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 assu