of under-reporting that occurred at the laboratory.

No External Quality Control

5.25 Gisborne Laboratories did not participate in any external quality assurance programme. Dr Bottrill did not appear to place a high value on quality control. In his evidence to the Committee he said:

Q Was it your view at the time that measures such as external quality assurance and quality control systems played no part in affecting your standard of smear reading?

A Yes

Q So you didn’t think they would help your accuracy, is that right?

A I think that is correct, yes

Dr Bottrill said that he liased with a series of pathologists who were employed at Gisborne Hospital. He said he visited the hospital four or five times a week around lunchtime to have a general discussion with the current hospital pathologist and to show him or her any slides of interest or difficulty. He said that he maintained good collegial relationships by doing this and he was also able to obtain second opinions on difficult or interesting slides. However, he accepted that there was not always a pathologist employed at the hospital, that there could be periods of up to one year when nobody was there and that at those times he was the only pathologist in Gisborne. The Committee considers that the informal interaction Dr Bottrill had with the pathologists at Gisborne Hospital was insufficient to remove or reduce the risk inherent in practising as he did. It comes nowhere near the type of interactions that are carried out for the purpose of external quality control.

5.26 Although the evidence shows that in 1991 there was no entirely satisfactory external quality assurance programme available, and it seems that was still so in 1993, the Royal College of Pathologists of Australasia offered a programme which was a step in the right direction and over the years this programme has developed and improved. The Committee’s view is that participation in an external quality assurance programme which is still in the early stages of development and which may not be entirely satisfactory has benefit nevertheless, as it should make a pathologist more alert to the possibility of error, and it should cause a pathologist to focus more on the need to adopt measures to reduce the risk of error occurring. The external quality assurance programme which the Royal College of Pathologists of Australasia offered involved a pathologist receiving slides from the College, reading them and reporting the results to a central collating agency and subsequently receiving reports which compared the reports of his or her slide reading with the consensus view of the other pathologists who participated in the programme. In this way a pathologist was able to learn whether or not his or her reading of slides was within the average range or above or below that range.

5.27 Participation in such a scheme may have alerted Dr Bottrill to the likelihood that he was failing to recognise some abnormal smears and consequently he was under-reporting the abnormalities he was seeing. The Committee considers that the failure at Gisborne Laboratories to ensure that the pathologist participated in an external quality control programme is a factor that is likely to have led to the unacceptable level of under-reporting that occurred at the laboratory.

No Accreditation With An Independent Quality Control Authority

5.28 Throughout the time that Dr Bottrill was in practice Gisborne Laboratories was not accredited with an independent laboratory quality control authority such as TELARC. Even though the requirements for TELARC accreditation were not as demanding in the early 1990s as they are now, they still would have deterred Dr Bottrill from practising as he did. Most importantly, from 1993 onwards, it seems that so long as Gisborne Laboratories employed only one person to carry out all the cervical cytology it would have been denied accreditation. Mr Walker said in evidence:

Chair Question You have talked … about the situation of Dr Bottrill doing all the cytoscreening on his own, in terms of TELARC IANZ accreditation again looking at it from 1993 to 1996, would TELARC accredit a laboratory where a single pathologist was doing all the cytoscreening.

A Very definitely not. I have already indicated …those three laboratories where their cytology accreditation has been suspended, it is as a result of the loss of their last cytotechnologist. So that a single pathologist however competent would not meet our requirements of accreditation.

Q So … one of the things that Dr Bottrill would have had to have done if he wanted to obtain accreditation for the laboratory was to hire a cytoscreener to work with him.

A Or to make arrangements for another pathologist to rescreen his work.

Q Yes.

PROFESSOR DUGGAN INTERJECTS

PROFESSOR DUGGAN: By that comment Mr Walker, it is acceptable to TELARC that gynaecological slides can be screened by a pathologist?

A Solely …by a single pathologist, no.

Q Well no, screened by a single pathologist with the quality control done by another pathologist.

A We would have considered that as an option. It would have been unusual.…

A I don’t know of a pathologist in New Zealand at the present point in time that would have absolute confidence in his or her work without somebody else having reviewed a good percentage of it, that someone else could equally be another pathologist or a cytotechnologist.

5.29 In addition to ensuring that more than one qualified person was involved in cervical cytology TELARC accreditation would have led to improved systems and procedures at Gisborne Laboratories. By May 1991 TELARC had issued recommendations, which had been formulated by the Cytology Advisory Liaison Committee, and which TELARC intended its assessors to discuss with laboratories during accreditation assessments for cytology. These recommendations were not extensive, however, they required:

a recommended process for checking abnormal smear tests;

random rescreening of 10% of negative smear tests;

they identified maximum annual and daily limits for reading smear tests;

they encouraged participation in an external quality control programme; and

they recommended the phasing out of off-site (home screened) smear tests.

5.30 By June 1991 TELARC had issued the New Zealand Code of Laboratory Management Practice. This document, which was produced to the Committee as exhibit BJL/MEDH/5, set out requirements for laboratory practice. These included having in place laboratory quality control procedures; the purpose of which is to demonstrate that accurate and reliable tests are being produced, to anticipate potential sources of error in a laboratory’s operations and to implement checks at appropriate control points to detect any errors that should occur.

5.31 Furthermore, from 1991 TELARC recommended that laboratories accredited for cytology participate in an external quality assurance programme. By 1993 participation in an external quality control programme had become "virtually essential" for TELARC accreditation. When asked to explain what "virtually essential" meant Mr Walker described it as indicating a requirement which an assessment team might impose on a laboratory. And although it was not an absolute requirement in 1993 it was about to become so within a short period of time, so that any laboratory which did not participate in an external quality control programme in 1993 and which wanted accreditation would have had to enrol in such a programme in the very near future if it wanted to obtain or retain its accreditation. Mr Walker told the Committee :

A Historically, in the absence of an appropriate programme of inter-laboratory comparison, the requirement of IANZ, TELARC in those days, for mandatory participation, was not in existence but as those programmes became more and more developed and more and more accepted by the industries participating in them, they became progressively more likely to become requirements of accreditation, the error that we are talking about here was at the point where it was virtually a requirement, a few years before that it would not have been a requirement and very soon after that it became a mandatory requirement.

Q … so when you say virtually essential you are meaning that this is something that in a very short period of time is going to become essential and so you are signalling that to the reader of the letter.

A That’s a very fair assessment of what I intended to say, perhaps I should have used those sorts of words.

Q And so your expectation would be then that the reader takes that phrase at their peril and either does something about it immediately or waits until it becomes an absolute requirement and that that will happen very soon.

A I have every confidence that had Gisborne laboratory taken the next step and been initially assessed, that the peer assessment team would have required participation in that programme and that was my intent and perhaps using the words virtually essential doesn’t appropriately convey that intent.

5.32 Accreditation does not guarantee that laboratories will not under-report an unacceptable number of smear tests. It focuses on the systems and procedures a laboratory uses to achieve its results and not on the substance of the results. What it does is set in place systems and procedures to ensure that a laboratory has appropriately trained staff, well maintained equipment and recognised methods and procedures in place. However, if these systems and procedures are properly followed they should enhance a laboratory’s performance substantively as well as procedurally as they are likely to lead to good quality results and to reduce the opportunities for error.

5.33 Accreditation also creates a culture and an awareness of quality assurance and the benefits to be derived from it. A laboratory which is attuned to the need for quality assurance to improve work performance is less likely to produce errors in smear test reporting than a laboratory where the need for quality assurance is unrecognised. Moreover, the process of obtaining accreditation involves subjecting a laboratory to a full review by a team of experts in the field for which accreditation is sought and thereafter regular inspections. This degree of attention would be likely to bring any risk associated with a laboratory’s performance to notice.

5.34 Had Gisborne Laboratories been accredited with TELARC by the end of 1991 the impact of the CALC inspired recommendations and the New Zealand Code of Laboratory Management Practice combined with the employment of a second person to share the reading of cervical cytology would have improved the systems and the procedures Dr Bottrill followed and this in turn is likely to have reduced his under-reporting to a more acceptable level. Certainly by 1993 accreditation with TELARC would have resulted in improved systems and procedures including the introduction of internal and external quality control and a requirement to share the task of reading cervical cytology with another person. It would have brought to an end the practices that the Committee considers are likely to have led to the unacceptable level of under-reporting. The Committee, therefore, considers that the laboratory not being accredited is a factor that is likely to have led to an unacceptable level of under-reporting.

Inadequate Participation In Continuing Medical Education

5.35 Dr Bottrill’s specialist training was in anatomical pathology. He was appropriately trained in cytopathology given the standards of the time during which he trained, however at that time cytopathology was in its infancy. Since then, cytopathology has evolved and grown, and the practice has become more specialised. Dr Bottrill informed the Committee that he had no specialist qualification in cytology; the examination he sat in the early 1970s to become a member of the College of Pathologists of Australia had no cytology component. Dr Bottrill’s qualifications and experience can be contrasted with recommendations contained in standards the Cervical Screening Liaison Advisory Committee (CSLAC) sent to TELARC in 1995. These standards reveal how the perceived need for pathologists to have training in cytology had increased. They contain a recommendation that pathologists wishing to practise in cytopathology should have a minimum of two years special supervised training. Those pathologists who have the qualifications in anatomical pathology but who lack expertise in cytopathology are advised to undertake appropriate training prior to taking responsibility for cytological reporting in New Zealand laboratories.

5.36 Competence in a changing field is maintained by undergoing additional formal training in an accredited training centre and/or through participation in continuing medical education activities. Dr Bottrill did not undergo additional training. Dr Bottrill’s evidence was that he continued his medical education by: attending approximately six to eight local post graduate meetings per year; biannual attendances at conferences and workshops relating to cytology and histology; attending the cytology sessions of the Royal College of Pathologists of Australasia between the years 1968 to 1993; attending a conference in Mexico of the World Association Society of Pathology in 1993 and a conference by the same organisation in Auckland in 1995; and attending the New Zealand Society of Cytology meetings on numerous occasions, the last being in 1992. He also spent time reading in the library at Gisborne Hospital. It seems from the evidence the Committee heard that Dr Bottrill’s participation in continuing education began to decline in 1993. Furthermore, his participation at the conferences and workshops he did attend does not appear to have made him realise or gain any insight into the risk he was taking by practising as a sole practitioner in cervical cytology, nor did it improve his reading of cervical smear tests.

5.37 The Committee considers that the degree to which Dr Bottrill participated in medical conferences and workshops in the period from 1990 to 1996 was insufficient for him to improve his cytopathology practices. He could have done so by additional formal training, however he never underwent such training. In the Committee’s view more focussed continuing medical education and additional formal training in cytopathology would have brought home to Dr Bottrill the danger inherent in the practices followed at Gisborne Laboratories, and the need to reform the laboratory’s practices. For this reason the Committee considers that the failure of Dr Bottrill to participate in continuing medical education is a factor that is likely to have led to the unacceptable level of under-reporting that occurred.

Lack Of Awareness And Insight As To How The Laboratory’s Practices Put Patients At Risk.

5.38 The Committee considers that another feature of the practice of cervical cytology in Gisborne Laboratories, which was not compatible with the effective or safe delivery of cervical cytology, was that Dr Bottrill had no awareness of or insight into the extent to which the laboratory’s practices put patients at risk. In his evidence to the Committee he said:

"I think if I were doing it again I wouldn’t make any major changes. I was completely unaware at the time that I retired that there was a problem".

5.39 This lack of awareness and insight as regards the risk inherent in his practice of cervical cytology probably explains why Dr Bottrill continued to read cervical cytology on his own until his retirement in March 1996, and why he failed to have in place any measures to reduce the risk of practising in this way. Dr Bottrill’s view on his practice at Gisborne Laboratories is completely at odds with the evidence the Committee has heard from experts on how a laboratory should carry out cervical smear test screening and the inherent dangers when carried out by a sole practitioner. He refused to accept that the following features of his practice contributed to his under-reporting:

his lack of expertise in cytopathology and primary screening;

his lack of appropriate continuing education;

the laboratory’s failure to take timely steps to get accredited;

the laboratory’s failure to institute appropriate internal and external quality control;

the laboratory’s failure to institute a system of peer review; and

the laboratory’s failure to have systematic look-back procedure for patients.

This attitude of Dr Bottrill only confirms for the Committee his unawareness of and lack of insight into the risks his practice posed to patients.

Factors Relating To The Delivery Of Cytological Services In New Zealand Between 1990 And March 1996

5.40 From the years 1990 to 1996 cytological services in New Zealand were delivered in circumstances where:

Laboratories reading cervical cytology were not required to follow quality control processes or to be accredited with an independent quality control authority;

The Government Policy for National Cervical Screening (1991) and the 1993 updated version in relation to laboratories reading cervical cytology were not well designed;

The National Cervical Screening Register was not functioning optimally;

There were no performance standards for laboratories, and there were no reliable data on laboratories’ performance;

There was no monitoring and evaluation of the performance of laboratories reading cervical cytology;

The health authorities did not take heed of the warnings provided by the failures of screening programmes in other countries;

There was a failure to ensure all components of the programme where in place from an early stage.

All of this is indicative of a failure to design and deliver a soundly based cervical screening programme. The Committee has already identified the factors relating to the practice of cytology at Gisborne Laboratories that it considers are likely to have led to the unacceptable level of under-reporting that occurred at that laboratory. The Committee considers that but for the failure to deliver a soundly based cervical screening programme the cytology practices at Gisborne Laboratories could not have continued for as long as they did. If the factors, which the Committee considers the Programme lacked, had been operative the practice of cervical cytology at Gisborne Laboratories would have been improved or come to an end. Either way the risk of unacceptable under-reporting would have been considerably reduced. Thus the Committee considers that the failure to deliver a soundly based cervical screening programme is a factor that is likely to have led to the unacceptable under-reporting that occurred in the Gisborne region. The Committee’s reasons for reaching this view are set out below.

No Compulsory Quality Control

5.41 Compulsory quality control including accreditation for all laboratories reading cervical cytology was not introduced until some time in late 1996. It is difficult to be precise about when these requirements were introduced as their introduction into individual laboratories was achieved at different times and through more than one mechanism. What is clear is that before this time quality control (and accreditation) was not mandatory, even though the need for quality control of laboratories reading cervical cytology for a cervical screening programme was seen as essential by more than one authoritative source from as early as the mid- nineteen eighties. A review of some of the authoritative material is set out below.

5.42 The 1986 Bulletin of the World Health Organisation on Control of Cancer of the Cervix Uteri recognised the need for quality control to reduce the occurrence of false negative reports. It said:

" Quality control systems must be developed in cytology laboratories to keep the number of false negatives reports as low as possible." (Emphasis added)

5.43 In 1988 a Department of Health publication titled Towards a More Effective Cervical Screening Service for Women recognised the need to develop quality control measures in laboratories reading cervical cytology. It said that:

" A review of laboratory services for cervical cytology is required. This review will need to include the development of quality control measures to ensure that cytological services in laboratories maintain a consistently high standard."

In its submission to the Committee the Ministry of Health said that this publication demonstrated that the Department of Health was "well aware of the issues surrounding quality relating to a national [screening] programme, including the key issues surrounding quality in laboratories."

5.44 In November 1989 the Report Of The Ministerial Review Committee On Implementation Of A Government Policy for National Cervical Screening was published. Section 8 of the report covered smear readers and standards of competency. It began by noting that:" Laboratories and their staff will play a key role in the success of any cervical screening programme, as it is principally through them that cytological information will be collected and recall dates established." Sections 8.10-8.13 set out the importance of quality controls to ensure consistency in the reporting of cervical smears.

5.45 In July 1990 Dr Judith Straton of Division of Public Health University of Western Australia was engaged by the Department of Health to review of the National Cervical Screening Programme. She produced a document titled Review of the Government Policy for National Cervical Screening in which review she wrote:

"Aspects of the laboratory services which need attention include accreditation and quality control. …It seems that the accreditation of laboratories by the national laboratory accreditation organisation (TELARC) is on a voluntary basis and only a relatively small number of laboratories are accredited. I have not seen the criteria for accreditation used by TELARC but I understand that they do not at present cover all the necessary areas. I believe that there should be a system of accreditation of laboratories carrying out cervical cytology screening, which is tied to the reimbursement of laboratories for reading smears. Public hospital laboratories should also be included." (emphasis added)

5.46 In August 1990 an experts groups which had been established in December 1989 to advise the Minister of Health on national policy and resource allocation for the National Cervical Screening Programme presented a report titled Policy Statement Of The Government Policy for National Cervical Screening Expert Group. Section 12 of the report dealt with laboratories. The report acknowledged that: "The efficiency of the cervical screening programme will depend on high standards of smear reading by laboratory technicians and an acceptable turn-around time for reporting on smears. " In section 12.2 the report set out a proposed implementation strategy for the programme in relation to laboratories. This provided:

"Section 12.2.2 The expert group recommends that by 1991 all cytology laboratories serving the National Cervical Screening Programme should have applied for registration with the testing Laboratory Registration Council of New Zealand (TELARC) and should be TELARC registered by December 1993. The only exceptions will be if TELARC itself is unable to meet these deadlines or if a laboratory is newly set up, necessitating a reasonable period of time in which to obtain TELARC registration.

12.2.3 The Department of Health should be responsible for confirming that those laboratories carrying out cytology screening for the National Cervical Screening Programme meet the recommendations set out in 12.2.2. Such confirmation should become a requirement for receiving the laboratory benefit for reading National Cervical Screening Programme smears.

12.2.4 The criteria for registration by TELARC should be negotiated with TELARC by CALC and the Department of Health. The criteria will include guidelines on :

The reading of a minimum number of smears a year;

The employment of adequate numbers of suitably qualified staff;

The maximum workload for each cytoscreener;

Adequate in-service education;

A satisfactory participation of both internal and external quality assurance procedures;

Co-operation in providing cytology reports to the cytology register.

12.2.5 The Department of Health, CALC, TELARC and other relevant organisations will seek standards for the training of cytology laboratory assistants. The Department of Health is responsible for ensuring that there are sufficient training facilities to meet the cytology screening workforce requirements of the National Cervical Screening Programme.

12.2.5 Developing a mechanism for linking the histology results of cervical tissue submitted to laboratories for diagnosis to the cytology register is an urgent priority for the Department of Health. The register will also be developed so that laboratory staff have direct access to a woman’s previous smear history when reading smears.

5.47 In July 1991 a report was published in the New Zealand Medical Journal titled Cancer Screening 1991 Cervical Screening Recommendations: A Working Group Report. The report commented on the need for quality control of all aspects of cervical screening including laboratory performance:

" Quality control of all aspects of cervical screening should be a major emphasis of the National Cervical Screening Programme. To provide proper quality control there should be formal evaluation of all the components of the screening process from recruitment and recall of women to management of women with abnormal smears. A national register is the essential management tool to allow this and should be expanded to include the relevant histology results ensuring correlation and evaluation of cytology findings. Health educators, smear takers, laboratory staff, computer staff, colposcopists and therapists should all be appropriately trained and qualified. Laboratories and sites for therapy should be accredited . Legislation is essential to allow all laboratories to provide both cytology and histology results to the register."(emphasis added)

5.48 In 1991 the Government Policy For National Cervical Screening (1991) was issued. This was the first written policy for the Programme. It was prepared by the Department of Health and approved by the Associate Minister of Health. The Policy was based on the recommendations that were made in the August 1990 report of the Expert Group. Part 4 of the Policy defined the role of laboratories in the implementation of the Programme and the expectations of their performance in this role. Part 4 incorporated most of the recommendations, for quality control of laboratories, that appear in section 12 of the Expert Group’s report. It anticipated laboratories being accredited with TELARC or a similar authority by 1993; and it described the criteria for accreditation. This included: having a set minimum number of smears for reading each year; employing adequate numbers of suitably qualified staff; having maximum workloads for each cytoscreener; making provision for adequate in-service education; participating in internal and external quality assurance procedures and providing cytology reports to the cytology register.

5.49 It seems that pathologists were not in general resistant to compulsory accreditation. The minutes of a meeting of the Cervical Screening Advisory Committee held on 12 December 1991 record the committee’s discussion on how to enforce accreditation of laboratories. Dr Clinton Teague, pathologist, is recorded as saying that he did not think that accreditation would be a big problem as most laboratories were moving towards accreditation, and that compulsory accreditation had been accepted by laboratories as they had had sufficient time to gain accreditation. He is also recorded as referring to the Australian position where laboratories had to be accredited to claim Medicare subsidies. The Committee has not seen any material or heard any evidence in the course of its inquiries that would suggest that pathologists would have strongly resisted the introduction of compulsory accreditation by making receipt of government funding conditional on accreditation.

5.50 In 1992 the World Health Organisation published the Cervical Cancer Screening Programmes’ Managerial Guidelines. In discussing technical resources for cytological examination the guidelines state :

"Before a screening programme is started the resources must be in place for taking the smears and a cytology laboratory must be accessible to examine and report on the smears. To ensure that the laboratory services are both efficient and cost effective they should be centralised, each laboratory being supervised by a fulltime cytolopathologist with an organised system of quality assurance and continuous education of cytotechnologists. (emphasis added)

Later in the Guidelines there is a reference to an earlier World Heath Organisation publication of 1988 dealing with laboratories in which it was recorded that: " The laboratory must have adequate quality control procedures in place for cervical cytology."

5.51 All of the above shows that at an early stage in the development of the Nation Cervical Screening Programme there was authoritative material from international and national sources on the importance of quality control in laboratories reading cervical cytology for screening programmes. The various reports to the Minister and the Department on the establishment of a cervical screening programme all recognised the importance of quality control. Furthermore, the inclusion of quality control provisions in the Policy in 1991 shows that by then the Minister and the Department had accepted quality control was important. Moreover, the Committee was not referred to any material which suggested that the use of quality control processes in laboratories reading cervical cytology was unnecessary.

5.52 The Committee’s view was confirmed by the evidence of Professor McGoogan. She was critical of the failure to have quality controls in place from the outset. She was shown a flow diagram that was appended to the draft report of the National Cervical Screening Workshop of 1988. This flow diagram recorded the points in the Programme at which quality control and evaluation needed to occur. Professor McGoogan considered the diagram was a good starting point for implementing quality control, but that it did not go far enough. When asked to give her opinion on the Programme’s failure to adopt the diagram of quality controls and its lack of any quality controls on laboratory performance up to 1996 her response was:

" I would be extremely disappointed because by the time the New Zealand Programme was implemented the need for quality control and evaluation for a screening programme of any kind was well recognised.

Professor McGoogan considered that if quality controls were not in place from the outset that they should have been in place by the end of the first cycle of the programme, that is: three years after its commencement and for good data to be collected from that time onwards.

5.53 It seems to the Committee that the necessity of quality control processes for reading cervical smear tests for a screening programme is incontestable. This is not an idea that has only recently become accepted. The literature to support this view has been available for many years and certainly some of it pre-dates the National Cervical Screening Programme. Furthermore the logic of the necessity for quality control is readily apparent. One significant difference between laboratory diagnostic testing for a screening programme and laboratory diagnostic testing to discover a suspected ailment is that in the latter case the patient is unwell and presents with signs and symptoms. Because the patient is unwell there is bound to be further investigation, if the laboratory misdiagnoses the test, and this should ultimately lead to the correct diagnosis. None of this applies to a screening programme. A screening programme involves large numbers of healthy women. The whole purpose of a screening programme is to detect pre-cancerous abnormalities, which are generally asymptomatic. This means that a woman who is referred for a cervical smear test will usually not be displaying any signs. If her smear test is misdiagnosed there is nothing to alert her or her medical practitioner to that possibility. It, therefore, seems obvious to the Committee that there are, and always have been, more pressing reasons for having quality control processes in laboratories reading cervical cytology for screening programmes than in respect of other diagnostic services. So that, even though during the period under review general laboratory services were not subject to compulsory quality control or accreditation requirements, there was good reason to treat cervical cytology differently. Compulsory quality control and accreditation of laboratories reading cervical cytology should have formed part of the National Cervical Screening Programme from the outset. The Committee understands that some laboratories could not have become accredited immediately. However, those laboratories could have been accommodated by specifying a lead-in period with a definite expiry date after which only accredited laboratories would be eligible to receive funding for reading cervical cytology.

5.54 In 1993 the Policy was updated to accommodate the structural changes in the health sector. Part 4.1.2 which set out the expectation that laboratories would gain TELARC accreditation by 1993 was amended by removing the indirect reference to this date and replacing it with an expectation that accreditation should be achieved within a reasonable period of time. This weaker statement placed less pressure on laboratories than the earlier expectation, which at least attempted to place a time limit on the move towards accreditation. At the same time in 1993 the European Community had issued guidelines on cervical screening which recognised the importance of quality control in laboratories. Section 7 of the European Guidelines For Quality Assurance In Cervical Cancer Screening, which covers quality assurance in the cytology laboratory, stated:

"Quality assurance in cervical cytology is designed to achieve an acceptable reliability and consistency in the results produced in the cytology laboratory."

Then after defining the terms "internal quality assurance" and "external quality assurance" the Guidelines continued: "We consider that both schemes are essential for sound laboratory practice "(emphasis added). The Guidelines also recognised the need for accreditation of laboratories with an independent quality control agency:

"Accreditation is assessment of standards by a panel of experts. The assessment will entail a visit to the laboratory to inspect working conditions and assess working practises such as staff workload ratio, quality assurance measures, health and safety preconditions, arrangements for staff training, quality of record keeping, arrangements for follow up of abnormal smears etc"

5.55 It was not until late 1996 that compulsory accreditation for cervical cytology was imposed; and then it occurred in a piecemeal fashion as each of the four Regional Health Authorities was able to conclude a contract (including compulsory accreditation) with the diagnostic laboratories which provided it with services. In the case of the Gisborne region the service contract between Midland Regional Health Authority and Gisborne Laboratories, was not executed until March 1997. This was nine years after the Department of Health had first recognised the need to develop quality control measures to ensure laboratories reading cervical cytology maintained a high standard.

5.56 The Ministry of Health has submitted to the Committee that there are good reasons why it took so long to introduce compulsory quality control through requiring laboratories to be accredited with IANZ or a similar body. These reasons and the Committee’s views on them are dealt with in the discussion on Term of Reference Three, which looks at systemic problems with the National Cervical Screening Programme. For the purpose of answering Term of Reference Two the Committee considers that it is necessary only to report on those factors that it considers are likely to have led to under-reporting. The Committee has already described the benefits of quality control and laboratory accreditation and the effect they would have had on the practice of cervical cytology at Gisborne Laboratories. Because it considers that compulsory quality control (either through TELARC accreditation or a scheme with similar features which the Department imposed directly as a condition of payment) would have prevented Gisborne Laboratories from continuing to practise as it did, the Committee has concluded that the failure to make quality control and laboratory accreditation compulsory by 1993, at the latest, is a factor that is likely to have led to the under-reporting in the Gisborne region, 1993 being the chosen year in the 1991 Policy for laboratories to have gained accreditation. The Committee is aware that mistakes can still occur in accredited laboratories, and that accreditation is not a complete answer to avoiding laboratory errors. In this case, however, accreditation would have stopped those practices at Gisborne Laboratories that led to unacceptable under-reporting.

Design Faults Of The Government Policy For National Cervical Screening (1991) As It Related To Laboratories Reading Cervical Cytology

5.57 The laboratory component of the 1991 Policy and the updated 1993 version was set out in clause 4 of both documents. It was much the same as the recommendations for laboratories reading cervical cytology in section 12 of the Expert Group’s report of 1990. Clause 4 provided

"4.1.2 All cytology laboratories servicing the National Cervical Screening Programme should be registered with the Testing Laboratory Registration Council of New Zealand (TELARC) or other recognised authority. It expected that laboratories not so registered will apply and gain such registration. A reasonable period of time will be allowed for laboratories to obtain registration. This may take up to two years.

4.1.3 The Department of Health will be responsible for confirming that those laboratories carrying out cytology screenings for the National Cervical Screening Programme meet the requirements set out in 4.1.4.

4.1.4 The criteria for registration by TELARC or other recognised authority will be established by the cytology advisory liaison committee. The Department of Health will be consulted. The criteria will include :

Reading of a minimum number of smears a year;

Employment of adequate numbers of suitably qualified staff;

Maximum workload for each cytoscreener;

Adequate in-service education;

Satisfactory participation in both internal and external quality assurance procedures;

Provision of cytology reports to the cytology register.

4.1.5 The Department of Health, the Cytology Advisory Liaison Committee, TELARC and other relevant organisations will monitor standards for the training of cytology laboratory assistants."

5.58 The Committee has already discussed in the preceding paragraphs the importance of quality control, including laboratory accreditation. Here, the focus of the Committee’s interest is on the special accreditation for laboratories reading cervical cytology that was planned in clause 4 of the Government National Cervical Screening Policies issued in 1991 and 1993. The clause specified a number of criteria for inclusion in TELARC’s general criteria for accreditation. These were additional criteria which the Policy intended the Cytology Advisory Liaison Committee (CALC) to develop in consultation with the Department and then for TELARC to apply them when it came to accreditation of laboratories reading cervical cytology. Clause 4 demonstrates the Policy’s intent to shape the criteria for TELARC accreditation for laboratories reading cervical cytology to include requirements which had been recognised overseas as being beneficial to the success of a screening programme. Three paragraphs of clause 4 are significant; these are:4.1.2; 4.1.3 and 4.1.4

5.59 Though the inclusion of clause 4 demonstrates that the Minister and the Department recognised the importance of quality control for laboratories, and that the intent of the Policy was for laboratories servicing the Programme to be accredited with an independent quality control authority, the poor design of the Policy did nothing to guarantee that occurred. Paragraph 4.1.2 did no more than to state that laboratories "should be" registered with an accreditation authority. This is different from stipulating that laboratories must be accredited. There is nothing in the language of paragraph 4.1.2 that compelled the Department to ensure a laboratory became accredited. The paragraph does no more than exhort laboratories to gain accreditation. In the Committee’s view, once the importance of accreditation was accepted, and provision made for it in the Policy, the design of the Policy should have ensured that accreditation would happen.

5.60 In the 1991 Policy paragraph 4.1.2 contained an expectation that laboratories that were not accredited would be given a reasonable period of time to do so, (up to two years). This expectation was ineffective. If laboratories resisted or were dilatory in taking steps to gain accreditation there was nothing that the Department could do under the Policy, or otherwise, to compel them to become accredited. This was so, even though diagnostic laboratories reading cervical cytology were fully paid for this service from government funds. The Committee comments in its report on Term of Reference Three on the Ministry of Health’s explanation for how this came about. What the Committee is concerned to report on here is its view that a well designed cervical screening policy is one which recognises the need for quality control and accreditation of laboratories and is designed to ensure these features are in place. The 1991 Policy could not do this. This is one of the reasons why the Committee considers the 1991 Policy to be poorly designed. Compulsory accreditation, based on the criteria in paragraph 4.1.4, would have brought the practices followed at Gisborne Laboratories to an end. In so far as the Policy permitted Gisborne Laboratories to continue to practice its poor design is a factor that is likely to have led to the under-reporting at Gisborne.

5.61 The criteria in 4.1.4 are important. For example: the criterion regarding a minimum number of smears per annum. In 1991 and up to the time of Dr Bottrill’s retirement Gisborne Laboratories was reading no more than 5000 smears per year. At the time the internationally recommended minimum number was well in excess of this number. The World Health Bulletin on Control of Cancer of the Cervix Uteri had stated in 1986 that:

"Cytology services should be centralised. A large volume of work contributes to the successful operation of a cytology laboratory because a specialised division of labour is possible and a large number of abnormal smears representing various pathologies will help to maintain the cytotechnologists skills. In general laboratories that screen fewer than 20,000 specimens annually are not cost-efficient and cannot support either a training programme or a full-time cytotechnologist Preferably the annual number of specimens should be 50,000 or more.

A publication from the Council On Scientific Affairs, American Medical Association JAMA 1989 Quality Assurance In Cervical Cytology( exhibit RGB/MOH/3) reported that the American Society of Cytology would only accredit laboratories that received a minimum of 10,000 gynaecologic smears per annum or maintained staff of at least one cytopathologist and one full time cytotechnologist.

5.62 In the Review of the National Cervical Screening Programme, which was written in 1990, Judith Straton reported on the need for setting a minimum number of smear tests. She saw no practical difficulty in implementing this requirement as she considered that smear tests could be easily transported to those laboratories which were reading a large number of smears and which could meet a compulsory minimum requirement. She realised that a compulsory minimum number would exclude some laboratories from reading cervical cytology but it appears to the Committee that in her view this would only benefit the Programme. She said:

" The issue of the minimum number of screening smears which are essential to maintain a competent screening service is one which needs to be addressed. Apparently there are laboratories in New Zealand which are reading fewer than 50 smears per year, compared with the minimum in the Untied Kingdom of 15-20,000 smears per year. Obviously with a smaller and more scattered population one may not be able to use quite such stringent criteria, but communications in New Zealand are good and smears can easily be sent from place to place. This problem needs to be addressed urgently. It would be very difficult for laboratories reading as few as 50 smears per year to maintain a suitable level of competence or have any systematic quality control, and this issue must be faced. Women have the right to expect a minimum level of competence in the reading of their smears."(emphasis added)

5.63 From the material the Committee has seen it is clear that everyone working with the Programme thought, in principle, that a compulsory minimum number of smears was needed to maintain screeners’ competence. And, that 5000 smears per annum was a low number of smears to read in order to maintain competence. However, by setting a minimum number the Programme would have excluded some laboratories, including hospital laboratories, from reading cervical cytology. In New Zealand cervical cytology had always been read by any laboratory that wanted to do so. Furthermore, there was no history of the Department or the Ministry of Health preferring certain laboratories to others when it came to funding for diagnostic services. Therefor, the setting of a minimum number required a major change in approach. It seems to the Committee that ultimately the issue was too difficult to face and nothing was done, even though the Policy intended a minimum number of smears to be set and everyone recognised the benefits of laboratories which read a large number of smear tests. Once again the Policy had no means of ensuring that its intent was achieved.

5.64 The issue of setting a compulsory minimum number of smears for reading per year was finally faced in 2000 by the Health Funding Authority when, in its proposed standards for laboratories reading cervical cytology, it proposed a minimum of 12,000 smears per year. The rationale behind setting a minimum number of smears per annum is that unless a laboratory processes a sufficient number of smears the screeners cannot maintain their competence. Simply by ensuring that a set minimum number of smears for reading each year (which reflected international minimum numbers) was actually in force the Policy would have excluded Gisborne Laboratories from reading cervical cytology.

5.65 Clause 4.1.3 placed the responsibility on the Department of Health to confirm that laboratories carrying out cytology reading for the policy met the requirements of 4.1.4. However, as accreditation was not compulsory clause 4.1.3 had little effect, and the evidence is that the Department of Health did little to ensure that laboratories met the requirements set out in 4.1.4.

5.66 The Committee heard evidence from Mr Mules, the former Chief Executive of the Midland Regional Health Authority. He had previously been employed as the General Manager of the Bay of Plenty Area Health Board. In this capacity he would have had experience of how the Policy of 1991 worked in relation to area health boards. He had also undertaken work for the Health Reforms Directorate of the Department of Health. He appeared to the Committee to be a witness who was informed about the Programme and how it functioned prior to the health restructuring in 1993. He told the Committee that one of the aims of the Programme prior to 1993 had been to introduce quality standards for laboratories reading cervical cytology but that the method by which such standards would be enforced was unclear to him as in his view there was no appropriate accountability structure in place:

"One of the aims of the National Cervical Screening Programme was to introduce quality standards around the reading of slides by pathologists, a process that requires the pathologist to exercise their professional judgement after actually viewing the slide and cannot be automated. Those aims were explained under the heading "Laboratories" at page 5 of the 1991 Policy". …

Mr Mules then referred to the 1991 Policy, which stated that the Department of Health would be responsible for confirming that laboratories carrying out cytology screening met TELARC requirements and said:

"To my knowledge this was the first time that an attempt was made to have private laboratories agree with an external agency (in this case Department of Health) to develop and implement quality standards. How this is to be enforced in the absence of an appropriate accountability structure is unclear." (emphasis added)

5.67 Mr Mules evidence on the 1991 Policy confirms for the Committee the impression it gained from other evidence that the 1991 Policy was designed without any provision put in place to enforce the Policy, should the need arise. The overall tenor of the Policy as regards laboratories is to set out statements that essentially describe good practice and then to leave it to the good will of the laboratories to respond to these exhortations. In the Committee’s view this is insufficient. A well designed Policy should require laboratories to practise quality control and to be accredited with an appropriate authority, and it should ensure that there is a means of compelling laboratories to comply with the Policy’s intent if they fail to respond.

5.68 When the Policy was updated in 1993, to take into account the structural changes in the delivery of health services, the amendments to clause 4 only exacerbated its poor design. It has already been noted in the report that the two year time frame within which accreditation was expected to be achieved was removed. More importantly, the division of responsibility in the updated Policy between the new Ministry of Health, (which had replaced the Department of Health), and the four new Regional Health Authorities, (which had assumed much of the Department of Health’s operational responsibilities), was poorly designed. This was so even though the updated Policy described itself as being:

" revised and updated to accurately reflect the structural changes to the health sector, the changes to the National Cervical Screening Programme and Register… The purpose of this revision is to update the policy for regional health authorities, the Public Health Commission and for cervical screening programme managers and service providers. The update makes no changes to the goals, objectives, or targeting sections of the 1991 policy document."

The wording of clause 4 remained the same except that the Ministry of Health was substituted for the Department of Health and the statement in clause 4.1.2 that TELARC accreditation may take up to two years was removed. No account appears to have been taken of the new policy-making and advisory role of the Ministry and its reduced ability to carry out operational activities. This change from a government department to a ministry with a policy-making role meant that the new Ministry of Health was less well placed than the Department of Health to carry out the role clause 4.1.3 gave to it.

5.69 The Ministry did consider whether it was appropriate for the Programme to remain with the Ministry, given its role in the new health structure. An internal memo of 18 March 1993 from Sonja Easterbrook-Smith to the Director-General acknowledges that the role of nationally co-ordinating the Programme was anomalous in a policy advice Ministry. Nevertheless, a decision was made to retain that role, and the responsibilities the Policy of 1991 had imposed on the Department of Health, within the Ministry. Once a decision was made to retain those features of the Programme within the Ministry, the 1993 updated Policy should have been designed to ensure that the effective delivery of the Programme was not compromised by any resulting anomaly.

5.70 Ms Judith Glackin, who gave evidence for the Ministry of Health, told the Committee that the Ministry could not carry out the role of confirming that laboratories met the criteria in 4.1.4 as the Ministry had no means of discharging this task. She said that the Ministry sought, instead, to discharge this task by ensuring that laboratories were TELARC accredited:

"Paragraph 4.1.3 could be read as intending that the Ministry would in some way be responsible for confirming that laboratories were meeting all the criteria required for TELARC registration. This was clearly not possible, as the Ministry had no direct relationship or influence over laboratories after RHA [ Regional Health Authority] contracts replaced the previous payment arrangements under Part II of the Social Security Act 1964. Ensuring that laboratories were accredited by TELARC or another suitable quality assurance programme was seen as the way of ensuring that laboratories met quality standards.

However, the evidence shows that the Ministry did nothing to ensure that laboratories were TELARC accredited. All that it did was to include in its funding agreements with the regional health authorities a provision that they use " reasonable endeavours to ensure" laboratory accreditation. To ensure something is done is to make certain, to secure or to guarantee that it is done. Requiring regional health authorities to use their "reasonable endeavours to ensure accreditation" does not amount to making certain, guaranteeing or securing accreditation. Thus the Ministry failed to discharge its responsibilities in clause 4.1.3, however that clause may be interpreted.

5.71 The Ministry’s inability to perform the role clause 4.1.3 placed upon it was recognised by the Cytology Liaison Advisory Committee. In June 1994, when the 1993 Policy was being reviewed, this committee commented in a submission for the review that:

"The Ministry of Health does not have the expertise and nor would it seem an appropriate function of the Ministry of Health to confirm that laboratories were meeting detailed requirements relating to TELARC accreditation."

However, because of delays in the completion of the policy review the wording in the 1993 Policy remained unchanged until a new Policy document was issued in June 1996. This was after Dr Bottrill’s retirement.

5.72 Ms Glackin referred to the 1994/95 Funding Agreements between the Ministry and the Regional Health Authorities which required the authorities to use their "reasonable endeavours to ensure" that all laboratories providing laboratory services for cervical cytology and histology were registered with TELARC or an equivalent quality assurance programme. She said that these funding agreements were between the Minister and the Regional Health Authorities and that they were "the primary accountability documents".

5.73 All the funding agreements from 1994 until 1997/98 refer to the 1991 Policy, even though that Policy was based upon a health structure of a Department of Health and 14 area health boards. The Committee received no explanation for why the funding agreements referred to the 1991 Policy. Although the 1993 Policy had been updated to make specific reference to the new health structure involving the Ministry of Health and the regional health authorities the funding agreements failed to record this. By the 1997/98 funding agreement a new policy had been published in 1996 and the 1997/98 funding agreement referred to the new Policy. The Committee was told that, the performance monitoring branch of the Ministry of Health – which was the branch responsible for issuing the funding agreements – was not advised about the updated version and so until 1996 the funding agreements referred to the 1991 Policy. Although the funding agreements may have referred to the 1991 Policy, from the evidence it appears that everyone understood that it was the 1993 updated version that applied. It would have been difficult to apply the 1991 Policy after the health restructuring as that Policy allocated responsibilities to the Department of Health and the area health boards.

5.74 Clause 10.4 of the 1994/95 funding agreement read :

"10.4 The RHA agrees to use its reasonable endeavours to ensure

10.4.4 All laboratories providing laboratory services for cervical cytology and histology -

(b) are registered with TELARC (the Testing Laboratory Registration Council of New Zealand) or an equivalent quality assurance programme;" (emphasis added)

Clause s4.11.5 of the 1995/96 funding agreement and clause s5.3.20 of the 1996/97 funding agreement also repeated this requirement. However, in addition to these clauses, clause 10.3 of the 94/95 funding agreement, clause 4.11.4 of the 95/96 funding agreement and clause 5.3.19 of the 96/97 funding agreement, provided that the National Cervical Screening Programme, and the cervical screening services, were to be consistent, inter alia, with the Government Policy for National Cervical Screening (1991).

5.75 Ms Glackin accepted that the impact of clauses 10.3, 4.11.4 and 5.3.19 was to incorporate the 1991 Policy document as a term of the funding agreement :

"Q It seems that the 1991 Policy was actually incorporated into the funding agreements for 94/95?

A Yes, that is how it reads.

Q And if you would turn next to the funding agreements 95/96 and go to page 112, … once again the 1991 policy document is made a term of the funding agreement is it not?

A It is

Q Anyone reading the funding agreements seeing that the 91 Policy was part of the funding agreement and going to the 91 Policy para 4.1.3 would conclude that the Ministry of Health would be responsible for confirming that the laboratories met the requirements set out in 4.1.4?

A Yes.

Q And I understand your evidence is that practically speaking, because the Ministry had no direct relationship or influence over laboratories, it couldn’t discharge its responsibility which it had under 4.1.3 of the Policy?

A The mechanism available to the Ministry was through the Regional Health Authority funding agreement and as you have pointed out that referred to the 91 Policy so yes it would appear that was the case.

Q So it seems then that the Ministry … knowingly allowed itself to be placed in a situation where it could no longer responsibly carry out its responsibilities under 4.1.3.

A I believe that’s the case and I think the problem associated with this is the one I refer to later in my brief, which is a delay in the review of the Policy. At the time the Policy was reviewed in 1993 it was envisaged that the review would be completed in 1994, in fact it was not completed until 1996 which meant that the Policy stood as it had been originally worded.

5.76 This means that, although the updated 1993 Policy intended the Ministry to be responsible for confirming that laboratories carrying out cytology screening for the Programme met the accreditation criteria in clause 4.1.4, this could not be done and, therefore, it was not done. Ms Glackin accepted that there was nothing about clause 4.1.3 which was ambiguous about the responsibility it conferred on the Ministry. She accepted that on reading the Policy document it appeared the Ministry was responsible for carrying out clause 4.1.3.

"Q The Policy document says the Ministry of Health will be responsible and is it fair to say on reading 4.1.3 there is nothing ambiguous about that responsibility?

A There is nothing ambiguous about the wording, the problem there was no apparent way in which that responsibility could have been carried out."

Thus the 1993 updated Policy, produced by the Ministry of Health, gave to the Ministry a role which it could not fulfil. Hence, between 1993 and 1996 the intent of the Programme's policy document did not reflect the reality of the Programme’s delivery.

5.77 Mr Mules gave evidence on the 1993 Policy which suggested to the Committee that the Midland Regional Health Authority’s understanding of its responsibilities to the Programme was confused by the difference in the allocation of responsibility in the Policy and the Funding Agreements. He said that the Midland Regional Health Authority had not treated the laboratory component of the Programme as a priority because it considered that it was the Ministry’s responsibility. He described the 1993 Policy in this way:

"The responsibilities of the Ministry of Health, the Regional Health Authorities, Public Health Commission, Cervical Screening Advisory Committee and the Cytology Advisory Liaison Committee are explained at page 8 of the 1993 Policy. The responsibility of the Ministry of Health for introducing quality standards around the reading of slides by pathologists was continued from the role of the Department of Health in the 1991 Policy."

For the Regional Health Authorities the specific laboratory component of the National Cervical Screening Programme was a relatively low priority because we believed that the Ministry was responsible for it. Our National Cervical Screening Programme priorities were enrolment of women, improving access to screening and treatment services, and ensuring collection and communication of data from the local programme directly to the Ministry."

5.78 Later in his evidence Mr Mules confirmed his views on the relationship between the funding agreements under which the regional health authorities were operating and the Government Policy for National Cervical Screening. He said :

"Between 1991 and 1996 the Department/Ministry of Health was responsible for laboratory quality in respect of the National Cervical Screening Programme, covering both definition of the criteria for TELARC registration, and confirmation of which laboratories were eligible to carry out National Cervical Screening Programme screening work. The Department/Ministry also controlled the data from the National Cervical Screening Programme Register that allowed comparative monitoring and analysis of laboratory activity. Midland did not have such access."

5.79 When Mr Mules was asked whether or not, to his knowledge, the Ministry was aware that the Midland Regional Health Authority did not consider itself responsible for confirming whether or not laboratories were TELARC accredited, his response was that it was commonly understood amongst all parties that the Regional Health Authority focus was on enrolment and colposcopy in respect of the Programme.

"Q I want to be clear then, you can only give evidence of your experience of dealings with the Ministry during this time, but from your dealings with the Ministry did you gain the impression that the Ministry was aware Midland Regional Health Authority believed because of the cervical screening policy in 4.1.2 and 4.1.4 that the laboratory component of the Programme was the responsibility of the Ministry.

A If you are referring to those aspects of the laboratory components as described in 4.1.2 to 4.1.5, yes. I was never party to any discussions that would have made people think otherwise. We were responsible in the context of moving from section 51 to laboratory contracts that would have introduced TELARC registration, but that was in a generic sense.

Q As I read your evidence you are saying the Regional Health Authority believed the Ministry was responsible for the laboratory component of the screening Programme.

A Yes, as laid out in Policy guidelines.

Q The point is if that was the understanding of the Regional Health Authority, then whether or not there was any monitoring and evaluation of the laboratory component of the Programme would depend very much on whether the Ministry recognised that it was responsible for that part of the Programme, wouldn’t it?

A Yes, it would depend on their interpretation of the Cervical Screening Policy and the funding agreement.

Q What I am trying to find out from your knowledge is whether or not the Ministry was aware of the Regional Health Authority view.

A I’ve got no reason to believe that they weren’t, and Jane Hudson was in frequent communication with the national co-ordinator and as you’ve seen from the service requirement definition Jane has carried forward the Policy into those documents. I would have thought she would not have done that if she had a contrary view.

Q The outcome would be if the Regional Health Authority relying on the documentation believed the Ministry was responsible for the laboratory component of the Programme in terms of monitoring and evaluation, but if the Ministry itself believed that it couldn’t carry that out as heard from Ms Glackin, it would really mean no-one was doing the job, wouldn’t it?

A One can assume that.

5.80 Mr Lambie was responsible for the unit that prepared and negotiated the funding agreements. He was asked to comment on Mr Mule’s evidence about the regional health authorities’ understanding of their obligations under the funding agreements. Mr Lambie accepted that there was some ambiguity between for example clause 10.3 and 10.4 of the 94/95 funding agreement, however, he said that no regional health authority had taken this up with the Ministry at the time the agreements were being negotiated:

"Q …if you go to 10.3… it says the regional health authority is to purchase cervical screening services …this Programme and the cervical screening services are to be consistent with … the government’s 1991 policy for national cervical screening. And then under 10.4 it says the regional health authority is to use reasonable endeavours to ensure a number of things including TELARC accreditation...I think the difficulty is that in 10.3 there is the reference to the purchasing of service being consistent with the government's’1991 Policy. So I think what Mr Mules was saying, well under the 1991 Policy certain responsibilities remained with the Ministry …in terms of paras 4.1.2 to 4.1.4 of the Policy therefore you you’ve got a tension within the funding agreements between, by incorporating the 1991 Policy, that puts a responsibility on the Ministry, which also para 10.4 appears to be putting on the regional health authorities. What do you do when you’ve reached the end of the year and you say " well who should have done what?"

A I accept that there is some potential ambiguity. However, if that ambiguity had been recognised at the time I think it would have been cleared up. I think that the key part of this funding agreement was under 10.4.

Q And to the best of your knowledge did the regional health authorities ever say to the Ministry, "well we actually think the incorporation of the government’s 1991 Policy …means the Ministry has certain obligations about laboratory services and cytology as set out in that Policy agreement which conflict with our funding agreement responsibilities?

A To the best of my knowledge that never occurred.

5.81 There was clearly confusion between the two health agencies in relation to their respective roles under the 1993 Policy. Each agency appears to have had its own interpretation of the responsibilities that the Policy and the funding agreements placed upon them, and they each appear to have been totally unaware of their different interpretations. Because of this neither said anything to the other about the confusion.

5.82 The presence of this confusion is confirmed for the Committee by the review that the Ministry of Health carried out for the Associate Minister of Health in April 1996. At the time it was considered that accountability arrangements between the Ministry and the Regional Health Authorities were contributing to problems with the Programme. Ms Glackin informed the Committee that the official’s report dated 11 April 1996 identified three key problems for the Programme. One of these was confusion between the Ministry and the Regional Health Authorities over "accountabilities for the Programme". The Ministry appears to have recognised at the time of the review that the Regional Health Authorities "saw themselves as purchasing a series of individual components which contributed to a programme owned by the Ministry rather than purchasing an integral service for women."

5.83 The practical effect of this confusion is that it seems from 1993 until the new Policy in 1996 the Ministry of Health considered that it could not carry out the responsibilities the Policy placed upon it in clause 4 and, therefore, it did not specifically attempt to do so. But the Regional Health Authorities were not stepping into the breach created by the Ministry’s inability to carry out its responsibilities because as they saw it the Policy placed the responsibility for the laboratory component of the Programme on the Ministry. The end result of this confusion was that little, if anything, was done in terms of clause 4 of the Policy.

5.84 Certainly, in response to their contractual requirements under the funding agreements with the Ministry, the Regional Health Authorities were working towards requiring all laboratories to gain accreditation for all of their services. Even then, the funding agreements only required Regional Health Authorities to exert "reasonable endeavours" to achieve accreditation. But, as Mr Mules acknowledged, this was different from the specialised accreditation that the Policy contemplated in clause 4.1.4 for laboratories reading cytology for the Programme. The funding agreements did not reflect the content of the Policy; they made no attempt to distinguish cervical cytology laboratory services from other laboratory services by requiring cervical cytology to be read only by TELARC accredited laboratories. No one was doing anything meaningful to ensure that the criteria envisaged in clause 4.1.4 were actually being developed, and once in place adhered to. There were many discussions with various advisory groups about what should be done, but ultimately nothing meaningful was done by the Ministry in relation to its role in clause 4 of the Policy.

5.85 There is another aspect to this confusion. On 24 November 1994 the Women’s Health Action group wrote to the Minister of Health regarding a woman’s false-negative smear result and asked, inter alia, what structures were in place to monitor laboratory quality and what information did the Programme have about false negative rates in laboratories used by the Programme, how were false negative rates monitored and how were they reduced in laboratories where the rate was high. The Associate Minister responded to the Women’s Health Action group on 30 March 1995 by advising them that:

"A variety of measures are in place or are being developed to ensure that the quality of smear reading is as high as possible. The 1995/96 Policy guidelines for regional health authorities state that regional health authorities must ensure that all laboratories providing cervical cytology and histology services are registered with … TELARC or an equivalent programme. The National Cervical Screening Programme anticipates that all laboratories will have TELARC (or equivalent accreditation) by the end of 1996. Several years ago the cytology advisory liaison committee made a number of recommendations to TELARC relating to performance of cytology in medical laboratories. These recommendations which were accepted by TELARC at that time, have been recently revised and upgraded and a provisional list of recommendations is currently being considered by TELARC.

As part of the TELARC registration process laboratories are required to demonstrate both internal and external quality assurance participation. While TELARC guidelines do not specify which quality assurance procedure should be followed in relation to external quality assurance the great majority of laboratories are now registered with the Royal College of Pathologists of Australasia Quality Assurance Programme in Cytology. With regard to internal quality assurance there are a number of procedures which follow…"

Further on in the letter the Associate Minister said:

"With the reconfigured National Cervical Screening Register and the comparison of histology and cytology data, New Zealand will have potentially one of the strongest national monitoring capabilities in the world. At this early stage, however, I am advised that there is insufficient data to monitor particular laboratories. I understand, however, that laboratories operate on an informal process of review where false negatives are identified.

5.86 This letter illustrates the confusion which abounded around the Programme at that time. Although the Associate Minister writes that the 1995/96 Policy Guidelines For Regional Health Authorities state that regional health authorities must ensure all laboratories providing cervical cytology are registered with TELARC, the 1995/96 Guidelines do not say that. They were issued annually and outline the Government’s priorities for health and disability services and the services to be purchased by regional health authorities. The 1994/95 Guidelines said, in relation to cervical screening, that regional health authorities:

"Are to ensure that their purchase arrangements for laboratory services for cervical cytology and histology reflect the requirement that all laboratories servicing the National Cervical Screening Programme should be registered with TELARC." (emphasis added)

The 1995/96 Guidelines (to which the Minister had referred in her letter) said:

"Regional health authorities are to ensure that their purchase arrangements for laboratory services for cervical cytology and histology reflect the following requirements that all laboratories serving the National Cervical Screening Programme :

Forwarding cervical smear test results (not accompanied by written notice of objection) to the National Cervical Screening Register in the agreed format;

Provision of timely cervical smear test results to smear takers."

Nothing else is said in the 1995/96 Guidelines about accreditation of laboratories with TELARC or any other authority. When the Associate Minister wrote in March 1995 that regional health authorities must ensure all laboratories providing cervical cytology were registered with TELARC, she was incorrect. Under the funding agreements of that time they were obliged to use no more than their reasonable endeavours to ensure laboratories were accredited. The Associate Minister had misunderstood the true effect of the Programme’s Policy documents of 1991 and 1993, the Policy Guidelines To Regional Health Authorities and the Funding Agreements in force at that time. Nowhere in any of those documents, covering the period from 1993 to 1996, was there an obligation specifying that all laboratories providing cervical cytology must be registered with TELARC or an equivalent authority.

5.87 The Associate-Minster’s response shows that the officials advising her did not realise the true effect of these documents. This is confirmed by exhibit GRB/MOH/24 at page 36 which is a Ministry action sheet. It records the officials’ advice to the Associate Minister to enable her to respond to the Women’s Health Action Group. The action sheet records that the "National Cervical Screening Programme is the first programme which has ever made registration compulsory through TELARC." This statement is plainly wrong. At the time the advice was given (sometime between November 1994 and March 1995) TELARC accreditation of laboratories reading cervical cytology for the Programme was not compulsory. This appears to have been picked up in the Associate Minister’s letter as that states that the Programme anticipates all laboratories will be TELARC accredited by the end of 1996. This statement contradicts the earlier (incorrect) statement that regional health authorities must ensure all laboratories reading cervical cytology are TELARC accredited. All of this demonstrates that neither the Associate Minister nor her officials had a clear understanding of the Programme’s requirements of laboratories reading cervical cytology.

5.88 The 26 July 1995 minutes of the Cervical Screening Liaison Advisory Committee show that the Programme’s national co-ordinator also had no clear understanding of the Programme’s requirements of laboratories. She is recorded as asking the advisory committee for "clarification on what the Programme would do if a laboratory had not improved with the insistence of TELARC". The minute records that the advisory committee "acknowledged such a situation would have to be investigated and may require further action." This minute shows that the national co-ordinator was unclear about what to do if a laboratory was not bringing itself up to accreditation standard. The reality is that as at July 1995 there was nothing that the Programme could do. The Programme had no authority over laboratories; there was no direct contractual relationship between the Minister/Ministry of Health and laboratories. At that time laboratories contracted with regional health authorities. The contracts did not require laboratories to be accredited with TELARC or any other quality control authority, therefore a laboratory did not need TELARC’s approval to perform cervical cytology. If the Programme staff became concerned about the performance of a laboratory the only legal means of addressing the problem would have been to request the regional health authority which had contracted with the laboratory, to exercise any contractual powers it may have had to suspend the laboratory. The other possibility would have been for the Minister of Health to issue a directive to the regional health authority pursuant to his or her power in s.40 of the Health and Disability Services Act. However, the exercise of a s.40 directive would have been an extreme measure. In any event the effectiveness of either an informal request or a s.40 directive would have depended on whether or not the regional health authority had the contractual power to suspend a laboratory from reading cervical cytology. What concerns the Committee is that the national co-ordinator appears not to have understood the legal position, and she did not know that the Programme could take no steps against a poorly performing laboratory. She should have known that under the new health structure the Programme’s staff had no power to take remedial action against a laboratory that was either performing poorly or failing to meet TELARC’s requirements. This is a further indication to the Committee of the lack of understanding and confusion among those working in the Programme regarding the requirements it placed on laboratories and how the Policy fitted with the Guidelines to Regional Health Authorities and the funding agreements.

5.89 The confusion surrounding the accountability arrangements and the impact this had on the delivery of the responsibilities in clause 4 of the Policy can be attributed to the poor design of the 1993 updated Policy. The design failed to ensure that the structure of the Policy and the allocation of responsibilities under that structure fitted well with the newly re-structured health sector and the accountability arrangements between the Ministry and the Regional Health Authorities (even though the 1993 Policy recorded that it had been revised and updated to accurately reflect the structural changes to the health sector). If the Ministry could not carry out its responsibilities in clause 4.1.3 these responsibilities should have been placed with an agency in the new health structure, which was well placed to carry them out.

5.90 The Policies of 1991 and 1993 were operative throughout the time that Dr Bottrill was practising at Gisborne Laboratories. The inclusion in both Policies of an intention that quality control be assured by accreditation with TELARC or another similar authority shows that the Department and the Ministry accepted the importance of accreditation and saw that it was needed.

5.91 However, both Policies had no intrinsic means of compelling accreditation. Nor were they designed around extrinsic means of compelling accreditation. Prior to 1993 the Ministry believed it was powerless to enforce accreditation. Dr Boyd told the Committee that, once the National Cervical Screening Programme was in operation, the Department had sought advice on making laboratory accreditation with TELARC or a similar authority a condition of payment under the Social Security (Laboratory Diagnostic Services) Regulations from one of its in-house solicitors. The advice the Department received was that it was doubtful as to whether the regulations permitted this. After 1993 the power the Ministry had through the funding agreements with the regional authorities was not exercised in a way which would have secured compulsory accreditation. This was implicitly accepted by Dr Lambie, the Deputy Director-General, Corporate in the Ministry of Health. Dr Lambie’s evidence was that many of the service obligations in the funding agreements between the Ministry and the regional health authorities were qualified by the words "reasonable endeavours." At the time the Ministry had three types of service obligation which it imposed on regional health authorities through the funding agreements. These were: mandatory obligations; obligations to use "best endeavours to ensure" something was done and obligations to use "reasonable endeavours to ensure" something was done. Of the three types of obligation, the obligation to use reasonable endeavours was the weakest. The end result was that the National Cervical Screening Programme was powerless to ensure that the cytology of the women, whom the Programme was designed to benefit, was competently read.

5.92 Mr Lambie also accepted that in terms of an attempt to measure the progress towards TELARC accreditation, that would be more easily achieved if there were a finite time frame in place. And that once the finite period of two years in paragraph 4.1.2 was removed from that paragraph in the 1993 updated version of the Policy, progress towards accreditation became more difficult:

"Q For example, under the 91 policy when you got to 93, if you could see that laboratories were still unaccredited at that time it would be very clear to you that the intent in the 91 policy had been completely achieved.

A Absolutely.

Q But when you move to a circumstance where there is no finite period and the move to accreditation is dependent on a reasonable period of time, it then requires a subjective decision on what is a reasonable period of time in order to be able to determine whether the move towards accreditation is proceeding slowly or quickly or somewhere in between, is that right?

A That’s right.

Q In that sense, then, in wanting to assess whether or not the move towards accreditation is happening in a manner with which you are happy, it is much more difficult to do that without a finite timeframe, isn’t it?

A I absolutely agree.

Q And it would also be more difficult to be critical of laboratories that hadn’t become accredited if you hadn’t imposed a finite timeframe by which they should be.

A Yes."

5.93 The Ministerial Review Committee of November 1989 had advised the Minister of Health that the success of a cervical screening programme turned on all aspects being developed simultaneously as each was an integral part of achieving success. Unfortunately the National Cervical Screening Programme was not planned in this way. Compulsory quality control and laboratory accreditation was seen by everyone from the Programme’s outset as important and necessary. Yet it did not become an integral part of the programme until some time after Dr Bottrill’s retirement.

5.94 Section 12.2.2 of the Policy Statement Of The Government Policy For National Cervical Screening Expert Group had recommended that all laboratories reading cervical cytology be accredited with TELARC or an equivalent authority by 1993. Section 12.2.3 had recommended that the Department of Health should be responsible for confirming that laboratories reading cervical cytology were TELARC-accredited and that without this confirmation a laboratory could not be paid. Had this entire recommendation been placed in the Government National Cervical Screening Policy 1991 it would have ensured that all laboratories were accredited by 1993.

5.95 Ms Grew, who was the National Co-ordinator during the time when the 1991 Policy was being developed, told the Committee that she had received oral legal advice that it was not possible to tag payment to laboratories in that way. However, the Department promoted legislation in 1993 to allow for an opt-off register and the recording of histology results. It seems to the Committee that if the Department believed that it did not have the legal authority to require TELARC accreditation as a condition of payment for laboratories and it considered that laboratories should be TELARC-accredited it should have promoted legislation to achieve this end. Apart from evidence that the Department was informed by its legal advisers that it had no power to make TELARC accreditation compulsory the Committee has seen no evidence of the Department taking any further steps to attempt to procure for the Minister or the appropriate departmental officer the necessary authority to permit TELARC accreditation to be made compulsory.

5.96 The Committee did not receive a satisfactory explanation for why nothing was done to ensure that the design of the 1991 Policy mandated TELARC accreditation by a specific date. The explanation the Committee received suggested that at the relevant times the national co-ordinators were overly reliant on the advisory groups and did not act to ensure that the design of the Policy and its implementation carried out the intent, which it seems everyone had, for laboratories to be accredited. Certainly, in the Committee’s view, making TELARC accreditation a condition of payment would have forced those laboratories that wanted to continue reading cervical cytology to become accredited. These issues were raised with a panel of Ministry officials who gave evidence at the final day of the public hearings :

"Q At the moment we’re talking about 1990 and there is a report that the expert group has prepared in 1990 saying that reading smear tests by laboratories payment should be tagged to TELARC accreditation. Now we haven’t seen anything set out dealing with what the Ministry’s response was at the time. What we have seen is a screening policy statement of 1991 which picks up some of what is in paras 12.2.2 to 12.2.4,but it certainly omits the requirement that the laboratory benefit payment be tagged with a TELARC accreditation requirement. Can you comment on that?

A - Ms Grew In the first six months of my job I have to say that dealing with this particular aspect of the Policy was not attainable in the first six months.

Q What about after?

A – Ms Grew Even afterwards it was not possible. I did obtain oral advice which I asked legal to put in writing in 1992, but it was consistent that I had to change the law. I considered the other requests from the expert group which were that it was extremely important to ensure that the Register was not opt-on as it was; that I should change that, and also that it was vital for histology to be linked with cytology register. Those were the two priorities …

Q To come back … to this other point about TELARC accreditation, it just goes beyond the period you were there, so anyone else can answer too. Certainly legislation was amended in 1993 with s.74A and it could have been possible, if primary legislation was needed, to amend legislation at that time to enable a regulatory requirement for laboratories reading cytology to be TELARC accredited to be put in place, couldn’t it?

A – Ms Grew It could have. I wouldn’t like to underestimate the huge task involved in simply getting the consultation around the opt-off register and also getting laboratories to agree to use the Bethesda coding system to enable the same reporting and to also get the laboratories to agree to send the opt-on women’s cytology results to the registers around the country. That in itself was a big task for the laboratories to adjust to, and I would suggest to you that getting agreement to be TELARC accredited on top of all of that, which I’m sure you’ve heard in evidence, is expensive, would have been a huge ask for the laboratories and the consultation itself would have been quite significant.

Q Are you saying that you were concerned that the laboratories would refuse to do cytology work if a regulation had been passed requiring TELARC accreditation?

A – Ms Grew No I’m not saying that. I’m saying that we required a great deal of co-operation from the laboratories and they were very co-operative in terms of all agreeing to use the Bethesda coding system, or agreeing to send cytology smear results on disk to the registers. I also have to say that Clint Teague consistently assured me that the laboratories were all moving towards TELARC accreditation. I did raise it as a concern, and it’s minuted further down the track in the Cervical Screening Advisory Committee minutes.

Q But it’s clear that as at 1993 when the screening Policy was redone to accommodate the Ministry rather than the Department of Health, the requirement in 4.1.2 of the Policy that TELARC accreditation be achieved by 1993 because the 1991 Policy said within two years had not occurred, and the Ministry’s response at that time was to leave the matter on the basis that TELARC accreditation would be achieved within a reasonable period. Why did the Ministry chose to do that when it wrote the 1993 Policy?

A – Ms Dahl I’ll answer that question. The 1993 update of the 91 Policy occurred in my time. I started in January and we started to update that soon after. The reason for updating that was to reflect the health reforms, to reflect the changes in the health structure. We did not review the Policy, we updated the Policy. The removal of the two year clause, I can’t exactly remember how it occurred, but it was not to make it more lukewarm or to reduce its impact. It was based on advice that laboratories were working towards TELARC accreditation. Many of them were already there, and we didn’t need to put something in there that said two years, there were other ways to make that occur. Meanwhile, we had also started to review with the Cytology Advisory Liaison Committee the TELARC criteria for accreditation, and there was no expectation at the time that that was going to take as long as it took. There was an expectation that that would have been finished within several months.

Q At the time, TELARC was accrediting laboratories wasn’t it?

A – Ms Dahl Yes it was.

Q It had its own standards which it used for the purposes of accrediting medical laboratories, didn’t it?

A It did. We did have some meetings with TELARC in the early parts of 1993 to discuss what they were accrediting against, and the adequacy of those criteria, and there was agreement with the CALC Committee that they needed to be reviewed, that in the meanwhile there were criteria but they did require review.

Q My understanding was that there are medical laboratories that are accredited, and then you accredit different departments differently. You can be accredited for one department and not another, and that when it came to cytology, it was really there was a need to look at whether there ought to be other criteria over and above what was already in existence. Is that right?

A – Ms Dahl That’s correct.

Q And my understanding is that the Policy itself as a result of the expert group’s meeting had determined some criteria which it thought should be in the TELARC accreditation, which would include standards set such as how many minimum smears per year were read, employment of adequate numbers of suitably qualified staff, maximum workload for each cytoscreener, adequate in-service education, satisfactory participation in internal / external quality assurance procedures and co-operation in providing cytology reports to the cytology register. Now they were criteria that the Department of Health under the 91 Policy and the Ministry of Health under the 93 Policy saw as being important for the purposes of the Programme, and those criteria could be imposed either through TELARC accreditation or some other means really if the Ministry had wanted to ensure that the criteria was in place. Isn’t that right?

A I would have been unsure what other means there would have been. My advice came from the CALC committee, I was not a technical expert on laboratories, and my understanding from that Committee was that laboratories were moving towards accreditation, everything was okay and that they would work on reviewing the criteria for the TELARC accreditation and that was the advice that I worked on in the period that I was there.

Q Another possibility would have been for the Ministry as part of the Programme to have drawn up its own standards and to have said that those laboratories that wanted to do cytology screening for the Programme must adhere to those standards.

A – Ms Dahl That’s correct ma’am, and in many instances that type of process occurs in various Government departments and it’s a very appropriate process. At the time that we’re talking about that was not the process that was working within the Department of Health, Ministry of Health. We were very reliant on expert groups and they were the groups that were advising us and we were following through on that process. Hindsight may prove that may not have been the best way.

5.97 Had the Programme been able to ensure that all laboratories reading cytology were accredited that would have stopped the cytology practices that were carried out at Gisborne Laboratories between 1990 to March 1996. The Committee has already said that it considers that these practices are likely to have led to unacceptable under-reporting. Had they been prevented then the under-reporting would have been avoided. In the Committee’s view a programme with a well-designed policy that was well implemented would have had in place measures to ensure laboratories practised quality control and were accredited. And the persons responsible for the Programme would have applied these measures if a laboratory failed to comply. For this reason the Committee considers that the poor design and implementation of the Programme’s policy in relation to laboratories is a factor that is likely to have led to the unacceptable reporting in the Gisborne region.

Failure To Ensure The National Cervical Screening Register Functioned Optimally

5.98 During the time Dr Bottrill was in practice the National Cervical Screening Register had two major flaws:

(i) When the National Cervical Screening Programme began instead of a central register there were 14 stand-alone registers, each of which was located in an area health board region. The 14 registers were unable to correlate a patient’s histology results with her cytology results. Nor were the registers able to inter-link with each other in relation to a patient’s cytology results;

(ii) The registers were initially "opt-on" registers. This meant that women had to request that their cytology results be recorded on the registers. Many were either not given the choice or opted not to have their results registered. The number of women whose results were recorded on the registers was not sufficient to enable statistically meaningful information to be derived from the registers.

The Committee will address each of these flaws below.

No Centralised Register Capable Of Correlating Histology With Cytology

5.99 A centralised cytology register which linked histology with cytology results was considered, by all the authorities on cervical screening to which the Committee was referred, to be pivotal to a successful screening programme and an essential management tool for proper quality control. The National Cervical Screening Programme did not have such a register until 1997.

5.100 It appears that the original plan for the Programme’s register was to have a nationally computerised register which was to be managed locally by area health boards. This is recorded in The Report of the Ministerial Review Committee of November 1989. This design is consistent with the recommendation made in the Cartwright Report for a centralised register based on a "regionalised" network. The Review Committee reported its support for the view that a population-based programme required a national computer based register. The Review Committee said that it was essential to extend the cytology register to include histology information so as to enable cytology and histology results for women to be correlated. The purpose of this recommendation was to allow an assessment of the overall effectiveness of the Programme to be conducted, and to provide a means of assessing the quality and uniformity of smear reading across the country.

5.101 On 30 May 1990 the National Cervical Screening Programme Expert Group reported to the Minister. The report recommended the establishment of three nationally based and inter-linked registers. A national cytology register with the cervical smear test results of individually identified women; a population register which would eventually contain the names of all women in the population; and a histology register which contained the results of biopsies to determine the rates of pre-cancerous abnormalities and cervical cancer. The Expert Group said that each of the three registers was integral to the Programme and that the failure of any one of them would jeopardise the Programme. Subsequently in August 1990 the Expert Group produced the Policy Statement Of The National Cervical Screening Programme Expert Group. In this document the Expert Group said that:

" …the expansion of the cytology registers to include relevant histology was an urgent priority, not only to ensure that women with abnormal smears are being properly followed up but also to evaluate the quality of smear reading in laboratories." (emphasis added)

5.102 Judith Straton in her review of the Programme in 1990 emphasised the importance of a register which linked cytology with histology results:

" …the provision of histology to the Register is essential for the correlation of cytology and histology reports, which provide an important measure of the quality of the screening."(emphasis added)

5.103 It appears from reading the Straton Report that Judith Straton was also aware of the decision to locate a cervical screening register with each area health board. Like the Ministerial Review Committee she too favoured having the registers in each area health board linked to a central register. Also in 1990, the National Cervical Screening Programme Expert Group recommended that the Programme be linked to the Cancer Registry to provide correlation of smear reading results with proven cancer, even though the histology specimen may have been reported by another laboratory at a later date.

5.104 The Cancer Screening 1991 Cervical Screening Recommendations A Working Group Report described a national register as: "the essential management tool to allow a proper valuation of all the components of the screening process". It also said that a register should, "include relevant histology results to allow co-relation and evaluation of cytology findings."

5.105 The World Health Cervical Cancer Screening Programme Managerial Guidelines, issued in 1992, recommended:

"…an efficient monitoring requires a system of linked records. A population register (or available substitute) allows periodic call back for re-screening at appropriate intervals. The cytology register when linked with a cancer register (which should be ad hoc and specific to cervical cancer) permits women with cytological abnormalities to be recalled for repeat screening diagnosis and therapy. Evaluation of the programme can then be carried out with regard to the assessment of :

Management of women with positive smears;

False negative smears;

Cancers which are detected during the interval between consecutive screens;

Groups missed in the target population.

5.106 The benefits of correlating histology with cytology results were confirmed for the Committee by Dr Boyd. He told the Committee that correlation of histology and cytology results can be considered as an external and internal quality assurance activity. He said that as an external check on a laboratory’s performance the Register can provide statistics to show the proportion of women having colposcopy whose histology results confirm the result of a previous smear reading; and those whose histology results do not confirm previous smear readings. Either way the histology results provide helpful information when it comes to assessing laboratory performance in smear reading. If the histology results confirm the cytology results, that confirms the laboratory’s accuracy in reading smear tests. If the histology results do not confirm the cytology results that would mean either the cytology results were false or the biopsy did not sample the lesion detected by the cytology. It could also be due to the misreading/misreporting of the histology. The proportion of false positives and false negatives that a laboratory produces can indicate whether or not the laboratory’s performance is acceptable, and consequently whether or not unacceptable under-reporting is occurring.

5.107 Dr Boyd described the Register’s usefulness as an internal quality control to the Committee in the following way:

" … the correlating of cervical cytology reports generated within the laboratory with the histology reports obtained following colposcopy and the reports of cancer incidence from the cancer registry provides an opportunity to re-examine the previous slides with a higher index of suspicion. The laboratories develop their own protocols for this look-back. The look back should not be restricted to the most recent slide. In one laboratory I visited an arbitrary figure of five years has been selected, so that all previous slides for that woman over that period are re-examined."

Professor Skegg described the correlation of cytology results with histology results as being of "fundamental importance" and he said it was "inexcusable that so many years elapsed before it was done".

5.108 During the early stages of the Programme’s development, all the advice to the Minister and the Department of Health from the various advisory groups, consultants and the available overseas literature favoured a centralised register which linked histology with cytology results. The only variation in this advice was between the view that there should be one national register or alternatively a series of regional registers which inter-linked with a central computer. Nevertheless, when the National Cervical Screening Programme began it was not designed around a centralised register. Instead there were 14 stand-alone registers each associated with an area health board. There was no linkage between these registers, and since the histology results were not recorded, the registers did not allow histology results to be correlated with cytology results. This arrangement caused problems and prevented the Register from functioning optimally. One of these problems was that the usual capability of a screening register as a tool for quality assurance was seriously compromised. The Register could not be used as a source of information to show if there was unacceptable under-reporting of smear test results.

5.109 The 14 stand-alone registers were installed in all 14 area health board regions between December 1990 and September 1991, and they were all fully operational by early 1992. The Department of Health supplied each area health board with the same software and hardware, however, the computer systems were not linked electronically. This meant that all transfers of information between local sites were done by paper. This state of affairs continued until the registers were finally reconfigured into a central register, which was completed in 1997.

5.110 Ms Glackin told the Committee that not having a centralised system: "Did create a problem and was very time consuming when women moved to a different region." She said that the fourteen separate registers led to difficulties with tracking women who moved, and that this compromised the Register’s recall functions. The Registers could not verify personal data electronically between them. Women who may have been enrolled in one region re-enrolled in another region. This led to duplication in enrolments. Until the 14 stand-alone registers were combined, each register could only give the smear histories of women who were enrolled in the region where that register was located. Only since 1997 has data for the whole of New Zealand been accessible from any regional co-ordination site. The software programme for the 14 registers did not allow histology to be linked with cytology. But, even if the software had allowed it, because there was no centralised system which could track women when they moved to other area health board regions the histology results still could not have been effectively linked with the cytology results.

5.111 The Committee learnt from Ms Sandra Matcham, who is the National Register Co-ordinator for the Programme, that once the 14 registers got underway, there were difficulties with some regional sites. She said that 11 of the smaller regional sites had sufficient capacity for their processing requirements, but that the Wellington and Canterbury sites began to show signs that their systems could not cope with the volume of work and by 1994 the Auckland site had reached the point where processing the information had become difficult for the staff, and they were progressively getting behind with the work. This pressure helped to delay the progress of the re-configuration of the registers. It is also another example of the difficulty created by having 14 stand-alone registers.

5.112 The Committee heard from Ms Gillian Grew who was the first National Co-ordinator of the National Cervical Screening Programme from June 1990 to July 1992, and from Ms Susan Dahl, who was the National Co-ordinator from January 1993 to September 1994 about the difficulties the 14 registers caused them. Ms Grew told the Committee that not having a single database was one of the difficulties the Department encountered when it came to prepare the first statistical report for the Programme. Ms Dahl, who was the co-ordinator at the time the second statistical report was prepared said that it was :

"Very difficult to do the second statistical report and that related to the fact that we did have 14 registers at the time.".

5.113 She told the Committee that the Ministry had to create programmes to get the information downloaded from the 14 sites and then compile the information in Wellington. She said that once the Register was reconfigured the Ministry believed that data would be more readily available, and therefore it would be easier to prepare statistical reports. Since its inception the Programme has prepared only three general statistical reports and one statistical report on for Maori women. The Committee also learnt from Ms Grew that quite early on in the Programme area health boards began to tinker with the registers’ software programmes, and this had the effect of "confounding" the national statistics. Ms Grew’s comments on the impact of the 14 standalone registers on the Programme were :

‘In the first place I couldn’t see why New Zealand needed 14 registers and it became very apparent that that was highly undesirable given, you know, the fact that women moved around the country. Although there were arrangements for electronic transfer on disk it seemed incredibly inefficient to do it that way, and I do think that having 14 different sites dealing with the software there were high risks, and I know from the register people now that they had to clean up the data considerably when they reconfigured into one register."

The Committee also learnt from Ms Grew that until the Register became an opt-off Register which was capable of correlating histology results with cytology results she was unable to quantitatively monitor the quality of laboratory performance. She said that was why she worked to get "opt-off" registers which recorded and correlated histology with cytology.

5.114 The first support the Committee was able to find in the evidence for regionally based registers was in a report dated 21 November 1988 by Azimuth Systems Limited for the Department of Health. The Committee understands that Azimuth Systems Limited was a computer consulting company. The report was titled Proposal for a National Co-ordinated New Zealand Cervical Screening Programme. The Azimuth report referred to the planned establishment of area health boards and recorded that as a result the Department of Health would no longer be directly involved in the delivery of healthcare through its regional health development units. It then reviewed implementation options for a screening programme. These were: a single national system with remote access provided for each area health board or a separate system in each area health board region with linkages through a national master patient index. It described the national system as having all data and processing carried out using a single facility with each area health board having remote terminals and printers. Data was to be partitioned so that each area health board only had access to and control of its own data. The advantages of this system were said to be: simplification of day to day operations, provision of a uniform system throughout the country, simplification of data transfers on women who move between areas, simplification of the interface to a national patient index. The disadvantages of a single national system were said to be a need for extensive co-ordination between area health boards, providers and "the national level", separation of both physical and control aspects of the computer system from the cervical screening programme users and the impact on strategic data processing options and initiatives of individual boards since it would require them to use equipment and facilities which may not be suitable to them. The Azimuth report then described the second option of having separate systems for each area health board. This option was said to require a means of accessing a national patient index to maintain name and address information and to identify women who have not yet had cervical smears. The report also noted that a regionally based system must allow for information to be exchanged with other regional systems when women move between areas. The advantages of this option were described as: having a minimal impact on area health boards’ autonomy in selecting hardware and software for local information processing, providing area health board centres with autonomous control over the operation of their service, allowing integration with other systems operated by area health boards, being more responsive to local needs without impacting on the national screening programme. The disadvantages were described as being: the need for a national co-ordinating function to set the minimum requirements and the protocols for information exchange and to monitor the national register. Secondly, full implementation of the national programme was dependent on the slowest implementation by an area health board. After having reviewed these two options the report concluded by recommending a separate registration system for each area health board. The reason for preferring this option was said to be the present policy intent to decentralise health care management:

" Given the present strategic direction of decentralising health care management responsibility to area health boards then a separate system for each AHB [area health board] Centre is proposed. Each AHB Centre will have access to a nationally maintained patient index and an investigation of the existing National Master Patient Index system should be undertaken to determine if it is suitable for this role."

There is no reference in the Azimuth Report to any authoritative literature on screening programmes that would support the establishment of 14 separate registers. The recommendation appears to emanate from policy considerations arising from the decentralisation of health services rather than to have been driven by sound principles relating to the organisation of screening programmes.

5.115 Another reason supporting regionally based registers appears in Judith Straton’s Report. She describes the presence of a widespread suspicion about the Register among women and health professionals. She says that this suspicion was partly related to the perception that the Register was primarily based in Wellington. She says the suspicion may have lessened if the registers were promoted as regional area health board registers with only non-identifying data going to Wellington. She also said that the notion of the register for national audit had been over-emphasised and that the register "needed to be brought down to the level of the individual woman with an indication of what the benefits are to her." She continued in this vein by stating that:

" Giving women too many details about the workings of the Register, while laudable, is quite likely to be counter-productive, as women may be intimidated by it. This applies particularly to women who are most at risk, who tend to be older and less well educated, and may have good reason to be suspicious of government bureaucracy."

The Committee considers that if reasons such as these influenced the Minister of Health in the choice of stand-alone registers it is a matter of regret. There was good reason for either a regionally based but inter-linked centralised register or for one register to hold all the information. There is no good reason to support having 14 stand-alone registers which were incapable of sharing information. All such registers could do was to record a woman’s smear tests during the time she resided in a register’s locality and act as reminders to her when the time had come for another smear. They could not reliably be used as a quality assurance tool to allow monitoring and auditing of the programme, (and included within that is laboratory performance), or as a source of epidemiological information to help reduce the incidence of cervical cancer because there could never be any certainty that the information recorded on a register about a woman gave a complete record of her cervical history. In the Committee’s view it would be a very short-sighted woman who did not appreciate the benefits to herself of these wider measures. It is of concern to the Committee that in 1990 an assumed timidity and ignorance on the part of women could be given as a reason not to inform them fully about the Programme.

5.116 A further reason for regional registers appeared in the evidence of Ms Sandra Coney. She informed the Committee that in the beginning in some regional areas people were concerned about information going outside their region and they felt they would have more control over it if it were recorded on a register based in their region. This is similar to the view expressed in the Straton Report. However, it is not a view which justifies running 14 stand-alone registers. The inefficiencies, which result from this structure, clearly outweigh any concerns about misuse of information. These concerns could have been accommodated in other ways. Furthermore it is difficult to see what is to be gained in storing information regionally; that in itself does not guarantee the protection of the information’s confidentiality. The type of protections that do keep information confidential can work just as well on a national basis as they can on a regional basis.

5.117 Against these reasons are the sound epidemiological reasons for having a central register which recorded the smear histories of women throughout the country and which allowed cytology results to be correlated with histology results. The Ministerial Review Report of 1989 emphasised the importance of ensuring that the links required to build the regional system developed by Azimuth into a national system needed to be put in place. The Expert Group’s report to the Minister on 30 May 1990 emphasised the need for a national based cytology register. The Policy Statement Of The National Cervical Screening Programme Expert Group dated August 1990 recommended a regional system of cytology registers which were linked to a central register.

5.118 Ms Glackin told the Committee that a decision was made early in the development of the Programme that there would be 14 stand-alone register sites. Even though the Azimuth Report had supported having separate regional registers it is difficult to see why this advice was followed. The limitations of 14 stand-alone registers should have been obvious from the outset. The Straton Report had at least favoured registers in each area health board region which were linked to a central register.

5.119 Ms  Matcham told the Committee that it would have been technically possible to have net-worked the regional computer data bases to a central site between 1990 and 1991, as a register was set up in each area health board’s region, but at significant cost. She said that a much larger central computer would have been necessary and that telecommunication lines 10 years ago were more expensive than they are today.

5.120 No-one from the Ministry gave the Committee an explanation as to why, from the outset, a single computer located in one site could not have been used to hold the cytology results for all women whose results were being recorded. The relevant female population for screening in New Zealand is not large. It could easily all have been accommodated on one centralised register. The expense Ms Matcham spoke of was for the type of system now in place where the 14 regional computer sites are networked to a central site. While this may have been expensive in the early nineteen nineties it does not follow that at the outset a single computer based in one locality would have been more expensive than the system of 14 separate computers which was adopted. If a centralised system of regionally inter-linked computers was too expensive, a single computer with systems in place to ensure that laboratories throughout the country forwarded their results to the computer could have worked. Although a larger computer would have been needed, it would be surprising if the cost of one computer to hold all the information would have been more costly than a centralised system of regionally inter-linked computers. It may also have been less costly, once all the duplication and consequential inefficiencies were taken into account, than the 14 stand-alone computers of a smaller size. The Committee has learnt that the laboratories forward information on floppy disk to the regional co-ordination site. The information is then read into the database and validated. Rather than laboratories sending information by floppy disk to regional co-ordination sites, it is difficult to see why from the outset they could not have sent the information to a single computer. For those laboratories unable to send the information electronically, they could have sent it in paper form.

5.121 With the change to a decentralised health system which used area health boards to deliver health services, the Minister may have considered that a centralised system of inter-linked regional registers was too expensive at that time and that a single nationally-based register, for which the Department was responsible, was at variance with the move towards a more regionally based health system. While the concern for expense and the desire to adhere consistently to an adopted philosophy for health delivery is understandable, it should not have been allowed to affect detrimentally the design and implementation of the National Cervical Screening Programme. The design of the Register was fundamental to the success of the Programme. Professor Skegg had written of this in his article in the New Zealand Medical Journal of October 1989 titled How Not To Organise A Screening Programme. He wrote:

"Schemes based on inadequate registers are doomed to fail."

Although Professor Skegg was writing primarily about the decision to have opt-on registers, it is clear to the Committee that he did not support regionally based separate registers as he referred with approval to the notion of a comprehensive population based register. The Committee considers that Professor Skegg’s comment on the impact of inadequate registers on screening programmes can be read as being of general application to any material inadequacy. When his comments are read with the comments from the Ministerial Review Committee and the Expert Group supporting a national cytology register this should have signalled a warning against having 14 stand-alone registers.

5.122 There was sufficient authoritative material at that time about the importance of a well-designed register. None of the authoritative material the Committee has seen recommends having a discrete series of registers that cannot communicate with each other. Nor was the Ministry able to point the Committee to any material that would support the idea of having fourteen stand-alone registers in a country the size of New Zealand. Whatever may have prompted the setting up of 14 stand-alone registers, there is nothing in any material that the Committee has seen to suggest that it was a sound way to set up a cervical screening programme’s register. If the decision to have 14 stand-alone registers was influenced by a concern to ensure that the register fitted in with the new decentralised heath structure it is most unfortunate. The effectiveness of the register should not have been compromised by considerations of that kind.

5.123 By February 1993 the Minister and the Ministry of Health had accepted that the 14 standalone registers needed to be inter-linked nationally. In February 1993 the Associate Minister approved the release of a discussion paper dealing with future reconfiguration of the Registers. By April 1993 consultation over the options for reconfiguration was completed with the majority support being for a national register with remote access. Final approval for the reconfiguration was given on 12 January 1994. Final approval to start tenders to allow the reconfiguration to be implemented was given in late 1995. The reconfiguration started in May 1996 and was completed in February 1997. Since 1997 there has been one centralised stand-alone database with regional access from 14 sites.

5.124 Although the need to link histology with cytology was recognised relatively early on in the Programme’s implementation this was not achieved until late 1996. Without a national register, which linked histology with cytology, it was impossible to gain sufficient information to evaluate laboratory performance. The benefit of correlating histology and cytology results can be seen from what happens now. At present a laboratory can request from the Register reports which give details of the histology reports for all women for whom the laboratory in question has read cytology results in the previous five years. Where there has been a negative smear reported within five years prior to a high-grade histology result, that information is highlighted automatically by the Register when generating the report. Thus the type of information which can immediately bring to a laboratory’s attention a suspect cervical history is readily accessible. This allows a laboratory to check whether or not earlier negative smear results are correct or result from under-reporting. This type of "look back" investigation using the Register has two benefits : it can assist laboratories to discover errors in their reporting; and it can be used by Programme staff to detect laboratory errors. It has only been available since February 1998.

5.125 If, from the outset, the Register had been configured as a single national register with correlated histology results with cytology results, an effective tool to monitor laboratory performance would have been available to pick up Dr Bottrill’s under-reporting. Once one of his patient’s had a biopsy with positive results the computer could have generated a report showing the patient’s cervical smear history. Certainly before any use could be made of this information someone would have to request it. However, if Dr Bottrill had known this information was readily available he may have done so. Equally, the Programme could have employed someone to request routinely the smear histories for women with positive histology with a view to checking the results of their earlier smear tests as part of a regular monitoring exercise.

5.126 The Committee has already concluded that the failure at Gisborne Laboratories to have an organised programme which correlated a patient’s cytology results with her histology results and which looked back on her previous smear history was a factor in the unacceptable under-reporting at that laboratory. The Committee considered that had Gisborne Laboratories carried out this procedure it may have alerted Dr Bottrill to his very low false positive rate and so caused him to realise that he was being overly critical and " setting the bar too high" when reading smear tests. This in turn should have alerted him to the probability that he was under-reporting too many smear tests.

5.127 A centralised screening register, which was designed to correlate a patient’s cytology results with her histology results, would have been an effective substitute for, if not an improvement on, a laboratory organised programme to correlate cytology with histology. If the National Cervical Screening Register had been in this form during the time Dr Bottrill was in practice it would have been a source of information to alert him to signs that he was under-reporting smear tests. For this reason the Committee considers that the inability of the Register to provide Gisborne Laboratories with access to this information during the time that Dr Bottrill was in practice is a factor that is likely to have led to unacceptable under-reporting.

"Opt-on" Registers

5.128 When the Programme began it was based on an opt-on register. Women had to actively exercise a choice to go onto the Register. The result was that enrolment was not as high as the Department would have liked, and the Register was insufficient to be able to derive any statistically meaningful information. Studies in New Zealand and overseas showed that an opt-on register was likely to recruit only 30-40% of women having a smear, and that with such low enrolments there was risk that there would be too few women enrolled on the Register for the Programme to meet its objectives of increasing coverage and reducing mortality and the incidence of cervical cancer.

5.129 In October 1989 Professor Skegg published an article in the New Zealand Medical Journal titled How Not To Organise A Screening Programme. In this article Professor Skegg was very critical of the use of opt-on registers. He wrote:

"There is abundant evidence from other countries that it is possible to spend vast sums on cervical screening without achieving much. We cannot afford to repeat their mistakes. Despite the lack of details one aspect of the New Zealand scheme sounds particularly ominous. Considerable emphasis is being placed on computer- based registers which will be restricted to women who have indicated that they wish to be part of the programme. Apparently no information will be put on these registers without the signing of written consent forms on every occasion.

The full potential of cervical screening can only be realised with effective systems to invite all women for screening, and to check that appropriate action has been taken on positive results. Computer-based schemes appear to offer the best opportunities and the main characteristics of successful programmes are that they consumer oriented but service initiated Schemes based on inadequate registers are doomed to fail."

5.130 In May 1990 the National Cervical Screening Programme Expert Group recorded in its report to the Minister its support of Professor Skegg’s article. It went on to recommend that the Programme should be designed to allow automatic participation in the Programme with the ability to opt out, and that legislation to enable this to occur should be passed. The opt-off option was supported because it was considered it would encourage greater participation in the Programme, provide greater choice, provide greater ability to assure quality, result in less data fragmentation, and allow the identification of targeting requirements to provide a better basis for policy development. It is difficult to see why the initial opt-on registers ever found favour.

5.131 In November 1991 the Associate-Minister of Health endorsed a requirement for legislation to bring about an opt-off register for the Programme. This required an amendment to the Health Act 1956; the amendment was passed in 1993. Once the Register became an "opt-off" register there was a dramatic increase in enrolments, and therefore data. Overnight, 80-99% of all smear results from various laboratories were being forwarded to the Register (as opposed to 20-40% prior to the introduction of the legislation). Enrolments rose to 55% of eligible women in 1994, 69% in 1995 and 81% by 1996. The Committee was told that by the end of the calendar year in 1999, enrolments on the Register had risen to 91% with 84.6% having had a smear in the previous 5 years. This exceeded the projected target set in the 1996 Policy and compared well with cervical screening programmes internationally. However, the use of an "opt-off" register only became possible by 1993 and then it was caught up with the need to reconfigure the register into a national register. The impact of this was that it was not until after Dr Bottrill retired that the Programme was able to generate information from the register that gave any reliable indication of a laboratory’s diagnostic performance.

5.132 The Programme began with a register system that was sub-optimal. The system did not become fully effective until 1997 when it was reconfigured into a national centralised register. Although it was recognised early in the Programme that the system of 14 stand-alone registers was not operating effectively, and that this in turn was having a detrimental impact on other facets of the Programme, it took until 1997 to reconfigure the registration system into an optimal form. The system’s two major flaws were features which were contrary to all the expert advice that was available during the time the Programme was being set up. The Committee considers that the detrimental impact the sub-optimal registration system had on the Programme is perhaps best explained in this interchange between the Committee and Ms Grew.

"Q When you look back now it seems that all the work, however well intentioned it was from the outset up until 1993, has turned out to be misplaced in the sense that all the work that went into setting up 14 different registers, being opt-on registers, then had to be redone with the national Register in circumstances where it was opt-off, which was one of the early recommendations coming through from the expert group.

A All I can say … is that there were some givens. My job was to set up the Programme within the constraints already in place and that is that there were 14 registers. I did get policy approval to look at rationalising those down to one, so it was clear even in the very early days that we were asked to set up something that was not ideal at the end of the day, and my first job really was to set up something and then obtain approval to change it so that it was more effective." (emphasis added)

With a sub-optimal registration system the Programme was never going to operate effectively; in particular the registration system could not be used to monitor the performance of laboratories and so it could not be used to detect under-reporting. Professor Skegg told the Committee that he found it " extraordinary [that] we have spent millions of dollars each year establishing and maintaining these registers [the National Cervical Screening Register and the Cancer Register] but we are not using them in they way they could be used to advance the health of women." In the Committee’s view the sub-optimal character of the National Cervical Screening Register and the impact it had on the effectiveness of the Programme is a factor that is likely to have led to the unacceptable under-reporting that occurred in Gisborne.

Failure To Put In Place Laboratory Performance Standards And To Make Reliable Data Available

5.133 Throughout the time that Dr Bottrill was in practice at Gisborne Laboratories the National Cervical Screening Programme had no laboratory performance standards in place and it had no reliable data. Therefore, it was not possible to monitor and evaluate laboratories’ performance. Without doing this it was not possible for those responsible for the Programme to detect incidences of unacceptable under-reporting.

No Laboratory Performance Standards

5.134 There was no dispute from any of the witnesses heard by the Committee that performance is more easily measurable if standards are in place. By performance "standards" the Committee means quantitative benchmarks which a laboratory must achieve as opposed to something which a laboratory should aspire to achieving. Performance standards are a measure against which those monitoring performance assess whether or not a laboratory is performing according to expectations. Performance standards specify the expectations of a health service. Without performance standards it is not possible to monitor adequately, if at all. The importance of this has always been well recognised. From the evidence the Committee heard there appeared to be no dispute that monitoring, if it is to be done properly, requires the imposition of performance standards. Professor McGoogan told the Committee that it was very difficult to evaluate data without pre-set standards. In addition, it was difficult to measure quality of performance without pre-set standards. In Professor McGoogan’s opinion, the absence of standards did not reflect well on the New Zealand Programme:

"Q Could you offer an opinion on the New Zealand approach to creating the national average and how that would impact on one’s evaluation of laboratory practise relative to the national average?

A I’ve said before in evidence that the measurement of quality is the degree to which one conforms to pre-set standards. The three statistical reports provide interesting data about what is happening to women in New Zealand who are registered with the screening Programme, but it is very difficult to evaluate this data without a standard against which to compare it. It seems to me these standards have never been set.

Q Well it appears that a standard may have been set for laboratory reporting by pooling the results of all laboratories and creating an average.

A The principle is an average if New Zealand wishes to set its standard as the average of all the laboratories. It number one should say so and number two it should justify it. When one makes an average you take a wide range of laboratories whose practice may differ enormously, and averages notoriously hide excellent practice and very poor practice within them. That was the specific thing we wished to avoid in the UK in setting the standard in 95.

Q What does it tell you about the New Zealand Programme if there were no standards set?

A Unfortunately it does not reflect well on the New Zealand Programme. There seems to be a belief that simply doing the work is good enough, not necessarily doing it to a high standard or at least an acceptable standard … Again I’m very impressed with the effectiveness of the New Zealand Cervical Screening Programme. You have reduced the incidence of cervical cancer in both your Maori population and in the rest of your population, so your screening Programme is effective, but without quality standards in place you cannot evaluate how much more effective it might have been.

5.135 In New Zealand the importance of having performance standards for laboratories reading cervical cytology was recognised as early as 1989. Section 8.13 of the Report Of The Ministerial Review Committee On Implementation Of A Government Policy for National Cervical Screening, which was published in November 1989, recommended the development of a set of minimum standards of competency for laboratories and smear readers. An example of overseas authority supporting the need for performance standards is the European Guidelines for Quality Assurance In Cervical Cancer Screening published in 1993:

"A pre-condition of quality assurance is the establishment of standards. The aim of the quality assurance programme is to ensure that these standards are met."

5.136 A departure from the view that performance standards are essential for a programme can be seen from the minutes of the Cervical Screening Liaison Advisory Committee on 26 July 1995. At the meeting there was discussion about analysis of laboratory statistics which were contained in a draft report of the Programme’s performance (the Second Statistical Report). Copies of laboratory statistics had been taken from the draft report and circulated to the members of this committee. Those who were present at the meeting on 26 July 1995 are recorded in the minutes as agreeing to each laboratory being supplied with its individual statistics for comparison with national ranges and averages produced in the draft Second Statistical Report. This committee thought it was too early to set performance standards as it considered that appropriate statistical ranges were yet to be established The minutes recorded that:

"One of the problems with assessing laboratory performance is that the appropriate statistical ranges for cytology screening have not yet been established. Cytology is a very subjective science and it is difficult to set numerical standards. There is a danger that any standard set would be so wide that they are hardly worth setting.’

5.137 However, the Committee considers that this was insufficient reason to delay the setting of performance standards as these are not dependent on knowing the statistical range of laboratory reporting. The use of national averages to measure individual laboratory performance was criticised by Professor McGoogan. She pointed out to the Committee that the difficulty with taking a national average is that over a wide range of laboratories practice may differ enormously, and averages can hide excellent practice and poor practice within them. She said that was the very reason why in the United Kingdom they chose to set a performance standard instead. The Committee can see the wisdom of the United Kingdom approach. It seems, however, that the Cervical Screening Liaison Advisory Committee was not as alert as Professor McGoogan was to the masking effect of using a national average to provide a measure of comparison for a particular laboratory.

5.138 The Committee has heard other evidence about the importance of performance standards. The Committee rejects the view expressed by the Cervical Screening Liaison Advisory Committee. It considers that as at 1995 there was sufficient authoritative material from overseas to provide a guideline for setting appropriate numerical standards. It was unnecessary for any numerical standards that were set to reflect the performance of New Zealand laboratories; that approach belies the whole basis of having performance standards. Appropriate standards should be set according to objective measures of good performance and laboratories should be required to meet those standards. It is not a matter of discovering how laboratories are performing and then tailoring standards to reflect the average performance. Furthermore, to use the national average rate for reporting abnormalities as a standard is dependent on the assumption that the national average rate is in itself an appropriate benchmark. For example, if all New Zealand laboratories had been under-reporting to a greater or lesser degree, then the national average would in itself be a poor performance standard and to attain it would be falsely reassuring. New Zealand laboratories should have been required to ensure that their performance met numerical standards similar to those in place for cervical screening in overseas programmes. There is no reason why a New Zealand cervical screening programme should adopt lower performance standards for laboratories than programmes in other countries. New Zealand could have done the same as the United Kingdom. In addition, the view of the Cervical Screening Advisory Committee overlooks the importance of pre-set standards for monitoring and evaluation. If the Advisory Committee thought the subjective character of cytology made it too difficult to set numerical standards, it is hard to imagine how the Committee contemplated the Programme could be monitored and evaluated. The Advisory Committee’s comments demonstrate to the Committee how unaware the Advisory Committee must have been to what thorough monitoring and evaluation of the Programme entailed. It is clear to the Committee that Professor McGoogan saw no value in the New Zealand approach:

"Q You had the opportunity to look at the three statistical reports produced by the New Zealand Programme, and I am sure you have noted the laboratory reporting rates in the table. From those tables you can see that the New Zealand average for reporting rates of various pap smear abnormalities have been determined by including all laboratories that are reporting and then determining the average and the minimum and the maximum.

A Yes.

Q Now this contrasts with the approach that the UK took, which was to take the practice of 12 quality laboratories and to use their results to establish their benchmark. Is that correct?

A That is correct.

Q Could you offer an opinion on the New Zealand approach to creating the national average and how that would impact one’s evaluation of laboratory practise relative to the national average?

A I’ve said before in evidence that the measurement of quality is the degree to which one conforms to pre-set standards etc."

5.139 Throughout the time that Dr Bottrill was in practice no laboratory performance standards were in force. This was recognised by the Health Funding Authority when, as a result of the under-reporting at Gisborne, it came to review the performance of other laboratories. It identified certain factors relating to the Programme including:

"The lack of specific standards or targets for cervical cytology in New Zealand during the period covered by … [the] review.[1990-99];

5.140 The Government Policy for National Cervical Screening 1991 provided that performance indicators for area health boards were to be developed by the Department of Health and negotiated with area health boards. The 1993 updated Policy provided that performance indicators for regional health authorities would be developed by the Ministry of Health and Public Health Commission and negotiated with regional health authorities. In the course of the Inquiry the Committee’s attention was never drawn to the performance indicators for area health boards. The Committee considers that it can be safely assumed that if such indicators had covered laboratory performance then they would have been brought to the Committee’s attention. As regards performance indicators for regional health authorities, these were specified in the funding agreements and related purely to waiting times for colposcopy examinations, enrolment of women and improving access to screening and treatment services. No performance indicators were ever developed in relation to laboratory reading of cervical cytology. It is clear to the Committee that the provision in both Policies for the development of performance indicators, which the Committee assumes to be a diluted version of quantitative performance standards, was recognition that some measure of performance was necessary to enable the Programme to be monitored and evaluated. It is unfortunate that nothing was done to develop performance indicators for measuring laboratory performance.

5.141 Ms Glackin told the Committee that she considered it was not true to say there were no standards for the Programme. She accepted that there were no quantitative performance standards. However, she said this did not mean there were no standards in place. She pointed to the National Cervical Screening Programme Policy of 1996, which she said had expectations in a large number of areas associated with the Programme. Inevitably it seems to the Committee that responses from witnesses may turn on semantics. To the Committee an expectation is not a standard. A standard is something which must be adhered to and which is capable of being enforced. When it came to laboratory performance there was nothing of this nature in place throughout the time Dr Bottrill was in practice, and even after that time. It is only since the Health Funding Authority commenced working on setting performance standards that standards, which are capable of measuring performance and being enforced, have been formulated. The 1996 Policy, which came into effect after Dr Bottrill had retired did not contain compulsory standards capable of measuring laboratory performance.

5.142 The Committee considers that the failure from 1990 to 1996 to impose performance standards on laboratories reading cervical cytology is a factor that is likely to have led to the unacceptable under-reporting in the Gisborne region. Without performance standards the laboratories could not be adequately monitored, and, therefore it was impossible to be sure that they were reading cervical smear tests adequately. Furthermore, a requirement to meet set performance standards would have been a signal to Gisborne Laboratories that laboratory performance could be measured against those standards. Performance standards coupled with sanctions for failure to meet the standards would have caused Gisborne Laboratories either to improve its practices or to cease reading cervical cytology.

No Reliable Data

5.143 For the effective operation of a screening programme it is essential to have timely and reliable data available. This enables an analysis of the Programme’s performance to be undertaken. Within this context the availability of reliable data on laboratory performance in reporting cervical smear tests enables those who are responsible for the Programme to detect if any misreporting is occurring. If the data is made available to laboratories it enables them to analyse the quality of their performance and to discover errors. The importance of statistical data for monitoring and evaluating a cervical screening programme was recognised in World Health Organisation Bulletin of 1986 titled Control of Cancer of the Cervix Uteri; the World Health Organisation’s Cervical Cancer Screening Programmes Managerial Guidelines of 1992 and the European Guidelines for Quality Assurance In Cervical Cancer Screening. The last publication sets out 18 different tables for tabulating data required for monitoring a cervical screening programme.

5.144 Throughout the time that Dr Bottrill was in practice, no reliable data on laboratory performance was available. This meant that Dr Bottrill never received any information from the Programme that could have alerted him to the possibility that he was under-reporting an unacceptable number of cervical smear tests. Dr Bottrill told the Committee that he thought he was detecting a reasonable number of high-grade abnormalities each year.

" Q: … you didn’t know how your results compared with anybody else did you?

A: No

Q: In 1995?

A: I didn’t. However, I was seeing about 30 high-grade lesions a year and without knowing any statistics it seemed a reasonable sort of number for the population we were dealing with. I can’t go any further than that because the figures just weren’t available.

The lack of statistical data also meant that those responsible for the Programme were unable to detect if any of the laboratories reading cervical cytology were misreporting the results.

5.145 The National Cervical Screening Programme was unable to produce reliable data for the period before 1993 because no meaningful data could be derived from the "opt-on" registers then in use, due to the number of registrations not providing a sufficient sample of the population. Secondly, until the 14 stand-alone registers were reconfigured into a centralised register the data was not reliable due to the confounding effect of women being recorded on more than one register. Ms Grew told the Committee that when she was national co-ordinator she could recall some early statistical information on laboratory performance. However this information had not been published and she agreed that it was because the data was not considered to be sufficiently robust. When the Committee asked for a view from the past national co-ordinators about whether or not there had been minimal monitoring and feedback provided by the Programme Ms Grew’s response was:

Ms Grew "I’m just struggling to remember that data that I referred you to earlier, that laboratory data – I do recall there was concern obviously because then numbers were so small and it was decided definitely not to publish them but I may be wrong, but I understand each laboratory was going to get its own but I don’t know what – I can’t imagine what value it could have been, given there was not the ability to sort of compile a national average or anything like that that was reliable."

5.146 It was not until 7 August 1996, by which time Dr Bottrill had retired from practice, that statistical information about laboratory performance in the form of the 1996 National Cervical Screening Programme Statistics first became available. The forward to these statistics recorded that it had always been the intent of the Programme to provide laboratories with information, but that until recently the Programme had insufficient data to allow meaningful analysis for most laboratories. These statistics were intended to provide an analysis of all cervical smear tests stored on the Registers to the period June 1994. The evidence the Committee heard was that information began to be recorded in 1990, therefore, it can be assumed that the 1996 statistics cover the period 1990 to 1994.

5.147 The period from 1990 to 1994 was a time when Dr Bottrill was practising at Gisborne Laboratories. Therefore, the statistics are relevant in that they provide a reflection of Dr Bottrill’s performance in comparison with other laboratories. The forward to the statistics stated that:

"The intent of the report is to provide information to be used in the your [sic] laboratory’s quality assurance processes. One of the NCSP’s major principles has been the implementation and emphasis on quality assurance with the aim to reduce the number of false negative results." (emphasis added)

5.148 Interestingly, the statistics place Gisborne Laboratories’ reporting rates within the acceptable range. They recorded that 86% of the smears read at Gisborne Laboratories were reported as being within normal limits. The average rate for community laboratories making these reports was 80.9% and the range was 68.7-94.7%. Gisborne Laboratories was recorded as having reported 0.6% of abnormalities with high-grade codes. The average rate was 0.8% and the range was 0.4%-2.0%. Thus, if Dr Bottrill had received these statistics while he was in practice, they would have shown him that there was nothing exceptional or unacceptable about his reporting rate. They would have given him no cause for concern about the accuracy of his reporting. Indeed they are likely to have reassured him that his performance was competent.

5.149 However, in the course of the Inquiry the Committee has been told by a number of witnesses that the 1996 National Cervical Screening Programme Statistics were unreliable. Mr Du Rose of the Health Funding Authority accepted that they were unreliable and said he would not put a lot of weight upon them. He accepted that, in a national monitoring exercise, they would not have been a helpful indicator. He also agreed that they could be falsely reassuring. For example, Dr Bottrill’s false negative rate was within the acceptable range and it was not the lowest rate recorded. Mr Du Rose also accepted that the statistics may well have been falsely reassuring to members of the Royal College of Pathologists of Australasia when issues were raised about whether or not there should have been a review of cervical cytology from the Gisborne region.

"Q Given that it is accepted that there will always be false negatives in cytology, reading a statistical report which shows that generally the readings from the laboratory within a certain period of time have been within the range, again could be falsely reassuring, it could make you think if there was a problem with a couple of slides, its just a false negative problem, as opposed to a bigger problem, do you agree?

A Yes, its possible, yes. I think it also points to the lack of not having something where you are actually measuring against."

"Q From the perspective of a pathologist working a laboratory presumably not thinking a lot about statistical information all the time, having a document like that (the statistics) come in through the mail to him, looking at it seeing that his reporting rate is within a similar range to other laboratories, I suggest that it’s likely to reassure him that his practices are okay, rather than to signal to him there could be a problem.

A Yes I agree."

5.150 Professor Skegg was also critical of the 1996 National Cervical Screening Programme Statistics. He was concerned that the statistics took no account of the underlying prevalence of cervical cancer; they did not record whether or not the cytology diagnoses were accurate; as at June 1994 fewer than 50% of women eligible for screening were recorded on the Register/s. He said that the opt-on character of the Registers may have confounded the data, as in his view, the type of women who opt-on to a register have been found to be at a lower risk of cervical cancer than those who do not choose to go onto a register. He also said that the data were based on the number of smear tests which were reported in different ways and not on numbers of women. This meant that no account was taken of the presence of more than one smear test for the same woman. Variations in medical practice could mean that in a particular circumstance some clinicians would take more than one smear and others would not. If two smears were taken from the same woman within a short timeframe, and they were both reported as abnormal, this would influence the overall proportion of smears reported as high-grade. Professor Skegg was very critical of statistical analyses based on the numbers of smears rather than numbers of women:

" I think analyses based on the numbers of smears rather than numbers of women are fraught with problems."

5.151 Professor McGoogan also found the 1996 National Cervical Screening Programme Statistics unhelpful. She considered that no conclusions could be drawn from them:

"Q What are your concerns about this document?

A Well it’s not clear whether this is cumulative year on year data or whether it refers to a shorter period of time. In an opt-on register situation the early years are likely to have fewer smears than later years. Laboratories reporting fewer than 1,000 smears are excluded. If a laboratory reported 1,000 in the last six months it would be excluded from the starter. I note it doesn’t tell me whether – this is a smear collection statistic, it doesn’t tell me anything about women – about whether you have had one smear per woman or ten smears/women in this period of time. If there had been repeated smears from normal women at six monthly intervals for example, it could sway the results. The corollary is if we were reporting smears from the women with high-grade abnormality as she passed through different caregivers, but the smears were sent to the same laboratory, that would also skew the results. Unless the statistics are collected in such a way to avoid these biases then it is difficult to make any comparisons between laboratories simply by looking at smear numbers. I am also concerned that the community laboratory range starts at naught (zero) for various things – I’m not sure how meaningful therefore the range is as a means of comparison of the laboratory in question."

Q You are saying then that without some standardisations and explanations of the data collected and who the population is, it is not very beneficial.

A I don’t think you can draw any conclusions from it. In the UK for example there are some colposcopy services who prefer to take a repeat cervical smear the first time they see a woman in the clinic. Laboratories are required to remove those from their reporting profiles so they are not duplicating two abnormal smears from one woman in their reporting profiles before they submit their statistics, so that they don’t build in a bias, so its very important when collecting the statistics that you collect the same thing from each laboratory or at least you know when you are not."

5.152 It was the lack of statistical information which had a negative impact on the performance of Gisborne Laboratories and that is a factor that is likely to have led to under-reporting. The 1996 statistics had no impact on the practice at Gisborne Laboratories as they did not become available until after Dr Bottrill had retired. They did, however, have a negative impact when it came to deciding if a review of all of the smears read at Gisborne Laboratories was necessary. Their impact on the Royal College of Pathologists of Australasia is most concerning. When the Health Funding Authority sought the views of the College on a review of the cervical smear tests from the Gisborne region the College’s response was influenced by the 1996 statistics. It used these statistics to compare the rates at which different laboratories around the country had reported abnormalities. Because Gisborne Laboratories’ rate was not significantly different from the national average, and because Gisborne Laboratories did not have the lowest reporting rate, the College went so far as to say:

"Dr Bottrill exceeded the performance of almost one fifth of Australian laboratories judged by today’s standards."

At the time the College was unaware of the deficiencies in these statistics. It was only in the course of the inquiry when a number of expert witnesses were asked to look closely at these statistics and to comment on their usefulness that their unreliability was recognised. However, the detrimental influence the statistics had on the judgment of the College when it came to advise on the need for a review shows how dangerous and damaging unreliable statistics can be. If the Health Funding Authority had decided to follow the College’s advice there would have been no review of the smear tests by Douglass Hanly Moir Pathology and the unacceptable level of the under-reporting at Gisborne Laboratories may not have been revealed.

5.153 Apart from the 1996 National Cervical Screening Programme statistics which were sent to each laboratory, there were a total of four official statistical reports for the Programme which the Ministry published. Three of these were general reports and the fourth was a Maori statistical report. The first statistical report was dated 18 August 1992 and it was released in August 1993. The second statistical report was an analysis of data to 30 June 1994 and it was released in October 1995. The third statistical report was an analysis of data to 31 December 1995 and it was released in 1998. The Committee was interested to hear how helpful these statistical reports would be to a pathologist wanting statistical data to determine whether or not his or her laboratory was providing a quality service in terms of smear reading. The Committee was told by Professor McGoogan that she would not have found any of the three statistical reports helpful.

"Q First, can you tell me as a pathologist, are those reports – would those reports be helpful to you in deciding whether or not you were happy with the performance of smear reading in your laboratory?

A It wouldn’t help me at all."

5.154 Professor McGoogan was then questioned about the timeliness of the data. Professor McGoogan informed the Committee that it was important for a pathologist to receive statistical information which was close enough to the period of time for which the analysis was made to allow the pathologist to make adjustments to his or her performance. She considered that an annual supply of statistical analysis of a laboratory’s performance was appropriate. Her reaction to the timeliness of the three statistical reports differed. In her view the first statistical report was understandably the best that could be delivered at that particular time, given the nature of the opt-on register, and also it was delivered a year after the period for which the analysis was made which was not unreasonable. The second report was delivered in October 1995, which was two years later, but it dealt with data to June 1994, therefore there was a 15-month delay in delivering the information. Professor McGoogan described this as "not too bad but drifting out from what is being helpful if one thinks that a practice needs to be improved or adjusted". She also pointed out that if other statistical information needed to be collected, it was already too late to do so, and as the second statistical report was delivered in October 1995, any new or better statistics could only be collected thereafter. She was particularly disappointed with the third statistical report. Her description of this report was as follows:

"It is extremely disappointing that the third report, which dealt with analysis of data up to the end of December 95 took until June 98 to be delivered. It’s further disappointing that the quality of the statistical information leaves a lot to be desired and the authors of the report have done their best to identify the limitations of the quality of the information in the report. While producing the statistics, it’s simply telling you what the data is on the Register, but not saying it is perfect, so how do you interpret it?"

"Q As a pathologist wanting to measure the performance of your laboratory how helpful are each of these reports?

A Not very helpful, particularly the last one is very unhelpful."

5.155 Professor McGoogan did not evaluate the Maori statistical report. She did, however, comment that the bigger the database the more accurate the conclusions drawn from it, and the smaller the database the more difficult it is to derive meaningful and significant statistics. She, therefore, thought the numbers in the Maori statistics may not be large enough and, although of interest to Maori to see what was happening to them, there may have been insufficient numbers to allow meaningful conclusions to be drawn. When asked by the Committee to comment on the fact that the Maori statistical data was at least four years old when first published in the Maori statistical report, Professor McGoogan’s response was:

"It may have been useful four years ago, but it doesn’t tell you whether things are different now, better now, or worse now, and we need to know what’s happening now."

5.156 The Committee learnt that annual statistical reports were intended. However, their publication was hampered by the difficulties that the Programme encountered in obtaining reliable data. This was due to the fragmentation that resulted from having 14 stand-alone registers. Secondly the involvement of 14 area health boards had a detrimental effect. The Committee learnt that some of the area health boards altered the software of the registers in their regions and this affected the collection of statistical data. Secondly the number of area health boards allowed room for divergence in viewpoints to arise which led to actions differing from region to region. For example the first statistical report, which was released in August 1993 and which presented data to 18 August 1992, was first of all delayed, because the Wellington Area Health Board would not provide data from its region, and finally the report was published without data from Wellington. The release of the Wellington data was held up by the security protocols of the Wellington Area Health Board’s Ethics Committee. Furthermore, the Programme delayed issuing a second statistical report until the Wellington data became obtainable. The second statistical report was released in October 1985 and it presented data to June 1994. It could not present data beyond that date because no data from the Auckland Area Health Board region was available beyond June 1994. The third statistical report was released in June 1998 and it presented data to December 1995. Professor McGoogan, Professor Skegg and Dr Cox were critical of the statistical reports in terms of their limited value for methodological reasons, and also because the data was well out of date by the time the reports were published. When those criticisms were put to Ms Grew her response was that not having one database made it very difficult to produce statistical reports. Her view was the first statistical report was affected by lack of data, but she thought that subsequently it should have been possible to have got into a routine, and once there was only one database it should have been "really easy to produce an annual report or even three monthly, six monthly". Ms Grew was then asked to explain from her perspective as a former national co-ordinator of the Programme why it was that only three general statistical reports had been produced. She could not offer an explanation. Ms Dahl said that until the register was reconfigured into one database it was too difficult.

"Q From your perspective are you able to explain why there have only been three statistical reports in the period?

A – Ms Grew I can’t explain that.

A – Ms Dahl I can explain it was very difficult to do the second statistical report and that related to the fact that we did have 14 registers at the time. We had to create programs to get the information downloaded at the 14 sites and compiled in Wellington so that we could do that reporting. I would have envisaged that once we had the register reconfigured that the data would be more readily available and it would have been an easier thing to do."

5.157 There was also no compulsory requirement to report incidences of cancer and deaths from cancer until the passing of the Cancer Registry Act 1994. An effective Cancer Registry is essential to enable a screening programme to be monitored and evaluated. One way of testing the effectiveness of a screening programme is to carry out an audit of the cases of cancer by retrospectively investigating the smear history and clinical treatment of the women concerned. To do this there needs to be a reliable record of the number of cases of cancer. On 5 April 1990 the Expert Group wrote to the Minister of Health advising her of the urgent need for up-to-date statistical information on cancer cases. The letter stated:

" The Expert Group is resolved that it is impossible for it to adequately perform its task if the Cancer Registry is not adequately functional. The Expert Group therefore recommends as a matter of urgency the Cancer Registry is resourced with equipment, staff and legislative framework to provide a complete up-to-date and confidential registry of all cancers and cervical dysplasias in New Zealand."

Ms Gillian Grew who was the first national co-ordinator of the Programme was asked if she was aware of the Expert Group’s views and whether or not she agreed with them. She said she was aware of their views and she agreed with them:

"Q Were you aware that the Expert Group had that concern and what to your knowledge was done about it?

A Ms Grew: I was aware when I arrived in the department that they had a concern and there was quite a lot of work going on to actually secure the future of the Cancer Registry at that time.

Q Do you agree with the sentiments in the letter

A Certainly. "

5.158 Other experts from whom the Committee heard evidence also thought that a cancer registry was necessary for the Programme to function effectively. Furthermore, this type of advice in various forms was both available and given to the Department of Health during the developmental stages of the Programme. This is stated in the World Health Organisation Bulletin of 1986 titled Control of Cancer of the Cervix Uteri; the World Health Organisation’s Cervical Cancer Screening Programmes Managerial Guidelines of 1992 and the European Guidelines for Quality Assurance In Cervical Cancer Screening. However, it was not until 1994 that the legislation setting up a cancer registry with mandatory reporting provisions was passed. Since then there have been problems with the completeness of the Cancer Registry data. In addition during the course of the Inquiry the Committee learnt that the Cancer Registry was not releasing data in accordance with the law and was imposing an unnecessary obstacle by requiring compliance with the Health and Information Privacy Code, even though the Code had no application to processing requests for Cancer Registry information.

Failure To Conduct Any Comprehensive Exercise To Audit, Monitor And Evaluate The Performance Of Laboratories Reading Cytology

5.159 It is important to be clear about the meaning given to the words "auditing," "monitoring" and "evaluation" as their meaning can differ depending on the user. The Committee has chosen to adopt the definition of these words that is set out in exhibit JMP/HFA/0023, the November draft of the Health Funding Authority’s Evaluation and Monitoring Plan for the National Cervical Screening Programme. "Monitoring" means:

"…the continuous supervision of an activity for the purpose of checking whether plans and procedures are being followed.

Within the meaning of "monitoring" is the act of "auditing" which is:

"a subset of monitoring and …[is] an investigation into whether an activity meets explicit standards, as defined by an auditing document, for the purpose of checking and improving the activity audited

"Evaluation" means:

" a comparative assessment of the value of an intervention, in relation to criteria and using systematically collected and analysed data, in order to decide how to act.

"….other purposes of evaluation …[are]:

a systematic way of learning from experience and using lessons learnt to improve current activities and promote better planning by careful selection of alternatives for future action.

Programme evaluation is a diligent investigation of a programme’s characteristics and merits. Its purpose is to provide information on the effectiveness of projects so as to optimise the outcomes, efficiency and quality of health care."

Throughout the time that Dr Bottrill was in practice, and subsequently, the National Cervical Screening Programme has not carried out a comprehensive evaluation of its overall performance, including the performance of laboratories reading cervical cytology. Nor has it monitored the performance of laboratories reading cervical cytology. The Ministry of Health took steps in 1995 to have a national evaluation of the Programme carried out by an independent team of experts but as at September 2000 this national evaluation was incomplete and there are uncertainties still as to when, and in what form it will be completed.

5.160 When the Health Funding Authority recognised that the level of under-reporting at Gisborne Laboratories suggested there was a significant problem with its smear test reporting, the Health Funding Authority reviewed the cervical cytology of other laboratories which it had identified as being potential poor performers. This exercise was a response to the problem that had arisen in the Gisborne region and, although it provided information of a type which could come from a monitoring exercise, it can not be seen as having been undertaken for the general purpose of monitoring and evaluating laboratory performance. The Health Funding Authority acknowledged this in its published report titled Review of Cervical Cytology Practice in New Zealand Community Laboratories: 1990-1999. The Review states: "…this review does not represent a thorough assessment and evaluation of the quality of cervical cytology services."

5.161 The Committee considers that the failure to set up from the outset a National Cervical Screening Programme with performance standards in place and with a means of gathering reliable statistical data to enable laboratory performance to be monitored and evaluated adequately are factors that are likely to have led to Dr Bottrill’s under-reporting of cervical smear tests. The Programme’s lack of performance standards for reading cervical cytology, and the absence of reliable data, made it difficult to monitor and evaluate laboratory performance adequately.

5.162 The importance of monitoring and evaluation is made clear in the World Health Organisation Bulletin of 1986 titled Control of Cancer of the Cervix Uteri which states: "A cervical cancer control programme should not be initiated prior to the establishment of adequate evaluation procedures. It is essential to assess progress of the screening programme periodically both from the procedural standpoint, to determine how effective the operations actually are, and in terms of achievement, to analyse the extent to which morbidity and mortality have been reduced in the population group covered." The need for reliable data in order to monitor and evaluate is clearly spelt out in the literature on cervical screening programmes. The World Health Organisation’s Cervical Cancer Screening Programmes Managerial Guidelines of 1992 state: "For evaluation and monitoring purposes the data must be maintained in a form that permits identification and linkage at an individual level, and the information system should be so designed that it is accessible for such purposes.". The European Guidelines for Quality Assurance In Cervical Cancer Screening state that: " Before cervical screening can be implemented mechanisms for gathering essential data for the day to day operation of the programme and for statistical purposes must be in place."

5.163 However, the lack of reliable data and performance standards should not lead to nothing being done. When the Health Funding Authority had to carry out the Review of Cervical Cytology Practice in New Zealand Community Laboratories: 1990-1999 it overcame the absence of performance standards by focusing "on the assessment of risk to women by examining markers of possible under-reporting of abnormalities." It recognised that this type of exercise did not enable a thorough assessment and evaluation of quality in laboratory performance to be carried out. Nevertheless, it allowed the Health Funding Authority to obtain some information about the performance of other potentially poor-performing laboratories. However, in the case of the National Cervical Screening Programme even this type of evaluation was not carried out.

5.164 It is of course possible that once the 1996 Cervical Screening Programme Statistics on laboratory performance became available any evaluation of Gisborne Laboratories’ performance, which covered the period prior to March 1996, may have failed to detect under-reporting. Those statistics placed the laboratory’s reporting rate within what the Programme was treating as an acceptable range. The Committee heard expert evidence that this information was misleading. This highlights the danger of attempting to monitor a programme by poor methods. However, if the Programme had monitored and evaluated laboratory performance adequately from an early stage, even by looking for indicators of under-reporting as the Health Funding Authority did, the extent of the under-reporting of cervical smear tests at Gisborne Laboratories may have been detected much sooner. This would have reduced the number of women affected by misread cervical smear tests.

5.165 The Committee has already commented on the failure to develop the performance indicators to which the Policies of 1991 and 1993 referred. Both Policies in their sections on evaluation and monitoring refer to the development of performance indicators. The Committee has interpreted this reference to performance indicators as an acknowledgement that some means of measuring performance was essential to enable the Programme to be monitored and evaluated. Nevertheless, no performance indicators were developed for the purpose of measuring laboratory performance.

5.166 The Ministry of Health maintained that some monitoring of the Programme was undertaken, although they conceded that this monitoring gave no information on laboratory practice. The Ministry also conceded that the National Cervical Screening Programme had never been subject to a comprehensive evaluation. At the outset of the Programme, when it came to laboratory practice in reading cervical cytology there was a complete reliance on the professional integrity of the medical practitioners responsible for the performance of this service. No attempt was made to ascertain the accuracy of the practitioners and those working under their supervision in reading cervical smear tests. Although, at this time the Social Security (Laboratory Diagnostic Services) Regulations 1981 were in force, there was no attempt to utilise the authority they gave to inspect laboratory equipment and apparatus in order to check on laboratories’ performance. The Committee realises that the Ministry of Health now submits that this part of the regulations is ultra vires. It will deal with this submission under term of reference three. Nothing changed after the health reforms in 1993; laboratory practice in reading cervical cytology was neither monitored nor evaluated.

5.167 Both the 1991 and 1993 Policies provided that the National Co-ordinator would be responsible for ensuring that the National Cervical Screening Programme was monitored and evaluated nationally, and that evaluation of projects and services nationally would be co-ordinated by the Department of Health and subsequently by the Ministry of Health. The Policy also provided that on a regional level it was the responsibility of the area health board and subsequently the regional health authority to monitor and evaluate the Programme in their area. However, Mr Mules of the Midland Regional Health Authority told the Committee that the Midland Regional Health Authority could not carry out this role as it did not have access to the necessary information to enable monitoring and evaluation to take place. The information was held by the Department and then subsequently the Ministry of Health. Once again, it seems to the Committee that the design of the Policy did not reflect accurately the capability of those given responsibilities under the Policy to discharge that responsibility.

5.168 What is of most concern to the Committee, however, is the failure of the Department of Health and subsequently the Ministry of Health to monitor and evaluate the Programme at a national level. Under the Policy the National Co-ordinator was made responsible for ensuring that national monitoring and evaluation took place. However, it is clear from the job description of the National Co-ordinator and from the evidence the Committee has heard of the role, that she had no authority to ensure that the national monitoring and evaluation of the Programme was in fact carried out. The Committee considers it is a design flaw of the Policy that it gave a responsibility to the National Co-ordinator without ensuring that she had intrinsic or extrinsic power to discharge that responsibility by requiring national monitoring and evaluation to be carried out. Secondly, the Policy imposed a responsibility on the Department of Health and subsequently the Ministry of Health to co-ordinate the monitoring and evaluation of the Programme. Again, the evidence shows to the Committee that the Department of Health and subsequently the Ministry of Health was unable, sometimes for practical reasons and other times for legal reasons, to discharge this responsibility. The end result was that although both Policy documents made provision for monitoring and evaluation of the Programme at a national level, including the monitoring and evaluation of laboratory performance, it never occurred during the time that Dr Bottrill was in practice. Indeed, from the evidence the Committee has received it seems that the first attempt to carry out a national comprehensive evaluation of the Programme is still incomplete. Dr Peters, who gave evidence for the Health Funding Authority is the manager of the unit in which the National Cervical Screening Programme has been housed since 1998. She accepted that there still has not been a comprehensive evaluation of the national Programme.

"Q Dr Peters, I understand that you accept that at the moment there has been no comprehensive evaluation of the nation Programme, is that correct?

A Yes."

5.169 She also informed the Committee that from her perspective, quality standards and monitoring and evaluation were just beginning.

"Q In respect of bringing in quality standards, monitoring and evaluation, are you really starting from scratch with the programmes in terms in that aspect of it?

A Well I feel as though I am."

5.170 The Committee has learnt that there has never been an audit of cases of cervical cancer even though this is considered to be one of the most effective ways of measuring the effectiveness of a cervical screening programme. As early as 1986 the World Health Organisation in its bulletin on Control Of Cancer Of The Cervix Uteri had stated that:

"Screening programmes can be evaluated by their failures. Cases of symptomatic invasive cancer of the cervix, and especially of advanced disease can be regarded as failures of a screening programme. Knowledge of the age distribution of such cases and of their screening history provides information of the effectiveness of the programme in reaching the intended age groups and the quality of the screening being carried out."

This form of monitoring and evaluation is particularly useful when a cervical screening programme has no performance standards in place, however, it does depend on access to reliable data on cancer incidence and mortality and smear test history. Apart from the World Health bulletin the Committee was informed by: Professor McGoogan, Professor Skegg, Dr Medley, Dr Peters, Dr Cox and Dr Teague that an audit of cases of cervical cancer was the gold standard for measuring the effectiveness of a cervical screening programme.

5.171 Such an audit has never been carried out in New Zealand. An attempt has been made to carry it out as part of the national evaluation of the programme, but that has run into legal and ethical obstacles. Ms Glackin acknowledged the difficulties that had prevented this exercise from being carried out in New Zealand and said that Ministry of Health officials had understood that ultimately this exercise would be carried out routinely.

"I don’t think there is any disagreement about the advice that following people with cancer through was a gold standard in relation to treatment. And in the light of that I’m not sure what people – whoever was dealing with this - felt in 1993, but you would have expected that issue might have been addressed then.

5.172 If the Programme had carried out an audit of cervical cancer cases by looking back at the cervical smear history of women who had developed cervical cancer and investigating those who were registered as having normal smear tests within a set time frame, such as five years prior to diagnosis, that is likely to have alerted the Programme to the likelihood that there was an unacceptable level of under-reporting in the Gisborne region. However, for reasons which will be covered in term of reference three, it appears that access to the register for this purpose has not been permitted. In any event it was not until December 1999 that the Ministry realised there was a legal barrier to using the register as an audit tool. This indicates to the Committee that no meaningful attempt had been made to use the register in this way before then:

Question: The evidence of, certainly Dr Cox was that this clinical audit or retrospective look at women who developed invasive cancer should, as Ms Glackin said, be a routine occurrence. Would you accept that if that had occurred early on in the Programme the problems with s.74A would have been understood much more quickly than it has been now"

Answer Ms Glackin: I would, but I should make the comment that from a technical perspective there are issues with having, apparently, sufficient numbers of women enrolled to make evaluation feasible. One of the issues with this programme is that until after the opt-off in 1993 we had quite small numbers. So I understand there were some technical issues about when the evaluation could be done.

This comment from Ms Glackin indicates the major difficulties the Programme faced. Evaluation was not possible before the Register became an opt-off single database. Once it could be used for evaluation, which was by 1997 when it was reconfigured and had sufficient numbers of women registered to provide meaningful data, the Ministry discovered that s.74A of the Health Act 1956 posed a barrier to using the Register for this purpose. The outcome is that during the time Dr Bottrill was in practice the Register could not be used effectively to allow laboratory performance to be monitored.

5.173 In June 1996, which was after Dr Bottrill had retired a new Policy for the Programme was published. This Policy is relevant because if it had been designed to ensure that the Programme was effectively monitored it would have revealed the extent of Dr Bottrill’s under-reporting earlier than has happened and this may have meant that the high-grade abnormalities or cervical cancers of some women were detected earlier and therefore they may have been more responsive to treatment.

5.174 Like the earlier Policies the Policy of 1996 provided that the main responsibility of the Ministry of Health was to monitor and evaluate the National Cervical Screening Programme and to monitor and analyse the state of public health regarding the incidence of cervical cancer and associated risk factors in New Zealand. The Policy also provided that regional health authorities were responsible for monitoring and evaluating the Programme in each regional health authority region. Once again, there was the difficult tension between the Policy’s placement of responsibility for national monitoring and evaluating on the Ministry of Health with the responsibilities the funding agreements imposed on regional health authorities. Ms Glackin said to the Committee that under the 1996 Policy it was a requirement on the Health Funding Authority to purchase the Programme in line with that Policy. However, the impact of the split accountability between the Ministry of Health and the Health Funding Authority and the design of the 1996 Policy meant that the regional health authorities left monitoring and evaluating to the Ministry of Health.

"Q The difficulty was that, Ms Glackin, we had evidence from Mr Mules that the regional health authorities considered that under the 96 funding agreement responsibility for monitoring and evaluating the Programme remained with the Ministry of Health, and he referred to that in his evidence to say this is why, as far as he was concerned, the Midland Regional Health Authority did not consider that it had to do that because it was looking at the screening policy documents and under those policy documents responsibility for monitoring and evaluating the Programme remained with the Ministry of Health.

A – Ms Glackin Yes, and that issue of split accountability was actually canvassed in the 1996 review. I think the Ministry has no difficulty with recognising the problems that arose from that division. I would just make a point though in relation to evaluation that the Ministry initially put funding in its budget and began initial work on a formal evaluation in 1996."

It should be noted that the formal evaluation that Ms Glackin speaks of is the one that is still to be completed.

5.175 Ms Glackin told the Committee that the evaluation was first discussed in 1995 and the Ministry decided to proceed with a national comprehensive evaluation in 1996. Tenders were put out and in January 1997 a contract was signed with the University of Otago for a scoping of the evaluation. The first draft of the evaluation was received in May 1997 and that proved to be too expensive. There was then much consultation about what should occur. Ultimately a shortened form of evaluation was agreed covering three specific areas and a contract to carry that out was signed with the Ministry in May 1999. As at 6 August 2000, when Ms Glackin was giving her evidence to the Committee, of the three areas to be evaluated one had been completed, one had received Ethics Committee approval three weeks earlier, and the third, which was the audit of cervix cancer incidence and mortality, was not proceeding because of the difficulties in gaining access to information. Had a national evaluation been carried out anytime after Dr Bottrill’s retirement in March 1996 it ought to have detected earlier the unacceptable level of under-reporting in the Gisborne region. That knowledge should have led to women receiving treatment earlier on and it may have avoided cancer mortality or severely invasive treatment for cancer.

5.176 Without monitoring and evaluation it is impossible for a pathologist to be aware of the accuracy of his or her reading of cervical cytology. All screening programmes that involve analysis of cellular material are dependent upon the accuracy and competency of the practitioner responsible for reading the cellular material. Unless the practitioner’s work is monitored and evaluated mistakes are not likely to be detected until the deteriorating health of the screening subject causes the practitioner’s work to be reviewed. By that time it can often be too late to cure the patient, or if the disease is still curable severely invasive treatment may be required to achieve a cure.

5.177 The success of the National Cervical Screening Programme depended on pathologists and other laboratory workers reading cervical smear tests competently and accurately. If the Programme had monitored the performance of laboratories reading cervical cytology the unacceptable level of under-reporting at Gisborne Laboratories would have been detected much earlier on and, therefore, fewer women would have been harmed. Furthermore, the information gained from monitoring laboratory performance could have been used to inform Gisborne Laboratories that the cervical cytology read at the laboratory was not being read competently. As it was, throughout the time that Dr Bottrill was in practice at Gisborne Laboratories, neither Dr Bottrill nor any other director or officer of the company was provided with information, from any Crown body or agency responsible for the Programme, which would have informed them that there was an unacceptable level of under-reported cervical smear tests. The Committee considers that to run a screening programme that is dependent on laboratories performing their role competently without providing them with any feedback on their performance, is a factor that can lead laboratories to under-report the tests they carry out. Consequently it considers that the failure to provide this information to laboratories is a factor that is likely to have led to the under-reporting at Gisborne Laboratories.

Failure To Take Heed Of Overseas Screening Failures

5.178 Between 1993 and 1994 there were three incidents overseas of a laboratory causing a failure in a cervical screening programme by under-reporting cervical cytology. These incidents occurred in Australia and the United Kingdom. The Cervical Screening Advisory Committee brought these screening failures to the attention of the National Co-ordinator of the Programme and the Ministry of Health, and they were published in the National Cervical Screening Programme’s newsletters. In addition in June 1994 a hospital pathologist at Goodhealth Wanganui was found to have misread biopsy specimens. The pathologist was 62 years of age and had been diagnosed with Parkinson’s Disease in late 1993. A review of his work revealed that he did not participate in quality assurance activities; he did not participate in continuing medical education and he was working in an isolated environment. It was recognised that all of these circumstances may have impaired his work as a pathologist.

5.179 Given the information that was available about the mis-reporting in Australia and the United Kingdom, and the findings from the Wanganui investigation it is surprising that neither the Programme nor any other unit within the Ministry of Health initiated a review of New Zealand laboratories reading cervical cytology; particularly those laboratories, like Gisborne Laboratories, which in some respects resembled the practice at Goodhealth Wanganui. The Programme’s staff would have known that laboratory performance in reading cervical cytology had never been properly monitored and evaluated, so that the quality of the laboratories’ performance was not definitively known. These local and foreign incidences of laboratory error were a signal to the Programme that laboratory error can occur and when it did it could have a damaging impact on patients’ health. While the Programme had no direct power to take any action against laboratories it was the entity under the Policy which was responsible for ensuring that the Programme was monitored and evaluated nationally and so in the Committee’s view it should have responded by initiating a review of laboratory performance.

5.180 The overseas screening failures occurred during the time that Ms Dahl was the national co-ordinator. The incidents were noted in the Programme’s newsletter. The Committee learnt from Dr Cox who was on the Cervical Screening Advisory Committee that after the second incident the Advisory Committee advised the national co-ordinator (Ms Dahl) that this type of event could occur in New Zealand and that appropriate quality assurance was needed to minimise the risk of it occurring. Ms Dahl told the Committee that she could not recall Dr Cox specifically saying that at the meeting, but she did recall that at the time she was working with the Advisory Committee to develop quality assurance processes, monitoring processes, and evaluation processes so she said that she could only surmise that it was considered as part of what was being done in relation to that. When asked to comment on why the Programme did not respond to the these incidents by initiating a review of laboratory performance in New Zealand, her response was that the overseas incidences of misreporting had not brought home to the Programme the need for a review.

"Q When I asked Dr Cox whether or not – I asked him both in respect of each article [in the Programme’s newsletter] they provided a wakeup call, and he said they did, and I then said well in view of the first two wakeup calls, once a second had been received what do you think should have happened, and he said as a matter of urgency I would expected a review of laboratory practice processes to reduce the chances of a similar event occurring in New Zealand. What comment do you have on that?

A – Ms Dahl The only comment that I can have is that the wakeup call was not sufficiently loud to have that occur."

5.181 In his evidence Dr Cox referred to a Programme newsletter of January/February 1993 which contained an article on the accuracy of smear tests of 237 women referred to the Royal Hospital for Women in Sydney for invasive cervical cancer. The article noted that a worrying aspect was the number of patients whose previous smears on review showed frankly malignant cells but were originally reported as normal.

5.182 In a second Programme newsletter of March/April 1994 there was an article on a screening failure in Great Britain which described how a group of 2,000 women were recalled in Grennock where smears had been wrongly read for five years in a laboratory described as understaffed, antiquated and isolated. Dr Cox said that the Advisory Committee advised the national co-ordinator that "This type of event could occur in New Zealand and that appropriate quality assurance is needed to minimise the risk of such an event occurring.".

5.183 The Midland Regional Health Authority did respond to the Wanganui incident by writing to all of its laboratory providers including Gisborne Laboratories. In his response Dr Bottrill told Midland that the laboratory had applied for TELARC accreditation in histopathology and cytology, he advised that he did not participate in any external quality control programmes, but said that he did attend at least one national or international conference or course every year. He concluded his letter by stating "There is little likelihood of a major misdiagnosis of the type you refer to in your letter."

5.184 Dr Malpass of the Midland Regional Health Authority judged the response from Gisborne Laboratories to be unsatisfactory and referred it to the Chief Executive, (Mr Mules), to determine what action, if any, should be taken. Mr Mules decided that the Regional Health Authority had no power to refuse to fund laboratory services from Gisborne Laboratories. At the time the legal relationship between the regional health authority and the laboratory was governed by a notice issued under s.51 of the Health and Disability Services Act. Mr Mules believed that the laboratory was not in breach of any of the terms of the s.51 notice and there were no other sanctions that the regional health authority could apply against it. For this reason it seems no action was taken as a result of Dr Bottrill’s unsatisfactory response, and the Midland Regional Health Authority conducted no investigation into his laboratory’s practices or processes.

5.185 The Committee considers that s.51 of the Health and Disabilities Act permitted regional health authorities to issue notices which contained terms and conditions that gave to them the power to require laboratories to adopt quality assurance measures, including TELARC accreditation, and to suspend laboratories from receiving payment if their services were a risk to public health. The Committee’s reasons for reaching this conclusion are set out in the section of the report on term of reference three. It was also possible to change the terms and conditions of s.51 notices on the giving of appropriate notice. Therefore, the Committee considers that the Midland Regional Health Authority should have carried out an investigation of Gisborne Laboratories. If the investigation had shown that action was warranted the Midland Regional Health Authority could then have taken steps under s.51 to change the terms and conditions of the notice to allow for appropriate action to be taken.

5.186 The opportunity, in 1994, which the Programme and the Midland Regional Health Authority had to uncover the presence of unacceptable under-reporting at Gisborne Laboratories was missed, with the consequence that Dr Bottrill continued to practise until his retirement in March 1996. During this time more women had their smears misreported and, therefore, they did not receive the appropriate follow up treatment. In the Committee’s view the failure by either the Programme/Ministry of Health or the Midland Regional Health Authority to follow up the local and foreign incidents of laboratory error which in turn led to a loss of opportunity to discover the under-reporting at Gisborne Laboratories earlier is a factor that is likely to have led to the under-reporting that occurred from 1994 onwards.

Failure To Ensure All Components Of The Programme Were In Place From An Early Stage

5.187 There was a failure to ensure that all the components of the National Cervical Screening Programme were in place from the outset or, alternatively at an early stage in the Programme’s development. If all the missing components had been in place from an early stage in the Programme, that is: reliable statistical data, performance standards, monitoring and evaluation of laboratory performance and compulsory quality assurance of laboratories, they would have prevented Dr Bottrill from practising as he did.

5.188 The need to have all the components of the Programme in place from an early stage was recognised early in the Programme’s development, by the Ministerial Review Committee in its November 1989 report On Implementation Of A National Cervical Screening Programme. The Ministerial Review Committee stated:

"For a cervical screening programme to be successful all aspects must be developed simultaneously as each is an integral part of achieving success."

5.189 Ms Glackin accepted this and told the Committee that over time the Programme had been progressing towards having everything in place.

"Q And do you agree this really reinforces what the World Health Organisation was saying to run a programme effectively you really need to have all aspects in place at once, or if you are building up good data from the cancer register and the screening register and you can make the necessary links, and if you can make the necessary links between cytology and histology all these factors go to help you identify more readily cases where the programme might be failing in respect of under-reporting of smear tests.

A – Ms Glackin I would agree with that, and I think, looking over time what we have been doing is progressing towards that state. I think the Inquiry is well aware of how long various aspects of that have taken. I should perhaps make the point of course which the Inquiry is well aware of, that the cancer registry deals with cancers of all sorts."

However, the progress Ms Glackin referred to is still to be completed. The re-configuration of the Register was completed by 1997 and since that date reliable data should have been available to monitor and evaluate the Programme. Compulsory TELARC accreditation has been in place since 1997. However, there have been other obstacles to surmount. The end result is that even today some of the components are still missing. Reliable data is still hard to access because of legal and ethical barriers and the Programme has still not been comprehensively monitored and evaluated. This is ten years after the Programme was operative in the Gisborne region.

No Compulsory Reassessment Of Medical Practitioners

5.190 There were no compulsory requirements for medical practitioners to undertake formal continuing education, or for them to have their competence reassessed. The Committee considers that this too was a factor that is likely to have led to the unacceptable under-reporting in the Gisborne region. Had Dr Bottrill been required to undergo formal continuing education and a re-assessment of his competency as a medical practitioner it is unlikely that he would have continued to practice as he did. The impact of formal continuing education could well have brought home to him the risk his practices posed to patients. A re-assessment of his competency would most likely have revealed that he was being overly cautious in diagnosing abnormalities; that he had " calibrated" his eyes to read smear tests with a very high specificity and that he needed to increase the sensitivity of his reporting. The Committee has concluded that Dr Bottrill was unaware of the risk his practices posed to patients. Compulsory participation in a formal course of continuing education and re-assessment of his competence should have remedied this. For this reason the Committee has concluded that the absence of any requirement to participate in continuing education or any formal re-assessment of competency are factors that are likely to have led to the unacceptable under-reporting in the Gisborne region.

Conclusion

5.191 The Committee has identified those factors directly relating to Dr Bottrill’s practice which it considers are likely to have led to unacceptable under-reporting in the Gisborne region. It has also identified factors relating to the delivery of cervical cytology services during the time that Dr Bottrill was in practice and afterwards which it considers are likely to have led to under-reporting in the sense that it was the presence of these factors which enabled Dr Bottrill to practise as he did and which meant that the under-reporting was not detected sooner. If Dr Bottrill had not been able to practise on his own, carrying out all the primary screening in circumstances where there was no internal or external quality control at Gisborne Laboratories, and where the laboratory was not registered with TELARC or any other quality control authority, it is unlikely that he would have under-reported for as long as he did and at such an unacceptable level. An effective, well-designed and well-implemented programme would have prevented him from practising in this way. Ultimately, it was the flaws in the National Cervical Screening Programme that permitted Dr Bottrill to practise as he did. In August 1990 the Expert Group’s Policy Statement of the National Cervical Screening Programme recognised that screening can fail because of poor quality in either the smear taking or smear reading. The Policy Statement noted that there had been reports of deficiencies in these aspects of screening in parts of New Zealand. The Policy Statement went on to emphasise the importance of management systems in ensuring that poor quality in smear taking or smear reading did not cause a programme to fail:

"In an organised programme, the management system can minimise the possibility of such failures by measuring the technical quality of the screening process and by monitoring the follow up of women with abnormal smears."

It is unfortunate that the recognition in 1989 of the importance of a screening programme’s management system did not flow through to ensure that it was well designed and well implemented.

 

Back
To Top